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NCT ID: NCT04195568 Active, not recruiting - Clinical trials for Aneurysm, Intracranial

Evaluation of Safety and Effectiveness of Stryker Surpass Evolve™ Flow Diverter System

EVOLVE
Start date: July 7, 2020
Phase: N/A
Study type: Interventional

The primary objective of this study is to evaluate the safety and effectiveness of the Surpass™ Evolve Flow Diverter System in the treatment of unruptured, wide-neck intracranial aneurysms measuring ≤ 12 mm and located on the ICA or its branches

NCT ID: NCT04195503 Enrolling by invitation - Clinical trials for Cholangiocarcinoma, Intrahepatic

Liver Transplant for Stable, Advanced Intrahepatic Cholangiocarcinoma

Start date: December 10, 2019
Phase: N/A
Study type: Interventional

Diagnosis of intrahepatic cholangiocarcinoma (iCCA) is an increasingly common form of primary liver cancer, but patients with this diagnosis are not currently eligible for LT. This study proposes to offer LT as an option to patients with advanced, unresectable iCCA who demonstrate at least 6 months of disease stability /regression while receiving standard chemotherapy. Patients will be referred and screened for study participation if they have achieved 6 months of disease stability. They will be worked up for transplant and if eligible, will be listed. Disease must remain controlled while awaiting transplantation. After transplantation, patients will be followed for disease recurrence and overall survival, while receiving standard post-transplantation followup.

NCT ID: NCT04195399 Active, not recruiting - Clinical trials for Desmoid Fibromatosis

A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery

Start date: October 7, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial studies the side effects and how well nirogacestat works in treating patients less than 18 years of age with desmoid tumors that has grown after at least one form of treatment by mouth or in the vein that cannot be removed by surgery. Nirogacestat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT04195256 Recruiting - Fracture Clinical Trials

Intranasal Dexmedetomidine Plus Ketamine for Procedural Sedation

Ketodex
Start date: March 11, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Orthopedic injuries comprise more than 10% of ED visits in children and 25 to 50% of children will sustain a fracture before age 16 years. Distal radius fractures account for 20-32% of fractures in children, making them the most common fracture type. Between 20 and 40% of extremity fractures in children require a closed reduction, often necessitating procedural sedation and analgesia (PSA). Intravenous (IV) ketamine is the most commonly used sedative agent used to perform a closed reduction. However, children rate IV insertion as the most painful hospital experience, second only to the injury itself. IV insertion can be more technically difficult in children because of smaller veins and lack of cooperation, often leading to multiple IV attempts. A combination of intranasal (IN) dexmedetomidine plus ketamine (IN Ketodex) may provide effective sedation for children undergoing a closed reduction without the distress and pain related to IV insertion. A less painful experience has been found to correlate with child satisfaction which may reduce caregiver anxiety and improve the therapeutic relationship with the health care team. This study is a multi-centre, two-arm, randomized, blinded, controlled, non-inferiority trial designed to test the hypothesis that IN Ketodex is non-inferior to intravenous (IV) ketamine with respect to depth of sedation as measured using the Pediatrics Sedation State Scale (PSSS).

NCT ID: NCT04195113 Completed - Atrial Fibrillation Clinical Trials

Perioperative Anticoagulant Use for Surgery Evaluation Emergency Registry

PAUSE-ER
Start date: August 7, 2019
Phase:
Study type: Observational [Patient Registry]

Among patients who are receiving long-term anticoagulant therapy, whether with a direct oral anticoagulant (DOAC) or vitamin K antagonist (VKA), approximately 3-5% who require treatment interruption for a surgery will do so in an urgent/emergency surgery setting. Additionally, there is considerable morbidity and mortality associated with DOAC/VKA management in an urgent/emergency surgery setting. Thus, this prospective registry study aims to identify and compare determinants for perioperative adverse events in DOAC-treated and VKA-treated patients who require an urgent/emergency surgery, and to identify which of these are modifiable. It also aims to describe and compare management of anticoagulant reversal (i.e., non-specific and specific reversal agents) and resource utilization (i.e., blood transfusion) in DOAC- and VKA-treated patients who need an urgent/emergency surgery.

