Browsing by Subject "Safety"

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  • Uudekll, Peep; Kozlova, Jekaterina; Mandar, Hugo; Link, Joosep; Sihtmae, Mariliis; Kaosaar, Sandra; Blinova, Irina; Kasemets, Kaja; Kahru, Anne; Stern, Raivo; Tatte, Tanel; Kukli, Kaupo; Tamm, Aile (2017)
    Spherical nickel particles with size in the range of 100-400 nm were synthesized by non-aqueous liquid phase benzyl alcohol method. Being developed for magnetically guided biomedical applications, the particles were coated by conformal and antimicrobial thin titanium oxide films by atomic layer deposition. The particles retained their size and crystal structure after the deposition of oxide films. The sensitivity of the coated particles to external magnetic fields was increased compared to that of the uncoated powder. Preliminary toxicological investigations on microbial cells and small aquatic crustaceans revealed non-toxic nature of the synthesized particles.
  • Kortteenniemi, Aaron; Lehto, Soili M.; Javadi, Amir-Homayoun (2019)
  • Qian, C.; Huhtakangas, J.; Juvela, S.; Bode, M. K.; Tatlisumak, T.; Savolainen, M.; Numminen, H.; Ollikainen, J.; Luostarinen, L.; Kupila, L.; Tetri, S. (2021)
    Backround: Venous thromboembolism (VTE) after primary intracerebral hemorrhage (ICH) worsens patient prognosis. Administering low-molecular weight heparins (LMWH) to prevent VTE early (24 h) may increase the risk of hematoma enlargement, whereas administering late (72 h) after onset may decrease its effect on VTE prevention. The authors investigated when it is safe and effective to start LMWH in ICH patients. Methods: In the setting of double blinded, placebo controlled randomization, patients >18 years of age with paretic lower extremity, and admitted to the emergency room within 12 h of the onset of ICH, were randomized into two groups. Patients in the enoxaparin group received 20 mg twice a day 24 h (early) after the onset of ICH and in the placebo group 72 h (late) after onset respectively. Both groups immediately received intermittent pneumatic compression stockings at the ER. Patients were prospectively and routinely screened for VTE and hemorrhagic complications 1 day after entering the study and again before discharge. Results: 139 patients were included for randomization in this study. Only 3 patients developed VTE, 2 in the early enoxaparin group and one in the late enoxaparin group. No patients developed PE. Thromboembolic events (p = 0.901), risk of hematoma enlargement (p = 0.927) and overall outcome (P = 0.904) did not differ significantly between the groups. Conclusion: Administering 40 mg/d LMWH for prevention of VTE to a spontaneous ICH patient is safe regardless of whether it is started 24 h (early) or 72 h (late) after the hemorrhage. Risk of hemorrhage enlargement is not associated with early LMWH treatment. Administering LMWH late did not increase VTEs.
  • Hirvelä, Jaakko (2017)
    According to the safety condition, a subject knows that p only if she would believe that p only if p was true. The safety condition has been a very popular necessary condition for knowledge of late. However, it is well documented that the safety condition is trivially satisfied in cases where the subject believes in a necessary truth. This is for the simple reason that a necessary truth is true in all possible worlds, and therefore it is true in all possible worlds where it is believed. But clearly, all beliefs concerning necessary truths do not amount to knowledge. The safety theorists have attempted to deal with the problem caused by necessary truths by restricting the safety condition to purely contingent truths and by globalizing the safety condition to a set of propositions. Both of these solutions are problematic. The principal aim of this paper is to develop a version of the safety condition that is able to deal with cases featuring necessary truths.
  • Vink, P.; Torrell, J.M.R.; Fructuoso, A.S.; Kim, Sung-Joo; Kim, Sang-Il; Zaltzman, J.; Ortiz, F.; Plana, J.M.C.; Rodriguez, A.M.F.; Rodrigo, H.R.; Marti, M.C.; Perez, R.; Roncero, F.M.G.; Kumar, D.; Chiang, Y.-J.; Doucette, K.; Pipeleers, L.; Morales, M.L.A.; Rodriguez-Ferrero, M.L.; Secchi, Antonio; McNeil, S.A.; Campora, L.; Di Paolo, E.; El Idrissi, M.; López-Fauqued, M.; Salaun, B.; Heineman, T.C.; Oostvogels, L. (2020)
    Background. The incidence of herpes zoster is up to 9 times higher in immunosuppressed solid organ transplant recipients than in the general population. We investigated the immunogenicity and safety of an adjuvanted recombinant zoster vaccine (RZV) in renal transplant (RT) recipients ≥18 years of age receiving daily immunosuppressive therapy. Methods. In this phase 3, randomized (1:1), observer-blind, multicenter trial, RT recipients were enrolled and received 2 doses of RZV or placebo 1-2 months (M) apart 4-18M posttransplant. Anti-glycoprotein E (gE) antibody concentrations, gE-specific CD4 T-cell frequencies, and vaccine response rates were assessed at 1M post-dose 1, and 1M and 12M post-dose 2. Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days after each dose, respectively. Solicited general symptoms and unsolicited AEs were also collected 7 days before first vaccination. Serious AEs (including biopsy-proven allograft rejections) and potential immune-mediated diseases (pIMDs) were recorded up to 12M post-dose 2. Results. Two hundred sixty-four participants (RZV: 132; placebo: 132) were enrolled between March 2014 and April 2017. gE-specific humoral and cell-mediated immune responses were higher in RZV than placebo recipients across postvaccination time points and persisted above prevaccination baseline 12M post-dose 2. Local AEs were reported more frequently by RZV than placebo recipients. Overall occurrences of renal function changes, rejections, unsolicited AEs, serious AEs, and pIMDs were similar between groups. Conclusions. RZV was immunogenic in chronically immunosuppressed RT recipients. Immunogenicity persisted through 12M postvaccination. No safety concerns arose. © The Author(s) 2019.
