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NCT ID: NCT01464476 Terminated - Clinical trials for Cardiovascular Diseases

Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2)

SHIELD-2
Start date: November 2011
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs)

NCT ID: NCT01459913 Terminated - Clinical trials for Hepatitis C, Chronic

Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype

CONCISE
Start date: November 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver.

NCT ID: NCT01458119 Terminated - Fabry Disease Clinical Trials

Open-Label Phase 3 Long-Term Safety Study of Migalastat

AT1001-041
Start date: October 14, 2011
Phase: Phase 3
Study type: Interventional

This was a long-term, open-label study of migalastat (123 milligrams [mg] of migalastat [equivalent to 150 mg of migalastat hydrochloride]) (migalastat) in participants with Fabry disease who completed treatment in a previous monotherapy trial with migalastat.

NCT ID: NCT01456234 Terminated - Influenza Clinical Trials

Time to Oseltamivir Access When Prescribed by Pharmacists Versus Physicians (ACCESS)

Access
Start date: November 2011
Phase: Phase 4
Study type: Interventional

The main purpose of this study is to see if patients with the flu would receive oseltamivir treatment more quickly if it were prescribed by a pharmacist as compared to a physician, and to see if there is any difference in the effect of treatment on flu symptoms and overall health. Another reason for doing the study is to see how accurately pharmacists can diagnose the flu as compared to physicians. Viruses that are exposed to antiviral medications (like oseltamivir) sometimes develop a resistance to the medication. This means that the medication is no longer as effective in treating the symptoms caused by the virus. The development of viral resistance to oseltamivir will also be followed in this study.

NCT ID: NCT01455948 Terminated - Clinical trials for Chronic Rhinosinusitis

Canadian Health Economics, Outcome, and Effectiveness Comparison of Treatment in Patients With Chronic Rhinosinusitis

CHEC
Start date: February 2012
Phase: Phase 4
Study type: Interventional

The economic, patient related outcome, and effectiveness of balloon sinuplasty in the treatment of CRS patients with frontal and other sinus disease in the Canadian healthcare environment is not known at this time. This study will evaluate the impact of balloon sinuplasty and traditional FESS treatment on CRS patients.

NCT ID: NCT01452347 Terminated - Clinical trials for Heart Valve Diseases

Dabigatran Etexilate in Patients With Mechanical Heart Valves

RE-ALIGN
Start date: October 2011
Phase: Phase 2
Study type: Interventional

To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.

NCT ID: NCT01447901 Terminated - Clinical trials for Hyperlipoproteinemia Type I

Duration of Effect of Alipogene Tiparvovec Treatment, Which Was Administered in Other Studies

Start date: September 2011
Phase: N/A
Study type: Observational

LPL (Lipoprotein Lipase) is an enzyme which plays an important role in the elimination of triglycerides (fat) and the clearance of dietary fat particles known as chylomicrons (CM) in the blood. In patients who have an abnormal LPL gene, the enzyme does not work (total, hereditary LPL deficiency), which results in a large increase in the amount of triglycerides (fats) and chylomicrons in the blood. This increases the risk of inflammation in the pancreas and leads to long term negative effects for bloods vessels (atherosclerosis). Current medications and / or a strict and low fat diet do not sufficiently reduce the level of triglycerides in order to prevent these conditions. To solve this problem, the company, AMT is developing a gene therapy (AMT-011). In normal healthy individuals, fat particles are rapidly cleared from the circulation following a standard meal. Within approximately 3 hours the highest levels of fat is reached and clearance is achieved within the subsequent 9 hours. In LPLD subjects, the clearance of fat is greatly reduced as a direct consequence of the lack of LPL. During this study, a standard meal with a tracer (3H-palmitate) is given. Since palmitate is incorporated in the dietary fat, this study enabled monitoring of appearance of newly formed dietary fat into- and clearance of these newly formed dietary fats from the circulation, over time. The principal aim of the study is to verify if the gene therapy (AMT 011) is still effective in the treatment of this condition. Systemic appearance and clearance of new formed dietary fat particles after ingestion of the meal will be determined by measuring the level of tracer at different time points.

NCT ID: NCT01439542 Terminated - Prostate Cancer Clinical Trials

FASTR: Fairly Brief Androgen Suppression and Stereotactic Radiotherapy for High Risk Prostate Cancer

FASTR
Start date: September 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to examine the safety of a shorter course of radiation treatments combined with one year of androgen deprivation therapy. The study will test this treatment in men with high risk prostate cancer who have significant other illnesses or circumstances such that conventional long term radiotherapy and hormone therapy is not recommended by their physician or desired by the patient.

NCT ID: NCT01438008 Terminated - Clinical trials for Pain Due to Certain Specified Procedures

Pilot Study of Sucrose to Reduce Pain in Sick Babies

Start date: May 2012
Phase: Phase 4
Study type: Interventional

Small amounts of sweet tasting sugar water reduces pain in babies during painful blood tests and injections. The investigators do not know if sugar also reduces pain in babies already receiving a continuous infusion of opioid analgesics. This project will help determine if small amounts of sugar water reduce pain in babies already receiving a continuous infusion of opioid analgesic during a heel lance procedure or nasogastric/orogastric (NG/OG) tube insertions. The investigators hypothesize that infants who are receiving opioid analgesics will have lower pain scores during their blood tests (heel lance) or NG/OG tube insertion, when sucrose is given, compared to when water is given.

NCT ID: NCT01436175 Terminated - Clinical trials for Major Depressive Disorder

SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study

Start date: February 27, 2012
Phase: Phase 3
Study type: Interventional

This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if they completed a previous double-blind MDD augmentation study using SPD489.