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NCT ID: NCT02668653 Completed - Leukemia Clinical Trials

Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)

QuANTUM-First
Start date: September 1, 2016
Phase: Phase 3
Study type: Interventional

Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML). Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy.

NCT ID: NCT02666014 Completed - Clinical trials for Postoperative Nausea and Vomiting

Sugammadex Versus Neostigmine for Postoperative Nausea and Vomiting After Laparoscopic Gynaecological Surgery

Start date: June 2015
Phase: Phase 3
Study type: Interventional

The laparoscopic technique is commonly employed for abdominal gynaecological surgery in women. Postoperative nausea and vomiting (PONV) may occur in 30% of women undergoing gynaecological surgery. In patients with multiple risk factors for nausea and vomiting, the incidence is up to 80%. PONV has a significant negative effect on patient satisfaction after anesthesia and is one of the most common causes for unexpected hospital admissions in day-surgery. Sugammadex and Neostigmine are both drugs that are used to reverse the effect of muscle relaxation producing drugs that are commonly used during surgery. Neostigmine has been the drug of common use for this purpose, but PONV is reported with its usage. With this research we intend to determine whether the trial drug Sugammadex would reduce the incidence of PONV in high-risk women after undergoing laparoscopic gynaecological surgery when compared to Neostigmine.

NCT ID: NCT02663037 Completed - Health Status Clinical Trials

Simple Segmentation Tool to Understand Elderly Health Status and Needs

Start date: May 2016
Phase: N/A
Study type: Observational

Background: The delivery of targeted, patient-centered care for a population with heterogeneous healthcare needs while moderating costs is a key challenge in healthcare. Segmentation of patient populations based on clinically distinguishing features and social healthcare needs is currently a promising method for informing the organization of healthcare supply to these needs. Aims: In this prospective cohort study, the investigators aim to assess the Simple Segmenting Tool (SST) as a method of patient population segmentation in terms of its inter-rater reliability, as well as convergent and predictive validity. We will also revise the tool based on feedback from the validity studies should the need arises. Hypothesis: The investigators hypothesize that the SST is able to exhibit good inter-rater reliability, convergent validity and predictive validity for adverse events. Methodology: Non-critical patients aged 55 and above presenting to the Emergency Department will be screened with the SST. Raters will be paired in order to assess inter-rater reliability. To test convergent validity, the LACE, SF-12, and Clinical Frailty Scale (CFS) will also be used. Finally, predictive validity will be assessed by evaluating adverse event rates of patients in each SST category. Adverse events include all-cause mortality, length of hospital stay, emergency department visit and unplanned hospital readmission. Significance to Health Services Delivery: This study will provide evidence supporting the use of a standardized tool for evaluating the medical and social needs of patients at various sites of care. Following which, tailored packages of healthcare services can then be delivered in order to meet these needs.

NCT ID: NCT02657161 Completed - Rabies Clinical Trials

Safety and Efficacy of a PIKA Rabies Vaccine Containing the PIKA Adjuvant

Start date: February 2015
Phase: Phase 1
Study type: Interventional

Phase I clinical study for an investigational PIKA (Polyinosinic-Polycytidylic Acid Based Adjuvant) rabies vaccine comprising Inactivated and Purified Rabies Virus (IPRV) and the PIKA adjuvant. The primary objective of the study was to assess the clinical safety of the vaccine composition in healthy adult volunteers. The secondary objective was to evaluate the vaccine's efficacy based on an accelerated vaccine regimen.

