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NCT ID: NCT04540055 Completed - Anesthesia Clinical Trials

General Anesthesia and Paravertebral Blocks vs. General Anesthesia Only: Influence Inflammation Factors and Clinical Outcomes in Modified Radical Mastectomy

Start date: October 1, 2020
Phase:
Study type: Observational

Regional anesthesia and analgesia may maintain immune function, reduce surgical stress, and also reduce volatile anesthetics and opioids requirements. Local anesthetic drugs used in regional anesthesia and analgesia work to have anti-proliferative and cytotoxic effects on cancer cells. Pro-inflammatory cytokines such as IL-1, IL-6, and TNF-alpha increase in levels in peripheral nerves, spinal cord, brain (brain stem, locus sereleus, thalamus, hippocampus, and prefrontal cortex) after peripheral nerves are injured. The anti-inflammatory cytokine IL-10 is decreased in levels after peripheral nerve injury. The balance between pro-inflammatory and anti-inflammatory cytokines affects the severity of pain.

NCT ID: NCT04535856 Completed - Covid19 Clinical Trials

Therapeutic Study to Evaluate the Safety and Efficacy of DW-MSC in COVID-19 Patients

DW-MSC
Start date: November 14, 2020
Phase: Phase 1
Study type: Interventional

This is a phase 1 clinical trial to verify the safety and efficacy of DW-MSC in COVID-19 patients. A total of 9 subjects are randomly allocated. Subjects who meet the final inclusion and exclusion criteria are randomized to the test groups (low-dose group and high-dose group) or control group (placebo group) in a ratio of 1:1:1. Subjects assigned to the test groups were administered intravenously once with 5 x 10^7cells of DW-MSC for the low-dose group or 1 x 10^8cells for the high-dose group after registration. Subjects assigned to the control group were administered with placebo in the same manner as the test drug (DW-MSC). At this time, all of the existing standard co-treatment are allowed. DW-MSC is adjunct therapy to standard therapy. This clinical trial is a double-blind trial, in which a randomized method will be used. To maintain the double-blindness of the study, statistician who do not participate in this study independently generate randomization code. Subjects will be randomized to the test groups (low-dose group and high-dose group) or the control group (placebo group) in a 1:1:1 ratio. After the completion of the trial, the randomization code will be disclosed after unlocking the database and unblinding procedures. Follow Up period: observed for 28 days after a single administration

NCT ID: NCT04515264 Completed - Clinical trials for Growth; Stunting, Nutritional

Human Milk Oligosaccharides (HMOs) Profiles and Growth Indicators of Infants Aged 0-4 Months

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

The breastfeeding rates globally in Indonesia generally remain low with only 40% or less infants aged 6 months are exclusively breastfed. Available national data in 2018 showed the proportion of wasted in children under 5 years old was 6.7%, while 3.5% children were severely wasted. This data showed improvement compared data in 2007 and 2013. While proportion children under 2 years old with stunted and severly stunted was 29.9%. As the third most abundant group of compounds in human milk, after lactose (70 g/L) and lipids (40 g/L), human milk oligosaccharides (HMOs) never been study in Indonesia. HMOs amount and diversity influenced by non modifiable and modifiable factors. The maternal phenotypes, the α-1-2-fucosyltransferase (FUT-2) gene and the α-1-3-4-fucosyltransferase (FUT-3) gene divided the mother into secretor (Se+) and non secretor (Se-) and Le+ or Le-). Studies showed the breastfed infants of non secretor mothers secrete lower HMOs than secretor mothers. By many functions in HMOs such as prebiotic, anti infection, modulate immunity, it is thought that HMOs can influence infant growth. The hypothesis of this study is to show the associations between maternal factors (secretor gene status/FUT-2 gene, lewis gene status/FUT-3 gene, gestational age and gestational weight gain) with HMOs profiles and growth indicators of infants aged 0-4 months.

NCT ID: NCT04511299 Completed - Surgery Clinical Trials

Impact of Fish Oil-enriched Lipid Emulsion on Fatty Acid and Inflammatory Response in Infants After Surgery

Start date: April 7, 2020
Phase: N/A
Study type: Interventional

This study aim to compare the impact of fish oil-enriched intravenous lipid emulsion to standard Intravenous lipid emulsion on fatty acid composition and inflammatory response (IL-1β and IL-8 levels) in infants after gastrointestinal surgery. Our hypothesis is the fish oil-enriched intravenous lipid emulsion can improve the fatty acid composition and lower the inflammatory response.

