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BACKGROUND: Male sex workers (MSWs), specifically cisgender men who exchange sex for money, goods, drugs, or other items of value with other cisgender men, are at high risk for HIV infection. Compared to men not engaged in sex work, MSWs are more likely to engage in frequent condomless sex with paying and non-paying sexual partners. While MSWs are often included as a subgroup of gay and bisexual men, data show that a large proportion identify as heterosexual; additionally, most MSWs do not identify as sex workers. This places MSWs in a unique position where they may not engage with traditional HIV prevention programs, and when they do, they may not feel comfortable, leading to poor retention. Thus, HIV prevention interventions that address MSWs unique life circumstances and provide support in exploring their sexual health options are needed. METHODS: In this protocol paper, we describe the design and procedures for a National Institute of Health-funded, randomized controlled trial testing the efficacy of PrEPare for Work,- a theory-based, manualized PrEP uptake and adherence intervention for MSW - using a 2-stage randomization design. Stage 1: MSWs are equally randomized to receive either the PrEPare for Work Stage 1 intervention (strength-based case management and facilitated PrEP linkage) or Standard of Care (SOC) to evaluate successful PrEP uptake (prescription filled) within two months post-randomization. Stage 2: Those who initiate PrEP are then equally re-randomized to receive either the PrEPare for Work Stage 2 intervention (1-on-1 skills training, problem-solving, and motivational interviewing adherence counseling and personalized, daily text message reminders) or SOC to assess adherence (Tenofovir concentrations in hair) over 12 months of follow up. Planned analyses will examine intervention efficacy, specific conceptual mediators, and hypothesized moderators. DISCUSSION: Based on our extensive preliminary research, multi-component, theory-informed interventions targeting this subpopulation of MSWs unique life circumstances are urgently needed. In this study, we are evaluating whether PrEPare for Work can improve PrEP uptake and adherence among MSWs. If this intervention is efficacious, it would be readily disseminated to diverse community organizations that serve MSWs and possibly other community or clinic-based settings. TRIAL REGISTRATION: ClinicalTrials.gov number NCT05736614, registered February 8, 2023.

Abstract Background Male sex workers (MSWs), specifically cisgender men who exchange sex for money, goods, drugs, or other items of value with other cisgender men, are at high risk for HIV infection. Compared to men not engaged in sex work, MSWs are more likely to engage in frequent condomless sex with paying and non-paying sexual partners. While MSWs are often included as a subgroup of gay and bisexual men, data show that a large proportion identify as heterosexual; additionally, most MSWs do not identify as “sex workers.” This places MSWs in a unique position where they may not engage with traditional HIV prevention programs, and when they do, they may not feel comfortable, leading to poor retention. Thus, HIV prevention interventions that address MSWs’ unique life circumstances and provide support in exploring their sexual health options are needed. Methods In this protocol paper, we describe the design and procedures for a National Institute of Health-funded, randomized controlled trial testing the efficacy of “PrEPare for Work,”— a theory-based, manualized PrEP uptake and adherence intervention for MSW — using a 2-stage randomization design. Stage 1: MSWs are equally randomized to receive either the “PrEPare for Work Stage 1 intervention” (strength-based case management and facilitated PrEP linkage) or Standard of Care (SOC) to evaluate successful PrEP uptake (prescription filled) within two months post-randomization. Stage 2: Those who initiate PrEP are then equally re-randomized to receive either the “PrEPare for Work Stage 2 intervention” (1-on-1 skills training, problem-solving, and motivational interviewing adherence counseling and personalized, daily text message reminders) or SOC to assess adherence (Tenofovir concentrations in hair) over 12 months of follow up. Planned analyses will examine intervention efficacy, specific conceptual mediators, and hypothesized moderators. Discussion Based on our extensive preliminary research, multi-component, theory-informed interventions targeting this subpopulation of MSWs’ unique life circumstances are urgently needed. In this study, we are evaluating whether “PrEPare for Work” can improve PrEP uptake and adherence among MSWs. If this intervention is efficacious, it would be readily disseminated to diverse community organizations that serve MSWs and possibly other community or clinic-based settings. Trial registration ClinicalTrials.gov number NCT05736614, registered February 8, 2023.

