International Journal of Clinical Trials最新文献_第10页

Predicting antipsychotic-induced weight gain in first episode psychosis-a protocol for a field-wide systematic review of prognostic factor studies 预测首发精神病患者抗精神病药物引起的体重增加——一项对预后因素研究的全领域系统回顾的方案

International Journal of Clinical Trials Pub Date : 2022-10-26 DOI: 10.18203/2349-3259.ijct20222691

Ita Fitzgerald, Erin K. Crowley, Amy Byrne, J. O’Connell, J. Ensor, Ciara Ní Dhubhlaing, S. O’Dwyer, L. Sahm

{"title":"Predicting antipsychotic-induced weight gain in first episode psychosis-a protocol for a field-wide systematic review of prognostic factor studies","authors":"Ita Fitzgerald, Erin K. Crowley, Amy Byrne, J. O’Connell, J. Ensor, Ciara Ní Dhubhlaing, S. O’Dwyer, L. Sahm","doi":"10.18203/2349-3259.ijct20222691","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222691","url":null,"abstract":"Background: One significant complexity associated with management of antipsychotic-induced weight gain (AIWG) is extensive interindividual variability amongst patients in initial susceptibility to AIWG, time to plateau of weight gain, and resultant final amount of weight gained. Prior to antipsychotic commencement, risk-stratified information highlighting those at increased risk of experiencing significant AIWG would allow tailored weight monitoring and subsequent management protocols to be developed.Methods: This protocol is for a planned systematic review to identify the current utility of baseline clinical, sociodemographic, and biological prognostic factors in predicting the likelihood of significant AIWG occurring prior to antipsychotic commencement. The cohort assessed will be antipsychotic-naïve adults with a first episode of psychosis. Searches for both randomised and prospective non-randomised studies will be undertaken by searching four electronic databases and two trial registers, followed by reference searching, forward citation searching and liaison with content experts. A meta-analysis of study results will be undertaken where study quality and homogeneity allow. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework modified for prognostic research will be used to assess evidence certainty. This protocol was prepared in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) Protocols guideline and latest guidance from the Prognosis Methods Group of the Cochrane Collaboration.Results: This review will establish the current quantity, quality and clinical utility of evidence addressing the prognostic association of clinical, biological, and sociodemographic factors in prospectively identifying those more likely to experience significant AIWG.Registration details: PROSPERO registration number CRD42021258148.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87001228","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: 1

Fitness in recovery: impact of exercise in people with substance use disorder in residential treatment 康复中的健身:运动对住院治疗中物质使用障碍患者的影响

International Journal of Clinical Trials Pub Date : 2022-10-26 DOI: 10.18203/2349-3259.ijct20222688

Rhiannon Dowla, C. Stubley, B. Murnion, E. Cayanan, Y. Mavros, Scarlett Hardy, K. Rooney

{"title":"Fitness in recovery: impact of exercise in people with substance use disorder in residential treatment","authors":"Rhiannon Dowla, C. Stubley, B. Murnion, E. Cayanan, Y. Mavros, Scarlett Hardy, K. Rooney","doi":"10.18203/2349-3259.ijct20222688","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222688","url":null,"abstract":"Background: Opioid use disorder has the lowest quality of life (QOL) and highest disease burden of all substance use disorders (SUD). While opioid treatment does lead to initial improvements in QOL it remains below that of the general population. The integration of exercise programs as an adjunct therapy for SUD is gaining popularity. Previous reviews have indicated that exercise offers significant benefits for QOL, however the evidence in an opioid treatment population is lacking. This study will investigate the impact of a 12-week exercise intervention on QOL and mood in a residential opioid treatment rehabilitation program.Methods: This is a 12-week single arm intervention with a natural history control. Participants will complete a baseline screening assessing QOL, mood and exercise habits and those who meet criteria for exercise participation will complete an exercise assessment. The exercise program will be delivered twice per week as part of the group therapy program. Exercise sessions will run for approximately 40 minutes and be at an intensity selected by each of the participants.Conclusions: A recent review indicated that two sessions of exercise for a minimum of 12 weeks leads to an improvement in QOL in general SUD, however, to date minimal studies have been completed in people receiving opioid agonist treatment. Hence, this will be the first study to our knowledge, assessing the role of exercise as an adjunct treatment for QOL in this population.Trial Registration: This trial has been registered with the Australian New Zealand clinical trials registry ACTRN12622000213741.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81463848","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

