Clinical trials

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. Our 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. Hypothesis: Mobile health technology positively improves clinical and functional outcomes of proximal humerus fracture using validated outcome scoring scales. Objectives: Primary objective: 1. 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. 2. To compare patient clinical and functional outcomes by validated scoring scales between using mobile health app versus standard care. Secondary Objective: To increase patient and doctor satisfaction rate in perspective with treatment provision usefully by digital technology application. Methods: Study design: Patient-centered, open labelled, parallel (1:1), pilot randomized controlled trial. Total 60 subjects required with 30 in each arm in 24-month duration. Study procedures: 1. Proximal humerus rehabilitation exercises video will be prepared after obtaining written informed consent from designated orthopaedic residents/surgeon. 2. 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. 3. Written informed consent will be administered the study subjects as per GCP guideline. 4. Each eligible patient will be randomized into intervention or control group. 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. 2. Control group: Routine care will be provided to control group and as per routine. 5. 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. 6. 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. 7. Patient satisfaction questionnaire: Administered to intervention group only about impact of digital technology application on their health improvement and care outcomes. 8. Doctor satisfaction questionnaire: To assess treating surgeon satisfaction rate for digital technology application impact on intervention group patients' care and outcomes. 9. The research study does not seem to have any potential health hazard. As per Food and Drug Administration and GCP recommendations for Serious/Adverse event (SAE/AE), any patient who experience SAE/AE, will receive good clinical care at earliest and all relevant reporting bodies will be notified. 10. 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. Statistical Consideration: Quantitative 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/SAEs 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%. Patient 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.

Femur and tibia shaft fractures are common after trauma with a burden of 5% and 20% respectively. Clinicians recommend costly bone strengthening drugs/supplements 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. Hypothesis: 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. Primary Objectives: 1. 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. 2. To compare the incidence of adverse events between almonds and vitamin D3 treatments up to 13 weeks follow-up. Secondary Objectives: 1. To compare the almonds and vitamin D3 treatment cost. 2. To compare within group blood vitamin D levels (ng/mL) at baseline and post-treatment follow-ups. Methods: Study design: Single-center, open-labeled, crossover, non-inferiority randomized controlled trial. Total 136 subjects are required with 14 subjects in group 1 and 122 in group 2.in 24-month duration. Study procedures: 1. Regulatory and Ethical approvals. 2. 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/toxicity to almonds and/or vitamin D supplements. 3. Written informed consent administration. 4. Randomization Patients (N=136) are divided into two groups. Group 1 (N=14, vitamin D insufficiency, blood vitamin D level 21-29 ng/mL) and Group 2 (N=122, vitamin D deficiency, blood vitamin D level ≤20 ng/mL). I. Group 1 (N=14): Arm A (n=7)=5 grams/day of almonds for 4 weeks, followed by 7 days washout period and cross-over treatment by oral vitamin D3 200,000 units/week for 8 weeks. Arm B (n=7)=Oral vitamin D3 200,000 units/week for 8 weeks, followed by 7 days washout period and cross-over treatment by 5 grams/day of almonds for 4 weeks II. Group 2 (N=122): Arm B (n=61)=Oral vitamin D3 200,000 units/week for 8 weeks, followed by 7 days washout period and cross-over treatment by 5 grams/day of almonds for 4 weeks. Arm C (n=61)=Oral vitamin D3 200,000 units/week together with 5 grams/day almonds for 4 weeks, followed by 7 days washout period and cross-over treatment by oral vitamin D3 200,000 units/week for 8 weeks. 5. Patients are followed at 4 weeks and 13 weeks follow-ups after treatment. 6. Fracture site routine X-rays and RUST scores are assessed by treating surgeon/investigator(s) at follow-ups for bone fracture healing. 7. Investigational product (IP) safety assessment and reporting as per ICH-GCP guidelines. Subjects experiencing any adverse event (AE)/serious adverse event (SAE) is provided optimum care at earliest. All relevant reporting bodies are notified within recommended timeline. 8. 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. 9. Patients can withdraw from the study at any time without losing any of his/her patient rights. 10. Study close-out process will be of one to two-month duration. Statistical analysis: The SPSS version 19.0 will be used to analyze data. Quantitative variables will be expressed as mean±SD/median (IQR) and qualitative as frequencies (%). IP related AEs/SAEs will be assessed by incidence/stratification. 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/Mann Whitney U test. The p-value \<0.05 is considered significant. Multiple regression analysis for association of covariates and outcome will be used.

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. OBJECTIVES: The objectives of this study are: * 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. * 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

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. Objective: This randomized control trial aimed to compare the effects of structured versus verbal education on anxiety and satisfaction in patients undergoing uroflowmetry. Methodology: 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.

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: Is 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/guidelines of sodium acetate in daily PN, which are required to prevent/treat 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. Included Participants: All the neonates were admitted to the NICU of AKUH and received PN during 28 days of their lives. Participants will receive sodium acetate or sodium chloride Written informed consent was obtained by parents/legal representatives (according to local regulations) before the initiation of PN. Gestational age \< 33 weeks Included in the study before 72 hours of life