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efficacy and safety

Alejandro Gabriel G Gonzalez Garay, Daniel Molano Franco, Víctor H Nieto Estrada, Arturo J Martí-Carvajal, Ingrid Arevalo-Rodriguez
BACKGROUND: High altitude illness (HAI) is a term used to describe a group of mainly cerebral and pulmonary syndromes that can occur during travel to elevations above 2500 metres (˜ 8200 feet). Acute mountain sickness (AMS), high altitude cerebral oedema (HACE) and high altitude pulmonary oedema (HAPE) are reported as potential medical problems associated with high altitude ascent. In this second review, in a series of three about preventive strategies for HAI, we assessed the effectiveness of five of the less commonly used classes of pharmacological interventions...
March 12, 2018: Cochrane Database of Systematic Reviews
Vishal Hegde, Zachary D C Burke, Howard Y Park, Stephen D Zoller, Daniel Johansen, Benjamin V Kelley, Ben Levine, Kambiz Motamedi, Noah C Federman, Leanne L Seeger, Scott D Nelson, Nicholas M Bernthal
BACKGROUND: Although there is widespread acceptance of core needle biopsy (CNB) for diagnosing solid tumors, there is reluctance by some clinicians to use CNB for aneurysmal bone cysts (ABCs) as a result of concerns of safety (bleeding, nerve injury, fracture, readmission, or infection) and reliability, particularly to rule out malignant diagnoses like telangiectatic osteosarcoma. This is especially true when CNB tissue is sent from an outside hospital, where the technique used to obtain the tissue may be spurious...
March 2018: Clinical Orthopaedics and related Research
Megan Kruse, Jame Abraham
Chemotherapy-induced alopecia is a common and distressing adverse effect of many types of chemotherapy. Scalp cooling has been used since the 1970s for prevention of chemotherapy-induced alopecia; however, most data regarding this treatment modality are retrospective in nature, and use in the United States has been limited by safety concerns, specifically the potential for scalp metastases. Two prospective studies of scalp-cooling systems performed in the United States were published within the last year and add evidence supporting the efficacy and safety of scalp cooling in preventing chemotherapy-induced alopecia in patients receiving chemotherapy for solid tumor malignancies...
March 2018: Journal of Oncology Practice
Jan Powers, Michael Luebbehusen, Lillian Aguirre, Julia Cluff, Mary Ann David, Vince Holly, Lorraine Linford, Nancy Park, Rocco Brunelle
BACKGROUND: Early enteral nutrition has been shown to decrease complications and improve patient outcomes. Post pyloric feeding is recommended for patients with gastric intolerance or at high risk for aspiration. Feeding tube placement can be challenging and pose risk of pulmonary complications. Reliance on radiographic confirmation for feeding tube placement exposes the patient to radiation. Electromagnetic placement device (EMPD) may offer a method to minimize pulmonary complications, increase successful placement, and decrease radiation exposure to the patient...
March 12, 2018: Nutrition in Clinical Practice
Tracy W Krick, Neil M Bressler
PURPOSE OF REVIEW: To present some recent clinically relevant results from Diabetic Retinopathy Clinical Research (DRCR) Network trials that may guide management of diabetic macular edema (DME) or proliferative diabetic retinopathy (PDR). RECENT FINDINGS: Among eyes with DME and visual acuity 20/50 or worse, aflibercept, on average, had greater improvement in visual acuity over 2 years compared with bevacizumab or ranibizumab. Aflibercept is associated with higher rates of improvements in diabetic retinopathy severity among eyes with PDR and vision-impairing DME at baseline compared with bevacizumab or ranibizumab...
March 9, 2018: Current Opinion in Ophthalmology
Muge Cevik, Chloe Orkin
PURPOSE OF REVIEW: In an era when virological efficacy approaches 100%, novel antiretroviral (ARV) therapies must deliver better tolerability, safety, and convenient coformulated regimens. We review the phase II and III clinical data on the fixed dose combination (FDC) darunavir (DRV) 800mg / cobicistat (COBI/C) 150 mg / emtricitabine (F/FTC) 200 mg / tenofovir alafenamide fumarate (TAF) 10mg (D/C/F/TAF) for the treatment of HIV-1 infection. RECENT FINDINGS: In an exploratory phase II study, D/C/F/TAF FDC demonstrated similar virological efficacy to darunavir/cobicistat FDC + F /tenofovir disoproxil fumarate (TDF) FDC in treatment-naive HIV-1-infected individuals with favorable bone and renal outcomes...
March 9, 2018: Current Opinion in HIV and AIDS
Shun Lu, Jianhua Chang, Xiaoqing Liu, Jianhua Shi, You Lu, Wei Li, Jin-Ji Yang, Jianying Zhou, Jie Wang, Tongtong An, Lei Yang, Zhe Liu, Xiangdong Zhou, Mo Chen, Ye Hua, Weiguo Su
Purpose Patients with advanced non‒small-cell lung cancer (NSCLC) who fail two lines of chemotherapy have unmet medical needs. The kinase inhibitor fruquintinib selectively targets vascular endothelial growth factor receptors and, hence, tumor angiogenesis and lymphogenesis. This randomized, double-blind, placebo-controlled, multicenter phase II trial evaluated the efficacy and safety of fruquintinib in patients with advanced nonsquamous NSCLC who experienced disease progression after second-line chemotherapy...
