nils-herrmann/clean_scirepeval huggingface dataset:
The role of macular hydration in the evaluation of the effect of intravitreal triamcinolone on visual acuity in eyes with diabetic macular edema

To evaluate the efficacy of intravitreal triamcinolone (IVTA) in eyes with clinically definite diabetic macular edema (DME) by using the parameters visual acuity (VA), central macular thickness (CMT) and macular hydration (MH). Medical records of patients who received IVTA (4 mg/0.1 mL) for DME were reviewed. Optically non-reflective areas which appear dark spaces within the 1000 μm from the center of the macula on OCT scan defined as MH. Best corrected logarithm of minimum angle of resolution (logMAR) visual acuity, CMT as determined by optical coherence tomography (OCT) and MH quantified from the OCT scans by using metamorph analysis were evaluated before the injection and at 1, 3 and 6 months in all, and up to 12 months in some eyes, after the IVTA injection. The correlations between these variables were also studied. 28 eyes of 27 patients were included in the study. Eyes with DME treated by a single IVTA injection responded with a trend towards significant improvement in logMAR VA at 1 (p < 0.0001) and 3 months (p < 0.0001), but no significant improvement in relation to baseline at 6 months was observed (p = 0.07). CMT was significantly reduced at 1 month (p < 0.0001), 3 months (p < 0.0001) and 6 months (p = 0.01) compared to baseline. Like the trend observed in VA improvement, MH also significantly reduced at 1 month (p < 0.0001) and 3 months (p < 0.0001), but not at 6 months (p = 0.14) compared to baseline. There was no correlation between the VA ratio and the CMT ratio (r = 0.18, p = 0.36), but there was a significant correlation between the VA ratio and the MH ratio (r = 0.85, p < 0.0001). There was also an inverse relationship between MH ratio and the age of the patients (r = −0.7089, p = 0.0001). Macular hydration seems to be a better parameter than macular thickness for determining the effectiveness of IVTA treatment in a subset of eyes with DME. Although the treatment effect is temporary, younger patients with DME were more prone to respond with a greater reduction in MH after IVTA injection.
Steady state pharmacokinetic profile of indomethacin in elderly patients and young volunteers

The steady-state pharmacokinetic profile of indomethacin was examined in twelve healthy volunteers (4 m, 8 f; 20–34 y) and in 12 elderly subjects (7 m, 5 f; 70–88 y). Two formulations of indomethacin were examined, providing duplicate data for each subject group. The subjects received each formulation of indomethacin (25 mg tid) for 6 days in a single blind crossover fashion. On day 7, after an overnight fast, a final 25 mg dose of indomethacin was given and plasma concentrations measured over the following 12 h. Kinetic parameters Cpmin, tmx and AUC (0–12 h) were determined. There were no differences in the pharmacokinetic parameters between young and elderly subjects or between data for the two formulations of indomethacin. AUC values (μg · ml−1 · h), for example, for the two formulations in the young subjects were 5.85 and 6.85 while the values for the elderly subjects were 6.55 and 6.50 respectively. When each treatment period was considered independently there was a significant difference between young and elderly subjects with regard to compliance. The rates of non compliance (over and under compliance) using a capsule count technique were, however, low with a mean maximum value of 5.8% being recorded for the elderly subjects.
Short-Term Oral Magnesium Supplementation Suppresses Bone Turnover in Postmenopausal Osteoporotic Women

Magnesium has been shown to increase bone mineral density when used in the treatment of osteoporosis, yet its mechanism of action is obscure. In this study, the effects of daily oral magnesium supplementation on biochemical markers of bone turnover were investigated. Twenty postmenopausal women have been divided into two groups. Ten patients were given magnesium citrate (1,830 mg/day) orally for 30 days. Ten postmenopausal women of matching age, menopause duration, and BMI were recruited as the control group and followed without any medication. Fasting blood and first-void urine samples were collected on days 0, 1, 5, 10, 20, and 30, respectively. Total magnesium, calcium, phosphorus, iPTH and osteocalcin were determined in blood samples. Deoxypyridinoline levels adjusted for creatinine were measured in urine samples. Thirty consecutive days of oral magnesium supplementation caused significantly decrease in serum iPTH levels in the Mg-supplemented group (p < 0.05). Serum osteocalcin levels were significantly increased (p < 0.001) and urinary deoxypyridinoline levels were decreased (p < 0.001) in the Mg-supplemented group. This study has demonstrated that oral magnesium supplementation in postmenopausal osteoporotic women suppresses bone turnover.
[Morphine as first medication for treatment of cancer pain].

