Publications by authors named "Hiral Shah"

66 Publications

Enhanced Solubility and Bioavailability of Dolutegravir by Solid Dispersion Method: In Vitro and In Vivo Evaluation-a Potential Approach for HIV Therapy.

AAPS PharmSciTech 2021 Apr 9;22(3):127. Epub 2021 Apr 9.

Department of Pharmaceutics, Institute of Pharmacy, Nirma University, Ahmedabad, 382481, India.

Being a candidate of BCS class II, dolutegravir (DTG), a recently approved antiretroviral drug, possesses solubility issues. The current research was aimed to improve the solubility of the DTG and thereby enhance its efficacy using the solid dispersion technique. In due course, the miscibility study of the drug was performed with different polymers, where Poloxamer 407 (P407) was found suitable to move forward. The solid dispersion of DTG and P407 was formulated using solvent evaporation technique with a 1:1 proportion of drug and polymer, where the solid-state characterization was performed using differential scanning calorimetry, Fourier transform infrared spectroscopy and X-ray diffraction. No physicochemical interaction was found between the DTG and P407 in the fabricated solid dispersion; however, crystalline state of the drug was changed to amorphous as evident from the X-ray diffractogram. A rapid release of DTG was observed from the solid dispersion (>95%), which is highly significant (p<0.05) as compared to pure drug (11.40%), physical mixture (20.07%) and marketed preparation of DTG (35.30%). The drug release from the formulated solid dispersion followed Weibull model kinetics. Finally, the rapid drug release from the solid dispersion formulation revealed increased C (14.56 μg/mL) when compared to the physical mixture (4.12 μg/mL) and pure drug (3.45 μg/mL). This was further reflected by improved bioavailability of DTG (AUC: 105.99±10.07 μg/h/mL) in the experimental Wistar rats when compared to the AUC of animals administered with physical mixture (54.45±6.58 μg/h/mL) and pure drug (49.27±6.16 μg/h/mL). Therefore, it could be concluded that the dissolution profile and simultaneously the bioavailability of DTG could be enhanced by means of the solid dispersion platform using the hydrophilic polymer, P407, which could be projected towards improved efficacy of the drug in HIV/AIDS.
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http://dx.doi.org/10.1208/s12249-021-01995-yDOI Listing
April 2021

The impact of COVID-19 and social distancing on people with Parkinson's disease: a survey study.

NPJ Parkinsons Dis 2021 Jan 21;7(1):10. Epub 2021 Jan 21.

Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA.

As the COVID-19 pandemic continues to affect the international community, very little is known about its impact on the health and day-to-day activities of people with Parkinson's disease (PwPD). To better understand the emotional and behavioral consequences of the public health policies implemented to mitigate the spread of SARS-CoV-2 in PwPD, and to explore the factors contributing to accessing alternative health care mechanisms, such as telehealth, we administered an anonymous knowledge, attitude, and practice survey to PwPD and care partners, via the mailing lists of the Parkinson's Foundation and Columbia University Parkinson's Disease Center of Excellence with an average response rate of 19.3%. Sufficient information was provided by 1,342 PwPD to be included in the final analysis. Approximately half of respondents reported a negative change in PD symptoms, with 45-66% reporting mood disturbances. Telehealth use increased from 9.7% prior to the pandemic to 63.5% during the pandemic. Higher income and higher education were associated with telehealth use. Services were more often used for doctor's appointment than physical, occupational, speech, or mental health therapies. Almost half (46%) of PwPD preferred to continue using telehealth always or sometimes after the coronavirus outbreak had ended. Having received support/instruction for telehealth and having a care partner, friend, or family member to help them with the telehealth visit increased the likelihood of continuous use of telehealth after the pandemic ended. Taken together, PD symptoms and management practices were markedly affected by COVID-19. Given the observed demographic limitations of telehealth, expanding its implementation to include additional physical, occupational, psychological, and speech therapies, increasing support for telehealth, as well as reaching underserved (low income) populations is urgently required.
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http://dx.doi.org/10.1038/s41531-020-00153-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7820020PMC
January 2021

Enhancement in antinociceptive and anti-inflammatory effects of tramadol by transdermal proniosome gel.

Asian J Pharm Sci 2020 Nov 19;15(6):786-796. Epub 2019 Jun 19.

College of Clinical Pharmacy, King Faisal University, Al-Ahsa 31982, Saudi Arabia.

