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NCT ID: NCT06027632 Not yet recruiting - Breast Cancer Clinical Trials

Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer

COG STIM 2
Start date: September 2023
Phase: N/A
Study type: Interventional

Investigator propose the first French randomized comparative study to assess the efficacy of a remotely supervised online cognitive stimulation program, compared to an unsupervised online cognitive exercise intervention, in reducing cognitive complaints in localized breast cancer patients after adjuvant chemotherapy. Previous randomized studies have confirmed the effectiveness of online cognitive stimulation programs compared to standard care. The study seeks to determine the added value of remote supervision by a neuropsychologist. The control group will have access to the same online cognitive exercises as the experimental group but without supervision. Investigator has chosen not to include a wait-list group as it would be unethical to deny patients with cognitive complaints the opportunity to participate in an intervention expected to benefit them. The secondary objective is to evaluate the benefit of the supervised digitalized cognitive intervention on objective cognitive impairment. The research hypothesis is that incorporating personalized remote support with supervision from a neuropsychologist into a digitalized cognitive stimulation program will reinforce the effectiveness of the intervention on cognitive complaints. This will be achieved by improving participation/adherence to the online cognitive stimulation program, as well as through the personalized supervision itself. Investigator believe that the supervision sessions, including educational components, will enable patients to identify their strengths, promote their cognitive awareness, and develop individualized strategies to apply their compensatory abilities in real-life situations. Since cognitive difficulties have multiple underlying causes, reducing these symptoms requires a multifaceted approach. The hypothesis is that combining cognitive training (which increases neuroplasticity and directly targets the cognitive domains affected by cancer and its treatments), with structured supervised educational sessions based on compensatory strategies, will yield better outcomes than online cognitive stimulation alone.

NCT ID: NCT06026722 Not yet recruiting - Clinical trials for Gambling Disorder Treatment

Behavioral and Cognitive Therapy for Insomnia in the Treatment of Pathological Gambling

SOMJEU
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Gambling is a public health risk. The wide panel of games available (poker, sport bets, scratch card games, slot machines, stock speculation …) and the advent of the Internet means that this behaviour is increasingly monitored on an epidemiological level, to the point where its pathological practice is now recognized in the DSM-5. Indeed, the scientific literature suggests a bidirectional link between use disorders and sleep disorders. Sleep deprivation is known to lead to impaired judgment (risk-taking), increased sensitivity to reward, attentional difficulties and poor emotional management. The reverse has also been demonstrated: for example, playing at night has an impact on sleep quality, particularly in terms of difficulty falling asleep, ruminations about the game and a delay in the sleep-wake phase. Sleep disorders also affect patients undergoing withdrawal and/or cessation of a substance or behavior. This established link between addictions and circadian rhythms is important, since it is suggested that patients who are more impaired in both respects are more likely to relapse and respond less well to treatment. In addictology, Behavioral and Cognitive Therapy for Insomnia (CBT-I) has proved effective in alcohol-dependent subjects in four studies. All reported a better quality of life (less depressive cognitions, better lifestyle) after CBT-I, although only one study reported a numerical reduction in consumption.The treatment of substance use disorders (AUD) remains limited : no pharmacological treatment has proved its worth, and the reference treatment remains mainly CBT. Despite the indisputable effectiveness of CBT, between 14% and 50% of patients are reported to have broken off from follow-up and care, and almost 90% of patients end up relapsing.

NCT ID: NCT06026592 Not yet recruiting - Acute Kidney Injury Clinical Trials

Detection of Plasma DNA of Renal Origin in Kidney Transplant Patients

DART-REIN
Start date: September 30, 2023
Phase:
Study type: Observational

Donor-derived cell-free DNA (dd-cfDNA) has been proposed as a potential diagnostic tool to monitor the rejection status of the kidney transplant. It has been suggested that dd-cfDNA is increasing in the blood of kidney transplant patient presenting a graft rejection. In this project, investigators proposed a different approach to predict and characterize kidney transplant rejection/dysfunction based on the quantification of epigenetic signatures present on the donor-cell-free DNA. In 2018, Moss et al. develops a deconvolution model capable of identifying the tissue origin of circulating DNA by taking advantage of its epigenetic properties. The study confirmed that the cell-free DNA circulating in healthy subjects comes mainly from blood cells and endothelial cells, but not from kidney cells. In this study, researchers investigate the evolution of blood renal-specific cell-free DNA amount in patient with chronic kidney disease before and after the transplantation surgery by testing a set of renal-specific epigenetic markers. The purpose of this study is to identify the biological noise of "native kidney" on renal-specific cell-free DNA and to compare it with signal coming from "transplanted kidney".

