nils-herrmann/clean_scirepeval huggingface dataset:
Phase II study of irinotecan and cisplatin with concurrent split-course radiotherapy in limited-disease small cell lung cancer

Irinotecan and cisplatin are one of active regimens for patients with extensive-stage small cell lung cancer (SCLC). To determine the efficacy and toxicity of irinotecan and cisplatin with concurrent split-course thoracic radiotherapy in limited-disease (LD) SCLC, we conducted a phase II study. Thirty-four patients fulfilling the following eligibility criteria were enrolled: chemotherapy-naïve, good performance status (PS 0–1), age ≤75, LD-SCLC, and adequate organ function. The patients received irinotecan 40 mg/m2 i.v. on days 1, 8, and 15, and cisplatin 60 mg/m2 i.v. on day 1. Four cycles of chemotherapy were repeated every 4 weeks. Split-course thoracic radiotherapy of once-daily 2 Gy/day commenced on day 2 of each chemotherapy cycle, with 26 and 24 Gy administered in the first and second cycles, respectively. Thirty-four patients were eligible and assessable for response, toxicity, and survival. Patients’ characteristics were as follows: male/female = 29/5; PS 0/1 = 18/16; median age (range) = 67 (50–73); and stage IB/IIA/IIB/IIIA/IIIB = 2/2/3/16/11. The overall response was 100 % (CR 8, PR 26). Grade 4 leukopenia, neutropenia, grade 3–5 pneumonitis, diarrhea, and esophagitis occurred in 24, 38, 6, 3, and 0 %, respectively. There were 2 treatment-related deaths from pneumonitis. The median time to tumor progression was 14.3 months. The median overall survival time and the 2- and 5-year survival rates were 44.5 months, 66.7 and 46.1 %, respectively. No tumor progression was observed in patients with CR. Irinotecan plus cisplatin with concurrent split-course thoracic radiotherapy was effective and tolerable in untreated LD-SCLC.
Well-being therapy of generalized anxiety disorder.

There is increasing awareness that the goal of treatment in generalized anxiety disorder (GAD) should not simply be a response, but restoration of normal function. The aim of this study was to apply a novel psychotherapeutic approach for increasing the level of remission in GAD.



Twenty patients with DSM-IV GAD devoid of comorbid conditions were randomly assigned to 8 sessions of cognitive behavioral therapy (CBT) or the sequential administration of 4 sessions of CBT followed by other 4 sessions of well-being therapy (WBT). Assessment methods included the Anxiety and Depression Scales of Paykel's Clinical Interview for Depression,  A one-year follow-up was undertaken.



Significant advantages of the CBT-WBT sequential combination over CBT only were observed with both observer and self-rated methods after treatment. Such gains were maintained at follow-up.



These preliminary results suggest the feasibility and clinical advantages of adding WBT to the treatment of GAD. They lend support to a sequential use of treatment components for achieving a more sustained recovery.
Clinical and analytical evaluation of an enzyme immunoassay for myelin basic protein in cerebrospinal fluid.

RIA of myelin basic protein (MBP) in cerebrospinal fluid (CSF) is commonly used as a biochemical marker of demyelination in patients with multiple sclerosis (MS). Our aim was to develop a sufficiently sensitive ELISA for MBP and evaluate it clinically in patients with MS.



The ELISA used anti-bovine MBP antibody coated on plates and biotinylated anti-MBP antibody. The bound antibody complex was quantified with streptavidin-horseradish peroxidase. MBP was determined in CSF from 84 MS patients and 55 patients with other neurological diseases.



The respective within- and between-assay CVs were 4.7% and 7.2% at 200 ng/L, and 6. 3% and 8.8% at 2000 ng/L. The detection limit was 30 ng/L. Most of the MS patients with acute exacerbations had markedly increased MBP in the CSF. Longitudinal studies of six MS patients with recurrent exacerbation confirmed this observation. MBP concentrations from 78 MS patients, as tested with our ELISA, correlated well with those obtained by RIA (r = 0.9; P: <0.01), but the detection limit of the ELISA was much lower than that of the RIA.



