nils-herrmann/clean_scirepeval huggingface dataset:
Intrahepatic Cholestasis of Pregnancy with Severe Elevation of Bile Acids in the Setting of Acute Hepatitis C Infection

Intrahepatic cholestasis of pregnancy (ICP) is a complication of pregnancy resulting in elevation of serum bile acid levels. ICP is often associated with underlying liver disease, including hepatitis C. Bile acids in relationship to the acute infection of hepatitis C virus have not yet been delineated in the literature. A 26-year-old gravida 4 para 2103 with dichorionic, diamniotic twin gestation and history of intravenous drug abuse developed ICP in the setting of acute hepatitis C infection. In addition to clinical symptoms of pruritus and right upper quadrant pain, she developed severe elevation in bile acids, 239 micromol/L, and transaminitis aspartate aminotransferase 1033 U/L, and alanine aminotransferase 448 U/L. She received ursodeoxycholic acid and antenatal testing was performed. Patient delivered vaginally at 33-week gestation following preterm rupture of membranes. Neonates were admitted to NICU and had uncomplicated neonatal courses. In the setting of ICP with significant transaminitis and severe elevation of bile acids, consideration of acute viral hepatitis is important, especially considering the worsening opioid epidemic and concurrent increase in intravenous drug use in the United States. Further study is needed regarding the acute form of HCV infection and its effect on ICP and associated bile acids.
Blood transfusion for acute decompensated heart failure--friend or foe?

In acute coronary syndromes (ACSs), blood transfusion (BT) has been associated with worse outcomes. The impact of BT among patients with acute decompensated heart failure (ADHF) remains unknown.



Propensity score analysis of patients with ADHF with and without BT in a national heart failure (HF) survey was used in this study.



Of the 4,102 enrolled patients, 2,335 had ADHF, of whom 166 (7.1%) received BT. These patients were older (75.6% vs 73.6%, P = .04), more likely to be females (54.8% vs 43.9%, P = .007), more likely to have diabetes (59.0% vs 51.1%, P = .04) and renal dysfunction (59.0% vs 40.2%, P < .001), and more likely to receive inotropes (16.9% vs 8.0%, P < .001), but they had similar rates of ACS (41.0% vs 39.4%, P = .69) and prior HF (64.5% vs 70.0%, P = .23). Nadir hemoglobin levels were commonly <10 g/dL in BT patients (92.7% vs 8.0%); 15 BT patients had bleeding complications, of which 10 are major bleeding. Major predictors for BT were ACS (OR 1.85, 95% CI 1.15-2.96), inotropes use (OR 2.36, 95% CI 1.22-4.55), and nadir hemoglobin (OR 0.18 per 1 g/dL increase, 95% CI 0.14-0.22). In-hospital, 30-day, 1-year, and 4-year unadjusted mortality rates were higher for BT patients (10.8% vs 5.2%, P = .02; 11.0% vs 8.5%, P = .27; 39.6% vs 28.5%, P = .03; 69.5% vs 59.5%, P = .01, respectively). However, in 103 propensity-matched pairs (c-statistic 0.97), short-term mortality tended to be lower with BT (8.7% vs 14.6%, P = .20; 9.7% vs 18.4%, P = .08; 38.8% vs 42.7%, P = .59; and 72.8% vs 76.7%, P = .52, respectively).



Acute decompensated HF patients receiving BT had worse clinical features and unadjusted outcomes, but BT per se seemed to be safe and perhaps even beneficial.
Phase 1 study of topical perillyl alcohol cream for chemoprevention of skin cancer.

Perillyl alcohol (POH) is a natural product derived from plants such as cherry and lavendin. Previous studies have indicated that topical POH inhibits ultraviolet (UV) B-induced skin carcinogenesis in vivo, and it may be an effective chemopreventive agent for skin cancer. We performed a 1-mo, first-in-man, Phase 1 trial of topically administered POH cream in human subjects. Endpoints included safety and evaluation of any histopathological changes in skin after 1 mo use of POH cream. We randomized 25 subjects with normal, healthy skin with little or no sun damage and no history of skin cancer in a double-blind fashion to receive topical POH (0.76% wt/wt) on 1 forearm with placebo cream applied to the other forearm twice daily for 30 days. Subjects were monitored for toxicity, and a 4 mm punch biopsy in the treated area was performed at the end of study for histopathological evaluation. The topical cream was well tolerated. No serious cutaneous toxicities, systemic toxicities, or histopathological abnormalities were observed. A total of 8 subjects (32%) reported mild adverse events possibly or probably related to use of cream including reversible appearance of 1 to 2 small papules. However, there was no significant difference between lesions appearing on the POH treated forearm vs. the placebo-treated forearm.
Adolescent Smoking Cessation With Bupropion: The Role of Adherence.