Oral therapy of tramadol, an opiate analgesic, undergoes extensive hepatic metabolism and requires frequent administration. Transdermal therapy by virtue can overcome these issues and can improve the efficacy and reduce abuse liability of tramadol. The aim of this research was to investigate the possibility of transdermal delivery of tramadol by formulating proniosome gel and evaluate its therapeutic potential . The effect of formulation composition as well as amount of drug on physicochemical characteristics of prepared proniosomes were examined. Best proniosome gel (F4) was selected and evaluated for drug release, stability and transdermal efficacy by and experiments. The vesicles demonstrated optimal properties including spherical shape, nanosize with good entrapment efficiency, adequate zeta potential, higher stability and greater transdermal flux. The amorphization and dispersion of tramadol in the aqueous core of proniosome vesicles was confirmed by differential scanning calorimeter. Release profile of F4 was distinct ( < 0.001) from control and displayed steady and prolonged tramadol release by Fickian diffusion. Transdermal therapy of F4 showed prominent reduction of induced twitches ( < 0.005) in mice and edema ( < .05) in rats, as compared to oral tramadol. The improvement in clinical efficacy of tramadol in transdermal therapy is correlated with the pharmacokinetic data observed. In conclusion, the observed improvement in antinociceptive and anti-inflammatory effects from proniosome carriers signifies its potential to be a suitable alternative to oral therapy of tramadol with greater efficacy.
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http://dx.doi.org/10.1016/j.ajps.2019.05.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7750831PMC
November 2020

Eosinophilic gastroenteritis with gastric perforation-An unusual presentation.

Indian J Gastroenterol 2020 12;39(6):624-626

Department of Clinical Research, Surat Institute of Digestive Sciences, Majura Gate, Ring Road, Surat, 395 002, India.

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http://dx.doi.org/10.1007/s12664-020-01108-wDOI Listing
December 2020

A prospective, head-to-head comparison of 2 EUS-guided liver biopsy needles in vivo.

Gastrointest Endosc 2020 Oct 9. Epub 2020 Oct 9.

Department of Gastroenterology, Lehigh Valley Health Network, Allentown, Pennsylvania, USA.

Background And Aims: Procedural standardization in endoscopic ultrasound-guided liver biopsy (EUS-LB) is necessary to obtain core biopsy specimens for accurate diagnosis. The objective of this study was to directly compare the diagnostic yield of 2 EUS-LB fine-needle biopsy (FNB) systems in vivo.

Methods: In this prospective, single-center study, 108 adult patients undergoing EUS-LB over a 1-year period were included. Each EUS-LB consisted of an EGD, followed by EUS-guided biopsy of the left lobe of the liver sequentially using 2 different 19-gauge needles: the fork-tip (SharkCore) and Franseen (Acquire) FNB systems. Specimens were then reviewed by a GI histopathologist to determine diagnostic adequacy as well as the number of complete portal tracts, specimen length, and degree of fragmentation.

Results: In 79.4% of cases, the fork-tip FNB system yielded a final diagnosis compared with 97.2% of the Franseen FNB specimens (P < .001). The mean number of complete portal tracts in the fork-tip FNB samples was 7.07 compared with 9.59 in the Franseen FNB samples (P < .001). The mean specimen length was 13.86 mm for the fork-tip FNB and 15.81 mm for the Franseen FNB (P = .004). Cores were intact in 47.6% of the fork-tip FNB samples and in 75.2% of the Franseen FNB samples (P = .004).

Conclusions: In EUS-LB, we found that the 19-gauge Franseen FNB system resulted in a statistically significant increase in diagnostic adequacy compared with biopsy using the fork-tip FNB system.
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http://dx.doi.org/10.1016/j.gie.2020.09.050DOI Listing
October 2020

Promoting Physical Activity via Telehealth in People With Parkinson Disease: The Path Forward After the COVID-19 Pandemic?

Phys Ther 2020 09;100(10):1730-1736

Department of Neurology, Columbia University Irving Medical Center.

Objective: There is mounting evidence in support of exercise and physical activity as a first-line approach to managing symptoms and potentially altering disease progression in people with Parkinson disease (PD). For many patients, a critical gap is the need for expert guidance to overcome barriers, set realistic goals, and provide personalized advice to optimize exercise uptake and adherence. The purpose of this case report is to describe a physical activity coaching program (Engage-PD) for individuals newly diagnosed with PD and to highlight rapid modifications made to this program in response to the COVID-19 pandemic.

Methods (case Description): Engage-PD is a single cohort implementation study of a coaching intervention grounded in self-determination theory being conducted at Columbia University Parkinson's Foundation Center of Excellence in New York City, NY (USA), the early epicenter of the COVID-19 pandemic in the United States. The project was uniquely positioned to be adapted to telehealth delivery and to address an immediate need for support and guidance in the home environment, including people with early-mid-stage PD. Participants completed baseline and follow-up (3 months) assessments and participated in up to 4 coaching sessions, all delivered via a telehealth platform. The intervention incorporated 1:1 coaching, goal-setting, physical activity monitoring, and use of a disease-specific workbook to promote and support safe exercise uptake.

