Archival tumor samples represent a potential rich resource of annotated specimens for translation... more Archival tumor samples represent a potential rich resource of annotated specimens for translational genomics research. However, standard variant calling approaches require a matched normal sample from the same individual, which is often not available in the retrospective setting, making it difficult to distinguish between true somatic variants and germline variants that are private to the individual. Archival sections often contain adjacent normal tissue, but this normal tissue can include infiltrating tumor cells. Comparative somatic variant callers are designed to exclude variants present in the normal sample, so a novel approach is required to leverage sequencing of adjacent normal tissue for somatic variant calling. Here we present LumosVar 2.0, a software package designed to jointly analyze multiple samples from the same patient. The approach is based on the concept that the allelic fraction of somatic variants, but not germline variants, would be reduced in samples with low tu...
Glioblastoma multiforme is the most malignant form of brain tumor. Despite treatment including su... more Glioblastoma multiforme is the most malignant form of brain tumor. Despite treatment including surgical resection, adjuvant chemotherapy, and radiation, these tumors typically recur. The recurrent tumor is often resistant to further therapy with the same agent, suggesting that the surviving cells that repopulate the tumor mass have an intrinsic genetic advantage. We previously demonstrated that cells selected for resistance to 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU) are near-diploid, with over-representation of part or all of chromosomes 7 and 22. While cells from untreated gliomas often have over-representation of chromosome 7, chromosome 22 is typically under-represented. We have analyzed cells from primary and recurrent tumors from the same patient before and after in vitro selection for resistance to clinically relevant doses of BCNU. Karyotypic analyses were done to demonstrate the genetic makeup of these cells, and fluorescent in situ hybridization analyses have defined th...
TEXILA INTERNATIONAL JOURNAL OF CLINICAL RESEARCH, 2017
Clinical trials are a key research tool for advancing medical knowledge and patient care. They ul... more Clinical trials are a key research tool for advancing medical knowledge and patient care. They ultimately gear towards ameliorating and improving diagnosis and treatment of all diseases by introducing novel interventions and therapies. Essential to conducting a clinical trial is randomizing the proper study population through recruiting eligible participants based on inclusion and exclusion criteria, and ensuring study completion and adherence of study patient participation. Although these may seem simplistic, patient recruitment, retention and adherence are the most difficult challenges in clinical trials. While patient recruitment is one of the key elements to study completion, over 80% of clinical trials shockingly do not finish on time. Devising a potential strategy is vital in overcoming recruitment barriers; however, it is very costly and cumbersome. Lambda Health, LLC is in the process of creating a clinical research tool that can interface with EMR, in hopes of increasing patient retention through proper site selection, and setting reminders to patients about medication dosing, diary documentation, study procedures and visits scheduling. Ideally through implementing this tool into clinical trials, less effort and money will be spent on recruitment and the rates of adherence and retention will increase.
OBJECTIVE: To study clinical and electrophysiologic outcomes of patients undergoing peripheral ne... more OBJECTIVE: To study clinical and electrophysiologic outcomes of patients undergoing peripheral nerve decompression for painful diabetic neuropathies. BACKGROUND: Despite extensive research there is no clear understanding of the pathophysiology of diabetic neuropathy. One approach that has emerged is the concept of decompressing nerves that are commonly entrapped in diabetes. Unfortunately there is no consensus on how entrapped nerves can be identified as nerve conduction studies (NCS) often do not detect abnormalities or may be difficult to reliably obtain. Anecdotally many patients report improved pain and sensibility following decompression surgeries however prospective studies evaluating changes in symptoms, and electrophysiology have been limited. DESIGN/METHODS: 10 patients with painful diabetic neuropathy who chose to undergo peripheral nerve decompression were enrolled. Patients were given a HR-QOL, PGI, NPS, and BPI questionnaires at screening to evaluate initial pain and se...
OBJECTIVE: To develop a registry of Acthar-treated myositis patients and to determine the clinica... more OBJECTIVE: To develop a registry of Acthar-treated myositis patients and to determine the clinical and pathologic features that predict outcomes. The goal of this registry is to link clinical information with dosing, safety and clinical response to Acthar and to determine if sub-types of myositis, classified by muscle biopsy pathology, predict response to Acthar. BACKGROUND: Despite a wide variety of medications used to treat the inflammatory myopathies (e.g. glucocorticoids, immunosuppressive agents, intravenous gammaglobulin, etc), the only FDA-approved medications for polymyositis (PM) and dermatomyositis (DM) are glucocorticoids and Acthar gel, a highly purified extract of porcine pituitary that contains adrenocorticotropic hormone (ACTH). Besides ACTH promoting the release of endogenous glucocorticoids, it binds to melanocortin (MSH) receptors leading to anti-inflammatory effects distinct from steroidogenesis. Despite the FDA indication, Acthar, has not been adequately studied ...
