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NCT ID: NCT04414319 Terminated - SARS-CoV 2 Clinical Trials

Severe Acute Respiratory Syndrome-Coronavirus-2 and Loss of Autonomy in the Elderly

CovAged
Start date: April 15, 2020
Phase:
Study type: Observational

In most diseases, older people have less typical symptomatology than that described for younger people. The investigators therefore hypothesize that within the framework of coronavirus disease 19, the clinical pictures in the elderly will present specificities that will need to be described. Moreover, since infection by the severe acute respiratory syndrome (SARS-CoV-2) virus is new to humans, the investigators do not yet have sufficient information on the fate of the elderly, in terms of loss of autonomy, rehospitalization, institutionalization, mortality, etc. the investigators therefore assume that the clinical pictures in the elderly will present specificities that will need to be described. The investigators hypothesize that an acute infection of this type will have short-, medium-, and long-term repercussions in the elderly.

NCT ID: NCT04414202 Active, not recruiting - Clinical trials for Invasive Breast Cancer

Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis

INTRA-OBS
Start date: December 15, 2009
Phase:
Study type: Observational [Patient Registry]

Due to screening, T1N0 early-stage breast cancer now accounts for more than 50% of the tumors diagnosed in France. The prognosis of these tumors is good, even excellent in women ≥ 65 years of age, with specific survival of 98% at 5 years. The treatment of these tumors combines breast-conserving surgery and external whole breast irradiation for 6.5 weeks. A true de-escalation of treatment is taking place with these tumors, both surgically and medically. Surgery therefore now prefers breast-conserving methods in combination with exeresis of the sentinel lymph node only. In the same way, in many international studies, radiotherapy has been evaluating the possibility of reducing both: - the irradiation volume at the excision site (partial irradiation) - the duration of this irradiation (accelerated radiotherapy) Between 2004 and 2007, the CRLC [Regional Anti-Cancer Center] evaluated the feasibility and the oncological results of intra-operative partial irradiation via a phase II study in women 65 years of age and older with T1N0M0 hormone-sensitive tumors with a good prognosis. From 2010 to 2013, the ICM carried out an observational study of these tumors with an excellent prognosis. In July 2009, the American Society for Radiation Oncology (ASTRO) published a consensus statement with specific recommendations and indications for accelerated partial breast irradiation (APBI). This APBI technique has been developing in France over the past 5 years within the framework of clinical studies and in compliance with the 2012 recommendations of the French National Cancer Institute. This APBI can be given by 3D external radiotherapy or, as in this study, by intra-operative radiotherapy (IORT) in order to obtain optimal precision and spare as much of the surrounding healthy tissue as possible. The Investigator therefore propose a cohort study to prospectively analyze the results of this technique applied to the indications strictly defined by the ASTRO.

NCT ID: NCT04414137 Recruiting - Clinical trials for Bone and Joint Infection

Description of Eosinophilic Pneumonia in BJI/PJI Treated by Daptomycin

Start date: February 19, 2019
Phase:
Study type: Observational

Daptomycin is an antibiotic from the family of cyclic lipopeptides, bactericide, concentration-dependent. Its spectrum concerns Gram-positive bacteria. Since the authorization of daptomycin in 2006, cases of eosinophilic pneumonia and pulmonary eosinophilia associated with its use have been reported in Europe and worldwide. The purpose of this study is to describe the mechanism of occurrence of this AE with dapto; Prolonged exposure and accumulation at the alveolar level could potentially have a role. Better understanding the mechanisms of appearance of this AE would provide predictive elements making it possible to limit the occurrence of this AE in the future

NCT ID: NCT04414059 Completed - SARS-CoV 2 Clinical Trials

Protein Electrophoresis as a Tool for Complications Prediction in COVID-19 Hospitalised Patients

COVELEC
Start date: March 10, 2021
Phase:
Study type: Observational

The inflammation is central in COVID-19 infections. Our aim is to evaluate the clinical value of measuring inflammation by using serum protein electrophoresis (SPE). SPE evaluation of inflammation should be able to predict outcome, follow up evolution or treatment efficacy in patients with coronavirus infection and thus anticipate their evolution to severe viral infection and allow an optimal clinical management. SPE inflammation diagnostics will be benchmarked with other diagnostics of inflammation, currently used more routinely.

NCT ID: NCT04413968 Completed - Covid19 Clinical Trials

COVID-19 Infection and Transmission in Exposed, Confined and Community-based Infants

COVIDOCRECHE
Start date: June 2, 2020
Phase: N/A
Study type: Interventional

According to epidemiological models, the seroprevalence of SARS-CoV-2 infection in Île-de-France as of 11 May was between 10 and 15%. Preliminary data on the number of professionals evicted from nurseries on suspicion of COVID-19 (on clinical grounds) seem to be of the same order of magnitude, but need to be confirmed by a biological technique. Children would be susceptible to infection but often asymptomatic.

NCT ID: NCT04413864 Recruiting - SARS-CoV 2 Clinical Trials

Immunomodulatory Profile of Dexmedetomidine Sedation in Patients Recovering After ARDS Covid-19

DEXDO-COVID
Start date: April 24, 2020
Phase: N/A
Study type: Interventional

Covid-19 infection is due to SARS-CoV-2 member of the Coronavirus family represented by SARS- and MERS-CoVwith neuronal tropism capacity for the brainstem and thalami. Dexmedetomidine has(i) central antihypertensive (ii) sedative and (iii) neuroprotective properties and is often used during patient recovering after mechanical ventilation withdrawal. Dexmedetomidine administration could change the immunomodulatory profile of Covid-19 patients and reduce inflammatory response.CAM-ICU scores and Blood samples from Covid-19 ICU patients will be collected at 4 different timepoints (before Dexmedetomidine administration, at D2, D7 and M6) to analyse the inflammatory profile with different approaches:i) chromatin accessibility, ii) transcriptome analysis, iii) inflammatory cytokines and chemokines levels.

