nils-herrmann/clean_scirepeval huggingface dataset:
Effectiveness of olanzapine, quetiapine, risperidone, and ziprasidone in patients with chronic schizophrenia following discontinuation of a previous atypical antipsychotic.

In the treatment of schizophrenia, changing antipsychotics is common when one treatment is suboptimally effective, but the relative effectiveness of drugs used in this strategy is unknown. This randomized, double-blind study compared olanzapine, quetiapine, risperidone, and ziprasidone in patients who had just discontinued a different atypical antipsychotic.



Subjects with schizophrenia (N=444) who had discontinued the atypical antipsychotic randomly assigned during phase 1 of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) investigation were randomly reassigned to double-blind treatment with a different antipsychotic (olanzapine, 7.5-30 mg/day [N=66]; quetiapine, 200-800 mg/day [N=63]; risperidone, 1.5-6.0 mg/day [N=69]; or ziprasidone, 40-160 mg/day [N=135]). The primary aim was to determine if there were differences between these four treatments in effectiveness measured by time until discontinuation for any reason.



The time to treatment discontinuation was longer for patients treated with risperidone (median: 7.0 months) and olanzapine (6.3 months) than with quetiapine (4.0 months) and ziprasidone (2.8 months). Among patients who discontinued their previous antipsychotic because of inefficacy (N=184), olanzapine was more effective than quetiapine and ziprasidone, and risperidone was more effective than quetiapine. There were no significant differences between antipsychotics among those who discontinued their previous treatment because of intolerability (N=168).



Among this group of patients with chronic schizophrenia who had just discontinued treatment with an atypical antipsychotic, risperidone and olanzapine were more effective than quetiapine and ziprasidone as reflected by longer time until discontinuation for any reason.
Increased Arterial Distensibility in Postmenopausal Hypertensive Women with and Without Hormone Replacement Therapy after Acute Administration of the Ace Inhibitor Moexipril

Menopause and essential hypertension are associated with a decreased compliance and distensibility of the arteries. ACE inhibitors have been shown to improve arterial distensibility. Hormone replacement therapy (HRT), especially estrogens, could have a positive influence through their atheroprotective, vasodilative, and blood pressure–lowering effect. The vascular interactions of HRT and ACE inhibitors, like moexipril hydrochloride, have not been investigated so far. This trial was intended to assess the effect of combined sequential HRT for 25 days on acute changes in arterial distensibility after a single oral dose of 15 mg moexipril hydrochloride in postmenopausal women with borderline to mild essential hypertension. This study had a monocentric, randomized, parallel-group design, and was open for moexipril, and double-blind, and placebo-controlled for HRT. Assessment of arterial distensibility was by automatic noninvasive measurement of the carotid–femoral pulse wave velocity (PWV). The PWV and the pulse pressure decreased significantly after a single oral dose of 15 mg moexipril. An influence of HRT on the changes in the PWV and pulse pressure could not be seen. The plasma concentrations of renin increased and of aldosterone decreased after moexipril administration. Arterial function improves after acute administration of 15 mg moexipril in postmenopausal women with mild to moderate essential hypertension. The changes in PWV and pulse pressure are of similar magnitude in women with and without HRT.
A genomewide association study of response to lithium for prevention of recurrence in bipolar disorder.

Lithium remains a first-line treatment for bipolar disorder, but the mechanisms by which it prevents the recurrence of mood episodes are not known. The authors utilized data from a genomewide association study to examine associations between single nucleotide polymorphisms (SNPs) and the outcome of lithium treatment in two cohorts of patients with bipolar I disorder or bipolar II disorder.



The hazard for mood episode recurrence was examined among 1,177 patients with bipolar I disorder or bipolar II disorder, including 458 individuals treated with lithium carbonate or citrate, who were participants in the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) cohort. SNPs showing the greatest evidence of association in Cox regression models were then examined for association with positive lithium response among 359 bipolar I or II disorder patients treated with lithium carbonate or citrate in a second cohort from the University College London.



The strongest association in the STEP-BD cohort (minimum p=5.5 x 10(-7)) was identified for a region on chromosome 10p15 (rs10795189). Of the regions showing suggestive evidence (p<5 x 10(-4)) of association with lithium response, five were further associated with positive lithium response in the University College London cohort, including SNPs in a region on chromosome 4q32 spanning a gene coding for the glutamate/alpha-amino-3-hydroxy-5-methyl-4-isoxazolpropionate (AMPA) receptor GRIA2.



