nils-herrmann/clean_scirepeval huggingface dataset:
Feasibility study of a clinically-integrated randomized trial of modifications to radical prostatectomy

Numerous technical modifications to radical prostatectomy have been proposed. Such modifications are likely to lead to only slight improvements in outcomes. Although small differences would be worthwhile, an appropriately powered randomized trial would need to be very large, and thus of doubtful feasibility given the expense, complexity and regulatory burden of contemporary clinical trials. We have proposed a novel methodology, the clinically-integrated randomized trial, which dramatically streamlines trial procedures in order to reduce the marginal cost of an additional patient towards zero. We aimed to determine the feasibility of implementing such a trial for radical prostatectomy.



Patients undergoing radical prostatectomy as initial treatment for prostate cancer were randomized in a factorial design to involvement of the fascia during placement of the anastomotic sutures, urethral irrigation, both or neither. Endpoint data were obtained from routine clinical documentation. Accrual and compliance rates were monitored to determine the feasibility of the trial.



From a total of 260 eligible patients, 154 (59%) consented; 56 patients declined to participate, 20 were not approached on recommendation of the treating surgeon, and 30 were not approached for logistical reasons. Although recording by surgeons of the procedure used was incomplete (~80%), compliance with randomization was excellent when it was recorded, with only 6% of procedures inconsistent with allocation. Outcomes data was received from 71% of patients at one year. This improved to 83% as the trial progressed.



A clinically-integrated randomized trial was conducted at low cost, with excellent accrual, and acceptable compliance with treatment allocation and outcomes reporting. This demonstrates the feasibility of the methodology. Improved methods to ensure documentation of surgical procedures would be required before wider implementation.
The Global Longitudinal Study of Osteoporosis in Women (GLOW): rationale and study design

The Global Longitudinal study of Osteoporosis in Women (GLOW) is a prospective cohort study involving 723 physicians and 60,393 women subjects ≥55 years. The data will provide insights into the management of fracture risk in older women over 5 years, patient experience with prevention and treatment, and distribution of risk among older women on an international basis. Data from cohort studies describing the distribution of osteoporosis-related fractures and risk factors are not directly comparable and do not compare regional differences in patterns of patient management and fracture outcomes. The GLOW is a prospective, multinational, observational cohort study. Practices typical of each region were identified through primary care networks organized for administrative, research, or educational purposes. Noninstitutionalized patients visiting each practice within the previous 2 years were eligible. Self-administered questionnaires were mailed, with 2:1 oversampling of women ≥65 years. Follow-up questionnaires will be sent at 12-month intervals for 5 years. A total of 723 physicians at 17 sites in ten countries agreed to participate. Baseline surveys were mailed (October 2006 to February 2008) to 140,416 subjects. After the exclusion of 3,265 women who were ineligible or had died, 60,393 agreed to participate. GLOW will provide contemporary information on patterns of management of fracture risk in older women over a 5-year period. The collection of data in a similar manner in ten countries will permit comparisons of patient experience with prevention and treatment and provide insights into the distribution of risk among older women on an international basis.
[Association between polymorphisms of ins/del in the 5-HTT gene and T102C in the 5HTR2A gene and the drug response for escitalopram and nortriptyline in depressed patients].

The role of the Serotonin receptor 5HT2A and Serotonin transporter 5HTTLPR polymorphisms was suggested in the pathogenesis of depression and the therapeutic response to serotonergic drugs. The aim of this study was to find a possible association between polymorphisms of ins/del in the 5-HTT gene and T102C in the 5HTR2A gene and drug response for escitalopram and nortriptyline in depressed patients.



We analysed 90 patients (21 male and 69 females), in the age range 19-68 years, suffering from depressive disorder of at least moderate severity meeting the research criteria of ICD-10 and DSM-IV for major depression. All patients were part of the GENDEP study and were given the written consent for the study. The project was accepted by the local ethics committee. The subjects were randomized to one of the 2 different treatment regimes: (1) patients who received the serotoninergic drug--escitalopram (n=51) with a specified dose range of 10-20 mg/day. (2) patients treated by a noradrenergic drug--nortriptyline (n=39) with the dose range of 75-150 mg/day. The efficacy of treatment was defined by a reduction > or =50% of the total score of the Hamilton scale in the 8th week of treatment. Genotypes for polymorphisms of the ins/del 5-HTT gene and T102C 5HTR2A gene were established by the PCR-RFLP method in the Laboratory of Psychiatric Genetics of the Psychiatric Clinic. Statistical analysis was performed with Statistica version 7.1.



