nils-herrmann/clean_scirepeval huggingface dataset:
Impact of a modified directly administered antiretroviral treatment intervention on virological outcome in HIV-infected patients treated in Burkina Faso and Mali.

This study explores whether viral load measurements can be used in resource-limited settings to target those in need of adherence assistance. It was hypothesized that high plasma viral loads (pVLs) (>/=500 HIV-1 RNA copies/mL) were the result of poor antiretroviral therapy adherence and amenable to improvement with adherence assistance.



A single-arm, multicentre pilot study was conducted from November 2003 to March 2004 on 606 treatment-experienced patients who had initiated an antiretroviral regimen in Mali and Burkina Faso >/=6 months before study enrolment. In these patients, those whose pVL was >/=500 copies/mL were offered 1 month of modified directly administered antiretroviral treatment (mDAART) with weekly follow-up visits from pharmacists or adherence counsellors.



An adherence questionnaire was given to all cohort patients and viral load was used to screen for patients with >/=500 copies/mL. mDAART participants included cohort patients with >/=500 copies/mL, who completed the adherence questionnaire. Genotypic analyses were conducted on samples taken prior to and after the intervention. The intervention was considered effective when there was a decrease of >/=1 log(10) in pVL.



mDAART was effective in over one-third of the intervention participants, while in two-thirds no decrease in pVL was observed. The majority of mDAART participants had major resistance mutations.



pVL measurement was useful to identify patients who needed adherence assistance. However, because it was performed >/=6 months after starting treatment, mDAART came too late for most participants, as they had already developed important resistance mutations that might have been avoided with better laboratory monitoring.
A pilot study of protracted topotecan dosing using a pharmacokinetically guided dosing approach in children with solid tumors.

To assess the use of a pharmacokinetically guided topotecan strategy and evaluate the toxicity of protracted i.v. topotecan in children with recurrent solid tumors.



Fifteen children with measurable relapsed or refractory solid tumors received topotecan i.v. over 30 min 5 days a week for two consecutive weeks. Doses were individualized based on the patient's topotecan systemic clearance to attain a single day topotecan lactone area under the plasma concentration time curve (AUC) of 120-180 ng/ml x h (cohort 1) or 80-120 ng/ml x h (cohort 2). Clinical responses and toxicity were assessed by standard criteria.



Twenty-nine courses of topotecan were administered, 11 in cohort 1 and 18 in cohort 2. The median topotecan dosages required to achieve the target AUCs for cohorts 1 and 2 were 4 mg/m(2) (range, 2.6-6) and 3 mg/m(2) (range, 2.6-4.2), respectively. The intersubject variance for topotecan clearance exceeded the intrasubject variance by 2-fold. With the pharmacokinetic targeting approach, we observed that 78% (46 of 59) of the measured AUC values were within the target range. The median number of days to an absolute neutrophil count >/=500/mm(3) was similar between the two cohorts; however, febrile neutropenia and serious infections limited our ability to deliver drug dosages needed to secure the higher systemic exposure (cohort 1). Five partial responses were observed.



Protracted topotecan dosing using a pharmacokinetic strategy was possible in this heavily pretreated group of children.
Ethnicity and pathways to care during first episode psychosis: the role of cultural illness attributions

Studies demonstrate ethnic variations in pathways to care during first episode psychosis (FEP). There are no extant studies, however, that have statistically examined the influence of culturally mediated illness attributions on these variations.



We conducted an observational study of 123 (45 White; 35 Black; 43 Asian) patients recruited over a two-year period from an Early Intervention Service (EIS) in Birmingham, UK. Sociodemographic factors (age; sex; education; country of birth; religious practice; marital status; living alone), duration of untreated psychosis (DUP), service contacts (general practitioner; emergency services; faith-based; compulsory detention; criminal justice) and illness attributions ("individual;" "natural;" "social;" "supernatural;" "no attribution") were assessed.



