nils-herrmann/clean_scirepeval huggingface dataset:
Visual cue training to improve walking and turning after stroke: a study protocol for a multi-centre, single blind randomised pilot trial

Visual information comprises one of the most salient sources of information used to control walking and the dependence on vision to maintain dynamic stability increases following a stroke. We hypothesize, therefore, that rehabilitation efforts incorporating visual cues may be effective in triggering recovery and adaptability of gait following stroke. This feasibility trial aims to estimate probable recruitment rate, effect size, treatment adherence and response to gait training with visual cues in contrast to conventional overground walking practice following stroke.



A 3-arm, parallel group, multi-centre, single blind, randomised control feasibility trial will compare overground visual cue training (O-VCT), treadmill visual cue training (T-VCT), and usual care (UC). Participants (n = 60) will be randomly assigned to one of three treatments by a central randomisation centre using computer generated tables to allocate treatment groups. The research assessor will remain blind to allocation. Treatment, delivered by physiotherapists, will be twice weekly for 8 weeks at participating outpatient hospital sites for the O-VCT or UC and in a University setting for T-VCT participants.Individuals with gait impairment due to stroke, with restricted community ambulation (gait speed <0.8m/s), residual lower limb paresis and who are able to take part in repetitive walking practice involving visual cues (i.e., no severe visual impairments, able to walk with minimal assistance and no comorbid medical contraindications for walking practice) will be included.The primary outcomes concerning participant enrolment, recruitment, retention, and health and social care resource use data will be recorded over a recruitment period of 18 months. Secondary outcome measures will be undertaken before randomisation (baseline), after the eight-week intervention (outcome), and at three months (follow-up). Outcome measures will include gait speed and step length symmetry; time and steps taken to complete a 180° turn; assessment of gait adaptability (success rate in target stepping); timed up and go; Fugl-Meyer lower limb motor assessment; Berg balance scale; falls efficacy scale; SF-12; and functional ambulation category.



Participation and compliance measured by treatment logs, accrual rate, attrition, and response variation will determine sample sizes for an early phase randomised controlled trial and indicate whether a definitive late phase efficacy trial is justified.
Intensive care unit prognostic factors in critically ill patients with advanced solid tumors: a 3-year retrospective study

The objective of this study was to identify risk factors predicting prognosis of critically ill medical patients with advanced solid tumors in the intensive care unit (ICU). We retrospectively analyzed all ICU unplanned medical admissions to the ICU of patients with advanced solid cancer in Tianjin Medical University Cancer Institute and Hospital between October 1, 2012 and March 1, 2015. Approval was obtained from the Ethical Commission of Tianjin Medical University Cancer Institute and Hospital to review and publish information from patients’ records. One hundred and forty-one patients with full code status met the criteria for inclusion from among 813 ICU admissions. ICU mortality was 14.9 % and in-hospital mortality was 29.8 %. The major reasons for unplanned ICU admission were respiratory failure (38.3 %) and severe sepsis or septic shock (27.7 %). The ICU mortality in patients who required vasopressors, mechanical ventilation or renal replacement therapy for >24 h was 25, 25.9 and 40 %, respectively. The mean overall survival was 28.6 months. After adjusting for hypertension, type of solid cancer, intervention time, need for mechanical ventilation and Acute Physiology and Chronic Health Evaluation II score, only Sepsis-related Organ Failure Assessment (SOFA) score on day 7 of ICU treatment remained a significant predictor of ICU mortality (adjusted odds ratio 1.612, 95 % confidence interval 1.137–2.285, P = 0.007). We suggest broadening the criteria for ICU admission. The patients should be allowed an ICU trial consisting of unlimited ICU support, including invasive hemodynamic monitoring, mechanical ventilation and renal replacement therapy. An interdisciplinary meeting, including an ethics consultation, should be held to make end-of-life decisions if the SOFA score on day 7 shows clinical deterioration with no available therapeutic options.
Does pre-treatment with aspirin and loading dose clopidogrel obviate the need for glycoprotein IIb/IIIa antagonists during elective coronary stenting? A focus on peri-procedural myonecrosis.

Although full platelet inhibition with aspirin and thienopyridines before coronary stenting has significantly reduced the risk of acute stent thrombosis, peri-procedural myonecrosis still occurs frequently and is associated with increased death rate. Whether further inhibition of platelet aggregation by a glycoprotein IIb/IIIa antagonist may provide an additional cardioprotection is unknown.



