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NCT ID: NCT05329142 Recruiting - Drug Abuse Clinical Trials

ASSIST: A Surveillance Study of Illicit Substance Toxicity

ASSIST
Start date: August 19, 2022
Phase:
Study type: Observational

There is a drug-related death crisis in Scotland. This study aims to collaborate with Public Health Scotland in order to assess the feasibility of introducing a surveillance system to the Emergency Department to highlight illicit drug-related attendances. This will utilise both clinical data and toxiclogical analysis of anonymised samples. The data will inform of prevalence, trend data and utcome of ED patients attending with acute illict drug toxicity.

NCT ID: NCT05328492 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Volume Mode Non-invasive Ventilation in Amyotrophic Lateral Sclerosis

Start date: March 15, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the efficacy of using intelligent volume assured pressure support (iVAPS-AE) versus spontaneous timed (ST) modes of non-invasive ventilation (NIV) in patients diagnosed with amyotrophic lateral sclerosis (ALS). The investigators believe that the use of iVAPS-AE mode NIV over a 90 day period will produce NIV compliance data and health-related quality of life (HRQOL) scores that are equivalent or no worse compared to ST mode NIV.

NCT ID: NCT05327530 Recruiting - Clinical trials for Locally Advanced or Metastatic Urothelial Carcinoma

A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

Start date: August 17, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.

NCT ID: NCT05327114 Recruiting - Clinical trials for Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Start date: September 23, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A.

NCT ID: NCT05326412 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD

AERIFY-3
Start date: May 19, 2022
Phase: Phase 2
Study type: Interventional

This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former and current smokers with COPD, aged 40 to 70 years. This study consists of participants who have been on a standard-of-care (SoC) mono (long-acting β2-agonist [LABA]) or long-acting muscarinic antagonist [LAMA]), double (inhaled corticosteroid [ICS] + LABA, LABA + LAMA or ICS + LAMA), or triple (ICS + LABA + LAMA) controller therapy for COPD for at least 3 months prior to Screening (Visit 1) with stable dose and regimen for controller therapy for ≥1 month prior to Screening (Visit 1) and during the screening period. Participants will stay on their established controller medications for COPD throughout the duration of the study, with the exception of systemic corticosteroids and/or antibiotics used for acute exacerbation of COPD (AECOPD). The total study duration for each part (Part A and Part B) is approximately 36 weeks: - 4-week screening period - 12-week treatment period - 20-week followup period

NCT ID: NCT05325866 Recruiting - Solid Tumors Clinical Trials

A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression

FORTITUDE-301
Start date: September 23, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.

NCT ID: NCT05324943 Recruiting - Clinical trials for Gaucher Disease, Type 1

A Gene Therapy Study in Patients With Gaucher Disease Type 1

GALILEO-1
Start date: April 15, 2022
Phase: Phase 1
Study type: Interventional

This study is a first-in-human, open-label, safety, tolerability, and efficacy study in adult patients with Gaucher disease Type 1. The aims are to investigate the safety/tolerability and efficacy of FLT201, and to investigate the relationship of FLT201 dose to augmentation of residual glucocerebrosidase (GCase) expression (activity and concentration), and its potential to improve the clinical phenotype by reduction and prevention of cellular accumulation of GCase substrate.

NCT ID: NCT05324111 Recruiting - Clinical trials for Cardiovascular Diseases

VaLidation of the Simple Adaptation of the Kardia 6L ECG Recorder to Obtain Chest leAd equivaLents: a Multi-centre International (LOCAL-ECG) Study; on Behalf of the Africa Heart Rhythm Association Investigators

LOCAL-ECG
Start date: August 4, 2021
Phase: N/A
Study type: Interventional

ECGs are routinely performed in cardiology. Recently handheld ECGs have shown promise in screening for heart rhythm disorders. These are quick to perform and do not require the preparation that is needed for 12 lead ECGs. The aim is to test whether a novel adaptation to a handheld ECG recorder, Kardia 6L, which has the potential to record a 6 lead ECG is able to screen for ECG abnormalities, thereby obviating the need for a full 12 lead ECG. This may allow for earlier diagnosis and treatment and has implications in the prevention of infection. The lead author recently published a pilot study showing the clinical utility of this technique and the aim of this study is to validate the method.

NCT ID: NCT05322395 Recruiting - Clinical trials for Acute Coronary Syndrome

Pragmatic Randomised Trial of the ESC 0/1 Versus 0/3 Hour Troponin Pathway

MACROS2
Start date: December 10, 2021
Phase: N/A
Study type: Interventional

The primary objective of this study is to assess the feasibility and impact of implementing the ESC 0-1 hour high sensitive troponin pathway in clinical practice and with specific reference to the 0-3 hour pathway currently in use. The principal outcome measure will be the safety of the 0-1 hour protocol (which is less established and has limited data on safety when implemented in clinical practice)

NCT ID: NCT05322200 Recruiting - Clinical trials for Coronary Artery Disease

The POST-ACS Study

Start date: August 31, 2022
Phase: Phase 4
Study type: Interventional

Individuals with T2DM have a two-fold excess risk of cardiovascular (CV) events compared with their non-diabetic counterparts. Although it is the primary cause of death in T2DM, there is no significant evidence that intensive glucose lowering reduces CV events. Multiple Cardiovascular Outcome Trials have suggested CV safety and benefit with the new class hypoglycemic agents - glucagon-like peptide 1 receptor agonists (GLP-RAs) in patients with DM and a high CV risk profile with a mechanism not directly dependent on their glucose-lowering effect. Varies theories regarding the mechanism of action of GLP-RAs on reducing CV events have been proposed, including reducing inflammation, protection of ischemia/reperfusion injury, and improvement in endothelial dysfunction but the effects of these new agents on in-vivo atherosclerotic plaque burden is currently unproven. The investigators hypothesize that compared with placebo, 1-year treatment with the oral GLP-RA "Semaglutide" will result in a regression of necrotic core within potentially vulnerable coronary plaques (identified using the novel method "Plaque Maps" analysis on CT Coronary Angiography) in patients with raised HbA1c (>5.7%) after acute coronary syndromes (ACS). Methods: One hundred forty patients admitted with ACS and have raised HbA1c >5.7% will be enrolled in the trial and randomized in a 1:1 blinded fashion to receive conventional therapy and initiation of Semaglutide or conventional therapy plus placebo. All patients will have a CT Coronary Angiography with Plaque Map analysis of atherosclerotic burden, plaque composition and presence of potentially vulnerable plaque morphology at baseline prior to therapy initiation and following 12 months of treatment. In addition, to help elucidate the potential mechanisms of any anti-atherosclerotic effects, patients will have a non-invasive assessment of vascular function assessed by aortic pulse wave velocity and comprehensive biomarker analysis of inflammation, atherogenesis and oxidative stress.