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Pediatric drugs

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https://www.readbyqxmd.com/read/29236237/outcome-of-children-and-adolescents-with-central-nervous-system-tumors-in-phase-i-trials
#1
Fernando Carceller, Francisco Bautista, Irene Jiménez, Raquel Hladun-Álvaro, Cécile Giraud, Luca Bergamaschi, Madhumita Dandapani, Isabelle Aerts, François Doz, Didier Frappaz, Michela Casanova, Bruce Morland, Darren R Hargrave, Gilles Vassal, Andrew D J Pearson, Birgit Geoerger, Lucas Moreno, Lynley V Marshall
Central nervous system (CNS) tumors are a leading cause of death in pediatric oncology. New drugs are desperately needed to improve survival. We evaluated the outcome of children and adolescents with CNS tumors participating in phase I trials within the Innovative Therapies for Children with Cancer (ITCC) consortium. Patients with solid tumors aged < 18 years at enrollment in their first dose-finding trial between 2000 and 2014 at eight ITCC centers were included retrospectively. Survival was evaluated using univariate/multivariate analyses...
December 13, 2017: Journal of Neuro-oncology
https://www.readbyqxmd.com/read/29235736/primary-and-secondary-antibiotic-resistance-of-helicobacter-pylori-in-israeli-children-and-adolescents
#2
Michal Kori, Jacob Yahav, Rita Berdinstein, Haim Shmuely
BACKGROUND: Empiric treatment for Helicobacter pylori is influenced by antibiotic susceptibility of infecting strains. A rise in the resistance rate to clarithromycin and metronidazole has been reported in pediatric populations. OBJECTIVES: To assess the primary and secondary antibiotic resistance of H. pylori isolates in Israeli children and adolescents. METHODS: A retrospective review of H. pylori isolates cultured from antral biopsies of consecutive children aged 1 to 18 years, who were referred to the Pediatric Gastroenterology Unit, Kaplan Medical Center, over a 2...
December 2017: Israel Medical Association Journal: IMAJ
https://www.readbyqxmd.com/read/29232194/persistent-ventricular-bigeminy-during-anesthesia-in-pediatric-patients-a-case-report-of-an-11-year-old-child
#3
Sheetal Dalal, Vikas Chaudhari
An 11-year-old male child with fractures in both bones in his left forearm presented for open reduction and internal fixation. The pre-anesthetic check-up and investigations did not reveal any pre-existing underlying cardio-respiratory disease. The patient had an uneventful peri-operative period during the operation and was comfortable without any anxiety or restlessness. After an uneventful induction and intubation as per routine protocol, the patient received 600 mg of amoxicillin+clavunate intravenously as an antibiotic...
December 12, 2017: Journal of Basic and Clinical Physiology and Pharmacology
https://www.readbyqxmd.com/read/29229501/proceedings-of-the-2017-santa-fe-bone-symposium-insights-and-emerging-concepts-in-the-management-of-osteoporosis
#4
REVIEW
E Michael Lewiecki, John P Bilezikian, John J Carey, Richard M Dell, Catherine M Gordon, Steven T Harris, Michael R McClung, Paul D Miller, Michael Rosenblatt
The 18th Annual Santa Fe Bone Symposium was held on August 4-5, 2017, in Santa Fe, New Mexico, USA. The symposium convenes health-care providers and clinical researchers to present and discuss clinical applications of recent advances in research of skeletal diseases. The program includes lectures, oral presentations by endocrinology fellows, case-based panel discussions, and breakout sessions on topics of interest, with emphasis on participation and interaction of all participants. Topics included the evaluation and treatment of adult survivors with pediatric bone diseases, risk assessment and management of atypical femur fractures, nonpharmacologic strategies in the care of osteoporosis, and skeletal effects of parathyroid hormone with opportunities for therapeutic intervention...
