- Trials with a EudraCT protocol (343)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (4,858)

These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006). | |
Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records. |
Study title: HAB-052 |
Active substance: inactivated hepatitis a virus and hepatitis b surface antigen (rdna) |
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Document reference: 41481 |
Study title: HAB-164 Ext:038 Y10 |
Active substance: inactivated hepatitis a, hepatitis b recombinant, adsorbed, vaccine |
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Document reference: 41612 |
Study title: Evaluation of safety and immunogenicity of inactivated flu vaccine in children with underlying disease |
Active substance: INACTIVATED INFLUENZA SPLIT VIRION VACCINE (TRITON X 100) |
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Document reference: 41289 |
Study title: Immunogenicity and safety of the inactivated, split virion influenza vaccine in high risk children aged from 3 to 8 years |
Active substance: Inactivated Influenza Split Virion Vaccine (Triton x 100) |
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Document reference: 41221 |
Study title: Immunogenicity and safety of the inactivated, split virion influenza vaccine in high risk children aged from 3 to 8 years |
Active substance: INACTIVATED INFLUENZA SPLIT VIRION VACCINE (TRITON X 100) |
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Document reference: 41290 |
Study title: Immunogenicity and safety of the inactivated, split virion influenza vaccine in high risk children aged from 6 to 35 months |
Active substance: INACTIVATED INFLUENZA SPLIT VIRION VACCINE (TRITON X 100) |
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Document reference: 41291 |
Study title: Evaluation of safety and immunogenicity of inactivated flu vaccine in children with underlying disease |
Active substance: Inactivated Influenza Split Virion Vaccine (Triton x 100) without Thiomersal |
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Document reference: 41217 |
Study title: Comparative evaluation of the effects of indomethacin and ibuprofen on cerebral perfusion and oxygenation in preterm infants with patent ductus arteriosus. |
Active substance: INDOMETHACIN |
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Document reference: 29841 |
Study title: Comparison of single and multiple dose pharmacokinetics using clinical bioequivalence data and Monte Carlo simulations. |
Active substance: INDOMETHACIN |
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Document reference: 29846 |
Study title: Reduced Advanced Glycation Endproduct (AGE) Levels in Children on Automated Peritoneal Dialysis (PD) with PD-Fluids Containing Less Glucose Degradation Products (GDPs), 2003 |
Active substance: HYPERTONIC SOLUTIONS |
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Document reference: 29379 |
Study title: A clinical trial to evaluate the efficacy and safety of compound pseudoephedrine hydrochloride sustained release capsule in patients with seasonal allergic rhinitis. Zhonghua Er Bi Yan Hou Ke Za Zhi 2004; 39(9):549-53 |
Active substance: IBUPROFEN |
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Document reference: 29507 |
Study title: Relazione sullo studio di palatabilità di Moment gocce. Valutazione comparativa a Novalgina gocce in soggetti volontari. |
Active substance: IBUPROFEN |
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Document reference: 29455 |
Study title: Immunogenicity and safety of P.M.sv, inactivated split influenza vaccine in children between 6 months and 3 years old |
Active substance: Inactivated Influenza Split Virion Vaccine (Triton x 100) without Thiomersal |
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Document reference: 41477 |
Study title: Immunogenicity and safety of the inactivated, split virion influenza vaccine in high risk children aged from 3 to 8 years |
Active substance: Inactivated Influenza Split Virion Vaccine (Triton x 100) without Thiomersal |
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Document reference: 41474 |
Study title: Immunogenicity and tolerability of the Aventis Pasteur inactivated flu vaccine (IMOVAX GRIPE) in high risk and healthy children aged from 6 to 35 months |
Active substance: Inactivated Influenza Split Virion Vaccine (Triton x 100) without Thiomersal |
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Document reference: 41476 |
Study title: Safety of inactivated split-virion influenza vaccine administered by the intradermal route in healthy children |
Active substance: Inactivated Influenza Split Virion Vaccine (Triton x 100) without Thiomersal |
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Document reference: 45254 |
Study title: Immunogenicity and safety of the inactivated, split virion influenza vaccine in high risk children aged from 6 to 35 months |
Active substance: Inactivated Influenzae Split Virion Vaccine |
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Document reference: 41475 |
Study title: EVALUATION OF A NEW COMBINED INACTIVATED DTP-POLIO VACCINE |
Active substance: Inactivated Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 41181 |
Study title: Almishari MA. (1994). The Gulf Journal of Dermatology [Kuwait]. February,1(1):30-31. Isoprinosine® therapy in varicellaAlmishari MA. (1994). The Gulf Journal of Dermatology [Kuwait]. February,1(1):30-31. Isoprinosine® therapy in varicella |
Active substance: INOSINE |
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Document reference: 30066 |
Study title: Inactivated poliovirus vaccine clinical expertise |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 41184 |
Study title: Large scale safety study of the DTacP-IPV {acellular TETRACOQ®) vaccine, administered in combination (one injection site) or in assocation two injection sites) with Haemophilus influenzae Type b vaccine (Act-HIB®) for primary and booster immunisation |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 41203 |
Study title: Merieux inactivated poliovirus vaccine Final report of clinical studies at Suny/Children's hospital, Buffalo, New York & John Hopkins University, Baltimore, Maryland |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 41187 |
Study title: Merieux inactivated poliovirus vaccine Final report of clinical studies at Suny/Children's hospital, Buffalo, New York & John Hopkins University, Baltimore, Maryland |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 47469 |
Study title: Phase III trial on the persistence of antibodies 5 years after a primo-vaccination and 4 years after a first booster with PENTAVAC® vaccine and the immunogenicity and safery of a second booster with TETRAVAC-ACELLULAIRE® vaccine at the ager of 5-6 years |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 41194 |
Study title: Prevention of typhoid fever in Nepal with the Vi capsular polysaccharide of Salmonella typhi |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 41207 |
Study title: Randomised open trial of the safety and the immunogenicity of a combined dihtheria, tetanus, acellular pertussis and inactivated polio vaccine (DTacP-IPV) mixed with Haemophilus influenzae type b vaccine (Act-HIB®) given either at 3-5 and 12 or 2-4-6 and 13 months of age |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 41190 |
Study title: Safety and dose-escalation of a tetravalent Meningococcal polysaccharide diphtheria conjugate (A, C, Y AND W-135) vaccine adults, toodlers and infants |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 41204 |
Study title: Safety and dose-escalation of a tetravalent meningococcal polysaccharide diphtheria conjugate (A, C, Y and W-135) vaccine in adults, toddlers and infants |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 47470 |
Study title: Safety and immunogenicity of a diphteria, tetanus, acellular pertussis, enhanced inactivated trivalent poliovirus vaccine administered separately or combined with Haemophilus influenzae type b vaccine, to healthy Chilean infants |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 41188 |
Study title: Clinical evaluation of hydroxyzine hydrochloride in pediatric anesthesia and its effect on arousal time. |
Active substance: HYDROXYZINE |
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Document reference: 29304 |
Study title: Clinical evaluation of parenteral hydroxyzine for preoperative medication |
Active substance: HYDROXYZINE |
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Document reference: 29265 |
Study title: Clinical observation to evaluate the patient oriented dosages of Palladon® retard with respect to circadian variations in pain intensity (0.1% of patients 10-19 years) (Germany) |
Active substance: HYDROXYZINE |
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Document reference: 29374 |
Study title: Clinical observation utilizing morphine sulfate and hydroxyzine pamoate for sedating apprehensive children for dental procedures: a nine-year report. |
Active substance: HYDROXYZINE |
Study summary document link (including results): ADPE91B2604.pdf |
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Document reference: 29329 |
Study title: Azzara A, Meozzi A, Carulli G, Margelli A, Tangheroni F, Serravalle E, Ambrogi F. Presented at Session 18: Italian Society of Chemotherapy, 13th National Congress; June 9-11, 1983; Catania, Italy; 2(3):399-400. Normalization of neutrophilic functions in children suffering from recurrent chronic infections after cyclic therapy with methisoprinol.Azzara A, Meozzi A, Carulli G, Margelli A, Tangheroni F, Serravalle E, Ambrogi F. Presented at Session 18: Italian Society of Chemotherapy, 13th National Congress; June 9-11, 1983; Catania, Italy; 2(3):399-400. Normalization of neutrophilic functions in children suffering from recurrent chronic infections after cyclic therapy with methisoprinol. |
Active substance: INOSINE |
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Document reference: 30075 |
Study title: Le chlorhydrate d’hydroxyzine comme medicament adjuvant dans l’anesthesie generale. |
Active substance: HYDROXYZINE |
Study summary document link (including results): ADPI92D0131.pdf |
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Document reference: 29318 |
Study title: Mast cell quantification in the skin of children with atopic dermatitis : its value in diagnosis and in assessing the effctiveness of therapy |
Active substance: HYDROXYZINE |
Study summary document link (including results): ADPE97H2007.pdf |
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Document reference: 29268 |
Study title: Indomethacin in urticaria and histamine induced wealing. A double-blind evaluation. |
Active substance: INDOMETHACIN |
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Document reference: 29932 |
Study title: Endocrine disorders in newborn - Bongiovanni AM et al - 1981 - In Avery GB (Ed): Neonatalogy: Pathophysiology and Management of the Newborn, 2nd Ed. JB Lippincott, Philadelphia, 1981; pp 1104-1127) - Publication in the Comprehensive Summary of Hydrocortison in dated 27/06/1995 - |
Active substance: HYDROCORTIZONE |
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Document reference: 29162 |
Study title: Fluoride varnish for community based caries prevention in children1997-peterson |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1997-peterson-Fluoride varnish for community based caries prevention in children.pdf |
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Document reference: 49124 |
Study title: Fluoride varnish versus acidulated phosphate fluoride gel1995-seppa |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1995-seppa-Fluoride varnish versus acidulated phosphate fluoride gel.pdf |
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Document reference: 49120 |
Study title: Fluoride varnishes in caries prevention. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42420 |
Study title: Clinical observations on the use of hydroxyzine in anxiety- tension states and senile agitation. |
Active substance: HYDROXYZINE |
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Document reference: 29334 |
Study title: Comparative evaluation of combined preoperative medications for pediatric surgery. |
Active substance: HYDROXYZINE |
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Document reference: 29278 |
Study title: A phase IV comparative study evaluating the onset of analgesia using a single dose of ibuprofen chewable tablets 400 mg, ibuprofen suspension 400 mg/20 ml or placebo in post-operative dental painA phase IV comparative study evaluating the onset of analgesia using a single dose of ibuprofen chewable tablets 400 mg, ibuprofen suspension 400 mg/20 ml or placebo in post-operative dental pain |
Active substance: IBUPROFEN AND PSEUDOEPHEDRINE |
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Document reference: 29683 |
Study title: A pilot comparative study evaluating the analgesic effect of using a single dose of an ibuprofen 200 mg / acetaminophen 650 mg combination or ibuprofen 400 mg in post-operative dental pain A pilot comparative study evaluating the analgesic effect of using a single dose of an ibuprofen 200 mg / acetaminophen 650 mg combination or ibuprofen 400 mg in post-operative dental pain |
Active substance: IBUPROFEN AND PSEUDOEPHEDRINE |
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Document reference: 29663 |
Study title: Narcotic sedation: an evaluation of cardiopulmonary para- meters and behavior modification in pediatric dental patients. |
Active substance: HYDROXYZINE |
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Document reference: 29242 |
Study title: Preliminary survey of results obtained in infantile psychiatrics with a derivative of chlorobenzhydryl. |
Active substance: HYDROXYZINE |
Study summary document link (including results): ADPE92B2101-translation.pdf |
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Document reference: 29271 |
Study title: Xiao Z. An open label multi-center clinical trial to evaluate the efficacy of compound pseudoephedrine (corrected) hydrochloride sustained release capsules in patients with nasal symptoms associated with common cold. Chinese journal of internal medicine 2002; 41(8):547-9Xiao Z. An open label multi-center clinical trial to evaluate the efficacy of compound pseudoephedrine (corrected) hydrochloride sustained release capsules in patients with nasal symptoms associated with common cold. Chinese journal of internal medicine 2002; 41(8):547-9 |
Active substance: IBUPROFEN AND PSEUDOEPHEDRINE |
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Document reference: 29750 |
Study title: Observational study Jutussin N R9 |
Active substance: (HMP) Belladonna D4, Bryonia D3, Coccus cacti D6, Corallium rubrum D12, Cuprum aceticum D12, Drosera D4, Ipecacuanha D6, Spongia D6, Sticta D4 |
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Document reference: 39732 |
Study title: Observational study Cysto-Gastreu R18 |
Active substance: (HMP) Berberis vulgaris D4, Cantharis D4, Dulcamara D4, Equisetum hiemale D6, Eupatorium purpureum D6 |
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Document reference: 39733 |
Study title: Observational study Hypotonie-Gastreu R44 |
Active substance: (HMP) Crataegus D1, Laurocerasus D3, Oleander D3, Spartium scoparium D2 |
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Document reference: 39734 |
Study title: Efficacy of Tonsilotren in the treatment of acute angina catarrhalis. |
Active substance: (Homeopathic) Per tablet: Atropinum sulfuricum D5 12,5 mg Hepar sulfuris D3 10,0 mg Kalium bichromicum D4 50,0 mg Silicea D2 5,0 mg Mercurius bijodatus D8 25,0 mg |
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Document reference: 39745 |
Study title: A study to determine the safety of IMMUNO's virus-inactivated plasma derivatives in patients naive to blodd product administration Efficacy and Safety of Immunine in Continuous Infusion in patients with hemophilia B undergoing surgery Single Patient use of Factor IX Concentrates |
Active substance: HUMAN COAGULATION FACTOR IX |
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Document reference: 29127 |
Study title: Evaluation of Immunogenicity, Tolerability and Viral Safety in Haemophilia B Patients under Therapy with OCTANINE F |
Active substance: HUMAN COAGULATION FACTOR IX |
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Document reference: 29130 |
Study title: A double-blind, single dose evaluation of the comparative analgesic efficacy of acetaminophen 1000 mg, ibuprofen 400 mg, ibuprofen 200 mg, and placebo in the treatment of pain following oral surgery |
Active substance: IBUPROFEN |
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Document reference: 29488 |
Study title: A double-blind, single dose evaluation of the comparative analgesic efficacy of aspirin 800 mg plus caffeine 64 mg, ibuprofen 400 mg and placebo in the treatment of post-operative pain following third molar extraction |
Active substance: IBUPROFEN |
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Document reference: 29500 |
Study title: A double-blind, single dose evaluation of the comparative efficacy of acetaminophen 1000 mg, ibuprofen 200 mg, ibuprofen 400 mg, and placebo in the treatment of pain following periodontal surgery |
Active substance: IBUPROFEN |
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Document reference: 29486 |
Study title: A double-blind, single dose evaluation of the comparative efficacy of acetaminophen 1000 mg, ibuprofen 200 mg, ibuprofen 400 mg, and placebo in the treatment of pain following periodontal surgery. Stat Rpt 66. Protocol 3-279, Unpublished Report 185. |
Active substance: IBUPROFEN AND PARACETAMOL |
Study summary document link (including results): ibuprofen_paracetamol 3-279.pdf |
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Document reference: 47390 |
Study title: A Pilot Comparative Study Evaluating the Analgesic Effect of Using a Single Dose of an Ibuprofen 200 mg / Acetaminophen 650 mg Combination or Ibuprofen 400 mg in Post-Operative Dental Pain. |
Active substance: IBUPROFEN AND PARACETAMOL |
Study summary document link (including results): ibuprofen_paracetamol 98-053.pdf |
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Document reference: 47413 |
Study title: Safety and immunogenicity of Imovax Polio vaccine in Korean infants, when given at 2,4 and 6 months of age |
Active substance: Inactivated Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 47471 |
Study title: A clinical trial of indomethacin and ibuprofen in dysmenorrhea.Evaluation of prophylactic passive immunization using IGIV to prevent late onset neonatal infection among low birth weight(< 1750 grams) neonates. Baxter Internal ReportBB IND 1628: June, 1992 |
Active substance: INDOMETHACIN |
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Document reference: 29791 |
Study title: A comparative evaluation of indomethacin, acetaminophen and placebo as antipyretic agents in children. |
Active substance: INDOMETHACIN |
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Document reference: 29794 |
Study title: Double-blind evaluation of intravenous indomethacin and oxycone-papaverine in the treatment of acute biliary pain. |
Active substance: INDOMETHACIN |
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Document reference: 29864 |
Study title: safety and immunogenicity of immovax polio vaccine in Korean infants, whn given at 2, 4 and 6 months of age |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 41182 |
Study title: Safety and immunogenicity of PMSV diphtheria, tetanus, acellular pertussis, polio (DTacP-IPV) vaccine given mixed or separately with Haemophilus influenzae type b (Act-HIB®) vaccine, as a primary series. Comparison of three lots of DTacP-IPV vaccine given combined or separately with Act-HIB® |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 41189 |
Study title: Safety and immunogenicity of two inactivated poliovirus vaccines in combination with an acellular pertussis vaccine and diphtheria and tetanus toxoids in seventeen-to nineteen-month-old infants |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 41192 |
Study title: Safety and immunogenicity of Vi CPS vaccine in teenagers |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 21209 |
Study title: Safety of IPV of one or two doses in chinese infants |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 41183 |
Study title: Study of the booster effect of IPV vaccination on children |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 41196 |
Study title: The immune response after two doses of a new killed poliomyelitis vaccine |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 41202 |
Study title: Trial on the persistence of antibodies 4 years after a first booster with PENTAVAC® vaccine and the immunogenicity and safety of a second booster with TETRAVAC ACELLULAIRE® vaccine at the age of 5-6 years |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 41195 |
Study title: Open label study to evaluate the safety and immunogenicity of a hepatitis A vaccine (Avaxim 160U) |
Active substance: Inactivated Hepatitis A vaccine adsorbed for adults (160 U) |
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Document reference: 47625 |
Study title: OPEN STUDY OF IMMUNOGENICITY AND SAFETY OF THE P.M.sv. (160 U) HEPATlTlS A VACCINE ON CHILDREN AND ADULTS |
Active substance: Inactivated Hepatitis A vaccine adsorbed for adults (160 U) |
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Document reference: 47624 |
Study title: Open study of immunogenicity and safety of the P.M.sv. Hepatitis A vaccine (160 antigen units) in children |
Active substance: Inactivated Hepatitis A vaccine adsorbed for adults (160 U) |
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Document reference: 47623 |
Study title: |
Active substance: Inactivated hepatitis A virus |
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Document reference: 41107 |
Study title: |
Active substance: Inactivated hepatitis A virus |
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Document reference: 41108 |
Study title: |
Active substance: Inactivated hepatitis A virus |
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Document reference: 41110 |
Study title: |
Active substance: Inactivated hepatitis A virus |
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Document reference: 41113 |
Study title: |
Active substance: Inactivated hepatitis A virus |
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Document reference: 41114 |
Study title: Tocolysis in advanced preterm labor: impact on neonatal outcome. |
Active substance: INDOMETHACIN |
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Document reference: 30044 |
Study title: Treatment of renal colic by prostaglandin synthetase inhibitors and avafortan (analgesic antispasmodic). |
Active substance: INDOMETHACIN |
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Document reference: 30049 |
Study title: Treatment of renal colic by prostaglandin synthetase inhibitors and avafortan (analgesic antispasmodic). |
Active substance: INDOMETHACIN |
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Document reference: 30050 |
Study title: Cornaglia-Farraris P, Pasino M, Maggio A, Barabino A, Perlino GF, Massimo L. In: Le immunodeficienze primitive in Italia. Rome, Italy: Acta Medica, Field Educational Italia SpA; 1982. Chapter 4. Therapeutic success with methisoprinol in a case of congenital immune deficiency: clinical and immunological observations after one year of clinical therapy.Cornaglia-Farraris P, Pasino M, Maggio A, Barabino A, Perlino GF, Massimo L. In: Le immunodeficienze primitive in Italia. Rome, Italy: Acta Medica, Field Educational Italia SpA; 1982. Chapter 4. Therapeutic success with methisoprinol in a case of congenital immune deficiency: clinical and immunological observations after one year of clinical therapy. |
Active substance: INOSINE |
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Document reference: 30092 |
Study title: Effectiveness and Safety of the Angiotensin II Antagonist Irbesartan in Children With Chronic Kidney Diseases |
Active substance: irbesartan |
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Document reference: 41533 |
Study title: Experience with Irbesartan Use in Children 16 Years of Age and Younger: A Descriptive Study in Two Medical Claims Databases |
Active substance: irbesartan |
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Document reference: 45089 |
Study title: Effects of pH-neutral, bicarbonate-buffered dialysis fluid on peritoneal transport kinetics in children, 2002 Reduced Advanced Glycation Endproduct (AGE) Levels in Children on Automated Peritoneal Dialysis (PD) with PD-Fluids Containing Less Glucose Degradation Products (GDPs), 2003 |
Active substance: ISOTONIC SOLUTIONS |
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Document reference: 30758 |
Study title: A double-blind, placebo-controlled trial to evaluate the efficacy and safety of topically applied 0.1% isotretinoin cream for the treatment of acne vulgaris. |
Active substance: ISOTRETINOIN |
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Document reference: 30761 |
Study title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Cholesterol-Lowering Efficacy and Safety of Simvastatin as an Adjunct to Diet in Children and Adolescents With Familial Hypercholesterolemia |
Active substance: SIMVASTATIN |
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Document reference: 42224 |
Study title: Duraphat varnish a 2 year clinical trial in 5 year old childeren1977-murray, Brit. Dental J |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1977-murray-Duraphat varnish a 2 year clinical trial in 5 year old childeren.pdf |
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Document reference: 49103 |
Study title: Effect of fluoride varnish (Duraphat) treatment every 6 months compared with weekly mouthrinsing with 02 percent NaF solution on dental caries1979-koch |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1979-koch-Effect of fluoride varnish (Duraphat) treatment every 6 months compared with weekly mouthrinsing with 02 percent NaF solution on dental c... |
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Document reference: 49105 |
Study title: |
Active substance: Inactivated hepatitis A virus |
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Document reference: 41117 |
Study title: Long-term variability of heart rate increases with successful closure of patent ductus arteriosus in preterm infants. |
Active substance: INDOMETHACIN |
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Document reference: 29964 |
Study title: A single-centre, randomised, double-blind, cross-over trial comparing the within-subject variability of the pharmacokinetic profiles of insulin detemir and insulin glargine in children and adolescents with type 1 diabetes, LPLV October 2005 |
Active substance: insulin detemir |
Study summary document link (including results): NN304-1633-synopsis.pdf |
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Document reference: 41577 |
Study title: Effectiveness of preoperative transarterial chemoembolization in presumed inoperable hepatoblastoma. Han-Y-M. Journal of Vascular and Interventional Radiology, 1999, Vol/Iss/Pg. 10/9 (1275-1280)Effectiveness of preoperative transarterial chemoembolization in presumed inoperable hepatoblastoma. Han-Y-M. Journal of Vascular and Interventional Radiology, 1999, Vol/Iss/Pg. 10/9 (1275-1280) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30236 |
Study title: Embolization and intra-vascular therapy in thoracic, abdominal and peripheral pediatric diseases. ; Brunelle-F. Annales de Pediatrie, 1983, Vol/Iss/Pg. 30/3 (189-193)Embolization and intra-vascular therapy in thoracic, abdominal and peripheral pediatric diseases. ; Brunelle-F. Annales de Pediatrie, 1983, Vol/Iss/Pg. 30/3 (189-193) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30240 |
Study title: Emergency endovascular embolization of traumatic intrarenal arterial pseudoaneurysms with N-Butyl cyanoacrylate. 02/12/2010Emergency endovascular embolization of traumatic intrarenal arterial pseudoaneurysms with N-Butyl cyanoacrylate. 02/12/2010 |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30243 |
Study title: Multidetector CT in evaluating blood supply of hepatocellular carcinoma after transcatheter arterial chemoembolization. ; Guan-Y-S. World Journal of Gastroenterology, 15 JUL 2004, Vol/Iss/Pg. 10/14 (2127-2129)Multidetector CT in evaluating blood supply of hepatocellular carcinoma after transcatheter arterial chemoembolization. ; Guan-Y-S. World Journal of Gastroenterology, 15 JUL 2004, Vol/Iss/Pg. 10/14 (2127-2129) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30291 |
Study title: Pediatric thoraco-lumbar paraspinal arteriovenous fistulas along the segmental nerve: Diagnosis and endovascular treatment. ; Niimi-Y. Interventional Neuroradiology, 2006, Vol/Iss /Pg. 12/SUPPL. 1 (158-162)Pediatric thoraco-lumbar paraspinal arteriovenous fistulas along the segmental nerve: Diagnosis and endovascular treatment. ; Niimi-Y. Interventional Neuroradiology, 2006, Vol/Iss /Pg. 12/SUPPL. 1 (158-162) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30296 |
Study title: The rationale for the administration of a NaF tablet supplement during pregnancy and postnatally in a private practice setting.Frances B. Glenn 1981, Journal of Dentistry for Children |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1981-Glenn-The Rationale for the Administration od a NaF Tablet Supple,ment during Pregnancy and Postnatally in a private practice setting.pdf |
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Document reference: 48778 |
Study title: Variation in caries prevalence related to combinations of dietary andoral hygiene habits and chewing fluoride tablets in 4 year old childrenLars-Eric Granath, Holger Rootzen, Elso Liljegren, Kerstin Hoist, Lennart Kohler 1978. Caries Res 12: 83-92 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1978-granath-Caries prevalence related to combinations of dietary and oral hygiene habits and chewing fluoride tablets in 4 years old children.pdf |
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Document reference: 48781 |
Study title: Evaluation of the accuracy of steady-state krypton-81m method for calculating right ventricular ejection fraction.Ham HR 1986, J Nucl Med. 1986 May;27(5):593-601. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): Ham 1986.pdf |
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Document reference: 48787 |
Study title: Evaluation of the effects of nasal septal deviation and its surgery on nasal mucociliary clearance in both nasal cavities.Am J Rhinol. 2007 Mar-Apr;21(2):180-3. Ulusoy B 2007 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48790 |
Study title: Evaluation of the ventilation-perfusion ratio in lung diseases by simultaneous anterior and posterior image acquisition. Ann Nucl Med. 1994 Nov;8(4):269-76. Nakata Y 1994 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48818 |
Study title: Extravasation from venous catheter: a serious complication potentially missed by lung imaging.Spicer KM 1983 J Nucl Med. 1983Nov;24(11):1023-6. |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): Spicer 1983.pdf |
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Document reference: 48788 |
Study title: Hepatopulmonary syndrome in Gaucher disease with right-to-left shunt: evaluation and measurement using Tc-99m MAA. Clin Nucl Med. 1999 Mar;24(3):164-6. Kim JH 1999 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48809 |
Study title: Bone scanning in the adductor insertion avulsion syndrome ("thigh splints"). Charkes ND, Siddhivarn N, Schneck CD. J Nucl Med. 1987 Dec;28(12):1835-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48839 |
Study title: Experimental use of macrodex as a prophylaxis against post-operative thrombo-embolism.KOEKENBERG LJ. Bull Soc Int Chir. 1962 Sep-Oct;21:501-12. |
Active substance: Dextran |
Study summary document link (including results): |
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Document reference: 48938 |
Study title: Prevention of dextran-induced anaphylactic reactions by hapten inhibition. III. A Scandinavian multicenter study on the effects of 20 ml dextran 1, 15%, administered before dextran 70 or dextran 40.Renck H, Ljungström KG, Hedin H, Richter W. Acta Chir Scand. 1983;149(4):355-60. |
Active substance: Dextran |
Study summary document link (including results): |
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Document reference: 48941 |
Study title: Percutaneous sclerotherapy for lymphatic malformations: A retrospective analysis of patient-evaluated improvement. Alomari-A-I. Journal of Vascular and Interventional Radiology, 2006, Vol/Iss/Pg. 17/10 (1639-1648), 0443.Percutaneous sclerotherapy for lymphatic malformations: A retrospective analysis of patient-evaluated improvement. Alomari-A-I. Journal of Vascular and Interventional Radiology, 2006, Vol/Iss/Pg. 17/10 (1639-1648), 0443. |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30301 |
Study title: HEALTH ECONOMIC DRUG UTILIZATION OBSERVATION "XPENSE" FOR COMPARISON OF THE COSTS OF DIFFERENT MEDICAL GLAUCOMA THERAPIES |
Active substance: LATANOPROST/LATANOPROST AND TIMOLOL |
Study summary document link (including results): |
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Document reference: 31021 |
Study title: Björklund SI. Miniture enema in children’s practice. The Swedish Medical Journal 1961:58:2763-2766. Devaux j, Bernard JL, Mouly-Bandini a, Raybaud CI. Use of a peptisant gel in a pediatric ward. Méditerranée Médicale 1975:3:65-68 No.67 (English translation). Björklund SI. Miniture enema in children’s practice. The Swedish Medical Journal 1961:58:2763-2766. Devaux j, Bernard JL, Mouly-Bandini a, Raybaud CI. Use of a peptisant gel in a pediatric ward. Méditerranée Médicale 1975:3:65-68 No.67 (English translation). |
Active substance: LAURYL SULPHATE AND SORBITOL |
Study summary document link (including results): |
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Document reference: 31024 |
Study title: Safety of Picolax in inflammatory bowel disease.Evans M, Walker-Smith J, Williams Ch., 1989, BMJ 1989; 299: 1101 – 1102 |
Active substance: SODIUM PICOPSULPHATE |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48900 |
Study title: Three year report on caries prevention using I fluoride varnish for caries risk children in a community with fluoridated water1982-seppa |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1982-seppa-Three year report on caries prevention using I fluoride varnish for caries risk children in a community with fluoridated water.pdf |
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Document reference: 49109 |
Study title: Topical application of a fluoride protective varnish for caries prophylaxis1973-maiwald |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1973-maiwald-Topical application of a fluoride protective varnish for caries prophylaxis.pdf |
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Document reference: 49101 |
Study title: Gingival recession and wedge-shaped defects with regular use of an amine fluoride-containing gel applied with a toothbrushSchiffner 1995 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): Schiffner 1995 Gingival recession and wedge-shaped.pdf |
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Document reference: 49177 |
Study title: K.E.E.P.E.R. (KEPPRA(R) EPILEPSY EVALUATION OF PATIENT TIME TO RESPONSE). A PHASE IV, OPEN-LABEL, MULTI-CENTER, COMMUNITY-BASED TRIAL STUDYING THE SAFETY AND EFFICACY OF LEVETIRACETAM AS ADD-ON THERAPY IN ADULT PATIENTS WITH TREATMENT-RESISTANT, PARTIAL-ONSET EPILEPSY. |
Active substance: levetiracetam |
Study summary document link (including results): N01030 - Levetiracetam - RRCE02E1301.pdf |
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Document reference: 31147 |
Study title: Bone scintigraphy in the diagnosis and follow up of Perthes' disease.Cavailloles F, Bok B, Bensahel H. Eur J Nucl Med 1982;7(7):327-30. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48588 |
Study title: AN 05134405 Medline 20070101. TI (Use of cyproheptadine to obtain recovery of the weight curve after tonsillectomy. Clinico-statistical observations on 91 cases). TT Sull'impiego della ciproeptadina per l'ottenimento di una ripresa della curva ponderale dopo l'intervento di tonsillectomia. Osservazioni clinico-statistich su 91 casi. SO Minerva otorinolaringologica, {Minerva-Otorinolaringol}, Sep-Oct 1971, vol. 21, no. 5, p. 191-5, ISSN: 0026-4938. AU Fior-R. YR 1971.AN 05134405 Medline 20070101. TI (Use of cyproheptadine to obtain recovery of the weight curve after tonsillectomy. Clinico-statistical observations on 91 cases). TT Sull'impiego della ciproeptadina per l'ottenimento di una ripresa della curva ponderale dopo l'intervento di... |
Active substance: CYPROHEPTADINE |
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Document reference: 25204 |
Study title: No advantages in the addition of ifosfamide and VP-16 to the standard four-drug regimen in the maintenance phase of neoadjuvant chemotherapy of Ewing's sarcoma of bone: results of two sequential studies. |
Active substance: DACTINOMYCIN |
Study summary document link (including results): |
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Document reference: 25401 |
Study title: Rigacci L, Castagnoli A, Dini C, Carpaneto A, Matteini M, Alterini R. FDG-positron emission tomography in post treatment evaluation of residual mass in Hodgkin's lymphoma: long-term results. [rigacci-2005]Oncol Rep. 2005 Nov;14(5):1209-14. 18. Rigacci L 2005 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48692 |
Study title: Long term evaluation of a SnF2 gel for control of gingivitis and decalcification in adolescent orthodontic patients1994-boyd |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1994-boyd - long term evaluation of a SnF2 gel for control of gingivitis and decalcification in adolescent orthodontic patients.pdf |
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Document reference: 49157 |
Study title: Plasma fluoride concentration and urinary fluoride excretion in children following application of the fluoride containing varnish Duraphat1980-ekstrand, Caries Res, 14: 185-189 1980 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1980-ekstrand-Plasma fluoride concentration and urinary fluoride excretion in children following application of the fluoride containing varnish Dur... |
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Document reference: 49106 |
Study title: Bestic JM, Peterson JJ, Bancroft LW.. Review. Erratum in: Radiographics. 2010 Jan-Feb;30(1):301. Pediatric FDG PET/CT: Physiologic uptake, normal variants, and benign conditions [corrected]. [bestic-2009] Radiographics. 2009 Sep-Oct;29(5):1487-500. Bestic JM 2009 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48632 |
Study title: Brenner W, Friedrich RE, Gawad KA, Hagel C, von Deimling A, de Wit M, et al.. Epub 2006 Jan 11. Prognostic relevance of FDG PET in patients with neurofibromatosis type-1 and malignant peripheral nerve sheath tumours. [brenner-2006]Eur J Nucl Med Mol Imaging. 2006 Apr;33(4):428-32. Brenner W 2006 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48635 |
Study title: Endemic goiter in rural peru: Effect of iodized oil on prevalence and size of goiter and on thyroid iodine metabolism in known endemic goitres populations; E.A. Pretell. Pan American Health Organization: Chapter 34 :419-437Endemic goiter in rural peru: Effect of iodized oil on prevalence and size of goiter and on thyroid iodine metabolism in known endemic goitres populations; E.A. Pretell. Pan American Health Organization: Chapter 34 :419-437 |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30245 |
Study title: Endoscopic sclerotherapy of gastric variceal bleeding with N-butyl-2- cyanoacrylate. ; Dhiman-R-K. Journal of Clinical Gastroenterology, 2002, Vol /Iss/Pg. 35/3 (222-227)Endoscopic sclerotherapy of gastric variceal bleeding with N-butyl-2- cyanoacrylate. ; Dhiman-R-K. Journal of Clinical Gastroenterology, 2002, Vol /Iss/Pg. 35/3 (222-227) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30246 |
Study title: Successful left hepatectomy for hepatocellular carcinoma in a child after transcatheter arterial chemoembolization: Report of a survival. ; Uemura-S, T. European Journal of Pediatric Surgery, 1993, Vol /Iss/Pg. 3/1 (54-56)Successful left hepatectomy for hepatocellular carcinoma in a child after transcatheter arterial chemoembolization: Report of a survival. ; Uemura-S, T. European Journal of Pediatric Surgery, 1993, Vol /Iss/Pg. 3/1 (54-56) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30327 |
Study title: The effect of varying doses of oral iodized oil in the prophylaxis of endemic goitre in elementary schools children. ; Abuye-C. Ethiopian Medical Journal, 1995, Vol/Iss/Pg. 33/2 (115-123)The effect of varying doses of oral iodized oil in the prophylaxis of endemic goitre in elementary schools children. ; Abuye-C. Ethiopian Medical Journal, 1995, Vol/Iss/Pg. 33/2 (115-123) |
Active substance: IODINE |
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Document reference: 30331 |
Study title: Clinical trial to evaluate efficacy and tolerability of subcutaneously administered leuprorelin acetate as a 1-month depot in a weight-dependent dosage in female patients with central precocious puberty + Biometrical report- interim results on bone metabolism |
Active substance: LEUPRORELIN |
Study summary document link (including results): 2011-08-11 Leuprorelin EC08(128)_EC108 Synopsis.pdf |
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Document reference: 31043 |
Study title: Leuproreline acetate in the treatment of central precocious puberty: a 12-month, multicenter, randomised, equivalence trial of two different depot formulations |
Active substance: LEUPRORELIN |
Study summary document link (including results): Leuprorelin_LEUb_CPP3M14_Synopsis.pdf |
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Document reference: 31048 |
Study title: Leuproreline acetate in the treatment of central precocious puberty: a 12-month, multicenter, randomised, equivalence trial of two different depot formulations |
Active substance: LEUPRORELIN |
Study summary document link (including results): Leuprorelin_LEUb_CPP3M14_Synopsis.pdf |
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Document reference: 31045 |
Study title: Reduction in dental caries with four concentrations of sodium fluoride in a dentifrice: a meta-analysis evaluation2001-Bartizek, The journal of clinical dentistry |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 2001-Bartizek-reduction in dental caries with four concentrations of sodium fluoride in a dentifrice.pdf |
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Document reference: 49087 |
Study title: Results of the Sherbrooke-Lac Megtanic fluoride varnish study after 20 months1985-clark |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1985-clark-Results of the Sherbrooke-Lac Megtanic fluoride varnish study after 20 months.pdf |
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Document reference: 49112 |
Study title: Rovamycine (Spiramycine) RP5337 - Etude clinique nationale de la rovamycine sirop pediatrique |
Active substance: SPIRAMYCIN |
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Document reference: 42590 |
Study title: An open phase III follow-up (5 years) trial of recombinant human interferon gamma-1b in patients with chronic granulomatous disease (CGD) to evaluate safety and efficacy of long-term interferon gamma-1b treatment - 5-year-follow-up safety report. |
Active substance: INTERFERON GAMMA (1B) |
Study summary document link (including results): |
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Document reference: 30191 |
Study title: I0016g(A),CH 9903,137.41 - An open phase III follow-up (5 years) trial of recombinant human interferon gamma-1b in patients with chronic granulomatous disease (CGD) to evaluate safety and efficacy of long-term interferon gamma-1b treatment - 5-year-follow-up safety report. |
Active substance: INTERFERON GAMMA (1B) |
Study summary document link (including results): |
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Document reference: 30196 |
Study title: 3 D CT angiography for detection of vascular complications in pediatric liver transplantation; CHENG YF; C Liver Transplant.; 2004 vol.10 n.2 p.248 2523 D CT angiography for detection of vascular complications in pediatric liver transplantation; CHENG YF; C Liver Transplant.; 2004 vol.10 n.2 p.248 252 |
Active substance: IOVERSOL |
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Document reference: 30402 |
Study title: Appendicitis in children : low dose CT with a phantom based simulation technique initial observations; FEFFERMAN NR; Radiology; 2005 vol.237 p.641 646Appendicitis in children : low dose CT with a phantom based simulation technique initial observations; FEFFERMAN NR; Radiology; 2005 vol.237 p.641 646 |
Active substance: IOVERSOL |
Study summary document link (including results): |
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Document reference: 30396 |
Study title: Endovascular Therapy for Priapism Secondary to Perineal Trauma; Ayrton C. J Trauma. 2001;50:571-584Endovascular Therapy for Priapism Secondary to Perineal Trauma; Ayrton C. J Trauma. 2001;50:571-584 |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30247 |
Study title: Endovascular treatment in vein of Galen aneurysms. Case report. ;Battistella-P-A. Rivista di Neuroradiologia, 1994, Vol/Iss/Pg. 7/4 (671-681)Endovascular treatment in vein of Galen aneurysms. Case report. ;Battistella-P-A. Rivista di Neuroradiologia, 1994, Vol/Iss/Pg. 7/4 (671-681) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30248 |
Study title: Endovascular treatment of arteriovenous fistulas complicating percutaneous renal biopsy in three paediatric cases. ;Bilge-I. Nephrology Dialysis Transplantation, 1999, Vol/Iss/Pg. 14/11 (2726-2730)Endovascular treatment of arteriovenous fistulas complicating percutaneous renal biopsy in three paediatric cases. ;Bilge-I. Nephrology Dialysis Transplantation, 1999, Vol/Iss/Pg. 14/11 (2726-2730) |
Active substance: IODINE |
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Document reference: 30250 |
Study title: Endovascular treatment of spinal arteriovenous fistula in a young child with hereditary hemorrhagic telangiectasia. Case report. ;Stephan-M-J. Journal of Neurosurgery, 2005, Vol/Iss/Pg. 103 PEDIATRICS/SUPPL. 5 (462-465)Endovascular treatment of spinal arteriovenous fistula in a young child with hereditary hemorrhagic telangiectasia. Case report. ;Stephan-M-J. Journal of Neurosurgery, 2005, Vol/Iss/Pg. 103 PEDIATRICS/SUPPL. 5 (462-465) |
Active substance: IODINE |
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Document reference: 30251 |
Study title: Evaluation of the intra-hepatic arterial injection therapy of cisplatin (CDDP)-Lipiodol suspension in a child with hepatoblastoma. Ohtsubo-K. Journal of Japan Society for Cancer Therapy, 1990, Vol/Iss/Pg. 25/1 (31-39)Evaluation of the intra-hepatic arterial injection therapy of cisplatin (CDDP)-Lipiodol suspension in a child with hepatoblastoma. Ohtsubo-K. Journal of Japan Society for Cancer Therapy, 1990, Vol/Iss/Pg. 25/1 (31-39) |
Active substance: IODINE |
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Document reference: 30253 |
Study title: Hemobilia: Transcatheter Occlusive Therapy and Long-term Follow-up;Renan Uflacker. Cardiovasc Intervent Radiol (1989) 12:136-141Hemobilia: Transcatheter Occlusive Therapy and Long-term Follow-up;Renan Uflacker. Cardiovasc Intervent Radiol (1989) 12:136-141 |
Active substance: IODINE |
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Document reference: 30257 |
Study title: Hepatocellular carcinoma and portal vein invasion: Results of treatment with transcatheter oily chemoembolization. ;Jin-Wook-Chung, J. American Journal of Roentgenology, 1995, Vol/Iss/Pg. 165/2 (315-321)Hepatocellular carcinoma and portal vein invasion: Results of treatment with transcatheter oily chemoembolization. ;Jin-Wook-Chung, J. American Journal of Roentgenology, 1995, Vol/Iss/Pg. 165/2 (315-321) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30259 |
Study title: Ink J. Buenos Aires, Argentina: Teodoro Alvarez Hospital and Del Carmen Hospital. 1972. (Summary expert clinical report to Newport Pharmaceuticals International, Inc.) Isoprinosine® syrup against different acute viral diseasesInk J. Buenos Aires, Argentina: Teodoro Alvarez Hospital and Del Carmen Hospital. 1972. (Summary expert clinical report to Newport Pharmaceuticals International, Inc.) Isoprinosine® syrup against different acute viral diseases |
Active substance: INOSINE |
Study summary document link (including results): |
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Document reference: 30127 |
Study title: The use of iodized oil in goiter prevention.;John Kevany. American Journal of Public Health 1970 60 919-925The use of iodized oil in goiter prevention.;John Kevany. American Journal of Public Health 1970 60 919-925 |
Active substance: IODINE |
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Document reference: 30334 |
Study title: The value of embolization in the prognosis of renal cell carcinoma.; Basche-S. Annales de Radiologie, 1988, Vol/Iss/Pg. 31/6 (333-336) The value of embolization in the prognosis of renal cell carcinoma.; Basche-S. Annales de Radiologie, 1988, Vol/Iss/Pg. 31/6 (333-336) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30335 |
Study title: Therapeutic arterial embolization of tumors and vascular lesions in the maxillofacial region and skull base. ; Heuser-L. RoFo Fortschritte auf dem Gebiete der Rontgenstrahlen und der Neuen Bildgebenden Verfahren, 1990, Vol/Iss/Pg. 152/5 (544-549)Therapeutic arterial embolization of tumors and vascular lesions in the maxillofacial region and skull base. ; Heuser-L. RoFo Fortschritte auf dem Gebiete der Rontgenstrahlen und der Neuen Bildgebenden Verfahren, 1990, Vol/Iss/Pg. 152/5 (544-549) |
Active substance: IODINE |
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Document reference: 30336 |
Study title: Primary septic arthritis in heroin users: early diagnosis by radioisotopic imaging and geographic variations in the causative agentsLopez-Longo FJ. Menard HA. Carreno L. eosin J. Ballesteros R. Monteagudo I. J Rheumatol 1987 Oct;14(5):991-4 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48499 |
Study title: CT of small bowel ischemia associated with obstruction in emergency department patients ; diagnostic performance evaluation; SHEEDY SP; Radiology; 2006 vol.241 n.3 p.729 736CT of small bowel ischemia associated with obstruction in emergency department patients ; diagnostic performance evaluation; SHEEDY SP; Radiology; 2006 vol.241 n.3 p.729 736 |
Active substance: IOVERSOL |
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Document reference: 30408 |
Study title: Comparative evaluation of iohexol and inulin clearance for glomerular filtration rate determinations Acta paediatrica (1994), 83(4), 418-22 Lindblad HG 1994 |
Active substance: IOHEXOL |
Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc |
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Document reference: 48859 |
Study title: Double-blind randomized evaluation of clinical and biological tolerance of polyethylene glycol 4000 versus lactulose in constipated children. Dupont C, Leluyer B, Maamri N, Morali A, Joye JP, Fiorini JM, Abdelatif A, Baranes C, Benoît S, Benssoussan A, Boussioux JL, Boyer P, Brunet E, Delorme J, François-Cecchin S, Gottrand F, Grassart M, Hadji S, Kalidjian A, Languepin J, Leissler C, Lejay D, Livon D, Lopez JP, Mougenot JF, Risse JC, Rizk C, Roumaneix D, Schirrer J, Thoron B, Kalach N. J Pediatr Gastroenterol Nutr. 2005 Nov;41(5):625-33.Double-blind randomized evaluation of clinical and biological tolerance of polyethylene glycol 4000 versus lactulose in constipated children. Dupont C, Leluyer B, Maamri N, Morali A, Joye JP, Fiorini JM, Abdelatif A, Baranes C, Benoît S, Benssoussan A, ... |
Active substance: LACTULOSE |
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Document reference: 30996 |
Study title: Fluorides in community programms-A study of four years of various fluorides applied topically to the teeth of children in fluoridated communities1972-Swejda |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1972-Swejda-Fluorides in community programms-A study of four years of various fluorides applied topically to the teeth of children in fluoridated c... |
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Document reference: 49150 |
Study title: Effectiveness of visible light fissure sealant (Delton) versus fluoride varnish (Duraphat) 24 month clinical trial1996-bravo, Community Dent. Oral Epidemiol. 1996: 24: 42-6 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1995-seppa-Fluoride varnish versus acidulated phosphate fluoride gel.pdf |
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Document reference: 49121 |
Study title: Normal anatomic variant: scintigraphy of the ischiopubic synchondrosis. Kevin A. Cawley, Allen D. Dvorak, and Michael D. Wilmot J NucÃMed 24: 14-16,1983 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48838 |
Study title: Normal anatomic variant: scintigraphy of the ischiopubic synchondrosis.Cawley KA, Dvorak AD, Wilmot MD. J Nucl Med 1983 Jan;24(1):14-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48589 |
Study title: Radionuclide imaging in bilateral os trigonum syndrome in a young athlete. Minoves M, Company A, Ardevol J, Matas RB, Costansa JM, Setoain J, Domenech-Torné FM. Clin Nucl Med. 2001 Mar;26(3):237-8. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43458 |
Study title: Radionuclide imaging in the evaluation of osteomyelitis and septic arthritis.Kim EE, Haynie TP, Lowry PA, Harle TS. Crit Rev Diagn Imaging 1989; 29(3):257-305 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48751 |
Study title: Excretory urography with iohexol: evaluation in children Radiology (1986), 161(3), 625-30 Magill HL 1986 |
Active substance: IOHEXOL |
Study summary document link (including results): 2011-09 GE Omnipaque response List of published articles.doc |
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Document reference: 48860 |
Study title: Open, non-comparative study in angiocardiography in children, Angiocardiography: evaluate safety, tolerance and the radiographic properties of of iohexol in pediatric use. Systolic blood pressure, ECG parameters, body temperature, visualization and adverse reactions were recorded.Applicant's study report |
Active substance: IOHEXOL |
Study summary document link (including results): Copy of List of studies Omnipaque- pediatric.xls |
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Document reference: 48882 |
Study title: Clinical Performance of PET/CT in Evaluation of Cancer: Additional Value for Diagnostic Imaging and Patient ManagementRachel Bar-Shalom, MD1; Nikolai Yefremov, MD1; Ludmila Guralnik, MD2; Diana Gaitini, MD2,3; Alex Frenkel, DSc1; Abraham Kuten, MD3,4; Hernan Altman, MBA5; Zohar Keidar, MD, PhD1; and Ora Israel, MD1,3. THE JOURNAL OF NUCLEAR MEDICINE • Vol. 44 • No. 8 • August 2003 |
Active substance: Steripet |
Study summary document link (including results): bar-shalom-2003.pdf |
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Document reference: 48623 |
Study title: Comparison of 18F-FDG and 11C-Methionine for PET-Guided Stereotactic Brain Biopsy of GliomasJ Nucl Med 2004; 45:1293–1298. Benoit Pirotte, MD1; Serge Goldman, MD, PhD2; Nicolas Massager, MD1; Philippe David, MD3; David Wikler, MS1; Arlette Vandesteene, MD, PhD4; Isabelle Salmon, MD, PhD5; Jacques Brotchi, MD, PhD1; and Marc Levivier, MD, PhD1 |
Active substance: Steripet |
Study summary document link (including results): pirotte-2004.pdf |
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Document reference: 48742 |
Study title: De González AB, Mahesh M, Kim K-P, Bhargavan M, Lewis R, Mettler F, Land C. Arch Projected cancer risks from computed tomographic scans performed in the United States in 2007. [de-gonzalez-2009]Intern Med 2009; 169 : 2071 - 2077. De González AB 2009 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48639 |
Study title: Dietlein M, Krug B, Groth W, Smolarz K, Scheidhauer K, Psaras T, et al.. Positron emission tomography using 18Ffluorodeoxyglucose in advanced stages of malignant melanoma: a comparison of ultrasonographic and radiological methods of diagnosis. [dietlein-1999]Nucl Med Commun. 1999 Mar;20(3):255-61. Dietlein M 1999 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48640 |
Study title: Dobbeleir A, Ham H, Goethals I, Keppens J, D'Asseler Y, Van de Wiele C.. F-18 FDG-PET in children: do we have enough counts? [dobbeleir-2010]Nucl Med Commun. 2010 Mar;31(3):190-4. Dobbeleir A 2010 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48642 |
Study title: Effect of Whole-Body 18F-FDG PET Imaging on Clinical Staging and Management of Patients with Malignant LymphomaJ Nucl Med 2001; 42:1139–1143. Heiko Scho¨der, Joubin Meta, Cecilia Yap, Maryam Ariannejad, Jyotsna Rao, Michael E. Phelps, Peter E. Valk, Jim Sayre, and Johannes Czernin |
Active substance: Steripet |
Study summary document link (including results): schoder-2001.pdf |
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Document reference: 48745 |
Study title: A study to compare the efficacy and safety of 0.0625% Levobupivacaine, 1 IJg.mr1 fentanyl, 0.0625% levobupivacaine plus1 IJg.mr1 fentanyl and 0.125% Levobupivacaine when administered as an extradural infusion in paediatric patients undergoing elective abdominal or urological surgery |
Active substance: LEVOBUVICAINE HCL |
Study summary document link (including results): Levobupivacaine-30716.pdf |
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Document reference: 47651 |
Study title: Clin Nucl Med. 1999 Jun;24(6):435-9. Tc-99m DTPA used as reference imaging to evaluate the distribution of other tumor-seeking tracers in tumors associated with neurofibromatosis. Suga K, Hirabayashi A, Kishimoto K, Kume N, Matsumoto T, Matsunaga N. Clin Nucl Med. 1999 Jun;24(6):435-9. Tc-99m DTPA used as reference imaging to evaluate the distribution of other tumor-seeking tracers in tumors associated with neurofibromatosis. Suga K, Hirabayashi A, Kishimoto K, Kume N, Matsumoto T, Matsunaga N. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44556 |
Study title: Technetium 99m-methylene diphosphonate bone scans in children with reflex neurovascular dystrophy.Laxer RM. Allen RC. Malleson PN. Morrison RT. Petty RE. J Pediatr 1985Mar;106(3):437-40 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48496 |
Study title: Thallium-201 scintigraphy in childhood osteosarcoma: Comparison with Technituim-99m MDP and magnetic resonance imaging in the evaluation of chemotherapeutic response.Ilhan IE, Gulin V, Berberoglu S, Kapucuoglu N, Cila A, Eke S. Quantitative Hematol Oncol 2005;22(2):153-62 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48725 |
Study title: [The diagnostic importance of a quantitative evaluation of gamma scintigraphy in Perthes' disease in children]. Russian. Dmitrienkov BN, Fedin AV, Zhvaniia TG, Subbotina EN. Med Radiol (Mosk). 1989 Jul;34(7):19-23. Russian. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43784 |
Study title: The role of ultrasound and isotope scanning in the management of irritable hipsGopakumar TS. Vaishya R. Klenerman L. Carty H. Eur J Radiol 1992 Sep;15(2):113-7 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48484 |
Study title: Open, non-comparative study in the GI tract in children and infants to evaluate the suitability/tolerability of iohexol in the GI tract in infants/children by monitoring patient reactions, taste acceptance and visualization.Applicant's study report |
Active substance: IOHEXOL |
Study summary document link (including results): Copy of List of studies Omnipaque- pediatric.xls |
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Document reference: 48885 |
Study title: Open, non-comparative study Myelography study: evaluate safety, tolerance and image quality of iohexol in pediatric use.Applicant's study report |
Active substance: IOHEXOL |
Study summary document link (including results): Copy of List of studies Omnipaque- pediatric.xls |
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Document reference: 48884 |
Study title: Open, non-comparative study to evaluate the suitability/tolerability of iohexol in abdominal CT in infants/children by monitoring patient reactions, taste acceptance and image qualityApplicant's study report |
Active substance: IOHEXOL |
Study summary document link (including results): Copy of List of studies Omnipaque- pediatric.xls |
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Document reference: 48886 |
Study title: Franzius C, Schulte M, Hillmann A, Winkelmann W, Jürgens H, Bockisch A, et al.. [Clinical value of positron emission tomography (PET) in the diagnosis of bone and soft tissue tumors. 3rd Interdisciplinary Consensus Conference "PET in Oncology": results of the Bone and Soft Tissue Study Group] [Article in German] [franzius-2001]Chirurg. 2001 Sep;72(9):1071-7. Franzius C 2001 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48647 |
Study title: RM2002/00111/00 An open label long term observational study of the safety and tolerability of sumatriptan nasal spray in the treatment of migraine in adolescents. |
Active substance: SUMATRIPTAN |
Study summary document link (including results): Sumatriptan-SUM40276-ICHE3.pdf |
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Document reference: 43075 |
Study title: Gaillard WD, Bhatia S, Bookheimer SY, Fazilat S, Sato S, Theodore WH.. FDG-PET and volumetric MRI in the evaluation of patients with partial epilepsy. [gaillard-1995]Neurology. 1995 Jan;45(1):123-6. Gaillard WD 1995 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48653 |
Study title: A 48-month survival analysis comparing sealant (Delton) with fluoride varnish (Duraphat) in 6-8 year old children1997-bravo |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1996-bravo-Effectiveness of visible light fissure sealant (Delton) versus fluoride varnish (Duraphat) 24 month clinical trial.pdf |
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Document reference: 49122 |
Study title: Scintigraphic evaluation of calcinosis in juvenile dermatomyositis with Tc-99m MDP.Bar-Sever Z, Mukamel M, Harel L, Hardoff R. Clin Nucl Med 2000 Dec;25(12):1013-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48565 |
Study title: Scintimetric evaluation of posttraumatic and postoperative growth disturbance using 99Tcm MDP.Bylander B, Hansson LI, Kärrholm J, Naversten Y. Acta Radiol Diagn 1983;24(1):85-96. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48587 |
Study title: Use of 99m-Tc-MDP Spect for assessment of mandibular growth: development of normal values.Fahey FH, Abramson ZR, Padwa BL, Zimmerman RE, Zurakowski D, Nissenbaum M, et al. Eur J Nucl Med Mol Imaging 2010;37:1002-10. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48722 |
Study title: Detection of coronary complications after the arterial switch operation for transposition of the great arteries : first experience with multislice computed tomography in children; Ou P et al; Thorac.Cardiovasc. Surg.; 2006 vol.131 p.639 643Detection of coronary complications after the arterial switch operation for transposition of the great arteries : first experience with multislice computed tomography in children; Ou P et al; Thorac.Cardiovasc. Surg.; 2006 vol.131 p.639 643 |
Active substance: IOBITRITOL |
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Document reference: 30211 |
Study title: Intravenous contrast media in uroradiology : evaluation of safety and tolerability in almost 50,000 patients; Wendt M. et al; Med. Princ. Pract.; 2006 vol.15 p.358 361Intravenous contrast media in uroradiology : evaluation of safety and tolerability in almost 50,000 patients; Wendt M. et al; Med. Princ. Pract.; 2006 vol.15 p.358 361 |
Active substance: IOBITRITOL |
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Document reference: 30210 |
Study title: Evaluation de l'efficacite diagnostique et de la tolerance clinique du ioversol en tomodensitometrie "corps entier" chez l'enfant : essai non comparatif de phase III; PANUEL M; Ann. Radiol.; 1992 vol.35 n.4 bis p.280-283Evaluation de l'efficacite diagnostique et de la tolerance clinique du ioversol en tomodensitometrie "corps entier" chez l'enfant : essai non comparatif de phase III; PANUEL M; Ann. Radiol.; 1992 vol.35 n.4 bis p.280-283 |
Active substance: IOVERSOL |
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Document reference: 30409 |
Study title: Evaluation of the post-shunt status with electron beam computed tomography in cyanotic congenital heart disease; CHOI BW; Yonsei Med. J.; 2003 vol.44 n.2 p.249 258Evaluation of the post-shunt status with electron beam computed tomography in cyanotic congenital heart disease; CHOI BW; Yonsei Med. J.; 2003 vol.44 n.2 p.249 258 |
Active substance: IOVERSOL |
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Document reference: 30410 |
Study title: Hypothyroidism in an area of endemic goiter and cretinism in Central Java, Indonesia;G. Hennemann. J. Clin. Endocrinology metabolism 1997 44 3 481-490Hypothyroidism in an area of endemic goiter and cretinism in Central Java, Indonesia;G. Hennemann. J. Clin. Endocrinology metabolism 1997 44 3 481-490 |
Active substance: IODINE |
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Document reference: 30262 |
Study title: Hypothyroidism in cretins and non-cretinous subjects in an area of severe iodine deficiency in Central Java;Robbins J. et Coll. Thyroid research. Amsterdam excerpta medica 1975 378: 501-504Hypothyroidism in cretins and non-cretinous subjects in an area of severe iodine deficiency in Central Java;Robbins J. et Coll. Thyroid research. Amsterdam excerpta medica 1975 378: 501-504 |
Active substance: IODINE |
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Document reference: 30263 |
Study title: Infant Survivals is improved by Oral Iodine supplementation; Claudine Cobra. J. Nutr. 127 : 574-578, 1997Infant Survivals is improved by Oral Iodine supplementation; Claudine Cobra. J. Nutr. 127 : 574-578, 1997 |
Active substance: IODINE |
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Document reference: 30264 |
Study title: Caries increment in primary teeth after application of Duraphat fluoride varnish1982-grogzka |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1982-grogzka-Caries increment in primary teeth after application of Duraphat fluoride varnish.pdf |
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Document reference: 49108 |
Study title: Galli M, Lazzarin A, Moroni M, Zanussi C. In: Immunomodulation: New Frontiers and Advances. Fudenberg HH, Whitten HD, Ambrogi F, eds. New York, New York, USA; Plenum Press; 1984; 385-397. Treatment of recurrent viral infectious diseases by methisoprinol.Galli M, Lazzarin A, Moroni M, Zanussi C. In: Immunomodulation: New Frontiers and Advances. Fudenberg HH, Whitten HD, Ambrogi F, eds. New York, New York, USA; Plenum Press; 1984; 385-397. Treatment of recurrent viral infectious diseases by methisoprinol. |
Active substance: INOSINE |
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Document reference: 30108 |
Study title: Shoulder Pain in a young break-dancer evaluated with bone scintigraphy.Khoury JJ, Laberant N, Jerushalmi J. Clin Nucl Med 2009;34:916-7 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48750 |
Study title: Small rounded B-cell lymphoma of bone presented by limp, with a positive multifocal 99mTC MDP bone scintigraphy pattern and a negative 99mTc HMPAO-labled leukocytes studyPerez RH, Farto JCA, Arias IA, Regi AR, Vazquez JMP. J Pediatr Hematol Oncol 2008:30:443-446 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48753 |
Study title: Prevalence of deep venous thrombosis in the lower limbs and the pelvis and pulmonary embolism in patients with positive antiphospholipid antibodies. Ann Nucl Med. 2001 Dec;15(6):495-7. Kinuya K 2001 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48799 |
Study title: Pulmonary perfusion after endovascular stenting of pulmonary artery stenosis. J Nucl Med. 1995 Nov;36(11):2006-8. Oyen WJ 2006 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48817 |
Study title: Intravenous digital subtraction angiography for the evaluation of renal artery blood flow following the removal of a neuroblastoma; YAMAGIWA I; Surg. Today; 1994 vol.24 p.973-977Intravenous digital subtraction angiography for the evaluation of renal artery blood flow following the removal of a neuroblastoma; YAMAGIWA I; Surg. Today; 1994 vol.24 p.973-977 |
Active substance: IOVERSOL |
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Document reference: 30413 |
Study title: Nonoperative management of blunt liver trauma : the value of follow-up abdominal computed tomography scans; CUFF RF; Am. Surg.; 2000 vol.66 p.332 336Nonoperative management of blunt liver trauma : the value of follow-up abdominal computed tomography scans; CUFF RF; Am. Surg.; 2000 vol.66 p.332 336 |
Active substance: IOVERSOL |
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Document reference: 30420 |
Study title: Intestinal permeability and effects of Lactobacillus rhamnosus therapy in children with short bowel syndrome.Sentongo TA, Cohran V, Korff S, Sullivan C, Iyer K, Zheng X. J Pediatr Gastroenterol Nutr. 2008 Jan;46(1):41-7.Intestinal permeability and effects of Lactobacillus rhamnosus therapy in children with short bowel syndrome.Sentongo TA, Cohran V, Korff S, Sullivan C, Iyer K, Zheng X. J Pediatr Gastroenterol Nutr. 2008 Jan;46(1):41-7. |
Active substance: LACTULOSE |
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Document reference: 30992 |
Study title: The sugar absorption test in the evaluation of the gastrointestinal intolerance to bisphosphonates: studies with oral pamidronate.Twiss IM, Burggraaf J, Schoemaker RC, van Elburg RM, den Hartigh J, Cohen AF, Vermeij P. Clin Pharmacol Ther. 2001 Jun;69(6):431-7.The sugar absorption test in the evaluation of the gastrointestinal intolerance to bisphosphonates: studies with oral pamidronate.Twiss IM, Burggraaf J, Schoemaker RC, van Elburg RM, den Hartigh J, Cohen AF, Vermeij P. Clin Pharmacol Ther. 2001 Jun;69(6):431-7. |
Active substance: LACTULOSE |
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Document reference: 31000 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Lamioflur (drops) [AWB-AT] |
Active substance: Lamioflur |
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Document reference: 40045 |
Study title: A Multi-Center, Double-blind, Placebo-controlled, Parallel Evaluation of LAMICTAL as Add-on Therapy with Valproic Acid for the Treatment of Generalized Seizures in Paediatric and Adult Patients. |
Active substance: LAMOTRIGINE |
Study summary document link (including results): Study SCAA3001-Lamotrigine.xls |
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Document reference: 31009 |
Study title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Evaluation of Lamotrigine Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures [Data from the Open-label Continuation Phase] |
Active substance: LAMOTRIGINE |
Study summary document link (including results): Lamotrigine-Lamotrigine-LAM40097-ICHE3.pdf |
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Document reference: 31007 |
Study title: A multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of lamotrigine in subjects with neuropathic pain and inadequate pain relief with gabapentin, tricyclic antidepressants or non-narcotic analgesics. |
Active substance: LAMOTRIGINE |
Study summary document link (including results): Lamotrigine-Lamotrigine-NPP30010-ICHE3.pdf |
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Document reference: 31008 |
Study title: Open, multicentre study to evaluate the efficacy and tolerability of leuprorelin acetate 3,75 mg (enantone depot) in central precocious puberty treatment |
Active substance: LEUPRORELIN |
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Document reference: 31054 |
Study title: Open, multicentre, study to evaluate the efficacy and tolerability of leuprorelin acetate 3,75 mg (enantone depot) in central precocious puberty treatment |
Active substance: LEUPRORELIN |
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Document reference: 31044 |
Study title: A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY: 16-WEEK EVALUATION OF THE EFFICACY AND SAFETY OF LEVETIRACETAM (LEV) AS ADD-ON THERAPY IN ADULTS AND ADOLESCENTS OLDER THAN 16 YEARS SUFFERING FROM PARTIAL SEIZURES. |
Active substance: levetiracetam |
Study summary document link (including results): N01102 - Levetiracetam - RRCE05F1502.pdf |
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Document reference: 41537 |
Study title: A MULTICENTER, DOUBLE-BLIND, FOLLOW-UP TRIAL EVALUATING THE LONG-TERM SAFETY OF LEVETIRACETAM (1000 TO 3000 MG/DAY B.I.D.) AND CARBAMAZEPINE (400 TO 1200 MG/DAY ORAL B.I.D.), USED AS MONOTHERAPY IN SUBJECTS ( 16 YEARS) COMING FROM THE N01061 TRIAL. |
Active substance: levetiracetam |
Study summary document link (including results): N01093 - Levetiracetam - RRCE05L2109.pdf |
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Document reference: 41534 |
Study title: Caries preventive effect of Duraphat Varnish versus fluoride mouthrinses-5 year data1986-kirkegaard |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1986-kirkegaard-Caries preventive effect of Duraphat Varnish versus fluoride mouthrinses-5 year data.pdf |
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Document reference: 49113 |
Study title: Caries preventive effect of fluoride varnish application performed two or four times a year1990-seppa |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1990-seppa-Caries preventive effect of fluoride varnish application performed two or four times a year.pdf |
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Document reference: 49115 |
Study title: Pulmonary scintigraphic findings in children with pectus excavatum by the comparison of chest radiograph indices. Clin Nucl Med. 1992 Nov;17(11):874-6 Kao CH 1992 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48820 |
Study title: Quantitative lung perfusion scintigraphy in postoperative evaluation of congenital right ventricular outflow tract obstructive lesions. Clin Nucl Med. 1996 Jun;21(6):471-6. Kim JH 1996 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48814 |
Study title: Scintigraphic evaluation of the Eustachian tube functions. Rev Laryngol Otol Rhinol (Bord). 1999;120(2):123-5. Celen Z 1999 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48807 |
Study title: Surgery of congenital heart disease assessed by radionuclide scintigraphy. J Thorac Cardiovasc Surg. 1975 May;69(5):767-75. Gates GF 1975 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48830 |
Study title: Evaluation of oxymetazoline paediatric in the treatment of congestion.J Matern Child Health 1976; 1: 32-3, Cannon NL., Dalgleisch J., Franks HL. et al., 1976 |
Active substance: OXYMETAZOLINE |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48920 |
Study title: An open, randomized trila to evaluate if dose and frequency given bt American Heart Association coul be reduced (250 000 units x3 for 10 days)for streptococcal pharyngitis.Breese et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_3.xlsx |
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Document reference: 49034 |
Study title: Compare the effect of treatment with penicillin V in children with AOM for 5 and 10 days respectively and to investigate whether a higher dose of penicillin V is associated with a beneficial result.Ingvarsson et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_11.xlsx |
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Document reference: 49042 |
Study title: Gallamini A, Rigacci L, Merli F, Nassi L, Bosi A, Capodanno I et al.. The predictive value of positron emission tomography scanning performed after two courses of standard therapy on treatment outcome in advance stage Hodgkin's disease. [gallamini-2006]Haematologica 2006 Apr;91(4):475-81. Gallamini A 2006 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48655 |
Study title: Hain SF, O'Doherty MJ, Lucas JD, Smith MA. Nucl Med Commun. 1999 Sep;20(9):845-8. Fluorodeoxyglucose PET in the evaluation of amputations for soft tissue sarcoma. [hain-1999] Hain SF, O'Doherty MJ, Timothy AR, Leslie MD, Harper PG,. Fluorodeoxyglucose positron emission tomography in the evaluation of germ cell tumours at relapse. [hain-2000]Huddart RA. Br J Cancer. 2000 Oct;83(7):863-9. Hain SF 2000 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48656 |
Study title: Hutchings M, Mikhaeel NG, Fields PA, Nunan T, Timothy AR.. Epub 2005 Jun 6. Prognostic value of interim FDG-PET after two or three cycles of chemotherapy in Hodgkin lymphoma. [hutchings-2005]Ann Oncol. 2005 Jul;16(7):1160-8. Hutchings M 2005 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48661 |
Study title: Jacobs F, Thierens H, Piepsz A, Bacher K, van de Wiele C, Ham H et al. Optimised tracer-dependent dosage cards to obtain weight-independent effective doses. [jacobs 2005Eur J Nucl Med Mol Imaging 2005; 32 : 581 - 588. Jacobs F 2005 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48662 |
Study title: Jasper N, Däbritz J, Frosch M, Loeffler M, Weckesser M, Foell D.. Epub. Diagnostic value of [(18)F]-FDG PET/CT in children with fever of unknown origin or unexplained signs of inflammation. [jasper-2010] Eur J Nucl Med Mol Imaging. 2010 Jan;37(1):136-45. Jasper N 2010 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48663 |
Study title: Caries preventive effect of two fluoride varnishes and a fluoride mouthrinse1987-seppa, Caries Res. 1987:21: 375-379 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1987-seppa-Caries preventive effect of two fluoride varnishes and a fluoride mouthrinse.pdf |
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Document reference: 49114 |
Study title: Caries preventive effort of a fluoride-containing varnish (Duraphat) after 1 year s study1975-koch, Community Dentl Oral Epidemiol, 1975: 3: 262-266 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1975-koch-Cariespreventive effort of a fluoride-containing varnish (Duraphat) after 1 year s study.pdf |
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Document reference: 49102 |
Study title: Postoperative adjuvant locoregional chemotherapy in patients with hepatocellular carcinoma. ; Izumi-R. Hepato-Gastroenterology, 1996, Vol/Iss/Pg. 43/12 (1415-1420)Postoperative adjuvant locoregional chemotherapy in patients with hepatocellular carcinoma. ; Izumi-R. Hepato-Gastroenterology, 1996, Vol/Iss/Pg. 43/12 (1415-1420) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30304 |
Study title: Preoperative percutaneous portal vein embolization: Evaluation of adverse events in 188 patients. ; Di-Stefano-D-R. Radiology, 2005, Vol/Iss/Pg. 234/2 (625-630)Preoperative percutaneous portal vein embolization: Evaluation of adverse events in 188 patients. ; Di-Stefano-D-R. Radiology, 2005, Vol/Iss/Pg. 234/2 (625-630) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30308 |
Study title: Prevalence of goitre and hypothyroidism in Southern Tanzania: Effect of iodised oil on thyroid hormone deficiency. ; Wachter-W. Journal of Epidemiology and Community Health, 1986, Vol/Iss/Pg. 40/1 (86-91)Prevalence of goitre and hypothyroidism in Southern Tanzania: Effect of iodised oil on thyroid hormone deficiency. ; Wachter-W. Journal of Epidemiology and Community Health, 1986, Vol/Iss/Pg. 40/1 (86-91) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30311 |
Study title: Tc-99m MAA total-body imaging to detect intrapulmonary right-to-left shunts and to evaluate the therapeutic effect in pulmonary arteriovenous shunts. Clin Nucl Med. 1996 Mar;21(3):197-202. Lu G 1996 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48815 |
Study title: The contribution of perfusion scintigraphy in the evaluation of children suffering from recurrent localized pneumonia. Eur J Nucl Med. 1990;17(3-4):152-5. Hardoff R 1990 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48824 |
Study title: Tc-99m MAA SPECT in pectus excavatum: assessment of perfusion volume changes after correction by the Nuss procedure. Clin Nucl Med. 2005 Dec;30(12):779-82. Kinuya K 2005 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48791 |
Study title: Hematogenous pyogenic vertebral osteomyelitis: diagnostic value of radionuclide bone imaging.Adatepe MH, Powell OM, Isaacs GH, Nichols K, Cefola R. J Nucl Med 1986 Nov;27(11):1680-5. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48523 |
Study title: 201Tl scintigraphic evaluation of tumor mass and viability of bone and soft-tissue tumors.Tsuda T, Kubota M, Yoshida S, Shibata M, Wakabayashi J, Obata H, et al. Kaku Igaku 1994 Dec;31(12):1477-94 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48762 |
Study title: (99m)Tc-MDP scintigraphic findings in children with leukemia: value of early and delayed whole-body imagingShalaby-Rana E, Majd M. J Nucl Med 2001 Jun;42(6):878-83 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48514 |
Study title: Determine concentration of pcV in serum and in middle ear exudate and to isolate bacteria in the ear exsudate during the course of treatment with penicillin V in acute otitis media in children.Ingvarsson et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_15.xlsx |
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Document reference: 49046 |
Study title: determine concentration of pcV in serum and in middle ear exudate at various intervals of administration of different doses and to correlate the susceptibility in vitro of H Infl to pcVKamme et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_5.xlsx |
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Document reference: 49036 |
Study title: Double-blinded, Randomized parallel groups design trial, the primary objective of the study was to evaluate the taste of two formulations of phenoxymethylpenicillin suspension in children. The secondary objectives were to study age-related differences in taste perception, to evaluate the acceptability of the suspensions, and to determine patient compliance.Bagger-Sjöbäck et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_12.xlsx |
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Document reference: 49043 |
Study title: Accurate preoperative evaluation of liver mass lesions without fine- needle biopsy. ; Torzilli-G. Hepatology, 1999, Vol/Iss/Pg. 30/4 (889-893)Accurate preoperative evaluation of liver mass lesions without fine- needle biopsy. ; Torzilli-G. Hepatology, 1999, Vol/Iss/Pg. 30/4 (889-893) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30217 |
Study title: Adjuvant intra-arterial iodine-131-labelled lipiodol for resectable hepatocellular carcinoma: A prospective randomised trial. ; Lau-W-Y. Lancet, 06 MAR 1999, Vol/Iss/Pg. 353/9155 (797-801)Adjuvant intra-arterial iodine-131-labelled lipiodol for resectable hepatocellular carcinoma: A prospective randomised trial. ; Lau-W-Y. Lancet, 06 MAR 1999, Vol/Iss/Pg. 353/9155 (797-801) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30218 |
Study title: Kabickova E, Sumerauer D, Cumlivska E, Drahokoupilova E, Nekolna M, ChanovaM, et al.. The predictive value of positron emission tomography scanning performed after two courses of standard therapy on treatment outcome in advanced stage Hodgkin's disease. [kabickova-2006]Haematologica. 2006 Apr;91(4):475-81. Kabickova E 2006 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48664 |
Study title: Kamel E, Hany TF, Burger C, Treyer V, Lonn AH, von Schulthess GK, et al.. CT vs 68Ge attenuation correction in a combined PET/CT system: evaluation of the effect of lowering the CT tube current. [kamel-2002]Eur J Nucl Med Mol Imaging. 2002 Mar;29(3):346-50. Kamel E 2002 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48665 |
Study title: Kaneta T, Hakamatsuka T, Yamada T, Takase K, Sato A, Higano S, et al.. FDG PET in solitary metastastic/secondary tumor of the kidney: a report of three cases and a review of the relevant literature. [kaneta-2006]Ann Nucl Med. 2006 Jan;20(1):79-82. Kaneta T 2006 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48666 |
Study title: Kostakoglu L, Leonard JP, Kuji I, Coleman M, Vallabhajosula S, Goldsmith SJ.. Comparison of fluorine-18 fluorodeoxyglucose positron emission tomography and Ga-67 scintigraphy in evaluation of lymphoma. [kostakaglu-2002]Cancer. 2002 Feb 15;94(4):879-88. Kostakoglu L 2002 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48670 |
Study title: Reversibility of severe hypothyroidism with supplementary iodine in patients with endemic cretinism. ; Vanderpas-J-B. New England Journal of Medicine, 1986, Vol/Iss/Pg. 315/13 (791-795).Reversibility of severe hypothyroidism with supplementary iodine in patients with endemic cretinism. ; Vanderpas-J-B. New England Journal of Medicine, 1986, Vol/Iss/Pg. 315/13 (791-795). |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30321 |
Study title: Selenium deficiency mitigates hypothyroxinemia in iodine-deficient subjects; Jean B Vanderpas. Am J Clin Nutr Suppl 1993 ;57 :271S-5S.Selenium deficiency mitigates hypothyroxinemia in iodine-deficient subjects; Jean B Vanderpas. Am J Clin Nutr Suppl 1993 ;57 :271S-5S. |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30322 |
Study title: Spontaneous scalp arteriovenous fistula in a child with Hartnup disease. ; Kim-D-M. Journal of Endovascular Therapy, 2004, Vol/Iss/Pg. 11/3 (348-350)Spontaneous scalp arteriovenous fistula in a child with Hartnup disease. ; Kim-D-M. Journal of Endovascular Therapy, 2004, Vol/Iss/Pg. 11/3 (348-350) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30324 |
Study title: Comparison of planar scintigraphy alone and with SPECT for the initial evaluation of femoral neck stress fracture.Bryant LR, Song WS, Banks KP, Bui-Mansfield LT, Bradley YC. AJR 2008;191:1010-1015. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48584 |
Study title: Hematogenous Pyogenic Vertebral Osteomyelitis:Diagnostic Value of Radionucide Bone ImagingMustafa H. Adatepe, Oscar M. Powell, Gilbert H. Isaacs, Kenneth Nichols, and Raymond Cefola. J Nucl Med 27:1680-1685, 1986 |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48832 |
Study title: A protocol of plain radiographs, hip ultrasound, and triple phase bone scans in the evaluation of the painful pediatric hip.Alexander JE, Seibert JJ, Aronson J, Williamson SL, Glasier CM, Rodgers AB, et al. Clin Pediatr 1988 Apr;27(4):175-81. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48527 |
Study title: Accumulation of Tc-99m MDP in diaphragm and retroperitoneum of a battered child. Sty JR, Carmody TJ, Ruiz ME. Clin Nucl Med. 1995 Oct;20(10):931. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43583 |
Study title: Activation of the growth plates on three-phase bone scintigraphy: the explanation for the overgrowth of fractured femurs.Elba CSC, Etchebehere EC, Caron M, Pereira JA, Lima MC, Santos AO, et al. Eur J Nucl Med 2001 Jan;28(1):72-80. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48719 |
Study title: Craniofacial cavernous venous malformations: Percutaneous sclerotherapy with use of ethanolamine oleate. ;Choi-Y-H. Journal of Vascular and Interventional Radiology, 2002, Vol/Iss/Pg. 13/5 (475-482)Craniofacial cavernous venous malformations: Percutaneous sclerotherapy with use of ethanolamine oleate. ;Choi-Y-H. Journal of Vascular and Interventional Radiology, 2002, Vol/Iss/Pg. 13/5 (475-482) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30227 |
Study title: Diagnostic and therapeutic value of lymphography in persistent postoperative chylothorax. ; Thambo-J-B. Archives des Maladies du Coeur et des Vaisseaux, 2004, Vol/Iss/Pg. 97/5 (546-548)Diagnostic and therapeutic value of lymphography in persistent postoperative chylothorax. ; Thambo-J-B. Archives des Maladies du Coeur et des Vaisseaux, 2004, Vol/Iss/Pg. 97/5 (546-548) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30229 |
Study title: J Invasive Cardiol. 2003 Mar;15(3):133-8. Early and late reactions following the use of iopamidol 340, iomeprol 350 and iodixanol 320 in cardiac catheterization. Sutton AG, Finn P, Campbell PG, Price DJ, Hall JA, Stewart MJ, Davies A, Linker NJ, De Belder MA. J Invasive Cardiol. 2003 Mar;15(3):133-8. Early and late reactions following the use of iopamidol 340, iomeprol 350 and iodixanol 320 in cardiac catheterization. Sutton AG, Finn P, Campbell PG, Price DJ, Hall JA, Stewart MJ, Davies A, Linker NJ, De Belder MA. |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30346 |
Study title: Clinical evaluations on the biocompatibility- Valutazioni cliniche sulla biocompatibilitaGatto 1989 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): Gatto 1989 Valutazioni cliniche sulla biocompatibilita.pdf |
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Document reference: 49167 |
Study title: Collective preschool caries prevention using a fluoride-containing varnish] [Article in German] |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42543 |
Study title: Comments on the biocompatibility - Osservazioni sulla biocompatibilitaGallusi 1988 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): Gallusi 1988 Osservazioni sulla biocompatibilita.pdf |
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Document reference: 49165 |
Study title: Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44191 |
Study title: Reduced radiation dose helical chest CT : effect on reader evaluation of structures and lung findings;MAYO JR; Radiology; 2004 vol.232 p.749 756Reduced radiation dose helical chest CT : effect on reader evaluation of structures and lung findings;MAYO JR; Radiology; 2004 vol.232 p.749 756 |
Active substance: IOVERSOL |
Study summary document link (including results): |
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Document reference: 30425 |
Study title: Lactobacillus GG in the prevention of antibiotic-associated diarrhea in children – VANDERHOOF J.A., WHITNEY D.B. and al. – 1999.Lactobacillus GG in the prevention of antibiotic-associated diarrhea in children – VANDERHOOF J.A., WHITNEY D.B. and al. – 1999. |
Active substance: LACTIC ACID PRODUCING ORGANISMS AND COMBINATIONS |
Study summary document link (including results): |
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Document reference: 30966 |
Study title: Lactobacillus reuteri as a therapeutic agent in acute diarrhea in young children – SHORNIKOVA A.V., CASAS I.A. and al. – 1997. Lactobacillus reuteri as a therapeutic agent in acute diarrhea in young children – SHORNIKOVA A.V., CASAS I.A. and al. – 1997. |
Active substance: LACTIC ACID PRODUCING ORGANISMS AND COMBINATIONS |
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Document reference: 30967 |
Study title: Lactobacillus therapy for acute infectious diarrhea in children: a meta analysis – VAN NIEL C.W., FEUDTNER C. and al. – 2005. Lactobacillus therapy for acute infectious diarrhea in children: a meta analysis – VAN NIEL C.W., FEUDTNER C. and al. – 2005. |
Active substance: LACTIC ACID PRODUCING ORGANISMS AND COMBINATIONS |
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Document reference: 30968 |
Study title: Mild iodine deficiency is associated with elevated hearing thresholds in children in Benin. ; Van-den-Briel-T European Journal of Clinical Nutrition, 2001, Vol /Iss/Pg. 55/9 (763-768)Mild iodine deficiency is associated with elevated hearing thresholds in children in Benin. ; Van-den-Briel-T European Journal of Clinical Nutrition, 2001, Vol /Iss/Pg. 55/9 (763-768) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30288 |
Study title: Evaluation of the efficacy and safety of Somatuline sustained release form in adolescent with constitutive tall stature |
Active substance: LANREOTIDE |
Study summary document link (including results): |
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Document reference: 31013 |
Study title: A phase I, multi-centre, randomised, parallel group, open-label, single- and repeated-dose studies to evaluate the pharmacokinetic and pharmacodynamic profile of lansoprazole in neonates with clinically-evident GERD |
Active substance: LANSOPRAZOLE |
Study summary document link (including results): Lansoprazole_c03-042-synopsis.pdf |
View full study record |
Document reference: 47606 |
Study title: Pulmonary complications after hepatic artery chemoembolization or infusion via the inferior phrenic artery for primary liver cancer. ; Tajima-T. Journal of Vascular and Interventional Radiology, 01 SEP 2002, Vol/Iss/Pg. 13/9 I (893-900)Pulmonary complications after hepatic artery chemoembolization or infusion via the inferior phrenic artery for primary liver cancer. ; Tajima-T. Journal of Vascular and Interventional Radiology, 01 SEP 2002, Vol/Iss/Pg. 13/9 I (893-900) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30314 |
Study title: Pulmonary embolism: A fatal complication of arterial chemoembolization for advanced hepatocellular carcinoma. ;Czauderna-P. Journal of Pediatric Surgery, 2005, Vol/Iss/Pg. 40/10 (1647-1650)Pulmonary embolism: A fatal complication of arterial chemoembolization for advanced hepatocellular carcinoma. ;Czauderna-P. Journal of Pediatric Surgery, 2005, Vol/Iss/Pg. 40/10 (1647-1650) |
Active substance: IODINE |
Study summary document link (including results): |
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Document reference: 30315 |
Study title: A multicenter European randomized parallel-group phase III study to evaluate safety and efficacy of rHuG-CSF (lenograstim) in the first 12 weeks of the treatment of de novo severe aplastic anemia - 1998 (Blood, 92 (10) suppl 1 : abs 1551, p 376 a) |
Active substance: LENOGRASTIM |
Study summary document link (including results): |
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Document reference: 31028 |
Study title: A multicenter non-randomized open-label dose-escalating phase I-II study (pharmakokinetic and dose-ranging) of intravenous or subcutaneous administration of rG-CSF for a maximum of 21 days to reduce duration of neutropenia in children having received COPAdM1 and / or COPAdM2 chemotherapy course for advanced lymphoma |
Active substance: LENOGRASTIM |
Study summary document link (including results): |
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Document reference: 31029 |
Study title: A Phase III multicenter, double blind, randomized, parallel-group, vehicle controlled study to evaluate the safety and efficacy of 5µg/kg/day recombinant Granulocyte Colony Stimulating Factor (rHuG-CSF) in the treatment of patients who have undergone bone marrow transplantation (BMT). |
Active substance: LENOGRASTIM |
Study summary document link (including results): |
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Document reference: 31030 |
Study title: An open label, multicenter study to evaluate the pharmacokinetics of 5uG / KG / day of recombinant granulocyte colony stimulating factor (rHuG-CSF) in the treatment of pediatric patients who have undergone bone marrow transplantation (BMT) - No author - No date - Clinical study documentation GHBA 271 study - Vol. 6 - |
Active substance: LENOGRASTIM |
Study summary document link (including results): |
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Document reference: 31031 |
Study title: 99Tcm-MAA lung scintigraphy in patients with Behçet's disease: its value and correlation with clinical course and other diagnostic modalities. Nucl Med Commun. 2000 Feb;21(2):171-9. Caglar M 2000 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48804 |
Study title: Arteriovenous shunt measurement during endovascular therapy for cerebrospinal lesions. AJNR Am J Neuroradiol. 1997 Oct;18(9):1679-89. Mariani L 1997 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48813 |
Study title: Evaluation of growth in children using quantitative bone scintigraphy.Celen Z, Zincirkeser S, Ozkiliç S, Nacar F. J Int Med Res 1999;27(6):286-91. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 48590 |
Study title: Bilateral pulmonary artery aneurysms in a patient with Behcet syndrome: evaluation with radionuclide angiography and V/Q lung scanning. Clin Nucl Med. 1998 Nov;23(11):735-8. Basoglu T 1998 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
View full study record |
Document reference: 48811 |
Study title: Evaluate in children the taste of two different phenoxymethylpenicillins, one containing aspartame.Norstedt |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_13.xlsx |
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Document reference: 49044 |
Study title: Investigate the minimum age limit in children accepting penicillin administered as tablets instead of mixture.Edvardsson et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_14.xlsx |
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Document reference: 49045 |
Study title: Open-label, single-arm, multicenter study to evaluate the efficacy and tolerability of Creon for children in infants with pancreatic exocrine insufficiency caused by cystic fibrosis |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-S248-3003.pdf |
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Document reference: 47673 |
Study title: Efficacy of acrivastine with pseudoephedrine in treatment of allergic rhinitis due to ragweed. Ann Allergy Asthma Immunol 1996; 76(2):204-8 Efficacy of acrivastine with pseudoephedrine in treatment of allergic rhinitis due to ragweed. Ann Allergy Asthma Immunol 1996; 76(2):204-8 |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 33636 |
Study title: Valuatazioni su pazienti pediatrici recoverati per diarrea acuta dal 1990 al 1996 (valuations about paeditric admissions inhospital for acute diarrhea from 1990 to 1996) - Casini T. and al. - 1997 (Ped. Med. Chir., 1997, 19: 31-5)Valuatazioni su pazienti pediatrici recoverati per diarrea acuta dal 1990 al 1996 (valuations about paeditric admissions inhospital for acute diarrhea from 1990 to 1996) - Casini T. and al. - 1997 (Ped. Med. Chir., 1997, 19: 31-5) |
Active substance: NIFUROXAZIDE |
Study summary document link (including results): |
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Document reference: 47064 |
Study title: Phase I, multi-centre, randomised, parallel group, open-label, single- and repeated-dose studies to evaluate the pharmacokinetic and pharmacodynamic profile of lansoprazole in infants with clinically-evident GERD |
Active substance: LANSOPRAZOLE |
Study summary document link (including results): Lansoprazole_c03-043-synopsis.pdf |
View full study record |
Document reference: 47608 |
Study title: Modafinil-induced hippocampal activation in narcolepsyNeuroscience Letters 422 (2007) 91–96. Yu Kyeong Kima, In-Young Yoon b,∗, Yoon-Kyung Shin b, Sang Soo Choa, Sang Eun Kima. |
Active substance: Steripet |
Study summary document link (including results): kim-2007.pdf |
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Document reference: 48735 |
Study title: Moll AC, Hoekstra OS, Imhof SM, Comans EF, Schouten-van Meeteren AY, van der Valk P, et al. Ophthalmic Genet. 2004 Mar;25(1):31-5. Fluorine-18 fluorodeoxyglucose positron emission tomography (PET) to detect vital retinoblastoma in the eye: preliminary experience. [moll-2004]Moll AC 2004 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48679 |
Study title: Myocardial Viability Assessed by Positron Emission Tomography in Infants and Children After the Arterial Switch Operation and Suspected Infarction(J Am Coll Cardiol 2000;36:1676–83). Carsten Rickers, MD,* Karin Sasse, MD,* Ralph Buchert, PHD,† Heiko Stern, MD,* Jo¨rg van den Hoff, PHD,‡ Martin Lu¨beck, MD,† Jochen Weil, MD* |
Active substance: Steripet |
Study summary document link (including results): rickers-2000.pdf |
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Document reference: 48743 |
Study title: Djelovanje aminofluorida - elmex gelee na: Effect of amine fluorideRajic 1977 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): Rajic 1977 Djelovanje aminofluorida - elmex gelee na.pdf |
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Document reference: 49174 |
Study title: The caries preventive effect of a fluoride varnish in the fissures of the first permanent molar1984-holm |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1984-holm-The caries preventive effect of a fluoride varnish in the fissures of the first permanent molar.pdf |
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Document reference: 49110 |
Study title: The caries-preventive effect of a fluoride varnish in the fissures of the first permanent molar. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42369 |
Study title: Diagnosis of thrombosis of the deep veins of the lower extremities and pelvis and pulmonary thromboembolism using 99Tcm human serum albumin macroaggregates. Nucl Med Commun. 1989 Mar;10(3):141-7. Stevan M 1989 |
Active substance: TECHNETIUM (99m) |
Study summary document link (including results): 2011-09 GE response Maasol List of published articles.doc |
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Document reference: 48826 |
Study title: [Bone isotope hypofixation in algodystrophy in children]Le Loet X, Lefort J, Daragon A, Derumeaux B, Deshayes P. Rev Rhum Mal Osteoartic. 1987 Jan;54(1):53. French. No abstract available |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43881 |
Study title: An open study to Investigating the safety and efficiacy of Dextran-Ringer after blood loss during surgery.Zetterström et al. (1986-03-09) |
Active substance: Dextran |
Study summary document link (including results): |
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Document reference: 48940 |
Study title: Clinical evaluation of priming solutions for pump oxygenator perfusion. Ann Thorac Surg. 1975 May;19(5):529-36. Lee WH Jr, Rubin JW, Huggins MP. |
Active substance: Dextran |
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Document reference: 48899 |
Study title: Dextran therapy for pregnancy-associated deep thrombophlebitis.Wallach RC. Am J Obstet Gynecol. 1972 Mar;112(5):613-8. |
Active substance: Dextran |
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Document reference: 48939 |
Study title: Effect of dextran on blood volume and interactions with volume regulatory systems.Haldemann G, Schaer H, Spring C, Frey P, Gebauer U, Hossli G. Intensive Care Med. 1979 Mar;5(1):11-4. |
Active substance: Dextran |
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Document reference: 48937 |
Study title: Novak L, Emri M, Molnar P, Balkay L, Lengyel Z. Subcortical [18F]fluorodeoxyglucose uptake in lesional epilepsy in patients with intracranial tumour. [novak-2004]Tron L. Nucl Med Commun. 2004 Feb;25(2):123-8. Novak L 2004 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48685 |
Study title: PET and PET/CT in Pediatric Oncology.Semin Nucl Med 37:316-331. Hossein Jadvar, MD, PhD, MPH, MBA,* Leonard P. Connolly, MD,† Frederic H. Fahey, DSc,† and Barry L. Shulkin, MD, MBA‡ |
Active substance: Steripet |
Study summary document link (including results): jadvar-2007.pdf |
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Document reference: 48732 |
Study title: PET in pediatric diseasesRadiol Clin N Am 43 (2005) 135 – 152 .Hossein Jadvar, MD, PhDa,b,*, Abass Alavi, MDc, Ayse Mavi, MDd, Barry L. Shulkin, MD, MBAe |
Active substance: Steripet |
Study summary document link (including results): jadvar-2005.pdf |
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Document reference: 48731 |
Study title: Picardi M, De Renzo A, Pane F, Nicolai E, Pacelli R, Salvatore M, et al.. Randomized comparison of consolidation radiation versus observation in bulky Hodgkin's lymphoma with post-chemotherapy negative positron emission tomography scans. [picardi-2007]Leuk Lymphoma. 2007 Sep;48(9):1721-7. Picardi M 2007 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48689 |
Study title: Chicaud P, Demange J, Drouin P, Debry G. Action du fénofibrate chez des enfants hypercholestérolémiques. Recul de 18 mois. La Presse médicale 1984; 13:417-419Chicaud P, Demange J, Drouin P, Debry G. Action du fénofibrate chez des enfants hypercholestérolémiques. Recul de 18 mois. La Presse médicale 1984; 13:417-419 |
Active substance: FENOFIBRATE |
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Document reference: 27028 |
Study title: Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44113 |
Study title: Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44190 |
Study title: So Y, Chung JK, Seong SC, Sohn YJ, Kang HS, Lee DS, Lee MC. Usefulness of 99Tcm-MDP knee SPET for pre-arthroscopic evaluation of patients with internal derangements of the knee. Nucl Med Commun. 2000 Jan;21(1):103-9. So Y, Chung JK, Seong SC, Sohn YJ, Kang HS, Lee DS, Lee MC. Usefulness of 99Tcm-MDP knee SPET for pre-arthroscopic evaluation of patients with internal derangements of the knee. Nucl Med Commun. 2000 Jan;21(1):103-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43490 |
Study title: Tc-99m MDP bone and Ga-67 citrate scintigraphy of Erdheim-Chester disease in a child. Sohn MH, Kim MW, Kang YH, Jeong HJ. Clin Nucl Med. 2006 Feb;31(2):90-2. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43379 |
Study title: Spencer JD, Maisey M. A prospective scintigraphic study of avascular necrosis of bone in renal transplant patients. Clin Orthop Relat Res. 1985 Apr;(194):125-35. Spencer JD, Maisey M. A prospective scintigraphic study of avascular necrosis of bone in renal transplant patients. Clin Orthop Relat Res. 1985 Apr;(194):125-35. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43948 |
