Safe Criteria Research Articles

This baby is not for turning: Women's experiences of attempted external cephalic version.

BackgroundExisting studies regarding women’s experiences surrounding an External Cephalic Version (ECV) report on women who have a persistent breech post ECV and give birth by caesarean section, or on women who had successful ECVs and plan for a vaginal birth. There is a paucity of understanding about the experience of women who attempt an ECV then plan a vaginal breech birth when their baby remains breech. The aim of this study was to examine women’s experience of an ECV which resulted in a persistent breech presentation.MethodsA qualitative descriptive exploratory design was undertaken. In-depth semi-structured interviews were conducted and analysed thematically.ResultsTwenty two (n = 22) women who attempted an ECV and subsequently planned a vaginal breech birth participated. Twelve women had a vaginal breech birth (55 %) and 10 (45 %) gave birth by caesarean section. In relation to the ECV, there were five main themes identified: ‘seeking an alternative’, ‘needing information’, ‘recounting the ECV experience’, ‘reacting to the unsuccessful ECV’ and, ‘reflecting on the value of an ECV’.ConclusionsECV should form part of a range of options provided to women, rather than a default procedure for management of the term breech. For motivated women who fit the safe criteria for vaginal breech birth, not being subjected to a painful experience (ECV) may be optimal. Women should be supported to access services that support vaginal breech birth if this is their choice, and continuity of care should be standard practice.

The concept of treatment-free remission in chronic myeloid leukemia.

The advent of tyrosine kinase inhibitors (TKI) into the management of patients with chronic myeloid leukemia (CML) has profoundly improved prognosis. Survival of responders is approaching that of the general population but lifelong treatment is still recommended. In several trials, TKI treatment has been stopped successfully in approximately half of the patients with deep molecular response. This has prompted the development of a new concept in the evaluation of CML patients known as ‘treatment-free remission'. The future in CML treatment will be to define criteria for the safe and most promising discontinuation of TKI on one hand, and, on the other, to increase the number of patients available for such an attempt. Until safe criteria have been defined, discontinuation of therapy is still experimental and should be restricted to clinical trials or registries. This review will provide an overview of current knowledge as well as an outlook on future challenges.

토조실험과 수치해석을 이용한 막장면 그라우팅 DSM공법의 안정성 검토

도심지에서는 고도의 경제성장과 더불어 증가되는 교통량을 수용하기 위하여 도로와 철도 신설에 따른 지하터널 공사가 활발히 진행되고 있다. 지하공간 개발에서는 토사터널 구간이 많을 수 있고 이에 따른 막장 및 천단부 안정성을 고려한 여러 공법들이 개발 적용되고 있다. 그 중 최근에 적용예가 많은 공법으로 DSM(divided shield method)를 들 수 있는데, 이는 Messer Shield 공법에 근간을 두고 있으며, Messer Shield 공법의 장점을 흡수하고 문제점을 개선하여 안정성 및 시공성을 크게 개선한 비개착 특수터널 공법이다. 이 연구에서는 DSM 공법에서 터널 막장면 그라우팅이 터널의 시공성 향상에 미치는 영향을 대형 토조와 수치해석을 수행하여 검토하였다. 실제도로 크기의 1/2인에 해당하는 터널을 모사하기 위한 토조를 제작하여 실험 수행하였다. 또한 MIDAS GTS를 사용하여 수치해석 분석을 통해 DSM모사 토조의 지반 거동과 비교하였다. 터널 표면 침하와 안정성을 단계별 굴착을 통해 측정하였으며, 수치해석과 비교분석하였다. 연구 결과 그라우팅을 통한 막장 안정을 지표의 침하뿐만 아니라 터널 각 부재의 응력은 모두 안정성 범위에 들어가 있었으며, 이를 통하여 DSM 공법의 기술을 개선하고 터널의 안정성 및 시공성 향상을 기대할 수 있는 기초자료를 확보하였다. In urban areas, underground tunnel construction sites have spread widely to accommodate rapidly increasing traffic volume along with a high-degree economic growth. Earth tunneling might be adapted frequently for the underground space securing, and various tunneling methods have been developed to stabilize the tunnel face and crown. Among them, the DSM (divided shield method) is gaining popularity for its enhanced stability and construction efficiency. This method has its foundation from the Messer Shield method, which is one of the trenchless special tunneling methods. This study examined the effects of face reinforcement on construction the sequence through a large scale soil chamber test and numerical analyses. The chamber has a size of a 1/2 scale of the real tunnel. Surface settlements were measured according the tunneling process. Commercially available software, MIDAS GTS, was used for numerical analysis and its result was compared with the values obtained from the chamber test. The results of the study show that both settlements of the embanked soils and the stress of the tunnel girder are located within the safe criteria. Overall, this study provides basic data and the potential of using a reinforced tunnel face to enhance DSM applications.

