Vaginal distention (VD) is a validated model of birth‐related trauma in rats. Recently a mouse VD... more Vaginal distention (VD) is a validated model of birth‐related trauma in rats. Recently a mouse VD model was reported. Our study was originally conducted to evaluate the impact of age on VD in mice. This manuscript describes the study and reports on the lack of reproducibility of VD models in mice.
Background Consumption of a diet with high glycemic indices has been associated with inferior can... more Background Consumption of a diet with high glycemic indices has been associated with inferior cancer-specific outcomes in patients with early-stage colorectal cancer, but there is limited prospective evidence that alterations in dietary habits improves cancer outcomes. This study aimed to determine the feasibility and acceptability of following a low glycemic load (GL) diet in patients with stage I-III colorectal cancer. Methods Patients with stage I-III colorectal cancer, who completed definitive therapy, and consumed an average daily GL >150 participated in a 12-week tailored face-to-face dietary intervention with a target GL. This study followed a 2-stage design, with 4 planned cohorts, each with an assigned GL target and dietary intervention intensity. The primary endpoint of feasibility was determined by participant compliance, defined as an individual following the assigned GL ≥75% of the time. Compliance was determined using 24-hour telephone recalls. A cohort was deemed f...
4643 Background: Observational evidence associates energy balance factors, particularly diet, wit... more 4643 Background: Observational evidence associates energy balance factors, particularly diet, with survival in patients with colorectal cancer (CRC). Consumption of a diet with high glycemic indices has been associated with inferior cancer-specific outcomes, but there is limited prospective evidence that alterations in dietary habits improve cancer outcomes. This was a pilot study to determine the feasibility and acceptability of following a low glycemic load (GL) diet in patients with stage I-III CRC and to assess the nutritional resources necessary to follow the diet. Methods: 18 patients with stage I-III CRC, who completed definitive cancer therapy and consumed an avg daily GL > 150 participated in a 12 week, tailored, in-person dietary intervention with a target GL of ≤102. Compliance was assessed using 24 hour telephone recalls. Acceptability of the diet was assessed using a food acceptability questionnaire, and exploratory correlative laboratories were assessed monthly. Res...
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, Jan 18, 2018
As many as 45% of patients with gastroesophageal reflux disease (GERD) still have symptoms after ... more As many as 45% of patients with gastroesophageal reflux disease (GERD) still have symptoms after receiving once-daily proton pump inhibitor (PPI) therapy. We aimed to compare reflux characteristics and patterns between responders and non-responders to once-daily PPI therapy using combined impedance-pH monitoring. Patients who reported heartburn and/or regurgitation at least twice per week for 3 months while receiving standard-dose PPI therapy were assigned to the PPI failure group (n = 16). Patients who reported a complete resolution of symptoms on once-daily PPIs for at least 4 weeks were assigned to the PPI success group (n = 13). We collected demographic data and subjects completed the short-form 36 and the GERD health-related quality of life questionnaires. Patients then underwent upper endoscopy and combined esophageal impedance-pH monitoring while on PPI therapy. Four patients in the PPI success group (31%) and 4 patients in the PPI failure group (25%) had abnormal results fro...
Diabetes mellitus can cause various gastrointestinal symptoms. Assessment of esophageal dysmotili... more Diabetes mellitus can cause various gastrointestinal symptoms. Assessment of esophageal dysmotility in diabetic patients has been scarcely studied. The aim of this study was to determine the esophageal motor characteristics of diabetic versus nondiabetic patients who present with dysphagia. High-resolution esophageal manometries (HREMs) of 83 diabetic patients and 83 age and gender-matched nondiabetic patients with dysphagia from 2 medical centers were included in this study. Demographic information, medical comorbidities, and medication usage were recorded for each patient in a single registry. HREM of each patient was evaluated and the different functional parameters were recorded. Overall, 46% of diabetic patients were found to have an esophageal motor disorder. Diabetic patients with dysphagia were more likely to have failed swallows on HREM (50.6% vs. 33.7%; P=0.03) as compared with nondiabetic patients. Among diabetic patients, those being treated with insulin were more likely to have failed (69.0% vs. 40.7%; P=0.01) and weak (65.5% vs. 33.3%; P=0.005) swallows as compared with diabetic patients not on insulin. Among diabetic patients, those with abnormal manometry were more likely to demonstrate diabetic retinopathy (27.0% vs. 8.7%; P=0.04). There was a trend toward increased incidence of esophagogastric junction outflow obstruction in diabetic patients (10.8% vs. 2.4%; P=0.057) as compared with nondiabetic patients. Nearly half of diabetic patients with dysphagia have some type of an esophageal motility disorder. Diabetic retinopathy and the use of insulin are predictive of esophageal motor abnormalities among diabetic patients.
