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NCT ID: NCT05936034 Recruiting - Cancer Clinical Trials

Comparative Study of the Quality of Life of Patients Suffering From OTOTOXICITY Due to Chemotherapy Based on Platinum Salts Fitted With a Hearing Aid Compared to Those Not Fitted.

PROTOTOX
Start date: January 4, 2024
Phase: N/A
Study type: Interventional

There are many undesirable effects associated with platinum-based cancer treatments (renal failure, anaemia, etc.). Their administration also leads to neurosensory problems such as ototoxicity, tinnitus and reduced hearing acuity. According to a the French survey (2018), 39.7% of people suffer from hearing problems due to cancer treatments, five years after a cancer diagnosis. Improving side effects such as hypoacusis and tinnitus can significantly improve patients' quality of life and adherence to treatment. Many clinical trials proposed a medicinal solution to patients receiving platinum-based cancer treatments but none has led to a consensus on management. The aim of the study is to offer patients receiving platinum-based chemotherapy and suffering from hearing problems a hearing aid to improve their quality of life.

NCT ID: NCT05935995 Recruiting - Clinical trials for Squamous Cell Carcinoma of Head and Neck

Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination

HISTOBLOC
Start date: November 28, 2023
Phase: N/A
Study type: Interventional

Study to evaluate the use of confocal microscopy for detecting resection margins in patients undergoing surgery for basal cell carcinoma of skin and squamous Cell Carcinoma of Head and Neck

NCT ID: NCT05935553 Not yet recruiting - Clinical trials for Benzodiazepine Dependence

Baclofen for Improving Benzodiazepine Titration in Benzodiazepine Dependence

BABET
Start date: March 1, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Benzodiazepines and related molecules are among the most prescribed psychotropic treatments in France and Europe. 13.4% of the French population had at least one reimbursement of benzodiazepines in 2015, which places France second in Europe. However, the chronic use of benzodiazepines is a source of numerous complications, particularly addictive. To date, there is no authorized pharmacological treatment for benzodiazepine withdrawal. Baclofen is a gamma-aminobutyric acid (GABA)-B agonist, a pharmacological receptor that regulates GABA-A, the target of benzodiazepines. The pharmacological mechanisms of baclofen are therefore related to those of benzodiazepines. Empirical use outside of the MA has shown that baclofen can facilitate the reduction of benzodiazepines in cases of severe addiction, but this pharmaceutical interest remains to be demonstrated in a comparative study. The main objective of the project is to evaluate the efficacy of baclofen, compared to placebo, in reducing benzodiazepine doses in patients with benzodiazepine use disorder (BUD).

NCT ID: NCT05935228 Recruiting - Clinical trials for Peripheral Venous Access

Development and Evaluation of an Algorithm for Vascular Access Management

ALCOV
Start date: December 5, 2023
Phase: N/A
Study type: Interventional

Two billion catheters are placed annually worldwide. Of all the people requiring vascular access, nearly a quarter have Difficult Intravenous access (DIVA), a source of multiple punctures. The increased risk of haematomas, haemorrhages, infection, pain and associated trauma is responsible for increased human costs and economic impact. To limit the risks posed by the DIVA, practitioners have solutions such as the per-bone line, other types of lines, and placement of peripheral venous catheter with ultrasound or transluminescence. However, these solutions are not always applicable, depending on the care situation (non-substitutable venous access, fragile patient, etc.) or on the technical platform (available personnel and training, configuration of the premises, available equipment). Moreover, these actions are often taken after failures, in a non-anticipated and non-consensual manner. In order to assess the risk of DIVA, F.Van Loon et al developed in 2016, and then modified in 2018, a DIVA Scale (the A-DIVA Scale) which allows a rapid scoring upstream of peripheral venous catheter placement to classify patients according to the risk of DIVA. Composed of five items (non-palpable and non-visible vein, diameter < 3mm, history of DIVA, operator experience) worth one point each, the score allows three categories to be established: "low risk", "moderate risk", "high risk". The study showed that the proportion of first puncture failures increased with the risk of the patients (defined according to the categorized score). The use of a tool such as the A-DIVA Scale is of interest if it allows the definition of actions to be taken in relation to the risk it identifies. In view of this, it appears essential to optimize the management of peripheral venous catheters, particularly for patients with DIVAs. The aim of this study is to develop a graduate and specific response to the issue of multiple punctures. Our project is to create and evaluate a specific algorithm, consisting of a risk assessment (the A-DIVA Scale) and a co-construct decision-making tree (the A-DIVA Tool). Built on the basis of objective clinical data collection and adapted to the possibilities and competencies, this new tool would bring real benefits to the patient in terms of safety (reduction of risks) and comfort (reduction of pain and duration of management), as well as a medico-economic benefit for the institutions. To date, such an algorithm does not exist and its beneficial effects have not been evaluated.

NCT ID: NCT05935098 Recruiting - Solid Tumor Clinical Trials

A Study of BGB-A3055, Alone and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors

Start date: August 21, 2023
Phase: Phase 1
Study type: Interventional

This study aims to test the safety, tolerability, and preliminary anti-tumor activity of BGB-A3055, either alone or in combination with Tislelizumab in participants with advanced or metastatic solid tumors.

