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Sommario
  1. 1. Test clinico
  2. 2. Documentazione di routine
  3. 3. Registro / studio di coorte
  4. 4. Garanzia di qualità
  5. 5. Dati Standard
  6. 6. Risultato segnalato dal paziente
  7. 7. Specialità mediche
    1. 7.1. Anestesiologia
    1. 7.2. Dermatologia
    1. 7.3. orecchio naso gola
    1. 7.4. Geriatria
    1. 7.5. Ginecologia / Ostetricia
    1. 7.6. Medicina Interna
      1. Ematologia
      1. Malattie infettive
      1. Cardiologia / Angiologia
      1. pneumologia
      1. Gastroenterologia
      1. Nefrologia
      1. Endocrinologia / Malattie metaboliche
      1. Reumatologia
    1. 7.7. Neurologia
    1. 7.8. Oftalmologia
    1. 7.9. Cure palliative
    1. 7.10. Patologia / Forense
    1. 7.11. Pediatria
    1. 7.12. Psichiatria / Psicosomatica
    1. 7.13. Radiologia
    1. 7.14. Chirurgia
      1. Chirurgia generale / viscerale
      1. Neurochirurgia
      1. Chirurgia plastica
      1. Chirurgia toracica
      1. Trauma / Ortopedia
      1. Chirurgia vascolare
    1. 7.15. Urologia
    1. 7.16. Medicina odontoiatrica / OMS
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NINDS CDE Vital Signs Headache - Vital Signs

- 20/06/16 - 1 modulo, 1 ItemGroup, 35 elementi, 1 linguaggio
ItemGroup: Vital Signs
NINDS Common Data Elements [Vital Signs][Headache] Used from the National Institute of Neurological Disorders and Stroke Common Data Elements (https://www.commondataelements.ninds.nih.gov/) References: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

Eligibility Multiple Sclerosis NCT02290444

- 23/09/21 - 1 modulo, 2 itemgroups, 16 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
Effects of Acthar on Recovery From Cognitive Relapses in MS; ODM derived from: https://clinicaltrials.gov/show/NCT02290444

Eligibility Posttraumatic Stress Disorders Multiple Sclerosis NCT01743664

- 15/06/21 - 1 modulo, 2 itemgroups, 10 elementi, 1 linguaggio
Itemgroups: Inclusion Criteria, Exclusion Criteria
The Efficacy of EMDR in Patients With PTSD in Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT01743664

Start-up Resource - NINDS Stroke CDE Recommendations - ODM-UMLS: Summary of Stroke CDE Recommendations

- 20/09/21 - 1 modulo, 3 itemgroups, 52 elementi, 2 lingue
Itemgroups: Core CDEs for all NINDs Studies, Core CDEs for Stroke Studies, Supplemental/Highly Recommended CDEs for Types of Stroke Studies
Modified Form Summary of Core/Supplemental - Highly Recommended or Supplemental Recommendations: Stroke CDEs Updated: October 13, 2015 This modified form used the National Institute of Neurological Disorders and Stroke Common Data Elements (http://www.commondataelements.ninds.nih.gov/) The National Institute of Neurological Disorders and Stroke (NINDS) and other Federal agencies and international organizations have the common mission of developing data standards for clinical research. Through the efforts of subject-specific working groups, topic-driven data elements have been created. References section: Grinnon ST, Miller K, Marler JR, Lu Y, Stout A, Odenkirchen J, Kunitz S. National Institute of Neurological Disorders and Stroke Common Data Element Project - approach and methods. Clin Trials. 2012;9(3):322-9.

Eligibility Relapsing Forms of Multiple Sclerosis NCT02097849

- 07/10/15 - 1 modulo, 2 itemgroups, 8 elementi, 1 linguaggio
Itemgroups: Criteria, Exclusion criteria
Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.; ODM derived from: https://clinicaltrials.gov/show/NCT02097849

Outcome event stroke Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521 - CABACS Case Report Form [Outcome event stroke]

- 07/03/16 - 1 modulo, 3 itemgroups, 28 elementi, 1 linguaggio
Itemgroups: Endpoint event "stroke", Stroke follow-up, Modified Rankin Scale,structured interview
Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis. A randomized controlled clinical trial. Short title: "CABACS" DRKS Number:DRKS00000521 IRSCTN Number:ISRCTN13486906 Phase:Therapeutic confirmatory(Phase III) Head of clinical trial: Prof. Dr. med. Christian Weimar University Duisburg-Essen Phone: 0201/723-6503 Fax: 0201/723-6948 e-mail: christian.weimar@uk-essen.de University Hospital Essen Hospital for Neurology Hufelandstr. 55 45122 Essen Trial coordinator: Dr. med. Stephan Knipp Phone: 0201/723-4915 Fax: 0201/723-5451 e-mail: stephan.knipp@uk-essen.de University Duisburg-Essen University Hospital Essen Hospital for thoracic- and cardiovascular surgery Hufelandstr. 55 45122 Essen Data Management: Anja Marr Phone: 0201/92239-257 Fax: 0201/92239-333 o. 0201/723-5933 e-mail: anja.marr@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen Monitoring: Dipl.-Biol. Konstantinos Bilbilis Phone: 0201/92239-252 Fax: 0201/92239-310 e-mail: konstantinos.bilbilis@uk-essen.de University Hospital Essen Center for clinical trials Essen c/o IMIBE Hufelandstr. 55 45122 Essen

