Journal articles on the topic 'Safe Route Advisor'

The Safe Route Advisor System is a machine learning-based platform designed to enhance travel safety by recommending secure routes based on crime data analysis. Utilizing the k-means clustering algorithm, the system categorizes geographical areas based on crime incidence, enabling it to identify and suggest the safest paths among multiple route options. By considering user-defined preferences such as time constraints and desired destinations, the system provides tailored route recommendations that prioritize safety without sacrificing efficiency. This innovative approach showcases the potential of machine learning to improve travel safety and enhance the overall user experience. Future enhancements could include the integration of crime data, advanced clustering techniques, natural language processing for user interactions, and partnerships with navigation services for seamless route planning.

<p>文以醫療機構環境與基礎建設各系統現場訪視，採系統追蹤方式，從受訪2家醫療院所環境風險管理與火災風險辨識著手，以消防安全設施設備管理；各樓棟防火區劃完整度檢視；避難逃生路徑規劃與逃生方向指引；醫用氣體使用安全；危險物質儲存、使用、洩漏管理；用電與各機房環境安全及緊急災害應變措施機制等面向，重點檢視受輔導醫療機構設施設備與環境安全現況及安全脆弱點，提供醫療機構管理階層，提升病人就醫環境整體安全之參考。</p> <p> </p><p>This paper describes a systematic tracking approach for conducting on-site inspections at two medical facilities and assessing their institutional environments and infrastructure. The assessment centers on the management of environmental and fire risks, including overseeing fire safety facilities and equipment. The comprehensiveness of the fire zoning of individual buildings and the planning of and guidance to evacuation routes are evaluated. Also assessed are the safe use of medical gases, the management (including storage, use, and leakage) of hazardous substances, electrical safety, environmental safety in rooms with heavy machinery, disaster response, and emergency management. The primary objective is to scrutinize the safety vulnerabilities of the facilities and to critically evaluate the general environmental conditions at the two medical institutions, providing management teams with insights to enhance the safety of the health-care environment.</p> <p> </p>

Intersection management is a sophisticated event in the intelligent transportation system due to a variety of behavior for traffic participants. This paper primarily overviews recent studies on the scenes of intersection, aiming at improving the efficiency or guaranteeing the safety when vehicles pass the crossing. These studies are respectively surveyed from the perspectives of efficiency and safety. Firstly, recent contributions to efficiency-oriented, intersection management overviews from four scenes, including congestion avoidance, green light optimized speed advisory (GLOSA), trajectory planning, and emergency vehicle priority preemption control. Furthermore, the studies on intersection collision detection and abnormal information warning are surveyed in the safety category. The corresponding algorithms for velocity and route management presented in the surveyed works are discussed.

ABSTRACT On January 12, 2007 the MIV TONG CHENG, a 485 ft. Chinese flag break bulk vessel loaded with cargo and 130,000 gallons of oil, en route to the Panama Canal, notified Coast Guard Sector Honolulu that it had suffered damage to its #2 cargo hold and the hold was full of seawater. Located 700 miles from the nearest port (Honolulu), the vessel'S pumps were unable to keep up with the flooding, and with 26 personnel on board, the vessel advised it was diverting to Honolulu for emergency repairs. As the vessel proceeded toward Honolulu, its decreasing speed, the presence of two additional cargo ships in escort and the discovery of an oil sheen trailing the vessel raised significant concerns over the threat this posed to Hawaii. At stake in allowing the vessel a safe haven were the pristine shorelines of the Hawaiian Islands and potential crippling of the port'S vital lifeline to commercial marine traffic, its only source of sustenance. A myriad of issues had to be addressed as the vessel made preparations to come into Honolulu Harbor and a multi-agency, international Unified Command was established. The Unified Command, using the Incident Command System, managed the various contingencies from search and rescue of the crew if the ship were lost, to the potential discharge of 130,000 gallons of fuel. A risk-based decision process was employed to weigh the off-shore response challenges against the near-shore risks while taking into account the remoteness and sensitive marine environment of the Hawaiian Islands. This paper provides insight into the dynamic and complex response and the incident management teams decisions regarding allowing this vessel in distress to enter a critical and environmentally sensitive port. The vessel was successfully repaired and allowed to depart Hawaii. This case is a classic example of proper decision making and risk balancing for a critical safe refuge request.

Active Transportation to School (ATS) offers numerous health benefits and is considered an affordable option, especially in disadvantaged neighborhoods. The US Centers for Disease Control and Prevention (CDC) advises 60 min of daily physical exercise for children aged 6 to 17, making ATS a compelling approach to promote a healthier lifestyle among students. Initiated in 2005 by the US Department of Transportation (DOT), the Safe Routes to School (SRTS) program aims to foster safe and regular walking and biking to school for students. This paper examines students’ travel behavior using SRTS survey data and assesses the program’s effectiveness in promoting ATS in Chula Vista, California. Employing machine learning algorithms (random forest, logistic regression, and support vector machines) to predict students’ likelihood to walk to school, it utilizes SHAP (SHapley Additive exPlanations) to pinpoint significant variables influencing ATS across all models. SHAP underscores critical factors affecting transportation choices to school, highlighting the importance of home-to-school distance, with shorter distances positively impacting active transportation. However, only half of students within schools’ walking distance opted to walk to school, underscoring the necessity of addressing parental safety concerns, including factors such as crime rates and traffic speed along the route.

In maritime traffic, a route is one or more known tracks along which navigation takes place or there is intention to sail. Meteorological factors are important if the route exceeds the distance of 1500M [1]. Meteorological navigation is the selection of a navigational route in view of meteorological factors and control of vessel during heavy weather conditions and safe navigation aimed at the protection of human lives, vessels and cargo during heavy weather. The paper proposes a model of grouping and evaluating estimates of meteorological factors when planning meteorological navigation. It is advised to upgrade the Electronic Chart Display and Information System – ECDIS program with the aim of allowing for the computer planning of meteorological navigation. KEY WORDS: planning of navigation, meteorology, optimal route, Electronic Chart Display and Information System - ECDIS

The objective of this study was to examine the potential benefits for air traffic controllers from the use of automated weather advisories. In a part-task simulation, we used a weather support tool called Automatic Identification of Risky Weather Objects in Line of Flight (AIRWOLF) that (a) detects conflicts between aircraft and hazardous weather, (b) alerts the controller, and (c) generates automatic weather advisories. During the simulation, air traffic control (ATC) subject matter experts responded to AIRWOLF alerts and either provided weather advisories to pilots via radio in two main conditions or provided data link communication in a third control condition. Automated advisories (a) eliminate the need for a manual production of weather advisories; (b) reduce the production time, voice duration, and overall advisory duration; and (c) reduce the cognitive workload associated with the dissemination of weather advisories. The results showed that the AIRWOLF tool could support air traffic controller weather avoidance actions and provide accurate and timely weather advisories to pilots. The weather advisory tool could support en route controllers for the safe, efficient, and strategic efforts required to handle adverse weather conditions in the en route environment.

As I write, the Syrian migrant crisis is boiling over and the Arctic Circle has become the latest precarious route desperate Syrian refugees are braving in their pursuit of security and shelter. A young Syrian woman is interviewed on the Norwegian evening news. Earlier this year other members of her family had fled to Germany. She stayed in Syria, waiting to hear from them before setting out herself. When she finally managed to get a call through to her family, they recounted the humiliating agonies they had endured on their journey through Turkey and advised her to find another route. She decided to take the new migration route to Europe, the safer and less expensive Arctic route, as far as possible from the horrors of war. She doesn't go into the details of her long journey, other than to say that she has been hungry for a couple of years, often dizzy from hunger. As she is interviewed in the polar night, she stands in front of a building decorated with Christmas lights, a Bethlehem star in each of the windows, skinny pines covered in frost in the background, snow on the ground: “I don't mind that my ears are frozen and that I can see my breath. I want to be safe and have a dignified life. Get a proper education, work, and be able to feed myself.” The camera shows other Syrian families with young children, single men and women, and girls and boys, traveling alone. Volunteers from the “Refugees Welcome to Norway” (RWTN) association distribute warm clothes, nappies, prams, toys, coffee, tea, sandwiches, and traditional Christmas cakes.

Aiming at the characteristics of many crossroads and large slope of ground exits in Suzhou Underground Annular Channel, fire resistant shutters were advised to set as flexible compartment. The whole channel was divided into 6 smoke control sections by fire resistant shutters and exits and ventilation shafts. The schemes of smoke control and people evacuation were presented. Smoke flow in 6 fire scenes was simulated by FDS 4.0. The results show that fire smoke could be discharged to ground along planned route to ensure the safe evacuation of people and cars, and show that the smoke control schemes are reasonable and effective.

AbstractA 59-year-old male was diagnosed as carcinoma gallbladder around 1 year back and underwent radical cholecystectomy. He also received four cycles of chemotherapy. Now, he complained upper abdominal heaviness; positron emission tomography-computed tomography (PET-CT) was done which showed PET-avid 8.5 mm sized lymph node at aortocaval region. There was no safe route, so endoscopic ultrasound (EUS)-guided fine-needle aspiration (FNA) was advised. However, FNA was not possible without crossing inferior vena cava and further management depended on FNA report. The EUS-FNA was done, and cytopathological smears were consistent with metastatic adenocarcinoma. There was no complication.

Patients of bleeding disorders are repeatedly exposed to blood and blood products and are thus at an increased risk of acquiring transfusion associated infection which like HIV, Hepatitis B and Hepatitis C. It is recommended that all patients of bleeding disorders should be vaccinated against hepatitis B virus as early as possible. Hepatitis B vaccine is conventionally administered via intramuscular route. Intramuscular injections are to be avoided in patients of bleeding disorders for the risk of bleeding and hematoma formation. It is advised to vaccinate them via subcutaneous route. Few studies have been done to study the efficacy of subcutaneous route. The aim of this study was to measure the seroconversion and seroprotection after primary immunization with recombinant hepatitis B vaccine by subcutaneous route in patient with bleeding diathesis. Cases and controls were screened for HBsAg, anti HBc (total) and anti HBs and ALT. 30 patients of bleeding disorders and 30 patients of were vaccinated against hepatitis B using recombinant vaccine via subcutaneous route and intramuscular route respectively at 0, 1, 6 month interval. HBsAg, anti HBc (total), ALT and anti HBs titre were estimated one month after every dose of vaccine that is at 1, 2 and 7 month interval. . The dose (10µg in age <10, 20µg for>10yrs age) and schedule (0,1,6 months) was same in both the arms of study.A total of 24 cases received all three doses of the vaccine and the remaining 6 received only 2 doses. All 30 controls received 3 doses. Seroconversion was defined as anti-HBs titre≥1mIU/ml and seroprotection as anti HBs titre≥10mIU/ml. Seroconversion (anti HBs ≥1mIU/ml) was observed one month after first dose of hepatitis B vaccine in 19 out of 25 cases (76%) and all 30 controls (100%). The ‘p’ value obtained using 2 tailed Fischer exact test is significant at 0.0061. Seroprotection (anti HBs≥10mIU/ml) was observed one month after first dose of Hepatitis B vaccine in 14 out of 25 cases (56%) and 12 out of 30 controls (40%) and the difference is statistically insignificant (p=0.285). Geometric Mean Titre (GMT) at 1 month were 11.48 and 12.39 mIU/ml in s.c. and i.m. arm respectively. 100% seroconversion was achieved at 2 month after first dose of hepatitis B vaccine in both the study groups. Seroprotection was achieved in 18 of 19 (94.73%) cases and 29 of 30 (96.66) controls at 2 months after second dose of hepatitis B vaccine. GMT at second month were 217.38 and 196.12 mIU/ml in s.c. and i.m. arm respectively. 100% seroconversion was achieved after third dose of hepatitis B vaccine. GMT at 7 months after first dose of vaccine was 706 and 650 mIU/ml for cases and controls respectively. None of the cases or controls reported any side effects.Thus, this study demonstrate that (1) Subcutaneous route of hepatitis B vaccination using the conventional dose (10µg in age <10yrs and 20µg in >10yrs) of recombinant vaccine achieves seroconversion and seroprotection rates similar to that of intramuscular route. (2) Subcutaneous route is safe in patients of bleeding disorders. Based on these findings we recommend that all patients of bleeding disorders should be vaccinated against hepatitis B using a recombinant vaccine in the dose of 10µg for age <10 years and 20µg in age>10 years via subcutaneous route.

