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NCT ID: NCT02974153 Completed - Migraine Disorders Clinical Trials

Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine

PROMISE 2
Start date: November 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of migraine headache in chronic migraineurs.

NCT ID: NCT02973204 Completed - Clinical trials for Neuroendocrine Tumors

Circulating Tumor Cells and Tumor DNA in HCC and NET

Start date: November 2016
Phase:
Study type: Observational [Patient Registry]

Background Treatment and control of cancer is associated with high costs, to patients in the form of side effects and discomfort during investigations, to society in the form of expensive drugs and studies. Circulating tumor cells (CTC) has received great attention as a cancer biomarker in trying to estimate future course in patients with breast cancer, colon cancer and prostate cancer. CTC is believed to be a crucial step in cancer spreading to the bloodstream and giving rise to metastases. Detection of circulating tumor DNA (ctDNA) specifically adds specificity to the analysis of the CTC. The investigators would like to with molecular biological methods predict which patients requires special monitoring and individualized therapy and explore these tests as clinical decision support. Purpose and method In a blood sample from patients with neuro-endocrine tumor (NET) and hepatocellular carcinoma (HCC), the investigators will by cell separation, flow cytometry and DNA sequencing and digital polymerase chain reaction (PCR): 1. Identify and isolate the CTC and investigate these for tumor-specific mutations. 2. Quantify ctDNA and analyze this for specific mutations, which in the past has been found frequent in NET and HCC. 3. Compare findings of mutations on CTC and ctDNA with mutations in tissue biopsies. The results are compared with the clinical data on disease course, including the effect of treatment and survival. Subjects 40 Patients with small intestinal/unknown primary NET before treatment with somatostatin analogues 30 patients with pancreatic NET before treatment with Everolimus 30 patients with presumed radically treated HCC 30 patients with HCC in treatment with Sorafenib A blood sample will be taken prior to the start of treatment, after 1 month after start of treatment and thereafter every 3.-6. month for up to two years. Perspectives In several cancer types molecular diagnostics have had significant influence in treatment and control strategy. The goal is in future to be able to take advantage of a so-called "liquid biopsy" as clinical decision support. The study will bring new knowledge to this growing field of research.

NCT ID: NCT02970942 Completed - Clinical trials for Non-alcoholic Steatohepatitis

Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.

Start date: November 30, 2016
Phase: Phase 2
Study type: Interventional

Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis

NCT ID: NCT02969395 Completed - Clinical trials for Cardiac Rhythm Disorder

3T MRI CIED Post-Approval Study

Start date: April 2016
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to evaluate product performance of Magnetic Resonance (MR) Conditional Cardiac Implantable Electronic Devices (CIED) following 3 tesla (3T) MRI exposure. This will be achieved by evaluating the changes in pacing capture threshold (PCT) measurements following 3T MRI scan exposure. This study is required by FDA as a condition of approval of 3T MRI compatible labeling of applicable CIED systems. This study is conducted within Medtronic's post-market surveillance platform, the Product Surveillance Registry (PSR).

NCT ID: NCT02969200 Completed - Fabry Disease Clinical Trials

Fabry: Renal Function During Long-term ERT by 51Cr-EDTA Clearance

Start date: April 2015
Phase:
Study type: Observational

The aim of this study was to investigate renal function decline by measured glomerular filtration rate (mGFR) in patients with FD during enzyme replacement therapy, and to explore the influence of age on renal function in FD.

NCT ID: NCT02969135 Completed - Rotator Cuff Tear Clinical Trials

Progressive Active Exercise After Surgical Rotator Cuff Repair

Start date: February 26, 2017
Phase: N/A
Study type: Interventional

Shoulder disorders are extremely common, with a life-time prevalence in population of 30%. About 23% of the working population with shoulder problems are sick-listed. Specifically rotator cuff tears are considered some of the principal causes of chronic shoulder pain and disability, especially with advancing age. The National Patient Register in Denmark has registered 730 rotator cuff repairs in 2006 and 990 in 2012, which represents a 35% increase. A rotator cuff tear is defined as a rupture of the tendon (s) of the shoulder, and most frequently involves the supraspinatus and/or the infraspinatus tendon, resulting in loss of function due to pain and tissue weakness. Little is known about the effects of the postoperative training/rehabilitation, and this provides an unclear picture of the total treatment procedure of this condition. The Danish National Clinical Guidelines from 2013 recommend that these patients are offered rehabilitation and that the shoulder is immobilized post-surgery, but the evidence for postoperative training is moderate- low. The past few years, there have been conducted 5 systematic reviews looking at different rehabilitation parameters after rotator cuff surgery. They conclude that early Range-Of-Motion exercise accelerate healing, reduce stiffness, do not increase risk of re-rupture and that immobilization do not increase tendon healing or clinical outcome. They also conclude that there is a further need to evaluate approaches that foster early initiation of rehabilitation and gradual introduction of functional load in high-quality, adequately powered trials, also considering key outcomes such as return to work. Therefore, the aim of this study is to compare the effect of a progressive early passive and active movement protocol with a care as usual (limited early passive movement protocol) on tendon healing, physical function, pain, and quality of life, in patients operated due to traumatic full thickness rotator cuff tear in a Randomized Controlled Trial. Shortterm effects of physical function, pain, and quality of life will be studied as primary patient reported outcome, while secondary outcomes will be clinical and paraclinical outcomes in addition to the longterm effects of physical function, pain, and quality of life.

NCT ID: NCT02967744 Completed - Osteoarthritis,Knee Clinical Trials

NSAID Treatment of Patients With Osteoarthritis

Start date: January 2016
Phase: N/A
Study type: Interventional

The study investigates associations between pre treatment pain intensity and central pain mechanisms on the effect of 8-week treatment of NSAIDs in patients with knee osteoarthritis.

NCT ID: NCT02965625 Completed - Clinical trials for Coronary Artery Disease

Characterization of Epicardial and Pericardial Adipose Tissue in Coronary Artery Disease

Start date: October 2016
Phase:
Study type: Observational

Human epicardial fat is the true visceral fat depot of the heart, and its regional distribution and physiology is of growing scientific and clinical interest. This study aims to characterize the expression profile and function of the epicardial and pericardial adipose tissue compartments of the heart (EAT and PAT). EAT and PAT adipose biopsies will be obtained from patients undergoing coronary artery bypass graft surgery (CABG) or valve replacement surgery.

NCT ID: NCT02965144 Completed - Depression Clinical Trials

Long Term Survivors of High-grade Glioma and Their Caregivers

Start date: December 2016
Phase:
Study type: Observational

This study builds on the limited body of existing literature combined with the results from the investigators' previous research conducted with 30 newly diagnosed patients with high-grade glioma (HGG) and 33 of their caregivers. This research established an overview of the daily life experiences when diagnosed with a HGG or being a caregiver. Descriptions of needs and preferences from time of diagnosis to one year exist. However, such data are still lacking the representation from long-term survivors (LTS) and their caregivers. This mixed methods study aims to address perspectives on daily life experiences of long-term survivors with HGG and their caregivers as well as the needs and preferences for support, rehabilitation and palliation. Separate telephone interviews with patients and their caregivers and self-reported questionnaires for patients will be conducted. The mixed methods design is a convergent sequential design using an identical sampling.

NCT ID: NCT02965105 Completed - Clinical trials for Incontinence, Urinary

Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy Volunteers

Start date: November 2016
Phase: N/A
Study type: Interventional

The aim of the study is to test the performance and safety of a newly developed intermittent catheter