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NCT ID: NCT05590702 Recruiting - CLL/SLL Clinical Trials

French Observational Study of Patients With Chronic Lymphocytic Leukemia Or Small Lymphocytic Lymphoma in Real-World Settings

FOLLOW
Start date: November 11, 2022
Phase:
Study type: Observational [Patient Registry]

Chronic lymphocytic leukemia (CLL) is the most frequent form of leukemia in the Western World. The disease is characterized by the accumulation and proliferation of mature, monoclonal, CD5+ B-cells with specific immunophenotype in the peripheral blood (above 5x109/L), bone marrow and secondary lymphoid organs. Small lymphocytic leukemia (SLL) is characterized by similar tumor cells but without increased lymphocyte count. The management of these patients have considerably changed over the last decade. Indeed, beyond chemo-immunotherapy, multiple targeted therapies have been approved on the basis of phase 2 and randomized phase 3 clinical trials and have subsequently been used in daily practice. The management of patients with SLL is similar to that of those with CLL. In addition to therapeutic advances, the advent of new sequencing technologies has also identified CLL genetic features that are now being incorporated in patient routine evaluation. We here propose to set a large-scale prospective and non-interventional study including patients with symptomatic CLL/SLL with the aim to evaluate the real-world clinical management of these patients and to identify the impact of treatments and therapeutic trajectories on long-term outcome.

NCT ID: NCT05590377 Active, not recruiting - Multiple Myeloma Clinical Trials

A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma

iinnovate-3
Start date: January 26, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The main aim of this study is to determine safety and tolerability of modakafusp alfa given together with daratumumab to find out the best treatment dose. Another aim of this study is to learn more about the characteristics of modakafusp alfa.

NCT ID: NCT05590078 Completed - Anxiety Clinical Trials

Evaluation of Interest of LUMEEN Virtual Reality Headset to Reduce Preoperative Anxiety in AMBulatory Surgery

AMBLUMEEN
Start date: March 21, 2023
Phase: N/A
Study type: Interventional

This study evaluate the interest of Virtual Reality to reduce the preoperative anxiety in patients who undergo to ambulatory surgery. Half of the patients will received the virtual reality program, and the other half will received de common treatment.

NCT ID: NCT05589714 Recruiting - Clinical trials for Retinitis Pigmentosa

Universal Rare Gene Study: A Registry and Natural History Study of Retinal Dystrophies Associated With Rare Disease-Causing Genetic Variants

Uni-Rare
Start date: May 11, 2023
Phase:
Study type: Observational

This is an international, multicenter study with two components: Registry - A standardized genetic screening and a prospective, standardized, cross-sectional clinical data collection - Enrollment is open to all genes on the RD Rare Gene List Natural History Study - A prospective, standardized, longitudinal Natural History Study - Enrollment opens gene-by-gene, based on funding and within-gene Registry enrollment The study objectives are as follows. Registry Objectives 1. Genotype Characterization 2. Cross-Sectional Phenotype Characterization (within gene) 3. Establish a Link to My Retina Tracker Registry (MRTR) 4. Ancillary Exploratory Studies - Pooling of Genes Natural History Study Objectives 1. Natural History (within gene) 2. Structure-Function Relationship (within gene) 3. Risk Factors for Progression (within gene) 4. Ancillary Exploratory Studies - Pooling of Genes

NCT ID: NCT05589675 Enrolling by invitation - Colorectal Cancer Clinical Trials

Evaluation of a New Invitation Procedure to the French Organized Colorectal Cancer Screening Program

KITCOLO22
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

This is a randomized controlled trial comparing the effect on participation rates to colorectal cancer screening between an intervention arm (invitation letter to the screening program including a FIT test with or without prior notification) and a control arm with the standard of care (invitation letter to visit the GP who will deliver the FIT test).

NCT ID: NCT05589597 Recruiting - Clinical trials for Colorectal Cancer Metastatic

EO4010 in Previously Treated Metastatic Colorectal Carcinoma

AUDREY
Start date: June 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Open-label multicenter study

NCT ID: NCT05589220 Recruiting - Smoking Cessation Clinical Trials

Study to Evaluate Music Therapy and Nicotine Replacement Therapy on Craving Related to Smoking Cessation in Students

Start date: November 17, 2022
Phase: N/A
Study type: Interventional

The study is a randomized, controlled trial comparing music therapy associated to NRT versus NRT alone to evaluate the value of music therapy in improving the management of craving among 120 student smokers (18 to 25 years old). This pilot multi-method study will combine the methodology of clinical trials with qualitative techniques used in social sciences to show the interest of a digital music therapy tool, adapted to a young audience.

