A Snapshot of Biomarkers in Psoriasis.

A persistent long-standing, inflammatory skin condition that is brought on by a variety of factors is psoriasis. It is distinguished by itchy, scaly, reddish plaques, particularly on areas of the body that are frequently chafed, including the extensor sites of the limbs. Recent developments in molecular-targeted therapy that use biologics or small-molecule inhibitors can effectively cure even the worst psoriatic indications. The outstanding clinical outcomes of treatment help to clarify the disease's detrimental consequences on quality of life. Biomarkers that identify deep remission are essential for developing uniform treatment plans. Blood protein markers such as AMPs that are consistently quantifiable can be very helpful in routine clinical practice. The metabolic pathways involve biomarkers that can not only help diagnose psoriasis in a clinical setting but also indicate its severity based on the levels present in the body. Machine learning and AI have made a diagnosis of the expression of genes as biomarkers more accessible. In this article, biomarkers, as well as their key role in psoriasis, are discussed.

Effects of Mesenchymal Stem Cell-conditioned Media with Natural Immunomodulatory Agent Resveratrol on Type 1 Diabetes.

BACKGROUND: Type 1 diabetes mellitus (T1DM) is a condition marked by elevated blood sugar levels and primarily recognized by the destruction of beta cells caused by an autoimmune attack, which is a significant characteristic of T1DM. Recent studies have demonstrated the regenerative potential of conditioned medium therapy. In light of this, the current research sought to assess the impact of Mesenchymal Stem Cell conditioned media (CM) and CM with resveratrol (CM+ Resveratrol) on the management of T1DM in Swiss albino mice. By leveraging and modifying existing conditioned medium therapy, this study aims to evaluate its effectiveness in treating T1DM. MATERIALS & METHODS: Diabetes was induced in animals using the diabetes-inducing agent streptozotocin (STZ). The animals were then divided into five groups: Normal control, Disease Control, Resveratrol, Condition Media, and CM + Resveratrol. Treatments were given to the animals accordingly. The study period was 28 days. During this time, the animals were monitored for foodwater intake twice a week, blood glucose levels, and body weight. At the conclusion of the 28-day study period, biochemical estimations were performed for serum insulin levels, C-peptide levels, anti-inflammatory cytokines levels and pro-inflammatory cytokines levels. Additionally, histopathology of the pancreas was performed. RESULTS: The test groups showed a significant decrease in blood glucose levels, an increase in Cpeptide levels, and a decrease in pro-inflammatory cytokine levels compared to the disease group. However, no statistically significant change within groups was observed in terms of serum insulin and anti-inflammatory cytokine levels. The improvement in diabetic symptoms, such as polyphagia, polydipsia, and weight loss, was observed in the treatment group, along with pancreatic regeneration, which indicated improved insulin secretion. CONCLUSION: In the current investigation, we concluded that CM and CM+ Resveratrol, as natural immunomodulators, have the capacity to regenerate injured pancreatic beta cells and have antidiabetic action, together with immunomodulating impact. Nonetheless, future studies on this therapy appear to be promising.

Use of Postpartum Hemorrhage Checklist during Vaginal Deliveries: A Quality Improvement Study.

OBJECTIVE: Postpartum hemorrhage (PPH) protocols improve patient safety and reduce utilization of blood products; however, few data exist on sustainability of PPH checklist use, how use affects care delivery, and variation of use among patient subgroups. This study aimed to (1) examine compliance with PPH checklist use during vaginal deliveries, (2) evaluate whether checklist use varied by patient and/or care team characteristics, and (3) evaluate whether checklist use was associated with increased use of recommended medications/interventions. STUDY DESIGN: This was a quality improvement study performed from April 2021 through June 2023. A multidisciplinary team developed a revised PPH checklist and used quality improvement methodology to increase checklist use following vaginal birth. Data were collected from medical records and clinician survey. Control charts were generated to track checklist use and evaluate special cause variation. Chi-square tests and logistic regression were used to evaluate variation in medications/interventions and across subgroups. RESULTS: During the study period, there were 342 cases of PPH at the time of vaginal birth. The checklist was used in 67% of PPH cases during the 20-month period after implementation in a setting where no checklist was previously being used. We found no statistically significant differences in checklist use by patient or health care team characteristics. Use of tranexamic acid, carboprost, and misoprostol were significantly associated with checklist use. CONCLUSION: This study demonstrated successful implementation of a checklist protocol where no checklist was previously being used, with sustained use in an average of 67% of PPH cases over 20 months. Checklist use was consistent across subgroups and was associated with higher use of interventions shown to lower blood loss. KEY POINTS: · Our study showed sustainability of PPH checklist use over a 20-month period.. · PPH checklist use was associated with increased use of interventions known to reduce blood loss.. · Checklist was used consistently across patient subgroups; may help address inequities in obstetric outcomes..

