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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: NCT05387525 Recruiting - Keratosis, Actinic Clinical Trials

A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp

AKtive
Start date: October 24, 2022
Phase: Phase 4
Study type: Interventional

The purpose of the study is to evaluate the incidence of biopsy confirmed invasive squamous cell carcinoma (SCC) in the selected treatment field (TF) after administration of topical tirbanibulin 10 milligram (mg)/gram (g) ointment or diclofenac sodium 3 percent (%) gel over the 3-year study period.

NCT ID: NCT05387395 Completed - COVID-19 Clinical Trials

COVID-19 on Disease Activity in Radiologically Isolated Syndrome Cohort

VaxiRIS
Start date: May 31, 2022
Phase:
Study type: Observational

The Radiologically Isolated Syndrome (RIS) is defined as incidental Magnetic Resonance Imaging (MRI) abnormalities fulfil the criteria for dissemination in space, suggestive of multiple sclerosis. Nowadays, mandatory vaccination in patients with multiple sclerosis (MS) is widely recommended. Regarding COVID19, the absence of specific warnings led to the proposal of vaccination in patients with inflammatory diseases of the central nervous system. We aimed to evaluate if COVID19 vaccination or infection increased the risk of clinical conversion to multiple sclerosis or evidence of disease activity (EDA) in a cohort of RIS subjects.

NCT ID: NCT05386680 Active, not recruiting - Clinical trials for Spinal Muscular Atrophy

Phase IIIb, Open-label, Multi-center Study to Evaluate Safety, Tolerability and Efficacy of OAV101 Administered Intrathecally to Participants With SMA Who Discontinued Treatment With Nusinersen or Risdiplam

STRENGTH
Start date: January 12, 2023
Phase: Phase 3
Study type: Interventional

This is an open-label, single arm, multi-center study. Approximately 28 participants aged 2 to <18 years will be enrolled stratified as 2 to 5 years and 6 to < 18 years. The study is comprised of 3 periods, Screening (up to 45 days), Treatment (1 day), and Follow-up (52 weeks).

NCT ID: NCT05386550 Recruiting - Clinical trials for Head and Neck Cancer

Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)

Start date: October 6, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period.

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: NCT05386108 Recruiting - Neoplasms Clinical Trials

Study of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/HER2- Breast Cancer

ELECTRA
Start date: August 31, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with with or without brain metastases from ER-positive, HER-2 negative breast cancer. Phase 1b is designed to select the recommended phase 2 dose and will be followed by a phase 2 evaluation of elacestrant in combination with abemaciclib in patients with active brain metastases from ER-positive, HER-2 negative breast cancer.

NCT ID: NCT05386017 Recruiting - Clinical trials for Overweight and Obesity

Post-interventional Future for Adolescents From the PRALIMAP-INÉS Trial

PRALIMAPCINeCO
Start date: December 13, 2022
Phase:
Study type: Observational

The research focuses on a follow-up measure of participants in the PRALIMAP-INÈS cohort (NCT01688453 - Legrand et al. 2017). PRALIMAP-INÈS was conducted between 2012 and 2015 with the objective of showing that adapted overweight support for less advantaged adolescents has an effect equivalent to standard support for advantaged adolescents in the short term. This trial included 3 measurement times: T0 (before intervention), T1 (after intervention, at the end of the school year), T2 (after intervention) and of the school year), T2 (one year later). The proposed research is a continuation of PRALIMAP-INÈS with the addition of a 4th measurement time (T3) to study the trajectories of the intervention. (T3) to study the long-term social, economic, educational and health trajectories (in particular weight) of weight) of adolescents who have become young adults.

NCT ID: NCT05385666 Recruiting - Clinical trials for Psychological Disorder

Collaborative Mental Health Care Model: an Evaluation of the Implementation of a Pilot in Four Primary Care Organization

Mosaique
Start date: July 13, 2022
Phase: N/A
Study type: Interventional

Frequent mental disorders (anxiety or mood disorders), an important part of primary care patient care, remain insufficiently detected and treated. Improving their care requires better coordination between general practice and specialized care. The collaborative care model developed in Washington State with the introduction of a care manager is recognized. About 100 randomized controlled trials have established its effectiveness and efficiency, in terms of improving the progression of disorders (remission rate), adherence, quality of life, professional and patient satisfaction, and cost savings. However, the possibility of implementation of these validated care remains to be explored. A dozen collaborative care implementation studies exist, all conducted in the USA and not having considered all the dimensions of the indicators of penetration, acceptability/adoption, feasibility, fidelity and cost. A first implementation in France is implemented since September 2021 in the Yvelines department on four sites of different size, organization and environments: the multi-professional health centers (MSP) of Mureaux and Celle St Cloud, the Chevreuse medical house and MG in isolated practice in Versailles. The main objective of the research project is to evaluate the first implementation in France of collaborative care for frequent psychic disorders according to the indicators of penetration, acceptability/adoption, fidelity, relevance, feasibility and cost.

NCT ID: NCT05385653 Recruiting - Bulimia Nervosa Clinical Trials

Pre-therapeutic Validation of the Virtual Reality-based Exposure Scenario for CBT "ReVBED" for the Induction of Food Craving in Patients With Bulimia and Binge Eating Disorder (BED)

RevBED
Start date: June 29, 2023
Phase: N/A
Study type: Interventional

Food craving is a major therapeutic issue in Eating Disorders with binge eating: the Bulimia Nervosa and the Binge Eating Disorder (BED). Food craving is linked to compulsive eating and its apprehension is currently based on classic Cognitive and Behavioural Therapies (CBT). However, it remains difficult to induce in therapy and a significant number of patients do not respond to classic CBTs. The development of exposure scenarios for CBT in virtual reality (VR) has allowed a gain in efficacy and in particular therapeutic effects lasting longer after treatment. Nevertheless, the stimuli used are often simple food visuals and insufficiently consider the many factors influencing food craving (physical, psychological, socio-environmental...) and VR immersion is still limited by the use of 3D laptops (fixed) rather than wireless headsets.