nils-herrmann/clean_scirepeval huggingface dataset:
D-Cycloserine Augmentation of Exposure Therapy for Post-Traumatic Stress Disorder: A Pilot Randomized Clinical Trial

Viewing post-traumatic stress disorder (PTSD) as a disorder of emotional learning, this study used a cognitive enhancer synergistically with virtual reality exposure (VRE) therapy for the treatment of PTSD. The main objective was to determine if a novel pharmacotherapy, D-cycloserine (DCS), enhanced the efficacy of the psychotherapy. Pre-clinical studies suggest that when fear extinction occurs during DCS administration, neuroplasticity may be enhanced. VRE therapy is a particularly promising format to test the hypothesis that DCS enhances extinction learning, as sensory fear cues are standardized across patients. In a pilot randomized, double-blind, placebo-controlled trial, 100 mg of DCS or placebo was administered 90 min before each weekly VRE session, to ensure peak plasma concentrations during the sessions in 25 patients with chronic PTSD. The primary outcome measure was the Clinician Administered PTSD Scale (CAPS). Secondary outcome measures included the Beck Depression Inventory-II and the State-Trait Anger Expression Inventory-2. Assessments occurred at pre-treatment, following sessions 3, 6, 10, post-treatment, and at 6 months. The difference in CAPS between the VRE-DCS (n=13) and VRE-placebo (n=12) groups increased over time beginning at 6 weeks, with medium to large between-group effect sizes immediately post-treatment and 6 months later (d=0.68 and d=1.13, respectively). A similar pattern was observed for depression, anger expression, and sleep. PTSD remission rates were significantly greater for the VRE-DCS group (46% vs 8% at post-treatment; 69% vs 17% at 6 months). Patients in the VRE-DCS group showed earlier and greater improvement in PTSD symptoms compared with the VRE-placebo group. These results suggest a promising new treatment for PTSD.
Quality of life in patients with spinal cord injury receiving VIAGRA® (sildenafil citrate) for the treatment of erectile dysfunction

A multicenter, randomized, double-blind, placebo-controlled, flexible-dose, two-way crossover study conducted June 1996 through January 1997.Objectives: To evaluate the effect of sildenafil citrate (VIAGRA®) on the quality of life (QoL) of men with erectile dysfunction (ED) caused by spinal cord injury ( Study centers in Australia, Belgium, France, Germany, Norway, Sweden and the United Kingdom. Questions 13 and 14 of the 15-item International Index of Erectile Function (IIEF) addressed QoL issues directly related to ED in 178 men with SCI. A 5-item questionnaire addressing concerns that men had about their erection problems was also used to evaluate the impact of ED on QoL. Several commonly used psychometric instruments, including the Medical Outcomes Survey (MOS) Short Form-12, Psychological General Well-Being Index, and MOS Family Survey, assessed general QoL issues. Significant improvements were seen for overall satisfaction with sex life (IIEF Q13), sexual relationship with partner (IIEF Q14), and concerns about erectile problems (P<0.0001). Improvements were reported in scores for the generic QoL parameters of mental health, well-being, depression, and anxiety (P<0.05 sildenafil versus placebo).Conclusion: Treatment with sildenafil can significantly improve key QoL parameters in men with ED caused by SCI.Sponsorship: This study was funded by Pfizer Inc.
Improvement in healing and reduction in HIV shedding with episodic acyclovir therapy as part of syndromic management among men: a randomized, controlled trial.

It is uncertain whether episodic acyclovir will enhance ulcer healing if delivered at primary health care settings, because there is often a delay in treatment initiation.



A double-blind, randomized, placebo-controlled trial of 5-day acyclovir (400 mg 3 times daily) was conducted among men with genital ulcers in South Africa. Participants received syndromic management; were tested for ulcer etiology, human immunodeficiency virus (HIV), syphilis, and herpes simplex virus type 2 (HSV-2); and were seen over the course of a month to evaluate ulcer healing and HIV-1 RNA shedding. Outcomes were ulcer duration and HIV-1 RNA shedding, assessed on day 7 among HIV-1-seropositive participants with a herpetic ulcer.



A total of 309 men received acyclovir, and 306 received placebo; 63% were HIV-1 positive. There were 295 HIV-1-positive participants with a herpetic ulcer. Acyclovir improved ulcer healing--61% of those receiving acyclovir healed by day 7, compared with 42% of those receiving placebo (adjusted relative risk, 1.4 [95% confidence interval, 1.1-1.8]; P= .003). Acyclovir also improved healing by a median of 3 days (P= .002) and reduced HIV-1 ulcer shedding on day 7 (24% for acyclovir vs 37% for placebo; P= .05).



