nils-herrmann/clean_scirepeval huggingface dataset:
Atazanavir in patients with persistent viral replication despite HAART: results from the French prospective NADIS cohort.

To assess virological efficacy of a ritonavir-boosted atazanavir (ATV/r)-containing regimen in patients with persistent viral replication despite HAART.



Prospective cohort of French HIV-infected patients. Patients were included if pretreated and viral load (VL) >400 copies/mL at the time of ATV/r first prescription (baseline). Demographic and epidemiologic data, therapeutic history, and clinical and biological values at baseline and during follow-up were analyzed. Primary endpoint was failure of the regimen defined as either VL>400 copies/mL at Week 24 or treatment interruption before Week 24. Multivariate analysis was performed of baseline characteristics related with treatment failure.



There were 424 patients with available data. Primary endpoint was met by 36%: 24% VL>400 copies/mL and 12% treatment interruption. Treatment interruption due to drug-related toxicity was significantly more frequent in women (20.5% vs. 8.8%, p= .001). Female gender (adjusted odds ratio [OR]=1.91), previous use of lopinavir (LPV; OR=2.76), number of new drugs and of active drugs in the regimen (OR=0.48 and 0.3, respectively), and baseline VL (OR=1.75) were independently related with treatment failure.



ATV/r-containing regimens, because of low pill burden and good tolerance, can be a useful strategy as long as the patients did not suffer previous LPV failures. The issue of gender deserves further studies in larger populations.
Biomechanical Stability of Juvidur and Bone Models on Osteosyntesic Materials

Artificial models can be useful at approximate and qualitative research, which should give the preliminary results. Artificial models are usually made of photo-elastic plastic e.g.. juvidur, araldite in the three-dimensional contour shape of the bone. Anatomical preparations consist of the same heterogeneous, structural materials with extremely anisotropic and unequal highly elastic characteristics, which are embedded in a complex organic structure.


THE AIM OF THE STUDY
Examine the budget voltage and deformation of: dynamic compression plate (DCP), locking compression plate (LCP), Mitkovic internal fixator (MIF), Locked intramedullary nailing (LIN) on the compressive and bending forces on juvidur and veal bone models and compared the results of these two methods (juvidur, veal bone).



For the experimental study were used geometrically identical, anatomically shaped models of Juvidur and veal bones diameter of 30 mm and a length of 100 mm. Static tests were performed with SHIMADZU AGS-X testing machine, where the force of pressure (compression) increased from 0 N to 500 N, and then conducted relief. Bending forces grew from 0 N to 250 N, after which came into sharp relief.



On models of juvidur and veal bones studies have confirmed that uniform stability at the site of the fracture MIF with a coefficient ranking KMIF=0,1971, KLIN=0,2704, KDCP=0,2727 i KLCP=0,5821.



On models of juvidur and veal bones working with Shimadzu AGS-X testing machine is best demonstrated MIF with a coefficient of 0.1971.
Association of the variants in the BUD13-ZNF259 genes and the risk of hyperlipidaemia

The single nucleotide polymorphisms (SNPs) in the BUD13 homolog (BUD13) and zinc finger protein 259 (ZNF259) genes have been associated with one or more serum lipid traits in the European populations. However, little is known about such association in the Chinese populations. Our objectives were to determine the association of the BUD13/ZNF259 SNPs and their haplotypes with hypercholesterolaemia (HCH)/hypertriglyceridaemia (HTG) and to identify the possible gene-gene interactions among these SNPs. Genotyping of 6 SNPs was performed in 634 hyperlipidaemic and 547 normolipidaemic participants. The ZNF259 rs2075290, ZNF259 rs964184 and BUD13 rs10790162 SNPs were significantly associated with serum lipid levels in both HCH and non-HCH populations (P < 0.008-0.001). On single locus analysis, only BUD13 rs10790162 was associated with HCH (OR: 2.23, 95% CI: 1.05, 4.75, P = 0.015). The G-G-A-A-C-C haplotype, carrying rs964184-G-allele, was associated with increased risk of HCH (OR: 1.35, 95% CI: 1.10, 1.66, P = 0.005) and HTG (OR: 1.75, 95% CI: 1.39, 2.21, P = 0.000). The A-C-G-G-C-C and A-C-A-G-T-C haplotypes, carrying rs964184-C-allele, were associated with reduced risk of HCH (OR: 0.77, 95% CI: 0.61, 0.99, P = 0.039 and OR: 0.66, 95% CI: 0.47, 0.94, P = 0.021 respectively). On multifactor dimensionality reduction analyses, the two- to three-locus models showed a significant association with HCH and HTG (P < 0.01-0.001). The BUD13/ZNF259 SNPs, which were significant in the European populations, are also replicable in the Southern Chinese population. Moreover, inter-locus interactions may exist among these SNPs. However, further functional studies are required to clarify how these SNPs and genes actually affect the serum lipid levels.
Incidence of left atrial abnormalities under treatment with dabigatran, rivaroxaban, and vitamin K antagonists

