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NCT ID: NCT04733664 Completed - Clinical trials for End Stage Renal Disease

Pilot Study to Evaluate Safety, Tolerability, and Performance of the FAST PV Technology™ in Chronic Dialysis Patients

Start date: October 29, 2020
Phase: N/A
Study type: Interventional

The FAST Plasma Volume (PV) Technology will aid in determining the plasma and interstitial volumes of end stage renal disease patients before and after dialysis therapy, providing a more precise understanding of pre and post dialysis volumes and extent of volume removal during the course of treatment.

NCT ID: NCT04732949 Completed - COVID-19 Clinical Trials

Study to Assess Efficacy and Safety of Inhaled Interferon-β Therapy for COVID-19

SPRINTER
Start date: January 12, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery of hospitalised patients receiving oxygen with confirmed Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). Safety and other efficacy endpoints will also be assessed.

NCT ID: NCT04732819 Completed - COVID-19 Vaccines Clinical Trials

Improving COVID-19 Vaccine Uptake in Nursing Homes

Start date: December 21, 2020
Phase: N/A
Study type: Interventional

SARS-CoV-2 vaccine, now being administered to skilled nursing facility (SNF) residents and staff, has highly variable acceptance between facilities. The investigators need to develop and disseminate effective strategies to increase vaccination immediately. For SNF residents and staff, the investigators will develop and implement a scalable multi-pronged intervention that educates, builds trust and supports the informed consent process aimed to increase SARS-CoV-2 vaccination. The investigators will conduct a cluster randomized trial to compare the effect of electronic messaging and education (i.e., usual care) versus a multi-pronged 'high touch' intervention to reduce vaccine hesitancy in skilled nursing facility staff and residents among a random sample of facilities across four SNF chains. As part of the 'high touch' intervention, the investigators will identify and train local opinion leaders. The investigators will offer these leaders assistance through real-time support for questions and provide consenting specialists. During the second wave of vaccination, the investigators will provide the intervention facilities with positive reinforcement for staff and will identify local champions to garner support and empowerment of staff. Finally, in the intervention facilities, the investigators will provide additional funds to support COVID-19 testing, in order that facilities have access to enough testing kits for patient or staff who develops symptoms following vaccination. This trial will be randomized within four SNF chains in order to evaluate the effect of a multi-pronged strategy to improve SARS-CoV-2 vaccine acceptance among direct care staff and long-stay nursing home residents. In four chains, eligible facilities will undergo randomization between usual care versus adding the 'high touch' intervention, implemented in two waves. Randomization and roll out of the intervention will occur at the facility level. The investigators hypothesize that: (1) the intervention will increase vaccination of SNF residents by at least 10 percentage points versus facilities usual care alone; (2) staff of SNFs with the intervention will have at least a 10 percentage point greater vaccine uptake of vaccine than staff in SNFs that do not participate in the high touch intervention; and (3) within intervention SNFs, improvements in vaccine uptake will be similar across staff and resident race/ethnicities.

NCT ID: NCT04732728 Completed - Atrial Fibrillation Clinical Trials

LUX-Dx Insertable Cardiac Monitor Remote Programming and Performance Study

LUX-Dx PERFORM
Start date: March 5, 2021
Phase:
Study type: Observational [Patient Registry]

The LUX-Dx PERFORM Study will characterize, in a general patient population, the utilization of the remote programming feature of the Boston Scientific (BSC) Insertable Cardiac Monitor (ICM) device. The study will also collect data to characterize the performance of arrhythmia detection algorithms. Finally, data collected will be used to analyze and characterize the ICM system-related safety events.

NCT ID: NCT04732715 Completed - Clinical trials for Caregiver Stress Syndrome

Caregiving and Racial Considerations During a Pandemic Online Training Education

CaRE
Start date: October 25, 2021
Phase: N/A
Study type: Interventional

The overall goal of this project is to develop and prototype-test a highly accessible program designed to enhance the mastery of Black American caregivers to provide care to family members or friends living with a dementia illness in a time of crisis. Participants will be asked a series of questions in a baseline interview, and then will be asked to partake in the CaRE course during a 6 to 8-week period.

NCT ID: NCT04732338 Completed - Headache Clinical Trials

The Effectiveness of Osteopathic Manipulative Medicine in the Management of Headaches Associated With Post Concussion Syndrome

Start date: August 1, 2017
Phase: Early Phase 1
Study type: Interventional

Pilot study looking at the Osteopathic Manipulative Treatment (OMT) for various headache types in patients with post-concussion syndrome (PCS). Twenty-six subjects with symptoms lasting >3 months were enrolled and were randomly assigned to a treatment group (n = 13) and a control group (n = 13).

