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Fractures, Stress clinical trials

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NCT ID: NCT06358807 Recruiting - Clinical trials for Osteochondral Lesion of Talus

Microfracture With Platelet Rich Plasma Gel Injection for Ostechondral Lesion of the Talus

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

The goal of this clinical trial is to learn if combined local injection of platelet rich plasma (PRP) gel adds clinical efficacy to isolated arthroscopic microfracture in treatment of osteochondral lesion of the talus (OLT). The interface integration of the injured area will also be assessed via radiographic follow-up. The main questions it aims to answer are: - Does arthroscopic microfracture combined with PRP gel injection improve ankle function of participants based on American Orthopedic Foot and Ankle Society (AOFAS) Score? - Does arthroscopic microfracture combined with PRP gel injection improve interface integration of the injured cartilage on magnetic resonance imaging (MRI)? Researchers will compare arthroscopic microfracture with concomitant local injection of PRP gel to isolated microfracture to see if intraoperative PRP gel injection adds clinical efficacy to isolated arthroscopic microfracture in treatment of OLT. Participants will: - Undergo either isolated arthroscopic microfracture or microfracture with intraoperative injection of PRP gel - Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment - Take MRI preoperatively and 6, 12 and 24 months after surgery

NCT ID: NCT06353243 Recruiting - Preterm Birth Clinical Trials

Bilateral Infant Stimulation Study

BLISS
Start date: February 26, 2024
Phase: N/A
Study type: Interventional

This study will investigate stress that parents of children admitted to the neonatal intensive care unit (NICU) experience. Investigation of a novel intervention of using bilateral alternating stimulation to reduce parental stress and anxiety and increase bonding/attachment in NICU. Evaluate parental stress and feelings of bonding using surveys before and after the intervention. Intervention will be done at neonate's bedside while admitted to the NICU. Vital sign data will be collected as a marker of parent and neonate's stress response during the intervention.

NCT ID: NCT06278077 Recruiting - Insomnia Clinical Trials

Neurexan - a Clinical Trial in Short-Term Insomnia Patients

Start date: September 4, 2023
Phase: Phase 2
Study type: Interventional

This clinical study aims to understand the effects of a medication called Neurexan on sleep patterns and stress in people with short-term insomnia. The study involves comparing Neurexan to a placebo - a tablet that looks like Neurexan but lacks active ingredients. The main goal of the study is to determine if Neurexan can enhance sleep efficiency in those with short-term insomnia. Sleep efficiency, which is the proportion of time spent asleep in relation to total time in bed, including attempts to fall asleep, will be assessed through Polysomnography (PSG). PSG examines various sleep characteristics such as brain activity, muscle and heart activity, and breathing. Participants will take either Neurexan or the placebo for 14 days. Sleep efficiency will be evaluated using PSG before and after the treatment period. Additionally, sleep quality-related factors will be investigated using PSG data, sleep diaries, and participant-completed questionnaires. The study will also investigate Neurexan's impact on stress levels. This will be assessed using the Cold Pressor Test, which measures stress through having the participant immerse their hand into ice water, and measuring changes in blood pressure and heart rate, both indicators of stress. In addition, blood and saliva samples collected before and after treatment with Neurexan or placebo, will be analyzed for stress-related hormones such as cortisol. Patient questionnaires and Electroencephalography (EEG), a non-invasive brain activity recording, will further assess stress symptoms. Researchers will analyze data related to sleep efficiency, sleep quality, and stress symptoms. By comparing outcomes before and after Neurexan or placebo treatment, the study aims to detect improvements in these areas. Positive results with Neurexan but not with the placebo would provide robust evidence for Neurexan's efficacy in addressing sleep and stress management issues. This study contributes valuable insights into Neurexan's potential benefits for individuals with short-term insomnia.

NCT ID: NCT06269614 Recruiting - Clinical trials for Autism Spectrum Disorder

Assessing the Gut Microbiome and Its Association With Pediatric Stress and Cognition

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

Using a metabolomics approach in combination with eye-tracking data, this research study proposes to gather evidence from two interrelated body systems (gut and brain) in order to assess how the microbiome is involved in stress modulated symptoms in children with autism and children exposed to repeated stress in comparison to a control group.

