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NCT ID: NCT05137236 Completed - SARS-CoV-2 Clinical Trials

A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters

Start date: December 6, 2021
Phase: Phase 2
Study type: Interventional

The main goal of Part A of this study is to assess the safety, reactogenicity, and immunogenicity of the study vaccine candidates. The main goal of Part B of this study is to assess the safety, reactogenicity, and immunogenicity of the mRNA-1283.529 booster vaccine candidate.

NCT ID: NCT05137223 Completed - Asthma Clinical Trials

BREATHE-Peds Pilot - I Focus Group Interviews

Start date: April 26, 2022
Phase:
Study type: Observational

The overall aims of this study are to develop and pilot test BRief intervention to Evaluate Asthma THErapy (BREATHE)-Peds, a dyadic shared decision-making intervention, to improve asthma by supporting self-management among racial and ethnic minority early adolescents receiving care for uncontrolled asthma in federally-qualified health centers (FQHCs) in urban communities. Aim 1 (Phase I) involves developing the intervention through focus groups with early adolescents and caregivers. Aims 2 and 3 (Phase II) involve preliminary testing of the intervention through a pilot randomized controlled trial. This record is for Phase I only.

NCT ID: NCT05137093 Completed - Atopic Dermatitis Clinical Trials

Scratching Validation Study

Start date: December 10, 2021
Phase:
Study type: Observational

Single center, analyst-blinded, study comparing the scratching events identified via an actigraphy scoring algorithm versus manual scoring of an overnight video recording, undertaken in a sample of 40 adult patients with atopic dermatitis and controls.

NCT ID: NCT05137067 Completed - Breast Cancer Clinical Trials

A Novel Approach for Alleviating the Side Effects of Chemotherapeutic Agents.

Start date: January 20, 2021
Phase: Phase 2
Study type: Interventional

This study will assess the effectiveness of a natural nutraceutical in treating the known side effects of chemotherapeutic agents in cancer patients.

NCT ID: NCT05137002 Completed - Clinical trials for Uncontrolled Hypertension

A Study of CIN-107 in Patients With Uncontrolled Hypertension

HALO
Start date: December 7, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, multicenter study to evaluate the efficacy and safety of multiple dose strengths of baxdrostat (also called CIN-107) in the treatment of patients with uncontrolled hypertension. The primary objective was to demonstrate that treatment with baxdrostat for 8 weeks would lower the systolic blood pressure (SBP) in patients who were hypertensive despite taking one or two anti-hypertensive medications. Participants were assigned to take placebo or baxdrostat once per day for 8 weeks while they continued taking the regular anti-hypertensive medications. At the end of the 8-week period, qualified patients could participate in Part II of the study and receive 2 mg baxdrostat for 4 weeks while they discontinued taking the background anti-hypertensive medication.

NCT ID: NCT05136898 Completed - Bladder Cancer Clinical Trials

Feasibility of Home Instillation of UGN-102 for Treatment of Low-Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC)

Start date: November 30, 2021
Phase: Phase 3
Study type: Interventional

This study aims to demonstrate that home instillation of UGN-102 is a feasible alternative to instillation in a clinical setting, which might mitigate some of the challenges in the patient experience (logistical, expense, and comfort) when receiving treatment for low-grade non-muscle-invasive bladder cancer at intermediate risk of recurrence (LG IR NMIBC).

NCT ID: NCT05136885 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

HEALEY ALS Platform Trial - Regimen E SLS-005 - Trehalose

Start date: February 21, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. Regimen E will evaluate the safety and efficacy of a single study drug, SLS-005 (Trehalose injection, 90.5 mg/mL for intravenous infusion) in participants with ALS.

NCT ID: NCT05136729 Completed - Clinical trials for Chronic Low-back Pain

The Effects of Self-Natural Posture Exercise Programs on Chronic Low Back Pain

Start date: January 17, 2022
Phase: N/A
Study type: Interventional

Low back pain is a major health problem across the United States, with socio-economic burden, major cause of disability, and poor quality of life. One such non-pharmacologic treatment is Self-Natural Posture Exercise (SNPE), a series of exercise programs developed in conjunction with orthodontic bracing principles. Belts are worn around the hips (pelvic correction belt) and legs (right posture belt) to assist with self-directed exercise and posture correction. A typical SNPE program has eight different movements, targeting the entire axial skeleton. The exercises can be practiced anywhere and are widely applicable to patients as exercises are low- to moderate-intensity flexibility-based muscle strength training. There are several studies from Korea examining the efficacy of SNPE; however, there are few English language studies and there are no studies from outside the country of South Korea. As such, there is little data the generalizability of SNPE, the degree of cultural acceptance in other countries, and the all-important adherence to the home exercise program. The present study proposes to be the first study outside of South Korea to examine the effects of SNPE on chronic low back patients.

NCT ID: NCT05136690 Completed - Clinical trials for Cognitive Impairment Associated With Schizophrenia

Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334-007)

Start date: April 27, 2022
Phase: Phase 1
Study type: Interventional

The primary purpose of this randomized, double-blind, placebo-controlled cross-over study is to record and measure 40 Hz-auditory steady-state response (ASSR) in healthy controls (HC) and participants with mild-to-moderate schizophrenia (SZ) to determine if the mean inter-trial coherence (ITC) magnitude derived from the 40 Hz-ASSR is lower in SZ than in HC at baseline.

NCT ID: NCT05136443 Completed - Corneal Edema Clinical Trials

Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection

Start date: November 23, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess off-label use of loteprednol etabonate 0.25% ophthalmic suspension (Eysuvis) for prevention of immunologic rejection in the first year after Descemet membrane endothelial keratoplasty (DMEK). Topical corticosteroids have long been the mainstay for preventing and treating cornea transplant rejection although none are specifically approved for this purpose. The rates of immunologic rejection episodes and steroid-induced ocular hypertension will be compared with the respective rates observed in earlier studies with prednisolone acetate 1% suspension, loteprednol etabonate 0.5% gel, and fluorometholone 0.1% suspension after DMEK.