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Children and clinical trials

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https://www.readbyqxmd.com/read/29228147/association-of-early-postresuscitation-hypotension-with-survival-to-discharge-after-targeted-temperature-management-for-pediatric-out-of-hospital-cardiac-arrest-secondary-analysis-of-a-randomized-clinical-trial
#1
Alexis A Topjian, Russell Telford, Richard Holubkov, Vinay M Nadkarni, Robert A Berg, J Michael Dean, Frank W Moler
Importance: Out-of-hospital cardiac arrest (OHCA) occurs in more than 6000 children each year in the United States, with survival rates of less than 10% and severe neurologic morbidity in many survivors. Post-cardiac arrest hypotension can occur, but its frequency and association with survival have not been well described during targeted temperature management. Objective: To determine whether hypotension is associated with survival to discharge in children and adolescents after resuscitation from OHCA...
December 11, 2017: JAMA Pediatrics
https://www.readbyqxmd.com/read/29226134/success-rates-of-pulpotomies-in-primary-molars-using-calcium-silicate-based-materials-a-randomized-control-trial
#2
Yeliz Guven, Sermin Dicle Aksakal, Nilufer Avcu, Gulcan Unsal, Elif Bahar Tuna, Oya Aktoren
Objective: The aim of this study was to evaluate and compare, both clinically and radiographically, the effects of calcium silicate-based materials (i.e., ProRoot MTA [PR-MTA], MTA-Plus [MTA-P], and Biodentine [BD]) and ferric sulfate [FS] in pulpotomy of primary molars. Materials and Methods: In this randomized clinical trial, 29 healthy 5- to 7-year-old children with at least four carious primary molars with no clinical or radiographic evidence of pulp degeneration were enrolled...
2017: BioMed Research International
https://www.readbyqxmd.com/read/29223884/chronic-effect-of-different-types-of-stretching-on-ankle-dorsiflexion-range-of-motion-systematic-review-and-meta-analysis
#3
REVIEW
Diulian Muniz Medeiros, Tamara Fenner Martini
The calf muscles are one of the muscle groups that have the most need for adequate flexibility since they are deeply related to normal lower limb function. When the goal is to increase flexibility, the most commonly used technique is stretching. However, it remains unknown which stretching technique and parameters are the most effective to increase flexibility. Hence, the aim of the current review was to investigate the influence of chronic stretching on ankle dorsiflexion range of motion (DFROM) of healthy individuals...
October 27, 2017: Foot
https://www.readbyqxmd.com/read/29223706/cross-over-clinical-trial-for-evaluating-the-safety-of-camel-s-milk-intake-in-patients-who-are-allergic-to-cow-s-milk-protein
#4
E M Navarrete-Rodríguez, L A Ríos-Villalobos, C R Alcocer-Arreguín, B E Del-Rio-Navarro, J M Del Rio-Chivardi, O J Saucedo-Ramírez, J J L Sienra-Monge, R V Frias
BACKGROUND: Cow's milk protein allergy (CMPA) affects between 0.6 and 0.9% of the general population, and its treatment implies the total elimination of the intake of this protein. Camel's milk has been suggested as an alternative for patients over one year of age who suffer from CMPA due to the difference in the amino acid sequence from that of cow's milk. The objective of this study was to evaluate the safety and tolerability of camel's milk in children with CMPA. METHODS: Crossed clinical trial for the use of camel's milk vs...
December 6, 2017: Allergologia et Immunopathologia
https://www.readbyqxmd.com/read/29223416/cost-variation-across-centers-for-the-norwood-operation
#5
Kimberly E McHugh, Sara K Pasquali, Matthew A Hall, Mark A Scheurer
BACKGROUND: The Norwood operation is associated with high health care utilization, and prior studies reported substantial variability in Norwood costs across centers. However, specific factors driving this cost variation are unclear. We assessed center variability in Norwood costs and underlying mechanisms in a multicenter cohort. METHODS: Clinical data from the Pediatric Heart Network Single Ventricle Reconstruction trial were linked with cost data from the Children's Hospital Association Inpatient Essentials database...
