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NCT ID: NCT05182203 Completed - Clinical trials for Rheumatoid Arthritis

Safety and Retention Rate of the JAK and TNF Inhibitors in Rheumatoid Arthritis: a Real-life Experience

Start date: March 1, 2022
Phase:
Study type: Observational [Patient Registry]

This study aims to extract data from the Hong Kong Biologics Registry for retention rate of the JAK inhibitors in rheumatoid arthritis and review other adverse events by looking at the medical record retrospectively. These real life data are important as they cannot be provided by randomized controlled trials which are limited by the duration of observation and fixed protocols in research settings. Moreover, data will represent our local experience of the JAK inhibitors in Chinese patients with RA. The retention rate and adverse effects of the JAK inhibitors are compared with conventional TNF inhibitors.

NCT ID: NCT04996368 Completed - Drug Use Clinical Trials

A Randomized Comparison of Two Doses of Tranexamic Acid in Open-Heart Surgery

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Perioperative bleeding during cardiac surgery is associated with a higher incidence of reoperation and blood transfusion leading to an increase in morbidity and mortality. Coagulopathy is a major cause of excessive bleeding. It is associated with use of cardiopulmonary bypass which activates the intrinsic and extrinsic coagulation pathway, platelet dysfunction and systemic inflammatory response. Increase in duration of cardiopulmonary bypass correlates directly with increase bleeding during cardiac surgery. Antifibrinolytic agents like tranexamic acid has shown promising result in major surgeries and in trauma patients. Current clinical practice guidelines recommended use of tranexamic acid in cardiac surgery. There are wide variations in dose of tranexamic acid ranging from 10mg/Kg to 100mg/kg. The higher dose of this drug is associated with seizures and thromboembolic events including stroke. The objective is to find out the minimal effective dose of tranexamic acid in open-heart surgery. This is a prospective comparative study among the patients undergoing open heart surgery in Shahid Gangalal National Heart Center, Kathmandu Nepal. The inclusion criteria include patients with age more than 18years, surgery with total cross clamp time more than 60 min. The exclusion criteria are the patients with allergy to tranexamic acid or any of the lysine analogues, history of seizure, chronic homeostasis abnormality, on anticoagulants, severe chronic kidney disease with creatinine clearance less than 30ml/hr, deranged liver function test, total cross clamp time less than 60 min. The sample size was calculated to be 100 including 10% dropout cases. Patients will be randomized into two groups Group H (High dose group) and Group L (Low dose group) with a sealed envelope technique. Low-dose TEA consists of 10 mg/kg bolus administration before incision, followed by1 mg/kg/hr infusion; High-dose TEA consists of a 30 mg/kg bolus followed by a 1mg/kg/hr infusion till the end of surgery. Blood sampling and transfusion will be done as per protocol of Shahid Gangalal National Heart Center. The primary study endpoint was the amount of blood loss during the first 24 hours after surgery. The secondary endpoint was the incidence of overall blood transfusion and hemoglobin concentration on the first postoperative day after surgery. All adverse effects of the drug were noted and were treated as per hospital protocol. Data will be collected using the data collection form (proforma). Collected data will be analyzed by means of spss version 20 for windows. The result will be presented as mean ± SD. The continuous variable will be compared between the two groups by student t test and categorical variables with the chi-square test. A minimum level of significance is maintained at the p-value of <0.05.

NCT ID: NCT04988646 Completed - Drug Use Clinical Trials

Pharmacokinetic Properties of 200 and 400 mg Acyclovir Tablet in Indonesia Healthy Subject

Start date: February 21, 2020
Phase: N/A
Study type: Interventional

The objective of this present study was to asses the pharmacokinetic properties of acyclovir tablet from new product formulation (PT. Kimia Farma (Persero) Tbk) to its innovator product, Zovirax® tablet (Glaxo Wellcome S.A., Aranda, Spain)

NCT ID: NCT04982874 Completed - Drug Use Clinical Trials

Bioequivalence Study of Furosemide 40 mg Tablet in 24 Indonesian Healthy Volunteers

Start date: December 13, 2019
Phase: N/A
Study type: Interventional

The purpose of this research was to investigate whether Furosemide 40 mg tablet manufactured by PT. Kimia Farma Tbk was bioequivalent to its reference drug and Lasix® 40 mg Tablet manufactured by PT. Aventis Pharma, Indonesia.

