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  1. 1. Essai clinique
  2. 2. Routinedokumentation
  3. 3. Études de registres/cohortes
  4. 4. Assurance qualité
  5. 5. Standard de données
  6. 6. Questionnaire pour les patients
  7. 7. Spécialité médicale
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Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course 3 Prior to next Course (Day 25 - 28) - Review of Disease Status; Therapeutic Interventions; End of Course Eligibility; Unscheduled Laboratory Tests; Therapeutic Interventions Log

- 01/09/2019 - 1 Formulaire, 7 Groupes Item, 22 Eléments de données, 1 Langue
Groupes Item: Administrative, Review of Disease Status, Therapeutic Interventions, End of Course Eligibility, Unscheduled Laboratory Tests - Hematology, Unscheduled Laboratory Tests - Hematology, Therapeutic Interventions
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course 2 Prior to next Course (Day 25 - 28) - Review of Disease Status; Therapeutic Interventions; End of Course Eligibility; Unscheduled Laboratory Tests; Therapeutic Interventions Log

- 30/08/2019 - 1 Formulaire, 7 Groupes Item, 22 Eléments de données, 1 Langue
Groupes Item: Administrative, Review of Disease Status, Therapeutic Interventions, End of Course Eligibility, Unscheduled Laboratory Tests - Hematology, Unscheduled Laboratory Tests - Hematology, Therapeutic Interventions
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Course 1 Prior to next Course (Day 25 - 28) - Review of Disease Status; Therapeutic Interventions; End of Course Eligibility; Unscheduled Laboratory Tests; Therapeutic Interventions Log

- 30/08/2019 - 1 Formulaire, 7 Groupes Item, 22 Eléments de données, 1 Langue
Groupes Item: Administrative, Review of Disease Status, Therapeutic Interventions, End of Course Eligibility, Unscheduled Laboratory Tests - Hematology, Unscheduled Laboratory Tests - Hematology, Therapeutic Interventions
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Intravenous Topotecan and Gemcitabine as Second-line Treatment in Patients With Ovarian Cancer NCT00061308 - Eligibility Criteria

- 20/08/2019 - 1 Formulaire, 3 Groupes Item, 22 Eléments de données, 1 Langue
Groupes Item: Inclusion Criteria, Exclusion Criteria, Did the patient meet all inclusion and exclusion criteria?
Study ID: 104864/627 Clinical Study ID: 104864/627 Study Title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00061308 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan, Gemcitabine Study Indication: Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian, Fallopian Tube Cancer

Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612 - Prior to Second Cycle

- 13/08/2019 - 1 Formulaire, 5 Groupes Item, 12 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, X-Ray Computed Tomography, Response to treatment, Evaluation, Serious Adverse Event, Clinical Trials, Status
Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: HycamtinTM Study Indication: Ovarian Cancer

HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173 - Investigator's Signature

- 15/07/2019 - 1 Formulaire, 2 Groupes Item, 4 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Investigator Signature
Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

HYCAMTIN in Combination With Carboplatin in Subjects with Ovarian Cancer; NCT00316173 - End of Treatment

- 12/07/2019 - 1 Formulaire, 7 Groupes Item, 40 Eléments de données, 1 Langue
Groupes Item: Administrative documentation, Vital Signs, Lesion, Indicator, Evaluation, Non-Measurable Lesion, Evaluation, Response to treatment, Evaluation, Laboratory Procedures, Hematology finding, Laboratory Procedures, Chemistry, Clinical
Study ID: 104864/902 Clinical Study ID: 104864/902 Study Title: An Open-Label, Single-Arm, Phase II Study of IV Weekly (Days 1 and 8 Every 21 Days) HYCAMTIN in Combination With Carboplatin (Day 1 Every 21 Days) as Second-Line Therapy in Subjects With Potentially Platinum-Sensitive Relapsed Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00316173 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: CARBOPLATIN Study Indication: Ovarian Cancer; Neoplasms, Ovarian

Oral GW786034 treatment for ovarian cancer NCT00281632 - Additional Forms

- 03/06/2018 - 1 Formulaire, 24 Groupes Item, 95 Eléments de données, 1 Langue
Groupes Item: Header, investigational product discontinuation, PGx-Pharmacogenetic Research, Concomitant Medications, If Yes to Concominant Medication, Non-serious adverse events, Non-serious adverse events, Serious adverse event, Serious adverse events description, Seriousness, Document section Demography data, SECTION 4, Section 5, Relevant Medical Conditions, Document section Risk factors, Document section Concomitant Medications, Drug Details, Assessments, Document section, Pregnancy information, Death, Study Conclusion, Investigator comment log, Investigators Signature
Study ID: 104450 Clinical Study ID: VEG104450 Study Title: This study is a non-randomized, open-label, multi-center Phase II study of GW786034 to evaluate the administration of oral GW786034 in subjects with ovarian cancer. Clinicaltrials.gov Identifier: NCT00281632 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib Trade Name: Votrient Study Indication: Neoplasms, Ovarian CRF Pages: 722-853

Visit 12 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 12

- 17/02/2016 - 1 Formulaire, 5 Groupes Item, 48 Eléments de données, 1 Langue
Groupes Item: Visit 12: Fourth cycle of post-OP Chemotherapy, Status of Patient and recording of CTCAE, Postoperative intravenous chemotherapy, Course of chemotherapy cycle, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 14 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 14

- 17/02/2016 - 1 Formulaire, 5 Groupes Item, 48 Eléments de données, 1 Langue
Groupes Item: Visit 14: Sixth cycle of post-OP Chemotherapy, Status of Patient and recording of CTCAE, Postoperative intravenous chemotherapy, Course of chemotherapy cycle, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 13 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 13

- 17/02/2016 - 1 Formulaire, 5 Groupes Item, 48 Eléments de données, 1 Langue
Groupes Item: Visit 13: Fifth cycle of post-OP Chemotherapy, Status of Patient and recording of CTCAE, Postoperative intravenous chemotherapy, Course of chemotherapy cycle, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

Visit 11 Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv - Case Report Form (HIPEC) Visit 11

- 17/02/2016 - 1 Formulaire, 5 Groupes Item, 48 Eléments de données, 1 Langue
Groupes Item: Visit 11: Third cycle of post-OP Chemotherapy, Status of Patient and recording of CTCAE, Postoperative intravenous chemotherapy, Course of chemotherapy cycle, Confirmation of correctness
Phase 1 clinical trial for intrasurgical hyperthermic intraperitoneal chemoperfusion with cisplatin (HIPEC) in patients with ovarian cancer recidiv EudraCT Nr.: 2010-024352-28 Principal investigator und authorized representative of Sponsor: PD Dr. med. Oliver Zivanovic Center for Obstetrics and Gynaecology University Hospital Bonn Sigmund-Freud-Str. 25 53105 Bonn Sponsor: Rheinische Friedrich-Wilhelms-Universität Bonn represented by the Dean of Medical Faculty

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