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https://www.readbyqxmd.com/read/29454255/effects-of-adjunctive-eslicarbazepine-acetate-on-neurocognitive-functioning-in-children-with-refractory-focal-onset-seizures
#1
Sergiusz Jóźwiak, P Veggiotti, J Moreira, H Gama, F Rocha, P Soares-da-Silva
PURPOSE: This was a phase-II, randomized, double-blind (DB), placebo-controlled study aimed to evaluate neurocognitive effects of eslicarbazepine acetate (ESL) as adjunctive therapy in pediatric patients with refractory focal-onset seizures (FOS). METHODS: Children (6-16years old) with FOS were randomized (2:1) to ESL or placebo. Treatment started at 10mg/kg/day, was up-titrated up to 30mg/kg/day (target dose), and maintained for 8weeks, followed by one-year open-label follow-up...
February 13, 2018: Epilepsy & Behavior: E&B
https://www.readbyqxmd.com/read/29454155/immune-checkpoint-inhibitors-in-non-small-cell-lung-cancer-nsclc-approaches-on-special-subgroups-and-unresolved-burning-questions
#2
REVIEW
J Remon, N Vilariño, N Reguart
Immune checkpoint inhibitors (ICIs) have been incorporated in the treatment strategy of advanced non-small cell lung cancer (NSCLC). Beyond the already approved indications in first- and second-line setting of advanced NSCLC, new data has recently emerged demonstrating its efficacy in locally advanced disease as maintenance after chemo-radiotherapy and currently several trials are also exploring its efficacy in earlier stages of the disease to evaluate whether these results could be extrapolated to the adjuvant setting...
February 8, 2018: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/29454051/retrospective-observational-study-of-the-use-of-artemether-lumefantrine-in-the-treatment-of-malaria-in-japan
#3
Fukumi Nakamura-Uchiyama, Yuichi Katanami, Tadashi Kikuchi, Saho Takaya, Satoshi Kutsuna, Taiichiro Kobayashi, Yasutaka Mizuno, Tetsuo Hasegawa, Michiko Koga, Yukihiro Yoshimura, Chihiro Hasegawa, Yasuyuki Kato, Mikio Kimura, Haruhiko Maruyama
BACKGROUND: The Research Group on Chemotherapy of Tropical Diseases, Japan, introduced artemether-lumefantrine (AL) in late 2002, mainly for treating uncomplicated Plasmodium falciparum malaria. Because AL was on the market in Japan in March 2017, the effectiveness and safety of AL were analyzed to help medical personnel use AL optimally. METHODS: Case report forms submitted by the attending physicians were analyzed. When necessary, direct contact with the attending physicians was made to obtain detailed information...
February 14, 2018: Travel Medicine and Infectious Disease
https://www.readbyqxmd.com/read/29454009/24-vs-72-hours-of-hypothermia-for-pediatric-cardiac-arrest-a-pilot-randomized-controlled-trial
#4
Ericka L Fink, Robert S B Clark, Rachel P Berger, Anthony Fabio, Derek C Angus, R Scott Watson, John J Gianakas, Ashok Panigrahy, Clifton W Callaway, Michael J Bell, Patrick M Kochaneka
AIM: Children surviving cardiac arrest (CA) lack proven neuroprotective therapies. The role of biomarkers in assessing response to interventions is unknown. We hypothesized that 72 versus 24 h of hypothermia (HT) would produce more favorable biomarker profiles after pediatric CA. METHODS: This single center pilot randomized trial tested HT (33 ± 1 °C) for 24 vs. 72 h in 34 children with CA. Children comatose after return of circulation aged 1 week to 17 years and treated with HT by their physician were eligible...
February 14, 2018: Resuscitation
https://www.readbyqxmd.com/read/29453628/safety-tolerability-and-preliminary-activity-of-imgn529-a-cd37-targeted-antibody-drug-conjugate-in-patients-with-relapsed-or-refractory-b-cell-non-hodgkin-lymphoma-a-dose-escalation-phase-i-study
#5
Anastasios Stathis, Ian W Flinn, Sumit Madan, Kami Maddocks, Arnold Freedman, Steven Weitman, Emanuele Zucca, Mihaela C Munteanu, M Lia Palomba
Background CD37 is expressed on B-cell lymphoid malignancies, thus making it an attractive candidate for targeted therapy in non-Hodgkin lymphoma (NHL). IMGN529 is an antibody-drug conjugate comprising a CD37-binding antibody linked to the maytansinoid DM1, a potent anti-mitotic agent. Methods This first-in-human, phase 1 trial recruited adult patients with relapsed or refractory B-cell NHL. The primary objective was to determine the maximum tolerated dose (MTD) and recommended phase 2 dose. Secondary objectives were to evaluate safety, pharmacokinetics, and preliminary clinical activity...
