nils-herrmann/clean_scirepeval huggingface dataset:
Buprenorphine treatment of refractory depression.

Opiates were used to treat major depression until the mid-1950s. The advent of opioids with mixed agonist-antagonist or partial agonist activity, with reduced dependence and abuse liabilities, has made possible the reevaluation of opioids for this indication. This is of potential importance for the population of depressed patients who are unresponsive to or intolerant of conventional antidepressant agents. Ten subjects with treatment-refractory, unipolar, nonpsychotic, major depression were treated with the opioid partial agonist buprenorphine in an open-label study. Three subjects were unable to tolerate more than two doses because of side effects including malaise, nausea, and dysphoria. The remaining seven completed 4 to 6 weeks of treatment and as a group showed clinically striking improvement in both subjective and objective measures of depression. Much of this improvement was observed by the end of 1 week of treatment and persisted throughout the trial. Four subjects achieved complete remission of symptoms by the end of the trial (Hamilton Rating Scale for Depression scores < or = 6), two were moderately improved, and one deteriorated. These findings suggest a possible role for buprenorphine in treating refractory depression.
Zinc for attention-deficit/hyperactivity disorder: placebo-controlled double-blind pilot trial alone and combined with amphetamine.

To explore effects of zinc supplementation in American children with attention-deficit/hyperactivity disorder (ADHD). Mideastern trials reported significant benefit from 13-40 mg elemental zinc as the sulfate.



We randomly assigned 52 children aged 6-14 with DSM-IV ADHD to zinc supplementation (15 mg every morning [qAM] or two times per day [b.i.d.] as glycinate, n = 28) or matched placebo (n = 24) for 13 weeks: 8 weeks monotherapy and then 5 weeks with added d-amphetamine (AMPH). AMPH dose was weight-standardized for 2 weeks and then clinically optimized by week 13. Zinc glycinate was chosen as having less gastrointestinal discomfort than sulfate. Hypotheses were that zinc would improve inattention more than placebo by effect size of d > 0.25 at 8 weeks; zinc+AMPH would improve ADHD symptoms more than placebo+AMPH by d > 0.25, and optimal dose of AMPH with zinc would be 20% lower than with placebo. An interim analysis requested by the National Institute of Mental Health resulted in an increased dosage, so that 20 received 15 mg/day qAM and 8 received 30 mg/day (15 mg b.i.d.)



Only the third hypothesis was upheld: Optimal mg/kg AMPH dose with b.i.d. zinc was 37% lower than with placebo. Other clinical outcomes were equivocal, sometimes favoring zinc, sometimes placebo, but objective neuropsychological measures mostly favored b.i.d. zinc (d = 0.36-0.7). Safety tests and adverse events were not different between groups. Copper and iron blood indices were not impaired by 8 weeks of 30 mg/day zinc.



Doses up to 30 mg/day of zinc were safe for at least 8 weeks, but clinical effect was equivocal except for 37% reduction in amphetamine optimal dose with 30 mg/day zinc (not with 15 mg). Possible reasons for difference from mideastern reports include endemic diets, population genetics, relative rate of zinc deficiency, difference in background nutrition, insufficient dosage or absorption, or wrong anion (sulfate may be necessary for reported benefit). Dose may be especially important: All visually impressive advantages over placebo appeared only with 15 mg b.i.d. rather than once a day. Future research should use larger doses than 15 mg/day, provide a basic recommended daily allowance/intake multivitamin/mineral supplement for all to standardize background nutrition, select participants for low zinc, and consider the issue of anion interaction.
Otlertuzumab (TRU-016), an anti-CD37 monospecific ADAPTIR(™) therapeutic protein, for relapsed or refractory NHL patients.