While many medications can be effective aids to quitting tobacco, real world adherence to smoking cessation medications may render a potentially effective medication ineffective. The present study investigated the role of adherence on treatment outcomes in a bupropion dose-response study among adolescent smokers trying to quit smoking.



Three hundred twelve adolescent boys (n = 143) and girls (n = 169) between the ages of 14-17 were enrolled in the study, and were randomly assigned to use either 300 mg, 150 mg or placebo bupropion to quit smoking. Among the eligibility criterion, participants had to smoke at least six cigarettes per day, be motivated to quit smoking (self report), have an exhaled carbon monoxide level greater than or equal to 10 ppm, and report at least two previous quit attempts. Adherence to medication was determined by both self-report and actual counts of unused medication and empty medication packaging. Smoking status was determined by a combination of self-report and biochemical verification (breath carbon monoxide and urine cotinine).



Cotinine-confirmed quit rates were significantly higher as a function of high adherence (20.69%) relative to low adherence (0.00%) in the 300-mg Bupropion Sustained Release group. Overall adherence in all study conditions in this highly controlled study was high (74%), but was significantly lower in non-white participants.



Effectiveness of bupropion for adolescent smoking cessation is contingent on achieving high rates of medication adherence, but considerable variations in adherence impacted outcomes.



Few studies have assessed the safety and efficacy of medications to help adolescent smokers quit, and we conducted one such study assessing bupropion. In this analysis of that original study, we assess the role of adherence in use of medication and quit rates. We found that adherence was related to outcomes, particularly in the 300-mg dose of bupropion.
Efficacy and tolerability of sumatriptan in the treatment of multiple migraine attacks

This cross-over, double blind, randomized, multicentre study evaluated the consistency of efficacy and safety of oral sumatriptan in 233 migraneurs. The patients received 50 mg oral sumatriptan or placebo for the treatment of 12 migraine attacks. Within each group of 4 attacks, three were treated with sumatriptan and one with placebo, according to a randomization list. Over all the attacks, the efficacy rate was statistically significant for sumatriptan against placebo at 2 or 4 hours (2 hours: sumatriptan 60%, PLO 38%, p<0.001; 4 hours sumatriptan 79%, PLO 47%, p<0.001). Oral sumatriptan was similarly effective at relieving the associated symptoms and at reducing clinical disability in most attacks. The incidence of adverse events did not differ between treatment groups. All the events recorded were mild to moderate as intensity and resolved spontaneously.
Exercise tolerance in patients with angina pectoris after pentaerythritol trinitrate and alprenolol studied by two different methods

Exercise tolerance has been studied by two different methods, heart-rate-controlled exercise and stepwise increased load, in 12 patients with angina pectoris. The response to a beta-adrenergic blocking agent, alprenolol, and an alkyl nitrate derivative, pentaerythritol trinitrate (PETRIN) was studied by the two methods after double-blind administration of the drugs. Rating scales were used to quantitate the degree of dyspnoea, angina pectoris and tiredness in the legs. After PETRIN both methods showed significant increases in exercise tolerance (19 and 21 per cent). The heart-rate-controlled test showed a significant increase (33%) after alprenolol, but the change was not significant by the other method. In the patients studied, heart-rate-controlled exercise discriminated between active drug and placebo better than the stepwise increased load test, what might have been due to more optimal matching of the loads obtained in the heart-rate-controlled test. Indications are given about how to design an exercise study in patients with angina pectoris.
Long-term open-label study of tanezumab for moderate to severe osteoarthritic knee pain.

This study was designed to evaluate the long-term safety and effectiveness of repeated doses of the humanized anti-nerve growth factor antibody, tanezumab, during open-label treatment of patients with OA knee pain.



The current study (clinicaltrials.gov identifier: NCT00399490) was a multicenter, phase II, open-label, multiple-dose extension of an earlier randomized clinical trial. All patients (N=281) received infusions of tanezumab 50μg/kg on Days 1 and 56 with subsequent doses administered at 8-week intervals (up to a total of eight infusions). The primary endpoint of this study was safety. Effectiveness evaluations included overall knee pain, Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index subscales, and subject global assessment (SGA) of response to therapy on 0-100 point visual analog scales.



