scholarly journals Acyclovir Cream for Treatment of Herpes Simplex Labialis: Results of Two Randomized, Double-Blind, Vehicle-Controlled, Multicenter Clinical Trials

2002 ◽  
Vol 46 (7) ◽  
pp. 2238-2243 ◽  
Author(s):  
Spotswood L. Spruance ◽  
Robert Nett ◽  
Thomas Marbury ◽  
Ray Wolff ◽  
James Johnson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
The United States ◽  
Vehicle Control ◽  
Herpes Labialis ◽  
Double Blind ◽  
Number Of Patients ◽  
The Mean ◽  
Multicenter Clinical Trials ◽  
Acyclovir Cream

ABSTRACT Acyclovir cream has been available for the treatment of herpes labialis in numerous countries outside the United States for over a decade. Evidence for its efficacy comes from a few small clinical trials conducted in the 1980s. To examine more comprehensively the efficacy and safety of this formulation, we conducted two independent, identical, parallel, randomized, double-blind, vehicle-controlled, large-scale multicenter clinical trials. Healthy adults with a history of frequent herpes labialis were recruited from the general population, screened for eligibility, randomized equally to 5% acyclovir cream or vehicle control, given study medication, and told to self-initiate treatment five times daily for 4 days beginning within 1 h of the onset of a recurrent episode. The number of patients who treated a lesion was 686 in study 1 and 699 in study 2. In study 1, the mean duration of episodes was 4.3 days for patients treated with acyclovir cream and 4.8 days for those treated with the vehicle control (hazards ratio [HR] = 1.23; 95% confidence interval [CI], 1.06 to 1.44; P = 0.007). In study 2, the mean duration of episodes was 4.6 days for patients treated with acyclovir cream and 5.2 days for those treated with the vehicle control (HR = 1.24; 95% CI, 1.06 to 1.44; P = 0.006). Efficacy was apparent whether therapy was initiated “early” (prodrome or erythema lesion stage) or “late” (papule or vesicle stage). There was a statistically significant reduction in the duration of lesion pain in both studies. Acyclovir cream did not prevent the development of classical lesions (progression to vesicles, ulcers, and/or crusts). Adverse events were mild and infrequent.

scholarly journals High-Dose, Short-Duration, Early Valacyclovir Therapy for Episodic Treatment of Cold Sores: Results of Two Randomized, Placebo-Controlled, Multicenter Studies

2003 ◽  
Vol 47 (3) ◽  
pp. 1072-1080 ◽  
Author(s):  
Spotswood L. Spruance ◽  
Terry M. Jones ◽  
Mark M. Blatter ◽  
Mauricio Vargas-Cortes ◽  
Judy Barber ◽  
...  
Keyword(s):  
Day Treatment ◽  
High Dose ◽  
Herpes Labialis ◽  
Lesion Development ◽  
Multicenter Studies ◽  
Double Blind ◽  
Cold Sore ◽  
Treatment Groups ◽  
The Mean ◽  
Cold Sores

ABSTRACT Oral valacyclovir is better absorbed than oral acyclovir, increasing acyclovir bioavailability three- to fivefold. This provides the opportunity to explore whether high systemic acyclovir concentrations are effective in the treatment of cold sores (herpes labialis). Two randomized, double-blind, placebo-controlled studies were conducted. Subjects were provided with 2 g of valacyclovir twice daily for 1 day (1-day treatment), 2 g of valacyclovir twice daily for 1 day and then 1 g of valacyclovir twice daily for 1 day (2-day treatment), or a matching placebo and instructed to initiate treatment upon the first symptoms of a cold sore. In study 1, the median duration of the episode (primary endpoint) was reduced by 1.0 day (P = 0.001) with 1-day treatment and 0.5 days (P = 0.009) with 2-day treatment compared to placebo. Similarly, the mean duration of the episode was statistically significantly reduced by 1.1 days with 1-day treatment and 0.7 days with 2-day treatment compared to placebo. The proportion of subjects in whom cold sore lesion development was prevented and/or blocked was increased by 6.4% (P = 0.096) with 1-day treatment and 8.5% (P = 0.061) with 2-day treatment compared to placebo. The time to lesion healing and time to cessation of pain and/or discomfort were statistically significantly reduced with valacyclovir compared to placebo. In study 2, results similar to those in study 1 were obtained. AEs were similar across treatment groups. These studies provide evidence supporting a simple, 1-day valacyclovir treatment regimen for cold sores that is safe and effective. The 1-day valacyclovir regimen offers patients a unique and convenient dosing alternative compared to available topical therapies.

