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NCT ID: NCT05297578 Completed - Clinical trials for Pneumococcal Vaccines

Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults

Start date: June 15, 2022
Phase: Phase 2
Study type: Interventional

The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 65 years of age and older.

NCT ID: NCT05297565 Completed - Melanoma Clinical Trials

A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection

CheckMate-6GE
Start date: August 3, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.

NCT ID: NCT05297071 Completed - Healing Wound Clinical Trials

Longitudinal Monitoring of Microsurgical Socket Augmentation Healing With Ultrasonography

Start date: March 22, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to assess healing after tooth extraction with simultaneous socket augmentation (bone grafting during the same appointment as the extraction) when the surgeon uses a surgical microscope, compared to when the surgeon uses dental loupes (magnifiers that are mounted on the surgeon's glasses). These devices magnify and shine light on the area where the surgeon operates.

NCT ID: NCT05296824 Completed - Clinical trials for Paroxysmal Atrial Fibrillation

Cryoballoon PVI With PWI Versus PVI Alone In Patients With PAF

Start date: January 1, 2014
Phase:
Study type: Observational

Cryoballoon ablation has emerged as a safe and effective strategy for treatment of atrial fibrillation (AF) for which it has recently received a 'first-line' therapy indication by the FDA. Pulmonary vein (PV) isolation (PVI) has been the cornerstone of this procedure achieving freedom from recurrent AF in up to ~80% of patients at 12 months of follow-up. However, the success has been shown to be significantly lower, in the range of 50-60% at 3-5 years of follow-up. Other more recent cryoballoon ablation studies have demonstrated marked improvements in clinical outcomes associated with concomitant PVI and cryoballoon ablation/isolation of the 'PV component' (a region of the left atrial posterior [back] wall lying between the PVs that is anatomically and embryologically related to the PVs), versus PVI alone in patients with persistent AF. PVI+PWI using cryoballoon ablation has been widely-practiced in patients with paroxysmal AF. However, the acute/long-term safety and efficacy of this approach has not been formally investigated in paroxysmal AF. Given the mechanistic similarities between persistent and paroxysmal AF, we hypothesize that similar benefits associated with PVI+PWI may also be observed in those with paroxysmal AF. Yet, due to the relative infrequency of breakthrough/recurrent arrhythmias in patients with PAF, to detect a significant difference, large sample sizes and extended follow-up (>24 months) are likely needed. Hence, the aim of this retrospective, observational study is to examine the acute and long-term efficacy and safety beyond 36 months of follow-up associated with PVI alone versus PVI+PWI using cryoballoon ablation in a large cohort of patients with PAF, performed by a single operator (A. Aryana) between 1/1/2014 and 8/31/2018 at Mercy General Hospital.

NCT ID: NCT05296733 Completed - Healthy Clinical Trials

A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver Problems and (2) Find Out How People With Overweight and Obesity, With and Without Liver Problems, Tolerate Different Doses of BI 456906

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

This study is open to adults who have different levels of liver problems and adults who are healthy. People with or without overweight or obesity can take part. This study has 2 parts. The purpose of Part 1 is to find out whether having liver problems influences how BI 456906 is taken up in the body. The purpose of Part 2 is to find out whether having liver problems influences how people with overweight and obesity tolerate different doses of BI 456906. In Part 1, participants get a single injection of BI 456906 under their skin and stay at the study site for 2 nights afterwards. They are in the study for about a month. During this time, they visit the study site about 8 more times. The doctors compare the amount of BI 456906 in the blood of healthy people and people with liver problems. In Part 2, participants get 1 or 2 injections of BI 456906 once a week under their skin for 28 weeks. At the beginning, they get lower doses of BI 456906. Over time, they get higher doses until they reach a certain dose of BI 456906. This dose is then maintained until the end of the treatment. Participants in Part 2 are in the study for about 7 months. During this time, they visit the study site about 16 times and get about 15 phone calls from the site staff. The doctors record the number of people with health problems that could have been caused by treatment with BI 456906. They compare the results between participants with liver problems and those without liver problems. In both parts, doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT05296629 Completed - Clinical trials for Papulopustular Rosacea

A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea.

MVOR-1
Start date: March 14, 2022
Phase: Phase 3
Study type: Interventional

This is a 16-week, multicenter, randomized, parallel-group, double-blind, controlled study. After assessing eligibility during a screening period of up to 30 days, approximately 320 subjects at least 18 years old who are diagnosed with moderate to severe papulopustular rosacea will be randomized in a 3:3:2 ratio to DFD-29 (40 mg), Doxycycline capsules 40 mg, or Placebo once daily for 16 weeks.

NCT ID: NCT05296473 Completed - ADHD Clinical Trials

Guided ADHD Therapy for Managing the Extent and Severity of Symptoms

GAMES
Start date: May 5, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to assess the safety and effectiveness of an at-home, game-based digital therapy for treating adult patients with Attention-Deficit/Hyperactivity Disorder (ADHD).

NCT ID: NCT05296382 Completed - Clinical trials for Relative Bioavailability

Bioavailability of Tebipenem (SPR994) Crushed Tablet

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

The purpose of this study is to measure the amount of the antibiotic, tebipenem (SPR994) that is bioavailable after crushing the tablet and administering through a feeding tube with and without tube feeds.

NCT ID: NCT05296330 Completed - Childhood Obesity Clinical Trials

Energy Balance Teens: A Measurement Error Approach to Estimating Energy Balance in Free-Living Adolescents

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

There is a critical need to develop an affordable, valid, and reliable techniques to assess free-living energy expenditure (EE), energy storage (ES), and energy intake (EI). The purpose of this project is to develop and evaluate statistical procedures to model, quantify and adjust for the measurement error of and consumer (e.g., Garmin) activity monitors and body composition scales to estimate EE and ES, and use the 'calibrated' values to estimate free-living EI.

NCT ID: NCT05296252 Completed - Clinical trials for Attention Disturbances

Attention and Achievement: A Mind Wandering Investigation

Start date: May 11, 2022
Phase: N/A
Study type: Interventional

This study assesses the impact of mind-wandering on reading and math.