Resultados da pesquisa - Portal para modelos de dados médicos (portal MDM)

Grupos de itens: Administrative data, STUDY CONCLUSION: OCCURRENCE OF SERIOUS ADVERSE EVENT, STATUS OF TREATMENT BLIND, ELIMINATION CRITERIA, Withdrawal from study, INVESTIGATOR'S SIGNATURE

Study ID: 109563 Clinical Study ID: 109563 Study Title: COMPAS:A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier https://clinicaltrials.gov/ct2/show/NCT00466947 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal Polysaccharide Conjugate Vaccine (Adsorbed) Trade Name: BIO 10PN-PD-DIT; Synflorix Study Indication: Infections, Streptococcal The Study consists of three workbooks. Workbook 1: Argentina, all subjects + immuno & reacto subset Workbook 2: Panama, all subjects + immuno & reacto subset + carriage subset + additional immuno subset Workbook 3: Colombia, all subjects The protocol number for all workbooks: 109563 (10Pn-PD-DiT-028) There are ten visits in workbook 1 and 2, eight for workbook 3 (there are no visits 4 and 7): Visit 1: month 0, dose 1, 6-16 weeks of age Visit 2: month 2, dose 2, +/- 4 months of age, 49-83 days after visit 1 Visit 3: month 4, dose 3, +/- 6 months of age, 49-83 days after visit 2 Visit 4: month 5, +/- 7 months of age, 28-42 days after visit 3. Only for immuno & reacto subset + carriage subset. Visit 5: month 10-13, 12-15 months of age Visit 6: month 13-16, booster dose, 15-18 months of age, ≥ 28 days after visit 5 Visit 7: month 14-17, 16-19 months of age, 28-42 days after visit 6. Only for immuno & reacto subset, additional immuno subset + carriage subset. Visit 8: month 16-19, 18-21 months of age, ≥ 28 days after visit 6 Visit 9: month 22-25, 24-27 months of age Visit 10: Contact This document contains the study conclusion form. It's for all workbooks.

GSK Biologicals' oral HRV vaccine given with OPV in infants NCT00139334 - Study Conclusion

- 17/10/2018 - 1 Formulário, 6 Grupos de itens, 22 Elementos de dados, 1 Idioma

Grupos de itens: administrative data, Occurrence of Serious Adverse Event, Status of treatment blind, Elimination Criteria, Withdrawal from Study, Investigator's signature

Study ID: 103992 Clinical Study ID: 103992 Study Title: Evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00139334 https://clinicaltrials.gov/ct2/show/NCT00139334 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis This form is to be filled in at study conclusion (whether it is regular or preterm)

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Investigator Comment Log, Patient Discharge Notification Postcard, Last Dose of Study Drug Record, End of Study Record, Status of Randomization Code/ Investigator's Statement and Laboratory Comments

- 08/10/2018 - 1 Formulário, 9 Grupos de itens, 34 Elementos de dados, 1 Idioma

Grupos de itens: Administrative documentation, Clinical Investigators; Comment, Patient Discharge; Notifications, clinical trial drug; Dosage; Records; Last, Clinical Trials; End of protocol, Randomization; Code; Status | Clinical Investigators; Statement, Clinical Investigators; Statement, Laboratory; Comment | Evaluation; Laboratory; Unscheduled, Laboratory Results; Clinical Significance; Unexpected

Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial

Subcutaneous injections of GSK 716155 in healthy volunteers; Study ID: 105229 - Study Conclusion

- 05/10/2018 - 1 Formulário, 2 Grupos de itens, 3 Elementos de dados, 1 Idioma

Grupos de itens: Conclusion; Clinical Trials, Conclusion; Clinical Trials

Study ID: 105229 Clinical Study ID: GLP105229 Study Title: A double-blinded, randomized, placebo-controlled, staggered-parallel, escalating dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous injections of GSK 716155 in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Subcutaneous fondaparinux sodium for prevention of venous thromboembolic events; Study ID: 104619 - End of Treatment/End of Study

- 28/08/2018 - 1 Formulário, 2 Grupos de itens, 5 Elementos de dados, 1 Idioma

Grupos de itens: Therapeutic Procedure; End, Clinical Research; End

Study ID: 104619 Clinical Study ID: 63129 Study Title:A multinational, randomized, double-blind comparison of once daily subcutaneous fondaparinux sodium with placebo for the prevention of venous thromboembolic events in acutely ill medical patients (ARTEMIS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fondaparinux sodium Trade Name: Arixtra Study Indication: Thrombosis, Venous

Study End Day 28 CandiSep Anesthesiology and Intensive Care NCT02734550 - Study End Day 28

- 03/07/2018 - 1 Formulário, 1 Grupo de itens, 9 Elementos de dados, 1 Idioma

Grupo de itens: Study end

Study part: Study End Day 28. (1,3)-β-D-glucan-based diagnosis of invasive Candida infection versus culture-based diagnosis in patients with severe sepsis or septic shock and at high risk of invasive Candida infection (CandiSep). Provided by PD Dr. med. Frank Bloos, Ph.D. Clinic for Anesthesiology and Intensive care, University Clinic Jena.

Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454 - Study Conclusion, Liver Event Check, Status of Treatment Blind, Pregnancy Information, Comment Log

- 27/06/2018 - 1 Formulário, 7 Grupos de itens, 19 Elementos de dados, 1 Idioma

Grupos de itens: Administrative Data, Liver Events Assessment, Status of Treatment Blind, Pregnancy Information, Study Conclusion, Investigator Comment Log, Investigator's signature

This ODM file contains Study Conclusion, Liver Event Check, Status of Treatment Blind, Pregnancy Information, Comment Log and Signature. To be filled if study concluded or withdrawal from study for any reason. Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

Palavras-chave

Índice

Modelos de dados selecionados

Estimation of Dose Proportionality of Darapladib - 107038 - Follow-Up: Pregnancy Information

A Cross-Over Study of Alcohol Effect on the Pharmacokinetics of Carvedilol - 106904 - Logs and Repeats: 12-lead ECG Form

Delay in IELT, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK557296 in Men with Premature Ejaculation, 109059 - Study Conclusion

Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880 - Study Conclusion, Pregnancy Information, Investigator Comment Log and Investigator's Signature

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396 - Study Conclusion, Pregnancy Information, Investigator Comment Log and Investigator's Signature

Vaccination against pneumonia and otitis media, NCT00466947 - Study conclusion