nils-herrmann/clean_scirepeval huggingface dataset:
Efficacy of confrontational counselling for smoking cessation in smokers with previously undiagnosed mild to moderate airflow limitation: study protocol of a randomized controlled trial

The use of spirometry for early detection of chronic obstructive pulmonary disease (COPD) is still an issue of debate, particularly because of a lack of convincing evidence that spirometry has an added positive effect on smoking cessation. We hypothesise that early detection of COPD and confrontation with spirometry for smoking cessation may be effective when applying an approach we have termed "confrontational counselling"; a patient-centred approach which involves specific communication skills and elements of cognitive therapy. An important aspect is to confront the smoker with his/her airflow limitation during the counselling sessions. The primary objective of this study is to test the efficacy of confrontational counselling in comparison to regular health education and promotion for smoking cessation delivered by specialized respiratory nurses in current smokers with previously undiagnosed mild to moderate airflow limitation.



The study design is a randomized controlled trial comparing confrontational counselling delivered by a respiratory nurse combined with nortriptyline for smoking cessation (experimental group), health education and promotion delivered by a respiratory nurse combined with nortriptyline for smoking cessation (control group 1), and "care as usual" delivered by the GP (control group 2). Early detection of smokers with mild to moderate airflow limitation is achieved by means of a telephone interview in combination with spirometry. Due to a comparable baseline risk of airflow limitation and motivation to quit smoking, and because of the standardization of number, duration, and scheduling of counselling sessions between the experimental group and control group 1, the study enables to assess the "net" effect of confrontational counselling. The study has been ethically approved and registered.



Ethical as well as methodological considerations of the study are discussed in this protocol. A significant and relevant effect of confrontational counselling would provide an argument in favour of early detection of current smokers with airflow limitation. Successful treatment of tobacco dependence in respiratory patients requires repeated intensive interventions. The results of this study may also show that respiratory nurses are able to deliver this treatment and that intensive smoking cessation counselling is more feasible.
Employing a Multi-level Approach to Recruit a Representative Sample of Women with Recent Gestational Diabetes Mellitus into a Randomized Lifestyle Intervention Trial

The postpartum period is a window of opportunity for diabetes prevention in women with recent gestational diabetes (GDM), but recruitment for clinical trials during this period of life is a major challenge.  We adapted a social-ecologic model to develop a multi-level recruitment strategy at the macro (high or institutional level), meso (mid or provider level), and micro (individual) levels. Our goal was to recruit 100 women with recent GDM into the Balance after Baby randomized controlled trial over a 17-month period. Participants were asked to attend three in-person study visits at 6 weeks, 6, and 12 months postpartum. They were randomized into a control arm or a web-based intervention arm at the end of the baseline visit at six weeks postpartum. At the end of the recruitment period, we compared population characteristics of our enrolled subjects to the entire population of women with GDM delivering at Brigham and Women’s Hospital (BWH).  We successfully recruited 107 of 156 (69 %) women assessed for eligibility, with the majority (92) recruited during pregnancy at a mean 30 (SD ± 5) weeks of gestation, and 15 recruited postpartum, at a mean 2 (SD ± 3) weeks postpartum. 78 subjects attended the initial baseline visit, and 75 subjects were randomized into the trial at a mean 7 (SD ± 2) weeks postpartum. The recruited subjects were similar in age and race/ethnicity to the total population of 538 GDM deliveries at BWH over the 17-month recruitment period.  Our multilevel approach allowed us to successfully meet our recruitment goal and recruit a representative sample of women with recent GDM. We believe that our most successful strategies included using a dedicated in-person recruiter, integrating recruitment into clinical flow, allowing for flexibility in recruitment, minimizing barriers to participation, and using an opt-out strategy with providers. Although the majority of women were recruited while pregnant, women recruited in the early postpartum period were more likely to present for the first study visit. Given the increased challenges of recruiting postpartum women with GDM into research studies, we believe our findings will be useful to other investigators seeking to study this population.
Double-blind comparison of fluoxetine and nortriptyline in the treatment of moderate to severe major depression.

