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NCT ID: NCT05175755 Not yet recruiting - Clinical trials for Perinatal Depression

Genetic Risk Factors Predictive of the Occurrence of Maternally Diagnosed Perinatal Depression in Women

PsyCOVIDUMGEN
Start date: September 25, 2023
Phase: N/A
Study type: Interventional

In December 2019, infection with a novel coronavirus SARS-CoV-2 emerged in China and has since spread throughout the world. Forms of varying severity of COVID-19, a disease induced by this emerging virus, have been described in pregnant women. In addition to the direct effects of the virus on the pregnant woman and the fetus, the pandemic context itself is likely to act as a psychological risk factor and to alter the protective factors for mental disorders. This pandemic context is in itself anxiety-provoking, even traumatogenic, particularly because of the potentially lethal infectious risk that it carries, all the more so in psychologically vulnerable populations. In addition to the fear of viral contamination, in the perinatal period, the fear of childbirth also includes a more or less important part of anxiety-producing uncertainty. This addition of stress factors is likely to increase the prevalence of perinatal anxiety disorders, particularly psychotraumatic experiences of childbirth and peri-traumatic dissociative states. Health and social measures, such as confinement, restriction of access of accompanying persons to maternity services, or contagious isolation of mothers suspected of being infected or infected, which may furthermore impose a mother-infant separation, are also likely to have psychopathological consequences. Studies specifically concerning the psychological effects of the COVID-19 pandemic context have been published. Among them, the French COVIPREV study, carried out in the general population during the first and second week of the containment period (beginning mid-March 2020), reported a prevalence of anxiety of 26.7% and 21.5% respectively. These prevalences are significantly higher than the usual prevalence estimated at 13.5% in the same population. Many international studies show an increase in the prevalence of postnatal depression in the current pandemic context. In the population of pregnant women, an Italian study on the psychological impact of the COVID-19 pandemic in 100 women in pregnancy, with no psychiatric history, in Naples during the second half of March 2020, found a positive score on the Impact of Event Scale-Revised (IES-R) for more than half of the women and a positive anxiety score on the State-Trait Anxiety Inventory (STAI-S) for 68% of the women The same observation was made in Quebec where two cohorts of pregnant women (between 4 and 41 weeks of amenorrhea) subjected to self-questionnaires evaluating different dimensions of their mental health, a first one recruited before the pandemic phase of 496 women and a second one of 1258 women recruited online between April 2 and 13, 2020, have been analyzed. Women in the second cohort had significantly higher levels of depressive and anxiety symptoms, more dissociative symptoms and post-traumatic stress symptoms. In China, a multicenter study in 25 hospitals in 10 provinces across the country that included 4124 women in the third trimester of pregnancy from January 1 to February 9, 2020, when the epidemic was publicly announced on January 20, 2020, again reported increased levels of anxiety and depressive symptoms on the Edinburgh Postnatal Depression Scale (EPDS) in pregnant women after the announcement compared to before. Finally, similar results are reported by Turkish researchers showing again a high prevalence of depressive symptoms during pregnancy (35.4%) during the COVID-19 pandemic. In the perinatal context, it has been documented that post-traumatic stress disorder is strongly associated with the risk of perinatal depression. In the context of the COVID-19 pandemic, three maternity units of the PREMA University Hospital Federation (FHU PREMA), the Paris Saint-Joseph Hospital Group (GhPSJ), the Louis Mourier Hospital (APHP) and the Port-Royal Maternity Unit (APHP), in partnership with the Boulevard Brune Psychopathology Center (CPBB) and the Psychiatry Department of the Louis Mourier Hospital (APHP), have set up, as of June 2020 a care protocol consisting of a screening offered systematically to women in postpartum at D1 of their delivery, intended to identify those presenting anxiety and depressive perinatal symptoms using the Edinburgh Postnatal Depression Scale (EPDS). Thus, the PsyCOVIDUM project to estimate the prevalence of depressive symptoms in the immediate postpartum period just after delivery at different times during the pandemic episode was initiated in the three FHU PREMA maternity hospitals. This study aims at the constitution of a DNA and serum biobank in voluntary women presenting or not a depression with an antenatal onset identified at the maternity hospital. This collection would eventually allow the evaluation of the role of inflammatory and genetic biological factors in the occurrence of antenatal onset depression on an independent cohort.

NCT ID: NCT05175300 Not yet recruiting - Hip Arthropathy Clinical Trials

Interest of a Highly Cross-linked Polyethylene Acetabular Component Doped With Vitamin E in Total Hip Arthroplasty of the Young and Active Subject

ICARE
Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Interest of a highly cross-linked polyethylene acetabular component doped with vitamin E in total hip arthroplasty of the young and active subject.

NCT ID: NCT05165030 Not yet recruiting - Clinical trials for Chiari Malformation, Type 1

Identification of Genetic Mutations Involved in Chiari Type I Malformations

ChiariGene
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Although most cases of Chiari malformation type I (CM1) are sporadic, familial cases of CM1, with or without syringomyelia, suggest a genetic cause in the pathogenesis of these malformations. The hypothesis is that there is one or more genes, in particular among those involved in the development of the axial skeleton and the cranium, which could lead to an abnormal morphology of the posterior fossa resulting in tonsillar herniation defining CM1. The abnormal circulation of cerebrospinal fluid due to tonsillar herniation is believed to be responsible, in some patients whose predisposing factors remain to be determined, for the progressive onset of associated syringomyelia. Since the determinants underlying the development of the posterior fossa of the skull are multigenic, the analysis of familial cases would make it possible to reduce genetic and phenotypic heterogeneity allowing to identify common pathogenic variants. For this study the investigators will be taking a blood sample to perform whole exome sequencing, build a biological collection and record imaging and clinical data.

