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NCT ID: NCT01965899 Active, not recruiting - Syncope Clinical Trials

Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System

Start date: September 2013
Phase: N/A
Study type: Interventional

The purpose of the Reveal LINQ Usability Study is to assess the functionality of the Reveal LINQ insertable cardiac monitor and accompanying system in patients indicated for an insertable cardiac monitor

NCT ID: NCT01965652 Completed - Clinical trials for Opioid-induced Constipation

Long Term Safety of Naldemedine

Start date: September 24, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.

NCT ID: NCT01965223 Completed - Cancer Clinical Trials

A Randomized Phase II Study of Stereotactic Ablative Body Radiotherapy for Metastases to the Lung (TROG 13.01 SAFRON II)

SAFRON II
Start date: February 4, 2015
Phase: N/A
Study type: Interventional

The main purpose of this study is to determine the safety (defined as number of participants experiencing ≥ 5% toxicity at 12 months post treatment) of stereotactic ablative fractionated radiotherapy versus radiosurgery for oligometastatic neoplasia to the lung.

NCT ID: NCT01964560 Completed - Epilepsy Clinical Trials

A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures

Start date: August 13, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.

NCT ID: NCT01964430 Completed - Neoplasms Clinical Trials

Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)

apact
Start date: March 28, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone.

NCT ID: NCT01964235 Withdrawn - Clinical trials for Advanced Hepatocellular Carcinoma

Study of Efficacy and Safety INC280 in Patients With Advanced Hepatocellular Carcinoma

Start date: December 2016
Phase: Phase 2
Study type: Interventional

This study is establish whether INC280 is safe and has beneficial effects in patients with advanced hepatocellular carcinoma known to have dysregulation of c-MET pathway and whose disease progressed while on, or after, treatment with sorafenib or who are intolerant to sorafenib. Patients will be randomized in a 2:1 ratio to receive INC280 at 600mg BID plus best supportive care (BSC) or placebo plus BSC, until disease progression or intolerable to study treatment. Patients treated with placebo plus BSC will have the opportunity to receive INC280 treatment upon documented further disease progression (RECIST 1.1) per investigator's discretion after unblinding. Patient will be stratified to geographical region (Asia vs Rest of World ) and tumor burden (present macroscopic vascular invasion and/or extra-hepatic spread vs not present).

NCT ID: NCT01963208 Completed - Clinical trials for Drug Resistant Partial Onset Seizure

Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension

Start date: October 2013
Phase: Phase 3
Study type: Interventional

The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs).

NCT ID: NCT01962818 Completed - Clinical trials for Bronchopulmonary Dysplasia

High Frequency Oscillatory Ventilation Combined With Intermittent Sigh Breaths: Effects on Lung Volume Monitored by Electric Tomography Impedance.

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

Background Ventilator induced lung injury (VILI) remains a problem in neonatology. High frequency oscillatory ventilation (HFOV) provides effective gas exchange with minimal pressure fluctuation around a continuous distending pressure and therefore small tidal volume. Animal studies showed that recruitment and maintenance of functional residual capacity (FRC) during HFOV ("open lung concept") could reduce lung injury. "Open lung HFOV" is achieved by delivering a moderate high mean airway pressure (MAP) using oxygenation as a guide of lung recruitment. Some neonatologists suggest combining HFOV with recurrent sigh-breaths (HFOV-sigh) delivered as modified conventional ventilator-breaths at a rate of 3/min. The clinical observation is that HFOV-sigh leads to more stable oxygenation, quicker weaning and shorter ventilation. This may be related to improved lung recruitment. Electric Impedance Tomography (EIT) enables measurement and mapping of regional ventilation distribution and end-expiratory lung volume (EELV). EIT generates cross-sectional images of the subject based on measurement of surface electrical potentials resulting from an excitation with small electrical currents and has been shown to be a valid and safe tool in neonates. Purpose, aims: - To compare HFOV-sigh with HFOV-only and determine if there is a difference in global and regional EELV (primary endpoints) and spatial distribution of ventilation measured by EIT - To provide information on feasibility and treatment effect of HFOV-sigh to assist planning larger studies. We hypothesize that EELV during HFOV-sigh is higher, and that regional ventilation distribution is more homogenous. Methods: Infants at 24-36 weeks corrected gestational age already on HFOV are eligible. Patients will be randomly assigned to HFOV-sigh (3 breaths/min) followed by HFOV-only or vice versa for 4 alternating 1-hours periods (2-treatment, double crossover design, each patient being its own control). During HFOV-sigh set-pressure will be reduced to keep MAP constant, otherwise HFOV will remain at pretrial settings. 16 ECG-electrodes for EIT recording will be placed around the chest at study start. Each recording will last 180s, and will be done at baseline and at 30 and 50 minutes after each change in ventilator modus. Feasibility No information of EIT-measured EELV in babies on HFOV-sigh exists. This study is a pilot-trial. In a similar study-protocol of lung recruitment during HFOV-sigh using "a/A-ratio" as outcome, 16 patients was estimated to be sufficient to show an improvement by 25%. This assumption was based on clinical experience in a unit using HFOV-sigh routinely. As the present study examines the same intervention we assume that N=16 patients will be a sufficient sample size. We estimate to include this number in 6 months.

NCT ID: NCT01962467 Completed - Clinical trials for Rhinitis, Allergic, Perennial and Seasonal

A Relative Bioavailability Study of Fluticasone Furoate and Levocabastine

Start date: October 11, 2013
Phase: Phase 1
Study type: Interventional

This is an open label, randomized, 3-way cross-over, and repeat administration study in healthy male and female subjects. The purpose of the study is to determine the relative bioavailability of Fluticasone Furoate (FF) and Levocabastine (LEV), when each is administered alone and as FF/LEV Fixed Dose Combination (FDC).This study consists of Part A (in which 30 subjects including 12 Korean subjects will be enrolled) and Part B (in which 18 subjects will be enrolled). Each part will consist of three treatment periods separated by a minimum washout period of 14 days. In each treatment period, subjects will receive seven daily doses of one of the 3 treatments: FF, LEV or FF/LEV FDC, via an intranasal spray according to one of the 6 possible randomization sequences. The study will use an adaptive design with an interim review following Part A to confirm whether Part B is required.

NCT ID: NCT01962441 Active, not recruiting - Hepatitis C Clinical Trials

SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection

Start date: September 2013
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+peginterferon alfa-2a (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV infection.