nils-herrmann/clean_scirepeval huggingface dataset:
Effect of self-efficacy and social support on adherence to antihypertensive drugs.

To determine the relationship between poor adherence and self-efficacy or social support after a pharmacist intervention.



Post-hoc analysis of data from two randomized controlled trials of physician-pharmacist collaborative interventions (6 and 9 mo, respectively) to improve blood pressure control.



Eleven university-affiliated primary care clinics.



Five hundred eighty-four patients (aged 21-85 yrs) with uncontrolled primary hypertension; 296 were in the intervention group and 288 were in the control group.



Pharmacists provided intensified hypertension management and drug adherence counseling to patients in the intervention group.



Social support and self-efficacy questionnaires were administered at baseline and end-of-study visits. Patient adherence was monitored by using the Morisky self-reported adherence questionnaire. Self-reported adherence scores improved significantly in the control group (p=0.0053) but not in the intervention group; however, adherence at baseline in both groups was high. There were small, but significant, improvements in self-efficacy (p<0.04) and social support (p<0.05) scores in the intervention group but not the control group at the end of the study. Social support and, to a lesser extent, self-efficacy improved as a function of duration of study participation (9-mo vs 6-mo intervention), regardless of whether the patient received the intervention. Blood pressure control in both groups improved significantly at the end of the study; however, mean blood pressure was significantly lower in the intervention group (129.7/76.6 mm Hg) compared with the control group (140.8/78.9 mm Hg; p<0.0001 for systolic, p=0.032 for diastolic).



Social support and self-efficacy improved significantly in the intervention group at the end of the pharmacist intervention. Drug adherence was correlated with self-efficacy even though drug adherence did not improve significantly in the intervention group. The fact that social support and self-efficacy improved as a function of duration of study participation suggests that participation in a research study may have had a positive influence on these measures. Even though the changes in social support, self-efficacy, and drug adherence were modest, there was significantly better blood pressure control in the intervention group compared with the control group. These findings indicate that changes in drug adherence, self-efficacy, or social support probably played a minor role in the blood pressure outcomes in these studies.
Arthroscopic lavage of osteoarthritic knees.

A strong clinical impression exists that joint lavage often provides symptomatic relief for painful osteoarthritis of the knee. A controlled trial was conducted to test this hypothesis. A group of 37 painful osteoarthritic knees were treated by arthroscopic lavage and physiotherapy, and a control group of 24 knees were treated by physiotherapy alone. There was better relief of pain in the lavage group, and the effect was still present at one year. An improvement in the signs of inflammation lasted for about three months. Pain was relieved more effectively in patients with slight radiographic changes than in those with advanced changes. Our results confirm the effectiveness of joint lavage in the management of painful osteoarthritis of the knee.
The effect of low-level laser in knee osteoarthritis: a double-blind, randomized, placebo-controlled trial.

Low-level laser therapy (LLLT) is thought to have an analgesic effect as well as a biomodulatory effect on microcirculation. This study was designed to examine the pain-relieving effect of LLLT and possible microcirculatory changes measured by thermography in patients with knee osteoarthritis (KOA).



Patients with mild or moderate KOA were randomized to receive either LLLT or placebo LLLT. Treatments were delivered twice a week over a period of 4 wk with a diode laser (wavelength 830 nm, continuous wave, power 50 mW) in skin contact at a dose of 6 J/point. The placebo control group was treated with an ineffective probe (power 0.5 mW) of the same appearance. Before examinations and immediately, 2 wk, and 2 mo after completing the therapy, thermography was performed (bilateral comparative thermograph by AGA infrared camera); joint flexion, circumference, and pressure sensitivity were measured; and the visual analogue scale was recorded.



