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https://www.readbyqxmd.com/read/29161531/pulmonary-safety-and-tolerability-of-inhaled-levodopa-cvt-301-administered-to-patients-with-parkinson-s-disease
#1
Peter A LeWitt, Rajesh Pahwa, Alexander Sedkov, Ann Corbin, Richard Batycky, Harald Murck
BACKGROUND: CVT-301, an inhaled levodopa (LD) formulation, is under development for relief of OFF periods in Parkinson's disease (PD). Previously, we reported that CVT-301 improved OFF symptoms relative to placebo. In this study, we evaluate pulmonary function in patients treated with a single dose of CVT-301 or placebo for 3 hours, or received multiple doses/day for 4 weeks. METHODS: As part of two phase 2 studies, pulmonary safety and tolerability of CVT-301 were evaluated in PD patients experiencing motor fluctuations (≥2 hours OFF/day), Hoehn and Yahr stage 1-3, and forced expiratory volume in 1 second/forced vital capacity ratio ≥75% of predicted (in ON state)...
November 21, 2017: Journal of Aerosol Medicine and Pulmonary Drug Delivery
https://www.readbyqxmd.com/read/29159774/pharmacokinetics-pharmacodynamics-and-safety-of-rasagiline-transdermal-patch-a-preliminary-study-in-healthy-chinese-subjects
#2
Wenjia Zhou, Chengzhe Lv, Quanying Zhang, Shunlin Zong, Meng Wang
BACKGROUND AND OBJECTIVES: Rasagiline tablet is an oral MAO-B inhibitor applied in early or advanced Parkinson's disease (PD). However, when patients with PD cannot take their usual oral medications, a rasagiline transdermal patch can be used as a way to offer continuous rasagiline while avoiding plasma concentration peaks and troughs. The objectives of this study were to investigate the pharmacokinetics, pharmacodynamics, and safety of the rasagiline transdermal patch in healthy Chinese subjects...
November 20, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/29158830/sustained-release-talazoparib-implants-for-localized-treatment-of-brca1-deficient-breast-cancer
#3
Jodi E Belz, Rajiv Kumar, Paige Baldwin, Noelle Castilla Ojo, Ana S Leal, Darlene B Royce, Di Zhang, Anne L van de Ven, Karen T Liby, Srinivas Sridhar
Talazoparib, a potent PARP inhibitor, has shown promising clinical and pre-clinical activity by inducing synthetic lethality in cancers with germline Brca1/2 mutations. Conventional oral delivery of Talazoparib is associated with significant off-target effects, therefore we sought to develop new delivery systems in the form of an implant loaded with Talazoparib for localized, slow and sustained release of the drug at the tumor site in Brca1-deficient breast cancer. Poly(lactic-co-glycolic acid) (PLGA) implants (0...
2017: Theranostics
https://www.readbyqxmd.com/read/29158665/pharmacokinetics-and-tolerability-of-mb12066-a-beta-lapachone-derivative-targeting-nad-p-h-quinone-oxidoreductase-1-two-independent-double-blind-placebo-controlled-combined-single-and-multiple-ascending-dose-first-in-human-clinical-trials
#4
Seokuee Kim, SeungHwan Lee, Joo-Youn Cho, Seo Hyun Yoon, In-Jin Jang, Kyung-Sang Yu
MB12066 is a molecule derived from β-lapachone that shown effects on obesity in previous studies. The present studies were conducted to evaluate the tolerability and pharmacokinetics (PK) of MB12066 after the oral administration of single and multiple doses to healthy volunteers. The study comprised 2 independent, randomized, double-blind, placebo-controlled, combined single and multiple ascending dose first-in-human clinical trials to evaluate the safety, tolerability and PK of MB12066 in healthy Korean volunteers...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29158663/a-comparative-pharmacokinetic-and-tolerability-analysis-of-the-novel-orotic-acid-salt-form-of-tenofovir-disoproxil-and-the-fumaric-acid-salt-form-in-healthy-subjects
#5
Yu Kyong Kim, Mun Ju Choi, Tae Young Oh, Kyung-Sang Yu, SeungHwan Lee
A novel orotic acid salt form of tenofovir disoproxil (DA-2802) was developed and is expected to replace the fumaric acid salt form. The pharmacokinetic (PK) characteristics and tolerability profiles of DA-2802 were compared to those of tenofovir disoproxil fumarate (TDF, Viread(®)) in healthy subjects. A randomized, open-label, single-dose study was conducted in 36 healthy subjects using a two-treatment, two-period, and two-sequence crossover design. Subjects received a single oral dose of 319 mg DA-2802 or 300 mg TDF, during each period, with a 7-day washout...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/29158374/maternal-igg-immune-complexes-induce-food-allergen-specific-tolerance-in-offspring
#6
Asa Ohsaki, Nicholas Venturelli, Tess M Buccigrosso, Stavroula K Osganian, John Lee, Richard S Blumberg, Michiko K Oyoshi
The role of maternal immune responses in tolerance induction is poorly understood. To study whether maternal allergen sensitization affects offspring susceptibility to food allergy, we epicutaneously sensitized female mice with ovalbumin (OVA) followed by epicutaneous sensitization and oral challenge of their offspring with OVA. Maternal OVA sensitization prevented food anaphylaxis, OVA-specific IgE production, and intestinal mast cell expansion in offspring. This protection was mediated by neonatal crystallizable fragment receptor (FcRn)-dependent transfer of maternal IgG and OVA immune complexes (IgG-IC) via breast milk and induction of allergen-specific regulatory T (T reg) cells in offspring...
