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1.

Background

Adolescent HIV patients face enormous difficulty in accessing HIV care services. Given their vulnerability to risk-taking behaviour, this group also have worse treatment outcomes compared to other age groups. Poor treatment outcomes will impact negatively on HIV/AIDS management and control particularly in sub-Saharan Africa (SSA) as more than eight out of ten of the world’s HIV-infected adolescents live in this region of the world. Limited evidence exists on the effectiveness of service delivery interventions to support adolescents’ retention on antiretroviral therapy (ART) and adherence to ART. This trial is designed to evaluate the impact of conditional economic incentive and motivational interviewing on adolescents’ retention in HIV care and adherence to ART in Anambra State, Southeast Nigeria.

Methods/design

The study will be a cluster randomised controlled trial that will be conducted in selected HIV treatment hospitals in Anambra State, Nigeria. Based on sample size calculation, 12 HIV treatment hospitals from Anambra will be selected for the study. Six HIV treatment hospitals each will be randomised to either the intervention or the control arm. A structured adherence support scheme termed the ‘Incentive Scheme’ will be applied to the intervention arm while the control arm will receive routine HIV care (usual care). Additionally, patients in the intervention arm will receive motivational interviewing at baseline and following initiation of antiretroviral therapy (ART), they will receive a gift voucher of US$5.6 when HIV viral load (VL) is <?20 copies/mL at 12?weeks, a gift voucher of US$2.8 if the VL remains suppressed for the next 3?months, and the next 6?months, and finally a gift voucher of US$5.6 if the VL remains <?20 copies/mL at 1?year. All gift vouchers will be conditional not only on VL results but attending the motivational interviews. The primary outcome for the trial will be the difference between groups in the proportion with HIV VL suppression (≤?20 copies/mL) by 12?months and then 24?months after withdrawal of incentive.

Discussion

The findings of this proposed trial will provide evidence on the feasibility of applying conditional economic incentives combined with motivational interviewing to improve retention and adherence to antiretroviral therapy of adolescents living with HIV in Nigeria and possibly in other sub-Saharan African countries.

Trial registration

Registered in the Pan African Clinical Trials Registry, ID: PACTR201806003040425. Registered on 2 February 2018.
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2.
BackgroundEndovenous thermal techniques, such as endovenous laser ablation (EVLA), are the recommended treatment for truncal varicose veins. However, a disadvantage of thermal techniques is that it requires the administration of tumescent anaesthesia, which can be uncomfortable. Non-thermal, non-tumescent techniques, such as mechanochemical ablation (MOCA) have potential benefits. MOCA combines physical damage to endothelium using a rotating wire, with the infusion of a liquid sclerosant. Preliminary experiences with MOCA showed good results and less post-procedural pain.Methods/DesignThe Laser Ablation versus Mechanochemical Ablation (LAMA) trial is a single-centre randomised controlled trial in which 140 patients will be randomly allocated to EVLA or MOCA. All patients with primary truncal superficial venous insufficiency (SVI) who meet the eligibility criteria will be invited to participate in this trial. The primary outcomes are intra-procedural pain and technical efficacy at 1 year, defined as complete occlusion of target vein segment and assessed using duplex ultrasound. Secondary outcomes are post-procedural pain, analgesia use, procedure time, clinical severity, generic and disease-specific quality of life, bruising, complications, satisfaction, cosmesis, time taken to return to daily activities and/or work, and cost-effectiveness analysis following EVLA or MOCA. Both groups will be evaluated on an intention-to-treat basis.DiscussionThe aim of the LAMA trial is to establish whether MOCA is superior to the current first-line treatment, EVLA. The two main hypotheses are that MOCA may cause less initial pain and disability allowing a more acceptable treatment with an enhanced recovery. The second hypothesis is that this may come at a cost of decreased efficacy, which may lead to increased recurrence and affect longer term quality of life, increasing the requirement for secondary procedures.