Worldwide, nutritional supplements have been utilized prophylactically, as well as to assist and ... more Worldwide, nutritional supplements have been utilized prophylactically, as well as to assist and improve specific diseases and illnesses for decades. Since the U.S. Food and Drug Administration (FDA) does not regulate dietary supplements in the same way that it regulates medicine, dietary supplements can be sold without FDA approval. Neuro-V, a product that was originally developed to improve nerve regeneration in people who suffer from Neuropathy, has a myriad of health benefits that can also protect against oxidative stress as well as improve energy production. The antioxidants and amino acids that were meticulously chosen in Neuro-V (Acetyl L-Carnitine, Alpha Lipoic Acid, N-Acetyl L-Cysteine, Cyanocobalamin (B-12), Pyridoxine HCL (B-6), Folic Acid (B-9) and Grape Seed Extract) have individually been reported and studied to reduce neuropathic pain as well as prevent mitochondrial damage. Although, there are a variety of treatments that essentially provide symptomatic relief for pa...
Increased production of reactive oxygen species (ROS) in mitochondria, play an important role in ... more Increased production of reactive oxygen species (ROS) in mitochondria, play an important role in the cardiovascular system. Furthermore, oxidative metabolism of mitochondria comprised of biophoton emissions, are linked to ROS and oxidative stress. In this review we investigated the association between the ability of ClearViewTM system (ClearView) to indicate the presence or absence of cardiovascular disease through mitochondria respiration as depicted through biophotonic emission. One hundred and ninety-five out of the three hundred and fifty-three human subjects enrolled in this prospective, single site study had at least one cardiovascular related diagnosis. Measurements with ClearView consisted of scanning all 10 fingers twice. Images were captured through the ClearView software and analyzed to produce a scale that indicates the presence or absence of cardiovascular disease. The association of ClearView's ability to indicate the presence or absence of cardiovascular disease w...
To assess the usefulness of skin biopsy in the assessment of patients with suspeted small fiber n... more To assess the usefulness of skin biopsy in the assessment of patients with suspeted small fiber neuropathy (SFN). Retrospective chart review of patients with sensory symptoms or findings restricted to small nerve fibers and normal nerve conduction studies (NCS) seen in a subspecialty neuromuscular private practice. Assessments were made on 145 patients. Skin biopsy was abnormal in at least one site in 86 patients (59%). There was no significant difference between patients with normal or abnormal skin biopsies with respect to age, gender, or duration of symptoms. Compared to patients with normal skin biopsies, patients with confirmed SFN were significantly more likely to have pain and were more than twice as likely to respond to standard neuropathic pain medications. Skin biopsy is useful in the diagnosis and management of patients with otherwise unexplained sensory symptoms or findings.
BMC complementary and alternative medicine, Jan 16, 2006
Flavonoid-rich extracts from the mature roots of Scutellaria baicalensis have been shown to exhib... more Flavonoid-rich extracts from the mature roots of Scutellaria baicalensis have been shown to exhibit antiproliferative effects on various cancer cell lines. We assessed the ability of an ethanolic extract of S. baicalensis root to inhibit the proliferation of malignant glioma cells. Cell lines derived from primary and recurrent brain tumors from the same patient and cells selected for resistance to the chemotherapeutic agent 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU) were used to identify antiproliferative effects of this extract when used alone and in conjunction with BCNU. Results indicated that Scutellaria baicalensis not only inhibits cellular growth in recurrent and drug resistant brain tumor cell lines, but also demonstrates an increased inhibitory effect when used in conjunction with BCNU. The results of this study support the efficacy of S. baicalensis as an anticancer agent for glioblastomas multiforme and a potential adjuvant treatment to current chemotherapeutic agents us...
Objectives. To determine if therapy with pioglitazone HCl and tretinoin could slow disease progre... more Objectives. To determine if therapy with pioglitazone HCl and tretinoin could slow disease progression in patients with ALS. Levels of tau and pNFH in the cerebrospinal fluid were measured to see if they could serve as prognostic indicators.Methods. 27 subjects on stable doses of riluzole were enrolled. Subjects were randomized to receive pioglitazone 30 mg/d and tretinoin 10 mg/BID for six months or two matching placebos. ALSFRS-R scores were followed monthly. At baseline and at the final visit, lumbar punctures (LPs) were performed to measure cerebrospinal fluid (CSF) biomarker levels.Results. Subjects treated with tretinoin, pioglitazone, and riluzole had an average rate of decline on the ALSFRS-R scale of −1.02 points per month; subjects treated with placebo and riluzole had a rate of decline of-.86(P=.18). Over six months of therapy, CSF tau levels decreased in subjects randomized to active treatment and increased in subjects on placebo. Further higher levels of pNF-H at baseli...
