nils-herrmann/clean_scirepeval huggingface dataset:
The effects of baseline heart rate recovery normality and exercise training protocol on heart rate recovery in patients with heart failure

It is unclear which exercise training protocol yields superior heart rate recovery (HRR) improvement in heart failure (HF) patients. Whether baseline HRR normality plays a role in the improvement is unknown. We hypothesized that an exercise training protocol and baseline HRR normality would be factors in altering HRR in HF patients.



In this prospective, randomized, controlled and 3 group parallel study, 41 stable HF patients were randomly assigned to 3-times-weekly training sessions for 12 weeks, consisting of i) 30 minutes of interval training (IT) (n=17, 63.7±8.8 years old) versus ii) 30 minutes of continuous training (CT) (n=13, 59.6±6.8 years old) versus iii) no training (CON) (n=11, 60.6±9.9 years old). Each patient had cardiopulmonary exercise testing before and after the training program. Maximum heart rates attained during the test and heart rates at 1 and 2 min (HRR1 and HRR2) during the recovery phase were recorded. Paired samples t-test or Wilcoxon signed-rank test was used for comparisons before and after training. One-way ANOVA or Kruskal-Wallis variance analysis was used for comparisons among groups.



HRR1 was unchanged after training. HRR2 improved in the IT group after training, and post-training HRR2 values were significantly faster in the IT group than in controls. Both HRR1 and HRR2 was significantly faster, irrespective of exercise protocol in patients with abnormal baseline values after training.



HRR1 did not improve after training. HRR2 improved only in the IT group. Both HRRs in patients with abnormal baseline values improved after both exercise protocols. IT might be superior to CT in improving HRR2. Baseline HRR might play a role in its response to exercise.
The impact of HAART on cardiomyopathy among children and adolescents perinatally infected with HIV-1.

Previous studies of cardiomyopathy among children perinatally infected with HIV were conducted before the routine use of HAART. Nucleoside analogs [nucleoside reverse transcriptase inhibitors (NRTIs)], the backbone of HAART, have been associated with mitochondrial toxicity, which can lead to cardiomyopathy. We evaluated the association of HAART and specific NRTIs associated with mitochondrial toxicity, on development of cardiomyopathy among perinatally HIV-infected children.



Three thousand and thirty-five perinatally HIV-infected children enrolled in a US-based multicenter prospective cohort study were followed for cardiomyopathy, defined as a clinical diagnosis or initiation of digoxin, from 1993 to 2007.



Cox models were used to estimate the effects of HAART and NRTIs on cardiomyopathy, identify predictors of cardiomyopathy among HAART users, and estimate the association between development of cardiomyopathy and mortality.



Ninety-nine cases of cardiomyopathy were identified over follow-up (incidence rate: 5.6 cases per 1000 person-years) at a median age of 9.4 years. HAART was associated with a 50% lower incidence of cardiomyopathy compared with no HAART use (95% confidence interval: 20%, 70%). Zalcitabine (ddC) use, however, was associated with an 80% higher incidence of cardiomyopathy. Among HAART users, older age at HAART initiation, ddC use before HAART initiation, initiating a HAART regimen containing zidovudine (ZDV), and a nadir CD4 percentage less than 15% were independently associated with a higher rate of cardiomyopathy. Cardiomyopathy was associated with a six-fold higher mortality rate.



HAART has dramatically decreased the incidence of cardiomyopathy among perinatally HIV-infected children. However, they remain at increased risk for cardiomyopathy and ongoing ZDV exposure may increase this risk.
Feasibility, Motivation, and Selective Motor Control: Virtual Reality Compared to Conventional Home Exercise in Children with Cerebral Palsy

Children with cerebral palsy (CP) have difficulty controlling and coordinating voluntary muscle, which results in poor selective control of muscle activity. Children with spastic CP completed ankle selective motor control exercises using a virtual reality (VR) exercise system and conventional (Conv) exercises. Ankle movements were recorded with an electrogoniometer. Children and their parents were asked to comment on their interest in the exercise programs. Greater fun and enjoyment were expressed during the VR exercises. Children completed more repetitions of the Conv exercises, but the range of motion and hold time in the stretched position were greater during VR exercises. These data suggest that using VR to elicit or guide exercise may improve exercise compliance and enhance exercise effectiveness.
A comparison of high vs standard tidal volumes in ventilator weaning for individuals with sub-acute spinal cord injuries: a site-specific randomized clinical trial

