Treatment Trials

180,638 Clinical Trials for Various Conditions

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Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques
Description

This study has been initiated to evaluate the question, "What is the best way to protect the palate after a gum graft is removed?" The overall objective is to determine if there is a difference in PROMs of donor site healing using different palatal post-operative protection techniques.

Conditions

Mucosal Erosion, Gingival Recession

Evaluation of a Device to Reduce Motion Sickness and Spatial Disorientation
Description

The purpose of this research study is to learn how a wearable nerve stimulation device, the Spark Biomedical's Sparrow Ascent System™, impacts the development of spatial disorientation and/or motion sickness in a healthy population. Spatial disorientation is when there is a "mismatch" between where a person is, and where the sense organs in their body tell them where they are. These sense organs include the inner ear (the vestibular system), the eyes (the visual system), the sense of where one's legs, back, and neck are (proprioceptive system), and one's higher thinking (cognitive centers). If spatial disorientation is severe or occurs in motion-naïve individuals, spatial disorientation can lead to motion sickness. The Sparrow Ascent System™ is a wearable, battery-operated transcutaneous auricular (ear) neurostimulation (tAN) device. This means that it uses electrical pulses to stimulate branches of nerves on and/or around the ear, specifically the "vagus" and "trigeminal" nerves. These nerves are also responsible for your sensation of nausea and your heart rate (vagus nerve), as well as headaches (trigeminal nerve). The Sparrow System utilizes a flexible earpiece with embedded hydrogel electrodes that stick to the skin, the earpiece is disposable after use. This device is already Food and Drug Administration (FDA) approved for use in humans and is safely used for control of symptoms in a variety of other medical conditions, such as opioid withdrawal and acute stress reaction. In this study, we will determine if the Sparrow Ascent System™ impacts the development of spatial disorientation or motion sickness.

Conditions

Motion Sickness, Spatial Disorientation

Massage Impact on Sleep in Pediatric Oncology
Description

This study aims to determine the impact of massage therapy for pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT).

Conditions

Cancer, Pediatric Cancer, Chemotherapy Effect, Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Pediatric, Hematopoietic Stem Cell Transplantation (HSCT)

Evaluation of a Supervised Clinical Feeding Intervention
Description

Peanut allergies affect approximately 2.5% of children; are associated with significant mortality, morbidity, and economic costs; and often lead to persistent peanut allergies in adulthood. We now know however that early introduction of peanut products to infants prior to age 7 months and maintained in the diet regularly significantly reduces the rate of peanut allergies. Unfortunately, recent research shows that even when parents know the recommendations to feed peanut products early and often, \<50% of parents report introducing peanuts by age 9 months, \<45% are offering peanut products several times a week, and \<20% are offering the recommended 2 teaspoons at each feeding. Many parents cite a fear of reactions or a lack of knowledge on how to safely feed peanut products at this age. While there are recommendations to offer the first feeding in clinic this has not been widely implemented in general pediatrics clinics and we have no research to say this is an effective way to increase peanut consumption at home. This research is being conducted to assess the effectiveness of a supervised peanut feeding clinic in a pediatric office to increase rate of guideline recommended peanut consumption in infants by 9 months of age.

Conditions

Peanut Allergies in Children

Diffusion MRI for Quantitative Assessment of Myofascial Pain
Description

The purpose of this study is to assess the diagnostic accuracy of diffusion MRI for evaluation of the jaw muscles for patients with masticatory myofascial pain syndrome.

Conditions

Masticatory Myofascial Pain Syndrome

EEG-based Personalized Transcranial Magnetic Stimulation (eTMS) to Treat Post-Traumatic Stress Disorder
Description

This is a randomized, sham controlled study of the Electroencephalogram (EEG) based Transcranial Magnetic Stimulation (eTMS) treatment for Post-Traumatic Stress Disorder (PTSD). The recruitment goal is 110 participants who are United States Military veterans or first responders (e.g., firefighters, police, paramedics, etc.). The Study includes an EEG recording in order to determine the optimal treatment parameters for the eTMS system, followed by 15 in-office visits that take place over 21-28 total days. Two eTMS treatment sessions are administered during each office visit.

