nils-herrmann/clean_scirepeval huggingface dataset:
Randomized clinical trial of imiquimod: an adjunct to treating cervical dysplasia.

Human papillomavirus (HPV) infection is a major risk factor for cervical cancer. Imiquimod is a topical medication that enhances the immune response to HPV-induced genital warts. This study evaluated cervical application of imiquimod as an adjunct to standard treatment for cervical dysplasia.



Fifty-six patients were randomized to standard excisional/ablative treatment vs applications of imiquimod followed by standard treatment. The primary endpoint was dysplasia recurrence within 2 years.



There were no differences in dysplasia recurrence between the 2 groups. Treatment was well tolerated, with side effects being mild but significantly worse in women receiving imiquimod for, chills, fatigue, fever, headache, myalgias, and vaginal discharge.



This trial does not support the hypothesis that imiquimod, as used in this trial, has an impact on recurrence of cervical dysplasia, but the adequacy of findings are limited by sample size. The trial does support the feasibility and acceptability of the use of imiquimod on the cervix.
Radiological and biochemical effects (CTX-II, MMP-3, 8, and 13) of low-level laser therapy (LLLT) in chronic osteoarthritis in Al-Kharj, Saudi Arabia

Inflammation of synovial membrane and degeneration of articular cartilage in osteoarthritis (OA) lead to major changes in joint space width (JSW) and biochemical components such as collagen-II telopeptide (CTX-II) and matrix metallo protineases (MMP-3, 8, and 13). Low-level laser therapy (LLLT) is thought to have an analgesic effect as well as biomodulatory effect on microcirculation and cartilage regeneration in animal studies. The objective of this study was to examine the analgesic and biochemical effect of LLLT in patients with knee osteoarthritis. Subjects (n = 34) who fulfilled the selection criteria were randomly divided into active group (n = 17) and placebo group. Subjects in active group were irradiated laser with the frequency of 3 days per week for 4 weeks with the specific parameters on 8 different points on the joint at 1.5 J per point for 60 s for 8 points for a total dose of 12 J in a skin contact method. The placebo group was treated with the same probe with minimum emission of energy. Visual analog scale for pain intensity, joint space width, collagen-II telopeptide, and matrix metallo protinease-3, 8, and 13 was measured before treatment and at 4 and 8 weeks following treatment. Data are analyzed with mean values and standard deviation with p < 0.05. Baseline values of all outcome measures show insignificant difference (p > 0.05) in both groups which shows homogeneity. After 4- and 8-week treatment, active laser group shows more significant difference (p < 0.001) in all the parameters than the placebo laser group (p > 0.05). Our results show that low-level laser therapy was more efficient in reducing pain and improving cartilage thickness through biochemical changes.
Colonic transit in the empty colon after defunctioning ileostomy: Do we really know what happens?

There is disagreement amongst surgeons about the use of oral mechanical bowel preparation (MBP) prior to low anterior resection with diverting ileostomy. Colonic transit in the early post-operative period is an important factor in determining the role of MBP, as propagation of any stool remaining in the defunctioned colon may exacerbate morbidity in the event of anastomotic leak. We studied colonic transit time in the first 7 days following low anterior resection with diverting ileostomy. We conducted a prospective observational study of patients with rectal cancer undergoing elective low anterior resection with diverting ileostomy in a tertiary colorectal unit. Twenty radio-opaque markers were inserted into the caecum via the distal limb of the loop ileostomy at surgery. Plain abdominal radiographs were taken on post-operative days 1, 3 and 5. The primary endpoint was passage of the markers to the neorectum. Data were collected on treatment, return of gastrointestinal function and complications. Twenty-two patients (mean age 68.5 years; 18 males) participated in the study. In 20 patients, all markers remained in the right colon on day 7. Three markers were present in the left colon in one patient, and eight markers were present in the neorectum in another patient, on the seventh day. Colonic transit may be abolished by the presence of diverting ileostomy. It should now be established whether clearance of the left colon alone, using enemas, is sufficient for patients undergoing low anterior resection, thus avoiding the morbidity associated with oral MBP.
Concerns of family members of patients receiving palliative sedation therapy

