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https://www.readbyqxmd.com/read/28719299/conventional-wisdom-versus-actual-outcomes-challenges-in-the-conduct-of-an-ebola-vaccine-trial-in-liberia-during-the-international-public-health-emergency
#1
Gregg S Larson, Beth R Baseler, Marie L Hoover, Jerome F Pierson, Jemee K Tegli, Melvin P Johnson, Mark W S Kieh, Laura A McNay, Wissedi Sio Njoh
Clinical trials are challenging endeavors. Planning and implementing an investigational vaccine trial in Liberia, in the midst of an Ebola virus disease (EVD) epidemic that World Health Organization classified a public health emergency of international concern, presented extraordinary challenges. Normally, years of preparation and a litany of tasks lay the groundwork for a successful, randomized, blinded, placebo-controlled trial focused on safety and efficacy. Difficult research settings, unpredictable events, and other unique circumstances can add complexity...
July 2017: American Journal of Tropical Medicine and Hygiene
https://www.readbyqxmd.com/read/28719287/phase-1-randomized-study-of-a-tetravalent-dengue-purified-inactivated-vaccine-in-healthy-adults-in-the-united-states
#2
Alexander C Schmidt, Leyi Lin, Luis J Martinez, Richard C Ruck, Kenneth H Eckels, Alix Collard, Rafael De La Barrera, Kristopher M Paolino, Jean-François Toussaint, Edith Lepine, Bruce L Innis, Richard G Jarman, Stephen J Thomas
AbstractThe safety and immunogenicity of four formulations of an investigational tetravalent dengue purified inactivated vaccine (DPIV), formulated at 1 or 4 μg with aluminum hydroxide (alum) or at 1 μg with an adjuvant system (AS01E or AS03B), were evaluated in a first-time-in-human, placebo-controlled, randomized, observer-blind, phase 1 trial in the continental United States. Two doses of vaccine or placebo were administered intramuscularly 4 weeks apart to 100 healthy adults 18-39 years of age, randomized 1:1:1:1:1 to receive one of four DPIV formulations or saline placebo...
June 2017: American Journal of Tropical Medicine and Hygiene
https://www.readbyqxmd.com/read/28719151/staged-treatment-in-early-psychosis-a-sequential-multiple-assignment-randomised-trial-of-interventions-for-ultra-high-risk-of-psychosis-patients
#3
REVIEW
Barnaby Nelson, G Paul Amminger, Hok Pan Yuen, Nicky Wallis, Melissa J Kerr, Lisa Dixon, Cameron Carter, Rachel Loewy, Tara A Niendam, Martha Shumway, Sarah Morris, Julie Blasioli, Patrick D McGorry
AIM: Previous research indicates that preventive intervention is likely to benefit patients "at risk" of psychosis, in terms of functional improvement, symptom reduction and delay or prevention of onset of threshold psychotic disorder. The primary aim of the current study is to test outcomes of ultra high risk (UHR) patients, primarily functional outcome, in response to a sequential intervention strategy consisting of support and problem solving (SPS), cognitive-behavioural case management and antidepressant medication...
July 18, 2017: Early Intervention in Psychiatry
https://www.readbyqxmd.com/read/28718700/use-of-single-dose-oral-gabapentin-to-attenuate-fear-responses-in-cage-trap-confined-community-cats-a-double-blind-placebo-controlled-field-trial
#4
Katherine E Pankratz, Kelli K Ferris, Emily H Griffith, Barbara L Sherman
Objectives This double-blind, placebo-controlled study evaluated the safety and efficacy of single-dose oral gabapentin administered for the attenuation of fear responses in cage-trap confined community cats. Methods Community cats presented in cage traps for trap-neuter-return (TNR) were recruited and screened for inclusion. Each enrolled cat was randomly assigned and administered one of three equal-volume, single-dose treatments: placebo, low-dose gabapentin (50 mg) or high-dose gabapentin (100 mg). At baseline, 1, 2, 3 and 12 h post-administration, a single, blinded observer scored each cat for signs of fear and sedation using published paradigms, calculated the respiratory rate and documented any observable facial injuries...
