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Clinical Therapeutics

Nao Tsuruya, Toshio Kawashima, Masataka Shiozuka, Yoichi Nakanishi, Daisuke Sugiyama
In the field of medicine, cooperation between academia and industry has become increasingly important in order to create innovative pharmaceuticals and medical devices. This paper presents an overview of academia-industry cooperation within the medical field in Japan. The overview begins with a brief history of the origins of academia-industry cooperation in Japan, and how it has developed up to the present day. It continues with examples of current academia-industry cooperation in the medical field. This includes details about organizations such as the Academic Research Organization (ARO) established by Japanese universities and the government to promote academia-industry cooperation; details about various matching events such as BioJapan; information about networks such as ARDENT, established to return results of basic research to society, and information about a case study by Kyushu University's Hospital Center for Clinical and Translational Research...
November 9, 2018: Clinical Therapeutics
Alexis A Coulis, William C Mackey
PURPOSE: This study aims to review the published literature concerning the use of novel oral anticoagulants (NOACs) in the treatment and prevention of venous thromboembolism (VTE) and to identify the appropriate niche for each NOAC by comparing their behaviors in Phase III and Phase IV clinical trial settings. METHODS: The database was used to identify Phase III and postmarketing (Phase IV) randomized controlled trials concerning the efficacy and safety profiles of the oral NOACs (apixaban, dabigatran etexilate, exodaban, and rivaroxaban) for the treatment or prevention of VTE...
November 5, 2018: Clinical Therapeutics
Aernoud T L Fiolet, Stefan M Nidorf, Arend Mosterd, Jan H Cornel
PURPOSE: Disease management of stable coronary artery disease consists of controlling hemostasis and lipid regulation. No treatment strategies preventing plaque erosion or rupture are yet available. Cholesterol crystal-induced inflammation leading to plaque destabilization is believed to be an important factor contributing to plaque instability and might well be amenable to treatment with anti-inflammatory drugs. Colchicine has anti-inflammatory properties with the potential to address both the direct and indirect inflammatory mechanisms in the plaque...
November 2, 2018: Clinical Therapeutics
Richard I Shader
No abstract text is available yet for this article.
November 2, 2018: Clinical Therapeutics
Masanori Sawada, Daisuke Sugiyama, Takenobu Nii, Katsuhiro Konno, Hardy T S Kagimoto
Regenerative medicine mediated by the transplantation of somatic stem cells and functional cells derived from induced pluripotent stem cells has great potential in the treatment of currently incurable diseases and thus has attracted significant public attention. To put this into practice, several functional cell lines were developed and laws regarding regenerative medicine were put in force in Japan. In this report, we introduce recent efforts of a bioventure company with special attention to the case of Healios K...
November 2, 2018: Clinical Therapeutics
Ünal Güntekin, Hasan Ali Gümrükçüoğlu, Mehmet Yaman, Fatih Öztürk, Aytaç Akyol, Fatma Nur Gümrükçüoğlu, Yunus Emre Okudan, Veysel Tosun, Yasemin Behram Kandemir
PURPOSE: Cardiovascular disease (CVD) due to atherosclerosis is the leading cause of early mortality and morbidity. The current European guidelines on CVD prevention in clinical practice recommend the use of the Systematic Coronary Risk Estimation (SCORE) system. The current American Heart Association guidelines recommend the use of the new pooled cohort risk assessment equations to estimate the 10-year atherosclerotic CVD risk. The purpose of this article was to investigate the compliance of dyslipidemia guidelines in daily practice in patients with dyslipidemia or who have risk factors for CVD...
November 1, 2018: Clinical Therapeutics
Rachel Ballinger, Jake Macey, Andrew Lloyd, John Brazier, Joanne Ablett, Sorrel Burden, Simon Lal
PURPOSE: Short bowel syndrome (SBS) is the main cause of intestinal failure. Intravenous supplementation (parenteral support [PS]) helps patients regain health but can affect patients' health-related quality of life (HRQoL). The value of health states associated with the number of days on PS per week is unknown in the United Kingdom. The objectives of the present study were to develop health state vignettes for SBS and PS, and to estimate health state utilities by using the time trade-off (TTO) technique...
