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NCT ID: NCT04171674 Not yet recruiting - Pneumonia Clinical Trials

Pharmacokinetics of High-dose Ceftobiprole in Community-acquired Pneumonia Under Mechanical Ventilation.

PAC CEF
Start date: September 2021
Phase: N/A
Study type: Interventional

The main aim of the study is to describe plasma pharmacokinetics (PK) and pulmonary diffusion of high-dose ceftobiprole (500 mg loading dose followed by 2.5 g under continuous infusion for 24h) for mechanically-ventilated adult patients with severe community-acquired pneumonia, using population PK modelling. The secondary aims are : A- To determine whether the pharmacokinetic / pharmacodynamic (PK/PD) targets can be achieved in the plasma and epithelial lining fluid with the recommended doses of ceftobiprole. B- To define the optimal dose regimen for ceftobiprole in this population. C- To evaluate clinical recovery (at Day 3 and Day 8) and microbiological recovery (at Day 3). D- To evaluate the clinical evolution. E- To evaluate the clinical and biological tolerance.

NCT ID: NCT04170881 Not yet recruiting - Respiratory Health Clinical Trials

CRESPI - Respiratory Health of Children in Daycare

CRESPI
Start date: November 19, 2019
Phase:
Study type: Observational

CRESPI - RESPIratory health of Children in daycare The CRESPI study, will be a cohort of 1500/2000 children attending daycare in Paris region, and will be initiated in November 2019. The aim of the project is to study the impact of environmental exposures to cleaning products and disinfectants on respiratory health of infants and toddlers (< 3 years) in daycares Two specific aims were defined: 1. evaluate environmental exposure to cleaning products by complementary and innovative tools: air quality measurements in daycares, specific standardized questionnaire, identification of compounds of the products via a database and a Smartphone application to scan bar codes and inform on product use 2. evaluate the impact of early exposure in daycares and at home on respiratory health of young children

NCT ID: NCT04170218 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Quality of Care for Knee and Hip Osteoarthritis in Elderly Patients

QSAMISA
Start date: December 1, 2019
Phase:
Study type: Observational

Introduction: Hip and knee osteoarthritis (OA) was ranked in 2010 as the eleventh highest contributor to global disability. In France in 2014, non-spinal OA was the leading self-reported cause of morbidity among adults over sixty-five years of age, with a prevalence of 49.5 per cent. OA is known to be the first cause of disability in activities of daily life and a risk factor of frailty among people over seventy-five years of age. Despite its major impact on the elderly population's quality of life and health, quality of care for OA in elderly patients remains understudied. Objective: The study aims to assess the quality of care for knee and hip OA in patients aged 75 years and over.

NCT ID: NCT04170205 Not yet recruiting - Clinical trials for Small Fiber Neuropathy

Causes Associated With Small Fiber Neuropathy (SFN).

EtioNPF
Start date: November 15, 2019
Phase:
Study type: Observational

Small fiber neuropathy (SFN) is an injury of cutaneous nerve fibers, mainly by a decrease in their density within the cutaneous tissue. The symptomatology associated with this SFN is broad with symptoms that are essentially sensory, but also autonomic. The etiologies of SFN are numerous (diabetes, drug, infectious, immunological...) and clinically non-specific, justifying a broad etiological assessment. The appearance of staged skin biopsies in the SFN balance sheet has greatly helped to improve diagnosis. Despite this, a significant part of SFN remains without associated etiology and is considered idiopathic. As the distribution of the different causes of SFN remains a missing data to date, the completion of this cohort study by one of the SFN reference centres should make it possible to establish the prevalence of SFN causes over a large population. Only patients with clinical symptoms that may be related to SFN and who have been sampled for SFN, positive or not, will be eligible for recruitment. The result of the anatomopathological sampling will allow patients to be separated into two groups, with or without SFN. The main judgement criteria will be the prevalence of etiologies associated with SFN: diabetes, medication, systemic lupus erythematosus, Gougerot-Sjögren syndrome, amylosis, dysthyroidism, alcoholism, vitamin B12 deficiency, HIV infection, hepatitis C, paraneoplastic syndrome, hereditary disease (Fabry disease, Friedreich ataxia,...), idiopathic, others.

NCT ID: NCT04168788 Not yet recruiting - Clinical trials for Acute Lymphoblastic Leukemia

Pharmacogenetic Study of Antimitotic Therapies Involved in Hepatic VOD in Children With Nephroblastoma or ALL

MVO
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Hepatic veno-occlusive diseases (VOD) during cancer treatment in children are serious toxicities that have occurred with interruptions of chemotherapy and risk of relapse. In addition, these toxicities have a negative impact on the patient's quality of life, serious long-term sequelae and are potentially fatal in children. The risk factors associated with the occurrence of these complications are, to date, unknown, at the exception to the exposition to certain treatments (6-thioguanine, busulfan, actinomycin D, radiotherapy, etc.). To understand the effects of this toxicity and those of susceptibility to the disease becomes a major issue in the treatment of these children.

