nils-herrmann/clean_scirepeval huggingface dataset:
Evaluation of Efficacy and Safety of Fixed Dose Lovastatin and NiacinER Combination in Asian Indian Dyslipidemic Patients: A Multicentric Study

Asian Indian dyslipidemia is characterized by: borderline high low-density lipoprotein (LDL) cholesterol and apolipoprotein (apo) B; high triglycerides, low high-density lipoprotein (HDL) cholesterol and apoA1; and high lipoprotein(a) (lp[a]). We performed a controlled multicentric trial in India to evaluate the efficacy and safety of a fixed dose combination of lovastatin and niacin extended release (niacin(ER)) formulation in patients with moderate to severe dyslipidemia. Consecutive subjects that satisfied the selection criteria, agreed to an informed consent, and with no baseline presence of liver/renal disease or heart failure were enrolled in the study. After a 4-week run-in period there were 142 patients with LDL levels > or = 130 mg/dL. Eleven patients were excluded because of uncontrolled hyperglycemia and 131 patients were recruited. After baseline evaluation of clinical and biochemical parameters all subjects were administered lovastatin (20 mg) and niacin(ER) (500 mg) combination once daily. Dose escalation was done on basis of lipid parameters at 8 weeks and in 11 patients increased to lovastatin (20 mg) and niacin(ER) (1000 mg). An intention-to-treat analysis was performed and data was analyzed using nonparametric Wilcoxon signed rank test. Thirteen patients (10%) were lost to follow-up and 4 (3%) withdrew because of dermatological adverse effects: flushing, pruritus, and rash. The mean values of various lipid parameters (mg/dL) at baseline, and at weeks 4, 12, and 24 respectively were: total cholesterol 233.9 +/- 27, 206.3 +/- 27, 189.8 +/- 31, and 174.9 +/- 27 mg/dL; LDL cholesterol 153.4 +/- 22, 127.3 +/- 21, 109.2 +/- 27, and 95.1 +/- 23 mg/dL; triglycerides 171.1 +/- 72, 159.5 +/- 75, 149.2 +/- 45, and 135.2 +/- 40 mg/dL; HDL cholesterol 45.6 +/- 7, 48.9 +/- 7, 51.6 +/- 9, and 53.9 +/- 10 mg/dL; lp(a) 48.5 +/- 26, 40.1 +/- 21, 35.4 +/- 21, and 26.9 +/- 19 mg/dL; and apoA1/apoB ratio 0.96 +/- 0.7, 1.04 +/- 0.4, 1.17 +/- 0.5, and 1.45 +/- 0.5 (p < 0.01). The percentage of decline in various lipids at 4, 12, and 24 weeks was: total cholesterol 11.8%, 18.8%, and 25.2%; LDL cholesterol 17.0%, 28.8%, and 38.0%; triglyceride 6.8%, 12.8%, and 21.0%; lp(a) 17.5%, 26.9%, and 44.5% respectively (p < 0.01). HDL cholesterol and apoA1/apoB increased by 7.2%, 13.1%, and 18.2%; and 7.9%, 21.9%, and 51.6% respectively (p < 0.01). Target LDL levels (< 100 mg/dL in subjects with manifest coronary heart disease or diabetes; < 130 mg/dL in subjects with > 2 risk factors) were achieved in 92 (80.7%) patients. No significant changes were observed in systolic or diastolic blood pressure, blood creatinine, transaminases, or creatine kinase. A fixed dose combination of lovastatin and niacin(ER) significantly improved cholesterol lipoprotein lipids as well as lp(a) and apoA1/apoB levels in Asian Indian dyslipidemic patients. Satisfactory safety and tolerability profile in this population was also demonstrated.
Cardiac surgery is successful in heart transplant recipients.

Improved survival of heart transplant (HTx) recipients and increased acceptance of higher risk donors allows development of late pathology. However, there are few data to guide surgical options. We evaluated short-term outcomes and mortality to guide pre-operative assessment, planning, and post-operative care.



Single centre, retrospective review of 912 patients who underwent HTx from February 1984 - June 2012, identified 22 patients who underwent subsequent cardiac surgery. Data are presented as median (IQR).



