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NCT ID: NCT06049420 Not yet recruiting - Obesity Clinical Trials

Lifestyle Medicine: Establishing Clinical Approaches to Chronic Disease for Rural Patients

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

Developed nations worldwide are currently enduring a health crisis, as chronic diseases continue to decrease quality of life and promote additional disease states or even death for much of the population. Rural populations are at a particular disadvantage, as they lack access to health clubs, wellness programs and similar resources that are more available in urban areas. Although pharmaceutical therapies have continued to show therapeutic advancements, the rates of disease onset and death from chronic disease has not seen similar improvements, and in fact continue to worsen. Excitingly, significant evidence has been published demonstrating an affordable, effective treatment to directly treat and prevent these chronic diseases, but few have demonstrated successful implementation of this therapy, which is improved lifestyle. Specifically, physical activity and healthy body composition are powerful therapeutics that have been demonstrated to effectively combat and prevent chronic diseases. Additionally, improving these lifestyle factors are often more effective than pharmaceutical interventions without the wide range of side effects. Unfortunately, barriers exist on multiple tiers in the practice of family medicine that demote the implementation of lifestyle medicine. To better serve patients at risk of, or suffering from chronic disease, the investigators are seeking to establish a lifestyle medicine prescription program for rural West Virginia. This program will provide patient education on the benefits of physical activity, body composition, and help patients identify strategies to implement healthy lifestyle choices that can be sustainable for the long-term. Patients will be advised on local opportunities to increase physical activity (yoga studio, martial arts, fitness facilities, aquatic center, etc.) and provided access to the facilities they are most likely to adhere to regularly. They will also be provided training on exercise techniques, equipment, and facilities to increase familiarity and comfort in these settings.

NCT ID: NCT06048263 Not yet recruiting - Clinical trials for Postpartum Depression

The Perinatal Synergistic Multi-component Intervention to alLeviate dEpressive Symptoms. A Case Series

SMILES
Start date: May 1, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this open label case series is to learn about the feasibility of conducting a future randomised controlled trial to evaluate how well the Perinatal SMILES intervention works in improving post-cesarean mood in low-income women. The main questions it aims to answer are: 1. Is it feasible to recruit a sufficient number of participants? 2. Is it feasible to administer Perinatal SMILES and 3. Is it feasible to collect participant outcomes? To profile EEG in participants at rest and in response to TMS, before and after subcutaneous ketamine Participants will: 1. Complete five sessions of interpersonal therapy 2. Receive two skin injections of ketamine, approximately 24 hours apart, in the first four postpartum day 3. Receive additional therapy sessions before (to prepare for ketamine) and after (interpersonal therapy) each ketamine injection 4. Undergo assessments of brain electrical activity (at rest and evoked by trans-cranial magnetic stimulation) before and at three timepoints in the 10 hours after each ketamine injection 5. Complete mood assessments over the first 12 postpartum weeks

NCT ID: NCT06047977 Not yet recruiting - Lymphocytes Clinical Trials

Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors

Start date: October 1, 2024
Phase: Phase 1
Study type: Interventional

Part One of this study will determine the feasibility of creating Tumor-Infiltrating Lymphocyte (TIL) product prospectively from high-risk pediatric solid tumors. Part Two of this study will determine the safety of TIL therapy with lymphodepleting chemotherapy and post-TIL Interleukin-2 in high-risk pediatric solid tumors

NCT ID: NCT06047886 Not yet recruiting - Clinical trials for Myelodysplastic Syndromes

CD34 Selection Using the Automated CliniMACS Prodigy

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

Patients with graft failure or delayed engraftment may benefit from a hematopoietic stem cell boost or an additional hematopoietic stem cell transplantation procedure. In such settings standard immune suppression strategies are avoided due to their myelosuppressive nature. Therefore those patients are at increased risk of graft versus host disease, and the infusion of a CD34 selected graft would reduce such a risk. The infusion of CD34 selected graft using CliniMACS plus is currently FDA FDA-approved indication for acute myeloid leukemia. However, the use of the Prodigy would streamline the processing, in terms of hands-off procedure, allowing to provision of this product to the patients without strains on the cell therapy lab team. This procedure has been demonstrated safe and effective in several single-center studies and is currently in advanced phase investigation in several studies for malignant and non-malignant conditions.

NCT ID: NCT06046014 Not yet recruiting - Body Image Clinical Trials

Feasibility of Expressive Writing for Body Image Distress and Anxiety Among Adolescent and Young Adult Cancer Survivors

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

Each year, about 89,500 adolescents and young adults (AYAs; 15-39 years old) are diagnosed with cancer and up to 60% experience body image (BI) distress. BI is largely developed in adolescence and young adulthood and has implications for self-identity and quality of life. Cancer itself and its associated treatments precipitate changes to appearance as well as body sensation and function, all of which can alter BI and lead to increased anxiety. An in-home BI-focused expressive writing (EW) program offers a promising outlet for addressing BI distress and anxiety in a way that eliminates constraints of clinical time and specialist availability. There are no recommended interventions to help AYA cancer survivors cope with BI distress. To address this knowledge gap, the objective of this this pilot randomized-controlled trial is to determine the feasibility of a four-week BI-focused EW intervention to decrease BI distress and anxiety among AYA cancer survivors with the hypothesis that this intervention will reduce BI distress and anxiety.

