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NCT ID: NCT05232071 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus

LEGEND
Start date: June 29, 2022
Phase: Phase 2
Study type: Interventional

The study in the T2DM population is intended to confirm the lanifibranor effect versus placebo on glycemic control and assess a positive effect of the combination of lanifibranor with an SGLT2 inhibitor on glycemic control.

NCT ID: NCT05232058 Active, not recruiting - Heart Failure Clinical Trials

FRENCH OBSERVATORY OF ACUTE HEART FAILURE-2

OFICA2
Start date: March 22, 2021
Phase:
Study type: Observational

In 2009, OFICA 1 provided a snapshot of the management of acute heart failure in France. Over the past 10 years, practitioners have observed a change in the profiles of hospitalized patients and it is necessary to specify the evolution of these characteristics, especially since the recommendations concerning management have changed significantly; this is the objective of this observatory. Like patients suffering from chronic diseases such as diabetes or asthma, heart failure patients are therefore at the center of their management. Compliance is improved when patients have understood the reason for the prescription. Ideally, compliance should not be achieved by respecting externally imposed norms, but rather by respecting norms that are understood, adapted, personalized and accepted. A self-questionnaire will thus be given to patients on the day of inclusion in the study. In heart failure patients with an average age of 80 years, systematic screening for cognitive disorders using a simple test recommended by the French National Authority for Health (Haute Autorité de Santé), the codex test, will make it possible to offer more appropriate care if necessary (geriatric or neurology consultation). Finally, follow-up at 3 months and at 1 and 2 years will be carried out by matching with data from the National Health Data System (SNDS)

NCT ID: NCT05228769 Active, not recruiting - Acquired Deafness Clinical Trials

Evaluation of the Quality of Life After a Multidisciplinary Auditory Rehabilitation Program

EQUAPRAP
Start date: December 1, 2021
Phase:
Study type: Observational

In 2008, the Handicap-Santé survey counted 10 million people with hearing difficulties in France, i.e. 16% of the national population. For 5.4 million of these people, the hearing limitations considered to be moderate to total, are likely to have repercussions on their daily life. In 2010, 600,000 people with hearing loss wore hearing aids, including 360,000 with very severe to total limitations who were unable to follow a conversation with others. Hearing loss can impact hearing skills (comprehension in noisy environments or with multiple speakers) and be a source of cognitive decline. It can also limit the quality of exchanges, communication and information taking. Several studies have shown that hearing loss can also have a negative effect on quality of life, psychological well-being, personal fulfillment, social relationships and can lead to social isolation, depression and/or anxiety. Currently, the treatment of people with hearing loss is often limited to hearing aids from a hearing aid specialist. Hearing rehabilitation and lip-reading training with a speech therapist may be offered at a later stage. However, many people who have been fitted with a hearing aid describe a decrease in their quality of life despite the fitting. Current treatment seems to deal mainly with auditory-cognitive problems. To date, no multidisciplinary rehabilitation services seem to be offered in France to take into account the other consequences of this condition: anxiety, depression, and limitations in social participation.

NCT ID: NCT05227183 Active, not recruiting - Clinical trials for Suicidal Behaviour Disorder

Prevention of Suicidal Behavior Through the VIGILANS Protocol: the Restoration of Social Connection Hypothesis

RECONEX
Start date: December 13, 2021
Phase: N/A
Study type: Interventional

The World Health Organization (WHO) estimates, with 800,000 annual deaths, that suicide is the second leading cause of death in people aged 10 to 44 and thus recognizes suicide prevention as a public health priority. The psychological impact of the COVID-19 pandemic, the social isolation and the economic consequences engendered by the confinement, as well as the direct effects of this viral infection increase suicidal mortality. Sensitivity to social rejection in suicide : Epidemiological and clinical studies indicate that social isolation and loneliness are very strongly associated with suicide. Our works suggests that suicide vulnerability is associated with specific processing of social information related to brain regions playing a role in psychological pain and inflammation. In fact, social stresses are powerful inducers of inflammation, also associated with suicide. Thus, we hypothesize that patients at risk of suicide could be particularly sensitive to social adversity (social stress / lack of social support), via the activation of specific brain regions regulating social cognitions, psychological pain and 'inflammation. The VigilanS device: a monitoring tool in suicide prevention. VigilanS is a national telephone recontact system initiated in 2015, which has already shown its effectiveness in preventing suicidal recurrence. Patients admitted to the Emergency Department of the Montpellier and Nimes CHUs for SA benefit from VigilanS monitoring for 6 months (period of major risk). These organized calls aim to assess the patient's condition, manage a possible suicidal crisis and ensure the compromise for discharge from the emergency room. It is important to determine the factors explaining the effectiveness of this device. Thus, we formulate the hypothesis that VigilanS prevents suicidal recurrence by acting on the restoration of the social bond in subjects vulnerable to suicide and isolated. We will test the hypothesis that the preventive effect of the VigilanS device on suicidal recurrence during the 6 months of the day before depends on the sensitivity to social stress of the suicidal patients (measured by the response to an experimental task of social stress).

NCT ID: NCT05226598 Active, not recruiting - Clinical trials for Metastatic Non-Small Cell Lung Cancer

Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

Start date: March 24, 2022
Phase: Phase 3
Study type: Interventional

The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).

NCT ID: NCT05225935 Active, not recruiting - Clinical trials for Ventricular Tachycardia

Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia

InEurHeart
Start date: June 29, 2022
Phase: N/A
Study type: Interventional

This double arm randomized study will compare 2 ventricular tachycardia ablation strategies: the standard strategy based on invasive substrate and VT mapping with 3D electro-anatomical system vs a tailored strategy which identifies targets based on pre-procedural CT-scan imaging. The primary endpoint will be procedure duration and secondary endpoints will include safety and efficacy criteria as well as medico-economic evaluation.

NCT ID: NCT05225675 Active, not recruiting - Clinical trials for Multifocal Motor Neuropathy

A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy

ARDA
Start date: March 31, 2022
Phase: Phase 2
Study type: Interventional

This is a phase 2, randomized, double-blinded, placebo-controlled, parallel-group, multicenter trial to evaluate the safety and efficacy of 2 dose regimens of ARGX-117 versus placebo, in participants with MMN previously stabilized with IVIg (intravenous immunoglobulin).

NCT ID: NCT05224141 Active, not recruiting - Clinical trials for Small Cell Lung Carcinoma

Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008, KEYVIBE-008)

Start date: March 24, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

NCT ID: NCT05222555 Active, not recruiting - Clinical trials for Diffuse Large B Cell Lymphoma

Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients

MINDway
Start date: July 19, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, multicentre study too Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.

NCT ID: NCT05221697 Active, not recruiting - Emergencies Clinical Trials

Effect of an ML Electronic Alert Management System to Reduce the Use of ED Visits and Hospitalizations

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Development, validation and impact of an alert management system using social workers' observations and machine learning algorithms to predict 7-to-14-day alerts for the risk of Emergency Department (ED) Visit and unplanned hospitalization. Multi-center trial implementation of electronic Home Care Aides-reported outcomes measure system among patients, frail adults >= 65 years living at home and receiving assistance from home care aides (HCA).