In the group treated with active LLLT, a significant improvement was found in pain (before treatment [BT]: 5.75; 2 mo after treatment : 1.18); circumference (BT: 40.45; AT: 39.86); pressure sensitivity (BT: 2.33; AT: 0.77); and flexion (BT: 105.83; AT: 122.94). In the placebo group, changes in joint flexion and pain were not significant. Thermographic measurements showed at least a 0.5 degrees C increase in temperature--and thus an improvement in circulation compared to the initial values. In the placebo group, these changes did not occur.



Our results show that LLLT reduces pain in KOA and improves microcirculation in the irradiated area.
Genomic association analysis identifies multiple loci influencing antihypertensive response to an angiotensin II receptor blocker.

Genomic Association Analysis Identifies Multiple Loci Influencing Antihypertensive Response to an Angiotensin II Receptor Blocker  The interesting article by Turner et al concerns the pharmacogenomics of the angiotensin receptor blocker Candesartan and the validation of the associated single-nucleotide polymorphisms by their opposite direction associations with blood pressure response to hydrochlorothiazide. We are also performing a pharmacogenomic study of the angiotensin receptor blocker Losartan and hydrochlorothiazide in a slightly larger sample of white-only, essential hypertensives, carefully recruited and followed up by the Italian Network for Pharmacogenomics of Hypertension over several years. All patients have been genotyped within the HYPERGENES project. The major differences between our and Turner’s study are as follows: (1) the genotyping array: missing genotypes were obtained by imputing (imputation quality ≥87%); (2) we used Losartan 50 mg instead of Candesartan 16 to 32 mg, hydrochlorothiazide dose being the same (results in the Table). The major limitation of both studies is the small sample size, leading to low statistical power. Also, if the bulk of our data are still under analysis, we have not been able to reproduce Turner’s specific findings. The present negative report is not at all against the importance of pharmacogenomics. It only poses a warning on the technical and methodological issues and indicates the absolute need of large consortia that share results to produce solid results.
Effects of montelukast (MK-0476); a potent cysteinyl leukotriene receptor antagonist, on bronchodilation in asthmatic subjects treated with and without inhaled corticosteroids.

Cysteinyl leukotriene release in association with airway inflammation is a feature of clinical asthma. The acute effects of montelukast (MK-0476), a potent, orally administered, specific cysteinyl leukotriene receptor antagonist, on airways obstruction was assessed in patients with mild to moderately severe asthma.



Twenty two asthmatic subjects were randomised to receive montelukast, 100 mg or 250 mg, or placebo in a double blind, three period, crossover trial. Ten of the patients were using concomitant inhaled corticosteroids.



Montelukast increased the forced expiratory volume in one second (FEV1) from predose baseline values compared with placebo, the percentage point differences between montelukast and placebo being 8.6% (95% CI 3.6 to 13.6) and 8.5% (95% CI 3.5 to 13.5) for the 100 mg and 250 mg doses, respectively.



Single oral doses of montelukast 100 mg and 250 mg produced significant increases in FEV1 irrespective of the concurrent use of inhaled corticosteroids in asthmatic subjects with airflow limitation.
Multicontrast high-resolution vessel wall magnetic resonance imaging and its value in differentiating intracranial vasculopathic processes.

Although studies have attempted to differentiate intracranial vascular disease using vessel wall magnetic resonance imaging (VWI), none have incorporated multicontrast imaging. This study uses T1- and T2-weighted VWI to differentiate intracranial vasculopathies.



We retrospectively reviewed patients with clinically defined intracranial vasculopathies causing luminal stenosis/irregularity who underwent VWI studies. Two blinded experts evaluated T1 precontrast and postcontrast and T2-weighted VWI characteristics, including the pattern of wall thickening; presence, pattern, and intensity of postcontrast enhancement; and T2 signal characteristics.



