nils-herrmann/clean_scirepeval huggingface dataset:
Factors Associated with Negative Direct Sputum Examination in Asian and African HIV-Infected Patients with Tuberculosis (ANRS 1260)

To identify factors associated with negative direct sputum examination among African and Cambodian patients co-infected by Mycobacterium tuberculosis and HIV.



Prospective multicenter study (ANRS1260) conducted in Cambodia, Senegal and Central African Republic.



Univariate and multivariate analyses (logistic regression) were used to identify clinical and radiological features associated with negative direct sputum examination in HIV-infected patients with positive M. tuberculosis culture on Lowenstein-Jensen medium.



Between September 2002 and December 2005, 175 co-infected patients were hospitalized with at least one respiratory symptom and pulmonary radiographic anomaly. Acid-fast bacillus (AFB) examination was positive in sputum samples from 110 subjects (63%) and negative in 65 patients (37%). Most patients were at an advanced stage of HIV disease (92% at stage III or IV of the WHO classification) with a median CD4 cell count of 36/mm³. In this context, we found that sputum AFB negativity was more frequent in co-infected subjects with associated respiratory tract infections (OR = 2.8 [95%CI:1.1-7.0]), dyspnea (OR = 2.5 [95%CI:1.1-5.6]), and localized interstitial opacities (OR = 3.1 [95%CI:1.3-7.6]), but was less frequent with CD4 ≤ 50/mm³ (OR = 0.4 [95%CI:0.2-0.90), adenopathies (OR = 0.4 [95%CI:0.2-0.93]) and cavitation (OR = 0.1 [95%CI:0.03-0.6]).



One novel finding of this study is the association between concomitant respiratory tract infection and negative sputum AFB, particularly in Cambodia. This finding suggests that repeating AFB testing in AFB-negative patients should be conducted when broad spectrum antibiotic treatment does not lead to complete recovery from respiratory symptoms. In HIV-infected patients with a CD4 cell count below 50/mm3 without an identified cause of pneumonia, systematic AFB direct sputum examination is justified because of atypical clinical features (without cavitation) and high pulmonary mycobacterial burden.
The use of multiple respiratory inhalers requiring different inhalation techniques has an adverse effect on COPD outcomes

Patients with COPD may be prescribed multiple inhalers as part of their treatment regimen, which require different inhalation techniques. Previous literature has shown that the effectiveness of inhaled treatment can be adversely affected by incorrect inhaler technique. Prescribing a range of device types could worsen this problem, leading to poorer outcomes in COPD patients, but the impact is not yet known.



To compare clinical outcomes of COPD patients who use devices requiring similar inhalation technique with those who use devices with mixed techniques.



A matched cohort design was used, with 2 years of data from the Optimum Patient Care Research Database. Matching variables were established from a baseline year of follow-up data, and two cohorts were formed: a "similar-devices cohort" and a "mixed-devices cohort". COPD-related events were recorded during an outcome year of follow-up. The primary outcome measure was an incidence rate ratio (IRR) comparing the rate of exacerbations between study cohorts. A secondary outcome compared average daily use of short-acting beta agonist (SABA).



The final study sample contained 8,225 patients in each cohort (mean age 67 [SD, 10], 57% males, 37% current smokers). Patients in the similar-devices cohort had a lower rate of exacerbations compared with those in the mixed-devices cohort (adjusted IRR 0.82, 95% confidence interval [CI] 0.80-0.84) and were less likely to be in a higher-dose SABA group (adjusted proportional odds ratio 0.54, 95% CI 0.51-0.57).



COPD patients who were prescribed one or more additional inhaler devices requiring similar inhalation techniques to their previous device(s) showed better outcomes than those who were prescribed devices requiring different techniques.
Aprotinin reduces blood loss in off-pump coronary artery bypass (OPCAB) surgery.

Effects of aprotinin in off-pump coronary artery bypass (OPCAB) surgery have not yet been described. This study analyses hemostasiologic changes and potential benefit in OPCAB patients treated with aprotinin.



In a prospective, double-blind, randomized study 47 patients undergoing OPCAB surgery were investigated. Patients received either aprotinin (2 x 10(6) KIU loading dose and 0.5 x 10(6) KIU/h during surgery, n=22) or saline solution (control, n=25). Activated clotting time was adjusted to a target of 250 s intraoperatively. Blood samples were taken up to 18h postoperatively: complete hematologic and hemostasiologic parameters including fibrinopeptide A (FPA) and D-dimer in a subgroup of 31 patients were analyzed. Blood loss, blood transfusion and other clinical data were collected.



