International Journal of Clinical Trials最新文献

{"title":"The understanding of epidemiology and study designs","authors":"Pranali M. Wandile","doi":"10.18203/2349-3259.ijct20232202","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20232202","url":null,"abstract":"The goal of health care systems is to keep patients healthy by monitoring, diagnosing, and treating their illnesses. These complex systems have many objectives, such as improving the quality of health care, making healthcare accessible to all people who are in need, extending people’s life span, preventing illnesses, etc. Promoting healthy lifestyles along with the prevention of illnesses to improve people’s health is also a fundamental principle of public health, and now it also become a fundamental principle of modern health care and integrating into health and social care strategies across the world. Epidemiology is the system of ultimate reasoning focused on creating and examining theories in systematic fields such as biology, physics, and behavioral sciences while rationalizing health-associated states and events so that justification for further suitable real-world public health measures can be provided. While working in the field, I observed that allied healthcare professionals lacked basic knowledge about epidemiology and related study designs. The input from this healthcare professional not only assists in building meaningful research studies but also demonstrates its powerful impact on patients’ healthcare through preventive measures and study results. The goal of this article is to provide basic knowledge of epidemiology and its various study designs in a simplistic language to allied healthcare professionals working in the field. In this article, I have described a general overview of epidemiology and various study designs, along with examples. I hope this information could be beneficial for a better understanding of epidemiology to healthcare professionals working in the field.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85933875","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":"Can definitive chemoradiation offer a cure along with cosmesis in locally advanced IVA carcinoma buccal mucosa? a case report","authors":"J. Sharma, M. Gupta, Siddharth Vats, Naina Negi","doi":"10.18203/2349-3259.ijct20232201","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20232201","url":null,"abstract":"Surgery is the mainstay of the treatment in ca buccal mucosa. It is extensive in nature and may require efficient reconstruction for good cosmetic outcome. Adjuvant radiation or chemo-radiation may be needed in advanced cancers. Definitive chemoradiation or palliative radiation are reserved for inoperable patients. We present a case report of advanced carcinoma of oral cavity in the left buccal mucosa along with involvement of retromolar trigone along with bone involvement in left sided mandible who opted out for undergoing definitive surgery. She was treated with definitive chemoradiation with 2.4 Gy per day /0.4 Gy in morning, 2 Gy in evening five days a week along with paclitaxel on Sunday. Patient reported after seven years disease free with excellent cosmetic outcome. Definitive surgery along with adjuvant radiation or chemoradiation is the standard of care in advanced cancers of buccal mucosa. However, in inoperable patients or the patients refusing surgery definitive chemoradiation with altered fractionation schedules may still offer a chance of cure and good cosmesis.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"42 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77163948","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 designs: a simplified overview","authors":"Pranali M. Wandile","doi":"10.18203/2349-3259.ijct20232153","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20232153","url":null,"abstract":"Clinical trials aim to invent new, better, safer, more effective ways to prevent, detect, or treat health conditions and to compare them to existing standards of care as applicable. This scientific inquiry prompts researchers to design and develop proposed clinical trial protocols to evaluate preliminary information about the product and develop research questions and objectives. The average budget for new product development is enormous, and this eventuality is because almost 90 percent of a trial drugs never get approved. Hence, having an appropriate clinical trial design is crucial for successful product development. A trial's ability to deliver the proposed indication relies on its suitable design, background information, the trial justification to sample size, interim monitoring rules, and ways to review and analyze study data. In this article, we presented an overview of clinical trial designs emphasizing adaptive designs in a simplified way for field-based clinical research professionals.