Study title: Magill HL, Strang MS. Paraspinal metastasis of Wilm's tumor visualized on bone imaging. J Nucl Med. 1981 May;22(5):481-2. No abstract available. Magill HL, Strang MS. Paraspinal metastasis of Wilm's tumor visualized on bone imaging. J Nucl Med. 1981 May;22(5):481-2. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44126 |
Study title: Maigne JY, Boulahdour H, Chatellier G. Value of quantitative radionuclide bone scanning in the diagnosis of sacroiliac joint syndrome in 32 patients with low back pain. Eur Spine J. 1998;7(4):328-31. Maigne JY, Boulahdour H, Chatellier G. Value of quantitative radionuclide bone scanning in the diagnosis of sacroiliac joint syndrome in 32 patients with low back pain. Eur Spine J. 1998;7(4):328-31. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43524 |
Study title: Malizos KN, Soucacos PN, Vragalas V, Dailiana ZH, Schina I, Fotopoulos A. Three phase bone scanning and digital arteriograms for monitoring vascularized fibular grafts in femoral head necrosis. Int Angiol. 1995 Sep;14(3):319-26. Malizos KN, Soucacos PN, Vragalas V, Dailiana ZH, Schina I, Fotopoulos A. Three phase bone scanning and digital arteriograms for monitoring vascularized fibular grafts in femoral head necrosis. Int Angiol. 1995 Sep;14(3):319-26. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43586 |
Study title: Sun SS, Tsai SC, Su CC, Kao CH. Diffuse liver and spleen accumulation on Tc-99m methylene diphosphonate bone scan. Semin Nucl Med. 2001 Jul;31(3):253-4. No abstract available. Sun SS, Tsai SC, Su CC, Kao CH. Diffuse liver and spleen accumulation on Tc-99m methylene diphosphonate bone scan. Semin Nucl Med. 2001 Jul;31(3):253-4. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43451 |
Study title: Sternal uptake on bone scintigraphy: age-related variants. Syed GM, Fielding HW, Collier BD. Nucl Med Commun. 2005 Mar;26(3):253-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43390 |
Study title: Sziklas JJ, Vento JA, Spencer RP, Rosenberg RJ. Radiogallium accumulation in heterotopic bone. Clin Nucl Med. 1985 May;10(5):376. No abstract available. Sziklas JJ, Vento JA, Spencer RP, Rosenberg RJ. Radiogallium accumulation in heterotopic bone. Clin Nucl Med. 1985 May;10(5):376. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43945 |
Study title: Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44228 |
Study title: Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44275 |
Study title: Prolonged low-back pain in young athletes: a prospective case series study of findings and prognosis. Kujala UM, Kinnunen J, Helenius P, Orava S, Taavitsainen M, Karaharju E. Eur Spine J. 1999;8(6):480-4. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43496 |
Study title: "Caravati EM, Heileson HL, Jones M. Treatment of severe pediatric ethylene glycol intoxication without hemodialysis. J Toxicol Clin Toxicol. 2004;42(3):255-9. " "Caravati EM, Heileson HL, Jones M. Treatment of severe pediatric ethylene glycol intoxication without hemodialysis. J Toxicol Clin Toxicol. 2004;42(3):255-9. " |
Active substance: FOMEPIZOLE |
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Document reference: 28469 |
Study title: "Casavant MJ. Fomepizole in the treatment of poisoning. Pediatrics. 2001 Jan;107(1):170. " "Casavant MJ. Fomepizole in the treatment of poisoning. Pediatrics. 2001 Jan;107(1):170. " |
Active substance: FOMEPIZOLE |
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Document reference: 28472 |
Study title: Pan MH, Wu YW, Yen RF, Tzen KY, Liao SL, Kao CH. Different fibrovascularization rate between coralline hydroxyapatite and high density porous polyethylene (Medpore) measured by 99mTc-MDP bone scintigraphy 6 months after intraorbital implantation. Nucl Med Commun. 2003 Dec;24(12):1237-41. Pan MH, Wu YW, Yen RF, Tzen KY, Liao SL, Kao CH. Different fibrovascularization rate between coralline hydroxyapatite and high density porous polyethylene (Medpore) measured by 99mTc-MDP bone scintigraphy 6 months after intraorbital implantation. Nucl Med Commun. 2003 Dec;24(12):1237-41. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44245 |
Study title: Panoutsopoulos G, Ilias I, Parcharidou A, Christakopoulou I. [Intense uptake of 99mTc-MDP in primary abdominal neuroblastoma] Rev Esp Med Nucl. 2002 Jul;21(4):294-5. Spanish. No abstract available. Panoutsopoulos G, Ilias I, Parcharidou A, Christakopoulou I. [Intense uptake of 99mTc-MDP in primary abdominal neuroblastoma] Rev Esp Med Nucl. 2002 Jul;21(4):294-5. Spanish. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43437 |
Study title: Ibis E, Erbay G, Aras G, Isitman AT, Krasnow AZ, Collier BD. Three-phase bone scintigraphy in Maffucci's syndrome. Clin Nucl Med. 1992 Jun;17(6):505-6. No abstract available. Ibis E, Erbay G, Aras G, Isitman AT, Krasnow AZ, Collier BD. Three-phase bone scintigraphy in Maffucci's syndrome. Clin Nucl Med. 1992 Jun;17(6):505-6. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43696 |
Study title: Reinert S, Widlitzek H, Venderink DJ. The value of magnetic resonance imaging in the diagnosis of mandibular osteomyelitis. Br J Oral Maxillofac Surg. 1999 Dec;37(6):459-63. Reinert S, Widlitzek H, Venderink DJ. The value of magnetic resonance imaging in the diagnosis of mandibular osteomyelitis. Br J Oral Maxillofac Surg. 1999 Dec;37(6):459-63. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43493 |
Study title: Rencus T, Smith J, Munn S, Elgazzar A. Displaced uterus simulating aneurysm on a multiphase bone scan. Clin Nucl Med. 2003 Jul;28(7):574-6. No abstract available. Rencus T, Smith J, Munn S, Elgazzar A. Displaced uterus simulating aneurysm on a multiphase bone scan. Clin Nucl Med. 2003 Jul;28(7):574-6. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43418 |
Study title: Rhoad RC, Davidson RS, Heyman S, Dormans JP, Drummond DS. Pretreatment bone scan in SCFE: a predictor of ischemia and avascular necrosis. J Pediatr Orthop. 1999 Mar-Apr;19(2):164-8. Rhoad RC, Davidson RS, Heyman S, Dormans JP, Drummond DS. Pretreatment bone scan in SCFE: a predictor of ischemia and avascular necrosis. J Pediatr Orthop. 1999 Mar-Apr;19(2):164-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43511 |
Study title: Riebel T, Knop J, Winkler K, Delling G. [Comparative x-ray and nuclear medical studies of osteosarcomas to evaluate the effectiveness of preoperative chemotherapy] Rofo. 1986 Oct;145(4):365-72. German. Riebel T, Knop J, Winkler K, Delling G. [Comparative x-ray and nuclear medical studies of osteosarcomas to evaluate the effectiveness of preoperative chemotherapy] Rofo. 1986 Oct;145(4):365-72. German. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43891 |
Study title: Specific or superfluous? Doubtful clinical value of granulocyte scintigraphy in osteomyelitis in children. Kaiser S, Jacobsson H, Hirsch G. J Pediatr Orthop B. 2001 Apr;10(2):109-12. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43453 |
Study title: Evaluate the safety of ampicillin suppositories with special emphasis on local intolerance reactions in pediatric patients. The secondary objective was to evaluate the short term efficiacy in the treatment of acute otitis media. The study was comparative against amoxycillin suspension.Bagger-Sjöbäck et al. (1986-11-28) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_19.xlsx |
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Document reference: 49018 |
Study title: Kumar R, Dilip S, Padhy AK, Malhotra R, Malhotra A, Machineni S, Sharma R. Three-phase bone imaging in the early diagnosis of osteochondritis dissecans of the patella. Clin Nucl Med. 1998 Aug;23(8):540-1. No abstract available. Kumar R, Dilip S, Padhy AK, Malhotra R, Malhotra A, Machineni S, Sharma R. Three-phase bone imaging in the early diagnosis of osteochondritis dissecans of the patella. Clin Nucl Med. 1998 Aug;23(8):540-1. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43528 |
Study title: Nielsen PT, Hedeboe J, Thommesen P. Bone scintigraphy in the evaluation of fracture of the carpal scaphoid bone. Acta Orthop Scand. 1983 Apr;54(2):303-6. Nielsen PT, Hedeboe J, Thommesen P. Bone scintigraphy in the evaluation of fracture of the carpal scaphoid bone. Acta Orthop Scand. 1983 Apr;54(2):303-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44042 |
Study title: Nishiyama Y, Yamamoto Y, Toyama Y, Satoh K, Ohkawa M, Tanabe M. Diagnostic value of TI-201 and three-phase bone scintigraphy for bone and soft-tissue tumors. Clin Nucl Med. 2000 Mar;25(3):200-5. Nishiyama Y, Yamamoto Y, Toyama Y, Satoh K, Ohkawa M, Tanabe M. Diagnostic value of TI-201 and three-phase bone scintigraphy for bone and soft-tissue tumors. Clin Nucl Med. 2000 Mar;25(3):200-5. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43491 |
Study title: Normal anatomic variant: scintigraphy of the ischiopubic synchondrosis. Cawley KA, Dvorak AD. Wilmot MD. Nucl Med 1983 Jan;24{1):14-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48468 |
Study title: "Tenenbein M. Recent advancements in pediatric toxicology. Pediatr Clin North Am. 1999 Dec;46(6):1179-88, vii. Review. " "Tenenbein M. Recent advancements in pediatric toxicology. Pediatr Clin North Am. 1999 Dec;46(6):1179-88, vii. Review. " |
Active substance: FOMEPIZOLE |
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Document reference: 28473 |
Study title: A 12-week randomized, multicenter, double-blind, double-dummy, placebo and active controlled, parallel group study evaluating the safety and efficacy of Formoterol fumarate (10 µg b.i.d.) delivered by the multi-dose dry powder inhaler (MDDPI) versus place |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258F2302 Art45 listing 2011.xls |
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Document reference: 47795 |
Study title: A 12-week randomized, multicenter, double-blind, double-dummy, placebo and active controlled, parallel group study evaluating the safety, efficacy, and pharmacokinetics of Foradil (formoterol fumarate) (10 mg bid) delivered by the multi-dose dry powder in |
Active substance: FORMOTEROL |
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Document reference: 47796 |
Study title: Ishibashi K, Miyamae T. [Classification of bone scintigrams in hemodialysis patients] Kaku Igaku. 1985 Mar;22(3):367-76. Japanese. No abstract available. Ishibashi K, Miyamae T. [Classification of bone scintigrams in hemodialysis patients] Kaku Igaku. 1985 Mar;22(3):367-76. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43952 |
Study title: Uterine blush mimicking a hypervascular tumour in the pelvis as demonstrated by a triple-phase bone scan. Tzen KY, Yen TC. Nucl Med Commun. 1998 Jun;19(6):605-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43509 |
Study title: Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43732 |
Study title: Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44173 |
Study title: Assessment of growth activity in the mandibular condyles by single-photon emission computed tomography (SPECT). Kajan ZD, Motevasseli S, Nasab NK, Ghanepour H, Abbaspur F. Aust Orthod J. 2006 Nov;22(2):127-30. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43368 |
Study title: Age-related normal variants of sternal uptake on bone scintigraphy.Kakhki VD, Zakavi SR. Clin Nucl Med. 2006 Feb;31(2):63-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43380 |
Study title: Kaneda K, Kurakami C, Minami A. Free vascularized fibular strut graft in the treatment of kyphosis. Spine. 1988 Nov;13(11):1273-7. Kaneda K, Kurakami C, Minami A. Free vascularized fibular strut graft in the treatment of kyphosis. Spine. 1988 Nov;13(11):1273-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43804 |
Study title: Kantarjian HM, Bledin AG, Kim EE, Gutierrez CR, Haynie TP. Uptake of 99mTc-methylene disphosphonate in calcinosis cutis. J Am Acad Dermatol. 1982 Dec;7(6):804-6. No abstract available. Kantarjian HM, Bledin AG, Kim EE, Gutierrez CR, Haynie TP. Uptake of 99mTc-methylene disphosphonate in calcinosis cutis. J Am Acad Dermatol. 1982 Dec;7(6):804-6. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44065 |
Study title: Safety and Immunogenicity of Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis (TdcP) Vaccine Compared to Tetanus and Diphtheria Toxoids Adsorbed (Td) in Adolescents and Adults 11-64 Years of Age |
Active substance: purif tetan toxoid,purif dipht toxoid,purif pert toxoid,purif filamentous haemaggl,purif fimbriae (agglutinogens 2 & 3),purif pertactin (69kda membrane protein)-inact polio vacc |
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Document reference: 41432 |
Study title: Safety of four acellular pertussis combination vaccines (Infantrix-IPV, Boostrix, Covaxis and repevax) given a booster dose to six-year-old Finnish children |
Active substance: purif tetan toxoid,purif dipht toxoid,purif pert toxoid,purif filamentous haemaggl,purif fimbriae (agglutinogens 2 & 3),purif pertactin (69kda membrane protein)-inact polio vacc |
Study summary document link (including results): |
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Document reference: 41433 |
Study title: Double blind, controlled trial testing the immunogenicity and side effects of parenteral Vi polysaccharide typhoid vaccine in Indonesian children and adults |
Active substance: Purified Vi capsular polysaccharide of Salmonella typhi (Ty2 strain) |
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Document reference: 21216 |
Study title: Effectiveness of a Vi capsular polysaccharide vaccine |
Active substance: Purified Vi capsular polysaccharide of Salmonella typhi (Ty2 strain) |
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Document reference: 41448 |
Study title: Safety and immunogenicity of Vi CPS vaccine in teenagers |
Active substance: Purified Vi capsular polysaccharide of Salmonella typhi (Ty2 strain) |
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Document reference: 21215 |
Study title: Fibrodysplasia ossificans progressiva: case report. Nucci A, Queiroz LD, Santos AD, Camargo EE, Moura-Ribeiro MV. Arq Neuropsiquiatr. 2000 Jun;58(2A):342-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43482 |
Study title: Nuti R, Vattimo A, Turchetti V, Righi G. 25-Hydroxycholecalciferol as an antagonist of adverse corticosteroid effects on phosphate and calcium metabolism in man. J Endocrinol Invest. 1984 Oct;7(5):445-8. Nuti R, Vattimo A, Turchetti V, Righi G. 25-Hydroxycholecalciferol as an antagonist of adverse corticosteroid effects on phosphate and calcium metabolism in man. J Endocrinol Invest. 1984 Oct;7(5):445-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43980 |
Study title: Herndon WA, Alexieva BT, Schwindt ML, Scott KN, Shaffer WO. Nuclear imaging for musculoskeletal infections in children. J Pediatr Orthop. 1985 May-Jun;5(3):343-7. Herndon WA, Alexieva BT, Schwindt ML, Scott KN, Shaffer WO. Nuclear imaging for musculoskeletal infections in children. J Pediatr Orthop. 1985 May-Jun;5(3):343-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43946 |
Study title: Herrera M, Silverman ED, Cole RL. Hepatic abscess detected on a three-phase bone scan. Clin Nucl Med. 2002 Apr;27(4):307-8. No abstract available. Herrera M, Silverman ED, Cole RL. Hepatic abscess detected on a three-phase bone scan. Clin Nucl Med. 2002 Apr;27(4):307-8. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43449 |
Study title: Hervás Benito I, González Cabezas P, Saura Quiles A, Pérez Velasco R, Bello Arques P, Mateo Navarro A. [Visualization of pulmonary metastasis of osteosarcoma with 99mTc-HMDP] Rev Esp Med Nucl. 2001 Dec;20(7):558-9. Spanish. No abstract available. Hervás Benito I, González Cabezas P, Saura Quiles A, Pérez Velasco R, Bello Arques P, Mateo Navarro A. [Visualization of pulmonary metastasis of osteosarcoma with 99mTc-HMDP] Rev Esp Med Nucl. 2001 Dec;20(7):558-9. Spanish. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43450 |
Study title: Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44220 |
Study title: Levine E, De Smet AA, Neff JR, Martin NL. Scintigraphic evaluation of giant cell tumor of bone. AJR Am J Roentgenol. 1984 Aug;143(2):343-8. Levine E, De Smet AA, Neff JR, Martin NL. Scintigraphic evaluation of giant cell tumor of bone. AJR Am J Roentgenol. 1984 Aug;143(2):343-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43991 |
Study title: A "harness" distribution pattern on pediatric Ga-67 scintigraphy. Lewis GW, Mansberg R, Howman-Giles R. Clin Nucl Med. 1999 Jul;24(7):527-8. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43505 |
Study title: [The application radionuclide bone imaging in the treatment of hallux valgus] Li W, Peng JJ, Zhou YX. Zhonghua Wai Ke Za Zhi. 1994 Dec;32(12):757-9. Chinese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43607 |
Study title: Lim ST, Sohn MH, Park SA. Tc-99m MDP three-phase bone scintigraphy in disciplinary exercise-induced rhabdomyolysis. Clin Nucl Med. 2000 Jul;25(7):558-9. No abstract available. Lim ST, Sohn MH, Park SA. Tc-99m MDP three-phase bone scintigraphy in disciplinary exercise-induced rhabdomyolysis. Clin Nucl Med. 2000 Jul;25(7):558-9. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43480 |
Study title: Lin D, Alavi A, Dalinka M. Bone scan evaluation of patellar activity. Int J Nucl Med Biol. 1981;8(1):105-9. No abstract available. Lin D, Alavi A, Dalinka M. Bone scan evaluation of patellar activity. Int J Nucl Med Biol. 1981;8(1):105-9. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44135 |
Study title: Lin D, Alavi A, Dalinka M. Scintigraphic evaluation of the hyoid bone and the thyroid--cricoid cartilage. Int J Nucl Med Biol. 1981;8(1):96-104. No abstract available. Lin D, Alavi A, Dalinka M. Scintigraphic evaluation of the hyoid bone and the thyroid--cricoid cartilage. Int J Nucl Med Biol. 1981;8(1):96-104. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44133 |
Study title: Open comparative trial to evaluate the effectiveness of gonorrhae in males.Fluker |
Active substance: AMOXICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_9.xlsx |
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Document reference: 48999 |
Study title: Open multicentre trial to evaluate the efficacy of amoxicllin in GP.Leigh et al |
Active substance: AMOXICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_10.xlsx |
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Document reference: 48996 |
Study title: Open parallell group to evalutate the efficacy for 2 different dose regimens for untreated maxillar sinuitis.Sydow et al. |
Active substance: AMOXICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_13.xlsx |
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Document reference: 48998 |
Study title: TO ASSESS THE EFFECT OF QUARTERLY TREATMENTS OVER A PERIOD OF ONE YEAR ON THE PREVALENCE OF ASCARIASIS, ANCYLOSTOMIASIS AND ENTEROBIASIS IN A RESIDENTIAL INSTITUTE FOR CHILDREN. |
Active substance: PYRANTEL PAMOATE |
Study summary document link (including results): |
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Document reference: 46151 |
Study title: TO ESTIMATE THE PERCENTAGE OF AT-RISK FAMILIES IN A HIGH-PREVALENCE AREA HAVING TWO OR MORE MEMBERS WITH ROUND-WORM HOOKWORM INFECTION. "AT-RISK" FAMILIES HAS ONE MEMBER INFECTED. "AFFECTED" FAMILIES HAS 2 OR MORE INFECTED MEMBERS. |
Active substance: PYRANTEL PAMOATE |
Study summary document link (including results): PRT-II-85-002 EMEA Pediatric Web Synopsis.pdf |
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Document reference: 46150 |
Study title: R.Ammer, Penka Demirova Drumeva, A.Völp: Nicht toxische Alternative zur Behandlung von Kopfläusen, päd (9) 2003 |
Active substance: Pyrethrum extract, Pyrethrins content 25% (m/m) (HERB) |
Study summary document link (including results): |
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Document reference: 40147 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Ranunculus-Homaccord (drops) [AWB-AT] |
Active substance: Ranunculus-Homaccord |
Study summary document link (including results): |
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Document reference: 40150 |
Study title: Hod N, Horne T. Interesting presentation of renal and adjacent rib infection on bone scintigraphy: the additive value of tissue phase images. Clin Nucl Med. 2004 Nov;29(11):720-2. No abstract available. Hod N, Horne T. Interesting presentation of renal and adjacent rib infection on bone scintigraphy: the additive value of tissue phase images. Clin Nucl Med. 2004 Nov;29(11):720-2. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43395 |
Study title: Hoefnagel CA, Bruning PF, Cohen P, Marcuse HR, van der Schoot JB. Detection of lung metastases from osteosarcoma by scintigraphy using 99mTc-methylene diphosphonate. Diagn Imaging. 1981;50(5):277-84. Hoefnagel CA, Bruning PF, Cohen P, Marcuse HR, van der Schoot JB. Detection of lung metastases from osteosarcoma by scintigraphy using 99mTc-methylene diphosphonate. Diagn Imaging. 1981;50(5):277-84. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44132 |
Study title: Due to the lack of good diagnostic techniques it can be difficult to diagnose asthma in young children. The symptoms can be such that anti-inflammatory medication is given as test medication; however there is a lack of clinical data in a large group of wheezy infants using objective endpoints. The aim of this study was to evaluate the effects of fluticasone propionate on lung function and symptom scores in infants with recurrent and persistent wheeze. |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FMS30060-ICHE3.pdf |
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Document reference: 28398 |
Study title: Lin DS, Alavi A. Bone scan evaluation of degenerative joint disease of the spine. Int J Nucl Med Biol. 1982;9(1):63-4. No abstract available. Lin DS, Alavi A. Bone scan evaluation of degenerative joint disease of the spine. Int J Nucl Med Biol. 1982;9(1):63-4. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44104 |
Study title: Evaluation of arthritis in Reiter's disease by bone scintigraphy and radiography. Lin WY, Wang SJ, Lan JL. Clin Rheumatol. 1995 Jul;14(4):441-4. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43596 |
Study title: Lin WY, Wang SJ, Lang JL, Hsu CY, Kao CH, Liao SQ, Yeh HW. Bone scintigraphy in evaluation of heel pain in Reiter's disease: compared with radiography and clinical examination. Scand J Rheumatol. 1995;24(1):18-21. Lin WY, Wang SJ, Lang JL, Hsu CY, Kao CH, Liao SQ, Yeh HW. Bone scintigraphy in evaluation of heel pain in Reiter's disease: compared with radiography and clinical examination. Scand J Rheumatol. 1995;24(1):18-21. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43605 |
Study title: Papanicolaou N. Osteoid osteoma: operative confirmation of complete removal by bone scintigraphy. Radiology. 1985 Mar;154(3):821-2. Papanicolaou N. Osteoid osteoma: operative confirmation of complete removal by bone scintigraphy. Radiology. 1985 Mar;154(3):821-2. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43957 |
Study title: Paramsothy M, Peng LH, Samuel D. Diagnostic value of radionuclide technetium 99m-MDP skeletal survey in acute leukaemia. Australas Radiol. 1983 Nov;27(3):295-6. No abstract available. Paramsothy M, Peng LH, Samuel D. Diagnostic value of radionuclide technetium 99m-MDP skeletal survey in acute leukaemia. Australas Radiol. 1983 Nov;27(3):295-6. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44023 |
Study title: Park CH, Kapadia D, O'Hara AE. Three phase bone scan findings in stress fracture. Clin Nucl Med. 1981 Dec;6(12):587-8. No abstract available. Park CH, Kapadia D, O'Hara AE. Three phase bone scan findings in stress fracture. Clin Nucl Med. 1981 Dec;6(12):587-8. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44106 |
Study title: Park HM, Hunt-Reimann A, Appledorn CR, Siddiqui A. A comet-tail imaging artifact. Due to a "hot" point source and faulty electronics. Clin Nucl Med. 1993 Apr;18(4):341-2. No abstract available. Park HM, Hunt-Reimann A, Appledorn CR, Siddiqui A. A comet-tail imaging artifact. Due to a "hot" point source and faulty electronics. Clin Nucl Med. 1993 Apr;18(4):341-2. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43669 |
Study title: Scintigraphic evaluation of extremity pain in children: its efficacy and pitfalls. Park HM, Rothschild PA, Kernek CB. AJR Am J Roentgenol. 1985 Nov;145(5):1079-84. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43930 |
Study title: Open pilot study to evaluate different dosages in various infections.Murdoch |
Active substance: AMOXICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_8.xlsx |
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Document reference: 48997 |
Study title: Open single centertrial to evaluate efficacy and safety of amoxicillin for treatment of UTIParsons et al |
Active substance: AMOXICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Amoxillin_11.xlsx |
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Document reference: 48995 |
Study title: Role of bone scans in assessment of skeletal age. Spencer RP, Sami S, Karimeddini M, Sziklas JJ, Rosenberg R. Int J Nucl Med Biol. 1981;8(1):33-8. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44134 |
Study title: Knop J, Delling G, Heise U, Winkler K. Parametric imaging of 99mTc methylene diphosphonate biokinetics in osteosarcoma for preoperative evaluation of chemotherapy-induced necrosis. Chir Organi Mov. 1990;75(1 Suppl):36-7. No abstract available. Knop J, Delling G, Heise U, Winkler K. Parametric imaging of 99mTc methylene diphosphonate biokinetics in osteosarcoma for preoperative evaluation of chemotherapy-induced necrosis. Chir Organi Mov. 1990;75(1 Suppl):36-7. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43773 |
Study title: Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43774 |
Study title: Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44176 |
Study title: Takebayashi S, Ono Y, Matsui K. [The changes in renal uptake of 99mTc-MDP after radiotherapy in the neuroblastoma (author's transl)] Kaku Igaku. 1981 Jul;18(6):859-62. Japanese. No abstract available. Takebayashi S, Ono Y, Matsui K. [The changes in renal uptake of 99mTc-MDP after radiotherapy in the neuroblastoma (author's transl)] Kaku Igaku. 1981 Jul;18(6):859-62. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44120 |
Study title: Battered child syndrome. Uncommon pelvic fractures detected by bone scintigraphy. Tan TX, Gelfand MJ. Clin Nucl Med. 1997 May;22(5):321-2. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43552 |
Study title: [Algodystrophy, a little known disease in children. General review apropos of 4 cases] French. Labenne M, Bertrand AM, Wendling D, Onimus M, Laurain JM, Amsallem D. Ann Pediatr (Paris). 1987 Oct;34(8):603-8. Review. French. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43850 |
Study title: Lamki L, Willis RB. Radionuclide findings of pyomyositis. Clin Nucl Med. 1982 Oct;7(10):465-7. No abstract available. Lamki L, Willis RB. Radionuclide findings of pyomyositis. Clin Nucl Med. 1982 Oct;7(10):465-7. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44073 |
Study title: Efficacy of treatment with inhaled fluticasone and the effect of priming and activation of PMN cells in children with allergy and asthma. |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-Propionate-FMS40229-ICHE3.pdf |
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Document reference: 28405 |
Study title: A 12-week randomized, multicenter, double-blind, placebo controlled, parallel group study in children (aged 5-12, inclusive) with persistent asthma evaluating the safety, efficacy and pharmacokinetics of Foradil (formoterol fumarate) 10 mg bid delivered b |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 0604 Art45 listing 2011.xls |
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Document reference: 47797 |
Study title: Paulus G, Hirschfelder U, Feistel H. [Computer-assisted quantitative bone scintigraphy in the treatment planning of condylar hyperplasia] Fortschr Kiefer Gesichtschir. 1987;32:180-1. German. No abstract available. Paulus G, Hirschfelder U, Feistel H. [Computer-assisted quantitative bone scintigraphy in the treatment planning of condylar hyperplasia] Fortschr Kiefer Gesichtschir. 1987;32:180-1. German. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43884 |
Study title: Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44118 |
Study title: Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44238 |
Study title: Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. Ishii C, Mori Y, Hata Y, Katsuyama N, Fujioka M, Fukazawa W, Hashimoto H, Horiuchi T, Fujioka M, Kawakami K. [Clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Radioisotopes. 1981 Jul;30(7):401-3. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44285 |
Study title: Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44086 |
Study title: Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44187 |
Study title: Parker BR. Neuroblastoma with extraosseous uptake of bone-seeking radionuclide. AJR Am J Roentgenol. 1981 May;136(5):1032-4. No abstract available. Parker BR. Neuroblastoma with extraosseous uptake of bone-seeking radionuclide. AJR Am J Roentgenol. 1981 May;136(5):1032-4. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44124 |
Study title: Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 44223 |
Study title: Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. Knop J, Delling G, Heise U, Winkler K. Scintigraphic evaluation of tumor regression during preoperative chemotherapy of osteosarcoma. Correlation of 99mTc-methylene diphosphonate parametric imaging with surgical histopathology. Skeletal Radiol. 1990;19(3):165-72. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44270 |
Study title: Minoves M, Bassa P, Clemente A, Rivas A, Riera E, Setoain J, Costansa JM. Incidental finding of varicocele detected on a blood-pool image on Tc-99m HMDP bone scintigraphy. Clin Nucl Med. 2000 Nov;25(11):947-8. No abstract available. Minoves M, Bassa P, Clemente A, Rivas A, Riera E, Setoain J, Costansa JM. Incidental finding of varicocele detected on a blood-pool image on Tc-99m HMDP bone scintigraphy. Clin Nucl Med. 2000 Nov;25(11):947-8. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43472 |
Study title: The value of quantitative sacroiliac scintigraphy in detection of sacroiliitis. Miron SD, Khan MA, Wiesen EJ, Kushner I, Bellon EM. Clin Rheumatol. 1983 Dec;2(4):407-14. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44020 |
Study title: Mondal A, Bhatnagar A, Sharma R, Behari V, Sawroop K, Khanna CM. Evaluation of the healing process in fractures using early and delayed bone scanning. Australas Radiol. 1994 Nov;38(4):284-7. Mondal A, Bhatnagar A, Sharma R, Behari V, Sawroop K, Khanna CM. Evaluation of the healing process in fractures using early and delayed bone scanning. Australas Radiol. 1994 Nov;38(4):284-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43608 |
Study title: Single-blind trial to evaluate the efficacy and safety of ampicillin suppositories in bacterial pneumonia in children using i.v. ampicillin as reference drug.Motohiro et al. (1983-05-09) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_21.xlsx |
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Document reference: 49020 |
Study title: Lammer J, Nicoletti R, Fueger GF, Fink W. Osteoscintimetry--a method of semiquantitative evaluation of skeletal scintigrams by use of profiles and a macro function for computer processing. Eur J Nucl Med. 1982;7(8):364-9. Lammer J, Nicoletti R, Fueger GF, Fink W. Osteoscintimetry--a method of semiquantitative evaluation of skeletal scintigrams by use of profiles and a macro function for computer processing. Eur J Nucl Med. 1982;7(8):364-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44099 |
Study title: Oh SN, Jee WH, Cho SM, Kim SH, Kang HS, Ryu KN, Cho CS. Osteonecrosis in patients with systemic lupus erythematosus: MR imaging and scintigraphic evaluation. Clin Imaging. 2004 Jul-Aug;28(4):305-9. Oh SN, Jee WH, Cho SM, Kim SH, Kang HS, Ryu KN, Cho CS. Osteonecrosis in patients with systemic lupus erythematosus: MR imaging and scintigraphic evaluation. Clin Imaging. 2004 Jul-Aug;28(4):305-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43400 |
Study title: A 3-week, open-label, uncontrolled, multicenter study evaluating the functionality of the Foradil Certihaler device in patients with Asthma. |
Active substance: FORMOTEROL |
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Document reference: 47801 |
Study title: A randomized, multi-centre, double-blind, double-dummy placebo controlled single-dose cross-over study to demonstrate that 12 and 24 mg of formoterol delivered by concept1 has a bronchodilator efficacy which is equivalent to the same dose of formoterol de |
Active substance: FORMOTEROL |
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Document reference: 47811 |
Study title: A randomized, multicenter, double-blind, double-dummy, placebo controlled, cross-over dose ranging study to evaluate the safety and efficacy of single doses of formoterol fumarate (6,12 and 24 ug) via an hfa pmdi versus placebo and versus formoterol fumar |
Active substance: FORMOTEROL |
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Document reference: 47809 |
Study title: Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44234 |
Study title: Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. Ishine M, Kawamura M, Koizumi M, Itoh H, Murase K, Inatsuki S, Iio A, Hamamoto K. [Basic and clinical studies of 99mTc-hydroxymethylene diphosphonate for skeletal imaging agent] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 Apr 25;42(4):389-97. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44281 |
Study title: Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. Uren RF, Howman-Giles R. The 'cold hip' sign on bone scan. A retrospective review. Clin Nucl Med. 1991 Aug;16(8):553-6. PMID: 1934806 [PubMed - indexed for MEDLINE] 372: Caner BE, Ercan MT, Bekdik CF, Varoğlu E, Müezzinoğlu S, Duman Y, Erbengi GF. Visualization of bone pathologies and lung cancer with 99mTc-glucose phosphate: a comparative study. Nuklearmedizin. 1991 Aug;30(4):132-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44267 |
Study title: Urman M, Ammann W, Sisler J, Lentle BC, Llyod-Smith R, Loomer R, Fisher C. The role of bone scintigraphy in the evaluation of talar dome fractures. J Nucl Med. 1991 Dec;32(12):2241-4. Urman M, Ammann W, Sisler J, Lentle BC, Llyod-Smith R, Loomer R, Fisher C. The role of bone scintigraphy in the evaluation of talar dome fractures. J Nucl Med. 1991 Dec;32(12):2241-4. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43720 |
Study title: Usui K, Yamamoto W, Shuke N, Aburano T, Yamanaka Y, Tokusashi Y, Miyokawa N. Scintigraphic findings of tibial adamantinoma on a three-phase bone scan. Clin Nucl Med. 2000 Dec;25(12):1057-8. No abstract available. Usui K, Yamamoto W, Shuke N, Aburano T, Yamanaka Y, Tokusashi Y, Miyokawa N. Scintigraphic findings of tibial adamantinoma on a three-phase bone scan. Clin Nucl Med. 2000 Dec;25(12):1057-8. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43467 |
Study title: Vade A, Jeske J. Infiltrating lipoma of the chest wall. Pediatr Radiol. 1993;23(6):469-70. No abstract available. Vade A, Jeske J. Infiltrating lipoma of the chest wall. Pediatr Radiol. 1993;23(6):469-70. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43679 |
Study title: Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44237 |
Study title: Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. Hamada S, Miyamura T, Okimura T, Yamamoto T, Nishiki M, Miyatani H, Kobayashi M, Tonami H, Takarada A, Yamagishi T, Higashi K, Chatani T. [A case of melorheostosis-correlation with sclerotome map and bone scan image (author's transl)] Rinsho Hoshasen. 1981 Aug 26;26(8):897-900. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44284 |
Study title: Age-related changes in the hemodynamics of the femoral head as evaluated by early phase of bone scintigraphy. Hamaguchi H, Fujioka M, Takahashi KA, Hirata T, Ishida M, Sakao K, Ushijima Y, Kubota T, Nishimura T, Kubo T. Ann Nucl Med. 2006 Jan;20(1):35-40. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43378 |
Study title: Ohta H, Hojo M, Shintaku M, Komibuchi T, Okamoto S. Tc-99m HMDP and Ga-67 imaging along with CT and MRI in fibrous dysplasia of the temporal bone. Clin Nucl Med. 1997 May;22(5):328-30. No abstract available. Ohta H, Hojo M, Shintaku M, Komibuchi T, Okamoto S. Tc-99m HMDP and Ga-67 imaging along with CT and MRI in fibrous dysplasia of the temporal bone. Clin Nucl Med. 1997 May;22(5):328-30. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43551 |
Study title: Okimura T, Higashi K, Nakagawa T, Kobayashi S, Tohda N. [A case of myositis ossificans with abnormal uptake of 99mTc-MDP and 67Ga-citrate] Rinsho Hoshasen. 1985 Jan;30(1):157-9. Japanese. No abstract available. Okimura T, Higashi K, Nakagawa T, Kobayashi S, Tohda N. [A case of myositis ossificans with abnormal uptake of 99mTc-MDP and 67Ga-citrate] Rinsho Hoshasen. 1985 Jan;30(1):157-9. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43968 |
Study title: Okuyama T, Suzuki H, Nakamoto K, Suzuki S. [Evaluation of bone scintigraphy in differential diagnosis of benign bone tumors] Kaku Igaku. 1982 Dec;19(10):1519-30. Japanese. No abstract available. Okuyama T, Suzuki H, Nakamoto K, Suzuki S. [Evaluation of bone scintigraphy in differential diagnosis of benign bone tumors] Kaku Igaku. 1982 Dec;19(10):1519-30. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44063 |
Study title: Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44107 |
Study title: Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44188 |
Study title: Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44235 |
Study title: Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. Honda H, Oshiumi Y, Kamoi I, Ichiya Y, Wada M, Matsuura K. [Clinical evaluation of 99mTc-hydroxymethylene diphosphonate (HMDP) bone scintigraphy: comparison with 99mTc-MDP (author's transl)] Kaku Igaku. 1981 Nov;18(9):1315-9. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44282 |
Study title: Van Campenhout A, Moens P, Fabry G. Serial bone scintigraphy in Legg-Calvé-Perthes disease: correlation with the Catterall and Herring classification. J Pediatr Orthop B. 2006 Jan;15(1):6-10. Van Campenhout A, Moens P, Fabry G. Serial bone scintigraphy in Legg-Calvé-Perthes disease: correlation with the Catterall and Herring classification. J Pediatr Orthop B. 2006 Jan;15(1):6-10. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43382 |
Study title: van den Oever M, Merrick MV, Scott JH. Bone scintigraphy in symptomatic spondylolysis. J Bone Joint Surg Br. 1987 May;69(3):453-6. van den Oever M, Merrick MV, Scott JH. Bone scintigraphy in symptomatic spondylolysis. J Bone Joint Surg Br. 1987 May;69(3):453-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43865 |
Study title: Generalized soft tissue calcification in children and adolescents with end stage renal failure. van Diemen-Steenvoorde R, Donckerwolcke RA, de Haas G. Eur J Pediatr. 1986 Sep;145(4):293-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43893 |
Study title: Liu JX. [Early quantitative detection of vascularity of the reduced femoral head of congenital hip dislocation by scintigraphy] Zhonghua Wai Ke Za Zhi. 1990 May;28(5):292-4, 318. Chinese. Liu JX. [Early quantitative detection of vascularity of the reduced femoral head of congenital hip dislocation by scintigraphy] Zhonghua Wai Ke Za Zhi. 1990 May;28(5):292-4, 318. Chinese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43764 |
Study title: Primary septic arthritis in heroin users: early diagnosis by radioisotopic imaging and geographic variations in the causative agents. Lopez-Longo FJ, Ménard HA, Carreño L, Cosin J, Ballesteros R, Monteagudo I. J Rheumatol. 1987 Oct;14(5):991-4. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43846 |
Study title: A double blind trial to evaluate the incidence of diarrhea and C. difficile toxin (CDT) folloing therapy with ampicillin (AMP), amoxicillin (AMOX), or trimethoprim-sulfamethoxazole (TMP-SMX) for otitis media.Hyams et al. (Pediatr Infect Dis. 1984 Sep-Oct;3(5):433-6) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_30.xlsx |
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Document reference: 49029 |
Study title: Hamscho N, Grünwald F. Prognosis of primary osteosarcoma. J Nucl Med. 2003 Jun;44(6):996-7; author reply 997. No abstract available. Hamscho N, Grünwald F. Prognosis of primary osteosarcoma. J Nucl Med. 2003 Jun;44(6):996-7; author reply 997. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43420 |
Study title: Han CS, Wood MB, Bishop AT, Cooney WP 3rd. Vascularized bone transfer. J Bone Joint Surg Am. 1992 Dec;74(10):1441-9. Han CS, Wood MB, Bishop AT, Cooney WP 3rd. Vascularized bone transfer. J Bone Joint Surg Am. 1992 Dec;74(10):1441-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43681 |
Study title: Spitz J, Becker C, Tittel K, Weigand H. [Clinical relevance of whole body skeletal scintigraphy in multiple injury and polytrauma patients] Unfallchirurgie. 1992 Jun;18(3):133-47. German. Spitz J, Becker C, Tittel K, Weigand H. [Clinical relevance of whole body skeletal scintigraphy in multiple injury and polytrauma patients] Unfallchirurgie. 1992 Jun;18(3):133-47. German. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43695 |
Study title: Spitz J, Lauer I, Tittel K, Wiegand H. Scintimetric evaluation of remodeling after bone fractures in man. J Nucl Med. 1993 Sep;34(9):1403-9. Spitz J, Lauer I, Tittel K, Wiegand H. Scintimetric evaluation of remodeling after bone fractures in man. J Nucl Med. 1993 Sep;34(9):1403-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43654 |
Study title: Horne T, Mogle P, Finsterbush A, Gordin M. Increased uptake of 99mTc-MDP in calcified synovial sarcoma. Eur J Nucl Med. 1983;8(2):75-6. No abstract available. Horne T, Mogle P, Finsterbush A, Gordin M. Increased uptake of 99mTc-MDP in calcified synovial sarcoma. Eur J Nucl Med. 1983;8(2):75-6. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44054 |
Study title: The technetium phosphate bone scan in the diagnosis of osteomyelitis in childhood. Howie DW, Savage JP, Wilson TG, Paterson D. J Bone Joint Surg Am. 1983 Apr;65(4):431-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44041 |
Study title: Teixeira AB, Sá de Camargo Etchebehere EC, Santos AO, Lima MC, Ramos CD, Camargo EE. Scintigraphic findings of dysplasia epiphysealis hemimelica: a case report. Clin Nucl Med. 2001 Feb;26(2):162. No abstract available. Teixeira AB, Sá de Camargo Etchebehere EC, Santos AO, Lima MC, Ramos CD, Camargo EE. Scintigraphic findings of dysplasia epiphysealis hemimelica: a case report. Clin Nucl Med. 2001 Feb;26(2):162. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43460 |
Study title: Rectus femoris muscle bone-image uptake in a sprinter. Telepak RJ, Hartshorne MF, Bauman JM, Cawthon MA. Clin Nucl Med. 1986 May;11(5):365. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43911 |
Study title: Thämmig R, Schulze K, Niederle J. [Display of a primary neuroblastoma in the bone scintigram] Rofo. 1981 Aug;135(2):239-40. German. No abstract available. Thämmig R, Schulze K, Niederle J. [Display of a primary neuroblastoma in the bone scintigram] Rofo. 1981 Aug;135(2):239-40. German. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44116 |
Study title: Lucchi A, Tani G, Mancini AM, Rossi C, Mancuso A, De Florio L. [Morphologic and scintigraphic correlations in the cranial localization of neuroblastoma. Study of 29 cases] Radiol Med (Torino). 1984 Sep;70(9):639-40. Italian. No abstract available. Lucchi A, Tani G, Mancini AM, Rossi C, Mancuso A, De Florio L. [Morphologic and scintigraphic correlations in the cranial localization of neuroblastoma. Study of 29 cases] Radiol Med (Torino). 1984 Sep;70(9):639-40. Italian. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43983 |
Study title: Clinical impact and prognostic value of metaiodobenzylguanidine imaging in children with metastatic neuroblastoma. Perel Y, Conway J, Kletzel M, Goldman J, Weiss S, Feyler A, Cohn SL. J Pediatr Hematol Oncol. 1999 Jan-Feb;21(1):13-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43514 |
Study title: Pevarski DJ, Drane WE, Scarborough MT. The usefulness of bone scintigraphy with SPECT images for detection of pulmonary metastases from osteosarcoma. AJR Am J Roentgenol. 1998 Feb;170(2):319-22. Pevarski DJ, Drane WE, Scarborough MT. The usefulness of bone scintigraphy with SPECT images for detection of pulmonary metastases from osteosarcoma. AJR Am J Roentgenol. 1998 Feb;170(2):319-22. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43537 |
Study title: Phillips CD, Williamson BR. Osteosarcoma with pericardial metastases seen on bone scan. Clin Nucl Med. 1987 Nov;12(11):899-900. No abstract available. Phillips CD, Williamson BR. Osteosarcoma with pericardial metastases seen on bone scan. Clin Nucl Med. 1987 Nov;12(11):899-900. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43841 |
Study title: A Single-blind, randomized trial to Evaluate the efficacy and safety of ampicillin suppositories in the treatment of acute suppurative otitis media by a well controlled method using ampicillin dry syrup as control.Baba et al. (1985-09-27) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_20.xlsx |
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Document reference: 49019 |
Study title: Stauss J, Connolly LP, Perez-Rossello J, Treves ST. Pediatric acute pyelonephritis: diagnosis facilitated by skeletal scintigraphy. Clin Nucl Med. 2003 Oct;28(10):855-7. No abstract available. Stauss J, Connolly LP, Perez-Rossello J, Treves ST. Pediatric acute pyelonephritis: diagnosis facilitated by skeletal scintigraphy. Clin Nucl Med. 2003 Oct;28(10):855-7. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43413 |
Study title: Kobayashi Y, Ozaki T, Takeda Y, Kawai A, Inoue H. Evaluation of the effect of preoperative chemotherapy in bone sarcomas. 99mTc-HMDP scintigraphy in 34 cases. Acta Orthop Scand. 1998 Dec;69(6):611-6. Kobayashi Y, Ozaki T, Takeda Y, Kawai A, Inoue H. Evaluation of the effect of preoperative chemotherapy in bone sarcomas. 99mTc-HMDP scintigraphy in 34 cases. Acta Orthop Scand. 1998 Dec;69(6):611-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43519 |
Study title: Koppers B, Riel K. [3-phase scintigraphy in epicondylitis humeri radialis] Rofo. 1982 Aug;137(2):147-51. German. No abstract available. Koppers B, Riel K. [3-phase scintigraphy in epicondylitis humeri radialis] Rofo. 1982 Aug;137(2):147-51. German. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44077 |
Study title: The diagnostic importance of a quantitative evaluation of gamma scintigraphy in Perthes' disease in children.Dmitrienkov BN, Fed in AV, Zhvaniia TG, Subbotina EN. Med Radiol1989 Jul;34(7):19-23. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48477 |
Study title: [The early diagnosis of Perthes disease: the value of bone scintigraphy and magnetic resonance imaging in comparison with x-ray findings] German. Theissen P, Rütt J, Linden A, Smolarz K, Voth E, Schicha H. Nuklearmedizin. 1991 Dec;30(6):265-71. German. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43717 |
Study title: Thomas BP, Spottswood SE, Wushensky CA. The hot spur sign of diastematomyelia. Clin Nucl Med. 2007 Apr;32(4):292-4. No abstract available. Thomas BP, Spottswood SE, Wushensky CA. The hot spur sign of diastematomyelia. Clin Nucl Med. 2007 Apr;32(4):292-4. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43364 |
Study title: Tiel-van Buul MM, van Beek EJ, Broekhuizen AH, Bakker AJ, Bos KE, van Royen EA. Radiography and scintigraphy of suspected scaphoid fracture. A long-term study in 160 patients. J Bone Joint Surg Br. 1993 Jan;75(1):61-5. Tiel-van Buul MM, van Beek EJ, Broekhuizen AH, Bakker AJ, Bos KE, van Royen EA. Radiography and scintigraphy of suspected scaphoid fracture. A long-term study in 160 patients. J Bone Joint Surg Br. 1993 Jan;75(1):61-5. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43677 |
Study title: Routine bone scintigraphy is of limited value in the clinical assessment of untreated patients with Hodgkin's disease. Landgren O, Axdorph U, Jacobsson H, Johansson B, Grimfors G, Björkholm M. Med Oncol. 2000 Aug;17(3):174-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43478 |
Study title: Lange RH, Lange TA, Rao BK. Correlative radiographic, scintigraphic, and histological evaluation of exostoses. J Bone Joint Surg Am. 1984 Dec;66(9):1454-9. Lange RH, Lange TA, Rao BK. Correlative radiographic, scintigraphic, and histological evaluation of exostoses. J Bone Joint Surg Am. 1984 Dec;66(9):1454-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43975 |
Study title: Lange W, Wicke A, Stern W, Staudte H. [Osteoid osteoma of the spine. The current differential diagnostic aspects] Rofo. 1991 Apr;154(4):450-2. German. No abstract available. Lange W, Wicke A, Stern W, Staudte H. [Osteoid osteoma of the spine. The current differential diagnostic aspects] Rofo. 1991 Apr;154(4):450-2. German. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43743 |
Study title: Extremity osteosarcoma in childhood: prognostic value of radiologic imaging. Lawrence JA, Babyn PS, Chan HS, Thorner PS, Pron GE, Krajbich IJ. Radiology. 1993 Oct;189(1):43-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43647 |
Study title: Technetium 99m-methylene diphosphonate bone scans in children with reflex neurovascular dystrophy. Laxer RM, Allen RC, Malleson PN, Morrison RT, Petty RE. J Pediatr. 1985 Mar;106(3):437-40. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43956 |
Study title: A Randomized, Double-Blind, 12-Week Trial Evaluating the Safety of the Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Symptomatic Pediatric Subjects (4-11 Years) With Asthma |
Active substance: FLUTICASONE AND SALMETEROL |
Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAS30031-ICHE3.pdf |
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Document reference: 28453 |
Study title: An observational study to assess the health related quality of life impact of treating poorly controlled asthmatic children with Seretide(tm) 50/100mcg |
Active substance: FLUTICASONE AND SALMETEROL |
Study summary document link (including results): Fluticasone-Propionate-Sameterol-SAM3802-ICHE3.pdf |
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Document reference: 28442 |
Study title: Prospective, parallel-group, randomized, open label study to evaluate the impact of additional guidance from the health professionals team on treatment compliance of children aged between 6 and 14 years old with persistent moderate or severe asthma, receiving the combination salmeterol/fluticasone propionate 50/250 mcg (Seretide) twice a day. ADERE PROJECT (Pediatric) |
Active substance: FLUTICASONE AND SALMETEROL |
Study summary document link (including results): Fluticasone-Propionate-Sameterol-ADERE-PEDIATRIC-1-ICHE3.pdf |
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Document reference: 28444 |
Study title: Routine bone scintigraphy in primary staging of soft tissue sarcoma; Is it worthwhile? Jager PL, Hoekstra HJ, Leeuw J, van Der Graaf WT, de Vries EG, Piers D. Cancer. 2000 Oct 15;89(8):1726-31. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43475 |
Study title: Bone scan in diagnosis of lymphoma with extensive bone marrow necrosis--a case report. Jain D, Pattari S, Rajesh LS, Varma N, Mittal BR. Indian J Pathol Microbiol. 2004 Jul;47(3):394-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43381 |
Study title: A Single-blinded, Randomized trial to evaluate the efficacy and safety of 125 mg ampicillin suppositories in the treatment of acute respiratory tract infections in pediatric patients using ampicillin dry syrup as control.Nishimura et al. (1983-05-04) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_22.xlsx |
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Document reference: 49021 |
Study title: [Early diagnosis of bone infarction in children with sickle cell anemia by MDP 99m Tc scanning] Koren A, Fedchteyn S, Katsuni E. Harefuah. 1982 Mar 1;102(5):182-5. Hebrew. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44090 |
Study title: Koren A, Garty I, Ben-Ami M, Katzuni E. Uncommon orbital bone infarctions in a sickle cell anemia patient. Clin Nucl Med. 1984 Dec;9(12):721-2. No abstract available. Koren A, Garty I, Ben-Ami M, Katzuni E. Uncommon orbital bone infarctions in a sickle cell anemia patient. Clin Nucl Med. 1984 Dec;9(12):721-2. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43973 |
Study title: Murray IP, Ford JC. Tc-99m medronate scintigraphy in mandibular condylar hyperplasia. Clin Nucl Med. 1982 Oct;7(10):474-5. No abstract available. Murray IP, Ford JC. Tc-99m medronate scintigraphy in mandibular condylar hyperplasia. Clin Nucl Med. 1982 Oct;7(10):474-5. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44072 |
Study title: Leckie RG, Watabe JT, Shanley DJ, Werner M. Tc-99m HDP bone scintigraphy of ameloblastoma with panorex, CT, MRI, and gross correlation. Clin Nucl Med. 1993 Apr;18(4):350-2. No abstract available. Leckie RG, Watabe JT, Shanley DJ, Werner M. Tc-99m HDP bone scintigraphy of ameloblastoma with panorex, CT, MRI, and gross correlation. Clin Nucl Med. 1993 Apr;18(4):350-2. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43668 |
Study title: Lee BE, Robinson JL. The use of technetium-99m-labeled white blood cell scan in the management of a case of group A streptococcus necrotizing fasciitis with polymyositis. Clin Infect Dis. 1999 Jan;28(1):153-4. No abstract available. Lee BE, Robinson JL. The use of technetium-99m-labeled white blood cell scan in the management of a case of group A streptococcus necrotizing fasciitis with polymyositis. Clin Infect Dis. 1999 Jan;28(1):153-4. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43515 |
Study title: Ongolo-Zogo P, Thiesse P, Sau J, Desuzinges C, Blay JY, Bonmartin A, Bochu M, Philip T. Assessment of osteosarcoma response to neoadjuvant chemotherapy: comparative usefulness of dynamic gadolinium-enhanced spin-echo magnetic resonance imaging and technetium-99m skeletal angioscintigraphy. Eur Radiol. 1999;9(5):907-14. Ongolo-Zogo P, Thiesse P, Sau J, Desuzinges C, Blay JY, Bonmartin A, Bochu M, Philip T. Assessment of osteosarcoma response to neoadjuvant chemotherapy: comparative usefulness of dynamic gadolinium-enhanced spin-echo magnetic resonance imaging and technetium-99m skeletal angioscintigraphy. Eur Radiol. 1999;9(5):907-14. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43506 |
Study title: Tc-99m MDP uptake secondary to soft tissue extravasation of calcium gluconate in a newborn thought to have osteomyelitis. Orellana P, Velasquez C, Meneses L, Urioste A, Carreño JE, Garcíia CJ, Sabroso F, Cruces P. Clin Nucl Med. 2002 Sep;27(9):653-5. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44246 |
Study title: A randomized, multicenter, placebo-controlled parallel group study of four months duration per patient to evaluate the safety and efficacy of treatment with 24 µg b.i.d. and 12 µg b.i.d. formoterol, double-blind, and 12 µg b.i.d. formoterol with additio |
Active substance: FORMOTEROL |
Study summary document link (including results): |
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Document reference: 47810 |
Study title: A single dose study evaluating peak inspiratory flow rate and forced inspiratory vital capacity in children and adults with asthma of differing severity after administration of a placebo capsule for inhalation when using the aerolizer device |
Active substance: FORMOTEROL |
Study summary document link (including results): FOR258 0061 Art45 listing 2011.xls |
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Document reference: 47813 |
Study title: Jánoskuti L, Szilvási I, Papp G, Róna E, Benedek S, Fekete S. Bone scanning and radiography in the evaluation of patients with malignant lymphoma. Rofo. 1988 Oct;149(4):427-8. Jánoskuti L, Szilvási I, Papp G, Róna E, Benedek S, Fekete S. Bone scanning and radiography in the evaluation of patients with malignant lymphoma. Rofo. 1988 Oct;149(4):427-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43808 |
Study title: Vattimo A, Martini G, Pisani M. Bone uptake of 99mTc-MDP in man: its relationship with local blood flow. J Nucl Med Allied Sci. 1982 Jul-Sep;26(3):173-9. No abstract available. Vattimo A, Martini G, Pisani M. Bone uptake of 99mTc-MDP in man: its relationship with local blood flow. J Nucl Med Allied Sci. 1982 Jul-Sep;26(3):173-9. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44185 |
Study title: Vattimo A, Martini G, Pisani M. Bone uptake of 99mTc-MDP in man: its relationship with local blood flow. J Nucl Med Allied Sci. 1982 Jul-Sep;26(3):173-9. No abstract available. Vattimo A, Martini G, Pisani M. Bone uptake of 99mTc-MDP in man: its relationship with local blood flow. J Nucl Med Allied Sci. 1982 Jul-Sep;26(3):173-9. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44232 |
Study title: Vattimo A, Martini G, Pisani M. Bone uptake of 99mTc-MDP in man: its relationship with local blood flow. J Nucl Med Allied Sci. 1982 Jul-Sep;26(3):173-9. No abstract available. Vattimo A, Martini G, Pisani M. Bone uptake of 99mTc-MDP in man: its relationship with local blood flow. J Nucl Med Allied Sci. 1982 Jul-Sep;26(3):173-9. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44279 |
Study title: Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44141 |
Study title: Murray IP, Rossleigh MA, Dixon J. Clin Nucl Med. 1995 Jun;20(6):560-1. No abstract available. Murray IP, Rossleigh MA, Dixon J. Clin Nucl Med. 1995 Jun;20(6):560-1. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43599 |
Study title: [Osteoscintigraphy in the evaluation of a bone transplant in cranioplasty in children] Russian. Mytnikov AM, Smirnov IuN, Ivanov LB, Eshankulov GS, Bukhanov VE. Med Radiol (Mosk). 1989 Apr;34(4):46-9. Russian. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43790 |
Study title: Han JS, Kim YG, Kim S, Lee MC, Lee JS, Kim SH. Bone scintigraphy in acute renal failure with severe loin pain and patchy renal vasoconstriction. Nephron. 1991;59(2):254-60. Han JS, Kim YG, Kim S, Lee MC, Lee JS, Kim SH. Bone scintigraphy in acute renal failure with severe loin pain and patchy renal vasoconstriction. Nephron. 1991;59(2):254-60. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43750 |
Study title: Hanash KA, Bissada NK, Abla A, Esmail D, Dowling A. Predictive value of excretory urography, ultrasonography, computerized tomography, and liver and bone scan in the staging of bilharzial bladder cancer in Saudi Arabia. Cancer. 1984 Jul 1;54(1):172-6. Hanash KA, Bissada NK, Abla A, Esmail D, Dowling A. Predictive value of excretory urography, ultrasonography, computerized tomography, and liver and bone scan in the staging of bilharzial bladder cancer in Saudi Arabia. Cancer. 1984 Jul 1;54(1):172-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43993 |
Study title: Angular deformity of the lower extremity: evaluation with quantitative bone scintigraphy. Work in progress. Harcke HT, Zapf SE, Mandell GA, Sharkey CA, Cooley LA. Radiology. 1987 Aug;164(2):437-40. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43854 |
Study title: The primary objective was to evaluate the safety of ampicillin suppositories with special emphasis on local intolerance reactions in pediatric patients. The secondary objective was to evaluate short term efficacy in the treatment of acute otitis media. The study was comparative against amoxIcillin suspension.Bagger-Sjöbäck et al. (1987-07-22) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_24.xlsx |
View full study record |
Document reference: 49023 |
Study title: Murray IP, Frater CJ. Prominence of the C2 vertebra on SPECT. A normal variant. Clin Nucl Med. 1994 Oct;19(10):855-9. Murray IP, Frater CJ. Prominence of the C2 vertebra on SPECT. A normal variant. Clin Nucl Med. 1994 Oct;19(10):855-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43614 |
Study title: Oshiro N, Bito S, Ito H, Morimoto Y, Ikekubo K, Ishihara T, Mori T. [Fundamental and clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Kaku Igaku. 1982 Mar;19(2):305-11. Japanese. No abstract available. Oshiro N, Bito S, Ito H, Morimoto Y, Ikekubo K, Ishihara T, Mori T. [Fundamental and clinical evaluation of bone scintigraphy with 99mTc-HMDP (author's transl)] Kaku Igaku. 1982 Mar;19(2):305-11. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44091 |
Study title: Howman-Giles R, Rahilly PM. Technetium-99m methylene diphosphonate accumulation in the diaphragm after severe ischemia. Clin Nucl Med. 1983 Sep;8(9):416-7. No abstract available. Howman-Giles R, Rahilly PM. Technetium-99m methylene diphosphonate accumulation in the diaphragm after severe ischemia. Clin Nucl Med. 1983 Sep;8(9):416-7. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44030 |
Study title: Single-dose, double-blind, double dummy, mono-center, randomized two fold crossover study to assess the therapeutic equivalence of Formoterol versus Foradil Aerolizer 12 μg/dose in asthmatic pediatric subjects followed by a 1 month open-label period with |
Active substance: FORMOTEROL |
Study summary document link (including results): |
View full study record |
Document reference: 47865 |
Study title: Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 44192 |
Study title: Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 44239 |
Study title: Vattimo A, Martini G, Pisani M. Bone uptake of 99mTc-MDP in man: its relationship with local blood flow. J Nucl Med Allied Sci. 1982 Jul-Sep;26(3):173-9. No abstract available. Vattimo A, Martini G, Pisani M. Bone uptake of 99mTc-MDP in man: its relationship with local blood flow. J Nucl Med Allied Sci. 1982 Jul-Sep;26(3):173-9. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 44082 |
Study title: Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43828 |
Study title: Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44179 |
Study title: Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44226 |
Study title: Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. Lumbroso J, Guermazi F, Hartmann O, Coornaert S, Rabarison Y, Lemerle J, Parmentier C. [Sensitivity and specificity of meta-iodobenzylguanidine (mIBG) scintigraphy in the evaluation of neuroblastoma: analysis of 115 cases] Bull Cancer. 1988;75(1):97-106. French. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44273 |
Study title: Multifocal osteoarticular tuberculosis resembling skeletal metastatic disease. Evaluation with Tc-99m MDP and Ga-67 citrate. Hardoff R, Efrat M, Gips S. Clin Nucl Med. 1995 Mar;20(3):279-81. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43603 |
Study title: Strömqvist B. Femoral head vitality after intracapsular hip fracture. 490 cases studied by intravital tetracycline labeling and Tc-MDP radionuclide imaging. Acta Orthop Scand Suppl. 1983;200:1-71. No abstract available. Strömqvist B. Femoral head vitality after intracapsular hip fracture. 490 cases studied by intravital tetracycline labeling and Tc-MDP radionuclide imaging. Acta Orthop Scand Suppl. 1983;200:1-71. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44059 |
Study title: Sty JR, Boedecker RA, Babbitt DP. Skull scintigraphy in infantile hypophosphatasia. J Nucl Med. 1979 Apr;20(4):305-6. No abstract available. Sty JR, Boedecker RA, Babbitt DP. Skull scintigraphy in infantile hypophosphatasia. J Nucl Med. 1979 Apr;20(4):305-6. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44145 |
Study title: The primary objective was to evaluate the safety of ampicillin suppositories with special emphasis on local intolerance reactions in pediatric patients. The secondary objective was to evaluate efficacy of a twice daily dosage regimen in the treatment of acute otitis media. The study was comparative against amoxIcillin suspension.Albertini et al. (1987-09-11) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_26.xlsx |
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Document reference: 49025 |
Study title: The primary objective was to evaluate the safety of ampicillin suppositories with special emphasis on local intolerance reactions. The study was comparative against amoxIcillin suspension.Albertini et al. (1987-09-11) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_27.xlsx |
View full study record |
Document reference: 49026 |
Study title: Hung GL, Stewart CA, Yeo E, Ansari AN, Wang A, Greenfield L. Incidental demonstration of cerebral infarction on bone scintigraphy in sickle cell disease. Clin Nucl Med. 1990 Oct;15(10):671-2. No abstract available. Hung GL, Stewart CA, Yeo E, Ansari AN, Wang A, Greenfield L. Incidental demonstration of cerebral infarction on bone scintigraphy in sickle cell disease. Clin Nucl Med. 1990 Oct;15(10):671-2. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43752 |
Study title: Accumulation of Tc-99m HMDP in bony structures of immature teratoma in a child. Tohyama J, Ohba S, Sugie C, Ogino H, Hara M, Shibamoto Y. Clin Nucl Med. 2003 Apr;28(4):334-5. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43424 |
Study title: Tonami N. [Role of nuclear medicine in orthopedic surgery] Nippon Seikeigeka Gakkai Zasshi. 1987 Apr;61(4):411-24. Japanese. No abstract available. Tonami N. [Role of nuclear medicine in orthopedic surgery] Nippon Seikeigeka Gakkai Zasshi. 1987 Apr;61(4):411-24. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43870 |
Study title: Tovi F, Gatot A. Bone scan diagnosis of masked mastoiditis. Ann Otol Rhinol Laryngol. 1992 Aug;101(8):707-9. No abstract available. Tovi F, Gatot A. Bone scan diagnosis of masked mastoiditis. Ann Otol Rhinol Laryngol. 1992 Aug;101(8):707-9. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43693 |
Study title: A double-blind, 2x2 Factohal Study to evaluate the effects of treatment with intranasal fluticasone propionate and use of Otovent mechanical ventilation of the middle ear on the need for surgery in children aged 4-8 with chronic or recurrent otitis media. |
Active substance: FLUTICASONE |
Study summary document link (including results): Study FLNL45-Fluticasone_Flixonase.xls |
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Document reference: 28363 |
Study title: A multi-centre, randomised, double-blind, double-dummy, parallel-group study to determine the clinical equivalence between fluticasone propionate 100μg twice daily delivered via a multidose powder inhaler (MDPI) and the Diskhaler™ in adult and paediatric patients with reversible airways disease. |
Active substance: FLUTICASONE |
Study summary document link (including results): Fluticasone-propionate-FMDT02-ICHE3.pdf |
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Document reference: 28424 |
Study title: Lusins JO, Elting JJ, Cicoria AD, Goldsmith SJ. SPECT evaluation of lumbar spondylolysis and spondylolisthesis. Spine. 1994 Mar 1;19(5):608-12. Lusins JO, Elting JJ, Cicoria AD, Goldsmith SJ. SPECT evaluation of lumbar spondylolysis and spondylolisthesis. Spine. 1994 Mar 1;19(5):608-12. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43631 |
Study title: Lusins JO, Elting JJ, Cicoria AD, Goldsmith SJ. SPECT evaluation of unilateral spondylolysis. Clin Nucl Med. 1994 Jan;19(1):1-5. Lusins JO, Elting JJ, Cicoria AD, Goldsmith SJ. SPECT evaluation of unilateral spondylolysis. Clin Nucl Med. 1994 Jan;19(1):1-5. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43636 |
Study title: Pseudomonas sacroiliac osteomyelitis: diagnosis by gallium citrate Ga 67 scan. Pope TL, Teague WG, Kossack R, Bray ST, Flannery DB. Am J Dis Child. 1982 Jul;136(7):649-50. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44081 |
Study title: Sty JR, Starshak RJ, Casper JT. Extraosseous accumulation of Tc-99m MDP. Metastatic intracranial neuroblastoma. Clin Nucl Med. 1983 Jan;8(1):26-7. No abstract available. Sty JR, Starshak RJ, Casper JT. Extraosseous accumulation of Tc-99m MDP. Metastatic intracranial neuroblastoma. Clin Nucl Med. 1983 Jan;8(1):26-7. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44061 |
Study title: Accumulation of Tc-99m MDP in the spleen of a battered child. Sty JR, Starshak RJ, Hubbard A. Clin Nucl Med. 1982 Jun;7(6):292. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44083 |
Study title: Sty JR, Starshak RJ, Oechler HW. Extraosseous uptake of Tc-99m-MDP in congenital fibromatosis. Clin Nucl Med. 1981 Mar;6(3):123. No abstract available. Sty JR, Starshak RJ, Oechler HW. Extraosseous uptake of Tc-99m-MDP in congenital fibromatosis. Clin Nucl Med. 1981 Mar;6(3):123. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44129 |
Study title: Sty JR, Starshak RJ. Abnormal Tc-99m MDP renal images associated with myoglobinuria. Clin Nucl Med. 1982 Oct;7(10):476. No abstract available. Sty JR, Starshak RJ. Abnormal Tc-99m MDP renal images associated with myoglobinuria. Clin Nucl Med. 1982 Oct;7(10):476. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44071 |
Study title: The role of bone scintigraphy in the evaluation of the suspected abused child. Sty JR, Starshak RJ. Radiology. 1983 Feb;146(2):369-75. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44051 |
Study title: Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44084 |
Study title: Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44186 |
Study title: Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44233 |
Study title: Tuncel M, Erbas B, Mahmoudian B. Gamut: soft tissue uptake of bone radiopharmaceuticals. Semin Nucl Med. 2003 Oct;33(4):334-7. No abstract available. Tuncel M, Erbas B, Mahmoudian B. Gamut: soft tissue uptake of bone radiopharmaceuticals. Semin Nucl Med. 2003 Oct;33(4):334-7. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43410 |
Study title: Turba E, Fagioli G, Mancini AF, Rosito P, Galli A, Alvisi P. Evaluation of stage 4 neuroblastoma patients by means of MIBG and 99mTc-MDP scintigraphy. J Nucl Biol Med. 1993 Sep;37(3):107-14. Turba E, Fagioli G, Mancini AF, Rosito P, Galli A, Alvisi P. Evaluation of stage 4 neuroblastoma patients by means of MIBG and 99mTc-MDP scintigraphy. J Nucl Biol Med. 1993 Sep;37(3):107-14. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43655 |
Study title: Fibrous dysplasia in the spine: prevalence of lesions and association with scoliosis. Leet AI, Magur E, Lee JS, Wientroub S, Robey PG, Collins MT. J Bone Joint Surg Am. 2004 Mar;86-A(3):531-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43405 |
Study title: Left distal femoral diaphysis metaphyseal injury in a 13-year-old patient.Delgado Garcia M, Mitjavila Casanovas M, Balsa Breton MA, Castillejos Rodriguez L, Alonso Garcia P, Canamaque Garcia L, et al. Rev Esp Med Nucl 2000 Sep;19{5):356-60. [in Spanish] |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48474 |
Study title: The imaging diagnosis of nonpyogenic discitis in children.Grünebaum M, Horodniceanu C, Mukamel M, Varsano I, Lubin E. Pediatr Radiol. 1982;12(3):133-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44102 |
Study title: False positive bone scan secondary to sympathectomy following resection of a ganglioneuroblastoma or affect of unilateral sympathectomy of bone scan in the pediatric patient. Haggstrom JA, Brown JC. Nebr Med J. 1988 Mar;73(3):67-9. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43823 |
Study title: Silva F, Laguna R, Acevedo M, Ruíz C, Orduña E. Clin Nucl Med. 1995 Oct;20(10):913-5. Silva F, Laguna R, Acevedo M, Ruíz C, Orduña E. Clin Nucl Med. 1995 Oct;20(10):913-5. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43584 |
Study title: Silvestro L, Bona G, Leonessa M, Giusti M, Mussa GC. [Importance of bone scintigraphy in skeletal diseases] Minerva Pediatr. 1983 Nov 15;35(21):1051-7. Italian. No abstract available. Silvestro L, Bona G, Leonessa M, Giusti M, Mussa GC. [Importance of bone scintigraphy in skeletal diseases] Minerva Pediatr. 1983 Nov 15;35(21):1051-7. Italian. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44022 |
Study title: Silvestro L, Savant Levet P, Gallina MR. [Role of sequential Tc99m-MDP and Ga-67 scintigraphy in the diagnosis of osteoarticular infections] Minerva Pediatr. 1988 Feb;40(2):103-8. Italian. No abstract available. Silvestro L, Savant Levet P, Gallina MR. [Role of sequential Tc99m-MDP and Ga-67 scintigraphy in the diagnosis of osteoarticular infections] Minerva Pediatr. 1988 Feb;40(2):103-8. Italian. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43826 |
Study title: [Scintigraphy in the diagnosis and follow-up of bone neoplasms in childhood] Silvestro L, Testa A, Mussa GC. Minerva Pediatr. 1987 May 31;39(10):463-70. Italian. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43862 |
Study title: Sires BS, Benda PM, Stanley RB Jr, Rosen CE. Orbital osteoid osteoma. Arch Ophthalmol. 1999 Mar;117(3):414-5. No abstract available. Sires BS, Benda PM, Stanley RB Jr, Rosen CE. Orbital osteoid osteoma. Arch Ophthalmol. 1999 Mar;117(3):414-5. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43510 |
Study title: Baldini G. et al Controlled clinical study on the activity of a new formulation of Ambroxol in asthma-like bronchitis in children.MinervaPed,1989,Baldini |
Active substance: AMBROXOL |
Study summary document link (including results): MinervaPed,1989,Baldini.pdf |
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Document reference: 48876 |
Study title: Intense muscle uptake of Tc-99m MDP and Ga-67 citrate in massive rhabdomyolysis. Provan I, Murray C, Mansberg VJ, Rossleigh MA. Clin Nucl Med. 1997 Jul;22(7):463-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43548 |
Study title: Determine the plasma concentrations after rectal administration of ampicillin suppositories in children, and when possible to estimate the urine concentrations of ampicillin and the bioavailability of the suppository.Eriksson et al. (1991-08-12) |
Active substance: AMPICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_28.xlsx |
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Document reference: 49027 |
Study title: Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. Kosuda S, Kondo M, Masaki H, Endo M, Ando Y, Takagi Y, Kubo A, Hashimoto S. [Significance of bone scintigraphy in the observation of the therapeutic effects in metastatic bone cancer] Nippon Igaku Hoshasen Gakkai Zasshi. 1982 May 25;42(5):454-66. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44280 |
Study title: Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43855 |
Study title: Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. Krasnow AZ, Collier BD, Kneeland JB, Carrera GF, Ryan DE, Gingrass D, Sewall S, Hellman RS, Isitman AT, Froncisz W, et al. Comparison of high-resolution MRI and SPECT bone scintigraphy for noninvasive imaging of the temporomandibular joint. J Nucl Med. 1987 Aug;28(8):1268-74. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44181 |
Study title: [Advantages and disadvantages of peroperative isotopic localization in the excision of osteoid osteoma. Considerations apropos of 6 cases] French. Nachin P, Gille P, Aubert D, De La Salle R, Giordan H, Cardot JC. Chir Pediatr. 1986;27(2):65-8. French. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43921 |
Study title: Nair N, Goyal V, Nair CN. Uptake of Tc-99m MDP by a primitive neuroectodermal tumor of the liver. Clin Nucl Med. 1998 Aug;23(8):548-9. No abstract available. Nair N, Goyal V, Nair CN. Uptake of Tc-99m MDP by a primitive neuroectodermal tumor of the liver. Clin Nucl Med. 1998 Aug;23(8):548-9. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43527 |
Study title: Otsuka N, Yoneda M, Sawai M, Saito J, Nagai K, Muranaka A, Terashima H, Yanagimoto S, Ito Y. [Clinical studies on bone deposition of 99mTc-labeled-DPD (dicarboxypropane diphosphonate): a comparison with 99mTc-methylene diphosphonate] Kaku Igaku. 1982 Dec;19(10):1573-8. Japanese. No abstract available. Otsuka N, Yoneda M, Sawai M, Saito J, Nagai K, Muranaka A, Terashima H, Yanagimoto S, Ito Y. [Clinical studies on bone deposition of 99mTc-labeled-DPD (dicarboxypropane diphosphonate): a comparison with 99mTc-methylene diphosphonate] Kaku Igaku. 1982 Dec;19(10):1573-8. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44278 |
Study title: Oza UD, Oates E. Rhabdomyolysis of bilateral teres major muscles. Clin Nucl Med. 2003 Feb;28(2):126-7. No abstract available. Oza UD, Oates E. Rhabdomyolysis of bilateral teres major muscles. Clin Nucl Med. 2003 Feb;28(2):126-7. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43430 |
Study title: Palestro C, Lawrence LP, Strashun AM, Goldsmith SJ. Technetium-99m MDP accumulation in hepatic metastasis from osteogenic sarcoma. Clin Nucl Med. 1987 Apr;12(4):329-30. No abstract available. Palestro C, Lawrence LP, Strashun AM, Goldsmith SJ. Technetium-99m MDP accumulation in hepatic metastasis from osteogenic sarcoma. Clin Nucl Med. 1987 Apr;12(4):329-30. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43867 |
Study title: Smirnov IuN, Mytnikov AM, Ivanov LB, Suchkov VV, Strunin EG. [Distant compression fracture in a child with dysplastic changes in the spine] Med Radiol (Mosk). 1988 Jul;33(7):79-80. Russian. No abstract available. Smirnov IuN, Mytnikov AM, Ivanov LB, Suchkov VV, Strunin EG. [Distant compression fracture in a child with dysplastic changes in the spine] Med Radiol (Mosk). 1988 Jul;33(7):79-80. Russian. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43813 |
Study title: Detection of adrenal metastasis from osteosarcoma by Tc-99m MDP scintigraphy. Kauffman WM, Winer-Muram H, Sandlund JT. Clin Nucl Med. 1995 Aug;20(8):741. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43592 |
Study title: Joyce JM, Conrad G, Shih WJ, Ryo UY. Arterial thrombosis and insufficiency causing diffusely decreased uptake by skeleton of a limb. Semin Nucl Med. 1991 Apr;21(2):165-6. No abstract available. Joyce JM, Conrad G, Shih WJ, Ryo UY. Arterial thrombosis and insufficiency causing diffusely decreased uptake by skeleton of a limb. Semin Nucl Med. 1991 Apr;21(2):165-6. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43742 |
Study title: Unilateral medullary sponge kidney detected on bone scan. Juweid M, Richards CH, Heyman S. Clin Nucl Med. 1993 Jan;18(1):73-4. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43675 |
Study title: Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. Veldman JE, Mulder PH, Ruijs SH, de Haas G, van Waes PF, Hoekstra A. Early detection of asymptomatic hereditary chemodectoma with radionuclide scintiangiography. A possibility for family screening and surveillance. Arch Otolaryngol. 1980 Sep;106(9):547-52. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44286 |
Study title: Veluvolu P, Zoch TW, Miller RW, Weir JG, Mulligan CM, Moen SL. Pseudo-bladder sign in an unsuspected pregnancy. Appearance in bone imaging. Clin Nucl Med. 1992 Dec;17(12):982-3. No abstract available. Veluvolu P, Zoch TW, Miller RW, Weir JG, Mulligan CM, Moen SL. Pseudo-bladder sign in an unsuspected pregnancy. Appearance in bone imaging. Clin Nucl Med. 1992 Dec;17(12):982-3. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43682 |
Study title: Narang D, Bharati B, Bhattacharya A, Mittal BR. Radionuclide bone scintigraphy in Engelmann-Camurati disease. Arch Dis Child. 2004 Aug;89(8):737. No abstract available. Narang D, Bharati B, Bhattacharya A, Mittal BR. Radionuclide bone scintigraphy in Engelmann-Camurati disease. Arch Dis Child. 2004 Aug;89(8):737. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43399 |
Study title: Malignant fibrous histiocytoma of the mandible. Narvaez JA, Muntane A, Narvaez J, Martin F, Monfort JL, Pons LC. Skeletal Radiol. 1996 Jan;25(1):96-9. Review. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43573 |
Study title: Ncube BA. Pyogenic sacroiliitis in children. Br J Clin Pract. 1988 Apr;42(4):154-7. No abstract available. Ncube BA. Pyogenic sacroiliitis in children. Br J Clin Pract. 1988 Apr;42(4):154-7. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43822 |
Study title: Hashkes PJ, Gorenberg M, Oren V, Friedland O, Uziel Y. "Growing pains" in children are not associated with changes in vascular perfusion patterns in painful regions. Clin Rheumatol. 2005 Aug;24(4):342-5. Epub 2004 Nov 26. Hashkes PJ, Gorenberg M, Oren V, Friedland O, Uziel Y. "Growing pains" in children are not associated with changes in vascular perfusion patterns in painful regions. Clin Rheumatol. 2005 Aug;24(4):342-5. Epub 2004 Nov 26. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43386 |
Study title: Haskok SN, Konez O. Mixed form lymphatic malformation of the foot simulating acute soft-tissue lesion on 3-phase bone scintigraphy. Clin Nucl Med. 2004 Jan;29(1):48-50. No abstract available. Haskok SN, Konez O. Mixed form lymphatic malformation of the foot simulating acute soft-tissue lesion on 3-phase bone scintigraphy. Clin Nucl Med. 2004 Jan;29(1):48-50. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43406 |
Study title: Hayasaka K, Amoh K. [Extra-osseous tumor uptake of bone seeking agents] Kaku Igaku. 1982 Sep;19(8):1243-8. Japanese. No abstract available. Hayasaka K, Amoh K. [Extra-osseous tumor uptake of bone seeking agents] Kaku Igaku. 1982 Sep;19(8):1243-8. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44075 |
Study title: Hayasaka K, Arakawa K, Sugie H, Amoh K. [An experience with 99mTc-hydroxy methylene diphosphonate (99mTc-HMDP) as a new bone scanning agent] Radioisotopes. 1984 Oct;33(10):714-6. Japanese. No abstract available. Hayasaka K, Arakawa K, Sugie H, Amoh K. [An experience with 99mTc-hydroxy methylene diphosphonate (99mTc-HMDP) as a new bone scanning agent] Radioisotopes. 1984 Oct;33(10):714-6. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43979 |
Study title: Hayasaka K, Sugie H, Saitoh Y, Arakawa K, Amoh K. [Extraosseous tumor uptake of 99m-Tc-MDP] Rinsho Hoshasen. 1985 Jan;30(1):61-5. Japanese. No abstract available. Hayasaka K, Sugie H, Saitoh Y, Arakawa K, Amoh K. [Extraosseous tumor uptake of 99m-Tc-MDP] Rinsho Hoshasen. 1985 Jan;30(1):61-5. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43967 |
Study title: Purello−D−Ambrosio−F, Tigano−F, Gallesio−M−T, Chevallier−P, Janssens− M. Astemizole−D compared with triprolidine−D (Actifedregistered trade mark) for acute treatment of perennial allergic rhinitis. Journal of Pharmaceutical Medicine {J−PHARM−MED}, 1994, Vol/Iss/Pg. 4 /1 (15−22). Purello−D−Ambrosio−F, Tigano−F, Gallesio−M−T, Chevallier−P, Janssens− M. Astemizole−D compared with triprolidine−D (Actifedregistered trade mark) for acute treatment of perennial allergic rhinitis. Journal of Pharmaceutical Medicine {J−PHARM−MED}, 1994, Vol/Iss/Pg. 4 /1 (15−22). |
Active substance: GUAIFENESIN AND PSEUDOEPHEDRINE AND TRIPTOLIDINE |
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Document reference: 29054 |
Study title: Parvez−L, Vaidya−M, Sakhardande−A, Subburaj−S, Rajagopalan−T−G. Evaluation of antitussive agents in man. Pulmonary pharmacology, {Pulm−Pharmacol}, Oct−Dec 1996, vol. 9, no. 5−6, p. 299−308.Parvez−L, Vaidya−M, Sakhardande−A, Subburaj−S, Rajagopalan−T−G. Evaluation of antitussive agents in man. Pulmonary pharmacology, {Pulm−Pharmacol}, Oct−Dec 1996, vol. 9, no. 5−6, p. 299−308. |
Active substance: GUAIFENESIN OR GUAIFENESIN AND LEVOMENTHOL |
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Document reference: 29062 |
Study title: A phase II, double-blind, randomized study to compare the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals¿ Tritanrix¿-HepBlow thio/Hib2.5 Gödöllö to GSK Biologicals¿ Tritanrix¿-HepB/Hiberix¿Gödöllö when administered as a three-dose primary vaccination course to healthy infants at 6, 10 and 14 weeks of age. A dose of unconjugated Hib vaccine (plain PRP booster) will be administered at the age of 10 months to 50% of the subjects. Note: This report presents the results pertaining to the plain PRP challenge at 10 months of age. |
Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT) |
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Document reference: 41159 |
Study title: Kirchner PT, Simon MA. The clinical value of bone and gallium scintigraphy for soft-tissue sarcomas of the extremities. J Bone Joint Surg Am. 1984 Mar;66(3):319-27. Kirchner PT, Simon MA. The clinical value of bone and gallium scintigraphy for soft-tissue sarcomas of the extremities. J Bone Joint Surg Am. 1984 Mar;66(3):319-27. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44005 |
Study title: Middendorf PR, Marti RK. [Difficulties and possibilities in the detection and removal of osteoid osteoma] Ned Tijdschr Geneeskd. 1985 May 18;129(20):929-32. Dutch. No abstract available. Middendorf PR, Marti RK. [Difficulties and possibilities in the detection and removal of osteoid osteoma] Ned Tijdschr Geneeskd. 1985 May 18;129(20):929-32. Dutch. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43943 |
Study title: Evaluate efficacy in spefic infections and to compare amoxicillin 250 mg qid and 500 mg bd.Andrews et al |
Active substance: AMOXICILLIN |
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Document reference: 48972 |
Study title: Vernigora IP, Prokopchuk VF, Gritsaĭ NP, Radchenko DP. [Scintigraphy in the prognosis of the outcome of a free autoplasty in cases of suppurative infection] Ortop Travmatol Protez. 1988 Sep;(9):62. Russian. No abstract available. Vernigora IP, Prokopchuk VF, Gritsaĭ NP, Radchenko DP. [Scintigraphy in the prognosis of the outcome of a free autoplasty in cases of suppurative infection] Ortop Travmatol Protez. 1988 Sep;(9):62. Russian. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43811 |
Study title: Unexpected myocardial uptake on bone scintigraphy in an infant with Kawasaki disease. Macdonald WB, Troedson RG. Clin Nucl Med. 2001 May;26(5):455. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43454 |
Study title: A rare cause of rickets in a young child. Machiels F, De Maeseneer M, Van Snick A, Rayen I, Desprechins B, Osteaux M. J Belge Radiol. 1995 Oct;78(5):276-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43585 |
Study title: Haynie TP. Prognosis by nuclear medicine: can functional staging of cancer patients predict therapeutic response and survival? J Nucl Med. 1993 Jul;34(7):1087-9. No abstract available. Haynie TP. Prognosis by nuclear medicine: can functional staging of cancer patients predict therapeutic response and survival? J Nucl Med. 1993 Jul;34(7):1087-9. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43661 |
Study title: Hematogenous pyogenic vertebral osteomyelitis: diagnostic value of radionuclide bone imaging. Adatepe MH. Powell OM. Isaacs GH. Nichols K. Cefola R. J Nucl Med 1986 Nov;27(11):1680-5. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 48463 |
Study title: Abnormal Tc-99m MDP renal images associated with hemolytic streptococcal sepsis. Sty JR, Wells RG, Ruiz ME. Clin Nucl Med. 1995 Oct;20(10):944. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43582 |
Study title: Resolved splenic accumulation of Tc-99m HMDP after recovery of disseminated intravascular coagulation in a patient with rhabdomyosarcoma. Suga K, Matsunaga N, Kawamura T, Hara A, Kume N. Clin Nucl Med. 1999 Jun;24(6):414-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43507 |
Study title: Sugimura K, Narabayashi I, Yamazaki K, Fukugawa T, Sugimura C, Matsuo M, Nishiyama S, Kimura S. [Bone scintigraphic findings in 2 cases of myositis ossificans progressiva] Kaku Igaku. 1983 Jul;20(6):875-9. Japanese. No abstract available. Sugimura K, Narabayashi I, Yamazaki K, Fukugawa T, Sugimura C, Matsuo M, Nishiyama S, Kimura S. [Bone scintigraphic findings in 2 cases of myositis ossificans progressiva] Kaku Igaku. 1983 Jul;20(6):875-9. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44034 |
Study title: Reimão R, Lefévre AB.: Evaluation of flurazepam and placebo on sleep disorders in childhood. Arq Neuropsiquiatr. 1982 Mar;40(1):1-13. |
Active substance: FLURAZEPAM |
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Document reference: 28345 |
Study title: VALUTAZIONE IN PEDIATRIA DELL'ATTIVITA' IPNOINDUCENTE DEL FLURAZEPAM GOCCE (VAL 779) Rapisarda V.; Germana B. Formazione Psichiatrica, December 1, 1980 , No. 4/- (181-190) Evaluation of flurazepam and placebo on sleep disorders in childhood. Reimão R, Lefévre AB. Arq Neuropsiquiatr. 1982 Mar;40(1):1-13. |
Active substance: FLURAZEPAM |
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Document reference: 28344 |
Study title: Sequential radionuclide bone imaging in avascular pediatric hip conditions. Minikel J, Sty J, Simons G. Clin Orthop Relat Res. 1983 May;(175):202-8. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44038 |
Study title: Evaluate the efficacy of amoxicillin i ndifferent dosages i nthe treatment of gonococcal urethritis in the male. Compare the results with stnadard treatment.Watt et al. |
Active substance: AMOXICILLIN |
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Document reference: 48970 |
Study title: Controlled clinical study on the activity of a new mucoregulating drug in obstructive bronchial pathology with a marked hypersecretory feature. Paediatric experience. Min.Ped.1984,36(3),127-138. Romano C. et al. Minerva Pediatrica 1984, Romano |
Active substance: AMBROXOL |
Study summary document link (including results): Minerva Pediatrica 1984, Romano.pdf |
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Document reference: 48874 |
Study title: Miller TW, Heck LL, Kight JL, McCarroll JR, Shelbourne KD, Van Hove ED. A clinical and radiological review of stress fractures in competitive and non-competitive athletes. Indiana Med. 1987 Oct;80(10):942-9. No abstract available. Miller TW, Heck LL, Kight JL, McCarroll JR, Shelbourne KD, Van Hove ED. A clinical and radiological review of stress fractures in competitive and non-competitive athletes. Indiana Med. 1987 Oct;80(10):942-9. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43848 |
Study title: A phase III, observer-blind, single-centre, randomized study to evaluate safety and immunogenicity of three lots of DTwPHib full liquid vaccine (Chiron Vaccines; now Novartis Vaccines) and of American Home Product (AHP-Wyeth) Tetramune (DTwPHib) vaccine administered to healthy infants at 2, 3 and 4 months of age.Please see report- sturdy report |
Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
Study summary document link (including results): V38P2.xlsx |
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Document reference: 49184 |
Study title: A randomized, stratified, double blind trial to compare safety and efficacy of the Fluvirin® Vaccine (a purified surface antigen vaccine) with Connaught Inactivated Influenza Vaccine Fluzone® (a split virion vaccine) in healthy children aged 6 to 47 months of age.Nicolay 1999, Vaccine 17 (1999) 2223-2228 |
Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
Study summary document link (including results): MPL-318-01.xlsx |
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Document reference: 49190 |
Study title: Esomeprazole Magnesium: An 8 Week Oral (Gavage) Toxicity and Toxicokinetic Study in the Neonatal and Young Adult Beagle Dog (a Complementary Study). AstraZeneca R&D Södertälje, Safety Assessment, Sweden (Charles River Laboratories Preclinical Services Mo |
Active substance: ESOMEPRAZOLE |
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Document reference: 26610 |
Study title: Diptheria booster vaccination one or two injections_1999Nicolay 1999, Vaccine 17 (1999) 2223-2228 |
Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
Study summary document link (including results): Nicolay_Diptheria booster vaccination one or two injections_1999.pdf |
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Document reference: 49189 |
Study title: Pilar 1983Please see report- sturdy report |
Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
Study summary document link (including results): Pilar 1983.pdf |
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Document reference: 49188 |
Study title: An open label, not randomized, age stratified trial to study safety and efficacy of the vaccine in subjects from 6 to 35 months of age.Please see report - study report |
Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
Study summary document link (including results): MEMUFL-95-001.xlsx |
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Document reference: 49191 |
Study title: Publication_8T-201RAPlease see report- sturdy report |
Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
Study summary document link (including results): Publication_8T-201RA.pdf |
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Document reference: 49187 |
Study title: Response to Diphtheria and Tetanus Booster Vaccination in pediatric renal transplantTransplantation, Issue: Volume 64(2),27 July 1997,pp 237-241, Enke |
Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
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Document reference: 49193 |
Study title: Safety and immunogenicity of anew fully liquid DTPw-HepB-Hib combination vaccine in infantsKanra_et_al_2006_Publication |
Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
Study summary document link (including results): Kanra_et_al_2006_Publication.pdf |
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Document reference: 49192 |
Study title: Gregianin LJ et al Clinical and pharmacokinetic study of fractionated doses of oral etoposide in pediatric patients with advanced malignancies Med Sci Monit 2002 Sep;8(9):PI70-7Gregianin LJ et al Clinical and pharmacokinetic study of fractionated doses of oral etoposide in pediatric patients with advanced malignancies Med Sci Monit 2002 Sep;8(9):PI70-7 |
Active substance: CYCLOPHOSPHAMIDE |
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Document reference: 24913 |
Study title: Casanova M et al Etoposide, cisplatin, epirubicin chemotherapy in the treatment of pediatric liver tumors Pediatr Hematol Oncol 2005 Apr-May;22(3):189-98Casanova M et al Etoposide, cisplatin, epirubicin chemotherapy in the treatment of pediatric liver tumors Pediatr Hematol Oncol 2005 Apr-May;22(3):189-98 |
Active substance: CYCLOPHOSPHAMIDE |
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Document reference: 24816 |
Study title: Schiavetti A et al Ten-day schedule oral etoposide therapy in advanced childhood malignancies J Pediatr Hematol Oncol 2000 Mar-Apr;22(2):119-24Schiavetti A et al Ten-day schedule oral etoposide therapy in advanced childhood malignancies J Pediatr Hematol Oncol 2000 Mar-Apr;22(2):119-24 |
Active substance: CYCLOPHOSPHAMIDE |
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Document reference: 25110 |
Study title: open uncontrolled study to evaluate the acceptance and tolerance of flucloxacillin suspension.Lidgren. Clinical trial on flucloxacillin suspension in children. |
Active substance: FLUCLOXACILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Flukloxacillin_2.xlsx |
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Document reference: 49075 |
Study title: Compare the effectiveness in the treatment of chronic constipation of a lactulose preparation ("Duphalac") and "irritant" laxatives containing senna, anthraquinone derivatives or bisacodyl.Connolly et al |
Active substance: LACTULOSE |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Lactulose_2.xlsx |
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Document reference: 49067 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Cinnamomum-Homaccord N (drops) [AWB-AT] |
Active substance: Cinnamomum-Homaccord N |
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Document reference: 39829 |
Study title: Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma Cancer2003; 98: 389-396 Van Santen HM., 2003 |
Active substance: LEVOTHYROXINE |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48986 |
Study title: Three-Year follow-up of borderline congenital hypothyroidismJ Pediatr 2000; 136: 53-56 Daliva AL., 2000 |
Active substance: LEVOTHYROXINE |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48979 |
Study title: Triiodothyronine and thyroxine treatment of diffuse non-toxic goiter evaluated by ultrasonic scanningActa Endocrinol (Copenh) 1982; 100: 382-387 Perrild, H., 1982Acta Endocrinol (Copenh) 1982; 100: 382-387 Perrild, H., 1982 |
Active substance: LEVOTHYROXINE |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48989 |
Study title: Triiodothyronine and thyroxine treatment of diffuse non-toxic goiter evaluated by ultrasonic scanning Acta Endocrinol (Copenh) 1982; 100: 382-387 Perrild, H., 1982 |
Active substance: LIOTHYRONINE |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48977 |
Study title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Lovastatin as an Adjunct to Diet in the Treatment of Adolescent Males WitH Hypercholesterolemia of Familial Basis |
Active substance: LOVASTATIN |
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Document reference: 31473 |
Study title: Comparison of the effects of fluticasone propionate, aqueous nasal spray and levocabastine on inflammatory cells in nasal lavage and clinical activity during the pollen season in seasonal rhinitis. Clinical and Experimental Allergy 29, p. 1367-1 377, 1999Comparison of the effects of fluticasone propionate, aqueous nasal spray and levocabastine on inflammatory cells in nasal lavage and clinical activity during the pollen season in seasonal rhinitis. Clinical and Experimental Allergy 29, p. 1367-1 377, 1999 |
Active substance: LEVOCABASTINE |
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Document reference: 31137 |
Study title: Immunogenicity and safety of Rouvax vaccine in different age-group Thai children |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
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Document reference: 41242 |
Study title: Study title not availableStudy title not available |
Active substance: DICLOFENAC |
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Document reference: 26005 |
Study title: Osborn, D.A., N. Evans, and M. Kluckow, Left ventricular contractility in extremely premature infants in the first day and response to inotropes. Pediatr Res, 2007. 61(3): p. 335-40. Osborn, D.A., N. Evans, and M. Kluckow, Left ventricular contractility in extremely premature infants in the first day and response to inotropes. Pediatr Res, 2007. 61(3): p. 335-40. |
Active substance: DOBUTAMINE |
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Document reference: 26290 |
Study title: Mehta V, Singhi P, Singhi S. Intravenous sodium valproate versus diazepam infusion for the control of refractory status epilepticus in children: a randomized controlled trial. J Child Neurol. 2007 Oct;22(10):1191-7.Mehta V, Singhi P, Singhi S. Intravenous sodium valproate versus diazepam infusion for the control of refractory status epilepticus in children: a randomized controlled trial. J Child Neurol. 2007 Oct;22(10):1191-7. |
Active substance: DIAZEPAM |
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Document reference: 25938 |
Study title: Doppler study of myometrium in invasive gestational trophoblastic disease. |
Active substance: DACTINOMYCIN |
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Document reference: 25333 |
Study title: Comparative study of angiotensin converting enzyme inhibitor and calcium channel blocker in the treatment of steroid−resistant idiopathic nephrotic syndrome.Kumar NS, Singh A K, Mishra RN, Prakash J. The Journal of the Association of Physicians of India, Jun 2004, vol. 52, p. 454−8, Comparative study of angiotensin converting enzyme inhibitor and calcium channel blocker in the treatment of steroid−resistant idiopathic nephrotic syndrome.Kumar NS, Singh A K, Mishra RN, Prakash J. The Journal of the Association of Physicians of India, Jun 2004, vol. 52, p. 454−8, |
Active substance: VERAPAMIL |
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Document reference: 45535 |
Study title: Comparative study of the efficacy of metoprolol and verapamil in patients with syncope and positive head−up tilt test response.Walton SA, Berk M, Brook S. The Journal of clinical psychiatry, Nov 1996, vol. 57, no. 11, p. 543−6, Comparative study of the efficacy of metoprolol and verapamil in patients with syncope and positive head−up tilt test response.Walton SA, Berk M, Brook S. The Journal of clinical psychiatry, Nov 1996, vol. 57, no. 11, p. 543−6, |
Active substance: VERAPAMIL |
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Document reference: 45545 |
Study title: Comparison of bisoprolol and verapamil in hypertension: influence on left ventricular mass and function−−a pilot study.Ostman−Smith I, Wettrell G, Riesenfeld T. Journal of the American College of Cardiology, 15 Nov 1999, vol. 34, no. 6, p.1813−22, Comparison of bisoprolol and verapamil in hypertension: influence on left ventricular mass and function−−a pilot study.Ostman−Smith I, Wettrell G, Riesenfeld T. Journal of the American College of Cardiology, 15 Nov 1999, vol. 34, no. 6, p.1813−22, |
Active substance: VERAPAMIL |
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Document reference: 45541 |
Study title: (Effect of verapamil with renal disease basic−prescription on hemorheology indexes of type II nephrotic syndrome).Liang D, Li DD. Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine / Zhongguo Zhong xi yi jie he xue hui Zhongguo Zhong yi yan jiu yuan zhu ban, Feb 1993, vol. 13, no. 2, p. 86−7, 68, (Effect of verapamil with renal disease basic−prescription on hemorheology indexes of type II nephrotic syndrome).Liang D, Li DD. Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine / Zhongguo Zhong xi yi jie he xue hui Zhongguo Zhong yi yan jiu yuan zhu ban, Feb 1993, vol. 13, no. 2, p. 86−7, 68, |
Active substance: VERAPAMIL |
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Document reference: 45551 |
Study title: Effectiveness of the combination verapamil and chlorpromazine in the treatment of severe manic or mixed patients.Lenzi A, Marazziti D, Raffaelli S, Cassano GB. Progress in neuro−psychopharmacology & biological psychiatry, May 1995, vol. 19, no. 3, p. 519−28, Effectiveness of the combination verapamil and chlorpromazine in the treatment of severe manic or mixed patients.Lenzi A, Marazziti D, Raffaelli S, Cassano GB. Progress in neuro−psychopharmacology & biological psychiatry, May 1995, vol. 19, no. 3, p. 519−28, |
Active substance: VERAPAMIL |
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Document reference: 45548 |
Study title: Effects of verapamil on anthracycline−induced cardiomyopathy: preliminary results of a prospective multicenter trial.Kraft J, Grille W, Appelt M, Hossfeld DK, Eichelbaum M, Koslowski B, Quabeck K, Kuse R, Büchner T, Hiddemann W, et al. Haematology and blood transfusion, 1990, vol. 33, p. 566−70,Effects of verapamil on anthracycline−induced cardiomyopathy: preliminary results of a prospective multicenter trial.Kraft J, Grille W, Appelt M, Hossfeld DK, Eichelbaum M, Koslowski B, Quabeck K, Kuse R, Büchner T, Hiddemann W, et al. Haematology and blood transfusion, 1990, vol. 33, p. 566−70, |
Active substance: VERAPAMIL |
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Document reference: 45560 |
Study title: Evaluation of esophageal transit in children and in infants by means of Krypton-81m.Pediatr Radiol. 1985;15(3):161-4. Ham HR 1985 |
Active substance: krypton |
Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc |
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Document reference: 48548 |
Study title: Evaluation of the Accuracy of Steady-State Krypton-Sim Method for Calculating Right Ventricular Ejection FractionHamphrey R. Ham. Philipe R. Franken, Bernard Georges, Eric Delcourt, Marcel Guillaume, and Amnon Piepsz.J NucÃMed 27:593-601, 1986 |
Active substance: krypton |
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Document reference: 48531 |
Study title: Bronchiectasis in childhood. Comparison of chest roentgenograms, bronchography and lung scintigraphy.Pediatr Radiol. 1980 Jul;9(4):193-8. Vandevivere J 1980 |
Active substance: krypton |
Study summary document link (including results): 2011-09 GE response Krypton List of published articles.doc |
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Document reference: 48556 |
Study title: Bilchik T, Heyman S, Siegel A, Alavi A. Osteoid osteoma: the role of radionuclide bone imaging, conventional radiography and computed tomography in its management. J Nucl Med. 1992 Feb;33(2):269-71. No abstract available. Bilchik T, Heyman S, Siegel A, Alavi A. Osteoid osteoma: the role of radionuclide bone imaging, conventional radiography and computed tomography in its management. J Nucl Med. 1992 Feb;33(2):269-71. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43707 |
Study title: Efficacy and safety of verapamil SR 240 mg in essential hypertension: results of a multicentric phase IV study.Speders S, Sosna J, Schumacher A, Pfennigsdorf G. Journal of cardiovascular pharmacology, 1989, vol. 13 Suppl 4, p. S47−9,Efficacy and safety of verapamil SR 240 mg in essential hypertension: results of a multicentric phase IV study.Speders S, Sosna J, Schumacher A, Pfennigsdorf G. Journal of cardiovascular pharmacology, 1989, vol. 13 Suppl 4, p. S47−9, |
Active substance: VERAPAMIL |
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Document reference: 45561 |
Study title: Single-dose amoxicillin therapy with follow-up urine culture. Effective initial management for acute uncomplicated urinary tract infections. Savard-Fenton M, Fenton BW, Reller LB, Lauer BA, Byyny RL. Am J Med. 1982 Dec;73(6):808-13. |
Active substance: AMOXICILLIN |
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Document reference: 48968 |
Study title: The purpose uf this study was to determine what beneficiaI effect, if any, large doses of penicillin G procaine have on the treatment of hospitalized patients with pneumococcal pneumonia of varying severity, and to examine the effect of this treatment on the colonization and superinfection rates in these patients.Brewin et al. (JAMA 230:409-413, 1974) |
Active substance: BENZATHINE BENZYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Benzylpenicillin sodium_3.xlsx |
