nils-herrmann/clean_scirepeval huggingface dataset:
Comprehensive rehabilitation in chronic heart failure--better psycho-emotional status related to quality of life, brain natriuretic peptide concentrations, and clinical severity of disease.

To evaluate the effects of a comprehensive outpatient rehabilitation program in chronic heart failure (CHF) on quality of life (QoL) in relation to emotional status and clinical severity of disease.



25 patients with CHF were included in the 12-week comprehensive rehabilitation program. Initially, and at the end of the program, patients underwent graded cardio-pulmonary exercise testing, echocardiography, and determination of brain natriuretic peptide (BNP) concentration. In addition, they were assessed using: The Minnesota Living with Health Failure Questionnaire [MLHFQ]) for disease Specific QoL, the Hospital Anxiety and Depression Scale [HADS], and the State-Trait Anger Expression Inventory [STAXI]).



After 12 weeks of rehabilitation improvements in NYHA class, left ventricular ejection fraction (LVEF), and peak oxygen consumption were found, while mean BNP concentrations did not change. Disease specific QoL demonstrated improvements in physical component and the total score. Relative improvement of psycho-emotional scores correlated positively with relative improvement of disease specific QoL. In patients with LVEF > or =30% at baseline, changes in BNP concentration were positively associated with both anxiety and state anger, and with the emotional component score of MLHFQ.



Improvements in disease-specific QoL were closely associated to improvements of psycho-emotional status and clinical severity of CHF.
Use of Home Telemonitoring to Support Multidisciplinary Care of Heart Failure Patients in Finland: Randomized Controlled Trial

Heart failure (HF) patients suffer from frequent and repeated hospitalizations, causing a substantial economic burden on society. Hospitalizations can be reduced considerably by better compliance with self-care. Home telemonitoring has the potential to boost patients' compliance with self-care, although the results are still contradictory.



A randomized controlled trial was conducted in order to study whether the multidisciplinary care of heart failure patients promoted with telemonitoring leads to decreased HF-related hospitalization.



HF patients were eligible whose left ventricular ejection fraction was lower than 35%, NYHA functional class ≥2, and who needed regular follow-up. Patients in the telemonitoring group (n=47) measured their body weight, blood pressure, and pulse and answered symptom-related questions on a weekly basis, reporting their values to the heart failure nurse using a mobile phone app. The heart failure nurse followed the status of patients weekly and if necessary contacted the patient. The primary outcome was the number of HF-related hospital days. Control patients (n=47) received multidisciplinary treatment according to standard practices. Patients' clinical status, use of health care resources, adherence, and user experience from the patients' and the health care professionals' perspective were studied.



Adherence, calculated as a proportion of weekly submitted self-measurements, was close to 90%. No difference was found in the number of HF-related hospital days (incidence rate ratio [IRR]=0.812, P=.351), which was the primary outcome. The intervention group used more health care resources: they paid an increased number of visits to the nurse (IRR=1.73, P<.001), spent more time at the nurse reception (mean difference of 48.7 minutes, P<.001), and there was a greater number of telephone contacts between the nurse and intervention patients (IRR=3.82, P<.001 for nurse-induced contacts and IRR=1.63, P=.049 for patient-induced contacts). There were no statistically significant differences in patients' clinical health status or in their self-care behavior. The technology received excellent feedback from the patient and professional side with a high adherence rate throughout the study.



Home telemonitoring did not reduce the number of patients' HF-related hospital days and did not improve the patients' clinical condition. Patients in the telemonitoring group contacted the Cardiology Outpatient Clinic more frequently, and on this way increased the use of health care resources.
The relationship between subjective well-being and dopamine D2 receptors in patients treated with a dopamine partial agonist and full antagonist antipsychotics.

Antipsychotic drugs produce unpleasant subjective experiences, which have been associated with high levels of dopamine D2 receptor occupancy. Aripiprazole is a partial agonist antipsychotic, which is hypothesized to produce a different subjective experience profile compared to standard D2 antagonist antipsychotics. The aim of this study was to compare the effect of D2 occupancy produced by a partial agonist antipsychotic (aripiprazole) to that of antagonist antipsychotics (risperidone or olanzapine) on the subjective well-being of patients. Subjective well-being was measured using the Subjective Well-being under Neuroleptics Scale (SWN) and was related to dopamine D2 receptor occupancy using [11C]raclopride PET. Patients that were switched to aripiprazole showed improvement in their subjective well-being from 79.80 (S.D.=16.08) to 89.90 (S.D.=15.33), an effect that was sustained for 6 months. This sustained improvement was observed despite very high levels of DA D2 occupancy (82-99%), in contrast to the effects of antagonist antipsychotics on subjective well-being.
Recombinant human thrombopoietin (rhTPO) after autologous bone marrow transplantation: a phase I pharmacokinetic and pharmacodynamic study