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"38 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76722170","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":"Cross sectional study to evaluate modified Alvardo score in the diagnosis of acute appendicitis","authors":"Pramatha Nath Dutta, Ranadip Chatterjee, Tamoghna Das, Lita Bag, Purba Bhaumik","doi":"10.18203/2349-3259.ijct20231403","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20231403","url":null,"abstract":"Background: Appendectomy is one of the most commonly performed emergency operation. The diagnosis requires distinguishing from other causes of pain in that region of the abdomen like acute ureteric colic, right sided salphingoophoritis. Presently ultrasonogram and contrast enhanced CT scan are the diagnostic modalities of choice. Although these facilities are readily available in urban areas but rural areas still suffer from lack of timely diagnosis and negative appendectomy, enhancing the need for a reliable scoring system for diagnosis of acute appendicitis. Here we will evaluate modified Alvardo scoring system in diagnosis of acute appendicitis.\u0000Methods: This is an observational cross-sectional hospital-based study at KPC medical college, Kolkata with 92 consecutive cases of suspected acute appendicitis, who were admitted, investigated and treated during 1st February 2022 to 31st January, 2023. Modified Alvardo score is calculated of each patient and compared with the histopathological findings of operated appendix.\u0000Results: The above study shows that modified Alvardo score 7-9 has high sensitivity of 93.10% in men and in female sensitivity is 77.78%. Overall sensitivity of modified Alvardo score of 7-9 came out to be 83.63%.\u0000Conclusions: It can be concluded that modified Alvardo score of 7-9 can be used as a potent diagnostic tool in male. But in females due to lower sensitivity and significant number of negative appendectomy, it can be used an diagnostic aid in addition to imaging studies for diagnosis.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88746819","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":"Conducting a three-country clinical trial during the COVID-19 pandemic: experience and future considerations","authors":"Sylvia Baedorf Kassis, Weidong Lu, Sarah A. White, Anita Giobbie-Hurder, Anna M. Tanasijevic, Hyun-Jung Jung, Xiping Zhang, I. Shin, Sung-hoon Park, Young-Ju Jeong, C. Yao, J. Ligibel, Barbara E. Bierer","doi":"10.18203/2349-3259.ijct20231109","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20231109","url":null,"abstract":"The global SARS-COV-2 pandemic has significantly impacted the delivery of clinical care as well as the conduct of international clinical trials. A coordinated, multinational acupuncture study, consisting of three parallel randomized studies with a planned pooled analysis of individual patient data, was initiated in 2019 with the goal of assessing whether acupuncture relieved hot flash symptoms in hormone receptor-positive breast cancer patients prescribed adjuvant endocrine therapy. Eligibility included persistent hot flashes on endocrine therapy. Participants were randomly assigned to receive either immediate or delayed acupuncture in equal proportions; the primary endpoint was assessed at week 10, after completion of the immediate acupuncture treatments and before the delayed treatment sessions began. The trial was conducted in China, South Korea and United States of America (USA) and was in the midst of enrollment and study procedures when the COVID-19 pandemic began. Despite numerous challenges, the study was nonetheless completed successfully. We deployed a process evaluation method to describe each site’s experiences in conducting this multinational study during the pandemic. Using these observations, we offer measures for the planning and conduct of future studies, taking into account preparedness considerations in the event of exigent and demanding global circumstances.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"16 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86251617","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":"Implementation of inclisiran in United Kingdom primary care for patients with atherosclerotic cardiovascular disease or its-risk equivalents: rationale and design of Victorion-spirit, a pragmatic phase IIIb, randomised controlled study","authors":"Paul M Wilson, Samantha Dixon, Tracey Vell, P. Bower, Linda Rootkin, Claire Williams, Adam Strong, D. Lawrence, R. Elvey, Owen Williams, N. Stein, J. M. Gibson","doi":"10.18203/2349-3259.ijct20231106","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20231106","url":null,"abstract":"Background: Translational gaps exist in implementing health innovations rapidly in clinical practice. Pragmatic effectiveness and implementation studies, therefore, play a pivotal role in understanding how high-value health innovations could be deployed and delivered in healthcare systems to reduce barriers to adoption and provide more rapid patient benefit. Victorion-spirit is an ongoing pragmatic, 9-month, phase IIIb, open-label, multicentre, randomised controlled study evaluating the implementation, patient experience, and delivery of the subcutaneous lipid-lowering therapy, inclisiran sodium 300 mg, in participants with elevated low-density lipoprotein cholesterol (LDL-C) who are on established lipid-lowering medication, or have been recommended lipid-lowering therapy, but are unable to tolerate treatment.