Early discharge after total thyroidectomy: a retrospective feasibility study.

The continued hospitalization after total thyroidectomy is often due to the onset of hypocalcemic complications more than 24 hours after surgery. So it would be important to predict which patients will not develop the hypocalcemic complication to discharge them early. This was the aim of our study. Our retrospective study was conducted on 327 consecutive thyroidectomized patients, operated on for benign and malignant diseases. We evaluated the values of preoperative serum calcium levels (Cal0) and of the first postoperative day (Cal1) and two new variables were calculated (dCal and dCaln). The same thing was made on a subgroup of 111 patients in whom also parathiroyd hormone (PTH) values were detected. Statistical analysis was performed with the goal of determining if we could establish a safe criterion for discharge at 24 hours after surgery and if there is a correlation between suitability for discharge and diagnosis. As to discharge, the predictive power of the discriminant function applied was significant both on the total of patients and in the subgroup of 111 patients, but it was clinically unacceptable because it would expose us to a 21% to 27% error rate. It is not possible to identify a threshold, below which to consider patients surely dischargeable. The diagnosis does not appear correlated with the suitability for discharge. On the basis of serum calcium and PTH levels in the first postoperative day, it is impossible to predict which patients can be discharged 24 hours after surgery without incurring in hypocalcemic complications.

Defining safe criteria to diagnose miscarriage: prospective observational multicentre study

Objectives To validate recent guidance changes by establishing the performance of cut-off values for embryo crown-rump length and mean gestational sac diameter to diagnose miscarriage with high levels of certainty....

Expert consensus and recommendations on safety criteria for active mobilization of mechanically ventilated critically ill adults.

IntroductionThe aim of this study was to develop consensus recommendations on safety parameters for mobilizing adult, mechanically ventilated, intensive care unit (ICU) patients.MethodsA systematic literature review was followed by a meeting of 23 multidisciplinary ICU experts to seek consensus regarding the safe mobilization of mechanically ventilated patients.ResultsSafety considerations were summarized in four categories: respiratory, cardiovascular, neurological and other. Consensus was achieved on all criteria for safe mobilization, with the exception being levels of vasoactive agents. Intubation via an endotracheal tube was not a contraindication to early mobilization and a fraction of inspired oxygen less than 0.6 with a percutaneous oxygen saturation more than 90% and a respiratory rate less than 30 breaths/minute were considered safe criteria for in- and out-of-bed mobilization if there were no other contraindications. At an international meeting, 94 multidisciplinary ICU clinicians concurred with the proposed recommendations.ConclusionConsensus recommendations regarding safety criteria for mobilization of adult, mechanically ventilated patients in the ICU have the potential to guide ICU rehabilitation whilst minimizing the risk of adverse events.

Infections in HIV-exposed uninfected children with focus on sub-Saharan Africa.

Infections in HIV-exposed uninfected children with focus on sub-Saharan Africa.

인간의 인지적 감각을 이용한 휴대용 미끄럼 측정기의 성능평가

The objectives of this study were to evaluate the safe criteria of portable slipmeter using human perception onto the several different floor surfaces under contaminated conditions. It was difficult to find why many different slipmeters took there's own safe criteria. It is still unclear how thres hold values established in many literatures. Two different subjective slippery evaluating methods, AHP(Analytic Hierarchy Process) and Friedman test,were used to evaluate the perception of slipperiness of seven different floor surfaces under the contaminated condition with detergent solution. Twelve subjects worn same footwear and walked with self-selected step and cadence along the test floors. The SCOF(Static Coefficient of Friction) obtained for same test conditions with BOT-3000 was compared to perception of slipperiness to establish as a safe criteria. The very high significant correlation(r=0.97) was found between AHP and Friedman test. Also, The high significant correlation(r=0.96) was found between AHP and SCOF obtained with BOT-3000. The results suggested that the SCOF should be greater than 0.63 for safer walking. Perception rating obtained with AHP showed a high correlation with Friedman test and the SCOF obtained with BOT-3000 except for polished tile floor. The safe criteria obtained through this study were similar to ANSI/NFSIB101.1.

