15 resultados para unacceptable
em BORIS: Bern Open Repository and Information System - Berna - Suiça
Resumo:
Tomatoes are the most common crop in Italy. The production cycle requires operations in the field and factory that can cause musculoskeletal disorders due to the repetitive movements of the upper limbs of the workers employed in the sorting phase. This research aims to evaluate these risks using the OCRA (occupational repetitive actions) index method This method is based firstly on the calculation of a maximum number of recommended actions, related to the way the operation is performed, and secondly on a comparison of the number of actions effectively carried out by the upper limb with the recommended calculated value. The results of the risk evaluation for workers who manually sort tomatoes during harvest showed a risk for the workers, with an exposure index greater than 20; the OCRA index defines an index higher than 3.5 as unacceptable. The present trend of replacing manual sorting onboard a vehicle with optical sorters seems to be appropriate to reduce the risk of work-related musculoskeletal disorders (WMSDs) and is supported from both a financial point of view and as a quality control measure.
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Many efforts have been made in Ethiopia to mitigate land degradation, particularly soil erosion, through both local and newly introduced soil and water conservation (SWC) practices. However, the strict focus on soil erosion and conservation does not necessarily lead to satisfactory results. If SWC is effective in reducing erosion but is at the same time too costly and unacceptable to land users, sooner or later it will disappear and its positive effects will also be lost. This book therefore suggests to follow the broader approach of Sustainable Land Management (SLM), which aims at ecological soundness, economic viability and social acceptability, and thus places SWC in a more holistic framework that is closer to farmers’ reality.
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BACKGROUND: The addition of ketamine to morphine for patient-controlled analgesia (PCA) is supported by previous basic and clinical research, but has been challenged by subsequent negative studies. Important limitations of previous studies are the low number of patients analyzed, the use of morphine-ketamine combinations that may not the optimal, and that not all the relevant outcomes have been analyzed. In this study, we compared the combination of morphine and ketamine with morphine alone for postoperative PCA in large patient groups. We used a morphine-ketamine combination identified by an optimization procedure in our previous study. METHODS: After major elective orthopedic surgery, 352 patients received either PCA with morphine bolus 1.5 mg (Group M, n = 176) or a bolus of morphine plus ketamine 1.5 mg each (Group MK, n = 176) in a randomized, double-blind fashion. Unsatisfactory treatment was defined as the occurrence of either inadequate analgesia or unacceptable side effects. In addition, total consumption of PCA drugs, duration of PCA use, direct medical costs, and number of patients with chronic postoperative pain 3 and 6 mo after operation were recorded. RESULTS: The incidence of unsatisfactory treatment was 33.0% in Group M and 36.9% in Group MK (P = 0.50). No significant differences were found between the groups with respect to secondary end points. CONCLUSIONS: Small-dose ketamine combined with morphine for PCA provides no benefit to patients undergoing major orthopedic surgery and cannot be recommended for routine use.
Resumo:
This case series reports on the use of nonsilica-based high-strength full ceramics for different prosthetic indications. Fifty-two consecutive patients received tooth- or implant-supported zirconia reconstructions during a 2-year period. The observation period for reexamination was 12 to 30 months. The most frequent indications were single crowns and short-span fixed partial dentures. A few implant superstructures were screw-retained, whereas all remaining restorations were cemented on natural teeth or zirconia implant abutments. Clinical examination included biologic (probing depths, bleeding on probing) and esthetic (Papilla Index) parameters, as well as technical complications. No implant was lost or caused any problems, but two teeth were lost after horizontal fracture. Overall, the periodontal parameters were favorable. Fractures of frameworks or implant abutments were not observed. Abutment-screw loosening occurred once for one premolar single crown. Furthermore, five implant crowns in the posterior region exhibited chipping of the porcelain veneering material. With regard to esthetics, no reconstructions were considered unacceptable, but three crowns were remade shortly after delivery. In this short-term study, it was observed that biologic, esthetic, and mechanical properties of zirconia were favorable, and the material could be used in various prosthetic indications on teeth or implants.
