nils-herrmann/clean_scirepeval huggingface dataset:
Phenobarbitone versus phenytoin for treatment of neonatal seizures: an open-label randomized controlled trial.

To compare the efficacy of phenobarbitone and phenytoin for treatment of neonatal seizures in term and near-term neonates.



Open labeled randomized controlled trial.



Neonatal intensive care unit of a level II unit from India, from November 2008 to September 2009.



All term and late pre-term neonates admitted with clinically apparent seizures and not having any transient metabolic disorders (hypoglycemia or hypocalcemia) were randomly assigned.



Phenobarbitone (n=54) or phenytoin (n=55) intravenously 20 mg/kg/dose over 20-30 min. Neonates whose seizures were not controlled by the assigned drug were then crossed over to be treated with other drug in same dose.



Clinical control of seizures (seizure free period of 24 hours after giving anticonvulsant).



Baseline characteristics including mean birthweight, gestation age and sex were comparable in both groups. Seizures were controlled in 8 of the 55 (14.5%) neonates who received phenytoin, as compared to 39 of 54 (72.2%) neonates who received phenobarbitone (P <0.001). In babies not responding to assigned drugs, after cross-over to the other drug, seizure control was achieved in 44/55 (80%) of the neonates assigned to receive phenytoin first as compared to 49/54 (91%) of those assigned to receive phenobarbitone first (P=0.014). After maximum dose of phenobarbitone seizures were controlled in 49/55(89%) in phenytoin group and 52/54 (96%) in phenobarbitone group (P<0.05).



Phenobarbitone is more efficacious than phenytoin in control of clinical seizures in term or near-term neonates, irrespective of etiology. To evaluate serum vascular endothelial growth factor (VEGF) levels in children with acute lymphoblastic leukemia (ALL) during the induction phase of chemotherapy.
Mechanistic Pathways of Mindfulness Meditation in Combat Veterans With Posttraumatic Stress Disorder.

This study's objective was to evaluate the effect of two common components of meditation (mindfulness and slow breathing) on potential mechanistic pathways.



A total of 102 combat veterans with posttraumatic stress disorder (PTSD) were randomized to (a) the body scan mindfulness meditation (MM), (b) slow breathing (SB) with a biofeedback device, (c) mindful awareness of the breath with an intention to slow the breath (MM+SB), or (d) sitting quietly (SQ). Participants had 6 weekly one-on-one sessions with 20 minutes of daily home practice. The mechanistic pathways and measures were as follows: (a) autonomic nervous system (hyperarousal symptoms, heart rate [HR], and heart rate variability [HRV]); (b) frontal cortex activity (attentional network task [ANT] conflict effect and event-related negativity and intrusive thoughts); and (c) hypothalamic-pituitary-adrenal axis (awakening cortisol). PTSD measures were also evaluated.



Meditation participants had significant but modest within-group improvement in PTSD and related symptoms, although there were no effects between groups. Perceived impression of PTSD symptom improvement was greater in the meditation arms compared with controls. Resting respiration decreased in the meditation arms compared with SQ. For the mechanistic pathways, (a) subjective hyperarousal symptoms improved within-group (but not between groups) for MM, MM+SB, and SQ, while HR and HRV did not; (b) intrusive thoughts decreased in MM compared with MM+SB and SB, while the ANT measures did not change; and (c) MM had lower awakening cortisol within-group (but not between groups).



Treatment effects were mostly specific to self-report rather than physiological measures. Continued research is needed to further evaluate mindfulness meditation's mechanism in people with PTSD.
Improving the quality of life of multiple sclerosis patients through coping strategies in routine medical practice