NCT ID: NCT06256952 Not yet recruiting - Clinical trials for Alcohol Use Disorder

Effect of Social Isolation on the Role of Pavlovian Mechanisms for Control Over Alcohol Use

ReCoDe
Start date: February 19, 2024
Phase: N/A
Study type: Interventional

During the first funding period (1st FP) we investigated the impact of acute and chronic stress (Trier Social Stress Test, TSST) on Pavlovian-to-instrumental transfer (PIT). Moreover, we developed a novel full transfer task that allows assessing both general and specific PIT to investigate whether specific PIT differs between alcohol use disorder (AUD) and control subjects. We found that our online version of TSST induced stress and thereby amplified PIT effects in participants. Preliminary analyses of the full transfer task indicate that AUD participants exhibit a stronger specific PIT effect compared to controls. Based on these findings, we want to assess the following aim for this study: Investigate the effect of experimentally induced social exclusion on alcohol-specific and general PIT effects in AUD and control participants.

NCT ID: NCT06142305 Completed - DDH Clinical Trials

Supracondylar Femur Fracture After DDH

Start date: January 1, 2017
Phase: N/A
Study type: Interventional

incidence of ipsilateral Supracondylar femoral fractures after cast removal for Developmental dysplasia of the hip (DDH) surgery

NCT ID: NCT06139705 Recruiting - Clinical trials for Coronary Artery Disease

Weather Sensitivity and the Effects of Walking in Nature on Stress Response of Individuals With Coronary Artery Disease

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

The goal of this clinical trial is to investigate how walking in different environments affects the psychophysiological responses to the stress of individuals with coronary artery disease (CAD) according to their weather sensitivity. Awareness about the potential influence of weather sensitivity on the psychophysiological reactions to stress in patients with CAD disease may contribute to the planning and implementation of actions leading to improved medical care services and preventative measures that help to avoid the worsening of health and well-being in the future.

NCT ID: NCT06138548 Not yet recruiting - Clinical trials for Subchondral Insufficiency Fracture

Bio-Integrative, Fiber-Reinforced Kneebar for Treating Subchondral Insufficiency of the Knee

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

The OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts in the presence of appropriate additional immobilization (e.g., rigid fixation implants, cast, brace). Our hypothesis is that the use of OSSIOfiber® Trimmable Fixation Nails for treating subchondral insufficiency of the knee will result in improvement of patient-reported outcomes and imaging findings. The primary objective of this study is to evaluate the effectiveness of implanting bio-integrative OSSIOfiber® Trimmable Fixation Nails, organized in a bi-cortical rafter formation within the tibia or femur for the management of subchondral insufficiency. This use is not considered off-label because we are using the TFNs in the way they are intended to be used via FDA approval.

NCT ID: NCT06105853 Recruiting - Clinical trials for Alcohol Use Disorder

Neurobehavioral Profiles of Adaptive Stress Responses in Individuals With Alcohol Use Disorder

A03
Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The goal of this observational study is to investigate longitudinal stress response profiles and adaptive versus non-adaptive stress responses in alcohol use disorder. The main questions the projects aims to answer are: What are the neurobehavioral underpinnings of adaptive stress responses and resilience to repeated stress exposure with regards to: - alcohol craving? - alcohol use? - their modulation by prior stress exposure, social interactions, coping strategies and individual health behavior? Participants will: - be exposed to an established experimental stress-induction protocol, the Trier Social Stress Test - be exposed to their favorite drink in a bar lab environment - be assessed using fMRI to determine their neural alcohol cue reactivity, response inhibition, and emotion processing - conduct an ambulatory phase to assess stressors, alcohol craving, substance use and details on social interactions, health behavior and coping strategies using ecological momentary assessment tools.

NCT ID: NCT06063174 Enrolling by invitation - Stress Clinical Trials

Stress & Resilience Study

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

Goal 1: The investigators will quantify lifetime stress burden and examine mechanisms linking Adverse Childhood Experiences (ACEs) and health. The investigators will quantify the early life and total lifetime stress burden of a representative sample of about 725 adults (aged 18+) across northern and southern California. In addition, the investigators will examine how prior life stress exposure and current stress levels are associated with differences in psychosocial, immune, metabolic, physiologic, and clinical outcomes for all participants at baseline. Goal 2: The investigators will develop and test a biopsychosocial intervention using existing programs, platforms, resources, and core components from trauma and resilience research that will target five stress-related domains (i.e., cognitive response style, social relationships, eating, sleep, and physical activity) using cognitive restructuring and mindfulness, interpersonal skills training, mindful eating training, sleep training, and behavioral activation/mobility training. The investigators will then assess the efficacy and acceptability of the intervention in about 425 high stress exposure participants from Goal 1. Following their baseline assessment, about 425 participants will be randomly assigned to receive for 12 weeks (a) personalized intervention, (b) environmental education (active control) or (c) nothing (non-active control). The investigators will also assess the efficacy of the personalized intervention by comparing changes in outcomes by condition from baseline (prior to randomization) to immediately after the intervention, and then again after 12 weeks following intervention completion. The interventions will be entirely online/remote.