nils-herrmann/clean_scirepeval huggingface dataset:
HARMONY 4: randomised clinical trial comparing once-weekly albiglutide and insulin glargine in patients with type 2 diabetes inadequately controlled with metformin with or without sulfonylurea

The aim of this study was to compare the efficacy and safety of once-weekly albiglutide with once-daily insulin glargine (A21Gly,B31Arg,B32Arg human insulin) in patients with type 2 diabetes inadequately controlled on metformin with or without sulfonylurea. This was a randomised, open-label, multicentre (n = 222), parallel-group, non-inferiority out-patient clinical trial, with 779 patients enrolled in the study. The study was conducted in 222 centres located in four countries. Patients aged ≥18 years with type 2 diabetes treated with metformin (±sulfonylurea) for at least 3 months with a baseline HbA1c 7.0–10.0% (53.0–85.8 mmol/mol) were randomly assigned (2:1) via a computer-generated randomisation sequence with a voice response system to receive albiglutide (30 mg once a week, n = 504) or insulin glargine (10 U once a day, n = 241) added to current therapy. Participants and investigators were not masked to treatment assignment. Doses of each medication were adjusted on the basis of the glycaemic response. The primary endpoint was change from baseline in HbA1c at week 52. In the albiglutide group, HbA1c declined from 8.28 ± 0.90% (67.0 ± 9.8 mmol/mol) (mean ± SD) at baseline to 7.62 ± 1.12% (59.8 ± 12.2 mmol/mol) at week 52. A similar reduction occurred in the insulin glargine group (8.36 ± 0.95% to 7.55 ± 1.04% [67.9 ± 10.4 to 59.0 ± 11.4 mmol/mol]). The model-adjusted treatment difference of 0.11% (95% CI −0.04%, 0.27%) (1.2 mmol/mol [95% CI −0.4, 3.0 mmol/mol]) indicated non-inferiority of albiglutide to insulin glargine based on the pre-specified non-inferiority margin of 0.3% (3.3 mmol/mol, p = 0.0086). Body weight increased in the insulin glargine group and decreased in the albiglutide group, with a mean treatment difference of −2.61 kg (95% CI −3.20, −2.02; p < 0.0001). Documented symptomatic hypoglycaemia occurred in a higher proportion of patients in the insulin glargine group than in the albiglutide group (27.4% vs 17.5%, p = 0.0377). Albiglutide was non-inferior to insulin glargine at reducing HbA1c at week 52, with modest weight loss and less hypoglycaemia. Both drugs were well tolerated. Albiglutide may be considered an alternative to insulin glargine in this patient population.
[Variability in renal dysfunction defining criteria and detection methods in intensive care units: are the international consensus criteria used for diagnosing renal dysfunction?].

To evaluate variability in the detection and prevention of acute kidney injury (AKI) in the intensive care unit (ICU), and application of the international recommendations in this field (Acute Dialysis Quality Initiative [ADQI] and Acute Kidney Injury Network [AKIN]).



A prospective, observational, multicenter study.



A total of 42 ICUs in 32 hospitals (78% in third level hospitals and 70.7% general units) recruited for a study on the prevalence of AKI (COFRADE).



Survey.



Aspects related to AKI detection and prevention and renal replacement therapy protocols.



The method used for estimating glomerular filtration rate was serum creatinine in 36.6%, creatinine clearance in 41.5% and equations in 22%; none reported using cystatin-C. Only 39.1% ICUs acknowledged the use of stratification systems (13 RIFLE and 3 AKIN). A total of 48.8% ICUs had no written protocols for AKI prevention, 31.7% reported using them only for contrast nephropathy, 7.3% for nephrotoxic drugs and 12.2% for both. In contrast, 63.4% participants had written protocols for renal replacement therapy, 70.7% had implemented a training program, and 53.7% had some method for adjusting doses of drugs when on renal replacement therapy.



We observed important variability regarding diagnostic criteria and prevention of AKI in Spanish ICUs, the application of ADQI or AKIN recommendations still being low in our units. Renal replacement therapy seems to generate more concern among our intensivists than AKI management.
Evaluation of the medical care of patients with hypertension in an emergency department and in ambulatory hypertension unit.

To evaluate the characteristics of the patients receiving medical care in the Ambulatory of Hypertension of the Emergency Department, Division of Cardiology, and in the Emergency Unit of the Clinical Hospital of the Ribeirão Preto Medical School.



