nils-herrmann/clean_scirepeval huggingface dataset:
Effect of Buprenorphine Implants on Illicit Opioid Use Among Abstinent Adults With Opioid Dependence Treated With Sublingual Buprenorphine: A Randomized Clinical Trial.

The effectiveness of buprenorphine treatment of opioid dependence is limited by suboptimal medication adherence, abuse, and diversion.



To determine whether 6-month buprenorphine implants are noninferior to daily sublingual buprenorphine as maintenance treatment for opioid-dependent patients with stable abstinence.



Outpatient, randomized, active-controlled, 24-week, double-blind, double-dummy study conducted at 21 US sites from June 26, 2014, through May 18, 2015. Outpatients were prescribed daily sublingual buprenorphine for 6 months or more, were abstinent while taking 8 mg/d or less of sublingual buprenorphine for 90 days or longer, and were determined to be clinically stable by their physician.



Participants were randomized to receive sublingual buprenorphine plus 4 placebo implants or sublingual placebo plus four 80-mg buprenorphine hydrochloride implants (expected efficacy, 24 weeks).



The primary end point was between-group difference in proportion of responders (≥4 of 6 months without opioid-positive urine test result [monthly and 4 times randomly] and self-report). The noninferiority established for the lower bound of the 95% confidence interval was greater than -0.20 (P < .025). Secondary end points included cumulative percentage of negative opioid urine results, abstinence, and time to first illicit opioid use. Safety was assessed by adverse event reporting.



Of 177 participants (mean age, 39 years; 40.9% female), 90 were randomized to sublingual buprenorphine with placebo implants and 87 to buprenorphine implants with sublingual placebo; 165 of 177 (93.2%) completed the trial. Eighty-one of 84 (96.4%) receiving buprenorphine implants and 78 of 89 (87.6%) receiving sublingual buprenorphine were responders, an 8.8% difference (1-sided 97.5% CI, 0.009 to ∞; P < .001 for noninferiority). Over 6 months, 72 of 84 (85.7%) receiving buprenorphine implants and 64 of 89 (71.9%) receiving sublingual buprenorphine maintained opioid abstinence (hazard ratio, 13.8; 95% CI, 0.018-0.258; P = .03). Non-implant-related and implant-related adverse events occurred in 48.3% and 23% of the buprenorphine implant group and in 52.8% and 13.5% of participants in the sublingual buprenorphine group, respectively.



Among adults with opioid dependence maintaining abstinence with a stable dose of sublingual buprenorphine, the use of buprenorphine implants compared with continued sublingual buprenorphine did not result in an inferior likelihood of remaining a responder. However, the study population had an exceptionally high response rate in the control group, and further studies are needed in broader populations to assess the efficacy in other settings.
The Scars of Childhood Adversity: Minor Stress Sensitivity and Depressive Symptoms in Remitted Recurrently Depressed Adult Patients

Childhood adversity may lead to depressive relapse through its long-lasting influence on stress sensitivity. In line with the stress sensitization hypothesis, minor (daily) stress is associated with depressive relapse. Therefore, we examine the impact of childhood adversity on daily stress and its predictive value on prospectively assessed depressive symptoms in recurrently depressed patients.



Daily stress was assessed in recurrently depressed adult patients, enrolled into two randomized trials while remitted. The reported intensity and frequency of dependent and independent daily stress was assessed at baseline. Independent stress is externally generated, for example an accident happening to a friend, while dependent stress is internally generated, for example getting into a fight with a neighbor. Hierarchical regression analyses were performed with childhood adversity, independent and dependent daily stress as predictor variables of prospectively measured depressive symptoms after three months of follow-up (n = 138).



We found that childhood adversity was not significantly associated with a higher frequency and intensity of daily stress. The intensity of both independent and dependent daily stress was predictive of depressive symptom levels at follow-up (unadjusted models respectively: B = 0.47, t = 2.05, p = 0.041, 95% CI = 0.02-0.92; B = 0.29, t = 2.20, p = 0.028, 95% CI = 0.03-0.55). No associations were found between childhood adversity and depressive symptoms at follow-up.