November 1, 2018: Clinical Therapeutics
Hitoshi Kawazoe, Akari Murakami, Michiko Yamashita, Kanako Nishiyama, Kana Kobayashi-Taguchi, Saaya Komatsu, Reina Aoki, Erina Kusakabe, Haruna Yamasawa, Yoshihiro Yakushijin, Tomonori Nakamura, Yoshiaki Kamei
PURPOSE: The aim of this study was to identify a high-risk or low-risk population for chemotherapy-induced nausea and vomiting among patients with breast cancer treated with a current standard 3-drug antiemetic regimen and receiving anthracycline. METHODS: We analyzed data from chemotherapy-naive Japanese patients with breast cancer, who had received the first cycle of anthracycline-based regimen and were treated with a 3-drug combination of aprepitant, palonosetron, and dexamethasone...
November 1, 2018: Clinical Therapeutics
Irena Krčmová, Jakub Novosad, Eva Malá, Jan Krejsek
PURPOSE: Omalizumab has demonstrated clinical efficacy in severe allergic asthma by reducing exacerbation rates and increasing quality of life. However, data concerning its sustained effect after treatment discontinuation are still needed. METHODS: This analysis was an observational pilot study (simple within-subjects design) of 12 patients experiencing severe asthma, treated with omalizumab, for 1 year after treatment discontinuation. We prospectively analyzed clinical measurements (pulmonary functions, inhaled corticosteroid [ICS] doses, Asthma Control Test [ACT] scores, skin prick test [SPT] positivity, fraction of exhaled nitric oxide, and exacerbation rates) and laboratory test results (eosinophils and total immunoglobulin E levels) at the time of discontinuation and 6 and 12 months thereafter...
October 31, 2018: Clinical Therapeutics
Marc Labetoulle, Andrea Leonardi, Mourad Amrane, Dahlia Ismail, Jean-Sébastien Garrigue, Gerhard Garhöfer, Maite Sainz de la Maza, Christophe Baudouin
PURPOSE: Results from a 6-month double-masked and a 6-month open-label study (SANSIKA) established the efficacy and safety of once-daily 0.1% cyclosporin A cationic emulsion (CsA CE) in severe keratitis due to dry eye disease (DED). This article presents results from the Post-SANSIKA study, a 24-month extension of SANSIKA assessing the sustained efficacy of CsA CE after treatment discontinuation. METHODS: Time to relapse (corneal fluorescein staining [CFS] score ≥4 [modified Oxford scale]) was assessed after treatment discontinuation in patients from the SANSIKA study who had CFS improvement from a score of 4 to ≤2 after 6 or 12 months of treatment with CsA CE...
October 30, 2018: Clinical Therapeutics
Christopher-Paul Milne, Kenneth I Kaitin
No abstract text is available yet for this article.
October 27, 2018: Clinical Therapeutics
Anna Lena Kahl, Julia Kirchhof, Liubov Petrakova, Juliana Müller, Julian Laubrock, Alexandra Brinkhoff, Meike Unteroberdörster, Sven Benson, Benjamin Wilde, Oliver Witzke, Manfred Schedlowski
PURPOSE: The learned immunosuppressive placebo response has been demonstrated in experimental animals, healthy humans, and patients, and is suggested as a therapy for improving immunopharmacologic treatment. It remains unclear, however, whether potential adverse events induced by the drug are also behaviorally conditioned. Employing an established taste-immune learning paradigm in healthy humans using the calcineurin inhibitor and immunosuppressive drug cyclosporine A (CsA) as an unconditioned stimulus, we investigated whether and to what extent perceived adverse events induced by acute CsA administration are behaviorally conditioned...
October 25, 2018: Clinical Therapeutics
Lei Sun, David McDonnell, Lisa von Moltke
PURPOSE: ALKS 3831 is composed of a flexible dose of olanzapine and a fixed dose of 10-mg samidorphan (a novel opioid system modulator), designed to provide the established antipsychotic efficacy of olanzapine and to mitigate olanzapine-induced weight gain. To support clinical development of ALKS 3831, we conducted a multicenter, randomized, open-label, Phase I study to obtain steady-state exposure for olanzapine and samidorphan and short-term safety at the intended therapeutic dose range of ALKS 3831 10/10 (10-mg olanzapine/10-mg samidorphan) to ALKS 3831 20/10 (20-mg olanzapine/10-mg samidorphan) in subjects with schizophrenia...