LGBTQIA+ Outness in Otolaryngology Residency Applications.

Lesbian, gay, bisexual, transgender, queer, intersex, and asexual/aromantic (LGBTQIA+) providers improve health outcomes of sexual and gender minority (SGM) patients, which demonstrates the importance of understanding the state of LGBTQIA+ representation at all levels of medical training. The U.S. does not systematically collect sexual orientation and gender identity (SOGI) data from applicants, trainees, and attending physicians, prompting us to wonder whether SGM representation in surgical fields, such as otolaryngology, is adequate. Personal statements submitted to an otolaryngology program from 2019 to 2021 were searched for LGBTQIA+ terms, and those containing LGBTQIA+ terms underwent full text review to determine whether applicants identified themselves as LGBTQIA+. Across these 2 application cycles, the sampled residency program received 928 applications. Only 2 applicants of 928 (0.2%) self-disclosed their LGBTQIA+ identities in their personal statements. These results signify a scarcity of SGM diversity in otolaryngology and warrant deeper exploration into factors preventing residency applicants from self-disclosure of LGBTQIA+ identities.

A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants.

A fully liquid hexavalent containing Diphtheria (D), Tetanus (T) toxoids, whole cell Pertussis (wP), Hepatitis B (Hep B), type 1, 2, 3 of inactivated poliovirus (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (DTwP-HepB-IPV-Hib vaccine, HEXASIIL®) was tested for lot-to-lot consistency and non-inferiority against licensed DTwP-HepB-Hib + IPV in an open label, randomized Phase II/III study. In Phase III part, healthy infants received DTwP-HepB-IPV-Hib or DTwP-HepB-Hib + IPV vaccines at 6, 10 and 14 weeks of age. Blood samples were collected prior to the first dose and 28 days, post dose 3. Non inferiority versus DTwP-HepB-Hib + IPV was demonstrated with 95% CIs for the treatment difference for seroprotection/seroconversion rates. For DTwP-HepB-IPV-Hib lots, limits of 95% CI for post-vaccination geometric mean concentration ratios were within equivalence limits (0.5 and 2). Vaccine was well-tolerated and no safety concerns observed.Clinical Trial Registration - CTRI/2019/11/022052.

Global MEG Resting State Functional Connectivity in Children with Autism and Sensory Processing Dysfunction.

Sensory processing dysfunction not only affects most individuals with autism spectrum disorder (ASD), but at least 5% of children without ASD also experience dysfunctional sensory processing. Our understanding of the relationship between sensory dysfunction and resting state brain activity is still emerging. This study compared long-range resting state functional connectivity of neural oscillatory behavior in children aged 8-12 years with autism spectrum disorder (ASD; N=18), those with sensory processing dysfunction (SPD; N=18) who do not meet ASD criteria, and typically developing control participants (TDC; N=24) using magnetoencephalography (MEG). Functional connectivity analyses were performed in the alpha and beta frequency bands, which are known to be implicated in sensory information processing. Group differences in functional connectivity and associations between sensory abilities and functional connectivity were examined. Distinct patterns of functional connectivity differences between ASD and SPD groups were found only in the beta band, but not in the alpha band. In both alpha and beta bands, ASD and SPD cohorts differed from the TDC cohort. Somatosensory cortical beta-band functional connectivity was associated with tactile processing abilities, while higher-order auditory cortical alpha-band functional connectivity was associated with auditory processing abilities. These findings demonstrate distinct long-range neural synchrony alterations in SPD and ASD that are associated with sensory processing abilities. Neural synchrony measures could serve as potential sensitive biomarkers for ASD and SPD.

Curious Case of a Giant Retroperitoneal Cyst.