Depression is an international public health problem. Impairment in social and occupational functioning, increased comorbidity with other psychiatric and medical conditions, and an increased risk of mortality are a few of its consequences. Some psychiatrists have the impression that selective serotonin re-uptake inhibitors may not work as well as tricyclic anti-depressants in severe depression and/or melancholia. On the contrary, there is a general belief that selective serotonin re-uptake inhibitors are superior to the tricyclic anti-depressants in having fewer side-effects, particularly cardiovascular effects. The objective of this double-blind study was to compare the efficacy and safety of fluoxetine and nortriptyline in patients with moderate to severe major depression.



A total of 48 adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM IV), forth edition for major depression, based on the structured clinical interview for DSM IV participated in the trial. Patients had a baseline Hamilton Rating Scale for Depression score of at least 20. In this double-blind, single-center trial, patients were randomly assigned to receive nortriptyline 150 mg/day (group 1) or fluoxetine 60 mg/day (group 2) for 6-weeks. The outcome of the two groups was assessed using Hamilton Depression Rating Scale, a side-effect checklist and a regular ECG assessment.



The results suggest that the efficacy of nortriptyline is superior to fluoxetine in this group of major depressed patients. No significant differences were observed between dropout rates in the two groups but anti-cholinergic side-effects were significantly more frequent with nortriptyline than with fluoxetine but there was no significant difference in cardiovascular effects in particular QTc prolongation.



The results of the current study suggest that nortriptyline was more effective than fluoxetine in the treatment of moderate to severe depression. A larger study is warranted.
C1-inhibitor autoantibodies in SLE.

The presence of anti-C1-inhibitor (anti-C1-INH) autoantibodies is a hallmark of acquired C1-inhibitor deficiency. However, only scarce data are available on their prevalence, diagnostic value, and/or significance in systemic lupus erythematosus (SLE). In a multicentre study, we determined the levels of autoantibodies to C1-inhibitor in sera from 202 patients with SLE and 134 healthy controls. Additional clinical and laboratory parameters, such as organ involvement, as well as anti-C1q, anti-double-stranded DNA antibody, erythrocyte sedimentation rate, C-reactive protein, C3 and C4 serum complement levels have been studied in patients. The level of anti-C1-INH IgG was significantly higher (p = 0.034) in SLE patients, than in the controls. A high anti-C1-INH level of > or =0.4 U/ml (mean of controls + 2 SD) was found in 17% of the patients, but in only 4% of the controls (p = 0.0003). The SLEDAI score was significantly higher (p = 0.048) and the duration of SLE was significantly longer (p = 0.0004) among patients with elevated anti-C1-INH levels compared with patients without this autoantibody (median disease duration 8 vs. 17 years, respectively). Anti-C1-INH level was not correlated with any other laboratory parameter or organ manifestation of the disease. These findings indicate that the anti-C1-INH level is higher in SLE patients than in healthy controls and furthermore, the anti-C1-INH level correlates with the duration and activity of the disease.
Double-blind, placebo-controlled, proof-of-concept trial of bexarotene in moderate Alzheimer’s disease