July 1, 2017: Journal of Feline Medicine and Surgery
https://www.readbyqxmd.com/read/28718334/the-preclinical-discovery-and-development-of-brexpiprazole-for-the-treatment-of-major-depressive-disorder
#5
Awais Aftab, Keming Gao
Brexpiprazole is the most recently approved second-generation antipsychotic, which is used as adjunctive therapy to antidepressants for treating major depressive disorder (MDD) with inadequate response. Brexpiprazole shares pharmacological similarities with other second-generation antipsychotics, especially aripiprazole. Area covered: This review provides a detailed overview of the pre-clinical studies of brexpiprazole, followed by a summary of its clinical studies, and a comparison with other antipsychotics in MDD...
July 18, 2017: Expert Opinion on Drug Discovery
https://www.readbyqxmd.com/read/28716815/exposure-response-analyses-of-ramucirumab-from-two-randomized-phase-iii-trials-of-second-line-treatment-for-advanced-gastric-or-gastroesophageal-junction-cancer
#6
Josep Tabernero, Atsushi Ohtsu, Kei Muro, Eric Van Cutsem, Sang Cheul Oh, György Bodoky, Yasuhiro Shimada, Shuichi Hironaka, Jaffer A Ajani, Jiri Tomasek, Howard Safran, Kumari Chandrawansa, Yanzhi Hsu, Michael Heathman, Azhar Khan, Lan Ni, Allen S Melemed, Ling Gao, David Ferry, Charles S Fuchs
Ramucirumab is an IgG1 monoclonal antibody specific for the vascular endothelial growth factor receptor-2. Ramucirumab, 8 mg/kg every two weeks, administered as monotherapy (REGARD) or in combination with paclitaxel (RAINBOW), was safe and effective in patients with previously treated advanced gastric or gastroesophageal junction (GEJ) cancer. We evaluated exposure-efficacy and exposure-safety relationships of ramucirumab from two randomized, placebo-controlled phase III trials. Sparse pharmacokinetic samples were collected and a population pharmacokinetic analysis was conducted to predict ramucirumab minimum trough concentration at steady-state (Cmin,ss)...
July 17, 2017: Molecular Cancer Therapeutics
https://www.readbyqxmd.com/read/28716656/atomoxetine-in-abstinent-cocaine-users-cognitive-subjective-and-cardiovascular-effects
#7
Elise E DeVito, Aryeh I Herman, Noah S Konkus, Huiping Zhang, Mehmet Sofuoglu
No pharmacotherapies are approved for the treatment of cocaine use disorders (CUD). Behavioral treatments for CUD are efficacious for some individuals, but recovery rates from CUD remain low. Cognitive impairments in CUD have been linked with poorer clinical outcomes. Cognitive enhancing pharmacotherapies have been proposed as promising treatments for CUD. Atomoxetine, a norepinephrine transporter inhibitor, shows potential as a treatment for CUD based on its efficacy as a cognitive enhancer in other clinical populations and impact on addictive processes in preclinical and human laboratory studies...
July 14, 2017: Pharmacology, Biochemistry, and Behavior
https://www.readbyqxmd.com/read/28716357/clinical-and-metabolic-response-to-flaxseed-oil-omega-3-fatty-acids-supplementation-in-patients-with-diabetic-foot-ulcer-a-randomized-double-blind-placebo-controlled-trial
#8
Zahra Soleimani, Fatemeh Hashemdokht, Fereshteh Bahmani, Mohsen Taghizadeh, Mohammad Reza Memarzadeh, Zatollah Asemi
BACKGROUND: Data on the effects of flaxseed oil omega-3 fatty acids supplementation on wound healing and metabolic status in subjects with diabetic foot ulcer (DFU) are scarce. OBJECTIVE: This study was conducted to evaluate the effects of flaxseed oil omega-3 fatty acids supplementation on wound healing and metabolic status in subjects with DFU. METHODS: The current randomized, double-blind, placebo-controlled trial was conducted among 60 subjects (aged 40-85years old) with grade 3 DFU...
