[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Universiti Kebangsaan Malaysia Medical Centre\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":188},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,48,77,109,139,165],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100592960","mechanism-of-fodmap-restriction-on-fgid-patients-100592960",false,"NCT07000227","Mechanism of FODMAP Restriction on FGID Patients","Mechanism of FODMAP Restriction on Gut Microbiota and Gut Barrier Function in Functional Gastrointestinal Disorder Patients : A Randomised Controlled Trial","BRIDGE","Inclusion Criteria:\n\n* Aged 18 and above\n* Able to provide informed consent\n* Those with pre-existing irritable bowel syndrome (IBS) or functional dyspepsia (FD) or both screened by gastroenterologists\n* Meet the ROME III- Asian criteria for FGID\n* Able to communicate in Malay or English language\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* History declared by the participant of pre-existing gastrointestinal disorder, including but not limited to Inflammatory Bowel Disease, Coeliac Disease, Pancreatitis, Gallstone disease (biliary colic, cholecystitis), Diverticulitis\n* Cancer of any kind\n* Patients with reported history of previous resection of any part of the GI tract other than appendix or gall bladder, intestinal stoma\n* Habitual use of opiate analgesics likely to alter bowel function e.g. morphine\n* Use of antibiotics in the preceding two weeks and\u002For in the past one month\n* Consumption of probiotics, prebiotics or fibre supplements in the past one month\n* Enteral feeding or texture modified diet patients\n* Those with cognitive impairment or severe mental disorder (Alzheimer's, schizophrenia, bipolar disorder. etc)\n* Shift workers (e.g. Nurse, doctors)","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","Brief Summary :\n\nThe goal of this clinical trial is to investigate the effects of differing FODMAP diets on gut microbiota, gut barrier function, symptom severity, quality of life, and psychological status in FGID patients. The main question it aims to answer is :\n\nHow does diets with differing FODMAP content affect the gut microbiota, gut barrier function, symptom severity, psychological status and quality of life in patients with FGID ? Researchers will compare low FODMAP diet, Gentle FODMAP diet and Traditional Dietary Advice (NICE guidelines) to see which diet is more suitable and effective for Malaysian FGID patients.\n\nParticipants will :\n\nBe given either low FODMAP diet, Gentle FODMAP diet or Traditional Dietary Advice intervention and will be required to follow the intervention for two weeks.\n\nBe required to provide stool and blood samples during baseline and intervention Record 4 day food diary and complete assessing questionnaires during baseline and intervention",[27,28,29],"Functional Gastrointestinal Disorders (FGIDs)","Irritable Bowel Syndrome (IBS)","Functional Dyspepsia",[31,32,29,33,34],"Functional Gastrointestinal Disorder","Irritable Bowel Syndrome","FODMAP Restriction","Gentle FODMAP","RECRUITING","2026-05-08",{"date":38,"type":39},"2026-05-11","ACTUAL",{"date":41,"type":39},"2025-07-20",{"date":43,"type":21},"2026-09-30",{"name":45,"class":46},"Universiti Kebangsaan Malaysia Medical Centre","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":47},"100628810","phase-2-the-efficacy-of-tocotrienol-rich-fraction-for-liver-protection-in-adult-patients-with-alcoholic-fatty-liver-disease-afld-100628810","NCT07466485","The Efficacy of Tocotrienol Rich Fraction for Liver Protection in Adult Patients With Alcoholic Fatty Liver Disease (AFLD)","The Effect of Palm Tocotrienol Rich Fraction on Alcoholic Fatty Liver Disease (AFLD): A Phase II Clinical Trial","Inclusion Criteria:\n\n1. Patients with history of alcoholic use disorder with clinical and biochemical evidence of alcoholic steatohepatitis (AST:ALT \\>2.0, elevated GGT)\n2. Patients with Maddrey's discriminant function ≤ 32, and do not require the treatment of corticosteroid therapy or pentoxifylline.\n3. Patients aged 18 to 65\n4. Patients who could comply with alcohol abstinence.