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NCT ID: NCT06089707 Recruiting - Opioid Use Disorder Clinical Trials

Behavioral Pharmacological Examination of a Novel Buprenorphine Induction Method Among Individuals Who Use Fentanyl

NBIM
Start date: January 9, 2024
Phase: Phase 3
Study type: Interventional

The opioid overdose epidemic has persisted for several decades and is now further complicated by the permeation of fentanyl into the illicit opioid supply. While the effectiveness of medications to treat opioid use disorder (MOUD) have been well documented in the literature, the addition of fentanyl to the drug supply has complicated the initiation of MOUD, especially buprenorphine. Naloxone, an opioid antagonist, is currently utilized to reverse opioid overdose by displacing less-competitive ligands which bind at the mu-opioid receptor. Because induction to buprenorphine in the age of fentanyl is uncomfortable and can take several days to stabilize a patient on a therapeutic dose, the use of naloxone prior to buprenorphine can aid in a safe and rapid transition to buprenorphine treatment, without the effect of unintended prolonged precipitated withdrawal which can occur following the displacement of fentanyl by buprenorphine on the mu-opioid receptor. Therefore, this project will assess feasibility and acceptability of naloxone-facilitated buprenorphine initiation using a single-ascending dose design. The investigators will examine whether a single dose of buprenorphine is tolerated following administration of naloxone among a small group of individuals. If the dose is tolerated, the investigators will administer a larger dose among another small group of individuals. The investigators will examine the tolerability of up to 4 doses of buprenorphine following naloxone. This buprenorphine induction method has been characterized in case studies but it has not been evaluated in an empirical, systematic way in a controlled setting. This study will take place within an residential facility at Johns Hopkins Bayview Medical Campus, and will have immediate, real-world applicability in establishing a rapid, safe, and effective option to transition people with chronic fentanyl use to buprenorphine treatment.

NCT ID: NCT06089694 Completed - Heart Failure Clinical Trials

Crome/Cobalt Respiration Study

Start date: November 21, 2023
Phase:
Study type: Observational

The goal of this study is to compare measured respiration rates in various subject scenarios and use conditions between capnography and the Crome and Cobalt ICD and CRT-D MRI SureScan devices (derived using a Holter recorder).

NCT ID: NCT06089525 Recruiting - Pilon Fracture Clinical Trials

Treatment of Complex Pilon Fractures

Start date: August 25, 2023
Phase:
Study type: Observational

This project intends to compare patient outcomes between patients undergoing ORIF compared to PA, or ankle fusion, following an acute pilon fracture. Limited literature comparing ORIF and ankle fusion as a primary procedure exists. Particularly, no present literature exists examining the novel arthrodesis surgical technique utilized in this study in conjunction with Opal sensor gait analysis data. This study will serve as a pilot study and assess patient gait, degree of pain, functional outcome scores, development of post-traumatic arthritis and/or infection, need for secondary surgery, and return to work time.

NCT ID: NCT06089499 Not yet recruiting - COPD Clinical Trials

Palliative Care Health Literacy Education and QOL Compared to Usual Care

PACED
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot randomized controlled trial is to compare health literacy (HL) and quality of life (QOL) among older adults with chronic obstructive pulmonary disease (COPD) who completed a series of standardized palliative care (PC) educational video learning modules to usual care (US). The main question[s] it aims to answer are: Between Groups: - What effect does completing a series of standardized PC education video learning modules have on HL among older adults with COPD treated in the emergency department (ED) compared to usual care? - What effect does completing a series of standardized PC education video learning modules have on QOL among older adults with COPD treated in the ED compared to usual care? Within Groups: - What is the change from baseline to study completion for older adults with COPD who receive the educational intervention series of PC learning modules on HL? - What is the change from baseline to study completion for older adults with COPD who receive the educational intervention series of PC learning modules on QOL? - What is the change from baseline to study completion for older adults with COPD who receive UC on HL? - What is the change from baseline to study completion for older adults with COPD who receive UC on QOL? All participants will complete a baseline and study completion health literacy questionnaire (HLQ) and Medical Outcomes Study: Short Form 36 survey. The treatment group will view one standardized learning module per week for four weeks provided by Get Palliative Care and log their weekly completion in REDCap. The control group will receive usual COPD care. Researchers will compare the treatment group receiving weekly palliative care education to usual care to see if HL and QOL change.

NCT ID: NCT06089460 Active, not recruiting - Health Behavior Clinical Trials

Longitudinal Examination of Metabolic and Behavioral Correlates of Protein Sources

Start date: January 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this three-arm, pilot, randomized controlled trial is to examine the metabolic and behavioral impacts of consuming a diet characterized by protein from red meat, a meat analogue, or beans/legumes.