November 20, 2017: Journal of Experimental Medicine
https://www.readbyqxmd.com/read/29158281/pharmacokinetics-and-safety-of-omadacycline-in-subjects-with-impaired-renal-function
#7
Jolene K Berg, Evan Tzanis, Lynne Garrity-Ryan, Stephen Bai, Surya Chitra, Amy Manley, Stephen Villano
Many antibiotics require dosing adjustments in patients with renal impairment and/or in those undergoing hemodialysis. Omadacycline, the first aminomethylcycline antibiotic in late-stage clinical development, displays activity against a broad-spectrum of bacterial pathogens, including resistant strains. Data from completed phase 3 acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) studies showed intravenous (IV) to once-daily oral omadacycline to be clinically effective and well tolerated...
November 20, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/29158141/patient-reported-tolerance-in-treatments-approved-in-neuroendocrine-tumors-a-national-survey-from-the-french-group-of-endocrine-tumors
#8
Arnaud Plante, Eric Baudin, Christine Do Cao, Olivia Hentic, Olivier Dubreuil, Eric Terrebonne, Victoire Granger, Denis Smith, Catherine Lombard-Bohas, Thomas Walter
BACKGROUND: Patients with advanced neuroendocrine tumors (NETs) benefit from an increasing number of treatments. The patient's preference could help physicians to choose among these options. Our patient-reported survey aims to compare the perceived tolerance of NETs treatments. METHODS: Patients treated by at least three different therapeutic options have evaluated their perceived tolerance from one (very good) to five (very poor) for each single treatment. Referent physician confirmed the type and ranking over time of each treatment...
November 17, 2017: Clinics and Research in Hepatology and Gastroenterology
https://www.readbyqxmd.com/read/29157945/food-allergy-a-review-and-update-on-epidemiology-pathogenesis-diagnosis-prevention-and-management
#9
Scott H Sicherer, Hugh A Sampson
This review provides general information to serve as a primer for those embarking on understanding food allergy and also details advances and updates in epidemiology, pathogenesis, diagnosis and treatment that have occurred over the four years since our last comprehensive review. Although firm prevalence data are lacking, there is a strong impression that food allergy has increased, and rates as high as ∼10% have been documented. Genetic, epigenetic and environmental risk factors are being increasingly elucidated, opening the potential for improved prevention and treatment strategies targeted to those at risk...
November 17, 2017: Journal of Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/29156994/experimental-diabetes-impairs-maternal-reproductive-performance-in-pregnant-wistar-rats-and-their-offspring
#10
Leticia Bequer, Tahiry Gómez, José L Molina, Alain Álvarez, Claudia Chaviano, Sonia Clapés
The aim of this study was to determine the effect of mild hyperglycemia on metabolism during pregnancy, the maternal reproductive performance, and the characteristics of the offspring in neonatal mild diabetic-induced Wistar rats. The experimental diabetes model was generated by neonatal streptozotocin administration (100 mg of streptozotocin/Kg bw/sc) in female Wistar rats. At adulthood, the control and diabetic group were mated. At the 20th day of gestation, a maternal and fetal blood sample were collected for biochemical measurement...
November 20, 2017: Systems Biology in Reproductive Medicine
https://www.readbyqxmd.com/read/29155496/insulin-resistance-in-chronic-kidney-disease
#11
REVIEW
Hong Xu, Juan J Carrero
This review provides an overview of insulin resistance (IR) in patients with chronic kidney disease (CKD). IR is a pathological state in which target tissues fail to respond normally to insulin. IR is understood as a consequence of CKD and its prevalence rises particularly in advanced CKD stages. Mechanisms leading to IR are complex and multifactorial, involving post-receptor signaling defects, unhealthy lifestyles, metabolic acidosis, inflammation, oxidative stress, vitamin D deficiency, anemia, and uremic toxicity, as shown by human and experimental studies over the last 30 years...