NCT ID: NCT04509453 Completed - Anesthesia Clinical Trials

McGRATH vs Macintosh Laryngoscopy Comparison in LMA Insertion

GRAN-PALM
Start date: August 30, 2020
Phase: N/A
Study type: Interventional

Various techniques have been developed to get a good LMA position, one of them is using a laryngoscope. The most popular laryngoscope used for LMA installation is the Macintosh type. Technological developments have brought laryngoscopes into the video era, one of which is McGRATH's laryngoscope, which from several studies about having an advantage in terms of the first attempt, time, complications, and hemodynamic stability of intubation. It needs to be proven through research on the comparison of clinical outcomes of LMA installation with McGrath laryngoscope and Macintosh laryngoscope.

NCT ID: NCT04509141 Completed - Migraine Clinical Trials

Acupuncture as Migraine Prophylaxis in Reducing Frequency, Duration and Intensity of Migraine With Minimum Acupoint, Seen up to Eight Weeks From Baseline

Start date: July 5, 2019
Phase: N/A
Study type: Interventional

Migraine is a primary headache attack, specific, paroxysmal, with or without aura, with subjective manifestations both before and after the attack, a chronic type of headache with symptoms of recurrence, attacks at productive age and can cause a decrease in work productivity up to 80%, so that it will affect the quality of life, economic life and education globally which leads to losses for migraine sufferers and institutions where migraine sufferers attend school, work and in the lives of sufferers' families.

NCT ID: NCT04508283 Completed - Healthy Children Clinical Trials

Fiber Intake Among Children in Relation to Milk Type, Gastrointestinal Symptoms and Iron Status: a Cross-sectional Study

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

Fiber as part of the plants can be provided through eating grains, fruits and vegetables. As source of fiber, exclusively breastfed infants do not need additional dietary fiber because breast-milk provides oligosaccharides to maintain the bulk for normal gastrointestinal movements together with gut probiotics. However, after the period of six months of exclusive breastfeeding, then complementary foods are the initial sources of fiber of children aged 6-59 months diet, e.g. cereals, fruits and legumes should then be introduced. However, investigators should consider on the effect of plant foods as a non-haem iron food source that is less bioavailable for iron absorption. There are other dietary factors that inhibit iron bioavailability, i.e. phytates in grains and rice, vegetables protein, calcium and phosphorus in cow's milk and cheese. iron deficiency is remained common globally, especially for children age 6-24 month in which it can developing into a severe condition, i.e. iron deficiency anemia. Iron deficiency as well as anemia is closely related to delay child growth and development, negatively associated with height-for-age, and anemia are at risk for poorer cognitive, motor, social-emotional, and neurophysiologic development in the short- and long-term outcome. The aim of this study is to see the association between fiber intake from different type of milk consumption sources and dietary habits to gastrointestinal health, anemia and growth status among children aged 6-36 months.

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: 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: NCT04440319 Completed - Clinical trials for Type2 Diabetes Mellitus

Diabetes Nutrition Education With Glycemic Control

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

T2DM in Indonesia has increased dramatically from 7.0% in 2017 to 10.9% in 2018. In Padang, West Sumatra, diabetes prevalence was 1.3% in 2013 and increased slowly in 2018. Majority of T2DM were not able to achieve optimal glycaemic glucose control measured using HbA1c with a target of less than < 6.5% based on WHO recommendation. Problem Statement NCD guidelines provided management DM in general. Pedoman Gizi Seimbang was for healthy people. It is crucial to update the guideline following the current issues even the Indonesian consensus in 2015 provided a T2DM management diet. Study Hypotheses There is a significant difference in glycemic control (HbA1c and FBG) nutritional status, knowledge, attitude, practice, quality of life, acceptability and adherence behavior among individuals with T2DM in intervention group. Procedures Subjects will be divided into Intervention and control groups after they finished reading, signed a letter of agreement and informed consent. Subjects also have the right to be withdrawn after listening explanation of the investigators to seeking the potential participants based on inclusion criteria. The individual with T2DM (intervention group) will follow the Diabetes Mellitus Nutrition Education (DNE) program based on the curriculum of DNE modules properly and certain measurements. There is a selected nutritionist at each PHC who will convey the DNE program. DM nutrition education counseling will be delivered every week for 30 minutes. Individual with T2DM - Baseline An individual with T2DM will be asked to fill the questionnaire and follow all of the measurements (Nutritional Status, Biochemical, Clinical, and Dietary Intake). - Intervention (3 months) All of the subjects will follow the DM Nutrition Education program for 3 months which will be delivered by nutritionists in PHC. - Follow up (3 months) All of the subjects will continue the program independently in 3 months. Then, the subjects will do the same activity as a baseline to compare the data between baselines, intervention and follow up Control The individual with T2DM in the control group will still follow the conventional DM nutrition education. After the DNE program finished, the material will also be distributed to the individual with T2DM in the control group.