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NCT ID: NCT01777295 Completed - Hepatitis B Clinical Trials

Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System

Start date: February 25, 2013
Phase: Phase 2
Study type: Interventional

This study aims to develop innovative immunological read-outs and new technologies in order to further characterise the early immune response and its kinetics as well as the adaptive immune responses to adjuvanted vaccines. This study will also evaluate the reactogenicity in healthy, hepatitis B virus naive adults vaccinated with the hepatitis B surface antigen in combination with a GSK Biologicals' Adjuvant System.

NCT ID: NCT01777126 Completed - Post Cystostomy Clinical Trials

Oral Nutrition After Regular Radical Cystectomy

ONP
Start date: January 2009
Phase: Phase 4
Study type: Interventional

After radical cystectomy, postoperative ileus (POI) is a common complication resulting in a delayed oral nutritional intake with prolonged recovery and hospital stay. However, it is questionable if nutritional support by routine use of parenteral nutrition (PN) is justifiable. A non-randomized before-after trial was conducted. Patients treated with an elective regular radical cystectomy and without preoperative contra-indications for enteral nutrition were eligible. In the control group, PN was initiated immediately after the procedure and continued until resumption of diet. In the interventional group, an ONP was implemented. PN could be initiated if oral intake was still insufficient after five days. The primary end point was the postoperative length of stay.

NCT ID: NCT01776619 Completed - Healthy Clinical Trials

Safety and Tolerability Study of Multiple Doses of PF-06305591

Start date: April 2013
Phase: Phase 1
Study type: Interventional

Safety, tolerability and PK of repeated doses of PF-06305591 will be evaluated in young healthy volunteers toghether with food effect on relative bioavailability of solid formulation after single dose.

NCT ID: NCT01776424 Completed - Clinical trials for Prevention & Control

Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease

COMPASS
Start date: February 28, 2013
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are: - To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD); - To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.

NCT ID: NCT01775761 Completed - TTR Cardiomyopathy Clinical Trials

A Study To Determine Any Effect Of Tafamidis On Electrocardiographic Intervals, Specifically The Rate Corrected QT Interval (QTc)

Start date: January 2013
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the effects of tafamidis on the intervals of the electrocardiogram, specifically the rate corrected QT interval (QTc) in healthy volunteers.

NCT ID: NCT01775618 Completed - Hemophilia A Clinical Trials

Safety and Efficacy of BAY94-9027 in Previously Treated Male Children With Haemophilia A

Start date: May 29, 2013
Phase: Phase 3
Study type: Interventional

Hemophilia A is an inherited blood disorder in which one protein, Factor VIII, needed to form blood clots is missing or not present in sufficient levels. Hemophilia A causes the clotting process to be slowed and the person experiences bleeds causing serious problems that could lead to disability. The current standard treatment for severe hemophilia A is infusion of FVIII to stop bleeding, or regular scheduled treatment to prevent bleeds from occuring. Due to the short half-life of FVIII, prophylaxis may require treatment as often as every other day. In this trial safety and efficacy of a long-acting recombinant Factor VIII molecule is being evaluated in 50 male subjects, < 12 years of age, with severe Hemophilia A. These subjects will receive open label treatment with long-acting rFVIII for approximately 6 months (or longer until 50 exposure days) on a regular schedule at least once every 7-days. Doses and dose intervals may be adapted to the subject's clinical need. A second group of patients will receive open label treatment with the same drug for 12 weeks on a regular schedule of 2x/week. Patients will attend the treatment center for routine blood samples and will be required to keep an electronic diary. Subjects will be offered participation in an optional extension study to collect observations for at least an additional 50 exposure days.

NCT ID: NCT01774786 Completed - Gastric Cancer Clinical Trials

A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer

JACOB
Start date: June 10, 2013
Phase: Phase 3
Study type: Interventional

This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks (q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram [mg/kg] intravenously [IV] followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will continue to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.

NCT ID: NCT01774474 Completed - Diabetes Mellitus Clinical Trials

PRevention of Macular EDema After Cataract Surgery

PREMED
Start date: July 10, 2013
Phase: Phase 3
Study type: Interventional

Cystoid macular edema (CME) is a common cause of vision loss after cataract surgery. In the last few years, several new treatments have been tried to address the problem of CME after cataract surgery in diabetic and non-diabetic patients. The investigators will perform a large RCT with the aim to provide more definite evidence-based recommendations for clinical guidelines to prevent the occurrence of CME after cataract surgery in patients with and without diabetes mellitus (DM).

NCT ID: NCT01774344 Completed - Clinical trials for Carcinoma, Hepatocellular

Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma

RESORCE
Start date: May 14, 2013
Phase: Phase 3
Study type: Interventional

The objective of this study was to evaluate efficacy and safety of regorafenib in patients with advanced liver cancer who had progressed after sorafenib treatment. Patients were treated with regorafenib or placebo using a 2:1 randomization scheme.

NCT ID: NCT01774019 Completed - Clinical trials for Pancreatic Carcinoma

Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

Start date: February 20, 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary cancer.