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NCT ID: NCT05494606 Recruiting - Ulcerative Colitis Clinical Trials

An Observational Study to Assess Change in Disease Activity and Adverse Events of Upadacitinib in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Real-World Practice

PROFUNDUS
Start date: August 15, 2022
Phase:
Study type: Observational

Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective upadacitinib is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed. Upadacitinib is a drug approved for the treatment of Ulcerative colitis (UC). All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 1000 adult participants will be enrolled worldwide. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 3 years. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

NCT ID: NCT05494034 Recruiting - Stroke Clinical Trials

Yield of Implantable Cardiac Monitoring Device in Patients With Acute Ischemic Stroke.

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

In this prospective cohort study, the investigators aim to investigate the incidence of ICM-detected AF in unselected ischemic stroke patients and its association with anticoagulation initiation and stroke recurrence.

NCT ID: NCT05493761 Recruiting - Clinical trials for Osteoporosis, Postmenopausal

Effect of Anti-osteoporotic Medications on Nonalcoholic Fatty Liver Disease

OsteoNAFLD
Start date: December 23, 2022
Phase: Phase 4
Study type: Interventional

Nonalcoholic fatty liver disease (NAFLD) is a chronic, metabolic liver disease that is closely related to obesity, type 2 diabetes mellitus (T2DM) and metabolic syndrome (MetS) in a bidirectional mode. NAFLD affects approximately 25% of the worldwide population. NAFLD refers to a phenotypic spectrum, including steatosis, inflammation and fibrosis, which can lead to cirrhosis and hepatocellular carcinoma in a minority of patients. However, despite its high prevalence, morbidity and mortality, as well as the extensive research in the field, there is not to-date a licensed medication specifically for NAFLD. Emerging evidence supports a potential association between NAFLD and osteoporosis; the prevalence of osteoporosis is probably higher in patients with NAFLD and, vise versa, the prevalence of NAFLD may be higher in patients with osteoporosis. In this context, it has been proposed that certain medications for osteoporosis may also prove to be beneficial to NAFLD. Denosumab, a human monoclonal IgG2 antibody against the receptor activator of nuclear factor kappa-B (NF-κB) ligand (RANKL), is currently an established treatment for osteoporosis and other metabolic bone diseases. The axis RANKL-receptor activator of nuclear factor NF-κB (RANK)-osteoprotegerin (OPG) has been demonstrated as a key regulator of bone metabolism and, when dysregulated, it contributes to the pathogenesis of osteoporosis and other metabolic bone diseases. Interestingly, experimental studies have shown that circulating and hepatic RANKL may be upregulated in mice with diet-induced NAFLD, rendering RANKL a potential contributor to the pathogenesis of NAFLD, and ideally, a promising pharmacological target. On the other hand, bisphosphonates, another established, first-line treatment for osteoporosis, are expected to have no significant effect on hepatic metabolism in patients with NAFLD due to their pharmacokinetics and mechanism of action. This is a prospective non-randomized study which aims to investigate the comparative effect of denosumab versus bisphosphonates on hepatic steatosis and fibrosis in women with postmenopausal osteoporosis and concomitant NAFLD.

NCT ID: NCT05492344 Recruiting - Clinical trials for Mechanical Ventilation

Personalized Mechanical Ventilation Guided by UltraSound in Patients With Acute Respiratory Distress Syndrome

Start date: August 9, 2022
Phase: N/A
Study type: Interventional

Rationale Acute respiratory distress syndrome (ARDS) is a frequent cause of hypoxemic respiratory failure with a mortality rate of approximately 30%. The identification of ARDS phenotypes, based on focal or non-focal lung morphology, can be helpful to better target mechanical ventilation strategies of individual patients. Lung ultrasound (LUS) is a non-invasive tool that can accurately distinguish 'focal' from 'non-focal' lung morphology. The investigators hypothesize that LUS-guided personalized mechanical ventilation in ARDS patients will lead to a reduction in 90-day mortality compared to conventional mechanical ventilation.

