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NCT ID: NCT05563168 Withdrawn - COVID-19 Clinical Trials

Study Evaluating Diltiazem in Combination With Standard Treatment in the Management of Patients Hospitalized With COVID-19 Pneumonia

DICOV
Start date: April 2023
Phase: Phase 2
Study type: Interventional

SARS-CoV-2 infection is responsible for hypoxemic pneumonia, which is sometimes serious and associated with excess mortality. To date, with the exception of dexamethasone, which has shown clinical efficacy by reducing the mortality of infected patients, no other therapeutic strategy has demonstrated a curative clinical benefit, particularly in the initial stages facilitating viral eviction. . Based on the mechanism of action and the available data, diltiazem, administered in the first days post-infection, could facilitate viral eradication in these patients through the stimulation of the innate immune response of cells of the infected respiratory epithelium, actor in the fight against SARS-CoV-2. In this context, the investigators propose the DICOV trial, to demonstrate the ability of diltiazem to reduce the viral load more rapidly, in patients hospitalized for COVID-19 hypoxemic pneumonia.

NCT ID: NCT05561322 Withdrawn - Spine Surgery Clinical Trials

3rd-year Post-surgical Evaluation of Adjacent Segment Disc Degeneration Onset in Lumbar Spine (Spinal Fusion vs. Lumbar Arthroplasty With Disc Replacement)

ARTHRO-DEGE
Start date: February 27, 2024
Phase:
Study type: Observational

The main objective of the study is to compare the onset of adjacent segment disk degeneration in two groups of patients (one "spinal fusion group" and one "lumbar arthroplasty with disc replacement" group) with each patient acting as their own control for either group under study and more than three years of follow-up.

NCT ID: NCT05550519 Withdrawn - Clinical trials for Hepatitis B, Chronic

A Study in Chronic Hepatitis B e-Antigen Negative Participants After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment

SALMONS
Start date: October 31, 2022
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to assess the incidence of participants who reach hepatitis B surface antigen (HBsAg) seroclearance after discontinuing nucleos(t)ide analog (NA) therapy in participants with HBsAg less than or equal to (<=) 100 international units per milliliter (IU/mL) and participants with HBsAg greater than (>) 100 IU/mL to <= 500 IU/mL at baseline.

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.

NCT ID: NCT05411575 Withdrawn - COVID-19 Clinical Trials

Plerixafor in Acute Respiratory Distress Syndrome Related to COVID-19 (Phase IIb)

LEONARDO
Start date: July 19, 2022
Phase: Phase 2
Study type: Interventional

This phase IIb study, LEONARDO is a multicenter, randomized, double-blind, placebo- controlled, parallel group study, to assess the therapeutic efficacy and safety of Plerixafor in patients over 18 years of age, - with acute respiratory failure related to COVID-19 and - Recently admitted in ICU or equivalent structure (within 48 hours) for COVID-19 related respiratory failure - without invasive mechanical ventilation and - requiring oxygen support ≥ 5L/min to obtain a transcutaneous O2 saturation > 94% A total of 150 participants, will be randomized in a 2:1 ratio to receive either Plerixafor (n=100) or placebo (n=50) as a continuous IV infusion for 7 days (from D1 to D8) in addition to standard of care (e.g. glucocorticoids...). Safety data will be reviewed by an independent Data and Safety Monitoring Board (DSMB) during the study.

NCT ID: NCT05385341 Withdrawn - Clinical trials for Acute Coronary Syndrome

Rehabilitation Exercise With MObile Technology and Education After Acute Coronary Syndrome

REMOTE-ACS
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Despite a clear indication of grade Ia, cardiac rehabilitation (CR) is dramatically underutilized after acute coronary syndrome with less than 30% of patients addressed in France. Mobile technology has the potential to overcome barriers to access to cardiac rehabilitation and may be a useful tool for increasing participation. However, studies have to prove this type of care is as effective as traditional center based cardiac rehabilitation.

NCT ID: NCT05378958 Withdrawn - Chronic Disease Clinical Trials

Qualitative Phenomenological Study on Videoconferencing Therapeutic Education

Visio ETP
Start date: February 2023
Phase:
Study type: Observational

Therapeutic patient education (TPE) is one of the mechanisms that make patients with chronic disease as competent as possible to manage illness and treatment by helping them to be autonomous and responsible for their decision-making. The COVID-19 pandemic has changed the organization of care, prioritizing the emergency fight against the epidemic. The French High Authority of Health (HAS) has recommended maintaining individual TPE sessions by videoconference or telephone, based on the usual stages of the educational process. Several working groups have looked into remote TPE and recommendations have been issued in the form of practical advice but without questioning the participants, who did not participate in the reflection. No consensus, including health authorities, has been reached on this subject. At Necker Hospital, ETPs were carried out remotely, by videoconference. Understanding remote therapeutic education by videoconference through lived experience, by means of a one-hour interview, of the caregivers who deliver it and the parents of patients or the patients who receive it, will make it possible to better understand the effects of remote mode on therapeutic education sessions but also on professional practices and on participants. The benefit will be twofold: for caregivers: to facilitate the deployment of this new educational offer. For patients and their carers: give priority access to TPE to families who are far from the healthcare system or to patients who are too fragile to travel and thus reduce inequalities and geographical barriers.

NCT ID: NCT05341934 Withdrawn - Clinical trials for Cognitive Intervention to Modify Addiction Behaviour of Alcohol-dependent Patients

Evaluative Conditioning: A Brief Cognitive Intervention Aimed to Modify Addiction Behaviour of Alcohol-dependent Patients

CEAlcool
Start date: January 15, 2018
Phase: N/A
Study type: Interventional

Evaluative Conditioning: A Brief Cognitive Intervention Aimed to Modify Addiction Behaviour of Alcohol-dependent Patients

NCT ID: NCT05321862 Withdrawn - Multiple Myeloma Clinical Trials

Relevance Evaluation of [68Ga]Ga-PentixaFor for Initial Staging and Detection of Minimal Residual Disease in Multiple Myeloma Patients.

PENTI-MIDAS
Start date: March 14, 2023
Phase: Phase 2
Study type: Interventional

The aim of our study is to confirm the relevance of PET using [68Ga]Ga-PentixaFor ligand, in comparison with FDG, for initial staging and detection of minimal residual disease in multiple myeloma patients eligible for autologous stem cell transplantation less than 66 years. The prognostic value of positive CXCR4 expression will also be assessed and [68Ga]Ga-PentixaFor/FDG discordances explored.

NCT ID: NCT05300490 Withdrawn - Clinical trials for Articular Cartilage Disorder of Knee

Prednisolone Urinary Excretion Kinetics

URIPRED
Start date: May 2023
Phase:
Study type: Observational

The urinary elimination kinetics of glucocorticoids after intra-articular injection is very poorly documented. It is estimated that glucocorticoids may be present in the urine up to 6 weeks after intra-articular injection. However, this is not supported by any scientific literature. Despite this lack of evidence, in doping control practice, any presence of glucocorticoids in urine is accepted when the athlete provides evidence of an intra-articular injection that took place less than 6 weeks prior to the doping control. Many doping cases are open to challenge because they are based solely on measurements of prednisolone concentrations and its blood esterase product, prednisone. In order to demonstrate the use of prednisolone for doping purposes (systemic and not intra-articular use), it is therefore necessary to know the urinary elimination kinetics of prednisolone and prednisone, as well as the evolution of the concentration ratio between these 2 molecules.