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NCT ID: NCT02911506 Completed - Sleep Quality Clinical Trials

Sleep Quality in Intensive Care Unit Patients at High Risk of Extubation Failure

WEAN SLEEP 2
Start date: November 2015
Phase:
Study type: Observational

The aim of the study is to evaluate the impact of sleep quality on extubation failure rate in intensive care unit patients at high risk.

NCT ID: NCT02911402 Completed - Sea Sickness Clinical Trials

Motion Sickness on Astrolabe's Vessel

SICKVEST
Start date: October 2014
Phase:
Study type: Observational

Sea sickness syndrome is present for 80% of persons on board when the boat rotation missions Astrolabe, sometimes there is a risk of very significant dehydration. A special unit specialized in the fundamental study of the vestibular system (inner ear), sensory organ at the base of visual-vestibular conflict inducing this syndrome, also provides medical support for parabolic flights (flight reproducing weightlessness) where this syndrome is strongly present. The goal of the study is to assess the frequency of occurrence of this sea sickness syndrome on the Astrolabe, to understand the triggers (type of boat movements, personality traits, anxiety / stress) without changing habits on board for those on board taking a antinaupathique treatment given by the ship's doctor. This study will be done in collaboration between INSERM U 1075 (France) and the Laboratory of military research VIPER specialized in extreme environments (Belgium). The ultimate goal will be to provide the best recommendations and the best treatment regimen to alleviate as best as possible the symptoms of people on board of the Astrolabe so scientists on board can perform their work.

NCT ID: NCT02911233 Completed - Hemophilia A Clinical Trials

Evaluation of Clot Stability Induced by Solulin: Evaluation of New Solulin Mutants Lacking Protein C Activation Capacity

SOLUCLOT
Start date: March 2014
Phase: N/A
Study type: Observational

Hemophilia A is a rare X chromosome-linked recessive bleeding disorder that concerns one individual in 5000. In its severe form, hemophilia A is a life-threatening, crippling hemorrhagic disease. The treatment of bleeding episodes in hemophilia A patients involves the administration of exogenous human FVIII to restore normal hemostasis. The main complication of the substitutive treatment of hemophilia A is the development, in 15 to 30% of the cases, of anti-FVIII antibodies (FVIII inhibitors) that neutralize the pro-coagulant activity of therapeutically administered FVIII. In 2003, the average annual cost of care for a patient with hemophilia A was evaluated to be equal to 63,000 euros (2), which, in France (6000 patients), represents an annual budget of 378 million euros. In order to reduce the cost of treatment and to bypass this complication, different therapeutic strategies (new products or adjunctive therapeutic options) have been explored, including platelet infusion, tranexamic acid, amino caproic acid, molecules that block tissue factor pathway inhibitor, combination of phospholipid -Factor Xa- Factor XIII and antibodies directed to the Tissue Factor Inhibitor Pathway (TFPI). Recently, Soluble thrombomodulin (Solulin) have been developed. This molecule may be used to partially correct the premature lysis defect in Factor VIII deficient plasma through an activated TAFI - dependent mechanism. With a long half-life (15- to 30-hour) and effective dose range estimated to range from the sub-nanomolar to approximately 40nM, Solulin could potentially be administered on a weekly basis and provide the basis for a factor-sparing regime that would cut costs and make therapy more widely available. However, before proceeding to advanced trials, safety concerns stemming from the anticoagulant properties of Solulin must be addressed. The development of Solulin mutants lacking protein C activation capacity would make this concern redundant. At the same time, such mutant molecules are likely to possess an effective dose range. Our project is to compare the behavior of recombinant Solulin and mutants of Solulin lacking protein C activation capacity with respect to their ability to stabilize fibrin clots in whole blood of humans with different coagulation factor deficiencies (hemophilia A, hemophilia B and rare blood coagulation deficiencies (factor X, VII, V).

NCT ID: NCT02911207 Completed - Educational Therapy Clinical Trials

Evaluation of Emotion Management Skill Strengthening in Chronically Ill Patients, Benefiting From Creative and Physical Activities

EvAd
Start date: August 29, 2016
Phase: N/A
Study type: Interventional

There are very few studies on emotion management in chronically ill patients. They usually include small sample size (less than 30 persons) and are not randomized controlled trials. However, emotion management is an essential coping skill in mental well-being and quality of life and is the subject of numerous studies in psychology.The investigators hypothesized that a creative and physical activities combination in chronically ill will promote the strengthening of emotion management skill. The investigators will conduct an innovating study combining quantitative and qualitative variables in a randomized controlled trial to confirm our hypothesis.

NCT ID: NCT02911051 Completed - Clinical trials for Intermittent Urethral Catheterization

Clinical Study Evaluating the Safety of a New Catheter for Urinary Intermittent Catheterization in Self Catheterized Patients

Start date: September 2, 2016
Phase: N/A
Study type: Interventional

The clinical study evaluates the safety of a new catheter for Urinary Intermittent Catheterisation in self catheterized patients

NCT ID: NCT02910856 Completed - Clinical trials for Infective Endocarditis

Infective Endocarditis in the Elderly

ELDERL-IE
Start date: March 2015
Phase:
Study type: Observational

ELDERL-IE is a multicenter national prospective observational study. The main objective is to describe geriatric characteristics (comorbidities, cognitive status, autonomy, nutritional status, balance and walking) in patients aged 75 years or older with infective endocarditis (IE). The secondary objectives are to assess the impact of geriatric features on the medico - surgical care and on morbidity and mortality at 3 months after the end of the hospitalization, and to describe the initial clinical presentation and diagnostic modalities in the IE elderly.