NCT ID: NCT04413838 Not yet recruiting - Clinical trials for Obesity, COVID-19 Infection

Efficiency and Security of NIVOLUMAB Therapy in Obese Individuals With COVID-19(COrona VIrus Disease) Infection

NIVISCO
Start date: June 15, 2020
Phase: Phase 2
Study type: Interventional

Although SARS-CoV-2 (Severe Acute Respiratory Syndrome-associated coronavirus) due to COVID-19 evolves poorly towards ARDS (Acute Respiratory Distress Syndrome) and death, there is to date no validated drug available for severe forms of COVID-19. Patients with COVID-19 undergo a drastic decrease of T lymphocytes (LT) count, while the remaining ones display an "exhausted" phenotype, due to immunosuppressive pathway activation among which the Programed cell Death 1 (PD1) receptor pathways. LT exhaustion is responsible for host anergy towards viral infection and leads to increased risk of severe forms of COVID-19. Moreover, while the number of systemic LT PD1+ correlates with poor prognosis clinical stages of COVID-19 infection, healing from COVID-19 associates with LT PD1 expression normalization. Chinese epidemiologic data identified clinical risk factors of poor clinical evolution (i.e. ARDS or death), among which is found obesity, similarly to observation previously obtained during H1N1 infection (flu virus). Obese persons display meta-inflammation and immune dysfunction, a condition similar to ageing, thus termed "Inflamm-aging", thus also used during obesity. Inflamm-aging, characterized by cytotoxic LT exhaustion and reduced NK cell (Natural Killer cell) cytotoxic function secondary to PD1 pathway activation, could contribute to the poor prognosis observed during cancer and infection in obese individuals. We hypothesize that the immunocompromised profile observed during obesity contribute to their vulnerability towards COVID-19. In cancer or certain infection diseases, NIVOLUMAB, an anti-PD1 monoclonal antibody, restores exhausted LT immunity. We thus hypothesize that NIVOLUMAB-induced immunity normalization could (i) stimulate anti-viral response also during COVID-19 infection and (ii) prevent ARDS development, which has previously been associated with low LT count concomitant with increased inflammatory cytokine production. This randomized controlled therapeutic trial, using an add-on strategy to usual standard of care, aims at demonstrating the efficacy and safety of NIVOLUMAB-induced cytotoxic LT normalization, to improve clinical outcomes in hospitalized COVID-19+ adult obese individuals with low LT, since they are at risk of poor prognosis. We postulate that NIVOLUMAB will increase the number of individuals able to stop oxygen therapy at D15

NCT ID: NCT04413539 Completed - Clinical trials for Sickle-cell Disease (SCD)

Evaluation of Impact of Disease on Quality of Life, Education and Socio-professional Integration of Adults and Parents of Children Living With Sickle- Cell Disease in France

DREPAtient
Start date: June 2, 2020
Phase:
Study type: Observational

Sickle cell disease (SCD) is the most common genetic disease in France. Its consequences on patient's life-course and quality of life need to be precisely identified among French patients and their family to be able to improve patients care according to their specific needs. The aim of the study is to accurately describe the impact of SCD on quality of life of patients living in France, or their family (for minor patients). The consequences of the disease on professional life, education and material condition of patients or their parents will be described by the patients themselves.

NCT ID: NCT04413461 Recruiting - Enuresis, Nocturnal Clinical Trials

Comparative Study of the Efficacy of TENS Versus Placebo in Isolated Primary Enuresis

TENS-Enuresis
Start date: January 13, 2021
Phase: N/A
Study type: Interventional

Nocturnal enuresis is a functional urinary disorder in children. It is intermittent urinary incontinence during sleep in children aged 5 years and older. It is said to be "primary" if the child has never been clean at night for at least 6 months and "isolated" if there are no other associated urinary symptoms, including daytime symptoms. It is a common condition with significant repercussions, including disruption of family and social life and a frequent decline in self-esteem. Without treatment, it can persist into adulthood. All these reasons justify taking care of these children. This is usually based on: The establishment of hygienic-dietetic rules: Regular urination and before sleeping, limitation of fluid intake in the evening. They are systematically implemented, whatever the subsequent management Drug treatments (Desmopressin, oxybutynin). These treatments have an efficiency of 60 to 70% at 6 months post treatment and sometimes have side effects. Non-drug treatments: Night-time "pee stop" alarms. They have an efficiency of around 70%. They are little used because they often wake up the whole family and are not reimbursed by social security. TENS (Transcutaneous Electro Neuro Stimulation) is a neuro-modulation technique which consists of stimulating the nerves by means of skin electrodes in order to obtain a somatic response. In urology, it is mainly used by stimulating either the sacral region, origin of the vesical innervation, or the tibial nerve. Its main indication is overactive bladder, a source of discomfort and incontinence. It is used at home, the side effects are exceptional and it does not disturb the activities of the patients. Few studies have evaluated its effectiveness in isolated primary enuresis.

NCT ID: NCT04413448 Completed - Clinical trials for Rheumatoid Arthritis

Performance of CT Parameters Compared to Bone Mineral Density to Detect Bone Fragility in Rheumatoid Arthritis

Start date: January 1, 2020
Phase:
Study type: Observational

Objective: To evaluate the performance of CT parameters (SBAC-L1 and fractal analysis) compared to BMD (gold standard) to detect vertebral fractures in rheumatoid arthritis