nils-herrmann/clean_scirepeval huggingface dataset:
Efficacy and safety of multiple doses of QGE031 (ligelizumab) versus omalizumab and placebo in inhibiting allergen-induced early asthmatic responses.

Omalizumab is an established anti-IgE therapy for the treatment of allergic diseases that prevents IgE from binding to its receptor. QGE031 is an investigational anti-IgE antibody that binds IgE with higher affinity than omalizumab.



This study compared the effects of QGE031 with those of omalizumab on clinical efficacy, IgE levels, and FcεRI expression in a clinical model of allergic asthma.



Thirty-seven patients with mild allergic asthma were randomized to subcutaneous omalizumab, placebo, or QGE031 at 24, 72, or 240 mg every 2 weeks for 10 weeks in a double-blind, parallel-group multicenter study. Inhaled allergen challenges and skin tests were conducted before dosing and at weeks 6, 12, and 18, and blood was collected until 24 weeks after the first dose.



QGE031 elicited a concentration- and time-dependent change in the provocative concentration of allergen causing a 15% decrease in FEV1 (allergen PC15) that was maximal and approximately 3-fold greater than that of omalizumab (P = .10) and 16-fold greater than that of placebo (P = .0001) at week 12 in the 240-mg cohort. Skin responses reached 85% suppression at week 12 in the 240-mg cohort and were maximal at week 18. The top doses of QGE031 consistently suppressed skin test responses among subjects but had a variable effect on allergen PC15 (2-fold to 500-fold change). QGE031 was well tolerated.



QGE031 has greater efficacy than omalizumab on inhaled and skin allergen responses in patients with mild allergic asthma. These data support the clinical development of QGE031 as a treatment of asthma.
Phase I study of the novel taxane CT-2103 in patients with advanced solid tumors

Wash.) is a water-soluble macromolecular conjugate of paclitaxel to a polyglutamate backbone, designed to enhance tumor permeability and to improve intratumoral delivery of paclitaxel. Preclinical studies indicate that CT-2103 has substantial antitumor efficacy in xenograft tumor models. We performed a phase I trial in patients with advanced solid tumors to determine the maximum tolerated doses (MTD) of CT-2103 when administered as short intravenous infusion every 3 weeks. Seven patients received a total of 16 cycles (range 1–3) of CT-2103 at doses of 235 and 270 mg/m2. Two of five patients treated at 235 mg/m2 and one of two patients treated at 270 mg/m2 experienced grade 3/4 neutropenia. Four patients experienced a marked increase in PTT within 30 min of the start of infusion. Neuropathy was more severe than expected. Two patients developed grade 3 neuropathy that prompted a 50% dose reduction of CT-2103 and persisted for 8 months in one, and over a year in the other. Three patients experienced grade 1 or 2 neuropathy. Neurotoxicity was cumulative and prevented patients from receiving prolonged administration of CT-2103. The unexpectedly high rate of cumulative toxicity observed in our study needs to be taken into consideration in future trials of CT-2103. Prior taxane use may not be a predictor of severe neurotoxicity.
Effect of a cash transfer programme for schooling on prevalence of HIV and herpes simplex type 2 in Malawi: a cluster randomised trial

Lack of education and an economic dependence on men are often suggested as important risk factors for HIV infection in women. We assessed the efficacy of a cash transfer programme to reduce the risk of sexually transmitted infections in young women.



In this cluster randomised trial, never-married women aged 13-22 years were recruited from 176 enumeration areas in the Zomba district of Malawi and randomly assigned with computer-generated random numbers by enumeration area (1:1) to receive cash payments (intervention group) or nothing (control group). Intervention enumeration areas were further randomly assigned with computer-generated random numbers to conditional (school attendance required to receive payment) and unconditional (no requirements to receive payment) groups. Participants in both intervention groups were randomly assigned by a lottery to receive monthly payments ranging from US$1 to $5, while their parents were independently assigned with computer-generated random numbers to receive $4-10. Behavioural risk assessments were done at baseline and 12 months; serology was tested at 18 months. Participants were not masked to treatment status but counsellors doing the serologic testing were. The primary outcomes were prevalence of HIV and herpes simplex virus 2 (HSV-2) at 18 months and were assessed by intention-to-treat analyses. The trial is registered, number NCT01333826.



88 enumeration areas were assigned to receive the intervention and 88 as controls. For the 1289 individuals enrolled in school at baseline with complete interview and biomarker data, weighted HIV prevalence at 18 month follow-up was 1·2% (seven of 490 participants) in the combined intervention group versus 3·0% (17 of 799 participants) in the control group (adjusted odds ratio [OR] 0·36, 95% CI 0·14-0·91); weighted HSV-2 prevalence was 0·7% (five of 488 participants) versus 3·0% (27 of 796 participants; adjusted OR 0·24, 0·09-0·65). In the intervention group, we noted no difference between conditional versus unconditional intervention groups for weighted HIV prevalence (3/235 [1%] vs 4/255 [2%]) or weighted HSV-2 prevalence (4/233 [1%] vs 1/255 [<1%]). For individuals who had already dropped out of school at baseline, we detected no significant difference between intervention and control groups for weighted HIV prevalence (23/210 [10%] vs 17/207 [8%]) or weighted HSV-2 prevalence (17/211 [8%] vs 17/208 [8%]).