December 6, 2017: Annals of Thoracic Surgery
https://www.readbyqxmd.com/read/29223408/clinical-outcomes-to-exercise-training-in-type-1-diabetes-a-systematic-review-and-meta-analysis
#6
D Jewiss, C Ostman, N King, N A Smart
AIMS: To establish the relationship between exercise training and clinical outcomes in people with type I diabetes. METHODS: Studies were identified through a MEDLINE search strategy, Cochrane Controlled Trials Registry, CINAHL, SPORTDiscus and Science Citation Index. The search strategy included a mix of key concepts related to exercise training; type 1 diabetes; glycaemic control for trials of exercise training in people with type 1 diabetes. Searches were limited to prospective randomized or controlled trials of exercise training in humans with type 1 diabetes lasting 12 weeks or more...
December 6, 2017: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/29222264/incorporation-of-nonchemotherapeutic-agents-in-pediatric-acute-lymphoblastic-leukemia
#7
REVIEW
Lewis B Silverman
With current available therapies, the prognosis for most children and adolescents with acute lymphoblastic leukemia (ALL) is favorable. However, the multiagent chemotherapy regimens used to treat newly diagnosed patients are associated with many acute and long-term complications, and therapy for relapsed disease is intensive and suboptimally effective. Over the last decade, several nonchemotherapeutic approaches have been evaluated, with the goal of identifying more effective, less toxic therapies that can be used in conjunction with, or even replace, current regimens...
December 8, 2017: Hematology—the Education Program of the American Society of Hematology
https://www.readbyqxmd.com/read/29221713/effect-of-grass-sublingual-tablet-immunotherapy-is-similar-in-children-and-adults-a-bayesian-approach-to-design-pediatric-sublingual-immunotherapy-trials
#8
Amarjot Kaur, David Skoner, Joseph Ibrahim, Qing Li, Richard F Lockey, Michael Blaiss, Albrecht Bufe, Jens Strodl Andersen, Giorgio Walter Canonica, Hendrik Nolte
BACKGROUND: Large sample sizes are needed for sublingual immunotherapy (SLIT) trials due to inherent data variability secondary to inconsistent allergen exposure. Obtaining large sample sizes for pediatric SLIT trials is challenging, but a Bayesian approach using prior adult data can reduce the necessary sample size. OBJECTIVE: To describe how a Bayesian framework utilizing prior information from adult trials can be used to improve pediatric SLIT clinical development...
December 5, 2017: Journal of Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/29221588/eau-thermale-d%C3%A2-av%C3%A3-ne-et-dermatite-atopique-av%C3%A3-ne%C3%A2-s-thermal-water-and-atopic-dermatitis
#9
D Guerrero, E Garrigue
Atopic dermatitis (AD) is the most frequent disease treated at the Avène hydrotherapy center. Children represent a large part of the population due to the high prevalence of AD in early childhood. Avène thermal spring water (ATSW) has been known for its therapeutic effects since the middle of the 18th century. It has been greatly studied over the last decades, with a comprehensive fundamental, pharmaco-clinical and clinical approach. Cohort studies using the Scoring Atopic Dermatitis (SCORAD) clinical score and the Dermatology Life Quality Index (DLQI) or the Children's Dermatology Life Quality Index [CDLQI]) quality of life scores, allowed to confirm the clinical results obtained from the previous studies...
