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Gastroretentive bilayer tablets were designed to prolong the gastric residence time after oral administration and to achieve immediate release of lansoprazole and controlled release floating layer of clarithromycin to treat gastric ulcers. Instant release layer has a combination of super disintegrating agents. A combination of effervescent mechanism is used. HPMC K5 was used as swelling polymer and citric acid, sodium bicarbonate as gas generating agent to reduce the floating lag time. Bilayer floating tablets were prepared with varying proportions of instant layer and sustained release floating approaches. The prepared formulations were evaluated for various tablet and floating parameters. Tablet properties were found to be within the limits according to procedures prescribed in USP. They had a floating lag time around 3-7 seconds and floating time more than 24 hours. The cumulative % drug release in simulated gastric fluids after 10 hours was 70% - 95%. The mechanism of drug release was analyzed by fitting the release data into various kinetic models. It was found that all the formulations best fit the Higuchi's model. [ABSTRACT FROM AUTHOR]

Over the past three decades, oral controlled-release dosage forms have been developed due to their therapeutic advantages, such as ease of administration, patient compliance, and flexibility in formulation. However, this approach has faced physiological difficulties, such as the inability to contain and position the controlled drug delivery system within the desired region of the gastrointestinal tract (GIT) due to variable gastric emptying and motility. Venlafaxine is an antidepressant and a serotonin and norepinephrine reuptake inhibitor (SNRI). Its active metabolite, desvenlafaxine, works by blocking the reuptake of serotonin and norepinephrine, which are key neurotransmitters in mood regulation. Gastroretentive dosage forms can stay in the gastric region for several hours and significantly prolong the gastric residence time of drugs. Natural materials have been extensively used in drug delivery because they are readily available, cost-effective, eco-friendly, capable of many chemical modifications, potentially degradable, and compatible due to their natural origin. [ABSTRACT FROM AUTHOR]

Antiepileptic drugs are generally available as tablets for oral administration, but this can pose problems for patients who are unable to consume medications orally. Transdermal drug delivery is useful in such cases. There is therefore an unmet need for enhancement techniques with the potential of delivering high dose medications across the skin. The transdermal route of drug administration ensures systemic delivery of drug by applying a drug formulation onto intact as patch on healthy skin thus ensuring sustained drug release and bypass of first-pass metabolism. Transdermal drugs significantly deliver molecules in a potent quantity that overcome the conventional problems of oral dosing. Thus, the objective of the proposed study is to develop lamotrigene-loaded transdermal patch an effective substitute for the existing maintenance therapies used for controlling epileptic seizures. We embarked on the transdermal delivery of lamotrigene upon this scientific basis. [ABSTRACT FROM AUTHOR]

Background: To investigate the effects of methylphenidate (MPH) on components of working memory (WM) in attention-deficit hyperactivity disorder (ADHD) and determine the responsiveness of WM measures to MPH. Methods: Participants were a clinical sample of 50 children and adolescents with ADHD, aged 6 to 16 years old, who participated in an acute randomized, double-blind, placebo-controlled, crossover trial with single challenges of three MPH doses. Four components of WM were investigated, which varied in processing demands (storage versus manipulation of information) and modality (auditory-verbal; visual-spatial), each of which was indexed by a minimum of two separate measures. Results: MPH improved the ability to store visual-spatial information irrespective of instrument used, but had no effects on the storage of auditory-verbal information. By contrast, MPH enhanced the ability to manipulate both auditory-verbal and visual-spatial information, although effects were instrument specific in both cases. Conclusions: MPH effects on WM are selective: they vary as a function of WM component and measurement.

Reading comprehension is a very complex task that requires different cognitive processes and reading abilities over the life span. There are fewer studies of reading comprehension relative to investigations of word reading abilities. Reading comprehension difficulties, however, have been identified in two common and frequently overlapping childhood disorders: reading disability (RD) and attention-deficit/hyperactivity disorder (ADHD). The nature of reading comprehension difficulties in these groups remains unclear. The performance of four groups of adolescents (RD, ADHD, comorbid ADHD and RD, and normal controls) was compared on reading comprehension tasks as well as on reading rate and accuracy tasks. Adolescents with RD showed difficulties across most reading tasks, although their comprehension scores were average. Adolescents with ADHD exhibited adequate single word reading abilities. Subtle difficulties were observed, however, on measures of text reading rate and accuracy as well as on silent reading comprehension, but scores remained in the average range. The comorbid group demonstrated similar difficulties to the RD group on word reading accuracy and on reading rate but experienced problems on only silent reading comprehension. Implications for reading interventions are outlined, as well as the clinical relevance for diagnosis. (Contains 2 tables.)