Repeated administration of tanezumab resulted in a low incidence of treatment-related adverse events (AEs; 7.5%). The rate of serious AEs was also low (2.8%) with none considered treatment-related. Few AEs of abnormal peripheral sensation were reported; hypoesthesia was reported by nine patients (3.2%), paresthesia by seven patients (2.5%), and hyperesthesia, peripheral neuropathy, and sensory disturbance were each reported by one patient (0.4% for each). Most AEs of abnormal peripheral sensation were rated as mild (95%) and the majority (65%) resolved before study completion. At Week 8, overall knee pain and SGA improved from baseline by a mean (± standard error) of -12.8 (±1.78) and 8.0 (±1.66), respectively. Similar improvements occurred for WOMAC subscales.



Repeated injections of tanezumab in patients with moderate to severe knee OA provide continued pain relief and improved function with a low incidence of side effects. Additional studies to define the efficacy and duration of pain reduction and to provide a more complete assessment of long-term safety are warranted.
Purified black tea theaflavins and theaflavins/catechin supplements did not affect serum lipids in healthy individuals with mildly to moderately elevated cholesterol concentrations.

Ingestion of tea flavonoids found in both green and black tea is linked to cardiovascular health benefits such as lowering serum lipids. Evidence for a cholesterol-lowering benefit of green or black tea consumption from human intervention studies is, however, conflicting and active components responsible for the effect have not yet been clearly identified.



In a randomized, double-blind, placebo-controlled, parallel design study the effects of ingesting a purified black tea theaflavins (TFs) powder alone or in combination with catechin (TFs/catechins) on lowering serum total (TC) and LDL-cholesterol (LDL-c) were assessed.



In total, 102 mildly to moderately hypercholesterolemic (TC and LDL-c: 5.70 +/- 0.74 and 3.97 +/- 0.61 mmol/L, respectively) subjects (67 men and 35 women) were randomly assigned to consume once daily one capsule of one of the 3 treatments: TFs (providing 77.5 mg), TFs/catechins (providing 75.0 mg TFs plus 150.0 mg catechins and 195.0 mg of other polyphenols), or placebo (cellulose).



Serum TC and LDL-c concentrations did not differ significantly among the 3 treatments as assessed at 4, 8, and 11 weeks using analysis of covariance (p = 0.1187 and p = 0.1063, respectively). Although changes over time from baseline to week 11 were significant for TC and LDL-c (p = 0.0311 and p = 0.0269, respectively), this decrease over time was seen in the TFs and placebo groups.



In this human intervention study, no statistically significant LDL-c lowering effect was seen with either TFs alone or the TFs/catechins combination as compared to placebo. Based on these findings it cannot be concluded that tea flavonoids such as theaflavins and catechins are responsible for a putative cholesterol-lowering effect of black tea, at least not with the daily dose applied in the present study.
The effect of initial therapy with the fixed-dose combination of sitagliptin and metformin compared with metformin monotherapy in patients with type 2 diabetes mellitus.

This study was conducted to compare the glycaemic efficacy and safety of initial combination therapy with the fixed-dose combination of sitagliptin and metformin versus metformin monotherapy in drug-naive patients with type 2 diabetes.



This double-blind study (18-week Phase A and 26-week Phase B) randomized 1250 drug-naÏve patients with type 2 diabetes [mean baseline haemoglobin A1c (HbA1c) 9.9%] to sitagliptin/metformin 50/500 mg bid or metformin 500 mg bid (uptitrated over 4 weeks to achieve maximum doses of sitagliptin/metformin 50/1000 mg bid or metformin 1000 bid). Results of the primary efficacy endpoint (mean HbA1c reductions from baseline at the end of Phase A) are reported herein.



At week 18, mean change from baseline HbA1c was -2.4% for sitagliptin/metformin FDC and -1.8% for metformin monotherapy (p < 0.001); more patients treated with sitagliptin/metformin FDC had an HbA1c value <7% (p < 0.001) versus metformin monotherapy. Changes in fasting plasma glucose were significantly greater with sitagliptin/metformin FDC (-3.8 mmol/l) versus metformin monotherapy (-3.0 mmol/l; p < 0.001). Homeostasis model assessment of β-cell function (HOMA-β) and fasting proinsulin/insulin ratio were significantly improved with sitagliptin/metformin FDC versus metformin monotherapy. Baseline body weight was reduced by 1.6 kg in each group. Both treatments were generally well tolerated with a low and similar incidence of hypoglycaemia. Abdominal pain (1.1 and 3.9%; p = 0.002) and diarrhoea (12.0 and 16.6%; p = 0.021) occurred significantly less with sitagliptin/metformin FDC versus metformin monotherapy; the incidence of nausea and vomiting was similar in both groups.