NCT ID: NCT06024538 Not yet recruiting - Lung Neoplasm Clinical Trials

Role of Cancer-associated Fibroblast, MDSCs and Immune Cell Interplays in the Resistance of Non-small Cell Lung Cancer to Anti-PD1/PD-L1 Therapies

COCKPI-T
Start date: October 2023
Phase:
Study type: Observational

Immunotherapy have revolutionized the field of oncology, but response rates are low and all patients relapse, due to cellular and soluble immunosuppressive mechanisms. These immunosuppressive mechanisms will be better characterized and their involvement in therapeutic responses in non-small cell lung cancers (NSCLC). Indeed, large transcriptomic analysis of different subsets of immunosuppressive cells will performed, correlating them to clinical outcome in a cohort of stage III disease, treated by radiochemotherapy and immunotherapy as maintenance, and stage IV treated by immunotherapy as first-line treatment. Furthermore, we will analyse cellular mechanisms by in vitro studies, assessing the effect of immunosuppressive cells, provided by fresh tumor samples, on phenotype and functions of lung cancer cell lines. The aim of this study is to better characterize immunosuppressive landscape of NSCLC and mechanisms involved in their protumor functions.

NCT ID: NCT06024226 Not yet recruiting - Lung Neoplasms Clinical Trials

Role of MDSCs and Cancer Stem Cells and Their Cross Talks in NSCLC

MyéloLungSC
Start date: October 2023
Phase:
Study type: Observational

Immunotherapy have revolutionized the field of oncology, but response rates are low and all patients relapse, due to cellular and soluble immunosuppressive mechanisms. MDSC are one of the most important immunosuppressive cells, that also harbour non immunologic functions, favouring cancer invasion. These non immunologic functions of MDSC in lung cancer will be better characterized. Indeed, cellular mechanisms will be analysed by in vitro studies, assessing the effect of immunosuppressive cells, provided by fresh tumor samples, on phenotype and functions of lung cancer cell lines. The aim of this study is to better characterize immunosuppressive landscape of NSCLC and mechanisms involved in their protumor functions.

NCT ID: NCT06024122 Not yet recruiting - Clinical trials for TBI (Traumatic Brain Injury)

Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study

KAOUENN
Start date: September 2, 2023
Phase:
Study type: Observational

Concussions (also known as mild traumatic brain injury) are common in young children. In some children, they can lead to short- and long-term difficulties. However, our knowledge of the exact consequences of injuries on young children's brains and behavior is limited. These consequences may be different in children under 6, as their brains are fragile and undergoing significant developmental changes. The aim of this study is to determine the extent to which a concussion sustained before the age of 6 years is associated with changes in young children's brain structure, function and behaviours, using a brain imaging. In this study, the results of a group of 30 children with a concussion will be compared to those of 30 children of the same age with an orthopaedic injury to the upper or lower limbs.

NCT ID: NCT06019169 Not yet recruiting - Clinical trials for Chronic Heart Failure

Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients

YOG-IC
Start date: August 30, 2023
Phase: N/A
Study type: Interventional

Heart failure (HF) is a chronic disease that has a strong impact on quality of life and is often accompanied by anxiety and depression symptoms that can contribute to poor treatment compliance. The overall management of heart failure is currently part of the recommendations and, alongside drug therapy and electrical devices that can be proposed, lifestyle changes (diet, physical activity) can help improve well-being. and perhaps patient prognosis. Yoga is an ancient practice, known to improve the emotional and physical well-being of individuals. There is no formal medical contraindication to this practice, which can be perfectly adapted to the patient's condition. However, very few patients with heart failure practice yoga. A few randomized trials with small numbers as well as the combined analysis of several studies have shown the benefit of yoga in heart failure. The main objective of the research is to demonstrate the improvement in the quality of life induced by the regular practice of yoga in the management of stabilized chronic heart failure patients. Secondly, we will evaluate the effectiveness of regular yoga practice on improving the clinical condition of chronic heart failure patients.

NCT ID: NCT06018961 Not yet recruiting - Colorectal Surgery Clinical Trials

Study of Postoperative Ileus in Digestive Surgery

IPCID
Start date: November 15, 2023
Phase:
Study type: Observational

Post-operative ileus is a temporary stoppage of bowel function following surgery. Indeed it can occur in 20% of cases during post-operative follow-up of bowel surgery. The absence of resumption of transit can lead to the implementation of specific treatments such as the placement of a nasogastric tube and drug treatments. To date, the definition of this event is not accepted by everyone and is not based on reproducible evaluation criteria. The main objective of this study is to evaluate a score used to date to define postoperative ileus, the IFEED score, and to compare it to the length of postoperative stay.

NCT ID: NCT06018155 Not yet recruiting - Low Back Pain Clinical Trials

Study of the Relation Between the Fat Infiltration of the Multifidus Muscle and the Lumbar Foraminal Stenosis, by 2D and 3D Segmentation

FIMFos
Start date: September 1, 2023
Phase:
Study type: Observational

The aim of this study is to evaluate the correlation between the fat infiltration of the lumbar multifidus muscle and several parameters including the severity of the lumbar foraminal stenosis. The investigators will analyse lumbar MRI of patients previously included in a database of patients suffering from low back pain. Foraminal stenosis, muscle fat infiltration and other imaging lumbar parameters will be studied by 2D and 3D manuel segmentation, semi-automatic segmentation. Correlations between factors influencing the muscle fat infiltration will be studied by univariate and multivariate statistical analysis.

NCT ID: NCT06015737 Not yet recruiting - Clinical trials for Cutaneous Lupus Erythematosus

A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus

LAVENDER
Start date: June 17, 2024
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with cutaneous lupus erythematosus (CLE).