bluuebunny/crossref_metadata_2025_split huggingface dataset:
Factors determining response to antiepileptic drugs in randomized controlled trials. A systematic review and meta‐analysis
Authors: Rheims Sylvain , Perucca Emilio , Cucherat Michel , Ryvlin Philippe 
Published: January 2011

SummaryPurpose: Because of the lack of head‐to‐head adjunctive‐therapy trials of antiepileptic drugs (AEDs) in refractory partial epilepsy, meta‐analyses of placebo‐controlled randomized controlled trials (RCTs) represent a potentially important source of evidence to guide treatment decisions. However, such indirect comparisons raise various methodologic issues that may hamper their relevance.Methods: All RCTs in adult refractory partial epilepsy were analyzed to assess whether efficacy outcomes are influenced by: characteristics of patients and trials ; use of last observation carried forward (LOCF) analysis; evaluation period (entire period versus maintenance period); and year of publication. A meta‐analysis of these AEDs was then performed taking these factors into consideration.Key Findings: Sixty‐three RCTs evaluating 20 AEDs were included. The following variables influenced efficacy estimates: (1) responder rates correlated positively with duration of the entire treatment period (p = 0.038); (2) response to placebo was significantly greater in the maintenance period than in the entire treatment period (p = 0.005); (3) responder rates increased over the years both for AEDs (p < 0.001) and for placebo (p = 0.001); (4) LOCF analysis overestimated responder rates for AEDs (p < 0.001) and for placebo (p = 0.001) compared with completer‐based analysis, and the overestimation correlated positively with withdrawal rates (p < 0.001). A meta‐analysis of available data showed large differences in efficacy ranking in relation to dose selection and type of analysis, but these were mostly nonsignificant due to statistical power limitations.Significance: Several methodologic issues hamper the relevance of indirect comparisons of AEDs in the adjunctive‐therapy of refractory partial epilepsy. Some of these issues could be overcome by improved standardization in the reporting of efficacy outcomes.
Cognitive development in Dravet syndrome: A retrospective, multicenter study of 26 patients
Authors: Ragona Francesca , Granata Tiziana , Bernardina Bernardo Dalla , Offredi Francesca , Darra Francesca , Battaglia Domenica , Morbi Monica , Brazzo Daniela , Cappelletti Simona , Chieffo Daniela , De Giorgi Ilaria , Fontana Elena , Freri Elena , Marini Carla , Toraldo Alessio , Specchio Nicola , Veggiotti Pierangelo , Vigevano Federico , Guerrini Renzo , Guzzetta Francesco , Dravet Charlotte 
Published: January 2011

SummaryPurpose:  To clarify the role of epilepsy and genetic background in determining the cognitive outcome of patients with Dravet syndrome.Methods:  In this retrospective study, we reviewed the clinical history and cognitive development of 26 patients who had been followed with standardized evaluations since seizure onset. The cognitive outcome was quantified as differential general quotient (dGQ) between ages 12 and 60 months. Statistical analysis correlated the dGQ with genotype and epilepsy course.Key Findings:  Epilepsy started at the mean age of 5.6 months. All patients experienced prolonged convulsive seizures, whereas absences and myoclonus were reported in 17. Cognitive outcome was poor in almost all patients; the mean dGQ was 33 points, varying from 6–77 points. The analysis of individual cognitive profiles identified seven patients in whom the dGQ was <20 points; the main clinical characteristic in this subset of patients was lack of early absences and myoclonus. The statistical analysis of the whole series failed to reveal significant differences in cognitive outcome with regard to the presence of SCN1A mutations and their type. In particular, mutation‐carrier patients with the best cognitive outcome harbored either missense or truncating mutations.Significance:  Dravet syndrome encompasses different epileptic and cognitive phenotypes that probably result from both genetic and epigenetic factors. In this series, early appearance of myoclonus and absences was associated with the worst cognitive outcome.
Comorbidities of epilepsy: Results from the Epilepsy Comorbidities and Health (EPIC) survey
Authors: Ottman Ruth , Lipton Richard B. , Ettinger Alan B. , Cramer Joyce A. , Reed Michael L. , Morrison Alan , Wan George J. 
Published: January 2011