NCT ID: NCT04168047 Not yet recruiting - Clinical trials for Irritable Bowel Syndrome

Are Sleeping Disorders Associated With Visceral Hypersensitivity in Irritable Bowel Syndrome Patients ?

S3i
Start date: July 2020
Phase: N/A
Study type: Interventional

Visceral hypersensitivity is frequent in IBS population up to 60% and is correlated with severity and altered quality of life. Sleeping troubles are most frequent in IBS population. Insomnia is a frequent disorder with an important cost for healthcare. Insomnia could decrease pain threshold. Visceral hypersensitivity was never measure in patients with insomnia. The hypothesis is IBS patients with insomnia probably have lower visceral pain threshold. The objective is to assess pain threshold during a barostat procedure in in IBS patients with or without insomnia in comparison with healthy volunteers or patients with insomnia. If the hypothesis are confirmed, insomnia should be look at in IBS patients and its treatments could improve visceral hypersensitivity and IBS symptoms.

NCT ID: NCT04167046 Not yet recruiting - Thoracic Surgery Clinical Trials

Erector Spinae Block in First Rib Resection: a Monocentric Before-after Study

MERCOTE
Start date: November 2019
Phase:
Study type: Observational

First rib resection surgery for thoracic outlet syndrome is associated with an intense postoperative pain. It leads to significant consumption of nonsteroidal anti-inflammatory drugs and opioids, and hospitalization for several days. In our center, first rib resection surgery was usually performed under general anesthesia combined with diffuse local infiltration of the axillary fossa. Erector spinae block is an interfascial block where a local anesthetic is injected between the erector spinae muscle and the transverse process, in order to obtain a multimetameric analgesia. It has now shown its efficacy and its safety in thoracic and abdominal surgeries by decreasing the morphine consumption and pain scores. Since November 2018, this erector spinae block is systematically performed preoperatively for first rib resection in our center, in association with a general anesthesia. Patient satisfaction seems important but remains to be assessed objectively. In a before-after study, our goal is to assess the impact of the use of erector spinae block on postoperative pain in the first rib resection surgery.

NCT ID: NCT04166110 Not yet recruiting - Clinical trials for Community-Acquired Pneumonia

Antibiotic Therapy In Respiratory Tract Infections

AIR
Start date: September 2023
Phase: N/A
Study type: Interventional

Primary aim: to demonstrate that stopping antibiotic treatment in patients diagnosed with acute community acquired pneumonia (CAP) based on clinical response has a non-inferior efficacy 15 days after start of treatment, compared to a conventional predetermined duration left to the physician's judgement, in adults treated in the community setting. Secondary aims: To compare the 2 study arms on: 1. Clinical success at late follow up (Day 30), 2. Duration of antibiotic treatment, 3. Frequency and severity of adverse events, 4. Patient's pneumonia symptoms and quality of life.

NCT ID: NCT04164576 Not yet recruiting - Graft Rejection Clinical Trials

Study of the Pathogenicity and Humoral Immune Response Induced by BK Virus in Lung Transplant Recipients

BKV-Pneumo
Start date: January 2020
Phase:
Study type: Observational

BK virus (BKV) is a ubiquitous virus that infects more than 80% of the population. In case of immunosuppression, BKV can replicate and induce nephropathies in renal transplant recipients or haemorrhagic cystitis in bone marrow transplant recipients. The disruption of the balance between BKV replication and immune control is considered the key element in the development of these pathologies. During lung transplantation, patients undergo intense immunosuppression that favors the reactivation of persistent viruses such as EBV, CMV and probably BKV. Although the data on EBV and CMV reactivation are very clear and allow optimal management, the prevalence of BKV replication and its clinical impact in lung transplant recipients remains unknown at this time. The aim of this study is to know the incidence and clinical impact of BKV replication in lung transplant recipients. Moreover, the results will help to better understand the interaction between the virus and his host, with a focus on the humoral and cellular immune response against BKV. The results could possibly enable to define predictive markers of BKV replication and of its evolution.

NCT ID: NCT04160364 Not yet recruiting - Gender Dysphoria Clinical Trials

Gender Dysphoria in Children and Adolescents : Parents' Perspectives

GeDyPar
Start date: October 2020
Phase:
Study type: Observational

Gender dysphoria is defined as a persistent incongruence between an experienced gender and the assigned sex at birth Transgender and gender nonconforming persons desire to modify their appearance to be consistent with their self-identified gender identities. In non-binary people, contrary to binary transgender persons, self-identified gender identities do not fit the classical pattern male/female. During the last decennium, an increase in the number of young subjects, especially children and adolescents, referred to gender identity centres has been observed. A new nosological entity "rapid-onset gender dysphoria in adolescents and young adults" has recently been described in the literature, whose etiology has not been well understood. This growing demand of adolescents and young adults observed in the recent years is not well understood.