nils-herrmann/clean_scirepeval huggingface dataset:
Retreatment and maintenance therapy with infliximab in fistulizing Crohn's disease.

Infliximab has clearly demonstrated its efficacy in the short-term treatment of fistulizing Crohn's disease. We present here the results of retreatment and long-term maintenance therapy.



Eighty one consecutive patients with active fistulizing Crohn's disease, in whom previous treatments had failed, were treated with infliximab. All patients received as the initial treatment of 5 mg/kg i.v. infusions (weeks 0, 2, and 6). Those patients who failed to respond after the initial cycle (group 1, n = 25), or those who relapsed after having responded (group 2, n = 13), received retreatment with three similar doses (weeks 0,2, and 6). Those who responded to retreatment were included in a long-term maintenance programme (n = 44), with repeated doses (5 mg/kg i.v. infusions) every eight weeks for 1-2 years.



In the initial treatment 56% of the patients responded partially; this response being complete in 44%. In the retreatment, 28% of group 1 (non-responders) presented a complete response, compared to 77% in group 2 (relapsers) (p < 0.0001). In the maintenance treatment, the global response was 88% (39/44). The mean number of doses per patient was 4.4 +/- 2 (range 1-9) with a duration of 36 +/- 12 weeks (range 8-72). Adverse effects were not significantly increased in either treatment.



Both retreatment and long-term maintenance therapy with infliximab, are highly effective and well tolerated in fistulizing Crohn's disease patients.
A prospective comparison of cardiac rehabilitation enrollment following automatic vs usual referral.

Cardiac rehabilitation remains grossly under-utilized despite its proven benefits. This study prospectively compared verified cardiac rehabilitation enrollment following automatic vs usual referral, postulating that automatic referral would result in significantly greater enrollment for cardiac rehabilitation.



Prospective controlled multi-center study.



A consecutive sample of 661 patients with acute coronary syndrome treated at 2 acute care centers (75% response rate) were recruited, one site with automatic referral via a computerized prompt and the other with a usual referral strategy at the physician's discretion. Cardiac rehabilitation referral was discerned in a mailed survey 9 months later (n = 506; 84% retention), and verified with 24 cardiac rehabilitation sites to which participants were referred.



A total of 124 (52%) participants enrolled in cardiac rehabilitation following automatic referral, vs 84 (32%) following usual referral (p < 0.001). Automatically referred participants were more likely to be referred from an in- patient unit (p < 0.01), and to be referred in a shorter time period (p < 0.001). Logistic regression analyses revealed that, after controlling for sociodemographic characteristics and case-mix, automatically referred participants were significantly more likely to enroll in cardiac rehabilitation (odds ratio = 2.1; 95% confidence interval 1.4-3.3) than controls.



Automatic referral resulted in over 50% verified cardiac rehabilitation enrollment; 2 times more than usual referral. It also significantly reduced utilization delays to less than one month.
Effectiveness of glycyrrhizin for oral lichen planus in patients with chronic HCV infection

Oral lichen planus (OLP), an intractable inflammatory disease characterized by a band-like lymphocytic invasion under the oral mucosa, is frequently associated with hepatitis C virus (HCV) infection. We investigated the effects of glycyrrhizin, which is used to treat chronic liver dysfunction, in nine patients with OLP who were positive for HCV antibody and HCV RNA. A control group, eight patients with OLP who were also positive for HCV antibody and HCV RNA, was given only dental cleaning. Glycyrrhizin (GL) was given intravenously, at a dose of 40ml (0.2% solution) daily, for 4 consecutive weeks. Six (66.7%) of the nine patients given GL improved clinically (P=0.0141 vs non-GL group), suggesting that GL is useful in treating OLP.
Fecal occult blood tests. A cost-effectiveness analysis.

