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NCT ID: NCT05952037 Recruiting - Clinical trials for Waldenstrom Macroglobulinemia

Study to Evaluate the Efficacy and Safety of BGB-11417 in Participants With Waldenström's Macroglobulinemia

Start date: September 28, 2023
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety and efficacy of the BCL2 inhibitor BGB-11417 in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) in 3 cohorts.

NCT ID: NCT05951920 Recruiting - COVID-19 Clinical Trials

Lymph Node Aspiration to Decipher the Immune Response of Beta-variant Recombinant Protein Booster Vaccine (VidPrevtyn Beta, Sanofi) Compared to a Bivalent mRNA Vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in Adults Previously Vaccinated With at Least 3 Doses of COVID-19 mRNA Vaccine.

LymphoBOOST
Start date: July 5, 2023
Phase: Early Phase 1
Study type: Interventional

In order to investigate whether a germinal center response occurs following vaccine boost and to characterize it based on the type of vaccine received, we aim to analyze Spike and/or RBD-specific germinal center B cells within the draining lymph nodes. To achieve this, we will perform lymph node fine needle aspiration of the draining lymph node in 6 subjects in each study arm, 3 to 6 weeks after the booster vaccine injection.

NCT ID: NCT05951764 Recruiting - Anesthesia Clinical Trials

Prediction Models for Cardiovascular and Neurocognitive Disease Risk in the General Population

CME
Start date: May 2024
Phase:
Study type: Observational

More accurate and earlier identification of people at risk of cardiovascular disease (CVD) and neurodegenerative diseases (memory, cognition, dementia) through the appropriate use of biomarkers could lead to earlier initiation of preventive therapies and potentially avoid sometimes fatal events and complications. Biomarkers are useful for determining the risk of disease, but also for establishing a diagnosis. High inter-individual variability hinders the establishment of general laws that can be- used in predictive medicine. In addition to the lack of validation, other limitations are the low participation rate in screening campaigns (regardless of disease) and the relative difficulty, accuracy, cost and time taken to perform the measurements. The perioperative period is a very good time to screen for cardiovascular and neurodegenerative pathologies for several reasons: - Patients come to their anesthesia consultation and to the operating room because they have a direct visible benefit. - the physiological data collected intraoperatively during systematic monitoring are very "rich" and of very good quality because they are not very noisy - The induction of general anesthesia or the onset of locoregional anesthesia and its maintenance represents a strong and reproducible physiological "test" for the cardiovascular and cerebral systems. - The patients are regularly re-examined postoperatively for the follow-up of their pathology and the possible complications are recorded in their file, allowing a short and medium term follow-up. The project aims to validate a biomarker predictive of cardiovascular complications, the pulse wave velocity, and a biomarker predictive of cognitive disorders, the power of the Alpha wave on the electroencephalogram, from the data usually collected during each anesthesia and during the perioperative period. The objective is to build a predictive model of cardiovascular and neurodegenerative risks, possibly combined, on a survival analysis.

NCT ID: NCT05951478 Recruiting - Clinical trials for Primary Ciliary Dyskinesia

DCP (RaDiCo Cohort) (RaDiCo-DCP)

DCP
Start date: May 2, 2017
Phase:
Study type: Observational

Primary Ciliary Dyskinesias (PCD) are rare, autosomal recessive respiratory diseases, due to a defect in mucociliary clearance linked to abnormalities in the structure and/or function of the cilia. The variety of ciliary abnormalities identified reflects the genetic heterogeneity of PCDs. The thirty or so genes currently implicated explain the pathology in about half of the patients. PCDs are characterized by recurrent infections of the upper (rhinosinusitis) and lower (bronchitis) airways, beginning in early childhood and progressing respectively to nasal polyposis and bronchial dilatation. In half of the cases, there is a lateralization defect of the organs (situs inversus) corresponding to Kartagener's syndrome. There is more frequent infertility in men (immobility of spermatozoa) than in women (miscarriages and tubal pregnancies). About a third of patients progress to respiratory failure. The identification of predictive factors of severity, specific to PCDs, would improve patient care. It is also important to assess the quality of life of patients with PCD, particularly at the ENT level. Data from prevalent patients are currently integrated into three separate and complementary databases: the "e-RespiRare" database, the "DCP Cils" database and the "DCP genes" database. The first step is therefore to constitute the RaDiCo-DCP database which will include data from prevalent and incident patients whose diagnosis of PCD is certain. The cohort aims to improve the routine care of PCD patients, in particular by highlighting predictive factors of severity, allowing early and personalized care, to assess the social impact (quality of life) and medical conditions of ENT impairment, as well as adult infertility, to finely characterize the ciliary phenotype. The study also aims to search for new DCP genes and to allow genotype/phenotype correlation studies.

