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NCT ID: NCT04508075 Completed - SARS-CoV2 Infection Clinical Trials

Efficacy, Safety and Immunogenicity Study of SARS-CoV-2 Inactivated Vaccine

COVID-19
Start date: August 10, 2020
Phase: Phase 3
Study type: Interventional

This phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation

NCT ID: NCT04501354 Recruiting - Osteoporosis Clinical Trials

Evaluation of Clinical and Bone Density Improvement After Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord on Osteoporosis Patients

Start date: August 2020
Phase: Phase 2
Study type: Interventional

This study will assess the effectiveness of the allogeneic mesenchymal cell from umbilical cord in improving the quality and quantity of spinal density of osteoporosis patients proven by the results of Bone Mass Density (BMD) examination compared to baseline and evaluate improvement of quality of pain with visual analog scale (VAS).

NCT ID: NCT04501341 Recruiting - T2D Clinical Trials

BM-MNC and UCMSC for Type 2 Diabetes Mellitus Patients

Start date: March 14, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this preliminary study is to evaluate the safety and efficacy of bone-marrow mononuclear cells (BM-MNCs) and umbilical-cord tissue-derived mesenchymal stem cells (UC-MSCs) administration in type 2 diabetes patients

NCT ID: NCT04499105 Recruiting - Low Back Pain Clinical Trials

Effectiveness and Safety of Mesenchymal Stem Cell (MSC) Implantation on Degenerative Discus Disease Patients

MSC
Start date: July 24, 2017
Phase: Phase 2
Study type: Interventional

This study evaluates the effectivity and safety of MSC implantation on Degenerative Disc Disease Patients by assessing visual analog scale, ROM improvement and MRI examination.

NCT ID: NCT04493918 Recruiting - Clinical trials for Mesenchymal Stem Cell

Effectivity of Mesenchymal Stem Cell on Vertebral Bone Defect Due to Mycobaterium Tuberculosis Infection

Start date: May 21, 2017
Phase: Phase 2
Study type: Interventional

This study evaluates the effectiveness of locally implantation of mesenchymal stem cell on vertebral bone defects due to infection of mycobacterium tuberculosis. there are controlled participants who receives placebo and patients who receives implantation of MSc

NCT ID: NCT04462094 Completed - Inflammation Clinical Trials

Comparison of CRP Levels, Neutrophil Count, and Clinical Outcomes of Low Dose Ketamine Between at Anesthesia Induction and at the End of Surgery in Patients Undergo Elective Laparotomy

PRO-Ketamine
Start date: July 27, 2020
Phase: N/A
Study type: Interventional

The effects of anesthesia and surgery can lead to stress responses that result in hormonal and metabolic changes in the body. The immune system and the nervous system communicate both ways, and it was found that nociception and proinflammatory cytokines play a joint regulatory role, i.e., increased production of proinflammatory cytokines can worsen the pain. Major surgery can trigger the release of cytokines such as IL-1, IL-6, and TNF-α.

NCT ID: NCT04460287 Recruiting - Healthy Children Clinical Trials

Bioavailability of Different Formulas Enriched With DHA Using Wet Mixing or Dry Blending Method

Start date: February 17, 2023
Phase: N/A
Study type: Interventional

Infants and young children have high nutritional demands in order to support adequate growth and development, particularly during the transition from complementary feeding at 12 months of age to a mixed and varied diet at 36 months of age. Omega-3 long chain polyunsaturated fatty acid (n-3 LC-PUFA) such as docosahexaenoic acid (DHA; 22:6n-3) is the important constituents of the maturing brain, especially for visual and cognitive development. However only certain foods, such as fatty fish, contain n-3 LC-PUFA at concentrations sufficient for their needs. Additionally, these foods that are known to be rich in DHA may not be regularly provided to infants and toddlers due to concerns about potential food allergies or methylmercury exposure. Although the importance of consuming n-3 LC-PUFA and essential fatty acids at the level of dietary recommendations in late infancy and early childhood (6-24 months) are highlighted, the current median n-3 LC-PUFA and estimated DHA intakes in toddlers in most countries are lower than the recommended levels. The European Food Safety Authority (EFSA) recommend that infants and young children (< 24 months) should consume 100 mg of DHA per day, while for older children (2-18 years), they recommend a daily intake of 250 mg. In order to bridge the gap between the current intake and recommended levels of n-3 LC-PUFA, general foods, especially infant and toddler formulas, should be enriched with n-3 LC-PUFA particularly DHA. With a growing body of research, the challenge is to find an ideal formula that is nutritionally balanced and human milk-like, especially with respect to the ratio between omega-6 and omega-3 fatty acids and DHA level. In adding DHA into the toddler formula, there are several methods, among others are in the form of wet mix and dry blending. The aim of this study is to compare the bioavailability of different methods of adding DHA (dry blend versus wet mix) into formulas in healthy Indonesian toddlers age 2-3 years old for a period of one month. Furthermore, to evaluate the stability of milk-based formulas that are supplemented with DHA under same storage conditions, so as to monitor the stability of infant formula.

