nils-herrmann/clean_scirepeval huggingface dataset:
The effect of a 4-week comprehensive rehabilitation program on postural control and lower extremity function in individuals with chronic ankle instability.

Prospective, randomized controlled trial.



To examine the effects of a 4-week rehabilitation program for chronic ankle instability (CAI) on postural control and lower extremity function.



CAI is associated with residual symptoms, performance deficits, and reinjury. Managing CAI is challenging and more evidence is needed to guide effective treatment.



Subjects with unilateral CAI were randomly assigned to the rehabilitation (CAI-rehab, n=16) or control (CAI-control, n=13) group. Subjects without CAI were assigned to a healthy group (n=19). Baseline testing included the (1) center of pressure velocity (COPV), (2) star excursion balance test (SEBT), and (3) Foot and Ankle Disability index (FADI) and FADI-Sports Subscale (FADI-Sport). The CAI-rehab group completed 4 weeks of rehabilitation that addressed range of motion, strength, neuromuscular control, and functional tasks. After 4 weeks, all subjects were retested. Nonparametric analyses for group differences and between-group comparisons were performed.



Subjects with CAI demonstrated deficits in postural control and SEBT reach tasks of the involved limb compared to the uninvolved limb and reported functional deficits of the involved limb compared to healthy subjects. Following rehabilitation, the CAI-rehab group had greater SEBT reach improvements on the involved limb than the other groups and greater improvements in FADi and FADI-Sport scores.



These results demonstrate postural control and functional limitations exist in individuals with CAl. In addition, rehabilitation appears to improve these functional limitations. Finally, there is evidence to suggest the SEBT may be a good functional measure to monitor change after rehabilitation for CAI.
Total hip arthroplasty using TRI-LOCK® DePuy bone preservation femoral stem: our experience.

In this study we report our 3-years experience (from January 2010 to December 2013) of 101 total hip arthroplasties using Tri-Lock® DePuy bone preservation femoral stem, all performed in our clinic.



101 patients (F54-M47; median age around 69 yrs, range 42-84 yrs). 51 arthroplasties were implanted on the right side whereas 50 on the left side. The average follow-up was 27,3 months. All the arthroplasties were coupled with Pinnacle® polyethylene acetabular cup system; 98 prostheses were implanted cementless whereas cement was used in 3 cases.



The Tri-Lock® femoral stem allows both soft tissues and bone stock preservation, leading to greater trochanter maintenance, less spongy bone removal and distal cavity bone tissue conservation. In our experience, we were able to implant the Tri-Lock® femoral stem even in osteoporotic and overweight patients using Gription® porous coating. This allowed for commencing an intensive rehabilitation program with stable load from the following day, without observing any early complications or loosening.



According to us, this device is solid and safe, providing remarkable sparing of both soft tissues and bone stock.
Impact of comprehensive geriatric assessment on survival, function, and nutritional status in elderly patients with head and neck cancer: protocol for a multicentre randomised controlled trial (EGeSOR)

Survival is poorer in elderly patients with head and neck squamous cell carcinomas [HNSCCs] than in younger patients. Possible explanations include a contribution of co-morbidities to mortality, frequent refusal of standard therapy, and the use of suboptimal treatments due to concern about toxicities. The Comprehensive Geriatric Assessment [CGA] is a multidimensional assessment of general health that can help to customise treatment and follow-up plans. The CGA has been proven effective in several health settings but has not been evaluated in randomised studies of patients with cancer. Our aim here was to assess the impact of the CGA on overall survival, function, and nutritional status of elderly patients with HNSCC. EGeSOR is an open-label, multicentre, randomised, controlled, parallel-group trial in patients aged 70 years or older and receiving standard care for HNSCC. The intervention includes four components: the CGA conducted by a geriatrician before cancer treatment, participation of the same geriatrician in cancer treatment selection, a standardised geriatric therapeutic intervention designed by the same geriatrician; and geriatric follow-up for 24 months. The primary endpoint, assessed after 6 months, is a composite criterion including death, functional impairment [Activities of Daily Living score decrease ≥2], and weight loss ≥10%. Secondary endpoints include progression-free survival, unscheduled admissions, quality of life, treatment toxicities, costs, and completion of the planned cancer treatment. A centralised online system is used to perform 1:1 randomisation with a minimisation algorithm for centre, age, T and N stages, and tumour site [oral, oropharyngeal, hypopharyngeal, or laryngeal]. The estimated sample size is 704 patients, who are being recruited by 14 centres in 9 French cities. EGeSOR is the first randomised trial of the CGA in elderly cancer patients. We expect the CGA to have direct clinical benefits on the management of elderly patients with HNSCC. If this expectation is fulfilled, the trial may lead to modifications of the management model for elderly patients with cancer.
Once-daily abacavir/lamivudine/zidovudine plus tenofovir for the treatment of HIV-1 infection in antiretroviral-naïve subjects: a 48-week pilot study.

