nils-herrmann/clean_scirepeval huggingface dataset:
Pulmonary function change in patients with Sauropus androgynus-related obstructive lung disease 15 years later.

Little is understood about the clinical course and prognosis of patients with Sauropus androgynus-related obstructive lung disease. The aim of this study was to investigate their clinical manifestations and pulmonary function change 15 years after the acute episode.



A descriptive, observational study of patients with S androgynus-related obstructive lung disease, diagnosed 15 years ago, was conducted. We evaluated their pulmonary function and the Modified Medical Research Council (MMRC) dyspnea scale. Saint George's Respiratory Questionnaire (SGRQ) was also performed. Age- and forced expiratory volume in one second (FEV1)-matched chronic obstructive pulmonary disease (COPD) patients were used as a reference group for comparison of clinical manifestations.



Twenty-nine of 49 patients, diagnosed at our hospital 15 years ago, could be contacted. Four patients died and one patient was ventilator-dependent. Sixteen patients were willing to come to our hospital to have pulmonary function and questionnaire evaluation. The FEV1 of these patients declined only 1.6 ± 21.6 mL/year over a 15-year period. Meanwhile, the severity of their dyspnea and their health-related quality of life were better than age- and FEV1-matched COPD patients as shown by the MMRC dyspnea scale (1.4 ± 0.8 vs. 2.0 ± 1.0; p = 0.037) and symptom domain of the SGRQ (32.6 ± 18.4 vs. 43.5 ± 20.3; p = 0.006).



After an acute deterioration, patients with S androgynus-related obstructive lung disease had a stationary pulmonary function over a period of 15 years, and their clinical manifestations were less severe than age- and FEV1-matched COPD patients. A further study with a larger sample size may be needed to confirm these findings.
Phase I/II docetaxel plus concurrent hyperfractionated radiotherapy in locally advanced unresectable head and neck cancer (TAX.ES1.102 study).

Concurrent chemotherapy and radiotherapy is recommended for the treatment of locally advanced unresectable head and neck (H&N) cancer.



The primary purpose of the Phase I part of the study was to determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT) and recommended dose (RD) of docetaxel with hyperfractionation radiotherapy. The primary objective of the Phase II part was to determine the response rate to the RD of treatment and, secondarily, to assess the toxicity of the schedule, time to progression, duration of response and overall survival (OS).



Patients (n=9 in Phase I; n=19 in Phase II) had unresectable H&N cancer. The starting docetaxel dose was 20 mg/m(2) plus hyperfractionated radiotherapy. Ramping of docetaxel was 5 mg/m(2) if MTD was not reached.



MTD of docetaxel was 20 mg/m(2). Limiting toxicities were grade 4 pneumonia and grade 4 mucositis. The RD was 15 mg/m(2). Phase II initial response was 76% (CR=18%; PR=9%); updated response was 89% (CR=59%; PR=29%). The median progression-free survival was 7.8 months (95%CI: 0-22.3) and the median OS was 15.1 months (95%CI: 0-35.9). Grade 3-4 toxicities included mucositis (91%), pneumonia (27%) and fatigue (27%). There were 5 toxic deaths (2 from intestinal perforation, 3 from pneumonia).



Weekly docetaxel+hyperfractionation radiotherapy is active but with high toxicity rates and, hence, this treatment regimen would be difficult to justify.
Nimesulide in the Treatment of Advanced Cancer Pain

The analgesic efficacy and tolerability of nimesulide and naproxen were compared in 68 patients with advanced cancer who needed to be treated with nonsteroidal anti-inflammatory drugs according to the first step of the pharmacological analgesic scale of the WHO. Patients received either nimesulide 200mg or naproxen 500mg twice daily. The analgesic efficacy and tolerability of the 2 drugs appeared to be similar. Both drugs were effective and were associated with a low incidence of adverse reactions.
A randomised placebo-controlled trial of oral hydrocortisone for treating tobacco withdrawal symptoms