Adrenal cysts are uncommon fluid-filled masses that develop in the adrenal gland. Typically, they are non-functional, asymptomatic, and smaller than 10 cm in diameter when incidentally detected. However, the presence of giant adrenal cysts, exceeding 10 cm in diameter, creates a diagnostic challenge due to the difficulty in determining their origin. Surgical intervention is advised when the cyst surpasses 10 cm in diameter, produces symptoms, causes endocrine abnormalities, exhibits intracystic bleeding, or raises suspicion of malignancy. The preferred treatment approach involves adrenalectomy, performed either through open surgery or laparoscopy. In cases where the diagnosis is unequivocal, ultrasound-guided percutaneous drainage serves as an alternative. Here, we present an exceptional case of a massive retroperitoneal mass caused by a rare giant adrenal cyst.

High-resolution Inference of Multiplexed Anti-HIV Gene Editing using Single-Cell Targeted DNA Sequencing.

Gene therapy-based HIV cure strategies typically aim to excise the HIV provirus directly, or target host dependency factors (HDFs) that support viral persistence. Cure approaches will likely require simultaneous co-targeting of multiple sites within the HIV genome to prevent evolution of resistance, and/or co-targeting of multiple HDFs to fully render host cells refractory to HIV infection. Bulk cell-based methods do not enable inference of co-editing within individual viral or target cell genomes, and do not discriminate between monoallelic and biallelic gene disruption. Here, we describe a targeted single-cell DNA sequencing (scDNA-seq) platform characterizing the near full-length HIV genome and 50 established HDF genes, designed to evaluate anti-HIV gene therapy strategies. We implemented the platform to investigate the capacity of multiplexed CRISPR-Cas9 ribonucleoprotein complexes (Cas9-RNPs) to simultaneously 1) inactivate the HIV provirus, and 2) knockout the CCR5 and CXCR4 HDF (entry co-receptor) genes in microglia and primary monocyte-derived macrophages (MDMs). Our scDNA-seq pipeline revealed that antiviral gene editing is rarely observed at multiple loci (or both alleles of a locus) within an individual cell, and editing probabilities across sites are linked. Our results demonstrate that single-cell sequencing is critical to evaluate the true efficacy and therapeutic potential of HIV gene therapy.

The Outcomes of Endodontically Treated Teeth Restored with Custom-Made Cast Post-and-Core Restorations: A Retrospective Cohort Study.

INTRODUCTION: Custom-made cast post-and-core (CMCPC) restorations have long been used to restore structurally deficient endodontically treated teeth (ETT). However, the evidence regarding their impact on the outcomes of ETT is largely inconclusive. This study evaluated the long-term treatment outcome of ETT restored with CMCPC. METHODS: This retrospective cohort study examined the dental records of patients that received CMCPC at a specialty private practice in Toronto, Canada between 1999 and 2021. The proportion of ETT with complete periapical healing and those that survived were estimated, and prognostic factors were investigated using multiple logistic and Cox regression analyses respectively (P < .05). RESULTS: A total of 500 and 1000 teeth met periapical healing and survival criteria, respectively. The periapical healing rate was 88.8% and was associated with the presence of baseline periapical radiolucency [odds ratio = 0.1; 95% confidence interval (CI), 0.05-0.2; P < .001]. The survival after a median follow-up time of 52.9 months (interquartile range: 26.5-99.4) was 90.1% and was associated with <75% of root length in bone [hazard ratio (HR) = 2.6; 95% CI, 1.0-6.6; P = .033], type and quality of final restoration (HR = 2.09; 95% CI, 1.1-3.9; P = .020; HR = 2.3; 95% CI, 1.2-4.5; P = .008, respectively), and the presence of periapical radiolucency at the latest recall (HR = 3.2; 95% CI, 1.7-6.3; P < .001). CONCLUSIONS: The outcome of ETT restored with CMCPC was favorable. CMCPC may be regarded as a viable restorative option for structurally deficient ETT.

Unilateral Absent Pulmonary Artery in Pregnancy: A Case Report and Systematic Literature Review.