June 28, 2017: Journal of Diabetes and its Complications
https://www.readbyqxmd.com/read/28715852/treatment-of-premenstrual-dysphoria-with-continuous-versus-intermittent-dosing-of-oral-contraceptives-results-of-a-three-arm-randomized-controlled-trial
#9
Tory A Eisenlohr-Moul, Susan S Girdler, Jacqueline L Johnson, Peter J Schmidt, David R Rubinow
BACKGROUND: Although traditionally dosed combined oral contraceptives (COCs) (21 days of active pills, 7 days of inactive pills) have not been demonstrated as superior to placebo for the treatment of premenstrual dysphoria (PMD), some randomized controlled trials (RCTs) indicate that oral contraceptives administered with a shortened or eliminated hormone-free interval are superior to placebo. However, results of such trials are mixed, and no existing studies have directly compared continuous and intermittent dosing schedules of the same oral contraceptive...
July 17, 2017: Depression and Anxiety
https://www.readbyqxmd.com/read/28715726/internet-and-mobile-based-depression-interventions-for-people-with-diagnosed-depression-a-systematic-review-and-meta-analysis
#10
REVIEW
Königbauer Josephine, Letsch Josefine, Doebler Philipp, Ebert David, Baumeister Harald
BACKGROUND: To summarize and critically evaluate the effectiveness of internet- and mobile-based interventions (IMIs) for depression in adults with a diagnosed depression. METHODS: Preregistered systematic review of RCTs investigating internet- and mobile-based interventions (IMIs) targeting adults with diagnosed depression. IMIs had to be compared with waitlist, attention placebo, other IMIs or other (face-to-face) therapies. A comprehensive search of primary studies was conducted...
July 10, 2017: Journal of Affective Disorders
https://www.readbyqxmd.com/read/28714753/pediatric-acute-onset-neuropsychiatric-syndrome-response-to-oral-corticosteroid-bursts-an-observational-study-of-patients-in-an-academic-community-based-pans-clinic
#11
Kayla Brown, Cristan Farmer, Bahare Farhadian, Joseph Hernandez, Margo Thienemann, Jennifer Frankovich
BACKGROUND: Sudden-onset severe obsessive-compulsive symptoms and/or severely restrictive food intake with at least two coinciding, similarly debilitating neuropsychiatric symptoms define Pediatric Acute-onset Neuropsychiatric Syndrome (PANS). When associated with Group A Streptococcus, the syndrome is labeled Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal infections (PANDAS). An abnormal immune response to infection and subsequent neuroinflammation is postulated to play an etiologic role...
July 17, 2017: Journal of Child and Adolescent Psychopharmacology
https://www.readbyqxmd.com/read/28714180/tofacitinib-for-the-treatment-of-moderate-to-severe-chronic-plaque-psoriasis-in-japanese-patients-subgroup-analyses-from-a-randomized-placebo-controlled-phase-3-trial
#12
Masatoshi Abe, Chikako Nishigori, Hideshi Torii, Hironobu Ihn, Kei Ito, Makoto Nagaoka, Naoki Isogawa, Isao Kawaguchi, Yukiko Tomochika, Mihoko Kobayashi, Anna M Tallman, Kim A Papp
Tofacitinib is an oral Janus kinase inhibitor. These post-hoc analyses assessed tofacitinib efficacy and safety in Japanese patients with psoriasis enrolled in a 52-week global phase 3 study. Patients received tofacitinib 5 mg, tofacitinib 10 mg or placebo twice daily (b.i.d.); placebo-treated patients advanced to tofacitinib at week 16. Primary efficacy end-points were the proportions of patients with 75% or more reduction from baseline Psoriasis Area and Severity Index (PASI-75) and Physician's Global Assessment (PGA) of "clear" or "almost clear" (PGA response) at week 16...
