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NCT ID: NCT05878730 Recruiting - Bipolar Disorder I Clinical Trials

Melatonin and Response to Lithium

MeLiR
Start date: July 26, 2023
Phase:
Study type: Observational

Bipolar disorders are mental illnesses characterized by the recurrence of mood-episodes, that can have a severe impact on the life of individuals. The effect of lithium, one of the main medications used to treat acute episodes or prevent them from happening, is very different from one individual to an-other. So far, there is no way to predict in advance for whom patient this treatment will be effective or for whom it will not. Finding markers that can predict as early as possible the efficiency of this treatment is a major field of current research in psychiatry, in order to avoid maintaining an inefficient treatment for several years that can have negative side-effects. Over the past decades, it has been shown by multiple studies that lithium can act on the biological clock, that regulates circadian rhythmicity of the body (i.e. rhythms that presents a 24 hours periods, such as rhythms of sleep and activity, feeding, social activities...). But it is still very unclear whether the effect of lithium in regulating the mood in bipolar disorders is mediated by this action. Melatonin is one of the key-regulator of circadian rhythmicity of the human body. Our hypothesis, based on some previous studies, is that the action of lithium in type-1 bipolar disorder (BD-I) is related to an action on melatonin secretion. To test that, we want in this study to compare the noctunal secretion of melatonin between BD-I individuals with a good response to lithium versus with a poor response to lithium.

NCT ID: NCT05878717 Recruiting - Clinical trials for Scleroderma, Systemic

A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease

BLISSc-ILD
Start date: September 13, 2023
Phase: Phase 3
Study type: Interventional

This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).

NCT ID: NCT05877807 Completed - Clinical trials for Post Traumatic Stress Disorder

Effect of Baclofen to Prevent Post-Traumatic Stress Disorder

BACLO-PTSD
Start date: September 3, 2023
Phase:
Study type: Observational

Considering the results of the Baclorea study (10% reduction in episodes of agitation in intensive care in the Baclofen group), the investigators would like to know whether this reduction in agitation also results in a reduction in the incidence of the syndrome of long-term post-traumatic stress (5 years later). The investigators wish to contact by telephone, blinded from the randomization group as defined in the framework of the Balorea project, by telephone contact, the patients who had been included in the Balorea study between June 2016 and February 2019.

NCT ID: NCT05877755 Not yet recruiting - Cardiac Disease Clinical Trials

Validation of Multi-contrast, High-resolution Cardiac Magnetic Resonance Imaging

CARDIO-IRM
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Cardiovascular disease (CVD) causes at least 1.8 million European deaths annually, exceeding fatalities from cancer, chronic respiratory disease, and diabetes. Consequently, the fight against CVD has become the main priority of the World Health Organization. In the pursuit of understanding and treating CVD, cardiac magnetic resonance imaging (CMR) has remained the only modality capable of providing a comprehensive assessment of the heart's function and structure without harmful radiation. Unfortunately, current CMR systems remain too slow, too complex, require highly trained specialists and, as such, have presented a barrier to a wider adoption of CMR. The aim of CARDIO-IRM is to unleash the full potential of CMR to transform patient trajectories by introducing a fast, one-click, fully automated, and comprehensive imaging pipeline applicable to diagnosis, prognosis, and therapy selection in cardiology.

NCT ID: NCT05877612 Recruiting - Clinical trials for Complex Regional Pain Syndrome Type I

Efficacy of Spinal Cord Stimulation in Burst Mode in the Treatment of Complex Regional Pain Syndromes Type 1 of the Upper Limbs

STIMBURST
Start date: September 12, 2023
Phase:
Study type: Observational

In this study, it is the procedure of spinal cord stimulation in Burst mode, its results and the experience of the patients that are evaluated.

NCT ID: NCT05877547 Recruiting - Clinical trials for Non-alcoholic Fatty Liver Disease

A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)

Start date: June 23, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn how well efinopegdutide works compared to placebo in people who have non-alcoholic steatohepatitis (NASH). Researchers will also learn about the safety and benefit of efinopegdutide and how well people tolerate the medicine. The main goal of the study is to compare how many people taking efinopegdutide or placebo stop showing evidence of NASH without liver scarring getting worse.