To assess the safety and efficacy of a 4-drug, 3-tablet, once-daily (qd) regimen consisting of abacavir/lamivudine/zidovudine (ABC/3TC/ZDV; 2 tablets) and tenofovir (TDF) in antiretroviral-naïve patients with plasma HIV-1 RNA 30,000 copies/mL at 48 weeks.



All participants received ABC/3TC/ZDV (300/150/300 mg) and TDF (300 mg) qd in this pilot, open-label, multicenter study. Intent-to-treat (ITT) analyses were conducted to evaluate virologic and immunologic efficacy.



Of the 123 participants enrolled, 52 (42%) prematurely discontinued study for adverse events (14), were lost to follow-up (13), had virologic nonresponse (12), and withdrew for other reasons (13). At week 48, by ITT missing=failure analysis, 41% (51/123) and 51% (63/123) of participants had plasma HIV-1 RNA <50 copies/mL and <400 copies/mL, respectively; by ITT-observed analysis, 75% (51/68) and 93% (63/68) had plasma HIV-1 RNA <50 copies/mL and <400 copies/mL, respectively; 11% (14/123) met virologic nonresponse criteria. Median week 48 change in CD4+ cell count from baseline was +127 cells/mm3. Median week 48 changes from baseline for fasting lipids were as follows: cholesterol (-9 mg/dL), HDL (+1 mg/dL), LDL (-9 mg/dL), and triglycerides (-4 mg/dL).



A high rate of premature discontinuations contributed to the overall suboptimal virologic response to ABC/3TC/ZDV+TDF qd; however, the regimen was not associated with high rates of virologic failure previously observed with TDF+ABC/3TC.
Predictive and prognostic analysis of PIK3CA mutation in stage III colon cancer intergroup trial.

Somatic mutations in PIK3CA (phosphatidylinositol-4,5-bisphosphonate 3-kinase [PI3K], catalytic subunit alpha gene) activate the PI3K-AKT signaling pathway and contribute to pathogenesis of various malignancies, including colorectal cancer.



We examined associations of PIK3CA oncogene mutation with relapse, survival, and treatment efficacy in 627 stage III colon carcinoma case subjects within a randomized adjuvant chemotherapy trial (5-fluorouracil and leucovorin [FU/LV] vs irinotecan [CPT11], fluorouracil and leucovorin [IFL]; Cancer and Leukemia Group B 89803 [Alliance]). We detected PIK3CA mutation in exons 9 and 20 by polymerase chain reaction and pyrosequencing. Cox proportional hazards model was used to assess prognostic and predictive role of PIK3CA mutation, adjusting for clinical features and status of routine standard molecular pathology features, including KRAS and BRAF mutations and microsatellite instability (mismatch repair deficiency). All statistical tests were two-sided.



Compared with PIK3CA wild-type cases, overall status of PIK3CA mutation positivity or the presence of PIK3CA mutation in either exon 9 or 20 alone was not statistically significantly associated with recurrence-free, disease-free, or overall survival (log-rank P > .70; P > .40 in multivariable regression models). There was no statistically significant interaction between PIK3CA and KRAS (or BRAF) mutation status in survival analysis (P(interaction) > .18). PIK3CA mutation status did not appear to predict better or worse response to IFL therapy compared with FU/LV therapy (P(interaction) > .16).