Introduction: Coronavirus disease 2019 (COVID-19) has impacted researchers' ability to continue to deliver HIV prevention and treatment interventions face to face. Although telehealth has been an important strategy to maintain research operations during the current pandemic, participants at increased risk of or living with HIV are often at higher risk of also experiencing poverty, housing instability, and other challenges that may present obstacles to successful remote delivery. Methods: We provide descriptions of remote adaptations to two randomized controlled efficacy trials of behavioral interventions for primary and secondary HIV prevention with descriptive enrollment and retention data. Results and Conclusions: Best practices for implementing telemedicine and e-health procedures are discussed, including procedures for addressing remote participation barriers (economic, health literacy, etc.) and other challenges, such as building rapport and staff support (NCT03092531 and NCT03175159).

This cluster-randomized efficacy trial evaluated the impact of the Ready for Wages intervention, a classroom-based social skills program designed to improve the employability of youth living and being educated in juvenile justice settings. Fifteen juvenile justice facility schools participated. Data were collected from 118 classrooms: 59 treatment and 59 business-as-usual control. There were no statistically significant differences across conditions on the outcome measures, although differences favored the intervention group. Implementation was hampered by challenges associated with conducting research in authentic juvenile settings during the COVID-19 pandemic. Only half of the planned data collection could be completed. Despite the null findings of this study, more research in juvenile justice facilities is warranted to identify evidence-based practices that support prosocial behavior. Group intervention offers a cost-effective approach to reducing recidivism in a very high-risk population, with potential benefits for individuals and society in general. [ABSTRACT FROM AUTHOR]

Implementation strategies used to enhance the implementation of interventions during efficacy and effectiveness studies are rarely reported. Tracking and reporting implementation strategies during these phases has potential to improve future research studies and real-world implementation. We present an exemplar of how this might be executed by specifying and reporting the implementation strategies that were used during a school-based efficacy trial, Project POWER, which tested a trauma-informed prevention program delivered by a university research team, community members, and school staff facilitators in 29 schools. Following the conclusion of the 4-year trial, core Project POWER research team members identified the implementation strategies that supported intervention delivery during the trial using an established taxonomy of school-based implementation strategies. The actors, actions, action targets, temporality, dose, and implementation outcomes were specified using established implementation strategies reporting guidelines. The research team identified 37 implementation strategies that were used during the Project POWER trial. Most strategies fell within the categories of Train and Educate Stakeholders, Use Evaluative and Iterative Strategies, and Develop Stakeholder Interrelationships. Actors included members of the research team and partner schools. Strategies were used multiple times during the preparation and implementation phases. Action targets were most often characteristics of individuals, implementation process, and characteristics of the inner setting. Strategies predominantly targeted the implementation outcomes of fidelity, acceptability, feasibility, and adoption. This study provided evidence that implementation strategies are used and can be identified in efficacy research using a retrospective approach. Identifying and specifying implementation strategies used during the initial phases of the translational research pipeline can inform the implementation strategies that are carried forward, adapted, or discontinued in future trials and routine practice to improve implementation and effectiveness outcomes.

Introduction: Coronavirus disease 2019 (COVID-19) has impacted researchers' ability to continue to deliver HIV prevention and treatment interventions face to face. Although telehealth has been an important strategy to maintain research operations during the current pandemic, participants at increased risk of or living with HIV are often at higher risk of also experiencing poverty, housing instability, and other challenges that may present obstacles to successful remote delivery. Methods: We provide descriptions of remote adaptations to two randomized controlled efficacy trials of behavioral interventions for primary and secondary HIV prevention with descriptive enrollment and retention data. Results and Conclusions: Best practices for implementing telemedicine and e-health procedures are discussed, including procedures for addressing remote participation barriers (economic, health literacy, etc.) and other challenges, such as building rapport and staff support (NCT03092531 and NCT03175159). [ABSTRACT FROM AUTHOR]