Prospective, randomized, controlled parallel group trial with single-blinded data analysis.To determine the safety and efficacy of higher (20 ml kg−1 ideal body weight (IBW)) vs standard (10 ml kg−1 IBW) tidal volumes (Vt) for patients with sub-acute traumatic tetraplegia during ventilator weaning using a 14-day (minimum) weaning protocol.United States regional spinal cord injury treatment center.Thirty-three ventilator requiring inpatients were randomized to either the higher (Group 1) or the standard (Group 2) Vt protocol. Initially, all patients were ventilated at 10 ml kg−1 IBW Vt and 5 cm H2O of PEEP for 72 h. For Group 1, Vt was raised 100 ml kg−1 until reaching target Vt of 20 ml kg−1 IBW. Group 2 was maintained at Vt of 10 ml kg−1 IBW. Plateau pressures were kept at or below 30 cm H2O. Safety outcomes included incidence of adverse events.Because of smaller than expected enrollment, evaluation of efficacy was not possible. Therefore, we report the safety outcomes of 33 study participants. The 16 patients in Group 1 and 17 patients in Group 2 were demographically similar at baseline, except for age. The average age was 39.3 years in Group 1 and 27.2 years in Group 2, (P=0.002). There was no difference in median days to wean: 14.5 days in Group 1 and 14 days in Group 2. The incidence of adverse pulmonary events was similar between groups.Higher tidal volumes can be safely utilized during weaning of patients with tetraplegia from mechanical ventilation using a 14-day weaning protocol.
The beneficial effects of combining pharmacological and psychosocial treatment on remission and functional outcome in outpatients with schizophrenia.

The effects of pharmacological and psychosocial treatment on remission and the functional outcome in outpatients with schizophrenia were evaluated. Remission was assessed according to the criteria proposed by the Remission in Schizophrenia Working group and psychosocial functioning according to the Global Assessment of Functioning with a score > 60. Functional outcome was the result of these two variables.



One hundred fifty two patients were randomized to receive either, antipsychotic treatment as usual (TAU) or social skills training and family psychoeducation in addition to TAU. A final sample of 119 patients: n = 68 in the social skills training group, and n = 51 in the TAU group completed the study protocol. Patients were assessed at baseline and at 6-month follow-up.



At the end of the study, 80% of the patients fulfilled the criteria for symptomatic remission: 62 patients (91.2%) in the social skills training group in contrast to 34 patients (66.7%) in the TAU group. Functional improvement criteria were accomplished by 41 patients (34.5%) at the endpoint of the study. Forty of these patients (58.8%) belonged to social skills training and one patient to customary treatment (χ(2) = 41.7, df 1, p < 0.001) and when criteria for symptomatic remission and functional improvement were combined, 39 patients (97.5%) of the social skills training group and one patient (1.9%) of the customary treatment group achieved functional outcome.



The results emphasize the need for psychosocial interventions as conjoint to pharmacological treatment to improve functional outcome in schizophrenia patients.
Atomoxetine treatment in adolescents with attention-deficit/hyperactivity disorder.

This study compared two atomoxetine titration dosing schedules and two atomoxetine maintenance doses for treating adolescent attention-deficit/hyperactivity disorder (ADHD) inattention and hyperactivity/impulsivity.



Adolescents (N = 267) were randomized to a slow or fast titration schedule. Patients who responded continued on a 40-week maintenance treatment, randomized to either 0.8 or 1.4 mg/kg/day.



During the acute period, significant benefit was demonstrated with both titration schedules on the ADHD Rating Scale total score. Although patients in both groups maintained benefit relative to week 0, statistically significant loss of benefit was found for patients maintained on 0.8 mg/kg/day but not on 1.4 mg/kg/day. A similar pattern was observed on the Clinical Global Impressions-ADHD-Severity scores and Life Participation Scale for ADHD-Child Version scores. Mean grades for most subjects improved for patients in both maintenance treatment groups although most improvements were not statistically significant.



In adolescents with ADHD, treatment benefit at 8 weeks was better maintained long-term with 1.4 mg/kg/day than with 0.8 mg/kg/day. Improvement in adaptive functioning and age-appropriate developmental function was also demonstrated. Atomoxetine 0.8 and 1.4 mg/kg/day were equally well tolerated.