Both groups showed comparable demographic and intraoperative variables. Forty-one (87%) patients of the whole study group received aspirin within 7 days prior to surgery. Number of grafts per patient were comparable (2.9+/-1.0 [mean+/-SD] in the aprotinin group and 2.8+/-1.2 in control, P=0.83). Blood loss during the first 18 h in intensive care unit was significantly reduced in patients treated with aprotinin (median [25th-75th percentiles]: 500 [395-755] ml vs. 930 [800-1170] ml, P<0.001). Postoperatively only two patients (10%) in the aprotinin group received packed red blood cells, whereas eight (35%) in the control group (P=0.07). Perioperatively FPA levels reflecting thrombin generation were elevated in both groups. The increase in D-dimer levels after surgery was significantly inhibited in the aprotinin group (P<0.001). Early clinical outcome was similar in both groups.



Aprotinin significantly reduces blood loss in patients undergoing OPCAB surgery. Inhibition of enhanced fibrinolysis can be observed. FPA generation during and after OPCAB surgery seems not to be influenced by aprotinin.
In women with symptoms of cardiac ischemia, nonobstructive coronary arteries, and microvascular dysfunction, angiotensin-converting enzyme inhibition is associated with improved microvascular function: A double-blind randomized study from the National Heart, Lung and Blood Institute Women's Ischemia

We investigated the role of the renin-angiotensin system in women with signs and symptoms of ischemia without obstructive coronary artery disease (CAD). Although microvascular dysfunction has been suggested to explain this syndrome and recently was found to predict adverse outcomes, the mechanisms and treatments remain unclear.



In a substudy within the WISE, 78 women with microvascular dysfunction (coronary flow reserve [CFR] <3.0 following adenosine) and no obstructive CAD were randomly assigned to either an angiotensin-converting enzyme inhibition (ACE-I) with quinapril or a placebo treatment group. The primary efficacy parameter was CFR at 16 weeks adjusted for baseline characteristics and clinical site. The secondary response variable was freedom from angina symptoms assessed using the Seattle Angina Questionnaire.



A total of 61 women completed the 16-week treatment period with repeat CFR measurements, and treatment was well tolerated. For the primary outcome, at 16 weeks, CFR improved more with ACE-I than placebo (P < .02). For the secondary outcome of symptom improvement, ACE-I treatment (P = .037) and CFR increase (P = .008) both contributed.



Microvascular function improves with ACE-I therapy in women with signs and symptoms of ischemia without obstructive CAD. This improvement is associated with reduction in angina. The beneficial response of the coronary microvasculature was limited to women with lower baseline CFR values, suggesting that the renin-angiotensin system may be more involved among women with more severe microvascular defects.
Cortical vessel imaging and visualization for image guided depth electrode insertion

To avoid intracranial hemorrhage during minimally invasive depth electrode insertion without craniotomy for epilepsy surgery, precise in vivo imaging of cortical vessel and relevant rendering methods are critical, and should be used in preoperative planning. In this study, a non-invasive phase contrast MR angiography (PC-MRA) method was chosen for cortical vessel imaging. After image pre-processing (registration and segmentation), three visualization methods were implemented to optimize the vessel imaging and brain tissue rendering for surgical planning. The processed results were evaluated by comparing with intraoperative photographs. The results showed occurrences of missing vessels between imaging and photos (18.3%, 6 cases), but these could be compensated by realistic sulci visualization methods. The results showed 3D texture mapping to be the most suitable cortex visualization method for use in surgical navigation. Based on the methods and evaluations, a new surgical planning system and criteria of usage were developed with input from the surgeons' experience using the prototype system. This system could greatly help reduce the risk of the intracranial hemorrhage during electrode insertion and also avoid potential risks caused by contrast agent injections for contrast enhanced MRA or CTA.
Diagnostic accuracy of the Composite International Diagnostic Interview (CIDI 3.0) PTSD module among female Vietnam-era veterans.

