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NCT ID: NCT05221840 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

PACIFIC-9
Start date: February 7, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.

NCT ID: NCT05221554 Recruiting - Clinical trials for Total Hip Arthroplasty

Pre-Op THA Modelling

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Replacing diseased hip joints with prosthetic implants in a procedure called total hip arthroplasty (THA) is associated with high rates of patient satisfaction, pain relief, and functional improvement when the implant is appropriately placed. Incorrect implant size or placement may lead to a breadth of negative outcomes, which could result in the need for implant revision. It is difficult to assess the precise orientation of patient hips on the operating table, with one study revealing that only 26% of acetabular cups placed without technological assistance are correctly positioned. Using computer navigation as a guide to achieve optimal implant alignment may improve successful placement rates. The additional incorporation of real-time modeling software may further help realize higher rates of successful implant placement. This study, therefore, aims to investigate a computer navigation system coupled with real-time modeling software to establish the benefit of such technology in the operating room, and further improve positive patient outcomes following THA. We hypothesize that including technological assistance in THAs will yield better patient outcomes compared to surgeries performed freehand.

NCT ID: NCT05221281 Active, not recruiting - Ulcerative Colitis Clinical Trials

Implementing a Multimodal RCT Intervention to Improve the Transition of Patients With Crohn's Disease From Pediatric to Adult Care

Start date: February 25, 2022
Phase: N/A
Study type: Interventional

Background: Transition in care is defined as the "purposeful and planned movement of adolescents and young adults with a chronic medical condition from pediatric to adult-oriented healthcare systems/care providers." Currently, there is no Level 1 evidence of an intervention to improve the care of transitioning adolescents and young adults (AYAs) with inflammatory bowel disease (IBD). The development of a transition program using a biopsychosocial approach will improve the standards for healthcare delivery to transitioning IBD patients. This is a protocol for a structured randomized controlled trial (RCT) to assess the efficacy and impact of a multimodal intervention focused on improving patient function, transition readiness and outcomes among AYA patients with IBD being cared for at pediatric centers in Canada. Methods: This multi-center RCT is a type 1 hybrid effectiveness-implementation trial to evaluate effectiveness of the intervention and how it can be implemented more widely after the trial. We will include patients aged 16.0 to 17.5 years. The intervention program consists of 4 core components: 1) individualized assessment, 2) transition navigator, 3) virtual patient skills-building with a focus on building resilience, self-management and self-efficacy, and 4) a virtual structured education program. The control group will undergo standard-of-care defined by each participating center. The primary outcome will be the IBD Disability Index, a validated measure to assess patient functioning. Secondary outcomes include transition readiness, anxiety and depression scales, and health service utilization rates. Additionally, we will identify the effectiveness of an evidence-based implementation approach and related barriers and facilitators for the intervention program. Discussion: The type 1 hybrid effectiveness-implementation design will allow us to develop a feasible, sustainable, and acceptable final intervention model. The intervention will consist of modules that can be accessed in an online, virtual platform. The implementation will not depend on individual hospital resources, allowing centralization of interventions and funding. The authors anticipate that the main study limitation will relate to study subjects not completely adhering to every component of the intervention, which will be evaluated and addressed using the implementation science approach.

NCT ID: NCT05220774 Completed - ERCP Clinical Trials

Conscious Sedation Versus Anesthesia for ERCP

Start date: October 1, 2018
Phase:
Study type: Observational

Studies directly comparing EDCS with AAS during ERCP are scarce, varying widely in their designs and reaching conflicting conclusions regarding safety and effectiveness. The investigators will assess, via a multi-center prospective study, the success, adverse event rates, and patient tolerability of ERCP when performed under AAS versus EDCS.

NCT ID: NCT05220761 Enrolling by invitation - Delirium Clinical Trials

Family Assessment of Pediatric Delirium

FAM-CAPD
Start date: August 9, 2021
Phase:
Study type: Observational

In this study the investigators will assess the validity, reliability and acceptability of utilizing family members to complete a delirium screen using the Cornell Assessment of Pediatric Delirium (CAPD).

NCT ID: NCT05220501 Recruiting - Prostate Cancer Clinical Trials

Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

OPTIMUM
Start date: January 21, 2021
Phase: N/A
Study type: Interventional

OPTIMUM is a study designed to compare the ability of ultra-high resolution transrectal micro-ultrasound (microUS) and multiparametric MRI (mpMRI)/US fusion to guide prostate biopsy.

NCT ID: NCT05220098 Recruiting - Clinical trials for Unresectable Locally Advanced or Metastatic Cancer

First-in-Human Study of TAK-280 in Participants With Unresectable Locally Advanced or Metastatic Cancer

Start date: April 22, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The main aim of this study is to find out the safety, tolerability, and effect of TAK- 280 in participants with unresectable, locally advanced or metastatic cancer who have experienced treatment failure or are intolerant to standard therapies. Participants will be treated with TAK-280 for up to 14 treatment cycles. Each treatment cycle will be 28 days. After the last dose of study drug, participants will be followed up for survival every 12 weeks for a total of 48 weeks.

NCT ID: NCT05219864 Withdrawn - Hand Eczema Clinical Trials

Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1

TRuE-CHE1
Start date: January 31, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).

NCT ID: NCT05219123 Recruiting - ERCP Clinical Trials

Guidewire Management in ERCP

Start date: December 20, 2021
Phase:
Study type: Observational

Intra-procedural guidewire management is a parameter whose impact remains incompletely understood in terms of its association with post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). Inadvertent guidewire cannulation of the pancreatic duct (PD) when attempting common bile duct (CBD) cannulation is recognized as a risk factor for PEP. However, to date, no studies have assessed whether a single PD wire cannulation is associated with a higher PEP risk compared to no PD cannulations. Similarly, the relationship between each additional PD cannulation and the incremental magnitude of PEP risk remains unclear. In this study, the investigators will aim to assess whether a single inadvertent PD cannulation (versus no PD cannulation) is associated with an increased risk of PEP (the primary outcome).

NCT ID: NCT05219110 Recruiting - Clinical trials for Hemolytic-Uremic Syndrome

Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection

HIKO-STEC
Start date: September 29, 2022
Phase: Phase 3
Study type: Interventional

The objective of this study is to determine if early high volume intravenous fluid administration (hyperhydration) may be effective in mitigating or preventing complications of shiga toxin-producing E. coli (STEC) infection in children and adolescents when compared with traditional approaches (conservative fluid management).