A total of 200 patients pre-treated with aspirin and a loading dose of clopidogrel (450 mg) were randomized just before coronary intervention (percutaneous coronary intervention, PCI) to treatment with or without abciximab. Platelet aggregation was assessed in samples collected during the procedure and the degree of platelet aggregation inhibition was correlated with cardiac enzyme release post-PCI. Abciximab treatment achieved a more complete inhibition of aggregation than dual oral antiplatelet therapy alone (median value of 1 vs. 50%, normal 100%). Any pathological increase in creatinine kinase-MB (CK-MB) post-PCI was present in 21% of the abciximab group and in 22% of the no-abciximab group (P = 0.9). Also the occurrence of clinically relevant myonecrosis [myocardial infarction (MI) = CK-MB > 3x upper limit of normal] was not significantly influenced by treatment assignment: 9 vs. 10% (P = 0.9). In a multiple logistic regression model including clinical, angiographic, and procedural characteristics, post-PCI myonecrosis was not correlated with the degree of platelet aggregation inhibition but with procedural features (such as long inflation time) and with the presence of multi-vessel disease. There were no cases of acute or subacute stent thrombosis. At 6 months, major adverse cardiac events, including cardiac death, non-fatal MI, or target lesion revascularization occurred in 13% of abciximab patients and in 16% of the control patients (P = 0.6).



In the studied patients scheduled for elective coronary stenting and pre-treated with aspirin and a loading dose of clopidogrel, further inhibition of platelet aggregation by abciximab does not afford additional cardioprotection. Our data suggest that distal athero-embolization rather than thrombo-embolization is involved in the phenomenon of myonecrosis post-elective stenting.
Vijana Vijiweni II: a cluster-randomized trial to evaluate the efficacy of a microfinance and peer health leadership intervention for HIV and intimate partner violence prevention among social networks of young men in Dar es Salaam

Intimate partner violence (IPV) and sexually transmitted infections (STIs), including HIV, remain important public health problems with devastating health effects for men and women in sub-Saharan Africa. There have been calls to engage men in prevention efforts, however, we lack effective approaches to reach and engage them. Social network approaches have demonstrated effective and sustained outcomes on changing risk behaviors in the U.S. Our team has identified and engaged naturally occurring social networks comprised mostly of young men in Dar es Salaam in an intervention designed to jointly reduce STI incidence and the perpetration of IPV. These stable networks are locally referred to as "camps." In a pilot study we demonstrated the feasibility and acceptability of a combined microfinance and peer health leadership intervention within these camp-based peer networks.



We are implementing a cluster-randomized trial to evaluate the efficacy of an intervention combining microfinance with health leadership training in 60 camps in Dar es Salaam, Tanzania. Half of the camps have been randomized to the intervention arm, and half to a control arm. The camps in the intervention arm will receive a combined microfinance and health leadership intervention for a period of two years. The camps in the control arm will receive a delayed intervention. We have enrolled 1,258 men across the 60 study camps. Behavioral surveys will be conducted at baseline, 12-months post intervention launch and 30-month post intervention launch and biological samples will be drawn to test for Neisseria gonorrhea (NG), Chlamydia trachomatis (CT), and Trichomonas vaginalis (TV) at baseline and 30-months. The primary endpoints for assessing intervention impact are IPV perpetration and STI incidence.



This is the first cluster-randomized trial targeting social networks of men in sub-Saharan Africa that jointly addresses HIV and IPV perpetration and has both biological and behavioral endpoints. Effective approaches to engage men in HIV and IPV prevention are needed in low resource, high prevalence settings like Tanzania. If we determine that this approach is effective, we will examine how to adapt and scale up this approach to other urban, sub-Saharan African settings.
Is sense of coherence a predictor of lifestyle changes in subjects at risk for type 2 diabetes?

To determine whether the sense of coherence (SOC) could predict the outcome of an 18-month lifestyle intervention program for subjects at risk of type 2 diabetes.



Subjects at high risk of type 2 diabetes mellitus were recruited to a low-intensity lifestyle intervention program by their general practitioners. Weight reduction ≥ 5% and improvement in exercise capacity of ≥ 10% from baseline to follow-up indicated a clinically significant lifestyle change. SOC was measured using the 13-item SOC questionnaire.



The study involved 213 subjects with a mean body mass index of 37 (SD ± 6). Complete follow-up data were obtained for 131 (62%). Twenty-six participants had clinically significant lifestyle changes. There was a 21% increase in the odds of a clinically significant lifestyle change for each point increase in the baseline SOC score (odds ratio = 1.21; confidence interval = 1.11-1.32). The success rate was 14 times higher in the highest SOC score tertile group compared with the lowest.



High SOC scores were good predictors of successful lifestyle change in subjects at risk of type 2 diabetes. SOC-13 can be used in daily practice to increase clinical awareness on the impact of mastery on the outcome of life-style intervention programs.
The Japan Environment and Children’s Study (JECS): A Preliminary Report on Selected Characteristics of Approximately 10 000 Pregnant Women Recruited During the First Year of the Study

The Japan Environment and Children's Study (JECS) is an ongoing nationwide birth cohort study launched in January 2011. In this progress report, we present data collected in the first year to summarize selected maternal and infant characteristics.



