nils-herrmann/clean_scirepeval huggingface dataset:
Whole breast irradiation for small-sized breasts after conserving surgery: is the field-in-field technique optimal?

To determine the optimal whole breast irradiation technique in patients with small-sized breasts, tangential and field-in-field IMRT (FIF) techniques were compared.



Sixteen patients with ≤3 cm breast height and ≤350 cc volume were included. Seven patients had 4D CTs performed. The planning target volumes (PTV), editing 5 and 2 mm from the surface on the whole breast, were delineated and called PTV(5) and PTV(2), respectively. Dose-volume histograms of tangential techniques with open beam (OT) and wedge filter (WT), conventional FIF (cFIF), and modified FIF (mFIF) blocking out the lung were produced. Various dose-volume parameters, the dose heterogeneity index (DHtrI), dose homogeneity index (DHmI), and PTV dose improvement (PDI) were calculated.



OT compared with WT showed a significantly favorable V 90 of the heart and lung, and PTV(5)-dose distribution. Comparing OT and cFIF, OT showed significant improvement in the V 95 of PTV(2), whereas cFIF showed significant improvement in the V 95, DHtrI, DHmI, and PDI of the PTV(5). In comparing cFIF and mFIF, mFIF showed improved dose distributions of the heart and lung, while cFIF presented the better V 95, DHtrI, DHmI, and PDI of the PTV(5). Respiratory influences on the absolute dose were mostly within 1 %. The ratio of free breathing and each respiratory phase was similar among OT, cFIF, and mFIF.



cFIF has favorable dose conformity and is suggested to be an optimal method for small-sized breasts. However, OT for dose coverage close to the skin and mFIF for normal tissue may also be potential alternatives. Respiratory effects are minimal.
Oral paricalcitol versus oral calcitriol in continuous ambulatory peritoneal dialysis patients with secondary hyperparathyroidism

Secondary hyperparathyroidism (SHPT) is common in end-stage renal disease. Our primary objective was to evaluate the efficacy of oral paricalcitol versus oral calcitriol on serum intact parathyroid hormone (iPTH) and mineral bone parameters in continuous ambulatory peritoneal dialysis (CAPD) patients with SHPT. The secondary objective was to analyze highly sensitive C-reactive protein (hsCRP) and peritoneal membrane function in both groups. This was a prospective randomized control trial. CAPD patients with SHPT were randomized to paricalcitol or calcitriol for 15 weeks. Serum intact iPTH, calcium, phosphate and alkaline phosphatase (ALP) were measured at baseline and every 3 weeks. Serum hsCRP and peritoneal membrane functions were measured at baseline and at week 15. A total of 26 patients were enrolled and randomized—12 to paricalcitol and 14 to calcitriol. Serum iPTH reduced significantly in both groups and there was no difference in the incidence of ≥50 % reduction of iPTH between both groups. There was a significant increase in serum calcium in both groups but there were no differences in serum phosphorus across the visits. The incidence of hypercalcemia was the same in both groups. Serum calcium–phosphorus (Ca × P) product increased in the paricalcitol group but decreased in the calcitriol group. Serum ALP decreased significantly in both groups. There were also no differences in pre- and post-treatment serum hsCRP and peritoneal function test (PFT) in both groups. Both oral paricalcitol and calcitriol were equally efficacious in reducing serum iPTH but were associated with significantly higher serum calcium. Serum Ca × P product increased in the paricalcitol group and decreased in the calcitriol group. Serum hsCRP level and PFT were not affected by either treatment. A larger randomized controlled trial is indicated to confirm these initial findings.
Use of screening phase data to evaluate observer variation of sputum cytodiagnosis as an outcome measure in a chemoprevention trial.

