nils-herrmann/clean_scirepeval huggingface dataset:
An overview of results of world-wide clinical trials with cefadroxil

Cefadroxil, a new semisynthetic oral cephalosporin, is absorbed similarly by fasted and nonfasted subjects, produces sustained serum levels and is eliminated at a relatively slow rate. These pharmacokinetic properties permit less frequent and more convenient dosage scheduling than cephalexin and cephradine and consequently greater patient compliance. Cefadroxil was evaluated for safety in 1051 patients and for efficacy in 1030 patients. Overall it achieved a 91.8% rate of clinical success resulting from 881 complete cures and sixty-five clinical cures. Among 363 patients with respiratory tract infections and 471 patients with genitourinary tract infections, cefadroxil treatment produced 97.5% and 84.5% clinical success, respectively. In the remaining infectious diseases treated, cefadroxil therapy resulted in 99.0% clinical success. Cefadroxil eradicated 87% of 1110 pathogens isolated, among which the most predominant pathogens wereStaphylococcus aureus, β-haemolytic streptococci,Streptococcus pneumoniae, Escherichia coli andProteus mirabilis. Drug-related side-effects were reported in 7.2% of the patients. Cefadroxil, ein neues halbsynthetisches Cephalosporin, wird von nüchternen und nicht nüchternen Probanden annähernd gleich gut resorbiert, es erreicht anhaltende Serumspiegel und wird relativ langsam ausgeschieden. Diese pharmakokinetischen Eigenschaften gestatten ein Dosierungsschema mit weniger häufiger und bequemerer Anwendung als Cephalexin und Cephradin und bringen damit eine günstigere Patienten-Compliance. Cefadroxil wurde bei 1051 Patienten auf seine klinische Sicherheit und bei 1030 Patienten auf seine Wirksamkeit untersucht. Insgesamt wurde eine Rate von 91,8% klinischen Erfolgen erreicht, die sich aus 831 vollständigen Heilungen und fünfundsechzig klinischen Heilungen zusammensetzen. Bei 363 Patienten mit Atemwegsinfektionen und 471 Patienten mit Infektionen des Urogenitaltraktes erzielte die Cefadroxilbehandlung einen klinischen Erfolg von 97,5% beziehungsweise 84,5%. Bei 99% der übrigen behandelten Infektionskrankheiten führte die Cefadroxil-Therapie zu einem klinischen Erfolg. Unter Cefadroxil verschwanden 87% der 1110 isolierten pathogenen Keime, unter denenStaphylococcus aureus, beta-hämolytische Streptokokken,Streptococcus pneumoniae, Escherichia coli undProteus mirabilis am häufigsten waren. Nebenwirkungen im Zusammenhang mit der Medikation wurden bei 7,2% der Patienten festgestellt.
Independent multicenter study of Riata and Riata ST implantable cardioverter-defibrillator leads.

Riata and Riata ST leads (St Jude Medical, Sylmar, CA) are prone to failure. There are no independent multicenter reports regarding Riata or Riata ST lead performance.



To conduct a retrospective multicenter study of Riata and Riata ST leads that were implanted and followed at 7 centers.



The study included adults who received St Jude Medical Riata or Riata ST leads.  Secure leads were obtained from an earlier study.



From 2002 to 2010, 1081 patients received a Riata (n = 774) or Riata ST (n = 307) lead. Follow-up was longer for Riata than Riata ST leads (4.2 ± 2.4 years vs 3.3 ± 1.7 years; P<.0001). During the study, 67 leads failed (6.2%), including 62 of 774 Riata (8.0%) and 5 of 307 Riata ST (1.6%) leads. Forty-seven of 67 lead failures (70.1%) were caused by electrical malfunction, and 20 lead failures (29.9%) were due to externalized conductors (ECs) that were electrically intact. Of 110 leads examined fluoroscopically, ECs were found in 26 of 81 Riata (32%) and 1 of 29 Riata ST (3.4%) leads. Of 26 Riata leads with ECs, 7 (27%) were malfunctioning. Riata leads had lower overall and malfunction free survival compared to Quattro leads (P<.0001), while Riata ST lead survival was not different (P = .422).