Polycyclic aromatic hydrocarbons (PAHs) in the mariculture zones of China’s northern Yellow Sea

Polycyclic aromatic hydrocarbons (PAHs) were detected in water and sediment samples collected from three mariculture zones in China’s northern Yellow Sea. In these samples, total PAH concentrations ranged from 110.8ng/L to 997.2ng/L and 142.2ng/gdry weight (dw) to 750.2ng/gdw, respectively. The log KOC values of the various PAH compounds examined in this study increased with the log KOW values, which is consistent with the prediction regarding PAH behavior in the environment. However, these KOC values were lower than the predicted values as a result of the effects of organic matters, which were abundant in the mariculture water. The isomeric ratios of the PAHs in sediment indicated that the source of the PAHs in the mariculture zones were mainly pyrolytic. The TEQcarc values of PAHs ranged from 7ng TEQ/gdw to 92ng TEQ/gdw, and only a few samples met the safe criterion with respect to individual PAH concentrations.

Experimental investigation and modelling of the structural behaviour of confined grouted interfaces for a new steel–concrete connection

Confined interfaces between cement grout and other materials such as embossed steel or rough concrete are formed in an innovative new steel-concrete connection for composite bridges. This article presents the experimental study of such interfaces and investigates the laws obtained from an analytical study, which describe the behaviour of those interfaces subjected to shear loading, static and cyclic, under different levels of constant normal stress. The laws describing the interface behaviour in monotonic shear loading are: (a) the relationship between the ultimate shear and the normal stress acting on the interface, i.e. the failure criterion, (b) the shear stress–slip relationship of the interface, called hereafter the constitutive law and (c) the relationship between the transverse separation (uplift) of the interface and the slip in the interface, called hereafter kinematic law. Concerning cycle shear loading, tests on interfaces enabled damage determination due to repeated loading. This damage is expressed by the development of an accumulated residual slip in the interface. Results indicate that as long as the applied shear stress in the interface, during cyclic loading, remains inferior to the elastic shear limit for static loading, the residual slip stabilizes with the number of cycles. A safe fatigue failure criterion is proposed relating the accumulated slip with the value of the slip at shear failure of the interface for static loading. The proposed laws together with the law describing the development of the confinement constitute the necessary input for a model to predict the behaviour of an innovative connection consisting of such confined grouted interfaces.

A study of safe criteria for radical trachelectomy in cervical cancer patients to prevent recurrence and catastrophic consequences: A multicenter study

A study of safe criteria for radical trachelectomy in cervical cancer patients to prevent recurrence and catastrophic consequences: A multicenter study

A Criterion of the Strain-Based Quench Decision for a Low-Temperature Superconducting Solenoid

It is important to pursue an efficacious way of detecting the quench in superconducting magnets as soon as possible so that the large magnetic energy stored in the magnets can be discharged duly. By means of strain measurement during the spontaneous quench, we recently proposed a quench-detection method for low-temperature superconducting solenoid magnets. By examining the leap character of strain-rate recorded, we further extended the strain-based quench-detection method. An appropriate criterion for the spontaneous quench was suggested and utilized for two liquid helium-cooled superconducting solenoids with different sizes and coil configurations. It was shown that the proposed method is capable of providing a safe criterion for the quench detection/protection within a short period of time, and it is a simple process comparing with the rate of quench development. The experimental data from the two different solenoids under excitation and quench tests supported the new strain-based detection method.

