Safety of Procalcitonin Guided Early Discontinuation of Antibiotic Therapy among Children Receiving Cancer Chemotherapy and Having Low-Risk Febrile Neutropenia: A Randomized Feasibility Trial (ProFenC Study).

In low-risk febrile neutropenia (LR-FN), the safety of early discontinuation of empiric antibiotics without marrow recovery is not well established. This study aimed to evaluate the safety of procalcitonin (PCT) guided early discontinuation of antibiotics in LR-FN. In this trial, children with LR-FN with an afebrile period of at least 24 h, sterile blood culture, and negative/normalized PCT were randomized at 72 h of starting antibiotics into two groups: intervention arm and standard arm. The antibiotics were stopped in the intervention arm regardless of absolute neutrophil count (ANC), while in the standard arm, antibiotics were continued for at least 7 days or until recovery of ANC (>500/mm3). The primary objective was to determine the treatment failure rates, and the secondary objective was to compare the duration of antibiotics and all-cause mortality between the two arms. A total of 46 children with LR-FN were randomized to either the intervention arm (n = 23) or the standard arm (n = 23). Treatment failure was observed in 2/23 (8.7%) of patients in the intervention arm compared to 1/23 (4.3%) in the standard arm [RR: 2 (95% CI: 0.19-20.6); p = 0.55]. The median duration of antibiotics in the intervention arm and standard arm were 3 days vs 7 days (P= <0.001). There was no mortality in this study. PCT-guided early discontinuation of empirical antibiotics in LR-FN is feasible. There was no significant difference observed in treatment failure between the early discontinuation of antibiotics vs standard therapy. The total duration of antibiotic exposure was significantly lesser in the discontinuation arm. Further, larger multicenter studies are needed to confirm the finding of this study.

Incident Breakthrough Seizures, Serum Matrix Metalloproteinase-9 and Perfusion Magnetic Resonance Imaging Parameters in a Cohort of Children and Adolescents With Neurocysticercosis: A Longitudinal Observational Study.

BACKGROUND: The current study estimated incident breakthrough seizures, serum matrix metalloproteinase-9 (MMP-9), and perfusion magnetic resonance imaging (MRI) parameters in five- to 18-year-olds with neurocysticercosis (NCC) from colloidal or vesicular through calcified stages over at least 24 months' follow-up. METHODS: Single, colloidal, or vesicular parenchymal NCC cases were treated with albendazole and steroids and followed at a tertiary care north Indian hospital. Serum MMP-9 was estimated in colloidal or vesicular treatment-naive state and in a subset of calcified cases at six-month follow-up. The same subset of calcified cases also underwent perfusion MRI of the brain at six-month follow-up. RESULTS: Among 70 cases, 70% calcified at six-month follow-up. Over a median follow-up of 30 months, the incidence of breakthrough seizures was 48.6% (61.2% in calcified and 19.2% in resolved, P = 0.001; 32.9% early [within six months] and 15.7% late [beyond six months], P = 0.02). Serum MMP-9 levels were higher in colloidal and vesicular compared with calcified stage (242.5 vs 159.8 ng/mL, P = 0.007); however, there was no significant association with breakthrough seizures and/or calcification in follow-up. In a subgroup of calcified cases (n = 31), the median relative cerebral blood volume on perfusion MRI in and around the lesion was lower in those with seizures (n = 12) than in those without (n = 19) (10.7 vs 25.2 mL/100 g, P = 0.05). CONCLUSIONS: In post-treatment colloidal or vesicular NCC, incident breakthrough seizures decrease beyond six months. In calcified NCC with remote breakthrough seizures, significant perilesional hypoperfusion is seen compared with those without seizures.

Efficacy and safety of zinc in the prevention of oral mucositis in children with cancer receiving intensified chemotherapy: A randomized double-blind placebo-controlled trial.