Many smokers experience a decline in cortisol to sub-normal levels during the first days of smoking cessation. A greater decline in cortisol is associated with more intense cigarette withdrawal symptoms, urge to smoke and relapse to smoking. Findings from an uncontrolled study suggest that glucocorticoids could ameliorate cigarette withdrawal. We investigated whether taking oral hydrocortisone would reduce withdrawal symptoms and the desire to smoke on the first day of temporary smoking abstinence compared with placebo. Using a double-blind within-subject randomised crossover design, 48 smokers took a single dose of 40 mg hydrocortisone, 20 mg hydrocortisone or placebo following overnight smoking abstinence. Abstinence was maintained through the afternoon, and withdrawal symptoms and the desire to smoke were rated across the morning. Salivary cortisol was assessed in the afternoon prior to abstinence (baseline) and while abstinent after each treatment. There was a significant dose–response relation between dose of hydrocortisone and reduction in depression and anxiety ratings while abstinent, but there were no other statistically significant associations with dose. Overall, the decline in cortisol following smoking cessation (placebo only) was not significant. Cortisol level on the afternoon of smoking abstinence was not significantly associated with symptom ratings. Supplements of hydrocortisone do not reduce the desire to smoke but may ameliorate withdrawal-related depression and anxiety, although the clinical benefit is slight.
Annexin A1 down-regulation in oral squamous cell carcinoma correlates to pathological differentiation grade.

Functional role of Annexin A1 in tumorigenesis is poorly understood. The aim of this study was to investigate the relationship between Annexin A1 protein expression and pathological differentiation grade in biopsy samples from a large cohort of patients with oral squamous cell carcinoma (OSCC); and to evaluate the potential role of Annexin A1 on cell proliferation and tumorigenesis of OSCC.



We investigated the relationship between Annexin A1 expression by immunohistochemical staining and pathological differentiation grade of biopsy samples from 232 OSCC patients, and the relationship between Annexin A1 expression and cell proliferation as well as tumor formation using both in vitro and in vivo OSCC models.



Annexin A1 expression correlated significantly with pathological differentiation grade in OSCC patients, a lower Annexin A1 expression correlating with a poorer differentiation grade. Forced Annexin A1 overexpression in OSCC cell lines, CAL27 and Tca8113, significantly reduced the cell proliferation whereas down-regulation of Annexin A1 expression in OSCC cell line, HB96, significantly increased proliferation of HB96 cells. Tumors formed from CAL27 cells overexpressing Annexin A1 grown significantly slower compared to the parental CAL27 cells in nude mice and showed a significantly reduced nuclear Ki-67 labeling index. Interestingly, these tumors also showed a well differentiated histology pattern whereas the tumors formed from the parental cells were consistently moderately differentiated.



These data support a significant correlation between Annexin A1 expression and pathological differentiation grade, and a functional role of Annexin A1 in inhibiting cell proliferation and cell differentiation in OSCC.
Impact of caregiver group psychoeducation on the course and outcome of bipolar patients in remission: a randomized controlled trial.

Although there are some randomized controlled trials that highlight the positive role of family-focused treatment added to pharmacotherapy in bipolar disorder, no trials using contemporary methodologies have analyzed the specific effect of working with caregiver-only groups. The aim of this study was to assess the efficacy of a psychoeducational group intervention focused on caregivers of euthymic bipolar patients.



A total of 113 medicated euthymic bipolar outpatients who lived with their caregivers were randomized into an experimental and a control group. Caregivers in the experimental group received twelve 90-min group psychoeducation sessions focused on knowledge of bipolar disorder and training in coping skills. The patients did not attend the groups. Caregivers assigned to the control group did not receive any specific intervention. Patients were assessed monthly during both the intervention and the 12 months of follow-up. The primary outcome was time to any mood recurrence.



Psychoeducation group intervention focused on the caregivers of bipolar patients carried a reduction of the percentage of patients with any mood recurrence (chi2 = 6.53; p = 0.011) and longer relapse-free intervals (log-rank chi(2) = 4.04; p = 0.044). When different types of episodes were analyzed separately, the effect was significant for both the number of patients who experienced a hypomanic/manic recurrence (chi2 = 5.65; p = 0.017) and the time to such an episode (log-rank chi2 = 5.84; p = 0.015). The differences in preventing depressive and mixed episodes were not significant.