Cash transfer programmes can reduce HIV and HSV-2 infections in adolescent schoolgirls in low-income settings. Structural interventions that do not directly target sexual behaviour change can be important components of HIV prevention strategies.



Global Development Network, Bill & Melinda Gates Foundation, National Bureau of Economic Research Africa Project, World Bank's Research Support Budget, and several World Bank trust funds (Gender Action Plan, Knowledge for Change Program, and Spanish Impact Evaluation fund).
Do people with recurrent back pain constrain spinal motion during seated horizontal and downward reaching?

Although the effect of symptomatic back pain on functional movement has been investigated, changes to spinal movement patterns in essentially pain-free people with a history of recurrent back pain are largely unreported. Reaching activities, important for everyday and occupational function, often present problems to such people, but have not been considered in this population. The purpose of this study was to compare the amplitude and timing of spinal and hip motions during two, seated reaching activities in people with and without a history of recurrent low back pain (RLBP).



Spinal and hip motions during reaching downward and across the body, in both directions, were tracked using electromagnetic sensors. Analyses were conducted to explore the amplitudes, velocities and timings of 3D segmental movements and to compare controls with subjects with recurrent, but asymptomatic lumbar or lumbosacral pain.



We detected significant differences in the amplitude and timing of movement in the lower thoracic region, with the RLBP group restricting movement and demonstrating compensatory increased motion at the hip. The lumbar region displayed no significant between-group differences. The order in which the spinal segments achieved peak velocity in cross-reaching was reversed in RLBP compared to controls, with lumbar motion leading in controls and lagging in RLBP.



Subjects with a history of RLBP show a number of altered kinematic features during reaching activities which are not related to the presence or intensity of pain, but which suggest adaptive changes to movement control.
Patient characteristics and practice patterns in the treatment of acute myocardial infarction in Kuwait: a pilot study.

To determine the characteristics, management and outcomes of patients with acute myocardial infarction (AMI) admitted to the general hospitals and to assess the feasibility of establishing a registry for AMI in Kuwait.



We prospectively included 111 consecutive patients (94 males and 17 females, mean age 55 years) admitted to the coronary care units of the five participating hospitals during May 2000. The subjects all had a final diagnosis of AMI. A structured data collection form that included biochemical measurements was filled out for each patient.



The prevalence of hypercholesterolemia, diabetes, hypertension and current smoking was 46, 45, 30 and 49%, respectively. Fifty-four of 57 patients who were eligible for thrombolytic therapy received treatment. The median time from symptom onset to thrombolytic therapy was 180 min. At discharge 93% were prescribed aspirin, 81% beta-blockers, 40% angiotensin-converting enzyme inhibitors, and 32% lipid-lowering drugs. The in-hospital mortality was 10%.



The incidence of smoking, diabetes and hypercholesterolemia is high among our patients. Thrombolytic therapy is used regularly but insufficiently early. Based on this pilot study, it is feasible to establish an AMI registry in Kuwait.
Combination therapy with pulsed methylprednisolone in rheumatoid arthritis.

Pulsed methylprednisolone (PMP) has been shown to produce clinical improvement and reduction in the ESR and acute phase protein concentrations in patients with active rheumatoid arthritis and has been advocated for use either as an alternative to slow-acting antirheumatoid drugs (SAARDs) or in conjunction with SAARDs to accelerate the response to treatment. To test these potential roles for PMP 45 patients with active RA were randomly allocated to treatment with PMP alone, PMP + sulphasalazine (SAS - at a maintenance dose of 2.0 g/day), or PMP + D-penicillamine (DPA - at a maintenance dose of 500 mg/day). In each case three 1 g intravenous infusions were given on alternate days during the first week of the trial. Patients were monitored for 24 weeks by standard clinical and laboratory measurements. All three treatment groups showed significant clinical and laboratory improvements at two weeks. With PMP + DPA and PMP + SAS these improvements were sustained and were not significantly different in these two treatment groups. However, in the 'PMP only' group ESR and CRP rose to pretreatment values by eight weeks. Twelve patients withdrew from the study owing to a relapse of the RA. No serious adverse effects were seen in the 'PMP only' group. Both combination regimens were well tolerated; adverse effects seen were attributable to either DPA or SAS. We conclude that PMP alone is insufficient for treatment of RA but can be used successfully in combination with either DPA or SAS. A comparison between these results obtained from two previous groups of 15 patients treated with DPA alone and SAS alone (using the same study design) shows that PMP accelerated the response to therapy by at least six weeks.
Optimal cut-off value for homeostasis model assessment (HOMA) index of insulin-resistance in a population of patients admitted electively in a Portuguese cardiology ward.