Twenty-one cases of atherosclerosis (intracranial atherosclerotic disease [ICAD]), 4 of reversible cerebral vasoconstriction syndrome, and 4 of vasculitis were identified, with a total of 118 stenotic lesions (81 ICAD, 22 reversible cerebral vasoconstriction syndrome, and 15 vasculitic lesions). There was substantial to excellent inter-reader agreement for the assessment of lesional T2 hyperintensity (κ=0.80), pattern of wall thickening (κ=0.87), presence (κ=0.90), pattern (κ=0.73), and intensity (κ=0.77) of enhancement. ICAD lesions were significantly more likely to have eccentric wall involvement (90.1%) than reversible cerebral vasoconstriction syndrome (8.2%; P<0.001) and vasculitic lesions (6.7%; P<0.001) and were also more likely to have T2 hyperintensity present than the other 2 vasculopathies (79% versus 0%; P<0.001). There were also significant differences in the presence, intensity, and pattern of enhancement between all lesion types. Combining T1 and T2 VWI increased the sensitivity of VWI in differentiating ICAD from other vasculopathies from 90.1% to 96.3%.



Multicontrast VWI can be a complementary tool for intracranial vasculopathy differentiation, which often leads to more invasive workups when reversible cerebral vasoconstriction syndrome and vasculitis are in the differential diagnosis.
Resistance exercise improves muscle strength, health status and pain intensity in fibromyalgia—a randomized controlled trial

Fibromyalgia (FM) is characterized by persistent widespread pain, increased pain sensitivity and tenderness. Muscle strength in women with FM is reduced compared to healthy women. The aim of this study was to examine the effects of a progressive resistance exercise program on muscle strength, health status, and current pain intensity in women with FM.



A total of 130 women with FM (age 22-64 years, symptom duration 0-35 years) were included in this assessor-blinded randomized controlled multi-center trial examining the effects of progressive resistance group exercise compared with an active control group. A person-centred model of exercise was used to support the participants' self-confidence for management of exercise because of known risks of activity-induced pain in FM. The intervention was performed twice a week for 15 weeks and was supervised by experienced physiotherapists. Primary outcome measure was isometric knee-extension force (Steve Strong®), secondary outcome measures were health status (FIQ total score), current pain intensity (VAS), 6MWT, isometric elbow-flexion force, hand-grip force, health related quality of life, pain disability, pain acceptance, fear avoidance beliefs, and patient global impression of change (PGIC). Outcomes were assessed at baseline and immediately after the intervention. Long-term follow up comprised the self-reported questionnaires only and was conducted after 13-18 months. Between-group and within-group differences were calculated using non-parametric statistics.



Significant improvements were found for isometric knee-extension force (p = 0.010), health status (p = 0.038), current pain intensity (p = 0.033), 6MWT (p = 0.003), isometric elbow flexion force (p = 0.02), pain disability (p = 0.005), and pain acceptance (p = 0.043) in the resistance exercise group (n = 56) when compared to the control group (n = 49). PGIC differed significantly (p = 0.001) in favor of the resistance exercise group at post-treatment examinations. No significant differences between the resistance exercise group and the active control group were found regarding change in self-reported questionnaires from baseline to 13-18 months.



Person-centered progressive resistance exercise was found to be a feasible mode of exercise for women with FM, improving muscle strength, health status, and current pain intensity when assessed immediately after the intervention.
Imatinib is effective in children with previously untreated chronic myelogenous leukemia in early chronic phase: results of the French national phase IV trial.

Imatinib is the standard of care in adults with chronic myeloid leukemia (CML) in chronic phase (CP). Only a few studies to assess efficacy in children have been performed. We report on the results of the French prospective trial (ClinicalTrials.gov identifier NCT00845221) conducted in children and adolescents with newly diagnosed CML in CP.



A total of 44 patients from age 10 months to 17 years with newly diagnosed CML in CP received daily imatinib 260 mg/m(2). Progression-free survival, responses, and tolerance were evaluated.



With a median follow-up times of 31 months (range, 11 to 64 months), the estimated progression-free survival rate at 36 months was 98% (95% CI, 85% to 100%). A complete hematologic response was achieved in 98% of the patients. The rates of complete cytogenetic response (CCyR) and major molecular response (MMR) were 61% and 31% at 12 months, respectively. During follow-up, CCyR and MMR were achieved in 36 children (77%) and 25 children (57%), respectively. Overall, 30% of the patients discontinued imatinib, mainly because of unsatisfactory response. The most common adverse events were neutropenia and musculoskeletal events.