No evidence was found supporting stress sensitization due to the experience of childhood adversity in this recurrently depressed but remitted patient group. Nevertheless, our research indicates that daily stress might be a target for preventive treatment.
Lack of agreement between tonometric and gastric juice partial carbon dioxide tension

Our goal was to compare measurement of tonometered saline and gastric juice partial carbon dioxide tension (PCO2). In this prospective observational study, 112 pairs of measurements were simultaneously obtained under various hemodynamic conditions, in 15 critical care patients. Linear regression analysis showed a significant correlation between the two methods of measuring PCO2 (r(2) = 0.43; P < 0.0001). However, gastric juice PCO2 was systematically higher (mean difference 51 mmHg). The 95% limits of agreement were 315 mmHg and the dispersion increased as the values of PCO2 increased. Tonometric and gastric juice PCO2 cannot be used interchangeably. Gastric juice PCO2 measurement should be interpreted with caution.
Diagnostic validity of line bisection in the acute phase of stroke

The line bisection task is commonly depicted as a valid diagnostic tool to help differentiate between primary visual field defects and spatial neglect. However, recent studies have addressed possible drawbacks in the acute phase after stroke onset. We investigated these critical assumptions in a large and homogeneous sample of 180 acute stroke patients. Line bisection, cancellation performance, copying, and primary visual field defects were assessed in 180 acute right-hemispheric stroke patients. Effects of visual field defects and concurrent spatial neglect on line bisection were analyzed by multiple regression to account for possible additive and interactive effects. The relation between line bisection and other tests applied in spatial neglect was explored by factorial analysis. We found no evidence for the existence of a contralesional 'hemianopic line bisection error' in acute patients with primary visual field defects. Such patients even showed a more pronounced ipsilesional line bisection error. Second, the factorial analysis revealed that the line bisection task on the one hand and cancellation/copying tasks on the other were represented by different factors, indicating that they make different cognitive demands. In the acute phase of stroke, line bisection does not appear to be a valid task to diagnose neither primary visual field defects nor spatial neglect (the latter as defined by its core symptoms (cf., Karnath and Rorden, 2012) which are typically captured with cancellation/copying tasks).
Use of strong opioids in advanced cancer pain: a randomized trial.

The World Health Organization (WHO) guidelines for the treatment of cancer pain recommend nonopioid analgesics as first-line therapy, so-called "weak" analgesics combined with nonopioid analgesics as second-line therapy, and so-called "strong" opioids (with nonopioid analgesics) only as third-line therapy. However, these guidelines can be questioned with regard to the extent of efficacy as well as the rationale for not using strong opioids as first-line treatment, especially in terminal cancer patients. The purpose of this randomized study was to prospectively compare the efficacy and tolerability of strong opioids as first-line agents with the recommendations of the WHO in terminal cancer patients. One hundred patients with mild-moderate pain were randomized to treatment according to WHO guidelines or to treatment with strong opioids. Evaluated outcomes included pain intensity, need for change in therapy, quality of life, Karnofsky Performance Status, general condition of the patient, and adverse events. No between-treatment differences were observed for changes in quality of life or performance status, but patients started on strong opioids had significantly better pain relief than patients treated according to WHO guidelines (P=0.041). Additionally, patients started on strong opioids required significantly fewer changes in therapy, had greater reduction in pain when a change was initiated, and reported greater satisfaction with treatment than the comparator group (P=0.041). Strong opioids were safe and well-tolerated, with no development of tolerance or serious adverse events. These data suggest the utility of strong opioids for first-line treatment of pain in patients with terminal cancer.
Prenatal drug exposure and maternal and infant feeding behaviour.

To evaluate feeding difficulties and maternal behaviour during a feeding session with 1 month old infants prenatally exposed to cocaine and/or opiates.



The study is part of the maternal lifestyle study, which recruited 11 811 subjects at four urban hospitals, then followed 1388 from 1 to 36 months of age. Exposure to cocaine and opiates was determined by maternal interview and meconium assay. At the 1 month clinic visit, biological mothers were videotaped while bottle feeding their infants. This sample included 364 exposed to cocaine, 45 exposed to opiates, 31 exposed to both drugs, and 588 matched comparison infants. Mothers were mostly black, high school educated, and on public assistance. Videotapes were coded without knowledge of exposure status for frequency, duration and quality of infant sucking, arousal, feeding problems, and maternal feeding activity and interaction.



