[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Aga Khan University Hospital, Pakistan\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":165},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,82,108,133],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100406408","impact-of-mobile-health-technology-application-on-proximal-humerus-fracture-care-practice-100406408",false,"NCT04572022","Impact of Mobile Health Technology Application on Proximal Humerus Fracture Care Practice","Impact of Mobile Health Technology Application on Proximal Humerus Fracture Care Practice and Patient Self-Care Outcomes - A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Trauma associated proximal humerus fractures, presented at orthopaedic inpatient and outpatient units at Aga Khan University Hospital.\n* Patient and\u002For their care providers are voluntarily willing to follow the rehabilitation instructions via mobile application at home until completion of study follow up visits.\n* Patient agree to participate in very small survey questionnaire in the end of study.\n\nExclusion Criteria:\n\n* Patients who in special circumstances requiring special care and handling by expert health care providers.\n* Patient not willing to participate\u002Fexercise at home without physiotherapist support or to participate in survey questionnaire.\n* Patients who does not have facility of classic blue tooth connectivity for video download.","ALL","18 Years","58 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","Proximal humerus fracture patient's upper limb complete function restoration mainly depends on patient rehabilitation exercises. One time teaching in clinic is usually not sufficient for patients to learn their rehabilitation exercises. This leads to delayed patient recovery and dis-satisfaction to treatment provided by health care providers.\n\nOur aim is that mobile health technology might facilitate patient to easily access health related teaching information other than routine care to support patient in their self-health care management thus leading to proximal humerus fracture patient treatment outcome improvement.\n\nHypothesis:\n\nMobile health technology positively improves clinical and functional outcomes of proximal humerus fracture using validated outcome scoring scales.\n\nObjectives:\n\nPrimary objective:\n\n1. To improve adult proximal humerus fracture patient's clinical and functional outcomes using validated outcome scoring scales resulting in timely recovery with the help of patient self-health care capacity using mobile health app.\n2. To compare patient clinical and functional outcomes by validated scoring scales between using mobile health app versus standard care.\n\nSecondary Objective: To increase patient and doctor satisfaction rate in perspective with treatment provision usefully by digital technology application.\n\nMethods:\n\nStudy design: Patient-centered, open labelled, parallel (1:1), pilot randomized controlled trial.\n\nTotal 60 subjects required with 30 in each arm in 24-month duration.\n\nStudy procedures:\n\n1. Proximal humerus rehabilitation exercises video will be prepared after obtaining written informed consent from designated orthopaedic residents\u002Fsurgeon.\n2. Patients of 18 to 58 years of age with trauma associated proximal humerus fractures, who or their attendants are willing to participate. Patients who requires special care, patient not willing to exercise at home without physiotherapist support or participate in survey questionnaire and patients who does not have facility of classic blue tooth connectivity will be excluded.\n3. Written informed consent will be administered the study subjects as per GCP guideline.\n4. Each eligible patient will be randomized into intervention or control group.\n\n   1. Intervention group: Classic Blue tooth technology will be utilized for interoperable solution of teaching video information sharing from doctor to patient. The end users will be enrolled trauma associated proximal humerus fracture patients whether treated surgically or conservatively.\n   2. Control group: Routine care will be provided to control group and as per routine.\n5. The patient will be followed at 6 weeks, 3 and 6 months. Data will be collected on Case report form by assigned person. Clinical and functional outcomes will be assessed by assigned person using Quick DASH and Oxford shoulder score.