208 Kevin Ln Ste 101
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Tolerable Levels of Nonclinical Vehicles and Formulations Used in Studies by Multiple Routes in Multiple Species With Notes on Methods to Improve Utility. - International journal of toxicology
Formulation of nonclinical evaluations is a challenge, with the fundamental need to achieve multiples of the clinical exposure complicated by differences in species and routes of administration-specific tolerances, depending on concentrations, volumes, dosing regimen, duration of each administration, and study duration. Current practice to approach these differences is based on individual experience and scattered literature with no comprehensive data source (the most notable exception being our 2006 publication on this same subject). Lack of formulation tolerance data results in excessive animal use, unplanned delays in the evaluation and development of drugs, and vehicle-dependent results. A consulting firm, a chemical company, and 4 contract research organizations conducted a rigorous data mining operation of vehicle data from studies dating from 1991 to 2015, enhancing the data from this author's 2006 publication (3 of the six 2015 contributors were also 2006 contributors). Additional data were found in the published literature. The results identified 108 single-component vehicles (and 305 combination formulations) used in more than 1,040 studies across multiple species (dog, primate, rat, mouse, rabbit, guinea pig, minipig, pig, chick embryo, and cat) by multiple routes for a wide range of study durations. The tabulated data include maximum tolerated use levels by species, route, duration of study, dose-limiting toxicity where reported, review of the available literature on each vehicle, guidance on syringe selection, volume and pH limits by route with basic guidance on nonclinical formulation development, and guidance on factors to be considered in nonclinical route selection.Â© The Author(s) 2016.
Adolescent sleep and cellular phone use: recent trends and implications for research. - Health services insights
Adolescent sleep needs range from 8.5-10 hours per night, with older adolescents requiring less sleep than younger adolescents. On average, however, American adolescents receive between 7.5-8.5 hours of sleep per night, with many sleeping fewer than 6.5 hours on school nights. Cellular phone use is emerging as an important factor that interferes with both sleep quality and quantity, particularly as smartphones become more widely available to teens. This review paper has three objectives. First, we will describe adolescent sleep patterns and the effects of sleep deprivation on adolescent physical and mental health. Second, we will describe current trends in technology use among adolescents, making associations to how technology impacts sleep. Lastly, we will discuss some of the methodological barriers of conducting sleep and technology research with adolescents and young adults and offer suggestions for overcoming those barriers. We will also discuss implications for healthcare providers.
Phomopsis bougainvilleicola prepatellar bursitis in a renal transplant recipient. - Journal of clinical microbiology
Prepatellar bursitis is typically a monomicrobial bacterial infection. A fungal cause is rarely identified. We describe a 61-year-old man who had received a renal transplant 21 months prior to presentation whose synovial fluid and surgical specimens grew Phomopsis bougainvilleicola, a pycnidial coelomycete.
The major genetic determinants of HIV-1 control affect HLA class I peptide presentation. - Science (New York, N.Y.)
Infectious and inflammatory diseases have repeatedly shown strong genetic associations within the major histocompatibility complex (MHC); however, the basis for these associations remains elusive. To define host genetic effects on the outcome of a chronic viral infection, we performed genome-wide association analysis in a multiethnic cohort of HIV-1 controllers and progressors, and we analyzed the effects of individual amino acids within the classical human leukocyte antigen (HLA) proteins. We identified >300 genome-wide significant single-nucleotide polymorphisms (SNPs) within the MHC and none elsewhere. Specific amino acids in the HLA-B peptide binding groove, as well as an independent HLA-C effect, explain the SNP associations and reconcile both protective and risk HLA alleles. These results implicate the nature of the HLA-viral peptide interaction as the major factor modulating durable control of HIV infection.