A range of fecal occult blood tests are presently on the market and could potentially be used in population screening programs for the detection of colorectal neoplasms. This paper estimates the relative cost-effectiveness of alternative tests and concludes that the unhydrated Hemoccult II is the most cost-effective. However, the incremental costs per life-year of the HemeSelect test and the rehydrated Hemoccult II test are in line with incremental costs observed in breast cancer and cervical cancer programs.
Signs of deterioration in infants discharged home following congenital heart surgery in the first year of life: a qualitative study

To describe the ways in which parents recognise and make decisions about their child's symptoms following discharge home after congenital heart interventions in the first year of life and their experiences of seeking help.



This was a qualitative study involving semistructured interviews with parents. Twenty-one parents were recruited to the study. Parents all had a child who had congenital heart surgery in their first year of life between September 2009 and October 2013 at one of three UK cardiac centres; the children had either died or were readmitted as an emergency following initial discharge.



Some parents were unable to identify any early warning signs. Others described symptoms of deterioration including changes in feeding and appearance, respiratory distress and subtle behavioural changes that may not be routinely highlighted to parents at discharge. Several barriers to accessing prompt medical assistance were identified including parents feeling that their concerns were not taken seriously, long wait times and lack of protocols at A&E.



Our study highlights behavioural symptoms as being a potentially underemphasised sign of deterioration and identifies a number of barriers to parents accessing support when they are concerned. It is important that parents are encouraged to seek advice at the earliest opportunity and that those health professionals at the front line have access to the information they need in order to respond in an appropriate and timely way. A role for home monitoring was also noted as potentially useful in identifying at risk children who appear clinically well.
EFFECT ON THE DURATION OF MECHANICAL VENTILATION OF IDENTIFYING PATIENTS CAPABLE OF BREATHING SPONTANEOUSLY

A BSTRACT Background Prompt recognition of the reversal of respiratory failure may permit earlier discontinuation of mechanical ventilation, without harm to the patient.  We conducted a randomized, controlled trial in 300 adult patients receiving mechanical ventilation in medical and coronary intensive care units. In the intervention group, patients underwent daily screening of respiratory function by physicians, respiratory therapists, and nurses to identify those possibly capable of breathing spontaneously; successful tests were followed by two-hour trials of spontaneous breathing in those who met the criteria. Physicians were notified when their patients successfully completed the trials of spontaneous breathing. The control subjects had daily screening but no other interventions. In both groups, all clinical decisions, including the decision to discontinue mechanical ventilation, were made by the attending physicians.  Although the 149 patients randomly assigned to the intervention group had more severe disease, they received mechanical ventilation for a median of 4.5 days, as compared with 6 days in the 151 patients in the control group (P 0.003). The median interval between the time a patient met the screening criteria and the discontinuation of mechanical ventilation was one day in the intervention group and three days in the control group (P 0.001). Complications — removal of the breathing tube by the patient, reintubation, tracheostomy, and mechanical ventilation for more than 21 days — occurred in 20 percent of the intervention group and 41 percent of the control group (P 0.001). The number of days of intensive care and hospital care was similar in the two groups. Total costs for the intensive care unit were lower in the intervention group (median, $15,740, vs. $20,890 in the controls; P 0.03); hospital costs were lower, though not significantly so (median, $26,229 and $29,048, respectively; P 0.3).  Daily screening of the respiratory function of adults receiving mechanical ventilation, followed by trials of spontaneous breathing in appropriate patients and notification of their physicians when the trials were successful, can reduce the duration of mechanical ventilation and the cost of intensive care and is associated with fewer complications than usual care. ( 1996;335:1864-9.
Factors influencing physicians' detection of cancer patients' and relatives' distress: can a communication skills training program improve physicians' detection?

This study aimed to assess the impact on physicians' detection of patients' and relatives' distress of six 3-h consolidation workshops (CW) following a 2.5-day communication skills basic training (BT) program and to investigate factors associated with detection of distress.



Physicians, after BT, were randomized to CW or to a waiting list. Physicians' detection of patients' and relatives' distress was measured through differences between physicians' ratings of patients' and relatives' distress (VAS) and patients' and relatives' self-reported distress (HADS). Communication skills were analysed according to the CRCWEM.