\n6. Researchers will be trained on data collection form prior to data collection. In case of lost to follow-up, patients will be contacted by telephone.\n7. Patient satisfaction questionnaire: Administered to intervention group only about impact of digital technology application on their health improvement and care outcomes.\n8. Doctor satisfaction questionnaire: To assess treating surgeon satisfaction rate for digital technology application impact on intervention group patients' care and outcomes.\n9. The research study does not seem to have any potential health hazard. As per Food and Drug Administration and GCP recommendations for Serious\u002FAdverse event (SAE\u002FAE), any patient who experience SAE\u002FAE, will receive good clinical care at earliest and all relevant reporting bodies will be notified.\n10. Data management will be carried out at the Department of Surgery. Subject data confidentiality will be maintained. After study completion, data will be archived and retained for maximum years.\n\nStatistical Consideration:\n\nQuantitative variables will be expressed as mean ± standard deviation and qualitative variables as frequencies (percentages). The efficacy on the basis of clinical and functional outcome and the AEs\u002FSAEs will be assessed by intention to treat analysis. For group comparisons of clinical and functional categorical outcomes, chi-square test or Fisher Exact will be applied. p-values of less than 0.05 will be considered as statistically significant with a confidence interval of 95%.\n\nPatient and doctor satisfaction scores will be analyzed using regression analysis. For Assessment of outcomes, repeated measure ANOVA and generalized estimating equation will be used. Multiple regression will be used to assess the association between multiple covariates.",[27,28],"Proximal Humerus Fracture","Trauma",[27,30,31,32],"mobile Health application","rehabilitation exercises","patient teaching video modules","NOT_YET_RECRUITING","2025-09-30",{"date":36,"type":37},"2025-10-01","ACTUAL",{"date":39,"type":21},"2026-12",{"date":41,"type":21},"2027-12",{"name":43,"class":44},"Aga Khan University Hospital, Pakistan","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":65,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100604729","assessing-bone-fracture-healing-effect-of-almonds-100604729","NCT07153302","Assessing Bone Fracture Healing Effect of Almonds","Assessing Bone Fracture Healing Effect of Prunus Dulcis (Almonds) - A Randomized Controlled Trial","AFHEA","Inclusion Criteria:\n\n1. Patients of 18 to 55 years of age of any gender.\n2. Agree and able to voluntary participate.\n3. Patients with trauma associated femur fracture and tibia shaft fracture arriving at hospital for treatment.\n\nExclusion Criteria:\n\n1. Mentally retarded or patients with severe psychiatric illness.\n2. Patients are already on bone-strengthening drugs (bisphosphonates, vitamin D, strontium ranelate, teriparatide, etc.).\n3. Patients who require bone-strengthening drugs for osteoporosis or for any urgent need.\n4. Severe cardiovascular, hepatic, or renal disease.\n5. Known allergy or toxicity to Prunus dulcis (almonds) and\u002For vitamin D supplements.","55 Years",{"count":55,"type":21},136,[24],"Femur and tibia shaft fractures are common after trauma with a burden of 5% and 20% respectively. Clinicians recommend costly bone strengthening drugs\u002Fsupplements while treating bone fractures. These drugs have side effects and are costly due to which patients skip these supplements. Routinely prescribed vitamin D have known toxicity. To overcome this problem, affordable and safe alternative treatment is needed. Sweet almonds contain essential bone nutrients that might have potential for maintaining bone strength. Human and animal studies have shown positive impact of almonds on bone health and fracture healing. Almonds are consumed in diet frequently but may occasionally cause toxicity, mainly if consumed at higher amount. Because of the high bone essential nutrients in almonds, the trial aimed to investigate the fracture healing effect and safety of almonds in femur and tibia shaft fractures. This might provide an alternate option for bone supplants while treating fractures.\n\nHypothesis: Compared to routine vitamin D3, almonds non-inferiorly improves fracture callus index and raise vitamin D3 level in blood in femur and tibia shaft fracture patients.