Compared with metformin monotherapy, initial treatment with sitagliptin/metformin FDC provided superior glycaemic improvement with a similar degree of weight loss and lower incidences of abdominal pain and diarrhoea.
Diabetic retinopathy is not associated with carbonic anhydrase gene polymorphisms

Carbonic anhydrase is elevated in the vitreous of patients with proliferative diabetic retinopathy (PDR). This study aimed to determine if common polymorphisms in the carbonic anhydrase (CA) gene influence susceptibility to diabetic retinopathy (DR).



In this multicentered study, a total of 235 control subjects with no DR, 158 subjects with nonproliferative DR (NPDR), 132 with proliferative DR (PDR), and 93 with clinically significant macular edema (CSME) were recruited. Blinding DR was defined as severe NPDR, PDR or CSME. DR subjects were drawn from both type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) populations. Ten tag single nucleotide polymorphisms were selected to cover the majority of genetic diversity across the CA gene.



After adjustments were made for sex, disease duration, and HbA(1)c, no associations were found between any CA polymorphisms or haplotypes with any type of retinopathy in T1DM or T2DM.



Sequence variation in CA is not associated with the risk of developing retinopathy in T1DM or T2DM and increases the likelihood that elevated vitreous CA may be a consequence rather than cause of DR. Further genetic studies are required to have a better understanding of the pathogenesis of this debilitating diabetic complication.
Superoxide dismutase and cytokines in chronic patients with schizophrenia: association with psychopathology and response to antipsychotics

Both schizophrenia and oxidative stress have been associated with immune system abnormalities in interleukin-2 and -6 (IL-2; IL-6) and increases in superoxide dismutase (SOD) activity. These abnormalities may improve during antipsychotic drug treatment that reduces symptoms in schizophrenic patients. Subjects included 30 healthy controls (HC) and 78 schizophrenic (SCH) in-patients who were randomly assigned to 12 weeks of double-blind treatment with risperidone 6 mg/day or haloperidol 20 mg/day. Ratings using the Positive and Negative Syndrome Scale (PANSS) were correlated with blood SOD and serum IL-2 levels. SCH patients who were medication-free for 2 weeks had greater SOD, IL-2, and IL-6 levels than HC. At baseline, these SOD elevations were associated with higher PANSS total scores and the IL-2 elevations with lower PANSS positive symptom scores. The SOD and IL-2 levels in the SCH were also positively correlated. After treatment, PANSS positive symptoms and both SOD and IL-2 showed a significant decrease, but IL-6 showed no change. The SOD and IL-2 reductions were correlated with the reductions in PANSS total score, and SOD reductions also correlated with positive subscore reductions. Females showed these associations more strongly than males. Our results suggest that the dysregulation in the cytokine system and oxidative stress in patients with schizophrenia is implicated in clinical symptoms and is improved at least partially with antipsychotic treatment. The stronger associations in females deserve further study and confirmation.
Comparing continuous venovenous hemodiafiltration and peritoneal dialysis in critically ill patients with acute kidney injury: a pilot study.

There are few reports on the role of peritoneal dialysis in critically ill patients requiring continuous renal replacement therapies.



Patients with acute kidney injury and multi-organ involvement were randomly allotted to continuous venovenous hemodiafiltration(CVVHDF, group A) or to continuous peritoneal dialysis (CPD, group B). Cause and severity of renal failure were assessed at the time of initiating dialysis. Primary outcome was the composite correction of uremia, acidosis, fluid overload, and hyperkalemia. Secondary outcomes were improvement of sensorium and hemodynamic instability, survival, and cost.