Background: Women who have sex with women (WSW) are at an increased risk of sexually transmitted infections (STIs) due to engagement in high-risk sexual behaviors. Safe sex practice is hence critical for the WSW. The aim of the study was to assess safe sex health behaviors and practices among WSW to inform sexual and reproductive interventions targeting this group in Tanzania.Methods: This study was cross-sectional descriptive and retrospective conducted in Dar-es-Salaam region, the largest commercial city in Tanzania. Study population included WSW aged 18 years and above who met inclusion criteria. Data was collected using focus group discussions, in-depth interviews, key informant interviews and life stories. Data analysis applied thematic analysis.Results: Few WSW reported practicing safe sex. WSW used condoms only when engaging in sex with men. Some WSW lacked information on availability of protective devices; while some WSW did not use of protection despite having information on availability of protective devices. Majority of WSW used good hygiene practice (cleaning body, vagina, mouth, and sex toys) before and after sex to prevent transmission of infections; and some WSW used pre- and post- exposure prophylaxes. Low access and high cost of protective devices, being in a monogamous relationship, low health risk perception, fear of developing cancer from using lubricants, and advise from health worker against using lubricants, were reasons given by WSW for not practicing safe sex.Conclusions: Given the current evidence of overlap between the homosexual and heterosexual populations in STI transmission, comprehensive education on potential routes of STI transmission among WSW is critical.

AbstractOcean state forecast (OSF) along ship routes (OAS) is an advisory service of the Indian National Centre for Ocean Information Services (INCOIS) of the Earth System Science Organization (ESSO) that helps mariners to ensure safe navigation in the Indian Ocean in all seasons as well as in extreme conditions. As there are many users who solely depend on this service for their decision making, it is very important to ensure the reliability and accuracy of the service using the available in situ and satellite observations. This study evaluates the significant wave height (Hs) along the ship track in the Indian Ocean using the ship-mounted wave height meter (SWHM) on board the Oceanographic Research Vessel Sagar Nidhi, and the Cryosat-2 and Jason altimeters. Reliability of the SWHM is confirmed by comparing with collocated buoy and altimeter observations. The comparison along the ship routes using the SWHM shows very good agreement (correlation coefficient > 0.80) in all three oceanic regimes, [the tropical northern Indian Ocean (TNIO), the tropical southern Indian Ocean (TSIO), and extratropical southern Indian Ocean (ETSI)] with respect to the forecasts with a lead time of 48 h. However, the analysis shows ~10% overestimation of forecasted significant wave height in the low wave heights, especially in the TNIO. The forecast is found very reliable and accurate for the three regions during June–September with a higher correlation coefficient (average = 0.88) and a lower scatter index (average = 15%). During other months, overestimation (bias) of lower Hs is visible in the TNIO.

Current pain treatment guidelines advise against providing analgesics for postoperative pain using intramuscular injections, as this generally provides poor pain relief. However, this route remains the most prevalent treatment method. Intravenous or epidural patient-controlled-analgesia methods reduce pain effectively but are expensive, labor intensive, and available to only a limited number of patients. We propose administering the analgesics using oral analgesics and have developed a simple protocol for treating postoperative pain by use of oral morphine. After a variety of orthopedic surgeries, patients were given “around-the-clock,” oral, immediate-release morphine. Efficacy of the treatment (pain scores and adverse effects) was assessed 24 ± 2 hours after surgery. Data were collected prospectively from 95 patients, who received an average of 61 ± 30 (SD) mg morphine. Average pain scores were 2.4/10 (± 1.4) at rest and 4.0/10 (± 1.4) during movement in bed. Nausea and vomiting, the most common adverse effects, were reported by 22 (23 percent) patients. Naloxone was not administered to any of the patients. Oral morphine given in the early postoperative time to patients after a variety of orthopedic surgeries was effective and safe.

ObjectivesOcean rowing is an extreme ultraendurance sport where individuals row unsupported across an ocean. This can mean months at sea in unpredictable and inhospitable conditions. The extreme physical and mental demands associated mean medical issues are common yet under researched, impacting the medical assistance provided.MethodsThe Talisker Whisky Atlantic Challenge provides a framework with safety protocols to create safer environments for athletes to attempt transatlantic crossings. Race logs, which record communication between rowers and safety teams, were anonymised and examined to create cumulative totals of medical issues requiring help and an incident timeline.ResultsDuty officers were notified of 65 medical complaints, 32% (n=21) requiring race doctors. Dermatological conditions were most common, accounting for 32% of complaints (n=21) and affecting 24% of rowers. Pressure sores and infections represented 43% and 38% of dermatological complaints respectively. Musculoskeletal injuries equalled 18% (n=12) of complaints, affecting 20% of rowers. Most cases were reported in weeks one and three, with 37% (n=24) of issues and 90% (n=10) of seasickness cases in week one. Hygiene and antibiotics were frequently advised management options.ConclusionConditions requiring race doctor input represent the most severe cases with the potential to deteriorate. Managing dermatological and musculoskeletal issues is vital throughout the race, while seasickness prophylaxis and education is essential in initial race stages. Infections are cause for concern, with gluteal pressure sores a potential route for secondary infections. Further research is required before evidence-based guidelines for management of health issues in ocean rowers can be introduced.

Background: Von Willebrand disease (VWD) is the most common inherited bleeding disorder, affecting 1% of the population, and characterized by deficient or defective von Willebrand factor (VWF). Among women with VWD, up to 80% have heavy menstrual bleeding (HMB), many of whom have depleted iron stores and iron deficiency anemia with reduced physical functioning, anxiety, depression, and poor quality of life. HMB is a serious problem causing significant health burden for those affected. The lack of effective therapies for menorrhagia is a major unmet healthcare need in women with VWD: in up to 30% desmopressin (DDAVP), combined oral contraceptives (COCs) hormones, or the recommended non-hormonal agent, tranexamic acid (Lysteda®, TA) may be ineffective or poorly tolerated. VWF concentrates, including plasma-derived VWF (pdVWF, Humate-P®) and recombinant VWF (rVWF, Vonvendi®) safely reduce bleeds in VWD, but few data exist on VWF use in menorrhagia, and no prospective trials are available to guide treatment. As rVWF has higher purity, potency, and a longer half-life than pdVWF, this phase III trial will compare rVWF with TA in reducing menorrhagia in women with type 1 VWD. Methods: This is an NHLBI-funded U01 phase III multicenter, prospective, randomized, crossover trial in to compare IV rVWF vs. po TA in reducing menorrhagia in type 1 VWD, clinicaltrials.gov, NCT02606045. Women with type 1 VWD, VWF:RCo<0.50 IU/dL and menorrhagia, defined as pictorial blood assessment chart score (PBAC)>100 in at least one of the last two cycles, are eligible. Exclusions include hypothyroidism, past thrombosis, and renal disease. Subjects are randomized to rVWF 40 IU/kg IV day 1 vs. TA 1300 mg po three times daily days 1-5 in each of two consecutive cycles. The order of treatment is determined by randomization: in Group 1, rVWF is given in cycles 1 and 2, and TA in cycles 3 and 4; while in Group 2, TA is given in cycles 1 and 2, and rVWF in cycles 3 and 4. A rescue dose day of rVWF 40 IU/kg may be given day 2 of cycles in which rVWF is given. The primary endpoint is a 40-point reduction in PBAC, a validated measure of menstrual loss, after 2 cycles. As rVWF is a greater burden (IV, cost), to show it is superior to TA, it should improve PBAC 40 points more from baseline than TA. Secondary endpoints are cycle severity, cycle length, QoL (SF-36, Ruta, CDC-HRQ0L-14, CES-D), and satisfaction survey. Treatment response will also be compared with VWF assays and VWF genotype. Safety is assessed by number of rescue doses, other bleeding, thrombosis, and allergic reaction. Our research hypothesis is that rVWF will be superior, producing a greater improvement, by at least 40 points, in PBAC, than TA. We also hypothesize that rVWF will be as safe, tolerable, and acceptable as TA, and that VWF assays and VWF genotype will predict response to treatment. A sample size of 60 (inflated to 66 for 5% attrition) will provide 84% power to detect a difference in improvement of 40 points between rVWF and TA. Analysis will be by intent-to-treat analyses, with a two-tailed alternative hypothesis with type 1 error rate of 0.05, a 4-period 2-group (AABB/BBAA) crossover design, and an estimated between-subject standard deviation (SD) of 63 points and within subject SD of 100 points. Results: A total of 442 potential subjects have been identified at 19 participating HTCs, of whom 33 (7.5%) are eligible, and 2 enrolled. The most common reason for ineligibility is use of an IUD (15.6%), COCs (9.4%), age <18 years (6.2%), pregnancy (6.2%), breastfeeding (6.2%), and VWF prophylaxis (3.1%). Nursing services have been contracted for weekend rVWF infusions. In-person site visits include hands-on web portal training, including a password-protected, FDA-validated data entry system, eSYSDM, use of real-time data form completion by tablet, infusion tracking and training, real-time cycle reporting, patient-training checklists, and protocol training and monitoring. Local gynecologists have been invited to refer potentially eligible patients. Discussion: In conclusion, rVWF is a high-purity VWF concentrate with a longer half-life than pdVWF. In this multicenter phase III trial, rVWF is being compared to the current non-hormonal standard, TA, to reduce menorrhagia in adult women with type 1 VWD. rVWF is safe and effective in prevention and treatment of bleeds, and this trial will determine if rVWF reduces menorrhagia to a degree sufficient to justify its IV route and cost. Disclosures Ragni: Sangamo: Research Funding; Alnylam/Sanofi: Consultancy, Research Funding; ICER: Consultancy; OPKO: Research Funding; Bioverativ/Sanofi: Consultancy, Research Funding; Bayer: Consultancy; Biomarin: Consultancy, Research Funding; Shire/Takeda: Consultancy, Other: Study drug; Spark Therapeutics: Consultancy, Research Funding. Seaman:Spark Therapeutics: Consultancy; Genentech: Consultancy; Bayer: Consultancy; Takeda: Consultancy. Sidonio:Novo Nordisk: Membership on an entity's Board of Directors or advisory committees; Genetech: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda-Shire: Membership on an entity's Board of Directors or advisory committees, Research Funding; Bioverativ: Membership on an entity's Board of Directors or advisory committees, Research Funding; Grifols: Membership on an entity's Board of Directors or advisory committees, Research Funding; Uniqure: Membership on an entity's Board of Directors or advisory committees; Kedrion: Research Funding; Octapharma: Membership on an entity's Board of Directors or advisory committees, Research Funding; Biomarin: Membership on an entity's Board of Directors or advisory committees. Kuriakose:Alexion: Consultancy, Honoraria, Speakers Bureau; Bayer: Consultancy. Malec:Hemostasis and Thrombosis Research Society: Membership on an entity's Board of Directors or advisory committees; Spark: Honoraria; Sanofi: Consultancy, Honoraria, Speakers Bureau; Bayer: Honoraria; CSL: Honoraria. Rodgers:AstraZeneca: Consultancy; Sanofi: Consultancy; Novartis: Consultancy; Octapharma: Consultancy; Pfizer: Consultancy. Wheeler:Shire: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novo Nordisk: Honoraria, Membership on an entity's Board of Directors or advisory committees; Octapharma: Honoraria, Membership on an entity's Board of Directors or advisory committees.

