nils-herrmann/clean_scirepeval huggingface dataset:
Risperidone Versus Risperidone Plus Sodium Valproate for Treatment of Bipolar Disorders: A Randomized, Double-Blind Clinical-Trial

This study compared the efficacy of risperidone monotherapy with risperidone plus valproate in bipolar I disorder, manic phase. Some studies showed the efficacy of risperidone monotherapy in the treatment of bipolar disorder, so we examined this effectiveness in this clinical-trial study.



This 7-week, randomized, single-blind study included 48 bipolar I inpatients manic phase without psychotic features divided in risperidone group (n = 23) and risperidone plus sodium valproate group (n = 25). According to clinical symptoms, 3 categories: complete remission, partial remission and no remission were mentioned in weekly follow-up. Remission rate compared with survival analysis.



The results showed a significant difference in remission rate between risperidone monotherapy and risperidone plus sodium valproate at the 1st, 2nd and the 3rd week (p = 0.012, 0.023, 0.027 respectively), It means the remission rate in risperidone plus valproate group was higher in the first three weeks, but at the end of the seventh week, the difference was not statistically significant. There was no significant difference between the two groups in the development of adverse effects.



Risperidone can be effective and well tolerated in both acute manic episodes of bipolar mood disorders.
A randomized controlled study on the effectiveness of a multifaceted intervention program in the primary prevention of asthma in high-risk infants.

The prevalence of asthma has increased in developed countries in the past 2 decades. The effectiveness of intervention measures on the primary prevention of asthma has not been well studied.



To assess the effectiveness of a multifaceted intervention program in the primary prevention of asthma in high-risk infants (in this study, infants are defined as persons from birth to the age of 1 year).



Prospective, prenatally randomized, controlled study with follow-up through the age of 1 year.



University hospital-based settings at 2 Canadian centers: Vancouver, British Columbia, and Winnipeg, Manitoba.



A total of 545 high-risk infants (at least 1 first-degree relative with asthma or 2 first-degree relatives with other IgE-mediated allergic diseases) identified before birth.



Avoidance of house dust mite and pet allergens and environmental tobacco smoke, encouragement of breastfeeding, and supplementation with a partially hydrolyzed formula.



Probable or possible asthma, rhinitis without apparent colds, and a prick skin test result positive for common inhalant allergens.



Thirty-eight (15.1%) of the 251 infants available for assessment in the intervention group and 49 (20.2%) of the 242 infants available for assessment in the control group fulfilled the criteria for possible or probable asthma (adjusted relative risk, 0.66; 90% confidence interval, 0.44-0.98). Also, 16.7% of the infants in the intervention group and 27.3% of the infants in the control group developed rhinitis without colds (adjusted relative risk, 0.51; 90% confidence interval, 0.35-0.74). The incidence of positive skin test results to 1 or more inhalant allergens was similar in both groups (4.4% in the intervention group and 4.6% in the control group).



Our multifaceted intervention program resulted in a modest but significant (P= .04) reduction in the risk of possible or probable asthma and rhinitis without apparent colds at the age of 12 months in high-risk infants. In the absence of a validated definition of asthma at the age of 12 months, follow-up studies are needed to determine the effectiveness of the intervention program in the primary prevention of asthma in high-risk infants.
Guiding Hypertension Management Using Central Blood Pressure: Effect of Medication Withdrawal on Left Ventricular Function.

Central blood pressure (BP) is an acknowledged contributor to end-organ damage and independent determinant of prognosis. Primary analysis from the BPGUIDE study demonstrated no detriment on left ventricular (LV) structure from central BP-guided hypertension management, despite significant medication withdrawal. However, the effect of this on LV function has not been investigated. In this study, we sought to investigate the impact of central BP-guided hypertension management on LV systolic and diastolic performance.



A total of 286 enrollees with uncomplicated hypertension were randomized to therapeutic decisions guided by best-practice usual care (UC) or, in addition, by central BP intervention (CBP) for 12 months. Each participant underwent baseline and follow-up 2-dimensional echocardiography, with assessment undertaken by an expert blinded to participant allocation.



