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NCT ID: NCT05455164 Completed - Dietary Exposure Clinical Trials

The Effect of Eucaloric High-Protein Fiber Diet in Healthy Adults: A Repeated Single-Arm Clinical Trial

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The aims of this study is to investigate the effect of eucaloric high protein and fiber diet on healthy subjects.

NCT ID: NCT05449080 Completed - Genotype Clinical Trials

Disorders of Sex Development (DSD) 46.XY in Three Siblings

Start date: October 1, 2021
Phase:
Study type: Observational

This is a case series of three siblings with DSD 46,XY with relevant discussion

NCT ID: NCT05448924 Completed - Clinical trials for Growth Hormone Deficiency

Isolated Growth Hormone Deficiency and Amennorrhea

Start date: December 1, 2021
Phase:
Study type: Observational

This is a case report of a 14-year old female with no menstruation history.

NCT ID: NCT05444790 Completed - Malaria Clinical Trials

Abbott NxTekTM Malaria RDT WHO Prequalification Study

Start date: June 30, 2022
Phase:
Study type: Observational

Since their introduction in the late 90's, rapid diagnostic tests (RDTs) have dramatically improved our ability to control malaria but proved insufficient to support elimination efforts because of their limited sensitivity, especially for P. vivax. In addition, the spread of P. falciparum parasites lacking hrp2 gene jeopardizes the long-term use of P. falciparum-specific HRP2-based RDTs. A partnership between Abbott, FIND, PATH, and the Bill and Melinda Gates Foundation (BMGF) is addressing these limitations by developing two novel malaria RDTs with improved pLDH detection: a P. falciparum-specific test targeting both the HRP2 and PfLDH antigens on a single test line (NxTekTM Malaria P.f plus Rapid Diagnostic Test Device), and a P. falciparum/P. vivax combo test additionally targeting the PvLDH antigen on a second test line (NxTekTM Malaria P.f/P.v. plus Rapid Diagnostic Test Device). These new combo tests with improved pLDH detection may provide added value compared to currently available malaria RDTs, especially in settings where current tests prove to be insufficient due to hrp2 deletion or high burden of P. vivax malaria. Abbott, PATH, and FIND will conduct a prospective evaluation of NxTekTM Malaria P.f plus and NxTekTM Malaria P.f/P.v plus RDTs in malaria-endemic countries to assess their clinical performance for detection of malaria and usability in their intended-use settings. This is in support of a submission for WHO Prequalification.The purpose of this synopsis is to describe key points of alignment in study design and conduct across the portfolio of studies.

NCT ID: NCT05434585 Active, not recruiting - COVID-19 Clinical Trials

A Study to Evaluate Safety, Tolerability, and Immunogenicity of SARS-CoV-2 Variant (COVID-19) mRNA Vaccines

Start date: July 8, 2022
Phase: Phase 1
Study type: Interventional

A Phase 1 study to evaluate safety, tolerability, and immunogenicity of SARS-CoV-2 variant mRNA vaccines which are used to prevent COVID-19 caused by SARS-CoV-2 infection. this study is conducted during Indonesian subjects aged 18 years and older who have not received SARS-CoV-2 vaccines.

NCT ID: NCT05433285 Completed - COVID-19 Clinical Trials

Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine

Start date: June 7, 2022
Phase: Phase 3
Study type: Interventional

Observer-blind, randomized, active-controlled prospective intervention study

NCT ID: NCT05432440 Not yet recruiting - Asthma Clinical Trials

Evaluation of Pharmacist-guided Digital-based Asthma Education for Indonesian Children With Asthma

MIRACLE
Start date: August 20, 2022
Phase: N/A
Study type: Interventional

Poor adherence and self-management in children with asthma results in poorly controlled asthma and increased morbidity. Pharmacists could take important roles in delivering asthma education to ensure that children can manage their disease. This study aims to evaluate the effectiveness of improving asthma control, knowledge, and quality of life. An open, randomized controlled trial will be conducted to evaluate the effectiveness of pharmacist-led digital-based asthma self-management education for children with asthma compared with paper-based asthma self-management education. Recruitment of the participants will be held at the outpatient ward of the Department of Paediatrics in 4 public hospitals in Bali Province, Indonesia, including Sanglah Public Hospital, Denpasar City; Wangaya Public Hospital, Denpasar City; Mangusada Public Hospital, Badung Regency; and Udayana University Hospital, Badung Regency. Participants will be provided with informed consent, then randomly divided into either a control group or an intervention group. The following will be the hypotheses of the study: 1. The intervention group receiving the MIRACLE education program has a better asthma control compared to the control group. 2. The intervention group receiving the MIRACLE education program has a greater improvement in asthma quality of life compared to the control group. 3. The intervention group receiving the MIRACLE education program has a better understanding of asthma knowledge in general compared to the control group. 4. The intervention group receiving the MIRACLE education program has a better performance in practicing inhaler techniques compared to the control group. 5. The intervention group receiving the MIRACLE education program has fewer unscheduled visits to the hospital and less hospitalization compared to the control group. 6. The intervention group receiving the MIRACLE education program will be satisfied with the digital asthma education.