The results of the pharmacogenetic analysis, showed no association between the effects of serotoninergic (escitalopram) or noradrenergic (noradrenaline) therapy and the genotypes or alleles polymorphisms of the 5HTT and 5HTR2A genes.
[Dialysis and the risk of poverty].

For patients with severe kidney failure, the only alternative to transplantation today is an enduring dialysis treatment. But dialysis is associated with manifold physical and social restrictions. The study analyses the psychosocial consequences of the chronic disease of renal insufficiency: Does chronic kidney failure increase the patients' risk to sink into poverty? SAMPLE/ In the year 2006 625 dialysis patients participated in an enquiry in 77 dialysis centres in Germany. The newly developed questionnaire included 19 items about social situation, treatment conditions, and quality of life. The response rate was 54.3%. The analyses were calculated using descriptive statistics and discriminatory analyses.



51.8% of the patients lived in the new German federal states (the former GDR), 44.9% are female. The mean age of the sample was 62.2 years. 57.5% of the participants were married or cohabited. There was at least one person aged younger than 18 years in 12% of the households. 54.8% of the respondents had a German CSE, 25.3% had a German Remedial School Certificate of Completion, and 12.4% had a German Abitur (German university entrance qualification). At the time of the enquiry, 60.2% of the patients were below the poverty level (60% of the mean income in Germany). Important impact factors for an existence above the poverty level were the number of persons per household and the age of the participants. The more persons per household, the greater was the risk to be below the poverty level. Households with more than two persons had a significantly higher risk to be below the poverty level (OR=63.3). Persons aged younger than 50 years had a significantly higher risk to be below the poverty level than those aged 50 years or older (OR=2.0).



Chronic renal insufficiency is associated with a higher poverty risk if the patients feature specific attributes. Although living alone is often regarded as a poverty risk because larger households usually have more opportunities to save costs, due to our findings patients living together with several persons in a household are at higher risk to sink into poverty. They are younger or middle-aged and have responsibility to support children or partners. A higher poverty risk results from the fact that they are at a younger age when their dialysis starts and usually receive a lower employment disability pension. The results correspond with data of the German Federal Statistical Office, which show that the number of paupers is greater within younger age groups. Relevant for prevention seems to be the impact of the physician on a possible further occupation of dialysis patients.
The Role of N-Acetylcysteine in the Prevention of Contrast-Induced Nephrotoxicity

To determine the role of prophylactic N-acetylcysteine in the prevention of contrast-induced nephrotoxicity. One hundred and sixteen patients undergoing noncoronary angiography, with or without pre-existing renal impairment, were randomly assigned to receive prophylactic oral N-acetylcysteine or no treatment. Serum creatinine (sCr) was measured prior to angiography and 48 hr after the procedure. Urine samples were collected before and after the examination for measurement of malondialdehyde (MDA) concentration. Contrast-induced nephrotoxicity (CIN) was defined as a rise in serum creatinine of 0.5 mg/dl (44 mmol/l) at 48 hr. Complete data were available on 106 patients, 53 of whom had received N-acetylcysteine. There were no significant differences between the two groups in baseline characteristics, type of angiogram, or volume and concentration of contrast used. Three patients (2.8%), all of whom had received N-acetylcysteine, developed CIN. In the N-acetylcysteine group, the mean serum creatinine in patients with renal impairment was 151.0 ± 44.2 μmol/l prior to the procedure and 155.6 ± 48.6 μmol/l (p = 0.49) after the procedure. Respective values for those without renal impairment were 79.6 ± 15.1 μmol/l and 81.2 ± 20.0 μmol/l (p = 0.65). In the group that had not received N-acetylcysteine, the mean serum creatinine levels before and after the procedure were 150.0 ± 58.1 and 141.4 ± 48.0 μmol/l (p = 0.17) in patients with renal impairment and 79.7 ± 14.2 and 81.4 ± 15.4 μmol/l (p = 0.34) in those without renal impairment. In both groups, no significant change in urinary MDA concentration was observed. There is no benefit to the prophylactic administration of N-acetylcysteine in patients undergoing peripheral angiography using current contrast media.
Concomitant chemoradiation versus radical radiotherapy in advanced squamous cell carcinoma of oropharynx and nasopharynx using weekly cisplatin: a phase II randomized trial.

