Clinical Trials Logo

Filter by:
NCT ID: NCT05919498 Recruiting - Breast Cancer Clinical Trials

Realistic Evaluation of a Job Retention Program After Breast Cancer

RECOVA-FTRACS
Start date: January 1, 2023
Phase:
Study type: Observational

Returning to and maintaining employment after cancer is essential for restoring social participation, financial independence and reducing the social costs associated with cancer. Many obstacles that prevent or delay the return to work have been identified. They are associated with the consequences of the disease and treatments such as fatigue, pain and cognitive disorders, the lack of collaboration between health professionals (oncologists, general practitioners and occupational physicians), and the characteristics of the environment. in terms of the demands of the job, and the (lack of) social support from superiors and colleagues. There are social inequalities in the return to work after cancer, with a poorer professional prognosis among older and less qualified people. Social inequalities linked to ethnicity have been documented in other countries. In France, 58,500 new cases of breast cancer are diagnosed each year, half of them in women of working age. The importance of job retention has been formalized in the objectives of the latest cancer plans, and in the 2018-2022 national health strategy. Initiatives are observed to promote this issue by employers: development of a charter by the National Cancer Institute and in the associative field aimed at promoting support practices in their professional environment for people with cancer. Despite the development of descriptive knowledge on prognostic factors for returning to work after cancer, the results of interventional studies are mixed. No intervention has been shown to be effective in facilitating return to work and reducing social disparities in employment after breast cancer. Interventions have been criticized for being too medicalized and lacking a sufficient theoretical basis to analyse causes (theory of the problem) and propose solutions (theory of action). The "FASTRACS" intervention was developed with the Intervention Mapping protocol to facilitate the return to work after breast cancer, it defines a return-to-work path from the hospital to the company through care primaries. This intervention is anchored in primary care with an early transition consultation in general medicine in the month following the end of active treatments (chemotherapy or radiotherapy according to the care protocol). This positioning in primary care allows a bio-psycho-social assessment of the needs of women after cancer. This consultation was designed to establish a plan of care and return to work according to the temporality and individual needs of each woman. It will make it possible to determine the right time for the pre-recovery visit in order to anticipate the professional challenges of the recovery. Return to work/maintenance in employment interventions are complex social interventions, implemented by social actors who act in an environment with which they interact. These interventions (or programs) present an increased risk of failure in their implementation and sustainability. Realistic evaluation comes from the trend of theory-based evaluation (theory-based or theory-driven evaluation). According to this approach, social interventions are based on theories, which can be tested through empirical observation to better understand how and why they produce their effects, and in what context. This approach overcomes the limits of the "black box" model. It is recommended to inform the public decision to interrupt, modify or intensify an intervention. It aims to answer the question: "what works, how, why, for whom, and under what circumstances?" ". It aims to describe the mechanisms of the effectiveness of an intervention by linking its effects to the characteristics of its implementation context (search for CME configurations = context - mechanisms - effects). The search for these configurations, otherwise called "half-regularities" because they can be observed empirically with certain variations, is intended to develop a middle-range theory with a sufficient level of generalization and abstraction. to explain the tendencies and the regularities observed in the interactions contexts-mechanisms-effects of the intervention. This approach is particularly indicated in the evaluation of the FASTRACS intervention, given the complexity of the intervention, the number of actors involved, and the variety of its implementation contexts.

NCT ID: NCT05918302 Recruiting - Clinical trials for Neuroendocrine Tumors

Efficacy and Safety of Radiotherapy Compared to Everolimus in Somatostatin Receptor Positive Neuroendocrine Tumors of the Lung and Thymus.

LEVEL
Start date: October 27, 2023
Phase: Phase 3
Study type: Interventional

LEVEL trial aims to demonstrate the higher efficacy of 177Lu-edotreotide over everolimus in patients with well to moderately differentiated neuroendocrine tumors of the lung and thymus who require systemic therapy. It is hypothesized that 177Lu-edotreotide may significantly increase the progression-free survival (PFS) compared to everolimus in lung and thymic carcinoids.

NCT ID: NCT05918003 Recruiting - COPD Clinical Trials

Actimetry Protocol in COPD Patients

Start date: January 1, 2023
Phase:
Study type: Observational [Patient Registry]

Recently, the principal investigator published an EI predictive Machine Learning algorithm based solely on clinical data, without any physical activity measures, collected from 1 409 patients. The GOLD standard of EI was defined on the basis of interrogation criteria. Patients considered as EI reported walking less than 10 minutes per day on average, and the pulmonologist judged that the patient had mainly "domestic activities". Despite the subjective nature of the GOLD standard, the algorithm validated on a test sample had an error rate of only 13.7% (AUROC: 0.84, CI95% [0.75-0.92]). In the total study population (n=1409), 34% of patients were ultimately classified as EIs by the algorithm, in agreement with the results of studies using actimetry as the GOLD standard. The principal investigator now wish to verify and improve the validity of the MLA on a new smaller population of 104 patients, using a physiological GOLD standard such as three-dimensional actimetry.

