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NCT ID: NCT02271633 Completed - Blood Pressure Clinical Trials

Nitrate Supplementation; Source

NO-what
Start date: September 2014
Phase: Phase 4
Study type: Interventional

The main aim of the current study will be to compare the effects of ingesting different nitrate-rich sources on plasma nitrite concentrations.

NCT ID: NCT02270749 Completed - Clinical trials for Vitamin B12 Deficiency

Vitamin Deficiencies and Suppletion in Morbid Obesity

Start date: October 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the most effective treatment for patients who underwent a Roux-en-Y gastric bypass and developed postoperatively a vitamin B12 deficiency.

NCT ID: NCT02270151 Completed - Atrial Fibrillation Clinical Trials

Improving DEtection of Atrial fibriLlation in Primary Care With the MyDiagnostick

IDEAL-MD
Start date: November 2014
Phase: Phase 3
Study type: Interventional

Atrial fibrillation (AF) is the most common arrhythmia and a common cause of stroke. AF can be asymptomatic and remain undiagnosed. Both the prevalence of AF and the proportion of strokes related to undetected AF increases with ageing. If AF is timely diagnosed and treated accordingly with anticoagulants, disabling strokes can be prevented. In order to help physicians in diagnosing atrial fibrillation, the MyDiagnostick was developed. It is a CE certified device that is safe, user friendly and easy to use. This device is capable of detecting or excluding AF within one minute by providing a registration of lead I of the ECG. The investigators aim to perform a 2-arm cluster randomized diagnostic trial among patients aged 65 years and over who visit the general practice. In total the investigators will include 42 general practices of which they randomly assign 21 to the MyDiagnostick arm and 21 to the control arm. All persons aged 65 years and over who visit the general practice in the MyDiagnostick arm will be asked to hold the device every time they visit the surgery during one year. The number of newly detected cases of AF with the diagnostic screening strategy with MyDiagnostick (MyDiagnostick arm) will be compared to care as usual (control arm). Also, the number of patients treated with anticoagulants according CHA2DS2-VASc score will be compared between both arms. Finally, the investigators will assess the number of major adverse cardiovascular events (MACE), intracerebral hemorrhages and other major hemorrhages, and all-cause mortality between the arms. End points will be assessed blinded to allocation. The investigators hypothesise that the MyDiagnostick improves the diagnosis of atrial fibrillation in primary care and with accordingly treatment will reduce adverse outcomes.

NCT ID: NCT02269254 Completed - Clinical trials for Musculoskeletal Diseases

Persona Versus NexGen

Start date: September 2014
Phase: N/A
Study type: Interventional

The NexGen TKR (Zimmer, Warsaw, Indiana, USA) is a proven TKR design that has reported excellent medium and long-term results in clinical studies and in implant registries all around the world. As a follow-up of the NexGen TKR, an improved design has recently been introduced by Zimmer: The Persona TKR (Zimmer, Warsaw, Indiana, USA) has been used successfully in about 20.000 patients, but results from independent clinical studies have not been reported yet. The objective of this study is to accurately assess and compare migration, kinematics, prosthesis placement and patient reported outcomes of two TKR prostheses: the fixed bearing, cemented NexGen LPS, a proven design with an excellent clinical track record, and the fixed bearing, cemented Persona PS, a new design without clinical data (both designs by Zimmer, Warsaw, Indiana, USA). The primary objective is to assess and compare migration of the two TKR prostheses (Femoral and Tibial component). The secondary objective is to assess and compare clinical data, kinematics, prosthesis placement and patient reported outcome measures. This study is designed as a single-blind randomized trial between the Persona PS total knee prosthesis and the well-established NexGen total knee prosthesis. Different sample sizes are used for the different parts of this study: - 30 Patients with NexGen LPS prosthesis and 30 patients with Persona PS prosthesis for RSA - 15 Patients with NexGen LPS prosthesis and 15 patients with Persona PS prosthesis for Fluo The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for TKR surgery at the Department of Orthopaedics, Leiden University Medical Center. Annually 40 TKA procedures are performed in our department, of which about 70% is Osteo Arthritis (OA) and 30% Reumatoid Arthritis (RA). We anticipate that inclusion can be accomplished within a 2 year period. Main study parameters/endpoints are: - Migration, measured by means of RSA. - Prosthesis placement and bone resection measured by means of CT and caliper measurements of the resected bone parts. - In vivo kinematics by means of fluoroscopy. - Patient Reported Outcome Measures by means of questionaires.

NCT ID: NCT02268357 Completed - Dental Anxiety Clinical Trials

The Effects of Propranolol on Fear of Tooth or Molar Extraction

Start date: November 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Randomized, placebo-controlled, double-blind, parallel group clinical trial evaluating the anxiolytic effects of propranolol on fear of wisdom tooth removal. It is hypothesized that, compared to placebo, perioperative oral propranolol reduces dental trait anxiety at 1 month follow-up after wisdom tooth removal.

NCT ID: NCT02265952 Completed - Clinical trials for Homozygous Familial Hypercholesterolemia

Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

Start date: February 4, 2015
Phase: Phase 2
Study type: Interventional

This is an open-label, single-arm study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia (HoFH).

NCT ID: NCT02265744 Completed - Lupus Clinical Trials

Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus

Start date: November 13, 2014
Phase: Phase 2
Study type: Interventional

Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the initial 24 weeks of treatment and who are responding to therapy will have the option to continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythematosus studies and patient self reporting.

NCT ID: NCT02265588 Completed - Depression Clinical Trials

Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD).

HAPPY-IBD
Start date: September 2014
Phase: N/A
Study type: Interventional

The presented study aims to reduce symptoms of depression and anxiety in adolescents with inflammatory bowel disease and increased symptoms of anxiety and depression by using the disease specific CBT program (PASCET-PI)in order to improve quality of life and to improve the clinical course of disease.

NCT ID: NCT02265549 Completed - Clinical trials for Metastases, Neoplasm

Radiomics for Prediction of Long Term Survival and Local Failure After Stereotactic Radiotherapy for Brain Metastases

Start date: May 2014
Phase: N/A
Study type: Observational

Published prognostic scores have limitations in prediction of long term survival after stereotactic radiotherapy for brain metastases. Moreover, no validated tools are available for prediction of local failure. The value of radiomics is evaluated in this perspective.

NCT ID: NCT02264990 Completed - Clinical trials for Non-squamous Non-small Cell Lung Cancer

Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

Start date: September 30, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in adults with metastatic or advanced non-squamous non-small cell lung cancer.