To know the effectiveness and tolerance of weekly cisplatin added to radiotherapy (RT) in advanced carcinoma of oropharynx and nasopharynx.



Stage II-IV cancer patients were randomly assigned to either radical RT, 70 Gy/35 fractions over 7 weeks (RT arm), or chemoradiotherapy (CRT), cisplatin 40 mg/m² weekly for seven doses plus RT. Primary end points were (i) the responses, (ii) toxicity profile, and (iii) overall survival (OS) in two groups. Study period was from June 2003 to July 2005.



One hundred and fifty-three patients were randomly allocated to the study, 76 in RT arm and 77 in CRT arm. Seventy-one in each arm completed the planned treatment; complete response (CR): 67.1% versus 80.5% in RT and CRT arms (P = 0.04). Grade III and IV toxicity were 16% and 40% in RT and CRT arms, respectively (P = 0.01). There were frequent treatment interruptions (9.3% versus 28.9%; P = 0.003) and hospitalization (20% versus 40.8%) in the CRT group. OS was superior in the CRT arm (P = 0.02): 27 months [95% confidence interval (CI) 15.2-36.8] for RT versus not reached for CRT. Three-year OS was 42% for RT and 62% for CRT group. CRT and CR were independent prognostic factors.



This trial on Indian head and neck squamous cell carcinoma patients confirms that the use of weekly cisplatin is safe and CRT is superior to RT alone resulting in higher OS.
Isoflurane Sedation on the ICU in Cardiac Arrest Patients Treated With Targeted Temperature Management: An Observational Propensity-Matched Study.

Targeted temperature management after cardiac arrest requires deep sedation to prevent shivering and discomfort. Compared to IV sedation, volatile sedation has a shorter half-life and thus may allow more rapid extubation and neurologic assessment.



Observational analysis of clinical data.



University hospital, medical ICU.



Four hundred thirty-two cardiac arrest survivors underwent targeted temperature management; of those, 110 were treated with volatile sedation using an anesthetic conserving device and isoflurane, and 322 received standard IV sedation.



No intervention.



A matched pairs analysis revealed that time on ventilator (difference of median, 98.5 hr; p = 0.003) and length of ICU stay (difference of median, 4.5 d; p = 0.006) were significantly shorter in patients sedated with isoflurane when compared with IV sedation although no differences in neurologic outcome (45% of patients with cerebral performance category 1-2 in both groups) were observed. Significant hypercapnia occurred more frequently during anesthetic conserving device use (6.4% vs 0%; p = 0.021).



Volatile sedation is feasible in cardiac arrest survivors. Prospective controlled studies are necessary to confirm the beneficial effects on duration of ventilation and length of ICU stay observed in our study. Our data argue against a major effect on neurologic outcome. Close monitoring of PaCO2 is necessary during sedation via anesthetic conserving device.
Randomized controlled trial to investigate the impact of anticoagulation on the incidence of splenic or portal vein thrombosis after laparoscopic splenectomy.

Splenic and portal vein thrombosis (SPVT) is a potentially life-threatening complication of splenectomy. There is a paucity of studies examining the role of prophylactic pre- and postoperative anticoagulation in the prevention of this complication. We designed a prospective randomized controlled trial (RCT) to more rigorously address the impact of prophylactic anticoagulation on the incidence of asymptomatic or symptomatic SPVT, detected on Doppler ultrasound, after laparoscopic splenectomy.



