nils-herrmann/clean_scirepeval huggingface dataset:
Pretreatment evaluation of carcinomas of the hypopharynx and larynx with 18F-fluorodeoxyglucose, 123I-α-methyl-L-tyrosine and 99mTc-hexakis-2-methoxyisobutylisonitrile

While fluorine-18 2-fluoro-2-deoxy-D-glucose (FDG) positron emission tomography (PET) is helpful in the pretherapeutic evaluation of head and neck cancer, it is only available in selected centres. Therefore, single-photon emission tomography (SPET) tracers would be desirable if they were to demonstrate tumour uptake reliably. This multitracer study was performed to evaluate the pretherapeutic uptake of the SPET tracers iodine-123 α-methyl-L-tyrosine (IMT) and technetium-99m hexakis-2-methoxyisobutylisonitrile (99mTc-MIBI) in primary carcinomas of the hypopharynx and larynx and to compare the results with those of FDG PET. We examined 22 fasted patients (20 male, 2 female, mean age 60.5±10.2 years) with histologically confirmed carcinoma of the hypopharynx (n=9) or larynx (n=13), within 1 week before therapy. In 20 patients a cervical PET scan was acquired after intravenous injection of 232±43 MBq 18F-FDG. Data analysis was semiquantitative, being based on standardised uptake values (SUVs) obtained at 60–90 min after injection. After injection of 570±44 MBq 99mTc-MIBI, cervical SPET scans (high-resolution collimator, 64×64 matrix, 64 steps, 40 s each) were obtained in 19 patients, 15 and 60 min after tracer injection. Finally, 15 min after injection of 327±93 MBq 123I-IMT (medium-energy collimator, 64×64 matrix, 64 steps, 40 s each) SPET scans were acquired in 15 patients. All images were analysed visually and by calculating the tumour to nuchal muscle ratio. Eighteen of 20 (90%) carcinomas showed an increased glucose metabolism, with a mean SUV of 8.7 and a mean carcinoma to muscle ratio of 7.3. The IMT uptake was increased in 13 of 15 (87%) patients, who had a mean carcinoma to muscle ratio of 2.9. Only 13 of 19 (68%) carcinomas revealed pathological MIBI uptake, with a mean tumour to muscle ratio of 2.2 and no significant difference between early and late MIBI SPET images (P=0.23). In conclusion, in the diagnosis of primary carcinomas of the hypopharynx and larynx, IMT SPET achieved a detection rate comparable to that of FDG PET. IMT SPET was clearly superior to MIBI SPET in this population. A further evaluation of the specificity of IMT in a larger number of patients appears justified.
The health impact of an online heart disease support group: a comparison of moderated versus unmoderated support.

The aim of this study was to assess whether our online closed community heart care support group and information resource could sustain changes in health behaviour after the moderators withdrew their support. Heart patients (n = 108) living in a deprived area of Greater Manchester were recruited from general practitioners' coronary heart disease registries. The sample for this randomized controlled trial was divided in half at random where half of the participants received password-protected access to our health portal and the other half did not. At 6 months follow-up (based on the moderated phase), there was a significant difference between the experimental group and the controls in terms of self-reported diet (eating bad foods less often). This change in behaviour was not sustained during the 3-month unmoderated phase. During this unmoderated phase of the intervention, the experimental group had significantly more health care visits compared with the controls. There was no significant difference between the two phases for either group in terms of exercise, smoking or social support. This study offers insight into the potential implications for health changes of moderating arrangements for online health communities.
The intramuscular administration of granulocyte colony-stimulating factor as an adjunct to chemotherapy in pretreated ovarian cancer patients: an Italian Trials in Medical Oncology (ITMO) Group pilot study.