SummaryPurpose:  To estimate the prevalence of neuropsychiatric and pain disorders in adults with epilepsy in the United States.Methods:  In 2008, an 11‐item survey including validated questions to screen for a lifetime history of epilepsy was mailed to 340,000 households from two national panels selected to be generally representative of the noninstitutionalized U.S. population. Information on epilepsy and other disorders was collected from 172,959 respondents aged 18 or older. Propensity scoring was used to match respondents with and without epilepsy on baseline characteristics and risk factors for epilepsy. Prevalence ratios (PRs) of comorbidities in respondents with epilepsy were calculated using log‐binomial generalized linear models. Comorbidities were categorized as neuropsychiatric (anxiety, depression, bipolar disorder, attention‐deficit/hyperactivity disorder, sleep disorder/apnea, and movement disorder/tremor), pain (migraine headache, chronic pain, fibromyalgia, neuropathic pain), and other (asthma, diabetes, and high blood pressure).Key Findings:  Two percent (3,488) of respondents reported ever having been told they had epilepsy or a seizure disorder. Respondents with self‐reported epilepsy were more likely (p < 0.001) than those without epilepsy to report all six neuropsychiatric disorders (PR from 1.27–2.39), all four pain disorders (PR 1.36–1.96), and asthma (PR 1.25).Significance:  Neuropsychiatric conditions and pain disorder comorbidities were reported more often in individuals with self‐reported epilepsy than in those without epilepsy. Identification of these conditions is an important consideration in the clinical management of epilepsy.
Bilateral hippocampal atrophy in temporal lobe epilepsy: Effect of depressive symptoms and febrile seizures
Authors: Finegersh Andrey , Avedissian Christina , Shamim Sadat , Dustin Irene , Thompson Paul M. , Theodore William H. 
Published: January 2011

SummaryPurpose:  Neuroimaging studies suggest a history of febrile seizures, and depression, are associated with hippocampal volume reductions in patients with temporal lobe epilepsy (TLE).Methods:  We used radial atrophy mapping (RAM), a three‐dimensional (3D) surface modeling tool, to measure hippocampal atrophy in 40 patients with unilateral TLE, with or without a history of febrile seizures and symptoms of depression. Multiple linear regression was used to single out the effects of covariates on local atrophy.Key Findings:  Subjects with a history of febrile seizures (n = 15) had atrophy in regions corresponding to the CA1 and CA3 subfields of the hippocampus contralateral to seizure focus (CHC) compared to those without a history of febrile seizures (n = 25). Subjects with Beck Depression Inventory II (BDI‐II) score ≥14 (n = 11) had atrophy in the superoanterior portion of the CHC compared to subjects with BDI‐II <14 (n = 29).Significance:  Contralateral hippocampal atrophy in TLE may be related to febrile seizures or depression.
Comparison of short‐ versus long‐term ketogenic diet for intractable infantile spasms
Authors: Kang Hoon‐Chul , Lee Yun Jin , Lee Joon Soo , Lee Eun Joo , Eom Soyong , You Su Jeong , Kim Heung Dong 
Published: January 2011

SummaryPurpose: To compare the prognoses between short‐term (8 months) and conventional long‐term (>2 years) trials involving patients with refractory infantile spasms who successfully completed the ketogenic diet (KD).Methods: Of 40 patients who achieved seizure‐free outcomes and showed improvement in hypsarrhythmic patterns within 6 months of the KD, with a 3:1 fat to nonfat ratio as an add‐on treatment, 16 patients were randomized into the short‐term trial group and the diet was tapered throughout two additional months. Twenty‐four patients were randomized into a long‐term trial group, and 19 patients could successfully discontinue the diet after 2 years. Primary outcome measures included seizure relapse and frequency of 35 patients for >12 months after successful completion of the KD.Key Findings: Of 16 patients in the short‐term trial group, two patients relapsed with clusters of spasms, and one patient had recurrence of occasional focal seizures. Of 19 patients in the long‐term trial group, two patients progressed to Lennox‐Gastaut syndrome and one patient experienced recurrence of occasional focal seizures with secondary generalization. An early response to the KD, evidenced by short latency before seizure freedom and disappearance of hypsarrythmia and cryptogenic etiology, may indicate a successful early discontinuation of the KD. Significant growth failure was complicated only in conventional long‐term trial group.Significance: Use of the KD for only 8 months in children who become spasm‐free appears to be justified, with similar outcomes, recurrence rate, and less growth disturbance than a longer‐term, traditional use.
Outcome of status epilepticus in children treated in the intensive care unit: A study of 302 cases
Authors: Kravljanac Ruzica , Jovic Nebojsa , Djuric Milena , Jankovic Borisav , Pekmezovic Tatjana 
Published: January 2011