Sputum samples obtained during the screening phase of a chemoprevention trial in heavy smokers were evaluated independently by trained cytotechnologists and classified for degree of cellular atypia according to the method of Saccommano et al. (G. Saccommano et al., Cancer (Phila.), 33: 256-270, 1974). The level of agreement within and between Observers A and B was calculated as the percentage of agreement and, in addition, a statistic was used (kappa) to correct for chance-expected agreement. Between observer agreement on 300 specimens from 130 subjects was 68% (204 of 300) (kappa = 0.58). Of the 96 disagreements, only 17 were of more than one category in the six-category classification. Within observer agreement for both Observers A and B was evaluated on a subset of 60 specimens from 49 subjects examined on two separate occasions by each observer. The percentage of within observer agreement was 80% for Observer A (kappa = 0.73) and 62% for Observer B (kappa = 0.49) (P less than 0.04). Altogether, 71% (25 of 35) of within observer discordant readings were confined to only one category. These data, obtained from the screening phase of the study, will allow us to refine the outcome measure for the trial without introducing bias that could result from knowledge of the actual study results. The failure of conventional cancer treatments to impact significantly on overall cancer mortality has led to an emphasis on prevention. If premalignant changes can be reliably detected at a time when the malignant process is reversible, then it may be feasible to intervene to prevent the occurrence of some cancers. The appropriate selection of subjects for such intervention trials and the subsequent demonstration of the efficacy of chemoprevention strategies are therefore crucial.
Comparison of frequency of radial artery occlusion after 4Fr versus 6Fr transradial coronary intervention (from the Novel Angioplasty USIng Coronary Accessor Trial).

The frequency of radial artery occlusion was compared between patients receiving 4Fr versus 6Fr transradial coronary interventions (TRIs) in an open-label randomized trial (ClinicalTrials.gov identifier: NCT00815997). The primary outcome measure was radial artery occlusion on the day after TRI. The secondary outcome measures were the procedural success, major advanced cardiac events, access site-related complications, procedural times, fluoroscopy times, and contrast dye usage. A total of 160 patients were included. The procedure was successful in 79 of 80 patients (99%) in both groups. Whereas the 4Fr group showed no access site-related complications, the 6Fr developed 5 (6%), including 3 radial artery occlusions and 2 bleedings (1 radial artery perforation and 1 massive hematoma; p = 0.02). Although the radial artery occlusion rate was lower in the 4Fr versus the 6Fr groups, the difference was not significant (0% vs 4%, p = 0.08). The mean hemostasis time was significantly shorter in the 4Fr than in the 6Fr groups (237 ± 105 vs 320 ± 238 minutes, p = 0.007). In conclusion, these findings suggest that 4Fr TRI may become a less invasive alternative to 6Fr TRI in treating coronary artery diseases.
A randomized, double-blind, placebo-controlled trial and open-label extension study to evaluate the efficacy and safety of pregabalin in the treatment of neuropathic pain associated with human immunodeficiency virus neuropathy

The objective of these studies was to assess the efficacy and safety of pregabalin in the treatment of human immunodeficiency virus (HIV)-associated neuropathic pain. Patients with HIV-associated distal sensory polyneuropathy (DSP) were randomized to treatment with flexible-dose pregabalin (150-600 mg/day) or placebo for 17 weeks in a single-blind, placebo lead-in, randomized, double-blind, parallel-group, placebo-controlled multinational trial. The primary efficacy outcome was the change in mean pain score on an 11-point numeric rating scale (NRS) from baseline to study endpoint. Participants who completed this trial were invited to participate in a 6-month open-label extension study with pregabalin. Of the 377 patients enrolled in the randomized controlled trial (pregabalin, n=183; placebo, n=194), 68.4% completed treatment. In the open-label extension, 217 patients were treated and 59.4% completed treatment. Both studies were terminated by the sponsor after a preplanned interim analysis indicated trial futility. At endpoint, the change from baseline in least-squares mean NRS pain scores in the intent-to-treat population was -2.04 for pregabalin versus -2.11 for placebo (P=.709). There were no significant differences between the pregabalin and placebo groups in the secondary efficacy measures. Incidence of adverse events was lower than seen in previous pregabalin studies. Overall, this trial did not show pregabalin to be more efficacious than placebo in treating HIV-associated DSP. Studies such as these, which fail to support their primary hypotheses, may be important in informing the methodology of future trials, especially when novel approaches to limit variability in the control group are included.
Enhanced Psychosocial Support for Caregiver Burden for Patients With Chronic Kidney Failure Choosing Not to Be Treated by Dialysis or Transplantation: A Pilot Randomized Controlled Trial.

Family caregivers of patients with chronic kidney failure have increased burden, as reflected by their high frequency of physical and mental disturbances. The impact of enhanced psychosocial support to caregivers of patients with chronic kidney failure remains unclear.



Open-label randomized controlled trial.