\u0000Methods: Victorion-spirit utilises a type 1 hybrid effectiveness-implementation design, where the primary objective is to demonstrate superiority of inclisiran with or without (±) behavioural support versus standard of care (SOC; e.g., statin and/or other lipid-lowering therapies) + behavioural support in terms of percentage reduction in LDL-C from baseline to Day 270 in a primary care setting. Secondary objectives will evaluate implementation of inclisiran ± behavioural support versus SOC + behavioural support through assessment of patient satisfaction and patient activation/empowerment after treatment at Day 90; adherence to cardiovascular disease self-management; and serious adverse event profile. Additionally, a process evaluation ascertaining the views of patients, providers and national health service (NHS) commissioners will explore barriers and enablers to integrating inclisiran within primary care.\u0000Conclusions: The results of Victorion-spirit have potential to change our approach to lipid management and inform further implementation efforts in healthcare systems, such as the NHS.\u0000Trial registration: ClinicalTrials.gov NCT04087400.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"36 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72759734","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":"Effect of massage made with aromatherapy oil after mastectomy on acute arm pain and anxiety: a randomized controlled study protocol","authors":"Muzeyyen Ataseven, Nuray Şahin Orak","doi":"10.18203/2349-3259.ijct20231107","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20231107","url":null,"abstract":"Background: This article summarizes the study protocol currently used to evaluate the efficacy of aromatherapy massage for the relief of post-mastectomy anxiety and acute arm pain.\u0000Methods: It is a prospective interventional type three-group, randomized controlled, drug-free clinical trial. Eligible patients will be randomly assigned to one of three groups. The population of the study will consist of 90 patients who have undergone simple mastectomy (SM) and modified radical mastectomy (MRM) in the general surgery ward of a training and research hospital in Turkey. After the operation, the arm on the operated side will be massaged with sesame oil in the first group (n=30), sesame-lavender oil in the second group (n=30), and paraffin oil in the third group (n=30).\u0000Conclusions: The primary outcome is the level of acute arm pain and the level of state anxiety. The secondary outcome is vital signs and analgesic use status.\u0000Trial registration: International standard randomized controlled trial number NCT05658367.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"53 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81110042","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":"The effect of technology on the occurrence of musculoskeletal disorders in students of high school in Greece","authors":"Eleftheria Synolaki, Konstantinos Chandolias, A. Hristara-Papadopoulou, Ilias Kallistratos, Amalia Mathioudaki, Marianna Antonaki","doi":"10.18203/2349-3259.ijct20231102","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20231102","url":null,"abstract":"Background: There has been a rise in the proliferation of technological devices across the globe. Many children use electronic devices from the age of 3 years old, especially mobile phones. The prolonged use of electronic devices has led to a distortion of body posture, leading to musculoskeletal disorders, including neck, thoracic, and back pain, and tendonitis of the upper extremities, primarily when using one hand.\u0000Methods: To prove the positive correlation between technology and musculoskeletal disorders and to answer the above questions, an online questionnaire was distributed to 120 students of high school from all over Greece. The questionnaire comprises questions from two standardized questionnaires, the internet addiction test (IAT) and the Nordic musculoskeletal questionnaire (NQS). In addition, respondents completed a medical history and supplementary questions about their physical condition and their attitudes when using electronic devices.