NCT ID: NCT05935072 Not yet recruiting - Exercise Clinical Trials

Nutritional Responses to Acute Exercise: Test of the Influence of the Nature of the Meal:

EXHALIM
Start date: July 15, 2023
Phase: N/A
Study type: Interventional

The management of body mass and energy balance requires a better understanding and mastery of the interactions between our daily activities, such as physical exercise, and the control of our food intake. Over the past 15 years, many studies have focused on the potential effects of physical exercise on this satiety cascade and on subsequent food intake, in many populations. Thus, both in normal-weight subjects and in patients suffering from overweight and obesity, it has been shown that the performance of an acute exercise of moderate intensity promotes a transient anorectic effect, reducing feelings of hunger post -exercise, and can even induce a reduction in subsequent food intake. In healthy young adults, recent results show that high-intensity physical exercise can reduce feelings of hunger and increase the satietogenic effect of a meal compared to a control condition and low-intensity exercise. intensity. Nevertheless, it seems that the food reward (which refers to the notion of food reward) does not respond in the same way, the authors not observing any change in either liking or wanting, regardless of exercise intensity. Importantly, this literature uses ad libitum test meals, wishing to assess both satietogenic, hedonic and purely nutritional responses (assessing the amount of food intake). Nevertheless, these sensory and hedonic responses to food intake have recently been shown to be sensitive to the composition of the meal and its caloric quantity, which could induce a significant bias as to the conclusions on the effects of physical exercise. Indeed, the use of meals ad libitum, by definition, leads to caloric intake and different meal compositions. Thus, it is possible that the results obtained are strongly impacted by the nature of the test meal more than by the exercise itself. It therefore remains uncertain today to conclude as to the effects of physical exercise on the factors of the satietogenic cascade, since beyond physical exercise, the test meals compared are not identical. It therefore seems important today to develop a more coherent and adapted methodology, to better study the food and satietogenic responses to our daily activities. In this context, the present project aims to compare the satietogenic response to a meal following acute exercise according to the nature of this meal (ad libitum versus calibrated) in healthy adults.

NCT ID: NCT05935046 Not yet recruiting - Clinical trials for Energy Expenditure, Appetite, Energy Intake, Food Reward Menopause Transition

Effects of Hormonal STatus on Energy Expenditure and Feeding behAvior in woMen(ESTEAM)

ESTEAM
Start date: September 2023
Phase: N/A
Study type: Interventional

The health of women throughout their lives and especially during aging is a subject at the heart of current health issues. Indeed, hormonal variations during a woman's life condition her reproductive life, but also her cardiometabolic health (insulin sensitivity, lipid and inflammatory profile), musculoskeletal health and the maintenance of her mobility. The changes in body composition that occur with age, but also according to hormonal status (Isacco et al. 2021), as well as the metabolic impact of menopause are mechanisms favoring weight gain and more specifically fat mass (Leeners et al 2017). The decrease in estrogen levels during the transition to menopause seems to be the main factor explaining the increase in adiposity, especially visceral, and a decrease in muscle capital. Indeed, estrogens participate in the structural remodeling of muscle tissue as well as in maintaining its oxidative potential (Sutham et al 2018). However, the mechanisms promoting changes in body composition during the transition to menopause remain poorly understood. Better characterizing the energy profile (energy expenditure) and the food profile with regard to body composition in non- and postmenopausal women would make it possible to better target the recommendations for the primary prevention of cardiometabolic alterations linked to ovarian aging.

NCT ID: NCT05934994 Recruiting - Bone Lesion Clinical Trials

Contribution of MUltiparametric Analysis in Bone Scintigraphy for the Characterisation of Solitary Bone Lesions

MUSIC
Start date: September 11, 2023
Phase: N/A
Study type: Interventional

The hypothesis of the study is that non-invasive Single photon emission computed tomography (SPECT-CT) bone scintigraphy makes it possible to better characterize solitary bone lesions, in particular the exclusion of their malignancy in order to avoid unnecessary biopsy and possible complications for the patient.

NCT ID: NCT05934981 Recruiting - Colorectal Surgery Clinical Trials

Laparoscopic Colorectal Surgery Using Low-pressure Combined With Warm and Humidified Carbon Dioxide Insufflation

PAROS3
Start date: August 30, 2023
Phase: N/A
Study type: Interventional

To improve post-operative recovery, medical device was developed combining low-pressure pneumoperitoneum and heated and humidified Carbon Dioxide (95˚F & 95% RH) during laparoscopic surgery to reduce the harmful effects of cold/dry insufflation. A double-blind, prospective, randomized, controlled, monocentric trial is designed in the aim to assess the impact of low-pressure pneumoperitoneum with warm and humidified gaz on post-operative pain at 24 hours without taking opioids. It is compared with low-pressure laparoscopy with cold and dry gaz in patients undergoing colorectal surgeries.

NCT ID: NCT05934929 Not yet recruiting - Clinical trials for Squamous Cell Carcinoma of the Oral Cavity

Contribution of Residual Tumour DNA Testing on the Surgical Bed

MARGINS
Start date: August 1, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the interest of residual tumour DNA research in the operating bed after squamous cell carcinoma excision.