Multiple novel loci merit further examination for association with lithium response in bipolar disorder patients, including one region that spans the GRIA2 gene, for which expression has been shown to be regulated by lithium treatment.
An anti-idiotype vaccine elicits a specific response to N-glycolyl sialic acid residues of glycoconjugates in melanoma patients.

We generated the 1E10 gamma-type anti-idiotype mAb (Ab2) specific to an Ab1 mAb able to react specifically with N-glycolyl-containing gangliosides and with Ags expressed on human melanoma and breast carcinoma cells. This Ab2 mAb induced an Ab response in animal models sharing immunochemically defined idiotopes with the Ab1. The treatment of tumor-bearing mice with 1E10 mAb induced a strong antitumor activity. A clinical trial was conducted in 20 patients with advanced malignant melanoma. Patients were treated with six intradermal injections of aluminum hydroxide-precipitated 1E10 anti-Id mAb given at 2-wk intervals. Sixteen of the 17 patients who received at least four doses of the anti-Id vaccine develop Ab3 Abs capable of inhibiting Ab2 binding to Ab1 (Ab3Id+). In contrast to the incapacity of 1E10 mAb to generate Ab3 Abs with the same antigenic specificity as the Ab1 mAb in mice, a very specific and strong Ab3 response against N-glycolyl-containing gangliosides was induced in 16 patients (Ab3Ag+). No evidence of serious or unexpected adverse effects has been observed in this clinical trial. 1E10 anti-Id vaccine was safe, well tolerated, and immunologically effective, with most patients being able to generate a specific immune response against 1E10 and Neu-glycolyl-GM(3) ganglioside.
Development of the Fogg Intent-to-Screen for HIV (ITS HIV) questionnaire.

In this paper, we describe the development and psychometric properties of the Fogg Intent-to-Screen for HIV questionnaire (ITS HIV), which measures peoples' beliefs and intentions toward HIV screening. The ITS HIV was developed using the Theory of Planned Behavior as the framework for a developmental process that included qualitative interviews, a validation phase, two pilot tests, and a field test of the final 55-item questionnaire. The field test involved 312 homeless persons from five New England states. Cronbach alphas of the direct measures scales ranged from .72 to .90. Findings from a path analysis verified the construct validity. The psychometric estimates from these analyses suggest the ITS HIV questionnaire is appropriate for use in clinical practice or to evaluate the effectiveness of interventions.
Additional beneficial effects of recombinant growth hormone in alendronate-treated patients with idiopathic osteoporosis.

In order to study the benefit of adding recombinant human growth hormone (rhGH) to antiresorptive therapy, six patients with idiopathic osteoporosis (IO) receiving alendronate plus calcium and vitamin D were started on daily subcutaneous injections of rhGH 2.0 IU for one year. Fasting morning urine and serum samples were collected for N telopeptide of type-1 collagen (NTX), serum bone-specific alkaline phosphatase (BSAP) and insulin-like growth factor 1 (IGF-1) during the study. Bone mineral density (BMD) was determined by dual-energy x-ray absorptiometry at baseline and 01 year. The effect of rhGH was evaluated comparing the percentage changes in BMD during the last year on ALN with the results obtained with the combined therapy. Serum IGF-1 increased in all patients but variations were not significant (p=0.266). Serum BSAP did not significantly change (p=0.078) but median NTX increased at 45 days from 12.3 to 19.8 nMBCE/mMCr (p=0.012) and tended to return to baseline values at 12 months (15.2 nMBCE/mMCr). Comparing with isolated ALN therapy, a beneficial effect on bone density was observed in 2/3 of the patients at lumbar spine, and percentage change (median and quartiles) varied from -0.65% (-2.33 and 2.23) on ALN to 0.70% (-0.35 and 3.03) on ALN+GH. Although no bone gain occurred at the femoral neck, our data point to a positive effect of rhGH in patients with idiopathic osteoporosis.
Anterior lesser curve seromyotomy with posterior truncal vagotomy versus proximal gastric vagotomy: Results of a prospective randomized trial 3–8 years after surgery

