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NCT ID: NCT01641016 Active, not recruiting - HIV Clinical Trials

BREATHER (PENTA 16) Short-Cycle Therapy (SCT) (5 Days on/2 Days Off) in Young People With Chronic HIV-infection

BREATHER
Start date: April 2011
Phase: Phase 2/Phase 3
Study type: Interventional

The overall aim of the BREATHER trial is to evaluate the role of Short-Cycle Therapy (SCT) in the management of HIV-infected young people who have responded well to antiretroviral therapy (ART) and to determine whether young people with chronic HIV infection undergoing Short-Cycle Therapy of five days on ART and two days off maintain the same level of viral load suppression as those on continuous therapy, over 48 weeks. To assess the advantages and disadvantages of the strategy, the incidence of toxicities, immunological control, resistance mutations, acceptability, quality of life and adherence to the randomised strategy will also be compared. Importantly, because of insufficient data on short-term viral load rebound after stopping ART in this population, the trial will incorporate an initial pilot phase in selected centres, to assess the safety of the SCT strategy by evaluating detailed HIV-1 RNA profiles of participants on the SCT strategy.

NCT ID: NCT01635452 Active, not recruiting - Uterine Fibroids Clinical Trials

A Prospective Multicenter Non-interventional Study of Women Treated With ESMYA (Ulipristal Acetate) as Pre-operative Treatment of Moderate to Severe Symptoms of Uterine Fibroids

PREMYA
Start date: May 2012
Phase: N/A
Study type: Observational

This is a multi-center, prospective, non-interventional study of patients who have been diagnosed with moderate to severe symptoms of uterine fibroids and are initiating a pre-operative treatment with ESMYA. The objectives of the study are to characterize and describe treatment with ESMYA and to evaluate the safety, effectiveness, and HRQL outcomes in this population

NCT ID: NCT01630031 Active, not recruiting - Clinical trials for Paroxysmal Atrial Fibrillation

Contact Force Sensing and Pulmonary Vein Isolation

Start date: November 2010
Phase: N/A
Study type: Observational

Introduction - Pulmonary vein isolation (PVI) is the cornerstone of paroxysmal atrial fibrillation (AF) ablation. Recurrences remain, however, not infrequent and are mainly due to PVs reconnection. In this setting, all procedural means able to improve the quality of tissue lesions are welcome. Study Hypothesis - A continuous sensing of contact force (CF) during ablation, offered by a new catheter available on the market, was a valuable additional tool increasing the efficacy of the ablation procedure for PVI. Methods - Prospective observational non-randomized monocentric study. Patients with paroxysmal AF receive PVI following standard ablation procedures (linear antral catheter ablation guided by CARTO 3 System, Biosense Webster, Inc.) using either a new irrigated RF ablation catheter that provides tip-to-tissue CF information (THERMOCOOL SMARTTOUCH Catheter, Biosense Webster, Inc.) (CF group), or a non-CF irrigated catheter (THERMOCOOL SF or EZ STEER THERMOCOOL Catheter, Biosense Webster, Inc.) (control group). Overall, 60 consecutive patients are enrolled in the study, with 30 patients in each group. All procedures is performed by the same experienced operator, not blinded to the catheter used. Except for CF information (with an objective of at least 10 g, associated to the most perpendicular vector obtainable), ablation procedures are carried out using identical approaches in both groups. Patients are discharged from hospital free of antiarrhythmic therapy. Patients are enrolled in a specific follow-up plan. Primary Endpoints -(1) Proportion of PVI after exclusive anatomic approach, (2) Proportion of patients free of AF after 12-month follow-up.

NCT ID: NCT01615029 Active, not recruiting - Multiple Myeloma Clinical Trials

Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma

Start date: June 26, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to establish the safety profile of daratumumab when given in combination with Lenalidomide and dexamethasone in participants with relapsed or relapsed and refractory Multiple Myeloma (MM).