NCT ID: NCT02655874 Completed - Influenza, Human Clinical Trials

Tropical Influenza Control Strategies for the Elderly

TROPICS1
Start date: May 2016
Phase: Phase 4
Study type: Interventional

TROPICS1 is a randomized, observer-blind, active comparator-controlled, single-center, Phase IV trial in 200 participants aged ≥65 years. The control group will receive a standard dose licensed trivalent inactivated influenza vaccine at day 1, and an active-comparator (Tetanus-diphtheria-pertussis vaccine) at day 180. Participants in the experimental group will receive the same influenza vaccine at day 1 and day 180. Endpoints are immunological, and include measures of haemagglutination-inhibition (HI) titres, micro-neutralisation titres and cell-mediated immunity at 4 time points after the initial vaccination up to Day 360. The primary hypothesis is that participants receiving an influenza booster at day 180 will achieve superior influenza seroprotection (HI titre ≥1:40) at day 208, compared to controls. The World Health Organization (WHO) estimates the global annual burden from seasonal influenza as 1 billion infections, with 3-5 million severe cases and 300,000-500,000 deaths. The pattern and impact of these infections varies considerably with climate. In temperate countries, influenza epidemics characteristically occur during the cold winter months, while in sub-tropical countries, they coincide with the rainy seasons. Closer to the equator, influenza virus activity is more complex. In Singapore, biannual epidemics are usual, but with continuous transmission year-round. Bi-annual epidemics, tri-annual epidemics and year round virus activity have also been described in other tropical countries, from Indonesia and Malaysia to Peru and Mexico. There is no published data reporting year-round influenza vaccine effectiveness in the elderly from countries with continuous influenza virus activity. Despite numerous studies worldwide exploring the HI antibody response to influenza vaccination, the majority of these do not continue follow up beyond seroconversion (21-28 days). However, of the few available, HI antibody titres declined following influenza vaccination in the elderly, such that within 6-12 months geometric mean titres approached pre-vaccination levels. With biannual epidemics and year-round transmission in tropical regions, year-round seroprotection may be important to reduce influenza infections in this environment. A six-monthly vaccination cycle would correspond with the decline in vaccine-induced seroprotection in the elderly, and the 6-monthly periodicity of outbreaks in Singapore and other tropical countries.

NCT ID: NCT02652364 Completed - Shock Clinical Trials

Strong Ion Gap as Prognostic Indicator for Adult Patients Admitted With Shock to the Intensive Care Units

Start date: October 2015
Phase:
Study type: Observational

This study evaluates if strong ion gap on admission or 24 hours after admission to critical care unit can predict 28 day outcome in patients admitted with shock due to any cause

NCT ID: NCT02636946 Completed - Glaucoma Clinical Trials

A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

Start date: February 24, 2016
Phase: Phase 3
Study type: Interventional

This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in participants with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).

NCT ID: NCT02636361 Completed - Healthy Clinical Trials

A Study of Various Formulations of LY900014 in Healthy Participants

Start date: December 2015
Phase: Phase 1
Study type: Interventional

This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the different formulations of LY900014. This study will determine how the different formulations, when injected under the skin, will affect the blood sugar levels in the body, and how safe it is.

NCT ID: NCT02622334 Completed - Glaucoma Clinical Trials

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5093151 in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).

Start date: December 29, 2015
Phase: Phase 1
Study type: Interventional

The purpose of the study is to assess the safety, tolerability, and IOP effects of RO5093151 following 7 days of topical ocular treatment in patients with primary open angle glaucoma or ocular hypertension.

NCT ID: NCT02620215 Completed - Pregnancy Clinical Trials

Cervical Ripening Balloon in Induction of Labour at Term

CRBII
Start date: November 2015
Phase: Phase 4
Study type: Interventional

About 1 in 6 deliveries in KKH are induced with prostaglandins. Inpatient induction can be a lengthy process especially when cervical priming is required. Although mechanical method of induction of labour (IOL) is established, its use in Singapore is uncommon. Systematic reviews comparing mechanical method against pharmacological and surgical IOL showed that mechanical method has similar efficacy with lower risk profile. As IOL is a common obstetric procedure, a revisit on the techniques is warranted. A multi-centre randomised controlled trial concluded that both cervical ripening balloon and prostaglandin are effective and complementary methods for IOL in uncomplicated singleton pregnancies, but did not examined the effects of pain. The investigators propose to evaluate the adverse events in the 12 hours after CRB or 1st prostaglandin insertion, its efficiency in term singleton IOL in Singapore context and test the acceptability of women in Singapore in using the CRB as an alternative method of induction of labour while using a non-incremental balloon filling regime. Currently, there is no efficient method of induction that can be used safely in an outpatient setting. Through this study, the investigators hope to show that there are no major adverse events in the 12h after patients are induced with CRB, this potentially supports outpatient IOL with CRB which can reduce hospitalisation and medical costs. A non-incremental balloon filling regime will decrease time delays and may increase patient satisfaction during its use in induction of labour.