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NCT ID: NCT05379634 Recruiting - Myositis Clinical Trials

A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

SPIREA
Start date: July 5, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).

NCT ID: NCT05378594 Recruiting - Allergic Rhinitis Clinical Trials

HDM and Silver Birch NAC Standardisation

Start date: September 22, 2022
Phase: N/A
Study type: Interventional

This study aims to establish dose-responses to nasal allergen challenge using silver birch pollen and house dust mite allergen extracts in participants with allergic rhinitis, sensitised to either or both of these allergens. The allergen extracts used will be Itulazax tablets (silver birch pollen allergen sublingual tablets, ALK-Abello, Denmark) and Acarizax tablets (house dust mite allergen sublingual tablets, ALK-Abello, Denmark). The results will allow identification of the dose of each allergen typically producing a moderate severity response, which could then be used in future, interventional and investigational studies. A control group - healthy individuals with no allergic rhinitis - will be recruited to demonstrate the absence of an irritant/non-allergic effect of the nasal allergen challenge procedure.

NCT ID: NCT05378347 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

ADVANCE
Start date: January 5, 2023
Phase: N/A
Study type: Interventional

The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.

NCT ID: NCT05376891 Recruiting - Cancer Clinical Trials

Met Non Small Cell Cancer Registry (MOMENT)

Start date: October 4, 2022
Phase:
Study type: Observational

The purpose of this multi-national disease registry is to collect prospectively (with longitudinal follow-up) high-quality, standardized, and contemporaneous data to capture changes in the non-small cell lung cancer (NSCLC) treatment landscape and outcomes over time. The registry will capture data on participants; demographic, clinical characteristics (including biomarker data), treatment patterns, and effectiveness and safety outcomes for advanced NSCLC with mesenchymal-epithelial transition exon 14 (METex14) participants treated with systemic therapy.

NCT ID: NCT05376514 Recruiting - Blood Pressure Clinical Trials

Central Blood Pressure and Variability Evaluation

CAVE-ON
Start date: June 7, 2022
Phase:
Study type: Observational [Patient Registry]

Background: A sub-study of the AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK) trial indicated a statistically significant association between central blood pressure (BP) variability and abdominal aortic aneurysm (AAA) growth. The role of anti-hypertensive adherence has not been explored in the context of AAA growth. Objective: To confirm whether higher central BP variability is associated with higher AAA growth rates and to examine the effect of medication adherence on AAA growth rates in a prospective longitudinal cohort study. Methods: Up to 175 patients will be recruited over ten months from two sites with standardised quality control of AAA, BP and antihypertensive non-adherence measurement. Patients (>55 years), with AAAs ≥3cm in diameter (including AAA ≥5.5cm, not proceeding to surgery) will be recruited and undergo AAA ultrasound (US), BP (peripheral and central) and antihypertensive non-adherence measurements every four months (+/- one month) for 24 months. Ambulatory BP variability data will be collected. Data on medication adherence and beliefs around medications will be collected with validated questionnaires. Analysis: Primarily, the relationship between central diastolic BP visit-to-visit variability and AAA growth (estimated by multilevel modelling) based on US measurements and secondarily the relationship between central diastolic BP variability and time taken to reach the threshold for AAA repair (5.5 cm) or rupture.

NCT ID: NCT05376267 Recruiting - Clinical trials for Hypoxia-Ischemia, Brain

Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)

Start date: August 5, 2022
Phase: N/A
Study type: Interventional

This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome.

NCT ID: NCT05376228 Recruiting - Clinical trials for Inflammatory Bowel Diseases

A Systems Biology Approach for Identification of Host and Microbial Mechanisms and Druggable Targets for the Treatment of PSC-IBD

PSC-Vanc
Start date: February 1, 2022
Phase:
Study type: Observational

Primary sclerosing cholangitis (PSC) is the classical hepatobiliary manifestation of inflammatory bowel disease (IBD). Although rare, PSC is associated with significant and disproportionate unmet needs; with heightened risks of colorectal cancer and colectomy, and greater all-cause mortality rates compared to matched IBD patients. Unfortunately, no medical therapy has been proven to slow disease progression in PSC-IBD, and liver transplantation is the only lifesaving intervention for patients. The strong association between PSC and IBD has led to several pathogenic hypotheses, in which dysregulated mucosal immune responses are proposed to contribute. Of note, the investigators recently identified distinct mucosal transcriptomic profiles in PSC-IBD; with regards bile acid metabolism, bile acid signalling, and a central role of enteric dysbiosis. In parallel, pilot data from other groups have shown that treatment with oral vancomycin (a non-absorbable, gut-specific antibiotic) attenuates colonic inflammation and improves biochemical markers of cholestasis in PSC. However, there is no mechanistic data exploring the host-microbial alterations under vancomycin treatment in PSC-IBD, neither the impact of vancomycin on bile acid circulation. The investigators of this study hypothesize that oral vancomycin attenuates colonic mucosal inflammation in PSC-IBD, by restoring gut microbiota mediated bile acid homeostatic pathways. Through these means the study aims to identify druggable gut microbial and host molecular pathways associated with bile acid mediated colonic mucosal inflammation in PSC-IBD.

NCT ID: NCT05375591 Recruiting - Lung Cancer Clinical Trials

AI & Radiomics for Stratification of Lung Nodules After Radically Treated Cancer

AI-SONAR
Start date: October 13, 2021
Phase:
Study type: Observational

This study will assess the utility of radiomics and artificial intelligence approaches to new lung nodules in patients who have undergone radical treatment for a previous cancer.

NCT ID: NCT05374590 Recruiting - Clinical trials for Generalized Myasthenia Gravis

Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis

ADAPT Jr +
Start date: August 18, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this trial is to evaluate the long-term safety of efgartigimod IV and efgartigimod PH20 SC administered to participants with gMG in the antecedent studies, ARGX-113-2006 and ARGX-113-2207, respectively.

NCT ID: NCT05374512 Recruiting - Breast Cancer Clinical Trials

A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)

Start date: May 16, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.