CD37 is cell surface tetraspanin present on normal and malignant B cells. Otlertuzumab (TRU-016) is a novel humanized anti-CD37 protein therapeutic. Patients with relapsed or refractory follicular non-Hodgkin lymphoma (FL), mantle cell lymphoma (MCL), or Waldenström's macroglobulinaemia (WM) received otlertuzumab at 20 mg/kg administered intravenously once a week for up to 8 weeks followed by 4 monthly doses. Sixteen patients were treated; median age was 62·5 years (range, 41-81), and median number of prior regimens was 4 (range, 1-7). Twelve patients were refractory to prior treatment, 5 were refractory to rituximab. The mean terminal half-life was 9·5 days. Lymph node reduction of ≥50% by computerized tomography scan measurements was seen in 3 of 12 patients, including one FL patient who had a partial response. One WM patient had a minor response. The most frequent adverse events were neutropenia, fatigue, nausea, thrombocytopenia, diarrhoea, and peripheral oedema; most were grade 1/2. Otlertuzumab treatment appears to have been well tolerated by the patients in this study. Clinical activity was observed in this small heterogeneous cohort of highly refractory, heavily pretreated B-cell non-Hodgkin lymphoma patients. These data suggest that further clinical investigation in non-Hodgkin lymphoma is warranted.
Prevention of osteoporosis with nasal salmon calcitonin: Effect of anti-salmon calcitonin antibody formation

The amino acid sequence of salmon calcitonin (SCT) differs considerably from that of the human hormone and specific antibodies (Ab) develop in a significant proportion of patients after parenteral or nasal administration of SCT. Controversy remains regarding the functional importance of these Ab. We report on the development of specific anti-SCT Ab in a population of postmenopausal women receiving nasal SCT for prevention of postmenopausal bone loss, and compare the effects of nasal SCT in women with or without Ab. Thirty-nine per cent of women developed Ab after 6 months of treatment with SCT, 52% after 12 months, and 61% after 18 and 24 months. After 24 months the AB titre was 3.47−17.7×10−9 M/l (mean ±SD: 13.3±3.1×10−9 M/l). No significant differences appeared between the changes in lumbar bone mineral density (BMD) measured in the whole population (n=44) (mean±SD: + 1.06±3.9%), the patients without Ab (n=17) (+0.05±3.7%) or in those with Ab (n=27) (+1.7±4.6%). During the same period, a control population randomly assigned to a 500 mg/day calcium intake showed a significant loss of lumbar BMD (−4.57±4.9%) (p<0.01). In conclusion, in healthy postmenopausal women nasal SCT seems to maintain the same preventive effect against bone loss whether or not Ab are present.
The Indian Spice Turmeric Delays and Mitigates Radiation-Induced Oral Mucositis in Patients Undergoing Treatment for Head and Neck Cancer: An Investigational Study.

Radiation-induced oral mucositis is an acute morbidity seen in patients undergoing treatment for head and neck cancers. In this study, we evaluated the efficacy of turmeric in preventing radiation-induced mucositis.



This was a single-blinded, randomized, controlled clinical trial and was conducted with head and neck cancer patients requiring 70 Gy of radiation or chemoradiotherapy (daily radiotherapy plus carboplatin once a week). Eligible patients (n = 80) were randomly assigned to receive either turmeric gargle (n = 40) or povidone-iodine ([n = 40] active comparator condition) during chemo/radiotherapy during the period of treatment. Oral mucositis was assessed using the RTOG (Radiation Therapy Oncology Group) grading system before the start, during, and at the end of the treatment by an investigator unaware of the treatment. The primary endpoint of this study was the incidence of mucositis every week during the 7-week period. The secondary endpoint was the effect of turmeric gargle on the incidence of treatment breaks, loss of scheduled treatment days, and decrease in body weight at the end of the treatment.



This study clearly suggests that when compared with the cohorts using povidone-iodine gargle, the group using turmeric as a mouthwash had delayed and reduced the levels of radiation-induced oral mucositis and was statistically significant at all time points (P< 0.001 toP< 0.0001). Additionally, the cohorts using turmeric had decreased intolerable mucositis (P< 0.001) and lesser incidence of treatment breaks in the first half of the treatment schedule before 4 weeks (P< 0.01) and reduced change in body weight (P< 0.001).