Thrombocytopenia following myelotoxic therapy is a common problem and when severe (<20 000/μl) can lead to severe morbidity and mortality. Thrombopoietin (TPO) is a naturally occurring glycosylated peptide which stimulates the differentiation of bone marrow stem cells into megakaryocyte progenitor cells, induces the expression of megakaryocyte differentiation markers, promotes megakaryocyte proliferation, polyploidization and, ultimately, the formation of increased numbers of platelets in the circulation. TPO has now been produced by recombinant technology and has entered clinical trials. This open label phase I study was designed to determine the safety, tolerance and pharmacokinetics of recombinant thrombopoietin (rhTPO) when administered to patients after undergoing high-dose chemotherapy followed by autologous bone marrow transplantation. rhTPO was administered intravenously by bolus injection at doses ranging from 0.3 to 4.8 μg/kg/day every 3 days to 30 patients and 0.6 μg/kg daily to three patients. rhTPO was begun the day after marrow infusion and continued until platelet recovery to <20 000/μl. G-CSF was concomitantly administered to promote myeloid recovery. Serious adverse events or neutralizing antibodies to rhTPO were not observed during the study. Median platelet recovery after ABMT was 19 days (range, 11–41). Neither the dose nor the schedule of rhTPO appeared to have any impact upon the time course of platelet recovery. In this phase I study, rhTPO was found to be well tolerated without the development of neutralizing antibodies and without compromising neutrophil recovery. Platelet recovery was similar for all doses studied warranting further evaluation in phase II and III trials designed to test for platelet recovery efficacy. Bone Marrow Transplantation (2001) 27, 261–268.
SUVmax of 18FDG PET/CT as a predictor of high-risk endometrial cancer patients.

To evaluate SUVmax in the assessment of endometrial cancer preoperatively with particular focus on myometrial invasion (MI), cervical invasion (CI), FIGO stage, risk-stratification and lymph node metastases (LNM).



A total of 268 women with endometrial cancer or atypical endometrial hyperplasia underwent FDG PET/CT imaging before surgical treatment. SUVmax of the primary tumour was compared with histological prognostic factors.



SUVmax was significantly higher in patients with high FIGO stages (p<0.0001), deep MI (p=0.002), CI (p=0.04), LNM (p=0.04) and high risk tumours (p=0.003). Linear regression found that SUVmax was dependent of MI (p=0.001, 95% CI 2.863-11.098), CI (p=0.001, 95% CI 2.896-11.499), risk (p=0.004, 95% CI 0.077-0.397), LNM (p=0.04, 95% CI 0.011-0.482) and FIGO stage (p<0.0001, 95% CI 0.158-0.473).



Preoperative PET/CT scanning and SUVmax measurements of the primary tumour may provide additional clinical and prognostic information about MI, CI, LNM and high risk disease in patients with endometrial cancer and allow for individualization of patient care. However, the sensitivity and specificity of the SUVmax in staging endometrial cancer is not high enough to reliably replace surgical staging.
Management of Nonfunctioning Islet Cell Carcinomas

Tumors arising from the pancreatic islet cells are rare and represent a heterogeneous group of benign or malignant lesions. Most tumors present with well characterized syndromes, whereas others appear to be nonfunctioning. The clinical features of 11 men and 7 women with nonfunctioning islet cell carcinomas operated on between 1983 and 1998 were reviewed. The median patient age was 53.5 years (range 26–74 years). The most frequent presenting symptoms were abdominal pain (13 patients), weight loss (7 patients), and obstructive jaundice (4 patients). Gut hormone profiles were normal in all patients. Abdominal sonography and computed tomography localized the tumor in 17 patients, and correct prediction of an endocrine tumor was achieved in 12 patients. Six of seven patients showed a hypervascular tumor upon angiograpy, and seven of eight patients preoperatively had positive somatostatin receptor scintigraphy. At operation, regional or distant metastases were present in 15 (83%) and 6 (33%) patients, respectively. Eleven patients underwent potentially curative resections, and the remaining seven patients were managed palliatively by resection (four patients) or bypass procedures (three patients). Three patients had up to three more resection for metastases. Eight patients received postoperative octreotide, interferon α therapy, or both. The overall cumulative 5- and 10-year survival rates were 65.4% and 49.1%, respectively. Of the 11 patients who underwent curative resection, 10 were alive after a median follow-up of 63 months (range 7–180 months), but only 5 are free from disease. Although surgical cure is rare in nonfunctioning islet cell carcinomas, significant long-term palliation can be achieved in a large proportion of patients with an aggressive surgical approach and, when indicated, additional medical therapy.
Safety and efficacy of neoadjuvant FOLFIRINOX treatment in a series of patients with borderline resectable pancreatic ductal adenocarcinoma.

