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NCT ID: NCT04439981 Completed - Athletes Foot Clinical Trials

Curcuma Extract Beneficial for Muscle Damage

Start date: April 8, 2019
Phase: N/A
Study type: Interventional

Muscle damage and inflammation is a clinical problem caused by the unimpeachable body adaptation of strenuous exercise through increasing free radicals. Antioxidants content in Curcuma is hypothesized to alleviate the free radicals. This study aimed to examine the effect of Curcuma extract in the form of ice cream to improve muscle damage and inflammation of soccer athletes caused by strenuous exercise. This study was experimental study with pre-post control group design. Male soccer athlete (n=20) were divided into treatment group (n=10) and control group (n=10). The treatment group was treated by Curcuma extract ice cream for 21 days. Blood samples of creatine kinase (as muscle damage marker) and IL-6 (as inflammation marker) were quantified.

NCT ID: NCT04435925 Completed - Anesthesia Clinical Trials

Inflammatory Effect Comparison Between Fentanyl and Remifentanil in Mastectomy Under General Anesthesia

Start date: July 27, 2020
Phase: N/A
Study type: Interventional

Mastectomy triggers stress and inflammation responses due to tissue trauma. Surgical stress will increase levels of hormones (adrenocorticotropic hormone, cortisol, antidiuretic hormone, epinephrine, norepinephrine, and dopamine) and inflammatory cytokines (Tumor Necrotic Factor-α, interleukin-1, interleukin-2, and interleukin-6) in the body. This causes insulin resistance, gluconeogenesis, and glycolysis, and impaired insulin secretion, which results in hyperglycemia due to intraoperative stress. Intraoperative hyperglycemia increases postoperative complications and mortality. Inhibition of hyperglycemia due to operative stress and stress hormones with good anesthetic management in improving patient outcomes. The choice of opioid type plays an important role in suppressing the perioperative stress and inflammatory response. Opioids are an alternative, besides the use of regional anesthetic techniques which have been proven to suppress the perioperative stress response. Fentanyl is one of the phenylpiperidine synthetic opioids. Large doses of fentanyl can reduce stress responses but also increase side effects, such as hemodynamic instability and decrease T-cell function. Remifentanil provides unique pharmacokinetic benefits through nonspecific esterase enzyme metabolism, so it has a very fast onset and half-life. In addition, remifentanil also provides benefits in reducing the production of interleukin 6 cytokines (IL-6) and tumor necrosis factor α (TNF-α) and inhibits neutrophil migration through the endothelial layer. The stress response to stress and inflammation is directly proportional to the dose of remifentanil given. It is reported that remifentanil can suppress cortisol response according to increasing dose. Winterhalter et al. and Lee et al. reported that remifentanil is better at suppressing the stress response than fentanyl. On the other hand, Bell et al. showed no difference in cortisol and hemodynamic levels between the two groups. The goal of this study is to see if remifentanil provides less increase in serum epinephrine level, norepinephrine level, platelet to lymphocyte ratio (PLR), lymphocyte to monocyte ratio (LMR), and blood glucose level at one-hour and 24-hours postoperative in patients undergoing mastectomy surgery under general anesthesia.

NCT ID: NCT04434430 Completed - Clinical trials for Non-obstetric Lower Abdominal Surgery

Preemptive Oral Gabapentin 600 mg in Reducing Morphine Requirement After Non Obstetric Lower Abdominal Surgery

Start date: November 11, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This study aimed to get the information about the effectiveness of preemptive oral gabapentin 600 mg in reducing morphine requirement after non obstetric lower abdominal surgery

NCT ID: NCT04431063 Completed - Clinical trials for Rupture of Anterior Cruciate Ligament

Comparison of the Functional Outcome of Site Peroneus Longus Graft Donors With and Without Distal Stump Suturing of Peroneus Tendon Brevis on ACL Reconstruction Case in Cipto Mangunkusumo Hospital in Jakarta With 24 Patient as Subject Who Will Divide Into 2 Group.

