Perspectives in Clinical Research最新文献

{"title":"Changing landscape of geriatric clinical trials: Analysis of Clinical Trials Registry of India.","authors":"Abissha Sargunaraj, Jerin James, P Kala, R Jamuna Rani","doi":"10.4103/picr.picr_59_24","DOIUrl":"10.4103/picr.picr_59_24","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"15 4","pages":"215-216"},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11584156/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142710893","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Statistical tools and packages for data collection, management, and analysis - A brief guide for health and biomedical researchers.","authors":"Vishal Deo, Priya Ranganathan","doi":"10.4103/picr.picr_160_24","DOIUrl":"10.4103/picr.picr_160_24","url":null,"abstract":"<p><p>Previous articles in this series have looked at various aspects of planning, designing, conducting and interpreting biomedical research. In this article, we offer an overview of some tools and resources available to health and biomedical researchers, to help them with their research.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"15 4","pages":"209-212"},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11584161/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142710896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative efficacy and safety of gabapentin, pregabalin, oxcarbazepine, and duloxetine in diabetic peripheral neuropathy: A network meta-analysis.","authors":"Karan Bhavesh Shah, Devang A Rana, Yash Dharmendra Mehta, Supriya Deepak Malhotra","doi":"10.4103/picr.picr_218_23","DOIUrl":"10.4103/picr.picr_218_23","url":null,"abstract":"<p><strong>Purpose: </strong>To conduct a network meta-analysis comparing the safety and efficacy of gabapentin (GBP), pregabalin (PGB), oxcarbazepine (OXC), and duloxetine (DLX) in treating diabetic peripheral neuropathy (DPN).</p><p><strong>Materials and methods: </strong>The study's eligibility criteria includee randomized controlled trials (RCTs) with a focus on DPN patients receiving GBP, PGB, DLX, or OXC versus placebo. Noncompliant trials with incomplete information and observational studies were excluded.</p><p><strong>Results: </strong>Twelve (RCTs) of PGB, 2 of GBP, 3 of DLX, and 1 of OXC met the inclusion criteria. When drugs were compared for efficacy (direct comparison), GBP (Odd's ratio [OR] = 3.208, <i>P</i> < 0.001) was most effective followed by OXC (OR = 2.4, <i>P</i> = 0.0248), DLX (OR = 2.346, <i>P</i> < 0.001), and PGB (OR = 2.161, <i>P</i> < 0.001). When drugs were compared for withdrawal due to adverse <i>drug</i> reaction (ADR) (direct comparison), GBP (OR = 1.3818, <i>P</i> = 0.766) was safest followed by PGB (OR = 2.16, <i>P</i> < 0.001), DLX (OR = 2.469, <i>P</i> < 0.001), and OXC (OR = 4.4967, <i>P</i> = 0.001). Indirect comparison was done for efficacy, DLX was statistically significant than PGB and OXC (DLX vs. PGB, <i>P</i> = 0.03; DLX vs. OXC, <i>P</i> = 0.02). When indirect comparison was done for patient withdrawal due to ADR, OXC was worst (GBP vs. OXC, <i>P</i> = 0.0001; PGB vs. OXC, <i>P</i> = 0.007; DLX vs. OXC, <i>P</i> = 0.015). When drugs were compared for individual ADRs (direct comparison), dizziness was most commonly seen with OXC (OR = 9.6535, <i>P</i> = 1.8425), headache with OXC (OR = 3.8686, <i>P</i> = 0.006), somnolence with PGB (OR = 5.189, <i>P</i> < 0.001), and nausea with DLX (OR = 3.264, <i>P</i> < 0.001). GBP was most effective and safest drug followed by OXC > DLX > PGB for efficacy and PGB > DLX > OXC for safety.</p><p><strong>Conclusion: </strong>In evaluating medications for DPN against placebo, GBP and OXC demonstrated the highest effectiveness while maintaining a favorable safety profile.</p>","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"15 4","pages":"202-208"},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11584157/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142710895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of student-led “Association for Support and Propagation of Innovation, Research, and Education” (A.S.P.I.R.E) in empowering undergraduate medical students in research: A 2-year longitudinal study","authors":"Shirish Rao, Yashika Yagade, Amey Ambike, Aarya Desai, Amey Kundawar, Alhad Mulkalwar, Munira Hirkani, Raakhi Tripathi","doi":"10.4103/picr.picr_25_24","DOIUrl":"https://doi.org/10.4103/picr.picr_25_24","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":" 669","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141823787","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of quick penetrating solution heparin, quick penetrating solution diclofenac, and heparin gel in the prevention of infusion-associated superficial thrombophlebitis: A randomized controlled trial","authors":"Vijeta Bajpai, Tejas K. Patel, Priyanka Dwivedi, Ankita Kabi, Yashpal Singh, Richa Agarwal, Ravi Gupta, Surekha Kishore","doi":"10.4103/picr.picr_305_23","DOIUrl":"https://doi.org/10.4103/picr.picr_305_23","url":null,"abstract":"\u0000 \u0000 \u0000 The present study aimed to compare the efficacy, safety, and cost-effectiveness of quick penetrating solution (QPS) heparin, QPS diclofenac, and heparin gel in the prevention of superficial thrombophlebitis (ST).\u0000 \u0000 \u0000 \u0000 This randomized controlled trial was conducted after approval from the Institutional Ethics Committee and registration to Clinical Trial Registry of India. Patients of 18–60 years age, American Society of Anesthesiologists I/II, and who needed venous cannulation for at least 72 h were included in the study. Patients were randomly divided into three groups receiving study drugs (heparin gel, QPS heparin, and QPS diclofenac) every 8 hourly for a period of 72 h. Venous cannulation site was graded using the Visual Infusion Phlebitis Scale. Patients developing no ST, mean time to reach ST Grade 1 and 2, prevention of ST probability, and cost-effectiveness of interventions during the study period were assessed.