July 17, 2017: Journal of Dermatology
https://www.readbyqxmd.com/read/28713515/effectiveness-of-methylphenidate-and-pufa-for-the-treatment-of-patients-with-adhd-a-double-blinded-randomized-clinical-trial
#13
Mahbobeh Firouzkouhi Moghaddam, Maryam Shamekhi, Tayebeh Rakhshani
BACKGROUND: In some children with ADHD, sub-optimal levels of various nutrients including PUFA especially omega-3 has been observed, and contradictory reports exist on the results of studies conducted on the positive therapeutic effects of PUFA in patients with ADHD. OBJECTIVE: The aim of this study was to investigate the effectiveness of methylphenidate and PUFA on treatment of patients with ADHD in Zahedan, Iran. METHODS: In this clinical trial, 40 children between 6 and 12 years of age with ADHD were investigated in Zahedan in 2014...
May 2017: Electronic Physician
https://www.readbyqxmd.com/read/28712616/aripiprazole-lauroxil-compared-with-paliperidone-palmitate-in-patients-with-schizophrenia-an-indirect-treatment-comparison
#14
Chris Cameron, Jacqueline Zummo, Dharmik N Desai, Christine Drake, Brian Hutton, Ahmed Kotb, Peter J Weiden
BACKGROUND: Aripiprazole lauroxil (AL) is a long-acting injectable atypical antipsychotic recently approved for treatment of schizophrenia on the basis of a large-scale trial of two doses of AL versus placebo. There are no direct-comparison studies with paliperidone palmitate (PP; long-acting antipsychotic used most often in acute settings) for the acute psychotic episode. OBJECTIVES: To indirectly compare efficacy and safety of the pivotal AL study with all PP studies meeting indirect comparison criteria...
July 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28712490/pneumococcal-vaccination-for-splenectomized-patients-with-thalassemia-major-in-indonesia
#15
Teny Tjitra Sari, Arwin Ali P Akib, Djajadiman Gatot, Alida Roswita Harahap, Saptawati Bardosono, Sri Rezeki S Hadinegoro
INTRODUCTION: Streptococcus pneumoniae is a capsulated bacterium that can cause severe infection in patients with thalassemia major, particularly those who have undergone splenectomy. The absence of the spleen as well as zinc deficiency in splenectomized patients with thalassemia major increases the possibility of developing invasive pneumococcal infection. The aims of this study are to evaluate pneumococcal IgG levels following PCV and PPV immunizations and the effect of zinc supplementation on qualitative specific immune responses in splenectomized patients with thalassemia...
July 13, 2017: Vaccine
https://www.readbyqxmd.com/read/28712371/visual-systemizing-preference-in-children-with-autism-a-randomized-controlled-trial-of-intranasal-oxytocin
#16
Lane Strathearn, Sohye Kim, D Anthony Bastian, Jennifer Jung, Udita Iyengar, Sheila Martinez, Robin P Goin-Kochel, Peter Fonagy
Several studies have suggested that the neuropeptide oxytocin may enhance aspects of social communication in autism. Little is known, however, about its effects on nonsocial manifestations, such as restricted interests and repetitive behaviors. In the empathizing-systemizing theory of autism, social deficits are described along the continuum of empathizing ability, whereas nonsocial aspects are characterized in terms of an increased preference for patterned or rule-based systems, called systemizing. We therefore developed an automated eye-tracking task to test whether children and adolescents with autism spectrum disorder (ASD) compared to matched controls display a visual preference for more highly organized and structured (systemized) real-life images...
