nils-herrmann/clean_scirepeval huggingface dataset:
Effectiveness of a New Exercise Program after Lower Limb Arterial Blood Flow Surgery in Patients with Peripheral Arterial Disease: A Randomized Clinical Trial

The aim of this study was to evaluate the effectiveness of a supervised exercise program (SEP) plus at home nonsupervised exercise therapy (non-SET) on functional status, quality of life (QoL) and hemodynamic response in post-lower-limb bypass surgery patients.



One hundred and seventeen patients were randomized to an intervention (n = 57) or a control group (n = 60). A new individual SEP was designed for patients with peripheral arterial disease (PAD) and applied to the studied subjects of the intervention group who also continued non-SET at home, whereas those assigned to the control group received just usual SEP according to a common cardiovascular program. The participants of the study were assessed by a 6-min walking test (6 MWT), an ankle-brachial index (ABI), and the Medical Outcomes Study Short Form-36 (SF-36) of QoL at baseline, at 1 and 6 months after surgery. A significant improvement was observed in the walked distance in the intervention group after 6 months compared with the control group (p < 0.001). The intervention group had significantly higher QoL score in the physical and mental component of SF-36 (p < 0.05).



A 6-month application of the new SEP and non-SET at home has yielded significantly better results in walking distance and QoL in the intervention group than in the controls.
Intrathecal substance P-saporin in the dog: efficacy in bone cancer pain.

Substance P-saporin (SP-SAP), a chemical conjugate of substance P and a recombinant version of the ribosome-inactivating protein, saporin, when administered intrathecally, acts as a targeted neurotoxin producing selective destruction of superficial neurokinin-1 receptor-bearing cells in the spinal dorsal horn. The goal of this study was to provide proof-of-concept data that a single intrathecal injection of SP-SAP could safely provide effective pain relief in spontaneous bone cancer pain in companion (pet) dogs.



In a single-blind, controlled study, 70 companion dogs with bone cancer pain were randomized to standard-of-care analgesic therapy alone (control, n=35) or intrathecal SP-SAP (20-60 µg) in addition to standard-of-care analgesic therapy (n=35). Activity, pain scores, and videography data were collected at baseline, 2 weeks postrandomization, and then monthly until death.



Although the efficacy results at the 2-week postrandomization point were equivocal, the outcomes evaluated beyond 2 weeks revealed a positive effect of SP-SAP on chronic pain management. Significantly, more dogs in the control group (74%) required unblinding and adjustment in analgesic protocol or euthanasia within 6 weeks of randomization than dogs that were treated with SP-SAP (24%; P<0.001); and overall, dogs in the control group required unblinding significantly sooner than dogs that had been treated with SP-SAP (P<0.01).



Intrathecal administration of SP-SAP in dogs with bone cancer produces a time-dependent antinociceptive effect with no evidence of development of deafferentation pain syndrome which can be seen with neurolytic therapies.
Coordination of communication: effects of shared visual context on collaborative work

We outline some of the benefits of shared visual information for collaborative repair tasks and report on a study comparing collaborative performance on a manual task by workers and helpers who are located side-by-side or connected via audio-video or audio-only links. Results show that the dyads complete the task more quickly and accurately when helpers are co-located than when they are connected via an audio link. However, they didn't achieve similar efficiency gains when they communicated through an audio/video link. These results demonstrate the value of a shared visual work space, but raise questions about the adequacy of current video communication technology for implementing it.
Long-term effects of noise reduction measures on noise annoyance and sleep disturbance: the Norwegian facade insulation study.

The Norwegian facade insulation study includes one pre-intervention and two post-intervention surveys. The facade-insulating measures reduced indoor noise levels by 7 dB on average. Before the intervention, 43% of the respondents were highly annoyed by noise. Half a year after the intervention, the proportion of respondents who were highly annoyed by road traffic noise had been significantly reduced to 15%. The second post-intervention study (2 yr after the first post-intervention study) showed that the proportion of highly annoyed respondents had not changed since the first post-intervention study. The reduction in the respondents' self-reported sleep disturbances (due to traffic noise) also remained relatively stable from the first to the second post-intervention study. In the control group, there were no statistically significant differences in annoyance between the pre-intervention and the two post-intervention studies. Previous studies of traffic changes have reported that people "overreact" to noise changes. This study indicated that when considering a receiver measure, such as facade insulation, the effect of reducing indoor noise levels could be predicted from exposure-response curves based on previous studies. Thus no evidence of an "overreaction" was found.
A Phase 3 Trial of Sebelipase Alfa in Lysosomal Acid Lipase Deficiency.

