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NCT ID: NCT06130709 Not yet recruiting - Clinical trials for Hematologic Malignancy

IRAF-ABLATION Study: a Multicenter International Retrospective Cohort of Patients With BTK Inhibitors-related AF Treated by Catheter Ablation

Start date: December 1, 2023
Phase:
Study type: Observational

Targeted anticancer drugs have completely changed the prognosis of malignancies during the past decades. Patients suffering from malignancies live longer and this allows adverse events of anticancer drugs to emerge, notably cardiovascular adverse events. It is particularly important because of the great morbimortality of major cardiovascular events like myocardial infarction or stroke and because of their frequency in cancer populations. Indeed, cardiovascular death is the second cause of deaths after malignancy itself in this population. Atrial fibrillation (AF) is a non rare cardiovascular adverse events associated with a shorter overall survival in some malignancies localization. The emblematic anticancer drugs promoting AF is ibrutinib belonging to the Bruton tyrosine kinase inhibitors (BTKi), which are indicated in hematological malignancies. Incidence of AF with ibrutinib is estimated to 4.92/100 person-years; 95% CI: 2.91-4.81 but is underestimated because of the absence of systematic electrocardiogram recording. The management of AF rests on anticoagulation if indicated by the CHA2DS2-VASc score, and on the choice between a rate or rhythm control strategy. Rate control is the privileged strategy because of the risk of drugs interactions of the anti-arrhythmic drugs in a context of anticancer drugs co-prescriptions. But in case of symptoms with normal heart rate, life expectancy counted in years and preserved condition, catheter ablation has to be discussed. Whereas this interventional procedure has been greatly studied in the general population, no study exists in patients with hematological malignancies. The investigators aim to describe baseline characteristics of a population of BTKi-induced AF undergone AF catheter ablation.

NCT ID: NCT06130605 Not yet recruiting - General Practice Clinical Trials

Subjects Perceived as Embarrassing During a Consultation in General Medical Practice

Gene-MG
Start date: December 1, 2023
Phase:
Study type: Observational

Optimal medical care requires transparency and honesty. However, it is not always easy to address some issues that may be considered too personal, intimate or taboo, such as mental health, sexuality, addiction and death. Patients' approach to these issues may be influenced by the profile of their general practitioner, or by the atmosphere of the consultation. This retention of information by the patient, whether voluntary or not, can lead to adverse events related to care due to a misunderstanding between doctor and patient.

NCT ID: NCT06128083 Not yet recruiting - Obesity, Childhood Clinical Trials

Evaluation of the Impact of Eating Habits on Children's Corpulence

KALI SANTE
Start date: March 2024
Phase:
Study type: Observational

Childhood obesity has been rising steadily over the past 40 years. In 2016, the World Health Organization (WHO) observed around 340 million overweight or obese children and adolescents worldwide, including one in five in France. The causes are complex, both individual (genetic, biological, behavioral) and collective (social, economic, cultural). Childhood obesity encourages the development of chronic diseases such as diabetes and hypertension, and can affect mental health. Without early treatment, the risk of obesity persisting into adulthood is high. In the Alpes-Maritimes region, the commune of Mouans-Sartoux has been promoting a local diet in line with PNNS-4 recommendations since 2011. We wish to study the impact of these actions on the health of Mouans children. We propose a preliminary observational study to assess the relationship between family adherence to PNNS recommendations and the prevalence of overweight and obesity in Mouans-Sartoux elementary school children.

NCT ID: NCT06126588 Not yet recruiting - Meningioma Clinical Trials

Combination of Everolimus and 177Lu-DOTATATE in the Treatment of Grades 2 and 3 Refractory Meningioma: a Phase IIb Clinical Trial

ELUMEN
Start date: October 1, 2024
Phase: Phase 2
Study type: Interventional

Meningioma, the most common intracranial primary tumor of the central nervous system predominantly affects people in their fifties. Meningiomas are generally subdivided into two entities: a priori non-aggressive meningiomas (grade 1), and meningiomas at high risk of aggressive behavior (grade 2/atypical and 3/anaplastic). The current conventional treatments for meningioma are surgery and radiotherapy. When these treatments are no longer feasible, meningiomas are considered refractory irrespectively of grade, and in these rare entities, the therapeutic arsenal is reduced to the few treatments that have shown limited efficacy. Refractory, and particularly grades 2 and 3 meningiomas, have very poor prognoses with a progression-free survival at 6 months (PFS-6) of 26%. The European Response Assessment in Neuro-Oncology group (RANO) recommends that in any new, grades 2 and 3 meningioma, therapy that achieves a PFS-6 >30% in phase II trials be considered promising. In Nuclear Medicine, Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE, currently used on a compassionate basis in refractory meningioma, deploys an octreotide-like effect, and appears very promising, with preliminary PFS-6 of 94% and an overall survival at 12 months (OS-12) of 88% in grade 1 meningioma. However, its PFS-6 is reduced to 28% with an OS-12 of 65% in WHO grades 2 and 3 meningioma. Recently the non-radiolabeled octreotide and everolimus combination however achieved a PFS-6 of 55% and an OS-12 of 75% in a population of 90% WHO grades 2 and 3 meningioma.