Results: While the program is ongoing, 52 referrals were received and 27 individuals with PD enrolled in the first 2 months of the pandemic for a recruitment rate of 52%. Although direct comparisons with pre-coronavirus recruitment are difficult due to the recency of the Engage-PD implementation study, this recruitment rate was larger than expected, which may have been due to several factors (eg, most patients had limited, if any, access to in-person programs and therapy services during this time, so the Engage program filled an immediate need to provide exercise and activity guidance). There was a wide range of scores for both baseline physical activity and self-efficacy measures.

Conclusion: Remotely delivered interventions may serve as a sustainable platform for physical activity coaching programs for people with PD as well as other neurodegenerative diseases.

Impact: With the uncertainty brought about by the current pandemic, this case report highlights the opportunity to shift the current model of care for individuals with neurodegenerative diseases such as PD.
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http://dx.doi.org/10.1093/ptj/pzaa128DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7454884PMC
September 2020

Complications Related to Esophageal Stent (Boston Scientific Wallflex vs. Merit Medical Endotek) Use in Benign and Malignant Conditions.

Cureus 2020 Mar 23;12(3):e7380. Epub 2020 Mar 23.

Public Health, Lehigh Valley Health Network, Allentown, USA.

Background In our institutions, there are two types of stents used: the Boston Scientific Wallflex (Marlborough, Massachusetts) and Merit Medical Endotek (South Jordan, Utah). So we performed this retrospective study to compare complication rates in various esophageal disorders to improve our quality of care. Methods Charts were reviewed to capture gender, indications of stent placement, stent length/diameter, age of the patient at the time of stent placement, length of hospital stay, physicians performing a procedure, and complications within 90 days of stent placement. Results A total of 67 patients (71.6% male) underwent stent placement (WallFlex 49.3% and Merit 50.8%) for malignant (68.7%) mainly esophageal obstruction by primary esophageal cancer (89.1%) and benign causes (31.3%) mainly esophageal leak (66.7%). Merit and WallFlex used in malignant conditions were 82.4% and 54.6%, respectively, and in benign conditions, they were 17.7% and 45.5%, respectively. The mean age at which endoscopy was performed was 64. Complications post Merit and WallFlex placement were 79.4% and 60.6%, respectively. Complications with malignant and benign conditions were 73.9% and 61.9%, respectively. Complications with 19, 18, and 23 mm diameters were 75.0%, 66.7%, and 69.4%, respectively. Complications with 120, 150, 100, 15, 12, 10 mm stent lengths were 84.6%, 58.3%, 58.8%, 80.0%, 75.0%, and 33.3%, respectively. Conclusion Our study showed that the Merit stent was mainly used, and the major indication of stent placement was a malignant condition. Major complications were seen when the reason for stent placement was a malignant condition, the diameter was 19 mm, the length was 120 mm, and the use of the Merit stent.
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http://dx.doi.org/10.7759/cureus.7380DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7176327PMC
March 2020

Improving Hepatitis C Screening Rates in an Ambulatory Clinic: an Observational Study.

J Gen Intern Med 2020 05 3;35(5):1610-1611. Epub 2020 Feb 3.

Division of Gastroenterology, Lehigh Valley Health Network, Allentown, PA, USA.

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http://dx.doi.org/10.1007/s11606-019-05363-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7210330PMC
May 2020

A Patient with Chronic Lymphocytic Leukemia with Pancreatic Involvement.

Case Rep Hematol 2019 16;2019:8153642. Epub 2019 Nov 16.

Department of Gastroenterology, Lehigh Valley Health Network, Allentown, PA, USA.

A 78-year-old female with a past medical history of hypertension, type 2 diabetes mellitus, and chronic lymphocytic leukemia was hospitalized for poor appetite, weight loss, and night sweats. On physical exam, there was no palpable lymphadenopathy, and her abdomen was soft and nondistended. Laboratory results showed a hemoglobin count of 13.3 g/dl, hematocrit 41.3%, white blood cell 68.4 × 103 L with lymphocytes 92.0%, total bilirubin 0.4 mg/dL, aspartate transaminase 14 U/L, and alanine transaminase 15 U/L. CT of the chest, abdomen, and pelvis showed hypodense lesions within the pancreatic body (1.4 × 1.4 cm) and medial aspect of the pancreatic head (1.2 cm) as well as mild splenomegaly (13 cm craniocaudally). She subsequently underwent endoscopic ultrasound (EUS) with fine needle aspiration (FNA) of the pancreatic mass. Flow cytometry revealed expression of CD5 and CD23, consistent with chronic lymphocytic leukemia.
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http://dx.doi.org/10.1155/2019/8153642DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6885266PMC
November 2019

The World Health Organization's Essential Diagnostics List: Diagnostics for neurologic disorders.

