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NCT ID: NCT03151317 Completed - Clinical trials for Noninvasive Ventilation

Effects of a Therapeutic Education Program on Treatment Adherence Among Patients Prescribed At-home CPAP or At-home NIV

APARDetp
Start date: May 12, 2017
Phase:
Study type: Observational

The primary objective of this study is to study the effect of therapeutic education on patient adherence for at-home continuous positive airway pressure (CPAP) or at-home non-invasive ventilation. This first study will use data already present in the Association for Home Assistance and Rehabilitation (APARD) database to compare patients who received therapeutic education with a control group who did not.

NCT ID: NCT03150719 Completed - Cystic Fibrosis Clinical Trials

A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF)

Start date: May 24, 2017
Phase: Phase 3
Study type: Interventional

Study VX16-661-114 (Study 114) is a Phase 3b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study in subjects aged 12 years and older with CF who are homozygous for the F508del mutation on the cystic fibrosis transmembrane conductance regulator gene (CFTR) gene and who discontinued treatment with Orkambi due to respiratory symptoms considered related to treatment. This study is designed to evaluate the safety and efficacy of Tezacaftor/Ivacaftor (TEZ/IVA).

NCT ID: NCT03150459 Completed - Cirrhoses, Liver Clinical Trials

Simvastatin Plus Rifaximin in Decompensated Cirrhosis

LIVERHOPE
Start date: July 26, 2017
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to investigate whether the combination of two different drugs, simvastatin and rifaximin, is safe in the treatment of patients with decompensated cirrhosis. The secondary purpose is to see if this combination results in an improvement in inflammation markers in patients with cirrhosis and in an improvement in analytic parameters of progression of liver disease.

NCT ID: NCT03150290 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Brown Adipose Tissue in ALS

BATALS
Start date: October 26, 2017
Phase: N/A
Study type: Interventional

Weight loss is a common phenomenon in ALS. During the course of the disease, difficulty in swallowing and mastication can be responsible for a decrease in caloric intake and thus for weight loss. However, significant weight loss can also be observed in patients with no feeding difficulties. About half of ALS patients have an increase in their resting energy consumption, but the origin of this "hypermetabolism" remains unknown. "Brown" fat is specialized in the production of heat. Unlike "white" fat that stores excess caloric intakes, brown fat consumes energy. In humans, brown fat has long been considered as absent in adults. However, recent imaging techniques have been able to detect brown fat deposits in some adult subjects. The aim of this study is thus to determine the role of brown fat on energy consumption in Amyotrophic Lateral Sclerosis.

NCT ID: NCT03150212 Completed - Clinical trials for Constipation-predominant Irritable Bowel Syndrome

Effect of Saccharomyces Cerevisiae on the Improvement of Gastro-intestinal Disorders Associated to IBS With C Phenotype

IBS-GO
Start date: March 20, 2017
Phase: N/A
Study type: Interventional

The main objective is to assess the effect of an 8-week daily supplementation with IbSium® (probiotic yeast Saccharomyces cerevisiae CNCM I-3856) on the improvement gastro-intestinal disorders associated to the type C IBS (constipation predominant).

NCT ID: NCT03149640 Completed - Clinical trials for Pneumonia, Ventilator-Associated

Study Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia

AMIKINHAL
Start date: July 19, 2017
Phase: Phase 3
Study type: Interventional

The objective of the study is to prove that after the third day of invasive mechanical ventilation a three-day course of inhaled amikacin reduces the incidence of subsequent VAP. Parallel two group double blind randomized controlled clinical trial. Individual randomization, performed on day 4 of invasive mechanical ventilation, will be stratified on centre in order to account for variations in VAP prevention bundle implementation and use of systemic antibiotics the day of randomization. Patients will be treated three consecutive days with inhaled amikacin or placebo. Patients will be followed up daily in the intensive care unit for the occurrence of VAP according to international guidelines until day 28.

NCT ID: NCT03149432 Completed - Amputation Clinical Trials

Effectiveness of Mirror Therapy in Patients With Amputations of Lower Limbs of Vascular Origin

MIR-PHAN
Start date: February 22, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to assess the efficacy of the mirror therapy on phantom pain for patients with amputation after vascular etiology. the secondary aim are to measure the impact of the mirror therapy on quality of life, sleep disorders, and predictive factors for effectiveness. the design is a prospective study, randomised, blindly evaluated, monocentric. There will be 2 groups: 1) rehabilitation and gabapentine; 2) rehabilitation and gabapentine + mirror therapy during the first 4 weeks. The assessment are going to be preformed at the inclusion day and then every 2 weeks during 8 weeks. the primary evaluation criterion will be the phantom pain measured on a VAS. the delay for inclusion is 18 months in order ton include 40 patients. The length of the study is 20 months.

