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NCT ID: NCT05387954 Not yet recruiting - Clinical trials for Patent Foramen Ovale

PFO Closure, Oral Anticoagulants or Antiplatelet Therapy After PFO-associated Stroke in Patients Aged 60 to 80 Years

CLOSE-2
Start date: June 1, 2022
Phase: Phase 3
Study type: Interventional

To assess whether PFO closure plus antiplatelet therapy is superior to antiplatelet therapy alone and whether oral anticoagulant therapy is superior to antiplatelet therapy to prevent stroke recurrence in patients aged 60 to 80 years with a PFO with large shunt (> 20 microbubbles) or a PFO associated with an ASA (> 10 mm), and an otherwise unexplained ischemic stroke.

NCT ID: NCT05387694 Not yet recruiting - Knee Prosthesis Clinical Trials

Study of the Prognostic Value of the Coagulolytic Balance Dependent on Circulating Microvesicles in the Occurrence of Thrombotic Events After Total Knee Replacement in Orthopedic Surgery.

MOTiVE
Start date: June 2023
Phase: N/A
Study type: Interventional

This is a prospective multicenter cohort study to evaluate the prognostic value of new biological markers in predicting thrombotic events after orthopedic surgery. According to the inclusion and non-inclusion criteria below, the study will include 387 major subjects who will undergo first-line total knee replacement and will receive the same standard prophylactic treatment: anticoagulation with Lovenox® (enoxaparin) 4000 IU/d subcutaneously 6 to 8 hours postoperatively and then daily for 15 days in combination with compression stockings.

NCT ID: NCT05386303 Not yet recruiting - Critical Care Clinical Trials

Quantitative Pupillometry

HYDRO-NiP
Start date: May 31, 2022
Phase:
Study type: Observational

The aim of this study is to assess the diagnostic ability of quantitative pupillometry for the early detection of hydrocephalus during the weaning process of the external ventricular drain.

NCT ID: NCT05384392 Not yet recruiting - Clinical trials for First-episode Psychosis

Biomarkers Predictive of Thymic Evolution and Therapeutic Response at 2 Years in Patients With a First Psychotic Episode

PEPAMARKER
Start date: March 2024
Phase: N/A
Study type: Interventional

Psychosis is a severe, common, and disabling psychological disorder. An epidemiological study conducted in England reported an incidence of 34 new cases per 100,000 person-years, with a peak between 16 and 19 years of age. Following a first psychotic episode, two clinical evolutions are possible: thymic psychosis (17%) and non thymic psychosis (83%). The first includes bipolar disorders with a psychotic component and major depressive disorders with a psychotic component; the second, other psychotic disorders, mainly schizophrenia. One of the major difficulties encountered is the frequent impossibility of specifying the type of psychosis at the beginning of the psychotic episode. However, these disorders require different therapies, particularly medication. This leads to a delay in diagnosis with a high risk of relapse. The semiological study of these diseases being carried out within the framework of interviews, it seems interesting to be able to record these and to obtain a quantitative and objective measurement through the study of language. The use of machine learning has made it possible to distinguish patients with schizophrenia from those with bipolar disorder by graphical analysis of language in a more efficient way than with clinical scales.Moreover, it is possible to identify linguistic markers: thus, an alteration of syntactic structures and prosody would be more present in non-thymic than in thymic psychoses. Paraclinical markers are also emerging. In particular, the link between inflammation and mental disorders.For example, an increase in IL-8 has been found only in thymic psychoses. At the radiological level, distinct changes in the volume of grey matter have been shown between thymic and nonthymic psychoses. In this context, it seems essential to be able to distinguish these disorders as early as possible through the combined use of clinical and paraclinical markers, and to be able to better understand their pathophysiology.

NCT ID: NCT05383235 Not yet recruiting - Child Sexual Abuse Clinical Trials

Facial Emotion Recognition in Patients Who Committed Sexual Assault Against Children: an EEG Study

EMOREC
Start date: May 20, 2022
Phase: N/A
Study type: Interventional

This study aims to compare the emotional processing in sexual offenders against children versus healthy volunteers using an objective electrophysiological measurement (EEG) during a facial emotion stimuli presentation task. Secondary goal is to assess emotion recognition performances in this population and evaluate the impact of various factors on these performances (type of emotion, age and sex of person expressing the emotion, neuropsychological and cognitive abilities of the subjects).

NCT ID: NCT05381883 Not yet recruiting - COVID-19 Pandemic Clinical Trials

Mental Health of Professionals of the Silver Economy of New Aquitaine : Online Survey of Accommodation Establishments for Old People and Home Assistance Establishments

SILVER NA
Start date: September 15, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is identify the psychological impact of the coronavirus-19 pandemic on professionals in residential care facilities for old people and home help professionals in New-Aquitaine by : 1. Large-scale screening for the prevalence of mental health disorders among staff. 2. Identification of vulnerability and resilience factors. 3. Improving access to early care for affected professionals.

NCT ID: NCT05380310 Not yet recruiting - Medical Device Clinical Trials

Impact on the Time to Diagnosis of Serious Postoperative Complications by a Controlled Connected Medical Device

SMARTANGEL
Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Post-operative mortality in case of scheduled surgery is 3% in France (Lancet 2013) mainly due to cardiovascular or respiratory complications, by decompensation of pre-existing pathologies. Complications due to the medical practice are the third cause of morbidity (BMJ, 2016). More than half are preventable and are mainly observed in surgical patients. In conventional hospitalization, excluding intensive care, monitoring is done discontinuously for most of the patients, which does not allow early diagnosis of a vital cardiovascular or respiratory failure. Diagnosis and late treatment do not allow good recovery. The early identification of a vital failure by the continuous monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) would allow faster management by the hospital staff and a reduction in immediate and possibly delayed postoperative mortality.