Abstract Background About half of Swedish eating disorder patients report exercising compulsively and compulsive exercise (CE) is prevalent in all diagnoses and both genders. Yet there are no systematic treatments targeting CE in specialist care. This study aims to evaluate the effects of The CompuLsive Exercise Activity TheraPy (LEAP) - a promising group treatment targeting compulsive exercise, in Swedish eating disorder patients. Method One hundred twenty-eight adult females and males suffering from anorexia nervosa, bulimia nervosa or other specified feeding and eating disorders (type 1, 2, or 4) with CE will be recruited via four specialist eating disorder treatment units. Participants will be randomized to receive treatment as usual (control group) or treatment as usual plus LEAP (intervention group). The groups will be assessed on key variables (e.g., BMI, eating disorder symptoms, exercise cognitions and behaviors) at three occasions: initially, after 3 months and after 6 months. Discussion The project takes place in a clinical setting, including both male and female patients with different eating disorder diagnoses with CE, enabling a good indication of the efficacy of LEAP. If our results are positive, LEAP has the potential of benefiting about half of the eating disorder population, with remission and recovery hopefully improving as a result. Trial registration The trial is registered with the ISRCTN registry (registration date 2020-03-25), trial ID: ISRCTN80711391 .

Abstract Background Major Depressive Disorder (MDD) is a disabling mood disorder, profoundly affecting a large number of adolescent’s quality of life. To date, no obvious treatment of choice for MDD in adolescents is available and progress in the treatment of depressed adolescents will have important public health implications. Attachment-Based Family Therapy (ABFT), as the only empirically supported family therapy model designed to treat adolescent depression, aims to repair interpersonal ruptures and rebuild an emotionally protective parent–child relationship. Objective To study the effectiveness of ABFT compared with treatment as usual (TAU) delivered within child- and adolescent mental health services (CAMHS) to adolescents with MDD. Method Sixty adolescents (86.7% girls), aged 13–18 years (M = 14.9, SD = 1.35), with MDD referred to two CAMHS were randomized to 16 weeks of ABFT or TAU. ABFT consisted of weekly therapy sessions (family/individual or both) according to the treatment manual. TAU was not monitored. Primary outcomes were assessed by blinded evaluators at baseline and post-treatment with the Hamilton Depression Scale (HAMD). Self-reported (Beck Depression Inventory-II, BDI-II) depressive symptoms were assessed at baseline, and after 4, 6, 8, 10,12, 14, and 16 weeks. Analyses were performed according to intent-to-treat principles. Results At post-treatment, clinician-rated remission rates on the HAMD (5% in ABFT and 3.33% in TAU, p = 1, OR = 1.54, Fisher’s exact test) and self-reported symptoms of depression on the BDI-II did not differ significantly between groups (X 2 [2, N = 60] = 0.06, p = 0.97). In both treatment groups participants reported significantly reduced depressive symptoms, but the majority (63.3%) of adolescents were still in the clinical range after 16 weeks of treatment. Conclusion ABFT was not superior to TAU. Remission and response rates were low in both groups, suggesting none of the treatments were effective in treating MDD in adolescents. Findings must be viewed in the context of the study’s small sample size, missing data, and implementation challenges. Continued efforts to improve treatment for MDD in outpatient clinics are warranted. Future research should examine moderators of and mechanisms for individual differences to treatment response, as well as the feasibility and cost-effectiveness of implementing treatment models which may require extensive training and expertise to yield clinically meaningful improvements in non-research settings. Trial registration Clinicaltrials.gov identifier: NCT01830088 https://clinicaltrials.gov/ct2/show/NCT01830088?term=Villab%C3%B8&draw=2&rank=1 Date of registration: April 12, 2013