Modafinil Augmentation for Residual Symptoms of Fatigue in Patients with a Partial Response to Antidepressants

2007 ◽  
Vol 41 (6) ◽  
pp. 1005-1012 ◽  
Author(s):  
Jenny Y Lam ◽  
Maisha Kelly Freeman ◽  
Marshall E Cates
Keyword(s):  
Clinical Trials ◽  
Data Extraction ◽  
Controlled Clinical Trials ◽  
Open Label ◽  
Double Blind ◽  
Residual Symptoms ◽  
Randomized Controlled ◽  
Manual Search ◽  
Number Of Patients ◽  
Residual Fatigue

OBJECTIVE: To evaluate the literature discussing the use of modafinil in the treatment of residual symptoms of fatigue in patients with depression. DATA SOURCES: PubMed (1966–March 2007) and International Pharmaceutical Abstracts(1970–March 2007) were searched using the key words modafinil and depression. A manual search of the reference section of the articles retrieved was conducted to identify articles not indexed in either of these sources. STUDY SELECTION AND DATA EXTRACTION: All articles published in English were evaluated. Studies were included if modafinil was used to treat patients with residual fatigue from depression and the effects were measured with validated fatigue subscales. DATA SYNTHESIS: One retrospective study, 5 open-label trials, and 2 randomized controlled clinical trials met the inclusion criteria for assessment of residual symptoms of fatigue as assessed by commonly used fatigue subscales after modafinil administration. Although improvement with fatigue has occurred with modafinil therapy, literature regarding the topic is limited by the lack of well-controlled clinical trials. Modafinil does appear to improve residual fatigue with depression as evidenced by open-label trials; however, the efficacy of this agent has not been duplicated in randomized controlled trials. The open-label trials that have been conducted often had no comparator and a small number of patients. In addition, outcome measures used in the studies were not consistent between trials. Modafinil appears to be well tolerated, with the main adverse effects being headache and nausea. CONCLUSIONS: Open-label trials indicate that modafinil may be effective in ameliorating fatigue associated with depression; however, this effect has not been reproduced in randomized, double-blind, placebo-controlled clinical trials. Therefore, the use of modafinil for the treatment of residual fatigue is not recommended due to the lack of reproducible data of its efficacy. Long-term, adequately powered clinical trials should be conducted to determine its place in therapy.

The incidence of occult endocrinopathies in patients with cancer undergoing immunotherapy in community practice.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e14571-e14571
Author(s):  
Ahmed Abdalla ◽  
Aditi Singh ◽  
Hussein Gharib ◽  
Benjamin Huber ◽  
Sindhu Janarthanam Malapati ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Testosterone Level ◽  
Single Agent ◽  
Laboratory Data ◽  
Endocrine Function ◽  
Hormone Levels ◽  
Primary Indication ◽  
Number Of Patients ◽  
The Mean ◽  
Stimulating Hormone