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Document reference: 49072 |
Study title: Safety and immunogenicity of acellular pertussis combined with tetanus and diphtheria toxoids adsorbed and inactivated poliomyelitis vaccine (TdcP-IPV) in adolescents and adults compared to Td-mlPV and cP given separately in adolescents and compared to TdcP or Td given separately with IPV or cP in adults |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 21208 |
Study title: A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. (Jan 1988) |
Active substance: IBUPROFEN |
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Document reference: 29380 |
Study title: Treatment of Refractory Arrhythmias with Propafenone in Pediatric Patients |
Active substance: PROPAFENONE |
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Document reference: 35058 |
Study title: Healy-G-B. Dept. Otolaryngol., Harvard Med. Sch., Boston, Mass., United States. Malignant tumors of the head and neck in children: diagnosis and treatment. Otolaryngologic Clinics of North America {OTOLARYNGOL-CLIN-NORTH-AM}, 1980, Vol/Iss/Pg. 13/3 (483-488).Healy-G-B. Dept. Otolaryngol., Harvard Med. Sch., Boston, Mass., United States. Malignant tumors of the head and neck in children: diagnosis and treatment. Otolaryngologic Clinics of North America {OTOLARYNGOL-CLIN-NORTH-AM}, 1980, Vol/Iss/Pg. 13/3 (483-488). |
Active substance: PROCARBAZINE |
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Document reference: 34736 |
Study title: Evaluation of the effects of fixed combinations of sustained−release verapamil/trandolapril versus captopril/hydrochlorothiazide on metabolic and electrolyte parameters in patients with essential hypertension.Cifková R, Nakov R, Novozámská E, Hejl Z, Petrzílková Z, Poledne R, Stávek P, Compagnone D. Journal of human hypertension, Jun 2000, vol. 14, no. 6, p. 347−54, Evaluation of the effects of fixed combinations of sustained−release verapamil/trandolapril versus captopril/hydrochlorothiazide on metabolic and electrolyte parameters in patients with essential hypertension.Cifková R, Nakov R, Novozámská E, Hejl Z, Petrzílková Z, Poledne R, Stávek P, Compagnone D. Journal of human hypertension, Jun 2000, vol. 14, no. 6, p. 347−54, |
Active substance: VERAPAMIL |
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Document reference: 45539 |
Study title: Factors influencing the prediction of steady state concentrations of digoxin.Nakamura T, Kakumoto M, Yamashita K, Takara K, Tanigawara Y, Sakaeda T, Okumura K. Biological & pharmaceutical bulletin, Apr 2001, vol. 24, no. 4, p. 403−8,Factors influencing the prediction of steady state concentrations of digoxin.Nakamura T, Kakumoto M, Yamashita K, Takara K, Tanigawara Y, Sakaeda T, Okumura K. Biological & pharmaceutical bulletin, Apr 2001, vol. 24, no. 4, p. 403−8, |
Active substance: VERAPAMIL |
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Document reference: 45538 |
Study title: Gilligan DM, Chan WL, Joshi J, Clarke P, Fletcher A, Krikler S, Oakley CM. Journal of the American College of Cardiology, Jun 1993, vol. 21, no. 7, p. 1672−9, Gilligan DM, Chan WL, Joshi J, Clarke P, Fletcher A, Krikler S, Oakley CM. Journal of the American College of Cardiology, Jun 1993, vol. 21, no. 7, p. 1672−9, |
Active substance: VERAPAMIL |
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Document reference: 45552 |
Study title: Intravenous tetrandrine in terminating acute episodes of paroxysmal supraventricular tachycardia.Dai GZ, Zeng B, ZhangYL, Lu YX. Chinese medical journal, , Jun 1990, vol. 103, no. 6, p. 460−3, Intravenous tetrandrine in terminating acute episodes of paroxysmal supraventricular tachycardia.Dai GZ, Zeng B, ZhangYL, Lu YX. Chinese medical journal, , Jun 1990, vol. 103, no. 6, p. 460−3, |
Active substance: VERAPAMIL |
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Document reference: 45558 |
Study title: Kiowski W, Bühler FR, Fadayomi MO, Erne P, Müller FB, Hulthén UL, Bolli P. The American journal of cardiology, 6 Dec 1985, vol. 56, no. 16, p. 81H−85H, Kiowski W, Bühler FR, Fadayomi MO, Erne P, Müller FB, Hulthén UL, Bolli P. The American journal of cardiology, 6 Dec 1985, vol. 56, no. 16, p. 81H−85H, |
Active substance: VERAPAMIL |
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Document reference: 45564 |
Study title: Lechenie sindroma Reino blokatorami vkhoda kal'tsiia. (Treatment of Raynaud's syndrome with calcium entry blockers).Shcherbakov AB, Guseva NG, Mach ES. Terapevticheskii arkhiv, 1987, vol. 59, no. 4, p. 89−92, Lechenie sindroma Reino blokatorami vkhoda kal'tsiia. (Treatment of Raynaud's syndrome with calcium entry blockers).Shcherbakov AB, Guseva NG, Mach ES. Terapevticheskii arkhiv, 1987, vol. 59, no. 4, p. 89−92, |
Active substance: VERAPAMIL |
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Document reference: 45562 |
Study title: Otsenka vozmozhnosti individual'nogo podbora antiaritmicheskoi terapii. (Evaluation of the possibility of selection of individual anti− arrhythmia therapy).Antonchenko IV, Gimrikh EO, Popov SV, Chekhov AM, Borisova EV, Savenkova GM, Plekhanov IG. Kardiologiia, Mar 1991, vol. 31, no. 3, p. 43−5, Otsenka vozmozhnosti individual'nogo podbora antiaritmicheskoi terapii. (Evaluation of the possibility of selection of individual anti− arrhythmia therapy).Antonchenko IV, Gimrikh EO, Popov SV, Chekhov AM, Borisova EV, Savenkova GM, Plekhanov IG. Kardiologiia, Mar 1991, vol. 31, no. 3, p. 43−5, |
Active substance: VERAPAMIL |
Study summary document link (including results): |
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Document reference: 45554 |
Study title: Betaxolol in the treatment of arterial hypertension: summary of clinical studies - MR95, MR17, MR107 Betaxolol Core Dossier - April 1999 - Part IVB1 Clinical documentation Volume 2 |
Active substance: BETAXOLOL |
Study summary document link (including results): |
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Document reference: 41926 |
Study title: Combined therapy with prednisolone, azathioprine, heparin-warfarin, and dipyridamole for paediatric patients with severe IgA nephropathy--is it relevant for adult patients?Yoshikawa N, Ito H. Nephrol Dial Transplant. 1999 May;14(5):1097-9. |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49227 |
Study title: Controlled trial of pulse versus continuous prednisolone and cyclophosphamide in the treatment of systemic vasculitis.Adu D, Pall A, Luqmani RA, Richards NT, Howie AJ, Emery P, Michael J, Savage CO, Bacon PA. QJM. 1997 Jun;90(6):401-9. |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49221 |
Study title: A phase III comparative study of the pharmacokinetic/pharmacodynamic and safety profiles of ibuprofen extended release, ibuprofen regular release and placebo during a 12 hour observation in post-extraction dental painA phase III comparative study of the pharmacokinetic/pharmacodynamic and safety profiles of ibuprofen extended release, ibuprofen regular release and placebo during a 12 hour observation in post-extraction dental pain |
Active substance: IBUPROFEN AND PSEUDOEPHEDRINE |
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Document reference: 29681 |
Study title: Uptake pharmacokinetics of the Fentanyl Oralet in children scheduled for central venous access removal: implications for the timing of initiating painful procedures; Paediatr Anaesth 2002, 12(7):594-9 |
Active substance: FENTANYL |
Study summary document link (including results): |
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Document reference: 27190 |
Study title: "Weir-J-H. Prazepam in the treatment of anxiety: a placebo-controlled multicenter evaluation. The Journal of clinical psychiatry, {J-Clin-Psychiatry}, Dec 1978, vol. 39, no. 12, p. 841-7, ISSN: 0160-6689. " "Weir-J-H. Prazepam in the treatment of anxiety: a placebo-controlled multicenter evaluation. The Journal of clinical psychiatry, {J-Clin-Psychiatry}, Dec 1978, vol. 39, no. 12, p. 841-7, ISSN: 0160-6689. " |
Active substance: PRAZEPAM |
Study summary document link (including results): |
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Document reference: 34644 |
Study title: Study the absorption of different salts of pc-V in syrup form and also to investigate whether gastrointestinal diseases, leading to malabsorption affects the absorption of pc in varying rates for different salts.Bolme et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_8.xlsx |
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Document reference: 49039 |
Study title: Study the effects of a twice a day dosage of potassium penicillin G, instead of three times a day.Vann et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_9.xlsx |
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Document reference: 49040 |
Study title: To evaluate the efficacy and safety of penicillin V in the treatment of acute tonsillitis in adults, when given as two or three daily doses.Mosbaek et al |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Phenoyxmethyl penicillin_16.xlsx |
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Document reference: 49047 |
Study title: Permanent junctional reciprocating tachycardia in children: a multicentre study on clinical profile and outcome.Vaksmann G, D−Hoinne C, Lucet V, Guillaumont S, Lupoglazoff JM, Chantepie A, Heart , Jan 2006 (epub: 14 Apr 2005) , vol. 92, no. 1, p. 101−4, Permanent junctional reciprocating tachycardia in children: a multicentre study on clinical profile and outcome.Vaksmann G, D−Hoinne C, Lucet V, Guillaumont S, Lupoglazoff JM, Chantepie A, Heart , Jan 2006 (epub: 14 Apr 2005) , vol. 92, no. 1, p. 101−4, |
Active substance: VERAPAMIL |
Study summary document link (including results): |
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Document reference: 45534 |
Study title: Prevention of atrial fibrillation after cardioversion: results of the PAFAC trial.Fetsch T, Bauer P, Engberding R, Koch−Hans P, Lukl J, Meinertz T, Oeff M, Seipel L, Trappe−Hans J, Treese N , Breithardt G. European heart journal, Aug 2004, vol. 25, no. 16, p. 1385−94, Prevention of atrial fibrillation after cardioversion: results of the PAFAC trial.Fetsch T, Bauer P, Engberding R, Koch−Hans P, Lukl J, Meinertz T, Oeff M, Seipel L, Trappe−Hans J, Treese N , Breithardt G. European heart journal, Aug 2004, vol. 25, no. 16, p. 1385−94, |
Active substance: VERAPAMIL |
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Document reference: 45536 |
Study title: Superiority of lithium over verapamil in mania: a randomized, controlled, single−blind trial.Walton SA, Berk M, Brook S. The Journal of clinical psychiatry, Nov 1996, vol. 57, no. 11, p. 543−6, Superiority of lithium over verapamil in mania: a randomized, controlled, single−blind trial.Walton SA, Berk M, Brook S. The Journal of clinical psychiatry, Nov 1996, vol. 57, no. 11, p. 543−6, |
Active substance: VERAPAMIL |
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Document reference: 45544 |
Study title: Swiss hypertension treatment programme with verapamil and/or enalapril in diabetic patients.Ferrier C, Ferrari P, Weidmann P, Keller U, Beretta PC, Riesen WF. Drugs, 1992, vol. 44 Suppl 1, p. 74−84,Swiss hypertension treatment programme with verapamil and/or enalapril in diabetic patients.Ferrier C, Ferrari P, Weidmann P, Keller U, Beretta PC, Riesen WF. Drugs, 1992, vol. 44 Suppl 1, p. 74−84, |
Active substance: VERAPAMIL |
Study summary document link (including results): |
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Document reference: 45553 |
Study title: Traitement médical de la myocardiopathie hypertrophique. Comparaison entre le propranolol et le vérapamil. (Medical treatment of hypertrophic myocardiopathy. Comparison of propranolol and verapamil).Bouhour JB, Potiron M, Chiffoleau S, Lefévre M, Louvet S. Archives des maladies du coeur et des vaisseaux, Jan 1987, vol. 80, no. 1, p. 76−82, Traitement médical de la myocardiopathie hypertrophique. Comparaison entre le propranolol et le vérapamil. (Medical treatment of hypertrophic myocardiopathy. Comparison of propranolol and verapamil).Bouhour JB, Potiron M, Chiffoleau S, Lefévre M, Louvet S. Archives des maladies du coeur et des vaisseaux, Jan 1987, vol. 80, no. 1, p. 76−82, |
Active substance: VERAPAMIL |
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Document reference: 45563 |
Study title: Uso del verapamil nel trattamento dell'emicrania senza aura. (The use of verapamil in the treatment of hemicrania without aura).Fonzari M, Santoloci D, Farinini D. La Clinica terapeutica, Apr 1994, vol. 144, no. 4, p. 329−32, Uso del verapamil nel trattamento dell'emicrania senza aura. (The use of verapamil in the treatment of hemicrania without aura).Fonzari M, Santoloci D, Farinini D. La Clinica terapeutica, Apr 1994, vol. 144, no. 4, p. 329−32, |
Active substance: VERAPAMIL |
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Document reference: 45549 |
Study title: Valutazione degli effetti indotti dall'uso di verapamile, flunarizina, diltiazem, nimodipina e placebo nella profilassi dell'emicrania. Studio a doppio cieco randomizzato cross−over. (Evaluation of the effects of verapamil, flunarizine, diltiazem, nimodipine and placebo in the prevention of hemicrania. A double−blind randomized cross−over study).Paterna S, Martino SG, Campisi D, Cascio IN, Marsala BA. La Clinica terapeutica, 31 Jul 1990, vol. 134, no. 2, p. 119−25, Valutazione degli effetti indotti dall'uso di verapamile, flunarizina, diltiazem, nimodipina e placebo nella profilassi dell'emicrania. Studio a doppio cieco randomizzato cross−over. (Evaluation of the effects of verapamil, flunarizine, diltiazem, nimodipine and placebo in the prevention of hemicrania. A double−blind random... |
Active substance: VERAPAMIL |
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Document reference: 45557 |
Study title: Effect of early immunomodulator use in moderate to severe pediatric Crohn disease.Punati J, Markowitz J, Lerer T, Hyams J, Kugathasan S, Griffiths A, Otley A, Rosh J, Pfefferkorn M, Mack D, Evans J, Bousvaros A, Moyer MS, Wyllie R, Oliva-Hemker M, Mezoff A, Leleiko N, Keljo D, Crandall W; Pediatric IBD Collaborative Research Group. Inflamm Bowel Dis. 2008 Jul;14(7):949-54 |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49284 |
Study title: Follow-up of children with autoimmune hepatitis treated with cyclosporine.Cuarterolo M, Ciocca M, Velasco CC, Ramonet M, González T, López S, Garsd A, Alvarez F. J Pediatr Gastroenterol Nutr. 2006 Nov;43(5):635-9. |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49277 |
Study title: Heart transplantation in patients with previous Fontan operations.Gamba A1, Merlo M, Fiocchi R, Terzi A, Mammana C, Sebastiani R, Ferrazzi P. J Thorac Cardiovasc Surg. 2004 Feb;127(2):555-62. |
Active substance: Azathioprine |
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Document reference: 49261 |
Study title: Decroix J, et al Oral itraconazole in the treatment of dermatomycosis. A multicenter evaluation of different treatment schedules. Clinical summary on R51211, August 1987. (10-86 years, LMD56447)Decroix J, et al Oral itraconazole in the treatment of dermatomycosis. A multicenter evaluation of different treatment schedules. Clinical summary on R51211, August 1987. (10-86 years, LMD56447) |
Active substance: ITRACONAZOLE |
Study summary document link (including results): |
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Document reference: 30789 |
Study title: A Randomized, Multicenter Masked Comparison Trial of Poractant Alfa (Curosurf) versus Beractant (Survanta) in the Treatment of Respiratory Distress Syndrome in Preterm InfantsRangasamy Ramanathan, |
Active substance: PORACTANT ALFA |
Study summary document link (including results): DL-032 publication.pdf |
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Document reference: 49238 |
Study title: Follow up on Infants Treated with Porcine Surfactant Replacement for Severe Neonatal and Infant Respiratory Distress Syndrome: Antigenic Reactivity Evaluation(Marraro G.) |
Active substance: PORACTANT ALFA |
Study summary document link (including results): 50.01-CT-02-93 publication.pdf |
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Document reference: 49232 |
Study title: Low bone mineral density in children and adolescents with inflammatory bowel disease: a population-based study from Western Sweden.Schmidt S, Mellström D, Norjavaara E, Sundh SV, Saalman R. Inflamm Bowel Dis. 2009 Dec;15(12):1844-50 |
Active substance: Azathioprine |
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Document reference: 49290 |
Study title: Multicentre prospective randomised trial of tacrolimus, azathioprine and prednisolone with or without basiliximab: two-year follow-up data.Webb NJ, Prokurat S, Vondrak K, Watson AR, Hughes DA, Marks SD, Moghal NE, Fitzpatrick MM, Milford DV, Saleem MA, Jones CA, Friman S, Van Damme-Lombaerts R, Janssen F, Hamer C, Rhodes S. Pediatr Nephrol. 2009 Jan;24(1):177-82 |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49286 |
Study title: Kremens B et al, High-dose consolidation with local radiation and bone marrow rescue in patients with advanced neuroblastoma, Med Pediatr Oncol. 1994;23(6):470-5 |
Active substance: ETOPOSIDE |
Study summary document link (including results): |
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Document reference: 26950 |
Study title: In vitro generation of cytotoxic effectors activated by interleukin 2 (IL-2): Comparison of autologous peripheral blood stem cells (PBSC) from adults and children. Valteau-Couanet D et al. Bone Marrow Transplant June. 13, 2001, 869-75 |
Active substance: FLUOROURACIL |
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Document reference: 28274 |
Study title: A 3-week, open -label, uncontrolled, multicenter study evaluating the functionality of the Foradil Certihaler device in Patients with asthma |
Active substance: FORMOTEROL |
Study summary document link (including results): |
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Document reference: 47800 |
Study title: An open-labeled study evaluating the safety and efficacy of growth hormone therapy in short children with chronic renal insufficiency |
Active substance: Somatropin |
Study summary document link (including results): 91-003 and 91-004 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 41709 |
Study title: Oral tacrolimus treatment of severe colitis in children.Bousvaros A1, Kirschner BS, Werlin SL, Parker-Hartigan L, Daum F, Freeman KB, Balint JP, Day AS, Griffiths AM, Zurakowski D, Ferry GD, Leichtner AM. J Pediatr. 2000 Dec;137(6):794-9. |
Active substance: Azathioprine |
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Document reference: 49249 |
Study title: Outcome of pediatric renal transplants in a developing country.Gulati S, Kumar A, Sharma RK, Gupta A, Bhandari M, Kumar A, Srivastava A. Pediatr Nephrol. 2004 Jan;19(1):96-100 |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49260 |
Study title: Premature atherosclerosis in pediatric systemic lupus erythematosus: risk factors for increased carotid intima-media thickness in the atherosclerosis prevention in pediatric lupus erythematosus cohort.Schanberg LE, Sandborg C, Barnhart HX, Ardoin SP, Yow E, Evans GW, Mieszkalski KL, Ilowite NT, Eberhard A, Levy DM, Kimura Y, von Scheven E, Silverman E, Bowyer SL, Punaro L, Singer NG, Sherry DD, McCurdy D, Klein-Gitelman M, Wallace C, Silver R, Wagner-Weiner L, Higgins GC, Brunner HI, Jung L, Soep JB, Reed A; Atherosclerosis Prevention in Pediatric Lupus Erythematosus Investigators. Arthritis Rheum. 2009 May;60(5):1496-507 |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49289 |
Study title: Prospective randomized trial of azathioprine in cryopreserved valved allografts in children.Shaddy RE1, Lambert LM, Fuller TC, Profaizer T, Thompson DD, Baker SI, Osborne KA, Hawkins JA. Ann Thorac Surg. 2001 Jan;71(1):43-7; discussion 47-8. |
Active substance: Azathioprine |
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Document reference: 49250 |
Study title: Short-term cyclosporine induces a remission of autoimmune hepatitis in children.Alvarez F, Ciocca M, Cañero-Velasco C, Ramonet M, de Davila MT, Cuarterolo M, Gonzalez T, Jara-Vega P, Camarena C, Brochu P, Drut R, Alvarez E. J Hepatol. 1999 Feb;30(2):222-7. |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49226 |
Study title: Evaluation of the efficacy and tolerance of RU51807 (cefpodoxime proxetil) in children with skin and soft tissue infections |
Active substance: CEFPODOXIME |
Study summary document link (including results): CEFPODOXIME STUDY FF8980740.xls |
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Document reference: 47975 |
Study title: Study the therapeutic action (control and prevention fo asthma attacks) and safety of Triamcinolone hexacetonide in 60 ambulatory patients exhibiting asthma, by means of a trial in which it would be compared with other steroids.Valdés |
Active substance: TRIAMCINOLONE |
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Document reference: 48965 |
Study title: Open, phase IIIb multicentric study of the immunogenicity and reactogenicity of the co-administration of Priorix (measles-mumps-rubella) and Infanrix Polio-Hib in each thigh to healthy infants aged 16 to 20 months. |
Active substance: trivalent attenuated measles (Schwarz strain) - mumps (RIT 4385 and RIT 4386) - rubella (RA 27/3 strain) |
Study summary document link (including results): |
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Document reference: 47872 |
Study title: Saletu, B., Simeon, J., Saletu, M., Itil, T. M., and DaSilva, J. Behavioral and visual evoked potential investigations during trihexyphenidyl and thiothixene treatment in psychotic boys Biol.Psychiatry 1974;8:177-189. Saletu, B., Simeon, J., Saletu, M., Itil, T. M., and DaSilva, J. Behavioral and visual evoked potential investigations during trihexyphenidyl and thiothixene treatment in psychotic boys Biol.Psychiatry 1974;8:177-189. |
Active substance: ORPHENADINE |
Study summary document link (including results): |
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Document reference: 32900 |
Study title: A multicentre double-blind group comparative study of the efficacy and safety of nedocromil sodium 2% ophthalmic solution in the treatment of Ragweed- induced seasonal allergic conjunctivitis - Melamed et al. - 1986 - Application for marketing autorisation - TILAVIST (Nedocromil Sodium 2% Eye drops) - Clinical documentation - OP Van Bijsterveld - 07/04/1993 - |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 46990 |
Study title: Am J Cardiol. 1996 Jul 15;78(2):175-81. Evaluation of myocardial ischemia and infarction by signal-averaged electrocardiographic late potentials in children with Kawasaki disease. Ogawa S, Nagai Y, Zhang J, Yuge K, Hino Y, Jimbo O, Fukazawa R, Hayashi RAm J Cardiol. 1996 Jul 15;78(2):175-81. Evaluation of myocardial ischemia and infarction by signal-averaged electrocardiographic late potentials in children with Kawasaki disease. Ogawa S, Nagai Y, Zhang J, Yuge K, Hino Y, Jimbo O, Fukazawa R, Hayashi R |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44508 |
Study title: Ianovskaia EM, Torbenko VP, Mironov SP, Riazantseva VI. [A radionuclide method used in post-traumatic stiffness of the elbow joint] Khirurgiia (Mosk). 1988 Dec;(12):117-9. Russian. No abstract available. Ianovskaia EM, Torbenko VP, Mironov SP, Riazantseva VI. [A radionuclide method used in post-traumatic stiffness of the elbow joint] Khirurgiia (Mosk). 1988 Dec;(12):117-9. Russian. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43802 |
Study title: Strenge-Hesse Postmarkting surveillance study (evaluation of 154 Legalon-SIL-case reports,18 children) 1983-1992 Internal Report; Cesko-Slovenska Pediatrie; VOL: 61 (6); p. 350-356 /2006/Internal Report, Strenge-Hesse, March 1996 |
Active substance: Silibinine dihydrogen succinate, disodium |
Study summary document link (including results): |
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Document reference: 39873 |
Study title: A fluoride dose response evaluation in an anticaries clinical trial1992-Marks, J Dent Res(71)6:1286-1291, June 1992 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): 1992-Marks-a fluoride dose response evaluation in an anticaries clinical trial.pdf |
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Document reference: 49086 |
Study title: The replacement of azathioprine by mycophenolate mofetil in pediatric patients with specific risks in renal transplantation.Anguita A, Repetto HA, Rodriguez-Rilo L, Vazquez LA, Iturzaeta A, Morrone G, Deheza R, Maldonado L, Goldberg JL. Transplant Proc. 1999 Sep;31(6):2279. |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49230 |
Study title: Treatment of small vessel primary CNS vasculitis in children: an open-label cohort study.Hutchinson C, Elbers J, Halliday W, Branson H, Laughlin S, Armstrong D, Hawkins C, Westmacott R, Benseler SM. Lancet Neurol. 2010 Nov;9(11):1078-84 |
Active substance: Azathioprine |
Study summary document link (including results): |
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Document reference: 49295 |
Study title: Valor profilactico de la vitamina C en infecciones respiratorias agudas del escolar. (Prophylactic value of vitamin C in acute respiratory tract infections in schoolchildren.)Bancalari A, Seguel C, Neira F, et al., 1984, Rev Med Chil. 1984;112(9):871-6 |
Active substance: ASCORBIC ACID |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48908 |
Study title: Valor profilactico de la vitamina C en infecciones respiratorias agudas del escolar. (Prophylactic value of vitamin C in acute respiratory tract infections in schoolchildren.)Bancalari A, Seguel C, Neira F, et al., 1984, Rev Med Chil. 1984;112(9):871-6 |
Active substance: ASCORBIC ACID |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48909 |
Study title: Analyse critique des études cliniques Abbott, contains study 75-030 of Depakene syrup in epileptic children - Canlorbe P. - 03/04/1981 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45447 |
Study title: Evaluate the prophylactic efficacy of trimetoprim in urinary tract infections and its effect on the normal gastrointestinal and periurethral bacterial flora.Lidin-Janson et al |
Active substance: TRIMETHOPRIM |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Trimetoprim_3.xlsx |
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Document reference: 49061 |
Study title: Comparison of nebulized beclomethasone dipropionate and nebulized budesonide in asthma of infants and children. Multicentre, randomized, controlled, open-label study versus reference product in 2 parallel groups over 14 weeks including a 2-week run-in, in severe or persistent asthma in infants and young children of the equivalent safety and efficacy of the addition, to the usual maintenance treatment, of 800 mg of nebulized beclomethasone dipropionate or 750mg of nebulized Pulmicort® twice a day.study synopsis. Please see report |
Active substance: BECLAMETHASONE |
Study summary document link (including results): 14.06.CT.01.91 (Synopsis).doc |
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Document reference: 49206 |
Study title: Safety and efficacy comparison of two dosing regimens of MetroGel-Vaginal(R) in the treatment of bacterial vaginosis: a multicenter, randomized, single-blind, parallel comparison.Soper DE1, Livengood C, Sheehan KL, Fenner DE, Martens MG, Nelson AL, Ismail M, Thorp JM, Lappin M, Fleury FJ, Long BJ, Blackwelder T, Sweet RL, Sagov S. Prim Care Update Ob Gyns. 1998 Jul 1;5(4):150. |
Active substance: METRONIDAZOLE |
Study summary document link (including results): |
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Document reference: 48942 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Mezereum-Homaccord (drops) [AWB-AT] |
Active substance: Mezereum-Homaccord |
Study summary document link (including results): |
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Document reference: 40071 |
Study title: Miser JS et al. Treatment of metastatic Ewing's sarcoma or primitive neuroectodermal tumor of bone: evaluation of combination ifosfamide and etoposide--a Children's Cancer Group and Pediatric Oncology Group study.J Clin Oncol. 2004 Jul 15;22(14):2873-6.Miser JS et al. Treatment of metastatic Ewing's sarcoma or primitive neuroectodermal tumor of bone: evaluation of combination ifosfamide and etoposide--a Children's Cancer Group and Pediatric Oncology Group study.J Clin Oncol. 2004 Jul 15;22(14):2873-6. |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32177 |
Study title: Comparative Evaluation of Cefixime versus Amoxicillin-Clavulate Following Ceftriaxone Therapy of PneumoniaClin Pediatr 1996; 35: 629-633, Amir J., 1996 |
Active substance: CEFIXIME |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48974 |
Study title: Comparative Evaluation of Cefpodoxime Versus Cefixime in children with Lower Respiratory Tract InfectionsIndian J Pediatr 2004; 71: 517-521 Sengupta J. |
Active substance: CEFIXIME |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48975 |
Study title: Application of S-CMC to otitis media with effusion. - Yukiko Ito et al.- 1992 (Journal reference not readable, 85:5;815-819) ; Publication M90 French validation registration dossier 05/1995 |
Active substance: CARBOCYSTEINE |
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Document reference: 23308 |
Study title: Dissociation of platelet activation and spontaneous myocardial ischemia in unstable angina. Vejar M, Fragasso G, Hackett D, Lipkin DP, Maseri A, Born GV, Ciabattoni G, Patrono C. Thrombosis and haemostasis, 12 Apr 1990, vol. 63, no. 2, p. 163−8Dissociation of platelet activation and spontaneous myocardial ischemia in unstable angina. Vejar M, Fragasso G, Hackett D, Lipkin DP, Maseri A, Born GV, Ciabattoni G, Patrono C. Thrombosis and haemostasis, 12 Apr 1990, vol. 63, no. 2, p. 163−8 |
Active substance: DILTIAZEM |
Study summary document link (including results): |
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Document reference: 26148 |
Study title: Bisoprolol treatment in children with hyperkinetic heart syndromeEur J Echocardiography 1999; Suppl: S66, Jurko A., 1999 |
Active substance: Bisoprolol |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48905 |
Study title: β-Blocker/thiazide combination for treatment of hypertensive children: a randomized double-blind, placebo-controlled trial.Pediatr Nephrol 2002; 17: 345-350; Sorof JM., 2002 |
Active substance: BISOPROLOL AND HYDROCHLOROTHIAZIDE |
Study summary document link (including results): 20140709_Art 45 Studies.xlsx |
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Document reference: 48907 |
Study title: Neurology. 1995 Jan;45(1):123-6. FDG-PET and volumetric MRI in the evaluation of patients with partial epilepsy. Gaillard WD, Bhatia S, Bookheimer SY, Fazilat S, Sato S, Theodore WH. |
Active substance: FLUDEOXYGLUCOSE |
Study summary document link (including results): |
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Document reference: 28201 |
Study title: Double-blind evaluation of effectiveness and safety of flunisolide aerosol for treatment of bronchial asthma in children.Piacentini G.L. et al, Allergy 1990,45, 612-616 |
Active substance: FLUNISOLIDE |
Study summary document link (including results): Published paper (Piacentini).pdf |
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Document reference: 49212 |
Study title: A Double blind, placebo-controlled trial for further evaluation of the effect of these preparations in migraine and also of their side-effects.Kallós et al. (Translation of a paper from The Swedish Medical journal (Svenska Läkartidningen) 1958:55:1782 No. 24) |
Active substance: ergotamine |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ergotamine_1.xlsx |
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Document reference: 49073 |
Study title: Comparisons of the effect of ergotamine tartrate adminislered intramuscularly, by inhalation (Medihaler ergotamine) or rectally in combination with meprobamate, chlorcyc1izine, and caffeine (Anervan suppositories ):t, in the treatment of migraine attacks.Kallós et al. REPRINTED FROM HEADACHE, October, 1964 |
Active substance: ergotamine |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Ergotamine_2.xlsx |
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Document reference: 49074 |
Study title: Double-blinded, randomized trial to evaluate the efficacy of early erythromycin treatment on the duration of fecal excretion and diarrhea associated with Campylobacter jejuni.Salazar-Lindo et al. (The Journal Of Pediatrics, Aug, 1986) |
Active substance: ERYTHROMYCIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_6.xlsx |
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Document reference: 49054 |
Study title: Examine the variability in erythromycin pharmacokinetics after single dose intravenous administration, determine the linearity of pharmacokinetic parameters after administration of different doses, evaluate the usefulness of non-invasive sampling techniques in studying erythromycin pharmacokinetics.Klaustin et al. (Br. J. Am. Pharmac. 1980, 273-279) |
Active substance: ERYTHROMYCIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_7.xlsx |
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Document reference: 49055 |
Study title: CLINICAL EVALUATION OF FLUCONAZOLE (UK-49,858) IN IV DRIP ENJECTION FROM EFFICACY AND SAFETY IN PEDIATRIC SYSTEMIC MYCOSIS. |
Active substance: FLUCONAZOLE |
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Document reference: 27933 |
Study title: A comparative study of Fucidin H cream and Hydrocortisone cream in children (4-17 years) with a flare-up of atopic dermatitis. A study using non-invasive bioengineering techniques. |
Active substance: FRAMYCETIN |
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Document reference: 28625 |
Study title: An open uncontrolled study to evaluate the effect of treatment and tolerance of a flucloxacillin nsyrup.Price et al Flucloxacillin in the treatment of infectious conditions in children. |
Active substance: FLUCLOXACILLIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Flukloxacillin_1.xlsx |
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Document reference: 49076 |
Study title: Investigate the bioavailability of 2 commercially available pediatric suspensions of erythromycin containing the stearate salt and the ethylsuccinate ester, respectively.Eriksson et al. (Scand J Infcect Dis 13: 211-215, 1981) |
Active substance: ERYTHROMYCIN |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Erythomycin ethylsuccinate_9.xlsx |
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Document reference: 49057 |
Study title: To determine the apparent bioavailability of Dicloxacillin in children of ages ranging from 6 days to 11,5 years.Smith et al. (Dev Pharmacol Ther 1990;14:35-44) |
Active substance: dicloxacillin |
Study summary document link (including results): EUdraCT_reduced datafields for Interim publication Recip_Dikloxacillin_1.xlsx |
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Document reference: 49078 |
Study title: A modified schedule for routine pertussis immunization |
Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
Study summary document link (including results): |
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Document reference: 40996 |
Study title: A phase II, double blind, randomized, double center, controlled study to evaluate the safety and immunogenicity of four formulations of DTwPHib combined vaccine containing different concentrations of Hib conjugate in healthy infants at 3, 4, 5 months of age.Please see report- sturdy report |
Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
Study summary document link (including results): V45P1.xlsx |
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Document reference: 49183 |
Study title: A phase II, open-label, randomized, single-center, comparative study evaluating safety, tolerability and immunogenicity of three vaccinations of the DTPHib combined vaccine (Chiron Vaccines; now Novartis Vaccines) in comparison to separate vaccinations of DTP (Chiron Behring; now Novartis Vaccines) and Hib/AlPO4 (Chiron Vaccines; now Novartis Vaccines) vaccines, when administered to 2, 3, 4 months old healthy infants.Please see report- sturdy report |
Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
Study summary document link (including results): V38P1.xlsx |
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Document reference: 49186 |
Study title: A phase II, open-label, single-centre, singal-arm, extension study to evaluate the safety and immunogenicity of a booster vaccination of the DTPHib combined vaccine (Chiron Vaccines; now Novartis Vaccines) administered to 18-20 months old healthy infants who had previously received either DTPHib combined vaccine or separate administrations of DTP (Chiron Behring; now Novartis Vaccines) and Hib/AlPO4 (Chiron Vaccines; now Novartis Vaccines) vaccines at 2, 3 and 4 months of age.Please see report- sturdy report |
Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
Study summary document link (including results): V38P1E1.xlsx |
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Document reference: 49185 |
Study title: Weiner-M-A, Leventhal-B-G, Marcus-R, Brecher-M, Ternberg-J, Behm-F-G, Cantor-A, Wharam-M, Chauvenet-A. Hackensack Medical Center, NJ. Intensive chemotherapy and low-dose radiotherapy for the treatment of advanced-stage Hodgkin's disease in pediatric patients: a Ped iatric Oncology Group study. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Sep 1991, vol. 9, no. 9, p. 1591-8, ISSN: 0732-183X.Weiner-M-A, Leventhal-B-G, Marcus-R, Brecher-M, Ternberg-J, Behm-F-G, Cantor-A, Wharam-M, Chauvenet-A. Hackensack Medical Center, NJ. Intensive chemotherapy and low-dose radiotherapy for the treatment of advanced-stage Hodgkin's disease in pediatric patients: a Ped iatric Oncology Group study. Journal of clinical oncology ... |
Active substance: PROCARBAZINE |
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Document reference: 34875 |
Study title: Corrias A et al. GH/IGF-I axis in Prader-Willi syndrome: evaluation of IGF-I levels and of the somatotroph responsiveness to various provocative stimuli. Genetic Obesity Study. Group of Italian Society of Pediatric Endocrinology and Diabetology. J Endocrinol Invest. 2000 Feb;23(2):84-9Corrias A et al. GH/IGF-I axis in Prader-Willi syndrome: evaluation of IGF-I levels and of the somatotroph responsiveness to various provocative stimuli. Genetic Obesity Study. Group of Italian Society of Pediatric Endocrinology and Diabetology. J Endocrinol Invest. 2000 Feb;23(2):84-9 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35190 |
Study title: Bozzo TM. The Effect of Encephabol in School Children with States of Mental Exhaustion (Minerva Medicopsicologica 1970; 2 (12): 44-47)Bozzo TM. The Effect of Encephabol in School Children with States of Mental Exhaustion (Minerva Medicopsicologica 1970; 2 (12): 44-47) |
Active substance: PYRITINOL |
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Document reference: 35240 |
Study title: Kynclova S, Mydlil S Presented at the Czechoslovakian Symposium on Isoprinosine®; October, 1989; Prague. (Abstract only). First experience with Isoprinosine®/Modimunal® treatment in childrenKynclova S, Mydlil S Presented at the Czechoslovakian Symposium on Isoprinosine®; October, 1989; Prague. (Abstract only). First experience with Isoprinosine®/Modimunal® treatment in children |
Active substance: INOSINE |
Study summary document link (including results): |
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Document reference: 30135 |
Study title: Lento FG, Baretti C, Salemo R, Tandurella S.. Vittorio Emanuele III Hospital, Gela, Italy. 1980. Clinical Study Report . Treatment of varicella and measles with methisoprinolLento FG, Baretti C, Salemo R, Tandurella S.. Vittorio Emanuele III Hospital, Gela, Italy. 1980. Clinical Study Report . Treatment of varicella and measles with methisoprinol |
Active substance: INOSINE |
Study summary document link (including results): |
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Document reference: 30136 |
Study title: Lento FG, Cannata G, Baretti C, Salemo R, Tandurella S.. Clinica Europea. Nov-Dec 1981;20(6):3-8. Preliminary results obtained with methisoprinol in the treatment of measles and varicellaLento FG, Cannata G, Baretti C, Salemo R, Tandurella S.. Clinica Europea. Nov-Dec 1981;20(6):3-8. Preliminary results obtained with methisoprinol in the treatment of measles and varicella |
Active substance: INOSINE |
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Document reference: 30137 |
Study title: Study of intravenous Diprivan (propofol) to determine an effective dose when used as an induction agent in pediatric patients undergoing various surgical procedures |
Active substance: PROPOFOL |
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Document reference: 46122 |
Study title: Study of intravenous Diprivan (propofol) to determine an effective dose when used as an induction agent in pediatric patients undergoing various surgical procedures under one hour duration |
Active substance: PROPOFOL |
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Document reference: 46123 |
Study title: The pharmacokinetics of Diprivan (propofol) in pediatric patients |
Active substance: PROPOFOL |
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Document reference: 46121 |
Study title: The safety of Diprivan (propofol) anesthesia versus standard anesthetic techniques in pediatric subjects less than 36 months of age |
Active substance: PROPOFOL |
Study summary document link (including results): 0859US0046 Study Synopsis.pdf |
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Document reference: 46126 |
Study title: The safety, efficacy and pharmacokinetics of ZD0859#1 vs. Diprivan (propofol) injection when used for maintenance of anaesthesia in children. |
Active substance: PROPOFOL |
Study summary document link (including results): 0859IL0058 Study Synopsis.pdf |
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Document reference: 46136 |
Study title: Therapeutic equivalence of a deep propofol sedation in children aged 1 month to 8 years undergoing magnet resonance imaging |
Active substance: PROPOFOL |
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Document reference: 46120 |
Study title: Tolerability of Propofol Braun 1% compared with Disoprivan 1% |
Active substance: PROPOFOL |
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Document reference: 46119 |
Study title: Codispoti M, Mankad PS: Management of anticoagulation and its reversal during paediatric cardiopulmonary bypass: a review of current UK practice. Perfusion 2000; 15: 191-201 Codispoti M, Mankad PS: Management of anticoagulation and its reversal during paediatric cardiopulmonary bypass: a review of current UK practice. Perfusion 2000; 15: 191-201 |
Active substance: PROTAMINE |
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Document reference: 35086 |
Study title: Effect of different doses of protamine in cyanotic and acyonotic children in congenital heart surgery. Bayrak H et al. Gogus-Kalp-Damar Anestezi ve Yogun Bakim Dernegi Dergisi ( Gogus-Kalp-Damar Anestezi Yogun Bakim Dernegi Derg. ) (Turkey) , March 1, 2007 , 13/1 (24-30) Effect of different doses of protamine in cyanotic and acyonotic children in congenital heart surgery. Bayrak H et al. Gogus-Kalp-Damar Anestezi ve Yogun Bakim Dernegi Dergisi ( Gogus-Kalp-Damar Anestezi Yogun Bakim Dernegi Derg. ) (Turkey) , March 1, 2007 , 13/1 (24-30) |
Active substance: PROTAMINE |
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Document reference: 35084 |
Study title: Efficacy of sucrose to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Gal P, Kissling GE, Young WO, Dunaway KK, Marsh VA, Jones SM, Shockley DH, Weaver NL, Carlos RQ, Ransom JL. Ann Pharmacother. 2005 Jun;39(6):1029-33;Epub 2005 Apr 26. 2. Efficacy of sucrose to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Gal P, Kissling GE, Young WO, Dunaway KK, Marsh VA, Jones SM, Shockley DH, Weaver NL, Carlos RQ, Ransom JL. Ann Pharmacother. 2005 Jun;39(6):1029-33;Epub 2005 Apr 26. 2. |
Active substance: PROXYMETHACAINE |
Study summary document link (including results): Efficacy of sucrose to reduce pain in premature infants.pdf |
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Document reference: 46139 |
Study title: Efficacy of topical anesthetics to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Marsh VA, Young WO, Dunaway KK, Kissling GE, Carlos RQ, Jones SM, Shockley DH, Weaver NL, Ransom JL, Gal P. Ann Pharmacother. 2005 May;39(5):829-33;Epub 2005 Mar 29. Efficacy of topical anesthetics to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Marsh VA, Young WO, Dunaway KK, Kissling GE, Carlos RQ, Jones SM, Shockley DH, Weaver NL, Ransom JL, Gal P. Ann Pharmacother. 2005 May;39(5):829-33;Epub 2005 Mar 29. |
Active substance: PROXYMETHACAINE |
Study summary document link (including results): Efficacy of topical anesthetics to reduce pain in premature .pdf |
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Document reference: 46140 |
Study title: Acad Radiol. 1996 Sep;3 Suppl 3:S524-7. Comparison of iodixanol with iohexol in excretory urography. Siegle RL, Gavant ML. Acad Radiol. 1996 Sep;3 Suppl 3:S524-7. Comparison of iodixanol with iohexol in excretory urography. Siegle RL, Gavant ML. |
Active substance: IODIXANOL |
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Document reference: 30348 |
Study title: Complications with Outpatient Angiography and Interventional ProceduresYoung N 2002. Cardiovasc Intervent Radiol (2002) 25:123–126 |
Active substance: IODIXANOL |
Study summary document link (including results): 2011-09 GE Visipaque response List of published articles.doc |
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Document reference: 48199 |
Study title: 56. Vazquez, Encarna-cion, Sem Med Mex 1963; 39: 179-181 56. Vazquez, Encarna-cion, Sem Med Mex 1963; 39: 179-181 |
Active substance: PYRVINIUM |
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Document reference: 39585 |
Study title: A STUDY OF PHARMACOKINETICS OF QUINAPRIL IN PEDIATRIC PATIENTS |
Active substance: QUINAPRIL |
Study summary document link (including results): 0906-000-434 EMEA Pediatrics Web Synopsis.pdf |
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Document reference: 45056 |
Study title: AN 8-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO DETERMINE THE SAFETY AND EFFICACY OF QUINAPRIL IN PEDIATRIC PATIENTS WITH HYPERTENSION |
Active substance: QUINAPRIL |
Study summary document link (including results): 0906-427 EMEA Pediatrics Web Synopsis.pdf |
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Document reference: 45057 |
Study title: Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline (GSK) Biologicals’ RIT’s rec-DNA hepatitis B vaccine (10 mg) injected with or without hepatitis B immunoglobulin (HBIg) in newborns of HBeAg+ mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
Study summary document link (including results): |
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Document reference: 47767 |
Study title: Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline (GSK) Biologicals’ RIT’s rec-DNA hepatitis B vaccine (10 ıg) injected with orwithout hepatitis B immunoglobulin (HBIg) in newborns of HBeAg+ mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
Study summary document link (including results): |
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Document reference: 47768 |
Study title: Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline (GSK) Biologicals rec-DNA hepatitis B vaccine (10 mg) injected with or without hepatitis B immunoglobulin (HBIg) in newborns of HBeAg+ mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
Study summary document link (including results): |
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Document reference: 47754 |
Study title: Immunogenicity and protective efficacy of Smith Kline -RIT's rec-DNA hepatitis b vaccine (10mcg) in newborns of HBsAg positive or negative mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
Study summary document link (including results): |
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Document reference: 47766 |
Study title: Immunogenicity and protective efficacy of Smith Kline RIT's rec-DNA Hepatitis B vaccine in newborns of HbsAg positive or negative mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
Study summary document link (including results): |
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Document reference: 47757 |
Study title: Immunogenicity and protective efficacy of Smith Kline RIT's rec-DNA Hepatitis B vaccine in newborns of HbsAg positive or negative mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
Study summary document link (including results): |
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Document reference: 47758 |
Study title: Immunogenicity and protective efficacy of Smith Kline RIT's rec-DNA Hepatitis B vaccine in newborns of HbsAg positive or negative mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
Study summary document link (including results): |
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Document reference: 47759 |
Study title: Immunogenicity and protective efficacy of Smith Kline RIT's rec-DNA Hepatitis B vaccine in newborns of HbsAg positive or negative mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
Study summary document link (including results): |
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Document reference: 47760 |
Study title: Immunogenicity and protective efficacy of Smith Kline RIT's rec-DNA Hepatitis B vaccine in newborns of HbsAg positive or negative mothers. |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
Study summary document link (including results): |
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Document reference: 47761 |
Study title: Open, randomized study to evaluate the immunogenicity of Engerix®-B when administered according to a vaccination schedule of 0, 1 and 12 months to healthy adolescents at two different doses (10 µg vs 20 µg). |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
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Document reference: 47753 |
Study title: Paolucci-G, Vecchi-V, Rosito-P, Paolucci-P, Burnelli-R, Pession-A, Mancini-A-F, Vivarelli-F. Clinica Pediatrica III, Universita degli Studi, Via Massaren11, 40138 Bologna, Italy. New perspectives in pediatric oncology. Rivista Italiana di Pediatria {RIV-ITAL-PEDIATR}, 1991, Vol/Iss/Pg. 17/4 (475-487), ISSN: 0392-5161.Paolucci-G, Vecchi-V, Rosito-P, Paolucci-P, Burnelli-R, Pession-A, Mancini-A-F, Vivarelli-F. Clinica Pediatrica III, Universita degli Studi, Via Massaren11, 40138 Bologna, Italy. New perspectives in pediatric oncology. Rivista Italiana di Pediatria {RIV-ITAL-PEDIATR}, 1991, Vol/Iss/Pg. 17/4 (475-487), ISSN: 0392-5161. |
Active substance: PROCARBAZINE |
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Document reference: 34802 |
Study title: Papadakis-V, Vlachopapadopoulou-E, Van-Syckle-K, Ganshaw-L, Kalmanti- M, Tan-C, Sklar-C. Department of Pediatrics, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. Gonadal function in young patients successfully treated for Hodgkin disease. Medical and pediatric oncology, {Med-Pediatr-Oncol}, May 1999, vol. 32, no. 5, p. 366-72, ISSN: 0098-1532.Papadakis-V, Vlachopapadopoulou-E, Van-Syckle-K, Ganshaw-L, Kalmanti- M, Tan-C, Sklar-C. Department of Pediatrics, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. Gonadal function in young patients successfully treated for Hodgkin disease. Medical and pediatric oncology, {Med-Pediatr-Oncol}, May 1999, vol. 32, no. 5, p. 366-72, ISSN: 0098-1532. |
Active substance: PROCARBAZINE |
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Document reference: 34803 |
Study title: Clinical evaluation of R50547 eye drops on allergic conjunctivitis and vernal conjunctivitis. A sungle masked comparative study with Sodium Cromoglicate eye drops |
Active substance: LEVOCABASTINE |
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Document reference: 31066 |
Study title: Clinical laboratory data related to the safety of levocabastine eye drops and nasal spray. An evaluation based on 27 studies in 655 subjects (6-81 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD45257_Interventional_Levocabastine.xls |
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Document reference: 31071 |
Study title: Comparison of the effects of fluticasone propionate, aqueous nasal spray and levocabastine on inflammatory cells in nasal lavage and clinical activity during the pollen season in seasonal rhinitis. Clinical and Experimental Allergy 29, p. 1367-1 377, 1999Comparison of the effects of fluticasone propionate, aqueous nasal spray and levocabastine on inflammatory cells in nasal lavage and clinical activity during the pollen season in seasonal rhinitis. Clinical and Experimental Allergy 29, p. 1367-1 377, 1999 |
Active substance: LEVOCABASTINE |
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Document reference: 31118 |
Study title: Sackmann-Muriel-F, Diez-B, Schvartzman-E, et-al. Oncology Department, Hospital de Ninos, 1425 Buenos Aires, Argentina. Comparison of two consecutive trials for treatment of childhood non-Hodgkin's lymphoma. Cancer {CANCER}, 1984, Vol/Iss/Pg. 54/12 (2863-2868).Sackmann-Muriel-F, Diez-B, Schvartzman-E, et-al. Oncology Department, Hospital de Ninos, 1425 Buenos Aires, Argentina. Comparison of two consecutive trials for treatment of childhood non-Hodgkin's lymphoma. Cancer {CANCER}, 1984, Vol/Iss/Pg. 54/12 (2863-2868). |
Active substance: PROCARBAZINE |
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Document reference: 34821 |
Study title: Sackmann-Muriel-F. Unid. Hematol., Hosp. Ninos, Buenos Aires, Argentina. Recent advances in treatment of children with non-Hodgkin lymphoma. Revista del Hospital de Ninos {REV-HOSP-NINOS}, 1978, Vol/Iss/Pg. 20 /80 (156-161).Sackmann-Muriel-F. Unid. Hematol., Hosp. Ninos, Buenos Aires, Argentina. Recent advances in treatment of children with non-Hodgkin lymphoma. Revista del Hospital de Ninos {REV-HOSP-NINOS}, 1978, Vol/Iss/Pg. 20 /80 (156-161). |
Active substance: PROCARBAZINE |
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Document reference: 34823 |
Study title: A phase III, randomised, controlled, multicenter study in adults, investigating the antibody response to postexposure rabies vaccination combined with Human Rabies Immune Globuline (HRIG) between two types of tissue culture rabies vaccines, Purified vero cell rabies vaccine (PVRV) and Purified chick embryo cell rabies vaccine (PCECV) |
Active substance: RABIES VACCINE FOR HUMAN USE PREPARED FROM CELL CULTURE (DIPLOID CELLS) |
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Document reference: 48384 |
Study title: Evaluation of single agent rasburicase in treatment/ prevention of hyperuricemia associated with tumor lysis syndrome in adult and paediatric patients with lymphoma/ leukemia/solid tumor or malignancies at their first relapse or refractory disease |
Active substance: rasburicase |
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Document reference: 41509 |
Study title: Lokaj J, Wiedermannov, Litzman J. Presented at the Czechoslovakian Symposium on Isoprinosine®; October, 1989; Prague. (Abstract only). Importance of immunological laboratory examination while indicating and controlling treatment with Isoprinosine®/Modimunal®Lokaj J, Wiedermannov, Litzman J. Presented at the Czechoslovakian Symposium on Isoprinosine®; October, 1989; Prague. (Abstract only). Importance of immunological laboratory examination while indicating and controlling treatment with Isoprinosine®/Modimunal® |
Active substance: INOSINE |
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Document reference: 30143 |
Study title: An open label prospective study to observe the postmarketing safety of Euvax B Inj. |
Active substance: Recombinant DNA Hepatitis B Surface Antigen (HBsAg) |
Study summary document link (including results): |
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Document reference: 41089 |
Study title: A randomized double-blind study evaluating the safety, tolerability and efficacy of SMOF 20% compared to Intralipid in premature infants |
Active substance: REFINED SOYBEAN OIL; MEDIUM CHAINED TRIGLYCERIDES; REFINED OLIVE OIL; FISH OIL |
Study summary document link (including results): |
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Document reference: 40152 |
Study title: Kwiatkowski JL, Manno CS: Blood transfusion support in pediatric cardiovascular surgey. Transfusion Science 1999; 21: 63-72 Kwiatkowski JL, Manno CS: Blood transfusion support in pediatric cardiovascular surgey. Transfusion Science 1999; 21: 63-72 |
Active substance: PROTAMINE |
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Document reference: 35087 |
Study title: Pouard P: Review of Efficacy Parameters. Ann Thorac Surg 1998; 65: S40-4 Pouard P: Review of Efficacy Parameters. Ann Thorac Surg 1998; 65: S40-4 |
Active substance: PROTAMINE |
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Document reference: 35085 |
Study title: An open label, multicenter, international pilot study evaluating the efficacy and safety of Pegylated interferon alfa-2a in combination with ribavirin in pediatric and teenage patients with CHC virus infection (CHIPS) [100 children adolescents aged 6 – 18 years with CHC (all genotypes)] |
Active substance: RIBAVIRIN |
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Document reference: 35302 |
Study title: Luna Solano JL, Silva Baeza JC.. Ed Medico [Mexico] April 1973;23(1):57- 58,61 Methisporinol in some common infectious viraliseasesLuna Solano JL, Silva Baeza JC.. Ed Medico [Mexico] April 1973;23(1):57- 58,61 Methisporinol in some common infectious viraliseases |
Active substance: INOSINE |
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Document reference: 30145 |
Study title: Moroni M, Lazzarin A, Galli M.. Presented at the 15th National Congress of the Italian Society of Clinical Allergology and Immunology. October 30-November 1, 1981; Rome, Italy; 73-84. Immunoterapia delle infezioni chroniche e recidivanti. Moroni M, Lazzarin A, Galli M.. Presented at the 15th National Congress of the Italian Society of Clinical Allergology and Immunology. October 30-November 1, 1981; Rome, Italy; 73-84. Immunoterapia delle infezioni chroniche e recidivanti. |
Active substance: INOSINE |
Study summary document link (including results): |
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Document reference: 30149 |
Study title: Cytogenetic analysis of peripheral blood lymphocytes after arteriography (exposure to x-rays and contrast medium)Popova L 2005. Radio/ Oncol 2005; 39(2): 153-8. |
Active substance: IODIXANOL |
Study summary document link (including results): 2011-09 GE Visipaque response List of published articles.doc |
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Document reference: 48197 |
Study title: Bedavanija A, Singalavanija A, Kombara M.: Solcoseryl Eye Gel: An Effective Adjunct in the Treatment of Chronic Ulcers of the Cornea. J.med. Assoc. Thailand 68, 415-418 (1985). Bedavanija A, Singalavanija A, Kombara M.: Solcoseryl Eye Gel: An Effective Adjunct in the Treatment of Chronic Ulcers of the Cornea. J.med. Assoc. Thailand 68, 415-418 (1985). |
Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
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Document reference: 35104 |
Study title: Egorova G.B., Avetisov S.E., Churkina M.N., Rybakova E.: A comparative assessment of contact lens tolerance and a study of possibilities for its improvement. Egorova G.B., Avetisov S.E., Churkina M.N., Rybakova E.: A comparative assessment of contact lens tolerance and a study of possibilities for its improvement. |
Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
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Document reference: 35099 |
Study title: Gerkowicz K.; Toczolowski J.; Hamerski W.; Jedrzejewski D.; Gerkowicz M.: Evaluation of the effectiveness of Solcoseryl Eye-Gel in the treatment of some corneal diseases. Klin. Oczna 87: 21-22, 1985. Gerkowicz K.; Toczolowski J.; Hamerski W.; Jedrzejewski D.; Gerkowicz M.: Evaluation of the effectiveness of Solcoseryl Eye-Gel in the treatment of some corneal diseases. Klin. Oczna 87: 21-22, 1985. |
Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
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Document reference: 35106 |
Study title: Mauch-P-M, Weinstein-H, Botnick-L, Belli-J, Cassady-J-R. An evaluation of long-term survival and treatment complications in children with Hodgkin's disease. Cancer, {Cancer}, 1 Mar 1983, vol. 51, no. 5, p. 925-32, ISSN: 0008-543X.Mauch-P-M, Weinstein-H, Botnick-L, Belli-J, Cassady-J-R. An evaluation of long-term survival and treatment complications in children with Hodgkin's disease. Cancer, {Cancer}, 1 Mar 1983, vol. 51, no. 5, p. 925-32, ISSN: 0008-543X. |
Active substance: PROCARBAZINE |
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Document reference: 34783 |
Study title: Fernandez-Bouzas-A, Ramirez-Jimenez-H, Vazquez-Zamudio-J, Alonso- Vanegas-M, Mendizabal-Guerra-R. Department of Neuroradiology, Hospital 20 de Noviembre, ISSSTE, Mexico City. Brain calcifications and dementia in children treated with radiotherapy and intrathecal methotrexate. Journal of neurosurgical sciences, {J-Neurosurg-Sci}, Oct-Dec 1992, vol. 36, no. 4, p. 211-4, ISSN: 0390-5616.Fernandez-Bouzas-A, Ramirez-Jimenez-H, Vazquez-Zamudio-J, Alonso- Vanegas-M, Mendizabal-Guerra-R. Department of Neuroradiology, Hospital 20 de Noviembre, ISSSTE, Mexico City. Brain calcifications and dementia in children treated with radiotherapy and intrathecal methotrexate. Journal of neurosurgical sciences, {J-Neurosurg-Sci}, Oct-Dec 1992, vol. 36, no. 4, p... |
Active substance: PROCARBAZINE |
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Document reference: 34711 |
Study title: Eur Radiol. 1998;8(6):1054-7. Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study. Skalpe IO, Bonneville JF, Grane P, Gyldenstedt C, Otto B, Kristoffersen DT, Svaland MG. Eur Radiol. 1998;8(6):1054-7. Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study. Skalpe IO, Bonneville JF, Grane P, Gyldenstedt C, Otto B, Kristoffersen DT, Svaland MG. |
Active substance: IODIXANOL |
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Document reference: 30352 |
Study title: Evaluation of a coronary-cameral fistula: benefits of coronary dual-source MDCT angiography in childrenLerner CB 2008. Pediatr Radiol (2008) 38:874–878 |
Active substance: IODIXANOL |
Study summary document link (including results): 2011-09 GE Visipaque response List of published articles.doc |
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Document reference: 48201 |
Study title: Frequency, Management, and Outcome of Extravasation of Nonionic Iodinated Contrast Medium in 69 657 Intravenous InjectionsWang CL 2007. Radiology: Volume 243: Number 1-April 2007 |
Active substance: IODIXANOL |
Study summary document link (including results): 2011-09 GE Visipaque response List of published articles.doc |
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Document reference: 48198 |
Study title: Lange-B, Littman-P. Div. Oncol., Hosp. Univ. Pennsylvania, Philadelphia, PA 19104, United States. Management of Hodgkin's disease in children and adolescents. Cancer {CANCER}, 1983, Vol/Iss/Pg. 51/8 (1371-1377).Lange-B, Littman-P. Div. Oncol., Hosp. Univ. Pennsylvania, Philadelphia, PA 19104, United States. Management of Hodgkin's disease in children and adolescents. Cancer {CANCER}, 1983, Vol/Iss/Pg. 51/8 (1371-1377). |
Active substance: PROCARBAZINE |
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Document reference: 34768 |
Study title: Meadows-A-T, Silber-J. Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, United States. Delayed consequences of therapy for childhood cancer. Ca-A Cancer Journal for Clinicians {CA-CANCER-J-CLIN}, 1985, Vol/Iss /Pg. 35/5 (271-286).Meadows-A-T, Silber-J. Department of Pediatrics, University of Pennsylvania School of Medicine, Philadelphia, PA, United States. Delayed consequences of therapy for childhood cancer. Ca-A Cancer Journal for Clinicians {CA-CANCER-J-CLIN}, 1985, Vol/Iss /Pg. 35/5 (271-286). |
Active substance: PROCARBAZINE |
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Document reference: 34786 |
Study title: Morgenfeld-M-C, Pavlovsky-A, Suarez-A, Somoza-N, Pavlovsky-S, Palau- M, Barros-C-A. Combined cyclophosphamide vincristine, procarbazine, and prednisone (COPP) therapy of malignant lymphoma. Evaluation of 190 patients. Cancer, {Cancer}, Oct 1975, vol. 36, no. 4, p. 1241-9, ISSN: 0008-543X.Morgenfeld-M-C, Pavlovsky-A, Suarez-A, Somoza-N, Pavlovsky-S, Palau- M, Barros-C-A. Combined cyclophosphamide vincristine, procarbazine, and prednisone (COPP) therapy of malignant lymphoma. Evaluation of 190 patients. Cancer, {Cancer}, Oct 1975, vol. 36, no. 4, p. 1241-9, ISSN: 0008-543X. |
Active substance: PROCARBAZINE |
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Document reference: 34787 |
Study title: Fryer-C-J, Hutchinson-R-J, Krailo-M, Collins-R-D, Constine-L-S, Hays- D-M, Heller-R-M, Davis-P-C, Nachman-J, O-Brien-R-T, O-Neill-J-A, Pringle-K-C, Trigg-M-E, Hammond-G-D. Childrens Cancer Study Group, Operations Office, 199 North Lake Ave, Pasadena, CA 91101, United States. Efficacy and toxicity of 12 courses of ABVD chemotherapy followed by low-dose regional radiation in advanced Hodgkin's disease in children: A report from the Childrens Cancer Study Group. Journal of Clinical Oncology {J-CLIN-ONCOL}, 1990, Vol/Iss/Pg. 8/12 (1971-1980), ISSN: 0732-183X.Fryer-C-J, Hutchinson-R-J, Krailo-M, Collins-R-D, Constine-L-S, Hays- D-M, Heller-R-M, Davis-P-C, Nachman-J, O-Brien-R-T, O-Neill-J-A, Pringle-K-C, Trigg-M-E, Hammond-G-D. Childrens Cancer Study Group, Operations... |
Active substance: PROCARBAZINE |
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Document reference: 34714 |
Study title: Petera-J, Macharova-H, Pohankova-R, Malir-A, Coupek-P, Konecný-M, Patera-J, Pecina-J, Drbal-J, Koukalova-H, Vasova-I. Masaryk Memorial Cancer Institute, Brno, Czech Republic. Petera @fuhk.cz. Radiotherapy of early stages Hodgkin's disease. 10 years experience of the Masaryk Memorial Cancer Institute. Neoplasma, {Neoplasma}, 2000, vol. 47, no. 2, p. 129-32, ISSN: 0028-2685.Petera-J, Macharova-H, Pohankova-R, Malir-A, Coupek-P, Konecný-M, Patera-J, Pecina-J, Drbal-J, Koukalova-H, Vasova-I. Masaryk Memorial Cancer Institute, Brno, Czech Republic. Petera @fuhk.cz. Radiotherapy of early stages Hodgkin's disease. 10 years experience of the Masaryk Memorial Cancer Institute. Neoplasma, {Neoplasma}, 2000, vol. 47, no. 2, p. 129-32, ISSN: 0028-2685. |
Active substance: PROCARBAZINE |
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Document reference: 34806 |
Study title: Longo-D-L, Russo-A, Duffey-P-L, Hubbard-S-M, Glatstein-E, Hill-J-B, Division of Cancer Treatment, National Cancer Institute, Bethesda, MD. Treatment of advanced-stage massive mediastinal Hodgkin's disease: the case for combined modality treatment. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Feb 1991, vol. 9, no. 2, p. 227-35, ISSN: 0732-183X.Longo-D-L, Russo-A, Duffey-P-L, Hubbard-S-M, Glatstein-E, Hill-J-B, Division of Cancer Treatment, National Cancer Institute, Bethesda, MD. Treatment of advanced-stage massive mediastinal Hodgkin's disease: the case for combined modality treatment. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol... |
Active substance: PROCARBAZINE |
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Document reference: 34775 |
Study title: Hamilton-V-M, Norris-C, Bunin-N, Goldwein-J-W, Bunin-G-R, Lange-B, Meadows-A-T. Division of Oncology, Children's Hospital of Philadelphia, Pennsylvania 19104, USA. Cyclophosphamide-based, seven-drug hybrid and low-dose involved field radiation for the treatment of childhood and adolescent Hodgkin disease. Journal of pediatric hematology/oncology : official journal of the American Society of Pediatric Hematology/Oncology, {J-Pediatr- Hematol-Oncol}, Feb 2001, vol. 23, no. 2, p. 84-8, ISSN: 1077-4114.Hamilton-V-M, Norris-C, Bunin-N, Goldwein-J-W, Bunin-G-R, Lange-B, Meadows-A-T. Division of Oncology, Children's Hospital of Philadelphia, Pennsylvania 19104, USA. Cyclophosphamide-based, seven-drug hybrid and low-dose involved field radiation for ... |
Active substance: PROCARBAZINE |
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Document reference: 34732 |
Study title: Hartmann-O, Oberlin-O, Beaujean-F, Brugieres-L, Valteau-D, Vassal-G, Lemerle-J. Departement de Pediatrie, Institut Gustave-Roussy, 94805 Villejuif Cedex, France. High-dose chemotherapy followed by autologous bone marrow transplantation in children's metastatic Ewing sarcoma. Bulletin du Cancer {BULL-CANCER}, 1990, Vol/Iss/Pg. 77/2 (181-187), ISSN: 0007-4551.Hartmann-O, Oberlin-O, Beaujean-F, Brugieres-L, Valteau-D, Vassal-G, Lemerle-J. Departement de Pediatrie, Institut Gustave-Roussy, 94805 Villejuif Cedex, France. High-dose chemotherapy followed by autologous bone marrow transplantation in children's metastatic Ewing sarcoma. Bulletin du Cancer {BULL-CANCER}, 1990, Vol/Iss/Pg. 77/2 (181-187), ISSN: 0007-4551. |
Active substance: PROCARBAZINE |
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Document reference: 34733 |
Study title: Heath-John-A, Turner-Christopher-D, Poussaint-Tina-Young, Scott-R- Michael, Goumnerova-Liliana, Kieran-Mark-W. Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. john.heath@rch.org.au. Chemotherapy for progressive low-grade gliomas in children older than ten years: the Dana-Farber experience. Pediatric hematology and oncology, {Pediatr-Hematol-Oncol}, Oct-Nov 2003, vol. 20, no. 7, p. 497-504, ISSN: 0888-0018.Heath-John-A, Turner-Christopher-D, Poussaint-Tina-Young, Scott-R- Michael, Goumnerova-Liliana, Kieran-Mark-W. Department of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA. john.heath@rch.org.au. Chemotherapy for progressive low-grade gliomas in children older than ten years: the Dana-Farber... |
Active substance: PROCARBAZINE |
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Document reference: 34737 |
Study title: Yaniv-I, Saab-A, Cohen-I-J, Goshen-Y, Loven-D, Stark-B, Tamary-H, Zaizov-R. Department of Pediatric Hematology Oncology, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. Hodgkin disease in children: reduced tailored chemotherapy for stage I-II disease. Journal of pediatric hematology/oncology : official journal of the American Society of Pediatric Hematology/Oncology, {J-Pediatr- Hematol-Oncol}, Feb 1996, vol. 18, no. 1, p. 76-80, ISSN: 1077-4114.Yaniv-I, Saab-A, Cohen-I-J, Goshen-Y, Loven-D, Stark-B, Tamary-H, Zaizov-R. Department of Pediatric Hematology Oncology, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. Hodgkin disease in children: reduced tailored chemotherapy for stage I-II disease. Journal of pediatric hem... |
Active substance: PROCARBAZINE |
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Document reference: 34880 |
Study title: Marques De Carvalho |
Active substance: PROMETHAZINE AND MAGNESIUM BROMHYDRATE GLUTAMATE |
Study summary document link (including results): MarquesDeCarvalho_Bol.daClin.Psiq.,II,1,p.6-22,1963_ORIG.pdf |
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Document reference: 48130 |
Study title: Urgesi-A, Vasario-E, Monetti-U, et-al. Universita di Torino, Istituto di Radiologia, Divisione di Radioterapia, 10126 Torino, Italy. Treatment of childhood brain stem tumors with irradiation and chemotherapy. Preliminary results. Minerva Pediatrica {MINERVA-PEDIATR}, 1985, Vol/Iss/Pg. 37/20 (779-785).Urgesi-A, Vasario-E, Monetti-U, et-al. Universita di Torino, Istituto di Radiologia, Divisione di Radioterapia, 10126 Torino, Italy. Treatment of childhood brain stem tumors with irradiation and chemotherapy. Preliminary results. Minerva Pediatrica {MINERVA-PEDIATR}, 1985, Vol/Iss/Pg. 37/20 (779-785). |
Active substance: PROCARBAZINE |
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Document reference: 34862 |
Study title: Vailati-G, Occhiogrosso-M, Belsanti-M, et-al. Catt. Neurochir., Univ. Bari, Bari, Italy. Medulloblastomas and other intracranial brain tumors in infacy and childhood: Late effects of chemio and radiotherapy. Folia Oncologica {FOLIA-ONCOL}, 1982, Vol/Iss/Pg. 5/3 (523-529).Vailati-G, Occhiogrosso-M, Belsanti-M, et-al. Catt. Neurochir., Univ. Bari, Bari, Italy. Medulloblastomas and other intracranial brain tumors in infacy and childhood: Late effects of chemio and radiotherapy. Folia Oncologica {FOLIA-ONCOL}, 1982, Vol/Iss/Pg. 5/3 (523-529). |
Active substance: PROCARBAZINE |
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Document reference: 34863 |
Study title: van-den-Berg-H, Furstner-F, van-den-Bos-C, Behrendt-H. Department of Pediatric Oncology, Emma Children Hospital AMC, University of Amsterdam, Amsterdam; The Netherlands. h.vandenberg@amc.uva.nl. Decreasing the number of MOPP courses reduces gonadal damage in survivors of childhood Hodgkin disease. Pediatric blood & cancer, {Pediatr-Blood-Cancer}, Mar 2004, vol. 42, no. 3, p. 210-5, ISSN: 1545-5009.van-den-Berg-H, Furstner-F, van-den-Bos-C, Behrendt-H. Department of Pediatric Oncology, Emma Children Hospital AMC, University of Amsterdam, Amsterdam; The Netherlands. h.vandenberg@amc.uva.nl. Decreasing the number of MOPP courses reduces gonadal damage in survivors of childhood Hodgkin disease. Pediatric blood & cancer, {Pediatr-Blood-Cancer}, Mar 2004,... |
Active substance: PROCARBAZINE |
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Document reference: 34864 |
Study title: van-den-Berg-H, Zsiros-J, Behrendt-H. Emma Kinderziekenhuis AMC, University of Amsterdam, The Netherlands. Treatment of childhood Hodgkin's disease without radiotherapy. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Jun 1997, vol. 15, no. 6, p. 2247-53, ISSN: 0732-183X.van-den-Berg-H, Zsiros-J, Behrendt-H. Emma Kinderziekenhuis AMC, University of Amsterdam, The Netherlands. Treatment of childhood Hodgkin's disease without radiotherapy. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Jun 1997, vol. 15, no. 6, p. 2247-53, ISSN: 0732-183X. |
Active substance: PROCARBAZINE |
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Document reference: 34865 |
Study title: van-Eys-J, Cangir-A, Coody-D, Smith-B. MOPP regimen as primary chemotherapy for brain tumors in infants. Journal of neuro-oncology, {J-Neurooncol}, 1985, vol. 3, no. 3, p. 237-43, ISSN: 0167-594X.van-Eys-J, Cangir-A, Coody-D, Smith-B. MOPP regimen as primary chemotherapy for brain tumors in infants. Journal of neuro-oncology, {J-Neurooncol}, 1985, vol. 3, no. 3, p. 237-43, ISSN: 0167-594X. |
Active substance: PROCARBAZINE |
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Document reference: 34866 |
Study title: Perani V. Riv Patol Clin Sep/Oct 1978;33(5):1-15. . Clinical evaluation of the efficacy of a new antiviral drug, methisoprinol, in pediatric infectionsPerani V. Riv Patol Clin Sep/Oct 1978;33(5):1-15. . Clinical evaluation of the efficacy of a new antiviral drug, methisoprinol, in pediatric infections |
Active substance: INOSINE |
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Document reference: 30155 |
Study title: Perani V. Rivista di Patalogia e Clinica Sept-Oct 1978;33(5):361-372. Clinical evaluation of the efficacy of a new antiviral drug, methisoprinol, in pediatric infections.Perani V. Rivista di Patalogia e Clinica Sept-Oct 1978;33(5):361-372. Clinical evaluation of the efficacy of a new antiviral drug, methisoprinol, in pediatric infections. |
Active substance: INOSINE |
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Document reference: 30156 |
Study title: Schellong-G, Braemswig-J-H, Schwarze-E-W, Wannenmacher-M. Children's Hospital University of Muenster, FRG. An approach to reduce treatment and invasive staging in childhood Hodgkin's disease: the sequence of the German DAL multicenter studies. Bulletin du cancer, {Bull-Cancer}, 1988, vol. 75, no. 1, p. 41-51,Schellong-G, Braemswig-J-H, Schwarze-E-W, Wannenmacher-M. Children's Hospital University of Muenster, FRG. An approach to reduce treatment and invasive staging in childhood Hodgkin's disease: the sequence of the German DAL multicenter studies. Bulletin du cancer, {Bull-Cancer}, 1988, vol. 75, no. 1, p. 41-51, |
Active substance: PROCARBAZINE |
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Document reference: 34831 |
Study title: Schellong-G, Bramswig-J-H, Schwarze-E-W, Wannenmacher-M. Children's Hospital University of Munster, D-4400 Munster, Germany. An approach to reduce treatment and invasive staging in childhood Hodgkin's disease: The sequence of the German DAL multicenter studies. Bulletin du Cancer {BULL-CANCER}, 1988, Vol/Iss/Pg. 75/1 (41-51), ISSN: 0007-4551.Schellong-G, Bramswig-J-H, Schwarze-E-W, Wannenmacher-M. Children's Hospital University of Munster, D-4400 Munster, Germany. An approach to reduce treatment and invasive staging in childhood Hodgkin's disease: The sequence of the German DAL multicenter studies. Bulletin du Cancer {BULL-CANCER}, 1988, Vol/Iss/Pg. 75/1 (41-51), ISSN: 0007-4551. |
Active substance: PROCARBAZINE |
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Document reference: 34832 |
Study title: Guzzaloni G, Grugni G, Morabito F. Growth hormone response to hexarelin, growth hormone-releasing hormone plus pyridostigmine and arginine plus estrogen in prepubertal and early pubertal short children. Minerva Endocrinol. 1998 Dec;23(4):99-104Guzzaloni G, Grugni G, Morabito F. Growth hormone response to hexarelin, growth hormone-releasing hormone plus pyridostigmine and arginine plus estrogen in prepubertal and early pubertal short children. Minerva Endocrinol. 1998 Dec;23(4):99-104 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35192 |
Study title: Wirksamkeit und Vertraeglichkeit von Rytmonorm 10 mg, Dragees, bei Kindern - Ergebnisse einer multizentrischen Studie - (Efficacy and safety of Rytmonorm 10 mg sugar-coated tablets in children - Results of a multicentre study -) |
Active substance: PROPAFENONE |
Study summary document link (including results): propafenone-m03681.pdf |
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Document reference: 35059 |
Study title: A comparative evaluation of Diprivan (propofol) versus standard anesthetic techniques when administered for the induction and maintenance of general anesthesia in pediatric patients undergoing surgical procedures of one hour or greater duration |
Active substance: PROPOFOL |
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Document reference: 46124 |
Study title: 18. Cervova, Cs Pediat 1973; 28: 43 18. Cervova, Cs Pediat 1973; 28: 43 |
Active substance: PYRVINIUM |
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Document reference: 39547 |
Study title: 19. Chavarria, Lizano, Indian Pract 1967; 20: 25-29 19. Chavarria, Lizano, Indian Pract 1967; 20: 25-29 |
Active substance: PYRVINIUM |
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Document reference: 39548 |
Study title: 24. Fossati, Minerva Med 1964; 55: 3578-3580 24. Fossati, Minerva Med 1964; 55: 3578-3580 |
Active substance: PYRVINIUM |
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Document reference: 39553 |
Study title: Sobczyk W, Kulczycki J, Pilkowska E, Iwinska B, Milewska D, Szmigielski S. Neurol Neurochir Pol. 1991 Sep-Oct;25(5):626-33. Comparison of the results of the treatment of patients with SSPE using various immunomodulating preparationsSobczyk W, Kulczycki J, Pilkowska E, Iwinska B, Milewska D, Szmigielski S. Neurol Neurochir Pol. 1991 Sep-Oct;25(5):626-33. Comparison of the results of the treatment of patients with SSPE using various immunomodulating preparations |
Active substance: INOSINE |
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Document reference: 30167 |
Study title: Krystkowa M. Krystyna; Hydzikowa Marta: Application of Solcoseryl eye-gel in the treatment of certain corneal and conjunctival disease. Transl. from Klin. Ozna (Warszawa) 86, 457-495 (1985) Krystkowa M. Krystyna; Hydzikowa Marta: Application of Solcoseryl eye-gel in the treatment of certain corneal and conjunctival disease. Transl. from Klin. Ozna (Warszawa) 86, 457-495 (1985) |
Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
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Document reference: 35101 |
Study title: Nakova N, Belazelkaska Z, Bogdanovski I, Glavas E: SDAP for the treatment of chronic recurrent aphthous stomatitis and decubital ulcers in the buccal cavity. Accepted for publication by serbian Dental Journal 1, 1991 Nakova N, Belazelkaska Z, Bogdanovski I, Glavas E: SDAP for the treatment of chronic recurrent aphthous stomatitis and decubital ulcers in the buccal cavity. Accepted for publication by serbian Dental Journal 1, 1991 |
Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
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Document reference: 35098 |
Study title: Valoracion de la Rifamicina SV en la practica pediatrica - O. Turro et al - 1965 (Sem. Med., 127. 239 - 241.) Valoracion de la Rifamicina SV en la practica pediatrica - O. Turro et al - 1965 (Sem. Med., 127. 239 - 241.) |
Active substance: RIFAMYCIN |
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Document reference: 35385 |
Study title: Garaventa-A, Haupt-R, Panarello-C, Dodero-P, Gambini-C, Gambaro-M. Department of Pediatric Haematology/Oncology, G. Gaslini Children's Hospital, Genova, Italy. Early occurrence of a secondary thyroid carcinoma in a child treated for Hodgkin disease. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Mar 2001, vol. 36, no. 3, p. 396-7, ISSN: 0098-1532.Garaventa-A, Haupt-R, Panarello-C, Dodero-P, Gambini-C, Gambaro-M. Department of Pediatric Haematology/Oncology, G. Gaslini Children's Hospital, Genova, Italy. Early occurrence of a secondary thyroid carcinoma in a child treated for Hodgkin disease. Medical and pediatric oncology, {Med-Pediatr-Oncol}, Mar 2001, vol. 36, no. 3, p. 396-7, ISSN: 0098-1532. |
Active substance: PROCARBAZINE |
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Document reference: 34715 |
Study title: Geyer-J-R, Finlay-J-L, Boyett-J-M, Wisoff-J, Yates-A, Mao-L, Packer-R-J. Publications Office, Childrens Cancer Group, P.O. Box 60012, Arcadia, CA 91066-6012, United States. Survival of infants with malignant astrocytomas: A report from the Childrens Cancer Group. Cancer {CANCER}, 1995, Vol/Iss/Pg. 75/4 (1045-1050), ISSN: 0008-543X.Geyer-J-R, Finlay-J-L, Boyett-J-M, Wisoff-J, Yates-A, Mao-L, Packer-R-J. Publications Office, Childrens Cancer Group, P.O. Box 60012, Arcadia, CA 91066-6012, United States. Survival of infants with malignant astrocytomas: A report from the Childrens Cancer Group. Cancer {CANCER}, 1995, Vol/Iss/Pg. 75/4 (1045-1050), ISSN: 0008-543X. |
Active substance: PROCARBAZINE |
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Document reference: 34718 |
Study title: Three Dimensional CT Angiography for Patients with Congenital Heart Disease: Scanning Protocol for Pediatric PatientsJelnin V 2006. Catheterization and Cardiovascular Interventions 67:120-126 (2006) |
Active substance: IODIXANOL |
Study summary document link (including results): 2011-09 GE Visipaque response List of published articles.doc |
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Document reference: 48200 |
Study title: Neurology. 2001 Jan 23;56(2):266-7. SPECT imaging of the dopamine transporter in juvenile-onset dystonia. O'Sullivan JD, Costa DC, Gacinovic S, Lees AJ.Neurology. 2001 Jan 23;56(2):266-7. SPECT imaging of the dopamine transporter in juvenile-onset dystonia. O'Sullivan JD, Costa DC, Gacinovic S, Lees AJ. |
Active substance: ioflupane (123l) |
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Document reference: 41501 |
Study title: Neurology. 2004 Dec 14;63(11):2097-103. Imaging of dopaminergic dysfunction with [123I]FP-CIT SPECT in early-onset parkin disease. Varrone A, Pellecchia MT, Amboni M, Sansone V, Salvatore E, Ghezzi D, Garavaglia B, Brice A, Brunetti A, Bonavita V, De Michele G, Salvatore M, Pappatà S, Barone P. Neurology. 2004 Dec 14;63(11):2097-103. Imaging of dopaminergic dysfunction with [123I]FP-CIT SPECT in early-onset parkin disease. Varrone A, Pellecchia MT, Amboni M, Sansone V, Salvatore E, Ghezzi D, Garavaglia B, Brice A, Brunetti A, Bonavita V, De Michele G, Salvatore M, Pappatà S, Barone P. |
Active substance: ioflupane (123l) |
Study summary document link (including results): |
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Document reference: 41499 |
Study title: EMLA: an aid to suture removal following cleft lip repair. |
Active substance: LIDOCAINE |
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Document reference: 31218 |
Study title: Roettinger-E-M. (Survival of children with primitive neuroectodermal tumors and malignant ependymomas of the central nervous system after treatment with 8 cytostatic agents in one day. A report of the Children's Cancer Group). Strahlentherapie und Onkologie : Organ der Deutschen oentgengesellschaft ... (et al), {Strahlenther-Onkol}, May 1995, vol. 171, no. 5, p. 303-4, ISSN: 0179-7158.Roettinger-E-M. (Survival of children with primitive neuroectodermal tumors and malignant ependymomas of the central nervous system after treatment with 8 cytostatic agents in one day. A report of the Children's Cancer Group). Strahlentherapie und Onkologie : Organ der Deutschen oentgengesellschaft ... (et al), {Strahlenther-Onkol}, May ... |
Active substance: PROCARBAZINE |
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Document reference: 34815 |
Study title: van-Eys-J, Cangir-A, Pack-R, Baram-T. Department of Pediatrics, University of Texas System Cancer Center, M. D. Anderson Hospital and Tumor Institute, Houston 77030.. Phase I trial of procarbazine as a 5-day continuous infusion in children with central nervous system tumors. Cancer treatment reports, {Cancer-Treat-Rep}, Oct 1987, vol. 71, no. 10, p. 973-4, ISSN: 0361-5960. van-Eys-J, Cangir-A, Pack-R, Baram-T. Department of Pediatrics, University of Texas System Cancer Center, M. D. Anderson Hospital and Tumor Institute, Houston 77030.. Phase I trial of procarbazine as a 5-day continuous infusion in children with central nervous system tumors. Cancer treatment reports, {Cancer-Treat-Rep}, Oct 1987, vol. 71, no. 10, p. 973-4, ISSN: 0361-5960. |
Active substance: PROCARBAZINE |
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Document reference: 34867 |
Study title: Andersen M et al. Evaluation of growth hormone assays using ratio plots. Clin Chem. 1998 May;44(5):1032-8 Andersen M et al. Evaluation of growth hormone assays using ratio plots. Clin Chem. 1998 May;44(5):1032-8 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35193 |
Study title: Arvat E et al. The enhancing effect of pyridostigmine on the GH response to GHRH undergoes an accelerated age-related reduction in Down syndrome. Dementia. 1996 Sep-Oct;7(5):288-92Arvat E et al. The enhancing effect of pyridostigmine on the GH response to GHRH undergoes an accelerated age-related reduction in Down syndrome. Dementia. 1996 Sep-Oct;7(5):288-92 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35194 |
Study title: Zolezzi-P, Rubio-J, Cardemil-B, Born-R, Moraleda-L, Ramos-M-I, Albornoz-C, Amigo-O, Kyling-A, Badilla-V, et al. Instituto de Hematologia, Facultad de Medicina, Universidad Austral de Chile. (Hodgkin's disease in children. Modified COPP combined treatment and radiotherapy in advanced stages). Revista chilena de pediatria {Rev-Chil-Pediatr} 1990 Mar-Apr, VOL: 61 (2), P: 74-6, ISSN: 0370-4106.Zolezzi-P, Rubio-J, Cardemil-B, Born-R, Moraleda-L, Ramos-M-I, Albornoz-C, Amigo-O, Kyling-A, Badilla-V, et al. Instituto de Hematologia, Facultad de Medicina, Universidad Austral de Chile. (Hodgkin's disease in children. Modified COPP combined treatment and radiotherapy in advanced stages). Revista chilena de pediatria {Rev-Chil-Pediatr} 1990 Mar-Apr, VOL: 61 (2), P: 74-6, ISSN: 0... |
Active substance: PROCARBAZINE |
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Document reference: 34883 |
Study title: "Publication mentioned in CES made available in 2007 for national renewals: Options for the prevention and management of acute chemotherapy-induced nausea and vomiting in children. L.L. Dupuis, P.C. Nathan, Paediatric drugs 2003; 5(9): 597-613." "Publication mentioned in CES made available in 2007 for national renewals: Options for the prevention and management of acute chemotherapy-induced nausea and vomiting in children. L.L. Dupuis, P.C. Nathan, Paediatric drugs 2003; 5(9): 597-613." |
Active substance: PROCHLOPERAZINE |
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Document reference: 34969 |
Study title: A comparative evaluation of Diprivan /Diprivan N20 versus thiopental/halothane/N20 versus Diprivan/Diprivan when administered for the induction and maintenance of general anesthesia in pedaitric patients undergoing general surgical procedures of one hour or greater duration |
Active substance: PROPOFOL |
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Document reference: 46125 |
Study title: A comparison of Diprivan (propofol) and thiopentone for induction of anaesthesia in children. |
Active substance: PROPOFOL |
Study summary document link (including results): 035868_0208 Study Synopsis.pdf |
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Document reference: 46131 |
Study title: A multicenter, comparative, randomized trial to determine the overall safety and efficacy of 1% Diprivan vs 2% Diprivan vs standard agents without disodium edetate for sedation of trauma, postsurgical, or critically ill paediatric subjects. |
Active substance: PROPOFOL |
Study summary document link (including results): 0859IL0068 Study Synopsis.pdf |
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Document reference: 46137 |
Study title: A preliminary evaluation of the characteristics of propofol (Diprivan) for induction of general anaesthesia for paediatric surgery. |
Active substance: PROPOFOL |
Study summary document link (including results): 035868_0141 Study Synopsis.pdf |
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Document reference: 46128 |
Study title: Cordido F, Casanueva FF, Dieguez C. Cholinergic receptor activation by pyridostigmine restores growth hormone (GH) responsiveness to GH-releasing hormone administration in obese subjects: evidence for hypothalamic somatostatinergic participation in the blunted GH release of obesity. J Clin Endocrinol Metab. 1989 Feb;68(2):290-39 Cordido F, Casanueva FF, Dieguez C. Cholinergic receptor activation by pyridostigmine restores growth hormone (GH) responsiveness to GH-releasing hormone administration in obese subjects: evidence for hypothalamic somatostatinergic participation in the blunted GH release of obesity. J Clin Endocrinol Metab. 1989 Feb;68(2):290-39 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35215 |
Study title: Corrias A et al. GH/IGF-I axis in Prader-Willi syndrome: Evaluation of IGF-I levels and of the somatotroph responsiveness to various provocative stimuli. J Endocrinol Invest. April 20, 2000, 84-9Corrias A et al. GH/IGF-I axis in Prader-Willi syndrome: Evaluation of IGF-I levels and of the somatotroph responsiveness to various provocative stimuli. J Endocrinol Invest. April 20, 2000, 84-9 |
Active substance: PYRIDOSTIGMINE |
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Document reference: 35181 |
Study title: Remifentanil/Propofol versus Sevofluran/N2O für allgemeinchirurgische und HNO-Eingriffe bei Kindern: Ein Vergleich der Hämodynamik, des Einschlaf- und Aufwachverhaltens sowie der anästhesierelevanten Zeiten |
Active substance: REMIFENTANIL |
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Document reference: 35287 |
Study title: A randomised controlled trial comparing low molecular weight heparin (reviparin sodium) to standard of practice unfractionated heparin plus a vitamin K antagonist for the treatment of venous thromboembolism in a pediatric patient population. |
Active substance: REVIPARIN |
Study summary document link (including results): Reviparin-CL052.pdf |
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Document reference: 45107 |
Study title: An open-label dose-finding trial of low molecular weight heparin LU 47311 (Clivarine®) for the prophylaxis of deep vein thrombosis/pulmonary embolism in children with short term placement of central venous catheters. |
Active substance: REVIPARIN |
Study summary document link (including results): Reviparin-CL057.pdf |
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Document reference: 35289 |
Study title: An open-label, dose-finding trial of low molecular weight heparin (Clivarine®) for the treatment of deep vein thrombosis/pulmonary embolism in a pediatric patient population. |
Active substance: REVIPARIN |
Study summary document link (including results): Reviparin-CL022.pdf |
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Document reference: 35291 |
Study title: An open-label, multicenter, randomized trial comparing low molecular weight heparin (reviparin) to standard of care for the prophylaxis of deep vein thrombosis/pulmonary embolism in children with short term placement of central venous catheters. |
Active substance: REVIPARIN |
Study summary document link (including results): Reviparin-CL055.pdf |
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Document reference: 35290 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Rheuma-Heel (tablets) [AWB-AT] |
Active substance: Rheuma-Heel/ Rhumeel |
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Document reference: 40154 |
Study title: Sobczyk W, Pilkowska E, Iwinska-Buksowicz B. Neurol Neurochir Pol. 1999 Jul-Aug;33(4):797-805. The evaluation of the use of antineoplaston AS2-1 treatment in subacute sclerosing panencephalitisSobczyk W, Pilkowska E, Iwinska-Buksowicz B. Neurol Neurochir Pol. 1999 Jul-Aug;33(4):797-805. The evaluation of the use of antineoplaston AS2-1 treatment in subacute sclerosing panencephalitis |
Active substance: INOSINE |
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Document reference: 30169 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Rhododendroneel S (drops) [AWB-AT] |
Active substance: Rhododendroneel/ Rhododendroneel S |
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Document reference: 40153 |
Study title: Seiler-R-W, Bernasconi-S, Berchtold-W, Feldges-A, Imbach-P, Luethi-A, Pluess-H-J, Vassella-F, Wyss-M, Wagner-H-P. Adjuvant chemotherapy with procarbazine, vincristine and prednisone for medulloblastomas. A preliminary report. Helvetica paediatrica acta, {Helv-Paediatr-Acta}, Jul 1981, vol. 36, no. 3, p. 249-54, ISSN: 0018-022X.Seiler-R-W, Bernasconi-S, Berchtold-W, Feldges-A, Imbach-P, Luethi-A, Pluess-H-J, Vassella-F, Wyss-M, Wagner-H-P. Adjuvant chemotherapy with procarbazine, vincristine and prednisone for medulloblastomas. A preliminary report. Helvetica paediatrica acta, {Helv-Paediatr-Acta}, Jul 1981, vol. 36, no. 3, p. 249-54, ISSN: 0018-022X. |
Active substance: PROCARBAZINE |
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Document reference: 34840 |
Study title: Spicak V, Polackova M, Tlaskalova H, Kacirek E. Presented at the 8th European Immunology Meeting; August 30 - September 5, 1987; Zagreb, Yugoslavia. (Abstract only). Modimunal®/Isoprinosine® in the treatment of asthmatic children.Spicak V, Polackova M, Tlaskalova H, Kacirek E. Presented at the 8th European Immunology Meeting; August 30 - September 5, 1987; Zagreb, Yugoslavia. (Abstract only). Modimunal®/Isoprinosine® in the treatment of asthmatic children. |
Active substance: INOSINE |
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Document reference: 30170 |
Study title: Spicak V, Polackova M, Tlaskalova H, Kaminkova J, Vanecek K. Presented at the 4th International Conference on Immunopharmacology; Kyoto, Japan; 1988. (Abstract only). Immunomodulation by Isoprinosine® in the treatment of asthmatic childrenSpicak V, Polackova M, Tlaskalova H, Kaminkova J, Vanecek K. Presented at the 4th International Conference on Immunopharmacology; Kyoto, Japan; 1988. (Abstract only). Immunomodulation by Isoprinosine® in the treatment of asthmatic children |
Active substance: INOSINE |
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Document reference: 30171 |
Study title: Wiedermann D, Widermannova D, Lokaj J. Scripta Medica [Czech edition from Brno]. 1986; 59(7):415-424. Several parameters of cellular and humoral immune function in children with recurrent respiratory infections treated with Isoprinosine®.Wiedermann D, Widermannova D, Lokaj J. Scripta Medica [Czech edition from Brno]. 1986; 59(7):415-424. Several parameters of cellular and humoral immune function in children with recurrent respiratory infections treated with Isoprinosine®. |
Active substance: INOSINE |
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Document reference: 30177 |
Study title: Wiedermann D, Wiedermannova D, Lokaj J. International Journal of Immunopharmacology 1987; 9(8):947-949. .Immunorestoration in children with recurrent respiratory infections treated with Isoprinosine®.Wiedermann D, Wiedermannova D, Lokaj J. International Journal of Immunopharmacology 1987; 9(8):947-949. .Immunorestoration in children with recurrent respiratory infections treated with Isoprinosine®. |
Active substance: INOSINE |
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Document reference: 30178 |
Study title: Vamos I, Kövesi G: Experince in use of Solcoseryl Dental adhesive Paste. Különenyomat 1980, 73, 361-363 Vamos I, Kövesi G: Experince in use of Solcoseryl Dental adhesive Paste. Különenyomat 1980, 73, 361-363 |
Active substance: PROTEIN FREE DIALYSATE OF CALF BLOOD |
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Document reference: 35089 |
Study title: A study to determine the safety of virus inactivated factor concentrates in Hameophiliacs Naive to Blood Product Admiinistration (International Factor Safety Study) A study to determine the safety of virus inactivated factor concentrates in Hameophiliacs Naive to Blood Product Admiinistration (International Factor Safety Study) |
Active substance: PROTHROMBIN |
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Document reference: 35112 |
Study title: "Factor X survival and therapeutic factor X levels in the abnormal factor X (factor X FRIULI) COAGULATION DISORDER. Acta Haematol (1974) 52: 223-231.(Girolami A et al.) " "Factor X survival and therapeutic factor X levels in the abnormal factor X (factor X FRIULI) COAGULATION DISORDER. Acta Haematol (1974) 52: 223-231.(Girolami A et al.) " |
Active substance: PROTHROMBIN |
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Document reference: 35110 |
Study title: "Laboratory and clinical evaluation of concentrates for treatment of haemophilia. Acta Clin Belg (1975) 30: 437-448. (Verstraete M, Vermylen J. ) " "Laboratory and clinical evaluation of concentrates for treatment of haemophilia. Acta Clin Belg (1975) 30: 437-448. (Verstraete M, Vermylen J. ) " |
Active substance: PROTHROMBIN |
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Document reference: 35108 |
Study title: Geyer-J-R, Zeltzer-P-M, Boyett-J-M, Rorke-L-B, Stanley-P, Albright-A- L, Wisoff-J-H, Milstein-J-M, Allen-J-C, Finlay-J-L, et al. Children's Hospital and Medical Center, Seattle, WA. Survival of infants with primitive neuroectodermal tumors or malignant ependymomas of the CNS treated with eight drugs in 1 day: a report from the Childrens Cancer Group. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Aug 1994, vol. 12, no. 8, p. 1607-15, ISSN: 0732-183X.Geyer-J-R, Zeltzer-P-M, Boyett-J-M, Rorke-L-B, Stanley-P, Albright-A- L, Wisoff-J-H, Milstein-J-M, Allen-J-C, Finlay-J-L, et al. Children's Hospital and Medical Center, Seattle, WA. Survival of infants with primitive neuroectodermal tumors or malignan... |
Active substance: PROCARBAZINE |
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Document reference: 34720 |
Study title: Geyer-R, Levy-M, Berger-M-S, Milstein-J, Griffin-B, Bleyer-W-A. Depts. Ped./Neuro Surg./Radia., Children's Hos./Medical Care, University of Washington, Seattle, WA, United States. Infants with medulloblastoma: a single institution review of survival. Neurosurgery {NEUROSURGERY}, 1991, Vol/Iss/Pg. 29/5 (707-711), ISSN: 0148-396X.Geyer-R, Levy-M, Berger-M-S, Milstein-J, Griffin-B, Bleyer-W-A. Depts. Ped./Neuro Surg./Radia., Children's Hos./Medical Care, University of Washington, Seattle, WA, United States. Infants with medulloblastoma: a single institution review of survival. Neurosurgery {NEUROSURGERY}, 1991, Vol/Iss/Pg. 29/5 (707-711), ISSN: 0148-396X. |
Active substance: PROCARBAZINE |
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Document reference: 34721 |
Study title: Double-blind comparative study of Ultravist, Solutrast and Omnipaque in excretory urography in childrenJ Invasive Cardiol. 2003 Mar;15(3):133-8. Early and late reactions following the use of iopamidol 340, iomeprol 350 and iodixanol 320 in cardiac catheterization. Sutton AG, Finn P, Campbell PG, Price DJ, Hall JA, Stewart MJ, Davies A, Linker NJ, De Belder MA. |
Active substance: IOHEXOL |
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Document reference: 30379 |
Study title: Eur Radiol. 1998;8(6):1054-7. Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study. Skalpe IO, Bonneville JF, Grane P, Gyldenstedt C, Otto B, Kristoffersen DT, Svaland MG. Eur Radiol. 1998;8(6):1054-7. Myelography with a dimeric (iodixanol) and a monomeric (iohexol) contrast medium: a clinical multicentre comparative study. Skalpe IO, Bonneville JF, Grane P, Gyldenstedt C, Otto B, Kristoffersen DT, Svaland MG. |
Active substance: IOHEXOL |
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Document reference: 30372 |
Study title: Olive-D, Philip-T, Zucker-J-M, et-al. Service de Medicine Infantile II, Hopital d'Enfants, 54511 Vandoeuvre Cedex 11, France. Efficacy of '8 drugs in 1 day' regimen in the treatment of poor risk childhood brain tumors. European Paediatric Haematology and Oncology {EUR-PAEDIATR-HAEMATOL-ONCOL}, 1985, Vol/Iss/Pg. 2/1 (57-58).Olive-D, Philip-T, Zucker-J-M, et-al. Service de Medicine Infantile II, Hopital d'Enfants, 54511 Vandoeuvre Cedex 11, France. Efficacy of '8 drugs in 1 day' regimen in the treatment of poor risk childhood brain tumors. European Paediatric Haematology and Oncology {EUR-PAEDIATR-HAEMATOL-ONCOL}, 1985, Vol/Iss/Pg. 2/1 (57-58). |
Active substance: PROCARBAZINE |
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Document reference: 34798 |
Study title: Olive-D. Serv. Ped. 'A', CHU, Nancy, France. Advances in the management of chemotherapy in solid tumors in children. Archives Francaises de Pediatrie {ARCH-FR-PEDIATR}, 1976, Vol/Iss/Pg. 33/6 (607-620).Olive-D. Serv. Ped. 'A', CHU, Nancy, France. Advances in the management of chemotherapy in solid tumors in children. Archives Francaises de Pediatrie {ARCH-FR-PEDIATR}, 1976, Vol/Iss/Pg. 33/6 (607-620). |
Active substance: PROCARBAZINE |
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Document reference: 34799 |
Study title: A Study to Compare the Efficacy and Safety of 0.25% Levobupivacaine to 0.25% Bupivacaine when Administered as a Caudal Extradural for PostOperative Analgesia in Paediatric In-Patients Undergoing Elective Orthopaedic or Major Urological Surgery |
Active substance: LEVOBUVICAINE HCL |
Study summary document link (including results): Levobupivacaine-30590.pdf |
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Document reference: 47650 |
Study title: Astudy to assess the efficacy and safety of 0.25% levobupivacaine when administered as a caudal injection in paediatric patients undergoing hernia repair, circumcision or orchidopexy. |
Active substance: LEVOBUVICAINE HCL |
Study summary document link (including results): Levobupivacaine-30585.pdf |
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Document reference: 47649 |
Study title: Double-Blind Randomized Controlled Trial of05% L.evobupivacaine for Post-Operative Pain Control in Pediatric Patients Foliowing Hernia Repair Surgery |
Active substance: LEVOBUVICAINE HCL |
Study summary document link (including results): Levobupivacaine-CS007.pdf |
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Document reference: 47648 |
Study title: A placebo-controlled trial of the therapeutic value of levocabastine eye drops used as required in the treatment of seasonal allergic conjunctivitis (13.1-56.7 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62493_Interventional_Levocabastine.xls |
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Document reference: 31105 |
Study title: Gobel-U, Kauther-K, Seibert-H, et-al. Univ. Kinderklin. B, Univ., D-4000 Dusseldorf, Germany. Evaluation of combination chemotherapy with high-dose methotrexate ollowed by citrovorum factor rescue (CFR) and COPP in children with recurrent brain tumours. Acta Neurochirurgica {ACTA-NEUROCHIR}, 1982, Vol/Iss/Pg. 62/1-2 (129-130).Gobel-U, Kauther-K, Seibert-H, et-al. Univ. Kinderklin. B, Univ., D-4000 Dusseldorf, Germany. Evaluation of combination chemotherapy with high-dose methotrexate ollowed by citrovorum factor rescue (CFR) and COPP in children with recurrent brain tumours. Acta Neurochirurgica {ACTA-NEUROCHIR}, 1982, Vol/Iss/Pg. 62/1-2 (129-130). |
Active substance: PROCARBAZINE |
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Document reference: 34723 |
Study title: Scott, M.R.Report of a double-blind trial of Pyralvex against placebo in the relief of pain associated with mouth ulcers. 1987 49 subjects (36 evaluable) 16 m, 20 f, 7-67 y (39.2)Scott, M.R.Report of a double-blind trial of Pyralvex against placebo in the relief of pain associated with mouth ulcers. 1987 49 subjects (36 evaluable) 16 m, 20 f, 7-67 y (39.2) |
