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A Phase II Study of Antineoplastons A10 and AS2-1 in Children with Brain Tumors. Final Report (Protocol BT-10)

Journal of Cancer Therapy 2017年第2期8卷 173-187页

作者： Stanislaw R. Burzynski Tomasz J. Janicki Gregory S. Burzynski Ania Marszalek Burzynski clinic Houston TX USA

Despite dramatic progress over the last 50 years in the treatment of many childhood cancers, primary brain tumors remain the leading cause of death in pediatric oncology. This phase II study evaluated the efficacy and safety of Antineoplastons A10 and AS2-1 given in combination (ANP). Thirty-four patients, with a median age of 10.4 years, were enrolled in the study. Thirty-two patients (94.1%), were Caucasians while 21 (61.8%) were female and 13 were male (38.2%). Twenty-four patients (70.6%) suffered from a brainstem glioma (BSG) or high-grade tumor. Ten patients (29.4%) suffered from a low-grade tumor. A distinct sub-group of three patients with low grade tumors had a ganglioglioma (GG). Eighty-two percent of patients had failed standard treatment. Daily ANP was administered by IV infusion, every four hours, until an objective response (OR) was documented, and then for an additional eight months. The median doses of A10 and AS2-1 were 11.64 g/kg/d and 0.45 g/kg/d, respectively. A complete response (CR) was documented in two patients (5.9%), a partial response (PR) in four patients (11.8%), and stable disease (SD) in six patients (17.6%). Objective responses were observed in diffuse intrinsic pontine glioma (DIPG), thalamic pilocytic astrocytoma with brainstem involvement, ganglioglioma and pilocytic astrocytoma. Six-month progression-free survival (PFS) was 35.3%. Overall survival (OS) at two and five years was 37.6% and 34.5%, respectively. Two patients experienced grade 4 hypernatremia while three experienced grade 3 hypokalemia. In this group of patients, ANP showed good efficacy and an acceptable toxicity profile.

关键词： Antineoplastons A10 and AS2-1 Brainstem Glioma DIPG Ganglioglioma Recurrent Glioma

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A Phase II Study of Antineoplastons A10 and AS2-1 in Children with Low-Grade Astrocytomas—Final Report (Protocol BT-13)

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Journal of Cancer Therapy 2016年第12期7卷 837-850页

作者： Stanislaw R. Burzynski Tomasz J. Janicki Gregory S. Burzynski Burzynski clinic Houston TX USA

Nonresectable Low-Grade Astrocytomas (LGA) can compromise function and threaten life. For the majority of patients, the most appropriate strategy is initial chemotherapy followed by Radiation Therapy (RT). Since curative treatment is not available for most of these patients, it is reasonable to conduct clinical studies to evaluate new agents. This Phase II study evaluates efficacy and safety of Antineoplastons A10 and AS2-1 (ANP) in LGA. Sixteen children diagnosed with LGA were treated. They included 12 males and 4 females, ages 1.6 - 17.4 years (median 10.6). Efficacy was evaluated in 16 patients. The majority of patients were previously treated, but 1 patient had stereotactic biopsy only. Out of the remaining 15 patients, 6 patients received chemotherapy, and 7 patients had surgery, and 2 patients received RT and chemotherapy after surgery. The patients received treatment with ANP administered daily every 4 hours (median dose of A10 was 7.71 g/kg/d and AS2-1 was 0.26 g/kg/d) until objective response or stable disease was documented and for 8 months thereafter. The duration of ANP IV ranged from 1.4 to 286 weeks with a median of 83 weeks. A complete response was documented in 25.0%, partial response in 12.5%, and stable disease in 37.5%. Overall survival was 67.7% at 5 years, and 54.2% at 10 and 15 years. Progression-free survival was 48.1%, 34.4% and 34.4% at 5, 10, and 15 years respectively. The treatment was associated with grade 3 or grade 4 Adverse Drug Experiences (ADE) in 6 patients. There were two hypernatremias of grade 4 (12%). Grade 3 ADE included urinary frequency (6%), fatigue (6%) and hypernatremia (6%). There were no chronic toxicities, and there was a high quality of survival. ANP shows efficacy with a very good toxicity profile in this cohort of children with low-grade astrocytoma.

