Topical clobetasol for the treatment of toxic epidermal necrolysis: study protocol for a randomized controlled trial.

BackgroundToxic epidermal necrolysis (TEN) is a rare systemic allergic drug eruption with high patient mortality. Currently, no established treatments have been shown to be effective for TEN beyond supportive care. Prior studies of systemic corticosteroids have yielded conflicting data, with some showing a possible benefit and others reporting in increased mortality. However, topical steroids have shown promise for treatment of ocular sequelae of TEN, such as scarring and vision loss. We have designed a randomized controlled trial to evaluate topical clobetasol for treatment of the epidermal manifestations of TEN. In addition, we propose genetic studies to characterize the TEN transcriptome and alterations in cutaneous gene expression that might occur following topical steroid treatment.Methods/designThis split-body randomized, double-blind, placebo-controlled Phase IIa proof-of-concept trial will evaluate the safety and efficacy of once-daily topical clobetasol applied to the skin of patients with TEN. This multicenter trial will recruit a total of 15 patients between the ages of 12 and 85 from the University of California Davis Medical Center and Shriners Hospital for Children inpatient burn units. Designated treatment areas on opposite sides of the body will be treated with blinded clobetasol 0.05% ointment or control petrolatum ointment daily for 14 days. On day 3 of therapy, a biopsy will be taken from the treated area for genetic studies. The primary study aims will be to establish the safety of topical clobetasol treatment and determine the time to cessation of skin detachment for the control and clobetasol-treated areas. Secondary endpoints will evaluate efficacy using parameters such as time to 90% re-epithelialization and percentage of affected skin at 0, 3, 6, 9, 12 and 15 days. Genomic DNA and RNA will be obtained from biopsy samples, to characterize the TEN transcriptome and identify changes in gene expression after topical steroid treatment.DiscussionTopical steroids have shown promise for treating ocular complications of TEN, but to date have not been evaluated for cutaneous manifestations of the disease. This trial will investigate clinical and molecular outcomes of topical clobetasol application and hopefully provide insight into the disease pathophysiology.Trial registrationClinicalTrials.gov NCT02319616. https://clinicaltrials.gov/ct2/show/NCT02351037

A study to evaluate the clinical outcome of drug-eluting vs. bare-metal stents for acute coronary syndrome patients during commercial use in real setting

Background: This study compared clinical outcome of Drug Eluting Stents (DES) versus Bare Metal Stents (BMS) in coronary arteries in patients with Acute Coronary Syndromes.Methods: A retrospective, observational study was carried out in an inpatient setting of the private tertiary care hospital. Patients with >18 years, diagnosed for Acute Coronary Syndromes (ACS), required intervention in coronary artery with implantation of Drug Eluting Stents (DES) or Bare Metal Stents (BMS) were recruited in the study. The data had been collected from file or database of the hospital. All subjects were followed for major adverse cardiac event.Results: A total of 202 patients who underwent percutaneous coronary intervention (PCI) were enrolled into DES group (n=101) and BMS group (n=101). All patients were followed up at 1 month, 3 months, 6 months & 12 months for Major Adverse Cardiac Events (MACE). Clinical outcomes during 12 months were compared between DES group & BMS group. Overall MACE rates were reported non-significantly high in BMS group patients (14.85%) compare to DES group patients (8.91%) (p=0.458). However, DES group had lower rates of death (0.99% vs 1.98%, p=0.57), rate of MI (3.96% vs 4.95% p=0.73), rate of revascularization (1.98% vs 3.96% p=0.42) & rate of sub acute thrombosis (1.98% vs 3.96% p=0.42) and higher rate of bleeding (1.98% vs 0.99% p=0.57) compare to cohort-II.Conclusions: The use of DES in the setting of Acute Coronary Syndrome is associated with lower Major Adverse Cardiac Event (MACE) rate compared to BMS without compromising the overall safety over the course of one-year follow-up. The long-term safety of drug-eluting stents needs to be ascertained in large, randomized trials

A Study to Compare Major Adverse Cardiac Event in Patient Undergoing PCI with Drug Eluting Stents Vs Bare Metal Stents

This study compared Major Adverse Cardiac Event in patient with Acute Coronary Syndromes undergoing PCI with Drug Eluting Stents Vs Bare Metal Stents. A retrospective, observational study was carried out in an inpatient setting of the private tertiary care hospital. Patients with >18 years, diagnosed for Acute Coronary Syndromes (ACS), required intervention in coronary artery with implantation of Drug Eluting Stents (DES) or Bare Metal Stents (BMS) were recruited in the study. The data had been collected from file or database of the hospital. All subjects were followed for major adverse cardiac event. Result. A total of 202 patients who underwent percutaneous coronary intervention (PCI) were enrolled into DES group (N=101) and BMS group (N=101).  All patients were followed up at 1 month, 3 months, 6 months & 12 months for Major Adverse Cardiac Events (MACE). Clinical outcomes during 12 months were compared between DES group & BMS group. There was no significant difference in baseline parameters including demographic, risk factors of ACS, diagnosis, angiographic parameters between both groups. Overall MACE rates were reported non-significantly high in BMS group patients (14.85%) compare to DES group patients (8.91%) (P=0.458). However, DES group had lower rates of death (0.99% vs 1.98%, P=0.57), rate of MI (3.96% vs 4.95% P=0.73), rate of revascularization (1.98% vs 3.96% p=0.42) & rate of sub acute thrombosis (1.98% vs 3.96% P=0.42) and higher rate of bleeding (1.98% vs 0.99% p=0.57) compare to cohort-II. Conclusion. The use of DES in the setting of Acute Coronary Syndrome is associated with lower Major Adverse Cardiac Event (MACE) rate compared to BMS without compromising the overall safety over the course of one-year follow-up. The long-term safety of drug-eluting stents needs to be ascertained in large, randomized trials.DOI: http://dx.doi.org/10.11591/ijphs.v1i2.125

