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NCT ID: NCT05059223 Completed - Narcolepsy Clinical Trials

A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy

SYMPHONY
Start date: September 15, 2021
Phase: Phase 3
Study type: Interventional

This study is a multi-center, double-blind, placebo-controlled, randomized Phase 3 trial to assess the safety and efficacy of AXS-12 in narcoleptic subjects with cataplexy and excessive daytime sleepiness (EDS).

NCT ID: NCT05059132 Completed - Lung Neoplasm Clinical Trials

Inspiratory Muscle Training and Behavioral Support to Alleviate Dyspnea and Promote Walking in Lung Cancer Survivors: A Pilot Study

Start date: January 10, 2022
Phase: N/A
Study type: Interventional

This is a pilot randomized study to investigate the feasibility, acceptability, safety, and effects of a novel tele-rehabilitation intervention for stage I-IIIA lung cancer survivors following curative intent therapy. The specific aims and hypotheses are: Specific Aim 1: Conduct a pilot, phase IIb, parallel randomized (1:1) study to investigate the feasibility, acceptability, and safety of inspiratory muscle training and behavioral support to promote walking in tele-rehabilitation with stage I-IIIA lung cancer survivors following curative intent therapy (N=40). Hypothesis 1a: ≥ 20% eligible patients will enroll; ≥75% of participants will achieve ≥75% adherence to the tele-rehabilitation program. Hypothesis 1b: ≥75% of participants will perceive tele-rehabilitation as acceptable (Telemedicine Satisfaction and Usefulness Questionnaire ≥4). There will be 0 intervention adverse events. Specific Aim 2: Explore the effects of the tele-rehabilitation program (N=40). Hypothesis 2: At 12 weeks, participants in the tele-rehabilitation (experimental) arm, compared to education only (control) arm, will have a trend of greater improvements in outcomes, including: 1. accelerometry-measured physical activity (primary outcome); and 2. functional capacity, self-reported physical activity, control of dyspnea and anxiety symptoms, sleep quality, and quality of life (secondary outcomes).

NCT ID: NCT05058729 Completed - Clinical trials for Multiple Sclerosis (MS)

MS PATHS COVID-19 Questionnaire Data Linkage Sub-Study

Start date: December 7, 2020
Phase:
Study type: Observational

The primary objective of this sub-study is to supplement the Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS) dataset with coronavirus disease 2019 (COVID-19)-related health information obtained from periodic participant questionnaires administered by participating MS PATHS institutions.

NCT ID: NCT05058664 Completed - Suicide Clinical Trials

Developing Text-based Support for Parents of Adolescents After an Emergency Department Visit

Start date: November 8, 2021
Phase: N/A
Study type: Interventional

The researchers seek to develop a text message intervention for caregivers of adolescents at elevated suicide risk following discharge from emergency department (ED) care.

NCT ID: NCT05058430 Completed - Xerostomia Clinical Trials

SaliPen Human Factors Study for OTC Labeling

SaliPen
Start date: September 16, 2021
Phase: N/A
Study type: Interventional

This Human Factors Validation Testing will assess user interactions to verify the capability of potential users to assess if the study product fits their needs and if they can use it correctly based on the provided Information For User (IFU)? More specifically, this is a non-comparative case series study and is subdivided into two major parts. Those parts are: 1. Phase I: aimed at testing if, based on the IFU, the potential subjects can decide whether the study product is or is not appropriate to treat their condition and, 2. Phase II: aimed at assessing whether the users can use the study product correctly without counseling by a health care provider.

NCT ID: NCT05058209 Completed - Clinical trials for Osteoarthritis, Knee

Effect of ZILRETTA Versus CELESTONE on Quality of Life, Pain, Neuromuscular Function, and Physical Performance

Start date: November 30, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this study is to examine the pre, post, and follow up effects of a single ZILRETTA knee injection vs a single CELESTONE SOLUSPAN knee injection on physiological measure of self-reported quality of life, pain, physical function, and physical performance in individuals with osteoarthritis (OA) knee pain. The Primary Investigator (PI) will recruit 20 symptomatic knee OA patients for this study. Patients will be randomized into one of two treatment arms, Arm 1 (ZILRETTA injection) or Arm 2 (CELESTONE SOLUSPAN injection). Patients in Arm 1 will receive a single 5 mL IV injection of 32 mg ZILRETTA into the affected knee joint. Patients in Arm 2 will receive a 5ml IV injection of 6mg/ml CELESTONE SOLUSPAN into the affected knee joint. Each study arm will include 10 patients. All data will be collected prior to injection (baseline), as well as at 6-week (post 1) and 12-week follow-ups (post 2). Patients will blinded to treatment arm until after they complete their 12-week follow up.