NCT ID: NCT05951452 Recruiting - Endometriosis Clinical Trials

The Developmental Origins of Endometriosis

ENDOHaD
Start date: January 8, 2024
Phase:
Study type: Observational

Introduction: Endometriosis is a common pathology affecting one in 10 women, characterized by the ectopic development of endometrium, which can cause pain and/or infertility. This pathology is primarily determined by hereditary factors, but it is also susceptible to environmental influences, such as the age of the onset of menstruation or exposure to chemical substances that modify the endocrine system. Recent studies have highlighted that endometriosis is more common in women with relatively short ano-genital distances (AGD), and that sensitivity to pain is closely linked to adult levels of testosterone (T) or oxytocin (OT). Aim: The main objective is to compare the anogenital distance (AGD) between two groups of women: one with stage III or IV endometriosis (ENDO +) and another group without endometriosis confirmed by laparoscopy (ENDO -). The secondary objectives are to compare various factors between the 2 groups : - Basal testosterone levels in blood. - Variations in blood testosterone levels before and after a video stimulating empathy. - Basal oxytocin levels in saliva. - Variations in oxytocin levels in saliva before and after an empathy-stimulating video. - Pelvic pain, between D2 and D5 after the start of the menstrual cycle. For the ENDO + group only: - Evaluate patients' quality of life, between D2 and D5 after the start of the menstrual cycle. - Correlate pain experienced over the last 4 weeks with hormonal markers (AGD, T, OT). Methods: Participants in the ENDO+ group will fill in a questionnaire assessing the impact of pain experienced over the past 4 weeks on their quality of life. D0 is defined as the day when participants experience a menstrual bleed before 10 am. All participants will return for project-specific hospital appointment between D2 and D5 after the start of their menstrual cycle to measure T, Sex Hormone-Binding Globulin (SHBG) and OT. During this consultation, the following samples will be taken: - 10mL blood sample - 2mL saliva sample Both samples will be taken at t0 (before watching the video) and t1 (20 minutes after watching the video).

NCT ID: NCT05951296 Recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Investigate Leramistat in Patients With IPF

Start date: August 30, 2023
Phase: Phase 2
Study type: Interventional

To compare the effect of daily oral dosing of leramistat over 12 weeks with placebo in participants aged 40 years or older with idiopathic pulmonary fibrosis (IPF).

NCT ID: NCT05950178 Recruiting - Brain Death Clinical Trials

Validation of the Apnea Test Performed by High-flow Oxygen Therapy in Patients With Clinical Brain Death

APNEAFLOW
Start date: July 10, 2023
Phase: N/A
Study type: Interventional

Brain death is a clinical and paraclinical diagnosis established in a known etiological context. It involves the irreversible destruction of cerebral functions in a beating-heart individual. In the context of organ and tissue donation from a critically ill patient, the clinical diagnosis of brain death is confirmed through a mandatory apnea test. This test is conducted by disconnecting the patient from the ventilator for a duration of 8 to 10 minutes. The test is considered validated when there is no spontaneous respiratory movement and the presence of hypercapnia. Hypercapnia is defined as a PaCO2 (carbon dioxide partial pressure) greater than 60 mmHg or an increase of more than 20 mmHg compared to the pre-ventilator disconnection capnia. These thresholds are meant to provide a strong stimulus to the respiratory centers, objectively confirming the absence of spontaneous ventilation. In practice, the apnea test is performed under CPAP (Continuous Positive Airway Pressure) or by administering oxygen at 6-10L/min through the endotracheal tube. High-flow oxygenation could be a simple alternative for the apnea test during the validation of the clinical diagnosis of brain death while reducing the risk of lung derecruitment and compromising organ viability and/or lung donation. However, due to the high gas flow used (60 L/min), high-flow oxygenation can lead to a "washout" effect in the anatomical dead space, which may lower the carbon dioxide partial pressure. Consequently, even in a patient in a state of brain death, where spontaneous ventilation is absent by definition, it is not certain that the carbon dioxide partial pressure will increase to the threshold of 60 mmHg or more than 20 mmHg in 10 minutes during an apnea test conducted with high-flow oxygenation. The purpose of this study is, therefore, to examine the feasibility of clinically diagnosing brain death through an apnea test performed with high-flow oxygenation. To determine whether the validation criterion which involves observing an arterial capnia > 60 mmHg or an increase > 20 mmHg (compared to the capnia at the beginning of the test) after 10 minutes can be achieved during an apnea test conducted under high-flow oxygen therapy in patients with clinically confirmed brain death by standard apnea test (under standard oxygen therapy)

NCT ID: NCT05950022 Recruiting - Tendinopathy Clinical Trials

Clinical Improvement Obtained by Endoscopic Ilio-Psoas Tenotomy (Lesser Trochanter Versus Acetabular Notch)

ETIPIC
Start date: December 19, 2023
Phase: N/A
Study type: Interventional

The purpose of the study is to assess Oxford Hip Score at baseline, at 2 months and at over 12 months.

NCT ID: NCT05949814 Recruiting - HIV Infections Clinical Trials

Acceptability of a PrEP Program Among MSM and Transgender (TG) and Having Accepted a Targeted Screening for HIV, Hepatitis B (VHB), Hepatitis C (VHC) and STIs.

Easy-Tests
Start date: July 30, 2023
Phase:
Study type: Observational

Acceptability of a PrEP program among MSM and TG visiting a geolocated community application or a community physical place of sociability and having accepted a targeted screening for HIV, Hepatitis B, C and STIs.

NCT ID: NCT05949684 Recruiting - Clinical trials for Myelodysplastic Syndromes

ELEMENT-MDS: A Study to Compare the Efficacy and Safety of Luspatercept in Participants With Myelodysplastic Syndrome (MDS) and Anemia Not Receiving Blood Transfusions

ELEMENT-MDS
Start date: October 24, 2023
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare the efficacy and safety of Luspatercept vs epoetin alfa in the treatment of anemia in adults due to IPSS-R very low, low, intermediate-risk MDS in ESA-naïve participants who are non-transfusion dependent (NTD).