Active substance: RHUBARB AND SALICYLIC ACID |
Study summary document link (including results): |
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Document reference: 35294 |
Study title: Placebo-controlled comparison of levamisole, pyrantel pamoate, thiabendazole, piperazine citrate, and varlaus dosages of mebendazole in the treatment of ascariasis and trichuriasis in children. 1975 |
Active substance: MEBENDAZOLE |
Study summary document link (including results): |
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Document reference: 31539 |
Study title: A randomized study of Ultiva versus Halothane in neonates and infants undergoing surgery for pyloric stenosis |
Active substance: REMIFENTANIL |
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Document reference: 35285 |
Study title: Th 1165a metered aerosol: pediatrics / therapeutic observations. |
Active substance: FENOTEROL |
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Document reference: 27033 |
Study title: A comparative study of two different doses of Smith Kline-RIT rec-DNA Hepatitis B vaccine (10 mcg and 20 mcg). |
Active substance: r-DNA hepatitis B surface antigen (HBsAg) |
Study summary document link (including results): |
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Document reference: 47756 |
Study title: Hutchinson-R-J, Fryer-C-J, Davis-P-C, Nachman-J, Krailo-M-D, O-Brien-R-T, Collins-R-D, Whalen-T, Reardon-D, Trigg-M-E, Gilchrist-G-S. C.S. Mott Children's Hospital, Ann Arbor, MI, USA. MOPP or radiation in addition to ABVD in the treatment of pathologically staged advanced Hodgkin's disease in children: results of the Children's Cancer Group Phase III Trial. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, {J-Clin-Oncol}, Mar 1998, vol. 16, no. 3, p. 897-906, ISSN: 0732-183X.Hutchinson-R-J, Fryer-C-J, Davis-P-C, Nachman-J, Krailo-M-D, O-Brien-R-T, Collins-R-D, Whalen-T, Reardon-D, Trigg-M-E, Gilchrist-G-S. C.S. Mott Children's Hospital, Ann Arbor, MI, USA. MOPP or radiation in addition to ABVD i... |
Active substance: PROCARBAZINE |
Study summary document link (including results): |
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Document reference: 34744 |
Study title: Advanced pediatric joint imaging |
Active substance: PROMETHAZINE |
Study summary document link (including results): Advanced pediatric joint imaging.pdf |
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Document reference: 35046 |
Study title: Clinical observations with promethazine hydrochloride (PHERNERGAN ELIXIR), in paediatric practice. - Sarma D.N. Dass C.S.- (Indian Med. J., 1978, 72 (9), 156-157.) - Publication in PHENERGAN Tableelt 25mg, Syrup 1%, Sol inj 2,5%. Syndthesis documentation. French validation dossier 17/06 |
Active substance: PROMETHAZINE |
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Document reference: 35011 |
Study title: Maity-A, Goldwein-J-W, Lange-B, D-Angio-G-J. Department of Radiation Oncology, Hospital of the University of Department of Radiation Oncology, Hospital of the University of Pennsylvania, Philadelphia 19104. Mediastinal masses in children with Hodgkin's disease. An analysis of the Children's Hospital of Philadelphia and the Hospital of the University of Pennsylvania experience. University of Pennsylvania experience. Cancer, {Cancer}, 1 Jun 1992, vol. 69, no. 11, p. 2755-60, ISSN: 0008-543X.Maity-A, Goldwein-J-W, Lange-B, D-Angio-G-J. Department of Radiation Oncology, Hospital of the University of Department of Radiation Oncology, Hospital of the University of Pennsylvania, Philadelphia 19104. Mediastinal masses in children with Hodgkin's disease. An ... |
Active substance: PROCARBAZINE |
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Document reference: 34779 |
Study title: Makhonova-L-A, Polyakov-V-E, Susuleva-N-A, Ilyashenko-V-V. Detsk. Gematol. Otd., Vsesojuzn. Onkol. Nauch. Tsent., AMN SSSR, Moscow, Russia. Role of polychemotherapy in the program treatment of children with Hodgkin's disease. Pediatriya - Zhurnal im G.N. Speranskogo {PEDIATRIYA}, 1981, Vol/Iss /Pg. 60/8 (36-39).Makhonova-L-A, Polyakov-V-E, Susuleva-N-A, Ilyashenko-V-V. Detsk. Gematol. Otd., Vsesojuzn. Onkol. Nauch. Tsent., AMN SSSR, Moscow, Russia. Role of polychemotherapy in the program treatment of children with Hodgkin's disease. Pediatriya - Zhurnal im G.N. Speranskogo {PEDIATRIYA}, 1981, Vol/Iss /Pg. 60/8 (36-39). |
Active substance: PROCARBAZINE |
Study summary document link (including results): |
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Document reference: 34780 |
Study title: Van-Eys-J, Cangir-A. Dept. Ped., M.D. Anderson Hosp., Houston, Tex. 77030, United States. Chemotherapy for childhood brain tumors. Journal of Pediatrics {J-PEDIATR}, 1978, Vol/Iss/Pg. 93/3 (544-546).Van-Eys-J, Cangir-A. Dept. Ped., M.D. Anderson Hosp., Houston, Tex. 77030, United States. Chemotherapy for childhood brain tumors. Journal of Pediatrics {J-PEDIATR}, 1978, Vol/Iss/Pg. 93/3 (544-546). |
Active substance: PROCARBAZINE |
Study summary document link (including results): |
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Document reference: 34868 |
Study title: Van-Eys-J. Dept. Ped., Univ. Texas Syst. Cancer Cent., M.D. Anderson Hosp. Tum. Inst., Houston, Tex., United States. Chemotherapy for gliomas in children. Cancer Bulletin {CANCER-BULL}, 1975, Vol/Iss/Pg. 27/1 (16-19).Van-Eys-J. Dept. Ped., Univ. Texas Syst. Cancer Cent., M.D. Anderson Hosp. Tum. Inst., Houston, Tex., United States. Chemotherapy for gliomas in children. Cancer Bulletin {CANCER-BULL}, 1975, Vol/Iss/Pg. 27/1 (16-19). |
Active substance: PROCARBAZINE |
Study summary document link (including results): |
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Document reference: 34869 |
Study title: Van-Eys-J. Division of Pediatrics, The University of Texas M.D. AndersonHospital and Tumor Institute, Houston, TX, United States. The improved outlook for children with brain tumors. Cancer Bulletin {CANCER-BULL}, 1986, Vol/Iss/Pg. 38/1 (19-23).Van-Eys-J. Division of Pediatrics, The University of Texas M.D. AndersonHospital and Tumor Institute, Houston, TX, United States. The improved outlook for children with brain tumors. Cancer Bulletin {CANCER-BULL}, 1986, Vol/Iss/Pg. 38/1 (19-23). |
Active substance: PROCARBAZINE |
Study summary document link (including results): |
View full study record |
Document reference: 34870 |
Study title: Report in Clinical documentation for Marketing Authorisation Application (June 1987): Evaluation of therapeutic efficacy and tolerability of teicoplanin in serious infections caused by Gram-positive micro-organisms - Martino - 28 November 1985Report in Clinical documentation for Marketing Authorisation Application (June 1987): Evaluation of therapeutic efficacy and tolerability of teicoplanin in serious infections caused by Gram-positive micro-organisms - Martino - 28 November 1985 |
Active substance: TEICOPLANIN |
Study summary document link (including results): Teicoplanin STUDY Serious infections - Martino.xls |
View full study record |
Document reference: 44320 |
Study title: Perindopril preventive treatment on mortality in Duchenne muscular dystrophy: 10 years’ follow-upPerindopril preventive treatment on mortality in Duchenne muscular dystrophy: 10 years’ follow-up |
Active substance: PERINDOPRIL |
Study summary document link (including results): perindopril_CL3-09490-123-FRA_publication_Duboc_2007.pdf |
View full study record |
Document reference: 47712 |
Study title: Preventive effect of perindopril on the onset and progression of left ventricular dysfunction in subjects suffering from Duchenne Muscular Dystrophy. Double-blind multicentre, placebo-controlled study of 2 and 4 mg of perindopril in 60 subjects over a period of 3 years. |
Active substance: PERINDOPRIL |
Study summary document link (including results): perindopril_CL3-09490-123-FRA_publication_Duboc_2005.pdf |
View full study record |
Document reference: 45864 |
Study title: A randomized, multi-center, parallel-group, double-blind, vehicle-controlled study to evaluate the time of pruritus improvement during the first week of pimecrolimus cream 1% treatment in patients >2 years old with mild to moderate atopic dermatitis. |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CUS08 Art45 listing 2011.xls |
View full study record |
Document reference: 34104 |
Study title: CLINICAL EVALUATION IF SULPERAZON (SP) FOR INFECTIONS WITH UNDERLYING DISEASES IN THE FIELD OF UROLOGY |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42769 |
Study title: CLINICAL EVALUATION OF SBT/CFP FOR RESPIRATORY TRACT INFECTIONS IN PREMATURE BORN BABIES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42760 |
Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR HBTI COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42791 |
Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH DIGESTIVE MALIGNANT DISEASE |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42797 |
Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASE |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42798 |
Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH CEREBROVASCULAR DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42786 |
Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH DIGESTIVE MALIGNANT DISEASE |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42783 |
Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH GYNECOLOGICAL MALIGNANT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42814 |
Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42781 |
Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASE |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42820 |
Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT MALIGNANT DISEASES |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42782 |
Study title: A single-centre, randomised, double-blind, placebo-controlled pilot study of cross-over design testing nifedipine in patients with cystic fibrosis. |
Active substance: NIFEPIDINE |
Study summary document link (including results): Bayer Pharma_Nifedipine_1123_study_synopsis.pdf |
View full study record |
Document reference: 32631 |
Study title: A study to determine the effect of nifedipine (Adalat Retard) on early renal allograft function and cyclosoprin nephrotoxicity. |
Active substance: NIFEPIDINE |
Study summary document link (including results): |
View full study record |
Document reference: 32633 |
Study title: "DRUCKSENKUNG DER PULMONALEN HYPERTENSION DURCH BAYA1040, SUBLINGUAL, IM RAHMEN VON BRONCHOPULMONALER DYSPLASIE BEI KINDERN UNTER 2 JAHRE" |
Active substance: NIFEPIDINE |
Study summary document link (including results): |
View full study record |
Document reference: 32635 |
Study title: Open, non controlled, non randomised, unicenter pilot study to investigate the long-term efficacy of Adalat® drops and Adalat® retard 10 mg tablets in children with pulmonary hypertension and with peripheral pulmonary stenosis |
Active substance: NIFEPIDINE |
Study summary document link (including results): Bayer Pharma_Nifedipine_1555_study_synopsis.pdf |
View full study record |
Document reference: 32632 |
Study title: "PILOTSTUDIE: LANGZEITWIRKUNG VON ADALAT TROPFEN UND ADALAT RETARD BEI KINDERN MIT PULMONALER HYPERTONIE UND PERIPHEREN PULMONALSTENOSEN." |
Active substance: NIFEPIDINE |
Study summary document link (including results): |
View full study record |
Document reference: 32636 |
Study title: Dr. M. Chelly.Essai controle en ouvert evaluant l'efficacitè et la tolèrance du morniflumate suppositoire enfant versus alpha-amylase sirop dans les angines. |
Active substance: NIFLUMIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 32638 |
Study title: Report in Clinical documentation for Marketing Autorisation Application (June 1987): Evaluation of therapeutic efficacy and tolerability of teicoplanin in serious infections caused by Gram-positive micro-organisms - Terragna A. - 28 November 1985Report in Clinical documentation for Marketing Autorisation Application (June 1987): Evaluation of therapeutic efficacy and tolerability of teicoplanin in serious infections caused by Gram-positive micro-organisms - Terragna A. - 28 November 1985 |
Active substance: TEICOPLANIN |
Study summary document link (including results): Teicoplanin STUDY Serious infections - Terragna.xls |
View full study record |
Document reference: 44321 |
Study title: Graf et al. Ten days' Use of Oxymetazoline Nasal Spray With or Without Benzalkonium Chloride in Patients With Vasomotor Rhinits. Arch Otolaryngol Head Neck Surg 1999; 125: 1128-1132Graf et al. Ten days' Use of Oxymetazoline Nasal Spray With or Without Benzalkonium Chloride in Patients With Vasomotor Rhinits. Arch Otolaryngol Head Neck Surg 1999; 125: 1128-1132 |
Active substance: OXYMETAZOLINE |
Study summary document link (including results): |
View full study record |
Document reference: 33042 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Paeonia-Salbe-Heel (ointment) [AWB-AT] |
Active substance: Paeonia-Heel - Salbe |
Study summary document link (including results): |
View full study record |
Document reference: 40092 |
Study title: Study PALIOROS-PSZ-1001 is a multicenter, open-label, single- and multiple-dose study in subjects aged 10 to 17 years, inclusive, diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder to evaluate pharmcokinetics and tolerability. |
Active substance: PALIPERIDONE |
Study summary document link (including results): |
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Document reference: 45719 |
Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR INFLAMMATION OF PELVIC DEAD SPACE POST-OPERATION OF GYNECOLOGICAL MALIGNANT DISEASE. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42823 |
Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR RESPIRATORY TRACT INFECTION (RTI) OR SEPSIS COMPLICATED WITH LUNG CANCER |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42793 |
Study title: CLINICAL EVALUATION OF SULPERAZON (SP) FOR URINARY TRACT INFECTIONS (UTI) WITH UNDERLYING DISEASES IN THE FIELD OF UROLOGY. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42803 |
Study title: CLINICAL EVALUATION OF SULPERAZON AND PIPERACILLIN FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42838 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO-BILIARY TRACT MALIGNANT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42822 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42830 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42831 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42832 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42836 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42841 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42842 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42844 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT MALIGNANT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42827 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT MALIGNANT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42845 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASE |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42819 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42818 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42808 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT MALIGNANT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42816 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42811 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR INFECTIONS WITH TOTAL PARENTAL NUTRITION (T.P.N.) PATIENTS |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42776 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR POST-OPERATIVE INFECTIONS IN THE FIELD OF PLASTIC SURGERY. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42771 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY INFECTIONS (RTI) IN PATIENTS WITH UNDERLYING DISEASES (CHRONIC OBSTRUCTIVE PULMONARY DISEASE ETC.) |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42772 |
Study title: West syndrome: clinical and electroencephalographic follow up of 70 patients and response to its treatment with adrenocorticotropic hormone, prednisone, vigabatrin, nitrazepam and valproate. |
Active substance: NITRAZEPAM |
Study summary document link (including results): |
View full study record |
Document reference: 32651 |
Study title: Nitrix oxide for inhalation, INOMAX® INOT22 1-Year and 3-Year Follow up report: comparison of supplemental Oxygen and nitric oxide for inhalation plus oxygen in the evaluation of the reactivity of the pulmonary vasculature during acute pulmonary vasodilator testing |
Active substance: Nitric oxide |
Study summary document link (including results): |
View full study record |
Document reference: 41519 |
Study title: Evaluation of pharmacokinetics, safety, efficacy and acceptability of HMR3647 (20mg/kg and 30mg/kg q.d.) in pediatric patients with infection (a non-blind, randomised, parallel-group comparative study) |
Active substance: telithromycin |
Study summary document link (including results): |
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Document reference: 41572 |
Study title: Evaluation of telithromycin on acute otitis media in an experimental animal model (chinchilla) |
Active substance: telithromycin |
Study summary document link (including results): |
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Document reference: 41563 |
Study title: Evaluation of the Safety, Efficacy, Pharmacokinetics and Acceptability of HMR 3647 20 mg/kg QD for 5 Days with Acute Otitis Media in Children(Multicenter, open label, non comparative study) |
Active substance: telithromycin |
Study summary document link (including results): |
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Document reference: 41574 |
Study title: Evaluation of the Safety, Pharmacokinetics, Efficacy and Acceptability of HMR 3647 20mg/kg QD for 5-7 Days with Community Acquired Pneumonia (CAP) in children. (Multicenter, open label, non comparative study) |
Active substance: telithromycin |
Study summary document link (including results): |
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Document reference: 41573 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTION (RTI) WITH UNDERLYING DISEASES (CHRONIC OBSTRUCTIVE PULMONARY DISEASES, ETC.) |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42768 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42792 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) IN PATIENTS WITH UNDERLYING DISEASES (COPD). |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42809 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) IN PATIENTS WITH UNDERLYING DISEASES (COPD ETC.). |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42817 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS COMPLICATED WITH STOMACH CANCER OR COLON CANCER |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42824 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH CEREBROVASCULAR DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42834 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42778 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42801 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42840 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) COMPLICATED WITH LUNG CANCER. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42843 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) IN PATIENTS WITH UNDERLYING DISEASES (COPD ETC.) |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42837 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) OR SEPSIS COMPLICATED WITH LUNG CANCER. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42828 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) WITH UNDERLYING DISEASE (COPD ETC.) |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42821 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS (RTI) IN PATIENTS WITH UNDERLYING DISEASES (CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ETC.) |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42835 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR RESPIRATORY TRACT INFECTIONS IN PATIENTS WITH UNDERLYING DISEASES (CHRONIC OBSTRUCTIVE PULMONARY DISEASES, ETC.). |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42765 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE INFECTIONS COMPLICATED WITH GYNECOLOGICAL MALIGNANT DISEASE, ETC. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42775 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE INFECTIONS COMPLICATED WITH THE MALIGNANT DISEASES IN THE FIELD OF E.N.T. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42800 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE INFECTIONS IN THE FIELD OF INTENSIVE CARE UNIT. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42810 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS COMPLICATED WITH DIGESTIVE SYSTEM MALIGNANT DISEASE |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42767 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS IN THE FIELD OF ENT. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42780 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS IN THE FIELD OF ENT. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42784 |
Study title: Selzer RR, Rosenblatt DS, Laxova R, Hogan K. Adverse effect of nitrous oxide in a child with 5,10-methylenetetrahydrofolate reductase deficiency. New England Journal of Medicine. 2003; 349(1):45-50. Selzer RR, Rosenblatt DS, Laxova R, Hogan K. Adverse effect of nitrous oxide in a child with 5,10-methylenetetrahydrofolate reductase deficiency. New England Journal of Medicine. 2003; 349(1):45-50. |
Active substance: NITROUS OXIDE |
Study summary document link (including results): |
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Document reference: 32671 |
Study title: Pattern of killing of telithromycin and azithromycin against various strains of Streptococcus pneumoniae |
Active substance: telithromycin |
Study summary document link (including results): |
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Document reference: 41561 |
Study title: Evaluation of Prednisone, Vincristine and Teniposide Combination Therapy for Refractory Childhood Lymphocytic Leukemia |
Active substance: TENIPOSIDE |
Study summary document link (including results): teniposide 106-020.pdf |
View full study record |
Document reference: 46912 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS IN THE FIELD OF PLASTIC SURGERY. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42802 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS IN THE FIELD OR UROLOGY. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42787 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS IN THE FIELD OF UROLOGY. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42789 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
View full study record |
Document reference: 42785 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR THE POST-OPERATIVE PERITONITIS THE FIELD OF GYNECOLOGIA |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42770 |
Study title: CLINICAL EVALUATION OF SULPERAZON FOR UTI WITH UNDERLYING DISEASES IN THE FIELD OF UROLOGY |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42764 |
Study title: CLINICAL EVALUATION OF SULPERAZONE FOR HBTI COMPLICATED WITH HEPATO- BILIARY TRACT DISEASES. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42833 |
Study title: CLINICAL EVALUATION OF SULPERAZONE FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASE |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42812 |
Study title: CLINICAL EVALUATION OF SULPERAZONE FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT DISEASES |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42807 |
Study title: CLINICAL EVALUATION OF SULPERAZONE FOR INFECTIONS COMPLICATED WITH HEPATO-BILIARY TRACT MALIGNANCY DISEASES |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42804 |
Study title: CLINICAL EVALUATION OF UNASYN-SIV IN THE TREATMENT OF PERFORATIVE PERITONITIS. |
Active substance: SULBACTAM |
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Document reference: 42713 |
Study title: CLINICAL EVALUATION SULPERAZON (SP) FOR INFECTIONS COMPLICATED WITH CNS DISEASES SUCH AS CEREBROVASCULAR DISORDERS |
Active substance: SULBACTAM |
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Document reference: 42774 |
Study title: CLINICAL TRIAL OF SULPERAZON (SP) PLUS FOSFOMYCIN/ARBEKACIN/VANCOMYCIN FOR MRSA AND GRAM NEG RODS INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42766 |
Study title: Constant I, Abbas M, Boucheseiche S, Laude D, Murat I. Non-invasive assessment of cardiovascular autonomic activity induced by brief exposure to 50% nitrous oxide in children. Br J Anaesth 2002;88(5):637-43. |
Active substance: NITROUS OXIDE AND OXYGEN |
Study summary document link (including results): |
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Document reference: 32683 |
Study title: Evans JK, Buckley SL, Alexander AH, Gilpin AT. Analgesia for the reduction of fractures in children: A comparison of nitrous oxide with intramuscular sedation. J Pediatr Orthop 1995 Jan-Feb;15(1):73-7. |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32687 |
Study title: Gall O, Annequin D, Benoit G, Van Glabeke E, Vrancea F, Murat I. Adverse events of premixed nitrous oxide and oxygen for procedural sedation in children. Lancet 2001;358:1514-15. |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32692 |
Study title: Gregory PR, Sullivan JA. Nitrous oxide compared with intravenous regional anesthesia in pediatric forearm fracture manipulation. J Pediatr Orthop 1996;16:187-191. |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32694 |
Study title: EVALUATIONS OF TOLERABILITY AND EFFICACY OF ORAL SF 86-327 IN CHILDREN TREATED FOR FUNGAL INFECTIONS. A SUMMARY OF DATA FROM EXPERIENCE OTHER THAN SPECIAL CLINICAL TRIALS IN CHILDREN |
Active substance: TERBINAFINE |
Study summary document link (including results): SFE700MR.xls |
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Document reference: 44357 |
Study title: Jones, 1995: overview of six clinical studies, 152 children were evaluated for efficacy, 196 for tolerability. |
Active substance: TERBINAFINE |
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Document reference: 44342 |
Study title: PILOT STUDY OF TERBINAFINE IN CHILDREN SUFFERING FROM TINEA CAPITIS: EVALUATION OF THE EFFICACY, SAFETY AND PHARMACOKINETICS SHORT TITLE: LAMISIL(R) _ EFFICACY, SAFETY, PHARMACOKINETICS IN CHILDREN |
Active substance: TERBINAFINE |
Study summary document link (including results): SFE 306MR.xls |
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Document reference: 44353 |
Study title: Study 2 - Jones, 1995: overview of six clinical studies, 152 children were evaluated for efficacy, 196 for tolerability. |
Active substance: TERBINAFINE |
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Document reference: 44345 |
Study title: TO EVALUATE THE EFFICACY AND SAFETY OF A SINGLE ORAL DOSE OF 2.25 GM OF STM & PRABENECID 1 GM WITH AND WITHOUT PROBENECIDE IN THE TREATMENT OF GONORRHEA. |
Active substance: SULTAMICILLIN |
Study summary document link (including results): |
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Document reference: 43062 |
Study title: TO EVALUATE THE EFFICACY AND SAFETY OF SBT/AMP/STM IN THE TREATMENT OF (RTI) RESPIRATORY TRACT INFECTIONS. |
Active substance: SULTAMICILLIN |
Study summary document link (including results): |
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Document reference: 42951 |
Study title: TO EVALUATE THE EFFICACY AND SAFETY OF SULTAMICILLIN IN THE TREATMENT OF PATIENTS WITH LOWER RESPIRATORY TRACT INFECTIONS. |
Active substance: SULTAMICILLIN |
Study summary document link (including results): |
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Document reference: 43012 |
Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF STM (SBT/AMP) GIVEN ORALLY BID IN PEDIATRIC INFECTIONS. |
Active substance: SULTAMICILLIN |
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Document reference: 42982 |
Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF STM GIVEN ORALLY BID IN PEDIATRIC INFECTIONS. |
Active substance: SULTAMICILLIN |
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Document reference: 42981 |
Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF STM IN THE TREATMENT OF PATIENTS WITH DIAGNOSED CASES OF UTI. |
Active substance: SULTAMICILLIN |
Study summary document link (including results): |
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Document reference: 43060 |
Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF SULTAMICILLIN GIVEN ORALLY TWICE A DAY IN PEDIATRIC INFECTIONS. |
Active substance: SULTAMICILLIN |
Study summary document link (including results): |
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Document reference: 42983 |
Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF SULTAMICILLIN IN THE TREATMENT OF A VARIETY OF CHILDHOOD INFECTIONS, E.G., OTITIS MEDIA. |
Active substance: SULTAMICILLIN |
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Document reference: 43061 |
Study title: TO EVALUATE THE EFFICACY OF STM IN THE TREATMENT OF PATIENTS WITH DIAGNOSED CASES OF BRONCHO-PNEUMONIA. |
Active substance: SULTAMICILLIN |
Study summary document link (including results): |
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Document reference: 43059 |
Study title: Kanagasundaram SA, Lane LJ, Cavalletto BP, Keneally JP, Cooper MG. Efficacy and safety of nitrous oxide in alleviating pain and anxiety during painful procedures. Arch Dis Child 2001;84:492-495. |
Active substance: NITROUS OXIDE AND OXYGEN |
Study summary document link (including results): |
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Document reference: 32702 |
Study title: Selzer RR, Rosenblatt DS, Laxova R, Hogan K. Adverse effect of nitrous oxide in a child with 5,10-methylenetetrahydrofolate reductase deficiency. N Engl J Med 2003;349:45-50. |
Active substance: NITROUS OXIDE AND OXYGEN |
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Document reference: 32709 |
Study title: In Vitro Evaluation of Allergic Reactions in hemophilia B Subjects who have Exhibited a Systemic Allergic Response after Exposure to BeneFIX (Nonacog Alfa; recombinant Factor IX) |
Active substance: NONACOG ALFA |
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Document reference: 41496 |
Study title: J. Dimpfl, W. Salomon, K.-H. Schicketanz: The sperizidal barrier. Sexualmedizin 13; 95-98 (1984) J.Balmer, P.Hartmann, K.-H Schicketanz: Sexual behaviour during intravaginal contraception. Sexualmedizin 15: 244-248 (1986) |
Active substance: NONOXINOL-9 |
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Document reference: 32720 |
Study title: W. Salomon, W. Haase: Intravaginal contraception. Results of a prospective long-term study of the foam ovoid. Sexualmedizin 6; 198-202(1977) |
Active substance: NONOXINOL-9 |
Study summary document link (including results): |
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Document reference: 32718 |
Study title: An evaluation of the respiratory and cardiovascular effects of oral terbutaline in asthmatic pediatric children. |
Active substance: TERBUTALINE |
Study summary document link (including results): |
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Document reference: 44390 |
Study title: Clinical Trial to evaluate the efficacy of terbutaline in preventing exercise induced asthma when administered to children via the spacer aerosol. |
Active substance: TERBUTALINE |
Study summary document link (including results): CSR 01-6032.pdf |
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Document reference: 44435 |
Study title: GM1997/00059/00 An open design study to evalute repeat dose oral sumatriptan 100mg in the acute treatment of adolescent migraine during a six month period. |
Active substance: SUMATRIPTAN |
Study summary document link (including results): Sumatriptan-SUMB3005-ICHE3.pdf |
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Document reference: 43081 |
Study title: GM2002/00080/00 Single centre, placebo controlled, double blind randomised crossover, single attack study evaluating the efficacy and tolerability of sumatriptan nasal spray 10mg for the acute treatment of migraine in children suffering from refractory migraine |
Active substance: SUMATRIPTAN |
Study summary document link (including results): Sumatriptan-SUM30009-ICHE3.pdf |
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Document reference: 43072 |
Study title: RM1998/00017/00 A double blind placebo controlled parallel group study to evaluate three dose levels (5mg, 10mg and 20mg) of sumatripaten nasal spray in the acute treatment of a single migraine attack in adolescent migraineurs (12-17 yrs of age). |
Active substance: SUMATRIPTAN |
Study summary document link (including results): Sumatriptan-SUMA3005-ICHE3.pdf |
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Document reference: 43078 |
Study title: RM1998/00018/00 An open label study to evaluate the long term safety, tolerability and efficacy of sumatriptan nasal spray in the acute treatment of mutiple migraine attacks in adolescent migraineurs (12-17 yrs of age). |
Active substance: SUMATRIPTAN |
Study summary document link (including results): Sumatriptan-SUMA3006-ICHE3.pdf |
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Document reference: 43079 |
Study title: RM2003/00271/00 A double blind placebo controlled, parallel group study to evaluate two dose levels (5mg and 20mg) of sumatriptan nasal spray in the acute treatment of a single migraine attack in adolescent migraineurs (12-17 yrs). |
Active substance: SUMATRIPTAN |
Study summary document link (including results): Sumatriptan-SUM30045-ICHE3.pdf |
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Document reference: 43073 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Syzygium compositum (drops) [AWB-AT] |
Active substance: Syzygium compositum-Heel - Tropfen |
Study summary document link (including results): |
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Document reference: 40250 |
Study title: EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN IN VARIOUS INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42742 |
Study title: EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN IN VARIOUS INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42743 |
Study title: EFFICACY OF SBT.AMP IN VARIOUS INFECTIONS IN CHILDREN. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42741 |
Study title: OPEN NON-COMPARATIVE EVALUATION IN THE PROPHYLAXIS OF SURGICAL WOUND INFECTIONS |
Active substance: SULBACTAM |
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Document reference: 42684 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Nux vomica-Homaccord (drops) [AWB-006] |
Active substance: Nux vomica-Homaccord |
Study summary document link (including results): |
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Document reference: 40084 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Nux vomica-Homaccord (drops) [AWB-AT] |
Active substance: Nux vomica-Homaccord |
Study summary document link (including results): |
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Document reference: 40085 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Nux vomica-Homaccord (injection solution) [AWB-081] |
Active substance: Nux vomica-Homaccord |
Study summary document link (including results): |
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Document reference: 40086 |
Study title: De Wet PM, Rode H, van Dyk A, Millar AJ W: Perianal Canidosis-a comparative study with mupirocin and nystatin. Int J Dermatol 1999;38(8):618-22.De Wet PM, Rode H, van Dyk A, Millar AJ W: Perianal Canidosis-a comparative study with mupirocin and nystatin. Int J Dermatol 1999;38(8):618-22. |
Active substance: NYSTATIN |
Study summary document link (including results): |
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Document reference: 32728 |
Study title: A Phase 2, Randomized, Double-Blind Study To Evaluate the Dosing Concentration and Application Frequency of Tacrolimus Gel in the Treatment of Mild to Moderate Psoriasis in Pediatric and Adult subjects |
Active substance: Tacrolimus |
Study summary document link (including results): |
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Document reference: 41599 |
Study title: A Phase 3 Long-Term Open Label Study to Evaluate the Safety ofOnce Daily 0.3% Tacrolimus Gel in the Treatment of Psoriasis - |
Active substance: Tacrolimus |
Study summary document link (including results): |
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Document reference: 41603 |
Study title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Once Daily 0.3% FK506 Gel Versus Gel Vehicle in the Treatment of Psoriasis - |
Active substance: Tacrolimus |
Study summary document link (including results): |
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Document reference: 41601 |
Study title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Once Daily 0.3% Tacrolimus Gel Versus Gel Vehicle in the Treatment of Psoriasis - |
Active substance: Tacrolimus |
Study summary document link (including results): |
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Document reference: 41600 |
Study title: An open-label study to evaluate the safety of topically applied tacrolimus ointment for the treatment of atopic dermatitis. |
Active substance: Tacrolimus |
Study summary document link (including results): |
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Document reference: 47776 |
Study title: Phase 3, randomized, double-blind, multi-center, vehicle-controlled, parallel, two-treatment group study stratified by baseline PSGA and investigative site to evaluate the efficacy and safety of tacrolimus cream 0.03% applied twice daily (bid) compared to cream vehicle applied bid for the treatment of atopic dermatitis. |
Active substance: Tacrolimus |
Study summary document link (including results): |
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Document reference: 47772 |
Study title: OPEN, NON-COMPARATIVE STUDY OF THE EFFICACY, SAFETY AND TOLERABILITY OF SBT/AMP IMIV IN THE TREATMENT OF PEDIATRICS WITH VARIOUS BACTERIAL INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42689 |
Study title: THE EVALUATION OF CLINICAL EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN (UNASYN) IN THE TREATMENT OF COMMUNITY-ACQUIRED INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42750 |
Study title: Observational use study of the tolerability of Octenisept in premature infants with a gestational age of less than 27 weeks, at the Department of Neonatology of the Charite Campus Virchow Clinic.(Director: Prof. Dr. med. Michael Obladen.2002. |
Active substance: OCTENIDINE |
Study summary document link (including results): |
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Document reference: 32734 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Oculoheel (tablets) [AWB-AT] |
Active substance: Oculoheel |
Study summary document link (including results): |
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Document reference: 40087 |
Study title: Oral nystatin profilaxis to prevent invasive candidiasis in neonatal intensive care unit 2006 |
Active substance: NYSTATIN |
Study summary document link (including results): |
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Document reference: 41622 |
Study title: Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396 Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396 |
Active substance: OBIDOXIME |
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Document reference: 32732 |
Study title: Observational study of the use of Octenisept on babies and neonates at the Pediatric Clinic of Gera Hospital.1996. |
Active substance: OCTENIDINE |
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Document reference: 32738 |
Study title: Group B strepto-coccus induces tumor necrosis factor in neonatal piglets: Effect of the tumor necrosis factor inhibitor pentoxifylline on haemodynamics and gas exchange. Am. Rev. Respir. Dis. 143:598-604 - Gibson - 1991 - Publication in pharmacological-toxicological expert reportGroup B strepto-coccus induces tumor necrosis factor in neonatal piglets: Effect of the tumor necrosis factor inhibitor pentoxifylline on haemodynamics and gas exchange. Am. Rev. Respir. Dis. 143:598-604 - Gibson - 1991 - Publication in pharmacological-toxicological expert report |
Active substance: PENTOXYFILLINE |
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Document reference: 45844 |
Study title: Pentoxifylline reduces ventilatory disturbances in experimental meconium aspiration. Annual meeting of the pediatric societies, Balimore. Ped Research. 51, n°4 Part 2: 394A - Kohonen - April 2002 - Publication in NDA Annual Report -Pentoxifylline reduces ventilatory disturbances in experimental meconium aspiration. Annual meeting of the pediatric societies, Balimore. Ped Research. 51, n°4 Part 2: 394A - Kohonen - April 2002 - Publication in NDA Annual Report - |
Active substance: PENTOXYFILLINE |
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Document reference: 45845 |
Study title: Pharmacokinetic and tolerability assessment of a pediatric oral formulation of pentoxifylline in Kawasaki disease. Current-Ther-research,64;2:96-115 - Best-Brookie - February 2003 - Publication in NDA Annual Report -Pharmacokinetic and tolerability assessment of a pediatric oral formulation of pentoxifylline in Kawasaki disease. Current-Ther-research,64;2:96-115 - Best-Brookie - February 2003 - Publication in NDA Annual Report - |
Active substance: PENTOXYFILLINE |
Study summary document link (including results): |
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Document reference: 45846 |
Study title: TIME-LAG COMBINED THERAPY OF SULPERAZON (SP) AND FOSFOMYCIN (FOM) FOR INFECTIONS COMPLICATED WITH CNS DISEASES SUCH AS CEREBROVASCULAR DISORDER |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42794 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Oculoheel (eye drops) [AWB-099] |
Active substance: Oculoheel |
Study summary document link (including results): |
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Document reference: 40089 |
Study title: A 26-week, randomized, multicenter, parallel-group, double-blind, vehicle-controlled study to evaluate the incidence of atopic dermatitis flares when ASM981 (pimecrolimus) cream 1% is used at the first signs and/or symptoms of atopic dermatitis and its safety and tolerability in children and adolescents 2 - 17 years of age |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981C2406 Art45 listing 2011.xls |
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Document reference: 34132 |
Study title: A 27 week study, 3 week randomized, multicenter, double blind, parallel group, vehicle control and 24 week open label phase, to evaluate efficacy , tolerability and safety, of ASM 981 (pimecrolimus) cream 1% in pediatric patients with mild to moderate atopic dermatitis in face |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981MX01 Art45 listing 2011.xls |
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Document reference: 34099 |
Study title: TO EVALUATE THE CLINICAL AND BACTERIOLOGICAL EFFICACY, SAFETY AND TOLERABILITY OF SULBACTAM/AMPICILLIN IN THE TREATMENT OF SKIN/SOFT TISSUE INFECTIONS OF BACTERIAL ETIOLOGY. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42746 |
Study title: TO EVALUATE THE CLINICAL AND BACTERIOLOGICAL EFFICACY, SAFETY AND TOLERATION OF UNASYN IM/IV IN VARIOUS INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42687 |
Study title: TO EVALUATE THE CLINICAL EFFICACY OF S/S IN HOSPITALIZED PATIENT WITH URINARY TRACT INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42682 |
Study title: TO EVALUATE THE EFFICACY AND SAFETY OF SULBACTAM/AMPICILLIN IN THE TREATMENT OF GYNECOLOGICAL INFECTIONS OF BACTERIAL ETIOLOGY, INCLUDING, BUT NOT NECESSARILY LIMITED TO: PELVIC INFLAMMATORY DISEASE, ENDOMETRITIS, SALPINGITIS, BARTHELINITIS, ETC. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42716 |
Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF SBT/AMP GIVEN IM TWICE A DAY IN NON-SEVERE INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42724 |
Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF SULBACTAM/AMPICILLIN GIVEN INTRAMUSCULARLY THREE/FOUR TIMES PER DAY TO PATIENTS WITH VARIOUS INFECTIONS. |
Active substance: SULBACTAM |
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Document reference: 42715 |
Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF SULBACTAM/AMPICILLIN GIVEN INTRAVENOUSLY EVERY 8 HOURS COMPARED TO NETILMYCIN 100 MG, PLUS METRONIDAZOLE TWO TIMES A DAY IN THE TREATMENT OF PATIENTS WITH INTRA ABDOMINAL INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42708 |
Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF SULBACTAM/AMPICILLIN IM/IV IN THE TREATMENT OF SURGICAL INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42714 |
Study title: TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SBT/AMP IN THE TREATMENT OF MODERATE TO SEVERE SKIN/SOFT TISSUE OR BACTERIAL |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42748 |
Study title: TO EVALUATE THE EFFICACY, SAFETY AND TOLERATION OF SBT/AMP IN THE TREATMENT OF BACTERIAL INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42747 |
Study title: TO EVALUATE THE SAFETY AND EFFICACY OF SULBACTAM/AMPICILLIN COMPARED TO CEFOTETAN IN THE TREATMENT OF BACTERIAL ETIOLOGY INFECTIONS. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42697 |
Study title: UNASYN IM/IV, OPEN, NON COMPARATIVE EVALUATION IN THE TREATMENT OF ACUTE AND CHRONIC INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42683 |
Study title: Open-Label Study of Olanzapine in Children with Pervasive Developmental Disorder |
Active substance: OLANZAPINE |
Study summary document link (including results): |
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Document reference: 32761 |
Study title: A Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of a Compounded 4 mg/mL Olmesartan Medoxomil Suspension (Total Dose 40 mg) and 40 mg Olmesartan Medoxomil Tablets (Benicar®) in Healthy Adult Volunteers Under Fasting Conditions |
Active substance: OLMESARTAN MEDOXOMIL |
Study summary document link (including results): |
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Document reference: 32762 |
Study title: An Open-Label Study of the Single-Dose Pharmacokinetics of Olmesartan Medoxomil in Pediatric Patients with Hypertension |
Active substance: OLMESARTAN MEDOXOMIL |
Study summary document link (including results): |
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Document reference: 32763 |
Study title: Dose-Ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents with Hypertension |
Active substance: OLMESARTAN MEDOXOMIL |
Study summary document link (including results): |
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Document reference: 32764 |
Study title: A bioavailability study of omeprazole comparing three different liquid formulations after single dose administration to healthy volunteers, 17 November 1996 |
Active substance: OMEPRAZOLE |
Study summary document link (including results): |
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Document reference: 41623 |
Study title: A Multi-Center, Open-Label Study to Evaluate Omeprazole for the Treatment of Gastrointestinal Symptoms Associated with Acid-Related Disorders in Pediatric Subjects (Ages 2 through 16 years, Inclusive), 9 August 2000 |
Active substance: OMEPRAZOLE |
Study summary document link (including results): |
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Document reference: 32788 |
Study title: Immuntherapie bei kindern mit hilfe eines multibakteriellen ribosomenpräparates |
Active substance: Tetanus Vaccine (Adsorbed) |
Study summary document link (including results): |
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Document reference: 41393 |
Study title: Christensen LA, Fallingborg J, Jacobson BA, " Bioavailability of 5-aminosalicylic acid from slow release 5-aminosalicylic acid drug and sulfasalasine in normal children." Did Dis Sci 38 (1993) 1831-1836Christensen LA, Fallingborg J, Jacobson BA, " Bioavailability of 5-aminosalicylic acid from slow release 5-aminosalicylic acid drug and sulfasalasine in normal children." Did Dis Sci 38 (1993) 1831-1836 |
Active substance: SULFASALAZINE |
Study summary document link (including results): |
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Document reference: 42877 |
Study title: A Multicenter, Randomized Open-Label, Pharmacokinetics and pH Assessment Study to Evaluate a Single Dose of Omeprazole in a Pediatric Population Ages 0 Months – 24 Months, Inclusive, 3 January 2001 |
Active substance: OMEPRAZOLE |
Study summary document link (including results): |
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Document reference: 32790 |
Study title: A Multicenter, Randomized, Single-Blind Study to Evaluate Omeprazole for the Treatment of Clinically Diagnosed GERD in Pediatric Patients Ages 0 months through 24 months, Inclusive, 18 October 2000 |
Active substance: OMEPRAZOLE |
Study summary document link (including results): |
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Document reference: 32791 |
Study title: A Multicenter, Retrospective Study to Evaluate the Effect of Multiple Doses of Omeprazole on Gastric or Esophageal pH in a Pediatric Population, 17 November 2000 |
Active substance: OMEPRAZOLE |
Study summary document link (including results): |
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Document reference: 32792 |
Study title: A Randomized, Single-Center, Open-label, Two-period Crossover, Pharmacokinetic Study to Evaluate the Bioequivalence of a Single 20 mg Omeprazole Dose Administered as an Intact Capsule and as an Open Capsule in Healthy Male and Female Volunteers, 30 September 1999 |
Active substance: OMEPRAZOLE |
Study summary document link (including results): |
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Document reference: 32787 |
Study title: An Open-label, Multicenter, Pharmacokinetic Study to Evaluate the Bioavailability of a Single Dose of Omeprazole in a Pediatric Population, 7 March 2000 |
Active substance: OMEPRAZOLE |
Study summary document link (including results): |
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Document reference: 32786 |
Study title: An Open-label, Multicenter, Pharmacokinetic Study to Evaluate the Bioavailability of Single and Multiple Doses of Omeprazole in a Pediatric Population, 23 May 2000 |
Active substance: OMEPRAZOLE |
Study summary document link (including results): |
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Document reference: 32789 |
Study title: Evaluation of the role of acidic and non-acidic reflux in recurrent respiratory and chronic ear, nose,and throat (ENT) diseases in children by using multichannel intraluminal impedance (MII) apparatus |
Active substance: OMEPRAZOLE |
Study summary document link (including results): |
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Document reference: 32778 |
Study title: Omeprazole in children with reflux esophagitis-an open dose finding study and an evaluation of the safety and efficacy during maintenance treatment. Interim report 1996 |
Active substance: OMEPRAZOLE |
Study summary document link (including results): |
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Document reference: 32794 |
Study title: Havas L: DOSAGE OF PHARMACEUTICALS IN CHILDREN B-0054340 |
Active substance: Sulfamethoxazole trimethoprim |
Study summary document link (including results): |
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Document reference: 45251 |
Study title: M. Sieniawska ,,Clinical evaluation of the prep. Biseptol 480 for i.v. use in children with bacterial infections" |
Active substance: Sulfamethoxazole trimethoprim |
Study summary document link (including results): |
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Document reference: 45242 |
Study title: Subconjunctival bupivacaine versus topical amethocaine in strabismus surgery. Habib NE, el-Kasaby HT, Marczak AM, Hsuan J. Eye. 1993;7 ( Pt 6):757-9. Subconjunctival bupivacaine versus topical amethocaine in strabismus surgery. Habib NE, el-Kasaby HT, Marczak AM, Hsuan J. Eye. 1993;7 ( Pt 6):757-9. |
Active substance: TETRACAINE |
Study summary document link (including results): Subconjunctival bupivacaine versus topical amethocaine in strabismus surgery. Habib NE, el-Kasaby HT, Marczak AM, Hsuan J. Eye. 1993;7.pdf |
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Document reference: 44447 |
Study title: Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 43391 |
Study title: Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44148 |
Study title: Publication in NDA Annual Report: Inhibition of meconium induced activation of granulocytes from neonates and adults by pentoxifylline. - Klin -Padiatr. 214(6): 347-52 - Tegtmeyer - Nov-Dec 2002Publication in NDA Annual Report: Inhibition of meconium induced activation of granulocytes from neonates and adults by pentoxifylline. - Klin -Padiatr. 214(6): 347-52 - Tegtmeyer - Nov-Dec 2002 |
Active substance: PENTOXYFILLINE |
Study summary document link (including results): |
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Document reference: 45847 |
Study title: Clinical study;Administration of Sedotussin to infants and young children. Final evaluation and expert report involving 5,024 patients. |
Active substance: PENTOXYVERINE |
Study summary document link (including results): ARCE94C1701(2) - Pentoxyverine.pdf |
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Document reference: 47360 |
Study title: Open, single-dose, phase i study to evaluate the pharmacokinetic parameters of pentoxyverine and its major metabolites in plasma and urine of children with upper respiratory tract infection. |
Active substance: PENTOXYVERINE |
Study summary document link (including results): 9738 - Pentoxyverine - MRCE99K0801.pdf |
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Document reference: 45861 |
Study title: Chiang. Chronic duodenal ulcer in children: clinical observation and response to treatment. J Pediatr Gastroenterol Nutr 1989; 8: 161-165. Chiang. Chronic duodenal ulcer in children: clinical observation and response to treatment. J Pediatr Gastroenterol Nutr 1989; 8: 161-165. |
Active substance: SUCRALFATE |
Study summary document link (including results): |
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Document reference: 42607 |
Study title: Nedocromil sodium (FPL 59002KP) Safety evaluation - Summary of safety evaluation studies SE 5660/7, January 1987 |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47020 |
Study title: Nedocromil sodium Safety evaluation- Summary of safety evaluation studies- B. Clark- 01/ 1987 - Publication in Product licence application TILADE MINT AEROSOL (nedocromil sodium) - Pre Clinical documentation -29/08/1995 - |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47007 |
Study title: Prevalence of asthma in Melbourne schoolchildren : changes over 26 years - CF. Robertson et al. - 1991 (BMJ vo l 302) - Publication in Tilade metered-dose inhaler (nedocromil sodium 2 mg) - Clinical expert report for extension of use in children- clinical documentation - K. Rocchiccioli - 24/06/1994 - |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47024 |
Study title: Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 44195 |
Study title: Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. Yildiz M, Tunc SE, Sahin M, Okudan B, Aydin O, Suslu H, Ozbek M. Evaluation of joints using Tc 99m-MDP bone scintigraphy in patients with familial Mediterranean fever: should bone scans be used for diagnosis and follow-up? Rheumatol Int. 2006 Jan;26(3):220-3. Epub 2005 Feb 3. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 44242 |
Study title: Yilmaz M, Yilmaz K, Celen Z, Sirikci A, Ozkiliç S, Zincirkeser S. Bilateral symmetrically increased Tc-99m MDP cranial uptake in Hurler syndrome. Clin Nucl Med. 2002 Dec;27(12):915. No abstract available. Yilmaz M, Yilmaz K, Celen Z, Sirikci A, Ozkiliç S, Zincirkeser S. Bilateral symmetrically increased Tc-99m MDP cranial uptake in Hurler syndrome. Clin Nucl Med. 2002 Dec;27(12):915. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43427 |
Study title: Yoffe N, Besser MI, Sobel JD, Front D. [Early diagnosis of pyogenic sacroiliac infection using 67-gallium scintigram] Harefuah. 1983 Jan 16;104(2):55-6. Hebrew. No abstract available. Yoffe N, Besser MI, Sobel JD, Front D. [Early diagnosis of pyogenic sacroiliac infection using 67-gallium scintigram] Harefuah. 1983 Jan 16;104(2):55-6. Hebrew. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44052 |
Study title: A 3 week randomized, multicenter, double blind, vehicle-controlled, parallel-group study to evaluate the efficacy and safety of Pimecrolimus cream 1% in children between 2-12 years with mild to moderate atopic dermatitis (Speed Study) |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CES02 Art45 listing 2011.xls |
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Document reference: 34103 |
Study title: A 6-month, randomized, multi-center, parallelgroup, double-blind, vehicle controlled study to evaluate the efficacy and safety of ASM981 (pimecrolimus) cream 1% BID vs. standard of care in the management of mild to moderate atopic dermatitis in children 3 months to 11 years. |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CUS04 Art45 listing 2011.xls |
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Document reference: 47706 |
Study title: The combination sufentanil-bupivascaine in post-operative patient controlled epidural analgesia. Von H. LuewenThe combination sufentanil-bupivascaine in post-operative patient controlled epidural analgesia. Von H. Luewen |
Active substance: SUFENTANYL |
Study summary document link (including results): |
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Document reference: 42623 |
Study title: Publication in Nedocromil sodium HFA-227-metered dose inhaler -Expert report on clinical documentation -Critical evaluation - H. Staudinger - 09/04/1998 |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47042 |
Study title: Safety evaluation - Dentomint : Summary of toxicité - Publication in Product licence application TILADE MINT AEROSOL (nedocromil sodium) - Pre Clinical documentation -29/08/1995 - |
Active substance: NEDOCROMIL |
Study summary document link (including results): |
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Document reference: 47013 |
Study title: Caudal ropivacaine and neostigmine in pediatric surgeryCaudal ropivacaine and neostigmine in pediatric surgery |
Active substance: NEOSTIGMINE |
Study summary document link (including results): |
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Document reference: 47048 |
Study title: Yu JQ, Zhuang H, Posteraro A, Reddy S, Alavi A. Transiently increased MDP activity in the soft tissue of lower extremity caused by iliofemoral venous thrombosis. Clin Nucl Med. 2005 Nov;30(11):742-3. No abstract available. Yu JQ, Zhuang H, Posteraro A, Reddy S, Alavi A. Transiently increased MDP activity in the soft tissue of lower extremity caused by iliofemoral venous thrombosis. Clin Nucl Med. 2005 Nov;30(11):742-3. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43383 |
Study title: Yui N, Kinoshita F, Akiyama Y, Koakutsu M, Umeda T. [Clinical evaluation of transaxial bone imaging with 99mTc-phosphate compounds] Radioisotopes. 1982 Oct;31(10):521-8. Japanese. Yui N, Kinoshita F, Akiyama Y, Koakutsu M, Umeda T. [Clinical evaluation of transaxial bone imaging with 99mTc-phosphate compounds] Radioisotopes. 1982 Oct;31(10):521-8. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44069 |
Study title: Unusual bone scan of a child with osteogenesis imperfecta. Yurekli Y, Erdogan S, Cullu E. Clin Nucl Med. 2003 Feb;28(2):156. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43429 |
Study title: Zebedin D, Fotter R, Reittner P, Preidler KW, Mache C, Szolar DH. [Chronic recurrent multifocal osteomyelitis of the lower jaw] Rofo. 1998 Nov;169(5):551-4. German. No abstract available. Zebedin D, Fotter R, Reittner P, Preidler KW, Mache C, Szolar DH. [Chronic recurrent multifocal osteomyelitis of the lower jaw] Rofo. 1998 Nov;169(5):551-4. German. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43521 |
Study title: A double-blind, randomized, placebo-controlled, paired study to evaluate the efficacy and safety of combined use of Elidel and Cutivate in children with severe atopic dermatitis. |
Active substance: PIMECROLIMUS |
Study summary document link (including results): |
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Document reference: 47709 |
Study title: Tay-Uyboco JS, Kwiatkowski K, Cates DB, Kavanagh L, Rigatto H. Hypoxic airway constriction in infants of very low birth weight recovering from moderate to severe bronchopulmonary dysplasia. J Pediatr. 1989; 115:456–459.Tay-Uyboco JS, Kwiatkowski K, Cates DB, Kavanagh L, Rigatto H. Hypoxic airway constriction in infants of very low birth weight recovering from moderate to severe bronchopulmonary dysplasia. J Pediatr. 1989; 115:456–459. |
Active substance: OXYGEN |
Study summary document link (including results): |
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Document reference: 45411 |
Study title: Dose responses for neostigmine and edrophonium as antagonists of mivacurium in adults and children.Dose responses for neostigmine and edrophonium as antagonists of mivacurium in adults and children. |
Active substance: NEOSTIGMINE |
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Document reference: 47050 |
Study title: Kumar P et al.: Caudal additives in pediatrics: A comparison among midazolam, ketamine, and neostigmine coadministered with bupivacaine. Anesthesia and Analgesia ( Anesth. Analg. ) (United States) , July 1, 2005 , 101/1 (69-73) Kumar P et al.: Caudal additives in pediatrics: A comparison among midazolam, ketamine, and neostigmine coadministered with bupivacaine. Anesthesia and Analgesia ( Anesth. Analg. ) (United States) , July 1, 2005 , 101/1 (69-73) |
Active substance: NEOSTIGMINE |
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Document reference: 47055 |
Study title: Mahajan R.; Grover V.K.; Chari P.: Caudal neostigmine with bupivacaine produces a dose-independent analgesic effect in children. Canadian Journal of Anesthesia ( Can. J. Anesth. ) (Canada), August 1, 2004 , 51/7 (702-706) Mahajan R.; Grover V.K.; Chari P.: Caudal neostigmine with bupivacaine produces a dose-independent analgesic effect in children. Canadian Journal of Anesthesia ( Can. J. Anesth. ) (Canada), August 1, 2004 , 51/7 (702-706) |
Active substance: NEOSTIGMINE |
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Document reference: 47056 |
Study title: Turan A, Memiş D, Başaran UN, Karamanlioğlu B, Süt N.: Caudal ropivacaine and neostigmine in pediatric surgery. Anesthesiology. 2003 Mar;98(3):719-22.Turan A, Memiş D, Başaran UN, Karamanlioğlu B, Süt N.: Caudal ropivacaine and neostigmine in pediatric surgery. Anesthesiology. 2003 Mar;98(3):719-22. |
Active substance: NEOSTIGMINE |
Study summary document link (including results): |
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Document reference: 47058 |
Study title: Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396 |
Active substance: TEGAFUR/URACIL |
Study summary document link (including results): |
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Document reference: 44288 |
Study title: A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. Jan 1988.A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. Jan 1988. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
Study summary document link (including results): |
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Document reference: 33331 |
Study title: A PROSPECTIVE, RANDOMIZED, EVALUATION OF AMPICILLIN/SULBACTAM VS CLINDAMYCIN/GENTAMICIN FOR TREATMENT OF CHORIOAMNIONITIS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42668 |
Study title: AN OPEN EVALUATION OF SULBACTAM/AMPICILLIN IN THE MANAGEMENT OF CEREBRO-SPINAL MENINGITIS EMPIDERMICA. |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42757 |
Study title: Bouissou, 2008; PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).Prospective, Randomized Trial Comparing Short and Long Intravenous Antibiotic Treatment of Acute Pyelonephritis in Children: Dimercaptosuccinic Acid Scintigraphic Evaluation at 9 Months |
Active substance: NETILMICIN |
Study summary document link (including results): |
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Document reference: 32619 |
Study title: Contopoulos-Ioannidis et. Al ; PEDIATRICS Vol. 114 No. 1 July 2004 Extended-Interval Aminoglycoside Administration for Children: A Meta-analysis |
Active substance: NETILMICIN |
Study summary document link (including results): |
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Document reference: 32623 |
Study title: High levels of serum prostaglandin e2 in children with osteogenesis imperfecta are reduced by neridronate treatment. Not Available (study published in 2008) |
Active substance: NERIDRONIC ACID |
Study summary document link (including results): |
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Document reference: 47059 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Neuro-Injeel Ampullen (ampoules) [AWB-AT] |
Active substance: Neuro-Injeel Ampullen |
Study summary document link (including results): |
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Document reference: 40083 |
Study title: "The effect of continuous epidural analgesia with sufentanil and bupivacaine during and after thoracic surgery on the plasma cortisol concentration and pain relief" |
Active substance: NICOMORPHINE |
Study summary document link (including results): |
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Document reference: 32624 |
Study title: Efficacy of Tonsiotren for acute angina catarrhalis. |
Active substance: Per tablet: Atropinum sulfuricum D5 12,5 mg Hepar sulfuris D3 10,0 mg Kalium bichromicum D4 50,0 mg Silicea D2 5,0 mg Mercurius bijodatus D8 25,0 mg |
Study summary document link (including results): |
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Document reference: 39744 |
Study title: Study of high doses in infant psychiatry: neuroses, psychoses, evolving dysharmony, behaviour disorders. Dr R. Mises, fondation Vallee (Gentilly), 01/1970 - Study mentioned in the summary report - Doc. 000632 |
Active substance: PERICIAZINE |
Study summary document link (including results): |
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Document reference: 33893 |
Study title: 10 weeks toxicity study by oral route (gavage) in juvenile rats followed by a 3-week recovery period. |
Active substance: PERINDOPRIL |
Study summary document link (including results): |
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Document reference: 45866 |
Study title: 2 weeks toxicity study by oral route (gavage) in juvenile rats. Ongoing |
Active substance: PERINDOPRIL |
Study summary document link (including results): |
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Document reference: 45865 |
Study title: Acceptability, safety, pharmacokinetics and effects on blood pressure of a paediatric formulation of perindopril S 90652 (daily dose 0.025 to 0.135 mg/kg) in hypertensive children -an open, non comparative, 3-month then at least 24-months duration multicentre study. |
Active substance: PERINDOPRIL |
Study summary document link (including results): perindopril_CL2-90652-002_synopsis.pdf |
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Document reference: 45867 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF UNASYN IMIV IN VARIOUS INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42696 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF UNASYN IMIV IN VARIOUS INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42738 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF UNASYN IMIV IN VARIOUS INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42740 |
Study title: AN OPEN NON-COMPARATIVE STUDY OF UNASYN IMIV IN VARIOUS INFECTIONS |
Active substance: SULBACTAM |
Study summary document link (including results): |
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Document reference: 42758 |
Study title: Open-label, randomized, three-way, cross-over single-center study to Prove the equivalence of a single dose of Creon® 10,000 Minimicrospheres™ and Pancrease by using the 13C-mixed triglyceride breath test in patients with pancreatic exocrine insufficiency due to cystic fibrosis |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-S245-3111.pdf |
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Document reference: 47667 |
Study title: Clinical evaluation of TOBRADEX Ophthalmic Suspension versus Tobramycin Ophthalmic Solution (TOBREX) (C9192), |
Active substance: TOBRAMYCIN |
Study summary document link (including results): |
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Document reference: 44818 |
Study title: An evaluation of the efficacy and safety of C-14 elixir in pediatric patients with symptomatology requiring an analgesic and/or antipyretic. |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol 0-206.pdf |
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Document reference: 47503 |
Study title: Treatment of the common cold. Supiyaphun P, Kerekhanjananarong V, Saengpanich S, Cutchavaree A. J Med Assoc Thai. 2003 Jun;86 Suppl 2:S362-72.Treatment of the common cold. Supiyaphun P, Kerekhanjananarong V, Saengpanich S, Cutchavaree A. J Med Assoc Thai. 2003 Jun;86 Suppl 2:S362-72. |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
Study summary document link (including results): |
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Document reference: 33640 |
Study title: Steele R.W., Tanaka P.T., Lara R.P., Bass J.W. : Evaluation of sponging and of oral antipyretic therapy to reduce fever. J. Pediatr. 1970Steele R.W., Tanaka P.T., Lara R.P., Bass J.W. : Evaluation of sponging and of oral antipyretic therapy to reduce fever. J. Pediatr. 1970 |
Active substance: PARACETAMOL |
Study summary document link (including results): |
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Document reference: 45751 |
Study title: Shannon, M. W. and Townsend, M. K. The Pediatric Environmental Health Center, Children's Hospital, Harvard Medical School, Boston, MA 02115, USA. Adverse effects of reduced-dose d-penicillamine in children with mild-to-moderate lead poisoning Ann.Pharmacother. 2000;34:15-18. Shannon, M. W. and Townsend, M. K. The Pediatric Environmental Health Center, Children's Hospital, Harvard Medical School, Boston, MA 02115, USA. Adverse effects of reduced-dose d-penicillamine in children with mild-to-moderate lead poisoning Ann.Pharmacother. 2000;34:15-18. |
Active substance: PENICILLAMINE |
Study summary document link (including results): |
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Document reference: 33838 |
Study title: Valutazione dell’effetto antalgico e della tollerabilità di un nuovo dosaggio di paracetamolo sciroppo nelle faringotonsilliti in pediatria. Studio in doppio cieco verso placebo, controllato verso ketoprofene sale di lisina. |
Active substance: PARACETAMOL |
Study summary document link (including results): |
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Document reference: 45774 |
Study title: 4. Phase 3, randomized, double-blind, PBO-controlled, parallel group, multicenter, dose-response study to evaluate the efficacy and safety of TPM vs. PBO in migraine prophylaxis (plus OL Ext) |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44837 |
Study title: 5. Phase 3, randomized, double-blind, parallel group, multicenter, PBO- and active-controlled, dose-response study to evaluate the efficacy and safety of 2 doses of TPM vs. PBO and PROP in migraine prophylaxis (plus blinded Ext) |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44838 |
Study title: 6. Phase 3, randomized, double-blind, parallel group, multicenter, PBO- and active-controlled, dose-response study to evaluate the efficacy and safety of 2 doses of TPM vs. PBO and PROP in migraine prophylaxis (plus blinded Ext) |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44839 |
Study title: 9. Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in subjects with Lennox-Gastaut syndrome |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44842 |
Study title: Effects of semprex-D and diphenhydramine on learning in young adults with seasonal allergic rhinitis. Vuurman EF, van Veggel LM, Sanders RL, Muntjewerff ND, O'Hanlon, JF. Ann Allergy Asthma Immunol. 1996 Mar;76(3):247-52. |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE AND TRIPTOLIDINE |
Study summary document link (including results): |
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Document reference: 33725 |
Study title: Treatment of the common cold. Supiyaphun P, Kerekhanjananarong V, Saengpanich S, Cutchavaree A. J Med Assoc Thai. 2003 Jun;86 Suppl 2:S362-72. |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE AND TRIPTOLIDINE |
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Document reference: 33724 |
Study title: A multinational, multicentre, prospective, Zaldiar post marketing surveillance observation to assess the safety of Zaldiar (tramadol/paracetamol 37.5 mg/325 mg) and patient satisfaction in the routine Latin American clinical setting |
Active substance: PARACETAMOL AND TRAMADOL |
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Document reference: 44977 |
Study title: Evaluation of the efficacy and safety of tramadol with acetaminophen (RWJ-26898-002-AQ-22) in oral surgical pain |
Active substance: PARACETAMOL AND TRAMADOL |
Study summary document link (including results): paracetamol TRAMAP-ANAG-002.pdf |
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Document reference: 47519 |
Study title: Evaluation of the efficacy and safety of tramadol with acetaminophen (RWJ-26898-002-AQ-22) in oral surgical pain |
Active substance: PARACETAMOL AND TRAMADOL |
Study summary document link (including results): paracetamol TRAMAP-ANAG-003.pdf |
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Document reference: 47520 |
Study title: Evaluation of the efficacy and safety of tramadol/apap in oral surgical pain |
Active substance: PARACETAMOL AND TRAMADOL |
Study summary document link (including results): paracetamol TRAMAP-ANAG-010.pdf |
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Document reference: 47521 |
Study title: Van Esch, Van Steensel-Moll, Steyerberg, Offringa, Habbema, Derksen-Lubsen; Arch Pediatr Adolesc Med Van Esch, Van Steensel-Moll, Steyerberg, Offringa, Habbema, Derksen-Lubsen; Arch Pediatr Adolesc Med |
Active substance: PARACETAMOL |
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Document reference: 45758 |
Study title: Publication in Expert Report - Critical Evaluation - Banerji DD - 06/12/1999 An evaluation of the effects of beclomethasone dipropionate aqueous nasal spray on long-term groqth in children - Rachelefsky GS - 1998 (J. Allergy Clin. Immunol. 101: S236) |
Active substance: TRIAMCINOLONE |
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Document reference: 46834 |
Study title: Publication in Rapport d'Expert sur la documentation pharmaco-toxicologique - Roquet F - 15/08/1995 A thirty day comparison of the oral toxicity of CL 30,980 : 1,4-Pregnadiene-3,20-dione, 9a-fluoro-11b-hydroxy-16a,17a-(isopropylidenedioxy)-21-(tetrahydropyran-2-yloxy)- and CL 22,353 : 1,4-Pregnadiene-3,20-dione, 9a-fluoro-11b,21-dihydroxy-16a,17a-(isopropylidenedioxy)- in rats - Kanegis LA - 26/09/1960 (Safety Evaluation.studies. PR Volume 6, 2694-2726) |
Active substance: TRIAMCINOLONE |
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Document reference: 46838 |
Study title: Publication in Response Document of MRP type II variation - Banerji D - 16/05/2000 A long-term (1 year) safety study of triamcinolone acetonide (TAA) HFA oral inhaler in asthmatic children - Weinberg EG - 1999 (European Respiratory Journal 14 (S30) abstract P361, p42s) |
Active substance: TRIAMCINOLONE |
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Document reference: 46839 |
Study title: Report in Expert Report - Critical Evaluation - Banerji DD - 06/12/1999 A phase III, single center, randomised, cross-over paediatric trial with Nasacort AQ nasal spray assessing short term growth in patients with allergic rhinitis - Kane R- 15/08/2007 |
Active substance: TRIAMCINOLONE |
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Document reference: 46840 |
Study title: Side-effects of oral or intravesical oxybutynin chloride in children with spina bifida - Ferrara P, D'Aleo CM, Tarquini E, Salvatore S, Salvaggio E - BJU International - 2001; 87:674-677Side-effects of oral or intravesical oxybutynin chloride in children with spina bifida - Ferrara P, D'Aleo CM, Tarquini E, Salvatore S, Salvaggio E - BJU International - 2001; 87:674-677 |
Active substance: OXITRIPTAN |
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Document reference: 32924 |
Study title: Namazova Baranova, Kharit, Tuzankina et al 2010; Results of a multicentre study of pidotimod therapy in the prevention of acute respiratory infections in ailing children.Namazova Baranova, Kharit, Tuzankina et al 2010; Results of a multicentre study of pidotimod therapy in the prevention of acute respiratory infections in ailing children. |
Active substance: PIDOTIMOD |
Study summary document link (including results): Namazova_VSP_2-2010_pidotimod+ENG transl.pdf |
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Document reference: 34071 |
Study title: Rev Alerg Mex. 2005 Jan-Feb;52(1):25-38. Comparative meta-analysis of immunoestimulant agents used in pediatric patients in Mexico. de la Torre González C, Pacheco Ríos A, Escalante Domínguez AJ, del Río Navarro BE.Rev Alerg Mex. 2005 Jan-Feb;52(1):25-38. Comparative meta-analysis of immunoestimulant agents used in pediatric patients in Mexico. de la Torre González C, Pacheco Ríos A, Escalante Domínguez AJ, del Río Navarro BE. |
Active substance: PIDOTIMOD |
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Document reference: 34069 |
Study title: Vargas Correa JB, Espinosa Morales S, Bolanos Ancona JC, Farfan Ale JA. “Pidotimod in recurring respiratory infection in children with allergic rhinitis, asthma, or both conditions.” Publication: Rev Alerg Mex 2002; 49: 27-32, (Polichem Ref. N. 0680).Vargas Correa JB, Espinosa Morales S, Bolanos Ancona JC, Farfan Ale JA. “Pidotimod in recurring respiratory infection in children with allergic rhinitis, asthma, or both conditions.” Publication: Rev Alerg Mex 2002; 49: 27-32, (Polichem Ref. N. 0680). |
Active substance: PIDOTIMOD |
Study summary document link (including results): Vargas Correa_2002_pidotimod.pdf |
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Document reference: 34078 |
Study title: Treatment of Pneumocystis carinii pneumonia in infancy Ivady, G. and Paldy, L. (1976). National Cancer Institute Monograph 43:201-208Treatment of Pneumocystis carinii pneumonia in infancy Ivady, G. and Paldy, L. (1976). National Cancer Institute Monograph 43:201-208 |
Active substance: PENTAMIDINE ISETHIONATE |
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Document reference: 45836 |
Study title: Dose-dependent kinetics for theophylline obersvations among ambulatory asthmatic children Sarrazin J Pediatr 19801 97(5) 825-8 in Annual Report 02Dose-dependent kinetics for theophylline obersvations among ambulatory asthmatic children Sarrazin J Pediatr 19801 97(5) 825-8 in Annual Report 02 |
Active substance: THEOPHYLLINE |
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Document reference: 44722 |
Study title: Tay-Uyboco JS, Kwiatkowski K, Cates DB, Kavanagh L, Rigatto H. Hypoxic airway constriction in infants of very low birth weight recovering from moderate to severe bronchopulmonary dysplasia. J Pediatr. 1989; 115:456–459.Tay-Uyboco JS, Kwiatkowski K, Cates DB, Kavanagh L, Rigatto H. Hypoxic airway constriction in infants of very low birth weight recovering from moderate to severe bronchopulmonary dysplasia. J Pediatr. 1989; 115:456–459. |
Active substance: OXITRIPTAN |
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Document reference: 32948 |
Study title: Essai comparatif en double aveugle évaluant l’efficacité et la tolérance d’une dose de charge de 30 mg/kg de paracétamol versus 15 mg/kg dans la fièvre de l’enfant pesant entre 4 et 26 kg. Essai en double aveugle, comparatif sur deux groupes parallèles, multicentrique, phase III.Publication = Treluyer JM. Et al : Antipyretic efficacy of an initial 30 mg/kg loading dose of acetaminophen versus a 15 mg/kg maintenance dose. |
Active substance: PARACETAMOL |
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Document reference: 45780 |
Study title: An observational study collecting data on the efficacy and tolerability of Elidel® (pimecrolimus) cream 1% in patients with mild or moderate atopic dermatitis after one and six weeks in real life practice. |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CSA02 Art45 listing 2011.xls |
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Document reference: 34117 |
Study title: EFFECTIVE ELI – Evaluation of EFFECTIVEness of ELIdel in prevention of flares |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CSI01 Art45 listing 2011.xls |
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Document reference: 34118 |
Study title: A 12 month open label non-controlled extension to a randomized multicenter, parallel-group, double-blind, vehicle controlled study to evaluate the efficacy and safety of 1% SDZ ASM981 cream in the long-term management of atopic dermatitis in children from 3 months to 23 months |
Active substance: PIMECROLIMUS |
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Document reference: 34129 |
Study title: Side-effects of oral or intravesical oxybutynin chloride in children with spina bifida - Ferrara P, D'Aleo CM, Tarquini E, Salvatore S, Salvaggio E - BJU International - 2001; 87:674-677 Side-effects of oral or intravesical oxybutynin chloride in children with spina bifida - Ferrara P, D'Aleo CM, Tarquini E, Salvatore S, Salvaggio E - BJU International - 2001; 87:674-677 |
Active substance: OXYBUTYNIN |
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Document reference: 32997 |
Study title: 16.) Evaluation of effectivness of Wobenzym Therapy in children with recurrent obstructive bronchitis |
Active substance: Pancreatin Papain (HERB) Rutosid • 3 H2O Bromelain (HERB) Trypsin Chymotrypsin Amylase Lipase |
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Document reference: 40106 |
Study title: Essai comparative en double aveugle évaluant l’efficacité et la tolérance d’une dose de charge 30 mg/kg de paracétamol versus 15 mg/kg dans la fièvre de l’entant pesant entre 4 et 26 kg |
Active substance: PARACETAMOL |
Study summary document link (including results): DO 428.pdf |
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Document reference: 47080 |
Study title: Etude multicentrique, ouverte, non comparative, de l'acceptabilite et de la tolerance du paracetamol suspension buvable pediatrique a 4,8% - J. Lalau Keraky, C. Leblond-Joly, V. Dubourg, M. Kabir-Ahmadi, C. Kempf - May 25th, 2007. |
Active substance: PARACETAMOL |
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Document reference: 45779 |
Study title: Evaluation of the efficacy and safety of tramadol/apap in oral surgical pain |
Active substance: PARACETAMOL AND TRAMADOL |
Study summary document link (including results): paracetamol TRAMAP-ANAG-012.pdf |
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Document reference: 47522 |
Study title: Evaluation of the efficacy and safety of tramadol/apap in oral surgical pain |
Active substance: PARACETAMOL AND TRAMADOL |
Study summary document link (including results): paracetamol TRAMAP-ANAG-013.pdf |
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Document reference: 47523 |
Study title: Evaluation of the multiple-dose steady-state pharmacokinetic profile of oral tramadol hydrochloride in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-007; Phase 2) |
Active substance: PARACETAMOL AND TRAMADOL |
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Document reference: 45808 |
Study title: Evaluation of the safety profile and clinical effectiveness of oral tramadol hydrochloride tablets for the treatment of postsurgical pain in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-005; Phase 2) |
Active substance: PARACETAMOL AND TRAMADOL |
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Document reference: 45806 |
Study title: Evaluation of the safety profile of oral tramadol for the treatment of painful conditions in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-008; Phase 2) |
Active substance: PARACETAMOL AND TRAMADOL |
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Document reference: 45809 |
Study title: Open-label evaluation of the pharmacokinetic profile of oral tramadol hydrochloride tablets in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-001 and TRAM-PEDS-006; Phase 2) |
Active substance: PARACETAMOL AND TRAMADOL |
Study summary document link (including results): |
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Document reference: 45805 |
Study title: ELPASO-Elidel Patient Self-observation |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CDE11 Art45 listing 2011.xls |
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Document reference: 34096 |
Study title: An observation post-marketing surveillance (PMS) study evaluating efficacy and safety of Elidel (pimecrolimus) cream 1% in patients >=3 months of age with mild to moderate dermatitis. |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981CPH01 Art45 listing 2011.xls |
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Document reference: 34100 |
Study title: A Phase II, Randomized, Double-Blind, Two-Period, Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palivizumab (MEDI-493, Synagis®), a Humanized Respiratory Syncytial Virus Monoclonal Antibody, in Children with a History of Prematurity |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-mi-cp097.pdf |
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Document reference: 48106 |
Study title: The effect of oxyphenonium bromide and oxybutynin hydrochloride on detrusor contractility and reflux in children with vesicoureteral reflux and detrusor instability. - Scholtmeijer RJ, Van Mastrigt R - J Urol - 1991; 146(2):660-662 The effect of oxyphenonium bromide and oxybutynin hydrochloride on detrusor contractility and reflux in children with vesicoureteral reflux and detrusor instability. - Scholtmeijer RJ, Van Mastrigt R - J Urol - 1991; 146(2):660-662 |
Active substance: OXYBUTYNIN |
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Document reference: 32998 |
Study title: Multi-center, double-blind, randomised, dose ranging study, in pediatric patients 5 to ≤ 16 years of age receiving morphine as standard supplementary pain medication to evaluate pharmacokinetics, efficacy and safety of oxy pediatric liquid (1 mg/ml) versus placebo in the treatment of acute moderate to severe pain. (USA & EU) |
Active substance: OXYCODONE |
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Document reference: 45394 |
Study title: An evaluation of the efficacy and safety of C-14 elixir in pediatric patients with symptomatology requiring an analgesic and/or antipyretic. Jun 1981.An evaluation of the efficacy and safety of C-14 elixir in pediatric patients with symptomatology requiring an analgesic and/or antipyretic. Jun 1981. |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
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Document reference: 33615 |
Study title: Bowe JC, Cornish EJ,Dawson M. Evaluation of folic acid supplements in children taking phenytoin. Dev Med Child Neurol. 1971 Jun;13(3):343-54.Bowe JC, Cornish EJ,Dawson M. Evaluation of folic acid supplements in children taking phenytoin. Dev Med Child Neurol. 1971 Jun;13(3):343-54. |
Active substance: PHENYLEPHRINE |
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Document reference: 33940 |
Study title: de Wolff FA, Peters AC, van Kempen GM. Serum concentrations and enzyme induction in epileptic children treated with phenytoin and valproate. Neuropediatrics. 1982 Feb;13(1):10-3.de Wolff FA, Peters AC, van Kempen GM. Serum concentrations and enzyme induction in epileptic children treated with phenytoin and valproate. Neuropediatrics. 1982 Feb;13(1):10-3. |
Active substance: PHENYLEPHRINE |
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Document reference: 33933 |
Study title: Open label safety evaluation of specific immunotherapy in subjects aged 5-17 years suffering from seasonal allergic rhinoconjunctivitis due to grass pollen not responding to pharmacotherapy |
Active substance: PHLEUM PRATENSE |
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Document reference: 34027 |
Study title: Open label safety evaluation of specific immunotherapy in subjects aged 5-17 years suffering from seasonal allergic rhinoconjunctivitis due to grass pollen not responding to pharmacotherapy |
Active substance: Phleum pratense |
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Document reference: 40125 |
Study title: A Phase III/IV Multicenter Evaluation ofthe Immunogenicity ofPalivizumab (Synagis®) in Children who Previously Received Palivizumab (Synagis®) Prophylaxis and Children Receiving the Drug for the First Time |
Active substance: palivizumab |
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Document reference: 47445 |
Study title: An evaluation of the efficacy and safety of C-14 elixir in pediatric patients with symptomatology requiring an analgesic and/or antipyretic. Jun 1981.An evaluation of the efficacy and safety of C-14 elixir in pediatric patients with symptomatology requiring an analgesic and/or antipyretic. Jun 1981. |
Active substance: PARACETAMOL AND CHLORPHENAMINE AND ASCORBIC ACID |
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Document reference: 33341 |
Study title: Report on ibuprofen in thetretament of juvenile rheumatoid arthritis - initial observation by Dr G Husby ( Norway ) |
Active substance: IBUPROFEN |
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Document reference: 29442 |
Study title: |
Active substance: Inactivated hepatitis A virus |
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Document reference: 47326 |
Study title: Loughnan PM, Greenwald A et al. Pharmacokinetic observations of phenytoin disposition in the newborn and young infant. Archives of Disease in Childhood, 1977, 52: 302-209Loughnan PM, Greenwald A et al. Pharmacokinetic observations of phenytoin disposition in the newborn and young infant. Archives of Disease in Childhood, 1977, 52: 302-209 |
Active substance: PHENYLEPHRINE |
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Document reference: 33937 |
Study title: "The value of whole-bone preparations in pediatrics", Dupuis C., Mouvement thérapeutique, 1966, 11(4):137-139"The value of whole-bone preparations in pediatrics", Dupuis C., Mouvement thérapeutique, 1966, 11(4):137-139 |
Active substance: OSSEIN HYDROXYAPATITE COMPOUND |
Study summary document link (including results): Ossopan nr3..xls |
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Document reference: 47716 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Osteoheel S (tablets) [AWB-AT] |
Active substance: Osteoheel |
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Document reference: 40090 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Ovarium compositum (ampoules) [AWB-AT] |
Active substance: Ovarium compositum |
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Document reference: 40091 |
Study title: Clinical evaluation in pediatrics |
Active substance: PHOLCODINE |
Study summary document link (including results): Pholcodine_STUDY_640.6.002_Lafargues.xls |
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Document reference: 34033 |
Study title: Clinical evaluation in pediatrics. |
Active substance: PHOLCODINE |
Study summary document link (including results): Pholcodine_STUDY__640.6.005_Polonovski.xls |
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Document reference: 34035 |
Study title: Radu H, Keresztes L, Stenzel K. Effects of administration of phosphocreatine on the clinical, biochemical and electromyographic evolution of Duchenne's progressive muscular dystrophy. Minerva Med. 1968; 59 (99): 5524-29 |
Active substance: PHOSPHOCREATINE |
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Document reference: 34038 |
Study title: Simonazzi-P, Tedeschi-C, Lombardi-F, Camurri-G-B. Valutazione isocinetica dell'efficacia della creatina fosfato nel trattamento dell'ipotrofia muscolare da non uso. Il ruolo di farmaci nella medicina riabilitativa 1992; Vol. 2: 262-265 |
Active substance: PHOSPHOCREATINE |
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Document reference: 34036 |
Study title: The effect of oxyphenonium bromide and oxybutynin hydrochloride on detrusor contractility and reflux in children with vesicoureteral reflux and detrusor instability. - Scholtmeijer RJ, Van Mastrigt R - J Urol - 1991; 146(2):660-662The effect of oxyphenonium bromide and oxybutynin hydrochloride on detrusor contractility and reflux in children with vesicoureteral reflux and detrusor instability. - Scholtmeijer RJ, Van Mastrigt R - J Urol - 1991; 146(2):660-662 |
Active substance: OXITRIPTAN |
Study summary document link (including results): |
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Document reference: 32926 |
Study title: Phase IV study to evaluate the safety and efficacy of Phenobarbitone in children |
Active substance: PHENOBARBITAL |
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Document reference: 45871 |
Study title: Evaluer l'acceptabilité et la tolérance clinique de la nouvelle formule d'Oracilline suspension buvable, dosée à 250.000 Unités par cuillère-doseuse de 5 ml, auprès d'une population de nourrissons et de jeunes enfants - Pr Y. Castel, Dr Y. Fryda - 1985 à 1986 (résumé du compte-rendu d'essai clinique)Evaluer l'acceptabilité et la tolérance clinique de la nouvelle formule d'Oracilline suspension buvable, dosée à 250.000 Unités par cuillère-doseuse de 5 ml, auprès d'une population de nourrissons et de jeunes enfants - Pr Y. Castel, Dr Y. Fryda - 1985 à 1986 (résumé du compte-rendu d'essai clinique) |
Active substance: PHENOXYMETHYLPENICILLIN |
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Document reference: 45877 |
Study title: Evaluer l'acceptabilité et la tolérance clinique de la nouvelle formule d'Oracilline suspension buvable, dosée à 250.000 Unités par cuillère-doseuse de 5 ml, auprès d'une population de nourrissons et de jeunes enfants - Pr Y. Castel, Dr Y. Fryda - 1985 à 1986 (résumé du compte-rendu d'essai clinique)Evaluer l'acceptabilité et la tolérance clinique de la nouvelle formule d'Oracilline suspension buvable, dosée à 250.000 Unités par cuillère-doseuse de 5 ml, auprès d'une population de nourrissons et de jeunes enfants - Pr Y. Castel, Dr Y. Fryda - 1985 à 1986 (résumé du compte-rendu d'essai clinique) |
Active substance: PHENOXYMETHYLPENICILLIN |
Study summary document link (including results): |
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Document reference: 45889 |
Study title: Drug surveillance on oxatomide in the treatment of various allergic disorders in specialist center (in Italian) |
Active substance: OXATOMIDE |
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Document reference: 45383 |
Study title: Interim statistical analysis of the study of the bioavailability and antipyretic effectiveness of acetaminophen in children. |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol 102.pdf |
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Document reference: 47515 |
Study title: A comparison of oral ondansetron syrup or intravenous ondansetron loading dose regimens given in combination with dexamethasone for the prevention of nausea and emesis in pediatric and adolescent patients receiving moderately/highly emetogenic chemotherapy. White L, Daly SA, McKenna CJ, Zhestkova N, Leal C, Breatnach F, Smelhaus V, Hung IJ, Kowalczyk J, Ninane J, Mitchell T, Haigh C. Pediatr Hematol Oncol. 2000 Sep; 17(6):445-55.A comparison of oral ondansetron syrup or intravenous ondansetron loading dose regimens given in combination with dexamethasone for the prevention of nausea and emesis in pediatric and adolescent patients receiving moderately/highly emetogenic chemotherapy. White L, Daly SA, McKenna CJ, Zhestkova N, Leal C, Breatnach F, Smelhaus V, Hung IJ, Kowalczyk J, Ninane J... |
Active substance: ONDASETRON |
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Document reference: 32804 |
Study title: Assessment of chemotherapy-induced emesis and evaluation of a reduced-dose intravenous ondansetron regimen in pediatric outpatients with leukemia.Holdsworth MT, Raisch DW, Duncan MH, Chavez CM, Leasure MM.Ann Pharmacother. 1995 Jan; 29(1):16-21. Assessment of chemotherapy-induced emesis and evaluation of a reduced-dose intravenous ondansetron regimen in pediatric outpatients with leukemia.Holdsworth MT, Raisch DW, Duncan MH, Chavez CM, Leasure MM.Ann Pharmacother. 1995 Jan; 29(1):16-21. |
Active substance: ONDASETRON |
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Document reference: 32807 |
Study title: Fusidic acid in infections of the external eye.Bijsterveld O.P. van 1987, Infection, 15: 16-19 |
Active substance: FUSIDIC ACID |
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Document reference: 48457 |
Study title: Clinical and spirometric evaluation of ipratropium bromide and salbutamol in children with bronchitis and preceding asthma. |
Active substance: IPRATROPIUM |
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Document reference: 30548 |
Study title: J Am Acad Dermatol. 1981 Dec;5(6):670-2. A new noninvasive evaluation of muscular lesions in dermatomyositis: thallium 201 muscle scans. Guillet GY, Guillet JA, Blanquet P, Maleville J. J Am Acad Dermatol. 1981 Dec;5(6):670-2. A new noninvasive evaluation of muscular lesions in dermatomyositis: thallium 201 muscle scans. Guillet GY, Guillet JA, Blanquet P, Maleville J. |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44587 |
Study title: A Randomized, Multicenter, 10-Week, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Evaluate the Efficacy and Safety of Paroxetine in Children and Adolescents with Obsessive-Compulsive Disorder (OCD) |
Active substance: PAROXETINE |
Study summary document link (including results): Paroxetine-29060-704-fullCSR.pdf |
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Document reference: 48344 |
Study title: A Randomized, Multicenter, 8-Week, Double-blind, Placebo-Controlled Flexible-Dose Study to Evaluate the Efficacy and Safety of Paroxetine in Children and Adolescents with Major Depressive Disorder |
Active substance: PAROXETINE |
Study summary document link (including results): Paroxetine-29060-701-fullCSR.pdf |
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Document reference: 48343 |
Study title: Effectiveness of Mass Oral Cholera Vaccination in Beira, Mozambique, published in New England Journal Med in Feb 2005 |
Active substance: oral cholera vaccine |
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Document reference: 41502 |
Study title: A phase II, randomised, double-blind, placebo-controlled study to evaluate the immunogenicity, reactogenicity and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine when given concomitantly with OPV versus when given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh. |
Active substance: oral live attenuated human rotavirus |
Study summary document link (including results): |
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Document reference: 45712 |
Study title: Evaluation of immunogenicity of IM MED-493 in children who previously received IM MED-493 prophylaxis and children receiving IM MED-493 for the first time |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-mi-cp036.pdf |
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Document reference: 48102 |
Study title: Safety and Efficacy Study of Palivizumab in Children with Congenital Heart Disease (Phase III Clinical Trial) |
Active substance: palivizumab |
Study summary document link (including results): palivizumab-m03-637.pdf |
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Document reference: 48091 |
Study title: J Am Coll Cardiol. 1983 Mar;1(3):797-803. Variability in coronary hemodynamics in response to ergonovine in patients with normal coronary arteries and atypical chest pain. Schwartz AB, Donmichael TA, Botvinick EH, Ishimori T, Parmley WW, Chatterjee K. J Am Coll Cardiol. 1983 Mar;1(3):797-803. Variability in coronary hemodynamics in response to ergonovine in patients with normal coronary arteries and atypical chest pain. Schwartz AB, Donmichael TA, Botvinick EH, Ishimori T, Parmley WW, Chatterjee K. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44588 |
Study title: J Am Coll Cardiol. 1998 Aug;32(2):413-9. Efficacy of augmented immunosuppressive therapy for early vasculopathy in heart transplantation. Lamich R, Ballester M, Martà V, Brossa V, Aymat R, Carrió I, Bernà L, Campreciós M, Puig M, Estorch M, FlotatsJ Am Coll Cardiol. 1998 Aug;32(2):413-9. Efficacy of augmented immunosuppressive therapy for early vasculopathy in heart transplantation. Lamich R, Ballester M, Martà V, Brossa V, Aymat R, Carrió I, Bernà L, Campreciós M, Puig M, Estorch M, Flotats |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44590 |
Study title: J Bone Joint Surg Am. 1993 Apr;75(4):526-31. Comment in: J Bone Joint Surg Am. 1993 Dec;75(12):1880-1. Thallium-201 scanning for the evaluation of osteosarcoma and soft-tissue sarcoma. A study of the evaluation and predictability of the histologicalJ Bone Joint Surg Am. 1993 Apr;75(4):526-31. Comment in: J Bone Joint Surg Am. 1993 Dec;75(12):1880-1. Thallium-201 scanning for the evaluation of osteosarcoma and soft-tissue sarcoma. A study of the evaluation and predictability of the histological |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44592 |
Study title: Zumpft CW. Double-blind comparison of metizoline hydrochloride (Ellsyl) and phenylephrine in allergic and vasomotor rhinitis. Curr Ther Res Clin Exp 1975; 17(1):40-6 Zumpft CW. Double-blind comparison of metizoline hydrochloride (Ellsyl) and phenylephrine in allergic and vasomotor rhinitis. Curr Ther Res Clin Exp 1975; 17(1):40-6 |
Active substance: PHENYLEPHRINE |
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Document reference: 45102 |
Study title: Bavdekar, A. R., Bhave, S. A., Pradhan, A. M., Pandit, A. N., and Tanner, M. S. Department of Paediatrics, King Edward Memorial Hospital, Pune, India Long term survival in Indian childhood cirrhosis treated with D-penicillamine Arch.Dis.Child 1996;74:32-35. Bavdekar, A. R., Bhave, S. A., Pradhan, A. M., Pandit, A. N., and Tanner, M. S. Department of Paediatrics, King Edward Memorial Hospital, Pune, India Long term survival in Indian childhood cirrhosis treated with D-penicillamine Arch.Dis.Child 1996;74:32-35. |
Active substance: PENICILLAMINE |
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Document reference: 33839 |
Study title: A randomised,multicenter comparison of Curosurf and Survanta in the treatment of established neonatal rerspiratory distress syndrome |
Active substance: PHOSPHOLIPIDS |
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Document reference: 34043 |
Study title: Vashev EA. Some aspects of virus hepatitis B treatment in children. Mikrobiol epidemiol i klinika infeksionnykh boleznei 1988, 46-8 (currently only summary available) Vashev EA. Some aspects of virus hepatitis B treatment in children. Mikrobiol epidemiol i klinika infeksionnykh boleznei 1988, 46-8 (currently only summary available) |
Active substance: PHOSPHOLIPIDS AND VITAMINS |
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Document reference: 34045 |
Study title: 13C02 breath test with 13C-labelled hiolein for the non-invasive determination of exocrine pancreatic function in healthy subjects and in patients with cystiC fibrosis: Efficacy assessment of pancreatic enzyme replacement in children with cystic fibrosis |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-KREO-629.pdf |
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Document reference: 47658 |
Study title: A prospectively randomized, cross-over study to evaluate the acceptability of Creon® granules in sachets with Creon® 8000 capsules in the treatment of pancreatic insufficiency in cystic fibrosis patients |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-KREO-592.pdf |
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Document reference: 47657 |
Study title: Goyal−P−K et al. Double blind randomized comparative evaluation of nimesulide and paracetamol as antipyretics. {Indian−Pediatr}, Jun 1998, vol. 35, no. 6, p. 519−22Goyal−P−K et al. Double blind randomized comparative evaluation of nimesulide and paracetamol as antipyretics. {Indian−Pediatr}, Jun 1998, vol. 35, no. 6, p. 519−22 |
Active substance: PARACETAMOL AND DIPHENHYDRAMINE |
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Document reference: 33385 |
Study title: Rev Esp Cardiol. 1983;36(3):239-46. [Thallium-201 in newborn infants and children with myocardial pathology] [Article in Spanish] Cazzaniga M, Casanova M, Castro Beiras J, MartÃn Curto M, Crespo A, Ramos A, Vázquez R. Rev Esp Cardiol. 1983;36(3):239-46. [Thallium-201 in newborn infants and children with myocardial pathology] [Article in Spanish] Cazzaniga M, Casanova M, Castro Beiras J, MartÃn Curto M, Crespo A, Ramos A, Vázquez R. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44697 |
Study title: |
Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE |
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Document reference: 33952 |