Early predictors of response and remission in pediatric mania are lacking, requiring further stud... more Early predictors of response and remission in pediatric mania are lacking, requiring further study. This was a post hoc analysis of a 3-week, randomized, placebo-controlled trial of olanzapine conducted between November 2002 and May 2005 in 161 adolescents aged 13-17 years who were diagnosed with a DSM-IV acute manic or mixed episode of bipolar I disorder. Data from the olanzapine arm were analyzed to investigate the predictive power of early response or early nonresponse (≥25% or < 25% reduction in Young Mania Rating Scale [YMRS] score, respectively) at week 1 for ultimate response or nonresponse (≥ 50% or < 50% reduction in YMRS score, respectively) and for remission (YMRS total score ≤ 12 [standard definition] or ≤ 8 [stringent definition]) at week 3. Correlates of early response and ultimate response were examined in multivariable regression models. By week 1, 69.2% of olanzapine-treated adolescents (n = 104, 2.5-20.0 mg/d) achieved early response, and 49.0% reached ultimate response at week 3. Patients with early response and early nonresponse were similar regarding baseline variables except higher scores for sleep and thought content were found with early response (P < .05) and higher olanzapine doses with early nonresponse (P < .01). At week 3, early response was associated with significantly greater improvements in YMRS, Clinical Global Impressions-Severity of Illness scale (both P < .001), and Overt Aggression Scale scores (P = .024). Adverse events were similar in patients with early response and early nonresponse, except for higher AIMS scores for patients with early nonresponse (P = .036). Early response significantly predicted ultimate response (OR = 5.61, P < .001; sensitivity = 86.3, specificity = 47.2, positive predictive value = 61.1, negative predictive value = 78.1). Significantly more early response than early nonresponse patients achieved ultimate response (61.1% vs 21.9%, P < .001) and remission defined by YMRS score ≤ 12 (45.8% vs 12.5%, P < .001) and YMRS score ≤ 8 (33.3% vs 3.1%, P < .001). In multivariable analyses, among other variables, early response remained an independent correlate of ultimate response and remission. In acute pediatric manic or mixed episodes, early response to olanzapine at week 1 was strongly associated with ultimate response and remission at week 3, while absence of early response predicted the unlikely success of further treatment. ClinicalTrials.gov identifier: NCT00050206.
This study aims to compare treatment response in bipolar I or II depression and generalized anxie... more This study aims to compare treatment response in bipolar I or II depression and generalized anxiety disorder (GAD) with and without recent alcohol and/or cannabis use disorder (ALC/CAN) to quetiapine-XR (extended release) or placebo. A randomized, double-blind, 8-week study of quetiapine-XR versus placebo in patients with bipolar I or II depression and GAD with or without a recent ALC/CAN was used to compare changes in Hamilton Depression Rating Scale-17, Hamilton Anxiety Rating Scale, the 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), Clinical Global Impression for Bipolar Disorder-Severity (CGI-BP-S), and Timeline Follow Back within and between groups. In the quetiapine-XR group, patients with a recent ALC/CAN (n = 22) had significant decreases in QIDS-SR-16 (-9.6 ± 1.6 vs. -3.7 ± 1.7) and CGI-BP-S (-1.6 ± 0.4 vs. -0.8 ± 0.03) than those without a recent ALC/CAN (n = 24). In the placebo group, both patients with a recent ALC/CAN (n = 23) and those w...
