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Table of contents
  1. 1. Clinical Trial
    1. 1.1. Eligibility Determination
    1. 1.2. Medical History
    1. 1.3. Physical Examination
    1. 1.4. Assessment Score
    1. 1.5. Apparative Diagnostics
    1. 1.6. Laboratory
    1. 1.7. Pathology/Histology
    1. 1.8. Consent
    1. 1.9. Therapy
    1. 1.10. Operative Report
    1. 1.11. Adverse Event
    1. 1.12. Follow-Up
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
  7. 7. Medical Specialty
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Bioavailability and Pharmacokinetics of Testosterone with/without Dutasteride - 106218 - Part 2 - Screening Visit - Eligibility Criteria

- 11/17/21 - 1 form, 4 itemgroups, 33 items, 1 language
Itemgroups: Administrative documentation, Eligibility Determination, Inclusion, Exclusion Criteria
Study ID: 106218 Clinical Study ID: TDC106218 Study Title: Study On Bioavailability And Pharmacokinetics Of Various Doses Of Testosterone Administered With And Without Dutasteride  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: testosterone Trade Name: Andropatch,Androderm Study Indication: Hypogonadism, Male

Effect of GSK958108 on ejaculatory latency time (ELT); NCT00861484 - Logs/Repeats

- 9/27/21 - 1 form, 12 itemgroups, 130 items, 1 language
Itemgroups: Date of visit, Assessment Date, Adverse Event; Concomitant Agent; Evaluation, Repeat, Liver, Adverse Event, Non-serious Adverse Event, Serious Adverse Event, Concomitant Agent, Laboratory Procedures, Urinalysis, Vital signs, 12 lead ECG, 12 lead ECG, Abnormality, Repeat, Pharmacokinetic aspect, Blood, Repeat
Study ID: 111155 Clinical Study ID: 111155 Study Title: A double blind, parallel group, placebo controlled study to evaluate the effect of a single oral dose of GSK958108 on ejaculatory latency time (ELT) in male patients suffering from premature ejaculation. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00861484 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK958108 , Placebo Trade Name: N/A Study Indication: Premature Ejaculation

Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636 - T3-Diaries

- 9/20/21 - 1 form, 10 itemgroups, 38 items, 1 language
Itemgroups: Administrative documentation, Date of visit; Assessment Date, Migraine Disorder, Subject Diary, Experimental drug, Migraine Disorder, Subject Diary, Experimental drug, Dosage, Concomitant Agent, Concomitant Agent, Clinic, Experimental drug, Status, Concomitant Agent, Home environment, Travel
Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636 - T2-Diaries

- 9/20/21 - 1 form, 10 itemgroups, 38 items, 1 language
Itemgroups: Administrative documentation, Date of visit; Assessment Date, Migraine Disorder, Subject Diary, Experimental drug, Migraine Disorder, Subject Diary, Experimental drug, Dosage, Concomitant Agent, Concomitant Agent, Clinic, Experimental drug, Status, Concomitant Agent, Home environment, Travel
Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/218 - Dose Level 1, Day1, Pre-dose - Prior Medication; Pregnancy Test; Alcohol Breath Test; Drug Screening (Urine); Vital Signs

- 9/20/21 - 1 form, 7 itemgroups, 31 items, 1 language
Itemgroups: Administrative, Prior Medication, Prior Medication , Pregnancy Test, Alcohol Breath Test, Drug Screening (Urine) , Vital Signs
Study ID: 101468/218 Clinical Study ID: SKF-101468/218 Study Title:A Single-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multicentre, Phase IIa Study to Determine the Pharmacokinetics and Tolerability of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636 - Subject In-Clinic Diary - Screen

- 9/20/21 - 1 form, 6 itemgroups, 25 items, 1 language
Itemgroups: Administrative documentation, Pharmaceutical Preparations, Subject Diary, Blood Pressure, Exercise, Migraine Disorders, Information, Alcohol consumption, Subject Diary, Caffeine Use, Subject Diary, Tobacco Use, Subject Diary
Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Sumatriptan and Naproxen Sodium for Acute Treatment of Migraine Attacks; NCT00792636 - T1-Diaries

- 9/20/21 - 1 form, 10 itemgroups, 38 items, 1 language
Itemgroups: Administrative documentation, Date of visit; Assessment Date, Migraine Disorder, Subject Diary, Experimental drug, Migraine Disorder, Subject Diary, Experimental drug, Dosage, Concomitant Agent, Concomitant Agent, Clinic, Experimental drug, Status, Concomitant Agent, Home environment, Travel
Study ID: 110948 Clinical Study ID: 110948 Study Title: Assessment of the effect of sumatriptan and naproxen sodium combination tablet, sumatriptan tablet, and naproxen sodium tablet treatment on blood pressure when administered intermittently for six months for the acute treatment of migraine attacks, with or without aura, in adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00792636 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: sumatriptan and naproxen sodium combination tablet Trade Name: sumatriptan tablet, naproxen sodium tablet Study Indication: Migraine Disorders

Visit 10 GIMEMA CML0408 NCT00769327 - Visit 10

- 9/20/21 - 1 form, 12 itemgroups, 122 items, 2 languages
Itemgroups: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram, Echocardiogram, Biopsie, Preservation of cellular samples, Cytogenetics, FISH (from bone marrow blood), IMATINIB, Molecular Biology (peripheral blood), FISH (peripheral blood)
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 10 Form

Visit 16 GIMEMA CML0408 NCT00769327 - Visit 16

- 9/20/21 - 1 form, 11 itemgroups, 117 items, 2 languages
Itemgroups: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram, Echocardiogram, Biopsie, Preservation of cellular samples, Cytogenetics, FISH (from bone marrow blood), Molecular Biology (peripheral blood), FISH (peripheral blood)
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 16 Form

Visit 13 GIMEMA CML0408 NCT00769327 - Visit 13

- 9/20/21 - 1 form, 5 itemgroups, 56 items, 2 languages
Itemgroups: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram, Molecular Biology (peripheral blood)
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 13 Form

Visit 5 GIMEMA CML0408 NCT00769327 - Visit 5

- 9/20/21 - 1 form, 4 itemgroups, 44 items, 2 languages
Itemgroups: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 5 Form

Visit 7 GIMEMA CML0408 NCT00769327 - Visit 7

- 9/20/21 - 1 form, 13 itemgroups, 127 items, 2 languages
Itemgroups: Physical Examination, Complete Blood Count, Biochemistry, Electrocardiogram, Echocardiogram, Biopsie, Preservation of cellular samples, Cytogenetics, NILOTINIB, FISH (from bone marrow blood), IMATINIB, Molecular Biology (peripheral blood), FISH (peripheral blood)
RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. This is the Visit 7 Form

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