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NCT ID: NCT05524311 Recruiting - Clinical trials for Juvenile Dermatomyositis

Baricitinib in the Treatment of New-onset Juvenile Dermatomyositis (MYOCIT)

MYOCIT
Start date: November 10, 2022
Phase: Phase 2
Study type: Interventional

The MYOCIT study aims to evaluate the efficacy and safety of baricitinib in association with corticosteroids in new-onset patients with juvenile dermatomyositis (JDM) in a phase II trial with the objective to obtain a better efficacy than the conventional combination methotrexate (MTX) and corticosteroids over the 24 week study period. Thus, the investigators hypothesize that baricitinib could be used as a first line treatment in all forms of DMJ, including the most severe one, with a good safety profile.

NCT ID: NCT05524051 Recruiting - Clinical trials for Acute Kidney Injury Following Cardiac Surgery

A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery.

Start date: March 3, 2023
Phase: Phase 2
Study type: Interventional

This is a randomized, multi-centric, placebo-controlled, participant and investigator-blinded study to evaluate the safety, tolerability and efficacy of TIN816 in adult patients at risk for acute kidney injury following cardiac surgery.

NCT ID: NCT05523999 Recruiting - Cardiac Arrest Clinical Trials

Recognition of a Cardiac Arrest Within the EMS

ACR90
Start date: June 3, 2024
Phase:
Study type: Observational

This study aims to evaluate the average time taken by the Medical Regulation Assistants (MRA) to detect a cardiac arrest during the call to the EMS as well as the factors influencing this delay. Its main objective is to evaluate the delay, in seconds, between the call being picked up and the recognition of a cardiac arrest by the medical regulation assistant at the EMS 95

NCT ID: NCT05523895 Recruiting - Clinical trials for Irritability Associated With Autism Spectrum Disorder

Pimavanserin for the Treatment of Irritability Associated With Autism Spectrum Disorder

Start date: August 9, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

6-week, randomized, double-blind, fixed-dose, placebo-controlled, parallel group study in children and adolescents (aged 5 to17 years) with autism spectrum disorder (ASD) with irritability, agitation, or self-injurious behaviors to study the efficacy and safety of pimavanserin

NCT ID: NCT05523713 Recruiting - Hepatectomy Clinical Trials

Development and Validation of a Predictive Score for Surgical Site Infections

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

More than 8 millions surgical interventions are carried out each year in France. Postoperative complications, in particular infectious, can occur in 10 to 60% of cases and are the cause of postoperative revision in 30% of cases, an increase in mortality, length of stay, readmissions and lead to significant additional socio-economic costs. Currently, improvements in surgical practices have not reduced the incidence of surgical site complications. In this context, the development of predictive scores for the risk of post-operative complication becomes urgent in order to implement new interventions (pre-habilitation) or to modify surgical decisions (timing, approach) in order to reduce the risk of complications before surgery. Several recent studies highlights the importance of the immune response in postoperative prognosis. In particular, an imbalance between the adaptive and innate response involving MDSCs has been demonstrated in patients with postoperative complications.Thanks to new techniques for analyzing the immune system, in-depth analysis of the immune system before surgery is a very promising approach aimed at identifying predictive biomarkers of postoperative prognosis. Our team has developed and patented a multivariate model integrating mass cytometry data, proteomics and clinical data collected before surgery to accurately predict the occurrence of a surgical site complication (AUC = 0.94, p<10e-7) in a monocentric cohort of 43 patients to major abdominal surgery (Stanford University). The objective of the present study is to generalize and validate this preoperative predictive score of infectious complications of the surgical site in the 30 days following major digestive surgery on a larger workforce within a multicenter cohort and to validate this score at using a machine learning method.

NCT ID: NCT05523583 Recruiting - Clinical trials for Lung or Head and Neck Cancer

Assessment of Tobacco Smoking and Alcohol Drinking and Treatment Outcomes Among Patients With Lung or Head and Neck Cancer

SMALLHAN
Start date: October 27, 2022
Phase:
Study type: Observational

The overarching goal of the proposed study is to provide information which can lead to effective implementation of cessation support in the care of smokers diagnosed with lung or head & neck cancer. To achieve these aims, the study propose to conduct a longitudinal cohort study of patients diagnosed with lung or head & neck cancer at the Hospices Civils de Lyon (SMALLHAN). Briefly, adult patients newly diagnosed with lung or head & neck cancer will be recruited at the time of diagnosis (announcement of diagnosis and consultation).