Imatinib is effective in children with CML in CP with response rates similar to rates reported in adults. The adverse effects are acceptable, but longer follow-up studies are required to fully assess the long-term impact.
[Impact of an informative intervention on the colorectal cancer screening program in primary care professionals].

To evaluate the impact of an intervention in primary care professionals on their current knowledge about colorectal cancer screening, subsequent surveillance recommendations and referral strategies.



Cluster randomized controlled trial.


LOCATION
Primary Care Centers in L'Hospitalet de Llobregat (Barcelona).



Primary Care Professionals (doctors and nurses).



Training session in six of the 12 centers (randomly selected) about the colorrectal cancer screening program, and three emails with key messages.



Professionals and centers characteristics and two contextual variables; involvement of professionals in the screening program; information about colorectal cancer knowledge, risk factors, screening procedures, surveillance recommendations and referral strategies.



The total score mean on the first questionnaire was 8.07 (1.38) and the second 8.31 (1.39). No statistically significant differences between the intervention and control groups were found, however, in 9 out of 11 questions the percentage of correct responses was increased in the intervention group, mostly related to the surveillance after the diagnostic examination.



The intervention improves the percentage of correct answers, especially in those in which worst score obtained in the first questionnaire. This study shows that professionals are familiar with colorectal cancer screening, but there's a need to maintain frequent communication in order to keep up to date the information related to the colorectal cancer screening.
The reduction in blood loss with intra-articular injection of tranexamic acid in unilateral total knee arthroplasty without operative drains: a randomized controlled trial

The objective of this randomized controlled trial was to evaluate the efficacy and safety of intra-articular injections of tranexamic acid (TXA) on perioperative blood loss and transfusion in primary unilateral total knee arthroplasty (TKA) without drainage. Primary TKA was performed on a total of 80 patients (80 knees) affected to various degrees by knee osteoarthritis. The patients were randomized to receive 500 mg of TXA in 20 mL of normal saline solution (n = 40) or an equivalent volume of normal saline solution (n = 40), applied into the joint for 5 min at the end of surgery. Data on routine blood examination, blood loss and blood transfusion after TKA were compared between the two groups. The results showed no significant difference between the two groups in intra-operative blood loss (P = 0.136). The mean postoperative visible blood loss, hidden blood loss and transfusion requests were significantly different between the two groups (P < 0.05). The values of postoperative hemoglobin and hematocrit were lower in the control group compared with those in the treatment group (P < 0.05). No deep vein thrombosis was detected through Doppler ultrasound examination. Three hour postoperative D-dimer in the control group was higher than the treatment group (P = 0.02). There was no statistically significant difference between the coagulation indicators and range of motion in the two groups. We conclude that intra-articular TXA in patients undergoing unilateral TKA could significantly reduce postoperative blood loss and blood transfusion and avoid perioperative anemia-related complications without increased risk of venous thrombosis.
Quality of life in patients with K-RAS wild-type colorectal cancer: the CO.20 phase 3 randomized trial.

The CO.20 trial randomized patients with K-RAS wild-type, chemotherapy-refractory, metastatic colorectal cancer to receive cetuximab (CET) plus brivanib alaninate (BRIV) or CET plus placebo (CET/placebo).



Quality of life (QoL) was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 at baseline and at 2, 4, 6, 8, 12, 16, and 24 weeks until disease progression. Predefined coprimary QoL endpoints were time to deterioration (first worsening from baseline of ≥ 10 points) on the Physical Function (PF) and Global (GHS) scales.