Lysosomal acid lipase is an essential lipid-metabolizing enzyme that breaks down endocytosed lipid particles and regulates lipid metabolism. We conducted a phase 3 trial of enzyme-replacement therapy in children and adults with lysosomal acid lipase deficiency, an underappreciated cause of cirrhosis and severe dyslipidemia.



In this multicenter, randomized, double-blind, placebo-controlled study involving 66 patients, we evaluated the safety and effectiveness of enzyme-replacement therapy with sebelipase alfa (administered intravenously at a dose of 1 mg per kilogram of body weight every other week); the placebo-controlled phase of the study was 20 weeks long and was followed by open-label treatment for all patients. The primary end point was normalization of the alanine aminotransferase level. Secondary end points included additional disease-related efficacy assessments, safety, and side-effect profile.



Substantial disease burden at baseline included a very high level of low-density lipoprotein cholesterol (≥190 mg per deciliter) in 38 of 66 patients (58%) and cirrhosis in 10 of 32 patients (31%) who underwent biopsy. A total of 65 of the 66 patients who underwent randomization completed the double-blind portion of the trial and continued with open-label treatment. At 20 weeks, the alanine aminotransferase level was normal in 11 of 36 patients (31%) in the sebelipase alfa group and in 2 of 30 (7%) in the placebo group (P=0.03), with mean changes from baseline of -58 U per liter versus -7 U per liter (P<0.001). With respect to prespecified key secondary efficacy end points, we observed improvements in lipid levels and reduction in hepatic fat content (P<0.001 for all comparisons, except P=0.04 for triglycerides). The number of patients with adverse events was similar in the two groups; most events were mild and were considered by the investigator to be unrelated to treatment.



Sebelipase alfa therapy resulted in a reduction in multiple disease-related hepatic and lipid abnormalities in children and adults with lysosomal acid lipase deficiency.
Ophthalmic nurse practitioner led diabetic retinopathy screening. Results of a 3-month trial

PurposeTo describe the design and implementation of a nurse led diabetic retinopathy screening clinic. To present the results of a 3-month trial period assessing the concordance of retinopathy grading between a nurse practitioner and an ophthalmologist.MethodPatients attending for annual diabetic eye review during an initial 3-month trial period were assessed in a dedicated diabetic eye clinic by an ophthalmic nurse practitioner and an ophthalmologist, with both grading the degree of diabetic retinopathy using to the Wisconsin grading system. Each was masked as to the other's findings. The concordance of retinopathy grading between ophthalmic nurse practitioner and ophthalmologist was assessed. total of 95 patients (189 eyes) were assessed during the study period. A 92% concordance was achieved between the ophthalmologist and the ophthalmic nurse practitioner. In total, 72 eyes were graded as having some degree of retinopathy by the ophthalmologist. The sensitivity of the nurse practitioner for diagnosing the presence of diabetic retinopathy was 93%, and the specificity 91%. Nine eyes with severe nonproliferative diabetic retinopathy or worse, and four with clinically significant macular oedema were seen. All were correctly identified by the nurse practitioner.ConclusionsThe structure and management protocols of the clinic are described. An excellent concordance between ophthalmologist and nurse practitioner was achieved in this group of patients with relatively less advanced retinopathy.
A randomized comparative trial of generalized vs targeted physiotherapy in the management of childhood hypermobility.

Joint hypermobility, common in childhood, can be associated with severe pain and significant morbidity. Physiotherapy, the mainstay of treatment, lacks a robust evidence base. This study is aimed at determining the best physiotherapy intervention in managing childhood hypermobility.



A prospective randomized comparative trial (RCT) compared a 6-week generalized programme, improving muscular strength and fitness, with a targeted programme aimed at correcting motion control of symptomatic joints. Patients were assessed on symptom scores (pain/global-impact), function, muscle strength and fitness.



