nils-herrmann/clean_scirepeval huggingface dataset:
A Novel Indication for Transvenous Lead Extraction: Upgrading Implantable Cardioverter Defibrillator Systems

Technological advances have resulted in the development of dual chamber pacemaker/defibrillator systems with smaller pectoral 'active cans'. Patients now have the option of upgrading from abdominal to pectoral or from single to dual chamber devices. In addition, due to the potential complications which may arise with abandoned ICD leads, extraction of preexisting leads may be preferable.  Twenty consecutive patients (11 males), underwent lead extraction and upgrade, either from an abdominal to a pectoral, or from a single to a dual chamber device. The mean age was 62±18[emsp4 ]years and mean implant duration was 50±14 months. Indications for extraction included lead fracture/malfunction (13), ERI/EOL (2), new SVT/VT (2), long charge times (2), and impending erosion (1). An initial attempt was made to remove the lead with gentle traction. If excessive scar tissue prohibited extraction, then a laser sheath was employed. Reimplantation proceeded following standard protocol. Clinical success was achieved in all patients. Eleven of thirty leads were removed with traction. The remaining 19 leads required removal with the laser sheath. All ICD reimplants were placed in the left pectoral position, of which 10 were dual chamber. The mean defibrillation threshold was 9.5±5.8 Joules. There were no procedure related perforations or deaths. At follow up (13±10 mos.) there were no infections, lead malfunctions or venous thromboses. There were two deaths, both from intractable heart failure.  This study demonstrates that, when indicated, ICD leads can be safely extracted and systems successfully upgraded to take advantage of new technology.
Randomised clinical trial: herbal extract HMPL-004 in active ulcerative colitis - a double-blind comparison with sustained release mesalazine.

Andrographis paniculata is an herbal mixture used to treat inflammatory diseases. An extract of the herb, HMPL-004, inhibits TNF-α and IL-1β, and prevents colitis in animal models.



To determine the efficacy and safety of HMPL-004 in patients with mild-to-moderate ulcerative colitis.



A randomised, double-blind, multicentre, 8-week parallel group study was conducted using HMPL-004 1200 mg/day compared with 4500 mg/day of slow release mesalazine (mesalamine) granules in patients with mild-to-moderately active ulcerative colitis. Disease activity was assessed at baseline and every 2 weeks for clinical response, and at baseline and 8 weeks by colonoscopy.



One hundred and twenty patients at five centres in China were randomised and dosed. Clinical remission and response were seen in 21% and 76% of HMPL-004-treated patients, and 16% and 82% of mesalazine-treated patients. By colonoscopy, remission and response were seen in 28% and 74% of HMPL-004-treated patients and 24% and 71% of mesalazine-treated patients, respectively. There was no significant difference between the two treatment groups.



HMPL-004 may be an efficacious alternative to mesalazine in ulcerative colitis.
A randomized controlled trial of CBT therapy for adults with ADHD with and without medication

Previous studies of psychological treatment in adults with ADHD have not controlled for medication status and include either medicated participants or mixed samples of medicated and unmedicated participants. The objective of this study is to examine whether use of medication improves outcome of therapy.



This was a secondary analysis comparing 23 participants randomized to CBT and Dextroamphetamine vs. 25 participants randomized to CBT and placebo. Both patients and investigators were blind to treatment assignment. Two co-primary outcomes were used: ADHD symptoms on the ADHD-RS-Inv completed by the investigator and improvement in functioning as reported by the patient on the Sheehan Disability Scale.



Both groups showed robust improvement in both symptoms and functioning, but the use of medication did not significantly improve outcome over and above use of CBT and placebo.