Addition of acyclovir to syndromic management will improve healing of genital ulcers and may potentially reduce HIV transmission in combination with other interventions.
Glucocorticoid-induced osteoporosis

Glucocorticoid induced osteoporosis (GC-OP) is the most important form of all secondary osteoporoses. Mainly from in vitro and animal studies a lot of information exists concerning the underlying pathogenetic mechanisms. Some findings are still controversial but it is generally accepted that the three most important mechanisms are inhibition of osteobastic matrix formation, stimulation of osteoclastic bone resorption and deterioration of intestinal calcium resorption with consecutive mild secondary hyperparathyreoidism. In the individual patients the time between the beginning of corticoid therapy and clinical manifestation of osteoporosis varies considerably. If there is really a threshold dosage of corticoids is still debated. Besides dosage and duration of steroids age, sex, other risk factors of osteroporosis and underlying disease may be important factors. In contrast to the clinical prominence of GC-OP only little experience exists in counteracting the detrimental effects of corticoids on bone tissue. For pure prevention it seems reasonable to overcome intestinal calcium malabsorption by calcium or vitamin D. Concerning treatment of manifest GC-OP we studied the effect of salmon calcitonin (sCT) in patients with chronic obstructive lung disease. 18 patients injected themselves 100 U sCT every second day subcutaneously while 18 randomized patients served as untreated controls. There was a significant pain reduction in the sCT group and after six months the mineral content of the distal radius had increased by 2.7% despite a daily mean intake of 16.2 mgs prednisone during that time. In the control group (mean daily prednisone dose 16.8 mgs) the mineral content decreased with 3.5% on the average (p<0.001).
Family planning and pregnancy issues for women with systemic inflammatory diseases: patient and physician perspectives

To identify family planning and pregnancy (FPP) issues for female patients of childbearing age living with a chronic inflammatory disease and to assess whether current clinical practice routinely provides adequate support to alleviate these concerns.



Multinational survey and an analysis of online patient activity.



Premenopausal women (aged 20-45 years; N=969) were surveyed in the USA, the UK, Germany, France, Italy and Spain. Rheumatologists were surveyed in Germany (N=50), France (N=50), Italy (N=50) and the USA (N=100), and gastroenterologists were also surveyed in the USA (N=100).



Two online surveys were undertaken to identify FPP issues for physicians and patients. The surveys examined the frequency of dialogue on these topics between physicians and patients, alongside assessment of patient satisfaction regarding these conversations. Online analysis identified key themes for patient discussion outside their doctors' office/clinic/surgery.



32-56% of physicians spontaneously reported having talked about FPP with their female patients of childbearing age. When prompted, the majority of rheumatologists (74-92%) and gastroenterologists (74%) reported having discussed conception/pregnancy with female patients; however, less than half reported consulting their patient's treating general practitioner/gynaecologist about these topics. The majority of patients reported their FPP-related concerns are not adequately addressed/settled during their medical appointments. Furthermore, only 30-40% of patients considered advice/information to be consistent across multiple healthcare professionals. Key online FPP-related patient discussions included disease state, adverse effects, treatment, switch behaviour and wash-out requirements.



Female patients who live with chronic inflammatory disease have important FPP concerns. The majority of patients, however, do not feel that their FPP concerns are adequately addressed in current clinical practice and report that they receive inconsistent advice from the various healthcare professionals who manage different aspects of their care. There is a clear need for provision of up-to-date and consistent information/support to female patients.
Rho GTPase-Activating Protein 35 rs1052667 Polymorphism and Osteosarcoma Risk and Prognosis

The Rho GTPase-activating protein 35 (ARHGAP35), an important Rho family GTPase-activating protein, may be associated with tumorigenesis of some tumors. Here, we investigated the relationship between an important polymorphic variant at 3'-UTR of this gene (rs1052667) and osteosarcoma risk and prognosis. This hospital-based case-control study, including 247 osteosarcoma patients and 428 age-, sex-, and race-matched healthy controls, was conducted in Guangxi population. Genotypes were tested using TaqMan PCR technique. We found a significant difference in the frequency of rs1052667 genotypes between cases and controls. Compared with the homozygote of rs1052667 C alleles (rs1052667-CC), the genotypes with rs1052667 T alleles (namely, rs1052667-CT or -TT) increased osteosarcoma risk (odds ratios: 2.41 and 7.35, resp.). Moreover, rs1052667 polymorphism was correlated with such pathological features of osteosarcoma as tumor size, tumor grade, and tumor metastasis. Additionally, this polymorphism also modified the overall survival and recurrence-free survival of osteosarcoma cases. Like tumor grade, ARHGAP35 rs1052667 polymorphism was an independent prognostic factor influencing the survival of osteosarcoma. These results suggest that ARHGAP35 rs1052667 polymorphism may be associated with osteosarcoma risk and prognosis.
Phase I and pharmacokinetic study of the (6-maleimidocaproyl)hydrazone derivative of doxorubicin.