In a prospective randomized trial, anterior lesser curve seromytomy with posterior truncal vagotomy (ASPTV, n=50) was compared with proximal gastric vagotomy (PGV, n=50). Most of our patients were young men with ASA grade I risk, and 80% were expatriates. They were followed up for 3 to 8 years after surgery. The mean reductions of basal acid output (BAO) and insulin-stimulated peak acid output (IPAO) were 85% and 88%, respectively, soon after surgery for both ASPTV and PGV groups. These values remained at 70% and 60% of their preoperative level for 1 year. Good to excellent results (Visick I and II) were recorded in 76% of cases in both groups. The recurrent ulcer rate was 14% for PGV and 12% for ASPTV. This trial suggests that for the treatment of duodenal ulcer ASPTV is as good an operation as PGV. Dans une étude prospective randomisée, on a comparé la séromyotomie antérieure avec vagotomie tronculaire postérieure (SM) (n=50) avec la vagotomie proximale (VP) (n=50) pour traiter l'ulcère duodénal La plupart des patients étaient des hommes, jeunes, de classe ASA 1 et 80% étaient des expatriés. Le suivi a été compris entre 3 et 8 ans. La réduction moyenne de la sécrétion acide basale (BAO) et de la sécrétion maximale stimulée par l'insuline (IPAO) ont été respectivement de 85% et de 88% après la chirurgie pour la SM et la VP. A un an, ces taux etaient respectivement de 70% et 60%. Des résultats jugés bons à excellents (Visick I et II) ont été enregistrés dans 76% des cas dans les deux groupes. Le taux de récidive a été de 14% pour la VG et de 12% pour la SM. Les résultats de cet essai suggèrent que la SM est aussi efficaces que la VG dans le traitement de l'ulcère duodénal. En un estudio prospectivo y randomizado se comparó el procedimiento de seromiotomía anterior + vagotomía troncal posterior (SMAVT, n=50) con la vagotomía gástrica proximal (VGP, n=50). La mayor parte de nuestros pacientes eran hombres jóvenes de riesgo grado I de la clasificación de la ASA y 80% eran expatriados. El seguimiento fue de 3–8 ańos después de la cirugía. La reducción promedio de la secreción basal de ácido (SBA) y el pico de la secreción de ácido estimulada por insulina fueron 85% y 88%, al poco tiempo de la cirugía, para la SMAVT y la VGP respectivamente; al cabo de un ańo se ha mantenido tal situación a niveles de 70% y 60% con respecto a los valores preoperatorios. Se registraron resultados buenos a excelentes (Visick I y II) en 76% de los casos en ambos grupos. Las tasas de recidiva de la ulcera fueron 14% para la SMVAT y 12% para la VGP. El presente ensayo sugiere que, en la experiencia de los autores, la SMVAT es una operación tan buena como la VGP en el tratamiento de la úlcera duodenal.
Five-Month Observation of Persistent Diabetic Macular Edema after Intravitreal Injection of Ozurdex Implant

This retrospective analysis was aimed at evaluating the effectiveness of treatment of persistent diabetic macular edema with intravitreal injections of 0.7 mg dexamethasone implant Ozurdex. The study comprised three male patients (6 eyes).



The average thickness of the retina at baseline was 632  μm, the medial BCVA was 0.8 logMAR, and corrected intraocular pressure was 13.7 mmHg. The maximum decrease in mean retinal thickness was observed at four weeks following the treatment and was 365  μm (-267  μm) and visual acuity improved by an average of two lines and was 0.6 logMAR. The largest increase in mean retinal thickness to average of 528  μm (+164  μm) occurred at 16 weeks and the average BCVA was 0.614 lines BCVA logMAR. In one eye, there was a steroid cataract development after the third dose of dexamethasone implant of 0.7 mg.



The intravitreal dexamethasone implant treatment of patients with persistent diabetic macular edema in whom laser photocoagulation proved to be ineffective and as a result they required a monthly injection of anti-VEGF factors (Ranibizumab, Bevacizumab) may be a good alternative to extending the interval of injections. However, reinjections involve a high risk of developing poststeroid cataracts, which is not without significance in middle-aged patients.
A phase 1 and pharmacokinetic study of gemcitabine and oxaliplatin in patients with solid tumors

