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NCT ID: NCT06307652 Recruiting - Clinical trials for Heart Failure and Impaired Kidney Function

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

BalanceD-HF
Start date: April 12, 2024
Phase: Phase 3
Study type: Interventional

This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.

NCT ID: NCT06307431 Recruiting - Clinical trials for Renal Cell Carcinoma

A Study of Adjuvant V940 and Pembrolizumab in Renal Cell Carcinoma (V940-004)

Start date: April 10, 2024
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to compare V940 plus pembrolizumab to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator. The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to DFS.

NCT ID: NCT06306716 Recruiting - Chronic Wounds Clinical Trials

Single Center Clinical Study on New Negative Pressure Wound Therapy Dressing in the Management of Chronic & Acute Wounds

Start date: May 30, 2024
Phase:
Study type: Observational

The purpose of the study is to evaluate the clinical performance of a new Negative Pressure Wound Therapy dressing in the management of chronic and acute wounds.

NCT ID: NCT06305767 Recruiting - Bladder Cancer Clinical Trials

A Study of Pembrolizumab (MK-3475) Plus V940 in Participants With Bladder Cancer Post-Radical Resection (V940-005)

Start date: March 28, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of V940 in combination with pembrolizumab (MK-3475) compared to pembrolizumab alone as an adjuvant treatment for participants with pathologic high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection. The primary study hypothesis is that V940 in combination with pembrolizumab results in a superior disease-free survival (DFS) as assessed by the investigator compared to pembrolizumab alone in participants with high-risk MIUC after radical resection.

NCT ID: NCT06303765 Recruiting - Stroke, Acute Clinical Trials

Evaluating the Practice Resource for Driving After Stroke

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

After stroke, individuals must be assessed to determine if they can resume driving. Return to driving is very important to people who have experienced a stroke. Unfortunately, health care providers face challenges in addressing driving after stroke. Common issues include being unsure of the best screening practices, difficulty discussing driving with patients, and challenges making informed recommendations about driving that balance the risk of public safety along with supporting patient goals. Occupational Therapists (OTs) are health care providers that provide screening, assessment, and intervention for driving to individuals who have had a stroke. OTs working in stroke care have highlighted the urgency for evidence-based resources to support practice to address driving with patients. The Practice Resource for Driving After Stroke (PReDAS), is an evidenced-based resource to support the clinical practice of OTs in addressing driving in acute stroke settings. A previous pilot study has demonstrated that the PReDAS is considered useful by both health care providers and patients. Further study is needed to evaluate how the PReDAS can support OTs in addressing driving with patients. The current study proposes to provide the PReDAS as an intervention to OTs working in acute stroke settings to see if the intervention increases OT's self efficacy and clinical reasoning for addressing driving. The study will take repeated measures of self-efficacy and clinical reasoning among participating OTs to determine if the PReDAS intervention supports improved self-efficacy and clinical reasoning.

NCT ID: NCT06299787 Recruiting - Clinical trials for Major Depressive Disorder

Cognitive Dysfunction in the Addictions Study - Project 4 (P4)

CDiA-P4
Start date: February 7, 2022
Phase: N/A
Study type: Interventional

The prefrontal cortex, although well established as an efficacious target for the treatment of major depressive disorder (MDD), has recently come into favour as a therapeutic target for alcohol use disorders (AUD). Depressive symptoms are also highly prevalent in individuals with AUD. A number of cognitive and psychological processes stemming from the prefrontal cortex, a common treatment target for repetitive transcranial magnetic stimulation (rTMS), are disrupted in both MDD and AUD. The proposed study will enhance the development of theta burst stimulation (TBS) as a new intervention for AUD in the context of depressive symptoms and uses integrated TMS-EEG to identify neurophysiological targets of executive dysfunction in this disorder.

NCT ID: NCT06299514 Recruiting - Heart Failure Clinical Trials

RAFT-P&A Randomized Control Trial

Start date: April 25, 2024
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some elderly patients find it difficult to tolerate medications and suffer the side effects of such treatments. In those instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker. A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). However, this has not been directly compared to BiVP in a robust randomized control trial. There is also not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of BiVP to CSP in patients who undergo AV node ablation for treating AF, in addition to comparing both pace and ablate methods to pharmacological therapy.