The (6-maleimidocaproyl)hydrazone derivative of doxorubicin (DOXO-EMCH) is an albumin-binding prodrug of doxorubicin with acid-sensitive properties that shows superior antitumor efficacy in murine tumor models and a favorable toxicity profile in mice, rats, and dogs compared with doxorubicin. The purpose of the phase I study was to characterize the toxicity profile of DOXO-EMCH, establish a recommended dose for phase II studies, and assess potential anticancer activity.



A starting dose of 20 mg/m2 doxorubicin equivalents was chosen. Forty-one patients with advanced cancer disease were treated with an i.v. infusion of DOXO-EMCH once every 3 weeks at a dose level of 20 to 340 mg/m2 doxorubicin equivalents.



Treatment with DOXO-EMCH was well tolerated up to 200 mg/m2 without manifestation of drug-related side effects. Myelosuppression (grade 1-2) and mucositis (grade 1-2) were the predominant adverse effects at dose levels of 260 mg/m2 and myelosuppression (grade 1-3) as well as mucositis (grade 1-3) were dose limiting at 340 mg/m2. No cardiac toxicity was observed. Of 30 of 41 evaluable patients, 12 patients (40%) had progressive disease, 15 patients (57%) had stable disease, and 3 patients (10%) had a partial remission.



DOXO-EMCH showed a good safety profile and was able to induce tumor regressions in tumor types known to be anthracycline-sensitive tumors, such as breast cancer, small cell lung cancer, and sarcoma. The recommended doxorubicin equivalent dose for phase II studies is 260 mg/m2.
A multi-center study on the surgical management of metastatic disease to adrenal glands.

In the management of adrenal lesions in oncological patients, many issues are still controversial: morphological signs of suspected malignancy, accuracy of imaging examinations, use of fine needle aspiration (FNA), and the role of laparoscopy. The present study attempts to address these questions through the evaluation of the management of adrenal metastases (AM) in a wide cohort of patients included in the Italian Register of Endoscopic Adrenal Surgery.



In January 2009, all patients recorded on the Register were evaluated, on the basis of CT scan, MRI, and FNA. The diagnostic, surgical, and follow-up data of 95 patients with pre-operative AM diagnosis have been reviewed. On the basis of the fulfilled criteria three patterns were identified: "diagnostic", "suspect," and "non-diagnostic."



CT scan sensitivity was 41.5%/77.9% and specificity was 54.5%/90.9% for "diagnostic"/"diagnostic" + "suspect" examinations, respectively. MRI sensitivity was 15.7%/78.9% and specificity was non-determinate/83.3% for "diagnostic"/"diagnostic" + "suspect" exams, respectively. Sensitivity of FNA was 33.3%. About surgery, conversions rate was 16.6%; no mortality or re-operations were reported; complications rate was 10.7%; and no relation was noted between tumor size and surgical outcome. Mean survival was 32 months; 5-year survival was 23%, independent of AM size; survival for lung AM was similar to that of breast and kidney AM.



Laparoscopy for AM, in expert hand, seems to be a feasible and oncologically safe approach. Due to the unsatisfactory diagnostic accuracy for AM, every oncological patient with suspect adrenal lesions should be encouraged to undergo this surgical procedure.
Effects of contrast material on computed tomographic measurements of lung volumes in patients with acute lung injury

Intravenous injection of contrast material is routinely performed in order to differentiate nonaerated lung parenchyma from pleural effusion in critically ill patients undergoing thoracic computed tomography (CT). The aim of the present study was to evaluate the effects of contrast material on CT measurement of lung volumes in 14 patients with acute lung injury.



