nils-herrmann/clean_scirepeval huggingface dataset:
High-intensity endurance training improves adiponectin mRNA and plasma concentrations

Adiponectin is an anti-inflammatory protein that reduced in obesity. Exercise training may reduce the adipose tissue (AT), although it is not well known whether exercise-induced change in AT, increases the adiponectin mRNA expression and plasma concentrations or not; therefore, the purpose of this study was to investigate the adiponectin mRNA and plasma concentrations in middle-aged men after 12 weeks high-intensity exercise training and after a week detraining. Sixteen sedentary overweight and obese middle-aged men (age 41.18 ± 6.1 years; ± SD) volunteered to participate in this study. The subjects were randomly assigned to training group (n = 8) or control group (n = 8). The training group performed endurance training 4 days a week for 12 weeks at an intensity corresponding to 75–80% individual maximum oxygen consumption for 45 min. After 12 weeks of training, subjects underwent a week of detraining. The results showed that the BMI as well as central and peripheral AT volume were decreased in the training group compared to the control group (P < 0.05). After 12 weeks, the training group resulted in a significant increase (P < 0.05) in the adiponectin gene expression in abdominal and gluteal subcutaneous AT when compared with the control group. The results showed that plasma adiponectin concentrations increased and insulin resistance decreased after training compared to the control group (P < 0.05). After a week of detraining, the variables were not changed significantly in the training group. In conclusion, high-intensity endurance training caused an increase adiponectin mRNA in obese middle-aged men.
Effect of spinal manipulation on sensorimotor functions in back pain patients: study protocol for a randomised controlled trial

Low back pain (LBP) is a recognized public health problem, impacting up to 80% of US adults at some point in their lives. Patients with LBP are utilizing integrative health care such as spinal manipulation (SM). SM is the therapeutic application of a load to specific body tissues or structures and can be divided into two broad categories: SM with a high-velocity low-amplitude load, or an impulse "thrust", (HVLA-SM) and SM with a low-velocity variable-amplitude load (LVVA-SM). There is evidence that sensorimotor function in people with LBP is altered. This study evaluates the sensorimotor function in the lumbopelvic region, as measured by postural sway, response to sudden load and repositioning accuracy, following SM to the lumbar and pelvic region when compared to a sham treatment.



A total of 219 participants with acute, subacute or chronic low back pain are being recruited from the Quad Cities area located in Iowa and Illinois. They are allocated through a minimization algorithm in a 1:1:1 ratio to receive either 13 HVLA-SM treatments over 6 weeks, 13 LVVA-SM treatments over 6 weeks or 2 weeks of a sham treatment followed by 4 weeks of full spine "doctor's choice" SM. Sensorimotor function tests are performed before and immediately after treatment at baseline, week 2 and week 6. Self-report outcome assessments are also collected. The primary aims of this study are to 1) determine immediate pre to post changes in sensorimotor function as measured by postural sway following delivery of a single HVLA-SM or LVVA-SM treatment when compared to a sham treatment and 2) to determine changes from baseline to 2 weeks (4 treatments) of HVLA-SM or LVVA-SM compared to a sham treatment. Secondary aims include changes in response to sudden loads and lumbar repositioning accuracy at these endpoints, estimating sensorimotor function in the SM groups after 6 weeks of treatment, and exploring if changes in sensorimotor function are associated with changes in self-report outcome assessments.



This study may provide clues to the sensorimotor mechanisms that explain observed functional deficits associated with LBP, as well as the mechanism of action of SM.


 The first participant was allocated on 30 January 2009 and the final participant was allocated on 17 March 2011.
Orthotic insoles do not prevent physical stress-induced low back pain

Orthotic insoles are suggested to prevent low back pain. This randomized controlled study assessed if customised orthotic insoles prevent low back pain. Healthy military conscripts (n = 228; mean age 19 years, range 18–29) were randomly assigned to use either customised orthotic insoles (treatment group, n = 73) or nothing (control group, n = 147). The main outcome measure was low back pain requiring a physician visit and resulting in minimum 1 day suspension from military duty. Twenty-four (33%) treated subjects and 42 (27%) control subjects were suspended from duty due to low back pain (p = 0.37; risk difference 4.3%; 95% CI: −8.7 to 17.3%). Mean suspension duration was 2 days (range 1–7) in both groups. Four (5%) treated subjects and eight (5%) control subjects were released from duty due to persistent low back pain (p = 0.92; risk difference 0%; 95% CI: −6 to 6%). Use of orthotic insoles is therefore not recommended to prevent physical stress-related low back pain.
Preemptive oral rofecoxib plus postoperative intraarticular bupivacaine for pain relief after arthroscopic knee surgery.