NCT ID: NCT06045988 Not yet recruiting - Alzheimer Disease Clinical Trials

Automated, Assistive, Non-Contact Sleep Quality Monitor for Individuals With Alzheimer's Disease

Start date: February 1, 2025
Phase: Phase 2
Study type: Interventional

This study seeks to evaluate the utility and efficacy of the Non-Contact Sleep Quality Monitor System when used to monitor the sleep quality of individuals living in long-term care (LTC) with either Alzheimer's Disease (AD) or Alzheimer's Disease Related Dementia (ADRD). This before-after comparison trial will be conducted in several LTC facilities to evaluate the effect access to System Sleep Quality Data has on documentation of sleep disorders or treatments and sleep quality change over time for AD/ADRD participants in the intervention group as compared to the control group. All subjects will undergo sleep quality monitoring for 4-weeks. At the end of the first 2-weeks, research staff and LTC facility staff and medical providers will receive access to sleep monitoring data. We hypothesize that when real-time System Sleep Data is shared with LTC staff or healthcare providers, that sleep disturbances will be more readily detected, leading to timelier, better tailored treatment interventions for sleep disturbances, thereby improving sleep quality and decreasing daytime physical inactivity.

NCT ID: NCT06045936 Not yet recruiting - Limb Pain, Phantom Clinical Trials

A Study of Contralateral Limb Block

Start date: May 2024
Phase: Phase 4
Study type: Interventional

This research is being done to determine if an anesthetic like Lidocaine, may be effective when injected around the sciatic nerve of the intact limb in patients with limb loss pain on the contralateral side.

NCT ID: NCT06045650 Not yet recruiting - Clinical trials for Borderline Personality Disorder

Relationship Between Oxytocin Level, Trust, and Attachment in Individuals With Borderline Personality Disorder

Start date: June 1, 2024
Phase:
Study type: Observational

We aim to assess the baseline oxytocin levels in individuals with borderline personality disorder and correlate those levels with social behavior, and compare the results with controls. Primary Hypothesis (H1): There is a significant difference in trust-related behavior as measured by oxytocin (OXT) levels between borderline personality disorder (BPD) patients and healthy controls. Secondary Hypotheses: H2: The trust-related behavior in BPD patients is significantly influenced by their level of emotional sensitivity. Specifically, higher emotional sensitivity in BPD patients is associated with lower trust-related behavior and vice-versa. H3: There is a significant correlation between trust-related behavior and childhood trauma in BPD patients. BPD patients with higher levels of reported childhood trauma will exhibit lower trust-related behavior compared to those with lower levels of trauma. H4: Trust-related behavior in BPD patients varies depending on their attachment styles. Specifically, BPD patients with insecure attachment styles will exhibit lower trust-related behavior compared to those with secure attachment styles. H5: There is a significant correlation between trust-related behavior and BPD severity. Patients with more severe BPD symptoms will exhibit lower trust-related behavior compared to those with less severe symptoms. H6: The levels of OXT in BPD patients will significantly correlate with their reported levels of emotional sensitivity, childhood trauma, attachment styles, and BPD severity. These hypotheses aim to address the complexities surrounding the modulation of trust-related behavior by oxytocin in BPD patients, taking into account various factors like emotional sensitivity, childhood adversity, attachment styles, and BPD severity. By testing these hypotheses, the study aims to provide a comprehensive understanding of the interplay between these factors in influencing trust-related behavior in BPD patients.

NCT ID: NCT06045390 Not yet recruiting - Glaucoma Clinical Trials

An App-based Instructional Platform to Improve Eye Drop Recall

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

The goal of this interventional study is to assess whether an in-office, language-concordant instructional app improves drop regimen recall in a population of glaucoma patients who are on multi-drop regimens. Participants will be divided into two groups -- those who use the app and those who do not. The app will have narrated information regarding the drop regimen, a quiz to test understanding of the regimen, and will enable a graphical printout of the eye drops and schedule. At one month, both groups will be assessed on their eye drop regimen recall.

NCT ID: NCT06043791 Not yet recruiting - Clinical trials for Labral Tear, Glenoid

Applicability of 3T Shoulder MRI in Detection of Labral Pathology

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

The purpose of this observational study is to compare image quality between 3 Tesla magnet (3T) non-contrast MRI to the current standard of MR arthrogram (1.5T magnet) in detecting shoulder labral and cartilage pathology. An orthopedic surgeon on the research team will screen for patients with high probability of labral and/or cartilaginous pathology and the need for advanced imaging. The orthopedic surgeon's inclusion of patients will be based on a thorough clinical exam and obtained history. Patients included in the study will be imaged using both protocols - the current standard of MR arthrogram with a 1.5T magnet and non-contrast imaging with a 3T magnet. Both sets of images will be interpreted by multiple fellowship-trained musculoskeletal radiologists for adequate intra and inter-rater reliability.