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NCT ID: NCT06164951 Enrolling by invitation - Achondroplasia Clinical Trials

A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia

PROPEL3
Start date: November 10, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy and safety of infigratinib in children and adolescents with achondroplasia (ACH) who have completed at least 26 weeks of participation in the QED-sponsored study PROPEL (QBGJ398-001).

NCT ID: NCT05964933 Enrolling by invitation - Clinical trials for Pulpitis - Irreversible

Pulpotomy vs Root Canal Treatment for Teeth With Symptomatic Irreversible Pulpitis

Start date: July 11, 2023
Phase: N/A
Study type: Interventional

This study is a randomised controlled trial for complete pulpotomy as an alternative to root canal treatment for teeth with clinical diagnosis of symptomatic irreversible pulpitis (i.e. signs and symptoms indicative of irreversible pulpitis) conducted at the National University Centre for Oral Health Singapore (NUCOHS) Endodontic unit. Up to 70 teeth, 35 in each group, will be enrolled. Clinical and radiographic outcome data will be collected and analysed, and a parallel cost-effectiveness analysis will also be undertaken to examine the potential costs and benefits of pulpotomy. A process evaluation will also be conducted to assess the acceptability of the intervention to both dentists and patients, while exploring the barriers and enablers to implementation.

NCT ID: NCT05934422 Enrolling by invitation - Atopic Dermatitis Clinical Trials

NiPPeR Randomised Trial - Child Follow Up Study

NiPPeR Child
Start date: June 16, 2023
Phase: N/A
Study type: Interventional

There is an increasing focus on the need to optimise nutrition, lifestyle and metabolism of parents before and during pregnancy and of the infant after birth, but as yet there is limited understanding of the specific influences and of the underlying mechanisms. This study is a follow up of children from the NiPPeR trial of a nutritional drink enriched with micronutrients, myo-inositol and probiotics taken preconception and during pregnancy. In this setting we will examine the influence of parental nutrition, lifestyle and metabolism before and during pregnancy on child growth, development and well-being; ascertaining growth, adiposity, metabolism, neurobehavioural and health outcomes in the children, and characterising the underlying mechanisms. The data collected will allow identification of the contributions of parental and offspring characteristics, nutritional, lifestyle and medical factors, social and economic status, ethnicity, genetics, metabolism and microbes to promoting healthy growth, body composition and wellbeing in the children.

NCT ID: NCT05803226 Enrolling by invitation - Clinical trials for Mental Health Wellness 1

Slow Art Plus: A Single Session Art Gallery-based Intervention for Mental Health Promotion

SAP
Start date: July 14, 2022
Phase: N/A
Study type: Interventional

Utilizing a Participatory Action Research (PAR) paradigm, this 12-month study will adopt a mixed method Waitlist Randomized Control Trial (RCT) with a built-in acceptability and feasibility study to test the efficacy of Slow Art Plus in reducing stress and empowering self-care among 200 participants.

NCT ID: NCT05722145 Enrolling by invitation - Clinical trials for Coronary Artery Disease

Global Pretest Probability Study of Coronary Artery Disease

GPS-CAD
Start date: November 25, 2022
Phase:
Study type: Observational

The use of pre-test probability (PTP) and coronary artery calcium (CAC) scores is guideline-recommended in the evaluation of coronary artery disease (CAD) and stable chest pain. The utility of these scores is population dependent. Previous studies have predominantly been limited to Western populations, despite Asia forming 60% of the global population. However, Asian populations have differing coronary artery phenotypes and may therefore have different PTPs with varying implications for risk stratification. Known difference in CAC implications support a global approach. Hence, this study aims to evaluate a contemporary PTP in diverse real-world Asian, Western and other cohorts and to evaluate the incremental value of CAC in predicting CAD and events. Primarily, the study will compare population specific PTPs and CAC for prediction of coronary computed tomography angiography (CTA) CAD. This could be compared with existing guideline-recommended PTPs alone or with consideration of risk factors or CAC. The study will also evaluate the accuracy of the prediction of major adverse cardiovascular events (MACE) using PTP models, risk factors and/or CAC. Lastly, the study will investigate the accuracy of zero CAC and other minimal risk tools to de-risk cardiovascular disease (CVD) in various populations. The study will investigate multiple international cohorts of patients referred for noninvasive testing using coronary CTA or other non-invasive imaging modalities. Locally-calibrated PTP models in consideration of risk factors or CAC will be separately tailored to each different cohort, and will be evaluated.

NCT ID: NCT05374239 Enrolling by invitation - Stroke Clinical Trials

Embedding the Fugl-Meyer Assessment in Occupational Therapists' Routine Practice

Start date: July 6, 2022
Phase: N/A
Study type: Interventional

Background: Using outcome measures is emphasized in foundational training and clinical practice guidelines, but less than 50% of rehabilitation professionals consistently use outcome measures in practice. No studies have evaluated the barriers to routine outcome measurement in Singapore's healthcare settings nor identified effective implementation strategies to sustain the use of outcome measures in practice. Aims: To evaluate the effectiveness of a tailored multi-component implementation intervention effectiveness in improving the consistency of use of the Fugl-Meyer Assessment of Upper Extremity (FMA) among occupational therapists practicing in 4 hospitals in Singapore. Method: The project will use the Normalisation Process Theory as a framework and data collection sites will include Singapore General Hospital, Sengkang General Hospital, Outram Community Hospital, and Sengkang Community Hospital. The investigators will use a stepped-wedge randomised trial design. The study will begin with an initial period in which no hospitals are exposed to the intervention. Subsequently, at regular intervals, one hospital will cross from the control to the intervention. The investigators will continue this process until the intervention is introduced to all hospitals. The intervention will be fully implemented by the end of the trial, with all 4 hospitals receiving the multi-component intervention. Project Significance: This trial is part of a larger project that uses a theory-driven approach to systematically explore the embedding and integration of outcome measures in routine clinical care for rehabilitation professionals in Singapore (beyond initial implementation stages). Study findings will contribute to the scientific knowledge base of implementing outcome measures in clinical practice, improve patient care, and support future implementation projects on outcome measurement in different populations and healthcare settings.