NCT ID: NCT06124859 Not yet recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

Exercise Tolerance and Lower-limb Muscle Power in Patients With Chronic Respiratory Disease

VTEP
Start date: November 2023
Phase: N/A
Study type: Interventional

The aim of this study is to validate the six minute Stepper Test (6MST) and the 5-repetition chair lift test (5STS) as measures of exercise tolerance and muscle power, respectively, in patients with chronic respiratory disease. As the reproducibility of the tests has been studied and validated in previous studies, the objective is to investigate the validity of the 6MST and 5STS in comparison with their respective gold standards.

NCT ID: NCT06121050 Not yet recruiting - Clinical trials for Intensive Care Patients

Can a Patient in Intensive Care be Visited by His or Her Pet?

ACCOMPAGNE
Start date: May 2024
Phase: N/A
Study type: Interventional

Nearly half of all intensive care patients describe symptoms of anxiety and depression after a stay in the ICU, and one in five has genuine post-traumatic stress disorder. As a result, improving patient experience has become a priority in the ICU, and particular attention is being paid to the need to recreate a familiar environment. Animal-mediated interventions have been developed for a number of patients over many years. These strategies are widely used with elderly patients, and patients with cognitive or psychiatric disorders, for whom the literature shows benefits on anxiety, mood or objective signs of stress. In the vast majority of experiments carried out to date, the animals (mainly dogs) were prepared and educated for contact with patients, and their handlers trained in this activity, rather like guide dogs. Visiting a care facility with a patient's own pet is rarely described. It may run up against obstacles related to the animal's behavior or infectious risks, but it is nevertheless authorized in many establishments.

NCT ID: NCT06119594 Not yet recruiting - Chronic Disease Clinical Trials

Contribution of the Evaluation of Body Composition by Connected Scale in the Effectiveness of a Reconditioning Program Through Physical Activity Adapted for Patients Suffering From Chronic Diseases

COCORAPA
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The goal of this interventional study is to evaluate the impact of the use of a connected impedance scale on the physical and mental quality of life of patients suffering from chronic diseases and participating in a physical activity rehabilitation program. The main objective is to know if a regular monitoring of the evolution of body composition parameters recorded by the connected scale would allow patients participating in the Physical Activity rehabilitation program at Hôtel-Dieu to follow in real time the effects of such program, not on weight itself but on body composition, and that this would contribute to a better perception of physical and mental quality of life at the end of the program 90 Participants will be randomized in two groups : - Control group (N = 45) : routine care - Interventionnal group (N=45) : routine care + use of connected scale All participants will undergo physical activity rehabilitation program during 6 weeks. Patients will be see again at 6 months, and the following parameters will be comparer between the two groups : - SF-36 questionnaire - Ricci & Gagnon questionnaire - 6MWT - 30 sec sit-to stand test - Ito-Shirado test - Sorensen test - Handgrip test - MaxV02

NCT ID: NCT06118281 Not yet recruiting - Cardiovascular Risk Clinical Trials

ARTEMIS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With a Heart Attack

ARTEMIS
Start date: June 25, 2024
Phase: Phase 3
Study type: Interventional

The research study is being done to see if ziltivekimab can be used to treat people who were admitted to hospital because of a heart attack. Ziltivekimab might reduce development of heart disease, thereby preventing new heart attacks or strokes. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). Which treatment participants get is decided by chance. The chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study will last for about 2 years.

NCT ID: NCT06117943 Not yet recruiting - Clinical trials for Pregnant Women's Tabacco Exposure

Pregnant Women's Knowledge of the Active and Passive Smoking Effects on Pregnancy and the Fetus

tabac-GO
Start date: December 1, 2023
Phase:
Study type: Observational

There are two remaining areas where the standards for tobacco use during pregnancy have changed little: one area is the high level of consumption by pregnant women and the other is the limited care given to pregnant women. Indeed, many pregnant women are still over-exposed to tobacco, either through personal use or passive exposure to cigarette smoke. This passive exposure often comes from the consumption of their loved ones, such as their future co-parent or family. However, throughout our lives, health professionals, associations, and the government send a lot of information and messages about the negative effects of tobacco on health, pregnancy, and the fetus. This information and the possibility of receiving help from a professional trained in tobacco use exist throughout the entire pregnancy. However, many women and their partners still do not take the necessary precautions to reduce or stop smoking. Do couples who smoke during pregnancy really have an understanding of the smoking's effects on women and their fetuses? Could they realize it and would they reduce or stop their consumption, in case they knew these negative effects?

NCT ID: NCT06117696 Not yet recruiting - Prostate Cancer Clinical Trials

Optimizing the Announcement of Advanced or Metastatic Prostate Cancer Using Animated Videos (CartDiag PROSTATE)

CartDiagPROST
Start date: March 2024
Phase:
Study type: Observational

In hospitals, the standard prostate cancer announcement system is based on oral and written information. To improve this system, we have developed animated videos that retrace the patient's care path. This is an exploratory, controlled, before-and-after, multicenter study designed to assess the effect of a standard announcement system reinforced by animated videos on patients' level of understanding of prostate cancer diagnosis and treatment. Patients' perception of information will be assessed using the EORTC QLQ-INFO25 questionnaire.