This dose escalation study aimed to determine the recommended doses, toxicity and pharmacokinetics of oxaliplatin and gemcitabine given on days 1 and 8 every 21 days. This schedule may maximize dose intensity of both drugs with acceptable or reduced toxicity.  Eligible patients had solid malignancies, no more than two prior courses of chemotherapy, ECOG performance status 0–2, neurotoxicity ≤ NCI-CTC grade 1 and adequate organ function. Dose escalation commenced at oxaliplatin 40 mg/m2 and gemcitabine 750 mg/m2, both given on days 1 and 8 every 21 days, and reached oxaliplatin 80 mg/m2 and gemcitabine 1,500 mg/m2. The two highest dose levels were each expanded to six patients to gain additional toxicity data.  There were no dose limiting toxicities related to treatment and an MTD was not reached. Five patients (24%) had grade 3 neutropenia, without associated infection, and seven patients (33%) had grade 3/4 thrombocytopenia. Neurotoxicity was mild and no worse than grade 1. Two patients with mesothelioma (10%) had partial responses and 11 patients (52%) had disease stabilization. No pharmacokinetic interaction between oxaliplatin and gemcitabine was detected. Dose intensity was maximal at level 4 (oxaliplatin 70 mg/m2 and gemcitabine 1,250 mg/m2).  This schedule allows oxaliplatin and gemcitabine to be delivered at the full dose intensity of each drug with excellent tolerability and predictable pharmacokinetics. The recommended doses for phase II studies are oxaliplatin 70 mg/m2 and gemcitabine 1,250 mg/m2 on days 1 and 8 every 21 days.
The Reliability and Validity of the Norwegian Version of the Quality of Life in Late-Stage Dementia Scale.

To translate the Quality of Life in Late-Stage Dementia (QUALID) Scale into Norwegian, and to evaluate the test-retest reliability and validity of the scale.



QUALID was translated according to standardised procedures. Residents with dementia living in nursing homes were included in the study and assessed using QUALID, Cornell Scale for Depression in Dementia, Neuropsychiatric Inventory, Physical Self-Maintenance Scale and Clinical Dementia Rating Scale.



Cronbach's α of QUALID was 0.79. In the reliability study, the intra-class correlation was 0.83. The validity study showed a strong association between depressive symptoms and QUALID, and a moderate association between QUALID and assessments of level of functioning and agitation.



The Norwegian version of QUALID is a reliable and valid scale for assessing quality of life in nursing home residents with dementia.
Radiological correlates and clinical implications of the paradoxical lung function response to β₂ agonists: an observational study.

Bronchodilator response has been noted in a significant proportion of patients with chronic obstructive pulmonary disease (COPD). However, there are also reports of a paradoxical response to β₂ agonists resulting in bronchoconstriction. Asymptomatic bronchoconstriction is likely to be far more common than is symptomatic bronchoconstriction with β₂ agonists, but no systematic studies have been done. We assessed the prevalence of paradoxical response in current and former smokers with and without COPD, and its radiological correlates and clinical implications.



Non-Hispanic white and African-American patients (aged 45-80 years) from a large multicentre study COPDGene were classified into two groups on the basis of a paradoxical response, defined as at least a 12% and 200 mL reduction in forced expiratory volume in 1 sec (FEV₁) or forced vital capacity (FVC), or both, after administration of a shortacting β₂ agonist (180 μg salbutamol).



Patients were recruited from January, 2008, to June, 2011. 9986 (96%) of 10,364 patients enrolled in the COPDGene study were included in the analysis population (mean age 59·6 years [SD 9·0]). Paradoxical response was noted in 453 (5%) of 9986 patients and the frequency was similar in patients with COPD (198 [4%] of 4439) and smokers without airflow obstruction (255 [5%] of 5547). Compared with white patients, a paradoxical response was twice as common in African-American patients (227 [7%] of 3282 vs 226 [3%] of 6704; p<0·0001). In the multivariate analyses, African-American ethnic origin (adjusted odds ratio 1·89, 95% CI 1·50-2·39; p<0·0001), less emphysema (0·96, 0·92-0·99; p=0·023), and increased wall-area percentage of the segmental airways (1·04, 1·01-1·08; p=0·023) were independently associated with a paradoxical response. A paradoxical response was independently associated with worse dyspnoea (adjusted β for Modified Medical Research Council Dyspnoea Scale 0·12 [95% CI 0·00 to 0·24]; p=0·05), lower 6 min walk distance (-45·8 [-78·5 to -13·2]; p=0·006), higher Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) index (0·31 [0·19 to 0·43]; p<0·0001), and a greater frequency of severe exacerbations (increased by a factor of 1·35, 1·00-1·81; p=0·048).