January 2017: Annales de Dermatologie et de Vénéréologie
https://www.readbyqxmd.com/read/29220292/rhabdomyosarcoma-ewing-sarcoma-and-other-round-cell-sarcomas
#10
Alberto S Pappo, Uta Dirksen
Several recent advances have been made in the diagnosis and therapy of malignant small round cell tumors that affect children, particularly in rhabdomyosarcoma, Ewing sarcoma, and other round cell sarcomas. These advances have provided new insights into the pathologic, histologic, and genomic characterization of specific tumor subtypes, which has led to the identification of novel therapeutic targets and improved stratification of risk. This has, in turn, led to improved efficacy in clinical trials of new drug combinations, thereby increasing the survival of patients with newly diagnosed and refractory or recurrent round cell sarcomas...
December 8, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29218501/evaluating-safety-reporting-in-paediatric-antibiotic-trials-2000-2016-a-systematic-review-and-meta-analysis
#11
REVIEW
Paola Pansa, Yingfen Hsia, Julia Bielicki, Irja Lutsar, A Sarah Walker, Mike Sharland, Laura Folgori
BACKGROUND: There are very few options to treat multidrug-resistant bacterial infections in children. A major barrier is the duration and complexity of regulatory trials of new antibiotics. Extrapolation of safety data from adult trials could facilitate drug development for children. OBJECTIVE: We performed a systematic review on the safety of antibiotic clinical trials (CTs) in children (0-18 years) to evaluate the overall quality of safety trials conducted in children and to determine if age-specific adverse events (AEs) could be identified for specific antibiotic classes...
December 7, 2017: Drugs
https://www.readbyqxmd.com/read/29218302/canine-soft-tissue-sarcomas-can-being-a-dog-s-best-friend-help-a-child
#12
Bernard Séguin
Soft tissue sarcomas (STSs) remain a therapeutic challenge for pediatric and adolescent and young adult (AYA) patients. Still today, surgery, radiation therapy, and chemotherapy remain the mainstay of treatment. Obstacles in developing new treatment approaches to improve the outcome are: few patients to enroll in clinical trials, and the diversity of tumor biology between histologic subtypes. Pet dogs may offer an additional strategy to discover and test new therapeutic avenues. The number of dogs diagnosed with a STS each year in the United States is estimated to be around 27,000 to 95,000...
2017: Frontiers in Oncology
https://www.readbyqxmd.com/read/29216831/validity-of-mobile-electronic-data-capture-in-clinical-studies-a-pilot-study-in-a-pediatric-population
#13
Belinda von Niederhäusern, Ramon Saccilotto, Sabine Schädelin, Victoria Ziesenitz, Pascal Benkert, Marie-Luise Decker, Anya Hammann, Julia Bielicki, Marc Pfister, Christiane Pauli-Magnus
BACKGROUND: Clinical studies in children are necessary yet conducting multiple visits at study centers remains challenging. The success of "care-at-home" initiatives and remote clinical trials suggests their potential to facilitate conduct of pediatric studies. This pilot aimed to study the feasibility of remotely collecting valid (i.e. complete and correct) saliva samples and clinical data utilizing mobile technology. METHODS: Single-center, prospective pilot study in children undergoing elective tonsillectomy at the University of Basel Children's Hospital...
December 8, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/29216703/-effect-of-sports-training-in-angular-compartment-of-the-lower-limbs-in-children-footballers-aged-11-to-12-years-old
#14
J Burboa, M Bahamonde, M Inostroza, P Lillo, M Barahona, M Palet, J Hinzpeter
Anterior Cruciate Ligament (ACL) injury is an important cause of days lost in athletes. Most ACL injuries are non-contact and are associated with biomechanical risk factors that increase tension in the ACL: increased knee valgus (KV) and hip flexion (HF) and decreased flexion of knee (KF). Muscle around the knee contributes to knee stability, so fatigue produced by exercise could alter knee balance, increasing LCA tension. The aim of the study is to determine the angular behavior before and after a physical load for CF, RR and RV in children born in 2002-2003...