No published data are available concerning the activity and tolerability of intramuscularly administered granulocyte colony-stimulating factor (G-CSF) in humans. To fill this gap, 19 patients with advanced ovarian cancer previously treated with at least one first-line chemotherapy cycle received the following myelosuppressive regimen: mitoxantrone (DHAD) 12 mg m-2 i.v. on day 1; ifosfamide (IFO) 4 g m-2 i.v. on days 1 and 2; mesna 800 mg m-2 i.v. t.i.d. on days 1 and 2. G-CSF (Filgrastim) was given at a dose of 5 micrograms/kg/day i.m. from day 6 to day 19, its pharmacokinetics being assessed in five patients. The neutrophil nadir was observed after a mean period of 8 days, and the neutrophil count was < 1.0 x 10(3) mm-3 for a mean of 6 days during the cycle of chemotherapy. The neutrophil count fell after the withdrawal of G-CSF on the 19th day of treatment. The difference in absolute neutrophil count between day 19 and day 21 was statistically significant (P = 0.0001); nevertheless, at day 21 no WHO grade 3-4 neutropenia was reported. DHAD and IFO were respectively given at 95% and 93% of the planned dose. The pharmacokinetics of G-CSF i.m. seems to be similar to that of the drug given subcutaneously. No evidence of cumulative myelosuppression was observed. G-CSF was well tolerated and no complications were observed at the injection sites. In conclusion, if the results obtained in this pilot study regarding the activity of i.m. G-CSF are confirmed by a randomised trial, the intramuscular administration of G-CSF could become a valid alternative for patients who dislike the subcutaneous route and who are being treated with chemotherapy that does not induce profound thrombocytopenia.
Phase I trial of edatrexate plus carboplatin in advanced solid tumors: amelioration of dose-limiting mucositis by ice chip cryotherapy

Edatrexate (10-Edam) is a methotrexate analog with improved intracellular transport, polyglutamation, and antitumor activity compared to the parent compound. Edatrexate shows schedule-dependent synergism with platinum compounds in preclinical studies. We performed a phase I trial to determine toxicities and establish the maximum tolerated dose (MTD) of edatrexate in combination with carboplatin. Based on the short initial plasma half-life of edatrexate, prophylactic ice chip cryotherapy was used to reduce the severity of mucositis.  Forty-six chemotherapy-naive patients with advanced solid tumors were treated. Edatrexate was given weekly for 5 doses (50% on day 8), and then every other week, followed by carboplatin at a fixed dose of 350 mg/m2 on day 1 and then every 4 weeks for 8 cycles. Edatrexate dose was increased at increments of 10 mg/m2/dose level beginning at 60 mg/m2/week (range 60–120 mg/m2).  All patients were assessable for toxicity and response analysis. The median number of cycles administered per patients was 4. This combination chemotherapy regimen was well tolerated. Using ice chip cryotherapy, no grade IV mucositis was observed. Grade III mucositis occurred in only 7/46 pts and was not dose-related. Protocol-defined dose-limiting toxicity occurred at a edatrexate dose level of 120 mg/m2, yielding an MTD of 110 mg/m2. Responding tumor types included non-small cell and small lung cancer, head and neck cancer, and bladder cancer.  1) This phase I study demonstrated the safety and tolerability of this edatrexate and carboplatin combination. 2) Dose-limiting mucositis did not occur allowing escalation of edatrexate dose above levels previously achieved with this edatrexate dose schedule. This was most likely a result of prophylactic ice chip cryotherapy. 3) An edatrexate dose of 110 mg/m2 with ice chip cryotherapy is recommended for Phase II trials of this combination.
Pharmacogenomic analysis of cytogenetic response in chronic myeloid leukemia patients treated with imatinib.

To better understand the molecular basis of cytogenetic response in chronic myeloid leukemia patients treated with imatinib, we studied gene expression profiles from a total of 100 patients from a large, multinational Phase III clinical trial (International Randomized Study of IFN-alpha versus STI571).



Gene expression data for >12,000 genes were generated from whole blood samples collected at baseline (before imatinib treatment) using Affymetrix oligonucleotide microarrays. Cytogenetic response was determined based on the percentage of Ph(+) cells from bone marrow following a median of 13 months of treatment.



A genomic profile of response was developed using a subset of individuals that exhibited the greatest divergence in cytogenetic response; those with complete response (0% Ph(+) cells; n = 53) and those with minimal or no response (>65% Ph(+) cells; n = 13). A total of 55 genes was identified that were differentially expressed between these two groups. Using a "leave-one-out" strategy, we identified the optimum 31 genes from this list to use as our genomic profile of response. Using this genomic profile, we were able to distinguish between individuals that achieved major cytogenetic response (0-35% Ph(+) cells) and those that did not, with a sensitivity of 93.4% (71 of 76 patients), specificity of 58.3% (14 of 24 patients), positive predictive value of 87.7%, and negative predictive value of 73.7%.