All new patients referred to the renal palliative clinic were screened. Caregivers of patients who met the following criteria were recruited: (1) chronic kidney failure as defined by creatinine clearance < 15 mL/min, (2) opted for conservative management by nephrology team or patient, (3) never treated with dialysis or transplantation, and (4) able to provide informed consent.



Random assignment to treatment with enhanced psychosocial support or standard renal care (control). Enhanced psychosocial support included counseling and psychosocial interventions by an on-site palliative care nurse and designated social worker. Each caregiver was followed up at 2- to 4-week intervals for up to 6 months.



Zarit Burden Inventory (ZBI) and Hospital Anxiety and Depression Scale (HADS) in caregivers and McGill Quality of Life scores in patients of both groups were compared.



29 pairs of family caregivers/patients with chronic kidney failure were randomly assigned (intervention, n=14; control, n=15). Mean ages of patients and caregivers were 81.6 ± 5.1 and 59.8 ± 14.2 (SD) years, respectively. The intervention group showed significantly lower ZBI scores than the control group at 1 and 3 months (22.0 ± 5.3 vs 31.6 ± 9.5 and 21.3 ± 6.6 vs 33.4 ± 7.2; P=0.006 and P=0.009, respectively). HADS anxiety scores of caregivers who received the intervention were significantly lower than those of controls at 1 and 3 months (7.1 ± 3.2 vs 10.1 ± 2.2 and 6.5 ± 4.5 vs 11.0 ± 3.1; P=0.01 and P=0.03, respectively). Insignificant reductions in ZBI and HADS scores were found at 6 months. 19 patients died (intervention, n=10; control, n=9) during the study period.



The study is limited by a relatively small sample size and short duration.



Enhanced psychosocial support program in patients with chronic kidney failure and caregivers resulted in an early significant reduction in caregiver burden and anxiety.
Comparison of the immunogenicity and safety of pentavalent vaccine Quinvaxem in a compact prefilled auto-disabled (cPAD) injection system versus single-dose vials in healthy infants: a phase 3, open-label, randomized, parallel-group, non-inferiority study.

To evaluate non-inferiority of three doses of Quinvaxem in a compact prefilled auto-disabled (cPAD) injection system versus Quinvaxem in a single-dose vial administered with conventional syringe in terms of seroconversion/seroprotection rates for all antibodies (anti-hepatitis B (HB), anti-Haemophilus influenzae type b polyribosylribitol phosphate (Hib PRP), anti-diphtheria, anti-tetanus, anti-Bordetella pertussis) at 1 month after primary vaccination.



Four hundred healthy infants aged 42-65 days were randomized (1:1) to receive Quinvaxem in cPAD or single-dose vial at 6, 10, and 12 weeks of age. Blood samples were collected before vaccination and at 1 month after the third dose to determine seroconversion/seroprotection rates. Safety was assessed from solicited and unsolicited adverse events and serious adverse events (SAEs).



Of the 400 infants randomized, 395 (98.8%) received all three vaccine doses. In the cPAD vs. single-dose vial groups, seroprotection rates against Hib PRP (both 98.5%), HB (92.9% vs. 93.4%), diphtheria (100% vs. 99%), and tetanus toxoids (both 100%), and seroconversion against B. pertussis (95.4% vs. 97%) were ≥92% at 1 month after the third vaccination (lower limits of 95% confidence intervals simultaneously greater than -10%). Geometric mean concentrations exceeded seroprotection/seroconversion thresholds by large margins. The incidences of induration and erythema were comparable between the groups; tenderness was slightly higher in the cPAD group (85.5% vs. 76.5%). No vaccine-related SAEs occurred.



Quinvaxem in cPAD was non-inferior to single-dose vial with respect to seroprotection/seroconversion rates for all antibodies. Both presentations were well-tolerated.
Mechanisms of stent thrombosis analysed by optical coherence tomography: insights from the national PESTO French registry.

Angiography has limited value for identifying the causes of stent thrombosis (ST). We studied a large cohort of patients by optical coherence tomography (OCT) to explore ST characteristics and mechanisms.



