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NCT ID: NCT05271968 Not yet recruiting - Scabies Clinical Trials

Place of Hygiene in Scabies's Treatment in Populations in Precarious Situations

GALEHYGIE
Start date: April 2022
Phase: N/A
Study type: Interventional

Scabies is a parasitic pathology contracted mainly through human contamination. It is caused by a parasite (Sarcoptes Scabiei var. hominis) which lodges into the top layer of the epidermis creating a burrow, which can measure 5 mm to 15 mm, where the female lays her eggs. After 4-6 weeks the patient develops an allergic reaction to the presence of mite proteins and feces in the scabies burrow, causing intense itch and rash. The usual adult form, called common scabies, is characterized by this nocturnal pruritus, and typical and/or atypical lesions. The typical lesions are the vesicle (translucent vesicle on an erythematous base), the scabious burrow (due to the tunnel dug by the female in the stratum), and the papulo- nodule -nodular scabious (red/brown infiltrated on palpation, predominantly on the male genital areas). They predominate in certain regions: the interdigital region of the hands, the anterior face of the wrists, the external face of the elbows, the axillary region, the areolas, the nipples, the umbilical region, the male external genitalia, the buttock region, the face inner thighs. Scabies occurs worldwide. However, studies have shown a greater prevalence among populations that do not have access to common hygiene measures: poor, young children and elderly in resource -poor communities, migrant, homeless populations, etc. The "Baudelaire outpatient clinic" (BOPC) at St Antoine hospital in Paris offers general medicine consultations. It has the particularity of offering a so called "Permanent d'Accès Aux Soins" service that allowed any person without health assurance to have access to a general practitioner and treatment, free of charge and help to recover its social rights. Consequently, more than 60% of the patients encountered at the consultation of the BOPC are in a precarious situation. Usually, poor patients with scabies may be offered a shower and clean clothes at the BOPC Therefore it seemed to us the ideal place to evaluate a treatment's scabies in this population including the hygiene treatment.

NCT ID: NCT05271955 Not yet recruiting - Clinical trials for Autism Spectrum Disorder

e-GOLIAH in Autistic Spectrum Disorders

e-GOLIAH-ECO
Start date: June 15, 2022
Phase: N/A
Study type: Interventional

Randomized open-label study comparing children aged 3 to 6 years with autism and normal cognitive development or mild cognitive impairment receiving the usual treatment plus intensive use of eGOLIAH (experimental group) with children receiving only the usual treatment (control group). eGOLIAH (Gaming Open Library for Intervention in Autism at Home) is an accessible online platform for digital games inspired by the principles of the Early Start Denver Model (ESDM), one of the care programs validated in the management of young ASD. The duration per patient will be one year. The exposure to e-GOLIAH for the experimental group will be done with the recommendation of intensive exposure to the game (5 sessions> ½ hour per week). Clinical variables will be assessed at entry, 6 months and 1 year (end of study). The EQ5D questionnaires will be collected by the supervising therapist during the follow-up visit and at the same time as the clinical variables.

NCT ID: NCT05271929 Recruiting - COVID-19 Clinical Trials

Early High-Titre Convalescent Plasma in Clinically Vulnerable Individuals With Mild COVID-19

COVIC-19
Start date: April 1, 2022
Phase: Phase 3
Study type: Interventional

- Research Question: Does convalescent plasma (CCP) collected from donors who have recovered from COVID-19 and who have a very high titre of anti-SARS-CoV-2 antibodies reduce the risk of hospitalisation (for COVID-19) or death in patients with early symptoms of acute COVID-19 who are vulnerable to this disease compared to standard of care? - Study product: Very high antibody titre COVID-19 convalescent plasma collected more than 15 days after end of symptoms in COVID-19 patients who also had received at least one dose of a SARS-CoV-2 vaccine. - Methodology: Multicentre, randomised, open-label, adaptive superiority trial: COVID-19 very high neutralizing Ab titre convalescent plasma vs standard care in 2 cohorts of vulnerable patients (cohort 1: elderly (≥ 70 years) and younger with comorbidities, cohort 2: immunosuppressed patients). - Study phase: Phase 3 - Intervention: Two units of high antibody titre COVID-19 convalescent plasma to individuals randomised to the intervention group, 2 units from 2 different donors, preferably transfused on the same day. Plasma provided by convalescent vaccinated donors with a minimum antibody titre of 1:640 against delta variant (B1.617.2) or antibody concentration >=4.000 BAU/ml in the QuantiVac anti-SARS-CoV-2 IgG ELISA or >=20.000 U/ml in the Elecsys anti-SARS-CoV-2 CLIA - Randomisation: 1:1 (standard of care + convalescent plasma vs. standard of care) stratified by centre (cohorts 1 and 2)

