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https://www.readbyqxmd.com/read/29444478/detection-of-drug-safety-signals-from-clinical-trials-data-role-of-susars
#1
Christelle Perez, Pascale Olivier, Barbara Lortal, Sophie Duranton, Jean-Louis Montastruc, Anne-Laurène Colin, Emilie Toulza, Madlyne Becker, Laura Hamy, Sabrina Crepin, Caroline Roussillon, Anne Gimbert, Nadine Petitpain, Francesco Salvo
One of the main goals of safety management in clinical trials is to detect suspected unexpected serious adverse reactions (SUSARs). The unexpectedness concerns the nature, frequency or severity of an adverse reaction. Drug safety signals could thus be retrieved, and a study was performed to investigate whether SUSARs allow signal detection in pharmacovigilance. Data from six academic safety units were collected from 2005 to 2016. Characteristics of SUSARs were analysed and signals were identified i) by evaluating the presence of other causes, ii) by assessing the summary of product characteristics (SPC), iii) by searching for specific safety information in Pubmed and health agencies, and iv) by investigating the narrative of each case...
February 11, 2018: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/29444281/surgical-management-of-esophageal-sarcoma-a-multicenter-european-experience
#2
D Mege, L Depypere, G Piessen, A E Slaman, B P L Wijnhoven, A Hölscher, M Nilsson, M I van Berge Henegouwen, J J B van Lanschot, W Schroeder, P A Thomas, P Nafteux, X B D'Journo
Esophageal sarcomas are rare and evidence in literature is scarce making their management difficult. The objective is to report surgical and oncological outcomes of esophageal sarcoma in a large multicenter European cohort. This is a retrospective multicenter study including all patients who underwent en-bloc esophagectomy for esophageal sarcoma in seven European tertiary referral centers between 1987 and 2016. The main outcomes and measures are pathological results, early and long-term outcomes. Among 10,936 esophageal resections for cancer, 21 (0...
February 9, 2018: Diseases of the Esophagus: Official Journal of the International Society for Diseases of the Esophagus
https://www.readbyqxmd.com/read/29444092/the-impact-of-early-life-nutrition-and-housing-on-growth-and-reproduction-in-dairy-cattle
#3
G Curtis, C McGregor Argo, D Jones, D Grove-White
Contentious issues in calf rearing include milk feeding practices and single versus group housing. The current study was performed on a high producing 170 Holstein cow dairy farm, to investigate the impact of nutrition and housing on growth and reproduction. Heifer calves (n = 100) were allocated in birth order to one of two commonly used management strategies. All calves received 3-4 litres of dam specific colostrum within 6 hours of birth. Group A calves were group housed from birth and fed milk replacer (MR) ad libitum via a computerised machine utilising a single teat, with weaning commencing at 63 days of age...
2018: PloS One
https://www.readbyqxmd.com/read/29443862/red-tides-mass-casualty-and-whole-blood-at-sea-red-tides
#4
Benjamin T Miller, Andrew H Lin, Susan C Clark, Andrew P Cap, Joseph J Dubose
BACKGROUND: The U.S. Navy's casualty-receiving ships provide remote damage control resuscitation (RDCR) platforms to treat injured combatants deployed afloat and ashore. We report a significant mass casualty incident aboard the USS Bataan, and the most warm fresh whole blood (WFWB) transfused at sea for traumatic hemorrhagic shock since the Vietnam War. METHODS: Casualty-receiving ships have robust medical capabilities, including a frozen blood bank with packed red blood cells (pRBC) and fresh frozen plasma (FFP)...
February 13, 2018: Journal of Trauma and Acute Care Surgery
https://www.readbyqxmd.com/read/29443857/the-fast-exam-can-reliably-identify-patients-with-significant-intraabdominal-hemorrhage-in-life-threatening-pelvic-fractures
#5
Nicole Townsend Christian, Clay Cothren Burlew, Ernest E Moore, Andrea E Geddes, Amy E Wagenaar, Charles J Fox, Fredric M Pieracci
BACKGROUND: The Focused Abdominal Sonography for Trauma (FAST) exam has been reported to be unreliable in pelvic fracture patients. Additionally, given the advent of new therapeutic interventions, such as Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA), rapid identification of intraabdominal hemorrhage compared to zone III hemorrhage may guide different therapeutic strategies. We hypothesized that FAST is reliable for detecting clinically significant intraabdominal hemorrhage in the face of complex pelvic fractures...
