International Journal of Clinical Trials最新文献

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Tele-assessment of Berg balance scale, timed-up, go and box and block test in patients with chronic stroke: establishing agreement with the face-to-face assessment 远程评估慢性中风患者的伯格平衡量表、定时起立、围棋和方块测试:确定与面对面评估的一致性
International Journal of Clinical Trials Pub Date : 2024-04-24 DOI: 10.18203/2349-3259.ijct20240960
Efthalia Panagiotopoulou, A. Mavronasou, Savvas Spanos, Eleni A. Kortianou
{"title":"Tele-assessment of Berg balance scale, timed-up, go and box and block test in patients with chronic stroke: establishing agreement with the face-to-face assessment","authors":"Efthalia Panagiotopoulou, A. Mavronasou, Savvas Spanos, Eleni A. Kortianou","doi":"10.18203/2349-3259.ijct20240960","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240960","url":null,"abstract":"Background: The COVID-19 pandemic has triggered rapid adaptive actions in favor of remote interventions and clinical assessment methods. The reliability of functional tests used in remote assessment is limited in patients with chronic stroke. The aim of the study was to assess the inter-reliability of the Berg balance scale, the timed-up and go test, and the box and block test via remote assessment, in patients with chronic stroke.\u0000Methods: Fifteen patients (8 men and 7 women) underwent a home-based teleassessment using a software platform and a center-based face-to-face assessment, on two consecutive days. The assessment order was randomized and conducted by an independent examiner. All participants were instructed regarding the use of the software platform, home equipment preparation, and safety issues\u0000Results: Participants aged 50-70 years (mean 59.6±7.34) with an average of 4.8±2.5 years after stroke and a moderate degree of motor dependence (Barthel scale: mean 83±8.61 units) completed all tests in both assessment procedures without experiencing adverse events. The inter-reliability was moderate for the total BBS score: ICC=0.869 (95% CI: 0.616 to 0.955), excellent for the total time of the TUG: ICC=0.968 (95% CI: 0.907 to 0.989) as well as for the upper right and left arm scores of the BBT: ICC=0.974 (95% CI: 0.922 to 0.991) and ICC=0.966 (95% CI: 0.897 to 0.988), respectively.\u0000Conclusions: Tele-assessment for BBS, TUG, and BBT appears moderate to excellent inter-reliability in functionally independent patients with chronic stroke.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"41 6","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140662934","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}
引用次数: 0
Diagnostic accuracy of pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized: a prospective diagnostic cohort study 前瞻性队列诊断研究:袖珍肺部超声波在确定住院儿童肺炎病因和监测并发症方面的诊断准确性
International Journal of Clinical Trials Pub Date : 2024-04-24 DOI: 10.18203/2349-3259.ijct20240965
Sara Monteiro, Teresa Tavares, Luís Salazar, Filipa Coelho, João Carvalho, Telma Barbosa, Maria G. Reis, Lurdes Morais, Ana Ramos, Manuel Ferreira-Magalhães
{"title":"Diagnostic accuracy of pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized: a prospective diagnostic cohort study","authors":"Sara Monteiro, Teresa Tavares, Luís Salazar, Filipa Coelho, João Carvalho, Telma Barbosa, Maria G. Reis, Lurdes Morais, Ana Ramos, Manuel Ferreira-Magalhães","doi":"10.18203/2349-3259.ijct20240965","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240965","url":null,"abstract":"Background: Pneumonia, the leading infectious cause of death in children worldwide, often requires a chest radiograph (CXR) for diagnosis, involving radiation exposure. Point-of-Care Ultrasound (POCUS) offers a radiation-free alternative and, specifically the pocket-size variant, enhances convenience at the patient's bedside. While evidence supports ultrasound's accuracy in detecting community-acquired pneumonia (CAP) in children comparable to CXR, few studies have explored its ability to distinguish pneumonia etiology, especially utilizing pocket-size POCUS devices.