Gargling with turmeric by head and neck cancer patients undergoing radiation therapy provided significant benefit by delaying and reducing the severity of mucositis.
Why do hospital mastectomy rates vary? Differences in the decision-making experiences of women with breast cancer

Hospital mastectomy rates vary. This study explores the relationship between mastectomy rates and breast cancer patients’ consultation and decision-making experiences with specialist clinicians.Qualitative semi-structured interviews were conducted with 65 patients from three purposively selected breast units from a single UK region. Patients provided with a choice of breast cancer surgery (breast conservation therapy (BCT) or mastectomy) were purposively recruited from high, medium and low case-mix-adjusted mastectomy rate units.Low mastectomy rate unit patients’ consultation and decision-making experiences were markedly different to those of the medium and high mastectomy rate breast units. Treatment variation was associated with patients’ perception of the most reassuring and least disruptive treatment; the content and style of information provision (equipoise or directed); level of patient participation in decision making; the time and process of decision making and patient autonomy in decision making. The provision of more comprehensive less directive information and greater autonomy, time and support of independent decision making were associated with a lower uptake of BCT.Conclusion:Variation in hospital mastectomy rates was associated with differences in the consultation and decision-making experiences of breast cancer patients. Higher mastectomy rates were associated with the facilitation of more informed autonomous patient decision making.
Web-Based Psychotherapy for Posttraumatic Stress Disorder in War-Traumatized Arab Patients: Randomized Controlled Trial

In recent years, armed conflicts in the Middle East have resulted in high rates of exposure to traumatic events. Despite the increasing demand of mental health care provision, ongoing violence limits conventional approaches of mental health care provision. Internet-based interventions for posttraumatic stress disorder (PTSD) have proved feasible and effective in Western countries, but their applicability and efficacy in war and conflict regions remains unknown.



This study investigated the efficacy of a cognitive behavioral Internet-based intervention for war-traumatized Arab patients, with focus on Iraq.



A total of 159 individuals with PTSD participated in a parallel group randomized trial. Participants were randomly allocated by a computer-generated sequence to a treatment group (n=79) or a waiting list control group (n=80). The treatment group received 2 weekly 45-minute cognitive behavioral interventions via Internet over a 5-week period (10 sessions in total). The primary outcome was recovery from posttraumatic stress symptoms.



Posttraumatic stress symptoms were significantly reduced from baseline to posttreatment (intention-to-treat analysis) in the treatment group relative to the control group (F1,157=44.29, P<.001, d=0.92). Treatment effects were sustained at 3-month follow-up. Completer analysis indicated that 29 of 47 patients (62%) in the treatment group had recovered from posttraumatic stress symptoms at posttreatment (reliable change and Posttraumatic Stress Diagnostic Scale score <20) versus 1 patient (2%) in the control group (OR 74.19, 95% CI 9.93-585.8, P<.001) indicating that the chance of recovering was 74.19 times higher in the treatment than in the control group.



The results indicate, even in unstable and insecure settings with ongoing exposure to human rights violations through war and dictatorships, people with posttraumatic stress symptoms benefit from a cognitive behavioral treatment provided entirely through the Internet. This method of delivery could improve patients' access to humanitarian aid in the form of e-mental health services.
Interfractional variation in bladder volume and its impact on cervical cancer radiotherapy: Clinical significance of portable bladder scanner.

A constant bladder volume (BV) is essential to direct the radiotherapy (RT) of pelvic tumors with precision. The purpose of this study was to investigate changes in BV and their impact on cervical cancer RT and to assess the clinical significance of a portable bladder scanner (BS) in achieving a constant BV.



A standard bladder phantom (133 ml) and measurements of actual urine volume were both used as benchmarks to evaluate the accuracy of the BS. Comparisons of BS with computed tomography (CT), cone-beam CT (CBCT), and an ultrasound diagnostic device (iU22) were made. Twenty-two consecutive patients with cervical cancer treated with external beam radical RT were divided into an experimental group (13 patients) and a control group (9 patients). In the experimental group, the BV was measured multiple times by BS pre-RT until it was consistent with that found by planning CT. Then a CBCT was performed. The BV was measured again immediately post-RT, after which the patient's urine was collected and recorded. In the control group, CBCT only was performed pre-RT. Interfractional changes in BV and their impact on cervical cancer RT were investigated in both groups. The time of bladder filling was also recorded and analyzed.



