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NCT ID: NCT04562597 Completed - Surgery Clinical Trials

A Pilot Trial to Determine the Effective N-acetylcysteine Dose for Opioid Reduction for Spine Surgery.

Start date: January 20, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Determine the optimal dose of IV N-acetylcysteine (NAC) to produce opioid reduction following spine surgery and estimate the difference in opioid consumption between placebo and the selected optimal dose.

NCT ID: NCT04562584 Completed - Oximetry Clinical Trials

Pulse Oximeter Hypoxia

Start date: June 3, 2020
Phase: N/A
Study type: Interventional

The aim of this project is to test the accuracy of pulse oximeters (devices intended to measure oxygen saturation in blood noninvasively) during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from 100 to down to 70%. This is done by comparing the reading of the pulse oximeter during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin (hemoglobin carrying oxygen) saturation, that is arterial blood sample processed in a laboratory.

NCT ID: NCT04562246 Completed - Covid19 Clinical Trials

SARS-CoV-2 IgG and IgM Serologic Assays

Start date: August 14, 2020
Phase:
Study type: Observational

The primary objective is to assess and validate the ability of the Beckman Coulter Access COVID-19 IgG and IgM assays to detect immunity in COVID-19 patients in the Henry Ford Hospital Health System.

NCT ID: NCT04562155 Completed - Clinical trials for Refractory and/or Unexplained Chronic Cough

Clinical Study to Evaluate the Efficacy and Safety of Three Different Doses of BAY1817080 Compared to Placebo in Patients With Chronic Cough

PAGANINI
Start date: October 2, 2020
Phase: Phase 2
Study type: Interventional

Researchers in this study want to find the optimal therapeutic dose of drug BAY1817080 for patients with long-standing cough with or without clear causes (refractory and/or unexplained chronic cough, RUCC). Study drug BAY1817080 is a new drug under development for the treatment of long-standing cough. It blocks proteins that are expressed by the airway sensory nerves which are oversensitive in patients with long-standing cough. This prevents the urge to cough. Researchers also want to learn the safety of the study drug and how well it works in reducing the cough frequency, severity and urge-to-cough. Participants in this study will receive either the study drug or placebo (a placebo looks like the test drug but does not have any medicine in it) tablets twice daily for 12 weeks. Observation for each participant will last about 18 weeks in total. Participants will be asked to wear a digital device to record the cough and to complete questionnaires every day to document the symptoms. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

NCT ID: NCT04562116 Completed - Atopic Dermatitis Clinical Trials

A Study to Assess the Effects of Nemolizumab on Cytochrome P450 Substrates in Participants With Moderate-to-Severe Atopic Dermatitis

Start date: May 24, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect of nemolizumab (CD14152) on the pharmacokinetics (PK) of a drug "cocktail" representative of CYP450 (CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4/5 sensitive index substrates) in adult participants with moderateto- severe atopic dermatitis (AD).

NCT ID: NCT04562038 Completed - Development Delay Clinical Trials

Implementation of Electronic Shared Decision-Making Support for Early Intervention

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

Family-centered care is a best practice approach to delivering high quality early intervention (EI) services for children 0-3 years old with developmental needs. Yet, family engagement in designing and monitoring their child's EI service plan is suboptimal. Families need a valid, reliable, and useful tool to share in decisions about the scope of their child's EI service plan. The investigators will achieve a major advance in contributing occupational therapy expertise to improve family engagement when designing and monitoring their child's EI services. The investigators will test the use of an evidence-based electronic tool with families at one EI program, when the child is due for an annual review of progress in the program. The investigators will also gather input from families, practitioners, and program leadership to identify facilitators and barriers to its use in multiple EI programs. This project tries to test an innovation in how the investigators deliver family-centered and participation-focused care. Study results will yield evidence for the effectiveness of the electronic intervention on parent activation, EI service plan focus, EI service use quantity, parent perceptions of EI service quality, and child functioning.

