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8 ["Increased Incidence of Severe Gastrointestinal Events With First-Line Paclitaxel, Carboplatin, and Vorinostat Chemotherapy for Advanced-Stage Epithelial Ovarian, Primary Peritoneal, and Fallopian Tube Cancer"] 10.1097/igc.0b013e31828566f1 http://dx.doi.org/10.1097/igc.0b013e31828566f1 2013-02-02T09:45:07Z [] 37 13 ["1048-891X", "1525-1438"] International Journal of Gynecologic Cancer <jats:sec><jats:title>Objectives</jats:title><jats:p>We sought to assess the response rate and toxicity of paclitaxel, carboplatin, andvorinostat primary induction therapy for the treatment of advanced-stage ovarian carcinoma.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Patients were treated with 6 cycles of weekly paclitaxel (80 mg/m<jats:sup>2</jats:sup>), carboplatin (6 times area under the curve), and vorinostat (200 mg) every 28 days according to an institutional review board–approved protocol. The subjects were eligible for response evaluation; in patients who achieved stable disease or better following the conclusion of primary induction chemotherapy, they were subsequently treated with a planned 12 cycles of paclitaxel (135 mg/m<jats:sup>2</jats:sup>) and vorinostat (400 mg) maintenance chemotherapy every 28 days.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Eighteen patients received a combined 90 cycles (median, 6 cycles; range, 1–6 cycles) of primary induction chemotherapy. Of the 18 subjects, 7 demonstrated a complete response, and 2 subjects exhibited a partial response (a total response rate of 50.0%). Eight patients also received a combined total of 50 cycles (median, 5 cycles; range, 1–12 cycles) of consolidation therapy. Grade 3/4 neutropenia and thrombocytopenia were observed in 9 (56.3%) and 2 (12.5%) patients. One patient (6.3%) developed grade 3 anemia, and another (6.3%) manifested a grade 3 neuropathy. Remarkably, we observed a significant gastrointestinal event (eg, bowel anastomotic perforation) in 3 patients, which effectuated the study’s closure.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Because the current study was prematurely terminated, we cannot derive a conclusive assessment regarding the efficacy of this treatment. Nevertheless, the high incidence of severe gastrointestinal toxicity warrants further consideration when using vorinostat in the adjuvant setting for patients who have undergone a bowel res… 7 [] ["Alberto A. Mendivil", "John P. Micha", "John V. Brown", "Mark A. Rettenmaier", "Lisa N. Abaid", "Katrina L. Lopez", "Bram H. Goldstein"] [""] [""] [""]
14 ["Study protocol for a randomised controlled trial evaluating the effect of prenatal omega-3 LCPUFA supplementation to reduce the incidence of preterm birth: the ORIP trial"] 10.1136/bmjopen-2017-018360 http://dx.doi.org/10.1136/bmjopen-2017-018360 2017-09-26T00:10:18Z [] 0 10 ["2044-6055", "2044-6055"] BMJ Open <jats:sec><jats:title>Introduction</jats:title><jats:p>Preterm birth accounts for more than 85% of all perinatal complications and deaths. Seventy-five per cent of early preterm births (EPTBs) occur spontaneously and without identifiable risk factors. The need for a broadly applicable, effective strategy for primary prevention is paramount. Secondary outcomes from the docosahexaenoic acid (DHA) to Optimise Mother Infant Outcome trial showed that maternal supplementation until delivery with omega-3 (ω-3) long chain polyunsaturated fatty acid (LCPUFA), predominantly as DHA, resulted in a 50% reduction in the incidence of EPTB and an increase in the incidence of post-term induction or post-term prelabour caesarean section due to extended gestation. We aim to determine the effectiveness of supplementing the maternal diet with ω-3 LCPUFA until 34 weeks’ gestation on the incidence of EPTB.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>This is a multicentre, parallel group, randomised, blinded and controlled trial. Women less than 20 weeks’ gestation with a singleton or multiple pregnancy and able to give informed consent are eligible to participate. Women will be randomised to receive high DHA fish oil capsules or control capsules without DHA. Capsules will be taken from enrolment until 34 weeks’ gestation. The primary outcome is the incidence of EPTB, defined as delivery before 34 completed weeks’ gestation. Key secondary outcomes include length of gestation, incidence of post-term induction or prelabour caesarean section and spontaneous EPTB. The target sample size is 5540 women (2770 per group), which will provide 85% power to detect an absolute reduction in the incidence of preterm birth of 1.16% (from 2.45% to 1.29%) between the DHA and control group (two sided α=0.05). The primary analysis will be based on the intention-to-treat principle.