March 12, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Soujanya Sunkaraneni, Elizabeth A Ludwig, Julie A Passarell, David Blum, Todd Grinnell, Jill Fiedler-Kelly
Eslicarbazepine acetate (ESL) is a once-daily oral antiepileptic drug (AED) indicated for partial-onset seizures (POS). ESL pharmacokinetics (PK) and exposure-response analyses were supported by 2 phase 3 conversion to ESL (1200, 1600 mg) monotherapy studies. The PK model development included 10 phase 1-2 studies (ESL 600-1200 mg daily). Seizure diaries were completed daily; subjects exited if seizures worsened. Exposure-response models were developed for time to study exit, probability of seizure freedom, time to first occurrence of dizziness, headache, and nausea; serum sodium levels were explored...
March 12, 2018: Journal of Clinical Pharmacology
Hideo Saka, Masahide Oki, Chiyoe Kitagawa, Yoshihito Kogure, Yuki Kojima, Akiko M Saito, Atsuko Ishida, Teruomi Miyazawa, Koji Takeda, Kazuhiko Nakagawa, Shinji Sasada, Shunichi Negoro
Background: Malignant pleural effusion is a commonly seen complication of malignancies such as lung and breast cancers. In Western countries, talc is frequently used as a standard therapeutic agent (pleurodesis agent) with the aim of alleviating symptoms including dyspnea and chest pain. Talc is not recognized as a pleurodesis agent in Japan. The aim of this study was to verify the efficacy and safety of sterilized talc (NPC-05) for the introduction of talc in Japan. Methods: The study was a single-arm, open-label, investigator-initiated trial conducted jointly at six institutions...
March 8, 2018: Japanese Journal of Clinical Oncology
Tuo Chen, Qun Zhou, Dan Zhang, Feng Jiang, Jing Wu, Jin-Yong Zhou, Xiao Zheng, Yu-Gen Chen
Background: Evidence concerning the effect of faecal microbiota transplantation (FMT) in Clostridium difficile infection (CDI) patients with inflammatory bowel disease (IBD) has not been firmly established. Therefore, we performed a systematic review and meta-analysis to evaluate FMT treatment outcomes in patients with IBD treated for CDI. Methods: An electronic search of four databases was conducted until November 1st, 2017. Cohort studies of FMT efficacy and safety in CDI patients with IBD were included...
March 8, 2018: Journal of Crohn's & Colitis
Yuesheng Shen, Wenjin Zhu, Mengye Zhao, Guige Zhao, Geng Niu, Yuwei Bai, Bo Yang, Chao Chen, Hongli Zhu
Polymerized porcine hemoglobin (pPolyHb), a kind of glutaraldehyde-polymerized haemoglobin-based oxygen carrier, was developed as a potential red blood substitute for clinical applications. Assessment of its absorption, distribution, and metabolism is a major determinant of its safety and efficacy. In this study, a series of pharmacokinetic parameters of pPolyHb were measured and calculated in different animal models, such as the top-load model, the 50% exchange transfusion model and the haemorrhagic shock model...
March 11, 2018: Artificial Cells, Nanomedicine, and Biotechnology
Annamaria Dachille, Amelia Focaccio, Lucio Selvetella, Giovanni Napolitano, Carlo Briguori
Although there is not uniform definition of high-risk percutaneous coronary intervention (PCI), patients with severe three-vessel disease, left main disease, single remaining patent vessel and/or depressed left ventricular ejection fraction are considered a high-risk population. In this setting, periprocedural hemodynamic instability represents a serious issue. Percutaneous mechanical circulatory support (MCS) devices may improve both safety and efficacy of high risk PCI. Indeed, MCS help to maintain coronary perfusion pressure and reduce myocardial workload, providing the operator sufficient time to reach the target of complete revascularization...
March 8, 2018: Minerva Cardioangiologica
Ilan Rozenberg, Andres Kotliroff, Tania Zahavi, Sydney Benchetrit
BACKGROUND: Idiopathic membranous nephropathy (IMN) is one of the most common causes of nephrotic syndrome (NS) in Caucasian adults. Most patients have good renal prognosis, but 30-40% may progress to end stage renal disease (ESRD). OBJECTIVES: To evaluate the efficacy and safety of immunosuppressive treatment (IST) in high-risk patients. METHODS: All IMN patients diagnosed by kidney biopsy from 2004-2010 were included. Clinical and laboratory data were collected at each follow-up visit...
March 2018: Israel Medical Association Journal: IMAJ
Jonas W Wastesson, Jaana E Martikainen, Helga Zoëga, Morten Schmidt, Øystein Karlstad, Anton Pottegård
Paracetamol (acetaminophen) is one of the most commonly used analgesics in Europe; however, both the safety and efficacy of paracetamol have recently been questioned. Little is known about cross-national differences in the sales of paracetamol. Using national wholesale statistics and nationwide prescription drug registers, we investigated trends in total and prescribed use of paracetamol in the Nordic countries. The total sales of paracetamol (Anatomical Therapeutic Chemical (ATC) classification system code: N02BE01) measured as defined daily doses (DDD) per 1000 inhabitants/day, and the sales by prescription (users per 1000 inhabitants per year), increased in the Nordic countries from 2000 to 2015...