Chicory can be used as herbal medicine against different ailments and also added to daily diet as vegetable or animal feed. An efficacy trial was conducted to assess the potential of this plant against liver disorders using rodent modeling. The trials comprised two modules i.e., normal diet and chicory-based supplemented diet. Moreover, experimental animals (rats) were divided into six groups with both modules including C0 (control diet), C1 (Chicory root containing diet), C2 (chicory seed containing diet), C3 (chicory stem containing diet) and C4 (chicory leaf containing diet). During 56 days of the trial period, serum lipid profile, liver and renal functioning tests were performed. The highest feed and water intake, as well as weight gain, was noted in control (C0) trailed by C1, C2, C3, C4 and C5 group in an experimental trial, respectively. The resultant diet C2 lowered the liver alkaline phosphatase level (ALP) from C0 (240.72±3.35) to 203.52±2.08 (C2), respectively. Similarly, C2 significantly lowered the ALT from 60.28±2.23 (C0) & 57.58±0.91 (C2) in rats. Moreover, C2 treatment showed a maximum reduction of AST from 145.13±2.10 (C0) to 134.52±1.24 (C2), respectively. Convincingly, chicory-based diet may be employed as an alternative to medication in the prevention and treatment of hypercholesterolemia and hepatic malfunctioning. [ABSTRACT FROM AUTHOR]

Abstract Background The spices based dietary interventions are in lime light among the scientific community owing to their promising therapeutic perspective. The bioactive components in spices can be used to exert various health promoting functions in human body such as prompting weight loss, inhibit diet-induced obesity, hypercholesterolemia, hyperglycemia, allergies and various other maladies. In current study extraction and in vitro characterization of coriander seed (CS), black cumin seed (BCS) and fenugreek seed (FS) polyphenols was conducted for further development of dietary intervention against lipid and glycemia related abnormalities in experimental Sprague Dowley rats fed with control and different spice powder supplemented diets. Methods Purposely, extraction of Coriander (CS), Black cumin (BCS) and Fenugreek seeds (FS) were carried out by using water and aqueous methanol (70:30 v/v). Afterwards, the resultant extracts were thoroughly investigated for their antioxidant potential through different indices like TPC, TFC, FRAP and β Carotene Bleaching Assay and ABTS. Furthermore, HPLC quantification were also conducted with special reference to thymoquinone, disogenin, chlorogenic acid, caffeic acid and kaempferol alongside in vitro pancreatic lipase inhibitory activity estimation. Bio-evaluation trial was consisting of three modules i.e. study-I (normal diet), study-II (high cholesterol diet) and study-III (high sucrose diet). Furthermore, rats were sub-divided in five groups in each module on the basis of diet provision including T0 (control), T1 (Diet containing CS), T2 (Diet containing BCS), T3 (Diet containing FS) and T4 (Diet containing CSP + BCSP + FSP). At the beginning of trial, some rats were dissected to evaluate the baseline values whilst rest of the rats was killed at the termination (56th day). Feed and drink intakes were quantified on daily bases whereas, body weight was calculated weekly. Cholesterol level, serum low density lipoproteins (LDL), high density lipoproteins (HDL), triglycerides, glucose concentration and insulin level of collected sera was measured by standard procedures. Results The in vitro characterization showed better extraction of spices antioxidant through aqueous methanol as compared to water. Among the spices, Black cumin seed alone or in combination revealed highest antioxidant activity in T2 (BCS) followed by T4 (CS + BCS), T7 (CS + BCS + FS), T1 (CS), T6 (BCS + FS), T5 (CS + FS) and lowest in T3 (FS). Likewise, the HPLC characterization showed the presence of thymoquinone in BCS, Dosignienin FGS and chlorogenic acid, caffeic acid and kaempferol in the other treatments. Furthermore, all the treatments showed dose dependent inhibition in Pancreatic lipase activity and order of inhibition was BCS > CS + BCS > CS + BCS + FS > CS > BCS + FC > CS + FS > FS. The maximum feed intake, drink intake and weight gain was observed in T0 (control) trailed by T1, T2, T3 and T4 group in experimental study I, II and III, respectively. The resultant diet T4 enhanced the high density lipoprotein from T0 (58.58 ± 2.51) to 61.71 ± 1.62 (T4) in hypercholesterolemia rats whereas in hyperglycaemia rats the HDL was varied from 38.77 ± 1.2 to 40.02 ± 0.99 in T0 and T4, respectively. Similarly, T2 significantly lowered the low density lipoprotein from 62.53 ± 1.22 (T1) & 46.53 ± 0.99 to 54.88 ± 0.52 & 40.94 ± 1.99 (T2) in hypercholesteraemic and diabetic rats. Moreover, T4 treatment showed maximum reduction as 10.01 & 11.53% in respective studies. Conclusions The diet prepared from the different combination of spices has been proven effective against Oxidative stress related physiological malfunctioning.