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p>Australia and New Zealand Clinical Trial Registry Num… 7 [] ["Shao J Zhou", "Karen Best", "Robert Gibson", "Andrew McPhee", "Lisa Yelland", "Julie Quinlivan", "Maria Makrides"] [] ["National Health and Medical Research Council"] ["10.13039/501100000925"]
18 ["Post-traumatic growth and its relationship to quality of life up to 9 years after liver transplantation: a cross-sectional study in Spain"] 10.1136/bmjopen-2017-017455 http://dx.doi.org/10.1136/bmjopen-2017-017455 2017-09-17T00:10:22Z [] 0 7 ["2044-6055", "2044-6055"] BMJ Open <jats:sec><jats:title>Objective</jats:title><jats:p>Little is known concerning post-traumatic growth (PTG) after liver transplantation. Against this backdrop the current study analysed the relationship between PTG and time since transplantation on quality of life. Furthermore, it compared PTG between liver transplant recipients and their caregivers.</jats:p></jats:sec><jats:sec><jats:title>Design</jats:title><jats:p>Cross-sectional case–control study.</jats:p></jats:sec><jats:sec><jats:title>Setting</jats:title><jats:p>University Hospital in Spain.</jats:p></jats:sec><jats:sec><jats:title>Participants</jats:title><jats:p>240 adult liver transplant recipients who had undergone only one transplantation, with no severe mental disease, were the participants of the study. Specific additional analyses were conducted on the subset of 216 participants for whom caregiver data were available. Moreover, results were compared with a previously recruited general population sample.</jats:p></jats:sec><jats:sec><jats:title>Outcome measures</jats:title><jats:p>All participants completed the Posttraumatic Growth Inventory, and recipients also filled in the 12-Item Short-Form Health Survey. Relevant sociodemographic and clinical parameters were also assessed.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>In the sample of 240 recipients, longer time since transplantation (&gt;9 years) was associated with more pain symptoms (p=0.026). Regardless of duration, recipients showed lower scores on most quality of life dimensions than the general population. However, high PTG was associated with a significantly higher score on the vitality quality of life dimension (p=0.021). In recipients with high PTG, specific quality of life dimensions, such as bodily pain (p=0.307), vitality (p=0.890) and mental health (p=0.353), even equalled scores in the general population, whereas scores on general health surpassed them (p=0.006). Furthermore, liver transplant recipients (n=216) compared with their caregivers showed higher t… 7 [] ["Mar\u00eda \u00c1ngeles P\u00e9rez-San-Gregorio", "Agust\u00edn Mart\u00edn-Rodr\u00edguez", "Mercedes Borda-Mas", "Mar\u00eda Luisa Avargues-Navarro", "Jos\u00e9 P\u00e9rez-Bernal", "Rupert Conrad", "Miguel \u00c1ngel G\u00f3mez-Bravo"] [] ["Spanish Ministry of Economy and Competitiveness"] [[""]]
52 ["DEVELOPMENT AND ESTABLISHMENT OF A QUALITY-FRAMEWORK FOR THE LENA PROJECT"] 10.1136/archdischild-2015-310148.72 http://dx.doi.org/10.1136/archdischild-2015-310148.72 2015-12-15T08:07:33Z ["Pediatrics, Perinatology, and Child Health"] 0 0 ["0003-9888", "1468-2044"] Archives of Disease in Childhood <jats:sec><jats:title>Background</jats:title><jats:p>The LENA (Labeling of Enalapril from Neonates up to Adolescents) project has been initiated to improve the healthcare of children with heart failure by an enalapril orodispersible mini-tablet. The LENA consortium combines academic clinical research centers, SMEs (small and medium-sized enterprises) and a patient/parent advocacy organization. The objective of the project requires to comply with respective GxP regulations like Good Manufacturing Practice (GMP), Good Clinical (Laboratory) Practice (GCP/“GCLP”1) and Good Vigilance Practice (GVP). The project team is comprised of sub-teams experienced in paediatric clinical practice, medicines development, clinical research and project management, but not all team members work in an appropriate quality framework. Aim: To establish a well-documented, efficient quality system applying a new approach for ensuring quality in all trial aspects by combining existing organization-related quality system elements of the project partners with newly developed SOPs and overarching, integrating trial-specific elements to ensure a reliable quality environment for the LENA Phase I clinical trial.