This convenient ELISA with higher sensitivity than the existing assays is a suitable routine assay that provides a diagnostic indicator of myelin breakdown in the central nervous system; moreover, it is an excellent indicator of MS disease activity.
Hylan versus corticosteroid versus placebo for treatment of basal joint arthritis: a prospective, randomized, double-blinded clinical trial.

Conservative, nonsurgical therapies for basal joint osteoarthritis, such as thumb spica splinting and intra-articular corticosteroid injections, remain the mainstays for symptomatic treatment. This study compares intra-articular hylan, corticosteroid, and placebo injections with regard to pain relief, strength, symptom improvement, and metrics of manual function in a randomized, controlled, double-blinded study.



Sixty patients with basal joint arthritis were randomized to receive 2 intra-articular hylan injections 1 week apart, 1 placebo injection followed by 1 corticosteroid injection 1 week later, or 2 placebo injections 1 week apart. Patients were evaluated at 2, 4, 12, and 26 weeks and assessed with Visual Analog Scale pain scores, strength measures, difference scores, Disabilities of the Arm, Shoulder, and Hand (DASH) scores, and range of motion measurements.



All groups reported pain relief at 2 weeks. The steroid and placebo groups had significantly less pain at week 4 compared with baseline, but this effect disappeared by week 12. Only hylan injections continued to provide pain relief at 12 and 26 weeks compared with baseline. There were no significant differences in pain between groups at any time. At 12 and 26 weeks, the hylan group had improved grip strength compared with baseline, whereas the steroid and placebo groups were weaker. At 4 weeks, the steroid group reported in the difference score a greater improvement in symptoms (68%) compared with the hylan (44%) and placebo (50%) groups. Whereas at 26 weeks the hylan group reported the largest improvement in symptoms (68%), this was not statistically different from the placebo (47%) and steroid (58%) groups. There were no significant differences in Disabilities of the Arm, Shoulder, and Hand scores or range of motion among the groups. There were no complications from any injection.



There were no statistically significant differences among hylan, steroid, and placebo injections for most of the outcome measures at any of the follow-up time points. However, based on the durable relief of pain, improved grip strength, and the long-term improvement in symptoms compared with preinjection values, hylan injections should be considered in the management of basal joint arthritis of the thumb.



Therapeutic I.
Assessment of cardiovascular disease in the donkey: clinical, echocardiographic and pathological observations.

The Donkey Sanctuary (DS) owns 3500-4000 donkeys, estimated to be about 35 per cent of the UK population. Although postmortem surveys suggest a high prevalence of cardiovascular disease in donkeys, there is sparse clinical information about cardiovascular examination findings and echocardiographic findings in health and disease. In this cross-sectional study, auscultation findings were recorded, and in a subset of donkeys, echocardiography was used to screen for structural and functional cardiac disease. 202 donkeys were examined; 117 geldings and 85 females. Heart sounds S1 and S2 were detected in all donkeys, but none had audible S3. S4 was detected in nine (4.5 per cent; significantly older than those without S4; P<0.001). A heart murmur was detected in four donkeys. Echocardiography identified these to be due to a ventricular septal defect in one, and aortic regurgitation in three. An additional 43 donkeys had echocardiography. A further 10 donkeys were identified to have aortic insufficiency, but no other valvular regurgitation. 76/202 donkeys subsequently underwent postmortem examination. Three showed degenerative aortic valve changes. One donkey had nodular lesions in the intima of proximal aorta and sinus of Valsalva. Histopathology showed multifocal chronic nodular eosinophilic arteritis, consistent with verminous arteritis. The DS pathology database identified other similar cases.
Impact of more intensive written information in patients having radical radiation therapy: results of a prospective randomized phase III trial.

A diagnosis of malignancy and its treatment is a very stressful time for patients and their families. This study was conducted to determine the impact of more intensive written information on patients' anxiety levels. The secondary aim was to determine the impact of this information on patients' satisfaction levels.