The World Health Organization (WHO) Composite International Diagnostic Interview (CIDI) posttraumatic stress disorder (PTSD) module is widely used in epidemiological studies of PTSD, yet relatively few data attest to the instrument's diagnostic utility. The current study evaluated the diagnostic utility of the CIDI 3.0 PTSD module with U. S. women Vietnam-era veterans. The CIDI and the Clinician-Administered PTSD Scale (CAPS) were independently administered to a stratified sample of 160 women, oversampled for current PTSD. Both lifetime PTSD and recent (past year) PTSD were assessed within a 3-week interval. Forty-five percent of the sample met criteria for a CAPS diagnosis of lifetime PTSD, and 21.9% of the sample met criteria for a CAPS diagnosis of past-year PTSD. Using CAPS as the diagnostic criterion, the CIDI correctly classified 78.8% of cases for lifetime PTSD (κ = .56) and 82.0% of past year PTSD cases (κ = .51). Estimates of diagnostic performance for the CIDI were sensitivity of .61 and specificity of .91 for lifetime PTSD and sensitivity of .71 and specificity of .85 for past-year PTSD. Results suggest that the CIDI has good utility for identifying PTSD, though it is a somewhat conservative indicator of lifetime PTSD as compared to the CAPS.
Development of difluoromethylornithine as a chemoprevention agent for the management of colon cancer.

Experimental studies have demonstrated that carcinogenesis is a multistep process in which inappropriate proliferation of cells is a critical determinant. Polyamines support sustained growth and are highly regulated in all cells. The rate limiting enzyme for this pathway is ornithine decarboxylase (ODC), an enzyme that exhibits rapid turnover, and converts the amino acid ornithine to putrescine, which in turn is converted to the longer chain amines spermidine and spermine. In animal models of colon carcinogenesis, inhibition of ODC by difluoromethylornithine (DFMO), an enzyme-activated irreversible inhibitor, reduces the number and size of colon adenomas and carcinomas. DFMO was first ineffective when used clinically to treat acute leukemia or melanoma and caused clinically significant but reversible ototoxicity. Subsequently, we performed a series of analyses demonstrating that hearing loss was rare below a total cumulative dose of 150 gm/m2 and increased with total cumulative dose of DFMO. The hearing loss was reversible with rapid reversion to baseline hearing. We and others have conducted Phase IIa trials to determine the lowest dose at which DFMO can decrease colon mucosa polyamine content, and found that an oral dose as low as 0.25 gm/m2 per day (perhaps lower) decreases colon tissue putrescine content and lowers the spermidine/spermine ratio. We are currently conducting a long-term randomized Phase IIb trial which serially measures the long-term effect of several low doses (and placebo) of DFMO on sustaining polyamine depletion in colon mucosa, as well as carefully monitoring hearing by audiometry and other sophisticated tests.(ABSTRACT TRUNCATED AT 250 WORDS)
Short-term cardiorespiratory effects of proportional assist and pressure-support ventilation in patients with acute lung injury/acute respiratory distress syndrome.

Recent data indicate that assisted modes of mechanical ventilation improve pulmonary gas exchange in patients with acute lung injury (ALI)/acute respiratory distress syndrome (ARDS). Proportional assist ventilation (PAV) is a new mode of support that amplifies the ventilatory output of the patient effort and improves patient-ventilator synchrony. It is not known whether this mode may be used in patients with ALI/ARDS. The aim of this study was to compare the effects of PAV and pressure-support ventilation on breathing pattern, hemodynamics, and gas exchange in a homogenous group of patients with ALI/ARDS due to sepsis.



Twelve mechanically ventilated patients with ALI/ARDS (mean ratio of partial pressure of arterial oxygen to fractional concentration of oxygen 190 +/- 49 mmHg) were prospectively studied. Patients received pressure-support ventilation and PAV in random order for 30 min while maintaining mean airway pressure constant. With both modes, the level of applied positive end-expiratory pressure (7.1 +/- 2.1 cm H2O) was kept unchanged throughout. At the end of each study period, cardiorespiratory data were obtained, and dead space to tidal volume ratio was measured.



With both modes, none of the patients exhibited clinical signs of distress. With PAV, breathing frequency and cardiac index were slightly but significantly higher than the corresponding values with pressure-support ventilation (24.5 +/- 6.9 vs. 21.4 +/- 6.9 breaths/min and 4.4 +/- 1.6 vs. 4.1 +/- 1.3 l . min . m, respectively). None of the other parameters differ significantly between modes.