해상풍력발전단지의 대체통항로 통항안전성 평가에 관한 연구

In this paper, we analysed vessel traffic volume and patterns of traffic flow for ships using areas where included wind farm site and adjacent waters of Daejeong Offshore Wind Farm, and estimated traffic volume by classified navigational routes according to suggestion of rational routeing measures on the basis of classified patterns after installation of offshore wind facilities. Also, we assessed vessel traffic safety for each designed routeing measures on the basis of estimated traffic volume and proposed requisite countermeasures for the safe navigation of ships. With a result of analysing patterns of traffic flow, the current traffic flow was classified by 8 patterns and the annual traffic volume was predicted to 8,975 ships. On the basis of these, expected the vessel traffic volume according to designed four routeing mesaures after installation of wind farm. As result of assessing vessel traffic safety by using powered-vessel collision model of SSPA on the basis of the estimated traffic volume, the value of collision probability was less than safe criteria 10 -4 . Thereby we made sure usability of the designed routeing measures for the safe navigation of ships.

Experimental Research on the Character of Resist Explosion for Reinforced Concrete Structure of Sand Filling

Explosion containment structure (chamber) is used to protect personnel and experimental equipment during the destruction of explosion environmental for research blasting or disposal exploder. Reinforced concrete has advantiage of low cost and simple process in buliding ,so it was usually used of buliding the structure of resist explosion.This paper demonstrates reinforced concrete structures character of resist explosion under envirmonent of filling sand,the hoop strain of structure central cross section were measured loaded by different mass explosive charges,the safe criterion of reinforced concrete structure was obtained. Loaded by the explosion,the damage mechanics of reinforced concrete structure that diameter equal to height was analysed,and the method for avoiding the structure fail was suggest.

Scope for Groundwater Development in North West Region of Bangladesh

Due to decreasing trend of river flow and increasing demand of water for irrigation, domestic and other purposes, it is an urgent need to investigate the scope of ground water (GW) development within safe yield criteria. Surface water (SW) and groundwater is a part and parcel of the hydrological cycle. So it is essential to consider both the ground and surface water in an integrated approach and this can be done using physically distribute mathematical modeling tools. In this paper, a case study was carried out for Panchagarh, Thakurgaon, Dinajpur and Joypurhat Districts which is situated in the north-west region of Bangladesh using physically distributed hydrological modelling. With the existing irrigation facilities, it was possible to bring only about 40% of the total cultivable land under irrigation. To bring more potential land under irrigation through sustainable water resources management, an integrated GW-SW model was developed using mathematical modelling software MIKE-11 and MIKE-SHE which was calibrated for the period 2003-2007 and validated for the period 2008-2009. Using model result, groundwater and surface water resources, possible expansion of irrigation coverage and a zoning map suitable for different mode irrigation equipment for the study area was assessed along with requirement of additional number of Deep Tube Well (DTW). Considering the scarcity of SW and safe yield criteria the potential GW was identified and additional 4803 DTWs of 2 cusec capacity for 28 Upazilas to cover the future demand. As a result irrigation coverage as well as agricultural production would be increased considerably if the project is implemented following the study findings and suggestions. Some area were also been identified which is potential for surface water irrigation. The economic analysis shows minimum EIRR value of 29.85% when all costs increase by 30%. So the study output has positive impact and for sustainable water resources management it is very essential to use the state-of -the art technology.

Loss of Major Molecular Response As a Trigger for Restarting Tyrosine Kinase Inhibitor Therapy in Patients With Chronic-Phase Chronic Myelogenous Leukemia Who Have Stopped Imatinib After Durable Undetectable Disease

More than half of patients with chronic-phase chronic myelogenous leukemia (CP-CML) in complete molecular response (CMR) experience molecular relapse after imatinib discontinuation. We investigated loss of major molecular response (MMR) as a criterion for resuming therapy. A multicenter observational study (A-STIM [According to Stop Imatinib]) evaluating MMR persistence was conducted in 80 patients with CP-CML who had stopped imatinib after prolonged CMR. Median time from imatinib initiation to discontinuation was 79 months (range, 30 to 145 months);median duration of CMR before imatinib discontinuation was 41 months (range, 24 to 96 months); median follow-up after discontinuation was 31 months (range, 8 to 92 months). Twenty-nine patients (36%) lost MMR after a median of 4 months off therapy (range, 2 to 17 months). Cumulative incidence of MMR loss was estimated as 35% (95% CI, 25% to 46%) at 12 months and 36% (95% CI, 26% to 47%) at 24 months, whereas probability of losing CMR was higher. Fluctuation of BCR-ABL transcript levels below the MMR threshold (≥ two consecutive positive values) was observed in 31% of patients after imatinib discontinuation. Treatment-free remission was estimated as 64% (95% CI, 54% to 75%) at 12 and 24 months and 61% (95% CI, 51% to 73%) at 36 months. Median to time to second CMR was estimated as 7.3 months in re-treated patients. Loss of MMR is a practical and safe criterion for restarting therapy in patients with CML with prolonged CMR.