NCT ID: NCT06089434 Recruiting - Dysphagia Clinical Trials

TEE and Dysphagia in Lung Transplantation

Start date: June 2024
Phase: N/A
Study type: Interventional

The primary outcome of this study is dysphagia (difficulty swallowing) on postoperative speech and swallow evaluation following lung transplantation. Transesophageal echocardiography (TEE) (creates pictures of the heart from inside the participants body) is routinely performed for all lung transplantations at the University of California, Los Angeles (UCLA) and it is the standard of care. Patients are randomized to two groups. The intervention group would limit the number of TEE clips (# pictures taken) per case. The control group would leave the number of TEE clips to the discretion of the attending anesthesiologist. The investigators hypothesize that reduction in TEE imaging during lung transplantation will reduce dysphagia.

NCT ID: NCT06089408 Recruiting - Clinical trials for Malignant Solid Neoplasm

Weighted Blanket Use to Reduce Anxiety in Oncology Patients

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

This clinical trial compares the effect of using weighted blankets versus regular blankets during first time infusions (e.g. chemotherapy, targeted therapy etc.) to decrease adverse side effects such as anxiety and distress in cancer (oncology) patients. Feeling safe, comforted, and grounded in the world are some of the benefits noted by individuals who use weighted blankets. Deep touch pressure (DTP) has been found to reduce symptoms of stress and anxiety and is defined as a sensation one feels when being hugged, squeezed, or held. DTP affects the nervous system by creating a calming effect which may lower stress and increase feelings of well-being. The use of weighted blankets may help to manage anxiety and distress during chemotherapy or immunotherapy infusions.

NCT ID: NCT06089304 Completed - Clinical trials for Coronary Artery Disease

Patient Centered Machine Learning Model for Bleeding and Ischemic Risk

xDAPT
Start date: May 2008
Phase:
Study type: Observational

Dual antiplatelet therapy (DAPT) is indicated in all patients undergoing coronary stent implantation to prevent ischemic recurrencies despite an increased risk of bleeding. Accordingly, clinical practice guidelines advocate tailoring DAPT duration according to the patient's individual ischemic and bleeding risk profile. Data from 11 clinical trials involving patients who underwent percutaneous coronary intervention (PCI) with an everolimus-eluting stent will be pooled and analyzed to develop a machine learning-based algorithm to predict the probability of an ischemic or bleeding event up to 1 year. These predictive risk models aim to support clinical decision-making on DAPT management after PCI.

NCT ID: NCT06089291 Enrolling by invitation - Clinical trials for Total Knee Arthroplasty

Persona IQ Cohort Study

Start date: February 20, 2024
Phase:
Study type: Observational

A prospective multicenter longitudinal cohort study of Zimmer Biomet (ZB) Persona IQ The Smart Knee which consists of the Persona Personalized Knee (PPK) System with mymobility® platform that is attempting to develop correlative measures to assist surgeons in understanding and managing risk in their patient populations. Specifically comparing four outcome measures captured via Remote Therapeutic Monitoring (RTM) utilizing the CANARY canturioTM Tibial Extension (CTE) sensors in combination with the mymobility® App. The primary objective of this prospective study is to systematically document the clinical outcomes of the Persona IQ Personalized Knee System with mymobility for primary total knee arthroplasty/replacement (TKA/TKR). This will be accomplished by monitoring subject activity trend patterns via the mymobility platform, evaluating smart system usability, monitoring short and long-term safety and effectiveness, and evaluating the value of the remote therapeutic monitoring platform. This data collection will be accomplished by the following: 1. The Canary Smart Tibial Stem comprised of the following subsystems: 1. Canary Cloud Data Management Platform (CDMP) 2. Canary Medical Gait Parameters (CMGP) Software Module 2. Persona IQ Personalized Knee System with mymobility Platform comprised of the following subsystems: 1. mymobility Platform for Patient Application 2. mymobility Care Team Dashboard 3. ZB Edge Artificial Intelligence Data Platform 3. Clinical Outcomes 1. Joint Motion: ROM and Deductions 2. Joint Stability: Medial/Lateral and Anterior/Posterior 3. Gait and Assistive Device Utilization 4. Surgical Incision Site 4. Objective Measurements: a. Timed Up & Go (TUG) and Stair Climb Test 5. System Usability Evaluation 6. Patient Satisfaction 7. Health Care Provider Satisfaction Additionally, a data repository will be maintained for future secondary data analyses when data is transmitted and captured beyond the 1-year of follow-up.

NCT ID: NCT06089239 Recruiting - Patient Safety Clinical Trials

De-Implementing Fall Prevention Alarms in Hospitals

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

This is a Hybrid II de-implementation study to reduce use of fall prevention alarms in hospitals. The intervention consists of tailored, site-specific approaches for three core implementation strategies: education, audit/feedback and opinion leaders. Hospital units will be randomized to low-intensity or high-intensity coaching for the implementation of the tailored strategies.