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NCT ID: NCT04185883 Recruiting - Clinical trials for Advanced Solid Tumors

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Start date: December 17, 2019
Phase: Phase 1
Study type: Interventional

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

NCT ID: NCT04185753 Recruiting - Clinical trials for Cardiovascular Risk Factor

Chronotropic Incompetence During Exercise Testing in Obese Adolescents

Start date: November 29, 2019
Phase:
Study type: Observational

In adolescents with obesity cardiopulmonary exercise testing (CPET) has become an important clinical examination providing valuable information with regard to the integrative exercise responses, including the pulmonary, cardiovascular and muscular systems. During CPET, mechanical constraints in ventilation, an elevated risk for hypoxia and chronotropic incompetence (CI) (defined as the inability of the heart to increase its rate with increased activity), or compromised cardiac function (e.g. lowered heart rate (HR) recovery, chronotropic index and stroke volume) are often observed in obese adults. Moreover, several studies regarding exercise capacity and cardiopulmonary responses to maximal endurance exercise testing have been performed in obese adolescents. Despite these previous investigations in obese adolescents it remains controversial whether cardiopulmonary disturbances can be observed consistently during CPET. However, a number of studies have reported a suboptimal response to exercise, in particular a reduced peak heart rate (HRpeak) and peak cycling power output (Wpeak). Adult obesity modifies cardiac behavior, including resting HR and CI, which has a marked effect on exercise capacity. Therefore, chronotropic variables are the most important factors that affect exercise performance. It has been shown that both peak and resting HR account for over forty percent of variability of exercise capacity. Interestingly, resting HR and HR response to exercise, including a blunted HR increase, low chronotropic index and HR recovery, are important predictors of all-cause mortality and cardiovascular death, at least in adults. These changes in HR during and recovery from CPET are mediated by the balance between sympathetic and vagal activity of the autonomic nervous system. Adverse cardiovascular outcomes associated with the metabolic syndrome may be mediated by autonomic dysfunction, whereby obesity is characterized by sympathetic predominance and a decrease in vagal activity in the basal state, where reduced sympathetic responsiveness has been observed during exercise. Therefore, these multiple exercise risk markers could provide valuable clinical information regarding cardiometabolic health. Nonetheless HR behavior during CPET has not been described in obese adolescents. The goal of this study is to examine the HR behavior of obese adolescents during CPET to clarify whether this population suffer from CI.

NCT ID: NCT04180605 Recruiting - Atrial Fibrillation Clinical Trials

Computational Simulation to Plan for Percutaneous Left Atrial Appendage Closure

Start date: January 6, 2020
Phase: N/A
Study type: Interventional

To ensure a successful percutaneous left atrial appendage (LAA) closure, it is important to select the correct size of the closure device used for each patient. To define and measure the size of the LAA, 2D transesophageal echocardiography (TEE) has been typically used. An increasing number of hospitals recently switched to measure the size of the LAA using a cardiac computed tomography (CT) scan. Although this CT scan helps to better define and measure the LAA, it is still difficult to determine the exact anticipated 'landing zone' or 'position' of the closure device. A novel strategy of preprocedural planning includes the use of preoperative computer simulations based on CT imaging (Feops HEARTguideTM), where the device is deployed with a computer simulation into the patient-specific LAA anatomy to provide the operator both optimal and suboptimal scenario's showing different sizes and positions of the closure device. The aim of this study is to assess whether use of FEops HEARTguide computer simulations based on cardiac CT-imaging can contribute to a better preprocedural planning and improved procedural outcomes of percutaneous LAA closure procedures with an Amplatzer Amulet device. The PREDICT-LAA trial will investigate the possible positive effect of a computer simulation using a CT scan of the LAA performed prior to the procedure. The hypothesis is that by using this new computer simulation, better planning of the intervention can be obtained.

NCT ID: NCT04180371 Recruiting - Ovarian Cancer Clinical Trials

Study BT5528-100 in Patients With Advanced Solid Tumors Associated With EphA2 Expression

Start date: November 7, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This clinical trial is evaluating a drug called BT5528 alone and in combination with nivolumab in participants with advanced solid tumors historically known for expression of EphA2. The main goals of this study are to: - Find the recommended dose(s) of BT5528 that can be given safely to participants alone and in combination with nivolumab - Learn more about the side effects of BT5528 - Learn about how effective BT5528 is for the treatment of ovarian cancer, urothelial/bladder cancer, lung cancer (NSCLC), triple-negative breast cancer, head and neck cancer (HNSCC), and gastric/upper gastrointestinal cancer. - Learn more about BT5528 therapy alone and in combination with nivolumab.

NCT ID: NCT04178213 Recruiting - Aortic Stenosis Clinical Trials

First in Human Feasibility Study With ADAPT 3D - ALR for Aortic Leaflet Repair

Start date: March 26, 2020
Phase: N/A
Study type: Interventional

This study will evaluate the safety and performance of the ADAPT 3D - ALR in adult patients requiring replacement of aortic valve. 15 patients in one site in Belgium will all be treated with ADAPT 3D - ALR.

NCT ID: NCT04176198 Recruiting - Myelofibrosis Clinical Trials

A Study of Oral TP-3654 in Patients With Myelofibrosis

Start date: December 16, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of TP-3654 in patients with intermediate or high-risk primary or secondary MF.

NCT ID: NCT04173377 Recruiting - Orthopedic Disorder Clinical Trials

Elbow Outcomes Clinical Study (WELBOW)

WELBOW
Start date: June 8, 2020
Phase:
Study type: Observational

WELBOW study is an international, ambispective and prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF).

NCT ID: NCT04173273 Recruiting - Crohn's Disease Clinical Trials

A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

CULTIVATE
Start date: January 6, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.

NCT ID: NCT04171856 Recruiting - Stroke, Acute Clinical Trials

Exploring Motor Learning in Acute Stroke Through Robotics

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The acute phase of stroke is characterized by an enhancement of neural plasticity which supports rapid motor recovery. It is unclear whether acute stroke patients can acquire new motor skills with their affected upper limb. The aims of this research program are: 1. To test the capacity of acute stroke patients (< 21 days) to learn and retain a complex unimanual motor skill. 2. To explore whether acute stroke to different brain regions (quantified with brain MRI) induces specific deficits in motor skill learning. 3. To compare acute stroke patients with healthy individuals and with chronic stroke patients.

NCT ID: NCT04168528 Recruiting - Breast Cancer Clinical Trials

Phase I/IIa Study of 68GaNOTA-Anti-MMR-VHH2 for PET/CT

Start date: November 5, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Phase I study to evaluate the human safety and tolerability, biodistribution and dosimetry of 68GaNOTA-Anti-MMR-VHH2 Phase IIa study to evaluate tumour uptake of 68Ga-NOTA-anti-MMR-VHH2 in patients with breast cancer or melanoma. To correlate uptake of 68Ga-NOTA-anti-MMR-VHH2 in cancer lesions to immunohistological MMR staining after resection or biopsy of the same lesion.