nils-herrmann/clean_scirepeval huggingface dataset:
Effectiveness of Home-Based Cupping Massage Compared to Progressive Muscle Relaxation in Patients with Chronic Neck Pain—A Randomized Controlled Trial

Chronic neck pain is a major public health problem with very few evidence-based complementary treatment options. This study aimed to test the efficacy of 12 weeks of a partner-delivered home-based cupping massage, compared to the same period of progressive muscle relaxation in patients with chronic non-specific neck pain. Patients were randomly assigned to self-directed cupping massage or progressive muscle relaxation. They were trained and asked to undertake the assigned treatment twice weekly for 12 weeks. Primary outcome measure was the current neck pain intensity (0-100 mm visual analog scale; VAS) after 12 weeks. Secondary outcome measures included pain on motion, affective pain perception, functional disability, psychological distress, wellbeing, health-related quality of life, pressure pain thresholds and adverse events. Sixty one patients (54.1±12.7 years; 73.8%female) were randomized to cupping massage (n = 30) or progressive muscle relaxation (n = 31). After treatment, both groups showed significantly less pain compared to baseline however without significant group differences. Significant effects in favor of cupping massage were only found for wellbeing and pressure pain thresholds. In conclusion, cupping massage is no more effective than progressive muscle relaxation in reducing chronic non-specific neck pain. Both therapies can be easily used at home and can reduce pain to a minimal clinically relevant extent. Cupping massage may however be better than PMR in improving well-being and decreasing pressure pain sensitivity but more studies with larger samples and longer follow-up periods are needed to confirm these results.
Effect of atorvastatin on pancreatic Beta-cell function and insulin resistance in type 2 diabetes mellitus patients: a randomized pilot study.

Statins are commonly used for the management of dyslipidemia in type 2 diabetes mellitus patients. We hypothesized that atorvastatin could modulate the beta-cell function by altering the levels of proapoptotic and antiapoptotic lipoproteins and could also have an effect on insulin resistance. The aim of the present pilot study was to assess the effect of atorvastatin 10 mg on pancreatic beta-cell function and insulin resistance in patients with hyperlipidemia and type 2 diabetes by using the homeostasis model assessment-2 (HOMA2) index.



Fifty-one type 2 diabetes patients receiving oral antidiabetes drugs, not taking statins, with baseline low-density lipoprotein cholesterol between 2.6 mmol/L and 4.1 mmol/L were included. Forty-three patients (21 in placebo group and 22 in atorvastatin group) completed the study and were taken up for final analysis. Fasting blood samples were obtained at baseline and at 12 weeks to determine levels of blood glucose, lipid profile, insulin, C-peptide and glycosylated hemoglobin (A1C).



Atorvastatin nonsignificantly increased fasting serum insulin (+14.29%, p=0.18), accompanied by marginal nonsignificant increases in fasting plasma glucose and A1C. There was a decrease in HOMA2 percent beta-cell function (-2.9%, p=0.72) and increase in HOMA2 insulin resistance (+14%, p=0.16) in the atorvastatin group as compared with baseline, but the difference was not statistically significant.



Atorvastatin in the dose used failed to produce significant change in pancreatic beta-cell function and insulin resistance in type 2 diabetes patients as assessed by the HOMA2 index. The possible explanations include absence of lipotoxicity at prevailing levels of dyslipidemia at baseline or inadequacy of statin dose used in the study.
Trial participation disclosure and gel use behavior in the CAPRISA 004 tenofovir gel trial

Disclosure, or open communication, by female microbicide trial participants of their trial participation and use of an investigational HIV prevention drug to a sexual partner may affect participants' trial product usage behavior and contribute to poor adherence. With mixed results from recent microbicide clinical trials being linked to differing participant adherence, insights into the communication dynamics between trial participants and their sexual partners are particularly important. We examined the quantitative association between (1) communication of trial participation to a partner and participant adherence to gel and (2) communication of trial participation to a partner and participant HIV status. An in-depth adherence and product acceptability assessment was administered to the women participating in the CAPRISA 004 trial. Additionally, we collected qualitative data related to communication of trial participation and gel use. Qualitatively, among 165 women who had reported that they had discussed trial participation with others, most (68%) stated that they communicated participation to their sexual partner. Most of the women who had communicated study participation with their partners had received a positive/neutral response from their partner. Some of these women stated that gel use was easy; only a small number said that gel use was difficult. Among women who did not communicate their study participation to their partners, difficulty with gel use was more common and some women stated that they feared communicating their participation. Quantitatively, there was no statistically significant difference in the proportions of women who had communicated study participation to a partner across different adherence levels or HIV status. A deeper knowledge of the dynamics surrounding trial participation communication to male partners will be critical to understanding the spectrum of trial product usage behavior, and ultimately to designing tailored strategies to assist trial participants with product adherence.
P02.176. Acupuncture for symptom management in hemodialysis patients: a prospective, observational pilot study