Abstract Abstract 776 Background: Waldenstrom's macroglobulinemia (WM) and related-disorders (Marginal Zone Lymphoma: MZL, and non immunoglobulin IgM lymphoplasmacytic lymphoma: LPL) are rare diseases Very few randomized trials were reported in this setting. Most commonly patients with WM are initially treated with an alkylating agent, such as chlorambucil (CBL) or with a nucleoside analogue such as fludarabine (F) or 2CdA, alone or in association with monoclonal antibody. Methods: WM1 study was a prospective international randomized open-label study that included patients with previously untreated WM MZL and LPL. At registration, patients were stratified as having WM, SLVL, or LPL, and were randomized in the two arms. The aim of the study was to compare the efficacy of oral CBL at a dose of 8 mg/m2 for 10 days every 28 days to a maximum of 12 cycles with oral F at a dose of 40 mg/m2 orally for 5 days every 28 days to a maximum of 6 cycles. 418 patients were enrolled into the study from 07/01 to12/09. 414 patients were included and 405 received at least one course of chemotherapy. There were 339 WM, 37 MZL and 38 LPL with a median age of 68 years (40-89). 207 patients were randomized in the F arm and 207 patients in the CBL arm. At inclusion, the median of haemoglobin (g/l), platelets (Giga/l), albumin (g/l) and beta 2 microglobulin (mg/l) were 9.9, 218, 37.1 and 3.47 respectively. Results: In intention to treat basis, the overall response rate (CR+PR) was 47.8 % in the F arm versus 38.6% in the CBL arm (p=0.06). With a median follow-up time of 35.9 months, the median of progression free survival time (PFS) and disease free survival (DFS) were statistically longer in the F arm: PFS 36.3m vs 27.1 m ( p=0.01) and DFS 38.3m vs 19. 9m (p= 0.0006). In WM group, factors influencing negatively PFS were CBL arm, albumin< 35g/l, platelets<100 G/l and age> 70 years. Main toxicity was haematological with 17/203 (8.3%) vs 18/203 (9%) of grade III- IV thrombocytopenia and 50/203 (24.6%) vs 39/202 (19.3%) of grade III-IV anemia in F and CBL arms respectively. Overall survival rate at 5 years was 61.4% [52.9;71.3] in CBL arm and 70.3% [62.7-78.8] in F arm (p=0.04) (Fig 1). Cumulative Incidence of second malignancies (solid tumors and haematological malignancies except Richter syndrome (RS)) was statistically higher in the chlorambucil arm (25 versus 8, p= 0.004) (Fig 2). The number of RS was 8 in F arm and 9 in CBL arm. Conclusion: F by oral route is a safe and effective ambulatory treatment in WM and close related disorders patients, even in the elderly and more effective than CBL with a duration of response over 3 years. An unexpected finding was a statistically higher number of second malignancies in the C arm and we cannot rule out an oncogenic role of CBL in this setting. Of note, we stress that it is the first time that a front- line treatment has a significant impact on overall survival in WM patients. Disclosures: Leblond: mundipharma: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; genzyme: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Tournilhac:Amgen: Research Funding; Mundipharma: Membership on an entity's Board of Directors or advisory committees; GSK: Membership on an entity's Board of Directors or advisory committees.

Abstract Background The role of lenalidomide for maintenance after myeloblative therapy and autologous stem cell transplant (ASCT) has been established based on the CALBG 100104 and IFM 2005-02 experience. Continuous low dose lenalidomide demonstrated a significant benefit in progression free survival (PFS), time to progression (TTP) in both trials and the CALBG trial also demonstrated a benefit in early overall survival. The benefit in PFS with lenalidomide is preserved in patients with high risk cytogenetics and in complete remission after ASCT. Proteaseome inhibitors (PI) have been studied after ASCT in a hybrid consolidation/maintenance model with a predefined course of bortezomib-based therapy, which was well tolerated and led to a significant improvement in response rates and in PFS. However long term proteasome inhibitor maintenance therapy has been limited by the route of administration. The combination of PIs and immunomodulatory agents (IMiDs) have a strong preclinical rationale, and their activity has been confirmed with high response rates in various combinations in both newly diagnosed and relapsed/refractory myeloma. MLN9708, an oral PI, may be more convenient as an oral therapy to be studied in the maintenance setting. Here we report preliminary data from a pilot study of the combination of MLN9708 and lenalidomide as maintenance therapy post ASCT. Methods This is a single arm phase II study with the primary objective to establish the safety and efficacy (PFS) of MLN 9708 (Ixazomib) and lenalidomide in the maintenance setting post ASCT. The secondary objectives were to evaluate the incidence of secondary primary malignancy, the best response rate (sCR/nCR/VGPR/PR), time to progression and time to next therapy. Patients must have undergone ASCT with melphalan as a preparative regimen within 12 months of initiation of induction for newly diagnosed myeloma. Patients started maintenance therapy 60-180 days post ASCT. Treatment consisted of 28 day cycles of oral MLN9708 4 mg on days 1, 8, 15, and oral lenalidomide 10 mg daily on days 1-28 with a dose increase to 15 mg after 3 months if tolerating well. Adverse events (AEs) were graded by NCI-CTCAE v4. Response was assessed by the modified International Uniform Response Criteria. Results A total of 16 patients have been enrolled with a median age of 60 years (range 51-74); 12/16 patients were male. 6 patients had ISS stage 1, 2 patients had stage II, 5 patients had stage III, and 3 had an unknown stage. 14 of the patients remain on trial, 2 patients have discontinued maintenance therapy. 1 patient with high risk disease, including del17p, del 13 discontinued due to rapidly progressive disease during cycle 2; 1 patient discontineud due to hospitalization for bilateral pneumonia. 3 patients had a treatment related SAE including 2 patients with PNA, 1 pt with G2 dehydration requiring hospitalization. 5 patients required a dose reduction in MLN9708 or lenalidomide due to G3/4 thrombocytopenia (n=2); dose delays for thrombocytopenia/neutropenia (n=3); one patient also had concurrent grade 3 rash. Hematologic toxicity included 3/16 patients with G3/4 thrombocytopenia, 9/16 with G1/2 thrombocytopenia, 5/16 patients with G3 neutropenia and 6/16 patients with G1/2 neutropenia. G3/4 drug-related non-hematologic AEs occurring in >1/16 of patients were limited to 2 patients with G3 creatinine elevation (in the setting of hospitalization for pneumonia). Additional non-hematologic G1/2 events included 9/16 patients with nausea, 5/16 with diarrhea, 9/16 with constipation, 4/16 with emesis, 6/16 patients with G1 rash; 1 pt with worsening of baseline G1 neuropathy. Conclusions The combination of MLN9708 and lenalidomide as maintenance therapy post ASCT for NDMM is a well-tolerated combination. 14/16 patients remain on study with only 1 patient discontinuing due to toxicity (pneumonia). The preliminary experience demonstrates the combination is safe, feasible and well tolerated with minimal toxicity and no unexpected toxicity. Disclosures: Shah: Celgene: Consultancy, Research Funding; Array: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Millenium: Consultancy, Research Funding; Onyx: Consultancy, Research Funding. Off Label Use: This abstract describes bortezomib + rituximab as 1st line induction therapy for patients with Waldenstrom macroglobulinemia. Thomas:Millenium: Research Funding; Novartis: Research Funding; Celgene: Research Funding; Immunomedics: Research Funding; Pharmacyclics: Membership on an entity’s Board of Directors or advisory committees; Onyx: Membership on an entity’s Board of Directors or advisory committees. Wang:Onyx: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Millennium: Research Funding; Pharmacyclics: Research Funding; Janssen: Research Funding; Novartis: Research Funding. Qazilbash:Otsuka Pharmaceuticals: Research Funding. Orlowski:Bristol-Myers Squibb: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding; Celgene: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding; Millennium: The Takeda Oncology Company: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding; Onyx: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding; Resverlogix: Research Funding; Array Biopharma: Honoraria, Membership on an entity’s Board of Directors or advisory committees; Genentech: Honoraria, Membership on an entity’s Board of Directors or advisory committees; Merck: Membership on an entity’s Board of Directors or advisory committees.

The use of opioids has grown substantially over the past two decades reaching the dimensions of a global epidemic. These drugs have effects on multiple levels of the endocrine system through mechanisms which are still not fully elucidated, and awareness of their endocrine sequelae is vital for all specialists prescribing or managing patients on them. Hypogonadism is the most well-recognised consequence of opioid use (prevalence 21–86%) which, however, may remain undiagnosed with potential adverse outcomes for the patients. Although less frequent, cortisol deficiency can also be found. Furthermore, there is a negative impact on bone health (with reduced bone mineral density and increased fracture risk) and occasionally hyperprolactinaemia, whereas the clinical significance of alterations in other hormones remains to be clarified. Discontinuation or reduction of the opioid and, in cases of chronic pain, consideration of alternative therapies for pain relief are potential management options. Hormonal replacement, especially when the above measures are not practically feasible, needs to be considered. Further studies are needed to clearly establish the prevalence of hormonal abnormalities with various regimes, doses and routes of opioids and to address reliably the long-term benefits and risks of hormonal treatment in patients on opioids. Until evidence-based, safe and cost-effective clinical guidelines become available, periodical assessment of the gonadal and adrenal function (particularly when relevant clinical manifestations are present) and evaluation of the bone health status are advised.

ABSTRACT Background: Cigarette smoking is one of the most widespread types of tobacco use all over the world, causing a huge number of untimely deaths. On contrary to cigarette smoking, dhumapana (herbal smoke inhalation) is one of the very unique routes of drug administration described by the ancient Acharyas. Aims and Objectives: The purpose of medicated dhumapana described in Ayurvedic treatises is prevention or management of vata-kapha disorders. Prayogika dhumapana is advised to be practiced regularly for health promotion and protection of our body. The present study was carried out to prepare prayogika dhumavarti (herbal cigarette) and explore the safety of prayogika dhumapana, by analyzing and comparing the chemical composition of its smoke to that of tobacco smoke. Materials and Method: Prayogika dhumavarti was prepared as per the classical text, with contents of eladi gana mentioned in Sushruta Samhita. Analytical tests were performed for various parameters, e.g. tar, nicotine, and polynuclear aromatic hydrocarbons for herbal as well as nonherbal cigarette. Results: The amount of tar in prayogika dhumavarti (herbal cigarette) was eight times lesser than the tobacco cigarette (nonherbal sample). The amount of carbon monoxide was found to be 4.0 ppm and 9.0 ppm, respectively; the amount of carbon dioxide was found to be 2281 ppm and 2702 ppm, respectively, in herbal and nonherbal samples. Conclusion: Hence, on laboratory analysis, prayogika dhumapana was found to be safe on some major parameters.

In the aviation industry, navigation has a crucial role in supporting the smooth running of flight routes to maintain the safety and security of air transportation. Perum LPPNPI Pekanbaru branch provides communication, Navigation, Surveillance, and Data Processing facilities to ensure flight safety, regularity, and comfort. One of the navigation facilities available at Perum LPPNPI Pekanbaru branch is the Doppler VHF-Omnidirectional Range (DVOR), an air navigation system control tool that can guide aircraft to land precisely at the destination airport by providing information in the form of azimuth or artificial bearing. This research aimed to analyze the care and maintenance system for DVOR equipment, and identify several potential problems that have arisen during the operation of DVOR equipment at Perum LPPNPI Pekanbaru branch. In this research, evaluations and observations were carried out to assess the level of DVOR maintenance in accordance with Advisory Circular CASR Part 171-12. This research focused on evaluating Corrective Maintenance Monitor (CMM) analysis on DVOR Selex Type-1150A equipment at Perum LPPNPI Pekanbaru Branch. DVOR is a critical air navigation system that requires effective corrective maintenance. The method used in the research is procedural analysis of equipment maintenance as in research conducted by Widasari Mutiara, this research also focused on CMM evaluation, identification of potential problems, and performance analysis to improve maintenance efficiency. Research adopted a qualitative research method with a descriptive approach, because the data collected is textual in nature. This research method involved CMM system inspection, equipment maintenance analysis, and interviews with engineering personnel. The research results provide insights for improving corrective maintenance procedures, and increasing the availability and reliability of the DVOR system. The implications of these findings support safe and reliable flight operations at Perum LPPNPI Pekanbaru Branch.