e14571 Background: Immune checkpoint blockade (IO) can induce inflammation of the pituitary, thyroid or adrenal glands. This usually results in non-specific symptoms such as headache, low-energy, nausea and vomiting, which can be difficult to differentiate from symptoms associated with cancer and therapy-related symptoms. Therefore, the exact incidence of endocrinopathies is exceedingly difficult to estimate in community practices. Also, the variable methods of assessment, diagnosis, and monitoring used in different clinical trials make it challenging to precisely measure the incidence of endocrinopathies. Methods: This is a single-center retrospective chart review of patients diagnosed with cancer receiving immunotherapy for cancer treatment who had routine hormone levels checked during their treatment. Data collected includes tumor types and the types of IO agents used. Laboratory data collected included thyroid-stimulating hormone (TSH), testosterone level, follicular stimulating hormone (FSH), luteinizing hormone (LH), cortisol levels. Results: In total, 75 patients were included in the study. The primary indication for IO was lung cancer in 43 patients (57%), genitourinary tumors (12%), melanoma (12%) and head & neck cancers (5.3%). Single-agent nivolumab (39 patients) was the most common IO agent used followed by single-agent pembrolizumab (22 patients), ipilimumab (11 patients), atezolizumab (3 patients), avelumab (1 patient) (There was one patient who got nivolumab initially and then pembrolizumab). Nine patients were treated with ipilimumab/nivolumab combination. The mean number of cycles received was 9.1. The total number of patients who developed at least one abnormal hormone level was 57(76%), with 33 out of 74 (45%) patients had at least one abnormal TSH, 29 out of 44 (66%) patients had at least one abnormal testosterone level, 10 out of 49 (20.4%) patients had at least one abnormal FSH and/or LH level, 36 out of 52 (69%) patients had at least one abnormal cortisol level. The mean number of days from starting IO to develop the first abnormal laboratory result was 106 days. Conclusions: The incidence of endocrinopathy was significantly high in patients receiving IO in this study, which is higher than what is reported in previous clinical trials. This could be due to frequent testing in asymptomatic patients and strict laboratory cut-off values which is not always clinically meaningful. This finding may highlight the importance of routine monitoring of the endocrine function during IO treatment. Routine measurement of hormone levels can detect asymptomatic endocrinopathy which may warrant further work-up and treatment. These findings should be validated in a larger prospective study.

scholarly journals Comparison of the Nutrient Content of Eggs from Commercial and Village Chickens in Rural Malawi (P03-009-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Rochelle Werner ◽  
Bess Caswell ◽  
Kenneth Maleta ◽  
Christine Stewart
Keyword(s):  
Vitamin D3 ◽  
Large Scale ◽  
Nutrient Content ◽  
The United States ◽  
Water Soluble ◽  
Small Scale ◽  
Convenience Sample ◽  
Nutrient Analysis ◽  
The Mean ◽  
The Village

Abstract Objectives To characterize the nutritional composition of chicken eggs from a large-scale commercial producer and a small-scale household producer in rural Malawi. Methods A convenience sample of 28 large commercial and 32 village eggs from Malawi were hardboiled and measured for the weight in grams of the whole egg, peeled egg, egg white, and egg yolk. A separate convenience sample of 11 commercial and 17 village eggs were selected for nutrient analysis. Eggs were hardboiled for 4 minutes, refrigerated, and shipped to a nutrient analysis lab in the United States. Eggs from each source were pooled and analyzed for macronutrients, amino acids, fatty acids, vitamins, and minerals. Analytes were reported per 100 g sample and converted to nutrients per egg using the mean peeled egg weight. Results The mean weight in grams of whole commercial eggs (59.4 ± 5.3) was 19 g greater than whole village eggs (40.4 ± 3.0). Commercial eggs had a 15 g greater mass of egg whites (37.0 ± 4.2) than village eggs (21.8 ± 2.5), but the mass of egg yolks only differed by one gram (commercial: 15.3 ± 1.0 and village: 14.1 ± 1.4). Per 100 g sample, commercial and village eggs had similar calories (143 kcals vs. 162kcals), protein (12.5 g vs. 12.5 g), water-soluble vitamins (1.61 µg vs. 1.92 µg Vitamin B-12; 63.5 µg vs. 59.9 µg folate, DFE) and minerals (1.7 mg vs. 2.1 mg iron; 21 µg vs. 24 µg selenium; 1.1 mg vs. 1.4 mg zinc). For fat-soluble nutrients, the 100 g sample of commercial eggs had a higher concentration of Vitamin A than the village eggs (150 µg vs. 102 µg RAE) but lower concentrations of Vitamin D3, α-tocopherol, and choline than the village eggs (0.8 µg vs. 2.9 µg Vitamin D3; 2.25 mg vs. 4.08 mg α-tocopherol; and 238 mg vs. 314 mg choline). However, when compared on a per egg basis, the fat-soluble nutrient content of the whole eggs was similar due to the smaller size of the village eggs. Conclusions On a per egg basis, eggs from small-scale households may deliver comparable amounts of fat-soluble nutrients but fewer calories, protein, and minerals compared to eggs from commercial producers; however, on a per 100 g basis, village eggs were a more nutrient-dense option. Funding Sources The Bill and Melinda Gates Foundation, BLUM Center of UC Davis.