Patients undergoing hemodialysis suffer from a variety of complications related to end-stage renal disease. This prospective, observational pilot study aims to determine the feasibility, safety, and possible benefits of acupuncture for symptom management in patients undergoing hemodialysis.



Twenty-four (24) patients undergoing hemodialysis received acupuncture treatment for their symptoms. Manually stimulated, individualized acupuncture treatments were provided twice a week for 6 consecutive weeks on a nondialysis day or on the day of hemodialysis prior to initiating treatment. Symptoms were evaluated using the Measure Your Medical Outcome Profiles 2 questionnaire, and quality of life was measured by Kidney Disease Quality of Life-Short Form (KDQOL-SF(™)) Version 1.3 at baseline, 7 weeks and 11 weeks from baseline. Statistical analysis was conducted on the basis of the intention-to-treat principle.



Twenty-one (21) patients (87%) completed the whole treatment course and follow-up evaluation. Three (3) patients dropped out due to increased fatigue (n = 1), pancreatic and renal transplantation (n = 1), and infections of the arteriovenous fistula used for hemodialysis access (n = 1). Patients experienced a significant improvement of symptoms considered the most bothersome, reporting a decrease of 1.87 and 2.08 points on a 0-6 symptom scale at 7 weeks and 11 weeks, respectively (both p < 0.0001). Some subscales of KDQOL-SF(™) showed significant improvement at 7 weeks (effects of kidney disease, burden of kidney disease, role-limitations physical, emotional well-being, and energy/fatigue) and 11 weeks (physical functioning and energy/fatigue). No serious adverse events related to acupuncture occurred.



Acupuncture seems feasible and safe for symptom management in patients undergoing hemodialysis. Future controlled trials are needed to confirm the benefits of acupuncture.
Enalapril versus atenolol in the treatment of hypertensive smokers

A randomised crossover study has been done to compare the antihypertensive efficacy of enalapril and atenolol in 45 smoking, hypertensive men. Treatment was started with enalapril 20 mg/d or atenolol 50 mg/d and, if necessary, the doses were doubled after 4 weeks to achieve a sitting diastolic blood pressure ≤ 95 mm Hg, after which hydrochlorothiazide was added, if necessary. Both drugs lowered blood pressure significantly. However, enalapril was more efficient in lowering both systolic and diastolic blood pressure; the mean difference was significant after both 4 and 8 weeks in the sitting systolic (11.6 mm Hg and 7.9 mm Hg) and diastolic (3.3 mm Hg and 3.0 mm Hg) pressures and in the erect systolic pressures (8.2 mm Hg and 7.2 mm Hg), and after 8 weeks in the supine systolic pressure, too (8.9 mm Hg). The effect on enalapril was especially marked in moderate (<20 cigarettes/day) smokers. The need for diuretics was also significantly less in the enalapril group. It appears that angiotensin-converting enzyme inhibitors may be superior to β-adrenoceptor blockers in the treatment of hypertensive smoking patients.
Three-dimensional susceptibility-weighted imaging and two-dimensional T2*-weighted gradient-echo imaging of intratumoral hemorrhages in pediatric diffuse intrinsic pontine glioma