This study replicates previous work demonstrating that CBT is an effective treatment for ADHD in adults. Within the limits of this pilot, secondary analysis we were not able to demonstrate that medication significantly augments the outcome of CBT therapy for adults with ADHD. The study was funded by GlaxoSmithKline,
Cost-effectiveness of blended vs. face-to-face cognitive behavioural therapy for severe anxiety disorders: study protocol of a randomized controlled trial

Anxiety disorders are among the most prevalent psychiatric conditions, and are associated with poor quality of life and substantial economic burden. Cognitive behavioural therapy is an effective treatment to reduce anxiety symptoms, but is also costly and labour intensive. Cost-effectiveness could possibly be improved by delivering cognitive behavioural therapy in a blended format, where face-to-face sessions are partially replaced by online sessions. The aim of this trial is to determine the cost-effectiveness of blended cognitive behavioural therapy for adults with anxiety disorders, i.e. panic disorder, social phobia or generalized anxiety disorder, in specialized mental health care settings compared to face-to-face cognitive behavioural therapy. In this paper, we present the study protocol. It is hypothesized that blended cognitive behavioural therapy for anxiety disorders is clinically as effective as face-to-face cognitive behavioural therapy, but that intervention costs may be reduced. We thus hypothesize that blended cognitive behavioural therapy is more cost-effective than face-to-face cognitive behavioural therapy.



In a randomised controlled equivalence trial 156 patients will be included (n = 78 in blended cognitive behavioural therapy, n = 78 in face-to-face cognitive behavioural therapy) based on a power of 0.80, calculated by using a formula to estimate the power of a cost-effectiveness analysis: . Measurements will take place at baseline, midway treatment (7 weeks), immediately after treatment (15 weeks) and 12-month follow-up. At baseline a diagnostic interview will be administered. Primary clinical outcomes are changes in anxiety symptom severity as measured with the Beck Anxiety Inventory. An incremental cost-effectiveness ratio will be calculated to obtain the costs per quality-adjusted life years (QALYs) measured by the EQ-5D (5-level version). Health-economic outcomes will be explored from a societal and health care perspective.



This trial will be one of the first to provide information on the cost-effectiveness of blended cognitive behavioural therapy for anxiety disorders in routine specialized mental health care settings, both from a societal and a health care perspective.
Phase II study of S-1 combined with oxaliplatin as therapy for patients with metastatic biliary tract cancer: influence of the CYP2A6 polymorphism on pharmacokinetics and clinical activity

Advanced biliary cancer is often treated with fluoropyrimidine-based chemotherapy. In this study, we evaluated the efficacy and tolerability of a combination of S-1, an oral fluoropyrimidine prodrug, and oxaliplatin in patients with metastatic biliary cancer.Patients with histologically confirmed metastatic biliary cancer and no history of radiotherapy or chemotherapy were enrolled. Oxaliplatin was administered intravenously (130 mg m−2), followed by 14-day administration of oral S-1 (40 mg m−2 twice daily) with a subsequent 7-day rest period every 21 days. Pharmacokinetic analysis of S-1 was performed at cycle 1. Patients were genotyped for CYP2A6 polymorphisms (*1, *4, *7, *9 or *10), and pharmacokinetic and clinical parameters compared according to the CYP2A6 genotype.In total, 49 patients were evaluated, who received a median of four cycles. The overall response rate was 24.5%. Median progression-free and overall survival was 3.7 and 8.7 months, respectively. The most common haematological grade 3 out of 4 toxicity was neutropenia (14%), while non-hematological grade 3 out of 4 toxicities included anorexia (14%), nausea (12%), asthenia (10%), vomiting (10%), and diarrhoea (4%). Biotransformation of S-1 (AUC0−24 h of 5-fluorouracil/AUC0−24 h of tegafur) was 1.85-fold higher for the *1/*1 group than for the other groups (90% confidence interval 1.37–2.49). Diarrhoea (P=0.0740), neutropenia (P=0.396), and clinical efficacy (response rate, P=0.583; PFS, P=0.916) were not significantly associated with CYP2A6 genotype, despite differences in 5-FU exposure.The combination of S-1 and oxaliplatin appears to be active and well tolerated in patients with metastatic biliary cancer, and thus is feasible as a therapeutic modality. CYP2A6 genotypes are associated with differences in the biotransformation of S-1. However, the impact of the CYP2A6 polymorphism on variations in clinical efficacy or toxicity requires further evaluation.
Across the continuum of attention skills: a twin study of the SWAN ADHD rating scale.