Indications for surgery were coronary allograft vasculopathy (CAV) (n=10), valvular disease (n=6), infection (n=3), ascending aortic aneurysm (n=1), and constrictive pericarditis (n=2). There was one intraoperative death (myocardial infarction). Hospital stay was 10 (8-21) days. Four patients (18%) returned to theatre for complications. After cardiac surgery, survival at one, five and 10 years was 91±6%, 79±10% and 59±15% with a follow-up of 4.6 (1.7-10.2) years. High pre-operative creatinine was a univariate risk factor for mortality, HR=1.028, (95%CI 1.00-1.056; p=0.05). A time dependent Cox proportional hazards model of the risk of cardiac surgery post-HTx showed no significant hazard; HR=0.87 (95%CI 0.37-2.00; p=0.74).



Our experience shows cardiac surgery post-HTx is associated with low mortality, and confirms that cardiac surgery is appropriate for selected HTx recipients.
Prognostic value of variables derived from the six-minute walk test in patients with COPD: Results from the ECLIPSE study.

In addition to the six-min walk distance (6 MWD), other six-min walk test (6 MWT) derived variables, such as mean walk-speed (6MWSpeed), 6-min walk-work (6 MWW), distance-saturation product (DSP), exercise-induced oxygen desaturation (EID), and unintended stops may be useful for the prediction of mortality and hospitalization in patients with chronic obstructive pulmonary disease (COPD). We studied the association between 6 MWT-derived variables and mortality as well as hospitalization in COPD patients and compared it with the BODE index. A three-year prospective study (ECLIPSE) to evaluate the prognostic value of 6 MWT-derived variables in 2010 COPD patients. Cox's proportional-hazard regressions were performed to estimate 3-year mortality and hospitalization. During the follow-up, 193 subjects died and 622 were hospitalized. An adjusted Cox's regression model of hazard ratio [HR] for impaired 6 MWT-derived variables was significant referring to: mortality (6 MWD ≤334 m [2.30], 6MWSpeed ≤0.9 m/sec [2.15], 6 MWW ≤20000 m kg [2.17], DSP ≤290 m% [2.70], EID ≤88% [1.75], unintended stops [1.99]; and hospitalization (6 MWW ≤27000 m kg [1.23], EID ≤88% [1.25], BODE index ≥3 points [1.40]; all p ≤ 0.05). The 6 MWT-derived variables have an additional predictive value of mortality in patients with COPD. The 6 MWW, EID and the BODE index refine the prognosis of hospitalization.
Predictors of intensive end-of-life and hospice care in Latino and white advanced cancer patients.

The role of end-of-life (EOL) care preferences and conversations in receipt of care near death for Latinos is unclear.



This study examines rates and predictors of intensive EOL and hospice care among Latino and white advanced cancer patients.



Two-hundred-and-ninety-two self-reported Latino (n=58) and white (n=234) Stage IV cancer patients participated in a U.S. multisite, prospective, cohort study from September 2002 to August 2008. The Latino and white, non-Hispanic participants were interviewed and followed until death, a median of 118.5 days from baseline.



Patient-reported, baseline predictors of EOL care included EOL care preference; terminal illness acknowledgement; EOL discussion; completion of a DNR order; and religious coping. Caregiver postmortem interviews provided information regarding EOL care received. Intensive EOL care was defined as resuscitation and/or ventilation followed by death in an intensive care unit. Hospice was either in- or outpatient.



Latino and white patients received intensive EOL and hospice care at similar rates (5.2% and 3.4% for intensive care, p=0.88; 70.7% versus 73.4% for hospice, p=0.33). No white or Latino patient who reported a DNR order or EOL discussion at baseline received intensive EOL care. Religious coping and a preference for life-extending care predicted intensive EOL care for white patients (adjusted odds ratio [aOR] 6.69 [p=0.02] and aOR 6.63 [p=0.01], respectively), but not for Latinos. No predictors were associated with Latino hospice care.



EOL discussions and DNR orders may prevent intensive EOL care among Latino cancer patients. Efforts should continue to engage Latino patients and caregivers in these activities.
Low power radiofrequency electromagnetic radiation for the treatment of pain due to osteoarthritis of the knee.

To investigate the analgesic effect of low power radiofrequency electromagnetic radiation (RF) in osteoarthritis (OA) of the knee.



In a randomized study on 40 patients the analgesic effect of RF was compared with the effect of transcutaneous electrical nerve stimulation (TENS). RF and TENS applications were repeated every day for a period of 5 days. The therapeutic effect was evaluated by a visual analogue scale (VAS) and by Lequesne's index: tests were performed before, immediately after and 30 days after therapy.