NCT ID: NCT05490238 Recruiting - Clinical trials for Vascular Access Site Occlusion

DIStal Versus COnventional Radial Access for COMPLEX Large-bore Percutaneous Coronary Intervention

DISCO COMPLEX
Start date: August 31, 2023
Phase: N/A
Study type: Interventional

The use of the distal radial artery has recently emerged as a promising alternative access route to further reduce the risk of radial artery occlusion (RAO) and has been endorsed by recent International Consensus documents. The feasibility of a distal radial access (DRA) for coronary angiography and/or PCI has been demonstrated in several observational clinical registries and small-sized randomized clinical trials. In the recent prospective, multicenter, open label, randomized, controlled DIStal vs Conventional RADIAL access (DISCO RADIAL) trial, DRA was associated with low and similar rates of RAO at discharge when compared to conventional TRA among patients undergoing coronary angiography and/or PCI. There is however limited evidence on the feasibility and safety of 7F DRA for PCI. In a prospective, multicenter, observational study including 41 patients undergoing CTO PCI using a left DRA with a 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan), technical success was achieved in 90.3% of patients and procedural success was achieved in 78.1% of patients. No post-procedural DRA RAO were detected by clinical assessment and Doppler ultrasound examination, and no radial artery occlusions at the site of the forearm were found. Doppler ultrasound imaging of the DRA at one month was available in 67.6% of patients, with only one case (4.3%) of DRA RAO. This proof-of-concept study demonstrates that DRA using a 7F GLIDESHEATH SLENDER® (Terumo Corp., Tokyo, Japan) for CTO PCI is feasible and associated with a high procedural success rate and low vascular access-site complication rates. No randomized clinical trial to date has however compared the feasibility and safety of a 7F DRA versus 7F TRA for PCI of complex coronary lesions, such as chronic total occlusions (CTO), left main coronary artery disease, heavily calcified lesions, complex bifurcations, or other complex coronary lesions for whom the operator anticipates that a 7F guiding catheter is indicated.

NCT ID: NCT05487612 Recruiting - Clinical trials for Coronary Artery Disease

MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)

MiECS
Start date: May 26, 2022
Phase: N/A
Study type: Interventional

MiECS is one of the largest multicentre randomised controlled trials on extracorporeal circulation conducted under the auspices of Minimal Invasive Extracorporeal Technologies International Society (MiECTiS). It is designed to ultimately address the emerging effectiveness of MiECC systems in the light of modern perfusion practice worldwide. The primary hypothesis is that MiECC, as compared to conventional CPB (cCPB), reduces the proportion of patients experiencing serious perfusion-related postoperative morbidity after cardiac surgery. The study will be led by the Clinical Research Unit of the Special Unit for Biomedical Research and Education (SUBRE), Aristotle University of Thessaloniki School of Medicine in Greece (AUSoM) with Chief Investigator Professor Kyriakos Anastasiadis, who is a key-opinion-leader in the field of MiECC, founder and Executive Board of MiECTiS.

NCT ID: NCT05481710 Recruiting - Clinical trials for Chronic Shoulder Pain

Nociplastic Pain in Patients With Chronic Shoulder Pain

Start date: July 18, 2022
Phase:
Study type: Observational

The aim of this study was to investigate predictors of nociplastic shoulder pain. Factors of psychological distress, functionality, fitness, quality of life, quality of sleep, functioning of the parasympathetic system, and lifestyle will be examined. Patients with nociplastic pain will be identified using the classification system proposed by the IASP.

NCT ID: NCT05480865 Recruiting - Clinical trials for Non Small Cell Lung Cancer

SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation

Argonaut
Start date: July 6, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase 1 study of BBP-398, a SHP2 inhibitor, in combination with sotorasib, a KRAS-G12C inhibitor (KRAS-G12Ci), in patients with a KRAS-G12C mutation. The study involves 2 parts: Phase 1a Dose Escalation and Phase 1b Dose Expansion/Optimization.

NCT ID: NCT05479188 Recruiting - Clinical trials for Coronary Artery Disease

Comparative Analysis of the Microcirculation During Cardiac Surgery With Minimal Invasive Versus Conventional Extracorporeal Circulation

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

The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery with minimal invasive versus conventional extracorporeal circulation. Positive clinical results evidenced with goal-directed perfusion and cerebral oximetry monitoring could be attributed to preserved microcirculation at tissue level.

NCT ID: NCT05473299 Recruiting - Clinical trials for End-stage Renal Disease

Xeltis Hemodialysis Access Graft: aXess Pivotal Study

Start date: November 4, 2022
Phase: N/A
Study type: Interventional

A prospective, single arm, non-randomized pivotal study to evaluate the safety and performance of the Xeltis hemodialysis access graft in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.