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NCT ID: NCT03919812 Completed - Tuberculosis Clinical Trials

Immunomodulatory Vitamin D in Thalassemia

ThalTB
Start date: April 1, 2018
Phase: N/A
Study type: Interventional

Thalassemia becomes one of global health issue and so does Indonesia. In 2015, more than 7600 children were diagnosed as this hemoglobin genetic disease wherein anemia and lifetime blood transfusion contribute to their morbidity and mortality in Indonesia. Major β-Thalassemia is the most common type found. However, along with disease progression and age, iron accumulation and dysregulation becomes the most common complication exist. In cellular level, this condition results in cell and tissue damage especially immune cells and promotes favor condition for siderophilic bacteria such as Mycobaterium tuberculosis (Mtb) to growth rapidly. Severe infection becomes the second most cause of death in thalassemia-β major patients. Tuberculosis (Tb) remains the global health issue especially in developing countries. Based on World Health Organization (WHO) report on 2015, Indonesia is the second highest burden of TB in the world. Both of adaptive and innate immune system plays important role in Mtb recognition and eradication. However, immune cells mechanism and activity in response to Mtb infection during iron accumulation condition on thalassemia-β major patients may be altered therefore need for further study. Macrophage is an adaptive immune cell, has a pivotal role on circulating-iron regulation and serves as Mtb host cell. To understand macrophage activity on thalassemia-β major patients can be studied by monocyte characteristic stimulated by Mtb antigen and evaluated by its differentiation into three subsets based on CD14 and CD16. Mtb antigen presentation is identified by HLA-DR expression on monocyte membrane. Vitamin D is one of the most affected micronutrients on major β-thalassemia patients, yet it has immunomodulatory effect on immune system. Recent finding of vitamin D receptor (VDR) expressed in monocyte strongly convince that vitamin D should be maintained in major β-thalassemia patients where it is found lower in these patients. Thus, this original and true report aimed to declare that the research activity has finished and the data has been elaborated. Future plan is developing the original article based on the research finding corroborating the previous knowledge and innovative suggestion for the quality of thalassemia.

NCT ID: NCT03909802 Not yet recruiting - Diabetic Foot Clinical Trials

Effect of Self- and Family Management of Diabetic Foot Ulcers Programs on Health Outcomes

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

Brief description: Diabetic foot ulcer (DFU) is described as a full-thickness lesion appearing at the skin of the foot along with infection, destruction of tissues due to neuropathy and/or peripheral artery disease (PAD) in people with diabetes (International Working Group on the Diabetic Foot, 2015). DFU commonly develops in middle-aged diabetic patients due to a long period of type 2 diabetes and poor adherence to control blood glucose level (Madanchi et al., 2013). Prevalence of DFU was four times higher than all combined cases of cancers in the world (Boulton, 2013; McInnes, 2012; Shaw, Sicree, & Zimmet, 2010). Numerous published studies have documented the rate of DFU at around 25% in Western Population (Boulton, 2013). Prevalence of DFU was stated between 7.3 % - 24 % at Indonesia hospitals (Soewondo, Ferrario, & Tahapary, 2013). An Indonesia nursing study recorded 12 % of diabetic foot ulcer cases from 249 individuals with type 2 diabetes in a regional hospital of Eastern Indonesia (Yusuf et al., 2015). Cases of infected DFU occurred in 98 patients in Sardjito Hospital Yogyakarta Indonesia in 2016 (Longdong, 2016). In order to diminish the wide-reaching impact of DFU, a number of efforts have been performed in Indonesia. A study documented that sufficient diabetic patients' knowledge in performing foot care is able to decrease the incidence of DFU as well as LEA (Wulandini, Saputra, & Basri, 2013). Foot ulcers health education program was interrelated with patients' knowledge as well as attitudes concerning responsibility and involvement in DFU care (Arianti, Yetti, & Nasution, 2012; Mahfud, 2012; Sa'adah, Primanda, & Wardaningsih, 2016; Yoyoh, Mutaqqin, & Nurjanah, 2016). In line with their findings, another study confirmed that intensive health promotion increased patients' knowledge and practice in regard to perform routine foot care (Abbas, 2013). Also, health promotion intervention improves Hemoglobin A1c (HbA1c) in type 2 Diabetes (Brown, 1990; Norris, Lau, Smith, Schmid, & Engelgau, 2002; Florkowski, 2013). However, a number of these studies merely focused on the patient, not engaged family members as it may potentially reduce the effectiveness of therapy. Accordingly, DFU is currently being a critical problems needs to be solved in Indonesia. Ensuring the engagement of both the patients and their families in treatment is an important strategy to deal with the chronic conditions (Baig, Benitez, Quinn, & Burnet, 2015; Miller & DiMatteo, 2013; Pamungkas, Chamroonsawasdi, & Vatanasomboon, 2017). Therefore, conducting a comprehensive intervention of DFU partnering individuals and their families in association with self-and family management is a groundbreaking and challenging strategy to overcome problems on DFU. We believe the findings of our study will render significant contributions to the national guideline of diabetes in Indonesia and prevention of LEA in nursing practice. Furthermore, it will be able to give promising results for accelerating DFU healing. Purposes of the study: The purpose of this study is to investigate the effect of a self- and family management of DFU programs on health outcomes as follows: behaviors (adherence to physical activities, medications, diet, foot care, and blood glucose control), family supports, biomarkers (HbA1c, wound size) in patients suffering DFU in Indonesia. Hypothesis: The study participants who joined completely the self- and family management of diabetic foot ulcer programs during three months would have a better behavior, biomarkers, and family supports than those who received the usual care.