Interestingly, many of the genes identified appear to be strongly related to reported mechanisms of BCR-ABL transformation and warrant additional research as potential drug targets. The validity and clinical implications of these results should be explored in future studies.
A randomized trial of multivitamin supplementation in children with tuberculosis in Tanzania

Children with tuberculosis often have underlying nutritional deficiencies. Multivitamin supplementation has been proposed as a means to enhance the health of these children; however, the efficacy of such an intervention has not been examined adequately.



255 children, aged six weeks to five years, with tuberculosis were randomized to receive either a daily multivitamin supplement or a placebo in the first eight weeks of anti-tuberculous therapy in Tanzania. This was only 64% of the proposed sample size as the trial had to be terminated prematurely due to funding constraints. They were followed up for the duration of supplementation through clinic and home visits to assess anthropometric indices and laboratory parameters, including hemoglobin and albumin.



There was no significant effect of multivitamin supplementation on the primary endpoint of the trial: weight gain after eight weeks. However, significant differences in weight gain were observed among children aged six weeks to six months in subgroup analyses (n=22; 1.08 kg, compared to 0.46 kg in the placebo group; 95% CI=0.12, 1.10; p=0.01). Supplementation resulted in significant improvement in hemoglobin levels at the end of follow-up in children of all age groups; the median increase in children receiving multivitamins was 1.0 g/dL, compared to 0.4 g/dL in children receiving placebo (p<0.01). HIV-infected children between six months and three years of age had a significantly higher gain in height if they received multivitamins (n=48; 2 cm, compared to 1 cm in the placebo group; 95% CI=0.20, 1.70; p=0.01; p for interaction by age group=0.01).



Multivitamin supplementation for a short duration of eight weeks improved the hematological profile of children with tuberculosis, though it didn't have any effect on weight gain, the primary outcome of the trial. Larger studies with a longer period of supplementation are needed to confirm these findings and assess the effect of multivitamins on clinical outcomes including treatment success and growth failure.
Survival in patients with myocardial infarction complicated by out-of-hospital cardiac arrest undergoing emergency percutaneous coronary intervention.

We sought to evaluate the clinical outcomes of patients with myocardial infarction (MI) complicated by out-of-hospital cardiac arrest (OHCA) undergoing percutaneous coronary intervention (PCI).



Controversy remains regarding the benefit of early PCI in patients with MI complicated by OHCA.



We analyzed the outcomes of 88 consecutive patients presenting with MI complicated by OHCA compared to 5101 patients with MI without OHCA who underwent PCI from the Melbourne Interventional Group registry between 2004 and 2009.



Patients with OHCA had a higher proportion of ST-elevation MI presentations (90.9% vs. 50%, p<0.01) and were more likely to be to be in cardiogenic shock (38.6% vs. 4.6%, p<0.01). Procedural success was similar in the two groups (95.5% OHCA vs. 96.5% non-OHCA MI cohort, p=0.65). In-hospital, 30-day, and 1-year survival in the OHCA cohort versus the non-OHCA MI cohort were 62.5% vs. 97.2% (p<0.01), 61.4% vs. 96.5% (p<0.01), and 60.2% vs. 94.2% (p<0.01), respectively. Within the OHCA cohort, presentation with cardiogenic shock (OR 7.2, 95% CI: 2.7-18.8; p<0.01) was strongly associated with in-hospital mortality. Importantly, 1-year survival of patients discharged alive from hospital was similar between the two groups (96% vs. 97% p=0.8).



Patients with MI complicated by OHCA remain a high-risk group associated with high mortality. However, high procedural success rates similar to non-OHCA patients can be attained. Survival rates better than previously reported were observed with an emergent PCI approach, with 1-year survival comparable to a non-OHCA cohort if patients survive to hospital discharge.
Use of an 'evidence-based implementation' strategy to implement evidence-based care of asthma into rural district hospital emergency departments.

To determine if an evidence-based implementation (EBI) could lead to the successful implementation of evidence based care for adult asthma in small rural district hospitals.