Maintenance of benefit with atomoxetine hydrochloride in adolescents with ADHD, NCT00191035.
Observational, longitudinal study of delirium in consecutive unselected acute medical admissions: age-specific rates and associated factors, mortality and re-admission.

We aimed to determine age-specific rates of delirium and associated factors in acute medicine, and the impact of delirium on mortality and re-admission on long-term follow-up.



Observational study. Consecutive patients over two 8-week periods (2010, 2012) were screened for delirium on admission, using the confusion assessment method (CAM), and reviewed daily thereafter. Delirium diagnosis was made using the Diagnostic and Statistical Manual Fourth Edition (DSM IV) criteria. For patients aged ≥65 years, potentially important covariables identified in previous studies were collected with follow-up for death and re-admission until January 2014.



503 consecutive patients (age median=72, range 16-99 years, 236 (48%) male).



Acute general medicine.



Delirium occurred in 101/503 (20%) (71 on admission, 30 during admission, 17 both), with risk increasing from 3% (6/195) at <65 years to 14% (10/74) for 65-74 years and 36% (85/234) at ≥75 years (p<0.0001). Among 308 patients aged >65 years, after adjustment for age, delirium was associated with previous falls (OR=2.47, 95% CI 1.45 to 4.22, p=0.001), prior dementia (2.08, 1.10 to 3.93, p=0.024), dependency (2.58, 1.48 to 4.48, p=0.001), low cognitive score (5.00, 2.50 to 9.99, p<0.0001), dehydration (3.53, 1.91 to 6.53, p<0.0001), severe illness (1.98, 1.17 to 3.38, p=0.011), pressure sore risk (5.56, 2.60 to 11.88, p<0.0001) and infection (4.88, 2.85 to 8.36, p<0.0001). Patients with delirium were more likely to fall (OR=4.55, 1.47 to 14.05, p=0.008), be incontinent of urine (3.76, 2.15 to 6.58, p<0.0001) or faeces (3.49, 1.81-6.73, p=0.0002) and be catheterised (5.08, 2.44 to 10.54, p<0.0001); and delirium was associated with stay >7 days (2.82, 1.68 to 4.75, p<0.0001), death (4.56, 1.71 to 12.17, p=0.003) and an increase in dependency among survivors (2.56, 1.37 to 4.76, p=0.003) with excess mortality still evident at 2-year follow-up. Patients with delirium had fewer re-admissions within 30-days (OR=0.32, 95% CI 0.09 to 1.1, p=0.07) and in total (median, IQR total re-admissions=0, 0-1 vs 1, 0-2, p=0.01).



Delirium affected a fifth of acute medical admissions and a third of those aged ≥75 years, and was associated with increased mortality, institutionalisation and dependency, but not with increased risk of re-admission on follow-up.
Randomised placebo-controlled trial of abciximab before and during coronary intervention in refractory unstable angina: the CAPTURE study

Platelet aggregation is a dominant feature in the pathophysiology of unstable angina. Percutaneous transluminal coronary angioplasty (PTCA) in patients with this disorder carries an increased risk of thrombotic complications. Abciximab (c7E3) blocks the platelet glycoprotein IIb/IIIa receptor, thus preventing platelet adhesion and aggregation. The CAPTURE study was a randomised placebo-controlled multicentre trial to assess whether abciximab can improve outcome in patients with refractory unstable angina who are undergoing PTCA.



The study recruited patients with refractory unstable angina, defined as recurrent myocardial ischaemia under medical treatment including heparin and nitrates. Predefined stopping rules were met at a planned interim analysis of data for 1050 patients, and recruitment was stopped. Data for 1265 patients (of 1400 scheduled) are presented here. After angiography, patients received a randomly assigned infusion of abciximab or placebo for 18-24 h before PTCA, continuing until 1 h afterwards. The primary endpoint was the occurrence within 30 days after PTCA of death (any cause), myocardial infarction, or urgent intervention for recurrent ischaemia. Analyses were by intention to treat.



