Bioavailability of a novel sustained-release pellet formulation of 5-flucytosine in healthy-fed participants for use in patients with cryptococcal meningitis.

Cryptococcal meningoencephalitis (CM) is an opportunistic fungal infection and a major cause of death among people living with human immunodeficiency virus in sub-Saharan Africa. 5-flucytosine (5-FC) is a unique, brain-permeable antifungal agent used to reduce mortality from CM and to prevent disease in individuals carrying cryptococcal antigen. 5-FC has a short plasma half-life, requiring 6-hourly oral dosing with an immediate-release (IR) formulation, a significant challenge in hospital and outpatient settings, risking a lack of compliance.

Bioavailability of three novel oral, sustained-release pellets, relative to an immediate-release tablet containing 500 mg flucytosine: A randomized, open-label, crossover study in healthy volunteers.

The opportunistic fungal infection cryptococcal meningoencephalitis is a major cause of death among people living with HIV in sub-Saharan Africa. We report pharmacokinetic (PK) and safety data from a randomized, four-period crossover phase I trial of three sustained-release (SR) oral pellet formulations of 5-flucytosine conducted in South Africa. These formulations were developed to require less frequent administration, to provide a convenient alternative to the current immediate release (IR) formulation, A.

A constructive non-local means algorithm for low-dose computed tomography denoising with morphological residual processing.

Low-dose computed tomography (LDCT) has attracted significant attention in the domain of medical imaging due to the inherent risks of normal-dose computed tomography (NDCT) based X-ray radiations to patients. However, reducing radiation dose in CT imaging produces noise and artifacts that degrade image quality and subsequently hinders medical disease diagnostic performance. In order to address these problems, this research article presents a competent low-dose computed tomography image denoising algorithm based on a constructive non-local means algorithm with morphological residual processing to achieve the task of removing noise from the LDCT images.

Techno-economic optimization and No emission reduction through steam injection in gas turbine combustion chamber for waste heat recovery and water production.

Considering the persistent human need for electricity and fresh water, cogeneration systems based on the production of these two products have attracted the attention of researchers. This study investigates a cogeneration system of electricity and fresh water based on gas turbine (GT) as the prime mover. The wasted energy of the GT exhaust gases is absorbed by a heat recovery steam generator (HRSG) and supplies the superheat steam required by the steam turbine (ST).

Machine learning-based automatic detection of novel coronavirus (COVID-19) disease.

The pandemic was announced by the world health organization coronavirus (COVID-19) universal health dilemma. Any scientific appliance which contributes expeditious detection of coronavirus with a huge recognition rate may be excessively fruitful to doctors. In this environment, innovative automation like deep learning, machine learning, image processing and medical image like chest radiography (CXR), computed tomography (CT) has been refined promising solution contrary to COVID-19.

AmBisome Monotherapy and Combination AmBisome-Miltefosine Therapy for the Treatment of Visceral Leishmaniasis in Patients Coinfected With Human Immunodeficiency Virus in India: A Randomized Open-Label, Parallel-Arm, Phase 3 Trial.

Background: Visceral leishmaniasis (VL) in patients with human immunodeficiency virus (HIV) presents an increasingly important patient cohort in areas where both infections are endemic. Evidence for treatment is sparce, with no high-quality studies from the Indian subcontinent.

Methods: This is a randomized, open-label, parallel-arm, phase 3 trial conducted within a single hospital in Patna, India.

Efficacy and safety of ravidasvir plus sofosbuvir in patients with chronic hepatitis C infection without cirrhosis or with compensated cirrhosis (STORM-C-1): interim analysis of a two-stage, open-label, multicentre, single arm, phase 2/3 trial.

Background: In low-income and middle-income countries, affordable direct-acting antivirals are urgently needed to treat hepatitis C virus (HCV) infection. The combination of ravidasvir, a pangenotypic non-structural protein 5A (NS5A) inhibitor, and sofosbuvir has shown efficacy and safety in patients with chronic HCV genotype 4 infection. STORM-C-1 trial aimed to assess the efficacy and safety of ravidasvir plus sofosbuvir in a diverse population of adults chronically infected with HCV.

Similar biologics in India: A story of access or potential for compromise?

