Real-World Effectiveness of Calcitonin Gene-Related Peptide-Binding Monoclonal Antibodies for Migraine Prevention: A Systematic Review.

Background: Migraine is a neurological disease with a high incidence. The new anti-calcitonin gene-related peptide monoclonal antibodies (anti-CGRP mAbs) have demonstrated effectiveness in preventing episodic and chronic migraine.

Objective: To collect evidence of the real-world effectiveness of anti-CGRP mAbs by assessing outcomes such as reduction in monthly migraine days (MMDs), reduction in monthly headache days (MHDs), and percentage of patients having a 50% reduction in MMDs.

Is there any place for novel agents in treating biliary tract cancer?

Biliary tract cancer is an uncommon cancer in developed countries. In localized stages, surgery is the cornerstone of treatment with curative purpose. Conversely in advanced stages, chemotherapy with platinum-gemcitabine combination is the standard of care.

Continuous-infusion and outpatient setting: A chance for patients, a challenge for hospital pharmacists.

The use of continuous-infusion in outpatient setting could be widely used in oncology and haematology care. Many times the lack of data stability about single drug or admixture of drugs, together with patient education and safety, make difficult the transition from inpatient to outpatient setting. Nowadays, this is a big challenge for hospital pharmacists, who must take into consideration the critical issues related to chemical and physical stability, besides microbiological one, in order to ensure high quality preparations and guarantee the safety and quality of care, to protect patients and their health.

A systematic review of salvage therapies in refractory metastatic colorectal cancer.

Purpose: Established that the only approved agents in previously treated metastatic colorectal cancer (CRC) are trifluoridine/tipiracil and regorafenib, we conducted a systematic review of all the published phase 2-3 trials, with the scope to evaluate the benefit of any later-line regimens in refractory metastatic CRC.

Methods: Phase 2-3 studies that enrolled patients with stage IV disease receiving salvage therapies for refractory CRC were identified using electronic databases (Pubmed, EMBASE, and Cochrane Library). Clinical outcomes were pooled using a point estimates for the weighted values of median overall survival (OS), progression-free survival (PFS), response rate (ORR), stable disease rate (SD), and 6-month and 1-year OS.

Pharmacological issues concerning olaparib capsule and tablet formulations in treating ovarian cancer: Are they really the same drug?

Olaparib is a first-in-class PARP inhibitor that has demonstrated efficacy as maintenance therapy in patients with ovarian cancer. It has been approved as a capsule formulation and after the publication of data from SOLO2 study became available also as tablet formulation. Due to different pharmacokinetic properties, these different formulations cannot be considered bioequivalent nor interchangeable.

Developmental changes in aural acoustic admittance measurements.

Tympanometry is a clinical measurement routinely included in the assessment of middle ear function. Despite its widespread use, however, fundamental questions remain regarding the need for age-dependent normative data. This study examines normal developmental changes associated with four tympanometric measurements: (1) ear canal volume, (2) peak compensated acoustic admittance, (3) tympanometric width, and (4) tympanometric peak pressure.

Unmasked thresholds and minimum masking in infants and adults: separating sensory from nonsensory contributions to infant-adult differences in behavioral thresholds.

Objective: The purposes were to determine the degree to which infant unmasked thresholds differed from those of adults, to determine the effect of signal frequency on those differences, and to determine whether there is a difference in minimum effective masking as a function of age and frequency. The data were applied to a model to address the question of the origin (sensory versus nonsensory) of infant-adult differences in behavioral unmasked thresholds.

Design: Infant behavioral thresholds in quiet and in noise for pure tones of 0.

Topical ofloxacin versus systemic amoxicillin/clavulanate in purulent otorrhea in children with tympanostomy tubes.

Acute otitis media (AOM) in children with tympanostomy tubes in place typically presents with otorrhea (draining ear). Because therapy is not standardized, various topical and systemic antibiotics of unproven efficacy and safety have been used in this indication. This study compared the safety and efficacy of ofloxacin otic solution, 0.

Age-related hearing loss, vitamin B-12, and folate in elderly women.

Background: Hearing impairment is 1 of the 4 most prevalent chronic conditions in the elderly. However, the biological basis of age-related hearing loss is unknown.

Objective: The objective was to test the hypothesis that age-related hearing loss may be associated with poor vitamin B-12 and folate status.

A role for otoacoustic emissions in screening for hearing impairment and middle ear disorders in school-age children.

Objective: The primary purpose of this study was to investigate the potential role of transient-evoked otoacoustic emissions (TEOAEs) for screening for hearing impairment and middle ear disorders in school-age children. Because TEOAEs are present in ears with normal cochlear and middle ear function and typically are absent or reduced in ears with cochlear and/or middle ear disorders of even mild degree, TEOAE screening could serve as a first-stage screening to separate from the general population of school-age children those at greater risk for hearing impairment and/or middle ear disorder. There were two secondary objectives.

Comparison of acoustic immittance measures obtained with different commercial instruments.

Three acoustic admittance measurements (tympanometric peak pressure, peak compensated static acoustic admittance, and tympanometric width) were compared across seven commercially available acoustic immittance systems. Forty-nine adult subjects (45 females and 4 males), 16 to 50 years of age (mean = 27.7 years), with normal middle ear function participated in this investigation.

Estimating the contribution of non-sensory factors to infant-adult differences in behavioral thresholds.

Estimates of behavioral thresholds of infants are elevated relative to those of adults. Explanations for the differences include auditory sensory factors and non-sensory factors, but no direct estimates of the relative contributions of these two factors have been made. In this investigation, thresholds in quiet and in increasing levels of a masking noise for a 1 kHz tone, in infants 8 to 11 months old and in adults, were determined.