Introduction: We describe a Phase I dose escalation study (NCT03081910) of autologous CD5-directed chimeric antigen receptor T cell (CD5 CAR T) therapy for relapsed or refractory (r/r) T-cell leukemia and lymphoma. Establishing a CAR T cell platform to target neoplasms of T-cell origin has been hindered by the shared expression of most targetable antigens on both malignant and normal T lymphocytes, which can promote CAR T cell fratricide. CD5 is one such pan-T cell surface marker present in ~85% of T-cell malignancies. We developed a second-generation CD5-specific CAR with CD28 costimulatory endodomain that produces minimal and transient fratricide when expressed in T cells. We designed this study to evaluate the safety and feasibility of treating patients with r/r T-cell malignancies with these CD5 CAR T cells as a bridge to allogeneic hematopoietic stem cell transplant (HSCT). Secondary objectives of our study included evaluating the antitumor response, in vivo expansion, persistence of CD5 CAR T cells, as well as their impact on normal T-cell numbers and function. Patients and methods: CD5 CAR T cells were generated from autologous PBMCs using gammaretroviral transduction and cryopreserved. We detected no residual malignant cells in the CD5 CAR T cell products by flow cytometry. To date, we have treated a total of 9 patients (8 adults and 1 adolescent; age 16-71 years [median 62 yrs]) with CD5+ r/r T-acute lymphoblastic leukemia (T-ALL; n=4) or T-non-Hodgkin's lymphoma (T-NHL; n=5) on dose levels 1 and 2. All patients were transplant-eligible with an identified allogeneic HSCT donor, yet unable to proceed due to residual disease. All patients had been heavily pretreated, with a median of 5 (range 2 -18) prior lines of therapy. Two patients had previously failed allogeneic HSCT. Patients received cytoreductive chemotherapy with cyclophosphamide and fludarabine followed by a single dose of CD5 CAR T cells. We evaluated adverse events, clinical responses, and in vivo expansion and persistence pre and post-infusion. Results: Three patients received CD5 CAR T cells on dose level 1 (1x107 CAR T cells/m2) and 6 on dose level 2 (5x107 CAR T cells/m2). In all patients treated, CAR T cells reached peak expansion in peripheral blood (PB) 1-4 weeks following infusion, followed by a gradual contraction in most patients (Figure 1). CD5 CAR T cells were present in lymph node and marrow biopsies in patients with T-NHL and T-ALL, respectively, and were also detected in a CSF sample in 1 T-ALL patient. After cytoreduction and CAR T cell infusion, we observed decreased PB CD3+ cell numbers but this ablation was never complete. Cytokine release syndrome (CRS) occurred in 3/9 patients (all at dose level 2). Grade 1 CRS was observed in 2 patients. One patient experienced Grade 2 CRS and Grade 2 neurotoxicity, which resolved after administration of tocilizumab and supportive care, respectively. Two patients had prolonged cytopenias at 6 weeks, 1 of whom had viral reactivation (CMV and BK virus) requiring antiviral therapy. On disease re-evaluation 4-8 weeks post-CD5 CAR T cell infusion, 4 of 9 evaluable patients obtained an objective response (1 of 3 on DL1 and 3 of 6 on DL2). Complete responses (CR) were achieved in 3 patients, one with angioimmunoblastic T cell lymphoma (AITL), one with peripheral T cell lymphoma (PTCL), and one with T-ALL. Two of these patients did not wish or were unable to proceed to planned HSCT and relapsed with their underlying CD5+ malignancy at 6 weeks and 7 months post-infusion. The remaining patient is currently undergoing work-up for HSCT (Figure 2). An additional patient with extensive AITL was classified as a mixed response (Figure 3) due to the appearance of a new PET-avid lesion. This patient received a second infusion of CD5-CAR T cells, proceeded to HSCT, and remains in CR at 125 days post-transplant. Conclusions: These results demonstrate that CD5 CAR T cells are safe and can induce clinical responses in heavily treated patients with r/r CD5+ T-ALL and T-NHL without inducing complete T-cell aplasia. Importantly, elimination of malignant T cells by CD5 CAR T cells may allow previously ineligible patients to proceed to HSCT. Disclosures Rouce: Novartis: Consultancy, Honoraria; Tessa Therapeutics: Research Funding; Kite, a Gilead Company: Consultancy, Honoraria. Grilley:Allovir: Consultancy, Equity Ownership; Marker Therapeutics: Consultancy; Tessa: Consultancy. Heslop:Marker Therapeutics: Equity Ownership, Membership on an entity's Board of Directors or advisory committees; Allovir: Equity Ownership; Gilead Biosciences: Membership on an entity's Board of Directors or advisory committees; Kiadis: Membership on an entity's Board of Directors or advisory committees; Tessa Therapeutics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Cell Medica: Research Funding. Brenner:Allovir: Equity Ownership, Membership on an entity's Board of Directors or advisory committees; Marker Therapeutics: Equity Ownership; T Scan: Membership on an entity's Board of Directors or advisory committees; Tessa Therapeutics: Equity Ownership; Memgen: Membership on an entity's Board of Directors or advisory committees; Allogene: Membership on an entity's Board of Directors or advisory committees.

BackgroundDiphtheria is a life threatening but vaccine preventable disease. 5 cases were identified by Public Health England (PHE) in 2017.1 Respiratory diphtheria is characterised by a pseudomembrane which obstructs the airways. Corynebacterium diphtheria produces an exotoxin that causes local tissue necrosis, myocarditis, polyneuropathy, paralysis, respiratory failure and death.Clinical caseA 4 year old boy was admitted via A&E with suspected croup requiring intubation and ventilation on intensive care unit (ICU). Throat swabs confirmed diphtheria diagnosis, PHE was contacted and diphtheria antitoxin was obtained. The patient received two subcutaneous doses of diphtheria-antitoxin. He developed myocarditis, Acute Kidney Injury (AKI), impaired left ventricular function and polyneuropathy. He was treated with 14 days intravenous vancomycin and clindamycin following multiple antibiotic changes.Pharmacy contributionAnti-toxin: Diphtheria anti- toxin was obtained and advice was provided regarding an appropriate dose and route of administration. Ward staff were reluctant to give a subcutaneous infusion. A pharmacist provided reassurance that this was the only way to treat the infection and a subcutaneous cannula was inserted. He was given 0.2 ml subcutaneously as a test dose followed by the remaining 40,000 units. His second dose was given as a test dose of 0.2 ml followed by 60,000 units between two sites due to multi-organ involvement. Chemoprophylaxis: The patient’s family and 34 staff members required prophylactic antibiotics. They received azithromycin 500 mg once daily for 3 days. Staff members had throat swabs and were to remain off work until these swabs were negative which resulted in the Trust cancelling elective operations and admissions. Pharmacy confirmed azithromycin was safe for 34 adult patients and checked for interactions with currently prescribed medicines and advised appropriately.Critical careCreatinine doubled and the pharmacist reviewed drugs to account for renal impairment. The pharmacist highlighted that clarithromycin can prolong QT interval. An echocardiogram revealed the patient had prolonged QT interval and clarithromycin was switched to an alternative after discussion with the microbiologist.Vancomycin therapeutic levels were reached on day 5. The dose remained unchanged for the remainder of the course and levels taken every 3 days were appropriate. The pharmacist prepared a weaning plan for morphine and clonidine. The pharmacist advised reducing dexamethasone and stopping when no longer required due to raised blood glucose measurements.Lessons learnedHow to obtain and administer diphtheria antitoxin. What chemoprophylaxis to provide to family and staff, the difficulties of supplying this to so many adults in a children’s hospital and the pressure the hospital faced having 34 staff members excluded for 48 hours while cultures were taken The importance of personal protective equipment to protect staff and other patients Monitoring parameters: vancomycin levels, renal function, cardiac function, blood sugars Importance of encouraging parents to have their children vaccinated with all the primary immunisations to protect their children and othersReferencePublic health England: Diphtheria in England 2017. Accessed via: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/711453/hpr1818_dphthr17.pdf

Volcanic ash can interact with the earth system on many temporal and spatial scales and is a significant hazard to aircraft. In the event of a volcanic eruption, fast and robust decisions need to be made by aviation authorities about which routes are safe to operate. Such decisions take into account forecasts of ash location issued by Volcanic Ash Advisory Centers (VAACs) which are informed by simulations from Volcanic Ash Transport and Dispersion (VATD) models. The estimation of the time-evolving vertical distribution of ash emissions for use in VATD simulations in real time is difficult which can lead to large uncertainty in these forecasts. This study presents a method for constraining the ash emission estimates by combining an inversion modeling technique with an ensemble of meteorological forecasts, resulting in an ensemble of ash emission estimates. These estimates of ash emissions can be used to produce a robust ash forecast consistent with observations. This new ensemble approach is applied to the 2011 eruption of the Icelandic volcano Grímsvötn. The resulting emission profiles each have a similar temporal evolution but there are differences in the magnitude of ash emitted at different heights. For this eruption, the impact of precipitation uncertainty (and the associated wet deposition of ash) on the estimate of the total amount of ash emitted is larger than the impact of the uncertainty in the wind fields. Despite the differences that are dominated by wet deposition uncertainty, the ensemble inversion provides confidence that the reduction of the unconstrained emissions (a priori), particularly above 4 km, is robust across all members. In this case, the use of posterior emission profiles greatly reduces the magnitude and extent of the forecast ash cloud. The ensemble of posterior emission profiles gives a range of ash column loadings much closer in agreement with a set of independent satellite retrievals in comparison to the a priori emissions. Furthermore, airspace containing volcanic ash concentrations deemed to be associated with the highest risk (likelihood of exceeding a high concentration threshold) to aviation are reduced by over 85%. Such improvements could have large implications in emergency response situations. Future research will focus on quantifying the impact of uncertainty in precipitation forecasts on wet deposition in other eruptions and developing an inversion system that makes use of the state-of-the-art meteorological ensembles which has the potential to be used in an operational setting.

Abstract von Willebrand factor (VWF) is a large multimeric glycoprotein secreted from platelet α-granules and Weibel-Palade bodies of endothelial cells. VWF mediates the initial adhesion of platelets at sites of vascular injury and binds to and stabilizes blood coagulation factor VIII in the circulation to protect it from inactivation and clearance. von Willebrand disease (VWD) is the most common hereditary bleeding disorder and results from the deficiency or dysfunction of VWF leading to mucocutaneous bleeding, including epistaxis, menorrhagia, and excessive bleeding after trauma or surgery. Bleeding in patients with VWD is treated with infusion of plasma-derived VWF containing FVIII concentrates or 1-desamino-8-D-arginine vasopressin (DDAVP, desmopression). DDAVP is an analog of vasopressin antidiuretic hormone which can stimulate the exocytosis of VWF from storage sites and increase VWF and FVIII levels. DDAVP can be administrated by intravenous and intranasal routes. There are several reports of the safety and efficacy of intravenous DDAVP, but few with concentrated intranasal DDAVP (Stimate®). Here we report on the efficacy and safety of Stimate® in patients with VWD Methods Hospital records for 72 patients with VWD who received Stimate® from 1998 to 2012 were reviewed. The primary endpoint was the patients’ biological response to Stimate®, defined as at least a 3 fold increase compared to baseline of both ristocetin cofactor activity (VWF:RCo), factor VIII procoagulant activity (FVIII:C), or both VWF:RCo and FVIII:C are over 100% after Stimate®. Individuals not meeting the response criteria were deemed to be nonresponse. The adverse events were analyzed between different VWD types, response, age, gender, and race. Result Of those 72 VWD patients, 45 have type 1 (62%), 7 have type 2 (10%), and in 20 cases the subtype was unclear (28%). Responsive to Stimate® was observed in 43 (95.6%) of type 1, 4 (57.1%) of type 2, and 19 (95%) in which the diagnosis was unclear. In total, 16 patients (22.2%) had adverse events: 1 – allegoric response, 8 - mild headache, 4 - mild hyponatremia, and 4 - blood pressure (BP) reduced more than 20 mmHg. Conclusion Patients with VWD 1 have higher response rates to Stimate® than patients with VWD 2 in our test. The Stimate® is effective and safe for treatment of VWD. Disclosures: Valentino: Baxter, Bayer, Biogen Idec, GTC Biotherapeutics, Inspiration Biopharmaceuticals, Novo Nordisk: Consultancy, Membership on an entity’s Board of Directors or advisory committees.