OBJECTIVE: Unilateral absence of a pulmonary artery (UAPA) is a rare congenital malformation associated with hemoptysis, pulmonary hypertension, and infection. Little is known about the impact on pregnancy outcomes. We sought to synthesize the existing literature on pregnancy outcomes in patients with maternal UAPA. STUDY DESIGN: We report a case of maternal UAPA and performed a systematic review of the existing literature. Articles in English reporting pregnancy outcomes among women with unilateral absence or hypoplasia of the pulmonary artery were included. Articles were reviewed at the abstract level and, if eligible, at the full-text level by two independent reviewers with disagreements adjudicated by a third reviewer. Data were abstracted by two independent reviewers. Outcomes of interest were mode of delivery, gestational age at delivery, intensive care admission, maternal death, and length of stay. Summary statistics for each outcome are presented. RESULTS: We identified 14 studies, including the presented case, reporting outcomes in 22 pregnancies impacted by maternal UAPA. Median age at diagnosis was 21 years. Concurrent cardiac comorbidities were reported in 6/13 (46.2%) with pulmonary hypertension in 5/20 (25%) of cases where this information was reported. We observed high rates of preterm birth (4/12, 33.3%), cesarean delivery (10/15, 66.7%), and operative vaginal delivery (2/5, 40.0%). There was one maternal death occurring in the immediate postpartum period for a mortality rate of 4.5%. CONCLUSION: Our study provides a comprehensive review of existing literature on maternal UAPA. Our findings suggest increased rates of adverse outcomes and underscore the importance of early diagnosis, identification of pulmonary hypertension, and multidisciplinary care. KEY POINTS: · There may be increased adverse outcomes in maternal UAPA.. · Concurrent cardiac abnormalities are common in maternal UAPA.. · Early diagnosis, identification of pulmonary hypertension, and multidisciplinary care are important..

Immunogenicity and safety of a new quadrivalent HPV vaccine in girls and boys aged 9-14 years versus an established quadrivalent HPV vaccine in women aged 15-26 years in India: a randomised, active-controlled, multicentre, phase 2/3 trial.