Neurology 2019 10;93(15):680-683

From the Department of Neurology (G.W., H.S., K.T.T.), Community and Global Neurology Program, Columbia University Irving Medical Center; Vagelos College of Physicians and Surgeons (L.G.G.), Columbia University, New York; Department of Neurology, Global Neurology Program (O.K.S.) and Department of Internal Medicine, Center for Vaccines and Virology Research (O.K.S.), Beth Israel Deaconess Medical Center, Boston, MA; Department of Internal Medicine (O.K.S.), University of Zambia School of Medicine, Lusaka; and Department of Neurological Sciences (I.J.K.), Rush University Medical Center, Chicago, IL.

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http://dx.doi.org/10.1212/WNL.0000000000008247DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7010326PMC
October 2019

Agricultural land-uses consistently exacerbate infectious disease risks in Southeast Asia.

Nat Commun 2019 09 20;10(1):4299. Epub 2019 Sep 20.

MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, School of Public Health, Imperial College London, London, UK.

Agriculture has been implicated as a potential driver of human infectious diseases. However, the generality of disease-agriculture relationships has not been systematically assessed, hindering efforts to incorporate human health considerations into land-use and development policies. Here we perform a meta-analysis with 34 eligible studies and show that people who live or work in agricultural land in Southeast Asia are on average 1.74 (CI 1.47-2.07) times as likely to be infected with a pathogen than those unexposed. Effect sizes are greatest for exposure to oil palm, rubber, and non-poultry based livestock farming and for hookworm (OR 2.42, CI 1.56-3.75), malaria (OR 2.00, CI 1.46-2.73), scrub typhus (OR 2.37, CI 1.41-3.96) and spotted fever group diseases (OR 3.91, CI 2.61-5.85). In contrast, no change in infection risk is detected for faecal-oral route diseases. Although responses vary by land-use and disease types, results suggest that agricultural land-uses exacerbate many infectious diseases in Southeast Asia.
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http://dx.doi.org/10.1038/s41467-019-12333-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6754503PMC
September 2019

Protein-based inheritance.

Semin Cell Dev Biol 2020 01 19;97:138-155. Epub 2019 Aug 19.

Microbiology Department and Biotechnology Centre, The Maharaja Sayajirao University of Baroda, Vadodara, 390002, India.

Epigenetic mechanisms of inheritance have come to occupy a prominent place in our understanding of living systems, primarily eukaryotes. There has been considerable and lively discussion of the possible evolutionary significance of transgenerational epigenetic inheritance. One particular type of epigenetic inheritance that has not figured much in general discussions is that based on conformational changes in proteins, where proteins with altered conformations can act as templates to propagate their own structure. An increasing number of such proteins - prions and prion-like - are being discovered. Phenotypes due to the structurally altered proteins are transmitted along with their structures. This review discusses the properties and implications of "classical" amyloid-forming prions, as well as the broader class of proteins with intrinsically disordered domains, which are proving to have fascinating properties that appear to play important roles in cell organisation and function, especially during stress responses.
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http://dx.doi.org/10.1016/j.semcdb.2019.07.007DOI Listing
January 2020

Initial Experience of a Community Gastroenterology Practice with Ultraslim Colonoscopy.

Cureus 2019 May 14;11(5):e4663. Epub 2019 May 14.

Gastroenterology, Lehigh Valley Health Network, Allentown, USA.

Colonoscopies are performed for cancer screening as well as for other diagnostic and therapeutic reasons. It is considered successful if cecal intubation is achieved and adequate mucosa is visualized. It is not always possible to achieve cecal intubation due to multiple reasons such as sharp angulation or fixed segments of the colon and stricture. A pediatric colonoscope (PDC) and an ultrathin colonoscope (UTC) are used as a tool to negotiate sharp angulation and the fixed segments of the colon because their small diameter allows easy movement. An ultrathin colonoscope is used at many practices as a rescue in situations where standard colonoscopes have failed. Our study highlights the use of an ultraslim scope in both rescue situations and as the initial colonoscope of choice in an ambulatory endoscopy center.
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http://dx.doi.org/10.7759/cureus.4663DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6625671PMC
May 2019

Chronic Urticaria Associated with Helicobacter pylori.

Cureus 2019 Apr 23;11(4):e4528. Epub 2019 Apr 23.

Gastroenterology, Lehigh Valley Health Network, Allentown, USA.

A 31-year-old male presented with a complaint of chronic pruritus with diffuse urticarial wheals for the past seven months. He underwent extensive workup and was found to have positive Helicobacter pylori (H. pylori) stool antigen test. He was treated with bismuth subsalicylate, metronidazole, tetracycline, and omeprazole for two weeks. Pruritus and urticarial wheals disappeared in four weeks after therapy was started.
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http://dx.doi.org/10.7759/cureus.4528DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6590730PMC
April 2019

Dual role for fungal-specific outer kinetochore proteins during cell cycle and development in .