February 14, 2018: Journal of Trauma and Acute Care Surgery
https://www.readbyqxmd.com/read/29443835/venous-thromboembolism-incidence-after-craniofacial-surgery
#6
Wilson I Omesiete, James A Walker, Jack C Yu
INTRODUCTION: Current protocols for venous thromboembolism (VTE) prophylaxis after craniofacial surgery (CFS) vary widely with substantial disagreements in both indications and managements. An evidence-based approach to this issue requires the following: the incidence of postoperative VTE, comorbidities associated with coagulopathy, risk reduction after VTE prophylaxis, and complications attributable to prophylaxis. This study addresses the first two. DESIGN: Retrospective cross-sectional study...
February 13, 2018: Annals of Plastic Surgery
https://www.readbyqxmd.com/read/29443825/maternal-influenza-immunization-and-prevention-of-severe-clinical-pneumonia-in-young-infants-analysis-of-randomized-controlled-trials-conducted-in-nepal-mali-and-south-africa
#7
Saad B Omer, Dayna R Clark, Anushka R Aqil, Milagritos D Tapia, Marta C Nunes, Naoko Kozuki, Mark C Steinhoff, Shabir A Madhi, Niteen Wairagkar
BACKGROUND: To evaluate the effect of antenatal influenza vaccination on all-cause severe infant pneumonia, we performed pooled analysis of three randomized-controlled trials conducted in Nepal, Mali, and South Africa. METHODS: The trials were coordinated from the planning phase. The follow-up period was 0-6 months post-partum in Nepal and Mali, and 0-24 weeks in South Africa. Pregnant women with gestational age 17-34 weeks in Nepal, ≥28 weeks in Mali, and 20-36 weeks in South Africa were enrolled...
February 13, 2018: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/29443820/unstable-c1-fracture-managed-with-internal-fixation-using-lateral-mass-screws-a-case-report
#8
Jonathan C Yu, Thomas E Niemeier, Sakthivel R Manoharan
CASE: A 47-year-old woman presented with an unstable C1 fracture after falling down several stairs. She was found to have a sagittal split fracture of the right C1 lateral mass extending into the posterior arch. The fracture was treated with a direct posterior osteosynthesis of C1 using lateral mass screws. CONCLUSION: Surgical management of unstable C1 fractures has traditionally involved posterior fusion of C1 to C2 or fusion from the occiput to C2. These fusion procedures can be quite functionally limiting...
February 14, 2018: JBJS Case Connector
https://www.readbyqxmd.com/read/29443806/hand-held-optical-coherence-tomography-monitoring-of-chemoresistant-retinoblastoma
#9
Kunal Malik, R Joel Welch, Carol L Shields
PURPOSE: Retinoblastoma (Rb) is a potentially fatal intraocular malignancy in children, and hand-held optical coherence tomography (HH-OCT) can assist in submillimeter detection and monitoring after treatment of Rb. Retinoblastoma located in the macula, or those with chemoresistance, can be among the most difficult to manage. We describe HH-OCT features in a case of chemoresistant macular Rb that eventually responded to plaque radiotherapy after failing intravenous chemotherapy and intraarterial chemotherapy...
February 13, 2018: Retinal Cases & Brief Reports
https://www.readbyqxmd.com/read/29443785/can-endotracheal-intubation-be-the-first-step-in-management-of-nonconvulsive-status-epilepticus-a-case-report
#10
Saad Warraich, Abbas Ali, Atif Nizami, Moiz Bakhiet
RATIONALE: Nonconvulsive status epilepticus (NCSE) is prolonged seizure activity without motor manifestations. Clinically, there are certain examination findings, in addition to elements of history, that help differentiate it from other encephalopathies. When diagnosing NCSE, the physician faces significant difficulties due to inconsistent clinical presentation and somewhat nonspecific electroencephalogram (EEG) criteria. PATIENT CONCERNS: To highlight the problems faced when dealing with such a patient, a case of a 29-year-old male who presented with an altered state of consciousness is put forth for the reader...
