bluuebunny/crossref_metadata_2025_split huggingface dataset:
Clinical trial considerations on male contraception and collection of pregnancy information from female partner: update
Authors: Banholzer Maria Longauer , Wandel Christoph , Barrow Paul , Mannino Marie , Schmitt Georg , Guérard Melanie , Müller Lutz , Greig Gerard , Amemiya Kenjie , Peck Richard , Singer Thomas , Doessegger Lucette 
Published: July 2016

AbstractBackgroundThis is an update to our 2012 publication on clinical trial considerations on male contraception and collection of pregnancy information from female partner, after critical review of recent (draft) guidances released by the International Council for Harmonisation [ICH] the Clinical Trial Facilitation Group [CTFG] and the US Food & Drug Administration [FDA].MethodsRelevant aspects of the new guidance documents are discussed in the context of male contraception and pregnancy reporting from female partner in clinical trials and the approach is updated accordingly.ResultsGenotoxicity The concept of a threshold is introduced using acceptable daily intake/permissible daily exposure to define genotoxicity requirements, hence highly effective contraception in order to avoid conception. The duration for highly effective contraception has been extended from 74 to 90 days from the end of relevant systemic exposure. Teratogenicity Pharmacokinetic considerations to estimate safety margins have been contextualized with regard to over‐ and underestimation of the risk of teratogenicity transmitted by a vaginal dose. The duration of male contraception after the last dose takes into account the end of relevant systemic exposure if measured, or a default period of five half‐lives after last dose for small molecules and two half‐lives for immunoglobulins (mAbs). Measures to prevent exposure of the conceptus via a vaginal dose apply to reproductively competent or vasectomized men, unless measurements fail to detect the compound in seminal fluid.ConclusionCritical review of new guidance documents provides a comparison across approaches and resulted in an update of our previous publication. Separate algorithms for small molecules and monoclonal antibodies are proposed to guide the recommendations for contraception for male trial participants and pregnancy reporting from female partners. No male contraception is required if the dose is below a defined threshold for genotoxic concern applicable to small molecules. For men treated with teratogenic mAbs, condom use to prevent exposure of a potentially pregnant partner is unlikely to be recommended because of the minimal female exposure anticipated following a vaginal dose. The proposed safety margins for teratogenicity may evolve with further knowledge.
Recovery of Lower Cranial Nerve Function after Surgery for Medullary Brainstem Tumors
Authors: Jallo George I. , Shiminski-Maher Tania , Velazquez Linda , Abbott Rick , Wisoff Jeff , Epstein Fred 
Published: July 2016

Abstract

OBJECTIVE:
Although optimal treatment for intrinsic focal tumors of the medulla remains controversial, many surgeons advocate radical surgery for patients with these tumors. Postoperative surgical morbidity may include loss of lower cranial nerve function and significant motor deficits. Recovery of lower cranial nerve dysfunction after radical surgery has not been reported previously.

METHODS:
Forty-one children and adolescents with tumors involving the medulla underwent operations between 1986 and 1997. Nineteen (46%) of these patients experienced loss of lower cranial nerve function requiring tracheostomy, ventilator support, and feeding gastrostomy. A retrospective analysis of this patient population and the time to cranial nerve recovery was undertaken.

RESULTS:
Thirteen (68%) of the 19 patients with loss of lower cranial nerve function had full recovery of lower cranial nerve function. Two patients (11%) have had significant improvement in their lower cranial nerve function, and four patients (21%) have remained without lower cranial nerve function.

CONCLUSION:
Lower cranial dysfunction is common after surgery for intrinsic medullary tumors. However, the majority of patients who require tracheostomy or gastrostomy tubes will recover cranial nerve function.
Decompressive Hemicraniectomy for Poor-grade Aneurysmal Subarachnoid Hemorrhage Patients with Associated Intracerebral Hemorrhage: Clinical Outcome and Quality of Life Assessment
Authors: D'Ambrosio Anthony L. , Sughrue Michael E. , Yorgason Joshua G. , Mocco J D. , Kreiter Kurt T. , Mayer Stephan A. , McKhann Guy M. , Connolly E Sander 
Published: July 2016

Abstract

OBJECTIVE:
Decompressive hemicraniectomy has been proposed as a potential treatment strategy in patients with poor-grade aneurysmal subarachnoid hemorrhage presenting with focal intracerebral hemorrhage causing significant mass effect. Although hemicraniectomy improves overall survival rates, the long-term quality of life (QoL) for survivors in this patient population has not been reported.