J Cell Sci 2019 06 21;132(12). Epub 2019 Jun 21.

Biotechnology Programme, Department of Microbiology and Biotechnology Centre, The Maharaja Sayajirao University of Baroda, Vadodara 390002, Gujarat, India

The outer kinetochore DASH complex (also known as the Dam1 complex) ensures proper spindle structure and chromosome segregation. While DASH complex protein requirement diverges among different yeasts, its role in filamentous fungi has not yet been investigated. We studied the dynamics and role of middle (Mis12) and outer (Dam1 and Ask1) kinetochore proteins in the filamentous fungal pathogen, , which undergoes multiple cell cycle-linked developmental transitions. While Mis12 was constitutively present in the nucleus, Dam1 and Ask1 were recruited only during mitosis. Although Dam1 was not required for viability, loss of its function (Δ) delayed mitotic progression, resulting in impaired conidial and hyphal development. Both Dam1 and Ask1 also localised to the hyphal tips, in the form of punctae oscillating back and forth from the growing ends, suggesting that DASH complex proteins may play a non-canonical role in polarised growth during interphase, in addition to their function in nuclear segregation during mitosis. Impaired appressorial (infection structure) development and host penetration in the Δ mutant suggest that fungus-specific Dam1 complex proteins could be an attractive target for a novel anti-fungal strategy.This article has an associated First Person interview with the first author of the paper.
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http://dx.doi.org/10.1242/jcs.224147DOI Listing
June 2019

Nanoemulsion Based Vehicle for Effective Ocular Delivery of Moxifloxacin Using Experimental Design and Pharmacokinetic Study in Rabbits.

Pharmaceutics 2019 May 11;11(5). Epub 2019 May 11.

Department of Pharmaceutical Sciences, College of Clinical Pharmacy, King Faisal University, Al-Ahsa 31982, Saudi Arabia.

Nanoemulsion is one of the potential drug delivery strategies used in topical ocular therapy. The purpose of this study was to design and optimize a nanoemulsion-based system to improve therapeutic efficacy of moxifloxacin in ophthalmic delivery. Moxifloxacin nanoemulsions were prepared by testing their solubility in oil, surfactants, and cosurfactants. A pseudoternary phase diagram was constructed by titration technique and nanoemulsions were obtained with four component mixtures of Tween 80, Soluphor P, ethyl oleate and water. An experiment with simplex lattice design was conducted to assess the influence of formulation parameters in seven nanoemulsion formulations (MM1-MM7) containing moxifloxacin. Physicochemical characteristics and in vitro release of MM1-MM7 were examined and optimized formulation (MM3) was further evaluated for ex vivo permeation, antimicrobial activity, ocular irritation and stability. Drug pharmacokinetics in rabbit aqueous humor was assessed for MM3 and compared with conventional commercial eye drop formulation (control). MM3 exhibited complete drug release in 3 h by Higuchi diffusion controlled mechanism. Corneal steady state flux of MM3 (~32.01 µg/cm/h) and control (~31.53 µg/cm/h) were comparable. Ocular irritation study indicated good tolerance of MM3 and its safety for ophthalmic use. No significant changes were observed in the physicochemical properties of MM3 when stored in the refrigerator for 3 months. The greater aqueous humor concentration (; 555.73 ± 133.34 ng/mL) and delayed value (2 h) observed in MM3 suggest a reduced dosing frequency and increased therapeutic efficacy relative to control. The area under the aqueous humor concentration versus time curve () of MM3 (1859.76 ± 424.51 ng·h/mL) was ~2 fold higher (p < 0.0005) than the control, suggesting a significant improvement in aqueous humor bioavailability. Our findings suggest that optimized nanoemulsion (MM3) enhanced the therapeutic effect of moxifloxacin and can therefore be used as a safe and effective delivery vehicle for ophthalmic therapy.
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http://dx.doi.org/10.3390/pharmaceutics11050230DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6571706PMC
May 2019

Unusual Case of Obstructive Jaundice.

Cureus 2019 Feb 19;11(2):e4094. Epub 2019 Feb 19.

Gastroenterology, Lehigh Valley Health Network, Allentown, USA.

Most malignant obstructive jaundice arises from primary periampullary tumors and rarely from metastatic cancer of the head and neck. A 60-year-old male was diagnosed with obstructive jaundice due to metastatic squamous cell carcinoma of the tonsil. Only 12 cases of small bowel metastasis from the head and neck have been reported. Most of them originate from laryngeal squamous cell carcinoma, and only one case reported tonsillar cancer metastasizing to the ileum. Our case is the first one, to the best of our knowledge, to illustrate tonsillar cancer with metastasis to the duodenum causing obstructive jaundice.
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http://dx.doi.org/10.7759/cureus.4094DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6472714PMC
February 2019

Phase I Study of Aurora A Kinase Inhibitor Alisertib (MLN8237) in Combination With Selective VEGFR Inhibitor Pazopanib for Therapy of Advanced Solid Tumors.

