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NCT ID: NCT04728529 Recruiting - Septic Shock Clinical Trials

Septic Shock Management Guided by Ultrasound: SEPTICUS Trial

Start date: September 2, 2021
Phase: N/A
Study type: Interventional

This clinical study aims to compare the recent septic shock management protocol from American College of Critical Care Medicine (ACCM) to Ultrasound-guided Septic Shock Management (USSM) protocol. USSM protocol laid on Doppler ultrasonography to evaluate stroke volume, cardiac index, and systemic vascular resistance in each step of management to decide the proper fluid resuscitation and vasoactive therapy; differs from ACCM protocol which use clinical finding in its early step. ACCM protocol application elicits risk of improper therapy since clinical sign per se often could not describe the certain cardiac output. This can be prevented earlier by USSM protocol. The outcome compared of the two protocols is: mortality rate, clinical parameter, macrocirculation hemodynamic parameter, laboratory microcirculation parameter, and signs of fluid overload. The investigators hypothesized if the USSM protocol had a better outcome and less fluid overload complication.

NCT ID: NCT04724525 Completed - Clinical trials for Visual Acuity Reduced Transiently

Changes in Power and Cylinder Axis of Toric Soft Contact Lenses (LKL)

Start date: November 17, 2020
Phase: N/A
Study type: Interventional

Astigmatism is a common refractive error resulting from a toric-surfaced cornea which using a toric soft contact lens could be one of the therapy options. Due to the numerous possible combinations between sphere powers, cylinder powers, and cylinder axes, manufacturers of disposable soft toric contact lenses limit their toric lens range, while still aiming to cater to the majority of astigmatic patients. Due to that reason, the possibility of astigmatism patients getting a different combination of power and axis with toric soft contact lenses sold on the market will be high due to SKU limitations. This research aims to ascertain the impact of altering cylinder power and axis on visual quality and convenience in astigmatism participants using toric soft contact lens. The study was conducted at Kirana Ciptomangunkusumo Hospital, Jakarta, starting in April 2020. The study is a prospective, randomized, participant-masked, crossover clinical trial where the participants were tested for the following conditions on different days using full spherocylinder correction and under-correction by 0.25, 0.50, and 0.75 DC while maintaining spherical equivalence. Axis was also misaligned between -30° and +30°, in 10° steps. For each visit, the patient was examined visual acuity, contrast visual acuity using the Pelli-Robson, and assessed patient comfort using the VAS method.

NCT ID: NCT04715360 Recruiting - Covid19 Clinical Trials

Management of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy

Start date: December 29, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The positive cases of coronavirus disease-2019 (COVID-19) in Indonesia has been increasing rapidly since the first case found in March 2020 to date. Coronavirus 2 (SARS-CoV-2) virus disrupts human normal immune system resulting in uncontrolled inflammatory response. Based on our research and experience in doing cell therapy for 9 years, activated platelet-rich plasma (PRP) produces anti-inflammatory effects in inflammatory condition that is beneficial for tissue regeneration. In this study, we aimed to evaluate the potential of autologous activated platelet-rich plasma (aaPRP) and the outcomes for treating severe Coronavirus Disease-2019 (COVID-19) patients in Intensive Care Unit (ICU).

NCT ID: NCT04715204 Completed - Clinical trials for Severe Acute Malnutrition

Gastrointestinal Tolerance of Under-five Children With Severe Acute Malnutrition to ONS Compared to F-75/F-100

Start date: September 4, 2019
Phase: N/A
Study type: Interventional

The primary outcome of the study is to identify gastrointestinal tolerance of under-five children with severe acute malnutrition to ready-to-drink high energy (1.5 kcal/ml) and standard energy (1 kcal/ml) oral nutrition supplement (ONS) compared to Formula-75/Formula-100. The secondary outcomes of the study are weight gain, electrolyte profile and plasma amino acid profile at the beginning and the end of stabilization phase. In this randomized, controlled trial, 108 patients with severe acute malnutrition will be enrolled. Patients are randomly assigned to 3 groups (Formula-75/Formula-100, high energy ONS, and standard energy ONS) to undergo a two-week treatment. In order to ensure an adequate intake, nasogastric-tube will be placed for home enteral nutrition for at least throughout the two-week study period. Parent or caregiver will be asked to record daily intake, vomit, and defecation score using Bristol stool chart.

NCT ID: NCT04706585 Not yet recruiting - Thalassemia Clinical Trials

Thalassemia Knowledge in Young People of Indonesia

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

There is still an ongoing lack of awareness about thalassemia among Indonesians despite high disease prevalence, and this is associated with poor implementation of preventive and promotive measures. Thalassemia experts argue that education and raising awareness about thalassemia must be done from an early age in order to relieve the heavy disease burden of thalassemia, especially in Indonesia as it is geographically located in the thalassemia belt. In spite of this, there has been limited research on public perception towards thalassemia in Indonesia, particularly among young people. In this study, the researcher will ask young people in Indonesia between the age of 15-24 who are currently attending high school or university-level education to fill in an online survey. The survey consists of questions about the participants' demographic information as well as their knowledge, attitude, and practice (KAP) scores towards thalassemia. The study is expected to run from December 2020 to March 2021, with the online survey distributed in January 2021. Data collection will immediately follow, and it will be analyzed using univariate, bivariate, and multivariate analysis using the appropriate statistical tests. The findings gathered from this study will be vital in providing new insight into how the youth sees thalassemia in Indonesia. Such public health information will prove to be important in designing successful thalassemia intervention and education programs for Indonesian youth.