The medications used according to the recommendation of the World Health Organization do not promote pain relief in a number of patients with cancer pain. The aim of this study was to evaluate the use of morphine as first medication for the treatment of moderate cancer pain in patients with advanced and/or metastatic disease, as an option to the recommendations of the World Health Organization analgesic ladder.



Sixty patients without opioid therapy, with ≥18 years of age, were randomized into two groups. G1 patients received medication according to the analgesic ladder and started treatment with non-opioids in the first, weak opioids in the second, and strong opioids in the third step; G2 patients received morphine as first analgesic medication. The efficacy and tolerability of initial use of morphine were evaluated every two weeks for three months.



The groups were similar with respect to demographic data. There was no significant difference between the groups regarding pain intensity, quality of life, physical capacity, satisfaction with treatment, need for complementation and dose of morphine. In G1 there was a higher incidence of nausea (p=0.0088), drowsiness (p=0.0005), constipation (p=0.0071) and dizziness (p=0.0376) in the second visit and drowsiness (p=0.05) in the third.



The use of morphine as first medication for pain treatment did not promote better analgesic effect than the ladder recommended by World Health Organization, with higher incidence of adverse effects.
Measurement of clinical change caused by knee replacement

Clinical change may be measured with specific indexes of change or with the difference between single-state examinations. Change scores and transition indexes are the special indexes of change analysed in this study. At the 10-year follow-up of compartmental replacements, the conformity between subsequent Hospital for Special Surgery overall scores and the patient’s opinion of change from before knee replacement was 0.54. This was judged to be unacceptable. It is recommended that a transitional index be included in the clinical evaluation systems used for knee replacement.
Hypofractionation with simultaneous integrated boost for early breast cancer

To evaluate the feasibility of hypofractionation with SIB in all settings in Germany to prepare a multicenter treatment comparison. Eligible patients had histopathologically confirmed breast cancer operated by BCS. Patients received WBI 40.0 Gy in 16 fractions of 2.5 Gy. A SIB with 0.5 Gy per fraction was administered to the tumor bed, thereby giving 48.0 Gy in 16 fractions to the boost-PTV sparing heart, LAD, lung, contralateral breast. The primary study objective was feasibility, administration of specified dose in 16 fractions within 22–29 days with adherence to certain dose constraints (heart; LAD; contralateral breast); secondary endpoints were toxicity, QoL. 151 patients were recruited from 7 institutions between 07/11-10/12. 10 patients met exclusion criteria prior to irradiation. All but two patients (99 %) received the prescribed dose in the PTVs. Adherence to dose constraints and time limits was achieved in 89 % (95 % CI 82 % to 93 %). 11 AE were reported in 10 patients; five related to concurrent endocrine therapy. Two of the AEs were related to radiotherapy: grade 3 hot flushes in two cases. QoL remained unchanged. Hypofractionation with a SIB is feasible and was well tolerated in this study. Die ARO-2010-01-Studie prüfte die Durchführbarkeit einer hypofraktionierten Bestrahlung mit simultan-integriertem Boost (SIB) in unterschiedlichen Versorgungseinrichtungen zur Vorbereitung einer multizentrischen Vergleichsstudie. In die Studie rekrutiert wurden Patientinnen mit histopathologisch gesichertem Mammakarzinom nach brusterhaltender Operation. Bestrahlt wurde die Brust mit 40,0 Gy in 16 Fraktionen à 2,5 Gy Einzeldosis; zusätzlich wurde bei jeder Fraktion ein simultan- integrierter Boost mit 0,5 Gy appliziert, so dass im Boost-PTV (Planungszielvolumen) eine Dosis von 48 Gy in 16 Fraktionen erreicht wurde. Das primäre Zielkriterium war die Durchführbarkeit, definiert als Verabreichung von 48 Gy GD in 16 Fraktionen in mindestens 22 d bis maximal 29 d Therapiezeit unter Einhaltung von Grenzdosen (Lunge, Herz, LAD, kontralaterale Brust); sekundäre Endpunkte waren Toxizität und Lebensqualität. Zwischen 07/2011 und 10/2012 wurden 151 Patientinnen in 7 Prüfzentren rekrutiert.  Patientinnen wurden vor der Strahlentherapie Ausschlusskriterien festgestellt. Fast alle Patientinnen (99 %) erhielten die verschriebene Dosis im PTV. Grenzdosen und Zeitlimits wurden in 89 % (95 % CI 82 % bis 93 %) eingehalten. 11 unerwünschte Ereignisse wurden bei 10 Patientinnen gemeldet; fünf in Verbindung mit gleichzeitiger endokriner Therapie. In 2 Fällen wurde eine kausale Beziehung zur Strahlentherapie angegeben: Grad-3-Hitzewallungen. Die Lebensqualität blieb unverändert. Die hypofraktionierte Bestrahlung mit simultan-integriertem Boost konnte in dieser multizentrischen Studie in Praxen und Strahlenkliniken problemlos durchgeführt werden. Die Verträglichkeit war in dieser Studie gut.
Working memory and visuospatial deficits correlate with oculomotor control in children with fetal alcohol spectrum disorder