Ethnic groups did not differ in DUP (p = 0.86). Asian patients were more likely to report supernatural illness attributions in comparison to White (Odds Ratio: 4.02; 95 % Confidence Intervals: 1.52, 10.62) and Black (OR: 3.48; 95 % CI: 1.25, 9.67) patients. In logistic regressions controlling for confounders and illness attributions, Black (OR: 14.00; 95 % CI: 1.30, 151.11) and Asian (OR: 13.29; 95 % CI: 1.26, 140.47) patients were more likely to consult faith-based institutions than White patients. Black patients were more likely to be compulsorily detained than White patients (OR: 4.56; 95 % CI: 1.40, 14.85).



Illness attributions and sociodemographic confounders do not fully explain the ethnic tendency to seek out faith-based institutions. While Asian and Black patients are more likely to seek help from faith-based organisations, this does not appear to lead to a delay in contact with mental health services.
The predictors of foot ulceration in patients with rheumatoid arthritis

This study was conducted to determine the predictors of foot ulceration occurring in patients with rheumatoid arthritis (RA) without diabetes. A multi-centre case control study was undertaken; participants were recruited from eight sites (UK). Cases were adults diagnosed with RA (without diabetes) and the presence of a validated foot ulcer, defined as a full thickness skin defect occurring in isolation on / below the midline of the malleoli and requiring > 14 days to heal. Controls met the same criteria but were ulcer naive. Clinical examination included loss of sensation (10g monofilament); ankle-brachial pressure index (ABPI); forefoot deformity (Platto); plantar pressures (PressureStat); RA disease activity (36 swollen/tender joint counts) and the presence of vasculitis. History taking included past ulceration/foot surgery; current medication and smoking status. Participants completed the Health Assessment Questionnaire (HAQ) and Foot Impact Scale. A total of 83 cases with 112 current ulcers and 190 ulcer naïve controls participated. Cases were significantly older (mean age 71 years; 95 % confidence interval [CI], 69–73 vs. 62 years, 60–64) and had longer RA disease duration (mean 22 years; 19–25 vs. 15, 13–17). Univariate analysis showed that risk of ulceration increases with loss of sensation; abnormality of ABPI and foot deformity. Plantar pressures and joint counts were not significant predictors. HAQ score and history of foot surgery were strongly associated with ulceration (odds ratio [OR] = 1.704, 95 % CI 1.274–2.280 and OR = 2.256, 95 % CI 1.294–3.932). Three cases and two controls presented with suspected cutaneous vasculitis. In logistic regression modelling, ABPI (OR = 0.04; 95 % CI, 0.01–0.28) forefoot deformity (OR = 1.14; 95 % CI, 1.08–1.21) and loss of sensation (OR = 1.22; 95 % CI, 1.10–1.36) predicted risk of ulceration. In patients with RA, ABPI, forefoot deformity and loss of sensation predict risk of ulceration but, in contrast with diabetes, raised plantar pressures do not predict risk.
Neonatal neurobehavioral abnormalities and MRI brain injury in encephalopathic newborns treated with hypothermia.

Neonatal Encephalopathy (NE) is a prominent cause of infant mortality and neurodevelopmental disability. Hypothermia is an effective neuroprotective therapy for newborns with encephalopathy. Post-hypothermia functional-anatomical correlation between neonatal neurobehavioral abnormalities and brain injury findings on MRI in encephalopathic newborns has not been previously described.



To evaluate the relationship between neonatal neurobehavioral abnormalities and brain injury on magnetic resonance imaging (MRI) in encephalopathic newborns treated with therapeutic hypothermia.



Neonates with hypoxic ischemic encephalopathy (HIE) referred for therapeutic hypothermia were prospectively enrolled in this observational study. Neurobehavioral functioning was assessed with the NICU network neurobehavioral scale (NNNS) performed at target age 14 days. Brain injury was assessed by MRI at target age 7-10 days. NNNS scores were compared between infants with and without severe MRI injury.



Sixty-eight term newborns (62% males) with moderate to severe encephalopathy underwent MRI at median 8 days (range 5-16) and NNNS at median 12 days of life (range 5-20). Fifteen (22%) had severe injury on MRI.



Overall Total Motor Abnormality Score and individual summary scores for Non-optimal Reflexes and Asymmetry were higher, while Total NNNS Z-score across cognitive/behavioral domains was lower (reflecting poorer performance) in infants with severe MRI injury compared to those without (p < 0.05).



