Evaluating performance of a near-infrared-spectroscopy-based and machine-learning-powered bio-optical sensitivity parameters in identifying intracranial hemorrhages in TBI across different age-groups.

PRIMARY OBJECTIVE: To evaluate the accuracy of an innovative machine-learning-powered near-infrared spectroscopy (mNIRS)-based bio-optical sensitivity parameters, namely specific tissue optical index (STOI) and intracranial tissue optical index (ITOI) for effective triaging of patients with suspected traumatic brain injury (TBI) across different age-groups to facilitate timely intervention and curtail the silent epidemic. RESEARCH DESIGN: Prospective, observational, double-blinded, cross-sectional single-center. METHODS: A total of 240 subjects suspected with TBI and recommended for head CT scan were enrolled. Findings of CT were compared with the bio-optical sensitivity parameters (STOI+ITOI) generated by the mNIRS system to detect intracranial hemorrhages (ICHs). STATISTICAL SOFTWARE USED: SPSS (IBM VERSION 21.0) RESULTS: Bio-optical sensitivity parameters (STOI+ITOI) analysis of 1288 scanned lobes showed high specificity of 97% (CI 95-98%), sensitivity of 96% (CI 92-99%), and accuracy of 97% (CI 96-98%) across all ages, maintaining robust performance for detecting subdural, epidural, subarachnoid hemorrhages, and contusions. Also, the reliability in the diagnosis of ICH was evidenced by Youden's index of 0.93 and positive and negative likelihood ratios of 29.13 and 0.04, respectively. CONCLUSION: The mNIRS-based STOI+ITOI proves to be an effective triage tool for TBI, exhibiting superior diagnostic performance across all age-groups.

Biochemical Composition of Pulp and Seed of Wild Jack (Artocarpus hirsutus Lam.) Fruit.

Wild jack (Artocarpus hirsutus Lam.) is an endemic perennial tree of Western Ghats of India. Wild jack, a timber purpose tree, is distributed in several Kaan community forests. Although local people consume unripe as well as fully ripe fruits and roasted seeds, wild jack is unrecognized as a fruit tree. It remains almost undocumented with respect to nutritional value in terms of biochemical composition. We carried out biochemical profiling of ripe fruits and seeds of wild jack. Every 100 g fruit pulp was composed of 12 g total soluble sugars, 16.7 g total starch, 441 µg total carotenoids (beta carotene equivalent) and 8.1 mg ascorbic acid, 0.4 mg GAE total phenol and showed total cupric reducing antioxidant activity of 1.9 mg gallic acid equivalents (GAE). Every 100 g whole seed flour was composed of 6 g total soluble sugars, 6.6 g starch, 9.9 g total proteins, 3 mg GAE total phenol and 3.1 mg GAE total antioxidant capacity. Biochemical profiles of wild jackfruit and seeds were comparable with those of other Artocarpus fruits like jackfruit and bread fruit. Our findings suggest that wild jack deserves to be promoted as a minor fruit species of high nutritional importance and must be considered as a potential fruit crop species for further research.

Human factor engineering of point-of-care near infrared spectroscopy device for intracranial hemorrhage detection in Traumatic Brain Injury: A multi-center comparative study using a hybrid methodology.

OBJECTIVE: This study assessed machine learning powered Near-infrared spectroscopy based (mNIRS) device's usability and human factor ergonomics in four distinct healthcare provider groups. BACKGROUND: Traumatic Brain Injury (TBI) is a global concern with significant well-being implications. Timely intracranial hemorrhage (ICH) detection is crucial. mNIRS offers efficient non-invasive TBI screening. METHODS: Two device utilization stages involved operators (N = 21) and TBI-suspected subjects (n = 120). A hybrid approach used qualitative and quantitative methods, utilizing a 57-item survey and task completion time. RESULTS: All groups positively perceived user-interface, physical, cognitive, and organizational ergonomics. The device's ease of use, calibration, size, cognitive support, and integration gained appreciation. Training reduced task completion time from 16.5 to 13.2 s. CONCLUSION: mNIRS-based CEREBO® proves usable for TBI point-of-care assessment. Positive feedback from diverse healthcare groups validates design and cost-effectiveness alignment. A hybrid approach, training, and practice scans enhance usage and experience.