NCT ID: NCT04561778 Completed - Cardiomyopathies Clinical Trials

HIS-Purkinje Conduction System Pacing Optimized Trial of Cardiac Resynchronization Therapy

HOT-CRT
Start date: April 15, 2021
Phase: N/A
Study type: Interventional

This is a randomized, prospective, single-blinded trial to determine the overall rate of successful His-Purkinje conduction system pacing Optimized Trial of Cardiac Resynchronization Therapy (HOT-CRT) versus biventricular pacing using coronary sinus lead (BVP) to compare acute and mid-term outcomes. Acute outcomes include change in QRS duration pre-and post-pacing (degree of QRS narrowing) and incidence of major periprocedural complications (pericardial tamponade, need for lead revision, etc.). Mid-term outcomes include echocardiographic response at 6 months along with a composite clinical outcome of heart failure hospitalization, ventricular arrhythmias, crossover, and all-cause mortality.

NCT ID: NCT04561765 Completed - Chronic Pain Clinical Trials

Innovation in the Treatment of Persistent Pain in Adults With NF1: Implementation of the iCanCope Mobile Application- Clinical Trial

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

To demonstrate the initial feasibility and determine preliminary impact on clinical outcomes of the iCanCope-NF program in a pilot RCT. If successful this pilot study will support conducting a larger randomized control trial (RCT). The primary research question is what is the feasibility of the iCanCope-NF program? The investigators define feasibility as (1) rates of accrual and dropout, daily log-ins, engagement, and outcome measures completed and (2) perceptions regarding intervention acceptability and satisfaction; and what are the levels of engagement. log-ins, with the intervention? The secondary questions are: (1) how does the iCanCope-NF program compare with the control condition in differences of pain and pain-related activity limitations, sleep functioning, emotional functioning (depression, anxiety), opioid usage, pain catastrophizing, self-efficacy, respondent burden (i.e. Physical Functioning, R, Vitality, Social Functioning, Role-Emotional, and Mental Health), and psychological flexibility immediately post-treatment (T2), (2) does the iCanCope-NF + CM increase the engagement of the iCanCope-NF program as compared to iCanCope-NF without CM, and do their corresponding levels of pain and pain-related activity decrease with CM?, and (3) do individuals with NF1 utilize the MBAA to help reduce pain symptoms? The investigators hypothesize that by customizing and including MBAA to the program for adults with NF1, that individuals who engage regularly as seen through Analytics Platform for Evaluating Effective Engagement (APEEE) application, will acquire new sets of skills to facilitate pain management, while pain as reported with the Brief Pain Inventory will decrease.

NCT ID: NCT04561570 Completed - Cataract Clinical Trials

Long Term Outcomes of Vivity Intra Ocular Lens(IOL) Versus Control

REVIVE
Start date: September 17, 2020
Phase:
Study type: Observational

Evaluate the long-term (>1 yr) outcomes of the Vivity IOL. The investigator will use similar measurements and procedures to the ones performed on these subjects during the FDA clinical trial.

NCT ID: NCT04561544 Completed - Depression Clinical Trials

Pilot Test of a Cultural Intervention to Enhance Alaska Native Students' Behavioral Health

Start date: August 30, 2020
Phase: N/A
Study type: Interventional

This project aims to enhance AN university students' behavioral health by supporting their cultural identity development. While the connection between cultural identity and behavioral health is becoming clearer, comparably less research has explored methods of enhancing identity development. Consequently, the investigators will pilot a cultural identity development program for AN students at the University of Alaska Anchorage (UAA). This intervention is based on extant scientific literature, local findings from focus group with AN students, and traditional wisdom from AN Elders. The eight-week Elder-facilitated program incorporates storytelling, experiential learning, connection, exploration, and sharing of identity, cultural strengths, life paths, and rootedness in who they are in order to remain grounded when they face changes and challenges. Approximately 40 to 50 AN university students will be recruited for the intervention. Participants will be randomized, with half the participants receiving the intervention in the Fall 2020 semester and half the students receiving the intervention in the Spring 2021 semester. We hypothesize that engaging in this intervention will strengthen AN students' cultural identities, strengths, and sense of community; improve their behavioral health, as evidenced in higher self-reported wellbeing, and lower substance use, depression, anxiety, and suicidal ideation symptoms; and support their academic persistence and achievement. Outcomes will be tested via mixed design analyses of covariance. Moreover, program feasibility will be examined through a process evaluation, which will entail thematic analyses of six focus groups with program participants (n=40-50) and with the Elders who facilitated the program (n=5).