Risultati di ricerca - Portale di modelli di dati medici (MDM-Portal)

End of Study SirTac NCT02936388 - End of Study

- 03/12/17 - 1 modulo, 1 ItemGroup, 16 elementi, 1 linguaggio

ItemGroup: Study End

Study part: End of Study. 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.

Staging PETAL Study NCT00554164 - Staging

- 18/11/16 - 1 modulo, 9 itemgroups, 60 elementi, 2 lingue

Itemgroups: Patient demographics, Therapy, Staging, Lab results, Nodal involvement, Extranodal involvement, Overall result, IPI, Footer module

Positronen-Emissionstomographie-gesteuerte Therapie aggressiver Non-Hodgkin-Lymphome (PETAL-Studie) Universitätsklinikum Essen (UK Essen) EudraCT-Nummer: 2006-001641-33 NCT00554164

Present aftercare Physician’s questionnaire for aftercare ABC study - Present aftercare Physician’s questionnaire for aftercare

- 20/09/21 - 1 modulo, 11 itemgroups, 99 elementi, 1 linguaggio

Itemgroups: Administrative, Medical Examination, Medical consultation, laboratory tests, Aftercare, medical consultation early cancer prevention, vaccination status, cardiovascular risk factor, Rehabilitation measures, Physical therapy, Medication

Study part: Present aftercare Physician’s questionnaire for aftercare ABC Study. Aftercare pattern in adult patients with blood cancer and blood cancer early stage: Impact on health related endpoints, quality of life and health resource use. University clinic essen, (Klinik für Hämatologie Uniklinik Essen, UKE), department hematology. Permission granted by Claudia Ose.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - End of Study

- 30/03/21 - 1 modulo, 5 itemgroups, 23 elementi, 1 linguaggio

Itemgroups: Administrative Data, Pregnancy information, End of study, End of study details, Signature

Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. Per protocol, subjects are to be followed until the subject completes the observation phase, the subject withdraws consent or the subject dies. Subjects who do not complete the treatment phase, should be followed until they complete the observation phase, withdraw consent or die. This form has to be filled out at the end of study/ end of treatment.

GSK Ofatumumab in Waldenstrom Macroglobulinaemia, NCT00811733 - Study Treatment

- 22/02/21 - 1 modulo, 5 itemgroups, 32 elementi, 1 linguaggio

Itemgroups: Administrative Data, Pre-Medications, Ofatumumab Infusion Summary Details, Infusion Vitals Details Entry, Treatment Confirmation

Study ID: 110921 Clinical Study ID: 110921 Study Title: A Phase II Trial of Ofatumumab in Subjects with Waldenstrom's Macroglobulinemia Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00811733 Clinicaltrials.gov Link: https://clinicaltrials.gov/ct2/show/NCT00811733 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Ofatumumab Trade Name: N/A Study Indication: Waldenstrom Macroglobulinaemia The primary objective of this open-label, multi-center, Phase II study was to evaluate the safety and efficacy of Ofatumumab in subjects diagnosed with Waldenstrom Macroglobulinaemia. For the study, eligible subjects were enrolled to receive up to 3 cycles of treatment with Ofatumumab. The first cycle consisted of a single dose of 300 mg followed by 3 weekly doses of 1000 mg (Treatment Group A) or 4 weekly doses of 2000 mg (Treatment Group B) of Ofatumumab, with response assessment beginning at Week 12. Based on the Week 12-16 response, eligible subjects could receive up to 2 additional cycles of treatment. This form has to be filled out at the weekly visits during the treatment cycles.

General aspects Physician’s questionnaire for aftercare ABC study - General aspects Physician’s questionnaire for aftercare

- 24/10/16 - 1 modulo, 4 itemgroups, 45 elementi, 1 linguaggio

Itemgroups: Administrative, Comorbidity, Aftercare, Aftercare importance

Study part: General aspects Physician’s questionnaire for aftercare ABC Study. Aftercare pattern in adult patients with blood cancer and blood cancer early stage: Impact on health related endpoints, quality of life and health resource use. University clinic essen, (Klinik für Hämatologie Uniklinik Essen, UKE), department hematology. Permission granted by Claudia Ose.

Comorbidities at study end LeMLAR-Studie Lymphoma NCT01788189 - Comorbidities at study end

- 22/09/16 - 1 modulo, 1 ItemGroup, 9 elementi, 1 linguaggio

ItemGroup: Comorbidity

Study part: Comorbidities at study end LeMLAR-Studie. Lenalidomide in conjunction with methotrexate, leucovorin, cytarabine and rituximab for the treatment of relapsed or refractory CD20-positive aggressive lymphomas: an open-label, multicenter phase I/II trial. Publication granted by Prof. Dührsen and provided by Claudia Ose, University clinic Essen, NCT01788189, Version 1.3-28.04.2013.doc.

Safety and Efficacy of Argatroban in Pediatric Patients, NCT00039858 - Study Completion

- 14/09/20 - 1 modulo, 5 itemgroups, 25 elementi, 1 linguaggio

Itemgroups: Administrative Data, Completion of study by subject, Study completed by subject, Study not completed by subject, Investigator's Signature

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 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. See https://clinicaltrials.gov/ct2/show/NCT00039858 This Form is to be completed on Study Conclusion and is used to verify that no important steps were omitted. Also includes Investigator's Signature.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Adverse events

- 23/01/21 - 1 modulo, 2 itemgroups, 27 elementi, 1 linguaggio

Itemgroups: Administrative Data, Adverse events

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This document is to be filled out if and whenever an adverse event occurs during the study period.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Pharmacogenetic Research

- 09/01/21 - 1 modulo, 3 itemgroups, 14 elementi, 1 linguaggio

Itemgroups: Administrative Data, PGx-Pharmacogenetic Research Consent, PGx-Pharmacogenetic Research Withdrawal of Consent

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out by all participants to document, whether pharmacogenetic research consent is either given, not given or withdrawn after it had been previously given.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Concomitant medication

- 09/01/21 - 1 modulo, 2 itemgroups, 16 elementi, 1 linguaggio

Itemgroups: Administrative Data, Concomitant Medications

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out, if concomitant medication has been taken by subject during the study.

GSK Eltrombopag Thrombocytopenia, Clinical Study ID: 105122 - Study Conclusion and Pregnancy Information

- 18/12/20 - 1 modulo, 3 itemgroups, 11 elementi, 1 linguaggio

Itemgroups: Administrative Data, Study Conclusion, Pregnancy information

The primary objective of this study was to demonstrate bioequivalence between eltrombopag oral film-coated tablets manufactured at Research and Development (R&D) and Commercial sites. The subject participants each went through two dosing periods (Period 1 and Period 2), during each of which they received a single dose of eltrombopag. The dosing periods were separated by a washout of at least 10 days. For each period, subjects had to perform a visit on the day before and one on the day of the administration of the drug. Furthermore, the protocol-defined visits included a screening visit and a follow-up visit. Study ID: 105122 Clinical Study ID: 105122 Study Title: Phase I Bioequivalence Study for SB 497115 GR Phase II and Phase III Tablets Sponsor: GlaxoSmithKline Phase: phase 1 Study Recruitment Status: Completed Generic Name: Eltrombopag Study Indication: Thrombocytopenia This form has to be filled out at the Follow-Up Visit.

Keywords

Sommario

Modelli di dati selezionati