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NCT ID: NCT03954743 Not yet recruiting - Clinical trials for Infections, Rotavirus

A Safety Study of 2 Formulations of GlaxoSmithKline Biologicals' (GSK's) Human Rotavirus (HRV) Vaccine in Healthy Infants of Age 6-12 Weeks

Start date: July 19, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to complete the total safety database size for GlaxoSmithKline Biologicals' (GSK's) human rotavirus (HRV) vaccine (ROTARIX) across the Porcine circovirus (PCV)-free development plan. This study will use a purposely selected lot for PCV-free liquid HRV vaccine that is in the upper range of the usual release potencies. The PCV-free liquid HRV vaccine lots used will be stored frozen in order to keep the titre stable until administration during the study. As the liquid formulation of ROTARIX is not licensed in the US, the lyophilized formulation of the vaccine will be used as a control in all phase III studies as part of the PCV-free development plan.

NCT ID: NCT03952910 Not yet recruiting - Chronic Pain Clinical Trials

An Online Pain Education Program for Working Adults

Start date: July 5, 2019
Phase: N/A
Study type: Interventional

Pain is popular among working population and it is a strong predictor of poor quality of life. In this study, an internet-delivered pain education program will be provided to working adults aims at helping patients equip with pain-related knowledge and useful skills and evaluate the effectiveness of the internet-delivered program. Participants will be recruited follow snowball sampling and will be randomly allocated to experimental group and control group by 1:1 ratio. The internet-delivered pain education will last for 4 weeks with one-month follow-up. Basic knowledge of pain, pharmacological and non-pharmacological treatment and related resources will be introduced in the program. Pain intensity, pain-related disability, anxiety, depression and self-efficacy will be measured in baseline post-treatment and at one-month follow-up. Acceptability and satisfaction to the program will also collected.

NCT ID: NCT03950102 Recruiting - Clinical trials for Hepatocellular Carcinoma

SBRT as Bridging Therapy for Hepatocellular Carcinoma Patients on Transplant Waitlist

Start date: July 1, 2015
Phase: N/A
Study type: Interventional

This is a single center, prospective study to assess the efficacy and safety of using stereotactic body radiation therapy (SBRT) as bridging treatment for hepatocellular carcinoma (HCC) patients on transplant waitlist.

NCT ID: NCT03946930 Recruiting - Alzheimer Disease Clinical Trials

IGF Binding Protein-2 Associated With Cognitive Decline

Start date: December 13, 2018
Phase:
Study type: Observational

There is lack of information on the risk factors of accelerated cognitive decline in older people with Alzheimer disease (AD). The extent of neurodegeneration and white matter disease has been reported to be important factors. In addition there may be biomarkers e.g. inflammatory cytokines that can contribute to cognitive decline. The impact of care arrangement and physical activity may also be important. Insulin signaling is impaired in Alzheimer disease (AD). Insulin and Insulin growth factor (IGF) pathways are closely related. IGF in the brain is in turn modulated especially by IGF binding protein -2. Higher plasma IGF binding protein -2 was associated with brain atrophy in older people. We therefore propose to perform a cohort study to test the hypothesis that higher plasma IGF binding protein-2 is independently associated with greater cognitive decline in older people with AD. This will be based on an on-going AD registry which was designed to identify genetic biomarkers for AD. Detailed neurocognitive tests and lifestyle information are available. In addition, volumetric MRI brain scans were performed in all AD subjects. The hypothesis is that MRI brain volumes, serum biomarkers, physical activity, physical functioning are independently associated with cognitive decline in older people with AD. The objective is to identify risk factors of accelerated cognitive decline so that preventive measures can be designed to delay dependency in AD.

NCT ID: NCT03943147 Recruiting - Lupus Nephritis Clinical Trials

An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis

Start date: April 19, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of BMS-986165 compared with placebo with regard to measures of kidney function in participants with lupus nephritis (LN).

NCT ID: NCT03941886 Not yet recruiting - Pre-Eclampsia Clinical Trials

Implementation of First-trimester Screening and preventiOn of pREeClAmpSia Trial (FORECAST)

FORECAST
Start date: June 2019
Phase: N/A
Study type: Interventional

This implementation study aims to evaluate the efficacy, acceptability, and safety of first-trimester screening and prevention for preterm-preeclampsia. It is a multicenter stepped wedge cluster randomized trial including maternity / diagnostic units from ten regions in Asia. The study involves a period where no intervention will take place at all recruiting units, and then at regular intervals, one cluster will be randomized to transit from non-intervention group to intervention group in which first-trimester screening for preterm-preeclampsia by the Bayes based method followed by the commencement of low-dose aspirin in high-risk women.

NCT ID: NCT03941639 Not yet recruiting - Breast Cancer Clinical Trials

Using Imaging Data and Genomic Data to Predict Metastasis of Breast Cancer After Treatment

Start date: June 1, 2019
Phase:
Study type: Observational [Patient Registry]

Breast cancer is the second leading cause of death for women around the world. Notably, most breast cancer patients die from tumor metastases in the liver, lungs, bones, or brain, not the primary tumor itself. Currently, clinicians are generally successful in treating primary tumors using standard protocols that are based on tumor sub-type and staging, as well as by the presence or absence of prognostic biomarkers. However, it remains difficult to assess in advance the likelihood of metastasis or relapse in any given patient.Physicians can only rely on regular post-treatment screening to monitor any secondary onset. By the time metastasis is detected, the golden window for treatment adjustment has often already passed. This project proposes to develop an analytical tool for predicting the likelihood of metastasis in breast cancer patients post-treatment using imaging and genomic data. We will evaluate our prediction model using prospectively-collected patient data. This new prognostic tool will enable physicians to adjust and tailor therapeutic strategies to each patient in a timely manner. Overall, the tool will personalize patient care, and improve their survival chances and quality of life.

NCT ID: NCT03937362 Not yet recruiting - Esophageal Cancer Clinical Trials

Pre-Surgery If Needed for Oesophageal Cancer

preSINO
Start date: July 1, 2019
Phase:
Study type: Observational

Prospective, multi-centre, diagnostic cohort study investigating the accuracy of positron emission tomography with computed tomography (PET-CT), endoscopic bite-on-bite biopsies and endoscopic ultrasonography (EUS) with fine-needle aspiration (FNA) in patients with potentially curable esophageal squamous cell carcinoma (SCC).

NCT ID: NCT03937297 Recruiting - Dementia Clinical Trials

A Culturally Appropriate Multimodal Non-pharmacological Intervention for Chinese People With Mild-to-Moderate Dementia

Start date: April 23, 2019
Phase: N/A
Study type: Interventional

This is a mixed-methods research that includes a single-blind three-arms randomized control trials and a focus group study. The quantitative study aims to investigate the additional clinical benefits of the Six Arts intervention over an evidence-based non-pharmacological intervention translated from western culture, cognitive stimulation therapy (CST). The qualitative part aims to explore the acceptance and understanding of family caregiver of the Six Arts intervention and CST. It is hypothesized that 1) the group who have received Six Arts intervention would show superior quality of life; 2) both Six Arts and CST groups would show superior cognitive improvement compared with usual care; 3) the Six Arts group would show greater improvement in behavioral and neuropsychological symptoms and functioning compared with the groups receiving CST or usual care.

NCT ID: NCT03937219 Not yet recruiting - Clinical trials for Renal Cell Carcinoma

Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

COSMIC-313
Start date: June 2019
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 676 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio (~338 per treatment arm) at approximately 150 sites.