In the 15 Regional Centers located throughout Japan, the expectant mothers were recruited in early pregnancy at obstetric facilities and/or at local government offices issuing pregnancy journals. Self-administered questionnaires were distributed to the women during their first trimester and then again during the second or third trimester to obtain information on demographic factors, physical and mental health, lifestyle, occupation, environmental exposure, dwelling conditions, and socioeconomic status. Information was obtained from medical records in the first trimester and after delivery on medical history, including gravidity and related complications, parity, maternal anthropometry, and infant physical examinations.



We collected data on a total of 9819 expectant mothers (mean age = 31.0 years) who gave birth during 2011. There were 9635 live births. The selected infant characteristics (singleton births, gestational age at birth, sex, birth weight) in the JECS population were similar to those in national survey data on the Japanese general population.



Our final birth data will eventually be used to evaluate the national representativeness of the JECS population. We hope the JECS will provide valuable information on the impact of the environment in which our children live on their health and development.
Effectiveness of a theory-based intervention to increase colorectal cancer screening among Iranian health club members: a randomized trial

Colorectal cancer is the third most commonly diagnosed cancer and the fourth leading cause of death in the world. There are few published studies that have used theory-based interventions designed to increase colorectal cancer screening in community lay health organizations. The present study was guided by the theoretical concepts of the preventive health model. Twelve health clubs of a municipal district in Tehran were randomized to two study groups with equal ratio. The control group received usual services throughout the study while the intervention group also received a theory-based educational program on colorectal cancer screening plus a reminder call. Screening behavior, the main outcome, was assessed 4 months after randomization. A total of 360 members aged 50 and older from 12 health clubs completed a baseline survey. Participants in the intervention group reported increased knowledge of colorectal cancer and screening tests at 4 months follow-up (p’s < .001). Moreover, exposure to the theory-based intervention significantly improved self-efficacy, perceived susceptibility, efficacy of screening, social support, and intention to be screened for colorectal cancer, from baseline to 4 months follow-up (p’s < .001). The screening rate for colorectal cancer was significantly higher in the intervention group compared to the control group (odds ratio = 15.93, 95 % CI = 5.57, 45.53). Our theory-based intervention was found to have a significant effect on colorectal cancer screening use as measured by self-report. The findings could have implications for colorectal cancer screening program development and implementation in primary health care settings and through other community organizations.
Bortezomib, melphalan, prednisone, and thalidomide for relapsed multiple myeloma.

In multiple myeloma (MM), the addition of thalidomide or bortezomib to the standard oral melphalan/prednisone combination significantly increased response rate and event-free survival. In this multicenter phase 1/2 trial, dosing, safety, and efficacy of the 4-drug combination, bortezomib, melphalan, prednisone, and thalidomide (VMPT) was determined. Bortezomib was administered at 3 dose levels (1.0 mg/m2, 1.3 mg/m2, or 1.6 mg/m2) on days 1, 4, 15, and 22; melphalan was given at a dose of 6 mg/m2 on days 1 through 5 and prednisone at 60 mg/m2 on days 1 through 5. Thalidomide was delivered at 50 mg on days 1 through 35. Each course was repeated every 35 days. The maximum tolerated dose of bortezomib was 1.3 mg/m2. Thirty patients with relapsed or refractory MM were enrolled; 20 patients (67%) achieved a partial response (PR) including 13 patients (43%) who achieved at least a very good PR. Among 14 patients who received VMPT as second-line treatment, the PR rate was 79% and the immunofixation-negative complete response rate 36%. The 1-year progression-free survival was 61%, and the 1-year survival from study entry was 84%. Grade 3 nonhematologic adverse events included infections (5 patients), fatigue (1), vasculitis (1), and peripheral neuropathy (2); no grade 4 toxicities were recorded. Initial results showed that VMPT is an effective salvage therapy with a very high proportion of responses. The incidence of neurotoxicities was unexpectedly low.
Addressing regional disparities in pediatric oncology: Results of a collaborative initiative across the Mexican-North American border.

Cancer is emerging as a major cause of childhood mortality in low- and middle-income countries. In Mexico, cancer is the number one cause of death in children aged 5-14. Until recently, many children with cancer from Baja California, Mexico, went untreated. We reasoned that an initiative inspired by the St. Jude Children's Research Hospital (SJCRH) "twinning" model could successfully be applied to the San Diego-Tijuana border region. In 2008, a twinning project was initiated by Rady Children's Hospital, SJCRH, and the General Hospital Tijuana (GHT). Our aim was to establish a pediatric oncology unit in a culturally sensitive manner, adapted to the local healthcare system.


