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Pre-Screening Log RICH study NCT02669589

- 08.07.16 - 1 Formular, 3 Itemgruppen, 9 Datenelemente, 1 Sprache

Itemgruppen: Patient Information, Inclusion Criteria, Reason for Exclusion

NCT02669589 EudraCT-Nr. 2014-004854-33 REGIONAL CITRATE VERSUS SYSTEMIC HEPARIN ANTICOAGULATION FOR CONTINUOUS RENAL REPLACEMENT THERAPY IN CRITICALLY ILL PATIENTS WITH ACUTE KIDNEY INJURY Study Chair: Alexander Zarbock, MD University Hospital Muenster

GSK Study ID 104864-201 - Screening

- 24.04.18 - 1 Formular, 26 Itemgruppen, 84 Datenelemente, 1 Sprache

Itemgruppen: Identification Numbers, Demography, Vital Signs, 12-Lead Electrocardiogram, Echocardiogram or Multiple Gated Acquisition Scanning (MUGA), If Yes for the obtained Ejection Fraction, Chest X-Ray, History of Myelodysplastic Syndrome / Acute Myelogenous Leukemia, Previous Chemotherapy for MDS or AML, If Yes to Previous Chemotherapy for MDS or AML, Previous Biologic Therapy and/or Immunotherapy for MDS or AML, If Yes to Previous Biologic Therapy and/or Immunotherapy for MDS or AML, Toxicities Related to Previous Therapy for MDS or AML, If Yes to Toxicities Related to Previous Therapy for MDS or AML, Prior Transfusion Therapy (Including Erythropoietin), If Yes to Prior Transfusion Therapy (Including Erythropoietin), Prior Anti-Infective Therapy, If Yes to Prior Anti-Infective Therapy, Prior and Concominant Medication, If Yes to Prior and Concominant Medication, Ongoing Medical Conditions Associated with MDS or AML, If Yes to Ongoing Medical Conditions Associated with MDS or AML, Prior Malignancies, If Yes to Prior Malignancies, Significant Medical/Surgery History and Physical Examination, If Yes to Significant Medical/Surgery History and Physical Examination

Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome

EHR4CR Complete Data Inventory - EHR4CR Data Inventory

- 10.02.17 - 1 Formular, 13 Itemgruppen, 122 Datenelemente, 1 Sprache

Itemgruppen: Demographics, Diagnoses and Procedures, Vital Signs, Laboratory, Generic Laboratory Data, Medication, Adverse Events, Medical History, Clinical Findings, ECG, Patient Reported Outcome, Substance Use, Study Participation Status

Compilation of Feasibility, Patient Identification & Recruitment and Clinical Trial Execution data inventories. https://www.ncbi.nlm.nih.gov/pubmed/24410735 https://www.ncbi.nlm.nih.gov/pubmed/25991199 https://www.ncbi.nlm.nih.gov/pubmed/27875988

Clinical Study, Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS), Study ID: 101468/249, NCT00363857 - Abnormal findings at the Screening Visit

- 23.02.18 - 1 Formular, 3 Itemgruppen, 7 Datenelemente, 1 Sprache

Itemgruppen: Administration, Electrocardiogram (12 lead), Laboratory evaluation

Study ID: 101468/249 Clinical Study ID: 101468/249 Study Title: A 12-Week, Double-Blind, Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363857 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: N/A 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; Restless Legs Syndrome (RLS)

DELCODE: DZNE – Longitudinal Cognitive Impairment and Dementia Study - Screening diagnosis (Screening-Diagnose)

- 23.03.20 - 1 Formular, 5 Itemgruppen, 15 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, Screening diagnosis based on prior examinations: SCD, Screening diagnosis based on preliminary examinations: MCI, Screening diagnosis based on preliminary examinations: AD, Screening diagnosis based on preliminary examinations: healthy control

DELCODE is conducted by DZNE, the German Center for Neurodegenerative Diseases within the Helmholtz Association. The following information was taken from https://www.dzne.de/en/research/studies/clinical-studies/delcode/. Background and aims: One of the important aims of research into Alzheimer's is to find ways of detecting the disease early – if at all possible, as soon as the first minor symptoms appear, or even before any symptoms at all have appeared. Such detection capabilities are the necessary basis for development of therapies that can be applied at such early stages in the disease. Recent research indicates that such therapies could be more effective than therapies initiated during the disease's later stages. Over a period of several years, the DELCODE study is studying persons in early stages of the disease, along with various risk groups. The research is aimed at the development of procedures for characterizing early stages of the disease, at improving prediction of the course of the disease and at identifying new markers for early diagnosis of Alzheimer's-related dementia. Overview: DELCODE is set up to run for an initial period of three years, and to include a total of 1,000 study participants, who will be examined on a yearly basis. The group of participants will include persons with no complaints (healthy control subjects), patients with slight memory impairment or mild dementia and first-degree relatives of patients with diagnosed Alzheimer's disease. The minimum age for participants is 60. Course of the study: The examinations in the framework of the study will include a comprehensive interview carried out by a study investigator, a detailed neuropsychological examination (testing of memory functions and other areas of cognitive performance), a blood test and a cranial MRI scan. Optionally, subject to the study participant's consent in each case, a lumbar puncture (collection of cerebrospinal fluid) will be carried out." For more information (e.g. principle investigator and study coordination), please visit the above link or https://www.dzne.de. This document contains the screening diagnosis. It has to be filled in at the baseline of the study.