BACKGROUND AND AIMS: A limited number of safe and effective preventive options for oral mucositis (OM) are available. This randomized, double-blind, placebo-controlled trial aimed to evaluate the efficacy and safety of zinc in preventing OM in children with cancer receiving intensified chemotherapy. METHODS: Children aged 3-18 years were randomized to receive oral zinc at 1 mg/kg/dose daily for 14 days or a placebo at the same doses and schedule. The primary outcome of this study was to determine the effect of oral zinc in the prevention of OM, and secondary outcomes included any adverse effect of oral zinc, the severity and duration of OM, and the need for hospitalizations. RESULTS: A total of 90 children were randomized to either the oral zinc (n = 44) or placebo group (n = 46). The incidence of OM in the zinc group was 20.5%, while that in the placebo group was 19.6% (p = .91; risk ratio: 1.04, 95% CI 0.45-2.30). There were no significant adverse events of the drug observed. There were no significant differences between the two groups in the severity (p = .79), the mean time of onset (p = .09), the mean duration of OM (p = .18), and the need for hospitalizations (p = 1.0). CONCLUSIONS: Among children on cancer chemotherapy, there was no decrease in the incidence of OM observed with oral zinc at a dose of 1 mg/kg/day. No significant adverse events were observed with administering oral zinc. Further research is warranted to test higher doses of oral zinc with longer duration for a clinically significant effect.

Survival of Persons Living With HIV/AIDS: A Multicentric Study From India.

BACKGROUND: It has been more than 17 years since the introduction of free ART in India. At this point, it would be prudent to look at the factors associated with the survival of persons living with human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) (PLHA) who are already enrolled in the ART program. METHODS: PLHAs enrolled from antiretroviral therapy (ART) centers located in three different cities in India - Delhi, Pune and Kolkata, and were followed up at six monthly intervals monitoring the WHO stage, CD4 counts, complete blood counts, and liver and kidney function tests, for a duration of three years. RESULTS AND DISCUSSION: The incidence of mortality among HIV/AIDS patients on ART was 5.0 per 1000 patient-years (21/1410, 1.4%). Age at initiation of ART, being above 35 years, was the only significant predictor of mortality (log-rank p = 0.018). Multivariable analysis showed a significant association of an unfavourable outcome (defined as mortality or development of opportunistic infection during follow-up) with male gender (adjusted odds ratio (AOR) = 5.26, p = <0.01) and being unmarried at ART initiation (AOR = 1.39, p = 0.005). CONCLUSION: The survival of PLHA with good adherence to ART is independent of the WHO stage or CD4 counts at the initiation of ART. Initiation of ART after 35 years of age was a significant predictor of mortality.

Randomized double-blind, placebo-controlled study of topical diclofenac in the prevention of hand-foot syndrome in patients receiving capecitabine (the D-TORCH study).

INTRODUCTION: Hand-foot syndrome (HFS) is a common cutaneous side effect of capecitabine therapy. Apart from oral cyclooxygenase-2 (COX-2) inhibitor (celecoxib), there are no proven strategies for the prevention of HFS. However, celecoxib is associated with significant cardiotoxicity. To date, no study has evaluated the role of topical COX inhibitor, diclofenac. In this study, we aim to compare topical 1% diclofenac gel with placebo in the prevention of capecitabine-induced HFS. METHODS: This is a randomized, placebo-controlled, double-blind, parallel-group superiority trial: the Diclofenac Topical in Reducing Capecitabine induced HFS (D-TORCH) study. A total of 264 patients with breast and gastrointestinal malignancies will be randomly allocated (stratified by sex and type of therapy [monotherapy or combination regimen with capecitabine]) to receive either 1% topical diclofenac or placebo that will be applied over the palmar and dorsal surface of the hands twice daily whilst taking capecitabine for 12 weeks. The patients will be followed up until the end of four cycles. The primary objective of this study is to compare the effect of topical diclofenac with placebo in preventing HFS (incidence of NCI CTCAEv5.0 grade 2 or higher HFS). The secondary objective is to compare the effect of topical diclofenac with placebo on preventing all grades of HFS (incidence of NCI CTCv5.0 all grade HFS), time to develop HFS (from the start of capecitabine), patient-reported outcomes (PROs) (HF-HRQoL questionnaire), adherence with the application (self-reported), capecitabine dose changes (number of patients with dose modifications due to HFS) and safety profile (NCICTCv5.0 all grade HFS) DISCUSSION: The D-TORCH study aims to determine if 1% topical diclofenac reduces the incidence of grade 2 or higher HFS in patients receiving capecitabine. To date, there have been a lot of trials for hand-foot syndrome prevention using agents like pyridoxine, vitamin E, carvedilol, and various polyherbal formulations, but none has been found successful. If the trial meets the primary end point, 1% topical diclofenac will be the new standard of care for HFS prevention. TRIAL REGISTRATION: Clinical Trials Registry of India  CTRI/2021/01/030592 . Prospectively registered on January 19, 2021.

