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NCT ID: NCT03373422 Terminated - Endometriosis Clinical Trials

A Study to Test Whether Study Drug BAY1128688 Brings Pain Relief to Women With Endometriosis and if so to Get a First Idea Which Dose(s) Work Best

AKRENDO1
Start date: November 30, 2017
Phase: Phase 2
Study type: Interventional

Purpose of the study is to test whether study drug BAY1128688 brings relief for pain to women with endometriosis and if so to get a first impression which dose(s) work best.

NCT ID: NCT03371498 Terminated - Persistent ARDS Clinical Trials

Procollagen-3 Driven Corticosteroids for Persistent Acute Respiratory Distress Syndrome

ProCoCo
Start date: December 27, 2018
Phase: Phase 3
Study type: Interventional

Unresolved ARDS is defined by the persistence of ARDS criteria at the end of the first week of evolution despite an appropriate treatment of the cause of ARDS. A persistent ARDS is associated with an increased mortality and prolonged lengths of mechanical ventilation, ICU stay and hospitalization. Persistent ARDS is characterized by ongoing inflammation, parenchymal-cell proliferation, and fibroproliferation leading to disordered deposition of collagen. All of these pathways may be responsive to corticosteroid therapy. Only two randomized controlled double-blinded trials assessed the use of corticosteroids for persistent ARDS. In 24 patients, Meduri et al. reported an improvement of lung function and survival (1). In 180 patients, Steinberg et al showed no effect of corticosteroids on survival (2). A lower risk of death was observed when corticosteroids were started before 14 days after the onset of ARDS (2). Alveolar procollagen III is validated as a biomarker of active fibroproliferation. Alveolar procollagen III > 9 µg/L is associated to fibroproliferation (3). As mortality was lower in patients who received corticosteroids while presenting a high alveolar level of procollagen III on inclusion, Steinberg et al. showed that patients presenting with a low level of procollagen III and treated with corticosteroids had an increased risk of death (2). Investigatores hypothesize that the use of procollagen III could improve personalized decision-making regarding steroid treatment in patients presenting with persistent ARDS. The future of anti-fibrotic treatment, including corticosteroids, in persistent ARDS might propose to individualize the therapy according to the presence of an active fibroproliferative phase (precision or personalized medicine).

NCT ID: NCT03370601 Terminated - Clinical trials for Inflammatory Bowel Diseases

Evaluation of the Clinical and Immunological Impact of Two Therapeutic Strategies in Chronic Inflammatory Diseases

STAMP
Start date: January 3, 2017
Phase: N/A
Study type: Interventional

This study evaluates 2 therapeutic strategies (increase infliximab dose or add an immunosuppressant) in patients with inflammatory bowel disease in loss of response to infliximab. Addition of an immunosuppressant may be more efficient at long term and is less expensive.

NCT ID: NCT03370120 Terminated - Clinical trials for Drug-Resistant Epilepsy

Study to Test the Safety and Efficacy of Padsevonil as Adjunctive Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant Epilepsy

Start date: August 27, 2018
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the long-term safety and tolerability of Padsevonil administered at individualized doses as adjunctive treatment for subjects with drug-resistant epilepsy.

NCT ID: NCT03369509 Terminated - Clinical trials for Allergic Hypersensitivity Drug Reaction Versus Non-allergic Hypersensitivity Drug Reaction Cross Reaction

Allergic Versus Non Allergic Hypersensitivity Drug Reaction (BdDAllergo)

BdDAllergo
Start date: May 29, 2017
Phase:
Study type: Observational

The creation of a database containing the medical data of patients followed in allergology at the University Hospital of Grenoble will permit to study allergic versus non-allergic hypersensitivity drug reaction as well as the risk of cross-reactions between medicinal drugs belonging to the same pharmacological class. The main objectives of the study are to estimate and to compare the proportion of allergic hypersensitivity drug reaction and the proportion of non allergic hypersensitivity drug reaction, and to characterize these two types of hypersensitivity drug reaction on clinical, biological and chronological aspects. In a second time, ancillary study will be conducted in order to : - identify drugs that potentially induced histamine-liberation in patients diagnosed with non allergic hypersensitivity drug reaction - investigate the risk of cross-reactions between drugs belonging to the same pharmacotherapeutic class in patients diagnosed with allergic hypersensitivity drug reaction.