NCT ID: NCT05877326 Not yet recruiting - Clinical trials for Post-operative Delirium

Anaesthetic Depth and Short Term Delirium Post Cardiac Surgery Intervention

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

Postoperative delirium (POD) is a critical complication of major surgery and affects up to 70% of surgical patients over the age of 60 years. The additional healthcare costs associated with delirium exceed €50,000 per patient per year due to prolonged hospital stay, increased risk of long-term care or institutionalization, and the risk of developing dementia or cognitive impairment . Therefore, prevention of POD is a major goal in the perioperative setting. The investigator proposes this randomized study to evaluate the interest of a reduced anesthetic depth to prevent short-term cognitive disorders after cardiac surgery in elderly subjects. Method: Patients over 75 years old scheduled to undergo one of the cardiac surgeries of interest (valvular, coronary bypass, aortic or combined surgery) will be randomized to 2 paralell arms : - Perioperative anesthesia with a BIS (Bispectral index) target of 35 - Perioperative anesthesia with a BIS(Bispectral index) target of 55 The presence of mental confusion will be determined by CAM-ICU ( Confusion Assessment Method for the ICU ) at day 3 post procedure. Ancillary study: To assess cognitive status at inclusion, discharge and third post operative month using the MOCA(Montreal Cognitive Assessment ). Conclusion:The hypothesis of this study is that a lower depth of anesthesia will reduce post operative delirium in the first three days in patients older than 75 years who are planned for valvular, coronary artery bypass, aortic or combined cardiac surgery .

NCT ID: NCT05877014 Recruiting - Clinical trials for Humeral Shaft Fracture

Unipolar Versus Bipolar Interlocking in Humeral Shaft Fractures in Adults

UNILOCH
Start date: July 3, 2023
Phase: Phase 3
Study type: Interventional

Shaft fractures account for 20% of humeral fractures and 3% of all adult fractures in France, with an estimated incidence of 13 to 20/100,000 people. Men aged 21 to 30 years and women aged 60 to 80 years are particularly affected. Intramedullary nailing is among the standard treatments for humeral shaft fractures (when surgery is required). Once inserted, the nail is locked in order to limit stress on the fractured bone, as well as possible secondary rotational displacements or malunion. Bipolar interlocking (BI) is typically performed on both sides (proximal and distal) of the fracture site. This procedure is performed under radiological control, exposing the patient and care team to radiation (during the entire procedure). The objective of the treatment is to obtain consolidation of the fracture within 12 months, and to limit the occurrence of irreversible complications such as malunion or nonunion (2-10% at 12 months post-surgery). The "unipolar interlocking" (UI) technique has recently been introduced. In this technique, locking is performed only on the proximal side of the fracture site. By avoiding the distal approach, potential complications such as radial nerve damage, with the risk of irreversible paralysis (3.8-14.2% in studies of the BI technique in this indication) or the risk of infection on the distal side can be avoided. It also reduces operative time, and consequently the radiation received by patients and caregivers. However, the UI may be poorly positioned, resulting in malunion that requires revision surgery. Despite the absence of recommendations due to the lack of existing data, several teams use the UI in routine care. In this context, a descriptive cohort of 121 patients operated on at the Dijon University Hospital5 showed similar rates of consolidation between the 2 techniques (93.8% for UI versus 95.2% for BI, p=0.64), functional scores, and complications, as well as a significant 29% decrease in operating time in the UI group (mean + SD: 63.1±21.3 min versus 88.0±30.1 min for VB, p<0.01). These encouraging results, although limited by the retrospective and observational nature of the data, justify a prospective randomized trial comparing these two techniques.

NCT ID: NCT05876754 Recruiting - Cholangiocarcinoma Clinical Trials

An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma

ProvIDHe
Start date: May 3, 2023
Phase: Phase 3
Study type: Interventional

A Phase 3b research study to consolidate the data that ivosidenib is safe and effective in adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma (CCA). All patients who meet inclusion criteria will be enrolled to receive ivosidenib tablets orally once daily for 28 day cycles, continuing as long as clinical benefit and consent for participation is maintained. There will be a minimum of 6 study visits from screening until the final follow-up, if one cycle of treatment is completed and consent is maintained through 18 months of follow-up. Each additional cycle completed will add one study visit, on the first day of each cycle.

NCT ID: NCT05876468 Recruiting - Evaluable Clinical Trials

Effects of Continuous Anterior Chest Compression

StrapVent
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The aim is to test the physiological effects of continuous anterior chest compression in patients with severe to moderate ARDS.