No cocaine effects were found on infant feeding measures, but cocaine-using mothers were less flexible (6.29 v 6.50), less engaged (5.77 v 6.22), and had shorter feeding sessions (638 v 683 seconds). Opiate exposed infants showed prolonged sucking bursts (29 v 20 seconds), fewer pauses (1.6 v 2.2 per minute), more feeding problems (0.55 v 0.38), and increased arousal (2.59 v 2.39). Their mothers showed increased activity (30 v 22), independent of their infants' feeding problems.



Previous concerns about feeding behaviour in cocaine exposed infants may reflect the quality of the feeding interaction rather than infant feeding problems related to prenatal exposure. However, opiate exposed infants and their mothers both contributed to increased arousal and heightened feeding behaviour.
Long-term treatment with antipsychotic drugs in conventional doses prolonged QTc dispersion, but did not increase ventricular tachyarrhythmias in patients with schizophrenia in the absence of cardiac disease

The aim of this study was to examine the hypothesis that long-term treatment with antipsychotic drugs in conventional doses prolongs QTc dispersion and increases ventricular tachyarrhythmias in patients with schizophrenia in the absence of cardiac disease.  We measured QTc and QTc dispersion and ventricular tachyarrhythmias in 64 patients with schizophrenia, including 59 patients who received psychiatric medications, and five patients who did not receive psychiatric medications, and 45 healthy volunteers. None of the subjects had a history of cardiac disease or showed any abnormality in chest radiograph and transthoracic echocardiographic studies. None of the subjects had electrolyte abnormality. None of the subjects were taking drugs known to influence the QT interval, other than psychiatric medications.  QTc and QTc dispersion were significantly (P < 0.017) increased in patients who received psychiatric medications compared with patients who did not receive psychiatric medications, or with healthy volunteers [QTc: 0.442 (0.029), 0.418 (0.029), 0.417 (0.028) s, QTc dispersion: 0.054 (0.013), 0.038 (0.017), 0.038 (0.009) s]. Daily ventricular premature beats were 183 (689), 77 (23), and 86 (149), respectively. No ventricular tachycardia was observed. There were no correlation between QTc and QTc dispersion and ventricular premature beats.  Long-term treatment with antipsychotic drugs in conventional doses prolonged both QTc and QTc dispersion in patients with schizophrenia, but did not increase ventricular tachyarrhythmias in patients with schizophrenia in the absence of cardiac disease. However, despite the negative findings, ventricular tachyarrhythmias may occur as a rare side-effect of antipsychotic drugs, particularly if a patient has additional risk factors.
Serum N-Glycan Profiling Predicts Prognosis in Patients Undergoing Hemodialysis

The aim of this study is to evaluate the usefulness of serum N-glycan profiling for prognosis in hemodialysis patients.



Serum N-glycan analysis was performed in 100 hemodialysis patients in June 2008 using the glycoblotting method, which allows high-throughput, comprehensive, and quantitative N-glycan analysis. All patients were longitudinally followed up for 5 years. To evaluate the independent predictors for prognosis, patients' background, blood biochemistry, and N-glycans intensity were analyzed using Cox regression multivariate analysis. Selected N-glycans and independent factors were evaluated using the log-rank test with the Kaplan-Meier method to identify the predictive indicators for prognosis. Each patient was categorized according to the number of risk factors to evaluate the predictive potential of the risk criteria for prognosis.



In total, 56 N-glycan types were identified in the hemodialysis patients. Cox regression multivariate analysis showed cardiovascular events, body mass index, maximum intima media thickness, and the serum N-glycan intensity of peak number 49 were predictive indicators for overall survival. Risk classification according to the number of independent risk factors revealed significantly poor survival by increasing the number of risk factors.