Overall tumor PIK3CA mutation status is not associated with stage III colon cancer prognosis. PIK3CA mutation does not appear to serve as a predictive tumor molecular biomarker for response to irinotecan-based adjuvant chemotherapy.
Imatinib mesylate is effective in children with chronic myelogenous leukemia in late chronic and advanced phase and in relapse after stem cell transplantation

A multicentric phase 2 study was conducted to determine the efficiency and the tolerance of imatinib mesylate in children with chronic myelogenous leukemia (CML) in advanced phase of the disease, in relapse after stem cell transplantation, or in case of failure to an interferon α-based regimen. In all, 30 children from eight European countries were enrolled. In 18 children assessable for hematologic response, imatinib mesylate induced complete hematologic response in eight (80%) of the 10 patients included in chronic phase and in six (75%) of eight enrolled in advanced phase of the disease with acceptable toxicity. In 27 patients assessable for cytogenetic response, imatinib mesylate induced disappearance of Philadelphia chromosome-positive bone marrow cells in 12 (60%) of 20 children included in chronic phase and in two (29%) of seven included in advanced phase. A reduction of the bcr-abl/abl ratio to less than 10−4 was achieved in 11 (50%) of the children included in chronic phase. Estimated 12-month overall survival rate was 95% (95% CI, 87–100%) for the patients included in chronic phase and 75% (95%CI, 45–100%) for those enrolled in advanced phase. Imatinib mesylate is well tolerated and molecular remission can be achieved in children with CML.
Multicenter, double-blind, randomized, placebo-controlled trial assessing the efficacy and safety of proton pump inhibitor lansoprazole in infants with symptoms of gastroesophageal reflux disease.

To assess the efficacy and safety of lansoprazole in treating infants with symptoms attributed to gastroesophageal reflux disease (GERD) that have persisted despite a >or= 1-week course of nonpharmacologic management.



This multicenter, double-blind, parallel-group study randomized infants with persisting symptoms attributed to GERD to treatment with lansoprazole or placebo for 4 weeks. Symptoms were tracked through daily diaries and weekly visits. Efficacy was defined primarily by a >or= 50% reduction in measures of feeding-related crying and secondarily by changes in other symptoms and global assessments. Safety was assessed based on the occurrence of adverse events (AEs) and clinical/laboratory data.



Of the 216 infants screened, 162 met the inclusion/exclusion criteria and were randomized. Of those, 44/81 infants (54%) in each group were responders--identical for lansoprazole and placebo. No significant lansoprazole-placebo differences were detected in any secondary measures or analyses of efficacy. During double-blind treatment, 62% of lansoprazole-treated subjects experienced 1 or more treatment-emergent AEs, versus 46% of placebo recipients (P= .058). Serious AEs (SAEs), particularly lower respiratory tract infections, occurred in 12 infants, significantly more frequently in the lansoprazole group compared with the placebo group (10 vs 2; P= .032).



This study detected no difference in efficacy between lansoprazole and placebo for symptoms attributed to GERD in infants age 1 to 12 months. SAEs, particularly lower respiratory tract infections, occurred more frequently with lansoprazole than with placebo.
Randomised controlled trial examining the effect of exercise in people with rheumatoid arthritis taking anti-TNFα therapy medication

Substantial progress has been made in the medical management of rheumatoid arthritis (RA) over the past decade with the introduction of biologic therapies, including anti-tumour necrosis factor alpha (anti-TNFα) therapy medications. However, individuals with RA taking anti-TNFα medication continue to experience physical, psychological and functional consequences, which could potentially benefit from rehabilitation. There is evidence that therapeutic exercise should be included as an intervention for people with RA, but to date there is little evidence of the benefits of therapeutic exercise for people with RA on anti-TNFα therapy medication. A protocol for a multicentre randomised controlled three-armed study which aims to examine the effect of dynamic group exercise therapy on land or in water for people with RA taking anti-TNFα therapy medication is described.



Six hundred and eighteen individuals with RA, on anti-TNFα therapy medication, will be randomised into one of 3 groups: a land-based exercise group; a water-based exercise group or a control group. The land and water-based groups will exercise for one hour, twice a week for eight weeks. The control group will receive no intervention and will be asked not to alter their exercise habits for the duration of the study. The primary outcome measure, the Stanford Health Assessment Questionnaire Disability Index (HAQ-DI) which measures functional ability, and secondary measures of pain, fatigue and quality of life, will be assessed at baseline, eight and 24 weeks by an independent assessor unaware of group allocation. Changes in outcome from 0 to 8 weeks and 0 to 24 weeks in the 'land-based exercise group versus control group' and the 'water-based exercise group versus control group' will be examined. Analysis will be conducted on an intention to treat basis.