Non-vitamin K antagonist oral anticoagulants (NOACs) such as dabigatran or rivaroxaban are alternatives to vitamin K antagonists (VKAs) for prevention of stroke and systemic embolism in patients with atrial fibrillation (AF) and atrial flutter (AFL). Incidences of risk factors for left atrium (LA) and left atrial appendage (LAA) thrombus formation, such as dense spontaneous echo contrast (SEC), low LAA velocity (LAAV) <20 cm/s under treatment with dabigatran and rivaroxaban in comparison with VKAs are unknown.



We studied 306 patients with AF (94 %) and AFL (6 %) undergoing transesophageal echocardiography. Patients received VKAs (n = 138), dabigatran (n = 68), or rivaroxaban (n = 100) for at least 3 weeks prior to investigation. Time in therapeutic range was 67 % for VKA. Mean CHADS2 score and CHA2DS2-VASc score were 1.3 and 2.5, respectively. Left atrial abnormality was defined as either dense SEC, low LAAV <20 cm/s, or thrombus.



Any LA abnormality occurred in 9, 3, and 5 % of patients receiving VKA, dabigatran, and rivaroxaban, respectively. The most frequent abnormality was LAA thrombus (VKA: 4 %, dabigatran: 0 %, rivaroxaban: 2 %) and low LAAV of less than 20 cm/s (VKA: 4 %, dabigatran: 1 %, rivaroxaban: 1 %), followed by dense SEC (VKA: 2 %, dabigatran: 1 %, rivaroxaban: 2 %). Results of uni- and multivariate analyses revealed a numerically lower but not significantly different frequency of any LA abnormality under dabigatran (OR 0.4, 95 % Cl 0.08 - 1.88, p = 0.25) and rivaroxaban (OR 0.65, 95 % Cl 0.22 - 1.98, p = 0.45) compared to VKA.



With respect to the incidence of LA abnormalities, dabigatran and rivaroxaban are not inferior to VKA.
Randomized trial of liberal versus restrictive guidelines for red blood cell transfusion in preterm infants.

Although many centers have introduced more restrictive transfusion policies for preterm infants in recent years, the benefits and adverse consequences of allowing lower hematocrit levels have not been systematically evaluated. The objective of this study was to determine if restrictive guidelines for red blood cell (RBC) transfusions for preterm infants can reduce the number of transfusions without adverse consequences.



We enrolled 100 hospitalized preterm infants with birth weights of 500 to 1300 g into a randomized clinical trial comparing 2 levels of hematocrit threshold for RBC transfusion.



The infants were assigned randomly to either the liberal- or the restrictive-transfusion group. For each group, transfusions were given only when the hematocrit level fell below the assigned value. In each group, the transfusion threshold levels decreased with improving clinical status.



We recorded the number of transfusions, the number of donor exposures, and various clinical and physiologic outcomes.



Infants in the liberal-transfusion group received more RBC transfusions (5.2 +/- 4.5 [mean +/- SD] vs 3.3 +/- 2.9 in the restrictive-transfusion group). However, the number of donors to whom the infants were exposed was not significantly different (2.8 +/- 2.5 vs 2.2 +/- 2.0). There was no difference between the groups in the percentage of infants who avoided transfusions altogether (12% in the liberal-transfusion group versus 10% in the restrictive-transfusion group). Infants in the restrictive-transfusion group were more likely to have intraparenchymal brain hemorrhage or periventricular leukomalacia, and they had more frequent episodes of apnea, including both mild and severe episodes.



Although both transfusion programs were well tolerated, our finding of more frequent major adverse neurologic events in the restrictive RBC-transfusion group suggests that the practice of restrictive transfusions may be harmful to preterm infants.
Efficacy and safety of once-daily fluticasone furoate/vilanterol (100/25 mcg) versus twice-daily fluticasone propionate/salmeterol (250/50 mcg) in COPD patients.