November 20, 2017: Journal of Clinical Densitometry
https://www.readbyqxmd.com/read/29228982/electroconvulsive-therapy-for-manic-state-with-mixed-and-psychotic-features-in-a-teenager-with-bipolar-disorder-and-comorbid-episodic-obsessive-compulsive-disorder-a-case-report
#5
Olof Rask, Klara Suneson, Eva Holmström, Beata Bäckström, Björn Axel Johansson
BACKGROUND: Comorbidity of bipolar disorder and obsessive-compulsive disorder is common in adolescence. Obsessive-compulsive disorder symptoms may be episodic and secondary to alterations in mood, and display specific features. Management of pediatric bipolar disorder-obsessive-compulsive disorder is challenging, as pharmacotherapy of obsessive-compulsive disorder may induce or exacerbate manic episodes and there is limited evidence of treatment efficacy. Electroconvulsive therapy is sparsely used in children and adolescents, but is documented to be a safe and efficacious intervention in adults with bipolar disorder...
December 12, 2017: Journal of Medical Case Reports
https://www.readbyqxmd.com/read/29227522/pediatric-pharmaceutical-ingestions
#6
Jennifer A Lowry, Michele Burns, Diane P Calello
Pharmaceutical ingestions comprise an important part of pediatric toxicology. Based on the 2015 Annual Report of the American Association of Poison Control Centers' National Poison Data System, coupled with recent epidemiology articles on the topic of pediatric toxicology, it is apparent that poison prevention education has not been completely successful in decreasing exposures to toxic drugs. From the unintentional ingestion in a toddler due to unsafe storage to the intentional adolescent ingestion for misuse and abuse, pharmaceutical medications continue to cause harm...
December 1, 2017: Pediatric Annals
https://www.readbyqxmd.com/read/29227461/population-pharmacokinetics-of-lopinavir-in-severely-malnourished-hiv-infected-children-and-the-effect-on-treatment-outcomes
#7
Moherndran Archary, Helen Mcllleron, Raziya Bobat, Phillip La Russa, Thobekile Sibaya, Lubbe Wiesner, Stefanie Hennig
BACKGROUND: In developing countries, malnutrition remains a common clinical syndrome at antiretroviral treatment (ART) initiation. Physiological changes due to malnutrition and during nutritional recovery could affect the pharmacokinetics of antiretroviral drugs. METHODS: HIV-infected children admitted with severe acute malnutrition were randomised to early or delayed initiation of lopinavir/ritonavir, abacavir and lamivudine using WHO weight-band dosage charts...
December 8, 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/29226303/pediatric-development-of-molecularly-targeted-oncology-drugs
#8
Shivam Kamlesh Patel, Ruby Leong, Hong Zhao, Amy Barone, Denise Casey, Qi Liu, Gilbert J Burckart, Gregory Reaman
Oncology products developed for adult cancers often receive full waivers of pediatric studies. This analysis retrospectively identified products with potential pediatric development opportunities despite a full waiver. Initial pediatric study plans submitted to the US Food and Drug Administration from 2012 to 2016 for oncology products with plans to request full waivers of pediatric studies were reviewed to determine if a scientific rationale existed for pediatric evaluation based on the molecular mechanism of action (MOA), clinical experience, nonclinical evidence, or published genome sequencing data...
December 11, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29224679/a-review-on-sle-and-malignancy
#9
REVIEW
May Y Choi, Kelsey Flood, Sasha Bernatsky, Rosalind Ramsey-Goldman, Ann E Clarke
Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by autoantibody production, complement activation, and immune complex deposition. It predominantly affects young and middle-aged women. While improvements in the diagnosis and treatment of SLE have altered prognosis, morbidity and mortality rates remain higher than the general population. In addition to renal injury, cardiovascular disease, and infection, malignancy is known to be a significant cause of death in this population...