  • Falconer, Christian; Altman, Daniel; Poutakidis, Georgios; Rahkola-Soisalo, Päivi; Mikkola, Tomi; Morcos, Edward (2021)
    Purpose The aim of this study was to compare long-term effects of high-volume surgery at a single-center to multicenter use when using a mesh-capturing device for pelvic organ prolapse (POP) repair. Methods Five years after surgery 101 (88%) at the single center were compared with 164 (81.2%) in the multicenter trial. Outcome measurements included clinical examination, prolapse-specific symptom questionnaires [Pelvic Floor Distress Inventory 20 (PFDI-20), Pelvic Floor Impact Questionnaire-short form (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)] and pain estimation by VAS (0-10). Results Optimal apical segment outcome was 95% in the single- compared to 83.3% in the multicenter study (p <0.001). POP recurrence in the anterior and posterior walls (POP-Q, Ba and Bp >= 0) was more common at the multicenter as compared to the single center [(19.8% vs 5.4%) and (26% vs 2.7%), (p <0.001)]. Reoperations for POP and mesh-related complications were more frequent in the multicenter study [31/202 (15.3%) vs 7/116 (6.1%),p <0.001]. Total PFDI-20, PFIQ-7 and PISQ-12 scores were comparable between the cohorts. There were no significant differences in overall pain scores in-between the cohorts during follow-up. At the single center, 1/81 patients (1.2%) had VAS 7/10, i.e. severe pain, as compared to 3/131 (2.3%) in the multicenter study (p = 0.277). Conclusions Despite the high objective and subjective long-term effectiveness of the procedure in both regular use, and at a high-volume center, centralizing the use of a standardized capturing-device guided transvaginal mesh for POP repair reduced secondary interventions by more than half.
  • Dominguez-Hernandez, Elisa; Salaseviciene, Alvija; Ertbjerg, Per (2018)
    Abstract Heat treatment of meat at temperatures between 50 and 65 °C, for extended periods of time, is known as low-temperature long-time (LTLT) cooking. This cooking method produces meat that has increased tenderness and better appearance than when cooked at higher temperatures. Public concerns regarding this method have focused on the ability to design heat treatments that can reach microbiological safety. The heat treatment induces modification of the meat structure and its constituents, which can explain the desirable eating quality traits obtained. Denaturation, aggregation, and degradation of myofibrillar, sarcoplasmic and connective tissue proteins occur depending on the combination of time and temperature during the heat treatment. The protein changes, especially in relation to collagen denaturation, along with proteolytic activity, have often been regarded to be the main contributors to the increased meat tenderness. The mechanisms involved and the possible contribution of other factors are reviewed and discussed.
  • Tervo, Markku; Koisaarai, Tapio; Tervo, Timo (2016)
  • Hirvelä, Jaakko (2020)
    In order to deal with the problem caused by environmental luck some proponents of robust virtue epistemology have attempted to argue that in virtue of satisfying the ability condition one will satisfy the safety condition. Call this idea the entailment thesis. In this paper it will be argued that the arguments that have been laid down for the entailment thesis entail a wrong kind of safety condition, one that we do not have in mind when we require our beliefs to be safe from error in order for them to be knowledge.