NCT ID: NCT04457609 Recruiting - COVID Clinical Trials

Administration of Allogenic UC-MSCs as Adjuvant Therapy for Critically-Ill COVID-19 Patients

Start date: July 2020
Phase: Phase 1
Study type: Interventional

Novel Coronavirus (2019nCoV) or Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) that causes Coronavirus Disease 2019, or known as Covid-19 has recently become a global health emergency since it was first detected in Wuhan, the People Republic of China in December 2019. Since then, the prevalence has rapidly increased worldwide. In Indonesia, by the end of April 2020, around 10,000 patients have been tested positive for Covid-19 infection, with a case fatality rate of around 8%. The pathogenesis of Covid-19 is still under investigation and to our understanding, ACE2 receptors in the alveoli serve as the binding site of the S-protein of envelope spike virus of SARS-CoV-2. TMPRSS2 enzyme aids the fusion between cell membrane and capsid of the virus, allowing penetration of virus into the cell. Vesicles containing virion fuse with cell membrane and released as new virions. Cytopathic effect of the virus and its ability to overcome immune response determines the degree of infection. Differences in immunological profile among degrees of severity of Covid-19 may vary especially for the number of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-α), interleukin (IL)-1, IL-6, IL-8, leukemia-inhibiting factors (LIF), immunological markers such as CXCR3+CD4+, CXCR3+CD8+ T cell and CXCR3+ NK cells, implying the ongoing cytokine storm. The previous studies also found increasing number for infection markers such as procalcitonin, ferritin, and C-reactive protein. The decreasing number of anti-inflammatory cytokines in such as IL-10 also supports this finding. Previous studies have shown immunomodulating and anti-inflammatory capacity of the mesenchymal stem cells (MSCs). MSCs contributed to the shifting of pro-inflammatory Th2 into anti-inflammatory Th2. One of the most recent study on the usage of MSCs on Covid-19 patients showed increased expression of leukemia inhibitory factor (LIF), which give rise to inhibitory effect of T lymphocyte and natural killer (NK) cell population. Vascular epithelial growth factor (VEGF) is found increasing following MSCs administration, which indicates the ability to improve the disrupted capillaries due to SARS-Cov-2 infection. The ability of MSCs in differentiating to alveolar cells is proven by the presence of SPM and SPC2, surfactant proteins produced by type II alveolar cells. MSCs are unable to be infected by SARS-CoV-2 since they don't have ACE2 receptors and TMPRSS2 enzyme.

NCT ID: NCT04453761 Active, not recruiting - Clinical trials for Congenital Heart Disease

Thiamine Influenced on Substrate Energy Effectiveness in Indonesian Children Undergoing Cardiopulmonary Bypass

Start date: July 1, 2018
Phase: Phase 4
Study type: Interventional

This is a randomized, double-blind, controlled trial design. It was conducted with a main purpose of evaluating the effect of thiamine supplementation on serum lactate and lactate-pyruvate ratio after surgery as direct indicators of tissue perfusion and indirect markers of energy substrate availability for effective mitochondrial function and intubation time as clinical outcome.

NCT ID: NCT04449588 Terminated - COVID-19 Pneumonia Clinical Trials

Efficacy and Safety Study of BDB-001 in Severe COVID-19 With ALI/ARDS

Start date: July 23, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This multi-center, open, randomized study will evaluate the efficacy and safety of BDB-001 injection in severe COVID-19 with severe pneumonia, or acute lung injury/acute respiratory distress syndrome. Patients will be randomized to two treatment arms (Arm A: Conventional treatment + BDB-001; Arm B: Conventional treatment alone).