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NCT ID: NCT06165575 Recruiting - Post-operative Pain Clinical Trials

The Effect of Press Needle in the Combination of Ear and Body Acupuncture Points on Visual Analog Scale in Post-Operative Patients of Open Spine Surgery

Start date: October 13, 2023
Phase: N/A
Study type: Interventional

Postoperative pain is pain that arises after a surgical procedure, resulting from trauma during the surgical incision process. It is generally acute in nature and is accompanied by an inflammatory response. Spinal surgery is a surgical procedure used to address issues typically involving pain in the spinal or back area. Commonly used postoperative analgesics are opioid types administered intravenously. All types of opioids exhibit similar side effects, particularly in terms of respiratory depression, which can lead to hypoxia and respiratory arrest. Other side effects include nausea, vomiting, itching, decreased intestinal motility leading to ileus, and constipation. The press needle acupuncture, a specialized acupuncture needle developed from intradermal needles, is being used. The advantage of the press needle is its minimally invasive nature, relative affordability, safety, and the ability to continuously stimulate acupuncture points for several days, generally without causing serious side effects. This study aims to determine the effectiveness of the combined therapy of press needle acupuncture and medication in treating postoperative pain in patients who have undergone open spinal surgery. The study follows a double-blind randomized clinical trial design and is conducted at the inpatient units of Dr. Cipto Mangunkusumo National General Hospital (Rumah Sakit Umum Pusat Nasional Dr. Cipto Mangunkusumo), University of Indonesia Hospital (Rumah Sakit Universitas Indonesia), and Fatmawati General Hospital. The research is a collaboration between the Medical Acupuncture Department of Faculty of Medicine at the University of Indonesia and the Orthopedics and Traumatology Department. The study employs press needle acupuncture on 8 acupuncture points, 4 ear acupuncture points, and 4 body acupuncture points. There are three hypothesis for this trial included, first there is a change in the mean pain intensity before the placement of press needles and 24 hours after open spine surgery, following the placement of press needles, in the press needle and medication group at LI4 Hegu, LR3 Taichong, ear acupoint MA TF-1 Shenmen, and MA AT-1 Thalamus compared to the change in mean pain intensity before the placement of sham press needles and 24 hours after open spine surgery, following the placement of sham press needles in the sham press needle and medication group, as measured using the visual analog scale. Second there is a lower mean postoperative pain intensity in the press needle and medication group at LI4 Hegu, LR3 Taichong, ear acupoint MA TF-1 Shenmen, and MA AT-1 Thalamus compared to the sham press needle and medication group, as measured using the visual analog scale at 24 hours and 72 hours after open spine surgery. Third, there is a higher score for postoperative pain management quality in the press needle and medication group at LI4 Hegu, LR3 Taichong, ear point MA TF-1 Shenmen, and MA AT-1 Thalamus compared to the sham press needle and medication group, as assessed using the American Pain Society Patient Outcome Questionnaire Revised questionnaire at 24 hours after open spine surgery The outcome of this research is the intensity of pain scores measured using the visual analog scale assessed prior to press needle acupuncture insertion, 24 hours post-operation, and 72 hours post-operation. Additionally, the quality of postoperative pain management is assessed using the American Pain Society Patient Outcome Questionnaire Revised (APS-POQ-R) at 24 hours post-operation.

NCT ID: NCT06160999 Recruiting - Vaccination Clinical Trials

Improving Uptake of Pediatric Vaccines Through Religious Conferences and Vaccines-in-a-van in Aceh, Indonesia

TABRIE
Start date: September 1, 2023
Phase: N/A
Study type: Interventional

The goal of this cluster, randomized controlled trial is to study the impact of mobile vaccine clinics and religious conferences on pediatric vaccination coverage. The main questions will be: does vaccination coverage change in geographic areas with the mobile vaccine clinics vs those areas without mobile vaccine clinics; and does vaccination coverage change in geographic areas with religious conferences on vaccination vs those areas without religious conferences. In repeated surveys, adult participants will respond about their children's vaccination status. Participants will not be individually randomized to the interventions. Rather, their geographical area will be randomized.