BACKGROUND: To meet global cervical cancer elimination efforts, a wider range of affordable and accessible vaccines against human papillomavirus (HPV) are needed. We aimed to evaluate the immunogenicity and safety of a quadrivalent HPV vaccine (targeting HPV types 6, 11, 16, and 18), developed and manufactured by the Serum Institute of India (SIIPL). Here we report outcomes in the 9-14 years cohort. METHODS: This randomised, active-controlled, phase 2/3 trial was conducted at 12 tertiary care hospitals across India. Healthy participants aged 9-14 years or 15-26 years with no history of HPV vaccination were eligible for enrolment. Female participants were randomly assigned (1:1) with an interactive web response system, by use of a central computer-generated schedule and block randomisation (block sizes of 2, 4, 6, and 8), to receive the SIIPL quadrivalent HPV vaccine (Cervavac; SIIPL, Pune, India) or the comparator quadrivalent HPV vaccine (Gardasil; Merck Sharp & Dohme, Harleem, the Netherlands). Participants, investigators, laboratory technicians, and sponsors were masked to treatment allocation of female participants. Male participants were given the SIIPL quadrivalent HPV vaccine in an open-label manner. Study vaccines were administered intramuscularly with a two-dose schedule (at day 0 and 6 months) in the cohort aged 9-14 years, and with a three-dose schedule (at day 0, month 2, and month 6) in the cohort aged 15-26-years. Immunogenicity was assessed 30 days after the last dose by use of multiplexed ELISA. The primary outcome was the non-inferiority of immune response in terms of the geometric mean titre (GMT) of antibodies against HPV types 6, 11, 16, and 18 generated by the SIIPL quadrivalent HPV vaccine in girls and boys (aged 9-14 years) compared with the GMT generated by the comparator quadrivalent HPV vaccine in women aged 15-26 years at month 7 in the modified per-protocol population (ie, all participants who received all doses of study vaccines per assigned treatment group and had both day 0 and 1-month immunogenicity measurements after the last dose following protocol-defined window periods with no major protocol deviations). Non-inferiority was established if the lower bound of the 98·75% CI of the GMT ratio was 0·67 or higher. The co-primary outcome of occurrence of solicited adverse events (within 7 days of each dose) and unsolicited adverse events (up to 30 days after the last dose) was assessed in all participants who were enrolled and received at least one dose of study vaccine. The trial is registered with the Clinical Trials Registry - India (CTRI/2018/06/014601), and long-term follow-up is ongoing. FINDINGS: Between Sept 20, 2018, and Feb 9, 2021, 2341 individuals were screened, of whom 2307 eligible individuals were enrolled and vaccinated: 1107 (738 girls and 369 boys) in the cohort aged 9-14 years and 1200 (819 women and 381 men) in the cohort aged 15-26 years. No race or ethnicity data were collected. 350 girls and 349 boys in the SIIPL quadrivalent HPV vaccine group and 338 women in the comparator vaccine group were included in the modified per-protocol population for the primary endpoint analysis. The median follow-up for the analyses was 221 days (IQR 215-231) for girls and 222 days (217-230) for boys in the SIIPL quadrivalent HPV vaccine group, 223 days (216-232) for girls in the comparator vaccine group, and 222 days (216-230) for women in the comparator vaccine group. GMT ratios were non-inferior in girls and boys receiving the SIIPL quadrivalent HPV vaccine compared with women receiving the comparator vaccine: GMT ratios for girls were 1·97 (98·75% CI 1·67-2·32) for HPV type 6, 1·63 (1·38-1·91) for HPV type 11, 1·90 (1·60-2·25) for HPV type 16, and 2·16 (1·79-2·61) for HPV type 18. For boys the GMT ratios were 1·86 (1·57-2·21) for HPV type 6, 1·46 (1·23-1·73) for HPV type 11, 1·62 (1·36-1·94) for HPV type 16, and 1·80 (1·48-2·18) for HPV type 18. The safety population comprised all 1107 participants (369 girls and 369 boys in the SIIPL quadrivalent HPV vaccine group, and 369 girls in the comparator group). Solicited adverse events occurred in 176 (48%) of 369 girls and 124 (34%) of 369 boys in the SIIPL vaccine group and 179 (49%) of 369 girls in the comparator vaccine group. No grade 3-4 solicited adverse events occurred within 7 days of each dose. Unsolicited adverse events occurred in 143 (39%) girls and 147 (40%) boys in the SIIPL vaccine group, and 143 (39%) girls in the comparator vaccine group. The most common grade 3 unsolicited adverse event was dengue fever, in one (<1%) girl in the SIIPL vaccine group and three (1%) girls in the comparator group. There were no grade 4 or 5 adverse events. Serious adverse events occurred in three (1%) girls and three (1%) boys in the SIIPL vaccine group, and five (1%) girls in the comparator vaccine group. No vaccine-related serious adverse events were reported. There were no treatment-related deaths. INTERPRETATION: We observed a non-inferior immune response with the SIIPL quadrivalent HPV vaccine in girls and boys aged 9-14 years and an acceptable safety profile compared with the comparator vaccine. These findings support extrapolation of efficacy from the comparator vaccine to the SIIPL quadrivalent HPV vaccine in the younger population. The availability of the SIIPL quadrivalent HPV vaccine could help meet the global demand for HPV vaccines, and boost coverage for both girls and boys globally. FUNDING: Biotechnology Industry Research Assistance Council, Department of Biotechnology (DBT), Government of India, and Serum Institute of India.

Safety and immunogenicity of SIIPL Tdap, a new tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, in healthy subjects 4-65 years of age: A Phase II/III randomized, observer-blinded, active controlled, multicenter clinical study in Germany.