Serum N-glycan profiling may have a potential to predict prognosis in patients undergoing hemodialysis.
Cost-Benefit Analysis of Prophylactic Granulocyte Colony-Stimulating Factor During CHOP Antineoplastic Therapy for Non-Hodgkin’s Lymphoma

Several randomised comparative trials have shown that granulocyte colony-stimulating factor (G-CSF) reduces the duration of neutropenia, hospitalisation and intravenous antibacterial use in patients with cancer who are receiving high-dosage antineoplastic therapy. However, one area that has received less attention is the role of G-CSF in standard-dosage antineoplastic regimens. One such treatment that is considered to have a low potential for inducing fever and neutropenia is the CHOP regimen (cyclophosphamide, doxorubicin, vincristine and prednisone) for non-Hodgkin’s lymphoma. We conducted a cost-benefit analysis from a societal perspective in order to estimate the net cost or benefit of prophylactic G-CSF in this patient population. This included direct costs for hospitalisation with antibacterial support, as well as indirect societal costs, such as time off work and antineoplastic therapy delays secondary to neutropenia. The findings were then tested by a comprehensive sensitivity analysis. The administration of G-CSF at a dosage of 5 µg/kg/day for 11 doses following CHOP resulted in an overall net cost of $Can1257. In the sensitivity analysis, lowering the G-CSF dosage to 2 µg/kg/day generated a net benefit of $Can6564, indicating a situation that was cost saving to society. The results of the current study suggest that the use of G-CSF in patients receiving CHOP antineoplastic therapy produces a situation that is close to achieving cost neutrality. However, low-dosage (2 µg/kg/day) G-CSF is an economically attractive treatment strategy because it may result in overall savings to society.
Poor agreement between QuantiFERON-TB Gold test and tuberculin skin test results for the diagnosis of latent tuberculosis infection in rheumatoid arthritis patients and healthy controls

We investigated the agreement between the QuantiFERON-TB Gold (QFT-Gold) test and the tuberculin skin test (TST) in the diagnosis of latent tuberculosis infection in patients with rheumatoid arthritis (RA), compared with healthy controls, in Korea.



We recruited 64 patients with RA and 79 healthy controls at two university hospitals in South Korea. The participants underwent both the QFT-Gold test and the TST simultaneously between August 2006 and February 2009. All patients were diagnosed using the classification criteria for RA revised in 1987 by the American College of Rheumatology. Bacillus Calmette-Guérin vaccination status and current medications were evaluated, and disease activities were assessed using the Disease Activity Score in 28 joints. Eleven patients with RA produced indeterminate QFT-Gold test results and were thus excluded from the kappa analysis.



Based on an induration of 10 mm in diameter as the TST cutoff value, the QFT-Gold test and TST demonstrated 75.0% agreement (κ = 0.23) in patients with RA and 75.9% agreement (κ = 0.19) in healthy controls. Among the 56 patients with RA who had negative TST results, 11 patients (17.2%) also yielded indeterminate QFT-Gold results.



Our study showed poor agreement between the results of the QFT-Gold test and the TST in both RA patients and healthy controls. Based on these findings, we emphasize the importance of making clinical decisions in the diagnosis of latent tuberculosis in Koreans with or without RA.
Association of gastric cancer with tyrosine hydroxylase gene polymorphism in a northwestern Chinese population

Gastric cancer (GC) is a common and complex disease caused by multifactors. The aim of our study was to investigate the association of the common polymorphisms detected in insulin-like growth factor (IGF)-II, IGF-1 receptor, insulin-like growth factor binding protein 1 (IGFBP1), insulin (INS) and tyrosine hydroxylase (TH) with susceptibility to GC in a northwestern Chinese population. One hundred and fifty-four GC patients and 166 healthy controls were investigated in our study. The genotypes were determined by polymerase chain reaction-restriction fragment length polymorphism. The frequencies of CC and CT genotypes of TH were significantly higher in GC patients than in controls, as the odds ratios were 3.03 (95%CI 1.438–6.362, P=0.003) and 1.97 (95%CI 1.218–3.167, P=0.005), respectively. No association was found between the polymorphisms of IGF-II ApaI, insulin-like growth factor-1 receptor MnlI, IGFBP1 Bgl II and INS-23HphI and the development of GC. The presence of CC and CT genotypes of TH was associated with a significantly increased risk of GC. But the polymorphisms of other genes detected did not indicate an increased risk of GC in the investigated population.
Impact of a bilingual education intervention on the quality of life of Latina breast cancer survivors.

To test the effectiveness of a bilingual education intervention to improve the quality of life (QOL) of Latina breast cancer survivors (BCSs) after completing primary treatment for breast cancer.



A two-group prospective, longitudinal, randomized, controlled trial.



An ambulatory-care setting of a designated comprehensive cancer center in southern California.