A psychoeducation group intervention for the caregivers of bipolar patients is a useful adjunct to usual treatment for the patients in reducing the risk of recurrences, particularly mania and hypomania, in bipolar disorder.
Adjuvant radiotherapy after extrapleural pneumonectomy for mesothelioma. Prospective analysis of a multi-institutional series.

To evaluate survival, locoregional control and toxicity in a series of 56 mesothelioma patients treated from May 2005 to May 2010 with post-operative radiotherapy after extrapleural pneumonectomy (EPP) in three Italian Institutions (Brescia, Florence, and Modena).



Fifty-six patients treated with adjuvant radiotherapy (RT) after EPP were analyzed. Four patients were treated with 3DCRT, 50 with IMRT and two with helical tomotherapy. Forty-five to 50 Gy in 25 fractions were given to the affected hemithorax and to ipsilateral mediastinum, with a simultaneous integrated boost to the sites of microscopically involved margins up to 60 Gy in 20/56 cases.



Three year locoregional control (LRC), distant metastasis free (DMF), disease free (DF), disease specific (DSS) and overall survival (OS) rates are 90%, 66%, 57%, 62%, and 60%, respectively.



Postoperative RT with modern techniques is an effective method to obtain excellent local control and cure rates in mesothelioma patients submitted to EPP.
Ketamine with and without midazolam for gastrointestinal endoscopies in children.

Numerous publications on sedation of and anaesthesia for diagnostic procedures in children prove that no ideal scheme is available. Therefore, we decided to study the protocol with midazolam and ketamine used by nonanaesthetists at our institution. The study aimed to establish the lowest effective starting dose of ketamine and to estimate a difference in the frequency of adverse reactions with or without the use of midazolam as premedication, with special stress on emergence reactions.



During 1 year we prospectively randomised children scheduled for gastrointestinal endoscopies to a first group with and to a second group without midazolam premedication. The starting ketamine dose was increased until the appropriate dissociative state was reached. Physiological functions were closely monitored and adverse reactions noted.



The median age of 201 analysed patients (111 girls, 90 boys) was 8.2 years. The median starting dose of ketamine was 0.97 mg/kg (the group with midazolam premedication) and 0.99 mg/kg TT (without midazolam premedication). Laryngospasm was observed in 6 patients without statistical difference between the 2 groups. All of the adverse reactions were short lasting; they resolved by symptomatic treatment without complications. Emergence reactions during the observation period at the hospital occurred more often in the group sedated with ketamine without midazolam premedication (P=0.02).



: The sedation protocol with ketamine is safe and efficient. The starting dose of ketamine should be at least 1 mg/kg. There is an advantage to the use of midazolam as premedication before ketamine in paediatric patients because the frequency of emergence reactions in hospital was reduced compared with sole ketamine use.
Hepatitis C in haemorrhagic obstetrical emergencies.

To determine the maternal health and fetal outcome in hepatitis C with obstetrical haemorrhagic emergencies.



An observational study.


PLACE AND DURATION OF STUDY
Department of Obstetrics and Gynaecology Unit-I, Liaquat University of Medical and Health Sciences Hospital, Hyderabad, Sindh, from January 2009 to December 2010.



All the women admitted during the study period with different obstetrical haemorrhagic emergencies were included. On virology screening, hepatitis C screening was done on all. The women with non-haemorrhagic obstetrical emergencies were excluded. Studied variables included demographic characteristics, the nature of obstetrical emergency, haemorrhagic conditions and maternal and fetal morbidity and mortality. The data was analyzed on SPSS version 20.



More frequent obstetrical haemorrhagic emergencies were observed with hepatitis C positive in comparison with hepatitis C negative cases including post-partum haemorrhage in 292 (80.88%) and ante-partum haemorrhage in 69 (19.11%) cases. Associated morbidities seen were disseminated intravascular coagulation in 43 (11.91%) and shock in 29 (8.03%) cases with hepatitis C positive. Fetal still birth rate was 37 (10.24%) in hepatitis C positive cases.



Frequency of maternal morbidity and mortality and perinatal mortality was high in obstetrical haemorrhagic emergencies with hepatitis C positive cases.
One-year evolution of ulnar somatosensory potentials after trauma in 365 tetraplegic patients: early prediction of potential upper limb function.