Mixed-effects modelling of physicians' detection of patients' distress showed a positive group by time effect in favour of physicians in the CW group. Detection of patients' distress was associated negatively with patients' distress, positively with physicians' concurrent use of psychological assessment and supportive skills, and negatively with general assessment skills. Mixed-effects modelling of physicians' detection of relatives' distress showed no significant group by time effect. Detection of relatives' distress was associated negatively with relatives' distress and with general assessment skills.



CW following a 2.5-day BT are needed to improve physicians' detection of patients' distress in three-person interviews. Results indicate the need to further improve physicians' detection of relatives' distress.
A microdialysis study of oral vigabatrin administration in head injury patients: preliminary evaluation of multimodality monitoring.

We assessed the feasibility of administering a neuroprotective drug, vigabatrin (VGB; gamma-vinyl-gamma-aminobutyric acid) with multimodality monitoring, including cerebral microdialysis, in severe head injury patients, to measure surrogate endpoints and blood-brain barrier (BBB) penetration.



Patients (n = 20) were randomised to VGB (0.5 g twice-daily, enteric) or control. ICP, ABP, CPP and cerebrovascular pressure reactivity index (PRx) were monitored. Microdialysate glucose, lactate, pyruvate, glutamate, glycerol, amino acids, VGB and GABA were analysed.



Preliminary evaluation of results (five VGB-treated patients) showed that VGB levels rose in brain microdialysates, followed by a modest increase in GABA. VGB and GABA increased more in abnormal brain than in sites further from lesions, and were higher after multiple VGB doses. Highest VGB and GABA microdialysate levels were 75 and 4 μmol/L respectively. Microdialysate glucose and glycerol sometimes decreased, and glutamate and tyrosine sometimes increased, following VBG administration; causation unproven. VGB did not overtly affect ICP, ABP, CPP, PRx, or microdialysate lactate, pyruvate and lactate/pyruvate ratio.



Multimodality monitoring, including cerebral microdialysis, is feasible for studying surrogate endpoints following drug administration. VGB crosses the BBB, leading to modest increases in extracellular GABA. Further analyses are ongoing. Microdialysis may assist the development of neuroprotective agents by determining penetration into extracellular fluid of the brain.
Evaluating an implementation strategy in cardiovascular prevention to improve prescribing of statins in Germany: an intention to treat analysis

The prescription of statins is an evidence-based treatment to reduce the risk of cardiovascular events in patients with elevated cardiovascular risk or with a cardiovascular disorder (CVD). In spite of this, many of these patients do not receive statins.



We evaluated the impact of a brief educational intervention in cardiovascular prevention in primary care physicians' prescribing behaviour regarding statins beyond their participation in a randomised controlled trial (RCT). For this, prescribing data of all patients > 35 years who were counselled before and after the study period were analysed (each n > 75,000). Outcome measure was prescription of Hydroxymethylglutaryl-CoA Reductase Inhibitors (statins) corresponding to patients' overall risk for CVD. Appropriateness of prescribing was examined according to different risk groups based on the Anatomical Therapeutic Chemical Classification System (ATC codes).



There was no consistent association between group allocation and statin prescription controlling for risk status in each risk group before and after study participation. However, we found a change to more significant drug configurations predicting the prescription of statins in the intervention group, which can be regarded as a small intervention effect.



