International Journal of Clinical Trials 

About: International Journal of Clinical Trials is an academic journal published by Medip Academy. The journal publishes majorly in the area(s): Medicine & Randomized controlled trial. It has an ISSN identifier of 2349-3240. It is also open access. Over the lifetime, 295 publications have been published receiving 862 citations.

In silico clinical trials: how computer simulation will transform the biomedical industry

Abstract: The term ‘in silico clinical trials indicates the use of individualised computer simulation in the development or regulatory evaluation of a medicinal product, medical device, or medical intervention. This review article summarises the research and technological roadmap developed by the Avicenna Support Action during an 18 month consensus process that involved 577 international experts from academia, the biomedical industry, the simulation industry, the regulatory world, etc. The roadmap documents early examples of in silico clinical trials, identifies relevant use cases for in silico clinical trial technologies over the entire development and assessment cycle for both pharmaceuticals and medical devices, identifies open challenges and barriers to a wider adoption and puts forward 36 recommendations for all relevant stakeholders to consider .

Design and rationale of the effect of early nutritional therapy on frailty, functional outcomes and recovery of malnourished medical inpatients trial (EFFORT): a pragmatic, multicenter, randomized-controlled trial

Abstract: Background: Malnutrition is highly prevalent and strongly associated with clincial outcomes of medical inpatients. Still, the benefit of nutritional treatment to prevent adverse outcomes in medical inpatients at risk for malnutrition remains unproven. We describe the trial methods of the largest yet nutritional trial in medical inpatients including the rationale for key design decisions regarding the nutritional strategy, eligibility criteria, choice of control arm, and endpoints. Methods: The Effect of early nutritional therapy on Frailty, Functional Outcomes and Recovery of malnourished medical inpatients Trial (EFFORT) is an investigator-initiated, non-commercial, open-label RCT to compare the effects of an intensified nutritional therapy (intervention group) with a control group on medical outcomes. We include adult medical inpatients at risk of malnutrition based on a Nutritional Risk Screening 2002 (NRS) score of ≥3 points with an expected length of stay of ≥5 days. An individualized systematic nutritional assessment by study dieticians is done to define nutritional targets and to establish an implementation plan. Patients in the intervention group receive individualized early nutritional therapy based on a previously published consensus algorithm, while control group patients receive standard hospital nutrition. The study is powered to compare clinical outcomes (composite adverse outcome and mortality) in the 2 study arms as well as to address several mechanistical questions. Conclusion: EFFORT aims to close important gaps in the literature regarding the controversy about benefit and possible harm of nutritional therapy in medical inpatients at risk for malnutrition. Trial Registration: ClinicalTrials.gov NCT02517476; registered July 30, 2015.

Investigation on nutrition status and clinical outcome of patients with common cancers in Chinese patients: a multicenter prospective study protocol

Abstract: Background: Malnutrition is common in patients with cancer, which adversely affects the survival and quality of life of cancer patients. However, there is no national data on the prevalence of malnutrition in Chinese cancer patients. This study aims to evaluate the prevalence of malnutrition and quality of life (QOL) of Chinese patients with local regional, recurrent or metastatic cancer, to address the prognostic value of nutritional status and QOL on the survival of cancer patients in China and to validate the patient-generated subjective global assessment (PG-SGA) questionnaire in Chinese cancer patients. Methods: This is an observational, multi-centered, and hospital-based prospective cohort study. We aimed to recruit 50,000 cancer patients (age 18 and above) over an 8-year period. Data collection will occur within 48 hr after patients are admitted to hospital, 30-days after hospital admission, and the follow-up will be conducted 1-8 years after enrolment. The primary outcome is overall survival, and secondary outcomes are length of hospital stay and hospital costs. Factors measured are demographic characteristics, tumor characteristics, anthropometry measurements, hematological measurement, body composition, PG-SGA scores, Karnofsky performance status scores, and QLQ C30 scores. This protocol was approved by local ethical committees of all the participant hospitals. Conclusions: This multi-centered, large-scale, long-time follow-up prospective study will help diagnose malnutrition in cancer patients in China, and identify the related risk factors associated with the negative outcomes. The anticipated results will highlight the need for a truly scientific appraisal of nutrition therapy, and help to improve outcomes among cancer patients in China. Trial Registration: The trial has been registered with the Chinese Clinical Trial Registry, ChiCTR1800020329. Registered on 19 December 2018.

A multicenter, prospective, randomized study protocol to demonstrate the superiority of a bone-anchored prosthesis for anular closure used in conjunction with limited discectomy to limited discectomy alone for primary lumbar disc herniation

Abstract: Background: Same-level reherniation and progressive degeneration with disc height loss are main causes of poor outcome after discectomy and may necessitate reoperation. A novel prosthesis for anular closure was developed to address these causes. Methods: The design of a multicenter, prospective, randomized, post-market superiority trial comparing limited lumbar discectomy augmented with this device (intervention group) with limited lumbar discectomy alone (control group) is presented. Results: Patients with single-level (L1-S1) posterior or posterolateral disc herniation and radiologic confirmation of neural compression for whom at least six weeks of conservative treatment has failed are eligible. Patients must have posterior disc height ≥5 mm at index level and baseline Oswestry and VAS leg pain scores of ≥40/100. Intraoperatively, subjects meeting anular defect size criteria post-discectomy (4-6 mm tall and 6-10 mm wide) will be randomized to study groups in a 1:1 ratio using centralized, web-based software. A Bayesian statistical approach will be used to enroll 400 to 800 subjects who will be followed for at least 24 months. Two co-primary endpoints will be assessed at 24 months: 1) a composite of leg pain, clinical function, disc height maintenance, and absence of reherniation, reoperation, and device failure; and 2) absence of reherniation based upon independent radiologic analysis. Conclusions: This type of analysis is becoming increasingly important as governments and health insurers continue to be pressured to spend limited healthcare funding wisely.

A retrospective study of clinical profile of stroke patients from GMERS Medical College and Hospital, Gandhinagar, Gujarat

Abstract: Background: The cerebrovascular stroke is one of the leading causes of morbidity & mortality in adult life. After coronary heart disease & cancer of all types, stroke is the third commonest cause of death worldwide. Indian studies have shown a stroke prevalence of 471.58/100000 population. The objective was to study the clinical presentation, risk factors, neurological presentation, pattern of brain strokes, areas of brain affected as per CT scan findings in pts GMERS medical college and hospital Gandhinagar. Methods: This is a retrospective study of all new patients managed for stroke in the medical ward of GMERS medical college and hospital, Gandhinagar, Gujarat from January1, 2012 to December 31, 2013. Results: The cerebrovascular strokes are more common in males (59.7%) than females (40.3%). Most common age group was 61-70 years (32.8%). Most common clinical feature was hemiplegia (72.6%). Most common risk factor was Hypertension (34%) followed by past h/o cerebrovascular stroke (15%), smoking (14%), dyslipidemia (13%). Most common type of stroke was ischemic (74.6%) & hemorrhagic was 2 nd (22.9%). In ischemic stroke most common involved areas were parietal (33.7%), frontal (16.7%). In hemorrhagic stroke most common site was thalamus (24.7%) followed by ventricular (17.5%). Conclusions: The cerebrovascular stroke cases were having male predominance with Hypertension was the most common risk factor and most common type of stroke was ischemic.