Fifty-seven children, aged 7-16 years with symptomatic hypermobility, were randomly assign to receive a targeted (T; n = 30) or generalized (G; n = 27) programme. Statistically significant improvements were demonstrated in both the children's and parental pain scores across both the randomized groups between baseline and follow-up assessments (P < 0.05). However, the difference in improvement between the groups was not statistically significant. Child's assessment of change in pain score: mean difference (95% CI) T - G, 3.97 (-15.59, 20.85) at the end of treatment and 9.41 at 3-month follow-up (-17.42, 36.24). At the end of treatment, parental assessment of change in pain score, T - G was: -0.27 (-15.05, 14.50) and at 3-month follow-up it was: -9.48 (-26.40, 7.43). Change in parental global assessment was statistically significant, in favour of targeted physiotherapy at final assessment: -21.29 (-40.03, -2.55).



This is the first physiotherapy RCT for treating hypermobility. It demonstrated significant and sustained reduction in pain when both groups were combined, but did not detect any difference between the groups. This study provides normative and methodological data for future studies of hypermobility.
Aspirin-induced hepatic dysfunction in a patient with adult rheumatoid arthritis

A patient with classical rheumatoid arthritis receiving high doses of aspirin developed significant elevation of serum glutamic oxaloacetic transaminase. This patient had recently been on phenylbutazone and an initial liver biopsy, at the time of elevation of the transaminase revealed nonspecific mild fatty infiltration of the liver compatible with the pathology seen with rheumatoid disease. Because of the severity and activity of her rheumatoid arthritis, and thus the need to know whether aspirin was the etiologic factor in liver dysfunction, the patient was challenged with aspirin. SGOT elevation occurred after a 4–6-day lag period, which promptly remitted when salicylates were discontinued. A liver biopsy at this time revealed evidence for degeneration, regeneration, and mild focal mononuclear infiltration. Although previous reports note salicylate-related hepatocellular dysfunction in patients with systemic lupus erythematosus and juvenile rheumatoid arthritis, these data clearly demonstrate the relationship of ASA to liver dysfunction in a patient with adult onset rheumatoid arthritis. The histologic picture as well as the clinical course of this patient's hepatic abnormality suggest a toxic rather than hypersensitivity etiology for this syndrome.
Outcome of allogeneic hematopoietic stem-cell transplantation for adult patients with AML and 11q23/MLL rearrangement (MLL-r AML)

Acute myeloid leukemia (AML) with 11q23/MLL rearrangement (MLL-r AML) is allocated to the intermediate- or high-risk cytogenetic prognostic category depending on the MLL fusion partner. A more favorable outcome has been reported in patients receiving an allogeneic hematopoietic stem-cell transplantation (alloHSCT), but this has not been confirmed in large series. We analyzed the outcome of alloHSCT among adult patients reported to the Acute Leukemia Working Party between 2000 and 2010. We identified 159 patients with 11q23/MLL rearranged AML allografted in first complete remission (CR1, n=138) or CR2, mostly corresponding to t(9;11), t(11;19), t(6;11) and t(10;11) translocations. Two-year overall survival (OS), leukemia-free survival (LFS), relapse incidence and non-relapse mortality were 56±4%, 51±4%, 31±3% and 17±4%, respectively. The outcome differed according to 11q23/MLL rearrangement, being more favorable in patients with t(9;11) and t(11;19) compared with t(10;11) and t(6;11) (2-year OS: 64±6% and 73±10% vs 40±13% and 24±11%, respectively; P<0.0001). Multivariate analysis for OS identified t(6;11), t(10;11), age>40 years and CR2 as unfavorable features, whereas t(6;11), t(10;11), CR2 and the use of reduced-intensity conditioning regimen affected poorly the LFS. This study confirms the potential role of alloHSCT for adult patients with 11q23/MLL rearranged AML in CR1.
Direct implantation of rapamycin-eluting stents with bioresorbable drug carrier technology utilising the Svelte coronary stent-on-a-wire: the DIRECT II study.

Our aim was to demonstrate the safety and efficacy of the Svelte sirolimus-eluting coronary stent-on-a-wire Integrated Delivery System (IDS) with bioresorbable drug coating compared to the Resolute Integrity zotarolimus-eluting stent with durable polymer in patients with de novo coronary artery lesions.



