Clinical Trials Logo

Filter by:
NCT ID: NCT03190577 Completed - Clinical trials for Transthyretin Amyloidosis

Assessment of the Prevalence of TTR Amyloid Neuropathy in a Population of Patients With Neuropathy of Unknown Aetiology

PRE-TRANS
Start date: September 21, 2017
Phase: N/A
Study type: Interventional

Familial amyloid neuropathy due to transthyretin gene mutations (TTR-FAP) is a rare autosomal dominant inherited disease resulting in the abnormal multi-system deposition of amyloid proteins. These deposits produce a multi-organ disease. AP is usually fatal 10 to 15 years after onset of symptoms if untreated. The prevalence of the disease remains still poorly understood and usually the search for this pathology is done in a third line of investigation. So the average time to diagnosis is extremely long, from 12 to 24 month. Now that the investigators have etiological treatment ( famidis (Vyndaqel®) and Diflunisal (Dolobid)) of this disease, it is essential to be able to detect FAP patients as early as possible. With this study, investigator decided to test for TTR mutation all patients presented with neuropathy of unknown etiology at the first line of investigation. The goal of this study is to evaluate the prevalence of FAP-TTR among neuropathy and defined the best strategy to test this population for TTR mutations.

NCT ID: NCT03190486 Completed - Clinical trials for Magnetic Resonance Imaging

Perception of Baby's Painful Cry in fMRI

Start date: July 24, 2017
Phase: N/A
Study type: Interventional

Crying is the primary signaling strategy available to the human newborn for eliciting parental care. Yet, the investigators only have superficial understanding of the information carried by cries, and how this information is perceived by parents. Using modern tools of sound processing and functional Magnetic Resonance Imaging (fMRI) experiment, this study aims to investigate cry-induced brain activation in adult depending on the cry's acoustic properties expressing various degrees of stress and distress levels. For that, Adults will be tested inside a fMRI magnet to determine their brain activations elicited by different babies cries according to whether the cry was evoked in a pain situation or not. The cerebral activity will be investigated in relation to acoustic features of cries (e.g. with pitch and/or roughness variations). To test if the gender or parentally of adult listeners influence their perceptions and brain responses, the task will be applied to 2 different groups (men and women not-parents). The hypothesis is that the brain of adult listeners will be able to discriminate adequately the intensity of the pain mediated by the cries. This process should involve brain areas such as the insular and the orbito frontal cortex that are known to participate in the integration of pain intensity and pain controls. The experiment should also determine which one of the acoustic features is able to transmit pain and to recruit brain areas involved in pain processes.

NCT ID: NCT03190031 Completed - Cystic Fibrosis Clinical Trials

Respiratory Muscle Training in CF Patients

MUCOMUREE
Start date: February 1, 2017
Phase: N/A
Study type: Interventional

The present study aims at evaluating the effect of respiratory muscle training in adult patients with cystic fibrosis on lung function, exercise performance and quality of life.

NCT ID: NCT03189875 Completed - Clinical trials for Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE) Prospective Observational Cohort Study (SPOCS)

SPOCS
Start date: June 28, 2017
Phase:
Study type: Observational

SPOCS is an international, multicenter, prospective observational cohort study with bi-annual study visits over a 3-year follow-up designed to systematically describe the comprehensive SLE patient-journey regarding clinical features, disease progression and treatment patterns, SLE outcomes, health status assessments (PROs), and health care resource utilization (HCRU) in a general population of moderate-to-severe SLE patients.

NCT ID: NCT03189719 Completed - Clinical trials for Esophageal Neoplasms

First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590)

Start date: July 25, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus standard of care (SOC) chemotherapy with cisplatin and 5-fluorouracil (5-FU) versus placebo plus SOC chemotherapy with cisplatin and 5-FU as first-line treatment in participants with locally advanced or metastatic esophageal carcinoma. The overall primary efficacy hypotheses are as follows: 1. In participants with esophageal squamous cell carcinoma (ESCC), participants whose tumors are programmed cell death-ligand 1 (PD-L1)-positive (defined as combined positive score [CPS] ≥10), ESCC participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, overall survival (OS) is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy. 2. In participants with ESCC, participants whose tumors are PD-L1 positive (CPS ≥10), and in all participants, progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by investigator is superior with pembrolizumab plus SOC chemotherapy compared with placebo plus SOC chemotherapy.