Our results suggest that an active implementation of a brief evidence-based educational intervention does not lead to prescription modifications in everyday practice. Physician's prescribing behaviour is affected by an established health care system, which is not easy to change.
Efficacy of a brief manualized intervention Managing Cancer and Living Meaningfully (CALM) adapted to German cancer care settings: study protocol for a randomized controlled trial

Although psycho-oncological interventions have been shown to significantly reduce symptoms of anxiety and depression and enhance quality of life, a substantial number of patients with advanced cancer do not receive psycho-oncological interventions tailored to their individual situation. Given the lack of reliable data on the efficacy of psycho-oncological interventions in palliative care settings, we aim to examine the efficacy of a brief, manualized individual psychotherapy for patients with advanced cancer: Managing Cancer and Living Meaningfully (CALM). CALM aims to reduce depression and death anxiety, to strengthen communication with health care providers, and to enhance hope and meaning in life. We adapted the intervention for German cancer care settings. We use a single-blinded randomized-controlled trial design with two treatment conditions: intervention group (IG, CALM) and control group (CG). Patients in the CG receive a usual non-manualized supportive psycho-oncological intervention (SPI). Patients are randomized between the IG and CG and assessed at baseline (t0), after three (t1) and after 6 months (t2). We include patients with a malignant solid tumor who have tumor stages of III or IV (UICC classification). Patients who are included in the study are at least 18 years old, speak German fluently, score greater than or equal to nine on the PHQ-9 or/and greater than or equal to five on the Distress Thermometer. It is further necessary that there is no evidence of severe cognitive impairments. We measure depression, anxiety, distress, quality of life, demoralization, symptom distress, fatigue as well as spiritual well-being, posttraumatic growth and close relationship experiences using validated questionnaires. We hypothesize that patients in the IG will show a significantly lower level of depression 6 months after baseline compared to patients in the CG. We further hypothesize a significant reduction in anxiety and fatigue as well as significant improvements in psychological and spiritual well-being, meaning and post-traumatic growth in the IG compared to CG 6 months after baseline. Our study will contribute important statistical evidence on whether CALM can reduce depression and existential distress in a German sample of advanced and highly distressed cancer patients.
Immediate versus deferred empirical antifungal (IDEA) therapy in high-risk patients with febrile neutropenia: a randomized, double-blind, placebo-controlled, multicenter study

Empirical antifungal therapy is widely used in high-risk neutropenic hematology patients with fever persisting for more than 4 days. This clinical trial assessed whether immediate empirical therapy with voriconazole could lower the rates of invasive fungal infections (IFIs) compared with this approach. In a double-blind, placebo-controlled, multicenter study, patients with acute leukemia undergoing chemotherapy or allogeneic hematopoietic stem cell transplantation (HSCT) recipients were randomized to broad-spectrum antibacterial therapy plus voriconazole (immediate) or placebo (deferred) after the onset of neutropenic fever. If fever persisted for 96 h, patients were switched to open-label intravenous voriconazole; oral treatment was permitted after 96 h. The primary endpoint was the rate of proven/probable IFIs between Days 2 and 28 after fever onset in the modified intent-to-treat (mITT) complete-case population. One hundred and forty-seven patients were randomized to immediate (n = 81) or deferred (n = 66) voriconazole. In the mITT population, six patients in the immediate group and nine in the deferred group developed proven/probable IFI between Days 2 and 28 (p = 0.258). The safety profiles were similar in both groups. While immediate empirical therapy with voriconazole appears to be safe in febrile neutropenic high-risk patients, it was not associated with a significant reduction in IFIs compared with therapy deferred for 96 h after fever onset.
Insulin like growth factor-I , insulin like growth factor binding protein-I , and insulin in childhood Crohn ' s disease

Twenty nine children with Crohn's disease were studied before and after treatment with steroids or an elemental diet to assess the effect of disease activity and treatment on serum insulin like growth factor I (IGF-I), insulin like growth factor binding protein (IGFBP-1), and insulin concentrations. The median serum IGF-I concentration was lower in patients with active disease than in matched controls, and lower in stunted than well grown patients, but insulin and IGFBP-1 concentrations were not significantly different between any group. After four weeks of either treatment there was an increase in the median serum IGF-I concentration; this was greater in the steroid group than the elemental diet group. The median serum insulin concentration increased and median serum IGFBP-1 concentration decreased in the steroid treated group but not in the elemental diet group. These changes were accompanied by a greater and more sustained increase in energy intake in the steroid group. Despite this the median height velocity SD score was greater in the elemental diet group than in the steroid group. (Gut 1993; 34: 944-947) Department of Gastroenterology, Booth Hall Children's Hospital, Charlestown Road, Blackley, Manchester M9 2AA A G Thomas F Taylor V Miller Department of Chemical Endocrinology, St Bartholomew's Hospital, London
Association between corticosteroids and infection, sepsis, and infectious death in pediatric acute myeloid leukemia (AML): results from the Canadian infections in AML research group.