June 2017: Best Practice & Research. Clinical Rheumatology
https://www.readbyqxmd.com/read/29224642/drug-induced-cardiac-abnormalities-in-premature-infants-and-neonates
#10
REVIEW
Luana Pesco-Koplowitz, Gary Gintant, Robert Ward, Dominique Heon, Muriel Saulnier, Jeff Heilbraun
The Cardiac Safety Research Consortium (CSRC) is a transparent, public-private partnership that was established in 2005 as a Critical Path Program and formalized in 2006 under a Memorandum of Understanding between the United States Food and Drug Administration and Duke University. Our continuing goal is to advance paradigms for more efficient regulatory science related to the cardiovascular safety of new therapeutics, both in the United States and globally, particularly where such safety questions add burden to innovative research and development...
January 2018: American Heart Journal
https://www.readbyqxmd.com/read/29224250/multiple-autologous-bone-marrow-derived-cd271-mesenchymal-stem-cell-transplantation-overcomes-drug-resistant-epilepsy-in-children
#11
Olga Milczarek, Danuta Jarocha, Anna Starowicz-Filip, Stanislaw Kwiatkowski, Bogna Badyra, Marcin Majka
There is a need among patients suffering from drug-resistant epilepsy (DRE) for more efficient and less toxic treatments. The objective of the present study was to assess the safety, feasibility, and potential efficacy of autologous bone marrow cell transplantation in pediatric patients with DRE. Two females and two males (11 months to 6 years) were enrolled and underwent a combined therapy consisting of autologous bone marrow nucleated cells (BMNCs) transplantation (intrathecal: 0.5 × 109 ; intravenous: 0...
December 10, 2017: Stem Cells Translational Medicine
https://www.readbyqxmd.com/read/29222693/neuroblastoma-pathogenesis-deregulation-of-embryonic-neural-crest-development
#12
REVIEW
Julie A Tomolonis, Saurabh Agarwal, Jason M Shohet
Neuroblastoma (NB) is an aggressive pediatric cancer that originates from neural crest tissues of the sympathetic nervous system. NB is highly heterogeneous both from a clinical and a molecular perspective. Clinically, this cancer represents a wide range of phenotypes ranging from spontaneous regression of 4S disease to unremitting treatment-refractory progression and death of high-risk metastatic disease. At a cellular level, the heterogeneous behavior of NB likely arises from an arrest and deregulation of normal neural crest development...
December 8, 2017: Cell and Tissue Research
https://www.readbyqxmd.com/read/29222234/progress-in-adult-all-incorporation-of-new-agents-to-frontline-treatment
#13
REVIEW
Jessica Leonard, Wendy Stock
Treatment of acute lymphoblastic leukemia (ALL) in adults remains a challenge, as the delivery of intensive chemotherapeutic regimens in this population is less feasible than it is in the pediatric population. This has led to higher rates of treatment-related toxicity as well as lower overall survival in the adult population. Over the past several years, a host of novel therapies (eg, immunotherapy and targeted therapies) with better tolerability than traditional chemotherapy are now being introduced into the relapsed/refractory population with very encouraging results...
December 8, 2017: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/29221705/female-fertility-preservation-in-the-pediatric-and-adolescent-cancer-patient-population
#14
REVIEW
Gabriela N Algarroba, Joseph S Sanfilippo, Hanna Valli-Pulaski
The 5-year survival rate for childhood cancer is over 80%, thereby increasing the number of young women facing infertility in the future because of the gonadotoxic effects of chemotherapy and radiation. The gonadotoxic effects of childhood cancer treatment vary by the radiation regimen and the chemotherapeutic drugs utilized. Although the American Society of Clinical Oncology guidelines recommend fertility preservation for all patients, there are several barriers and ethical considerations to fertility preservation in the pediatric and adolescent female population...
October 26, 2017: Best Practice & Research. Clinical Obstetrics & Gynaecology
https://www.readbyqxmd.com/read/29220200/a-practical-approach-to-severe-asthma-in-children
#15
Emily E Barsky, Lauren M Giancola, Sachin N Baxi, Jonathan M Gaffin
Severe asthma accounts for only a small proportion of the children with asthma, but a disproportionately high amount of resource utilization and morbidity. It is a heterogeneous entity and requires a step-wise, evidence based approach to evaluation and management by pediatric subspecialists. The first step is to confirm the diagnosis by eliciting confirmatory history and objective evidence of asthma and excluding possible masquerading diagnoses. The next step is to differentiate difficult-to-treat asthma, asthma which can be controlled with appropriate management, from asthma which requires the highest level of therapy to maintain control or remains uncontrolled despite management optimization...