Vaginal distention (VD) is a validated model of birth‐related trauma in rats. Recently a mouse VD... more Vaginal distention (VD) is a validated model of birth‐related trauma in rats. Recently a mouse VD model was reported. Our study was originally conducted to evaluate the impact of age on VD in mice. This manuscript describes the study and reports on the lack of reproducibility of VD models in mice.
Background Consumption of a diet with high glycemic indices has been associated with inferior can... more Background Consumption of a diet with high glycemic indices has been associated with inferior cancer-specific outcomes in patients with early-stage colorectal cancer, but there is limited prospective evidence that alterations in dietary habits improves cancer outcomes. This study aimed to determine the feasibility and acceptability of following a low glycemic load (GL) diet in patients with stage I-III colorectal cancer. Methods Patients with stage I-III colorectal cancer, who completed definitive therapy, and consumed an average daily GL >150 participated in a 12-week tailored face-to-face dietary intervention with a target GL. This study followed a 2-stage design, with 4 planned cohorts, each with an assigned GL target and dietary intervention intensity. The primary endpoint of feasibility was determined by participant compliance, defined as an individual following the assigned GL ≥75% of the time. Compliance was determined using 24-hour telephone recalls. A cohort was deemed f...
4643 Background: Observational evidence associates energy balance factors, particularly diet, wit... more 4643 Background: Observational evidence associates energy balance factors, particularly diet, with survival in patients with colorectal cancer (CRC). Consumption of a diet with high glycemic indices has been associated with inferior cancer-specific outcomes, but there is limited prospective evidence that alterations in dietary habits improve cancer outcomes. This was a pilot study to determine the feasibility and acceptability of following a low glycemic load (GL) diet in patients with stage I-III CRC and to assess the nutritional resources necessary to follow the diet. Methods: 18 patients with stage I-III CRC, who completed definitive cancer therapy and consumed an avg daily GL > 150 participated in a 12 week, tailored, in-person dietary intervention with a target GL of ≤102. Compliance was assessed using 24 hour telephone recalls. Acceptability of the diet was assessed using a food acceptability questionnaire, and exploratory correlative laboratories were assessed monthly. Res...
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, Jan 18, 2018
As many as 45% of patients with gastroesophageal reflux disease (GERD) still have symptoms after ... more As many as 45% of patients with gastroesophageal reflux disease (GERD) still have symptoms after receiving once-daily proton pump inhibitor (PPI) therapy. We aimed to compare reflux characteristics and patterns between responders and non-responders to once-daily PPI therapy using combined impedance-pH monitoring. Patients who reported heartburn and/or regurgitation at least twice per week for 3 months while receiving standard-dose PPI therapy were assigned to the PPI failure group (n = 16). Patients who reported a complete resolution of symptoms on once-daily PPIs for at least 4 weeks were assigned to the PPI success group (n = 13). We collected demographic data and subjects completed the short-form 36 and the GERD health-related quality of life questionnaires. Patients then underwent upper endoscopy and combined esophageal impedance-pH monitoring while on PPI therapy. Four patients in the PPI success group (31%) and 4 patients in the PPI failure group (25%) had abnormal results fro...
Diabetes mellitus can cause various gastrointestinal symptoms. Assessment of esophageal dysmotili... more Diabetes mellitus can cause various gastrointestinal symptoms. Assessment of esophageal dysmotility in diabetic patients has been scarcely studied. The aim of this study was to determine the esophageal motor characteristics of diabetic versus nondiabetic patients who present with dysphagia. High-resolution esophageal manometries (HREMs) of 83 diabetic patients and 83 age and gender-matched nondiabetic patients with dysphagia from 2 medical centers were included in this study. Demographic information, medical comorbidities, and medication usage were recorded for each patient in a single registry. HREM of each patient was evaluated and the different functional parameters were recorded. Overall, 46% of diabetic patients were found to have an esophageal motor disorder. Diabetic patients with dysphagia were more likely to have failed swallows on HREM (50.6% vs. 33.7%; P=0.03) as compared with nondiabetic patients. Among diabetic patients, those being treated with insulin were more likely to have failed (69.0% vs. 40.7%; P=0.01) and weak (65.5% vs. 33.3%; P=0.005) swallows as compared with diabetic patients not on insulin. Among diabetic patients, those with abnormal manometry were more likely to demonstrate diabetic retinopathy (27.0% vs. 8.7%; P=0.04). There was a trend toward increased incidence of esophagogastric junction outflow obstruction in diabetic patients (10.8% vs. 2.4%; P=0.057) as compared with nondiabetic patients. Nearly half of diabetic patients with dysphagia have some type of an esophageal motility disorder. Diabetic retinopathy and the use of insulin are predictive of esophageal motor abnormalities among diabetic patients.