BACKGROUND: This study assessed the safety and immunogenicity of a new booster vaccine against tetanus, diphtheria, and pertussis manufactured by Serum Institute of India Pvt. Ltd (SIIPL Tdap). METHODS: The Phase II/III trial was randomized (2:1), observer blinded and active controlled. Healthy subjects aged 4-65 years received a single dose of either SIIPL Tdap or comparator Tdap vaccine (Boostrix®, GlaxoSmithKline, Belgium), and were followed-up for 30 days. Blood samples for safety and immunogenicity assessments were collected pre-vaccination and on day 30 post-vaccination. The study assessed safety and reactogenicity of SIIPL Tdap compared to the comparator Tdap as well as the co-primary immunogenicity outcomes: (i) seroprotection rates against diphtheria toxoid (DT) and tetanus toxoid (TT) and (ii) the booster response rates against pertussis toxoid (PT), filamentous hemagglutinin (FHA) and pertactin (PRN) 30 days post-vaccination in all study subjects. A margin of -10 % was used for non-inferiority testing. Secondary outcomes included the booster response rates against DT and TT, seropositivity rates against pertussis antigens, and antibody geometric mean concentrations (GMCs) for all vaccine components. RESULTS: At Day 30 post-vaccination, SIIPL Tdap was assessed as non-inferior to the comparator Tdap in terms of: i) seroprotection rates against DT (94.4 % vs. 94.9 %) and TT (99.9 % vs. 100 %) and ii) pertussis booster response rates (93.8 % vs. 88.4 % anti-PT, 89.7 % vs. 90.9 % anti-FHA and 86.3 % vs. 84.4 % anti-PRN), for SIIPL Tdap versus comparator Tdap, respectively. GMCs for anti-PT and anti-PRN were higher in subjects vaccinated with SIIPL Tdap compared to comparator Tdap. All other secondary outcomes were comparable. The overall frequency of local and systemic solicited AEs was comparable; no treatment related SAEs were reported. CONCLUSIONS: Booster vaccination with SIIPL Tdap was non-inferior to comparator Tdap with respect to the immunogenicity of the vaccine components and was equally well tolerated. EudraCT number: 2019-002706-46.

Characterizing rheological properties and microstructure of thioester networks during degradation.

Covalent adaptable networks are designed for applications including cell and drug delivery and tissue regeneration. These applications require network degradation at physiological conditions and on a physiological timescale with microstructures that can: (1) support, protect and deliver encapsulated cells or molecules and (2) provide structure to surrounding tissue. Due to this, the evolving microstructure and rheological properties during scaffold degradation must be characterized. In this work, we characterize degradation of covalent adaptable poly(ethylene glycol) (PEG)-thioester networks with different amounts of excess thiol. Networks are formed between PEG-thiol and PEG-thioester norbornene using photopolymerization. These networks are adaptable because of a thioester exchange reaction that takes place in the presence of excess thiol. We measure degradation of PEG-thioester networks with L-cysteine using multiple particle tracking microrheology (MPT). MPT measures the Brownian motion of fluorescent probe particles embedded in a material and relates this motion to rheological properties. Using time-cure superposition (TCS), we characterize the microstructure of these networks at the gel-sol phase transition by calculating the critical relaxation exponent, n, for each network with different amounts of excess thiol. Based on the measured n values, networks formed with 0% and 50% excess thiol are tightly cross-linked and elastic in nature. While networks formed with 100% excess are similar to ideal, percolated networks, which have equal viscous and elastic components. MPT measurements during degradation of these networks also measure a non-monotonic increase in probe motility. We hypothesize that this is network rearrangement near the phase transition. We then measure macroscopic material properties including the equilibrium modulus and stress relaxation. We measure a trend in bulk network properties that agrees with the values of n. Elastic modulus and stress relaxation measurements show that networks with 50% excess thiol are more elastic compared to the other two networks. As the amount of excess thiol is increased from 0% to 50%, the networks become more elastic. Further increasing excess thiol to 100% reduces the elastically effective cross-links. We hypothesize that these properties are due to network non-idealities, resulting in networks with 50% excess thiol that are more elastic. This work characterizes dynamic rheological properties during degradation, which mimics processes that could occur during implantation. This work provides information that can be used in the future design of implantable materials enabling both the rheological properties and timescale of degradation to be specified.

Impact of methocarbamol on opioid use after ventral incisional hernia repair.

BACKGROUND: Alternatives to opioid analgesia are needed to reduce the risk of abuse, misuse, and diversion. Musculoskeletal pain is a significant contributor to postoperative pain after ventral hernia repair (VHR). We report the impact of methocarbamol on opioid prescribing after VHR. METHODS: Review of all robotic and open VHR, Jan 2020-July 2022. Data was collected in the Abdominal Core Health Quality Collaborative (ACHQC) with additional chart review to assess for opioid refills. A 2:1 propensity score match was performed comparing opioid prescribing in patients prescribed vs not prescribed methocarbamol. RESULTS: 101 patients received methocarbamol compared with 202 without. Similar number of patients received an opioid prescription (87.1 vs 86.6%; p = 0.904). Study patients received significantly lower MME prescription at discharge (60 v 75; p = 0.021) with no difference in refills (12.5 vs 16.6%; p = 0.386). CONCLUSION: Addition of methocarbamol to a multimodal analgesic regimen after VHR facilitates reduction in prescribed opioid with no increase in refills.