Real-world utilization and acceptance of biosimilar bevacizumab in metastatic colorectal cancer in India 贝伐单抗生物仿制药在印度转移性结直肠癌中的实际应用和接受度

International Journal of Clinical Trials Pub Date : 2022-10-10 DOI: 10.18203/2349-3259.ijct20222626

L. Patel, Shreekant Sharma, D. Bunger

{"title":"Real-world utilization and acceptance of biosimilar bevacizumab in metastatic colorectal cancer in India","authors":"L. Patel, Shreekant Sharma, D. Bunger","doi":"10.18203/2349-3259.ijct20222626","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222626","url":null,"abstract":"Background: To describe the patient characteristics and usage pattern of biosimilar bevacizumab for the treatment of metastatic colorectal cancer (mCRC) in India.Methods: This real-world, retrospective analysis included adult patients receiving biosimilar bevacizumab between April 2021 and March 2022.Results: A total of 1125 patients with mCRC who received biosimilar bevacizumab-based chemotherapy were included. The mean age at diagnosis was 57.8 years. Majority of the patients were males (71%) and belonged to the age groups of 41-76 years. The primary tumor site was right colon (52.6%) followed by left colon (29.2%) and rectum (17.3%), and the tumor grade was reported as high in most (88.7%) of the patients. Majority of patients received biosimilar bevacizumab-based chemotherapy as first-line therapy (61.3%), followed by second-line (31.9%) and third-line therapy (6.8%). In combination with biosimilar bevacizumab, FOLFOX (folinic acid, 5-fluorouracil, and oxaliplatin) was the most commonly administered regimen (42.9%), followed by CAPOX (capecitabine and oxaliplatin, 26.5%) and FOLFIRI (folinic acid, 5-fluorouracil, and irinotecan, 22.8%).Conclusions: Biosimilar bevacizumab-based chemotherapy is being widely used in real‑world clinical setting in India for the management of patients with mCRC.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77731727","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

Long-term efficacy and safety of RazumabTM (biosimilar ranibizumab) in Indian patients with retinal diseases: results from retrospective REAR RD-2 study RazumabTM(雷尼单抗生物仿制药)在印度视网膜疾病患者中的长期疗效和安全性:来自REAR RD-2的回顾性研究结果

International Journal of Clinical Trials Pub Date : 2022-10-01 DOI: 10.18203/2349-3259.ijct20222610

Shashikant Sharma, A. Chaturvedi, N. Dave, Ankita Shah

{"title":"Long-term efficacy and safety of RazumabTM (biosimilar ranibizumab) in Indian patients with retinal diseases: results from retrospective REAR RD-2 study","authors":"Shashikant Sharma, A. Chaturvedi, N. Dave, Ankita Shah","doi":"10.18203/2349-3259.ijct20222610","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222610","url":null,"abstract":"Background: To evaluate risk factors associated with retinal diseases and efficacy and safety of RazumabTM (biosimilar ranibizumab) in the management of retinal diseases in Indian patients with wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV).Methods: In the retrospective, observational REAR RD-2 study, all patients with retinal diseases who were treated with biosimilar ranibizumab were included from multiple Indian sites. The demographic parameters, disease characteristics and treatment details were recorded. Efficacy assessments included improvement in best corrected visual acuity (BCVA), and decrease in central subfield thickness (CSFT), intra-retinal fluid (IRF) and sub-retinal fluid (SRF) from baseline to week 48.Results: Data of 1422 patients (wet AMD-27.57%; DME-30.7%, RVO-33.47%; mCNV-5.48%), who were treated with biosimilar ranibizumab, was analyzed. The most common age group of patients was 61-70 years (36.6%). The most common ocular risk factor identified was glaucoma (24.90%). A total of 85.72% patients were treatment naïve and 14.28% were previously treated patients. Biosimilar ranibizumab treatment resulted in significant (p<0.05) improvements in the mean BCVA and CSFT, and the proportion of patients with IRF and SRF was significantly reduced throughout the treatment. No new safety concerns with biosimilar ranibizumab were observed.Conclusions: Retinal diseases are more common in the age group of 61-70 years. Glaucoma was the most common ocular risk factor identified for retinal diseases. Long-term treatment with biosimilar ranibizumab was effective and well-tolerated in retinal diseases including wAMD, DME, RVO and mCNV in real-world Indian scenario. ","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79428508","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