\n\nExclusion Criteria:\n\n1. Severe alcoholic hepatitis defined as Maddrey's discriminant function \\>32\n2. Patients with other concomitant liver diseases:\n\n   1. Hepatitis B\n   2. Hepatitis C\n   3. Non-alcoholic fatty liver disease (NAFLD)\n   4. Autoimmune hepatitis (AIH)\n   5. Hereditary hemochromatosis\n3. Patients who are obese (a BMI of 30 kg\u002F m2 or more) and with metabolic syndromes\n4. Patients with bleeding disorders and who have been on anticoagulant or antiaggregant treatments\n5. Patients who have been on corticosteroid therapy or pentoxifylline for alcoholic hepatitis\n6. Patients with hepatocellular carcinoma\n7. Pregnant patients\n8. Patients who are breastfeeding\n9. Patients with Childs C liver cirrhosis\n10. Patients who have pyridoxine allergy or history\n11. Patients who are judged by investigator that participation of the study is difficult due to disease as follow; hepatic cirrhosis, Wilson's disease, malignant tumor, serious metabolic disease, severe renal disease, severe pulmonary disease, severe cardiovascular disease, severe nervous disease\u002Fpsychiatric disorder, muscle disease and etc.\n12. Patients taking vitamin E, herbal supplements, or other investigational products within 90 days prior to the participation in the study.\n13. Patients who have been taken any medications that could affect the treatment: hypoglycemic agents, colchicine, penicillamine, corticosteroids, ursodeoxycholic acid, pentoxifylline, long-term use of NSAIDs, statins, neuroleptics, anticonvulsant medications, high-dose acetaminophen(\\>=2.5g\u002Fday)\n14. Patients who have received treatment that may affect liver function within 1 month prior to the participation in the study\n15. Patients who could not comply with alcohol abstinence.\n16. Patient who considered ineligible for participation in the study as Investigator's judgment","65 Years",{"count":57,"type":21},26,[59],"PHASE2","This clinical study aims to explore the potential liver-protective effects of palm tocotrienol-rich fraction (a form of Vitamin E) in adults with alcoholic fatty liver disease (AFLD). A total of 26 participants aged 18 to 65 years with AFLD will be randomly assigned to receive either tocotrienol (200 mg twice daily) or a placebo for six months. Throughout the study, participants will undergo regular liver health assessments including blood tests, FibroScan, and FibroTest, alongside evaluations of oxidative stress and inflammation markers. The study aims to determine whether tocotrienol can help improve liver function and reduce alcohol-related liver damage. Findings from this trial may provide valuable evidence for future clinical studies and highlight the potential of Malaysian palm-based tocotrienol as a natural, supportive approach to liver health.",[62],"Alcoholic Fatty Liver Disease",[64,65,66,67],"Liver diseases","Tocotrienols","Antioxidants","Oxidative stress","NOT_YET_RECRUITING","2026-04-28",{"date":71,"type":39},"2026-04-29",{"date":73,"type":21},"2026-05-02",{"date":75,"type":21},"2027-02-15",{"name":45,"class":46},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":47},"100596158","phase-2-a-study-comparing-different-treatment-approaches-for-the-initiation-of-puberty-in-girls-with-turner-syndrome-using-a-trifecta-dared-approach-for-rare-diseases-100596158","NCT07041814","A Study Comparing Different Treatment Approaches for the Initiation of Puberty in Girls With Turner Syndrome Using a TRIFECTA-DARED Approach for Rare Diseases","Bayesian Pragmatic Trial for Pubertal Induction in Turner Syndrome: TRansformation Initiative For Efficient Clinical TriAl Design Advancement in RarE Diseases (TRIFECTA-DARED Framework)","TRIFECTA-DARED","Inclusion Criteria:\n\n1. Females aged 11-30 years old with karyotype-verified (45, X or other similar karyotypes) and clinically confirmed Turner's syndrome prior at the time of pubertal induction\n2. Confirmed estrogen deficiency with primary ovarian failure (high level of follicular stimulating hormone (FSH \\> 25 IU\u002FL))\n3. Patients who have not undergone pubertal development ( no breast development and underdeveloped uterus size).\n4. Hormone Replacement Therapy (HRT)-naive TS patients\n5. Breast Tanner Stage of 2 or less.\n6. Patients on Growth Hormone (GH) will be allowed entry into the study.