NCT ID: NCT05271812 Not yet recruiting - Breast Feeding Clinical Trials

Professional Supporting and Women's Education for Breastfeeding Promotion: Preliminary Study

PSWED
Start date: March 2022
Phase:
Study type: Observational [Patient Registry]

Background The long-term benefits of breastfeeding for newborns and mothers are undeniable and scientifically recognized. Current WHO/UNICEF guidelines suggest increasing exclusive breastfeeding to 75.0% by 2030 worldwide. However, there is substantial heterogeneity in breastfeeding practices around the world. Because while breastfeeding promotion is complex, breastfeeding instructions remain without any educational design in general. Primary Objective: - Determine the effectiveness of breastfeeding educations among the nursing mothers during first month after childbirth. Secondary objectives: - Identify the theoretical and pedagogical engineering framework the breastfeeding educations proposed in antenatal among nursing mothers and professionals. - Assess the perceived usefulness of nursing mothers regarding to the educational interventions for breastfeeding management and its frequently complications. - Assess the perceived usefulness of professionals, regarding to the pedagogical engineering of educational interventions offered to nursing mothers. - Assess women's competency regarding to the educational interventions for breastfeeding management and its frequently complications. - Evaluate the organization of educational interventions proposed by professionals. Method & Results: The results will be obtained by calculating the mean, standard deviation, median and interquartile range. The Chi-square and Yates' uncorrected and corrected tests will be applied for comparison calculation. Evaluating criteria for feeling of usefulness and breastfeeding competency will be studied using Likert's four level model, 10-Point numerical scales and short answer questions. The relationships between these variables will be studied by using a sequential mixed method combining interpretative, comprehensive, and explanatory approach.

NCT ID: NCT05271409 Recruiting - Clinical trials for Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease

Meteoroid
Start date: August 30, 2022
Phase: Phase 3
Study type: Interventional

The main objective of the study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period

NCT ID: NCT05271383 Active, not recruiting - Clinical trials for Orthognathic Surgery

Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery

CMF-ORTHO
Start date: February 4, 2022
Phase:
Study type: Observational [Patient Registry]

This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK®) used for orthognathic surgery.

NCT ID: NCT05270668 Recruiting - Clinical trials for Interstitial Lung Disease

Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)

ATHENA-SSc-ILD
Start date: July 13, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.

NCT ID: NCT05270044 Active, not recruiting - Melanoma Clinical Trials

Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.

COLUMBUS-AD
Start date: May 2, 2022
Phase: Phase 3
Study type: Interventional

The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).

NCT ID: NCT05269394 Recruiting - Dementia Clinical Trials

Dominantly Inherited Alzheimer Network Trial: An Opportunity to Prevent Dementia. A Study of Potential Disease Modifying Treatments in Individuals With a Type of Early Onset Alzheimer's Disease Caused by a Genetic Mutation (DIAN-TU)

DIAN-TU
Start date: December 22, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

To assess the safety, tolerability, biomarker, cognitive, and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug improves disease-related biomarkers and slows the rate of progression of cognitive or clinical impairment.

NCT ID: NCT05269368 Recruiting - Clinical trials for Post-Op Complication

Interest of Wicking for Ossicular Surgery and Myringoplasty

MECH-ORL
Start date: May 16, 2022
Phase: N/A
Study type: Interventional

Myringoplasties and ossicular surgery are very common procedures. Following these otological surgeries, most surgeons install a wicking. This intervention consists of placing a wick, absorbable or not, in the external acoustic meatus, after having replaced the tympanomeatal flap.