RF therapy induced a statistically significant and long lasting decrease of VAS and of Lequesne's index; TENS induced a decrease of VAS and of Lequesne's index which was not statistically significant.



A therapeutic effect of RF was therefore demonstrated on pain and disability due to knee OA. This effect was better than the effect of TENS, which is a largely used analgesic technique. Such a difference of the therapeutic effect may be due to the fact that TENS acts only on superficial tissues and nerve terminals, while RF acts increasing superficial and deep tissue temperature.
Evaluation of acupuncture in the management of chemotherapy-induced peripheral neuropathy.

To clinically evaluate the effectiveness of acupuncture when used in the management of chemotherapy-induced peripheral neuropathy (PN).



During cancer treatment, certain chemotherapies can cause varying degrees of PN. Patients' quality of life can be seriously impaired through loss of sensation, pain or mobility problems. Conventional medications routinely used to manage neuropathic symptoms have poor side-effect profiles and there is little or no evidence justifying their use to treat chemotherapy-related neurotoxicities. There are studies suggesting that acupuncture may be an effective therapy in treating PN across a number of different aetiologies.  A retrospective service evaluation.



Patients (n=18) were referred for acupuncture by the medical staff and/ornurse specialists or they self-referred for treatment. A course of six weekly acupuncture sessions was offered to them, and their details were recorded on an evaluation form prior to session one. Points were selected by acupuncturists, based on patient presentation, and needles remained in situ for 30-45 min. Treatments took place in outpatient clinics, chemotherapy day case ward or a drop-in clinic based in a physiotherapy gym. The evaluation form was completed at the end of session 6 by a therapist who had not been involved in patient care.



82% (n=14) of patients reported an improvement in symptoms following their course of acupuncture; one patient with advanced disease died during the 6 weeks. Some patients derived additional benefits from the treatment including a reduction in analgesic use and improved sleeping patterns. The most common acupoints used were SP6 (n=18), ST36 (n=18) and LV3 (n=14).



Although these results are encouraging, they are uncontrolled. They suggest that acupuncture could be an option for these patients and controlled trials using validated patient-reported outcome measures are justified.
Tailoring communication in consultations with women from high risk breast cancer families

This multicentre study examined the influence of patient demographic, disease status and psychological variables on clinical geneticists/genetic counsellors (consultants) behaviours in initial consultations with women from high-risk breast cancer families. One hundred and fifty-eight women completed a pre-clinic self-report questionnaire. The consultations were audiotaped, transcribed verbatim and coded. Consultants did not vary their behaviour according to women's expectations. However, significantly more aspects of genetic testing were discussed with women who were affected with breast cancer (P<0.001), screening and management with unaffected women (P=0.01) and breast cancer prevention with younger women (P=0.01). Prophylactic mastectomy was discussed more frequently with women with medical and allied health training (P=0.02), and prophylactic oophorectomy with women affected with breast cancer (P=0.03), those in non-professional occupations (P=0.04) and with a family history of breast and ovarian cancer (P<0.001). Consultants used significantly more behaviours to facilitate understanding with women who were in non-professional occupations (P=0.04); facilitated active patient involvement more with women affected with breast cancer (P<0.001) and used more supportive and counselling behaviours with affected women (P=0.02). This study showed that patient demographics were more likely to predict consultants' communication behaviours than the woman's psychological status. Methods to facilitate assessment of psychological morbidity are needed to allow more tailored communication.
Vitamin D supplementation and strontium ranelate absorption in postmenopausal women with low bone mass.

Strontium ranelate is used to treat osteoporosis. Calcium (Ca) and strontium (Sr) have common chemical features and are absorbed by the same pathways. Vitamin D has a main role in calcium intestinal absorption. The aim of this study was to investigate whether vitamin D status is a determinant of strontium ranelate absorption.



Twenty-five patients with vitamin D deficiency (25(OH)D<50 nmol/l) and 25 with vitamin D sufficiency (25(OH)D>75 nmol/l) underwent a 4-h oral Sr overload test. Sr absorption was evaluated as the fraction of absorbed dose and the area under the curve. After the baseline overload test, the deficient patients were treated until reaching sufficient vitamin D levels (25(OH)D>75 nmol/l) and the test was repeated.