February 17, 2018: Investigational New Drugs
https://www.readbyqxmd.com/read/29453627/a-phase-i-and-pharmacokinetic-study-of-taladegib-a-smoothened-inhibitor-in-japanese-patients-with-advanced-solid-tumors
#6
Hideki Ueno, Shunsuke Kondo, Shusuke Yoshikawa, Koichi Inoue, Valérie Andre, Masaomi Tajimi, Haruyasu Murakami
Background This phase I dose-escalation study investigated the safety of the Smoothened inhibitor taladegib in Japanese patients with advanced solid tumors. Methods Patients received taladegib orally once daily for 28-day cycles, using a 3 + 3 dose-escalation method. The primary objective was the safety and tolerability of taladegib at doses up to the global recommended dose (400 mg). Secondary objectives included pharmacokinetics, changes in skin glioma-associated oncogene homolog 1 (Gli1) transcript levels, and antitumor activity...
February 17, 2018: Investigational New Drugs
https://www.readbyqxmd.com/read/29453626/drug-approval-based-on-randomized-phase-3-trials-for-relapsed-malignancy-analysis-of-oncologic-drugs-granted-accelerated-approval-publications-and-clinical-trial-databases
#7
Sumimasa Nagai, Keiya Ozawa
Background As relapsed disease is frequently the first target of newly developed therapies, it is vital to address the difficulty in demonstrating the efficacy of new drugs for relapsed malignancy in randomized phase 3 trials. Methods We analyzed the approved indications, target populations, and development status of post-marketing confirmatory trials of all oncology-related drugs that were granted accelerated approval for both hematological and solid malignancies. Furthermore, we searched for randomized phase 3 trials for adult patients with relapsed lymphoid malignancy, other than chronic lymphocytic leukemia (CLL) and multiple myeloma (MM)...
February 17, 2018: Investigational New Drugs
https://www.readbyqxmd.com/read/29453623/a-novel-suction-coagulation-integrated-probe-for-achieving-better-hemostasis-development-and-clinical-use
#8
Hidekazu Takahashi, Naotsugu Haraguchi, Junichi Nishimura, Taishi Hata, Chu Matsuda, Hirofumi Yamamoto, Tsunekazu Mizushima, Masaki Mori, Yuichiro Doki, Kiyokazu Nakajima
PURPOSES: Modern electrosurgical tools have a specific coagulation mode called "soft coagulation". However, soft coagulation has not been widely accepted for surgical operations. To optimize the soft coagulation environment, we developed a novel suction device integrated with an electrosurgical probe, called the "Suction ball coagulator" (SBC). In this study, we aimed to optimize the SBC design with a prototyping process involving a bench test and preclinical study; then, we aimed to demonstrate the feasibility, safety, and potential effectiveness of the SBC for laparoscopic surgery in clinical settings...
February 17, 2018: Surgery Today
https://www.readbyqxmd.com/read/29453592/patient-specific-registration-of-3d-ct-angiography-cta-with-x-ray-fluoroscopy-for-image-fusion-during-transcatheter-aortic-valve-implantation-tavi-increases-performance-of-the-procedure
#9
I Vernikouskaya, W Rottbauer, J Seeger, B Gonska, V Rasche, Jochen Wöhrle
OBJECTIVES: The aim of this study was to adapt patient-specifically a co-registration procedure for image fusion (IF) of a pre-interventional CT dataset with real-time X-ray (XR) fluoroscopy during transfemoral transcatheter aortic valve implantation (TAVI), enabling improved performance of the procedure. BACKGROUND: The ability to use 3D models of the respective anatomies to complement the anatomic information obtained by XR fluoroscopy and provide a greater degree of real-time anatomical guidance holds great potential for complex cardiac interventions, especially for TAVI procedures with cerebral protection...
February 16, 2018: Clinical Research in Cardiology: Official Journal of the German Cardiac Society
https://www.readbyqxmd.com/read/29453443/role-of-the-mesolimbic-dopamine-system-in-relief-learning
#10
Dana Mayer, Evelyn Kahl, Taygun C Uzuneser, Markus Fendt
The relief from an aversive event is rewarding. Since organisms are able to learn which environmental cues can cease an aversive event, relief learning helps to better cope with future aversive events. Literature data suggest that relief learning is affected in various psychopathological conditions, such as anxiety disorders. Here, we investigated the role of the mesolimbic dopamine system in relief learning. Using a relief learning procedure in Sprague Dawley rats, we applied a combination of behavioral experiments with anatomical tracing, c-Fos immunohistochemistry, and local chemogenetic and pharmacological interventions to broadly characterize the role of the mesolimbic dopamine system...