The survival of Riata (but not Riata ST) leads was lower than Quattro leads; however, Riata ST leads had significantly shorter follow-up than Riata leads. ECs were common in Riata leads, and more than a quarter of Riata leads that had ECs were malfunctioning. Our observations suggest that systematic fluoroscopic examination of patients with Riata leads is appropriate.
Effect of phase I periodontal therapy on anti-cardiolipin antibodies in patients with acute myocardial infarction associated with chronic periodontitis.

Serum anti-cardiolipin (aCL) antibodies are prevalent in patients with periodontal diseases. These increased aCL concentrations were identified to play a modulating role in cardiovascular diseases. The present study aims to explore the effect of phase I periodontal therapy on immunoglobulin (Ig)M and IgG aCL antibodies in patients with acute myocardial infarction (AMI) associated with chronic periodontitis.



A cross-sectional randomized clinical study was conducted within two groups comprising a sample size of 72 patients (n = 36 each). Group 1 had clinical features of AMI, and group 2 had clinical features of AMI associated with chronic periodontitis. After a thorough clinical and oral examination, the plaque index (PI), gingival index (GI), probing depth (PD), and clinical attachment loss (AL) were recorded. Serum sample collection by venipuncture was done for estimation of serum IgM and IgG aCL concentration by using an enzyme-linked immunosorbent assay method. In group 2, phase I periodontal therapy was performed, and clinical and biochemical parameters were reanalyzed after 1 month.



In group 2, the mean PI, GI, PD, clinical AL, and serum IgM and IgG aCL antibody levels were significantly higher than in group 1 patients. In addition, study results showed significant alterations in concentrations of serum IgM (P = 0.008) and IgG (P <0.001) aCL along with periodontal parameters after phase I periodontal therapy.



The phase I periodontal therapy altered levels of serum IgG and IgM aCL antibodies in patients with AMI associated with chronic periodontitis.
High numbers of mobilized CD34+ cells collected in AML in first remission are associated with high relapse risk irrespective of treatment with autologous peripheral blood SCT or autologous BMT

The faster hematopoietic recovery after autologous peripheral blood SCT (APBSCT) in patients with AML may be offset by an increased relapse risk as compared with autologous BMT (ABMT). The EORTC and GIMEMA Leukemia Groups conducted a trial (AML-10) in which they compared, as second randomization, APBSCT and ABMT in first CR patients without an HLA compatible donor. A total of 292 patients were randomized. The 5-year DFS rate was 41% in the APBSCT arm and 46% in the ABMT arm with a hazard ratio (HR) of 1.17; 95% confidence interval=0.85–1.59; P=0.34. The 5-year cumulative relapse incidence was 56% vs 49% (P=0.26), and the 5-year OS 50% and 55% (P=0.6) in the APBSCT and ABMT groups, respectively. APBSCT was associated with significantly faster recovery of neutrophils and platelets, shorter duration of hospitalization, reduced need of transfusion packed RBC and less days of intravenous antibiotics. In both treatment groups, higher numbers of mobilized CD34+ cells were associated with a significantly higher relapse risk irrespective of the treatment given after the mobilization. Randomization between APBSCT and ABMT did not result in significantly different outcomes in terms of DFS, OS and relapse incidence.
Renal resistive index better predicts the occurrence of acute kidney injury than cystatin C.

