nils-herrmann/clean_scirepeval huggingface dataset:
Successful mobilization of PBSCs predicts favorable outcomes in multiple myeloma patients treated with novel agents and autologous transplantation

Incorporation of novel agents into auto-SCT for patients with multiple myeloma has led to improvement in their outcomes. However, the effects of new drugs, either single or combined, on PBSC mobilization have not been fully evaluated, particularly in phase 3 clinical studies. We analyzed the impact of two novel agent-based induction treatments in patients enrolled in the GIMEMA MMY-3006 study comparing bortezomib, thalidomide and dexamethasone (VTD) versus thalidomide and dexamethasone (TD) in preparation for double auto-SCT. Results showed that a short-term induction therapy with VTD did not adversely affect CD34+ cell yields as compared with TD (9.75 vs 10.76 × 106 CD34+ cells/kg, P=0.220). For poor mobilizers (<4 × 106 CD34+ cells/kg), 5-year rates of time to progression (TTP), progression-free survival (PFS) and overall survival (OS) were significantly shorter than for successful mobilizers (TTP:17 vs 48%, P<0.0001; PFS: 16 vs 46%, P<0.0001; OS: 50 vs 80%, P<0.0001). These differences were retained across patients randomized to the TD arm; conversely, no differences in outcomes were seen in patients treated with VTD, irrespective of the number of harvested CD34+ cells. The number of collected PBSCs predicted better outcomes after auto-SCT and VTD overcame the negative impact of a poor stem cell mobilization.
Prevalence of extrauterine pelvic lesions on transvaginal ultrasound in asymptomatic 20-39-year-old women.

To estimate the prevalence of extrauterine pelvic lesions on transvaginal ultrasound examination of gynecologically asymptomatic women of fertile age, and to compare this prevalence between women with spontaneous menstrual cycles, those using the combined oral contraceptive (COC) pill and those using a gestagen intrauterine contraceptive device (IUD).



Six hundred and forty-four gynecologically asymptomatic 20-39-year-old Caucasian women with no current or previous gynecological problems, who were recruited from a Swedish population registry, were examined with transvaginal ultrasound on cycle day 4-8. Our definition of ovarian cyst was a unilocular cyst with anechoic cyst contents ≥ 35 mm in mean diameter, or any other type of intraovarian lesion. The prevalence of extrauterine pelvic lesions was compared between women not using hormonal contraception and those using COC or a gestagen IUD.



Ovarian lesions were found in 24 (3.7%) women. One woman had bilateral ovarian lesions. An ultrasound diagnosis of paraovarian cyst was made in 41 (6.4%) women, of peritoneal cyst in four (0.6%) women and of hydrosalpinx in one (0.2%) woman. All incidentally detected lesions had a mean diameter of ≤ 5 cm. One 17-mm intraovarian lesion was suspicious for malignancy, and histology confirmed a Sertoli-Leydig cell tumor. The ultrasound diagnoses in the remaining 23 women were endometrioma (n = 10 (1.6%)), dermoid cyst (n = 5 (0.8%)), cystadenofibroma (n = 1 (0.2%)), mature teratoma (n = 1 (0.2%)) and functional cyst, i.e. a cyst that resolved within 3-5 months (n = 6 (0.9%)). Four women with an ultrasound diagnosis of a benign lesion were operated on, and the ultrasound diagnoses of endometrioma (n = 2), dermoid cyst (n = 1) and mature teratoma (n = 1) were confirmed histologically. The prevalence of persisting ovarian lesions was highest in women with spontaneous menstrual cycles (4.4% vs 0.9% and 0% in women using COC and gestagen IUD, respectively; P = 0.025), but age was the only factor independently associated with persisting ovarian masses, the prevalence increasing with age.



Benign ovarian lesions are found in about 1 in 25 gynecologically asymptomatic women aged 20-39 years with no history of gynecological disease. To be able to offer optimal management of such masses, their natural history needs to be elucidated in a large prospective observational study.
Co-expression of PD-1 and PD-L1 predicts poor outcome in nasopharyngeal carcinoma.