Outbreaks of emerging pathogens pose unique methodological and practical challenges for the design, implementation, and evaluation of vaccine efficacy trials. Lessons learned from COVID-19 highlight the need for innovative and flexible study design and application to quickly identify promising candidate vaccines. Trial design strategies should be tailored to the dynamics of the specific pathogen, location of the outbreak, and vaccine prototypes, within the regional socioeconomic constraints. Mathematical and statistical models can assist investigators in designing infectious disease clinical trials. We introduce key challenges for planning, evaluating, and modelling vaccine efficacy trials for emerging pathogens.

Background: About half of Swedish eating disorder patients report exercising compulsively and compulsive exercise (CE) is prevalent in all diagnoses and both genders. Yet there are no systematic treatments targeting CE in specialist care. This study aims to evaluate the effects of The CompuLsive Exercise Activity TheraPy (LEAP) - a promising group treatment targeting compulsive exercise, in Swedish eating disorder patients. Method: One hundred twenty-eight adult females and males suffering from anorexia nervosa, bulimia nervosa or other specified feeding and eating disorders (type 1, 2, or 4) with CE will be recruited via four specialist eating disorder treatment units. Participants will be randomized to receive treatment as usual (control group) or treatment as usual plus LEAP (intervention group). The groups will be assessed on key variables (e.g., BMI, eating disorder symptoms, exercise cognitions and behaviors) at three occasions: initially, after 3 months and after 6 months. Discussion: The project takes place in a clinical setting, including both male and female patients with different eating disorder diagnoses with CE, enabling a good indication of the efficacy of LEAP. If our results are positive, LEAP has the potential of benefiting about half of the eating disorder population, with remission and recovery hopefully improving as a result. Trial registration: The trial is registered with the ISRCTN registry (registration date 2020-03-25), trial ID: ISRCTN80711391. [ABSTRACT FROM AUTHOR]

Introduction: Tuberculosis (TB) is the leading infectious killer globally and new TB vaccines will be crucial to ending the epidemic. Since the introduction in 1921 of the only currently licensed TB vaccine, BCG, very few novel vaccine candidates or strategies have advanced into clinical efficacy trials. Areas covered: Recently, however, two TB vaccine efficacy trials with novel designs have reported positive results and are now driving new momentum in the field. They are the first Prevention of Infection trial, evaluating the H4:IC31 candidate or BCG revaccination in high-risk adolescents and a Prevention of Disease trial evaluating the M72/AS01E candidate in M.tuberculosis-infected, healthy adults. These trials are briefly reviewed, and lessons learned are proposed to help inform the design of future efficacy trials. The references cited were chosen by the author based on PubMed searches to provide context for the opinions expressed in this Perspective article. Expert opinion: The opportunities created by these two trials for gaining critically important knowledge are game-changing for TB vaccine development. Their results clearly establish feasibility in the relatively near term of developing novel, effective vaccines that could be crucial to ending the TB epidemic.