NCT ID: NCT05161026 Not yet recruiting - Clinical trials for Myeloid Leukemia, Acute

Impact of Allo-HSCT on Bone Remodeling: Evolution of Bone Mineral Density and Architecture Measured by Bone Densitometry

REMODALLO
Start date: December 10, 2021
Phase: N/A
Study type: Interventional

Evaluation of variation of mineral density and bone microarchitecture after allogeneic HSCTs transplant in hematologic malignancies. Comparison with the general population.

NCT ID: NCT05160337 Not yet recruiting - Healthy Clinical Trials

Validation of the Stability of Diagnostic Biomarkers on Healthy Volunteers

Start date: August 2024
Phase: N/A
Study type: Interventional

Stability studies on the peripheral biomarkers (lncRNAs, sncRNAs, mRNAs, proteins, lipids/metabolites) measured by Firalis IVD test candidates and effect of gender, age, nutrition on their expression level

NCT ID: NCT05159830 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Cannabidiol for Reducing Drinking in Alcohol Use Disorder

CARAMEL
Start date: June 1, 2024
Phase: Phase 2
Study type: Interventional

The non-psychotomimetic cannabis compound cannabidiol (CBD) has been found effective for reducing alcohol drinking in mice. Moreover, other experimental studies have found that CBD reduced alcohol-induced steatosis in the liver, and reduced alcohol-related injury in the brain. Despite these promising results from animal data, no human study has been conducted yet in alcohol use disorder (AUD).

NCT ID: NCT05154474 Not yet recruiting - Metastatic Cancer Clinical Trials

Assessment of Sarcopenia at Diagnosis for Patients With Previously Untreated Metastatic Cancer or Hematologic Malignancy

SPACE2
Start date: June 2022
Phase:
Study type: Observational

Sarcopenia is defined as reduction in muscle mass and function according to the criteria of the European Working Group on Sarcopenia in older people. Initially described for elderly patients, it is also presented as a negative prognostic factor in overall survival in oncology in certain locations (lung, ENT pathways, colon, pancreas) and more controversially for hemopathies. Its screening by measurement of skeletal muscle mass by CT scan and / or PET scan against L3 and by physical functional tests is not routinely integrated despite international recommendations. Sarcopenia is one of the characteristics of patient fragility that can induce more complications, lengthen the average length of hospital stay and reduce overall survival. The PRONOPALL score, a predictor score for survival validated by a previous study, will be correlated with the presence (or absence) of sarcopenia at inclusion for patients with a solid tumor (breast, ovary, prostate cancer , kidney, lungs, pancreas, colorectal). A prospective study on 38 patients with metastatic cancer was carried out at the Victor Hugo clinic in Le Mans between 01/JUN/21 and 31/AUG/21 (SPACE, ClinicalTrials.gov number, NCT04714203): 25 patients were analyzable on the CT and PRONOPALL score data with a prevalence of sarcopenia of 60% and median overall survival of 14 months (unpublished data), clinical performance and muscle strength tests were not carried out (as in the publications cited above). A prospective study for the detection of sarcopenia is indicated by extending to blood diseases with the integration of clinical tests included in the initial APA (Adapted physical activity) assessment recommended for diagnosis.

NCT ID: NCT05153538 Not yet recruiting - Clinical trials for Disabilities Multiple

Evaluation of Implant Therapies Performed Under General Anesthesia in Patients With Specific Dental Needs

Start date: December 1, 2021
Phase:
Study type: Observational

Implant placement is the solution of choice for replacing missing teeth in a fixed way. However, dental practitioners and surgeons are reluctant to place implants in the population of patients with special needs. They argue different arguments which involve various risk factors. A systematic review shows that it is clear that there is a gap in knowledge about implant placement in patients with special needs in order to argue the choices of prosthetic rehabilitation or abstention based on a scientific evidence-based approach. There is a need of studies with a large number of patients and implants. The Unit of Special Care Dentistry at the University Hospital of Clermont-Ferrand started to place implants in 2007. This study should present the evaluation of the survival, success and failure rate of implants placed under general anesthesia and of the prosthesis rehabilitation that followed.

NCT ID: NCT05150379 Not yet recruiting - Shoulder Injuries Clinical Trials

Influence of the Dominance of the Shoulder Stabilized by the Open Latarjet Procedure on the Functional Recovery of the Shoulder at 4.5 Months Postoperatively.

Dom Lat
Start date: December 5, 2021
Phase:
Study type: Observational

The aim of this study is to quantify the functional deficits as a function of the dominance of the shoulder stabilized by the open procedure of Latarjet at 4.5 months postoperatively compared to healthy controls.

NCT ID: NCT05150275 Not yet recruiting - Hysterotomy Clinical Trials

Study Comparing Classic Vaginal Hysterectomy to vNOTES Hysterectomy

H-vNOTES
Start date: December 2021
Phase:
Study type: Observational

vNOTES is a new surgical approach that has been used for less than 10 years. Several studies compare it to laparoscopy but none compare it to the classic vaginal route. The aim of the research is to analyze postoperative pain