nils-herrmann/clean_scirepeval huggingface dataset:
Relationship of HIV reservoir characteristics with immune status and viral rebound kinetics in an HIV therapeutic vaccine study.

The objective of this study is to evaluate the impact of therapeutic HIV vaccination on the HIV reservoir and assess the relationship of the viral reservoir with HIV-specific immune status and viral rebound kinetics.



A retrospective analysis of ACTG A5197, a randomized, placebo-controlled trial of a therapeutic rAd5 HIV-1 gag vaccine.



Participants received vaccine/placebo at weeks 0, 4 and 26 prior to a 16-week analytic treatment interruption (ATI) at week 38. Cell-associated HIV-1 RNA and DNA (CA-RNA and CA-DNA) and HIV-1 residual viremia were quantified at weeks 0, 8 and 38. HIV-specific CD4(+)/CD8(+) activity was assessed by an intracellular cytokine staining assay.



At study entry, CA-RNA and CA-DNA levels were correlated inversely with the numbers of HIV-specific CD4(+) interferon-γ producing cells (CA-RNA: r = -0.23, P = 0.03 and CA-DNA: r = -0.28, P < 0.01, N = 93). Therapeutic HIV vaccination induced HIV-specific CD4(+) activity, but did not significantly affect levels of CA-RNA or CA-DNA. Vaccine recipients with undetectable residual viremia at week 8 had higher frequencies of HIV-specific CD4(+) and CD8(+) interferon-γ producing cells (undetectable versus detectable residual viremia: 277 versus 161 CD4(+) cells/10(6) lymphocytes, P = 0.03 and 1326 versus 669 CD8(+) cells/10 lymphocytes, P = 0.04). Pre-ATI CA-RNA and CA-DNA were associated with post-ATI plasma HIV set point (CA-RNA: r = 0.51, P < 0.01 and CA-DNA: r = 0.47, P < 0.01).



Vaccine-induced T-cell responses were associated with a modest transient effect on residual viremia, but more potent immune responses and/or combination treatment with latency-reversing agents are needed to reduce the HIV reservoir. HIV reservoir measures may act as biomarkers of post-ATI viral rebound kinetics.
Preprandial repaglinide decreases exogenous insulin requirements and HbA1c levels in type 2 diabetic patients taking intensive insulin treatment

In this study, we investigated the effects of combining preprandial repaglinide to the insulin therapy for reducing the exogenous insulin requirements and serum HbA1c levels in type 2 diabetic patients whose blood glucose levels were previously regulated by multiple dose intensive insulin therapy. Fifty patients with type 2 diabetes who had been initially treated with oral antidiabetic agents without a satisfactory response were included in this study. After adequate glycemic control was achieved with intensive insulin therapy, the patients were divided into two subgroups. The first group continued with intensive insulin therapy. The second group received a combination of multiple insulin injections and oral repaglinide (1.5 mgr tid). The doses of insulin injections were gradually decreased accordingly in the second group. Both groups were followed-up for 3 months. Repaglinide was well tolerated and had no toxicity. A significant reduction regarding exogenous insulin requirements and serum HbA1c levels were demonstrated in patients taking preprandial repaglinide (p<0.01). Combining repaglinide to intensive insulin therapy could be a safe and effective alternative to intensive insulin therapy alone for the glycemic control and for reducing exogenous insulin requirements in type 2 diabetic patients.
Technetium-99m-labelled red blood cell imaging in the diagnosis of hepatic haemangiomas: the role of SPECT/CT with a hybrid camera

