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Telemedical Interventional Management in Heart Failure II (TIM-HF II) NCT01878630 - Baseline Visit

- 11/14/17 - 1 Formulär, 10 Item-grupper, 71 Dataelement, 2 Språk

Item-grupper: Physical Examination / Medical History taking, Signs and Symptoms of heart failure, Cardiovascular Diseases, Comorbidities, Current medication, Cardiovascular interventions, Implantation of a cardiac device, Hematology, ECG, Baseline visit

Short title: TIM-HF II Permission to publish granted by: Prof. Dr. Friedrich Köhler, FESC Charité - Universitätsmedizin Berlin Further study details on: https://www.clinicaltrials.gov/ct2/show/NCT01878630 Baseline Visit (BV-Form)

Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040 - Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Electrocardiogram, Laboratory Comments, Clinical Laboratory Examination, Plasma Samples and the Patient's Clinical Status - Treatment Phase Study Week 18

- 4/7/22 - 1 Formulär, 28 Item-grupper, 87 Dataelement, 1 Språk

Item-grupper: Administrative documentation, Study Subject Participation Status | Assessment Date , Study Subject Participation Status | Clinical Trial Eligibility Criteria, Physical Examination Date, Vital signs | Body Weight, Neurologic Examination; Date in time |On examination - neurological findings , Neurologic Examination | Abnormalities | Mental state, Neurologic Examination; Abnormalities | Speech and language finding, Neurologic Examination; Abnormalities | Cranial Nerves, Neurologic Examination; Abnormalities | Gait, Neurologic Examination | Abnormality | Physiologic Coordination, Neurologic Examination | Abnormality | Esthesia, Neurologic Examination | Abnormality | Muscle strength, Neurologic Examination | Abnormality | Muscle Tonus, Neurologic Examination | Abnormality | Reflex action, Electrocardiography , Laboratory; Specimen collection date , Laboratory test finding , Laboratory Results; Clinical Significance; Unexpected , Laboratory examination; Clinical | Hematology (discipline) , Laboratory examination; Clinical | Chemistry, Clinical , Urinalysis; Urine dipstick test , Serum pregnancy test (B-HCG) , plasma concentration; Antiepileptic Agents, Urine creatinine measurement, Plasma specimen, Clinical status, Clinical status; Finding

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

The relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time NCT00945503 - Day 1 - Vital Signs; 12-Lead ECG; Laboratory Results Data (Haematology, Clinical Chemistry) - Pre-Dose and 24h Post-Dose; Urinalysis - Pre-Dose and 24h Post-Dose; Randomisation Number; Investigational Product; Treatment Confirmation; PET Scan (2); fMRI Scan - Post-PET Scan; PET Scan (3); Pharmacokinetics - Blood

- 4/6/22 - 1 Formulär, 16 Item-grupper, 158 Dataelement, 1 Språk

Item-grupper: Administrative, Vital Signs, 12-Lead ECG, Laboratory Results Data (Haematology) - Pre-Dose, Laboratory Results Data (Clinical Chemistry) - Pre-Dose, Urinalysis - Pre-Dose, Randomisation Number, Investigational Product, Treatment Confirmation, PET Scan (2), fMRI Scan - Post-PET Scan, PET Scan (3), Pharmacokinetics - Blood, Laboratory Results Data (Haematology) - 24hrs Post-Dose, Laboratory Result Data (Clinical Chemistry) - 24hrs Post-Dose, Urinalysis - 24hrs Post-Dose

Study ID: 109731 Clinical Study ID: 109731 Study Title: An adaptive PET study in healthy volunteers using 11C GSK931145 to establish the relationship of Glycine Transporter1 occupancy by GSK1018921 to plasma concentrations over time Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00945503 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1018921 Study Indication: Schizophrenia

Advanced Chronic Myelogenous Leukemia (CML) NCT00123487 – On- Treatment

- 11/18/21 - 9 Formulär, 1 Item-grupp, 3 Dataelement, 1 Språk

Item-grupp: Subject details

Study documentation part: On- Treatment This is a phase III study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).Trial Number: NCT00123487. Drug: dasatinib. Phase 3