Conditions

Stress Disorder, Post Traumatic

Description of Patients With Type 1 Diabetes Treated With Teplizumab
Description

Type 1 diabetes mellitus (T1D) is a chronic autoimmune disease caused by the destruction of pancreatic β cells. T1D pathogenesis progresses through several stages: Stage 1 T1D includes the presence of β cell autoimmunity and thus presence of islet autoantibodies, without the presence of dysglycemia and symptoms. Stage 2 T1D includes the presence of islet autoantibodies and dysglycemia, also with no symptoms. Stage 3 T1D includes presence of islet autoantibodies, overt hyperglycemia, and symptoms; most patients with Stage 3 T1D meet standard diagnostic criteria for diabetes and require insulin treatment. Teplizumab has been shown to delay progression to Stage 3 in participants at Stage 2 in a Phase 2 clinical trial, leading to subsequent approval in the United States of America (USA). Patients outside of the USA are able to receive the treatment through Pre-Registration Import Licenses and Managed Access Programs. The current study will collect data on the use of teplizumab in routine care, to better understand which patients received teplizumab and how these patients were managed after they received the treatment.

Conditions

Type 1 Diabetes

Effects of a Mobile App-Based Mindfulness Intervention in Persons with Spinal Cord Injury and Chronic Pain
Description

The purpose of this study is to evaluate the efficacy of a 6-week app-guided MM intervention compared to a 6-week app-guided health education AC condition on pain intensity, pain interference, depression, and anxiety.

Conditions

Spinal Cord Injuries

Self-Directed Positive Psychology Intervention for Newly Diagnosed Multiple Sclerosis
Description

The goal of this clinical trial is to learn whether positive psychology (PP) exercises such as writing a letter of gratitude or remembering a past success can help individuals with newly diagnosed multiple sclerosis (MS) to feel more hopeful, happy, and healthy. The main questions it aims to answer are: * Is a five-week self-directed PP training intervention feasible and acceptable to individuals with newly diagnosed MS? * Does the completion of a five-week self-directed PP training intervention improve positive affect, emotional function and health-related quality of life (HRQOL) in individuals with newly diagnosed MS? * Are improvements in positive affect, emotional function and HRQOL maintained after the completion of the intervention? Participants will be randomized to the intervention or waitlist control group. There will be an intervention phase (weeks 1-5) and an extension phase (weeks 6-10). All participants will complete questionnaires at enrollment, 5 weeks and 10 weeks. They will complete 5 weeks of self-directed PP training exercises, either during the intervention phase (intervention group) or extension phase (waitlist control group) of the study. Researchers will compare participants in the intervention and waitlist control groups at the end of the intervention phase to see if there are improvements in positive affect, emotional function and HRQOL. For subjects in the intervention group who demonstrate improvement, researchers will determine if the benefit is maintained by comparing positive affect, emotional function and HRQOL at the completion of the intervention and extension phases of the study.

Conditions

Multiple Sclerosis

Groceries for Residents of Southeastern USA to Stop Hypertension
Description

GoFreshSE is a randomized control trial, testing the effects of a home-delivered, dietitian-assisted, DASH-patterned grocery intervention on blood pressure in adults with high blood pressure in Florida, Georgia, and Tennessee.

Conditions

Hypertension, Elevated Blood Pressure, Cardiovascular Diseases, Dietary Intervention

The ILet Experience Study
Description

A one-year, prospective single-arm cohort study to collect safety and effectiveness data on the iLet Dosing Decision Software during real-world use in people 6 years of age or older with type 1 diabetes (T1D) with 12 months follow-up.