NCT ID: NCT03907722 Completed - STEMI Clinical Trials

The 3q25 rs2305619 Polymorphism Associates With Microvascular Obstruction in STEMI

Start date: January 1, 2018
Phase:
Study type: Observational [Patient Registry]

The investigators enrolled 217 patients with acute STEMI undergoing primary PCI. The rs2305619 polymorphism was evaluated by real time PCR and plasma PTX3 concentration was assessed by human PTX3 ELISA kit.

NCT ID: NCT03899454 Not yet recruiting - Oxidative Stress Clinical Trials

Garcinia Mangostana L Rind and Solanum Lycopersicum Fructus Trial to Prevent Exercise-induced Oxidative Stress

GMR-RCT-EOS
Start date: April 15, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Treatments are an administration of a mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351) and placebo control.

NCT ID: NCT03895398 Recruiting - Weight Gain Clinical Trials

Post Disaster Nutrition Intervention for Under-two-year-old Children in Lombok Indonesia

NIELombok
Start date: December 12, 2018
Phase: N/A
Study type: Interventional

In 2018, multiple earthquake with magnitude range from 6 to 7 hit Lombok Island, West Nusa Tenggara Province, Indonesia. Following the situational analysis and baseline study in December 2018 (4 months after the first earthquake), it was found that the prevalence of wasting and underweight of underfive children in the affected population is moderate (10.2% and 28.8%) but the prevalence of stunting and anemia is considered of highly significant public health problem (33.3% and 43.8%). Various organizations have provided support at the emergency phase but there is no specific program for nutrition support at the rehabilitation phase. Draft of intervention model which utilize early child education (ECE) centers as center of nutrition recovery in the community has been discussed with the local education and health officers. Training will be delivered to ECE teachers and community health officers. ECE teachers are expected to have regular parenting class for nutrition education and activities, whilst the community health officers will monitor the activities and provide technical guidance as needed. Mothers of the underfive children will be invited to attend weekly parenting class at nearby ECE center in which they receive messages related to infant and young child feeding (IYCF), including distribution of liver and fish floss as nutrient dense food supplement to their children, and provision of appropriate psychosocial care.This parenting class will be held for 6 months with regular monitoring from the researchers and health personnel from public health center. Effectiveness of the intervention will be assessed in improving IYCF practices and psychosocial care of mothers and nutrient intakes, nutritional status and developmental outcomes of the underfives children.

NCT ID: NCT03895164 Enrolling by invitation - Anemia Clinical Trials

Linear Programming Approach to Develop Local Specific Food-based Complementary Feeding Recommendation

Start date: December 19, 2018
Phase: N/A
Study type: Interventional

Stunting and anemia amongst under-two children are attributable to poor nutrient intakes. The study evaluates the effectiveness of nutrition education on local specific food-based complementary feeding recommendation (CFR) to improve dietary patterns and nutritional intakes, as well as reduce stunting and anemia among under-two children.