A retrospective evaluation of completion rates, total cost, and adverse effects for treatment of latent tuberculosis infection in a public health clinic in central massachusetts. - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Completion rates, total cost, and adverse effects were compared for patients in central Massachusetts treated for latent tuberculosis infection with 9 months of isoniazid or 4 months of rifampin. Although the adverse effects were similar between the 2 groups, 4 months of rifampin was associated with significantly better completion rates and less hepatotoxicity yet higher total cost.
Posaconazole as salvage therapy in patients with invasive fungal infections after solid organ transplant. - Transplantation
The incidence of invasive fungal infections (IFIs) in solid organ transplant (SOT) recipients has increased during the past 20 years and is associated with significant morbidity and mortality. In this post hoc analysis of a large, open-label, multicenter study, we evaluated efficacy and safety of posaconazole, a new extended-spectrum triazole, as salvage therapy for IFIs in SOT recipients.Twenty-three SOT recipients with proven or probable IFI and evidence of disease refractory to, or intolerant of, standard antifungal therapies received posaconazole oral suspension (40 mg/mL) 800 mg daily in divided doses. An independent, blinded data-review committee assessed patient diagnosis and outcome.Complete or partial response was documented in 13 of 23 (57%) SOT recipients with proven or probable IFIs, including 1 of 2 (50%) refractory patients, 5 of 8 (63%) intolerant to prior therapy, and 7 of 13 (54%) who were both. Successes by type of IFI included 7 of 12 with invasive aspergillosis, 2 of 2 with invasive fusariosis, 1 of 1 with cryptococcosis, and 1 of 2 with zygomycosis. Treatment-related adverse events (TRAEs) were reported in 12 of 23 patients. Severe TRAEs occurred in 4 of 23 patients including increased levels of cyclosporine or tacrolimus requiring immunosuppressive dose adjustments in three patients and in one, termination of posaconazole. Severe TRAEs associated with renal and liver toxicities were uncommon.Posaconazole was well tolerated and effective against IFIs including invasive aspergillosis, zygomycosis, fusariosis, and cryptococcosis in SOT recipients intolerant of or failing other antifungal therapies. Calcineurin inhibitor levels should be closely monitored in patients treated concomitantly with posaconazole to avoid toxicity from drug interaction.
Financial disclosures of scientific papers presented at the 2003 RSNA Annual Meeting: association with reporting of non-Food and Drug Administration-approved uses of industry products. - Radiology
To retrospectively characterize the extent and nature of financial relationships with industry that are disclosed in the abstracts of scientific papers presented at the 2003 Radiological Society of North America (RSNA) Annual Meeting and to retrospectively assess whether the presence of relationships between researchers and industry was associated with a discussion on the use of products or devices that are not yet approved by the U.S. Food and Drug Administration (FDA).Printed abstracts of scientific papers published in the 2003 Radiological Society of North America Scientific Assembly and Annual Meeting Program were classified according to the number and type of financial relationships disclosed. Also recorded was whether the abstracts discussed non-FDA-approved use of a product. Abstracts with and those without disclosures were then compared by using the Fisher exact test with respect to the percentage of abstracts that reported non-FDA-approved use.Of the 1549 published abstracts, 271 (17%) disclosed at least one author with financial ties to a company whose products or services were reported. The most common disclosures were for authors who were employees (39%), corporate grant recipients (34%), corporate consultants (23%), or shareholders (18%) of the corporation whose product was studied. A total of 87 (32%) of 271 abstracts with disclosed corporate relationships discussed non-FDA-approved use of a commercial product compared with 197 (15%) of 1278 abstracts with no disclosed tie to industry (P<.001).RSNA abstracts in which authors disclosed corporate financial relationships were twice as likely as those without such disclosures to discuss non-FDA-approved use of a commercial product. This raises the possibility that corporate relationships may influence radiology research.Copyright (c) RSNA, 2006.
