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NCT ID: NCT06167746 Recruiting - Caregiver Stress Clinical Trials

iCare4Me Transitions

iCare4Me T
Start date: March 1, 2024
Phase: Phase 3
Study type: Interventional

The goal of this randomized controlled trial is to examine the effect of a virtual face-to-face health coach intervention to improve self-care among caregivers of hospitalized older adults during care transitions compared to web-based resource information alone to determine the effectiveness of each intervention. The main questions it aims to answer are: 1. compare the efficacy of the virtual health coaching intervention vs. web-based information alone in improving self-care in caregivers of hospitalized community-dwelling older adults with multiple chronic conditions (MCCs) who transition from hospital to home, 2. compare outcomes among Black/African American and White caregivers who receive the intervention vs. digital health information alone, and 3. explore the estimated the cost of the interventions and acute care resource use among patients of caregivers who received virtual intervention vs. digital health information alone. Participants who enroll will agree to enroll will: - be randomly assigned to either the health information group or the health coaching intervention plus health information group for six months, and - be asked to complete a baseline interview, a check-in call at one month post-hospital discharge, and two follow-up interviews at 3- and 6-months after enrollment. Researchers will compare the two groups of caregivers on the following outcomes: self-care, caregiver self-efficacy (aka confidence), coping, stress, and health status.

NCT ID: NCT06167733 Recruiting - Clinical trials for Erectile Dysfunction

Safety and Efficacy of the VERTICA® RF Device for the Treatment of ED

Start date: November 29, 2023
Phase: N/A
Study type: Interventional

Adult subjects with mild to moderate and moderate ED who meet the study eligibility criteria will be enrolled in the study. The enrolled subjects will be randomized by a 1:1 ratio to receive the Active or Sham VERTICA® treatment. Baseline assessments will include collection of demographic data, medical history, concomitant medications and baseline clinical examinations. The initial treatment session will be performed in a clinical setting simulating home use to determine proper device use and to evaluate device tolerability, followed by continued home use of the device for a total of 6 months. Patients will be instructed to attempt sexual activity periodically over the course of the study. Every time a sexual intercourse is attempted, the patient will be requested to complete an event log using validated assessments. Patients will present for monthly follow-up visits, during which safety will be evaluated and additional efficacy assessments will be performed.

NCT ID: NCT06167707 Recruiting - Heart Failure Clinical Trials

Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers

Start date: April 19, 2024
Phase: Phase 1
Study type: Interventional

This study aims to compare the pharmacokinetics and pharmacodynamics of intravenous (IV) and subcutaneous (SC) furosemide. The test formulation in this study is furosemide injection, 80 mg/1 mL, buffered to a neutral pH for SC administration via an autoinjector. A commercial formulation of furosemide injection, USP, solution 10 mg/mL administered as a 40 mg IV injection over 2 minutes followed by a second dose of 40 mg, 2 hours later, will serve as the reference drug. The objectives of this study are: - To estimate the bioavailability and describe the pharmacokinetics and pharmacodynamics of furosemide administered as SC injection via autoinjector compared with equivalent dose of furosemide administered as two 40 mg IV injections, two hours apart. - To describe the safety and tolerability of furosemide administered as SC injection via an autoinjector.

NCT ID: NCT06167642 Enrolling by invitation - Multiple Sclerosis Clinical Trials

Retinal Atrophy and Neurofilament Light Chain in People With Multiple Sclerosis Taking Ofatumumab

Start date: May 22, 2023
Phase:
Study type: Observational

This study aims to assess whether, and the degree to which, ofatumumab modulates or reduces rates of retinal atrophy in people with relapsing-remitting MS (RMS), according to baseline serum neurofilament light chain (sNfL) levels.

NCT ID: NCT06167317 Recruiting - Clinical trials for Advanced Solid Tumors

Study of GS-0201 Alone and in Combination in Participants With Advanced Solid Tumors

Start date: January 9, 2024
Phase: Phase 1
Study type: Interventional

The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-0201 when given alone or in combination with sacituzumab govitecan (SG) in participants with advanced solid tumors. The primary objectives of this study are to: - To assess the safety and tolerability of GS-0201 as monotherapy and in combination with SG in participants with selected advanced solid tumors - To identify the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of GS-0201 as monotherapy and the MTD and/or the RP2D and dosing schedule of GS-0201 in combination with SG in participants with selected advanced solid tumors

NCT ID: NCT06167304 Recruiting - Chronic Pain Clinical Trials

Physical Therapy vs Remote Exercise for Knee Pain Due to Osteoarthritis (OA)

Start date: January 29, 2024
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to demonstrate that after six weeks of at home exercise, 3 times per week with SimpleTherapy, participants with clinical indications of knee OA will on average have improved outcomes noninferior than traditionally prescribed physical therapy regimens.

NCT ID: NCT06167291 Recruiting - Clinical trials for Oropharyngeal Neoplasms

Phase II Randomized-registry Embedded Study of Lymphoscintigraphy for Oropharyngeal Neoplasms to Enable Risk-adapted Nodal Guidance for Robotic Surgery and/or Radiotherapy (LONE-RANGR2)

Start date: April 19, 2024
Phase: Phase 2
Study type: Interventional

To test a new radiation treatment design based on where your cancer is located. Most participants with oropharyngeal cancer are treated with radiation to both sides of the neck. However, for participants with oropharyngeal cancer on one side of the neck, receiving radiation to both sides of the neck may result in increased side effects and radiation exposure. This study is testing the safety and effectiveness of an approach that involves radiation to only one side of the neck in an effort to reduce the overall amount of radiation given and decrease the amount of side effects you may experience.

NCT ID: NCT06167265 Completed - Clinical trials for Intermittent Claudication

BE Study of Once Daily PMR Compared to Twice Daily Cilostazol Tablets in Healthy Volunteers

Start date: November 28, 2023
Phase: Phase 1
Study type: Interventional

The study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation of extended-release tablet of cilostazol (PMR) administered once daily and the reference formulation of immediate- release tablet of cilostazol (Cilostazol) administered twice-daily in normal healthy male and female subjects under fasting conditions.

NCT ID: NCT06167161 Completed - Hearing Loss Clinical Trials

Clinical Investigation and Validation of a Self-fitted Air-conduction Hearing Aid

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

Approximately 48 million people in the United States have hearing loss or hearing difficulties in noisy environments. Concha Inc. is working on introducing a wireless air-conduction hearing aid to the market, featuring a self-fitting feature. Self-fitting hearing aids have emerged in recent years as a potentially viable option towards addressing unmet hearing health care needs for millions of individuals who suffer from mild-to-moderate hearing loss. The purpose of this study is to evaluate the efficiency and reliability of the self-fitting strategy developed by Concha Inc.

NCT ID: NCT06167096 Not yet recruiting - Skin Cancer Clinical Trials

Effects of Lavender Aromatherapy on Patient Anxiety During Mohs Micrographic Surgery

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

This study aims to improve patient comfort by exploring the potential of lavender aromatherapy in reducing anxiety and unpleasant odor perception during Mohs Micrographic Surgery (MMS). Lavender has been widely studied for its sedative-like properties and calming effects, both in medical and dental settings. By investigating the impact of lavender aromatherapy on patient anxiety levels during MMS, we seek to provide evidence-based insights into non- pharmacological interventions that can enhance the overall comfort and experience of participants.