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Table of contents
  1. 1. Clinical Trial
  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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DACAPO-II Study - Verlegung vom Studienzentrum

- 1/31/22 - 6 forms, 1 itemgroup, 18 items, 1 language
Itemgroup: Zum Zeitpunkt der Verlegung
Das schwere akute Lungenversagen des Erwachsenen: Einfluss der Versorgungsqualität und individueller Patientenmerkmale auf die gesundheitsbezogene Lebensqualität bei Überlebenden (DACAPO) Surviving ARDS: the influence of quality of care and individual patient characteristics on health-related quality of life (DACAPO)

Demographische Daten

1 itemgroup 11 items

CAM-ICU

1 itemgroup 5 items

Interhospitaltransport

7 itemgroups 34 items

Externe Klinik

7 itemgroups 96 items

Studienzentrum

4 itemgroups 44 items

GSK 100262 Clinical Study Report Demography

- 5/17/17 - 1 form, 2 itemgroups, 4 items, 1 language
Itemgroups: Date of assessment, Demography
GSK 100262 Clinical Study Report Demography

CombiCaRe study - Intervention

- 11/10/23 - 12 forms, 19 itemgroups, 53 items, 1 language
Itemgroups: 5-FU, Calcium folinate & Granisetron, Surgery, Intraoperative re-evaluation, Tumor location, Surgery Details, Additional resections, Vascular resections, Additional resections, specify additional resections, Blood loss and Transfusion, transfusion type, Translational Studies, Concomitant Medication, eForm 'Concomitant Medication', Adverse Events, eForm 'Adverse Events', Protocol violations, eForm 'Protocol Violation'
CombiCaRe Protocol of a prospective, monocentric phase I/II feasibility study investigating the safety of multimodality treatment with a combination of intraoperative chemotherapy and surgical resection in locally confined or borderline resectable pancreatic cancer: the combiCaRe study. Roth S, Springfeld C, Diener MK, Tjaden C, Knebel P, Klaiber U, Michalski CW, Mieth M, Jäger D, Büchler MW, Hackert T.

Screening

15 itemgroups 94 items

POD 3

16 itemgroups 80 items

POD 7

16 itemgroups 80 items

POD 60/Discontinuation

17 itemgroups 61 items

POD 30

17 itemgroups 61 items

POD 14 / Discharge

16 itemgroups 80 items

End of study LenaMain-Study - Trial End

- 3/17/16 - 1 form, 10 itemgroups, 94 items, 1 language
Itemgroups: End of study, Survival Status, Monthly control visit with response evaluation, Parameter of multiple myeloma, Vital signs, Laboratory:Protein electrophoresis, Laboratory:Hematology, Laboratory:serum chemistry, Quality of life, Hematotoxicity CTC
A randomised comparison of daily 25 mg versus 5 mg lenalidomide as maintenance therapy after high-dose therapy and autologous stem cell transplantation in patients with multiple myeloma. Protocol-Code: RV-MM-PI-280 EudraCT-Number: 2007-003945-33 Author: Claus Schreiber Review: Gerd Felder Approval of CRF: Prof. Dr. med. G. Kobbe (LKP) Release for MDM: Prof. Gattermann, Düsseldorf (26.1.2016) Principal Investigator „LenaMain“-Studie: Prof. Roland Fenk, Düsseldorf Coordinating center for clinical trial Medical faculty of University Hospital Heinrich-Heine-University Scientific Director: Herr Dr. J. Grebe Moorenstrasse 5 40225 Düsseldorf Tel.: +49 (0) 211-81-19701 Fax: +49 (0) 211-81-19702

End of study PETAL Study NCT00554164 - End of study

- 11/23/16 - 1 form, 4 itemgroups, 25 items, 2 languages
Itemgroups: Comorbidity, Discontinuation, Adverse event, Footer module
Positronen-Emissionstomographie-gesteuerte Therapie aggressiver Non-Hodgkin-Lymphome (PETAL-Studie) Universitätsklinikum Essen (UK Essen) EudraCT-Nummer: 2006-001641-33 NCT00554164

End of Study: End of Study Post-Study Period [DS_2] NCT01117584

- 2/4/17 - 1 form, 1 itemgroup, 5 items, 1 language
Itemgroup: General Information
NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

On-Study - Waldenstroms Macroglobulinemia - On-Study Form - 2273908v3.0 - Waldenstroms Macroglobulinemia - On-Study Form