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

Injury of the Anterior Cruciate Ligament (ACL) is one of the most common sports injuries. The incidence rate reaches 68.6 cases per 100,000 people per year. Management of ACL injuries for individuals who want to return to the level of exercise activity as before, mostly in the form of reconstructive surgery. As many as 60,000 to 175,000 cases of ACL reconstruction per year are carried out in the United States At present, many reconstructive surgeries are performed by taking tendon grafts on the patient's own body (autograft) to then be used instead of the ACL. The most widely used graft sources are Hamstring and Bone-Patellar Tendon-Bone (BPTB) grafts. Other alternative grafts are Quadriceps tendon, Fascia Lata, Iliotibial Band, and Peroneus Longus Tendon. Each graft retrieval technique has advantages and disadvantages. BPTB graft has the best tensile strength and bone union with bone, but the complications of anterior knee pain are also quite common (5-55%). Hamstring grafts and Quadriceps grafts minimize the complications of anterior knee pain, with fairly good tensile strength, but the union of grafts with bone takes longer. The loss of Hamstring tendons also causes a decrease in muscle strength in Hamstring, where Hamstring has an important role in preventing the anterior translation of the tibia Peroneus Longus Tendon graft is an alternative graft developed to minimize complications associated with graft use from the area around the knee. Peroneus Longus tendons also have tensile strength similar to Hamstring tendons. As with other graft extracts, Peroneus Longus tendon graft is also accompanied by complications in the donor site. Possible complications arising from the loss of the Peroneus Longus tendon include ankle instability and decreased flexion strength of the 1st ray and ankle eversion. Research carried out by Bancha et al showed a reduction in flexion strength of 1st ray and ankle eversion significantly, without any instability in the ankle. Peroneus longus provides 5.5% strength for moderate dorsiflexion for ankle eversion movements, peroneus longus is the main muscle. But in other studies it is said that the use of peroneus longus graft does not interfere with the stability of the ankle and ROM. Does not even affect the functional outcome of the ankle However, in a study conducted by Bancha et al and Kerimoglu et al., The technique used for taking Peroneus Longus graft tendons did not include suturing in the distal stump of Peroneous Longus. So with this study, researchers wanted to find out whether different results would be found related to donor site complications if the technique used included suturing the distal stump of the Peroneus Longus tendon against the peroneus brevis tendon

NCT ID: NCT04425109 Completed - Weight Loss Clinical Trials

The Effect of Fermented and Non-fermented Soy Based Food in Appetite and Satiety Biomarker Among Young Obesity

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

Limited data are available regarding the satiety effects from fermented and non-fermented soy-based food. The aim of this study was to compare fermented (tempeh) and non-fermented soy-based diets high in protein in increasing satiety. Thirteen young obese females were studied in single-blind and cross over design. Blood samples were assessed frequently for 0, 30 and 120 minutes after consumption of two isocaloric breakfast which consist of tempeh and non-fermented soybean content. The energy content was 27% protein, 21% fat and 52% carbohydrate. Subjective satiety score was recorded at 30 and 120 minutes after taking a meal. Compared to non-fermented soybean, tempeh showed a steady trend in postprandial ghrelin, significantly increasing insulin and arginine, and decreasing glucose at 120 minutes. Satiety scores had the same trend in the hunger and fullness aspects between the meals.

NCT ID: NCT04418089 Completed - Breast Cancer Clinical Trials

Simvastatin Effect in Combination With Neoadjuvant Chemotherapy to Clinical Response and Tumor-Free Margin in Locally Advanced Breast Cancer

Start date: January 15, 2018
Phase: Phase 2
Study type: Interventional

Introduction: Neoadjuvant chemotherapy (NACT) has been the standard therapy for treating patients with locally advanced breast cancer (LABC). Doxorubicin-based regimen showed a clinical response for 70-80%. However, the cardiotoxicity from it was not tolerable. Simvastatin acts synergistically with doxorubicin against MCF-7 cells, through downregulation of the cell cycle or induction of apoptosis. Also, it alleviates doxorubicin cardiotoxicity by attenuating ER stress and activating the Akt pathway. Hmgcris a new pathway mediating doxorubicin-induced cell death, and cholesterol control drugs combined with doxorubicin could enhance efficacy and reduce side effects. This study is conducted to see the combination simvastatin and CAF would increase the NACT response and surgical margin of LABC patients. Methods: This study was a double-blind, randomized placebo-controlled trial, conducted in dr. Cipto Mangunkusumo General Hospital and Koja General Hospital. A total of 70 LABC patients were assessed for eligibility. Patients received either a combination of CAF-Simvastatin (40 mg/day) or CAF-Placebo. The biopsy was taken pre-NACT to make the histopathological diagnosis and examine the expression of HMG-CoA Reductase (Hmgcr) and P-glycoprotein (P-gp). Patients were evaluated for the clinical response after 3 cycles. If the response was positive, patients will proceed to surgery. Then, the post-operative specimen will be reviewed for the pathological response. However, if it was a negative response, patients will be given 2nd line NACT.