Background: Conventional antifungals are becoming resistant against dermatophytosis due to development of recalcitrant tinea. These patients may get benefit from newer topical antifungals or combination therapy. Topical antifungal therapy is the mainstay in the treatment of dermatophytosis. Aims/Objectives: To evaluate the safety and effectiveness of topical amorolfine in tinea infection in real-world settings. Materials and Methods: This was a real-world retrospective study; data was collected from 106 centers across India on the usage of amorolfine in the management of tinea infections. The treatment response was evaluated at the end of 2 and 4 week. It was determined by the reduction in severity of the classic symptoms of disease viz. pruritus, burning sensation, erythema, and scaling and crusting at Week 2 and Week 4 of treatment. The severity of symptoms was classified and quantified as mild (1), moderate (2), and severe (3). Safety was determined based on the occurrence of any adverse events during the treatment. Results: An improvement in symptoms score was observed for all the classic symptoms of infection viz. pruritus, burning sensation, erythema, and scaling and crusting at Week 2 and Week 4 compared to baseline. Mean total symptom score (TSS) was reduced to 0.88 ± 1.19 from 7.18 ± 2.84 at week 4 (P < 0.05). Only 10 (0.73%) patients out of 1358 showed mild and non-treatment-related adverse events. Conclusion: Amorolfine alone or in combination therapy with oral antifungals in real world clinical setting represents an improved treatment strategy for patients with tinea infections. [ABSTRACT FROM AUTHOR]

Lipospheres offer a new approach to improve an aqueous solubility of BCS class-II drugs. Simvastatin is a third generation fibric acid derivative belonging to this class, employed clinically as a hypolipidemic agent to lessen the risk caused by atherosclerosis. An attempt was made to improve aqueous solubility of Simvastatin by aid of stearic acid and Paraffin oil. The factorial batches of the Simvastatin lipospheres were formulated by melt dispersion technique using 32 factorial design with variables X1- concentration of stearic acid and X2- concentration of paraffin oil and responses Y1 - % Drug Entrapment (% DE) and Y2 - % Drug Release (% DR). From the surface response graphs the optimized batch was formulated and evaluated for saturation solubility, in-vitro drug release studies. Significant improvement in the aqueous solubility of the drug in the Simvastatin lipospheres supports the applicability of lipospheres as a tool for improving aqueous solubility of the BCS class-II drugs. [ABSTRACT FROM AUTHOR]

Abstract Background The objective of the current study was to examine performance and correlates of performance on a decision-making card task involving risky choices (Iowa Gambling Task) in adolescents with ADHD and comparison controls. Forty-four participants with ADHD and 34 controls were administered measures of estimated intellectual ability, working memory, and the card task. Also, behavioural ratings were obtained from parents and teachers. Results Adolescents with ADHD scored lower on the measures of intellectual ability, working memory, and made less advantageous selections on the card task compared to controls. Performance on measures of intellectual ability and working memory were unrelated to card task performance in both the ADHD and control samples. Parent ratings of hyperactivity/impulsivity were significantly associated with card task performance in the adolescents with ADHD, but not in controls. Conclusion These findings demonstrate impaired decision-making in adolescents with ADHD, and the separability of motivational and executive function processes, supporting current dual pathway models of ADHD.

Background: An open-label pilot study of individualized homeopathy for attention deficit hyperactivity disorder (ADHD) was conducted to assess the potential for future studies with a focus on the feasibility of the recruitment plan and outcome measure schedules; identification of any group characteristics of participants who respond significantly to the therapy; and establishing the length of time required for an improvement in ADHD symptoms. Patients and Methods: Participants (aged 6-16) were recruited through community advertisement and outreach. Participants completed 1 screening and 9 individualized homeopathic follow-up consultations. ADHD symptoms were assessed using the Conners 3 - Parent Questionnaire administered at each consultation. The pre- and post-study difference in Conners Global Index - Parent (CGI-P) T-score was evaluated for each participant. Baseline data of those who showed a statistically significant improvement (responders) were compared to those who did not (non-responders). Results: 35 participants were enrolled over 11 months. 80% completed all 10 consultations in a median of 12.1 months. 63% had a statistically significant improvement in the primary outcome, first occurring after a mean of 4.5 visits. Overall scores for participants completing at least 2 data points decreased from a baseline median of 85.5 to 74.0 (p < 0.001, CI 95%). There were no significant baseline differences between responders and non-responders. No serious adverse events related to the therapy were reported. Conclusion: The change in the median CGI-P T-score from baseline to the end of this open-label pilot study was statistically significant. The research methods are feasible. Future studies are warranted. Trial registration: NCT01141634. © 2014 S. Karger GmbH, Freiburg [ABSTRACT FROM AUTHOR]