Hydroxychloroquine pre-exposure prophylaxis for COVID-19 among healthcare workers: Initial experience from India.

Background: Hydroxychloroquine (HCQ) had generated considerable interest for coronavirus disease 2019 (COVID-19) prophylaxis. We conducted a prospective observational study at a tertiary care hospital in India, with dedicated COVID-19 care facilities. Objectives: Primary objective was incidence of adverse effects, secondary objective being efficacy in preventing COVID-19. Methods: Healthcare workers were recruited and grouped based on voluntary HCQ prophylaxis as per national guidelines. Side effects in HCQ group were graded in accordance with national cancer institute-common terminology criteria for adverse events (NCI-CTCAE) version 5.0. At 3-7-week follow-up, groups were compared for COVID-19 exposure, symptoms development and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RT-PCR results. Results: Among 358 participants recruited, 216 (60.3%) were males and mean age was 31.2 ± 6.6 years. Chemoprophylaxis was initiated by 258 (72%) participants. After loading dose, 7 (2.7%) reported grade 2 and 1 (0.4%) grade 3 adverse effects. Discontinuation of HCQ due to side effects was reported in 11 (4.3%) participants. Electrocardiogram was done by 50 (19.4%) participants on HCQ; no abnormalities were noted. A total of 106 (41%) among those taking and 63 (63%) among those not taking HCQ were tested for SARS-CoV-2 due to influenza-like illness or significant exposure. Among all participants, 25 (6.9%, 95% confidence interval [CI] 4.3-9.6) developed COVID-19 during the study period. In the group taking HCQ, 10 (3.9%) tested positive compared to 15 (15%) in the group not taking HCQ (P < 0.001). Odds ratio with HCQ intake was 0.34 (95% CI 0.13-0.83, P = 0.01) and the number needed to treat was 12. Conclusion: HCQ is safe at the recommended dose for pre-exposure prophylaxis of COVID-19.

Sentinel Node Mapping in Early Breast Cancer: A Randomized Comparison of Fluorescein Guided All India Institute of Medical Sciences, Anurag's Technique with Technetium-99 m Sulfur Colloid Plus Methylene Blue.

Purpose: Evaluation of fluorescein along with blue dye as an affordable tracer for sentinel node biopsy in comparison with technetium + methylene blue. A randomized trial was conducted with the following objectives: (1) to demonstrate that the identification of sentinel lymph node by fluorescein + methylene blue is not inferior to the identification by Tc-99 m sulfur colloid + methylene blue and (2) to evaluate the cost-effectiveness of sentinel node biopsy by above two tracers. Subjects and Methods: One-thirty patients above age 18 years presenting with early breast cancer T1, T2, N0 breast carcinoma were randomized to undergo sentinel node biopsy by either fluorescein + methylene blue or Tc-99 m sulfur colloid + methylene blue. Results: The sentinel lymph nodes were identified in 89% in Fluorescein + methylene blue group and 90.9% with Tc-99 m sulfur colloid + methylene blue group. The trial demonstrated noninferiority of fluorescein + methylene blue as compared to isotope + methylene blue with effect size = 1; 95% confidence interval- 9.54 to + 11.54. The fluorescein + methylene blue was more cost-effective than isotope guided sentinel node biopsy. Conclusion: Fluorescein-guided sentinel node biopsy is noninferior and more cost-effective than isotope-guided sentinel node biopsy.