Insulin resistance is the pathophysiological key to explain metabolic syndrome. Although clearly useful, the Homeostasis Model Assessment index (an insulin resistance measurement) has not been systematically applied in clinical practice. One of the main reasons is the discrepancy in cut-off values reported in different populations. We sought to evaluate in a Portuguese population the ideal cut-off for Homeostasis Model Assessment index and assess its relationship with metabolic syndrome.



We selected a cohort of individuals admitted electively in a Cardiology ward with a BMI < 25 Kg/m2 and no abnormalities in glucose metabolism (fasting plasma glucose < 100 mg/dL and no diabetes). The 90th percentile of the Homeostasis Model Assessment index distribution was used to obtain the ideal cut-off for insulin resistance. We also selected a validation cohort of 300 individuals (no exclusion criteria applied).



From 7 000 individuals, and after the exclusion criteria, there were left 1 784 individuals. The 90th percentile for Homeostasis Model Assessment index was 2.33. In the validation cohort, applying that cut-off, we have 49.3% of individuals with insulin resistance. However, only 69.9% of the metabolic syndrome patients had insulin resistance according to that cut-off. By ROC curve analysis, the ideal cut-off for metabolic syndrome is 2.41. Homeostasis Model Assessment index correlated with BMI (r = 0.371, p < 0.001) and is an independent predictor of the presence of metabolic syndrome (OR 19.4, 95% CI 6.6 - 57.2, p < 0.001).



Our study showed that in a Portuguese population of patients admitted electively in a Cardiology ward, 2.33 is the Homeostasis Model Assessment index cut-off for insulin resistance and 2.41 for metabolic syndrome.



Homeostasis Model Assessment index is directly correlated with BMI and is an independent predictor of metabolic syndrome.
Italian translation, cultural adaptation and validation of the PedsQL™ 3.0 Diabetes Module questionnaire in children with type 1 diabetes and their parents

The PedsQL™3.0 Diabetes Module is a widely used instrument to measure the disease-specific health-related quality of life summary measures in children and adolescents with type 1 diabetes. After cultural adaptation, we confirmed reliability and validity of PedsQL™3.0 Diabetes Module in its Italian version.



Participants were 169 Italian children and adolescents with type 1 diabetes aged 5-18 years and 100 parents. Reliability was determined by internal consistency using Cronbach's coefficient alpha, and test-retest reliability by intra-class correlation coefficient (ICC). Validity was assessed through factor validity examined by exploratory factor analysis, and discriminant validity examined through multitrait/multi-item scaling analysis. Discriminant validity with respect to dichotomous patients' characteristics at baseline was also examined through a multivariate analysis on the summary measures using the Wilks' Lambda test.



Data completeness was optimal. Item internal consistency was satisfied at 89% for the child self-report scales and at 100% for the parents' proxy-report scales. Most diabetes module scales was acceptable for group comparisons. Discriminant validity was satisfied for 71% of children and adolescents and for 82% of parents. A ≥70% Cronbach's α coefficient was found for the summary measures of both reports. For the test-retest reliability, the ICC coefficients ranged from 0.66 (i.e., the Worry scale) to 0.82 for the other scales of the child self-report. The ICC coefficients were ≥0.87 for all the parents' proxy-report scales. Factor analysis showed that the PedsQL™3.0 Diabetes Module for child self-report could be summarized in 10 components, which explained the 62% of the variance. For the parent proxy-report the statistical analysis selected 9 factors, which explained about 68% of variance. The external discriminant validity of the PedsQL™3.0 Diabetes Module summary measures were compared across gender, age, time since diagnosis and HbA1c mean cut off values. Significant differences in the "Treatment adherence" scale and in the "Communication" scale were observed across age, and by time since diagnosis.



The results show the reliability and validity of the Italian translation of the PedsQL™3.0 Diabetes Module, supporting therefore its use as an outcome measure for diabetes cross-national clinical trials and research.
Perceived stress mediates the relationship between emotional loneliness and sleep quality over time in older adults.

Both loneliness and poor sleep quality are common occurrences in late life and both are detrimental to physical and mental health. While loneliness may be difficult to intervene upon, there may be correlated factors, which, if alleviated, could mitigate the effects of loneliness and sleep quality on health in late life.



A longitudinal, observational study whereby we gathered predictive variables at baseline and dependent variable (sleep) at follow-up.



We investigated the relationship between loneliness at baseline and sleep quality at follow-up in a group of 447 older adults attending the clinic for research participation. Loneliness, stress and sleep quality were all measured using self-report validated psychometric tools.