CEREBO®: A Portable Device for Non-invasive Detection of Intracranial Hematomas in Real Time.

Context: Brain injury has become a silent epidemic and has very low survival and recovery rates because of inaccurate triaging, especially in absence of symptoms. Therefore, a clinical assessment tool for quick onsite detection of intracranial hematoma is necessary. Aims: This study aims to assess the efficacy of the near infrared-based device CEREBO® for the non-invasive detection of intracranial hematomas in traumatic head injury patients. Settings and Design: Observational, prospective, cohort, single-center study. Methods and Materials: Forty-four patients recruited from the Department of Neurosurgery of Civil Hospital, Ahmedabad, between 3 and 85 years from June 2018 to March 2020 were examined by CEREBO® and computed tomography (CT) scan within 72 h post-injury or first onset of symptoms to measure the desired parameters. Statistical Analysis Used: SAS 9.4. Results: The device exhibited high sensitivity (94.87%) and specificity (76.19%) for unilateral hematomas with a positive predictive value (PPV) of 93.67% and a negative predictive value (NPV) of 80%. For bilateral hematomas, the device exhibited a sensitivity of 80%, specificity of 77.78%, PPV 83.33%, and NPV 73.68%. Conclusions: This study establishes the efficacy of CEREBO® to be used as a point-of-care medical screening device for detecting brain hematomas in patients who have had a head injury and is therefore recommended as an adjunct to CT scan. In the triaging or diagnosis phase, it allows for early treatment and thus helps to reduce the secondary injury resulting from the existing and delayed hematomas.

Advancing edema detection: Harnessing the power of machine learning and near infrared spectroscopy for cerebral and cerebellar edema assessment.

Edema, characterized by brain swelling, is a common response observed in various brain injuries. Timely detection of edema is crucial to mitigate the associated risks and improve patient care. This study evaluates the efficacy of CEREBO®, a non-invasive machine learning-powered near-infrared spectroscopy (mNIRS) based device, in detecting edema. The study was conducted on 234 participants with suspected head injuries who underwent simultaneous CEREBO® scans and CT head scans. The results of the study showed that CEREBO® effectively identified edematous lobes, achieving a sensitivity of 95.7%, specificity of 97%, and accuracy of 96.9% for cases with intracranial hemorrhage (ICH). Additionally, for cases without ICH, the device exhibited a sensitivity of 100%, specificity of 97.2%, and accuracy of 97.2%. Two cases were reported where CEREBO® failed to detect edematous ICH. The study highlights the potential of CEREBO® as a valuable tool for early detection of pre-symptomatic edema and ICH, enabling timely interventions and improved patient care. The findings support the reliability of near-infrared spectroscopy as a diagnostic modality for edema.

Study on Mixed Solvency Concept in Formulation Development of Aqueous Injection of Poorly Water Soluble Drug.

In the present investigation, mixed-solvency approach has been applied for the enhancement of aqueous solubility of a poorly water- soluble drug, zaltoprofen (selected as a model drug), by making blends (keeping total concentrations 40% w/v, constant) of selected water-soluble substances from among the hydrotropes (urea, sodium benzoate, sodium citrate, nicotinamide); water-soluble solids (PEG-4000, PEG-6000); and co-solvents (propylene glycol, glycerine, PEG-200, PEG-400, PEG-600). Aqueous solubility of drug in case of selected blends (12 blends) ranged from 9.091 ± 0.011 mg/ml-43.055 ± 0.14 mg/ml (as compared to the solubility in distilled water 0.072 ± 0.012 mg/ml). The enhancement in the solubility of drug in a mixed solvent containing 10% sodium citrate, 5% sodium benzoate and 25 % S cosolvent (25% S cosolvent contains PEG200, PEG 400, PEG600, Glycerine and Propylene glycol) was more than 600 fold. This proved a synergistic enhancement in solubility of a poorly water-soluble drug due to mixed cosolvent effect. Each solubilized product was characterized by ultraviolet and infrared techniques. Various properties of solution such as pH, viscosity, specific gravity and surface tension were studied. The developed formulation was studied for physical and chemical stability. This mixed solvency shall prove definitely a boon for pharmaceutical industries for the development of dosage form of poorly water soluble drugs.

Antifertility effect of chronically administered Tabernaemontana divaricata leaf extract on male rats.