On-Treatment 1

15 Item-grupper 84 Dataelement

On-Treatment 2

13 Item-grupper 62 Dataelement

On-Treatment 4

12 Item-grupper 62 Dataelement

On-Treatment 6

12 Item-grupper 62 Dataelement

On-Treatment 7

13 Item-grupper 67 Dataelement

On-Treatment 8

13 Item-grupper 67 Dataelement

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Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - ECG Abnormalities Form

- 9/27/21 - 1 Formulär, 8 Item-grupper, 98 Dataelement, 1 Språk

Item-grupper: Administrative Data, ECG Abnormalities, Rhythm, P-Wave and QRS Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), Other Abnormalities

Study ID: 107434 Clinical Study ID: NAP107434 Study Title: A randomised, double-blind, double-dummy, placebo controlled, three-way cross-over study to investigate the effect of single oral doses of 100 mg GW273225 (4030W92) and 325 mg LAMICTAL on resting motor threshold in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Study Link: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GW273225 Trade Name: lamictal Study Indication: Bipolar Disorder This form contains information about any recorded ECG abnormalities during the study. It should be filled out everytime an ECG is performed.

12- Lead ECG, Telemetry, Holter Monitoring Pazopanib Macular Degeneration MD1103367 - 12- Lead ECG, Telemetry, Holter Monitoring

- 9/27/21 - 1 Formulär, 3 Item-grupper, 18 Dataelement, 1 Språk

Item-grupper: 12 Lead ECG, Telemetry, 24 Hour Holter Monitoring

Study part: 12- Lead ECG, Telemetry, Holter Monitoring. 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.

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

- 9/27/21 - 1 Formulär, 12 Item-grupper, 130 Dataelement, 1 Språk

Item-grupper: 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

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Repeat Local laboratory, urinalysis, vital signs, ECG and Pharmacokinetics

- 9/20/21 - 1 Formulär, 8 Item-grupper, 58 Dataelement, 1 Språk

Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram

Emotional processing in healthy male volunteers treated with GSK424887 NCT01424384 - Vital Signs and ECG - Screening

- 9/20/21 - 1 Formulär, 5 Item-grupper, 28 Dataelement, 1 Språk

Item-grupper: Patient identification, Vital signs, 12 lead ECG, Holter Electrocardiography | Summary Report, Holter Electrocardiography | Electrocardiogram abnormal | Summary Report

Study ID: 105012 Clinical Study ID: NSS105012 Study Title: Emotional processing in healthy male volunteers treated with GSK424887. A single centre, randomised, double-blind, placebo-controlled parallel group study Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01424384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK424887 Trade Name: Citalopram Study Indication: Depressive Disorder and Anxiety Disorders

Dutasteride Relative Bioavailability Soft Gelatine Capsules ID 103880 - Medical History, Physical Examination, Vital Signs and ECG (Screening)

- 9/20/21 - 1 Formulär, 5 Item-grupper, 39 Dataelement, 1 Språk

Item-grupper: Administrative Data, Medical Conditions, Physical Examination, Vital Signs, ECG

This ODM file contains the form to document the physical examination, ecg, vital signs and medical history. To be assessed at screening. 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

Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957 - Screening - 12-Lead ECG; Subject Identification; Summary Holter; Summary Holter Abnormalities

- 9/20/21 - 1 Formulär, 4 Item-grupper, 22 Dataelement, 1 Språk

Item-grupper: 12-Lead ECG, Subject Identification, Summary Holter, Summary Holter Abnormalities

Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence

GSK1034702 after Repeat Doses in Healthy Subjects; NCT00950586 - Logs and Repeats

- 9/20/21 - 1 Formulär, 16 Item-grupper, 156 Dataelement, 1 Språk

Item-grupper: 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, Vital signs, Pharmacokinetic aspect, Blood, Repeat, Pulmonary function tests, Repeat, Holter Electrocardiography, Repeat, Holter Electrocardiography, Abnormality, Repeat, Telemetry, Repeat, Telemetry, Abnormality, Repeat, 12 lead ECG, Abnormality, Repeat, 12 lead ECG

Study ID: 110792 Clinical Study ID: 110792 Study Title: A placebo-controlled, single-blind, randomised study to investigate the safety, tolerability, pharmacokinetics and drug interaction of GSK1034702 after repeat doses in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950586 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Dextromethorphan, Placebo Trade Name: N/A Study Indication: Cognitive Disorders

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