\u0000Methods: In this prospective diagnostic cohort study conducted over a year in a tertiary pediatric referral center, we aim to assess the diagnostic accuracy of a pocket-size POCUS device compared to CXR for determining the etiology of CAP in pediatric patients (aged >6 months and <18 years). At least 76 participants diagnosed with CAP will undergo independent POCUS examinations at various intervals, complemented by CXRs when necessary, independently classified by a third investigator. The General Electrics Vscan AirTM®, featuring Bluetooth connectivity to smartphone/tablet, will be employed for POCUS. Data collection will include systematized POCUS and CXR descriptions, alongside sociodemographic, clinical, and therapeutic variables. Statistical analysis using SPSS® version 28 will evaluate the diagnostic accuracy of the POCUS device.\u0000Conclusions: This trial's outcomes hold significant promise in unveiling unknown data about the diagnostic accuracy of pocket-size POCUS for pediatric CAP etiological diagnosis. Utilizing a device meeting technical recommendations, featuring a dual-headed probe and Bluetooth connectivity, this study has the potential to bring innovation to clinical practice, improving patient care and creating scientific value.\u0000Trial Registration Number: NCT06296693.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"18 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140664994","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}
引用次数: 0
Is it fear or politics? A qualitative exploration of stakeholders’ views on the failed Ebola vaccine trial in Southern Ghana 是恐惧还是政治?利益相关者对加纳南部埃博拉疫苗试验失败的定性分析
International Journal of Clinical Trials Pub Date : 2024-04-24 DOI: 10.18203/2349-3259.ijct20240962
S. Chatio, J. Ganle, Ulrike Beisel, James Akazili, Patrick Ansah, P. Adongo
{"title":"Is it fear or politics? A qualitative exploration of stakeholders’ views on the failed Ebola vaccine trial in Southern Ghana","authors":"S. Chatio, J. Ganle, Ulrike Beisel, James Akazili, Patrick Ansah, P. Adongo","doi":"10.18203/2349-3259.ijct20240962","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240962","url":null,"abstract":"Background: The negative meaning and rumours associated with the conduct of clinical trials regarding their experimental nature adversely affect trust and their conduct. A typical example of the challenges in conducting clinical trial studies was where Ghana was selected to conduct the ebola vaccine trials, which was not successful. This study explored the social and political perspectives on the unsuccessful implementation of the ebola vaccine trial in Ghana.\u0000Methods: This was a cross-sectional exploratory study using qualitative research approach where 31 in-depth individual interviews and Key informant interviews were conducted with participants. The interviews were recorded, transcribed and coded into themes using Nvivo 12 software to aid thematic content analysis.\u0000Results: The views expressed by participants suggested that lack of stakeholder engagement to create awareness on the Ebola vaccine trial led to doubts on the purpose for the trial. Also, media propaganda, negative influence and the perception that conducting the vaccine trial in Ghana could introduce the Ebola virus into the country created panic and fear, which affected public trust and support for the Ebola vaccine trial conduct in Ghana. Furthermore, political influence linked with site selection and timing for the study in particular, led to mistrust and the subsequent suspension of the trial in Ghana.\u0000Conclusions: Based on the interpretation of our data, we conclude that the indefinite suspension of the Ebola vaccine trial in Ghana could largely be attributed to both fear and political influence as well as misinformation resulting from media propaganda leading to mistrust.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"19 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140660455","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}
引用次数: 0
Comparison of the effects of two concentrations of adrenaline (0.33 mg/l versus 1 mg/l) in the irrigation serum for arthroscopic shoulder surgery: protocol of a randomized controlled trial 肩关节镜手术灌洗血清中两种浓度肾上腺素(0.33 毫克/升和 1 毫克/升)的效果比较:随机对照试验方案
International Journal of Clinical Trials Pub Date : 2024-04-24 DOI: 10.18203/2349-3259.ijct20240966
Edouard Harly, Anselme Billaud, H. Demezon, Thierry Joudet, Clément Tournier, Antony Pincin