This prospective randomized trial consisted of patients with a pathological diagnosis of cancer having radical radiotherapy (RT). Patients were randomized to receive the more intensive information (including written information and a telephone call from the research nurse) or not to receive the more intensive information at the time of their initial consultation with the radiation oncologist. Study questionnaires measuring anxiety (STAI form) were completed prior to their first consultation (baseline) at the time of simulation (pre-RT) and at the completion of radiotherapy. A second questionnaire assessing satisfaction with the information given (ISQ) was completed at the time of simulation prior to commencing RT.



One hundred and ninety-four patients were enrolled in the study. The mean age of the patients was 58.5 years and 70% of patients were female. Breast cancer (67%) was the commonest cancer. One hundred and two patients were randomized to receive the intensive information package and 92 patients received the standard consultation. There was no significant difference in mean State or Trait anxiety scores between any of the time intervals and no difference between the two information groups. There was no significant difference between the groups with regard to mean satisfaction scores with the overall information given, nor with any individual question. The satisfaction scores with lifestyle information given were lower than those for any other type of information in both randomization arms.



More intensive information did not significantly change patients' anxiety scores or satisfaction levels. The patients were generally very satisfied with the information they received but less satisfied with the information on lifestyle issues.
High Dose Chemotherapy with Autologous Stem Cell Rescue in Adults with Malignant Primary Brain Tumors

High dose chemotherapy (HDCT) with autologous (bone marrow or peripheral blood) stem cell rescue (ASCR) has had success in the treatment of some malignant pediatric brain tumors. We report a series of adults enrolled in one of three HDCT and ASCR protocols for malignant primary brain tumors. Overall toxic mortality was 18%; chemotherapy regimen, tumor type, and prior treatment did not predict transplant-related mortality. Patients over the age of 30 had a higher rate of toxic mortality. Patients with recurrent medulloblastoma had a significant improvement in long-term survival (median: 34 months) as compared with historical reports; two patients with glioblastoma survive beyond four years without progression, but overall, a significant improvement in long-term survival could not be demonstrated for malignant gliomas.
Outcome of in vitro fertilization/intracytoplasmic sperm injection after laparoscopic cystectomy for endometriomas.

To assess the impact of prior unilateral or bilateral endometrioma cystectomy on controlled ovarian hyperstimulation (COH) and intracytoplasmic sperm injection (ICSI) outcome.



Retrospective case-control study.



Department of Obstetrics and Gynecology, School of Medicine, Hacettepe University, Ankara, Turkey.



Fifty-seven consecutive infertile patients were enrolled who had previously undergone unilateral (n = 34) or bilateral (n = 23) laparoscopic cystectomy for endometriomas more than 3 cm in diameter and underwent ICSI. The control group consisted of 99 patients with tubal factor infertility.



Controlled ovarian hyperstimulation and ICSI.



Cycle cancellation rate, number of oocytes, fertilization rate, embryo quality, clinical pregnancy rate (PR), and implantation rate.


RESULT(S)
The mean number of oocytes, metaphase II oocytes, and two-pronucleated oocytes were significantly lower in the bilateral cystectomy group compared to the unilateral cystectomy and control groups. However, all other parameters, including fertilization rate, the mean number of embryos transferred, the mean number of grade 1 embryos transferred, the clinical PR per embryo transfer, and implantation rate, were comparable among the three groups. Within the unilateral cystectomy group, the mean number of oocyte retrieved from the operated site was significantly less than in the contralateral nonoperated site.


CONCLUSION(S)
Laparoscopic endometrioma cystectomy does reduce the ovarian reserve. However, diminished ovarian reserve does not translate into impaired pregnancy outcome.
The impact of the lung allocation score on short-term transplantation outcomes: a multicenter study.

The lung allocation score restructured the distribution of scarce donor lungs for transplantation. The algorithm ranks waiting list patients according to medical urgency and expected benefit after transplantation. The purpose of this study was to evaluate the impact of the lung allocation score on short-term outcomes after lung transplantation.



A multicenter retrospective cohort study was performed with data from 5 academic medical centers. Results of patients undergoing transplantation on the basis of the lung allocation score (May 4, 2005 to May 3, 2006) were compared with those of patients receiving transplants the preceding year before the lung allocation score was implemented (May 4, 2004, to May 3, 2005).



