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NCT ID: NCT06402240 Recruiting - Depression Clinical Trials

The Pocket Skills Adjunct Project

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

This study aims to provide access to an adjunct intervention alongside standard group DBT services to examine feasibility, acceptability, and potential added efficacy of the adjunct. The adjunct intervention is an online tool based on DBT skills training and was already evaluated as a self-guided intervention. Participants will complete a baseline session and be given immediate access to the adjunct intervention. Participants will be followed for 12 weeks and complete assessments every 4 weeks.

NCT ID: NCT06399822 Recruiting - Clinical trials for Undifferentiated Connective Tissue Diseases

Impact of Capillaroscopy on the Management of Undifferentiated Connective Tissue Disease

Start date: May 22, 2024
Phase: N/A
Study type: Interventional

Connective tissue diseases (CTD) are a group of diseases with diverse manifestations, most often multisystemic, which share an autoimmune etiology. They include Systemic lupus erythematosus (SLE), Systemic sclerosis (SSc), Sjögren's syndrome (SS), Inflammatory myopathies (IM) and Mixed connective tissue disease (MCTD). Many patients in rheumatology present signs and symptoms of CTD, but without meeting all the classification criteria for one of these diseases. These patients will generally receive a diagnosis of undifferentiated connective tissue disease (UCTD). It is increasingly suggested that there are two subgroups of patients with UCTD: one which will eventually evolve into a better characterized CTD (approximately 30% of patients at 5 years) and another with a more benign prognosis. The optimal management of patients with UCTD is not clearly established. Capillaroscopy is a diagnostic test used in the investigation of patients with CTD. It is a low-cost, non-invasive, rapid and specific test in the evaluation of this class of diseases. Its role is now well established in the diagnosis of SSc and in the investigation of Raynaud's phenomenon. In addition, capillaroscopy helps to identify patients suffering from CTD more quickly. Knowledge about the role of capillaroscopy in UCTD is more limited. It is established that a significant proportion of patients with UCTD present abnormalities on UCTD present non-specific abnormalities and 11% present a scleroderma pattern. In these patients, abnormal capillaroscopy seems to increase the risk of progressing to a better characterized CTD, notably SSc. However, although capillaroscopy is increasingly used in rheumatology in patients with CTD, more research is needed to clarify the role of this examination in UCTD. First, it is not established whether capillaroscopy should be performed in all patients with UCTD, nor when exactly it should be performed. There also remain questions about the impact of capillaroscopy on the prognosis and management of patients with this disease. To our knowledge, there is no prospective study that has addressed this question. The investigators hypothesize that in patients with UCTD, capillaroscopy compared to usual care makes it possible to increase the proportion of patients obtaining a diagnosis of better characterized CTD in the first six months of follow-up.

NCT ID: NCT06399575 Recruiting - Hypoxia Clinical Trials

Characterizing Hypoxic Apnea Intra-individual Repeatability

CHAIR
Start date: May 2, 2024
Phase: N/A
Study type: Interventional

Apneas (breath-holds) are increasingly being tested in human subjects to understand how the human body operates. Apneas decrease heart rate and increase blood pressure. These findings are driving current research into the effects of oxygen concentrations on the heart rate and blood pressure responses to apneas and the effect of breath-hold training on these responses. The interest in apnea research is three-fold: 1. Apneas are a nervous system stressor that can help researchers better understand the fundamental operation of the human body; 2. Elite divers can use findings from research to better their training and performance; and 3. The scientific understanding of apneas may translate to a better understanding of sleep apnea. Despite this interest, little is known about the repeatability (the consistency within a single day) and reproducibility (the consistency between days) in the heart rate and blood pressure responses to apneas. This uncertainty limits the scientific interpretations from previous results. This study aims to determine the repeatability and reproducibility of heart rate and blood pressure responses to apneas. The goals of the study are: 1. To provide greater certainty to previous results; and 2. Inform best practices for future studies. The study requires 20 healthy volunteers (10 females) and will measure heart rate, blood pressure, breathing parameters (expired gas concentrations, breathing volume and rate), and oxygen saturation. During the protocol, participants will complete two maximal voluntary apneas and five test apneas. The test apneas will all be the same length based on the longer of the two maximal voluntary apneas. Before each apnea, participants will also breathe low oxygen concentrations (hypoxia). Hypoxia provides a bigger decrease in heart rate during apneas than room air which makes it easier to see changes in heart rate responses between apneas (i.e., bigger signal-to-noise ratio). Participants will complete two identical test sessions on back-to-back days. The differences in heart rate and blood pressure responses to the five apneas within each session will determine repeatability and the differences between sessions will determine reproducibility. The investigators hypothesize that repeatability will be good and that repeatability within a session will be better than reproducibility between sessions.