METHODS:
Using adjudicated outcome assessments, we compare long-term clinical outcomes and QoL between a group of patients with poor-grade aneurysmal subarachnoid hemorrhage receiving decompressive hemicraniectomy (n = 12) and a control group of similar patients managed more conservatively (n = 10).

RESULTS:
Patients receiving decompressive hemicraniectomy experienced a statistically insignificant decrease in short-term mortality compared with controls (25 versus 42%); however, long-term QoL in hemicraniectomy survivors was generally poor. Furthermore, hemicraniectomy patients did not experience an increase in mean quality-adjusted life years over control patients (2.31 versus 2.22 yr).

CONCLUSION:
Decompressive hemicraniectomy prolongs short-term survival in patients with poor-grade aneurysmal subarachnoid hemorrhage with associated intracerebral hemorrhage; however, this trend is not statistically significant, and the overall QoL experienced by survivors is poor. Decompressive hemicraniectomy may be indicated if performed early in a select subset of patients. On the basis of our preliminary data, large prospective studies to investigate this issue further may not be warranted.
Pituitary Apoplexy
Authors: Semple Patrick L. , Webb Michael K. , de Villiers Jacques C. , Laws Edward R. 
Published: July 2016

Abstract

OBJECTIVE:
Pituitary apoplexy is a rare yet potentially fatal disease. We reviewed the combined experience of the University of Virginia in Charlottesville, VA, and Groote Schuur Hospital, University of Cape Town, South Africa, with 62 cases of pituitary apoplexy.

METHODS:
An Internet web site with a database was constructed, and the records of 62 patients were entered into the database from both institutions and then systematically analyzed.

RESULTS:
The average age of patients was 51.1 years; 60% were male, and the average length of follow-up was 55 months. The average time of presentation was 14.2 days after the ictus, and 81% had no previous history of pituitary tumor. Headache was the most common presenting symptom (87%). Diminished visual acuity was found in 56% of patients, bitemporal hemianopia in 34%, ocular palsies in 45%, and diminished level of consciousness in 13%. Seventy-three percent of the patients had laboratory evidence of hypopituitarism, and 8% had diabetes insipidus. Fifty-eight patients underwent surgery, 3 were treated conservatively, and 1 died before intervention. Histological examination revealed hemorrhagic infarction in 47%, simple infarction in 40%, and frank hemorrhage in 8%. Seventy-nine percent had a good outcome, although 83% required subsequent hormonal replacement therapy.

CONCLUSION:
Pituitary apoplexy is often misdiagnosed because the majority of patients have undetected pituitary adenomas, and the presentation is often mistaken for subarachnoid hemorrhage. Most cases of pituitary apoplexy occur spontaneously, although precipitating factors have been suggested. Magnetic resonance imaging is the imaging modality of choice. Treatment includes high-dose corticosteroid administration and surgery. Transsphenoidal surgery is indicated in patients with diminished levels of consciousness, hypothalamic dysfunction, and visual deterioration. Conservative management for patients with isolated cranial nerve palsies has been advocated but remains controversial.
Diffusion Tensor Imaging with Three-dimensional Fiber Tractography of Traumatic Axonal Shearing Injury: An Imaging Correlate for the Posterior Callosal “Disconnection” Syndrome: Case Report
Authors: Le Tuong H. , Mukherjee Pratik , Henry Roland G. , Berman Jeffrey I. , Ware Marcus , Manley Geoffrey T. 
Published: July 2016

Abstract

OBJECTIVE:
To demonstrate that magnetic resonance diffusion tensor imaging (DTI) with three-dimensional (3-D) fiber tractography can visualize traumatic axonal shearing injury that results in posterior callosal disconnection syndrome.

METHODS:
A 22-year-old man underwent serial magnetic resonance imaging 3 days and 12 weeks after blunt head injury. The magnetic resonance images included whole-brain DTI acquired with a single-shot spin echo echoplanar sequence. 3-D DTI fiber tractography of the splenium of the corpus callosum was performed. Quantitative DTI parameters, including apparent diffusion coefficient and fractional anisotropy, from the site of splenial injury were compared with those of a normal adult male volunteer.