We found that loneliness, specifically emotional loneliness, predicted sleep quality at follow-up, controlling for demographic factors and for sleep quality at baseline. Upon applying mediation methods to the data, we then found that this relationship was mediated in part by perceived stress.



We conclude that the impact of emotional loneliness on sleep quality in older adults is partly because of the stress experienced as a result of feeling lonely.
Treatment of gastric ulceration with carbenoxolone sodium: clinical and radiological evaluation.

Gastric ulcers have a natural tendency towards healing, and a controlled therapeutic trial is the only reliable method for assessing the value of any method of treatment. This paper reports our experience with carbenoxolone, and confirms the studies of Doll et al. (1962). Carefully controlled trials have shown the following treatments to be ineffective: cabbage juice (Doll and Pygott, 1954); Robaden, an extract of gastro-intestinal tissue (Doll and Pygott, 1954) ; an extract of brain (Brochner-Mortensen et al., 1955) ; alkalis and continuous milk (Doll et al., 1956). Doll and Pygott (1952) compared the effect of bed rest of in-patients with ambulant treatment of out-patients, and found that 56% of ulcers treated by bed rest healed by two-thirds or more. Doll et al. (1958) showed that stopping smoking helped to heal gastric ulcers. In the trial of carbenoxolone reported by Doll et al. (1962), of 30 patients receiving the drug 70% healed by two-thirds
Measurement properties of the German Michigan Hand Outcomes Questionnaire in patients with trapeziometacarpal osteoarthritis.

To investigate the reliability, validity, and responsiveness of the Michigan Hand Outcomes Questionnaire (MHQ) in patients with trapeziometacarpal (TMC) joint osteoarthritis (OA).



In this prospective observational study, patients diagnosed with TMC joint OA who received either conservative or surgical treatment were included. At baseline and at 1 year following the beginning of treatment, we measured key pinch strength and the patients filled out the MHQ, the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, and the Short Form 12 health survey. Patients also completed these questionnaires 2-11 days after the last study visit. In order to analyze the measurement properties of the MHQ, we calculated test-retest reliability (intraclass correlation coefficient [ICC]), internal consistency (Cronbach's alpha for the 6 subscales), construct validity (Pearson's correlation coefficient [r]), responsiveness (effect sizes), and the minimum important change (MIC).



We included 177 patients, of whom 109 were scheduled for surgery. The mean ± SD MHQ total score for surgical patients increased from 48 ± 14 at baseline to 75 ± 18 at 1 year (P ≤ 0.001). In contrast, no treatment effect was observed in the conservative group (P = 0.74). The MHQ total score showed excellent test-retest reliability (ICC 0.95) and correlated strongly with the DASH (r = -0.77). Internal consistency of the MHQ subscales ranged between 0.77 and 0.89. A large effect size of 1.7 was found for the surgical patients, with an MIC of 17 points.



The MHQ demonstrated good reliability, validity, and responsiveness in patients with TMC joint OA and can be recommended as a suitable assessment instrument in this population.
Self-management support using an Internet-linked tablet computer (the EDGE platform)-based intervention in chronic obstructive pulmonary disease: protocol for the EDGE-COPD randomised controlled trial

The potential for telehealth-based interventions to provide remote support, education and improve self-management for long-term conditions is increasingly recognised. This trial aims to determine whether an intervention delivered through an easy-to-use tablet computer can improve the quality of life of patients with chronic obstructive pulmonary disease (COPD) by providing personalised self-management information and education.



The EDGE (sElf management anD support proGrammE) for COPD is a multicentre, randomised controlled trial designed to assess the efficacy of an Internet-linked tablet computer-based intervention (the EDGE platform) in improving quality of life in patients with moderate to very severe COPD compared with usual care. Eligible patients are randomly allocated to receive the tablet computer-based intervention or usual care in a 2:1 ratio using a web-based randomisation system. Participants are recruited from respiratory outpatient clinics and pulmonary rehabilitation courses as well as from those recently discharged from hospital with a COPD-related admission and from primary care clinics. Participants allocated to the tablet computer-based intervention complete a daily symptom diary and record clinical symptoms using a Bluetooth-linked pulse oximeter. Participants allocated to receive usual care are provided with all the information given to those allocated to the intervention but without the use of the tablet computer or the facility to monitor their symptoms or physiological variables. The primary outcome of quality of life is measured using the St George's Respiratory Questionnaire for COPD patients (SGRQ-C) baseline, 6 and 12 months. Secondary outcome measures are recorded at these intervals in addition to 3 months.


ETHICS AND DISSEMINATION
The Research Ethics Committee for Berkshire-South Central has provided ethical approval for the conduct of the study in the recruiting regions. The results of the study will be disseminated through peer review publications and conference presentations.