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NCT ID: NCT05913752 Not yet recruiting - Clinical trials for Alcohol Use Disorder

A First in Human Study of CMND-100 in Healthy and Alcohol Use Disorder (AUD) Subjects

Start date: April 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this study is to find the tolerable dose and characterize the safety and pharmacokinetics/ pharmacodynamics (PK/PD) of single and repeated dose of CMND-100 in Healthy Volunteers (HV) and Subjects with Binge Drinking/Alcohol Use Disorder (AUD). The secondary objective of this study is to preliminarily evaluate the efficacy of CMND-100 in reduction of drinking patterns and craving in subjects with binge drinking or/and moderate to severe AUD.

NCT ID: NCT05927987 Not yet recruiting - Anxiety Disorders Clinical Trials

Feasibility and Acceptability of Problem Management Plus (PM+) for Prisoners in the Netherlands - a Pilot RCT

PROSPER
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The goal of this pilot randomised controlled trial is to evaluate the feasibility and acceptability of the - specifically to the prison context adapted - World Health Organization's Problem Management Plus (PM+) intervention for individuals detained in Dutch remand prisons. The main question[s] it aims to answer are: - To what extent is the contextually adapted PM+ intervention feasible and acceptable for individuals detained in Dutch remand prisons? - To what extent are there preliminary indications of pre to post-effects of the PM+ intervention on, for example, anxiety and depression symptoms? Researchers will compare two groups to answer these questions. Participants will either receive the PM+ intervention and Care-as-Usual or only Care-as-Usual.

NCT ID: NCT05930756 Not yet recruiting - Chronic Pain Clinical Trials

3-point vs 6-point GNRFA for Chronic KOA

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare three-point and six-point Genicular Nerve Radiofrequency Ablation (GNRFA) in adults with chronic knee osteoarthritis (KOA). The main question it aims to answer is whether six- target GNRFA technique is more efficacious than standard three-target GNRFA technique in managing the pain and function of KOA. Consented patients who respond to a diagnostic block will be randomly assigned to either three-point or six-point GNRFA. Researchers will compare pain and function in these two groups.

NCT ID: NCT05937854 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH

BETTER COPD-PH
Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

The investigators will study whether the drug tadalafil improves shortness of breath in 126 Veterans with Chronic Obstructive Pulmonary Disease (COPD) and high blood pressure in the lungs. The investigators will also assess whether tadalafil improves quality of life, home daily physical activity, exercise endurance, the frequency of acute flares of COPD, blood pressure in the lungs, and lung function. Veterans who enroll in the trial will be allocated by chance to either active tadalafil or an inactive identical capsule (placebo). Neither the Veteran nor the investigator will know whether the Veteran is taking tadalafil or placebo. Veterans will be followed closely in clinic or by telephone at 1, 2, 3, 4, 5, and 6 months, with attention to side effects and safety. At 1,3, and 6 months the investigators will repeat the questionnaires and testing of blood pressures in the lung and lung function. The investigators anticipate that the results of this study will determine whether tadalafil improves shortness of breath when added to usual medications for COPD.

NCT ID: NCT05937906 Not yet recruiting - Clinical trials for Non-Small Cell Lung Cancer

Clinical Trial Evaluating the Safety and Efficacy of Chemoimmunotherapy Plus Short Course of Mek Inhibitor in First Line of Treatment of Metastatic Non Squamous Non Small Cell Lung Adenocarcinoma With PDL1 < 50 %.

IMMUNOMEK
Start date: April 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

Monocentric study composed by 2 steps : 1. First step is a phase I with the aim of establish the recommended dose of mirdametinib administration (2 or 4 mg twice a day for 7 or 14 days per cycle for the 4 first of carboplatin/pemetrexed/pembrolizumab treatment) 2. Second step is a non comparative randomized (2:1) phase II trial testing the recommended dose of mirdametinib administration. The aim is the efficacy and safety of short course of mirdametinib treatment for the 4 first cycles of the carboplatin/pemetrexed/pembrolizumab treatment.