adamantinoma). Case report and review of literature .  Qureshi AA , Shott S , Mallin BA , Gitelis S . Current trends in the [2] management of adamantinoma of long bones. An international study .  Hazelbag HM , Taminiau AH , Fleuren GJ , Hogendoorn PC .  Adamantinoma of the long bones. A clinicopathological study of thirty-two patients with emphasis on histological subtype, precursor lesion, and biological behavior .  Metastatic adamantinoma of bone to lung. A case [4] report of the natural history and the use of chemotherapy and radiation therapy .  Metastatic adamantinoma responds to treatment with receptor tyrosine kinase inhibitor . Acta Oncol 2010 ; 49 : 101 – 4 . Van Der Graaf WT , Blay JY , Chawla SP , Kim DW , Bui-Nguyen [6] B , Casali PG , et al . Pazopanib for metastatic soft-tissue sarcoma (PALETTE): A randomised, double-blind, placebocontrolled phase 3 trial . Lancet 2012 ; 379 : 1879 – 86 . Motzer R , Hutson TE , Reeves J , Hawkins R , Guo J , Nathan [7] P , et al . Randomized, open-label, phase III trial of pazopanib versus sunitinib in fi rst-line treatment of patients with metastatic renal cell carcinoma (MRCC): Results of the COMPARZ trial. 37th ESMO Congress ; 2012 Sep 28 – Oct 2 ; Vienna, Austria . ing to manufacturer instructions). The cancer panel also included SMARCB1, a gene that when mutated is associated with hypersensitivity to pazopanib in cell cultures (see the ‘ Genomics of Drug Sensitivity in Cancer ’ database; (http://www.cancerrxgene.org/translation/Drug/199); this, however, was also found to be un-mutated. We suggest that treatment with pazopanib should be considered in the setting of metastatic AD. Further molecular profi ling of AD may identify the specifi c pathway and shed light on the mechanisms involved in sensitivity to pazopanib.
Preparation and evaluation of the rhenium-188-labelled anti-NCA antigen monoclonal antibody BW 250/183 for radioimmunotherapy of leukaemia

Anti-NCA antigen antibody BW 250/183 (Anti-Granulocyte) localizes more than 50% of injected antibody dose to the bone marrow. Therefore, this antibody is promising for adjuvant conditioning radioimmunotherapy of bone marrow before bone marrow transplantation. To examine its potential use for radioimmunotherapy, we developed an efficient and reproducible technical protocol for labelling anti-NCA antigen antibody BW 250/183 with generator-produced rhenium-188, aiming at both high radiochemical yield and high specific activity. 188Re-labelled BW 250/183 antibody was used in 12 patients with advanced leukaemia. Labelling of BW 250/183 with 188Re was accomplished by the direct radiolabelling method using tris-(2-carboxyethyl) phosphine (TCEP) as the reducing agent. Twelve patients with recurrent acute or chronic leukaemia were treated with activities of 6.5–12.4 GBq of 188Re-labelled BW 250/183. Standard gamma camera scintigraphy was used to evaluate the biodistribution, and a region of interest analysis together with the MIRDOSE 3.1 software was applied to determine the radiation doses to relevant tissues. The 188Re-BW 250/183 antibody was labelled in high radiochemical yield, with high radiochemical purity (94%±3%) and specific activity (5.55–7.4 GBq/mg) within 1 h. The preliminary biodistribution studies showed persistent uptake of 188Re-BW 250/183 in bone marrow. The radiation absorbed doses (mGy/MBq) delivered to the total body, red marrow, liver, spleen and kidneys were 0.13±0.02, 1.45±0.71, 0.43±0.21, 1.32±0.99 and 0.71±0.17, respectively. TCEP reduction enabled the direct, fast and effective labelling of the monoclonal antibody BW 250/183 with 188Re. Preliminary clinical results suggest delivery of a significant radiation dose to bone marrow and thus the potential for adjuvant conditioning therapy before BMT.
Treatment of distal ulcerative colitis (proctosigmoiditis) in relapse: comparison of hydrocortisone enemas and rectal hydrocortisone foam.