A spiral thoracic CT scan, consisting of contiguous axial sections of 10 mm thickness, was performed from the apex to the diaphragm at end-expiration both before and 30 s (group 1; n = 7) or 15 min (group 2; n = 7) after injection of 80 ml contrast material. Volumes of gas and tissue, and volumic distribution of CT attenuations were measured before and after injection using specially designed software (Lungview; Institut National des Télécommunications, Evry, France). The maximal artifactual increase in lung tissue resulting from a hypothetical leakage within the lung of the 80 ml contrast material was calculated.



Injection of contrast material significantly increased the apparent volume of lung tissue by 83 +/- 57 ml in group 1 and 102 +/- 80 ml in group 2, whereas the corresponding maximal artifactual increases in lung tissue were 42 +/- 52 ml and 31 +/- 18 ml.



Because systematic injection of contrast material increases the amount of extravascular lung water in patients with acute lung injury, it seems prudent to avoid this procedure in critically ill patients undergoing a thoracic CT scan and to reserve its use for specific indications.
Effect of Subcutaneous Dupilumab on Nasal Polyp Burden in Patients With Chronic Sinusitis and Nasal Polyposis: A Randomized Clinical Trial.

Dupilumab has demonstrated efficacy in patients with asthma and atopic dermatitis, which are both type 2 helper T-cell-mediated diseases.



To assess inhibition of interleukins 4 and 13 with dupilumab in patients with chronic sinusitis and nasal polyposis.



A randomized, double-blind, placebo-controlled parallel-group study conducted at 13 sites in the United States and Europe between August 2013 and August 2014 in 60 adults with chronic sinusitis and nasal polyposis refractory to intranasal corticosteroids with 16 weeks of follow-up.



Subcutaneous dupilumab (a 600 mg loading dose followed by 300 mg weekly; n = 30) or placebo (n = 30) plus mometasone furoate nasal spray for 16 weeks.



Change in endoscopic nasal polyp score (range, 0-8; higher scores indicate worse status) at 16 weeks (primary end point). Secondary end points included Lund-Mackay computed tomography (CT) score (range, 0-24; higher scores indicate worse status), 22-item SinoNasal Outcome Test score (range, 0-110; higher scores indicating worse quality of life; minimal clinically important difference ≥8.90), sense of smell assessed using the University of Pennsylvania Smell Identification Test (UPSIT) score (range, 0-40; higher scores indicate better status), symptoms, and safety.



Among the 60 patients who were randomized (mean [SD] age, 48.4 years [9.4 years]; 34 men [56.7%]; 35 with comorbid asthma), 51 completed the study. The least squares (LS) mean change in nasal polyp score was -0.3 (95% CI, -1.0 to 0.4) with placebo and -1.9 (95% CI, -2.5 to -1.2) with dupilumab (LS mean difference, -1.6 [95% CI, -2.4 to -0.7]; P < .001). The LS mean difference between the 2 groups for the Lund-Mackay CT total score was -8.8 (95% CI, -11.1 to -6.6; P < .001). Significant improvements with dupilumab were also observed for the 22-item SinoNasal Outcome Test (LS mean difference between groups, -18.1 [95% CI, -25.6 to -10.6]; P < .001) and sense of smell assessed by UPSIT (LS mean difference, 14.8 [95% CI, 10.9 to 18.7]; P < .001). The most common adverse events were nasopharyngitis (33% in the placebo group vs 47% in the dupilumab group), injection site reactions (7% vs 40%, respectively), and headache (17% vs 20%).



Among adults with symptomatic chronic sinusitis and nasal polyposis refractory to intranasal corticosteroids, the addition of subcutaneous dupilumab to mometasone furoate nasal spray compared with mometasone alone reduced endoscopic nasal polyp burden after 16 weeks. Further studies are needed to assess longer treatment duration, larger samples, and direct comparison with other medications.
Galantamine versus risperidone treatment of neuropsychiatric symptoms in patients with probable dementia: an open randomized trial.

To examine the effects of galantamine and risperidone on neuropsychiatric symptoms in dementia (NPSD) and global function.



Using a randomized, controlled and open-blind, one-center trial at an in- and outpatient clinic at a university hospital, we studied 100 adults with probable dementia and NPSD. Participants received galantamine (N = 50, target dose 24 mg) or risperidone (N = 50, target dose 1.5 mg) for 12 weeks. The primary outcome was effects on NPSD assessed by the Neuropsychiatric Inventory (NPI). Secondary measures included the Mini-Mental State Examination (MMSE), Clinical Dementia Rating, Clinical Global Impression, and Simpson Angus scales. All tests were performed before and after treatment.