\n\nPrimary Objectives:\n\n1. To compare tibia and femur shaft fracture callus index and callus bridging on x-rays at 4 and 13 weeks herewith group 1 suffering vitamin D insufficiency (arm A versus arm B) and group 2 suffering vitamin D deficiency (arm B versus arm C) treated as cross-over with oral whole almonds and vitamin D3.\n2. To compare the incidence of adverse events between almonds and vitamin D3 treatments up to 13 weeks follow-up.\n\nSecondary Objectives:\n\n1. To compare the almonds and vitamin D3 treatment cost.\n2. To compare within group blood vitamin D levels (ng\u002FmL) at baseline and post-treatment follow-ups.\n\nMethods:\n\nStudy design: Single-center, open-labeled, crossover, non-inferiority randomized controlled trial.\n\nTotal 136 subjects are required with 14 subjects in group 1 and 122 in group 2.in 24-month duration.\n\nStudy procedures:\n\n1. Regulatory and Ethical approvals.\n2. Patient screening and eligibility assessment. Patients, of 18 to 55 years of age of any gender, with trauma associated femur and tibia shaft fractures who agree to voluntary participate are included and mentally retarded or patients with severe psychiatric illness, already on or require bone-strengthening drugs , having severe cardiovascular, hepatic, or renal disease, known allergy\u002Ftoxicity to almonds and\u002For vitamin D supplements.\n3. Written informed consent administration.\n4. Randomization Patients (N=136) are divided into two groups. Group 1 (N=14, vitamin D insufficiency, blood vitamin D level 21-29 ng\u002FmL) and Group 2 (N=122, vitamin D deficiency, blood vitamin D level ≤20 ng\u002FmL).\n\n   I. Group 1 (N=14):\n\n   Arm A (n=7)=5 grams\u002Fday of almonds for 4 weeks, followed by 7 days washout period and cross-over treatment by oral vitamin D3 200,000 units\u002Fweek for 8 weeks.\n\n   Arm B (n=7)=Oral vitamin D3 200,000 units\u002Fweek for 8 weeks, followed by 7 days washout period and cross-over treatment by 5 grams\u002Fday of almonds for 4 weeks\n\n   II. Group 2 (N=122):\n\n   Arm B (n=61)=Oral vitamin D3 200,000 units\u002Fweek for 8 weeks, followed by 7 days washout period and cross-over treatment by 5 grams\u002Fday of almonds for 4 weeks.\n\n   Arm C (n=61)=Oral vitamin D3 200,000 units\u002Fweek together with 5 grams\u002Fday almonds for 4 weeks, followed by 7 days washout period and cross-over treatment by oral vitamin D3 200,000 units\u002Fweek for 8 weeks.\n5. Patients are followed at 4 weeks and 13 weeks follow-ups after treatment.\n6. Fracture site routine X-rays and RUST scores are assessed by treating surgeon\u002Finvestigator(s) at follow-ups for bone fracture healing.\n7. Investigational product (IP) safety assessment and reporting as per ICH-GCP guidelines. Subjects experiencing any adverse event (AE)\u002Fserious adverse event (SAE) is provided optimum care at earliest. All relevant reporting bodies are notified within recommended timeline.\n8. The almonds are regularly purchased from the Purchase Department of the Hospital, weighted, packaged and labelled, and stored at the secure dry hygienic place. The product is dispensed to the patient and a daily IP diary is provided for compliance.\n9. Patients can withdraw from the study at any time without losing any of his\u002Fher patient rights.\n10. Study close-out process will be of one to two-month duration.\n\nStatistical analysis:\n\nThe SPSS version 19.0 will be used to analyze data. Quantitative variables will be expressed as mean±SD\u002Fmedian (IQR) and qualitative as frequencies (%). IP related AEs\u002FSAEs will be assessed by incidence\u002Fstratification. Witin group and within arm comparisons for the radiological assessments and vitamin D3 level will be analyzed by ANOVA and GEE. Within arm tibia and femur fracture outcomes will be compared by independent t-test\u002FMann Whitney U test. The p-value \\\u003C0.05 is considered significant. Multiple regression analysis for association of covariates and outcome will be used.",[59,60,61,62,63,64],"Femur Shaft Fracture","Tibia Fractures","Vitamin D","Sweet Almonds","Callus Index","Callus Bridging",[66,67,68,69,70,71],"callus bridging","callus index","femur shaft fracture","tibia shaft fracture","Prunus dulcis (almonds)","vitamin