Thirty patients with distal colitis (proctosigmoiditis) in relapse were randonly allocated to twice daily treatment with traditional aqueous hydrocotrisone enemas (Cortenemas) or a suspension of hydrocortisone in an inert foam base (Colifoam). Each treatment contained the same amount of hydrocortisone. Clinical, sigmoidoscopic, and histological response was assessed after two weeks. Both agents were effective, and broadly similar in terms of objective improvement, but subjective improvement was greater with the foam preparation, and several patients expressed a preference to this mode of treatment.
Pharmacokinetics of sulfobutylether-beta-cyclodextrin and voriconazole in patients with end-stage renal failure during treatment with two hemodialysis systems and hemodiafiltration.

Sulfobutylether-beta-cyclodextrin (SBECD), a large cyclic oligosaccharide that is used to solubilize voriconazole (VRC) for intravenous administration, is eliminated mainly by renal excretion. The pharmacokinetics of SBECD and voriconazole in patients undergoing extracorporeal renal replacement therapies are not well defined. We performed a three-period randomized crossover study of 15 patients with end-stage renal failure during 6-hour treatment with Genius dialysis, standard hemodialysis, or hemodiafiltration using a high-flux polysulfone membrane. At the start of renal replacement therapy, the patients received a single 2-h infusion of voriconazole (4 mg per kg of body weight) solubilized with SBECD. SBECD, voriconazole, and voriconazole-N-oxide concentrations were quantified in plasma and dialysate samples by high-performance liquid chromatography (HPLC) and by HPLC coupled to tandem mass spectrometry (LC-MS-MS) and analyzed by noncompartmental methods. Nonparametric repeated-measures analysis of variance (ANOVA) was used to analyze differences between treatment phases. SBECD and voriconazole recoveries in dialysate samples were 67% and 10% of the administered doses. SBECD concentrations declined with a half-life ranging from 2.6 +/- 0.6 h (Genius dialysis) to 2.4 +/- 0.9 h (hemodialysis) and 2.0 +/- 0.6 h (hemodiafiltration) (P < 0.01 for Genius dialysis versus hemodiafiltration). Prediction of steady-state conditions indicated that even with daily hemodialysis, SBECD will still exceed SBECD exposure of patients with normal renal function by a factor of 6.2. SBECD was effectively eliminated during 6 h of renal replacement therapy by all methods, using high-flux polysulfone membranes, whereas elimination of voriconazole was quantitatively insignificant. The SBECD half-life during renal replacement therapy was nearly normalized, but the average SBECD exposure during repeated administration is expected to be still increased.
Safety and efficacy of spinal vs general anaesthesia in bone marrow harvesting

Bone marrow harvesting (BMH) can be performed with either general (GA) or spinal anaesthesia (SPA). Whether SPA is advantageous in BMH and if this technique is safe for procedures performed in the prone position is still controversial. To evaluate the safety and efficacy of both anaesthetic techniques in BMH, 37 allogeneic donors (nine female, 28 male; 34.3 ± 9 years; ASA class 1–2) received either spinal (group 1, n = 20) or general anaesthesia (group 2, n = 17) according to their personal wishes. Under standardised harvesting conditions, haematology parameters, cell counts (MNC, CD34+), haemodynamic parameters, adverse reactions and patient satisfaction were registered. No differences were seen between groups with respect to demographic data, harvesting time (55 ± 17 vs 60 ± 16 min) and bone marrow cell counts (MNC: 6.68 ± 2.1 vs 5.7 ± 1.7 ml/106). The incidence of hypotension was higher in group 1 (45 vs 10.8%; P = 0.042). Postoperative analgesic requirement and emesis were increased in group 2 (P < 0.04) in comparison to group 1. in conclusion, the present study failed to show superiority of spinal over general anaesthesia with regard to the quality of the harvested bone marrow. however, the lower incidence of complaints after spinal anaesthesia appears to offer an advantage over ga in healthy allogeneic bone marrow donors.
CD34+ stem cell augmentation of elutriated allogeneic bone marrow grafts: results of a phase II clinical trial of engraftment and graft-versus-host disease prophylaxis in high-risk hematologic malignancies