March 12, 2018: Basic & Clinical Pharmacology & Toxicology
Nicole Gilgen, Ahmed Farah, Bruno Scheller, Marc-Alexander Ohlow, Norman Mangner, Daniel Weilenmann, Jochen Wöhrle, Peiman Jamshidi, Gregor Leibundgut, Sven Möbius-Winkler, Robert Zweiker, Florian Krackhardt, Christian Butter, Leonhard Bruch, Christoph Kaiser, Andreas Hoffmann, Peter Rickenbacher, Christian Mueller, Frank-Peter Stephan, Michael Coslovsky, Raban Jeger
BACKGROUND: The treatment of coronary small vessel disease (SVD) remains an unresolved issue. Drug-eluting stents (DES) have limited efficacy due to increased rates of instent-restenosis, mainly caused by late lumen loss. Drug-coated balloons (DCB) are a promising technique since native vessels remain structurally unchanged. METHODS: BASKET-SMALL 2 is a multicenter, randomized, controlled, non-inferiority trial of DCB vs. DES in native SVD for clinical endpoints...
March 11, 2018: Clinical Cardiology
M Abu El-Hamd
The study aimed to evaluate the efficacy and safety of the once-daily use of 5 mg tadalafil in the treatment of patients with premature ejaculation (PE). In a single-blind placebo-controlled clinical study, it was carried out on 100 patients with PE. All patients were randomised equally divided into two groups (50 patients each). Group 1 was given placebo in the form of oral multivitamin tablet once a day for 6 weeks. Group 2 was given 5 mg tadalafil once a day for 6 weeks. All patients were asked to complete Arabic Index of Premature Ejaculation (AIPE) before and after the treatment...
March 12, 2018: Andrologia
Xavier García Del Muro, Joan Maurel, Javier Martínez Trufero, Javier Lavernia, Antonio López Pousa, Ramón de Las Peñas, Ricardo Cubedo, José Pablo Berros, Antonio Casado Herráez, Ana de Juan, Javier Martín Broto
Background Sorafenib is a potent targeted-therapy that blockades angiogenesis and has demonstrated activity against some sarcoma subtypes. Preclinical studies suggested that treatment with sorafenib plus cytotoxic agents could result in additive efficacy. Methods Patients with advanced soft tissue sarcoma, with or without anthracycline pretreatment were included. Patients received oral sorafenib 400 mg twice daily starting on Day +2, ifosfamide 2.0 g/m2 iv infusion lasting 4 h on days 1, 2 and 3 with concurrent mesna 400 mg/m2 every three weeks until disease progression or unacceptable toxicity or up to a maximum of 6 cycles of ifosfamide (sorafenib could be continued until progressive disease or unacceptable toxicity)...
March 12, 2018: Investigational New Drugs
Yen-I Chen, Theodore James, Amol Agarwal, Todd H Baron, Takao Itoi, Rastislav Kunda, Jose Nieto, Majidah Bukhari, Olaya Brewer Gutierrez, Omid Sanaei, Robert Moran, Lea Fayad, Mouen A Khashab
Background and study aims:  Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) in malignant gastric outlet obstruction (GOO) appears to be promising; however, its role in benign GOO is unclear. The aim of this study was to ascertain the clinical efficacy and safety of EUS-GE in benign GOO. Patients and methods : This was an international retrospective series involving 5 tertiary centers. Consecutive patients who underwent EUS-GE between 1/2013 - 10/2016 for benign GOO were included...
March 2018: Endoscopy International Open
Valerie Evans, Peter Roderick, Allyson M Pollock
There is growing national and international concern about the drug regulatory system in India. Parliamentary reports have highlighted the presence of high numbers of unapproved medicines and irrational combinations of both approved and unapproved drugs in the Indian market-place. Fixed-dose combinations (FDCs) are a peculiar feature of the Indian pharmaceutical landscape. Although metformin is a first-line treatment, FDCs for diabetes in India account for two-thirds of all diabetes medicine sales, and some have not been approved by the Central Drugs Standard Control Organization (CDSCO)...
2018: BMJ Global Health
Mototsugu Kato, Noriko Ito, Mamiko Demura, Kimitoshi Kubo, Katsuhiro Mabe, Naohiko Harada
Introduction: The first drug selected for treatment of gastro-oesophageal reflux disease (GERD) and prevention of the recurrence is a proton pump inhibitor (PPI), but recently, a potassium-competitive acid blocker (P-CAB) was put on the market in Japan. Its onset of effect is faster than PPI, and it takes more than 2 days to recover acid secretion after the withdrawal period. Therefore, unlike PPI, the usefulness of every other day administration or discontinuous administration is expected...
2018: BMJ Open Gastroenterology
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