October 19, 2018: Clinical Therapeutics
Carla Rognoni, Uberto Andrea Bassi, Michele Cataldo, Clotilde Crovella, Feliciano Crovella, Diego Cuccurullo, Maria Cudemo, Enrico De Nicola, Paolo De Paolis, Vincenzo Maria Greco, Antonio Marioni, Silvia Pessione, Micaela Piccoli, Alessandro Rosignoli, Carlo Sagnelli, Roberto Silvestro, Rosanna Tarricone, Vincenzo Trapani, Giorgio Soliani
PURPOSE: With the development of newer prostheses for hernia repair, it is nowadays difficult to understand the total cost of managing patients treated with these advanced medical devices, especially in the complex abdomen, in which various complications may occur. The aim of this study was to determine the economic implications of these prostheses in order to inform decision making in the management of incisional hernia repair. METHODS: A budget impact analysis model was developed to evaluate the economic consequences related to the management of patients undergoing complex (Centers for Disease Control and Prevention wound class II-III or Ventral Hernia Working Group grade 2/3) incisional hernia repair through biosynthetic, synthetic, or biological meshes, from the hospital perspective in Italy...
October 19, 2018: Clinical Therapeutics
James M Kidd, Lindsay M Avery, Tomefa E Asempa, David P Nicolau, Joseph L Kuti
No abstract text is available yet for this article.
October 16, 2018: Clinical Therapeutics
Richard I Shader
No abstract text is available yet for this article.
September 24, 2018: Clinical Therapeutics
Ignacio Conde-Carmona, Sandra García-Medina, Juan M Jiménez-Vargas, Alberto Martínez-Muñoz, Sung-Hack Lee
PURPOSE: The aim of this study was to assess the pharmacokinetic interactions between a newly developed dipeptidyl peptidase (DPP)-4 inhibitor, gemigliptin, and metformin in healthy Mexican male volunteers, and the differences in the pharmacokinetic profile of gemigliptin between Korean and Mexican healthy volunteers. METHODS: This was a multiple-dose, randomized, open-label, 3-way, 3-period crossover study. Subjects were randomized to 1 of 3 treatment sequences and received gemigliptin 50mg once a day, metformin1000mg BID, or both drugs during a 7-day treatment period, and underwent sampling for pharmacokinetic analysis and tolerability assessments...
September 22, 2018: Clinical Therapeutics
Min Yang, Yong Luo, Tao Liu, Xiaolong Zhong, Jiao Yan, Qi Huang, Jie Tao, Qingjuan He, Mingyang Guo
PURPOSE: Cardiovascular and diabetic complications are the main causes of death in patients with rheumatoid arthritis (RA). Puerarin has potential protective effects against subclinical atherosclerosis and insulin resistance, but the clinical evidence is still not sufficient to draw definitive conclusions. Therefore, we performed the clinical trial to assess the effect of puerarin on carotid intima-media thickness (CIMT) in RA. METHODS: This is an open, controlled, randomized, and parallel-group comparison study of 119 patients with a definite diagnose of active RA...
September 20, 2018: Clinical Therapeutics
Stephen E Daniels, Hartley C Atkinson, Ioana Stanescu, Chris Frampton
PURPOSE: Acute pain is a significant burden to the individual and to society. There is a clear need for a pain medication that provides improved analgesia over common analgesics, without compromising tolerability. The goal of this study was to determine the efficacy of a new fixed-dose combination of acetaminophen 975 mg and ibuprofen 292.5 mg (FDC 975/292.5) relative to acetaminophen or ibuprofen monotherapy, or placebo. METHODS: This prospective, multicenter, randomized, double-blind, placebo-controlled, Phase III trial included 408 adult volunteers aged 18 to 60 years experiencing moderate to severe pain after surgical removal of at least 2 impacted third molars...
September 20, 2018: Clinical Therapeutics
Maria A Ramos-Roman
The prevention of diabetes and obesity in the young starts with the prevention and treatment of modifiable maternal risk factors encompassing the period from before conception until weaning. Major modifiable variables are characteristics and behaviors that include prepregnancy weight, gestational weight gain, glycemia, and intensity and duration of breastfeeding. Much of the early programming of resistance or vulnerability to age-related diseases is influenced by the integrated balance of maternal hormones transferred to the offspring by milk...
September 20, 2018: Clinical Therapeutics
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