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NCT ID: NCT03400943 Not yet recruiting - Leiomyoma Clinical Trials

Assess Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids (ASTEROID 3)

Start date: February 20, 2018
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to show superiority in the treatment of HMB of vilaprisan in subjects with uterine fibroids compared to placebo. The secondary objectives of this study are to additionally evaluate the efficacy and safety of vilaprisan in subjects with uterine fibroids.

NCT ID: NCT03399357 Recruiting - Diabetes Mellitus Clinical Trials

Evaluation of Metabolic Predictors of Influenza Vaccine Immune Response in the Singapore Elderly Population - the DYNAMIC Trial

Start date: May 31, 2017
Phase: N/A
Study type: Observational

The trial aims to evaluate role of metabolic factors including systemic 25-OH D and diabetes in the adaptive immune response (haemagluttination inhibition titer) to influenza vaccine in the elderly. The influenza vaccine administered in this study will be licensed trivalent inactivated influenza vaccine. Elderly who are age above 65 including those with co-morbidities such as diabetes mellitus will be included. The study has its inclusion and exclusion criteria to determine eligibility for participation.

NCT ID: NCT03395938 Active, not recruiting - Colorectal Cancer Clinical Trials

Uncovering the Barriers of Colorectal Cancer Screening Amongst Siblings of Colorectal Cancer Patients.

Start date: May 1, 2017
Phase: N/A
Study type: Interventional

To determine amongst siblings of colorectal cancer patients:1. The knowledge, perception and barriers towards screening colonoscopy. 2. The current screening colonoscopy adoption rate. 3. If patients would engage them through active engagement by healthcare providers in a bid to improve their receptiveness towards and partake in colorectal cancer screening. 4. The method(s) that Colorectal cancer patients adopt to communicate with them. 5. If tailored interventions addressing logistical, psychological and cost barriers could increase the adoption of screening colonoscopy.

NCT ID: NCT03394417 Not yet recruiting - Clinical trials for Head and Neck Cancers

StrataXRT vs Standard Clinical Practice for the Prevention of Acute Dermatitis in Head and Neck Cancers Patients

Start date: February 2018
Phase: N/A
Study type: Interventional

Clinical significance and current evidence: Radiation dermatitis occurs commonly in patients receiving chemoradiation for nasopharyngeal cancer; 50 to 60% develop grade 2 or higher dermatitis. This can result in significant morbidity, reduced aesthetic appearance, decrease in quality of life and delays in treatment. Current literature does not conclusively support the use of one agent over another for prevention of radiation dermatitis. The choice of agents used in clinical practice is highly variable, with aqueous agents being one of the commonest. Specific Aims: The aim of this study is to evaluate if the investigational product (StrataXRT), a silicone-based gel, is superior to standard clinical practice in prevention of grade 2 or higher acute dermatitis in patients receiving chemoradiation for nasopharyngeal carcinoma. Trial Design: The study will be conducted using a prospective, double-blind randomized control trial in 2 institutions. Each arm will receive standard radiation to a total dose of 70 Gray (Gy) with concurrent chemotherapy. The primary objective is to compare the prevention of dermatitis and the primary endpoint is reached when grade 2 or higher dermatitis according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 scale occurs. Secondary objectives will be evaluation of the time to onset of dermatitis, the time to complete recovery from dermatitis and the degree of pain. Assessment of the patient's skin will be done at baseline, weekly during treatment, 1 week post treatment and unless the skin has resolved to baseline then every week up until 6 weeks post-treatment, which will mark the end of follow-up. The safety end-point is reached when grade 4 dermatitis occurs. Hypothesis and statistics: The investigators aim to demonstrate a 30% reduction in the incidence of grade 2 or higher dermatitis with StrataXRT. Using a 2-sided test at significance level 0.05 to detect the difference with a power of 80%, the investigators envisage a recruitment of 100-150 patients in total. The study duration is estimated to be 2 years.

NCT ID: NCT03386721 Not yet recruiting - Solid Tumors Clinical Trials

Study to Evaluate the Therapeutic Activity of RO6874281 as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors

Start date: January 25, 2018
Phase: Phase 2
Study type: Interventional

This is an open-label, multicenter, Phase II study to evaluate the antitumor activity of RO6874281 in combination with atezolizumab in participants with advanced and/or metastatic solid tumors.

NCT ID: NCT03382548 Not yet recruiting - Clinical trials for Ventilator Associated Pneumonia

Defining Antibiotic Treatment Duration for Ventilator - Associated Lung Infection

REGARD_VAP
Start date: June 2018
Phase: Phase 3
Study type: Interventional

Intensive care units (ICUs), with high antibiotic consumption, are epicentres of antimicrobial resistance (AMR). Ventilator associated pneumonia (VAP) is the commonest hospital-acquired infection (HAI) in ICUs and is associated with a high morbidity and mortality in these vulnerable patients despite antibiotic therapy. No well-designed clinical trials studying antibiotic duration for VAP caused by predominantly non-fermenting Gram-negative bacteria have been conducted to date. Shortening antibiotic duration has the potential to improve individual patient outcomes and indirectly benefit other patients by reducing the selection pressure for multidrug resistant (MDR) bacteria within the ICU. This study aims to show non-inferiority of short antibiotic treatment duration (7 days or less) versus long antibiotic therapy (8 days or more) for VAP. Patients who have been ventilated for more than 48 hours will be screened daily for signs and symptoms of VAP according to the US Centers for Disease Control and Prevention VAP criteria. Recruited patients will be reviewed daily for clinical signs of stability including temperature <38°C for 48 hours, systolic blood pressure >90mmHg without inotropes. Recruited patients will be randomised once they fulfill these clinical criteria of stability. In the intervention arm, antibiotics should be stopped within 7 days once the above criteria are fulfilled. In the control arm, antibiotics should be at least 7 days with the exact duration decided by the managing physicians. The primary outcome of the study is a combined endpoint of mortality and VAP recurrence at day 60 of recruitment. The study hypothesis is that a shorter duration of treatment for VAP (7 days or less depending on clinical response) is noninferior to a longer duration (8 days or more). The secondary outcomes of the study include clinical parameters such as rate of acquisition of MDRO hospital-acquired infections, duration of ventilation and hospitalization and days of antibiotics use. The study team will also characterise the microbiome changes in study participants according to the type and duration of antibiotics. MDROs collected will undergo whole genome sequencing for transmission dynamics study. The study is a multinational multicenter study involving hospitals in Asia.

