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NCT ID: NCT04740099 Withdrawn - Opioid Use Clinical Trials

Surviving Opioid Overdose With Naloxone Education and Resuscitation Trial (SOONER)

SOONER
Start date: December 2021
Phase: N/A
Study type: Interventional

Among people at risk of opioid overdose and receiving care in an academic emergency department, family practice, opioid substitution clinic or general inpatient units, does brief opioid overdose resuscitation training and naloxone distribution reduce resuscitation failures in a simulated overdose even, in comparison with standard-of-care referral to a local OEND program, within 14 days post-intervention? Can an integrated participant recruitment and retention strategy recruit approximately 28 eligible participants within 4 weeks and maintain less than 50% attrition rates in the context of a randomized trial on point-of-care OEND and simulated overdose resuscitation performance in family practice, emergency department, and addictions settings?

NCT ID: NCT04740073 Suspended - Clinical trials for Total Knee Arthroplasty

How Muscle and Tendon Properties Contribute to Functional Change Prior to and Following Knee Replacement

Start date: February 2021
Phase:
Study type: Observational

It is unknown how progressive physiological change in muscle and tendon contributes to loss of functional ability in patients undergoing total knee replacement between referral to surgery, and during post-surgery recovery. This study will use ultrasound and neurophysiological measures to evaluate progressive alterations of tissue to understand functional decline in men and women prior to and following knee replacement surgery. A group of healthy controls not undergoing knee replacement will also be studied to contrast changes in the patient group to normal changes over time. It is hypothesized that from the point of referral to surgery, patients will exhibit reductions in muscle and tendon size (atrophy) and reflex excitability that will be greater in the surgical compared with non-surgical leg, and these changes will precede observable losses in functional measures and strength. Secondly, it is hypothesized that following total knee replacement, muscle and tendon size, reflex activity, strength and functional measures will increase to a level below the pre-surgery values.

NCT ID: NCT04739761 Completed - Breast Cancer Clinical Trials

A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer

DESTINY-B12
Start date: June 22, 2021
Phase: Phase 3
Study type: Interventional

This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).

NCT ID: NCT04739059 Active, not recruiting - Clinical trials for Hereditary Angioedema

Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks

Start date: March 29, 2021
Phase: Phase 3
Study type: Interventional

This phase 3b study will evaluate long-term safety and efficacy of CSL312 (also known as garadacimab) when administered subcutaneously (SC)

NCT ID: NCT04738487 Recruiting - Lung Neoplasms Clinical Trials

Coformulation of Pembrolizumab/Vibostolimab (MK-7684A) Versus Pembrolizumab (MK-3475) Monotherapy for Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Metastatic Non-Small Cell Lung Cancer (MK-7684A-003, KEYVIBE-003)

Start date: April 7, 2021
Phase: Phase 3
Study type: Interventional

The primary hypotheses are that coformulated pembrolizumab/vibostolimab is superior to pembrolizumab alone with respect to (1) overall survival (OS) in participants with programmed cell death 1 ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%, TPS ≥1% and TPS 1% to 49%; and (2) progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR), in participants with PD-L1 TPS ≥1% and TPS ≥50%.

NCT ID: NCT04738136 Suspended - Covid19 Clinical Trials

Safety, Tolerability and Efficacy Of S-1226 in Moderate Severity Covid-19 Bronchiolitis/Pneumonia

Start date: September 15, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized, open-label, controlled, Phase II proof of concept study to evaluate the safety, tolerability and efficacy of S-1226 in which hospitalized subjects (n≤30) with moderate severity COVID-19 Bronchiolitis/Pneumonia will be enrolled. The safety and tolerability of S-1226 composed of PFOB with ascending doses of carbon dioxide (4%, 8%, and 12% CO2) administered twice daily will be assessed subjects in hospitalized subjects with moderate severity COVID-19 Bronchiolitis/Pneumonia.

NCT ID: NCT04738071 Active, not recruiting - Stroke Clinical Trials

International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry

IMPROVE
Start date: November 13, 2019
Phase:
Study type: Observational [Patient Registry]

Patent foramen ovale (PFO) is a prevalent cause of ischemic stroke and transient ischemic attack (TIA) in young patients. Its role as a cause of cerebrovascular events in the older population is more controversial because of other competing causes are more frequent in the elderly. Recent randomized controlled trials (RCTs) have shown that PFO closure is associated with a 59% relative risk reduction in the risk of recurrent ischemic stroke. As such, the number of PFO closure procedures are expected to increase substantially in the upcoming years. Real world data (RWD) informing on the medical management, the risk of stroke recurrence, incident atrial fibrillation, and other outcomes in stroke patients with PFO, with and without PFO closure, will become crucial for understanding how results from RCTs are translated into clinical practice globally. The IMPROVE (International Multicenter Patent foRamen OVale & strokE) Registry is an observational, multicenter, international registry of men and women with an ischemic stroke or TIA. The aim is to enroll 8,800 patient-years at ≥50 sites in ≥20 countries. The IMPROVE Registry will provide important information about the management and related outcomes of patients with ischemic stroke or TIA and PFO throughout different regions of the world and across a wide spectrum of healthcare systems.

NCT ID: NCT04737577 Recruiting - High Grade Glioma Clinical Trials

Glioma Supra Marginal Incision Trial

G-SUMIT
Start date: February 5, 2021
Phase: N/A
Study type: Interventional

G-SUMIT is a pilot, phase II,randomized controlled trial to evaluate the feasibility of performing a large-scale trial in patients undergoing surgery for first-time diagnosis of high grade glioma (HGG) in a surgically favorable anatomical location to answer the following: Does extending the margin of resection 1 cm beyond visible enhanced volume on MRI result in (a) an increase in overall survival? (b) result in a similar rate of "clinically-significant" neurological worsening during 30 days post surgery and quality of life at 6 and 12 months?

NCT ID: NCT04737538 Completed - Gingivitis Clinical Trials

A Proof-of-principle Clinical Study Investigating the Efficacy of an Experimental Dentifrice Containing Sodium Bicarbonate and Sodium Hyaluronate on Gingivitis

Start date: February 10, 2021
Phase: Phase 2
Study type: Interventional

The aim of this study is to develop a daily use toothpaste containing sodium bicarbonate, sodium hyaluronate and sodium fluoride with the intention of providing improved/ fast gum healing. This Proof-of-Principle study will investigate the efficacy of an experimental dentifrice compared to a regular fluoride dentifrice, and also whether this provides any additional benefit in reducing gingival inflammation/ bleeding compared with a 67% w/w sodium bicarbonate/ 0.221% w/w sodium fluoride containing toothpaste.

NCT ID: NCT04737278 Completed - Neuralgia Clinical Trials

Safety and Efficacy of Cunermuspir on Energy, Strength, and Fatigue in Patients With Nerve or Muscle Pain

Start date: January 28, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Male and female participants were selected based on chronic neuromuscular pain. Patients were instructed to take two doses of the placebo or cuprous nicotinic acid chelate Cunermusmir twice a day for 28 days. Hypothesis: Cunermuspir would improve quality of life as determined by several questionnaires.