Am J Clin Oncol 2019 05;42(5):413-420

Department of Medicine, Division of Hematology/Oncology.

Objectives: Pazopanib is a multikinase angiogenesis inhibitor. Alisertib is a highly selective inhibitor of mitotic Aurora A kinase. There is preclinical evidence that mitosis-targeting agents exhibit antiangiogenic effects. Thus, the combination of these 2 agents may have a synergistic effect on tumor vasculature. The primary objective of this study is to determine the optimal tolerated dose (OTD) for alisertib and pazopanib.

Materials And Methods: This phase 1b study evaluated the OTD of alisertib twice a day, on days 1 to 7 with pazopanib, once a day, continuously in a 21-day cycle, both taken orally. Disease response was assessed using the Response Evaluation Criteria in Solid Tumors version 1.1 every 2 cycles. OTD cohort was expanded to assure safety and perform pharmacokinetics analysis.

Results: A total of 27 patients received treatment. Seventy-seven percent of the patients had received at least 3 prior chemotherapy regimens. Dose-limiting toxicities occurred in dose level (DL) 2+ (grade 4 thrombocytopenia and grade 3 mucositis) and DL 3 (grade 3 liver transaminases elevation and grade 3 abdominal pain). The OTD was determined to be DL 2: alisertib 20 mg twice daily and pazopanib 600 mg daily. Pharmacokinetic analysis revealed that clearance of alisertib was reduced by ∼40% in the presence of pazopanib compared with clearance in the absence of pazopanib. Fourteen patients had stable disease and 2 patients had a partial response.

Conclusions: The combination of alisertib with pazopanib demonstrates manageable safety and early clinical evidence of antitumor activity in patients with advanced malignancies (NCT01639911).
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http://dx.doi.org/10.1097/COC.0000000000000543DOI Listing
May 2019

Authors' reply.

Indian J Dermatol Venereol Leprol 2019 May-Jun;85(3):314-315

Department of Dermatology, Katihar Medical College, Katihar, Bihar, India.

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http://dx.doi.org/10.4103/ijdvl.IJDVL_192_19DOI Listing
January 2020

Denture Misadventure: The Tooth About Your Colon.

Cureus 2019 Jan 15;11(1):e3890. Epub 2019 Jan 15.

Gastroenterology, Lehigh Valley Health Network, Allentown, USA.

Foreign body ingestion occurs mainly in a mentally impaired person, but rarely in healthy adults. A 48-year-old male was admitted with a recurrence of previously diagnosed right knee septic arthritis and accidentally ingested his dental bridge which was removed from a proximal ascending colon with a colonoscopy.
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http://dx.doi.org/10.7759/cureus.3890DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6424550PMC
January 2019

Proniosomal gel for transdermal delivery of lornoxicam: optimization using factorial design and in vivo evaluation in rats.

Daru 2019 Jun 30;27(1):59-70. Epub 2019 Jan 30.

Department of Pharmaceutical Sciences, College of Clinical Pharmacy, King Faisal University, Al-Ahsa, Saudi Arabia.

Objective: Clinical utility of lornoxicam in oral therapy is primarily restricted by the low solubility and gastric adverse effects. This study evaluated the prospective of optimized proniosomal gel to improve the clinical efficacy of lornoxicam and compare with oral therapy.

Methods: Proniosomes were formulated by coacervation phase separation technique using span 60, lecithin and cholesterol. A four-factor three-level Box-Behnken design was used to evaluate the effect of amount of four independent variables; span 60 (X), cholesterol (X), lecithin (X) and lornoxicam (X) on response variables; vesicle size (Y), entrapment efficiency (Y) and transdermal flux (Y). The selected proniosomal gel (F19) was characterized, and evaluated for the transdermal efficacy by ex vivo and in vivo experiments.

Results: Optimization study signifies that amount of formulation components (span 60, cholesterol, lecithin and lornoxicam) influence the vesicle size, entrapment efficiency and/or transdermal flux. Optimized formulation F19 exhibited nano size with high entrapment efficiency, adequate zeta potential, greater transdermal flux and better stability (at refrigerated conditions). The entrapment of lornoxicam in the bilayers of proniosome vesicles was confirmed by differential scanning calorimeter. Release profile of F19 was distinct (p < 0.001) from gel prepared using hydroxypropyl methylcellulose (control) and displayed steady lornoxicam release by Fickian diffusion. Transdermal administration of F19 significantly inhibited the carrageenan induced hind-paw edema in rats as compared to oral lornoxicam group.