Biosimilars or similar biotherapeutic products are the biological products approved by regulatory agencies based on the demonstration of similarity in quality, safety and efficacy with reference biologics (or original biologics). Though biosimilars could be considered as interchangeable therapeutic alternatives over original biologics, there are concerns regarding their similarity in effectiveness and safety with reference product along with the level of evidence of similarity required for approval. The biosimilars, particularly, monoclonal antibodies that are developed based on the complex manufacturing processes, require stringent comparative evaluations.

Reflection of Epidemiological Impact on Burden of Injury in Tertiary Care Centre, Pre-COVID and COVID Era: "Lockdown, a Good Fortune for Saving Life and Limb".

Road traffic injuries continue to be a major public health concern and are a leading cause of death and injury across the world. Road transport remains the most favoured mode of transport for both freight and passenger movement in India. As per the World Health Organization, approximately 1.

Long-term incidence of relapse and post-kala-azar dermal leishmaniasis after three different visceral leishmaniasis treatment regimens in Bihar, India.

Background: Few prospective data exist on incidence of post kala-azar dermal leishmaniasis (PKDL) and visceral leishmaniasis (VL) relapse after different treatment regimens.

Methodology/principal Findings: A Phase IV trial included 1761 VL patients treated between 2012-2014 with single dose AmBisome (SDA; N = 891), miltefosine-paromomycin (Milt-PM; n = 512), or AmBisome-miltefosine (AmB-Milt; n = 358). Follow-up for PKDL and VL relapse was scheduled for 6, 12 and 24 months after treatment, lasting until 2017.

Field effectiveness of new visceral leishmaniasis regimens after 1 year following treatment within public health facilities in Bihar, India.

Background: An earlier open label, prospective, non-randomized, non-comparative, multi-centric study conducted within public health facilities in Bihar, India (CTRI/2012/08/002891) measured the field effectiveness of three new treatment regimens for visceral leishmaniasis (VL): single dose AmBisome (SDA), and combination therapies of AmBisome and miltefosine (AmB+Milt) and miltefosine and paromomycin (Milt+PM) up to 6 months follow-up. The National Vector Borne Disease Control Program (NVBDCP) recommended an extended follow up at 12 months post-treatment of the original study cohort to quantify late relapses.

Methods: The 1,761 patients enrolled in the original study with the three new regimens were contacted and traced between 10 and 36 months following completion of treatment to determine their health status and any occurrence of VL relapse.

High-power, low-flow, short-ablation duration-the key to avoid collateral injury?

Background: A common approach to ablating along the posterior wall of the left atrium in atrial fibrillation ablation is to use low power with longer duration for durable lesions and reducing thermal injury. We hypothesize that similar lesions can be safely obtained at high power with low open-irrigation flow and low duration.

Methods: Twenty-two porcine ventricles were placed in a tissue bath with circulating 0.

Field safety and effectiveness of new visceral leishmaniasis treatment regimens within public health facilities in Bihar, India.

Background: In 2010, WHO recommended the use of new short-course treatment regimens in kala-azar elimination efforts for the Indian subcontinent. Although phase 3 studies have shown excellent results, there remains a lack of evidence on a wider treatment population and the safety and effectiveness of these regimens under field conditions.

Methods: This was an open label, prospective, non-randomized, non-comparative, multi-centric trial conducted within public health facilities in two highly endemic districts and a specialist referral centre in Bihar, India.

Recent Development of Visceral Leishmaniasis Treatments: Successes, Pitfalls, and Perspectives.

Research in visceral leishmaniasis in the last decade has been focused on how better to use the existing medicines as monotherapy or in combination. Systematic research by geographical regions has shown that a universal treatment is far from today's reality. Substantial progress has been made in the elimination of kala-azar in South Asia, with a clear strategy on first- and second-line therapy options of single-dose liposomal amphotericin B and a combination of paromomycin and miltefosine, respectively, among other interventions.

Accreditation in India: Pathways and Mechanisms.

Continuing medical education (CME) is a valuable mechanism to update physicians' knowledge with ever-increasing plethora of contemporary advances within medical fraternity. Over time, scope of CME has seen change from simple clinical updates to comprehensive continuing professional development (CPD), which is accomplished with help of accredited CME programmes. The Medical Council of India, in 2011, made a mandatory resolution for doctors to attend minimum of 30 hours of CME/5 years to ensure recertification.

Preferences and attitudes of physicians in India towards continuing medical education.

