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NCT ID: NCT05202548 Completed - Immune Defect Clinical Trials

Immunology Dysregulation in Lymphadenitis Tuberculosis : An Observational Study Using Patient' Block Paraffins 2019 Until 2021

Start date: May 1, 2021
Study type: Observational [Patient Registry]

Mycobacterium tuberculosis (M. tuberculosis) infection is still a problem that cannot be overcome in Indonesia. In 2018 the number of tuberculosis (TB) sufferers in Indonesia reached more than 850/100,000 population, an increase around 20% from the previous year's incidence. One of the highest number of cases is in East Java Province, which is 38% of the total number of new TB cases in Indonesia. Extrapulmonary tuberculosis (EPTB) according to WHO classification criteria is an M. tuberculosis infection that occurs in tissues and organs outside the lung parenchyma. The incidence rate in Indonesia reaches 1-5% of the incidence of TB thus EPTB may often be forgotten. However, the diagnosis, therapy and monitoring post treatment in EPTB remains difficult to do. The focus of this research is tuberculous lymphadenitis (TB), due to 50% of EPTB cases in Indonesia was lymphadenitis TB. The risk factors for EPTB are immunocompromised conditions, such as HIV infection or comorbid conditions such as chronic kidney disease (CKD) and diabetes mellitus, but the mechanism of EPTB homing is still unclear. The mechanism of EPTB homing, especially TB lymphadenitis, really needs to be known for the development of diagnostics and therapy as well as preventing the occurrence of TB lymphadenitis. The importance of this research is to obtain compounds from the human immune response that can be developed as diagnostic markers and therapeutic targets for tuberculosis infection, especially TB lymphadenitis. Activated macrophages containing M. tuberculosis are carried by lymph flow to lymph nodes, where there is deposition of antigen-antibody complexes which then activate CC Chemokine Receptor-2 (CCR2) on lymphocytes, which are the primary receptors for Chemokine (CC motif) ligands ( CCL)-8 and CCL5, proteins expressed on macrophages containing M. tuberculosis. Activation of CCR2 increases the production of IL-10(10). IL-10 has been responsible for decreasing the secretion of TNF-, IFN-γ, and IL-1β (11). IFN-γ affects the process of M. tuberculosis elimination and the success of TB therapy, so that IL-10 is responsible for the failure of macrophages to eliminate M. tuberculosis. IL-10 also binds to Signal Transducer and Activator of Transcription 3 (STAT3) and STAT3 increases the release of Suppressor of Cytokine Signaling 3 (SOCS3). SOCS3 interferes with IFN-γ signaling for CCR2 recognition of M. tuberculosis-containing macrophages. On the other hand, the mechanism of T lymphocytes and macrophages that activate pro-inflammatory mediators (TNF-, IFN-γ, and IL-1β) and the association of IL-10 activation on STAT3, SOCS3 and CCR2 expression in the incidence of EPTB, especially TB lymphadenitis without TB infection remains unknown.

NCT ID: NCT05186246 Recruiting - Acne Vulgaris Clinical Trials

Effectivity and Safety of Combination of Spent Grain Wax, Argan Oil, Shea Butter and Saccharide Isomerate

Start date: December 20, 2021
Phase: Phase 1
Study type: Interventional

The clinical study will compare the efficacy and safety of Combination of Spent Grain Wax, Argan Oil, Shea Butter and Saccharide Isomerate cream post fractional CO2 laser. Combination of Spent Grain Wax, Argan Oil, and Shea Butter was formulated to reduce skin irritation and allergy symptoms such as dryness, itch and rash. The combination cream applied on one side of the face while placebo will be applied on the other side of the face in 18-60 years old female post fractional CO2 laser.

NCT ID: NCT05179070 Recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction HFrEF

Effect of Carvedilol Rapid Up-Titration in Patients With Heart Failure With Reduced Ejection Fraction

Start date: September 10, 2021
Phase: Phase 4
Study type: Interventional

Guidelines-directed medical therapy has improved dramatically outcomes in heart failure with reduced ejection fraction (HFrEF) patients. Beta-blockers have the most beneficial effects on all caused mortality and rehospitalization on HFrEF, but unfortunately, since the discovery of beta-blocker therapy in HFrEF, there was no change in the way of titration, start low go slow, which resulted in difficulties in reaching optimal doses for some patients.

NCT ID: NCT05165784 Completed - Clinical trials for Vascular Access Complication

Comparison of Techniques in Determining Femoral Veins Location

Start date: February 10, 2020
Phase: N/A
Study type: Interventional

This study aimed to determine the accuracy of the V technique in predicting the location of the femoral vein compared to the technique of palpating the femoral artery with the use of USGss as a standard in determining the exact location of the femoral vein.