In measuring the volume of the standard bladder phantom, the BS deviated by 1.4% in accuracy. The difference between the measurements of the BS and the iU22 had no statistical significance (linear correlation coefficient 0.96, P < 0.05). The BV measured by the BS was strongly correlated with the actual urine volume (R = 0.95, P < 0.05), planning CT (R = 0.95, P < 0.05), or CBCT (R = 0.91, P < 0.05). Compared with the BV at the time of CT, its value changed by -36.1% [1 SD (standard deviation) 42.3%; range, -79.1%-29.4%] in the control group, and 5.2% (1 SD 21.5%; range, -13.3%-22.1%) in the experimental group during treatment. The change in BV affected the target position in the superior-inferior (SI) direction but had little or no effect in the anterior-posterior and right-left directions. Based on the collected data, the target displacement in the SI direction was reduced from 2.0 to 0.4 mm, while the CTV-to-PTV (CTV: clinical target volume; PTV: planning target volume) margin in the SI direction was reduced from 11.1 to 6.4 mm. The BV increased by 3.7 ± 1.0 ml/min (range, 1.7-4.7 ml/min), which depended on the amount of water ingested by the patient (R = 0.96, P < 0.05). No correlation was found between the rate of urinary inflow and the patient's body mass. The authors were able to reduce the workload of measuring by using individual patient information including the patient's age, the water-drinking amount, time at which water-drinking began, and patient's diet.



Changes in the BV have an influence on the RT of cervical cancer. A consistent and reproducible BV is acquired by using a portable BS, whereby the target displacement and CTV-to-PTV margin can be both reduced in the SI direction.
Role of Computer Analysis in Gastric Cancer Surgery: Evaluation of the WinEstimate v. 2.5 Computer Program

To identify the group of patients with gastric cancer who can benefit from extensive lymphadenectomy and to offer a rational approach to lymph node dissection, it is important to know the incidence of metastases at each lymph node station. A computer program was developed for assessment of lymph node involvement and survival time in each individual case according to preoperative variables. In patients who have undergone R0 resection with D2 lymphadenectomy, differences between the individual results generated by the computer and the actual data were compared. A cutoff point of 10% in the prediction of metastases was used as a positive result. The computer program made false predictions in 9% of patients for the pN status (3% lower and 6% higher than the actual status). Computerized prediction of 5-year survival was close to the rate calculated by the Kaplan-Meier method (55.5% vs 56.1%). Preoperative computer analysis of patient data and tumor characteristics offers a rational approach to individualizing tumor therapy] where the extent of lymph node dissection is tailored to the type, site, and stage of the tumor, thereby minimizing the disadvantages (morbidity, mortality) associated with the extensive operative procedure.
Comparison of three-day and five-day courses of azithromycin in the treatment of atypical pneumonia

This open, randomised clinical study, conducted from June 1988 to December 1989, included 84 patients with clinical and radiological findings of atypical pneumonia. All patients were treated with a total dose of 1.5 grazithromycin, a new azalide antibiotic. In Group I, azithromycin was administered for three days (500 mg once daily). In Group II, azithromycin was administered for five days (250 mg b.i.d. on day 1, followed by 250 mg once daily on days 2 to 5). Causative pathogens were identified by serological methods. Of the 41 patients in Group I,Mycoplasma pneumoniae, Chlamydia psittaci andCoxiella burnetti were identified in 19, 4 and 3 patients, respectively. In Group II there were 43 patients;Mycoplasma pneumoniae was identified in 24,Chlamydia psittaci in 4 andCoxiella burnetti in 3. Only patients with known causative pathogens were included in the evaluation of clinical efficacy. All patients were clinically cured by day 5; most of the patients became afebrile within 48 h of starting treatment. Side effects were observed in one patient in Group I and in one patient in Group II. The results suggest that a 1.5 g total dose of azithromycin is equally effective when administered as a three- or five-day regimen for the treatment of atypical pneumonia.
Therapeutic bronchoscopic interventions for malignant airway obstruction

There is no definitive consensus about the factors affecting the choice of interventional bronchoscopy in the management of malignant airway obstruction. The present study defines the choice of the interventional bronchoscopic modality and analyzes the factors influencing survival in patients with malignant central airway obstruction. Totally, over 7 years, 802 interventional rigid bronchoscopic procedures were applied in 547 patients having malignant airway obstruction. There was a significant association between the type of stent and the site of the lesion in the present study. Patients with tracheal involvement and/or involvement of the main bronchi had the worst prognosis. The sites of the lesion and endobronchial treatment modality were independent predictors of survival in the present study. The selection of different types of airway stents can be considered on the base of site of the lesion. Survival can be estimated based on the site of the lesion and endobronchial brochoscopic modality used.
Clinical effects of COX–2 inhibitors on cognition in schizophrenia