NCT ID: NCT03367819 Terminated - Prostate Cancer Clinical Trials

Isatuximab in Combination With REGN2810 (Cemiplimab) in Patients With Advanced Malignancies

Start date: January 4, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objectives: - To characterize the safety and tolerability of isatuximab in combination with REGN2810 in participants with metastatic, castration-resistant prostate cancer (mCRPC) who were naïve to anti-programmed cell death-1 (PD-1)/programmed cell death-ligand 1 (PD-L1)-containing therapy, or non-small cell lung cancer (NSCLC) who progressed on anti-PD-1/PD-L1-containing therapy, and to confirm the recommended Phase 2 dose (RP2D). - To assess the response rate of isatuximab in combination with REGN2810 in participants with either mCRPC who were anti-PD-1/PD-L1 therapy naive, or NSCLC who progressed on anti-PD-1/PD-L1 therapy, or of isatuximab as single agent in participants with mCRPC. Secondary Objectives: - To evaluate the safety of the combination of isatuximab with REGN2810 or isatuximab monotherapy. - To evaluate the immunogenicity of isatuximab and REGN2810. - To characterize the pharmacokinetic (PK) profile of isatuximab single agent or in combination with REGN2810, and to characterize the PK of REGN2810 in combination with isatuximab. - To assess overall efficacy of isatuximab in combination with REGN2810 or as a single agent.

NCT ID: NCT03367169 Terminated - Fractures Clinical Trials

Surgery of the Pilon Fractures

MICOPIL
Start date: November 23, 2017
Phase: N/A
Study type: Interventional

The assessment consists in comparing the osteosynthesis plate with minimally invasive technique versus open reduction and internal fixation. The aim of study is to compare (period of bandage, efficacy, safety), these two types of surgical technique by using a prospective, randomized analysis.

NCT ID: NCT03364959 Terminated - Asthma in Children Clinical Trials

Ex Vivo Pilot Study of the Impact of Nasal Breathing During the Administration of Inhaled Corticosteroids by Inhalation Chamber in Asthmatic Children Ages Between 1 and 4-year-old

MASQUE
Start date: October 23, 2018
Phase: N/A
Study type: Interventional

The main purpose of this open randomized, ex-vivo comparative study, is to assess and to compare the inhalable dose of inhaled corticosteroid collected through a nasal filter and a mouth filter located in a partitioned face mask and delivered to an infant with asthma via a Tipshaler® holding chamber

NCT ID: NCT03364010 Terminated - Dyslexia Clinical Trials

Dyslexia, Motor Control and Proprioception

Start date: January 4, 2018
Phase: N/A
Study type: Interventional

The investigators hypothesize that children with dyslexia present proprioceptive disorders and the purpose of the present study is to better understand relationships between motor control, proprioception and academic learnings. The investigators compare a group of French students with and without dyslexia aged 10-12.

NCT ID: NCT03363009 Terminated - Surgery Clinical Trials

Contribution of Connected Devices in the Follow-up of the Observance of a Prehabilitation Program

Prehab-Connect
Start date: December 4, 2018
Phase: N/A
Study type: Interventional

Poor physical performance and poor nutritional status increase the risk of complications after major surgery. Prehabilitation is the process of enhancing the functional capacity before surgery. A major problem is the adherence of the patients to the physical program. A controlled randomized study is therefore proposed to determine the impact of coaching on functional exercise capacity. All patients will wear connected devices to measure their physical activity. They will be randomized to either a group in which coaching will be adapted to the physical activity, or a control group in which coaching is performed without any information about physical activity