Impact of daily-supervised administration of a package of iron and folic acid and vitamin B12 on hemoglobin levels among adolescent girls (12-19 years): a cluster randomized control trial.

OBJECTIVE: The prevalence of anemia has remained high among Indian adolescent girls over the past decade, despite the ongoing iron and folic acid (IFA) supplementation program. This study was conducted to assess the impact of daily supplementation of a package of IFA with vitamin B12 on hemoglobin levels among adolescent girls. METHODS: A community-based cluster-randomized trial was conducted in the rural block of Faridabad District, Haryana, India in the year 2017. A total of 760 adolescent girls in the age group of 12-19 years with mild and moderate anemia were selected from government schools. Daily-supervised administration of iron and folic acid was conducted for 90 days: experimental group-IFA (iron (60 mg), folic acid (500) mcg), and cyanocobalamin (1000 mcg), control group-IFA and placebo. Hemoglobin, serum ferritin, and vitamin B12 levels were assessed at baseline and endline. RESULTS: Two-hundred adolescent girls completed 90 doses of daily supplementation. The mean hemoglobin (experimental group: 1.3 ± 1.0 g/dL, control group: 1.6 ± 1.2 g/dL, P = 0.004) and ferritin levels (experimental group: 18.6 ± 31.5 ng/mL, control group: 18.8 ± 35.0 ng/mL, P = 0.188) increased in both the control and experiment groups. Serum vitamin B12 deficiency significantly reduced to 2.5% in the experimental group and ferritin deficiency alleviated in more than 96% of the girls post intervention. CONCLUSIONS: Daily supplementation of IFA with/without vitamin B12 for 90 days eliminated iron, vitamin B12 deficiency and reduced the overall proportion of anemia by 53.5%. However, addition of vitamin B12 to IFA supplementation had no impact on improving the hemoglobin levels among adolescent girls. The present study does not recommend provision of vitamin B12 for prevention and treatment of anemia in this population group.

Panel of serum miRNAs as potential non-invasive biomarkers for pancreatic ductal adenocarcinoma.

Early-stage diagnosis of pancreatic ductal adenocarcinoma (PDAC) is difficult due to non-specific symptoms. Circulating miRNAs in body fluids have been emerging as potential non-invasive biomarkers for diagnosis of many cancers. Thus, this study aimed to assess a panel of miRNAs for their ability to differentiate PDAC from chronic pancreatitis (CP), a benign inflammatory condition of the pancreas. Next-generation sequencing was performed to identify miRNAs present in 60 FFPE tissue samples (27 PDAC, 23 CP and 10 normal pancreatic tissues). Four up-regulated miRNAs (miR-215-5p, miR-122-5p, miR-192-5p, and miR-181a-2-3p) and four down-regulated miRNAs (miR-30b-5p, miR-216b-5p, miR-320b, and miR-214-5p) in PDAC compared to CP were selected based on next-generation sequencing results. The levels of these 8 differentially expressed miRNAs were measured by qRT-PCR in 125 serum samples (50 PDAC, 50 CP, and 25 healthy controls (HC)). The results showed significant upregulation of miR-215-5p, miR-122-5p, and miR-192-5p in PDAC serum samples. In contrast, levels of miR-30b-5p and miR-320b were significantly lower in PDAC as compared to CP and HC. ROC analysis showed that these 5 miRNAs can distinguish PDAC from both CP and HC. Hence, this panel can serve as a non-invasive biomarker for the early detection of PDAC.

Rituximab added to standard chemotherapy and its effect on minimal residual disease during induction in CD20 positive pediatric acute lymphoblastic leukemia: a pilot RCT.