Adults with ADHD smoke cigarettes at a higher rate than normal subjects. Nicotine has been shown to significantly improve clinical ADHD symptoms as measured by the Clinical Global Impression scale (CGI) as well as by measures of attention, vigour and arousal in ADHD subjects. In this study we hypothesized that the allele 113bp in D15S1360 marker at CHRNA7 and the 2 bp deletion allele at CHRFAM7A are associated with increased smoking in a sample of 90 DSM-IV patients affected by Adult ADHD. Temperament and Character Inventory (TCI) scores were included as covariates in the analysis to distinguish the contribution of personality traits from the contribution of the nicotinic genes under investigation. Smoking status was determined from the medical history questionnaire, and there were 35 current smokers and 55 non-smokers. Single marker associations and the CHRNA7-CHRFAM7A interaction were calculated by logistic regression, considering the 113 bp and the −2 bp deletion in a dominant model. No association of these genes with smoking was observed. Similarly, no significant interaction between the genes was observed in the logistic model. However, Persistence score of the TCI was significantly associated with smoking status. Further investigation on the hypothesis of the molecular interaction between CHRNA7 and CHRFAM7A genes is warranted. [ABSTRACT FROM AUTHOR]

Performance-based measures and ratings of executive functions were examined in a sample of adolescents with attention deficit/hyperactivity disorder (ADHD) and comparison controls. Performance-based measures of executive function included inhibition, working memory, set shifting, and planning, and ratings of these same executive functions were completed by parents and teachers. Adolescents with ADHD demonstrated lower executive function performance than controls and displayed elevated ratings on the executive function ratings by parents and teachers. Significant associations were obtained between the performance-based measures and the parent and teacher ratings, but each measure was not uniquely associated with its respective scale on the rating scales. When performance-based measures and ratings were examined as predictors of ADHD status, the parent and teacher ratings entered as significant predictors of ADHD status. Further commonality analyses indicated that performance-based measures accounted for little unique variance in predicting ADHD status and also displayed little overlap with the behavioral ratings. These findings highlight the diagnostic utility of behavioral ratings of executive function in predicting ADHD status; however, behavioral ratings should not be assumed to be a proxy for performance on measures of executive function in clinical practice. [ABSTRACT FROM AUTHOR]

This study used principal components analysis to examine the structure of variables associated with pathological gambling. A large battery of questionnaires was administered to a sample of 141 gamblers who ranged from non-problem gamblers to severe pathological gamblers. We found a significant relationship between severity of pathological gambling and various measures of impulsivity, depression, anxiety, erroneous beliefs, and reports of early wins. Component analysis of these variables found four distinct components: emotional vulnerability, impulsivity, erroneous beliefs, and the experiences of wins. Component scores based on these components were regressed onto pathological gambling. Emotional vulnerability had the largest effect (β = 0.54), followed by early wins (β = 0.32), erroneous beliefs (β = 0.31), and impulsivity (β = 0.23). The overall model accounted for 53.4% of the variance of pathological gambling. The findings confirm the idea that there may be several different risk factors that explain the development of pathological gambling. [ABSTRACT FROM AUTHOR]

Background: The objective of the current study was to examine performance and correlates of performance on a decision-making card task involving risky choices (Iowa Gambling Task) in adolescents with ADHD and comparison controls. Forty-four participants with ADHD and 34 controls were administered measures of estimated intellectual ability, working memory, and the card task. Also, behavioural ratings were obtained from parents and teachers. Results: Adolescents with ADHD scored lower on the measures of intellectual ability, working memory, and made less advantageous selections on the card task compared to controls. Performance on measures of intellectual ability and working memory were unrelated to card task performance in both the ADHD and control samples. Parent ratings of hyperactivity/impulsivity were significantly associated with card task performance in the adolescents with ADHD, but not in controls. Conclusion: These findings demonstrate impaired decision-making in adolescents with ADHD, and the separability of motivational and executive function processes, supporting current dual pathway models of ADHD. [ABSTRACT FROM AUTHOR]