Conditions

Type 1 Diabetes

Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3
Description

The objective of this study is to assess the safety and efficacy of Apreo BREATHE system when used to support native airways and release trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal medical treatment. The Apreo BREATHE Airway Scaffold is a permanent implant designed to tent open native airways. The study will include up to 250 participants at up to 25 study centers located in the United States and Europe. Study subjects will be followed for 3 years. The main questions it aims to answer are: Is it safe? Does it work?

Conditions

COPD, Emphysema

Enhancing Reading Recovery in Aphasia with TDCS and Phonomotor Therapy
Description

This study is designed for individuals with aphasia, a language disorder that affects many stroke survivors, making it difficult to read, speak, and understand language. Up to 70% of people with aphasia struggle with reading, which impacts their ability to communicate, work, and engage in daily life. The study aims to test a new approach to reading rehabilitation by combining Phono-Motor Treatment (PMT), a language therapy adapted to improve reading, with transcranial direct current stimulation (tDCS), a safe and painless brain stimulation technique. tDCS delivers a mild electrical current to the brain, which may enhance learning. This study will assess whether adding tDCS to PMT improves reading therapy outcomes.

Conditions

Stroke, Aphasia

A Study of Enfortumab Vedotin in People With Adenoid Cystic Carcinoma
Description

The purpose of this study is to find out whether enfortumab vedotin is an effective and safe treatment for people with adenoid cystic carcinoma (ACC).

Conditions

Adenoid Cystic Carcinoma

Radicle Spark for Women™ 24: Assessing the Impact of Health and Wellness Products on Sexual Health and Related Health Outcomes
Description

A randomized, double-blind, placebo-controlled, direct-to-consumer study assessing the impact of health and wellness products on sexual health and related health outcomes.

Conditions

Sexual Satisfaction, Sexual Function

Circadian Rhythms in Human Adipose
Description

The goal of this study is to understand the underlying circadian rhythms in subcutaneous adipose tissue of humans with our without continuous feeding and how these are altered in people who have obesity.

Conditions

Obesity, Abdominal, Feeding Patterns

Pulse Field Ablation for Post-Infarction Ventricular Tachycardia
Description

ASCEND is a randomized controlled open-label pilot study evaluating the safety and effectiveness of pulsed field ablation (PFA) with the novel FARAPOINT catheter compared to the standard radiofrequency (RFA) ablation with FlexAbility SE or ThermoCool ST catheter for ablation of ventricular tachycardia (VT) in the patients with ischemic cardiomyopathy and implantable cardioverter-defibrillator (ICD). The study hypothesis is that the PFA ablation is more efficient compared to the RFA technique but retains a comparable safety profile.

Conditions

Ventricular Tachycardia, Ischemic Heart Disease, Sustained VT

Optimization of Chrononutrition to Reduce the Risk of Disease in Shift Workers
Description

In this randomized controlled trial, the investigators will assess the health impacts of optimizing the timing of dietary consumption in nurses and nursing assistants who work night shifts, have a habitual eating window of 14 hours or more, and elevated weight. Participants will be randomized to one of three groups: (1) dietary monitoring, (2) dietary monitoring plus 10-hour daytime time-restricted eating (TRE), or (3) TRE with a low-glycemic snack during night shifts. The study includes a 2-week screening/baseline health assessment, with follow-up health assessments at 3-, 6- (primary outcome), and 12 months.

Conditions

Night Shift Work, Time Restricted Eating, Overweight, Obesity

Study of Oral Fluid Testing Approach
Description

The purpose of this study is to identify and evaluate oral fluid testing as a biologic measure of cannabis use days that can be assessed remotely. The researchers will conduct this fully virtual study among a community sample of 200 individuals aged 18-30 years who have used cannabis at least 1 time per week on average in the past 30 days. Participants will complete oral fluid (saliva) tests, urine tests, and Timeline Follow-back interviews (self-report) that indicate their recent cannabis use (delta-9-THC). Participants will present for 3 virtual study visits and be asked to complete activities in between: Study Visit 1 (Day 0; informed consent, baseline survey, TLFB interview), Study Visit 2 (\~Day 3; TLFB interview, urine testing), 6 days of at-home videorecorded oral fluid testing, Study Visit 3 (\~Day 12; TLFB interview, urine test, oral fluid test, survey, interview).

