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Eligibility Schizophrenia NCT01810783

- 2020-11-24 - 1 Formulär, 2 Item-grupper, 8 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Brexpiprazole in Patients With Schizophrenia; ODM derived from: https://clinicaltrials.gov/show/NCT01810783 according to the information on www.clinicaltrials.gov other inclusion and exclusion criteria may apply.

Efficacy of P. Falciparum Vaccine Against Malaria in Children NCT00380393 - Eligibility

- 2021-07-08 - 1 Formulär, 4 Item-grupper, 19 Dataelement, 1 Språk
Item-grupper: Administrative, Eligibility Check, Inclusion Criteria, Exclusion Criteria
Study ID: 106464 Clinical Study ID: 106464 Study Title: A Study of the Efficacy Against Episodes of Clinical Malaria Due to P. Falciparum Infection of GSK Biologicals Candidate Vaccine RTS, S/AS01, Administered According to a 0,1,2-months Schedule in Children Aged 5 to 17 Months Living in Tanzania & Kenya Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00380393 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK malaria vaccine 257049 Vaccine, Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine Trade Name: N/A Study Indication: Malaria ODM derived from https://clinicaltrials.gov/ct2/show/study/NCT00380393. This Phase IIb randomized, double-blind, controlled study of the efficacy against episodes of clinical malaria due to Plasmodium falciparum infection of GlaxoSmithKline Biologicals’ candidate vaccine RTS, S/AS01E, administered IM according to a 0, 1, 2-month vaccination schedule in children aged 5 months to 17 months living in Tanzania and Kenya. This study includes the following 7 clinical study visits (3 different visit types) during a double-blind phase (Day -60 to Month 6 1/2) and a single-blind phase including an extension for a subset of patients (month 7 to month 14). Clinical visit 1: Baseline visit, screening, and randomisation (DAY -60 to 0) Clinical visit 2: Vaccination I (MONTH 0, DAY 0 | DOSE 1 | 0 - 60 DAYS AFTER VISIT 1) Clinical visit 3: Vaccination II (MONTH 1, DAY 30 | DOSE 2 | 21 - 35 DAYS AFTER VISIT 2) Clinical visit 4: Vaccination III (MONTH 2, DAY 60 | DOSE 3 | 21 - 35 DAYS AFTER VISIT 3) Clinical visit 5: Blood Sample, ACD (MONTH 3, DAY 90 | 21 - 42 DAYS AFTER VISIT 4) Clinical visit 6: Blood Sample, ACD (MONTH 6 1/2 | CROSS-SECTIONAL VISIT FOR ACD | FINAL STUDY VISIT FOR DOUBLE-BLIND PHASE) Clinical visit 7: Blood Sample, ACD (MONTH 14 | FINAL STUDY VISIT SINGLE-BLIND PHASE) Field-worker home visits: During the vaccination period, clinical visits are accompanied by daily field-worker visits for a one-week period subsequent to each vaccine administration at clinical visits 2, 3, and 4 (visit code 21-26 following clinical visit 2; visit code 27-32 following clinical visit 3; visit code 33-38 following clinical visit 4). After completion of the vaccination period, clinical visits are then accompanied by weekly field-worker home visits (visit code 39-40 following clinical visit 4/dose 3; visit code 41-55 following clinical visit 5; visit code 56-86 following clinical visit 6). These visits serve the additional purpose of Active Case Detection (ACD). Passive Case Detection (PCD) for clinical malaria disease is performed both during the course of the double-blind (day -60 to month 6 1/2) and the single-blind phase (month 7 to month 14). Eligibility Criteria should be checked at visit 1 (screening) and visit 2. The Eligibility Criteria form is to be filled in at the screening visit. A check at visit 2 does not require documentation in the individual CRF. Note that informed consent has to be obtained prior to any study procedure.

Eligibility Osteoarthritis NCT01895413

- 2020-05-01 - 1 Formulär, 2 Item-grupper, 10 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Autologous Bone Marrow Mesenchymal Stem Cells Transplantation for Articular Cartilage Defects Repair; ODM derived from: https://clinicaltrials.gov/show/NCT01895413

Eligibility Nasopharyngeal Carcinoma NCT01712919

- 2020-04-25 - 1 Formulär, 2 Item-grupper, 11 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Chemoradiation Plus Weekly c225 Against Locoregionally Advanced Nasopharyngeal Carcinoma (NPC); ODM derived from: https://clinicaltrials.gov/show/NCT01712919

Eligibility Myelomonocytic Leukemia NCT01776723

- 2020-10-31 - 1 Formulär, 2 Item-grupper, 18 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Ruxolitinib; ODM derived from: https://clinicaltrials.gov/show/NCT01776723

Eligibility Non-Small Cell Lung Cancer NCT02468661

- 2020-04-25 - 1 Formulär, 2 Item-grupper, 9 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET Amplification; ODM derived from: https://clinicaltrials.gov/show/NCT02468661

Efficacy of P. Falciparum Vaccine Against Malaria in Children NCT00380393 - Elimination Criteria and Contraindications to Vaccination