Ergonomics in oral health professions: a mapping review protocol 口腔卫生专业的人体工程学:一种绘图审查方案

International Journal of Clinical Trials Pub Date : 2022-09-27 DOI: 10.18203/2349-3259.ijct20222549

Shiba Roby, Z. Morse

{"title":"Ergonomics in oral health professions: a mapping review protocol","authors":"Shiba Roby, Z. Morse","doi":"10.18203/2349-3259.ijct20222549","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222549","url":null,"abstract":"Background: Ergonomics is a multidisciplinary science that studies how humans and other system elements interact and a profession that uses theory, concepts, data, and methodologies to improve human well-being and overall system performance. Oral health professionals need good working ergonomics to preserve their work competence, efficiency, and high clinical level of treatment throughout their careers. For various working practices, clinical procedures, and patient types, they must adjust and ensure proper working postures, adequate illumination, and easy access to essential apparatus and materials. Although some systematic studies and original research have been conducted about different aspects of “ergonomics in oral health professions,” no mapping review has been shown. The authors believe a broad overview of existing literature is required to map existing research, determine research gaps, and guide future research.Methods: The protocol for this mapping review has been designed by the Preferred Reporting Items for Systematic reviews and Meta-Analysis extension for scoping studies (PRISMA-SCR) and the Joanna Briggs Institute (JBI) guidelines. A comprehensive search strategy developed with an experienced liaison librarian for health will be used to search four databases and eight sources of unpublished literature. JBI’s proposed search approach will be used. A PRISMA-SCR flowchart will be used to track the number of recognised, screened, and excluded sources. A data extraction table will be used to collate critical information, supplemented with a narrative explanation, and presented in a tabular style.Conclusions: This mapping review will identify research gaps in this field and guide further studies.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85273664","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 mapping review protocol for toothbrush design 牙刷设计的绘图审查程序

International Journal of Clinical Trials Pub Date : 2022-09-22 DOI: 10.18203/2349-3259.ijct20222376

Smruti Divate, Z. Morse

{"title":"A mapping review protocol for toothbrush design","authors":"Smruti Divate, Z. Morse","doi":"10.18203/2349-3259.ijct20222376","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222376","url":null,"abstract":"Background: A universal method of dental home care regimen has been toothbrushing. It aids with dental biofilm and plaque removal in an attempt to prevent chronic oral diseases. Although many comparative studies have been conducted on toothbrushes and their efficacy in plaque removal, there has been no systematic mapping review focusing on toothbrush design, ease of use and safety. This mapping review aims to map key concepts, categorise existing themes and identify gaps in existing literature for future primary or scoping studies.Methods: The protocol for this mapping review has been designed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) and the Joanna Briggs Institute (JBI) guidelines. Primary and secondary studies, guidelines, and reports about the design, ease of use and safety of toothbrushes will be considered for inclusion in this mapping review. Four databases (Dentistry and Oral Sciences Source, CINAHL, MEDLINE, and Scopus) and three sources of unpublished literature (Cochrane Library, Google, and Google Scholar) will be searched using the JBI proposed three-stage search strategy by reviewers independently. A PRISMA-ScR flowchart will be utilised to document the numbers of identified, screened, and excluded sources. Data will be extracted using a data extraction table designed by the reviewers. Extracted data will be summarised and presented in diagrammatic and tabular forms, accompanied by a narrative explanation.Conclusions: Examining the existing literature on toothbrush design is fundamental to guide future research, design innovations, and improve oral health.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76772700","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 randomized observational study into the pattern of hearing loss in chronic suppurative otitis media 慢性化脓性中耳炎听力损失模式的随机观察研究

International Journal of Clinical Trials Pub Date : 2022-08-05 DOI: 10.18203/2349-3259.ijct20222070