Previous studies have demonstrated that children with Fetal Alcohol Spectrum Disorder (FASD) exhibit deficits in measures of eye movement control that probe aspects of visuospatial processing and working memory. The goal of the present study was to examine, in a large cohort of children with FASD, prenatal alcohol exposure (PAE) but not FASD, and typically developing control children, the relationship between performance in eye movement tasks and standardized psychometric tests that assess visuospatial processing and working memory. Participants for this dataset were drawn from a large, multi-site investigation, and included children and adolescents aged 5-17 years diagnosed with an FASD (n=71), those with PAE but no clinical FASD diagnosis (n=20), and typically developing controls (n=111). Participants completed a neurobehavioral test battery and a series of saccadic eye movement tasks. The FASD group performed worse than controls on the psychometric and eye movement measures of working memory and visuospatial skills. Within the FASD group, digit recall, block recall, and animal sorting were negatively correlated with sequence errors on the memory-guided task, and arrows was negatively correlated with prosaccade endpoint error. There were no significant correlations in the control group. These data suggest that psychometric tests and eye movement control tasks may assess similar domains of cognitive function, and these assessment tools may be measuring overlapping brain regions damaged due to prenatal alcohol exposure. The results of this study demonstrate that eye movement control tasks directly relate to outcome measures obtained with psychometric tests and are able to assess multiple domains of cognition simultaneously, thereby allowing for an efficient and accurate assessment.
Community Integration in the Early Phase of Housing Among Homeless Persons Diagnosed with Severe Mental Illness: Successes and Challenges

The present investigation used qualitative methods to explore the response to housing and experience of community integration of formerly homeless individuals diagnosed with severe mental illness recently housed in both independent and staffed residential settings. Findings indicate that entering into housing after a long period of homelessness is associated with improvements in community integration for most individuals diagnosed with severe mental illness. However, for a meaningful minority, the adaptation to housing may also be associated with challenges that can complicate the integration process. Implications of findings are discussed in the context of how best to tailor programs to meet the complex needs of persons diagnosed with severe mental illness and to maximize community integration.
The Distress Thermometer as an ultra-short screening tool: a first validation study for mixed-cancer outpatients in Singapore.

Research has shown that single-item tools, like the Distress Thermometer (DT), are comparable to longer ones, like the Hospital Anxiety and Depression Scale (HADS). In this study, we tested the validity of the DT in a population of Singapore cancer outpatients, and determined the cut-off scores on the DT for clinically relevant distress and an impaired quality of life (QOL). We also documented the prevalence of anxiety, depression, and QOL impairments in this population.