Early prediction of hand function is crucial for efficient rehabilitation of cervical spinal cord injury (cSCI). This study investigated correlations between ulnar somatosensory evoked potentials (ulnar SSEPs) and functional outcome of hand function following acute traumatic cervical cord injury. Neurological assessment of sensory scores and hand function were compared with five ulnar SSEP categories of similar persistence and quality in 365 patients throughout the first year after cSCI. Of the 365 patients, 218 (68%) exhibited ulnar SSEP potentials at any one stage during the year, and in 147 patients (40.3%) ulnar SSEPs were obtainable at every assessment stage. While ulnar SSEP latency and amplitude assessments remained largely unchanged over time in the majority of patients, hand function improved remarkably during the first year following cSCI. One year outcome of hand function was predetermined by ulnar SSEP category due to distinct differences in the ulnar SSEP parameters. Additionally, an early prognostic group allocation by ulnar SSEP criteria at the first assessment stage within 4 weeks after spinal trauma allowed reliable prediction of hand function outcome after 1 year. We conclude that early assessment of ulnar SSEP as a non-invasive and objective neurophysiological test is a valuable marker of prospective hand function and independence 1 year after cSCI. This could be most relevant for planning neurorehabilitation, and in prospective clinical SCI trials.
Smell identification test as a treatment response marker in patients with Alzheimer disease receiving donepezil.

Olfactory dysfunction, impaired odor identification in particular, is known to occur in Alzheimer disease (AD). The entorhinal cortex and the olfactory bulb, critical areas for olfactory function, are rich in acetylcholine, the neurotransmitter implicated in AD pathology and treatment. In view of the common anatomical substrate, we aimed to determine whether performance on an olfaction test can be used as a clinical marker for monitoring the efficacy of donepezil in elderly people with AD.



Twenty-five participants with mild to moderate AD, planned for donepezil treatment, were recruited from mental health services for older adults in this open-labeled study. Assessments before commencing donepezil included Mini-Mental State Examination, Neuropsychiatric Inventory, Bristol Activities of Daily Living, and the University of Pennsylvania Smell Identification Test. After 3 months of treatment, the primary outcome measure, the Clinician Interview Based Impression of Change plus caregiver input (CIBIC-plus), was completed, and the baseline assessments were repeated.



Eighteen patients continued to receive donepezil at follow-up. The CIBIC-plus outcome correlated with changes in University of Pennsylvania Smell Identification Test and Bristol Activities of Daily Living scores from the baseline (r = 0.7, P < 0.01). In addition, it was the change in smell identification function after treatment that best predicted CIBIC-plus outcome (P < 0.05) on ordinal regression analysis.



Smell identification function could be useful as a clinical measure to assess treatment response with donepezil in AD. This is a nonblind uncontrolled study, and the outcome indicates the need for a controlled study.
Cost-effectiveness of clozapine compared with conventional antipsychotic medication for patients in state hospitals.

An open-label, randomized controlled trial compared clozapine with physicians'-choice medications among long-term state hospital inpatients in Connecticut. The goal was to examine clozapine's cost-effectiveness in routine practice for people experiencing lengthy hospitalizations.



Long-stay patients with schizophrenia in a state hospital were randomly assigned to begin open-label clozapine (n = 138) or to continue receiving conventional antipsychotic medications (n = 89). We interviewed study participants every 4 months for 2 years to assess psychiatric symptoms and functional status, and we collected continuous measures of prescribed medications, service utilization, and other costs. We used both parametric and nonparametric techniques to examine changes in cost and parametric analyses to examine changes in effectiveness. We used bootstrap techniques to estimate incremental cost-effectiveness ratios and create cost-effectiveness acceptability curves.



Both groups incurred similar costs during the 2-year study period, with a trend for clozapine to be less costly than usual care in the second study year. Clozapine was more effective than usual care on many but not all measures. With the use of effectiveness measures that favored clozapine (extrapyramidal side effects, disruptiveness), bootstrap techniques indicated that, even when a payer is unwilling to incur any additional cost for gains in effectiveness, the probability that clozapine is more cost-effective than usual care is at least 0.80. These findings were not as evident when outcomes where clozapine was not clearly superior (psychotic symptoms, weight gain) were examined.



