Suchergebnisse - Portal für Medizinische Datenmodelle (MDM-Portal)

Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC) - Zytoreduktive Chirurgie / HIPEC Part 1

- 27.09.21 - 1 Formular, 6 Itemgruppen, 75 Datenelemente, 1 Sprache

Itemgruppen: Administrative Documentation, Physical Examination, Laboratory Data, Cytoreductive Surgery, Peritoneal Cancer Index, Type of surgery

Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction NCT-Identifier: NCT02158988 Source: Prof. Dr. med. Beate Rau, MBA Charité Universitätsmedizin Berlin Woche 12

SB-681323 in ALI/ARDS risk patients - NCT00996840 - Local Laboratory - Clinical Chemistry and Haematology

- 16.07.19 - 1 Formular, 3 Itemgruppen, 13 Datenelemente, 1 Sprache

Itemgruppen: Laboratory Administrative Data, Clinical Chemistry Analysis, Haematology Lab Analysis

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 includes Clinical Chemistry and Haematology lab examinations and results and is to be filled in at Screening, on Days 2 and 3 at 0 hrs and Day 3 at 24 hrs (i.e. Day 4 - 0 hrs) and at Follow-Up for all cohorts and for any repeat analyses.

Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC) - Weitere Follow up

- 20.11.17 - 1 Formular, 12 Itemgruppen, 40 Datenelemente, 2 Sprachen

Itemgruppen: Administrative Documentation, Physical Examination, Laboratory Data, Diagnostic procedures, Results, Concomitant therapy, Toxicities, Late toxicites, Progress, Adverse Event, Life quality, Administrative Documentation

Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction NCT-Identifier: NCT02158988 Source: Prof. Dr. med. Beate Rau, MBA Charité Universitätsmedizin Berlin Weitere Follow up (ab Monat 12 bis Studienende)

Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC) - 1. Follow up

- 20.11.17 - 1 Formular, 9 Itemgruppen, 59 Datenelemente, 1 Sprache

Itemgruppen: Administrative Documentation, Physical Examination, Laboratory Data, Diagnostic procedures, Results, Progress, Concomitant therapy, Adverse Event, Administrative Documentation

Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction NCT-Identifier: NCT02158988 Source: Prof. Dr. med. Beate Rau, MBA Charité Universitätsmedizin Berlin 1. Follow up (Monat 9)

Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC) - Visit 11 - Therapieende

- 20.11.17 - 1 Formular, 7 Itemgruppen, 53 Datenelemente, 1 Sprache

Itemgruppen: Administrative Documentation, Physical Examination, Laboratory Data, Diagnostic procedures, Results, Progress, Administrative Documentation

Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction NCT-Identifier: NCT02158988 Source: Prof. Dr. med. Beate Rau, MBA Charité Universitätsmedizin Berlin Visit 11 - Therapieende (Woche 28) Toxizitäten / Unerwünschte Ereignisse / Hospitalisierungen werden im 1. Follow up dokumentiert. Das 1. Follow-up findet 3 Monate nach der letzten Chemotherapie statt.

Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC) - Visit 8

- 20.11.17 - 1 Formular, 10 Itemgruppen, 71 Datenelemente, 1 Sprache

Itemgruppen: Administrative Documentation, Adverse Event, Physical Examination, Laboratory Data, Disease Progression, Diagnostic procedures, Postoperative Chemotherapy, Capecitabine, Life quality, Administrative Documentation

Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction NCT-Identifier: NCT02158988 Source: Prof. Dr. med. Beate Rau, MBA Charité Universitätsmedizin Berlin Visit 8 - Chemotherapie-Zyklus 4 (Woche 19)

Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC) - Visit 10

- 20.11.17 - 1 Formular, 9 Itemgruppen, 65 Datenelemente, 1 Sprache

Itemgruppen: Administrative Documentation, Physical Examination, Laboratory Data, Disease Progression, Additive Chemotherapy, Capecitabine, Life quality, Adverse Event, Administrative Documentation

Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction NCT-Identifier: NCT02158988 Source: Prof. Dr. med. Beate Rau, MBA Charité Universitätsmedizin Berlin Visit 10 - Chemotherapie-Zyklus 6 (Woche 25)

Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC) - Visit 9

- 20.11.17 - 1 Formular, 7 Itemgruppen, 62 Datenelemente, 1 Sprache

Itemgruppen: Administrative Documentation, Physical Examination, Laboratory Data, Additive Chemotherapy, Capecitabine, Adverse Event, Administrative Documentation

Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction NCT-Identifier: NCT02158988 Source: Prof. Dr. med. Beate Rau, MBA Charité Universitätsmedizin Berlin Visit 8 - Chemotherapie-Zyklus 5 (Woche 22)

Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC) - Visit 7 - Entlassung

- 19.11.17 - 1 Formular, 8 Itemgruppen, 58 Datenelemente, 1 Sprache

Itemgruppen: Administrative Documentation, Hospital stay information, Physical Examination, Laboratory Data, Non-surgical Complications, Surgical Complications, Adverse Event, Administrative Documentation

Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction NCT-Identifier: NCT02158988 Source: Prof. Dr. med. Beate Rau, MBA Charité Universitätsmedizin Berlin Visit 7 – Entlassung

Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC) - Visit 4

- 16.11.17 - 1 Formular, 8 Itemgruppen, 57 Datenelemente, 1 Sprache

Itemgruppen: Administrative Documentation, Physical Examination, Laboratory Data, Diagnostic procedures, Results, Disease Progression, Adverse Event, Administrative Documentation

Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction NCT-Identifier: NCT02158988 Source: Prof. Dr. med. Beate Rau, MBA Charité Universitätsmedizin Berlin Visit 4 – Ende Chemotherapie-Zyklus 3 (Woche 9)

Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC) - Visit 3

- 16.11.17 - 1 Formular, 8 Itemgruppen, 64 Datenelemente, 1 Sprache

Itemgruppen: Administrative Documentation, Physical Examination, Laboratory Data, Disease Progression, Preoperative Chemotherapy, Capecitabine, Adverse Event, Administrative Documentation

Prospective Multicenter Phase III Trial Using CRS With / Without HIPEC After Preoperative Chemotherapy in Patients With Peritoneal Carcinomatosis of Gastric Cancer Incl. Adenocarcinoma of the Esophagogastric Junction NCT-Identifier: NCT02158988 Source: Prof. Dr. med. Beate Rau, MBA Charité Universitätsmedizin Berlin Visit 3 – Chemotherapie-Zyklus 3 (Woche 6)

Cytoreductive Surgery (CRS) With/Without HIPEC in Gastric Cancer With Peritoneal Carcinomatosis (GASTRIPEC) - Visit 2