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NCT ID: NCT05919290 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

HN-QUEST: A Study of Head and Neck Imaging Biomarkers

HN-Quest
Start date: July 26, 2023
Phase: N/A
Study type: Interventional

This is a multi arm, single center, investigator initiated study to investigate online adaptive radiotherapy and biomarker development in patients with newly diagnosed HNSCC (Head and Neck Squamous Cell Carcinoma) receiving curative therapy. The study will consist of two prospective arms. In Arm 1 up to 100 HNSCC patients receiving (CT)RT (computed tomography-based radiation therapy) will receive up to weekly non-contrast MRI (magnetic resonance imaging) scans during treatment. Arm 2 consists of two cohorts. In cohort A up to 20 healthy volunteers will undergo non-contrast MRI at two time points. In cohort B up to 53 patients planned to receive curative (chemo) radiotherapy for HNSCC will undergo two baseline MRI scans, one MRI in week 2 and week 4, and final MRI scan 6-8 weeks after completion of treatment.

NCT ID: NCT05918861 Recruiting - Clinical trials for Acute Coronary Syndrome

Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS

dal-GenE-2
Start date: October 3, 2023
Phase: Phase 3
Study type: Interventional

This is a placebo-controlled, randomized, double-blind, parallel group, phase 3 multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. A separate informed consent will be allowed for an initial pre-screening genetic testing. Subjects meeting the AA genotype will then consent to the full study and confirmatory genetic testing as required. Subject enrollment may begin in the hospital and will continue following release from the hospital or may begin following release from hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (up to12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

NCT ID: NCT05918471 Recruiting - Obesity Clinical Trials

PReoperative Very Low Energy Diets for Obese PAtients Undergoing Non-bariatric Surgery

PREPARE
Start date: January 2, 2024
Phase: N/A
Study type: Interventional

The PREPARE Pilot randomized controlled trial (RCT) is a multi-center, parallel, blinded RCT that aims to assess the feasibility of a full RCT comparing preoperative very low energy diets (VLEDs) to standard of care prior to elective non-bariatric surgery for obese patients in terms of overall 30-day postoperative morbidity. Adult patients with body mass indices (BMIs) greater than 30 kg/m2 will be randomized 1:1 to receive 3-weeks of preoperative VLED plus preoperative weight loss counselling or preoperative weight loss counselling alone. This trial will enroll patients to assess recruitment, compliance, and follow-up completion to assess the feasibility of a full RCT powered to assess for differences in 30-day postoperative between VLEDs and standard of care arms.

NCT ID: NCT05918250 Withdrawn - Clinical trials for Relapsed or Refractory Multiple Myeloma

mRNA-2736 for Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

Start date: August 15, 2023
Phase: Phase 1
Study type: Interventional

This study is designed to evaluate the safety and tolerability of mRNA-2736 in participants with RRMM.

NCT ID: NCT05918120 Recruiting - Hypertension Clinical Trials

Screening Using Portable Electronic Recorders for Sleep Apnea in Hypertensive At-Risk Populations (SUPER-SHARP Trial)

SUPER-SHARP
Start date: November 13, 2023
Phase: N/A
Study type: Interventional

Uncontrolled hypertension is associated with an increased risk of heart disease, stroke, and mortality. Obstructive sleep apnea (OSA) is common in hypertension and treatment using continuous positive airway pressure (CPAP) has been shown to effectively lower blood pressure. Despite its clinical significance, OSA remains underdiagnosed in patients with hypertension, because the current standard of care to diagnose OSA is in-laboratory polysomnography, which is inconvenient and often inaccessible for high-risk populations. An alternative to in-laboratory polysomnography is home sleep apnea testing, which has been validated against in-laboratory polysomnography and may be more convenient, accessible, and potentially cost-effective. The objective of this study is to compare home sleep apnea testing to in-laboratory polysomnography in a randomized controlled trial. The investigators will assess whether the use of home sleep apnea testing, compared to use of in-laboratory polysomnography, leads to higher rates of OSA diagnosis and treatment using CPAP, a reduction in blood pressure, improved sleep-related outcomes, and greater patient satisfaction among patients with hypertension at 6 months. The investigators will also assess whether home testing is cost-effective.