NCT ID: NCT05057988 Completed - Pain Clinical Trials

Virtual Empowered Relief for Chronic Pain

Start date: September 8, 2021
Phase: N/A
Study type: Interventional

The purpose of the current pilot study is to examine a feasibility and the preliminary efficacy of Empowered Relief (ER) class when it is delivered 'virtually' to patients with chronic pain who take methadone or buprenorphine. The ER class is a single-session pain management class, which has demonstrated to be effective in improving pain and pain-related distress in patients with chronic low back pain, but its efficacy has not been examined in patients with chronic pain who take methadone or buprenorphine. Class participants will learn self-regulatory skills and develop a personalized plan to use the skills every day. The current study will examine a feasibility and participant's perception and satisfaction of this class at post-class. The study will also follow participants 3 months by administering 5 surveys (baseline, 2 weeks and 1 month, 2 months, and 3 months post-treatment) to determine whether the class confers the short-term and medium-term benefits across various aspects of health.

NCT ID: NCT05057780 Completed - Clinical trials for Resident Communication Skills Rated by Patients

Measuring the Impact of an Interactive Communication Skills Curriculum on Internal Medicine Residents

IMCOMM
Start date: November 20, 2017
Phase: N/A
Study type: Interventional

This study seeks to assess whether a novel method of teaching communication skills is effective in improving the communication skills of internal medicine residents. Effective communication is widely accepted as an essential skill in both clinical practice and post-graduate training. While the body of research on effective communication is maturing, training that incorporates this new data lags behind. Methodological difficulties inherent to the study of communication training programs further complicates the effort to create effective, evidence-based training programs for the next generation of practitioners. Cleveland Clinic has taught its internally developed relationship-centered communication model, the R.E.D.E. Model, to over 7000 providers in less than 5 years. While teaching this course, common communication themes emerged as areas where providers often "get stuck". This proposal details a cluster randomized educational study of a novel communication training curriculum that addresses 3 of the common communication themes that emerged and how those themes occur in multiple, different communication challenges. The curriculum will be delivered to 2nd and 3rd year internal medicine residents over three, 1-hr long training sessions. The investigators' primary aim is to test whether residents trained to identify and communicate through these themes will receive better scores on communication from patients seen in their general internal medicine clinic. The investigators will also assess the effect of this training on patient compliance and on management of common chronic diseases such as hypertension, depression, and diabetes. Lastly, the investigators will measure the effect of the training course on resident self-perceived burnout and empathy.

NCT ID: NCT05057754 Completed - Clinical trials for Carpal Tunnel Syndrome

Sonographic Measurement of Intraneural Blood Flow in the Median Nerve

Start date: December 13, 2021
Phase: N/A
Study type: Interventional

Carpal tunnel syndrome (CTS) is the most common nerve compression disease and the most expensive upper-extremity work-related musculoskeletal disorder, affecting approximately 10 million people in the US. To understand the clear etiology and mechanism of carpal tunnel syndrome, the measurement of median nerve intraneural blood flow needs to be further scrutinized as the common fluctuating physiological conditions and functional hand activities might contribute to the fluctuation of the measurement and serve as measurement error. This study aims to examine how intraneural blood flow within the median nerve is affected by physiological factors (i.e., body temperature and blood pressure) and functional hand activities (i.e., typing, using a mouse, and cooking).

NCT ID: NCT05057650 Completed - Nutrition Disorders Clinical Trials

Help Everyone Assess Risk Today: LEnten Nutrition Study (HEART-LENS)

Start date: March 3, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the impact of community health screening, health education and nutritional intervention on risk factors for cardiovascular disease in a predominantly African American population. The health fair and intervention will take place in a church that typically improves their lifestyle by "giving up for Lent" certain foods or habits. Participation in this nutrition intervention is voluntary and each participant will sign an informed consent along with a waiver. On the waiver, the participant can agree to have all testing performed but can withdraw consent at any time or decide to have only some of the testing. It was hypothesized that a community-based health screening and nutritional intervention will have a positive impact on the participants by: 1. Measuring baseline risk factors 2. Educating them about their individual risk for heart disease 3. Providing education on healthy lifestyle 4. Providing a nutritional intervention for 40 days with home- delivered plant-based meals nutrition that has been shown to lower cardiac risk factors 5. Repeating the risk factor assessment at the end of the intervention, to demonstrate the degree of, if any, reduction in cardiac risk as assessed by the American College of Cardiology/American Heart Association (ACC/AHA) Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator 6. Motivating at-risk subjects to seek continued appropriate medical care and to institute more permanent relevant lifestyle changes (e.g., diet, exercise, medication compliance).