Archival tumor samples represent a potential rich resource of annotated specimens for translation... more Archival tumor samples represent a potential rich resource of annotated specimens for translational genomics research. However, standard variant calling approaches require a matched normal sample from the same individual, which is often not available in the retrospective setting, making it difficult to distinguish between true somatic variants and germline variants that are private to the individual. Archival sections often contain adjacent normal tissue, but this normal tissue can include infiltrating tumor cells. Comparative somatic variant callers are designed to exclude variants present in the normal sample, so a novel approach is required to leverage sequencing of adjacent normal tissue for somatic variant calling. Here we present LumosVar 2.0, a software package designed to jointly analyze multiple samples from the same patient. The approach is based on the concept that the allelic fraction of somatic variants, but not germline variants, would be reduced in samples with low tu...
Glioblastoma multiforme is the most malignant form of brain tumor. Despite treatment including su... more Glioblastoma multiforme is the most malignant form of brain tumor. Despite treatment including surgical resection, adjuvant chemotherapy, and radiation, these tumors typically recur. The recurrent tumor is often resistant to further therapy with the same agent, suggesting that the surviving cells that repopulate the tumor mass have an intrinsic genetic advantage. We previously demonstrated that cells selected for resistance to 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU) are near-diploid, with over-representation of part or all of chromosomes 7 and 22. While cells from untreated gliomas often have over-representation of chromosome 7, chromosome 22 is typically under-represented. We have analyzed cells from primary and recurrent tumors from the same patient before and after in vitro selection for resistance to clinically relevant doses of BCNU. Karyotypic analyses were done to demonstrate the genetic makeup of these cells, and fluorescent in situ hybridization analyses have defined th...
TEXILA INTERNATIONAL JOURNAL OF CLINICAL RESEARCH, 2017
Clinical trials are a key research tool for advancing medical knowledge and patient care. They ul... more Clinical trials are a key research tool for advancing medical knowledge and patient care. They ultimately gear towards ameliorating and improving diagnosis and treatment of all diseases by introducing novel interventions and therapies. Essential to conducting a clinical trial is randomizing the proper study population through recruiting eligible participants based on inclusion and exclusion criteria, and ensuring study completion and adherence of study patient participation. Although these may seem simplistic, patient recruitment, retention and adherence are the most difficult challenges in clinical trials. While patient recruitment is one of the key elements to study completion, over 80% of clinical trials shockingly do not finish on time. Devising a potential strategy is vital in overcoming recruitment barriers; however, it is very costly and cumbersome. Lambda Health, LLC is in the process of creating a clinical research tool that can interface with EMR, in hopes of increasing patient retention through proper site selection, and setting reminders to patients about medication dosing, diary documentation, study procedures and visits scheduling. Ideally through implementing this tool into clinical trials, less effort and money will be spent on recruitment and the rates of adherence and retention will increase.
OBJECTIVE: To study clinical and electrophysiologic outcomes of patients undergoing peripheral ne... more OBJECTIVE: To study clinical and electrophysiologic outcomes of patients undergoing peripheral nerve decompression for painful diabetic neuropathies. BACKGROUND: Despite extensive research there is no clear understanding of the pathophysiology of diabetic neuropathy. One approach that has emerged is the concept of decompressing nerves that are commonly entrapped in diabetes. Unfortunately there is no consensus on how entrapped nerves can be identified as nerve conduction studies (NCS) often do not detect abnormalities or may be difficult to reliably obtain. Anecdotally many patients report improved pain and sensibility following decompression surgeries however prospective studies evaluating changes in symptoms, and electrophysiology have been limited. DESIGN/METHODS: 10 patients with painful diabetic neuropathy who chose to undergo peripheral nerve decompression were enrolled. Patients were given a HR-QOL, PGI, NPS, and BPI questionnaires at screening to evaluate initial pain and se...
OBJECTIVE: To develop a registry of Acthar-treated myositis patients and to determine the clinica... more OBJECTIVE: To develop a registry of Acthar-treated myositis patients and to determine the clinical and pathologic features that predict outcomes. The goal of this registry is to link clinical information with dosing, safety and clinical response to Acthar and to determine if sub-types of myositis, classified by muscle biopsy pathology, predict response to Acthar. BACKGROUND: Despite a wide variety of medications used to treat the inflammatory myopathies (e.g. glucocorticoids, immunosuppressive agents, intravenous gammaglobulin, etc), the only FDA-approved medications for polymyositis (PM) and dermatomyositis (DM) are glucocorticoids and Acthar gel, a highly purified extract of porcine pituitary that contains adrenocorticotropic hormone (ACTH). Besides ACTH promoting the release of endogenous glucocorticoids, it binds to melanocortin (MSH) receptors leading to anti-inflammatory effects distinct from steroidogenesis. Despite the FDA indication, Acthar, has not been adequately studied ...