NCT ID: NCT04416880 Completed - Clinical trials for Lactation; Insufficient, Partial

Effectiveness of Press Tack Needle Acupuncture in Treating Lactation Insufficiency

Start date: December 13, 2019
Phase: N/A
Study type: Interventional

This study was meant to see the effectiveness of press tack needle acupuncture in improving lactation insufficiency. The acupuncture points used in this study were CV17 Danzhong and SI1 Shaoze. Press Tack Needles were placed in these acupuncture points for 7 days in hope that it will give continuous acupuncture stimulation that might help in improving lactation insufficiency with minimal side effect, less time consuming, and more efficient for the patient.

NCT ID: NCT04415034 Completed - Pruritus Clinical Trials

Scalp Pruritus Measurement Using Visual Analog Scale and 5-d Itch Scale in Children With Pediculosis Capitis

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

Pediculosis capitis is a parasitic infestation that can cause scalp pruritus and quality of life disturbances. There are two objective measurement for pruritus, visual analog scale (VAS) and 5-D itch scale, which can assess the severity of the scalp pruritus and the latter can also asses the quality of life affected by pruritus. Even though VAS can not be used to evaluate the impact of pruritus on quality of life, it is very easy to use while 5-D itch scale is complex and not child-friendly. The aim of this study is to determine the relationship between two different pruritus scales and to establish validity of pruritus VAS scale in evaluating quality of life in children with pediculosis capitis. We compare two pruritus scale on students with pediculosis of two boarding school in Bogor, West Java, Indonesia.

NCT ID: NCT04414995 Completed - Analgesia Clinical Trials

Effect of Paracetamol and Ibuprofen Reducing Morphine Requirements After Total Knee Arthroplasty

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Start date: June 5, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Adequate pain management has an important role in supporting early ambulation after the Total Knee Arthroplasty (TKA). Multimodal analgesia is one of the modalities of overcoming postoperative pain. The use of combination Paracetamol and Ibuprofen injection is expected to reduce total morphine consumption after TKA.

NCT ID: NCT04407208 Completed - Clinical trials for Corona Virus Infection

Convalescent Plasma Therapy in Patients With COVID-19

Start date: May 1, 2020
Phase: Phase 1
Study type: Interventional

Scientists and medical workers all around the world were running out of time to manage COVID-19. Several studies have been done to understand the disease and ultimately to find possible treatment. Based on those studies, one of the potential treatment was antibody transfer from recovered COVID-19 patients. Passive antibody transfer was a fast and easy choice. The rational use of antibody from the patient's plasma is a natural neutralizing protein to the cell-infected virus and could possibly slow the active infection down. Investigators initiate an intervention study with purposes to produce quality convalescent plasma from the recovered patients, define the safety of plasma for human use and as an alternative treatment to improve the clinical outcomes of severe COVID-19 patients. The study hypothesis is convalescent plasma is safe and could possibly improve outcome of severe (non-critical) COVID-19 patients. This research will conduct the plaque reduction neutralizing test (PRNT) of recipient blood in vitro. The plasma will be collected in the blood transfusion unit (BTU) in Gatot Soebroto hospital. The storage, testing, transfer, and transfusion of eligible convalescent plasma are the authority of Gatot Soebroto BTU. PRNT and plasma antibody titer measurement from donor plasma will be conducted at Eijkman Institute of Molecular Biology. Investigators enroll approximately 10 patients consecutively, who will be admitted at Gatot Soebroto hospital. Baseline demographic characteristics of samples are recorded. Clinical dan laboratory data will be measured before and after plasma transfusion periodically. The measured variables are pharmacological therapy (antivirus, antibiotics, steroids), invasive oxygen therapy, oxygen index, sequential organ failure assessment (SOFA) score, and laboratory parameters such as leukocyte count, blood chemical panel include liver and renal function, C-reactive protein, procalcitonin, IL-6 and immunoglobulin titer of the recipient and also chest X-ray evaluation. The potential expected risk of plasma transfusions is transfusion reaction (immunological or non-immune related) and transferred foreign pathogen. Investigator will report and treat all adverse events after plasma transfusion has been done. A severe adverse event (SAE) will also report in a special form to sponsor and data safety monitoring board (DSMB). There is theoretically antibody-dependent enhancement (ADE) mechanism from COVID-19 whom will receive plasma transfusion to progress to severe immune response. This preliminary study is supposed to provide supporting data and experience of plasma processing to a larger study in the near future.