NCT ID: NCT06159179 Recruiting - Clinical trials for Medical Thoracoscopy

Medical Thoracoscopy for Undiagnosed Transudative and Exudative Pleural Effusion

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

Indonesia is one of country that contributes the most cases of tuberculosis worldwide. Tuberculosis is the most commonly etiology of exudative pleural effusion. There have been many studies about undiagnosed exudative pleural effusion, but there are not many studies about the use of medical thoracoscopy for diagnosing transudative and exudative pleural effusion, especially on biomarkers of C-Reactive Protein (CRP), D-dimer, Adenosine Deaminase (ADA), Antinuclear Antibody (ANA), C3 C4 complements, Cancer Antigen 125 (CA-125), Xpert Mycobacterium Tuberculosis (Xpert MTB), Lupus Erythematosus cell (LE cell), cytology (effusion and smear) and histopathology. Information gained from those biomarkers via thoracenthesis and medical troracoscopy, etiology of exudative and transudative pleural effusion can be detected earlier and clearly, especially etiology of infection, autoimmune, and malignancy that further can be used to reduce patients' hospitalization period, mortality, and to develop the new therapeutic agents.

NCT ID: NCT06153134 Recruiting - Melasma Clinical Trials

Curcuma Xanthorriza Roxb. 10% Cream for Melasma

Start date: December 22, 2023
Phase: Early Phase 1
Study type: Interventional

Melasma is an acquired hyperpigmentation disorder with a multifactorial etiology and complex pathogenesis that can significantly diminish the quality of life for affected patients. As of now, melasma therapy remains challenging due to its high recurrence rate and the common occurrence of treatment-related side effects. The use of depigmentation agents is a crucial component in managing melasma. Hydroquinone stands as the first-line depigmentation agent for melasma; however, its use often leads to adverse effects. Therefore, alternative depigmentation agents are needed. Curcuma xanthorriza Roxb., a native plant of Indonesia, operates by inhibiting the tyrosinase enzyme, reducing MITF transcription, and inhibiting α-MSH. Despite these potential benefits, Curcuma xanthorriza Roxb. has not been utilized as a depigmentation agent. Research on the effectiveness of Curcuma xanthorriza Roxb. as a depigmentation agent in melasma treatment has not been conducted. Therefore, it is essential to conduct research to determine the effectiveness of a 10% Curcuma xanthorrhiza Roxb. cream in reducing MASI scores and enhancing skin brightness in epidermal-type melasma.

NCT ID: NCT06152068 Recruiting - Obesity, Adolescent Clinical Trials

Insulin Resistance, Lipid Profile, CRP, IL-18 and Carotid Intima-Media Thickness (CIMT) Diameter in Obese Adolescents

CIMT
Start date: October 1, 2023
Phase:
Study type: Observational [Patient Registry]

Carotid intima-media thickness (CIMT) is a marker for detecting endothelium dysfunction, and has become a non-invasive method that is very useful in detecting and evaluating subclinical atherosclerosis in obese children and adolescents. This method is very useful in visually detecting and monitoring changes in the intima and its medial thickness, and can also evaluate changes within the arterial wall in the absence of localized plaque. Previous research that was conducted found an increase in CIMT diameter in 44 of 59 obese adolescents. Obesity has a risk of increasing the diameter of CIMT which carries the risk of atherosclerosis. Obesity accompanied by insulin resistance, and metabolic syndrome has a greater risk of atherosclerosis. Currently, the prevalence of obesity in adolescents is increasing. Interleukin 18 is a group of interleukin 1 whose levels increase in chronic inflammatory processes such as obesity, metabolic syndrome, and type 2 diabetes mellitus. IL-18 levels increase in obesity with increased CIMT. Assessment of cardiovascular risk in obese adolescents is still a challenge for health practitioners, to prevent cardiovascular complications in obese adolescents which can cause sudden death at a young age. It is necessary to assess changes in the cardiovascular system that can be identified early by knowing the CIMT diameter. However, there is no definite reference value so the CIMT can be used as a reference for the occurrence of subclinical atherosclerosis in obese adolescents. In the previous study, CIMT was not examined in non-obese adolescents, so the cut-off for CIMT in non-obese was not known. Therefore, we have the opportunity to research to determine the thickness of CIMT and determine the cut-off value of CIMT which is at risk of experiencing early atherosclerosis in the obese adolescent population.