NCT ID: NCT06297226 Recruiting - Multiple Myeloma Clinical Trials

Study of BMS-986393 a GPRC5D-directed CAR T Cell Therapy in Adult Participants With Relapsed or Refractory Multiple Myeloma

QUINTESSENTIAL
Start date: March 21, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effectiveness and safety of BMS-986393 in participants with relapsed or refractory multiple myeloma.

NCT ID: NCT06295484 Recruiting - Preterm Birth Clinical Trials

Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants

Start date: August 21, 2021
Phase: N/A
Study type: Interventional

Background: In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to collapse. This support commonly done by CPAP and Non-Invasive Positive Pressure Ventilation (NIPPV) therapy by giving some pressure and oxygen to their lungs through an interface placed on their noses. Both (CPAP and NIPPV) can be used as a support modality for respiratory distress syndrome, apnea of prematurity, and providing breathing support after extubation from the full mechanical breathing support. The CPAP supports the baby's immature lungs by delivering constant pressure to keep their lungs and breathing well supported. Whereas the NIPPV will use constant pressure in the background (similar to CPAP), and on top, it will give extra intermittent puffs at regular intervals to support the baby's breathing. The NIPPV is the most common choice by the clinicians when the traditional CPAP is no longer effective, to avoid the full mechanical breathing support and to protect the developing lungs. Studies suggested that NIPPV is better than the traditional CPAP in reducing the need of the baby to need full mechanical breathing support. This might be because the investigators tend to use lower pressures with CPAP (5-8 cmH2O) compared to relatively higher pressures with NIPPV. More recently, clinicians showed the safety of using equivalent higher CPAP pressures (>9 cmH2O) to what the investigators use in the NIPPV in preterm babies. One way to measure the support that the investigators are giving to the patient with the different devices is to measure the diaphragm activity, which the investigators call the Edi signal, using a special feeding catheter and a specific machine to measure it. The catheter is placed and used as a routine feeding tube but has sensors at the end to measure this Edi signal. One opening of the tube will be connected to a computer to record the Edi signals. The other opening of the tube will be used for feeding.

NCT ID: NCT06294067 Recruiting - Nutrition, Healthy Clinical Trials

A Dose Response Investigation of Docosahexaenoic Acid (DHA)

DRI-DHA
Start date: February 26, 2024
Phase: N/A
Study type: Interventional

Docosahexaenoic acid (DHA) is an omega-3 polyunsaturated fatty acid (n-3 PUFA), commonly consumed from fish, that regulates many critical functions within the body including the brain, eye, and heart. While the metabolic precursor to DHA, alpha-linolenic acid (ALA) is considered nutritionally essential and has a set Dietary Reference Intake (DRI), DHA has not yet been deemed essential and does not have a set DRI. Currently, research suggests an intake range of dietary DHA to be anywhere from 0 to over 500mg/d. The aim of our study is to further investigate a feedback mechanism or accumulation that occurs with eicosapentaenoic acid (EPA) as a result of increased dietary DHA to provide insight for potential Recommended Dietary Intake (RDI) values. Hypothesis: The dietary DHA dose at which blood EPA levels increase is the point at which elongation slows, indicating a significant negative feedback pathway is present. Objectives: 1: To determine the dose-response for DHA to increase blood EPA levels in a mixed vegetarian and vegan population. 2: Investigate the DHA dose and time at dose that increases EPA using natural abundance delta carbon-13 (δ13C) as a tracer. 3: To measure DHA turnover and loss rates. 4: Provide data for exploratory analyses related to PUFA metabolism and the effect of DHA on disease related biomarkers. Method: During an 8-week trial, 72 healthy vegan or vegetarian males and females (18-50 years) will be supplemented with 1 of 6 algal-oil based DHA doses: 0, 100, 200, 400, 800 or 1000 mg/d. Blood will be collected at days 0, 3, 7, 14, 28 and 56 and will be analyzed for changes in blood EPA levels as the primary outcome and plasma δ13C EPA signature as the secondary outcome. Significance: Investigating this negative feedback pathway is of great importance in providing evidence to support n-3 PUFA DRIs. EPA and DHA are ecologically sensitive with their major source coming from unsustainably farmed fish stocks and having a set DRI may help to limit the overconsumption of these nutrients.