The use of rituximab in the treatment of pediatric acute lymphoblastic leukemia (ALL) has been evaluated but mostly this has been done in the setting of a relapsed or refractory disease. Addition of rituximab to the initial treatment regimen improves the outcomes in adult CD20 positive ALL. This study was done to study its effect on newly diagnosed CD20 positive pediatric ALL patients. Twenty pediatric patients with CD20 positive ALL were randomly assigned to receive rituximab along with standard-chemotherapy [Intervention-arm (IA)] or standard-chemotherapy alone [Standard-arm (SA)]. The absolute blast count (ABC) on day 8, flowcytometry-MRD levels in the peripheral blood (PB) on day-8, day-15 and in the bone marrow (BM) at end of induction (EOI) were the outcome variables. Baseline characteristics were comparable between the IA (n=10) and SA (n=10). Significantly lower day-8 ABC was seen in the IA (P=0.005). The day-8 PB-MRD showed lower values for the IA but the difference wasn't significant (P=0.22). There was no difference between the IA and SA for day-15 PB-MRD and EOI BM-MRD. There was no difference in the incidence of adverse effects. Rituximab added to standard-chemotherapy lead to lower day-8 ABC and lower day-8 PB-MRD in CD20 positive pediatric ALL patients. Rituximab may be beneficial in pediatric ALL treatment. Studies with larger sample size are needed for more evidence.

Spectrum of uncommon and compound epidermal growth factor receptor mutations in non-small-cell lung carcinomas with treatment response and outcome analysis: A study from India.

INTRODUCTION: Mutations in the tyrosine kinase domain of the epidermal growth factor receptor gene (EGFR) are key driver alterations in lung adenocarcinomas (ADCAs). Exon 19 deletions (exon19del) and exon 21 L858R (L858R) mutations account for 70-90 % of all such alterations and predict sensitivity to EGFR tyrosine kinase inhibitors (TKIs). However, the predictive value of uncommon and compound EGFR mutations for TKIs has not been clearly established. OBJECTIVE: To assess the spectrum of EGFR mutations in non-small-cell lung carcinoma (NSCLC), and to compare the treatment responses and outcomes among single common, single uncommon, and compound mutations. METHOD: The study was of combined retrospective (January 2010-December 2015) and prospective (January 2016-February 2020) design spanning 10 years. Tumor samples from TKI-naive NSCLC patients were tested for EGFR mutations by a qPCR-based method. Objective response rates (ORRs) and survival outcomes were analyzed. RESULT: In total, 1227 tumor samples were tested. EGFR mutations were detected in 391 samples (31.8 %), and included 79.5 % (311/391) single common (exon19del/L858R), 6.6 % (26/391) single uncommon (non-exon19del/L858R), and 13.8 % (54/391) compound mutations. Exon 20 T790M mutations were most prevalent among uncommon/compound mutations (40/391, 10.2 %). Overall, patients with single uncommon/compound mutations responded poorly to both EGFRTKI (47 % ORR) and chemotherapy (43 % ORR), with significantly shorter time to progression (median 7 months) compared to those with exon19del/L858R mutations (median 14.7 months). Patients with baseline T790M mutations (single/compound) were least responsive to EGFR TKIs (11 % ORR) and chemotherapy (27 % ORR) and showed the shortest progression-free survival compared to other uncommon and compound mutations. CONCLUSION: Approximately one fifth of EGFR-mutant patients harbor uncommon and compound mutations. Unlike those with exon19del/L858R, these patients-particularly those with baseline T790M mutations-show significantly inferior response rates to treatment (EGFR TKI or chemotherapy) and early disease progression.

Is There a Difference in Volumetric Change and Effectiveness Comparing Pedicled Buccal Fat Pad and Abdominal Fat When Used as Interpositional Arthroplasty in the Treatment of Temporomandibular Joint Ankylosis?