SAMPLE
52 English- and Spanish-speaking Latina BCSs.



Women were randomly assigned to the experimental or attention control group and completed measures of QOL, uncertainty, distress, and acculturation at baseline, and at three and six months postintervention.



QOL, uncertainty, and distress.



After controlling for acculturation, the four dimensions of QOL increased slightly in the groups or remained unchanged without significant group-by-time interaction. The social and psychological well-being subscales had the lowest scores, followed by physical and spiritual well-being. Although the group-by-time interaction was not statistically significant, the post-hoc difference for total QOL between time 2 and time 3 in the experimental group approached significance, with a slight increase in total QOL.



Latina BCSs have multiple survivorship and QOL concerns that might put them at risk for poor QOL.



More culturally congruent intervention studies are needed to address the paucity of intervention research with Latina BCS.



Core values must be incorporated in the development of health education programs. Those programs also should be linguistically appropriate and available to non-English-speaking Latinas. In this way, the informational and supportive needs of all BCSs can be met.
Disease activity score-driven therapy versus routine care in patients with recent-onset active rheumatoid arthritis: data from the GUEPARD trial and ESPOIR cohort

To compare the efficacy of disease activity score in 28 joints (DAS28ESR)-driven therapy with anti-tumour necrosis factor (patients from the GUEPARD trial) and routine care in patients with recent-onset rheumatoid arthritis (patients of the ESPOIR cohort).



After matching GUEPARD and ESPOIR patients on the basis of a propensity score and a 1:2 ratio, at baseline all patients had comparable demographic characteristics, rheumatoid factor, anticyclic citrullinated peptide antibody positivity and clinical disease activity parameters: erythrocyte sedimentation rate, C-reactive protein, mean DAS (6.26±0.87), Sharp/van der Heijde radiographic score (SHS), health assessment questionnaire (HAQ). Disease duration was longer in GUEPARD patients (5.6±4.6 vs 3.5±2.0 months, p<0.001). After 1 year, the percentage of patients in remission with an HAQ (<0.5) and an absence of radiological progression was higher in the tight control group (32.3% vs 10.2%, p=0.011) as well as the percentage of patients in low DAS with an HAQ (<0.5) and an absence of radiological progression (36.1% vs 18.9%, p=0.045). However, there was no difference in the decrease in DAS, nor in the percentage of EULAR (good and moderate), ACR20, ACR50 and ACR70 responses. More patients in the tight control group had an HAQ below 0.5 (70.2% vs 45.2%, p=0.005). Overall, pain, patient and physician assessment and fatigue decreased more in the tight control group. The mean SHS progression was similar in the two groups as was the percentage of patients without progression.



In patients with recent onset active rheumatoid arthritis, a tight control of disease activity allows more patients to achieve remission without disability and radiographic progression.
[Comparison between aquatic-biodanza and stretching for improving quality of life and pain in patients with fibromyalgia].

To determine the level of improvement, as regards pain, impact on fibromyalgia and depression, achieved by patients with fibromyalgia by comparing aquatic biodanza and stretching exercises.



Randomised controlled trial with two intervention groups.


LOCATION
Five health centres (Almeria).



A total of 82 fibromyalgia patients between 18 and 65 years old, diagnosed by American College of Rheumatology criteria, were included, with 12 patients declining to take part in the study. The 70 remaining patients were randomly assigned to two groups of 35 patients each: aquatic biodanza and stretching exercises. Those who did not attend in at least 14 sessions or changed their treatment during the studio were excluded. The final sample consisted of 19 patients in aquatic biodanza group and 20 in stretching group. The limitations of the study included, the open evaluation design and a sample size reduced by defaults.



The outcome measures were sociodemographic data, quality of life (Fibromyalgia Impact Questionnaire), pain (McGill-Melzack questionnaire; and Visual Analogue Scale), pressure algometry (Wagner FPI10 algometer) and depression (Beck Inventory). These were carried out before and after a 12-week therapy.



The mean age of the sample was 55.41 years. The mean period from diagnosis was 13.44 years. The sample consisted mainly of housewives. There were significant differences (P<.05) between groups, in pain (P<.01), fibromyalgia impact (P<.01), and depression (P<.04) after the treatment.



The biodanza aquatic exercises improve pain and quality of life in fibromyalgia patients.