Symptomatic sedation is often required in terminally ill cancer patients and could cause significant distress to their families. The aim of this study was to gather vivid family descriptions about their experiences in palliative sedation therapy. This report is an additional analysis of a multicenter questionnaire survey. We performed content analysis on 48 statements described by 185 bereaved family members of patients who received palliative sedation therapy. Family members reported guilt, helplessness, and physical and emotional exhaustion when patients received palliative sedation therapy. They were concerned about whether sedated patients experienced distress, wished to know that the maximum efforts had been made, wished to prepare for patient death, wished to tell important things to patients before sedation, wished to understand patients’ suffering, and wanted medical professionals to treat patients with dignity. To alleviate family distress, clinicians should understand families’ emotional distress, ensure that unconscious patients feel no distress, reassure family members that the symptoms are truly refractory despite maximum efforts for symptom relief, give information and coordinate the situation to enable families to prepare for patient death and to tell important things to patients before sedation, help families to share patients’ suffering, and treat patients the same as when they remained conscious.
Hip abductor control in walking following stroke -- the immediate effect of canes, taping and TheraTogs on gait.

To confirm previous findings that hip abductor activity measured by electromyography (EMG) on the side contralateral to cane use is reduced during walking in stroke patients. To assess whether an orthosis (TheraTogs) or hip abductor taping increase hemiplegic hip abductor activity compared with activity during cane walking or while walking without aids. To investigate the effect of each condition on temporo-spatial gait parameters.



Randomized, within-participant experimental study.



Gait laboratory.



Thirteen patients following first unilateral stroke.



Data collection over six gait cycles as subjects walked at self-selected speed during: baseline (without aids) and in randomized order with (1) hip abductor taping, (2) TheraTogs, (3) cane in non-hemiplegic hand.



Peak EMG of gluteus medius and tensor fascia lata and temporo-spatial gait parameters.



Cane use reduced EMG activity in gluteus medius from baseline by 21.86%. TheraTogs increased it by 16.47% (change cane use-TheraTogs P = 0.001, effect size = -0.5) and tape by 5.8% (change cane use-tape P = 0.001, effect size = -0.46). In tensor fascia lata cane use reduced EMG activity from baseline by 19.14%. TheraTogs also reduced EMG activity from baseline by 1.10% (change cane use-TheraTogs P = 0.009, effect size -0.37) and tape by 3% (not significant). Gait speed (m/s) at: baseline 0.44, cane use 0.45, tape 0.48, TheraTogs 0.49.



Hip abductor taping and TheraTogs increase hemiplegic hip abductor activity and gait speed during walking compared with baseline and cane use.
The influence of biofeedback training on trapezius activity and rest during occupational computer work: a randomized controlled trial

The aim of this study was to investigate effects of biofeedback training on trapezius activity and rest (gaps) during occupational computer work. A randomized controlled trial with 164 computer workers was performed. Two groups working with computer mouse more than 50% (n = 64) and less than 25% (n = 49) of their work time performed five sessions with unilateral electromyographical (EMG) biofeedback from the dominant trapezius during computer work. A third group working with computer mouse more than 50% of their work time (n = 51) served as controls. Bipolar EMG from the bilateral upper trapezius muscles during normal computer work was recorded. Changes in discomfort/pain were not recorded. The biofeedback training reduced activity (P < 0.05), and increased the frequency of short (P < 0.05) and long (P < 0.05) gaps, and the relative rest time (P < 0.05) of the trapezius during computer work. By improving trapezius inactivity during computer work, biofeedback training may have the potential to prevent trapezius myalgia in computer workers.
Combination vinorelbine and capecitabine for metastatic breast cancer using a non-body surface area dosing scheme

