Hindi translation and cultural adaptation of the quality of recovery score-40 (QoR-40 score): A validation study.

Background And Aims: The quality of recovery (QoR)-40 score has been used worldwide and validated in many surgical cohorts to assess global patient recovery. We aim to translate and culturally adapt the QoR-40 score into Hindi and test the validity and reliability of the translated version in patients undergoing cancer surgery.

Methods: The translation of the QoR-40 questionnaire was based on the forward and backward translation methods.

Pharmacokinetics, Safety, and Tolerability of Once-Daily Darunavir With Cobicistat and Weekly Isoniazid/Rifapentine.

Background: Once-weekly isoniazid with rifapentine (HP) for 3 months is a recommended treatment for latent tuberculosis infection in persons with HIV. HP reduces exposures of certain antiretroviral medications, resulting in limited options for the concomitant use of these therapies. Here, we examined the pharmacokinetics (PK), safety, and tolerability of darunavir/cobicistat with HP.

Postoperative acute pain management with duloxetine as compared to placebo: A systematic review with meta-analysis of randomized clinical trials.

Background: Duloxetine has been used as an adjunct in multimodal analgesia for acute postoperative pain in clinical studies. This meta-analysis aims to conclude whether oral duloxetine, when given perioperatively, is any better than a placebo in managing postoperative pain. Effects of duloxetine on postoperative pain scores, time to first rescue analgesia, postoperative rescue analgesia consumption, side effects attributable to duloxetine, and patient satisfaction profile were assessed.

Leveraging patient-centric sampling for clinical drug development and decentralized clinical trials: Promise to reality.

Advances in the technologies to enable patient-centric sampling (PCS) have the potential to improve blood sample collection by enabling clinical trial participants to collect samples via self-collection or with the help of a caregiver in their home. Typically, blood samples to assess pharmacokinetics and pharmacodynamics of a drug during clinical development are collected at a clinical site via venous blood draw. In this position paper by the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), the potential value PCS can bring to patients, to the clinical datasets generated, and to clinical trial sponsors is discussed, along with considerations for program decision making, bioanalytical feasibility, operations, and regulatory implications.

Comparative evaluation of analgesic efficacy of buprenorphine transdermal patch and fentanyl patch in management of postoperative pain after arthroscopic lower limb surgery: A randomized controlled trial.

Background And Aims: Transdermal opioids are newer modality in use for the control of postoperative pain, because of its noninvasiveness, longer duration of action, sustained blood levels, and with minimal side effects. The study was aimed to evaluate the efficacy of analgesia of buprenorphine patch 10, 20 μg·h and fentanyl patch 25 μg·h for relief of pain in the postoperative period in patients undergoing arthroscopic lower limb surgeries.

Materials And Methods: It was a randomized, double-blinded, prospective study in which adult patients undergoing lower limb arthroscopic surgery were randomly segregated into three groups.

A Novel Encochleated Formulation Improves Atovaquone Activity in a Murine Model of Pneumocystis Pneumonia.

Although atovaquone is effective in treating and preventing Pneumocystis pneumonia (PCP), its use is limited by nonlinear absorption and adverse events. The current study was undertaken to examine the activity of encochleated atovaquone (eATQ), a novel lipid-crystal nanoparticle formulation, in a mouse model of PCP. eATQ 100-200 mg was superior to commercially available atovaquone at 14 days in decreasing total Pneumocystis nuclei and asci.

Quantitative Benefit-Risk Assessment of P-gp-Mediated Drug-Drug Interactions of Dabigatran Coadministered With Pharmacokinetic Enhancers in Patients With Renal Impairment.

Drug-drug interactions (DDIs) between dabigatran and ritonavir/cobicistat are of major concern in people living with HIV, particularly in those with impaired renal function, because they can result in increased dabigatran exposure and thus an increased risk of major bleeding events. However, the extent of this interaction and subsequent need for dose adjustment in subjects with varying degrees of renal function is currently not yet fully understood. To close this knowledge gap, we conducted an integrated population physiologically-based pharmacokinetic/pharmacodynamic analysis linking changes in dabigatran exposure due to DDIs and varying degrees of renal function to the probability of experiencing an ischemic stroke or major bleeding event within 1 year.