Using a protocol, we compared the care of the same hypertensive patients in on different occasions in the 2 different places. The characteristics of 62 patients, 29 men with a mean age of 57 years, were analyzed between January 1996 and December 1997.



The care of these patients resulted in different medical treatment regardless of their clinical features and blood pressure levels. Thus, in the Emergency Unit, 97% presented with symptoms, and 64.5% received medication to rapidly reduce blood pressure. In 50% of the cases, nifedipine SL was the elected medication. Patients who applied to the Ambulatory of Hypertension presenting with similar features, or, in some cases, presenting with similar clinically higher levels of blood pressure, were not prescribed medication for a rapid reduction of blood pressure at any of the appointments.



The therapeutic approach to patients with high blood pressure levels, symptomatic or asymptomatic, was dependent on the place of treatment. In the Emergency Unit, the conduct was, in the majority of cases, to decrease blood pressure immediately, whereas in the Ambulatory of Hypertension, the same levels of blood pressure, in the same individuals, resulted in therapeutic adjustment with nonpharmacological management. These results show the need to reconsider the concept of hypertensive crises and their therapeutical implications.
Stent-assisted coiling in ruptured cerebral aneurysms: multi-center experience in acute phase

The purpose of this study is to report on a multi-center experience of ruptured intracranial aneurysms treated in acute phase with stent-assisted coil embolization, including primary success rates and midterm follow-up results. Retrospective analysis was performed on a sample of 40 patients (14 men, 26 women, mean age 59.7 years) affected by ruptured saccular aneurysms and treated by stent-assisted coiling in acute phase; double antiplatelet therapy with clopidogrel bisulphate and acetylsalicylic acid was started after the procedure. Angiographic follow-up at 1 year was recorded. 20 % of the aneurysms were located in the posterior circulation, and 85 % presented a wide neck. Mean size of the sac was 7 mm (range 3–22 mm). Complete sac exclusion was obtained in 92.5 % and neck remnant in 7.5 %. The overall complications rate was 15 %. In 7.5 %, stent occlusion occurred intra-procedurally. In 12.5 %, re-bleeding was detected within 3 weeks after the procedure. Ischemic area related to the procedure was observed at follow-up in 7.5 %. Hydrocephalus developed in 15 %. 7.5 % presented with sac re-bleeding between 1 and 5 months after the procedure. In 15 %, the 3–6 months of follow-up revealed aneurysm refilling. 25 % of the patients presented vessel stenosis at the 1-year DSA of control. 33 % of the patients reported sensory–motor deficits. 82.5 % had a favorable outcome (GOS: IV–V), while 17.5 % presented a poor score (GOS: I–III). Stent-assisted coil embolization is a feasible endovascular treatment option for ruptured intracranial aneurysms, which is difficult to approach with simple coiling; however, neurointerventionalists need to consider a mild increase of post-procedural complications rate.
Walking index for spinal cord injury (WISCI): an international multicenter validity and reliability study

Construction of an international walking scale by a modified Delphi technique.  The purpose of the study was to develop a more precise walking scale for use in clinical trials of subjects with spinal cord injury (SCI) and to determine its validity and reliability.  Eight SCI centers in Australia, Brazil, Canada (2), Korea, Italy, the UK and the US.  Original items were constructed by experts at two SCI centers (Italy and the US) and blindly ranked in an hierarchical order (pilot data). These items were compared to the Functional Independence Measure (FIM) for concurrent validity. Subsequent independent blind rank ordering of items was completed at all eight centers (24 individuals and eight teams). Final consensus on rank ordering was reached during an international meeting (face validation). A videotape comprised of 40 clips of patients walking was forwarded to all eight centers and inter-rater reliability data collected.  Kendall coefficient of concordance for the pilot data was significant (W=0.843, P<0.001) indicating agreement among the experts in rank ordering of original items. FIM comparison (Spearman's rank correlation coefficient=0.765, P<0.001) showed a theoretical relationship, however a practical difference in what is measured by each scale. Kendall coefficient of concordance for the international blind hierarchical ranking showed significance (W=0.860, P<0.001) indicating agreement in rank ordering across all eight centers. Group consensus meeting resulted in a 19 item hierarchical rank ordered `Walking Index for Spinal Cord Injury (WISCI)'. Inter-rater reliability scoring of the 40 video clips showed 100% agreement.  This is the first time a walking scale for SCI of this complexity has been developed and judged by an international group of experts. The WISCI showed good validity and reliability, but needs to be assessed in clinical settings for responsiveness.Spinal Cord (2000) 38, 234–243.
Embolization of the Gastroduodenal Artery Before Selective Internal Radiotherapy: A Prospectively Randomized Trial Comparing Standard Pushable Coils with Fibered Interlock Detachable Coils