Trial registration

ClinicalTrials.gov identifier: NCT02627846, registered 8 December 2015EudraCT number: 2015-000730-30REC ref: 15/YH/0207R&D ref: R1788  相似文献   

3.
Burnout and stress-related mental disorders (depression, anxiety) occur in medical students and physicians with a significantly higher prevalence than in the general population. At the same time, the learning of coping mechanisms against stress is still not an integral part of medical education. In this pilot study we developed an elective course for learning relaxation techniques and examined the condition of the students before and after the course. 42 students participated in the semester courses in 2012 and 2013 as well as in a survey at the start and end of each course. The students were instructed in autogenic training (AT) and progressive muscle relaxation according to Jacobsen (PMR) with the goal of independent and regular exercising. At the beginning and the end of the semester/course the students were interviewed using standardized, validated questionnaires on burnout (BOSS-II) and anxiety (STAI-G), depression (BDI), quality of life (SF-12) and sense of coherence (SOC-L9). We compared the results of our students participating in Relacs with results from eight semester medical students (n = 88), assessed with the same questionnaires at similar points of time within their semester. Participating students showed a significant decline in cognitive and emotional burnout stress and in trait anxiety. Furthermore, they showed a reduction in state anxiety and a conspicuous decrease in mean depression. The sense of coherence increased at the same time. A comparative cohort of medical students of 8th semester students, showed lower values for the specified measurement parameters at the beginning, but showed no progressive changes. Our course introducing AT and PMR led to a significant reduction of burnout and anxiety within the participating group of medical students. Even the course attendance for just one semester resulted in significant improvements in the evaluated parameters in contrast to those students who did not attend the course.  相似文献   

4.
Lakes can be monitored using different bioindicators, among which phytoplankton and benthic diatoms. We compared these two indicators in Lake Geneva for nutrient assessment. Bimonthly samplings were carried out during one year in the euphotic layer of a pelagic site. In the same time four littoral sites were sampled at 40–50 cm depth. Species compositions and abundances of both bioindicators were analyzed following European standards. Water physico-chemical composition was analyzed at the same time. Seasonal succession of benthic diatom guilds was observed. The dynamics of benthic diatom communities were better correlated to the pelagic chemistry than to the local littoral chemistry. We also observed that in the sampling sites frequently exposed to winds and waves, benthic diatoms showed lower correlations to physico-chemical dynamics, because of an increase of pioneer diatoms abundance adapted to turbulent environment, such sites must be avoided for lake monitoring. Finally, biotic indices calculated with benthic diatoms in wind protected sites showed higher correlations with pelagic nutrient concentration (PO43−) than indices calculated with phytoplankton. This unexpected situation can be explained by differences of temporal variability of chemical and biological compartments. Littoral chemistry changed faster than pelagic chemistry because of rains, diffuse flow from watershed and rivers flowing in the littoral zone whereas pelagic chemistry has a much smoother evolution because it is situated 10 km from the coast. But phytoplankton showed a high temporal variability because of wind influence, which explained the low correlation with the smooth evolution of pelagic chemistry. On the other hand, benthic diatoms from sites protected from the dominant wind, showed a lower temporal variability and were more in synchrony with the smooth evolution of pelagic chemistry.Even if we show that diatom seem to be promising indicator of nutrient level of the lake, we also underline the complementarity of using both indicators: benthic diatom and phytoplankton. Each of them brings different information about temporal variability of the lake and about the functioning of different habitats. Comparing these two bioindicators only on the basis of nutrient correlation ability would be an over-simplification whom managers must be warned.  相似文献   

5.

Background

We tested the hypothesis that ventilatory drive in hypoxia and hypercapnia is inversely correlated with the number of hypopneas and obstructive apneas per hour of sleep (obstructive apnea hypopnea index, OAHI) in children.

Methods

Fifty children, 6 to 12 years of age were studied. Participants had an in-home unattended polysomnogram to compute the OAHI. We subsequently estimated ventilatory drive in normoxia, at two levels of isocapnic hypoxia, and at three levels of hyperoxic hypercapnia in each subject. Experiments were done during wakefulness, and the mouth occlusion pressure measured 0.1 seconds after inspiratory onset (P0.1) was measured in all conditions. The slope of the relation between P0.1 and the partial pressure of end-tidal O2 or CO2 (PETO2 and PETCO2) served as the index of hypoxic or hypercapnic ventilatory drive.

