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NCT ID: NCT04127890 Completed - Diabetes Mellitus Clinical Trials

ELO Water In Diabetes Care For Enhancement Of Blood Sugar Control

EDEN
Start date: March 7, 2017
Phase: N/A
Study type: Interventional

This double-blinded, randomised and controlled trial evaluates the efficacy of oxygen-enriched ELO drinking water as an adjuvant modality in diabetes care for enhancement of glycemic control in patients with Type 2 diabetes mellitus. Adults with type 2 diabetes will be randomized to drink 1.5 L of either ELO water or normal drinking water for 24 weeks. The primary outcome is improvement in glycaemic control.

NCT ID: NCT04124978 Completed - Clinical trials for Obstructive Sleep Apnea

Evaluation of Prefabricated Adjustable Thermoplastic Mandibular Advancement Devices for Obstructive Sleep Apnoea

Start date: July 21, 2017
Phase: N/A
Study type: Interventional

Use of mandibular advancement devices(MADs) in the treatment of Obstructive Sleep Apnea is established, however this is hampered by high costs, long wait times and non-assured success in the local Asian setting. There are few studies which look at the use of prefabricated thermoplastic mandibular devices with a titratable component and its efficacy. In addition, it is direct-to-consumer and an economical option, thus there may be a role in the use of such devices to better select patients who may benefit and are thinking of using MADs. The investigators aim to evaluate the effectiveness of the use of Prefabricated adjustable thermoplastic mandibular advancement devices(PAT-MADs)(MyTAP) in the treatment of OSA and its role for predicting treatment success in an Asian population.

NCT ID: NCT04124120 Recruiting - Clinical trials for Coronary Artery Disease

Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women

ROMA:Women
Start date: April 17, 2023
Phase: N/A
Study type: Interventional

The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grfating (SAG). The specific aims of ROMA:Women are: Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grfating (CABG). The investigators will compare major adverse cardiac and cerebrovascular events (death, stroke, non-procedural myocardial infarction, repeat revascularization, and hospital readmission for acute coronary syndrome or heart failure) in a cohort of 2,000 women randomized 1:1 to MAG or SAG (690 from the parent ROMA trial + 1,310 from ROMA:Women). Differences by important clinical and surgical subgroups (patients younger or older than 70 years, diabetics, racial and ethnic minorities, on vs off pump CABG, type of arterial grafts used) will also be evaluated. The women enrolled in the ongoing ROMA trial (anticipated to be approximately 690) will be included in ROMA:Women, increasing efficiency and reducing enrollment time. Hypothesis 1.0. MAG will reduce the incidence of major adverse cardiac and cerebrovascular events. Hypothesis 1.1. The improvement with MAG will be consistent across key subgroups. Aim 2: Determine the impact of MAG vs SAG on generic and disease-specific QOL, physical and mental health symptoms in women undergoing CABG. The investigators will compare generic (SF-12, EQ-5D) and disease-specific (Seattle Angina Questionnaire) QOL and physical and mental health symptoms (PROMIS-29) in a sub-cohort of 500 women randomized 1:1 to MAG or SAG (including those enrolled in ROMA:QOL). Differences by important subgroups (as defined above) will also be evaluated. Hypothesis 2.0. MAG will improve generic and disease-specific QOL compared to SAG. Hypothesis 2.1. MAG will improve physical and mental health symptoms compared to SAG. Hypothesis 2.2. The improvement with MAG will be consistent across key subgroups.

NCT ID: NCT04119999 Completed - Clinical trials for Obstructive Sleep Apnea

A Cardiosleep Research Program on Obstructive Sleep Apnea, Blood Pressure Control and Maladaptive Myocardial Remodeling