SummaryPurpose:  The aim of the study was to evaluate the outcome of status epilepticus (SE) in children and to define predictors for morbidity, mortality, and SE recurrence.Methods:  The study included 302 children (age 2 months to less than 18 years; mean age ± SD 4.7 ± 4.2 years) with 489 episodes of SE. Etiology, treatment, and clinical and electroencephalography (EEG) features of SE and their impact on the outcome were analyzed. The outcome was classified into three categories: unchanged neurologic status, neurologic consequences, and lethal outcome. Univariate and multivariate Cox hazard regression analyses were used to define predictors of mortality, morbidity, and SE recurrence.Key Findings:  Neurologic status was unchanged in 235 children (77.8%) and neurologic consequences occurred in 39 patients (12.9%); case‐fatality ratio was 9.3% and recurrence rate was 21%. Mortality was related to progressive encephalopathy, preexisting neurologic abnormalities, specific EEG findings, and generalized convulsive type of SE. Neurologic consequences were associated with younger age, progressive encephalopathy, duration of SE >24 h, prior epilepsy, and specific EEG findings. Multivariate analyses showed that etiology of SE and prior neurologic abnormalities were independent predictors of mortality, whereas younger age, etiology, and very long duration of SE were predictors of morbidity.Significance:  Outcome of SE in children is favorable in most of the cases, but mortality and morbidity rates are still high. Etiology and prior neurologic abnormalities were the main predictors of mortality, whereas the main predictor of morbidity was underlying etiology.
A Survey of Obesity and Erectile Dysfunction of Men Conscripted into the Military in Taiwan
Authors: Chao Jian-Kang , Hwang Thomas I-Sheng , Ma Mi-Chia , Kuo Wu-Hsien , Liu Jiang-Hwa , Chen Yu-Ping , Lin Yen-Chin 
Published: January 2011

ABSTRACT

Introduction
Obesity is receiving growing research attention. However, investigations concerning the potential impact of obesity and testosterone on erectile dysfunction (ED) in young men have not been completely clarified.

Aim
To identify the relationship between ED, serum testosterone level, and obesity in draftees in Taiwan.

Methods
Data were obtained from a baseline survey of 364 young adult military conscripts (19–24 years old). Their demographic data, body mass index (BMI), serum testosterone, and ED status were assessed. Sixty-four subjects had ED, and 300 comprised the normal control group.

Main Outcome Measures
The International Index of Erectile Function-5 (IIEF-5), Sexual Desire Inventory, and Sexual Behavior Scale were used to assess ED, sexual desire, and sexual function.

Results
Three hundred sixty-four men were available for analysis. The mean age of the sample was 21.66 ± 0.92 years (19–24 years). The IIEF total score had a mean of 21.99 ± 2.34 and median of 23; 64 (17.6%) subjects had ED, although mild. The results showed an increased risk of ED among obese men and subjects with lower serum testosterone. Among the predictors of ED, obesity (odds ratio = 83.97, 95% CI = 16.17–436.03, degrees of freedom [d.f.] = 1, P &lt; 0.001) and lower serum testosterone (odds ratio = 679.84, 95% CI = 108.48–4,260.58, d.f. = 1, P &lt; 0.001) were significantly independent factors. Testosterone levels were lower in subjects with obesity (P &lt; 0.001).

Conclusions
This study supports the idea that BMI and serum testosterone may provide warning signs of ED and, at the same time, an opportunity for early intervention in young men.
Neural Supply to the Clitoris: Immunohistochemical Study with Three-Dimensional Reconstruction of Cavernous Nerve, Spongious Nerve, and Dorsal Clitoris Nerve in Human Fetus
Authors: Moszkowicz David , Alsaid Bayan , Bessede Thomas , Zaitouna Mazen , Penna Christophe , Benoit Gérard , Peschaud Frédérique 
Published: January 2011

ABSTRACT

Introduction
Little detailed information is available concerning autonomic and somatic nerve supply to the clitoris, potentially causing difficulties for nerve preservation during pelvic and perineal surgery.

Aim
To identify the location and type (nitrergic, adrenergic, cholinergic and sensory) of nerve fibers in the clitoris and to provide a three-dimensional (3D) representation of their structural relationship in the human female fetus.

Methods
Serial transverse sections were obtained from five human female fetuses (18–31 weeks of gestation) and subjected to histological and immunohistochemical investigations; digitized serial sections were used to construct a 3D representation of the pelvis.

Main Outcome Measures
Pelvic-perineal nerve location and type were evaluated qualitatively.