关键词： Antineoplastons A10 and AS2-1 Astrocytoma Low-Grade Astrocytoma Low-Grade Glioma pediatric Brain Tumors Phase II clinical Trial

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A Phase II Study of Antineoplastons A10 and AS2-1 in Patients with Brainstem Gliomas. The Report on Non-Diffuse Intrinsic Pontine Glioma (Protocol BT-11)

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Journal of Cancer Therapy 2015年第4期6卷 334-344页

作者： Stanislaw R. Burzynski Tomasz J. Janicki Gregory S. Burzynski Ania Marszalek Burzynski clinic Houston TX USA

Inoperable brainstem gliomas (BSG) are among the most difficult to treat malignancies. In the intent-to-treat (ITT) population of the BT-11 study for BSG, forty patients (median age 11.2 years old) were enrolled. Antineoplastons A10 and AS2-1 (ANP) were administered intravenously daily. The median daily dose of A10 was 8.70 g/kg/day and AS2-1 was 0.32 g/kg/day. Efficacy analyses were conducted in two subgroups: recurrent pediatric diffuse intrinsic pontine glioma (RPDIPG, N?= 17) and non-diffuse intrinsic pontine glioma (NDIPG, N?= 11). This paper reports the results of the study of the efficacy and safety of ANP in patients with NDIPG. The results in the RPDIPG group were reported before;complete response (CR) was 6%, partial response (PR) 23.5%, and stable disease (SD) 17.6%. One year overall survival (OS) was 29.4%, 2 years 11.8%, and 5, 10, and 15 years 6%. In the NDIPG group, there were 36% CR and 27.5% SD. OS at 1, 5, 10, and 15 years was 82%, 73%, 62%, and 50% correspondingly. There was only one serious adverse event (9%) reported in NDIPG represented by hypokalemia, Grade 4. The results suggest that ANP shows efficacy and an acceptable tolerability profile in patients with RPDIPG and NDIPG.

关键词： Antineoplastons A10 and AS2-1 Brainstem Glioma Diffuse Intrinsic Pontine Glioma Phase 2 clinical Trial Recurrent Glioma

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Cytokine responses in infants infected with respiratory syncytial virus

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Open Journal of Immunology 2012年第1期2卷 40-48页

作者： Morten Breindahl Klaus Rieneck Claus Nielsen Tage Justesen Klaus Bendtzen Klaus Müller Department of pediatrics Hillerod HospitalHillerodDenmark Institute for Inflammation Research(IIR) Department of RheumatologyRigshospitalet University HospitalCopenhagenDenmark Department of clinical Microbiology Hillerod HospitalHillerodDenmark pediatric clinic II Rigshospitalet University HospitalCopenhagenDenmark

Introduction: Variability in severity of Respiratory Syncytial Virus (RSV) infection is reportedly due to differences in inflammatory response. Objective: To characterize the cytokine response in RSV+ infants aged 0 - 36 months and to relate their responses to disease severity. Methods: Nasopharyngeal aspirations (NPAs) were analyzed for RSV and IL-1β, IL-2, IL-4, IL-5, IL-6, IL-10, IL-12, IL-1RA, IL-4R, IFN-γ, sTNFR1, sTNFR2, and TNF-α. clinical data were collected from the medical records. Results: We included 331 infants of whom 214 were RSV+. In comparison to RSV- infants, they had significantly higher levels of TNF-α, IL-6, IL-1β, and IFN-γ (p α, IL-6, and IL-1β. sTNFR1/2 were significantly increased in RSV+ infants. Hospitalized patients had significantly higher levels of TNF-α, sTNFR2, and IL-10 (p < 0.05) than non-hospitalized patients. The cytokine response could not be related to disease severity. We found no evidence of a skewed Th1/Th2 immune profile. Conclusion: In acute RSV disease, infected infants’ NPAs contain a significant amount of pro-inflammatory cytokines. Whether this response is beneficial or deleterious remains unanswered. Interpersonal variations in cytokine responses might be linked to an inherited tendency to variations in disease severity.

关键词： Respiratory Syncytial Virus Bronchiolitis Inflammation Cytokines Infants Aged 0-3 Years

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Boosting T cell immunity against cytomegalovirus:a potential strategy combating human aging and age-related diseases

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Signal Transduction and Targeted Therapy 2023年第10期8卷 4417-4418页

作者： Matthias Wirth Walburgis Brenner Oliver H.Kramer Department of Hematology Oncology and Cancer ImmunologyCampus Benjamin FranklinCharite-Universitatsmedizin Berlincorporate member of Freie Universitat Berlin and Humboldt-Universitat zu BerlinBerlinGermany University Medical Center Gottingen Department of GeneralVisceral and Pediatric SurgeryGottingenGermany German Cancer Consortium(DKTK) German Cancer Research Center(DKFZ)HeidelbergGermany clinic for Obstetrics and Women's Health University Medical CenterJohannes Gutenberg University MainzLangenbeckstr.155131 MainzGermany Department of Toxicology University Medical CenterMainzGermany

In a recent publication in Cell,Hasegawa and colleagues reveal that cytotoxic CD4-positive cytotoxic T lymphocytes(CD4+CTLs)eliminate senescent fibroblasts with a surface expression of the immunologically important human leukocyte antigen class Il(HLA-)and the human cytomegalovirus glycoprotein B(HCMV-gB).1 This implies that a virome-immune cell interaction controls the fate of human skin cells that are linked to the aging process and associated diseases.