Distribution and geographic accessibility of prostate cancer clinical trials in the United States.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 59-59 ◽  
Author(s):  
Matt D. Galsky ◽  
Asma Latif ◽  
Kristian D. Stensland ◽  
Erin L. Moshier ◽  
Russell McBride ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Geographic Distribution ◽  
The United States ◽  
First Line ◽  
Trial Site ◽  
Lorenz Curves ◽  
Number Of Patients

59 Background: An extremely small proportion of patients with cancer in the United States (US) enroll in clinical trials. While several barriers to trial accrual have been described, the geographic distribution and accessibility of clinical trial sites has not been comprehensively explored. Methods: ClinicalTrials.gov was queried to identify all active US clinical trials exploring first-line therapies for metastatic prostate cancer (PCa) on 9/16/2012. We evaluated the geographic distribution of trial sites and determined the relationship between the number of sites and the number of patients with advanced PCa per county and evaluated heterogeneity using Lorenz curves. We also estimated the minimum driving distance required to access a clinical trial site from each ZIP code in the continguous US; a distance >30 miles was defined as high travel burden consistent with prior studies. Results: We identified 958 sites associated with 42 PCa clinical trials (Table). The geographic distribution of clinical trial sites was very inhomogeneous with several states having only 1-2 trial sites. Among 3185 US counties, 2,669 (83.8%) had no clinical trials available for first-line treatment of metastatic PCa. Counties with larger populations of patients with advanced PCa had significantly higher numbers of clinical trial sites. For every 100 additional patients with advanced PCa per county, the number of available trial sites increased by 21.0% (95% CI: 16.5-25.7%). However, Lorenz curves indicated a high degree of inequality in trial accessibility (Gini index 0.71). Approximately 31% of the US population resided >30 miles from a PCa trial site. Conclusions: Clinical trials sites are poorly accessible, geographically, to a large subset of US PCa patients, a finding that likely contributes to dismal accrual. Innovative solutions are required to address geographic barriers to access. [Table: see text]

The nature of the black–white difference on various psychometric tests: Spearman's hypothesis

1985 ◽  
Vol 8 (2) ◽  
pp. 193-219 ◽  
Author(s):  
Arthur R. Jensen
Keyword(s):  
Information Processing ◽  
Large Scale ◽  
The United States ◽  
Population Variation ◽  
General Factor ◽  
Black And White ◽  
The Mean ◽  
Relationship Of ◽  
Iq Tests ◽  
Mental Tests

