nils-herrmann/clean_scirepeval huggingface dataset:
Study protocol of the YOU CALL - WE CALL TRIAL: impact of a multimodal support intervention after a "mild" stroke

More than 60% of new strokes each year are "mild" in severity and this proportion is expected to rise in the years to come. Within our current health care system those with "mild" stroke are typically discharged home within days, without further referral to health or rehabilitation services other than advice to see their family physician. Those with mild stroke often have limited access to support from health professionals with stroke-specific knowledge who would typically provide critical information on topics such as secondary stroke prevention, community reintegration, medication counselling and problem solving with regard to specific concerns that arise. Isolation and lack of knowledge may lead to a worsening of health problems including stroke recurrence and unnecessary and costly health care utilization.The purpose of this study is to assess the effectiveness, for individuals who experience a first "mild" stroke, of a sustainable, low cost, multimodal support intervention (comprising information, education and telephone support)--"WE CALL" compared to a passive intervention (providing the name and phone number of a resource person available if they feel the need to)--"YOU CALL", on two primary outcomes: unplanned-use of health services for negative events and quality of life.



We will recruit 384 adults who meet inclusion criteria for a first mild stroke across six Canadian sites. Baseline measures will be taken within the first month after stroke onset. Participants will be stratified according to comorbidity level and randomised to one of two groups: YOU CALL or WE CALL. Both interventions will be offered over a six months period. Primary outcomes include unplanned use of heath services for negative event (frequency calendar) and quality of life (EQ-5D and Quality of Life Index). Secondary outcomes include participation level (LIFE-H), depression (Beck Depression Inventory II) and use of health services for health promotion or prevention (frequency calendar). Blind assessors will gather data at mid-intervention, end of intervention and one year follow up.



If effective, this multimodal intervention could be delivered in both urban and rural environments. For example, existing infrastructure such as regional stroke centers and existing secondary stroke prevention clinics, make this intervention, if effective, deliverable and sustainable.
Internally and externally guided voluntary saccades in unmedicated and medicated schizophrenic patients. Part II. Saccadic latency, gain, and fixation suppression errors

Saccades were elicited in 30 schizophrenic patients before medication, in 17 of them during medication with neuroleptics, and in 12 healthy controls using six paradigms that tested different types of saccades: (a) the externally triggered and visually guided saccades; (b) the externally triggered and internally guided saccades (anti-saccades); and (c) the internally triggered and internally guided saccades (memory-guided saccades). Latency of the primary saccade, gain (eye amplitude to target amplitude), and percentage of unwanted saccades (fixation suppression errors) were calculated. The externally triggered and externally guided saccades were only slightly affected in the patients, indicating that the function of parieto-tectal pathways was preserved. In contrast, the internally guided and externally triggered saccades showed abnormally long latencies, slightly smaller gains, and an increased rate of suppression errors regardless of the medication status. These findings were even more pronounced in the internally triggered and internally guided saccades such as memory-guided saccades. According to animal experiments and studies on patients with disorders of the basal ganglia, the performance of these saccades is based on the function of the pre- and dorsolateral frontal cortex and its connections to the basal ganglia. The minimal improvement of some of the parameters after clinical improvement and during treatment with neuroleptics suggests that the eye-movement deficits are associated with abnormalities of schizophrenia, which do not basically change under medication with neuroleptics. The observed effects of neuroleptics also argue against a primary abnormality in the dopaminergic input to the frontal cortex – basal ganglia oculomotor loop and support the view that there is a primary disturbance of the cortical input to the oculomotor loop through the basal ganglia in schizophrenics.
Reliability and validity of a tool to measure the severity of tongue thrust in children: the Tongue Thrust Rating Scale.