A controlled trial involving eight small rural hospitals (four each in the study and control groups) was conducted. Retrospective pre-intervention audits were conducted at all eight hospitals for 7 months (1 January 2004 to 31 July 2004) and evidence-practice gaps identified. An EBI was then used to implement established guidelines for the management of asthma in the study hospitals. Post-intervention audits were then performed over a period of 7 months (1 October 2004 to 31 April 2005).



There were 52 presentations of asthma in the study hospitals in the pre-implementation phase and 47 post-implementation. The corresponding numbers for the control hospitals were 46 and 42 respectively. There were no statistically significant differences in the severity between the groups. Following the EBI there were significant improvements at the study hospitals for the documentation of severity (8% to 62%, p <0.001), use of spirometry (12% to 62%, p <0.001) and the use of written short-term asthma plans (9% to 26%, p = 0.05). There was a decrease in use of ipratropium in mild asthma (44% to 30%, p = 0.228), an increase in the use of systemic steroids (61% to 72%, p = 0.255) and no change in prescribing antibiotics for afebrile patients with asthma (21% to 21% p = 0.956). There was no significant change in practice at the control hospitals except for a decrease in the use of systemic steroids (48% to 21%, p = 0.011). For the six clinical indicators aggregate there was a significant increase in compliance with guidelines at the study hospitals (36% to 62%, p < 0.001) but no change at the control hospitals (31% to 31%, p = 0.970).



The pre-intervention audits demonstrated low levels of compliance with asthma guidelines across six clinical indicators. An EBI significantly improved compliance across these six indicators, and no improvement was noted in the control hospitals. This study demonstrates that an EBI can alter clinical practice in small rural district hospitals.
Relations between pregnancy-related low back pain, pelvic floor activity and pelvic floor dysfunction

To assess the occurrence of pelvic floor dysfunction (PFD) in pregnancy- related low back and pelvic pain (PLBP) patients, a cross-sectional study was performed, comprising 77 subjects. Each subject underwent physical assessment, and filled in the Urogenital Distress Inventory completed with gynaecological questions. Differences in the presence of PFD between PLBP patients and healthy controls as well as differences in pelvic floor muscle activity were tested for significance. Interaction by age and vaginal delivery were tested. PFD occurred in 52% of all PLBP patients, significantly more than in the healthy control group. In PLBP patients a significantly increased activity of the pelvic floor muscles could be demonstrated with respect to healthy controls. The occurrence of PFD and PLBP was influenced by a confounding effect of age. Clinicians should be aware of the relation between PLBP and PFD and hence address both problems at the same time.
Acute Care Utilization by Dementia Caregivers Within Urban Primary Care Practices

Caring for an individual with Alzheimer’s dementia (AD) is stressful, and studies show that this stress has an impact on both the physical and mental health of the caregiver. However, many questions remain about the characteristics of AD patients and their caregivers that contribute to this stress and how it impacts caregivers’ use of healthcare resources. To study the impact of stress on the physical and mental health of the caregiver. Patients underwent extensive testing to allow description of their degree of cognitive impairment, behavioral and psychological symptoms, medical comorbidities, and functional abilities. Caregivers were assessed for depressive symptoms and also for emergency department (ED) use and hospitalizations in the previous six months. Multivariate logistic regression was used to evaluate impact of patients’ dementia symptoms on caregivers’ acute care utilization. One hundred and fifty-three AD patients and their caregivers attending two large, urban, university-affiliated primary care practices were enrolled in a cross-sectional study to examine the facets of dementia caregiving that impact caregiver acute health care utilization. Twenty-four percent of the caregivers had at least one ED visit or hospitalization in the six months prior to enrollment. After adjusting for caregiver age, gender, and education, our logistic regression model found that the caregivers’ acute care utilization was associated with their depression as measured by the PHQ-9 (OR 1.09, 95% CI 1.00–1.18), the patients’ behavioral and psychological symptoms as measured by the NPI (OR 1.04, 95% CI 1.01–1.08), and the patients’ functional status as measured by the ADCS-ADL (OR 1.05, 95% CI 1.01–1.09). To improve the health of AD caregivers, a primary care system needs to reallocate resources to manage the functional, behavioral, and psychological symptoms related to the care-recipients suffering from AD.
A comparison of the impact of isotope ((125)I vs. (103)Pd) on toxicity and biochemical outcome after interstitial brachytherapy and external beam radiation therapy for clinically localized prostate cancer.