Conclusions: The data observed in this study demonstrated that the developed proniosomal gel (F19) improved the clinical efficacy of lornoxicam as compared to oral therapy. Graphical Abstract Proniosomal gel for transdermal delivery of lornoxicam: optimization using factorial design and in vivo evaluation in rats.
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http://dx.doi.org/10.1007/s40199-019-00242-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6593013PMC
June 2019

A feasibility study of breast cancer genetic risk assessment in a federally qualified health center.

Cancer 2018 09 15;124(18):3733-3741. Epub 2018 Oct 15.

Institute for Health Research and Policy, School of Public Health, University of Illinois at Chicago, Chicago, Illinois.

Background: The US Preventive Services Task Force (USPSTF) endorses routine screening for genetic risk of breast and/or ovarian cancer as a component of primary health care. Implementation of this recommendation may prove challenging, especially in clinics serving disadvantaged communities.

Methods: The authors tested the feasibility of implementing the USPSTF mandate at a federally qualified health center (FQHC) to identify women who were eligible for genetic counseling (GC). A 12-month usual-care phase was followed by a 12-month intervention phase, during which time cancer genetic risk assessment (CGRA) was systematically performed for all women aged 25 to 69 years who presented for an annual examination. Women who were eligible for GC were recruited to participate in the study.

Results: After initiating CGRA, 112 women who were eligible for GC consented to study participation, and 56% of them received a referral for GC from their primary care physician. A subgroup of 50 participants were seen by the same primary care physician during both the usual-care and intervention phases. None of these patients was referred for GC during usual care, compared with 64% after the initiation of CGRA (P < .001). Only 16% of referred participants attended a GC session.

Conclusions: Implementing USPSTF recommendations for CGRA as a standard component of primary health care in FQHCs is feasible and improves referral of minority women for GC, but more work is needed to understand the beliefs and barriers that prevent many underserved women from accessing cancer genetic services.
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http://dx.doi.org/10.1002/cncr.31635DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6214782PMC
September 2018

Transepidermal elimination: Historical evolution, pathogenesis and nosology.

Indian J Dermatol Venereol Leprol 2018 Nov-Dec;84(6):753-757

Department of Dermatology, Katihar Medical College, Katihar, Bihar, India.

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http://dx.doi.org/10.4103/ijdvl.IJDVL_396_17DOI Listing
January 2019

[Homeopathic Medicine Reduces Pain and Hemarthrosis in Moderate and Severe Hemophilia: A Multicentric Study].

Complement Med Res 2018 29;25(5):306-312. Epub 2018 May 29.

Background: Hemarthrosis is a common clinical presentation of patients with severe and moderately severe hemophilia. Severe pain, swelling, and loss of function involving knee, ankle, elbow, and shoulder joints are commonly seen. In India, except for paracetamol and some non-steroidal anti-inflammatory drugs (NSAIDs), opiate analgesics are not easily available even in the mainstay of treatment; i.e., factor concentrates are also not available regularly. Hence, there is an unmet need for exploring alternative management strategies in this condition in India.

Objective: To assess the effect of homeopathic medicines on pain and acute hemarthrosis in hemophilia when factor concentrates are not available and paracetamol in adequate doses proves inadequate.

Patients: 343 patients with hemophilia (PWH) from Nashik, Mumbai, and Surat presenting with hemarthrosis were prescribed homeopathic medicines in addition to paracetamol and RICE (rest, immobilization, cold application, and elevation). They were assessed using standard techniques.

Results: 1,679 episodes of hemarthrosis in major joints were encountered between December 2007 and March 2014, in 343 patients. In 1,580 of the 1,679 hemarthrosis episodes (94.1%), bleeding/inflammation was arrested and pain relieved with homeopathic medication. Additional factor concentrate was required in 99 patients (4.48%). The mean pain score improved from 6.88 ± 2.118 to 1.5 ± 0.34 over 6-24 h following the homeopathic medicines (p < 0.0001). The swellings were also substantially reduced (p < 0.001). The number of joint bleeds per month was reduced significantly under the influence of therapy (p < 0.0001), showing the long-term disease-modifying effect of the treatment.

Conclusion: Homeopathic medicines without factor concentrates appeared to reduce bleeding and pain in PWH presenting with hemarthrosis and could have influenced the long-term frequency of bleeding.
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http://dx.doi.org/10.1159/000486557DOI Listing
September 2019

Teaching the relationship between health and climate change: a systematic scoping review protocol.

BMJ Open 2018 05 20;8(5):e020330. Epub 2018 May 20.

Global eHealth Unit, Department of Primary Care and Public Health, School of Public Health, Imperial College London, London, UK.

Introduction: The observed and projected impacts of climate change on human health are significant. While climate change has gathered global momentum and is taught frequently, the extent to which the relationships between climate change and health are taught remains uncertain. Education provides an opportunity to create public engagement on these issues, but the extent to which historical implementation of climate health education could be leveraged is not well understood. To address this gap, we propose to conduct a scoping review of all forms of teaching that have been used to illustrate the health effects of climate change between 2005 and 2017, coinciding with a turning point in the public health and climate change agendas following the 2005 Group of 7/8 (G7/8) Summit.