NCT ID: NCT04194944 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study of Selpercatinib (LY3527723) in Participants With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

LIBRETTO-431
Start date: February 17, 2020
Phase: Phase 3
Study type: Interventional

The reason for this study is to see if the study drug selpercatinib compared to a standard treatment is effective and safe in participants with rearranged during transfection (RET) fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.

NCT ID: NCT04194502 Completed - Clinical trials for Congenital Heart Disease

Coronary Artery Assessement by TEE in Congenital Heart Disease

Start date: April 19, 2017
Phase: N/A
Study type: Interventional

This study aims to establish normal coronary artery pulse Doppler flow patterns and velocities using transoesophageal echocardiography (TEE) in patients with a variety of congenital heart disease. This will be accomplished by performing pre-operative and intra-operative TEEs on up to 250 patients undergoing surgery for congenital heart disease.

NCT ID: NCT04194450 Completed - Type 2 Diabetes Clinical Trials

Exogenous Ketones in Type 2 Diabetes

Start date: January 15, 2020
Phase: N/A
Study type: Interventional

Exogenous ketone supplements are proposed to have glucose-lowering potential, provide an alternative fuel for the brain and to enhance cognitive function. No studies have tested whether exogenous ketones can lower blood glucose in people with type 2 diabetes. In addition, the impact of exogenous ketones on brain blood flow, cognitive function or brain-derived neurotrophic factor in humans is unknown. The purpose of this study is to determine if acutely ingesting exogenous ketones, in the form of a ketone monoester drink, can lower glucose and improve measures of brain/cognitive function in humans with type 2 diabetes. Participants will consume a ketone monoester drink or placebo with blood samples, brain blood flow, and cognitive function assessed over 180 minutes. The researchers will also test how the ketone monoester drink impacts appetite and measures of inflammation.

NCT ID: NCT04194346 Recruiting - Clinical trials for Mechanical Ventilation Complication

Determination of Normal Values of Regional Pulmonary Strain Using a New Ultrasonographic Tool in Healthy Volunteers

Strain
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

Mechanical ventilation is frequently used in the operating room and the intensive care settings. Although essential in many cases, mechanical ventilation can be responsible for ventilator-induced lung injury (VILI). The relationship between mechanical ventilation and VILI has been clearly demonstrated in animals and is highly suspected in humans. The putative mechanism responsible for VILI is excessive pulmonary strain or overdistension. Frequently observed in mechanically ventilated patients, the presence of a severe pre-existing pulmonary disease can increase the risk of overdistension. The development of a tool allowing early detection of pulmonary overdistension would represent a great asset in the prevention of VILI by allowing safer adjustments of mechanical ventilation parameters. Ultrasonographic imaging is a non-radiant, non-invasive technique already available in the intensive care setting. Already used for cardiac strain measurements, ultrasonography is a promising avenue to assess pulmonary strain.This study will aim to establish normal pleural strain values using ultrasonography in healthy volunteers. Purpose: The primary objective is to calculate 95% confidence intervals in pleural strain for a set of 8 inspired volumes at 15 predetermined lung areas in healthy volunteers. The secondary objectives of the study are: - to modelize the relation between pleural strain and inspired volume - to modelize the relation between pleural strain and global pulmonary volumetric strain - to modelize the relation between pleural strain and maximal echo intensity change - to compare the regional distribution pattern of pleural strain in healthy volunteers in dependent versus non-dependent areas. Hypothesis: Elastography using the Lagrangian speckle model estimator based on optical flow allows the determination of normal mean values and 95% confidence intervals of pleural strain (average Von Mises coefficient) in 15 predetermined lung areas for a set of 8 inspired volumes in healthy volunteers.

NCT ID: NCT04194138 Recruiting - Scoliosis Clinical Trials

Complex Adult Deformity Surgery (CADS)

CADS
Start date: July 30, 2018
Phase:
Study type: Observational [Patient Registry]

Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and clinical outcomes, surgical and postoperative complications, risk factors for and revision surgery rates, and the role of standard work to improve patient outcomes and reduce surgical and postoperative complications.