February 2018: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29443783/giant-gist-of-the-stomach-a-successful-case-of-safe-resection-with-preoperative-simulation-using-three-dimensional-ct-angiography-case-report
#11
Kentaro Matsuo, Masaya Inoue, Yasutsugu Shirai, Tatsuki Kataoka, Shuji Kagota, Kohei Taniguchi, Sang-Woong Lee, Kazuhisa Uchiyama
RATIONALE: We report a very rare case of safely resectable giant gastrointestinal stromal tumor (GIST) with preoperative three-dimensional computed tomography (3D-CT) angiography in spite of no neoadjuvant treatment. PATIENT'S CONCERN: A 71-year-old woman presented to our hospital with an abdominal giant tumor. As this giant tumor could not be accurately diagnosed by preoperative investigation, we had to perform her surgical treatment without neoadjuvant treatment...
February 2018: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29443738/hodgkin-lymphoma-involving-the-tonsil-misdiagnosed-as-tonsillar-carcinoma-a-case-report-and-review-of-the-literature
#12
You Qin, Lijuan Lu, Yanwei Lu, Kunyu Yang
RATIONALE: Primary Hodgkin lymphoma (HL) involving the tonsil is extremely rare. Only about 20 such cases with verification of biopsy and immunohistochemistry have been reported. Because of its rarity and unremarkable clinical presentation, a timely correct diagnosis is very challenging. PATIENT CONCERNS: A 43-year-old man complained left tonsillar enlargement and painless masses in left neck, with night sweat. The clinical examination found a marked tonsillar asymmetry, with an enlarged left tonsil and ipsilateral cervical lymphadenopathy and a normal right tonsil...
February 2018: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29443736/what-may-cause-fetus-loss-from-acute-pancreatitis-in-pregnancy-analysis-of-54-cases
#13
Min Tang, Jian-Ming Xu, Sha-Sha Song, Qiao Mei, Li-Jiu Zhang
Acute pancreatitis in pregnancy (APIP) poses a serious threat to the mother and her fetus, and might lead to fetal loss including miscarriage and stillbirth in certain patients. We sought to identify possible factors that affect fetal distress and evaluated outcomes of patients with APIP.We retrospectively reviewed clinical records of 54 pregnant women with APIP, who were treated at 2 tertiary clinical centers over a 6-year period. Clinical characteristics including etiology and severity of APIP, fetal monitoring data, and maternofetal outcomes were analyzed...
February 2018: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29443731/recovery-of-an-injured-corticofugal-tract-from-the-supplementary-motor-area-in-a-patient-with-traumatic-brain-injury-a-case-report
#14
Sung Ho Jang, Seong Ho Kim, Jeong Pyo Seo
RATIONALE: We report on a patient with traumatic brain injury who showed motor recovery concurrent with recovery of injured corticofugal tracts (CFTs), diagnosed by diffusion tensor tractography (DTT). PATIENT CONCERNS: Four weeks after onset, when the patient started rehabilitation, he showed severe weakness of both upper and lower extremities [Motricity Index (MI, full score: 100/100): 9/30]. DIAGNOSES: A 29-year-old male patient underwent conservative management for traumatic hemorrhages in both frontal lobes and right thalamus resulting from a car accident...
February 2018: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29443725/pediatric-anesthesia-after-the-anaesthesia-practice-in-children-observational-trial-study-who-should-do-it
#15
Walid Habre
PURPOSE OF REVIEW: This review highlights the requirements for harmonization of training, certification and continuous professional development and discusses the implications for anesthesia management of children in Europe. RECENT FINDINGS: A large prospective cohort study, Anaesthesia PRactice In Children Observational Trial (APRICOT), revealed a high incidence of perioperative severe critical events and a large variability of anesthesia practice across 33 European countries...
February 12, 2018: Current Opinion in Anaesthesiology
https://www.readbyqxmd.com/read/29443696/intravenous-lidocaine-for-intractable-renal-colic-unresponsive-to-standard-therapy
#16
Billy Sin, John Cao, David Yang, Karen Ambert, Sheena Punnapuzha
CLINICAL FEATURES: Renal colic is defined as a flank pain radiating to the groin caused by kidney stones in the ureter (urolithiasis). Renal colic is a frequent cause of Emergency Department visits. Most renal colic cases present as acute distress and severe back and/or abdominal pain that require prompt treatment with analgesics. THERAPEUTIC CHALLENGE: Nonsteroidal anti-inflammatory drugs and opioids are traditionally used for renal colic in the Emergency Department...