Neonatal neurobehavioral abnormalities identified by the NNNS are associated with MRI brain injury in encephalopathic newborns post-hypothermia. The NNNS can provide an early functional assessment of structural brain injury in newborns, which may guide rehabilitative therapies in infants after perinatal brain injury.
A controlled study of the antihypertensive effect of carteolol, a newβ-adrenergic receptor blocking drug, in combination with hydrochlorthiazide and amiloride

The antihypertensive effect of carteolol, a new β-blocking agent, added to basal diuretic treatment (hydrochlorthiazide 50 mg and amiloride 5 mg) has been assessed in a controlled trial in 17 patients with mild-to-moderate hypertension. The trial was divided into 4 stages: 1) run-in period with no antihypertensive treatment, 2) diuretic period (the diuretic being continued as basal treatment during the two following periods), 3) carteolol titration period, and 4) double-blind cross-over period comparing carteolol with placebo, which lasted 2 times 4 weeks. Although the diuretic effectively reduced the blood pressure, 17 of the 20 patients originally studied still had an elevated diastolic blood pressure (≧ 95 mmHg) after the diuretic period, thus fulfilling the inclusion criteria for the study. During the titration period carteolol 5 to 20 mg b. i. d. significantly reduced the elevated blood pressure. The blood pressure was reduced to normal in all 17 patients, although in two patients this occurred only during the double-blind period. During the double-blind period, the dose of carteolol was used which had given a satisfactory response during the titration period. The blood pressure in the 14 patients who completed the trial remained low both with carteolol and placebo during the double-blind stage, and was only slightly lower with carteolol than with placebo. This is probably due to a “carry-over” effect. Three patients discontinued the trial due to side effects (1 urticaria, 1 insomnia and 1 nausea) while on carteolol. There was no other difference between carteolol and placebo in the number or severity of side effects.
The effect of a repeat bout of exercise on muscle injury in persons with spinal cord injury

Following an initial bout of damaging exercise, a successive bout of similar exercise typically results in less injury, known as the “protective effect”. Unloading due to spinal cord injury (SCI) increases the susceptibility to contraction-induced muscle injury. We tested the hypothesis that two bouts of isometric actions would evoke the same damage in the quadriceps femoris (QF) of patients with SCI. Six male subjects [32 (5) years old, 182 (9) cm, 81 (21) kg, injury level C6-T7, 6 (2) years post-injury, mean (SD)] were tested at two time points (Time1, Time2), separated by 8 weeks. Magnetic resonance images were taken of the QF prior to, immediately after, and 3 days after electromyostimulation (EMS) that evoked isometric knee extension. EMS (50 Hz) consisted of five sets of ten contractions (2 s on/6 s off, 1 min b/t sets) followed by three sets of ten contractions (1 s on/1 s off, 30 s b/t sets). Relative cross-sectional area of stimulated and injured skeletal muscle was obtained by quantifying pixels with an elevated T2. Relative area of stimulated QF was the same for both time points [92 (6)% and 89 (7)%] as was torque loss (~55%). Three days post-EMS, the relative area of stimulated QF injured was not different between time points [30 (14)% vs 29 (17)%, P>0.05]. These results indicate an absence of a protective effective for repeat exercise bouts separated by 8 weeks in SCI patients using EMS.
Clinical experience of marketed Levetiracetam in an epilepsy clinic—a one year follow up study

Levetiracetam is a new anti-convulsant with impressive pivotal trial credentials. We examined its effectiveness in refractory clinic patients with epilepsy with a year's follow up. Six months after initiation 32% of the patients were seizure free, and 26% at one year. By the end of the 12 months follow up 77% of patients were still taking the drug, having gained benefit from it: 23% had dropped out due to intolerable side effects, seizure increase or lack of efficacy. There is evidence that the drug is broad spectrum and as effective in primary generalised epilepsy as in partial onset epilepsy. Our audit of its use and effectiveness has led us to position it as our first choice add-on drug if the initial monotherapy drug fails.
The relationship between low maternal serum vitamin D levels and glycemic control in gestational diabetes assessed by HbA 1 c levels : an observational cross-sectional study