By 30 days, the primary endpoint had occurred in 71 (11.3%) of 630 patients who received abciximab compared with 101 (15.9%) of 635 placebo recipients (p = 0.012). The rate of myocardial infarction was lower in the abciximab than in the placebo group before PTCA (four [0.6%] vs 13 [2.1%], p = 0.029) and during PTCA (16 [2.6%] vs 34 [5.5%], p = 0.009). Major bleeding was infrequent, but occurred more often with abciximab than with placebo (24 [3.8%] vs 12 [1.9%], p = 0.043). At 6-month follow-up, death, myocardial infarction, or repeat intervention had occurred in 193 patients in each group.



In patients with refractory unstable angina, treatment with abciximab substantially reduces the rate of thrombotic complications, in particular myocardial infarction, before, during, and after PTCA. There was no evidence that this regimen influenced the rate of myocardial infarction after the first few days, or the need for subsequent reintervention.
Treatment of persistent shoulder pain with sodium hyaluronate: a randomized, controlled trial. A multicenter study.

Presently, there are no approved nonoperative therapies for the ongoing treatment of persistent shoulder pain. Preliminary data suggest that intra-articular sodium hyaluronate injections may be beneficial for the treatment of persistent shoulder pain resulting from various etiologies. The present study evaluated the efficacy and safety of sodium hyaluronate (Hyalgan; molecular weight, 500 to 730 kDa) for these patients.



Six hundred and sixty patients with persistent shoulder pain and limitation resulting from glenohumeral joint osteoarthritis, rotator cuff tear, and/or adhesive capsulitis who had had a failure of conventional therapy were enrolled in this double-blind, randomized, phosphate-buffered saline solution-controlled study, and 456 patients completed twenty-six weeks of follow-up. Patients were randomized to receive either five weekly intra-articular injections of sodium hyaluronate, three weekly intra-articular injections of sodium hyaluronate followed by two weekly intra-articular injections of saline solution, or five weekly intra-articular injections of saline solution. The main outcomes were improvement in terms of shoulder pain on movement at thirteen weeks after the initiation of treatment (as assessed with use of a 100-mm visual analog scale) and the treatment effect throughout twenty-six weeks.



For the overall intent-to-treat population, patients who were managed with sodium hyaluronate had greater pain relief than controls did; significant differences were noted at Week 7 (for the five-injection hyaluronate group), Week 17 (for the three and five-injection hyaluronate groups), and Week 26 (for the three-injection hyaluronate group). Analysis of the stratified populations clearly established that this effect was due to benefits experienced by the patients with osteoarthritis. The treatment effect through twenty-six weeks was significant in patients with osteoarthritis in the three-injection (p = 0.003) and five-injection (p = 0.002) groups, with no significant difference for either regimen in patients without osteoarthritis. The safety profile was very favorable, with no product-related serious adverse effects and no between-group differences for any reported adverse event.



Although the primary end point of this study (that is, improvement in terms of shoulder pain at thirteen weeks) was not achieved, the overall findings, including secondary end points, indicate that sodium hyaluronate (500 to 730 kDa) is effective and well tolerated for the treatment of osteoarthritis and persistent shoulder pain that is refractory to other standard nonoperative interventions.
Phase I/II study of sequential chemoimmunotherapy (SCIT) for metastatic melanoma: outpatient treatment with dacarbazine, granulocyte-macrophage colony-stimulating factor, low-dose interleukin-2, and interferon-alpha

A regimen of sequential chemoimmunotherapy (SCIT) was studied in a phase I/II study to analyze toxicity, anti-tumor and immunomodulatory effects in patients with previously untreated metastatic cutaneous melanoma. Treatment consisted of dacarbazine (DTIC) 800 mg/m2 administered intravenously (i.v.) on day 1, followed by subcutaneous (s.c.) molgramostim (GM-CSF), 10 times 2.5 µg/kg on days 2 to 12, s.c. low-dose interleukin-2 (IL-2), 10 times 1.8 MU on days 8 to 18, and s.c. interferon-alpha-2b (IFN-α), 5 times 6 MU on days 15 to 20. Dosages were not escalated. Therapy was given in the form of outpatient treatment. Changes in T-lymphocyte phenotype and in soluble mediators were monitored during treatment. A total of 32 patients with stage IV melanoma were enrolled in the study. Treatment was well tolerated, without serious toxicity. In all cases, it could be given as outpatient treatment. Ten subjects out of the 31 patients evaluated showed an objective response, with 4 complete responses (CR) and 6 partial responses (PR); the response rate amounted to 32% (95% CI: 16–49%). Median survival of all patients was 8 months, with those patients who responded to treatment living longer than the non-responding group. Survival rate at 1 year was 22%. Monitoring of the effects of treatment revealed increased numbers of activated T-lymphocytes, both in the CD4 and in the CD8 subsets. The levels of soluble mediators such as sIL-2R and sCD8 were also increased. Changes were noted as early as the GM-CSF treatment period, and were observed to a further extent during IL-2 treatment. In the present study, it was found that this sequential chemoimmunotherapy regimen consisting of 4 agents (DTIC, GM-CSF, IL-2, IFN-α) has acceptable toxicity, can be administered on an outpatient basis, results in increased numbers of activated T-lymphocytes, and induces activity against metastatic melanoma that warrants further investigation.
Lack of Association Between Elevated Urinary Levels of Interleukin-10 and Interferon Gamma With the Presence of Inflammation in Kidney Transplant Recipients.