Changing vitamin D status from deficient to sufficient resulted in a significant increase in 1,25(OH)2D (24.97±4.64×34.62±9.14 pg/ml, P<0.001) and a reduction in parathyroid hormone (73.87±37.50×58.24±20.13 pg/ml, P=0.006). Nevertheless, no differences were found in the parameters used to evaluate Sr absorption between the vitamin D deficient and sufficient groups. In addition, vitamin D3 replacement in the deficient group did not result in enhanced Sr absorption.



Vitamin D status did not interfere with strontium ranelate absorption. Taking into account the benefits of adequate vitamin D status in osteoporotic patients, we strongly recommend the treatment of vitamin D deficiency. However, the data demonstrate that such treatment does not enhance strontium ranelate absorption in patients with mild deficiency.
Captopril Administered at Night Restores the Diurnal Blood Pessure Rhythm in Adequately Controlled, Nondipping Hypertensives

The aim of our study was to evaluate whether captopril administered at night, can shift the circadian blood pressure (BP) from a nondipper to a dipper pattern in adequately controlled hypertensive patients, who continued their antihypertensive therapy. In a prospective, randomized, double blind, placebo-controlled designed study, we enrolled 121 treated, adequately controlled nondipping hypertensive patients. All patients were randomly assigned to 12.5 mg captopril or placebo treatment administered at night. In case of nondippers, the dosage of captopril or placebo was doubled after two weeks of treatment, while for dippers antihypertensive regimens were not changed. After another two weeks, all patients underwent ambulatory BP monitoring. Our results show that at the end of the active treatment period, the prevalence of a dipping diurnal BP pattern in the captopril group (70%) was significantly higher than that in the placebo group (9.8%, P < 0.001). Nighttime BP, night/day BP ratio, nighttime BP load and 24-h systolic BP were significantly lower after 4 weeks nighttime captopril treatment compared to baseline. In conclusion, the present study demonstrates for the first time that captopril administered at night can restore the diurnal BP rhythm and decrease the elevated night/day BP ratio in appropriately controlled, nondipper hypertensive patients. These results were mainly due to the decrease of nighttime BP.
“One Teabag Is Better than Four”: Participants Response to the Discontinuation of 2% PRO2000/5 Microbicide Gel in KwaZulu-Natal, South Africa

The Microbicides Development Programme evaluated the safety and effectiveness of 0.5% and 2% PRO2000/5 microbicide gels in reducing the risk of vaginally acquired HIV. In February 2008 the Independent Data Monitoring Committee recommended that evaluation of 2% PRO2000/5 gel be discontinued due to futility. The Africa Centre site systematically collected participant responses to this discontinuation.



Clinic and field staff completed field reports using ethnographic participant observation techniques. In-depth-interviews and focus group discussions were conducted with participants discontinued from 2% gel. A total of 72 field reports, 12 in-depth-interviews and 3 focus groups with 250 women were completed for this analysis. Retention of discontinued participants was also analysed. Qualitative data was analysed using NVivo 2 and quantitative data using STATA 10.0.



Participants responded initially with fear that discontinuation was due to harm, followed by acceptance after effective messaging, and finally with disappointment. Participants reported that their initial fear was exacerbated by being contacted and advised to visit the clinic for information about the closure. Operational changes were subsequently made to the contact procedures. By incorporating feedback from participants, messages were continuously revised to ensure that information was comprehensible and misconceptions were addressed quickly thereby enabling participants to accept the discontinuation. Participants were disappointed that 2% PRO2000/5 was being excluded as a HIV prevention option, but also that they would no longer have access to gel that improved their sexual relationships with their partners and assisted condom negotiations. In total 238 women were discontinued from gel and 185 (78%) went on to complete their scheduled follow-up period.



The use of qualitative social science techniques allowed the site team to amend operational procedures and messaging throughout the discontinuation period. This proved instrumental in ensuring that the discontinuation was successfully completed in a manner that was both understandable and acceptable to participants.
Lower striatal dopamine transporter binding in neuroleptic-naive schizophrenic patients is not related to antipsychotic treatment but it suggests an illness trait