Antihypertensive medication quantity remained unchanged for UC but significantly decreased with intervention. However, no significant between-group differences were noted for changes during follow-up in both brachial and central BP, as well as other central hemodynamic parameters: augmentation index and augmented pressure. Similarly, there were no differences between groups in parameters of LV diastolic function: tissue e' velocity (∆UC vs. ∆CBP; P = 0.27) and E/e' ratio (∆UC vs. ∆CBP; P = 0.60), and systolic parameters: LV longitudinal strain (∆UC vs. ∆CBP; P = 0.55), circumferential strain (∆UC vs. ∆CBP; P = 0.79), and ejection fraction (∆UC vs. ∆CBP; P = 0.15).



Hypertension management guided by central BP, resulting in significant withdrawal of medication to maintain appropriate BP control, had no adverse effect on LV systolic or diastolic function.
Rituximab and chlorambucil as first-line treatment for low-grade ocular adnexal lymphomas

Ocular adnexal lymphomas (OALs) are typically low-grade lymphomas and are largely represented by marginal-zone lymphomas (EMZL). Radiotherapy is the treatment of choice but is frequently associated to local complications. We investigated the association of chlorambucil and rituximab as first-line treatment for primary OALs. Nine consecutive, newly diagnosed OALs patients (eight with a EMZL, one with a follicular lymphoma) with a median age of 78 years were treated with this combination. Eight patients were in stage I-A, and one was in stage IV-A; all patients had low LDH values. Eight patients (89%) obtained a complete remission and one a partial response. All completed the treatment without significant toxicities. After a median follow up of 25 months, all patients are alive; no progressions or late toxicities were observed. Rituximab in combination with chlorambucil proved to be a feasible option as first-line treatment for OALs because of its feasibility and the absence of toxicity and local sequelae.
Ambient Air Toxics and Asthma Prevalence among a Representative Sample of US Kindergarten-Age Children

Criteria pollutants have been associated with exacerbation of children's asthma, but the role of air toxics in relation to asthma is less clear. Our objective was to evaluate whether exposure to outdoor air toxics in early childhood increased asthma risk or severity.



Air toxics exposure was estimated using the 2002 National Air toxics Assessment (NATA) and linked to longitudinal data (n=6950) from a representative sample of US children born in 2001 and followed through kindergarten-age in the Early Child Longitudinal Study-Birth Cohort (ECLS-B).



Overall, 17.7% of 5.5 year-olds had ever been told by a healthcare professional they had asthma, and 6.8% had been hospitalized or visited an emergency room for an asthma attack. Higher rates of asthma were observed among boys (20.1%), low-income (24.8%), and non-Hispanic black children (30.0%) (p≤0.05). Air toxics exposure was greater for minority race/ethnicity (p<0.0001), low income (p<0.0001), non-rural area (p<0.001). Across all analyses, greater air toxics exposure, as represented by total NATA respiratory hazard index, or when limited to respiratory hazard index from onroad mobile sources or diesel PM, was not associated with a greater prevalence of asthma or hospitalizations (p trend >0.05). In adjusted logistic regression models, children exposed to the highest respiratory hazard index were not more likely to have asthma compared to those exposed to the lowest respiratory hazard index of total, onroad sources, or diesel PM.



Early childhood exposure to outdoor air toxics in a national sample has not previously been studied relative to children's asthma. Within the constraints of the study, we found no evidence that early childhood exposure to outdoor air toxics increased risk for asthma. As has been previously reported, it is evident that there are environmental justice and disparity concerns for exposure to air toxics and asthma prevalence in US children.
Cross-national comparison and validation of the Alzheimer's Disease Assessment Scale: results from the European Harmonization Project for Instruments in Dementia (EURO-HARPID).

The Alzheimer's Disease Assessment Scale (ADAS) is often used in international multicenter trials. Use across countries presupposes correct translation and adaptation of the scale, and maintenance of its psychometric properties.



To compare the various translations of the ADAS used in Western Europe, to design internationally harmonized translations and to validate these.



International cooperative study in eight European countries.