NCT ID: NCT05917561 Recruiting - Vitiligo Clinical Trials

Efficacy and Tolerance of the Association of ANIFROLUMAB (300mg) IV Every Four Weeks and Phototherapy Versus Phototherapy in Adults With Progressive Vitiligo

VITANI
Start date: December 15, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this phase 2 study is to evaluate the effect and the safety of the combination of ANIFROLUMAB in combination with phototherapy in adult participants with non-segmental progressive vitiligo

NCT ID: NCT05917405 Recruiting - Clinical trials for Acute Myeloid Leukemia in Remission

Study Comparing the Efficacy of 2 RIC Regimens (Clofarabine vs Fludarabine) in Adults With AML Eligible to Allo-SCT

FLUCLORIC
Start date: September 14, 2023
Phase: Phase 2
Study type: Interventional

Relapse remains the main cause of death in patients with myeloid malignancies, especially after an allotransplant. Using drugs with higher anti-leukemic activity as part of the conditioning regimen is one of the strategies to decrease relapse incidence in this population. Retrospective studies have shown that clofarabine can achieve impressive results compared to the use of fludarabine in acute myeloid leukemia (AML) as part of the conditioning regimen. Confirming such results in a prospective manner would definitely establish the CloB2A2 as a superior reduced-intensity conditioning (RIC) regimen compared to the FB2A2 for AML patients.302 AML patients (151 in each arm) in complete remission at transplant will be included with the main objective to demonstrate a significant better 2-year overall survival for CloB2A2 cases (70% vs 55%). A cost-utility analysis and a cost-effectiveness analysis will be also performed as well as an assessment of the quality of life after transplant. Clofarabine will be furnished to all centers. The duration of the study will be 5 years with 3 years of inclusion and 2 years of follow-up for each patient.

NCT ID: NCT05917327 Recruiting - Clinical trials for Hepatolenticular Degeneration; Wilson

Performance and Safety of MEX-CD1 Low-volume Continuous Veno-venous Haemodialysis Medical Device for Copper-extraction in Patients With Wilson's Disease

MEXWILS
Start date: January 24, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the MEX-CD1 hemodialysis medical device in patients suffering from Wilson's Disease. The main questions it aims to answer are: - Does the device work as expected by removing the excess of free copper from the blood? - Is the device safe when used according to the instructions for use? Depending on the severity of their symptoms, patients will receive either 5 or 10 treatments on consecutive days with the MEX-CD1 hemodialysis medical device.

NCT ID: NCT05916638 Recruiting - Tuberculosis Clinical Trials

MoMa Signature During Granulomatosis

MOSAR
Start date: January 15, 2024
Phase:
Study type: Observational

Sarcoidosis is a systemic inflammatory disease characterized by unspecific granuloma formation. Our hypothesis is that granuloma formation and maintenance mainly relies on the overactivation of monocytes (Mo) and macrophages (Ma). To this end, the study aims (i) to define MoMa systemic signature in sarcoidosis, (ii) to characterize this signature in situ on tissue samples, and (iii) to identify causative factors that participate to the MoMa chronic overactivation. Thus, a cohort of sarcoidosis patients will be compared with tuberculosis patients. The MoMa systemic signature will be defined on whole blood (TruCulture model) and then in situ through different methods (multi-parameter spectral flow cytometry, RNA-seq, Luminex, imaging mass cytometry). The epigenome of monocytes will be studied thanks to CUT&Tag. The MoMa systemic signature will be defined ex vivo at different time points during the course of the disease with phenotypic, transcriptomic, cytokine and functional approaches. The previously identified signature will be studied in situ and completed by the characterization of granuloma architecture and microenvironmental interactions, which could be modulated by epigenetic modifications. Hence, the epigenome of monocytes will be analyzed in two groups (sarcoidosis and tuberculosis). These results would allow to better understand sarcoidosis physiopathology and, in fine, may raise new therapeutic strategies. Finally, the study could challenge the dogma on innate immunity/auto-inflammation versus adaptive immunity/auto-immunity/memory.

NCT ID: NCT05916625 Recruiting - Parkinson Disease Clinical Trials

Exploratory Study of the Expression of the Serotonergic 5-HT4 Receptor in Parkinson's Disease

PARK 5-HT4
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The research aim to study in detail the motor, cognitive and affective modifications of Parkinsonian patients (compared to control subjects) at a moderate stage of the disease and to analyze by positron emission tomography (PET) imaging with the specific radioligand [11C]SB207145 the expression levels of this 5-HT4 receptor. At the same time, the study will monitor the impact of the 5-HTTLPR polymorphisms of Serotonin Transporter (SERT) and Brain-derived neurotrophic factor (BDNF) Val66Met on the expression of the 5-HT4 receptor in subjects.

NCT ID: NCT05916287 Recruiting - Clinical trials for Cardiovascular Diseases

FAMILY INHERITANCE, GENE-GENE AND GENE-ENVIRONMENT INTERACTIONS IN THE FIELD OF CARDIOVASCULAR AND RENAL DISEASES. Fifth Visit of the STANISLAS Cohort

Start date: July 13, 2023
Phase: N/A
Study type: Interventional

The Stanislas Cohort is a monocentric familial longitudinal cohort originally comprised of 1006 families consisting of two parents and at least two biological children and deemed healthy, recruited in 1993-1995 at the Centre for Preventive Medicine of Nancy. This cohort was established with the primary objective of investigating gene-gene and gene-environment interactions in the field of cardiovascular diseases. The 5th visit of the STANISLAS Cohort will allow a better evaluation of the cardiovascular ageing of the population and the transition toward cardiovascular or renal diseases in relation with their genetic profile and environment.

NCT ID: NCT05916079 Recruiting - Breastfeeding Clinical Trials

Breastfeeding Failure: Influence of Smartphone Use and Distraction Factors

BRIEFCALL
Start date: May 2, 2023
Phase:
Study type: Observational

The benefits of breastfeeding no longer need to be proven. Many studies have shown its positives effects on both infants and mothers. Exclusive breastfeeding is thus recommended within the first six months of life. Excessive screen use has been shown to be harmful in many aspects of daily life. The impact upon the relation between mother and newborn infant is poorly studied. The study aims to evaluate the impact of the use of smartphones on the success and duration of breastfeeding.