Infection continues to be a major problem for children with acute myeloid leukemia (AML). Objectives were to identify factors associated with infection, sepsis, and infectious deaths in children with newly diagnosed AML.



We conducted a retrospective, population-based cohort study that included children ≤ 18 years of age with de novo, non-M3 AML diagnosed between January 1995 and December 2004, treated at 15 Canadian centers. Patients were monitored for infection from initiation of AML treatment until recovery from the last cycle of chemotherapy, conditioning for hematopoietic stem cell transplantation, relapse, persistent disease, or death (whichever occurred first). Consistent trained research associates abstracted all information from each site.



341 patients were included. Median age was 7.1 years (interquartile range [IQR], 2.0-13.5) and 29 (8.5%) had Down syndrome. In sum, 26 (7.6%) experienced death as a first event. There were 1277 courses of chemotherapy administered in which sterile site microbiologically documented infection occurred in 313 courses (24.5%). Sepsis and infectious death occurred in 97 (7.6%) and 16 (1.3%) courses, respectively. The median days of corticosteroid administration was 2 per course (IQR, 0-6). In multiple regression analysis, duration of corticosteroid exposure was significantly associated with more microbiologically documented sterile site infection, bacteremia, fungal infection, and sepsis. The only factor significantly associated with infectious death was days of corticosteroid exposure (odds ratio, 1.05; 95% confidence interval, 1.02-1.08; P = .001).



In pediatric AML, infection, sepsis, and infectious death were associated with duration of corticosteroid exposure. Corticosteroids should be avoided when possible for this population.
Chronomodulated irinotecan, oxaliplatin, and leucovorin-modulated 5-Fluorouracil as ambulatory salvage therapy in patients with irinotecan- and oxaliplatin-resistant metastatic colorectal cancer.

To evaluate the activity and tolerability of salvage chronomodulated chemotherapy combining irinotecan (I), 5-fluorouracil/leucovorin (5-FU/LV), and oxaliplatin (O) (chronoIFLO) in patients with metastatic colorectal cancer (MCRC) and prior progression on four drugs.



Seventy-seven nonhospitalized MCRC patients received chronoIFLO every 3 weeks, with day 1: I (180 mg/m2 over 6 hours, with peak infusion rate at 05:00) and days 2-5: 5-FU/LV (700/300 mg/m2 per day over 12 hours, with peak flow rate at 04:00), and O (20 mg/m2 per day over 12 hours, with peak flow rate at 16:00). Toxicity and response were assessed every 3 weeks and every 2 months, respectively.  Three or more prior chemotherapy lines were given to 75% of the patients. Two or more organs had metastatic disease in 65% of the patients. A median number of six courses of chronoIFLO was given. The main grade 3-4 toxicities were diarrhea (39% of the patients, 9% of the courses) and neutropenia (30% of the patients and 7% of the courses). Grade 3 peripheral sensory neuropathy occurred in 14% of the patients. Two patients achieved a partial response and 61 had stable disease, resulting in disease control for 82% of the patients. The median time to progression (TTP) was 5.5 months (95% confidence interval, 3.7-6.0). The median overall survival time was 14.2 months (9.8-17.3). Baseline performance status, serum carcinoembryonic antigen (CEA) level, and CEA doubling time were independent prognostic factors of TTP.



ChronoIFLO safely and durably halted tumor progression in most extensively pretreated MCRC patients.