A great association between vitamin D deficiency and type 2 diabetes mellitus has been suggested in literature. During pregnancy, this deficiency is even more critical. It appears that vitamin D insufficiency during pregnancy may be associated with maternal hazards. The aim of this study was to assess the relation between the levels of 25-hydroxy-cholecalciferol (vitamin D), and the glycemic control in pregnant women.  An observational cross-section study including 160 pregnant women between 20-40 years in age, in their third trimester, divided into two equal groups. First group consisted of 80 women with established diagnosis of gestational diabetes and the second group with proved normal blood glucose levels. We assessed vitamin D in serum, fasting blood glucose, serum insulin and glycosylated hemoglobin (HbA1c) levels and we depicted the insulin sensitivity using the Quantitative insulin sensitivity check index (Quicki). The results were collected and statistically correlated.  The mean vitamin D levels were 46.61 ± 6.087 and 47.25 ± 10.181in controls and women with gestational diabetes mellitus (GDM) respectively. The fasting insulin levels were significantly higher in the group with GDM with a mean of 18.51 ± 6.44 compared to 8.95 ± 2.52 in the control group. The correlation coefficient (r) between HbA1c levels and Vitamin D level was -0.492 with a P value <0.05. Similar associations were also found with the fasting blood sugar levels (r = 0.386) and with Quicki values (r = -0.250). Vitamin D levels correlated significantly with the fasting blood glucose, the fasting serum insulin and the HbA1c levels, the P value in all these correlations were <0.05. The P value with Quicki results was 0.064.  There is a statistically significant negative correlation between the glycemic control and vitamin D levels in serum in the whole study population. The effect of adequate vitamin D replacement on glycemic control was not studied in our work correlation. We suggest larger scale studies addressing this issue.
Small Intestinal Glucose Delivery Affects the Lowering of Blood Glucose by Acute Vildagliptin in Type 2 Diabetes.

The rate of gastric emptying is an important determinant of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) secretion and may influence the magnitude of glucose lowering by dipeptidyl peptidase-4 (DPP-4) inhibitors.



To evaluate the effects of the DPP-4 inhibitor, vildagliptin (VILD), during intraduodenal (ID) glucose infusion at 2 different rates within the physiological range of gastric emptying, in type 2 diabetes.



A total of 16 diet-controlled type 2 diabetic patients were studied on 4 separate days in double-blind, randomized, fashion. On each day, either 5-mg VILD or placebo (PLBO) was given 60 minutes before a 120-minute ID glucose infusion at 2 or 4 kcal/min (ID2 or ID4). Plasma glucose and hormones were measured frequently.



Plasma glucose, insulin, C-peptide, glucagon, total GIP, and total and intact GLP-1 concentrations were higher during ID4 than ID2 (P < .01 for each). Compared with PLBO, VILD was associated with higher intact GLP-1, insulin, and C-peptide and lower glucose and total GIP and GLP-1 (P < .01 for each), without affecting glucagon. There were significant interactions between the rate of ID glucose and VILD treatment on plasma glucose, intact and total GLP-1, and GIP (P < .05 for each) but not insulin, C-peptide, or glucagon. The reduction in glucose and the increment in intact GLP-1 after VILD vs PLBO were 3.3- and 3.8-fold greater, respectively, during ID4 compared with ID2.



These observations warrant further study to clarify whether type 2 diabetic patients with relatively more rapid gastric emptying have greater glucose lowering during treatment with DPP-4 inhibitors.
Associations Between Cognitive Performance and Pain in Chronic Fatigue Syndrome: Comorbidity with Fibromyalgia Does Matter.

In addition to the frequently reported pain complaints, performance-based cognitive capabilities in patients with chronic fatigue syndrome (CFS) with and without comorbid fibromyalgia (FM) are significantly worse than those of healthy controls. In various chronic pain populations, cognitive impairments are known to be related to pain severity. However, to the best of our knowledge, the association between cognitive performance and experimental pain measurements has never been examined in CFS patients.



This study aimed to examine the association between cognitive performance and self-reported as well as experimental pain measurements in CFS patients with and without FM.



Observational study.



The present study took place at the Vrije Universiteit Brussel and the University of Antwerp.