In patients with ALI/ARDS due to sepsis, PAV and pressure-support ventilation both have clinically comparable short-term effects on gas exchange and hemodynamics.
Variations in asthma treatment in five European countries--judgement analysis of case simulations.

The aim of this study was to explore and compare treatment decisions and the influence of specific patient characteristics on asthma management in five European countries, and to relate this to existing guidelines.



Using the technique of clinical judgement analysis, doctors in The Netherlands, Norway, Germany, Sweden and the Slovak Republic (40-100 doctors per country) were presented with sets of written simulated cases on asthma treatment. Patient characteristics were varied to determine their influence on the doctors' decisions. Decisions indicating over- and under-prescribing in relation to a gold standard derived from guidelines were also determined.



Doctors in The Netherlands prescribed more oral steroid courses and fewer antibiotics than doctors in Norway and Sweden, whereas doctors in Germany and the Slovak Republic prescribed the least oral steroids and the most antibiotics. Partially, this variation could be explained by differences in the underlying propensity to prescribe, but differences in the use of patient characteristics also contributed to the variation. Norwegian doctors were most inclined to increase the maintenance treatment of inhaled corticosteroids, which could best be explained by their relatively high focus on the patient's peak expiratory flow value. Compared with the gold standard, there was 25-56% under-prescribing of oral steroids, and 21-45% over-prescribing of antibiotics.



The variation in treatment of asthma patients between doctors in different countries may, in part, be attributed to variations in the underlying propensity to prescribe, and in part to different use of clinical patient characteristics. These findings can be used in tailoring educational programmes to improve treatment practices.
Modelling the cost-effectiveness of combination therapy for early, rapidly progressing rheumatoid arthritis by simulating the reversible and irreversible effects of the disease

To estimate the cost-effectiveness of adalimumab plus methotrexate (MTX) versus MTX monotherapy in early, aggressive rheumatoid arthritis (RA) when explicitly modelling short-term (reversible) and long-term (irreversible, ie, joint damage) disease activity and physical function.



A microsimulation model was developed to unify, in a single cost-effectiveness model, measures of reversible and irreversible disease activity and physical function based on data from the PREMIER trial. Short term, reversible disease activity was modelled using DAS28 variables, including swollen joint counts, tender joint counts, C reactive protein concentration and pain. The DAS28 variables were then used in a logistic regression to predict short-term American College of Rheumatology (ACR) responses, which informed treatment continuation and switches. Long term, irreversible, radiographically documented joint damage was modelled using modified Total Sharp Score (mTSS). The model then linked both short-term disease activity and mTSS to the Health Assessment Questionnaire score, which was used to calculate direct and indirect costs, and quality adjusted life-years (QALYs).



When both reversible and irreversible effects of therapy were included, combination therapy was estimated to produce 6-month 50% ACR responses in 75% of patients versus 54% in MTX monotherapy. Compared to MTX monotherapy, combination therapy resulted in 2.68 and 3.04 discounted life years and QALYs gained, respectively. Combination therapy also resulted in a net increase in direct costs of £106,207 for a resulting incremental cost/QALY gain of £32,425. When indirect costs were included in the analysis, the ICER (incremental cost-effectiveness ratio) decreased to £27,238. Disregarding irreversible effects increased the incremental cost-effectiveness ratio to £78,809 (when only direct costs were included).



Starting with adalimumab plus MTX combination therapy in early, aggressive RA is cost-effective when irreversible damage is adequately considered.
Caphosol(®) mouthwash gives no additional protection against oral mucositis compared to cryotherapy alone in stem cell transplantation. A pilot study.

To investigate if adding Caphosol(®), a mouthwash solution, to oral cryotherapy (OC) further protects against oral mucositis (OM), a toxic painful complication to high dose chemotherapy.



The study was a randomised, controlled, study design. Patients ≥16 years scheduled for allogeneic stem cell transplantation were included consecutively and randomised to experimental group receiving OC combined with Caphosol(®) (n = 20) or control group receiving OC only (n = 20). OC was given from start to end of HDCT. Caphosol(®), from day 0 to day 21.



There were no significant differences regarding age or gender between the groups. Mucositis was assessed with the World Health Organisation (WHO) grading scale. Pain was assessed with a 10 cm visual analogue scale (VAS) from 0 = no pain to 10 = worst imaginable pain. Start and duration of therapy with pain relieving drugs, serum C-reactive protein values, and number of days of hospitalisation were collected from the medical records. Data on OM, oral pain, use of i.v. opioids and total parenteral nutrition were collected during 22 days. There was no significant difference between the groups on OM, oral pain, use of i.v. opioids or TPN between the groups.



