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NCT ID: NCT03765892 Completed - Narcolepsy Clinical Trials

Study of the Academic and Professional Course of Narcoleptic Patients (NARCOSCOL-NARCOVITAE)

Start date: February 27, 2020
Phase:
Study type: Observational

Narcolepsy is a chronic, disabling, and rare sleep disorder (prevalence 1/2500) characterized by excessive daytime sleepiness and, in some patients, falls in muscle tone related to emotions (cataplexies). It often begins in childhood or in young adults. Symptoms of narcolepsy are responsible for an important handicap in everyday life, and are often misunderstood by the family and professional environment. In addition, many comorbidities are associated with narcolepsy, such as depression, anxiety, or obesity. Few studies have investigated the impact of narcolepsy on patients' academic background, socio-professional integration, and quality of life. Narcoleptic patients may experience more difficulties in their academic and professional path than non-narcoleptic people. These difficulties would be multifactorial (related to the disease itself, comorbidities, external factors ...). As a better understanding of these determinants could help to inform patients and guide them in their choices, this study propose to establish a comprehensive inventory of educational and professional trajectories of narcoleptic patients in France in order assess the specificity of the difficulties encountered by the people concerned in their life course and to appreciate the attitude of the academic and professional circle with respect to the disease. This category 3 study (according to the French law "Loi Jardé") is based on the case-control model and will be conducted in all National Reference and Competence Centers for Narcolepsy and Hypersomnia. It will include a population of adult and paediatric patients. It will answer questions about work and schooling in these patients.

NCT ID: NCT03765853 Completed - Lower Back Pain Clinical Trials

Randomized Study on the Evaluation of the Regular Practice of Standardized Postures Stretching Postural® in Secondary Prevention of Low Back Pains During Pregnancy.

GEMALODO
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Lower back pain (LBP) during pregnancy is a frequent syndrome: it concerns two thirds of pregnant women. This complaint isn't routinely searched for and therefore underdiagnosed. Furthermore, few solutions are given to these women in order to reduce their pain, and indirectly to improve everyday life. What's more, LBP is the cause of many work interruptions. Physical exercise during pregnancy is recommended by the National College of Gynaecologists and Obstetricians for low risk pregnancies. Several techniques have proven to be efficient. The main objective of our study is to assess the benefit of regular practice of standardised Stretching Postural® postures in patients presenting "de novo" lower back pain during pregnancy. The Stretching Postural® technique comprises of static postures involving muscular contractions and stretches. This allows the strengthening of the postural muscles, including the paravertebral muscles. After a short learning period, postures can be done autonomously by the patients. The postures are adaptable to each and everyone's morphology and physical limitations. Our study is an open, prospective, randomised monocentric superiority trial in parallel branches involving major patients during low risk pregnancies. These women suffer from "de novo" lower back pain during the second and third trimesters of their pregnancies. Each patient will be randomly assigned to one of the following 2 groups: - Stretching Postural® group (group A): usual prevention methods (ergonomic education) and Stretching Postural® postures. - "Control" group (group B): usual prevention methods only. Patients presenting "de novo" LBP are included in the study after a routine consult then randomly separated into two groups. During the initial consult, the physician assesses inclusion and judgement criteria, collects informed consent from the patients and teaches them the usual prevention methods as well as, concerning group A, Stretching Postural® postures. Computerized support agendas are given in order to improve observance. Patients are evaluated at day 0 (initial evaluation), after 4 weeks (intermediate) and after 8 weeks (final), according to the main judgment criterion, as well as on secondary pain criteria by the Concise Pain Questionnaire, on their quality of life, the rate of work interruptions and their satisfaction rate. Neonatal outcome is collected at birth. Intermediate phone interviews will allow psychological support and improve observance. Inclusion is scheduled to last 22 months; each subject will be followed during a period of 2 months. The total duration of the study is 2 years. Expected results are a decrease in back pain and an improvement of the quality of life in group A. Decrease in pain scale, equivalent to overall pain during the last week between the two groups will be our main judgment criterion. In order to detect a difference of 1.5 pain scale points (on a scale from 1 to 10) with an alpha risk of 5%, 80% magnitude and a standard deviation of 2, 56 subjects are necessary; 28 in each group. Perspectives: This study will allow for a better diagnosis of lower back pain during pregnancy, and, consequently, for the implementation of routine means of care such as collective or private lessons in Stretching Postural® and the supply of personalised prevention documents.