Identification of middle ear effusion by aural acoustic admittance and otoscopy.

The ability of aural acoustic immittance measures and validated pneumatic otoscopy to identify middle ear effusion (MEE) was determined for a group of children with chronic or recurrent otitis media. The measures were made immediately prior to surgery for placement of tympanostomy tubes, with the validating diagnosis of MEE made by the surgeons. Aural acoustic admittance measures were made by a certified and licensed clinical audiologist using an instrument that meets current standards and otoscopic examinations were made by a nurse practitioner validated for use of otoscopy in the identification of MEE.

Towards the validation of aural acoustic immittance measures for diagnosis of middle ear effusion in children.

Acoustic admittance testing was done on the ears of two groups of children. The first group was comprised of children undergoing myringotomy and tube surgery for treatment of chronic or recurrent otitis media, and the second group was comprised of hospital outpatients who were unscreened with respect to a history of middle ear disease and who were more representative of children in the general population. The admittance measures were then analyzed with respect to middle ear status (effusion versus no effusion) as determined by the surgeon (surgery group) and by validated otoscopy (outpatient group).

Efficacy of antimicrobial prophylaxis and of tympanostomy tube insertion for prevention of recurrent acute otitis media: results of a randomized clinical trial.

To determine the efficacy of amoxicillin prophylaxis and of tympanostomy tube insertion in preventing recurrences of acute otitis media, we randomized 264 children 7 to 35 months of age who had a history of recurrent otitis media but were free of middle ear effusion to receive either amoxicillin prophylaxis, bilateral tympanostomy tube insertion or placebo. The average rate of new episodes per child year of either acute otitis media or otorrhea was 0.60 in the amoxicillin group, 1.

Efficacy of myringotomy with and without tympanostomy tubes for chronic otitis media with effusion.

In a previous trial involving 109 children with chronic otitis media with effusion of at least a 2 months' duration that had been unresponsive to medical treatment, we compared the efficacy of myringotomy with tube insertion, myringotomy alone and no surgical intervention with regard to time with middle ear effusion, hearing status and other indices over a 3-year period. Because interpretation of the results was rendered difficult by certain complexities of study design, the present trial with a revised protocol was carried out in an additional group of 111 children. As in the previous trial, myringotomy with tube insertion resulted in less time with effusion and better hearing than did either myringotomy alone or no surgery.

Comparative efficacy of erythromycin-sulfisoxazole, cefaclor, amoxicillin or placebo for otitis media with effusion in children.

We randomly assigned children with otitis media with effusion to receive either erythromycin-sulfisoxazole, cefaclor, amoxicillin or placebo for a 2-week period, primarily to determine whether either erythromycin-sulfisoxazole or cefaclor would have greater short term efficacy than that found previously for amoxicillin, and secondarily to supplement earlier data on outcomes in placebo-treated subjects. Interim analyses showed no statistically significant (P less than 0.05) differences between the three antimicrobial treatment groups in the primary outcome measures, i.

Reliability and validity of infant speech-sound discrimination-in-noise thresholds.

Infants were tested on a speech-sound discrimination-in-noise task using the visual reinforcement infant speech discrimination (VRISD) procedure with an adaptive (up-down) threshold protocol. An adult control group was tested using the same stimuli and apparatus. The speech sounds were synthetic magnitude of ba and magnitude of ga.

Ten years of extracorporeal membrane oxygenation: neurodevelopmental outcome.

Cf the 87 survivors of extracorporeal membrane oxygenation over a 10-year period, 67 participated in a follow-up study which included neurologic examination (n = 67), cognitive testing (n = 67), and audiologic assessment (n = 33). Matched control subjects for those older than 5 years were also evaluated. Outcome was defined as normal for cognitive scores greater than or equal to 85 and normal neurologic examination results, suspect for cognitive scores 70 through 84 or nonfocal neurologic findings such as hypertonia/hypotonia, and abnormal for cognitive scores less than 70 or abnormal neurologic examination results.

Audiological and medical considerations for children with cochlear implants.

Recent advancements in technology have resulted in the development of implantable devices--cochlear implants--designed to maximize the sensation of hearing in the hearing-impaired population. For children who meet the numerous preselection criteria, the cochlear implant can be effective and beneficial. The implants must be inserted surgically, which involves placing an electrode array in the cochlea and attaching the receiver/stimulator to the skull.

Infant-adult differences in unmasked thresholds for the discrimination of consonant-vowel syllable pairs.

Speech sound discrimination thresholds were obtained for two speech sound contrasts (/ba/ vs. /da/ and /ba/ vs. /ga/) for infant and adult subjects.

Infant speech-sound discrimination in noise.

The effects of noise on 7- to 11-month-old infants' speech-sound discrimination (/ba/vs/ga/) were determined using a conditioned head-turn procedure. Variation in performance as a function of signal-to-noise ratio (S/N) was estimated by testing each infant at four S/N's (-8, 0, 8, and 16 dB). Adults were tested for comparison at four S/N's (-12, -8, -4, and 0 dB).

Myringotomy with and without tympanostomy tubes for chronic otitis media with effusion.

We studied 109 children with otitis media with effusion of 2 months' duration or longer that was unresponsive to medical management. Eighty-six subjects who had neither "significant" hearing loss nor defined symptoms were randomly assigned to receive myringotomy, myringotomy with tympanostomy tube insertion, or no surgery, and 23 subjects with significant hearing loss, defined symptoms, or both were randomly assigned to receive either myringotomy or myringotomy with tube insertion. Myringotomy with tube insertion provided more disease-free time and better hearing than either myringotomy alone or no surgery; however, some subjects who underwent myringotomy with tube insertion developed otorrhea or persistent perforation of the tympanic membrane.