Multiple sclerosis (MS) has a major impact on quality of life (QoL). Coping strategies which may influence QoL have not been identified. Furthermore, there is no coping scale designed to measure coping in MS patients and concise enough for routine medical practice. We used 46 items and 7 coping dimensions; we successively reduced the minimum number of dimensions through confirmatory factor analysis (CFA) and Rasch modelling. The resulting scale was submitted to psychometric validation via an independent cross-sectional analysis. After administration to 331 MS patients, we eliminated 10 of the 46 initial items; a CFA iterative algorithm identified a positive coping (PC) group and a negative coping (NC) group; an iterative reduction algorithm led to a final 10 items questionnaire, which was tested in an independent, new cross-sectional sample of 457 patients. Psychometric tests, including the Rasch model and CFA, successfully validated the scale, confirming the two dimensions and the absence of differential item functioning. The correlation between coping and QoL increased to 0.59 and 0.62 for NC and PC, respectively, compared with 0.33 found with existing scales. Our findings justify a one-dimensional overall coping scale (PC + NC). The effect of coping on QoL can be evaluated simply by adding together a positive and a negative coping strategy, for which we developed a short 10-item scale, which can be considered as an effective means of measuring the impact of coping on QoL and is ideal in routine medical practice.
Cost-effectiveness of nurse-led versus doctor-led antiretroviral treatment in South Africa: pragmatic cluster randomised trial.

To estimate the cost-effectiveness of nurse-led versus doctor-led antiretroviral treatment (ART) for HIV-infected people.



Cost-effectiveness analysis alongside a pragmatic cluster randomised controlled trial in 31 primary care clinics (16 intervention, 15 controls) in Free State Province, South Africa. Participants were HIV-infected patients, aged ≥16 years. Cohort 1 (CD4 count ≤350 cells/μl, not yet receiving ART at enrolment): consisted of 5 390 intervention patients and 3 862 controls; Cohort 2 (already received ART for ≥6 months at enrolment) of 3 029 intervention patients and 3 202 controls. Nurses were authorised and trained to initiate and represcribe ART. Management and ART provision were decentralised to primary care clinics. In control clinics, doctors initiated and re-prescribed ART, nurses monitored ART. Main outcome measure(s) were health service costs, death (cohort 1) and undetectable viral load (<400 copies/ml) (cohort 2) during the 12 months after enrolment.



For Cohort 1, the intervention had an estimated incremental cost of US$102.52, an incremental effect of 0.42% fewer deaths and an incremental cost-effectiveness ratio (ICER) of US$24 500 per death averted. For Cohort 2, the intervention had an estimated incremental cost of US$59.48, an incremental effect of 0.47% more undetectable viral loads and an ICER of US$12 584 per undetectable viral load.



Nurse-led ART was associated with higher mean health service costs than doctor-led care, with small effects on primary outcomes, and a high associated level of uncertainty. Given this, and the shortage of doctors, further implementation of nurse-led ART should be considered, although this may increase health service costs.
Effects of losartan titrated to losartan/hydrochlorothiazide and amlodipine on blood pressure and peripheral capillary microcirculation in patients with mild-to-moderate hypertension

To measure the effects of losartan and amlodipine on peripheral capillary microcirculation in hypertension. Medical out-patient clinic, Basel, in a university teaching hospital. After a 4-week placebo run-in period 20 patients aged 50 ± 8 (range 36–65) years with mild-to-moderate hypertension were randomly allocated to receive active treatment with losartan 50 mg titrated to losartan 50 mg/hydrochlorothiazide (HCT) 12.5 mg, or amlodipine 5 mg titrated to 10 mg for a 12 week period. Titration was performed if diastolic blood pressure (BP) was ⩾90 mm Hg after 6 weeks of treatment. BP measurements as well as video capillary microscopy of the finger nailfold at the end of the placebo period and after 12 weeks of active treatment were compared. Capillary blood cell velocity was measured at rest and immediately, 1 min and 2 min after local finger cooling. After 3 months of treatment with amlodipine (n = 10) and losartan titrated to losartan-HCT (n = 10) sitting BP decreased significantly from 160 ± 7/103 ± 4 mm Hg and 147 ± 7/98 ± 6 mm Hg to 131 ± 10/86 ± 7 mm Hg and 134 ± 17/89 ± 9 mm Hg, respectively (P < 0.01). after local finger cooling the area under the curve (auc) of capillary blood cell velocities was 1.13 ± 0.58 mm (median ± s.d.) at baseline and increased to 1.94 ± 1.15 (P < 0.05) in losartan/losartan-hct treated patients. in amlodipine treated patients the increase in auc of capillary blood cell velocity did not reach the level of statistical significance (1.59 ± 1.36 to 2.14 ± 1.05 mm).Conclusion: This small trial shows that the area under the curve of capillary blood cell velocity increases in hypertensive patients treated with both losartan/ losartan-HCT and amlodipine compared with baseline values.
A randomized controlled non-inferiority study comparing the antiemetic effect between intravenous granisetron and oral azasetron based on estimated 5-HT3 receptor occupancy.