Groups A and B comprised 25 patients each with mean ages of 45.32 ± 17.53 and 48.44 ± 17.64 respectively. They received 21.68 ± 13.46 hours and 66.02 ± 69.77 hours of dialysis respectively (p = 0.01). Composite correction was achieved in 12 patients of group A (48%) and in 14 patients of group B (56%). Urea and creatinine clearances were significantly higher in group A (21.72 ± 10.41 mL/min and 9.36 ± 4.93 mL/min respectively vs. 22.13 ± 9.61 mL/min and 10.5 ± 6.07 mL/min, p < 0.001). Acidosis was present in 21 patients of group A (84%) and in 16 of group B (64%); correction was better in group B (p < 0.001). Correction of fluid overload was faster and the amount of ultrafiltrate was significantly higher in group A (20.31 ± 21.86 L vs. 5.31 ± 5.75 L, p<0.001). No significant differences were seen in correction of hyperkalemia, altered sensorium, or hemodynamic disturbance. Mortality was 84% in group A and 72% in group B. Factors that influenced outcome were the APACHE (Acute Physiology and Chronic Health Evaluation) II score (p=0.02) and need for ventilatory support (p < 0.01). Cost of disposables was higher in group A than in group B [INR 7184 ± 1436 vs. INR 3009 ± 1643, p < 0.001 (US$1=INR 47)].



Based on this pilot study, CPD may be a cost-conscious alternative to CVVHDF; differences in metabolic and clinical outcomes are minimal.
Problem areas and the combination of wall-units to satisfy room relation specification between rooms

Given the 5-10 year goal of a computer program to design buildings, this paper discusses a proposed outline of problem areas. These problems are considered stubborn but tractable and need be systematically resolved. A program is described which investigates the problem of combining wall-units into a wall which satisfies relation value specification between rooms.
 Architectural design automation has apparently progressed beyond location programs to the point at which individual researchers are investigating problem areas whose output may be a partial program rather than a complete package. The evaluation of such a project should then fall upon (1) the recognition of relevant problem areas and (2) its progress demonstrated by the program within the context of an overall, long term goal.
The structure of genetic and environmental risk factors for phobias in women.

To explore the genetic and environmental factors underlying the co-occurrence of lifetime diagnoses of DSM-IV phobia.



Female twins (n=1430) from the population-based Norwegian Institute of Public Health Twin Panel were assessed at personal interview for DSM-IV lifetime specific phobia, social phobia and agoraphobia. Comorbidity between the phobias were assessed by odds ratios (ORs) and polychoric correlations and multivariate twin models were fitted in Mx.



Phenotypic correlations of lifetime phobia diagnoses ranged from 0.55 (agoraphobia and social phobia, OR 10.95) to 0.06 (animal phobia and social phobia, OR 1.21). In the best fitting twin model, which did not include shared environmental factors, heritability estimates for the phobias ranged from 0.43 to 0.63. Comorbidity between the phobias was accounted for by two common liability factors. The first loaded principally on animal phobia and did not influence the complex phobias (agoraphobia and social phobia). The second liability factor strongly influenced the complex phobias, but also loaded weak to moderate on all the other phobias. Blood phobia was mainly influenced by a specific genetic factor, which accounted for 51% of the total and 81% of the genetic variance.



Phobias are highly co-morbid and heritable. Our results suggest that the co-morbidity between phobias is best explained by two distinct liability factors rather than a single factor, as has been assumed in most previous multivariate twin analyses. One of these factors was specific to the simple phobias, while the other was more general. Blood phobia was mainly influenced by disorder specific genetic factors.
Cognitive behaviour therapy for menopausal symptoms following breast cancer treatment: Who benefits and how does it work?

Cognitive behaviour therapy (CBT) has been found to reduce the impact of menopausal symptoms, hot flushes and night sweats. This study investigates the moderators and mediators of CBT for women who had problematic menopausal symptoms following breast cancer treatment.



Analysis of 96 patients with breast cancer induced menopausal symptoms recruited to the MENOS1 trial; 47 were randomly assigned to Group CBT and 49 to usual care. Questionnaires were completed at baseline, 9 and 26 weeks post randomisation. Potential moderators and mediators, including sociodemographic, clinical and psychological factors, of the treatment effect on the primary outcome were examined.



CBT was effective at reducing problem rating at 9 weeks regardless of age, BMI, time since breast cancer diagnosis, menopausal status at time of diagnosis, or type of cancer treatment (radiotherapy or chemotherapy or endocrine treatment). The treatment effect was significantly greater in women not receiving chemotherapy, those with higher levels of psychological distress at baseline and for non-white women. Beliefs about control/coping with hot flushes were the main mediators of improvement in problem rating following CBT. Beliefs about hot flushes in a social context, depressed mood and sleep problems were also identified as mediators.



These findings suggest that CBT is widely applicable for breast cancer patients who are experiencing treatment related menopausal symptoms, and that CBT works mainly by changing beliefs and improving mood and sleep.