  • Perdomo, Maria F.; Toppinen, Mari; Hedman, Klaus; Sajantila, Antti (2018)
  • Gylling, Helena; Plat, Jogchum; Turley, Stephen; Ginsberg, Henry N.; Ellegard, Lars; Jessup, Wendy; Jones, Peter J.; Luetjohann, Dieter; Maerz, Winfried; Masana, Luis; Silbernagel, Guenther; Staels, Bart; Boren, Jan; Catapano, Alberico L.; De Backer, Guy; Deanfield, John; Descamps, Olivier S.; Kovanen, Petri T.; Riccardi, Gabriele; Tokgozoglu, Lale; Chapman, M. John; European Atherosclerosis Soc (2014)
  • Geva, Ravit; Lopez, Juanita; Danson, Sarah; Joensuu, Heikki; Peer, Avivit; Harris, Samuel J.; Souza, Fabricio; Pereira, Kaline M. C.; Perets, Ruth (2019)
    Purpose Concomitant treatment with radium-223 and paclitaxel is a potential option for cancer patients with bone metastases; however, myelosuppression risk during coadministration is unknown. This phase Ib study in cancer patients with bone metastases evaluated the safety of radium-223 and paclitaxel. Methods Eligible patients had solid tumor malignancies with >= 2 bone metastases and were candidates for paclitaxel. Treatment included seven paclitaxel cycles (90 mg/m(2) per week intravenously per local standard of care; 3 weeks on/1 week off) plus six radium-223 cycles (55 kBq/kg intravenously; one injection every 4 weeks, starting at paclitaxel cycle 2). The primary end point was percentage of patients with grade 3/4 neutropenia or thrombocytopenia during coadministration of radium-223 and paclitaxel (cycles 2, 3) versus paclitaxel alone (cycle 1). Results Of 22 enrolled patients, 15 were treated (safety population), with 7 completing all six radium-223 cycles. Treated patients had primary cancers of breast (n = 7), prostate (n = 4), bladder (n = 1), non-small cell lung (n = 1), myxofibrosarcoma (n = 1), and neuroendocrine (n = 1). No patients discontinued treatment from toxicity of the combination. In the 13 patients who completed cycle 3, the rates of grade 3 neutropenia in cycles 2 and 3 were 31% and 8%, respectively, versus 23% in cycle 1; there were no cases of grade 4 neutropenia or grade 3/4 thrombocytopenia. Breast cancer subgroup safety results were similar to the overall safety population. Conclusion Radium-223 was tolerated when combined with weekly paclitaxel, with no clinically relevant additive toxicities. This combination should be explored further in patients with bone metastases.
  • Rauma, Ilkka; Mustonen, Tiina; Seppä, Juha Matti; Ukkonen, Maritta; Mannikko, Marianne; Verkkoniemi-Ahola, Auli; Kartau, Marge; Saarinen, Jukka T.; Luostarinen, Liisa; Simula, Sakari; Ryytty, Mervi; Ahmasalo, Riitta; Sipilä, Jussi O. T.; Pieninkeroinen, Ilkka; Tapiola, Tero; Remes, Anne M.; Kuusisto, Hanna (2022)
    Background Alemtuzumab is an effective disease-modifying therapy (DMT) for highly active multiple sclerosis (MS). However, safety concerns limit its use in clinical practice. Objectives To evaluate the safety of alemtuzumab in a nationwide cohort of Finnish MS patients. Methods In this retrospective case series study, we analyzed the data of all but two MS patients who had received alemtuzumab in Finland until 2019. Data were systematically collected from patient files. Results Altogether 121 patients were identified, most of whom had received previous DMTs (82.6%). Median follow-up time after treatment initiation was 30.3 months and exceeded 24 months in 78 patients. Infusion-associated reactions (IARs) were observed in 84.3%, 57.3%, and 57.1% of patients during alemtuzumab courses 1-3, respectively. Serious adverse events (SAEs) were observed in 32.2% of patients, serious IARs in 12.4% of patients, and SAEs other than IARs in 23.1% of patients. Autoimmune adverse events were observed in 30.6% of patients. One patient died of hemophagocytic lymphohistiocytosis, and one patient died of pneumonia. A previously unreported case of thrombotic thrombocytopenic purpura was documented. Conclusions SAEs were more frequent in the present cohort than in previous studies. Even though alemtuzumab is a highly effective therapy for MS, vigorous monitoring with a long enough follow-up time is advised.
  • Laaveri, Tinja; Sterne, Jesper; Rombo, Lars; Kantele, Anu (2016)
    Looking at the worldwide emergency of antimicrobial resistance, international travellers appear to have a central role in spreading the bacteria across the globe. Travellers' diarrhoea (TD) is the most common disease encountered by visitors to the (sub) tropics. Both TD and its treatment with antibiotics have proved significant independent risk factors of colonization by resistant intestinal bacteria while travelling. Travellers should therefore be given preventive advice regarding TD and cautioned about taking antibiotics: mild or moderate TD does not require antibiotics. Logical alternatives are medications with effects on gastrointestinal function, such as loperamide. The present review explores literature on loperamide in treating TD. Adhering to manufacturer's dosage recommendations, loperamide offers a safe and effective alternative for relieving mild and moderate symptoms. Moreover, loperamide taken singly does no predispose to contracting MDR bacteria. Most importantly, we found no proof that would show antibiotics to be significantly more effective than loperamide in treating mild/moderate TD. (C) 2016 The Authors. Published by Elsevier Ltd.