Sucheta Gupta, V. Gupta

{"title":"A randomized observational study into the pattern of hearing loss in chronic suppurative otitis media","authors":"Sucheta Gupta, V. Gupta","doi":"10.18203/2349-3259.ijct20222070","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20222070","url":null,"abstract":"Background: Chronic suppurative otitis media (CSOM) is an important and a highly prevalent disease of the middle ear and poses serious health problem worldwide especially in developing countries. The objective of the current study was to evaluate the association between CSOM and sensorineural hearing loss (SNHL) and to study of pattern of hearing loss and clinical factors and demographic variables, if any, that might affect sensorineural component, in CSOM in North-Indian population.Methods: A randomized observational study was conducted on 120 patients, in the age-group of 1 to 50 years, divided into two groups of 60 each: who had safe CSOM and unsafe CSOM, over a period of 6 months, i.e., from: July 2021 to December 2021, in the department of otorhinolaryngology and head neck surgery, CHC, Chenani, Udhampur, J and K, India.Results: Out of 60 patients under safe CSOM, Male: Female ratio stood at 1:1.14 (i.e., 28:32). Mean duration ± SD of the disease stood at: 6.2±5.09 years. Incidence of hearing loss was observed in 93 (77.5%) patients of conductive type and 27 (22.5%) patients of mixed type and 19 patients (31.67%) were of unsafe mixed type. Maximum incidence of 35% was in the age group of 41-50 years and minimum in 11-20 years i.e., 7.32%. Total incidence of SNHL 16.67%.Conclusions: A significant association between SNHL and CSOM was found in this study, with incidence of SNHL increasing with advancing age, showing that age as a risk factor for sensorineural component of hearing loss in CSOM.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85747879","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

Caries prevention during removable orthodontic treatment: a scoping review protocol 可摘正畸治疗期间的龋齿预防:范围审查方案

International Journal of Clinical Trials Pub Date : 2022-07-26 DOI: 10.18203/2349-3259.ijct20221869

Hyunjin Park, Z. Morse

{"title":"Caries prevention during removable orthodontic treatment: a scoping review protocol","authors":"Hyunjin Park, Z. Morse","doi":"10.18203/2349-3259.ijct20221869","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20221869","url":null,"abstract":"Background: Removable orthodontic treatment corrects dental and skeletal malocclusion by utilising various types of removable appliances. Although removable orthodontic treatment has a reduced risk of dental caries compared to fixed orthodontic treatment, removable appliances create niches for cariogenic microorganisms to increase their numbers and lead to an ecological shift. However, there is insufficient information on caries prevention during removable orthodontic treatment. The protocol details the research for a scoping review of caries prevention during removable orthodontic treatment.Methods: This scoping review will be conducted according to the Preferred Reporting Items for Systemic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) and Joanna Briggs Institute (JBI) Manual for Evidence Synthesis guidelines. Published primary and secondary research studies (including reviews), guidelines, websites, and reports that are written in English until April 2022 will be searched from seven databases, including Dentistry and Oral Sciences Source, CINAHL, MEDLINE, via EBSCOHost, Scopus, Cochrane, Google, and Google Scholar. Two reviewers (HP and ZM) will analyse the retrieved articles simultaneously using the parameters and three-step strategy recommended by JBI. Obtained numbers of included and excluded identified sources will be presented in a PRISMA flow diagram and the data extraction table will demonstrate the variables from included sources.Conclusions: The findings of this review will be summarised in a narrative description to facilitate guidance in clinical practice and research for health professionals.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80050534","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

Single-centre, randomized, clinical trial of opioid-free analgesia versus routine opioid-based analgesia regimen for the management of acute post-operative pain following caesarean section: study protocol 无阿片类药物镇痛与常规阿片类药物镇痛方案治疗剖宫产术后急性疼痛的单中心随机临床试验:研究方案

International Journal of Clinical Trials Pub Date : 2022-07-26 DOI: 10.18203/2349-3259.ijct20221870