A lot of evidence has demonstrated the importance of different cytokines in acute renal rejection. Previous studies have examined the presence or absence of interleukin (IL)-10 in related immunopathologic rejection grafts as well as other interleukins. Studies in human transplantation show elevated levels of IL-10 and gamma interferon (INF-γ) in inflammation and rejection.



The objective of this study was to demonstrate the lack of association of elevated urinary levels of IL-10 and IFN in the presence of active inflammation.



An observational, descriptive, cross-sectional study conducted in transplant recipients at 12 months of follow-up after renal transplantation. In those who were held biopsy after renal transplantation at one year follow-up, or allograft dysfunction, we also measured IL-10 and INF-γ in the urine. The following were considered as variables: age, body mass index (BMI), gender, transplant type, creatinine, chronic kidney disease epidemiology collaboration equation, (CKD-EPI), modification of diet in renal disease study equation (MDRD), Banff classification, and levels of IL-10 and INF-γ. Statistical analysis was performed calculating a sample size of 25 patients, with an alpha bias of 0.05%, yielding measures of central tendency and determining no association between levels of IL-10 and INF-γ with the presence of rejection using SPSS 21.0 program.



A total of 50 patients, 34 (68%) males, 16 (32%) females, with an average 31.7 ± 9.9 years, weight of 64.91 ± 13.84 kg, size 1.60 ± 0.10 m and 24.97 ± 4.07 BMI were included,39 (78%) living donor and 11 (22%) cadaveric. Twenty-six (52%) showed inflammation in the biopsy and 24 (48%) showed none. Mean creatinine was 1.81 ± 1.5, and the estimated glomerular filtration rate (eGFR) was 55.27 ± 22.46, 65.76 ± 26.7. (MDRD and CKD-EPI, respectively). No statistical difference was found in the levels of IL-10 and IFN-γ using analysis of variance. (ANOVA; P = .467 and P = .063, respectively) Based on Banff, the inflammation on biopsy score was 2.78 ± 2.84. There was statistical significance (P < .05) with respect to the Cr and eGFR by different equations. There were no significant interactions between cytokine levels and more than 1 factor. (as indicated by P < .2).



No significant differences were observed in the level of interleukins in patients with and without inflammation, denoting an adequate immunosuppression in most of these patients. Determination of inflammatory cytokines in urine could be used as a determinant of a good immunosuppression status, rather than as an early marker of rejection.
The effects of therapeutic taping on gross motor function in children with cerebral palsy.

Therapeutic taping to address dysfunctional sitting control in children with cerebral palsy (CP) was investigated in this study.



Eighteen children with quadriplegic CP, Gross Motor Function Classification System for Cerebral Palsy levels IV (n = 9) and V (n = 9) participated in the 12-week program. Subjects were assigned randomly to one of two groups: therapeutic taping + physical therapy or physical therapy only. Therapeutic taping was applied for periods of up to 72 hours over the paraspinal region. The effects were assessed with the Gross Motor Function Measure (GMFM-88) at baseline, six weeks, and 12 weeks. A factorial analysis of variance was used to examine group differences over time.



No significant differences were found for the GMFM-88 scores between groups over time.



Therapeutic taping does not evoke a positive functional change in the seated postural control of children with quadriplegic cerebral palsy. Subjective observation, however, suggested that one child with athetosis benefited from therapeutic taping over the paraspinal region.