D3","RECRUITING","2025-08-30",{"date":75,"type":37},"2025-09-03",{"date":77,"type":37},"2024-08-20",{"date":79,"type":21},"2026-07",{"name":43,"class":44},1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":16,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":81},"100601177","comparison-of-periodontal-health-bonding-time-and-failure-between-direct-and-indirect-fixed-retainer-placement-among-orthodontic-patients-100601177","NCT07107100","Comparison of Periodontal Health, Bonding Time and Failure Between Direct and Indirect Fixed Retainer Placement Among Orthodontic Patients","Comparison of Periodontal Health, Bonding Time and Failure Between Direct and Indirect Fixed Retainer Placement Among Orthodontic Patients - A Modified Split-mouth Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged between 18 - 40 years\n* Patients who read, write and understand English language\n* Patients undergoing fixed orthodontic treatment\n* Patients with good oral hygiene, with grade 1 or below on plaque and gingival indices at the time of debonding of brackets.\n* All patients who will sign the informed consent form\n\nExclusion Criteria:\n\n* Patients with periodontal disease\n* Patients with any systemic disease\n* Pregnant or nursing females\n* Patients who cannot come for follow up appointments for a retainer check up",true,"13 Years","40 Years",{"count":93,"type":21},30,[24],"The placement technique of retainers in both maxillary and mandibular arches can influence the time taken for bonding the retainer in the mouth of a patient which can in turn affect the patient´s response to the procedure. The different placement techniques can influence the stability of the retainer wire on teeth and the maintenance of periodontal health during the retention period. Therefore, it is essential to know which technique is better suited for placement and its influence on periodontal health so that in the future it helps clinicians save their time during placement of retainers while benefiting the patients. To our knowledge, this will be the first study both locally and internationally that will include an assessment of periodontal health, time duration of placement and stability of fixed retainer in the maxillary arch as well. Three months period is sufficient for assessment of periodontal health and failure of retainer, long term studies can be at a risk of attrition bias.\n\nOBJECTIVES:\n\nThe objectives of this study are:\n\n* The primary objective of this study is to compare the failure of fixed retainers, along with periodontal health and bonding time, which are bonded either through direct method or indirect method on patients undergoing orthodontic debonding through a modified split-mouth technique using mean values for plaque index, gingival index, calculus index follow up appointments over a period of three months.\n* The secondary objective of the study is to assess the amount of time taken during placement of retainers via both direct and indirect bonding of fixed retainers",[97],"Orthodontic Treatment",[99],"fixed retainer, retainer breakage","2025-07-30",{"date":102,"type":37},"2025-08-06",{"date":104,"type":37},"2024-01-01",{"date":106,"type":21},"2025-08-21",{"name":43,"class":44},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":81},"100597261","impact-of-verbal-compared-to-structured-information-on-patients-anxiety-and-satisfaction-undergoing-uroflowmetry-100597261","NCT07056192","Impact of Verbal Compared to Structured Information on Patient's Anxiety and Satisfaction Undergoing Uroflowmetry","Inclusion Criteria:\n\n1. Age 18 years and above\n2. Undergoing uroflowmetry for the first time\n3. Patients, who can hear, read and comprehend the education in either Urdu or English language.\n\nExclusion Criteria:\n\n1. Language barrier\n2. Known psychiatric illness\n3. Unable to comprehend instructions due to any neurological issue\n4. Unable to void adequate volume even after 3 attempts",{"count":115,"type":21},132,[24],"Background: Uroflowmetry (UFM) is a non-invasive initial, simple, and widely performed first-line investigation for the evaluation of lower urinary tract symptoms. Despite its non-invasive nature, uroflowmetry can provoke anxiety and affect satisfaction, often due to misunderstandings about the procedure.\n\nObjective: This randomized control trial aimed to compare the effects of structured versus verbal education on anxiety and satisfaction in patients undergoing uroflowmetry.