Conditions

Cannabis Use, Cannabis Intoxication, Cannabis Use Disorder

A Study of Electrocardiogram and Focused Cardiac Ultrasound for Enhanced Cardiac Disease Screening
Description

The purpose of this study is to evaluate and compare the effectiveness of active screening for SHD in asymptomatic outpatients referred for an ECG, using a combination of AI-ECG and FOCUS. Invites will be sent and participants enrolled electronically.

Conditions

Cardiac Disease

Exploration of HRQOL and Urinary Outcomes Following Partial Cystectomy
Description

This study explores and compares health-related quality of life and urinary outcomes in postoperative partial cystectomy and matched radical cystectomy patients.

Conditions

Bladder Carcinoma

Mixed-Methods Evaluation of Short-, Medium-, and Long-Term Outcomes Following Hip Treatment
Description

This study, titled "Mixed-Methods Evaluation of Short-, Medium-, and Long-Term Outcomes Following Hip Treatment," aims to assess the long-term effectiveness of treatments for pediatric hip conditions, including hip dysplasia, Legg-Calve-Perthes disease, SCFE, and avascular necrosis.

Conditions

Hip Dysplasia, Legg-Calvâe-Perthes Disease, Avascular Necrosis of Hip

Ending the Epidemic Interventions in the Dental Setting - UH3
Description

The purpose of this study is to use information technology (IT) to support the efficient delivery of HIV prevention and care best practices in the dental care setting.

Conditions

HIV-1-infection

"F!reF!ghterF!t": a Randomized Controlled Trial of Lifestyle Coaching Interventions for Obese Firefighters
Description

Our goal is to explore the effectiveness of 9- month lifestyle medicine based coaching intervention (individual and group coaching) versus control (usual care/ written health instructions). The primary study outcomes will be mean changes in body composition metrics . Secondary outcomes will be the prevalence of metabolic abnormities, progression/regression of Metabolic Syndrome, push-up \& sit/stand capacity, self-reported physical activity, and quality of life/diet/sleep measures.

Conditions

Obesity and Obesity-related Medical Conditions

Citicoline Dose on Energy Drink Efficacy
Description

The purpose of this study is to determine how the doses of cognitive-enhancing ingredients such as citicoline and caffeine effect the efficacy of acute energy drink consumption for improving cognitive performance (primary outcome), gaming performance, mood, energy expenditure, and fat oxidation. This study will utilize an In vivo acute response, randomized, double-blind, placebo controlled, cross-over trial study design. Participants will complete consent, complete screening, and then undergo familiarization and complete four experimental study visits. In brief, participants will consume a commercially available energy drink specifically formulated to improve cognitive performance with the standard dose of Cognizin, a reduced dose of Cognizin, a reduced dose of caffeine and Cognizin, or a placebo (water, which will be carbonated, matched for flavor, mouthfeel, etc.), then complete a battery of computer-based cognitive performance test, tasks in a video game (Tetris) to assess video game performance, have their resting metabolism analyzed, and then assessments of mood. Following a 1-week washout period, participants will return and consume one of the four remaining beverages and complete the same tasks. They will participate in four experimental visits, each time consuming a different beverage until they have consumed all beverages and completed all necessary tasks. Question(s) and Hypotheses (stated in null) Q: Does acute consumption of a new formulations (reduced active ingredients \[citicoline and caffeine\]) of a commercially available energy drink elicit similar improvements in cognitive performance, mood, energy expenditure and fat oxidation in young adults than the standard, currently marketed dose to formulation? H1: Acute consumption of the commercially available energy drink with standard dosing will improve cognitive performance compared to the reduced dose beverages and the placebo. H2: Acute consumption of the commercially available energy drink with standard dosing will improve gaming (Tetris) performance compared to the reduced dose beverages and the placebo. H3: Acute consumption of the commercially available energy drink with standard dosing will improve mood compared to the reduced dose beverages and the placebo. H4: Acute consumption of a commercially available energy drink with standard dosing will increase energy expenditure and fat oxidation compared to the reduced dose beverages and the placebo.

