nils-herrmann/clean_scirepeval huggingface dataset:
Use of distress and depression thermometers to measure psychosocial morbidity among southern European cancer patients

Recent literature has indicated the need for rapid evaluation of psychosocial issues secondary to cancer. Because of the problems of routine use of psychometric instruments, short instruments such as visual analogue scales or one-item 0–10 scales have been developed as valid assessment alternatives. A study was conducted to examine the role of two 0–10 scales in measuring emotional stress (distress thermometer, DT) and depressed mood (mood thermometer, MT), respectively, in a multicenter study carried out in southern European countries (Italy, Portugal, Spain, and Switzerland). A convenience sample of 312 cancer outpatients completed the DT and MT and the Hospital Anxiety Depression Scale (HADS). DT was more significantly associated HADS anxiety than HADS depression while MT was related both to HADS anxiety and depression. The correlation of MT with HADS was higher than DT. A cutoff point >4 on the DT maximized sensitivity (65%) and specificity (79%) for general psychosocial morbidity while a cutoff >5 identified more severe “caseness” (sensitivity=70%; specificity=73%). On the MT, sensitivity and specificity for general psychosocial morbidity were 85% and 72% by using the cutoff score >3. A score >4 on the MT was associated with a sensitivity of 78% and a specificity of 77% in detecting more severe caseness. Two simple instruments, the DT and the MT, were found to have acceptable levels of sensitivity and specificity in detecting psychosocial morbidity. Compared to the HADS, however, the mood MT performed better than the DT.
Intravenous micronutrient therapy (Myers' Cocktail) for fibromyalgia: a placebo-controlled pilot study.

Intravenous micronutrient therapy (IVMT), and specifically the Myers' Cocktail, is a popular approach for treating fibromyalgia syndrome (FMS) among complementary and alternative medicine practitioners, but its efficacy is uncertain. This trial assessed the feasibility, safety, and provided insights into the efficacy of this therapy.



This was a randomized, double-blind, placebo-controlled pilot study.



The study locations were an academic research center, teaching hospital, and affiliated Integrative Medicine Center in Derby, CT.



The subjects were 34 adults with American College of Rheumatology (ACR)-defined FMS.



Subjects were randomly assigned either to treatment (weekly infusions of IVMT) or to placebo (weekly infusions of lactated Ringer's solution) for 8 weeks.



Primary outcome was change in the Tender Point Index, assessed 8 and 12 weeks after initiation. Secondary measures included a Visual Analog Scale to assess global pain, and validated measures of physical function (Fibromyalgia Impact Questionnaire), mood (Beck Depression Index), and quality of life (Health Status Questionnaire 2.0).



Clinically significant improvements were noted (of a magnitude similar to other effective interventions). However, in part because of the high placebo response and the small sample size, no statistically significant differences were seen between groups, in any outcome measure, at 8 and 16 weeks. Statistically significant within-group differences were seen in both the intervention and placebo groups, demonstrating a treatment effect for both IVMT and placebo. At 8 weeks, the IVMT group experienced significantly improved tender points, pain, depression, and quality of life directly following treatment (all p < or = 0.02), while the placebo group experienced significantly improved tender points only (p < or = 0.05). The treatment effects of IVMT persisted at 4 weeks postintervention for tender points, pain, and quality of life, while placebo effects persisted only for tender points. A single minor adverse event was noted in one subject in the intervention group.



This first controlled pilot study established the safety and feasibility of treating FMS with IVMT. Most subjects experienced relief as compared to baseline, but no statistically significant differences were seen between IVMT and placebo. The efficacy of IVMT for fibromyalgia, relative to placebo, is as yet uncertain.
Gemcitabine plus dose-escalated epirubicin in advanced breast cancer: results of a phase I study