Abstract Introduction Failure to respond to steroid therapy for intestinal acute graft-versus-host disease (aGvHD) is associated with limited further therapeutic options. Fecal microbiotherapy is defined as the perfusion of treated stool from one or several healthy donors via the upper or lower gastrointestinal (GI) route aiming at improving microbial diversity and functionality. Here we report clinical outcomes from a 76-patient cohort with steroid refractory (SR) GI-aGvHD treated with the pooled allogenic fecal microbiotherapeutic MaaT013. Twenty-four patients were treated in the prospective, single-arm, phase IIa, HERACLES study (NCT03359980) while 52 patients were treated in an expanded access program (EAP). Patients and methods For HERACLES, 24 patients with grade III-IV SR-GI-aGvHD were treated with MaaT013 in 26 European sites, as a 2 nd line therapy after SR diagnosis and evaluable for treatment response. In EAP, 52 patients with steroid-dependent or SR-GI-aGvHD (classical n=41, late onset n=3, overlap syndrome n=8) were treated. These patients had previously received and failed 1 to 6 lines (median 3; 40/52 received ruxolitinib) of GvHD systemic treatments. GI-GvHD response was evaluated weekly and 28 days after day (D) 0 (inclusion for HERACLES or 1st dose for EAP). For all patients, GI-overall response rate (ORR) at D28 was defined as the proportion of patients achieving complete response (CR), very good partial response (VGPR) or partial response (PR), compared to D0, without the use of additional systemic therapy. Other endpoints included the best overall response (BOR) achieved at any time, and overall survival (OS). Prepared under GMP, MaaT013 is characterized by a highly consistent richness of 455 ±3% OTUs and an Inverse Simpson index > 20. Treatment comprised 3 MaaT013 doses, each composed of 30 g of feces in 150 mL volume of inoculum (total 90 g of feces from 4 to 8 healthy donors) administered by enema (except for 2 EAP patients by nasogastric tube). All patients received at least 1 MaaT013 dose, 92% (HERACLES) and 87% (EAP) at least 2 doses, and 50% (HERACLES) and 71% (EAP) the full treatment course. In HERACLES, the reasons for not applying the 3 rd dose were death (n=5), physician decision to introduce salvage therapy (n=5), and ICU hospitalization (n=2)). Results In HERACLES, the GI-ORR was 38% including 5 CR, 2 VGPR and 2 PR. In EAP, positive GI-response was achieved in 31/52 patients (60% with 16 CR, 11 VGPR and 4 PR). Considering the GI-BOR, 13/24 (54%) and 35/52 (67%) achieved at least a PR in HERACLES and EAP respectively. In HERACLES, OS was 29% at month (M) 6 and 25% at M12. OS was significantly higher in responding (R) patients (achieving at least PR at D28) compared to non-responding (NR) (44% vs 20% at M6 and 44% vs 13% at M12, logrank p=0.047). In EAP, OS was 48% at M6 and 37% at M12, and significantly higher in R patients compared to NR (71% vs 17% at M6 and 62% vs 6% at M12, logrank p<0.0001). In HERACLES, treatment with MaaT013 was characterized by excellent tolerance: 252 Treatment-Emergent Adverse Events (TEAE) were reported for the 24 patients, the majority being infections (79%) and GI disorders (62%), as expected in GvHD patients. Of these 252 TEAE, only 2% (5 serious events in 2 patients) could not reasonably be excluded from being related to MaaT013 by the investigators. Shotgun sequencing in these 5 TEAE revealed that the causative infectious agents could not be detected in the administered MaaT013. In EAP, the safety profile of MaaT013 was considered satisfactory for all patients. 16S microbiome analyses were performed in the HERACLES population and showed that MaaT013 produced an early increase in α-diversity at genus level with a significant increase in Richness index at all evaluated timepoints (p <0.003). At D28, R patients had higher values of α-diversity indices (Shannon p=0.005 and Richness p=0.038) compared to NR patients, and higher proportions of MaaT013-derived species in the total composition of R microbiota (p=0.043). Conclusion We herein report the treatment of 76 SR-GI-aGvHD patients using a full ecosystem, pooled-donor, high-richness biotherapeutic. The D28 GI-ORR was 38% and 60% in HERACLES and EAP respectively and this clinical benefit positively and significantly impacted OS (44% and 62% M12 in HERACLES and EAP R patients respectively). MaaT013 was shown to be safe and effective in these heavily immunocompromised patients, warranting further exploration of this approach. Figure 1 Figure 1. Disclosures Malard: JAZZ pharmaceuticals: Honoraria; Sanofi: Honoraria; Astellas: Honoraria; Biocodex: Honoraria; Therakos/Mallinckrodt: Honoraria; Janssen: Honoraria. Loschi: CELGENE/BMS: Honoraria; AbbVie: Ended employment in the past 24 months, Honoraria; Gilead: Ended employment in the past 24 months, Honoraria; Novartis: Ended employment in the past 24 months, Honoraria; Servier: Ended employment in the past 24 months, Honoraria; MSD: Honoraria. Cluzeau: Agios: Honoraria; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: travel, accommodations, expenses, Speakers Bureau; Roche: Consultancy, Honoraria; BMS/Celgene: Consultancy, Honoraria, Speakers Bureau; Jazz Pharma: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria, Speakers Bureau; Amgen: Speakers Bureau; Pfizer: Other: travel, accommodations, expenses; Astellas: Speakers Bureau; Takeda: Other: travel, accommodations, expenses. Huynh: Jazz Pharmaceuticals: Honoraria. Holler: MaaT Pharma: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. Vehreschild: SocraTec R&D GmbH: Consultancy, Speakers Bureau; Pfizer: Consultancy, Speakers Bureau; Ferring: Consultancy, Speakers Bureau; Farmak International Holding GmbH: Consultancy, Honoraria, Speakers Bureau; Bio-Mérieux: Consultancy, Speakers Bureau; Basilea: Consultancy, Speakers Bureau; Arderypharm: Consultancy, Speakers Bureau; Alb Fils Kliniken GmbH: Consultancy, Speakers Bureau; Takeda Pharmaceutical: Research Funding; Seres Therapeutics: Research Funding; Roche: Consultancy, Research Funding, Speakers Bureau; Organobalance: Consultancy, Research Funding, Speakers Bureau; Merck/MSD: Consultancy, Research Funding, Speakers Bureau; MaaT Pharma: Consultancy, Research Funding; Immunic AG: Consultancy, Research Funding, Speakers Bureau; Glycom: Research Funding; Gilead Sciences: Consultancy, Research Funding, Speakers Bureau; Evonik: Research Funding; Da Volterra: Consultancy, Research Funding, Speakers Bureau; Biontech: Research Funding; Astellas Pharma: Consultancy, Research Funding, Speakers Bureau; 3M: Research Funding. Gasc: MaaT Pharma: Current Employment. Plantamura: MaaT Pharma: Current Employment. Mohty: Sanofi: Honoraria, Research Funding; Pfizer: Honoraria; Novartis: Honoraria; Takeda: Honoraria; Jazz: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Gilead: Honoraria; Celgene: Honoraria, Research Funding; Bristol Myers Squibb: Honoraria; Astellas: Honoraria; Amgen: Honoraria; Adaptive Biotechnologies: Honoraria.

An increasingly intensive activity has been noticed recently at the international level with regard to the implementation of United Nations Security Council Resolution 1325 and associated resolutions. More and more international events regarding women, peace and security are being organised every year, education and training programmes as well as a conceptual framework of the gender perspective are being developed, and system solutions in both international organisations and national structures are being put forward. One of such solutions is the appointment of ambassadors for women, peace and security, as well as of gender advisors on gender perspective. Last year, a full-time advisor position in this field was set up at the General Staff of the Slovenian Armed Forces. Being a subject matter expert for the area of gender perspective in the Slovenian Armed Forces, I am pleased that the importance of the agenda regarding women, peace and security has been recognised and that a publication has been issued at the academic level by involving experts and gaining support from the leadership. I am grateful to my international colleagues for their papers, for having kindly responded to the invitation to share their views, solutions and experiences with us. This is indeed the main value of this publication: sharing is caring. The set of topics demonstrates to what extent the Resolution and the gender perspective are implemented, ranging from the international level, through national solutions and to the realisation in international operations and missions. Although Resolution 1325 is extensively explained in individual papers, I would like to introduce several key factors linking the Resolution and the gender perspective, to proffer a better understanding of the topic and emphasise why the integration of the gender perspective is vital for both Slovenian and international landscape. The basis for this discussion are conceptual solutions of international organisations and my participation in the NATO Committee on Gender Perspectives. Actions like this are vital for they aim to develop the said area and encourage new ways of thinking,thereby highlighting compound gender-related topics and informing the practices of Slovenian Armed Forces. Resolution 1325 is a milestone for the role of women in conflict prevention and resolution, in peace processes, humanitarian response and in post conflict reconstruction. It underlines three interlinking factors, i.e. women, peace and security. There is no security without peace, and no peace without a safe and secure environment. Moreover, there is no peace and security without addressing the entire population. In the past, women were frequently excluded from peace processes. If solely one perspective is included, the expected result can be partial. In 15 years since the adoption of Resolution 1325, the increased asymmetric threats in a complex security environment have resulted in the need for more comprehensive approaches to ensure security and peace around the world. During this time, many facts which were ignored in the past have been seriously discussed at the international level with the aim of finding solutions. Armed conflicts and the post-conflict period affect women differently than men. Boys and girls too are affected differently, in relative terms. Importantly, acts of men and women in such circumstances can be either different or the same, but due to socially constructed perceptions they are accepted differently. More particularly, it should be stressed that socially constructed is their gender, which is a concept that this introduction defines as social and cultural characteristics associated with a given sex (whereas sex refers to biological differences between males, females, and intersex persons, and is assigned at birth). Gender as such materialises in our reality: for example, while during armed conflicts the majority of men are recruited for combat tasks, women stay at home with children or are forced to leave their homes. That is why they make up the majority of internally displaced persons and refugees both on refugee routes and in refugee camps. Their safety is compromised in such circumstances; they are often targeted by groups of combatants, kidnapped, enslaved or abused. It should also be noted that girls and boys are not exposed in the same way: girls can be subject to pre- mature and forced marriages, boys to early recruitment into combatant groups. As regards the general recognition of the role of men and women in armed conflicts and beyond, the most common perception is of women as victims and men as combatants. However, the truth is that women also are combatants and strong actors for peace, and men are victims of intentionally committed acts. Furthermore, a serious problem in contemporary conflicts is sexual and gender-based violence. This is an alarming issue. This form of violence is predominantly inflicted against women, although also girls, boys and men suffer from it, either in the form of torture or as a weapon of war. It could be said that the gender perspective in relation to international operations and missions has, on the one hand, developed for the purpose of implementing Resolution 1325 and, on the other hand, resulted from militaries’ experiences. Central to the gender perspective in international operations and missions is making women’s and men’s experiences and concerns integral to operation processes, whilst taking into account the different security-related situations these individuals face in line with their gender. As it has been argued, there is evidence that women and men, boys and girls, face different security risks - a process underpinned by the way their masculinities and femininities are perceived in a given culture and society, i.e. gender. Being able to recognise and understand the entire security situation as broadly as possible is crucial for operational effectiveness. Recognising the routes of women, which are usually different from routes used by men due to their individual gender roles, can affect the execution of an operation. Such information influences the provision of security, force protection and operational success. Therefore, the integration of the gender perspective into every process at all levels and in every stage of action is of extreme importance; comprehensive information on situation in the area of operation contribute to decisions of those in command. Experiences gained in international operations and missions have led to observations on certain limitations in the execution of tasks, particularly at the tactical level, for example as regards the exclusion of women from the local environment, particularly in those areas of operation where women are not allowed to communicate publicly with unknown men and where the structure and personnel are predominantly male. The inclusion of the gender perspective into task accomplishment has thus become a necessity to which international organisations, such as UN, NATO, the EU and other have drawn attention. In their structures, the contemporary armed forces need both female and male members at all levels and on different duties. This holds true for the fulfilment of tasks in international operations and missions and for the execution of tasks in domestic environment. International organisations tend to increasingly emphasize the importance of the inclusion of women into all structures; however, questions regarding women in armed forces keep appearing in the military, particularly as regards gender equality, physical performance of women and removal of restrictions in relation to the fulfilment of certain duties for women. There are growing tendencies to implement the gender equality principle, whereby a risk of equating equality with sameness may appear in the militaries. However, to perceive equality as sameness can lead to unilateral or too general solutions. Concerns, for example, that taking into account the biological differences between men and women in setting the standards could mean lower criteria and poorer performance actually lead to more important question: are standards really defined according to the requirements of individual duties or are they too general, and are they also established on the basis of the inclusion of gender perspective? It is crucial to understand that different tasks require different competences and preparedness of an individual. Indeed, the truth is that men and women will never be the same. There is variety between males and females which should be recognised as an advantage and not as a weakness. Failing to include the spectrum of gender, the wholeness cannot be reached; the inclusion of both male and female perspective on the same issue leads to integrity by bringing together the diversity. Due to changing security environment, we all are faced with new challenges, requiring even stronger networking of organisations both at the national and international levels in order to ensure comprehensive and effective solutions. Meteorological changes causing large-scale destruction call more often for the engagement of the armed forces in search and rescue tasks. Last year, mass migration from conflict zones, the Middle East and Africa to Europe required the involvement of the armed forces into tasks at home. Similarly as in fulfilling the tasks in international operations and missions, the armed forces and other government and non-government organisations dealing with refugees and migrants were faced with different cultures, where socially determined roles of men and women have great significance. Such circumstances promote further knowledge about the integration of gender perspective in new directions. The fundamental fact that the society is made up of women and men, girls and boys, remains, just as the diversity which, in its integrity, should bring us all towards ensuring security and peace. I wish you a pleasant reading of papers hoping they will help broaden new horizons and encourage new thoughts.