The objective of this study was to determine the predictive value of the renal resistive index (RI) and cystatin C values in serum (SCys) and urine (UCys) in the development of acute kidney injury (AKI) in critically ill patients with severe sepsis or polytrauma. This was a prospective, double-center, descriptive study. There were 58 patients with severe sepsis (n= 28) or polytrauma (n = 30). Renal resistive index, SCys, and UCys were measured within 12 h following admission (day 1 [D1]) to the intensive care unit. Renal function was assessed using the AKI network classification: On day 3 (D3), 40 patients were at stage 0 or 1, and 18 were at stage 2 or 3. Patients with AKI stage 2 or 3 had significantly higher RI (0.80 vs. 0.66, P < 0.0001), SCys (1.23 vs. 0.68 mg/L, P = 0.0002), and UCys (3.32 vs. 0.09 mg/L, P = 0.0008). They also had higher Simplified Acute Physiology Score II, arterial lactate level, and intensive care unit mortality. In multivariate analysis, an RI of greater than 0.707 on D1 was the only parameter predictive of the development of AKI stage 2 or 3 on D3 (P = 0.0004). In the subgroup of patients with AKI stage 2 or 3 on D1, RI remained the only parameter associated with persistent AKI on D3 (P = 0.016). In multivariate analysis comparing the predictive value of RI, SCys, and UCys, RI was the only parameter predictive of AKI stage 2 or 3 on D3. Renal resistive index seems to be a promising tool to assess the risk of AKI.
Measuring individual quality of life in patients receiving radiation therapy: the SEIQoL-Questionnaire

Quality of life (QoL) is one of the most important outcomes in cancer care. Although a number of instruments to measure health-related QoL (HRQoL) exist, there are few suitable instruments to measure individual QoL. The best established instrument is the Schedule for the Evaluation of Individual Quality of Life (SEIQoL). The disadvantage of this questionnaire is its use of semi-structured interviews, which are very time-consuming. The purpose of our study was to transform the SEIQoL into an economical instrument that can be used in clinical trials with large samples. We developed the SEIQoL-Questionnaire (SEIQoL-Q) on the basis of the SEIQoL-Direct Weighting (SEIQoL-DW) by transforming the interview guide into a written questionnaire. Patients (N = 1,108) in all three phases of radiation treatment (first consultation, ongoing irradiation, and aftercare) were asked to complete the SEIQoL-Q and the European Organization for Research and Treatment of Cancer QLQ-C30. While the average HRQoL measured by the QLQ-C30 was 55.6, the average SEIQoL-Q index was 59.6. The most important life domain was “physical health,” followed by “emotional well-being” and “family.” Patients attributed the highest level of satisfaction to “home/housing,” followed by “family” and “partnership.” Male patients were shown to have a significantly better QoL than females. The SEIQoL-Q index correlates moderately with the QLQ-C30 functioning scale “global quality of life” [r = .42 (p < .001)]. According to our findings, the SEIQoL-Q appears to be a feasible and economical instrument for use in quantitative research among cancer patients in different stages of their disease.
Initial Experience of a Second-Generation Self-Expanding Transcatheter Aortic Valve: The UK & Ireland Evolut R Implanters' Registry.

The authors present the UK and Irish real-world learning curve experience of the Evolut R transcatheter heart valve.



The Evolut R is a self-expanding, repositionable, and fully recapturable second-generation transcatheter heart valve with several novel design features to improve outcomes and reduce complications.



Clinical, procedural, and 30-day outcome data were prospectively collected for the first 264 patients to receive the Evolut R valve in the United Kingdom and Ireland.



A total of 264 consecutive Evolut R implantations were performed across 9 centers. The mean age was 81.1 ± 7.8 years, and the mean logistic European System for Cardiac Operative Risk Evaluation score was 19.9 ± 13.7%. Procedural indications included aortic stenosis (72.0%), mixed aortic valve disease (17.4%), and failing aortic valve bioprostheses (10.6%). Conscious sedation was used in 39.8% of patients and transfemoral access in 93.6%. The procedural success rate was 91.3%, and paravalvular leak immediately after implantation was mild or less in 92.3%. Major complications were rare: cardiac tamponade in 0.4%, conversion to sternotomy in 0.8%, annular rupture in 0.0%, coronary occlusion in 0.8%, major vascular in 5.3%, acute kidney injury in 6.1%, new permanent pacemaker implantation in 14.7%, and procedure-related death in 0.0%. At 30-day follow-up, survival was 97.7%, paravalvular leak was mild or less in 92.3%, and the stroke rate was 3.8%.