Translation, cultural adaptation, and validation of the duke activity status index in the hindi language.

Background: The Duke Activity Status Index (DASI) is a validated questionnaire in English to assess the functional capacity (FC) of patients with cardiovascular disease (CVD). Aim: The aim of the study is to translate, cross-culturally adapt, and validate the DASI in Hindi.

Settings And Study Design: Observational validation study.

A prospective evaluation on the interaction of fluconazole and voriconazole on serum concentrations of budesonide in patients treated for gastrointestinal GVHD.

The gastrointestinal (GI) tract is commonly affected by acute and chronic graft-versus-host disease (GVHD) in patients who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT). For patients developing GI GVHD, nonabsorbable corticosteroids such as budesonide may be used alone to reduce the risk of systemic corticosteroid toxicities or combined with systemic steroids to enhance clinical responses and to allow more rapid tapering of systemic corticosteroid doses. This prospective crossover study was conducted to evaluate what effect two commonly used antifungal agents, fluconazole, and voriconazole, would have on the trough (Cmin) and peak (Cmax) levels of budesonide in adult patients who had undergone allo-HSCT who subsequently developed clinical GI GVHD.

Perioperative duloxetine as part of a multimodal analgesia regime reduces postoperative pain in lumbar canal stenosis surgery: a randomized, triple blind, and placebo-controlled trial.

Background: Duloxetine is an antidepressant that is also useful in chronic neuropathic and central origin pain. In this study, the role of duloxetine in decreasing acute postoperative pain after lumbar canal stenosis surgery is explored.

Methods: In this single center, triple blinded, and placebo-controlled trial, 96 patients were randomized for statistical analysis.

Atypical Presentation of Viral Gastroenteritis in a Three-year-old Child Due to a UNC80 Mutation.

We report a three-year-old child with a rare genetic phenomenon, a UNC80 mutation, who had an unusual presentation of viral gastroenteritis. The UNC80 gene encodes for an important voltage-independent channel in neurons and a mutation in this protein can lead to severe hypotonia. The hypotonia manifests as delayed gastric emptying, impaired respiratory clearance, and/or delayed muscle coordination, which can predispose to infection susceptibility.

Intraoperative Comparison and Evaluation of Intrathecal Bupivacaine Combined with Clonidine versus Fentanyl in Children Undergoing Hernia Repair or Genital Surgery: A Prospective, Randomized Controlled Trial.

Background: Nowadays, spinal anesthesia is commonly being used in infants and children for infraumblical surgeries. Intrathecal adjuvants such as clonidine and fentanyl are used with local anesthetics for additive effects.

Aim: The present study aims to assess and compare the effects of adding clonidine versus fentanyl to bupivacaine intrathecally in terms of propofol consumption, hemodynamic profile, adverse events, and complications intraoperatively in pediatric patients.

Comparison of Subcostal Transversus Abdominis Block with Intraperitoneal Instillation of Levobupivacaine for Pain Relief after Laparoscopic Cholecystectomy: A Prospective Study.

Background: There are several methods employed in the management of postoperative pain after laparoscopic cholecystectomy such as conventional systemic analgesics, including paracetamol, non-steroidal anti-inflammatory drugs, systemic opioids, and thoracic epidural analgesia with all having its limitations and side effects.

Aims: The present study aims to compare ultrasound-guided subcostal transversus abdominis (STA) block with intraperitoneal instillation of levobupivacaine in reducing postoperative pain, total analgesic consumption, nausea and vomiting, and recovery time in patients after elective laparoscopic cholecystectomy.

Settings And Design: A prospective study was conducted between January 2017 and December 2017 in 80 patients undergoing elective laparoscopic cholecystectomy after approval of the Institutional Ethical Committee (Reference No: SGRR/IEC/05/16).

