Zoekresultaten - Portaal voor medische datamodellen (MDM-portaal)

End period - Medications, Adverse Events, Transfusion History, Conclusion and Termination UK Essen Therapy of Chronic Cold Agglutinin Disease With Eculizumab NCT01303952

- 15-03-21 - 1 Formulier, 4 Itemgroepen, 32 Data-elementen, 2 Talen

Itemgroepen: Medications, Adverse Events, Transfusion history during the entry study, Conclusion of the Study and Termination

Study Type: Interventional Study Design: Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment Official Title: Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-Randomized Multi-Center Study Demonstrating the Efficacy of Terminal Complement Inhibition in Patients With Cold Agglutinin Disease Using Eculizumab EudraCT-Nummer 2009-01696697 ClinicalTrials.gov-Identifier NCT01303952 https://clinicaltrials.gov/ct2/show/NCT01303952 Genehmigung durch Frau Ose

Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858 - Transfusion Record

- 20-10-20 - 1 Formulier, 3 Itemgroepen, 15 Data-elementen, 1 Taal

Itemgroepen: Administrative Data, Transfusion during clinical trial, Transfusion

Study ID: 105043/013 Clinical Study ID: 105043/013 Study Title: An Open-Label Study of Argatroban Injection to Evaluate the Safety and Effectiveness in Pediatric Patients Requiring Anticoagulant Alternatives to Heparin (Protocol SKF105043/013) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00039858 - See https://clinicaltrials.gov/ct2/show/NCT00039858 Sponsor: GlaxoSmithKline Collaborators: Encysive Pharmaceuticals Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Argatroban Trade Name: N/A Study Indication: Thrombosis This Study evaluates the safety and the efficacy of i.v. Argatroban treatment in paediatric patients which require anticoagulants but aren't suitable for Heparin treatment. The study consists of screening visit (pre-treatment examination), treatment period of maximum 14 days after reaching therapeutical dose, post-treatment visit (once the treatment is stopped or after 14 days) and a follow-up visit which follows 30 days (+/- 14 days) after clinical resolution of underlying condition or after the end of the 14-day study period. Treatment can be continued after the 14-day study period if needed but such treatment isn't part of this Study. The Transfusion Record has to be filled in whenever any bleeding occurs during the Study.

Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961 - Blood Donation/Transfusion

- 16-10-19 - 1 Formulier, 3 Itemgroepen, 13 Data-elementen, 1 Taal

Itemgroepen: Administrative documentation, Pre-operative Blood Donation for Autotransfusion, Blood Transfusion Record

Study ID: 103414 Clinical Study ID: 103414 Study Title: A Multicenter, Randomized, Double-blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression (IPC) Versus IPC Used Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdominal surgery Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00038961 https://clinicaltrials.gov/ct2/show/NCT00038961 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Fondaparinux Sodium Trade Name: Fondaparinux Sodium Study Indication: Thrombosis This phase III placebo-controlled trial studies the efficacy and safety of Fondaparinux as an additional prevention measure of venous thromboembolic events (VTE) in patients above the age of 40 with intermediate or high VTE risk undergoing abdominal surgery. The study consists of a Screening Visit (Visit 0), the baseline visit on Day 1, the day of the surgery (Visit 1), the treatment period (denoted in its entirety as Visit 2) consisting of administration of Fondaparinux (2.5mg subcutaneously once daily) or placebo starting on Day 1 and continuing at least up to Day 5, possibly up to Day 9, in parallel to intermittent pneumatic compression and possibly elastic stockings, followed by a mandatory bilateral venography no longer than 24 hours after study drug cessation, and finally a Follow-up Visit (Visit 3) on Day 30 +/- 2. This form contains information on pre-operative blood donation as well as transfusions, and is to be filled in as appropriate during the study.

Sentinel Common Data Model - Inpatient Tranfusion

- 25-08-19 - 1 Formulier, 1 Itemgroep, 12 Data-elementen, 1 Taal

Itemgroep: Inpatient Transfusion

Sentinel: Overview and Description of the Common Data Model v7.0.0: "The primary goal of Sentinel is to build and operate a national public health surveillance system to monitor the safety of FDA-regulated medical products, including drugs, biologics, and devices. Sentinel is part of the Sentinel Initiative, the FDA’s response to a congressional mandate to create an active surveillance system using electronic health data.The Sentinel program will undertake three major types of activities: (1) prospective evaluation of accumulating experience about specific medical products and specific suspected safety problems; (2) evaluation of the impact of FDA actions (e.g., labeling changes) on medical practice and health outcomes; and (3) rapid assessment of past experience in response to FDA questions about specific exposures and outcomes." For more information about Sentinel visit the website at: www.sentinelsystem.org For comments and suggestions, please email: info@sentinelsystem.org The SCDM Demographic Table contains one record per PatID with the most recent information on birth date, sex, race/ethnicity, and ZIP code.

SB-681323 in ALI/ARDS risk patients - NCT00996840 - Blood Products

- 20-07-19 - 1 Formulier, 2 Itemgroepen, 9 Data-elementen, 1 Taal

Itemgroepen: Administrative documentation, Blood Products and Blood Supportive Care Products

Study ID: 111592 Clinical Study ID: 111592 Study Title: A Randomized, Double-blind, Placebo-controlled, Doseescalation Study to Assess the Anti-inflammatory Activity, Efficacy, and Safety of Intravenous SB-681323 in Subjects at Risk for Development of Acute Lung Injury or ARDS Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00996840 See https://clinicaltrials.gov/ct2/show/NCT00996840 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Placebo, SB-681323 Trade Name: N/A Study Indication: Lung Injury, Acute The primary objective of this phase 2 trial is to evaluate the safety and tolerability of intravenous dilmapimod/SB-681323 given in escalating dosages and over different intervals for three days in trauma patients at risk for the development of ALI or ARDS. This study consists of Screening, infusion of dilmapimod/SB-681323 on days 1-3, examination/sampling up to early day 5 (denoted as "Day 3 - 48 hrs") and a Follow-up on day 7. There are four cohorts, cohorts 1 and 3 receive the medication (or placebo) infusion over 4 hours, cohorts 2 and 4 over 24 hours. This form documents blood (products) and IV fluids given to the participant and is to be filled in repeatedly during the study, as appropriate.

Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer NCT00549328 - Cancer and Non-Cancer related surgical Procedures; Investigational Product; Blood Products and Blood Supportive Care Products; Date of Visit/ Assessment; Unscheduled Lesion Assessment; Follow-Up; Follow-Up Anti-Cancer Therapy; Follow-Up Radiotherapy

- 29-05-19 - 1 Formulier, 9 Itemgroepen, 54 Data-elementen, 1 Taal

Itemgroepen: Prior Cancer and Non-Cancer related surgical procedures, Investigational Product, Investigational Product - Dose Modifications, Blood Products and Blood Supportive Care Products, Date of visit/ Assessment, Unscheduled Lesion Assessment, Follow-Up, Follow-Up Anti-Cancer Therapy, Follow-Up Anti-Cancer Radiotherapy

Study ID: 109609 Clinical Study ID: 109609 Study Title: A Phase II, Non-randomized, Multi-center Study to Evaluate the Efficacy and Safety of Pazopanib (GW786034) in Subjects With Advanced Non-Small Cell Lung Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00549328 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GW786034 Trade Name: Drug: Pazopanib Study Indication: Lung Cancer, Non-Small Cell

Subcutaneous fondaparinux sodium for prevention of venous thromboembolic events; Study ID: 104619 - Blood Transfusion Record

- 28-08-18 - 1 Formulier, 2 Itemgroepen, 8 Data-elementen, 1 Taal

Itemgroepen: Pre-operative Blood Donation, Blood Transfusion Record

Study ID: 104619 Clinical Study ID: 63129 Study Title:A multinational, randomized, double-blind comparison of once daily subcutaneous fondaparinux sodium with placebo for the prevention of venous thromboembolic events in acutely ill medical patients (ARTEMIS). 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: fondaparinux sodium Trade Name: Arixtra Study Indication: Thrombosis, Venous

NCT00486954_Lapatinib in Combination With Weekly Paclitaxel in Patients With ErbB2 Amplified Advanced Gastric Cancer - Blood Products and Blood Supportive Care Products, Paclitaxel Premedications

- 30-05-18 - 1 Formulier, 2 Itemgroepen, 10 Data-elementen, 1 Taal

Itemgroepen: Blood Products and Blood Supportive Care Products, Paclitaxel Premedications

https://clinicaltrials.gov/ct2/show/NCT00486954 Study ID: 104578 Clinical Study ID: EGF104578 Study Title: A Randomized, Multicenter, Open-label, Phase III Study of Lapatinib (GW572016) in Combination with weekly Paclitaxel versus weekly Paclitaxel alone in the second line treatment of ErbB2 amplified Advanced Gastric Cancer Patient Level Data: Clinicaltrials.gov Identifier: NCT00486954 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Product Sponsorship Transferred to Novartis Generic Name: lapatinib Trade Name: Tyverb,Tykerb,Tycerb Study Indication: Neoplasms, Gastrointestinal Tract CRF Seiten: 1288-1609

Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy NCT00989664 - Infection Summary, Concomitant medications and Transfusions

- 24-05-18 - 1 Formulier, 2 Itemgroepen, 24 Data-elementen, 1 Taal

Itemgroepen: Infection Summary, Concomitant Medications & Transfusions

https://clinicaltrials.gov/show/NCT00989664 Infection Summary, Concomitant medications and Transfusions Study ID: 104504 Clinical Study ID: BEX104504 Study Title: Multicenter, Pivotal Phase III Study of Iodine-131 Anti-B1 Antibody (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas that have Transformed to Higher Grade Histologies Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00989664 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: tositumomab Trade Name: Bexxar Study Indication: Lymphoma, Non-Hodgkin

GSK Study ID 104864-201 Supportive Therapies-Transfusions, Anti-Infectives and Concominant Medication - Supportive Therapies-Transfusions, Anti-Infectives and Concominant Medication

- 24-04-18 - 1 Formulier, 6 Itemgroepen, 23 Data-elementen, 1 Taal

Itemgroepen: Identification Numbers, Supportive Therapy Transfusion, If Yes to Supportive Therapy (Including Erythropoietin), Supportive Anti-Infective Therapy, If Yes to Supportive Anti-Infective Therapy, Concominant Medication

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 https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

Transfusion

- 29-08-17 - 1 Formulier, 1 Itemgroep, 7 Data-elementen, 1 Taal

Itemgroep: Transfusion

The patient's received transfusions. Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=AD24E1F2-5135-264F-E040-BB89AD430ED7

Input Data Elements CDSS Blood Transfusion Mangement Loftus 2015

- 13-10-16 - 1 Formulier, 1 Itemgroep, 3 Data-elementen, 1 Taal

Itemgroep: Transfusion management criteria

Input Data Elements CDSS for Blood Transfusion Mangement:Does a patient blood management program implemented for patients undergoing total knee arthroplasty (TKA) or total hip arthroplasty (THA) result in improvement of clinical outcomes Published by Loftus et al. 2015

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