We compared the sensitivity and specificity of T2*-weighted gradient-echo imaging (T2*-GRE) and susceptibility-weighted imaging (SWI) in determining prevalence and cumulative incidence of intratumoral hemorrhages in children with diffuse intrinsic pontine glioma (DIPG) undergoing antiangiogenic and radiation therapy. Patients were recruited from an institutional review board-approved prospective phase I trial of vandetanib administered in combination with radiation therapy. Patient consent was obtained before enrollment. Consecutive T2*-GRE and SWI exams of 17 patients (F/M: 9/8; age 3–17 years) were evaluated. Two reviewers (R1 and R2) determined the number and size of hemorrhages at baseline and multiple follow-ups (92 scans, mean 5.4/patient). Statistical analyses were performed using descriptive statistics, graphical tools, and mixed-effects Poisson regression models. Prevalence of hemorrhages at diagnosis was 41% and 47%; the cumulative incidences of hemorrhages at 6 months by T2*-GRE and SWI were 82% and 88%, respectively. Hemorrhages were mostly petechial; 9.7% of lesions on T2*-GRE and 5.2% on SWI were hematomas (>5 mm). SWI identified significantly more hemorrhages than T2*-GRE did. Lesions were missed or misinterpreted in 36/39 (R1/R2) scans by T2*-GRE and 9/3 scans (R1/R2) by SWI. Hemorrhages had no clinically significant neurological correlates in patients. SWI is more sensitive than T2*-GRE in detecting hemorrhages and differentiating them from calcification, necrosis, and artifacts. Also, petechial hemorrhages are more common in DIPG at diagnosis than previously believed and their number increases during the course of treatment; hematomas are rare.
American ginseng (Panax quinquefolius) administration does not affect performance of the Roche COBAS Ampliprep/Taqman HIV-1 RNA assay

Previous data indicate that purified components of ginseng can inhibit HIV reverse transcriptase in vitro, suggesting that ginseng components in plasma may interfere with HIV-1 RNA detection assays.



Pre- and post-dose plasma from three volunteers dosed with 3000 mg American ginseng was spiked with HIV and analyzed by the Roche COBAS Ampliprep/Taqman v2.0 HIV-1 RNA assay.



Presence of American ginseng had no significant effect on measured HIV-1 RNA concentration. Variation within pre- and post-dose plasma pair was insignificant and within assay performance limits.



Plasma from subjects dosed with 3000 mg American ginseng does not interfere with the Roche COBAS Ampliprep/Taqman v2.0 HIV-1 RNA assay. This implies that in vitro inhibition of HIV reverse transcriptase by American ginseng components is unlikely to be clinically relevant.
A phase II trial of liposomal busulphan as an intravenous myeloablative agent prior to stem cell transplantation: 500 mg/m2 as a optimal total dose for conditioning

We conducted a phase I/II trial, to evaluate the efficacy and safety of an intravenous liposomal formulation of busulphan (LBu) as a myeloablative agent for stem cell transplantation (SCT). The liposomal busulphan was administered as a 3 h infusion twice daily over 4 consecutive days. Six adults received 1.6–2 mg/kg/dose and 18 children received 1.8–3 mg/kg/dose. Pharmacokinetic parameters were studied after the first and the last dose of busulphan. No significant difference in clearance, AUC, elimination half-lives or distribution volume between the first and the last dose was found in either groups. A significantly (P < 0.005) higher clearance was observed in children after the first and the last dose (3.61 and 3.79 ml/min/kg, respectively) compared to adults (2.40 and 2.33 ml/min/kg, respectively). The elimination half-lives after the first and the last dose were significantly (P < 0.005) shorter in children (2.59 and 2.72 h, respectively) compared to adults (3.35 and 3.61 h, respectively). Clearance correlated significantly with age. However, no significant correlation with age was observed when clearance was adjusted to the body surface area. Two cases of VOD following a total dose of 24 mg/kg were observed. Six patients experienced mucositis. No other organ toxicity was observed. We conclude that intravenous liposomal busulphan pharmacokinetics is age dependent. A dosage schedule based on body surface area should be used especially in young children to reduce the age-dependent difference in kinetics. An intravenous liposomal dose of busulphan of 500 mg/m2 is suggested to reach a similar systemic exposure and myeloablative effect in both children and adults. Moreover, the novel liposomal form of busulphan showed a favorable toxicity profile and seems safe as a part of the high-dose therapy prior to SCT.
A prospective observational study of treatment practice patterns in acute coronary syndrome patients undergoing percutaneous coronary intervention in Europe.

The AntiPlatelet Therapy Observational Registry (APTOR) was a prospective observational study of acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) in France, Spain, and the UK.



