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NCT ID: NCT01449370 Completed - Clinical trials for Metastatic Solid Tumors

Dose Escalation Study of MLN1117 in Subjects With Advanced Cancer

Start date: October 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the maximum tolerated dose (MTD) and/or optimal biologic dose(OBD), safety and tolerability, dose-limiting toxicity (DLT) of MLN1117 when administered orally in subjects with advanced solid malignancies.

NCT ID: NCT01449162 Completed - Asthma Clinical Trials

Masitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids

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

The study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids.

NCT ID: NCT01449110 Completed - Clinical trials for Cardiovascular Diseases

Resveratrol-enriched Grape Extract (Stilvid) in Primary and Secondary Prevention of Cardiovascular Disease

FUNGRAPE
Start date: April 2009
Phase: Phase 2
Study type: Interventional

Resveratrol can exhibit benefits against cardiovascular diseases (CVDs) although the cardioprotective role of resveratrol as part of the human diet is not yet clear. The aim of this trial is to evaluate the safety and efficacy of a resveratrol-enriched grape extract (Stilvid) in 150 patients from both primary and secondary cardiovascular prevention. All the patients are gold-standard medicated (statins and others). A number of cardiovascular risk and safety markers will be evaluated after consuming 1 cap/day for 6 months and 2 caps/day for 6 additional months (total 12 months).

NCT ID: NCT01449058 Completed - AML Clinical Trials

A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors

Start date: March 2012
Phase: Phase 1
Study type: Interventional

This is a multi-center, open-label, dose-finding, phase Ib study to estimate the maximum tolerated dose(s) (MTD(s)) and/or recommended dose(s) for expansion (RDE(s)) for the orally administered combination of BYL719 and MEK162. This combination will be explored in adult patients with advanced CRC, esophageal cancer, pancreatic cancer, NSCLC, ovarian cancer, or other advanced solid tumors and in adult patients with AML or high risk and very high risk MDS, with documented RAS or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RDE, four expansion arms will be opened in order to further assess the safety and preliminary activity of the combination of BYL719 and MEK162 in specific patient populations.

NCT ID: NCT01448863 Completed - Obesity Clinical Trials

Metabolomic Embryo Profiles of Obese in Vitro Fertilization (IVF) Patients and Their Relationship With Polycystic Ovary Syndrome (PCO)

Start date: October 2011
Phase: N/A
Study type: Observational

The present study aims to elucidate if there is a metabolomic profile alteration in the embryos of obese women in order to understand if the reduced implantation rate observed in these patients is directly related to this factor. Furthermore, the investigators seek to establish if there is any difference between obese women with Polycystic Ovary Syndrome (PCO) and without PCO. The investigators compare these metabolomic profile embryos with embryos of egg-donation programme.

NCT ID: NCT01448707 Completed - Clinical trials for Human Immunodeficiency Virus (HIV) Infections

A Clinical Trial Comparing the Efficacy of Darunavir/Ritonavir Monotherapy Versus a Triple Combination Therapy Containing Darunavir/Ritonavir and 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Patients With Undetectable Plasma HIV-1 RNA on Current Treatment

PROTEA
Start date: March 15, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy, safety and tolerability of darunavir/ritonavir 800/100 mg monotherapy with a triple combination therapy containing darunavir/ritonavir 800/100 mg and 2 nucleoside/nucleotide reverse transcriptase inhibitors (N[t]RTIs) in approximately 260 Human Immunodeficiency Virus-1 (HIV-1) infected patients who have been on Highly Active AntiRetroviral Therapy (HAART) medication and have a plasma Viral Load below 50 copies/mL for at least 48 weeks. Also the changes in neurocognitive function will be compared throughout the study.

NCT ID: NCT01448044 Completed - Hepatitis C Clinical Trials

Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C

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

The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).

NCT ID: NCT01447550 Completed - Clinical trials for Thromboangiitis Obliterans

Treatment of Thromboangiitis Obliterans (Buerguer's Disease) With Bosentan

Start date: January 2009
Phase: N/A
Study type: Observational

This study assessed the effectiveness and safety of bosentan when administered to thromboangiitis obliterans (Buerger's disease)patients. A clinical pilot study was designed,included in which patients with ulcer and/or pain at rest were treated with bosentan p.o at a dose of 62,5 mg twice daily during the first month, which each thereafter uptitrated to 125 mg twice daily. Study endpoints were clinical improvement rate, major or minor amputation rate, hemodynamic changes, changes in endothelial function and angiographic changes. 12 patients were included were current smokers. With bosentan treatment, no new ischemic lesions were observed in all but one patient. Overall, clinical improvement was observed in 12 of the 13 extremities (92%). Only two of 13 extremities underwent amputation after bosentan treatment. As assessed by digital arteriography with subtraction or angio-magnetic resonance image an increase of distal flow was observed in 10 out of the 12 patients. All patients experienced a statistically significant improvement in their BAFMD values (means:1.8 at baseline;6.6 at the end of the treatment;12.7 three months after the end of the treatment;p<0.01). In conclusion: Bosentan treatment may result in an improvement of clinical, angiographic, hemodynamic and endothelial function outcome. Bosentan deserves further investigation in the management TAO patients.

NCT ID: NCT01447537 Completed - Cirrhosis Clinical Trials

Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis

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

The investigators conducted a pilot study including 17 patients with liver cirrhosis showing that a moderate exercise programme during three months increased thigh circumference,exercise tolerance and quality of life without adverse effects. The present study aim to more accurately evaluate the effect of exercise on muscle mass, effort tolerance and inflammatory response in patients with cirrhosis. This study will include 30 patients with compensated liver cirrhosis that will be randomized into two groups: exercise group and control group. Evaluation of muscle mass, effort tolerance, inflammatory response and quality of life will be made at the beginning and at the end of the study.

NCT ID: NCT01447472 Completed - Metabolism Clinical Trials

-Methylenedioxymethamphetamine (MDMA, Ecstasy) Induced Changes in Drug Metabolism: Gender and Genetic Polymorphisms

Start date: May 2003
Phase: Phase 1
Study type: Interventional

The purpose of this study are: 1. to evaluate the involvement of CYP2D6, CYP3A4 and CYP1A2 (through dextromethorphan and caffeine challenges), and catechol-O-methyltransferase (COMT)in MDMA metabolism 2. to evaluate gender differences in the human pharmacology of MDMA 3. to study the influence of some genetic polymorphisms (CYP2D6, COMT, SERT) in the effects and pharmacokinetics of MDMA.