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NCT ID: NCT05587530 Suspended - Suicide Clinical Trials

Zero Suicide Implementation in Outpatient Mental Health Clinics

Start date: November 20, 2022
Phase: N/A
Study type: Interventional

The aim of this study is to develop a manualized suicide prevention intervention to improve the retention and engagement of suicidal clients. (For the purposes of this proposal, engagement is defined as return to treatment after the initial session and retention as treatment attendance in an ongoing manner.) In the prior grant received by the investigators (#R01 MH112139) a large-scale project implementing evidence-based suicide prevention practices in 165 outpatient behavioral health clinics in New York State, it was determined that several aspects of the Zero Suicide model were successfully implemented but that treatment engagement and retention of acutely suicidal clients was far from optimal. This project will have two phases; only the second phase is considered a clinical trial. In the first phase, the investigators will conduct qualitative interviews with clients engaged in outpatient behavioral health for suicide-related reasons, as well as outpatient behavioral health staff (peer specialists and clinicians) with experience working with suicidal clients, to determine to determine client, clinician and situational facilitators and barriers of suicidal clients' engagement in ongoing care. Specifically, interviews will assess if the proposed interventions of shared decision-making (SDM), structured phone outreach (SPO) and peer support are acceptable and feasible from both a client and staff perspective and perceived to be effective in enhancing treatment engagement and retention and decreasing suicidal ideation and behavior. The investigators will also conduct secondary quantitative data analyses with administrative data obtained during the previously-funded project to examine characteristics of those who did not engage or remain in treatment and/or had self-harm behavior during the implementation period, to identify clients who may benefit from additional support or assistance at the outset of treatment and during ongoing care. In the second phase of the study, the investigators will use the findings from the first phase to develop a manualized treatment engagement and retention protocol and conduct a small pilot study to assess the protocol's feasibility and acceptability to clients and staff (peer specialists and clinicians) and preliminary effectiveness, as indicated by client satisfaction and engagement.

NCT ID: NCT05581095 Suspended - Pregnancy Clinical Trials

Empowering Mindfulness, Body Respect, and Compassionate Eating Among Women Who Binge Eat During Pregnancy

Start date: August 2023
Phase: N/A
Study type: Interventional

Primary Study Aims: 1. To evaluate the feasibility, acceptability, and preliminary efficacy of a 10-week mindful eating self-help program for women who binge eat during pregnancy. Primary efficacy targets will include measures of mindful eating and binge eating. Secondary efficacy targets will involve measures of body image and well-being. 2. To evaluate the incremental utility of adding use of a companion mindful eating smart phone application for enhancing the acceptability and preliminary efficacy of the program. 3. To gain insights into ways in which this program may be better tailored to the experiences of pregnancy for future program adaptation and refinement.

NCT ID: NCT05563948 Suspended - Cannabis Clinical Trials

Repeated Administration of Cannabis Varying in THC and CBD

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

The majority of the >3 million medical cannabis patients in the U.S. use cannabis products to manage pain but many questions remain. This project is designed to answer three questions that will fill important voids in the field's understanding of sustained cannabis use: 1) is abrupt cessation of cannabis associated with increased pain sensitivity; 2) does tolerance develop to the analgesic and abuse-related effects of repeatedly administered cannabis with varying ratios of THC and CBD, and is this tolerance reversible following a period of abstinence; 3) how does repeated cannabis use affect levels of endocannabinoids, and are these changes associated with changes in pain sensitivity and abuse liability? In this study, the investigators will enroll participants (N=100 healthy, cannabis-using men and non-pregnant women, ages 21-65) inpatient for 15 days. They will be randomized to one of four cannabis conditions (n=25/group). Following a day of standardization on which participants will receive their assigned cannabis condition (Day 1), cannabis will be administered repeatedly for 14 days (Day 2-15). The investigators will measure abuse-related effects ("Good Drug Effect"), endocannabinoid levels and two distinct types of experimental pain: The Cold Pressor Test and Quantitative Sensory Testing Thermal Temporal Summation. Given the widespread use of cannabis for pain, understanding the consequences of daily repeated administration of cannabis with THC:CBD ratios that are representative of most medical cannabis products on pain, abuse liability, and endocannabinoids is imperative.

NCT ID: NCT05554341 Suspended - Clinical trials for Metastatic Malignant Solid Neoplasm

Testing the Use of Nilotinib and Paclitaxel as a Treatment for Patients With Prior Taxane Treatment, A ComboMATCH Treatment Trial

Start date: July 14, 2023
Phase: Phase 2
Study type: Interventional

This phase II ComboMATCH treatment trial evaluates nilotinib with paclitaxel for the treatment of patients with solid cancers that are growing, spreading, or getting worse (progressive) and that have previously been treated with taxane therapies. Nilotinib is in a class of medications called kinase inhibitors. It works by binding to and blocking the action of a protein called ABL, which signals tumor cells to multiply. This helps slow or stop the proliferation of tumor cells. Paclitaxel is a drug that blocks cell growth by stopping cell division and it may kill tumor cells. Giving nilotinib with paclitaxel may be effective at treating patients with progressive solid cancers that have previously been treated with taxane therapies.