NCT ID: NCT03382223 Not yet recruiting - Advanced Dementia Clinical Trials

Panel Study Investigating Status of Cognitively Impaired Elderly in Singapore

PISCES
Start date: January 1, 2018
Phase: N/A
Study type: Observational

Dementia affects 10% of the elderly population in Singapore. However, there is a lack of systematic information regarding end of life (EOL) care received by patients dying with severe dementia (PDSD), PDSD's EOL direct and indirect costs and caregiver burden. This study, a first of-its-kind prospective cohort study in Singapore will assess the EOL care received by PDSD and PDSD's caregivers, EOL medical and social care costs of severe dementia and caregiver burden; and will develop a risk score to predict 6-month mortality for PDSD. The investigators will accomplish this by surveying caregivers of PDSD every 4 months till the patient passes away and 6 weeks and 6 months after patient's death during caregiver bereavement. The investigators will also extract and match patient medical and billing data with survey data for comprehensive assessment of care costs. Key outcomes achieved by this study will be improved understanding of PDSD's EOL care, EOL care costs, and caregiver burden and bereavement. The systematic data collected will also lead to predicting 6 month mortality for community dwelling PDSD with greater accuracy compared to existing tools. Positive implications from this study will be improved early decision making by caregivers regarding EOL care and physician referrals for palliative care services; and a better understanding of EOL care for PDSD and PDSD's caregivers that will lead to cross-sector collaborations to improve delivery of palliative care to PDSD. In this way this proposal is highly responsive to the grant call which focuses on early decision making and cross sector palliative care delivery among non-cancer patients. In the long term, this study will improve clinical and public health policy and has the potential to be the foundation for future initiatives for dementia care and improved social and medical infrastructure planning.

NCT ID: NCT03378115 Active, not recruiting - Energy Expenditure Clinical Trials

Energy Cost of Posture Maintenance, Ethnic Differences and the Influence of Metabolic State

Start date: May 25, 2017
Phase: N/A
Study type: Observational

The purpose of this study is to determine the magnitude of changes in energy expenditure and respiratory quotient (RQ) during sitting and standing in Asian men.

NCT ID: NCT03376490 Completed - Clinical trials for Vitamin D Deficiency

Study of the Association of Muscle Strength, Balance and Other Factors With Vitamin Levels Among Elderly Diabetics

Start date: January 1, 2012
Phase: N/A
Study type: Observational

Vitamin B12 deficiency can cause severe problems with the blood, nerves, brain and psychological well-being. Ironically, our modern methods for the control of diabetes mellitus can actually contribute to vitamin B12 deficiency. This is because the diabetic medication "metformin", low-cholesterol diets lacking in meats (a natural source of vitamin B12) and the use of powerful anti-gastric medication can all reduce the natural absorption of vitamin B12 from the diet, especially in elderly people with diabetes. There is both a high prevalence of vitamin B12 deficiencies and falls among the elderly with type 2 diabetes mellitus and the investigators hypothesize that B12 deficiency contributes directly and significantly to falls in elderly diabetics through impaired muscle strength, gait and balance. This study therefore proposes to investigate the association between vitamin B12 deficiency and fall risk among diabetic elderly patients (older than 65 years) in the polyclinic setting by assessing muscle strength, balance and walking speed. The predictors of vitamin B12, folate, homocysteine and vitamin D levels will also be explored in this study. If the hypothesis is right, this would be of public health importance & can lead to further studies that can change the way we treat diabetes by reducing falls in our elderly diabetics through the screening for, prevention and treatment of B12 deficiency.

NCT ID: NCT03368417 Recruiting - Hypertension Clinical Trials

WIreless Monitoring and Financial Incentives for Uncontrolled HYpertension (WIFHY) Study

WIFHY
Start date: December 20, 2017
Phase: N/A
Study type: Interventional

Hypertension is a major risk factor for cardiovascular morbidity and mortality. Despite the risks of hypertension and availability of effective treatment, a substantial number of patients have uncontrolled Blood Pressure (BP). Systematic reviews have shown that Home Blood Pressure Monitoring (HBPM) produces modest improvements in BP control and that HBPM yields greater benefits when combined with other interventions such as remote titration change or adherence-enhancing strategies. The investigators propose a Wireless HBPM System comprising of a Wireless Home Blood Pressure Monitor and a Study Application that aims to: provide text messaging on BP advice and reminders on BP management based on BP readings; promote adherence to BP monitoring and adherence to medication; flag patients for counselling on medication adherence and remote titration (by doctor) during in-between visits; cut the response time in case of emergency; and skip polyclinic visits for well-managed patients. An additional arm will include the the addition of modest financial incentives for participants when they monitor their BP. This arm is subdivided into two sub-arms (Instant Reward and Health Capital) where patients are eligible to receive the same incentive amounts but framed differently. This study is novel in its comprehensive approach to patient disease self-management and remote provision of medical care, potentially reducing the burden on the health system and improving patient health outcomes.