Le Breuil, France

Pediatric Expansion Study of the Sentio System

This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above. It is a prospective, multicentre study sponsored by Oticon Medical AB, which will be conducted at eight hospitals across Europe (UK, Spain and the Netherlands). A total of 50 patients with a hearing loss than would benefit from treatment with a bone-anchored hearing system (BAHS) will be included. Participation is voluntary and the decision to participate must be well-founded and well informed. The Sentio system is a transcutaneous bone conduction hearing system (an implant and an external sound processor) for individuals with certain types of hearing losses. The implant is implanted into the bone behind the ear (mastoid and temporal bone area). After a period of skin healing, a sound processor which transmits sound waves to the implant can be magnetically attached. The implant transforms the sound waves to vibrations, which are then transmitted to the inner ear via the bone. The primary objective of the study is to demonstrate that the Sentio system improves the hearing on the implanted ear, compared with the unaided situation. The study includes eight study visits; one before surgery, the surgery visit, and six follow-up visits, with the last visit taking place 12 months after surgery.

Effects of a Multidisciplinary Intervention on Fall Risk and Urinary Incontinence in Older Women

The aging process can lead to the development of major geriatric syndromes, such as falls and urinary incontinence. Although there are studies demonstrating the effectiveness of physical exercise and education in addressing these conditions, there is currently very limited evidence on the combined effects of both therapies on these syndromes. The primary objective of this study is to evaluate the effects of a multidisciplinary intervention consisting of physiotherapy, physical exercise, and psychoeducation on the risk of falls and urinary incontinence in older adult women. Methods: This will be a quantitative, quasi-experimental, and longitudinal study with 18 weeks of intervention and a 24-week follow-up period. The study is scheduled to begin in January 2025. The sample will consist of non-institutionalized older adult women aged between 60 and 80 years, who will be randomly assigned to one of four groups: 1. A multicomponent exercise group with verbal instructions targeting the pelvic floor. 2. A multicomponent exercise group with verbal instructions targeting the pelvic floor and psychoeducation. 3. A multicomponent exercise group without verbal instructions targeting the pelvic floor. 4. A control group. Multicomponent exercise sessions will be conducted twice a week and will include exercises focused on balance, strength/power using elastic bands, aerobic capacity, and coordination. The verbal instructions for the pelvic floor will involve performing fast and slow contractions during the general exercises. Participants in the psychoeducation group will attend five group therapy sessions throughout the program. The study will analyze variables related to balance (Timed Up and Go test, functional reach test, and posturography), lower limb strength/power (isometric strength tests and jump performance), and pelvic floor function (using the PERFECT scale and electromyography). Additionally, physical, psychological, and social well-being variables will be assessed using instruments such as the SF-36, ICIQ-SF, and Rosenberg self-esteem scale. Results/Conclusion: It is anticipated that differences will emerge between the study groups, with the trimodal intervention group (multicomponent exercise + specific verbal instructions for the pelvic floor + psychoeducation) showing greater improvements in certain parameters.

Six-Month Single-Blind, Placebo-Controlled Study of a Dietary Supplement Supplement on Hair Growth in 45 Volunteers

Nutraceutical foods are those that provide health benefits beyond basic nutrition. These include naturally occurring foods such as fish and vegetables, as well as processed foods like wine, yogurt, and dairy products. These natural compounds or substances exert therapeutic effects on the body, with the term 'nutraceutical' originating from the combination of 'nutrition' and 'therapeutic' The classification of nutraceuticals is diverse and extensive, encompassing isolated nutrients, herbal products, fruit-derived supplements, dietary supplements, genetically modified foods, and processed products such as cereals, soups, and beverages . This diversity has enabled nutraceuticals to be widely available in commercial products spanning the food, pharmaceutical, herbal, and agro-industrial sectors. One area of particular interest in nutraceutical research is hair health. The product to study has been developed to manage acute hair loss and to strengthen hair and nails. Thanks to its composition, including L-Cystine, glutathione, vitamins B5 and B6, copper, and zinc, it helps maintain hair and nail health. A new formulation of the product has been designed specifically to improve androgenetic alopecia (AGA) by incorporating natural ingredients that functionally inhibit the 5α-reductase enzyme. Androgenetic alopecia (AGA) is one of the most common forms of hair loss in both men and women . It is characterized by the miniaturization of hair follicles due to the action of dihydrotestosterone (DHT) on androgen receptors. DHT is derived from testosterone via the 5α-reductase enzyme, which exists in three isoenzymes (types I, II, and III). Type II is most relevant to AGA as it is predominantly found in hair follicles. Many pharmacological interventions for AGA focus on inhibiting DHT's action on the hair follicle. Additionally, various molecules and vitamins are involved in the pathogenesis of AGA and in maintaining the proper cycle and structure of the hair follicle. The rationale for this study is based on the premise that the combination of different natural active ingredients inhibiting the 5α-reductase enzyme can work synergistically to improve signs associated with androgenetic alopecia. Serenoa Repens (Saw Palmetto) Cucurbita Pepo (Pumpkin Seed Oil) Pygeum Africanum Extract L-Cystine Oleanolic Acid Horsetail Extract (Equisetum arvense) This observational study will evaluate the effects of the product in 30 volunteers receiving the active supplement and 15 receiving a placebo. The primary objective is to determine the supplement's effectiveness on hair health, growth, and hair loss over six months through instrumental (TrichoScan HD Professional 4.0) and subjective (questionnaires) evaluations. The study population consists of 45 male volunteers aged 18 to 45 years with hair growth and loss issues. The study will be conducted in compliance with regulatory guidelines, with careful monitoring of any potential adverse effects to ensure the safety and efficacy of the supplement. Given that the key active ingredients in the product of study have established safety profiles and are widely used in commercial products, no significant adverse effects are anticipated. However, continuous monitoring will be conducted throughout the study to ensure participant safety and product efficacy. Volunteers will be compensated accordingly for their participation, and the study will be conducted under strict ethical and legal guidelines.

