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NCT ID: NCT03545659 Completed - Recurrence Clinical Trials

Childhood Acute Lymphoblastic Leukaemia: Follow-Up

Start date: September 4, 2018
Phase:
Study type: Observational

Over the past decades, advances in treatment have led to an increasing number of children who survive cancer, resulting in a growing population of childhood cancer survivors. After end of cancer treatment on common protocols survivors are enrolled in non-harmonized follow-up programs with frequent visits and blood samples. However, the evidence for the value of these follow-up programs with respect to the effect on detecting relapse and the effects on overall survival is scarce. The aim of the study is to give a comprehensive description of the detection mode of relapsed acute lymphoblastic leukaemia (ALL), including symptoms and blood test results. Further, we aim to evaluate if the mode of detection affects survival.

NCT ID: NCT03541174 Completed - Clinical trials for Resistant Hypertension

A Research Study to Show the Effect of Aprocitentan in the Treatment of Difficult to Control (Resistant) High Blood Pressure (Hypertension) and Find Out More About Its Safety

PRECISION
Start date: June 18, 2018
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to show the blood pressure lowering effect of aprocitentan, a new drug, when added to other anti-hypertensive drugs of patients with difficult to control (resistant) high blood pressure (hypertension), and to show that blood pressure reduction is kept for long period of time.

NCT ID: NCT03537391 Completed - Clinical trials for High Risk Prostate Cancer

Novel Imaging in Staging of Primary Prostate Cancer

PROSTAGE
Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Prostate cancer (PC) is the most common cancer among men and one quarter of diagnosed PC are metastatic at the time of diagnosis. Accurate staging is paramount as the stage is the most important factor when treatment decisions are made. The stage is also the single most important prognostic factor. Currently, traditional imaging methods for detection of PC metastasis, including bone scan (BS) and contrast enhanced whole-body computer tomography (CT), are rather inaccurate. Respectively, novel imaging techniques are evolving and novel imaging modalities are emerging in PC diagnostics and staging, but their clinical relevance is unclear and lacking prospective studies comparing traditional imaging with novel imaging. This prospective single-institutional study compares the diagnostic accuracy of novel imaging modalities to traditional imaging modalities aiming to find the most appropriate staging modality in high-risk PC at the time of initial staging.

NCT ID: NCT03537027 Completed - Clinical trials for Vitamin D Receptor Target Gene Expression

Efficiency of Vitamin D3 and 25-hydroxyvitamin D3 on Transcriptomic Changes of Low Vitamin D Responders

VitDHiD
Start date: May 3, 2018
Phase: Phase 1
Study type: Interventional

The purpose of the study is to investigate in vivo whether a high-dose vitamin D3 oral bolus (2000 micrograms) produces marked vitamin D receptor target gene expression response and whether there is large inter-individual variation. These effects are compared to in vitro treatment of peripheral blood mononuclear cells from these subjects with 25(OH)D.

NCT ID: NCT03533114 Completed - Clinical trials for Idiopathic Hypersomnia

A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension

Start date: November 27, 2018
Phase: Phase 3
Study type: Interventional

This is a study of the efficacy and safety of JZP-258, an oxybate mixed-salts oral solution being developed as a low sodium alternative product for Xyrem.

NCT ID: NCT03510884 Completed - Clinical trials for Hypercholesterolaemia

An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia

Start date: May 31, 2018
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the efficacy of alirocumab administered every 2 weeks (Q2W) and every 4 weeks (Q4W) versus placebo after 24 weeks of double-blind (DB) treatment on low-density lipoprotein cholesterol (LDL-C) levels in participants with heterozygous familial hypercholesterolemia (heFH) 8 to 17 years of age on optimal stable daily dose of statin therapy ± other lipid modifying therapies (LMTs) or a stable dose of non-statin LMTs in case of intolerance to statins. Secondary Objectives: - To evaluate the efficacy of alirocumab versus placebo on LDL-C levels. - To evaluate the effects of alirocumab versus placebo on other lipid parameters. - To evaluate the safety and tolerability of alirocumab in comparison with placebo. - To evaluate the efficacy, safety, and tolerability of alirocumab after open label treatment. - To evaluate the development of anti-alirocumab antibodies.

NCT ID: NCT03507452 Completed - Clinical trials for Advanced Recurrent Malignant Peritoneal Epithelioid Mesothelioma

First-in-human Study of BAY2287411 Injection, a Thorium-227 Labeled Antibody-chelator Conjugate, in Patients With Tumors Known to Express Mesothelin

Start date: June 13, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate, in patients with tumors known to express the protein mesothelin, the following properties of BAY2287411 injection: - safety (to identify, assess, minimize, and appropriately manage the risks associated to the study drug) - tolerability (the degree to which side effects can be tolerated by your body) - maximum tolerated dose - pharmacokinetics (the effect of your body on the study drug) - anti-tumor activity - recommended dose for further clinical development

NCT ID: NCT03507335 Completed - Stroke Clinical Trials

Atrial Fibrillation Detection: 24 Hour Study

AFIB24h
Start date: April 9, 2018
Phase:
Study type: Observational

Aims Approximately 20-25% of strokes are of cardioembolic origin, atrial fibrillation (AF) being a significant cause of cardioembolic strokes. AF is often symptomless and intermittent, making its detection a clinical challenge. Currently the golden standard for diagnosis of AF is by 12-lead electrocardiogram (ECG) or any other ECG-strip. The primary aim of the study is to assess the potential of chest strap as an ECG monitor especially in arrhythmia detection by cardiologist and algorithm. The secondary aim is to assess potential of photoplethysmography (PPG) based device for arrhythmia detection.

NCT ID: NCT03505021 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS

REFALS
Start date: June 21, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate whether prolonged oral levosimendan can preserve respiratory function more effectively than placebo, resulting in better patient functionality as measured by the ALSFRS-R scale. In this randomized, double-blind, placebo-controlled, parallel-group, multicenter study, subjects are allocated in a 2:1 ratio to receive either levosimendan (1 -2 mg daily) or placebo for 48 weeks. The primary endpoint is slow vital capacity (SVC) at 12 weeks, with the impact on patient function assessed through 48 weeks, adjusted for patient outcome, using ALSFRS-R (combined assessment of function and survival, CAFS). Other important efficacy measures include time to respiratory events, clinical global impression (CGI), assessment of dyspnea using the Borg scale and sleep scales (Pittsburgh sleep quality index and Epworth sleepiness scale). Patient safety is monitored using conventional methods including adverse events, safety laboratory tests, vital signs and 12-lead EKG. Following screening and baseline visits, patients attend the clinic at 2, 4, 8, 12, 24, 36 and 48 weeks, with telephone assessments conducted at weeks 18, 30 and 42. An end of study visit is performed 14-25 days after the last study treatment administration. The study will be monitored by an independent data and safety monitoring board. A long-term extension study will be available for patients completing the study.

NCT ID: NCT03501797 Completed - Stroke Clinical Trials

Choir Singing in Aphasia Rehabilitation

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

This study evaluates the verbal, cognitive, emotional, and neural efficacy of a choir singing intervention in chronic aphasic patients and their caregivers. Using a cross-over RCT design, half of the participants receive a 4-month singing intervention during the first half of the study and half of the participants during the second half of the study.