NCT ID: NCT04732247 Completed - Inflammation Clinical Trials

Oxytocin for Oxidative Stress and Inflammation

Start date: February 1, 2022
Phase: Phase 2
Study type: Interventional

Naval Special Warfare (NSW) operators are exposed to a variety of extreme environmental conditions and intense physical demands. In addition to breathing high pressure gases at depth, prolonged cold water immersion and inadequate recovery from sustained physical exertion negatively impact individual and team performance. Biotechnologies that could mitigate the effects of cold as well as support physical recovery represent a significant unmet need for the NSW operational community. Oxytocin (OT) has a wide range of actions both locally in the brain and peripherally in the body including skeletal muscle. These peripheral effects can be mediated by classic ligand-receptor activation given the abundant expression of the oxytocin receptor in peripheral tissues, along with local expression of OT in peripheral tissues where it is likely to act in an autocrine manner. Exogenous OT via intranasal administration is FDA Investigational New Drug (IND)-approved and has been demonstrated as an easy and safe method to increase circulating OT concentrations that may augment actions on peripheral tissues. Due to the pleiotropic effects of OT on whole body metabolism, thermogenesis, stress responses, pain, mood, inflammation, appetite, glycemic control, skeletal homeostasis, and skeletal muscle repair and regeneration, there is increasing interest in the administration of exogenous OT for benefits to human health, performance and resilience. However, the biological mechanisms by which OT exerts tissue-specific effects (e.g., skeletal muscle) remain poorly understood, particularly in humans. This project is designed to significantly advance this understanding while testing the central hypothesis that intranasally administered OT attenuates systemic and skeletal muscle oxidative stress and inflammation induced by the combined stressor of resistance swim exercise and hyperoxia.

NCT ID: NCT04732195 Completed - Cystic Fibrosis Clinical Trials

Pilocarpine Microneedles for Sweat Induction (PMN-SI)

Start date: January 20, 2022
Phase: N/A
Study type: Interventional

The investigators want to test in this non-randomized clinical trial a new method of administrating Pilocarpine medicine into the skin during the Sweat testing process that does not use any electrical current.

NCT ID: NCT04731935 Completed - Opioid-use Disorder Clinical Trials

Novel Earpiece for Transcutaneous Auricular Neurostimulation (tAN) for Symptoms of Opioid Withdrawal

Start date: March 18, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate whether tAN via the tragus (vagal) and auriculotemporal (trigeminal) nerve pathways results in a clinically meaningful reduction in opioid withdrawal symptoms.

NCT ID: NCT04731922 Completed - Clinical trials for Healthy Participants

A Study of TAK-510 in Healthy Adults

Start date: February 3, 2021
Phase: Phase 1
Study type: Interventional

This is a study of TAK-510 for people with symptoms of feeling sick (nausea) or being sick (vomiting). The main aims of the study are to check if healthy adults have side effects from TAK-510 and to check how much TAK-510 they can receive without getting side effects from it. The study will be in 3 parts. Participants will take part in only 1 of the 3 parts of the study. At the first visit, the study doctor will check if each person can take part. For those who can take part, they will be placed in 1 of many small groups. The 1st groups will join Part 1 of the study, the 2nd groups will join Part 2 and the 3rd groups will join Part 3. They will receive an injection under the skin of either TAK-510 or placebo. In this study, a placebo will look like the TAK-510 injection but will not have any medicine in it. In Part 1, the 1st group of participants will receive 1 injection of either TAK-510 or placebo. Different participants within this group will receive lower to higher doses of TAK-510. The participants in this group will stay in the clinic for 4 days after their injection for some tests and check for any side effects from their treatment. In Part 2, the 2nd group of participants will receive an injection of either TAK-510 or placebo, once a day for 5 days. Different participants within this group will receive lower to higher doses of TAK-510. The participants in this group will stay in the clinic for 9 days after their 1st injection for some tests and check for any side effects from their treatment. In Part 3, the 3rd group of participants will visit the clinic 2 times. At the 1st visit, they will receive an injection either of TAK-510 or placebo, once a day for 7 days. Each participant in this group will receive lower to higher doses of TAK-510. They will stay in the clinic for 8 days after their 1st injection for some tests and check for any side effects from their treatment. At the 2nd clinic visit, each participant will receive 1 single injection of TAK-510 or placebo. This will happen 7 days after their last injection from the previous clinic visit. They will receive the same dose as their previous dose. They will stay in the clinic for 3 days for some tests and check for any side effects from their treatment. After treatment, all participants in the study will return to the clinic for a weekly check-up visit for up to 3 weeks.