Tumor immune evasion is a hallmark of cancer. The programmed death-1/programmed death-ligand 1 (PD-1/PD-L1) pathway has been suggested to play an important role in T cell tolerance and tumor immune escape. In this study, we aimed to evaluate the correlation between the expression of PD-1/PD-L1 and the post-treatment outcome in patients with nasopharyngeal carcinoma (NPC). Formalin-fixed, paraffin-embedded tissue biopsies from 139 patients with histological diagnosis of NPC treated with conventional chemoradiotherapy were studied. By using immunohistochemistry staining, expressions of PD-1 on tumor-infiltrating lymphocyte and PD-L1 on tumor tissue were detected. The staining results were evaluated with H-score. The correlation between PD-1/PD-L1 expression and clinical characteristics and post-treatment outcome were analyzed. PD-1(+) immune cell were present in 52 of these 139 tumors (37.4%). PD-L1 expression was detected in 132 patients (95.0%), which located on tumor tissue. High expression of PD-L1 (median H-score >35) in tumor tissue significantly correlated with a poor prognosis of disease-free survival (P = 0.009). Co-expression of PD-1 and PD-L1 in NPC at diagnosis correlated with the poorest prognosis of disease-free survival (P = 0.038). PD-1/PD-L1 co-expression reflected the selective suppression of cytotoxic lymphocytes in the tumor microenvironment and predicted recurrence and metastasis of NPC after conventional therapies. Blocking this pathway in patients with co-expression of PD-1/PD-L1 provides a potential therapy target for NPC.
Francaise d ' Oncologie Pediatrique LMB 89 protocol : highly effective multiagent chemotherapy tailored to the tumor burden and initial response in 561 unselected children with B-cell lymphomas and L 3 leukemia

Lacombe, M-J. (2001). The Societe Francaise d'Oncologie Pediatrique LMB89 protocol: highly effective multiagent chemotherapy tailored to the tumor burden and initial response in 561 unselected children with B-cell lymphomas and L3 leukemia. Blood, 97(11), 3370-3379.  10.1182/blood.
Obsessions of infanticide and imminent psychosis.

In young mothers an obsession of infanticide, that is, fear that they may murder their children, may be coupled with an obsession of imminent psychosis, that is, fear that the first obsession is a sign of approaching insanity. Sixteen mothers with this clinical picture were evaluated in interviews. Seven of them entered psychotherapy and improved. The causative factors in childhood and adolescence wich led to the later development of these obsessive difficulties are analyzed. Even when psychotherapy was not possible, as was the case in nine patients, they should be strongly reassured and explanations should be given about the nature of the problem, for such encouragement and clarification helps them to improve to a significant extent. The prognosis of patients who have systematic psychoterapy is good.
Laparoscopic lateral adrenalectomy versus open posterior adrenalectomy for the treatment of benign adrenal tumors

Minimally invasive techniques play an important role in adrenal gland surgery. The objective of this study was to compare laparoscopic transabdominal adrenalectomy in the lateral position to the open posterior adrenalectomy with respect to the intraoperative and the short-term postoperative course.  Forty laparoscopic adrenalectomies (LA) carried out between July 1998 and August 2001 were compared to 30 open posterior operations (PA) performed between July 1994 and June 1998. In all cases the indications for surgery was a benign lesion smaller than 8 cm.  Age, gender, tumor size, and distribution of the tumor histology were comparable in both groups (LA vs PA). In favor of LA, statistically significant differences (p <0.05) were observed regarding the intraoperative blood loss (260 vs 380 mL), the postoperative narcotic equivalents (2.9 vs 6.4 mg), the morbidity rate (13 vs 27%), and the length of hospital stay (7 vs 10 days). Average operating time was significantly longer for LA (135 vs 106 min). There were two conversions to open adrenalectomy due to diffuse bleeding. Following LA, we observed one major complication (postoperative bleeding from the spleen making a laparotomy necessary) and four minor complications (one small retroperitoneal hematoma, two subcostal nerve irritations, one pleural effusion). PA resulted in one major (wound infection) and seven minor complications (two subcutaneous hematomas, two nerve irritations, two pleural effusions, one dystelectasis).  Laparoscopic adrenalectomy proved as a safe and reliable procedure, displaying all advantages of minimal access surgery. In our institution, it has become the standard technique employed for benign adrenal disease. However, the operation is technically demanding, and as adrenal surgery is rare, it should be restricted to centers with special interest in laparoscopic and endocrine surgery.
Development and Psychometric Properties of a Scale to Measure Hospital Organizational Culture for Cardiovascular Care.

