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NCT ID: NCT05218941 Recruiting - Dental Implants Clinical Trials

New IMPLANTARY SURGERY Protocol ASSISTED BY PASSIVE ROBOTIQUE: Pilot Study

NAVIMPLANT
Start date: December 2022
Phase: N/A
Study type: Interventional

The use of a passive robotic system allows the practitioner to widen the field of indications of flapless surgical access to the implant with an increased operative security and the possibility of an operative modification of the surgical protocol.

NCT ID: NCT05218772 Recruiting - Clinical trials for Moderate or Serious Haemophilia

Objective and Perceived Health Status of Elderly People With Moderate or Severe Haemophilia in France: an Ancillary Study of the FranceCoag Registry

SENIORHEMO
Start date: April 19, 2022
Phase:
Study type: Observational [Patient Registry]

Background: Elderly people with serious haemophilia (PwSH), i.e., with moderate or severe haemophilia, have major comorbidities due to consequences of haemophilia. Also, the comorbidities related to age are added. Despite the existence of numerous studies on the objective health status of elderly PwSH, some limitations may be stated (need to update the results in a more contemporary context, no studies conducted in France, highlighted determinants focused on demographic and clinical factors). On the contrary, the perceived health status of elderly PwSH has been little described. Only two studies specifically addressed the quality of life (QoL) of elderly PwSH. These studies reported an altered QoL in some domains, in comparison with reference values from the general population. However, some limitations may also be stated (need to bring results in a more contemporary context, no studies conducted in France, highlighted determinants focused on clinical factors). Since serious haemophilia is a rare disease, studies are often performed on a small number of subjects. The present project relies on the FranceCoag registry, a unique exhaustive national cohort of PwSH followed over time among whom 612 are elderly PwSH. Objectives: Main objective: to describe the objective and perceived health status of elderly (≥60 y.o.) PwSH from of a French exhaustive national registry, and to compare their health status with that of the French general elderly population. Secondary objective: to identify individual (demographic, clinical, social, psycho-cognitive) and collective characteristics (related to healthcare organisation), associated with the objective and perceived health status of elderly PwSH in France. Materials and Methods: A national, multicentric, observational, cross-sectional study will be conducted. It will be based on the participation of elderly PwSH already included in the FranceCoag registry. Each eligible participant will receive a questionnaire to complete concerning: objective health status; perceived health status (QoL assessed by the WHOQOL-Old questionnaire); demographic data; social data; psycho-cognitive data (anxious symptoms, depressive symptoms, use of coping strategies, time perspective). Therapeutic and clinical data related to haemophilia will be collected via the FranceCoag registry database. Data concerning healthcare organisation will be collected directly from investigators of Haemophilia Treatment Centres. The main analysis will consist in the description and comparison of the health status with reference data from the French general elderly population. Standardisation methods will be used to take into account a potential imbalance between the study population and the reference population, related to age and especially to sex, as haemophilia is a predominantly male disease. The secondary analysis will consist in the identification of potential determinants of the health status. Structural equation models will be performed to take into account the complexity of the relationships between the determinants. Impact of the proposal Better understanding the impact of the disease on patients' experience is essential in a systematic global perspective of health, that aims to care and support the individual not only as a patient but also as a person in his/her environment. This study based on a registry will allow to improve the knowledge by updating literature data on the health status of elderly PwSH, adding elements to the rare literature data on the perceived health status, providing data in the French specific context, and identifying both classical and more original determinants of health status of elderly PwSH. These results will be used to better identify elderly PwSH at high risk of poor health status, to propose recommendations and to set up actions to offer them an adapted support, and to elaborate new versions of public health plans dedicated to haemophilia or to rare diseases.

NCT ID: NCT05218655 Enrolling by invitation - Clinical trials for Inherited Mitochondrial Disease

A Safety Study for Previously Treated Vatiquinone (PTC743) Participants With Inherited Mitochondrial Disease

Start date: June 21, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the safety of vatiquinone in participants with inherited mitochondrial disease who had prior exposure to vatiquinone in a PTC/BioElectron sponsored (previously Edison) clinical study or treatment plan. The study will continue until vatiquinone becomes commercially available or the program is terminated.