Results
The female neurovascular bundle (NVB) is the anteroinferior terminal portion of the inferior hypogastric plexus that runs along the postero-lateral then lateral face of the vagina and is rich in nNOS-positive fibers. The cavernous nerve (CN) is a thin ventrocaudal collateral projection of the NVB, and this projection does not strictly follow the NVB course. The CN runs along the lateral surface of the vagina and urethra and penetrates the homolateral clitoral crus. The CN provides adrenergic, cholinergic, and nitrergic innervation to the clitoris, but not sensory innervation. The spongious nerve (SN) is the terminal and main projection of the NVB and provides nitrergic innervation to the vestibular bulbs. The dorsal clitoris nerve (DCN), somatic branche of the pudendal nerve, runs along the superior surface of the clitoral crus and body and has a segmental proerectile nitrergic activity related to communicating branches with the CN.

Conclusions
“Computer-assisted anatomic dissection” allowed the identification of the precise location and distribution of the autonomic and somatic neural supply to female erectile bodies, providing an anatomical basis for nerve-sparing surgical techniques, and participating to the understanding of neurogenic female sexual dysfunction.
Impact of Sacral Neuromodulation on Female Sexual Function and His Correlation with Clinical Outcome and Quality of Life Indexes: A Monocentric Experience
Authors: Signorello Diego , Seitz Carl Christian , Berner Lucas , Trenti Emanuela , Martini Thomas , Galantini Andrea , Lusuardi Lukas , Lodde Michele , Pycha Armin 
Published: January 2011

ABSTRACT

Introduction
Lower urinary tract symptoms (LUTS) have a profound impact on physical, social, and sexual well-being. Sacral neuromodulation (SNM) may have a positive effect on sexuality, though few studies have so far evaluated its impact on female sexual function.

Aim
To prospectively assess changes in sexual function, clinical outcome and quality of life after SNM in female patients with overactive bladder (OAB) and their possible correlation with improvement in urinary symptoms and quality of life indexes.

Main Outcome Measures
Correlations between differences in Female Sexual Function Index (FSFI) scores and in clinical outcome and correlations between differences in FSFI, SF36, and IQoL scores were evaluated by Spearman’s coefficient. Comparison between preoperative, midterm follow-up (MFU), and last follow-up (FFU) visits were performed by generalized linear model (GLM) for repeated measurements.

Methods
Between May 2003 and December 2008, 30 consecutive female patients (median age 53 years, range 35–79) with OAB underwent the two-stage procedure of SNM. Only 16 (53%) patients were considered eligible; these completed a bladder diary, the FSFI, the Status of Health questionnaire (SF36) and the Incontinence Quality of Life Index (IQoL) before implantation and on follow-up examinations.

Results
The results were analyzed before implantation, on MFU (median MFU 22.5 months) and on FFU (median FFU period 36.3 months). Regarding sexuality, the mean improvement in the total FSFI score was 27.9% on MFU and 29.3% on FFU. Only four patients (25%) showed a &gt;50% improvement in global FSFI score on MFU, and 3 (25%) on FFU. A significant correlation was found between clinical improvement and improvement in sexual function. No significant correlation was found between differences in FSFI and quality of life indexes (IQoL and SF36).

Conclusion
Our results demonstrate that improvement in the quality of sexual function in female patients with OAB correlates with improvement in urinary symptoms.
Vardenafil and Resveratrol Synergistically Enhance the Nitric Oxide/Cyclic Guanosine Monophosphate Pathway in Corpus Cavernosal Smooth Muscle Cells and its Therapeutic Potential for Erectile Dysfunction in the Streptozotocin-Induced Diabetic Rat: Preliminary Findings
Authors: Fukuhara Shinichiro , Tsujimura Akira , Okuda Hidenobu , Yamamoto Keisuke , Takao Tetsuya , Miyagawa Yasushi , Nonomura Norio , Okuyama Akihiko 
Published: January 2011