Conditions

Cognitive Performance, Gaming Performance, Blood Pressure, Heart Rate, Mood

Nasal Foralumab in Patients with Non-Active Secondary Progressive Multiple Sclerosis
Description

Only subjects that have completed TILS-021, a Phase 2a Randomized, Double-Blind, Placebo-Controlled, Multicenter Dose-Ranging Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients are eligible to be enrolled in TILS-022. TILS-022 is a 6-month open-label extension study with an opportunity for dose to be escalated based on the subject's clinical status. All subjects initiate dosing in this trial at a dose of nasal foralumab 50 µg 3 days a week (Monday, Wednesday, and Friday) for 2 weeks, followed by a 1-week rest, comprising a 3-week cycle. At week 12, the dose may be escalated to 100 µg according to pre-defined dose escalation rules. Study TILS-022 is intended to ensure all participants in TILS-021, a placebo-controlled study, will be able to receive open-label nasal foralumab for 6 months. The option to extend this trial for longer than 6 months will be explored with FDA by the Sponsor.

Conditions

Non-Active Secondary Progressive Multiple Sclerosis

Effectiveness of Scaling and Root Planing in Deeper Pockets
Description

This study will retrospectively evaluate the outcomes of scaling and root planing over a two year time period. The study will focus specifically on the effectiveness of SRP in pockets with an initial pre-treatment pocket probing depth of ≥ 5 mm and ≤ 8 mm. The study will also examine the response to SRP of all initial pocket depths, i.e., those PPD that fall below or above those in the indicated range, to verify the findings of previous studies.

Conditions

Periodontal Disease, Periodontitis

Extending Basic Dental Care to Nursing Home Residents to Reduce Mouth Infections and Reduce the Incidence of Pneumonia, a Leading Cause of Death.
Description

The goal of this study is to learn if dental infection control treatment delivered to older adult nursing home residents at their place of residence will result in : * improved dental health * reduced risk of pneumonia * better glucose control for diabetic patients compared to the pre-project dental and general health evaluations of residents and the pre-project facility incidence of pneumonia. Dental infection control treatment includes treating gum infections, stopping or slowing decay with fluoride, and assisting residents with effective tooth brushing and denture cleaning daily. Previous studies indicate dental infections can be inhaled and cause pneumonia or make diabetes worse. A shortage of dentists has limited care for nursing home residents. This project will allow dental hygienists and specially trained dental assistants to treat nursing home residents using telehealth methods (computers, cameras, internet, and telephone) to talk and work with dentists in different locations.

Conditions

Periodontitis, Gingivitis, Periodontal Disease, Periodontal Infections, Oral Infections, Periapical Infections, Pneumonia, Diabetes

Telehealth-Delivered Gut-Directed Hypnotherapy for Managing GI Health
Description

This study aims to evaluate the specific and non-specific effects of hypnotherapy and to evaluate the efficacy of group-format gut-directed hypnotherapy (GDH) delivered via telehealth for managing gastrointestinal health.

Conditions

Gastrointestinal Disease, Gastrointestinal Disorders, Nervous System

A Study of Bimagrumab Alone (LY3985863) and Bimagrumab With Tirzepatide (LY900042) in Healthy Participants
Description

The main purpose of this study is to evaluate the body concentration of different forms of bimagrumab, administered alone or with tirzepatide. Participation in the study will last about 4.5 months, including screening and follow-up.

Conditions

Healthy