This registry represents the largest published real-world experience of the Evolut R valve. The procedural success rate was high and safety was excellent, comparable with previous studies of the Evolut R valve and other second-generation devices. The low rate of complications represents an improvement on first-generation devices.
Randomized comparison of adjunctive cilostazol versus high maintenance dose clopidogrel in patients with high post-treatment platelet reactivity: results of the ACCEL-RESISTANCE (Adjunctive Cilostazol Versus High Maintenance Dose Clopidogrel in Patients With Clopidogrel Resistance) randomized study.

The purpose of this study was to determine the impact of adjunctive cilostazol in patients with high post-treatment platelet reactivity (HPPR) undergoing coronary stenting.



Although addition of cilostazol to dual antiplatelet therapy enhances adenosine diphosphate (ADP)-induced platelet inhibition, it is unknown whether adjunctive cilostazol can reduce HPPR.



Sixty patients with HPPR after a 300-mg loading dose of clopidogrel were enrolled. HPPR was defined as maximal platelet aggregation (Agg(max)) >50% with 5 micromol/l ADP. Patients were randomly assigned to receive either adjunctive cilostazol (triple group; n = 30) or high maintenance dose (MD) clopidogrel (high-MD group; n = 30). Platelet function was assessed at baseline and after 30 days with conventional aggregometry and the VerifyNow assay.



Baseline platelet function measurements were similar in both groups. After 30 days, significantly fewer patients in the triple versus high-MD group had HPPR (3.3% vs. 26.7%, p = 0.012). Percent inhibitions of 5 micromol/l ADP-induced Agg(max) and late platelet aggregation (Agg(late)) were significantly greater in the triple versus high-MD group (51.1 +/- 22.5% vs. 28.0 +/- 18.5%, p < 0.001, and 70.9 +/- 27.3% vs. 45.3 +/- 23.4%, p < 0.001, respectively). Percent inhibitions of 20 micromol/l ADP-induced Agg(max) and Agg(late) were consistently greater in the triple versus high-MD group. Percent change of P2Y12 reaction units demonstrated a higher antiplatelet effect in the triple versus high-MD group (39.6 +/- 24.1% vs. 23.1 +/- 29.9%, p = 0.022).



Adjunctive cilostazol reduces the rate of HPPR and intensifies platelet inhibition as compared with a high-MD clopidogrel of 150 mg/day.
Renal and cardiac effects of antihypertensive treatment with ramipril versus metoprolol in autosomal dominant polycystic kidney disease.

Autosomal dominant polycystic kidney disease (ADPKD) affects ∼12.5 million people worldwide. Forty percent of patients are diagnosed by 45 years of age. ADPKD is the fourth most common cause for end-stage renal disease (ESRD) worldwide and this disease accounts for 5–10% of renal transplant recipients . Therefore, any therapeutic modality that can slow down the natural course history of this disease would have a significant impact on patients’ well-being and would be financially cost-effective. The manuscript by Zeltner et al. in this issue attempts to determine if there is a difference between an angiotensinconverting enzyme (ACE) inhibitor (ramipril) and a beta blocker (metoprolol) when employing first-line therapy in ADPKD patients with hypertension. The study has a number of limitations; some of them recognized by the authors that could influence the conclusion are noted as follows:
The French-Canadian validation of a disease-specific, patient-reported outcome measure for lupus.

The objective of this paper is to perform the cross-cultural validation of the French version of the LupusPRO, a disease-targeted patient-reported outcome measure, among systemic lupus erythematosus (SLE) patients in Canada.