Early predictors of response and remission in pediatric mania are lacking, requiring further stud... more Early predictors of response and remission in pediatric mania are lacking, requiring further study. This was a post hoc analysis of a 3-week, randomized, placebo-controlled trial of olanzapine conducted between November 2002 and May 2005 in 161 adolescents aged 13-17 years who were diagnosed with a DSM-IV acute manic or mixed episode of bipolar I disorder. Data from the olanzapine arm were analyzed to investigate the predictive power of early response or early nonresponse (≥25% or < 25% reduction in Young Mania Rating Scale [YMRS] score, respectively) at week 1 for ultimate response or nonresponse (≥ 50% or < 50% reduction in YMRS score, respectively) and for remission (YMRS total score ≤ 12 [standard definition] or ≤ 8 [stringent definition]) at week 3. Correlates of early response and ultimate response were examined in multivariable regression models. By week 1, 69.2% of olanzapine-treated adolescents (n = 104, 2.5-20.0 mg/d) achieved early response, and 49.0% reached ultimate response at week 3. Patients with early response and early nonresponse were similar regarding baseline variables except higher scores for sleep and thought content were found with early response (P < .05) and higher olanzapine doses with early nonresponse (P < .01). At week 3, early response was associated with significantly greater improvements in YMRS, Clinical Global Impressions-Severity of Illness scale (both P < .001), and Overt Aggression Scale scores (P = .024). Adverse events were similar in patients with early response and early nonresponse, except for higher AIMS scores for patients with early nonresponse (P = .036). Early response significantly predicted ultimate response (OR = 5.61, P < .001; sensitivity = 86.3, specificity = 47.2, positive predictive value = 61.1, negative predictive value = 78.1). Significantly more early response than early nonresponse patients achieved ultimate response (61.1% vs 21.9%, P < .001) and remission defined by YMRS score ≤ 12 (45.8% vs 12.5%, P < .001) and YMRS score ≤ 8 (33.3% vs 3.1%, P < .001). In multivariable analyses, among other variables, early response remained an independent correlate of ultimate response and remission. In acute pediatric manic or mixed episodes, early response to olanzapine at week 1 was strongly associated with ultimate response and remission at week 3, while absence of early response predicted the unlikely success of further treatment. ClinicalTrials.gov identifier: NCT00050206.
This study aims to compare treatment response in bipolar I or II depression and generalized anxie... more This study aims to compare treatment response in bipolar I or II depression and generalized anxiety disorder (GAD) with and without recent alcohol and/or cannabis use disorder (ALC/CAN) to quetiapine-XR (extended release) or placebo. A randomized, double-blind, 8-week study of quetiapine-XR versus placebo in patients with bipolar I or II depression and GAD with or without a recent ALC/CAN was used to compare changes in Hamilton Depression Rating Scale-17, Hamilton Anxiety Rating Scale, the 16-item Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR-16), Clinical Global Impression for Bipolar Disorder-Severity (CGI-BP-S), and Timeline Follow Back within and between groups. In the quetiapine-XR group, patients with a recent ALC/CAN (n = 22) had significant decreases in QIDS-SR-16 (-9.6 ± 1.6 vs. -3.7 ± 1.7) and CGI-BP-S (-1.6 ± 0.4 vs. -0.8 ± 0.03) than those without a recent ALC/CAN (n = 24). In the placebo group, both patients with a recent ALC/CAN (n = 23) and those w...
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