The study showed no additional effect of combining Caphosol(®) with OC.
Symptomatic cimetidine treatment of duodenal and prepyloric ulcers

In a randomized trial, 75 patients with an endoscopically confirmed and symptomatic duodenal (N=50) or prepyloric (N=25) ulcer were allocated to cimetidine treatment (1 g/day) either regularly for four weeks (standard treatment group) or regularly for a minimum of one week and thereafter only until the symptoms were controlled (symptomatic treatment group). The four-week healing frequencies in the standard and symptomatic treatment groups were 72 and 67%, respectively. The difference ±95% confidence limits was 5±21%. Prospective recording of pain revealed that the two treatment regimens were about equally effective in relieving symptoms during weeks 2–4. Patients with unhealed ulcers reported pain during the day and night significantly more often than those with healed ulcers. In the symptomatic treatment group the average patient saved 11 days of cimetidine medication during weeks 2–4. We believe that disappearance of symptoms might be a valuable means of deciding when treatment for peptic ulcers can be discontinued. Provided its efficacy and safety can be further confirmed, symptomatic treatment might become a practical and possibly a money-saving mode of ulcer management, which should also be applicable to the ulcer regimens of tomorrow.
Cognitive function in postmenopausal women receiving adjuvant letrozole or tamoxifen for breast cancer in the BIG 1-98 randomized trial.

Cognitive function in postmenopausal women receiving letrozole or tamoxifen as adjuvant endocrine treatment was compared during the fifth year of treatment in a substudy of the BIG 1-98 trial. In BIG 1-98 patients were randomized to receive adjuvant (A) 5-years tamoxifen, (B) 5-years letrozole, (C) 2-years tamoxifen followed by 3-years letrozole, or (D) 2-years letrozole followed by 3-years tamoxifen. The primary comparison was the difference in composite score for patients taking letrozole (B+C; N=65) vs. tamoxifen (A+D; N=55). The patients taking letrozole had better overall cognitive function than those taking tamoxifen (difference in mean composite z-scores=0.28, P=0.04, 95% CI: 0.02, 0.54, Cohen's D=0.40 indicating small to moderate effect). In this substudy, breast cancer patients taking adjuvant letrozole during the fifth year of treatment had better cognitive function than those taking tamoxifen, suggesting aromatase inhibitors do not adversely impact cognition compared with tamoxifen.
Outcome Following Thiopurine Use in Children With Ulcerative Colitis: A Prospective Multicenter Registry Study

Despite little supporting data, thiopurine use is common in pediatric ulcerative colitis (UC). Our aim was to determine outcome following thiopurine use in a multicenter inception cohort of children diagnosed with UC.METHODS:Data were obtained from a prospective observational study of newly diagnosed children <16 years of age. Data are recorded at diagnosis, 30 days, and quarterly. Patients are managed by physician dictates not protocol. Disease activity is classified by physician global assessment. The primary outcome was corticosteroid (CS)-free inactive UC at 1 year following thiopurine initiation without the need for rescue therapy (infliximab, calcineurin inhibitors, or colectomy).RESULTS:Of 1,490 patients in our registry, 394 have UC (mean age at diagnosis 11.3±3.7 years); 197 (50%) received thiopurine (49% ≤3 months from diagnosis). Also, 84% were receiving CSs and 60% 5-aminosalicylates at thiopurine start. Of the 197 patients, there was insufficient follow-up (41), previous or concomitant use of infliximab (16), or calcineurin inhibitor (7), leaving 133 patients evaluable at 1 year. Of these, 65 (49%) had CS-free inactive UC without rescue therapy. CS-free inactive disease at 1 year after initiating thiopurine was not affected by starting thiopurine ≤3 months vs. >3 months from diagnosis, gender, age, or concomitant treatment with 5-aminosalicylates. Kaplan–Meier analysis showed that the likelihood of remaining free of rescue therapy in the thiopurine-treated patients was 73% at 1 year.Approximately 50% of children with UC starting thiopurine without previous or concomitant biologic or calcineurin inhibitor therapy have CS-free inactive disease 1 year later without the need for rescue therapy.