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NCT ID: NCT04670536 Active, not recruiting - Spinal Deformity Clinical Trials

The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems (PASS DEGEN)

PASS DEGEN
Start date: May 17, 2018
Phase:
Study type: Observational

The purpose of this post-market clinical study is to evaluate the long-term safety and efficacy of the MEDICREA's systems PASS LP, PASS DEGEN, and PASS Tulip PRIME to treat degenerative diseases. This study is supporting the clinical evaluation report. From the standard-of-care perspective, the results of The Degen study are expected to contribute to a better understanding of expected safety and clinical outcomes from a short (intra- and peri-operative) to a medium-term follow-up (post-operatively).

NCT ID: NCT04670224 Recruiting - Analgesia Clinical Trials

Efficiency of the Quadratus Lumborum Block for Post-operative Analgesia in Abdominoplasty Surgery

QLB
Start date: March 16, 2021
Phase: N/A
Study type: Interventional

Abdominoplasty is a common surgical procedure in plastic surgery which causes postoperative pain and may delay patients' recovery. Surgery is potentially associated with a number of postoperative complications, whether cardiovascular, respiratory, infectious, thromboembolic, or digestive … Although they do not inevitably lead to a life-threatening prognosis, in many cases these complications delay post-operative recovery. Defined in the 1990s by Professor Henry Kehlet's Danish team, rapid rehabilitation after planned surgery is an approach to overall patient care that aims to rapidly restore previous physical and mental capacities and thus significantly reduce mortality and morbidity. Pain management is at the heart of this program and local anesthesia techniques are at the heart of early rehabilitation programs. Described for just over a decade, Quadratus Lumborum Block (QLB) have shown their effectiveness for analgesia in abdominal, or orthopedic, or obstetrical surgery. Considering the anatomical territory concerned, this locoregional anesthesia technique seems to be very interesting in abdominoplasty to allow early rehabilitation of the patient.

NCT ID: NCT04670172 Recruiting - Clinical trials for Chronic Rhinosinusitis (Diagnosis)

Real-Life Chronic Rhinosinusitis Outcome Registry

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

An international consortium of leading medical experts in the field of chronic respiratory disease, the research team of Galenus Health and the non-profit organization EUFOREA (European Forum for Research and Education in Allergy and Airway diseases) has been conceived to conduct real-life outcome research. The Galenus Health digital platform consisting of a mobile application for patients and an online dashboard for physicians will be implemented in each of the participating centres. The data will be centralized in a pseudonymized database and will be the basis of the Chronic RhinoSinusitis Outcome Registry.

NCT ID: NCT04670029 Recruiting - Clinical trials for Diffuse Large B Cell Lymphoma

Impact of an APA Program on EFS in Patients With Diffuse Large-cell B Lymphoma Treated in 1st Line

PHARAOM
Start date: September 8, 2021
Phase: Phase 3
Study type: Interventional

Diffuse large B cell lymphoma is the most common histology of non-Hodgkin's malignant lymphomas (31% of lymphomas), with an incidence of between 15 and 20 new cases per year per 100,000 inhabitants in France. The median age is 65 and a third of patients are over 75 years old. 60% of patients are cured after a standard regimen of chemotherapy with RCHOP; 40% of patients will, however, relapse. No other regimen has shown improvement in overall survival, but poor prognosis factors have been identified. Beyond these factors, other prognostic factors can impact overall and progression-free survival: sarcopenia, nutritional status disorders Sarcopenia is defined by the reduction of muscle mass and strength. It was first described in the elderly and classified as geriatric syndrome such as dementia, falls or frailty. It varies from 5 to 13% between 60 and 70 years and between 11 and 50% beyond 80 years and is classified as primitive, that is to say related to age It can however be secondary to neoplasia. This event has been described in patients with hematologic malignancies during chemotherapy and can reach 55% of patients in the elderly. It is proportional to the intensity of the treatments. It emerges as an independent prognostic factor which is detrimental to survival in these patients. Physical exercise combined with nutritional support could reduce it. The positive impact of adapted physical activity has been shown in numerous publications on reducing the incidence and risk of relapse for certain cancers (breast, colon prostate). It is less obvious in hematology in view of studies published on adapted physical activity . Adapted physical activity seems to provide a survival benefit in diffuse large cell B lymphoma however the number remains too low in this histology. Sarcopenia is an often-underestimated event and is associated with older age, co-morbidities, increased infectious complications, and early mortality. Correcting sarcopenia through appropriate physical activity could reduce its negative prognostic impact. The aim of the study is to increase the event-free survival of patients in the RCHOP and adapted physical activity arm by 15% compared to the standard arm.

NCT ID: NCT04670003 Completed - Covid19 Clinical Trials

Spread Analysis of COVID-19 Outbreak in France by Self-assessment Web-application

SourceCOVID
Start date: January 2, 2021
Phase:
Study type: Observational [Patient Registry]

A coronavirus pandemic began on 12/31/2019 with a first Chinese patient. As of 04/04/2020, the epidemic affects more than 190 countries with more than 50 million official contaminations and 1,251,000 deaths. (Univ J Hopkins). This virus causes a pathology ranging from simple flu-like symptoms in 80% of cases to acute respiratory distress syndromes requiring intensive care in 5% of cases and a death rate of 1.4 to 4% of cases. Viral contamination is airborne and fecal A first epidemic wave crossed France in March / April 2020 then a second in October / November with a source of contamination which began in mid-August 2020. The sources of propagation are not well known (what places, what times, what contacts…? ) In the context of the health crisis linked to the coronavirus, knowledge of the sources of propagation of this 2nd wave is an important issue to guide end of lockdown and second lockdown policies.