Study title: Bioavailability and efficacy of Konakion MM ampoules vs Konakion drops in healthy newborn at term (>2000g) breastfed infants 2mg per os |
Active substance: PHYTOMENADION |
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Document reference: 34061 |
Study title: Bioavailability and efficacy of Konakion MM Ro 01-6722/130, 1.5mg vitamin K1 i.m. versus 3.0mg vitamin K1 oral in healthy newborn breast-fed babies |
Active substance: PHYTOMENADION |
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Document reference: 34058 |
Study title: Bioavailability of Konakino MM, Ro 01-6722/130, oral and parenteral in mature neonates at birth (>2000g) and the evolution of vitamin K1 plasma level in breastfed babies |
Active substance: PHYTOMENADION |
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Document reference: 34059 |
Study title: Comparative bioavailability and kinetics of Konakion MM: Ro 01-6722/122, oral and parenteral in infants suffering from chronic cholestasis |
Active substance: PHYTOMENADION |
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Document reference: 34057 |
Study title: Evaluation of the interaction potential of Mixed micelles with the binding to albumin |
Active substance: PHYTOMENADION |
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Document reference: 34056 |
Study title: A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. Jan 1988.A comparative dose range evaluation of the antipyretic efficacy and safety of ibuprofen liquid at three different doses in children. Jan 1988. |
Active substance: PARACETAMOL AND PHENYLEPHRINE |
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Document reference: 33605 |
Study title: Pharmacologic evaluation of orally administered antibiotics in infants and children: effect of feeding on bioavailability - Mc Cracken G. H, Jr, Ginsburb Ch. M., Clahsen J.C. & Thomas M. L. - 1978 (Pediatrics, 62 (5) 738 - 743, 10 réf.)Pharmacologic evaluation of orally administered antibiotics in infants and children: effect of feeding on bioavailability - Mc Cracken G. H, Jr, Ginsburb Ch. M., Clahsen J.C. & Thomas M. L. - 1978 (Pediatrics, 62 (5) 738 - 743, 10 réf.) |
Active substance: PHENOXYMETHYLPENICILLIN |
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Document reference: 45881 |
Study title: Rev Esp Med Nucl. 2004 Sep-Oct;23(5):330-7. [Value of thallium 201-SPECT in typing brain space-occupying lesions] [Article in Spanish] MartÃnez del Valle Torres MD, Gómez Rio M, RodrÃguez Fernández A, Sabatel Hernandez G, Ortega Lozano S, Ramos FonRev Esp Med Nucl. 2004 Sep-Oct;23(5):330-7. [Value of thallium 201-SPECT in typing brain space-occupying lesions] [Article in Spanish] MartÃnez del Valle Torres MD, Gómez Rio M, RodrÃguez Fernández A, Sabatel Hernandez G, Ortega Lozano S, Ramos Fon |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44700 |
Study title: Rinsho Hoshasen. 1990 Feb;35(2):253-7. [The role and clinical value of thallium-201 myocardial scintigraphy in ischemic heart disease] [Article in Japanese] Shimada T, Nakamori H, Kurimoto T, Karakawa M, Matsuura T, Iwasaka T, Inada M, Nishiyama Y. Rinsho Hoshasen. 1990 Feb;35(2):253-7. [The role and clinical value of thallium-201 myocardial scintigraphy in ischemic heart disease] [Article in Japanese] Shimada T, Nakamori H, Kurimoto T, Karakawa M, Matsuura T, Iwasaka T, Inada M, Nishiyama Y. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44701 |
Study title: Semin Nucl Med. 1980 Jan;10(1):16-26. Detection and quantitation of cardiovascular shunts with commonly available radionuclides. Treves S. Semin Nucl Med. 1980 Jan;10(1):16-26. Detection and quantitation of cardiovascular shunts with commonly available radionuclides. Treves S. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44702 |
Study title: A Double-Blind Study of PARAFON FORTE, Acetaminophen, PARAFLEX, and Placebo in Outpatients Following Surgical Removal of Impacted Third Molars. Protocol ASD, Unpublished Report SR-199-02. |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol ASD.pdf |
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Document reference: 47516 |
Study title: A phase III randomized multi-center study to assess the immunogenicity of three doses of Pediarix®, Prevnar® and ActHIB® given to healthy infants at 2, 4 and 6 months of age when administered with GlaxoSmithKline (GSK) Biologicals’ two-dose oral live attenuated human rotavirus (HRV) vaccine given during the same vaccination visit (at 2 and 4 months of age) or given separately (at 3 and 5 months of age). |
Active substance: oral live attenuated human rotavirus |
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Document reference: 45713 |
Study title: A phase IIIb, double-blind, randomized, placebo-controlled, multicentre study to assess the immunogenicity, safety and reactogenicity of 2 doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants (6-12 weeks of age at first dose) previously uninfected with human rotavirus. |
Active substance: oral live attenuated human rotavirus |
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Document reference: 45710 |
Study title: A phase IIIb, randomised, multicentre double-blind, placebo-controlled study of the immunogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine (RIX4414) as primary dosing in healthy infants in India of approximately 8 weeks of age at the first dose. |
Active substance: oral live attenuated human rotavirus |
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Document reference: 45711 |
Study title: Tizanidine treatment of spasticity: a meta−analysis of controlled, double−blind, comparative studies with baclofen and diazepam.Groves L, Shellenberger MK, Davis CS. Advances in therapy, Jul−Aug 1998, vol. 15, no. 4, p. 241−51.Tizanidine treatment of spasticity: a meta−analysis of controlled, double−blind, comparative studies with baclofen and diazepam.Groves L, Shellenberger MK, Davis CS. Advances in therapy, Jul−Aug 1998, vol. 15, no. 4, p. 241−51. |
Active substance: TIZANIDINE |
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Document reference: 38512 |
Study title: A double-blind, single dose evaluation comparing the analgesic efficacy and adverse effect liability of acetaminophen 650 mg, acetaminophen 1000 mg and placebo in the treatment of postoperative pain following oral surgery. |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol 0-223.pdf |
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Document reference: 47505 |
Study title: A double-blind, single dose evaluation of the relative analgesia and safety of acetaminophen 2000 mg, 1500 mg, 1000 mg, 500 mg, and placebo in the treatment of pain following oral or periodontal surgery. |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol 1-221.pdf |
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Document reference: 47507 |
Study title: A double-dose, single dose evaluation comparing the analgesic efficacy and adverse effect liability of acetaminophen 650 mg, acetaminophen 1000 mg and placebo in the treatment of postoperative pain following oral surgery. |
Active substance: PARACETAMOL |
Study summary document link (including results): paracetamol 0-214.pdf |
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Document reference: 47504 |
Study title: Bacteriology and treatment of purulent nasopharyngitis: a double blind, placebo-controlled evaluation. Todd JK, Todd N, Damato J, Todd WA. Pediatr Infect Dis. 1984 May-Jun;3(3):226-32.Bacteriology and treatment of purulent nasopharyngitis: a double blind, placebo-controlled evaluation. Todd JK, Todd N, Damato J, Todd WA. Pediatr Infect Dis. 1984 May-Jun;3(3):226-32. |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
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Document reference: 33643 |
Study title: Clinical Trial of High Lipase Pancreatic Enzyme Supplementation in Cystic Fibrosis: Evaluation of Creon® 25 000 |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-K224-5006.pdf |
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Document reference: 47654 |
Study title: Double-blind, multicenter, randomized, crossover study to prove equivalent efficacy of Creon® 10 000 minimicrospheresTM and Creon® 8 000 microspheres in patients with pancreatic exocrine insufficiency caused by cystic fibrosis |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-K245-5004.pdf |
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Document reference: 45110 |
Study title: 3. Evaluation of the optimal dose of topiramate in epilepsy monotherapy. |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44937 |
Study title: 31. Prospective evaluation of epilepsy treatment with topiramate. |
Active substance: TOPIRAMATE |
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Document reference: 44965 |
Study title: 32. Safety and Efficacy of Topamax in Monotherapy or Combined Therapy in Children & Adult Patients with Epilepsy, in an Observational Study with Medium Duration of 8 Months. |
Active substance: TOPIRAMATE |
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Document reference: 44966 |
Study title: Effects of semprex-D and diphenhydramine on learning in young adults with seasonal allergic rhinitis. Vuurman EF, van Veggel LM, Sanders RL, Muntjewerff ND, O'Hanlon, JF. Ann Allergy Asthma Immunol. 1996 Mar;76(3):247-52.Effects of semprex-D and diphenhydramine on learning in young adults with seasonal allergic rhinitis. Vuurman EF, van Veggel LM, Sanders RL, Muntjewerff ND, O'Hanlon, JF. Ann Allergy Asthma Immunol. 1996 Mar;76(3):247-52. |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
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Document reference: 33641 |
Study title: Efficacy of acrivastine plus pseudoephedrine for symptomatic relief of seasonal allergic rhinitis due to mountain cedar. Ann Allergy Asthma Immunol 1996; 76(5):432-438Efficacy of acrivastine plus pseudoephedrine for symptomatic relief of seasonal allergic rhinitis due to mountain cedar. Ann Allergy Asthma Immunol 1996; 76(5):432-438 |
Active substance: PARACETAMOL AND PSEUDOEPHEDRINE |
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Document reference: 33637 |
Study title: Breitwieser et al.Conservative treatment of uric acid sone diathesis; Med. Welt 1967, 8: 2130-2135Breitwieser et al.Conservative treatment of uric acid sone diathesis; Med. Welt 1967, 8: 2130-2135 |
Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE |
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Document reference: 33964 |
Study title: Careddu et al. Treatment of lower Urinary Tract infections in Children: single Dose Fosfomycin Trometamol Versus Pipemidic Acid. Chemioterapia, 6 pp 290-294, 1987 Careddu et al. Treatment of lower Urinary Tract infections in Children: single Dose Fosfomycin Trometamol Versus Pipemidic Acid. Chemioterapia, 6 pp 290-294, 1987 |
Active substance: PHENYLEPHRINE AND PREDNISOLONE_PHENYEPHRINE ANDZINC SULPHATE |
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Document reference: 33961 |
Study title: Lakatos, L., Hatvani, I., Oroszlan, G., Balla, G., Karmazsin, L., Alaka, O., Kincses, E., Szabo, I., and Lakatos, Z. Controlled trial of D-penicillamine to prevent retinopathy of prematurity Acta Paediatr.Hung. 1986;27:47-56. Lakatos, L., Hatvani, I., Oroszlan, G., Balla, G., Karmazsin, L., Alaka, O., Kincses, E., Szabo, I., and Lakatos, Z. Controlled trial of D-penicillamine to prevent retinopathy of prematurity Acta Paediatr.Hung. 1986;27:47-56. |
Active substance: PENICILLAMINE |
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Document reference: 33843 |
Study title: Prieur, A. M., Piussan, C., Manigne, P., Bordigoni, P., and Griscelli, C. Evaluation of D-penicillamine in juvenile chronic arthritis. A double-blind, multicenter study Arthritis Rheum. 1985;28:376-382. Prieur, A. M., Piussan, C., Manigne, P., Bordigoni, P., and Griscelli, C. Evaluation of D-penicillamine in juvenile chronic arthritis. A double-blind, multicenter study Arthritis Rheum. 1985;28:376-382. |
Active substance: PENICILLAMINE |
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Document reference: 33844 |
Study title: Final Study Report: Bioavailability of three Vitamin K1 preparations (cremophore /119, mixed micelles /131, mixed micelles /141) relative to Tween 80/143 formulation (M10400/BK14677) |
Active substance: PHYTOMENADION |
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Document reference: 34049 |
Study title: Double~blind, bicenter, randomized, crossover study to prove equivalent efficacy and tolerance of Creon® 25 000 Minimicrospheres™ versus Creon® 25 000 Microspheres (Pankreon® forte) in patients with pancreatic exocrine insufficiency caused by cystic fibrosis. |
Active substance: Pancreatin |
Study summary document link (including results): Pancreatin-S248-3002.pdf |
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Document reference: 47672 |
Study title: A randomized, double-blind, parallel group, placebo-controlled, four-week efficacy and safety evaluation of Nasacort AQ 110 μg QD, followed by six-month open-label safety in children ages 2-5 years with perennial allergic rhinitis |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): Triamcinolone Acetonide-Study 1.pdf |
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Document reference: 46825 |
Study title: An Open-Label, Repeat Dose, Multicenter Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Intranasally Administered Triamcinolone Acetonide (Nasacort AQ) in Pediatric Allergic Rhinitis Patients 2 to 5 Years of Age Compared to Adult Patients 18 to 50 Years of Age |
Active substance: TRIAMCINOLONE |
Study summary document link (including results): Triamcinolone Acetonide-Study 2.pdf |
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Document reference: 46830 |
Study title: Controlled clinical study comparing the efficacy of twice daily applications of westcort (hydrocortisone valerate) cream 0,2% and Kenalog (triamcinolonacetonide) cream 0,1% in the treatment of children with atopic dermatitis. |
Active substance: TRIAMCINOLONE |
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Document reference: 46820 |
Study title: Graf et al. Ten days' Use of Oxymetazoline Nasal Spray With or Without Benzalkonium Chloride in Patients With Vasomotor Rhinits. Arch Otolaryngol Head Neck Surg 1999; 125: 1128-1132Graf et al. Ten days' Use of Oxymetazoline Nasal Spray With or Without Benzalkonium Chloride in Patients With Vasomotor Rhinits. Arch Otolaryngol Head Neck Surg 1999; 125: 1128-1132 |
Active substance: OXITRIPTAN |
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Document reference: 32960 |
Study title: Randomized comparative trial to evaluate efficacy and tolerability of Konakion MM, Ro 01-6722/135, Konakion drops Ro 01-6722/119 intramuscularly in the prophylaxis of hemorrhagic disease in newbord, breastfed infants |
Active substance: PHYTOMENADION |
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Document reference: 34062 |
Study title: Aivazis V, Hatzimichail A, Papachristou A, Valeri R, Iuga-Donca G. "Clinical evaluation and changes of the respiratory epithelium function after administration of Pidotimod in Greek children with recurrent respiratory tract infections."Publication: Minerva Pediatr 2002; 54: 315-319Aivazis V, Hatzimichail A, Papachristou A, Valeri R, Iuga-Donca G. "Clinical evaluation and changes of the respiratory epithelium function after administration of Pidotimod in Greek children with recurrent respiratory tract infections."Publication: Minerva Pediatr 2002; 54: 315-319 |
Active substance: PIDOTIMOD |
Study summary document link (including results): Aivazis_2002_pidotimod.pdf |
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Document reference: 34077 |
Study title: Arzneimittelforschung. 1994 Dec;44(12A):1506-11. Role of immunoactivation with pidotimod in recurrent respiratory infections in childhood. Careddu P. Arzneimittelforschung. 1994 Dec;44(12A):1506-11. Role of immunoactivation with pidotimod in recurrent respiratory infections in childhood. Careddu P. |
Active substance: PIDOTIMOD |
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Document reference: 34072 |
Study title: Arzneimittelforschung. 1994 Dec;44(12A):1525-9 Immunoactivation by pidotimod in children with recurrent respiratory infections. Burgio GR, Marseglia GL, Severi F, De Benedetti F, Masarone M, Ottolenghi A, Pagliano L, Serra U, Nespoli LArzneimittelforschung. 1994 Dec;44(12A):1525-9 Immunoactivation by pidotimod in children with recurrent respiratory infections. Burgio GR, Marseglia GL, Severi F, De Benedetti F, Masarone M, Ottolenghi A, Pagliano L, Serra U, Nespoli L |
Active substance: PIDOTIMOD |
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Document reference: 34076 |
Study title: DOXERGAN (OXOMEMAZINE)- Tablet 10mg, Syrup 01%.. Summary document. France validation dossier 17/06/1988. Clinical information. Reference to clinical Expert report from LARBRE F., Lyon 12/07/1962. Children 5months-13 years treated from 4 to 21 days. (French language) |
Active substance: OXOMEMAZINE |
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Document reference: 32974 |
Study title: Gazzolo, D., Masetti, P., Kornacka, M., Abella, R., Bruschettini, P., and Michetti, F. Department of Pediatrics, G Gaslini University Hospital, Genoa, Italy. Phentolamine administration increases blood S100B protein levels in pediatric open-heart surgery patients Acta Paediatr. 2003;92:1427-1432.Gazzolo, D., Masetti, P., Kornacka, M., Abella, R., Bruschettini, P., and Michetti, F. Department of Pediatrics, G Gaslini University Hospital, Genoa, Italy. Phentolamine administration increases blood S100B protein levels in pediatric open-heart surgery patients Acta Paediatr. 2003;92:1427-1432. |
Active substance: PHENTOLAMINE |
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Document reference: 33929 |
Study title: Koner, O., Tekin, S., Koner, A., Soybir, N., Seren, S., and Karaoglu, K. Department of Anaesthesiology and Intensive Care, Cardiology Institute of Istanbul University, Turkey Effects of phentolamine on tissue perfusion in pediatric cardiac surgery J.Cardiothorac.Vasc.Anesth. 1999;13:191-197. Koner, O., Tekin, S., Koner, A., Soybir, N., Seren, S., and Karaoglu, K. Department of Anaesthesiology and Intensive Care, Cardiology Institute of Istanbul University, Turkey Effects of phentolamine on tissue perfusion in pediatric cardiac surgery J.Cardiothorac.Vasc.Anesth. 1999;13:191-197. |
Active substance: PHENTOLAMINE |
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Document reference: 33928 |
Study title: Wien Klin Wochenschr. 1988 Dec 16;100(24):792-7. [Value of myocardial scintigraphy of coronary anomaly in the differential diagnosis of pediatric cardiomegaly] [Article in German] Schlemmer M, Pachinger O, Sochor H, Strigl E, Salzer-Muhar U, Wimmer M. Wien Klin Wochenschr. 1988 Dec 16;100(24):792-7. [Value of myocardial scintigraphy of coronary anomaly in the differential diagnosis of pediatric cardiomegaly] [Article in German] Schlemmer M, Pachinger O, Sochor H, Strigl E, Salzer-Muhar U, Wimmer M. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44711 |
Study title: Z Kardiol. 1988 Aug;77(8):503-7. [Disorders of myocardial perfusion in Kawasaki syndrome: noninvasive detection by 201 thallium tomography] [Article in German] Nienaber CA, Hausdorf G, Spielmann RP. Z Kardiol. 1988 Aug;77(8):503-7. [Disorders of myocardial perfusion in Kawasaki syndrome: noninvasive detection by 201 thallium tomography] [Article in German] Nienaber CA, Hausdorf G, Spielmann RP. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44713 |
Study title: Zhonghua Nei Ke Za Zhi. 1985 Dec;24(12):715-8, 767-8. [Clinical evaluation of thallium-201 myocardial imaging] [Article in Chinese] Liu XJ, Shi RF, Guo XZ. Zhonghua Nei Ke Za Zhi. 1985 Dec;24(12):715-8, 767-8. [Clinical evaluation of thallium-201 myocardial imaging] [Article in Chinese] Liu XJ, Shi RF, Guo XZ. |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44714 |
Study title: A Multiclinic Evaluation of the efficacy and safety of Ciprofloxacin Ophthalmic Ointment versus TOBREX Ophthalmic Ointment in treating bacterial conjuncivitis (C8824a). |
Active substance: TOBRAMYCIN |
Study summary document link (including results): |
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Document reference: 44815 |
Study title: Comparative evaluation of intravenous and oral ornidazole vs. clindamycin in acute infections due to anaerobic bacteria. |
Active substance: ORNIDAZOLE |
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Document reference: 45375 |
Study title: Prospective, non-comparative, one center study, evaluating the efficacy and safety of the combination of 2g ceftriaxone plus 1g ornidazole administered as a short intravenous infusion once daily in the treatment of severe chorioamnionitis. |
Active substance: ORNIDAZOLE |
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Document reference: 45374 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (ampoules) [AWB-AT] |
Active substance: Traumeel - Ampullen |
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Document reference: 40284 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (tablets/drops) [AWB-009] |
Active substance: Traumeel - Tropfen |
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Document reference: 40278 |
Study title: Bannikov, Mihail Y.; Vasilenko, Inna V.: Anwendung von homöopathischen Komplexmitteln in der Behandlungakuter kindlicher Speiseröhrenverätzungen. Biol Med 2000 (29):253-254 [IIT-publication] |
Active substance: Traumeel S |
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Document reference: 40270 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (tablets) in children aged up to 11 years old [AWB-090] |
Active substance: Traumeel S |
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Document reference: 40265 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (ointment) in children aged up to 11 years old [AWB-091] |
Active substance: Traumeel S |
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Document reference: 40274 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to the treatment of tendopathy with Traumeel S (ointment) [AWB-146]; |
Active substance: Traumeel S |
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Document reference: 40275 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (tablets/drops) [AWB-009] |
Active substance: Traumeel S |
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Document reference: 40264 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (tablets) [AWB-112]; |
Active substance: Traumeel S |
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Document reference: 40266 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (drops) [AWB-AT]; Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (tablets/drops) [AWB-009]; |
Active substance: Traumeel S |
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Document reference: 40267 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (ampoules) [AWB-AT]; |
Active substance: Traumeel S |
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Document reference: 40272 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (ointment) [AWB-AT] |
Active substance: Traumeel S |
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Document reference: 40273 |
Study title: European Commission Scientific Committee on Food. Opinion of the Scientific Commitee on Food on the tolerable upper intake leval of vitamin B6 (http : // europa.eu.int/comm/food/fs/sc/scf/index en.htlm) - 11/2000 - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -European Commission Scientific Committee on Food. Opinion of the Scientific Commitee on Food on the tolerable upper intake leval of vitamin B6 (http : // europa.eu.int/comm/food/fs/sc/scf/index en.htlm) - 11/2000 - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31487 |
Study title: Extract of submission to the UK's Food Standards Agency - P. Holford et al. - 2003 (Journal of Orthomolecular Medicine vol 18) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31482 |
Study title: High - dose pyridoxine and magnesium administration in children with autistic disorder : an absence of salutary effect in a double-blind, placebo-controlled study - R.L Finding et al. - 1997 (Journal of Autism and Developmental Disorders vol 27) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -High - dose pyridoxine and magnesium administration in children with autistic disorder : an absence of salutary effect in a double-blind, placebo-controlled study - R.L Finding et al. - 1997 (Journal of Autism and Developmental Disorders vol 27) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Eston... |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31488 |
Study title: Institute of Medicine (US). Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Food and Nutrition Board. Dietary Reference Intakes for folate, other B vitamins, and choline. - no author - 1999 (Washington DC : National Academy Press) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Institute of Medicine (US). Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Food and Nutrition Board. Dietary Reference Intakes for folate, other B vitamins, and choline. - no author - 1999 (Washington DC : National Academy Press) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised dur... |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31489 |
Study title: Kaku Igaku. 1983 Dec;20(10):1433-40. [Evaluation of myocardial involvement in Duchenne progressive muscular dystrophy with thallium-201 myocardial perfusion imaging] [Article in Japanese] Kawai N, Yamamoto S, Okada M, Iwase M, Miyakoda H, Yokota M, SoKaku Igaku. 1983 Dec;20(10):1433-40. [Evaluation of myocardial involvement in Duchenne progressive muscular dystrophy with thallium-201 myocardial perfusion imaging] [Article in Japanese] Kawai N, Yamamoto S, Okada M, Iwase M, Miyakoda H, Yokota M, So |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44639 |
Study title: Kaku Igaku. 1983 Mar;20(2):179-91. [Quantitative evaluation of right ventricular overload with thallium-201 myocardial perfusion scintigraphy] [Article in Japanese] Watanabe T, Miyakoda H, Koike Y, Itatsu H, Kawai N, Sotobata I. Kaku Igaku. 1983 Mar;20(2):179-91. [Quantitative evaluation of right ventricular overload with thallium-201 myocardial perfusion scintigraphy] [Article in Japanese] Watanabe T, Miyakoda H, Koike Y, Itatsu H, Kawai N, Sotobata I. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44641 |
Study title: Kaku Igaku. 1985 Sep;22(9):1353-9. [Evaluation of cardiomyopathy in Duchenne muscular dystrophy by Tl-201 myocardial SPECT] [Article in Japanese] Jinnouchi S, Asai J, Inoue K, Hoshi H, Watanabe K. Kaku Igaku. 1985 Sep;22(9):1353-9. [Evaluation of cardiomyopathy in Duchenne muscular dystrophy by Tl-201 myocardial SPECT] [Article in Japanese] Jinnouchi S, Asai J, Inoue K, Hoshi H, Watanabe K. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44642 |
Study title: Nippon Kyobu Geka Gakkai Zasshi. 1989 Jan;37(1):103-9. [Follow-up study of coronary artery bypass grafting after Kawasaki disease--early and late postoperative evaluation] [Article in Japanese] Ohara K, Yagihara T, Kishimoto H, Isobe F, Yamamoto F, NabNippon Kyobu Geka Gakkai Zasshi. 1989 Jan;37(1):103-9. [Follow-up study of coronary artery bypass grafting after Kawasaki disease--early and late postoperative evaluation] [Article in Japanese] Ohara K, Yagihara T, Kishimoto H, Isobe F, Yamamoto F, Nab |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44671 |
Study title: Nippon Naika Gakkai Zasshi. 1986 Sep;75(9):1234-42. [Evaluation of myocardial and skeletal muscular involvement with thallium-201 myocardial emission computed tomography and whole body scintigraphy] [Article in Japanese] Yamamoto S, Matsushima H, SotobNippon Naika Gakkai Zasshi. 1986 Sep;75(9):1234-42. [Evaluation of myocardial and skeletal muscular involvement with thallium-201 myocardial emission computed tomography and whole body scintigraphy] [Article in Japanese] Yamamoto S, Matsushima H, Sotob |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44672 |
Study title: Nucl Med Commun. 2001 Sep;22(9):1015-9. Inhomogeneity of myocardial perfusion in heart transplant recipients: evaluation with dobutamine thallium-201 SPECT. Yen RF, Ho YL, Chou NK, Hsu RB, Huang PJ Nucl Med Commun. 2001 Sep;22(9):1015-9. Inhomogeneity of myocardial perfusion in heart transplant recipients: evaluation with dobutamine thallium-201 SPECT. Yen RF, Ho YL, Chou NK, Hsu RB, Huang PJ |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44676 |
Study title: Bioavailibility of 5-ASA from slow release 5-ASA drug and sulfasalazine in normal children; Christensen LA et al, Dig. Diseases and Sci., 1993, 38(10):1831-6 |
Active substance: MESALAZINE |
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Document reference: 31628 |
Study title: Am Heart J. 1998 Mar;135(3):482-7. Noninvasive evaluation of myocardial ischemia in Kawasaki disease: comparison between dipyridamole stress thallium imaging and exercise stress testing. Fukuda T, Akagi T, Ishibashi M, Inoue O, Sugimura T, Kato H. Am Heart J. 1998 Mar;135(3):482-7. Noninvasive evaluation of myocardial ischemia in Kawasaki disease: comparison between dipyridamole stress thallium imaging and exercise stress testing. Fukuda T, Akagi T, Ishibashi M, Inoue O, Sugimura T, Kato H. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44499 |
Study title: A comparison of single dose caudal tramadol, tramadol plus bupivacaine and bupivacaine administration for postoperative analgesia in children - Gunduz M, Ozengiz D, Ozbek H, Isik G - 2001 (Paediatric Anaesthesia, 2001; 11: 323-326) |
Active substance: TRAMADOL |
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Document reference: 45015 |
Study title: Relevance of tiapride in treatment of certain abnormal movements of the encephalopathic child - Gardisseaux J.F., Maloteaux J.M., Ferriere G. - neuropsych. Enf. Adolesc., 1985, 33, 139-143Relevance of tiapride in treatment of certain abnormal movements of the encephalopathic child - Gardisseaux J.F., Maloteaux J.M., Ferriere G. - neuropsych. Enf. Adolesc., 1985, 33, 139-143 |
Active substance: TIAPRIDE |
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Document reference: 38472 |
Study title: A Phase I open-label single center (historically controlled) study to evaluate the safety, tolerability and immunogenicity using three doses of polygeline free tick-borne encephalitis (TBE) vaccine in children. |
Active substance: Tick-Borne Encephalitis Virus |
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Document reference: 48395 |
Study title: A Phase III multicenter, open label extension study of the safety and immunogenicity of a single booster dose of polygeline-free tick borne encephalitis (TBE) vaccine in children. |
Active substance: Tick-Borne Encephalitis Virus |
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Document reference: 48402 |
Study title: a Phase III multicenter, single-blind, randomized, historically controlled-study of a new polygeline-free TBE vaccine in healthy children ages 1 to 11 years. |
Active substance: Tick-Borne Encephalitis Virus |
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Document reference: 48401 |
Study title: Efficacy of neuroprotectors in patients with tension headaches.Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6Efficacy of neuroprotectors in patients with tension headaches.Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6 |
Active substance: TINZANIDINE |
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Document reference: 44788 |
Study title: Efficacy of neuroprotectors in patients with tension headaches.Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6Efficacy of neuroprotectors in patients with tension headaches.Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6 |
Active substance: TINZANIDINE |
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Document reference: 44800 |
Study title: Evaluation of a muscle relaxant on sequelae of third molar surgery: a pilot study.Kirmeier R, Truschnegg A, Payer M, Acham S, Schulz K, Jakse N. Oral surgery oral medicine oral pathology oral radiology and endodontics, Sep 2007 (epub: 06 Jul 2007), vol. 104, no. 3,p. e8−14Evaluation of a muscle relaxant on sequelae of third molar surgery: a pilot study.Kirmeier R, Truschnegg A, Payer M, Acham S, Schulz K, Jakse N. Oral surgery oral medicine oral pathology oral radiology and endodontics, Sep 2007 (epub: 06 Jul 2007), vol. 104, no. 3,p. e8−14 |
Active substance: TINZANIDINE |
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Document reference: 44789 |
Study title: Evaluation of a muscle relaxant on sequelae of third molar surgery: a pilot study.Kirmeier R, Truschnegg A, Payer M, Acham S, Schulz K, Jakse N. Oral surgery oral medicine oral pathology oral radiology and endodontics, Sep 2007 (epub: 06 Jul 2007), vol. 104, no. 3,p. e8−14Evaluation of a muscle relaxant on sequelae of third molar surgery: a pilot study.Kirmeier R, Truschnegg A, Payer M, Acham S, Schulz K, Jakse N. Oral surgery oral medicine oral pathology oral radiology and endodontics, Sep 2007 (epub: 06 Jul 2007), vol. 104, no. 3,p. e8−14 |
Active substance: TINZANIDINE |
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Document reference: 44801 |
Study title: Efficacy and safety of Primacor in pediatric patients with congestive heart failure following cardiac surgery. Efficacy and safety of Primacor in pediatric patients with congestive heart failure following cardiac surgery. |
Active substance: MILRINONE |
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Document reference: 32023 |
Study title: Hemodynamic effect of IV milrinone lactate in pediatric patients with septic shock: a prospective, double-blinded, randomized, placebo-controlled, interventional study - Barton P. et al. - 1996 (Chest 1996, 109, 1032-12)Hemodynamic effect of IV milrinone lactate in pediatric patients with septic shock: a prospective, double-blinded, randomized, placebo-controlled, interventional study - Barton P. et al. - 1996 (Chest 1996, 109, 1032-12) |
Active substance: MILRINONE |
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Document reference: 32024 |
Study title: Intravenous arginin-vasopressin in children with vasodilatory shock after cardiac surgery - Rosenzweig EB et al. - 1999 (Circulation, 1999, 100, II 182-6)Intravenous arginin-vasopressin in children with vasodilatory shock after cardiac surgery - Rosenzweig EB et al. - 1999 (Circulation, 1999, 100, II 182-6) |
Active substance: MILRINONE |
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Document reference: 32025 |
Study title: Intravenous milrinone following cardiac surgery: effect of bolus infusion followed by variable dose maintenance infusion - Feneck RO. Et al. - 1992 (J Cardiothorac Anthes 1992, 6, 554-562)Intravenous milrinone following cardiac surgery: effect of bolus infusion followed by variable dose maintenance infusion - Feneck RO. Et al. - 1992 (J Cardiothorac Anthes 1992, 6, 554-562) |
Active substance: MILRINONE |
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Document reference: 32026 |
Study title: Milrinone in the treatment of low output states following cardiac surgery - Wright EM et al. - 1992 (Eur J Anaesthesiol 1992, 5 21-26)Milrinone in the treatment of low output states following cardiac surgery - Wright EM et al. - 1992 (Eur J Anaesthesiol 1992, 5 21-26) |
Active substance: MILRINONE |
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Document reference: 32027 |
Study title: Milrinone: systemic and pulmonary hemodynamic effects in neonates after cardiac surgery - Chang AC et al. - 1995 (Crit. Care Med. 1995, 23, 1907-14)Milrinone: systemic and pulmonary hemodynamic effects in neonates after cardiac surgery - Chang AC et al. - 1995 (Crit. Care Med. 1995, 23, 1907-14) |
Active substance: MILRINONE |
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Document reference: 32028 |
Study title: Pharmacokinetics and pharmacodynamics of milrinone lactate in pediatric patients with septic shock - Lindsay CA. et al. - 1998 (J Pediatr 1998; 132; 329-34)Pharmacokinetics and pharmacodynamics of milrinone lactate in pediatric patients with septic shock - Lindsay CA. et al. - 1998 (J Pediatr 1998; 132; 329-34) |
Active substance: MILRINONE |
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Document reference: 32029 |
Study title: Pharmacokinetics and side effects of milrinone in infants and children after open heart surgery - Ramamoorthy C et al. - 1998 (Anesth. Analg.1998, 86, 283-9)Pharmacokinetics and side effects of milrinone in infants and children after open heart surgery - Ramamoorthy C et al. - 1998 (Anesth. Analg.1998, 86, 283-9) |
Active substance: MILRINONE |
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Document reference: 32030 |
Study title: Platelet activation and aggregation during cardiopulmonary bypass - Rinder CS et al. - 1991 (Anesthesiology, 1991, 75, 388-393)Platelet activation and aggregation during cardiopulmonary bypass - Rinder CS et al. - 1991 (Anesthesiology, 1991, 75, 388-393) |
Active substance: MILRINONE |
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Document reference: 32031 |
Study title: Analgesia for adenotonsillectomy in children and young adults - Van den Berg AA, Montoya-Pelaez LF, Halliday EM, Hassan I, Baloch MS - 1997 (European Journal of Anaesthesiology 1997; 16: 186-194)Analgesia for adenotonsillectomy in children and young adults - Van den Berg AA, Montoya-Pelaez LF, Halliday EM, Hassan I, Baloch MS - 1997 (European Journal of Anaesthesiology 1997; 16: 186-194) |
Active substance: TRAMADOL |
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Document reference: 45018 |
Study title: Anesthesiologic and surgical problems of adenotonsillectomy in paediatric patients. Our current approach - Palmieri AM, Meglio M, Testa D, Salafia M, Lasiello A - 1998 (Minerva Anesthesiol 1998; 64: 545-552)Anesthesiologic and surgical problems of adenotonsillectomy in paediatric patients. Our current approach - Palmieri AM, Meglio M, Testa D, Salafia M, Lasiello A - 1998 (Minerva Anesthesiol 1998; 64: 545-552) |
Active substance: TRAMADOL |
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Document reference: 45020 |
Study title: AWB-MF/TRA/011096, 23-Jul-1997. Post marketing surveillance, Drug monitoring - Therapie mit Tramundin Tropfen N bei mittelstarken bis starken Schmerzen mit verschiedenen Ursachen. (Tramundin oral solution therapy in moderate to severe pain of various origin) (Germany) |
Active substance: TRAMADOL |
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Document reference: 45044 |
Study title: J Nucl Med. 1993 Dec;34(12):2085-9. Comment in: J Nucl Med. 1993 Dec;34(12):2089-90. Clinical evaluation of thallium-201 SPECT in supratentorial gliomas: relationship to histologic grade, prognosis and proliferative activities. Oriuchi N, Tamura M,J Nucl Med. 1993 Dec;34(12):2085-9. Comment in: J Nucl Med. 1993 Dec;34(12):2089-90. Clinical evaluation of thallium-201 SPECT in supratentorial gliomas: relationship to histologic grade, prognosis and proliferative activities. Oriuchi N, Tamura M, |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44614 |
Study title: Cancer J. 2002 Nov-Dec;8(6):469-75. Thallium-201 imaging in evaluation of Hodgkin's disease. Dadparvar S, Hussain R, Esteves F, Yu JQ, Grewal RK, Arif S, Cruz R, Barbaria CJ, Woods K, Styler MJ. Cancer J. 2002 Nov-Dec;8(6):469-75. Thallium-201 imaging in evaluation of Hodgkin's disease. Dadparvar S, Hussain R, Esteves F, Yu JQ, Grewal RK, Arif S, Cruz R, Barbaria CJ, Woods K, Styler MJ. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44528 |
Study title: Cancer. 1997 Oct 15;80(8):1507-12. Thallium-201 scintigraphy for the evaluation of tumor response to preoperative chemotherapy in patients with osteosarcoma. Imbriaco M, Yeh SD, Yeung H, Zhang JJ, Healey JH, Meyers P, Huvos AG, Larson SM. Cancer. 1997 Oct 15;80(8):1507-12. Thallium-201 scintigraphy for the evaluation of tumor response to preoperative chemotherapy in patients with osteosarcoma. Imbriaco M, Yeh SD, Yeung H, Zhang JJ, Healey JH, Meyers P, Huvos AG, Larson SM. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44530 |
Study title: Postoperative course and hemodynamic profile after the arterial switch operation in neonates and infants: a comparison of low-flow ardiopulmonary bypass and circulatory arrest - Wernovsky G et al. - 1995 (Circulation, 1995, 92, 2226-2235)Postoperative course and hemodynamic profile after the arterial switch operation in neonates and infants: a comparison of low-flow ardiopulmonary bypass and circulatory arrest - Wernovsky G et al. - 1995 (Circulation, 1995, 92, 2226-2235) |
Active substance: MILRINONE |
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Document reference: 32032 |
Study title: PRIMACORP: Prophylactic Intravenous use of milrinone after cardiac operation in Pediatrics - Sanofi-Synthelabo Inc - August 2001 |
Active substance: MILRINONE |
Study summary document link (including results): PRIMACORP.pdf |
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Document reference: 32033 |
Study title: Study of the live attenuated Rubella vaccine among adults (≥ 15 years old) |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
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Document reference: 47473 |
Study title: Study of the live attenuated Rubella vaccine among children and adolescent |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
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Document reference: 21212 |
Study title: Vaccination with a live attenuated RA27/3 strain rubella vaccine, a follow up study |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
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Document reference: 41362 |
Study title: A repeat dose, open-label, safety evaluation of a live yeast cell derivative wound healing ointment in out-patients with minor cuts, scrapes, abrasions, and burns |
Active substance: Live Yeast Cell Derivative , Shark Liver Oil |
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Document reference: 40031 |
Study title: Preparation H ointment (WH-66-228) repeated insult patch test |
Active substance: Live Yeast Cell Derivative , Shark Liver Oil |
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Document reference: 40030 |
Study title: Efficacy and safety evaluation of Lodoxamide Ophthalmic Solution versus OPTICROM Ophthalmic Solution in patients with vernal conjunctivitis, giant papillary conjunctivitis and allergic/atopic conjunctivitis (C8559) |
Active substance: LODOXAMIDE |
Study summary document link (including results): |
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Document reference: 46925 |
Study title: Rubella vaccine in school Children |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
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Document reference: 41364 |
Study title: Rubella vaccine in school Children |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
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Document reference: 41456 |
Study title: An open-label study of the safety and efficacy of long-term tiagabine administration in patients with epilepsy3-day treatment with azithromycin 1.5% eye drops versus 7-day treatment with tobramycin 0.3% for purulent bacterial conjunctivitis: multicentre, randomised and controlled trial in adults and children. Cochereau I, Meddeb-Ouertani A, Khairallah M, Amraoui A, Zaghloul K, Pop M, Delval L, Pouliquen P, Tandon R, Garg P, Goldschmidt P, Bourcier T. Br J Ophthalmol. 2007 Apr;91(4):465-9;Epub 2006 Oct 18. |
Active substance: TIAGABINE |
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Document reference: 38528 |
Study title: Kaku Igaku. 1994 Aug;31(8):951-6. [Thallium-201 single photon emission computed tomography in the evaluation of therapeutic response for brain tumors] [Article in Japanese] Tomura N, Kobayashi M, Oyama Y, Satoh K, Kato K, Kusaka K, Watarai J, Sasaki K.Kaku Igaku. 1994 Aug;31(8):951-6. [Thallium-201 single photon emission computed tomography in the evaluation of therapeutic response for brain tumors] [Article in Japanese] Tomura N, Kobayashi M, Oyama Y, Satoh K, Kato K, Kusaka K, Watarai J, Sasaki K. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44645 |
Study title: Comparison of epsilon aminocaproic acid and tranexamic acid in pediatric cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Apr;18(2):141-3.Comparison of epsilon aminocaproic acid and tranexamic acid in pediatric cardiac surgery. J Cardiothorac Vasc Anesth. 2004 Apr;18(2):141-3. |
Active substance: TRAXENAMIC ACID |
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Document reference: 46712 |
Study title: Dose comparison of tranexamic acid in pediatric cardiac surgery. Asian Cardiovasc Thorac Ann. 2004 Jun;12(2):121-4.Dose comparison of tranexamic acid in pediatric cardiac surgery. Asian Cardiovasc Thorac Ann. 2004 Jun;12(2):121-4. |
Active substance: TRAXENAMIC ACID |
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Document reference: 46711 |
Study title: Double-blind trials with ethamsylate, batroxobin or tranexamic acid on blood loss after adenotonsillectomy. Verstraete M., Tyberghein J., De Greef Y. Daems L; Van Hoof A. Acta Clinica Belgica, 32 (2), 136-141 (1977) Tabulated summary, reprint of publicationDouble-blind trials with ethamsylate, batroxobin or tranexamic acid on blood loss after adenotonsillectomy. Verstraete M., Tyberghein J., De Greef Y. Daems L; Van Hoof A. Acta Clinica Belgica, 32 (2), 136-141 (1977) Tabulated summary, reprint of publication |
Active substance: TRAXENAMIC ACID |
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Document reference: 46707 |
Study title: Hemostatic parameters and platelet activation marker expression in cyanotic and acyanotic pediatric patients undergoing cardiac surgery in the presence of tranexamic acid. Thromb Haemost. 2000 Jan;83(1):54-9Hemostatic parameters and platelet activation marker expression in cyanotic and acyanotic pediatric patients undergoing cardiac surgery in the presence of tranexamic acid. Thromb Haemost. 2000 Jan;83(1):54-9 |
Active substance: TRAXENAMIC ACID |
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Document reference: 46716 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Tonico-Injeel (ampoules) [AWB-AT] |
Active substance: Tonico-Injeel |
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Document reference: 40261 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Tonsilla comp. Ampullen (ampoules) [AWB-AT] |
Active substance: Tonsilla compositum-Heel - Ampullen |
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Document reference: 40277 |
Study title: 10. Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in pediatric subjects with uncontrolled partial onset seizures with or without secondarily generalized seizures |
Active substance: TOPIRAMATE |
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Document reference: 44843 |
Study title: 11. Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in subjects with uncontrolled primary generalized tonic-clonic seizures |
Active substance: TOPIRAMATE |
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Document reference: 44844 |
Study title: 12. Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in subjects with uncontrolled primary (PGTC) seizures with or without other generalized seizure subtypes |
Active substance: TOPIRAMATE |
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Document reference: 44845 |
Study title: 13. Phase 3b, open-label, multicenter study designed to evaluate the efficacy and safety of topiramate as adjunctive therapy in pediatric subjects with inadequately controlled partial-onset seizures (with or without secondarily generalized seizures); seizures associated with Lennox-Gastaut Syndrome; and generalized tonic-clonic, myoclonic, or absence seizures. |
Active substance: TOPIRAMATE |
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Document reference: 44877 |
Study title: Am J Cardiol. 1979 Nov;44(6):1040-5. Idiopathic hypertrophic subaortic stenosis: evaluation of anginal symptoms with thallium-201 myocardial imaging. Rubin KA, Morrison J, Padnick MB, Binder AJ, Chiaramida S, Margouleff D, Padmanabhan VT, Gulotta SJ. Am J Cardiol. 1979 Nov;44(6):1040-5. Idiopathic hypertrophic subaortic stenosis: evaluation of anginal symptoms with thallium-201 myocardial imaging. Rubin KA, Morrison J, Padnick MB, Binder AJ, Chiaramida S, Margouleff D, Padmanabhan VT, Gulotta SJ. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44501 |
Study title: Am J Cardiol. 1982 Apr 1;49(5):1197-207. Noninvasive assessment of coronary stenoses by myocardial imaging during pharmacologic coronary vasodilation. VI. Detection of coronary artery disease in human beings with intravenous N-13 ammonia and positron coAm J Cardiol. 1982 Apr 1;49(5):1197-207. Noninvasive assessment of coronary stenoses by myocardial imaging during pharmacologic coronary vasodilation. VI. Detection of coronary artery disease in human beings with intravenous N-13 ammonia and positron co |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44503 |
Study title: Kaku Igaku. 1994 Dec;31(12):1477-94. [201Tl scintigraphic evaluation of tumor mass and viability of bone and soft-tissue tumors] [Article in Japanese] Tsuda T, Kubota M, Yoshida S, Shibata M, Wakabayashi J, Obata H, Matsuyama T, Usui M, Ishii S. Kaku Igaku. 1994 Dec;31(12):1477-94. [201Tl scintigraphic evaluation of tumor mass and viability of bone and soft-tissue tumors] [Article in Japanese] Tsuda T, Kubota M, Yoshida S, Shibata M, Wakabayashi J, Obata H, Matsuyama T, Usui M, Ishii S. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44646 |
Study title: Kaku Igaku. 1994 Jan;31(1):53-61. [Clinical usefulness of thallium-201 chloride in the diagnosis of tumors (I)--Evaluation in brain tumors] [Article in Japanese] Endo K, Yui N, Suzuki K, Torizuka K. Kaku Igaku. 1994 Jan;31(1):53-61. [Clinical usefulness of thallium-201 chloride in the diagnosis of tumors (I)--Evaluation in brain tumors] [Article in Japanese] Endo K, Yui N, Suzuki K, Torizuka K. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44647 |
Study title: Kaku Igaku. 1994 Jan;31(1):63-74. [Clinical usefulness of thallium-201 chloride in the diagnosis of tumor (II)--An evaluation in bone, soft tissue and mediastinal tumors] [Article in Japanese] Tonami N, Itoh K, Yui N, Terui S, Torizuka K. Kaku Igaku. 1994 Jan;31(1):63-74. [Clinical usefulness of thallium-201 chloride in the diagnosis of tumor (II)--An evaluation in bone, soft tissue and mediastinal tumors] [Article in Japanese] Tonami N, Itoh K, Yui N, Terui S, Torizuka K. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44648 |
Study title: Kardiologiia. 1989 Dec;29(12):68-73. [Tl-201 perfusion scintigraphy of the myocardium in patients with anomalous origin of the left coronary artery from the pulmonary trunk (clinico-anatomical comparisons)] [Article in Russian] Malov GA, Oblovatskaia OKardiologiia. 1989 Dec;29(12):68-73. [Tl-201 perfusion scintigraphy of the myocardium in patients with anomalous origin of the left coronary artery from the pulmonary trunk (clinico-anatomical comparisons)] [Article in Russian] Malov GA, Oblovatskaia O |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44650 |
Study title: A Phase IV Multicenter Randomized Double-blind study to assess the antibody response in healthy children aged 3 - 12 years after two vaccinations with FSME-IMMUN Inject |
Active substance: Tick-Borne Encephalitis Virus |
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Document reference: 41106 |
Study title: A phase IV, single-blind, multi-centre, randomized, controlled study to evaluate the safety, tolerability and immunogenicity of two Tick-Borne Encephalitis (TBE) vaccines: Novartis Vaccines's Encepur® Kinder and "licensed comparator" vaccine (Baxter's FSME Immun® Junior) administered according to two different schedules in children. |
Active substance: Tick-Borne Encephalitis Virus |
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Document reference: 48385 |
Study title: Pediatr Hematol Oncol. 2005 Mar;22(2):153-62. Quantitative thallium-201 scintigraphy in childhood osteosarcoma: Comparison with technetuim-99m MDP and magnetic resonance imaging in the evaluation of chemotherapeutic response. Ilhan IE, Vural G, BerberogPediatr Hematol Oncol. 2005 Mar;22(2):153-62. Quantitative thallium-201 scintigraphy in childhood osteosarcoma: Comparison with technetuim-99m MDP and magnetic resonance imaging in the evaluation of chemotherapeutic response. Ilhan IE, Vural G, Berberog |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44681 |
Study title: Pediatr Neurol. 1998 Nov;19(5):351-7. Comparative value of thallium and glucose SPECT imaging in childhood brain tumors. Maria BL, Drane WE, Mastin ST, Jimenez LA. Pediatr Neurol. 1998 Nov;19(5):351-7. Comparative value of thallium and glucose SPECT imaging in childhood brain tumors. Maria BL, Drane WE, Mastin ST, Jimenez LA. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44683 |
Study title: Pediatr Neurosurg. 1991-1992;17(2):95-7. Thallium-201 single-photon emission computed tomography imaging in a pediatric brain tumor. A case report. Bhargava S, Coel M, Wilkinson R. Pediatr Neurosurg. 1991-1992;17(2):95-7. Thallium-201 single-photon emission computed tomography imaging in a pediatric brain tumor. A case report. Bhargava S, Coel M, Wilkinson R. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44685 |
Study title: Pediatr Neurosurg. 1994;20(1):11-8. Value of thallium-201 SPECT imaging in childhood brain tumors. Maria BL, Drane WE, Quisling RG, Ringdahl DM, Mickle JP, Mendenhall NP, Marcus RB Jr, McCollough WM, Hamed LM, Eskin TA, et al. Pediatr Neurosurg. 1994;20(1):11-8. Value of thallium-201 SPECT imaging in childhood brain tumors. Maria BL, Drane WE, Quisling RG, Ringdahl DM, Mickle JP, Mendenhall NP, Marcus RB Jr, McCollough WM, Hamed LM, Eskin TA, et al. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44686 |
Study title: A randomized , open-label, multicenter study with open-label extension of the pharmacokinetics and safety of topiramate administered as the oral liquid and sprinkle formulations as an adjunct to concurrent anticonvulsivant therapy in infants (aged 1 to 24 months, inclusive) with refractory partial-onset seizures |
Active substance: TOPIRAMATE |
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Document reference: 44862 |
Study title: A randomized, double-blind, placebo-controlled, fixe dose-ranging study to assess the safety and tolerability and efficacy of topiramate oral liquid and sprinkle formulations as an adjunct to concurrent anticonvulsivant therapy for infants (1 to 23 months of age, inclusive) with refractoty partial onset seizures, with open-label extension. |
Active substance: TOPIRAMATE |
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Document reference: 44863 |
Study title: A randomized, open label extension of the pharmacokinetics and safety of topiramate administered as the oral liquid and sprinkle formulations as an adjunct to concurrent anticonvulsivant therapy in infants (Aged 1 to 24 months, inclusive) with refractory partial-onset seizures |
Active substance: TOPIRAMATE |
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Document reference: 44932 |
Study title: Am J Cardiol. 1990 May 1;65(16):1134-9. Decreased coronary vasodilatory capacity in hypertrophic cardiomyopathy determined by split-dose thallium-dipyridamole myocardial scintigraphy. Koga Y, Yamaguchi R, Ogata M, Kihara K, Toshima H. Am J Cardiol. 1990 May 1;65(16):1134-9. Decreased coronary vasodilatory capacity in hypertrophic cardiomyopathy determined by split-dose thallium-dipyridamole myocardial scintigraphy. Koga Y, Yamaguchi R, Ogata M, Kihara K, Toshima H. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44505 |
Study title: Am J Cardiol. 1992 Nov 1;70(13):1109-12. Detection of silent coronary artery disease in adolescents and young adults with familial hypercholesterolemia by single-photon emission computed tomography thallium-201 scanning. Mouratidis B, Vaughan-Neil EF, Am J Cardiol. 1992 Nov 1;70(13):1109-12. Detection of silent coronary artery disease in adolescents and young adults with familial hypercholesterolemia by single-photon emission computed tomography thallium-201 scanning. Mouratidis B, Vaughan-Neil EF, |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44507 |
Study title: Caudal bupivacaine-tramadol combination for postoperative analgesia in paediatric herniorrhaphy - Senel AC, Akyol A, Dohman D, Solak M, - 2001 (Acta. Anaesthesiologiol. Scand, 2001; 45: 786-789)Caudal bupivacaine-tramadol combination for postoperative analgesia in paediatric herniorrhaphy - Senel AC, Akyol A, Dohman D, Solak M, - 2001 (Acta. Anaesthesiologiol. Scand, 2001; 45: 786-789) |
Active substance: TRAMADOL |
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Document reference: 45021 |
Study title: Investigator's study (Dr. Rudolf Schosser): Post-authorisation observation Study, Booster Vaccination with FSME-IMMUN Adult und FSME-IMMUN 0,25ml Junior to achieve Protection if Irregular Vaccination scheme have occured in the vaccination history (duration: May 2005 - December 2006) |
Active substance: Tick-Borne Encephalitis Virus |
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Document reference: 41102 |
Study title: Multicenter Phase IV Study to Investigate the Seropersistence of TBE Virus Antibodies Approximately Three Years After a Booster Vaccination with FSME-Immun 0.25 ml Junior in Children (Follow-up to Study 146A and 180) |
Active substance: Tick-Borne Encephalitis Virus |
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Document reference: 41103 |
Study title: Multizentrische offene Studie zur Untersuchung der FSME-Antikörper 1 Jahr nach Impfung mit 0,25 oder 0,50 ml TicoVac - Anschlußstudie an die FSME-Kinderstudie 146 |
Active substance: Tick-Borne Encephalitis Virus |
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Document reference: 21214 |
Study title: Multizentrische offene Studie zur Untersuchung der FSME-Antikörper 1 Jahr nach Impfung mit 0,25 oder 0,50 ml TicoVac - Anschlußstudie an die FSME-Kinderstudie 146 |
Active substance: Tick-Borne Encephalitis Virus |
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Document reference: 41105 |
Study title: A phase III, controlled, open-label, randomized, multicenter study in children: evaluating the immunogenicity and safety of Novartis pediatric Tick Borne Encephalitis (TBE) vaccine using three different immunization schedules. |
Active substance: Tick-Borne Encephalitis Virus |
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Document reference: 48396 |
Study title: Phase III, observer-blind, randomized, study to evaluate the safety and immunogenicity using three doses of polygeline free tick-borne encephalitis (TBE) vaccine in adolescents and adults. |
Active substance: Tick-Borne Encephalitis Virus |
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Document reference: 48398 |
Study title: Phase IV multicenter, open label extension study of the long-term immunogenicity of a single booster dose of polygeline-free tick borne encephalitis (TBE) vaccine in children. |
Active substance: Tick-Borne Encephalitis Virus |
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Document reference: 48399 |
Study title: Phase IV multicenter, open label extension study of the long-term immunogenicity of a single booster dose of polygeline-free tick borne encephalitis (TBE) vaccine in children. |
Active substance: Tick-Borne Encephalitis Virus |
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Document reference: 48400 |
Study title: Single-blind, randomized, multicenter comparison of FSME IMMUN NEW and ENCEPUR: safety and tolerability of two vaccinations in healthy volunteers aged 16 to 65 years |
Active substance: Tick-Borne Encephalitis Virus |
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Document reference: 21204 |
Study title: Acute oral toxicity in the baboon (LSR report n°76/CAS4/176) - Lightowler - 28 July 1976 |
Active substance: TICLOPIDINE |
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Document reference: 44755 |
Study title: Pharmacocinetique de la ticlopidine à dose unique et doses répétées chez des volontaires sains jeunes et agés. Rapport final. ICM 1161/ CL 3690 - Gabuzda G. - 01/12/86 |
Active substance: TICLOPIDINE |
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Document reference: 44759 |
Study title: Publication: Effect of vitamin E and ticlopidine on platelet aggregation in Fabry's disease. Clin Gen; 31:349-54 - Sakuraba - 4 January 1987 |
Active substance: TICLOPIDINE |
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Document reference: 44756 |
Study title: Publication: Treatment of angiomas with associated thrombocytopenia (Kasabach-Merrit syndrome) by ticlopidine-aspirin combination - Drouet - No date |
Active substance: TICLOPIDINE |
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Document reference: 44757 |
Study title: Studies on platelet functions and the protection of platelet consumption during extracorporeal circulation -Isomura - No date |
Active substance: TICLOPIDINE |
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Document reference: 44758 |
Study title: Circulation. 1980 Mar;61(3):596-9. Thallium-201 myocardial perfusion imaging in infants and children. Value in distinguishing anomalous left coronary artery from congestive cardiomyopathy. Gutgesell HP, Pinsky WW, DePuey EG. Circulation. 1980 Mar;61(3):596-9. Thallium-201 myocardial perfusion imaging in infants and children. Value in distinguishing anomalous left coronary artery from congestive cardiomyopathy. Gutgesell HP, Pinsky WW, DePuey EG. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44534 |
Study title: (The impact of diltiazem on aminophylline serum concentration−−a clinical study). Li X, Zhao JP, Chen BG. Zhonghua nei ke za zhi (Chinese journal of internal medicine),Nov 1994, vol. 33, no. 11, p. 773−5(The impact of diltiazem on aminophylline serum concentration−−a clinical study). Li X, Zhao JP, Chen BG. Zhonghua nei ke za zhi (Chinese journal of internal medicine),Nov 1994, vol. 33, no. 11, p. 773−5 |
Active substance: DILTIAZEM |
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Document reference: 26131 |
Study title: Evaluation of the optimal dose of topiramate in epilepsy monotherapy |
Active substance: TOPIRAMATE |
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Document reference: 44847 |
Study title: Comparison of caudal tramadol versus bupivacaine for postoperative analgesia in children undergoing hypospadis surgery - Batra YK, Prasad MK, Arya VK, Chari P, Yaddnapudi LN - 1999 (Int J Clin Pharmacol Ther. 1999; 37(5): 238-242)Comparison of caudal tramadol versus bupivacaine for postoperative analgesia in children undergoing hypospadis surgery - Batra YK, Prasad MK, Arya VK, Chari P, Yaddnapudi LN - 1999 (Int J Clin Pharmacol Ther. 1999; 37(5): 238-242) |
Active substance: TRAMADOL |
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Document reference: 45024 |
Study title: Control of postoperative pain with tramadol in paediatric and adolescent patients with neurological lesions: our experience - Girotto T, Padovan L, Muraretto P, Marazza D, Marzeolini M, De Nobili E - 1998 (Acta Anaesth Italica 1998; 49: 257-262)Control of postoperative pain with tramadol in paediatric and adolescent patients with neurological lesions: our experience - Girotto T, Padovan L, Muraretto P, Marazza D, Marzeolini M, De Nobili E - 1998 (Acta Anaesth Italica 1998; 49: 257-262) |
Active substance: TRAMADOL |
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Document reference: 45026 |
Study title: J Orthop Sci. 1998;3(6):297-303. Value of thallium-201 scintigraphy in bone and soft tissue tumors. Sato O, Kawai A, Ozaki T, Kunisada T, Danura T, Inoue H. J Orthop Sci. 1998;3(6):297-303. Value of thallium-201 scintigraphy in bone and soft tissue tumors. Sato O, Kawai A, Ozaki T, Kunisada T, Danura T, Inoue H. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44622 |
Study title: A CLINICAL STUDY ENTITLED TIOCONAZOL 6,5% SINGLE DOSE VAGINAL OINTMENT IN THE TREATMENT OF VAGINAL CANDIDASIS (DR. GRIGORIU ET ALL) (MULTICENTER STUDY) |
Active substance: TIOCONAZOLE |
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Document reference: 44807 |
Study title: Eur J Nucl Med. 1995 Jun;22(6):553-5. Quantitative evaluation of thallium-201 uptake in predicting chemotherapeutic response of osteosarcoma. Lin J, Leung WT, Ho SK, Ho KC, Kumta SM, Metreweli C, Johnson PJ. Eur J Nucl Med. 1995 Jun;22(6):553-5. Quantitative evaluation of thallium-201 uptake in predicting chemotherapeutic response of osteosarcoma. Lin J, Leung WT, Ho SK, Ho KC, Kumta SM, Metreweli C, Johnson PJ. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44570 |
Study title: J Surg Oncol. 1990 Dec;45(4):282-8. Multiple endocrine neoplasia type IIb: a clinicopathological report. Van Zyl JA, Muller GS, Rossouw DJ, Van Velden DJ. J Surg Oncol. 1990 Dec;45(4):282-8. Multiple endocrine neoplasia type IIb: a clinicopathological report. Van Zyl JA, Muller GS, Rossouw DJ, Van Velden DJ. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44627 |
Study title: J Thorac Cardiovasc Surg. 1984 Jan;87(1):59-65. Single-trunk anomalous origin of both coronary arteries from the pulmonary artery. Diagnosis and surgical management. J Thorac Cardiovasc Surg. 1984 Jan;87(1):59-65. Single-trunk anomalous origin of both coronary arteries from the pulmonary artery. Diagnosis and surgical management. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44628 |
Study title: Efficacy of neuroprotectors in patients with tension headaches. Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6Efficacy of neuroprotectors in patients with tension headaches. Medvedeva LA, Gnezdilov AV, Zagorul ko OI, Syrovegin AV, Samoilova NV. Neuroscience and behavioral physiology, Jun 2007, vol. 37, no. 5, p. 523−6 |
Active substance: TIAGABINE |
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Document reference: 38504 |
Study title: Tramal in the treatment of pain in children with malignancies - Kralinski K, Dluholucky S, Bajciova V, LahoL, Drobova Z - 1994 (Klinicka Onkologie 1994; 6: 182-185)Tramal in the treatment of pain in children with malignancies - Kralinski K, Dluholucky S, Bajciova V, LahoL, Drobova Z - 1994 (Klinicka Onkologie 1994; 6: 182-185) |
Active substance: TRAMADOL |
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Document reference: 45039 |
Study title: The effect of preoperative tranexamic acid on blood loss after cardiac operations in children. J Thorac Cardiovasc Surg. 1996 May;111(5):982-7.The effect of preoperative tranexamic acid on blood loss after cardiac operations in children. J Thorac Cardiovasc Surg. 1996 May;111(5):982-7. |
Active substance: TRAXENAMIC ACID |
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Document reference: 46719 |
Study title: Health Phys. 1989 Apr;56(4):539-41. Thallium-201 in human milk: observations and radiological consequences. Murphy PH, Beasley CW, Moore WH, Stabin MG. Health Phys. 1989 Apr;56(4):539-41. Thallium-201 in human milk: observations and radiological consequences. Murphy PH, Beasley CW, Moore WH, Stabin MG. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44577 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Thalamus compositum (ampoules) [AWB-AT] |
Active substance: Thalamus compositum-Heel - Ampullen |
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Document reference: 40254 |
Study title: Ann Nucl Med. 1990 Jul;4(2):59-65. Evaluation of viral myocarditis in children by radionuclide method. Kawamura Y, Morishita T, Yamazaki J, Okuzumi I, Wakakura M, Muto T, Saji T, Matsuura H, Matsuo N, Yabe Y. Ann Nucl Med. 1990 Jul;4(2):59-65. Evaluation of viral myocarditis in children by radionuclide method. Kawamura Y, Morishita T, Yamazaki J, Okuzumi I, Wakakura M, Muto T, Saji T, Matsuura H, Matsuo N, Yabe Y. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44511 |
Study title: Kokyu To Junkan. 1987 Jan;35(1):59-64. [Clinical evaluation of thallium-201 myocardial scintigram in myocarditis] [Article in Japanese] Shimonagata T, Nishimura T, Hayashida K, Uehara T, Takamiya M. Kokyu To Junkan. 1987 Jan;35(1):59-64. [Clinical evaluation of thallium-201 myocardial scintigram in myocarditis] [Article in Japanese] Shimonagata T, Nishimura T, Hayashida K, Uehara T, Takamiya M. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44654 |
Study title: Kokyu To Junkan. 1990 Dec;38(12):1247-51. [Usefulness for evaluation of the left ventricular disorders by apexcardiographic A-wave ratio in patients with hypertrophic cardiomyopathy] [Article in Japanese] Yada T, Nezuo S, Sawayama T, Hasegawa K, TadaokKokyu To Junkan. 1990 Dec;38(12):1247-51. [Usefulness for evaluation of the left ventricular disorders by apexcardiographic A-wave ratio in patients with hypertrophic cardiomyopathy] [Article in Japanese] Yada T, Nezuo S, Sawayama T, Hasegawa K, Tadaok |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44657 |
Study title: Kokyu To Junkan. 1991 Apr;39(4):355-60. [Evaluation of myocarditis using T1-201 myocardial scintigraphy with bull's eye functional map] [Article in Japanese] Satoh K, Utsumi J, Satoh H, Kasuya H, Mitsuyama H, Nakata Y, Yamaguchi H, Kawai Y, Okada R, KaKokyu To Junkan. 1991 Apr;39(4):355-60. [Evaluation of myocarditis using T1-201 myocardial scintigraphy with bull's eye functional map] [Article in Japanese] Satoh K, Utsumi J, Satoh H, Kasuya H, Mitsuyama H, Nakata Y, Yamaguchi H, Kawai Y, Okada R, Ka |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44658 |
Study title: Kurume Med J. 1992;39(4):245-55. Myocardial ischemia in Kawasaki disease; evaluation by dipyridamole stress thallium-201 (Tl-201) myocardial imaging and exercise stress test. Fukuda T. Kurume Med J. 1992;39(4):245-55. Myocardial ischemia in Kawasaki disease; evaluation by dipyridamole stress thallium-201 (Tl-201) myocardial imaging and exercise stress test. Fukuda T. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44660 |
Study title: Kurume Med J. 1992;39(4):267-78. Clinical significance of thallium-201 single-photon emission computerized tomography (Tl-201 SPECT) in the evaluation of viability of gliomas. Taguchi A. Kurume Med J. 1992;39(4):267-78. Clinical significance of thallium-201 single-photon emission computerized tomography (Tl-201 SPECT) in the evaluation of viability of gliomas. Taguchi A. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44661 |
Study title: Ticlopidine. Chronic glomeruloneprhitis (pilot study) - Narita - 21 June 1977 |
Active substance: TICLOPIDINE |
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Document reference: 44761 |
Study title: Radiology. 1979 Sep;132(3):707-10. Computed tomography of the heart using thallium-201 in children. Treves S, Hill TC, VanPraagh R, Holman BL. Radiology. 1979 Sep;132(3):707-10. Computed tomography of the heart using thallium-201 in children. Treves S, Hill TC, VanPraagh R, Holman BL. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44694 |
Study title: Open label pilot study to evaluate the efficacy and safety of escalating doses of topamax (topiramate) in the treatment of typical absence seizures in children. Phase ii |
Active substance: TOPIRAMATE |
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Document reference: 44851 |
Study title: Open label pilot study to evaluate the efficacy and safety of escalating doses of topamax (topiramate) in the treatment of typical absence seizures in children. Phase II |
Active substance: TOPIRAMATE |
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Document reference: 44909 |
Study title: Open label pilot study to evaluate the efficacy and safety of escalating doses of topamax (topiramate) in the treatment of typical absence seizures in children. Phase II. |
Active substance: TOPIRAMATE |
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Document reference: 44942 |
Study title: Ann Nucl Med. 1993 Aug;7(3):147-52. Thallium-201 scintigraphy in the evaluation of thyroid nodules. A retrospective study of 246 cases. Koizumi M, Taguchi H, Goto M, Nomura T, Watari T. Ann Nucl Med. 1993 Aug;7(3):147-52. Thallium-201 scintigraphy in the evaluation of thyroid nodules. A retrospective study of 246 cases. Koizumi M, Taguchi H, Goto M, Nomura T, Watari T. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44512 |
Study title: Ann Nucl Med. 1994 Feb;8(1):71-4. Cardiac involvement of progressive muscular dystrophy (Becker type, Limb-girdle type and Fukuyama type) evaluated by radionuclide method. Nagamachi S, Inoue K, Jinnouchi S, Hoshi H, Ono S, Ohnishi T, Futami S, Watanabe Ann Nucl Med. 1994 Feb;8(1):71-4. Cardiac involvement of progressive muscular dystrophy (Becker type, Limb-girdle type and Fukuyama type) evaluated by radionuclide method. Nagamachi S, Inoue K, Jinnouchi S, Hoshi H, Ono S, Ohnishi T, Futami S, Watanabe |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44513 |
Study title: Evaluation of the population pharmacokinetic properties of tramadol (T) and Odemethyltramadol (M1) in children and the relation between exposure to T and M1 and different measurements of efficacy, based on data coming from study WIS-AL-TRA-PCP1 |
Active substance: TRAMADOL |
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Document reference: 45005 |
Study title: Evaluation of the safety profile and clinical effectiveness of oral tramadol hydrochloride tablets for the treatment of postsurgical pain in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-005; Phase 2) |
Active substance: TRAMADOL |
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Document reference: 44979 |
Study title: Evaluation of the Safety Profile and Clinical Effectiveness of Two Dosing Levels of Oral Tramadol Hydrochloride with Acetaminophen for the Treatment of Postsurgical Pain in Children and Adolescents Aged Seven to Sixteen Years |
Active substance: TRAMADOL |
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Document reference: 44976 |
Study title: Tclid. Acute and chronic pharmacokinetic study of ticlopidine hydrochloride in young and old normal subjects. Final report. ICM 1161/ CL 3690 - Gabuzda G. - 01/12/86 |
Active substance: TICLOPIDINE |
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Document reference: 44760 |
Study title: Response to travoprost in black and nonblack patients with open-angle glaucoma or ocular hypertension. Netland PA, Robertson SM, Sullivan EK, Silver L, Bergamini MV, Krueger S, Weiner AL, Davis AA; Travoprost Study Groups. Adv Ther. 2003 May-Jun;20(3):149-63. Response to travoprost in black and nonblack patients with open-angle glaucoma or ocular hypertension. Netland PA, Robertson SM, Sullivan EK, Silver L, Bergamini MV, Krueger S, Weiner AL, Davis AA; Travoprost Study Groups. Adv Ther. 2003 May-Jun;20(3):149-63. |
Active substance: TIMOLOL |
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Document reference: 44763 |
Study title: A Multicentre Study for the Evaluation of the Clinical Efficacy and of Local and General Safety of Tioconazole in the Gynaecological Use |
Active substance: TIOCONAZOLE |
Study summary document link (including results): TCN-I-88-004 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 48033 |
Study title: A NON COMPARATIVE MULTICENTER STUDY OF TIOCONAZOLE 300MG VAGINAL OVULES FO THE SINGLE DOSE TREATMENT OF VAGINAL YEAST INFECTIONS |
Active substance: TIOCONAZOLE |
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Document reference: 44806 |
Study title: A NON-COMPARATIVE MULTICENTER STUDY OF TIOCONAZOLE 100MG VAGINAL OVULES FOR THE TREATMENT OF VAGINAL CANDIDIASIS WITH A 3 DAY COURSE OF THERAPY |
Active substance: TIOCONAZOLE |
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Document reference: 44809 |
Study title: OPEN STUDY OF THE EFFICACY AND TOLERATION OF TIOCONAZOLE SINGLE DOSE OINTMENT IN THE TREATMENT OF PATIENTS WITH VAGINAL CANDIDOSIS (PEIOS SWITZERLAND) |
Active substance: TIOCONAZOLE |
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Document reference: 44811 |
Study title: Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in subjects with uncontrolled primary eneralized tonic-clonic seizures. |
Active substance: TOPIRAMATE |
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Document reference: 44895 |
Study title: Phase 3, double-blind, PBO-controlled, parallel group, add-on trial to evaluate the safety and efficacy study of TPM vs. PBO as adjunctive therapy in subjects with uncontrolled primary (PGTC) seizures with or without other generalized seizure subtypes. |
Active substance: TOPIRAMATE |
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Document reference: 44896 |
Study title: J Cardiogr. 1986 Jun;16(2):373-85. [Myocardial involvement in muscular dystrophy evaluated by thallium-201 emission computed tomography] [Article in Japanese] Yamamoto S, Matsushima H, Kawai N, Sotobata I. J Cardiogr. 1986 Jun;16(2):373-85. [Myocardial involvement in muscular dystrophy evaluated by thallium-201 emission computed tomography] [Article in Japanese] Yamamoto S, Matsushima H, Kawai N, Sotobata I. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44598 |
Study title: Evaluation of the multiple-dose steady-state pharmacokinetic profile or oral tramadol HCl in children and adolescents aged seven to sisteen years - Multicenter - 2000 |
Active substance: TRAMADOL |
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Document reference: 45028 |
Study title: J Thorac Cardiovasc Surg. 1997 May;113(5):942-8. Comment in: J Thorac Cardiovasc Surg. 1997 Dec;114(6):1127-8. Effect of preoperative supplementation with alpha-tocopherol and ascorbic acid on myocardial injury in patients undergoing cardiac operatiJ Thorac Cardiovasc Surg. 1997 May;113(5):942-8. Comment in: J Thorac Cardiovasc Surg. 1997 Dec;114(6):1127-8. Effect of preoperative supplementation with alpha-tocopherol and ascorbic acid on myocardial injury in patients undergoing cardiac operati |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44629 |
Study title: J Thorac Cardiovasc Surg. 1999 Feb;117(2):352-7. Surgical angioplasty of the main coronary arteries in children. Bonnet D, Bonhoeffer P, Sidi D, Kachaner J, Acar P, Villain E, Vouhé PR. J Thorac Cardiovasc Surg. 1999 Feb;117(2):352-7. Surgical angioplasty of the main coronary arteries in children. Bonnet D, Bonhoeffer P, Sidi D, Kachaner J, Acar P, Villain E, Vouhé PR. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44630 |
Study title: Clin Nucl Med. 1992 Mar;17(3):191-4. Noninvasive assessment of myocardium at risk by Tl-201 SPECT imaging in a child with Kawasaki disease. A case report. Civelek AC, Kavanaugh-McHugh A, Ozguven MA, Durski K, Camargo EE. Clin Nucl Med. 1992 Mar;17(3):191-4. Noninvasive assessment of myocardium at risk by Tl-201 SPECT imaging in a child with Kawasaki disease. A case report. Civelek AC, Kavanaugh-McHugh A, Ozguven MA, Durski K, Camargo EE. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44549 |
Study title: Clin Nucl Med. 1993 Jul;18(7):551-7. The role of thallium scintigraphy in excluding malignancy in bone. Van der Wall H, Murray IP, Huckstep RL, Philips RL. Clin Nucl Med. 1993 Jul;18(7):551-7. The role of thallium scintigraphy in excluding malignancy in bone. Van der Wall H, Murray IP, Huckstep RL, Philips RL. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44551 |
Study title: OPEN STUDY OF THE EFFICACY AND TOLERATION OF TIOCONAZOLE SINGLE DOSE OINTMENT IN THE TREATMENT OF PATIENTS WITH VAGINAL CANDIDOSIS (ARTNER AUSTRIA) |
Active substance: TIOCONAZOLE |
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Document reference: 44812 |
Study title: OPEN STUDY OF THE EFFICACY AND TOLERATION OF TIOCONAZOLE SINGLE DOSE OINTMENT IN THE TREATMENT OF PATIENTS WITH VAGINAL CANDIDOSIS (GRANETZNY WEST GERMANY) |
Active substance: TIOCONAZOLE |
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Document reference: 44813 |
Study title: OPEN STUDY OF THE EFFICACY AND TOLERATION OF TIOCONAZOLE SINGLE DOSE OINTMENT IN THE TREATMENT OF PATIENTS WITH VAGINAL CANDIOSIS (DR PEIOS SWITZERLAND) |
Active substance: TIOCONAZOLE |
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Document reference: 44814 |
Study title: A comparative trial of DS 103-282 and diazepam in patients with spasticity due to cerebrovascular accidents |
Active substance: TIZANIDINE |
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Document reference: 44779 |
Study title: Int J Cardiol. 1986 Sep;12(3):309-20. Systolic compression of coronary artery in hypertrophic cardiomyopathy. Navarro-Lopez F, Soler J, Magriña J, Esplugues E, Pare JC, Sanz G, Betriu A. Int J Cardiol. 1986 Sep;12(3):309-20. Systolic compression of coronary artery in hypertrophic cardiomyopathy. Navarro-Lopez F, Soler J, Magriña J, Esplugues E, Pare JC, Sanz G, Betriu A. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44581 |
Study title: Int J Cardiol. 1989 Aug;24(2):219-24. Hemodynamic and prognostic value of thallium-201 myocardial imaging in patients with dilated cardiomyopathy. Tamai J, Nagata S, Nishimura T, Yutani C, Miyatake K, Sakakibara H, Nimura Y. Int J Cardiol. 1989 Aug;24(2):219-24. Hemodynamic and prognostic value of thallium-201 myocardial imaging in patients with dilated cardiomyopathy. Tamai J, Nagata S, Nishimura T, Yutani C, Miyatake K, Sakakibara H, Nimura Y. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44582 |
Study title: J Cardiol. 1992;22(1):21-6. [Ischemic myocardial injury evaluated using positron emission tomography in children with coronary artery disease: comparison with thallium-201 SPECT] [Article in Japanese] Yoshibayashi M, Tamaki N, Nishioka K, Matsumura M, J Cardiol. 1992;22(1):21-6. [Ischemic myocardial injury evaluated using positron emission tomography in children with coronary artery disease: comparison with thallium-201 SPECT] [Article in Japanese] Yoshibayashi M, Tamaki N, Nishioka K, Matsumura M, |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44600 |
Study title: Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396 Van Santen HM. Improved Radiation Protection of the Thyroid Gland with Thyroxine, Methimazole, and Potassium Iodide during Diagnostic and Therapeutic Use of Radiolabeled Metaiodobenzylguanidine in Children with Neuroblastoma, Cancer 2003; 98: 389-396 |
Active substance: THIAMAZOLE |
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Document reference: 44735 |
Study title: Jpn Heart J. 1985 Sep;26(5):767-75. Evaluation of myocardial involvement in Duchenne's progressive muscular dystrophy with thallium-201 myocardial perfusion imaging. Kawai N, Sotobata I, Okada M, Iwase M, Yamamoto S, Matsushima H, Miyakoda H, Yokota M, Jpn Heart J. 1985 Sep;26(5):767-75. Evaluation of myocardial involvement in Duchenne's progressive muscular dystrophy with thallium-201 myocardial perfusion imaging. Kawai N, Sotobata I, Okada M, Iwase M, Yamamoto S, Matsushima H, Miyakoda H, Yokota M, |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44636 |
Study title: Safety and Efficacy of Tiagabine HCl Monotherapy for the Inpatient Treatment of Complex Partial Seizures: A Placebo–Controlled Study |
Active substance: TIAGABINE |
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Document reference: 38520 |
Study title: Use of tramal during minor surgery in children - Ostreykov IF, Senkov Vn, Kurilova ES, Bershinksy VP, Pivovarov SA, Babayev BD - 1993 (Anesthesiol Resuscitation 1993; 24: 28-31)Use of tramal during minor surgery in children - Ostreykov IF, Senkov Vn, Kurilova ES, Bershinksy VP, Pivovarov SA, Babayev BD - 1993 (Anesthesiol Resuscitation 1993; 24: 28-31) |
Active substance: TRAMADOL |
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Document reference: 45042 |
Study title: Evaluation and comparison of safety and effectiveness of L.A.N.D., phenylephrine, and a vehicle control in patients with allergic and non-allergic rhinitis. |
Active substance: TRAMAZOLINE |
Study summary document link (including results): Tramazoline Hydrochloride_U70-0210_synopsis.pdf |
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Document reference: 46699 |
Study title: Evaluation of the effects of L.A.N.D., phenylephrine, and vehicle control nasal sprays in children with acute and chronic rhinitis due to coryza or allergy. |
Active substance: TRAMAZOLINE |
Study summary document link (including results): Tramazoline Hydrochloride_U70-0222_synopsis.pdf |
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Document reference: 46700 |
Study title: CLINICAL EVALUATION OF DIFLUCAN ON SEVERE CANDIDEMIA |
Active substance: FLUCONAZOLE |
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Document reference: 27536 |
Study title: Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1503-6. Thallium-201 scintigraphy is not predictive of late cardiac complications in patients with Hodgkin's disease treated with mediastinal radiation. Girinsky T, Cordova A, Rey A, Cosset JM, Tertian G, PInt J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1503-6. Thallium-201 scintigraphy is not predictive of late cardiac complications in patients with Hodgkin's disease treated with mediastinal radiation. Girinsky T, Cordova A, Rey A, Cosset JM, Tertian G, P |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44585 |
Study title: Data collection for observational study (AWB) on tolerability of thyme preparations in children up to 12 years |
Active substance: Thyme , liquid extract (1:2-2,5) |
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Document reference: 40256 |
Study title: Muz V.A., Zubkova S.T. : Effects of antihomotoxic Thyreoidea compositum preparation in the treatment of children suffering from autoimmune thyreoiditis. Biological Therapy (Ukraine), 2003, 3: 31-34 [IIT-publication]; |
Active substance: Thyreoidea compositum |
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Document reference: 40259 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Thyreoidea compositum (ampoules) [AWB-AT] |
Active substance: Thyreoidea compositum |
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Document reference: 40260 |
Study title: Sysoeva N.A: Dynamics of selected homeostatic parameters in children suffering from thyroid gland pathology under the influence of combined treatment. Therapeutic Medico-Biological Vestnik, 2006, 9(2) [IIT-publication]; |
Active substance: Thyreoidea compositum |
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Document reference: 40258 |
Study title: Acta Radiol Suppl. 1992;378 ( Pt 3):51-70. Polar presentation of coronary angiography and thallium-201 single photon emission computed tomography. Studies of patients examined for heart disease. Svane B. Acta Radiol Suppl. 1992;378 ( Pt 3):51-70. Polar presentation of coronary angiography and thallium-201 single photon emission computed tomography. Studies of patients examined for heart disease. Svane B. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44486 |
Study title: AJNR Am J Neuroradiol. 1991 Nov-Dec;12(6):1187-92. Radiation necrosis vs high-grade recurrent glioma: differentiation by using dual-isotope SPECT with 201TI and 99mTc-HMPAO. Schwartz RB, Carvalho PA, Alexander E 3rd, Loeffler JS, Folkerth R, Holman BL. AJNR Am J Neuroradiol. 1991 Nov-Dec;12(6):1187-92. Radiation necrosis vs high-grade recurrent glioma: differentiation by using dual-isotope SPECT with 201TI and 99mTc-HMPAO. Schwartz RB, Carvalho PA, Alexander E 3rd, Loeffler JS, Folkerth R, Holman BL. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44489 |
Study title: Aust N Z J Med. 1998 Feb;28(1):33-8. Erratum in: Aust N Z J Med 1998 Apr;28(2):197. Comparison of thallium-201 and gallium-67 scintigraphy in the evaluation of non-Hodgkin's lymphoma. Roach PJ, Cooper RA, Arthur CK, Ravich RB. Aust N Z J Med. 1998 Feb;28(1):33-8. Erratum in: Aust N Z J Med 1998 Apr;28(2):197. Comparison of thallium-201 and gallium-67 scintigraphy in the evaluation of non-Hodgkin's lymphoma. Roach PJ, Cooper RA, Arthur CK, Ravich RB. |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44524 |
Study title: Nippon Igaku Hoshasen Gakkai Zasshi. 1989 Dec 25;49(12):1567-72. [Clinical evaluation of Tl-201 ECG-gated myocardial SPECT--comparison with ECG-gated blood pool SPECT] [Article in Japanese] Mochizuki T. Nippon Igaku Hoshasen Gakkai Zasshi. 1989 Dec 25;49(12):1567-72. [Clinical evaluation of Tl-201 ECG-gated myocardial SPECT--comparison with ECG-gated blood pool SPECT] [Article in Japanese] Mochizuki T. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44669 |
Study title: AJNR Am J Neuroradiol. 2000 May;21(5):901-9. Posttherapeutic intraaxial brain tumor: the value of perfusion-sensitive contrast-enhanced MR imaging for differentiating tumor recurrence from nonneoplastic contrast-enhancing tissue. Sugahara T, Korogi Y, TAJNR Am J Neuroradiol. 2000 May;21(5):901-9. Posttherapeutic intraaxial brain tumor: the value of perfusion-sensitive contrast-enhanced MR imaging for differentiating tumor recurrence from nonneoplastic contrast-enhancing tissue. Sugahara T, Korogi Y, T |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44492 |
Study title: Phase 3, randomized, double-blind, placebo-controlled, parallel study with an open-label extension designed to evaluate the safety and efficacy of topiramate in subjects 6 to 15 years of age who had headache symptoms that met the proposed IHS Classification of Pediatric Migraine with or without aura. |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44935 |
Study title: Phase 3b, open-label, multicenter study designed to evaluate the efficacy and safety of topiramate as adjunctive therapy in pediatric subjects with inadequately controlled partial-onset seizures (with or without secondarily generalized seizures); seizures associated with Lennox-Gastaut Syndrome; and generalized tonic-clonic, myoclonic, or absence seizures. |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44886 |
Study title: Phase 3b, open-label, multicenter study designed to evaluate the efficacy and safety of topiramate as adjunctive therapy in pediatric subjects with inadequately controlled-seizures (with or without secondarily genralized seizures) seizures. Open label extension study of the safety and efficacy of rwj-17021-001 in subjects with bipolar disorder who completed topmat-pdmd-002. A placebo-controlled 12-week study of the safety and efficacy of one dose of topiramate versus lithium for the treatment of acute manic or mixed episodes in subjects with bipolar disorder I with an optional open-label extension. |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44914 |
Study title: Prospective evaluation of epilepsy treatment with topiramate |
Active substance: TOPIRAMATE |
Study summary document link (including results): |
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Document reference: 44869 |
Study title: Retrospective, non-interventional evaluation of pharmacovigilance and clinical experiences with topiramate in the treatment of epilepsy in Slovakia |
Active substance: TOPIRAMATE |
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Document reference: 44934 |
Study title: Safety and efficacy of Topamax in monotherapy or combined therapy in children and adult patient with epilepsy in an observational study with medium duration of 6 months. |
Active substance: TOPIRAMATE |
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Document reference: 44925 |
Study title: Arch Intern Med. 1992 Apr;152(4):769-72. Utility of various radionuclide techniques for distinguishing ischemic from nonischemic dilated cardiomyopathy. Glamann DB, Lange RA, Corbett JR, Hillis LD. Arch Intern Med. 1992 Apr;152(4):769-72. Utility of various radionuclide techniques for distinguishing ischemic from nonischemic dilated cardiomyopathy. Glamann DB, Lange RA, Corbett JR, Hillis LD. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44520 |
Study title: Arch Mal Coeur Vaiss. 1987 Apr;80(4):470-82. [Current role of radionuclide imaging in pediatric cardiology] [Article in French] Brunotte F, Laurens MH, Marçon F, Cloez JL, Robert J, Pernot C. Arch Mal Coeur Vaiss. 1987 Apr;80(4):470-82. [Current role of radionuclide imaging in pediatric cardiology] [Article in French] Brunotte F, Laurens MH, Marçon F, Cloez JL, Robert J, Pernot C. |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44521 |
Study title: Arch Mal Coeur Vaiss. 1997 May;90(5):631-7. [Alteration of myocardial viability and systemic ventricular dysfunction after Senning procedure] [Article in French] Labbé L, Douard H, Barat JL, Broustet JP, Bordenave L, Ducassou D, Valli N, Jimenez M, BaArch Mal Coeur Vaiss. 1997 May;90(5):631-7. [Alteration of myocardial viability and systemic ventricular dysfunction after Senning procedure] [Article in French] Labbé L, Douard H, Barat JL, Broustet JP, Bordenave L, Ducassou D, Valli N, Jimenez M, Ba |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44522 |
Study title: Arch Mal Coeur Vaiss. 2003 May;96(5):507-10. [Abnormalities of myocardial perfusion in sickle cell disease in childhood: a study of myocardial scintigraphy] [Article in French] Acar P, Maunoury C, de Montalembert M, Dulac Y. Arch Mal Coeur Vaiss. 2003 May;96(5):507-10. [Abnormalities of myocardial perfusion in sickle cell disease in childhood: a study of myocardial scintigraphy] [Article in French] Acar P, Maunoury C, de Montalembert M, Dulac Y. |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44523 |
Study title: EVALUATE EFFICACY AND TOLERATION OF FASIGYN 500 MG IN SYMPTOMATIC INTESTINAL AMEBIASIS. |
Active substance: TINIDAZOLE |
Study summary document link (including results): TND-II-88-001 EMEA Pediatrics Web Synopsis.pdf |
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Document reference: 44773 |
Study title: THE TREATMENT OF T VAGINALIS INFECTIONS IN CHILDREN |
Active substance: TINIDAZOLE |
Study summary document link (including results): |
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Document reference: 44769 |
Study title: A multicentre placebo−controlled study in general practice to evaluate the efficacy and safety of tizanidine in acute low−back pain.A multicentre placebo−controlled study in general practice to evaluate the efficacy and safety of tizanidine in acute low−back pain. |
Active substance: TINZANIDINE |
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Document reference: 44796 |
Study title: Clin Nucl Med. 1994 Nov;19(11):975-8. Resting Tl-201 scintigraphy in the evaluation of coronary artery disease in children with Hurler syndrome. du Cret RP, Weinberg EJ, Jackson CA, Braunlin EA, Boudreau RJ, Kuni CC, Carpenter BM, Hunter DW, Krivit W, BClin Nucl Med. 1994 Nov;19(11):975-8. Resting Tl-201 scintigraphy in the evaluation of coronary artery disease in children with Hurler syndrome. du Cret RP, Weinberg EJ, Jackson CA, Braunlin EA, Boudreau RJ, Kuni CC, Carpenter BM, Hunter DW, Krivit W, B |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44552 |
Study title: Conjunctival provocation test comparing levocabastine with cromoglycate and placebo (9-17 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62434_Interventional_Levocabastine.xls |
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Document reference: 31095 |
Study title: Double-blind placebo-controlled evaluation of levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a Belgian multicentre study (5-64 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62489_Interventional_Levocabastine.xls |
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Document reference: 31085 |
Study title: Double-blind placebo-controlled evaluation of levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a Dutch multicentre study (9-52 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62500_Interventional_Levocabastine.xls |
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Document reference: 31086 |
Study title: J Clin Neurosci. 2002 Nov;9(6):653-8. Comparison of thallium-201 uptake and retention indices for evaluation of brain lesions with SPECT. Katano H, Karasawa K, Sugiyama N, Yamashita N, Ohkura A, Watanabe K, Kamiya K. J Clin Neurosci. 2002 Nov;9(6):653-8. Comparison of thallium-201 uptake and retention indices for evaluation of brain lesions with SPECT. Katano H, Karasawa K, Sugiyama N, Yamashita N, Ohkura A, Watanabe K, Kamiya K. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44602 |
Study title: J Clin Neurosci. 2005 Jan;12(1):27-31. Thallium-201 versus Tc99m-glucoheptonate SPECT for evaluation of recurrent brain tumours: a within-subject comparison with pathological correlation. Barai S, Rajkamal , Bandopadhayaya GP, Pant GS, Haloi AK, MalhotJ Clin Neurosci. 2005 Jan;12(1):27-31. Thallium-201 versus Tc99m-glucoheptonate SPECT for evaluation of recurrent brain tumours: a within-subject comparison with pathological correlation. Barai S, Rajkamal , Bandopadhayaya GP, Pant GS, Haloi AK, Malhot |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44603 |
Study title: J Clin Oncol. 1999 Feb;17(2):554-60. Value of combined approach with thallium-201 single-photon emission computed tomography and Epstein-Barr virus DNA polymerase chain reaction in CSF for the diagnosis of AIDS-related primary CNS lymphoma. Antinori A, J Clin Oncol. 1999 Feb;17(2):554-60. Value of combined approach with thallium-201 single-photon emission computed tomography and Epstein-Barr virus DNA polymerase chain reaction in CSF for the diagnosis of AIDS-related primary CNS lymphoma. Antinori A, |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44604 |
Study title: J Neurol Neurosurg Psychiatry. 1997 Nov;63(5):569-74. Evaluation of malignancy in ring enhancing brain lesions on CT by thallium-201 SPECT. Källén K, Heiling M, Andersson AM, Brun A, Holtås S, Ryding E, Rosén I. J Neurol Neurosurg Psychiatry. 1997 Nov;63(5):569-74. Evaluation of malignancy in ring enhancing brain lesions on CT by thallium-201 SPECT. Källén K, Heiling M, Andersson AM, Brun A, Holtås S, Ryding E, Rosén I. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44605 |
Study title: J Nucl Cardiol. 2002 Nov-Dec;9(6):632-7. Myocardial ischemia in Kawasaki disease: evaluation with dipyridamole stress technetium 99m tetrofosmin scintigraphy. Fukuda T, Ishibashi M, Yokoyama T, Otaki M, Shinohara T, Nakamura Y, Miyake T, Kudoh T, Oku H J Nucl Cardiol. 2002 Nov-Dec;9(6):632-7. Myocardial ischemia in Kawasaki disease: evaluation with dipyridamole stress technetium 99m tetrofosmin scintigraphy. Fukuda T, Ishibashi M, Yokoyama T, Otaki M, Shinohara T, Nakamura Y, Miyake T, Kudoh T, Oku H |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44606 |
Study title: Open-label evaluation of the pharmacokinetic profile of oral tramadol hydrochloride tablets in children and adolescents aged between seven to sixteen years - Multicenter - 2000 |
Active substance: TRAMADOL |
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Document reference: 45032 |
Study title: Jpn Heart J. 1993 Jan;34(1):51-61. Evaluation of myocardial damage in Duchenne's muscular dystrophy with thallium-201 myocardial SPECT. Tamura T, Shibuya N, Hashiba K, Oku Y, Mori H, Yano K. Jpn Heart J. 1993 Jan;34(1):51-61. Evaluation of myocardial damage in Duchenne's muscular dystrophy with thallium-201 myocardial SPECT. Tamura T, Shibuya N, Hashiba K, Oku Y, Mori H, Yano K. |
Active substance: THALLIUM 201T1 CHLORIDE |
Study summary document link (including results): |
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Document reference: 44638 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Traumeel S (drops) [AWB-AT] |
Active substance: Traumeel - Tropfen |
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Document reference: 40279 |
Study title: Bannikov, Mihail Y.; Vasilenko, Inna V.: Anwendung von homöopathischen Komplexmitteln in der Behandlungakuter kindlicher Speiseröhrenverätzungen. Biol Med 2000 (29):253-254 [IIT-publication] |
Active substance: Traumeel - Ampullen |
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Document reference: 40283 |
Study title: Double-blind, placebo controlled evaluation of levocabastine eyedrops in the treatment of seasonal allergic conjunctivitis |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD93245_Interventional_Levocabastine.xls |
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Document reference: 31065 |
Study title: Effect of a new selective H1 receptor antagonist (levocabastine) in a nasal and conjunctival provocation test (11-44 yrs) |
Active substance: LEVOCABASTINE |
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Document reference: 31074 |
Study title: Efficacia della levocabastina nei confronti dell'antazolina in giovani pazienti affetti da congiuntivite prima verile. Annali di Oftalmologia e Clinica Occulista 122(12), p.629-634, 1996Efficacia della levocabastina nei confronti dell'antazolina in giovani pazienti affetti da congiuntivite prima verile. Annali di Oftalmologia e Clinica Occulista 122(12), p.629-634, 1996 |
Active substance: LEVOCABASTINE |
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Document reference: 31129 |
Study title: Eosinophil cationic protein (ECP) and tryptase in the nasal lavage fluid (NLF) of children with grass pollen rhinitis: levocabastine effect. Allergy and Asthma Proceedings 19(2), p.75-80, 1998Eosinophil cationic protein (ECP) and tryptase in the nasal lavage fluid (NLF) of children with grass pollen rhinitis: levocabastine effect. Allergy and Asthma Proceedings 19(2), p.75-80, 1998 |
Active substance: LEVOCABASTINE |
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Document reference: 31120 |
Study title: J Nucl Med. 1981 Oct;22(10):849-55. Clinical evaluation of thallium-201 emission myocardial tomography using a rotating gamma camera: comparison with seven-pinhole tomography. Tamaki N, Mukai T, Ishii Y, Yonekura Y, Kambara H, Kawai C, Torizuka K. J Nucl Med. 1981 Oct;22(10):849-55. Clinical evaluation of thallium-201 emission myocardial tomography using a rotating gamma camera: comparison with seven-pinhole tomography. Tamaki N, Mukai T, Ishii Y, Yonekura Y, Kambara H, Kawai C, Torizuka K. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44607 |
Study title: J Nucl Med. 1990 May;31(5):567-72. Thallium-201 scintigraphy in bone sarcoma: comparison with gallium-67 and technetium-MDP in the evaluation of chemotherapeutic response. Ramanna L, Waxman A, Binney G, Waxman S, Mirra J, Rosen G. J Nucl Med. 1990 May;31(5):567-72. Thallium-201 scintigraphy in bone sarcoma: comparison with gallium-67 and technetium-MDP in the evaluation of chemotherapeutic response. Ramanna L, Waxman A, Binney G, Waxman S, Mirra J, Rosen G. |
Active substance: THALLIUM 201T1 CHLORIDE |
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Document reference: 44609 |
Study title: Treatment of the West syndrome with high-dose pyridoxal phosphate - Y. Ohtsuka et al. - 1987 (Brain Dev vol 9) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of the West syndrome with high-dose pyridoxal phosphate - Y. Ohtsuka et al. - 1987 (Brain Dev vol 9) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31501 |
Study title: EFFECT OF PIROXICAM ON POST OPERATIVE DENTAL PAIN, SWELLING AND TRISMUS FOLLOWING REMOVAL OF BILATERALLY IMPACKED THIRD MOLAR TEETH. |
Active substance: PIROXICAM |
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Document reference: 34476 |
Study title: Michelagnoli MP et al Ifosfamide/etoposide alternating with high-dose methotrexate: evaluation of a chemotherapy regimen for poor-risk osteosarcoma Br J Cancer. 1999 Mar;79(7-8):1174-8Michelagnoli MP et al Ifosfamide/etoposide alternating with high-dose methotrexate: evaluation of a chemotherapy regimen for poor-risk osteosarcoma Br J Cancer. 1999 Mar;79(7-8):1174-8 |
Active substance: MITOXANTRONE |
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Document reference: 32137 |
Study title: Miser JS et al Treatment of metastatic Ewing sarcoma/primitive neuroectodermal tumor of bone: evaluation of increasing the dose intensity of chemotherapy--a report from theChildren's Oncology Group Pediatr Blood Cancer. 2007 Dec;49(7):894-900Miser JS et al Treatment of metastatic Ewing sarcoma/primitive neuroectodermal tumor of bone: evaluation of increasing the dose intensity of chemotherapy--a report from theChildren's Oncology Group Pediatr Blood Cancer. 2007 Dec;49(7):894-900 |
Active substance: MITOXANTRONE |
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Document reference: 32107 |
Study title: Langner A. Comparison of the effectiveness of 5-Methoxypsoralen and 8-Methoxypsoralen in photochemotherapy (PUVA) Przegl Dermatol 1991; 21-25.Langner A. Comparison of the effectiveness of 5-Methoxypsoralen and 8-Methoxypsoralen in photochemotherapy (PUVA) Przegl Dermatol 1991; 21-25. |
Active substance: METHOZSALEN |
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Document reference: 31716 |
Study title: Metz D. [Photochemotherapy of psoriasis using 8-MOP and UVA. Results of interval treatment. Clinical experiences from 6 dermatology hospitals], Dermatol Monatsschr. 1980 Jun;166(6):415-7.Metz D. [Photochemotherapy of psoriasis using 8-MOP and UVA. Results of interval treatment. Clinical experiences from 6 dermatology hospitals], Dermatol Monatsschr. 1980 Jun;166(6):415-7. |
Active substance: METHOZSALEN |
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Document reference: 31714 |
Study title: Vogalene suppositoire enfant et nourisson-dossier pharmaceutique (dossier de validation du 09/01/87) - No author - No date |
Active substance: METOPIMAZINE |
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Document reference: 31963 |
Study title: A Safety, Tolerability and Pharmacokinetics Study of TOPROL XL® (metoprolol succinate) Extended-release Tablets (metoprolol CR/XL) in Hypertensive Pediatric Patients: A Multicenter, Open-Label Extension of Protocol 307A |
Active substance: METOPROLOL |
Study summary document link (including results): D4020C00001 CSR Synopsis.pdf |
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Document reference: 31965 |