Loss Of Major Molecular Response As a Trigger For Restarting Tyrosine Kinase Inhibitor Therapy In CP-CML Patients Who Have Stopped Imatinib After Durable Undetectable Minimal Residual Disease

PurposeMore than half of patients with chronic phase chronic myelogenous leukemia (CP-CML) in complete molecular response (CMR) experience molecular relapse after imatinib discontinuation. We investigated loss of major molecular response (MMR) as a criterion for resuming therapy. Patients and methodsA multicenter observational study (A-STIM, According to STop IMatinib) evaluating MMR persistence was conducted in 80 CP-CML patients who had stopped imatinib after prolonged confirmed CMR (24 months or more). Patients with confirmed CMR with 1 or 2 occasional weak positive samples before study entry were also considered eligible. CMR was defined as undetectable BCR-ABL transcript with a sensitivity of at least 40000 amplified copies of the ABL control gene, in accordance with the level of sensitivity routinely applied within laboratories participating in the French GBMHM Network. ResultsMedian time from imatinib initiation to discontinuation was 79 months (range 30-145), median duration of CMR before imatinib discontinuation was 41 months (24-96), and median follow-up after discontinuation was 31 months (8-92). Twenty-nine patients (36%) lost MMR after a median of 4 months off-therapy (2-17). Cumulative incidence of MMR loss was estimated as 35% (95% CI, 25%-46%) at 12 months and 36% (95% CI, 26%-47%) at 24 months whereas probability of losing CMR was estimated as 51% at 12 months (95% CI, 41%-63%) and 54% at 24 months (95% CI, 44%-66%). Fivety two percent of the patients met the criteria for cCMR but experienced occasional BCR-ABL positivity (unstable cCMR). Those patients were not at higher risk of losing MMR as compared to patients with stable cCMR. This observation may potentially increase by two-fold the number of patients eligible for TKI discontinuation. Fluctuation of BCR-ABLtranscript levels below the MMR threshold (≥ 2 consecutive positive values) were observed in 31% of patients after imatinib discontinuation. Using cell sorting in three fluctuating patients, we were able to confirm that BCR-ABL signal was mostly present in the CD15 positive fraction, demonstrating first that BCR-ABL residual signal was not related to long living lymphoid cells and second that residual CML cells retain a clonogenic potential. Treatment-free remission was estimated as 64% (95% CI, 54%-75%) at 12 and 24 months and 61% (95% CI, 51%-73%) at 36 months. Treatment was resumed in 31 patients after loss of MMR. Twenty-three patients regained CMR4.5 and 8 patients are in MMR under therapy after 2+ to 17+ months. Median to time to a second CMR was estimated as 7.3 months in retreated patients. ConclusionThe probability of losing MMR after imatinib discontinuation was estimated as 36% in the long-term. Loss of MMR is a practical and safe criterion for restarting therapy in CML patients with prolonged CMR and could be used for future discontinuation studies. Disclosures:Rousselot:Novartis: Research Funding; BMS: Research Funding. Cony-Makhoul:BMS: Honoraria; Novartis: Research Funding. Nicolini:BMS, Teva, Ariad, Pfizer, Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Etienne:Novartis: Consultancy; Pfeizer: Consultancy; Novartis: Honoraria; BMS: Honoraria. Guerci-Bresler:Novartis: Membership on an entity's Board of Directors or advisory committees; BMS: Membership on an entity's Board of Directors or advisory committees. Turhan:BMS: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees; BMS: Honoraria; Novartis: Research Funding. Guilhot:BMS: Consultancy; Novartis: Consultancy; Ariad: Consultancy; Pfizer: Consultancy; BMS: Research Funding; Novartis: Research Funding. Mahon:Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Brisol Myers Squibb: Consultancy, Honoraria; Ariad: Honoraria; Pfizer: Honoraria.