RESULTS:
Conventional magnetic resonance images revealed findings of diffuse axonal injury, including a lesion at the midline of the splenium of the corpus callosum. DTI performed 3 days posttrauma revealed that the splenial lesion had reduced apparent diffusion coefficient and fractional anisotropy, reflecting a large decrease in the magnitude of diffusion parallel to the white matter fibers, which had partially recovered as revealed by follow-up DTI 12 weeks postinjury. 3-D tractography revealed an interruption of the white matter fibers in the posteroinferior aspect of the splenium that correlated with the patient's left hemialexia, a functional deficit caused by disconnection of the right visual cortex from the language centers of the dominant left hemisphere.

CONCLUSION:
DTI with 3-D fiber tractography can visualize acute axonal shearing injury, which may have prognostic value for the cognitive and neurological sequelae of traumatic brain injury.
Simple Decompression versus Anterior Submuscular Transposition of the Ulnar Nerve in Severe Cubital Tunnel Syndrome: A Prospective Randomized Study
Authors: Gervasio Olga , Gambardella Giuseppe , Zaccone Claudio , Branca Damiano 
Published: July 2016

AbstractOBJECTIVE:The authors report the results of a clinical series of selected patients with severe cubital tunnel syndrome. The degree of ulnar nerve compression was evaluated by use of a grading system that includes measurements of motor and sensitive function. The submuscular transposition with flexor-pronator mass Z lengthening was compared with simple decompression through a prospective randomized study.METHODS:From February 1998 to June 2003, 70 patients with severe cubital tunnel syndrome were included in this study: 35 patients were submitted to simple decompression (Group A), and 35 patients were treated by anterior deep submuscular transposition (Group B). The preoperative status was determined by use of Dellon's classification. The selected patients had Dellon's Grade 3 (severe syndrome). The mean follow-up period after surgery was 47 months for Group A and 46.94 months for Group B.RESULTS:Postoperative clinical and electrophysiological outcomes were assessed 6 months after surgery in all 70 patients. According to the Bishop scoring system, 19 patients (54.3%) of Group A were clinically graded as excellent, 9 (25.7%) were graded as good, and 7 (20%) were graded as fair; in Group B, 18 patients (51.43%) were graded as excellent, 11 (31.43%) as good, and 6 (17.14%) as fair. Neither severe complications nor recurrences were observed in the two groups.CONCLUSION:No statistically significant difference was found between the two groups with regard to the clinical or the electrophysiological outcome. The surgical treatment gains in Group A and B were 80% and 82.86%, respectively (good to excellent results).
Isolated Central Nervous System Hemophagocytic Lymphohistiocytosis: Case Report
Authors: Shinoda Jun , Murase Satoru , Takenaka Katsunobu , Sakai Noboru 
Published: July 2016

Abstract

OBJECTIVE AND IMPORTANCE:
The first case of histologically proven hemophagocytic lymphohistiocytosis (HLH) isolated to the central nervous system (CNS) is reported. HLH affecting the CNS mimics several neurological disorders and may be misdiagnosed. The diagnostic and therapeutic problems of this disease are discussed.

CLINICAL PRESENTATION:
We report a case of a 5-year-old girl with a 2-month history of right hemiparesis. The initial magnetic resonance imaging scan mimicked the appearance of malignant glioma or cerebral infarction. By use of neuroimaging alone, it was extremely difficult to reach an appropriate diagnosis.

INTERVENTION:
Pathological examination of a surgical specimen of the lesion revealed histological characteristics typical of HLH. Because of the absence of both physical and blood chemical findings of systemic HLH, the patient was diagnosed as having HLH isolated in the CNS without systemic HLH. Radiotherapy with corticosteroid administration led to complete resolution of the CNS lesions, but the duration of remission was only 3 months. The patient died secondary to refractory progression of the CNS lesion.

CONCLUSION:
Radiotherapy with corticosteroid administration led to a complete resolution of the lesions, although for only a transitory remission. Although HLH is extremely rare, the existence of this disease isolated in the CNS should be documented, and further case accumulation and therapeutic investigations are needed to clarify the pathophysiological characteristics of this disease.
Pilomyxoid Astrocytoma of the Spinal Cord: Report of Three Cases
Authors: Komotar Ricardo J. , Carson Benjamin S. , Rao Chandrankant , Chaffee Sara , Goldthwaite Patricia T. , Tihan Tarik 
Published: July 2016

Abstract

OBJECTIVE AND IMPORTANCE:
Pilomyxoid astrocytoma (PMA) is a recently described, rare, circumscribed glioma similar to pilocytic astrocytoma. Despite its circumscribed nature, PMA implies a worse overall outcome than typical pilocytic astrocytoma. All PMAs reported to date involved the hypothalamic/chiasmatic region. Since these original reports, we have encountered three tumors in the spinal cord with histological features identical to those of PMA.