To evaluate patterns of ACS healthcare use, focusing on APTOR results from France.



Consecutive presenting ACS patients requiring PCI were recruited between January and August 2007. Treatments and outcomes were recorded from the qualifying ACS event to 12 months follow-up.



In France, qualifying diagnosis was unstable angina/non-ST-segment elevation myocardial infarction (UA/NSTEMI) in 255(53%) patients and ST-segment elevation myocardial infarction (STEMI) in 228(47%)patients. Ninety-six percent underwent PCI with stent implantation. Drug eluting stents were used less frequently in France(22%) than Spain (54%) or the UK (42%). In France, antiplatelets were more frequently received in the ambulance (21%); a 200-299mg aspirin-loading dose was most frequently received (50%) and more than a third of patients received a clopidogrel-loading dose of over 300mg (34%). At 12 months in France, 86% were still receiving aspirin, 75% clopidogrel, and 73% combination treatment.



There was considerable country-variation in ACS management. These results provide a benchmark of physician practice to compare with guidelines.
Dyadic measures of the parent-child relationship during the transition to adolescence and glycemic control in children with type 1 diabetes.

To identify aspects of family behavior associated with glycemic control in youth with type 1 diabetes mellitus during the transition to adolescence, the authors studied 121 9- to 14-year-olds (M = 12.1 yrs) and their parents, who completed the Diabetes Family Conflict Scale (DFCS) and the Diabetes Family Responsibility Questionnaire (DFRQ). From the DFRQ, the authors derived 2 dyadic variables, frequency of agreement (exact parent and child concurrence about who was responsible for a task) and frequency of discordance (opposite parent and child reports about responsibility). The authors divided the cohort into Younger (n = 57, M = 10.6 yrs) and Older (n = 64, M = 13.5 yrs) groups. Family conflict was significantly related to glycemic control in the entire cohort and in both the Younger and Older groups. However, only in the Younger group was Agreement related to glycemic control, with higher Agreement associated with better glycemic control. Findings suggest that Agreement about sharing of diabetes responsibilities may be an important target for family-based interventions aiming to optimize glycemic control in preteen youth.
The effectiveness and satisfaction of web-based physiotherapy in people with spinal cord injury: a pilot randomised controlled trial

A pilot randomised controlled trial.The aims of this study were to evaluate the effectiveness and participant satisfaction of web-based physiotherapy in people with spinal cord injury (Community patients of a national spinal injury unit in a university teaching hospital, Scotland, Twenty-four participants were recruited and randomised to receive 8 weeks of web-based physiotherapy (intervention), twice per week, or usual care (control). Individual exercise programmes were prescribed based on participants' abilities. The intervention was delivered via a website (www.webbasedphysio.com) and monitored and progressed remotely by the physiotherapist.Participants logged on to the website an average of 1.4±0.8 times per week. Between-group differences, although not significant, were more pronounced for the 6-min walk test. Participants were positive about using web-based physiotherapy and stated that they would be happy to use it again and would recommend it to others. Overall, it was rated as either good or excellent.Web-based physiotherapy was feasible and acceptable for people with SCI. Participants achieved good compliance with the intervention and rated the programme highly and beneficial for health and well-being at various states after injury. The results of this study warrant further work with a more homogeneous sample.This study was funded by the Queen Elizabeth National Spinal Injuries Unit, Glasgow, UK.
Lidocaine patch (5%) is no more potent than placebo in treating chronic back pain when tested in a randomised double blind placebo controlled brain imaging study

The 5% Lidocaine patch is used for treating chronic neuropathic pain conditions such as chronic back pain (CBP), diabetic neuropathy and complex regional pain syndrome, but is effective in a variable proportion of patients. Our lab has reported that this treatment reduces CBP intensity and associated brain activations when tested in an open labelled preliminary study. Notably, effectiveness of the 5% Lidocaine patch has not been tested against placebo for treating CBP. In this study, effectiveness of the 5% Lidocaine patch was compared with placebo in 30 CBP patients in a randomised double-blind study where 15 patients received 5% Lidocaine patches and the remaining patients received placebo patches. Functional MRI was used to identify brain activity for fluctuations of spontaneous pain, at baseline and at two time points after start of treatment (6 hours and 2 weeks).