\u0000Results: The results show that there is a positive correlation between long-term use of electronic devices and the occurrence of musculoskeletal problems in all parts of the body (neck, chest, lower back, hip, and lower extremities), as well as students who chose the wrong postures, had much more symptoms in contrast to the students who chose the positions with the greatest alignment. Finally, physical activity decreased significantly as the respondents' hours of using electronic devices increased.\u0000Conclusions: Uncontrolled use of electronic devices can be a factor in the onset of symptoms, but adopting correct posture while using the devices and the good physical condition of the students would significantly reduce pain.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"88 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74841247","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":"A multi-center, randomized, controlled, phase-2/3 study to evaluate the safety and immunogenicity of inactivated Japanese encephalitis vaccine in healthy ≥1 to <3 years old Indian children","authors":"S. Thuluva, K. Turaga, S. G. V., Rammohan Reddy M., V. Yerroju, P. Suneetha, Ramesh V. Matur","doi":"10.18203/2349-3259.ijct20231104","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20231104","url":null,"abstract":"Background: Japanese encephalitis (JE) is endemic in various parts of India. Due to the limited treatment options available, a new treatment option that is safe and effective is highly expected for the existing medical needs.\u0000Methods: In the present randomized Phase-2/3 study, safety, immunogenicity, and reactogenicity of JE-vaccine manufactured by Biological E (BE-JE), given in 2-dose schedule, 28-days apart was assessed in 456 healthy ≥1 to <3-year-old children compared to a licensed JE-vaccine with 3-dose schedule manufactured by Green-cross-corporation (GCC-JE).\u0000Results: The BE-JE group demonstrated non‑inferiority compared to GCC-JE group at day-56 as the lower confidence limit of the group difference was not ≥‑10%. At day-56, the geometric mean titre values were significantly higher in BE-JE group compared with the GCC‑JE group (217.97 vs 125.85; p=0.0023). No apparent difference was seen in the safety-profile between both vaccine groups, with all events reported being either mild or moderate in intensity. Also, no significant difference (p=0.2198) was reported in the number of subjects experiencing at least one adverse-event (AE) between both groups.\u0000Conclusions: The present study demonstrated BE‑JE’s Vero-cell‑based inactivated JE-vaccine, administered in 2-dose schedule to be immunogenic, well-tolerated, and non-inferior, compared to GCC‑JE-vaccine, administered in a 3‑dose schedule in the pediatric Indian-population.\u0000This study was prospectively registered with clinical trial registry of India bearing no CTRI/2011/091/000108 on 14/02/2011.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"93 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80469000","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":"Health seeking behavior of in tuberculosis patients during COVID-19 pandemic and lockdown in a tertiary care center","authors":"A. Periasamy, Yazhlini .","doi":"10.18203/2349-3259.ijct20231105","DOIUrl":"https://doi.org/10.18203/2349-3259.ijct20231105","url":null,"abstract":"Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in India in 2020 having originated from China in late 2019. There is no study on the impact of covid management burden on tuberculosis (TB) management. Study on the effect of lockdown on TB management is also unknown. This is a pilot study.\u0000Method: It is hypothesised that only people who are severely symptomatic will get tested for TB and severely sick patients will get admitted during the lockdown period. Data from outpatient TB clinic and inpatient ward were analysed.\u0000Results: During the lockdown of 5 months saw severe fall in the attendance of the outpatient to 727 patients which was almost 44.44% of the pre lockdown patients, sputum positive among them were 160, positivity rate was 21.69. The total inpatients admission in the lockdown period of 6 months was 130 with average of 26 per month (36% of normal). The Wald chi-square for outpatient p=0.00 with CI=43.30-63.81. The Wald chi-square test for inpatient admission p=0.00 with CI=31.66-49.52. The results of inpatients admission showed that only sick and serious patients approached hospital in the lockdown period.\u0000Conclusions: The results in the outpatient setting showed that mild to moderate symptomatic patients may not seek consultation only severe cases approached healthcare leading to spread.","PeriodicalId":13787,"journal":{"name":"International Journal of Clinical Trials","volume":"61 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78731264","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}