Delayed liver single-photon emission computed tomography (SPECT) after 99mTc red blood cell (RBC) labelling is helpful in detecting hepatic haemangiomas; however, diagnosis can be difficult when lesions are situated adjacent to structures like the inferior vena cava, the heart or hepatic vessels, where blood activity persists. The aims of this study were to evaluate the usefulness of RBC SPECT and transmission computed tomography (RBC SPECT/CT) performed simultaneously with a hybrid imaging system for correct characterisation of hepatic lesions in patients with suspected haemangioma, and to assess the additional value of fused images compared with SPECT alone. Twelve patients with 24 liver lesions were studied. The acquisitions of both anatomical (CT) and functional (SPECT) data were performed during a single session. SPECT images were first interpreted alone and then re-evaluated after adding the transmission anatomical maps. Image fusion was successful in all patients, with perfect correspondence between SPECT and CT data, allowing the precise anatomical localisation of sites of increased blood pool activity. SPECT/CT had a significant impact on results in four patients (33.3%) with four lesions defined as indeterminate on SPECT images, accurately characterising the hot spot foci located near vascular structures. In conclusion, RBC SPECT/CT imaging using this hybrid SPECT/CT system is feasible and useful in the identification or exclusion of suspected hepatic haemangiomas located near regions with high vascular activity.
Randomised clinical trial: macrogol/PEG 3350+electrolytes versus prucalopride in the treatment of chronic constipation -- a comparison in a controlled environment.

Constipation is a common condition for which PEG 3350 is an established treatment and prucalopride has recently been approved for this indication.



To compare the efficacy, safety and impact on quality of life (QoL) of PEG 3350 plus electrolytes (PEG 3350+E) vs. prucalopride in females with chronic constipation (CC) in whom laxatives have previously failed to provide adequate relief.



In this single-centre, randomised, double-blind, double-dummy study, patients with CC [<3 spontaneous complete bowel movements (SCBM)/week] remained in a controlled environment and received either a 26 g split dose of PEG 3350+E (N = 120) or 1-2 mg prucalopride (N = 120) daily for 28 days following a 14-day run-in period. The primary endpoint was the proportion of patients having ≥3 SCBMs during the last treatment week.



Non-inferiority of PEG 3350+E to prucalopride was demonstrated in the per-protocol population [difference, 10.1% (66.67% vs. 56.52%), 97.5% lower confidence interval (CI) -2.7%, above the preset margin of -20%] and approached superiority in the modified intent-to-treat population (difference, 9.8%, 97.5% lower CI, -3.1%). Statistically significant differences in favour of PEG 3350+E were observed for most secondary variables (bowel movements, stool weight, consistency, time to next SCBM, patient perception of straining and completeness of defecation). Colonic transit time was dramatically reduced in both arms. Both treatments were well tolerated.



PEG 3350+E was at least as effective as and generally better tolerated than prucalopride as a treatment for chronic constipation in this study population (NCT01251822; http://www.clinicaltrials.gov).
Hematologic and hepatic toxicities associated with antenatal and postnatal exposure to maternal highly active antiretroviral therapy among infants.

To assess hematologic and hepatic toxicities associated with in utero and breastfeeding exposure to maternal highly active antiretroviral therapy (HAART) among infants in Botswana.



A nested cohort study within a randomized clinical trial (the Mashi Study). Laboratory toxicities among infants born to women who initiated HAART before delivery were compared with toxicities among those born to women who received zidovudine and a single dose of nevirapine or placebo in labor. Infants were randomized to breastfeed with extended zidovudine or to formula-feed.



Hemoglobin concentrations, absolute neutrophil and platelet counts, and alanine aminotransferase and aspartate aminotransferase levels were recorded from birth to 7 months of age in infants. Grade 3 and 4 toxicities were compared by infant antiretroviral exposure status.



In-utero exposure to maternal HAART was associated with increased risk for neutropenia in infants up to 1 month of age; 21.7% of HAART-exposed infants were neutropenic, compared with 5.5% of the infants exposed to zidovudine (P < 0.01). However, neutropenia was no longer associated with antenatal exposure to HAART after 1 month of age. Postnatal exposure to HAART was not associated with hematologic or hepatic toxicities. Laboratory toxicities were clinically asymptomatic in all but one infant.



Exposure to maternal HAART in utero may increase the risk for infant neutropenia, particularly among breastfed infants, but the clinical significance of this finding is uncertain. The lack of association between exposure to HAART through breastfeeding and long-term toxicities in infants is reassuring but deserves study in larger cohorts.
Home-based asthma education of young low-income children and their families.