Study title: Dose Ranging, Safety and Tolerability of TOPROL-XL® (metoprolol succinate) Extended-release Tablets (metoprolol CR/XL) in Hypertensive Pediatric Subjects: A Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Study. |
Active substance: METOPROLOL |
Study summary document link (including results): D4020C00033 CSR Synopsis.pdf |
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Document reference: 31966 |
Study title: Nathan PC et al Adjuvant chemotherapy for the treatment of advanced pediatric nonrhabdomyosarcomasoft tissue sarcoma: the National Cancer Institute experience Pediatr Blood Cancer. 2005 May;44(5):449-54Nathan PC et al Adjuvant chemotherapy for the treatment of advanced pediatric nonrhabdomyosarcomasoft tissue sarcoma: the National Cancer Institute experience Pediatr Blood Cancer. 2005 May;44(5):449-54 |
Active substance: MITOXANTRONE |
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Document reference: 32167 |
Study title: A double-blind comparison study of pivampicillin suspension and cefaclor suspension in the treatment of acute otitis media |
Active substance: PIVAMPICILLIN |
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Document reference: 46047 |
Study title: Absorption in children and Infants following oral administration of Pivampicillin; Part of SE/DK expert report. Prof. C simon (Kiel) |
Active substance: PIVAMPICILLIN |
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Document reference: 46048 |
Study title: Antibiotics in the treatment of gastroenteritis caused by enteropathgenic E. coliAntibiotics in the treatment of gastroenteritis caused by enteropathgenic E. coli |
Active substance: PIVAMPICILLIN |
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Document reference: 46050 |
Study title: Comparative efficacy of mecillinam, mecillinam/ amoxicillin and trimethoprim/ sulfamethazole for treatment of typhoid fever in childrenComparative efficacy of mecillinam, mecillinam/ amoxicillin and trimethoprim/ sulfamethazole for treatment of typhoid fever in children |
Active substance: PIVAMPICILLIN |
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Document reference: 46051 |
Study title: Comparative efficacy of pivmecillinam and cotrimoxazole in acute shigellosis in childrenComparative efficacy of pivmecillinam and cotrimoxazole in acute shigellosis in children |
Active substance: PIVAMPICILLIN |
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Document reference: 46052 |
Study title: Comparison of long-term, low dose pivmecillinam and nitrofurantoin in the control of recurrent urinary tract infection in childrenComparison of long-term, low dose pivmecillinam and nitrofurantoin in the control of recurrent urinary tract infection in children |
Active substance: PIVAMPICILLIN |
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Document reference: 46063 |
Study title: Comparison of pivmecillinam and nalidixic acid in the treatment of acute shigellosis in childrenComparison of pivmecillinam and nalidixic acid in the treatment of acute shigellosis in children |
Active substance: PIVAMPICILLIN |
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Document reference: 46062 |
Study title: Efficacy, pharmacology, and safety of amdinocillin in treatment of neonatesEfficacy, pharmacology, and safety of amdinocillin in treatment of neonates |
Active substance: PIVAMPICILLIN |
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Document reference: 46056 |
Study title: Long term, low dose treatment with pivmecillinam alone and in combination with pivampicillin in patients prone to recurrent bacteriuria; Barclay R.P.C. et al. 1982, Current medical research and opinion, 8: 82-88 LEO sponsored |
Active substance: PIVAMPICILLIN |
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Document reference: 46049 |
Study title: No study title available; Nineteen infants, between the age from 25 days and 2 years, having acute watery diarrhoea. |
Active substance: LOPERAMIDE |
Study summary document link (including results): LMD79083_Noninterventional_Loperamide hydrochloride.xls |
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Document reference: 31434 |
Study title: Effect size oh lithium, divalproex sodium and carbamazepine in children and adolescents with bipolar disorder. - Kowatch RA, Suppes T, Carmody TJ, et al. (2000) - (J AM Acad Child Adolesc Psychiatry 39:713-20)Effect size oh lithium, divalproex sodium and carbamazepine in children and adolescents with bipolar disorder. - Kowatch RA, Suppes T, Carmody TJ, et al. (2000) - (J AM Acad Child Adolesc Psychiatry 39:713-20) |
Active substance: LITHIUM |
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Document reference: 31306 |
Study title: Elevated thyrotropin in bipolar youths prescribed both lithium and divalproex sodium. - Gracious BL, Findling RL, Seman C et al (2004) - (J AM Acad Child Adolesc Psychiatry 43:215-20)Elevated thyrotropin in bipolar youths prescribed both lithium and divalproex sodium. - Gracious BL, Findling RL, Seman C et al (2004) - (J AM Acad Child Adolesc Psychiatry 43:215-20) |
Active substance: LITHIUM |
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Document reference: 31307 |
Study title: Publication: Giardiasis in infant and chidhood - Siavash Kavousi - 1979Publication: Giardiasis in infant and chidhood - Siavash Kavousi - 1979 |
Active substance: METRONIDAZOLE |
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Document reference: 31970 |
Study title: Electrophysiological clinical evaluation of mexiletine |
Active substance: MEXILETINE |
Study summary document link (including results): Mexiletine hydrochloride_U85-0802_synopsis.pdf |
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Document reference: 31979 |
Study title: Long term, low dose treatment with pivmecillinam alone and in combination with pivampicillin in patients prone to recurrent bacteriuriaLong term, low dose treatment with pivmecillinam alone and in combination with pivampicillin in patients prone to recurrent bacteriuria |
Active substance: PIVAMPICILLIN |
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Document reference: 46061 |
Study title: Mecillinam in cerebrospinal fluid in childrenMecillinam in cerebrospinal fluid in children |
Active substance: PIVAMPICILLIN |
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Document reference: 46057 |
Study title: Mecillinam in enteric feverMecillinam in enteric fever |
Active substance: PIVAMPICILLIN |
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Document reference: 46054 |
Study title: "The treatment of psoriasis capitis. Investigation of the efficacity of prednicarbate solution in comparison with commercially available, potent corticosteroid solution - M. Stander et al. - 1989 (Z. Hautkr vol 64) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-" "The treatment of psoriasis capitis. Investigation of the efficacity of prednicarbate solution in comparison with commercially available, potent corticosteroid solution - M. Stander et al. - 1989 (Z. Hautkr vol 64) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-" |
Active substance: PREDNICARBATE |
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Document reference: 34680 |
Study title: Open-label The study was conducted to evaluate the loperamide solutions since, it was found that the capsule form was not suitable for children on account of age. Children from 9 days to 2 years of age, hospitalised in a general paediatric assistance service for acute diarrhoea. |
Active substance: LOPERAMIDE |
Study summary document link (including results): LMD10146_Interventional_Loperamide Hydrochloride.xls |
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Document reference: 31428 |
Study title: A comparative study of the effectiveness of Pyrantel pamoate, mebendazol (Janssen) and generically equivalent mebendazole (Nordia) in intestinal helminthiasis in Papua New Guinea children. |
Active substance: MEBENDAZOLE |
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Document reference: 31548 |
Study title: Clinical evaluation of mebendazole in Taenia infestations. 1973 |
Active substance: MEBENDAZOLE |
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Document reference: 31541 |
Study title: SCH 29851: SINGLE DOSE BIOAVAILABILITY OF LORATADINE IN HEALTHY PEDIATRIC VOLUNTEERS |
Active substance: LORATADINE |
Study summary document link (including results): Claritine_Clarityn Syrup_Loratadine_C97033.pdf |
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Document reference: 31460 |
Study title: SCH 29851: Single-Dose Bioavailability of Loratadine Syrup in Pediatric Volunteers 6 Months to 2 Years of Age |
Active substance: LORATADINE |
Study summary document link (including results): Claritine_Clarityn Syrup_Loratadine_P00241.pdf |
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Document reference: 31462 |
Study title: A comparative field trial of five measles vaccines produced in human diploid cell, MRC-5 |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
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Document reference: 41234 |
Study title: A comparative field trial of five measles vaccines produced in human diploid cell, MRC-5 |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
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Document reference: 41370 |
Study title: A study comparing the association of yellow fever and measles vaccine and of both vaccine administered separately |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
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Document reference: 41244 |
Study title: A study comparing the association of yellow fever and measles vaccine and of both vaccine administered separately |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
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Document reference: 41380 |
Study title: Clinical study of a live attenuated measles vaccine, in susceptible aged 6 months to 4 years |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
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Document reference: 41231 |
Study title: Clinical study of a live attenuated measles vaccine, in susceptible aged 6 months to 4 years |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
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Document reference: 41367 |
Study title: Clinical study of the measles vaccine of Merieux Institute : rouvax - European multicenter study |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41248 |
Study title: Dose response study of live attenuated Schwarz strain measles vaccine Rouvax in young French children |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
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Document reference: 41232 |
Study title: Dose response study of live attenuated Schwarz strain measles vaccine Rouvax in young French children |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
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Document reference: 41368 |
Study title: Efficacity, safety and immunogenicity of two high-titer measles vaccines. A study in Niakhar, Senegal |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41243 |
Study title: Efficacity, safety and immunogenicity of two high-titer measles vaccines. A study in Niakhar, Senegal |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41379 |
Study title: European multicentre clinical study of the rouvax measles vaccine |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
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Document reference: 41245 |
Study title: European multicentre clinical study of the rouvax measles vaccine |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
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Document reference: 41381 |
Study title: Immunogenicity and reactogenicity study of Rouvax vaccine in differents age-group children in France |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
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Document reference: 41240 |
Study title: Siddiqui AH. Comparison of serum levels and clinical results of PUVA therapy with three different dosage forms of 8-methoxypsoralen, Arch Dermatol Res. 1984;276(5):343-5.Siddiqui AH. Comparison of serum levels and clinical results of PUVA therapy with three different dosage forms of 8-methoxypsoralen, Arch Dermatol Res. 1984;276(5):343-5. |
Active substance: METHOZSALEN |
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Document reference: 31719 |
Study title: Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198) for external eye infections- phase III open clinical trialClinical evaluation of Lomefloxacin ophthalmic solution (NY-198) for external eye infections- phase III open clinical trial |
Active substance: LOMEFLOXACIN |
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Document reference: 31352 |
Study title: Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198)Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198) |
Active substance: LOMEFLOXACIN |
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Document reference: 31351 |
Study title: Clinical evaluation of topical Lome-floxacin (NY-198) for external eye infection.Clinical evaluation of topical Lome-floxacin (NY-198) for external eye infection. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31347 |
Study title: J.C. Escher et al. Treatment of inflammatory bowel disease in childhood: Best available evidence. Inflammatory bowel disease 2003;9:34-58. J.C. Escher et al. Treatment of inflammatory bowel disease in childhood: Best available evidence. Inflammatory bowel disease 2003;9:34-58. |
Active substance: MESALAZINE |
Study summary document link (including results): |
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Document reference: 31640 |
Study title: Observational study of the efficacy and safety of Salofalk 500mg/1000mg Granu-Stix for the acute and maintenance of remission treatment of ulcerative colitis patients |
Active substance: MESALAZINE |
Study summary document link (including results): EUdraCT_reduced_datafields_paediatric data_Mesalazine_Salofalk granules_Dr Falk Pharma GmbH.xls |
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Document reference: 31627 |
Study title: A Double-Blind, Randomized Dose-Response Study of Losartan in Children With Hypertension |
Active substance: LOSARTAN |
Study summary document link (including results): |
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Document reference: 31470 |
Study title: An Open-Label Study to Investigate the Pharmacokinetics of Losartan in Hypertensive Children and Infants |
Active substance: LOSARTAN |
Study summary document link (including results): |
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Document reference: 31471 |
Study title: A Double-Blind, Randomized Dose-Response Study of Losartan in Children With Hypertension |
Active substance: LOSARTAN POTASSIUM |
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Document reference: 46656 |
Study title: An Open-Label Study to Investigate the Pharmacokinetics of Losartan in Hypertensive Children and Infants |
Active substance: LOSARTAN POTASSIUM |
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Document reference: 46657 |
Study title: A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Lovastatin in Adolescent Girls. |
Active substance: LOVASTATIN |
Study summary document link (including results): |
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Document reference: 31472 |
Study title: Prospective, multicenter, observational study to document therapeutic data in the use of Luffa compositum-Heel (tablets) and Luffa comp.-Heel (nose drops) in the treatment of hay fever [AWB-008] |
Active substance: Luffa comp.-Heel/ Luffa compositum-Heel - Tabletten/ Luffeel - Nasenspray |
Study summary document link (including results): |
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Document reference: 40050 |
Study title: Clinical safety and efficacy evaluation of oral lymecycline versus minocycline in the treatment of inflammatory acne - Mexico |
Active substance: LYMECYCLINE |
Study summary document link (including results): |
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Document reference: 31475 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Lymphomyosot (tablets) [AWB-027] |
Active substance: Lymphomyosot |
Study summary document link (including results): |
View full study record |
Document reference: 40053 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Lymphomyosot (ampoules) [AWB-AT] |
Active substance: Lymphomyosot - Ampullen |
Study summary document link (including results): |
View full study record |
Document reference: 40054 |
Study title: ND: 29874 AU: Azeka-E. IN: Dr. E. Azeka, Hospital das Clinicas, Medicine School, Universidade de Sao Paulo (FMUSP), Sao Paulo, SP. TI: The impact of L-carnitine on nutritional status in juvenile idiopathic dilated cardiomyopathy.; SO: Jornal de Pediatria {J-PEDIATR}, 2005, Vol/Iss/Pg. 81/5 (355-356), ISSN: 0021-7557ND: 29874 AU: Azeka-E. IN: Dr. E. Azeka, Hospital das Clinicas, Medicine School, Universidade de Sao Paulo (FMUSP), Sao Paulo, SP. TI: The impact of L-carnitine on nutritional status in juvenile idiopathic dilated cardiomyopathy.; SO: Jornal de Pediatria {J-PEDIATR}, 2005, Vol/Iss/Pg. 81/5 (355-356), ISSN: 0021-7557 |
Active substance: LEVOCARNITINE |
Study summary document link (including results): |
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Document reference: 31143 |
Study title: The role of L-carnitine in nutritional status and echocardiographic parameters in idiopathic dilated cardiomyopathy in children. Azevedo VM, Albanesi Filho FM, Santos MA, Castier MB, Cunha MO. J Pediatr (Rio J). 2005 Sep-Oct; 81(5): 368-72The role of L-carnitine in nutritional status and echocardiographic parameters in idiopathic dilated cardiomyopathy in children. Azevedo VM, Albanesi Filho FM, Santos MA, Castier MB, Cunha MO. J Pediatr (Rio J). 2005 Sep-Oct; 81(5): 368-72 |
Active substance: LEVOCARNITINE |
Study summary document link (including results): |
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Document reference: 31142 |
Study title: Anwendungsbeobachtung zur Therapie allergischer Erkrankungen mit Xusal Tropfen bei Kindern ab 2 Jahren. |
Active substance: LEVOCETIRIZINE |
Study summary document link (including results): A00315 - Levocetirizine - RRLE03E1601.pdf |
View full study record |
Document reference: 31149 |
Study title: Bioavailability of methylphenidate hydrochloride from a 20mg sustained release tablet in children (1980) |
Active substance: METHYLPHENIDATE |
Study summary document link (including results): |
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Document reference: 31727 |
Study title: A randomized, double-blind, placebo-controlled trial to measure the antibody response to immunisation with diphtheria-tetanus-pertussis-inactivated poliovirus-haemophilus influenzae b and hepatitis B vaccines using |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 14_DC-EMB-0002 CSR Synopsis.pdf |
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Document reference: 47244 |
Study title: A randomized, double-blind, placebo-controlled trial to measure the antibody response to immunization with measles-mumbs-rubella vaccines using EMLA patch for the reduction of pain associated with subcutaneous injection in twelve month old infants, 1998 |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 13_DC-EMB-0001 CSR Synopsis.pdf |
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Document reference: 47245 |
Study title: Analgesia for the surgical removal of molluscum contagiosum in children: a double-blind, placebo-controlled, time-repsonse study of EMLA(R) (lidocaine/prilocaine) cream. Astra Report 802-10 AC 082-1, February 05, 1990. |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 06_86EM25 CSR Synopsis.pdf |
View full study record |
Document reference: 47251 |
Study title: A clinical evaluation of UCB in paediatrics |
Active substance: MESNA |
Study summary document link (including results): DE75C051 - Mesna.pdf |
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Document reference: 31653 |
Study title: A Pilot Evaluation of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Memantine in Pediatric Patients with Attention-Deficit/Hyperactivity Disorder (ADHD) Combined Type |
Active substance: Memantine Hydrochloride |
Study summary document link (including results): |
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Document reference: 41492 |
Study title: Clinical observation and experience with memantine in the treatment of spastic movement disorders. |
Active substance: Memantine Hydrochloride |
Study summary document link (including results): |
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Document reference: 41487 |
Study title: Epidemic of meningococcal meningitis in Bamako, Mali: epidemiological features and analysis of vaccine efficacy. |
Active substance: Meningococcal Polysaccharide Vaccine (Strains A + C) |
Study summary document link (including results): |
View full study record |
Document reference: 41251 |
Study title: A controlled field trial of serogroup A meningococcal polysaccharide vaccine. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41269 |
Study title: A second controlled field trial of a serogroup A meningococcal polysaccharide vaccine in Alexandria. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41271 |
Study title: A serogroup A meningococcal polysaccharide vaccine: studies in the Sudan to combat cerebrospinal meningitidis caused by Neisseria meningitidis group A. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41270 |
Study title: Adverse events after polysaccharide meningococcal A & C vaccine. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41258 |
Study title: Adverse events temporally associated with meningoccal vaccines. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): link to document |
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Document reference: 41257 |
Study title: Assessment of the immunogenicity and safety of a meningococcal A/C diptheria conjugate vaccine administered in two-year old children in comparison with a licensed meningococcal A/C polysaccharide vaccine. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41268 |
Study title: Control of epidemic meningococcal meningitis by mass vaccination. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 47477 |
Study title: Control of serogroup C meningococcal meningitis by mass vaccination in Catalonia (Spain). |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41254 |
Study title: Controlled tests of anti-meningococcal polysaccharide A vaccine in the African Sahel area (upper Volta and Mali). |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
View full study record |
Document reference: 41273 |
Study title: Pharmacokinetic evaluation and ex vivo serum protein binding. levocetirizine dihydrochloride (ucb 28556). a non-controlled, pilot, multi-centric, open study of the efficacy and safety of levocetirizine dihydrochloride 5 mg/ml oral drops given 0.125 mg/kg b.i.d. during 90 days in the treatment of recurrent cough associated with other allergic symptoms, e.g. wheezing, in children aged 1-2 years. |
Active substance: LEVOCETIRIZINE |
Study summary document link (including results): ARVD04B1001 - Levocetirizine.pdf |
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Document reference: 31151 |
Study title: The early prevention of asthma in atopic children (EPAAC(TM)) study. a multi-country, double blind, placebo-controlled, randomized, parallel group trial: evaluation of the efficacy and safety of levocetirizine (5 mg/ml oral drops - 0.125 mg/kg b.w. b.i.d.) administered for 18 months in preventing the onset of asthma in 12 to 24 months old children who suffer from atopic dermatitis and are sensitized to grass pollen and / or house dust mite allergens. |
Active substance: LEVOCETIRIZINE |
Study summary document link (including results): |
View full study record |
Document reference: 31154 |
Study title: Sei-ichi Ishimoto, Department of Ophthalmology, Faculty of Medicine, Kyusyu University, Clinical evaluation of topical Lomefloxacin (NY-198) for external eye infection. No report date.Sei-ichi Ishimoto, Department of Ophthalmology, Faculty of Medicine, Kyusyu University, Clinical evaluation of topical Lomefloxacin (NY-198) for external eye infection. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31383 |
Study title: Astra Report A randomized, open label, comparative parallel group study to evaluate the efficacy and safety of EMLA® Cream and 1% Xylocaine® infiltration in males for relief of pain associated with the removal of genital warts by cryotherapy. |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 11_93-EML-18 CSR Synopsis.pdf |
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Document reference: 47247 |
Study title: Astra Report No. 802-10 AC 062-1 Local Anaesthesia with Emla Cream for Laser Treatment of Condylomata Acuminata in Women. A Double-blind Comparison with Placebo to Evaluate the Time of Onset and Duration of Anaesthesia of the Genital Mucosa. 86EM07 |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 10_86-EM07 CSR Synopsis.pdf |
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Document reference: 47248 |
Study title: Double-blind evaluation of a lidocaine-prilocaine cream (EMLA) for venous cannulation pain in children |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 31_83-P029 CSR Synopsis.pdf |
View full study record |
Document reference: 47229 |
Study title: "Reversed vVntilation Perfusion Mismatch Involving a pediatric Patient in Congestive Heart Failure - Evan Zucker, Sydney Heyman and Savas Ozdemir - The Journal of Nuclear Medicine Vol 38 - No 11- November 1997" "Reversed vVntilation Perfusion Mismatch Involving a pediatric Patient in Congestive Heart Failure - Evan Zucker, Sydney Heyman and Savas Ozdemir - The Journal of Nuclear Medicine Vol 38 - No 11- November 1997" |
Active substance: MILRINONE |
Study summary document link (including results): |
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Document reference: 32037 |
Study title: Serial blood lactate measurements predict early mortality following neonatal repair or palliation for complex congenital heart disease - Charpie JR et al. - 1999 (Circulation suppl 1, 1999, 100 (18) 1399)Serial blood lactate measurements predict early mortality following neonatal repair or palliation for complex congenital heart disease - Charpie JR et al. - 1999 (Circulation suppl 1, 1999, 100 (18) 1399) |
Active substance: MILRINONE |
Study summary document link (including results): |
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Document reference: 32034 |
Study title: Serial blood lactate measurements predict early outcome after neonatal repair or palliation for complex congenital heart disease - Charpie JR et al. - 2000 (J Thorac Cardiovasc Surg 2000, 120, 73-80)Serial blood lactate measurements predict early outcome after neonatal repair or palliation for complex congenital heart disease - Charpie JR et al. - 2000 (J Thorac Cardiovasc Surg 2000, 120, 73-80) |
Active substance: MILRINONE |
Study summary document link (including results): |
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Document reference: 32035 |
Study title: The effects of milrinone on platelets in patients undergoing cardiac surgery - Kikura M et al. - 1995 (Anest Analg 1995, 81, 44 -48)The effects of milrinone on platelets in patients undergoing cardiac surgery - Kikura M et al. - 1995 (Anest Analg 1995, 81, 44 -48) |
Active substance: MILRINONE |
Study summary document link (including results): |
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Document reference: 32036 |
Study title: The platelet function defect of cardiopulmonary bypass - Kestin AS et al. - 1993 (Blood, 1993, 82, 107-117)The platelet function defect of cardiopulmonary bypass - Kestin AS et al. - 1993 (Blood, 1993, 82, 107-117) |
Active substance: MILRINONE |
Study summary document link (including results): |
View full study record |
Document reference: 32038 |
Study title: Altomare M.,Bugnoni L.,Riva M. La Biochetasi nella terapia dell’emesi gravidica Eur.Rev.Med.Pharm.Sci.,6,573-576,1984Altomare M.,Bugnoni L.,Riva M. La Biochetasi nella terapia dell’emesi gravidica Eur.Rev.Med.Pharm.Sci.,6,573-576,1984 |
Active substance: MINERALS AND VITAMINS |
Study summary document link (including results): |
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Document reference: 32040 |
Study title: Febrile seizures after immunization with meningococcal A + C vaccine. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
View full study record |
Document reference: 41256 |
Study title: Propper L, Hrdlicka M, Bares M, Kajlikova M, Goetz M, Lorenc J, Koutek J. Ceska Slov Psychiatr 2000;96:376-80.Propper L, Hrdlicka M, Bares M, Kajlikova M, Goetz M, Lorenc J, Koutek J. Ceska Slov Psychiatr 2000;96:376-80. |
Active substance: MIANSERIN |
Study summary document link (including results): |
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Document reference: 31991 |
Study title: Vitamin B6, Magnesium and combined B6-Mg : therapeutic effects in childhood autism - J. Martineau et al. - 1985 (Biol. Psychiatry vol 20) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Vitamin B6, Magnesium and combined B6-Mg : therapeutic effects in childhood autism - J. Martineau et al. - 1985 (Biol. Psychiatry vol 20) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31502 |
Study title: Brief report : an open middle term study of combined vitamin B6 - Magnesium in a subgroup of autistic children selected on their sensitivity to this treatment - J. Martineau et al. - 1988 ( Journal of Autitism and Developmental disorders vol 18) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31505 |
Study title: Current perspectives on pyridoxin-dependant seizures - S.M Gospe - 1998 (J. Pediatr vol 132) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Current perspectives on pyridoxin-dependant seizures - S.M Gospe - 1998 (J. Pediatr vol 132) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31507 |
Study title: Efficacy of vitamin B6 and magnesium in the treatment of autism : a methodology review an summary of outcomes - S.I Pfeiffer et al. - 1995 (Journal of Autism and Developmental Disorders vol 25) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Convulsions hypomagnésemique chez le nouveau-né - Stern L, Harpur ER - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971 |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31506 |
Study title: Therapeutical effectiveness and safety of 2% mebendazole syrup In various helminthiases. 1975 |
Active substance: MEBENDAZOLE |
Study summary document link (including results): |
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Document reference: 31547 |
Study title: Bonati E.,Olivani P:F. Risultati preliminari sull’impiego nell’età pediatrica di un farmaco ad azione psicotropa Arch.Med.Int.,26(2),39,1974Bonati E.,Olivani P:F. Risultati preliminari sull’impiego nell’età pediatrica di un farmaco ad azione psicotropa Arch.Med.Int.,26(2),39,1974 |
Active substance: MINERALS AND VITAMINS |
Study summary document link (including results): |
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Document reference: 32048 |
Study title: Immunogenicity studies on thermostable Rouvax vaccine |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41241 |
Study title: Immunogenicity studies on thermostable Rouvax vaccine |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
View full study record |
Document reference: 41377 |
Study title: Immunogenicity trial of Edmonston-Zagreb, Schwarz and AIK-C strain measles vaccines given at different ages and at differents titers in Togolese children |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
View full study record |
Document reference: 41246 |
Study title: Immunogenicity trial of Edmonston-Zagreb, Schwarz and AIK-C strain measles vaccines given at different ages and at differents titers in Togolese children |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
View full study record |
Document reference: 41382 |
Study title: Immunogenicity trial of Rouvax vaccine with a new stabiliser in tunisian children |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41375 |
Study title: Persistence of antibodies five years after measles vaccination |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41237 |
Study title: Persistence of antibodies five years after measles vaccination |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41373 |
Study title: Randomized double blind, controlled trail on dose-Response of AIK-C strain measles vaccine among togolese children . |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41247 |
Study title: Randomized double blind, controlled trail on dose-Response of AIK-C strain measles vaccine among togolese children . |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41383 |
Study title: Serological response to measles vaccine (Schwartz strain) in relation to the age of the children, in low-income population at Rio de Janeiro |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41238 |
Study title: Immunogenicity and reactogenicity study of Rouvax vaccine in differents age-group children in France |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41376 |
Study title: Immunogenicity and safety of Rouvax vaccine in different age-group Thai children |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41378 |
Study title: Serological response to measles vaccine (Schwartz strain) in relation to the age of the children, in low-income population at Rio de Janeiro |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
View full study record |
Document reference: 41374 |
Study title: Study of measles vaccination in child health centres in Paris |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41233 |
Study title: Study of measles vaccination in child health centres in Paris |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41369 |
Study title: Study of the humoral response and persistence of antibody titer to measles vaccination in relation with the age at vaccination |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41236 |
Study title: Study of the humoral response and persistence of antibody titer to measles vaccination in relation with the age at vaccination |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
View full study record |
Document reference: 41372 |
Study title: Study with combenied meningococcal, measles and tetanus vaccine in Nigerian children |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41235 |
Study title: Study with combenied meningococcal, measles and tetanus vaccine in Nigerian children |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41371 |
Study title: |
Active substance: Live attenuated measles, mumps, rubella, varicella vaccine |
Study summary document link (including results): |
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Document reference: 47683 |
Study title: Etude des variations du Magnesium erythrocitaire et plasmatique dans les dystrophies muscularies - Astier-Dumas M et al - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971Etude des variations du Magnesium erythrocitaire et plasmatique dans les dystrophies muscularies - Astier-Dumas M et al - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971 |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31508 |
Study title: European Commission Scientific Committee on Food. Opinion of the Scientific Commitee on Food on the tolerable upper intake leval of vitamin B6 (http : // europa.eu.int/comm/food/fs/sc/scf/index en.htlm) - 11/2000 - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -European Commission Scientific Committee on Food. Opinion of the Scientific Commitee on Food on the tolerable upper intake leval of vitamin B6 (http : // europa.eu.int/comm/food/fs/sc/scf/index en.htlm) - 11/2000 - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31509 |
Study title: Mastrangelo et al. Critical observations on neuroblastoma treatment with 131-Imetaiodobenzylguanidine at diagnosisMedical and pediatric oncology (1993), 21(6), 411-5 |
Active substance: META-IODOBENZYLGUANIDINE |
Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc |
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Document reference: 48324 |
Study title: Stable disease and improved health-related quality of life (HRQoL) following fractionated low dose 131I-metaiodobenzylguanidine (MIBG) therapy in metastatic paediatric paraganglioma: observation on false "reverse" discordance during pre-therapy work up and its implication for patient selection for high dose targeted therapyBasu et al. |
Active substance: META-IODOBENZYLGUANIDINE |
Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc |
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Document reference: 48310 |
Study title: Treatment of advanced neuroblastoma with I-131 meta-iodobenzylguanidineCancer (1991), 67(4), 922-8 |
Active substance: META-IODOBENZYLGUANIDINE |
Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc |
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Document reference: 48315 |
Study title: "Corticosteroids improve survival of children with AIDS and Pneumocystis carinii pneumonia - Sleasman JW - 1993 (Am J Dis Child 147 30-34) - Publication in CER - Simons G - July 1997 -" Clinical Expert Report July 1997 |
Active substance: METHYLPREDNISOLONE |
Study summary document link (including results): |
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Document reference: 31922 |
Study title: Double-blind, randomized, reference-controlled, multicenter, parallelgroup study to compare the efficacy and safety of Advantan ointment once daily with Protopic 0.03% ointment twice daily over maximum 3 weeks in 250 children and adolescents with atopic dermatitis |
Active substance: METHYLPREDNISOLONE |
Study summary document link (including results): Bayer Intendis_Methylprednisolone Aceponate_308962_study_synopsis.pdf |
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Document reference: 47734 |
Study title: Study to evaluate the clinical efficacy and tolerability of mesalazine in microgranules in the treatment of active ulcerative colitis, mild to moderate, and in maintenance in childrenStudy to evaluate the clinical efficacy and tolerability of mesalazine in microgranules in the treatment of active ulcerative colitis, mild to moderate, and in maintenance in children |
Active substance: MESALAZINE |
Study summary document link (including results): |
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Document reference: 31629 |
Study title: A phase II, open, case-controlled clinical study to assess the immunogenicity, reactogenicity and safety of a 2nd dose of GlaxoSmithKline Biologicals’ measles-mumps-rubella-varicella (MeMuRu-OKA) vaccine given in healthy children of 5 to 6 years of age |
Active substance: Live attenuated measles, mumps, rubella, varicella vaccine |
Study summary document link (including results): |
View full study record |
Document reference: 47877 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Lymphomyosot (drops) [AWB-AT] |
Active substance: Lymphomyosot - Tropfen |
Study summary document link (including results): |
View full study record |
Document reference: 40062 |
Study title: Godovanetz Yu.D., et al: Effectiveness of antihomotoxic therapy in the correction of neurological and metabolical impairments in newborns suffered from perinatal hypoxic stress. Biological Therapy (Ukraine), 2004, 2: 16-23 and 3-4: 36-45 [IIT-publication |
Active substance: Lymphomyosot - Tropfen |
Study summary document link (including results): |
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Document reference: 40063 |
Study title: Venomenhal Bee/Wasp. Observational cohort study |
Active substance: Lyophilised bee venom/ Lyophilised wasp venom |
Study summary document link (including results): |
View full study record |
Document reference: 39789 |
Study title: Comparative study of an acellular (P.M.sv.) and a whole cell (Wellcome) Pertussis vaccines com bined with Diphtheria and Tetanus vaccines in healthy infants according to 2 schedules in the U.K. |
Active substance: Diphtheria, Tetanus, Acellular Pertussis and inactivated Poliomyelitis Vaccine, adsorbed. |
Study summary document link (including results): |
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Document reference: 41410 |
Study title: Van Hasselt et al. Pretreatment with [131I] metaiodobenzylguanidine and surgical resection of advanced neuroblastoma, European journal of pediatric surgery official journal of Austrian Association of Pediatric Surgery = Zeitschrift fur Kinderchirurgie (1996), 6(3), 155-8 |
Active substance: META-IODOBENZYLGUANIDINE |
Study summary document link (including results): 2011-09 GE response 131 Meta-lodobenzylguanidine.doc |
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Document reference: 48328 |
Study title: The prolongation of the EPAAC(TM) trial (early prevention of asthma in atopic children), a multi-country, double-blind, placebo controlled, follow-up trial with 3 parallel groups (lctz-lctz, lctz-plc and plc-plc): evaluating the long term efficacy and safety of levocetirizine (5 mg/ml oral drops - 0.125 mg/kg b.w. b.i.d.) administered for an additional 18-month period in preventing the onset of asthma in children coming from the epaactm trial (A00309). |
Active substance: LEVOCETIRIZINE |
Study summary document link (including results): ARVD02J2302 - Levocetirizine.pdf |
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Document reference: 31150 |
Study title: The prolongation of the EPAAC™ trial (Early Prevention of Asthma in Atopic Children), a multi-country, double-blind, placebo controlled, follow-up trial with 3 parallel groups (LCTZ-LCTZ, LCTZ-PLC and PLC-PLC) : Evaluating the long term efficacy and safety of levocetirizine (5 mg/mL oral drops - 0.125 mg/kg b.w. b.i.d.) administered for an additional 18-month period in preventing the onset of asthma in children coming from the EPAAC™ trial (A00309) |
Active substance: LEVOCETIRIZINE |
Study summary document link (including results): A00384 - Levocetirizine - RPCE04B0203.pdf |
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Document reference: 47307 |
Study title: EMLA cream 5% for removal of mollusca. A clinical study of plasma concentrations of lidocaine and prilocaine and analgesic effect in children. |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 19_86EM13 CSR Synopsis.pdf |
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Document reference: 47239 |
Study title: EMLA cream for the removal of mollusca contagiosa on patients with atopic dermatitis. |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 27_86-EM14 CSR Synopsis.pdf |
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Document reference: 47233 |
Study title: Evaluate the pain relieving effect of EMLA Cream in oriental infants and possible adverse reactions. |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 01_83-P013 CSR Synopsis.pdf |
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Document reference: 47223 |
Study title: Brief report : an open middle term study of combined vitamin B6 - Magnesium in a subgroup of autistic children selected on their sensitivity to this treatment - J. Martineau et al. - 1988 ( Journal of Autitism and Developmental disorders vol 18) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): Mg lactate_mg pidolate_pyridoxine chlorhydrate STUDY 246-6-004.xls |
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Document reference: 31504 |
Study title: Humoral antibody responses to a biannual multiantigen vaccination: report of a field trial on children in Sudan. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41262 |
Study title: Immunogenicity of meningococcal A + C vaccine in Naval recruits. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41264 |
Study title: Impact of a mass immunization campaign against serogroup C meningococcus in the Province of Quebec, Canada. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): link to document |
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Document reference: 41253 |
Study title: Incidence of reactions to meningococcal A + C vaccine among U. K. school children. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41255 |
Study title: Meningococcal C polysaccharide vaccine induces immunologic hyporesponsiveness in adults that is overcome by meningococcal C conjugate vaccine. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41266 |
Study title: Mucosal immune responses to meningococcal groupe C conjugate and group A and C polysaccharide vaccines in adolescents. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41267 |
Study title: Prevention of secondary cases of meningococcal disease in household contacts by vaccination. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): link to document |
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Document reference: 41274 |
Study title: Results of a vaccination campaign in Brazil (1974 - 1975) using the meningococcal polysaccharide A + C vaccine. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41272 |
Study title: Serogroups A and C meningococcal polysaccharide vaccine. Clinical expert report. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41260 |
Study title: Study with combined meningococcal vaccines. II. A combined meningococcal and tetanus vaccine. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41261 |
Study title: Targeted vaccination with meningococcal polysaccharide vaccine in one district of the Czech Republic. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): link to document |
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Document reference: 41252 |
Study title: The immunological responses observed in field studies in Africa with group A meningococcal vaccines |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41259 |
Study title: The persistence of antibodies induced by meningococcal polysaccharides of groups A and C in human volunteers. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41263 |
Study title: Tolerance and immunogenicity of a new combined meningococcal (A + C) - Yellow Fever vaccine. |
Active substance: Meningococcal polysaccharide vaccine (strains A+C) |
Study summary document link (including results): |
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Document reference: 41265 |
Study title: A Multicenter, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Levofloxacin in the Treatment of Children Who Have RecUlTent and/or Persistent Acute Otitis Media |
Active substance: Levofloxacin |
Study summary document link (including results): LO FBO-OTMD-002.pdf |
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Document reference: 45233 |
Study title: An Open-Label Single Oral Dose Study to Evaluate the Safety and Pharmacokinetics of Levofloxacin Suspension Formulation in Infants and Children (~ 16 Years of Age) |
Active substance: Levofloxacin |
Study summary document link (including results): LOFBO-PHI-l10.pdf |
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Document reference: 45235 |
Study title: An Open-Label Study of Levofloxacin to Evaluate Bacteriologic Outcome in the Treatment of Children Who are at Risk for Acute Otitis Media That is Difficult to Treat |
Active substance: Levofloxacin |
Study summary document link (including results): |
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Document reference: 45232 |
Study title: Yasyski Morikawa, Teruo Nishida and Toshifumi Otori, Department of Ophthalmology, Kinki University, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198). No report date.Yasyski Morikawa, Teruo Nishida and Toshifumi Otori, Department of Ophthalmology, Kinki University, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198). No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31371 |
Study title: Yasyski Morikawa, Teruo Nishida and Toshifumi Otori, Department of Ophthalmology, Kinki University, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198). No report date.Yasyski Morikawa, Teruo Nishida and Toshifumi Otori, Department of Ophthalmology, Kinki University, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198). No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31386 |
Study title: Evaluation of analgesic effect and tolerability of EMLA Cream 5% in the laser treatment of port wine stains. Multicentre, randomised, double-blind versus placebo. |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 28_EM 9301 CSR Synopsis.pdf |
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Document reference: 47232 |
Study title: Evaluation of Emla 5% Cream for Alleviation of Pain in Connection with Tetanus Vaccination in School Children. 83P027 |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 26_83-P027 CSR Synopsis.pdf |
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Document reference: 47234 |
Study title: Evaluation of the Safety of EMLA Cream 5% on Intact Skin of Full-term Neonates |
Active substance: LIDOCAINE AND PRILOCAINE |
Study summary document link (including results): 16_95EM24 CSR Synopsis.pdf |
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Document reference: 47242 |
Study title: Reflex increase in blood pressure during the intracoronary administration of adenosine in Man - Cox D et al. - 1989 ( J. Clin. Invest, 84, 592-596)Reflex increase in blood pressure during the intracoronary administration of adenosine in Man - Cox D et al. - 1989 ( J. Clin. Invest, 84, 592-596) |
Active substance: ADENOSINE |
Study summary document link (including results): |
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Document reference: 46303 |
Study title: The therapeutic value of levocabastine eye drops in the treatment of allergic conjunctivitis: a double, placebo-controlled dose-finding study (6-72 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62492_Interventional_Levocabastine.xls |
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Document reference: 31101 |
Study title: Lucas da Silva, P.S., et al., Procedural sedation for insertion of central venous catheters in children: comparison of midazolam/fentanyl with midazolam/ketamine. Paediatr Anaesth, 2007. 17(4): p. 358-63. 6. Lucas da Silva, P.S., et al., Procedural sedation for insertion of central venous catheters in children: comparison of midazolam/fentanyl with midazolam/ketamine. Paediatr Anaesth, 2007. 17(4): p. 358-63. 6. |
Active substance: MIDAZOLAM |
Study summary document link (including results): |
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Document reference: 32005 |
Study title: Extract of submission to the UK's Food Standards Agency - P. Holford et al. - 2003 (Journal of Orthomolecular Medicine vol 18) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Extract of submission to the UK's Food Standards Agency - P. Holford et al. - 2003 (Journal of Orthomolecular Medicine vol 18) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31510 |
Study title: Institute of Medicine (US). Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Food and Nutrition Board. Dietary Reference Intakes for folate, other B vitamins, and choline. - No author - 1999 (Washington DC : National Academy Press) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Institute of Medicine (US). Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Food and Nutrition Board. Dietary Reference Intakes for folate, other B vitamins, and choline. - No author - 1999 (Washington DC : National Academy Press) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised dur... |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31511 |
Study title: MAGNE B6 - solution buvable - Rapport d'expertise clinique complémentaireMAGNE B6 - solution buvable - Rapport d'expertise clinique complémentaire - Dr Ch. BLATRIX 11.04.72 |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): Magnesium lactate, pyridoxine chlorhydrate STUDY 246.6.004.xls |
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Document reference: 31512 |
Study title: Jullien V, Urien S, Hirt D, Delaugerre C, Rey E, Teglas JP, Vaz P, Rouzioux C, Chaix ML, Macassa E, Firtion G, Pons G, Blanche S, Tréluyer JM. Population analysis of weight-, age-, and sex-related differences in the pharmacokinetics of lopinavir in children from birth to 18 years.Antimicrob Agents Chemother. 2006; Nov;50(11):3548-55. Epub 2006 Aug 28. |
Active substance: lopinavir / ritonavir |
Study summary document link (including results): |
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Document reference: 21187 |
Study title: Larrú B, Resino S, Bellón JM, de José MI, Fortuny C, Navarro ML, Gurbindo MD, Ramos JT, Soler P, Léon JA, Asensi M, Mellado MJ, Muñoz-Fernández MA. Long-term response to highly active antiretroviral therapy with lopinavir/ritonavir in pre-treated vertically HIV-infected children.Larrú B, Resino S, Bellón JM, de José MI, Fortuny C, Navarro ML, Gurbindo MD, Ramos JT, Soler P, Léon JA, Asensi M, Mellado MJ, Muñoz-Fernández MA. Long-term response to highly active antiretroviral therapy with lopinavir/ritonavir in pre-treated vertically HIV-infected children. |
Active substance: lopinavir / ritonavir |
Study summary document link (including results): |
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Document reference: 41528 |
Study title: An evaluation of antiemetic agents in the control of vomiting in children. |
Active substance: MECLOZINE |
Study summary document link (including results): DE76M282P.pdf |
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Document reference: 31563 |
Study title: Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP150CI Users and Non Hormonal Contraceptive Users |
Active substance: MEDROXYPROGESTERONE ACETATE |
Study summary document link (including results): A6791022 PhRMA Web Synopsis.pdf |
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Document reference: 48025 |
Study title: Therapeutic value of levocabastine eye drops in the treatment of seasonal allergic conjunctivitis: a double-blind comparison with sodium cromoglycate (9-46 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD56650_Interventional_Levocabastine.xls |
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Document reference: 31109 |
Study title: Therapeutic value of levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a double-blind comparison with sodium cromoglycate and placebo (9-52 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62487_Interventional_Levocabastine.xls |
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Document reference: 31079 |
Study title: Therapeutic value of levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a double-blind comparison with placebo (12-81 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62507_Interventional_Levocabastine.xls |
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Document reference: 31084 |
Study title: Therapeutic value of levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a double blind placebo-controlled study (7-43 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62503_Interventional_Levocabastine.xls |
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Document reference: 31088 |
Study title: A phase III, open, randomised, controlled multicentre study to evaluate the immunogenicity and safety of one dose of GlaxoSmithKline Biologicals’ combined measles-mumps-rubella-varicella vaccine (MeMuRu- OKA) given to healthy children 4 to 6 years of age previously primed with one dose of measles-mumpsrubella vaccine (either Priorix™ or M-M-R II™) in their second year of life and presumed seronegative for varicella. |
Active substance: Live attenuated measles, mumps, rubella, varicella vaccine |
Study summary document link (including results): |
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Document reference: 47878 |
Study title: A phase III, open, randomized, controlled study to evaluate the immunogenicity and safety of one dose of GlaxoSmithKline Biologicals’ measles-mumps-rubella-varicella vaccine (MeMuRu-OKA) given to healthy children of 4 to 6 years of age previously primed with one dose of measles-mumps-rubella vaccine (GlaxoSmithKline Biologicals’ PriorixÔ or Merck & Co.’s M-M-R IIÔ) |
Active substance: Live attenuated measles, mumps, rubella, varicella vaccine |
Study summary document link (including results): |
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Document reference: 47876 |
Study title: Assessment of the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ live attenuated Measles (Schwarz strain) - Mumps (RIT 4385 strain) - Rubella (RA 27/3 strain) - Varicella (Oka-strain) vaccine. An open clinical study in healthy 12 to 24 month old children. |
Active substance: Live attenuated measles, mumps, rubella, varicella vaccine |
Study summary document link (including results): |
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Document reference: 47879 |
Study title: Assessment of the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ live attenuated Measles (Schwarz strain) - Mumps (RIT 4385 strain) - Rubella (RA 27/3 strain) - Varicella (Oka-strain) vaccine. An open clinical study in healthy 12 to 24 month old children. |
Active substance: Live attenuated measles, mumps, rubella, varicella vaccine |
Study summary document link (including results): |
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Document reference: 47880 |
Study title: A controlled clinical study to assess the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ varicella vaccine in children aged between 1 and 12 years with a known history of neurodermatitis. |
Active substance: Live attenuated varicella vaccine (OKA strain) |
Study summary document link (including results): |
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Document reference: 47335 |
Study title: Assessment of the immunogenicity and reactogenicity of SmithKline Beecham Biologicals’ live attenuated varicella vaccine (Oka-strain) when administered at the same time as routine MMR (measles, mumps, rubella) vaccine but at different injection sites. An open clinical study in healthy 15- to 18-month-old children. |
Active substance: Live attenuated varicella vaccine (OKA strain) |
Study summary document link (including results): |
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Document reference: 47336 |
Study title: A double-blind, randomised, controlled multi-centre safety study of a refrigerator-stable formulation of VARIVAX® in healthy 12 to 15 month-old children. |
Active substance: Live attenuated varicella virus [Oka/ Merck strain] |
Study summary document link (including results): |
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Document reference: 47287 |
Study title: Use of Oka/Merck Varicella Vaccine in Children With Acute Lymphocytic Leukemia in Remission |
Active substance: Live attenuated varicella virus [Oka/ Merck strain] |
Study summary document link (including results): |
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Document reference: 47286 |
Study title: Clinical and immunological evaluation of the live attenuated RA27/3 rubella vaccine in seronegative children and adults in Switzerland |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
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Document reference: 41359 |
Study title: Clinical and immunological study on RA27/3 and cendehill strains of rubella vaccines during a vaccination campaign in Brittany and Mayenne in France |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
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Document reference: 41361 |
Study title: Clinical and serological evaluation of the live attenuated RA27/3 strain rubella vaccine in a population of susceptible children in France |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
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Document reference: 41363 |
Study title: Clinical evaluation of the live attenuated rubella vaccine, RA27/3 on seronegative children in Dakar (Senegal) |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
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Document reference: 41358 |
Study title: Clinical study of the vaccine against rubella rudivax Italy stydy |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
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Document reference: 41366 |
Study title: Comparative study of 3 different strains of rubella vaccines |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
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Document reference: 41360 |
Study title: Evaluation of the side effects occuring with two RA27/3 strains of rubella vaccine in a population of schoolgirl |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
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Document reference: 41365 |
Study title: Evaluation of the side effects occuring with two RA27/3 strains of rubella vaccine in a population of schoolgirl |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
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Document reference: 41457 |
Study title: Randomized, controlled trial of high-dose intravenous pyridoxine in the treatment of recurrent seizures in children - F.Y Jiao et al. - 1997 (Pediatric Neurology vol 17) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Randomized, controlled trial of high-dose intravenous pyridoxine in the treatment of recurrent seizures in children - F.Y Jiao et al. - 1997 (Pediatric Neurology vol 17) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31513 |
Study title: Clinical experience and results of treatment with suprofen in pediatrics - Giovannini M. et al. - 1986 (Arzneim.-Forsch/Drug Res.36(I).Nr.6) |
Active substance: METAMIZOLE |
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Document reference: 31692 |
Study title: Pyridoxine in atopic dermatitis - D.C Mabin et al. - 1995 (British Journal of Dermatology vol 133) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Pyridoxine in atopic dermatitis - D.C Mabin et al. - 1995 (British Journal of Dermatology vol 133) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31490 |
Study title: Pyridoxine treatment in a subgroup of children with pervasive developmental disorders - S. Kuriyama et al. - 2002 (Developmental Medicine and Child Neurology vol 44) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Pyridoxine treatment in a subgroup of children with pervasive developmental disorders - S. Kuriyama et al. - 2002 (Developmental Medicine and Child Neurology vol 44) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31491 |
Study title: Randomized, controlled trial of high-dose intravenous pyridoxine in the treatment of recurrent seizures in children - F.Y Jiao et al. - 1997 (Pediatric Neurology vol 17) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Randomized, controlled trial of high-dose intravenous pyridoxine in the treatment of recurrent seizures in children - F.Y Jiao et al. - 1997 (Pediatric Neurology vol 17) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31492 |
Study title: Rapport d'expertise clinique complémentaire sur le MAGNE B6 Solution buvable. - Blatrix Ch.- 11/04/1972Rapport d'expertise clinique complémentaire sur le MAGNE B6 Solution buvable. - Blatrix Ch.- 11/04/1972 |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
View full study record |
Document reference: 31493 |
Study title: Evaluation of the side effects occuring with two RA27/3 strains of rubella vaccine in a population of schoolgirls |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
View full study record |
Document reference: 47475 |
Study title: Evaluation study of the side effects occumng after two RA27/3 strains of rubella vaccines in a population of schoolgirls. |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
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Document reference: 47476 |
Study title: Rubella vaccination in school Children |
Active substance: LIVE RUBELLA VACCINE (RA 27/3-M STRAIN) |
Study summary document link (including results): |
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Document reference: 47474 |
Study title: Current perspectives on pyridoxin-dependant seizures - S.M Gospe - 1998 (J. Pediatr vol 132) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Current perspectives on pyridoxin-dependant seizures - S.M Gospe - 1998 (J. Pediatr vol 132) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31483 |
Study title: Efficacy of vitamin B6 and magnesium in the treatment of autism : a methodology review an summary of outcomes - S.I Pfeiffer et al. - 1995 (Journal of Autism and Developmental Disorders vol 25) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Efficacy of vitamin B6 and magnesium in the treatment of autism : a methodology review an summary of outcomes - S.I Pfeiffer et al. - 1995 (Journal of Autism and Developmental Disorders vol 25) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31484 |
Study title: El Bromhidrato de Glutamato de Magnesio Y Gaba como Tratamineto de la ansiedadZamora L Perez Valera |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): A-ZAMORA_L.PEREZ VALERA .pdf |
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Document reference: 48080 |
Study title: Electrophysiological effects of fenfluramine or combined vitamin B6 and magnesium on children with autistic behaviour - J. Martineau et al. - 1989 (Developmental Medicine and Child Neurology vol 31) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Electrophysiological effects of fenfluramine or combined vitamin B6 and magnesium on children with autistic behaviour - J. Martineau et al. - 1989 (Developmental Medicine and Child Neurology vol 31) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
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Document reference: 31485 |
Study title: Etude des variations du Magnesium erythrocitaire et plasmatique dans les dystrophies muscularies - Astier-Dumas M et al - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971Etude des variations du Magnesium erythrocitaire et plasmatique dans les dystrophies muscularies - Astier-Dumas M et al - 1971 - 1st International Symposium on Magnesium Deficit in Human Pathology -, Vittel, 1971 |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31486 |
Study title: A four-weeks evaluation of HOE777 fatty ointment 0,25%in young patients with severe atopic dermatitis of long duration - G. Rajka - 1987 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - A four-weeks evaluation of HOE777 fatty ointment 0,25%in young patients with severe atopic dermatitis of long duration - G. Rajka - 1987 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - |
Active substance: LEVONORGESTREL |
Study summary document link (including results): |
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Document reference: 31168 |
Study title: Patten, B. M. and Zeller, R. S. Clinical trials of vasoactive and antiserotonin drugs in Duchenne muscular dystrophy Ann.Clin.Res 1983;15:164-166.Patten, B. M. and Zeller, R. S. Clinical trials of vasoactive and antiserotonin drugs in Duchenne muscular dystrophy Ann.Clin.Res 1983;15:164-166. |
Active substance: METHYLSERGIDE |
Study summary document link (including results): |
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Document reference: 31958 |
Study title: Alizaprida, nuevo antiemetico en pediatria. Evaluacion clinica comparativa a metoclopramida STUDY 89-00616- ES-00 |
Active substance: METOCLOPRAMIDE |
Study summary document link (including results): Metoclopramide STUDY 89-00616-ES-00.xls |
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Document reference: 47988 |
Study title: Etude comparative Alizapride/Metoclopramide (forme gouttes buvables). Prevention et traitement des nausees et vomissements provoques par Ia chimiotherapie antineoplasique chez le nourrisson et l'enfant. |
Active substance: METOCLOPRAMIDE |
Study summary document link (including results): Metoclopramide STUDY 1813D635.xls |
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Document reference: 47991 |
Study title: Drugdex Evaluations: Liothyronine. Micro Medex Health Care Series Volume 99 (1999) |
Active substance: LIOTHYRONINE |
Study summary document link (including results): |
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Document reference: 31282 |
Study title: A single-centre, randomised, evaluator-blinded parallel-group study to compare the efficacy and safety of Oilatum Plus (antiseptic oil-based additive) and Q.V.Bath Oil (non antiseptic oil-based bath additive) in the treatment of atopic eczema. |
Active substance: LIQUID PARAFFIN |
Study summary document link (including results): |
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Document reference: 31283 |
Study title: European Commission Scientific Committee on Food. Opinion of the Scientific Commitee on Food on the tolerable upper intake leval of vitamin B6 (http : // europa.eu.int/comm/food/fs/sc/scf/index en.htlm) - 11/2000 - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31481 |
Study title: A double blind study comparing the local anaesthetic efficacy of 3 per cent Mepivacaine containing a vasoconstrictor. Aronson, M et al, J. Dent. Assoc. S. Afr. 1991A double blind study comparing the local anaesthetic efficacy of 3 per cent Mepivacaine containing a vasoconstrictor. Aronson, M et al, J. Dent. Assoc. S. Afr. 1991 |
Active substance: MEPIVACAINE |
Study summary document link (including results): |
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Document reference: 31608 |
Study title: Bilateral versus unilateral mandibular block anesthesia in a pediatric population. College, C. et al., Pediatr Dent. 2000Bilateral versus unilateral mandibular block anesthesia in a pediatric population. College, C. et al., Pediatr Dent. 2000 |
Active substance: MEPIVACAINE |
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Document reference: 31607 |
Study title: Clinical evaluation of mepivacaine and lidocaine; Bradley, D.j. et al, Aust Dent. J. 1969Clinical evaluation of mepivacaine and lidocaine; Bradley, D.j. et al, Aust Dent. J. 1969 |
Active substance: MEPIVACAINE |
Study summary document link (including results): |
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Document reference: 31609 |
Study title: Garofalo, Salvatore; Briganti, Vito; Cavallaro, Sebastiano; Pepe, Ernesto; Prete, Marina; Suteu, Liana; Tavormino, Paolo: Nickel Gluconate - Mercurius Heel - Potentised Swine Organ Preparations. International Journal of Pediatric Otorhinolaryngology 2007 |
Active substance: Mercurius-Heel S |
Study summary document link (including results): |
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Document reference: 40068 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Mercurius-Heel S (tablets) [AWB-AT] |
Active substance: Mercurius-Heel S |
Study summary document link (including results): |
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Document reference: 40070 |
Study title: Evaluating the efficacy of EMLA topical anesthetic in sealant placement with rubber dam. |
Active substance: LIDOCAINE |
Study summary document link (including results): |
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Document reference: 31223 |
Study title: Evaluation of the safety profile and clinical effectiveness of oral tramadol hydrochloride tablets for the treatment of postsurgical pain in children and adolescents aged seven to sixteen years (RWJ-26898-002) (protocol TRAM-PEDS-005; Phase 2) |
Active substance: LIDOCAINE |
Study summary document link (including results): |
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Document reference: 31227 |
Study title: Evaluation of three topical anaesthetic agents against pain: a clinical study. |
Active substance: LIDOCAINE |
Study summary document link (including results): |
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Document reference: 31219 |
Study title: Four types of topical anaesthetic agents: evaluation of clinical effectiveness. |
Active substance: LIDOCAINE |
Study summary document link (including results): |
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Document reference: 31220 |
Study title: Chapoy P, Louchet E (1983) Treatment of acute infant diarrhea: Advantages of loperamide. Med Chir Dig 1983; 12: 619–622Chapoy P, Louchet E (1983) Treatment of acute infant diarrhea: Advantages of loperamide. Med Chir Dig 1983; 12: 619–622 |
Active substance: LOPERAMIDE |
Study summary document link (including results): |
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Document reference: 31426 |
Study title: Drugdex Evaluations: Liothyronine. Micro Medex Health Care Series Volume 99 (1999)Drugdex Evaluations: Liothyronine. Micro Medex Health Care Series Volume 99 (1999) |
Active substance: LIQUID PARAFFIN |
Study summary document link (including results): |
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Document reference: 31285 |
Study title: Multicentre open clinical trial, in parallel groups, on the value of Oleatum emollient oil in the treatment of atopic eczema with topical corticosteroid therapy (Betamethasone-17-Valerate). |
Active substance: LIQUID PARAFFIN |
Study summary document link (including results): Article 45_Ref_C0474_Final For Submission_27 Oct 2011.xlsx |
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Document reference: 31286 |
Study title: A Double Blind Randomized Dose Response Study of Lisinopril in Children with Hypertension. (Protocol 115) and An Open Two Period Crossover Study to Determine the Relative Bioavailability of Lisinopril Suspension |
Active substance: LISINOPRIL |
Study summary document link (including results): |
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Document reference: 31291 |
Study title: A Double Blind Randomized Dose Response Study of Lisinopril in Children with Hypertension. |
Active substance: LISINOPRIL |
Study summary document link (including results): US No. 115_116 CSR Synopsis.pdf |
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Document reference: 31290 |
Study title: A multicenter, open-label, single-dose study to investigate the phamacokinetics of lisinopril in hypertensive children and infants. |
Active substance: LISINOPRIL |
Study summary document link (including results): US No. 114_117 CSR Synopsis.pdf |
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Document reference: 31296 |
Study title: An Open Two Period Crossover Study to Determine the Relative Bioavailability of Lisinopril Suspension. |
Active substance: LISINOPRIL |
Study summary document link (including results): |
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Document reference: 31295 |
Study title: An open two period crossover study to determine the relative bioavailability of lisinopril suspension (20 mg and marketed 20 mg tablets) |
Active substance: LISINOPRIL |
Study summary document link (including results): |
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Document reference: 31293 |
Study title: MRL Clinical Study Report: An Open, Two-Period Crossover Study to Determine the Relative Bioavailability of Lisinopril Suspension 20 mg and Marketed PRINIVIL™ 20-mg Tablets (Protocol 037). |
Active substance: LISINOPRIL |
Study summary document link (including results): |
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Document reference: 31288 |
Study title: Lopinavir/ritonavir once-daily in HIV-1 infected children: A pharmacokinetic and dose finding study. Published as Verweel G, Burger DM, Sheehan NL, Bergshoeff AS, Warris A, van der Knaap LC,Driessen G, de Groot R, Hartwig NG. Plasma concentrations of the HIV-protease inhibitor lopinavir are suboptimal in children aged 2 years and below. Antivir Ther. 2007;12(4):453-8. Lopinavir/ritonavir once-daily in HIV-1 infected children: A pharmacokinetic and dose finding study. Published as Verweel G, Burger DM, Sheehan NL, Bergshoeff AS, Warris A, van der Knaap LC,Driessen G, de Groot R, Hartwig NG. Plasma concentrations of the HIV-protease inhibitor lopinavir are suboptimal in children aged 2 years and below. Antivir Ther. 2007;12(4):453-8. |
Active substance: lopinavir / ritonavir |
Study summary document link (including results): |
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Document reference: 41521 |
Study title: Therapeutic value of levocabastine nasal spray in the treatment of seasonal allergic rhinitis: a double-blind comparison with sodium cromoglycate (6-39 yrs) |
Active substance: LEVOCABASTINE |
Study summary document link (including results): LMD62504_Interventional_Levocabastine.xls |
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Document reference: 31092 |
Study title: ND: 20138 AU: Winter-S, Jue-K, Prochazka-J, Francis-P, Hamilton-W, Linn-L, Helton- E. IN: Genetics/Metabolism, Valley Children's Hospital, 3151 North Millbrook, Fresno, CA 93703, United States. TI: The role of L-carnitine in pediatric cardiomyopathy.; SO: J-CHILD-NEUROL, 1995, VOL/ISS/PG. 10/SUPPL. 2 (2S45-2S51)ND: 20138 AU: Winter-S, Jue-K, Prochazka-J, Francis-P, Hamilton-W, Linn-L, Helton- E. IN: Genetics/Metabolism, Valley Children's Hospital, 3151 North Millbrook, Fresno, CA 93703, United States. TI: The role of L-carnitine in pediatric cardiomyopathy.; SO: J-CHILD-NEUROL, 1995, VOL/ISS/PG. 10/SUPPL. 2 (2S45-2S51) |
Active substance: LEVOCARNITINE |
Study summary document link (including results): |
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Document reference: 31146 |
Study title: ND: 27179 AU: BOUISSOU F, FABRE C, REMESY M, MESTERY D,YUNG M, CABAL G, PIQUEMAL J, MARMIN G, BOESEN G, FOURES M F, BARTHE PH. IN: NEPHROLOGIE PEDIATRIQUE, HOPITAL DES ENFANTS, TOULOUSE, FRANCE. TI: CARNITINE SUPPLEMENTATION IN HEMODIALYSED CHILDREN: EFFECTS ON HEMATOLOGICAL FINDINGS, LIPID PROFILE AND MUSCLES. UROPEAN SOCIETY FOR PAEDIATRIC NEPHROLOGY; SO: 33RD ANNUAL MEETING OF THE EUROPEAN SOCIETY FOR PAEDIATRIC NEPHROLOGY, PRAGUE, CZECH REPUBLIC, SEPTEMBER 2-5, 1999 SPONSORED BY: EUROPEAN SOCIETY FORPAEDIATRIC NEPHROLOGY. PEDIATRIC-NEPHROLOGY, SEPT., 1999, VOL. 13, NO. 7, C82;REUNION ANNUELLE NOVEMBER 1998, LUXEMBOURGND: 27179 AU: BOUISSOU F, FABRE C, REMESY M, MESTERY D,YUNG M, CABAL G, PIQUEMAL J, MARMIN G, BOESEN G, FOURES M F, BARTHE PH. IN: NEPHROLOGIE PEDIATRIQUE, HOPITAL DES ... |
Active substance: LEVOCARNITINE |
Study summary document link (including results): |
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Document reference: 31145 |
Study title: Studio comparativo tra miocamicina ed eritromicina nell'erradicazione di streptococco B-emolitico di Gruppo a ed influenza di miocamicina sulla fagocitosi dei polimorfonucleati verso streptococco autologo - M. Borzani, F. Varotto, L.Garlaschi, et al. - Riv. Inf. Ped. 1989, 1, 29-35 |
Active substance: MIDECAMYCIN |
Study summary document link (including results): |
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Document reference: 32014 |
Study title: Effect of milrinone on postbypass pulmonary hypertension in children after tetralogy of Fallot repair - Chu CC. et al. - No date (Clin Med J. 200, 63, 294-300)Effect of milrinone on postbypass pulmonary hypertension in children after tetralogy of Fallot repair - Chu CC. et al. - No date (Clin Med J. 200, 63, 294-300) |
Active substance: MILRINONE |
Study summary document link (including results): |
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Document reference: 32021 |
Study title: Chavarria AP, et al. Control of pediatric diarrhea. Adv Ther 1984 1: 115–119Chavarria AP, et al. Control of pediatric diarrhea. Adv Ther 1984 1: 115–119 |
Active substance: LOPERAMIDE |
Study summary document link (including results): |
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Document reference: 31444 |
Study title: Cornett JWD, et al. Double-Blind Comparative Evaluation of Loperamide versus Diphenoxylate with Atropine in Acute Diarrhea. Curr Ther Res 1977; 21: 629-37Cornett JWD, et al. Double-Blind Comparative Evaluation of Loperamide versus Diphenoxylate with Atropine in Acute Diarrhea. Curr Ther Res 1977; 21: 629-37 |
Active substance: LOPERAMIDE |
Study summary document link (including results): |
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Document reference: 31429 |
Study title: Review article : High-dose vitamin B6 treatment in West syndrome - Y. Toribe - 2001 (Brain and Development vol 23) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Review article : High-dose vitamin B6 treatment in West syndrome - Y. Toribe - 2001 (Brain and Development vol 23) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31516 |
Study title: Treatment of infantile spasms with high-dosage vitamin B6 - J. Pietz et al. - 1993 (Epilepsia vol 34) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of infantile spasms with high-dosage vitamin B6 - J. Pietz et al. - 1993 (Epilepsia vol 34) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31519 |
Study title: Ramos JT, De José MI, Dueñas J, Fortuny C, González-Montero R, Mellado MJ, Mur A, Navarro M, Otero C, Pocheville I, Muñoz-Fernández MA, Cabrero E; Spanish Collaborative Group on HIV Infection in Children. Safety and antiviral response at 12 months of lopinavir/ritonavir therapy in human immunodeficiency virus-1-infected children experienced with three classes of antiretrovirals. Pediatr Infect Dis J. 2005 Oct;24(10):867-73Ramos JT, De José MI, Dueñas J, Fortuny C, González-Montero R, Mellado MJ, Mur A, Navarro M, Otero C, Pocheville I, Muñoz-Fernández MA, Cabrero E; Spanish Collaborative Group on HIV Infection in Children. Safety and antiviral response at 12 months of lopinavir/ritonavir therapy in human immunodeficiency virus-1-infected children experienced with three classes of anti... |
Active substance: lopinavir / ritonavir |
Study summary document link (including results): |
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Document reference: 41531 |
Study title: van der Lee M, Verweel G, de Groot R, Burger D. Pharmacokinetics of a once-daily regimen of lopinavir/ritonavir in HIV-1-infected children. Antivir Ther. 2006;11(4):439-45 See Neth 378-00-66van der Lee M, Verweel G, de Groot R, Burger D. Pharmacokinetics of a once-daily regimen of lopinavir/ritonavir in HIV-1-infected children. Antivir Ther. 2006;11(4):439-45 See Neth 378-00-66 |
Active substance: lopinavir / ritonavir |
Study summary document link (including results): |
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Document reference: 41522 |
Study title: Comparison of fennel and mefenamic acid for the treatment of primary dysmenorrhea; Namavar Jahromi B et al. , Int J Gynaecol Obstet. 2003 Feb;80(2):153-7.Comparison of fennel and mefenamic acid for the treatment of primary dysmenorrhea; Namavar Jahromi B et al. , Int J Gynaecol Obstet. 2003 Feb;80(2):153-7. |
Active substance: MEFENAMIC ACID |
Study summary document link (including results): |
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Document reference: 41620 |
Study title: ND: 27405 AU: Van-Oudheusden-L-J, Scholte-H-R. IN: Westfries Gasthuis, Dept Pediat, POB 600, NL-1620 AR Hoorn, Netherlands. Erasmus Univ, Rotterdam, Netherlands. TI: Efficacy of carnitine in the treatment of children with attention- deficithyperactivity disorder; SO: PROSTAGLANDINS-LEUKOTRIENES-AND-ESSENTIAL-FATTY-ACIDS, 2002, V67, N1, JUL,pp 33-38 ND: 27405 AU: Van-Oudheusden-L-J, Scholte-H-R. IN: Westfries Gasthuis, Dept Pediat, POB 600, NL-1620 AR Hoorn, Netherlands. Erasmus Univ, Rotterdam, Netherlands. TI: Efficacy of carnitine in the treatment of children with attention- deficithyperactivity disorder; SO: PROSTAGLANDINS-LEUKOTRIENES-AND-ESSENTIAL-FATTY-ACIDS, 2002, V67, N1, JUL,pp 33-38 |
Active substance: LEVOCARNITINE |
Study summary document link (including results): |
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Document reference: 31144 |
Study title: Mayumi Takabatake, Department of Ophthalmology, Okayama University Medical School, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198) for external eye infections- phase III open clinical trial. No report date.Mayumi Takabatake, Department of Ophthalmology, Okayama University Medical School, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198) for external eye infections- phase III open clinical trial. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31372 |
Study title: Mayumi Takabatake, Department of Ophthalmology, Okayama University Medical School, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198) for external eye infections- phase III open clinical trial. No report date.Mayumi Takabatake, Department of Ophthalmology, Okayama University Medical School, Clinical evaluation of Lomefloxacin ophthalmic solution (NY-198) for external eye infections- phase III open clinical trial. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31387 |
Study title: Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease - Hoffman, TM et al. - 2003 (Circulation 2003; 107: 996-1002)Efficacy and safety of milrinone in preventing low cardiac output syndrome in infants and children after corrective surgery for congenital heart disease - Hoffman, TM et al. - 2003 (Circulation 2003; 107: 996-1002) |
Active substance: MILRINONE |
Study summary document link (including results): |
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Document reference: 32022 |
Study title: ASSESS THE ANALGESIC EFFICACY OF PIROXICAM IN A VARIETY OF PAINFUL CONDITIONS IN SPORTS MEDICINE, NOT SEVER ENOUGH TO REQUIRE M.S.. |
Active substance: PIROXICAM |
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Document reference: 34484 |
Study title: DRUG USE INVESTIGATIONAL OF FELDENE SUPPOSITORY IN THE TREATMENT OF VARIOUS DISEASES WITH PAIN |
Active substance: PIROXICAM |
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Document reference: 34467 |
Study title: Treatment of the West syndrome with high-dose pyridoxal phosphate - Y. Ohtsuka et al. - 1987 (Brain Dev vol 9) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of the West syndrome with high-dose pyridoxal phosphate - Y. Ohtsuka et al. - 1987 (Brain Dev vol 9) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31520 |
Study title: Vitamin B6, Magnesium and combined B6-Mg : therapeutic effects in childhood autism - J. Martineau et al. - 1985 (Biol. Psychiatry vol 20) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Vitamin B6, Magnesium and combined B6-Mg : therapeutic effects in childhood autism - J. Martineau et al. - 1985 (Biol. Psychiatry vol 20) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31521 |
Study title: Three-year experience with Novalgin inj. In the treatment of acute pain in child age: analgetic effect, safety of treatment and incidence of indesirable effects. Kralinsky K. et al.; Cs Pediat 1998; 53:689-692 - Publication in Part IC3 Clinical Documentation - HAUKE - 28/02/2000 - |
Active substance: METAMIZOLE |
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Document reference: 31707 |
Study title: Oral antipyretic therapy. Evaluation of mefenamic acid (short communication).; Similä S et al., Arzneimittelforschung. 1977;27(3):687-8Oral antipyretic therapy. Evaluation of mefenamic acid (short communication).; Similä S et al., Arzneimittelforschung. 1977;27(3):687-8 |
Active substance: MEFENAMIC ACID |
Study summary document link (including results): |
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Document reference: 31581 |
Study title: Sei-ichi Ishimoto, Department of Ophthalmology, Faculty of Medicine, Kyusyu University, Clinical evaluation of topical Lomefloxacin (NY-198) for external eye infection. No report date.Sei-ichi Ishimoto, Department of Ophthalmology, Faculty of Medicine, Kyusyu University, Clinical evaluation of topical Lomefloxacin (NY-198) for external eye infection. No report date. |
Active substance: LOMEFLOXACIN |
Study summary document link (including results): |
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Document reference: 31367 |
Study title: The safety of vitamin B6 - A.R Gaby - 1997 (J. Nutr Environ. Med vol 7) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -The safety of vitamin B6 - A.R Gaby - 1997 (J. Nutr Environ. Med vol 7) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
View full study record |
Document reference: 31498 |
Study title: Treatment of infantile spasms with high-dosage vitamin B6 - J. Pietz et al. - 1993 (Epilepsia vol 34) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of infantile spasms with high-dosage vitamin B6 - J. Pietz et al. - 1993 (Epilepsia vol 34) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
View full study record |
Document reference: 31499 |
Study title: Treatment of infantile spasms with high-dosage vitamin B6 : the Heidelberg experience 1989-1999 - J. Scholl et al. - 2000 (Neuropediatrics vol 31) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 -Treatment of infantile spasms with high-dosage vitamin B6 : the Heidelberg experience 1989-1999 - J. Scholl et al. - 2000 (Neuropediatrics vol 31) - Publication in MAGNE-B6 Magnesium - pyridoxine Tablet & Oral Solution -Response to questions raised during the renewal process in Estonia -Raphaëlle Pivaty- 04/2004 - |
Active substance: MAGNESIUM LACTATE + MAGNESIUM PIDOLATE + PYRIDOXINE (VIT B6) |
Study summary document link (including results): |
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Document reference: 31500 |
Study title: Observational use study of the tolerability of Octenisept in premature infants in the neonatal intensive care unit of Innsbruck University Hospital. University clinic for paediatric and juvenile medicine. 2000. |
Active substance: OCTENIDINE |
Study summary document link (including results): |
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Document reference: 32739 |
Study title: HAB-053 |
Active substance: inactivated hepatitis a virus and hepatitis b surface antigen (rdna) |
Study summary document link (including results): |
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Document reference: 41482 |
Study title: Immunogenicity trial of Rouvax vaccine with a new stabiliser in tunisian children |
Active substance: LIVE ATTENUATED MEASLES (SCHWARZ STRAIN) VACCINE |
Study summary document link (including results): |
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Document reference: 41239 |
Study title: Steuber CP et al Toxicity evaluation of dihydroxyanthracenedione (DHAD) in combination with cytosine arabinoside (Ara-C) Invest New Drugs. 1987 Dec;5(4):379-82 Steuber CP et al Toxicity evaluation of dihydroxyanthracenedione (DHAD) in combination with cytosine arabinoside (Ara-C) Invest New Drugs. 1987 Dec;5(4):379-82 |
Active substance: MITOXANTRONE |
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Document reference: 32088 |
Study title: Ten years experience with paravariceal injection sclerotherapy of esophageal varices in children; Paquet,K.J.;J. Pediatr. Surg.(1985) vol.20, n°2, p.109-112Ten years experience with paravariceal injection sclerotherapy of esophageal varices in children; Paquet,K.J.;J. Pediatr. Surg.(1985) vol.20, n°2, p.109-112 |
Active substance: POLIDOCANOL |
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Document reference: 46069 |
Study title: |
Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD |
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Document reference: 34566 |
Study title: A double-blind, single dose evaluation of the comparative analgesic efficacy of acetaminophen 1000 mg, ibuprofen 400 mg, ibuprofen 200 mg, and placebo in the treatment of pain following oral surgery. Stat Rpt 58. Protocol 3-278, Unpublished Report 172. |
Active substance: IBUPROFEN AND PARACETAMOL |
Study summary document link (including results): ibuprofen_paracetamol 3-278.pdf |
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Document reference: 47389 |
Study title: Open label pharmacokinetic evaluation of single oral doses of dolasetron mesilate for the prevention of acute (24-hour) nausea and vomiting in paediatric cancer patients receiving moderately to highly emetogenic chemotherapy - Lariviere - 28 April 1995 |
Active substance: DOLASETRON |
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Document reference: 26302 |
Study title: Extension of Study LUI-01-00 in Austria: LUIVAC treatment under daily life conditions in patients with recurrent respiratory tract infections including obstructive pulmonary diseases |
Active substance: Bacterial lysate |
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Document reference: 41833 |
Study title: Expertise clinique Claforan 1g I.M. préparation injectable solvant: Lidocaine - Pr J. Kermarec - 1979Expertise clinique Claforan 1g I.M. préparation injectable solvant: Lidocaine - Pr J. Kermarec - 1979 |
Active substance: CEFOTAXIME |
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Document reference: 23479 |
Study title: Short term treatment of acute urinary tract infection in girlsShort term treatment of acute urinary tract infection in girls |
Active substance: PIVAMPICILLIN |
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Document reference: 46053 |
Study title: Short term treatment with pivmecillinam in uncomplicated urinary tract infections in childrenShort term treatment with pivmecillinam in uncomplicated urinary tract infections in children |
Active substance: PIVAMPICILLIN |
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Document reference: 46059 |
Study title: Clinical evaluation of trimethoprim-containing ophthalmic solutions in humans. Lamberts DW, Buka T, Knowlton GM. Am J Ophthalmol. 1984 Jul 15;98(1):11-6.Clinical evaluation of trimethoprim-containing ophthalmic solutions in humans. Lamberts DW, Buka T, Knowlton GM. Am J Ophthalmol. 1984 Jul 15;98(1):11-6. |
Active substance: PREDNISOLONE AND SULFACETAMIDE |
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Document reference: 46113 |
Study title: |
Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD |
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Document reference: 34568 |
Study title: |
Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD |
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Document reference: 34569 |
Study title: |
Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD |
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Document reference: 34570 |
Study title: |
Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD |
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Document reference: 34571 |
Study title: Large scale multicentre safety study of inactivated hepatitis A vaccine (80 U) in children - SOUTH AMERICA |
Active substance: Hepatitis A Vaccine for Children (80 U/dose) |
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Document reference: 40915 |
Study title: A double blind, cross-over, randomized study with 2 periods of 2 weeks with 2weeks washout. To investigate the mechanisms for the clinical effects of budesonide on LAR, by measuring inflammatory cells and markers in bronchoalveolar lavage (BAL) fluid. Mean age (range): 24.5 years (17 - 30 years) |
Active substance: BUDESONIDE |
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Document reference: 48404 |
Study title: A prospective, double-blind study to evaluate whether nebulised local steroid treatment is effective in the treatment of croup in infants and young children 3 months to 4.9 years. |
Active substance: BUDESONIDE |
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Document reference: 48436 |
Study title: Pisana F.,De Pasquale C.,Foresti F. Attività psicotrofica di una associazione farmacologica nel ritardo mentale Neuropsichiatria Infantile ,n.164-165, (nuova serie), 225,1975Pisana F.,De Pasquale C.,Foresti F. Attività psicotrofica di una associazione farmacologica nel ritardo mentale Neuropsichiatria Infantile ,n.164-165, (nuova serie), 225,1975 |
Active substance: MINERALS AND VITAMINS |
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Document reference: 32047 |
Study title: Avaliacao do possivel efeito do piracetam associado aos anticonvulsivantes no tratamento das epilepsias especificas e de dificil controle. |
Active substance: PIRACETAM |
Study summary document link (including results): MRCP91B2801 - Piracetam.pdf |
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Document reference: 45904 |
Study title: An open-label study to evaluate the efficacy and tolerability of budesonide (Pulmicort®) administered by Nebuhaler® (a large volume spacer) in a Kenyan Negroid population (Men or women, 16 years or above) who had not been treated with inhaled GCS during the previous three months. |
Active substance: BUDESONIDE |
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Document reference: 48425 |
Study title: An open, prospective study to evalute the efficacy and safety of a 1-year administration of inhaled BUD via a spacer device in 16 children (3.5-7 years) with severe asthma lasting from 1 to 4 years (mean 3 years). |
Active substance: BUDESONIDE |
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Document reference: 48412 |
Study title: Tolerability of cetirizine in children. results of a prospective clinical observation study in 305 children suffering from allergic disorders of the upper respiratory tract and allergic pruritus. |
Active substance: CETIRIZINE |
Study summary document link (including results): SRCE92E2202 - Cetirizine.pdf |
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Document reference: 23783 |
Study title: Campese VM. Minoxidil: a review of its pharmacological properties and therapeutic use. Drugs 1981; 22(4):257-278Campese VM. Minoxidil: a review of its pharmacological properties and therapeutic use. Drugs 1981; 22(4):257-278 |
Active substance: MINOXIDIL |
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Document reference: 32055 |
Study title: Effect of methyldopa, propranolol, and propranolol plus minoxidil in the management of hypertension associated with renal disease in children. |
Active substance: MINOXIDIL |
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Document reference: 32063 |
Study title: Effect of minoxidil on arterial blood pressure, cardiac index, nd plasma rennin activity in 6 severely hypertensive children |
Active substance: MINOXIDIL |
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Document reference: 32062 |
Study title: Falkner B, Lurbe E and Schaefer F. High Blood Pressure in Children: Clinical and Health Policy Implications. The Journal of Clinical Hypertension. 2010; 12 (4): 261-76Falkner B, Lurbe E and Schaefer F. High Blood Pressure in Children: Clinical and Health Policy Implications. The Journal of Clinical Hypertension. 2010; 12 (4): 261-76 |
Active substance: MINOXIDIL |
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Document reference: 32053 |
Study title: Halling SE et al., Minoxidil therapy in children and young adult patients with renal disease and refractory hypertension: value when multidrug regimens have failed to achieve blood pressure control. Journal of Human Hypertension 2010;24:552-554Halling SE et al., Minoxidil therapy in children and young adult patients with renal disease and refractory hypertension: value when multidrug regimens have failed to achieve blood pressure control. Journal of Human Hypertension 2010;24:552-554 |
Active substance: MINOXIDIL |
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Document reference: 32056 |
Study title: Packer RJ et al Phase III study of craniospinal radiation therapy followed by adjuvant chemotherapy for newly diagnosed average-risk medulloblastoma. J Clin Oncol. 2006 Sep 1;24(25):4202-8Packer RJ et al Phase III study of craniospinal radiation therapy followed by adjuvant chemotherapy for newly diagnosed average-risk medulloblastoma. J Clin Oncol. 2006 Sep 1;24(25):4202-8 |
Active substance: MITOXANTRONE |
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Document reference: 32232 |
Study title: Pappo AS et al Phase II trial of neoadjuvant vincristine, ifosfamide, and doxorubicin with granulocyte colony-stimulating factor support in children and adolescents with advanced-stage nonrhabdomyosarcomatous soft tissue sarcomas: a Pediatric Oncology Group Study J Clin Oncol. 2005 Jun 20;23(18):4031-8. Epub 2005 Mar 14Pappo AS et al Phase II trial of neoadjuvant vincristine, ifosfamide, and doxorubicin with granulocyte colony-stimulating factor support in children and adolescents with advanced-stage nonrhabdomyosarcomatous soft tissue sarcomas: a Pediatric Oncology Group Study J Clin Oncol. 2005 Jun 20;23(18):4031-8. Epub 2005 Mar 14 |
Active substance: MITOXANTRONE |
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Document reference: 32168 |
Study title: Sullivan MP et al. High-dose cyclophosphamide-high-dose methotrexate with coordinated intrathecal therapy for advanced nonlymphoblastic lymphoma of childhood: results of a Pediatric Oncology Group study. Am J Pediatr Hematol Oncol. 1991 Fall;13(3):288-95. Sullivan MP et al. High-dose cyclophosphamide-high-dose methotrexate with coordinated intrathecal therapy for advanced nonlymphoblastic lymphoma of childhood: results of a Pediatric Oncology Group study. Am J Pediatr Hematol Oncol. 1991 Fall;13(3):288-95. |
Active substance: MITOXANTRONE |
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Document reference: 32251 |
Study title: Immunogenicity and safety study of two doses of Fluvirin (0.25 mL and 0.5 mL) with Vaxigrip (0.25 mL), in Healthy naive pediatric subjects aged 6 to 35 months. |
Active substance: INFLUENZA VACCINE |
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Document reference: 48403 |
Study title: An open, uncontrolled study with 3 periods, each of 3 weeks duration to assess the clinical efficacy of budesonide via nebilizer, 1000 mg bid, in chronically weezing infants, aged 2 to 12 months, and to evaluate any adrenal side-effects . |
Active substance: BUDESONIDE |
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Document reference: 48416 |
Study title: Long term, low dose treatment with pivmecillinam alone and in combination with pivampicillin in patients prone to recurrent bacteriuria; Barclay R.P.C. et al. 1982, Current medical research and opinion, 8: 82-88 Long term, low dose treatment with pivmecillinam alone and in combination with pivampicillin in patients prone to recurrent bacteriuria; Barclay R.P.C. et al. 1982, Current medical research and opinion, 8: 82-88 |
Active substance: PIVMECILLINAM |
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Document reference: 34536 |
Study title: Clinical evaluation of trimethoprim-containing ophthalmic solutions in humans. Lamberts DW, Buka T, Knowlton GM. Am J Ophthalmol. 1984 Jul 15;98(1):11-6. Clinical evaluation of trimethoprim-containing ophthalmic solutions in humans. Lamberts DW, Buka T, Knowlton GM. Am J Ophthalmol. 1984 Jul 15;98(1):11-6. |
Active substance: POLYMYXIN B AND TRIMETHOPRIM |
Study summary document link (including results): Clinical evaluation of trimethoprim-containing.pdf |
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Document reference: 25749 |
Study title: A phase II, controlled, single-center study to assess safety and immunogenicity of a primary vaccination course with one dose of Haemophilus influenzae type b (Hib) conjugate vaccine containing Aluminum Phosphate (Hib/AlPO4 vaccine), given alone or concomitantly with Measles, Mumps and Rubella Vaccine (MMR, Morupar®, licensed by Chiron, now Novartis Vaccines and Diagnostics), in healthy children 12-15 months of age. |
Active substance: Influenza Vaccine (Split Virion, Inactivated) |
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Document reference: 48391 |
Study title: A Phase II, observer-blind, randomized, multicenter, controlled study of 3 Haemophilus influenzae type b (Hib) vaccines in infants. |
Active substance: Influenza Vaccine (Split Virion, Inactivated) |
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Document reference: 48389 |
Study title: An extension, phase III, open-label, multicenter study in healthy toddlers, of two Haemophilus influenzae type b (Hib) vaccines administered as a booster dose. |
Active substance: Influenza Vaccine (Split Virion, Inactivated) |
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Document reference: 48392 |
Study title: an observer blind, randomized, parallel groups, single-center, exploratory Phase IV study to evaluate immunogenicity of two intramuscular doses of influenza vaccine in pediatric subjects. |
Active substance: Influenza Vaccine (Split Virion, Inactivated) |
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Document reference: 48387 |
Study title: An open label, single-center, pilot study to assess the safety, tolerability and immunogenicity of three injections of the HibCRM/AlPO4 vaccine, when given at 2, 3, 4 months of age to healthy infants. |
Active substance: Influenza Vaccine (Split Virion, Inactivated) |
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Document reference: 48390 |
Study title: Clinical Testing of Influsplit SSW®93 |
Active substance: Influenza Vaccine (Split Virion, Inactivated) |
Study summary document link (including results): Influsplit-1993_ synopsis.pdf |
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Document reference: 48377 |
Study title: Improved Acidosis Correction and Recovery of Mesothelial Cell Mass with Neutral-pH Bicarbonate Dialysis Solution among Children Undergoing Automated Peritoneal Dialysis, 2003 Effects of pH-neutral, bicarbonate-buffered dialysis fluid on peritoneal transport kinetics in children, 2002 Reduced Advanced Glycation Endproduct (AGE) Levels in Children on Automated Peritoneal Dialysis (PD) with PD-Fluids Containing Less Glucose Degradation Products (GDPs), 2003 |
Active substance: ISOTONIC SOLUTIONS |
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Document reference: 30757 |
Study title: Effectiveness of a Vi capsular polysaccharide vaccine |
Active substance: Inactivatd Poliomyelitis Vaccine (Vero cells) (40/8/32) |
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Document reference: 41209 |