Outcome measures were analyzed using analysis of covariance. Ninety-one patients (67% women, mean age 79 ± 7.5 years) with initial NPI score of 51.0 (± 25.8) and MMSE of 20.1 (± 4.6) completed the trial. Both galantamine and risperidone treatments resulted in improved NPSD symptoms and were equally effective in treating several NPI domains. However, risperidone showed a significant treatment advantage in the NPI domains irritation and agitation, F(1, 97) = 5.2, p = 0.02. Galantamine treatment also ameliorated cognitive functions where MMSE scores increased 2.8 points compared with baseline (95% confidence interval: 1.96-3.52). No treatment-related severe side effects occurred.



These results support that galantamine, with its benign safety profile, can be used as first-line treatment of NPSD symptoms, unless symptoms of irritation and agitation are prominent, where risperidone is more efficient.
A comparison between low intensity and reduced intensity conditioning in allogeneic hematopoietic stem cell transplantation for solid tumors.

Following different types of conditioning, allogeneic hematopoietic stem cell transplantation produces a graft-versus-tumor effect in patients with solid tumors. We performed a non-randomized study comparing low intensity conditioning with reduced intensity conditioning after stem cell transplantation to demonstrate the graft-versus-tumor effect.



Allogeneic stem cell transplantation was performed in 48 patients with metastatic renal cell cancer (n=17), colo-rectal cancer (n=15), non-metastatic advanced primary liver cancer after orthotopic liver transplantation (n=11), and other solid tumors (n=5). Tumor response was determined based on the international response evaluation criteria for solid tumors (RECIST).



No significant difference in the incidence of graft rejection was found between the low intensity conditioning and reduced intensity conditioning groups. Engraftment occurred earlier in the low intensity conditioning group than in the reduced intensity conditioning group (median 0 vs. 16 days, respectively; p<0.001). Complete donor chimerism in B cells occurred earlier after low intensity conditioning than after reduced intensity conditioning (median 28 vs. 97 days, respectively; p<0.001). No significant difference in the incidence of tumor response was found between groups receiving the different types of the conditioning. The most favorable tumor response rate was found in patients who received donor lymphocyte infusions and developed chronic graft-versus-host disease (75% vs. 34%, p=0.003). The best graft-versus-tumor effect was demonstrated in patients with advanced primary liver cancer who had previously undergone liver transplantation (p=0.018). Patients receiving reduced intensity conditioning had a tendency to better overall survival compared to the low intensity conditioning group (30% vs. 17%, p=0.005).



Adjuvant cell therapy with donor lymphocyte infusion may augment the graft-versus-tumor effect of chronic graft-versus-host disease. Patients with limited tumor load are indicated for allogeneic stem cell transplantation and reduced intensity conditioning may be favorable compared to low intensity conditioning.
A multicenter phase II study of the stop-and-go modified FOLFOX6 with bevacizumab for first-line treatment of patients with metastatic colorectal cancer

Currently, no prospective data exists to support a “stop-and-go” modified FOLFOX6 regimen with bevacizumab in metastatic colorectal cancer (mCRC) patients. This study aimed to evaluate the efficacy and safety of this regimen in first-line mCRC patients. Eligible patients (age ≥20 years) had previously untreated mCRC; Eastern Cooperative Oncology Group performance status of 0–2; and adequate hematologic, hepatic, and renal function. The modified FOLFOX6 regimen and bevacizumab (5 mg/kg) was administered intravenously every 2 weeks. After 8 cycles, patients received maintenance therapy with simplified LV5FU2 and bevacizumab until completion of 8 cycles or disease progression. After maintenance therapy, patients received another 8 cycles of modified FOLFOX6 with bevacizumab until completion of 8 cycles or disease progression. We recruited 50 patients between August 2007 and January 2009. The overall response rate was 48% (80% confidence interval [CI]; 38.2–58) with outcomes as follows: complete response, n = 1; partial response, n = 23; stable disease, n = 21; progression, n = 1; and not evaluated, n = 4. Median time to treatment failure was 7.7 months (80% CI: 6.2–8.0), and median progression-free survival was 12.8 months (80% CI: 10.8–14). Grade 3/4 toxicities included neutropenia (40%), nausea (4%), diarrhea (14%), thrombosis (4%), and hypertension (4%) et al. Grade 1, 2, or 3 peripheral neuropathy was reported in 38%, 40%, and 10% of patients, respectively. The stop-and-go modified FOLFOX6 and bevacizumab regimen is effective and well tolerated as first-line chemotherapy for mCRC patients.