NCT ID: NCT05378815 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Platelet-rich Plasma in Symptomatic Knee Osteoarthritis

PIKOA
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

Intro: Platelet rich plasma (PRP) is largely used in various musculoskeletal disorders such as chronic tendinopathies but also osteoarthritis (OA). Several therapeutic trials evaluating the effectiveness of intra-articular PRP injections in knee OA as well as meta-analyses have already been published. Most of them have compared PRP to Hyaluronic Acid (HA). Their design was very heterogeneous in terms of PRP characteristics and injection protocol. Moreover, the number of patients included was often very low. Only few studies have compared PRP to placebo (physiological serum) and presented the same methodological limitations (limited number of patients, heterogeneous protocols in terms of number and frequency of injections, characteristics of PRP, etc.). Given the insufficient level of evidence related to these limitations, PRP injections are not recommended in the treatment of symptomatic knee OA by the main scientific societies such as American College of Rheumatology (ACR), Osteoarthritis Research Society International (OARSI), American Academy of Orthopedic Surgeons (AAOS) and French Society of Rheumatology (SFR). Experts in the field agree on the need for a placebo-controlled trial with hihg methodological quality and simple design in order to conclude with a good level of evidence to the benefit or not of this new therapeutic weapon in symptomatic knee osteoarthritis of moderate radiographic severity.

NCT ID: NCT05375864 Not yet recruiting - Severe Influenza Clinical Trials

Early Oseltamivir Carboxylate Low Plasma Concentration in Patients Admitted to Intensive Care for Severe Influenza

OPTIFLU
Start date: December 1, 2022
Phase: N/A
Study type: Interventional

Introduction Pandemic and seasonal influenza epidemics can be associated with a high degree of morbidity and mortality, especially in patients developing severe influenza pneumonitis with the acute respiratory distress syndrome (ARDS) or the less frequent fulminant myocarditis. Early administration (i.e. in the first 48 hours) of the neuraminidase inhibitor oseltamivir is associated with reduced mortality in patients hospitalized for severe influenza. Early oseltamivir administration, which can only be given orally (or through a nasogastric tube), is thus recommended by the World Health Organization in patients hospitalized for severe influenza, including those requiring intensive care (ICU) admission. However, enteric absorption may be compromised in critically ill patients due to impaired gut function. Hypothesis/Objective The hypothese is that, in patients admitted for severe influenza, early (i.e., measured at the 48th hour of treatment initiation) oseltamivir carboxylate (OC) low plasma concentration would be: 1) associated with a poor prognosis; and 2) detectable by carrying out a paracetamol absorption test (PAT). The main objective of the study is to determine the prognostic impact of early OC low plasma concentration in patients admitted to the intensive care unit (ICU) for severe influenza. Primary outcome measure: Number of live ventilator-free days at 28-day in patients with versus without OC low plasma concentration.

NCT ID: NCT05375227 Not yet recruiting - Gingival Abrasion Clinical Trials

Assessment of a Sonic Toothbrush on the Abrasion of the Gingival Tissue

ASTA
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

This is a randomized, monocentric, examiner-blind, two-arm, parallel, controlled clinical research study. It aims to assess gingival abrasion by the comparison of pre- to- post-brushing after a single brushing and after 12 weeks of daily home brushing using a macro-relief scoring based on photographs of the gingiva. The study also aims to assess plaque removal, gingival inflammation, gingival recession and gingival color after 12 weeks. To enter the study, adult male and female subjects attending the service of odontology at Rothschild hospital (Paris, France) will refrain from all oral hygiene procedures for 24 hours. Subjects will have the study procedure explained to them both orally and by written instructions. Eligible patients will give their written consent to participate before being included into the study. Following a baseline clinical examination for collection of the following periodontal parameters: plaque control record (PCR), bleeding on probing (BOP), gingival recession (REC), and probing pocket depths (PD), the subjects will be randomized into two balanced groups, test group assigned to the Sonicare ProtectiveClean® HX6848/92 with C2 Optimal Plaque Defense head HX9022/10 (electric toothbrush) and control group assigned to the Pierre Fabre Inava 20/100, a reference manual toothbrush. Subjects will be instructed to brush their teeth for one minute under supervision with their assigned toothbrush and a sodium monofluorophosphate (1450 ppm F) toothpaste (elmex® SENSITIVE PROFESSIONAL) with a low level of abrasion to minimize bias due to toothpaste abrasivity. After brushing, they will again be evaluated for primary and secondary outcomes (post-brushing). Subjects will be dismissed from the study site with their assigned toothbrush and toothpaste, and instructed to brush twice daily at home for the next 12 weeks. The subjects will be instructed to brush for two minutes during each tooth brushing. The subjects will report to the study site after 12 weeks of product use, at which time they will be re-evaluated for gingival abrasion, as well as for plaque removal, gingival inflammation, gingival recession and gingival color. Data (photographs and clinical measurements) will be collected, i.e. primary and secondary variables of each patient, by blinded examiners.