Effects of atorvastatin versus other statins on fasting and postprandial C-reactive protein and lipoprotein-associated phospholipase A2 in patients with coronary heart disease versus control subjects. - The American journal of cardiology
The effects of atorvastatin (40 mg/day) versus placebo on fasting and postprandial plasma levels of high-sensitivity C-reactive protein (hs-CRP) and lipoprotein-associated phospholipase A2 (Lp-PLA2) were examined over 36 weeks in 84 patients who had coronary heart disease and low-density lipoprotein cholesterol levels >130 mg/dl and compared directly with the effects of fluvastatin, lovastatin, pravastatin, and simvastatin. Results were also compared with those obtained in age- and gender-matched control subjects (n = 84). Feeding increased median hs-CRP levels by 2% in patients (p = NS) and 22% in controls (p <0.01) and increased mean Lp-PLA2 values by 9% in patients (p = NS) but decreased values by 21% in controls (p <0.0001). Patients had 51% higher median hs-CRP values and 29% higher mean Lp-PLA2 values than did controls (p <0.05 for hs-CRP and Lp-PLA2) in the fasting state; however, Lp-PLA2 values were 62% higher (p <0.0001) in the fed state in patients compared with controls. Atorvastatin decreased median hs-CRP levels by 32% (p <0.01) and mean Lp-PLA2 values by 26% in patients (p <0.0001), with similar decreases in the fed state, and none of the other statins had any significant effect on these parameters. Change in Lp-PLA2 was significantly related to change in low-density lipoprotein cholesterol (p <0.01), with no significant relations with change in hs-CRP. Our data indicate greater differences in patients with coronary heart disease compared with controls in Lp-PLA2 in the fed state than in the fasting state and that atorvastatin is more effective than fluvastatin, lovastatin, pravastatin, or simvastatin for decreasing not only low-density lipoprotein cholesterol but also hs-CRP and Lp-PLA2.
Comparisons of effects of statins (atorvastatin, fluvastatin, lovastatin, pravastatin, and simvastatin) on fasting and postprandial lipoproteins in patients with coronary heart disease versus control subjects. - The American journal of cardiology
The effects of atorvastatin at 20, 40, and 80 mg/day on plasma lipoprotein subspecies were examined in a randomized, placebo-controlled fashion over 36 weeks in 97 patients with coronary heart disease (CHD) with low-density lipoprotein (LDL) cholesterol levels of >130 mg/dl and compared directly with the effects of fluvastatin (n = 28), pravastatin (n = 22), lovastatin (n = 24), and simvastatin (n = 25). The effects of placebo and 40 mg/day of each statin were also examined in subjects with CHD with subjects in the fasting state and in the fed state 4 hours after a meal rich in saturated fat and cholesterol and compared with results in age- and gender-matched control subjects. At all doses tested in the fasting and fed states, atorvastatin was significantly (p <0.01) more effective in lowering LDL cholesterol and non-high-density lipoprotein (HDL) cholesterol than all other statins, and significantly (p <0.05) more effective than all statins, except for simvastatin, in lowering triglyceride and remnant lipoprotein (RLP) cholesterol. At 40 mg/day in the fasting state, atorvastatin was significantly (p <0.01) more effective than all statins, except for lovastatin and simvastatin, in lowering cholesterol levels in small LDL, and was significantly (p <0.05) more effective than all statins, except for simvastatin, in increasing cholesterol in large HDL and in lowering LDL particle numbers. Our data indicate that atorvastatin was the most effective statin tested in lowering cholesterol in LDL, non-HDL, and RLP in the fasting and fed states, and getting patients with CHD to established goals, with fluvastatin, pravastatin, lovastatin, and simvastatin having about 33%, 50%, 60%, and 85% of the efficacy of atorvastatin, respectively, at the same dose in the same patients.
A history of the Robert M. Zollinger Chair of Surgery. - American journal of surgery
The senior director of medical center development and alumni affairs at the Ohio State University and a development officer at the Ohio State University Office of Medical Center and Health Sciences Development describe the origins of the endowed Robert M. Zollinger Chair of Surgery and the recipients of the professorship.
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