High-intensity Functional Training on Functional and Cognitive Performance in People with Parkinson's Disease.

The hypothesis is that high-intensity functional training (HIFT), at a motor and cognitive level, provides a greater benefit than conventional programs of strength, balance and cognition, on the functionality and cognitive capacity of people with Parkinson's disease. Overall objective: - To assess whether the HIFT training program is associated with significant improvements in functional and cognitive capacity compared to conventional strength, balance and cognition programs in Parkinson's patients. Secondary objectives: 1. To assess whether the HIFT program improves the quality of life in patients with PD. 2. To study whether the HIFT program reduces the degree of dependency of patients with PD. 3. To determine if the HIFT program improves physical performance in patients with PD 4. To assess whether the HIFT program reduces the risk of falls in patients with PD. 5. To investigate whether the HIFT program improves balance in patients with PD. 6. To determine if the HIFT program improves functional capacity in patients with PD. 7. To study whether the HIFT program improves cognitive function in patients with PD

A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients

A Phase I/IIa open-label, randomised study of oral roginolisib (IOA-244 [roginolisib hemi-fumarate]) in combination with dostarlimab with or without docetaxel in Advanced Non small-cell lung cancer (NSCLC) patients. This study will enrol approximately 45 male and female patients aged over 18 years with advanced NSLCL who have process on standard of care immune checkpoint therapy and platinum doublet chemotherapy or standard immunotherapy without chemotherapy. The disease must be measurable (i.e., at least 1 measurable lesion) as per RECIST v1.1 by Computerised Tomography (CT) scan or Magnetic Resonance Imaging (MRI).

Effects of Functional Exercise Program With Strength Load and Resistance in Children and Adolescents With Cerebral Palsy

This research project is a randomized controlled trial designed to analyze the effects of a functional exercise program with strength and resistance load in adolescents with CP specifically classified at levels III and IV of the GMFCS scale. The study will include around 40 participants aged 10 to 18 years, randomly assigned to either an intervention group or a control group. The intervention group will perform functional exercises with progressive strength and resistance load, adjusted based on heart rate. The control group will perform the same functional exercises but without any load. The protocol includes 36 sessions over 18 weeks, with evaluations at three key time points: before the intervention, at the end of the protocol, and six months post-intervention. The primary outcomes include functional percentile within the GMFCS, quality of life asperceived by patients and caregivers, and participation in daily environments. The study will adhere to CONSORT guidelines and the Declaration of Helsinki and has been reviewed by an ethics committee.

APACE - Feasibility of Using Accelerometers to Measure Physical Activity in Cancer Patients on Early Phase Clinical Trials

An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)

Clinical Epidemiology in Contemporary Patients With Myelofibrosis.

Myeloproliferative neoplasms (MPNs) are rare bone marrow disorders characterized by clonal proliferation of hematopoietic cell lineages, and include polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis (MF). MF has worse prognosis, with main causes of death including acute leukemia transformation, comorbid conditions, and consequences of cytopenia. MF is characterized by progressive anemia, bone marrow fibrosis, and extramedullary hematopoiesis with splenomegaly. Moreover, the disease is associated with a heavy symptom burden including night sweats, fever, bone pain, and weight loss and worsening the quality of life. On the beginning of 2013 the European Registry for Myeloproliferative Neoplasms (ERNEST) observational study was launched and approved by several IRBs of European hematological centers. The study focused on overt Primary (PMF) and Secondary myelofibrosis (SMF; i.e., post-Essential Thrombocythemia myelofibrosis (post-ET MF) and post-polycythemia (post-PV MF)) and aimed at describing the clinical epidemiology of large series of patients observed in clinical practice. This research was justified as the landscape of both pathophysiological and clinical knowledge in MPNs was rapidly evolving, prompting to revise diagnostic criteria, prognostication and therapy recommendations. ERNEST retrospectively enrolled 1292 patients in whom the proposed prognostic models were confirmed to differentiate treatments in clinical practice, while ERNEST-2 reported results on critical events observed in 1010 of these cases during a median follow-up period of 5.4 years.4,5 The two studies closed in December 2022. In the last decade, new diagnostic and prognostic findings have been accumulated and the availability of new approved drugs, based on results of several new clinical trials, influenced the therapy decision making in the real-world clinical practice. Therefore, the continuation of observational studies in present ERNEST-3 on large multicenter case series of patients with MF is timely and might refine the results of clinical trials. The purpose of this study observational retrospective/prospective study is to gain information on MF associated cytopenias that represent a significant challenge in the contemporary patients with MF. Currently, there are few agents aimed at treating cytopenic MF, including immunomodulatory drugs, hypomethylating agents, and JAK inhibitors such as momelotinib and pacritinib, and development of new agents specifically tailored to this patient population remains an unmet need. Therefore, this study can provide data on these patients, focusing on clinical status, quality of life, comorbidities, and treatment results over time.