Search results - Portal of Medical Data Models (MDM-Portal)

Follow-up F2 LeMLAR-Studie Lymphoma NCT01788189 - Follow-up F2

- 10/6/16 - 1 form, 2 itemgroups, 131 items, 1 language

Itemgroups: follow up, clinical examination Diagnostic Imaging Manifestation of Lymphoma

Study part: Follow-up F2 LeMLAR-Studie. Lenalidomide in conjunction with methotrexate, leucovorin, cytarabine and rituximab for the treatment of relapsed or refractory CD20-positive aggressive lymphomas: an open-label, multicenter phase I/II trial. Publication granted by Prof. Dührsen and provided by Claudia Ose, University clinic Essen, NCT01788189, Version 1.3-28.04.2013.doc.

Anamnese und klinische Untersuchung OPAL-Studie DRKS00004421 NCT01619124 ALL - Anamnese und klinische Untersuchung OPAL-Studie

- 9/20/21 - 1 form, 13 itemgroups, 72 items, 2 languages

Itemgroups: Allgemeine Angaben, Tägliche Aktivitäten, Gehen, Gelenkinspektion, Bewegungsumfang (in °) Hüftgelenk, Bewegungsumfang (in °) Kniegelenk, Bewegungsumfang (in °) Sprunggelenk, Muskelbefund Oberschenkel, Muskelbefund Unterschenkel, Therapiekomplikationen, Begleitmedikation, Spez. Intervention gegen Osteonekrosen, Bemerkungen

Osteonekrosen bei pädiatrischen Patienten mit ALL

Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

- 10/10/17 - 1 form, 18 itemgroups, 72 items, 1 language

Itemgroups: Concomitant medication, Adverse event, Patient diary, 12-lead electrocardiogram report, orthostatic blood pressure / Pulse, Pregnancy test, Physical examination, Hematology Laboratory evaluation, Hematology Laboratory evaluation, Serum Laboratory evaluation, Serum laboratory evaluation, Urinalysis, Dip stick analysis, Microscopic analysis, Overall urinalysis assessment, Study Completion Part A, Study Completion Part B, Investigator signature

Follow-up - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164 Study ID: 101468/164 Clinical Study ID: 101468/164 Study Title: An open-label, randomised, two part study to investigate the relative bioavailability of Ropinirole new and standard, marketed formulations and the effect of food on the pharmacokinetics of Ropinirole new formulation in early stage Parkinson’s disease subjects 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL

Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880 - Follow-Up Visit und Unscheduled Visit Form

- 9/20/21 - 1 form, 3 itemgroups, 34 items, 1 language

Itemgroups: Administrative Data, Vital Signs, Physical Examination

This ODM file contains a form for the documention required at the follow-up and unscheduled visits. Study ID: 103880 Clinical Study ID: ARI103880 Study Title: An open label, single dose, randomized, three period crossover study to investigate the relative bioavailability of 0.5 mg of dutasteride from soft gelatin capsules (reference) vs. soft gelatin capsules containing two investigational formulations in healthy male volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier:N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: dutasteride Trade Name: Duagen,Zytefor,Avolve,Avodart,Avidart,Zyfetor; Zytefor,Zyfetor,Duagen,Avolve,Avodart,Avidart Study Indication: Prostatic Hyperplasia

Genetic Screening For HLA-B5701 n Patients with HIV Day 1 NCT00340080 - Genetic Screening For HLA-B5701 Day 1 NCT00340080

- 6/20/17 - 1 form, 1 itemgroup, 12 items, 1 language

Itemgroup: Day 1

NCT00340080 / VIIV-CNA106030 https://clinicaltrials.gov/ct2/show/NCT00340080 A phase IV, randomised, multicentre, double-blind, study to evaluate the clinical utility of prospective genetic screening (HLA-B*5701) for susceptibility to abacavir hypersensitivity Assessment: Day 1 (Cohort Study) Medicine: abacavir, Condition: Infection, Human Immunodeficiency Virus, Phase: 4, Clinical Study ID: CNA106030, Sponsor: ViiV

Determination of starting dose and up-titration regimen for a new formulation of Ropinirole in healthy adults, 101468/201 - Physical Examination Follow- Up

- 6/21/19 - 1 form, 2 itemgroups, 5 items, 1 language

Itemgroups: Administrative Data, Physical Examination

Study ID: 101468/201 Clinical Study ID: 101468/201 Study Title: A Single Blind, Parallel Group, Up-titration, Phase 1 Study in Healthy Volunteers to Determine a Starting Dose and Select an Up-titration Regimen for a new Formulation of Ropinirole 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: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Restless Legs Syndrome The Study consists of 21 Visits(Days): Screening (at least 21 days before dosing) Week 1: including Day 1-7 Week 2: including Day 8-14 Week 3: including Day 15-19 Follow-up Visit (7-14 days after last dose) This document contains the Physical Examination Follow- Up form. It has to be filled in at follow-up.

Vital Signs- Follow- Up Pazopanib Macular Degeneration MD1103367 - Vital Signs- Follow- Up

- 9/20/21 - 1 form, 1 itemgroup, 7 items, 1 language

Itemgroup: Vital signs measurements

Study part: Vital Signs- Follow- Up. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837 - Follow-UP Serious Adverse Event Form

- 11/30/18 - 1 form, 10 itemgroups, 61 items, 1 language

Itemgroups: Randomisation, Serious Adverse Event Entry, Seriousness, Relevant Concomitant/Treatment Medication, Relevant Medical Conditions/Risk Factors, Relevant Diagnosis Results, Rechallenge, Investigational Product, General narrative comments, Non Clinical

Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630 - Follow-Up Part 1 - Physical Examination, Pulmonary Function Test

- 4/10/18 - 1 form, 5 itemgroups, 48 items, 1 language

Itemgroups: Administrative data, Vital signs, Pedal Oedema, Physical examination, Pulmonary function tests / FEV 1

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Follow-Up Part 1: Physical Examination, Vital Signs and Pedal Oedema as well as Pulmonary Function Test.

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Unscheduled Vital Signs Form

- 11/19/18 - 1 form, 2 itemgroups, 23 items, 1 language

Itemgroups: Administrative data, Vital Signs

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 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

12 Lead ECG- Follow-up Pazopanib Macular Degeneration MD1103367 - 12 Lead ECG- Follow-up

- 6/20/18 - 1 form, 1 itemgroup, 8 items, 1 language

Itemgroup: 12 Lead ECG; Follow- up

Study part: 12 Lead ECG- Follow-up. A phase 1 single-masked, randomized (with respect to placebo), placebo-controlled, parallel-group, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of repeat oral doses of GW786034 in elderly healthy volunteers. Trade Name: Votrient. Clinical Study ID: MD1103367.

The Effect of Albiglutide on Cardiac Repolarisation Compared with Placebo 107085 - Liver Biopsy Diagnosis and Liver Architecture

- 11/20/18 - 1 form, 4 itemgroups, 63 items, 1 language

Itemgroups: Administrative data, Liver Biopsy, A. Final Diagnosis, B. Liver Architecture

Study ID: 107085 Clinical Study ID: GLP107085 Study Title: A Randomized, Double-blind, Parallel, Nested Crossover Study to Investigate the Effect of Albiglutide on Cardiac Repolarization (corrected QT Interval) Compared With Placebo in Healthy Male and Female Subjects: A Thorough ECG Study Employing Placebo, Albiglutide, and a Positive Control (Moxifloxacin) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01406262 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

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