: Physicians in India display an enthusiasm for continuing medical education (CME), however a proper system for facilitation and organisation of CME activities is yet to evolve in the country. s: A questionnaire-based survey was conducted among 751 physicians from eight medical specialties across India and the data retrieved was analysed at individual physician and collective specialty-specific levels. : The surveyed physicians considered case presentations (73%), live speaker programmes (70%) and round-table meetings/focus group meetings (70%) as the most effective CME activities.

Prevalence of drug-resistant pulmonary tuberculosis in India: systematic review and meta-analysis.

Background: Drug-resistant pulmonary tuberculosis (DR-TB) is a significant public health issue that considerably deters the ongoing TB control efforts in India. The purpose of this review was to investigate the prevalence of DR-TB and understand the regional variation in resistance pattern across India from 1995 to 2015, based on a large body of published epidemiological studies.

Methods: A systematic review of published studies reporting prevalence of DR-TB from biomedical databases (PubMed and IndMed) was conducted.

Impact of atrial fibrillation on outcomes with motor vehicle accidents.

Background: We examined the effect of AF a commonly encountered arrhythmia with significant morbidity on mortality following a motor vehicle accident (MVA) related hospitalization.

Methods: The Nationwide Inpatient Sample (NIS) was queried to identify patients with AF (ICD-9 CM 427.31) and MVA (ICD-9 CM E810.

Tuberculosis and biologics in rheumatology: A special situation.

India has a huge patient burden of rheumatic diseases (RDs) including rheumatoid arthritis. The use of biologics has transformed the treatment paradigm for RD; however, biologic treatment-related infections (especially tuberculosis [TB]) are an area of potential concern for TB-endemic nations like India. Anti-tumor necrosis factor (TNF) therapy impairs the physiological TNF-mediated signaling and may cause reactivation and dissemination of latent TB infection (LTBI).

Safety and efficacy of short course combination regimens with AmBisome, miltefosine and paromomycin for the treatment of visceral leishmaniasis (VL) in Bangladesh.

Background: AmBisome therapy for VL has an excellent efficacy and safety profile and has been adopted as a first-line regimen in Bangladesh. Second-line treatment options are limited and should preferably be given in short course combinations in order to prevent the development of resistant strains. Combination regimens including AmBisome, paromomycin and miltefosine have proved to be safe and effective in the treatment of VL in India.

Effects of Transendocardial Stem Cell Injection on Ventricular Proarrhythmia in Patients with Ischemic Cardiomyopathy: Results from the POSEIDON and TAC-HFT Trials.

Transendocardial stem cell injection in patients with ischemic cardiomyopathy (ICM) improves left ventricular function and structure but has ill-defined effects on ventricular arrhythmias. We hypothesized that mesenchymal stem cell (MSC) implantation is not proarrhythmic. Post hoc analyses were performed on ambulatory ECGs collected from the POSEIDON and TAC-HFT trials.

Contemporary utilization and safety outcomes of catheter ablation of atrial flutter in the United States: Analysis of 89,638 procedures.

Background: Atrial flutter (AFL) ablation has been increasingly offered as first-line therapy and safely performed over the last decades. However, limited data exist regarding current utilization and trends in adverse outcomes arising from this procedure.

Objective: The aim of our study was to examine the frequency of adverse events attributable to AFL ablation and influence of hospital volume on safety outcomes.

Phase I (first-in-man) prophylactic vaccine's clinical trials: Selecting a clinical trial site.

An appropriately equipped and staffed Phase I unit is critical for smooth conduct of a first-in-man clinical trial. The first-in-man prophylactic vaccine trial(s) requires basic infrastructure of clinical trial site, experienced and dedicated site staff and healthy adults as volunteers. The facility should have access to equipment, emergency services, laboratory, pharmacy and archiving.

Successful transradial retrieval of an embolized guidewire during transradial vascular access.

Transradial catheterization is associated with lower complication rates; however limited information is available regarding techniques to overcome unusual complications. We present a case of a 58-year-old male with suspected non-ST-elevated myocardial infarction who underwent transradial coronary angiography complicated by guidewire embolization into the radial artery and subsequent access loss. Successful retrieval of the embolized guidewire was achieved by re-accessing the same radial artery and the use of a 2 mm gooseneck microsnare.