The French version of the LupusPRO and the MOS SF-36 were administered; demographic, clinical and serological characteristics were obtained. Disease activity (SELENA-SLEDAI and the Lupus Foundation of America definition of flare) and damage (SLICC/ACR SDI) were assessed. Physician disease activity and damage assessments were ascertained using visual analog scales. Internal consistency reliability (ICR), test-retest reliability (TRT), convergent and discriminant validity (against corresponding domains of the SF-36), criterion validity (against disease activity, damage or health status) and known group validity were tested.



A total of 99 French-Canadian SLE patients participated (97% women, mean (SD) age 45.2 (14.5) years). The median (IQR) SELENA-SLEDAI and SDI were 3.5 (6.0) and 1.0 (2.0), respectively. The ICR of the LupusPRO domains ranged from 0.81 to 0.93 (except for lupus symptoms, procreation and coping), while TRT ranged from 0.72 to 0.95. Convergent and discriminant validity, criterion validity and known group validity against disease activity, damage and health status measures were observed. Confirmatory factor analysis showed a good fit.



The LupusPRO has fair psychometric properties among French-Canadian patients with SLE.
Effect of amlodipine, quinapril, and losartan on pulse wave velocity and plasma collagen markers in patients with mild-to-moderate arterial hypertension.

Carotid-femoral pulse wave velocity (PWV) is a prognostic factor in arterial hypertension. Modification of PWV, apart from blood pressure (BP) lowering seems to be important in the evaluation of antihypertensive drugs. One of the underlying causes arterial stiffening is arterial wall fibrosis. Plasma collagen I metabolites: carboxy (PICP) and amino (PINP) propeptides are considered as a valuable approach in the assessment of arterial fibrosis. The purpose of the present study was to compare changes in BP, PWV, plasma aldosterone, and collagen metabolites after treatment with amlodipine, quinapril, and losartan.



One hundred eighteen patients with mild-to-moderate essential arterial hypertension were randomized to treatment with 10 mg/d of amlodipine (group 1), 20 mg/d of quinapril (group 2), or 2 x 50 mg/d of losartan (group 3). At baseline, and after 3 and 6 months analysis of variance was performed to compare changes in BP, PWV, aldosterone, PICP, and PINP among subjects with adequate BP control on monotherapy (group 1, n = 38, group 2, n = 37, group 3, n = 24).



Blood pressure decreased equally in all groups. Among patients with comparable BP values on monotherapy, only quinapril-treated patients showed a significant decrease in PWV, aldosterone, and PICP as compared with baseline values. Multiple regression analysis showed that PWV was significantly affected by: age (beta = 0.36; P =.021), systolic BP (beta = 0.45; P =.014), and PICP (beta = 0.27; P =.038).



In hypertensive subjects PWV depends on age, systolic BP, and collagen synthesis. Of the three drugs with comparable BP-lowering efficacy only quinapril significantly decreases PWV, plasma aldosterone, and PICP.
Painless indirect argon laser in high risk proliferative diabetic retinopathy.

Proliferative retinopathy is an important cause of vision loss in diabetic patients. Incomplete panretinal photocoagulation (PRP) can lead to recurrent proliferation of new vessels.



We retrospectively analysed the outcome of patients with high risk proliferative diabetic retinopathy (PDR) previously treated with slit lamp PRP who underwent indirect fill in argon laser treatment with scleral indentation under anesthesia for persistent neovascular proliferation.



Seventeen eyes of ten patients were included. The mean age at diabetes onset was 17.3 years SD 16.2 (range 2-44). All patients reported long standing poor glycemic control (mean HbA1c: 8.5% SD 1.3 range 5.9-10.2). The area of retinal ischemia decreased significantly from 15±7.5 disk areas (DA) before fill-in laser to 3.2±4.2 DA after fill-in laser (p=0.001). The new vessels also regressed significantly after laser treatment 8.6±6.1 DA before treatment versus 6.5±6.4 DA after laser treatment, (p=0.044). Quiescent PDR was reached in 10 eyes (58.8%) at the last visit.