Results

Hypoxic ventilatory drive correlated inversely with OAHI (r = -0.31, P = 0.041), but the hypercapnic ventilatory drive did not (r = -0.19, P = 0.27). We also found that the resting PETCO2 was significantly and positively correlated with the OAHI, suggesting that high OAHI values were associated with resting CO2 retention.

Conclusions

In awake children the OAHI correlates inversely with the hypoxic ventilatory drive and positively with the resting PETCO2. Whether or not diminished hypoxic drive or resting CO2 retention while awake can explain the severity of sleep-disordered breathing in this population is uncertain, but a reduced hypoxic ventilatory drive and resting CO2 retention are associated with sleep-disordered breathing in 6–12 year old children.  相似文献   

6.
The paper presents a new index for assessing water trophy and organic pollution. It is based on only true aquatic macrophytes – being calculated on species score, coefficient of ecological amplitude and degree of cover. The method was tested in an acidic lowland river and an alkaline mountain river, and is shown to be validated by bio-indication scales based on macrophyte communities. The practical interest is discussed regarding the Water Framework Directive. Electronic Supplementary Material Electronic supplementary material is available for this article atand accessible for authorised users.  相似文献   

7.

Background

Most patients with antihypertensive medication do not achieve their blood pressure (BP) target. The most important factor behind this failure is poor medication adherence. However, non-adherence to therapy does not concern only patients. Clinicians also tend to lack adherence to hypertension guidelines, overestimate BP control and be satisfied with inadequate BP control. The aim of this non-blinded, cluster-randomised, controlled study was to investigate if using a checklist would improve the quality of care in the initiation of new antihypertensive medication and help reduce non-adherence.

Methods

The study was conducted in eight primary care study centres in Central Finland, randomised to function as either intervention (n?=?4) or control sites (n?=?4). We included patients aged 30–75?years who were prescribed antihypertensive medication for the first time. Initiation of medication in the intervention group was carried out with a 9-item checklist, filled in together by the treating physician and the patient. Hypertension treatment in the control group was managed by the treating physician without a study-specific protocol.

Results

In total, 119 patients were included in the study, of which 118 were included in the analysis (n?=?59 in the control group, n?=?59 in the intervention group). When initiating antihypertensive medication, an adequate BP target was set for 19% of the patients in the control group and for 68% in the intervention group. Shortly after the appointment, only 14% of the patients in the control group were able to remember the adequate BP target, compared with 32% in the intervention group. The use of the checklist was also related to more regular agreement on the next follow-up appointment (64% in the control group versus 95% in the intervention group). No adverse events or side effects were related to the intervention.

Conclusions

Even highly motivated new hypertensive patients in Finnish primary care have significant gaps in their informational and behavioural skills. The use of a checklist for initiation of antihypertensive medication was related to significant improvement in these skills. Based on our findings, the use of a checklist might be a practical tool for addressing this problem.

Trial registration

NCT02377960. Date of registration: February 26th, 2015.
  相似文献   

8.
ABSTRACT: BACKGROUND: There is evidence to suggest that delivery of diabetes self-management support by diabetes educators in primary care may improve patient care processes and patient clinical outcomes; however, the evaluation of such a model in primary care is nonexistent in Canada. This article describes the design for the evaluation of the implementation of Mobile Diabetes Education Teams (MDETs) in primary care settings in Canada. METHODS: This study will have a non-blinded, cluster-randomized controlled trial stepped wedge design. A cluster, randomized controlled trial will be used to evaluate the Mobile Diabetes Education Teams' intervention in improving patient clinical and care process outcomes. A total of 1,200 patient charts at participating primary care sites will be reviewed for data extraction. Eligible patients will be those aged >=18, who have type 2 diabetes and a hemoglobin A1c (HbA1c) of >=8 %. Clusters (that is, primary care sites) will be randomized to the intervention and control group using a block randomization procedure within practice size as the blocking factor. A stepped wedge design will be used to sequentially roll out the intervention so that all clusters eventually receive the intervention. The time at which each cluster begins the intervention is randomized to one of the four roll out periods (0, 6, 12, and 18 months). Clusters that are randomized into the intervention later will act as the control for those receiving the intervention earlier. The primary outcome measure will be the difference in the proportion of patients who achieve the recommended HbA1c target of <=7 % between intervention and control groups. Qualitative work (in-depth interviews with primary care physicians, MDET educators and patients; and MDET educators' field notes and debriefing sessions) will be undertaken to assess the implementation process and effectiveness of the MDET intervention.Trial registrationClinicalTrials.gov NCT01553266.  相似文献   