Forty-eight (18 CFS-only and 30 CFS+FM) patients and 30 healthy controls were studied. Participants first completed 3 performance-based cognitive tests designed to assess selective and sustained attention, cognitive inhibition, and working memory capacity. Seven days later, experimental pain measurements (pressure pain thresholds [PPT], temporal summation [TS], and conditioned pain modulation [CPM]) took place and participants were asked to fill out 3 questionnaires to assess self-reported pain, fatigue, and depressive symptoms.



In the CFS+FM group, the capacity of pain inhibition was significantly associated with cognitive inhibition. Self-reported pain was significantly associated with simple reaction time in CFS-only patients. The CFS+FM but not the CFS-only group showed a significantly lower PPT and enhanced TS compared with controls.



The cross-sectional nature of this study does not allow for inferences of causation.



The results underline disease heterogeneity in CFS by indicating that a measure of endogenous pain inhibition might be a significant predictor of cognitive functioning in CFS patients with FM, while self-reported pain appears more appropriate to predict cognitive functioning in CFS patients without FM.
Metabolic and electrophysiological validation of functional MRI.

Although functional MRI is widely used for preoperative planning and intraoperative neuronavigation, its accuracy to depict the site of neuronal activity is not exactly known. Experience with methods that may validate fMRI data and the results obtained when coregistering fMRI with different preoperative and intraoperative mapping modalities including metabolically based (18)F-fluorodeoxyglucose PET, electrophysiologcally based transcranial magnetic stimulation (TMS), and direct electrical cortical stimulation (DECS) are described.



Fifty patients were included. PET was performed in 30, TMS in 10, and DECS in 41 patients. After coregistration using a frameless stereotactic system, results were grouped into overlapping (<1 cm distance), neighbouring (<2 cm), or contradictory (>2 cm).



Comparing fMRI with PET, 18 overlapping, seven neighbouring, and one contradictory result were obtained. In four patients no comparison was possible (because of motion artefacts, low signal to noise ratio, and unusual high tumour metabolism in PET). The comparison of TMS and fMRI showed seven overlapping and three neighbouring results. In three patients no DECS results could be obtained. Of the remaining 38 patients, fMRI hand motor tasks were compared with DECS results of the upper limb muscles in 36 patients, and fMRI foot motor tasks were compared with DECS results of the lower limb on 13 occasions. Of those 49 studies, overlapping results were obtained in 31 patients, and neighbouring in 14. On four occasions fMRI did not show functional information (because of motion artefacts and low signal to noise).



All validation techniques have intrinsic limitations that restrict their spatial resolution. However, of 50 investigated patients, there was only one in whom results contradictory to fMRI were obtained. Although it is not thought that fMRI can replace the intraoperatively updated functional information (DECS), it is concluded that fMRI is an important adjunct in the preoperative assessment of patients with tumours in the vicinity of the central region.
Effects of a FLAP inhibitor, GSK2190915, in asthmatics with high sputum neutrophils.

Patients with refractory asthma frequently have neutrophilic airway inflammation and respond poorly to inhaled corticosteroids. This study evaluated the effects of an oral 5-lipoxygenase-activating protein (FLAP) inhibitor, GSK2190915, in patients with asthma and elevated sputum neutrophils. Patients received 14 (range 13-16) days treatment with GSK2190915 100 mg and placebo with a minimum 14 day washout in a double-blind, cross-over, randomised design (N = 14). Sputum induction was performed twice pre-dose in each treatment period to confirm sputum neutrophilia, and twice at the end of each treatment period. The primary endpoint was the percentage and absolute sputum neutrophil count, averaged for end-of-treatment visits. GSK2190915 did not significantly reduce mean percentage sputum neutrophils (GSK2190915-placebo difference [95% CI]: -0.9 [-12.0, 10.3]), or mean sputum neutrophil counts (GSK2190915/placebo ratio [95% CI]: 1.06 [0.43, 2.61]). GSK2190915 resulted in a marked suppression (>90%) of sputum LTB4 and urine LTE4, but did not alter clinical endpoints. There were no safety issues. Despite suppressing the target mediator LTB4, FLAP inhibitor GSK2190915 had no short-term effect on sputum cell counts or clinical endpoints in patients with asthma and sputum neutrophilia.