To compare biochemical outcomes and morbidity associated with iodine-125 ((125)I) and palladium-103 ((103)Pd) brachytherapy as part of combined modality therapy for clinically localized prostate cancer.



Between October 2002 and December 2008, 259 patients underwent prostate brachytherapy ((125)I prescription dose, 110Gy: n=199; (103)Pd prescription dose, 100Gy: n=60) followed by external beam radiotherapy (median dose, 50.4Gy). Eighty-seven patients also received neoadjuvant androgen deprivation therapy. Toxicities were recorded with CTCAE v 3.0, International Prostate Symptoms Score (IPSS), and International Index of Erectile Function questionnaires.



Overall, acute Grade ≥2 genitourinary toxicity occurred in 21% and 30% of patients treated with (125)I and (103)Pd, respectively (p=0.16). There were no significant differences in IPSS change or urinary quality-of-life scores between the isotopes at 4, 6, or 12 months (p=0.20, 0.21, and 1.0, respectively). IPSS resolution occurred at a median of 11 and 6 months for (125)I and (103)Pd patients, respectively (p=0.03). On multivariate analysis, only the use of neoadjuvant androgen deprivation therapy was predictive of time to IPSS resolution (p=0.046). Late Grade ≥2 gastrointestinal toxicity occurred in 7% of (125)I patients and 6% of patients treated with (103)Pd. Of 129 potent patients at baseline, there was better erectile function in patients who received (103)Pd (p=0.02); however, the followup was shorter for these patients. The 5-year prostate-specific antigen relapse-free survival for (125)I and (103)Pd patients was 95.2% and 98.2% (p=0.73), respectively.



There were no differences in acute or long-term genitourinary or gastrointestinal toxicity between (125)I and (103)Pd in combined modality therapy for prostate cancer. There may be less erectile toxicity with the use of (103)Pd; however, additional followup of these patients is needed. There was no significant difference in 5-year prostate-specific antigen relapse-free survival between (103)Pd and (125)I.
Coronary computed tomography angiography for early triage of patients with acute chest pain: the ROMICAT (Rule Out Myocardial Infarction using Computer Assisted Tomography) trial.

This study was designed to determine the usefulness of coronary computed tomography angiography (CTA) in patients with acute chest pain.



Triage of chest pain patients in the emergency department remains challenging.



We used an observational cohort study in chest pain patients with normal initial troponin and nonischemic electrocardiogram. A 64-slice coronary CTA was performed before admission to detect coronary plaque and stenosis (>50% luminal narrowing). Results were not disclosed. End points were acute coronary syndrome (ACS) during index hospitalization and major adverse cardiac events during 6-month follow-up.



Among 368 patients (mean age 53 +/- 12 years, 61% men), 31 had ACS (8%). By coronary CTA, 50% of these patients were free of coronary artery disease (CAD), 31% had nonobstructive disease, and 19% had inconclusive or positive computed tomography for significant stenosis. Sensitivity and negative predictive value for ACS were 100% (n = 183 of 368; 95% confidence interval [CI]: 98% to 100%) and 100% (95% CI: 89% to 100%), respectively, with the absence of CAD and 77% (95% CI: 59% to 90%) and 98% (n = 300 of 368, 95% CI: 95% to 99%), respectively, with significant stenosis by coronary CTA. Specificity of presence of plaque and stenosis for ACS were 54% (95% CI: 49% to 60%) and 87% (95% CI: 83% to 90%), respectively. Only 1 ACS occurred in the absence of calcified plaque. Both the extent of coronary plaque and presence of stenosis predicted ACS independently and incrementally to Thrombolysis In Myocardial Infarction risk score (area under curve: 0.88, 0.82, vs. 0.63, respectively; all p < 0.0001).



Fifty percent of patients with acute chest pain and low to intermediate likelihood of ACS were free of CAD by computed tomography and had no ACS. Given the large number of such patients, early coronary CTA may significantly improve patient management in the emergency department.