The acute antiemetic effect was compared between oral azasetron and intravenous granisetron based on the 5-hydroxytryptamine(3) (5-HT(3)) receptor occupancy theory.



Receptor occupancy was estimated from reported data on plasma concentrations and affinity constants to 5-HT(3) receptor. A randomized non-inferiority study comparing acute antiemetic effects between oral azasetron and intravenous granisetron was performed in 105 patients receiving the first course of carboplatin-based chemotherapy for lung cancer.



Azasetron exhibited the highest 5-HT(3) receptor occupancy among various first-generation 5-HT(3) antagonists. The complete response to oral azasetron was shown to be non-inferior to that of intravenous granisetron, in which the risk difference was 0.0004 (95% confidence interval: -0.0519-0.0527). The lower limit of the confidence intervals did not exceed the negative non-inferiority margin (-0.1). The complete response during the overall period was not different (68% versus 67%).



Oral azasetron was found to be non-inferior to intravenous granisetron in the acute antiemetic effect against moderately emetogenic chemotherapy.
The addition of upper cervical manipulative therapy in the treatment of patients with fibromyalgia: a randomized controlled trial

The aim of this study was to investigate the immediate and long-term effects of a one-year multimodal program, with the addition of upper cervical manipulative therapy, on fibromyalgia management outcomes in addition to three-dimensional (3D) postural measures. This randomized clinical trial with one-year follow-up was completed at the research laboratory of our university. A total of 120 (52 female) patients with fibromyalgia syndrome (FMS) and definite C1-2 joint dysfunction were randomly assigned to the control or an experimental group. Both groups received a multimodal program; additionally, the experimental group received upper cervical manipulative therapy. Primary outcomes were the Fibromyalgia Impact Questionnaire (FIQ), whereas secondary outcomes included Pain Catastrophizing Scale (PCS), algometric score, Pittsburgh Sleep Quality Index (PSQI), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), and 3D postural measures. Measures were assessed at three time intervals: baseline, 12 weeks, and 1 year after the 12-week follow-up. The general linear model with repeated measures indicated a significant group × time effect in favor of the experimental group on the measures of 3D postural parameters (P < .0005), FIQ (P < .0005), PCS (P < .0005), algometric score (F = P < .0005), PSQI (P < .0005), BAI (P < .0005), and BDI (P < .0005). The addition of the upper cervical manipulative therapy to a multimodal program is beneficial in treating patients with FMS.
Randomized clinical trial of the effect of perioperative synbiotics versus no synbiotics on bacterial translocation after oesophagectomy.

The impact of perioperative synbiotics on bacterial translocation and subsequent bacteraemia after oesophagectomy is unclear. This study investigated the effect of perioperative synbiotic administration on the incidence of bacterial translocation to mesenteric lymph nodes (MLNs) and the occurrence of postoperative bacteraemia.



Patients with oesophageal cancer were randomized to receive perioperative synbiotics or no synbiotics (control group). MLNs were harvested from the jejunal mesentery before dissection (MLN-1) and after the restoration of digestive tract continuity (MLN-2). Blood and faeces samples were taken before and after operation. Microorganisms in each sample were detected using a bacterium-specific ribosomal RNA-targeted reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) method.



Some 42 patients were included. There was a significant difference between the two groups in detection levels of microorganisms in the MLN-1 samples. Microorganisms were more frequently detected in MLN-2 samples in the control group than in the synbiotics group (10 of 18 versus 3 of 18; P = 0·035). In addition, bacteraemia detected using RT-qPCR 1 day after surgery was more prevalent in the control group than in the synbiotics group (12 of 21 versus 4 of 21; P = 0·025). Neutrophil counts on postoperative days 1, 2 and 7 after surgery were all significantly higher in the control group than in the synbiotics group.