May 2017: Acta Ortopédica Mexicana
https://www.readbyqxmd.com/read/29215711/triage-tools-for-detecting-cervical-spine-injury-in-pediatric-trauma-patients
#15
REVIEW
Annelie Slaar, M M Fockens, Junfeng Wang, Mario Maas, David J Wilson, J Carel Goslings, Niels Wl Schep, Rick R van Rijn
BACKGROUND: Pediatric cervical spine injury (CSI) after blunt trauma is rare. Nonetheless, missing these injuries can have severe consequences. To prevent the overuse of radiographic imaging, two clinical decision tools have been developed: The National Emergency X-Radiography Utilization Study (NEXUS) criteria and the Canadian C-spine Rule (CCR). Both tools are proven to be accurate in deciding whether or not diagnostic imaging is needed in adults presenting for blunt trauma screening at the emergency department...
December 7, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29214596/preparing-for-the-future-of-rare-diseases
#16
Stephen C Groft, Manuel Posada de la Paz
Members of the rare disease community have devoted significant financial and personnel resources to address the numerous issues surrounding rare diseases. The past has been devoted to developing an emphasis on rare diseases including an emphasis on research studies or locating information on rare diseases and the requirements and limitations of conducting clinical trials with small patient populations. The expanded role of patient advocacy organizations and patient engagement in all aspects of clinical research continues to gain acceptance within the research community...
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
#17
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/29214323/economic-value-of-using-partially-hydrolysed-infant-formula-for-risk-reduction-of-atopic-dermatitis-in-high-risk-infants-not-exclusively-breastfed-in-singapore
#18
Marc F Botteman, Abhijeet J Bhanegaonkar, Erica G Horodniceanu, Xiang Ji, Bee Wah Lee, Lynette P Shek, Hugo Ps Van Bever, Patrick Detzel
INTRODUCTION: Previous trials have demonstrated reductions in atopic dermatitis (AD) incidence when healthy, high-risk, non-exclusively breastfed infants were fed until four months of age with 100% whey-based partially hydrolysed formula (PHF-W) versus standard cow's milk formula (CMF). We assessed this intervention's cost-effectiveness in Singapore. METHODS: Modelling techniques were used to simulate, from birth to Month 30, the incidence, and clinical and economic burden of AD in high-risk, non-exclusively breastfed infants fed with PHF-W or CMF for up to four months...
December 7, 2017: Singapore Medical Journal
https://www.readbyqxmd.com/read/29213283/lateral-supratrochanteric-approach-to-sciatic-and-femoral-nerve-blocks-in-children-a-feasibility-study
#19
Andrew A Albokrinov, Ulbolhan A Fesenko, Taras B Huz, Valentyna M Perova-Sharonova
Background: Sciatic and femoral nerve blocks (SNB and FNB) result in effective lower limb analgesia. Classical SNB and FNB require patient repositioning which can cause pain and discomfort. Alternative approaches to sciatic and femoral nerve blocks in supine patients can be useful. Materials and Methods: Neurostimulator-guided SNB and FNB from the lateral supratrochanteric approach were performed. Local anesthetic spread in SNB and FNB after radiographic opacification was analyzed...
2017: Anesthesiology Research and Practice
https://www.readbyqxmd.com/read/29213221/omalizumab-in-children-with-severe-allergic-asthma-the-italian-real-life-experience
#20
Amelia Licari, Riccardo Castagnoli, Chiara Denicolò, Linda Rossini, Manuela Seminara, Lucia Sacchi, Giorgia Testa, Mara De Amici, Gian Luigi Marseglia
Background: Anti-IgE treatment represents a major breakthrough in the therapeutic management of severe allergic asthma. To date, omalizumab is the only biological drug currently licensed as add-on therapy in children aged > 6 years with moderate-to-severe and severe allergic asthma uncontrolled after treatment with high dose of inhaled corticosteroids plus long-acting inhaled beta2-agonist. The clinical efficacy and safety of omalizumab treatment in the pediatric population has been extensively documented in specific trials and consistently expanded from real-life studies...
March 2017: Current Respiratory Medicine Reviews
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