nils-herrmann/clean_scirepeval huggingface dataset:
Effectiveness of a nurse facilitated cognitive group intervention among mild to moderately-depressed-women in KwaZulu-Natal, South Africa.

The purpose of the study was to determine the effectiveness of a nurse-facilitated-cognitive-group (NFCG) intervention as an adjunct to antidepressant medication, in mild to moderately, depressed women.



This was a quasi-experimental, nonequivalent, control group design study. A sample of 30 consenting participants was selected from an urban, community psychiatric clinic, and the participants were randomly allocated to the control and the intervention groups. The effectiveness of the intervention was measured using the Beck Depression Inventory (BDI).



After six weeks of implementation of the NFCG intervention, there was a decrease in the BDI scores of the intervention group, and an increase in the BDI scores in the control group (CG) - but the difference in scores was not significant (Student's t-test=1.076, p=0.291). After 12 weeks of the group intervention, the BDI scores for the intervention group, showed a considerable reduction in their levels of depression, whilst the participants of the control group had a further increase in their scores. There was a statistically significant difference between the groups, with respect to the BDI scores (p<0.001). The Friedman test indicated that the mean BDI scores, were statistically significant (p<0.001) within the intervention group, meaning that the BDI scores improved, at the end of the intervention for all the participants. Analysis of the BDI scores, using the Friedman test, showed that there was no improvement in the control group (p=0.597).



The NFCG intervention, as an adjunct to antidepressant medication, contributed to a reduction in depressive symptoms.
Autologous hematopoietic stem cell transplantation in refractory rheumatoid arthritis: sustained response in two of four patients.

To investigate the safety and efficacy of immune ablation with subsequent autologous hematopoietic stem cell transplantation (HSCT) in severe rheumatoid arthritis (RA).



Four patients with refractory RA and poor prognostic indicators were treated. Stem cells were collected and lymphocytes were depleted by 2.3-4.0 logs. The conditioning regimen included cyclophosphamide (200 mg/kg), antithymocyte globulin (90 mg/kg), and, for 1 patient, total body irradiation (TBI) with 400 cGy. Improvement was evaluated according to the American College of Rheumatology (ACR) preliminary definition of improvement in RA (ACR 20), and also according to the ACR 50 and ACR 70 criteria.



HSCT was well tolerated. Three patients fulfilled the ACR 70 criteria at 1 month and 3 months post-HSCT. One patient did not fulfill the ACR 20 criteria because of persistent joint tenderness, despite improvement of the joint swelling. At 6 months post-HSCT, 1 patient fulfilled the ACR 70 criteria and 1 fulfilled the ACR 50 criteria, and these 2 patients fulfilled the ACR 70 criteria at 9 months post-HSCT. The other 2 patients (including the patient who received TBI) did not meet the ACR 20 criteria at 6 months and 9 months post-HSCT. The only patient with followup of >9 months fulfilled the ACR 70 criteria at 20 months post-HSCT.



In this series, autologous HSCT was safe and effective in inducing major clinical response and maintained significant benefit for 2 patients at 9 months and 20 months posttreatment, respectively. Sustained response did not occur for 2 of 4 patients. A regimen dose-response effect may exist, but the addition of TBI did not prevent disease relapse for 1 of the patients. More aggressive T cell depletion of the autograft, use of a myeloablative regimen, or use of an allograft may be necessary to decrease relapse rates.
Parental stress in mothers of children and adolescents with cerebral
palsy

to evaluate parental stress of mothers of children and adolescents with cerebral palsy; to verify whether parental stress undergoes variations according to the level of motor compromise, the child's phase of life, and sociodemographic variables.



a cross-sectional, descriptive study, with 223 mothers of children and adolescents with cerebral palsy.



45.3% of the mothers presented high levels of stress; there were differences in stress between mothers of children with mild and severe motor impairment; mothers of older children were more stressed than mothers of younger children and of adolescents; paid work and leisure activities reduced the stress.



mothers of children and adolescents with cerebral palsy, whose children present mild to severe motor impairment are vulnerable to parental stress. Paid work and leisure activities were the factors that contributed most to reducing the stress.
Natural history and risk factors for adjacent vertebral fractures in the fracture intervention trial.

Retrospective analysis of prospectively collected follow-up data for 2.9 years.



To determine the natural history of subsequent morphometric fracture rates at adjacent levels (one level above or below a previous known baseline fracture) in a large patient database.