Drug induced parkinsonism (DIP) is directly related to dopamine D2 receptor blockade. However, there are many references describing parkinsonian signs (PS) in naive-patients. In our previous study, we observed lower DAT binding in a group of first-episode schizophrenic patients after short-term treatment with risperidone, compared with age-matched healthy controls. To clarify if DAT decrease could be an illness trait, excluding the effect of antipsychotics on DAT availability, and to determine whether DAT availability before treatment with antipsychotics may predict subsequent development of PS. A new series of 20 neuroleptic-naive schizophrenic patients and 15 healthy subjects was recruited. SPECT with [123I] FP-CIT (DaTSCAN®) was performed before starting antipsychotics and after 4 weeks of treatment. PS and psychopathological status were assessed by the Simpson–Angus (SAS), CGI and PANSS scales. Quantitative analyses of SPECTs were performed using ROIs placed in the caudate, putamen and occipital cortex. Schizophrenic patients showed lower DAT binding compared with the healthy subjects at baseline (p<0.001) and after a 4-week-treatment period (p=0.001). Six out of eight schizophrenic patients of the DIP group were symptomatic for PS at baseline, in comparison to two out of 12 in the NoDIP group. Nonetheless, no differences were observed on DAT between DIP and NoDIP, neither at baseline (p=0.360) nor at endpoint (p=0.984). Finally, no differences between baseline–endpoint DAT binding were observed, neither in the DIP group (p=0.767) nor in the NoDIP group (p=0.093). Our new series of first-episode naive-schizophrenic patients (1) points out DAT dysfunction as an illness trait due to the significantly lower DAT binding in schizophrenic patients in comparison to healthy subjects; (2) supports the results of other authors who describe PS in never-treated patients; (3) confirms that [123I] FP-CIT does not allow us to predict which patients will develop parkinsonism due to the lack of differences between DIP and NoDIP patients; and (4) confirms a null effect of antipsychotics on DAT due to the lack of differences in [123I] FP-CIT before and after a 4-week-treatment period.
Nasolacrimal duct obstruction as a complication of iodine-131 therapy in patients with thyroid cancer.

There are few studies evaluating the effect of radioioine therapy on the lacrimal drainage system. This study reports on symptomatic and asymptomatic nasolacrimal duct obstruction (NLDO) as complications of high-dose radioiodine therapy in these patients.



Eighty-one cases were randomly selected from a population of radioiodine-treated differentiated thyroid carcinoma patients and were enrolled in a historical cohort study. The patients were categorized into four subgroups on the basis of the received cumulative dose of iodine-131 (I-131). In addition, 17 age-matched and sex-matched individuals were selected as the control group. Using dacryoscintigraphy and a clinical datasheet, the patients and controls were evaluated for partial or complete and symptomatic or asymptomatic NLDO. The data on different subgroups of patients were compared with the data of the control group.



Twenty-nine out of 162 exposed eyes (18%) and three out of 34 control eyes (9%) had evidence of NLDO on scintigraphic images. Among patients treated with less than 11.1 GBq of I-131 (subgroup A), six out of 78 eyes (7.7%) had partial or complete NLDO. This was evident in 23 out of 84 eyes (27.4%) among patients treated with 11.1 GBq or more (subgroup B). The frequency of complete NLDO increases significantly when the cumulative dose of radioiodine exceeds 11.1 GBq (2.9% in the control group, 3.8% in subgroup A, and 23.8% in subgroup B; P=0.006).



NLDO may be considered as a side effect of I-131 therapy, especially with a cumulative dose of 11.1 GBq or more.
A pilot, multisite, randomized controlled trial of a self-directed coping skills training intervention for couples facing prostate cancer: accrual, retention, and data collection issues

To examine the acceptability of the methods used to evaluate Coping-Together, one of the first self-directed coping skill intervention for couples facing cancer, and to collect preliminary efficacy data. Forty-two couples, randomized to a minimal ethical care (MEC) condition or to Coping-Together, completed a survey at baseline and 2 months after, a cost diary, and a process evaluation phone interview. One hundred seventy patients were referred to the study. However, 57 couples did not meet all eligibility criteria, and 51 refused study participation. On average, two to three couples were randomized per month, and on average it took 26 days to enrol a couple in the study. Two couples withdrew from MEC, none from Coping-Together. Only 44 % of the cost diaries were completed, and 55 % of patients and 60 % of partners found the surveys too long, and this despite the follow-up survey being five pages shorter than the baseline one. Trends in favor of Coping-Together were noted for both patients and their partners. This study identified the challenges of conducting dyadic research, and a number of suggestions were put forward for future studies, including to question whether distress screening was necessary and what kind of control group might be more appropriate in future studies.