nils-herrmann/clean_scirepeval huggingface dataset:
Study protocol for a randomised controlled trial of internet-based cognitive-behavioural therapy for obsessive-compulsive disorder

Obsessive-Compulsive Disorder (OCD) is a common chronic psychiatric disorder that constitutes a leading cause of disability. Although Cognitive-Behaviour Therapy (CBT) has been shown to be an effective treatment for OCD, this specialised treatment is unavailable to many due to access issues and the social stigma associated with seeing a mental health specialist. Internet-based psychological treatments have shown to provide effective, accessible and affordable treatment for a range of anxiety disorders, and two Randomised Controlled Trials (RCTs) have demonstrated the efficacy and acceptability of internet-based CBT (iCBT) for OCD, as compared to waitlist or supportive therapy. Although these initial findings are promising, they do not isolate the specific effect of iCBT. This paper details the study protocol for the first randomised control trial evaluating the efficacy of therapist-assisted iCBT for OCD, as compared to a matched control intervention; internet-based therapist-assisted progressive relaxation training (iPRT). It will aim to examine whether therapist-assisted iCBT is an acceptable and efficacious treatment, and to examine how effectiveness is influenced by patient characteristics.



A randomised controlled trial using repeated measures with two arms (intervention and matched control) will be used to evaluate the efficacy and acceptability of iCBT for OCD. The RCT will randomise 212 Australian adults with a primary diagnosis of OCD into either the active intervention or control condition, for 12 weeks duration. Outcomes for participants in both study arms will be assessed at baseline and post-intervention. Participants in iCBT will be further assessed at six month follow-up, while participants in the control condition will be crossed over to receive the iCBT intervention and reassessed at post-intervention and six month follow-up. The primary outcome will be clinically significant change in obsessive-compulsive symptom scores.



This will be the first known therapist assisted internet-based trial of a comprehensive CBT treatment for OCD as compared to a matched control intervention. Demonstrating the efficacy of an internet-based treatment for OCD will allow the development of models of care for broad-based access to an evidence-based but complex treatment.
The impact of the pathological lymph node status on adjuvant systemic treatment recommendations in clinically node negative breast cancer patients

Several independent randomized controlled trials are initiated to investigate whether sentinel lymph node biopsy can be safely omitted in clinically node negative breast cancer patients with negative axillary ultrasound findings, who are treated with breast conserving therapy. A consequence of omitting sentinel lymph node biopsy is absence of pathological lymph node status information. We aimed to investigate the impact of omitting sentinel lymph node biopsy on adjuvant systemic treatment recommendations. Data from all consecutive patients with invasive breast cancer and negative axillary ultrasound findings treated with breast conserving therapy and sentinel lymph node biopsy between 2008 and 2012 were collected from a prospective database. Two methods, Adjuvant! Online and the Dutch breast cancer guideline 2012, were used to determine the adjuvant systemic treatment recommendations of every patient. At first, each patient was considered to be lymph node negative, and secondly the patients’ true pathological lymph node status was used. A total of 303 patients were consecutively included. Pathological lymph node status was pN0 in 72.3 %, pN0(i+) in 12.9 %, pN1mi+ in 5.6 %, pN1 in 7.3 %, and pN2 in 2.0 % of the patients. The decision to recommend adjuvant systemic treatment changed due to the pathological lymph node status in 1.0 % of the patients (3/303) when using Adjuvant! Online and in 3.6 % (11/303) when using the 2012 Dutch breast cancer guideline. The impact of the pathological lymph node status on adjuvant systemic treatment recommendations in clinically node negative breast cancer patients with negative axillary ultrasound findings treated with breast conserving therapy is limited. The safety of omitting the sentinel lymph node biopsy should be confirmed by the initiated randomized controlled trials.
The relationship between the site of metastases and outcome in children with stage IV Wilms Tumor: data from 3 European Pediatric Cancer Institutions.