July 17, 2017: Development and Psychopathology
https://www.readbyqxmd.com/read/28712074/efficacy-and-safety-of-shp465-mixed-amphetamine-salts-in-the-treatment-of-attention-deficit-hyperactivity-disorder-in-adults-results-of-a-randomized-double-blind-placebo-controlled-forced-dose-clinical-study
#17
Richard H Weisler, Michael Greenbaum, Valerie Arnold, Ming Yu, Brian Yan, Margo Jaffee, Brigitte Robertson
OBJECTIVE: The objective of this randomized, double-blind, placebo-controlled study was to evaluate the efficacy and safety of SHP465 mixed amphetamine salts (MAS) in adults with attention-deficit/hyperactivity disorder (ADHD). METHODS: Eligible adults [aged 18-55 years; meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition ADHD criteria; baseline ADHD Rating Scale with Adult Prompts (ADHD-RS-AP) total scores ≥28] were randomized 1:1:1 to placebo or forced-dose SHP465 MAS (12...
July 15, 2017: CNS Drugs
https://www.readbyqxmd.com/read/28711582/a-novel-wnt-pathway-inhibitor-sm04690-for-the-treatment-of-moderate-to-severe-osteoarthritis-of-the-knee-results-of-a-24-week-randomized-controlled-phase-1-study
#18
Yusuf Yazici, Timothy E McAlindon, Roy Fleischmann, Allan Gibofsky, Nancy E Lane, Alan J Kivitz, Nebojsa Skrepnik, Eddie Armas, Christopher J Swearingen, Anita DiFrancesco, Jeyanesh R S Tambiah, John Hood, Marc C Hochberg
OBJECTIVE: To assess the safety, pharmacokinetics, and exploratory efficacy of SM04690, a novel Wnt pathway inhibitor, as a potential disease modifying treatment for knee OA. DESIGN: Subjects with Kellgren-Lawrence grade 2-3 knee OA were randomized in successive dose-escalation cohorts to receive a knee intra-articular injection with 0.03, 0.07, or 0.23 mg SM04690, or placebo (PBO) (4:1 ratio). Safety, pharmacokinetics, efficacy (WOMAC Total/Function/Pain, Pain VAS, Physician Global Assessment [MDGA], and OMERACT-OARSI Response), OA-related biomarker (P1NP, ß-CTX, and COMP), and radiographic/imaging data were collected at baseline and during 24-week follow-up...
July 12, 2017: Osteoarthritis and Cartilage
https://www.readbyqxmd.com/read/28708944/indirect-comparison-of-bronchial-thermoplasty-versus-omalizumab-for-uncontrolled-severe-asthma
#19
Robert M Niven, Michael R Simmonds, Michael J Cangelosi, Dominic P Tilden, Suzanne Cottrell, Narinder S Shargill
OBJECTIVE: Bronchial thermoplasty (BT) as an add-on therapy for uncontrolled severe asthma is an alternative to biologic therapies like omalizumab (OM). We conducted an indirect treatment comparison (ITC) to appraise comparative effectiveness of BT and OM. METHODS: A systematic literature review identified relevant randomized controlled trials. The ITC followed accepted methodology. RESULTS: The ITC comprised a sham-controlled trial of BT (AIR2) and two placebo-controlled trials of OM (INNOVATE; EXTRA)...
July 14, 2017: Journal of Asthma: Official Journal of the Association for the Care of Asthma
https://www.readbyqxmd.com/read/28708771/effect-of-clonidine-on-hemodynamic-responses-during-laparoscopic-cholecystectomy-a-systematic-review-and-meta-analysis
#20
Yi Zhang, Xi Zhang, Yu Wang, Jiefeng Zhang
BACKGROUND: Clonidine might be beneficial to the patients undergoing laparoscopic cholecystectomy. This meta-analysis focused on the influence of clonidine on hemodynamic responses in patients undergoing laparoscopic cholecystectomy. METHODS: We searched several databases including PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases. This meta-analysis included randomized controlled trials regarding the influence of clonidine versus placebo on laparoscopic cholecystectomy...
July 13, 2017: Surgical Laparoscopy, Endoscopy & Percutaneous Techniques
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