Yogyakarta, Indonesia

Brief Mindfulness-based Intervention for Indonesian Teacher in Rural Area

Teacher in early childhood education (ECE) in Indonesia is experiencing high intense stress due to work environment, class management, child behaviour problem, and lack administrative support. Stress has also shown negatively impact their psychological well-being, quality of teaching, and to children's' executive function. Research about stress and the effects on teacher well-being is especially lacking for rural schools. They represent a forgotten minority and thus, teacher from rural area need a prompt and direct support in terms of stress management strategies. This study employs a randomized wait-list controlled trial design (RCT) with an assessment before and after treatment. 4-weeks brief mindfulness-based protocol will be given to 40 teachers as experimental group. 40 other teachers receive wait-list treatment will assign as control group. Measurement of perceived stress level will be using Indonesian version of Perceived Stress Scale (PSS), psychological wellbeing will be measure using Indonesian Well-being Scale (IWS), and mindfulness traits will be measure using Indonesian version of Five Factor Mindfulness Questionnaire (FFMQ). Data analysis using MANOVA and ANOVA to measure the differences between groups and within groups for all tests and constructs measured.

Allogenic UCMSCs as Adjuvant Therapy for Severe COVID-19 Patients

This is a randomized controlled trial. double-blind, multi-center clinical study conducted at three different hospitals, on 21 patients who received intervention and 21 patients who received control treatment. The purpose of this study is to evaluate the efficacy and safety of intravenous administration of normoxic allogeneic umbilical cord-derived mesenchymal stem cell (UCMSC) in the treatment group, compared to the control group who are only given standard COVID-19 treatments and normal saline infusion

Efficacy and Safety of EXOSOME-MSC Therapy to Reduce Hyper-inflammation In Moderate COVID-19 Patients

The current study is a multi-center, double arm, adjuvant, randomized control trial (RCT), double-blind clinical trial, to analyze the differences in the usefulness and safety of Exosome-MSC intravenous injection therapy in moderate-grade COVID-19 patients with hyper-inflammation (Evans S.R, 2010). This study used 2 groups (double arm) of study participants: Treatment Group (Intervention Arm): received treatment in the form of standard therapy and injection of Exosomes-MSC. Control Group (Control Arm): received treatment in the form of standard therapy and injection placebo. The time interval for the implementation of the study protocol was 14 days. For each group (Treatment and Control) the minimum target number of participating patients and according to the inclusion criteria in this study were 30 people. The minimum total number of participants with 2 groups (Treatment and Control) is 60 people. (Rohrig B., 2010) Random sample selection was carried out nationally from patients who entered the treatment room with a positive diagnosis of COVID-19 at the three Multi-Center Research Implementation Hospitals (RSPAD Gatot Soebroto Jakarta, RSUP Dr. Sardjito Yogyakarta and RSUP M. Djamil Padang) in the period 3 months after the issuance of Ethical Clearance and Approval for Implementation of Clinical Trials from BPOM. The sample size is calculated using the following formula: n1 = n2 = 2(Za+Z1-β)^2/ Δ^2 n1: the number of participants in the Exosome-MSC group n2: the number of participants in the control group Zα: standard deviation of type I error, 95% confidence interval (1.96) Zβ: standard deviation of type II error, power 80% (0.84) SD: standard deviation of duration of recovery on standard therapy (5.90). (Voinsky I, 2020) Minimum expected difference in duration of healing (in days) when using Exosome-MSC compared to standard therapy (5) From the above calculation, the results of the calculation are N1 = N2 = 21.83 with rounding up each = 22 participants . To anticipate the adequacy of the number of participants , each group was added 8 participants , 30 participants each in the Exosome-MSC group and the control group so that the total number of participants was 60 participants. Participants can be discontinued before the study is completed (drop-out) if they experience significant side effects and/or adverse events, both treatment related and non treatment related. Participants can also be discontinued before the study is completed (drop-out) if it worsens to a severe degree. All Participants will be discontinued from the study when the treatment and examination are completed according to the procedure. Randomization of patients into the intervention group or control group was made for each study site through the block 4 randomization technique. This process will be coordinated by the Team who will carry out the Research Management/CRO function. The double-blind procedure is a procedure to avoid bias of researchers and research participants that will affect the results of data analysis. To apply this procedure, the Exosome-MSC test material specimen in the Treatment Group was dissolved in 0.9% Nacl. The dosage form will be disguised so that it is similar to Nacl 0.9% in the Control Group. Research participants and local researchers implementing in hospitals do not have knowledge about the status of the research group (arm). During the study, patients continued to take their usual routine medications, such as antihypertensive drugs, antidiabetic drugs, calcium, or folic acid. The treatment will be included as a confounding factor. Research participants will be monitored closely. CLINICAL examinations are carried out EVERY DAY, starting from the baseline (day 0) to day 14. The clinical examination consists of: 1. body temperature, 2. oxygen saturation, 3. respiratory rate, 4. breath difficulties, 5. cough with phlegm, 6. RT-PCR results 7. standard therapy.received 8. allergic reactions, 9. secondary infection 10. side effects/ adverse events (AE) that are life threatening. 11. Remission score assessment based on 8 ordinal scales to determine Time to Clinical Improvement (TTCI). TTCI is the number of days until clinical improvement can be observed, as indicated by a score of 1-3 out of 8 ordinal scales. Laboratory examinations will be carried out on days 0, 1, 3, 7, 10 and 14 (unless they have been discharged/recovered first) . On days 0 and 7 when the Exosomes-MSC injection therapy is administered, laboratory examinations were performed before therapy. Laboratory examinations consist of: 1. C-Reactive Protein, 2. ferritin, 3. D-Dimer, 4. LDH 5. Fibrinogen, 6. Routine blood, type count (including lymphocyte count) 7. PT and APTT 8. SGOT/SGPT, 9. urea/creatinine, 10. electrolyte K/Na/Cl, Measures of intervention outcomes must be documented in a standardized Case Report Form (CRF) for each patient participating in the study. Adverse Events are any events, whether predicted or not, which can be related to the test material or not, this includes worsening of the clinical condition previously owned by the participant. Serious Adverse Events (SAE), include 1. Dead 2. Life threatening Inpatient / Participant requires treatment as an inpatient 3. Additional length of stay * 4. Permanent / significant disability 5. Congenital abnormalities Additional length of stay, defined as length of stay at any time. Hospitalization due to routine administration of standard therapy is not included in this definition. If the participant experiences an adverse event during the hospitalization period, the condition must be reported as an adverse event. All adverse events identified from the start of the study (day 0) to day 14 will be recorded in the adverse event form in the case report form (CRF). In the event of a Serious Adverse Events (SAE), researchers at the research site must report it to Dermama Biotechnology Laboratorium within 24 hours after it is known as the initial report, the report is addressed to: Dr. dr. Indah Hidajati Kampono, Sp.DV(K) Dermama Biotechnology Laboratory Jl. Kelengkeng No. 8 Surakarta Phone/Fax Number: 0271-727007 E-mail: Indahhidajati01@gmail.com Telephone/Mobile Number: +62 811-2632-086 Written reports of serious adverse events must be sent to the Ethics Committee within 3 calendar days and to Indonesian National Agency of Food and Drugs Control (BPOM) within 7 calendar days for SAE that are fatal or life threatening, and within 15 calendar days for other SAE according to BPOM Regulation No. 21/201514.

