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NCT ID: NCT06469372 Recruiting - Cardiac Amyloidosis Clinical Trials

Cardiac Amyloidosis Discovery Trial

Start date: May 28, 2024
Phase: N/A
Study type: Interventional

This is a single center, diagnostic clinical trial in which the investigators aim to prospectively validate a deep learning model that identifies patients with features suggestive of cardiac amyloidosis, including transthyretin cardiac amyloidosis (ATTR-CA). Cardiac Amyloidosis is an age-related infiltrative cardiomyopathy that causes heart failure and death that is frequently unrecognized and underdiagnosed. The investigators have developed a deep learning model that identifies patients with features of ATTR-CA and other types of cardiac amyloidosis using echocardiographic, ECG, and clinical factors. By applying this model to the population served by NewYork-Presbyterian Hospital, the investigators will identify a list of patients at highest predicted risk for having undiagnosed cardiac amyloidosis. The investigators will then invite these patients for further testing to diagnose cardiac amyloidosis. The rate of cardiac amyloidosis diagnosis of patients in this study will be compared to rate of cardiac amyloidosis diagnosis in historic controls from the following two groups: (1) patients referred for clinical cardiac amyloidosis testing at NewYork-Prebysterian Hospital and (2) patients enrolled in the Screening for Cardiac Amyloidosis With Nuclear Imaging in Minority Populations (SCAN-MP) study.

NCT ID: NCT06467916 Recruiting - Clinical trials for Post Traumatic Stress Disorder

The Development of PATH, a Program to Support NICU Parent Mental Health Through the Transition From Hospital to Home

Start date: June 15, 2024
Phase: N/A
Study type: Interventional

The objective of this study is to develop and pilot test a telehealth-based mental health screening and engagement program that supports parents as they transition from the NICU to home. The program will use a stepped-care approach to screen parents for depression, anxiety, and PTSD; provide a brief behavioral intervention to those who screen as having at least a low risk of these conditions; and provide a warm hand-off to community mental health services for those at medium to high risk.

NCT ID: NCT06467825 Recruiting - Healthy Clinical Trials

Effect of Sex on Orthostatic Intolerance and Cardiovascular Response During Lunar Descent and Ascent

Lunar OI
Start date: August 9, 2022
Phase: N/A
Study type: Interventional

The purpose of Lunar OI (Orthostatic Intolerance) is to determine if there are differences between males and females in tolerance to and cardiovascular responses during different angles of head-up tilt simulating gravity levels less than or equal to Earth's gravity. Also, this study will determine if a gradient compression garment affects tolerance to tilting and the cardiovascular stress at different tilt angles. Males and females are being identified by biological sex. This will be a two-phased study design. In Phase I we will determine whether there are differences in the development of signs or symptoms of orthostatic intolerance between males and females when tilted head up on a table to different angles to simulate gravity levels that astronauts may experience when landing on or launching from the surface of the Moon. In Phase II, the tilt tests simulating the same gravity levels from Phase I will be repeated, but a custom-made lower-body compression garment will be worn to see if wearing the garment affects the development of orthostatic intolerance. For both study phases, before tilting, a drug will be administered to reduce the amount fluid in the blood (plasma) to levels similar to that experienced by astronauts during spaceflight.

NCT ID: NCT06467812 Recruiting - Healthy Clinical Trials

Fluid Loading Countermeasures

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The purpose of Fluid Loading Countermeasures is to determine how the volume of blood and of plasma (liquid part of blood) change during a normal day, how these are affected by drinking an additional amount of fluid either as water and salt tablets (as astronauts do) or an electrolyte beverage (similar to but tastes saltier than Gatorade®), and how altering the timing at which the additional fluid is consumed affects blood and plasma volume. This study observes how blood volume changes over ~9 hours of the day during 4 separate visits in healthy participants. During 1 visit participants will drink a small amount of water throughout the visit. During the other 3 study visits participants will drink the small amount of water plus either more water with salt tablets or an electrolyte solution. Consuming the additional fluids is called "fluid loading". This study is meant to simulate the food and fluid consumption of astronauts on landing day. The goal of this study is to determine the magnitude of plasma volume change that occurs with each condition of the protocol. (ICF 1.1, 3.1)

NCT ID: NCT06467604 Recruiting - Obesity Clinical Trials

CRAVE Study: Comparing Craving Responses and Diet Quality of GLP1 Receptor Agonist Users

Start date: June 12, 2024
Phase:
Study type: Observational

This study aims to assess the impact of GLP-1 receptor agonists, semaglutide and tirzepatide, on food cravings and diet quality in individuals with overweight or obesity. Over 24 weeks, up to 150 adult participants will be monitored using questionnaires and dietary records at 0, 12, and 24 weeks to measure changes in diet quality, disordered eating, food cravings, and hunger. This research, conducted with Seen Medical Group at Knownwell Health Clinic, seeks to fill the gap in literature on the dietary quality effects of GLP-1RAs.