关键词： immunity cytomegalovirus cytotoxic

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Routine use of thiopurines in maintaining remission in pediatric Crohn's disease

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World Journal of Gastroenterology 2014年第27期20卷 9185-9190页

作者： Brendan M Boyle Michael D Kappelman Richard B Colletti Robert N Baldassano David E Milov Wallace V Crandall Nationwide Children’s Hospital Department of pediatrics University of North Carolina at Chapel Hill University of Vermont Children’s Hospital of Philadelphia Nemours Children’s clinic

AIM: To evaluate the effectiveness of thiopurines in maintaining steroid-free remission in routine clinical practice.

关键词： Crohn's disease pediatric Remission Thiopurines Mercaptopurine

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The effect of protective genital care protocol on preventing diaper dermatit development in 0 - 18 month old children using antibiotics

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Open Journal of Nursing 2013年第1期3卷 153-161页

作者： Gulbeyaz Baran Saniye Cimen pediatric Nursing Deparment Faculty of Health SciencesAtaturk UniversityErzurumTurkey pediatric Nursing Deparment Practical and Research HospitalDokuz Eylul UniversityİzmirTurkey

Diaper dermatit is among the widely seen inflamatory skin diseases in neonatals and small 0 - 18 month old children. Control of causative agents as well as providing good genital care may prevent or reduce the risk of the disease. The aim of this study is find out the effect of protective genital care on reducing the diaper dermatit development in 0 - 18 months old inpatient 0 - 18 month old children who are using antibiotic. The study was conducted as prospective half-experimetal using control-experimental groups. Our samples comprise of 0 - 18 month old children admitted at Dokuz Eylul University Practical and Research Hospital, pediatric clinic between January and May 2009, 41 0 - 18 month old children as a control group were not under protective genital care, and 42 0 - 18 month old children as an experimental group were under the protecion and using vaseline. The mothers of the experimental group 0 - 18 month old children were given education. All 0 - 18 month old children were followed-up 3 - 7 days and the collected data were evaluated in computer using Pearson’s chisquare, Fisher’s exact chi-square and Yatest-corrected chi-square tests. The diaper dermatit develop- ment ratio was 34.1% in the control group and 7.1% in the experimental group

关键词： Diaper Dermatit Vaseline 0 - 18 Month Old Children Antibiotic Protective Genital Care

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COVID-19 pandemic and challenges in pediatric gastroenterology practice

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World Journal of Gastroenterology 2020年第36期26卷 5387-5394页

作者： Jamal Kriem Riad Rahhal Department of pediatrics Central Michigan University/Covenant Medical CenterSaginawMI 48602United States Division of pediatric Gastroenterology University of Iowa Children’s HospitalIowaIA 52242United States

The current coronavirus pandemic is imposing unpreceded challenges to the practice of pediatric *** are highlighted in their impact on performing aerosol-generating endoscopy procedures and the need to accommodate longer room turnaround time for disinfection,ensuring appropriate and consistent safety measures for patients,staff and providers,and emphasizing the importance for screening patients for active coronavirus disease(COVID)infection before endoscopy when *** patients are less likely to exhibit severe COVID-related symptoms so survey-based screening would not be a sensitive measure to identify patients with active *** address the restrictions of patients coming for face to face clinic encounters,there has been rapid expansion of telehealth services in a very short time period with several difficulties *** survive these challenges,pediatric gastroenterology practices need to adapt and accept flexibility in clinical operations with ongoing commitment to safety for patients and healthcare workers.

关键词： Coronavirus Pandemic pediatric Gastroenterology Endoscopy Screening Telehealth

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Epididymitis： revelations at the convergence of clinical and basic sciences

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Asian Journal of Andrology 2015年第5期17卷 756-763,I0007页

作者： Vera Michel Adrian Pilatz Mark P Hedger Andreas Meinhardt Department of Anatomy and Cell Biology Department of Urology Pediatric Urology and Andrology Justus-Liebig-University of Giessen 35385 Giessen Germany Centre for Reproductive Health MIMR-PHI Institute of Medical Research Melbourne Victoria Australia