This study was designed to test the hypothesis whether preemptive administration of rofecoxib, a novel selective COX-2 inhibitor, can prolong intraarticular bupivacaine analgesia after arthroscopic knee surgery. Sixty-two patients were randomly assigned to one of the three groups. Group 1 (n=21) was administered oral rofecoxib 50 mg 1 h before surgery plus intraarticular 0.5 % bupivacaine 20 ml postoperatively. Group 2 (n=21) was administered the same dose of bupivacaine. Group 3 (n=20) was administered saline 20 ml intraarticularly after surgery. Pain scores (VAS) were assessed at 30 min, 1, 2, 4, 6, 12 and 24 h postoperatively. Analgesia duration, analgesic (tramadol and tenoxicam) requirements, and adverse effects were recorded postoperatively for 24 h. Pain scores were significantly lower in the Group 1 at all time points (p<0.05, p<0.001) and were significantly lower in the Group 2 at 30 min (p<0.001), 1 and 4 h (p<0.05) compared to the Group 3. Pain scores were significantly lower in the Group 1 compared to the Group 2 during the first 4 h after surgery (p<0.05, p<0.001). Analgesia duration was longer in Group 1 than Group 2 or 3 (743.0 +/- 480.5 min versus 262.4 +/- 292.2 min and 17.0 +/- 12.1 min; p<0.05, p<0.001 respectively), and in Group 2 than Group 3 (p<0.05). Tramadol requirements were significantly less in Group 1 than Group 2 and 3 (4.8 +/- 15.0 mg versus 40.5 +/- 43.6 mg and 67.5 +/- 24.5 mg; p<0.05, p<0.001 respectively), and in Group 2 than Group 3 (p<0.05). There were no significant differences among the groups regarding the tenoxicam requirements and adverse effects. In conclusion, the combination of oral rofecoxib administered preemptively and intraarticular bupivacaine administered postoperatively provided a significant analgesic benefit and decreased the opioid requirements after arthroscopic knee surgery, when compared to bupivacaine alone or saline.
Randomized study of mammography screening — preliminary report on mortality in the stockholm trial

In March 1981, 40,318 women in Stockholm, aged 40–64, entered a randomized trial of breast cancer screening by single-view mammography alone versus no intervention in a control group of 20,000 women. The attendance rate during the first screening round was 81 per cent and the cancer detection rate was 4.0 per 1000 women. The detection the rate fell to 3.1 per 1000 in the second round, which was completed in October 1985. During 1986 the controlled design of the study was broken and the contro women were invited once to screening which was completed the same year. A total of 428 cases of breast cancer were thus diagnosed in the study group and 439 in the adjusted control group. After a mean follow-up of 7.4 years the number of breast cancer deaths in the study and control groups was 39 and 30 respectively. The relative risk of breast cancer death (screening versus control) was 0.71 (95 per cent confidence interval: 0.4–1.2). Among women older than 50 years at entry the relative risk was 0.57 (95 per cent confidence interval: 0.3–1.1). Cancer deaths among women under 50 were few and perhaps because of this no mortality reduction was seen in this age group. The estimate of mortality reduction lies between the results from two earlier Swedish randomized controlled trials.
The use of Monte Carlo methods in natural resource management models

The Monte Carlo method provides a means of introducing natural variability in data, uncertainty of parameter estimation, chance occurrences and model reliability, into the process of simulation modeling for resource management. The technique is described and demonstrated for a hypothetical application of a Gaussian Plume Dispersion Model to a case of atmospheric pollution. It is concluded that the utility of the Monte Carlo approach lies mainly in providing decision makers with information on the likelihood of extreme occurrences and the inherent reliability of simulation modeling.
A Randomized , Double-Blinded , Placebo-Controlled Phase II Trial of Recombinant Human Leukemia Inhibitory Factor ( rhuLIF , Emfilermin , AM 424 ) to Prevent Chemotherapy-Induced Peripheral Neuropathy