CRESCENT
Start date: October 16, 2019
Phase: N/A
Study type: Interventional

The objective of this proposal is to evaluate whether mandibular advancement device (MAD) is non-inferior to continuous positive airway pressure (CPAP) in the treatment of obstructive sleep apnea (OSA) and blood pressure reduction. OSA and hypertension are highly prevalent disorders with profound impacts on health. Apart from improving quality of-life, an effective OSA treatment could improve cardiovascular risk partly through blood pressure reduction, particularly in patients with high cardiovascular risk in whom blood pressure control is often suboptimal. Although CPAP is useful, the high non-acceptance and non-adherence preclude its widespread use. East Asians have a restrictive craniofacial phenotype that predisposes them to OSA and the associated cardiovascular stress. CPAP, while considered the first-line therapy for OSA, has failed to improve cardiovascular outcomes in randomized trials till date because it is poorly tolerated. MADs are oral appliances that correct the restrictive craniofacial phenotype present in East Asians by protruding the lower jaw to reduce upper airway collapsibility. MADs are better tolerated than CPAP, and this may be an important determinant of the overall effectiveness in treating OSA, and thus ameliorating the downstream adverse health outcomes. We hypothesize that MADs are non-inferior to CPAP in treating OSA and reducing cardiovascular risk by blood pressure reduction in East Asians. We will recruit East Asian subjects with hypertension and high cardiovascular risk for polysomnography. Patients diagnosed with OSA (n=220) will be randomized to MAD or CPAP groups in a 1:1 ratio for a treatment duration of 6 months. The primary endpoint is the 24-hour mean blood pressure as determined by ambulatory monitoring. The secondary endpoints include sleep-time systolic BP, target blood pressure, cardiovascular biomarkers, and myocardial remodeling. Association between OSA and silent paroxysmal atrial fibrillation will also be determined. If MADs are shown to be effective, the next step is to evaluate our novel device- drug-eluting MAD that the team is developing.

NCT ID: NCT04118114 Recruiting - Clinical trials for Hepatocellular Carcinoma

Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors

Start date: September 3, 2019
Phase: Phase 2
Study type: Interventional

This is a Phase II, open-label, single dose level study of PRL3-ZUMAB monotherapy in patients with advanced solid tumours that have failed standard therapy. Approximately 30 patients will be recruited with ~10 gastric cancers and ~10 hepatocellular carcinomas. Patients who have received at least 1 dose of PRL3-ZUMAB will be evaluable for toxicity and efficacy. PRL3-ZUMAB will be given IV every 2 weeks for up to 12 infusions in the absence of unmanageable toxicities or disease progression. Patients who are benefitting from the treatment may continue on PRL3-ZUMAB beyond 12 infusions with the agreement of the study drug provider. PRL3-ZUMAB at the RP2D in tumour types enriched for known PRL-3 expression for efficacy and tolerability will be evaluated. There will also be in depth molecular profiling of tissues in patients who have an objective response or prolonged disease stabilization to identify predictive/selection biomarkers as well as evaluation of the oncogenic signaling modulation and immunomodulation by PRL3-ZUMAB and its potential for future combination with other targeted therapies or immunotherapy.

NCT ID: NCT04115657 Completed - Obese Clinical Trials

The Effect of Different Starches of Boba Pearls and Sugar Substitutes Used in Milk Tea on Glycaemia, Insulinaemia and Appetite Control (Pearl Study)

Start date: May 2, 2019
Phase: N/A
Study type: Interventional

The first objective is to investigate the effect of boba pearls made from different starches on glycaemia, insulinaemia and appetite control. The second objective is to investigate the effects of various sugar blends of sucrose with sugar substitutes in milk tea on glycaemia, insulinaemia and appetite control.

NCT ID: NCT04115592 Completed - Clinical trials for Diabetes Mellitus, Type 2

The Effect of Different States of Lipid in Food on Glycaemia, Lipaemia and Insulinaemia.

Start date: February 20, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to investigate if the application of lipid in various form (i.e. liquid and solid) affects glycaemia, lipaemia and insulinaemia. In addition, this study aims to test the lipidemic effects of the use of vegetable oil as a substitute in the application for making chocolate confectionery.

NCT ID: NCT04115579 Completed - Clinical trials for Diabetes Mellitus, Type 2

The Impact of Low Glycaemic Index (GI) Biscuits on Postprandial Glycaemia Using the Continuous Glucose Monitoring System (CGMS™) (Biscuit Study (BIS) Study)

Start date: February 20, 2019
Phase: N/A
Study type: Interventional

To investigate whether low glycaemic index (GI) biscuits have the greatest impact on the post-meal glucose response and on the overall 24 hour blood glucose control, using the continuous glucose monitoring system (CGMS™)

NCT ID: NCT04112576 Completed - Clinical trials for Heart Failure, Systolic

Physiological Signals, Activity and Posture for Surface Mounted Insertable Cardiac Monitor in Heart Failure Study

HAPI-HF
Start date: July 23, 2020
Phase:
Study type: Observational

To characterize the physiological signals collected from a Wearable Cardiac Monitor (WCM) prototype device in subjects with heart failure and preserved ejection fraction (HFpEF) and compare against signals from subjects with heart failure and reduced ejection fraction (HFrEF). To evaluate the relationship of physiological signals measured from a wearable cardiac monitor (WCM) prototype device with ECHO measures of systolic and diastolic function

NCT ID: NCT04109066 Completed - Breast Cancer Clinical Trials

Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer

CheckMate 7FL
Start date: November 20, 2019
Phase: Phase 3
Study type: Interventional

A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.