Background: Major Depressive Disorder (MDD) is a disabling mood disorder, profoundly affecting a large number of adolescent's quality of life. To date, no obvious treatment of choice for MDD in adolescents is available and progress in the treatment of depressed adolescents will have important public health implications. Attachment-Based Family Therapy (ABFT), as the only empirically supported family therapy model designed to treat adolescent depression, aims to repair interpersonal ruptures and rebuild an emotionally protective parent–child relationship. Objective: To study the effectiveness of ABFT compared with treatment as usual (TAU) delivered within child- and adolescent mental health services (CAMHS) to adolescents with MDD. Method: Sixty adolescents (86.7% girls), aged 13–18 years (M = 14.9, SD = 1.35), with MDD referred to two CAMHS were randomized to 16 weeks of ABFT or TAU. ABFT consisted of weekly therapy sessions (family/individual or both) according to the treatment manual. TAU was not monitored. Primary outcomes were assessed by blinded evaluators at baseline and post-treatment with the Hamilton Depression Scale (HAMD). Self-reported (Beck Depression Inventory-II, BDI-II) depressive symptoms were assessed at baseline, and after 4, 6, 8, 10,12, 14, and 16 weeks. Analyses were performed according to intent-to-treat principles. Results: At post-treatment, clinician-rated remission rates on the HAMD (5% in ABFT and 3.33% in TAU, p = 1, OR = 1.54, Fisher's exact test) and self-reported symptoms of depression on the BDI-II did not differ significantly between groups (X2[2, N = 60] = 0.06, p = 0.97). In both treatment groups participants reported significantly reduced depressive symptoms, but the majority (63.3%) of adolescents were still in the clinical range after 16 weeks of treatment. Conclusion: ABFT was not superior to TAU. Remission and response rates were low in both groups, suggesting none of the treatments were effective in treating MDD in adolescents. Findings must be viewed in the context of the study's small sample size, missing data, and implementation challenges. Continued efforts to improve treatment for MDD in outpatient clinics are warranted. Future research should examine moderators of and mechanisms for individual differences to treatment response, as well as the feasibility and cost-effectiveness of implementing treatment models which may require extensive training and expertise to yield clinically meaningful improvements in non-research settings. Trial registration Clinicaltrials.gov identifier: NCT01830088 https://clinicaltrials.gov/ct2/show/NCT01830088?term=Villab%C3%B8&draw=2&rank=1 Date of registration: April 12, 2013 [ABSTRACT FROM AUTHOR]

To rapidly evaluate the safety and efficacy of COVID-19 vaccine candidates, prioritizing vaccine trial sites in areas with high expected disease incidence can speed endpoint accrual and shorten trial duration. Mathematical and statistical forecast models can inform the process of site selection, integrating available data sources and facilitating comparisons across locations. We recommend the use of ensemble forecast modeling – combining projections from independent modeling groups – to guide investigators identifying suitable sites for COVID-19 vaccine efficacy trials. We describe an appropriate structure for this process, including minimum requirements, suggested output, and a user-friendly tool for displaying results. Importantly, we advise that this process be repeated regularly throughout the trial, to inform decisions about enrolling new participants at existing sites with waning incidence versus adding entirely new sites. These types of data-driven models can support the implementation of flexible efficacy trials tailored to the outbreak setting. [ABSTRACT FROM AUTHOR]

Purpose: High prevalence of vitamin D deficiency (VDD) justifies a cost-effective and sustainable strategy to combat VDD in the community. This study was undertaken for the first time to evaluate the efficacy of daily consumption of vitamin D fortified sunflower oil with a meal. Methods: This single-blind trial was conducted in two separate institutions: one as intervention (D-fortified sunflower oil) group (DO, n1 = 39) and the other as control (unfortified sunflower oil) group (SO, n2 = 33). Participants consumed their lunches cooked either with D-fortified or unfortified cooking sunflower oil (500 IU/30 g) for 12 weeks. Dietary, anthropometric and biochemical assessments were done for all participants before and after the intervention. Results: A total of 65 subjects from both sexes aged 32.5 ± 4 years completed the intervention period. Serum 25(OH)D showed a significant increase in DO and a decrease in SO group (8.8 ± 9.3 vs. − 7.4 ± 6.4 ng/mL, p < 0.001). The rise in serum 25(OH)D in DO group was accompanied by a significant decrease in iPTH (DO: − 10.2 ± 29.4 vs. SO: + 9.2 ± 29.5 pg/mL; p = 0.009). A significant reduction in weight (p = 0.004), BMI (p = 0.029), waist girth (p < 0.001), serum total cholesterol (p = 0.0290) and LDL-C (p = 0.010) was observed in DO, as compared with SO group. Conclusions: Cooking oil can be considered as an efficacious vehicle for mass fortification program to combat VDD. The improvement of vitamin D status may bring about betterment of certain cardiometabolic risk factors. Registration number: Clinicaltrials.gov: NCT03826654. [ABSTRACT FROM AUTHOR]