February 5, 2018: Neuropsychopharmacology: Official Publication of the American College of Neuropsychopharmacology
https://www.readbyqxmd.com/read/29452942/early-safety-and-efficacy-of-the-combination-of-bedaquiline-and-delamanid-for-the-treatment-of-patients-with-drug-resistant-tuberculosis-in-armenia-india-and-south-africa-a-retrospective-cohort-study
#11
Gabriella Ferlazzo, Erika Mohr, Chinmay Laxmeshwar, Catherine Hewison, Jennifer Hughes, Sylvie Jonckheere, Naira Khachatryan, Virginia De Avezedo, Lusine Egazaryan, Amir Shroufi, Stobdan Kalon, Helen Cox, Jennifer Furin, Petros Isaakidis
BACKGROUND: Bedaquiline and delamanid have been approved for treatment of multidrug-resistant (MDR) tuberculosis in the past 5 years. Because of theoretical safety concerns, patients have been unable to access the two drugs in combination. Médecins Sans Frontières has supported the use of combination bedaquiline and delamanid for people with few treatment options since 2016. We describe early safety and efficacy of regimens containing the bedaquiline and delamanid combination in patients with drug-resistant tuberculosis in Yerevan, Armenia; Mumbai, India; and Khayelitsha, South Africa...
February 13, 2018: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/29452843/ticagrelor-versus-clopidogrel-in-east-asian-patients-with-acute-coronary-syndrome-systematic-review-and-meta-analysis
#12
Naoki Misumida, Shunsuke Aoi, Sun Moon Kim, Khaled M Ziada, Ahmed Abdel-Latif
BACKGROUND: Bleeding complications are associated with unfavorable outcomes in patients with acute coronary syndrome (ACS). Compared to Whites, several studies demonstrated a higher risk of bleeding in Asians who present with acute myocardial infarction. To date, the efficacy and safety of ticagrelor in East Asian population have not been well established. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials that compared ticagrelor and clopidogrel in East Asian patients with acute coronary syndrome (ACS)...
January 31, 2018: Cardiovascular Revascularization Medicine: Including Molecular Interventions
https://www.readbyqxmd.com/read/29452841/impact-of-age-following-treatment-of-severely-calcified-coronary-lesions-with-the-orbital-atherectomy-system-3-year-follow-up
#13
Michael S Lee, Richard A Shlofmitz, Brad J Martinsen, Sanjum Sethi, Jeffrey W Chambers
OBJECTIVES: We investigated the safety and efficacy of coronary orbital atherectomy to treat severely calcified lesions prior to stenting based upon age. BACKGROUND: The ORBIT II study reported the safety and efficacy with orbital atherectomy in 443 patients with severely calcified lesions. Elderly patients undergoing percutaneous coronary intervention may be at increased risk for major adverse cardiac events (MACE) and death compared with younger patients. METHODS: Patients were stratified according to age (≥75 year old [174/443, 39...
January 31, 2018: Cardiovascular Revascularization Medicine: Including Molecular Interventions
https://www.readbyqxmd.com/read/29452756/quantification-of-thrombus-formation-in-malapposed-coronary-stents-deployed-in-vitro-through-imaging-analysis
#14
Jonathan Brown, Caroline C O'Brien, Augusto C Lopes, Kumaran Kolandaivelu, Elazer R Edelman
Stent thrombosis is a major complication of coronary stent and scaffold intervention. While often unanticipated and lethal, its incidence is low making mechanistic examination difficult through clinical investigation alone. Thus, throughout the technological advancement of these devices, experimental models have been indispensable in furthering our understanding of device safety and efficacy. As we refine model systems to gain deeper insight into adverse events, it is equally important that we continue to refine our measurement methods...
February 9, 2018: Journal of Biomechanics
https://www.readbyqxmd.com/read/29452688/comparison-of-the-efficacy-and-safety-of-orbital-and-rotational-atherectomy-in-calcified-narrowings-in-patients-who-underwent-percutaneous-coronary-intervention
#15
Edward Koifman, Hector M Garcia-Garcia, Kayode O Kuku, Alexandre H Kajita, Kyle D Buchanan, Arie Steinvil, Toby Rogers, Nelson L Bernardo, Robert Lager, Robert A Gallino, Itsik Ben-Dor, Augusto D Pichard, Rebecca Torguson, Jiaxiang Gai, Lowell F Satler, Ron Waksman
We aimed to compare the safety and efficacy of rotational atherectomy (RA) and orbital atherectomy (OA) during percutaneous coronary intervention in an all-comer population with severely calcified lesions. We included all patients who underwent percutaneous coronary intervention with OA or RA in our institution from October 2013 until October 2016. Comparison of baseline and procedural characteristics, along with acute complication rates and postprocedural cardiac enzyme elevation, was performed. There were 191 RA and 57 OA patients...