To determine whether recombinant human leukemia inhibitory factor (rhuLIF, AM424, emfilermin) can prevent or ameliorate the development of chemotherapyinduced peripheral neuropathy (CIPN) after treatment with carboplatin (AUC 6) and paclitaxel (175 mg/m over 3 hours).  Randomized double-blind placebo-controlled phase II clinical trial. Eligible patients had solid tumors for which treatment with carboplatin/paclitaxel was appropriate. The primary end point was a standardized composite peripheral nerve electrophysiology (CPNE) score, based on nerve velocities and amplitudes, measured at baseline and after four cycles of chemotherapy. Secondary efficacy end points included CPNE score at last cycle and at exit evaluation, vibration perception threshold, H-reflex latency, symptom scores, and quantitative assessment of neurologic signs. Study drug was given s.c. daily for 7 days starting the day before chemotherapy. Patients were randomized to receive low-dose rhuLIF (2 Mg/kg), high-dose rhuLIF (4 Mg/kg), or placebo.  Patients (n = 117) were randomized across seven neurology test centers. Thirty-six patients received low dose rhuLIF (2 Mg/kg), 39 received high dose rhuLIF (4 Mg/kg) and 42 received placebo. rhuLIF was well tolerated with 95% compliance and no adverse effects on quality of life. No differences between groups in CPNE or any of the individual neurologic testing variables were observed between baseline and cycle 4 or by the secondary
Lack of efficacy of the selective iNOS inhibitor GW274150 in prophylaxis of migraine headache.

This study investigated the efficacy and tolerability of the highly selective iNOS inhibitor GW274150 in prophylaxis of migraine headache.



The study was conducted in two parts, each comprising a 4-week baseline period, a 12-week, double-blind, parallel-group treatment period, and a 4-week follow-up period. The study had an adaptive design in that findings of Part 1 of the study were used to inform the conduct of Part 2. Following an interim analysis at the end of Part 1, the trial could be stopped for futility or continued in Part 2 to study the full-dose response or to increase sample size in case initial assumptions had been violated. The primary end-point in both parts of the study was the probability of the occurrence of a migraine headache day during the baseline period and the treatment period.



In Part 1, adult male and female patients with migraine received GW274150 60 mg (n = 37), 120 mg (n = 37), or placebo (n = 38) once daily for 12 weeks. In Part 2, female patients with migraine received GW274150 60 mg (n= 160) or placebo (n = 154) once daily for 12 weeks. GW274150 was no more effective than placebo for the primary efficacy end-point or any secondary efficacy end-point in Part 1 or Part 2. GW274150 was generally well tolerated.



GW274150 at doses predicted to inhibit iNOS >80% did not differ from placebo in the prophylaxis of migraine. The results do not support a role of iNOS inhibition in migraine prevention.
Remote Ischemic Conditioning Reduces Myocardial Infarct Size in STEMI Patients Treated by Thrombolysis.

In many developing nations, where primary percutaneous coronary intervention (PPCI) is not widely available, ST-segment elevation myocardial infarction (STEMI) patients are still treated by thrombolysis (1). However, because thrombolytic therapy is less effective than PPCI at restoring blood flow in an infarct-related coronary artery, thrombolyzed STEMI patients experience larger myocardial infarcts and are
Randomized Trial Comparing Off-Pump to On-Pump Coronary Artery Bypass Grafting in High-Risk Patients ( # 2003-13903