NCT ID: NCT05217745 Enrolling by invitation - Clinical trials for Non-Alcoholic Fatty Liver Disease

MLCT Oil for Fatty Liver - PASS Trial

PASS
Start date: August 5, 2021
Phase: N/A
Study type: Interventional

The main objective of this randomised pilot study is to explore the relative efficacy of dietary MLCT oil versus LCT oil (corn oil) in augmenting therapy of overweight and obese NAFLD patients with at least a 1-stage reversal between F1 and F4.

NCT ID: NCT05049954 Enrolling by invitation - Obesity Clinical Trials

Weight Loss for a Healthier You Programme

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

In view of the research gap in the safety of traditional ketogenic diet, there is a need for a healthy alternative to the ketogenic diet that reduces the individual's propensity to adverse diet choices. Healthy guidelines to be adopted include a diet low in saturated fat, trans fat, and sugar, along with adequate fibre. Potentially with these guidelines in effect, the associated risks for CVD would be reduced. Therefore, this study will investigate the effect of a calorie-restricted healthy ketogenic diet versus a calorie-restricted low fat diet on weight loss and metabolic outcomes among individuals with obesity.

NCT ID: NCT04745702 Enrolling by invitation - Diabetes Clinical Trials

Food Based Intervention Rich in Plant Components to Improve Metabolic Health in Prediabetics (FBIP) Study

Start date: November 2, 2020
Phase: N/A
Study type: Interventional

The estimated prevalence of type 2 diabetes and prediabetes in Singapore will be approximately 20% and 25% respectively by the year 2035. Therefore, effective population based interventions are urgently warranted to halt this burden. Lifestyle intervention is the cornerstone of diabetes prevention and even remission. For example, dietary patterns such as the Mediterranean diet, Dietary Approaches to Stop Hypertension (DASH) diet etc. have all been shown to reduce risk of type 2 diabetes incidence. Therefore, given the successful utility of various dietary patterns, this randomized controlled trial will investigate the effectiveness of a food based dietary intervention, within an Asian dietary context, using legumes, low glycemic index (GI) starches (i.e., rice, noodles etc.), healthier vegetable oil blend as well as herbs and spices to improve various markers metabolic health, including glucose homeostasis in individuals with prediabetes.

NCT ID: NCT04381754 Enrolling by invitation - Clinical trials for Hemodialysis Access Failure

Use of Implanting the Biotronik Passeo-18 Lux Drug Coated Balloon to Treat Failing Haemodialysis Arteriovenous Fistulas and Grafts.

SEMPER FI
Start date: June 2020
Phase:
Study type: Observational [Patient Registry]

The most common problem with haemodialysis arteriovenous fistulas (AVF) and arterio-venous grafts (AVG) is stenosis, which can lead to inadequate dialysis, and eventual access thrombosis. Conventional plain old balloon angioplasty is associate with high recurrence rates of stenosis and repeated interventions. The advent of successful drug-eluting technology in the treatment of the coronary vascular bed and subsequent positive accumulating evidence in the peripheral arterial circulation has prompted the use of drug coated balloons (DCB) in the access fistula circuit for venous stenosis and in-stent restenosis. Recent studies suggest that DCBs may significantly reduce re-intervention rates on native and recurrent lesions. The restenosis process is in part or in whole the result of neo-intimal hyperplasia (NIH) and NIH is considered the main culprit in access circuit target lesion stenosis. NIH is the blood vessel's healing response to the barotrauma from the angioplasty process. A critical component of NIH is the cellular proliferative stage with mononuclear leucocytes identified as the primary inflammatory cell type involved. The rationale for drug elution is to block the NIH response with an anti-metabolite such as paclitaxel. It is important to emphasize that the role of drug elution in the treatment of vascular stenosis is not to obtain a good haemodynamic and luminal result but to preserve a good result obtained during POBA from later restenosis due to NIH and minimise reinterventions and readmissions to hospital for what is a frail population of patients. A meta-analysis performed by Khawaja et al. seemed to suggest that DCBs conferred some benefit in terms of improving target lesion primary patency (TLPP) in AVFs. An updated meta-analysis performed by our own institution recently showed that DCB appears to be a better and safe alternative to conventional balloon angioplasty (CBA) in treating patients with HD stenosis based on 6- and 12-months primary patency and increased intervention free period. The Passeo-18 Lux (Biotronik Asia Pacific Pte Ltd (Singapore)) drug-coated balloon (DCB) is packaged with a low dose of paclitaxel. Recent studies have shown that low dose coating of paclitaxel with this DCB is useful for preventing restenosis, decrease lumen loss and target lesion revascularization in the peripheral vasculature6 but has not been tested in the dialysis access circuit.