This study aimed to develop a scale called Tongue Thrust Rating Scale (TTRS), which categorised tongue thrust in children in terms of its severity during swallowing, and to investigate its validity and reliability. The study describes the developmental phase of the TTRS and presented its content and criterion-based validity and interobserver and intra-observer reliability. For content validation, seven experts assessed the steps in the scale over two Delphi rounds. Two physical therapists evaluated videos of 50 children with cerebral palsy (mean age, 57·9 ± 16·8 months), using the TTRS to test criterion-based validity, interobserver and intra-observer reliability. The Karaduman Chewing Performance Scale (KCPS) and Drooling Severity and Frequency Scale (DSFS) were used for criterion-based validity. All the TTRS steps were deemed necessary. The content validity index was 0·857. A very strong positive correlation was found between two examinations by one physical therapist, which indicated intra-observer reliability (r = 0·938, P < 0·001). A very strong positive correlation was also found between the TTRS scores of two physical therapists, indicating interobserver reliability (r = 0·892, P < 0·001). There was also a strong positive correlation between the TTRS and KCPS (r = 0·724, P < 0·001) and a very strong positive correlation between the TTRS scores and DSFS (r = 0·822 and r = 0·755; P < 0·001). These results demonstrated the criterion-based validity of the TTRS. The TTRS is a valid, reliable and clinically easy-to-use functional instrument to document the severity of tongue thrust in children.
Effect of Electrode Configuration and Capacitor Size on Internal Atrial Defibrillation Threshold Using Leads Currently Used for Ventricular Defibrillation.

Previous studies have shown that endocardial atrial defibrillation, using lead configurations specifically designed for ventricular defibrillation, is feasible but the substantial patient discomfort might prevent the widespread use of the technique unless significant improvements in shock tolerability are achieved. It has been suggested that the peak voltage or the peak current but not the total energy delivered determines the patient pain perception and therefore, lower defibrillating voltage and current achieved with modifications in lead and waveforms may increase shock tolerability. This study was undertaken to evaluate the effect, on the atrial defibrillation threshold (ADFT), of the addition of a patch electrode (mimicking the can electrode) to the right ventricle (RV)-superior vena cava (SVC) lead configuration. The influence of capacitor size on ADFT using the RV-SVC+skin patch configuration was also assessed.  In 10 patients (pts) (Group 1) cardioversion thresholds were evaluated using biphasic shocks in two different configurations: 1) right ventricle (RV) to superior vena cava (SVC); 2) RV to SVC+skin patch. In a second group of twelve patients (Group 2) atrial defibrillation thresholds of biphasic waveforms that differed with the total capacitance (90 or 170 µF) were assessed using the RV to SVC+skin patch configuration.  In Group 1 AF was terminated in 10/10 pts (100 %) with both configurations. There was no significant difference in delivered energy at the defibrillation threshold between the two configurations (7.1 ± 5.1 J vs 7.1 ± 2.6 J; p < 0.05). In group 2 AF was terminated in 12/12 pts (100%) with both waveforms. The 170 µF waveform provided a significantly lower defibrillating voltage (323.7 ± 74.6 V vs 380 ± 70.2 V; p < 0.03) and current (8.1 ± 2.7 A vs 10.0 ± 2.3 A; p < 0.04) than the 90 µF waveform. All pts, in both groups, perceived the shock of the lowest energy tested (180 V) as painful or uncomfortable.  The addition of a patch electrode to the RV-SVC lead configuration does not reduce the ADFT. Shocks from larger capacitors defibrillate with lower voltage and current but pts still perceive low energy subthreshold shocks as painful or uncomfortable.
Characteristics and Outcome of Patients Diagnosed With HIV at Older Age

To characterize the clinical, virological, and immunological status at presentation as well as the outcome of patients diagnosed with HIV above the age of 50. A retrospective study of 418 patients newly diagnosed with HIV in 1 Israeli center, between the years 2004 and 2013. Patients with new HIV diagnosis ≥ 50 years of age defined as "older' and < 50 defined as "younger.' Patients were evaluated every 1 to 3 months (mean follow-up 53 ± 33 months). Patients with < 2 CD4/viral-load measurements or with < 1 year of follow-up were excluded. Time of HIV infection was estimated by HIV sequence ambiguity assay. Ambiguity index ≤ 0.43 indicated recent (≤ 1 year) HIV infection. Eighty nine (21%) patients were diagnosed with HIV at an older age. Those older patients presented with significant lower CD4 cell counts and higher viral-load compared with the younger patients. At the end of the study, the older patients had higher mortality rate (21% vs 3.5%; P < 0.001) and lower CD4 cell counts (381 ± 228 vs 483 ± 26 cells/μL; P < 0.001) compared with the younger patients. This difference was also observed between older and younger patients with similar CD4 cell counts and viral load at the time of HIV diagnosis and among patients with a recent (≤ 1 year) HIV infection. One-fifth of HIV patients are diagnosed at older age (≥ 50 years). Those older patients have less favorable outcome compared with the younger patients. This point to the need of educational and screening programs within older populations and for a closer follow-up of older HIV patients.
Bronchodilator response to albuterol after regular formoterol and effects of acute corticosteroid administration.

