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Oral Topotecan as Radiosensitizing Agent in Patients with Rectal Cancer; NCT00158886 - Study Conclusion

- 2019-08-20 - 1 Formulär, 3 Item-grupper, 10 Dataelement, 1 Språk

Item-grupper: Administrative documentation, Clinical Trials, Conclusion, Investigator Signature

Study ID: 104864/517 Clinical Study ID: 104864/517 Study Title: A Phase I Study of Oral Topotecan as a Radiosensitizing Agent in Patients With Rectal Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158886 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Topotecan + Radiation therapy Trade Name: N/A Study Indication: Rectal Cancer, Carcinoma, Renal Cell

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

- 2017-11-20 - 1 Formulär, 3 Item-grupper, 15 Dataelement, 1 Språk

Item-grupper: Administrative Documentation, End of study, 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 Studienende Bitte füllen Sie diesen Bogen nur bei Studienende aus! Bitte faxen Sie diese Seite umgehend an die Studienzentrale Charité: 030 – 450 7 522 214 Hinweis: Ab dem oben angegebenen Datum ist keine weitere Dokumentation mehr erforderlich.

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

- 2017-11-20 - 1 Formulär, 4 Item-grupper, 11 Dataelement, 1 Språk

Item-grupper: Administrative Documentation, Study withdrawal, Study withdrawal, 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 Bitte füllen Sie diesen Bogen nur bei Abbruch der Studientherapie aus! HINWEIS: Die Dokumentation wird weitergeführt , außer bei Rücknahme der Einwilligung. Dies ist erforderlich für die Intent to Treat Analyse. Bitte faxen Sie diese Seite umgehend an das Studienzentrale der Charité: 030 – 450 7 522 214

End of Study SirTac NCT02936388 - End of Study

- 2017-12-03 - 1 Formulär, 1 Item-grupp, 16 Dataelement, 1 Språk

Item-grupp: 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.

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Logs and Repeats

- 2021-09-27 - 1 Formulär, 4 Item-grupper, 16 Dataelement, 1 Språk

Item-grupper: Administrative Data, Date of visit/assessment, AE/Concomitant medication/Repeat an assessment check question, Liver event

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Logs and Repeats form.

Pharmacokinetics of an oral contraceptive co-administered with Albiglutide in women - 107032 - Various Adverse Events: Hypoglycemia, Injection Site Reaction, Pancreatitis, Thyroid Nodes

- 2019-01-02 - 1 Formulär, 37 Item-grupper, 183 Dataelement, 1 Språk

Item-grupper: Administrative data, (Serious) Hypoglycaemic Events, Serious Adverse Events, Injection Site Reaction, Pancreatitis, Symptoms of Gastrointestinal Illness Associated with Pancreatitis, Pain in the Epigastrium, Pain in the Periumbical Region, Pain in the Right Upper Quadrant, Pain in the Left Upper Quadrant, Pain in the Left Lower Quadrant, Pain in the Right Lower Quadrant, Pain in the Right Flank, Pain in the Left Flank, Pain in the Back, Other Symptoms, Nausea, Vomiting, Fever, Biochemistry, Alkaline phosphatase, Total bilirubin, Direct bilirubin, Creatinine, Other lab test, Diagnostic Studies - Pancreatitis, Abdominal CT Scan, MRI, New Thyroid Nodules, Bidimensional Measurement, Thyroid Nodules AE Details, Thyroid function tests, Free T4, T4, TSH, Free T3, T3 Uptake

Study ID: 107032 Clinical Study ID: GLP107032 Study Title: An open-label study to evaluate the pharmacokinetics of an oral contraceptive containing Norethindrone and Ethinyl Estradiol when co-administered with GSK716155 in healthy adult female subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01077505 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: albiglutide Trade Name: Tanzeum,Eperzan Study Indication: Diabetes Mellitus, Type 2

Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454 - Study Conclusion, Liver Event Check, Status of Treatment Blind, Pregnancy Information, Comment Log

- 2018-06-27 - 1 Formulär, 7 Item-grupper, 19 Dataelement, 1 Språk

Item-grupper: Administrative Data, Liver Events Assessment, Status of Treatment Blind, Pregnancy Information, Study Conclusion, Investigator Comment Log, Investigator's signature

This ODM file contains Study Conclusion, Liver Event Check, Status of Treatment Blind, Pregnancy Information, Comment Log and Signature. To be filled if study concluded or withdrawal from study for any reason. Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.