A prospective multicentre registry was screened for patients with confirmed ST. Optical coherence tomography was performed after initial intervention to the culprit lesion (in 69% of cases in a deferred procedure). Stent thrombosis was classified as acute (AST), sub-acute (SAST), late (LST), and very late (VLST). Optical coherence tomography records were analysed in a central core lab. The analysis included 120 subjects aged 61.7 [51.4-70.7]; 89% male. Very late ST was the clinical presentation in 75%, LST in 6%, SAST in 15%, and AST in 4% of patients. Bare metal stents (BMS) were used in 39%, drug-eluting stents (DES) in 59% and bioresorbable vascular scaffolds in 2% of the cases. Optical coherence tomography identified an underlying morphological abnormality in 97% of cases, including struts malapposition (34%), neoatherosclerotic lesions (22%), major stent underexpansion (11%), coronary evagination (8%), isolated uncovered struts (8%), edge-related disease progression (8%), and neointimal hyperplasia (4%). Ruptured neoatherosclerotic lesions were more frequent with BMS than with DES (36 vs. 14%, P = 0.005), whereas coronary evaginations were more frequent with DES than with BMS (12 vs. 2%, P = 0.04). LST + VLST were mainly related to malapposition (31%) and neoatherosclerosis (28%), while prominent mechanisms for AST + SAST were malapposition (48%) and underexpansion (26%).



In patients with confirmed ST, OCT imaging identified an underlying morphological abnormality in 97% of cases.
Prospective comparison of two Sengstaken tubes in the management of patients with variceal haemorrhage.

To compare the efficacy of two oesophageal tamponade tubes, 28 patients with endoscopically proven actively bleeding varices were randomly allocated to be intubated with either a newly available 4-lumen tube incorporating an extra lumen for oesophageal suction, or the modified 3-lumen Sengstaken tube. The patients and the nursing staff preferred using the 4-lumen tube and both aspiration pneumonias and balloon dysfunction occurred less frequently. Variceal haemorrhage was successfully controlled for the first 12 hours in most patients in the two treatment groups, although the incidence of re-bleeding at 48 hours after the tube had been deflated was high.
Comparison of interactive voice response, patient mailing, and mailed registry to encourage screening for osteoporosis: a randomized controlled trial

Guidelines recommend screening for osteoporosis with bone mineral density (BMD) testing in menopausal women, particularly those with additional risk factors for fracture. Many eligible women remain unscreened. This randomized study demonstrates that a single outreach interactive voice response phone call improves rates of BMD screening among high-risk women age 50–64. Osteoporotic fractures are a major cause of disability and mortality. Guidelines recommend screening with BMD for menopausal women, particularly those with additional risk factors for fracture. However, many women remain unscreened. We examined whether telephonic interactive voice response (IVR) or patient mailing could increase rates of BMD testing in high risk, menopausal women. We studied 4,685 women age 50–64 years within a not-for-profit health plan in the United States. All women had risk factors for developing osteoporosis and no prior BMD testing or treatment for osteoporosis. Patients were randomly allocated to usual care, usual care plus IVR, or usual care plus mailed educational materials. To avoid contamination, patients within a single primary care physician practice were randomized to receive the same intervention. The primary endpoint was BMD testing at 12 months. Secondary outcomes included BMD testing at 6 months and medication use at 12 months. Mean age was 57 years. Baseline demographic and clinical characteristics were similar across the three study groups. In adjusted analyses, the incidence of BMD screening was 24.6 % in the IVR group compared with 18.6 % in the usual care group (P < 0.001). There was no difference between the patient mailing group and the usual care group (P = 0.3). In this large community-based randomized trial of high risk, menopausal women age 50–64, IVR, but not patient mailing, improved rates of BMD screening. IVR remains a viable strategy to incorporate in population screening interventions.
Autoantigen-specific regulatory T cells induced in patients with type 1 diabetes mellitus by insulin B-chain immunotherapy.