Gemcitabine has shown single-agent activity in metastatic breast cancer. Epirubicin is also widely used for the adjuvant and treatment of metastatic breast cancer. The toxicity profiles and modes of action are different which provides a good rationale for studying both drugs in combination. In a phase I study gemcitabine at a fixed dose of 1000 mg/m2 on days 1, 8, 15 of a 28 day cycle was combined with escalated weekly doses of epirubicin starting with an initial dose of 10 mg/m2. Patients had stage IV metastatic disease without previous chemotherapy except as adjuvant treatment. Nineteen patients were included in the study which defined the maximum tolerated dose (MTD) of epirubicin at 20 mg/m2. Myelosuppression was the dose limiting toxicity with leucopenia WHO grade 3 and 4 in 40.0% and 20.0%, neutropenia WHO grade 3 and 4 without neutropenic fever in 20.0% and 40.0% and thrombocytopenia WHO grade 4 in 20.0%. At the epirubicin 15 mg/m2 dose level, leucopenia (11.1% WHO grade 3) and neutropenia (12.5 and 37.5% WHO grade 3 and 4) were reported. Symptomatic toxicity was generally mild: nausea/vomiting in about 20% of patients (WHO grade 3 or 4) on both 15 and 20 mg/m2 epirubicin dose levels. Alopecia WHO grade 3 and 4 was seen in 2 patients at MTD. Four of 19 evaluable patients had a partial response. We conclude that the combination of gemcitabine and epirubicin is well tolerated and has promising activity. A phase II study is underway with gemcitabine 1000 mg/m2 and epirubicin 15 mg/m2 on days 1, 8 and 15 of a 28 day cycle.
Multiple-dose pharmacokinetics of intranasally administered IS-159 in healthy subjects

This study was designed to investigate the multiple — dose pharmacokinetics of a range of intransal doses of IS-159, a serotonin 1B/1D receptor agonist. Intranasal doses of 1, 2, 4 and 6 mg of IS-159 were administered twice at an interval of 4 hours to 17 healthy male and female subjects in a two-way crossover study. Plasma concentrations of IS-159 were determined from blood samples taken at regular intervals up to 24 hours after the first administration during both treatment periods. IS-159 was rapidly absorbed and eliminated with a tmax of approximately 15 min and a t1/2 of approximately 1.6 hours. With increasing dose, the exposure increased dose-proportionally, and IS-159 pharmacokinetics appear not to be influenced by gender and food intake. The results showed dose-proportional pharmacokinetics of IS-159 in the dose range tested and a low propensity for drug accumulation.
Radioimmunotherapy of prostate cancer using 90Y- and 177Lu-labeled J591 monoclonal antibodies: effect of multiple treatments on myelotoxicity.

Bone marrow is the dose-limiting organ in radioimmunotherapy. Fractionated dose regimens may decrease myelotoxicity and increase greater total administered dose. We have studied the effect of two or three treatments of 177Lu-J591 and 90Y-J591 monoclonal antibodies (mAb) on myelotoxicity.



J591 is a deimmunized anti-PSMA mAb. Seven groups of patients with prostate cancer (n = 35) received 10 to 75 mCi/m2 of 177Lu-J591 and five additional groups (n = 28) received 5 to 20 mCi/m2 of 90Y-J591. Fifteen patients received two to three treatments of 177Lu-J591 (30, 45, or 60 mCi/m2) and four patients received two or three doses of 90Y-J591 (17.5 or 20 mCi/m2). Re-treatment consisted of patients receiving the same 177Lu or 90Y dose as their initial cycle. Time between treatments was 2 to 4 months.



The single dose maximum tolerated dose was 70 mCi/m2 with 177Lu-J591 and 17.5 mCi/m2 with 90Y-J591. With a single dose of 177Lu, no severe toxicity was observed below 60 mCi/m2. With 177Lu, two doses of 45 or 60 mCi/m2, totaling 90 to 120 mCi/m2, proved to be quite toxic. Three doses of 30 mCi/m2 (total 90 mCi/m2), however, were well tolerated. With 90Y, four patients tolerated two to three doses of 17.5 or 20 mCi/m2. Thrombocytopenia increased at higher doses and after repeat treatments. At higher doses, the nadir was lower and the time to reach nadir was longer. Time for recovery of platelets seems related to the total dose.



Multiple (two or three) administrations of 177Lu-J591 (30-60 mCi/m2) or 90Y-J591 (17.5 mCi/m2) over a 4- to 6-month period were tolerated by the patients with manageable thrombocytopenia. Although a single large dose may deliver optimal radiation dose to kill a larger fraction of tumor cells, fractionated therapy offers the advantage of lower myelotoxicity and prolonged tumor response. With 177Lu-J591, dose fractionation in combination with taxanes should be considered as an alternative approach to achieve optimal therapeutic efficacy in patients with prostate cancer.
Effect of a Platelet-Activating Factor Receptor Antagonist , E 5880 , on Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage — Open Clinical Trial to Investigate Efficacy and Safety —

