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

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

- 11/14/17 - 1 form, 10 itemgroups, 71 items, 2 languages

Itemgroups: 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)

CDASH Medical History

- 6/20/18 - 1 form, 4 itemgroups, 13 items, 3 languages

Itemgroups: General information, High Blood Pressure, Appendectomy, Other

modified from http://www.cdisc.org

German Center for Diabetes Research (DZD) - Core Data Set - Base set

- 7/15/24 - 2 forms, 8 itemgroups, 147 items, 2 languages

Itemgroups: IG.1, IG.2, IG.3, IG.4, IG.5, IG.6, IG.7, Fragebogen

The German Center for Diabetes Research (DZD) has created a core data set for research on diabetes. It is published with permission by the DZD. The complete metadata and SOP are registered at DOI 10.5281/zenodo.7360000 For more information on the work of the DZD see: www.dzd-ev.de/en or contact: studien@dzd-ev.de German Center for Diabetes Research (DZD) Head Office at Helmholtz Zentrum München Ingolstädter Landstr. 1 85764 Neuherberg, Germany The German and English version of the Baecke Questionnaire in this core data set is based on the original paper by Baecke et al (https://doi.org/10.1093/ajcn/36.5.936), redistributed by ten Velde et al. (https://doi.org/10.1371/journal.pone.0256448), and the German translation and modification by Wagner & Singer (2003). The questionnaire was selectively modified by the German Diabetes Center (DDZ). Changes in this version 4 (15.07.2024) compared to version 3 (26.02.2024) include the addition of the parameters defined in the core data set of the German Centers for Health Research (DZG) (ID of MDM entry: 45851), the addition of laterality-specific blindness and an update of the terminology coding. The coding of the DZG parameters is currently under revision and not included in this current version. The coding of those DZG parameters that were already included in the DZD CDS will be provisionally retained.

Optional Set

3 itemgroups 46 items

CLL History BO17072 NCT00090051 - History of Chronic lymphocytic leukemia NCT0090051

- 9/27/21 - 1 form, 5 itemgroups, 13 items, 1 language

Itemgroups: Vital signs and physical measurements, Sitting measurements, "B" symptoms, General physical examination, ECG

An open-label, multicenter, randomized, comparative, phase III study to evaluate the efficacy and safety of rituximab plus fludarabine and cyclophosphamide (FCR) versus fludarabine and cyclophosphamide alone (FC) in previously treated patients with CD20 positive B-cell chronic lymphocytic leukemia (CLL). FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients NCT00090051 Roche BO17072

Lifestyle Questionnaire GSK study Chronic Coronary Heart Disease NCT00799903

- 9/20/21 - 1 form, 11 itemgroups, 73 items, 1 language

Itemgroups: Diet, Alcoholic drinks, Weekly activity, Physical activity, Health-related limitations in physical activity, Symptoms limiting physical activity, Sleep, Stress assessment, Lifestyle comparison before and after heart problem, Lifestyle since first heart problem, Socio-economic

Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Lifestyle Questionnaire.

Efficacy and Tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg) ID 101999 - Headache Impact Test (HIT-6) Score, IHS Headache Classification, Migraine History, Previous Treatment for Migraine

- 9/20/21 - 1 form, 5 itemgroups, 33 items, 1 language

Itemgroups: Administrative Data, Head Impact Test (HIT-6) Score, IHS Headache Classification1, Migraine History, Previous Treatment for Migraine

This ODM-file contains the form to document the Head impact test (HIT-6) Score, the IHS Headache classification, the migraine history and the previous migraine treatment. To be assessed at screening. Study ID: 101999 Clinical Study ID: 101999 Study Title: A randomized, double-blind, parallel group, placebo-controlled, single-attack evaluation of the efficacy and tolerability of TREXIMA™ (sumatriptan 85mg/naproxen sodium 500mg)* tablets vs placebo when administered during the mild pain phase of a migraine 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran Study Indication: Migraine Disorders

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

- 9/20/21 - 1 form, 5 itemgroups, 39 items, 1 language

Itemgroups: 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

Iodine 131 B1 Antibody for B-Cell Lymphomas NCT00950755 - History of Lymphoma

- 9/20/21 - 1 form, 5 itemgroups, 21 items, 1 language

Itemgroups: Administrative Data, Cell Type, Grade, Extranodal Involvement at Enrollment, CD20 Reactivity

Study ID: 104505 Clinical Study ID: BEX104505 Study Title: Phase II Study of Iodine 131 Anti B1 Antibody for 1st or 2nd Relapsed Indolent B-Cell Lymphomas or B-Cell Lymphomas That Have Transformed to a More Aggressive Histology Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00950755 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers NCT00289718 - Long-Term Follow Up (Year 12, Visit 1) - Informed Consent; Demographics; General medical history/ Physical examination; Laboratory Tests; Blood sample conclusion; Vaccine Administration; Unsolicited Adverse Events; Solicited Adverse Events - Local and General Symptoms

- 9/20/21 - 1 form, 12 itemgroups, 101 items, 1 language

Itemgroups: Administration, Demographics, General Medical History / Physical Examination, Medical Condition, Laboratory Tests, HCG Urine Pregnancy Test, Blood Sample Conclusion, Vaccine Administration, Vaccine Administration, Unsolicited Adverse Events, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - General Symptoms

Study ID: 100556 (Y11) Clinical Study ID: 100556 Study Title: Long-Term Persistence Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Adult Volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289718 Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Visit 1 Ponderosa CML ZKSJ0083 - Visit 1

- 9/20/21 - 1 form, 11 itemgroups, 191 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria, Informed consent, Demographics, Myeloid Leukemia, Chronic, therapy CML, Patient medical history, medical history, Blood pressure, Laboratory parameters, Treatment

Study part: Visit 1.Observational study on CML patients in any phase treated with ponatinib (Iclusig®) at any dose. Principal Investigator Prof. Dr. A. Hochhaus.

Hypersensitivity/ Anaphylaxis Evaluation Mepolizumab HES NCT00086658 - Hypersensitivity/ Anaphylaxis Evaluation

- 9/20/21 - 1 form, 1 itemgroup, 53 items, 1 language

Itemgroup: evaluation Hypersensitivity

Study part: Hypersensitivity/ Anaphylaxis Evaluation.A Phase 2 Multicenter, Double-blind, Placebo-controlled, Study to to Evaluate the Corticosteroid- sparing effects of Mepolizumab in Subjects with Hypereosinophilic Syndromes (HES) and Evaluate Efficacy and Safety of Mepolizumab in Controlling the Clinical Signs and Symptoms of subjects with HES Patient Level Data: Study Listed on ClinicalStudyDataRequest.com. Sponsor: GlaxoSmithKline. Study ID: 100185, Clinical Study ID:MHE100185.

Dose Level 1 GSK Ropinirole Restless Legs Syndrome 101468

- 9/20/21 - 1 form, 11 itemgroups, 67 items, 1 language

Itemgroups: Patient Information, Predose Checklist, RLS Rating Scale, Prior Medication, Pregnancy Test, Pre-Dose Vital Signs, Baseline Signs and Symptoms, Dosing Details, Post-Dose Vital Signs, Adverse Event, Study Protocol

Study ID: 101468/207 Clinical Study ID: SKF-101468/207 Study Title:A double-blind, randomized, placebo-controlled, parallel-group study to investigate the tolerability of a dose-escalating regimen 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 2 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication : Restless Legs Syndrome Dose Level 1 (Day 1)

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