The long-term risk and risk factors for adjacent-level vertebral fractures in patients with osteoporosis are unknown.



The fracture intervention trial is a large randomized, placebo-controlled trial of alendronate treatment for osteoporosis. Data from both bisphosphonate-treated and bisphosphonate-naive patients (N = 1950, vertebral fracture arm) was analyzed to detect incident morphometric fracture rates.



During a mean follow-up of 2.9 years, 3.4% of patients in the alendronate group and 7.4% in the placebo group experienced adjacent-level vertebral fractures. The annual rate of adjacent-level vertebral fractures was 1.2% in the alendronate group, and 2.5% in the placebo group (overall, 1.8% per year in both groups combined). As expected, the thoracolumbar region (defined as T11, T12, and L1) seemed to be the most prone to new adjacent-level fractures. Among females with baseline prevalent fractures at the thoracolumbar junction, who subsequently experienced at least one new fracture anywhere along the spine (N = 124), 40.3% had a new adjacent-level fracture in this region. Older age at randomization, lower bone mineral density, inactivity, and placebo therapy were significantly associated with the development of adjacent-level fractures in univariate analysis (P ≤ 0.05). Multivariate analysis indicated decreased odds of adjacent-level fractures with bisphosphonate therapy and higher bone mineral density, and increased odds with older age at randomization (P ≤ 0.05).



New vertebral fractures adjacent to prevalent fractures occurred relatively infrequently in this treatment trial of alendronate in females with osteoporosis, and were more common with older age at randomization, lower bone mineral density and placebo treatment.
Comparison of total body irradiation vs busulfan in combination with cyclophosphamide as conditioning for unrelated stem cell transplantation in CML patients

We compared fractionated total body irradiation (12 Gy)/cyclophosphamide (120 mg/kg) with busulfan (16 mg/kg)/cyclophosphamide (120 mg/kg) as preparative therapy in unrelated donor stem cell transplantation of CML patients. Fifty patients with CML (1.CP = 46; aP = 4) and a median age of 36 years (range 16–52) were enrolled in this sequential trial between 1994 and 1999. In both groups patients were well balanced with respect to age, disease status, stem cell source and CMV status. All patients received standard doses of cyclosporin A, methotrexate and anti-thymocyte globulin (ATG) as GVHD prophylaxis. No graft failures occurred in either group. The median day of leukocyte engraftment was earlier in the Bu/Cy than in the TBI/Cy group (day 15 vs 17; P = 0.006). The incidence of grade II–IV GVHD was 40% in the TBI/Cy and 36% in the Bu/Cy group, whereas severe grade III/IV GVHD was only observed in 12% of patients in both groups. The incidence of chronic GVHD (limited and extensive) at 1 year was higher in the Bu/Cy arm (65% vs 30%; P = 0.02). More toxicity grade I/II of the liver (88% vs 44%; P = 0.002) and more hemorrhagic cystitis (32% vs 8%; P = 0.02) were observed in the Bu/Cy regimen. Seven relapses in the TBI and no relapse in the Bu/Cy group were observed after a median follow-up of 44 and 15 months, respectively. The estimated 3 year OS and DFS was 72% (95% CI: 55–98%) and 58% (95% CI: 39–77%) in the TBI and 70% (95% CI: 51–89%) for DFS and OS in the Bu/Cy group. We conclude that the anti-leukemic effect of the Bu/Cy regimen seems to be at least as effective as the TBI/Cy combination in unrelated stem cell transplantation of CML patients, with no graft failures, but that it correlates with a higher incidence of liver toxicity, hemorrhagic cystitis and chronic GVHD. Longer follow-up is necessary to determine the late relapse rate and late toxicity. Bone Marrow Transplantation (2001) 27, 349–354.
Co-existence of insulin resistance and high concentrations of circulating oxidized LDL lipids.

Insulin metabolism has been previously linked to oxidized low-density lipoproteins (ox-LDL), but corroborating intervention studies are lacking. We investigated whether changes in ox-LDL levels are accompanied by changes in insulin sensitivity in a 32-month life-style intervention study.



A 2-month weight reduction was followed by 6-month diet and exercise counselling and a 2-year follow-up period. Men of 35-50 years of age, BMI ≥ 30 kg/m(2), and waist circumference > 100 cm were recruited via newspapers in the city of Tampere, Finland. Of the 90 men meeting the inclusion criteria, 67 (76%) completed the study. Ox-LDL was estimated as the presence of oxidized lipids in LDL. Homeostasis model assessment of insulin resistance (HOMA-IR), ox-LDL, and ratio of ox-LDL and high-density lipoprotein cholesterol (ox-LDL/HDL-c) were used as the main outcome measures.