Children with attention-deficit hyperactivity disorder (ADHD) do not typically outgrow this condition in adolescence, which is a challenging period of development. Management of ADHD in adolescence requires specific accommodations. These include providing adolescents with as much control over treatment as possible, so that they perceive treatment to be widening their autonomy rather than limiting it. Wherever possible, medication needs to be long-acting to facilitate compliance and to minimize problems with rebound misbehaviour and moodiness. Comorbid psychiatric symptoms and syndromes need to be evaluated carefully both pre- and posttreatment. Ongoing psychoeducation and support can help to restructure the demands that an adolescent with ADHD faces at home and school so that they are more manageable. With active treatment it may be possible to prevent the serious morbidity associated with ADHD during this period and to lay a foundation for adulthood. [ABSTRACT FROM AUTHOR]

Objective: To ensure uniform design and evaluation of a clerkship curriculum for child and adolescent psychiatry teaching common disorders and problems in an efficient manner across 5 teaching sites and to include structures for continuous improvement.Method: The curriculum committee selected for course inclusion disorders and problems of child psychiatry that were commonly encountered by primary care physicians. Instruction methods that encouraged active student learning were selected. Course coordination across sites was encouraged by several methods: involving faculty, adopting a centralized examination format, and aligning teaching methods with examination format. Quantitative and qualitative methods were used to measure students' perceptions of the course's value. These evaluative results were reviewed, and course modifications were implemented and reevaluated.Results: The average adjusted student return rate for course evaluation questionnaires for the 3-year study period was 63%. Clerks' ratings of course learning value demonstrated that the course improved significantly and continually across all sites, according to a Scheffé post-hoc analysis. Analysis of student statements from focus-group transcripts contributed to course modifications, such as the Brief Focused Interview (BFI).Conclusions: Our curriculum in child psychiatry, which focused on common problems and used active learning methods, was viewed as a valuable learning experience by clinical clerks. Curriculum coordination across multiple teaching sites was accomplished by including faculty in the process and by using specific teaching and examination strategies. Structures for continuous course improvement were effective. [ABSTRACT FROM AUTHOR]

Purpose:The purpose of this study is to examine the relationships among self-reported screening measures of attention deficit hyperactivity disorder (ADHD), other psychiatric problems, and driving-related outcomes in a provincially representative sample of adults 18 years and older living in the province of Ontario, Canada. Methods:The study examined the results of the Centre for Addictions and Mental Health (CAMH) Ontario Monitor, an ongoing repeated cross-sectional telephone survey of Ontario adults over a 2-year period. Measures included ADHD measures (Adult ADHD Self-Report Scale-V1.1 [ASRS-V1.1], previous ADHD diagnosis, ADHD medication use); psychiatric distress measures (General Health Questionnaire [GHQ12], use of pain, anxiety, and depression medication); antisocial behavior measure (The Antisocial Personality Disorder Scale from the Mini-International Neuropsychiatric Interview [APD]); substance use and abuse measures (alcohol, cannabis, and cocaine), Alcohol Use Disorders Identification Test (AUDIT), Alcohol, Smoking and Substance Involvement Screening Test (ASSIST), driving-related outcomes (driving after drinking, driving after cannabis use, street racing, collisions in past year), and sociodemographics (gender, age, vehicle-kilometers traveled). Results:A total of 4,014 Ontario residents were sampled, of which 3,485 reported having a valid driver's license. Overall, 3.22% screened positive for ADHD symptoms on the ASRS-V1.1 screening tool. A greater percentage of those who screened positive were younger, reported previous ADHD diagnosis and medication use, distress, antisocial behavior, anti-anxiety and antidepressant medication use, substance use, and social problems compared to those who screened negative. However, there were no statistically significant differences between those who screened positive or negative for ADHD symptoms on self-reported driving after having 2 or more drinks in the previous hour; within an hour of using cannabis, marijuana, or hash; or in a street race or collision involvement as a driver in the past year. When a sequential regression was conducted to predict self-reported collisions, younger age and higher weekly kilometers driven showed higher odds of collision involvement, and the odds ratio for cannabis use ever approached statistical significance. Discussion:This study is the first population-based study of a representative sample of adults 18 years and older living in Ontario, Canada. These results showed no relationship between the ADHD screen and collision when age, sex, and kilometers driven are controlled for. However, these analyses are based on self-report screeners and not psychiatric diagnoses and a limited sample of ADHD respondents. Thus, these results should be interpreted with caution. [ABSTRACT FROM PUBLISHER]