Paradoxical response to β₂ agonists is associated with respiratory morbidity and is more common in African-Americans. These findings might have implications for the use of β2agonists in some patients.
Reversible gene knockdown in mice using a tight, inducible shRNA expression system

Carboplatin/paclitaxel is the chemotherapy of choice for advanced ovarian cancer, both in first line and in platinum-sensitive recurrence. Although a significant proportion of patients have some neurotoxicity during treatment, the long-term outcome of chemotherapy-induced neuropathy has been scantly studied. We retrospectively assessed the prevalence of residual neuropathy in a cohort of patients in clinical remission after first-line carboplatin/paclitaxel for advanced ovarian cancer. 120 patients have been included in this study (101 participating in a multicentre phase III trial evaluating the efficacy of consolidation treatment with topotecan, and 19 treated at the National Cancer Institute of Naples after the end of the trial). All patients received carboplatin (AUC 5) plus paclitaxel (175 mg/m2) every 3 weeks for 6 cycles, completing treatment between 1998 and 2003. Data were collected between May and September 2004. Residual sensory and motor neurotoxicity were coded according to the National Cancer Institute – Common Toxicity Criteria. 55 patients (46%) did not experience any grade of neurological toxicity during chemotherapy and of these none had signs of neuropathy during follow-up. The other 65 patients (54%) had chemotherapy-induced neurotoxicity during treatment and follow-up data are available for 60 of them. Fourteen out of 60 patients (23%) referred residual neuropathy at the most recent follow-up visit, after a median follow up of 18 months (range, 7–58 months): 12 patients had grade 1 and 2 patients grade 2 peripheral sensory neuropathy; 3 patients also had grade 1 motor neuropathy. The remaining 46/60 patients (77%) had no residual neuropathy at the moment of interview: recovery from neurotoxicity had occurred in the first 2 months after the end of chemotherapy in 22 (37%), between 2 and 6 months in 15 (25%), or after more than 6 months in 9 patients (15%). Considering all 120 treated patients, there was a 15% probability of persistent neurological toxicity 6 months after the end of chemotherapy. A significant proportion of patients with advanced ovarian cancer treated with first-line carboplatin/paclitaxel suffer long-term residual neuropathy. This issue should be carefully taken into account before considering re-treatment with the same agents in sensitive recurrent disease.
Tolerability and efficacy of memantine add-on therapy to rivastigmine transdermal patches in mild to moderate Alzheimer's disease: a multicenter, randomized, open-label, parallel-group study.

To compare the tolerability and efficacy of combination therapy of memantine plus rivastigmine patch with rivastigmine patch monotherapy in patients with mild to moderate Alzheimer's disease (AD).



In this multicenter, randomized, open-label study, patients entered an 8-week run-in period (a 5 cm 2 rivastigmine patch for 4 weeks, then a 10 cm(2) patch for 4 weeks) followed by 16 weeks of memantine plus rivastigmine patch or rivastigmine patch monotherapy. The primary outcome measure was the retention rate at the end of the trial.



Overall, 88 and 84 patients received rivastigmine patch with and without memantine, respectively, and of these, 77 (87.5%) and 70 (83.3%) patients completed the study. The difference in retention rate was not significant (95% confidence interval: -6.3-14.7%). The incidence of adverse events (AEs) (53.4 vs. 50.6%) and discontinuation due to AEs (6.8 vs. 4.8%) were not different between patients with and without memantine. The most frequent AEs were skin irritation in patients with and without memantine (42.0 vs. 34.9%, p = 0.71), but discontinuation due to skin irritation was rare (4.5 vs. 2.4%, p = 0.74). The incidence of gastrointestinal AEs was very low in patients with and without memantine (nausea, 2.3 vs. 1.2%; vomiting, 1.1 vs. 1.2%). The Korean Version of the Cohen Mansfield Agitation Inventory scores favored rivastigmine patch monotherapy at the end of treatment (p = 0.01). Changes in other efficacy measures were similar between the groups.



There were no significant differences in tolerability and safety between the treatment groups. The combination therapy of memantine plus rivastigmine patch did not show an advantage over rivastigmine patch monotherapy on efficacy analyses. The sample size for comparing tolerability may have been too small to detect a difference of efficacy between the two groups.