February 13, 2018: American Journal of Cardiology
https://www.readbyqxmd.com/read/29452684/evaluation-of-the-safety-tolerability-and-efficacy-of-pimavanserin-versus-placebo-in-patients-with-alzheimer-s-disease-psychosis-a-phase-2-randomised-placebo-controlled-double-blind-study
#16
Clive Ballard, Carol Banister, Zunera Khan, Jeffrey Cummings, George Demos, Bruce Coate, James M Youakim, Randall Owen, Srdjan Stankovic
BACKGROUND: Pimavanserin is a selective 5-HT 2A receptor inverse agonist and antagonist approved in the USA for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. No safe or effective pharmacological treatment is approved for psychosis in patients with Alzheimer's disease. Therefore, we aimed to evaluate the safety, tolerability, and efficacy of pimavanserin versus placebo in patients with Alzheimer's disease psychosis. METHODS: We did a phase 2, randomised, double-blind, placebo-controlled, single-centre (with multiple affiliated nursing home sites across the UK) study...
March 2018: Lancet Neurology
https://www.readbyqxmd.com/read/29451712/lipid-modifying-effects-of-chitosan-supplementation-in-humans-a-pooled-analysis-with-trial-sequential-analysis
#17
Haohai Huang, Ying Zou, Honggang Chi, Dan Liao
SCOPE: We performed a pooled analysis with trial sequential analysis (TSA) to evaluate the efficacy and safety of chitosan supplementation on serum lipids in humans. METHODS AND RESULTS: Medline, EMBASE and CENTRAL databases were queried. Impact was expressed as a weighted mean difference (WMD) and 95% confidence interval (CI). Sensitivity analysis was conducted using the leave-one-out method. Statistical heterogeneity, publication bias, TSA and subgroup analyses were also assessed...
February 16, 2018: Molecular Nutrition & Food Research
https://www.readbyqxmd.com/read/29451701/phase-1b-study-of-pasireotide-everolimus-and-selective-internal-radioembolization-therapy-for-unresectable-neuroendocrine-tumors-with-hepatic-metastases
#18
Hyun S Kim, Walid L Shaib, Chao Zhang, Ganji Purnachandra Nagaraju, Christina Wu, Olatunji B Alese, Zhengjia Chen, Edith Brutcher, Meredith Renfroe, Bassel F El-Rayes
BACKGROUND: Neuroendocrine tumors (NETs) metastasize to the liver. Everolimus and selective internal radioembolization (SIRT) are approved treatments. Pasireotide is a somatostatin analogue with an affinity for somatostatin receptors 1, 2, 3, and 5. Everolimus and pasireotide may potentiate SIRT radiosensitization and inhibit rebound angiogenesis. This study evaluated the safety of pasireotide, everolimus, and SIRT. METHODS: This 3 + 3 phase 1 trial evaluated 3 dose levels of everolimus (2...
February 16, 2018: Cancer
https://www.readbyqxmd.com/read/29451447/peripheral-nerve-grafts-implanted-into-the-substantia-nigra-in-patients-with-parkinson-s-disease-during-deep-brain-stimulation-surgery-1-year-follow-up-study-of-safety-feasibility-and-clinical-outcome
#19
Craig G van Horne, Jorge E Quintero, John T Slevin, Amelia Anderson-Mooney, Julie A Gurwell, Andrew S Welleford, John R Lamm, Renee P Wagner, Greg A Gerhardt
OBJECTIVE Currently, there is no treatment that slows or halts the progression of Parkinson's disease. Delivery of various neurotrophic factors to restore dopaminergic function has become a focus of study in an effort to fill this unmet need for patients with Parkinson's disease. Schwann cells provide a readily available source of such factors. This study presents a 12-month evaluation of safety and feasibility, as well as the clinical response, of implanting autologous peripheral nerve grafts into the substantia nigra of patients with Parkinson's disease at the time of deep brain stimulation (DBS) surgery...
February 16, 2018: Journal of Neurosurgery
https://www.readbyqxmd.com/read/29451410/inclisiran-for-the-treatment-of-dyslipidemia
#20
Toshiyuki Nishikido, Kausik K Ray
Dyslipidemia is one of the most important risk factors for cardiovascular disease. Insufficient reduction in LDL-C from existing therapies in patients at high risk of atherogenic cardiovascular disease is an unmet clinical need. Circulating PCSK9 causes hypercholesterolemia by reducing LDL receptors in hepatocytes. Areas covered: PCSK9 inhibition has emerged as a promising new therapeutic strategy to reduce LDL-C. Inclisiran, a novel, synthetic, siRNA molecule, inhibits PCSK9 synthesis in hepatocytes. Inclisiran targets intracellular PCSK9 synthesis specifically, resulting in a dose-dependent, long-term, significant reduction in LDL-C...
February 16, 2018: Expert Opinion on Investigational Drugs
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