This 2-centre, phase II, prospective, open-label, parallel-assignment RCT compared no postoperative anticoagulation to a regimen of 40 mg of enoxaparin subcutaneously once daily for 21 days. All patients underwent Doppler ultrasonography of the splenoportal system preoperatively and again 14-28 days after surgery to screen for nonocclusive or occlusive thrombosis.



From November 2006 to November 2008, 35 patients were enrolled in the RCT. Four patients withdrew, 1 required conversion to an open procedure and 1 died at 3 months (the cause of death was not related to the study). Of the 29 patients remaining, 15 were randomly assigned to the anticoagulation group and 14 to the nonanticoagulation group. One (3.4%) patient in the treatment group experienced portal thrombosis. Rates of postoperative bleeding were similar in both groups.



This RCT of anticoagulation found a low overall risk of SPVT after laparoscopic splenectomy; however, this is an underpowered study, and further multicentred clinical trials are needed.
Two-year impacts on employment and income among adults receiving antiretroviral therapy in Tamil Nadu, India: a cohort study.

to estimate the economic impact of antiretroviral therapy (ART) on employment and income of treated patients as well as a comparison group of pre-ART patients who receive care and support in Tamil Nadu, India.



a cohort of 1238 HIV-infected patients was followed between 2005 and 2007. Socioeconomic data were collected at 6-month intervals. A total of 515 patients initiated ART during the study period, whereas a comparison group of 723 patients were pre-ART. The impact of ART on four employment outcomes was analyzed: participation in economic activities in the past week, number of hours worked in the past week, individual income earned in the past 30 days and 6 months. Regression models including patient fixed effects were estimated. Data from the comparison group of patients were used to adjust for time trends in employment outcomes.



At 6 months after initiation of ART, patients were 10 percentage points more likely to be economically active (P < 0.01) and worked 5.5 additional hours per week (P < 0.01). These increases were over and above those experienced by the comparison group. The estimated 24-month impacts represent a doubling of patients' employment levels at baseline. At 24 months after ART initiation, employment increases remained large and significant. Effects were almost twice as large for men compared with women. Income earned in the past 30 days and 6 months also rose significantly.



ART resulted in a rapid and sustained increase in employment and income for patients. The results demonstrate that ART can improve the economic outcomes of HIV-infected patients.
Drinking patterns and their predictive factors in CONTROL: a 12-month prospective study in a sample of alcohol-dependent patients initiating treatment.

To describe the drinking patterns and their baseline predictive factors during a 12-month period after an initial evaluation for alcohol treatment.



CONTROL is a single-center, prospective, observational study evaluating consecutive alcohol-dependent patients. Using a curve clustering methodology based on a polynomial regression mixture model, we identified three clusters of patients with dominant alcohol use patterns described as mostly abstainers, mostly moderate drinkers and mostly heavy drinkers. Multinomial logistic regression analysis was used to identify baseline factors (socio-demographic, alcohol dependence consequences and related factors) predictive of belonging to each drinking cluster.



The sample included 143 alcohol-dependent adults (63.6% males), mean age 44.6 ± 11.8 years. The clustering method identified 47 (32.9%) mostly abstainers, 56 (39.2%) mostly moderate drinkers and 40 (28.0%) mostly heavy drinkers. Multivariate analyses indicated that mild or severe depression at baseline predicted belonging to the mostly moderate drinkers cluster during follow-up (relative risk ratio (RRR) 2.42, CI [1.02-5.73, P = 0.045] P = 0.045), while living alone (RRR 2.78, CI [1.03-7.50], P = 0.044) and reporting more alcohol-related consequences (RRR 1.03, CI [1.01-1.05], P = 0.004) predicted belonging to the mostly heavy drinkers cluster during follow-up.