Fluticasone furoate/vilanterol (FF/VI) is an inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA), recently approved as once-daily maintenance therapy for COPD. We compared the lung function effects of FF/VI with those of twice-daily fluticasone propionate/salmeterol (FP/SAL).



Three 12 week studies comparing FF/VI and FP/SAL were conducted. Patients aged ≥40 years with moderate-to-very severe COPD were randomized to receive double-blind, double-dummy FF/VI 100/25 mcg once-daily, or FP/SAL 250/50 mcg twice-daily for 12 weeks following a 2 week placebo run-in period. The primary endpoint of each study was change from baseline trough in 0-24 h weighted mean FEV(1) (wmFEV(1)) on Day 84. Safety was also assessed.



In Study 1 (HZC113109) (intent-to-treat n: FF/VI = 260; FP/SAL = 259), the increase from baseline in 0-24 h wmFEV(1) was significantly greater with FF/VI than FP/SAL (Δ80 mL, P < 0.001). In Study 2 (HZC112352) (intent-to-treat n: FF/VI = 259; FP/SAL = 252) and Study 3 (RLV116974) (intent-to-treat n: FF/VI = 412; FP/SAL = 416), the increase from baseline in 0-24 h wmFEV(1) was not significantly greater with FF/VI than FP/SAL (Δ29 mL, P = 0.267; Δ25 mL, P = 0.137). The treatment difference was statistically but not clinically significant in a pooled analysis (Δ41 mL, P < 0.001). Pooled adverse events (FF/VI 27%; FP/SAL 28%) and serious adverse events (FF/VI 2%; FP/SAL 3%) were similar between treatments.



Our data suggest that once-daily FF/VI 100/25 mcg provides FEV(1) improvement in COPD that is at least comparable with that conferred by twice-daily FP/SAL 250/50 mcg, although interpretation is limited by differences in individual study outcomes. The safety profiles of FF/VI 100/25 mcg and FP/SAL 250/50 mcg are similar.
A phase I clinical trial of tiopronin, a putative neuroprotective agent, in aneurysmal subarachnoid hemorrhage.

The neurotoxic aldehyde 3-aminopropanal (3-AP) contributes to brain injury following cerebral ischemia. Tiopronin (N-2-mercaptopropionyl-glycine[N-2-MPG]) is a US Food and Drug Administration (FDA)-approved drug for the treatment of cystinuria and a putative neuroprotective agent that has been shown to bind and neutralize 3-AP and reduce infarct volumes.



The objective of this trial was to establish the safety of tiopronin administration in patients with aneurysmal subarachnoid hemorrhage (aSAH) in preparation for further trials of its efficacy as a neuroprotective agent in this disease process.



This Phase I dose-escalation trial enrolled three-patient cohorts using a conventional "3+3" study design. Tiopronin dose began at 1 g/d until aSAH Day 14. Each subsequent cohort received a dose of tiopronin based on predetermined guidelines. A maximum dose of 3 g/d was selected, because this is the maximum FDA-approved dose for long-term cystinuria treatment. Subjects were monitored for known side effects of tiopronin.



Nine patients were enrolled, the minimum number required based on the study design. None of these patients experienced serious side effects attributable to tiopronin, and no adverse events were noted that could not be attributed to the pathophysiology of aSAH.



The administration of 3 g/d of tiopronin following aSAH for up to 14 days appears to be safe and without the side effects associated with long-term use. Plans for a randomized, placebo-controlled Phase II trial of tiopronin for neuroprotection following aSAH are underway.
Triple antiviral therapy in hepatitis C virus infection with or without mixed cryoglobulinaemia: a prospective, controlled pilot study.

Mixed cryoglobulinaemia is strongly related to hepatitis C virus infection. Treatment with peg-interferon and ribavirin has been indicated as first-line therapy for mild/moderate hepatitis C virus-related mixed cryoglobulinaemia.



To evaluate the safety and efficacy of triple boceprevir-based antiviral therapy in patients with or without mixed cryoglobulinaemia previously treated with peg-interferon and ribavirin, and with advanced liver disease.



Thirty-five hepatitis C virus-positive patients (17 with asymptomatic mixed cryoglobulinaemia, 5 with symptomatic mixed cryoglobulinaemia, and 11 without mixed cryoglobulinaemia) were treated with triple boceprevir-based antiviral therapy.