Perioperative use of synbiotics reduces the incidence of bacteria in the MLNs and blood. These beneficial effects probably contribute to a reduction in the inflammatory response after oesophagectomy.
Effect of asthma management education program on stress and compliance of patients with allergic asthma to house dust mite.

This study was designed to examine the effect of asthma management education program applied to allergic asthma patients receiving immunotherapy due to house dust mite on their stress and compliance with health care regimens.



A quasi experimental design with non-equivalent control group and non-synchronized design was used. The subjects of this study were 61 patients who were receiving immunotherapy at intervals of a week after their symptoms were diagnosed as house dust mite allergic asthma at the pulmonary department of a university hospital in Seoul. They were divided into an experimental group of 29 patients who received asthma management education and a control group of 32 patients. The asthma management education program was composed of group education (once) and reinforcement education (three times) with environmental therapy and immunotherapy to house dust mite.



Stress significantly decreased in the experimental group compared to that in the control group. Compliance with health care regimens significantly increased in the experimental group compared to that in the control group.



The results suggested that the asthma management education program is effective for the management of stress and the improvement of compliance in patients with allergic asthma to house dust mite.
Recovery after total hip joint arthroplasty in elderly patients with osteoarthritis: positive effect of upper limb interval-training.

To evaluate the influence of an interval training program for the upper limbs on cardiorespiratory fitness and walking ability in elderly patients after total hip joint arthroplasty.



A randomized controlled trial. After surgery, control and training groups started general rehabilitation. Training group combined it with an arm-interval exercise program (3 sessions of 30 minutes per week, for 6 weeks).



Patients were assigned randomly to control (n = 7) and training groups (n = 7).



Incremental exercise tests were carried out until exhaustion on an arm crank ergometer 1 month before and 2 months after surgery. A 6-minute walk test was also performed 2 months after surgery.



VO2 peak increased significantly in the training group (p = 0.0424) and did not change in the control group. The difference in VO2 peak change between the groups was significant (p = 0.0362, +19.2% in the training group and -3.5% in the control group). In the walking test the training group covered a significantly longer distance than did the control group (p = 0.0055, 396.4 metres and 268.1 metres, respectively).



These results stress the importance of physical training in a rehabilitation program after total hip joint arthroplasty and this should be considered for improving the current practices in rehabilitation.
Group therapy for women with substance use disorders: results from the Women's Recovery Group Study.

This Stage II trial builds on a Stage I trial comparing the single-gender Women's Recovery Group (WRG) to mixed-gender Group Drug Counseling (GDC) that demonstrated preliminary support for the WRG in treating women with substance use disorders. The Stage II trial aims were to (1) investigate effectiveness of the WRG relative to GDC in a sample of women heterogeneous with respect to substance of abuse and co-occurring psychiatric disorders, and (2) demonstrate the feasibility of implementing WRG in an open-enrollment group format at two sites.



In this randomized clinical trial, participants were included if they were substance dependent and had used substances within the past 60 days (n=158). Women were randomized to WRG (n=52) or GDC (n=48); men were assigned to GDC (n=58). Substance use outcomes were assessed at months 1-6 and 9.



Women in both the WRG and GDC had reductions in mean number of substance use days during treatment (12.7 vs 13.7 day reductions for WRG and GDC, respectively) and 6 months post-treatment (10.3 vs 12.7 day reductions); however, there were no significant differences between groups.