The purpose of this study was compare embolization of the gastroduodenal artery (GDA) using standard pushable coils with the Interlock detachable coil (IDC), a novel fibered mechanically detachable long microcoil, in patients scheduled for selective internal radiotherapy (SIRT). Fifty patients (31 male and 19 female; median age 66.6 ± 8.1 years) were prospectively randomized for embolization using either standard coils or IDCs. Procedure time, radiation dose, number of embolization devices, complications, and durability of vessel occlusion at follow-up angiography were recorded. The procedures differed significantly in time (14:32 ± 5:56 min for standard coils vs. 2:13 ± 1:04 min for IDCs; p < 0.001); radiation dose for coil deployment (2479 ± 1237 cGycm² for standard coils vs. 275 ± 268 cGycm² for IDCs; p < 0.001); and vessel occlusion (17:18 ± 6:39 min for standard coils vs. 11:19 ± 7:54 min for IDCs; p = 0.002). A mean of 6.2 ± 1.8 coils (n = 27) were used in the standard coil group, and 1.3 ± 0.9 coils (p < 0.0001) were used in the IDC group (n = 23) because additional pushable coils were required to achieve GDA occlusion in 4 patients. In 2 patients, the IDC could not be deployed through a Soft-VU catheter. One standard coil dislodged in the hepatic artery and was retrieved. Vessel reperfusion was noted in only 1 patient in the standard coil group. Controlled embolization of the GDA with fibered IDCs was achieved more rapidly than with pushable coils. However, vessel occlusion may not be obtained using a single device only, and the use of sharply angled guiding catheters hampered coil pushability.
Cumulative pharmacokinetic study of oxaliplatin, administered every three weeks, combined with 5-fluorouracil in colorectal cancer patients.

The cumulative pharmacokinetic pattern of oxaliplatin, a new diamminecyclohexane platinum derivative, was studied in patients with metastatic colorectal cancer. Oxaliplatin was administered by i. v. infusion (130 mg/m2) over 2 h every 3 weeks, and 5-fluorouracil and leucovorin were administered weekly. A very sensitive method, inductively coupled plasma-mass spectrometry, allowed for the determination of total plasma and ultracentrifugable (UC) and RBC platinum levels on day 1, at 0, 2, and 5 h, and on days 8, 15, and 22. Sixteen patients underwent three or more courses, and six of them underwent six or more courses. The platinum concentration curves were quite similar from one course to another, with a high peak value 2 h after administration (day 1, Cmax = 3201 +/- 609 microgram/liter) and a rapid decrease (day 8, 443 +/- 99 microgram/liter). Cmax of both total and UC platinum levels in plasma remained unchanged throughout the treatment. The mean total platinum half-life in plasma was 9 days. We found residual levels of total platinum on day 22 (161 +/- 45 microgram/liter), but we observed no significant accumulation for the four first cycles (P = 0.57). In contrast, platinum accumulated significantly in RBCs after three courses (+91% at day 22 of the third cycle versus day 22 of the first cycle, P = 0.000018), and its half-life there was equivalent to that of RBCs. The patterns of UC and total platinum concentration curves were very similar and correlated significantly (P < 10(-6)) at all sampling times. The mean UC:total platinum ratio was 15% at day 1 and 5% at days 8, 15, and 22 in the 3-week treatment course. Unlike cisplatin, which rapidly accumulates in plasma as both free and bound platinum, oxaliplatin does not accumulate in plasma, but it does accumulate in RBCs, after repeated cycles at the currently recommended dose (130 mg/m2) and schedule of administration (every 3 weeks).
Posttraumatic stress disorder symptoms in treatment-seeking pathological gamblers.