There is controversy about the development of bronchodilator subsensitivity after regular administration of long-acting beta(2)-agonists.



The purpose of the study was to evaluate whether regular treatment with formoterol affects the bronchodilator response to repeated puffs of albuterol, and also to assess the effects of acute administration of a bolus dose of IV or inhaled corticosteroid.



Twelve patients (mean [SD] age, 43  years; FEV(1), 57 [17] % predicted) with stable, moderate to severe persistent asthma who were all taking inhaled corticosteroids were evaluated in a randomized, placebo-controlled, double-blind, double-dummy, crossover study. Patients received treatments each for 2 weeks followed by a bolus (IV/inhaled) of corticosteroid or placebo: (1) placebo inhaler bid + bolus placebo; (2) formoterol Turbuhaler 24 microg metered dosage bid (delivered dosage 18 microg bid) + placebo; (3) formoterol 24 microg bid + bolus IV hydrocortisone, 200 mg; or (4) formoterol 24 microg bid + bolus inhaled budesonide, 1,600 microg. Bronchodilator response to repeated puffs of albuterol (200 to 1,600 microg) for > 80 min was measured at 2 h after bolus administration of placebo or corticosteroid. The study was powered at the 80% level to detect a 20% difference in area under curve between 20 and 80 min (AUC) for FEV(1) response to albuterol as change from baseline (primary end point).



There was significant subsensitivity (p = 0.01) of the mean albuterol FEV(1) response (as AUC, L x s) after formoterol alone (737) as compared to placebo (1,453) along with partial reversal by steroid administration: formoterol + hydrocortisone (1, 050), and formoterol + budesonide (942). There was a similar pattern of subsensitivity (p = 0.03) for the mean albuterol forced expiratory flow between 25% and 75% of vital capacity response (as AUC, L): placebo (2,149), formoterol alone (1,002), formoterol + hydrocortisone (1,402), and formoterol + budesonide (1,271).



Regular treatment with formoterol produced significant bronchodilator subsensitivity to repeated puffs of albuterol, which was partially reversed by a bolus dose of systemic or inhaled corticosteroid.
Basal and T₃-induced ROS production in lymphocyte mitochondria is increased in type 2 diabetic patients.

Mitochondrial function, including production of reactive oxygen species (ROS), is important in the pathogenesis of diabetes and its complications. Thyroid hormones are major regulator of these processes. Hence, the aim of this study was to examine the thyroid hormone regulation of ROS production in human lymphocytes in patients with diabetes mellitus type 2 (T2DM). Lymphocytes from 10 controls and 10 persons with T2DM were examined. Mitochondrial membrane potential (MMP) was examined by flow cytometry after staining with MitoTracker Green (MTG). Similarly ROS was measured following staining with carboxy-H₂DCFDA. MMP was increased in T2DM patients and T₃ stimulation increased MMP in controls [1398 a.u. (979-4094) vs. 2156 a.u. (1611-15189), p=0.04, median and quartiles] as well as in T2DM patients [9167 a.u. (7387-11746) vs. 20274 a.u. (17183-27839 p=0.004, median and quartiles]. Basal ROS concentration was increased in lymphocytes from T2DM and T₃ significantly stimulated ROS concentration in controls [3691 a.u. (2584-6396) vs. 5650 a.u. (3001-7802) p=0.013, median and quartiles] and in T2DM patients [19271 a.u. (6288-25282) vs. 23178 a.u. (10004-28857) p=0.013, median and quartiles]. The ratio of ROS production related to MMP was significantly higher in T2DM, unstimulated as well as T₃-stimulated in T2DM. Unstimulated and T₃ stimulated ROS production and MMP were higher in lymphocytes from diabetic patients. An altered balance between ROS production and MMP, favoring ROS production in T2DM patients, was found suggesting that an increased mitochondrial sensitivity for T₃ may be a significant factor responsible for increased ROS activity in diabetic patients.
Osteoporosis Assessment Questionnaire-Physical Function (OPAQ-PF): a psychometrically validated osteoporosis-targeted patient reported outcome measure of daily activities of physical function