Prodast Dabigatran NCT02507856 dropout

- 17/09/21 - 1 modulo, 1 ItemGroup, 12 elementi, 1 linguaggio
ItemGroup: Studienabbruch
Prospective Record Of the Use of Dabigatran in Patients With Acute Stroke or TIA (PRODAST) permission granted by Prof. Dr. Christian Weimar, University Hospital Essen The multi-center, prospective PRODAST study is investigating patients with non-valvular atrial fibrillation (AF) who experienced an ischemic stroke or a transient ischemic attack (TIA) recently (≤ 1 week) both with and without previous oral anticoagulation. This is the drop-out form. https://clinicaltrials.gov/ct2/show/NCT02507856

Prodast Dabigatran NCT02507856 Inclusion

- 17/09/21 - 1 modulo, 4 itemgroups, 37 elementi, 1 linguaggio
Itemgroups: Studieneinschluss, NIHSS und Modifizierte Rankin-Skala, Labor, Komplikationen zwischen Indexereignis und Studieneinschluss
Prospective Record Of the Use of Dabigatran in Patients With Acute Stroke or TIA (PRODAST) permission granted by Prof. Dr. Christian Weimar, University Hospital Essen The multi-center, prospective PRODAST study is investigating patients with non-valvular atrial fibrillation (AF) who experienced an ischemic stroke or a transient ischemic attack (TIA) recently (≤ 1 week) both with and without previous oral anticoagulation. This is the inclusion form containing NIHSS, Rankin-Scale, laboratory values and complications.

Prodast Dabigatran NCT02507856 zentral follow up

- 16/05/17 - 1 modulo, 13 itemgroups, 198 elementi, 1 linguaggio
Itemgroups: central follow up, Interview Patient/gesetzlicher Vertreter Allgemeine Fragen, Endpunkte I, Modifizierte Rankin-Skala (mRS), Endpunkte II, Endpunkte III, Antithrombotic Medication, Entlassmedikation abgesetzt, Neue antithrombotische Medikation, Die 10 letzten INR-Werte, AE und Bridging, Details, Befragungsende
Prospective Record Of the Use of Dabigatran in Patients With Acute Stroke or TIA (PRODAST) permission granted by Prof. Dr. Christian Weimar, University Hospital Essen The multi-center, prospective PRODAST study is investigating patients with non-valvular atrial fibrillation (AF) who experienced an ischemic stroke or a transient ischemic attack (TIA) recently (≤ 1 week) both with and without previous oral anticoagulation. This is the zentral follow up form. https://clinicaltrials.gov/ct2/show/NCT02507856

Prodast Dabigatran NCT02507856 final event

- 05/04/17 - 1 modulo, 1 ItemGroup, 44 elementi, 1 linguaggio
ItemGroup: Endpunkt-Ereignis
Prospective Record Of the Use of Dabigatran in Patients With Acute Stroke or TIA (PRODAST) permission granted by Prof. Dr. Christian Weimar, University Hospital Essen The multi-center, prospective PRODAST study is investigating patients with non-valvular atrial fibrillation (AF) who experienced an ischemic stroke or a transient ischemic attack (TIA) recently (≤ 1 week) both with and without previous oral anticoagulation. This is the final event form. https://clinicaltrials.gov/ct2/show/NCT02507856

Prodast Dabigatran NCT02507856 Serious Adverse Events

- 03/04/17 - 1 modulo, 10 itemgroups, 79 elementi, 1 linguaggio
Itemgroups: Adverse Events, Patient Characteristics, Site address, Adverse Event, Pregnancy, Details Antithrombotic Product, Details Further Antithrombotic Product, Concomitant Therapies, Concomitant diagnoses, Comments
Prospective Record Of the Use of Dabigatran in Patients With Acute Stroke or TIA (PRODAST) permission granted by Prof. Dr. Christian Weimar, University Hospital Essen The multi-center, prospective PRODAST study is investigating patients with non-valvular atrial fibrillation (AF) who experienced an ischemic stroke or a transient ischemic attack (TIA) recently (≤ 1 week) both with and without previous oral anticoagulation. This is the (serious) Adverse Events form. https://clinicaltrials.gov/ct2/show/NCT02507856

Prodast Dabigatran NCT02507856 Concomitant Therapy

- 03/04/17 - 1 modulo, 1 ItemGroup, 14 elementi, 1 linguaggio
ItemGroup: Concomitant Therapy
Prospective Record Of the Use of Dabigatran in Patients With Acute Stroke or TIA (PRODAST) permission granted by Prof. Dr. Christian Weimar, University Hospital Essen The multi-center, prospective PRODAST study is investigating patients with non-valvular atrial fibrillation (AF) who experienced an ischemic stroke or a transient ischemic attack (TIA) recently (≤ 1 week) both with and without previous oral anticoagulation. This is the Concomitant Therapy form. https://clinicaltrials.gov/ct2/show/NCT02507856

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