The aim of this study was to analyze in detail the site of metastasis of stage 4 Wilms tumor (WT) and its correlation with outcome. The databases from 3 major European pediatric cancer institutions were screened for children with WT between 1994 and 2011. Of 208 children identified, 31 (14.9%) had metastases at diagnosis. The lung was affected in 29 children (93.5%) and the liver in 6 children (19.4%). Twenty-seven children (87.1%) had metastases isolated to 1 organ, with the lung being the most common site (80.7%). Five-year overall survival was significantly better in those children with distant disease in either lung or liver (95.8%) compared with those affected in both lung and liver (57.1%, P=0.028). Further, prognostic markers were the response of metastases to preoperative chemotherapy (P=0.0138), high-risk histology (P=0.024), and local stage (P=0.026). Five-year overall survival was 82.1% and 5-year event-free survival was 67.9%. The overall follow-up time was 74.1 and 87.2 (2 to 151) months among survivors, and the treatment-related complication rate was 16.7%. In conclusion, in our series of stage 4 WT, prognosis was excellent if histology was favorable, metastatic disease was isolated to either lungs or liver, and if metastases responded to preoperative chemotherapy.
A simple model that suggests possible cost savings when modified-release prednisone 5 mg/day is added to current treatment in patients with active rheumatoid arthritis.

The effects of a 12-week treatment with modified-release prednisone (MR-pred) on the costs of drug treatment of RA were modelled.



With the results of a recent randomized trial as source data, we expressed the effect of treatment (MR-pred vs placebo) on the decrease in the proportion of RA patients meeting disease activity thresholds for reimbursement of biologic treatment.



The results showed 11-13% more patients on MR-pred than on placebo dropped below reimbursement thresholds for The Netherlands, Belgium and the UK. Assuming 1 year of biologics cost €15,000 and MR-pred costs €1/day, €396 are saved in each patient delaying biologic treatment by 12 weeks.



Despite a considerably higher cost than conventional prednisone, MR-pred is a cost-effective option for RA patients not on glucocorticoids who are eligible for therapy with biologic agents.
Behavioral management of the triggers of recurrent headache: a randomized controlled trial.

This study was designed to evaluate the traditional advice to headache sufferers to avoid all triggers ('Avoidance'), and a novel approach to trigger management (Learning to Cope with Triggers - 'LCT') that included graduated exposure to selected triggers to promote desensitization. Individuals (84F, 43M) with migraine and/or tension-type headache were assigned randomly to one of four groups: Waiting-list (Waitlist); Avoidance; Avoidance combined with cognitive behavior therapy (Avoid + CBT); and LCT. Changes in headaches and medication consumption (in parentheses) from pre- to post-treatment were (a minus sign indicates improvement): Waitlist, +11.0% (+15.4%); Avoidance, -13.2% (-9.0%); Avoid + CBT, -30.0% (-19.4%); and LCT, -35.9% (-27.9%). Avoidance did not differ significantly from Waitlist on headaches or medication use, but LCT differed significantly from Waitlist on both measures. Avoid + CBT significantly differed from Waitlist on headaches but not medication consumption. In summary, the study failed to find support for the standard approach to trigger management of advising avoidance, but LCT emerged as a promising strategy. LCT resulted in greater improvement than the other three conditions on all measures of headaches and medication consumption, and was the only treatment condition that significantly differed from the waiting-list control condition in terms of treatment responder rate (50% or greater reduction in headaches) and medication consumption.
An intervention program with the aim to improve and maintain work productivity for workers with rheumatoid arthritis: design of a randomized controlled trial and cost-effectiveness study

Workers with rheumatoid arthritis (RA) often experience restrictions in functioning at work and participation in employment. Strategies to maintain work productivity exist, but these interventions do not involve the actual workplace. Therefore the aim of this study is to investigate the (cost)effectiveness of an intervention program at the workplace on work productivity for workers with RA.