This trial will evaluate the effectiveness of group exercise therapy on land or in water, for people with RA taking anti-TNFα therapy medication. If these exercise groups are found to be beneficial, they could be conducted in local community facilities thus making these forms of exercise more easily accessible for individuals and potentially reduce the burden on health services.
Glucocorticoid-induced osteoporosis in the lumbar spine, forearm, and mandible of nephrotic patients: A double-blind study on the high-dose, long-term effects of prednisone versus deflazacort

The long-term effects of high dose steroid treatment with either prednisone (PDN) or deflazacort (DFZ) were examined on various parts of the skeleton in 29 patients with nephrotic syndrome. All had normal skeleton at the start of the steroid treatment. At the beginning, PDN was given as 80 mg/day and tapered down to 20 mg/day for 1 year and DFZ was given in an equipotent dosage. Twenty-three patients completed 6 months of treatment, and 18 patients completed 12 months of treatment. Beside laboratory parameters to ensure the effect of treatment on the nephrotic syndrome, all had measurements of the bone mineral content (BMC) at 0, 6, and 12 months of treatment. BMC was measured by single photon absorptiometry of both forearms and by dual photon absorptiometry of the mandible, forearms, and lumbar spine. The effect of DFZ was compared to that of PDN due to a potential “calcium sparing” effect of DFZ. The therapeutical effects on the nephrotic syndrome were not different between the two drugs. Urinary 24-hour protein decreased from 9.9 to 1.1 g in the DFZ-treated patients and from 8.0 to 1.4 g in the PDN-treated patients. Plasma albumin concentration normalized in both groups. Both groups of steroid-treated patients had a significant reduction of the BMC levels in all parts of the skeleton. However, the bone decay rates per month were significantly different between different bone regions and between different drug regimes. In the forearm, the bone decay rate was 5.3%/year in the PDN group and 2.0%/year in the DFZ group (P<0.001). In the mandible, decay rate was 7.0%/year in both groups, and in the lumbar spine it was 12.5%/year in the PDN group and 6.8%/year in the DFZ group (P<0.01). Thus, the bone loss in the PDN-treated group was significantly higher than that of the DFZ-treated patients, despite a similar therapeutical effect on the nephrotic syndrome. Therefore, the detrimental effect of long-term steroid treatment on the skeleton may not be abolished, but can be reduced significantly by using deflazacort instead of prednisone.
Pregabalin beneficial effects on sleep quality or health-related quality of life are poorly correlated with reduction on pain intensity after an 8-week treatment course.

Pregabalin (PGB) has been shown to improve sleep quality and health-related quality of life (HRQoL) as well as pain intensity in patients with neuropathic pain.



The objective of the study was to explore the magnitude of the correlations between changes in pain intensity, sleep quality, and HRQoL after PGB treatment.



One hundred thirty-eight patients with neuropathic pain of any origin and without an adequate response to analgesics received an 8-week treatment course of PGB in an open-label fashion. Pain intensity, sleep quality, and HRQoL outcomes were evaluated at baseline and at week 8 by means of an 11-point (0-10) numerical rating scale (NRS), the Pittsburgh Sleep Quality Index (PSQI), and the EuroQol health-state visuoanalogic scale (EQ-5D VAS) score, respectively.



At week 8, mean PGB dose was 166.7 ± 7.8 mg/d. Pain intensity NRS score, PSQI total score, and EQ-5D VAS score were improved by 66.5% ± 1.9%, 40.0% ± 3.6%, and 26.4% ± 4.7% (all P < 0.01), respectively. Correlations between percent change from baseline in pain NRS score and PSQI total score or EQ-5D VAS scores were r = 0.36 (P < 0.01, R = 0.11) and r = -0.20 (P < 0.02, R = 0.05), respectively. A multivariate logistic regression analysis disclosed that PSQI score change below the median (ie, a better outcome) was related to higher EQ-5D VAS score change (odds ratio, 2.15; 95% confidence interval, 1.09-4.25), whereas pain intensity NRS score change below the median was not (odds ratio, 1.58; 95% confidence interval,0.78-3.23).



In our study, PGB-related improvements in sleep quality and HRQoL were marginally related to reductions in pain intensity in patients with neuropathic pain. Improvement in sleep quality was a significant predictor of better HRQoL, whereas pain intensity reduction was not.
Comparison between automatic tube compensation and continuous positive airway pressure during spontaneous breathing trials.

