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NCT ID: NCT04786457 Completed - Dengue Clinical Trials

ADVP005; Dengue CVD 12000 - Dengue-1-Virus Live Virus Human Challenge (DENV-1-LVHC)

Start date: November 30, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this research study is to test the protection of volunteers previously vaccinated with Tetravalent Dengue Virus (TDEN) Purified Inactivated Vaccine (PIV) with alum and boosted with TDEN live attenuated vaccine (LAV) formulation against a weakened form of an experimental dengue virus challenge. The Investigators will also include people that have not received the study vaccine. The Investigators are collecting information about how the vaccine protects against a dengue virus challenge as well as adding to knowledge about the safety of the challenge.

NCT ID: NCT04786444 Completed - Clinical trials for Chikungunya Virus Infection

Study to Demonstrate Consistency of Three Lots of a Live-attenuated Chikungunya Virus Vaccine Candidate in Healthy Adults

Start date: February 22, 2021
Phase: Phase 3
Study type: Interventional

This was a prospective, randomized, double-blinded, multicenter Phase 3 clinical study investigating three Lots of VLA1553 at the final dose. Overall 409 healthy subjects aged 18 to 45 years were randomized into the study.

NCT ID: NCT04786340 Completed - Diabetes Mellitus Clinical Trials

A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy

Start date: November 20, 2020
Phase: Phase 2
Study type: Interventional

This is a 12 week, 2-arm, blinded, single-site, placebo-controlled Phase II study in subjects with Type II Diabetes and painful peripheral neuropathy.

NCT ID: NCT04786210 Completed - Keloid Scar Clinical Trials

Treatment of Keloids With Fractional Erbium Laser-Assisted 5-Fluorouracil Versus Laser-Assisted Corticosteroid

Start date: January 30, 2021
Phase: Phase 4
Study type: Interventional

This is a split-scar study with a target sample size of 20. There are two interventions: fractional erbium:YAG-assisted drug delivery of 5-fluorouracil and fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide. Patients will undergo treatments in a series of 4 treatments at approximately 4 week ± 1 week intervals. Investigators will monitor for safety and continued benefit after the end of the interventional treatment.

NCT ID: NCT04786184 Completed - COPD Clinical Trials

Capnography-Assisted Learned Monitored (CALM) Breathing Therapy for COPD

CALM
Start date: November 30, 2021
Phase: N/A
Study type: Interventional

This pilot study is part of a phased approach to refine, optimize, and test the feasibility of CALM Breathing. Preliminary participant feedback from the Capnography-Assisted Respiratory Therapy (CART) study was applied to adapt and design CALM Breathing (including its dose, schedule, delivery, and home program). This pilot builds on initial lessons learned and identifies intervention areas still needing greater development to assure the success of a future large trial, targeting a subpopulation at risk, that is, those with COPD and anxiety sensitivity.

NCT ID: NCT04786171 Completed - Copd Clinical Trials

4D Medical X-ray Velocimetry for Bronchoscopic Lung Volume Reduction Targeting

Start date: January 7, 2021
Phase:
Study type: Observational

This study will investigate the utility of 4D Medical's X-ray Velocimetry (XV) imaging analysis software for the detection of hyperinflation, and compare endobronchial valve placement outcomes with predictive indices obtained utilizing this technique.

NCT ID: NCT04785963 Completed - Chronic Pain Clinical Trials

Effect of Music and Other Audio Recordings for Chronic Pain in Aging Adults

Start date: February 23, 2021
Phase: N/A
Study type: Interventional

The long-range goal is to reduce suffering and establish alternative options for older adults experiencing pain. This is a randomized controlled study examining the effect of music on pain management in older adults.

NCT ID: NCT04785794 Completed - Influenza Vaccine Clinical Trials

Safety and Immunogenicity of the Sing2016 M2SR H3N2 Monovalent Influenza Vaccine in Adults Ages 50 to 85 Years Old

Start date: June 30, 2021
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled Phase 1b study to evaluate safety and immunogenicity of the investigational Sing2016 M2SR H3N2 influenza vaccine delivered intranasally to a healthy adult population age 50 to 85 years.

NCT ID: NCT04785690 Completed - Amblyopia Clinical Trials

CURESIGHT BINOCULAR AMBLYOPIA TREATMENT STUDY

Start date: March 31, 2021
Phase: N/A
Study type: Interventional

Screening A child is considered for the study after undergoing a standard of care and study specific eye examinations (by a study investigator as part of standard of care) that identifies amblyopia appearing to meet the eligibility criteria. The study will be discussed with the child's parent(s) or guardian(s) (referred to subsequently as parent(s)). Parent(s) who express an interest in the study will be given a copy of the informed consent form to read. Written informed consent / assent must be obtained from a parent and child prior to performing any study-specific procedures that are not part of the child's routine care. On screening visit, eligibility assessment, medical history,Demographic data, Refraction and Cycloplegia, Demonstration suitability using the CureSight, ATS Diplopia Questionnaire, Symptom Survey Distance VA Testing , Ocular Alignment Testing, Near VA Testing, Stereoacuity Testing-Randot, Stereoacuity Testing- Titmus Fly, Eye movement exams (optional), Contrast sensitivity (optional), Reading rest (optional) Randomization The EDC and data management will construct a Master Randomization List using a permutated block design stratified by initial visual acuity in the amblyopic eye and age which will specify the order of treatment group assignments. Randomization will be managed directly by the eCRF platform. All eligible subjects enrolled in the study will be followed for 16 weeks. Subjects will be randomly assigned in a 1:1 allocation to one of the following treatment groups for 16 weeks: 1. Binocular treatment 90 minutes per day, 5 days per week 2. Patching group: Patching 2 hours per day, 7 days per week. Follow up visits - 1-week phone call (4 to 8 days from randomization) to inquire about issues with the CureSight system (if applicable) and to encourage compliance with treatment for all groups (to be completed by site personnel) - Visit 2: 4 weeks ± 1 week - Visit 3: 8 weeks ± 1 week - Visit 4: 12 weeks ± 1 week - Visit 5: 16 weeks ± 1 week (primary endpoint) - Unmasking of primary outcome results - For each individual subject, clinician's decision regarding: Treatment or control cessation and follow-up; or, Control (patching) continuation with same modality (more improvement desired); or, Cross-over to a different treatment (avoid missing the optimal window of opportunity in young age) •Optional Visit 6: 28 weeks ± 1 week (exploratory outcome, including retainment of improvement; and additional exploratory outcomes

NCT ID: NCT04785638 Completed - Pain, Postoperative Clinical Trials

An Open-label Safety and Pharmacokinetic Study of INL-001 in Adults Following Various Open Soft-Tissue Surgeries

Start date: April 14, 2021
Phase: Phase 3
Study type: Interventional

This is a multicenter, Phase 3, open-label, safety, tolerability, and characterization of pharmacokinetics study of the INL 001 (bupivacaine HCl) implant, at 300 mg, in patients following various soft-tissue surgeries: open ventral hernia repair, abdominoplasty, open abdominal hysterectomy, laparoscopic-assisted colectomy, and reduction mammoplasty.