Background: The spices based dietary interventions are in lime light among the scientific community owing to their promising therapeutic perspective. The bioactive components in spices can be used to exert various health promoting functions in human body such as prompting weight loss, inhibit diet-induced obesity, hypercholesterolemia, hyperglycemia, allergies and various other maladies. In current study extraction and in vitro characterization of coriander seed (CS), black cumin seed (BCS) and fenugreek seed (FS) polyphenols was conducted for further development of dietary intervention against lipid and glycemia related abnormalities in experimental Sprague Dowley rats fed with control and different spice powder supplemented diets. Methods: Purposely, extraction of Coriander (CS), Black cumin (BCS) and Fenugreek seeds (FS) were carried out by using water and aqueous methanol (70:30 v/v). Afterwards, the resultant extracts were thoroughly investigated for their antioxidant potential through different indices like TPC, TFC, FRAP and β Carotene Bleaching Assay and ABTS. Furthermore, HPLC quantification were also conducted with special reference to thymoquinone, disogenin, chlorogenic acid, caffeic acid and kaempferol alongside in vitro pancreatic lipase inhibitory activity estimation. Bio-evaluation trial was consisting of three modules i.e. study-I (normal diet), study-II (high cholesterol diet) and study-III (high sucrose diet). Furthermore, rats were sub-divided in five groups in each module on the basis of diet provision including T0 (control), T1 (Diet containing CS), T2 (Diet containing BCS), T3 (Diet containing FS) and T4 (Diet containing CSP + BCSP + FSP). At the beginning of trial, some rats were dissected to evaluate the baseline values whilst rest of the rats was killed at the termination (56th day). Feed and drink intakes were quantified on daily bases whereas, body weight was calculated weekly. Cholesterol level, serum low density lipoproteins (LDL), high density lipoproteins (HDL), triglycerides, glucose concentration and insulin level of collected sera was measured by standard procedures. Results: The in vitro characterization showed better extraction of spices antioxidant through aqueous methanol as compared to water. Among the spices, Black cumin seed alone or in combination revealed highest antioxidant activity in T2 (BCS) followed by T4 (CS + BCS), T7 (CS + BCS + FS), T1 (CS), T6 (BCS + FS), T5 (CS + FS) and lowest in T3 (FS). Likewise, the HPLC characterization showed the presence of thymoquinone in BCS, Dosignienin FGS and chlorogenic acid, caffeic acid and kaempferol in the other treatments. Furthermore, all the treatments showed dose dependent inhibition in Pancreatic lipase activity and order of inhibition was BCS > CS + BCS > CS + BCS + FS > CS > BCS + FC > CS + FS > FS. The maximum feed intake, drink intake and weight gain was observed in T0 (control) trailed by T1, T2, T3 and T4 group in experimental study I, II and III, respectively. The resultant diet T4 enhanced the high density lipoprotein from T0 (58.58 ± 2.51) to 61.71 ± 1.62 (T4) in hypercholesterolemia rats whereas in hyperglycaemia rats the HDL was varied from 38.77 ± 1.2 to 40.02 ± 0.99 in T0 and T4, respectively. Similarly, T2 significantly lowered the low density lipoprotein from 62.53 ± 1.22 (T1) & 46.53 ± 0.99 to 54.88 ± 0.52 & 40.94 ± 1.99 (T2) in hypercholesteraemic and diabetic rats. