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NCT ID: NCT04170946 Recruiting - Lung Cancer Clinical Trials

Talazoparib and Thoracic RT for ES-SCLC

Start date: October 5, 2020
Phase: Phase 1
Study type: Interventional

This is a phase I, dose escalating study evaluating the safety of combining talazoparib and low dose consolidative thoracic radiotherapy for small cell lung cancer patients. This study will also determine the maximum tolerated dose (MTD) of talazoparib in combination with low dose thoracic radiotherapy. Patients will start on talazoparib on day 1 of study intervention, and will continue to orally take talazoparib until the last day of radiation therapy. Up to 24 patients will be enrolled to the study, where the first 3 patients will start with a starting dose level of talazoparib is 0.5 mg PO once daily. This will increase to 1mg daily with each new cohort.

NCT ID: NCT04170855 Recruiting - Clinical trials for Cardio-Renal Syndrome

Kidney Sodium Content in Cardiorenal Patients

Start date: October 20, 2020
Phase: N/A
Study type: Interventional

Diuretic therapy is the cornerstone of the management of fluid overload in heart failure. Resistance to diuretic therapy is the most common reason for treatment failure in patients affected by the combination of heart failure and kidney disease. Currently, there is no way of predicting whether heart failure patients will develop resistance to diuretic therapy and what dose of diuretic is necessary to overcome diuretic resistance. Answering these questions would allow doctors to be able to prescribe an accurate dose of diuretic therapy to prevent diuretic resistance and potential side effects of an excessive diuretic dose. With magnetic resonance imaging, it is possible to measure the kidney sodium (salt) content and observe the diuretic response in patients with heart failure and kidney disease. The investigators speculate that measuring kidney sodium content will allow to predict diuretic response in these patients. The aim of this study is to compare the kidney sodium content in patients with chronic cardiorenal syndrome with and without diuretic resistance. Secondly, in a sample of patients with diagnosed diuretic resistance,the aim will be to observe the changes in kidney sodium content induced by an additional dose of diuretic therapy and to observe whether these changes are associated with a response to diuretic therapy.

NCT ID: NCT04170777 Completed - Brain Metastases Clinical Trials

Perfexion Registration Using CBCT

Start date: September 1, 2020
Phase:
Study type: Observational

Measuring precision radiation delivery through cone-beam computed tomography (CBCT) and intra-fraction motion management (IFMM) incorporated on a GammaKnife unit via the Leksell Coordinate Frame (LCF) and relocatable mask system (RMS) immobilization devices.

NCT ID: NCT04170543 Completed - Clinical trials for Diabetic Kidney Disease

A Phase 2b Diabetic Kidney Disease Study

Start date: November 18, 2019
Phase: Phase 2
Study type: Interventional

A Phase 2b Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of MEDI3506 in Subjects with Diabetic Kidney Disease

NCT ID: NCT04170023 Terminated - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Study of the Oral Factor D (FD) Inhibitor ALXN2050 in PNH Patients as Monotherapy

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

The study will evaluate the efficacy and safety of the oral Factor D (FD) inhibitor ALXN2050 (ACH-0145228) monotherapy in patients with PNH that are treatment naïve, or patients currently treated with eculizumab who still experience anemia and reticulocytosis, or patients currently treated with ALXN2040 (danicopan) as monotherapy. After signing consent, participants will have periodic visits through Week 12, at which time the primary endpoint and key secondary assessments will be analyzed. Participants will continue on treatment past 12 weeks into a long-term extension portion of the trial.

NCT ID: NCT04169828 Active, not recruiting - Clinical trials for Juvenile Idiopathic Arthritis

The Ondansetron Premedication Trial in Juvenile Idiopathic Arthritis

OPT-JIA
Start date: August 2, 2019
Phase: N/A
Study type: Interventional

Far too many kids and families live in dread over the weekly nausea and vomiting caused by methotrexate - a medicine that controls joint swelling in Juvenile Arthritis patients. If methotrexate is not tolerated, expensive alternative biological medications may be started. This registry-based pragmatic randomized controlled trial will evaluate if routine premedication with the anti-emetic drug Ondansetron, reduces nausea and vomiting and increases the proportion of children able to continue methotrexate. By preventing nausea before it starts, the investigators hope to give kids and families a better quality of life and see a more cost-effective use of medication.

NCT ID: NCT04169373 Active, not recruiting - Spondyloarthritis Clinical Trials

A Study to Evaluate Efficacy and Safety of Upadacitinib in Adults With Axial Spondyloarthritis

SELECT-AXIS 2
Start date: November 26, 2019
Phase: Phase 3
Study type: Interventional

This protocol includes 2 standalone studies with randomization, data collection, analysis and reporting conducted independently. The main objectives of this protocol are: - To evaluate the efficacy of upadacitinib compared with placebo on reduction of signs and symptoms in adults with active axial spondyloarthritis (axSpA) including biologic disease-modifying antirheumatic drug inadequate responders (bDMARD-IR) ankylosing spondylitis (AS) (Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA) (Study 2). - To assess the safety and tolerability of upadacitinib in adults with active axSpA including bDMARD-IR AS (Study 1) and nr-axSpA (Study 2). - To evaluate the safety and tolerability of upadacitinib in extended treatment in adult participants with active axSpA including bDMARD-IR AS who have completed the Double-Blind Period (Study 1) and nr-axSpA who have completed the Double-Blind Period (Study 2). - To evaluate the maintenance of disease control after withdrawal of upadacitinib.

NCT ID: NCT04169191 Active, not recruiting - Birth Asphyxia Clinical Trials

Sildenafil to Repair Brain Injury Secondary to Birth Asphyxia

SANE-02
Start date: September 19, 2019
Phase: Phase 1
Study type: Interventional

The investigators will determine the maximum tolerable dose of sildenafil and establish the pharmacokinetic and pharmacodynamic profile of sildenafil in human asphyxiated neonates treated with hypothermia. They will use a 3+3 design to escalate the sildenafil dose up to 6 mg/kg/day (3mg/kg/dose q12h) in asphyxiated neonates demonstrating brain injury despite hypothermia treatment and assess whether we observe any beneficial effects of sildenafil on their brain and cardiopulmonary hemodynamics, without causing serious adverse events

NCT ID: NCT04168515 Recruiting - Delirium Clinical Trials

Lived Experiences and Impact of Delirium in Critically Ill Children: a Qualitative Study

Start date: September 10, 2019
Phase:
Study type: Observational

The investigators aim to conduct a qualitative study evaluating the long and short-term recollection and experiences of critically ill children with delirium as well as collect the lived experience of the caregiver and healthcare provider involved in the patient's care. The investigators objective is to determine if there are common themes to these experiences, and if these themes are associated with specific pediatric delirium subtypes (hypoactive, hyperactive, and mixed). The overall goal is to better understand the impact of delirium on patients and their caregivers, and develop strategies to improve education, prevention and management when caring for children with pediatric intensive care unit(PICU)-acquired delirium.

NCT ID: NCT04168385 Active, not recruiting - Clinical trials for Cholestatic Liver Disease

MRX-800: A Long-Term Safety Study of Maralixibat in the Treatment of Cholestatic Liver Disease in Subjects Who Previously Participated in a Maralixibat Study

MERGE
Start date: January 16, 2020
Phase: Phase 2
Study type: Interventional

Evaluate the long-term safety of maralixibat (MRX) in subjects with cholestatic liver disease including, but not limited to, Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC) and Biliary Atresia.