Clinical Trials Logo

Filter by:
NCT ID: NCT03982186 Completed - Clinical trials for Hepatitis B, Chronic

A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection

REEF-1
Start date: August 1, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to establish the dose-response relationship for antiviral activity of 3 dose levels of JNJ-73763989+nucleos(t)ide analog (NA) and to evaluate the efficacy of combination regimens of JNJ-73763989+NA (with and without JNJ-56136379) and of JNJ-56136379+NA.

NCT ID: NCT03979690 Completed - Colorectal Cancer Clinical Trials

Feasibility Study of a Novel Single Use Robotic Colonoscopy System

Start date: June 12, 2019
Phase: N/A
Study type: Interventional

This is a single centre, non-randomized, tandem colonoscopy trial of the NISInspire-C System, followed immediately by a conventional colonoscope (CC). Each trial subject will undergo colonoscopy using the NISInspire-C system, followed immediately by CC. The purpose of this study is to obtain observational data on the safety profile, feasibility and usability of the NISInspire-C System in performing diagnostic colonoscopy in human subjects. The level of procedural pain experienced by subjects will also be explored.

NCT ID: NCT03969121 Completed - Clinical trials for Breast Cancer Female

Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable, Hormone Sensitive and HER2-Negative Primary Breast Cancer

Start date: July 16, 2019
Phase: Phase 3
Study type: Interventional

The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the efficacy of palbociclib in combination with Endocrine therapy over Endocrine therapy alone measured by PEPI and EndoPredict™ EPclin Score in women with operable HR+, HER2 negative breast cancer . The Clinical Response Rate, drop in Ki67 index ≤ 2.7% and Breast conserving rate will be compared between two arms.

NCT ID: NCT03959501 Completed - Type 2 Diabetes Clinical Trials

Metabolic Responses of Dapagliflozin vs Sitagliptin in T2DM Patients Inadequately Controlled With Insulin Therapy

Start date: August 16, 2017
Phase: Phase 4
Study type: Interventional

The use of sodium glucose co-transporter 2 inhibitors (SGLT2i) has been associated with increased serum ketone levels. However, most previous studies included subjects who were either insulin or even drug naïve with relatively short duration of diabetes. It is well known that insulin deficiency increases the risk of developing ketoacidosis with SGLT2 inhibitors. Moreover, since the glucose-lowering effect of SGLT2 inhibitors is at its maximum at 3 to 6 months after use, the extent of increase in serum ketone levels and its clinical relevance with chronic use of SGLT2 inhibitors, especially among insulin-treated patients that often have longer duration of diabetes and potentially more insulin deficient than those who are insulin naive, have not been clearly defined. Therefore, the investigators perform this randomised study to evaluate the effect of SGLT2 inhibitors on serum ketone levels among Chinese patients with T2DM inadequately controlled with insulin therapy.

NCT ID: NCT03954743 Completed - Clinical trials for Infections, Rotavirus

Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at 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 across the Porcine circovirus (PCV)-free development plan. This study used 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 were stored frozen in order to keep the titer stable until administration during the study. As the liquid formulation of GSK's HRV vaccine is not licensed in the US, the lyophilized formulation of the vaccine was used as a control in all phase III studies as part of the PCV-free development plan.

NCT ID: NCT03948763 Completed - Neoplasms Clinical Trials

A Study of mRNA-5671/V941 as Monotherapy and in Combination With Pembrolizumab (V941-001)

Start date: June 26, 2019
Phase: Phase 1
Study type: Interventional

This study will determine the safety and tolerability and establish a preliminary recommended Phase 2 dose of V941(mRNA-5671/V941) as a monotherapy and in combination with pembrolizumab infusion.

NCT ID: NCT03946748 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Study to Evaluate the Efficacy and Safety of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Start date: May 16, 2019
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to demonstrate a reduction in intravascular hemolysis by REGN3918 over 26 weeks of treatment in patients with active PNH who are treatment-naive to complement inhibitor therapy or have not recently received complement inhibitor therapy. The secondary objectives of the study are: - To evaluate the safety and tolerability of REGN3918. - To evaluate the effect of REGN3918 on parameters of intravascular hemolysis - To assess the concentrations of total REGN3918 in serum. - To evaluate the incidence of treatment-emergent anti-drug antibodies to REGN3918 over time - To evaluate the effect of REGN3918 on patient-reported outcomes (PROs) measuring fatigue and health-related quality of life

NCT ID: NCT03941886 Completed - Pre-Eclampsia Clinical Trials

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

FORECAST
Start date: July 31, 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: NCT03937297 Completed - 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: NCT03936439 Completed - Stroke Clinical Trials

Evolution of Ischemic Stroke Subtypes in Hong Kong

Start date: March 7, 2019
Phase:
Study type: Observational

Stroke is the 4th leading cause of mortality in Hong Kong. It also carries considerable socioeconomical consequences due to disability. Ischemic stroke can be classified by the TOAST classification, which includes large artery atherosclerosis, cardioembolism, small-artery occlusion and other causes (1). Among which, intracranial atherosclerosis (ICAS) had been major cause of acute ischemic stroke (AIS) in the Asia Pacific. It was estimated as high as 24.1% of AIS or transient ischemic attacks (TIAs) were attributed to ICAS in China (2). Management of ICAS related strokes has been challenging owing to its high rate of recurrence despite medical therapy. Recent randomized clinical trial suggested that aggressive medical therapy may result in reduction in recurrence compared with historical cohorts (3). Our group has previously observed a 2.5-fold increase in atrial fibrillation related stroke over a 15-year period (4). The inverstigator also observed a decline in ICAS related AIS as well as its recurrent stroke risk throughout the recent years. Possible mechanisms include better management of metabolic risk factors and aggressive secondary prevention. Other possible reasons are increased atrial fibrillation (AF), small vessel disease (SVD) or other stroke mechanisms. This study is aim to find the evolution of different stroke subtypes in relation to the characteristics of our stroke population over a 15-year period. This may influence territorial prevention strategy.