9.
Diabet. Med. 29, 1260-1267 (2012) ABSTRACT: Aims Evaluate dose-dependent effects of once-weekly dulaglutide, a glucagon-like peptide-1 analogue, on glycaemic control in patients with Type?2 diabetes treated with lifestyle measures with or without previous metformin. Methods This 12-week, double-blind, placebo-controlled, dose-response trial randomized 167 patients who were anti-hyperglycaemic medication-na?ve or had discontinued metformin monotherapy [mean baseline HbA(1c) 59?±?8 to 61?±?8?mmol/mol (7.6?±?0.7 to 7.8?±?0.8%)] to once-weekly injections of placebo or dulaglutide (0.1, 0.5, 1.0 or 1.5?mg). Results A significant dose-dependent reduction in HbA(1c) (least squares mean?±?se) was observed across doses (P?相似文献   

10.
11.
12.
13.

Background:

Hemorrhage coupled with coagulopathy remains the leading cause of preventable in-hospital deaths among trauma patients. Use of a transfusion protocol with a predefined ratio of 1:1:1 (1 each of red blood cells [RBC], frozen plasma [FP] and platelets) has been associated with improved survival in retrospective studies in military and civilian settings, but such a protocol has its challenges and may increase the risk of respiratory complications. We conducted a randomized controlled trial to assess the feasibility of a 1:1:1 transfusion protocol and its effect on mortality and complications among patients with severe trauma.

Methods:

We included 78 patients seen in a tertiary trauma centre between July 2009 and October 2011 who had hypotension and bleeding and were expected to need massive transfusion (≥ 10 RBC units in 24 h). We randomly assigned them to either the fixed-ratio (1:1:1) transfusion protocol (n = 40) or to a laboratory-results–guided transfusion protocol (control; n = 38). The primary outcome, feasibility, was assessed in terms of blood product ratios and plasma wastage. Safety was measured based on 28-day mortality and survival free of acute respiratory distress syndrome.

Results:

Overall, a transfusion ratio of 1:1:1 was achieved in 57% (21/37) of patients in the fixed-ratio group, as compared with 6% (2/32) in the control group. A ratio of 1:1 (RBC:FP) was achieved in 73% (27/37) in the fixed-ratio group and 22% (7/32) in the control group. Plasma wastage was higher with the intervention protocol (22% [86/390] of FP units v. 10% [30/289] in the control group). The 28-day mortality and number of days free of acute respiratory distress syndrome were statistically similar between the groups.

Interpretation:

The fixed-ratio transfusion protocol was feasible in our study, but it was associated with increased plasma wastage. Larger randomized trials are needed to evaluate the efficacy of such a protocol in trauma care. Trial registration: ClinicalTrials.gov, no. NCT00945542A fixed-ratio (1:1:1) transfusion strategy is a resuscitation strategy for trauma patients that promotes the transfusion of red blood cells (RBC), plasma and platelets (PLT) at a 1:1:1 ratio while minimizing crystalloid infusion.1 This balanced transfusion strategy aims to correct both the early coagulopathy of trauma and the volume status of patients in hemorrhagic shock, thus targeting preventable hemorrhage-related deaths.2,3 Retrospective studies of the 1:1:1 transfusion protocol reported marked reductions in mortality based on retrospectively calculated ratios of plasma:PLT:RBC.46 Methodologic limitations, particularly survivorship bias (where higher mortality was associated with low ratios of plasma and PLT to RBC in unsalvageable patients who died before 1:1:1 transfusion could be achieved), preclude any definitive conclusion on the potential benefit of a 1:1:1 transfusion strategy in terms of efficacy and safety.710The 1:1:1 transfusion strategy has been widely adopted by trauma centres worldwide11,12 and is being increasingly used in prehospital care and in the care of patients without traumatic injuries.1315 Widespread adoption of the strategy has significant resource and safety implications. Its full implementation requires access to thawed type AB plasma, which is chronically in short supply.16 In addition, because of the difficulty in predicting the need for massive transfusion (commonly defined as ≥ 10 RBC units in 24 h), the 1:1:1 transfusion protocol may lead to unnecessary exposure to blood components and an increased risk of acute respiratory distress syndrome, sepsis and multiple organ dysfunction.17We conducted a pilot randomized controlled trial comparing a 1:1:1 transfusion strategy with the standard of care at our institution (laboratory-results–guided transfusion; laboratory results are available for transfusion decisions throughout resuscitation) in trauma patients predicted to need massive transfusion. Our primary objective was to assess the feasibility and safety of the fixed-ratio protocol in patients with severe trauma.  相似文献   

14.
Distress calls were recorded from three sympatric species of pipistrelle bat (Pipistrellus nathusii, P. pipistrellus and P. pygmaeus) in England and Northern Ireland. At foraging sites, we conducted playback experiments, consisting of experimental distress call sequences from each species and control sequences of random noise and sound recorded with no bats present. We measured response by simultaneously recording ultrasound during playbacks and counting the echolocation pulses above a predetermined threshold which were then identified to species. All three species responded to each other's calls. The number of recorded echolocation pulses of all species increased eight-fold, on average, during the playback of distress call sequences compared with the playback of ultrasonic noise, and four-fold compared with the playback of silence. In a separate playback experiment, the number of echolocation pulses of P. pygmaeus increased 14-fold during the playback of distress calls of four endemic species of bat from Madagascar (Emballonura atrata, Myotis goudoti, Miniopterus majori and M. manavi) compared with the playback of silence. This increased response might have been caused by the high calling rates of the Malagasy species. Distress calls of P. nathusii, P. pipistrellus and P. pygmaeus were structurally convergent, consisting of a series of downward-sweeping, frequency-modulated elements of short duration and high intensity with a relatively strong harmonic content. Selection may favour convergence in the structure of distress calls among bat species, if attracting heterospecifics increases the chance of repelling predators by mobbing.  相似文献   

15.
Molecular Biology Reports - Science is still unable to develop a specific strategy for predicting breast cancer in humans. Several attempts are done to obtain the best and closest prognostic...  相似文献   

16.

Background

Physical activity is believed to exert a beneficial effect on functional and cognitive rehabilitation of patients with stroke. Although studies have addressed the impact of physical exercise in cerebrovascular prevention and rehabilitation, the underlying mechanisms leading to improvement are poorly understood. Training-induced increase of cerebral perfusion is a possible mediating mechanism. Our exploratory study aims to investigate training-induced changes in blood biomarker levels and magnetic resonance imaging in patients with subacute ischemic stroke.

Methods/design

This biomarker-driven study uses an observational design to examine a subgroup of patients in the randomized, controlled PHYS-STROKE trial. In PHYS-STROKE, 215 patients with subacute stroke (hemorrhagic and ischemic) receive either 4 weeks of physical training (aerobic training, 5 times a week, for 50 minutes) or 4 weeks of relaxation sessions (5 times a week, for 50 minutes). A convenience sample of 100 of these patients with ischemic stroke will be included in BAPTISe and will receive magnetic resonance imaging (MRI) scans and an additional blood draw before and after the PHYS-STROKE intervention. Imaging scans will address parameters of cerebral perfusion, vessel size imaging, and microvessel density (the Q factor) to estimate the degree of neovascularization in the brain. Blood tests will determine several parameters of immunity, inflammation, endothelial function, and lipometabolism. Primary objective of this study is to evaluate differential changes in MRI and blood-derived biomarkers between groups. Other endpoints are next cerebrovascular events and functional status of the patient after the intervention and after 3 months assessed by functional scores, in particular walking speed and Barthel index (co-primary endpoints of PHYS-STROKE). Additionally, we will assess the association between functional outcomes and biomarkers including imaging results. For all endpoints we will compare changes between patients who received physical fitness training and patients who had relaxation sessions.