NCT ID: NCT06467461 Recruiting - Parkinson Disease Clinical Trials

Identification of Prodromal Neurodegeneration in Serotonergic-Induced REM Sleep Behavior Disorder

Start date: February 8, 2024
Phase:
Study type: Observational

This project will test the hypotheses that people with 5-HT RBD have systemic alpha- synuclein pathology, prodromal DLB signs, and brainstem lesions in regions that control REM sleep. AIM 1 will seek to detect abnormally phosphorylated alpha- synuclein aggregates on targeted skin biopsy in a cohort of people with 5-HT RBD and matched controls (taking SSRIs but without RBD). Aim 2 will use ultra-high field MRI at 7T to examine the pontine region of the coeruleus/subcoeruleus complex for evidence of neurodegeneration as well as segment and parcellate REM sleep related neuronal structures. Aim 3 will test for speech deficits. While these aims are independent we suspect that the severity of autonomic, speech and cognitive deficits will correlate with loss of neuromelanin signal on MRI and pathology on skin biopsy. The investigation is a longitudinal designed study to examine histopathology, neuroimaging changes and speech function from baseline (Time 1) to a follow-up after 30 months (Time 2). A total of 60 individuals, 30 with 5-HT RBD and 30 controls, will be recruited at Time 1, brought back at Time 2, and tested across all Aims at both study visits.

NCT ID: NCT06467344 Recruiting - Stargardt Disease Clinical Trials

Study to Evaluate ACDN-01 in ABCA4-related Retinopathy (STELLAR)

STELLAR
Start date: June 29, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study is an open-label, single ascending dose clinical trial in participants who have ABCA4-related retinopathies. This is the first-in-human clinical trial in which ACDN-01 will be evaluated for safety, tolerability, and preliminary efficacy following a single subretinal injection of ACDN-01.

NCT ID: NCT06467136 Recruiting - Apraxia of Speech Clinical Trials

Motor Imagery for Treatment Enhancement and Efficacy in Persons With Apraxia of Speech

MI-TEE
Start date: December 11, 2023
Phase: N/A
Study type: Interventional

Treatment of post-stroke apraxia of speech (AOS) requires frequent and ongoing practice with a speech-language pathologist to facilitate lasting behavioral change, which is costly and, therefore, inaccessible to many patients. Thus, there is a critical need to identify novel, cost-effective ways to supplement speech therapy to increase opportunities for practice and optimize treatment outcomes. Our long-term goal is to develop an effective, home-practice, computer-based, motor imagery protocol Motor Imagery for Treatment Enhancement and Efficacy (MI-TEE) which will serve as an adjunct to routine speech therapy to optimize treatment response in persons with AOS. The overall objectives of this application are to (i) evaluate the acceptability and feasibility of MI-TEE as a home practice program and (ii) determine the efficacy of MI-TEE with speech therapy, compared to speech therapy alone, in improving speech production in people with AOS. Our central hypothesis is that MI-TEE will be an accessible, feasible, and efficacious adjunct to speech therapy. To attain our objectives, the following specific aims will be pursued using two single-subject experimental designs with multiple baselines across participants (n=18): 1) Evaluate the acceptability and feasibility of MI-TEE as an adjunct to speech therapy for the rehabilitation of AOS; and 2) Compare the efficacy of adjunctive MI-TEE plus standard speech therapy to standard speech therapy alone. Under the first aim, observational data, surveys, and semi-structured interviews will be employed to assess the acceptability (perceived satisfaction, appropriateness, and intent to continue use) and feasibility (recruitment, retention, and intervention adherence rates) of MI-TEE. For the second aim, accuracy of articulation for trained words and untrained words (generalization) will be measured pre-treatment, repeatedly during the treatment phase, and post-treatment. Improvements in speech accuracy will be documented using a binary scoring system (correct/incorrect). Multilevel analyses will be used to address rate of acquisition, overall change, and response variation across participants.

NCT ID: NCT06466876 Recruiting - Clinical trials for Autism Spectrum Disorder

Word Learning in Autistic Children

Start date: July 28, 2023
Phase: Early Phase 1
Study type: Interventional

Children on the autism spectrum sometimes have difficulty learning new words and using the newly taught information in different situations. In this study, we are testing whether strategies that have been found to improve word learning in non-autistic children will also help autistic children. Specifically, we aim to test whether autistic children learn words more successfully if we teach the words by repeating the words to the child (re-study) or if we teach the words by first labeling each word and then quizzing the child (repeated quizzing). The main questions it aims to answer are: - When teaching nouns (names of exotic animals), is learning stronger if autistic children re-study or engage in repeated quizzing of the newly taught words? - When teaching adjectives (visible features of objects, like a bumpy chair), is learning stronger if autistic children re-study or engage in repeated quizzing of the newly taught adjectives? - Does the word learning condition (re-study vs. repeated quizzing) impact whether autistic children are more successful in demonstrating their knowledge of the newly taught words in different contexts? - Are autistic features related to patterns of word learning? Participants will: - Learn new words with half of the words being taught in one way (re-study) and the other half of the words being taught in the other way (repeated quizzing). - Participate in 5-minute and 1-week tests of the newly taught words to measure child learning. - Complete other language, thinking, and autism clinical assessments.

NCT ID: NCT06466655 Recruiting - Middle-aged Adults Clinical Trials

Daily Stress and Vascular Function in Midlife as a Risk Factor for Cognitive Decline

Start date: May 30, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to better understand how day-to-day stress affects cardiovascular health and brain function in middle-aged adults. The main question is aims to answer is whether the link between daily stress and vascular dysfunction is a potential mechanism of increased risk for future cognitive decline. Participants will complete two 15-day "testing cycles" separated by ~6 months. During each cycle, participants will complete two daily assessments of stress and brain health using an online survey tool for 14-consecutive days. On the last day of each cycle, vascular function will be assessed during a laboratory visit.