The WRG demonstrated comparable effectiveness to standard mixed-gender treatment (i.e., GDC) and is feasibly delivered in an open-group format typical of community treatment. It provides a manual-based group therapy with women-focused content that can be implemented in a variety of clinical settings for women who are heterogeneous with respect to their substance of abuse, other co-occurring psychiatric disorders, and life-stage.
Prognostic impact of blast cell counts in dysplastic bone marrow disorders (MDS and CMML I) with concomitant fibrosis

In a retrospective study, 43 patients with dysplastic neoplasms of the bone marrow (myelodysplastic syndromes and myelodysplastic/myeloproliferative-overlap neoplasms) associated with marked (grades 2–3) fibrosis were examined. Histopathologic and morphologic findings as well as cytogenetic and molecular results were correlated with clinical endpoints. Multilineage dysplasia (34 of 43 patients, 79 %) and hypercellular bone marrow (64 %) were found in most patients. In ten of 35 patients, poor risk karyotypes according to the International Prognostic Scoring System (IPSS) were recorded. The JAK2 V617F mutation was detected in four of 30 patients (13 %), and the KIT D816V mutation was found in two of 30 patients (6 %). Patients were mainly treated with palliative drugs and best supportive care. After an observation time of 1–41 (median 21) months, ten of 43 patients (23 %) had developed a secondary acute leukemia. The median survival of all 43 patients was 21.4 months (range 1.8–88.2 months). Of all prognostic parameters examined, the blast cell count at diagnosis was found to be a most reliable and most predictive marker concerning survival and leukemia progression. This confirms previous studies in dysplastic bone marrow neoplasms without fibrosis.
The effect of vitamin E on the treatment of menstrual migraine.

Many women with migraine experience a change in migraine frequency associated with the menstrual cycle. This study was undertaken to study the effect of vitamin E as a prophylactic agent on women with menstrual migraine.



During a placebo-controlled double-blinded trial, 72 women with menstrual migraine received placebo (identical in appearance to vitamin E) daily for five days, two days before to three days after menstruation for two cycles followed by a one-month wash-out and one vitamin E softgel (400 IU) daily for five days in the next two cycles. Each woman was evaluated monthly throughout the study and the daily headache severity, concomitant symptoms, and functional disability derived from questionnaires were compared between the vitamin E and the placebo treatment periods using four-point anchored scales.



There were statistically significant differences in the pain severity and functional disability scales between the placebo and the vitamin E treatments (p<0.001). Vitamin E effect was also superior to placebo regarding photophobia, phonophobia, and nausea (p<0.05).



Vitamin E is effective in relieving symptoms due to menstrual migraine.
Metformin in early breast cancer: a prospective window of opportunity neoadjuvant study

Metformin may exert anti-cancer effects through indirect (insulin-mediated) or direct (insulin-independent) mechanisms. We report results of a neoadjuvant “window of opportunity” study of metformin in women with operable breast cancer. Newly diagnosed, untreated, non-diabetic breast cancer patients received metformin 500 mg tid after diagnostic core biopsy until definitive surgery. Clinical (weight, symptoms, and quality of life) and blood [fasting serum insulin, glucose, homeostasis model assessment (HOMA), C-reactive protein (CRP), and leptin] attributes were compared pre- and post-metformin as were terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL) and Ki67 scores (our primary endpoint) in tumor tissue. Thirty-nine patients completed the study. Mean age was 51 years, and metformin was administered for a median of 18 days (range 13–40) up to the evening prior to surgery. 51 % had T1 cancers, 38 % had positive nodes, 85 % had ER and/or PgR positive tumors, and 13 % had HER2 overexpressing or amplified tumors. Mild, self-limiting nausea, diarrhea, anorexia, and abdominal bloating were present in 50, 50, 41, and 32 % of patients, respectively, but no significant decreases were seen on the EORTC30-QLQ function scales. Body mass index (BMI) (−0.5 kg/m2, p < 0.0001), weight (−1.2 kg, p < 0.0001), and HOMA (−0.21, p = 0.047) decreased significantly while non-significant decreases were seen in insulin (−4.7 pmol/L, p = 0.07), leptin (−1.3 ng/mL, p = 0.15) and CRP (−0.2 mg/L, p = 0.35). Ki67 staining in invasive tumor tissue decreased (from 36.5 to 33.5 %, p = 0.016) and TUNEL staining increased (from 0.56 to 1.05, p = 0.004). Short-term preoperative metformin was well tolerated and resulted in clinical and cellular changes consistent with beneficial anti-cancer effects; evaluation of the clinical relevance of these findings in adequately powered clinical trials using clinical endpoints such as survival is needed.