The subset of patients most likely to benefit from off-pump coronary artery bypass grafting (CABG) remains a controversial issue, but the technique has been proposed to decrease postoperative mortality and morbidity. The objective of this study was to compare off-pump to on-pump CABG in patients with known risk factors for mortality and morbidity. 65 high-risk patients were prospectively randomized to undergo off-pump or on-pump CABG. Recruited patients had at least 3 of the following criteria: age greater than 65 years, high blood pressure, diabetes, serum creatinine greater than 133 ␮mol/L, left ventricular ejection fraction lower than 45%, chronic pulmonary disease, unstable angina, congestive heart failure, repeat CABG, anemia, and carotid atherosclerosis. Hospital mortality and morbidity were the primary end-points of the study.  Six patients (9%) crossed over from the original randomized group. Twenty-eight patients averaging 70 ± 8 years of age underwent 3 ± 1 grafts off pump, and 37 patients averaging 70 ± 6 years of age underwent 3.4 ± 1 grafts on pump. Revascularization was considered complete in 21 (75%) of off-pump patients compared to 33 (89%) of on-pump patients (P = .1). There were no hospital deaths in off-pump patients, and 2 patients (5%) undergoing on-pump CABG died early following surgery (P = .2). Two off-pump (7%) compared to 11 on-pump (30%) of patients presented composite end-points including death, neurolog-ical injury, renal failure, respiratory failure, and operative myocardial infarction after CABG (P = .02).  The present study suggests that off-pump CABG, when technically feasible, significantly reduces morbidity following surgery in a group of high-risk patients. Coronary artery bypass grafting (CABG) is currently performed with or without the use of the cardiopulmonary bypass system (CPB). Although both techniques are being used with success [Van Dijk 2001], a debate is raging between advocates and opponents of off-pump CABG about patient outcomes and surgical indications for one or the other technique [Bonchek 2002]. Several authors have suggested that off-pump CABG could be especially useful and effective in improving clinical outcomes in high-risk patients who require surgical revascu-larization [Hoff 2002, Al-Ruzzeh 2003]. Elderly patients and those with significant comorbidities are more susceptible to the deleterious effects of CPB and are most likely to benefit from the use of off-pump CABG compared to the standard on-pump approach  The objective of the present study was to compare outcomes between off-pump CABG and a standard technique of CABG with …
Treatment of fibromyalgia at the Maharishi Ayurveda Health Centre in Norway II—a 24-month follow-up pilot study

Treatments offered at the Maharishi Ayurveda Health Centre in Norway are based on Maharishi Vedic Medicine (MVM). MVM is a consciousness-based revival by Maharishi Mahesh Yogi, the founder of the Transcendental Meditation (TM) program of the ancient Ayurvedic medicine tradition in India. To extend from 6 to 24 months, a pilot study of the effects of the treatment program at the Health Centre on fibromyalgia. Retesting 2 years after a clinical trial. In this intention to treat study, 31 women with a diagnosis of fibromyalgia received an individually tailored program of (1) physiological purification therapy (Maharishi Panchakarma) and (2) Ayurvedic recommendations regarding daily routine and diet including a novel approach to food intolerance. Five subjects chose to learn TM for stress reduction, pain management and personal development. All were recommended Ayurvedic herbal products for follow-up treatment. A modified Fibromyalgia Impact Questionnaire (FIQ) that included seven dimensions. Scores at 24 months follow-up were compared with pre-treatment scores. At 24-months follow-up, there were significant reductions (26% to 44%) in six of the seven fibromyalgia dimensions: impairment of working ability, pain, tiredness, morning tiredness, stiffness and anxiety. The 7th, depression, decreased 32% (borderline significant). At 24 months, the four subjects who continued practising TM, had almost no symptoms and significantly lower FIQ change scores (−92% to 97%) than the non-meditators on all outcomes. This pilot study suggests that the treatments and health promotion programs offered at the Maharishi Ayurveda Health Centre in Norway lead to long-term reductions in symptoms of fibromyalgia, which is considered a treatment-resistant condition, and further studies are warranted.
Effects of a polyelectrolyte additive on the selective dialysis membrane permeability for low-molecular-weight proteins.

Improving the sieving characteristics of dialysis membranes enhances the clearance of low-molecular-weight (LMW) proteins and may have an impact on outcome in patients receiving haemodialysis. To approach this goal, a novel polyelectrolyte additive process was applied to a polyethersulphone (PES) membrane.