The efficacy and safety of a new platelet-activating factor receptor antagonist, E5880, were investigated for preventing cerebral vasospasm after subarachnoid hemorrhage (SAH) in 71 patients with SAH who underwent surgery for ruptured aneurysms within 3 days. Intravenous E5880 administration (300 mg or 1200 mg twice daily) was begun within 4 days and continued for 14 days. The incidence of symptomatic vasospasm, low-density area on computed tomography, and angiographic vasospasm was lower than in placebo groups in previous studies. Clinical outcome was favorable compared with previous studies. No clinically important adverse events were observed. These results suggest that E5880 is safe and effective in the treatment of patients with cerebral vasospasm due to SAH.
Phase I clinical evaluation of [SP-4-3(R)]-[1,1-cyclobutanedicarboxylato(2-)](2-methyl-1,4-butanediamine-N,N 1) platinum in patients with metastatic solid tumors

The development of clinically useful drugs is a priority of clinical cancer research. CI-973, [SP-4-3(R)]-[1,1-cyclobutanedicarboxylato(2-)](2-methyl-1,4-butanediamine-N,N 1) platinum, has been shown in preclinical murine and human tumor models to have activity equivalent or superior to that of cisplatin and carboplatin and to exert activity against cisplatin-resistant cell lines. In addition, preclinical testing suggests a reduced toxicity profile for CI-973 as compared with currently available drugs, especially decreased nephrotoxicity, ototoxicity, and gastrointestinal toxicity. A total of 29 (28 evaluable) patients with solid tumors were treated with intravenous CI-973 given over 30 min every 4 weeks. No routine pre- or posttreatment hydration or antiemetic program was used. The CI-973 doses given were 75, 150, 170, 188, 230, and 290 mg/m2. The dose-limiting toxicity was granulocytopenia. Nausea and vomiting occurred in the majority of patients but was mild to moderate in severity. No renal or auditory toxicity was seen. The maximum tolerated dose (MTD) for patients who had a good performance status, had not received prior radiation therapy to bone marrow, and had not previously been exposed to platinum or stem-cell toxin was 290 mg/m2. For those who had received prior radiation therapy, had a performance status of 2 or worse, or had previously been exposed to platinum or stem-cell toxin, the MTD was 230 mg/m2. The recommended phase II starting doses for these groups of patients are 230 and 190 mg/m2, respectively. No clinical tumor response was seen in this phase I study.
Effectiveness of online cognitive behavioral therapy on family caregivers of people with dementia

Family caregivers of persons with dementia (PWD) may receive caregiver training because of logistical constraints and privacy concerns. This study evaluated the effectiveness of an online intervention for family caregivers of PWD in improving their self-efficacy in managing behavioral and psychological symptoms of dementia (BPSD), and their emotion well-being.



A total of 36 family caregivers of people with dementia participated in a 9-week online intervention based on the cognitive behavioral therapy model. Outcomes of the intervention were measured by the Chinese version of the Neuropsychiatric Inventory Questionnaire and two domains of the Revised Scale for Caregiving Self-Efficacy. Wilcoxon signed rank tests were used to compare the change in outcome variables.



The severity of BPSD of PWD and BPSD-related distress in family caregivers showed a statistically significant reduction after the intervention. Subgroup analysis showed self-efficacy in controlling upsetting thoughts significantly improved in caregivers of PWD at moderate to severe stages.



Online cognitive behavioral therapy for family caregivers reduced BPSD of PWD and the related distress in their caregivers.
Phylogenetic tree based on complete genomes using fractal and correlation analyses without sequence alignment

The complete genomes of living organisms have provi ded much information on their phylogenetic relationship s. Similarly, the complete genomes of chloroplasts hav e helped resolve the evolution of this organelle in photosyn thetic eukaryotes. In this review, we describe two algorit hms to construct phylogenetic trees based on the theories f fractals and dynamic language using complete genomes. These algorithms were developed by our research group in the past few years. Our distance-based phylogenetic tree of 109 prokaryotes and eukaryotes agrees with the biologis ts’ “tree of life” based on the 16S-like rRNA genes in a majorit y of basic branchings and most lower taxa. Our phylogenetic a nalysis also shows that the chloroplast genomes are separat d into two major clades corresponding to chlorophytes s.l. and rhodophytes s.l. The interrelationships among the chloroplasts are largely in agreement with the current understan ding on chloroplast evolution.
Effect of Adding Pharmacists to Primary Care Teams on Blood Pressure Control in Patients With Type 2 Diabetes

To evaluate the effect of adding pharmacists to primary care teams on the management of hypertension and other cardiovascular risk factors in patients with type 2 diabetes.