We assessed the impact of retinoid X receptor (RXR) agonist bexarotene on brain amyloid measured by amyloid imaging in patients with Alzheimer’s disease (AD) in a proof-of-concept trial. Twenty patients with AD [Mini Mental State Examination (MMSE) score 10–20 inclusive] with positive florbetapir scans were randomized to receive 300 mg of bexarotene or placebo for 4 weeks. The amyloid imaging result was the primary outcome. Whole-population analyses and prespecified analyses by genotype [apolipoprotein E ε4 (ApoE4) carriers and ApoE4 noncarriers] were conducted. Secondary outcomes included scores on the Alzheimer’s Disease Assessment Scale–Cognitive subscale, Alzheimer’s Disease Cooperative Study–Activities of Daily Living scale, MMSE, Clinical Dementia Rating scale, and Neuropsychiatric Inventory. Serum amyloid-β (Aβ) peptide sequences Aβ1–40 and Aβ1–42 measurements were collected as biomarker outcomes. There was no change in the composite or regional amyloid burden when all patients were included in the analysis. ApoE4 noncarriers showed a significant reduction in brain amyloid on the composite measure in five of six regional measurements. No change in amyloid burden was observed in ApoE4 carriers. There was a significant association between increased serum Aβ1–42 and reductions in brain amyloid in ApoE4 noncarriers (not in carriers). There were significant elevations in serum triglycerides in bexarotene-treated patients. There was no consistent change in any clinical measure. The primary outcome of this trial was negative. The data suggest that bexarotene reduced brain amyloid and increased serum Aβ1–42 in ApoE4 noncarriers. Elevated triglycerides could represent a cardiovascular risk, and bexarotene should not be administered outside a research setting. RXR agonists warrant further investigations as AD therapies.
Stepped care vs. matched care for mood and anxiety disorders: a randomized trial in routine practice.

The effectiveness of two versions of stepped care [with either brief therapy (BT) or cognitive behavioural therapy (CBT) as a first step] is studied in comparison with the traditional matched care approach (CAU) for patients with mood and anxiety disorders.



A randomized trial was performed in routine mental health care in 12 settings, including 702 patients. Patients were interviewed once in 3 months for 18-24 months (response rate 69%).



Overall, patients' health improved significantly over time: 51% had achieved recovery from the DSM-IV disorder(s) after 1 year and 66% at the end of the study. Respectively, 50% and 60% had 'normal' SCL90 and SF36 scores. Cognitive behavioural therapy and BT patients achieved recovery more often than CAU patients (ORs between 1.26 and 1.48), although these results were not statistically significant.



Stepped care, with BT or CBT as a first step, is at least as effective as matched care.
Insulin analogue therapy improves quality of life in patients with type 2 diabetes in India: the A1chieve study.

To determine the effects on quality of life after starting insulin with, or switching to, insulin analogue therapies in Indians with type 2 diabetes mellitus in the 24-week, prospective, observational A1chieve study.



Health-related quality of life (HRQoL) was assessed at baseline and at 24 weeks by the validated EQ-5D questionnaire (visual analogue score [VAS] and five dimensions) in 20,554 people who had started using basal insulin detemir, mealtime insulin aspart (with or without a basal insulin) or biphasic insulin aspart 30.



Quality of life improved in both insulin-naive and insulin experienced patients in all treatment groups. At the start of the study, 63.2% of the insulin-naive patients reported problems with walking but after 24 weeks, only 15.2% reported difficulties. At baseline all HrQOL parameters were deteriorated in Indian cohort and the improvement observed was highly significant and well appreciated. The improvement was seen across all insulin regimen and all regions around India.



Compared with baseline scores, HRQoL improvement was seen after 24 weeks of treatment with all insulin analogue therapies
A randomized controlled trial of tai chi for long-term low back pain (TAI CHI): Study rationale, design, and methods

Low back pain persisting for longer than 3 months is a common and costly condition for which many current treatments have low-moderate success rates at best. Exercise is among the more successful treatments for this condition, however, the type and dosage of exercise that elicits the best results is not clearly defined. Tai chi is a gentle form of low intensity exercise that uses controlled movements in combination with relaxation techniques and is currently used as a safe form of exercise for people suffering from other chronic pain conditions such as arthritis. To date, there has been no scientific evaluation of tai chi as an intervention for people with back pain. Thus the aim of this study will be to examine the effects of a tai chi exercise program on pain and disability in people with long-term low back pain.