An activation of pro–inflammatory cytokines in the central nervous system is associated with cognitive disturbances. This process is mediated by prostaglandins and cyclo–oxygenase–2 (COX–2). COX–2 inhibitors have been suggested to show beneficial effects in disorders associated with cognitive disturbance, although clinical effects on cognition have not been shown until today. Data from a schizophrenia study were reevaluated under the aspect whether an effect on the positive and negative syndrome scale (PANSS) factor cognition can be observed during therapy with the COX–2 inhibitor celecoxib add on to risperidone in comparison to riperidone alone. Beside the effect on the PANSS total score, the effect on the cognition factor was the most pronounced using the analysis of covariance compared to all other factors of the PANSS (p <0.06). Although suggestions of basic research led to an expected therapeutic effect of COX–2 inhibitors on cognition, this effect could not yet be shown clinically. In schizophrenia, the effect on cognition contributes to the therapeutic effect of COX–2 inhibitors.
Association of plasma fibrinogen and plasminogen with prognosis of inoperable chronic thromboembolic pulmonary hypertension.

It is unclear whether abnormalities of coagulation or fibrinolysis are associated with disease progression of chronic thromboembolic pulmonary hypertension (CTEPH). The aim of this study was to investigate the association of these factors with the severity and prognosis of CTEPH.



Between 1986 and 2011, plasma fibrinogen and plasminogen were measured in 89 of 106 consecutive patients with inoperable CTEPH (17 men; mean age, 55.9±14.1 years old; mean pulmonary arterial pressure, 44.0±12.4 mmHg) and the association of level with severity and prognosis were also examined. Seventeen patients had high fibrinogen and low plasminogen (medians, ≥291 mg/dl and <101%, respectively). These patients had significantly lower cardiac index (2.26±0.68 vs. 2.70±0.57 L·min(-1)·m(-2), P=0.007), higher pulmonary vascular resistance (PVR; 13.29±7.54 vs. 9.15±4.14 Wood units, P=0.003), and poor survival (5-year survival, 35.3% vs. 88.0%, P<0.001) compared to the other 72 patients. Additional analysis showed significantly poor survival in these patients compared with the other patients who did not have modern therapy. On multivariate analysis plasma fibrinogen, plasminogen and PVR were independent predictors of survival in medically treated patients.



High plasma fibrinogen and low plasminogen are associated with poor survival in CTEPH patients without modern therapy.
Alcohol screening and brief counseling in a primary care hypertensive population: a quality improvement intervention.

To determine the effect of an intervention to improve alcohol screening and brief counseling for hypertensive patients in primary care.



Two-year randomized, controlled trial.



Twenty-one primary care practices across the United States with a common electronic medical record.



To promote alcohol screening and brief counseling. Intervention practices received site visits from study personnel and were invited to annual network meetings to review the progress of the project and share improvement strategies.



Main outcome measures included rates of documented alcohol screening in hypertensive patients and brief counseling administered in those diagnosed with high-risk drinking, alcohol abuse or alcohol dependence. Secondary outcomes included change in blood pressure among patients with these diagnoses.



Hypertensive patients in intervention practices were significantly more likely to have been screened after 2 years than hypertensive patients in control practices [64.5% versus 23.5%; adjusted odds ratio (OR) = 8.1; 95% confidence interval (CI) 1.7-38.2; P < 0.0087]. Patients in intervention practices diagnosed with high-risk drinking, alcohol abuse or alcohol dependence were more likely than those in control practices to have had alcohol counseling documented (50.5% versus 29.6%; adjusted OR = 5.5, 95% CI 1.3-23.3). Systolic (adjusted mean decline = 4.2 mmHg, P = 0.036) and diastolic (adjusted mean decline = 3.3 mmHg, P = 0.006) blood pressure decreased significantly among hypertensive patients receiving alcohol counseling.



Primary care practices receiving an alcohol-focused intervention over 2 years improved rates of alcohol screening for their hypertensive population. Implementation of alcohol counseling for high-risk drinking, alcohol abuse or alcohol dependence also improved and led to changes in patient blood pressures.