Various methods to perform spontaneous breathing trials (SBTs) exist, but no one method has been shown to be superior. Automatic tube compensation (ATC) is a new and potentially advantageous ventilation mode to use during SBT. We compared ATC to continuous positive airway pressure (CPAP) during SBTs, to determine their efficacy in identifying patients ready to be liberated from mechanical ventilation.



We randomized 118 adults in a general intensive care unit on mechanical ventilation for > or = 24 h who were about to undergo an SBT as part of an established respiratory-therapist-driven weaning protocol to undergo 30 min SBT with ATC or CPAP with no pressure support. We predefined the SBT-failure criteria. The primary outcome was duration of weaning (days from first SBT to extubation). Other outcomes included unsuccessful extubation within 48 h, first-SBT-pass rate, and total duration of mechanical ventilation.



We found a trend toward less failure of first SBT with ATC, compared to CPAP (3% vs 13% respectively, P = .09), but no difference in duration of weaning, rate of unsuccessful extubation, or duration of mechanical ventilation.



When applied as part of a respiratory-therapist-driven weaning protocol in a general intensive-care population, SBTs with ATC were safe but did not hasten liberation from mechanical ventilation, when compared to CPAP.
Electrical connections between pulmonary veins: implication for ostial ablation of pulmonary veins in patients with paroxysmal atrial fibrillation.

Electrical disconnection of the myocardial extensions into arrhythmogenic pulmonary veins (PVs) is recognized as a curative technique for paroxysmal atrial fibrillation (AF). However, the presence of electrical connections between the PVs, which may make achievement of PV disconnection difficult, has not been systematically evaluated.



Forty-nine consecutive patients with drug-resistant AF underwent ostial radiofrequency (RF) catheter ablation of arrhythmogenic PVs with foci triggering AF. Pacing from inside the targeted PV was performed after each RF delivery to identify the left atrial exit site of the residual venoatrial conduction. Successful PV disconnection was defined as achieving elimination of the PV potentials during sinus rhythm or left atrial pacing, and the loss of left atrial conduction during intra-PV pacing. A total of 112 arrhythmogenic PVs were identified. PV disconnection was achieved with 10+/-6.1 minutes of RF delivery to the ostia of 101 targeted PVs. In 7 left superior (LS) PVs from 7 patients (14%), the earliest atrial activity was recorded from the left inferior (LI) PV ostium during intra-LSPV pacing after 11+/-4.7 minutes of RF delivery to the LSPV ostium. Disconnection of these LSPVs was achieved by LIPV disconnection. In the remaining 4 PVs from 4 patients, PV disconnection could not be achieved.



Fourteen percent of the patients had electrical connections between contiguous PVs. In these patients, ostial ablation of an untargeted PV was required for successful targeted PV disconnection.
Unexpected nocturnal hypoxia in patients with acute stroke.

Patients who have had a stroke are at risk of hypoxia through alterations in the central regulation of respiration, through aspiration, and through respiratory muscle weakness. Sleep-related breathing disorders are common and may lead to episodes of nocturnal hypoxia even when daytime oxygenation is normal. The aim of this study was to assess the prevalence of unexpected nocturnal hypoxia in stroke patients.



Consecutive adult patients with stroke were recruited within 72 hours of admission to hospital. Patients with indications for oxygen treatment were excluded. Older adults from the local community were recruited as control subjects. Oxygenation was assessed by pulse oximetry (Minolta 3i) for 5 minutes when awake before bedtime and continuously from 11 pm until 7 am.



Of the 238 potentially eligible stroke patients, 120 were excluded because they required oxygen, 118 were recruited, and 100 had adequate pulse oximetry data. The mean+/-SD age was 74+/-8 years for stroke patients and 72+/-8 years for control subjects (n=85). Mean awake oxygen saturation (So2) was 94.5+/-1.7% for the stroke group and 95.8+/-1.7% for the control group (P<0.001). Mean nocturnal So2 was 93.5+/-1.9% in stroke patients and 94.3+/-1.9% in control subjects (P<0.01). Stroke patients had a higher oxygen desaturation index (ODI 4%) (8.9 versus 2.1, P<0.001). In addition, 23% of stroke patients spent >30 minutes with So2 <90% during the night.



Oxygen saturation at night is approximately 1% lower than when awake. Almost a quarter of stroke patients who are normoxic at screening during the day spend >30 minutes with an oxygen saturation <90%.