NCT ID: NCT06146881 Recruiting - Dry Eye Disease Clinical Trials

Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia

Start date: October 2, 2022
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to determine the effectiveness of preventive therapy with diquafosol sodium 3% compared to sodium hyaluronate 0.1% to prevent dry eye disease in patient who will undergo cataract surgery. The main questions it aims to answer are: - The percentage reduction in subjective symptoms and signs of dry eye disease after cataract surgery. - The differences in the use of diquafosol sodium 3% and sodium hyaluronate 0.1% in improving dry eye disease signs in patients objectively. - The tear osmolarity and matix metalloproteinase-9 (MMP-9) after the treatment. - The difference in visual quality improvement assessed from higher order aberrations (HOA) and contrast sensitivity after administration of diquafosol sodium 3% compared to sodium hyaluronate 0.1%. Participants will receive diquafosol sodium 3% or sodium hyaluronate 0.1% for 4 weeks before the cataract surgery and 21 days after the surgery, and will be: - Interviewed regarding their identity, history of illness, and symptoms of dry eye disease. - Examined by researchers: eye condition, contrast sensitivity using the Pelli-Robson diagram, keratograph, HOA, tear osmolarity, MMP-9, corneal sensitivity, tear break up time (TBUT) , fluorescein break up pattern (FBUP). This examination will be carried out 4 times: on the first day before the research series, four weeks after giving therapy before cataract surgery, 21 days after cataract surgery, and 90 days after cataract surgery.

NCT ID: NCT06145438 Recruiting - Endometriosis Ovary Clinical Trials

Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery

ENDOSafe
Start date: September 4, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to compare safety and efficacy in endometriosis patient after conservative surgery. The main question[s] it aims to answer are: 1. Health-related quality of life (HRQoL) 2. VAS score 3. Beta estradiol 4. TNF Alpha 5. Adnexal mass recurrence Participants will be randomized into 4 groups, each group will receive: 1. Leuprolide Acetate injection/month 2. Dienogest 2 mg/day 3. COC (mycrogynon)/day 4. DMPA injection 150mg/month Researcher will compare the efficacy and safety in the assigned group.

NCT ID: NCT06131554 Recruiting - Clinical trials for Meningococcal Meningitis

A Clinical Trial to Evaluate the Immunogenicity and Safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in Adults Aged 18 to 55 Years

Start date: March 20, 2024
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blinded, positive controlled study to evaluate the lot-to-lot consistency, immunogenicity and safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in adults aged 18 to 55 years. Subjects will be randomized to receive investigational Lot 1, Lot 2, Lot 3 vaccine or control vaccine in a 1:1:1:1 ratio, with the subjects in experimental group randomly and equally assigned to three different batches of MCV4 for single-dose vaccination.

NCT ID: NCT06128694 Recruiting - Cancer, Lung Clinical Trials

Effect of NUTRICAN to Improve Nutritional Status in Cancer Patients

Start date: August 1, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy oral nutrition supplement (ONS) in malnutrition/high risk malnutrition cancer patients. The main questions it aims to answer: 1. Are there differences in knowledge, attitude and behaviour scores in cancer patients who receive cancer-specific ONS compared to those who do not receive cancer-specific ONS? 2. Is there a difference in nutritional status as assessed by average body weight, body mass index (BMI), haemoglobin (Hb), and albumin levels in cancer patients who receive cancer-specific ONS compared to those who do not receive cancer-specific ONS?

NCT ID: NCT06127225 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease (NAFLD)

Proliverenol Supplementation for Non-Alcoholic Fatty Liver Disease (NAFLD)

Start date: April 28, 2023
Phase: Phase 2
Study type: Interventional

This is a 4-arm, prospective, randomized, double-blind, double-dummy, and placebo-controlled clinical study comparing Proliverenol at a dose of 500 mg twice daily; Proliverenol at a dose of 1000 mg once daily; Proliverenol at a dose of 1000 mg twice daily; and Placebo two caplets daily for a 12-week course of therapy. Proliverenol is a bioactive fraction derived from the dried fruit of Phaleria macrocarpa (Scheff.) Boerl (Thymelaeaceae). Proliverenol possesses a hepatoprotective activity via anti-inflammation, DNA repairing, and the antiapoptosis properties. Pre-clinical study of Proliverenol showed that it exerted the hepatoprotective activity through increasing cell survival via: 1) up-regulation of DNA repair enzyme; 2) down-regulation of NF-kB, TNFα and caspase-8 expressions, to prevent ALT leakage in HepG2 cells. Proliverenol repressed ALT expression, which could also be significantly important as possible alternative mechanism for increased blood transaminase activities. Caspase-8 pathway seemed to be involved in the molecular pathway rather than directly inducing mitochondrial damage. Taken together, ethanol induced apoptosis through NF-kB-TNFα-caspase-8 pathway, and Proliverenol protected the cells from the toxicity conditions.