December 8, 2017: Annals of the American Thoracic Society
https://www.readbyqxmd.com/read/29218740/enrichment-strategies-in-pediatric-drug-development-an-analysis-of-trials-submitted-to-the-us-food-and-drug-administration
#16
Dionna J Green, Xiaomei I Liu, Tianyi Hua, Janelle M Burnham, Robert Schuck, Michael Pacanowski, Lynne Yao, Susan K McCune, Gilbert J Burckart, Issam Zineh
Clinical trial enrichment involves prospectively incorporating trial design elements that increase the probability of detecting a treatment effect. The use of enrichment strategies in pediatric drug development has not been systematically assessed. We analyzed the use of enrichment strategies in pediatric trials submitted to the US Food and Drug Administration from 2012-2016. One hundred twelve efficacy studies associated with 76 drug development programs were assessed and their overall success rates were 78% and 75% respectively...
December 8, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29216902/improved-drug-safety-through-intensive-pharmacovigilance-in-hospitalized-pediatric-patients
#17
Alan O Vázquez-Alvarez, Lorena Michele Brennan-Bourdon, Ana Rosa Rincón-Sánchez, María Cristina Islas-Carbajal, Selene G Huerta-Olvera
BACKGROUND: The aim of this study was to detect and analyze Adverse Drug Reactions (ADRs) through Intensive Pharmacovigilance (IPV) in hospitalized pediatric patients to improve drug safety. METHODS: A prospective 6-month cross-sectional study was performed in the pediatric service of a regional hospital in Mexico in order to assess hospitalized children from 1 day to 18 years old. The inclusion criteria were: both genders, all hospitalization causes, and at least one prescribed medication (indistinct drug group)...
December 8, 2017: BMC Pharmacology & Toxicology
https://www.readbyqxmd.com/read/29214573/post-approval-studies-for-rare-disease-treatments-and-orphan-drugs
#18
William C Maier, Ronald A Christensen, Patricia Anderson
Drug development involves a multi-stage process of drug discovery, animal studies and human clinical trials to assess the safety and efficacy of new medications. Rare disease drug development involves a much smaller number of affected patients, a predominance of pediatric patients and more complicated disease presentation. Post-approval studies are designed to address several limitations associated with the rare disease clinical trials.National and international regulatory agencies in the US and Europe have adopted similar approaches to requirements post-approval data for rare diseases and orphan drug indications...
2017: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/29214572/incentivizing-orphan-product-development-united-states-food-and-drug-administration-orphan-incentive-programs
#19
Tran T Le
Over 30 years ago, the United States (US) Congress passed the Orphan Drug Act (ODA) to encourage the development of products for rare diseases or conditions ("orphan products"). The Act provided incentives to sponsors for developing products with orphan designation and established a grant program to fund studies of orphan products. Since its enactment in 1983, the ODA has been credited for bringing more than 590 orphan drugs to the market, inspiring the implementation of orphan legislation globally, and enabling the creation of other programs that extend existing knowledge of the natural history of rare diseases and stimulate the development of medical devices for children and patients with rare diseases...
2017: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/29214395/pharmacological-management-of-hereditary-angioedema-with-c1-inhibitor-deficiency-in-pediatric-patients
#20
REVIEW
Henriette Farkas
Hereditary angioedema with C1-inhibitor deficiency (C1-INH-HAE) is a form of bradykinin-mediated angioedema. It is a rare disorder with an onset during childhood in most instances. Therefore, familiarity with the options for the management of pediatric cases is indispensable. The recurrent angioedematous episodes do not respond to conventional treatments and may evolve into a life-threatening condition. In view of the recommendations adopted by international consensus in 2016, patient management and follow-up should be guided by an individualized strategy...
December 7, 2017: Paediatric Drugs
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