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NCT ID: NCT06111976 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Repetitive Transcranial Magnetic Stimulation Plus Reactivation Therapy Efficacy on PTSD Symptom Severity in Resistant PTSD

TraumaStim
Start date: March 7, 2024
Phase: N/A
Study type: Interventional

A French multicenter randomized and double blinded shamed controlled study recruiting patients who present resistant PTSD. The aim of this trial is to assess the efficacy of cerebral modulation by rTMS with simultaneous reactivation of traumatic memory on the PTSD symptoms at M1.

NCT ID: NCT06111807 Recruiting - Clinical trials for Lung Cancer Stage III

Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics - Stage III NSCLC

MRD-LUNG
Start date: November 10, 2023
Phase:
Study type: Observational [Patient Registry]

Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies. Currently, for non small cell lung cancer (NSCLC), the methods used to decide who gets additional post radical (surgery or definite chemo-radiotherapy) treatment are suboptimal. Some patients get too much treatment, while others do not get enough. There is a new way to explore if there is any cancer left in a patient's body using circulating tumor DNA (ctDNA) detected in blood samples. This can help decide who needs more treatment. Even though many tests have been developed, it has yet to be determined which test performs best at relevant time points. The GUIDE.MRD consortium is a group of experts, including scientists, technology, and pharmaceutical companies. The consortium is working on creating a reliable standard for the ctDNA tests, validating their clinical utility, and collecting data to help decide on the best treatment for each patient. GUIDE.MRD-03-NSCLC is a part of the GUIDE.MRD project.

NCT ID: NCT06111664 Recruiting - Mood Disorders Clinical Trials

Anergia-anhedonia by Lithium-induced Phosphorus Diabetes

ALIPo-D
Start date: May 1, 2023
Phase:
Study type: Observational

Lithium (Li+) is prescribed to 1‰ of the French population (~ 60,000 patients). More than half of patients describe subjective symptoms linked to Li+ (SSL) similar to those of chronic fatigue syndrome: muscle weakness, fatigability, cognitive disorders, emotional blunting. SSL are the 2nd cause of stopping Li+ (28%), just behind kidney problems (30%). In animals, the administration of lithium (Li+) increases the urinary excretion of phosphate (Pi) by 6, inducing phosphate diabetes (DPi). However, idiopathic forms of DPi explain up to 10-15% of chronic fatigue syndromes and these disappear when supplementing with Pi (± vitamin D). In humans, the introduction of Li+ leads to a reduction in serum phosphate but we have not found any publication on the possible induction of DPi or on a possible link between DPi and SSL. However, the dosages necessary to detect a DPi are carried out during the annual follow-up assessment of patients on Li+. All you have to do is calculate the standardized maximum reabsorption rate of Pi (TmPi) to make the diagnosis! Finally, if the patients presenting with DPi turn out to be the same as those who complain of SSL, we can imagine that correcting the first by simple supplementation with Pi (± vitamin D) could provide relief.

NCT ID: NCT06111586 Recruiting - Clinical trials for Type 1 Diabetes Mellitus

FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS)

FABULINUS
Start date: December 11, 2023
Phase: Phase 2
Study type: Interventional

This is a randomized, parallel group, double-blind Phase 2 study that consists of 2 parts. In Part A the safety of the highest dose-level of frexalimab in adults (age range 18-35 y.o.) will be established. In Part B, a dose-finding study (adolescents and young adults, 12-21 y.o.) evaluating the safety and efficacy of 3 age-adjusted dose-levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on insulin treatment. The purpose of this study is to determine safety and efficacy of different dose-levels of frexalimab, by assessment of preservation of endogenous insulin secretion in participants with newly diagnosed T1D aged 12 to 21 years compared with placebo on top of standard insulin therapy, and to determine the dose-response relationship and minimal efficacious dose in Part B. Study details include: - Screening period: at least 3 weeks and up to 5 weeks (Up to 11 days may be required to get investigational medicinal product [IMP] on site. Enrollment date of the participant must take into consideration this constraint.) - Double-blind treatment period (104 weeks): -- Main treatment period: 52 weeks -- Blinded extension: 52 weeks - Safety follow-up: 26 weeks (not applicable for participants entering the open-label study) The treatment duration will be up to 104 weeks, the total study duration will be up to 135 weeks.

NCT ID: NCT06111248 Recruiting - Clinical trials for All Conditions Requiring Non-cardiac Surgery

Impact of Training on the Use of Software and Digital Monitoring Tools During General Anesthesia for Intermediate/Major-risk Surgery on Morbidity and Mortality at 28 Days

AoA QUALITY
Start date: October 6, 2023
Phase: N/A
Study type: Interventional

Tools such as surgical plethysmographic index, state entropy, train-of-four monitors exist to optimize the conduct of general anesthesia in intermediate and major risk surgery as defined by the 2022 European Society of Cardiology Guidelines on cardiovascular assessment and management of patients undergoing non-cardiac surgery. Although these monitors are available on anesthesia machines they are still under-used by teams due to lack of training, practice and a real understanding of their usefulness (operation, expected benefits). When used in conjunction with General Electric's AoA Carestation Insight software, these tools could have a real impact on morbidity and mortality at 28 days post-op. The aim of this prospective monocentric interventional "before/after" study is to assess the impact of training and encouraging teams to use these tools.