{"title":"Comparison of the effects of two concentrations of adrenaline (0.33 mg/l versus 1 mg/l) in the irrigation serum for arthroscopic shoulder surgery: protocol of a randomized controlled trial","authors":"Edouard Harly, Anselme Billaud, H. Demezon, Thierry Joudet, Clément Tournier, Antony Pincin","doi":"10.18203/2349-3259.ijct20240966","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240966","url":null,"abstract":"Background: Controlling bleeding during arthroscopic shoulder surgery helps improve the clarity of the arthroscopic visual field. Adrenaline is considered an effective and safe method to reduce bleeding. Two doses of adrenaline (0.33 mg/l and 1 mg/l) have been evaluated in the literature, but never against each other.\u0000Methods: This prospective, double-blind, randomized controlled trial will study the clarity of the visual field using a numerical scale (NS) during rotator cuff surgery on 180 patients across 5 centres. The secondary objectives include: the duration of the operation, volume of saline used, increase in baseline pressure, number of arthropump hyperpressures, mean systolic blood pressure and heart rate, as well as sudden variability.\u0000Results: Among the 154 patients in the Clinical Trial Group, 70/154 (45%) continued to have proteinuria, while 84/154 (55%) had no proteinuria (remission) compared to 41 (28%) in remission and 104 (72%) with continued proteinuria in the Usual Care group (p<0.001).\u0000Conclusions: This study aims to determine which of the two dosages previously studied in the literature (0.33 mg/l versus 1 mg/l) provides better clarity.\u0000Trial Registration Number: 2021-A02773-38. ","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"55 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140665057","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}
引用次数: 0
Cheese positively affects serum osteocalcin levels, bone turnover markers and bone mineral density in cross-country skiers: a dose-response study 奶酪对越野滑雪者的血清骨钙素水平、骨转换标志物和骨矿物质密度有积极影响:一项剂量反应研究
International Journal of Clinical Trials Pub Date : 2024-04-24 DOI: 10.18203/2349-3259.ijct20240961
H. E. Lundberg, J. Sundgot-Borgen, Therese Fostervold Mathisen, Helge Holo, A. C. Whist, Stig Larsen
{"title":"Cheese positively affects serum osteocalcin levels, bone turnover markers and bone mineral density in cross-country skiers: a dose-response study","authors":"H. E. Lundberg, J. Sundgot-Borgen, Therese Fostervold Mathisen, Helge Holo, A. C. Whist, Stig Larsen","doi":"10.18203/2349-3259.ijct20240961","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240961","url":null,"abstract":"Background: Vitamin K2-rich Jarlsberg Cheese is demonstrated to increase Osteocalcin and bone turnover markers in fertile women. The impact on endurance-trained young cross-country skiers (XCS) with elevated bone turnover remains unclear. Purpose of study was to estimate the optimal daily efficacy dose of Jarlsberg cheese to increase serum Osteocalcin level in young female and male XCS and estimate the Jarlsberg effect on bone turnover markers (BTMs) and bone mineral density (BMD).\u0000Methods: In a parallel group study consisting of three design levels, 10 female and 10 male XCS were included, using Response Surface Pathway design. Blood samples were taken at each level for measurements of Osteocalcin, vitamin K2, BTMs and other biochemical parameters. Resting metabolic rate (RMR), BMD, VO2max and muscle strength were measured at start and at the end of the study.\u0000Results: The Osteocalcin development with increasing dose of Jarlsberg cheese was almost parallel in both sexes. These variables were reduced significantly from baseline during the first two design levels but increased above baseline by the end of the study. BTMs decreased significantly during the first and second level but increased during the third level. Total and L1-L4 BMD, s-phosphate, s-urea, RMR, muscle strength and Peak VO2 increased significantly while s-calcium and s-magnesium decreased.\u0000Conclusions: Estimated OED of Jarlsberg cheese was 73 and 84 g/day for females and male athletes, respectively. The development in OC, BTMs and BMD suggest an antiresorptive and perhaps anabolic effect of Jarlsberg Cheese on bone tissue. VO2 max, RMR and muscular strength development indicated an anabolic situation.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"65 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140665267","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}