Most behavior checklists for attention problems or attention deficit/hyperactivity disorder (ADHD) such as the Child Behavior Checklist (CBCL) have a narrow range of scores, focusing on the extent to which problems are present. It has been proposed that measuring attention on a continuum, from positive attention skills to attention problems, will add value to our understanding of ADHD and related problems. The Strengths and Weaknesses of ADHD symptoms and Normal behavior scale (SWAN) is such a scale. Items of the SWAN are scored on a seven-point scale, with in the middle 'average behavior' and on the extremes 'far below average' and 'far above average'.



The SWAN and the CBCL were completed by mothers of respectively 560 and 469 12-year-old twin pairs. The SWAN consists of nine DSM-IV items for Attention Deficit (AD) and nine DSM-IV items for Hyperactivity/Impulsivity (HI). The CBCL Attention Problem (AP) scale consists of 11 items, which are rated on a three-point scale.



Children who had a score of zero on the CBCL AP scale can be further differentiated using the SWAN, with variation seen between the average behavior and far above average range. In addition, SWAN scores were normally distributed, rather than kurtotic or skewed as is often seen with other behavioral checklists. The CBCL AP scale and the SWAN-HI and AD scale were strongly influenced by genetic factors (73%, 90% and 82%, respectively). However, there were striking differences in genetic architecture: variation in CBCL AP scores is in large part explained by non-additive genetic influences. Variation in SWAN scores is explained by additive genetic influences only.



Ratings on the SWAN cover the continuum from positive attention skills to attention and hyperactivity problems that define ADHD. Instruments such as the SWAN offer clinicians and researchers the opportunity to examine variation in both strengths and weaknesses in attention skills.
Mucin gene (MUC1) transfected dendritic cells as vaccine: results of a phase I/II clinical trial

Dendritic cells (DC) derived from peripheral blood monocytes are currently being investigated in clinical trials for their role in stimulating the immune system. We performed a phase I/II clinical trial using human autologous DC transfected with cDNA of the human tumor antigen mucin (MUC1) as a vaccine in 10 patients with advanced breast, pancreatic or papillary cancer. After liposomal transfection, flow cytometry testing showed that 2% to 53% of the DC expressed mucin epitopes. Patients were immunized two or three times with 1 million transfected DC injected subcutaneously (s.c.). A vaccine-specific delayed-type hypersensitivity (DTH) reaction was observed in 3 out of 10 patients. After vaccination, 4 patients showed a 2- to 10-fold increase in the frequency of mucin-specific interferon-gamma (IFN-γ)-secreting CD8+ T cells. We demonstrated the feasibility and safety of a vaccine consisting of autologous gene-transfected DC, and that immunologic responses could be induced even in patients with pretreated and advanced disease.
Upper limb progressive resistance training and stretching exercises following surgery for early breast cancer: a randomized controlled trial

The aim of this study was to determine whether an exercise program, commencing 4–6 weeks post-operatively, reduces upper limb impairments in women treated for early breast cancer. Women (n = 160) were randomized to either an 8-week exercise program (n = 81) or to a control group (n = 79) following stratification for axillary surgery. The exercise program comprised a weekly session and home program of passive stretching and progressive resistance training for shoulder muscles. The control group attended fortnightly assessments but no exercises were provided. The primary outcome was self-reported arm symptoms derived from the EORTC breast cancer-specific questionnaire (BR23), scored out of 100 with a low score indicative of fewer symptoms. The secondary outcomes included physical measures of shoulder range of motion, strength, and swelling (i.e., lymphedema). Women were assessed immediately following the intervention and at 6 months post-intervention. The change in symptoms from baseline was not significantly different between groups immediately following the intervention or at 6 m post-intervention. The between group difference immediately following the intervention was 4 (95% CI −1 to 9) and 6 months post-intervention was 4 (−2 to 10). However, the change in range of motion for flexion and abduction was significantly greater in the exercise group immediately following the intervention, as was change in shoulder abductor strength. In conclusion, a supervised exercise program provided some, albeit small, additional benefit at 6 months post-intervention to women who had been provided with written information and reminders to use their arm. Both the groups reported few impairments including swelling immediately following the intervention and 6 months post-intervention. Notably, resistance training in the post-operative period did not precipitate lymphedema.
Tropisetron (Navoban) in the prevention of chemotherapy-induced nausea and vomiting — the Nordic experience