Acute epididymitis represents a common medical condition in the urological outpatient clinic. Mostly, epididymitis is caused by bacterial ascent through the urogenital tract, with pathogens originating either from sexually transmitted diseases or urinary tract infections. Although conservative antimicrobial therapy is possible in the majority of patients and is usually sufficient to eradicate the pathogen, studies have shown persistent oligozoospermia and azoospermia in up to 40% of these patients. Animal models of epididymitis are created to delineate the underlying reasons for this observation and the additional impairment of sperm function that is often associated with the disease. Accumulated data provide evidence of a differential expression of immune cells, immunoregulatory genes and pathogen-sensing molecules along the length of the epididymal duct. The evidence suggests that a tolerogenic environment exists in the caput epididymidis, but that inflammatory responses are most intense toward the cauda epididymidis. This is consistent with the need to provide protection for the neo-antigens of spermatozoa emerging from the testis, without compromising the ability to respond to ascending infections. However, severe inflammatory responses, particularly in the cauda, may lead to collateral damage to the structure and function of the epididymis. Convergence of the clinical observations with appropriate animal studies should lead to better understanding of the immunological environment throughout the epididymis, the parameters underlying susceptibility to epididymitis, and to therapeutic approaches that can mitigate epididymal damage and subsequent fertility problems.

关键词： acute epididymitis animal models of bacterial epididymitis epididymal duct epididymal immune environment fertility

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Long-term effectiveness,outcomes and complications of bariatric surgery

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World Journal of clinical Cases 2023年第19期11卷 4504-4512页

作者： Milena Gulinac Dimitrina Georgieva Miteva Monika Peshevska-Sekulovska Ivan P Novakov Svetozar Antovic Milena Peruhova Violeta Snegarova Plamena Kabakchieva Yavor Assyov Georgi Vasilev Metodija Sekulovski Snezhina Lazova Latchezar Tomov Tsvetelina Velikova Department of General and clinical Pathology Medical University of PlovdivPlovdiv 4000Bulgaria Department of Genetics Sofia University"St.Kliment Ohridski"Faculty of BiologySofia 1164Bulgaria Department of Gastroenterology University Hospital LozenetzSofia 1407Bulgaria Department of Thoraco-abdominal Surgery Medical University PlovdivPlovdiv 6000Bulgaria University clinic for Digestive Surgery Medical FacultySkopjeSkopje 1000North Macedonia Department of Gastroenterology Heart and Brain HospitalBurgasBurgas 1000Bulgaria clinic of Internal Diseases Naval Hospital-VarnaMilitary Medical AcademyMedical FacultyMedical UniversityVarna 9000Bulgaria clinic of Internal Diseases Naval Hospital-VarnaMilitary Medical AcademyVarna 9010Bulgaria clinic of Endocrinology University Hospital AlexandrovskaSofia 1431Bulgaria Department of Internal Diseases Medical University–SofiaSofia 1431Bulgaria clinic of Endocrinology and Metabolic Disorders UMHAT"Sv.Georgi"Plovdiv 4000Bulgaria Department of Anesthesiology and Intensive Care University Hospital LozenetzSofia 1407Bulgaria Medical Faculty Sofia UniversitySt.Kliment OhridskiSofia 1407Bulgaria Department of pediatric University Hospital"N.I.Pirogov"Sofia 1606Bulgaria Department of Healthcare Faculty of Public Health"Prof.Tsekomir VodenicharovMDDSc"Sofia 1527Bulgaria Department of Informatics New Bulgarian UniversitySofia 1618Bulgaria Medical Faculty Sofia University St.Kliment OhridskiSofia 1407Bulgaria

Dietary imbalance and overeating can lead to an increasingly widespread *** considerations aside,obesity is defined as an excess of adipose tissue that can lead to serious health problems and can predispose to a number of pathological changes and clinical diseases,including diabetes;hypertension;atherosclerosis;coronary artery disease and stroke;obstructive sleep apnea;depression;weight-related arthropathies and endometrial and breast cancer.A body weight 20%above ideal for age,gender and height is a severe health *** surgery is a set of surgical methods to treat morbid obesity when other treatments such as diet,increased physical activity,behavioral changes and drugs have *** two most common procedures currently used are sleeve gastrectomy and gastric *** procedure has gained popularity recently and is generally considered safe and *** current data show that perioperative mortality is low and better control of comorbidities and short-term complications is achieved,more randomized trials are needed to evaluate the long-term outcomes of bariatric *** review aims to synthesize and summarize the growing evidence on the long-term effectiveness,outcomes and complications of bariatric surgery.

关键词： Bariatric surgery Long-term outcomes Obesity Roux-en-Y gastric bypass sleeve gastrectomy Effectiveness Safety Quality of life

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