This study sought to determine the maximum tolerated dose of flat-dosed vinorelbine in combination with capecitabine in patients with metastatic breast cancer. At the time of study initiation, it was anticipated that vinorelbine would be developed as an oral capsule. A flat dosing scheme of both drugs was used to facilitate development of the oral regimen, and because neither drug’s clearance is associated with body surface area (BSA), pharmacokinetic and pharmacogenetic endpoints were explored.  Capecitabine was administered orally at 3,000 mg/day on days 1–14. The starting dose of vinorelbine was 20 mg intravenously on days 1 and 8 of a 21-day cycle. The vinorelbine dose was escalated until dose limiting toxicity (DLT). Vinorelbine pharmacokinetics were measured after the first dose. Patients underwent genotype analysis for polymorphisms in the CYP3A5 gene, and the erythromycin breath test (ERMBT), a phenotypic test of CYP3A enzyme activity.  Twenty five eligible patients were enrolled. Hematologic DLT was seen at the 50 and 45 mg vinorelbine doses; thus the recommended dose is 40 mg on days 1 and 8. Response rate was 30%, and disease stabilization rate was 64% (all dose levels included). Vinorelbine clearance was not associated with ERMBT, BSA, or age. CYP3A5 genotype in this small sample did not have an obvious relationship to clearance or toxicity.  A non-BSA based dosing scheme of capecitabine and vinorelbine is safe and efficacious. BSA did not affect vinorelbine clearance. We recommend future studies with capecitabine and/or vinorelbine to compare the safety and efficacy of flat dosed versus BSA-dosed treatment.
The sRNA SorY confers resistance during photooxidative stress by affecting a metabolite transporter in Rhodobacter sphaeroides

Exposure to oxygen and light generates photooxidative stress by the bacteriochlorophyll a mediated formation of singlet oxygen ((1)O2) in the facultative photosynthetic bacterium Rhodobacter sphaeroides. We have identified SorY as an sRNA, which is induced under several stress conditions and confers increased resistance against (1)O2. SorY by direct interaction affects the takP mRNA, encoding a TRAP-T transporter. We present a model in which SorY reduces the metabolite flux into the tricarboxylic acid cycle (TCA cycle) by reducing malate import through TakP. It was previously shown that oxidative stress in bacteria leads to switch from glycolysis to the pentose phosphate pathway and to reduced activity of the TCA cycle. As a consequence the production of the prooxidant NADH is reduced and production of the protective NADPH is enhanced. In R. sphaeroides enzymes for glycolysis, pentose phosphate pathway, Entner-Doudoroff pathway and gluconeogenesis are induced in response to (1)O2 by the alternative sigma factor RpoHII. The same is true for the sRNA SorY. By limiting malate import SorY thus contributes to the balance of the metabolic fluxes under photooxidative stress conditions. This assigns a so far unknown function to an sRNA in oxidative stress response.
Large-joint damage in patients with early rheumatoid arthritis and its association with treatment strategy and damage of the small joints.

To determine the prevalence of large-joint damage and the association with small-joint damage in patients with RA after 8 years of low DAS (≤2.4)-targeted treatment with different treatment strategies.



Radiological data of 290 patients participating in the BeSt study, a randomized trial comparing initial monotherapy and initial combination therapy strategies, were used. Radiographs of large joints were scored using the Larsen score and of the small joints using the Sharp-van der Heijde score. With multivariate logistic regression analysis, an association between total damage of the small joints and of the large joints was investigated.



After 8 years of treatment, damage was observed in 12% of shoulders, 10% of elbows, 26% of wrists, 13% of hips, 18% of knees and 7% of the ankles. Damage in one or more large joints was found in 64% of patients, with a median score of 1. No difference was found between initial monotherapy or combination therapy strategies. There was a significant association between damage progression in small joints and damage to one or more large joints (OR 1.02; 95% CI 1.00-1.04).