Of 750 randomized patients, 721 (358 of whom received CET/BRIV) were assessable for QoL. QoL compliance and baseline PF and GHS scores did not differ by treatment arm. The median time to deterioration was 1.6 months versus 1.1 months for GHS (P =.02) and 5.6 months versus 1.7 months for PF (P <.0001) favoring CET/placebo. Secondary analysis favored CET/placebo for QOL response on the PF, Cognitive Function, Fatigue, Nausea, Appetite, and Diarrhea scales. A greater percentage of patients on the CET/BRIV arm had PF worsening at 6 weeks (31% vs 17%). Clinical adverse events of ≥ grade 3 were more common with CET/BRIV than with CET/placebo, including fatigue (25% vs 11%), hypertension, rash, diarrhea, abdominal pain, dehydration, and anorexia.



Compared with CET/placebo, the combination of CET/BRIV worsened time to QoL deterioration for patients with K-RAS wild-type, chemotherapy-refractory, metastatic colorectal cancer on the PF and GHS scales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30. This result may be due to higher rates of fatigue and gastrointestinal adverse events.
A rapid and efficient way to manage hyponatremia in patients with SIADH and small cell lung cancer: treatment with tolvaptan

Hyponatremia based on syndrome of inappropriate antidiuretic hormone hypersecretion (SIADH) is observed in up to 15% of patients with small cell lung cancer (SCLC). The electrolyte imbalance is associated with a high morbidity and mortality and often delays appropriate treatment. Management of hyponatremia proved to be challenging until new vasopressin-2 receptor antagonists such as tolvaptan became available. This is the first report which presents a prospective case series with an efficient management of hyponatremia including tolvaptan in ten patients with SCLC and severe SIADH (plasma sodium < 125 mmol/l).



Ten patients with SCLC and severe SIADH were followed after the onset of clinical symptoms of SIADH. Patients were chosen on the basis of histological proven diagnosis of SCLC and the clinical picture of a neurocognitive deficit caused by SIADH-related hyponatremia. All patient data were monitored for clinical improvement based on ECOG status, commencement of chemotherapy and correction of sodium levels.



The treatment followed a diagnostic and treatment algorithm and lead to a rapid and efficient correction of both clinical symptoms and plasma sodium level.



Based on this algorithm all patients started chemotherapy in time. Subsequently, the treatment with tolvaptan lead to an improvement of the ECOG-performance status. In addition, all patients benefit from the effective management of SIADH which omitted prolonged hospital stays and non-elective hospitalizations due to an unstable clinical condition due to severe hyponatremia. These observations add new insight to management of SIADH in thoracic oncology and are of interest for specialists in oncology, endocrinology and pulmonary medicine.
Exercise and nutrition for head and neck cancer patients: a patient oriented, clinic-supported randomized controlled trial

Research on physical activity and nutrition interventions aimed at positively impacting symptom management, treatment-related recovery and quality of life has largely excluded head and neck (HN) cancer populations. This translates into a lack of clinical programming available for these patient populations. HN cancer patients deal with severe weight loss, with more than 70% attributed to lean muscle wasting, leading to extended recovery times, decreased quality of life (QoL), and impaired physical functioning. To date, interventions to address body composition issues have focused solely on diet, despite findings that nutritional therapy alone is insufficient to mitigate changes. A combined physical activity and nutrition intervention, that also incorporates important educational components known to positively impact behaviour change, is warranted for this population. Our pilot work suggests that there is large patient demand and clinic support from the health care professionals for a comprehensive program. Therefore, the purpose of the present study is to examine the impact and timing of a 12-week PA and nutrition intervention (either during or following treatment) for HN cancer patients on body composition, recovery, serum inflammatory markers and quality of life. In addition, we will examine the impact of a 12-week maintenance program, delivered immediately following the intervention, on adherence, patient-reported outcomes (i.e., management of both physical and psychosocial treatment-related symptoms and side-effects), as well as return to work. This research will facilitate advancements in patient wellness, survivorship, and autonomy, and carve the path for a physical-activity and wellness-education model that can be implemented in other cancer centers. Current Controlled Trials NCT01681654