The detected changes in HOMA-IR were strikingly similar to those in ox-LDL and ox-LDL/HDL-c. Compared to the first HOMA-IR quartile, the fourth quartile had 23%-51% higher concentrations in ox-LDL and ox-LDL/HDL-c at all time points (P < 0.05 for all).



This weight reduction intervention study adds evidence to support the connection between insulin metabolism and oxidized LDL, possibly contributing to the higher incidence of atherosclerotic cardiovascular diseases among diabetic patients.
A randomized controlled clinical trial of pacemaker follow-up in clinic and by telemedical interpretation of the pacemakers' magnet mode.

We assessed a two-stage follow-up procedure for cardiac pacemakers, where in-clinic follow-ups were partly replaced by telemedical follow-ups. This was compared with the standard follow-up regime (in-clinic follow-up only). The new procedure required an electronic patient record, a telemedical follow-up unit for recording ECGs while the pacemaker was temporarily set to magnet mode, an ECG processing unit, and a reviewing and reporting unit. A total of 177 (86 female) patients were randomized to the control group and 182 (98 female) patients to the telemedicine group. In the telemedicine group, 234 telemedical follow-ups were performed. Out of these, 68 required an additional in-clinic follow-up, while 166 were sufficient for assessing the pacemakers' working status. During the study, there were 19 deaths in the telemedicine group and 20 in the control group. There was no significant difference between the two groups(P = 0.40). The probability that an individual patient's pacemaker would not to be replaced over time was analysed in a similar way to the Kaplan-Meier survival function. Fewer pacemakers were replaced in the telemedicine group (14) than in the control group (18), but the difference was not significant (P = 0.26). We conclude that alternating telemedical and in-clinic follow-ups brings no additional risks for patients. The follow-up procedure is feasible and interpretation of the pacemakers' magnet effect provides an easy-to-use, manufacturer-independent method of assessing the pacemakers' working status. This should reduce the patient load on pacemaker centres and decrease the overall costs of pacemaker therapy.
Absence of coronary artery calcification and all-cause mortality.

We sought to quantify the mortality rates associated with absent and low positive (CAC 1 to 10) coronary artery calcium (CAC).



There is increasing interest in the absence of CAC as a "negative" cardiovascular risk factor. However, published event rates for individuals with no CAC vary, likely owing to differences in baseline risk, follow-up period, and outcome ascertainment. The prognostic significance of low CAC (CAC 1 to 10) is not well described.



Annualized all-cause mortality rates were assessed in 44,052 consecutive asymptomatic patients referred for CAC testing. Mean follow-up of the cohort was 5.6 +/- 2.6 years (range 1 to 13 years).



A total of 19,898 patients (45%) had no CAC on screening electron beam tomography, whereas 5,388 (12%) had low levels of CAC (CAC 1 to 10), and 18,766 (43%) had CAC >10. There were 104 deaths in those with no CAC (0.52%), 58 deaths in those with CAC 1 to 10 (1.06%), and 739 deaths in those with CAC >10 (3.96%). Annualized all-cause mortality rates for CAC = 0, CAC 1 to 10, and CAC >10 were 0.87, 1.92, and 7.48 deaths/1,000 person-years, respectively. The hazard ratio (HR) for all-cause mortality among CAC 1 to 10 versus CAC = 0 after adjustment for traditional risk factors was 1.99 (95% confidence interval [CI]: 1.44 to 2.75). Smoking (HR: 3.97, 95% CI: 2.75 to 5.41) and diabetes mellitus (HR: 3.36, 95% CI: 2.09 to 5.41) were associated with few events observed in CAC = 0 group.