\u0000 \u0000 \u0000 \u0000 Out of 219 included patients, development of no ST in the study groups at 72 h of treatment were heparin gel (11%), QPS heparin (9.6%), and QPS diclofenac (2.7%). The mean time (hours) to develop any grade ST in the study arms was heparin gel (36.2 [11.9]), QPS heparin (40.0 [13.4]), and QPS diclofenac (37.0 [13.2]). The Kaplan–Meier analysis did not reveal significant differences for the prevention of any grade ST or severe ST in three treatment arms. The average cost-effectiveness ratio for preventing thrombophlebitis was 14.2 in heparin gel-, 13.2 in QPS heparin-, and 95.6 in QPS diclofenac-treated patients.\u0000 \u0000 \u0000 \u0000 Based on efficacy, safety, and cost-effectiveness, heparin gel or QPS heparin can be used to prevent ST due to intravenous cannulation in surgical patients. QPS diclofenac is not a cost-effective option to prevent ST.\u0000","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"14 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141661090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pleiotropic effect of teneligliptin versus glimepiride add-on therapy on hs-CRP and cardiorenal parameters in Indian type 2 diabetes patients: An open-labeled randomized controlled trial","authors":"M. Kanimozhi, Manisha Bisht, Ravikant, Arkapal Bandyopadhyay, Manisha Naithani, S. Handu","doi":"10.4103/picr.picr_265_23","DOIUrl":"https://doi.org/10.4103/picr.picr_265_23","url":null,"abstract":"\u0000 \u0000 \u0000 The objective of the study was to estimate the pleiotropic effect of teneligliptin on high-sensitivity C-reactive protein (hs-CRP) levels and some cardiorenal parameters in comparison to glimepiride, both as add-on therapy to metformin.\u0000 \u0000 \u0000 \u0000 This 12-week open-label, parallel-group, randomized controlled trial was conducted among Indian people with type 2 diabetes mellitus and on metformin monotherapy with poor glycemic control (glycated hemoglobin >7% or 53 mmol/mol). The endpoints were mean change in hs-CRP levels, systolic blood pressure (SBP), diastolic blood pressure (DBP), serum creatinine, blood urea, estimated glomerular filtration rate (eGFR), and change in cardiovascular (CV) risk categories from baseline to end of 12 weeks.\u0000 \u0000 \u0000 \u0000 Seventy participants were randomized (1:1) to receive either teneligliptin 20 mg once daily (n = 35) or glimepiride 1 mg twice daily (BD) (n = 35) as an add-on to metformin 500 mg BD. The mean age of the participants was 50.65 and 50.7 years in arms 1 and 2, respectively. At 12-weeks end, teneligliptin add-on caused a statistically significant reduction in hs-CRP compared to glimepiride in both per-protocol (PP) and intention-to-treat (ITT) sets. No significant difference was observed for changes in SBP and DBP, creatinine, urea, eGFR levels, and CV risk category in both PP and ITT sets.\u0000 \u0000 \u0000 \u0000 Teneligliptin add-on resulted in favorable effects on hs-CRP levels and comparable effects on cardiorenal parameters compared to glimepiride add-on therapy at 12-weeks end.\u0000 This trial has been prospectively registered in CTRI (Clinical Trials Registry of India). Registration number: CTRI/2021/08/035342.\u0000","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"44 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141660230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Experience of participating in community-based clinical trials from rural Maharashtra: Analysis of over 4000 participant feedback forms","authors":"Arunkumar Gondhali, Rakesh Patil, Manoj Dagwar, Ravikant Vishwakarma, H. Lubree, G. Dayma, A. Kawade, Aditi Apte","doi":"10.4103/picr.picr_289_23","DOIUrl":"https://doi.org/10.4103/picr.picr_289_23","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"1 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141695311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical trial footprint in BRICS: Improvements seen but needs further affirmative action","authors":"Sanish Davis","doi":"10.4103/picr.picr_109_24","DOIUrl":"https://doi.org/10.4103/picr.picr_109_24","url":null,"abstract":"","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"28 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141704687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bio-entrepreneurs’ bugbear: Regulatory rigmarole","authors":"Arun Bhatt","doi":"10.4103/picr.picr_103_24","DOIUrl":"https://doi.org/10.4103/picr.picr_103_24","url":null,"abstract":"\u0000 Indian biotech startup sector – a rapidly growing business segment focused on the development of innovative products has the potential to make significant contributions to the country’s economy. Indian bio-entrepreneurs’ optimistic expectation of rapidly moving product development from bench to bedside faces tremendous challenges of the complex Indian regulatory system, which is shaped by a diversity of regulatory authorities, rules, guidelines, and processes. This brief review discusses specific regulatory issues faced by bio-entrepreneurs investing in a variety of innovative products – new drugs, vaccines, medical devices, cell, and gene therapy and suggests approaches which can ease Indian entrepreneur’s endeavors.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"222 11","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141692473","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sample size calculation in clinical research","authors":"P. Ranganathan, Vishal Deo, C. Pramesh","doi":"10.4103/picr.picr_100_24","DOIUrl":"https://doi.org/10.4103/picr.picr_100_24","url":null,"abstract":"\u0000 Calculation of sample size is an essential part of research study design since it affects the reliability and feasibility of the research study. In this article, we look at the principles of sample size calculation for different types of research studies.","PeriodicalId":20015,"journal":{"name":"Perspectives in Clinical Research","volume":"40 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141698090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}