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NCT ID: NCT03619044 Terminated - Clinical trials for HER2-positive Breast Cancer

The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane.

REVER
Start date: August 28, 2020
Phase: N/A
Study type: Interventional

This is an exploratory, prospective and multicentric study aiming to highlight by FES-PET imaging that an anti-HER2 treatment by trastuzumab + pertuzumab can reverse the ERα status in patients with metastatic breast cancer HER2 + and ERα neg. For each included patient, 2 FES-PET Imaging will be performed for the study (before cancer treatment initiation and before the cycle 3 of treatment) at the IUCT-O center (Institut Universitaire du Cancer de Toulouse). Treatment (trastuzumab + pertuzumab + taxane) will be administered according to the current recommendations in each participant center. Patients will be followed during the 3 cycles of treatment.

NCT ID: NCT03618212 Terminated - Myeloma Clinical Trials

MRI in Multiple Myeloma: Analysis of the Axial Skeleton Versus Whole Body. What is the Required Analysis?

MYMO
Start date: December 21, 2018
Phase:
Study type: Observational

The investigators wish to determine which anatomic regions need to be explored in order to correctly diagnose myeloma: whether axial skeletal MRI alone is sufficient or whether it is necessary to perform a total skeletal MRI.

NCT ID: NCT03614507 Terminated - Bronchiolitis Clinical Trials

Automation Oxygen Flow Titration in Spontaneously Breathing Infants

Start date: October 9, 2018
Phase: N/A
Study type: Interventional

The objective of this study is to assess the efficacy of the FreeO2 device in shortening the hospital length of stay during a first episode of hypoxemic bronchiolitis in infants less than 1 year of age. FreeO2Bronchio study is a multicenter, prospective, controlled, randomized, open-label study.

NCT ID: NCT03608137 Terminated - Schizophrenia Clinical Trials

Cannabis and Thought Disorder in Schizophrenia

CANDI
Start date: December 7, 2018
Phase: N/A
Study type: Interventional

Recent studies have suggested a strong relationship between cannabis use and the level of thought disorder in subjects with schizophrenia. Moreover, the level of thought disorder has been associated with an increased functional connectivity between the temporal lobe and the Putamen. However, the brain mechanisms underlying these two relationships are still poorly known. Better understanding these mechanisms is important to improve patients' care, in particular among treatment-resistant patients. The objective of the CANDI study consists of assessing whether the level of cannabis use in patients with schizophrenia modulates the level of thought disorder via a modulation of the functional connectivity between the temporal lobe and the Putamen. Analyses will be controlled for the composition of cannabis, in particular the tetrahydrocannabinol / cannabidiol ratio.

NCT ID: NCT03605329 Terminated - Clinical trials for Diabetes Mellitus, Type 1

Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS

DIADYSAS
Start date: September 5, 2018
Phase: N/A
Study type: Interventional

The links between obstructive sleep apnea syndrome (OSAS) and type 1 diabetes (T1D) are poorly studied. This study proposes to evaluate the severity of cardiovascular autonomic neuropathy (CAN) related to T1D in case of associated OSAS. This issue has significant diagnostic and therapeutic implications because of the increased cardiovascular risk in case of confirmed CAN in T1D patients.

NCT ID: NCT03605069 Terminated - Clinical trials for Epidermolysis Bullosa Dystrophica, Recessive

A Double-blind, Randomized, Intra-subject Placebo-controlled, Multicenter, Multiple Dose Study, Evaluating Safety, Proof of Mechanism, Preliminary Efficacy and Systemic Exposure in Subjects With Confirmed DDEB or RDEB Diagnosis With One or More Pathogenic Mutations in Exon 73 in the COL7A1 Gene

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

A double-blind, randomized, intra-subject placebo-controlled, multicenter, multiple dose study, evaluating safety, proof of mechanism, preliminary efficacy and systemic exposure in subjects with confirmed DDEB or RDEB diagnosis with one or more pathogenic mutations in exon 73 in the COL7A1 gene.

NCT ID: NCT03603587 Terminated - Skin Cancer Clinical Trials

Bioclinical Study of Scalp Photoaging of a Population Male Over 65 Years Old.

BACCHUS
Start date: February 14, 2019
Phase: N/A
Study type: Interventional

The aging of skin, especially that of the scalp, is a combination of intrinsic and extrinsic aging factors secondary to the chronic sun exposure. For men with an alopecia genetic (= bald men), the solar part, in skin aging process, is major. The helio-dermal scalp is frequently the site of cancers mainly after 65 years. Objectives are to identify specific biomarkers involved in the photo-aging of the alopecic scalp

NCT ID: NCT03603288 Terminated - Clinical trials for Duchenne Muscular Dystrophy

Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E)

SIDEROS-E
Start date: July 4, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the long-term safety and efficacy of idebenone in patients with Duchenne muscular dystrophy (DMD) who completed the SIDEROS study.

NCT ID: NCT03600818 Terminated - Clinical trials for Polymyalgia Rheumatica

Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica

Start date: October 9, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of KEVZARA (sarilumab) in participants with polymyalgia rheumatica (PMR) as assessed by the proportion of participants with sustained remission for sarilumab with a shorter corticosteroid (CS) tapering regimen as compared to placebo with a longer CS tapering regimen. Secondary Objectives: - To demonstrate the efficacy of sarilumab in participants with PMR compared to placebo, in combination with a CS taper with regards to: - Clinical responses (such as components of sustained remission, disease remission rates, time to first disease flare) over time. - Cumulative CS (including prednisone) exposure. - To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with PMR. - To measure sarilumab serum concentrations in participants with PMR. - To assess the effect of sarilumab in reducing glucocorticoid toxicity as measured by the composite glucocorticoid toxicity index (GTI) questionnaire.

NCT ID: NCT03600805 Terminated - Clinical trials for Giant Cell Arteritis

Evaluation of Efficacy and Safety of Sarilumab in Patients With GCA

Start date: November 20, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of sarilumab in participants with giant cell arteritis (GCA) as assessed by the proportion of participants with sustained remission for sarilumab compared to placebo, in combination with a corticosteroid (CS) tapering course. Secondary Objective: - To demonstrate the efficacy of sarilumab in participants with GCA compared to placebo, in combination with CS taper with regards to: - Clinical responses (such as responses based on disease remission rates, time to first disease flare) over time. - Cumulative CS (including prednisone) exposure. - To assess the safety (including immunogenicity) and tolerability of sarilumab in participants with GCA. - To measure sarilumab serum concentrations in participants with GCA. - To assess the effect of sarilumab on sparing glucocorticoid toxicity as measured by glucocorticoid toxicity index (GTI).