Impact of methocarbamol on opioid use after primary ventral and inguinal hernia repair.

BACKGROUND: Multimodal analgesia is now a mainstay of perioperative care. Our aim is to assess the impact of adding methocarbamol on opioid use for patients undergoing primary ventral (umbilical and epigastric) hernia repair (PVHR) and inguinal hernia repair (IHR). METHODS: Retrospective review of patients undergoing PVHR and IHR who received methocarbamol, propensity score matched in a 2:1 fashion to patients not receiving methocarbamol. RESULTS: Fifty-two PVHR patients receiving methocarbamol were matched to 104 control patients. Study patients were prescribed fewer opioids (55.8 vs 90.4%; p < 0.001) and received lower MME (20 vs 50; p < 0.001), with no difference in refills or rescue opioids. For IHR, study patients received fewer prescriptions (67.3 vs 87.5%; p < 0.001) and received lower MME (25 vs 40; p < 0.001), with no difference in rescue opioid (5.9 vs 0%; p = 0.374). CONCLUSIONS: Methocarbamol significantly reduced opioid prescribing in patients undergoing PVHR and IHR without increasing the risk of refill or rescue opioid.

A Phase I study to evaluate safety and tolerability of DTaP-IPV + Hib vaccine in healthy adult volunteers in India.

Background: To assess safety and tolerability of a diphtheria and tetanus toxoid, acellular pertussis, inactivated poliovirus and Haemophilus influenza type B conjugate adsorbed vaccine (DTaP-IPV + Hib), manufactured by Serum Institute of India Pvt. Ltd. (SIIPL)'s, the current first-in-human Phase 1 study was conducted in healthy adults. Methods: Vaccine was administered as a single 0.5 mL dose intramuscularly into deltoid muscle of 24 healthy adults aged 18-45 years, who were then followed prospectively for one month for safety outcomes. Results: All 24 participants completed the study in compliance with protocol. Four solicited adverse events were reported in three participants during the study; all adverse events were mild and recovered completely. No deaths, unsolicited adverse events, or serious adverse events were reported. Conclusion: SIIPL DTaP-IPV + Hib vaccine was well tolerated and safe in study subjects. Further clinical development will be conducted to assess safety and immunogenicity in young children, the target population.Clinical Trial Registration: CTRI/2017/07/009034.

A phase-I, open label clinical trial to assess the safety & tolerability of qHPV vaccine manufactured by Serum Institute of India Pvt. Ltd. in adults.

Background: This first in human study was designed as an open label clinical trial to assess safety and tolerability of Serum Institute of India Pvt. Ltd. (SIIPL) quadrivalent HPV (qHPV) vaccine. Methods: A total of 48 healthy male and female (24 each) adult volunteers were administered a 0.5 ml single dose of SIIPL qHPV vaccine intramuscularly, and were followed for one month for safety outcomes viz., immediate, solicited, unsolicited and serious adverse events. Results: 47 subjects completed the study in compliance with protocol. One subject had pain immediately after immunization which was recovered without treatment. None of the participants experienced any other local or systemic solicited AEs and serious AE. Conclusion: qHPV vaccine manufactured by SIIPL was found to be safe and well tolerable in adults. Further clinical development should continue to assess safety and immunogenicity, in the target population following recommended 2 and 3-dose schedule.Clinical Trial Registration - CTRI/2017/02/007785.

A Retrospective Study on Endodontic Treatment Outcomes in Patients With Special Needs.