Fill-in indirect argon laser under general anesthesia should be considered to achieve further new vessels regression in high risk PDR patients. Scleral indentation and absence of pain may allow for more extensive laser application.
Effects of low and high doses of atorvastatin on arterial compliance.

At the beginning of atherosclerosis before evidence of morphological lesions or plaques, vascular distensibility or arterial compliance decreased gradually. This endothelial dysfunction is regarded as an early feature of atherosclerosis. In a randomized, double-blind study design, group 1 (12 patients; 7 males, 5 females) with serum LDL-C levels higher than 170 mg/dL and without any other risk factor for atherosclerosis received three months of 20 mg/day atorvastatin treatment while group 11 (8 males, 4 females) with the same characteristics received 80 mg/day. Baseline and posttreatment serum lipid fractions and arterial compliance were measured. Arterial compliance was measured noninvasively in the left common carotid artery with color Doppler ultrasound. Atorvastatin reduced total cholesterol (TC), LDL-C, and triglyceride levels by 32% (P < 0.001), 40.8% (P < 0.001), and 19% (P < 0.001), respectively, and increased HDL-C by 6.9%, (P = 0.002) in the first group. In the second group these reductions were 38.5% (P < 0.001), 46.2% (P < 0.001), and 26.78% (P < 0.001), respectively, and the increase in HDL was 7.8% (P = 0.03). It was observed that the decrease in serum TC, LDL-C and triglyceride levels were significantly higher in the second group than the first group. With atorvastatin, the distensibility coefficient (DC) and compliance coefficient (CC) increased from 18.7 +/- 3.4 to 21.3 +/- 2.9 10(-3) x kPa(-1) (P < 0.001) and from 0.69 +/- 0.05 to 0.77 +/- 0.03 mm2 x kPa(-1) (P < 0.001) in the first group while they changed from 18.3 +/- 3.6 to 21.9 +/- 3.0 10(-3) x kPa(-1) (P < 0.001) and from 0.70 +/- 0.04 to 0.81 +/- 0.01 mm2 x kPa(-1) (P < 0.001) respectively, in the second group. DC and CC increased in both groups, but the differences between the groups were not significant. High doses of atorvastatin reduce blood lipid levels more than conventional doses, however, the change in compliance is not dose-dependent. As endothelial dysfunction is regarded as an early feature of atherosclerosis, there would be no need to administer aggressive doses in a patient without any risk factors other than hyperlipidemia.
Multiple infusions of CD20-targeted T cells and low-dose IL-2 after SCT for high-risk non-Hodgkin's lymphoma: A pilot study

A pilot phase I clinical trial involving 15 infusions of anti-CD3 × anti-CD20 bispecific Ab (CD20Bi)-armed anti-CD3-activated T cells (aATC) and low-dose IL-2 was conducted in three non-Hodgkin’s lymphoma (NHL) patients (two high-risk and one refractory) after autologous SCT. The feasibility of T-cell expansion, safety of aATC infusions, cytotoxic immune responses and trafficking of aATC were evaluated. Three NHL patients received 15 infusions of 5 × 109 aATC (three infusions/week for 3 weeks and one infusion/week for 6 weeks) between days 1 and 65 after SCT with IL-2. There were no dose-limiting toxicities. Chills, fever, hypotension and malaise were the common side effects. Engraftment was delayed in one patient with a low stem cell dose. CD20Bi aATC infusions induced specific cytotoxicity directed at lymphoma targets. Endogenous peripheral blood mononuclear cells from two patients mediated anti-lymphoma cytotoxicity above preSCT background (P<0.001). 111In labeled aATC trafficked to the lungs at 1 h and accumulated in the liver and bone marrow after 24 h. aATC infusions given over 69 days in combination with IL-2 were safe, did not inhibit engraftment, and induced endogenous cytotoxic responses directed at lymphoma targets.