Suchergebnisse - Portal für Medizinische Datenmodelle (MDM-Portal)

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Screening - MAGE-A3 Expression Test; Tumor Sample (For Re-Test); MAGE-A3 Expression Re-Test; Prior Surgery; Prior Therapy (Annex Report 2 Final)

- 17.09.21 - 1 Formular, 9 Itemgruppen, 51 Datenelemente, 1 Sprache

Itemgruppen: Administrative, MAGE-A3 Expression Test, Tumor Sample (For Re-Test), MAGE-A3 Expression Re-Test, Prior Surgery, Prior Surgery Type, Prior Surgery, Prior Therapy, Prior treatment with systemic immunosuppressants

Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Questionnaire Oral and maxillofacial surgery - Questionnaire

- 17.09.21 - 1 Formular, 2 Itemgruppen, 14 Datenelemente, 2 Sprachen

Itemgruppen: Patient demographics, Insurance

Questionnaire converted to ODM format. Routine documentation of University Hospital of Münster. Publication granted by surgery Prof. Dr. Edgar Schäfer

QKEP 16 Prozedur MS University Hospital Muenster (UKM) Subform

- 15.06.21 - 1 Formular, 1 Itemgruppe, 14 Datenelemente, 1 Sprache

Itemgruppe: Prozedur

Hospital Routine Documentation Subform at the University Hospital Muenster. Original Form name: QKEP 16 Prozedur.

Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961 - Serious Adverse Event

- 15.03.21 - 1 Formular, 10 Itemgruppen, 29 Datenelemente, 1 Sprache

Itemgruppen: Administrative documentation, Demographic Information, Description, Study Drug, Hospitalization, Death, Previous and Concomitant Medication, Medical History and Concomitant Disease, SAE Follow-Up Information, Investigator & Monitor

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 serious adverse events, and is to be filled in as necessary during the study, in addition to the AE form, and consists of a complimentary part and a follow-up part.

Clinical activity of recMAGE-A3 + AS15 in patients with metastatic cutaneous melanoma NCT00942162 - Radiotherapy; Local Surgery (Report Final and Annex Report 2 Final)

- 30.10.20 - 1 Formular, 5 Itemgruppen, 17 Datenelemente, 1 Sprache

Itemgruppen: Administrative, Radiotherapy, Radiotherapy , Local Surgery, Local Surgery

Study ID: 111476 Clinical Study ID: 111476 Study Title: An open, single-arm trial to assess the clinical activity of recMAGE-A3 + AS15 in patients with unresectable MAGE-A3-positive metastatic cutaneous melanoma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00942162 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Antigen-Specific Cancer Immunotherapeutic Study Indication: Melanoma

Eligibility Liver Transplantation NCT01139203

- 30.06.20 - 1 Formular, 2 Itemgruppen, 14 Datenelemente, 1 Sprache

Itemgruppen: Inclusion Criteria, Exclusion Criteria

Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation; ODM derived from: https://clinicaltrials.gov/show/NCT01139203

Measurement Instrument Database for the Social Science (MIDSS) - Operating Theatre Human Factors Questionnaire

