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NCT ID: NCT02433613 Completed - Atrial Fibrillation Clinical Trials

Postmarket Evaluation of the Phased Radio Frequency Ablation System (GOLD AF Registry)

Start date: March 2015
Phase:
Study type: Observational [Patient Registry]

Prospective, multi-center, single-arm, non-interventional and open-label registry. The purpose of the registry is to document use of Phased Radio Frequency Ablation (RFA) (hereafter "Phased RFA") System in a real world patient population with atrial fibrillation (AF) and evaluate its performance. Gold AF will enroll a minimum of 1,000 patients who undergo Phased RFA in approximately 38 sites in Western, Central Europe, Israel and South Korea.

NCT ID: NCT02433379 Completed - Clinical trials for Ventricular Tachycardia

Understanding Outcomes With the EMBLEMâ„¢ S-ICD in Primary Prevention Patients With Low Ejection Fraction

UNTOUCHED
Start date: June 9, 2015
Phase: N/A
Study type: Interventional

This study assesses the 18-month incidence of inappropriate shocks in subjects implanted with the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) for primary prevention of sudden cardiac death. Devices are to be programmed with zone cutoffs at 200 bpm and 250 bmp in order to mimic the programming settings for transvenous ICDs in the MADIT RIT study. The incidence of inappropriate S-ICD shocks will be compared to the incidence of inappropriate shocks observed in the MADIT RIT study.

NCT ID: NCT02431780 Completed - Epilepsy Clinical Trials

A Multicentre Clinical Investigation of a Decision Support Algorithm for Neonatal Seizure Detection

ANSeR
Start date: February 12, 2015
Phase: N/A
Study type: Interventional

The ANSeR Clinical Investigation is a multi-centre, randomised, controlled, clinical investigation of a standalone decision support Algorithm for Neonatal Seizure Recognition, the ANSER Software system.

NCT ID: NCT02429791 Completed - HIV Infections Clinical Trials

Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-1)

Start date: April 14, 2015
Phase: Phase 3
Study type: Interventional

The aim of this study is to determine if virologically suppressed human immunodeficiency virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will primarily assess the non-inferiority antiviral activity of switching to DTG + RPV once daily compared to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR will include 2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a 148-week open-label treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria will participate in the Early Switch Phase where they will either switch from their CAR to DTG + RPV, or continue taking their CAR, until Week 52. At the end of Early Switch Phase, eligible participants will proceed to the Late Switch Phase where all participants in both DTG + RPV and CAR treatment groups will receive DTG + RPV therapy until Week 148. After Week 148, subjects may be eligible to continue to receive DTG +RPV in the Continuation Phase. The study is planned to be conducted in approximately 476 participants.

NCT ID: NCT02429050 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Morphine for Treatment of Dyspnea in Patients With COPD

MORDYC
Start date: November 16, 2016
Phase: Phase 4
Study type: Interventional

Dyspnea is the most reported symptom of patients with advanced Chronic Obstructive Pulmonary Disease (COPD) and is undertreated. Morphine is an effective treatment for dyspnea and is recommended in clinical practice guidelines, but questions concerning benefits and concerns about respiratory adverse effects remain. For example, the effect on health-related quality of life and functional capacity is unknown. In one-third of the patients oral sustained release morphine (morphine SR) doesn't relieve dyspnea and it remains unknown whether severity and descriptors of breathlessness may predict a response to morphine. Finally, cost-effectiveness of morphine SR in this patient group is unknown. Therefore, prescription of morphine to patients with COPD is limited. Objectives of this double blind randomized controlled trial are to study the effect of oral administration of morphine SR on health-related quality of life, respiratory adverse effects, and functional capacity; to explore whether description and severity of breathlessness are related with a clinically relevant response to morphine and to analyse the cost-effectiveness of morphine SR. The study population will consist of 124 clinically stable outpatients with COPD and severe dyspnea despite optimal pharmacological and non-pharmacological treatment.

NCT ID: NCT02428946 Completed - Insulin Sensitivity Clinical Trials

Bromocriptine and Insulin Sensitivity

BIS
Start date: October 2014
Phase: N/A
Study type: Interventional

In this study the investigators will examine the effect of dopamine (bromocriptine) on insulin sensitivity in lean and obese subjects. Furthermore, the investigators will examine whether the timing of bromocriptine administration has influence on insulin sensitivity. To do so, the investigators will include lean and obese subjects who will use 2 times 2 weeks bromocriptine. In randomized order, they will use it in the morning or in the evening. The investigators will examine insulin sensitivity by performing a 7-point oral glucose tolerance test. Furthermore, the investigators will examine energy expenditure and subjects will keep track of their eating behaviour in the 3 days before each study visit.

NCT ID: NCT02428933 Completed - Obesity Clinical Trials

Dopaminergic Effects on Brown Adipose Tissue

DEBAT
Start date: October 2013
Phase: N/A
Study type: Interventional

In this study the investigators will investigate the effect of dopamine (bromocriptine) on Brown Adipose Tissue in lean, young, healthy males. The investigators will also examine energy expenditure, body temperature and insulin sensitivity as measurements of Brown Adipose Tissue activity.

NCT ID: NCT02428842 Completed - Cervical Cancer Clinical Trials

Biomarker Evaluation in Advanced Stage Cervical Cancer by an International Working Group. Tumor Stages (1B1 - 4)

BIO-RAIDs
Start date: October 24, 2013
Phase: N/A
Study type: Interventional

Prospective Multicentric European trial for Cervical cancer, not previously treated, with tumour biopsies, and blood collection for molecular analysis at predetermined time points.

NCT ID: NCT02426879 Completed - Cancer Clinical Trials

Esophagectomy for Patients With Esophageal Cancer and Cervical Lymph Node Metastases

Node
Start date: February 11, 2015
Phase: N/A
Study type: Interventional

There is no world-wide consensus on the oncological benefit versus increased morbidity associated with three field lymphadenectomy in patients with esophageal cancer and cervical lymph node metastases. In Asian countries, esophagectomy is commonly combined with a three field lymphadenectomy, including resection of cervical, thoracic and abdominal lymph nodes. However, in Western countries patients with cervical lymph node metastases are generally precluded from curative treatment.

NCT ID: NCT02426333 Completed - Clinical trials for Metastatic Castration Resistant Prostate Cancer

Optimizing Abiraterone Therapy

OPTIMUM
Start date: January 2016
Phase:
Study type: Observational

The purpose of this study is to explore whether early abiraterone exposure is related to treatment response in patients with metastatic castration resistant prostate cancer. Furthermore to explore the relation between biomarkers and treatment response and drug exposure.