In appropriately selected asymptomatic patients, the absence of CAC predicts excellent survival with 10-year event rates of approximately 1%. A finding of 0 CAC might be used as a rationale to emphasize lifestyle therapies rather than pharmacotherapy and to forgo repeated imaging studies. Individuals with low CAC score (CAC 1 to 10) are at increased risk above individuals with a 0 score and could be considered a distinct risk group by physicians and investigators.
Spexin peptide is expressed in human endocrine and epithelial tissues and reduced after glucose load in type 2 diabetes

Spexin mRNA and protein are widely expressed in rat tissues and associate with weight loss in rodents of diet-induced obesity. Its location in endocrine and epithelial cells has also been suggested. Spexin is a novel peptide that involves weight loss in rodents of diet-induced obesity. Therefore, we aimed to examine its expression in human tissues and test whether spexin could have a role in glucose and lipid metabolism in type 2 diabetes mellitus (T2DM). The expression of the spexin gene and immunoreactivity in the adrenal gland, skin, stomach, small intestine, liver, thyroid, pancreatic islets, visceral fat, lung, colon, and kidney was higher than that in the muscle and connective tissue. Immunoreactive serum spexin levels were reduced in T2DM patients and correlated with fasting blood glucose (FBG, r=-0.686, P<0.001), hemoglobin A1c (HbA1c, r=-0.632, P<0.001), triglyceride (TG, r=-0.236, P<0.001) and low density lipoprotein-cholesterol (LDL-C, r=-0.382, P<0.001). A negative correlation of blood glucose with spexin was observed during oral glucose tolerance test (OGTT). Spexin is intensely expressed in normal human endocrine and epithelial tissues, indicating that spexin may be involved in physiological functions of endocrine and in several other tissues. Circulating spexin levels are low in T2DM patients and negatively related to blood glucose and lipids suggesting that the peptide may play a role in glucose and lipid metabolism in T2DM.
Comparison of Self-Expanding Metal Stents and Urgent Surgery for Left-Sided Malignant Colonic Obstruction in Elderly Patients

Acute left-sided malignant colonic obstruction is common in elderly patients and multiple treatment options exist. To date, the use of self-expanding metallic stents (SEMS) in elderly patients has not been adequately described. The purpose of this study was to compare mortality, avoidance of stoma, and short-term survival in elderly patients with malignant bowel obstruction treated with either colonic stenting or surgery. In this retrospective review, elderly patients with acute left-sided colonic obstruction cancer underwent either insertion of a SEMS (n = 34) or primary surgery (n = 58). The two groups were compared for clinic variables, surgical procedures and outcome, acute mortality, and complications. Both groups were similar in terms of age, sex, tumor distribution, ASA grade, and comorbidities. The SEMS were successful placed in 91% of patients,and surgery was effective in relieving obstruction in 100% of the patients. Primary anastomosis was 79% in the SEMS group compared to 47% in the primary surgery group (P = 0.002). Secondary reanastomosis was 31% in the primary surgery group but only 3% in the SEMS surgery group (P = 0.001). Patients in the SEMS group had less 30-day mortality compared to the primary surgery group (3% vs. 19%, P = 0.03). Postoperative complications were similar. In elderly patients with acute left-sided colonic obstruction cancer due to colorectal cancer, SEMS provide an effective and safe therapeutic option compared to emergent surgery.
Switching to boosted protease inhibitor plus a second antiretroviral drug (dual therapy) for treatment simplification: a multicenter observational study

Aim of the study was to assess predictors of discontinuation/toxicity of boosted PI-based (PI/r) dual therapy (DT).



Observational, retrospective switch study in patients successfully treated with triple drugs regimen. Patients switched to PI/r based DT [darunavir (DRV/r), lopinavir (LPV/r) or atazanavir (ATV/r)] plus a second drug: [raltegravir (RAL), maraviroc (MVC) etravirine (ETR), lamivudine (3TC) or tenofovir (TDF)] between 2009 and 2014 were included. The effect of each drug as well as other clinical and virological cofactors over treatment discontinuation (TD) was assessed using survival analysis.



Overall, 376 patients were included with mean follow-up of 73 weeks. The most commonly used drugs in DT were DRV/r (63.0 %) and RAL (53.7 %). TD was observed in 77 (20,4 %) patients: 38 (10,1 %) virological failure, 35 (9,3 %) toxicity/intolerance (4 deaths) and 4 (1 %) interruptions for patients decision. At Cox Model, adjusted by demographic and laboratory variables, DRV/r and ATV/r significantly reduced the likelihood of TD and longer treatment was associated with lower risk, while low CD4 count at baseline and number of previous regimens with a higher risk. Moreover, RAL and 3TC use were significantly associated with lower TD by toxicity.



In our clinical practice experience, switching virologically suppressed patients to PI/r based DT showed adequate safety and efficacy, so that it may be used in selected patients with specific medical needs.
Yoga might be an alternative training for the quality of life and balance in postmenopausal osteoporosis.