Direct stenting, particularly in conjunction with transradial intervention (TRI), has been associated with reduced bleeding complications, procedure time, radiation exposure and contrast administration compared to conventional stenting with wiring and predilatation. The low-profile Svelte IDS is designed to facilitate TRI and direct stenting, reducing the number of procedural steps, time and cost associated with coronary stenting. DIRECT II was a prospective, multicentre trial which enrolled 159 patients to establish non-inferiority of the Svelte IDS versus Resolute Integrity using a 2:1 randomisation. The primary endpoint was angiographic in-stent late lumen loss (LLL) at six months. Target vessel failure (TVF), as well as secondary clinical endpoints, will be assessed annually up to five years. At six months, in-stent LLL was 0.09±0.31 mm in the Svelte IDS group compared to 0.13±0.27 mm in the Resolute Integrity group (p<0.001 for non-inferiority). TVF at one year was similar across the Svelte IDS and Resolute Integrity groups (6.5% vs. 9.8%, respectively).



DIRECT II demonstrated the non-inferiority of the Svelte IDS to Resolute Integrity with respect to in-stent LLL at six months. Clinical outcomes at one year were comparable between the two groups.
Adalimumab maintains remission of Crohn's disease after up to 4 years of treatment: data from CHARM and ADHERE

Therapies that maintain remission for patients with Crohn's disease are essential. Stable remission rates have been demonstrated for up to 2 years in adalimumab-treated patients with moderately to severely active Crohn's disease enrolled in the CHARM and ADHERE clinical trials.



To present the long-term efficacy and safety of adalimumab therapy through 4 years of treatment.



Remission (CDAI <150), response (CR-100) and corticosteroid-free remission over 4 years, and maintenance of these endpoints beyond 1 year were assessed in CHARM early responders randomised to adalimumab. Corticosteroid-free remission was also assessed in all adalimumab-randomised patients using corticosteroids at baseline. Fistula healing was assessed in adalimumab-randomised patients with fistula at baseline. As observed, last observation carried forward and a hybrid nonresponder imputation analysis for year 4 (hNRI) were used to report efficacy. Adverse events were reported for any patient receiving at least one dose of adalimumab.



Of 329 early responders randomised to adalimumab induction therapy, at least 30% achieved remission (99/329) or CR-100 (116/329) at year 4 of treatment (hNRI). The majority of patients (54%) with remission at year 1 maintained this endpoint at year 4 (hNRI). At year 4, 16% of patients taking corticosteroids at baseline were in corticosteroid-free remission and 24% of patients with fistulae at baseline had healed fistulae. The incidence rates of adverse events remained stable over time.



Prolonged adalimumab therapy maintained clinical remission and response in patients with moderately to severely active Crohn's disease for up to 4 years. No increased risk of adverse events or new safety signals were identified with long-term maintenance therapy.
Comparison of Xpert MTB/RIF with Other Nucleic Acid Technologies for Diagnosing Pulmonary Tuberculosis in a High HIV Prevalence Setting: A Prospective Study

The Xpert MTB/RIF (Cepheid) non-laboratory-based molecular assay has potential to improve the diagnosis of tuberculosis (TB), especially in HIV-infected populations, through increased sensitivity, reduced turnaround time (2 h), and immediate identification of rifampicin (RIF) resistance. In a prospective clinical validation study we compared the performance of Xpert MTB/RIF, MTBDRplus (Hain Lifescience), LightCycler Mycobacterium Detection (LCTB) (Roche), with acid fast bacilli (AFB) smear microscopy and liquid culture on a single sputum specimen.



Consecutive adults with suspected TB attending a primary health care clinic in Johannesburg, South Africa, were prospectively enrolled and evaluated for TB according to the guidelines of the National TB Control Programme, including assessment for smear-negative TB by chest X-ray, clinical evaluation, and HIV testing. A single sputum sample underwent routine decontamination, AFB smear microscopy, liquid culture, and phenotypic drug susceptibility testing. Residual sample was batched for molecular testing. For the 311 participants, the HIV prevalence was 70% (n = 215), with 120 (38.5%) culture-positive TB cases. Compared to liquid culture, the sensitivities of all the test methodologies, determined with a limited and potentially underpowered sample size (n = 177), were 59% (47%-71%) for smear microscopy, 76% (64%-85%) for MTBDRplus, 76% (64%-85%) for LCTB, and 86% (76%-93%) for Xpert MTB/RIF, with specificities all >97%. Among HIV+ individuals, the sensitivity of the Xpert MTB/RIF test was 84% (69%-93%), while the other molecular tests had sensitivities reduced by 6%. TB detection among smear-negative, culture-positive samples was 28% (5/18) for MTBDRplus, 22% (4/18) for LCTB, and 61% (11/18) for Xpert MTB/RIF. A few (n = 5) RIF-resistant cases were detected using the phenotypic drug susceptibility testing methodology. Xpert MTB/RIF detected four of these five cases (fifth case not tested) and two additional phenotypically sensitive cases.