Medical geochemical investigations in taking precautionary measures against diseases. Protection and human health

A considerable number of diseases are directly related to environmental impact. Toxic metals such as Hg, Pb, Cd, and As may damage significantly the human health when they exceed certain levels in the body. For example specific precautions should be taken for the diet of pregnant women and the children. Lead concentrations exceeding the safe values can cause severe damage to the development of central nervous system, as well as a general developmental delay of fetuses and young children, interfering with the functioning of almost every brain neurotransmitter. In particular for the pregnant women, it has been found that the exposure of the fetus on high lead values may cause, apart from neurological and behavioral problems, low birth weight, pre-term delivery, spontaneous abortion and stillbirth. Organic mercury (methyl mercury) is the most dangerous form of mercury, because it is the most easily absorbed orally and crosses into the brain and fetus so readily. Populations exposed to chemical compounds containing As, Ni, Cr, Cd, etc. are considered of high-risk in developing cancer. Environmental geochemical studies can help in assessing the quality of the environment as well as the determination of the sources of pollutants, their behaviour and other characteristics. This knowledge is necessary in any application of remediation methodologies and waste management for the prevention of pollutants in getting into the food chain. It is also used in determining safe criteria regarding the quality of soils, drinking water, construction of schools, playgrounds etc. In this work the importance of environmental geochemical research and its applications towards the protection of human health is demonstrated.

A Double-Blind, Placebo-Controlled Study of Aripiprazole Adjunctive to Antidepressant Therapy among Depressed Outpatients with Inadequate Response to Prior Antidepressant Therapy (ADAPT-A Study)

Background: We assessed the efficacy of low-dose aripiprazole added to antidepressant therapy (ADT) in major depressive disorder (MDD) patients with inadequate response to prior ADT. Methods: As per the sequential parallel comparison design, 225 MDD subjects were randomized to adjunctive treatment with aripiprazole 2 mg/day or placebo across two 30-day phases, with a 2:3:3 randomization ratio to drug/drug (aripiprazole 2 mg/day in phase 1; 5 mg/day in phase 2), placebo/placebo (placebo in both phases), and placebo/drug (placebo in phase 1; aripiprazole 2 mg/day in phase 2). Eligible subjects were patients whose MDD was independently deemed ‘valid’ with SAFER criteria. Subjects had been receiving ADT for ≥8 weeks, and had inadequate response to ≥1 and <4 adequate ADTs in the current episode, as defined by the Antidepressant Treatment Response Questionnaire. Results: The pooled, weighted response difference between aripiprazole 2 mg/day and placebo in the two phases was 5.6% (p = 0.18; NS). The aripiprazole 2 mg/day-placebo difference on the Montgomery-Asberg Depression Rating Scale pooled across the two phases was –1.51 (p = 0.065; NS). Other secondary endpoint analyses showed nonsignificant pooled differences favoring aripiprazole over placebo. Of the 225 randomized subjects in phase 1, 2 dropped out in both arms, while in phase 2, of 138 phase 1 placebo nonresponders, 9 dropped out on aripiprazole and 5 on placebo. There were only minimal differences in adverse event rates between treatments, except for constipation, weight gain, and dry mouth, more common on aripiprazole. Conclusions: This study provides clear support for the tolerability of low-dose aripiprazole as an ADT-augmenting agent, with marginal efficacy.

Study on criterion for quench detection/protection of superconducting magnet based on active power method

When a quench occurs in a superconducting magnet, excessive joule heating in normal region may damage the magnet. It is important to detect the quench in the magnet as soon as possible and discharge magnetic energy stored in the magnet. The authors have proposed a quench detection/protection system based on active power method which detects an active power dissipated in the magnet after the quench. In this paper, the authors propose a method to decide an appropriate criterion to protect the magnet from the excessive joule heating by using 1D heat equation. The method can determine a safe criterion for the quench detection/protection within a short time. The authors show the usefulness of the method through experimental results for high temperature superconducting coils.