In this sample, the drinking patterns of alcohol-dependent patients were predicted by baseline factors, i.e. depression, living alone or alcohol-related consequences and findings that may inform clinicians about the likely drinking patterns of their alcohol-dependent patient over the year following the initial evaluation for alcohol treatment.
Neopterin production and tryptophan degradation during 24-months therapy with interferon beta-1a in multiple sclerosis patients

Increased synthesis of neopterin and degradation of tryptophan to kynurenine, measured as kynurenine/tryptophan ratio (kyn/trp ratio), are considered in vitro markers of interferon beta-1a (IFNβ-1a) activity. The aim of the study was to investigate the dynamic profile of neopterin and kyn/trp ratio in patients with relapsing remitting multiple sclerosis (RRMS) treated with two different doses of IFNβ-1a over a period of 24 months. RRMS patients (n = 101) received open-label IFNβ-1a 22 mcg (low dose, LD) or 44 mcg (high dose, HD) subcutaneously (sc), three times weekly for 24 months. Serum measurements of neopterin, kyn/trp ratio and neutralizing antibodies (NAbs) were obtained before treatment (i.e., at baseline) and 48 hours post-injection every 3 months thereafter. Clinical assessments were performed at baseline and every 6 months. Changes in biomarkers over time were compared between LD- and HD-group as well as between patients with/without relapses and with/without NAbs using Analysis of Variance and Mann-Whitney tests. Neopterin (p < 0.001) and kyn/trp ratio (p = 0.0013) values increased over time vs baseline in both treatment groups. Neopterin values were higher (p = 0.046) in the HD-compared to the LD-group at every time point with the exclusion of months 21 and 24 of therapy. Conversely, there were no differences between the two doses groups in the kyn/trp ratio with the exclusion of month 6 of therapy (p < 0.05). Neopterin levels were significantly reduced in NAb-positive patients starting from month 9 of therapy (p < 0.05); the same result was observed for kyn/trp ratio but only at month 9 (p = 0.02). Clinical status did not significantly affect neopterin production and tryptophan degradation. Although differences in serum markers concentration were found following IFNβ administration the clinical relevance of these findings needs to be confirmed with more detailed studies.
Use of microsurgery and iloprost in the infantile arterial injuries.

To evaluate the use and advantage of microsurgical intervention and intravenous iloprost administration in delayed infantile artery injuries.



Four patients were followed up and treated in our clinic between June 2003 and June 2006 for infantile artery injuries and distal ischemia. The average age of the 4 infants (3 girls, 1 boy) was 134.7+/-33.6 days. The reason for all of the artery injuries was iatrogenic. Tissue necrosis started in patches in 2 babies who were admitted at the 12(th) hour after ischemia (19(th) and 22(nd) hours), and therefore the artery was repaired by microsurgery. Iloprost infusion was also used in addition to the conservative treatments. The other 2 patients were assessed before the first 12 h after distal ischemia and were treated by iloprost without any surgical intervention. None of the patients lost any tissue or extremities during the 9 months (average) follow-up time. One of our patients died following the ventricular septal defect repair at the 9(th) month after a successful repair of artery.



We believe that intravenous iloprost infusion is very effective in the treatment of distal ischemia when used in addition to the conservative treatment methods for artery injuries in infants.
Effect of augmented atypical antipsychotics on weight change in patients with major depressive disorder in a naturalistic setting.

The extent of weight changes in depressed patients who use atypical antipsychotics (AAP) as augmentation could not be easily predicted due to weight related symptoms of depression and the interaction with antidepressants which have weight reducing effects.



Patients were treated with either antidepressants augmented with AAP for more than 2 weeks (AAP group, n = 100) or only with antidepressants (non-AAP group, n = 172) during the admission between 2002 and 2006, and the differences in weight were analyzed.



Mean weight gains of AAP group were significantly higher than those of non-AAP group (2.98 +/- 1.87 kg vs. 1.70 +/- 1.85 kg, p = 0.001). When stratified by antidepressants, the significant difference between the two groups was shown among the subjects who had taken serotonin reuptake inhibitors (SSRIs), but not mirtazapine and venlafaxine (3.42 +/- 2.01 kg vs. 1.48 +/- 1.79 kg, p < 0.001). Comparing among different combinations in AAP group showed that subjects treated with SSRIs and olanzapine had the greatest weight gain (4.21 +/- 1.90 kg), significantly higher than that of the other subgroups (p < 0.001).



Our findings suggest that AAP used in patients with depression could severely aggravate preexisting weight-related problems of antidepressants use and the possibility that the combined use with specific antidepressants could have a unique effect on weight by drug-drug interactions.