\n7. Consented to trial participation (from individual TS patients (if aged 18 and above) or the parents or guardians (for under-18 TS patients) with individual's assent\n\nExclusion Criteria:\n\n1. Patients with signs of spontaneous puberty\n2. Contraindications to trial products (e.g hypersensitivity to any components of the HRT) based on the most recent version of the British National Formulary (BNF 85)\n3. Previous history of exposure to estrogen treatment.\n4. Concomitant use of other drugs that affect the bone mineral density (BMD) of the participants (e.g. Bisphosphonates or prolonged use of systemic corticosteroids). Vitamin D supplementation and short corticosteroid usage are allowed.\n5. Acute or chronic hepatic disease\n6. Patients with untreated hypothyroidism\n7. Inflammatory bowel disease (Ulcerative Colitis, Crohn's disease) and coeliac disease\n8. Cigarette-smoking patients\n9. Severely obese patients based on the following criteria:\n\n   1. For TS patients aged 11-17 years old: Based on the WHO chart with BMI \\> 95th percentile\n   2. For TS patients aged 18 years until 30 years: BMI of 37.5 or above based on the Malaysian Clinical Practice Guideline for the Management of Obesity\n10. Unknown abnormal genital bleeding\n11. Porphyria\n12. Recent involvement with clinical research studies (previous 6 months) investigating new HRT formulations","FEMALE","11 Years","30 Years",{"count":89,"type":21},24,[59],"Turner syndrome is a condition in which a girl's body does not make enough estrogen on its own, so doctors give estrogen to help start breast and uterine (womb) development. Hence, the goal of this clinical trial is to learn whether two different ways of giving estrogen help girls and young women with Turner syndrome go through puberty normally, and to compare how well each method works and how safe they are.\n\nThe main questions the trial aims to answer are:\n\n1. Does taking an oral estrogen tablet (Progynova) or applying an estrogen gel (Oestrogel) lead to better breast development?\n2. Does one method lead to a larger uterine size as seen on ultrasound?\n3. Do participants start menstrual-like (withdrawal) bleeding, and does one method cause it sooner?\n4. What side effects (for example, headaches, nausea, changes in blood tests) happen with each method?\n\nWho can take part?\n\n* Girls and young women aged 11-30 years with a confirmed diagnosis of Turner syndrome and no previous estrogen treatment.\n* They have not yet begun puberty (no breast growth, and a small uterus on ultrasound).\n* They agree to adhere to the study schedule and keep a diary of any bleeding or side effects\n\nWhat will happen to the participants during the clinical trial?\n\n* Get assigned at random to one of two groups (1:1 ratio):\n\n  1. Gel group: Apply Oestrogel (17β-estradiol) to the skin, starting twice a week, then daily with increasing doses over 19 months.\n  2. Tablet group: Swallow Progynova (estradiol valerate) tablets, starting twice a week, then daily with increasing doses over 19 months.\n* Visit the clinic at the start of study (baseline), month 1, 7, 13, and 19 for:\n\n  1. A physical exam (including breast staging).\n  2. An ultrasound to measure uterine length and thickness.\n  3. A blood test for safety checks (triglycerides and other markers).\n  4. Keep a diary noting any spotting or bleeding (called withdrawal bleeding) and any side effects.\n\nWhy does this matter?\n\nGirls and young women with Turner syndrome often need estrogen to begin puberty safely. This trial will show which method-gel or tablets-best mimics natural puberty (breast and uterine growth), how quickly menstrual-like bleeding begins, and which has fewer unwanted effects. The findings will help doctors choose the most effective and safe treatment for people with Turner syndrome.",[93],"Turner Syndrome",[93,95,96,97,98,99,100],"Hormone Replacement Therapy","Progynova","Oestrogel","Transdermal 17β Estradiol","Estradiol Valerate","Pubertal Induction","2026-01-28",{"date":103,"type":39},"2026-02-02",{"date":105,"type":21},"2026-02-15",{"date":107,"type":21},"2029-10-31",{"name":45,"class":46},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":115,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":120,"conditions":121,"keywords":125,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":47},"100492646","phase-1-transdermal-microneedle-lignocaine-delivery-versus-emla-patch-for-topical-analgesia-before-venepuncture-procedure-to-adults-in-clinical-setting-100492646","NCT05694858","Transdermal Microneedle Lignocaine Delivery Versus EMLA Patch for Topical Analgesia Before Venepuncture Procedure To Adults in Clinical Setting","Inclusion Criteria:\n\n* Patients aged 18 years old and above\n* Patients requiring venepuncture for blood investigations before ophthalmological procedures\n\nExclusion Criteria:\n\n* Patient with a previous history of sensitization or allergy to lignocaine.