The study reports on 341 patients (170 before the lung allocation score and 171 after). Waiting time decreased from 680.9 +/- 528.3 days to 445.6 +/- 516.9 days (P < .001). Recipient diagnoses changed with an increase in idiopathic pulmonary fibrosis and a decrease in emphysema and cystic fibrosis (P = .002). Postoperatively, primary graft dysfunction increased from 14.1% (24/170) to 22.9% (39/171) (P = .04) and intensive care unit length of stay increased from 5.7 +/- 6.7 days to 7.8 +/- 9.6 days (P = .04). Hospital mortality and 1-year survival were the same between groups (5.3% vs 5.3% and 90% vs 89%, respectively; P > .6)



This multicenter retrospective review of short-term outcomes supports the fact that the lung allocation score is achieving its objectives. The lung allocation score reduced waiting time and altered the distribution of lung diseases for which transplantation was done on the basis of medical necessity. After transplantation, recipients have significantly higher rates of primary graft dysfunction and intensive care unit lengths of stay. However, hospital mortality and 1-year survival have not been adversely affected.
Ginkgolide B complex efficacy for brief prophylaxis of migraine in school-aged children: an open-label study

Primary headaches (migraines and tension-types headaches) are very common in school-aged children. Ginkgolide B, a herbal constituent extract from Ginkgo biloba tree leaves, was considered as a promising pharmacological aid for the treatment of migraine in adult patients because of its modulation of the glutamatergic transmission in the CNS and on antiplatelet activating factor (PAF). The aim of study is to verify the effectiveness and safety of association of Ginkgolide B/Coenzyme Q10/Riboflavin/Magnesium complex for brief prophylaxis in a population of school-aged children with migraine. In our sample after 3 months of treatment with association of Ginkgolide B/CoenzymeQ10/Riboflavin/Magnesium complex, the mean frequency per month of migraine was significantly decreased (9.71 ± 4.33 vs. 4.53 ± 3.96 attacks; p < 0.001). Our findings suggest that in childhood headache management, the use of alternative treatments must be considered not to evoke a placebo effect, but as soft therapy without adverse reactions.
Supplementary guanfacine hydrochloride as a treatment of attention deficit hyperactivity disorder in adults: A double blind, placebo-controlled study

The purpose of this study was to examine the efficacy of an extended release guanfacine hydrochloride supplement relative to a placebo supplement in adults (19-62) with ADHD and a sub-optimal response to a stimulant-only treatment program. The study's primary outcome measures were the Attention Deficit Hyperactivity Disorder Rating Scale and the Clinical Global Impression - Severity. Twenty-six adults who met criteria for attention deficit hyperactivity disorder and sub-optimal functioning were randomly assigned to supplement their existing psychostimulant treatment regimen with either a titrated dose (1-6mg) of extended release guanfacine hydrochloride or a matching placebo for a 10-week trial. The data were analyzed with standard mixed model analysis of variance procedures, and participants in both the investigational agent group and the placebo group showed statistically significant improvement in their symptoms and functioning over the course of the trial. The treatments did not differ in terms of their efficacy, safety, or tolerability. Although these results do suggest that both treatments were associated with clinical improvement, the possible impacts of socially desirable responding and regression to the mean on these results are discussed.
Individualized Tumor Response Testing for Prediction of Response to Paclitaxel and Cisplatin Chemotherapy in Patients with Advanced Gastric Cancer

The purpose of our study was to determine the most accurate analytic method to define in vitro chemosensitivity, using clinical response as reference standard in prospective clinical trial, and to assess accuracy of adenosine triphosphate-based chemotherapy response assay (ATP-CRA). Forty-eight patients with chemo-naïve, histologically confirmed, locally advanced or metastatic gastric cancer were enrolled for the study and were treated with combination chemotherapy of paclitaxel 175 mg/m(2) and cisplatin 75 mg/m(2) for maximum of six cycles after obtaining specimen for ATP-CRA. We performed the receiver operator characteristic curve analysis using patient responses by WHO criteria and ATP-CRA results to define the method with the highest accuracy. Median progression free survival was 4.2 months (95% confidence interval [CI]: 3.4-5.0) and median overall survival was 11.8 months (95% CI: 9.7-13.8) for all enrolled patients. Chemosensitivity index method yielded highest accuracy of 77.8% by ROC curve analysis, and the specificity, sensitivity, positive and negative predictive values were 95.7%, 46.2%, 85.7%, and 75.9%. In vitro chemosensitive group showed higher response rate (85.7% vs. 24.1%) (P=0.005) compared to chemoresistant group. ATP-CRA could predict clinical response to paclitaxel and cisplatin chemotherapy with high accuracy in advanced gastric cancer patients. Our study supports the use of ATP-CRA in further validation studies.
Safety and efficacy of extracorporeal shock wave myocardial revascularization therapy for refractory angina pectoris.