This study is a randomized controlled trial (RCT) in specialized rheumatology treatment centers in or near Amsterdam, the Netherlands. Randomisation to either the control or the intervention group is performed at patient level. Both groups will receive care as usual by the rheumatologist, and patients in the intervention group will also take part in the intervention program. The intervention program consists of two components; integrated care, including a participatory workplace intervention. Integrated care involves a clinical occupational physician, who will act as care manager, to coordinate the care. The care manager has an intermediate role between clinical and occupational care. The participatory workplace intervention will be guided by an occupational therapist, and involves problem solving by the patient and the patients' supervisor. The aim of the workplace intervention is to achieve consensus between patient and supervisor concerning feasible solutions for the obstacles for functioning at work. Data collection will take place at baseline and after 6 and 12 months by means of a questionnaire. The primary outcome measure is work productivity, measured by hours lost from work due to presenteeism. Secondary outcome measures include sick leave, quality of life, pain and fatigue. Cost-effectiveness of the intervention program will be evaluated from the societal perspective.



Usual care of primary and outpatient health services is not aimed at improving work productivity. Therefore it is desirable to develop interventions aimed at improving functioning at work. If the intervention program will be (cost)effective, substantial improvements in work productivity might be obtained among workers with RA at lower costs. Results are expected in 2015.
Incremental diagnostic value of preoperative 99mTc-MIBI SPECT in patients with a parathyroid adenoma.

The purpose of this prospective study was to evaluate the diagnostic value of early parathyroid SPECT combined with quantitative analysis as compared with planar imaging in patients undergoing minimally invasive radioguided surgery.



A total of 52 consecutive patients with primary hyperparathyroidism underwent planar and SPECT parathyroid scintigraphy 2-5 d before surgery. Each patient had a single-tracer dual-phase technique using (99m)Tc-methoxyisobutylisonitrile ((99m)Tc-MIBI) and a double-tracer subtraction technique using a delayed (99m)Tc-pertechnetate scan. Immediately after the first (99m)Tc-MIBI planar image, a SPECT study was acquired. Before radioguided parathyroidectomy, each patient was reinjected with (99m)Tc-MIBI. Serum calcium levels were available for all patents before surgery and at 8 and 24 h after surgery. Serum parathyroid hormone (PTH) levels were also available for all patients. Quantitative analysis was performed using the average count ratio of parathyroid to left thyroid lobe, right thyroid lobe, and maximum thyroid activity. All patients had histopathologic examination of the removed glands.



The average time for radioguided surgery was 30 min (range, 20-40 min). Postsurgical calcium levels correlated significantly with the adenoma weight (r = 0.5; P = 0.016). Combined planar scintigraphy correctly identified 41 adenomas (79%). SPECT increased the sensitivity to 96%. SPECT was superior to planar imaging in 9 patients, mainly in patients with ectopic adenomas or with multinodular goiters. Gland size did not affect significantly the detectability of SPECT. 
Our data indicate that early preoperative SPECT in patients with primary hyperparathyroidism is essential for accurate localization of parathyroid adenomas and for the selection of patients who are candidates for minimally invasive radioguided surgery. Planar parathyroid imaging is less sensitive compared with SPECT, and washout kinetics of (99m)Tc-MIBI are unreliable in the dual-phase technique. Patients with higher presurgical PTH levels may especially benefit from radioguided surgery.
A multicenter prospective cohort study of the Strata valve for the management of hydrocephalus in pediatric patients

Object. Previous reports suggest that adjustable valves may improve the survival of cerebrospinal fluid shunts or relieve shunt-related symptoms. To evaluate these claims, the authors conducted a prospective multicenter cohort study of children who underwent placement of Strata valves.  Patients undergoing initial shunt placement (Group 1) or shunt revision (Group 2) were treated using Strata valve shunt systems. Valves were adjustable to five performance level settings by using an externally applied magnet. The performance levels were checked using an externally applied hand tool and radiography. Patients were followed for 1 year or until they underwent shunt revision surgery. Between March 2000 and February 2002, 315 patients were enrolled in the study. In Group 1 (201 patients) the common causes of hydrocephalus were myelomeningocele (16%), aqueductal stenosis (14%), and hemorrhage (14%). The overall 1-year shunt survival was 67%. Causes of shunt failure were obstruction (17%), overdrainage (1.5%), loc­ ulated ventricles (2%), and infection (10.6%)Patients in Group 2 (114 patients) were older and the causes of hydro­ cephalus were similar. Among patients in Group 2 the 1-year shunt survival was 71%. There were 256 valve adjustments. Symptoms completely resolved (26%) or improved (37%) after 63% of adjust­ ments. When symptoms improved or resolved, they did so within 24 hours in 89% of adjustments. Hand-tool and ra­ diographic readings of valve settings were the same in 234 (98%) of 238 assessments.  The 1-year shunt survival for the Strata valve shunt system when used in initial shunt insertion pro­ cedures or shunt revisions was similar to those demonstrated for other valves. Symptom relief or improvement fol­ lowing adjustment was observed in 63% of patients. Hand-tool assessment of performance level settings reliably predicted radiographic assessments.
Combination of copeptin and troponin assays to rapidly rule out non-ST elevation myocardial infarction in the emergency department.