NCT ID: NCT05945355 Not yet recruiting - Obesity Clinical Trials

Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

MICA
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

This is single-center cross-sectional mechanistic study in lean and obese children with moderate-severe asthma, followed by a randomized, SHAM-controlled trial of Inspiratory Training (IT). The primary outcome is to describe the contributions of inspiratory muscle dysfunction (IMD) and Small Airway Dysfunction (SAD) to obesity-related versus non-obesity-related asthma. The study will involve training (IT) for 8 weeks at three intensity levels (SHAM, low and high). Target dose: 150 inspirations three times weekly. The population includes 6 to 17-year-old children with moderate to severe asthma and with a body mass index qualifying as normal habitus (BMI 5th to 84th CDC percentile) or obese habitus (≥95th percentile BMI and less than 170% of the 95th CDC percentile). Participants will be involved for 10 weeks. The investigators will use analysis of covariance (ANCOVA) to estimate and test the difference in mean values of baseline measures between obese and non-obese cohorts. Covariates will include age, sex (male/female), race/ethnicity, baseline asthma severity (NAEPP step 2 vs ≥3), and atopy status

NCT ID: NCT05947955 Not yet recruiting - Clinical trials for Acute Respiratory Distress Syndrome

Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

BTI-203 is a randomized, double-blind, placebo-controlled, multicenter, Phase 2 proof-of-concept (POC) study to evaluate the efficacy and safety of rhu-pGSN plus standard of care (SOC) in subjects with moderate-to-severe ARDS (P/F ratio ≤150) due to pneumonia or other infections. Potential subjects hospitalized with pneumonia or other infections are to be screened within 24 hours of diagnosis of ARDS.

NCT ID: NCT05953454 Not yet recruiting - Clinical trials for Chronic Low-back Pain

Effectiveness of Pain Neuroscience Education on Clinical and Psychosocial Variables in Chronic Low Back Pain

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

An educational intervention on the neurophysiology of chronic pain will be provided. The content of the intervention will be identical in the experimental groups (group and individual). The intervention has an active educational approach based on reconceptualizing the maladaptive beliefs that influence the fear-avoidance behavior of the participants through updated contents of the neuroscience of pain. The effects of the intervention will be compared between the groups and the influence of the social determinants of health on the effects will also be determined. The investigators hypothesize that there will be significant differences in favor of the group intervention group over the individual intervention groups. Furthermore, the effects will be influenced by the social determinants of health in both experimental groups.

NCT ID: NCT05974358 Not yet recruiting - Crohn Disease Clinical Trials

KONO-S Anastomosis Compared to Conventional Ileocolonic Anastomosis to Reduce Recurrence in Crohn's Disease

KOALA
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) currently affecting one person in a thousand in France. It can lead to numerous digestive complications such as fistulas, abscesses or stenosis. Despite numerous therapeutic advances, the rate of patients requiring surgery remains very high, with approximately 50% requiring at least one surgical intervention at 10 years after disease diagnosis. However, surgical treatment is not curative, the postoperative recurrence rate being very high, from 65 to-90% endoscopic recurrence at 1 year. The ileocolonic anastomosis is the main site of postoperative recurrence currently defined by a Rutgeerts score (≥i2) 6 months after surgery. In 2003, Kono et al. described a new operative technique that could reduce the rate of post-operative recurrence: a termino-terminal ileocolonic anastomosis, anti-mesenteric, with a supporting column to prevent distortion and anastomotic stenosis (Kono-S anastomosis). The study showed no decrease in endoscopic recurrence rate at 1 year (83% vs 79%), but a significant decrease in surgical recurrence rate at 5 years (15% vs 0%). Recently, a randomized Italian monocenter study showed a significant decrease in endoscopic recurrence rate at 6 and 18 months (22.2% versus 62.8% and 25% versus 67.4%), as well as a decrease in clinical recurrence. The limitations of this study are its monocentric nature and the lack of centralization of the endoscopic analysis to assess the primary endpoint. This surgical technique has been performed in some centers for ileocolonic Crohn's surgery since 2020. Nevertheless, the level of evidence remains too low to establish practice recommendations. The KOALA study will be the first prospective, multicenter, randomized study comparing KONO-S anastomosis and conventional anastomosis for ileocolonicresection of Crohn's disease, with blinded and centralized evaluation of recurrence.

NCT ID: NCT05977192 Not yet recruiting - Clinical trials for Vaccination Hesitancy

Mobile Health-based Motivational Interviewing to Promote COVID-19 Vaccination

COVID-19
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the preliminary efficacy and acceptability of an mobile Health-based motivational interviewing (MI) intervention to promote SARS-CoV-2 vaccination (MOTIVACC) compared to traditional phone-based MI.