PURPOSE: There is limited evidence in the literature about fat grafting in the management of temporomandibular joint ankylosis (TMJA). The purpose was to investigate which interpositional fat grafting technique is superior in the operative management of TMJA. The specific aim was to compare the volumetric change and maximal mouth opening (MIO) when pedicled buccal fat or abdominal fat is interposed in patients being treated for TMJA. PATIENTS AND METHODS: A randomized controlled trial was conducted on TMJA patients divided into 2 groups: Pedicled buccal fat pad was used for interposition in group A, whereas abdominal fat was used in group B. At the end of 1 year, the volumetric change in fat was analyzed by comparing immediate postoperative and 1-year follow-up magnetic resonance imaging (MRI). MIO and re-ankylosis were recorded. Categorical variables were analyzed by the χ2 test or Fisher exact test. Continuous variables were compared using the t test and Wilcoxon signed rank test. Linear regression analysis was performed. RESULTS: A total of 36 patients (51 joints [15 bilateral and 21 unilateral]) were included, comprising 18 in group A and 18 in group B. The mean preoperative MIO measured 6.8 mm in group A and 4.2 mm in group B. The mean immediate postoperative MRI fat volume was 4.3 cm3 in group A and 10.8 cm3 in group B. One-year follow-up MRI showed a fat retention rate of 32.44% in group A and 58.17% in group B. The rate of volumetric shrinkage was 67.5% in group A and 41.9% in group B (P < .001). Analysis of variance showed a statistically significant difference between volumetric shrinkage and both treatment groups (P < .001). MIO improved to 30.6 mm in the pedicled buccal fat pad group (group A) and 41.9 mm in the abdominal fat group (group B) (P < .001). No re-ankylosis occurred in either group at 1-year follow-up. CONCLUSIONS: Our study results suggest that the percentage of retention of interposed abdominal fat at 1 year is more than that of pedicled buccal fat pad. Volumetric shrinkage is greater with buccal fat pad, which is a paradox considering the pedicled blood supply. Abdominal fat is better than pedicled buccal fat pad when used for interposition in TMJA treatment.

Urethral Instillation of Povidone-Iodine Reduces Post-Cystoscopy Urinary Tract Infection in Males: A Randomized Controlled Trial.

Office cystoscopy may be associated with urinary tract infection (UTI) in up to 10-20% of patients. Current practice of surgical part preparation in males with povidone-iodine excludes distal urethra in males, leaving a possibility for resident intra-urethral flora to cause post-procedural UTI. We designed this randomized study to assess whether additional cleaning of distal urethra with povidone-iodine solution can help reduce post-procedural incidence of UTIs in this setting. Additionally, urethral swab culture was done in the entire cohort to identify the prevalent microflora in the distal male urethra and to evaluate its role in causation of post-procedural UTI. Using a specialized urethral swab culture methodology, 85% males demonstrated some bacteria and 16% showed common uro-pathogens. 28 (14.5%) cases had post-procedure culture positive UTI. The incidence of UTI in control group (22%) was significantly more than the intervention group (7%) (p value <0.007). This result strongly supports inclusion of distal urethral irrigation with povidone-iodine in males before office cystoscopy, even when pre-procedure mid-stream urine culture is sterile.

Rigid Mini-Thoracoscopy Versus Semirigid Thoracoscopy in Undiagnosed Exudative Pleural Effusion: The MINT Randomized Controlled Trial.

BACKGROUND: There is debate regarding the ideal instrument for medical thoracoscopy. The authors compared rigid mini-thoracoscopy with semirigid thoracoscopy for thoracoscopic pleural biopsy. METHODS: Consecutive subjects with undiagnosed exudative pleural effusion were randomized (1:1 ratio) to mini-thoracoscopy or semirigid thoracoscopy groups. The primary objective was a comparison of the diagnostic yield of pleural biopsy. Key secondary outcomes were the comparison of sedative/analgesic dose, operator-rated and patient-rated pain on visual analog scale (VAS), operator-rated overall procedural satisfaction (VAS), pleural biopsy size, and complications between the groups. RESULTS: Of the 88 screened subjects, 73 were randomized: 36 to mini-thoracoscopy and 37 to semirigid thoracoscopy. Diagnostic yield of pleural biopsy in the mini-thoracoscopy (69.4%) and semirigid thoracoscopy groups (81.1%) was similar on intention-to-treat analysis (P=0.25). Although the operator-rated overall procedure satisfaction scores were similar between groups (P=0.87), operator-rated pain [VAS (mean±SD), 43.5±16.7 vs. 31.7±15.8; P<0.001] and patient-rated pain (VAS, 41.9±17.3 vs. 32.1±16.5; P=0.02) scores were greater in the mini-thoracoscopy group. Mean dose of fentanyl and midazolam received was similar between the 2 groups (P=0.28 and 0.68, respectively). Biopsy size was larger in the mini-thoracoscopy group (16.1±4.5 vs. 8.3±2.9 mm; P<0.001). Three minor complications occurred in the mini-thoracoscopy group and 6 in the semirigid thoracoscopy group (P=0.11). There were no serious adverse events or procedure-related mortality. CONCLUSION: Diagnostic yield of rigid mini-thoracoscopy is not superior to semirigid thoracoscopy. Use of semirigid thoracoscope may provide greater patient comfort.