Olakunle I. Makinde, S. Aigere, N. Oyeyemi, A. Adesina

{"title":"Single-centre, randomized, clinical trial of opioid-free analgesia versus routine opioid-based analgesia regimen for the management of acute post-operative pain following caesarean section: study protocol","authors":"Olakunle I. Makinde, S. Aigere, N. Oyeyemi, A. Adesina","doi":"10.18203/2349-3259.ijct20221870","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20221870","url":null,"abstract":"Background: Pain management post-caesarean section is a common source of exposure to opioids in women. To address the rising opioid addiction associated with peri-operative administration, trend in operative analgesia is moving towards opioid-free, multimodal analgesia. We present our protocol for this study so that it may be replicated in other settings and possibly modified for future studies.Methods: In a Single-centre, non-inferiority, parallel, randomized, controlled, clinical trial with balanced allocation [1:1] into two arms, we compared a peri-operative opioid-free analgesia regimen with a routine post-operative opioid-based analgesia regimen in women undergoing caesarean section under spinal anaesthesia. Primary outcome measures were post-operative pain intensity at 4, 8 and 24 hours (using Numerical Rating Scale) and post-operative pentazocine use. Secondary outcome measures were the incidence of adverse events and Apgar score. Results will be published in a peer-reviewed, open access journal.Conclusions: This protocol adopted the use of intravenous paracetamol and intravenous NSAID as baseline analgesics. Magnesium sulphate was introduced peri-operatively as part of our opioid-free multimodal analgesia regimen because of its established effect in decreasing post-operative pain and opioid use. We also relied on the preventive analgesic effect of administration of intravenous paracetamol and intravenous magnesium sulphate before surgical incision, continued intraoperatively and post-operatively. In addition, magnesium sulphate is a familiar drug to the obstetrician, readily available and affordable in most settings where comprehensive emergency obstetric care is offered, easy to administer and it has been well tolerated clinically.Trial registration: This protocol was registered with clinicaltrials.gov (Identifier: NCT04539249) on September 3, 2020, prospectively.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88209825","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

Long-term effect of subcutaneous treprostinil in patients with pulmonary hypertension: rationale and design of the phase IV, multicentre, observational TREPAR-HP study 肺动脉高压患者皮下treprostiil的长期疗效:多中心观察性TREPAR-HP IV期研究的基本原理和设计

International Journal of Clinical Trials Pub Date : 2022-07-26 DOI: 10.18203/2349-3259.ijct20221868

A. Lescano, N. Atamañuk, G. Bortman, J. Cáneva, M. Diez, G. Giacomi, L. Lema, E. Perna

{"title":"Long-term effect of subcutaneous treprostinil in patients with pulmonary hypertension: rationale and design of the phase IV, multicentre, observational TREPAR-HP study","authors":"A. Lescano, N. Atamañuk, G. Bortman, J. Cáneva, M. Diez, G. Giacomi, L. Lema, E. Perna","doi":"10.18203/2349-3259.ijct20221868","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20221868","url":null,"abstract":"Background: Pulmonary hypertension (PH) is a chronic, progressive condition with high morbidity and mortality due to right heart (RH) failure. Prognosis depends on RH adaptability and remodelling in response to increased pulmonary arterial pressure. There is little information regarding risk variables and prognostic factors in the Argentinian population, current risk scores have not been validated, and its impact on free-event survival is still unknown. Prostacyclin analogues are the first-line treatment for high-risk patients. However, there is limited evidence on its clinical benefits, long-term effects, and impact on RH remodelling in the Argentinian population.Methods: The study was designed as a national, multicentre, prospective, observational, phase IV study including 100 patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension, treated with subcutaneous treprostinil and followed up for 48 months. The study will be conducted in parallel with the patients' standard management and treatment in each centre. The primary objective is to assess the long-term improvement or reversal of RH remodelling (RHRR) parameters obtained by echocardiography. Secondary objectives include the evaluation of the prognostic value of RHRR parameters and the rate of clinical events, the treatment effect in terms of pulmonary vascular resistance, right ventricle systolic function, morbidity and all-cause mortality, quality of life, and safety and tolerability.Conclusions: This study will help to determine the clinical benefits, long-term effects, and impact on RH remodelling of prostacyclin analogues in Argentina.Trial registration: The trial was registered at Registro Nacional de Investigaciones en Salud (RENIS) in Argentina (https://sisa.msal.gov.ar/sisa/#sisa; registration number IS003303).","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87445991","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