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NCT ID: NCT02921971 Completed - Systemic Sclerosis Clinical Trials

Effectiveness and Safety of SAR156597 in Treating Diffuse Systemic Sclerosis

Start date: December 21, 2016
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate, in comparison with placebo, the efficacy of SAR156597 administered subcutaneously for 24 weeks on skin fibrosis in participants with diffuse cutaneous systemic sclerosis (dcSSc). Secondary Objectives: - To evaluate the efficacy of SAR156597 compared to placebo on physical/functional disability in participants with dcSSc. - To evaluate the efficacy of SAR156597 compared to placebo on respiratory function of participants with dcSSc. - To evaluate the safety profile of SAR156597 compared to placebo in participants with dcSSc. - To evaluate the potential for immunogenicity (anti-drug antibodies response) of SAR156597 in participants with dcSSc. - To evaluate the pharmacokinetics (trough plasma concentrations) of SAR156597 administered subcutaneously for 24 weeks.

NCT ID: NCT02921919 Completed - Cancer Clinical Trials

Open-Label Extension and Safety Study of Talazoparib

Start date: November 8, 2016
Phase: Phase 2
Study type: Interventional

This is a single-arm, open-label, extended treatment, safety study in patients treated with talazoparib in qualifying studies.

NCT ID: NCT02921750 Completed - Venous Leg Ulcer Clinical Trials

Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately or Strongly Exuding Venous and Mixed Ulcers of Predominantly Venous Origin

PD-497314
Start date: October 2016
Phase: N/A
Study type: Interventional

The investigation is designed as an open, randomized, non-inferiority, multi-centre investigation. 212 evaluable subjects will be randomised. Subjects to be included will suffer from an exuding venous or mixed ulcer of predominantly venous origin. Subjects will either be randomized to Exufiber®Gelling Fibre Dressing or Aquacel®Extra Hydrofiber® Dressing with Strengthening Fibre using, centralized randomization

NCT ID: NCT02920723 Completed - Clinical trials for Sleep Apnea Syndromes

Follow-up of the Patients Included in the EXESAS Study

FOLLOW_EXESAS
Start date: September 1, 2016
Phase: N/A
Study type: Interventional

Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It does multiply tenfold the occurrence of vascular events, particularly stroke. While Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term adherence to CPAP is a significant problem and search for alternative treatment is essential.

NCT ID: NCT02920697 Completed - Clinical trials for Multiple Myeloma (MM)

Dose-escalation Study of Oral Administration of S 55746 in Patients With Chronic Lymphocytic Leukaemia and B-Cell Non-Hodgkin Lymphoma

Start date: March 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety profile and tolerability of S 55746 in patients with CLL, B-Cell NHL and MM, in terms of Dose-Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) through safety profile (DLT, MTD), PK profile, PD profile and preliminary efficacy.

NCT ID: NCT02920684 Completed - Sedated Patients Clinical Trials

Haemodynamic and Metabolism Response During Early Rehabilitation in Sedated Patients

Start date: December 2016
Phase: Phase 3
Study type: Interventional

Despite several positive studies, benefits of early rehabilitation on recovery and motor performance improvement need to be demonstrate. A recent study finds that despite early rehabilitation, 1 survivor of 2 (52%) acquired an ICU weakness. The low intensity exercises applied in intensive care is common and most patients stay in bed. Under these conditions, the optimal choice of the rehabilitation technique for bedridden patient and its intensity should be studied. The objective of the study is to evaluate the cardiovascular and metabolic response of patients during four interventions: Passive legs mobilization, Passive cycloergometter, Quadriceps neuromuscular electrical stimulation and Functional electrical stimulation.

NCT ID: NCT02920541 Completed - Clinical trials for Myelodysplastic Syndrome (MDS)

Dose-escalation Study of Oral Administration of S 055746 in Patients With Acute Myeloid Leukaemia or Myelodysplastic Syndrome

Start date: January 2015
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety profile and tolerability of S 055746 in patients with AML, and high or very high risk MDS, in terms of Dose-Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD) and determine the Recommended Phase 2 Dose (RP2D) through safety profile (DLT, MTD), PK profile, PD profile and preliminary efficacy.

NCT ID: NCT02920398 Completed - Clinical trials for Congenital Bleeding Disorder

A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A

pathfinderâ„¢7
Start date: October 4, 2016
Phase: Phase 1
Study type: Interventional

Investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe haemophilia A

NCT ID: NCT02920281 Completed - Sleep Quality Clinical Trials

Impact of Sleep Quality on Respiratory Function and Weaning of Mechanical Ventilation

WEAN SLEEP 1
Start date: November 2014
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the impact of sleep quality on the length of mechanical ventilation weaning, in intensive care unit patients

NCT ID: NCT02920216 Completed - Clinical trials for Head and Neck Cancer

Interest of Fluorescence in Salvage Surgery for Recurrence of Head and Neck Cancer in Irradiated Area

SALVADS-Fluo
Start date: December 6, 2016
Phase: N/A
Study type: Interventional

Treatment of Head and Neck Squamous cell carcinoma often combines chemoradiotherapy when organ has to be preserved or when surgery is not indicated. The loco-regional failure is about 30%. Then salvage surgery is the only chance for patients to survive but the overall survival rate is only 29% at 24 months. This prognostic is bad because of poor local control which is non-optimized by a complementary radiotherapy and negative exeresis margins. Currently, there is no intraoperative technique to better visualize the tumor limits in real time. With fluorescence techniques, an accurate mapping of tumor extension can be considered. Recently, Atallah et al. (2015) demonstrated the use of fluorescence during a head and neck surgery in mice, as a tool allowing for better surgical margins. Digonnet et al (2015) found a tumor fragment after an injection of indocyanine green (ICG) intravenously in salvage surgery for patient with head and neck cancer. The ability of ICG to detect a surgical margin positive intraoperatively has never be evaluated in irradiated area. The aim of this pilot study is to evaluate the interest of fluorescence in salvage surgery for recurrence of head and neck cancer in irradiated area.