Polyelectrolyte-modified PES was characterized in vitro by measuring complement activation and sieving coefficients of cytochrome c and serum albumin. In a prospective, randomized, cross-over study, instantaneous plasma water clearances and reduction rates of LMW proteins [beta(2)-microglobulin (b2m), cystatin c, myoglobin, retinol binding protein] were determined in eight patients receiving dialysis treatment with PES in comparison with polysulphone (PSU). Biocompatibility was assessed by determination of transient leucopenia, plasma levels of complement C5a, thrombin-antithrombin III (TAT), myeloperoxidase (MPO) and elastase (ELT).



PES showed a steeper sieving profile and lower complement activation in vitro compared with PSU. Instantaneous clearance (69 +/- 8 vs. 58 +/- 3 ml/min; P < 0.001) and reduction rate (72.3 +/- 1 5% vs 66.2 +/- 6.1%; P < 0.001) of b2m were significantly higher with PES as compared with PSU. With higher molecular weight of proteins, differences in the solute removal between PES and PSU further increased, whereas albumin loss remained low (PES, 0.53 +/- 0.17 vs PSU, <0.22 g/dialysis). MPO, ELT and TAT did not differ between the two membranes. In contrast, leucopenia was less pronounced and C5a generation was significantly lower during dialysis with PES.



Polyelectrolyte modification of PES results in a higher LMW protein removal and in optimized biocompatibility. Whether these findings translate into better outcome of patients receiving haemodialysis requires further studies.
Randomised study versus control group of customised therapeutic education for patients in follow-up for rheumatoid arthritis.

We have evaluated customized objectives, predefined during a therapeutic education session for rheumatoid arthritis (RA).



Fifty-four RA patients were randomised into patient therapeutic education (PTE) group versus waiting list (WL). The final comparative evaluation involved solving 3 predefined problems.



Fifty-four were evaluated after 6 months. The main criterion was defined for all three of the chosen themes at 76.9% in the PTE group and 42.4% in the WL group. Among the other positively evaluated criteria were: less corticotherapy, more occupational therapy, more demand for social aid, more physical activity, knowledge of the recognition of an RA attack and how to cope with it. On the other hand, knowledge of the treatments did not differ between the 2 groups nor did the RAPID scores, fatigue, stiffness, depression, compliance, number of consultations and hospitalisations. Patient satisfaction was excellent (between 85.3 and 93.9%).



This study is a good illustration of the position occupied and value of PTE in solving the problems specific to each RA case, the resulting high level of patient satisfaction and its independently complementary aspects relative to the purely medical treatment of RA. Customized PTE could better respond to specific patients problems in RA.
Long-term outcomes for HIV-infected infants less than 6 months of age at initiation of lopinavir/ritonavir combination antiretroviral therapy.

To investigate the longitudinal pharmacokinetics, safety and efficacy of lopinavir/ritonavir (LPV/r) in HIV-infected infants initiating combination antiretroviral therapy (cART) between 2 weeks and 6 months of age.



A prospective, open-label, multicenter Phase I/II study of LPV/r-based cART at a dose of 300/75 mg/m(2)/dose LPV/r twice daily. Intensive pharmacokinetic sampling at 12 months of age and quarterly predose LPV concentrations were collected and safety, virologic and immunologic responses were monitored every 4-12 weeks up to 252 weeks.



Thirty-one HIV-infected infants enrolled into two age cohorts, 14 days to <6 weeks and 6 weeks to <6 months; 29 completed ≥48 weeks of follow-up (median = 123 weeks, range 4-252). At 12 months of age, median LPV area under the curve was comparable for both age cohorts and similar to older children and adults. At week 48, 22 of 31 patients (71%) had HIV-1 RNA <400 copies/ml and 11 of 15 (73%) had <50 copies/ml; 29 of 31 achieved HIV-1 RNA <400 copies/ml on study treatment and 19 (66%) remained durably suppressed until the end of study; viral suppression correlated with a higher percentage of predose time points exceeding the LPV target of 1 μg/ml (92 vs. 71%, P = 0.002).



LPV/r at 300/75 mg/m(2)/dose as part of a cART regimen resulted in viral suppression through 96 weeks of treatment in >65% of young infants. Due to initially low LPV exposure in infants <6 weeks of age, frequent dose adjustment for weight gain is advisable and consideration should be given to studying a higher dose for very young infants.