NCT ID: NCT03189290 Completed - Postoperative Pain Clinical Trials

Study of the QUadratus Lumborum Bloc in Total Hip ARthroplasty: Efficacy and Safety

SQUARE
Start date: July 6, 2017
Phase: N/A
Study type: Interventional

The purpose of this prospective research study is to determine the best way to manage post-operative pain after a total hip arthroplasty. Currently, there is no standard of care for managing post-operative pain in these patients. The quadratus lumborum block (QLB) first described by Blanco in 2007, is a promising technique in this indication: recently, there is a growing evidence for the use of the QLB as an alternative technique for pain management after hip surgery.

NCT ID: NCT03188900 Completed - Preeclampsia Clinical Trials

Blood Collection to Validated New Therapeutics Strategies Against Preeclampsia

APHERESE
Start date: June 12, 2017
Phase:
Study type: Observational [Patient Registry]

The aim of the study is to setup a collection of maternal plasma and serum from patients with preeclampsia and normal pregnancy for in vitro validation of new therapeutics based on extra-corporal removal of sFlt-1

NCT ID: NCT03188666 Completed - Clinical trials for Fibrodysplasia Ossificans Progressiva

A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva

LUMINA-1
Start date: February 26, 2018
Phase: Phase 2
Study type: Interventional

This is a three period study design consisting of a 6-month, randomized, double-blind placebo-controlled treatment (period 1) followed by a 6-month, open-label treatment (period 2) and a follow-up treatment period (period 3). Primary safety objective of the study is to assess the safety and tolerability of REGN2477 in male and female patients with fibrodysplasia ossificans progressiva (FOP). Primary efficacy objective of the study is to assess the effect of REGN2477 versus placebo on the change from baseline in heterotopic ossification (HO) in patients with FOP, as determined by 18-NaF uptake in HO lesions by positron emission tomography (PET) and in total volume of HO lesions by computed tomography (CT). Key Secondary objectives are: - To compare the effect of REGN2477 versus placebo on pain due to FOP, as measured by the area under the curve (AUC) for pain based on daily pain numeric rating scale (NRS) scores - To assess the effect of REGN2477 versus placebo on the change from baseline in HO, as determined by the number of new HO lesions identified by 18F-NaF PET or by CT - To assess the effect of REGN2477 versus placebo on the change from baseline in 18F-NaF standardized uptake value maximum (SUVmax) of individual active HO site(s) by PET - To assess the effect of REGN2477, between week 28 and week 56, on the number, activity, and volume of HO lesions identified by 18F-NaF PET or by CT in patients who switch from placebo to REGN2477 at week 28 versus the same patients between baseline and week 28 - To assess the effect of REGN2477 versus placebo on the change from baseline in biochemical markers of bone formation - To characterize the concentrations of total activin A at baseline and over time following the first dose of study drug - To characterize the concentration-time profile (pharmacokinetics [PK]) of REGN2477 in patients with FOP - To assess the immunogenicity of REGN2477

NCT ID: NCT03188588 Completed - Hypoxemia Clinical Trials

Observance of Long Term Oxygen Therapy in Chronic Inspiratory Disease Patients

ObsO2
Start date: January 2017
Phase:
Study type: Observational

Long-term oxygen therapy (LTOT) is the reference treatment for chronic respiratory failure. This treatment is based on the principle of oxygen supplementation via a source to correct hypoxemia in patients. At present, adherence to this treatment is difficult to evaluate (reporting by patients), but the results of the literature show poor LTOT compliance. It is therefore important to accurately measure the oxygen consumption by patients and to understand the factors explaining LTOT compliance. The ultimate aim is to improve our patient management to make them more observant in order to improve the therapeutic efficacy of the treatment.

NCT ID: NCT03187743 Completed - Clinical trials for Lupus Erythematosus, Systemic

Personalised Pharmacological Approach to the Tapering of Corticosteroid Doses in Systemic Lupus Patients Treated With Prednisone

DECOR
Start date: April 17, 2018
Phase: N/A
Study type: Interventional

This research study is a multicentre prospective pharmacokinetic study. The clinical and biological data will be collected in the framework of a prospective study. The drug to be evaluated is a glucocorticoid routinely used to treat Systemic lupus erythematosus (SLE) patient. Initial dose of prednisone must be oral and at least 0.5mg/Kg/day, but the precise dosage and the tapering regimen will be determined according to the clinical judgment of the investigator. The duration of the research period for each patient will be 3 months. Three visits (which are all usual care visits) will be needed within the 3 months of the study for collecting data and/or blood sampling