One hundred and five patients (Mdn age=51-60years, 64% female, and 71% Chinese) diagnosed with various cancers participated in this study. They completed a standard socio-demographic form, the DT and the Problem List, the HADS, and the EuroQOL Quality of Life Scale (EQ-5D).



Almost a third of patients had clinically significant emotional distress, with 15%-16% having probable levels of anxiety and depression. Almost half (41%-55%) had an impaired QOL compared to Singapore population norms. Receiver operating characteristic curve analyses identified an area under the curve of 0.89 (SE=0.36, 95% CI [0.82, 0.96], p<.001) when compared to the HADS cut-off score of 15. A cut-off score of 5 on the DT had the best sensitivity (0.88) and specificity (0.81). Participants above the DT cut-off score of 5 reported significantly more emotional problems (worry, nervousness, depression, sadness), insurance/finance-related problems, and sleep problems. They also scored significantly lower on EQ-5D, with more QOL impairments in the domains of carrying out their usual activities and anxiety/depression.



Levels of distress, anxiety, depression, and QOL impairments are high in this population. The DT was found to be a valid tool for distress screening in the Singapore cancer population, with a recommended cut-off score of 5.
Validity of assessing people experiencing mental illness who have offended using the Camberwell Assessment of Need-Forensic and Health of the Nation Outcome Scales-Secure.

Evidence-based practices for forensic mental health services have been slow to develop, and there is a lack of measures that assess the mental health and criminogenic needs of people experiencing mental illness who have offended. The present study aimed to investigate the interrelationship between a clinician-rated forensic mental health needs assessment (Health of the Nation Outcomes Scales-Secure (HoNOS-S)), a forensic mental health needs assessment that considers both clinician and patient perspectives (Camberwell Assessment of Need-Forensic (CANFOR)), and measures of general and violent recidivism (Level Service-Case Management Inventory (LS-CMI) and HCR-20 Violence Risk Assessment Scheme (HCR-20)). Needs were assessed for 72 forensic patients aged between 20 and 62 years of age, located in a secure forensic mental health facility. The findings revealed significant positive correlations between the HoNOS-S, CANFOR, and HCR-20. Only the CANFOR was positively correlated with the LS-CMI, and uniquely contributed variance to the HCR-20. Patients and nurses differed in the total number of needs and met needs they identified as present. The findings suggest that the collaborative approach of the CANFOR might be more appropriate for measuring outcomes in the treatment of individuals experiencing mental illness who have offended.
Maternal prepregnancy obesity and insulin treatment during pregnancy are independently associated with delayed lactogenesis in women with recent gestational diabetes mellitus.

The timely onset of stage II lactogenesis (OL) is important for successful breastfeeding and newborn health. Several risk factors for delayed OL are common in women with a history of gestational diabetes mellitus (GDM), which may affect their chances for successful breastfeeding outcomes.



We investigated the prevalence and risk factors associated with delayed OL in a racially and ethnically diverse cohort of postpartum women with recent GDM.



We analyzed data collected in the Study of Women, Infant Feeding and Type 2 Diabetes After GDM Pregnancy (SWIFT), which is a prospective cohort of women diagnosed with GDM who delivered at Kaiser Permanente Northern California hospitals from 2008 to 2011. At 6-9 wk postpartum, delayed OL was assessed by maternal report of breast fullness and defined as occurring after 72 h postpartum. We obtained data on prenatal course and postdelivery infant feeding practices from electronic medical records and in-person surveys. We used multivariable logistic regression models to estimate associations of delayed OL with prenatal, delivery, and postnatal characteristics.



The analysis included 883 SWIFT participants who initiated breastfeeding and did not have diabetes at 6-9 wk postpartum. Delayed OL was reported by 33% of women and was associated with prepregnancy obesity (OR: 1.56; 95% CI: 1.07, 2.29), older maternal age (OR: 1.05; 95% CI: 1.01, 1.08), insulin GDM treatment (OR: 3.11; 95% CI: 1.37, 7.05), and suboptimal in-hospital breastfeeding (OR: 1.65; 95% CI: 1.20, 2.26). A higher gestational age was associated with decreased odds of delayed OL but only in multiparous mothers (OR: 0.79; 95% CI: 0.67, 0.94).