Study title: Randomised trial of pivampicillin plus pivmecillinam vs pivampicillin in children and young adults with chronic obstructive pulmonary disease and infection with Haemophilus influenzae; Johansen HK et al 1999 Curr Med Res Opin, 15: 300-309 Randomised trial of pivampicillin plus pivmecillinam vs pivampicillin in children and young adults with chronic obstructive pulmonary disease and infection with Haemophilus influenzae; Johansen HK et al 1999 Curr Med Res Opin, 15: 300-309 |
Active substance: PIVMECILLINAM |
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Document reference: 34539 |
Study title: Slow replenishment of carnitine deficiency after cessation of longterm treatment with pivaloyl-containing antibiotics; Diep, Pharmacy World Sci Vol. 15(5), 1993. 225-229 Slow replenishment of carnitine deficiency after cessation of longterm treatment with pivaloyl-containing antibiotics; Diep, Pharmacy World Sci Vol. 15(5), 1993. 225-229 |
Active substance: PIVMECILLINAM |
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Document reference: 34529 |
Study title: Bibliography - Treatment with pristinamycin of bone and joint infections in children - P. Beauvais et al. - 1981 - Arch. Fr. Pediatr. (38:489-493)Bibliography - Treatment with pristinamycin of bone and joint infections in children - P. Beauvais et al. - 1981 - Arch. Fr. Pediatr. (38:489-493) |
Active substance: PRISTINAMYCIN |
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Document reference: 46117 |
Study title: Endovascular treatment of acute and subacute hemorrhage in the head and neck. ; Remonda-L. Archives of Otolaryngology - Head and Neck Surgery, 2000, Vol/Iss/Pg. 126/10 (1255-1262)Endovascular treatment of acute and subacute hemorrhage in the head and neck. ; Remonda-L. Archives of Otolaryngology - Head and Neck Surgery, 2000, Vol/Iss/Pg. 126/10 (1255-1262) |
Active substance: IODINE |
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Document reference: 30249 |
Study title: Miller K. Pharmacological management of hypertension in paediatric patients. A comprehensive review of the efficacy, safety and dosage guidelines of the available agents. Drugs 1994; 48: 868-87, Update on the 1987 Task Force Report on High Blood Pressure in Children and Adolescents: A Working Group Report from the National High Blood Pressure Education Program. Pediatrics 1996;98;649-658Miller K. Pharmacological management of hypertension in paediatric patients. A comprehensive review of the efficacy, safety and dosage guidelines of the available agents. Drugs 1994; 48: 868-87, Update on the 1987 Task Force Report on High Blood Pressure in Children and Adolescents: A Working Group Report from the National High Blood Pressure Education Program. Pediatrics 1996;98;649-658 |
Active substance: MINOXIDIL |
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Document reference: 32051 |
Study title: Pennisi A J et al. Minoxidil therapy in children with severe hypertension. Journal of Pediatrics.1977;90:813-9Pennisi A J et al. Minoxidil therapy in children with severe hypertension. Journal of Pediatrics.1977;90:813-9 |
Active substance: MINOXIDIL |
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Document reference: 32058 |
Study title: Puri H C et al. Severe hypertension in children with renal disease: treatment with minoxidil. American Journal of Kidney Diseases.1983;3:71-5Puri H C et al. Severe hypertension in children with renal disease: treatment with minoxidil. American Journal of Kidney Diseases.1983;3:71-5 |
Active substance: MINOXIDIL |
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Document reference: 32059 |
Study title: Sandhiya S & Dkhar SA. Potassium channels in health, disease and development of channel modulators. Indian J Med Res 2009; 129:223-232.Sandhiya S & Dkhar SA. Potassium channels in health, disease and development of channel modulators. Indian J Med Res 2009; 129:223-232. |
Active substance: MINOXIDIL |
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Document reference: 32054 |
Study title: Sinaiko and Mirkin. Management of severe childhood hypertension with minoxidil: a controlled clinical study. Journal of Pediatrics 1977;91:138-42Sinaiko and Mirkin. Management of severe childhood hypertension with minoxidil: a controlled clinical study. Journal of Pediatrics 1977;91:138-42 |
Active substance: MINOXIDIL |
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Document reference: 32052 |
Study title: Sinaiko et al. Clinical response of hypertensive children to long-term minoxidil therapy. Journal of Cardiovascular Pharmacology.1980;2 Suppl 2:S181-8Sinaiko et al. Clinical response of hypertensive children to long-term minoxidil therapy. Journal of Cardiovascular Pharmacology.1980;2 Suppl 2:S181-8 |
Active substance: MINOXIDIL |
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Document reference: 32060 |
Study title: Clinical evaluation of Nootropil (piracetam) in severe cranio-cerebral injuries. |
Active substance: PIRACETAM |
Study summary document link (including results): DE82E051P - Piracetam.pdf |
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Document reference: 46029 |
Study title: Clinical observations with regard to the effects of UCB 6215 on some brain functions in schoollchildren. |
Active substance: PIRACETAM |
Study summary document link (including results): DE73C201 - Piracetam.pdf |
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Document reference: 46017 |
Study title: Comparison effects of vascular preparates in patients with cerebrovascular pathology. |
Active substance: PIRACETAM |
Study summary document link (including results): PDEE97C1402 - Piracetam.pdf |
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Document reference: 46005 |
Study title: Strife C F et al, Pediatrics. Minoxidil for control of acute blood pressure elevation in chronically hypertensive children. 1986;78: 861-5Strife C F et al, Pediatrics. Minoxidil for control of acute blood pressure elevation in chronically hypertensive children. 1986;78: 861-5 |
Active substance: MINOXIDIL |
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Document reference: 32061 |
Study title: Suresh et al. Emergency management of pediatric hypertension. Clinical Pediatrics. 2005; 44/9:739-745Suresh et al. Emergency management of pediatric hypertension. Clinical Pediatrics. 2005; 44/9:739-745 |
Active substance: MINOXIDIL |
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Document reference: 32057 |
Study title: Pratt CB et al Novantrone for childhood malignant solid tumors. A pediatric oncology group phase II study Invest New Drugs. 1986;4(1):43-8Pratt CB et al Novantrone for childhood malignant solid tumors. A pediatric oncology group phase II study Invest New Drugs. 1986;4(1):43-8 |
Active substance: MITOXANTRONE |
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Document reference: 32078 |
Study title: Pratt CB et al Novantrone for childhood malignant solid tumors. A pediatric oncology group phase II study Invest New Drugs. 1986;4(1):43-8Pratt CB et al Novantrone for childhood malignant solid tumors. A pediatric oncology group phase II study Invest New Drugs. 1986;4(1):43-8 |
Active substance: MITOXANTRONE |
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Document reference: 32086 |
Study title: Pratt CB et al. Role of adjuvant chemotherapy in the treatment of surgically resected pediatric non-rhabdomyosarcomatous soft tissue sarcomas: A Pediatric Oncology Group Study. J Clin Oncol. 1999 Apr;17(4):1219Pratt CB et al. Role of adjuvant chemotherapy in the treatment of surgically resected pediatric non-rhabdomyosarcomatous soft tissue sarcomas: A Pediatric Oncology Group Study. J Clin Oncol. 1999 Apr;17(4):1219 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32181 |
Study title: Worden FP et al Randomized phase II evaluation of 6 g/m2 of ifosfamide plus doxorubicin and granulocyte colony-stimulating factor (G-CSF) compared with 12 g/m2 of ifosfamide plus doxorubicin and G-CSF in the treatment of poor-prognosis soft tissue sarcoma J Clin Oncol. 2005 Jan 1;23(1):105-12. Erratum in: J Clin Oncol. 2006 Sep1;24(25):4223Worden FP et al Randomized phase II evaluation of 6 g/m2 of ifosfamide plus doxorubicin and granulocyte colony-stimulating factor (G-CSF) compared with 12 g/m2 of ifosfamide plus doxorubicin and G-CSF in the treatment of poor-prognosis soft tissue sarcoma J Clin Oncol. 2005 Jan 1;23(1):105-12. Erratum in: J Clin Oncol. 2006 Sep1;24(25):4223 |
Active substance: MITOXANTRONE |
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Document reference: 32171 |
Study title: Yalcin B et al High-dose ifosfamide with hematopoietic growth factor support in advanced bone and soft tissue sarcomas Exp Oncol. 2004 Dec;26(4):320-5Yalcin B et al High-dose ifosfamide with hematopoietic growth factor support in advanced bone and soft tissue sarcomas Exp Oncol. 2004 Dec;26(4):320-5 |
Active substance: MITOXANTRONE |
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Document reference: 32170 |
Study title: Results of plasma samples analysis for mivacurium from a study of the efficacy and safety of mivacurium in paediatric patients (P45-19). TBZZ/89/0014/00 referenced in THRS/89/0031 as available on request (in D921698) . |
Active substance: MIVACURIUM |
Study summary document link (including results): Study TBZZ-89-0014-00-Mivacurium Chloride.xls |
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Document reference: 32256 |
Study title: Trimethoprim-polymyxin ophthalmic solution versus chloramphenicol ophthalmic solution in the treatment of bacterial conjunctivitis.van Rensburg SF, Gibson JR, Harvey SG, Burke CA. Pharmatherapeutica. 1982;3(4):274-7. Trimethoprim-polymyxin ophthalmic solution versus chloramphenicol ophthalmic solution in the treatment of bacterial conjunctivitis.van Rensburg SF, Gibson JR, Harvey SG, Burke CA. Pharmatherapeutica. 1982;3(4):274-7. |
Active substance: POLYMYXIN B AND TRIMETHOPRIM |
Study summary document link (including results): Trimethoprim-polymyxin B sulphate ophthalmic ointment versus chloramphenicol ophthalmic intment in the treatment of bacterial conjunctivitis.pdf |
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Document reference: 34583 |
Study title: Code 9115 2015 USA 90 - Tremblements instabilité emotionnelle. Malformation vasculaire intra-cranienne hemorragie cerebrale. Diplopie.Code 9115 2015 USA 90 - Tremblements instabilité emotionnelle. Malformation vasculaire intra-cranienne hemorragie cerebrale. Diplopie. |
Active substance: POTASSIUM CLORAZEPATE |
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Document reference: 46074 |
Study title: Clinical evaluation of perphenazine, triflupromazine, and hydroxyzine for postoperative sedation in children |
Active substance: HYDROXYZINE |
Study summary document link (including results): ADPE92B0408.pdf |
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Document reference: 29255 |
Study title: Pritchard J et al. High dose melphalan in the treatment of advanced neuroblastoma: results of arandomised trial (ENSG-1) by the European Neuroblastoma Study Group. Pediatr Blood Cancer. 2005 Apr;44(4):348-57.Pritchard J et al. High dose melphalan in the treatment of advanced neuroblastoma: results of arandomised trial (ENSG-1) by the European Neuroblastoma Study Group. Pediatr Blood Cancer. 2005 Apr;44(4):348-57. |
Active substance: MITOXANTRONE |
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Document reference: 32236 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Placenta compositum (ampoules) [AWB-AT] |
Active substance: Placenta compositum-Heel - Ampullen |
Study summary document link (including results): |
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Document reference: 40137 |
Study title: Five-year follow-up on the PAT study: specific immunotherapy and long-term prevention of asthma in children |
Active substance: Plantago Ovata Tinnevelly Senna Pods |
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Document reference: 40138 |
Study title: Nolan T et al., Randomized trial of laxatives in treatment of childhood encopresis.The Lancet 338, 1991, 8766: 523-527 |
Active substance: Plantago Ovata Tinnevelly Senna Pods/ (HERB) Ispaghula seed Ispaghula husk/ Ispaghula husk/Ispaghula seeds/Senna pods (HERB) |
Study summary document link (including results): |
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Document reference: 40036 |
Study title: Roth OA., Therapeutic observations on constipation; Med. Welt 1969;20:536-7 |
Active substance: Plantago Ovata Tinnevelly Senna Pods/ (HERB) Ispaghula seed Ispaghula husk/ Ispaghula husk/Ispaghula seeds/Senna pods (HERB) |
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Document reference: 40038 |
Study title: Sölter et al., Summary of clinical results with Prodiem Plain, a bowel-regulating agent; Today´s Therapeutic Trends (1983);1(1):45-59 |
Active substance: Plantago Ovata Tinnevelly Senna Pods/ (HERB) Ispaghula seed Ispaghula husk/ Ispaghula husk/Ispaghula seeds/Senna pods (HERB) |
Study summary document link (including results): |
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Document reference: 40039 |
Study title: Zawodsky L., Problems of a double-blind trial, as exemplified by a laxative; Der Praktische Arzt 1976;30:1182-92 |
Active substance: Plantago Ovata Tinnevelly Senna Pods/ (HERB) Ispaghula seed Ispaghula husk/ Ispaghula husk/Ispaghula seeds/Senna pods (HERB) |
Study summary document link (including results): |
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Document reference: 40037 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Plantago-Homaccord (drops) [AWB-AT] |
Active substance: Plantago-Homaccord |
Study summary document link (including results): |
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Document reference: 39767 |
Study title: Indications du Tranxene en cure ambulatoire en pédo-psychiatrie. Étude de 31 observations. - Sallou Cl. - Ver. Neuropsychiatr. Infant., 1973, 21, 701-705Indications du Tranxene en cure ambulatoire en pédo-psychiatrie. Étude de 31 observations. - Sallou Cl. - Ver. Neuropsychiatr. Infant., 1973, 21, 701-705 |
Active substance: POTASSIUM CLORAZEPATE |
Study summary document link (including results): |
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Document reference: 46080 |
Study title: Utilisation du Chlorazepate dipotassium en debut de travail - Amandruz M., Extermann Ph., Beguin F. - Med.-Hyg., 1983, 41, (1520) 2061-2065Utilisation du Chlorazepate dipotassium en debut de travail - Amandruz M., Extermann Ph., Beguin F. - Med.-Hyg., 1983, 41, (1520) 2061-2065 |
Active substance: POTASSIUM CLORAZEPATE |
Study summary document link (including results): |
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Document reference: 46082 |
Study title: Evaluation clinico-psychologique de l'effet therapeutique de deux medicaments a action neurotrope chez des sujets jeunes. |
Active substance: PIRACETAM |
Study summary document link (including results): DJ75B261 - Piracetam.pdf |
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Document reference: 45939 |
Study title: Evaluation of efficacy of piracetam in add-on treatment of partial epilepsy in children. |
Active substance: PIRACETAM |
Study summary document link (including results): ADPE98L2605 - Piracetam.pdf |
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Document reference: 46014 |
Study title: Evaluation of the effect of piracetam upon learning impairments in subjects with a border-line intellectual level. |
Active substance: PIRACETAM |
Study summary document link (including results): DE79E081 - Piracetam.pdf |
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Document reference: 45976 |
Study title: Clinical trial of the pneumococcal 23-valent vaccine in children with sickle cell disease or splenectomy (> 6 months-15 years old) |
Active substance: PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENCES) |
Study summary document link (including results): |
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Document reference: 41324 |
Study title: Safety and immunogenicity of the 23-valent pneumococcal vaccine after storage at 4°C for one year. (age 10-52 years old) |
Active substance: PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENCES) |
Study summary document link (including results): |
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Document reference: 41325 |
Study title: Safety and immunogenicity of the 23-valent vaccine in healthy children at increased risk of pneumococcal infection. (2-18 years old) |
Active substance: PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENCES) |
Study summary document link (including results): |
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Document reference: 41323 |
Study title: A Pilot Study of the Safety, Tolerability and Immunogenicity of Monovalent Pneumococcal Type 6B Conjugate Vaccine in Adults, Children and Infants |
Active substance: Pneumococcal polysaccharides (serotypes 1,2,3,4,5,6B,7F,8,9N,9V,10A,11A,12F,14,15B,17F,18C, 19F,20,22F,23F,33F) |
Study summary document link (including results): |
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Document reference: 47769 |
Study title: A Multicenter, Open-Label Study of Safety and Immunogenicity of Heptavalent Pneumococcal Conjugate Vaccine in Healthy Infants |
Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
Study summary document link (including results): |
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Document reference: 41586 |
Study title: A Phase II Randomized, Controlled Study to Determine the Safety and Immunogenicity of Two Combination Vaccines Containing Meningococcal C and Pneumococcal Capsular Polysaccharide-CRM197 Conjugates with or without PRP-CRM197 (HibTITER) in Healthy Infants |
Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
Study summary document link (including results): |
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Document reference: 41587 |
Study title: A Phase III Randomized Single-Blind Study to Evaluate the Safety of the 9-Valent Pneumococcal, Meningococcal Group C Saccharide-CRM197 Conjugate Combination Vaccine Compared to Licensed 7-Valent Pneumococcal Conjugate Vaccine (Prevnar®) Administered to Healthy Infants |
Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
Study summary document link (including results): |
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Document reference: 41588 |
Study title: A Phase III Randomized, Controlled Study to Compare the Safety and Immunogenicity of Two Different Formulations of a 9-Valent Pneumococcal, Meningococcal Group C Saccharide Conjugate Combination Vaccine Concurrently Administered at Two Different Sites With DTaP-IPV- HepB/Hib in Healthy Infants at 3, 4 and 5 Months of Age |
Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
Study summary document link (including results): |
View full study record |
Document reference: 41589 |
Study title: Bisogno G et al The IVADo regimen--a pilot study with ifosfamide, vincristine, actinomycin D, and doxorubicin in children with metastatic soft tissue sarcoma: a pilot study of behalf of the European pediatric Soft tissue sarcoma Study Group Cancer. 2005 Apr 15;103(8):1719-24Bisogno G et al The IVADo regimen--a pilot study with ifosfamide, vincristine, actinomycin D, and doxorubicin in children with metastatic soft tissue sarcoma: a pilot study of behalf of the European pediatric Soft tissue sarcoma Study Group Cancer. 2005 Apr 15;103(8):1719-24 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32169 |
Study title: DTPa-HBV-IPV-103 |
Active substance: diphtheria, tetanus, acellular pertussis, hepatitis b recombinant (adsorbed), inactivated poliovirus, adsorbed conjugated haemophilus influenzae type b vaccine |
Study summary document link (including results): |
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Document reference: 41516 |
Study title: Clinical Evaluation of 1717 L |
Active substance: PINAVERIUM |
Study summary document link (including results): pinaverium-bromide-s221.pdf |
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Document reference: 48113 |
Study title: Evaluation of the results of a study in children with unprogressive syndromes of CNS disturbances and simultaneous retarded mental development, treated with Nootropil. |
Active substance: PIRACETAM |
Study summary document link (including results): DE76C096 - Piracetam.pdf |
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Document reference: 46022 |
Study title: Rapid and safe termination of supraventricular tachycardia in children by adenosine - Clarke B., Rowland E, Barnes PJ - 1987 (Lancet, i : 299-301) Rapid and safe termination of supraventricular tachycardia in children by adenosine - Clarke B., Rowland E, Barnes PJ - 1987 (Lancet, i : 299-301) |
Active substance: ADENOSINE |
Study summary document link (including results): |
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Document reference: 46302 |
Study title: Final medical report Acceptance study with Mucosolvan 15 mg and 30 mg in children. |
Active substance: AMBROXOL |
Study summary document link (including results): Ambroxol Hydrochloride_U87-0438_Synopsis.pdf |
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Document reference: 46537 |
Study title: Guarnieri J.,Ciliberto R. Osservazioni cliniche sull’impiego di una nuova associazione antibiotica Aggior.Pediat.,23(1-2-3)1-10,1972Guarnieri J.,Ciliberto R. Osservazioni cliniche sull’impiego di una nuova associazione antibiotica Aggior.Pediat.,23(1-2-3)1-10,1972 |
Active substance: AMPICILLIN AND CLOXACILLIN |
Study summary document link (including results): |
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Document reference: 46653 |
Study title: Weston CL et al Establishing long-term survival and cure in young patients with Ewing's sarcoma Br J Cancer. 2004 Jul 19;91(2):225-32Weston CL et al Establishing long-term survival and cure in young patients with Ewing's sarcoma Br J Cancer. 2004 Jul 19;91(2):225-32 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32094 |
Study title: "Risks of intravenous amiodarone in neonates. Gandy J et al. - 1998 (Canad. J. Cardiol., 14 (6):855-858) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -" "Risks of intravenous amiodarone in neonates. Gandy J et al. - 1998 (Canad. J. Cardiol., 14 (6):855-858) ; - Publication in CES EXPCRC-CES0172-EN01, CES EXPCRC-CES0173-EN01, CES EXPCRC-CES0206-EN01 -" |
Active substance: AMIODARONE |
Study summary document link (including results): |
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Document reference: 45158 |
Study title: Betaxolol SL75.212-10 Acute oral toxicity in "young" rats - AM. Orloff, D. Branceni Betaxolol Core Dossier - April 1999 - Part III Pharmaco-toxicological documentation Volume 2 |
Active substance: BETAXOLOL |
Study summary document link (including results): |
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Document reference: 41927 |
Study title: Santini G et al. VACOP-B versus VACOP-B plus autologous bone marrow transplantation for advanced diffuse non-Hodgkin's lymphoma: results of a prospective randomized trial by the non-Hodgkin's Lymphoma Cooperative Study Group. J Clin Oncol. 1998 Aug;16(8):2796-802.Santini G et al. VACOP-B versus VACOP-B plus autologous bone marrow transplantation for advanced diffuse non-Hodgkin's lymphoma: results of a prospective randomized trial by the non-Hodgkin's Lymphoma Cooperative Study Group. J Clin Oncol. 1998 Aug;16(8):2796-802. |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32214 |
Study title: A Phase III Randomized, Double-Blind Trial to Compare the Immunogenicity of Three Unique Lots of 9-Valent Pneumococcal, Meningococcal Group C Saccharide Conjugate Combination Vaccine in Infants. Amendment to Evaluate the Responses to a Fourth Dose of DTaP Vaccine Given Concurrently with 9-Valent Pneumococcal, Meningococcal Group C Saccharide Conjugate Combination Vaccine |
Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
Study summary document link (including results): |
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Document reference: 41590 |
Study title: A Randomized, Controlled, Single-Blinded Study to Determine Equivalence of Immunogenicity Between a 7-Valent Pneumococcal Conjugate Vaccine and a 9-Valent Pneumococcal Conjugate Vaccine Administered Concurrently at Separate Sites with a DTPa/IPV+Hib Vaccine in Healthy Infants |
Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
Study summary document link (including results): |
View full study record |
Document reference: 41591 |
Study title: A Randomized, Double Blind, Study of the Safety and Immunogenicity of Nine Valent (1, 4, 5, 6B, 9V, 14, 18C, 19F, 23F) Pneumococcal Conjugate Vaccine in Healthy Infants at 2, 4, and 6 Months of Age. Amendment # 1: Safety and Immunogenicity of a Booster Dose of Nine Valent (1, 4, 5, 6B, 9V, 14, 18C, 19F, 23F) Pneumococcal Conjugate Vaccine Administered Concurrently with MMR in Toddlers 12-15 Months of Age. |
Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
Study summary document link (including results): |
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Document reference: 41592 |
Study title: An Open Label Phase I/III Study to Evaluate the Safety and Immunogenicity of Pneumococcal 7-Valent Conjugate Vaccine (DIPHTHERIA CRM197 PROTEIN) (PREVNARTM) in Healthy Infants Phase III |
Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
Study summary document link (including results): |
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Document reference: 41593 |
Study title: An Open Label Phase I/III Study to Evaluate the Safety and Immunogenicity of Pneumococcal 7-Valent Conjugate Vaccine (DIPHTHERIA CRM197 PROTEIN) (PREVNARTM) in Healthy Infants Phase III |
Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
Study summary document link (including results): |
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Document reference: 41594 |
Study title: An Open-Label Pilot Study to Evaluate the Safety Of Pneumococcal 7-Valent Conjugate Vaccine [Diphtheria Crm197 Protein] (Prevenar) in Healthy Adults and Children at 3 to 5 Years Old. |
Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
Study summary document link (including results): |
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Document reference: 41595 |
Study title: An Open-Label Trial of the Immunogenicity and Safety of Prevenar in Healthy Infants at 2, 4 and 6 months of age. |
Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
Study summary document link (including results): |
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Document reference: 41597 |
Study title: Van Winkle P et al Ifosfamide, carboplatin, and etoposide (ICE) reinduction chemotherapy in a large cohort of children and adolescents with recurrent/refractory sarcoma: the Children's Cancer Group (CCG) experience Pediatr Blood Cancer. 2005 Apr;44(4):338-47Van Winkle P et al Ifosfamide, carboplatin, and etoposide (ICE) reinduction chemotherapy in a large cohort of children and adolescents with recurrent/refractory sarcoma: the Children's Cancer Group (CCG) experience Pediatr Blood Cancer. 2005 Apr;44(4):338-47 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32159 |
Study title: Evaluation of the Safety of a Topical baby Care Product Using an Investigator-Blinded Study Design Following Four Weeks of Use in a Panel of Normal Healthy Babies and Babies with Mild Diaper Rash (2000).Evaluation of the Safety of a Topical baby Care Product Using an Investigator-Blinded Study Design Following Four Weeks of Use in a Panel of Normal Healthy Babies and Babies with Mild Diaper Rash (2000). |
Active substance: CAMPHOR AND DIPHENHYDRAMINE AND ZINC |
Study summary document link (including results): |
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Document reference: 23184 |
Study title: Cabergoline in the Treatment of Macroprolactinoma |
Active substance: CABERGOLINE |
Study summary document link (including results): 95CAPL041 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 48060 |
Study title: Randomized Controlled Comparison of PREVEsNAR booster Dose Administration at 15 or 18 Months of Age. |
Active substance: Pneumococcal saccharide conjugated vaccine, absorbed |
Study summary document link (including results): |
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Document reference: 41598 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Podophyllum compositum (drops) [AWB-AT] |
Active substance: Podophyllum compositum |
Study summary document link (including results): |
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Document reference: 39768 |
Study title: Current therapeutic strategy in bleeding esophageal varices in babies and children and long-term results of endoscopic paravariceal sclerotherapy over twenty years. Paquet,K.J.;Eur. J. Pediatr.Surg.(1994) vol.4 p.165-172 Current therapeutic strategy in bleeding esophageal varices in babies and children and long-term results of endoscopic paravariceal sclerotherapy over twenty years. Paquet,K.J.;Eur. J. Pediatr.Surg.(1994) vol.4 p.165-172 |
Active substance: POLIDOCANOL |
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Document reference: 46068 |
Study title: Gallet JP, Dicetel capsules, report of the clinical expert evaluation (in children), report no 20, May 7, 1975. |
Active substance: PINAVERIUM |
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Document reference: 34139 |
Study title: de Andrea ML et al. A new treatment protocol for childhood non-Hodgkin's lymphoma: preliminaryevaluation. J Clin Oncol. 1990 Apr;8(4):666-71de Andrea ML et al. A new treatment protocol for childhood non-Hodgkin's lymphoma: preliminaryevaluation. J Clin Oncol. 1990 Apr;8(4):666-71 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32229 |
Study title: Use of Mivacron (mivacurium chloride) in Paediatric Patients |
Active substance: MIVACURIUM |
Study summary document link (including results): |
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Document reference: 32257 |
Study title: Use of Mivacron (mivacurium chloride) in Paediatric Patients |
Active substance: MIVACURIUM |
Study summary document link (including results): |
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Document reference: 32258 |
Study title: EFFICACY, SAFETY AND PRACTICABILITY OF FLUCONAZOLE VS. LOCAL CLOTRIMAZOLE THERAPY IN PATIENTS WITH VAGINAL CANDIDIASIS. |
Active substance: FLUCONAZOLE |
Study summary document link (including results): |
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Document reference: 27788 |
Study title: A phase II, open-label, randomized, single-center, comparative study evaluating safety, tolerability and immunogenicity of three vaccinations of the DTPHib combined vaccine (Chiron Vaccines; now Novartis Vaccines) in comparison to separate vaccinations of DTP (Chiron Behring; now Novartis Vaccines) and Hib/AlPO4 (Chiron Vaccines; now Novartis Vaccines) vaccines, when administered to 2, 3, 4 months old healthy infants. |
Active substance: Adorbed, inactivated diphteria, tetanus, acellular pertussis and poliomyelitis vaccine |
Study summary document link (including results): |
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Document reference: 48393 |
Study title: A phase II, open-label, single-centre, singal-arm, extension study to evaluate the safety and immunogenicity of a booster vaccination of the DTPHib combined vaccine (Chiron Vaccines; now Novartis Vaccines) administered to 18-20 months old healthy infants who had previously received either DTPHib combined vaccine or separate administrations of DTP (Chiron Behring; now Novartis Vaccines) and Hib/AlPO4 (Chiron Vaccines; now Novartis Vaccines) vaccines at 2, 3 and 4 months of age. |
Active substance: Adorbed, inactivated diphteria, tetanus, acellular pertussis and poliomyelitis vaccine |
Study summary document link (including results): |
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Document reference: 48394 |
Study title: Neudorf S et al. Allogeneic bone marrow transplantation for children with acute myelocytic leukemia in first remission demonstrates a role for graft versus leukemia in the maintenance of disease-free survival. Blood. 2004 May 15;103(10):3655-61. Epub 2004 Jan 29Neudorf S et al. Allogeneic bone marrow transplantation for children with acute myelocytic leukemia in first remission demonstrates a role for graft versus leukemia in the maintenance of disease-free survival. Blood. 2004 May 15;103(10):3655-61. Epub 2004 Jan 29 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32193 |
Study title: A preliminary report on piracetam in sickle cell anemia: a double blind cross over clinical trial and effect on erythrocyte survival. |
Active substance: PIRACETAM |
Study summary document link (including results): DE84B023P - Piracetam.pdf |
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Document reference: 45978 |
Study title: A randomised, cross-over, double blind, placebo controlled clinical study to evaluate the effficacy of piracetam 400 mg/kg/day as add-on therpay in the treatment of cortical myoclonus of angelman syndrome. |
Active substance: PIRACETAM |
Study summary document link (including results): RRCE01G1902 -Piracetam.pdf |
View full study record |
Document reference: 45899 |
Study title: Bacci G et al Neoadjuvant chemotherapy for Ewing's sarcoma of bone: no benefit observed afteradding ifosfamide and etoposide to vincristine, actinomycin, cyclophosphamide,and doxorubicin in the maintenance phase--results of two sequential studies Cancer. 1998 Mar 15;82(6):1174-83Bacci G et al Neoadjuvant chemotherapy for Ewing's sarcoma of bone: no benefit observed afteradding ifosfamide and etoposide to vincristine, actinomycin, cyclophosphamide,and doxorubicin in the maintenance phase--results of two sequential studies Cancer. 1998 Mar 15;82(6):1174-83 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32102 |
Study title: Uchida A et al Neoadjuvant chemotherapy for pediatric osteosarcoma patients Cancer. 1997 Jan 15;79(2):411-5Uchida A et al Neoadjuvant chemotherapy for pediatric osteosarcoma patients Cancer. 1997 Jan 15;79(2):411-5 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32129 |
Study title: Multicentre study (HOE777 5D-402DT) Evaluation of efficacity and tolerance of prednicarbate 0,25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses - No author -1991 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - Multicentre study (HOE777 5D-402DT) Evaluation of efficacity and tolerance of prednicarbate 0,25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses - No author -1991 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 - |
Active substance: POLIDOCANOL AND PROTEIN-FREE DIALYSATE OF CALF BLOOD |
Study summary document link (including results): |
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Document reference: 34573 |
Study title: Eur J Nucl Med Mol Imaging. 2005 Jun;32(6):674-81. Epub 2005 Mar 4. The value of [18F]FDG-PET in the diagnosis of large-vessel vasculitis and the assessment of activity and extent of disease. Walter MA, Melzer RA, Schindler C, Müller-Brand J, Tyndall A, Nitzsche EU. |
Active substance: FLUDEOXYGLUCOSE |
Study summary document link (including results): |
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Document reference: 28108 |
Study title: Santana VM et al, MACOP-B treatment in children and adolescents with advanced diffuse large-cell non-Hodgkin's lymphoma, Leukemia. 1993 Feb;7(2):187-91Santana VM et al, MACOP-B treatment in children and adolescents with advanced diffuse large-cell non-Hodgkin's lymphoma, Leukemia. 1993 Feb;7(2):187-91 |
Active substance: BLEOMYCIN |
Study summary document link (including results): |
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Document reference: 22797 |
Study title: Olivieri A et al. Upfront high-dose sequential therapy (HDS) versus VACOP-B with or without HDS in aggressive non-Hodgkin's lymphoma: long-term results by the NHLCSG. Ann Oncol. 2005 Dec;16(12):1941-8. Epub 2005 Sep 12Olivieri A et al. Upfront high-dose sequential therapy (HDS) versus VACOP-B with or without HDS in aggressive non-Hodgkin's lymphoma: long-term results by the NHLCSG. Ann Oncol. 2005 Dec;16(12):1941-8. Epub 2005 Sep 12 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32201 |
Study title: Otten J et al Treatment of rhabdomyosarcoma and other malignant mesenchymal tumours ofchildhood with ifosfamide + vincristine + dactinomycin (IVA) as front-line therapy (a SIOP study) Cancer Chemother Pharmacol. 1989;24 Suppl 1:S30. No abstract availableOtten J et al Treatment of rhabdomyosarcoma and other malignant mesenchymal tumours ofchildhood with ifosfamide + vincristine + dactinomycin (IVA) as front-line therapy (a SIOP study) Cancer Chemother Pharmacol. 1989;24 Suppl 1:S30. No abstract available |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32152 |
Study title: Mecillinam in the treatment of neonatesMecillinam in the treatment of neonates |
Active substance: PIVAMPICILLIN |
Study summary document link (including results): |
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Document reference: 46055 |
Study title: Pivmecillinam cotrimoxazole and oral mecillinam in gastro enteritis due to vibrio sppPivmecillinam cotrimoxazole and oral mecillinam in gastro enteritis due to vibrio spp |
Active substance: PIVAMPICILLIN |
Study summary document link (including results): |
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Document reference: 46064 |
Study title: Pivmecillinam in the treatment of childhood pyelonephritisPivmecillinam in the treatment of childhood pyelonephritis |
Active substance: PIVAMPICILLIN |
Study summary document link (including results): |
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Document reference: 46058 |
Study title: Pivmecillinam in the treatment of recurrent urinary infection in girlsPivmecillinam in the treatment of recurrent urinary infection in girls |
Active substance: PIVAMPICILLIN |
Study summary document link (including results): |
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Document reference: 46060 |
Study title: Randomised trial of pivampicillin plus pivmecillinam vs pivampicillin in children and young adults with chronic obstructive pulmonary disease and infection with Haemophilus influenzaeRandomised trial of pivampicillin plus pivmecillinam vs pivampicillin in children and young adults with chronic obstructive pulmonary disease and infection with Haemophilus influenzae |
Active substance: PIVAMPICILLIN |
Study summary document link (including results): |
View full study record |
Document reference: 46067 |
Study title: Randomized trial of cefamandole plus amdinocillin versus cefamandole in serious pediatric infectionsRandomized trial of cefamandole plus amdinocillin versus cefamandole in serious pediatric infections |
Active substance: PIVAMPICILLIN |
Study summary document link (including results): |
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Document reference: 46066 |
Study title: Randomized, double blinded comparison of ciprofloxacin brasionc and pivamdinocillin tablets in the treatment of shigellosis in childrenRandomized, double blinded comparison of ciprofloxacin brasionc and pivamdinocillin tablets in the treatment of shigellosis in children |
Active substance: PIVAMPICILLIN |
Study summary document link (including results): |
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Document reference: 46065 |
Study title: Bacci G et al Neoadjuvant chemotherapy for osteosarcoma of the extremities with metastases atpresentation: recent experience at the Rizzoli Institute in 57 patients treated with cisplatin, doxorubicin, and a high dose of methotrexate and ifosfamide Ann Oncol. 2003 Jul;14(7):1126-34Bacci G et al Neoadjuvant chemotherapy for osteosarcoma of the extremities with metastases atpresentation: recent experience at the Rizzoli Institute in 57 patients treated with cisplatin, doxorubicin, and a high dose of methotrexate and ifosfamide Ann Oncol. 2003 Jul;14(7):1126-34 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32123 |
Study title: Bacci G et al Neoadjuvant chemotherapy for osteosarcoma of the extremities with synchronous lung metastases: treatment with cisplatin, adriamycin and high dose of methotrexate and ifosfamide Oncol Rep. 2000 Mar-Apr;7(2):339-46Bacci G et al Neoadjuvant chemotherapy for osteosarcoma of the extremities with synchronous lung metastases: treatment with cisplatin, adriamycin and high dose of methotrexate and ifosfamide Oncol Rep. 2000 Mar-Apr;7(2):339-46 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32127 |
Study title: Bacci G et al Neoadjuvant chemotherapy for radioinduced osteosarcoma of the extremity: The Rizzoli experience in 20 cases Int J Radiat Oncol Biol Phys. 2007 Feb 1;67(2):505-11. Epub 2006 Nov 21Bacci G et al Neoadjuvant chemotherapy for radioinduced osteosarcoma of the extremity: The Rizzoli experience in 20 cases Int J Radiat Oncol Biol Phys. 2007 Feb 1;67(2):505-11. Epub 2006 Nov 21 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32119 |
Study title: Bacci G et al Neoadjuvant treatment of Ewing's sarcoma: results obtained in 122 patientstreated with a 6-drug chemotherapeutic protocol (vincristine, adriamycin,cyclophosphamide, dactinomycin, ifosfamide and etoposide) Minerva Pediatr. 1995 Nov;47(11):457-69. ItalianBacci G et al Neoadjuvant treatment of Ewing's sarcoma: results obtained in 122 patientstreated with a 6-drug chemotherapeutic protocol (vincristine, adriamycin,cyclophosphamide, dactinomycin, ifosfamide and etoposide) Minerva Pediatr. 1995 Nov;47(11):457-69. Italian |
Active substance: MITOXANTRONE |
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Document reference: 32103 |
Study title: Shamberger RC et al. Ewing sarcoma of the rib: results of an intergroup study with analysis of outcome by timing of resection. J Thorac Cardiovasc Surg. 2000 Jun;119(6):1154-61Shamberger RC et al. Ewing sarcoma of the rib: results of an intergroup study with analysis of outcome by timing of resection. J Thorac Cardiovasc Surg. 2000 Jun;119(6):1154-61 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32180 |
Study title: Smeland S et al Scandinavian Sarcoma Group Osteosarcoma Study SSG VIII: prognostic factors foroutcome and the role of replacement salvage chemotherapy for poor histological responders Eur J Cancer. 2003 Mar;39(4):488-94Smeland S et al Scandinavian Sarcoma Group Osteosarcoma Study SSG VIII: prognostic factors foroutcome and the role of replacement salvage chemotherapy for poor histological responders Eur J Cancer. 2003 Mar;39(4):488-94 |
Active substance: MITOXANTRONE |
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Document reference: 32124 |
Study title: Wang WQ et alClinical study on mitoxantrone contained regimen for treatment of newly diagnosed childhood acute lymphoblastic leukemiaZhong Nan Da Xue Xue Bao Yi Xue Ban. 2004 Oct;29(5):602-3 Chinese (No abstract available) .Wang WQ et alClinical study on mitoxantrone contained regimen for treatment of newly diagnosed childhood acute lymphoblastic leukemiaZhong Nan Da Xue Xue Bao Yi Xue Ban. 2004 Oct;29(5):602-3 Chinese (No abstract available) . |
Active substance: MITOXANTRONE |
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Document reference: 32073 |
Study title: Guest JF, Candy D, Clegg JP et al – Clinical and economic impact of using macrogol 3350 plus electrolytes in an outpatient setting compared to enemas and suppositories and manual evacuation to treat paediatric faecal impaction based on actual clinical proactive in England and Wales. Curr Med Res Opin. 2007 Sep;23(9):2213-25 |
Active substance: POLIDOCANOL COMBINATIONS |
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Document reference: 34580 |
Study title: CROSSOVER COMPARATIVE PHARMACOKINETIC STUDY OF TWO 3MG PRAZOSIN SUSTAINED RELEASE DELIVERY SYSTEMS: SIXTEEN HOUR VS TWENTY HOUR 85% RELEASE TIMES |
Active substance: PRAZOCIN |
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Document reference: 46105 |
Study title: TO CONFIRM THE EFFICACY AND TOLERANCE OF TREATMENT WITH PRAZOSIN ASSOCIATED WITH CHLORTHALIDONE AND WITH FUROSEMIDE IN PATIENTS WITH ESSENTIAL HYPERTENSION. |
Active substance: PRAZOCIN |
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Document reference: 46110 |
Study title: TO DETERMINE WHETHER THE ADDITION OF ORALLY ADMINISTERED PRAZOSIN IMPROVES PULMONARY FUNCTION IN PATIENTS WITH CHRONIC ASTHMA. |
Active substance: PRAZOCIN |
Study summary document link (including results): |
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Document reference: 46111 |
Study title: TOLERATION OF PIROXICAM IN PATIENTS WITH PRIMARY DYSMENORRHOEA. |
Active substance: PRAZOCIN |
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Document reference: 46106 |
Study title: LONG TERM FOLLOW-UP EXPERIENCE IN A MINIZIDE TABLET (0.5MG PRAZOSIN/0.25MG POLYTHIAZIDE) MULTICENTER TRIAL |
Active substance: PRAZOCIN /POLYTHIAZIDE |
Study summary document link (including results): MZ-76-03 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 46107 |
Study title: Minizide (Brand of Prazosin/Polythiazide) Tablets (0.5 mg/0.25 mg) Clinical Experience in a Non-Comparative, Multicenter Trial |
Active substance: PRAZOCIN /POLYTHIAZIDE |
Study summary document link (including results): MZ-76-01 and MZ-76-02 EMA Pediatric Web Synopsis.pdf |
View full study record |
Document reference: 46108 |
Study title: Shewring DJ, Savage R, Thomas G. Experience of the early use of technetium 99 bone scintigraphy in wrist injury. J Hand Surg [Br]. 1994 Feb;19(1):114-7. Shewring DJ, Savage R, Thomas G. Experience of the early use of technetium 99 bone scintigraphy in wrist injury. J Hand Surg [Br]. 1994 Feb;19(1):114-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43634 |
Study title: Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44206 |
Study title: Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44253 |
Study title: Transient synovitis of the hip in the child. Wingstrand H. Acta Orthop Scand Suppl. 1986;219:1-61. No abstract available. PMID: 3518331 [PubMed - indexed for MEDLINE] |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43923 |
Study title: Wolff MH, Sty JR. Painful ankle. Os trigonum vs fracture. Clin Nucl Med. 1985 Mar;10(3):197. No abstract available. Wolff MH, Sty JR. Painful ankle. Os trigonum vs fracture. Clin Nucl Med. 1985 Mar;10(3):197. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43954 |
Study title: Use of Stereotactic PET Images in Dosimetry Planning of Radiosurgery for Brain Tumors: Clinical Experience and Proposed ClassificationTHE JOURNAL OF NUCLEAR MEDICINE, Vol. 45, No. 7, July 2004. Marc Levivier, MD, PhD1; Nicolas Massager, MD1; David Wikler, MS2; Jose´ Lorenzoni, MD1; Salvador Ruiz, MD1; Daniel Devriendt, MD3; Philippe David, MD4; Franc¸oise Desmedt, MS3; Ste´phane Simon, MS3; Paul Van Houtte, MD3; Jacques Brotchi, MD1; and Serge Goldman, MD2 |
Active substance: Steripet |
Study summary document link (including results): levivier-2004.pdf |
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Document reference: 48737 |
Study title: Vrasse, R., Schuhmann, C., and Regenstreif, P. [Action of the anthraquinone derivatives of the rhubarb in 47 cases of gingivostomatitis] Action des derives anthraquinoniques de la rhubarbe dans 47 cas de gingivostomatites. Rev.Fr.Odontostomatol. 1967. 14: (7) 1215-1220 47 subjects, 11f, 36 m, 16-84 yVrasse, R., Schuhmann, C., and Regenstreif, P. [Action of the anthraquinone derivatives of the rhubarb in 47 cases of gingivostomatitis] Action des derives anthraquinoniques de la rhubarbe dans 47 cas de gingivostomatites. Rev.Fr.Odontostomatol. 1967. 14: (7) 1215-1220 47 subjects, 11f, 36 m, 16-84 y |
Active substance: RHUBARB AND SALICYLIC ACID |
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Document reference: 35295 |
Study title: TO EVALUATE THE EFFICACY AND SAFETY OF PIROXICAM SUPPOSITORY IN PATIENTS WITH OSTEOARTHRITIS OF HIP/KNEE LUMBAGO OR TRAUMA. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34405 |
Study title: A comparison of Pondocillin® and Calcipen® in children with acute otitis media |
Active substance: PIVAMPICILLIN |
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Document reference: 46046 |
Study title: Pineoblastoma imaged during bone scintigraphy. McCormack S, Raftery R, Palmgren D, Leonard JC. Clin Nucl Med. 1995 Nov;20(11):1023-4. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43580 |
Study title: Sandler MS, Heyman S, Watts H. Localization of 99mTc methylene diphosphonate within synovial fluid in osteosarcoma. AJR Am J Roentgenol. 1984 Aug;143(2):349-50. No abstract available. Sandler MS, Heyman S, Watts H. Localization of 99mTc methylene diphosphonate within synovial fluid in osteosarcoma. AJR Am J Roentgenol. 1984 Aug;143(2):349-50. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43990 |
Study title: Sartoris DJ, Resnick DL. Tarsal coalition. Arthritis Rheum. 1985 Mar;28(3):331-8. No abstract available. Sartoris DJ, Resnick DL. Tarsal coalition. Arthritis Rheum. 1985 Mar;28(3):331-8. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43955 |
Study title: Secondary ossification center of transverse process: a bone-scan normal variant. Shore RM, Cain GP, Lloyd TV. Eur J Nucl Med. 1985;10(1-2):88-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43971 |
Study title: Shore RM, Frye TR, Weis LD, Mulne AF. Pleural metastasis with osteosarcoma. Dramatic presentation on skeletal scintigraphy. Clin Nucl Med. 1984 Nov;9(11):622-4. No abstract available. Shore RM, Frye TR, Weis LD, Mulne AF. Pleural metastasis with osteosarcoma. Dramatic presentation on skeletal scintigraphy. Clin Nucl Med. 1984 Nov;9(11):622-4. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43976 |
Study title: Clival osteoblastoma in a child. Case illustration. McDonald PJ, Matouk CC, Papsin B, Rutka JT. J Neurosurg. 2003 May;98(5):1133. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43422 |
Study title: McKendry RJ, Hamdy H. Acne, arthritis and sacroiliitis. Can Med Assoc J. 1983 Jan 15;128(2):156-8. No abstract available. McKendry RJ, Hamdy H. Acne, arthritis and sacroiliitis. Can Med Assoc J. 1983 Jan 15;128(2):156-8. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44053 |
Study title: Nuclear medicine studies in evaluation of skeletal lesions in children with histiocytosis X. Siddiqui AR, Tashjian JH, Lazarus K, Wellman HN, Baehner RL. Radiology. 1981 Sep;140(3):787-9. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44111 |
Study title: Siddiqui AR. Increased uptake of technetium-99m-labeled bone imaging agents in the kidneys. Semin Nucl Med. 1982 Jan;12(1):101-2. No abstract available. Siddiqui AR. Increased uptake of technetium-99m-labeled bone imaging agents in the kidneys. Semin Nucl Med. 1982 Jan;12(1):101-2. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44105 |
Study title: [Clinical evaluation of multiple exostoses (17 cases) on bone scintigraphy] Japanese. Yamada T, Nakamura M, Sugita R, Satou A, Sakamoto K. Nippon Igaku Hoshasen Gakkai Zasshi. 1991 Mar 25;51(3):282-8. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43744 |
Study title: Tc-99m MDP uptake by an advanced colon cancer lesion in a juvenile patient. Yamada T, Shuke N, Takahashi K, Katada R, Mineta M, Nagasawa K, Hanaoka H, Aburano T, Miyamoto K, Suzuki Y. Clin Nucl Med. 2000 Apr;25(4):295-6. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43487 |
Study title: Yamagishi Y, Komata K, Yamamoto H, Takahashi M, Hikita F, Sato M, Watanabe H. [Usefulness of 99mTc-MDP scintigraphy for normal roentgen variants of bone] Kaku Igaku. 1993 May;30(5):549-56. Japanese. Yamagishi Y, Komata K, Yamamoto H, Takahashi M, Hikita F, Sato M, Watanabe H. [Usefulness of 99mTc-MDP scintigraphy for normal roentgen variants of bone] Kaku Igaku. 1993 May;30(5):549-56. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43667 |
Study title: Yamagishi Y. [Bone scintigraphy] Nippon Ika Daigaku Zasshi. 1992 Feb;59(1):70-4. Japanese. No abstract available. Yamagishi Y. [Bone scintigraphy] Nippon Ika Daigaku Zasshi. 1992 Feb;59(1):70-4. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43709 |
Study title: Yamagishi Y. [Role of the scintigram in the diagnosis of bones and calcifications] Rinsho Hoshasen. 1986 Apr;31(4):499-504. Japanese. No abstract available. Yamagishi Y. [Role of the scintigram in the diagnosis of bones and calcifications] Rinsho Hoshasen. 1986 Apr;31(4):499-504. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43913 |
Study title: Yang CC, Wu CC, Chen MF. [Bone metastases of malignancies. A radionuclide study] Gaoxiong Yi Xue Ke Xue Za Zhi. 1986 Jul;2(7):435-45. Chinese. No abstract available. Yang CC, Wu CC, Chen MF. [Bone metastases of malignancies. A radionuclide study] Gaoxiong Yi Xue Ke Xue Za Zhi. 1986 Jul;2(7):435-45. Chinese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43903 |
Study title: Van Den Bossche B, Lambert B, De Winter F, Kolindou A, Dierckx RA, Noens L, et al.. 18FDG PET versus high-dose 67Ga scintigraphy for restaging and treatment follow-up of lymphoma patients. [vanden-bossche-2002]Nucl Med Commun. 2002 Nov;23(11):1079-83. Van Den Bossche B 2002 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48707 |
Study title: Vander Borght T, Laloux P, Maes A, Salmon E, Goethals I, Goldman S; Belgian Society for Nuclear Medicine.. Guidelines for brain radionuclide imaging. Perfusion single photon computed tomography (SPECT) using Tc-99m radiopharmaceuticals and brain metabolism positron emission tomography (PET) using F-18 fluorodeoxyglucose. The Belgian Society for Nuclear Medicine. [vander-borght-2001]Acta Neurol Belg. 2001 Dec;101(4):196-209. Vander Borght T 2001 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48708 |
Study title: Utilisation du Tranxene 5 mg gélules en pédo-psychiatrie - Sauvage D., Psychol. Méd., 1975, 7, 1637-1643Utilisation du Tranxene 5 mg gélules en pédo-psychiatrie - Sauvage D., Psychol. Méd., 1975, 7, 1637-1643 |
Active substance: POTASSIUM CLORAZEPATE |
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Document reference: 46083 |
Study title: Yang JS. [Evaluation of 113mIn-DTPMP and 99mTc-MDP for bone scanning] Zhonghua Fang She Xue Za Zhi. 1984 Feb;18(1):58-62. Chinese. No abstract available. Yang JS. [Evaluation of 113mIn-DTPMP and 99mTc-MDP for bone scanning] Zhonghua Fang She Xue Za Zhi. 1984 Feb;18(1):58-62. Chinese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44006 |
Study title: Evaluation of activity of epiphyseal plates in growing males and females. Yang KT, Yang AD. Calcif Tissue Int. 2006 Jun;78(6):348-56. Epub 2006 Jun 21. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43374 |
Study title: Nonfunctioning adrenocortical tumor showing concentration of Tc-99m MDP in a child. Yen TC, Yeh SH. Clin Nucl Med. 1996 Jul;21(7):579-80. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43564 |
Study title: McLean RG, Murray IP. Case report 292. Diagnosis: alveolar rhabdomyosarcoma, metastatic to the right femur, primary site undetermined. Skeletal Radiol. 1984;12(4):288-93. No abstract available. McLean RG, Murray IP. Case report 292. Diagnosis: alveolar rhabdomyosarcoma, metastatic to the right femur, primary site undetermined. Skeletal Radiol. 1984;12(4):288-93. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44011 |
Study title: Meire E, Hoogmartens M, De Roo M, Mortelmans L, Nicolai D. The peroperative use of the mobile gamma camera for the localization of spinal osteoid osteoma. Acta Orthop Belg. 1983 May-Jun;49(3):384-90. No abstract available. Meire E, Hoogmartens M, De Roo M, Mortelmans L, Nicolai D. The peroperative use of the mobile gamma camera for the localization of spinal osteoid osteoma. Acta Orthop Belg. 1983 May-Jun;49(3):384-90. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44037 |
Study title: "Long-term observation of treatment with topical corticosteroid prednicarbate - E.W. Schmitt et al. - 1989 (Z. Hautkr vol 64) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" "Long-term observation of treatment with topical corticosteroid prednicarbate - E.W. Schmitt et al. - 1989 (Z. Hautkr vol 64) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" |
Active substance: PREDNICARBATE |
Study summary document link (including results): |
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Document reference: 34673 |
Study title: A randomized crossover trial of combination pharmacologic therapy in children with familial hypercholesterolemia |
Active substance: PRAVASTATIN |
Study summary document link (including results): |
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Document reference: 46091 |
Study title: Dyslipidemia in pediatric renal disease: epidemiology, pathophysiology and management |
Active substance: PRAVASTATIN |
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Document reference: 46093 |
Study title: Effects of combination therapy consisting of moderate-dose intravenous immunoglobulin G, pulses methylprednisolone and pravastatin in children with steroid resistant nephrosis |
Active substance: PRAVASTATIN |
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Document reference: 46094 |
Study title: Effects of pravastatin therapy on steroid hormone levels and pubertal development in children and adolescents with hypercholesterolemia |
Active substance: PRAVASTATIN |
Study summary document link (including results): |
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Document reference: 46095 |
Study title: Long-term safety of Pravastatin in children with familial hyper-cholesterolaemia |
Active substance: PRAVASTATIN |
Study summary document link (including results): |
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Document reference: 46096 |
Study title: Pharmacokinetics of Pravastatin in a paediatric population |
Active substance: PRAVASTATIN |
Study summary document link (including results): |
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Document reference: 46097 |
Study title: Pravastatin ameliorates hypercholesterolemia in pediatric renal transplant recipients |
Active substance: PRAVASTATIN |
Study summary document link (including results): |
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Document reference: 46098 |
Study title: Minizide (Brand of Prazosin/Polythiazide) Tablets (0.5 mg/0.25 mg) Clinical Experience in a Non-Comparative, Multicenter Trial |
Active substance: PRAZOCIN /POLYTHIAZIDE |
Study summary document link (including results): MZ-76-01 and MZ-76-02 EMA Pediatric Web Synopsis.pdf |
View full study record |
Document reference: 46109 |
Study title: A double-blind multicentre parallel group study comparing HOE777 fatty ointment with betamethasone valerate 0,1% fatty ointment in patients with mild to severe atopic or eczematous contact dermatitis - M. Dietz et al. - 1982 (unpublished report) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991 |
Active substance: PREDNICARBATE |
Study summary document link (including results): Prednicarbate STUDY Dietz.xls |
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Document reference: 34665 |
Study title: "Management of scalp psoriasis. Guidelines for corticosteroid use in combination treatment - CJM. Van der Vleuten et al. - 2001 (Drugs vol 61) - Publication in Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005 -" "Management of scalp psoriasis. Guidelines for corticosteroid use in combination treatment - CJM. Van der Vleuten et al. - 2001 (Drugs vol 61) - Publication in Clinical Expert Statement- Renewal application for : Prednicarbate (INN) all forms - T. Darragon - 03/06/2005 -" |
Active substance: PREDNICARBATE |
Study summary document link (including results): |
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Document reference: 34674 |
Study title: "Multicentre study (HOE777 5D-402DT) Evaluation of efficacity and tolerance of prednicarbate 0,25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses - No author -1991 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" "Multicentre study (HOE777 5D-402DT) Evaluation of efficacity and tolerance of prednicarbate 0,25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses - No author -1991 (unpublished report) - Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 -" |
Active substance: PREDNICARBATE |
Study summary document link (including results): |
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Document reference: 34675 |
Study title: "Patch testing with HOE777 ointment, 0,1% and 0,25% and non-medicated ointment, with and without preservatives -H. Tronnier - 1984 (unpublished report) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-" "Patch testing with HOE777 ointment, 0,1% and 0,25% and non-medicated ointment, with and without preservatives -H. Tronnier - 1984 (unpublished report) - Publication in Clinical Expert report : The topical Corticosteroid Prednicarbate - W. Schulz et al. - 10/ 1991-" |
Active substance: PREDNICARBATE |
Study summary document link (including results): |
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Document reference: 34677 |
Study title: Memory effects of a group of newly-synthesized pyrolidine derivatives with putative nootropic effect. |
Active substance: PIRACETAM |
Study summary document link (including results): PDEE92G0605 - Piracetam.pdf |
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Document reference: 46039 |
Study title: Issels RD et al Ifosfamide plus etoposide combined with regional hyperthermia in patients with locally advanced sarcomas: a phase II study J Clin Oncol. 1990 Nov;8(11):1818-29Issels RD et al Ifosfamide plus etoposide combined with regional hyperthermia in patients with locally advanced sarcomas: a phase II study J Clin Oncol. 1990 Nov;8(11):1818-29 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32162 |
Study title: Entz-Werle N et al Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogenic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group reportLeukemia. 2005 Dec;19(12):2072-81.Entz-Werle N et al Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogenic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group reportLeukemia. 2005 Dec;19(12):2072-81. |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32074 |
Study title: Entz-Werle N et al Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogenic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group reportLeukemia. 2005 Dec;19(12):2072-81.Entz-Werle N et al Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogenic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group reportLeukemia. 2005 Dec;19(12):2072-81. |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32084 |
Study title: Ferrari S et al Neoadjuvant chemotherapy with high-dose Ifosfamide, high-dose methotrexate,cisplatin, and doxorubicin for patients with localized osteosarcoma of theextremity: a joint study by the Italian and Scandinavian Sarcoma Groups J Clin Oncol. 2005 Dec 1;23(34):8845-52. Epub 2005 Oct 24Ferrari S et al Neoadjuvant chemotherapy with high-dose Ifosfamide, high-dose methotrexate,cisplatin, and doxorubicin for patients with localized osteosarcoma of theextremity: a joint study by the Italian and Scandinavian Sarcoma Groups J Clin Oncol. 2005 Dec 1;23(34):8845-52. Epub 2005 Oct 24 |
Active substance: MITOXANTRONE |
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Document reference: 32120 |
Study title: Kolb EA et al Long-term event-free survival after intensive chemotherapy for Ewing's family of tumors in children and young adults J Clin Oncol. 2003 Sep 15;21(18):3423-30Kolb EA et al Long-term event-free survival after intensive chemotherapy for Ewing's family of tumors in children and young adults J Clin Oncol. 2003 Sep 15;21(18):3423-30 |
Active substance: MITOXANTRONE |
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Document reference: 32109 |
Study title: Kushner BH et al Desmoplastic small round-cell tumor: prolonged progression-free survival with aggressive multimodality therapy J Clin Oncol. 1996 May;14(5):1526-31Kushner BH et al Desmoplastic small round-cell tumor: prolonged progression-free survival with aggressive multimodality therapy J Clin Oncol. 1996 May;14(5):1526-31 |
Active substance: MITOXANTRONE |
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Document reference: 32089 |
Study title: Radiographic and scintigraphic features of modeling and remodeling in the heterotopic skeleton of patients who have fibrodysplasia ossificans progressiva. Kaplan FS, Strear CM, Zasloff MA. Clin Orthop Relat Res. 1994 Jul;(304):238-47. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43621 |
Study title: Karanauskas S, Wells RG, Sty JR. Abnormal Tc-99m MDP accumulation in a pyelocaliceal diverticulum. Clin Nucl Med. 1991 Sep;16(9):690-1. No abstract available. Karanauskas S, Wells RG, Sty JR. Abnormal Tc-99m MDP accumulation in a pyelocaliceal diverticulum. Clin Nucl Med. 1991 Sep;16(9):690-1. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43729 |
Study title: Karimeddini MK, Spencer RP. Bone agent and radiogallium deposition around infiltrated calcium gluconate. Clin Nucl Med. 1993 Sep;18(9):797-8. No abstract available. Karimeddini MK, Spencer RP. Bone agent and radiogallium deposition around infiltrated calcium gluconate. Clin Nucl Med. 1993 Sep;18(9):797-8. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43651 |
Study title: Simons KS, Pickkers P, Bleeker-Rovers CP, Oyen WJ, van der Hoeven JG.. Epub 2009 Oct 22. F-18-fluorodeoxyglucose positron emission tomography combined with CT in critically ill patients with suspected infection. [simons-2010]Intensive Care Med. 2010 Mar;36(3):504-11. Simons KS 2010 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48699 |
Study title: Sood S, Chugani HT.. Epub 2006 Jun 24. Functional neuroimaging in the preoperative evaluation of children with drugresistant epilepsy. [sood-2006]Childs Nerv Syst. 2006 Aug;22(8):810-20. Sood S 2006 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48700 |
Study title: Observational study of patients suffering from seasonal allergic rhinoconjunctivitis treated with mizolastine 10 mg during 14-28 days. |
Active substance: MIZOLASTINE |
Study summary document link (including results): Mizolastine-Study 2.pdf |
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Document reference: 32267 |
Study title: Observational study of patients suffering from seasonal allergic rhinoconjunctivitis treated with Misolastine 10mg (OD) during 14-28 days (PANEOS study). Murrietta M. 04/10/1999. |
Active substance: MIZOLASTINE |
Study summary document link (including results): |
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Document reference: 32269 |
Study title: A 6-Week, Double-Blind, Placebo-Controlled, Parallel-Group Randomized-Withdrawel Study to Evaluate the Continued Efficacy of Modafinil at Dosages Up to 425 mg/day in Patients with Attention-Defizit/Hyperactivity Disorder who are Resonders to Modafinil Treatment, Followed by a 12-month Open-Label Extension Period. |
Active substance: MODAFINIL |
Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls |
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Document reference: 45280 |
Study title: Pravastatin in the treatment of secondary hypercholesterolemia in Alagille's syndrome |
Active substance: PRAVASTATIN |
Study summary document link (including results): |
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Document reference: 46099 |
Study title: Safety and efficacy of pravastatin in pediatric heart transplant patients |
Active substance: PRAVASTATIN |
Study summary document link (including results): |
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Document reference: 46101 |
Study title: A double-blind two centre parallel group study comparing HOE777 0.25% aqueous cream, with betamethasone valerate 0.1% aqueous cream in patients with slight to very severe atopic or excematous contact dermatitis |
Active substance: PREDNICARBATE |
Study summary document link (including results): Prednicarbate STUDY Pestzoldt.xls |
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Document reference: 48014 |
Study title: [Diagnostic evaluation of skeletal scintigraphy in comparison to roentgen studies in histiocytosis X in childhood. Case report] German. Wagenknecht C, Lips H, Nitz I, Hilgenfeld E. Kinderarztl Prax. 1990 Jul;58(7):355-62. German. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43760 |
Study title: Positive bone scan in cat-scratch disease. Walterspiel JN, Nimityongskul P. Pediatr Infect Dis J. 1987 Oct;6(10):944-5. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43843 |
Study title: Walz D, Craig BM, McGinnis KD. Bone imaging showing shin splints and stress fractures. Clin Nucl Med. 1987 Oct;12(10):822. No abstract available. Walz D, Craig BM, McGinnis KD. Bone imaging showing shin splints and stress fractures. Clin Nucl Med. 1987 Oct;12(10):822. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43844 |
Study title: Watanabe O, Hashimoto M, Tomura N, Watarai J. [Evaluation of usefulness of bone SPECT for lumbar spondylolysis] Nippon Igaku Hoshasen Gakkai Zasshi. 2002 Jul;62(8):423-9. Japanese. Watanabe O, Hashimoto M, Tomura N, Watarai J. [Evaluation of usefulness of bone SPECT for lumbar spondylolysis] Nippon Igaku Hoshasen Gakkai Zasshi. 2002 Jul;62(8):423-9. Japanese. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43443 |
Study title: Tan LT, Ong KL.. Semiquantitative measurements of normal organs with variable metabolic activity on FDG PET imaging. [tan-2004]Ann Acad Med Singapore. 2004 Mar;33(2):183-5. Tan LT 2004 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48703 |
Study title: Safety and efficacy of pravastatin therapy for the prevention of hyperlipidemia in pediatric and adolescent cardiac transplant patients |
Active substance: PRAVASTATIN |
Study summary document link (including results): |
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Document reference: 46102 |
Study title: Short-term efficacy and safety of pravastatin in 72 children with familial hypercholesterolemia |
Active substance: PRAVASTATIN |
Study summary document link (including results): |
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Document reference: 46103 |
Study title: Should pediatric patients with hyperlipidemia receive drug therapy? |
Active substance: PRAVASTATIN |
Study summary document link (including results): |
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Document reference: 46104 |
Study title: " Kurian-B-T, Ray-W-A, Arbogast-P-G, Fuchs-D-C, Dudley-J-A, Cooper-W-O. Dr. W.O. Cooper, Department of Pediatrics, Vanderbilt University Medical Center, AA-0216 MCN, Nashville, TN 37232, United States e-mail: william.cooper@vanderbilt.edu. Effect of regulatory warnings on antidepressant prescribing for children and adolescents. Archives of Pediatrics and Adolescent Medicine {ARCH-PEDIATR-ADOLESC- MED}, 2007, Vol/Iss/Pg. 161/7 (690-696), eISSN: 1538-3628, ISSN: 1072-4710. " " Kurian-B-T, Ray-W-A, Arbogast-P-G, Fuchs-D-C, Dudley-J-A, Cooper-W-O. Dr. W.O. Cooper, Department of Pediatrics, Vanderbilt University Medical Center, AA-0216 MCN, Nashville, TN 37232, United States e-mail: william.cooper@vanderbilt.edu. Effect of regulatory warnings on antidepr... |
Active substance: PRAZEPAM |
Study summary document link (including results): |
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Document reference: 34641 |
Study title: "Le-Heuzey-M-F, Jacqz-Aigrain-E. M.F. Le Heuzey, Serv. Psychopathol. l'Enfant/l'Adol., Hopital Robert Debre, 48, boulevard Serurier, 75019 Paris, France e-mail: marie-france.leheuzey@rdb.ap-hop-paris.fr. Drugs and sleep disorders in children. Archives de Pediatrie {ARCH-PEDIATR}, 2002, Vol/Iss/Pg. 9/SUPPL. 2 (187s-189s), ISSN: 0929-693X." " "Le-Heuzey-M-F, Jacqz-Aigrain-E. M.F. Le Heuzey, Serv. Psychopathol. l'Enfant/l'Adol., Hopital Robert Debre, 48, boulevard Serurier, 75019 Paris, France e-mail: marie-france.leheuzey@rdb.ap-hop-paris.fr. Drugs and sleep disorders in children. Archives de Pediatrie {ARCH-PEDIATR}, 2002, Vol/Iss/Pg. 9/SUPPL. 2 (187s-189s), ISSN: 0929-693X." " |
Active substance: PRAZEPAM |
Study summary document link (including results): |
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Document reference: 34643 |
Study title: A four-weeks evaluation of HOE777 fatty ointment 0,25%in young patients with severe atopic dermatitis of long duration - G. Rajka - 1987 (unpublished report) Publication in Clinical Expert report INN : prednicarbate (HOE 777) - W. Schalla -12/1999 |
Active substance: PREDNICARBATE |
Study summary document link (including results): Prednicarbate STUDY Rajka.xls |
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Document reference: 34657 |
Study title: The therapeutic value of Nootropil (piracetam-UCB) in pediatric neurosurgery. Preliminary report. |
Active substance: PIRACETAM |
Study summary document link (including results): DE75L071P - Piracetam.pdf |
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Document reference: 46027 |
Study title: The value of the use of piracetam (UCB 6215) in adjustment disturbances of children |
Active substance: PIRACETAM |
Study summary document link (including results): CE72B281 - Piracetam.pdf |
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Document reference: 45937 |
Study title: Therapeutic evaluation of Nootropil (piracetam) in pediatric neurosurgery. |
Active substance: PIRACETAM |
Study summary document link (including results): PDEE92K2608 - Piracetam.pdf |
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Document reference: 46028 |
Study title: Evaluation of temporal and facial osteomyelitis by simultaneous In-WBC/Tc-99m-MDP bone SPECT scintigraphy and computed tomography scan. Weber PC, Seabold JE, Graham SM, Hoffmann HH, Simonson TM, Thompson BH. Otolaryngol Head Neck Surg. 1995 Jul;113(1):36-41. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43594 |
Study title: [Extraosseous tumor uptake of 99m technetium methylendiphosphonate in children with neuroblastoma (author's transl)] Italian Mancini AF, Turba E, Vallicelli R, Vitelli A, Fini A, Rosito P. Pediatr Med Chir. 1981 Nov-Dec;3(6):535-9. Italian. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44189 |
Study title: The Utility of a 3-Dimensional, Large-Field-Of-View, Sodium Iodide Crystal–Based PET Scanner in the Presurgical Evaluation of Partial EpilepsyTHE JOURNAL OF NUCLEAR MEDICINE ,Vol. 42, No. 8, August 2001. Terence J. O’Brien, Rodney J. Hicks, Robert Ware, David S. Binns, Michael Murphy, and Mark J. Cook |
Active substance: Steripet |
Study summary document link (including results): obrien-2001.pdf |
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Document reference: 48740 |
Study title: The Value of 18F-FDG PET in the Detection of Stage M0 Carcinoma of the NasopharynxJ Nucl Med 2005; 46:405–410 .Tzu-Chen Yen, MD, PhD1; Joseph Tung-Chieh Chang, MD, MHA2; Shu-Hang Ng, MD3; Yu-Chen Chang, MD1; Sheng-Chieh Chan, MD1; Kun-Ju Lin, MD1; Wuu-Jyh Lin, PhD4; Ying-Kai Fu, PhD4; and Chen-Yu Lin2 |
Active substance: Steripet |
Study summary document link (including results): yen-2005-b.pdf |
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Document reference: 48748 |
Study title: Laver JH et al. Results of a randomized phase III trial in children and adolescents with advanced stage diffuse large cell non-Hodgkin's lymphoma: a Pediatric Oncology Group study. Leuk Lymphoma. 2002 Jan;43(1):105-9Laver JH et al. Results of a randomized phase III trial in children and adolescents with advanced stage diffuse large cell non-Hodgkin's lymphoma: a Pediatric Oncology Group study. Leuk Lymphoma. 2002 Jan;43(1):105-9 |
Active substance: MITOXANTRONE |
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Document reference: 32205 |
Study title: Mandell GA, Heyman S. Mid-line circular photopenic defects of the sternum. Br J Radiol. 1983 Oct;56(670):761-3. No abstract available. Mandell GA, Heyman S. Mid-line circular photopenic defects of the sternum. Br J Radiol. 1983 Oct;56(670):761-3. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44026 |
Study title: Rivera-Rodriguez JE, Rodriguez AA, Turnbull GL, Moreno AJ. Scintigraphic evaluation with Tc-99m MDP and Ga-67 citrate in a case of pediatric T-cell lymphoma. Clin Nucl Med. 1992 Jan;17(1):61-4. No abstract available. Rivera-Rodriguez JE, Rodriguez AA, Turnbull GL, Moreno AJ. Scintigraphic evaluation with Tc-99m MDP and Ga-67 citrate in a case of pediatric T-cell lymphoma. Clin Nucl Med. 1992 Jan;17(1):61-4. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43715 |
Study title: Bowel visualization on bone scan because of protein losing enteropathy. Roach PJ, Itrato D, Treves ST. Clin Nucl Med. 1994 Dec;19(12):1114-6. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43606 |
Study title: Sympathetic denervation due to neuroblastoma. Roach PJ, Treves ST. Clin Nucl Med. 1994 Nov;19(11):1023-4. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43611 |
Study title: Rohlin M. Diagnostic value of bone scintigraphy in osteomyelitis of the mandible. Oral Surg Oral Med Oral Pathol. 1993 May;75(5):650-7. Rohlin M. Diagnostic value of bone scintigraphy in osteomyelitis of the mandible. Oral Surg Oral Med Oral Pathol. 1993 May;75(5):650-7. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43666 |
Study title: A 9-Week, Randomized, Double-Blind, Placebo-Controlled, fixed-dosage (340 or 425 mg/day), Parallel-Group Study to Evaluate the Efficacy and Safety of Modafinil (Film-Coated Tablet) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder, Including a 2-Week (Blined) Withdrawel Period. |
Active substance: MODAFINIL |
Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls |
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Document reference: 45282 |
Study title: Longhi A et al Fertility in male patients treated with neoadjuvant chemotherapy forOsteosarcoma J Pediatr Hematol Oncol. 2003 Apr;25(4):292-6Longhi A et al Fertility in male patients treated with neoadjuvant chemotherapy forOsteosarcoma J Pediatr Hematol Oncol. 2003 Apr;25(4):292-6 |
Active substance: MITOXANTRONE |
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Document reference: 32141 |
Study title: TO ASSESS THE ANALGESIC EFFICACY OF PIROXICAM 20 MG (1 M) IN A VARIETY OF PAINFUL CONDITIONS WITH ACUTE ONSET IN SPORTS MEDICINE WHICH DO NOT INVOLVE ANY INJURY. |
Active substance: PIROXICAM |
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Document reference: 34331 |
Study title: Unsuspected muscular radionuclide uptake due to chronic muscular injury contracted during sports activity. Roland J, Houben L, Vandevivere J. Clin Nucl Med. 1997 Sep;22(9):632-3. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43544 |
Study title: Sato Y, Nakayama C, Kimoto T, Nakata H, Suzuki K. [Appraisal of the clinical value of bone scintigraphy for benign bone tumors and tumor-like lesions] Rinsho Hoshasen. 1987 Jul;32(7):791-6. Japanese. No abstract available. Sato Y, Nakayama C, Kimoto T, Nakata H, Suzuki K. [Appraisal of the clinical value of bone scintigraphy for benign bone tumors and tumor-like lesions] Rinsho Hoshasen. 1987 Jul;32(7):791-6. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43856 |
Study title: Sato Y, Nakayama C, Nakata H, Suzuki K. [Bone scintigraphy of non-ossifying fibroma] Rinsho Hoshasen. 1988 Feb;33(2):265-9. Japanese. No abstract available. PMID: 3385950 [PubMed - indexed for MEDLINE] Sato Y, Nakayama C, Nakata H, Suzuki K. [Bone scintigraphy of non-ossifying fibroma] Rinsho Hoshasen. 1988 Feb;33(2):265-9. Japanese. No abstract available. PMID: 3385950 [PubMed - indexed for MEDLINE] |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43827 |
Study title: Schallen E, De Odorico I, Shapiro B. Scintigraphy of proximal femoral focal deficiency. Clin Nucl Med. 1997 Oct;22(10):730-2. No abstract available. Schallen E, De Odorico I, Shapiro B. Scintigraphy of proximal femoral focal deficiency. Clin Nucl Med. 1997 Oct;22(10):730-2. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43542 |
Study title: Schauwecker DS, Park HM, Mock BH, Burt RW, Kernick CB, Ruoff AC 3rd, Sinn HJ, Wellman HN. Evaluation of complicating osteomyelitis with Tc-99m MDP, In-111 granulocytes, and Ga-67 citrate. J Nucl Med. 1984 Aug;25(8):849-53. Schauwecker DS, Park HM, Mock BH, Burt RW, Kernick CB, Ruoff AC 3rd, Sinn HJ, Wellman HN. Evaluation of complicating osteomyelitis with Tc-99m MDP, In-111 granulocytes, and Ga-67 citrate. J Nucl Med. 1984 Aug;25(8):849-53. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43989 |
Study title: Schettini F, Mele M, De Mattia D, Falcone G, D'Addabbo A. Bone metabolism in thalassemia major. J Pediatr. 1987 Jul;111(1):158. No abstract available. Schettini F, Mele M, De Mattia D, Falcone G, D'Addabbo A. Bone metabolism in thalassemia major. J Pediatr. 1987 Jul;111(1):158. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43857 |
Study title: A 9-Week, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dosage (up to 425 mg/day), Parallel-Group Study to Evaluate the Efficacy and Safety of Modafinil (Film-Coated Tablet) in Children with Attention-Deficit/Hyperactivity Disorder. |
Active substance: MODAFINIL |
Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls |
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Document reference: 45281 |
Study title: A 9-Week, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dosage (up to 425 mg/day), Parallel-Group Study to Evaluate the Efficacy and Safety of Modafinil (Film-Coated Tablet) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder. |
Active substance: MODAFINIL |
Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication-Modafinil.xls |
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Document reference: 45283 |
Study title: EFFICACY OF FELDENE AS AN ANTIPYRETIC ANALGESIC IN ADJUVANT ADMINISTRATION WITH ANTIMALARIAL IN THE MANAGEMENT OF MALARIAL BODY |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34490 |
Study title: TO COMPARE EFFICACY OF PIROXICAM IM AND NOVALGIN IM IN THE PROMOTION OF ANALGESIA AND WOUND HEALING IN PATIENTS AFTER ABDOMINAL SURGERY. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34491 |
Study title: TO EVALUATE CLINICAL EFFICACY AND SAFETY OF PIROXICAM IN THE TREATMENT OF PRIMARY DYSMENORRHEA. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34444 |
Study title: TO EVALUATE PIROXICAM SUPPOSITORIES FOR THE TREATMENT OF OSTEOARTHRITIS COMPARED TO A COMBINATION OF SUPPOSITORIES AND TABLETS OF DICLOFENAC. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34478 |
Study title: TO EVALUATE THE ANALGESIC AND ANTIINFLAMATORY EFFECT OF PIROXICAM IN PATIENTS WITH GONBARTHROSIS. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34479 |
Study title: TO EVALUATE THE EFFECT OF PIROXICAM IN THE COURSE OF TREATMENT ASSOCIATED WITH SYMPTOMATIC VIRAL PHARYNGITIS |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34480 |
Study title: TO EVALUATE THE EFFECTIVENESS AND SAFETY OF INJECTABLE PIROXICAM IN THE MANAGEMENT OF POST-OPERATIVE PAIN. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34362 |
Study title: TO EVALUATE THE EFFICACY AND SAFETY OF PIROXICAM IN THE TREATMENT OF JEUVENILE RHEUMATOID ARTHITIS |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34409 |
Study title: Clinical efficacy and tolerance of various regenit preparations |
Active substance: PREDNICARBATE |
Study summary document link (including results): Prednicarbate STUDY Orfanos.xls |
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Document reference: 48013 |
Study title: A 16-week, randomized, multi-center, parallel- group, pimecrolimus-blinded, controlled study (4 week treatment period followed by a 12 week observational period) to evaluate the safety of concomitant use of ASM981 (pimecrolimus) cream 1% (BID) plus topical corticosteroids (BID) for the treatment of severe atopic dermatitis in patients 2 to 17 years of age |
Active substance: PIMECROLIMUS |
Study summary document link (including results): ASM981C2439 Art45 listing 2011.xls |
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Document reference: 34090 |
Study title: Whallett A, Evans N, Bradley S, Jobanputra P. Isotope bone scans: an assessment of their diagnostic use in polyarticular pain of uncertain origin. Ann Rheum Dis. 2003 Aug;62(8):784-5. No abstract available. Whallett A, Evans N, Bradley S, Jobanputra P. Isotope bone scans: an assessment of their diagnostic use in polyarticular pain of uncertain origin. Ann Rheum Dis. 2003 Aug;62(8):784-5. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43416 |
Study title: Esomeprazole Magnesium: A Repeat-Dose Toxicity Study with Up to 3 Months’ Oral (Gavage) Administration in the Neonatal Beagle Dog (with Emphasis on Gastric ECL-Cell Morphology and Toxicokinetics). AstraZeneca R&D Södertälje, Safety Assessment, Sweden (Ch |
Active substance: ESOMEPRAZOLE |
Study summary document link (including results): |
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Document reference: 26608 |
Study title: Clinical evaluation of trimethoprim-containing ophthalmic solutions in humans.Lamberts DW, Buka T, Knowlton GM. Am J Ophthalmol. 1984 Jul 15;98(1):11-6.Clinical evaluation of trimethoprim-containing ophthalmic solutions in humans.Lamberts DW, Buka T, Knowlton GM. Am J Ophthalmol. 1984 Jul 15;98(1):11-6. |
Active substance: POLYMYXIN B AND TRIMETHOPRIM |
Study summary document link (including results): Clinical evaluation of trimethoprim-containing.pdf |
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Document reference: 34584 |
Study title: Metwally A. Impact of drug dosage and brand on bioavailability and efficacy of Praziquantel. Pharmacol Res 1995; 31 (1): 53-59.Metwally A. Impact of drug dosage and brand on bioavailability and efficacy of Praziquantel. Pharmacol Res 1995; 31 (1): 53-59. |
Active substance: PRAZIQUANTEL |
Study summary document link (including results): |
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Document reference: 34645 |
Study title: Evaluation of efficacy and tolerance of prednicarbate 0.25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses. |
Active substance: PREDNICARBATE |
Study summary document link (including results): Prednicarbate STUDY Drebinger 405DT.xls |
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Document reference: 48010 |
Study title: Evaluation of efficacy and tolerance of prednicarbate 0.25% (aqueous cream, emollient cream, fatty ointment) in patients suffering from corticosteroid responsive dermatoses. |
Active substance: PREDNICARBATE |
Study summary document link (including results): Prednicarbate STUDY Drebinger 402DT.xls |
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Document reference: 48011 |
Study title: Klinisches gutachten - 3.4 Wirksamkeit nephrotischen syndrome (page 26) - Studie 65: kinder mit lipoid nephrose - Dr. Drebinger - 03/10/1980 |
Active substance: PIRETANIDE |
Study summary document link (including results): |
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Document reference: 34299 |
Study title: Therapeutisch Erprobung - 2.6.4: Indikation nephrotisches syndrom (pages 1307 to 1380) - Studie 65 : Clinical assessment of HOE118 in children with nephrotic syndrom - Grünberg J - No date |
Active substance: PIRETANIDE |
Study summary document link (including results): |
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Document reference: 34300 |
Study title: Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43504 |
Study title: Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. Winderen M, Stenwig AE, Solheim OP, Saeter G, Aas M. Dynamic bone scintigraphy for evaluation of tumor response after preoperative chemotherapy. A retrospective study of osteosarcoma and Ewing's sarcoma patients. Acta Orthop Scand Suppl. 1999 Jun;285:11-7. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44159 |
Study title: Manfrini M, Rimondi E, Bruno A, Capanna R, Albisinni U, Picci P, Bacci G, Gaiani L, Tarozzi C. Total body bone scan in the evaluation of tumor response to preoperative chemotherapy in the treatment of osteosarcoma. Chir Organi Mov. 1990 Oct-Dec;75(4):325-30. English, Italian. Manfrini M, Rimondi E, Bruno A, Capanna R, Albisinni U, Picci P, Bacci G, Gaiani L, Tarozzi C. Total body bone scan in the evaluation of tumor response to preoperative chemotherapy in the treatment of osteosarcoma. Chir Organi Mov. 1990 Oct-Dec;75(4):325-30. English, Italian. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44175 |
Study title: Marchandise X, Dhellemmes P, Pellerin P, Dujardin MH. [Evaluation of scintigraphy of the skull. Apropos of 84 cases of craniostenosis] Ann Radiol (Paris). 1983 Sep-Oct;26(6):505-9. French. No abstract available. Marchandise X, Dhellemmes P, Pellerin P, Dujardin MH. [Evaluation of scintigraphy of the skull. Apropos of 84 cases of craniostenosis] Ann Radiol (Paris). 1983 Sep-Oct;26(6):505-9. French. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 44029 |
Study title: Piracetam no controle dos disturbios neurologicos da intoxicacao aguda por anticonvulsivantes. 1. difenilidantoina. |
Active substance: PIRACETAM |
Study summary document link (including results): ARCP92F2521 - Piracetam.pdf |
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Document reference: 45906 |
Study title: Prophylaxis of sickle-cell vaso-occlusive crises with oral piracetam. |
Active substance: PIRACETAM |
Study summary document link (including results): DE82J022P - Piracetam.pdf |
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Document reference: 45923 |
Study title: Comparison of the visual analogue scale (VAS) and Smiley Analog Scale (SAS) for evaluation of pain in children. Pain World Congress 1984, Seattle. Raven, New York, p.25 Comparison of the visual analogue scale (VAS) and Smiley Analog Scale (SAS) for evaluation of pain in children. Pain World Congress 1984, Seattle. Raven, New York, p.25 |
Active substance: PIRITRAMIDE |
Study summary document link (including results): pothmann_piritramide.pdf |
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Document reference: 34302 |
Study title: A CLINICAL EVALUATION OF FELDENE -- SUPPOSITORY IN PATIENTS WITH RHEUMATOID ARTHRITIS |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34305 |
Study title: Variant pathogenetic therapy in the acute phase of hypoxic-traumatic brain damage in immature children. |
Active substance: PIRACETAM |
Study summary document link (including results): DRU87G074P - Piracetam.pdf |
View full study record |
Document reference: 46018 |
Study title: Martelli H et al Conservative treatment for girls with nonmetastatic rhabdomyosarcoma of thegenital tract: A report from the Study Committee of the International Society of Pediatric Oncology J Clin Oncol. 1999 Jul;17(7):2117-22. ReviewMartelli H et al Conservative treatment for girls with nonmetastatic rhabdomyosarcoma of thegenital tract: A report from the Study Committee of the International Society of Pediatric Oncology J Clin Oncol. 1999 Jul;17(7):2117-22. Review |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32147 |
Study title: Mastrangelo S et al. Treatment of advanced neuroblastoma: feasibility and therapeutic potential of a novel approach combining 131-I-MIBG and multiple drug chemotherapy. Br J Cancer. 2001 Feb;84(4):460-4Mastrangelo S et al. Treatment of advanced neuroblastoma: feasibility and therapeutic potential of a novel approach combining 131-I-MIBG and multiple drug chemotherapy. Br J Cancer. 2001 Feb;84(4):460-4 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32239 |
Study title: Marymont JV. Comparative imaging. Massive osteolysis (Gorham's syndrome, disappearing bone disease). Clin Nucl Med. 1987 Feb;12(2):153-4. No abstract available. Marymont JV. Comparative imaging. Massive osteolysis (Gorham's syndrome, disappearing bone disease). Clin Nucl Med. 1987 Feb;12(2):153-4. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43873 |
Study title: "Cold spots" in pediatric bone imaging. Rosovsky M, Goldfarb CR, Finestone H, Ongseng F. Semin Nucl Med. 1994 Apr;24(2):184-6. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43628 |
Study title: Rypens F, Gevenois PA, Struyven J. Multifocal Ewing's sarcoma. J Belge Radiol. 1994 Oct;77(5):222. No abstract available. Rypens F, Gevenois PA, Struyven J. Multifocal Ewing's sarcoma. J Belge Radiol. 1994 Oct;77(5):222. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43612 |
Study title: The value of FDG-PET in the detection, grading and response to therapy of soft tissue and bone sarcomas; a systematic review and meta-analysis. CANCER TREATMENT REVIEWS (2004) 30, 83–101. E. Bastiaanneta, H. Groenb, P.L. Jagerc, D.C.P. Cobbenc, W.T.A. van der Graafd, W. Vaalburgc, H.J. Hoekstraa,* |
Active substance: Steripet |
Study summary document link (including results): bastiaannet-2004.pdf |
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Document reference: 48726 |
Study title: McTiernan A et al A phase I/II study of doxorubicin, ifosfamide, etoposide and interval methotrexate in patients with poor prognosis osteosarcoma Pediatr Blood Cancer. 2006 Mar;46(3):345-50McTiernan A et al A phase I/II study of doxorubicin, ifosfamide, etoposide and interval methotrexate in patients with poor prognosis osteosarcoma Pediatr Blood Cancer. 2006 Mar;46(3):345-50 |
Active substance: MITOXANTRONE |
Study summary document link (including results): |
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Document reference: 32131 |
Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF INTRAMUSCULAR PIROXICAM IN ACUTE MUSCULOSKELETAL DISORDERS WHEN ADMINISTERED AS A LOADING DOSE OF 40 MG PER DAY FOR 2 DAYS, FOLLOWED BY 20 MG PER DAY, IM FOR 3 DAYS AND ORAL PIROXICAM ON SUBSEQUENT DAYS. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34474 |
Study title: TO EVALUATE THE EFFICACY AND TOLERATION OF PARENTAL PIROXICAM IN ACUTE MUSCULOSKELETAL DISORDERS WHEN ADMINISTERED AS A LOADING DOSE OF 40 MG STARTING FOR TWO DAYS, FOLLOWED BY 20 MG INTRAMUSCULAR OR ORAL. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34492 |
Study title: TO EVALUATE THE LONG TERM EFFECTS OF TUBAL MORPHOLOGY AND FUNCTION AFTER PUD IN PATIENTS TREATED DURING THE ACUTE EPISODE WITH EITHER DOXYCYCLINE PLUS TINIDAZOLE PLUS PIROXICAM OR PLACEBO. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34462 |
Study title: TO MEASURE THE ELIMINATION HALF-LIFE (T1/2) OF PIROXICAM AFTER ITS STEADY KINETIC STATE HAS BEEN ACHIEVED IN CHILDREN WITH JRA. VALUES FOR VOLUME OF DISTRIBUTION AND CLEARANCE CAN THEN BE CALCULATED. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34466 |
Study title: Sahin M, Bernay I, Basoglu T, Canturk F. Comparison of Tc-99m MDP, Tc-99m HSA and Tc-99m HIG uptake in rheumatoid arthritis and its variants. Ann Nucl Med. 1999 Dec;13(6):389-95. Sahin M, Bernay I, Basoglu T, Canturk F. Comparison of Tc-99m MDP, Tc-99m HSA and Tc-99m HIG uptake in rheumatoid arthritis and its variants. Ann Nucl Med. 1999 Dec;13(6):389-95. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43497 |
Study title: Saito S, Inoue A, Ono K. Intramedullary haemorrhage as a possible cause of avascular necrosis of the femoral head. The histology of 16 femoral heads at the silent stage. J Bone Joint Surg Br. 1987 May;69(3):346-51. Saito S, Inoue A, Ono K. Intramedullary haemorrhage as a possible cause of avascular necrosis of the femoral head. The histology of 16 femoral heads at the silent stage. J Bone Joint Surg Br. 1987 May;69(3):346-51. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43864 |
Study title: Segall GM, Gurevich N. Uterine blush in multiphase imaging. J Nucl Med. 1986 Sep;27(9):1500-1. No abstract available. Segall GM, Gurevich N. Uterine blush in multiphase imaging. J Nucl Med. 1986 Sep;27(9):1500-1. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43896 |
Study title: Senda K, Itoh S. Evaluation of diffusely high uptake by the calvaria in bone scintigraphy. Ann Nucl Med. 1987 Sep;1(1):23-6. Senda K, Itoh S. Evaluation of diffusely high uptake by the calvaria in bone scintigraphy. Ann Nucl Med. 1987 Sep;1(1):23-6. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43851 |
Study title: (99m)Tc-MDP scintigraphic findings in children with leukemia: value of early and delayed whole-body imaging. Shalaby-Rana E, Majd M. J Nucl Med. 2001 Jun;42(6):878-83. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43452 |
Study title: Shanley DJ, Buckner AB, Alexander HG. Unusual pelvic activity found on bone scan. Clin Nucl Med. 1991 Jun;16(6):453-4. No abstract available. Shanley DJ, Buckner AB, Alexander HG. Unusual pelvic activity found on bone scan. Clin Nucl Med. 1991 Jun;16(6):453-4. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43735 |
Study title: Shanley DJ, Vassallo CJ, Buckner AB. Sternoclavicular pyarthrosis demonstrated on bone scan. Correlation with CT and MRI. Clin Nucl Med. 1991 Oct;16(10):786-7. No abstract available. Shanley DJ, Vassallo CJ, Buckner AB. Sternoclavicular pyarthrosis demonstrated on bone scan. Correlation with CT and MRI. Clin Nucl Med. 1991 Oct;16(10):786-7. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43727 |
Study title: Uchida Y, Minoshima S, Kawata T, Motoori K, Nakano K, Kazama T, et al.. Diagnostic value of FDG PET and salivary gland scintigraphy for parotid tumors. [uchida-2005]Clin Nucl Med. 2005 Mar;30(3):170-6. Uchida Y 2005 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48706 |
Study title: EFFICACY OF PIROXICAM TO BE EVALUATED IN PATIENTS WITH ARTHROSIS OF KNEW/OR HIP, OR BURSITIS AND /OR TENDINITIS OF ELBOW OR SHOULDER |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34335 |
Study title: EFFICACY, TOLERATION AND ACCEPTABILITY OF FELDENE IN A VARIETY OF A.M.S.D. LIKE TENNIS ELBOW, FROZEN SHOULDER, TENDINITIS, BURSITIS, ETC. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34483 |
Study title: EFFICACY, TOLERATION AND ACCEPTABILITY OF FELDENE IN A VARIETY OF AMSD'S LIKE TENNIS ELBOW, TENDINITIS, BURSITIS, GOUT ETC. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34489 |
Study title: EVALUATE EFFICACY AND TOLERATION OF PIROXICAM ON RATE OF SYMPTOMATIC RECOVERY IN ACUTE P. FALCIPARUM MALARIAL ATTACK AGAINST THOSE OF ASA AND TYLENOL. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34493 |
Study title: EVALUATE THE PAIN RELIEVING EFFECT OF PIROXICAM COMBINED WITH EPIDURAL MORPHINE AFTER MAJOR ABDOMINAL SURGERY. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34369 |
Study title: EVALUATION OF THE EFFICACY AND SAFETY OF FELDENE 20 MG INTRAMUSCULAR IN THE OSTEOARTICULAR ACUTE ATTACKS DURING SICKLE CELL DISEASE. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34385 |
Study title: EVALUATION OF THE EFFICACY AND TOLERATION OF PIROXICAM AS ADJUVANT THERAPY IN THE TREATMENT OF THE PAIN-DYSFUNCTION SYNDROME OF THE TEMPOROMANDIBULAR JOINT. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34340 |
Study title: EXTENSIVE WORLDWIDE STUDIES TO DISCOVER EVEN RARE SIDE EFFECTS BY MEANS OF LHIGH PATIENT NUMBERS. ALSO IF ONE CAPSULE OF PIROXICAM 20 MG WOULD BE ADVANTAGIOUS TO 2 CAPS OF 10 MG. |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34367 |
Study title: LARGE SCALE MULTICENTRIC EVALUATION OF EFFICACY AND TOLERABILITY OF PRX GEL 0.5% IN THE TREATMENT OF AMEAS |
Active substance: PIROXICAM |
Study summary document link (including results): |
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Document reference: 34351 |
Study title: Topiramate, carbamazepine and valproate monotherapy: double-blind comparison in children with newly diagnosed epilepsy. JM Wheless, J Child Neurol 2004;19:135-141 in CES EXPCRC-CES0296-EN-E01 Topiramate, carbamazepine and valproate monotherapy: double-blind comparison in children with newly diagnosed epilepsy. JM Wheless, J Child Neurol 2004;19:135-141 in CES EXPCRC-CES0296-EN-E01 |
Active substance: URINARY CONCREMENT SOLVENTS |
Study summary document link (including results): |
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Document reference: 39154 |
Study title: Evaluación del efecto de una vacuna polivalente neumocócica en la incidencia de la carga nasofaríngea de S.pneumoniae y de Otitis media aguda . (U.S) |
Active substance: Vacuna conjugada (adsorbida) frente al oligosacárido meningocócico del serogrupo C |
Study summary document link (including results): |
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Document reference: 40296 |
Study title: A Double-blind, Multi-centre Study Comparing Oral Valaciclovir and Aciclovir for the Suppression of CMV Infection and Disease Following Allogeneic Bone Marrow Transplantation |
Active substance: VALACICLOVIR |
Study summary document link (including results): Valaciclovir-123-016-ICHE3.pdf |
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Document reference: 47355 |
Study title: A multicentre, randomised, double-blind, parallel, placebo controlled study of two dosing regimens of valaciclovir compared to placebo for the prevention/blockage of the progression of the cold sore lesion beyond the papular stage. |
Active substance: VALACICLOVIR |
Study summary document link (including results): Valaciclovir-HS230028-ICHE3.pdf |
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Document reference: 45427 |
Study title: A multicentre, randomised, double-blind, parallel, placebo-controlled study of two dosing regimens of valaciclovir compared to placebo for the reduction in length of cold sore episodes. |
Active substance: VALACICLOVIR |
Study summary document link (including results): Valaciclovir-HS230027-ICHE3.pdf |
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Document reference: 45426 |
Study title: A randomised, double-blind, multicentre study to evaluate the efficacy of valaciclovir in episodic treatment of recurrent facial herpes simplex virus (HSV) infection. |
Active substance: VALACICLOVIR |
Study summary document link (including results): Study HS240011 Valaciclovir.xls |
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Document reference: 45428 |
Study title: A study to investigate the steady state pharmacokinetics of oral Valaciclovir (Valtrex) in immunocompromised children |
Active substance: VALACICLOVIR |
Study summary document link (including results): Valaciclovir-HS2B4005-ICHE3.pdf |
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Document reference: 45429 |
Study title: An open-label, multiple-dose, multicenter, pharmacokinetic safety and tolerability study of valaciclovir oral suspension in infants and children with HSV infection |
Active substance: VALACICLOVIR |
Study summary document link (including results): Valaciclovir-HS210915-ICHE3.pdf |
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Document reference: 45424 |
Study title: "A parallel group study comparing oral adjuctive vigabatrin with placebo in children with uncontrolled complex partial seizures - Valentine C, Mettert N, Mosier M, Michon AM, and the Vigabatrin protocol 221 investigative cohort - 1998 (Epilepsia In press (abstract) 1998) Publication in Consolidated Responses to Questions raised in Article 12 Referral Procedure - 11/1998" |
Active substance: VIGABATRIN |
Study summary document link (including results): |
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Document reference: 39386 |
Study title: A multicenter, open-label, single-dose study to evaluate the pharmacokinetics (i.e. 24 hour pharmacokinetic sampling period) of valsartan given as an oral suspension in pediatric patients 1 year to 16 years of age with hypertension.DOI: 10.1177/0091270008329547 Journal publication: Journal Clinical Pharmacology 2009;49:235-241 |
Active substance: VALSARTAN |
Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2305_2.xls |
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Document reference: 47269 |
Study title: A multicenter, open-label, single-dose study to evaluate the pharmacokinetics (i.e. 24 hour pharmacokinetic sampling period) of valsartan given as an oral suspension in pediatric patients 1 year to 16 years of age with hypertension. |
Active substance: VALSARTAN |
Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2305_2.xls |
View full study record |
Document reference: 48168 |
Study title: An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of Venlafaxine ER in Pediatric Patients |
Active substance: Venlafaxine |
Study summary document link (including results): 0600B1-169-US EMA Pediatrics Web Synopsis.pdf |
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Document reference: 47931 |
Study title: In vitro fluoride uptake, distribution and retention by human enamel after 1- and 24-hour application of various topical fluoride agents. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42404 |
Study title: In vitro fluoride uptake, distribution and retention by human enamel after 1- and 24-hour application of various topical fluoride agents. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42517 |
Study title: Influence of F--releasing varnishes on the acid resistance of enamel. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42337 |
Study title: Non-comparative, prospective and observational multicenter study to detect early visual field defects, their frequency and clinical course in first-time vigabatrin (Sabril®) treatment for refractory partial epilepsy (CANADIAN VIGABATRIN STUDY). |
Active substance: VIGABATRIN |
Study summary document link (including results): Vigabatrin-Study 4.pdf |
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Document reference: 39393 |
Study title: Open, multicentre study of the prevalence, incidence and clinical course of visual field defects in adults and children with refractory partial epilepsy treated with antiepileptic drugs. |
Active substance: VIGABATRIN |
Study summary document link (including results): Vigabatrin-Study 2.pdf |
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Document reference: 47305 |
Study title: A phase I evaluation of oral and intravenous vinorelbine tartrate in Paediatric Cancer Patients |
Active substance: VINORELBINE |
Study summary document link (including results): |
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Document reference: 39399 |
Study title: "Safety of inactivated split-virion influenza vaccine administered by the intradermal route in healthy children" |
Active substance: Virus de la gripe fraccionados |
Study summary document link (including results): |
View full study record |
Document reference: 45261 |