An inventory was made of existing versions of the ADAS-Cog used in eight European countries, and adaptations were made. The concurrent validity of the harmonized versions of the ADAS was tested in 283 patients with probable or possible Alzheimer's disease. The Nurses Observation Scale for Geriatrics (NOSGER), CAMCOG-R and MMSE was used to assess concordance between cognitive and behavioral measures.



Differences between the versions mainly involved object naming, items for verbal memory, such as the number of trials allowed, the imagery value of the words selected as targets or distractors, and the number of parallel versions. These differences were eliminated by adapting and harmonizing the various versions of the ADAS-Cog. Thereafter, only small differences between the different countries were found, and patterns of correlation between ADAS-Cog, and the NOSGER, CAMCOG-R and MMSE were consistent.



The study underlines the need to use harmonized versions of instruments for rating dementia in multinational studies. The findings indicate that the harmonization of the ADAS-Cog was successful.
Relationship between improvements in heart failure patient disease specific knowledge and clinical events as part of a randomized controlled trial.

To examine the changes in performance on heart failure knowledge assessments administered before and after discharge education.



We conducted a randomized controlled trial comparing the effects of a 1-h, one-on-one teaching session with a nurse educator to the standard discharge process in patients with systolic heart failure. Patients completed a 30 point heart failure knowledge questionnaire (HFKQ) prior to and 3 months after the education intervention.



Patients randomized to the nurse education intervention (n=113) demonstrated significantly higher total HFKQ score increases compared to patients receiving the standard discharge process (n=114) (median, IQR 1, 0 to 4 vs 0, -2 to 2, p=0.007). Patients experiencing death or rehospitalization in the subsequent 6 months were found to have significantly lower HFKQ scores (10, 7 to 12 vs 11, 8 to 13, p=0.002) compared to patients without a clinical event.



Heart failure nurse education at the time of hospital discharge results in improved patient knowledge and reduced risk of readmission.



Health care personnel should encourage education sessions for heart failure patients. Resources possibly need to be allocated for nurse led education sessions in heart failure patients as it improves outcomes and knowledge.
Correction: Withania somnifera Root Extract Has Potent Cytotoxic Effect against Human Malignant Melanoma Cells

In Ayurveda, Withania somnifera is commonly known as Ashwagandha, its roots are specifically used in medicinal and clinical applications. It possesses numerous therapeutic actions which include anti-inflammatory, sedative, hypnotic and narcotic. Extracts from this plant have been reported for its anticancer properties. In this study we evaluated for the first time, the cytotoxic effect of Withania root extract on human malignant melanoma A375 cells. The crude extract of Withania was tested for cytotoxicity against A375 cells by MTT assay. Cell morphology of treated A375 cells was visualized through phase contrast as well as fluorescence microscopy. Agarose gel electrophoresis was used to check DNA fragmentation of the crude extract treated cells. Crude extract of Withania root has the potency to reduce viable cell count in dose as well as time dependent manner. Morphological change of the A375 cells was also observed in treated groups in comparison to untreated or vehicle treated control. Apoptotic body and nuclear blebbing were observed in DAPI stained treated cells under fluorescence microscope. A ladder of fragmented DNA was noticed in treated cells. Thus it might be said that the crude water extract of Withania somnifera has potent cytotoxic effect on human malignant melanoma A375 cells.
Pairwise decomposition of toffoli gates in a quantum circuit

Quantum circuit synthesis is the procedure of automatically generating quantum circuits to represent specified functions. A common gate in quantum circuits is the reversible Toffoli gate, a type of generalized controlled NOT operation. There are physical barriers to implementing large quantum gates. Large Toffoli gates can be decomposed into equivalent sets of smaller, quantum elementary gates. The cost of a quantum circuit can be measured by counting the number of elementary gates in the circuit after all gates have been decomposed. Traditionally this decomposition is done independently for each gate in the circuit. This thesis identifies pairs of gates that, if decomposed together, result in fewer total elementary gates than they would otherwise. These improvements are incorporated into a simple decomposition algorithm which manipulates the circuit in order to search for such pairs. The decomposition algorithm is compared to a naive implementation, and the resulting gate costs are presented and compared.
Protection of man from natural infection with influenza A2 Hong Kong virus by amantadine: a controlled field trial.