Resumo:
PURPOSE: We assessed the safety of the multikinase inhibitor regorafenib in patients with hepatocellular carcinoma (HCC) that had progressed following first-line sorafenib. PATIENTS AND METHODS: Thirty-six patients with Barcelona Clinic Liver Cancer stage B or C HCC and preserved to mildly impaired liver function (Child-Pugh class A) received regorafenib 160 mg once daily in cycles of 3 weeks on/1 week off treatment until disease progression, unacceptable toxicity, death or patient/physician decision to discontinue. The primary end-point was safety; secondary end-points included efficacy (including time to progression and overall survival). RESULTS: The median treatment duration was 19.5 weeks (range 2-103). At data cutoff, three patients remained on treatment. Reasons for discontinuation were adverse events (n=20), disease progression (n=10), consent withdrawal (n=2) and death (n=1). Seventeen patients required dose reductions (mostly for adverse events [n=15]); 35 patients had treatment interruption (mostly for adverse events [n=32] or patient error [n=11]). The most frequent treatment-related adverse events were hand-foot skin reaction (any grade n=19; grade ≥3 n=5), diarrhoea (n=19; n=2), fatigue (n=19; n=6), hypothyroidism (n=15; n=0), anorexia (n=13; n=0), hypertension (n=13; n=1), nausea (n=12; n=0) and voice changes (n=10; n=0). Disease control was achieved in 26 patients (partial response n=1; stable disease n=25). Median time to progression was 4.3 months. Median overall survival was 13.8 months. CONCLUSION: Regorafenib had acceptable tolerability and evidence of antitumour activity in patients with intermediate or advanced HCC that progressed following first-line sorafenib.
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Current guidelines recommend transarterial chemoembolization (TACE) as the standard treatment of Barcelona-Clinic Liver Cancer (BCLC)-B patients. However, the long-term survival outcomes of patients managed with this technique do not appear fully satisfactory; in addition, intermediate-stage hepatocellular carcinoma (HCC) includes a heterogeneous population of patients with varying tumour burdens, liver function and disease aetiology. Therefore, not all patients with intermediate-stage HCC may derive similar benefit from TACE, and some patients may benefit from other treatment options, which are currently approved or being explored. These include different TACE modalities, such as selective TACE or drug-eluting beads TACE and radioembolization. The introduction of sorafenib in the therapeutic armamentarium for HCC has provided a new therapeutic option for the treatment of BCLC-B patients who are unsuitable to TACE or in whom TACE resulted in unacceptable toxicity. In addition, clinical trials aimed at investigating the potential role of this molecule in the treatment of patients with intermediate-stage HCC within combination therapeutic regimens are ongoing. This narrative review will present and discuss the most recent evidence on the locoregional or medical treatment with sorafenib in patients with intermediate-stage HCC.
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A debate about Caster Semenya's female sex began shortly after the South African runner won gold in the women’s 800m final at the 2009 Athletic World Championships held in Berlin. Her victory was disputed through questions about her right to compete as a ‘woman’, with the International Association of Athletics Federation (IAAF) announcing she would be required to undergo a gender verification test before her victory could be confirmed. Using the theoretical frame of social constructionism (Berger & Luckmann), poststructuralism (Foucault), gender- and postcolonial theories (Butler; Hall; Spivak) and the methodology of critical discourse analysis (Jaeger), the paper explores the way the possible intersexuality of Caster Semenya was contextualised in mainstream Swiss German-language print media. The analyses will firstly look at the way in which Caster Semenya was constructed as a ʻfallen hero’ and stigmatised as a double-dealer and unacceptable deviant body. The rumours amongst athletes and commentators became news in the media, which focused on descriptions of her habitus, her muscular body and her deep voice. Through theoretical discussion the paper argues that the media response to Caster Semenya exemplifies Butler’s claim that the discursive framework of gender constructs and naturalises sex. A key question is therefore whether the designation of deviant bodies to a ʻfield of deformation’ (Butler) works to pluralise the field of gender, or rather, as Butler suggests, it tends that those bodies might call into questions. The final part of the paper discusses how gender, ethnicity and sexuality combine to constitute the black female sporting body as a spectacle of otherness. It is evident that this otherness is made manifest through the function of those bodies as a site of transgression, as the boundary between male and female, and often as the boundary between culture and nature (Hall). Using the example of the controversy surrounding Caster Semenya, this paper aims to demonstrate how the post/colonial white female body is reproduced by western norms of gender, sexuality, beauty and sporting behaviour, in the sense of a feminine sporting genderperformance. The media controversy will be also read through the lens of the globalisation of certain ideas of normative bodies, sex, ethnicity and gender and the challenge of changing stereotypes through transgression. Keywords: gender- and postcolonial theories, discourse analysis, print media, Caster Semen-ya, deviant body, ethnicity, intersexuality
Resumo:
A debate about Caster Semenya's female sex began shortly after the South African runner won gold in the women’s 800m final at the 2009 Athletic World Championships held in Berlin. Her victory was disputed through questions about her right to compete as a ‘woman’, with the International Association of Athletics Federation (IAAF) announcing she would be required to undergo a gender verification test before her victory could be confirmed. Using the theoretical frame of social constructionism (Berger & Luckmann), poststructuralism (Foucault), gender- and postcolonial theories (Butler; Hall; Spivak) and the methodology of critical discourse analysis (Jaeger), the paper explores the way the possible intersexuality of Caster Semenya was contextualised in mainstream Swiss German-language print media. The analyses will firstly look at the way in which Caster Semenya was constructed as a ʻfallen hero’ and stigmatised as a double-dealer and unacceptable deviant body. The rumours amongst athletes and commentators became news in the media, which focused on descriptions of her habitus, her muscular body and her deep voice. Through theoretical discussion the paper argues that the media response to Caster Semenya exemplifies Butler’s claim that the discursive framework of gender constructs and naturalises sex. A key question is therefore whether the designation of deviant bodies to a ʻfield of deformation’ (Butler) works to pluralise the field of gender, or rather, as Butler suggests, it tends that those bodies might call into questions. The final part of the paper discusses how gender, ethnicity and sexuality combine to constitute the black female sporting body as a spectacle of otherness. It is evident that this otherness is made manifest through the function of those bodies as a site of transgression, as the boundary between male and female, and often as the boundary between culture and nature (Hall). Using the example of the controversy surrounding Caster Semenya, this paper aims to demonstrate how the post/colonial white female body is reproduced by western norms of gender, sexuality, beauty and sporting behaviour, in the sense of a feminine sporting genderperformance. The media controversy will be also read through the lens of the globalisation of certain ideas of normative bodies, sex, ethnicity and gender and the challenge of changing stereotypes through transgression. Keywords: gender- and postcolonial theories, discourse analysis, print media, Caster Semen-ya, deviant body, ethnicity, intersexuality
Resumo:
Fractures of the growing bone require fixation techniques, which preclude any injury to the growth plate regions. This requirement is met by Elastic Stable Intramedullary Nails (ESIN) which are positioned between both metaphyseal regions. Pronounced malposition and/or shortening, open fractures and fractures with impending skin perforation are indications for clavicle nailing in adolescents. Retrograde nailing with two elastic nails, inserted from lateral, is the method of choice for stabilization of humerus fractures. In radial neck fractures with severe tilting of the radial head, a retrograde nail may reduce and fix the head. In Monteggia lesions, the ulna fracture is reduced and fixed with an antegrade nail. Forearm fractures with unacceptable axial deviation are reduced and fixed with one antegrade nail in the ulna and a retrograde nail in the radius. Ascending elastic nailing is done for femur shaft and proximal femur fractures. The medial and lateral entry sites are located above the distal physis. End caps are used to prevent shortening in spiral and multiple segment fractures. Fractures of the distal third of the femur are nailed in a descending technique. The entry sites of two nails are located on the lateral cortex below the greater trochanter. Combined tibia and fibula fractures, open fractures and unstable fracture types such as spiral and multifragmental tibia fractures are good indications for ESIN. Descending nailing is the method of choice. The nail entry points are medially and laterally distal to the apophysis of the proximal tibia. Thorough knowledge of each fracture type, fracture location and age specific healing pattern is necessary for safe and effective treatment of pediatric fractures
Resumo:
BACKGROUND Evidence suggests that cannabinoids can prevent chemotherapy-induced nausea and vomiting. The use of tetrahydrocannabinol (THC) has also been suggested for the prevention of postoperative nausea and vomiting (PONV), but evidence is very limited and inconclusive. To evaluate the effectiveness of IV THC in the prevention of PONV, we performed this double-blind, randomized, placebo-controlled trial with patient stratification according to the risk of PONV. Our hypothesis was that THC would reduce the relative risk of PONV by 25% compared with placebo. METHODS With IRB approval and written informed consent, 40 patients at high risk for PONV received either 0.125 mg/kg IV THC or placebo at the end of surgery before emergence from anesthesia. The primary outcome parameter was PONV during the first 24 hours after emergence. Secondary outcome parameters included early and late nausea, emetic episodes and PONV, and side effects such as sedation or psychotropic alterations. RESULTS The relative risk reduction of overall PONV in the THC group was 12% (95% confidence interval, -37% to 43%), potentially less than the clinically significant 25% relative risk reduction demonstrated by other drugs used for PONV prophylaxis. Calculation of the effect of treatment group on overall PONV by logistic regression adjusted for anesthesia time gave an odds ratio of 0.97 (95% confidence interval, 0.21 to 4.43, P = 0.97). Psychotropic THC side effects were clinically relevant and mainly consisted of sedation and confusion that were not tampered by the effects of anesthesia. The study was discontinued after 40 patients because of the inefficacy of THC against PONV and the finding of clinically unacceptable side effects that would impede the use of THC in the studied setting. CONCLUSIONS Because of an unacceptable side effect profile and uncertain antiemetic effects, IV THC administered at the end of surgery before emergence from anesthesia cannot be recommended for the prevention of PONV in high-risk patients.