ABSTRACTIntroductionPhosphodiesterase type 5 (PDE5) inhibitors are very effective agents for erectile dysfunction; however, specific patient populations are hard to treat. The efficacy of PDE5 inhibitors is limited because a minimum amount of nitric oxide (NO) is necessary. Resveratrol, a plant polyphenol, is reported to activate endothelial NO synthase (eNOS) through activation of sirtuin 1. We previously reported that human corpus cavernosal smooth muscle cells (CCSMCs) express eNOS and synthesize cyclic guanosine monophosphate (cGMP) via the NO/cGMP pathway.AimTo investigate the ability of resveratrol and/or vardenafil to increase cGMP in an in vitro model using CCSMCs and to improve erectile function in an in vivo rat model of streptozotocin (STZ)-induced diabetes.MethodsCCSMCs were treated with resveratrol and/or vardenafil. Twenty male Sprague-Dawley rats were randomly divided into five groups (N = 4 in each group): age-matched controls, diabetic controls, and diabetic rats treated with resveratrol, vardenafil, or both in combination for the last 4 weeks of an 8-week period of diabetes induction.Main Outcome MeasuresIntracellular cGMP measurement, intracovernous pressure (ICP)/mean arterial pressure (MAP) ratio, and smooth muscle/collagen ratio.ResultsIntracellular cGMP level was elevated by resveratrol treatment in CCSMCs. The combination treatment of resveratrol and vardenafil had a synergistic effect. Diabetic rats showed impairment of erectile function. Treatment with either resveratrol or vardenafil improved ICP/MAP ratio, and combination therapy with resveratrol and vardenafil had a synergistic effect in improvement of ICP/MAP.ConclusionsTreatment with either resveratrol or vardenafil elevated cGMP level in CCSMCs and improved erectile function in STZ-induced diabetic rats. Furthermore, a synergistic effect was observed in vitro and in vivo. Resveratrol or combination therapy of resveratrol and vardenafil can improve erectile function in which NO release is impaired, although further study is needed to confirm the results.
A Phase IV Prospective Evaluation of the Safety and Efficacy of Extended Release Testosterone Pellets for the Treatment of Male Hypogonadism
Authors: Kaminetsky Jed C. , Moclair Betsy , Hemani Micah , Sand Matthew 
Published: January 2011

ABSTRACT

Introduction
Men with hypogonadism exhibit decreased serum testosterone levels and may experience a constellation of clinical symptoms, including decrease in muscle mass, loss of sexual desire, impotence, and infertility. While previous studies have shown that implantation of extended release testosterone pellets can provide therapeutic levels of testosterone over several months, additional data are needed to establish this approach as the standard of care for male hypogonadism.

Aim
To evaluate the safety and efficacy of testosterone pellets over 6 months as a treatment for male hypogonadism in a clinical practice setting.

Methods
A phase IV, single center, open-label study designed to assess the safety and efficacy of subcutaneous insertion of 8 to 12 testosterone 75 mg pellets (450 mg to 900 mg), during a single implantation procedure in hypogonadal men. Subjects who successfully completed the protocol were allowed to enroll in an extension study that included another implantation and 6 months of follow-up.

Main Outcome Measures
Safety was determined by investigator-reported adverse events, changes in vital signs, physical exam findings, and laboratory tests. Efficacy was based on serum laboratory tests, physical exams, implantation site evaluations, and vital signs. Secondary objectives were to assess patient preference for testosterone pellets and to maintain optimal total testosterone.

Results
Mean testosterone significantly increased and luteinizing hormone (LH) levels significantly decreased from pre-implantation values at weeks 1, 4, and 12, and had returned to pre-implantation levels by week 24. Prostate-specific antigen levels remained unchanged for the duration of the study. Improvements in several symptoms of hypogonadism were determined with multiple questionnaires. Implanted testosterone pellets were generally well tolerated.

Conclusion
Implanted testosterone pellets can normalize testosterone and LH levels and improve symptoms for at least 3 months and up to 6 months in men with hypogonadism, and should be considered as a therapeutic option for hypogonadal men.
Impact of Cannabis Use on Male Sexual Health
Authors: Shamloul Rany , Bella Anthony J. 
Published: January 2011

ABSTRACT

Introduction
Cannabis (marijuana) is the most widely used illicit drug globally. Given the prevalence of nonprescription illicit drug abuse, there is a growing interest in the study of its potential effects on male sexual health. In this review, we discuss the effects of cannabis on male sexual health.

Objective
In this review, we discuss the effects of cannabis on male sexual health.

Methods and Main Outcome Measure
Critical review of scientific literature examining the impact of cannabis use on male sexual health.

Results
Studies examining the effects of cannabis use on male sexual function have been limited in both quality and quantity. Most results of these studies are conflicting and contradictory. While some did outline the beneficial effects of cannabis in enhancing erectile function, others did not. However, recent animal and in vitro studies have identified potential links between cannabis and sexual health. It appears that cannabis may actually have peripheral antagonizing effects on erectile function by stimulating specific receptors in the cavernous tissue.

Conclusions
Given the prevalence of cannabis use, and the potential relationships between use and the development of potentially hazardous effects on male sexual function, we encourage renewed use of research resources to determine in-depth mechanistic knowledge, and new clinically oriented studies examining the effect of cannabis on male sexual function.