Little is known about posttraumatic stress disorder (PTSD) among pathological gamblers (PGs), even though the two disorders share several clinical characteristics. We examined the relationship between pathological gambling and PTSD on measures of gambling disorder severity, experience of specific traumas, psychiatric symptoms, impulsivity, and dissociation. A total of 149 treatment-seeking PGs were surveyed. Participants were divided into two groups on the basis of their score on the PTSD Checklist (Weathers, Litz, Herman, Huska, & Keane, 1993). Thirty-four percent (n = 51) reported a high frequency of PTSD symptoms. Participants who had high scores reported greater lifetime gambling severity, psychiatric symptom severity, impulsivity, and dissociation than participants who had low PTSD symptom scores. These findings point to a need for more assessment and research about PTSD in PGs.
Efficacy and safety of chitosan HEP-40 in the management of hypercholesterolemia: a randomized, multicenter, placebo-controlled trial.

Hypercholesterolemia is an important risk factor for cardiovascular disease (CVD).



To compare the efficacy of a 12-week treatment regimen with HEP-40 low-molecular weight chitosan given at daily doses of 1,200 mg, 1,600 mg, and 2,400 mg in reducing serum low-density lipoprotein cholesterol (LDL-C) in patients with low-to-moderate hypercholesterolemia.



The study was a 16-week, multicenter, placebo-controlled, randomized study. Eligible patients were treatment-naive for lipid-lowering medications. Patients were randomly assigned to HEP-40 at the following doses: 400 mg three times daily, 800 mg twice daily, 800 mg three times daily, 2,400 mg once daily, or placebo for 12 weeks. The main outcome measure was the percent change in LDL-C after four weeks of treatment.



Out of 283 patients screened, 105 (37.1%) fulfilled the inclusion criteria and 95 (90.4%) completed the study. The mean (SD) age was 53 (11) years and 62.3 percent were male. The majority of patients (82.9%) were at low 10-year risk for CVD. The results showed an overall treatment effect (p=0.040) with the highest difference from the placebo group observed for the HEP-40 2,400-mg once daily group (-16.9%, p=0.002), followed by 400 mg three times daily (-11.1%, p=0.054), 800 mg three times daily (-9.7%, p=0.065), and 800 mg twice daily (-8.7%, p=0.101). There were 29 predominantly mild adverse events reported by 24 (23%) patients related to the study treatment, most frequently constipation (3.0%) and diarrhea (3.0%).



HEP-40 low-molecular weight chitosan, although not as effective as statins, is efficacious and safe in lowering LDL-C concentrations in treatment-naive patients with low-to-moderate hypercholesterolemia.
Development of a reliable self-report outcome measure for pragmatic trials of communication therapy following stroke: the Communication Outcome after Stroke (COAST) scale.

To develop and validate a clinically feasible measure of communication effectiveness for people with any type of communication problem following stroke.



Cross-sectional, interview-based, psychometric study, building on the development phase for construction of the Communication Outcome after Stroke (COAST) scale.



A community sample from the northwest of England, UK.



One hundred and two people with communication problems (aphasia and/or dysarthria) following a stroke, within the previous 4-12 months.



Administration of the COAST scale, on two occasions, within a two-week period, and collection of demographic and other data relating to disability, degree of aphasia (where appropriate) and hospital diagnosis of aphasia/dysarthria.



Acceptability (missing values), reliability (internal consistency and test-retest reliability) and item analysis (item redundancy).



Ninety-seven (visit 1) and 98 (visit 2) respondents provided usable data for the psychometric analysis. The 29-item COAST scale showed good acceptability (few missing values, sample spread 28-100%), internal consistency and test-retest reliability for the scale (alpha = 0.95; ICC = 0.90) and its subscales (alpha = 0.65-0.93; ICC = 0.72-0.88), but possible item redundancy. A revised scale of 20 items was produced, demonstrating good internal consistency and test-retest reliability (alpha = 0.83-92; ICC = 0.72-0.88).



The COAST is a patient-centred, practical and reliable measure that can be used to assess self-perceived communication effectiveness for people with aphasia and/or dysarthria. Further testing on construct validity and responsiveness to change is needed before the measure can be firmly recommended for use within clinical practice and research.
Effect of analgesics and sedatives on the occurrence of spreading depolarizations accompanying acute brain injury.