We conducted a randomized controlled trial with blinded ascertainment of outcomes within primary care clinics in Edmonton, Canada. Pharmacists performed medication assessments and limited history and physical examinations and provided guideline-concordant recommendations to optimize medication management. Follow-up contact was completed as necessary. Control patients received usual care. The primary outcome was a ≥10% decrease in systolic blood pressure at 1 year.



A total of 260 patients were enrolled, 57% were women, the mean age was 59 years, diabetes duration was 6 years, and blood pressure was 129/74 mmHg. Forty-eight of 131 (37%) intervention patients and 30 of 129 (23%) control patients achieved the primary outcome (odds ratio 1.9 [95% CI 1.1-3.3]; P = 0.02). Among 153 patients with inadequately controlled hypertension at baseline, intervention patients (n = 82) were significantly more likely than control patients (n = 71) to achieve the primary outcome (41 [50%] vs. 20 [28%]; 2.6 [1.3-5.0]; P = 0.007) and recommended blood pressure targets (44 [54%] vs. 21 [30%]; 2.8 [1.4-5.4]; P = 0.003). The 10-year risk of cardiovascular disease, based on changes to the UK Prospective Diabetes Study Risk Engine, were predicted to decrease by 3% for intervention patients and 1% for control patients (P = 0.005).



Significantly more patients with type 2 diabetes achieved better blood pressure control when pharmacists were added to primary care teams, which suggests that pharmacists can make important contributions to the primary care of these patients.
Chronic pain acceptance questionnaire: confirmatory factor analysis, reliability, and validity in Italian subjects with chronic low back pain.

Cross-sectional evaluation of the psychometric properties of a translated questionnaire.



To validate the Italian version of the Chronic Pain Acceptance Questionnaire (CPAQ) to allow its use with Italian-speaking patients with chronic low back pain (LBP).



Growing attention is being given to cognitive-behavioral measures to improve interventions for LBP. The CPAQ has never been validated in Italian subjects with chronic LBP.



The psychometric testing included confirmatory factor analysis, reliability by internal consistency (Cronbach α), test-retest reliability (intraclass correlation coefficient), sensitivity to change by calculating the smallest detectable change, and construct validity by comparing CPAQ with a pain numerical rating scale, the Roland-Morris Disability Questionnaire Scale, the Hospital Anxiety and Depression Scale, the Pain Catastrophizing Scale, and the Tampa Scale of Kinesiophobia (Pearson correlations). Hierarchical multiple regression analyses were computed to further investigate construct validity of the CPAQ subscales.



The questionnaire was administered to 142 subjects with chronic LBP. Factor analysis confirmed a 2-factor (viz., Activities Engagement and Pain Willingness) 20-item solution, achieving a good data-model fit. Internal consistency (α = 0.88) and test-retest reliability (intraclass correlation coefficient = 0.86) were good. The smallest detectable change was 22. Construct validity showed a moderate correlation between the CPAQ and numerical rating scale (r = -0.485), Roland-Morris Disability Questionnaire Scale (r = -0.594), and Tampa Scale of Kinesiophobia (r = -0.595), and a close correlation with Hospital Anxiety and Depression Scale (r = -0.610 for the Anxiety score and r = -0.659 for the Depression score) and Pain Catastrophizing Scale (r = -0.658). The standardized regression coefficients for Activity Engagement were significant in all of the equations, and those for Pain Willingness were significant in the anxiety, depression, and disability equations.



The Italian CPAQ had a good factorial structure and psychometric properties that replicated the results of other versions. Its use is recommended for clinical and research purposes.
Antigen-specific T-cell memory is preserved in children treated for acute lymphoblastic leukemia.

Despite profound T-cell immunodeficiency, most patients treated with chemotherapy do not succumb to infection. The basis for residual protective immunity in lymphopenic patients is not known. We prospectively measured T-cell numbers, thymopoiesis, and T-cell memory in 73 children undergoing a 2-year chemotherapy regimen for acute lymphoblastic leukemia (ALL) and compared them to an age-matched cohort of 805 healthy children. Most patients had profound defects in CD4 and CD8 T-cell numbers at diagnosis that did not recover during the 2 years of therapy. Thymic output and the fraction of naive T cells were significantly lower than in healthy controls. However, the remaining T-cell compartment was enriched for antigen-experienced, memory T cells defined both by phenotype and by function. This relative sparing of T-cell memory may, in part, account for the maintenance of protective immunity in lymphopenic patients treated for ALL. Moreover, because the memory T-cell compartment is least affected by ALL and its treatment, strategies to induce immunity to pathogens or tumor antigens in cancer patients may be most successful if they seek to expand pre-existing memory T cells.
A phase I safety and pharmacokinetic study of ABT-263 in combination with carboplatin/paclitaxel in the treatment of patients with solid tumors