引用次数: 0
Exploring the cessation efficacy and harm reduction potential of heated tobacco and nicotine pouch products in smokers and smokeless tobacco users: study protocol of a 6-month randomized controlled switching trial 探索加热烟草和尼古丁袋产品对吸烟者和无烟烟草使用者的戒烟疗效和减害潜力:为期 6 个月的随机对照转换试验的研究方案
International Journal of Clinical Trials Pub Date : 2024-04-24 DOI: 10.18203/2349-3259.ijct20240964
Nikola Pluym, Therese Burkhardt, Max Scherer
{"title":"Exploring the cessation efficacy and harm reduction potential of heated tobacco and nicotine pouch products in smokers and smokeless tobacco users: study protocol of a 6-month randomized controlled switching trial","authors":"Nikola Pluym, Therese Burkhardt, Max Scherer","doi":"10.18203/2349-3259.ijct20240964","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240964","url":null,"abstract":"Background: Despite decades of research on pharmacological and behavioural smoking cessation treatments, current quit aids are of limited success. The introduction of new, combustion-free nicotine and tobacco products extended the tool kit for people who smoke to switch away from their risky habit. We performed a systematic review including 120 studies resulting in several recommendations for a robust study design to determine the cessation efficacy of a new nicotine or tobacco product. Consequently, we prepared this study protocol to assess the cessation efficacy of heated tobacco products (HTPs) and nicotine pouches (NPs).\u0000Methods: 250 subjects (125 exclusive smokers and 125 exclusive smokeless tobacco (SLT) users) will be recruited and offered a choice of HTPs in case of smokers and a choice of NPs in case of SLT users in order to switch. Subjects will undergo four visits (baseline, 1, 3, and 6 months) to collect biospecimens and for physical examinations. Use behaviour and questionnaires will be monitored on a regular basis by means of a smartphone-app. We describe a sensitive and specific compliance monitoring using suitable biomarkers of exposure. The sample size of 250 subjects and duration of 6 months will allow the quit rates to be assessed with sufficient statistical power. Finally, the choice between different products shall reflect the individuals’ preferences.\u0000Conclusions: This protocol can be applied generically, providing a robust determination of a products’ cessation efficacy.\u0000Trial Registration: The trial will be registered in the International Clinical Trials Registry Platform.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"2 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140661538","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}
引用次数: 0
Effectiveness of catheter-associated urinary tract infections bundle approach to reduce urinary catheter associated infection rate among children admitted in Paediatric unit 导尿管相关尿路感染捆绑方法对降低儿科病房儿童导尿管相关感染率的效果
International Journal of Clinical Trials Pub Date : 2024-04-24 DOI: 10.18203/2349-3259.ijct20240963
Anju Shukla, Subin S., Anugrah Charan, Neeraj Aanand
{"title":"Effectiveness of catheter-associated urinary tract infections bundle approach to reduce urinary catheter associated infection rate among children admitted in Paediatric unit","authors":"Anju Shukla, Subin S., Anugrah Charan, Neeraj Aanand","doi":"10.18203/2349-3259.ijct20240963","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240963","url":null,"abstract":"Background: CAUTI bundle care aims to reduce catheter associated urinary tract infection, enhance quality of life and promote comfort. The present study aimed to assess the effect of CAUTI bundle approach on urinary catheter associated infection rate among children admitted in paediatric unit of KGMU.\u0000Methods: Quantitative research approach was done on 46 children who were admitted in paediatric unit, KGMU, Lucknow. Purposive sampling technique was used. Socio demographic was obtained by socio demographic Performa, CAUTI was assessed by urine culture test and symptomatic assessment of UTI.