The purpose of this study was to evaluate the measurement properties of the Osteoporosis Assessment Questionnaire-Physical Functioning (OPAQ-PF). Based on this study, the OPAQ-PF has confirmed unidimensionality and acceptable reliability, construct validity, and sensitivity to change in a recent fracture/no recent fracture osteoporosis sample. Dimensionality was established through exploratory and confirmatory factor analysis. Patients completed three patient reported outcome (PRO) measures and four performance-based measures (PBMs) at baseline to enable an evaluation of construct validity. Patients without a recent fracture completed the OPAQ-PF 2 weeks after baseline to enable an evaluation of test–retest reliability. Ability to detect change and interpretation of change were investigated following completion of the OPAQ-PF 12 and 24 weeks postbaseline by patients with a recent fracture. A prospective psychometric validation study in 144 postmenopausal women, with moderate to severe osteoporosis, 37 of whom had experienced a recent fragility fracture (<6 weeks). Unidimensionality was established for the OPAQ-PF by factor analysis. The OPAQ-PF had good internal consistency (α = 0.974) and test–retest reliability (mean intraclass correlation coefficient (ICC) 0.993. The OPAQ-PF differentiated between patients with/without recent fracture, and by severity of osteoarthritis; it correlated strongly with hypothesized-related scales and PBMs (r > 0.3, p < 0.001). Ability to detect change was established with high correlations between changes in OPAQ-PF score and changes in global concept scores in recent fracture patients (r ≥ 0.6, 24-week change). Effect size of change on OPAQ-PF score increased by level of global change (p < 0.001). Anchor-based methods identified an OPAQ-PF change of 10 at an individual patient level and 20 at a group level as meaningful to patients. The OPAQ-PF has confirmed unidimensionality and acceptable reliability, construct validity, and sensitivity to change in a recent fracture/no recent fracture osteoporosis sample.
High stability of blood samples for flow cytometric analysis of VASP phosphorylation to measure the clopidogrel responsiveness in patients with coronary artery disease.

cation of twenty-one new mutations in the factor IX gene by SSCP analysis.  Mutat 1999; 13: 160–5. 8. Herbert O, Trossaert M, Boisseau P et al. Evaluation of denaturing high-performance liquid chromatography (DHPLC) in the screening of mutations in haemophilia B patients.  Haemost 2004; 2: 2267–9. 9. Haemophilia B Mutation database: (Version 13, 2004): http://www.kcl.ac.uk/ip/petergreen/haemBda tabase.html/. A database of point mutations and short additions and deletions in the factor IX gene. 10. Jayandharan G, Shaji RV, Nair SC et al. Novel missense mutations in two patients with factor XI deficiency (Val271Leu and Tyr351Ser) and one patient with combined factor XI and factor IX deficiency (Phe349Val).  Haemost 2005; 3: 808–11. 11. Bottema CDK, Ketterling RP, Li S et al. Missense mutations and evolutionary conservation of amino acids: evidence that many of the amino acids in factor IX function as “spacer” elements. Am J Hum Genet 1991; 49: 820–38. 12. Larson PJ, Stanfield-Oakley SA, VanDusen WJ et al. Structural integrity of the gamma-carboxyglutamic acid domain of human blood coagulation factor IXa is required for its binding to cofactor VIIIa.  3869–76. 13. Aktimur A, Gabriel MA, Gailani D et al. The factor IX gamma-carboxyglutamic acid (Gla) domain is involved in interactions between factor IX and factor XIa.  Enjolras N, Plantier JL, Rodriguez MH et al. Two novel mutations in EGF-like domains of human factor IX dramatically impair intracellular processing and secretion.  Haemost 2004; 2: 1143–54. 15. Bajaj S. Region of factor IXa protease domain that interacts with factor VIIIa: Analysis of select haemophilia B mutants. Thromb Haemost 1999; 82: 218–25. 16. Yoshitake S, Schach BG, Foster DC et al. Nucleotide sequence of the gene for human factor IX (antihemophilic factor B). Biochemistry 1985; 24: 3736–50. Letters
Effect of memantine combination therapy on symptoms in patients with moderate-to-severe depressive disorder: randomized, double-blind, placebo-controlled study.

Current treatments for depressive disorders are far from optimum. This study was planned to evaluate possible antidepressant effects and safety of memantine, a selective N-methyl-d-aspartate receptor antagonist, in humans.