Early posttraumatic changes in coagulation and fibrinolysis systems in isolated severe traumatic brain injury patients and its influence on immediate outcome.

OBJECTIVE/BACKGROUND: Early coagulopathy in isolated severe traumatic brain injury occurs despite the lack of severe bleeding, shock, and fluid administration. We aimed to correlate coagulation activation/inhibition, thrombin generation and fibrinolysis with the development of acute trauma induced coagulopathy (TIC) and its effects on early mortality in isolated severe traumatic brain injury (iSTBI) patients. METHODS: A prospective screening of iSTBI patients was done for two years. History of anticoagulants, liver disease, hypotension, extracranial injuries, transfusion, brain death were excluded. TIC was defined as international normalized ratio (INR) ≥ 1.27 and/or prothrombin time (PT) ≥ 16.7 seconds and/or activated partial thromboplastin Time (aPTT) ≥ 28.8 seconds on admission following iSTBI. Analysis of tissue factor (TF), tissue factor pathway inhibitor (TFPI), protein C (PC), protein S (PS), thrombin/antithrombin complex (TAT), soluble fibrin monomer (sFM), tissue plasminogen activator (tPA) and plasminogen activator inhibitor-1 (PAI-1) was done. Cases were categorized as presence or absence of TIC and 20 healthy controls participants were included. RESULTS: A total of 120 cases met the inclusion criteria, aged 35.7 ±â€¯12.12 years, 96% males. TIC was identified in 50 (41.6%). TIC occurred independently of age, sex, Glasgow coma scale (GCS) but was associated with acidosis (60%; p = .01). Following iSTBI significant decline was seen in coagulation activation. Thrombin generation and fibrinolysis were markedly increased. TF, TFPI, PC and PS were low in TIC compared with control. Significant depletion of PS was seen in TIC versus No-TIC. TBI patients with depleted PS had an odds ratio (OR) of 7.10 (1.61-31.2) for TIC. Receiver operating characteristic curve (ROC) analysis depicted area under the curve (AUC) of 0.73 (95% confidence interval [CI] 0.63-0.84) with a cut-off of ≥74 of PS (specificity 63.9%, sensitivity 72.7%). In-hospital mortality was higher in TIC group (44%) compared with no-TIC (20%) with OR of 4.73 (95% CI 1.68-13.3) and hazard ratio [HR] of 2.8 (95 % CI 1.2-6.4). CONCLUSION: Incidence of TIC in iSTBI is 41.6%, with 4.7 times odds for mortality. Traumatic brain injury causes enhanced coagulation activation, inadequate inhibition, exacerbation of thrombin generation, and subsequent increased fibrinolysis. ROC curve analysis revealed a cut-off of PS ≤ 74 with specificity 63.8%, sensitivity 72.7% for development of TIC.

Comparative efficacy of a 12 week yoga-based lifestyle intervention and dietary intervention on adipokines, inflammation, and oxidative stress in adults with metabolic syndrome: a randomized controlled trial.