\n* Patient with a previous history of allergy to materials used in the study i.e., plaster, electrodes, maltose, Polyvinyl Alcohol (PVA), and Polyethylene Terephthalate (PET)\n* Patient exposed to analgesic usage within 24 hours prior to the procedure\n* Generalized skin disorder\u002F rash\n* Agitated\u002F fretful \u002F uncooperative patient\n* Uncommunicative\u002Fdeaf\u002Fmute patients\n* Patients on hypnotics, or chronic pain relief medications\n* Patients with psychiatric conditions\n* Patients with hepatic impairment\n* Patients who are on CYP450 3A4, 3A5 or 1A2-inducing or inhibiting drugs (erythromycin, ciprofloxacin, amiodarone etc.) or pharmacotherapeutic agents that affect hepatic blood flow (metoprolol) since both may affect the metabolism of lignocaine\n* Failed first\u002Fsingle attempt at venepuncture after the application of the LEMAP or PET patch for control arm.",true,{"count":117,"type":21},154,[119,59],"PHASE1","Microneedle (MN) is a mimic of a hypodermic needle, composed of hundreds of micron-sized, out-of-plane protrusions, typically arranged in arrays on a patch that can be applied onto the skin. MN can be fabricated from a variety of materials, preferably biocompatible polymers. Maltose, a natural carbohydrate, is a safe and biocompatible product that can be fabricated into MNs that are biodegradable and soluble within several minutes. Besides, local anaesthetic agents such as lignocaine can be impregnated within the MN matrix, facilitating its transdermal delivery more efficiently which results in enhanced efficacy. So far, maltose MN efficacy in enhancing the transdermal drug delivery (TDD) of lignocaine and thus reducing the pain experienced by healthy patients requiring venepuncture prior to routine eye surgeries (phacoemulsification, trabeculectomy etc) has not been extensively studied. Hence, the objectives of this research are: 1) To evaluate the safety profile of lignocaine-embedded microneedle patch as a means of pain reduction in adult patients requiring routine vein-puncturing procedures; 2) To assess the pharmacokinetic (PK) parameters of lignocaine in the systemic circulation when the transdermal lignocaine delivery is enhanced through microneedle usage; 3) To compare the efficacy of lignocaine-embedded microneedle patch with standard 5% Eutectic Mixture of Local Anesthetics (EMLA) dermal patch for pain reduction during venepuncture procedure based on mean changes in VAS scores and skin algesimeter index (pharmacodynamic (PD) study).",[122,123,124],"Glaucoma","Cataract","Ophthalmological Disorder",[126,127,128,129,123,122,130],"Microneedle","Maltose Microneedle","EMLA","EMLA-impregnated microneedle","Venepuncture","2025-07-15",{"date":133,"type":39},"2025-07-18",{"date":135,"type":39},"2025-02-17",{"date":137,"type":21},"2026-12-11",{"name":45,"class":46},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":115,"sex":17,"minAge":18,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":149,"phases":4,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":47},"100552437","effect-of-placing-the-endotracheal-tube-beyond-cervical-c7-level-in-anterior-cervical-decompression-and-fusion-surgery-100552437","NCT06473077","Effect of Placing the Endotracheal Tube Beyond Cervical C7 Level in Anterior Cervical Decompression and Fusion Surgery","Effect of Placing the Endotracheal Tube Beyond Cervical C7 Level in Anterior Cervical Decompression and Fusion Surgery: An Observational Study On Endotracheal Cuff Pressure Changes","Inclusion Criteria:\n\n1. ACDF surgery\n2. Age between 18-80 years\n3. ASA I, II or III\n\nExclusion Criteria:\n\n1. Patients who is already ventilated prior to ACDF