\n\nMethodology: A single-blind, parallel-arm study will include 48 patients, which will be randomized into structured (brochure) and verbal counseling groups. The modified Amsterdam Preoperative Anxiety and Information Scale (APAIS-M) will assess anxiety, while satisfaction will be measured by using a questionnaire adapted from Dogun et al. Descriptive statistics, Chi-square, and independent t-tests will be employed for data analysis in spss 23.",[119,120],"Anxiety","Satisfaction",[122,119,123,124,120],"Uroflowmetry","Verbal education","Structured information","2025-07-09",{"date":127,"type":37},"2025-07-11",{"date":129,"type":37},"2025-01-01",{"date":131,"type":21},"2025-07-15",{"name":43,"class":44},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":89,"sex":16,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":147,"conditions":148,"keywords":152,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":81},"100558011","phase-3-prevention-of-metabolic-acidosis-in-preterm-neonates-by-replacing-sodium-chloride-with-sodium-acetate-in-parenteral-nutrition-100558011","NCT06545565","Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition","Prevention of Metabolic Acidosis in Preterm Neonates by Replacing Sodium Chloride With Sodium Acetate in Parenteral Nutrition - A Randomized Controlled Trial. (PROTECT Trial)","PROTECT","Inclusion Criteria:\n\n1. Written informed consent obtained by parents\u002Flegal representative (according to local regulations) before the initiation of PN.\n2. All the neonates who were admitted to the NICU of AKUH and received PN during 28 days of their life.\n3. Gestational age \\\u003C 33 weeks\n\nExclusion Criteria:\n\n1. Infants with an inborn error of metabolism\n2. Genetic or congenital condition that affects neurodevelopment or requires multiple surgeries (e.g., congenital viral infection, hydrops, complex congenital heart disease, severe dysmorphic features, etc.)\n3. Severe metabolic alkalosis, in critically ill neonates, is defined as a persistent elevation of the serum pH above 7.45 and it also involves a primary increase in serum bicarbonate (HCO3-) concentration \\> 25mEq\u002FL.\n4. Severe Hypernatremia, in critically ill neonates, is defined as persistently high serum sodium levels \\> 150 mmol\u002FL\n5. Severe liver failure and syndromic infants with multiple congenital abnormalities and severe perinatal asphyxia\n\n   \\-","1 Day","3 Days",{"count":144,"type":21},200,[146],"PHASE3","The goal of this clinical trial is to learn if the addition of sodium acetate in neonatal PN works to prevent and treat metabolic acidosis and associated comorbidities in preterm neonates. It will also teach about the optimal doses of sodium acetate in PN. The main questions it aims to answer are:\n\nIs the incidence of metabolic acidosis reduced in preterm neonates who received daily Sodium acetate in PN therapy (treatment) during the initial weeks of life compared with individuals who received sodium chloride in PN (standard)? Is the rate of neonatal comorbidities reduced in preterm neonates who received daily Sodium acetate in PN therapy (treatment) during the initial weeks of life compared with individuals who received sodium chloride in PN (standard)? What are the optimal neonatal dosing recommendations\u002Fguidelines of sodium acetate in daily PN, which are required to prevent\u002Ftreat metabolic acidosis in the early life of preterm neonates? Researchers will compare Sodium acetate in PN therapy to sodium chloride in PN to see if Sodium acetate works to prevent and treat metabolic acidosis and associated comorbidities.\n\nIncluded Participants:\n\nAll the neonates were admitted to the NICU of AKUH and received PN during 28 days of their lives.\n\nParticipants will receive sodium acetate or sodium chloride Written informed consent was obtained by parents\u002Flegal representatives (according to local regulations) before the initiation of PN. Gestational age \\\u003C 33 weeks Included in the study before 72 hours of life",[149,150,151],"Metabolic Acidosis","Neonatal Disease","Neonatal Complication",[153,154,155,156],"metabolic acidosis","sodium acetate","neonates","Parenteral Nutrition","2024-08-07",{"date":159,"type":37},"2024-08-09",{"date":161,"type":37},"2024-07-10",{"date":163,"type":21},"2025-05-10",{"name":43,"class":44},""]