NCT ID: NCT05218499 Active, not recruiting - Clinical trials for Liposarcoma, Dedifferentiated

Brightline-1: A Study to Compare Brigimadlin (BI 907828) With Doxorubicin in People With a Type of Cancer Called Dedifferentiated Liposarcoma

Start date: March 25, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study is open to people with a type of cancer called dedifferentiated liposarcoma. People with advanced liposarcoma aged 18 or older who are not receiving any other cancer treatment can participate. The purpose of this study is to compare a medicine called brigimadlin (BI 907828) with doxorubicin in people with liposarcoma. Brigimadlin (BI 907828) is a so-called MDM2 inhibitor that is being developed to treat cancer. Doxorubicin is a medicine already used to treat cancer including liposarcoma. During the study, participants get either brigimadlin (BI 907828) or doxorubicin. Every 3 weeks, participants take brigimadlin (BI 907828) as tablets or doxorubicin as an infusion into a vein. Participants can switch to brigimadlin (BI 907828) treatment if they did not benefit from doxorubicin treatment. Participants can continue treatment in the study as long as they benefit from it and can tolerate it. Doctors regularly check the size of the tumour and check whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT05218460 Recruiting - Healthy Clinical Trials

Evaluation of Methodological and Technical DEvelopmeNts to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam on Voluntary Subjects

EDEN
Start date: May 23, 2022
Phase: N/A
Study type: Interventional

The EDEN study will make it possible to evaluate one or more development phases (from design to validation through optimization) of a method or a technique on voluntary subjects, in normal or pathological condition.

NCT ID: NCT05217927 Active, not recruiting - Migraine Clinical Trials

Efficacy and Safety Study of Rimegepant in Episodic Migraine Prevention With Multiple Dosing Regimens

Start date: March 4, 2022
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of daily and every other day dosing of rimegepant to placebo as a preventive treatment for episodic migraine.

NCT ID: NCT05217446 Recruiting - Clinical trials for Metastatic Colorectal Cancer

A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer

SEAMARK
Start date: July 11, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that: - is metastatic (spread to other parts of the body); - has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR) - has a certain type of abnormal gene called "BRAF" and; - has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take encorafenib by mouth at home every day and cetuximab by IV infusion at the study clinic. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.

NCT ID: NCT05217043 Recruiting - Clinical trials for Language Acquisition in the Brain

Language Acquisition in the Brain and Algorithms: Towards Systematic Monitoring of the Evolution of Semantic Representations in Biological and Artificial Neural Networks

SYNTAXE
Start date: July 15, 2022
Phase:
Study type: Observational

Speech depends on our ability to recursively combine successive words into a complex sense. Although the order of these putative operations (syntax) has been the subject of extensive examination in the way in which the human brain learns to perform a "Semantic composition" remains largely unknown. The Rothschild Hospital houses a unit specializing in drug-resistant epilepsy in children from 2 to 20 years old. The identification of the epileptogenic zone often requires making an iEEG recording for a week (implantation of intracerebral electrodes in depth). Sometimes this recording has to be repeated, providing a unique opportunity to directly record brain activity at different periods of its development. Children will listen to pre-recorded phrases and stories such as "The Little Prince of Antoine de Saint-Exupéry" while being recorded with iEEG.

NCT ID: NCT05216835 Active, not recruiting - Clinical trials for Relapsed or Refractory Classical Hodgkin Lymphoma

Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Start date: March 18, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD7789 in patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL).

NCT ID: NCT05216731 Not yet recruiting - Lesion; Femoral Clinical Trials

Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant

PELI-CAN
Start date: March 2022
Phase: N/A
Study type: Interventional

In lower limb peripheral arterial disease, the stage of intermittent claudication has a prevalence of more than 5% over the age of 60, and affects patients who are often still active. Frequent anatomical lesions are strictures / occlusions of the superficial femoral artery. There is a current low level of evidence for the treatment modalities of long lesions (15-25 cm) of the superficial femoral artery and in particular no clinical trial comparing the femoro-popliteal bypass to the endovascular procedure whose patency in retrospective series. appears lower than that of surgery but nevertheless appears in the European recommendations for first-line treatment, with the absence of a dedicated trial being highlighted.