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Found 7 Actively Recruiting clinical trials
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Researchers are collecting Optical Coherence Tomography OCT data to study both normal and diseased eyes, including conditions such as retinal disease, glaucoma, and corneal disease. This observational study aims to gather detailed imaging information to better understand these eye conditions using the A10900 OCT device. Participants will undergo OCT imaging with the A10900 device, which captures detailed pictures of the eyes structures. The study includes groups with retinal disease, glaucoma, corneal disease, and healthy eyes. Each participant will have OCT scans taken to collect data relevant to their specific eye condition or normal eye status. During the study, participants will have their eyes scanned with OCT and may undergo vision tests like best-corrected visual acuity BCVA. Researchers will count the number of OCT scans performed over one year to measure outcomes. Participants will be monitored for their ability to tolerate imaging and comply with study procedures. The study includes healthy volunteers and people with various eye diseases, with ongoing safety and imaging quality assessments.
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Excessive anxiety is common among elementary school children and can seriously affect their academic, social, and behavioral functioning. This research aims to evaluate the effectiveness of a brief, school nurse-delivered program called Child Anxiety Learning Modules CALM compared to a relaxation-only program CALM-R and a waitlist control. The study also looks at the cost effectiveness of CALM and explores factors that might influence its impact on childrens anxiety and school outcomes. The study involves three groups children receiving the full CALM program, children receiving the CALM-R relaxation modules, and a waitlist group that waits eight weeks before starting treatment. Both CALM and CALM-R include five modules delivered over eight weeks by trained school nurses. The CALM program includes psychoeducation, relaxation training, exposure therapy, cognitive restructuring, and relapse prevention, while CALM-R focuses on relaxation skills like deep breathing and muscle relaxation. Participants will be assessed before treatment, after eight weeks, and again at a 12-month follow-up. Researchers will use various measures including anxiety symptom ratings, behavioral avoidance, school attendance, academic performance, and teacher and parent questionnaires to evaluate outcomes. The study also monitors safety and treatment adherence. The total participation involves these assessments and the intervention period, with long-term follow-up to understand lasting effects.
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This research aims to evaluate the effectiveness of Fathers for Change F4C, a father-focused intervention, compared to a standard Batterer Intervention Program BIP in reducing family violence and child mental health issues. The study focuses on fathers with a history of Intimate Partner Violence IPV and examines how fathers emotion regulation and reflective functioning may influence outcomes for both the family and children. It addresses the gap in current interventions by specifically involving fathers and targeting the roots of offending behaviors. Participants are randomly assigned to one of two groups Fathers for Change or the Duluth Model BIP. Fathers for Change involves 18 weekly individual sessions of 60 minutes each, focusing on emotion regulation, reflective functioning, and improving family communication. The Duluth BIP also consists of 18 weekly individual sessions of 60 minutes, focusing on psychoeducation about the impact of violence, power and control tactics, and anger management skills through didactics and role plays. Throughout the study, participants and their families undergo assessments at baseline, 19 weeks, 43 weeks, and 70 weeks to measure changes in physical and verbal IPV, child maltreatment, and child mental health symptoms such as posttraumatic stress, anxiety, depression, and aggression. Father-child interactions and coercive controlling IPV are also evaluated. Data collection includes observational coding during sessions and weekly self-ratings. The study aims to understand the mechanisms of change and improve interventions for families affected by IPV and child maltreatment.
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Healthy Volunteer
This research aims to improve how pediatric primary care providers PCPs help children and teens with anxiety. Anxiety disorders are the most common psychiatric illnesses in youth, often causing serious disability and predicting future mental health problems. However, many anxious children do not receive mental health services, especially in areas with few specialists. The study tests the Anxiety Action Plan AxAP, a brief intervention designed to be delivered by PCPs during community clinic visits to better identify and support anxious youth. The trial compares two approaches the Anxiety Action Plan MAPP, which includes about 4 sessions of a behavioral intervention based on exposure therapy strategies delivered by the PCP, and Enhanced Usual Care EUC, which provides families with videos, books, and other anxiety-reduction resources. PCPs in the MAPP group receive training, coaching sessions, and complete study questionnaires. Families assigned to MAPP receive the intervention from their PCP, while those in EUC receive educational materials. Participants will complete assessments including the Clinical Global Impression Improvement scale at 2 months post-intervention and again at 6 months. PCPs also complete outcome measures 2 months after their first enrolled family. The study involves questionnaires, evaluations, and follow-up visits to monitor anxiety symptoms and treatment effects. The total participation time varies but includes assessments at key intervals to measure improvements and feasibility of the new intervention.
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Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication LSS with NC in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression IPD. The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the studys NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.
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Healthy Volunteer
High blood pressure, also known as hypertension, is a common condition affecting the arteries and increasing the risk of serious health problems like heart attack and stroke. Researchers are studying the effects of short periods of exercise on blood pressure in adults with hypertension or pre-hypertension. This study aims to evaluate both immediate and long-term impacts of brief exercise sessions on blood pressure and related vascular health. Participants will first complete a single resistance exercise session using a leg press, with or without a blood flow restriction technique, to monitor immediate blood pressure changes. Then, over six to eight weeks, participants will engage in a home-based program involving two types of wall-sit exercises clustered wall-sits done continuously and scattered wall-sits performed at four different times throughout the day. A control group will not receive any exercise intervention. During the study, participants blood pressure will be monitored over 24 hours from enrollment to the end of six weeks. Researchers will assess vascular health measures like endothelial function and arterial stiffness at the start and after six weeks. The study uses random assignment to groups and double-blinding to compare exercise effects. Participants will be involved in exercise sessions, home monitoring, and regular assessments throughout the study period.
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Chronic low back pain is a common and persistent health issue that often leads to increased pain sensitivity both at and away from the original pain site. This heightened pain response is linked to central sensitization, which can worsen with longer pain duration and intensity. The study explores how treatments that reduce this central excitability and boost pain inhibition might help, focusing on transcutaneous electrical nerve stimulation TENS as a non-drug, affordable, and simple option. The trial uses a randomized crossover design where participants receive three different treatments in random order active TENS at a high intensity, placebo TENS with a brief stimulation then off, and a no-treatment control with the device turned off to keep assessors unaware. The active TENS aims to activate the bodys pain-blocking pathways and reduce central excitability, potentially improving the ability to exercise and function. Participants undergo assessments measuring pain intensity at rest and during movement, pain sensitivity thresholds, and physical function tests such as sit-to-stand and repeated trunk flexion. These evaluations occur over a 3-week period, focusing on how TENS influences pain relief and physical ability. The study also monitors central pain modulation to understand TENS effects on pain processing.