Worldwide, nutritional supplements have been utilized prophylactically, as well as to assist and ... more Worldwide, nutritional supplements have been utilized prophylactically, as well as to assist and improve specific diseases and illnesses for decades. Since the U.S. Food and Drug Administration (FDA) does not regulate dietary supplements in the same way that it regulates medicine, dietary supplements can be sold without FDA approval. Neuro-V, a product that was originally developed to improve nerve regeneration in people who suffer from Neuropathy, has a myriad of health benefits that can also protect against oxidative stress as well as improve energy production. The antioxidants and amino acids that were meticulously chosen in Neuro-V (Acetyl L-Carnitine, Alpha Lipoic Acid, N-Acetyl L-Cysteine, Cyanocobalamin (B-12), Pyridoxine HCL (B-6), Folic Acid (B-9) and Grape Seed Extract) have individually been reported and studied to reduce neuropathic pain as well as prevent mitochondrial damage. Although, there are a variety of treatments that essentially provide symptomatic relief for pa...
Increased production of reactive oxygen species (ROS) in mitochondria, play an important role in ... more Increased production of reactive oxygen species (ROS) in mitochondria, play an important role in the cardiovascular system. Furthermore, oxidative metabolism of mitochondria comprised of biophoton emissions, are linked to ROS and oxidative stress. In this review we investigated the association between the ability of ClearViewTM system (ClearView) to indicate the presence or absence of cardiovascular disease through mitochondria respiration as depicted through biophotonic emission. One hundred and ninety-five out of the three hundred and fifty-three human subjects enrolled in this prospective, single site study had at least one cardiovascular related diagnosis. Measurements with ClearView consisted of scanning all 10 fingers twice. Images were captured through the ClearView software and analyzed to produce a scale that indicates the presence or absence of cardiovascular disease. The association of ClearView's ability to indicate the presence or absence of cardiovascular disease w...
To assess the usefulness of skin biopsy in the assessment of patients with suspeted small fiber n... more To assess the usefulness of skin biopsy in the assessment of patients with suspeted small fiber neuropathy (SFN). Retrospective chart review of patients with sensory symptoms or findings restricted to small nerve fibers and normal nerve conduction studies (NCS) seen in a subspecialty neuromuscular private practice. Assessments were made on 145 patients. Skin biopsy was abnormal in at least one site in 86 patients (59%). There was no significant difference between patients with normal or abnormal skin biopsies with respect to age, gender, or duration of symptoms. Compared to patients with normal skin biopsies, patients with confirmed SFN were significantly more likely to have pain and were more than twice as likely to respond to standard neuropathic pain medications. Skin biopsy is useful in the diagnosis and management of patients with otherwise unexplained sensory symptoms or findings.
BMC complementary and alternative medicine, Jan 16, 2006
Flavonoid-rich extracts from the mature roots of Scutellaria baicalensis have been shown to exhib... more Flavonoid-rich extracts from the mature roots of Scutellaria baicalensis have been shown to exhibit antiproliferative effects on various cancer cell lines. We assessed the ability of an ethanolic extract of S. baicalensis root to inhibit the proliferation of malignant glioma cells. Cell lines derived from primary and recurrent brain tumors from the same patient and cells selected for resistance to the chemotherapeutic agent 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU) were used to identify antiproliferative effects of this extract when used alone and in conjunction with BCNU. Results indicated that Scutellaria baicalensis not only inhibits cellular growth in recurrent and drug resistant brain tumor cell lines, but also demonstrates an increased inhibitory effect when used in conjunction with BCNU. The results of this study support the efficacy of S. baicalensis as an anticancer agent for glioblastomas multiforme and a potential adjuvant treatment to current chemotherapeutic agents us...
Objectives. To determine if therapy with pioglitazone HCl and tretinoin could slow disease progre... more Objectives. To determine if therapy with pioglitazone HCl and tretinoin could slow disease progression in patients with ALS. Levels of tau and pNFH in the cerebrospinal fluid were measured to see if they could serve as prognostic indicators.Methods. 27 subjects on stable doses of riluzole were enrolled. Subjects were randomized to receive pioglitazone 30 mg/d and tretinoin 10 mg/BID for six months or two matching placebos. ALSFRS-R scores were followed monthly. At baseline and at the final visit, lumbar punctures (LPs) were performed to measure cerebrospinal fluid (CSF) biomarker levels.Results. Subjects treated with tretinoin, pioglitazone, and riluzole had an average rate of decline on the ALSFRS-R scale of −1.02 points per month; subjects treated with placebo and riluzole had a rate of decline of-.86(P=.18). Over six months of therapy, CSF tau levels decreased in subjects randomized to active treatment and increased in subjects on placebo. Further higher levels of pNF-H at baseli...
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