ToFingo Screening V1 Study relevant assessments NCT02325440

- 03.06.16 - 1 Formular, 1 Itemgruppe, 3 Datenelemente, 1 Sprache

Itemgruppe: Study relevant assessments

Principal Investigator: Luisa Klotz Collaborator: Novartis Information provided by (Responsible Party):University Hospital Muenster -Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya (ToFingo2) Purpose A trial in patients with relapsing remitting multiple sclerosis (RRMS) Main objectives: •To evaluate changes in the reconstitution of immune surveillance over time upon switching from natalizumab to fingolimod assessed by a change in the expression of CD49d. •To evaluate changes in the migratory capacity of immune cells/peripheral blood mononuclear cells (PBMCs) upon switching from natalizumab to fingolimod in an in-vitro model of the blood-brain-barrier (BBB). •To evaluate changes in paraclinical disease activity over time upon switching from natalizumab to fingolimod assessed by MRI (changes in Gd+, T2w lesions and DTI). •To evaluate changes in T1w / FLAIR lesions upon switching from natalizumab to fingolimod. For further Information please visit https://clinicaltrials.gov/ct2/show/NCT02325440

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

- 11.12.18 - 1 Formular, 2 Itemgruppen, 10 Datenelemente, 1 Sprache

Itemgruppen: Administrative data, Screening ECG

Study ID: 106904 Clinical Study ID: CRV106904 Study Title: A Randomized, Open-Label, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics of Carvedilol CR 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: carvedilol Trade Name: Coreg CR,Coreg Study Indication: Hypertension

Effect of Lamictal on Resting Motor Threshold Study-ID 107434 - Subject Screening Checklist

- 08.12.18 - 1 Formular, 5 Itemgruppen, 31 Datenelemente, 1 Sprache

Itemgruppen: Administrative Data, General Information, Clinical Assessments, Laboratory Tests, Conclusion

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 Checklist for the first screening of the study subject. It should be filled out at the screening visit. Every item should be checked and staff initials should be filled in next to the item. Screening Visit: 28 days prior to first dosing. Treatment Period: The day before dosing, until 48h after dosing. Follow-Up: 14-21 days after last dose

Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194) - Screening

- 20.09.21 - 1 Formular, 15 Itemgruppen, 79 Datenelemente, 1 Sprache

Itemgruppen: Administrative documentation, Restless Legs Syndrome, Screening procedure, Medical History, Restless Legs Syndrome, Diagnostic criteria, Demography, Vital Signs, Taking orthostatic vital signs, 12 lead ECG, Physical Examination, Laboratory Procedures, Evaluation, Urine dipstick test, Urine pregnancy test, Medical History, History of surgical procedures, Physical Examination, Prior Medication Usage; Concomitant Agent, Restless Legs Syndrome, Pharmaceutical Preparations, Medical History, Eligibility Determination

Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). 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: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

Ropinirole in Patients with Restless Legs Syndrome (Study ID: 101468/194) - Screening Repeat Tests

- 05.03.19 - 1 Formular, 5 Itemgruppen, 10 Datenelemente, 1 Sprache

Itemgruppen: Administrative documentation, 12 lead ECG, Physical Examination, Laboratory Procedures, Evaluation, Urine dipstick test

Study ID: 101468/194 Clinical Study ID: 101468/194 Study Title: A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). 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: ropinirole Trade Name: requip Study Indication: Restless Legs Syndrome

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

- 06.11.18 - 1 Formular, 14 Itemgruppen, 67 Datenelemente, 1 Sprache

Itemgruppen: Demography, Childbearing Potential, Physical Examination, Medical Conditions, Vital Signs, 12-lead ECG, Holter Electrocardiography, Clinical Chemistry, Hematology finding, Urinalysis, Immunogenicity Study; Blood, Urine drug screening, Ethanol measurement, Urine; Ethanol measurement, breath, HIV Seropositivity, hepatitis b serology, hepatitis C serology test

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

GSK study: Ropinirole in RLS patients 101468/243 - Screening & Repeat Tests

- 23.07.17 - 1 Formular, 15 Itemgruppen, 45 Datenelemente, 1 Sprache

Itemgruppen: Vital signs, Laboratory Evaluation, Urine Dipstick, Pregnancy dipstick, Medical Procedures, Medical Procedures, Prior and concomitant medication, prior and concomitant medication, Baseline signs and symptoms, Significant medical/surgical history and physical examination, Significant medical/surgical history and physical examination, Study Subject Participation Status, Investigator signature, Repeated Laboratory Evaluation, Repeated Urine dipstick

Module 2 - Screening & Repeat Tests 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 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

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