December 2017: Nephrology
https://www.readbyqxmd.com/read/29155164/a-new-promising-candidate-to-overcome-drug-resistant-herpes-simplex-virus-infections
#12
Elisabeth Zinser, Adalbert Krawczyk, Petra Mühl-Zürbes, Ulrich Aufderhorst, Lena Stich, Mirko Zaja, Stefan Strobl, Alexander Steinkasserer, Christiane Silke Heilingloh
Infections with Herpes simplex viruses (HSV) belong to the most common human diseases worldwide, resulting in symptoms ranging from painful, but commonly self-limiting lesions of the orofacial or genital tract to severe infections of the eye or life-threatening generalized infections. Frequent HSV-reactivations at the eye may lead to the development of herpetic stromal keratitis, which is one of the major causes of infectious blindness in developed countries. The vast majority of life-threatening generalized infections occur in immunocompromised individuals, such as transplant recipients or patients suffering from advanced human immunodeficiency virus (HIV) infection with concurrent HSV-reactivation...
November 15, 2017: Antiviral Research
https://www.readbyqxmd.com/read/29155153/the-glp-1-response-to-glucose-does-not-mediate-beta-and-alpha-cell-dysfunction-in-hispanics-with-abnormal-glucose-metabolism
#13
Elizabeth Adams, Pauline Genter, Emma Keefe, Kevin Sandow, Virginia Gray, Jerome I Rotter, Yii-Der Ida Chen, Eli Ipp
AIMS: Glucagon-like peptide-1 (GLP-1) contributes to insulin secretion after meals. Though Hispanics have increased risk for type 2 diabetes mellitus, it is unknown if impaired GLP-1 secretion contributes to this risk. We therefore studied plasma GLP-1 secretion and action in Hispanic adults. METHODS: Hispanic (H; n=31) and non-Hispanic (nH; n=15) participants underwent an oral glucose tolerance test (OGTT). All participants were categorized by glucose tolerance into four groups: normal glucose tolerant non-Hispanic (NGT-nH; n = 15), normal glucose tolerant Hispanic (NGT-H; n = 12), impaired glucose tolerant Hispanic (IGT-H; n = 11), or newly diagnosed type 2 diabetes mellitus, Hispanic (T2D-H; n = 8)...
November 16, 2017: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/29155122/screening-for-diabetes-prevention-with-diabetes-risk-scores-a-balancing-act
#14
Crystal Man Ying Lee, Vincent L Versace, Jonathan A Malo, Jonathan E Shaw, James A Dunbar, Stephen Colagiuri
AIMS: To compare the diabetes prevention impact and cost of several screening scenarios for diabetes prevention programs with the scenario which included an oral glucose tolerance test (OGTT). METHODS: We included 4864 participants of the Australian Diabetes, Obesity and Lifestyle study who were aged ≥40 years, did not have known diabetes at baseline, and attended the five year follow-up. The proportions of participants eligible or ineligible for diabetes prevention program were estimated for each scenario...
November 15, 2017: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/29153866/a-phase-i-trial-of-the-pi3k-inhibitor-buparlisib-combined-with-capecitabine-in-patients-with-metastatic-breast-cancer
#15
Autumn J McRee, Paul K Marcom, Dominic T Moore, William C Zamboni, Zachary A Kornblum, Zhiyuan Hu, Rachel Phipps, Carey K Anders, Katherine Reeder-Hayes, Lisa A Carey, Karen E Weck, Charles M Perou, E Claire Dees
BACKGROUND: Buparlisib is an oral pan-class I phosphotidyinositol-3-kinase (PI3K) inhibitor. The present phase I study evaluated the safety, pharmacokinetics, and efficacy of buparlisib with capecitabine in patients with metastatic breast cancer. PATIENTS AND METHODS: Patients received buparlisib once daily (range, 50 to 100 mg) for 3 weeks with capecitabine twice daily (range, 1000 to 1250 mg/m(2)) for 2 weeks with a 1-week break. Dose escalation used a traditional "3 + 3" design with standard definitions of dose-limiting toxicity (DLT) and maximum tolerated dose...