NCT ID: NCT04698759 Completed - Stunting Clinical Trials

Immune and Scfa Profile of Stunting Children

Start date: January 9, 2020
Phase:
Study type: Observational

1. Type and Research Design A cross-sectional study design with a quantitative approach will be conducted. Cross-sectional research design is one-time research to find a relationship between the independent variable (risk factor) and the dependent variable (effect). 2. Time and Location of Research The research will be conducted for approximately six months in 2020 at Banten Regency (namely Tegal Ongok and Pasirkarang) and Sumedang Regency. 3. Population and Research Sample The population is children between three and five years old in the village of stunting locus. The sampling method to be used in this research was quota sampling, namely 50 stunting and 50 healthy children from each Regency.

NCT ID: NCT04694235 Recruiting - Child Development Clinical Trials

Egg Intervention During Pregnancy in Indonesia

PRECODE
Start date: February 12, 2021
Phase: N/A
Study type: Interventional

The study consists of two arms: 1) intervention group using eggs as supplementary food given from 2nd trimester of pregnancy to birth, and 2) observational group of pregnant mothers. it aims to assess the effectiveness of improving dietary quality during pregnancy on the epigenetic and stunting related outcomes (growth and development) in infants, who will be followed up until 24 months old

NCT ID: NCT04690387 Completed - COVID-19 Clinical Trials

Dendritic Cell Vaccine, AV-COVID-19, to Prevent COVID-19 Infection

Start date: December 7, 2020
Phase: Phase 1
Study type: Interventional

This is an adaptive Phase I trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults.

NCT ID: NCT04689984 Recruiting - Clinical trials for Painful Diabetic Neuropathy

The Benefits of Astaxanthin as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient

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

Diabetes is one of the main health care problemsworldwide with 5% average increased number of cases every year. According to International Diabetes Federation the prevalence of people with diabetes reached the number of 425 million people in 2017 and estimated rising to 628 million by 2045. Painful Diabetic Neuropathy (PDN) is the most common complication of diabetes affecting 90% of the patients. The symptoms of PDN include numbness, burning, stabbing pain, paraesthesia or hyperesthesiaof both symmetrical limbthat could reduce the quality of life. Several studies have found several therapeutic options to cope with pain in the PDN, but the results are not as satisfactory due to the uncertain pathophysiology of the disease and the limitations of the drug that can be administered because of itspolypharmaceutical side effects. The causes of diabetic neuropathy not only include vascular and metabolic factors but also Reactive Oxygen Species. There are several therapeutic options that can be administered such as glycemic index arrangement,foot care, symptomatic treatment, and predominantly pain therapy. According to guidelines, there are drugs therapy thatrecommended for PDN, among others, Gabapentin, Pregabalin and anticonvulsants until the pain subsides. Unfortunately, this treatment is only aimed at relieving the symptoms of existing pain but not working on existing pathophysiological mechanisms and fixing sensory deficits of neuropathy trials. Multi-target treatments is needed to attenuate neuronal inflammation, oxidative stress and apoptosis. Additional therapy can be an option to support healing and also the process of metabolic pathophysiology that occurs due to rising glycemic index in the body that causes the work of hexosamine pathway and trigger the formation of ROS and inflammation. There is evidence of research demonstrating the neuroprotective effects of Astaxanthin as oxidative, anti-inflammatory and anti-apoptotic agent. Not only that, Astaxanthin is also a good supplement addition with no toxic effects when consumed, as well as hydrophilic and also lipophilic nature which makes Astaxanthin can penetrate the BBB effectively.

NCT ID: NCT04689971 Recruiting - Clinical trials for Painful Diabetic Neuropathy

The Benefits of Vitamin B Combination as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient

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

Large population-based study has shown that the prevalence of painful diabetic neuropathy (PDN) is around 21%, and painful symptoms are more prevalent in patients with type 2 diabetes, females, and Asians. PDN is characterized by symmetrical lower limb paresthesiae, dysesthesiae, lancinating pains and allodynia, with nocturnal exacerbation. PDN cause sleep disturbance and reduce quality of life. The international guidelines advocate a range of therapies for symptom relief. The therapeutic efficacy for all recommended medications is at best around 50% pain relief and is limited due to unwanted side effects. Apart from peripheral and central alterations, metabolic alterations such as increased glycemic influx, and elevated plasma methylglyoxal levels have been implicated in the pathogenesis of PDN. Several treatment options for PN are available, including pharmacological, non-pharmacological, and alternative options. Patients suffering from severe and disabling symptoms (e.g. NeP) may require guideline treatments like pregabalin, duloxetine, or gabapentin initially until the symptoms are under control. These medications can symptomatically relieve NeP; however, they do not address the underlying cause. Other options such as neurotropic B vitamins (B1, B6, and B12) do not only target the symptoms, but also improve nerve health and contribute to nerve regeneration. The B vitamins are commonly used for PN treatment in clinical practice worldwide, this treatment option is most suitable before the patient suffers from chronic NeP. However, co-treatment with neurotropic B vitamins is also appropriate in NeP patients, to ensure the restoration of nerve health.