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BACKGROUND AND AIMS Smoking is a crucial environmental factor in inflammatory bowel disease [IBD]. However, knowledge on patient characteristics associated with smoking, time trends of smoking rates, gender differences and supportive measures to cease smoking provided by physicians is scarce. We aimed to address these questions in Swiss IBD patients. METHODS Prospectively obtained data from patients participating in the Swiss IBD Cohort Study was analysed and compared with the general Swiss population [GSP] matched by age, sex and year. RESULTS Among a total of 1770 IBD patients analysed [49.1% male], 29% are current smokers. More than twice as many patients with Crohn's disease [CD] are active smokers compared with ulcerative colitis [UC] [UC, 39.6% vs CD 15.3%, p < 0.001]. In striking contrast to the GSP, significantly more women than men with CD smoke [42.8% vs 35.8%, p = 0.025], with also an overall significantly increased smoking rate compared with the GSP in women but not men. The vast majority of smoking IBD patients [90.5%] claim to never have received any support to achieve smoking cessation, significantly more in UC compared with CD. We identify a significantly negative association of smoking and primary sclerosing cholangitis, indicative of a protective effect. Psychological distress in CD is significantly higher in smokers compared with non-smokers, but does not differ in UC. CONCLUSIONS Despite well-established detrimental effects, smoking rates in CD are alarmingly high with persistent and stagnating elevations compared with the GSP, especially in female patients. Importantly, there appears to be an unacceptable underuse of supportive measures to achieve smoking cessation.
Resumo:
PURPOSE Rituximab maintenance therapy has been shown to improve progression-free survival in patients with follicular lymphoma; however, the optimal duration of maintenance treatment remains unknown. PATIENTS AND METHODS Two hundred seventy patients with untreated, relapsed, stable, or chemotherapy-resistant follicular lymphoma were treated with four doses of rituximab monotherapy in weekly intervals (375 mg/m(2)). Patients achieving at least a partial response were randomly assigned to receive maintenance therapy with one infusion of rituximab every 2 months, either on a short-term schedule (four administrations) or a long-term schedule (maximum of 5 years or until disease progression or unacceptable toxicity). The primary end point was event-free survival (EFS). Progression-free survival, overall survival (OS), and toxicity were secondary end points. Comparisons between the two arms were performed using the log-rank test for survival end points. RESULTS One hundred sixty-five patients were randomly assigned to the short-term (n = 82) or long-term (n = 83) maintenance arms. Because of the low event rate, the final analysis was performed after 95 events had occurred, which was before the targeted event number of 99 had been reached. At a median follow-up period of 6.4 years, the median EFS was 3.4 years (95% CI, 2.1 to 5.3) in the short-term arm and 5.3 years (95% CI, 3.5 to not available) in the long-term arm (P = .14). Patients in the long-term arm experienced more adverse effects than did those in the short-term arm, with 76% v 50% of patients with at least one adverse event (P < .001), five versus one patient with grade 3 and 4 infections, and three versus zero patients discontinuing treatment because of unacceptable toxicity, respectively. There was no difference in OS between the two groups. CONCLUSION Long-term rituximab maintenance therapy does not improve EFS, which was the primary end point of this trial, or OS, and was associated with increased toxicity.