NCT ID: NCT03895151 Active, not recruiting - Clinical trials for Nutritional Deficiency

Association Between Intakes of Protein, Calcium and Milk With Gene Expression and Linear Growth of School Aged Children

Start date: January 24, 2018
Phase: N/A
Study type: Interventional

Protein is one type of nutrients known as the cause of stunting in developing countries since the mid-1970s (1) but then less attention on protein intake with the assumption that protein intake is sufficient. Compilation of published and non-published dietary intake research among Indonesian children aged 3-12 years (2), 0-18 years old (3) and 1-3 years old (3) found that protein intake among Indonesian children was sufficient (4). This finding is also confirmed by some other studies in 6 low-income countries and lead to the conclusion that growth restriction is not due to protein deficiency (5). Since then, micronutrient received main attention for the past 4 decades (1) to improve the health and survival of young children in developing countries. Issues on the need to re-examined protein recently emerge after the paper of Semba (1,6) regarding the low circulating amino acid among stunted children. It was hypothesized that the correlation between the low level of circulating amino acid with linear growth was through the mechanism of rapamycin complex C1 (mTORC1) and general control nonderepressible 2 (GCN2) pathway that contributes in the synthesis of sphingolipids and glycerophospholipids (6). However, the mechanism on how amino acid link to linear growth remains unclear. Fortification among Asian children revealed that only milk as food vehicles reported a significant effect on linear growth (2). It is likely that the effect on linear growth is influenced not only on micronutrient content of the fortified foods but also on protein and amino acid profiles of milk as the food vehicle.

NCT ID: NCT03894176 Completed - STEMI Clinical Trials

Association of Plasma PTX3 Concentration and Outcomes of STEMI

Start date: January 1, 2018
Phase:
Study type: Observational

335 of patients with STEMI treated by primary PCI were assayed for PTX3 measurement by ELISA method. The angiographic and clinical outcomes were evaluated according to the PTX3 concentration.

NCT ID: NCT03893513 Recruiting - Clinical trials for Hemodynamic Monitoring

Comparison of Transthoracic Electrical Bioimpedance and Pulse Contour Analysis in Renal Transplantation Patients

Start date: March 12, 2019
Phase:
Study type: Observational

Hemodynamics monitoring using non-invasive transthoracic electrical bioimpedance ICON are compatible with standard invasive monitoring using pulse contour analysis EV1000

NCT ID: NCT03891589 Completed - Nutritional Status Clinical Trials

Optimized Complementary Feeding With or Without Home Fortification Prevents Decrease of Micronutrient and Growth

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Malnourished among under-five children characterized by growth faltering is a public health concern in Indonesia. It requires serious action from the governments because of the prevalence of underweight, stunting, and wasting are increasing. These impacts are irreversible resulting in the low quality of future human resources. Several studies showed that growth faltering among under-five children starts at age six months when the amount of breastmilk reduced, complementary feeding initiated, and risk for infection is increased. A rapid growth phase also causes growth faltering at age 6-24 months. The inadequate amount and low quality of food during this period can also lead to reducing nutritional status. The Indonesian Government released a national policy in 2013 to address undernutrition among under-five children called the Indonesia President Regulation No. 42/2013 regarding national movements on the acceleration of nutritional programs to address micronutrients deficiency among under-five children by providing micronutrient powder (MNP) (called Taburia) for children aged 6 - 59 months. Our literature review documented that there is no study ever conducted to evaluate the effectiveness of MNP (Taburia) in improving the weight and height of the children. Moreover, behavioral modification interventions to promote food diversification to improve nutrient intake and to prevent micronutrient deficiency are also never conducted. Based on the rationale and study concept, the following hypotheses are 1). Promotion of optimized complementary feeding along with or without multi-micronutrient powder or MNP (namely taburia) can prevent reductions in nutrient intake and density; serum ferritin and zinc levels; and anthropometric z-score index compared to controls, and 2) provision of MNP can prevent reductions in nutrient intake and density; serum ferritin and zinc levels; and anthropometric z-score index compared to controls.