\u0000Results: The result revealed that on the basis of urine culture results, in exposed group majority of the children that is 18 (78.26%) was sterile and rest 5 (21.73%) was infected and in unexposed group 13 (56.52%) children was sterile and remain 10 (43.47%) was infected. And on the basis of symptomatic assessment for CAUTI, in exposed group majority of the children that is 17 (73.91%) are less symptomatic and remain 6 (26.08%) was more symptomatic for CAUTI and in unexposed group most of the children that is 14 (60.86%) was less symptomatic for CAUTI and rest 9 (39.13%) was more symptomatic for CAUTI.\u0000Conclusions: CAUTI bundles approach provides evidence-based prevention practices and strategies to reduce CAUTI. The present study found that CAUTI bundle care was effective in reducing CAUTI in children.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"3 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140661870","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}
引用次数: 0
A prospective, randomized double-blind, placebo-controlled study for safety and efficacy of SesZen-BioTM: a proprietary Sesbania grandiflora extract in managing hair and scalp health in healthy adults 一项前瞻性、随机双盲、安慰剂对照研究,以了解 SesZen-BioTM(一种专有的大叶芝麻提取物)对健康成年人头发和头皮健康管理的安全性和有效性
International Journal of Clinical Trials Pub Date : 2024-04-06 DOI: 10.18203/2349-3259.ijct20240929
Ratna Upadhyay, Mihir C. Gadani, Sneha Badak, Nayan Patel, Apeksha Merja, Maheshvari Patel
{"title":"A prospective, randomized double-blind, placebo-controlled study for safety and efficacy of SesZen-BioTM: a proprietary Sesbania grandiflora extract in managing hair and scalp health in healthy adults","authors":"Ratna Upadhyay, Mihir C. Gadani, Sneha Badak, Nayan Patel, Apeksha Merja, Maheshvari Patel","doi":"10.18203/2349-3259.ijct20240929","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240929","url":null,"abstract":"Background: Hair loss, a common multifactorial condition affecting both genders, results from causes like extrinsic factors (pollution, sun, humidity, and temperature), nutritional variation, or intrinsic factors such as ageing, heredity, hormonal and medical conditions. Some of the damages caused by these factors can be effectively managed with multivitamins, minerals, antioxidant natural products. Present study assessed use of standardised herbal Sesbania grandiflora extract for improving hair density, hair thickness and scalp health along with a serum biomarker to establish the probable mechanism of action.\u0000Methods: The study was approved by the ethics committee and was conducted as per standard national regulations. 51 randomized subjects (mean age: 39.40±5.80 years) received either test-treatment or placebo for consecutive 56 days. Instrumental assessments included a phototrichogram to assess hair density, thickness, and scalp condition.\u0000Results: SesZen-BioTM which is derived from Sesbania grandiflora extracts showed an improvement in hair density, hair thickness and ferritin in 8 weeks of usage suggesting it stimulates the keratin production which resulted in improved follicle growth. By day 56 of usage, hair density and thickness improved by 58.92±28.69 cm2 and 3.68±2.69 μm respectively from baseline (both p<0.0001) in the treatment group. This indicates towards 25% improvement in hair density, 16.94% in hair thickness and almost 72% volunteers indicated an improvement in hair health along with 27% increase in serum ferritin.\u0000Conclusions: Sesbania grandiflora extract -SesZen-Bio® showed beneficial nutritional effects on research subjects, proving its usefulness as a well-tolerated and efficient daily supplement to improve hair health.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"12 11","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140734913","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}
引用次数: 0
Effects of home-based remote rehabilitation on children and adolescents with cystic fibrosis and non-cystic fibrosis bronchiectasis: a systematic review protocol 家庭远程康复对患有囊性纤维化和非囊性纤维化支气管扩张症的儿童和青少年的影响:系统性审查方案
International Journal of Clinical Trials Pub Date : 2024-03-01 DOI: 10.18203/2349-3259.ijct20240655
A. Mavronasou, Vaia Sapouna, A. Spinou, Konstantinos Douros, Eleni A. Kortianou