Sixty-six outpatients with the diagnosis of moderate-to-severe major depressive disorder, based on DSM-V diagnostic criteria, were recruited to participate in a parallel, randomized, controlled trial. Sixty-two participants completed 6 weeks of treatment with either memantine (20 mg/day) plus sertraline (200 mg/day) or placebo plus sertraline (200 mg/day). Patients were evaluated using the Hamilton Depression Rating Scale (HDRS) at baseline and at weeks 2, 4 and 6. Comparison of treatment efficacy in improving depressive symptoms between the two groups was the principal outcome measure.



A repeated-measures analysis demonstrated significant time × treatment interaction on HDRS score [F (2·09, 125·67) = 5·09, P = 0·007]. Significantly greater improvement was seen at all three follow-up sessions as well as significantly greater response rates at weeks 4 and 6 (P = 0·018 and P < 0·001, respectively) in the memantine group. Significantly more early improvers and more rapid response to treatment were observed in the memantine group (P = 0·001 and P < 0·001, respectively). A significant reduction was observed in HDRS score from baseline to the study endpoint in both memantine (P < 0·001, Cohen's d = 12·71) and placebo groups (P < 0·001, Cohen's d = 5·13). No serious adverse event occurred. No significantly greater remission rate was seen in the adjunctive memantine therapy.



A 6-week course of treatment with memantine as adjunct to sertraline showed a favourable safety and efficacy profile in patients with major depressive disorder. Nonetheless, larger controlled studies of longer duration are necessary to assess long-term safety, efficacy and optimal dosing.
Phase I dose-escalation study of the thioxanthone SR271425 administered intravenously once every 3 weeks in patients with advanced malignancies

This study was performed to determine the dose limiting toxicity (DLT), the recommended phase II dose and the pharmacokinetic profile for SR271425, given over 1 h every 3 weeks. The initial starting dose of SR271425 was 17 mg/m2. Patient selection was based on common phase I criteria as well as additional cardiac criteria. Thirty-eight patients were accrued to 16 dose levels from 17 to 1,320 mg/m2. Patient characteristics included 24 males and 14 females ages 35–78 with an Eastern Cooperative Oncology Group performance status of 0 (ten patients), 1 (27) and 2 (1). Tumor types were typical for a phase I study. The maximum administered dose was 1,320 mg/m2 with two DLTs, both QTc grade 3 prolongation. No drug related hematological toxicity was noted. Grade 1 toxicities included rash, flushing, pruritus, weight loss, diarrhea, hypertension and fatigue. Grade 2 toxicities included yellow discoloration of the skin, nausea and vomiting. QTc prolongation and hyperbilirubinemia were the only grade 3 toxicities noted. No confirmed tumor response was observed; however, two patients had prolonged stable disease. Both Cend and area under the plasma concentration–time curve increased in a dose related manner. Plasma drug concentrations declined in a biphasic manner with a mean terminal elimination half-life (t 1/2) of 7.1 h (±1.3). There was no change in clearance or volume of distribution over the dose range studied. Due to cardiac toxicity occurring with both the parent compound, SR233377, as well as this analog, this series of agents was abandoned from further clinical development.
Morbidity and mortality after bowel resection for acute mesenteric ischemia.

Patients presenting with acute mesenteric ischemia (AMI) sufficiently advanced to require bowel resection have a high morbidity and mortality. The objective of this study was to analyze these patients to determine if certain pre- or intraoperative variables are predictive of death or complications which could then be used to develop a predictive model to aid in surgical decision-making.



Patients undergoing bowel resection for AMI were identified from the American College of Surgeons' National Surgical Quality Improvement Program database (2007-2008). Multiple logistic regression analysis was performed.



The 861 patients identified had a median age of 69 years. Thirty-day postoperative morbidity and mortality were 56.6% and 27.9%, respectively. Pre- and intraoperative variables significantly associated with postoperative mortality (C statistic, 0.84) included preoperative do not resuscitate order, open wound, low albumin, dirty vs clean-contaminated case, and poor functional status. Pre- and intraoperative variables significantly associated with postoperative morbidity (C statistic, 0.79) included admission from chronic care facility, recent myocardial infarction, chronic obstructive pulmonary disease, requiring ventilator support, preoperative renal failure, previous cardiac surgery, and prolonged operative time. A predictive risk calculator was developed using these variables.



Mortality and morbidity rates after bowel resection for AMI are high. A risk calculator for prediction of postoperative mortality and morbidity has been developed and awaits validation in subsequent studies.