NCT ID: NCT05589103 Recruiting - Head Trauma Injury Clinical Trials

Mild Head Trauma in the Emergency Room: Assessment of the Risk of Intracranial Hemorrhage in Patients Receving Platelet Inhibitors.

Trauma-Head
Start date: January 1, 2020
Phase:
Study type: Observational

The clinical signs presented by a patient with a mild head injury are highly variable but remain strongly predictive of brain damage. The reference examination for the diagnosis of post-traumatic intracranial hemorrhage is currently the cerebral scanner without injection of contrast medium. Magnetic resonance imaging (MRI) tends to surpass CT in equipped centers, except for suspected bone lesions. The time required to perform brain imaging depends on the patient's clinical condition, comorbidities and treatments. The responsibility of antiplatelet agents in post-traumatic intracranial hemorrhage is currently discussed, particularly with aspirin. The hypothesis is that there is no significant difference in the proportion of intracranial hemorrhage in patients on antiplatelet agents after mild head trauma, in the absence of other factors favoring the occurrence of intracranial hemorrhage.

NCT ID: NCT05588843 Recruiting - Colitis Ulcerative Clinical Trials

Dose-finding Study of SAR443122 in Adult Participants With Ulcerative Colitis

RESOLUTE
Start date: November 25, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo controlled, dose-ranging Phase 2 study. The primary objective is to evaluate the efficacy and safety of SAR443122 compared to placebo in participants with moderate to severe UC. Dose selection for further clinical development will be based on the multiple efficacy, safety and PK parameters. The study consists of 4 parallel arms (3 dose groups of SAR443122 vs placebo) to assess the efficacy and safety of SAR443122 in participants with moderate to severe UC. All participants will receive a total of 52 weeks (a 12-week induction treatment phase and a 40-week maintenance phase) of study treatment, except if treatment should be discontinued per investigator's assessment. At the end of the first 12 weeks of induction treatment, all participants in clinical response or remission will be offered study treatment up to 40 weeks and will continue with the same blinded treatment that was assigned. Participants who do not achieve clinical response or remission at the end of the initial 12 weeks induction treatment will roll over in an open-label treatment arm and will be treated with SAR443122 at the highest tested dose. In addition, participants from the maintenance treatment that lose clinical efficacy at any time up to V10/Week 40 (Week 28 of maintenance) will be offered to roll over in the open-label treatment arm with SAR443122 at the highest dose.

NCT ID: NCT05588700 Not yet recruiting - Clinical trials for Metastatic Testicular Cancer

Impact of a Physical Activity Program to Reduce Long-term Cancer-related Fatigue in Metastatic Testicular Germ Cell Tumor Patients

STARTER
Start date: September 30, 2024
Phase: N/A
Study type: Interventional

Testicular germ cell tumor (TGCT) is the most common malignancy in men between 15 and 40 years. Although TCGT survivors have a good survival prognosis, they suffer from short- and long-term sequelae such as chronic fatigue, psychological disorders, cardiovascular toxicities and second malignancies. The benefits of physical activity (PA) during treatments have been demonstrated in cancer patients to improve quality of life (QoL) and physical fitness and to reduce fatigue. However, few PA programs have been proposed to TGCT patients and their effects on sequelae have not been assessed yet. A growing body of evidence links treatment-related alteration in the gut microbiota to sequelae of cancer survivors, including fatigue and cardiovascular toxicities. Also, PA has been known as a possible modulator of the gut microbiota composition. To date, no study has been conducted to examine how the gut microbiota and its metabolites moderate the effect of PA on fatigue and other late effects in TGCT survivors. The objectives will be to assess the impact of a PA program on fatigue and other sequelae and to investigate how the gut microbiota and its metabolites moderate the associations between PA and sequelae. We will conduct a prospective, multicenter, phase III, randomized controlled trial of a one-year supervised PA program. 236 men with metastatic TGCT and eligible for a first line of chemotherapy will be randomly assigned to either PA intervention or control arm. All patients will benefit from a connected activity tracker and PA recommendations. In the intervention arm, PA will be based on supervised sessions and motivational interviews. The primary endpoint (fatigue) will be assessed at 3 years. The trial will provide novel insights into the impact of PA on fatigue and other sequelae in TGCT survivors with understanding a potential underlying mechanism of gut microbiota. This evidence will support the development of targeted PA guidelines to improve QoL and reduce sequelae in TGCT survivors.