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Based on the network-structure of the project organization, a strategy based on a team approach with joint responsibilities for the quality conduct of the project was pursuit, forming a QM Team consisting of the project leader, the leaders for pharmaceutical and clinical development and an external quality expert. The team compiled a quality manual and an organizational chart displaying the sub-teams and their responsibilities. Another responsibility of the team is the integration of existing SOPs and Work Instructions as well as the creation of procedures at the project level and furthermore the verification of appropriate qualification of all staff involved in the project through CVs, job descriptions and training records.</jats:p></jats:sec><jats:sec><jats:title>Resul… 7 [] ["Agnes M. Ciplea", "Karl Kleine", "Bj\u00f6rn B. Burckhardt", "Stephanie L\u00e4er", "J\u00f6rg Breitkreutz", "Lucie \u0160patenkov\u00e1", "Ingrid Klingmann"] [""] [""] [""]
57 ["Integrating complex systems science into road safety research and practice, part 1: review of formative concepts"] 10.1136/injuryprev-2019-043315 http://dx.doi.org/10.1136/injuryprev-2019-043315 2019-09-24T21:15:30Z ["Public Health, Environmental and Occupational Health"] 60 0 ["1353-8047", "1475-5785"] Injury Prevention <jats:p>Many of our most persistent public health problems are complex problems. They arise from a web of factors that interact and change over time and may exhibit resistance to intervention efforts. The domain of systems science provides several tools to help injury prevention researchers and practitioners examine deep, complex and persistent problems and identify opportunities to intervene. Using the increase in pedestrian death rates as an example, we provide (1) an accessible overview of how complex systems science approaches can augment established injury prevention frameworks and (2) a straightforward example of how specific systems science tools can deepen understanding, with a goal of ultimately informing action.</jats:p> 7 ["http://orcid.org/0000-0002-6648-0794"] ["Rebecca B Naumann", "Jill Kuhlberg", "Laura Sandt", "Stephen Heiny", "Yorghos Apostolopoulos", "Stephen W Marshall", "Kristen Hassmiller Lich"] ["R49/CE0042479"] ["National Center for Injury Prevention and Control", "Federal Highway Administration"] ["10.13039/100005217", "10.13039/100006285"]
73 ["Synchronous recurrence of concurrent colon adenocarcinoma and dedifferentiated liposarcoma"] 10.1136/bcr-2018-228868 http://dx.doi.org/10.1136/bcr-2018-228868 2019-05-14T11:54:19Z [] 19 0 ["1757-790X"] BMJ Case Reports <jats:p>A 62-year-old man presented with concurrent sigmoid colon adenocarcinoma and small bowel mesenteric dedifferentiated liposarcoma. Following surgical resection of the colon cancer, complete excision of the mesenteric sarcoma and adjuvant folinic acid, fluorouracil and oxaliplatin (FOLFOX) chemotherapy, the patient demonstrated no radiological evidence of disease for more than 2 years. The patient then developed synchronous recurrence of both cancers: the colon cancer metastasised to the liver and a pelvic lymph node, and the liposarcoma recurred in the original location. The patient underwent additional chemotherapy with complete response of the metastatic colon cancer and stable disease for the liposarcoma. The recurrent mesenteric tumour was subsequently resected. Although concurrent cancers have been reported, this unique case of synchronous recurrence raises interesting hypotheses regarding host–tumour interaction and immune surveillance.</jats:p> 7 ["http://orcid.org/0000-0001-8440-1271"] ["Eric E Jung", "F Scott Heinemann", "Colt A Egelston", "Jennifer Wang", "Raphael E Pollock", "Peter P Lee", "William W Tseng"] [""] [""] [""]