Discussion

This exploratory study will be the first to investigate the effects of physical fitness training in patients with ischemic stroke on MRI-based cerebral perfusion, pertinent blood biomarker levels, and functional outcome. The study may have an impact on current patient rehabilitation strategies and reveal important information about the roles of MRI and blood-derived biomarkers in ischemic stroke.

Trial registration

NCT01954797.
  相似文献   

17.
18.

Background

The high incidence of cardiovascular disease in patients with end stage renal disease (ESRD) is related to the accumulation of uremic toxins in the middle and large-middle molecular weight range. As online hemodiafiltration (HDF) removes these molecules more effectively than standard hemodialysis (HD), it has been suggested that online HDF improves survival and cardiovascular outcome. Thus far, no conclusive data of HDF on target organ damage and cardiovascular morbidity and mortality are available. Therefore, the CONvective TRAnsport STudy (CONTRAST) has been initiated.

Methods

CONTRAST is a Dutch multi-center randomised controlled trial. In this trial, approximately 800 chronic hemodialysis patients will be randomised between online HDF and low-flux HD, and followed for three years. The primary endpoint is all cause mortality. The main secondary outcome variables are fatal and non-fatal cardiovascular events.

Conclusion

The study is designed to provide conclusive evidence whether online HDF leads to a lower mortality and less cardiovascular events as compared to standard HD.  相似文献   

19.
It is well established that, upon changing their natural desert low caloric (succulent halophilic plants) to a regular laboratory high caloric diet, sand rats undergo various phenotypic changes depending on their genetic background and including obesity and various degrees of insulin resistance. Our aim was to investigate the acute effects of Interleukin-1β (IL-1β) and Interferon-γ (IFN-γ) on glucose-induced insulin secretion in normal lean sand rats maintained on their natural diet and in obese insulin resistant normoglycemic or type 2 diabetic animals after a 9-month high caloric diet. Animals were fed either a low or a high caloric diet; after 9 months, pancreatic islets were isolated and incubated in the presence of increasing cytokine concentrations. At the end of the high-energy diet, animals were all over-weight, and probably due to a different genetic background, they displayed either insulin resistance, hyperinsulinemia and normoglycemia or a marked type-2 diabetic state. Pancreatic islets from obese insulin resistant normoglycemic animals were much more sensitive and responsive to IL-1β when compared to lean controls. The cytokine was inefficient in diabetic islets. In conclusion, the markedly increased insulinotropic effect of IL-1β in obese diabetes-resistant sand rat could participate and be involved in pancreatic β-cell hyperactivity that compensates for insulin resistance and thereby prevent the development of type 2 diabetes in these animals.  相似文献   

20.

Background

Several single nucleotide polymorphisms (SNPs) in the X-ray cross-complementing group 1 (XRCC1) gene have been shown to influence DNA repair and to modify cancer susceptibility. To investigate the role of these loci further, we examined the association of three XRCC1 polymorphisms with the risk of gliomas in a Han population in northeastern China.

Methods

Using a PCR–RFLP method, XRCC1 Arg194Trp, Arg280His and Arg399Gln were genotyped in 624 glioma patients and 580 healthy controls.

Results

Significant differences in the distribution of the Arg399Gln allele were detected between glioma patients and healthy controls by a logistic regression analysis (OR = 1.35, 95%CI 1.17–1.68, P = 0.001). Our data also revealed that the Arg399Gln variant (allele A) carriers had an increased glioma risk compared to the wild-type (allele G) homozygous carriers (OR = 1.40, 95%CI 1.12–1.76, P = 0.003).

Conclusions

These results suggest that the XRCC1 Arg399Gln might influence the risk of developing glioma in a Han population in northeastern Chinese.  相似文献   

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