Broadband study of blazar 1ES 1959+650 during flaring state in 2016

Aim : The nearby TeV blazar 1ES 1959+650 (z=0.047) was reported to be in flaring state during June - July 2016 by Fermi-LAT, FACT, MAGIC and VERITAS collaborations. We studied the spectral energy distributions (SEDs) in different states of the flare during MJD 57530 - 57589 using simultaneous multiwaveband data to understand the possible broadband emission scenario during the flare. Methods : The UV/optical and X-ray data from UVOT and XRT respectively on board Swift and high energy $\gamma$-ray data from Fermi-LAT are used to generate multiwaveband lightcurves as well as to obtain high flux states and quiescent state SEDs. The correlation and lag between different energy bands is quantified using discrete correlation function. The synchrotron self Compton (SSC) model was used to reproduce the observed SEDs during flaring and quiescent states of the source. Results : A decent correlation is seen between X-ray and high energy $\gamma$-ray fluxes. The spectral hardening with increase in the flux is seen in X-ray band. The powerlaw index vs flux plot in $\gamma$-ray band indicates the different emission regions for 0.1 - 3 GeV and 3-300 GeV energy photons. Two zone SSC model satisfactorily fits the observed broadband SEDs. The inner zone is mainly responsible for producing synchrotron peak and high energy $\gamma$-ray part of the SED in all states. The second zone is mainly required to produce less variable optical/UV and low energy $\gamma$-ray emission. Conclusions : Conventional single zone SSC model does not satisfactorily explain broadband emission during observation period considered. There is an indication of two emission zones in the jet which are responsible for producing broadband emission from optical to high energy $\gamma$-rays.Comment: 11 pages, 12 figures, Accepted in A&

Improving the Isotretinoin Photostability by Incorporating in Microemulsion Matrix

The present paper demonstrates the increased photostability of isotretinoin when loaded in microemulsion. The photodegradation of isotretinoin, in methanol and microemulsion formulation was studied under direct sun light. The photodegradation process was monitored by UV spectrophotometry. In methanol solution, isotretinoin undergoes complete photodegradation just within a few minutes of light exposure. Isotretinoin incorporated in microemulsion formulation showed an increased stability in comparison to the methanol solutions. In particular for isotretinoin, a residual concentration of 75% was still present after a light irradiance versus a residual value of just 16% measured at the same time in methanol solution. Further, degradation kinetic parameters of isotretinoin-loaded microemulsion formulation were demonstrated increase isotretinoin half-life about five-times in comparison with a methanol solution under a direct sun light

Comparative Phytonutrients Analysis and Proximate Constituents of few Accessions of Nigerian and Indian Eggplant (Solanum species)

Vegetable plants contain appreciable amount of bioactive components that may provide desirable well-being merits beyond primary nutrition. It also provide major role in preventing numerous chronic diseases. Therefore, this study compared the morphological, nutritional and phytonutrients parameters of some accessions of Nigerian and Indian Eggplants in a Completely Randomized design model. The Nigerian accessions are namely: NG/MR/MAY/09/007; NGB01309 and NHGB/09/136 collected from NACGRAB, Ibadan, Nigeria while the Indian accessions are NISHA improved and PINK collected from Authorized Agency, India. The results revealed a significant difference in the germination percentage with Indian species recorded between 80 and 90% as against between 50 and 70% noted for Nigerian species. Average plant height at 90 days for India samples was 33cm, 30cm for Nisha and Pink respectively while Nigerian samples was significantly high in height (48.3cm, 21cm and 36.3cm for NG/MR/MAY/09/007, NGB01309 and NHGB/09/136 respectively). With the exception of NGB01309 other Nigerians samples were superior (P<0.05) to the Indian sample. The phytochemicals of the leaves and fruits (Flavonoid, Cardiac glycosides, Alkaloids, Saponins, Tannins and Phytates) reported herein was greater in all Nigerian samples. Nutritionally, the Indian samples were superior in all the parameters (% Starch, Protein and Crude fibre) examined. The availability of more phytonutrients in Nigerian accession relates to more and better prevention of cardiovascular, stroke, Alzheimer and cancer diseases as well as ageing. In conclusion the accessions showed their potentials as a good source for use as nutraceuticals so as to promote general health, control symptoms and check malignant diseases. Keywords: Solanum species, phytochemicals, morphology, nutritional valu

