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NCT ID: NCT01715558 Completed - Bradyarrhythmia Clinical Trials

Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications OPTI-MIND 2

OPTI-MIND 2
Start date: February 2013
Phase: N/A
Study type: Observational

The purpose of the study is to demonstrate that reduction of unnecessary pacing provided by RYTHMIQ algorithm programed to ON in a pacemaker is associated with better clinical outcomes in bradycardia target population.

NCT ID: NCT01715285 Completed - Prostate Neoplasms Clinical Trials

A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)

Start date: February 12, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).

NCT ID: NCT01715272 Completed - Colonoscopy Clinical Trials

A Clinical Investigation to Demonstrate the Performance of a New Enema (TF037) in Distal Bowel Cleansing Compared With Fleet Enema

Start date: October 2012
Phase: Phase 1
Study type: Interventional

This study is designed to assess the difference between the performance of a new enema (TF037) against Fleet enema in distal bowel cleansing.

NCT ID: NCT01714778 Completed - Smoking Cessation Clinical Trials

Toxins and Delivery in e-Cigarette Users

TADEUS
Start date: February 2013
Phase: N/A
Study type: Observational

Electronic cigarettes or "e-cigarettes" (EC) may have a potential public health benefit as a safer alternative to smoking and possibly also as an aid in tobacco dependence treatment. However, there are concerns about their safety and whether they can deliver nicotine consistently and in doses necessary for such effects. To be able to consider the safety of ECs and their potential in harm reduction, data are needed comparing the exposure to the potential toxicant, acrolein, in smokers of conventional cigarettes, users of EC, and people who use both products at the same time. To accurately assess EC nicotine delivery, data are needed from people who use them regularly, as there is some evidence of higher and faster nicotine absorption in experienced users compared with naïve users who try them once in an artificial laboratory setting. This study will provide information on both of these issues. Forty smokers will be given EC to use, in addition to behavioural support, as part of a stop smoking attempt. Levels of acrolein and nicotine will be measured before and after 4 weeks of EC use.

NCT ID: NCT01714765 Completed - Clinical trials for Metastatic Clear Cell Renal Cancer

Dose Escalation Study Investigating Everolimus and Dovitinib in Metastatic Clear Cell Renal Cancer

DEVELOP
Start date: April 2011
Phase: Phase 1
Study type: Interventional

When kidney cancer spreads beyond the kidney, it is known as metastatic kidney cancer. This is very difficult to treat and almost all patients will die of their disease within 3 years. Sunitinib has become standard therapy for untreated patients with metastatic clear cell renal (kidney) cancer. It targets a growth factor known as VEGF which is important in treating renal cancer. Although the results with this drug are impressive, patients develop resistance to the drug, relapse and die of renal cancer. It is currently standard practice is to treat patients with everolimus when resistance to sunitinib occurs; this is associated with clear clinical benefit. However the median time to progression with everolimus is 4.9 months in previously treated patients, therefore further improvement in treating patients is required. The optimal way of achieving this is to increase the efficacy of everolimus by adding agents which directly target the cause of resistance to sunitinib. Dovitinib is a promising new drug in renal cancer. Dovitinib blocks cellular functions such as activation of downstream signalling molecules, cell proliferation and survival. Combining dovitinib and everolimus is very attractive. This trial is aimed to establish the maximum tolerated dose for the combination of dovitinib and everolimus in clear call renal cancer, which can then be taken into a randomised phase II study. A maximum of 30 patients will be recruited into this multi centre national trial. Expansion Cohort: The study has established the MAD and the MTD. The MTD was Cohort 0 (Everolimus 5mg and Dovitinib 200mg). 6 patients were recruited in this cohort with only 1 patient experiencing a DLT. A further 3 patients were recruited into Cohort 1 (Everolimus 5mg and Dovitinib 300mg), where 2 patients experienced a DLT. A total of 7 assessable patients will be recruited during the expansion phase at the MTD (Cohort 0: Everolimus 5mg and Dovitinib 200mg) to further define the safety, tolerability, efficacy, PK and biological end points. Assessable patients for the expansion cohort are defined as being on the study for a minimum of 6 weeks. Any patients enrolled who are not assessable will be replaced.

NCT ID: NCT01714713 Completed - Schizophrenia Clinical Trials

A 26-Week Extension Study of EVP-6124 (Alpha-7 nAChR) as an Adjunctive Pro-Cognitive Treatment in Schizophrenia Subjects on Chronic Stable Atypical Antipsychotic Therapy

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

This study is being conducted to further investigate the safety of prolonged exposure to EVP-6124 in subjects with Schizophrenia receiving a stable dose of an atypical antipsychotic who completed double-blind treatment on studies EVP-6124-015 and EVP-6124-016.

NCT ID: NCT01714635 Completed - Cataract Clinical Trials

Clinical Investigation of Expanded Designs of a Multifocal IOL

Start date: November 2012
Phase: Phase 1
Study type: Interventional

The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Multifocal 1-Piece Intraocular Lens (IOLs), Models ZKB00 and ZLB00 which will each provide statistically better distance-corrected near visual acuity compared to the monofocal control lens. Complication and adverse event rates associated with each Multifocal IOL will be within the ISO SPE rate for posterior chamber IOLs.

NCT ID: NCT01713946 Completed - Clinical trials for Tuberous Sclerosis Complex-associated Refractory Seizures

A Placebo-controlled Study of Efficacy & Safety of 2 Trough-ranges of Everolimus as Adjunctive Therapy in Patients With Tuberous Sclerosis Complex (TSC) & Refractory Partial-onset Seizures

EXIST-3
Start date: April 29, 2013
Phase: Phase 3
Study type: Interventional

This study evaluated the efficacy and safety of two trough-ranges of everolimus given as adjunctive therapy in patients with tuberous sclerosis complex (TSC) who had refractory partial-onset seizures. The study consisted of 4 phases for each patient Baseline phase:[From Screening Week -8 (V1) to randomization visit at Week 0 (V2)], Core phase [from randomization at Week 0 (V2) to Week 18 (V11)], Extension phase [from Week 18 (V11) until 48 weeks after the last patient had completed the core phase] and Post Extension phase [from end of Extension phase to end of study].

NCT ID: NCT01713608 Completed - Malaria Clinical Trials

A Dose-escalation Study to Investigate Safety and Toleration of OZ439

Start date: November 2012
Phase: Phase 1
Study type: Interventional

A randomised, placebo-controlled, dose-escalation study to investigate safety and toleration of OZ439 OD for 3 days to healthy male and female volunteers. The study aims: - To determine the safety and tolerability of ascending doses of OZ439 OD for three days. - To assess pharmacokinetic parameters of ascending doses of OZ439 given OD. - To identify the maximum tolerated dose of OZ439 administered.

NCT ID: NCT01713426 Completed - Clinical trials for Postherpetic Neuralgia (PHN)

A Study to Compare QUTENZA With Pregabalin for the Treatment of Peripheral Neuropathic Pain (PNP) After 8 Weeks of Treatment

ELEVATE
Start date: July 11, 2012
Phase: Phase 4
Study type: Interventional

This study is comparing the efficacy and tolerability of Qutenza with that of pregabalin in patients suffering from peripheral neuropathic pain. Treatment allocation will be to one of these treatments and the duration of the study will be about 10 weeks (assuming that from screening to treatment allocation takes 2 weeks). Participants will be asked to complete questionnaires about various aspects relating to their condition throughout the study. This study will include subjects suffering from Postherpetic Neuralgia, Peripheral Nerve Injury or Non Diabetic peripheral polyneuropathy.