To assess the safety and efficacy of extracorporeal shockwave myocardial revascularization (ESMR) therapy in treating patients with refractory angina pectoris.



A single-arm multicenter prospective trial to assess safety and efficacy of the ESMR therapy in patients with refractory angina (class III/IV angina) was performed. Screening exercise treadmill tests and pharmacological single-photon emission computed tomography (SPECT) were performed for all patients to assess exercise capacity and ischemic burden. Patients were treated with 9 sessions of ESMR to ischemic areas over 9 weeks. Efficacy end points were exercise capacity by using treadmill test as well as ischemic burden on pharmacological SPECT at 4 months after the last ESMR treatment. Safety measures included electrocardiography, echocardiography, troponin, creatine kinase, and brain natriuretic peptide testing, and pain questionnaires.



Fifteen patients with medically refractory angina and no revascularization options were enrolled. There was a statistically significant mean increase of 122.3±156.9 seconds (38% increase compared with baseline; P=.01) in exercise treadmill time from baseline (319.8±157.2 seconds) to last follow-up after the ESMR treatment (422.1±183.3 seconds). There was no improvement in the summed stress perfusion scores after pharmacologically induced stress SPECT at 4 months after the last ESMR treatment in comparison to that at screening; however, SPECT summed stress score revealed that untreated areas had greater progression in ischemic burden vs treated areas (3.69±6.2 vs 0.31±4.5; P=.03). There was no significant change in the mean summed echo score from baseline to posttreatment (0.4±5.1; P=.70). The ESMR therapy was performed safely without any adverse events in electrocardiography, echocardiography, troponins, creatine kinase, or brain natriuretic peptide. Pain during the ESMR treatment was minimal (a score of 0.5±1.2 to 1.1±1.2 out of 10).



In this multicenter feasibility study, ESMR seems to be a safe and efficacious treatment for patients with refractory angina pectoris. However, larger sham-controlled trials will be required to confirm these findings.
Pilot study of losartan for pulmonary hypertension in chronic obstructive pulmonary disease

Morbidity in COPD results from a combination of factors including hypoxia-induced pulmonary hypertension, in part due to pulmonary vascular remodelling. Animal studies suggest a role of angiotensin II and acute studies in man concur. Whether chronic angiotensin-II blockade is beneficial is unknown. We studied the effects of an angiotensin-II antagonist losartan, on haemodynamic variables, exercise capacity and symptoms.



This was a double-blind, randomized, parallel group, placebo- controlled study of 48 weeks duration. Forty patients with COPD and pulmonary hypertension (Tran tricuspid pressure gradient (TTPG) = 30 mmHg) were randomised to losartan 50 mg or placebo. Changes in TTPG were assessed at 3, 6 and 12 months.



There was a trend for TTPG to increase in the placebo group (baseline 43.4 versus 48.4 mmHg at endpoint) and stay constant in the losartan group (baseline 42.8 versus 43.6 mmHg). More patients in the losartan group (50%) than in the placebo group (22%) showed a clinically meaningful reduction in TTPG at any timepoint; these effects seemed more marked in patients with higher baseline TTPG. There were no clear improvements in exercise capacity or symptoms.



In this 12-month pilot study, losartan 50 mg had no statistically significant beneficial effect on TTPG, exercise capacity or symptoms in pulmonary hypertension secondary to obstructive disease. A sub-group of patients with higher TTPG may benefit.