PROCEDURE
An initial assessment revealed that despite existence of basic hospital infrastructure at the GHT, the essential elements of a pediatric cancer unit were lacking, including dedicated space, trained staff, and uniform treatment. A 5-year action plan was designed to offer training, support the staff financially, and improve the infrastructure.



After 7 years, accomplishments include the opening of a new inpatient unit with updated technology, fully trained staff, and a dedicated, interdisciplinary team. Over 700 children have benefited from accurate diagnosis and treatment.



Initiatives that implement long-term partnerships between institutions along the Mexican-North American border can be highly effective in establishing successful pediatric cancer control programs. The geographic proximity facilitated accelerated training and close monitoring of project development. Similar initiatives across other disciplines may benefit additional patients and synergize with pediatric oncology programs to reduce health disparities in underserved areas.
Hospital Variation in Functional Recovery After Stroke.

Functional status is a key patient-centric outcome, but there are little data on whether functional recovery post-stroke varies among hospitals. This study examined the distribution of functional status 3 months after stroke, determined whether these outcomes vary among hospitals, and identified hospital characteristics associated with better (or worse) functional outcomes.



Observational analysis of the AVAIL study (Adherence Evaluation After Ischemic Stroke-Longitudinal) included 2083 ischemic stroke patients enrolled from 82 US hospitals participating in Get With The Guidelines-Stroke and AVAIL. The primary outcome was dependence or death at 3 months (modified Rankin Scale [mRS] score of 3-6). Secondary outcomes included functional dependence (mRS score of 3-5), disabled (mRS score of 2-5), and mRS evaluated as a continuous score. By 3 months post-discharge, 36.5% of patients were functionally dependent or dead. Rates of dependence or death varied widely by discharging hospitals (range: 0%-67%). After risk adjustment, patients had lower rates of 3-month dependence or death when treated at teaching hospitals (odds ratio, 0.72; 95% confidence interval, 0.54-0.96) and certified primary stroke centers (odds ratio, 0.69; 95% confidence interval, 0.53-0.91). In contrast, a composite measure of hospital-level adherence to acute stroke care performance metrics, stroke volume, and bed size was not associated with downstream patient functional status. Findings were robust across mRS end points and sensitivity analyses.



One third of acute ischemic stroke patients were functionally dependent or dead 3 months postacute stroke; functional recovery rates varied considerably among hospitals, supporting the need to better determine which care processes can maximize functional outcomes.
Epidemiological and clinical characteristics and behaviours of individuals with newly diagnosed HIV infection: a multicentre study in north Italy.

We aimed to investigate socio-demographic, clinical and epidemiological characteristics and behaviours of subjects with new HIV diagnosis.



We carried out a multi-centre cross-sectional study comprising 17 infectious diseases units in the Lombardy Region, North Italy. All subjects with a first positive test for HIV infection examined in 2008-09 were interviewed using a structured questionnaire.



472 patients were enrolled (mean age 39.8 years, standard deviation [SD] 11.5), mostly males (78%), and born in Italy (77%). The most common routes of HIV transmission were heterosexual intercourse (49%) and sex among men who have sex with men (MSM) (40%). Never/sometimes use of a condom with occasional partners was associated with male gender, heterosexual transmission route, and with >10 sexual partners in their lifetime. 47% had previous HIV negative tests. Having had more than 2 previous HIV negative tests was associated with younger age, MSM transmission route, CD4+ lymphocyte count >350/microl and self-perception of risk.



This study shows that there is a large portion of the adult population, especially heterosexual men aged 45 years and over, who are at high risk of acquiring and transmitting HIV infection and undergoing the HIV diagnostic test late, due to risk behaviours combined with a low perception of being at risk. Compared to people infected by heterosexual contacts, MSM show a greater awareness of being at risk of infection, but this knowledge has a low impact in reducing at-risk behaviours.
Reliability, validity and normative data for the Danish Beck Youth Inventories.

This study examines reliability and validity and establish Danish norms for the Danish version of the Beck Youth Inventories (BYI) (Beck, Beck & Jolly, 2001), which consists of five self-report scales; Self-Concept (BSCI), Anxiety (BAI), Depression (BDI), Anger (BANI) and Disruptive Behavior (BDBI). A total of 1,116 school children and 128 clinical children, aged 7-14, completed BYI. Internal consistency coefficients were high. Most test-retest correlations were >0.70. A test-retest difference was found for BAI. Exploratory and confirmatory factor analysis indicated that the five factor structure of the instrument was justified. The BSCI, BAI and BDI discriminated moderately between the norming sample and the clinical group, and the latter group included more children who exceeded the 90th percentile of the norming sample. Diagnostic groups scored higher on relevant scales than norms. Only BSCI and BDI differentiated between diagnostic groups. The BYI showed acceptable internal consistency and test-retest stability, except for BAI. The BYI did not adequately differentiate between internalizing disorders.