- 9/17/21 - 1 form, 5 itemgroups, 57 items, 1 language
Itemgroups: CRF Header, Waldenstrom's: Form Administration, Waldenstrom's: Disease Description, Waldenstrom's: Prior Treatment, Waldenstrom's: Relapsed Disease
Waldenstrom's Macroglobulinemia - On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D6795205-A4D9-0CD9-E034-0003BA12F5E7

On-Study - Hodgkins Lymphoma - On-Study Form - 2271441v3.0 - Hodgkins Lymphoma - On-Study Form

- 9/17/21 - 1 form, 9 itemgroups, 127 items, 1 language
Itemgroups: CRF Header, Lymphoma: Form Administration, Hodgkin's Lymphoma: Disease Description, Hodgkin's Lymphoma: Baseline Hematology/Chemistry, Lymphoma: Prior Treatment, Lymphoma: Relapsed Disease, Lymphoma: Cardiac Evaluation, Lymphoma: Pulmonary Evaluation, Lymphoma: Endocrine Evaluation
Hodgkin's Lymphoma - On-Study Form Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=D5EC9E8E-4085-0DC0-E034-0003BA12F5E7

TEST Study - ODM-Form

- 9/1/21 - 1 form, 2 itemgroups, 5 items, 1 language
Itemgroups: Lab Identification Log, Physical Examination
TEST Study

dbGaP phs000662 National Children's Study Vanguard Study Formative Research Study (NCS) - pht003558.v1.p1

- 1/24/23 - 5 forms, 1 itemgroup, 3 items, 1 language
Itemgroup: pht003558
Principal Investigator: Steven Hirschfeld, MD, PhD, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA MeSH: https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000662 The National Children's Study (NCS) is a multi-year prospective epidemiological study tasked with identifying a nationally representative sample of 100,000 children and following them from pregnancy through age 21 to study environmental impacts on growth, development, and health. Determination of NCS enrollee ancestry is important for assessing the diversity of study enrollees and for examining the effect of ancestry on various health outcomes. We estimated the genetic ancestry of a convenience sample of 641 parents enrolled at the 7 original NCS Vanguard sites by analyzing 29,972 markers on exome arrays, using the participants of the 1000 Genomes Project (1KG) super populations (e.g. European, East Asian) as reference populations, and compared this to self-reported ethnicity and race. Self-reported ethnicity and race agreed with predicted super population in 98.9% of individuals. NCS individuals identified as Asian by self-report had genetic ancestry of either South Asian or Asian groups, while those reporting as either Hispanic White or Hispanic Other had similar genetic ancestry. Of the 33 individuals who self-reported as Multiracial or Non-Hispanic Other, 11 (33%) matched the South Asian and Asian groups, while these groups were less represented in the other reported categories (27/609, 4.4%). Our data suggest that self-reported ethnicity and race categories have some limitations in accurately capturing this information for Hispanic and South Asian populations. Overall, our data indicate that despite the complexity of the U.S. population, individuals know their ancestral origins and that self-reported ethnicity and race is a reliable indicator of genetic ancestry.

pht003559.v1.p1

1 itemgroup 3 items

pht003560.v1.p1

1 itemgroup 6 items

pht003561.v1.p1

1 itemgroup 5 items

Eligibility

1 itemgroup 1 item

Study Conclusion End of Study Ropinirole NCT00632736 - Study Conclusion End of Study

- 7/30/17 - 1 form, 2 itemgroups, 6 items, 1 language
Itemgroups: STUDY CONCLUSION, Pregnancy information
Study part: Study Conclusion End of Study.An Open-Label Extension phase 3 Study with REQUIP (ropinirole) CR for Subjects from Studies 101468/165, 101468/168 and 101468/169 Patient Level Data. Study ID:101468/248, Clinical Study ID: 101468/248.

Nerventra Study Study drug dispensing and return

- 6/8/16 - 1 form, 3 itemgroups, 22 items, 1 language
Itemgroups: Demographic Information, Drug dispensed, Drug dispensing and return
Nerventra Study (Eudra CT 2007-003226-19) Study MS-LAQ-301: A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study, to evaluate the safety, tolerability and efficacy of daily oral administration of laquinimod 0.6 mg in subjects with relapsing remitting multiple sclerosis (RRMS)

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