Corresponding author: Maggie Toplak; e-mail: mtoplak@yorku.ca The conceptualization of the symptom structure in ADHD has implications for research and clinical conceptualizations of ADHD. The most recent conceptualization in factor analytic studies has separated inattention from hyperactivity and impulsivity. Our group examined the bifactor model as a framework for examining the factor analytic structure of ADHD (Toplak, Pitch, Flora, Iwenofu, Ghelani, Jain, and Tannock 2009). The bifactor model involves considering a general factor first, that includes the commonality among all symptoms, followed by specific factors that include the remaining variance after the general factor has been taken into account. We tested correlated and bifactor models in a sample of 201 adolescents referred for ADHD. A bifactor model with two specific factors best accounted for adolescent ADHD symptoms, according to both parent and adolescent interview data, and also in parent and teacher questionnaire data. The idea of a general factor is consistent with models that acknowledge the integral associations between inattention, hyperactivity, and impulsivity. This is also consistent with theoretical models that recognize the multiple pathways that interact synergistically to give rise to the phenotypic presentation of ADHD. [ABSTRACT FROM AUTHOR]

Introduction: Partial nephrectomy remains the gold standard in the management of small renal masses. However, minimally invasive partial nephrectomy (MIPN) is associated with a steep learning curve, and optimal, standardized techniques for time-efficient hemostasis are poorly described. Given the relative lack of evidence, the goal was to describe a set of actionable guiding principles, through an expert working panel, for urologists to approach hemostasis without compromising warm ischemia or oncological outcomes. Methods: A three-step modified Delphi method was used to achieve expert agreement on the best practices for hemostasis in MIPN. Panelists were recruited from the Canadian Update on Surgical Procedures (CUSP) Urology Group, which represent all provinces, academic and community practices, and fellowship- and non-fellowship-trained surgeons. Thirty-two (round 1) and 46 (round 2) panellists participated in survey questionnaires, and 22 attended the in-person consensus meeting. Results: An initial literature search of 945 articles (230 abstracts) underwent screening and yielded 24 preliminary techniques. Through sequential survey assessment and in-person discussion, a total of 11 strategies were approved. These are temporally distributed prior to tumor resection (five principles), during tumor resection (two principles), and during renorrhaphy (four principles). Conclusions: Given the variability in tumor size, depth, location, and vascularity, coupled with limitations of laparoscopic equipment, achieving consistent hemostasis in MIPN may be challenging. Despite over two decades of MIPN experience, limited evidence exists to guide clinicians. Through a three-step Delphi method and rigorous iterative review with a panel of experts, we ascertained a guiding checklist of principles for newly beginning and practicing urologists to reference. [ABSTRACT FROM AUTHOR]

Background Multiparametric MRI has led to increased detection of clinically significant prostate cancer (csPCa). Micro-US is being investigated for csPCa detection. Purpose To compare multiparametric MRI and micro-US in detecting csPCa (grade group ≥2) and to determine the proportion of MRI nodules visible at micro-US for real-time targeted biopsy. Materials and methods This prospective, single-center trial enrolled biopsy-naive men with suspected prostate cancer (PCa) between May 2019 and September 2020. All patients underwent multiparametric MRI followed by micro-US; findings at both were interpreted in a blinded fashion, followed by targeted biopsy and nontargeted systematic biopsy using micro-US. Proportions were compared using the exact McNemar test. The differences in proportions were calculated. Results Ninety-four men (median age, 61 years; IQR, 57-68 years) were included. MRI- and micro-US-targeted biopsy depicted csPCa in 37 (39%) and 33 (35%) of the 94 men, respectively ( P = .22); clinically insignificant PCa in 14 (15%) and 15 (16%) ( P > .99); and cribriform and/or intraductal PCa in 14 (15%) and 13 (14%) ( P > .99). The MRI- plus micro-US-targeted biopsy pathway depicted csPCa in 38 of the 94 (40%) men. The addition of nontargeted systematic biopsy to MRI- plus micro-US-targeted biopsy did not enable identification of any additional men with csPCa but did help identify nine additional men with clinically insignificant PCa ( P = .04). Biopsy was avoided in 32 of the 94 men (34%) with MRI and nine of the 94 men (10%) with micro-US ( P < .001). Among 93 MRI targets, 62 (67%) were prospectively visible at micro-US. Conclusion MRI and micro-US showed similar rates of prostate cancer detection, but more biopsies were avoided with the MRI pathway than with micro-US, with no benefit of adding nontargeted systematic biopsy to the MRI- plus micro-US-targeted biopsy pathway. Most MRI lesions were prospectively visible at micro-US, allowing real-time targeted biopsy. ClinicalTrials.gov registration no.: NCT03938376 © RSNA, 2022 Online supplemental material is available for this article.

