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NCT ID: NCT03603314 Completed - Clinical trials for Severe Sudden Sensorineural Hearing Loss

Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss

AUDIBLE-S
Start date: February 15, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Primary objective of the study is to assess the efficacy of SENS-401 on hearing loss in comparison to placebo at the end of the 4-week treatment period

NCT ID: NCT03602651 Completed - Anxiety Disorders Clinical Trials

MAGZEN® Effect on Recent Anxiety Reaction

STRESS2
Start date: November 8, 2019
Phase:
Study type: Observational [Patient Registry]

Multicentres, observational study, prospective, to evaluate the effect of MAGZEN® in the treatment of recent anxiety reaction.

NCT ID: NCT03602560 Completed - Clinical trials for Primary Biliary Cholangitis

ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.

NCT ID: NCT03602521 Completed - Clinical trials for Borderline Personality Disorder

Reactivity of Patients With Borderline Personality Disorder to an Ecological Interpersonal Stress

ROI
Start date: February 27, 2019
Phase: N/A
Study type: Interventional

Use lay language. According to the World Health Organization 1 death by suicide occurs every 40 seconds, leading suicide prevention to one of the public health priority. BPD (Borderline Personality Disorder) is a common condition affecting 6% of the population. This disorder is characterized by unstable emotions, unstable mood, difficulties with relationship and feer of abandonment. Borderline Personality Disorder is also the psychopathology the most related to suicidal attempts. Indeed, up to 50% of the patients admitted to hospital after a suicide attempt are diagnosis with a Borderline Personality Disorder Negative interpersonal events (events occurring between two people) are known as the main stressor that trigger a suicidal attempt. People with a Borderline Personality Disorder are highly sensitive to it. Moreover, neuropeptides such as oxytocin (OXT), vasopressin and opioid are known to be involved in the regulation of the emotions, especially those linked to relationship. The purpose of this study is to improve knowledge in suicidal behaviors. After simulating an interpersonal stress, the evolution of plasma neuropeptides level (OXT, vasopressin and opioid) of patients with a BPD will be compared to healthy controls (HC). Clinical data reflecting how the participant is feeling will be collected as well.

NCT ID: NCT03602339 Completed - Clinical trials for Magnetic Resonance Imaging

Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose

LEADER 75
Start date: November 14, 2018
Phase: Phase 4
Study type: Interventional

The study was conducted to gain knowledge about a new dose of a diagnostic drug that is used for contrast-enhanced Magnetic Resonance Imaging (MRI) of the human central nervous system (CNS). MRI can visualize the anatomy of the body and is used to detect medical conditions. Diagnostic drugs like gadobutrol and gadoterate contain an element called gadolinium that is applied to improve the analysability of MRI-images. The purpose of this study was to examine if contrast-enhanced MRI using a reduced dose of the gadolinium-based contrast agent gadobutrol delivers images of similar quality to those obtained when a full dose of the gadolinium-based contrast agent gadoterate was used.

NCT ID: NCT03600792 Completed - Clinical trials for Fetal Agenesis of the Corpus Callosum (ACC)

Whole Exome Sequencing in Prenatal Diagnosis of Agenesis of the Corpus Callosum

EXACC
Start date: August 28, 2018
Phase:
Study type: Observational

Agenesis of the corpus callosum (ACC) is one of the most frequent cerebral malformations and is now diagnosed prenatally in most cases. Prenatal counseling is then challenging because of uncertain neurodevelopmental outcome, depending on the genetic cause of ACC. Our purpose is to evaluate the feasibility of sequencing known genes responsible for ACC by whole exome sequencing (WES) in trio (fetus and both parents) when ACC is diagnosed during the pregnancy, in order to provide complete and loyal information on the intellectual prognosis for the fetus.

NCT ID: NCT03600636 Completed - Clinical trials for Antiphospholipid Syndrome

Medium-term Follow-up of Patients With Obstetric Antiphospholipid Syndrome: MRI Study of White Matter

APS Follow Up
Start date: December 7, 2018
Phase: N/A
Study type: Interventional

The investigators hypothesize that the white matter of patients with obstetric antiphospholipid syndrome deteriorates over time

NCT ID: NCT03600181 Completed - Clinical trials for Intubation Complication

Non-invasive Technology for Early Signal Detection of Hypoxemia With ORI During Intubation

NESOI
Start date: February 11, 2019
Phase:
Study type: Observational

Intubation of patients in the intensive care unit (ICU) carries a risk of potentially severe complications, including cardiac arrest. Hypoxemia is common in ICU patients requiring intubation, which must be performed rapidly to avoid aspiration, since the patient is usually not in the fasted state. Studies have assessed interventions designed to improve intubation success rates, such as routine neuromuscular blockade. Care bundles combined with training on simulators have improved the safety of intubation. Nevertheless, intubation in the ICU still carries higher morbidity and mortality rates compared to intubation in the operating room. Preoxygenation is a cornerstone of safety for intubation in the ICU. Several recent trials have investigated different devices (non-rebreather mask, non-invasive ventilation, high flow nasal cannula, bag valve mask) with conflicting results. A main reason for those results is that efficiency of the preoxygenation period cannot be evaluated in the ICU in opposite to the operating room: gas monitoring are not available in ICU and even if it was the case, high flow demand from the patient, and agitation will make it inefficient. Additionally, desaturation is frequent (from 10% up to 50%) during intubation in ICU and lead to morbidity and mortality; so anticipation of desaturation is a major concern for ICU's physician because it's impacting care (face mask ventilation, early insertion of subglottic device). The oxygen reserve index (ORI) is a new parameter for monitoring oxygen reserve non-invasively. In this context, the investigators purpose to analyze efficiency of preoxygenation and time allowed by ORI for medical interventions before hypoxemia during intubation in the ICU in a pilot observational study in our medical ICU in a university hospital.

NCT ID: NCT03599999 Completed - Clinical trials for Bacterial Infection With One or More Extended Spectrum Betalactamases Remaining Susceptible to Temocillin

Study of Adverse Effects Occuring in Patients Receiving an Antibiotic Treatment With Temocillin

Témocilline
Start date: March 24, 2017
Phase:
Study type: Observational

The Temocillin prescription frequency may be increased in order to reduce the use of carbapenems to reduce the progressive increase in carbapenem resistance observed in recent years. The investigators wish to study the responsibility of Temocillin in the occurrence of adverse effects in patients in the hospital of Amiens receiving a treatment containing this molecule.

NCT ID: NCT03599830 Completed - Clinical trials for Patients With Cancer Who Start Immunotherapy

Study of the Cognition of Patients Treated With Immunotherapy

COG-IMMUNO
Start date: July 10, 2018
Phase: N/A
Study type: Interventional

The investigator's longitudinal pilot study aims to evaluate for the first time the impact of immunotherapy on cognition in oncology. Due to the recent nature of immunotherapy, its side effects and impact on quality of life are still poorly understood and, to date, there is no published study evaluating the impact of immunotherapy on cognition in patients treated for cancer. The study consists of the passation of 3 neuropsychological assessments over a period of 6 months in cancer patients who start immunotherapy