{"title":"Effects of home-based remote rehabilitation on children and adolescents with cystic fibrosis and non-cystic fibrosis bronchiectasis: a systematic review protocol","authors":"A. Mavronasou, Vaia Sapouna, A. Spinou, Konstantinos Douros, Eleni A. Kortianou","doi":"10.18203/2349-3259.ijct20240655","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240655","url":null,"abstract":"Background: Home-based remote rehabilitation combining the use of new technological tools is an alternative way of rehabilitation when traditional center-based programs are limited or are not feasible. This systematic review aims to investigate the level of evidence for the effects of home-based remote rehabilitation on children and adolescents with cystic fibrosis (CF) and non-cystic fibrosis bronchiectasis (NCFB).\u0000Methods: This systematic review will follow the preferred reporting items for systematic reviews and meta-analysis (PRISMA). Five databases will be searched from the period of the inception until March 2024: PubMed, Web of Science, Medline (via EBSCOhost), ACM Digital Library, and Scopus. Methodological quality will be assessed using the revised Cochrane Risk of Bias tool for randomized trials (RoB 2) and the risk of bias in non-randomized studies – of interventions (ROBINS-1) tool. The overall quality of the evidence will be assessed using the grading of recommendations assessment, development, and evaluation (GRADE) approach.\u0000Conclusions: Evaluation of the level of evidence for the effects of home-based remote rehabilitation in children and adolescents with CF and NCFB is an important step in the context of telehealth, providing an alternative way of approaching pediatric patients, during the process of rehabilitation.\u0000Trial registration: PROSPERO registration number is CRD42024498403.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"19 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140084902","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}
引用次数: 0
Screening of herbal extracts for rapid effect on activity-induced knee joint discomfort: a randomized, placebo-controlled pilot study 筛选草药提取物对活动引起的膝关节不适的快速疗效:随机安慰剂对照试验研究
International Journal of Clinical Trials Pub Date : 2024-02-23 DOI: 10.18203/2349-3259.ijct20240400
Shalini Srivastava, R. Girandola
{"title":"Screening of herbal extracts for rapid effect on activity-induced knee joint discomfort: a randomized, placebo-controlled pilot study","authors":"Shalini Srivastava, R. Girandola","doi":"10.18203/2349-3259.ijct20240400","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20240400","url":null,"abstract":"Background: A feasibility study was conducted to investigate the effect of different proprietary extracts on joint discomfort associated with repeated episodes of physical activity.\u0000Methods: A single-dose randomized, double-blind, placebo-controlled cross-over study was conducted in three phases with different extract combinations. Seventeen individuals aged 40-60 years with a history of knee joint pain aggravation on physical stress were randomized to receive the investigational product or the placebo in a 1:1 ratio. The primary outcome was the time taken to achieve meaningful pain relief (MPR) from baseline using a pain visual analog scale (VAS) compared to the placebo. The secondary outcomes were the pain intensity difference (PID) and joint discomfort at 1-, 2-, 3-, and 4-hours post-product administration and the time-weighted sum of pain intensity difference (SPID) over 4 hours compared to placebo.\u0000Results: Participants in two out of eight investigational product groups achieved MPR successfully. The proprietary combination ZV-E (consisting of Z. officinale and V. negundo) showed the fastest pain reduction with more than 50% of the participants achieving meaningful relief. The BS-ZP (consisting of B. serrata + Z. officinale + P. lanceolata) group also had more than 50% of participants reporting MPR at 4 hours post-IP administration. Subsequently, the SPID was found to be lowest in the participants of above stated groups.\u0000Conclusions: The proprietary combination of Z. officinale and V. negundo extracts, 200 mg could be a promising lead to conduct a further trial to investigate its effect on joint pain.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"130 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140438356","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}
引用次数: 0
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