Immune regulation by glucocorticoids can be linked to cell type-dependent transcriptional responses.

Glucocorticoids remain the most widely used immunosuppressive and anti-inflammatory drugs, yet substantial gaps exist in our understanding of glucocorticoid-mediated immunoregulation. To address this, we generated a pathway-level map of the transcriptional effects of glucocorticoids on nine primary human cell types. This analysis revealed that the response to glucocorticoids is highly cell type dependent, in terms of the individual genes and pathways affected, as well as the magnitude and direction of transcriptional regulation.

Mononuclear phagocyte system function and nanoparticle pharmacology in obese and normal weight ovarian and endometrial cancer patients.

Purpose: Obesity may alter mononuclear phagocyte system (MPS) function and the pharmacology and efficacy of nanoparticles therapies, such as PEGylated liposomal doxorubicin (PLD). We aimed to evaluate the relationships between hormone and chemokine mediators of MPS function and the pharmacokinetic (PK) exposure of PLD in obese and normal weight patients with ovarian and endometrial cancer.

Methods: Hormone and chemokine mediators in obese and normal weight ovarian and endometrial cancer patients were measured.

Safety and efficacy of low-dose sirolimus in the PIK3CA-related overgrowth spectrum.

Purpose: PIK3CA-related overgrowth spectrum (PROS) encompasses a range of debilitating conditions defined by asymmetric overgrowth caused by mosaic activating PIK3CA variants. PIK3CA encodes the p110α catalytic subunit of phosphatidylinositol-3-kinase (PI3K), a critical transducer of growth factor signaling. As mTOR mediates the growth-promoting actions of PI3K, we hypothesized that the mTOR inhibitor sirolimus would slow pathological overgrowth.

Long-term use of continuous subcutaneous hydrocortisone infusion therapy in patients with congenital adrenal hyperplasia.

Background: In a phase 2 short-term (6 months) study of patients with congenital adrenal hyperplasia (CAH), continuous subcutaneous hydrocortisone infusion (CSHI) was found to be a safe, effective and well-tolerated method of replacing cortisol with improved disease and patient-related outcomes.

Objective: To evaluate the safety and efficacy of long-term CSHI.

Design: Single-centre, open-label, phase 2 extension study.

Potential Influence of Centrally Acting Herbal Drugs on Transporters at the Blood-Cerebrospinal Fluid Barrier and Blood-Brain Barrier.

Complementary and alternative medications (CAM) with known or suspected pharmacologic activity in the central nervous system (CNS) are common. These herbal preparations may cause clinically significant drug-drug interactions (DDIs) when coadministered with medications that act in the CNS. This can result in negative outcomes such as toxicity or loss of efficacy.

JAK1/2 inhibition with baricitinib in the treatment of autoinflammatory interferonopathies.

Background: Monogenic IFN-mediated autoinflammatory diseases present in infancy with systemic inflammation, an IFN response gene signature, inflammatory organ damage, and high mortality. We used the JAK inhibitor baricitinib, with IFN-blocking activity in vitro, to ameliorate disease.

Methods: Between October 2011 and February 2017, 10 patients with CANDLE (chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperatures), 4 patients with SAVI (stimulator of IFN genes-associated [STING-associated] vasculopathy with onset in infancy), and 4 patients with other interferonopathies were enrolled in an expanded access program.

Cytokine-Mediated Systemic Adverse Drug Reactions in a Drug-Drug Interaction Study of Dolutegravir With Once-Weekly Isoniazid and Rifapentine.

Background: Once-weekly isoniazid and rifapentine for 3 months is a treatment option in persons with human immunodeficiency virus and latent tuberculosis infection. This study aimed to examine pharmacokinetic drug-drug interactions between this regimen and dolutegravir, a first-line antiretroviral medication.

Methods: This was a single-center, open-label, fixed-sequence, drug-drug interaction study in healthy volunteers.