The aim of this study was to analyze the diagnostic accuracy and the clinical usefulness of the combination of troponin I (cTnI) and copeptin measured at presentation with an automated assay to rapidly rule out non-ST elevation myocardial infarction (NSTEMI) in patients with suspected cardiac chest pain presenting to an emergency department (ED).



This study was an ancillary analysis of a prospective observational study. Copeptin and cTnI levels were sampled at presentation in 641 consecutive patients admitted to the ED for chest pain with onset within the last 12 hours and without ST elevation on a 12-lead electrocardiogram (ECG). Copeptin was measured with an automated assay and troponin with conventional assay. The performance of a combination of cTnI and copeptin for NSTEMI diagnosis was studied, the clinical utility was assessed by multivariate analysis, and an area under the curve (AUC) calculation was used to determine accuracy.



NSTEMI was diagnosed in 95 patients (15%). The sensitivity and negative predictive value (NPV) of the combination of copeptin and cTnI measures were 90.4% (95% confidence interval [CI] = 88.2% to 92.7%) and 97.6% (95% CI = 96.4% to 98.7%) versus 55.3% (95% CI = 51.5% to 59.2%) and 92.8% (95% CI = 90.8% to 94.8%) with cTnI alone. The AUC of the combination of copeptin and cTnI was 0.89 (95% CI = 0.85% to 0.92%) and was significantly higher than the AUC of cTnI alone (0.77, 95% CI = 0.72% to 0.82%, p < 0.05). The patient classification was slightly improved when copeptin was added to the usual diagnostic tools used for NSTEMI management.



In this study, determination of copeptin, in addition to cTnI, improves early diagnostic accuracy of NSTEMI. However, the sensitivity of this combination even using a conventional troponin assay remains insufficient to safely rule out NSTEMI at the time of presentation.
Donor, recipient, and transplant characteristics as risk factors after unrelated donor PBSC transplantation: beneficial effects of higher CD34+ cell dose.

We report outcomes of 932 recipients of unrelated donor peripheral blood stem cell hematopoietic cell transplantation (URD-PBSC HCT) for acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, and myelodysplastic syndrome enrolled on a prospective National Marrow Donor Program trial from 1999 through 2003. Preparative regimens included myeloablative (MA; N = 611), reduced-intensity (RI; N = 160), and nonmyeloablative (NMA; N = 161). For MA recipients, CD34(+) counts greater than 3.8 x 10(6)/kg improved neutrophil and platelet engraftment, whereas improved overall survival (OS) and reduced transplant-related mortality (TRM) were seen for all preparative regimens when CD34(+) cell doses exceeded 4.5 x 10(6)/kg. Higher infused doses of CD34(+) cell dose did not result in increased rates of either acute or chronic graft-versus-host disease (GVHD). Three-year OS and disease-free survival (DFS) of recipients of MA, RI, and NMA approaches were similar (33%, 35%, and 32% OS; 33%, 30%, and 29% DFS, respectively). In summary, recipients of URD-PBSC HCT receiving preparative regimens differing in intensity experienced similar survival. Higher CD34(+) cell doses resulted in more rapid engraftment, less TRM, and better 3-year OS (39% versus 25%, MA, P = .004; 38% versus 21% RI/NMA, P = .004) but did not increase the risk of GVHD.
Lack of Phenotypic Differences by Cardiovascular Magnetic Resonance Imaging in MYH7 (β-Myosin Heavy Chain)- Versus MYBPC3 (Myosin-Binding Protein C)-Related Hypertrophic Cardiomyopathy.