In 19/22 cryoglobulinaemic subjects (86%), the addition of boceprevir induced cryocrit disappearance. Cryocrit behaviour was related to virological response, with improvement of symptoms upon undetectable viraemia and reappearance after virological breakthrough. The rate of sustained virological response was lower in cryoglobulinaemic patients than in patients without mixed cryoglobulinaemia (23.8% vs 70% respectively, p=0.01).



Boceprevir-based therapy was safe and effective in cryoglobulinaemic patients. The correlation between direct inhibition of hepatitis C virus replication and clinical improvement in mixed cryoglobulinaemic patients is definitive proof of the key pathogenetic role played by viral replication. Further studies are needed to confirm and clarify the reduced virological response in patients with mixed cryoglobulinaemia.
Effects of two types of training on pulmonary and cardiac responses to moderate exercise in patients with COPD.

The effects of two 8-week programmes of exercise reconditioning on the time constants (tau) of the pulmonary gas exchange, ventilatory and heart rate responses to moderate intensity exercise in patients with chronic obstructive pulmonary disease (COPD) were studied. Thirty-five subjects (mean+/-SD 64+/-5 yrs; forced expiratory volume in one second (FEV1) 1.09+/-0.17 L; 41+/-6.2% predicted) were randomly assigned either to supervised (s) training on a treadmill, 4 days x week(-1) (group S; n=21) or self-monitored (SM) walking 3 or 4 km in 1 h 4 days x week(-l) (group SM; n=20). The different levels of supervision resulted in a different estimated intensity of training (35+/-10 W in the SM group and 70+/-22 W in the S group). The kinetics were evaluated with a constant-load exercise test on a cycle-ergometer at a work rate corresponding to 80% the highest oxygen consumption (V'O2) that can be achieved without blood lactic acidosis (V'O2,LAT) or 50% of V'O2,max, if maximum oxygen consumption V'O2,LAT was not found. Mean endurance time at a work rate equivalent to 70% of the pretraining V'O2,max increased by 493+/-281 s in the S group and 254+/-283 s in the SM group (p<0.001). Mean tauV'O2 decreased from 83+/-17 s to 67+/-11 s (p<0.0001) in the S group and from 84+/-12 to 79+/-16 (p=0.04) in the SM group. Mean tau for carbon dioxide output minute ventilation and heart rate were also speeded after training, again more markedly in the S group. In the S group there was a significant correlation between the decrease in tauV'O2 and the increase in endurance time (r=-0.56, SEM=0.21). It is concluded that training speeds the kinetic response of oxygen consumption, carbon dioxide production, minute ventilation and heart rate to moderate exercise and that the effect is greater after supervised, more intense training.
Developing a Community-Based Tailored Exercise Program for People With Severe and Persistent Mental Illness.

People with severe and persistent mental illness (SPMI) are at a greater risk of medical issues compared with the general population. Exercise has a positive effect on physical and mental health outcomes among this population in community settings.



To describe community-based participatory research (CBPR) methods used to tailor an exercise program among people with SPMI, demonstrate its impact, and present lessons learned for future research.



The partnership developed a project to explore the feasibility of implementing a physical activity program at a community agency among clients with SPMI.



Data showed improved trends in mood, social support, and physical and mental health outcomes. Facilitators and barriers must be carefully considered for recruitment and retention.



A gender-specific, group-based, tailored exercise intervention developed through collaboration with a community agency serving people with SPMI using CBPR methods is feasible.
Comparison of albuterol delivered by a metered dose inhaler with spacer versus a nebulizer in children with mild acute asthma.

In children with mild acute asthma, to compare treatment with a single dose of albuterol delivered by a metered dose inhaler (MDI) with a spacer in either a weight-adjusted high dose or a standard low-dose regimen with delivery by a nebulizer.



In this randomized double-blind trial set in an emergency department, 90 children between 5 and 17 years of age with a baseline forced expiratory volume in 1 second (FEV1 ) between 50% and 79% of predicted value were treated with a single dose of albuterol, either 6 to 10 puffs (n = 30) or 2 puffs (n = 30) with an MDI with spacer or 0.15 mg/kg with a nebulizer (n = 30).



No significant differences were seen between treatment groups in the degree of improvement in percent predicted FEV1 (P =.12), clinical score, respiratory rate, or O2 saturation. However, the nebulizer group had a significantly greater change in heart rate (P =.0001). Our study had 93% power to detect a mean difference in percent predicted FEV1 of 8 between the treatment groups.