NCT ID: NCT04669938 Recruiting - Covid19 Clinical Trials

Role of the Microbiota in the Evolution of the SARS-CoV-2 Disease,COVID-19, in Hospitalized Patients

MicrobioCOVID
Start date: December 4, 2020
Phase:
Study type: Observational

Patients hospitalized for COVID-19 may need intensive care (e.g. mechanical ventilation) during hospitalization. Some risk factors are already known but better targeting of such patients is still needed, at least because existing risk factors are not strong enough to provide an accurate prediction. Care organization would benefit for such a predictive tool. Oropharyngeal and gut microbiota could potentially fill a significant gap in predictive performances. The investigators therefore propose to sample 200 patients (oropharyngeal and rectal swab) admitted in infectious disease department at Bichat Hospital and at high risk of needing intensive care during hospitalization. The investigators plan to perform metagenomic sequencing and bioinformatic analysis of these samples to characterize the diversity of bacterial species present in the oropharynx and the gut and to identify new factors associated with the need for intensive care. Aside metagenomic analyses, The investigators will perform semi-quantitative cultures of the oropharyngeal and gut microbiota to identify and quantify pathogens in order to predict the risk of bacterial infections in COVD-19 patients. For patients transferred in intensive care unit, The investigators will to perform another series of samples to better characterize the evolution of microbiota during mechanical ventilation and identify factors associated with the risk of developing a ventilator-associated pneumonia. Microbiota data will be considered together with the host genotype, the viral sequence and a deep immunological profiling to identify the main determinants of the evolution toward severity of COVID-19.

NCT ID: NCT04669912 Completed - Type 1 Diabetes Clinical Trials

COVID-19 Pandemic Lockdown Effect in Adolescents and Young Adults With Type 1 Diabetes: Positive Results of an Unpreceded Challenge for Telemedicine and Patient Self-management

COVIDIABADO
Start date: January 15, 2021
Phase:
Study type: Observational

Lockdown resulting from the COVID-19 pandemic was an unpreceded model of the impact of lifestyle on chronic diseases, especially for adolescents and young adults with type 1 diabetes (T1D) whose lifestyle is known to strongly impact disease management. The investigators aimed to assess changes in self-monitoring and glycemic control in this population before, during, and after the two-month French lockdown. Te investigators hypothesized an improvement in glucose control and glucose sensor usage. The protocol will include all patients with T1D from 13 to 25 years old using a flash glucose monitoring related to the LibreView cloud platform. The primary outcome, evolution of percentage of glucose time in range 70-180 mg/dL (TIR), and secondary outcomes (glucose management indicator GMI, time spent below range TBR, and sensor usage) will be analyzed with a linear mixed-effects regression model.

NCT ID: NCT04669067 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

TL-895 and KRT-232 Study in Acute Myeloid Leukemia

Start date: March 31, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates TL-895, a potent, orally available and highly selective irreversible tyrosine kinase inhibitor combined with navtemadlin (KRT-232), a novel oral small molecule inhibitor of MDM2 for the treatment of adults with FLT3 mutated Acute Myeloid Leukemia. Participants must be relapsed/refractory (e.g., having failed prior therapy) to be eligible for this study.

NCT ID: NCT04669054 Completed - Depression Clinical Trials

Hospital Interns Psychological State During the COVID-19

RESICOV
Start date: December 1, 2020
Phase:
Study type: Observational

The mental health of the French population in response to covid-19 pandemic is of concern. Health professionals are prone to more mental disorders due to their direct exposure to the pandemic consequences. Indeed, compared to general population, health care workers face enormous in the current health situation, especially those who may be in contact with suspected or confirmed cases (risk of infection, inadequate protection, loss of control, lack of experience in managing the diseases, overwork, stigma, lack of support). Thus, it seems interesting to describe the psychological state of hospital interns during this pandemic.

NCT ID: NCT04668937 Completed - Clinical trials for Reason for Consultation

Conséquences of the COVID-19 Lockdown Measures on the CHRU Nancy Pediatric Emergency Services

Start date: March 18, 2020
Phase:
Study type: Observational

The first period of COVID 19 Lockdown Measures (From 18 March to 11 may 2020) change the French people way of life and their medicine knowledges. A study which evaluates the Nancy's Pediatric emergencies population utilization during this time could detect pathological changes. The medical impact of Home Confinement will show an increase (trauma, maltreatment) or decrease (virus disease) of several pathology. The study aims to help clinicians to the children care if another time of Home Confinement happened. The main objective is to evaluate the behavioural changes and the reason consultation in Nancy's Pediatric Emergencies from 18 March to 30 June 2020 comparate to the same time in 2019. We will continue the search after the end of Home Confinement until 30 June 2020 to evaluate what happened just after.