Bcl-2 family proteins are the key regulators of the intrinsic apoptotic pathway, controlling the point-of no-return and setting the threshold to engage the death machinery in response to chemical damage. Bcl-2 proteins have emerged as attractive targets for anti-cancer drug development. Navitoclax is a selective, potent, orally bioavailable, small molecule Bcl-2 inhibitor. Primary endpoints assessed the safety and pharmacokinetic (PK) interactions between navitoclax in combination with carboplatin/paclitaxel or paclitaxel alone in patients with solid tumors The study comprised two arms, one a combination of navitoclax with paclitaxel and carboplatin, the second with navitoclax and paclitaxel alone. Nineteen patients were enrolled in this study. The most frequently reported treatment-emergent AEs were alopecia (57.9 %), anemia (52.6 %), nausea (52.6 %), constipation (42.1 %), diarrhea (42.1 %), fatigue (42.1 %), neutropenia (36.8 %), thrombocytopenia (36.8 %), vomiting (31.6 %), decreased appetite (31.6 %), dehydration (26.3 %), and hypomagnesaemia (26.3 %). In the light of significant hematological and non-hematological toxicity the study was ended before de-escalation of navitoclax. Only one partial response was obtained at any dose tested, thus lowering doses could not have increased efficacy. It is the combination of toxicity with modest efficacy that led to discontinuation. No apparent PK interaction was observed between navitoclax and carboplatin or paclitaxel and the combination of navitoclax and paclitaxel had modest anti-tumor activity.
Methylprednisolone or naloxone treatment after acute spinal cord injury: 1-year follow-up data. Results of the second National Acute Spinal Cord Injury Study.

The 1-year follow-up data of a multicenter randomized controlled trial of methylprednisolone (30 mg/kg bolus and 5.4 mg/kg/hr for 23 hours) or naloxone (5.4 mg/kg bolus and 4.0 mg/kg/hr for 23 hours) treatment for acute spinal cord injury are reported and compared with placebo results. In patients treated with methylprednisolone within 8 hours of injury, increased recovery of neurological function was seen at 6 weeks and at 6 months and continued to be observed 1 year after injury. For motor function, this difference was statistically significant (p = 0.030), and was found in patients with total sensory and motor loss in the emergency room (p = 0.019) and in those with some preservation of motor and sensory function (p = 0.024). Naloxone-treated patients did not show significantly greater recovery. Patients treated after 8 hours of injury recovered less motor function if receiving methylprednisolone (p = 0.08) or naloxone (p = 0.10) as compared with those given placebo. Complication and mortality rates were similar in either group of treated patients as compared with the placebo group. The authors conclude that treatment with the study dose of methylprednisolone is indicated for acute spinal cord trauma, but only if it can be started within 8 hours of injury.
Mining consumer impulsivity from offline and online behavior

Consumer impulsivity is a psychological feature characterizing the impulsive buying tendency. In this paper, by bridging consumer behavior with perceived stimuli on social networks, we present a computational framework, termed Consumer Impulsivity Model (CIM), for exploring a consumer's impulsivity in both offline and online context: consumption-related location visit indicating consumption patterns in the physical realm, and online shopping behavior indicating economic activities on the Internet. To demonstrate the effectiveness of CIM, we conduct extensive experiments, with a large dataset we have collected from thousands of consumers. The results show that 1) for 103 subjects, the inferred consumer impulsivity has a positive Pearson correlation with survey results in the situation of product and product category, respectively. 2) females inferred impulsivity is higher than males on average in the situation of product and product category, respectively. Age has a negative Pearson correlation with inferred impulsivity in the situation of POI, POI category and product category, respectively. 3) for next behavior prediction, our model defeats several presented baselines. These results suggest that our framework CIM offers a powerful paradigm for 1) presenting an effective measurement for consumer impulsivity. 2) uncovering the correlation between consumer impulsivity and demographic factors and 3) revealing that the introduction of impulsivity is effective in predicting consumer behavior.