Background: To investigate the impact of exogenous covert attention on chromatic (blue and red) and achromatic visual perception in adults with and without Attention Deficit Hyperactivity Disorder (ADHD). Exogenous covert attention, which is a transient, automatic, stimulus-driven form of attention, is a key mechanism for selecting relevant information in visual arrays., Methods: 30 adults diagnosed with ADHD and 30 healthy adults, matched on age and gender, performed a psychophysical task designed to measure the effects of exogenous covert attention on perceived color saturation (blue, red) and contrast sensitivity., Results: The effects of exogenous covert attention on perceived blue and red saturation levels and contrast sensitivity were similar in both groups, with no differences between males and females. Specifically, exogenous covert attention enhanced the perception of blue saturation and contrast sensitivity, but it had no effect on the perception of red saturation., Conclusion: The findings suggest that exogenous covert attention is intact in adults with ADHD and does not account for the observed impairments in the perception of chromatic (blue and red) saturation.

Objectives: To test the retinal dopaminergic hypothesis, which posits deficient blue color perception in ADHD, resulting from hypofunctioning CNS and retinal dopamine, to which blue cones are exquisitely sensitive. Also, purported sex differences in red color perception were explored., Methods: 30 young adults diagnosed with ADHD and 30 healthy young adults, matched on age and gender, performed a psychophysical task to measure blue and red color saturation and contrast discrimination ability. Visual function measures, such as the Visual Activities Questionnaire (VAQ) and Farnsworth-Munsell 100 hue test (FMT), were also administered., Results: Females with ADHD were less accurate in discriminating blue and red color saturation relative to controls but did not differ in contrast sensitivity. Female control participants were better at discriminating red saturation than males, but no sex difference was present within the ADHD group., Conclusion: Poorer discrimination of red as well as blue color saturation in the female ADHD group may be partly attributable to a hypo-dopaminergic state in the retina, given that color perception (blue-yellow and red-green) is based on input from S-cones (short wavelength cone system) early in the visual pathway. The origin of female superiority in red perception may be rooted in sex-specific functional specialization in hunter-gather societies. The absence of this sexual dimorphism for red colour perception in ADHD females warrants further investigation.

Background: An open-label pilot study of individualized homeopathy for attention deficit hyperactivity disorder (ADHD) was conducted to assess the potential for future studies with a focus on the feasibility of the recruitment plan and outcome measure schedules; identification of any group characteristics of participants who respond significantly to the therapy; and establishing the length of time required for an improvement in ADHD symptoms., Patients and Methods: Participants (aged 6-16) were recruited through community advertisement and outreach. Participants completed 1 screening and 9 individualized homeopathic follow-up consultations. ADHD symptoms were assessed using the Conners 3 - Parent Questionnaire administered at each consultation. The pre- and post-study difference in Conners Global Index - Parent (CGI-P) T-score was evaluated for each participant. Baseline data of those who showed a statistically significant improvement (responders) were compared to those who did not (non-responders)., Results: 35 participants were enrolled over 11 months. 80% completed all 10 consultations in a median of 12.1 months. 63% had a statistically significant improvement in the primary outcome, first occurring after a mean of 4.5 visits. Overall scores for participants completing at least 2 data points decreased from a baseline median of 85.5 to 74.0 (p < 0.001, CI 95%). There were no significant baseline differences between responders and non-responders. No serious adverse events related to the therapy were reported., Conclusion: The change in the median CGI-P T-score from baseline to the end of this open-label pilot study was statistically significant. The research methods are feasible. Future studies are warranted., Trial Registration: NCT01141634., (© 2014 S. Karger GmbH, Freiburg.)

Increasing data advocates the wider use of partial nephrectomy for renal tumours amenable to this approach. We describe the initial North American use of a novel parenchymal clamp in an open and a laparoscopic partial nephrectomy. Initial results in 3 patients (2 open, 1 laparoscopic) demonstrate excellent preservation of renal function and good oncologic outcomes. Hilar dissection was avoided in all cases and the estimated blood loss was low. In our small series, we found this device to be a safe and useful adjunct to partial nephrectomy.