surgery\n2. Anatomical deformity in the neck\n3. Pre-existing sore throat, dysphagia, hoarseness of voice","80 Years",{"count":148,"type":21},16,"OBSERVATIONAL","Endotracheal intubation is performed to secure the patient's airway during general anaesthesia undergoing surgery. The procedure involves placing a tube known as endotracheal tube (ETT) mouth into the trachea. The ETT usually has a cuff at the distal part of the tube which functions as a seal to the trachea for proper delivery serves as protection against the ingress of pathogens and fluids from the pharyngeal space into the lower airways. During intubation, the cuff usually positioned just beyond the vocal cord which is anatomically situated at cervical vertebrae C5 to C6 in adult. After intubation, the endotracheal cuff pressure (ETCP) is checked once or intermittently and kept within appropriate range as cuff overinflation can cause complications that range from mild sore throat to tracheal ischemia, tracheal rupture and fistula formation. The recommended range for ETCP is between 20 to 30 cm H2O. For surgeries performed on head and neck region, the monitoring of ETCP is difficult as this might intrude into the sterile surgical field. Anterior decompression and fusion (ACDF) surgery is commonly performed to treat cervical spine issues such as herniated discs, spinal stenosis, or degenerative disc disease. During ACDF, the surgeon accesses the cervical spine from the anterior of the neck by moving aside the soft tissues to gain access to the spine. While doing this, a surgical retractor is often used to hold the tissues aside carotid sheath laterally, and the trachea and the oesophagus medially. Placement of a retractor during ACDF may inadvertently lead to compression or pressure on the conventionaly placed ETT resulted in rise in ETCP as high as 50 mmHg and causes airway complications such as dysphagia, sore throat and dysphonia. We hypothesize by positioning the endotracheal cuff deeper beyond the cervical vertebrae C7 would not cause significant rise in ETCP during retractor placement based on the assumption that the surgical retractor would not directly compress on the cuff. The investigators designed this study to observe ETCP changes before and after retractor placement and associated complication.",[152],"Anterior Spinal Artery Compression Syndromes, Cervical Region",[154,155,156],"ENDOTRACHEAL CUFF PRESSURE CHANGES","ANTERIOR CERVICAL DECOMPRESSION AND FUSION SURGERY","CONTINUOUS ENDOTRACHEAL CUFF PRESSURE MONITOR","2024-06-18",{"date":159,"type":39},"2024-06-25",{"date":161,"type":21},"2024-06-24",{"date":163,"type":21},"2025-05-31",{"name":45,"class":46},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":115,"sex":17,"minAge":172,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":47},"100400115","phase-4-evaluation-of-ketamine-as-sedative-agent-in-endoscopic-retrograde-cholangiopancreatography-ercp-100400115","NCT04490031","Evaluation of Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)","Randomized Control Study Evaluating Ketamine as Sedative Agent in Endoscopic Retrograde Cholangiopancreatography (ERCP)","Inclusion Criteria:\n\n* Malaysian citizens of who is able to give valid consent\n* Patient planned for ERCP (either emergency or elective)\n\nExclusion Criteria:\n\n* Known hypersensitivity towards Ketamine or Midazolam\n* Patient refusal to participate or unable to give consent\n* Increased intracranial pressure, acute stroke (\\\u003C3 months), intracranial haemorrhage (\\\u003C3 months)\n* Uncontrolled hypertension (BP\\>160\u002F100) and tachycardia (Heart rate \\>120)\n* Acute myocardial infarction, acute coronary syndrome (\\\u003C3 months)\n* Tachyarrythmia\n* Pregnancy\n* IVDU or substance abuse patient\n* Patient with history of hallucination\n* Child's Pugh Class C","16 Years",{"count":174,"type":21},140,[176],"PHASE4","This is a study evaluating the usage of Ketamine as sedative agent in ERCP. The usage of Ketamine will be compared to the standard sedation in our center, which is Midazolam in combination with Pethidine as analgesia.",[179],"Ketamine Adverse Reaction","2020-07-24",{"date":182,"type":39},"2020-07-28",{"date":184,"type":39},"2020-03-01",{"date":186,"type":21},"2021-04-30",{"name":45,"class":46},""]