To conduct a controlled trial of a home-based education program for low-income caregivers of young children with asthma.



Participants were randomized to treatment-eight weekly asthma education sessions adapted from the Wee Wheezers program (n = 49)-or usual care (n = 46). Baseline and 3- and 12-month follow-up data were gathered from caregivers and from children's medical records.



Treatment was associated with less bother from asthma symptoms, more symptom-free days, and better caregiver quality of life at follow-up for children 1-3, but not those 4-6, years of age. Treatment and control groups did not differ in caregiver asthma management behavior or children's acute care utilization.



This home-based asthma education program was most effective with younger children; perhaps their caregivers were more motivated to learn about asthma management. Targeting psychosocial factors associated with asthma morbidity might also enhance the efficacy of asthma education for these families.
Explaining Physical Activity Maintenance After a Theory-Based Intervention Among Patients With Rheumatoid Arthritis: Process Evaluation of a Randomized Controlled Trial.

Regular physical activity (PA) benefits patients with rheumatoid arthritis (RA), particularly when maintained over time. Research in this area has largely focused on factors associated with initiating PA, while factors contributing to PA maintenance, particularly after lifestyle interventions, have received less attention. This study examined whether higher levels of autonomous motivation, self-efficacy for PA, and greater use of self-regulation skills mediated PA initiation and maintenance 6 months after a theory-based motivational interviewing and self-regulation coaching intervention.



Seventy-eight individuals with RA were randomized to receive either a patient-education session (control group), or the patient-education session plus 1 motivational interview and 2 self-regulation coaching sessions (treatment group). Mediation analyses examined the effects of this intervention on PA initiation and maintenance through the intermediate variables autonomous motivation, self-efficacy for PA, and use of self-regulation skills. Analyses were controlled for age, sex, and previous levels of PA.



The treatment group reported significantly higher autonomous motivation and greater use of self-regulation skills than controls at posttreatment. Increases in PA from baseline to posttreatment were not mediated by any intermediate variables. However, maintenance of PA from posttreatment to followup (6 months later) was mediated by greater autonomous motivation and use of self-regulation skills.



Greater autonomous motivation and use of self-regulation skills predict maintenance of PA following a motivational interviewing and self-regulation coaching intervention. In promoting PA among patients with RA, supporting patient autonomy and teaching self-regulation skills, which focus attention on achieving PA goals, may improve long-term maintenance of PA.
Coaching intervention as a strategy for minority recruitment to cancer clinical trials.

Lack of trust and rapport with health care providers has been identified in the under-representation of racial/ethnic minorities within clinical trials. Our study used a coach to promote trust among minority patients with advanced cancer.



Minority patients with advanced breast, colorectal, lung, or prostate carcinoma were randomly assigned to receive a coach Intervention (CI) or usual care (UC). All patients completed baseline and 6-month telephone interviews to assess demographics, trust in health care providers, attitudes toward clinical trials, and quality of life. Patients randomly assigned to CI were assigned a coach, who made biweekly contacts for 6 months to address general issues, progress or development in cancer care, and available resources. Patients randomly assigned to UC received the standard of care, without this intervention. Clinical trial enrollment was assessed.



Over 21 months, we screened 268 patients and enrolled 73 African Americans and two Asian Americans. Patients were randomly assigned to CI (n = 38) or to UC (n = 37). Longitudinal analyses were conducted on 69 patients who completed the 6-month follow-up assessment. Trial enrollment was 16 and 13 patients for the CI and UC groups, respectively. This difference was not significant (P = .351). Higher quality of life (1-point odds ratio on Functional Assessment of Cancer Treatment-General = 1.033, P = .036) and positive attitudes toward trials predicted enrollment. There was no significant difference between these groups in quality of life, attitudes toward clinical trials, perceptions of racism, trust in doctors, or depression.