October 28, 2017: Clinical Breast Cancer
https://www.readbyqxmd.com/read/29152762/optimizing-lonafarnib-treatment-for-the-management-of-chronic-delta-hepatitis-the-lowr-hdv-1-study
#16
Cihan Yurdaydin, Onur Keskin, Çağdaş Kalkan, Fatih Karakaya, Aysun Çalişkan, Ersin Karatayli, Senem Karatayli, A Mithat Bozdayi, Christopher Koh, Theo Heller, Ramazan Idilman, Jeffrey S Glenn
BACKGROUND AND RATIONALE: In a proof-of-concept (POC) study, the oral prenylation inhibitor lonafarnib (LNF) decreased HDV RNA during 4 weeks of treatment. Here we explored optimal LNF regimens. METHODS: 15 patients (5 groups; 3 per group) completed dosing as follows: 1) LNF 200 mg BID (12 weeks); 2) LNF 300 mg BID (12 weeks); 3) LNF 100 mg TID (5 weeks); 4) LNF 100 mg BID + pegylated interferon alfa (PEG-IFNα) 180 mcg QW (8 weeks); and 5) LNF 100 mg BID + ritonavir (RTV) 100 mg QD (8 weeks)...
November 20, 2017: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
https://www.readbyqxmd.com/read/29151531/repeated-hypoglycemic-episodes-with-postprandial-hyperinsulinemia-after-the-recovery-from-acute-weight-loss-revealed-by-continuous-glucose-monitoring-and-the-oral-glucose-tolerance-test
#17
Seizaburo Masuda, Masanori Murakami, Ryotaro Bouchi, Isao Minami, Koshi Hashimoto, Takanobu Yoshimoto, Yoshihiro Ogawa
We herein report a case of a 20-year-old woman who experienced hypoglycemia in parallel with acute weight loss confirmed by continuous glucose motoring (CGM). When she recovered from the acute weight loss, CGM revealed nocturnal and postprandial hypoglycemia. Six months were required to resolve the hypoglycemia and hyperinsulinemia after the recovery of her weight. Our case suggests that the adaption of insulin secretion to the rapid loss of weight and to the recovery of weight may require a long period of time, leading to the excessive secretion of insulin relative to the glucose level and repeated hypoglycemic episodes with postprandial hyperinsulinemia...
November 20, 2017: Internal Medicine
https://www.readbyqxmd.com/read/29151300/the-effect-of-antidiuretic-hormone-on-urine-and-serum-electrolyte-levelsin-children-with-primary-monosymptomatic-nocturnal-enuresis
#18
(no author information available yet)
Background/aim: The data concerning the effects of desmopressin on water/electrolyte disturbances of children with primary monosymptomatic nocturnal enuresis (PMNE) are limited. In the present study we aimed to evaluate the effect and tolerability of desmopressin on blood and urine electrolytes and osmolality in PMNE.Materials and methods: Thirty-five children with PMNE between the ages of 5 and 15 participated in the study. Patients collected urine during the daytime and acknowledged the night time fluid restriction before starting to use the desmopressin tablets...
November 13, 2017: Turkish Journal of Medical Sciences
https://www.readbyqxmd.com/read/29151280/oral-nutritional-supplementation-in-patients-undergoing-peritoneal-dialysis-a-randomised-crossover-pilot-study
#19
Karen M Salamon, Kelly Lambert
BACKGROUND: Malnutrition is a significant problem in those undergoing peritoneal dialysis (PD). Factors such as gastrointestinal (GI) symptoms and the need for a fluid reduced diet can limit tolerance and thereby the efficacy of oral nutritional supplements to treat malnutrition. OBJECTIVES: To evaluate the acceptability and impact of two different forms of oral nutrition supplementation for 16 weeks on nutritional markers and quality of life of malnourished patients undergoing PD...
November 19, 2017: Journal of Renal Care
https://www.readbyqxmd.com/read/29151239/increased-serum-3-carboxy-4-methyl-5-propyl-2-furanpropanoic-acid-cmpf-levels-are-associated-with-glucose-metabolism-in-chinese-pregnant-women
#20
J Yi, H Jin, R Zhang, S Zhang, P Chen, X Yu, X Zhang
PURPOSE: Previous studies have found that 3-carboxy-4-methyl-5-propyl-2-furanpropanoic acid (CMPF) was associated with diabetes. This study aimed to investigate the relationship between abnormal increased CMPF levels and gestational diabetes mellitus (GDM). METHODS: We recruited 828 pregnant women, and all of them underwent an oral glucose tolerance test (OGTT). We screened out 141 GDM patients and 230 pregnant women with normal glucose tolerance as controls. The serum CMPF concentration in participants was measured, and the relationship between the serum CMPF concentration and various parameters and biochemical indices was analyzed...
November 18, 2017: Journal of Endocrinological Investigation
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