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NCT ID: NCT04775329 Terminated - Clinical trials for Decompensated Cirrhosis

Primary Prophylaxis for Spontaneous Bacterial Peritonitis

SIBOC
Start date: November 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Patient with liver cirrhosis commonly have co-existing small bowel bacterial overgrowth (SIBO) yet may be asymptomatic. It is unclear as to the value of treating SIBO in asymptomatic individuals. Cirrhosis increase permeability of the gastrointestinal mucosa. It is postulated that in cirrhosis, endotoxins translocate across the gut mucosal barrier resulting in a second hit within hepatocyte perpetuating decompensation and spontaneous bacterial peritonitis. We hypothesise that cirrhosis patients with concomitant SIBO are particularly vulnerable for endotoxin translocation and would benefit from treatment. Treatment of SIBO would reduce the risk of spontaneous bacterial peritonitis and other liver-related morbidities. We aim to treat a cohort of patients with severe liver disease and concomitant SIBO with antibiotics as prophylaxis and compare the risk of spontaneous bacterial peritonitis, further liver-related morbidity and survival against untreated asymptomatic controls.

NCT ID: NCT04774770 Recruiting - Clinical trials for End Stage Renal Disease

HED-Start: Evaluating a Positive Skills Intervention for Patients New on Haemodialysis

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

Hemodialysis patients often experience barriers and misperceptions that hinder adjustment to life on dialysis. This study seeks to explore a group-based intervention (titled HED-Start) developed to improve self-care and emotional wellbeing among incident hemodialysis patients.

NCT ID: NCT04773132 Completed - Clinical trials for Metabolic Flexibility

Human Metabolic Flexibility: Its Role in Energy Regulation and Obesity

Start date: May 19, 2015
Phase: N/A
Study type: Interventional

Obesity is commonly described as a consequence of excess calorie intake. Conventionally, the physiological variables that have been of extensive interest are food intake and energy expenditure. Despite decades of research on factors influencing intake and expenditure, to date, no compelling theory has been promulgated to explain why certain humans are more susceptible to weight gain than others. The investigators hypothesize that the measure of an individual's fraction of energy mobilized or deposited as protein (P-ratio), contributes towards an obese morphology and may essentially form a novel approach in understanding the etiology, management and treatment of obesity. In addition, there is a general perception that the consumption of sugar sweetened foods and beverages are one of the major causes of obesity. This study aims to understand metabolic flexibility and the glycemic index of diets in the etiology of obesity. Individual metabolic flexibility may be the key factor that predisposes an individual to obesity. This study is carried out to determine the P-ratio in human subjects.

NCT ID: NCT04771273 Completed - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)

Start date: April 27, 2021
Phase: Phase 2
Study type: Interventional

This study is open for men and women with a liver disease called nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called BI 456906 helps patients with NASH and liver fibrosis. The study tests 3 different doses of BI 456906 to find the dose that helps best. Participants are put into 4 groups randomly, which means by chance. There are 3 groups that each receive a different dose of BI 456906 and there is 1 group that receives placebo. BI 456906 and placebo are given as an injection under the skin once per week. The placebo injection looks like the BI 456906 injection but does not contain any medicine. Participants are in the study for a little over 1 year (60 weeks). During this time, they visit the study site several times and have some video calls in addition. At the visits, the study doctors take different measurements. To see whether the treatment works, the doctors take a very small sample of liver tissue (biopsy) from each participant at the start and at the end of the study. They also examine the liver by ultrasound and MRI. The doctors also regularly check the general health of the participants.

NCT ID: NCT04768855 Completed - Healthy Clinical Trials

A Study of LY3540378 in Healthy Participants

Start date: March 17, 2021
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3540378 in healthy participants following single and multiple doses (Parts A and B) and multiple doses in Japanese (Part C) and Chinese (Part D) healthy participants. Blood tests will be performed to check how much LY3540378 gets into the bloodstream and how long it takes the body to eliminate it. This is a 4-part study and may last up to 70, 113, 113 and 113 days for each participant in Parts A, B, C, and D respectively.

NCT ID: NCT04765657 Active, not recruiting - Clinical trials for Hypercholesterolemia

Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD High Risk and Elevated Low Density Lipoprotein Cholesterol (LDL-C)

Start date: March 1, 2021
Phase: Phase 3
Study type: Interventional

A multicenter study to evaluate safety and efficacy of inclisiran in Asian patients with ASCVD or ASCVD high risk and elevated LDL-C

NCT ID: NCT04750395 Recruiting - Delirium Clinical Trials

Comparing Haloperidol and Olanzapine in Treating Terminal Delirium

HALOLAN
Start date: September 1, 2021
Phase: Phase 2
Study type: Interventional

As patients with terminal illness enter the dying phase, they may experience symptoms of restlessness, agitation, or cognitive disturbance, known as terminal delirium. In community care, pharmacological therapies are utilized to manage the syndrome, the most commonly used being neuroleptics haloperidol and olanzapine. However, there is currently a dearth of studies on the efficacy and safety between haloperidol and olanzapine in the community palliative care setting; existing studies involve non-terminal patients in the hospital suffering from acute delirium. To fill this gap, an open-label randomized clinical trial is proposed to compare the effects of haloperidol and olanzapine in the management of terminal delirium in home hospice patients who are imminently dying. Key outcome measures are the reduction of delirium symptoms and the reduction of agitation. Secondary outcome is comparing the adverse effect burden on patients.

NCT ID: NCT04749914 Completed - Healthy Clinical Trials

A Study of Lasmiditan in Healthy Volunteers

Start date: February 15, 2021
Phase: Phase 1
Study type: Interventional

The main purpose of the study is to investigate the blood concentrations of dabigatran etexilate and rosuvastatin when taken alone compared to when taken together with lasmiditan in healthy participants. The safety and tolerability of dabigatran etexilate or rosuvastatin in combination with lasmiditan will also be evaluated in healthy participants. The study has two parts. Each part will last up to 17 days, not including screening.

NCT ID: NCT04749368 Completed - Clinical trials for Hepatitis B, Chronic

Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection

Start date: April 12, 2021
Phase: Phase 2
Study type: Interventional

This is an open label, randomized, parallel-group study to evaluate the safety and efficacy of combination treatment BRII-835 (VIR-2218) and BRII-179 (VBI-2601) in adult participants with chronic HBV infection

NCT ID: NCT04748367 Completed - Pain Clinical Trials

Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care

Start date: September 9, 2020
Phase: N/A
Study type: Interventional

Paediatric immunization is often associated with significant fear and anxiety among children and their parents. Their distress can greatly affect their future adherence to the immunization schedule and the acceptance of recommended vaccines by physicians. This pilot was a single-centre, open label, randomised controlled trial to examine the use of VR analgesia in childhood immunization in primary care.The study primarily aimed to determine the feasibility of using immersive virtual reality (VR) during immunization in children by assessing the response rate of the participants during recruitment. The secondary outcome of the study was to determine the effectiveness of immersive VR in alleviating pain and anxiety among children during immunization compared to usual care without VR. It also aimed to determine the effectiveness of immersive VR in reducing anxiety among the parents and nurses during immunization procedure.