AbstractAlthough the black and white populations in the United States differ, on average, by about one standard deviation (equivalent to 15 IQ points) on current IQ tests, they differ by various amounts on different tests. The present study examines the nature of the highly variable black–white difference across diverse tests and indicates the major systematic source of this between-population variation, namely, Spearman's g. Charles Spearman originally suggested in 1927 that the varying magnitude of the mean difference between black and white populations on a variety of mental tests is directly related to the size of the test's loading on g, the general factor common to all complex tests of mental ability. Eleven large-scale studies, each comprising anywhere from 6 to 13 diverse tests, show a significant and substantial correlation between tests' g loadings and the mean black–white difference (expressed in standard score units) on the various tests. Hence, in accord with Spearman's hypothesis, the average black–white difference on diverse mental tests may be interpreted as chiefly a difference in g, rather than as a difference in the more specific sources of test score variance associated with any particular informational content, scholastic knowledge, specific acquired skill, or type of test. The results of recent chronometric studies of relatively simple cognitive tasks suggest that the g factor is related, at least in part, to the speed and efficiency of certain basic information-processing capacities. The consistent relationship of these processing variables to g and to Spearman's hypothesis suggests the hypothesis that the differences between black and white populations in the rate of information processing may account for a part of the average black–white difference on standard IQ tests and their educational and occupational correlates.

scholarly journals Racial and Ethnic Enrollment Disparities and Demographic Reporting Requirements in Acute Leukemia Clinical Trials

2021 ◽  
Author(s):  
Andrew Hantel ◽  
Marlise R. Luskin ◽  
Jacqueline S Garcia ◽  
Wendy Stock ◽  
Daniel J DeAngelo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Native American ◽  
Acute Leukemia ◽  
Race And Ethnicity ◽  
Disease Incidence ◽  
The United States ◽  
Reporting Requirements ◽  
Number Of Patients ◽  
Hispanic Patients ◽  
Race Ethnicity

Data regarding racial and ethnic enrollment diversity for acute myeloid (AML) and lymphoid leukemia (ALL) clinical trials in the United States (US) are limited, and little is known about the effect of federal reporting requirements instituted in the late 2000s. We examined demographic data reporting and enrollment diversity for US ALL and AML trials from 2002-2017 as well as changes in reporting and diversity after reporting requirements were instituted. Of 223 AML and 97 ALL trials with results, 68 (30.5%) and 51 (52.6%) reported enrollment by both race and ethnicity. Among trials that reported race and ethnicity (AML N=6,554; ALL N=4,149), non-Hispanic (NH)-Black, NH-Native American, NH-Asian, and Hispanic patients had significantly lower enrollment compared to NH-white patients after adjusting for race-ethnic disease incidence (AML odds: 0.68, 0.31, 0.75, and 0.83; ALL: 0.74, 0.27, 0.67, and 0.64; all p≤0.01). The proportion of trials reporting race increased significantly after the reporting requirements (44.2 to 60.2%; p=0.02), but race-ethnicity reporting did not (34.8 to 38.6%; p=0.57). Reporting proportions by number of patients enrolled increased significantly after the reporting requirements (race: 51.7 to 72.7%, race-ethnicity: 39.5 to 45.4%; both p<0.001), and relative enrollment of NH-Black and Hispanic patients decreased (AML odds: 0.79 and 0.77; ALL: 0.35 and 0.25; both p≤0.01). These data suggest that demographic enrollment reporting for acute leukemia trials is suboptimal, changes in diversity after the reporting requirements may be due to additional enrollment disparities that were previously unreported, and enrollment diversification strategies specific to acute leukemia care delivery are needed.

scholarly journals T197. TREATMENT STRATEGIES FOR ULTRA-RESISTANT SCHIZOPHRENIAS

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S306-S307
Author(s):  
Octavian Vasiliu
Keyword(s):  
Electroconvulsive Therapy ◽  
Large Scale ◽  
Pragmatic Trial ◽  
Mood Stabilizers ◽  
Control Group ◽  
Double Blind ◽  
Meaningful Improvement ◽  
Treatment As Usual ◽  
Positive Effects ◽  
Number Of Patients