NCT ID: NCT03149263 Completed - Cerebral Palsy Clinical Trials

Evaluation of the Effect of the Presence Of Clowns on Pain and Anxiety Seen During Injections Botulinum Toxin in Child

CLOWN-TOX
Start date: November 10, 2015
Phase: N/A
Study type: Observational

In children requiring botulinum toxin injections, improving supervisory procedures of injection sessions to reduce pain and improve the experience of this invasive procedure is needed. The intervention of medical clowns seems very interesting in this goal, but its effectiveness has not been proven within the botulinum toxin injections. The objective of the study is to evaluate in terms of profit the presence or absence of clowns during a session of botulinum toxins by determining their impact on pain and anxiety felt among children and their carers

NCT ID: NCT03148938 Completed - Multiple Sclerosis Clinical Trials

Digitalization of Neurofunctional Tests Via a Mobile Application DAMS for Multiple Sclerosis Patients

MSCopilot
Start date: October 2, 2017
Phase: N/A
Study type: Interventional

Multiple Sclerosis (MS) is a chronic immune-mediated inflammatory disease with a broad diversity of symptoms and fluctuating progression patterns. Clinical assessments are challenging and are continually reviewed and enhanced. Optimal multiple sclerosis care depends on early detection of disease progression. The Digital self-Assessment for Multiple sclerosis (DAM) mobile program was developed by Ad Scientiam in order to create a robust and clinically validated remote monitoring platform for MS patients and clinicians. The correlation between DAM version 0 (the first iteration of DAMS) and Multiple Sclerosis Functional Composite (MSFC) has been clinically evaluated in a preliminary study in 30 subjects. DAM version 0 and MFSC global scores were correlated. However, the cognition test had a poor reproducibility and clinicians expressed the wish to measure a walking range rather than a walking speed. Even though vision is the main sense impacting all other tests, particularly when interacting with a mobile, visual tests are rarely performed in real life. A new version of DAM version 0, DAMS, was therefore developed with the addition of the Sloan Low Contrast Letter Acuity Test (SLCLAT), the replacement of the walking speed test with a walking distance test and the Paced Auditory Serial Addition Test (PASAT) by a new version of the cognitive test which resembles the Symbol Digit Modalities Test (SDMT). The hypothesis is that systematic and prospective multi-dimensional data collection of MS disabilities through the DAMS mobile application will refine the quality and accuracy of both clinicians and patients' knowledge of the disease progression and will ultimately improve the current care of patients. To test this assumption, the statistician will analyze: 1. The global diagnostic performance of DAMS with (DAMS 4 tests) and without (DAMS 3 tests) the low contrast vision test versus standard MS scales 2. The test-retest reliability of DAMS' scores at a 15 day interval

NCT ID: NCT03148886 Completed - Clinical trials for Metastatic Breastcancer

Advanced Breast Cancer and Lifestyle Exercise Study

ABLE
Start date: October 2016
Phase: N/A
Study type: Interventional

About 5% of breast cancers are metastatic at diagnosis and 20-30% of localized breast cancer become secondarily metastatic.Thanks to recent therapeutic advances, the median survival ranges between 12 months in 1970 and 18 to 24 months in 2000. However, patients suffer from many detrimental symptoms such as fatigue, pain related to treatment and metastasis. The physical, biological, psychological and clinical benefits of physical activity (PA) during treatment in patients with localized breast cancer have been widely demonstrated. Numerous studies investigated the effect of PA in non-metastatic breast cancer, but to our knowledge, only four interventional studies worldwide focused on the implementation of PA in patients with metastatic breast cancer.It seems appropriate to investigate the feasibility of PA intervention with patients with metastatic breast cancer to see if the observed effects in localized breast cancer are confirmed in metastatic breast cancer population. The ABLE study is an interventional cohort designed to assess the feasibility of a 6-month adapted physical activity intervention, performed under real life conditions in patients with metastatic breast cancer.