- 10.06.20 - 1 Formular, 3 Itemgruppen, 39 Datenelemente, 1 Sprache

Itemgruppen: Attitude Items, Knowledge Questions, BACKGROUND INFORMATION

O'Connor, P., Keogh, I., & Ryan, S. (in press). A comparison of the teamwork attitudes and knowledge of Irish surgeons and U.S. Naval aviators. Surgeon. http://www.sciencedirect.com/science/article/pii/S1479666X11001247. Measurement Instrument Database for the Social Science. Retrieved 30.03.2020, from www.midss.ie Primary use / Purpose: To allow an assessment of the attitudes and knowledge of surgeons to various aspects of human factors and teamworking Background: The Operating Theatre human factors questionnaire is based upon the Naval Aviator Human Factors Questionnaire and a human factors knowledge questionnaire designed for U.S Naval aviation (also listed in MIDSS). The questionnaire consists of 23 attitude items, and eight knowledge questions. The attitude items are divided into four scales: 'my stress’ (the consideration of, and possible compensation for, stressors in oneself), ‘stress of others’ (the consideration of, and possible compensation for, stressors in other team members), ‘communication ‘(encompasses communication of intent and plans, delegation of tasks and assignment of responsibilities, and the monitoring of team members), and ‘command responsibility’ (appropriate leadership and its implications for the delegation of tasks and responsibilities. Three further attitude items were included that to obtain information on whether junior personnel were afraid to speak up to more senior personnel, and whether adequate pre- and post-operative team briefs were conducted (the latter two questions were only asked of the surgeons). The eight item multiple-choice knowledge test was developed to address teamwork issues that have been identified as causal to accidents in aviation (situation awareness, decision making, communication, stress, and fatigue). However, as described in the introduction, these teamwork issues also contribute to poor performance and sentinel events in a surgical environments. As the questionnaire was initially developed for use with naval aviators, two surgeons checked, and where necessary adapted, the language so that it was not aviation specific (e.g. aircrew was changed to team member). Psychometrics: The internal consistency of the attitude survey subscales was found to be comparable to that of questionnaires of this type (the Cronbach’s alpha scores for the surgeon sample ranged from 0.41 to 0.66).

Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055 - Screen - Medical / surgical procedures; Risk Factors; Vital Signs; History of Tobacco Use; Alcohol intake

- 10.01.20 - 1 Formular, 10 Itemgruppen, 31 Datenelemente, 1 Sprache

Itemgruppen: Medical/ surgical procedures - Right Eye, Medical/ surgical procedures - Left Eye , Other ocular surgeries and procedures, Risk Factors, Vital Signs, First sitting BP reading, Second sitting BP reading , Third sitting BP reading , History of Tobacco Use, Alcohol intake

Study ID: 110852 Clinical Study ID: 110852 Study Title: MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01134055 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib eye drops, ranibizumab intravitreal injection, placebo Trade Name: pazopanib, ranibizumab Study Indication: Macular Degeneration

Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961 - Autopsy Form

- 25.10.19 - 1 Formular, 3 Itemgruppen, 32 Datenelemente, 1 Sprache

Itemgruppen: Administrative documentation, Autopsy, Investigator's signature

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 is to be filled in if an autopsy has been performed.

Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961 - Suspected Pulmonary Embolism Adjudication

- 17.10.19 - 1 Formular, 11 Itemgruppen, 32 Datenelemente, 1 Sprache

Itemgruppen: Administrative documentation, Suspected PE Adjudication, V/Q Scan Adjudication Result, Spiral CT scan Adjudication Result, Pulmonary Angiogram Adjudication Result, Compression Ultrasonography Adjudication Result, Other test Adjudication Result, Venogram Adjudication Result, Venogram Adjudication Results, Classification Adjudication Result, Adjudicators

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 the adjudication of any suspected Pulmonary Embolism (PE), information on which is recorded in a seperate form.

Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961 - Bleeding Adjudication

- 17.10.19 - 1 Formular, 6 Itemgruppen, 25 Datenelemente, 1 Sprache

Itemgruppen: Administrative documentation, Bleeding Event Adjudication, Adverse event reference numbers, Bleeding Criteria, Classification Adjudication Result, Adjudicators

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 the adjudication of any bleeding event, information on which is recorded in a seperate form.

Fondaparinux in Addition to Intermittent Pneumatic Compression in Abdominal Surgery Patients at VTE Risk - NCT00038961 - Adverse Event

- 17.10.19 - 1 Formular, 11 Itemgruppen, 34 Datenelemente, 1 Sprache

Itemgruppen: Administrative documentation, Initial AE form number, Adverse Event Diagnosis, AE Start Date/Time, AE Intensity, Relationship to Study Drug, Action Taken with Study Drug, Corrective Treatment/Therapy, AE outcome, Seriousness Criteria, Investigator & Monitor

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 (non-serious) adverse events, and is to be filled in as necessary during the study. An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceuticalproduct and which does not necessarily have to have a causal relationship with this treatment. An Adverse Event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratoryfinding, for example), symptoms, or disease temporally associated with the use of a medicinal product, whetheror not considered related to the medicinal product. For a given AE, if certain information (outcome, intensity etc.) is not known at the time of the initial completionof the form, this information will be completed as soon as it is known on the same form.

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