In children with mild acute asthma, treatment with 2 puffs of albuterol by an MDI with spacer is just as clinically beneficial as treatment with higher doses delivered by an MDI or by a nebulizer.
Comparison of prone positioning and high-frequency oscillatory ventilation in patients with acute respiratory distress syndrome.

Both prone position and high-frequency oscillatory ventilation (HFOV) have the potential to facilitate lung recruitment, and their combined use could thus be synergetic on gas exchange. Keeping the lung open could also potentially be lung protective. The aim of this study was to compare physiologic and proinflammatory effects of HFOV, prone positioning, or their combination in severe acute respiratory distress syndrome (ARDS).


 Prospective, comparative randomized study.



A medical intensive care unit.



Thirty-nine ARDS patients with a Pao2/Fio2 ratio <150 mm Hg at positive end-expiratory pressure > or =5 cm H2O.



After 12 hrs on conventional lung-protective mechanical ventilation (tidal volume 6 mL/kg of ideal body weight, plateau pressure not exceeding the upper inflection point, and a maximum of 35 cm H2O; supine-CV), 39 patients were randomized to receive one of the following 12-hr periods: conventional lung-protective mechanical ventilation in prone position (prone-CV), HFOV in supine position (supine-HFOV), or HFOV in prone position (prone-HFOV).



Prone-CV (from 138 +/- 58 mm Hg to 217 +/- 110 mm Hg, p < .0001) and prone-HFOV (from 126 +/- 40 mm Hg to 227 +/- 64 mm Hg, p < 0.0001) improved the Pao2/Fio2 ratio whereas supine-HFOV did not alter the Pao2/Fio2 ratio (from 134 +/- 57 mm Hg to 138 +/- 48 mm Hg). The oxygenation index ({mean airway pressure x Fio2 x 100}/Pao2) decreased in the prone-CV and prone-HFOV groups and was lower than in the supine-HFOV group. Interleukin-8 increased significantly in the bronchoalveolar lavage fluid (BALF) in supine-HFOV and prone-HFOV groups compared with prone-CV and supine-CV. Neutrophil counts were higher in the supine-HFOV group than in the prone-CV group.



Although HFOV in the supine position does not improve oxygenation or lung inflammation, the prone position increases oxygenation and reduces lung inflammation in ARDS patients. Prone-HFOV produced similar improvement in oxygenation like prone-CV but was associated with higher BALF indexes of inflammation. In contrast, supine-HFOV did not improve gas exchange and was associated with enhanced lung inflammation.
Prescribing pattern of antihypertensive drugs in primary care units in Turkey: results from the TURKSAHA study

The prescribing pattern of drugs used for treating hypertension changes over time in response to changes in recommended guidelines and innovations in drug formulations, among others. In addition, the classes of antihypertensive drugs used vary among the countries. The aim of this study was to investigate the practice of antihypertensive medications in primary care units in Turkey. TURKSAHA is a cross-sectional screening study conducted in 1000 primary care units considered to be representative of primary care in Turkey, with the purpose of defining the demographic characteristics, clinical features, rate of blood pressure control achieved and the antihypertensive drugs prescribed for the hypertensive patients treated in these centers. In this analysis, we investigated the agents used in the treatment regimen. Of the 16,270 patients considered to be eligible for inclusion in the study, 15,187 (93.3%) were on an antihypertensive treatment, and 1083 (6.7%) were receiving no treatment. Patients who received treatment but whose antihypertensive medication was not specified (2290 patients) were subsequently excluded, and the trial was carried out with the remaining 12,897 patients. The mean age of the patients was 60 ± 11 years (60.2% female). Of the 12,897 patients, 75.7% were receiving monotherapy, 19.7% two drugs, 4.1% three drugs and 0.5% four or more drugs. The rate of successful blood pressure control (<140/90 mmHg; for diabetics <130/80 mm Hg) in relation to the number of drugs received was 26.3, 25.9, 24.5 and 26.2%, respectively. Among the patients receiving monotherapy, the most frequently used antihypertensive drug class was angiotensin-converting enzyme inhibitors (30.1%), followed by β-blockers (20.6%), calcium-channel blockers (17.9%), diuretics (15.4%) and angiotensin-receptor blockers (14%). As in other European countries, the rate of successful blood pressure control was low among hypertensive patients receiving treatment, and despite the inadequacy of monotherapy to control blood pressure, many of the patients continued this treatment regimen. Consistent with the global trend, the most frequently prescribed anti-hypertensives were angiotensin blockers.