Prophylactic administration of amantadine in doses of 100 mg. twice a day offered statistically significant protection against influenza A2 infection in a double-blind field trial involving 391 medical student volunteers during the influenza A2 Hong Kong epidemic in Helsinki in the winter of 1969. Serologically verified influenza, as measured by complement fixation and/or haemagglutination inhibition, occurred in 27 out of 192 students in the amantadine group against 57 out of 199 in the placebo group, giving a protection rate of 52%.
Single-dose and steady-state pharmacokinetics of tenofovir disoproxil fumarate in human immunodeficiency virus-infected children.

Tenofovir disoproxil fumarate (DF) is a potent nucleotide analog reverse transcriptase inhibitor approved for the treatment of human immunodeficiency virus (HIV)-infected adults. The single-dose and steady-state pharmacokinetics of tenofovir were evaluated following administration of tenofovir DF in treatment-experienced HIV-infected children requiring a change in antiretroviral therapy. Using increments of tenofovir DF 75-mg tablets, the target dose was 175 mg/m(2); the median administered dose was 208 mg/m(2). Single-dose pharmacokinetics were evaluated in 18 subjects, and the geometric mean area under the concentration-time curve from 0 h to infinity (AUC(0- infinity )) was 2,150 ng. h/ml and the geometric mean maximum concentration (C(max)) was 266 ng/ml. Subsequently, other antiretrovirals were added to each patient's regimen based upon treatment history and baseline viral resistance results. Steady-state pharmacokinetics were evaluated in 16 subjects at week 4. The steady-state, geometric mean AUC for the 24-h dosing interval was 2,920 ng. h/ml and was significantly higher than the AUC(0- infinity ) after the first dose (P = 0.0004). The geometric mean C(max) at steady state was 302 ng/ml. Tenofovir DF was generally very well tolerated. Steady-state tenofovir exposures in children receiving tenofovir DF-containing combination antiretroviral therapy approached values seen in HIV-infected adults (AUC, approximately 3,000 ng. h/ml; C(max), approximately 300 ng/ml) treated with tenofovir DF at 300 mg.
Betel quid chewing as an environmental risk factor for breast cancer.

Northeast region of India shows high incidence of tobacco-related cancer with widespread consumption of betel quid and tobacco in different forms. There is an increasing incidence of breast cancer and eminent use of tobacco in females in this region. Thus, we analysed the role of tobacco exposure and polymorphisms in detoxification enzymes in breast cancer risk. Polymorphisms in five gene variants (GSTT1, GSTM1, GSTP1, TP53 and CYP17) and four environmental exposure variables (tobacco smoking, tobacco chewing, betel quid chewing, alcohol) were analysed in 117 breast cancer cases and 174 cancer free controls. Multifactor dimensionality reduction identified betel quid chewing as the single main risk factor and women with betel quid chewing history had five times the risk of developing breast cancer [4.78 (2.87-8.00) 0.001]. In logistic regression analysis, GSTT1 null and GSTM1 null genotypes conferred 41% less [0.59 (0.34-1.03) 0.06] and 55% less [0.58 (0.30-1.02) 0.05] reduced risk to breast cancer, respectively. However, the risk increased in women with GSTP1 variant G allele which conferred 1.43 times [(0.96-2.11) 0.07] more risk to breast cancer. In conclusion this study suggests betel quid chewing as a significant risk factor for developing breast cancer. Moreover, the lack of detoxification enzymes GSTT1 and GSTM1 are associated with reduced breast cancer risk.
Phase II multicentre trial of oral quisinostat, a histone deacetylase inhibitor, in patients with previously treated stage IB-IVA mycosis fungoides/Sézary syndrome.

Quisinostat is a hydroxamate, second-generation, orally available pan-histone deacetylase inhibitor.



To evaluate the efficacy and safety of oral quisinostat in patients with previously treated cutaneous T-cell lymphoma (CTCL).



Patients received quisinostat 8 mg or 12 mg on days 1, 3 and 5 of each week in 21-day treatment cycles. Primary efficacy end point was cutaneous response rate (RR) based on the modified Severity Weighted Assessment Tool (mSWAT). Secondary end points included global RR, duration of response (DOR) in skin, progression-free survival (PFS), pruritus relief, safety and pharmacodynamic markers.