INTRODUCTION: Outcomes of endodontic treatment in patients with special needs are not fully understood, leading to reluctance in performing endodontic treatment. METHODS: This retrospective cohort study evaluated the periapical healing and tooth survival in patients with special needs who had permanent teeth endodontically treated in a hospital setting between 1998 and 2019. Data characterization was performed using univariate analyses. Logistic and Cox regression analyses (P < .05) were performed to identify the odds ratio (OR) and hazard ratio (HR) of the potential prognostic factors, respectively. These predictors were chosen from previous outcome studies in the general population and patients with special needs. RESULTS: A total of 61 patients (108 teeth) met the inclusion criteria. The most common treatment modality was initial therapy with 81.5% of cases being managed without a need for general anesthesia. Healing rate for initial endodontic treatment was 89.9% and was affected by no restoration at follow-up (OR = 0.15; 95% confidence interval [CI], 0.12-0.71; P = .02). After a mean follow-up of 79.36 ± 59.6 months, the survival rate was 73% and was correlated with gender (HR for males = 0.3; 95% CI, 0.1-0.6; P < .05) and age (HR for patients >45 years = 3.7; 95% CI, 1.7-8.2; P < .05). The most common reason for tooth extraction was unrestorable tooth fracture. CONCLUSIONS: Endodontic therapy without a need for general anesthesia is a viable treatment option for patients with special needs. If the overall patient condition permits, then treatment can be administered by community dentists rather than waiting for a patient to be seen in a hospital setting.

Physical and functional stability of spray-dried jamun (Syzygium cumini L.) juice powder produced with different carrier agents.

Jamun (Syzygium cumini L.) fruit is an underutilized source of bioactive phytochemicals. Therefore, preserving this fruit in various forms over the year is necessary. Spray drying can effectively preserve jamun juice; but the stickiness issue of fruit juice powder mainly arises during the drying, which may be overcome by using different carriers. Consequently, this experiment aimed to ascertain the effect of different carrier types (maltodextrin, gum arabic, whey protein concentrate, waxy starch, and maltodextrin: gum arabic) on the physical, flow, reconstitution, functional, and color stability of spray-dried jamun juice powder. The physical parameters of the produced powder such as moisture content, bulk, and tapped density were in the range of 2.57%-4.95% (w.b.), 0.29-0.50 and 0.45-0.63 g/mL, respectively. The powder yield ranged between 55.25% and 75.9%. The flow characteristics, Carr's index and Hausner ratio, were in the range of 20.89-35.90 and 1.26-1.56, respectively. Reconstitution attributes viz., wettability, solubility, hygroscopicity, and dispersibility were in the range of 90.3-199.7 s, 55.28%-95%, 15.23-25.86 g/100 g, and 70.97%-95.79%, respectively. The functional attributes include total anthocyanin, total phenol content, and encapsulation efficiency, were in the range of 75.13-110.01 mg/100 g, 129.48-215.02 g GAE/100 g, and 40.49%-74.07%, respectively. The L*, a*, and b* values ranged from 41.82 to 70.86, 14.33 to 23.04, -8.12 to -0.60, respectively. A combination of maltodextrin and gum arabic was found effective in producing jamun juice powder with appropriate physical, flow, functional, and color attributes.

Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India.

BACKGROUND: This study assessed safety and immunogenicity of Serum Institute of India Pvt Ltd (SIIPL)'s tetanus toxoid (TT), diphtheria toxoid (DT), and acellular pertussis booster vaccine (Tdap). RESEARCH DESIGN AND METHODS: In this Phase II/III, multicenter, randomized, active-controlled, open-label study, 1500 healthy individuals, aged 4-65 years, were randomized to receive a single dose of SIIPL Tdap or comparator Tdap vaccine (Boostrix®; GlaxoSmithKlines, India). Adverse events (AEs) during initial 30 minutes, 7-day, 30-day post-vaccination were assessed. Blood samples were taken before and 30 days post-vaccination for immunogenicity assessment. RESULTS: No significant differences in incidence of local and systemic solicited AEs were observed between the two groups; no vaccine-related serious AEs were reported. SIIPL Tdap was non-inferior to comparator Tdap in achieving booster responses to TT and DT in 75.2% and 70.8% of the participants, respectively, and to pertussis toxoid (PT), pertactin (PRN), and filamentous hemagglutinin (FHA) in 94.3%, 92.6%, and 95.0% of the participants, respectively. Anti-PT, anti-PRN, and anti-FHA antibody geometric mean titers in both the groups, were significantly higher post-vaccination compared to pre-vaccination. CONCLUSIONS: Booster vaccination with SIIPL Tdap was non-inferior to comparator Tdap with respect to immunogenicity against tetanus, diphtheria, and pertussis and was well tolerated.