Study title: An Open-Label, Multiple-Dose, Multicenter, Pharmacokinetic Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children with VZV Infection |
Active substance: VALACICLOVIR |
Study summary document link (including results): Valaciclovir-HS210916-ICHE3.pdf |
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Document reference: 45425 |
Study title: An open-label, single-dose, multicenter, pharmacokinetic, safety and tolerability study of valaciclovir oral suspension in infants and children. |
Active substance: VALACICLOVIR |
Study summary document link (including results): Valaciclovir-HS210914-ICHE3.pdf |
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Document reference: 45423 |
Study title: Evaluation of efficacy and safety of biosynthetic human growth hormone (Norditropin®). An open multicentre study |
Active substance: Somatropin |
Study summary document link (including results): H-GHV-001-GHD_Norditropin.pdf |
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Document reference: 41768 |
Study title: Evaluation of Growth Promoting Effect and Safety of Growth Hormone in Achondroplasia |
Active substance: Somatropin |
Study summary document link (including results): Somatropin - B9R-JE-6001 CTR Summary.pdf |
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Document reference: 41635 |
Study title: Evaluation of knee-mometry as a method of growth velocity control in growth retarded children undergoing one year of growth hormone treatment |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41782 |
Study title: Strenge-Hesse Postmarkting surveillance study (evaluation of 154 Legalon-SIL-case reports,18 children) 1983-1992 Internal Report; Internal Report, Strenge-Hesse, March 1996 |
Active substance: Silibinine dihydrogen succinate, disodium |
Study summary document link (including results): |
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Document reference: 40194 |
Study title: Protocol A: The Effects of Biosynthetic Human Growth Hormone Treatment in the Management of Children with Familial Short Stature. Protocol B: A Comparative Evaluation of Growth Hormone, anabolic steroids and a combinationof the two in stimulating the Grow |
Active substance: Somatropin |
Study summary document link (including results): GHRETARD-BPD-8-9-10-UK_Norditropin.pdf |
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Document reference: 41779 |
Study title: An Open-Label, Uncontrolled Pharmacokinetic and Clinical Evaluation Study of Valaciclovir Hydrochloride in Children with Chickenpox. |
Active substance: VALACICLOVIR |
Study summary document link (including results): Valaciclovir-HS2101951-ICHE3.pdf |
View full study record |
Document reference: 45422 |
Study title: Pharmacokinetics and Safety of valaciclovir in children with Epstein-Barr virus illness; Drugs R&D, 2002: 3(6), SimonPharmacokinetics and Safety of valaciclovir in children with Epstein-Barr virus illness; Drugs R&D, 2002: 3(6), Simon |
Active substance: VALACICLOVIR |
Study summary document link (including results): |
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Document reference: 45421 |
Study title: Pharmacokinetics of acyclovir in immunocompromised children with leukopenia and mucositis after chemotherapy: Can intravenous acyclovir be substituted by oral valacyclovir?Med Pediatr Oncol 2002:38:240-246, EksborgPharmacokinetics of acyclovir in immunocompromised children with leukopenia and mucositis after chemotherapy: Can intravenous acyclovir be substituted by oral valacyclovir?Med Pediatr Oncol 2002:38:240-246, Eksborg |
Active substance: VALACICLOVIR |
Study summary document link (including results): |
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Document reference: 45430 |
Study title: To estimate the survival of bone marrow transplant (BMT) subjects randomized to receive cytomegalovirus (CMV) prophylaxis with intravenous (IV) acyclovir (ACV) followed by either oral valaciclovir (VACV) or IV ganciclovir (GCV). |
Active substance: VALACICLOVIR |
Study summary document link (including results): Study 123-039 (HS2A3005) Valaciclovir.xls |
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Document reference: 47356 |
Study title: Clinical Protocol for a Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel Group Study to Compare the Efficacy and Tolerability of Valdecoxib vs. Tramadol in Treatment of Acute Ankle Sprains |
Active substance: Valdecoxib |
Study summary document link (including results): |
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Document reference: 47444 |
Study title: Post-marketing surveillance trial evaluating efficacy and tolerability of a valerian root extract in 55 children. |
Active substance: Valerian root extract 6.15:1 (HERB) |
Study summary document link (including results): |
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Document reference: 40297 |
Study title: Francis AJ, Dempster RJ. Effect of valerian, Valeriana edulis, on sleep difficulties in children with intellectual deficits: randomised trial. Phytomedicine. 2002 May;9(4):273-9. |
Active substance: Valeriana dry extract |
Study summary document link (including results): |
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Document reference: 40299 |
Study title: Müller SF, Klement S. A combination of valerian and lemon balm is effective in the treatment of restlessness and dyssomnia in children. Phytomedicine. 2006 Jun;13(6):383-7. Epub 2006 Feb 17. |
Active substance: Valeriana dry extract |
Study summary document link (including results): |
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Document reference: 40298 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Valerianaheel (drops) [AWB-AT] |
Active substance: Valeriana Heel |
Study summary document link (including results): |
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Document reference: 39769 |
Study title: An open-label, multiple-dose, multicenter, pharmacokinetic safety and tolerability study of valaciclovir oral suspension in infants and children with HSV infection |
Active substance: VALGACICLOVIR |
Study summary document link (including results): |
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Document reference: 45433 |
Study title: An Open-Label, Multiple-Dose, Multicenter, Pharmacokinetic Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children with VZV Infection |
Active substance: VALGACICLOVIR |
Study summary document link (including results): |
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Document reference: 45434 |
Study title: An open-label, single-dose, multicenter, pharmacokinetic, safety and tolerability study of valaciclovir oral suspension in infants and children. |
Active substance: VALGACICLOVIR |
Study summary document link (including results): |
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Document reference: 45432 |
Study title: An Open-Label, Uncontrolled Pharmacokinetic and Clinical Evaluation Study of Valaciclovir Hydrochloride in Children with Chickenpox. |
Active substance: VALGACICLOVIR |
Study summary document link (including results): |
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Document reference: 45431 |
Study title: A clinical study of 57 children with fetal anticonvulsant syndromes. - Moore et al. - J Med Genet 2000;37:489-497. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45435 |
Study title: A comparative review of the adverse effects of anticonvulsants in children with epilepsy. - Wallace SJ. - Drug safety 1996; 15(6): 378-393. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45436 |
Study title: "Evaluation of safety and immunogenicity of inactivated flu vaccine in children with underlying disease" |
Active substance: Virus de la gripe fraccionados, inactivados que contienen antígenos equivalentes a las cepas recomendadas por la OMS (hemisferio Norte) y la decisión de la Unión Europea para cada campaña de vacunación [inactivated influenza split virion vaccine (Triton X 100)] |
Study summary document link (including results): |
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Document reference: 41459 |
Study title: Evaluation of safety and immunogenicity of inactivated flu vaccine in children with underlying disease |
Active substance: Virus de la gripe fraccionados, inactivados que contienen antígenos equivalentes a las cepas recomendadas por la OMS (hemisferio Norte) y la decisión de la Unión Europea para cada campaña de vacunación [inactivated influenza split virion vaccine (Triton X 100)] |
Study summary document link (including results): |
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Document reference: 41460 |
Study title: A cohort study of childhood hypertrophic cardiomyopathy: improved survival following high−dose beta−adrenoceptor antagonist treatment.Ostman−Smith I, Wettrell G, Riesenfeld T. Journal of the American College of Cardiology, 15 Nov 1999, vol. 34, no. 6, p.1813−22, A cohort study of childhood hypertrophic cardiomyopathy: improved survival following high−dose beta−adrenoceptor antagonist treatment.Ostman−Smith I, Wettrell G, Riesenfeld T. Journal of the American College of Cardiology, 15 Nov 1999, vol. 34, no. 6, p.1813−22, |
Active substance: VERAPAMIL |
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Document reference: 45540 |
Study title: Alternatives in drug treatment of chronic paroxysmal hemicrania.Evers S, Husstedt IW. Headache, Jul−Aug 1996, vol. 36, no. 7, p. 429−32, Alternatives in drug treatment of chronic paroxysmal hemicrania.Evers S, Husstedt IW. Headache, Jul−Aug 1996, vol. 36, no. 7, p. 429−32, |
Active substance: VERAPAMIL |
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Document reference: 45546 |
Study title: Antagonisty kal'tsiia v lechenii nefrogennoi gipertenzii. (Calcium antagonists in the treatment of nephrogenic hypertension).Antonchenko IV, Tareeva IE, Kutyrina IM, Galstian GM, Rogov VA. Klinicheskaia meditsina, Aug 1990, vol. 68, no. 8, p. 52−6,Antagonisty kal'tsiia v lechenii nefrogennoi gipertenzii. (Calcium antagonists in the treatment of nephrogenic hypertension).Antonchenko IV, Tareeva IE, Kutyrina IM, Galstian GM, Rogov VA. Klinicheskaia meditsina, Aug 1990, vol. 68, no. 8, p. 52−6, |
Active substance: VERAPAMIL |
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Document reference: 45555 |
Study title: Antihypertensive activity of verapamil: impact of dietary sodium. The VERSAL Study Group.Antihypertensive activity of verapamil: impact of dietary sodium. The VERSAL Study Group. |
Active substance: VERAPAMIL |
Study summary document link (including results): |
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Document reference: 45550 |
Study title: Assessment of blindness in the Danish Verapamil Infarction Trial II (DAVIT II). Danish Study Group on Verapamil in Myocardial Infarction.Jespersen CM. European journal of clinical pharmacology, 1990, vol. 39, no. 1, p. 75−6, Assessment of blindness in the Danish Verapamil Infarction Trial II (DAVIT II). Danish Study Group on Verapamil in Myocardial Infarction.Jespersen CM. European journal of clinical pharmacology, 1990, vol. 39, no. 1, p. 75−6, |
Active substance: VERAPAMIL |
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Document reference: 45556 |
Study title: Beta−adrenoblokatory i antagonisti kal'tsiia pri gipertroficheskoi kardiomiopatii. (Beta−adrenergic blockers and calcium antagonists in hypertrophic cardiomyopathy).Korovina EP. Klinicheskaia meditsina, 1998, vol. 76, no. 12, p. 30−5, Beta−adrenoblokatory i antagonisti kal'tsiia pri gipertroficheskoi kardiomiopatii. (Beta−adrenergic blockers and calcium antagonists in hypertrophic cardiomyopathy).Korovina EP. Klinicheskaia meditsina, 1998, vol. 76, no. 12, p. 30−5, |
Active substance: VERAPAMIL |
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Document reference: 45542 |
Study title: Calcium channel blockers and cardiac mortality in the treatment of hypertension: a report from the Department of Health Hypertension Care Computing Project (DHCCP).Bulpitt CJ, Palmer AJ, Beevers DG, Coles EC, Ledingham JG, Petrie JC, Webster J. Journal of human hypertension, Apr 1997, vol. 11, no. 4, p. 205−11, Calcium channel blockers and cardiac mortality in the treatment of hypertension: a report from the Department of Health Hypertension Care Computing Project (DHCCP).Bulpitt CJ, Palmer AJ, Beevers DG, Coles EC, Ledingham JG, Petrie JC, Webster J. Journal of human hypertension, Apr 1997, vol. 11, no. 4, p. 205−11, |
Active substance: VERAPAMIL |
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Document reference: 45543 |
Study title: Calcium channel blockers in cirrhotic patients with portal hypertension.Li D, Lu H, Li X, Quan Q, Li X, Lu W. Chinese medical journal, Nov 1995, vol. 108, no. 11, p. 803−8, Calcium channel blockers in cirrhotic patients with portal hypertension.Li D, Lu H, Li X, Quan Q, Li X, Lu W. Chinese medical journal, Nov 1995, vol. 108, no. 11, p. 803−8, |
Active substance: VERAPAMIL |
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Document reference: 45547 |
Study title: Grüngreiff K./Strenge-Hesse et al. Nutzen der medikamentösen Lebertherpaie in der hausärztlichen Praxis. The value of drug therapy for liver disease in general practice. Die Medizinische Welt 1995; 46(4): 222-227.Grüngreiff K./Strenge-Hesse et al. Nutzen der medikamentösen Lebertherpaie in der hausärztlichen Praxis. The value of drug therapy for liver disease in general practice. Die Medizinische Welt 1995; 46(4): 222-227. |
Active substance: SILYMARIN |
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Document reference: 42173 |
Study title: Fissure sealants versus fluorine varnish on the first permanent molars: economic assessment |
Active substance: SODIUM FLUORIDE |
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Document reference: 42348 |
Study title: Fissure sealants versus fluorine varnish on the first permanent molars: economic assessment |
Active substance: SODIUM FLUORIDE |
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Document reference: 42461 |
Study title: STUDY EVALUATING THE EFFECT OF GENOTROPIN IN PREPUBERTAL SHORT NORMAL CHILDREN |
Active substance: Somatropin |
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Document reference: 41740 |
Study title: Ota FS, Abramo TJ, Maxson RT. Ominous findings in toddlers with increasing abdominal girth: Two unusual cases and a review of the clinical evaluation. Ann Emerg Med. May 1, 2005, 517-23Ota FS, Abramo TJ, Maxson RT. Ominous findings in toddlers with increasing abdominal girth: Two unusual cases and a review of the clinical evaluation. Ann Emerg Med. May 1, 2005, 517-23 |
Active substance: SIMETICONE |
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Document reference: 42182 |
Study title: Final report of the study a double-blind, randomised, controlled, multi-centre safety study of a refrigerator-stable formulation of VARIVAX in healthy 12 to 15 month-old children, X04-VAR-402. : |
Active substance: virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella |
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Document reference: 45265 |
Study title: Bates BYC, Evans PH, Sonko BJ, et al. Biochemical indices and neuromuscular function tests in rural Gambian schoolchildren given a riboflavin, or multivitamin plus iron, supplement. British J of Nutr, 1994:72;601-610.Bates BYC, Evans PH, Sonko BJ, et al. Biochemical indices and neuromuscular function tests in rural Gambian schoolchildren given a riboflavin, or multivitamin plus iron, supplement. British J of Nutr, 1994:72;601-610. |
Active substance: VITAMINS |
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Document reference: 45571 |
Study title: Effect of long-acting garlic tablets "allicor" on the incidence of acute respiratory viral infections in children. Andrianova IV, Sobenin IA, Sereda EV, Borodina LI, Studenikin MI. Ter Arkh. 2003;75(3):53-6.Effect of long-acting garlic tablets "allicor" on the incidence of acute respiratory viral infections in children. Andrianova IV, Sobenin IA, Sereda EV, Borodina LI, Studenikin MI. Ter Arkh. 2003;75(3):53-6. |
Active substance: VITAMINS |
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Document reference: 45569 |
Study title: A multicentre comparative trial of sodium valproate and carbamazepine in paediatric epilepsy. CM Verity Developmental medicine and child neurology,37,97-108, 1995 in CES EXPCRC-CES0002-ENE01 |
Active substance: VALPROIC ACID |
Study summary document link (including results): Valproic Acid STUDY 022-6-133-V1.xls |
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Document reference: 45437 |
Study title: A multicentre comparative trial of sodium valproate and carbamazepine in paediatric epilepsy. CM Verity Developmental medicine and child neurology,37,97-108, 1995 in CES EXPCRC-CES0364-ENE01 |
Active substance: VALPROIC ACID |
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Document reference: 45440 |
Study title: A multicentre comparative trial of sodium valproate and carbamazepine in paediatric epilepsy. CM Verity Developmental medicine and child neurology,37,97-108, 1995 in CES EXPCRC-CES0368-ENE01 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45441 |
Study title: Fluoride clearance of whole saliva in young school children after topical application. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42397 |
Study title: Fluoride clearance of whole saliva in young school children after topical application. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42510 |
Study title: Fluoride concentration in plaque in adolescents after topical application of different fluoride varnishes. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42537 |
Study title: Fluoride concentration in whole saliva and separate gland secretions after topical treatment with three different fluoride varnishes |
Active substance: SODIUM FLUORIDE |
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Document reference: 42434 |
Study title: Fluoride concentration in whole saliva and separate gland secretions after topical treatment with three different fluoride varnishes |
Active substance: SODIUM FLUORIDE |
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Document reference: 42547 |
Study title: Fluoride content of enamel during treatment and 2 years after discontinuation of treatment with fluoride varnishes. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42415 |
Study title: Fluoride content of enamel during treatment and 2 years after discontinuation of treatment with fluoride varnishes. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42528 |
Study title: T. Orłowski - ,,Clinical evaluation of the preparation Salbutamol tablets and syrup" |
Active substance: SALBUTAMOL |
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Document reference: 35553 |
Study title: Simón A et al. The use of gastric ultrasonography in the evaluation of a new antiflatulent preparation in human volunteers. Methods Find Exp Clin Pharmacol. 1985 Jul;7(7):393-8Simón A et al. The use of gastric ultrasonography in the evaluation of a new antiflatulent preparation in human volunteers. Methods Find Exp Clin Pharmacol. 1985 Jul;7(7):393-8 |
Active substance: SIMETICONE |
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Document reference: 42215 |
Study title: Influence of F--releasing varnishes on the acid resistance of enamel. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42450 |
Study title: Intensive fluoride varnish program in Swedish adolescents: economic assessment of a 7-year follow-up study on proximal caries incidence. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42398 |
Study title: Intensive fluoride varnish program in Swedish adolescents: economic assessment of a 7-year follow-up study on proximal caries incidence. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42511 |
Study title: Kinetics of fluorine in deciduous enamel after application of fluoride-containing varnish (Duraphat). |
Active substance: SODIUM FLUORIDE |
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Document reference: 42375 |
Study title: Kinetics of fluorine in deciduous enamel after application of fluoride-containing varnish (Duraphat). |
Active substance: SODIUM FLUORIDE |
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Document reference: 42488 |
Study title: Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179.Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42247 |
Study title: Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179.Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42279 |
Study title: Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179.Leverett DH, Adair SM, Vaughan BW et al. Randomized clinical trail of the effect of prenatal fluoride supplements in preventing dental caries. Caries res 1997; 31: 174-179. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42311 |
Study title: A study of the safety of sodium divalproate (Dépakote®) in adolescents suffering from bipolar disorder in manic, mixed or hypomanic phase |
Active substance: VALPROIC ACID |
Study summary document link (including results): Sodium Valproate-Study 1.pdf |
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Document reference: 47744 |
Study title: Adab et al. Additional educational needs in children born to mothers with epilepsy. J Neurol Neurosurg Psychiatry 2001;70:15-21. |
Active substance: VALPROIC ACID |
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Document reference: 45443 |
Study title: Additional educational needs in children born to mothers with epilepsy. -Adab et al. - J Neurol Neurosurg Psychiatry 2001;70:15-21. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45444 |
Study title: American Academy of Pediatrics. Committee on quality improvement, subcommittee on febrile convulsions. Practice parameter: long-term treatment of the child with simple febrile convulsions. Pediatrics 1999; 103: 1307-1309. |
Active substance: VALPROIC ACID |
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Document reference: 45445 |
Study title: An open-label trial of divalproex in children and adolescents with bipolar disorder - Wagner KD. - 2002 ( J Am Acad Child Adolesc Psychiatry 2002, 41 (10) : 1224-1230 ) |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45446 |
Study title: Antiepileptic drug-induced worsening of seizures in children. - Guerrini R. et al. - Epilepsia 1998; 39 (suppl. 3): S2-S10 |
Active substance: VALPROIC ACID |
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Document reference: 45448 |
Study title: Arpino C et al. Teratogenic effects of antiepileptic drugs: use of an international database on malformations and drug exposure (MADRE). Epilepsia 2000;41(11):1436-43. |
Active substance: VALPROIC ACID |
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Document reference: 45449 |
Study title: Barnes SE et al. Sodium valproate in the treatment of intractable childhood epilepsy. Develop Med Child Neurol 1975;17:175-81. |
Active substance: VALPROIC ACID |
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Document reference: 45450 |
Study title: Baumann RJ. Prevention and management of febrile convulsions. Paedriatr Drugs 2001; 3: 585-592. |
Active substance: VALPROIC ACID |
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Document reference: 45452 |
Study title: Baumann RJ. et al. Treatment of children with simple febrile convulsions: the AAP practice parameter. Pediatr Neurol 2000; 23:11-17. |
Active substance: VALPROIC ACID |
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Document reference: 45451 |
Study title: Benign epilpesies of infancy - Epilepsy: A compehensive Textbook - 1997, p,2267-76 |
Active substance: VALPROIC ACID |
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Document reference: 45453 |
Study title: Berg AT et al. Predictors of recurrent febrile convulsions: a metaanalytic review. J Pediatr 1990; 116: 329-337. |
Active substance: VALPROIC ACID |
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Document reference: 45454 |
Study title: Camfield PR et al. Febrile seizures. In: epileptic syndromes in infancy, childhood and adolescence. J Roger et al editors. John Libbey and Co Ltd publishers. 3rd edition. 2002; chapter 11: 145-152. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45455 |
Study title: A multicentre, open, centrally randomised, parallel group study of the evaluation of the efficacy and tolerance of roxithromycin 5 - 8mg/Kg/day bid versus ceflacor 20mg/Kg/day bid in a 5 to 10 days treatment of lower respiratory tract infections in children - Kotze A. - 06/98 |
Active substance: ROXYTHROMYCIN |
Study summary document link (including results): RU28965D3003.pdf |
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Document reference: 45230 |
Study title: AN OPEN FOLLOW-UP TRIAL EVALUATING THE CLINICAL COURSE OF PATIENTS WITH CYSTIC FIBROSIS AFTER GROWTH HORMONE TREATMENT ENDED WITHIN PHARMACIA CLINICAL TRIAL 307- MET-9002-026 |
Active substance: Somatropin |
Study summary document link (including results): GENOT-9002-079 PhRMA Web Synopsis.pdf |
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Document reference: 41663 |
Study title: An open Multi-center trial evaluating the acceptability and tolerability of a new liquid growth hormone formulation, Norditropin® SimpleXx, by using a new pen system: NordiPenTM with or without NordiPenmateTM |
Active substance: Somatropin |
Study summary document link (including results): GHLiquid-1227_Norditropin.pdf |
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Document reference: 41813 |
Study title: An open multicenter trial evaluating acceptance of the new liquid Norditropin® formulation |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41809 |
Study title: An open randomised multicenter, 2-period crossover trial evaluating acceptance of the new liquid Norditropin® formulation versus the freeze-dried Norditropin® |
Active substance: Somatropin |
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Document reference: 41808 |
Study title: An open randomised multicentre, 2-period crossover trial evaluating acceptance of the new liquid Norditropin® SimpleXx® versus the freeze-dried Norditropin®PenSet® |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41810 |
Study title: An open randomised multicentre, 2-period crossover trial evaluating in GHD children the acceptance of the new liquid Norditropin® Simplexx™ versus the freeze-dried Norditropin® 4 I.U. |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41811 |
Study title: An open randomized, multicentre,2-period crossover trial evaluating accaptance/ convenience and pain perception of the new liquid formulation versus freeze-dried Norditropin® |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41806 |
Study title: AN OPEN SINGLE CENTRE TRIAL EVALUATING THE EFFICACY AND SAFETY OF GENOTROPIN IN SHORT CHILDREN WITH PRADER-WILLI SYNDROME |
Active substance: Somatropin |
Study summary document link (including results): 94-8129-007 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 41671 |
Study title: T. Ortowski - "Clinical evaluation of preparation Salbutamol tablets and syrup" |
Active substance: SALBUTAMOL |
Study summary document link (including results): |
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Document reference: 35554 |
Study title: An open trial to evaluate the efficacy and tolerance of Duofilm in the treatment of warts. |
Active substance: SALICYLIC ACID AND LACTIC ACID |
Study summary document link (including results): Article 45_Ref_C0293_Final for Submission_07Nov2011.xlsx |
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Document reference: 48307 |
Study title: Evaluation of the effectiveness of Solcoseryl Eye-Gel in the treatment of some corneal diseases. |
Active substance: SALICYLIC ACID AND UREA |
Study summary document link (including results): |
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Document reference: 35588 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Vomitusheel (drops) [AWB-AT] |
Active substance: Vomitusheel |
Study summary document link (including results): |
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Document reference: 40309 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Vomitusheel (drops) [AWB-AT] |
Active substance: Vomitusheel - Tropfen |
Study summary document link (including results): |
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Document reference: 40308 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Vomitusheel S (suppositories) [AWB-AT] |
Active substance: Vomitusheel S |
Study summary document link (including results): |
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Document reference: 40310 |
Study title: Camfield PR et al. Treatment of febrile seizures. In: epilepsy: a comprehensive textbook. J Engel and TA Pedley editors. Lippincott-Raven publishers. Philadelphia (USA) 1997; chapter 118: 1305-1309 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45456 |
Study title: Carbamazepine versus valproate montherapy for epilepsy: a meta-analysis - AG Marson - 2002 (Epilepsia 2002;43:505-513) - Publication in CES EXPCRC-CES0640-EN-E01 - |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45457 |
Study title: Cerovac-Cosic N et al. Neurological development of infants born to mothers with juvenile myoclonic epilepsy (JME). Epilepsia 1998;39 (Suppl 2):21. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45459 |
Study title: An open-labeled study evaluating the safety and efficacy of growth hormone therapy in short children with chronic renal insufficiency |
Active substance: Somatropin |
Study summary document link (including results): 91-003 and 91-004 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 41710 |
Study title: A double-Blind, Randomized, Placebo-Controled, Multicenter, Parallel Group Evaluation of the efficacy and Safety of Sertaconazole 2% Cream in Patients with interdigital Tinea Pedis. October 7, 1999 |
Active substance: SERTACONAZOLE |
Study summary document link (including results): Ferrer_ Spain_ Ser-960603.pdf |
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Document reference: 42125 |
Study title: A double-Blind, Randomized, Placebo-Controled, Multicenter, Parallel Group Evaluation of the efficacy and Safety of Sertaconazole 2% Cream in Patients with interdigital Tinea Pedis. January 29, 1999 |
Active substance: SERTACONAZOLE |
Study summary document link (including results): Ferrer_ Spain_ Ser-960602.pdf |
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Document reference: 48114 |
Study title: Van Esso D.; Fajo G.; Losada I., Vilallonga M, Casanovas JM; Clanxet J.; Aliaga A. Clinical Therapeutics 1995; 17:264-269 Sertaconazole in the treatment of paediatric patients with cutaneous dermatophyte infections PMID: 7614526 http://www.ncbi.nlm.nih.gov/pubmed?term=7614526 Van Esso D.; Fajo G.; Losada I., Vilallonga M, Casanovas JM; Clanxet J.; Aliaga A. Clinical Therapeutics 1995; 17:264-269 Sertaconazole in the treatment of paediatric patients with cutaneous dermatophyte infections PMID: 7614526 http://www.ncbi.nlm.nih.gov/pubmed?term=7614526 |
Active substance: SERTACONAZOLE |
Study summary document link (including results): |
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Document reference: 45241 |
Study title: GH THERAPY IN PARTIAL GHD ADOLESCENTS: EVALUATION OF EFFICACY BASED ON BODY COMPOSITION AND COMPARISON OF 2 DIFFERENT DOSES OF GENOTONORM(REGISTERED) OPEN LABEL, RANDOMIZED, COMPARATIVE, CONTROLLED, PARALLEL-GROUP, MULTICENTER PHASE IIIB TRIAL |
Active substance: Somatropin |
Study summary document link (including results): 307-MET-9002-016 (A6281018) PhRMA Web Synopsis.pdf |
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Document reference: 41648 |
Study title: Ball R et al. Stevens-Johnson syndrome and toxic epidermal necrolysis after vaccination: Reports to the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J. March 6, 2001, 219-23Ball R et al. Stevens-Johnson syndrome and toxic epidermal necrolysis after vaccination: Reports to the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J. March 6, 2001, 219-23 |
Active substance: SIMETICONE |
Study summary document link (including results): |
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Document reference: 42188 |
Study title: A single centre, double blind, parallel group, placebo controlled study, to evaluate the effect of inhaled Salmeterol xinafoate (50mcg bd from a Diskhaler) on variations in bronchoconstriction induced by methacholine, in paediatric patients with mild to moderate asthma. Report No. VCL/ME/1998/004 |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Salmeterol-Xinafoate-SLMP03-ICHE3.pdf |
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Document reference: 42058 |
Study title: The growth promoting effect of NN-798 in children with chronic renal failure on conservative therapy. |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41797 |
Study title: Clinical comparative assessment of efficacy, tolerance and toxicity of Dipromal and Depakina in the treatment of epilepsy in children |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45460 |
Study title: Clinical evaluation report - Loiseau - 1980 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45461 |
Study title: Clinical evaluation report - Loiseau - 25.11.1980 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45462 |
Study title: Clinical pharmacokinetics of valproic acid - Zaccara G. Messori A. and al. - 1988 (Clin Pharmacokinet, 15 : 367-89) - Publication in expert report on the clinical documentation - Giudicelli A. - 05/2002 - |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45463 |
Study title: Clinical results obtained during treatment with Depakene conducted in psychiatric hospitals - Beaudouin - No date - Publication 9 in Clinical trials with Depakene - No author - No date - |
Active substance: VALPROIC ACID |
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Document reference: 45464 |
Study title: Clinical trials with a new antiepileptic, sodium dipropylacetate - Dereux and al. - 1967 (Congrès de Psychiatrie et de Neurologie de langue française) Publication 4 in Clinical trials with Depakene - No author - No date |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45465 |
Study title: Committee on quality improvement, subcommittee on febrile convulsions. Practice parameter: long-term treatment of the child with simple febrile convulsions. - American Academy of Pediatrics. - Pediatrics 1999; 103: 1307-1309. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45466 |
Study title: Comparative clinical and pharmacokinetic study of a new slow release versus conventional preparations of valproic acid in children with intractable epilepsy - Braisn and Development, 1992, 14 (5), p.304-308 - Imaizumi T., Izumi T., Fukuyama Y. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45467 |
Study title: Continuous sodium valproate or pheobarbitone in the prevention of simple febrile-Comparison by a double blind trial - E. Ngwane. - 1980 (Arch Dis Childhood 1980;55:171-174) |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45468 |
Study title: Dean JCS et al. Long term health and neurodevelopment in children exposed to antiepileptic drugs before birth. J Med Genet 2002;39:251-9. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45469 |
Study title: Depacon administration, safety and efficacy in a hospital setting - Short DW. and al. - 1999 ( Epilepsia 1999 - 40 (suppl 7) : 226 (abstract 3.248) ) - Publication in Ergenyl Vial Expert report on the clinical documentation - HUFNAGEL 14/11/2006 - |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45471 |
Study title: Divalproex sodium treatment in late adolescent and young adult acute mania - Papatheodorou G. Kutcher SP. - 1993 (Psychopharmacol Bull 1993, 29 : 213-19) - Publication in expert report on the clinical documentation - Giudicelli A. -05/2002 - |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45472 |
Study title: Do seizures in children cause intellectual deterioration ? - Ellenberg JH et al. - N Engl J. Med 1986; 314:1085-88. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45473 |
Study title: An Open Label, Non-Comparative Protocol for the Emergency Use of Voriconazole in Patients with Life-threatening, Invasive Mycoses who are failing on currently available antifungal Agents |
Active substance: VORICONAZOLE |
Study summary document link (including results): A1501050 EMA Pediatrics Web Synopsis.pdf |
View full study record |
Document reference: 48057 |
Study title: An Open Label, Non-comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections |
Active substance: VORICONAZOLE |
Study summary document link (including results): 150-309 and 150-604 EMA Pediatrics Web Synopsis.pdf |
View full study record |
Document reference: 48050 |
Study title: An open-label, long-term evaluation of Sertraline in children and adolescents with obsessive compulsive disorder or depression. |
Active substance: SERTRALINE |
Study summary document link (including results): |
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Document reference: 42129 |
Study title: Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7.Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42256 |
Study title: Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7.Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42288 |
Study title: Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7.Driscoll WS, Nowjack-Raymer R, Heifetz SB, Li SH, Selwitz RH. Evaluation of the comparative effectiveness of fluoride mouthrinsing, fluoride tablets, and both procedures in combination: interim findings after five years. J Public Health Dent. 1990 Winter;50(1):13-7. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
View full study record |
Document reference: 42320 |
Study title: Fluoride retention in sound and demineralized enamel in vivo after treatment with a fluoride varnish (Duraphat). |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
View full study record |
Document reference: 42390 |
Study title: Fluoride retention in sound and demineralized enamel in vivo after treatment with a fluoride varnish (Duraphat). |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42503 |
Study title: Fluoride varnish versus acidulated phosphate fluoride for schoolchildren in Manipal. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42426 |
Study title: Fluoride varnish versus acidulated phosphate fluoride for schoolchildren in Manipal. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42539 |
Study title: Fluoride varnishes (Duraphat): a meta-analysis. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42367 |
Study title: Fluoride varnishes (Duraphat): a meta-analysis. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42480 |
Study title: Fluoride varnishes in caries prevention. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42533 |
Study title: To evaluate the effect of two years of treatment with three different dose regimens of Norditropin® SimpleXx® on height in children with intrauterine growth retardation ages 3 to <8 years at start of treatment; a randomized, parallel, multinational trial |
Active substance: Somatropin |
Study summary document link (including results): GHLiquid-1424_Norditropin.pdf |
View full study record |
Document reference: 41775 |
Study title: Suoranta H, Standertskjöld-Nordenstam CG, Lähde S. The value of simethicone in abdominal preparation. Radiology. 1979 Nov;133(2):307-8Suoranta H, Standertskjöld-Nordenstam CG, Lähde S. The value of simethicone in abdominal preparation. Radiology. 1979 Nov;133(2):307-8 |
Active substance: SIMETICONE |
Study summary document link (including results): |
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Document reference: 42222 |
Study title: Voepel-Lewis TD et al. Evaluation of simethicone for the treatment of postoperative abdominal discomfort in infants. J Clin Anesth. March 1, 1998, 91-4Voepel-Lewis TD et al. Evaluation of simethicone for the treatment of postoperative abdominal discomfort in infants. J Clin Anesth. March 1, 1998, 91-4 |
Active substance: SIMETICONE |
Study summary document link (including results): |
View full study record |
Document reference: 42190 |
Study title: An Open Label, Non-comparative, Multicentre, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections |
Active substance: VORICONAZOLE |
Study summary document link (including results): 150-309 and 150-604 EMA Pediatrics Web Synopsis.pdf |
View full study record |
Document reference: 48049 |
Study title: An Open Multicentre Study of the Efficacy, Safety and Toleration of UK-109,496 (Voriconazole) in the Treatment of Chronic Invasive Aspergillosis and Candidiasis |
Active substance: VORICONAZOLE |
Study summary document link (including results): A150-303 EMA Pediatrics Web Synopsis.pdf |
View full study record |
Document reference: 48052 |
Study title: An Open, Multicentre, Dose Escalating Study of the Efficacy, Safety and Toleration of UK-109,496 (Voriconazole) in the Treatment of Acute Invasive Aspergillosis |
Active substance: VORICONAZOLE |
Study summary document link (including results): 150-304 EMA Pediatrics Web Synopsis.pdf |
View full study record |
Document reference: 48048 |
Study title: Bumbalo, T.S. (1960) Xylometazoline HCl, a new nasal medication for paediatric use (an evaluation). West. Med. 1, 9 |
Active substance: XYLOMETAZOLINE |
Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - Bumbalo_1960.xls |
View full study record |
Document reference: 45638 |
Study title: De Sa, JV. (1960) Clinical evaluation of a new topical vaso-constrictor in rhinology. Indian Pract. 12, 725-728 |
Active substance: XYLOMETAZOLINE |
Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - de Sa_1960.xls |
View full study record |
Document reference: 45639 |
Study title: Effect of antiepileptic drugs on psychomotor development in offspring of epileptic mothers. - Ohtsuka Y et al. - Epilepsia 1999;40 (Suppl 2):296 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45474 |
Study title: Effect size of lithium, divalproex sodium, and carbamazepine in children and adolescents with bipolar disorder - Kowatsch RA. and al. - 2000 ( J Am Acad Child Adolesc Psychiatry 2000, 39 (6) : 713-720 - Publication in expert report on the clinical documentation - Grunze H. - 04/2003 - |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45475 |
Study title: Fluoride varnishes in caries prevention]. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
View full study record |
Document reference: 42416 |
Study title: Fluoride varnishes in caries prevention]. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
View full study record |
Document reference: 42529 |
Study title: Fluoride varnishes--a review. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
View full study record |
Document reference: 42349 |
Study title: Fluoride varnishes--a review. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
View full study record |
Document reference: 42462 |
Study title: Fluorine gradients in outermost surface enamel after various forms of topical application of fluorides in vivo. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
View full study record |
Document reference: 42395 |
Study title: Fluorine gradients in outermost surface enamel after various forms of topical application of fluorides in vivo. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42508 |
Study title: A Randomized, Double-Blind, 12-Week Trial Evaluating the Safety of the Fluticasone Propionate/Sameterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Sympotmatic Pediatric Subjects (4-11 Years) With Asthma. Report No. RM2002/00268/00; |
Active substance: SALMETEROL |
Study summary document link (including results): |
View full study record |
Document reference: 35596 |
Study title: A Stratified, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial Evaluating the Safety and Efficacy of the Fluticasone Propionate/Salmeterol Diskus Combination Product 100/50mcg Once Daily Versus Fluticasone Propionate Diskus 100mcg Once Daily and Placebo in Symptomatic Pediatric Subjects (4-11 Years) With Asthma. Report No. RM2001/00010/07 |
Active substance: SALMETEROL |
Study summary document link (including results): |
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Document reference: 35595 |
Study title: De Oliveira Netto N.V. & Diegues A. (1976): Estudo aberto n¿o comparativo do PR-S/109*, no tratamento das broncopatias obstrutivas por secreç¿es. Folha Med. 72(4): 393-7. De Oliveira Netto N.V. & Diegues A. (1976): Estudo aberto n¿o comparativo do PR-S/109*, no tratamento das broncopatias obstrutivas por secreç¿es. Folha Med. 72(4): 393-7. |
Active substance: SOBREROL |
Study summary document link (including results): |
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Document reference: 42231 |
Study title: Etude contrôlée d¿un nouveau composé à action mucolytique. Acta Therapeutica 7: 243-60. Romano C., Gargani G.F., Cotellessa M. and Rossi C. (1977): Valutazione comparativa del sobrerolo nel trattamento delle broncopneumopatie croniche dell¿età pediatrica. Terzo Congresso Europeo sulle malattie del torace: 52-61. Trombetti E. & Mancino V. (1971) Etude contrôlée d¿un nouveau composé à action mucolytique. Acta Therapeutica 7: 243-60. Romano C., Gargani G.F., Cotellessa M. and Rossi C. (1977): Valutazione comparativa del sobrerolo nel trattamento delle broncopneumopatie croniche dell¿età pediatrica. Terzo Congresso Europeo sulle malattie del torace: 52-61. Trombetti E. & Mancino V. (1971) |
Active substance: SOBREROL |
Study summary document link (including results): |
View full study record |
Document reference: 42227 |
Study title: Paediatric dentistry discussion paper and case report. Management of small carious lesions in primary teeth: caries removal versus fluoride application and periodic 'observation' until exfoliation. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
View full study record |
Document reference: 42360 |
Study title: Paediatric dentistry discussion paper and case report. Management of small carious lesions in primary teeth: caries removal versus fluoride application and periodic 'observation' until exfoliation. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
View full study record |
Document reference: 42473 |
Study title: Effects of valproate in 100 children with special reference to weight. - Egger J et al. - Br Med J 1981;283:577-81. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45476 |
Study title: Ellenberg JH et al. Do seizures in children cause intellectual deterioration ? N Engl J. Med 1986; 314:1085-88. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45477 |
Study title: Epilepsy in general paediatric practice - Muddiman M.J. and al. - 1983 (Br. J. Clin. Pract., 1983 symposium, suppl. 27, 99-104) |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45478 |
Study title: Ethosuximide, sodium valproate or lamotrigine for absence seizures in children and adolescents. EB Posner. Cochrane database Syst Rev. 2005;(4):CD003032 in CES EXPCRC-CES733-EN-E01. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45479 |
Study title: Expertise clinique. Etude d'activité et de tolérance (Phase II) - Sorel L. - 12/07/1979 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45480 |
Study title: Febrile seizures. In: epileptic syndromes in infancy, childhood and adolescence. - Camfield PR et al. - J Roger et al editors. John Libbey and Co Ltd publishers. 3rd edition. 2002; chapter 11: 145-152. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45481 |
Study title: Fried S et al. Malformation rates in chidren of women with untreated epilepsy. A meta-analysis. Drug Safety 2004;27(3):197-202. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45482 |
Study title: Guerrini R. et al. Antiepileptic drug-induced worsening of seizures in children. Epilepsia 1998; 39 (suppl. 3): S2-S10 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45484 |
Study title: Haigh D et al. The treatment of childhood epilepsy with sodium valproate. Develop Med Child Neurol 1975;17:743-8 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45485 |
Study title: Herranz JL et al. Side effects of valproate in monotherapy controlled by plasma levels: a study in 88 pediatric patients. Epilepsia 1982;23:203-14. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45486 |
Study title: High doses of sodium valproate in refractory childhood epilepsies - F. Viani, 1989, Boll Lega + Epil 66/67 (308-309 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45487 |
Study title: Importancia de latoma de muestra en la monitorizacion de niveles plasmáticos de ác. Valproic em doentes pediatricos - Quintana, Vergana B. Farmac. Clinica vol 7 n10 (1990) |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45488 |
Study title: Initiation and tolerance of intravenous valproate in children (abstract), Thomas AB, Wheless JW, Willmore LJ, Galan JA, Curtis VL, Martinez H. Epilepsia 1993; 34 (suppl. 6): 81-2 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45489 |
Study title: Intravenous valproate : experience in neurosurgery - Proceedings of the fourth International Symposium of Sodium Valproate and Epilepsy - Price D.J and Chadwick D. - 1989 ( International Congress and Symposium Series n° 152 ) ( London : Royal Society of Medecines Services, 1989 - 197-203 ) Publication 5 in Ergenyl Via Expert report on the clinical documentation - Hufnagel A. - 14/11/2006 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45490 |
Study title: Evaluation of the efficacy and tolerance of roxithromycin 5-8 mg/kg/day taken B.I.D. and clarithromycin 11-21 mg/kg/day taken B.I.D. in a 5 to 10 days treatment of lower respiratory tract infections in children. |
Active substance: ROXYTHROMYCIN |
Study summary document link (including results): FF9496564.pdf |
View full study record |
Document reference: 45229 |
Study title: An open-labeled study evaluating the safety and efficacy of growth hormone therapy in short children with chronic renal insufficiency |
Active substance: Somatropin |
Study summary document link (including results): 90-127 and 90-128 EMA Pediatrics Web Synopsis.pdf |
View full study record |
Document reference: 41711 |
Study title: An open-labeled study evaluating the safety and efficacy of growth hormone therapy in short children with chronic renal insufficiency |
Active substance: Somatropin |
Study summary document link (including results): 90-127 and 90-128 EMA Pediatrics Web Synopsis.pdf |
View full study record |
Document reference: 41712 |
Study title: An open-labeled study evaluating the safety and efficacy of growth hormone therapy in short prepubertal and pubertal children on dialysis |
Active substance: Somatropin |
Study summary document link (including results): 91-005 and 91-006 EMA Pediatrics Web Synopsis.pdf |
View full study record |
Document reference: 41708 |
Study title: An open-labeled study evaluating the safety and efficacy of growth hormone therapy in short prepubertal children with chronic renal insufficiency |
Active substance: Somatropin |
Study summary document link (including results): TRN 92-8123-003 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 41749 |
Study title: AN OPEN-LABELLED MULTI-CENTRE STUDY EVALUATING THE SAFETY AND EFFICACY OF GROWTH HORMONE THERAPY IN SHORT PUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFICIENCY |
Active substance: Somatropin |
Study summary document link (including results): 95-8123-016 EMA Pediatrics Web Synopsis.pdf |
View full study record |
Document reference: 41669 |
Study title: AN OPEN-LABELLED STUDY EVALUATING THE EFFICACY AND SAFETY OF GROWTH HORMONE IN SHORT PREPUBERTAL CHILDREN WITH CHRONIC RENAL INSUFFUCUENCY (HUNGARY) |
Active substance: Somatropin |
Study summary document link (including results): 91-094 EMA Pediatrics Web Synopsis.pdf |
View full study record |
Document reference: 41694 |
Study title: An Open, Multi-Centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin Simplexx™ in Children with GH Deficiency |
Active substance: Somatropin |
Study summary document link (including results): GHLiquid-1315_Norditropin.pdf |
View full study record |
Document reference: 41815 |
Study title: The use of Solcoseryl Eye-Gel in the treatment of certain diseases of cornea and conjunctiva |
Active substance: SALICYLIC ACID AND UREA |
Study summary document link (including results): |
View full study record |
Document reference: 35582 |
Study title: An observational study to assess the health related quality of life impact of treating poorly controlled asthmatic children with SeretideÔ 50/100mcg |
Active substance: SALMETEROL |
Study summary document link (including results): |
View full study record |
Document reference: 35600 |
Study title: Growth hormone treatment of prematures with chronic lung disease (CLD) receiving dexamethasone treatment. A double blind, placebo controlled trial, evaluating whether treatment with growth hormone will reduce the negative effects of Dexamethasone treatmen |
Active substance: Somatropin |
Study summary document link (including results): |
View full study record |
Document reference: 41799 |
Study title: Hochban, W et al. Nasal decongestion with imidazoline derivatives: acoustic rhinometry measurements. Eur J Clin Pharmacol 1999; 55(1):7-12 |
Active substance: XYLOMETAZOLINE |
Study summary document link (including results): |
View full study record |
Document reference: 45634 |
Study title: McNeill M.D. (1960) A new topical vasoconstrictor, (xylometazoline) n paediatrics. Gen. Pract. 24(4):342-344 |
Active substance: XYLOMETAZOLINE |
Study summary document link (including results): 2011-EMA spreadsheet - Otrivin - McNeill_1960.xls |
View full study record |
Document reference: 45648 |
Study title: Michel O et al. The value of Ems Mineral Salts in the treatment of rhinosinusitis in children: Prospective study on the efficacy of mineral salts versus xylometazoline in the topical nasal treatment of children. Int J Pediatr Otorhinolaryngol 2005; 69(10):1359-1365 |
Active substance: XYLOMETAZOLINE |
Study summary document link (including results): |
View full study record |
Document reference: 45632 |
Study title: Intravenous valproic acid administration in status epilepticus - Czapinski P. and al. - 1998 ( Neurol. Neurochir. Pol. 1998 ; 32 : 11-22 ) Publication 3 in Ergenyl Via Expert report on the clinical documentation - Hufnagel A. - 14/11/2006 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45491 |
Study title: An open, multi-centre trial evaluating acceptance of the new liquid growth hormone formulation - Norditropin® SimpleXx® in children with GH deficiency |
Active substance: Somatropin |
Study summary document link (including results): GHLiquid-1515_Norditropin.pdf |
View full study record |
Document reference: 41816 |
Study title: An open, randomised multicentre crossover trial evaluating the acceptance of the new Liquid Norditropin® formulation versus the freeze-dried powder Norditropin® in treatment naïve Turner Syndrome children. |
Active substance: Somatropin |
Study summary document link (including results): GHLiquid-3338_Norditropin.pdf |
View full study record |
Document reference: 41818 |
Study title: An open, randomised, mulicenter, 2-period crossover trial, evaluating the acceptance and compliance of Norditropin® SimpleXxTM/NordiPenTM versus Norditropin®/Nordiject® |
Active substance: Somatropin |
Study summary document link (including results): |
View full study record |
Document reference: 41812 |
Study title: INVESTIGATION OF THE CARDIOVASCULAR EFFECTS OF BIOSYNTHETIC GROWTH HORMONE (GENOTROPIN) IN CHILDREN WITH SHORT STATURE |
Active substance: Somatropin |
Study summary document link (including results): |
View full study record |
Document reference: 41725 |
Study title: A single-centre, randomised, double-blind, placebo controlled, parallel group study to evaluate the efficacy of salmeterol (50mcg BD via the diskhaler) in children aged 6-16 years who have asthma that is difficult to control. Report No. GRP/95/024; |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Study SLPX01- SMS30029-Salmeterol Xinafoate-Serevent Rotadisks.xls |
View full study record |
Document reference: 42062 |
Study title: Kiszely; 1982 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45470 |
Study title: Lee WL et al. Management of epilepsy in children. In: the treatment of epilepsy. S. Shorvon ed. Blackwell publ. 2004; chapter 15: 190-200. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45492 |
Study title: Long term health and neurodevelopment in children exposed to antiepileptic drugs before birth. - Dean JCS et al. - J Med Genet 2002;39:251-9. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45493 |
Study title: Major malformations in infants exposed to antiepileptic drugs in utero with emphasis on carbamazepine and valproic acid: a nation-wide, population-based register study. - Wide K et al. - Acta Paediatr 2004;93:174-6. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45494 |
Study title: Malformation rates in chidren of women with untreated epilepsy. A meta-analysis. - Fried S et al. - Drug Safety 2004;27(3):197-202. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45495 |
Study title: Malformations withdrawal manifestations and hypoglycaemia after exposure to valproate in utero. - Thisted et al. - Arch Dis Child 1993;69:288-291. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45496 |
Study title: Management of epilepsy in children. In: the treatment of epilepsy. - Lee WL et al. - S. Shorvon ed. Blackwell publ. 2004; chapter 15: 190-200. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45497 |
Study title: Maternal use of antiepileptic drugs and the risk of major congenital malformations: a joint European prospective study of human teratogenesis associated with maternal epilepsy. - Samren EB et al. - Epilepsia 1997;38(9):981-90. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45498 |
Study title: Monotherapie par le valproate de sodium dans les epilepsies de l'enfant - Dulac O. and al. - 1982 (arch. Fr. Pediatr., 1982, 39, (6), 347-352) |
Active substance: VALPROIC ACID |
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Document reference: 45499 |
Study title: Monotherapiy in children with epilepsy: a preliminary report advances in epileptology - Mc Gowan and al. - 1983 (XIVth Epilepsy International symposium, 1983, 283-290) |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45500 |
Study title: Monotherapy with sodium valproate in childhood epilepsy - Jeavons P.M. and al. - 1980 (Symp. Reckitt-labaz: Birmingham, 8-9th, nov. 1979 - Int. Congr. & Simp. Series, 1980, 1, (30), 53-58) |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45501 |
Study title: Normal intelligence in children with prenatal exposure to carbamazepine. - Gaily E et al. - Neurology 2004;62:28-32. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45502 |
Study title: Ohtsuka Y et al. Effect of antiepileptic drugs on psychomotor development in offspring of epileptic mothers. Epilepsia 1999;40 (Suppl 2):296 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
View full study record |
Document reference: 45503 |
Study title: Open-study of the efficacy and safety of LA 40220 SRF in the treatment of partial seizure/generalized epilepsy |
Active substance: VALPROIC ACID |
Study summary document link (including results): Sodium Valproate-Study 2.pdf |
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Document reference: 47745 |
Study title: Overview: Syndromes of Infancy and Early childhood - Epilepsy: A coprehensive Textbook - 1997, p, 2263 - 65 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45504 |
Study title: post-marketing surveillance (once daily in the evening), report 2004 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45505 |
Study title: A Phase III, Multicenter, Open-Label Study Evaluating the Effect of Multiple Exposure to Sevoflurane for the Maintenance of Anesthesia in Pediatric ASA Class I, II, and III Inpatients |
Active substance: SEVOFLURANE |
Study summary document link (including results): Sevoflurane-P92-098.pdf |
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Document reference: 42158 |
Study title: A Phase III, Multicenter, Open-Label, Randomized, Comparative Study Evaluating the Effect of Sevoflurane Versus Halothane in the Induction and Maintenance of Anesthesia in Pediatric ASA Class I and II Outpatients |
Active substance: SEVOFLURANE |
Study summary document link (including results): Sevoflurane-P92-090.pdf |
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Document reference: 42156 |
Study title: A Phase III, Multicenter, Open-Label, Randomized, Comparative Study Evaluating the Effect of Sevoflurane Versus Halothane in the Induction and Maintenance of Anesthesia in Pediatric ASA Class I and II Inpatients |
Active substance: SEVOFLURANE |
Study summary document link (including results): Sevoflurane-P92-091.pdf |
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Document reference: 42157 |
Study title: A Phase III, Single Center, Open-Label Study Evaluating the Production of Compound A When Sevoflurane is Administered for the Induction and Maintenance of Anesthesia in Pediatric ASA Class I, II, and III Patients |
Active substance: SEVOFLURANE |
Study summary document link (including results): |
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Document reference: 42162 |
Study title: Effect of a fluoride varnish on primary dentition. Dental research in Finland 1982. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42392 |
Study title: Effect of a fluoride varnish on primary dentition. Dental research in Finland 1982. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42505 |
Study title: Effect of Fluor-Protector varnish on the inhibition of the carious process in milk teeth |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42437 |
Study title: Gervais AA. Pediatric health: Colic. Can Pharm J. September 1, 1996, 27-8Gervais AA. Pediatric health: Colic. Can Pharm J. September 1, 1996, 27-8 |
Active substance: SIMETICONE |
Study summary document link (including results): |
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Document reference: 42191 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Spascupreel (ampoules) [AWB-AT] |
Active substance: Spascupreel - Ampullen/ Spascupreel S |
Study summary document link (including results): |
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Document reference: 40205 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Spascupreel (injection solution/suppositories/tablets) [AWB-073] |
Active substance: Spascupreel - Tabletten/ Spascupreel - Zäpfchen/ Spascupreel S |
Study summary document link (including results): |
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Document reference: 40207 |
Study title: Prospective, multicenter, observational study to document therapeutic data in the use of Spascupreel (tablets) in the treatment of spasms of the gastrointestinal tract [AWB-136] |
Active substance: Spascupreel - Tabletten/ Spascupreel S |
Study summary document link (including results): |
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Document reference: 40210 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to the treatment of spasms by children aged up to 11 years old with Spascupreel S tablets [AWB-134] |
Active substance: Spascupreel - Tabletten/ Spascupreel S |
Study summary document link (including results): |
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Document reference: 40209 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Spascupreel (tablets) [AWB-034] |
Active substance: Spascupreel - Tabletten/ Spascupreel S |
Study summary document link (including results): |
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Document reference: 40208 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to the treatment of spasms by children aged up to 11 years old with Spascupreel S (suppositories) [AWB-135] |
Active substance: Spascupreel - Zäpfchen/ Spascupreel S |
Study summary document link (including results): |
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Document reference: 40212 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Spascupreel S (suppositories) [AWB-AT] |
Active substance: Spascupreel - Zäpfchen/ Spascupreel S |
Study summary document link (including results): |
View full study record |
Document reference: 40211 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Spigelon (drops) [AWB-AT] |
Active substance: Spigelon |
Study summary document link (including results): |
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Document reference: 40243 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Spigelon (tablets) [AWB-AT] |
Active substance: Spigelon |
Study summary document link (including results): |
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Document reference: 40244 |
Study title: Orlandi O., Verzellino A., Bruna S. and Perino A. (1973): Osservazioni cliniche su di un nuovo broncodisostruente di sintesi: il sobrerolo. Gazzetta Medica Italiana 132: 18-23.Orlandi O., Verzellino A., Bruna S. and Perino A. (1973): Osservazioni cliniche su di un nuovo broncodisostruente di sintesi: il sobrerolo. Gazzetta Medica Italiana 132: 18-23. |
Active substance: SOBREROL |
Study summary document link (including results): |
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Document reference: 42230 |
Study title: Pellegrini U. Double-blind evaluation of the bronchial cleansing effect of cyclidrol in paediatrics. Report non pubblicato. Milvio C.,Pellegrini U. Double-blind evaluation of the bronchial cleansing effect of cyclidrol in paediatrics. Report non pubblicato. Milvio C., |
Active substance: SOBREROL |
Study summary document link (including results): EUdraCT_reduced_datafields_for_Interim_publication - Mucodox (Sobrerol).pdf |
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Document reference: 42225 |
Study title: Pubication in well established dossier of hydroxychloroquine: Advanced drug therapy for Juvenile rheumatoid arthritis - Rosenberg AM -1989 |
Active substance: SODIUM AUROTHIOMALATE |
Study summary document link (including results): |
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Document reference: 42232 |
Study title: BSS Alcon Studies: Clinical Evaluation of the Safety of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus for Use During Cataract Extraction in Pediatric Patients. |
Active substance: SODIUM CHLORIDE |
Study summary document link (including results): |
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Document reference: 42233 |
Study title: A repeat dose open-label, seafety evaluation of a live yeast cell derivative wound healing ointment in out-patients with minor cuts, scrapes, abrasions, and burns |
Active substance: YEAST CELL EXTRACT AND SHARK LIVER OIL |
Study summary document link (including results): |
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Document reference: 39447 |
Study title: Coursaget P, Fritzell B, Blondeau C, Saliou P and Diop-Mar I. Simultaneous injection of plasma-derived or recombinant hepatitis B vaccines with yellow fever and killed polio vaccines. Vaccine 1995; 13: 109-111 |
Active substance: Yellow Fever Vaccine (Live) |
Study summary document link (including results): |
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Document reference: 41386 |
Study title: Lhuillier M, Mazzariol MJ, Zadi S, Le Cam N, Bentejac MC, Adamowicz L, Marie NL and Fritzell B. Study of combined vaccination against yellow fever and measles in infants from six to nine months. J Biol Stand 1989; 17: 9-15. |
Active substance: Yellow Fever Vaccine (Live) |
Study summary document link (including results): |
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Document reference: 41387 |
Study title: Mouchon D, Pignon D, Vicens R, Tu-Ha-Tnanh, Tekaia F, Teulières L and Garrigue G. Etude de la vaccination combinée rougeole-fièvre jaune chez l’enfant africain âgé de 6 à 10 mois. [Study of the combined vaccination against measles and yellow fever in African infants aged 6-10 months]. Bull Soc Path Ex 1990; 83: 537-551 |
Active substance: Yellow Fever Vaccine (Live) |
Study summary document link (including results): |
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Document reference: 41388 |
Study title: post-marketing surveillance (once daily in the evening), report 2006 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45506 |
Study title: post-marketing surveillance, report 2001 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45507 |
Study title: Effect of Fluor-Protector varnish on the inhibition of the carious process in milk teeth |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42550 |
Study title: Effect of fortnightly rinsing with a 0.2% NaF solution and a fluoride varnish with 5% NaF in dental caries prevention: comparative study in students of the northern region of Sao Paulo city, Brazil, 1992-1993 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42402 |
Study title: Effect of fortnightly rinsing with a 0.2% NaF solution and a fluoride varnish with 5% NaF in dental caries prevention: comparative study in students of the northern region of Sao Paulo city, Brazil, 1992-1993 |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42515 |
Study title: Effect of schoolbased fluoride varnish programmeson approximal caries in adolescents from different caries risk areas. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42425 |
Study title: Effect of schoolbased fluoride varnish programmeson approximal caries in adolescents from different caries risk areas. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42538 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Sabal-Homaccord (ampoules) [AWB-AT] |
Active substance: Sabal-Homaccord - Ampullen |
Study summary document link (including results): |
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Document reference: 40161 |
Study title: A double-blind randomised, placebo controlled, crossover study to evaluate the duration of protection from exercise induced bronchospasm of inhaled salmeterol xinafoate 50μg (from a Diskhaler) after a single dose and after treatment with 50μg twice daily, for 28 days in children and adolescents with asthma. |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Salmeterol-Xinafoate-SLGB4003-ICHE3.pdf |
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Document reference: 42046 |
Study title: Congenital nonspherocytic haemolytic jaundice due to pyruvate kinase deficiency: splenic destruction of chromium-51 –labeled erythrocytes.Haematologica. 1973;58(11):803-9. |
Active substance: SODIUM CHROMATE |
Study summary document link (including results): 2011-09 GE response Sodium Chromate List of published articles.doc |
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Document reference: 48290 |
Study title: Erythrocyte survival in the newborn infant, as measured by chromium 51 and its relation to the postnatal serum bilirubin level.J Pediatr. 1961 Aug;59:194-9. |
Active substance: SODIUM CHROMATE |
Study summary document link (including results): Vest MF 1961.pdf |
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Document reference: 48289 |
Study title: Impiego di una nuova molecola di sintesi, il sobrerolo, nelle affezioni dell¿albero respiratorio in pediatria. Il Lattante 42: 309-13. Impiego di una nuova molecola di sintesi, il sobrerolo, nelle affezioni dell¿albero respiratorio in pediatria. Il Lattante 42: 309-13. |
Active substance: SOBREROL |
Study summary document link (including results): |
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Document reference: 42228 |
Study title: Post-treatment effect of fluoride varnishes in children with a high prevalence of dental caries in a community with fluoridated water. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42534 |
Study title: Predictors of recurrent febrile convulsions: a metaanalytic review. - Berg AT et al. - J Pediatr 1990; 116: 329-337. |
Active substance: VALPROIC ACID |
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Document reference: 45508 |
Study title: Prevention and management of febrile convulsions. - Baumann RJ. - Paedriatr Drugs 2001; 3: 585-592. |
Active substance: VALPROIC ACID |
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Document reference: 45509 |
Study title: Prognosis in children with febrile convulsions. - Nelson KB et al. - Pediatrics 1978; 61: 720-727. |
Active substance: VALPROIC ACID |
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Document reference: 45510 |
Study title: Prospective study of development of infants born to mothers with epilepsy. - James FH et al. - J Neurol Neurosurg Psychiatry 2002;72:135. |
Active substance: VALPROIC ACID |
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Document reference: 45511 |
Study title: Specific cognitive dysfunction in children with epileptic mothers. - Gaily et al. - Dev Med Child Neurol 1990;32-403-414. |
Active substance: VALPROIC ACID |
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Document reference: 45512 |
Study title: Status Epilepticus in children. Experience with intravenous valproate. Update of treatment guidelines - Campistol and al. - 1999 ( Rev. Neurol.1999 - 29 : 359-65 ) Publication 1 in Ergenyl Via Expert report on the clinical documentation - Hufnagel A. - 14/11/2006 |
Active substance: VALPROIC ACID |
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Document reference: 45513 |
Study title: STUDY OF TOLERANCE OF THE SODIUM DIVALPROATE (DEPAKOTE) AT TEENAGERS SUFFERING FROM BIPOLAR IN PHASE MANIAC, MIXED DISORDER OR HYPOMANIAQUE |
Active substance: VALPROIC ACID |
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Document reference: 45514 |
Study title: Teratogenic effects of antiepileptic drugs: use of an international database on malformations and drug exposure (MADRE). - Arpino C et al. - Epilepsia 2000;41(11):1436-43. |
Active substance: VALPROIC ACID |
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Document reference: 45515 |
Study title: The epilepsies – febrile convulsions. - Trescher WH et al. - In : WG Bradley et al. Neurology in clinical practice. 4th edition. Elsevier edition 2004; vol II, chapter 73: 1963-64. |
Active substance: VALPROIC ACID |
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Document reference: 45516 |
Study title: The longer term outcome of children born to mothers with epilepsy. - Adab et al. - J Neurol Neurosurg Psychiatry 2004;75:1575-83. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45517 |
Study title: The safety of intravenous valproate study. - Mattson - 1993 - In the report MAA0461 - |
Active substance: VALPROIC ACID |
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Document reference: 45518 |
Study title: The treatment of childhood epilepsy with sodium valproate. - Haigh D et al. - Develop Med Child Neurol 1975;17:743-8 |
Active substance: VALPROIC ACID |
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Document reference: 45519 |
Study title: Thisted et al. Malformations withdrawal manifestations and hypoglycaemia after exposure to valproate in utero. Arch Dis Child 1993;69:288-291. |
Active substance: VALPROIC ACID |
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Document reference: 45520 |
Study title: Treatment of children with simple febrile convulsions: the AAP practice parameter. - Baumann RJ. et al. - Pediatr Neurol 2000; 23:11-17. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45521 |
Study title: Treatment of febrile seizures. In: epilepsy: a comprehensive textbook. - Camfield PR et al. - J Engel and TA Pedley editors. Lippincott-Raven publishers. Philadelphia (USA) 1997; chapter 118: 1305-1309 |
Active substance: VALPROIC ACID |
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Document reference: 45522 |
Study title: Treatment of generalized epilepsies of childhood and adolescence with sodium valproate. - Jeavons PM et al. - Develop Med Child Neurol 1977;19:9-25. |
Active substance: VALPROIC ACID |
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Document reference: 45523 |
Study title: Evaluacion clinica de la administracion de Saccharomyces boulardii "vitales" en el tratamiento de la diarrea aguda en ninos. Informe preliminar.; La Semana Medica 1985 ; 167 (9) : 254-262. |
Active substance: Saccharomyces boulardii |
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Document reference: 40182 |
Study title: Evaluacion terapeutica de Saccharomyces boulardii en ninos con diarrea aguda.; Tribuna Medica 1989; 56 (2) : 111-115. |
Active substance: Saccharomyces boulardii |
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Document reference: 40181 |
Study title: Trescher WH et al. The epilepsies – febrile convulsions. In : WG Bradley et al. Neurology in clinical practice. 4th edition. Elsevier edition 2004; vol II, chapter 73: 1963-64. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45524 |
Study title: Controlled study to evaluate the efficacy and safety of the treatment with liquid Norditropin which will be started randomly at the ages of 2 to 5, in children diagnosed of intrauterine growth retardation |
Active substance: Somatropin |
Study summary document link (including results): |
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Document reference: 41780 |
Study title: A Phase III, Single Center, Open-Label, Randomized, Comparative Study Evaluating the Effect of Sevoflurane Versus Halothane on Hepatic Metabolism in the Induction and Maintenance of Anesthesia in Pediatric Inpatients |
Active substance: SEVOFLURANE |
Study summary document link (including results): Sevoflurane-P92-084.pdf |
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Document reference: 42155 |
Study title: An open-label, multi-center, phase IV study to evaluate the efficacy and safety profiles of sevoflurane in pediatric subjects of different ages undergoing inpatient surgery with general anesthesia |
Active substance: SEVOFLURANE |
Study summary document link (including results): Sevoflurane-CHIN-05-001.pdf |
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Document reference: 42152 |
Study title: Evaluation of the Clinical and Consumption Differences between Sevoflurane Innovative Drug and Sevoflurane Similar Drug - Pilot Study |
Active substance: SEVOFLURANE |
Study summary document link (including results): |
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Document reference: 42154 |
Study title: Kark W, Krebs-Richter H, Hotz J. Improving the effect of orthograde colonic lavage with golytely solution by adding dimethicone. Z Gastroenterol. 1995 Jan;33(1):20-3Kark W, Krebs-Richter H, Hotz J. Improving the effect of orthograde colonic lavage with golytely solution by adding dimethicone. Z Gastroenterol. 1995 Jan;33(1):20-3 |
Active substance: SIMETICONE |
Study summary document link (including results): |
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Document reference: 42211 |
Study title: Clinical study of salmeterol xinafoate (SN408) dry powder. Bioequivalency study between salmeterol xinafoate aerosol in children with bronchial asthma by single dose crossover method. Report No. JJA/93/011; |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Study SMS40086-SD102-Salmeterol Xinafoate-Serevent Rotadisks.xls |
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Document reference: 42043 |
Study title: Clinical study of Salmeterol xinafoate dry powder. Bioequivalency study between Salmeterol xinafoate aerosol in children with bronchial asthma by a single dose, cross-over method. Report No. JJA/93/011 |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): |
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Document reference: 42059 |
Study title: Effect of four week regular Salmeterol treatment on cardiovascular autonomic balance in asthmatic children. |
Active substance: SALMETEROL (XINAFOATE) |
Study summary document link (including results): Study SMS40094-Salmeterol Xinafoate-Serevent Rotadisks.xls |
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Document reference: 42060 |
Study title: Verapamil plus antiarrhythmic drugs reduce atrial fibrillation recurrences after an electrical cardioversion (VEPARAF Study).De Simone A, De Pasquale M, De Matteis C, Canciello M, Manzo M, Sabino L, Alfano F, Di− Mauro M, Campana A, De−Fabrizio G, Vitale DF, Turco P, Stabile−G. European heart journal, Aug 2003, vol. 24, no. 15, p. 1425−9, Verapamil plus antiarrhythmic drugs reduce atrial fibrillation recurrences after an electrical cardioversion (VEPARAF Study).De Simone A, De Pasquale M, De Matteis C, Canciello M, Manzo M, Sabino L, Alfano F, Di− Mauro M, Campana A, De−Fabrizio G, Vitale DF, Turco P, Stabile−G. European heart journal, Aug 2003, vol. 24, no. 15, p. 1425−9, |
Active substance: VERAPAMIL |
Study summary document link (including results): |
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Document reference: 45537 |
Study title: Use of injectable valproic acid in status epilepticus - Giroud M. and al. - 1993 ( Drug Invest 1993 ; 5 : 154-9 ) Publication 2 in Ergenyl Via Expert report on the clinical documentation - Hufnagel A. - 14/11/2006 |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45525 |
Study title: Verity CM et al. Risk of epilepsy after febrile: a national cohort study. Br. Med J 1991; 303:1373-76. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45526 |
Study title: Vit. B6 and valproic acid in treatment of infantile spasms, Masatoshi Ho., pag. 331-336, 1991 - Pediatric Neurol. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45527 |
Study title: Wallace SJ. A comparative review of the adverse effects of anticonvulsants in children with epilepsy. Drug safety 1996; 15(6): 378-393. |
Active substance: VALPROIC ACID |
Study summary document link (including results): |
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Document reference: 45528 |
Study title: Analyse des résultats obtenus avec le DEPAMIDE chez des enfants atteints d'instabilité psychomotrice (hyperkinésie) - F. MAIRLOT - 11/01/77 |
Active substance: VALPROMIDE |
Study summary document link (including results): |
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Document reference: 45529 |
Study title: Etude comparative du DEPAMIDE et du DEPAKINE dans le traitement de l'épilepsie associée à des troubles caractériels - M. SMIDTS - 16/01/78 |
Active substance: VALPROMIDE |
Study summary document link (including results): |
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Document reference: 45530 |
Study title: Recherche chez les enfants des propriétés anti-convulsiantes et neurotropes, contrôle de la tolérance et de l'innocuité - R. MISES - 19.06.67 |
Active substance: VALPROMIDE |
Study summary document link (including results): |
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Document reference: 45531 |
Study title: A 4-week, double-blind, randomized, multi-center study followed by 12 months open-label treatment to evaluate the dose-response and safety of valsartan in pediatric hypertensive patients 1-5 years of ageDOI: 10.1161/HYPERTENSIONAHA.108.111054 Journal reference: Hypertension - Journal of the American Heart Association 2008;52:1-7. |
Active substance: VALSARTAN |
Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2307_2-.xls |
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Document reference: 47270 |
Study title: A 4-week, double-blind, randomized, multi-center study followed by 12 months open-label treatment to evaluate the dose-response and safety of valsartan in pediatric hypertensive patients 1-5 years of age |
Active substance: VALSARTAN |
Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2307_2-.xls |
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Document reference: 48169 |
Study title: A Double-Blind, Randomized, Multicenter Study followed by 12 Months Open-label Treatment to Evaluate the Dose-response and Safety of Valsartan in Pediatric Hypertensive PatientsDOI: 1111/j.1751-7176.2011.00432.x Journal Clinical Hypertension: 2011;13:357-365 |
Active substance: VALSARTAN |
Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2302_2.xls |
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Document reference: 47268 |
Study title: A Double-Blind, Randomized, Multicenter Study followed by 12 Months Open-label Treatment to Evaluate the Dose-response and Safety of Valsartan in Pediatric Hypertensive Patients |
Active substance: VALSARTAN |
Study summary document link (including results): EMA spreadsheet_Diovan_CVAL489A2302_2.xls |
View full study record |
Document reference: 48167 |
Study title: Impact Sibutramine Therapy in Children with Hypothalamic Obesity or Obesity with Aggravating Syndromes |
Active substance: SIBUTRAMINE |
Study summary document link (including results): sibutramine-danielsson.xls |
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Document reference: 48136 |
Study title: A 7 -Day, Open-Label, Multicenter, Pharmacokinetic study (Part 1) followed by a 7-Day, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study (Part 2) of IV Sildenafil in the treatment of neonates with persistent pulmonary hypertension of the newborn (PPHN) or hypoxic respiratory failure and at risk for PPHN. |
Active substance: sildenafil |
Study summary document link (including results): A1481157 PhRMA Web Synopsis.pdf |
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Document reference: 41606 |
Study title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study of intravenous Sidenafil in the treatment of children, aged 0 to 17 with pulmonary hypertension. |
Active substance: sildenafil |
Study summary document link (including results): A1481134 EMA Pediatrics Web Synopsis.pdf |
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Document reference: 41605 |
Study title: Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42351 |
Study title: Effectiveness of silver diamine fluoride and sodium fluoride varnish in arresting dentin caries in Chinese pre-school children |
Active substance: SODIUM FLUORIDE |
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Document reference: 42464 |
Study title: Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125.Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42262 |
Study title: Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125.Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42294 |
Study title: Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125.Heifetz SB, Horowitz HS, Meyers RJ, Li SH. Evaluation of the comparative effectiveness of fluoride mouth rinsing, fluoride tablets, and both procedures in combination: interim findings after zwo years. Pediatric Dentistry 1987; 9: 121-125. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42326 |
Study title: Verapamil versus flunarizina nella terapia preventiva dell'emicrania. (Verapamil versus flunarizine in the preventive therapy of hemicrania).Lastilla M, Achille P, Savarese MA, Frascella G. La Clinica terapeutica, 31 Mar 1990, vol. 132, no. 6, p. 401−4, Verapamil versus flunarizina nella terapia preventiva dell'emicrania. (Verapamil versus flunarizine in the preventive therapy of hemicrania).Lastilla M, Achille P, Savarese MA, Frascella G. La Clinica terapeutica, 31 Mar 1990, vol. 132, no. 6, p. 401−4, |
Active substance: VERAPAMIL |
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Document reference: 45559 |
Study title: Zur antiarrhythmischen Wirksamkeit von Disopyramid bei ventrikulärer Extrasystolie und Vorhofflimmern. (Antiarrhythmic effect of disopyramide in ventricular extrasystole and auricular fibrillation).Breithardt G, Haerten K, Seipel L. Zeitschrift für Kardiologie, Aug 1976, vol. 65, no. 8, p. 713−23,Zur antiarrhythmischen Wirksamkeit von Disopyramid bei ventrikulärer Extrasystolie und Vorhofflimmern. (Antiarrhythmic effect of disopyramide in ventricular extrasystole and auricular fibrillation).Breithardt G, Haerten K, Seipel L. Zeitschrift für Kardiologie, Aug 1976, vol. 65, no. 8, p. 713−23, |
Active substance: VERAPAMIL |
Study summary document link (including results): |
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Document reference: 45565 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Veratrum-Homaccord (drops) [AWB-AT] |
Active substance: Veratrum-Homaccord |
Study summary document link (including results): |
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Document reference: 40300 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Vertigoheel (tablets) in children aged up to 11 years old [AWB-089] |
Active substance: Vertigoheel |
Study summary document link (including results): |
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Document reference: 40303 |
Study title: Prospective, multicenter, observational study to document therapeutic data in the use of Vertigoheel (tablets) in the treatment vertigo [AWB-114] |
Active substance: Vertigoheel |
Study summary document link (including results): |
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Document reference: 40304 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Vertigoheel (tablets) [AWB-AT] |
Active substance: Vertigoheel |
Study summary document link (including results): |
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Document reference: 40302 |
Study title: Open, multicentric, post marketing surveillance study of GlaxoSmithKline Biologicals’ Vi polysaccharide typhoid vaccine (TYPHERIXÔ) injected in healthy children and adults according to the Indian prescribing information. |
Active substance: Vi polysaccharide of Salmonella typhi |
Study summary document link (including results): |
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Document reference: 47496 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to the treatment of agitation (with and without fever) by children aged up to 11 years with Viburcol (suppositories) [AWB-097] |
Active substance: Viburcol |
Study summary document link (including results): |
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Document reference: 40306 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Viburcol (suppositories) [AWB-AT] |
Active substance: Viburcol |
Study summary document link (including results): |
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Document reference: 40305 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to the treatment of acute feverish infects by children aged up to 11 years with Viburcol N (suppositories) [AWB-118] |
Active substance: Viburcol N |
Study summary document link (including results): |
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Document reference: 40307 |
Study title: The use of medicated soap for Pityriasis Versicolor.Thisted et al. Malformations withdrawal manifestations and hypoglycaemia after exposure to valproate in utero. Arch Dis Child 1993;69:288-291. |
Active substance: URINARY CONCREMENT SOLVENTS |
Study summary document link (including results): |
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Document reference: 39153 |
Study title: Evaluation of a fluoride-containing varnish in children with low caries incidence. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42377 |
Study title: Evaluation of a fluoride-containing varnish in children with low caries incidence. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42490 |
Study title: Evaluation of a routine for prevention and treatment of fissure caries in permanent first molars. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42401 |
Study title: Evaluation of a routine for prevention and treatment of fissure caries in permanent first molars. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42514 |
Study title: Evaluation of non-invasive treatment applied to occlusal surfaces. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42358 |
Study title: Evaluation of non-invasive treatment applied to occlusal surfaces. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42471 |
Study title: Evaluation thérapeutique de Saccharomyces boulardii chez des enfants souffrant de diarrhée aiguë.Annales de Pédiatrie 1994 ; 41 (6) : 397 - 400. |
Active substance: Saccharomyces boulardii |
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Document reference: 40163 |
Study title: Value of bone scan in the McCune-Albright syndrome. Report of a case. Edeburn GF, Mortensson W. Acta Radiol Diagn (Stockh). 1986 Nov-Dec;27(6):719-21. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
Study summary document link (including results): |
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Document reference: 43887 |
Study title: Abnormal whole-body technetium-99m MDP scintigraphy indicating cortical hyperostosis following long-term administration of prostataglandin E-1 in an infant with cyanotic congenital heart disease.Edeling CJ, Frederiksen PB. Clin Nucl Med. 1987 Jan;12(1):74. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44276 |
Study title: Edeling CJ. 99mTc-methylene diphosphonate uptake in a primary Wilms' tumor. Eur J Nucl Med. 1983;8(1):30. No abstract available. Edeling CJ. 99mTc-methylene diphosphonate uptake in a primary Wilms' tumor. Eur J Nucl Med. 1983;8(1):30. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44055 |
Study title: Edeling CJ. Observations on the sequential use of Tc-99m phosphonate and Ga-67 imaging in untreated primary and secondary malignant tumors of the head and neck. Clin Nucl Med. 1983 Mar;8(3):107-111. Edeling CJ. Observations on the sequential use of Tc-99m phosphonate and Ga-67 imaging in untreated primary and secondary malignant tumors of the head and neck. Clin Nucl Med. 1983 Mar;8(3):107-111. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 44044 |
Study title: Egashira K, Ohno M, Uchino A, Hayashi K, Nakayama C, Nakata H. [Bone scintigraphy of decompression sickness] Nippon Igaku Hoshasen Gakkai Zasshi. 1988 Jun 25;48(6):749-58. Japanese. No abstract available. Egashira K, Ohno M, Uchino A, Hayashi K, Nakayama C, Nakata H. [Bone scintigraphy of decompression sickness] Nippon Igaku Hoshasen Gakkai Zasshi. 1988 Jun 25;48(6):749-58. Japanese. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43814 |
Study title: Sports-related groin pain: evaluation with MR imaging. Ekberg O, Sjöberg S, Westlin N. Eur Radiol. 1996;6(1):52-5. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43571 |
Study title: Wu H, Dimitrakopoulou-Strauss A, Heichel TO, Lehner B, Bernd L, Ewerbeck V, et al.. Quantitative evaluation of skeletal tumours with dynamic FDG PET: SUV in comparison to Patlak analysis. [wu-2001]Eur J Nucl Med. 2001 Jun;28(6):704-10. Wu H 2001 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48714 |
Study title: A STUDY OF THE EFFICACY AND SAFETY OF GENOTONORM (REGISTERED) IN SHORT STATURE PATIENTS WITH A HISTORY OF INTRAUTERINE GROWTH RETARDATION. A TWO-YEAR, OPEN RANDOMIZED STUDY. GENETICMOLECULAR AND BIOCHEMICALHORMONONAL EVALUATION |
Active substance: Somatropin |
Study summary document link (including results): 307-MET-0021-003 PhRMA Web Synopsis .pdf |
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Document reference: 41643 |
Study title: A study to evaluate the effectivity and safety of introducing biosynthetic human growth hormone (Norditropin PenSet) for treatment of children with growth hormone deficiency in Bulgaria |
Active substance: Somatropin |
Study summary document link (including results): GHD-ROV-5-BU_Norditropin.pdf |
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Document reference: 41760 |
Study title: Myocardial localization of technetium-99m MDP in an infant. Fleming JC, Pysher TJ, Leonard JC. Clin Nucl Med. 1986 May;11(5):369-70. No abstract available. |
Active substance: TECHNETIUM (99mTc) MEDRONIC ACID |
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Document reference: 43910 |
Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
View full study record |
Document reference: 43181 |
Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
View full study record |
Document reference: 43191 |
Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
View full study record |
Document reference: 43201 |
Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
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Document reference: 43215 |
Study title: Walter MA, Melzer RA, Schindler C, Müller-Brand J, Tyndall A, Nitzsche EU.. Epub 2005 Mar 4. The value of [18F]FDG-PET in the diagnosis of large-vessel vasculitis and the assessment of activity and extent of disease. [walter-2005]Eur J Nucl Med Mol Imaging. 2005 Jun;32(6):674-81. Walter MA 2005 |
Active substance: Steripet |
Study summary document link (including results): 2011-09 GE response Template List of published articles.doc |
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Document reference: 48709 |
Study title: A 2-year report on caries prevention by fluoride varnishes in a community with fluoridated water. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42417 |
Study title: A 2-year report on caries prevention by fluoride varnishes in a community with fluoridated water. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42419 |
Study title: A 2-year report on caries prevention by fluoride varnishes in a community with fluoridated water. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42530 |
Study title: A 2-year report on caries prevention by fluoride varnishes in a community with fluoridated water. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42532 |
Study title: A 24-month study comparing sealant and fluoride varnish in caries reduction on different permanent first molar surfaces. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42346 |
Study title: A 24-month study comparing sealant and fluoride varnish in caries reduction on different permanent first molar surfaces. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42459 |
Study title: A clinical estimation of the fluoride used during application of a fluoride varnish. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42408 |
Study title: A clinical estimation of the fluoride used during application of a fluoride varnish. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42521 |
Study title: A cluster randomised controlled trial to evaluate the effectiveness of fluoride varnish as a public health measure to reduce caries in children. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42363 |
Study title: A cluster randomised controlled trial to evaluate the effectiveness of fluoride varnish as a public health measure to reduce caries in children. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42476 |
Study title: A combined application of ART-fluoride varnish for immigrant junior field-workers: 12-months follow-up field trial in rural Anatolia. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42356 |
Study title: Relationship between caries and fluoride uptake by enamel from two fluoride varnishes in a community with fluoridated water. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42531 |
Study title: Results of a 32-month fluoride varnish study in Sherbrooke and Lac-Megantic, Canada. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42353 |
Study title: Results of a 32-month fluoride varnish study in Sherbrooke and Lac-Megantic, Canada. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42466 |
Study title: Results of a promising open trial to prevent baby bottle tooth decay: a fluoride varnish study. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42439 |
Study title: Results of a promising open trial to prevent baby bottle tooth decay: a fluoride varnish study. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42552 |
Study title: Clinical Expert Report - Rovamycin syrup - J. Paupe - May 22nd, 1980Clinical Expert Report - Rovamycin syrup - J. Paupe - May 22nd, 1980 |
Active substance: SPIRAMYCIN |
Study summary document link (including results): |
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Document reference: 42576 |
Study title: Clinical view of toxoplasmosis in children - personal observations - Czarnecka-Rudnik D, Stanek-Bazylko F. - Pol Merkuriusz Lek 1997 May; 2(11):237-30Clinical view of toxoplasmosis in children - personal observations - Czarnecka-Rudnik D, Stanek-Bazylko F. - Pol Merkuriusz Lek 1997 May; 2(11):237-30 |
Active substance: SPIRAMYCIN |
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Document reference: 42586 |
Study title: Compared Biodisponibility in human - Rovamycin Syrup 0,375 MUI - J. Gaillot - August 26, 1976Compared Biodisponibility in human - Rovamycin Syrup 0,375 MUI - J. Gaillot - August 26, 1976 |
Active substance: SPIRAMYCIN |
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Document reference: 42577 |
Study title: Etude Clinique Nationale de la Rovamycin Sirop - J.R. Paupe - 1980 - RPR FileEtude Clinique Nationale de la Rovamycin Sirop - J.R. Paupe - 1980 - RPR File |
Active substance: SPIRAMYCIN |
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Document reference: 42578 |
Study title: Expert Clinical Assessment - Rovamycine 1.5 M.I.U. - Freeze-dried preparation and solution for slow intravenous injection - F. Vachon - March 1985Expert Clinical Assessment - Rovamycine 1.5 M.I.U. - Freeze-dried preparation and solution for slow intravenous injection - F. Vachon - March 1985 |
Active substance: SPIRAMYCIN |
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Document reference: 42579 |
Study title: Intérêt de la Rovamycine Sirop en pédiatrie - H. Batellier, PS Jouk - 1982 (Tome XIII N° 1) |
Active substance: SPIRAMYCIN |
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Document reference: 42580 |
Study title: QT interval prolongation and cardiac arrest during antibiotic therapy with spiramycin in a newbron child - Stramba-Badiale et al in American Heart Jounal 1993, vol 126, number 3, part I |
Active substance: SPIRAMYCIN |
Study summary document link (including results): |
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Document reference: 42588 |
Study title: A combined application of ART-fluoride varnish for immigrant junior field-workers: 12-months follow-up field trial in rural Anatolia. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42469 |
Study title: A review on fluoride varnishes: an alternative topical fluoride treatment. |
Active substance: SODIUM FLUORIDE |
Study summary document link (including results): |
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Document reference: 42352 |
Study title: A review on fluoride varnishes: an alternative topical fluoride treatment. |
Active substance: SODIUM FLUORIDE |
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Document reference: 42465 |
Study title: Evaluation de l'efficacité et de la tolérance d'une suspension de secnidazole dans le traitement de la dysentrie ambienne aiguë non compliquée chez l'enfant - Dr F. Djebbar - No date |
Active substance: SECNIDAZOLE |
Study summary document link (including results): Secnidazole STUDY SZ8002.xls |
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Document reference: 42114 |
Study title: Evaluation of the efficacy and safety of a single dose of secnidazole suspension (30 mg/kg) in the treatment of giardiasis in children - Dr Cimerman, Dr Katz, Dr Zingano - 1988 (registration dossier) |
Active substance: SECNIDAZOLE |
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Document reference: 42115 |
Study title: Evaluation of the efficacy and tolerance of a suspension of secnidazole in the treatment of acute uncomplicated amoebic dysentery in children (Study n° SZ 80002) - Dr J.M. Cardo-Salles, Dr Tall, Bobo Di Oulasso, Dr Josseran, Prof R. Lenoble - 1987 to 1988 (registration dossier) |
Active substance: SECNIDAZOLE |
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Document reference: 42116 |
Study title: Study of the relative bioavailability of the 10 % suspension in relation to the tablet each containing 500 mg (reference formulation) in the young healthy subject - A. Le Liboux, G. Montay, A. Frydman and J. Gaillot - 1987 (registration dossier) |
Active substance: SECNIDAZOLE |
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Document reference: 42119 |
Study title: Prospective multicentric observational study/long term use |
Active substance: Sedacur forte; 1 coated tablet contains: 75 mg valerian root dry extract (5-6:1) (extractive agent: ethanol 70% (v/v)), 23 mg hop strobile dry extract (4-8:1) (extractive agent: methanol 40% (v/v)), 45 mg balm leaves dry extract (4-6:1) (extractive agent: purified water) Sedacur forte Beruhigungsdragees; 1 coated tablet contains: 75 mg valerian root dry extract (5-6:1) (extractive agent: et... |
Study summary document link (including results): |
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Document reference: 39756 |
Study title: Prospective observational study |
Active substance: Sedacur forte; 1 coated tablet contains: 75 mg valerian root dry extract (5-6:1) (extractive agent: ethanol 70% (v/v)), 23 mg hop strobile dry extract (4-8:1) (extractive agent: methanol 40% (v/v)), 45 mg balm leaves dry extract (4-6:1) (extractive agent: purified water) Sedacur forte Beruhigungsdragees; 1 coated tablet contains: 75 mg valerian root dry extract (5-6:1) (extractive agent: et... |
Study summary document link (including results): |
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Document reference: 39757 |
Study title: Prospective, multicenter, observational study to document therapeutic data relating to treatment with Selenium-Homaccord (drops) [AWB-AT] |
Active substance: Selenium-Homaccord/Selenium-Homaccord - Tropfen |
Study summary document link (including results): |
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Document reference: 40190 |
Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
View full study record |
Document reference: 43225 |
Study title: Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522.Lackner H, Urban C, Benesch M, Raith J, Moser A, Sovinz P et al. Multimodal treatment of children with unresectable or recurrent desmoid tumors: An 11-year longitudinal observational study. Journal of Pediatric Hematology/Oncology 26(8)()(pp 518-522), 2004 Date of Publication: Aug 2004 2004;(8):518-522. |
Active substance: TAMOXIFEN |
Study summary document link (including results): |
View full study record |
Document reference: 43235 |