The present randomized controlled trial (RCT) evaluated the comparative efficacy of 12 week yoga-based lifestyle intervention (YBLI) and dietary intervention (DI) alone on adipokines, inflammation, and oxidative stress in Indian adults with metabolic syndrome (Met S). A parallel, two arm, RCT was conducted in Integral Health Clinic (IHC), All India Institute of Medical Sciences, India from 2012 to 2014. IHC is an outpatient facility conducting YBLI programs for prevention and management of chronic diseases. Two hundred sixty men and women (20-45 years) visiting the outpatient department of a tertiary care hospital were diagnosed with Met S and randomized 1:1 to receive 12 week YBLI (n = 130) or DI (n = 130). Primary outcomes were change in plasma levels of adipokines (leptin, adiponectin, and leptin:adiponectin ratio), markers of inflammation (tumor necrosis factor [TNF]-α, interleukin [IL]-6), markers of oxidative stress (thiobarbituric acid reactive substances [TBARS], 8-hydroxy-2'-deoxyguanosine [8-OHdG], and superoxide dismutase [SOD]) measured at baseline, 2 weeks, and 12 weeks. YBLI group showed a significant decrease in leptin, leptin:adiponectin ratio, IL-6, 8-OHdG, and TBARS levels, whereas there was a significant increase in adiponectin and SOD levels. No significant changes were noticed in DI alone group. YBLI showed significantly greater reduction in TBARS levels than in DI group, suggestive of reduced oxidative stress in adults with Met S. A 12 week YBLI had a positive impact on oxidative stress versus DI alone in adults with Met S.

Impact of nicotine replacement therapy as an adjunct to anti-tuberculosis treatment and behaviour change counselling in newly diagnosed pulmonary tuberculosis patients: an open-label, randomised controlled trial.

We evaluated the impact of intensive smoking cessation activities as an adjunct to anti-tuberculosis treatment on patient-related treatment outcomes. In this open-label, randomised controlled trial, self-reporting smokers with pulmonary tuberculosis who initiated standard anti-tuberculosis treatment were randomised to either nicotine replacement therapy and behaviour change counselling (n = 400) or counselling alone (n = 400) provided at baseline and two follow-up visits. The primary outcomes were change in TBscore at 24-weeks and culture conversion at 8-weeks. Biochemical smoking quit rates defined as serum cotinine levels <10 ng/mL and/or exhaled carbon monoxide levels <6 ppm (47·8% vs 32·4%, p-value =< 0·001) and self-reported quit rates (69.3% vs 38·7%, p-value =< 0·001) were significantly higher in the intervention arm at 24-weeks. Though the TBscores at 24 weeks (95% CI) were lower in the intervention arm [2·07 (1·98, 2·17) versus 2.12 (2·02, 2·21)], the difference was not clinically meaningful. Patients in the control arm required treatment extension more often than intervention arm (6·4% vs 2·6%, p-value = 0·02). Combining nicotine replacement therapy with behaviour change counselling resulted in significantly higher quit rates and lower cotinine levels, however, impact on patient-related (TBscore) or microbiological outcomes (culture conversion) were not seen.

Prevalence of dental caries and periodontal disease in a rural area of Faridabad District, Haryana, India.

An oral health survey was conducted in 829 individuals in different age groups in Ballabhgarh, Haryana, India, to estimate the prevalence of Dental caries and Periodontal diseases. A survey tool was modified from WHO's STEPwise approach to surveillance and Oral Health Assessment form 2013 from recently released WHO Oral Health Survey: Basic Methods (5th Edition) keeping in mind the South East Asian region. Out of 28 villages, six villages were randomly selected. A random list of study participants (Age-sex specific) was generated from the pooled list of these 6 villages. Local health workes helped in inviting the specific subjects to one centralized location within each village/ locality. The subjects were examined by trained dental surgeons and recordings were done by trained assistants. The prevalence of dental caries in 5-7 year, 12-15 year, 35-44 year and 65-74 year was 33.2%, 31.3%, 64.9% and 50.1% respectively. The prevalence of Periodontal Disease in 35-44 year and 65-74 year found to be 65.2% and 90.4% respectively. Only 37 participants had mucosal lesions, of which leukoplakia and tobacco pouch keratosis was seen in majority. Using the adopted tool, the prevalence of dental caries was found to be highest in 35-44 year (64.9%) age group and the prevalence of periodontal disease was found to be high in 35-44 year (65.2%) age group and highest in 65-74 year (90.4%) age group. Oral health promotion efforts are required to prevent oro-dental diseases in the studied population.