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NCT ID: NCT01324791 Completed - Clinical trials for Gastroesophageal Reflux Disease

Laparoscopic Antireflux Surgery Versus Endoscopic Full-thickness Gastroplication for Gastroesophageal Reflux Disease (GERD)

Start date: n/a
Phase: N/A
Study type: Interventional

Endoscopic full thickness gastroplication (Plicator-Procedure) has the potential to be a safe and effective alternative to laparoscopic antireflux surgery (LARS)to improve symptoms of GERD. This prospective randomized study compares objective and subjective outcome parameters of Plicator with that of LARS.

NCT ID: NCT01324739 Completed - Diabetes Mellitus Clinical Trials

B-type Natriuretic Peptide and Glucose Metabolism

Start date: May 2010
Phase: N/A
Study type: Interventional

Rationale: B type natriuretic peptide (BNP) is a hormone released from cardiomyocytes in response to myocyte stretching and serves as a reliable biomarker in the diagnosis of cardiac dysfunction and heart failure. Recent observations speak for a distinct connection between chronic heart failure and diabetes mellitus. Objective: The study was set out to investigate the role of BNP on parameters of glucose metabolism in a placebo controlled cross-over study in healthy volunteers. Methods and Results: Ten participants (25±1 years; BMI 23±1 kg/m2; fasting glucose 83±2 mg/dL) received either placebo or 3 pmol/kg/min BNP 32 intravenously for 4h. One hour after beginning the BNP/placebo infusion, a 3h intravenous glucose tolerance test (0.33 g/kg glucose + 0.03 U/kg insulin at 20 min) was performed and plasma glucose, insulin and C peptide were frequently measured. BNP increased the initial glucose distribution volume (13±1 %BW vs. 11±1, P<0.002), leading to an overall reduction of glucose concentration (P<0.001) especially during the initial 20 min of the test (P=0.001), accompanied by a reduction of the initial C peptide levels (4.3±0.4 ng/mL vs. 4.9±0.3, P=0.015). BNP had no impact on beta cell function, insulin clearance or insulin sensitivity. Discussion: Intravenous administration of BNP increases glucose initial distribution volume and lowers plasma glucose concentrations after a glucose load without affecting beta cell function or insulin sensitivity what speaks for the concept that BNP is not diabetogenic, but improves the metabolic status in patients with heart failure. This opens new questions regarding BNP induced differences in glucose availability and signalling in several organs/tissues.

NCT ID: NCT01324349 Completed - Liver Disease Clinical Trials

Comparison of the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery

Start date: February 2011
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and effectiveness of Covidien's Hemostatic Patch to control bleeding during hepatic surgery. The performance of the Hemostatic Patch will be compared to Control as an adjunct to conventional hemostatic techniques.

NCT ID: NCT01324128 Completed - Clinical trials for Chronic Kidney Disease Requiring Chronic Dialysis

A Phase 3 Study to Investigate the Safety and Efficacy of PA21, a Phosphate Binder, in Dialysis Patients

Start date: March 2011
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomised, active controlled, multicentre study to investigate the safety and efficacy of PA21, a phosphate binder, for control of hyperphosphataemia in dialysis patients. The primary objective is to establish the efficacy of PA21 for lowering phosphate levels in these patients.

NCT ID: NCT01324037 Completed - Clinical trials for Suspected Upper Extremity Deep Vein Thrombosis

Diagnostic Algorithm in Suspected Upper Extremity Deep Vein Thrombosis

Armour
Start date: March 2010
Phase: N/A
Study type: Interventional

Deep vein thrombosis (DVT) of the arm, officially called upper extremity DVT is a rare disorder and accounts for up to 1-4% of all cases of deep vein thrombosis. In case of a thrombosis, there is a blood clot in one of the veins, which should be treated with blood thinners (anticoagulants). The aim of the present study is to see whether it is safe to use a combination of tests for the diagnosis of arm thrombosis. In all patients, we will use a clinical decision rule (clinical judgement) and a laboratory test (D-dimer testing), in most patients also an ultrasound of the arm will be done. The combination of these tests was found to be safe and effective in patients with thrombosis of the legs.

NCT ID: NCT01323244 Completed - Hepatitis C Clinical Trials

A Study of TMC435 in Combination With Peginterferon Alfa-2A and Ribavirin for Hepatitis C Virus Genotype-1 Infected Patients Who Participated in a Control Group of a TMC435 Study

Start date: December 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the efficacy of a treatment with TMC435 in combination with peginterferon alfa-2a and ribavirin in patients who did not clear their hepatitis C infection with peginterferon alfa-2a and ribavirin alone within a previous trial conducted by Tibotec, or who participated in Tibotec trials in which antivirals directed against hepatitis C virus (HCV) were evaluated for short periods of time.

NCT ID: NCT01323205 Completed - Schizophrenia Clinical Trials

Investigation of the Safety, Tolerability and Potential Therapeutic Effects of JNJ-40411813 in Patients With Schizophrenia

Start date: May 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to explore the safety, tolerability, and potential clinical efficacy of JNJ 40411813 in schizophrenic patients.

NCT ID: NCT01321554 Completed - Thyroid Cancer Clinical Trials

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC)

SELECT
Start date: March 17, 2011
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to compare the progression free survival, overall response rate (ORR) and safety of participants treated with lenvatinib 24 mg by continuous once daily oral dosing versus placebo. The study is conducted in 3 phases: a Prerandomization Phase (screening and baseline period), a Randomization Phase (double-blind treatment period), and an Extension Phase (Optional Open Label (OOL) Lenvatinib Treatment Period and a follow-up period).

NCT ID: NCT01321541 Completed - Clinical trials for Diffuse Large B-cell Lymphoma

Comparison of Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy and Are Not Eligible for Stem Cell Transplant

PIX-R
Start date: April 20, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), or follicular grade 3 lymphoma.

NCT ID: NCT01321294 Completed - Clinical trials for Gastroesophageal Reflux Disease

Laparoscopic Nissen Versus Toupet Fundoplication: Objective and Subjective Results of a Prospective Randomized Trial

Start date: n/a
Phase: N/A
Study type: Interventional

The aim of this study is to compare subjective and objective outcome and surgical "side effects" of Nissen and Toupet fundoplication performed in a single institution by only two surgeons and to compare pre and postoperative findings to healthy individuals.