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NCT ID: NCT01625026 Completed - Obesity Clinical Trials

Obeticholic Acid in Bariatric and Gallstone Disease

OCABSGS
Start date: September 2013
Phase: Phase 2
Study type: Interventional

By binding to the nuclear receptor FXR, bile acids not only regulate their own turn-over but presumably also pivotal steps in cholesterol, triglyceride and glucose metabolism as shown in laboratory animals. Obeticholic acid (OCA) is a semisynthetic bile acid with very high affinity to FXR. In a pharmacodynamic study the effects of OCA on bile acid, lipid and glucose turn-over are studied in 20 morbidly obese and 20 gallstones patents, respectively, that are administered OCA at 25 mg/day in three weeks before bariatric (BS) or gallstone (GS) surgery where in addition to blood samples also biopsies are taken from the liver and in the case of BS, omental and subcutaneous adipose tissue and in case of GS, gallbladder bile.

NCT ID: NCT01623115 Completed - Clinical trials for Hypercholesterolemia

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

ODYSSEY FH I
Start date: July 2012
Phase: Phase 3
Study type: Interventional

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. Secondary Objectives: - To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points - To evaluate the effects of alirocumab on other lipid parameters - To evaluate the safety and tolerability of alirocumab

NCT ID: NCT01622439 Completed - Clinical trials for Diffuse Large B-cell Lymphoma

Valproate as First Line Therapy in Combination With Rituximab and CHOP in Diffuse Large B-cell Lymphoma

VALFRID
Start date: June 2012
Phase: Phase 1/Phase 2
Study type: Interventional

Patients with previously untreated diffuse large B-cell lymphoma will receive standard treatment with R-CHOP (rituximab,cyclosphosphamide, doxorubicin, vincristine, and prednison) for 6 cycles, cycle length is 14 or 21 days. In addition, valproate is given three times daily day 1-3 in escalated doses. The rationale for adding valproate to standard treatment is invitro data indicating a sensitizing effect to chemotherapy, and an increase in CD 20-expression. Patients are included in 3+3 cohorts with escalation of valproate dose, planned dos levels are 30, 60, 80, 100, 120, 140 mg/kg/day. A total of 20 patients will be treated at the MTD.

NCT ID: NCT01621217 Completed - Clinical trials for Locally Advanced Cancer in the Anal Region

Phase I Study of Cetuximab in Combination With 5-fluoruracil, Mitomycin C and Radiotherapy in Patients With Anal Cancer Stage T2 (>4 cm) - T4 N0-3 M0 or Any T N2-3 M0

NOAC8
Start date: June 2012
Phase: Phase 1
Study type: Interventional

- To establish maximum tolerated dose of the two cytotoxic drugs 5-fluoruracil and mitomycin C when given together with the antibody cetuximab in patients with locally advanced cancer in the anal region - To evaluate acute toxicity - To evaluate late toxicity - To evaluate response rate - To evaluate recurrence free survival - To evaluate overall survival

NCT ID: NCT01620125 Completed - Type 2 Diabetes Clinical Trials

Metabolic Control Before and After Supplementation With Lactobacillus Reuteri DSM 17938 in Type 2 Diabetes Patients

Start date: May 2012
Phase: Early Phase 1
Study type: Interventional

Recent data suggest that the trillions of bacteria in the investigators gastrointestinal tracts (gut microbiota) can function as an environmental factor that modulates the amount of body fat. Obese individuals have an altered gut microbiota and germ-free mice are resistant to developing diet-induced obesity and have lower fasting insulin and glucose and improved glucose tolerance. Administration of the probiotic bacterium Lactobacillus strain in fermented milk for 12 weeks reduced adiposity and body weight in obese adults, possibly by reducing lipid absorption and inflammatory status. However, there are no studies to the investigators knowledge that address whether probiotic supplementation improves glucose metabolism in type 2 diabetes patients.

NCT ID: NCT01619423 Completed - Clinical trials for Advanced Metastatic (Stage IV) Colorectal Cancer

A Trial of PledOx + FOLFOX6 Compared to Placebo + FOLFOX6 in Patients With Metastatic Colorectal Cancer

PLIANT
Start date: September 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The present trial is designed to determine whether pre-treatment with PledOx lowers the frequency and severity of side effects from FOLFOX6 administration in patients with metastatic colorectal cancer. The efficacy of PledOx will be assessed when added to FOLFOX6 chemotherapy as first line treatment of metastatic colorectal cancer. This study was performed in multiple parts/phases. Part 1 was an open dose-escalation study with the doses 2, 5 and 10 micromol/kg of calmangafodipir. No study outcomes were planned for this part. In part 2a, participants randomly received either Placebo, 2 or 10 micromol/kg of calmangafodipir. In part 2b, participants randomly received either Placebo, 2 or 5 micromol/kg of calmangafodipir. The overall intent of the study was to compare the effect of antioxidant agent PledOx against placebo in one of three different doses/combinations (2 micromol/kg, 5/10 micromol/kg, 2/5/10 micromol/kg vs. placebo, in the first 8 cycles of FOLFOX6 treatment

NCT ID: NCT01619007 Completed - Clinical trials for Deep Vein Thrombosis

Treatment of an Acute Deep Vein Thrombosis (DVT) With Either Rivaroxaban or Current Standard of Care Therapy

XALIA
Start date: June 2012
Phase: N/A
Study type: Observational

Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute deep vein thrombosis (DVT). The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT in routine clinical practice.

NCT ID: NCT01618370 Completed - Prostatic Neoplasms Clinical Trials

Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

Start date: July 22, 2012
Phase: Phase 3
Study type: Interventional

This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product.

NCT ID: NCT01617967 Completed - Clinical trials for TTR-mediated Amyloidosis

Safety and Tolerability of Patisiran (ALN-TTR02) in Transthyretin (TTR) Amyloidosis

Start date: May 2012
Phase: Phase 2
Study type: Interventional

This was a multiple dose, dose escalation study designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of patisiran (ALN-TTR02) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).

NCT ID: NCT01617837 Completed - Clinical trials for Postoperative Nausea and Vomiting

The Efficacy of P6 Acupressure in Reducing Postoperative Nausea and Vomiting in Patients Undergoing Craniotomy

Start date: November 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to investigate if P6 acupressure may reduce postoperative nausea and vomiting in neurosurgical patients undergoing craniotomy.