NCT ID: NCT05156255 Recruiting - Clinical trials for Breastfeeding, Exclusive

Profile of Human Milk Oligosaccharides and FUT2 Polymorphism of Mothers in Indonesia

Start date: December 1, 2021
Study type: Observational

Human milk oligosaccharides (HMOs), the third most abundant constituent of breastmilk, are known to have beneficial effects on infant immunity. Maternal genetic polymorphisms cause HMO variability. The FUT2 gene determines the secretor status, whereas the FUT3 gene is responsible for the expression of Lewis fucosyltransferase. Therefore, breastmilk can be classified to four groups according to the variation. To date, this variability has not been investigated in Indonesia. This study aims to evaluate the association between FUT2 gene polymorphism and 2'-Fucosyllactose (2'-FL) secretor phenotype. In addition, infant FUT2 gene polymorphism and short chain fatty acid (SCFA) profile from stool samples are also analysed.

NCT ID: NCT05140928 Completed - Clinical trials for Gastrointestinal Microbiome

The Effect of Maternal Dadiah Supplementation During Pregnancy on Child Growth and Gastrointestinal Health Outcomes

Start date: August 20, 2020
Phase: N/A
Study type: Interventional

The aim of our study is to assess the effect of giving dadiah as a supplement to pregnant women on improving the growth and digestive health of children.

NCT ID: NCT05132972 Recruiting - Covid 19 Clinical Trials

Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients

Start date: January 17, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This study is conducted to assess the efficacy and safety of stem cells as adjunctive treatment for severe COVID-19 patients. Here, we want to study whether the administration of mesenchymal stem cells are safe and able to relieve some of the COVID-19 symptoms

NCT ID: NCT05131269 Recruiting - Frozen Shoulder Clinical Trials

Prolotherapy Intervention in Patient With Frozen Shoulder

Start date: July 1, 2021
Phase: Phase 4
Study type: Interventional

Introduction : Prolotherapy is regenerative tissue therapy that is considered to be efficacious in reducing symptoms and morbidity of frozen shoulder, but only a few studies demonstrate the effect of prolotherapy at the biomolecular level, particularly the level of Matrix Metalloproteinase- I (MMP-1), Tissue Inhibitor Matrix Metalloproteinase (TIMP-1), as the biomarkers of cartilage repair. Objective: To determine the effect of prolotherapy on MMP-1, TIMP-1, and functional outcomes in frozen shoulder patients Method: a double-blind randomized controlled trial study involving participants who had been diagnosed with Frozen Shoulder. History taking, functional outcome assessment, MMP-1, and TIMP-1 were measured. The prolotherapy via intraarticular and extraarticular was performed four times, followed by the evaluation of functional outcome, MMP-1, and TIMP-1 at week 12 Alternative Hypothesis : Prolotherapy will increase the MMP-1, TIMP-1 levels, and improve functional outcome among Frozen Shoulder patients

NCT ID: NCT05126602 Completed - COVID-19 Clinical Trials

Vitamin D Supplementation and Clinical Improvement in COVID-19

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

Background and objective Vitamin D is important as the interaction between vitamin D and its receptors at the immune cells stimulates innate and adaptive immunity. Deficiency in vitamin D is associated with increased susceptibility to infection and it is commonly found in Indonesia. Several studies indicate the potential of vitamin D supplementation against Coronavirus Disease 2019 (COVID-19), particularly in combating the proinflammatory situation as well as coagulopathy. This study aims to evaluate the supplementation of vitamin D in COVID 19 patients, particularly the changes in hematology parameters and other clinical parameters. Method A double-blind randomized clinical trial is conducted among moderate COVID 19 patients. High-dose of vitamin D is given orally in the intervention group, compared with a low dose of vitamin D. Hematology parameters, D Dimer, conversion time on Polymerase Chain Reaction (PCR) test, and clinical symptoms are assessed Hypothesis High Dose vitamin D shows a better hematology parameter, short PCR conversion time, and faster clinical recovery

NCT ID: NCT05126550 Recruiting - COVID-19 Clinical Trials

The Immunogenicity, Safety, and Effectiveness of the COVID-19 Inactivated Vaccine

Start date: November 13, 2021
Study type: Observational

To fast respond the coronavirus disease of 2019 (COVID-19) pandemic, the Indonesian government has launched "Vaksinasi Gotong Royong" (a mutual cooperation vaccination program) in which any company/legal entity/business entity may purchase vaccines to be given free of charge to their employees and families of employees (The Indonesian Ministry of Health, 2021). Vaccines provided for this program include the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) inactivated vaccines produced by Sinopharm. The Indonesian National Agency of Drug and Food Control (NADFC) has issued an Emergency Use Authorization (EUA) for several COVID-19 vaccines, including the SARS-CoV-2 vaccine (Vero cell) inactivated produced by Sinopharm (NADFC, 2021). Following EUA, Kimia Farma Indonesia as the holder of EUA has the obligation to monitor the safety and effectiveness in Indonesian population.