After 8 years of DAS-targeted treatment in early RA patients, large-joint damage was found in 64% of patients and was associated with small-joint damage. Continued DAS-targeted treatment is probably more important in damage suppression than initial treatment strategy. Patients with more damage to hands and feet also have more damage to the large joints.
Research Paper: A Randomized Trial Comparing Telemedicine Case Management with Usual Care in Older, Ethnically Diverse, Medically Underserved Patients with Diabetes Mellitus

Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions who experience barriers to access to care or a high burden of illness.



The authors conducted a randomized, controlled trial comparing telemedicine case management to usual care, with blinding of those obtaining outcome data, in 1,665 Medicare recipients with diabetes, aged 55 years or greater, and living in federally designated medically underserved areas of New York State. The primary endpoints were HgbA1c, blood pressure, and low-density lipoprotein (LDL) cholesterol levels.



In the intervention group (n = 844), mean HgbA1c improved over one year from 7.35% to 6.97% and from 8.35% to 7.42% in the subgroup with baseline HgbA1c > or =7% (n = 353). In the usual care group (n = 821) mean HgbA1c improved over one year from 7.42% to 7.17%. Adjusted net reductions (one-year minus baseline mean values in each group, compared between groups) favoring the intervention were as follows: HgbA1c, 0.18% (p = 0.006), systolic and diastolic blood pressure, 3.4 (p = 0.001) and 1.9 mm Hg (p < 0.001), and LDL cholesterol, 9.5 mg/dL (p < 0.001). In the subgroup with baseline HgbA1c > or =7%, net adjusted reduction in HgbA1c favoring the intervention group was 0.32% (p = 0.002). Mean LDL cholesterol level in the intervention group at one year was 95.7 mg/dL. The intervention effects were similar in magnitude in the subgroups living in New York City and upstate New York.



Telemedicine case management improved glycemic control, blood pressure levels, and total and LDL cholesterol levels at one year of follow-up.
Approaches to methadone treatment: harm reduction in theory and practice.

The paper analyses methadone treatment in Copenhagen -- as it is described by methadone users and staff at different outpatient centres. The starting point is a theoretical model distinguishing between two different approaches to methadone treatment: 'palliative' and 'curative'. Included in the model are three dimensions (1) treatment goals at the methadone centres (abstinence vs. stabilisation) (2) treatment focus (focus on addiction vs. focus on the consequences of addiction) and (3) conceptualisation of methadone (methadone as similar to or different from heroin). The paper shows that there is a discrepancy between the attitudes of the staff and those of the users. While the staff favour an almost clear-cut palliative approach to methadone treatment, defining curative goals as both unrealistic and as belonging to the past, the users prefer an approach that does not exclude the goal of abstinence and does not focus on the consequences of drug use alone but also on their problematic relationship to drugs (legal as well as illegal). Furthermore, the users' attitudes towards methadone are far more ambivalent than the staff's. For the users, methadone is not just medicine; it is also a dependence-producing and 'dangerous' drug.
Prehospital cardiac arrest and the adverse effect of male gender, but not age, on outcome.

To analyze the incidence and outcome of prehospital cardiac arrest as it correlated to gender and age as a secondary end point in an interventional clinical trial.



This prospective, randomized, double-blinded clinical intervention trial enrolled 874 prehospital cardiopulmonary arrest patients encountered by prehospital urban, suburban, and rural regional emergency medical service (EMS) areas. This trial evaluated outcome and profiled demographic predictors of cardiac arrest patients refractory to defibrillation with intravenous access who underwent standard advanced cardiac life support (ACLS) intervention and empiric early administration of bicarbonate. Survival was measured to the emergency department (ED), and data analysis used chi-square with Pearson correlation.