Spreading depolarizations are waves of mass neuronal and glial depolarization that propagate across the injured human cortex. They can occur with depression of neuronal activity as spreading depressions or isoelectric spreading depolarizations on a background of absent or minimal electroencephalogram activity. Spreading depolarizations are characterized by the loss of neuronal ion homeostasis and are believed to damage functional neurons, leading to neuronal necrosis or neurological degeneration and poor outcome. Analgesics and sedatives influence activity-dependent neuronal ion homeostasis and therefore represent potential modulators of spreading depolarizations. In this exploratory retrospective international multicentre analysis, we investigated the influence of midazolam, propofol, fentanyl, sufentanil, ketamine and morphine on the occurrence of spreading depolarizations in 115 brain-injured patients. A surface electrode strip was placed on the cortex, and continuous electrocorticographical recordings were obtained. We used multivariable binary logistic regression to quantify associations between the investigated drugs and the hours of electrocorticographical recordings with and without spreading depolarizations or clusters of spreading depolarizations. We found that administration of ketamine was associated with a reduction of spreading depolarizations and spreading depolarization clusters (P < 0.05). Midazolam anaesthesia, in contrast, was associated with an increased number of spreading depolarization clusters (P < 0.05). By using a univariate odds ratio analysis, we also found a significant association between ketamine administration and reduced occurrence of isoelectric spreading depolarizations in patients suffering from traumatic brain injury, subarachnoid haemorrhage and malignant hemispheric stroke (P < 0.05). Our findings suggest that ketamine-or another N-methyl-d-aspartate receptor antagonist-may represent a viable treatment for patients at risk for spreading depolarizations. This hypothesis will be tested in a prospective study.
Heated intra-operative intraperitoneal oxaliplatin plus irinotecan after complete resection of peritoneal carcinomatosis: pharmacokinetics, tissue distribution and tolerance.

The purpose of this study was to report the pharmacokinetics (PK) and tolerance profile of intraoperative intraperitoneal chemo-hyperthermia (IPCH) with oxaliplatin and irinotecan.



Thirty-nine patients with peritoneal carcinomatosis (PC) of either gastrointestinal or peritoneal origin underwent complete cytoreductive surgery followed by IPCH with a stable dose of oxaliplatin (460 mg/m(2)), plus one among seven escalating doses of irinotecan (from 300 to 700 mg/m(2)). IPCH was carried out with the abdomen open, for 30 min at 43 degrees C, with 2 l/m(2) of a 5% dextrose instillation in a closed continuous circuit. Patients received intravenous leucovorin (20 mg/m(2)) and 5-fluorouracil (400 mg/m(2)) just before IPCH to maximize the effect of oxaliplatin and irinotecan.



Irinotecan concentration in tumoral tissue increased until 400 mg/m(2) and then remained stable despite dose escalations. It was 16-23 times higher than in non-bathed tissues. Increasing doses of intraperitoneal irinotecan did not modify the PK of intraperitoneal oxaliplatin, and the drug concentration ratio was 17.8 higher in tumoral tissue (bathed) than in non-bathed tissues. The hospital mortality rate was 2.5% and the non-hematological complication rate was 25%. However, grade 3-4 hematological toxicity rate was 58%.



Intraperitoneal heated oxaliplatin (460 mg/m(2)) plus irinotecan (400 mg/m(2)) presented an advantageous PK profile and was tolerated by patients, despite a high hematological toxicity rate.
Measuring quality of life in stroke subjects receiving an implanted neural prosthesis for drop foot.

The aim was to determine if the treatment of a drop foot by means of an implantable two-channel peroneal nerve stimulator improves health-related quality of life (HRQoL). All subjects were measured at baseline and after a follow-up period of 12 and 26 weeks. Twenty-nine stroke survivors with chronic hemiplegia with drop foot who fulfilled the predefined inclusion and exclusion criteria were included in the present randomized controlled trial. The intervention group received an implantable two-channel peroneal nerve stimulator for correction of their drop foot. The control group continued using their conventional walking device, consisting of an ankle-foot orthosis, orthopedic shoes, or no device. HRQoL was assessed in two different ways: (i) by taking descriptive measures, that is, the Short Form-36 (SF-36; generic measure) and the Disability Impact Profile (DIP; specific measure); and (ii) by obtaining preference-based utilities both measured with the time trade-off (direct way) and by calculating them from the EuroQol (EQ-5D) and SF-36. A significant positive effect of the implantable device was found on the physical functioning domain, the general health domain, and the physical component summary score of the SF-36. For the DIP, a significant improvement was found on the domains mobility, self-care, and psychological status in the intervention group. Regarding the preference-based utility measures, a significant effect was found for the utility index calculated from the EQ-5D. The implantable two-channel peroneal nerve stimulator seems to be efficient to improve HRQoL, mainly the domains related to physical functioning. A relation was present between the utility indexes calculated from the EQ-5D and SF-36.