The Xpert MTB/RIF test has superior performance for rapid diagnosis of Mycobacterium tuberculosis over existing AFB smear microscopy and other molecular methodologies in an HIV- and TB-endemic region. Its place in the clinical diagnostic algorithm in national health programs needs exploration. Please see later in the article for the Editors' Summary.
Dyspepsia and gastric emptying in end-stage renal disease patients on hemodialysis

Dyspepsia is common among end-stage renal disease (ESRD) patients and its association with delayed gastric emptying is not well established. We assessed the association of dyspepsia with gastric emptying time in ESRD patients undergoing hemodialysis (HD).



Dyspepsia was assessed through the Porto Alegre Dyspeptic Symptoms Questionnaire (PADYQ). PADYQ's scores ≥ 6 classified participants as dyspeptic. The octanoic acid breath test using ¹³carbon was employed to assess the gastric emptying time. Based on the test, time in minutes to metabolize the first half of the ¹³carbon in the test meal (t1/2) was calculated. Association of dyspepsia with gastric emptying time was tested by the correlation between PADYQ scores and t1/2, and also by comparing t1/2 between dyspeptics and non-dyspeptics.



There were 34 (68.0%) dyspeptic patients. Dyspepsia score was positively correlated with t1/2 (r = 0.366; p = 0.009). Dyspeptics had longer t1/2 compared to non-dyspeptics, respectively, 238.0 ± 92.9 versus 185.5 ± 45.5 minutes (p = 0.042).



Delayed gastric emptying was associated with dyspepsia. Prokinetic medications could have a role in preventing or relieving dyspeptic symptoms among HD patients. Future research in larger samples is necessary to confirm this association.
Eicosapentanoic acid reduces plasma levels of remnant lipoproteins and prevents in vivo peroxidation of LDL in dialysis patients.

Causative factors of uremia-associated atherosclerosis are complex. However, it is likely that atherogenic lipoproteins accumulated in plasma are involved. Remnant lipoproteins are atherogenic and are frequently observed in uremic plasma. LDL from uremic patients has been shown to be susceptible to in vitro peroxidation, suggesting that oxidized LDL (ox-LDL) could be excessively generated in those patients. No effective treatments to prevent accumulation of both atherogenic lipoproteins in dialysis patients have been published. Eicosapentanoic acid (EPA) may change synthesis and/or catabolism of remnant lipoproteins and increase stability of LDL to peroxidation by altering the fatty acid composition of lipoproteins. A prospective comparative study was conducted to assess the efficacy of EPA on metabolism of remnant lipoproteins and ox-LDL in dialysis patients using two new methods: an immunoaffinity gel separation for quantifying plasma remnant lipoproteins and an enzyme-linked immunosorbent assay for measuring plasma ox-LDL levels, a marker for in vivo LDL peroxidation. Twenty-two hemodialysis and 16 continuous ambulatory peritoneal dialysis patients with relatively high plasma levels of remnant lipoproteins and ox-LDL were randomized to either EPA or placebo. Highly purified EPA, in an ethyl-ester form (ethyl all-cis-5,8,11,14,17-icosapentanoate) with a purity greater than 91%, was administered at a dose of 1800 mg daily. Overall, 3 mo of treatment with EPA significantly reduced the levels of both remnant lipoproteins (52% reduction) and ox-LDL (38% reduction). Additionally, gel filtration chromatography of lipoproteins showed that EPA treatment concomitantly normalized other potential abnormalities in lipoproteins. Treatment compliance was good and no critical adverse effects were observed. In conclusion, EPA administration proved to be effective and safe treatment to decrease plasma remnant lipoproteins and prevent in vivo peroxidation of LDL in dialysis patients.