OBJECTIVE: To investigate the antifertility effect of chronically administered Tabernaemontana divaricata (T. divaricata) leaf extract on male rats. METHODS: The effect of 50% ethanol extract of T. divaricata leaves on reproduction was studied on male rats. The study was divided into four groups of five animals each. The first groups (I) received vehicle alone to serve as control. The second, third and fourth groups (II, II and IV) of animals were administered the leaf extract daily at 50 mg/kg body weight, p.o.,100 mg/kg body weight, p.o., and 200 mg/kg body weight, p.o., respectively, for a period of 60 days. RESULTS: Significant decreases in the weight of testes, epididymis, seminal vesicle and ventral prostate were observed. A dose related reduction in the testicular sperm count, epididymal sperm count and motility, number of fertile male, ratio between delivered and inseminated females and numbers of pups were observed. The testis showed a clear correlation between the dose and severity of lesions of seminiferous epithelium. In general, the seminiferous tubules appear reduced in size with a frequently filled eosinophilic material. Spermatogenesis arrested at the secondary spermatocyte stage. Pachytene spermatocytes were undergoing degeneration. Disorganigation and sloughing of immature germ cell were visible. Leydinf cells were atrophied. No morphological changes were observed in Sertoli cells. Significant reduction in serum concentration of luteinizing hormone and testosterone were observed. No distinct change in serum FSH concentration was recorded. The final body weights of all groups were elevated markedly. No alterations were recorded in any hematologiocal parameters. CONCLUSION: It is concluded that the 50% ethanol extract of T. divaricata leaf produced dose related effect on male reproduction without altering general body metabolism.

Microemulsion drug delivery system: for bioavailability enhancement of ampelopsin.

Ampelopsin, one of the most common flavonoids, reported to possess numerous pharmacological activities and shows poor aqueous solubility. The purpose of this study was to enhance the dissolution rate and bioavailability of this drug by developing a novel delivery system that is microemulsion (ME) and to study the effect of microemulsion (ME) on the oral bioavailability of ampelopsin. Capmul MCM-based ME formulation with Cremophor EL as surfactant and Transcutol as cosurfactant was developed for oral delivery of ampelopsin. Optimised ME was evaluated for its transparency, viscosity, percentage assay and so forth. Solubilisation capacity of the ME system was also determined. The prepared ME was compared with the pure drug solution and commercially available tablet for in vitro drug release. The optimised ME formulation containing ampelopsin, Capmul MCM (5.5%), Cremophor EL (25%), Transcutol P (8.5%), and distilled water showed higher in vitro drug release, as compared to plain drug suspension and the suspension of commercially available tablet. These results demonstrate the potential use of ME for improving the bioavailability of poor water soluble compounds, such as ampelopsin.

Formulation and evaluation of aceclofenac mouth-dissolving tablet.

Aceclofenac has been shown to have potent analgesic and anti-inflammatory activities similar to indomethacin and diclofenac, and due to its preferential Cox-2 blockade, it has a better safety than conventional Non steroidal anti-inflammatory drug (NSAIDs) with respect to adverse effect on gastrointestinal and cardiovascular systems. Aceclofenac is superior from other NSAIDs as it has selectivity for Cox-2, a beneficial Cox inhibitor is well tolerated, has better Gastrointestinal (GI) tolerability and improved cardiovascular safety when compared with other selective Cox-2 inhibitor. To provide the patient with the most convenient mode of administration, there is need to develop a fast-disintegrating dosage form, particularly one that disintegrates and dissolves/disperses in saliva and can be administered without water, anywhere, any time. Such tablets are also called as "melt in mouth tablet." Direct compression, freeze drying, sublimation, spray drying, tablet molding, disintegrant addition, and use of sugar-based excipients are technologies available for mouth-dissolving tablet. Mouth-dissolving tablets of aceclofenac were prepared with two different techniques, wet granulation and direct compression, in which different formulations were prepared with varying concentration of excipients. These tablets were evaluated for their friability, hardness, wetting time, and disintegration time; the drug release profile was studied in buffer Phosphate buffered Saline (PBS) pH 7.4. Direct compression batch C3 gave far better dissolution than the wet granulation Batch F2, which released only 75.37% drug, and C3, which released 89.69% drug in 90 minutes.