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NCT ID: NCT01892436 Completed - Psoriatic Arthritis Clinical Trials

Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis

FUTURE 1 ext
Start date: September 30, 2013
Phase: Phase 3
Study type: Interventional

This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.

NCT ID: NCT01892176 Completed - Parkinson Disease Clinical Trials

Effects of High-dose Coenzyme Q10 on Biomarkers of Oxidative Damage and Clinical Outcome in Parkinson Disease

Start date: June 2012
Phase: Phase 2/Phase 3
Study type: Interventional

The investigators hypothesise that measuring biomarkers of oxidative damage could better inform investigators on the potential merits (and pitfalls) of CoQ10 supplementation in PD subjects.

NCT ID: NCT01890434 Completed - Clinical trials for Coronary Artery Disease

Gadobutrol / Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)

GadaCAD 2
Start date: August 26, 2013
Phase: Phase 3
Study type: Interventional

Subjects being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study. The duration for a subject in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required. The primary objective of this study is to demonstrate that sensitivity and specificity of gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) exceed pre-specified minimum performance thresholds of 60% and 55%, respectively, and to show superior sensitivity over unenhanced wall motion CMRI at vasodilator rest/stress for the detection of significant CAD. The CMR images acquired with a uniform imaging acquisition software will be evaluated either against the results from routine clinical Coronary Angiography (CA) or Computed Tomography Angiography (CTA), which are the standard of reference. CMRI and CA/CTA images will be collected for an independent image review (blinded read).

NCT ID: NCT01889628 Completed - Diabetes Clinical Trials

Study to Determine Ethnic Differences in the Glycaemic Response to Nutritional Formula Drinks

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

Nutritional formula drinks are widely consumed in Asia especially by those having chronic illnesses such as diabetes. Therefore, gauging the impact of nutritional formulas on blood glucose levels is very important. Asia is home to three predominant ethnic groups- Chinese, Malay and Indians. It is still unknown if the blood glucose response to nutritional formulas differs between ethnic groups. Therefore the aim of this study is to observe if there are ethnic differences in the blood glucose response to nutritional formula drinks.

NCT ID: NCT01888432 Completed - Clinical trials for Liver Transplantation

Efficacy and Safety of Everolimus in Liver Transplant Recipients of Living Donor Liver Transplants

Start date: September 25, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this trial was to demonstrate the efficacy and safety of everolimus in combination with reduced tacrolimus, compared to tacrolimus control, in living donor liver transplant recipients.

NCT ID: NCT01887951 Completed - Acute Pain Clinical Trials

Penthrox Versus Tramadol for SCDF

PENTRA
Start date: February 2014
Phase: Phase 4
Study type: Interventional

Introduction Current practice in Singapore Emergency Ambulance Service (EAS) includes the use of analgesia delivered via inhalation Enthanox (Nitrous Oxide). However there are difficulties administering Enthanox on-scene due to the added weight of carrying bulky cylinder tanks. It is common for a delay in administration of analgesia. Inhaled methoxyflurane (Penthrox) is a potential agent for early administration of analgesia by Singapore Civil Defense Force (SCDF) EAS. It is extensively used in the pre-hospital setting in Australia. However data on its use as an analgesic agent in general are limited and there are few published controlled trials of methoxyflurane in an analgesic role. Intramuscular (IM) tramadol is a common medication used in the hospital setting for analgesia. It is well proven, simple to deliver and is not a controlled drug. Aim To compare Penthrox and Tramadol in the treatment of acute pain in patients transported by the SCDF EAS. Methodology The trial will recruit 400 eligible patients over 1 year (200 Penthrox and 200 tramadol). Patients managed by SCDF EAS for treatment of acute pain and who meet the eligibility criteria will be recruited into the study. Half of SCDF's 30 ambulances (15 ambulances), will be randomly assigned, equipped and trained to carry the new medication (Penthrox). The other half (15 ambulances), will be trained and equipped with tramadol. Allocation will be on a per station level. After 6 months, they will cross over to Penthrox and tramadol respectively. All paramedics will be trained to use both medications, pain scales and Ramsey scores, and will record patient's pain, sedation scores and patient satisfaction as part of routine clinical practice. All patients will be followed up by a review of their Emergency Department and hospital records for any medication related adverse effects. Hypothesis The investigators hypothesize that in patients with acute pain (pain score ≥3), presenting to the ambulance service with musculo-skeletal trauma (limbs or back); pain relief by inhaled methoxyflurane will be equivalent to IM tramadol, as assessed by Visual Analogue Scale (VAS) at 5, 10, 15 and 20 min after start of the study treatments.

NCT ID: NCT01887912 Terminated - Clinical trials for Clostridium Difficile Infection

Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection

Start date: July 30, 2013
Phase: Phase 3
Study type: Interventional

The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need. Primary objective: - To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult participants aged >= 50 years who are at risk for CDI and have received at least 1 injection. Secondary Objectives: Efficacy: - To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections administered at 0, 7, and 30 days. - To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of at least 2 injections. Immunogenicity: - To describe the immunogenicity to toxin A and toxin B at specific time points in a subset of participant and in participants with CDI at Day 0 and Day 60. Safety: - To describe the safety profile of all participants who received at least 1 injection.

NCT ID: NCT01883011 Terminated - Clinical trials for Acute Ischaemic Middle Cerebral Artery Stroke

A Study to Evaluate the Efficacy and Safety of Piracetam on Aphasia After Acute Ischemic Cerebral Artery Stroke

Start date: August 1998
Phase: Phase 4
Study type: Interventional

The aim of this study was to confirm the efficacy of piracetam after 12 weeks of treatment on the aphasic status of subjects suffering from aphasia after acute ischemic middle cerebral artery stroke and having received their medication within 7 h post-stroke onset.

NCT ID: NCT01881217 Completed - Neoplasms Clinical Trials

First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors

Start date: June 28, 2013
Phase: Phase 1
Study type: Interventional

An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety, tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of BAY1179470 in subjects with advanced, refractory solid tumors

NCT ID: NCT01880294 Completed - Constipation Clinical Trials

A Study to Assess Different Diagnostic Criteria of Chronic Constipation in Asia

CONSIST
Start date: March 2013
Phase: Phase 4
Study type: Observational

The purpose of the study is to evaluate the differences or similarities in the results obtained with two different scoring systems for chronic constipation in Asian participants consulting in gastroenterology clinics (the Asian Neurogastro-enterology and Motility Association (ANMA) chronic constipation (CC) diagnostic tool (diagnosis questionnaire) and the ROME III diagnosis criteria (western gold standard).