- 2021-07-26 - 1 Formulär, 4 Item-grupper, 13 Dataelement, 1 Språk
Item-grupper: Administrative, Elimination Criteria, Contraindications to subsequent vaccination, Absolute contraindications to vaccination
Study ID: 106464 Clinical Study ID: 106464 Study Title: A Study of the Efficacy Against Episodes of Clinical Malaria Due to P. Falciparum Infection of GSK Biologicals Candidate Vaccine RTS, S/AS01, Administered According to a 0,1,2-months Schedule in Children Aged 5 to 17 Months Living in Tanzania & Kenya Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00380393 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: GSK malaria vaccine 257049 Vaccine, Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine Trade Name: N/A Study Indication: Malaria ODM derived from https://clinicaltrials.gov/ct2/show/study/NCT00380393. This Phase IIb randomized, double-blind, controlled study of the efficacy against episodes of clinical malaria due to Plasmodium falciparum infection of GlaxoSmithKline Biologicals’ candidate vaccine RTS, S/AS01E, administered IM according to a 0, 1, 2-month vaccination schedule in children aged 5 months to 17 months living in Tanzania and Kenya. This study includes the following 7 clinical study visits (3 different visit types) during a double-blind phase (Day -60 to Month 6 1/2) and a single-blind phase including an extension for a subset of patients (month 7 to month 14). Clinical visit 1: Baseline visit, screening, and randomisation (DAY -60 to 0) Clinical visit 2: Vaccination I (MONTH 0, DAY 0 | DOSE 1 | 0 - 60 DAYS AFTER VISIT 1) Clinical visit 3: Vaccination II (MONTH 1, DAY 30 | DOSE 2 | 21 - 35 DAYS AFTER VISIT 2) Clinical visit 4: Vaccination III (MONTH 2, DAY 60 | DOSE 3 | 21 - 35 DAYS AFTER VISIT 3) Clinical visit 5: Blood Sample, ACD (MONTH 3, DAY 90 | 21 - 42 DAYS AFTER VISIT 4) Clinical visit 6: Blood Sample, ACD (MONTH 6 1/2 | CROSS-SECTIONAL VISIT FOR ACD | FINAL STUDY VISIT FOR DOUBLE-BLIND PHASE) Clinical visit 7: Blood Sample, ACD (MONTH 14 | FINAL STUDY VISIT SINGLE-BLIND PHASE) Field-worker home visits: During the vaccination period, clinical visits are accompanied by daily field-worker visits for a one-week period subsequent to each vaccine administration at clinical visits 2, 3, and 4 (visit code 21-26 following clinical visit 2; visit code 27-32 following clinical visit 3; visit code 33-38 following clinical visit 4). After completion of the vaccination period, clinical visits are then accompanied by weekly field-worker home visits (visit code 39-40 following clinical visit 4/dose 3; visit code 41-55 following clinical visit 5; visit code 56-86 following clinical visit 6). These visits serve the additional purpose of Active Case Detection (ACD). Passive Case Detection (PCD) for clinical malaria disease is performed both during the course of the double-blind (day -60 to month 6 1/2) and the single-blind phase (month 7 to month 14). Elimination criteria during the study: The criteria should be checked at each visit subsequent to the first visit. If any become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject’s evaluability in the according-to-protocol (ATP) analysis. Contraindications to subsequent vaccination – indications for deferral of vaccination: The events constitute contraindications to administration of RTS,S/AS01E or Rabies vaccine at that point in time; if any one of these AEs occur at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. Contraindications to subsequent vaccination – absolute contraindications to further vaccination: The AEs constitute absolute contraindications to further administration of, RTS,S/AS01E or Rabies vaccine; if any of these AEs occur during the study, the subject must not receive additional doses of vaccine, but may continue other study procedures at the discretion of the investigator. It is expected that the subject would continue full safety monitoring procedures, as per protocol:

Eligibility Multiple Myeloma NCT02248428

- 2020-10-26 - 1 Formulär, 2 Item-grupper, 13 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Clarithromycin Plus CTd Regimen for Patients With Newly Diagnosed Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02248428

Eligibility Type 2 Diabetes Weight Loss NCT01601574

- 2021-06-23 - 1 Formulär, 2 Item-grupper, 39 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Weight Loss Study for People With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT01601574

Eligibility Non-Small-Cell Lung Cancer NCT00049998

- 2021-09-20 - 1 Formulär, 2 Item-grupper, 16 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00049998

Eligibility Non-Small Cell Lung Cancer NCT01423760

- 2021-09-20 - 1 Formulär, 2 Item-grupper, 9 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
Collect Long-term Data on Subjects Following Participation in Previous EMD 531444 (L-BLP25 or BLP25 Liposome Vaccine) Clinical Trials; ODM derived from: https://clinicaltrials.gov/show/NCT01423760

Eligibility Leukemia, Lymphocytic, Chronic NCT00038415

- 2021-09-20 - 1 Formulär, 2 Item-grupper, 16 Dataelement, 1 Språk
Item-grupper: Inclusion Criteria, Exclusion Criteria
A Phase I/II Trial of Idiotypic Vaccination for Chronic Lymphocytic Leukemia Using a Genetic Approach; ODM derived from: https://clinicaltrials.gov/show/NCT00038415

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