Indonesian Registry on Atrial Fibrillation

Adrecizumab Dose Escalation Safety and Tolerability Evaluation (ADESTE)

The objectives of this study are to determine the safety/tolerability together with PD parameters of an intravenous slow infusion of 3 increasing doses of HAM8101 (Adrecizumab) in patients with AHF in a Phase IIa safety clinical trial. Efficacy of HAM8101 (Adrecizumab) will be explored secondarily. The primary objective of this trial is to evaluate safety and tolerability of increasing doses of HAM8101 (Adrecizumab) in patients with AHF. Treatment emergent SAEs will be collected and carefully monitored on a continuous basis during the in-hospital stay and the 3-month follow-up after discharge. Treatment emergent AEs will be collected and monitored on a continuous basis during the in-hospital stay. Plasma and urine specimens will be collected daily from the first day of treatment until hospital discharge for routine safety assessments and to evaluate renal function. All subjects will receive phone calls 30 (±7) days from start of study drug infusion to assess the occurrence of adverse events and serious adverse events, mortality and hospital readmission for HF or renal dysfunction. Patients will be contacted again 60 (±14) days and 90 (±14) days after infusion of HAM8101 (Adrecizumab) to document survival and episodes of re-hospitalization. The study is designed primarily to understand the safety and tolerability of increasing doses of HAM8101 (Adrecizumab) in AHF patients (NYHA class II-IV) already in treatment and hemodynamically stabilized with a therapy that represents the standard of care (SoC) as recommended by international ESC 2016 Guidelines and it comprises 3 different patient "cohorts" with each cohort receiving one of 3 escalating doses of HAM8101 (Adrecizumab). In addition, the study will provide a PD profile of HAM8101 (Adrecizumab) in AHF, in this acute condition. After signing an Institutional Review Board approved Informed Consent Form, subjects will be asked to undergo screening procedures for study eligibility. Patients will be prescreened by site staff based on potential entry criteria as soon as possible after admission. Upon confirmation of eligibility and informed consent signature, the patient will receive the study drug within 48h from hospital admission. All patients will be evaluated daily during the hospitalization. In-hospital assessments of symptoms and signs of residual congestion (as composite congestion score) will be made daily from start of study drug infusion and up to Day 7, unless a patient is discharged earlier or later or dies earlier than Day 7. After discharge patients will be followed up for an additional 3 months for safety assessments with telephone contacts at months 1, 2, and 3, to document survival and episodes of re-hospitalization. Thirty (30) patients with AHF (NYHA class II-IV) will be enrolled into 3 sequential experimental cohorts during the inpatient setting: 0.5 mg/kg, 2 mg/kg and 8 mg/kg of HAM8101 (Adrecizumab). A control group of 10 patients with AHF will receive only standard of care treatment and will be monitored during the inpatient and outpatient settings.

Phase 3 Inhaled Novaferon Study in Hospitalized Patients With Moderate to Severe COVID-19

Virgin Coconut Oil (VCO) as a Potential Adjuvant Therapy in COVID-19 Patients

The subjects of this pilot study are patients diagnosed with COVID-19 in Central Public Hospital Dr. Sardjito, Teaching Hospital of Universitas Gadjah Mada (UGM), and Yogyakarta COVID-19 referral hospitals (RSUD Wonosari and Sleman). The COVID-19 patients are recruited according to the inclusion and exclusion criteria, then divided randomly into two groups. Group I, the intervention group, consists of COVID-19 patients receiving standard therapy and 15 mL of VCO twice a day for 14 days. Group II, the control group, consists of COVID-19 patients receiving standard therapy and 15 mL of placebo twice a day for 14 days. Both groups are monitored for four weeks with a nasopharyngeal or oropharyngeal Polymerase Chain Reaction (PCR) swab test.