Quality of life and positive attitude toward trials predicted trial enrollment, regardless of assignment to CI or UC.
Development and external validation of nomograms predicting distant metastases and overall survival after neoadjuvant chemotherapy and surgery for patients with nonmetastatic osteosarcoma: A multi‐institutional study

In this era of individualized cancer treatment, data that could be applied to predicting the survival of patients with osteosarcoma are still limited because of the rarity of the disease and the difficulty in accumulating a sufficient number of patients. Therefore, a multi-institutional collaboration was implemented to develop and externally validate nomograms that would predict metastasis-free survival (MFS) and overall survival (OAS) for patients with nonmetastatic osteosarcoma.



This study retrospectively examined 1070 patients treated with neoadjuvant chemotherapy and surgery for nonmetastatic osteosarcoma. Data from Japanese patients (n = 557) were used to develop multivariate nomograms based on Cox regression. Six clinical and pathologic variables were built into nomograms estimating the probability of MFS and OAS 3 and 5 years after diagnosis. The model was internally validated for discrimination and calibration with bootstrap resampling and was externally validated with an independent patient cohort from Korea (n = 513).



A patient's age, tumor site, and histologic response were found to have a stronger influence on MFS and OAS in the model than sex, tumor size, or pathologic fracture. The nomograms and calibration plots based on these results well predicted the probability of MFS (concordance index, 0.631) and OAS (concordance index, 0.679). The concordance indices for external validation were 0.682 for MFS and 0.665 for OAS.



The nomograms were externally validated and verified to be useful for the prediction of MFS and OAS and for the assessment of the postoperative prognosis. They can be used for counseling patients and for establishing appropriate surveillance strategies after surgery.
Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study.

Severe acetaminophen hepatotoxicity frequently leads to acute liver failure (ALF). We determined the incidence, risk factors, and outcomes of acetaminophen-induced ALF at 22 tertiary care centers in the United States. Detailed prospective data were gathered on 662 consecutive patients over a 6-year period fulfilling standard criteria for ALF (coagulopathy and encephalopathy), from which 275 (42%) were determined to result from acetaminophen liver injury. The annual percentage of acetaminophen-related ALF rose during the study from 28% in 1998 to 51% in 2003. Median dose ingested was 24 g (equivalent to 48 extra-strength tablets). Unintentional overdoses accounted for 131 (48%) cases, intentional (suicide attempts) 122 (44%), and 22 (8%) were of unknown intent. In the unintentional group, 38% took two or more acetaminophen preparations simultaneously, and 63% used narcotic-containing compounds. Eighty-one percent of unintentional patients reported taking acetaminophen and/or other analgesics for acute or chronic pain syndromes. Overall, 178 subjects (65%) survived, 74 (27%) died without transplantation, and 23 subjects (8%) underwent liver transplantation; 71% were alive at 3 weeks. Transplant-free survival rate and rate of liver transplantation were similar between intentional and unintentional groups. In conclusion, acetaminophen hepatotoxicity far exceeds other causes of acute liver failure in the United States. Susceptible patients have concomitant depression, chronic pain, alcohol or narcotic use, and/or take several preparations simultaneously. Education of patients, physicians, and pharmacies to limit high-risk use settings is recommended.
N-Acetyl Cysteine for Depressive Symptoms in Bipolar Disorder—A Double-Blind Randomized Placebo-Controlled Trial

Treatment-resistant subthreshold depression is a major problem in bipolar disorder. Both depression and bipolar disorder are complicated by glutathione depletion. We hypothesized that treatment with N-acetyl cysteine (NAC), a safe, orally bioavailable precursor of glutathione, may improve the depressive component of bipolar disorder.



A randomized, double-blind, multicenter, placebo-controlled study of individuals (n = 75) with bipolar disorder in the maintenance phase treated with NAC (1 g twice daily) adjunctive to usual medication over 24 weeks, with a 4-week washout. The two primary outcomes were the Montgomery Asberg Depression Rating Scale (MADRS) and time to a mood episode. Secondary outcomes included the Bipolar Depression Rating Scale and 11 other ratings of clinical status, quality of life, and functioning.