The study will recruit 160 healthy individuals from the community setting to be randomised to either a tai chi intervention group or a wait-list control group. Individuals in the tai chi group will attend 2 tai chi sessions (40 minutes)/week for 8 weeks followed by 1 tai chi session/week for 2 weeks. The wait-list control will continue their usual health care practices and have the opportunity to participate in the tai chi program once they have completed the follow-up assessments. The primary outcome will be bothersomeness of back symptoms measured with a 0-10 numerical rating scale. Secondary outcomes include, self-reports of pain-related disability, health-related quality of life and global perceived effect of treatment. Statistical analysis of primary and secondary outcomes will be based on the intention to treat principle. Linear mixed models will be used to test for the effect of treatment on outcome at 10 weeks follow up. This trial has received ethics approval from The University of Sydney Human Research Ethics Committee. HREC Approval No.10452



This study will be the first trial in this area and the information on its effectiveness will allow patients, clinicians and treatment funders to make informed choices regarding this treatment.
Validation of the Comprehensive International Classification of Functioning, Disability, and Health Core Set for multiple sclerosis from the perspective of physicians

The Comprehensive International Classification of Functioning, Disability and Health (ICF) Core Set for multiple sclerosis (MS) is an application of the ICF to describe the typical spectrum of functioning in people with MS. The objective of this study was to validate the Comprehensive ICF Core Set for MS from the perspective of physicians. Using a three-round Delphi technique, physicians experienced in the MS treatment were requested to name patients’ problems, resources, and aspects of environment. The statements of the first Delphi round were linked to ICF categories based on established linking rules. These categories as well as the results of the second round were reported back to the participants. Eighty-four physicians participated in the study. Totally, 89 categories (64.5%) of the Comprehensive ICF Core Set for MS were confirmed by the participants. Eight ICF categories, which are currently not included in the ICF Core Set, were identified. The validity of the Comprehensive ICF Core Set for MS was largely affirmed by the physicians. However, some additional categories were named, which should be further discussed regarding a revised version of the Comprehensive ICF Core Set for MS.
Calcium Absorption from Fortified Ice Cream Formulations Compared with Calcium Absorption from Milk

Optimal bone mass in early adulthood is achieved through appropriate diet and lifestyle, thereby protecting against osteoporosis and risk of bone fracture in later life. Calcium and vitamin D are essential to build adequate bones, but calcium intakes of many population groups do not meet dietary reference values. In addition, changes in dietary patterns are exacerbating the problem, thereby emphasizing the important role of calcium-rich food products. We have designed a calcium-fortified ice cream formulation that is lower in fat than regular ice cream and could provide a useful source of additional dietary calcium. Calcium absorption from two different ice cream formulations was determined in young adults and compared with milk.



Sixteen healthy volunteers (25 to 45 years of age), recruited from the general public of The Netherlands, participated in a randomized, reference-controlled, double-blind cross-over study in which two test products and milk were consumed with a light standard breakfast on three separate occasions: a standard portion of ice cream (60 g) fortified with milk minerals and containing a low level (3%) of butter fat, ice cream (60 g) fortified with milk minerals and containing a typical level (9%) of coconut oil, and reduced-fat milk (1.7% milk fat) (200 mL). Calcium absorption was measured by the dual-label stable isotope technique.



Effects on calcium absorption were evaluated by analysis of variance.



Fractional absorption of calcium from the 3% butterfat ice cream, 9% coconut oil ice cream, and milk was 26%+/-8%, 28%+/-5%, and 31%+/-9%, respectively, and did not differ significantly (P=0.159).



Results indicate that calcium bioavailability in the two calcium-fortified ice cream formulations used in this study is as high as milk, indicating that ice cream may be a good vehicle for delivery of calcium.
The Effect of Sitting on Stability Balls on Nonspecific Lower Back Pain, Disability, and Core Endurance: A Randomized Controlled Crossover Study.

Experimental randomized crossover.



The aim of the study was to determine whether sitting on a ball for 90 min/d instead of a chair has an effect on low back pain (LBP), low back disability, and/or core muscle endurance.



LBP may result from prolonged sitting. It has been proposed that replacing chairs with stability balls can diminish LBP in those who sit for prolonged periods. Research on the topic is sparse and inconclusive.