CLINICAL PRESENTATION:
We report three male pediatric patients. The first patient presented at age 6 with back pain and constipation. The second patient presented at age 8 with back pain and a bout of urinary incontinence. The third patient, a neonate, presented with respiratory failure and hypotonia.

INTERVENTION:
The first patient's cervical and thoracic neoplasm was treated with subtotal resection and multiple laminectomies and spinal fusion for recurrence. The second patient underwent gross total resection of his thoracic neoplasm. The neonate underwent laminectomy and biopsy of his holocord tumor.

CONCLUSION:
PMAs typically occur in the hypothalamic region and within the first 4 years of life. Tumors with identical histological features are being recognized outside this typical clinical setting. The cases presented in this report suggest that PMA can occur at a later age and can involve the spinal cord. We believe that increased recognition of these circumscribed gliomas will help to elucidate their nature and lead to better management decisions.
Vajazzled!!! Pursuits for the hirsute
Authors: Turney Jo 
Published: July 2016

Abstract
Pubic hair has long been a contentious subject for women, and, in relation to constructions of psychoanalytical Otherness. Indeed, from Freud’s assertion that female pubic hair conceals a ‘lack’, natural genital hair growth has been a site of simultaneous shame and control, an intimate feature requiring habitual clipping, preening and restraint. Feminists have aligned this bodily restraint with social constraint, as men rarely pluck, shave or dye their pubic hair, and control over such ‘hidden’ areas heightens and perpetuates women’s ‘shame’. Consequently, as Germaine Greer acknowledges, stereotypical women pluck, shave and wax their bikini lines, and somewhat ironically, unfettered pubic hair by the 1980s had become a sign of the unfeminine feminist. In a post-feminist era, pubic hair, or the lack of it, remains a site of discourse. From fashions in waxing (the Brazilian and the Hollywood) to shaping and dyeing, pubic hair has become commodified, a beauty essential, removed aggressively from its political roots. This article is concerned with vajazzling, the removal of pubic hair and its replacement with diamante sparkles and other ‘jewellery’. Focusing on the celebration of excess body modification and the quest for ‘beauty’ via luxury consumption exemplified in this series, this article questions and investigates the historical significance of the lack of pubic hair and its beaded replacement in contemporary body projects.
Dressing modern identity: Victorian style re-imagined in the Angelica Garnett Gift
Authors: Wolstenholme Zoe 
Published: July 2016

Abstract
This article discusses recent finds in the Angelica Garnett Gift of 8000 previously unseen works of art by Bloomsbury artists Vanessa Bell and Duncan Grant, donated to The Charleston Trust in 2008. The Charleston Trust cares for Charleston House, the Sussex home of Bell and Grant, and the collection of their and their contemporaries’ artworks. The Angelica Garnett Gift has emphasized the overlooked importance of dress to the work and lives of Bell and Grant and calls for more attention on the sartorials of Bloomsbury. This article aims to spark discussion in this understudied field, focusing on two examples found in the Gift, which reinterpret and reclaim the Victorian styles of the top hat and the fan to express possibilities of modern identity. These works interrogate how dress can negotiate experiences of both gender and modernity while also revealing understudied artistic and design processes, for Duncan Grant with the Omega Workshops and Vanessa Bell later in life. The style of the Bloomsbury Group continues to inspire designers today who find their modernist dress equally suitable to express the contemporary moment.
Descrição arquivística e catálogo do arquivo do professor doutor Manuel dos Reis (1919-1986)
Authors: Silva Ana Margarida Dias da 
Published: July 2016

O arquivo do professor doutor Manuel dos Reis, salvaguardado no Arquivo da Universidade de Coimbra desde outubro de 2013, engloba informação/documentação maioritariamente manuscrita, produzida no âmbito da sua atividade enquanto investigador de Matemática, compreendendo estudos e notas científicas de matemática, de astronomia, de probabilidade, de relatividade geral, de mecânica celeste e relacional, de análise superior, etc. O presente catálogo pretende ser um contributo para um melhor conhecimento da investigação científica realizada por Manuel dos Reis entre 1919 e 1986. http://dx.doi.org/10.14195/2182-7974_29_3
BUTYLTIN RESIDUES IN SEDIMENTS FROM THE EASTERN GULF OF THAILAND
Authors: Praditsup Nichaya , Wattayakorn Gullaya 
Published: July 2016

