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NCT ID: NCT03535194 Completed - Psoriasis Clinical Trials

A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)

Start date: June 26, 2018
Phase: Phase 3
Study type: Interventional

The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.

NCT ID: NCT03535181 Completed - Clinical trials for Aneurysm, 4D CT Scan

Pulsatility Aneurysmal Evaluation Process by Cerebral Dynamic CTA (Computed Tomography Angiography)

PULSAN
Start date: April 20, 2018
Phase:
Study type: Observational

Intracranial aneurysm are frequent with a prevalence estimated over 2-5% in the general population. These are focal dilatations occuring in the cerebral vessels. They usually remain silent until complications occur. Complications associated with intracranial aneurysms include mass effect on adjacent structures and rupture. Rupture is the most severe complication with a mortality rate of 35-50% and a high rate of morbidity including long-term disability. It incidence is estimated about 1% per year for aneurysm smaller than 1 cm. However, preventative treatments have their own risk of complication and morbi-mortality rate including stroke and hemorrhage. Actual guidelines for treatment planning are mainly designed with the size, the location and the age of the patient. This is why working on the identification of imaging markers of aneurysmal instability is relevant. Dynamic CTA (Computed Tomography Angiography) acquisition allow to study the variation of metrics such as dome height, dome length, ostium width, ostium area, and volume during the cardiac cycle. The goal of this study is to assess different aneurysmal metrics to determine those which may vary the most during the cardiac cycle and to assess it as an imaging marker of aneurysmal instability.

NCT ID: NCT03533842 Completed - Emergencies Clinical Trials

Validation of a Computerized Triage Algorithm for Ophthalmic Emergencies

iCare
Start date: March 27, 2018
Phase:
Study type: Observational

The investigators conceived a computerized interactive tool for Emergency Triage, based on a patient's symptoms, medical history and background. Using this tool, the patient (alone or helped by a nurse / supporting person) presenting to an ophthalmologic ER, should be able to detect and prioritize his most urgent symptoms (A,B), in opposition to less urgent (C) or non urgent symptoms (D). To test the validity of this tool, each patient presenting at the Rothschild Foundation ER (Paris, France) with an ophthalmological problem should be included and sorted by the algorithm before the medical consultation. Neither the patient nor the practitioner are aware of the scoring (A,B,C,D) defined by the algorithm. The practitioner should then give his own emergency scoring (A,B,C,D) after patient examination. A total of 1000 patients is expected.

NCT ID: NCT03533114 Completed - Clinical trials for Idiopathic Hypersomnia

A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension

Start date: November 27, 2018
Phase: Phase 3
Study type: Interventional

This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.

NCT ID: NCT03530384 Completed - Clinical trials for Alcohol Use Disorder

Training Inhibition in Alcohol Use Disorder

TRAIN
Start date: February 25, 2019
Phase: N/A
Study type: Interventional

More and more studies aim to improve neurocognitive functioning in alcohol use disorder, but very few studies have focused on training-inhibitory-control efficacy on alcohol intake. Our program relies on a comprehensive model of addiction considering inhibition deficit as the hallmark of addiction. Our program proposes inhibition training on a task which does not refer to alcohol, combined with a debriefing promoting transferability of the enhanced skill and psychoeducation. In this perspective of aiming to retrain deficits involved in addiction in itself and not only due to alcohol toxicity. We propose an add-on single-blinded randomized controlled trial, in alcohol use disorder, assessing the efficacy of a computerized cognitive training program targeting inhibition as compared to treatment as usual.

NCT ID: NCT03530371 Completed - Clinical trials for Auditory Brainstem Response

Intranasal Dexmedetomidine for Sedated Hearing Testing

Start date: May 2, 2019
Phase: Phase 3
Study type: Interventional

Auditory brainstem response testing is necessary in children who are not able to be tested by classical audiogram, because of their age or an associated retarded psycho-motor development or behavioral and cognitive troubles. This test needs a perfect immobility of the child, ideally being asleep. This situation is sometimes impossible to achieve in non-cooperative children. Currently, in the Pediatric Hospital of Nice, the investigators have to do a general anesthesia to perform quality auditory response tests in this kind of patients. The alternative to a general anesthesia would be a reliable sedative drug, allowing the performance of this diagnostic exam without the need of a hospitalization. Dexmedetomidine is a sedative drug with an action on the α2 adrenergic receptors. It causes a rapid sedation, similar to the natural sleep and with minimal secondary effects. The possibility of an intranasal administration, avoids the pain and discomfort of a venous access insertion.

NCT ID: NCT03530215 Completed - Cancer Clinical Trials

Evaluation of Reporting of Cardio-vascular Adverse Events With Antineoplastic and Immunomodulating Agents (EROCA)

EROCA
Start date: May 2, 2018
Phase:
Study type: Observational

Antineoplastic and immunomodulating agents may lead to various cardio-vascular adverse reactions. This study investigates reports of cardio-vascular toxicities for treatment including Anatomical Therapeutic Chemical (ATC) classification L (antineoplastic agents, endocrine therapy, immunostimulants, and immunosuppressants drugs) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).

NCT ID: NCT03530059 Completed - Lung Cancer Clinical Trials

Fast-Track Rehabilitation

FTR
Start date: February 9, 2018
Phase:
Study type: Observational

This study is a prospective observational study which aim to evaluate the feasibility of a total and systematic home respiratory rehabilitation training program in patients who will undergo thoracic surgery, and otherwise tend to define failure reasons.

NCT ID: NCT03529877 Completed - Clinical trials for Recessive Dystrophic Epidermolysis Bullosa

Allogeneic ABCB5-positive Stem Cells for Treatment of Epidermolysis Bullosa

Start date: February 16, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this clinical trial is to investigate the efficacy (by monitoring overall improvement of EB symptoms) and safety (by monitoring adverse events) of three doses of allo-APZ2-EB administered intravenously to patients with recessive dystrophic epidermolysis bullosa (RDEB).

NCT ID: NCT03529383 Completed - Breast Cancer Clinical Trials

Efficacy of Exercise Using Connected Activity Trackers and Therapeutic Education in Localized Breast Cancer

DISCO
Start date: May 18, 2018
Phase: N/A
Study type: Interventional

The 3-year DISCO study aims to systematically implement physical activity in breast cancer patients. The primary objective is to investigate the efficacy of a connected device (personalized non-supervised exercise program including a wristband as activity tracker, a smartphone application, and a website) and the efficacy of a therapeutic education program on the physical activity level of patients at the end of the 6-month programs. The research hypothesis is that patients participating in the intervention with the connected device or in the therapeutic education program will achieve the international recommendations in terms of physical activity, compared to women receiving only physical activity recommendations.