NCT ID: NCT04982861 Completed - Drug Use Clinical Trials

Bioequivalence Study of Cefixime Trihydrate Dry Syrup in Indonesia Healthy Volunteers

Start date: June 15, 2020
Phase: N/A
Study type: Interventional

This study was conducted to investigate whether 100 mg/5 mL cefixime trihydrate dry syrup manufactured by PT. Bernofarm, Indonesia was bioequivalent to its reference product, 100 mg/5 mL Suprax® dry syrup manufactured by Odan Laboratories Ltd., Canada registered trademark of Astellas Pharma Inc., Japan.

NCT ID: NCT04973033 Completed - Drug Use Clinical Trials

Effect of Tofacitinib in Treating ANCA-associated Vasculitis

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate the efficacy and safety of tofacitinib 5 mg twice daily in AAV patients.

NCT ID: NCT04964193 Completed - Drug Use Clinical Trials

Bioequivalence Study of Cyproterone Acetate and Ethinyl Estradiol in Healthy Female Volunteers

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

The study was conducted to investigate whether 2 mg cyproterone acetate (CPA) and 0.035 mg ethinyl estradiol (EE) film-coated tablet (Elzsa®) manufactured by PT. Sydna Farma was bioequivalent to its reference product, Diane®-35 sugar-coated tablet manufactured by Bayer Weimar GmbH, Germany, imported by PT. Bayer Indonesia, Depok, Indonesia.

NCT ID: NCT04870671 Completed - HIV/AIDS Clinical Trials

Project ADHERE: Clinical Proof-of-Concept of a Tenofovir (TFV) Aptamer-Based Biosensor

Start date: March 25, 2021
Phase: Early Phase 1
Study type: Interventional

Truvada®, an oral pill comprised of two anti-retroviral compounds, emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), is currently the only drug combination approved for pre-exposure prophylaxis (PrEP) in women exposed to high HIV risk through vaginal acquisition. Adherence to the one pill per day regimen is crucial for its effectiveness in reducing the risk of acquiring HIV. Currently, there is no available point of care diagnostic test to quickly measure blood levels of tenofovir in the clinic. This study will determine whether a tenofovir (TFV) aptamer-based biosensor (aptasensor) can detect TFV in biological fluids from women randomized to different dosing regimens representing high and low adherence.

NCT ID: NCT04650269 Completed - HIV Infections Clinical Trials

Implementation of Onsite, Rapid ART Initiation Among People Who Inject Drugs Living With HIV at Syringe Services Program

Start date: March 4, 2021
Phase: Phase 4
Study type: Interventional

The purpose of this study is to see if providing HIV medicine right away at the IDEA Syringe Services Program will help the participant start and remain in HIV care, including having no detectable HIV in the participant's blood.

NCT ID: NCT04595084 Completed - Depression Clinical Trials

Remotely Delivered Programs Targeting COVID-19 Stress-Related Depression and Substance Use

Start date: March 15, 2021
Phase: N/A
Study type: Interventional

This 3-arm study compares the effectiveness of an (1) 8-week mindfulness-based intervention, MBCT-R (Mindfulness-Based Cognitive Therapy for Resilience During COVID-19)+CHA MindWell vs. (2) iCBT (internet based Cognitive Behavioral Therapy)+ CHA MindWell vs. (3) CHA MindWell remote monitoring and telephone coaching alone on depressive symptoms as measured over the course of 24-weeks by the computerized adaptive mental health (CAT-MH) interview for depression (CAT-DI). Secondary outcomes include rates and levels of alcohol and drug use, as well as the number of required mental health clinician visits (televisits and in-person visits). Exploratory outcomes include stress-related affect reactivity and salivary inflammatory markers (e.g., interleukin-6).