Concentrations of monobutyltin (MBT), dibutyltin (DBT) and tributyltin (TBT) compounds were analyzedÂ in surface sediment samples collected from twelve stations along the Eastern Gulf of Thailand. The total butyltinÂ (âˆ‘BTs) concentrations ranged between <1 and 109.7 ng gÂ (dry weight). The overall concentration ranges foundÂ in the sediments were from <1 to 79.81 ng g-1Â for MBT, from <1 to 9.5 ng gÂ -1Â for DBT, and from <1 to 29.8 ng g-1 for TBT, on a dry weight basis. MBT generally prevailed in most of the samples, suggesting the occurrence of old inputs of butyltin compounds in the area. Butyltin compounds were also measured in Nassarius sp., where âˆ‘BTs concentrations were found to range between <1 and 238 ng g-1 (wet weight). The level of butyltin compounds in gastropod tissue samples tended to be related to that of the sediments and percentage of imposex incidence.
BIOACCUMULATION OF CADMIUM (CD) BY WHITE SHRIMP PENAEUS MERGUIENSIS AT DIFFERENT SALINITY IN KEDUNGMALANG ESTUARY, JEPARA (CENTRAL JAVA)
Authors: Manullang Corry Yanti , Hutabarat Johannes , Widowati Ita 
Published: July 2016

Estuarine of Kedungmalang has salinity variability and is assumed to bepolluted by cadmium (Cd) derived from human activities around Kedung region. In this study, bioaccumulation of Cd by white shrimp PenaeusÂ merguienis in relation with salinity difference was determined. Sampling was conducted at four stations : estuary (15â€° and 25â€° of salinity) and husbandry area (15â€° and 25â€° of salinity). Data on in situ water quality parametersÂ was obtained at each station. Absorption Atomic Spectrometer was used to measure Cd concentration. The water quality of parameters and the concentrations of Cd in the shrimp were compared with quality standards and weeklyÂ consumption limit of white shrimps is also suggested. The Cd concentrations on the white shrimp was found the highest concentration of 0.669 Î¼g.g-1 . The limit comsumption of the white shrimp of Estuarine of Kedungmalang,suggested by the resut of this study, is about 523-1537 grams per week.
DISTRIBUTION OF METALS IN CISANGGARUNG ESTUARY SEDIMENT, WEST JAVA, INDONESIA
Authors: Budiyanto Fitri , Lestari - 
Published: July 2016

Volcanic activities have inï¬‚ uenced the Cisanggarung estuary in western Cirebon Regency, altering metalÂ concentrations in the bottom sediment. Observation of metal content in the ocean there was carried out in AugustÂ 2009. Sediment samples were collected at 16 stations along the Cisanggarung coastline. The aim of this work wasÂ to determine the spatial distribution of Cd, Cu, Pb and Zn in the sediment of the Cisanggarung estuary. SedimentÂ was destructed using 3 acids: nitric acid, chloride acid and peroxide acid, which was then analyzed by Flame AtomicÂ Absorption Spectrophotometry based on the US EPA 3050b method. The highest concentrations of Cd, Cu, Pb andÂ Zn in the sediment were 0.73 mg/kg dry weight, 31.4 mg/kg dry weight, 23.9 mg/kg dry weight and 143 mg/kg dryÂ weight, respectively. The metals in the sediment had accumulated near the shoreline, up to ï¬ ve kilometers awayÂ from the river mouth, indicating that terrestrial area and sediment fractions inï¬‚ uenced their distribution.
THE CONDITION OF CORAL REEFS IN WEST BANGKA WATER
Authors: Siringoringo Rikoh Manogar , Hadi Tri Aryono 
Published: July 2016

Bangka Island is well known as the worldâ€™s largest tin producer. The inland and offshore tin mining hasÂ profound effects on the coastal environment, resulting in the high sedimentation in the water. Many corals sufferedÂ physiological damage due to low light intensity. The distribution of stony corals and the status of coral reefs wasÂ surveyed at 6 sites in West Bangka waters in October 2012. A total of 72 species of corals belonging to 33 generaÂ and 12 families were found, and 4 species were distributed at all research sites. The live coral coverage was 36% on average and was categorized as being in fair condition. The coverage was 0% at Kamboja Island where the coralsÂ were the most affected by tin mining. The sediment flowed out from tin mining, blocked the light, and settled onÂ the coralsâ€™ surface. Consequently, many corals were buried and the live corals decreased. It is obviously necessaryÂ to reduce and control the tin mining.