Eight of 26 (25 evaluable) patients achieved ≥ 50% reduction in mSWAT score at least once, with confirmed cutaneous response in six (RR 24%). There was a low global RR of 8%. DOR in skin ranged from 2·8 to 6·9 months. Median PFS was 5·1 months. Pruritus relief was more frequent in cutaneous responders (67%) than nonresponders (32%). Serial tumour biopsies revealed an increase in acetylated tubulin, indicating a target effect of histone deacetylase 6. Twenty-one of 26 (81%) patients were withdrawn from the study before or at clinical cut-off; five (19%) continued to receive treatment with quisinostat. The most common drug-related adverse events were nausea, diarrhoea, asthenia, hypertension, thrombocytopenia and vomiting. Grade 3 drug-related adverse events included hypertension, lethargy, pruritus, chills, hyperkalaemia and pyrexia.



Quisinostat 12 mg three times weekly is active in the treatment of patients with relapsed or refractory CTCL, with an acceptable safety profile. Combination therapy with other drugs active in CTCL may be appropriate.
Validation of the Tensoval Duo Control II blood pressure monitor for clinic use and self-measurement according to the British Hypertension Society protocol and the European Society of Hypertension International Protocol Revision 2010.

The Tensoval Duo Control II is an automated upper arm device that uses a combination of oscillometric and auscultatory technology to determine blood pressure noninvasively. The accuracy of this device was assessed according to the British Hypertension Society (BHS) protocol and the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) in an adult population.



Ethical approval was obtained. Eighty-five and 33 adult individuals, respectively, were recruited to fulfil the requirements of each protocol. Trained observers took nine sequential same-arm measurements alternating between a mercury sphygmomanometer and the device. The device had to achieve at least a B grade for both systolic and diastolic pressures to pass the BHS protocol and had to fulfil the criteria of all three phases of the ESH-IP2 protocol to receive recommendation.



The device achieved an A/A grading for the BHS protocol and passed all three phases of the ESH-IP2 protocol. The mean difference±SD for the BHS/ESH protocols, respectively, was -1.8±6.5/-0.7±5.7 mmHg for systolic pressure and 1.9±5.1/2.4±4.5 mmHg for diastolic pressure. The device maintained its A/A grading throughout the low-pressure, medium-pressure and high-pressure ranges.



The Tensoval Duo Control II device is recommended for clinical and home use according to both the BHS and the ESH-IP2 standard.
Spironolactone Reduces Severity of Obstructive Sleep Apnea in Patients with Resistant Hypertension: a Preliminary Report

Obstructive sleep apnoea (OSA) and hyperaldosteronism are very common in subjects with resistant hypertension. We hypothesized that aldosterone-mediated chronic fluid retention may influence OSA severity in patients with resistant hypertension. We tested this in an open-label evaluation by assessing the changes in the severity of OSA in patients with resistant hypertension after treatment with spironolactone. Subjects with resistant hypertension (clinical blood pressure (BP) ⩾140/90 mm Hg on ⩾3 antihypertensive medications, including a thiazide diuretic and OSA (defined as an apnoea–hypopnoea index (AHI) ⩾15) had full diagnostic, polysomnography before and 8 weeks after spironolactone (25–50 mg a day) was added to their ongoing antihypertensive therapy. In all, 12 patients (mean age 56 years and body mass index 36.8 kg m–2) were evaluated. After treatment with spironolactone, the AHI (39.8±19.5 vs 22.0±6.8 events/h; P<0.05) and hypoxic index (13.6±10.8 vs 6.7±6.6 events/h; P<0.05), weight and clinic and ambulatory BP were significantly reduced. Plasma renin activity (PRA) and serum creatinine were significantly higher. This study provides preliminary evidence that treatment with a mineralocorticoid receptor antagonist substantially reduces the severity of OSA. If confirmed in a randomized assessment, it will support aldosterone-mediated chronic fluid retention as an important mediator of OSA severity in patients with resistant hypertension.