A total of 90 subjects (university students, staff, and faculty, ages 18-65, who sit ≥4 hr/d) were randomly assigned to the intervention or control group for the first part of the study. Baseline data were collected: Oswestry Disability Index, a numerical pain rating scale for LBP, and four core muscle endurance tests. For 8 weeks, the control group sat on their usual chair. The intervention group sat on stability balls 5 d/wk, increasing up to 90 min/d. Baseline measurements were repeated postintervention. After a washout period, subjects switched groups, and the procedures were repeated-70 completed participation in control group and 76 in intervention group.



There were no statistically significant differences for pain or disability in either group (P > 0.05). Changes in isometric trunk flexion (P = 0.001), nondominant side plank (P = 0.008), and Sorensen (P = 0.006) endurance scores were significant within the intervention group but not the control group. Between-group comparisons revealed a significant difference for isometric trunk flexion (P = 0.005) and Sorensen endurance times (P = 0.010). Analysis also showed that ball-sitting did not prevent an increase in LBP over the 8-week period.



Ball-sitting had no significant effects on LBP or associated disability, but did improve core endurance in the sagittal plane. Although ball-sitting may be useful as an adjunct treatment for LBP when core muscles are involved, clinicians should rely on other, evidence-based treatments for LBP.
A phase I study of flavopiridol in combination with gemcitabine and irinotecan in patients with metastatic cancer.

Flavopiridol (HMR 1275) is a synthetic flavone with antineoplastic properties through inhibition of cyclin-dependent kinase inhibitor. Flavopiridol synergizes in a sequence-dependent fashion with chemotherapy. Major adverse events of flavopiridol in single agent phase I studies are secretory diarrhea, neutropenia, thrombosis, and fatigue.



Patients with advanced solid tumors were treated with gemcitabine 800 mg/m and irinotecan 80 mg/m on day 1, followed by flavopiridol, starting dose of 30 mg/m on day 2 with increment of 15 mg/m per dose level, repeated on days 8 and 9 for the first 6 patients (3-week cycle), and then repeated on days 15 and 16 for the remainder patients (4-week cycle). The protocol had to be amended for inability to redose after 1 week.



Fourteen women and 7 men with advanced solid tumors were enrolled. The median age was 51 years and the median number of prior chemotherapies was 3 (0-9). Neutropenic sepsis (1 patient), grade 3 diarrhea (1 patient), and neutropenia (2 patients) preventing retreatment on day 8 were observed among the 6 subjects treated on the first schedule. The recommended phase II dose of flavopiridol was 45 mg/m in combination with irinotecan and gemcitabine every 2 weeks. Dose-limiting toxicities were electrolyte imbalance with fatigue (1 patient), and renal failure and dyspnea with hypoxia (1 patient each), seen at 45 and 60 mg/m doses, respectively. The most common side effects were fatigue (81%), nausea (71%), diarrhea (67%), transient myelosuppression (43%), and vomiting (24%).



The every 2 week dosing is well tolerated with a phase II recommended dose of 45 mg/m of flavopiridol in combination with irinotecan (80 mg/m) and gemcitabine (800 mg/m).
Belotecan, new camptothecin analogue, is active in patients with small-cell lung cancer: results of a multicenter early phase II study.

Belotecan (Camtobell, Chong Keun Dang Corp, Seoul, Korea; CKD602) is a new camptothecin analogue. This study aimed to investigate the safety and efficacy of single-agent belotecan for small-cell lung cancer (SCLC).



Twenty-seven patients with chemotherapy-naive or chemosensitive SCLC were treated with belotecan 0.5 mg/m(2)/day on days 1-5 of a 3-week cycle. All 27 patients were assessable for toxicity, and 21 patients assessable for response.



Nine patients (42.9%) showed objective tumor responses including one complete response; seven (63.6%) in 11 chemotherapy-naive patients; and two (20.0%) in 10 chemosensitive patients. With a median follow-up of 5 years, median progression-free and survival time for chemotherapy-naive patients were 4.8 months and 11.9 months, respectively, while the corresponding values for chemosensitive patients were 3.3 months and 10.5 months, respectively. The most common toxicity was neutropenia.



Belotecan was active in SCLC patients as a single agent, warranting further investigations of belotecan in combination with platinum or other active agents.