NCT ID: NCT06399393 Recruiting - Multiple Myeloma Clinical Trials

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

KarMMa-9
Start date: October 16, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

NCT ID: NCT06398665 Recruiting - Clinical trials for Post-Concussion Syndrome

Accelerated, Theta-burst Stimulation for the Treatment of Post-concussion Syndrome - Open-label Pilot Study

Start date: April 29, 2024
Phase: N/A
Study type: Interventional

The current study aims to better understand the efficacy of intermittent theta-burst stimulation (iTBS) treatment in patients diagnosed with post-concussion syndrome (PCS) and to explore changes in brain networks after undergoing iTBS to assess its safety and feasibility in treating PCS.

NCT ID: NCT06398548 Recruiting - Exercise Training Clinical Trials

Impact of Exercise Intensity on Fitness, Extracellular Vesicles, Inflammation, and Metabolism

CEX
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Introduction This study investigates the effects of different intensities of indoor cycling on various health measures. Participants will perform a maximal cycling test to determine their maximal fitness - a strong predictor of overall health - before and after a 6-week training intervention. Blood samples will also be obtained to look at various physiological markers related to extracellular vesicles, inflammation, and metabolism. Who can participate? Healthy young adults who between 18 and 40, are free of immune disease, with a normal body mass index can join this study. They will be divided into three groups: - One group will ride a bike at a moderate pace. - Another group will ride a bike at a slightly harder pace. - The third group won't change their usual daily activities and will continue living as they normally do. What does the study involve? Each exercise session aims to burn a specific amount of calories: 350 for males and 300 for females. Participants cycle 3 times a week for 6 weeks. At the end, we'll repeat the bike test and take another blood sample to see if there have been any changes due to the exercise. Why is this research being done? The researchers want to see how different intensities of exercise impact health and fitness. This may help people make better choices about how much and what type of exercise they should do. What happens after the study? Researchers will analyze the data from the study and see if any differences exist between the protocols. If the participant is interested, we will also provide their blood test results, and the results from their max test.

NCT ID: NCT06396065 Recruiting - Clinical trials for Non-Squamous Non-small Cell Lung Cancer

Phase III Study of AK112 for NSCLC Patients

Start date: May 4, 2023
Phase: Phase 3
Study type: Interventional

A Randomized, Double-blind, Multi-center, Phase III Clinical Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Progressed on or Following Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment (HARMONi)

NCT ID: NCT06395948 Recruiting - Atopic Dermatitis Clinical Trials

A Study Evaluating APG777 in Atopic Dermatitis

Start date: April 29, 2024
Phase: Phase 2
Study type: Interventional

This is a two-part study that will evaluate the safety and efficacy of APG777 in participants with moderate-to-severe Atopic Dermatitis (AD). Part A will evaluate the safety and efficacy of one induction dose regimen of APG777 compared to placebo. In addition, two maintenance regimens will be evaluated in Part A. Part B will evaluate the benefit-risk of 3 dose regimens of APG777 compared to placebo. One maintenance regimen will be evaluated in Part B. The study duration for any individual participant will be up to 106 weeks which includes: screening, induction, maintenance, and post-treatment follow-up periods. Participants randomized in Part A are not permitted to participate in Part B.

NCT ID: NCT06393712 Recruiting - Clinical trials for Cerebral Amyloid Angiopathy

A Phase 2 Trial of ALN-APP in Patients With Cerebral Amyloid Angiopathy

cAPPricorn-1
Start date: May 2024
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the effect of ALN-APP on measures of CAA disease progression and to characterize the safety, tolerability, and pharmacodynamics (PD) of ALN-APP in adult patients with sporadic CAA (sCAA) and Dutch-type CAA (D-CAA). The study will be conducted over 2 periods: a 24-month double-blind treatment period and an optional 18-month open-label extension (OLE) period. The estimated duration of study participation, inclusive of screening, treatment, and additional safety follow-up, is up to 50 months.

NCT ID: NCT06392438 Recruiting - Dry Eye Clinical Trials

Cyclosporine and Intense Pulsed Light for Dry Eye in Contact Lens Users

CycliP
Start date: April 25, 2024
Phase: Phase 3
Study type: Interventional

In this study, two treatments typically used for dry eye disease will be tried for contact lens users to see if their symptoms when they use their contact lenses get better. Cyclosporine is a drop that is used for long-term management of the inflammation and Intense pulsed light (IPL) is a treatment done in a clinic to improve the health of the eyelid glands. The main question in this study is: Does the combined treatment of cyclosporine and IPL improve the symptoms and the dry eye signs of contact lens wearers? All the participants will receive the cyclosporine drops for 4 months twice a day. The research team will split the group of participants in two, half receiving the real IPL treatment and half receiving a sham IPL treatment during the last two months of the study. This will allow to compare the two groups to see how IPL helped. The dry eye tests will be done at the start of the study, after two months and after 4 months. The tests will include a dry eye symptoms questionnaire, measures on the tears, the structures of the front of the eye and the eyelids.