An open,noncomparative, Nordic multicenter study was carried out during 1991–1992 to evaluate the 5-HT3 receptor antagonist tropisetron (Navoban) as an antiemetic agent for various types of cancer chemotherapy. A total of 630 patients were recruited from 15 centers in Sweden, Denmark, and Finland. Gynecological cancers (60%), breast cancer (15%), and lung cancer (10%) were the main diagnoses. Prior experience of chemotherapy was documented in 338 patients (54%). In 260 patients (41%), cisplatin was part of the cytostatic regimen. Carboplatin (23%), doxorubicin (27%), and epidoxorubicin (24%) were also frequently included. In all, 23 cytostatic agents were used in various combinations. The mean number of courses studied was 4.6 (range 1–19). Altogether, 394 of 619 evaluable patients (64%) were completely protected from acute nausea and vomiting during the first course of chemotherapy. Delayed nausea and vomiting were completely prevented in 45%–73% (days 2–6) in the complete series. Treatment efficacy remained stable (60%–79%) during ten consecutive courses of chemotherapy. With noncisplatin regimens, complete protection from acute nausea and vomiting was achieved in 72% compared with 52% for cisplatin regimens (P<0.0001). Patients without prior experience of chemotherapy had higher control rates of acute nausea and vomiting (72%) compared to patients treated before (57%) during the first course,but not later on. There were no differences in delayed nausea and vomiting. Sex and age were significant prognostic factors with regard to antiemetic response. Adverse events were recorded in 19%–37% of the cases during long-term follow-up. Headache (18%) and constipation (8%) were most frequent. The side effects were mild, however, and tropisetron (Navoban) was a safe drug and was well tolerated by the patients.
Clinical Analysis of 61 Systemic Lupus Erythematosus Patients With Intestinal Pseudo-Obstruction and/or Ureterohydronephrosis

The objective of this article is to investigate the clinical features of intestinal pseudo-obstruction (IPO) and/or ureterohydronephrosis in systemic lupus erythematosus (SLE). Sixty-one SLE patients with IPO and/or ureterohydronephrosis were analyzed retrospectively. A total of 183 cases were randomly selected as controls from 3840 SLE inpatients without IPO and ureterohydronephrosis during the same period. Patients were assigned to 1 of the 3 groups (SLE with IPO and ureterohydronephrosis, SLE with IPO, and SLE with ureterohydronephrosis). The clinical characteristics, treatments, and prognosis were compared between the 3 groups. There were 57 females and 4 males, with a mean age of 32.0 years. IPO was the initial manifestation of SLE in 49.1% of the cases, whereas ureterohydronephrosis in 32.5%. All patients were initially treated with a high-dose steroid. Thirty-one of these patients (50.8%) also received intravenous methylprednisolone pulse therapy. Two patients died of bowel perforation and lupus encephalopathy, and the other 59 patients (96.7%) achieved remission after treatment. The incidences of fever, glomerulonephritis, nervous system involvement, serositis, erythrocyte sedimentation rate elevation, hypoalbuminemia, hypocomplementemia, and anti-SSA antibody positivity were significantly higher in patients with IPO and/or ureterohydronephrosis than in the control group (without IPO and ureterohydronephrosis). Also, patients with IPO and/or ureterohydronephrosis had higher SLE Disease Activity Index scores than control patients. Compared with SLE patients with IPO, the patients with IPO and ureterohydronephrosis had a significantly higher incidence of gallbladder wall thickening, biliary tract dilatation, and serositis, whereas the patients with ureterohydronephrosis had less mucocutaneous involvement and serositis. Eight of the 47 IPO patients who initially responded well to immunotherapy relapsed; however, all responded well to retreatment with adequate immunotherapy. Of these 8 patients, 4 relapsed following poor compliance and self-discontinuation of steroid or immunosuppressant therapy. The rate of poor compliance with immunotherapy and the number of organ systems involved in patients in the recurrent IPO group were significantly higher than those in the nonrecurrent IPO group. IPO and ureterohydronephrosis are severe complications of SLE. As patients usually respond readily to early optimal steroid treatment, early diagnosis and timely initiation of glucocorticoid are important to relieve symptoms, prevent complications, and improve prognosis.
Analytical validation of the new plasma calibrated Accu-Chek Test Strips (Roche Diagnostics).