NCT ID: NCT03764618 Completed - Clinical trials for Warm Antibody Autoimmune Hemolytic Anemia

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA

Start date: April 24, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

NCT ID: NCT03763773 Completed - Clinical trials for Acute Respiratory Distress Syndrome

Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome

PreMiTE-ARDS
Start date: April 21, 2019
Phase:
Study type: Observational

The Superior Vena cava Respiratory Collapse Index (cVCS) is a haemodynamic parameter measured exclusively by transoesophageal ultrasound (TEE), which is used to assess cardiac precharge-dependence status. This may be an important prognostic factor in ARDS because it is a sign of hypervolemia and right heart failure.

NCT ID: NCT03763188 Completed - Acute Kidney Injury Clinical Trials

Dialysis Weaning in Intensive Care Units (Dialysis STOP)

D-STOP
Start date: September 1, 2016
Phase:
Study type: Observational

Evaluation of daily urinary urea excretion, to guide Renal Replacement Therapy weaning, in Intensive Care Units. The objective is to show that remove the dialysis catheter, once daily urinary urea excretion is greater than 1.35 mmol/kg/d, would increase more than 3 days the number without dialysis catheters, and thus without dialysis, the first 28 days after insertion. Daily urinary urea excretion = urea (mmol/L) x diuresis (L/d) / weight (kg).

NCT ID: NCT03762447 Completed - Solid Tumors Clinical Trials

A Study Exploring the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB086550 in Participants With Advanced Solid Tumors

Start date: December 10, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics, and early clinical activity of INCB086550 in participants with advanced solid tumors who have failed prior treatments.

NCT ID: NCT03761849 Completed - Huntingtons Disease Clinical Trials

A Study to Evaluate the Efficacy and Safety of Intrathecally Administered RO7234292 (RG6042) in Participants With Manifest Huntington's Disease

Start date: January 23, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety, and biomarker effects of RO7234292 (RG6042) compared with placebo in participants with manifest Huntington's disease (HD)

NCT ID: NCT03761654 Completed - Clinical trials for Left Ventricular Dysfunction

Detection of Myocardial Dysfunction in Non-severe Subarachnoid Hemorrhage (WFNS 1-2) Using Speckle-tracking Echocardiography (STRAIN)

SAH-STRAIN
Start date: January 2, 2019
Phase:
Study type: Observational

Subarachnoid hemorrhage (SAH) can cause transient myocardial dysfunction. Recently, it have been reported that myocardial dysfunctions that occur in SAH are associated with poor outcomes. It therefore appears essential to detect theses dysfunctions with the higher sensitivity as possible. Strain measurement using speckle-tracking echocardiography may detect myocardial dysfunction with great sensitivity. The main objective of this study is to assess the prevalence of myocardial dysfunction in "non-severe" SAH (defined by a WFNS grade 1 or 2), using speckle-tracking echocardiography. This study also aims to analyse Strain measurement with classical echocardiography and serum markers (troponin, BNP) of cardiac dysfunction.

NCT ID: NCT03761537 Completed - Atopic Dermatitis Clinical Trials

Tralokinumab in Combination With Topical Corticosteroids in Subjects With Severe Atopic Dermatitis - ECZTRA 7

ECZTRA 7
Start date: December 13, 2018
Phase: Phase 3
Study type: Interventional

Primary objective: To demonstrate that tralokinumab in combination with topical corticosteroids (TCS) is superior to placebo in combination with TCS in treating severe AD in subjects who are not adequately controlled with or have contraindications to oral cyclosporine A (CSA). Secondary objectives: To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, and health-related quality of life compared to placebo in combination with TCS. To evaluate the safety of tralokinumab in combination with TCS when treating severe AD in subjects who are not adequately controlled with or have contraindications to oral CSA compared to placebo in combination with TCS.

NCT ID: NCT03761407 Completed - Acute Pain Clinical Trials

A Clinical Study in Healthy Subjects Which Aims to Investigate the Safety, the Tolerability and the Effects of GRT0151Y and How the Compound is Taken up and Excreted From the Body

Start date: December 30, 2004
Phase: Phase 1
Study type: Interventional

The aim of this clinical study in healthy participants is to investigate the safety and tolerability of GRT0151Y after multiple oral intake of different increasing doses and to evaluate the pharmacological effects (action of the compound) by means of pupillometry (measuring the pupil size of the eye) and Cold Presser Test (measuring the pain when immersing the hand in 2 degree Celsius cold water). An additional aim of the study is to investigate the pharmacokinetics of GRT0151Y (how it is taken up into the body and how it is excreted from the body)."