NCT ID: NCT05523531 Completed - Dry Eye Clinical Trials

Prospective Single-center Long-term Follow-up Study of a Series of Cases Previously Included in the QUALVIDON Study

QUALVIDON2
Start date: September 15, 2022
Phase:
Study type: Observational

Dry eye affects millions of people around the world. Some dry eye patients complain of neuropathic eye pain that can affect their quality of life. From August 2016 to June 2017, the QUALVIDON study (NCT03296111), conducted at the Adolphe de Rothschild Foundation Hospital, assessed pain and its impact on quality of life using self-administered questionnaires in a series of dry eye patients. This 2nd study, entitled QUALVIDON2, focuses on the outcome of patients previously included in QUALVIDON.

NCT ID: NCT05523219 Completed - Hallux Valgus Clinical Trials

Prospective Observational Study for the Evaluation of VEOFIX Varisation Staples

Start date: February 15, 2021
Phase:
Study type: Observational

This clinical investigation was led as a post-market clinical follow-up study (post-market device development stage). Therefore, its objectives were as follows: - To assess functional clinical score's evolution, - To evaluate patient's satisfaction - To confirm safety of varisation staples The target population for this study was any adult patient implanted with VEOFIX varisation staples in their intended uses between 15/02/2021 and 15/05/2021. Patients were implanted and followed as per standard of care led in the investigational site. The following regulation and guidelines were followed for this investigation: - Standard ISO 14155:2020 "Good Clinical Practice"undirectly applicable; - Regulation (UE) 2016/679 (RGPD) ; - Regulation (UE) 2017/745 (MDR) ; - MEDDEV 2.12.1; - Local regulation (loi " jardé ", loi " informatique et libertés "). As per its design, the investigation is considered as involving human beings, and therefore require submission to an ethic committee or declaration to a Competent Authority (ANSM) and CPP. This study was registered on CPP (CPP Ile de France VII).

NCT ID: NCT05523167 Recruiting - Dermatomyositis Clinical Trials

A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.

ALKIVIA
Start date: October 12, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study's purpose is to measure the treatment response from efgartigimod PH20 SC compared with placebo in participants with Idiopathic Inflammatory Myopathy (IIM). Participants with the IIM subtypes of dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), or certain other subtypes of polymyositis (PM; including antisynthetase syndrome [ASyS]) will be included in the study. Treatment response will be measured by Total improvement score (TIS). Additional information can be found on https://myositis-study.com/.

NCT ID: NCT05523063 Withdrawn - Breast Cancer Clinical Trials

Effect of Physical Activity in Patients With Breast Cancer.

APACAM
Start date: September 2022
Phase:
Study type: Observational

Every year in France, there are approximately 58,000 new cases of breast cancer, which is the leading cancer in women according to the National Cancer Institute. Among the various tools in the fight against cancer, it is now proven that physical activity improves the prognosis of cancers, particularly breast cancer. Indeed, APA (Adapted Physical Activity) reduces morbidity and mortality, the risk of recurrence and improves quality of life. It is one of the tools of the Ten-Year Cancer Control Strategy 2021-2030 of the anti-cancer plan. However, it seems to be insufficiently proposed and prescribed in France at present. CAMI (Cancer Arts Martiaux et Information) is a non-profit association comprising health professionals specifically trained to support cancer patients through APA. It works in collaboration with the Hospices Civils de Lyon and in particular the Gynecology Department of the CHU (University Hospital Center) of Croix Rousse. According to the World Health Organization (WHO), quality of life is "an individual's perception of his or her place in life, in the context of the culture and value system in which he or she lives, in relation to his or her goals, expectations, norms and concerns. It is a very broad concept influenced in a complex way by the subject's physical health, psychological state, level of independence, social relationships as well as their relationship to the essential elements of their environment." Quality of life is thus synonymous with well-being, perceived health and life satisfaction. The quality of a person's life is based both on the objective elements of his or her life (physical health, living environment and material and/or contextual conditions) and on his or her experience, which can be defined as the subjective quality of life. Thus, quality of life is considered to be a multidimensional concept that is structured around four dimensions, the first of which encompasses the physical state (autonomy, physical abilities), the second the somatic sensations that often translate into the expression of pain, the consequences of trauma related to the disease or treatment. With the increase in the incidence of breast cancer and the improvement in its prognosis, the number of breast cancer survivors has increased significantly. Quality of life has become an important outcome measure in clinical breast cancer surveys and survival studies, in addition to survival. The investigators' main objective is to study the effects of APA managed by CAMI in routine practice, on the quality of life of breast cancer patients. They also want to analyze how, by whom, and which patients are referred to CAMI to improve their care and describe the program offered by CAMI. The aim of this research is therefore to establish an axis of work and improvement for the Gynecology Department of the Croix Rousse Hospital in order to better identify the patients for whom APA would be most beneficial, to better refer them to CAMI and to study in real practice the effects of APA on these patients.