Although T cell depletion of allografts used in BMT has reduced GVHD, it has been associated with inferior engraftment and an increased risk of relapse. We have found that T cell depletion by counterflow centrifugal elutriation (CCE) also results in depletion of CD34+ stem cells. In order to determine if the discarded CD34+ cells would improve engraftment, we undertook a phase II trial of allogeneic BMT in which 110 patients (median age 43) with a variety of hematologic malignancies received CD34+ stem cell augmented, elutriated marrow grafts. The T cell-depleted grafts were tightly controlled and contained a mean of 4.3 × 107 mononuclear cells/kg, 3.3 × 106 CD34+ cells/kg, 1.5 × 105 CFU-GM/kg and 5.5 × 105 CD3+ T cells/kg. Median time to engraftment of granulocytes (>500/μl) was 16 days and of platelets (>50 000/μl) was 25 days, comparable to that seen with unmanipulated marrow. No mixed hematopoietic chimerism was observed that was not associated with disease relapse. The four patients (3.6%) who failed to engraft were all at high risk because of prior donor transfusions or underlying marrow disorders. The incidence of GVHD was dependent on the duration of cyclosporin A (CsA) immunosuppression. In patients who received CsA for ⩾80 days, the incidence of clinically significant acute GVHD (>stage 1) and extensive, chronic GVHD was 5% and 11%, respectively. Peri-transplant (⩽100 day post-BMT) mortality for this group of patients was 15%. Event-free survival in selected subsets of patients compared favorably to previous studies in which patients received unmanipulated marrow allografts.
Cervicovestibular rehabilitation in sport-related concussion: a randomised controlled trial.

Concussion is a common injury in sport. Most individuals recover in 7-10 days but some have persistent symptoms. The objective of this study was to determine if a combination of vestibular rehabilitation and cervical spine physiotherapy decreased the time until medical clearance in individuals with prolonged postconcussion symptoms.



This study was a randomised controlled trial. Consecutive patients with persistent symptoms of dizziness, neck pain and/or headaches following a sport-related concussion (12-30 years, 18 male and 13 female) were randomised to the control or intervention group. Both groups received weekly sessions with a physiotherapist for 8 weeks or until the time of medical clearance. Both groups received postural education, range of motion exercises and cognitive and physical rest until asymptomatic followed by a protocol of graded exertion. The intervention group also received cervical spine and vestibular rehabilitation. The primary outcome of interest was medical clearance to return to sport, which was evaluated by a study sport medicine physician who was blinded to the treatment group.



In the treatment group, 73% (11/15) of the participants were medically cleared within 8 weeks of initiation of treatment, compared with 7% (1/14) in the control group. Using an intention to treat analysis, individuals in the treatment group were 3.91 (95% CI 1.34 to 11.34) times more likely to be medically cleared by 8 weeks.



A combination of cervical and vestibular physiotherapy decreased time to medical clearance to return to sport in youth and young adults with persistent symptoms of dizziness, neck pain and/or headaches following a sport-related concussion.
Atrial fibrillation detection and R-wave synchronization by Metrix implantable atrial defibrillator: implications for long-term efficacy and safety. The Metrix Investigators.

The long-term efficacy of atrial fibrillation (AF) detection and R-wave synchronization are critical safety requirements for the development of an implantable atrial defibrillator (IAD) for treatment of AF.



The long-term efficacy of the Metrix IAD for AF detection and R-wave synchronization was tested in 51 patients. The mean duration of follow-up was 259+/-138 days (72 to 613 days). AF detection tests were performed 2240 times during observed operation with 100% specificity and 92.3% sensitivity for differentiation between sinus rhythm and AF; 2219 episodes and their electrograms stored in the device during AF detection were analyzed. The positive predictive value of the AF detection algorithm was 97.4% (lower 95% confidence limit [CL], 94.5%) in the out-of-hospital setting. A total of 242 435 R waves were analyzed for R-wave synchronization. Of these, 49% were marked for synchronized shock delivery, 82% of sinus rhythm and 36% of AF R waves, respectively. All shock markers were properly synchronized and within the R wave (overall synchronization accuracy, 100%; lower 95% CL, 99.999%). Overall, 3719 shocks have been delivered via the IAD with no instance of unsynchronized shock delivery or any episode of proarrhythmia. The observed proarrhythmic risk was 0%, with an estimated maximum proarrhythmic risk of 0.084% per shock (95% upper CL).



The Metrix IAD can appropriately detect AF with a high specificity and sensitivity and reliably synchronize within a suitable R wave for shock delivery to minimize the risk of ventricular proarrhythmia.