NAC treatment caused a significant improvement on the MADRS (least squares mean difference [95% confidence interval]: -8.05 [-13.16, -2.95], p = .002) and most secondary scales at end point. Benefit was evident by 8 weeks on the Global Assessment of Functioning Scale and Social and Occupational Functioning Assessment Scale and at 20 weeks on the MADRS. Improvements were lost after washout. There was no effect of NAC on time to a mood episode (log-rank test: p = .968) and no significant between-group differences in adverse events. Effect sizes at end point were medium to high for improvements in MADRS and 9 of the 12 secondary readouts.



NAC appears a safe and effective augmentation strategy for depressive symptoms in bipolar disorder.
Most patients with minimal histological residuals of gastric MALT lymphoma after successful eradication of Helicobacter pylori can be managed safely by a watch and wait strategy: experience from a large international series.

Eradication of Helicobacter pylori is the established initial treatment of stage I MALT (mucosa associated lymphoid tissue) lymphoma. Patients with minimal persisting lymphoma infiltrates after successful eradication of H pylori are considered treatment failures and referred for radiation, chemotherapy, immunotherapy, or surgery.



To report a watch and wait strategy in such patients.



108 patients were selected from a larger series of patients treated at various European institutions. Their mean age was 51.6 years (25 to 82), and they were all diagnosed as having gastric marginal zone B cell lymphoma of MALT type stage I. After successful H pylori eradication and normalisation of the endoscopic findings, lymphoma infiltrates were still present histologically at 12 months (minimal histological residuals). No oncological treatment was given but the patients had regular follow up with endoscopies and multiple biopsies.



Based on a follow up of 42.2 months (2-144), 102 patients (94%) had a favourable disease course. Of these, 35 (32%) went into complete remission. In 67 (62%) the minimal histological residuals remained stable and no changes became evident. Local lymphoma progression was seen in four patients (5%), and one patient developed a high grade lymphoma.



Most patients with minimal histological residuals of gastric MALT lymphoma after successful eradication of H pylori had a favourable disease course without oncological treatment. A watch and wait strategy with regular endoscopies and biopsies appears to be safe and may become the approach of choice in this situation. Longer follow up is needed to establish this definitively.
A neuro-oncology workstation for structuring, modeling, and visualizing patient records

The patient medical record contains a wealth of information consisting of prior observations, interpretations, and interventions that need to be interpreted and applied towards decisions regarding current patient care. Given the time constraints and the large---often extraneous---amount of data available, clinicians are tasked with the challenge of performing a comprehensive review of how a disease progresses in individual patients. To facilitate this process, we demonstrate a neuro-oncology workstation that assists in structuring and visualizing medical data to promote an evidence-based approach for understanding a patient's record. The workstation consists of three components: 1) a structuring tool that incorporates natural language processing to assist with the extraction of problems, findings, and attributes for structuring observations, events, and inferences stated within medical reports; 2) a data modeling tool that provides a comprehensive and consistent representation of concepts for the disease-specific domain; and 3) a visual workbench for visualizing, navigating, and querying the structured data to enable retrieval of relevant portions of the patient record. We discuss this workstation in the context of reviewing cases of glioblastoma multiforme patients.
Effectiveness of the integrated long-term program of management of patients after first psychotic episode in 5-year follow-up.

The Early Intervention Centre (First episode clinic, FEC) that provides specific service programs to this particular target group of patients with early psychosis opened in November 2000 as a day clinic at the Moscow Research Institute of Psychiatry. To date, FEC programs consistent with the developed model have been established in 30 regions across Russia. 5-year follow-up data are available for 114 patients who received such care in the FEC. In more than 30% of cases complete remission was maintained over the 5 years. The number of relapses increased on the 2nd and 3rd years, but later decreased more than by one half. The relapses were mostly treated in day clinic or outpatient settings and did not require hospital admissions. More than 73% of the patients maintained their social achievements with no losses. By the end of the 5th year only 1/5 of the cases were formally recognized as unemployable due to psychiatric disability. Significantly better clinical and psychosocial outcomes have been shown in comparison with a control group of patients, treated in routine psychiatric services.