Welcome to the third issue of volume 43 of the IASSIST Quarterly (IQ 43:3, 2019).
 Yes, we are open! Open data is good. Just a click away. Downloadable 24/7 for everybody. An open government would make the decisionmakers’ data open to the public and the opposition. As an example, communal data on bicycle paths could be open, so more navigation apps would flourish and embed the information in maps, which could suggest more safe bicycle routes. However, as demonstrated by all three articles in this IQ issue, very often research data include information that requires restrictions concerning data access. The second paper states that data should be ‘as open as possible and as closed as needed’. This phrase originates from a European Union Horizon 2020 project called the Open Research Data Pilot, in ‘Guidelines on FAIR Data Management in Horizon 2020’ (July 2016). Some data need to be closed and not freely available. So once more it shows that a simple solution of total openness and one-size-fits-all is not possible. We have to deal with more complicated schemes depending on the content of data. Luckily, experienced people at data institutions are capable of producing adapted solutions. 
 The first article ‘Restricting data’s use: A spectrum of concerns in need of flexible approaches’ describes how data producers have legitimate needs for restricting data access for users. This understanding is quite important as some users might have an automatic objection towards all restrictions on use of data. The authors Dharma Akmon and Susan Jekielek are at ICPSR at the University of Michigan. ICPSR has been the U.S. research archive since 1962, so they have much practice in long-term storage of digital information. From a short-term perspective you might think that their primary task is to get the data in use and thus would be opposed to any kind of access restrictions. However, both producers and custodians of data are very well aware of their responsibility for determining restrictions and access. The caveat concerns the potential harm through disclosure, often exemplified by personal data of identifiable individuals. The article explains how dissemination options differ in where data are accessed and what is required for access. If you are new to IASSIST, the article also gives an excellent short introduction to ICPSR and how this institution guards itself and its users against the hazards of data sharing.
 In the second article ‘Managing data in cross-institutional projects’, the reader gains insight into how FAIR data usage benefits a cross-institutional project. The starting point for the authors - Zaza Nadja Lee Hansen, Filip Kruse, and Jesper Boserup Thestrup – is the FAIR principles that data should be: findable, accessible, interoperable, and re-useable. The authors state that this implies that the data should be as open as possible. However, as expressed in the ICPSR article above, data should at the same time be as closed as needed. Within the EU, the mention of GDPR (General Data Protection Regulation) will always catch the attention of the economical responsible at any institution because data breaches can now be very severely fined. The authors share their experience with implementation of the FAIR principles with data from several cross-institutional projects. The key is to ensure that from the beginning there is agreement on following the specific guidelines, standards and formats throughout the project. The issues to agree on are, among other things, storage and sharing of data and metadata, responsibilities for updating data, and deciding which data format to use. The benefits of FAIR data usage are summarized, and the article also describes the cross-institutional projects. The authors work as a senior consultant/project manager at the Danish National Archives, senior advisor at The Royal Danish Library, and communications officer at The Royal Danish Library. The cross-institutional projects mentioned here stretch from Kierkegaard’s writings to wind energy.
 While this issue started by mentioning that ICPSR was founded in 1962, we end with a more recent addition to the archive world, established at Qatar University’s Social and Economic Survey Research Institute (SESRI) in 2017. The paper ‘Data archiving for dissemination within a Gulf nation’ addresses the experience of this new institution in an environment of cultural and political sensitivity. With a positive view you can regard the benefits as expanding. The start is that archive staff get experience concerning policies for data selection, restrictions, security and metadata. This generates benefits and expands to the broader group of research staff where awareness and improvements relate to issues like design, collection and documentation of studies. Furthermore, data sharing can be seen as expanding in the Middle East and North Africa region and generating a general improvement in the relevance and credibility of statistics generated in the region. Again, the FAIR principles of findable, accessible, interoperable, and re-useable are gaining momentum and being adopted by government offices and data collection agencies. In the article, the story of SESRI at Qatar University is described ahead of sections concerning data sharing culture and challenges as well as issues of staff recruitment, architecture and workflow. Many of the observations and considerations in the article will be of value to staff at both older and infant archives. The authors of the paper are the senior researcher and lead archivist at the archive of the Qatar University Brian W. Mandikiana, and Lois Timms-Ferrara and Marc Maynard – CEO and director of technology at Data Independence (Connecticut, USA). 
 Submissions of papers for the IASSIST Quarterly are always very welcome. We welcome input from IASSIST conferences or other conferences and workshops, from local presentations or papers especially written for the IQ. When you are preparing such a presentation, give a thought to turning your one-time presentation into a lasting contribution. Doing that after the event also gives you the opportunity of improving your work after feedback. We encourage you to login or create an author login to https://www.iassistquarterly.com (our Open Journal System application). We permit authors 'deep links' into the IQ as well as deposition of the paper in your local repository. Chairing a conference session with the purpose of aggregating and integrating papers for a special issue IQ is also much appreciated as the information reaches many more people than the limited number of session participants and will be readily available on the IASSIST Quarterly website at https://www.iassistquarterly.com. Authors are very welcome to take a look at the instructions and layout:
 https://www.iassistquarterly.com/index.php/iassist/about/submissions
 Authors can also contact me directly via e-mail: kbr@sam.sdu.dk. Should you be interested in compiling a special issue for the IQ as guest editor(s) I will also be delighted to hear from you.
 Karsten Boye Rasmussen - September 2019

Abstract Aims Physical activity soon after surgery contributes to earlier discharge and better outcomes. However, patients often feel anxious to leave their ward and walk around. This project aimed to develop walking routes for patients in order to reduce this anxiety and encourage people to walk post-surgery. Once developed, we evaluated patients' views. Methods In a large hospital with five separate wings, we created a multi-professional team to advise on development. Safe walking routes were measured, timed, photographed and assessed for interest. We then produced a walking routes website, informed by multi-professional opinion, for use by patients from 21 surgical wards. This website was accessible to patients at the bedside, via a QR code scanned on their mobile phone. An electronic questionnaire on the website was used to assess patient satisfaction with the new resource. Results The majority of respondents (69.2%) felt that the walking routes website lead to them being more active during their admission (n=13). Respondents also felt that the website provided them with enjoyment, benefitted their mental health and made them feel more informed and involved in their recovery. Respondents felt their experience of the walking routes website would be improved by access to the website earlier in their hospital stay. Conclusion Despite the small sample size, this evaluation suggests the walking routes website has the potential to be a useful tool for surgical patients to increase early postoperative mobilisation, and improve patient hospital experiences.

Abstract Background Methamphetamine (meth) use is disproportionately high in rural settings and increased during COVID-19. While sterile syringes services are an evidence-based measure to reduce infectious disease transmission, little research exists around the value of smoking equipment, specifically pipes, in minimizing harms associated with rural drug use in the US. Methods Between March and June 2022, we conducted structured interviews with people who use methamphetamine (PWUM) living in rural Illinois who were at least 15 years old and used meth by any route in the past 30 days. Interview guides explored attitudes and behaviors regarding meth use routes, meth pipe use practice, and pipe access, and were refined by a peer-led Community Advisory Board. Interviews were audio recorded, transcribed, and coded in MAXQDA. The data were then analyzed for emergent themes using modified grounded theory. Results Nineteen participants, average age 37.1 (SD+8.7), were interviewed. Of these, 53% were women, and 89% were white. All reported smoking meth, and 84% injected meth. Participants reported that they often chose to smoke rather than inject to mitigate health concerns like wounds, pain, and infections. Smoking enabled them to use around others as opposed to using alone (as was typical when they injected). Participants expressed interest in pipe distribution through a harm reduction agency, e.g. according to one participant (a 31-year-old white male), “I’ve asked specifically if they had a pipe because I was trying to lay off the syringes.” They related that access to a harm reduction agency distributing pipes would connect people to other services such as HIV testing, naloxone, and safer sex supplies. Conclusion Distribution of meth pipes through harm reduction agencies represents a means for decreasing harm through circumvention of injection, decreased solitary drug use, and linkage to additional services related to overdose and disease prevention. Given increased rates of meth use in rural regions, this intervention could specifically address drug-related harms that impact rural PWUM. Future work should quantitatively explore the health impacts of pipe use as a harm reduction intervention. Disclosures All Authors: No reported disclosures

AbstractObjectiveThis systematic review evaluates and compares the efficacy and safety of different intranasal corticosteroid delivery methods for treating chronic rhinosinusitis with nasal polyps (CRSwNP).Data SourcesEmbase, Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, and Web of Science were systematically searched from January 1, 1980 to January 9, 2024.Review MethodsTwo independent reviewers searched 4 databases for English‐language, prospective randomized controlled trials (RCT), comparing different delivery methods of corticosteroids for the treatment of CRSwNP. Studies were excluded for specific reasons (wrong comparisons, wrong intervention, wrong patient population, and wrong route of administration).ResultsThe data search identified 2282 studies. After removing duplicates, 1503 studies were screened by title and abstract, with 1479 excluded for not meeting criteria. Eighteen full‐text articles were assessed for eligibility, and 5 RCTs were included in the review. Both short‐ and long‐term treatments with nebulizer, aerosol spray, and nasal drop methods demonstrated similar efficacy to oral corticosteroids (OCS) but with a better safety profile. Long‐term use of aqueous sprays showed clinical improvement but was less effective than other non‐aqueous delivery methods.ConclusionNon‐aqueous delivery methods, including nebulizers, aerosol sprays, and nasal drops offer a safe alternative to OCS without systemic side effects. Patients using aqueous formulations should be advised on the importance of long‐term adherence to achieve symptom improvement.

ImportanceIn 2023, the US Department of Health and Human Services (HHS) issued a letter to the administrator of the Drug Enforcement Administration (DEA) recommending rescheduling of cannabis (marijuana) from Schedule I to Schedule III under the Controlled Substances Act (CSA). This recommendation marked a significant departure from previous, consistent, and long-standing federal decisions on cannabis scheduling.ObjectiveTo critique the arguments made by HHS for recommending marijuana rescheduling.EvidenceThe HHS secretary (advisor) and US attorney general (decision maker) must consider 8 factors and a 5-part test when deciding whether to reschedule a controlled substance. CSA classification criteria include whether a drug has currently accepted medical use, whether it has abuse potential, and whether use is safe under medical supervision. HHS undermined these established legal scheduling criteria by introducing new, untested criteria.FindingsHHS failed to adequately address the adverse effects of cannabis use, including the high prevalence of cannabis use disorder among users, risks associated with youth consumption, growing evidence linking cannabis to psychosis, and other significant concerns. HHS asserted that cannabis is widely accepted as a legitimate form of medicine, despite the reality that only a small fraction of patient-care physicians recommend it for symptom relief, in practices that often diverge from the norms of medical practice. Finally, the US Food and Drug Administration has not approved cannabis as a medicine, as evidence is deficient in several key areas, including data from high-quality clinical trials, standardized cannabis formulations, established purity, defined routes of administration, dosing guidelines, and specific frequencies of use.Conclusions and RelevanceThe HHS rationale for reclassifying cannabis in myriad forms (edibles, smokables, drinkables, vaping products, suppositories) and potencies relies on a questionable selection of comparator drugs, downplays distinctive adverse events among cannabis users, and claims, unconvincingly, that cannabis has wide acceptance in medical practice supported by scientific evidence.