Clozapine demonstrated cost-effectiveness on some but not all measures of effectiveness when the alternative was a range of conventional antipsychotic medications.
Reduced-Intensity Transplantation for Lymphomas Using Haploidentical Related Donors Versus HLA-Matched Sibling Donors: A Center for International Blood and Marrow Transplant Research Analysis.

Related donor haploidentical hematopoietic cell transplantation (Haplo-HCT) using post-transplantation cyclophosphamide (PT-Cy) is increasingly used in patients lacking HLA-matched sibling donors (MSD). We compared outcomes after Haplo-HCT using PT-Cy with MSD-HCT in patients with lymphoma, using the Center for International Blood and Marrow Transplant Research registry.



We evaluated 987 adult patients undergoing either Haplo-HCT (n = 180) or MSD-HCT (n = 807) following reduced-intensity conditioning regimens. The haploidentical group received graft-versus-host disease (GVHD) prophylaxis with PT-Cy with or without a calcineurin inhibitor and mycophenolate. The MSD group received calcineurin inhibitor-based GVHD prophylaxis.



Median follow-up of survivors was 3 years. The 28-day neutrophil recovery was similar in the two groups (95% v 97%; P = .31). The 28-day platelet recovery was delayed in the haploidentical group compared with the MSD group (63% v 91%; P = .001). Cumulative incidence of grade II to IV acute GVHD at day 100 was similar between the two groups (27% v 25%; P = .84). Cumulative incidence of chronic GVHD at 1 year was significantly lower after Haplo-HCT (12% v 45%; P < .001), and this benefit was confirmed on multivariate analysis (relative risk, 0.21; 95% CI, 0.14 to 0.31; P < .001). For Haplo-HCT v MSD-HCT, 3-year rates of nonrelapse mortality (15% v 13%; P = .41), relapse/progression (37% v 40%; P = .51), progression-free survival (48% v 48%; P = .96), and overall survival (61% v 62%; P = .82) were similar. Multivariate analysis showed no significant difference between Haplo-HCT and MSD-HCT in terms of nonrelapse mortality (P = .06), progression/relapse (P = .10), progression-free survival (P = .83), and overall survival (P = .34).



Haplo-HCT with PT-Cy provides survival outcomes comparable to MSD-HCT, with a significantly lower risk of chronic GVHD.
Women's perspectives and experiences on screening for osteoporosis (Risk-stratified Osteoporosis Strategy Evaluation, ROSE).

This study aimed to investigate women's perspectives and experiences with screening for osteoporosis. Focus groups and individual interviews were conducted. Three main themes emerged: knowledge about osteoporosis, psychological aspects of screening, and moral duty. Generally, screening was accepted due to life experiences, self-perceived risk, and the preventive nature of screening.



The risk-stratified osteoporosis strategy evaluation (ROSE) study is a randomized prospective population-based trial investigating the efficacy of a screening program to prevent fractures in women aged 65-80 years. It is recommended by the World Health Organization that a set of criteria are met before a screening program is implemented. This sub-study aims to investigate women's perspectives and experiences with the ROSE screening program in relation to the patient-related criteria recommended by the World Health Organization.



A qualitative study was carried out involving 31 women by way of 8 focus group interviews and 11 individual interviews. Principles from critical psychology guided the analysis.



Women's perspectives and experiences with the screening program were described by three main themes: knowledge about osteoporosis, psychological aspects of screening, and moral duty. The women viewed the program in the context of their everyday life and life trajectories. Age, lifestyle, and knowledge about osteoporosis were important to how women ascribed meaning to the program, how they viewed the possibilities and limitations, and how they rationalized their actions and choices. The women displayed limited knowledge about osteoporosis and its risk factors. However, acceptance was based on prior experience, perceived risk, and evaluation of preventive measures. To be reassured or concerned by screening was described as important issues, as well as the responsibility for health-seeking behaviour.



In general, the women accepted the screening program. No major ethical reservations or adverse psychological consequences were detected. Only a minority of women declined screening participation due to a low perceived risk of osteoporosis.