Methods And Analysis: Using Arksey/O'Malley's and Levac's methodological framework, MEDLINE/PubMed, Embase, Scopus, Education Resource Information Centre, Web of Science, Global Health, Health Management Information Consortium, Georef, Ebsco and PROSPERO will be systematically searched. Predetermined inclusion and exclusion criteria will be applied by two independent reviewers to determine study eligibility. Studies published in English and after 2005 only will be examined. Following selection of studies, data will be extracted and analysed.

Ethics And Dissemination: No ethical approval is required as exclusively secondary data will be used. Our findings will be communicated to the European Institute of Innovation & Technology Health-Knowledge and Innovation Communities to assist in the development of a FutureLearn Massive Open Online Course on the health effects of climate change.
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http://dx.doi.org/10.1136/bmjopen-2017-020330DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5961595PMC
May 2018

Updates on immunotherapy for colorectal cancer.

J Gastrointest Oncol 2018 Feb;9(1):160-169

Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL, USA.

Despite significant advances in standard of care therapies, the 5-year survival rate for metastatic colorectal cancer (CRC) remains around 12%. Immunotherapy has not provided the stellar advances in colorectal cancer that has been seen in other malignancies. Immunotherapy appears to play a pivotal role in microsatellite unstable CRC tumors where the response rates are profound. These results have led to FDA approval of pembrolizumab for MSI-H CRC tumors. Additional research into several new immune agents including IDO inhibitors, vaccine therapy and combinatorial agents are being evaluated for CRC. This review will provide an overview of the approaches currently being investigated.
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http://dx.doi.org/10.21037/jgo.2018.01.17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5848033PMC
February 2018

Triple Pancreatic Walled-off Fluid Collections Treated Simultaneously with Endoscopic Transmural Drainage.

Cureus 2018 Jan 9;10(1):e2047. Epub 2018 Jan 9.

Gastroenterology, Lehigh valley health network.

Pancreatic pseudocysts and walled-off pancreatic necrosis arise as a complication of pancreatitis. Multiple fluid collections are seen in 5-20% of the patients who have walled-off peripancreatic fluid collections. There is a paucity of data regarding the role of endoscopic transmural drainage in the management of multiple pancreatic fluid collections. In this case report, we present the case of a 72-year-old male with three walled-off pancreatic fluid collections in the setting of acute necrotizing pancreatitis. The patient underwent simultaneous endoscopic ultrasound-assisted cyst gastrostomy and cyst duodenostomy and aggressive irrigation without index endoscopic necrosectomy of the three peripancreatic fluid collections. Significant improvement in the size of the fluid collections was seen on the computed tomography scan, as well as a remarkable immediate clinical improvement after 24 hours of the endoscopic intervention.
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http://dx.doi.org/10.7759/cureus.2047DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5844594PMC
January 2018

A study of clinicopathological characteristics of thyroid carcinoma at a Tertiary Care Center.

J Cancer Res Ther 2018 Jan-Mar;14(2):357-360

Department of Pathology, Mahavir Cancer Sansthan, Patna, Bihar, India.

Context: To share clinicopathological data of thyroid carcinoma from a high volume Tertiary Care Centre in East India.

Aim: To share the epidemiology and clinicopathological presentation of thyroid cancer at a high volume Tertiary Care Center in East India.

Settings And Design: Retrospective observational study.

Subjects And Methods: Forty-two consecutive patients of thyroid neoplasm diagnosed by fine needle aspiration cytology (FNAC) and primarily underwent surgical treatment from July 2005 to June 2012 were included. Retrospective data analyses of patient's records were done.

Statistical Analysis Used: The statistical analysis was performed using Epi Info version 3.5.3.

Results: Forty-two patients underwent surgery for thyroid neoplasm. Median age of diagnosis was 39 years. It was 6 times more common in females (female:male - 6:1). Papillary carcinoma consists of 63.15%, follicular carcinoma consists of 23.68%, and medullary carcinoma and anaplastic carcinoma each consist of 5.26% of malignant cases. Out of them, lymph node metastases were seen in 17 patients (44.73%). FNAC shows positive predictive value of 89.74%.

Conclusions: In our study, differentiated thyroid cancers were found to be more common in younger age group. Cervical lymph node metastases occur in a large number of patients. Central compartment lymph node dissection with exploration of lateral neck and modified neck dissection whenever needed is helpful in all cases of thyroid carcinoma for proper pathological staging. FNAC is rapid and efficient procedure with high positive predictive value in diagnosing thyroid neoplastic lesions.
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http://dx.doi.org/10.4103/0973-1482.180611DOI Listing
August 2018