NCT ID: NCT05554159 Suspended - Brain Tumor Clinical Trials

A Virtually Delivered Exercise Intervention To Mitigate Cognitive Deficits From Radiotherapy In AYAs With Brain Tumors

Start date: June 5, 2023
Phase: N/A
Study type: Interventional

To test a new investigational virtual exercise program for adolescents and young adults (AYAs) with brain tumors who plan to receive cranial radiotherapy

NCT ID: NCT05552157 Suspended - Dementia Clinical Trials

A Study of Potential Disease Modifying Treatments in Individuals at Risk for or With a Type of Early Onset AD Caused by a Genetic Mutation

DIAN-TU
Start date: December 2, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose is to evaluate the biomarker effect, safety, and tolerability of investigational study drugs in participants who are known to have an Alzheimer's disease (AD)-causing mutation. Part 1 will determine if treatment with the study drug prevents or slows the rate of amyloid beta (Aβ) pathological disease accumulation demonstrated by Aβ positron emission tomography (PET) imaging. Part 2 will evaluate the effect of early Aβ plaque reduction/prevention on disease progression by assessing downstream non-Aβ biomarkers of AD (e.g., CSF total tau, p-tau, NfL) compared to an external control group from the DIAN-OBS natural history study and the DIAN-TU-001 placebo-treated participants.

NCT ID: NCT05542238 Suspended - Clinical trials for Spinal Cord Injuries

The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury

Start date: September 6, 2022
Phase: N/A
Study type: Interventional

The aims of this proposal are to: 1) investigate whether individuals with spinal cord injury (SCI) demonstrate cardiac autonomic, cerebrovascular, and cognitive dysfunctions compared to non-injured age- and sex-matched controls in the following conditions: supine rest and head-up tilt/face-cooling test; 2) examine if autonomic completeness/ incompleteness, physical activity, and psychological distress are predictors for dysfunctions during supine rest and head-up tilt/face cooling conditions in SCI individuals; 3) examine if one bout of moderate-intensity aerobic exercise temporarily improves cardiac autonomic and cerebrovascular functions and thereby improves cognition when in supine rest and head- up tilt/face cooling conditions. The study will include an initial visit and an experimental visit to our lab. Three groups of participants will be included in this study: Group 1, SCI with acute exercise; group 2, SCI with rest-control; and group 3, age- and sex-matched non-injured individuals. Cardiovascular variables, such as heart rate variability, blood pressure variability, and cerebrovascular variables, such as cerebral blood flow velocity and oxygenated hemoglobin, and cognitive performance will be examined. The investigator hypothesizes that individuals with SCI will have impaired cardiac autonomic, cerebrovascular, and cognitive functions compared to the non-injured controls, and an acute exercise can improve those functions. Autonomic completeness/incompleteness, physical activity, and psychological distress are significant factors that predict cardiac autonomic, cerebrovascular, and cognitive functions in individuals with SCI.

NCT ID: NCT05529316 Suspended - Advanced Melanoma Clinical Trials

A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma

Start date: December 12, 2022
Phase: Phase 2
Study type: Interventional

This study is an open-label, 2-part, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab in participants with advanced cutaneous melanoma refractory to checkpoint inhibitor therapy.

NCT ID: NCT05519930 Suspended - Pancreatic Cancer Clinical Trials

Pancreatic Cancer Early Detection Registry

Start date: October 18, 2016
Phase:
Study type: Observational [Patient Registry]

Identify individuals who are at moderate and high risk or predisposed to developing pancreatic cancer with a familial history in which data collected from this study will be used to identify clinical factors associated with early detection of pancreatic cancer.

NCT ID: NCT05515692 Suspended - Clinical trials for Malignant Solid Neoplasm

Electron Beam Radiotherapy for the Treatment of Refractory Sclerodermatous Chronic Graft Versus Host Disease

Start date: June 30, 2024
Phase: Early Phase 1
Study type: Interventional

This clinical trial tests the safety and side effects of a single small dose (fraction) of electron beam radiotherapy (e-BRT) at 10 Gy dose in treating patients with refractory (did not respond to other treatments) sclerodermatous chronic graft versus host disease (GVHD). GVHD is the most common complication after bone marrow transplant from a donor and happens as a result of donor immune cells attacking patients cells. Fibroblasts are skin cells that produce collagen and fibers and are the cells mainly involved in development of skin GVHD. Previous research has shown that fibroblasts can become fibrocytes (inactive fibroblast) at the fastest rate after receiving 8 Gy or more radiation. Moreover, regulatory T cells (Tregs) are cells from the immune system that can control GVHD and previous research has shown that radiation can increase the number of Tregs. Therefore, e-BRT at 10 Gy has the potential to improve GVHD by increasing the fibroblast to fibrocyte speed and the number of Tregs.