74 ["SELF-ADMINISTRATION OF IN-PATIENT MEDICATIONS: A PILOT STUDY IN CHILDREN WITH CYSTIC FIBROSIS"] 10.1136/archdischild-2016-311535.70 http://dx.doi.org/10.1136/archdischild-2016-311535.70 2016-08-18T07:07:30Z ["Pediatrics, Perinatology, and Child Health"] 1 0 ["0003-9888", "1468-2044"] Archives of Disease in Childhood <jats:sec><jats:title>Introduction</jats:title><jats:p>Children with Cystic Fibrosis (CF) have complex medication regimens, where responsibility for administration usually lies with the parent/carer until the child is older and able to take over this role.1 On admission to hospital this role is usually undertaken by nurses, leaving patients/parents/carers feeling disempowered, and unprepared for discharge.</jats:p></jats:sec><jats:sec><jats:title>Aims</jats:title><jats:p>All CF admissions to be offered the Self-Administration Of Medicines Scheme (SAM).</jats:p><jats:p>▸ Empower patients/parents/carers with responsibility of administering their own medications</jats:p><jats:p>▸ Reduce nursing time</jats:p><jats:p>▸ Educate patients/parents/carers about their medications</jats:p><jats:p>▸ Cost-saving by utilising Patients Own Medicines (PODs).</jats:p></jats:sec><jats:sec><jats:title>Method</jats:title><jats:p>A policy and training programme was developed and approved by the Trust's Medicines Management Board. This provided a framework for staff to use so that they may:</jats:p><jats:p>▸ Obtain consent</jats:p><jats:p>▸ Evaluate and re-use PODs</jats:p><jats:p>▸ Safely store and obtain supplies</jats:p><jats:p>▸ Continuously negotiate accountability for administration with patient/parent/carer.</jats:p><jats:p>The study was conducted over a 10 month period, where all families with CF admitted, were assessed for participation in SAM. The nursing teams acted as the primary assessors for SAM and any concerns were referred to the paediatric CF multidisciplinary team. To evaluate the pilot, families were given questionnaires to establish their views about the scheme. Nurses were asked to feedback if SAM decreased time for medication administration. To evaluate the associated cost-saving, data on PODs suitable for re-use was collected.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>159 children with CF were admitted to the ward, 95 (60%) were assessed to participate in the scheme and 64 (40%) of the… 7 [] ["Khola Khan", "Aoife Harrington", "Rupinder Pannu", "Sian Bentley", "Sukeshi Makhecha", "Nimla Pentayya", "Clare Pheasant"] [""] [""] [""]
77 ["Metabolic and cardiovascular effects of chronic mild hyperuricemia in rodents"] 10.1136/jim-2018-000729 http://dx.doi.org/10.1136/jim-2018-000729 2018-07-24T17:51:06Z ["General Biochemistry, Genetics and Molecular Biology", "General Medicine"] 33 0 ["1081-5589", "1708-8267"] Journal of Investigative Medicine <jats:p>Mildly elevated serum uric acid levels are common in people with metabolic syndrome and type 2 diabetes mellitus (T2DM), but whether elevated uric acid has a causal role in the pathogenesis of diabetes remains uncertain. We tested whether chronic mild hyperuricemia in rodents under controlled laboratory conditions can cause glucose intolerance in otherwise healthy animals, or whether it can worsen glucometabolic control in animals that are genetically predisposed to T2DM. We used an established model of experimental hyperuricemia in rodents with potassium oxonate dietary supplementation, which led to sustained, approximately two-fold elevation of uric acid compared with control animals. We also reversed the hyperuricemic effect of oxonate in some animals by treatment with a xanthine oxidase inhibitor. Manipulation of serum uric acid levels in Sprague-Dawley rats for up to 18 weeks did not affect fasting glucose and glucose tolerance. Blood pressure was also not affected by hyperuricemia in rats fed a Western-type diet. We next sought to determine whether uric acid may aggravate or accelerate the onset of glucometabolic abnormalities in rats already predisposed to T2DM. Chronic oxonate treatment in Zucker diabetic fatty (ZDF) and lean control rats for up to 6 weeks did not affect fasting glucose, insulin, and glucose tolerance in ZDF rats. Taken together, these findings indicate that elevated uric acid does not directly contribute to the pathogenesis of glucose intolerance and T2DM in rodents.</jats:p> 7 [] ["Sun K Park", "Tara R Rosenthal", "Jessica S Williams", "John M Shelton", "Masaya Takahashi", "Shanrong Zhang", "Ion Alexandru Bobulescu"] [] ["National Institutes of Health", "Takeda Pharmaceuticals U.S.A."] ["10.13039/100000002", "10.13039/100007723"]

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