February 13, 2018: American Journal of Therapeutics
https://www.readbyqxmd.com/read/29442540/management-of-immune-related-adverse-events-in-patients-treated-with-immune-checkpoint-inhibitor-therapy-american-society-of-clinical-oncology-clinical-practice-guideline
#17
Julie R Brahmer, Christina Lacchetti, Bryan J Schneider, Michael B Atkins, Kelly J Brassil, Jeffrey M Caterino, Ian Chau, Marc S Ernstoff, Jennifer M Gardner, Pamela Ginex, Sigrun Hallmeyer, Jennifer Holter Chakrabarty, Natasha B Leighl, Jennifer S Mammen, David F McDermott, Aung Naing, Loretta J Nastoupil, Tanyanika Phillips, Laura D Porter, Igor Puzanov, Cristina A Reichner, Bianca D Santomasso, Carole Seigel, Alexander Spira, Maria E Suarez-Almazor, Yinghong Wang, Jeffrey S Weber, Jedd D Wolchok, John A Thompson
Purpose To increase awareness, outline strategies, and offer guidance on the recommended management of immune-related adverse events in patients treated with immune checkpoint inhibitor (ICPi) therapy. Methods A multidisciplinary, multi-organizational panel of experts in medical oncology, dermatology, gastroenterology, rheumatology, pulmonology, endocrinology, urology, neurology, hematology, emergency medicine, nursing, trialist, and advocacy was convened to develop the clinical practice guideline. Guideline development involved a systematic review of the literature and an informal consensus process...
February 14, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29442480/cushing-s-disease-major-difficulties-in-diagnosis-and-management-during-pregnancy
#18
Francisca Caimari, Rosa Corcoy, Susan M Webb
Pregnancy in women with a diagnosis of Cushing' syndrome (CS) is an extremely rare event and its diagnosis and treatment are a real medical challenge. During pregnancy, the hypothalamus-pituitary-adrenal axis undergoes major changes leading to a significant increase in plasma cortisol levels throughout gestation. The difficulties in diagnosis are related to the resemblance of symptoms of CS and those of pregnancy, and to the complex interpretation of the screening tests. Moreover, the diagnostic work up in the postnatal period may be difficult in the first weeks postpartum...
February 13, 2018: Minerva Endocrinologica
https://www.readbyqxmd.com/read/29442395/paediatric-thoracic-empyema-in-the-tropical-north-queensland-region-of-australia-epidemiological-trends-over-a-decade
#19
Anil Gautam, Gregory G Wiseman, Marika L Goodman, Simon Ahmedpour, Daniel Lindsay, Adele Heyer, Harry Stalewski, Robert E Norton, Andrew V White
AIM: The Townsville Hospital and Health Service is the regional referral centre for children in the north of Queensland. Aboriginal and Torres Strait Islander (ATSI) people make up 7-10% of the population. Increasing numbers of children with paediatric thoracic empyema (pTE) are being referred to Townsville Hospital and Health Service for management. This study aims to describe the incidence rates, epidemiology, microbiology and trends of this disease in North Queensland over a 10-year period...
February 14, 2018: Journal of Paediatrics and Child Health
https://www.readbyqxmd.com/read/29442194/-i-don-t-have-to-do-this-all-by-myself-systems-navigation-to-ensure-continuity-of-hiv-care-for-persons-leaving-prison
#20
Shannon M Fuller, Kimberly A Koester, Andres Maiorana, Wayne T Steward, Michelle R Broaddus, Katie Lass, Sophia Zamudio-Haas, Evelyn Byrd Quinlivan, Janet J Myers
Ensuring continuity of and retention in care after release from prison is critical for optimizing health outcomes among people living with HIV. As part of a large federal initiative, we conducted qualitative interviews (n = 24) with individuals living with HIV and recently released from prison in four states to understand their experiences in different navigation interventions to improve access to HIV care post-release. Interventions were delivered only in prison, only in the community, or in both settings...
February 13, 2018: AIDS and Behavior
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