End of study EpimiRNA Study D Vagal Nerve Stimulation NCT02359188

- 2017-12-19 - 1 Formulär, 1 Item-grupp, 9 Dataelement, 1 Språk

Item-grupp: End of study

NCT02359188 Influence of Transcutaneous Vagal Nerve Stimulation on Expression of microRNA, Cytokines, Chemokines and Neuropeptides as Well as Cerebral Resting State and Gastric Motility Quellenangabe: Dr. Sebastian Bauer Philipps-Universität Marburg

WTZ-GIST-09-01 (Imatinib + LBH589) End of study report 2009-011417-24 DRKS00000657 - WTZ-GIST-09-01 (Imatinib + LBH589) End of study report 2009-011417-24

- 2016-12-02 - 1 Formulär, 3 Item-grupper, 10 Dataelement, 1 Språk

Item-grupper: End of study report, Premature end of study, Date

Phase I study of panobinostat and imatinib in patients with treatment-refractory metastatic gastrointestinal stromal tumors WTZ-GIST-09-01 (EudraCT number: 2009-011417-24; German Clinical Trials Register: DRKS00000657) was approved by the institutional ethics committees of the two participating centers and the German Federal Regulatory Drug Agency (BfArM; 4035954).

SB-681323 in ALI/ARDS risk patients - NCT00996840 - Logs and Repeats

- 2021-09-17 - 1 Formulär, 3 Item-grupper, 16 Dataelement, 1 Språk

Item-grupper: Administrative Data, Adverse Event/Concomitant Medication/Repeat Assessment, Liver Event

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 is to be filled in at the end of the study (regular follow-up or study discontinuation) and lists whether any repeated/additional investigations were performed and/or whether certain events occured in the participant, such as (Non-)Serious Adverse Events. Details about the investigations/events are recorded in different forms.

Effect of inhaled fluticasone furoate/Vilanterol combination on electrocardiographic parameters in healthy subjects, NCT01209026 - Logs and repeat

- 2021-09-27 - 1 Formulär, 3 Item-grupper, 15 Dataelement, 1 Språk

Item-grupper: Administrative data, Adverse event/Concomitant medication/unscheduled assessment check questions, Liver event

Study ID: 102936 Clinical Study ID: HZA102936 Study Title:A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01209026 https://clinicaltrials.gov/ct2/show/NCT01209026?term=NCT01209026 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Allermist,Veramyst,Avamys; Veramyst,Avamys,Allermist Study Indication: Asthma The study consists of a screening, 8 treatment periods and a follow up. Treatment periods 1-4 are each 7 days long. Treatment period 1 Days 1-6 (TP1D-D6) Treatment period 1 Day 7 (TP1D7) Treatment period 2 Days 1-6 (TP2D1-D6) Treatment period 2 Day 7 (TP2D7) Treatment period 3 Days 1-6 (TP3D1-D6) Treatment period 3 Day 7 (TP3D7) Treatment period 4 Days 1-6 (TP4D1-D6) Treatment period 4 Day 7 (TP4D7) This document contains logs and repeat. It has to be filled in for the end of study.

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Treatment Blind, Study conclusion, Pregnancy information

- 2020-02-24 - 1 Formulär, 5 Item-grupper, 17 Dataelement, 1 Språk

Item-grupper: Administrative data, Status of treatment Blind, Study conclusion, Pregnancy information (female), Pregnancy information (male)

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Status of treatment Blind, the Study conclusion and the Pregnancy information form. It has to be filled in for follow-up.

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