NCT ID: NCT05430087 Completed - Clinical trials for Systemic Lupus Erythematosus

Vitamin D and Curcumin Piperine Attenuates Disease Activity and Cytokine Levels in Systemic Lupus Erythematosus Patients

Start date: March 1, 2020
Phase: Phase 2
Study type: Interventional

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease with a relatively high mortality and morbidity rate, especially in developing countries such as Indonesia. In Indonesia, a previous study demonstrated that almost 71% of SLE patients experience hypovitaminosis D, with serum vitamin D 25 levels less than 30 ng/ml. Several factors contribute to the low vitamin D levels among SLE patients. Less exposure to sunlight or insufficient vitamin D intake contributes to SLE patients low vitamin D levels. Some other studies also revealed that vitamin D metabolism gene polymorphisms are also associated with patients with SLE. Vitamin D is essential for bone health and has an essential role in immune system modulation and controlling autoimmune diseases, including SLE. Another study demonstrates that curcumin supplementation in premenopausal women and dysmenorrhea improves vitamin D levels. Despite the promising properties of curcumin in improving vitamin D biological actions, our previous study reveals that the addition of curcumin in vitamin D administration do not significantly improve the disease activity or cytokine imbalance in SLE patients. The synergistic property of curcumin with vitamin D in regulating immune cells is an open opportunity for researchers to increase the response to vitamin D3 therapy. Several studies have reported the efficacy of vitamin D or curcumin for SLE treatment. However, none mentioned the combination of curcumin added with piperine and vitamin D3. We hypothesized that adding curcumin piperine with vitamin D3 as a complementary treatment in SLE patients would improve the clinical symptoms or cytokine balance among SLE patients. Therefore, this study aims to observe the effects of adding curcumin-piperine with vitamin D3 in clinical outcomes and cytokines levels in SLE patients with hypovitaminosis D.

NCT ID: NCT05422755 Completed - Clinical trials for Chronic Kidney Disease (CKD)

The Clinical Study to Evaluate Immunogenicity of Epodion® in Anemia Associated With CKD Patients

Start date: September 30, 2019
Phase:
Study type: Observational [Patient Registry]

The study was conducted to assess safety and immunogenicity of recombinant human erythropoietin (rhEPO) manufactured by Daewoong Pharmaceutical Co., Ltd was similar to biological products approved by the drug safety regulatory authority.

NCT ID: NCT05419973 Recruiting - Clinical trials for Vitamin D Deficiency

Vitamin D Levels in Umbilical Cord and It's Impact on Infant and Children's Health (VITADi Study)

VITADi
Start date: May 15, 2022
Phase:
Study type: Observational [Patient Registry]

This study is a cohort study that aims to assess the relationship between Vitamin D Levels in infant and the risk of anemia, atopic dermatitis, diarrhea and cardiovascular disorders in newborn. The subjects of this study are 100 women who met the inclusion criteria, which are in their third trimester of pregnancy and agree to be included in this study. These subjects then will be examined for their weight using standardized CEBA digital scale, height, upper arm circumference, and blood sampling will also be done to these women to measure their vitamin D levels, calcium, parathyroid hormone, ferritin, Fe serum, IL-16, IL-10. When subjects give birth, the babies will also be included in this study. Anthropometric examination will also be done on the babies, to measure their birth weight, birth length, and head circumference. Blood samples will also be taken from their umbilical cord to assess their complete blood count, ferritin, Fe serum, vitamin D levels, vitamin D receptors, IL-6 and IL-10. All subjects then will be monitored, and home visits will be done when the babies reach 3 months old and 6 months old. An assessment of the incidence of diarrhea, atopic dermatitis, and an assessment of cardiovascular disorders (checking pulse and blood pressure) will be carried out during the visit. At the end of the study, venous blood sampling will be taken to see levels of vitamin D, calcium, parathyroid hormone, routine complete blood count, serum Fe, and ferritin, then data analysis is performed.