Ketamine, originally developed as a safer alternative to phencyclidine, has become a groundbreaking treatment in psychiatric practice. Approved by the United States Food and Drug Administration (FDA) in 1970 for its analgesic properties and ability to induce altered consciousness while preserving vital functions, ketamine gained renewed attention in the 1990s when researchers discovered its rapid and potent antidepressant effects, particularly in treatment-resistant depression. Ketamine’s mechanism of action involves blocking N-Methyl-D-Aspartate (NMDA) receptors, which leads to the release of inhibitory signals and increased glutamate levels. This cascade of events promotes neuronal growth and synaptic plasticity, both essential for its antidepressant effects. Various methods of administration have been explored, including intravenous (IV), intranasal, oral, subcutaneous, and intramuscular routes, each offering unique benefits and limitations. While IV ketamine remains the most widely used form, intranasal and sublingual formulations are increasingly popular for their improved accessibility and safety. Notably, the FDA and the European Medicines Agency (EMA) have approved intranasal S-ketamine for the treatment of resistant depression and depressive symptoms. Ketamine’s safety profile is generally favorable, with side effects that are mild, temporary, and self-limiting. However, caution is necessary for individuals with uncontrolled hypertension, cardiovascular issues, a history of psychosis, or substance abuse. Pregnant women are also advised against ketamine use, and potential interactions with other medications require careful consideration. Guidelines recommend ketamine as a third-line treatment option for resistant depression, to be considered after multiple unsuccessful antidepressant therapies. While international recommendations vary slightly, ketamine is increasingly recognized as a promising intervention for addressing the challenges of treatment-resistant depression. This review underscores the expanding role of ketamine in psychiatric care, particularly its applications in treatment- resistant depression and its potential to transform acute psychiatric emergency departments. It also sheds light on administration methods, safety considerations, and international guidelines for optimizing its use in challenging psychiatric conditions.

Salicylic Acid is an aromatic acid used in cosmetic formulations as a denaturant, hair-conditioning agent, and skin-conditioning agent—miscellaneous in a wide range of cosmetic products at concentrations ranging from 0.0008% to 3%. The Calcium, Magnesium, and MEA salts are preservatives, and Potassium Salicylate is a cosmetic biocide and preservative, not currently in use. Sodium Salicylate is used as a denaturant and preservative (0.09% to 2%). The TEA salt of Salicylic Acid is used as an ultraviolet (UV) light absorber (0.0001% to 0.75%). Several Salicylic Acid esters are used as skin conditioning agents—miscellaneous (Capryloyl, 0.1% to 1%; C12–15 Alkyl, no current use; Isocetyl, 3% to 5%; Isodecyl, no current use; and Tridecyl, no current use). Butyloctyl Salicylate (0.5% to 5%) and Hexyldodecyl Salicylate (no current use) are hair-conditioning agents and skin-conditioning agents—miscellaneous. Ethylhexyl Salicylate (formerly known as Octyl Salicylate) is used as a fragrance ingredient, sunscreen agent, and UV light absorber (0.001% to 8%), and Methyl Salicylate is used as a denaturant and flavoring agent (0.0001% to 0.6%). Myristyl Salicylate has no reported function. Isodecyl Salicylate is used in three formulations, but no concentration of use information was reported. Salicylates are absorbed percutaneously. Around 10% of applied salicylates can remain in the skin. Salicylic Acid is reported to enhance percutaneous penetration of some agents (e.g., vitamin A), but not others (e.g., hydrocortisone). Little acute toxicity (LD50 in rats; >2 g/kg) via a dermal exposure route is seen for Salicylic Acid, Methyl Salicylate, Tridecyl Salicylate, and Butyloctyl Salicylate. Short-term oral, inhalation, and parenteral exposures to salicylates sufficient to produce high blood concentrations are associated primarily with liver and kidney damage. Subchronic dermal exposures to undiluted Methyl Salicylate were associated with kidney damage. Chronic oral exposure to Methyl Salicylate produced bone lesions as a function of the level of exposure in 2-year rat studies; liver damage was seen in dogs exposed to 0.15 g/kg/day in one study; kidney and liver weight increases in another study at the same exposure; but no liver or kidney abnormalities in a study at 0.167 g/kg/day. Applications of Isodecyl, Tridecyl, and Butyloctyl Salicylate were not irritating to rabbit skin, whereas undiluted Ethylhexyl Salicylate produced minimal to mild irritation. Methyl Salicylate at a 1% concentration with a 70% ethanol vehicle were irritating, whereas a 6% concentration in polyethylene glycol produced little or no irritation. Isodecyl Salicylate, Methyl Salicylate, Ethylhexyl (Octyl) Salicylate, Tridecyl Salicylate, and Butyloctyl Salicylate were not ocular irritants. Although Salicylic Acid at a concentration of 20% in acetone was positive in the local lymph node assay, a concentration of 20% in acetone/olive oil was not. Methyl Salicylate was negative at concentrations up to 25% in this assay, independent of vehicle. Maximization tests of Methyl Salicylate, Ethylhexyl Salicylate, and Butyloctyl Salicylate produced no sensitization in guinea pigs. Neither Salicylic Acid nor Tridecyl Salicylate were photosensitizers. Salicylic Acid, produced when aspirin is rapidly hydrolyzed after absorption from the gut, was reported to be the causative agent in aspirin teratogenesis in animals. Dermal exposures to Methyl Salicylate, oral exposures to Salicylic Acid, Sodium Salicylate, and Methyl Salicylate, and parenteral exposures to Salicylic Acid, Sodium Salicylate, and Methyl Salicylate are all associated with reproductive and developmental toxicity as a function of blood levels reached as a result of exposure. An exposure assessment of a representative cosmetic product used on a daily basis estimated that the exposure from the cosmetic product would be only 20% of the level seen with ingestion of a “baby” aspirin (81 mg) on a daily basis. Studies of the genotoxic potential of Salicylic Acid, Sodium Salicylate, Isodecyl Salicylate, Methyl Salicylate, Ethylhexyl (Octyl) Salicylate, Tridecyl Salicylate, and Butyloctyl Salicylate were generally negative. Methyl Salicylate, in a mouse skin-painting study, did not induce neoplasms. Likewise, Methyl Salicylate was negative in a mouse pulmonary tumor system. In clinical tests, Salicylic Acid (2%) produced minimal cumulative irritation and slight or no irritation(1.5%); TEA-Salicylate (8%) produced no irritation; Methyl Salicylate (>12%) produced pain and erythema, a 1% aerosol produced erythema, but an 8% solution was not irritating; Ethylhexyl Salicylate (4%) and undiluted Tridecyl Salicylate produced no irritation. In atopic patients, Methyl Salicylate caused irritation as a function of concentration (no irritation at concentrations of 15% or less). In normal skin, Salicylic Acid, Methyl Salicylate, and Ethylhexyl (Octyl) Salicylate are not sensitizers. Salicylic Acid is not a photosensitizer, nor is it phototoxic. Salicylic Acid and Ethylhexyl Salicylate are low-level photoprotective agents. Salicylic Acid is well-documented to have keratolytic action on normal human skin. Because of the possible use of these ingredients as exfoliating agents, a concern exists that repeated use may effectively increase exposure of the dermis and epidermis to UV radiation. It was concluded that the prudent course of action would be to advise the cosmetics industry that there is a risk of increased UV radiation damage with the use of any exfoliant, including Salicylic Acid and the listed salicylates, and that steps need to be taken to formulate cosmetic products with these ingredients as exfoliating agents so as not to increase sun sensitivity, or when increased sun sensitivity would be expected, to include directions for the daily use of sun protection. The available data were not sufficient to establish a limit on concentration of these ingredients, or to identify the minimum pH of formulations containing these ingredients, such that no skin irritation would occur, but it was recognized that it is possible to formulate cosmetic products in a way such that significant irritation would not be likely, and it was concluded that the cosmetics industry should formulate products containing these ingredients so as to be nonirritating. Although simultaneous use of several products containing Salicylic Acid could produce exposures greater than would be seen with use of baby aspirin (an exposure generally considered to not present a reproductive or developmental toxicity risk), it was not considered likely that consumers would simultaneously use multiple cosmetic products containing Salicylic Acid. Based on the available information, the Cosmetic Ingredient Review Expert Panel reached the conclusion that these ingredients are safe as used when formulated to avoid skin irritation and when formulated to avoid increasing the skin's sun sensitivity, or, when increased sun sensitivity would be expected, directions for use include the daily use of sun protection.


 
 