There was no significant difference between the treatment groups in either pain intensity, sensory and affective qualities of pain or in pain related brain activation at any time point. However, 50% patients in both the Lidocaine and placebo arms reported a greater than 50% decrease in pain suggesting a marked placebo effect. When tested against an untreated CBP group at similar time points, the patch treated subjects showed significantly greater decrease in pain compared to the untreated group (n = 15).



These findings suggest that although the 5% Lidocaine is not better than placebo in its effectiveness for treating pain, the patch itself induces a potent placebo effect in a significant proportion of CBP patients.
Rivermead Assessment of Somatosensory Performance

Sensible Defizite nach einem Schlaganfall sind häufig, sie beeinflussen in negativer Weise die Regeneration motorischer Funktionen, die Unabhängigkeit in den Aktivitäten des täglichen Lebens (ADL), die Länge des stationären Aufenthaltes und letztlich die Lebensqualität. Im deutschen Sprachraum existiert bisher kein reliables, standardisiertes Untersuchungsinstrument. Ziel der Arbeit war die standardisierte Übersetzung und Validierung des Sensibilitätsassessments „Rivermead Assessment of Somatosensory Performance“ (RASP). Die Übersetzung der englischsprachigen Originalversion des RASP erfolgte standardisiert nach dem Protokoll des „Medical Outcomes Trust“. Die Testung der deutschen Version erfolgte an 60 Patienten nach erstmaligem Schlaganfall. Als Maß für die Inter-Rater-Reliabilität der Subtests wurden AC1-Koeffizienten berechnet. Der mittlere AC1-Koeffizient lag bei 0,75 mit einer Spannbreite von 0,583 bis 0,813. Die Übereinstimmung der beiden Rater in allen Subtests war somit gut bis hervorragend. Die deutsche Version des RASP (RASP-DT) stellt ein hervorragendes Messinstrument für sensible Defizite nach einem Schlaganfall dar. Sensory deficits after stroke are common and impact motor regeneration and the total length of hospital stay as well as quality of life factors including the independence to conduct daily life activities. There is currently no existing reliable and standardized assessment tool to measure somatosensory performance in the German language. The aim of our study was to translate the original version of the Rivermead assessment for somatosensory performance (RASP) into German and to study its reliability in a German-speaking population sample. The translation of the English original version followed the protocol of the Medical Outcomes Trust. The German version was assessed with 60 patients with first time presentation of subacute stroke and AC1 coefficients were calculated to measure interrater reliability for the different subtests. The mean AC1 value was 0.75 (range  0.58–0.81). The interrater reliability was good to excellent for all subtests. The German version of the RASP (RASP-DT) developed in this study is a reliable assessment instrument for sensory deficits after stroke.
Recommended dose of arbekacin, an aminoglycoside against methicillin-resistant Staphylococcus aureus, does not achieve desired serum concentration in critically ill patients with lowered creatinine clearance.

To define the pharmacokinetics of arbekacin (ABK), an aminoglycoside, in patients with acutely lowered renal function.



We measured the serum concentrations of ABK, using fluorescence polarization immunoassay, in 10 critically ill patients (patient group) and six healthy volunteers (control group). Data were analysed with a two-compartment model and parameters were estimated by the Bayesian method. The Mann-Whitney U-test or chi-squared test was used as appropriate (P < 0.05).



Creatinine clearance (CCR), measured or estimated using Cockcroft and Gault's formula of the patient group (CCR: 58 +/- 13 mL/min), was significantly lower than that of the control group (CCR: 99 +/- 8 mL/min). However, despite the low CCR, even the maintenance ABK dosage for normal CCR did not elevate the highest serum level (C(max)) to the effective range in the patient group. Although the ABK clearance (CL) did not differ between the groups, the patients' distribution volume (V(d)) increased significantly compared with the control. The transfer rate constant from central to peripheral compartment (k(12)) in the patient group was much higher than that in the control.



In critically ill patients with lowered CCR, the ABK dose for normal CCR subjects does not elevate its serum concentration to effective levels because of augmented V(d) caused by increased k(12). The present results hypothesize that adjustment of antibiotic dosing according to CCR further lowers C(max) in critically ill patients with reduced CCR.