The Accu-Chek Inform glucose monitor is a point-of-care system for testing blood glucose. New test strips, calibrated to deliver glucose plasma-like values, were launched on the market in May 2005. The aim of our study was to perform analytical validation of these new strips.



We compared the new plasma strips with whole blood strips; results for the plasma strips with plasma values obtained using a clinical analyzer and with whole blood values given by the glucose electrode of a blood gas analyzer; and the influence of the type of blood (capillary or venous) on the results obtained by the glucose monitor with the plasma calibrated strips.



Plasma strips give on average 7% higher results than the previous whole blood strips. However, the results given by the plasma strips on capillary whole blood, even if well correlated, are not completely comparable with those given by an analyzer for venous plasma. Nevertheless, these plasma strips and the glucose electrode of a blood gas analyzer give comparable results.



Accu-Chek Inform plasma strips are a good method for monitoring of blood glucose values in patients with diabetes.
Validation of a Clinical Prediction Rule for Severe Acute Lower Intestinal Bleeding

Acute lower intestinal bleeding is a heterogeneous disorder and identification of high-risk patients is challenging. We previously retrospectively identified predictors of severity in patients with acute lower intestinal bleeding. The aim of this study was to prospectively validate a clinical prediction rule for severe acute lower intestinal bleeding.This was a prospective, observational cohort study of consecutive patients admitted to an academic, tertiary care or a community-based teaching hospital for management of acute lower intestinal bleeding. Data were collected on seven previously identified predictors of severe bleeding: heart rate ≥ 100/min, systolic blood pressure ≤ 115 mmHg, syncope, nontender abdominal exam, rectal bleeding in the first 4 h of evaluation, aspirin use, and >2 comorbid conditions. Severe bleeding was defined as transfusion of ≥2 units of red blood cells, and/or a decrease in hematocrit of ≥20% in the first 24 h, and/or recurrent rectal bleeding after 24 h of stability (accompanied by a further decrease in hematocrit of ≥20%, and/or additional blood transfusions, and/or readmission for acute lower intestinal bleeding within 1 wk of discharge). Patients were stratified into 3 risk groups according to the previously developed prediction rule: low (no risk factors), moderate (1–3 risk factors), and high (>3 risk factors).RESULTS:A total of 275 patients with acute lower intestinal bleeding were identified. The risk of severe bleeding in each risk category was similar in the validation and derivation cohorts (p values >0.05): low risk 6% versus 9%, moderate risk 43% versus 43%, and high risk 79% versus 84%. The area under the receiver operating characteristic curve was 0.754 for the validation cohort and 0.761 for the derivation cohort. The magnitude of the risk score was significantly correlated with major clinical outcomes including surgery, death, blood transfusions, and length of stay.We have developed and prospectively validated a clinical prediction rule for acute severe lower intestinal bleeding. This prediction rule could improve the triage of patients to appropriate levels of care and interventions, and guide a more standardized approach to acute lower intestinal bleeding.
Influence of levothyroxine in augmentation therapy for bipolar depression on central serotonergic function.

Adjunctive treatment with supraphysiological doses of levothyroxine (L-T4) in bipolar depression shows promise, but the neurobiological mechanisms underlying clinical improvement are unknown. It has been postulated from animal studies that exogenous thyroid hormones may exert their modulatory effects in patients with affective disorders via an increase in serotonergic neurotransmission. Therefore, we investigated the loudness dependence of auditory evoked potentials (LDAEP) as a measure of central serotonergic activity and response to L-T4.



This 6-week, double-blind, randomized, placebo-controlled study assessed the efficacy of L-T4 adjunctive to continuing treatment with mood stabilizer and/or antidepressant medication in 20 patients with bipolar depression. LDAEP was assessed before and after treatment with L-T4.



Scores of the Hamilton Depression Rating Scale and Montgomery Asberg Depression Rating Scale decreased significantly during the study. There was no difference in pre- and post-treatment LDAEP between the groups, and no correlation between LDAEP and psychometric measures in the course of the study.



The hypothesis of a relationship between response of augmentation therapy with levothyroxine in bipolar depression and serotonergic activity could not be confirmed.