 If the home is traditionally considered to be a space of safety associated with the warm and cosy feeling of the familial hearth, it is also continuously portrayed as a space under threat from the outside from which we must secure ourselves and our families. Securing the home entails a series of material, discursive and performative strategies, a host of precautionary measures aimed at regulating and ultimately producing security. When I was eleven my family returned home from the local fruit markets to find our house had been ransacked. Clothes were strewn across the floor, electrical appliances were missing and my parents’ collection of jewellery – wedding rings and heirlooms – had been stolen. Few things remained untouched and the very thought of someone else’s hands going through our personal belongings made our home feel tainted. My parents were understandably distraught. As Filipino immigrants to Australia the heirlooms were not only expensive assets from both sides of my family, but also signifiers of our homeland. Added to their despair was the fact that this was our first house – we had rented prior to that. During the police interviews, we discovered that our area, Sydney’s Western suburbs, was considered ‘high-risk’ and we were advised to install security. In their panic my parents began securing their home. Grills were installed on every window. Each external wooden door was reinforced by a metal security door. Movement detectors were installed at the front of the house, which were set to blind intruders with floodlights. Even if an intruder could enter the back through a window a metal grill security door was waiting between the backroom and the kitchen to stop them from getting to our bedrooms. In short, through a series of transformations our house was made into a residential fortress. Yet home security had its own dangers. A series of rules and regulations were drilled into me ‘in case of an emergency’: know where your keys are in case of a fire so that you can get out; remember the phone numbers for an emergency and the work numbers of your parents; never let a stranger into the house; and if you need to speak to a stranger only open the inside door but leave the security screen locked. Thus, for my Filipino-migrant family in the 1990s, a whole series of defensive behaviours and preventative strategies were produced and disseminated inside and around the home to regulate security risks. Such “local knowledges” were used to reinforce the architectural manifestations of security at the same time that they were a response to the invasion of security systems into our house that created a new set of potential dangers. This article highlights “the interplay of material and symbolic geographies of home” (Blunt and Varley 4), focusing on the relation between urban fears circulating around and within the home and the spatial practices used to negotiate such fears. In exploring home security systems it extends the exemplary analysis of home technologies already begun in Lynn Spigel’s reading of the ‘smart home’ (381-408). In a similar vein, David Morley’s analysis of mediated domesticity shows how communications technology has reconfigured the inside and outside to the extent that television actually challenges the physical boundary that “protects the privacy and solidarity of the home from the flux and threat of the outside world” (87). Television here serves as a passage in which the threat of the outside is reframed as news or entertainment for family viewing. I take this as a point of departure to consider the ways that this mediated fear unfolds in the technology of our homes. Following Brian Massumi, I read the home as “a node in a circulatory network of many dimensions (each corresponding to a technology of transmission)” (85). For Massumi, the home is an event-space at the crossroads of media technologies and political technologies. “In spite of the locks on the door, the event-space of the home must be seen as one characterized by a very loose regime of passage” (85). The ‘locked door’ is not only a boundary marker that defines the inside from the outside but another technology that leads us outside the home into other domains of inquiry: the proliferation of security technologies and the mundane, fearful intimacies of the home. In this context, we should heed Iris Marion Young’s injunction to feminist critics that the home does provide some positives including a sense of privacy and the space to build relationships and identities. Yet, as Colomina argues, the traditional domestic ideal “can only be produced by engaging the home in combat” (20). If, as Colomina’s comment suggests, ontological security is at least partially dependent on physical security, then this article explores the ontological effects of our home security systems. Houses at War: Targeting the Family As Beatriz Colomina reminds us, in times of war we leave our homelands to do battle on the front line, but battle lines are also being drawn in our homes. Drawing inspiration from Virilio’s claim that contemporary war takes place without fighting, Colomina’s article ‘Domesticity at War’ contemplates the domestic interior as a “battlefield” (15). The house, she writes, is “a mechanism within a war where the differences between defense [sic] and attack have become blurred” (17). According to the Home Security Precautions, New South Wales, October 1999 report conducted by the Australian Bureau of Statistics, 47% of NSW dwellings were ‘secure’ (meaning that they either had a burglar alarm, or all entry points were secured or they were inside a security block) while only 9% of NSW households had no home security devices present (Smith 3). In a similar report for Western Australia conducted in October 2004, an estimated 71% of WA households had window security of some sort (screens, locks or shutters) while 67% had deadlocks on at least one external door (4). An estimated 27% had a security alarm installed while almost half (49%) had sensor lights (Hubbard 4-5). This growing sense of insecurity means big business for those selling security products and services. By the end of June 1999, there were 1,714 businesses in Australia’s security services industry generating $1,395 million of income during 1998-99 financial year (McLennan 3; see also Macken). This survey did not include locksmith services or the companies dealing with alarm manufacturing, wholesaling or installing. While Colomina’s article focuses on the “war with weather” and the attempts to control environmental conditions inside the home through what she calls “counterdomesticity” (20), her conceptualisation of the house as a “military weapon” (17) provides a useful tool for thinking the relation between the home, architecture and security. Conceiving of the house as a military weapon might seem like a stretch, but we should recall that the rhetoric of war has already leaked into the everyday. One hears of the ‘war on drugs’ and the ‘war on crime’ in the media. ‘War’ is the everyday condition of our urban jungles (see also Diken and Lausten) and in order to survive, let alone feel secure, one must be able to defend one’s family and home. Take, for example, Signal Security’s website. One finds a panel on the left-hand side of the screen to all webpages devoted to “Residential Products”. Two circular images are used in the panel with one photograph overlapping the other. In the top circle, a white nuclear family (stereotypical mum, dad and two kids), dressed in pristine white clothing bare their white teeth to the internet surfer. Underneath this photo is another photograph in which an arm clad in a black leather jacket emerges through a smashed window. In the foreground a black-gloved hand manipulates a lock, while a black balaclava masks an unrecognisable face through the broken glass. The effect of their proximity produces a violent juxtaposition in which the burglar visually intrudes on the family’s domestic bliss. The panel stages a struggle between white and black, good and bad, family and individual, security and insecurity, recognisability and unidentifiability. It thus codifies the loving, knowable family as the domestic space of security against the selfish, unidentifiable intruder (presumed not to have a family) as the primary reason for insecurity in the family home – and no doubt to inspire the consumption of security products. Advertisements of security products thus articulate the family home as a fragile innocence constantly vulnerable from the outside. From a feminist perspective, this image of the family goes against the findings of the National Homicide Monitoring Program, which shows that 57% of the women killed in Australia between 2004 and 2005 were killed by an intimate partner while 17% were killed by a family member (Mouzos and Houliaras 20). If, on the one hand, the family home is targeted by criminals, on the other, it has emerged as a primary site for security advertising eager to exploit the growing sense of insecurity – the family as a target market. The military concepts of ‘target’ and ‘targeting’ have shifted into the benign discourse of strategic advertising. As Dora Epstein writes, “We arm our buildings to arm ourselves from the intrusion of a public fluidity, and thus our buildings, our architectures of fortification, send a very clear message: ‘avoid this place or protect yourself’” (1997: 139). Epstein’s reference to ‘architectures of fortification’ reminds us that the desire to create security through the built environment has a long history. Nan Ellin has argued that fear’s physical manifestation can be found in the formation of towns from antiquity to the Renaissance. In this sense, towns and cities are always already a response to the fear of foreign invaders (Ellin 13; see also Diken and Lausten 291). This fear of the outsider is most obviously manifested in the creation of physical walls. Yet fortification is also an effect of spatial allusions produced by the configuration of space, as exemplified in Fiske, Hodge and Turner’s semiotic reading of a suburban Australian display home without a fence. While the lack of a fence might suggest openness, they suggest that the manicured lawn is flat so “that eyes can pass easily over it – and smooth – so that feet will not presume to” (30). Since the front garden is best viewed from the street it is clearly a message for the outside, but it also signifies “private property” (30). Space is both organised and lived, in such a way that it becomes a medium of communication to passers-by and would-be intruders. What emerges in this semiotic reading is a way of thinking about space as defensible, as organised in a way that space can begin to defend itself. The Problematic of Defensible Space The incorporation of military architecture into civil architecture is most evident in home security. By security I mean the material systems (from locks to electronic alarms) and precautionary practices (locking the door) used to protect spaces, both of which are enabled by a way of imagining space in terms of risk and vulnerability. I read Oscar Newman’s 1972 Defensible Space as outlining the problematic of spatial security. Indeed, it was around that period that the problematic of crime prevention through urban design received increasing attention in Western architectural discourse (see Jeffery). Newman’s book examines how spaces can be used to reinforce human control over residential environments, producing what he calls ‘defensible space.’ In Newman’s definition, defensible space is a model for residential environments which inhibits crime by creating the physical expression of a social fabric that defends itself. All the different elements which combine to make a defensible space have a common goal – an environment in which latent territoriality and sense of community in the inhabitants can be translated into responsibility for ensuring a safe, productive, and well-maintained living space (3). Through clever design space begins to defend itself. I read Newman’s book as presenting the contemporary problematic of spatialised security: how to structure space so as to increase control; how to organise architecture so as to foster territorialism; how to encourage territorial control through amplifying surveillance. The production of defensible space entails moving away from what he calls the ‘compositional approach’ to architecture, which sees buildings as separate from their environments, and the ‘organic approach’ to architecture, in which the building and its grounds are organically interrelated (Newman 60). In this approach Newman proposes a number of changes to space: firstly, spaces need to be multiplied (one no longer has a simple public/private binary, but also semi-private and semi-public spaces); secondly, these spaces must be hierarchised (moving from public to semi-public to semi-private to private); thirdly, within this hierarchy spaces can also be striated using symbolic or material boundaries between the different types of spaces. Furthermore, spaces must be designed to increase surveillance: use smaller corridors serving smaller sets of families (69-71); incorporate amenities in “defined zones of influence” (70); use L-shaped buildings as opposed to rectangles (84); use windows on the sides of buildings to reveal the fire escape from outside (90). As he puts it, the subdivision of housing projects into “small, recognisable and comprehensible-at-a-glance enclaves is a further contributor to improving the visual surveillance mechanism” (1000). Finally, Newman lays out the principle of spatial juxtaposition: consider the building/street interface (positioning of doors and windows to maximise surveillance); consider building/building interface (e.g. build residential apartments next to ‘safer’ commercial, industrial, institutional and entertainment facilities) (109-12). In short, Newman’s book effectively redefines residential space in terms of territorial zones of control. Such zones of influence are the products of the interaction between architectural forms and environment, which are not reducible to the intent of the architect (68). Thus, in attempting to respond to the exigencies of the moment – the problem of urban crime, the cost of housing – Newman maps out residential space in what Foucault might have called a ‘micro-physics of power’. During the mid-1970s through to the 1980s a number of publications aimed at the average householder are printed in the UK and Australia. Apart from trade publishing (Bunting), The UK Design Council released two small publications (Barty, White and Burall; Design Council) while in Australia the Department of Housing and Construction released a home safety publication, which contained a small section on security, and the Australian Institute of Criminology published a small volume entitled Designing out Crime: Crime prevention through environmental design (Geason and Wilson). While Newman emphasised the responsibility of architects and urban planners, in these publications the general concerns of defensible space are relocated in the ‘average homeowner’. Citing crime statistics on burglary and vandalism, these publications incite their readers to take action, turning the homeowner into a citizen-soldier. The householder, whether he likes it or not, is already in a struggle. The urban jungle must be understood in terms of “the principles of warfare” (Bunting 7), in which everyday homes become bodies needing protection through suitable architectural armour. Through a series of maps and drawings and statistics, the average residential home is transformed into a series of points of vulnerability. Home space is re-inscribed as a series of points of entry/access and lines of sight. Simultaneously, through lists of ‘dos and don’ts’ a set of precautionary behaviours is inculcated into the readers. Principles of security begin codifying the home space, disciplining the spatial practices of the intimate, regulating the access and mobility of the family and guests. The Architectural Nervous System Nowadays we see a wild, almost excessive, proliferation of security products available to the ‘security conscious homeowner’. We are no longer simply dealing with security devices designed to block – such as locks, bolts and fasteners. The electronic revolution has aided the production of security devices that are increasingly more specialised and more difficult to manipulate, which paradoxically makes it more difficult for the security consumer to understand. Detection systems now include continuous wiring, knock-out bars, vibration detectors, breaking glass detectors, pressure mats, underground pressure detectors and fibre optic signalling. Audible alarm systems have been upgraded to wire-free intruder alarms, visual alarms, telephone warning devices, access control and closed circuit television and are supported by uninterruptible power supplies and control panels (see Chartered Institution of Building Service Engineers 19-39). The whole house is literally re-routed as a series of relays in an electronic grid. If the house as a security risk is defined in terms of points of vulnerability, alarm systems take these points as potential points of contact. Relays running through floors, doors and windows can be triggered by pressure, sound or dislocation. We see a proliferation of sensors: switching sensors, infra-red sensors, ultrasonic sensors, microwave radar sensors, microwave fence sensors and microphonic sensors (see Walker). The increasing diversification of security products attests to the sheer scale of these architectural/engineering changes to our everyday architecture. In our fear of crime we have produced increasingly more complex security products for the home, thus complexifying the spaces we somehow inherently feel should be ‘simple’. I suggest that whereas previous devices merely reinforced certain architectural or engineering aspects of the home, contemporary security products actually constitute the home as a feeling, architectural body capable of being affected. This recalls notions of a sensuous architecture and bodily metaphors within architectural discourse (see Thomsen; Puglini). It is not simply our fears that lead us to secure our homes through technology, but through our fears we come to invest our housing architecture with a nervous system capable of fearing for itself. Our eyes and ears become detection systems while our screams are echoed in building alarms. Body organs are deterritorialised from the human body and reterritorialised on contemporary residential architecture, while our senses are extended through modern security technologies. The vulnerable body of the family home has become a feeling body conscious of its own vulnerability. It is less about the physical expression of fear, as Nan Ellin has put it, than about how building materialities become capable of fearing for themselves. What we have now are residential houses that are capable of being more fully mobilised in this urban war. Family homes become bodies that scan the darkness for the slightest movements, bodies that scream at the slightest possibility of danger. They are bodies that whisper to each other: a house can recognise an intrusion and relay a warning to a security station, informing security personnel without the occupants of that house knowing. They are the newly produced victims of an urban war. Our homes are the event-spaces in which mediated fear unfolds into an architectural nervous system. If media plug our homes into one set of relations between ideologies, representations and fear, then the architectural nervous system plugs that back into a different set of relations between capital, fear and the electronic grid. The home is less an endpoint of broadcast media than a node in an electronic network, a larger nervous system that encompasses the globe. It is a network that plugs architectural nervous systems into city electronic grids into mediated subjectivities into military technologies and back again, allowing fear to be disseminated and extended, replayed and spliced into the most banal aspects of our domestic lives. 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Durham and London: Duke University Press, 2001. Thomsen, Christian W. Sensuous Architecture: The Art of Erotic Building. Munich and New York: Prestel, 1998. Walker, Philip. Electronic Security Systems: Better Ways to Crime Prevention. London: Butterworths, 1983. Young, Iris Marion. “House and Home: Feminist Variations on a Theme.” Feminist Interpretations of Martin Heidegger. Eds. Nancy J. Holland and Patricia Huntington. University Park, Pennsylvania: Pennsylvania State UP, 2001. 
 
 
 
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