There is a growing body of evidence to suggest that the autoimmunity observed in type 1 diabetes mellitus (T1DM) is the result of an imbalance between autoaggressive and regulatory cell subsets. Therapeutics that supplement or enhance the existing regulatory subset are therefore a much sought after goal in this indication. Here, we report the results of a double blind, placebo controlled, phase I clinical trial of a novel antigen-specific therapeutic in 12 subjects with recently diagnosed T1DM. Our primary objective was to test its safety. The study drug, human insulin B-chain in incomplete Freund's adjuvant (IFA) was administered as a single intramuscular injection, with subjects followed for 2 years. All subjects completed therapy and all follow-up visits. The therapy was generally safe and well-tolerated. Mixed meal stimulated C-peptide responses, measured every 6 months, showed no statistical differences between arms. All patients vaccinated with the autoantigen, but none who received placebo, developed robust insulin-specific humoral and T cell responses. Up to two years following the single injection, in peripheral blood from subjects in the experimental arm, but not the control arm, insulin B-chain-specific CD4+ T cells could be isolated and cloned that showed phenotypic and functional characteristics of regulatory T cells. The induction of a lasting, robust immune response generating autoantigen-specific regulatory T cells provides strong justification for further testing of this therapy in type 1 diabetes.
Totaled health risks in vascular events score predicts clinical outcome and symptomatic intracranial hemorrhage in chinese patients after thrombolysis.

The performance of the Totaled Health Risks in Vascular Events (THRIVE) score in predicting clinical outcomes in Chinese patients with acute ischemic stroke post intravenous thrombolysis is unknown.



Data from the Thrombolysis Implementation and Monitor of Acute Ischemic Stroke in China (TIMS-China) study was used to compare the THRIVE score with other scores used to predict clinical outcomes and symptomatic intracranial hemorrhage after intravenous thrombolysis.



Among the 1128 patients with acute ischemic stroke who were included in this study, areas under the curve of the THRIVE score for symptomatic intracranial hemorrhage, 3-month poor functional outcomes, and death rate were 0.69, 0.71, and 0.78, respectively. The increased THRIVE score was related to the higher risk of developing symptomatic intracranial hemorrhage, poor functional outcomes, or death in patients with acute ischemic stroke at 3 months after thrombolysis.



The THRIVE score predicted reliably the risks of developing symptomatic intracranial hemorrhage, poor functional outcome, or death after intravenous thrombolysis therapy in Chinese patients with acute ischemic stroke.
Effectiveness of focused meditation for patients with chronic low back pain-A randomized controlled clinical trial.

We aimed to evaluate the effectiveness of an 8-week meditation program (focused meditation) in patients with chronic low-back pain.



A randomized clinical trial was conducted on 68 patients (55 years;75% female) with chronic low-back pain who scored >40mm on a 100mm Visual-Analogue-Scale. Subjects were allocated to an 8-week meditation program (focused meditation) with weekly 75min classes or to a self-care exercise program with a wait-list offer for meditation. Both groups were instructed to practice at home. Outcomes were assessed baseline and after 4 and 8 weeks. The primary outcome measure was the change in mean back pain at rest after 8 weeks. Secondary outcomes included function, pain-related bothersomeness, perceived stress, quality-of-life (QOL), and psychological outcomes.



Twelve (meditation) and 4 (exercise) patients were lost to follow-up. The primary outcome, pain at rest after 8 weeks, was reduced from 59.3±13.9mm to 40.8±21.8mm with meditation vs. 52.9±11.8mm to 37.3±18.2mm with exercise (adjusted group difference: -1.4 (95%CI:11.6;8.8;p=n.s.) Perceived stress was significantly more reduced with meditation (p=0.011). No significant treatment effects were found for other secondary outcomes as pain-related bothersomeness, function, quality-of-life and psychological scores, although the meditation group consistently showed non-significant better improvements compared to the exercise group.



Focused meditation and self-care exercise lead to comparable, symptomatic improvements in patients with chronic low back pain. Future studies should include longer-term follow-ups and develop guided meditation programs to support compliance.
Rapid Protection against Hepatitis A and B Using an Accelerated Vaccination Schedule

1 Department of Infectious Diseases and Tropical Medicine, Ludwig-Maximilians University, Munich, Germany 2 Department of Medicine, Bernhard-Nocht Institute for Tropical Medicine, Hamburg, Germany 3 Academic Centre for Travel Medicine & Vaccines, Royal Free and University College Medical School, University College London, London, UK 4 Institute of Tropical Medicine, University Hospital, Tübingen, Germany 5 University Hospital and Medical Center, Ulm, Germany 6 GlaxoSmithKline GmbH & Co. KG, Munich, Germany SHORT COMMUNICATION Biodrugs 2003; 17 Suppl. 1: 15-18 1173-8804/03/0001-0015/$30.00/0