Because organizational culture is increasingly understood as fundamental to achieving high performance in hospital and other healthcare settings, the ability to measure this nuanced concept empirically has gained importance. Aside from measures of patient safety culture, no measure of organizational culture has been widely endorsed in the medical literature, limiting replication of previous findings and broader use in interventional studies.



We sought to develop and assess the validity and reliability of a scale for assessing organizational culture in the context of hospitals' efforts to reducing 30-day risk-standardized mortality after acute myocardial infarction. The 31-item scale was completed by 147 individuals representing 10 hospitals during August and September 2014. The resulting organizational culture scale demonstrated high level of construct validity and internal consistency. Factor analyses indicated that the 31 items loaded well (loading values 0.48-0.90), supporting distinguishable domains of (1) learning environment, (2) psychological safety, (3) commitment to the organization, (4) senior management support, and (5) time for improvement efforts. Cronbach α coefficients were 0.94 for the scale and ranged from 0.77 to 0.88 for the subscales. The scale displayed reasonable convergent validity and statistically significant variability across hospitals, with hospital identity accounting for 11.3% of variance in culture scores across respondents.



We developed and validated a relatively easy-to-administer survey that was able to detect substantial variability in organizational culture across different hospitals and may be useful in measuring hospital culture and evaluating changes in culture over time as part performance improvement efforts.
Oral ganciclovir for treatment of lamivudine-resistant hepatitis B virus infection: a pilot study.

Although liver disease seems to be stable in most patients who are infected with lamivudine-resistant mutant hepatitis B virus (HBV) in the short term, it may progress to more-advanced disease in some patients. In our pilot study, we investigated the efficacy of oral ganciclovir for the treatment of lamivudine-resistant HBV infection. Six patients infected with lamivudine-resistant HBV (3 patients had decompensated cirrhosis and 3 had chronic active hepatitis without cirrhosis) were included. Ganciclovir was administered at a dosage of 3 g daily for 6 months. Four of 6 patients completed the 6-month treatment period. Two patients with cirrhosis completed only 2 months of ganciclovir treatment because they died of cirrhosis complications. None of the patients had a > or =2-log(10) reduction of HBV DNA and complete alanine aminotransferase normalization at the end of their treatment regimens. In conclusion, 6 months of ganciclovir treatment is not effective for suppression of lamivudine-resistant HBV infection.
A hinged external fixator for complex elbow dislocations: A multicenter prospective cohort study

Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures of the radial head, olecranon, or coronoid process. The majority of patients with these complex dislocations are treated with open reduction and internal fixation (ORIF), or arthroplasty in case of a non-reconstructable radial head fracture. If the elbow joint remains unstable after fracture fixation, a hinged elbow fixator can be applied. The fixator provides stability to the elbow joint, and allows for early mobilization. The latter may be important for preventing stiffness of the joint. The aim of this study is to determine the effect of early mobilization with a hinged external elbow fixator on clinical outcome in patients with complex elbow dislocations with residual instability following fracture fixation.



The design of the study will be a multicenter prospective cohort study of 30 patients who have sustained a complex elbow dislocation and are treated with a hinged elbow fixator following fracture fixation because of residual instability. Early active motion exercises within the limits of pain will be started immediately after surgery under supervision of a physical therapist. Outcome will be evaluated at regular intervals over the subsequent 12 months. The primary outcome is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford Elbow Score, pain level at both sides, range of motion of the elbow joint at both sides, radiographic healing of the fractures and formation of periarticular ossifications, rate of secondary interventions and complications, and health-related quality of life (Short-Form 36).



The outcome of this study will yield quantitative data on the functional outcome in patients with a complex elbow dislocation and who are treated with ORIF and additional stabilization with a hinged elbow fixator.
Early hyperbaric oxygen therapy for reducing radiotherapy side effects: early results of a randomized trial in oropharyngeal and nasopharyngeal cancer.

Comparison of quality of life (QoL) and side effects in a randomized trial for early hyperbaric oxygen therapy (HBOT) after radiotherapy (RT).



From 2006, 19 patients with tumor originating from the tonsillar fossa and/or soft palate (15), base of tongue (1), and nasopharynx (3) were randomized to receive HBOT or not. HBOT consisted of 30 sessions at 2.5 ATA (15 msw) with oxygen breathing for 90 min daily, 5 days per week, applied shortly after the RT treatment was completed. As of 2005, all patients received validated questionnaires (i.e., the European Organization for Research and Treatment of Cancer [EORTC] QLQ-C30, EORTC QLQ Head and Neck Cancer Module (H&N35), Performance Status Scale): before treatment; at the start of RT treatment; after 46 Gy; at the end of RT treatment; and 2, 4, and 6 weeks and 3, 6, 12, and 18 months after follow-up.



On all QoL items, better scores were obtained in patients treated with hyperbaric oxygen. The difference between HBOT vs. non-HBOT was significant for all parameters: EORTC H&N35 Swallowing (p = 0.011), EORTC H&N35 Dry Mouth (p = 0.009), EORTC H&N35, Sticky Saliva (p = 0.01), PSS Eating in Public (p = 0.027), and Pain in Mouth (visual analogue scale; p < 0.0001).



Patients randomized for receiving hyperbaric oxygen after the RT had better QoL scores for swallowing, sticky saliva, xerostomia, and pain in mouth.
Differential effects of HIV viral load and CD4 count on proliferation of naive and memory CD4 and CD8 T lymphocytes.

We previously showed that HIV infection leads to expansion of a rapidly proliferating pool (s(1)) of CD4 and CD8 T lymphocytes. In the current study, we used in vivo labeling with bromodeoxyuridine to characterize the kinetics of naive, memory, and activated (HLA-DR(+)/CD38(+)) subpopulations of CD4 and CD8 T lymphocytes, and to examine the relationship between kinetic parameters and baseline CD4 counts, HIV viral load, potential markers of microbial translocation, and cytokine levels. Activated cells showed the highest proliferation rates, followed by effector and central memory cells, with naive cells showing the lowest rates, for both CD4 and CD8 T cells. HIV viral load correlated with s(1) of CD4 and CD8 effector memory cells, as well as CD8 naive cells, whereas CD4 cell counts correlated inversely with naive CD4 s(1). Endotoxin levels showed a weak negative association with CD4 but not CD8 s(1). INF-γ and TNF-α were associated with s(1) for CD4 and CD8 cells, respectively. Thus, HIV is the primary driving force behind the activation and proliferation of most subsets of both CD4 and CD8 T lymphocytes, whereas naive CD4 cell proliferation likely represents a homeostatic response. Microbial translocation does not appear to play an important role in this proliferation.
A cluster randomized trial to evaluate the efficacy of a school-based behavioral intervention for health promotion among children aged 3 to 5

The onset of inadequate behaviors leading to the development of risk factors for chronic diseases is known to occur early in life. An effective program for health promotion should therefore focus on children and their environment, as the starting point for behavior development. The overarching objective of the Program SI! (Salud Integral - Comprehensive Health) is to intervene at the school level, to establish and develop life-lasting habits that will help preserving health during adulthood. The Program SI! comprises five consecutive subprograms according to the five stages of education in Spain, the first being in preschoolers. This study aims to evaluate the efficacy of Program SI! to establish and improve lifestyle behaviors in children (preschoolers aged 3-5 years), their parents, and teachers, and also improving the school environment. A secondary objective is to evaluate improvements in cardiovascular health-related markers (anthropometric parameters, blood pressure, and dietary and physical activity patterns) in these same children.



24 public schools from the city of Madrid (Spain) were allocated through stratified randomization to intervention or control. The intervention schools follow the Program SI!, which provides didactic units, emotions cards, healthy tips, and online resources. The intervention schools integrate the Program SI! into their scholar curriculum organized in four complete weeks during each academic year during the 3 years of preschool education. Control schools follow their normal curriculum. Primary outcomes are 1-year, and 3-year changes from baseline of scores for knowledge, attitudes, and habits (KAH) of children, their parents and teachers in regards to a healthy lifestyle. Secondary outcomes are 1-year, and 3-year changes from baseline in clinical and anthropometric parameters of children.



The Program SI! is a long-term health promotion program starting in 3 years old. It incorporates the traditional areas of intervention (diet and physical activity), introducing additional components such as knowledge of the human body and management of emotions to achieve a comprehensive intervention. The Program SI! is designed to be an effective, sustainable health promotion program for the adoption of healthy behaviors from early in life.
Impact of the pre-transplant histological score on 3-year graft outcomes of kidneys from marginal donors: a single-centre study.

The reliability of kidney biopsy as the sole means for assessing kidneys from extended-criteria donors (ECDs) to be allocated to single or dual transplantation is still a matter of debate.



We compared retrospectively 3 years graft survival and renal function in 44 recipients of a single kidney graft from a marginal donor with good renal function and a Karpinski histological score of ≤ 3 and 56 recipients of a single transplant with a Karpinski score of 4 or 5. The donors' and recipients' characteristics were compared by means of Wilcoxon's rank-sum test and Fisher's exact test, and survival was analysed using the log-rank test and Cox regression survival analysis.



The donors with the worse histological scores were slightly younger (68.0 ± 4.74 versus 71.3 ± 4.6 years, P < 0.01) and had a higher glomerular filtration rate (85.8 ± 28.2 versus 76.3 ± 26.53 mL/min, P = 0.013), but there was no difference in serum creatinine levels (0.83 ± 0.24 versus 0.85 ± 0.30 mg/dL, P = 0.381). Three years after transplantation, there was no difference between the two groups in terms of recipient serum creatinine levels (1.94 ± 0.69 versus 1.74 ± 0.49 mg/dL, P = 0.134), estimated glomerular filtration rate (eGFR, 45.6 ± 21.1 versus 51.7 ± 22.0 mL/min, P = 0.331) or the rates of graft loss (27.3 versus 35.7%, P = 0.47), delayed graft function or acute rejection.



In our experience, provided the donor has a normal renal function, a difference in the pre-transplant histological score of kidneys from marginal cadaveric donors do not have a significant influence on the outcome 3 years after transplantation. Our findings might represent a basis for designing a randomized controlled trial of using a higher histological score threshold for the DKT allocation of grafts from ECDs with a normal renal function.
Electrophysiological, hemodynamic, and metabolic response to open procedure or endovascular repair of infrarenal aortic aneurysms.

The occurrence of cardiovascular diseases in the group of patients undergoing vascular surgery because of abdominal aorta aneurysm is very high. Endovascular procedures are regarded as hemodynamically safer for the patients. The aim of this study was to compare the changes in electrophysiological, hemodynamic, and metabolic parameters depending on the type of operation, using invasive hemodynamic monitoring and Holter electrocardiography recording.



A prospective, observational, nonrandomized study was conducted to compare dynamic changes of electrophysiological parameters (dominant rhythm, arrhythmia, corrected QT interval (QTc), invasive blood pressure, electrolytes, and acid-base balance in defined points during perioperative time in 2 groups: vascular prosthesis implantation group (91 patients) and stent-graft implantation group (83 patients).



The study group comprised 174 consecutive adult Caucasian patients (mean age 64.4 ± 8.9 years in stent-graft group and 70.0 ± 7.5 years in vascular prosthesis implantation group). Although patients in the stent-graft implantation group were younger, they were diagnosed with lower limbs vascular atherosclerosis, type 2 diabetes mellitus, and a lower left ventricle ejection fraction more often than patients in the open procedure group. During the open procedure, higher blood pressure amplitudes (P = 0.00009), higher decrease in pH (P = 0.049), increase in the arterial lactate level (P = 0.00002), prolonged QTc values (P = 0.001), more frequent ventricular extrasystoles (P = 0.005), and cardiovascular deaths were observed, when compared with those observed during the endovascular aneurysm repair.



When compared with the chosen techniques, the one for infrarenal abdominal aneurysm was found to be associated with significant differences in electrophysiological, hemodynamic, and metabolic parameters.