The overall survival rate was 14.2%. There was no age correlate to survival, with an average age of 67.4 for both groups. Male patients had a 2.4-fold increased incidence (70.7 vs. 29.3%, p = 0.001) of arrest, which was associated with a 60% increase in mortality (19.6% vs. 11.8, p = 0.004) compared with women. The risk of unfavorable outcome was increased for men (OR 1.826, 95% CI 1.182-2.821; RR 1.097, 95% CI 1.025-1.180) on univariate analysis. There appeared to be no intergroup differences found with other historical variables, such as the presence of myocardial infarction (MI), hypertension (HTN), diabetes mellitus (DM), congestive heart failure (CHF), and chronic obstructive pulmonary disease (COPD), which were analyzed. However, HTN was found more commonly (2.2 times) in men (69.1 vs. 30.9%) than in women but did not correlate with survival.



Male gender, but not age, is associated with both an increased incidence and a worsened outcome in prehospital cardiac arrest.
[Comparison of the effectiveness and safety of polyethylene glycol with and without electrolytes in the treatment of chronic constipation].

To compare the effectiveness and safety of polyethylene glycol with and without electrolytes (EL) over a 12 week period in treatment of chronic constipation in paediatrics.



This was an observational, prospective, longitudinal, parallel group study, including 62 children with chronic constipation according to ROME III criteria and a history of faecal impaction. The children were divided into groups, one group of 30 received polyethylene glycol without EL (PEG) and 32 PEG with EL (PEG+EL) for at least 12 weeks. The main outcomes were the number of bowel movements at 6 and 12 weeks, and the presence of electrolyte disturbances at 6 weeks.



The mean weekly stool frequencies were similar in both groups at 6 and 12 weeks, with 5.4 and 4.6 stools per week in the PEG+EL and PEG groups, respectively at 12 weeks. After 6 weeks of treatment, 83% (25 of 30) of the PEG group had at least one electrolyte disturbance compared with 56% (18 of 32) in the PEG+EL group (P=.02). Hyponatraemia was found in 15% (5 of 32) vs. 36% (11 of 30) of PEG+EL and PEG groups, respectively (P=.05). None of the laboratory abnormalities were clinically relevant.



PEG formulations with or without EL have a quite similar effectiveness, safety and acceptability. PEG without EL produced more electrolyte abnormalities, but none of them were symptomatic.
A phase 2 trial of once-weekly hypofractionated breast irradiation: first report of acute toxicity, feasibility, and patient satisfaction.

To report on early results of a single-institution phase 2 trial of a 5-fraction, once-weekly radiation therapy regimen for patients undergoing breast-conserving surgery (BCS).



Patients who underwent BCS for American Joint Committee on Cancer stage 0, I, or II breast cancer with negative surgical margins were eligible to receive whole breast radiation therapy to a dose of 30 Gy in 5 weekly fractions of 6 Gy with or without an additional boost. Elective nodal irradiation was not permitted. There were no restrictions on breast size or the use of cytotoxic chemotherapy for otherwise eligible patients. Patients were assessed at baseline, treatment completion, and at first posttreatment follow-up to assess acute toxicity (Common Terminology Criteria for Adverse Events, version 3.0) and quality of life (European Organization for Research and Treatment of Cancer QLQ-BR23).



Between January and September 2011, 42 eligible patients underwent weekly hypofractionated breast irradiation immediately following BCS (69.0%) or at the conclusion of cytotoxic chemotherapy (31.0%). The rates of grade ≥2 radiation-induced dermatitis, pain, fatigue, and breast edema were 19.0%, 11.9%, 9.5%, and 2.4%, respectively. Only 1 grade 3 toxicity-pain requiring a course of narcotic analgesics-was observed. One patient developed a superficial cellulitis (grade 2), which resolved with the use of oral antibiotics. Patient-reported moderate-to-major breast symptoms (pain, swelling, and skin problems), all decreased from baseline through 1 month, whereas breast sensitivity remained stable over the study period.



The tolerance of weekly hypofractionated breast irradiation compares well with recent reports of daily hypofractionated whole-breast irradiation schedules. The regimen appears feasible and cost-effective. Additional follow-up with continued accrual is needed to assess late toxicity, cosmesis, and disease-specific outcomes.