Osteoporotic vertebra and hip fractures are major causes of dysfunction, disability, mortality and impaired life quality in the ageing population. In the postmenopausal period, exercises prevent rapid bone loss and increase muscle strength, mobility and flexibility thereby decreasing the risk of falls and fractures. Yoga exercises, which have been an inseparable part of Eastern culture for hundreds of years, are now being used in the field of osteoporosis rehabilitation. Yoga has a positive effect on balance, posture, flexibility, and life quality resulting from its effects on balance, stretching, relaxation and strengthening. The aim of this study was to evaluate the effect of yoga exercises in postmenopausal osteoporotic women on balance and life quality and to compare the results with a classic osteoporosis exercise program.



Twenty-six postmenopausal osteoporotic women over 55 years of age were included in the study. A neuromuscular test battery and the QUALEFFO as a life quality index were used for the assessment of balance and life quality, respectively.



The results showed that yoga education has a positive effect on pain, physical functions, social functions, general



In conclusion, yoga appears to be an alternative physical activity for the rehabilitation of osteoporotic subjects.
Inhibition of joint damage and improved clinical outcomes with rituximab plus methotrexate in early active rheumatoid arthritis: the IMAGE trial.

Rituximab is an effective treatment in patients with established rheumatoid arthritis (RA). The objective of the IMAGE study was to determine the efficacy of rituximab in the prevention of joint damage and its safety in combination with methotrexate (MTX) in patients initiating treatment with MTX.



In this double-blind randomised controlled phase III study, 755 MTX-naïve patients with active RA were randomly assigned to MTX alone, rituximab 2×500 mg + MTX or rituximab 2×1000 mg + MTX. The primary end point at week 52 was the change in joint damage measured using a Genant-modified Sharp score.



249, 249 and 250 patients were randomly assigned to MTX alone, rituximab 2×500 mg + MTX or rituximab 2×1000 mg + MTX, respectively. At week 52, treatment with rituximab 2×1000 mg + MTX compared with MTX alone was associated with a reduction in progression of joint damage (mean change in total modified Sharp score 0.359 vs 1.079; p=0.0004) and an improvement in clinical outcomes (ACR50 65% vs 42%; p<0.0001); rituximab 2×500 mg + MTX improved clinical outcomes (ACR50 59% vs 42%; p<0.0001) compared with MTX alone but did not significantly reduce the progression of joint damage. Safety outcomes were similar between treatment groups.



Treatment with rituximab 2×1000 mg in combination with MTX is an effective therapy for the treatment of patients with MTX-naïve RA.
A phase I study with an expanded cohort to assess feasibility of intravenous docetaxel, intraperitoneal carboplatin and intraperitoneal paclitaxel in patients with previously untreated ovarian, fallopian tube or primary peritoneal carcinoma: a Gynecologic Oncology Group study.

To define the maximum tolerated dose (MTD) and assess the feasibility of intravenous (IV) docetaxel, intraperitoneal (IP) carboplatin and IP paclitaxel in women with stage II-IV untreated ovarian, fallopian tube or primary peritoneal carcinoma.



Patients received docetaxel (55-75 mg/m(2)) IV and carboplatin (AUC 5-7) IP on day 1 and paclitaxel 60 mg/m(2) IP on day 8. A standard 3+3 design was used in the dose escalation phase. A 2-stage group sequential design with 20 patients at the MTD was used in the feasibility phase.



The MTD determined during the dose escalation phase was day 1 docetaxel 75 mg/m(2) IV, carboplatin AUC 6 IP and day 8 IP paclitaxel 60 mg/m(2). Forty-six patients were enrolled in the feasibility portion at this dose level. Six were unevaluable. Fifteen evaluable patients had dose-limiting toxicities (DLTs) within the first four cycles. These DLTs were prolonged neutropenia (2), neutropenic fever (7), grade 4 thrombocytopenia (1), grade 4 dehydration (1), grade 3 infection (2), grade 3 oral mucositis (1) and pulmonary embolism (1).



Docetaxel 75 mg/m(2) IV, carboplatin AUC 6 IP administered on day 1, and paclitaxel 60 mg/m(2) IP administered on day 8, is the MTD when considering one cycle of treatment but was not feasible over four cycles due to bone marrow toxicity. We recommend reduction of carboplatin to AUC 5 should this regimen be considered for treatment in women with newly diagnosed advanced ovarian cancer.