Resultados da pesquisa - Portal para modelos de dados médicos (portal MDM)

Sumatriptan pharmacokinetics TREXIMA and IMITREX tablet ID 106396 - Investigational Product, Treatment Confirmation, Randomisation-Number

- 11/10/2018 - 1 Formulário, 4 Grupos de itens, 9 Elementos de dados, 1 Idioma

Grupos de itens: Administrative Data, Investigational Product, Treatment Confirmation, Randomisation Number (Only Period 1)

This ODM file contains the form to document the investigational product, the treatment confirmation and the randomisation-number. To be assessed at Day 1 of Period 1 and 2 (randomisation number only at Period 1). Study ID: 106396 Clinical Study ID: TRX106396 Study Title: An open-label, randomized, single-dose, 2-period crossover study to evaluate sumatriptan pharmacokinetics for a TREXIMA™(sumatriptan 85mg and naproxen sodium 500mg)*, Tablet compared with an IMITREX® (sumatriptan) 100mg Tablet 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: sumatriptan Trade Name: Imitrex ,Imiject ,Imigran; Imitrex,Imiject,Imigran Study Indication: Migraine Disorders Sponsor: GlaxoSmithKline

Fondaparinux sodium (Arixtra) versus unfractionated heparin with patients undergoing PCI; Clinical Study ID: AR1104574 - Randomization Form

- 13/08/2018 - 1 Formulário, 3 Grupos de itens, 22 Elementos de dados, 1 Idioma

Grupos de itens: Administrative Data, Eligibility Determination, Randomization

Study ID: 104574 Clinical Study ID: AR1104574 Study Title: A randomized blinded pilot trial of fondaparinux sodium (Arixtra®) versus unfractionated heparin in addition to standard therapy in a broad range of patients undergoing percutaneous coronary intervention (ASPIRE) 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: fondaparinux sodium Trade Name: Arixtra Study Indication: Thromboembolism

Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454 - Randomisation, Investigational Product and Treatment Confirmation (Sessions 1 and 2)

- 27/06/2018 - 1 Formulário, 4 Grupos de itens, 9 Elementos de dados, 1 Idioma

Grupos de itens: Administrative Data, Randomisation Number, Investigational Product, Treatment Confirmation

This ODM file contains Randomisation Number, Investigational Product Date and Time and Treatment Confirmation. To be filled at Sessions 1 and 2 (Day 1; Randomisation only at Session 1). Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

Safety of once-daily administration of Fluticasone nasal spray in adults and adolescents with perennial allergic rhinitis GSK 102123 - Administrative Data - Visit 2

- 18/05/2018 - 1 Formulário, 4 Grupos de itens, 10 Elementos de dados, 1 Idioma

Grupos de itens: Administrative Data, Randomisation Criteria, Randomisation Number, Investigational Product Container Number

Study ID: 102123 Clinical Study ID: FFR102123 Study Title: A randomised double-blind placebo controlled parallel group multicentre long term study to evaluate the safety of once-daily, intranasal administration of GW685698X aqueous nasal spray 100mcg* for 52 weeks in adult and adolescent subjects with perennial allergic rhinitis. 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: fluticasone furoate Trade Name: FLUTIDE, Allermist, Veramyst, FLUNASE, FLIXOTAIDE, FLUTAIDE, FLIXOVATE, Avamys; Veramyst, Avamys, Allermist Study Indication: Rhinitis, Allergic, Perennial This ODM-file contains Administrative Data; Visit 2, Week 0, Day 1.

Day 0- Randomization SirTac NCT02936388 - Day 0- Randomization

- 26/11/2017 - 1 Formulário, 1 Grupo de itens, 8 Elementos de dados, 1 Idioma

Grupo de itens: Randomization

Study part: Day 0- Randomization. A Randomized Phase II Trial of Transarterial Radioembolisation With Yttrium-90 (SIRT) in Comparison to Transarterial Chemoembolisation With Cisplatin (TACE) in Patients With Liver Metastases From Uveal Melanoma. Provided by Prof. Dr. Ulrich Keilholz, Charité – University of medicine Berlin. EudraCT-Nummer: 2014-002439-32. NCT02936388.

Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC) - Patientenrandomisation

- 21/11/2017 - 1 Formulário, 4 Grupos de itens, 42 Elementos de dados, 2 Idiomas

Grupos de itens: Administrative Documentation, Inclusion Criteria, Exclusion Criteria, Staging | stratification factors

Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction NCT-Identifier: NCT02158988 Source: Prof. Dr. med. Beate Rau, MBA Charité Universitätsmedizin Berlin Studien-Patientenidentifikation Bitte tragen Sie den Patienten in die Patientenidentifikationsliste (PIL) in Ihrem Investigator Site File (ISF) ein , um dem Patienten eine Pat-ID zuzuweisen. Bitte faxen Sie die Seiten R_01 und R_02 umgehend an die Studienzentrale der Charité : 030 – 450 7 522 214

Day 2 GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

- 18/10/2017 - 1 Formulário, 10 Grupos de itens, 13 Elementos de dados, 1 Idioma

Grupos de itens: STUDY MEDICATION RECORD SINCE LAST VISIT, CHECK FOR STUDY CONTINUATION, RLS RATING SCALE, VITAL SIGNS, MEDICAL PROCEDURES, CONCOMITANT MEDICATION, ADVERSE EXPERIENCES, CLINICAL GLOBAL IMPRESSION (CGI): EFFICACY INDEX, CLINICAL GLOBAL IMPRESSION, RAMOS RANDOMISATION AND DISPENSING

Study ID: 101468/190 Clinical Study ID: SKF-101468/190 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 This is the Day 2 form.

Visit 2 Baseline Randomization [RD_1] NCT01117584

- 28/01/2017 - 1 Formulário, 1 Grupo de itens, 3 Elementos de dados, 1 Idioma

Grupo de itens: 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.

Patient randomization form Coronary Artery Bypass graft surgery in patients with Asymptomatic Carotid Stenosis DRKS00000521 - CABACS Case Report Form [Patient randomization form]

- 26/02/2016 - 1 Formulário, 1 Grupo de itens, 18 Elementos de dados, 1 Idioma

Grupo de itens: Patient randomization form

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

CWS-2007-HR Randomisierung DRKS00003774 - Randomisierung

- 06/08/2014 - 1 Formulário, 2 Grupos de itens, 5 Elementos de dados, 2 Idiomas

Grupos de itens: Anzeige Namen auf Formular, Randomisierung

CWS-2007-HR: A randomised phase-III trial of the Cooperative Soft-Tissue-Study-Group for localised high-risk rhabdomyosarcoma and localised Rhabdomyosarcoma-like Soft Tissue Sarcoma in children, adolescents, and young adults http://clinicaltrials.gov/show/NCT00876031 http://www.cws.olgahospital-stuttgart.de

Ewing Study Randomisierung DRKS00003588 - Randomisierung

- 04/08/2014 - 1 Formulário, 6 Grupos de itens, 52 Elementos de dados, 2 Idiomas

Grupos de itens: Show identification of patient, Anforderung/Risikogruppe, R1, R2loc, R2pulm, R3

EWING 2008, EudraCT 2008-003658-13, http://clinicaltrials.gov/ct2/show/NCT00824083

Ewing Study Rando ergebnis DRKS00003588 - Rando ergebnis

- 04/08/2014 - 1 Formulário, 2 Grupos de itens, 3 Elementos de dados, 2 Idiomas

Grupos de itens: Show identification of patient, Ergebnis