NCT ID: NCT06111105 Recruiting - Clinical trials for Liver Metastasis Colon Cancer

Clinical Validation and Benchmarking of Top Performing ctDNA Diagnostics - Colorectal Cancer

Start date: August 1, 2023
Phase:
Study type: Observational

Improving personalized cancer treatments and finding the best strategies to treat each patient relies on using new diagnostic technologies. Currently, for colorectal cancer, the methods used to decide who gets additional post-surgery treatment are suboptimal. Some patients get too much treatment, while others do not get enough. There is a new way to explore if there is any cancer left in a patient's body using circulating tumor DNA (ctDNA) detected in blood samples. This can help decide who needs more treatment after surgery. Even though many tests have been developed, it has yet to be determined which test performs best at relevant time points. The GUIDE.MRD consortium is a group of experts, including scientists, technology, and pharmaceutical companies. The consortium is working on creating a reliable standard for the ctDNA tests, validating their clinical utility, and collecting data to help decide on the best treatment for each patient. GUIDE.MRD-01-CRC is a part of the GUIDE.MRD project.

NCT ID: NCT06110559 Recruiting - Depression Clinical Trials

Use of tDCS Applied to the Orbitofrontal Cortex to Improve Risky Decision-making in a Clinical Population

tDCSDeMOStim
Start date: April 16, 2021
Phase: N/A
Study type: Interventional

Decision-making is a complex cognitive function that has been the subject of extensive scientific research in the fields of cognitive and computational neuroscience. It relies on a cerebral network that encompasses cortico-subcortical pathways. The orbitofrontal cortex (OFC) plays a significant role in decision-making by assigning values to guide choices. Risky decision-making is observed in several psychiatric pathologies, including depression and bipolar disorder, and it may constitute an endophenotype of suicide. In the project presented here, we propose to use transcranial direct current stimulation (tDCS) to target decision-making in patients suffering from mood disorders.

NCT ID: NCT06110533 Recruiting - Clinical trials for Pulmonary Tuberculosis

Epidemiological Study of Hospitalized Children for Pulmonary Tuberculosis at Strasbourg University Hospitals

TPE
Start date: April 4, 2023
Phase:
Study type: Observational

Pulmonary tuberculosis is the most common form of tuberculosis in children; According to the WHO, tuberculosis pulmonary tuberculosis in children represents approximately 80% of all cases of tuberculosis in children. In 2020, there were approximately 1.0 million new cases of pulmonary tuberculosis among children worldwide. In France, childhood tuberculosis remains a rare disease; the most recent data show a rate of 3.3 cases per 100,000 inhabitants among children under 15 years old in 2019. Pulmonary tuberculosis in children can lead to complications such as bronchiectasis and pneumothorax. Children living in homes where an adult has a active tuberculosis, or children with diseases chronic, malnourished or suffering from HIV are more likely to contract tuberculosis. The aim of this research is to determine the incidence, identify the risk factors as well as the clinical forms of pulmonary tuberculosis in children hospitalized at Strasbourg University Hospitals between 2012 and 2022.

NCT ID: NCT06110507 Recruiting - Clinical trials for Depressive Disorder, Treatment-Resistant

Chronic Anergic-anhedonic Depression Open Trial

CADOT
Start date: April 1, 2023
Phase:
Study type: Observational

A form of depression called 'dopamine-sensitive anergic-anhedonic syndrome is usually resistant to standard therapies (TRAD). On the other hand, they respond to dopaminergic approaches for which recommendations have been developed: DATA ('Dopaminergic Antidepressant Therapy Algorithm'). These are two stages starting with non-selective monoamineoxidase inhibitors (MAOI) or dopamine D2 receptor agonists (D2RAG) in 'monotherapy' (DATA1) and proposing to combine them in the event of a partial response (DATA2). The effectiveness of this approach in the management of TRAD has not yet been evaluated in routine care. The aim of this study is to evaluate the feasibility and effectiveness in routine care of the DATA recommendations in the management of TRAD presenting to a specialized consultation for resistant depression (short and long-term results).

NCT ID: NCT06110403 Recruiting - Copd Clinical Trials

Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness

VARI-OSCIL
Start date: September 29, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Multicentre, prospective, non-randomised, single-arm, open label, mechanistic study to investigate the mechanism of action of BGF 160 on ventilation pattern complexity and variability