Abstract Background Treatment-resistant schizophrenias include a heterogeneous group of patients with significant individual and societal consequences, and a high number of these patients fail to respond to clozapine (almost 50%). Patients who did not respond to the second line antipsychotics are a challenge for their treating physicians and although many augmentation strategies have been tried, including other agents with antipsychotic properties, mood-stabilizers, antidepressants, glutamatergic agents and neuromodulation techniques. Methods A literature review was conducted in the main electronic databases (PubMed, Cochrane, EMBASE, CINAHL), and papers published between January 2000 and August 2019 were included. The search paradigm was “ultra-resistant schizophrenia” or “clozapine-resistant schizophrenia” or “add-on to schizophrenia” and non-proprietary names of currently marketed antipsychotics, mood stabilizers, antipsychotics, nootropics, “neuromodulation techniques” and “psychotherapy”. Results A number of 197 papers resulted from the primary search, and 45 papers remained after de-duplication and application of inclusion and exclusion criteria. Electroconvulsive therapy seems to be efficient and the response rate ranges from 37.5 to 100% in cases of ultra-resistant schizophrenia [1]. Transcranial direct-current stimulation (tDCS) lead to meaningful improvement in positive symptoms and overall symptomatology when compared to no standard treatment of the control group, in a 4 weeks trial [2]. A 21-week pragmatic trial did not find any significant lasting effect of the cognitive-behavioral therapy (CBT) on total symptoms of schizophrenia compared to treatment as usual, although improvements were detected [3]. Pharmacological augmentation of clozapine included amisulpride (results were not significant), memantine (positive effects, but the trial included a small number of patients), reboxetine (uncertain efficacy), ziprasidone (possible effective on negative and cognitive symptoms), aripiprazole (uncertain effect based on multiple trials), lamotrigine (not efficient), pimozide (not efficient), sertindole (no benefits detected, possible worsen psychosis in several cases), tetrabenazine (not effective), duloxetine (possible efficacy on negative and general psychopathology, but not on the executive cognitive functions), topiramate (no efficacy), valproic acid (possible efficacy, larger trials needed), risperidone (not efficient), donepezil (not efficient), mirtazapine (possible efficacy), sulpiride (possible efficacy in a subgroup of schizophrenia patients). Discussion Until now no single pharmacological augmentation strategy to clozapine has been proven superior to other in double-blind randomized, large-scale placebo-controlled data. Electroconvulsive therapy seems to be the only non-pharmacological technique with enough data to support its efficacy in ultra-resistant cases of schizophrenia. Other neuromodulatory techniques, like tDCS, are still in early phase of investigation, and psychotherapy does not have enough evidence to support its efficacy. References

An Exploration of the Effectiveness of the Fun For Wellness Online Intervention to Promote Health in Adults With Obesity: A Randomized Controlled Trial

2020 ◽  
pp. 263207702096873
Author(s):  
Isaac Prilleltensky ◽  
Adam McMahon ◽  
Nicholas D. Myers ◽  
Ora Prilleltensky ◽  
Samantha Dietz ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Health Status ◽  
Self Efficacy ◽  
Large Scale ◽  
Controlled Trial ◽  
Well Being ◽  
The United States ◽  
Double Blind ◽  
Randomized Controlled ◽  
Positive Direct

Fun For Wellness (FFW) is an online behavioral intervention developed to promote well-being by enhancing the self-efficacy of participants. The objective of this study was to evaluate the effectiveness of FFW to promote health in adults with obesity in the United States in a relatively uncontrolled setting. The study design was a large-scale, prospective, double-blind, parallel group randomized controlled trial. Data collection occurred at three time points: baseline, 30 days, and 60 days after baseline. There was evidence for a positive direct effect of FFW on physical health status ([Formula: see text] = 1.33, p = .005, d = 0.24) at 60 days after baseline. In addition, there was evidence of a positive indirect effect of FFW on mental health status at 60 days after baseline through psychological well-being self-efficacy ([Formula: see text] = 0.44, [0.05, 0.94]).

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