A Study to Compare Major Adverse Cardiac Event in Patient Undergoing PCI with Drug Eluting Stents Vs Bare Metal Stents

This study compared Major Adverse Cardiac Event in patient with Acute Coronary Syndromes undergoing PCI with Drug Eluting Stents Vs Bare Metal Stents. A retrospective, observational study was carried out in an inpatient setting of the private tertiary care hospital. Patients with >18 years, diagnosed for Acute Coronary Syndromes (ACS), required intervention in coronary artery with implantation of Drug Eluting Stents (DES) or Bare Metal Stents (BMS) were recruited in the study. The data had been collected from file or database of the hospital. All subjects were followed for major adverse cardiac event. Result. A total of 202 patients who underwent percutaneous coronary intervention (PCI) were enrolled into DES group (N=101) and BMS group (N=101). All patients were followed up at 1 month, 3 months, 6 months & 12 months for Major Adverse Cardiac Events (MACE). Clinical outcomes during 12 months were compared between DES group & BMS group. There was no significant difference in baseline parameters including demographic, risk factors of ACS, diagnosis, angiographic parameters between both groups. Overall MACE rates were reported non-significantly high in BMS group patients (14.85%) compare to DES group patients (8.91%) (P=0.458). However, DES group had lower rates of death (0.99% vs 1.98%, P=0.57), rate of MI (3.96% vs 4.95% P=0.73), rate of revascularization (1.98% vs 3.96% p=0.42) & rate of sub acute thrombosis (1.98% vs 3.96% P=0.42) and higher rate of bleeding (1.98% vs 0.99% p=0.57) compare to cohort-II. Conclusion. The use of DES in the setting of Acute Coronary Syndrome is associated with lower Major Adverse Cardiac Event (MACE) rate compared to BMS without compromising the overall safety over the course of one-year follow-up. The long-term safety of drug-eluting stents needs to be ascertained in large, randomized trials

Growth of mango (Mangifera indica L.) rootstocks as influenced by pre-sowing treatments

An experiment was carried out at Navsari Agricultural University, Navsari during 2014 to evaluate the effect of pre-sowing treatments on survival percentage and growth of mango rootstocks. Mango stones were soaked in aqueous solutions of GA3 (100 and 200 ppm), Beejamruth (2 % and 3 %) and Thiourea (1 % and 2 %) for 12 and 24 hours. The trial was evaluated in Completely Randomized Design based on factorial concept and the treatments were replicated thrice. Imposition of treatments led to significant differences at 5 % level of significance for all parameters chosen in this study. Mango stones when treated with Thiourea at 1 % had the maximum shoot length (49.93 cm), root length (34.38 cm), shoot dry weight (21.08 g) and total dry weight (26.36 g). The highest number of lateral roots (10.90) and survival percentage (64.17) was observed in mango stones dipped in 100 ppm GA3. Between the two soaking duration, soaking mango stones for 24 hours recorded higher values for shoot length (45.03 cm), root length (32.79 cm), number of lateral roots (9.83), survival percentage (62.72), shoot root fresh weight ratio (4.30), shoot dry weight (21.33 g), total dry weight (26.28 g) and shoot root dry weight ratio (4.32). Thus, survival percentage and growth of mango rootstocks can be substantially improved by soaking mango stones in aqueous solutions of 100 ppm GA3 or Thiourea at 1 % for 24 hours before sowing

Characteristics of Fatal Cases of Pandemic Influenza A (H1N1) from September 2009 to January 2010 in Saurashtra Region, India

Background: India reported first case of 2009 pandemic influenza A (H1N1) virus infection in May, 2009 and Saurashtra region in August, 2009. We describe the characteristics of fatal cases of 2009 influenza A (H1N1) infection reported in Saurashtra region. Methods: From September, 2009 to January, 2010, we observed 71 fatal cases that were infected with 2009 influenza A (H1N1) virus and admitted in different hospitals in Rajkot city. Real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) testing was used to confirm infection; the clinico-epidemiological features were observed and documented. Results: Median age of the deceased (71) was 29 years, and 57.7% were females. Median time observed was 5 days from onset of illness to diagnosis of influenza A (H1N1), and 57.7% were referred from general practitioner (OR=0.42, CI=0.24-0.74). Median hospital stay reported was 3 days. All admitted patients received oseltamivir, but only 16.9% received it within 2 days of onset of illness. The most common symptoms were cough (97.2%), fever (93%), sore throat and shortness of breath. Co-morbid conditions were present in almost half of the patients who ultimately died, the most common of which was pregnancy (OR=0.15, CI=0.04-0.52). Radiological pneumonia was reported in 98% patients. Conclusion: Residing in urban area, delayed referral from general practitioner, presence of co-existing condition, especially pregnancy was responsible for mortality among influenza A (H1N1) infected positive