NCT ID: NCT01608074 Active, not recruiting - BRCA1 Mutation Clinical Trials

Radical Fimbriectomy for Young BRCA Mutation Carriers

Fimbriectomy
Start date: December 2011
Phase: N/A
Study type: Interventional

Some BRCA-mutated women are reluctant to undergo laparoscopic bilateral salpingo-oophorectomy. The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion.

NCT ID: NCT01607047 Active, not recruiting - Leptospirosis Clinical Trials

French West Indies Leptospirosis Study

LEPTO
Start date: December 2010
Phase:
Study type: Observational

Leptospirosis is a zoonosis of worldwide distribution whose incidence is higher in the tropics, where conditions for transmissions are favorable. The disease is endemic in Martinique and Guadeloupe, two Caribbean islands of the French West Indies. In tropical areas, many wild and domestic animals serve as reservoirs for pathogenic Leptospira strains and contaminate the environment by shedding the organisms in their urine. Humans are usually infected through abraded skin or mucous membrane contact with water contaminated by the urine of animal reservoirs, and less frequently by direct contact with animals or their urine. The mean incubation period is 10 days, with a usual range of 2-20 days. Clinical manifestations are protean and the spectrum of symptoms range from subclinical or mild anicteric febrile illness to acute renal failure and respiratory distress syndrome which are associated with high mortality rates. The microscopic agglutination test (MAT) and culture are the reference standard test for diagnosis of leptospirosis, but they are only available in reference laboratories and their conclusive results requires convalescent sample or prolonged incubation. At present, only direct detection methods using PCR might provide rapid diagnosis during the early acute stage of the illness, when treatment is likely to have the greatest benefit. Quantitative PCR also offers the ability to measure level of leptospiremia in clinical samples. Using qPCR based diagnosis, the investigators have the opportunity to study the association of level of leptospiremia and clinical manifestations in French West Indies. All qPCR-positive samples will be used for molecular typing.

NCT ID: NCT01595984 Active, not recruiting - Kidney Failure Clinical Trials

Comparison of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI)Versus a CNI-free Treatment in Renal Transplantation (CIME)

CIME
Start date: May 3, 2012
Phase: Phase 3
Study type: Interventional

The main objective of this protocol is to compare the impact on renal function of two different immunosuppressive regimens in patients with de novo renal transplant. Renal function will be accurately evaluated by measuring the clearance of iohexol. The protocol will also evaluate the efficacy and safety in a short term of these two different immunosuppressive regimens.

NCT ID: NCT01594723 Active, not recruiting - Clinical trials for Neoplasms, Hematologic

A Study of LY2784544 in Participants With Myeloproliferative Neoplasms

Start date: May 22, 2012
Phase: Phase 2
Study type: Interventional

The primary purpose of this study is to measure the response rate in participants with the myeloproliferative neoplasms (MPNs), polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF) when treated with LY2784544, including those who have demonstrated an intolerance to, failure of primary response to, or have demonstrated disease progression while on ruxolitinib.

NCT ID: NCT01594463 Active, not recruiting - Clinical trials for Fetal Growth Retardation

Routine Ultrasound Screening in the Third Trimester

RECRET
Start date: May 2012
Phase: N/A
Study type: Interventional

Late intrauterine growth restriction is infrequently diagnosed with an overall sensitivity of 40 % in low-risk pregnancies. In addition, late intrauterine growth restriction may be associated with intrauterine death and poor neonatal outcomes i.e. birth asphyxia and hospitalization in intensive care unit. The investigators hypothesis that a later third trimester routine ultrasound may be more accurate to diagnose late intrauterine growth restriction.

NCT ID: NCT01592370 Active, not recruiting - Multiple Myeloma Clinical Trials

An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma

Start date: August 2, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the side effects of treatment of the combination of nivolumab and daratumumab in participants with relapsed/refractory multiple myeloma.