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NCT ID: NCT05333250 Not yet recruiting - Fatigue Clinical Trials

Modafinil to Improve Fatiguability

MODIFY
Start date: April 2024
Phase: Phase 3
Study type: Interventional

Cancer-related fatigue (CRF) and cancer-related cognitive impairment (CRCI) are among the most commonly reported disabling symptoms experienced by patients with advanced cancer. However, there are currently limited evidence-based pharmacologic interventions available. The investigators will conduct a Vanguard Randomized Clinical Trial (RCT) to estimate the effect of modafinil in managing CRF and CRCI, and to test the feasibility of carrying out the study.

NCT ID: NCT05346913 Not yet recruiting - Depression Clinical Trials

ICBT Program for Caregivers of Persons With SCI

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

Spinal cord injuries have a devastating effect on individuals incurring the life changing event; however, the injury can also affect those who are integrally involved in their care. Assisting individuals after an SCI frequently falls on unpaid, family caregivers. Studies have reported that caregivers experienced significantly greater negative outcomes than positives. The most common negative outcome factors were high levels of burden, poor adjustment to role, decreased QOL, emotional distress, and strain on relationships. Burden of care was also associated with lower levels of functioning of the care recipient, demonstrating the integral relationship between those who provide care and those who receive it. Considering their importance in maintaining their care recipient's wellbeing post-injury, caregivers require ongoing support as a central part of the wider healthcare system. Numerous caregivers are unprepared to handle the responsibilities of their role and lack specialized training to efficiently cope with the burden. Guided internet-delivered CBT (ICBT) offers an accessible and flexible approach for psychosocial service delivery in the community. Evidence for the effectiveness of ICBT has been reported in various populations. The results from our study provide evidence for the potential of guided ICBT to improve psychosocial outcomes among those with SCI. Enhancing the overall wellbeing of the caregiver has previously been shown to improve outcomes of those with SCI. However, evidence for the acceptability and effectiveness of an ICBT approach among caregivers is lacking; as a first step, we plan to conduct a feasibility study of ICBT for SCI caregivers.

NCT ID: NCT05425615 Not yet recruiting - Stroke Clinical Trials

Language Processing and TMS

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

This study will examine the effect of TMS on people with stroke and aphasia as well as healthy individuals.

NCT ID: NCT05472961 Not yet recruiting - Healthy Clinical Trials

Eye Movements in Visual Search

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

Using a noninvasive eye tracker, the investigators will measure how participants move their eyes to objects arrayed on a computer screen. Participants will be asked to find one element among many.

NCT ID: NCT05513456 Not yet recruiting - Critical Illness Clinical Trials

Ethnic and Gender Based Admittance Patterns in the ICU

EGAP-ICU
Start date: April 2024
Phase:
Study type: Observational

The dominating proportion of patients in the ICU are men. Studies indicate that men receive more mechanical ventilation, vasoactive drugs, renal replacement therapy, invasive monitoring and have longer length of stay in the ICU. These differences do not unambiguously translate into a survival benefit for men; if survival would be altered if women were admitted to ICU in the same extent is unknown. Factors affecting ICU admission include age, co-morbidities, physiological parameters (indicating severity of the acute illness) and, additionally, the number of available ICU beds. Factors that should not affect ICU admission include patient gender or ethnicity. This study aims at studying if bias against women and people of certain ethnicities exist. Do clinicians have differing thresholds for ICU admission due to non-medical reasons? The investigators propose testing this hypothesis using a blinded randomized factorial survey study.

NCT ID: NCT05514470 Not yet recruiting - Clinical trials for Interstitial Lung and Liver Disease

Impact of Mutations in Aminoacyl tRNA Synthetases on Protein Translation and Cellular Stress

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

Mutations in the genes encoding cytosolic aminoacyl-tRNA synthetases are responsible for early-onset multisystemic diseases including to varying degrees interstitial lung disease, liver damage, neurological and digestive disorders, and systemic inflammation. These are rare and severe diseases whose pathophysiology is poorly understood. The investigative team hypothesizes that mutations within these genes are responsible for a decrease in protein translation and lead to a cellular stress response similar to that induced by amino acid deprivation. The investigative team also hypothesizes that these alterations could be corrected by high-dose supplementation in the culture medium of the corresponding amino acid. The main objective of the study is to precisely determine the consequences of cytosolic aminoacyl-tRNA synthetase mutations at the cell level on protein translation.

NCT ID: NCT05516472 Not yet recruiting - Kidney Stones Clinical Trials

Fecal Microbiota Transplantation in Kidney Stone Patients

FMT IND
Start date: April 2024
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to measure the impact of Microbial Transplant Therapy (MTT) on 24-hour urine parameters in recurrent hypercalciuric and hyperoxaluric kidney stone formers.

NCT ID: NCT05608993 Not yet recruiting - Acute Otitis Media Clinical Trials

RELAX: Reducing Length of Antibiotics for Children With Ear Infections

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

The overarching goal of this study is to evaluate the effectiveness and implementation outcomes of two low-cost interventions of different intensities to increase prescribing of recommended short antibiotic durations for acute otitis media (AOM) for children 2 years of age and older. A multi-center cluster randomized controlled trial using a hybrid type 2 implementation effectiveness design will be used to evaluate interventions. The High-Intensity intervention will include clinician education, individualized clinician audit and feedback with peer comparison, and electronic health record (EHR) changes of prescription fields, whereas the Low-Intensity intervention will include clinician education and EHR changes. In total, 46 community-based clinics and/or urgent care centers across two distinct geographic regions in the United States will be randomized to one of the two interventions. The Practical Robust Implementation and Sustainability Model (PRISM) will be used to guide implementation and the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework will be used to evaluate outcomes. A mixed-methods approach will be used in the pre-implementation and evaluation phases and will utilize quantitative analyses, semi-structured interviews, focus groups, surveys, and cost analyses. National stakeholders at the American Academy of Pediatrics and the Centers for Disease Control and Prevention will assist with dissemination of findings and scaling of interventions.

NCT ID: NCT05611346 Not yet recruiting - Dermatitis Clinical Trials

HYPNOsis in the Management of Atopic Dermatitis in Children and Teenagers

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

Atopic dermatitis (AD) is a chronic inflammatory dermatosis, common in children. It causes pruritus and skin lesions that can have a significant impact on patients' quality of life. AD can be difficult to treat because of its chronicity, demanding local care, corticophobia and the financial cost of non-reimbursed products. Patients are often looking for therapeutic alternatives. Medical hypnosis is a therapeutic alternative via hypnoanalgesia induced by direct suggestions of comfort and skin soothing and via anxiolysis, by working on stress management and self-esteem reinforcement. Four studies are interested in its action in AD and seem to show a reduction in pruritus, skin pain, an improvement in the intensity of atopic dermatitis, sleep, mood and for some a cure of AD. These results are encouraging but limited by the absence of a control group or by the small population included. Therefore, we propose in a first step to evaluate the feasibility of an hypnosis program through a pilot study, designed in the miniature format of a future, larger scale, randomized controlled trial.

NCT ID: NCT05620914 Not yet recruiting - Clinical trials for Brain Metastases, Adult

A Window of Opportunity Study of Patritumab Deruxtecan in Patients With Brain Metastases

PARAMETer
Start date: April 2024
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to determine if the study drug, patritumab deruxtecan (HER3-DXd), can be measured in brain tumor tissue after recieving one dose of patritumab deruxtecan before surgery.