NCT ID: NCT05917509 Active, not recruiting - HIV Infections Clinical Trials

A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy

VOLITION
Start date: July 6, 2023
Phase: Phase 3
Study type: Interventional

This is a multicentre study carried out in participants living with human immunodeficiency virus type 1 (HIV-1) who have not previously been treated with any antiretroviral therapies. The study will investigate two 2-drug regimens for the treatment of HIV-1: a fixed-dose combination oral tablet of dolutegravir/lamivudine (DTG/3TC) and cabotegravir plus rilpivirine long-acting agents (CAB + RPV LA). All participants will initially receive DTG/3TC once daily, and once virologic suppression is attained (plasma HIV-1 <50 c/mL), participants will be offered a choice to switch to CAB + RPV LA or to continue taking oral DTG/3TC. This study will provide important data on the efficacy, safety, implementation effectiveness, and patient-reported outcomes of these two regimens in a study where participants have the option to choose between them based on individual preference. The aim of the study is to evaluate the antiviral effectiveness at 11 months after switching to CAB+RPV LA following initial virologic suppression on DTG/3TC and to provide data on how long it takes participants to suppress their viral load on DTG/3TC.

NCT ID: NCT05917223 Recruiting - Nutrition, Healthy Clinical Trials

The Impact of Plant-based Blends on Skeletal Muscle Protein Synthesis Rates in Older Adults

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

Lifestyle interventions such as physical activity and dietary habits are the most effective non-pharmacological strategies to combat the loss of muscle mass and the development of mobility limitations with aging. Resistance training (i.e., strengthening exercise) provides a strong stimulus to build muscle mass, and protein provides the essential building blocks. Therefore, an individual's dietary practices can influence the effectiveness of an exercise program - when combined, they work together to increase the muscle-building response. However, not all proteins are equally effective at bringing about muscle growth. Therefore, the purpose of this study is to investigate the effect of a higher-quality plant-based protein blend with lifting weight on muscle building in older men and women.

NCT ID: NCT05917132 Recruiting - Obesity, Abdominal Clinical Trials

Production of Gut Microbiota-Derived Metabolites in Response to Different Fatty Acid Profiles

METAc
Start date: June 12, 2023
Phase: N/A
Study type: Interventional

The proposed project mainly aims to investigate the microbial processes leading to dietary metabolites production, independently of long-term microbiota adaptation to the diet, by measuring the microbiota-derived metabolite production from a meal sequence rich in saturated fatty acids (SFA) or the same meals but rich in polyunsaturated fatty acids (PUFA) in individuals with or without obesity and Type 2 diabetes (T2D)

NCT ID: NCT05916339 Recruiting - Clinical trials for Autism Spectrum Disorder

Management of ADHD in Autism Spectrum Disorder

Start date: October 1, 2023
Phase: Phase 4
Study type: Interventional

This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists. Findings from this study will help improve clinicians' approach to medication selection and reduce the repeated trials of multiple medications that are current standard care.

NCT ID: NCT05915806 Active, not recruiting - Child Development Clinical Trials

Enteral High-dose DHA Supplementation on Bronchopulmonary Dysplasia in Very Preterm Infants: a Collaborative Study

Start date: July 30, 2023
Phase: N/A
Study type: Interventional

This one-stage individual participant data (IPD) meta-analysis study will aim to determine whether high-dose docosahexaenoic acid (DHA) enteral supplementation during the neonatal period is associated with the risk for severe bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age (PMA) compared to control, in contemporary cohorts of preterm infants born at less than 29 weeks of gestation. The association between high-dose DHA and severe BPD will also be explored in important subgroups according to sex, gestational age, small-for-gestational age and mode of delivery.