INSTRuCT: Protocol, Infrastructure, and Governance.

Background and Purpose: Very few large scale multicentric stroke clinical trials have been done in India. The Indian Council of Medical Research funded INSTRuCT (Indian Stroke Clinical Trial Network) as a task force project with the objectives to establish a state-of-the-art stroke clinical trial network and to conduct pharmacological and nonpharmacological stroke clinical trials relevant to the nation and globally. The purpose of the article is to enumerate the structure of multicentric stroke network, with emphasis on its scope, challenges and expectations in India. Methods: Multiple expert group meetings were conducted by Indian Council of Medical Research to understand the scope of network to perform stroke clinical trials in the country. Established stroke centers with annual volume of 200 patients with stroke with prior experience of conducting clinical trials were included. Central coordinating center, standard operating procedures, data and safety monitoring board were formed. Discussion: In first phase, 2 trials were initiated namely, SPRINT (Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in India) and Ayurveda treatment in the rehabilitation of patients with ischemic stroke in India (RESTORE [Rehabilitation of Ischemic stroke Patients in India: A Randomized controlled trial]). In second phase, 4 trials have been approved. SPRINT trial was the first to be initiated. SPRINT trial randomized first patient on April 28, 2018; recruited 3048 patients with an average of 128.5 per month so far. The first follow-up was completed on May 27, 2019. RESTORE trial randomized first patient on May 22, 2019; recruited 49 patients with an average of 3.7 per month so far. The first follow-up was completed on August 30, 2019. Conclusions: In next 5 years, INSTRuCT will be able to complete high-quality large scale stroke trials which are relevant globally. REGISTRATION: URL: http://www.ctri.nic.in/; Unique Identifier: CTRI/2017/05/008507.

Recanalized vein of marshall following bidirectional glenn surgery.

A 6-year-old boy with a case of double outlet right ventricle with large non-routable ventricle septal defect and severe pulmonary stenosis was deemed unsuitable for biventricular repair on a prior evaluation. Hence, a bidirectional Glenn (BDG) shunt was performed at 3 years of age following cardiac catheterization.

Risk factors for mortality in a south Indian population on generic antiretroviral therapy.

BACKGROUND: Antiretroviral treatment (ART) programs from low-income countries utilizing standardized ART regimens, simplified approaches to clinical decision making and basic lab monitoring have reported high mortality rates. We determined the risk factors for mortality among HIV-infected adults following the initiation of ART from a single center in south India. METHODS: ART-naive HIV-infected south Indian adults attending the Infectious Diseases clinic in a 2000-bed academic medical center in south India who were initiated on ART (generic, fixed-dose combinations) as per the national guidelines were followed up. Cases (32 patients who died) were compared with age and sex matched controls. RESULTS: Eight-hundred and twenty-two patients were started on ART from January 1, 2000 to December 31, 2008. The cumulative mortality was 6.8% (56/822). Among the cases mean age was 44 years, 18% were women and mean CD4 counts was 107 cells/microl. Among the controls mean age was 41 years, 18% were women and mean CD4 counts were 113 cells/microl. Stavudine based ART was predominant 62.5% in the cases vs 37.5% in the controls, followed by zidovudine based therapy in 31.2% of cases and 43.7% in the controls. Tenofovir based therapy was used in 6.2% of cases vs 18.7% in the controls. The commonest causes of death were drug toxicity 19%, advanced Acquired Immunodeficiency Syndrome (AIDS) in 37%, Immune Reconstitution Inflammatory Syndrome (IRIS) in 16%, non AIDS related deaths in 22% and malignancies 6%. In a univariate analysis, absolute lymphocyte count <1200 cells/cmm (p=0.03), development of immune reconstitution inflammatory syndrome (IRIS) (p=0.000) and mean CD4 cell count increase <75 cells/microl after 1 year of ART (p=0.001) were significantly associated with mortality. CONCLUSIONS: The mortality among our patients was comparable to that reported from other low-income countries. Earlier initiation of ART may reduce the high mortality rates observed.

Implementation of a Physician-Based Stroke Unit in a Remote Hospital of North-East India-Tezpur Model.

Objective The study aims to determine the effects of implementing stroke unit (SU) care in a remote hospital in North-East India. Materials and Methods This before-and-after implementation study was performed at the Baptist Christian Mission Hospital, Tezpur, Assam between January 2015 and December 2017. Before the implementation of stroke unit care (pre-SU), we collected information on usual stroke care and 1-month outcome of 125 consecutive stroke admissions. Staff was then trained in the delivery of SU care for 1 month, and the same information was collected in a second (post-SU) cohort of 125 patients. Statistical Analysis Chi-square and Mann-Whitney U test were used to compare group differences. The loss to follow-up was imputed by using multiple imputations using the Markov Chain Monto Carlo method. The sensitivity analysis was also performed by using propensity score matching of the groups for baseline stroke severity (National Institute of Health Stroke Scale) using the nearest neighbor approach to control for confounding, and missing values were imputed by using multiple imputations. The adjusted odds ratio was calculated in univariate and multivariate regression analysis after adjusting for baseline variables. All the analysis was done by using SPSS, version 21.0., IBM Corp and R version 4.0.0., Armonk, New York, United States. Results The pre-SU and post-SU groups were age and gender matched. The post-SU group showed higher rates of swallow assessment (36.8 vs. 0%, p < 0.001), mobility assessment, and re-education (100 vs. 91.5%, p = 0.037). The post-SU group also showed reduced complications (28 vs. 45%, p = 0.006) and a shorter length of hospital stay (4 ± 2.16 vs. 5 ± 2.68 days, p = 0.026). The functional outcome (modified ranking scale) at 1-month showed no difference between the groups, good outcome in post-SU (39.6%) versus pre-SU (35.7%), p = 0.552. Conclusion The implementation of this physician-based SU care model in a remote hospital in India shows improvements in quality measures, complications, and possibly patient outcomes.

Fatal cerebral abscess caused by Cladophialophora bantiana.

Primary cerebral phaeohyphomycosis is caused by pigmented fungi that exhibit distinct neurotropism often in immunocompetent individuals. A 20-yr-old male presented with multiple brain abscess which was subsequently proven microbiologically to be due to Cladophialophora Bantiana. In spite of near total excision and appropriate antifungal agents succumbed to his illness. We report this case to highlight its rarity and high mortality in an immunocompetent host. There is no initial clinical or laboratory feature that makes a preoperative diagnosis possible and relies on microbiological confirmation.