The 2 most commonly affected genes in hypertrophic cardiomyopathy (HCM) are MYH7 (β-myosin heavy chain) and MYBPC3 (β-myosin-binding protein C). Phenotypic differences between patients with mutations in these 2 genes have been inconsistent. Scarce data exist on the genotype-phenotype association as assessed by tomographic imaging using cardiac magnetic resonance imaging.



Cardiac magnetic resonance imaging was performed on 358 consecutive genotyped hypertrophic cardiomyopathy probands at 5 tertiary hypertrophic cardiomyopathy centers. Genetic testing revealed a pathogenic mutation in 159 patients (44.4%). The most common genes identified were MYH7 (n=53) and MYBPC3 (n=75); 33.1% and 47% of genopositive patients, respectively. Phenotypic characteristics by cardiac magnetic resonance imaging of these 2 groups were similar, including left ventricular volumes, mass, maximal wall thickness, morphology, left atrial volume, and mitral valve leaflet lengths (all P=non-significant). The presence of late gadolinium enhancement (65% versus 64%; P=0.99) and the proportion of total left ventricular mass (%late gadolinium enhancement; 10.4±13.2% versus 8.5±8.5%; P=0.44) were also similar.



This multicenter multinational study shows lack of phenotypic differences between MYH7- and MYBPC3-associated hypertrophic cardiomyopathy when assessed by cardiac magnetic resonance imaging. Postmutational mechanisms appear more relevant to thick-filament disease expression and outcome than the disease-causing variant per se.
Surgical techniques, open versus minimally invasive gastrectomy after chemotherapy (STOMACH trial): study protocol for a randomized controlled trial

Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less perioperative blood loss and faster patient recovery. It also maintains similar results with regard to tumor resection margins and oncological long-term survival. In gastric cancer the role of laparoscopic surgery remains unclear. Current recommended treatment for gastric cancer consists of radical resection of the stomach, with a free margin of 5 to 6 cm from the tumor, combined with a lymphadenectomy. The extent of the lymphadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, it is imperative that a novel surgical technique, such as minimally invasive total gastrectomy, should be non-inferior with regard to radicality of surgery and lymph node yield.



The Surgical Techniques, Open versus Minimally invasive gastrectomy After CHemotherapy (STOMACH) study is a randomized, clinical multicenter trial. All adult patients with primary carcinoma of the stomach, in which the tumor is considered surgically resectable (T1-3, N0-1, M0) after neo-adjuvant chemotherapy, are eligible for inclusion and randomization. The primary endpoint is quality of oncological resection, measured by radicality of surgery and number of retrieved lymph nodes. The pathologist is blinded towards patient allocation. Secondary outcomes include patient-reported outcomes measures (PROMs) regarding quality of life, postoperative complications and cost-effectiveness. Based on a non-inferiority model for lymph node yield, with an average lymph node yield of 20, a non-inferiority margin of -4 and a 90% power to detect non-inferiority, a total of 168 patients are to be included.



The STOMACH trial is a prospective, multicenter, parallel randomized study to define the optimal surgical strategy in patients with proximal or central gastric cancer after neo-adjuvant therapy: the conventional 'open' approach or minimally invasive total gastrectomy.
Reinstatement of the Loyalty Islands Sandalwood, Santalum
austrocaledonicum
var.
glabrum (Santalaceae), in New Caledonia

Sandalwoods encompass 19 species restricted to southeast Asia and the Pacific. The species Santalum austrocaledonicum Vieill. (Santalaceae) is endemic to New Caledonia (Grande-Terre, Isle of Pines, Loyalty Islands) and Vanuatu, where several varieties are recognized. The Loyalty Islands sandalwood variety is here reinstated as Santalum austrocaledonicum var. glabrum Hürl. emend. Butaud & P.Firmenich, mut. char. It was previously considered a synonym of the type variety; however, new morphological and genetic studies confirmed its distinctiveness. The key for New Caledonian varieties of Santalum austrocaledonicum has been updated and a short description of its essential oil composition and organoleptic quality is given.