Resumo:
BACKGROUND VEGF and VEGF receptor-2-mediated angiogenesis contribute to hepatocellular carcinoma pathogenesis. Ramucirumab is a recombinant IgG1 monoclonal antibody and VEGF receptor-2 antagonist. We aimed to assess the safety and efficacy of ramucirumab in advanced hepatocellular carcinoma following first-line therapy with sorafenib. METHODS In this randomised, placebo-controlled, double-blind, multicentre, phase 3 trial (REACH), patients were enrolled from 154 centres in 27 countries. Eligible patients were aged 18 years or older, had hepatocellular carcinoma with Barcelona Clinic Liver Cancer stage C disease or stage B disease that was refractory or not amenable to locoregional therapy, had Child-Pugh A liver disease, an Eastern Cooperative Oncology Group performance status of 0 or 1, had previously received sorafenib (stopped because of progression or intolerance), and had adequate haematological and biochemical parameters. Patients were randomly assigned (1:1) to receive intravenous ramucirumab (8 mg/kg) or placebo every 2 weeks, plus best supportive care, until disease progression, unacceptable toxicity, or death. Randomisation was stratified by geographic region and cause of liver disease with a stratified permuted block method. Patients, medical staff, investigators, and the funder were masked to treatment assignment. The primary endpoint was overall survival in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01140347. FINDINGS Between Nov 4, 2010, and April 18, 2013, 565 patients were enrolled, of whom 283 were assigned to ramucirumab and 282 were assigned to placebo. Median overall survival for the ramucirumab group was 9·2 months (95% CI 8·0-10·6) versus 7·6 months (6·0-9·3) for the placebo group (HR 0·87 [95% CI 0·72-1·05]; p=0·14). Grade 3 or greater adverse events occurring in 5% or more of patients in either treatment group were ascites (13 [5%] of 277 patients treated with ramucirumab vs 11 [4%] of 276 patients treated with placebo), hypertension (34 [12%] vs ten [4%]), asthenia (14 [5%] vs five [2%]), malignant neoplasm progression (18 [6%] vs 11 [4%]), increased aspartate aminotransferase concentration (15 [5%] vs 23 [8%]), thrombocytopenia (13 [5%] vs one [<1%]), hyperbilirubinaemia (three [1%] vs 13 [5%]), and increased blood bilirubin (five [2%] vs 14 [5%]). The most frequently reported (≥1%) treatment-emergent serious adverse event of any grade or grade 3 or more was malignant neoplasm progression. INTERPRETATION Second-line treatment with ramucirumab did not significantly improve survival over placebo in patients with advanced hepatocellular carcinoma. No new safety signals were noted in eligible patients and the safety profile is manageable. FUNDING Eli Lilly and Co.
Resumo:
BACKGROUND Imetelstat, a 13-mer oligonucleotide that is covalently modified with lipid extensions, competitively inhibits telomerase enzymatic activity. It has been shown to inhibit megakaryocytic proliferation in vitro in cells obtained from patients with essential thrombocythemia. In this phase 2 study, we investigated whether imetelstat could elicit hematologic and molecular responses in patients with essential thrombocythemia who had not had a response to or who had had unacceptable side effects from prior therapies. METHODS A total of 18 patients in two sequential cohorts received an initial dose of 7.5 or 9.4 mg of imetelstat per kilogram of body weight intravenously once a week until attainment of a platelet count of approximately 250,000 to 300,000 per cubic millimeter. The primary end point was the best hematologic response. RESULTS Imetelstat induced hematologic responses in all 18 patients, and 16 patients (89%) had a complete hematologic response. At the time of the primary analysis, 10 patients were still receiving treatment, with a median follow-up of 17 months (range, 7 to 32 [ongoing]). Molecular responses were seen in 7 of 8 patients who were positive for the JAK2 V617F mutation (88%; 95% confidence interval, 47 to 100). CALR and MPL mutant allele burdens were also reduced by 15 to 66%. The most common adverse events during treatment were mild to moderate in severity; neutropenia of grade 3 or higher occurred in 4 of the 18 patients (22%) and anemia, headache, and syncope of grade 3 or higher each occurred in 2 patients (11%). All the patients had at least one abnormal liver-function value; all persistent elevations were grade 1 or 2 in severity. CONCLUSIONS Rapid and durable hematologic and molecular responses were observed in patients with essential thrombocythemia who received imetelstat. (Funded by Geron; ClinicalTrials.gov number, NCT01243073.).
Resumo:
BACKGROUND Neuronavigation is an essential tool in cranial neurosurgery. Despite continuing improvements in the technologies used for neuronavigation, certain events can lead to unacceptable mismatches. To provide the best possible outcome for the patients, surgeons need to do everything possible to reduce mismatches. METHODS AND RESULTS Some simple techniques can greatly improve neuronavigation accuracy and patient safety. We describe two simple methods that were developed or refined in the Department of Neurosurgery at Inselspital, Bern, Switzerland: the transdermal navigation landmark and use of bone screws for co-registration. CONCLUSIONS Both techniques are easy to use, do not require expensive additional instruments, and are helpful in procedures involving neuronavigation.