NCT ID: NCT02910622 Completed - Breast Cancer Clinical Trials

Pilot Study Evaluating the Oncogramme: Analysis of Response to Induction Treatment of Patients With Breast or Ovarian Cancer.

ONCO S-O
Start date: June 2012
Phase: N/A
Study type: Observational

The choice of treatments for cancers by systemic way - chemotherapy, hormone therapy and targeted therapies - is currently defined by criteria for population groups and not to an individual. These expensive treatments - in financial terms and quality of life - will be effective for some and administered unnecessarily for other because there is no predictive test of response for a given individual. For breast cancer, the usual treatment includes the first surgery and adjuvant therapies (chemotherapy, hormonal therapy ...) whose effectiveness will be assessed after many years as the occurrence or not of a recurrence or metastases. These systemic treatments can also be administered before surgery to reduce the tumor volume and secondarily allow less mutilating surgery: it is the principle of treatment neo adjuvant. In this case, the efficiency will be evaluated more quickly. In practice, a patient with breast cancer suspicion has a biopsy which confirms the diagnosis and defined the parameters (hormone receptors, cytological grade, receptor monoclonal antibodies ...) that guide to the most appropriate type of treatment. Tumor size is evaluated in neo adjuvant pre-treatment by imaging: mammography, ultrasound and MRI. At the end of this medication, the evaluation of the response is achieved by radiology and surgery. Pathological examination evaluates and precise response by the criteria of Chevallier and / or Sataloff. An ex vivo test for predicting the response of cells to different chemotherapy regimens, the oncogramme, was developed by Oncomedics, a young company whose technology is derived from the University of Limoges. Clinical response and / or histopathological could be compared in a reasonable time (2-6 months), the results of the oncogramme proposed by Oncomedics whether the efficiency obtained in vivo is that predicted by the ex vivo test. It is the same in the metastatic setting when there is an available target for biopsy and assessment of response. The management of ovarian cancer in advanced stages can also benefit from a radiological and histopathological evaluation strategy before and after systemic treatment to compare the in vivo results with those predicted by ex vivo by Oncomedics.

NCT ID: NCT02910479 Completed - Healthy Volunteers Clinical Trials

Study Evaluating the Relevance and Reliability of Gastrointestinal Temperature Measurements From a New Device (E-celsius)

e-TEMP
Start date: November 2015
Phase: Phase 1
Study type: Interventional

E-Celsius device used for measuring the gastrointestinal temperature is composed of an ingestible capsule measuring the temperature as well as a transportable module receiving data from the capsule. This device allows to measure the body temperature (± 0.2 ° C) during transit of the pill in the digestive tract to a maximum sampling frequency of 30 seconds. The main risks related to such devices are related to biocompatibility (in materials used for the capsule shell, or level of contamination of the gastrointestinal environment due to a defect in the plastic envelope the pill or a lack of hygiene, previously tested in clinical trials; see section 10.2). It will compare conventional methods of estimating the central temperature continuously with gastrointestinal data obtained from the e-Celsius device. The main objective of the research is to validate the extent of gastrointestinal temperature obtained from the device under test consists of an ingestible electronic capsule and a data reception monitor. Secondary objectives will be pursued: - Assess the effects of ingestion of cold drinks on temperature readings taken via e-device Celsius, esophageal probe and a rectal probe. - Explore the thermal homogeneity of the digestive tract. - Evaluate the internal memory of the capsule and its data forwarding capacity. This protocol will also measure the reliability of the measurement system while comparing it to the standards used by health staff today.

NCT ID: NCT02910258 Completed - Myelofibrosis Clinical Trials

Interferon-pegyle α2a Efficiency and Tolerance in Myelofibrosis

PEG-MF
Start date: September 2012
Phase:
Study type: Observational

Patients who carried primary or secondary myelofibrosis from Philadelphia negative MPNs (PMF/SMF) and who are treated or are about to be treated with pegylated-interferon (mostly α2a) are eligible to this prospective study. Biological and clinical parameters will be collected from the beginning of the drug use until last news. A non-opposition consent form need to be signed before entering this study.

NCT ID: NCT02909816 Completed - Clinical trials for Dental Carie; Orthodontics

Adverse Event Risk Assessment in the Use of Nitrous Oxide for Pediatric Dental Patients

Start date: April 2015
Phase:
Study type: Observational

The objective was to assess adverse event risk in the use of Nitrous Oxide for Pediatric Dental Patients. The investigators performed a multicenter observational study. The investigators included patients aged 1 to 18 years and who have already failed dental care because of non-cooperation; they could be with mental or cognitive disabilities and could have sedative premedication. The investigators performed any type of dental care With the Use of Nitrous Oxide/Oxygen Sedation. The primary outcome was vomiting assessed during or after dental care.