One-third of women with recent GDM experienced delayed OL. Maternal obesity, insulin treatment, and suboptimal in-hospital breastfeeding were key risk factors for delayed OL. Early breastfeeding support for GDM women with these risk factors may be needed to ensure successful lactation.
Effects of light-emitting diodes on muscle fatigue and exercise tolerance in patients with COPD: study protocol for a randomized controlled trial

Light-emitting diodes (LED) have been used to minimize muscle fatigue in athletes and healthy subjects. Patients with chronic obstructive pulmonary disease (COPD) are susceptible to early muscle fatigue.



The objective of this study is to investigate the acute effects of LED on muscle function, exercise capacity and cardiorespiratory responses during isometric and dynamic exercise in patients with COPD.



This study will assess 30 patients with moderate to severe obstruction (forced expiratory volume-one second,FEV1 ≤70% predicted). Isometric and dynamic protocols will be conducted in two visits each, for a total of four visits a week apart. First, venous blood will be taken from the patients. The isometric protocol will start with the determination of the maximum voluntary isometric contraction (MIVC) to determine the workload (60% of MIVC) for the isometric endurance test (IET). Patients will be randomized to receive either the placebo or LED application (each point will be irradiated for 30 s and the energy received at each point will be 41.7 J). Immediately after finishing this procedure, the patients will carry out the IET until the limit of tolerance or until a 20% fall of strength is observed. After the test, another blood draw will be taken. In another visit (one week later), the same order of procedures will be performed, except with the opposite (LED or placebo). For the dynamic endurance test (DET), the same procedures described above will be followed, except with 75% of the maximal workload obtained from the incremental cycle ergometer test used instead of the IET. The electromyography will be recorded during the isometric and dynamic protocols. Differences in muscle function, exercise capacity and cardiorespiratory responses between the LED and placebo applications will be analyzed. The therapeutic effects of LED could minimize muscle fatigue in patients with COPD by increasing exercise tolerance.
Short-term therapy with atorvastatin or fenofibrate does not affect plasma ghrelin, resistin or adiponectin levels in type 2 diabetic patients with mixed hyperlipoproteinaemia

Lipid-lowering therapy is associated with reduced cardiovascular risk. The aim of the present study was to investigate whether lipid-lowering therapy might be associated with changes in the concentrations of metabolically important hormone concentrations. We performed a randomised cross-over open-label trial with atorvastatin (10 mg/day) and fenofibrate (200 mg/day), each for 6 weeks separated by a 6-week washout period in 13 patients (5 men, 8 women, age 60.0±6.8 years, body mass index 30.0±3.0 kg/m2) with type 2 diabetes mellitus and mixed hyperlipoproteinaemia. Plasma ghrelin (RIA, Phoenix Pharmaceuticals, Mountain View, CA, USA), adiponectin (ELISA, Biovendor, Heidelberg, Germany) as well as resistin (ELISA, Linco Research, St. Charles, MO, USA) concentrations were measured before and after atorvastatin as well as before and after fenofibrate. Ghrelin (462±84 pg/ml before vs. 464±102 pg/ml after atorvastatin, n.s.; 454±85 pg/ml before vs. 529±266 pg/ml after fenofibrate, n.s.), resistin (24.4±7.4 pg/ml before vs. 23.7±9.1 pg/ml after atorvastatin, n.s.; 23.4±8.2 pg/ml before vs. 19.9±5.5 pg/ml after fenofibrate, n.s.), adiponectin (10.89±5.33 pg/ml before vs. 12.41±5.75 pg/ml after atorvastatin, n.s.; 12.58±9.87 pg/ml before vs. 10.27±5.23 pg/ml after fenofibrate, n.s.) and insulin levels did not change significantly during lipid-lowering therapy. In patients with type 2 diabetes and mixed hyperlipoproteinaemia, short-term atorvastatin as well as fenofibrate therapy had no significant effects on adiponectin, ghrelin or resistin levels.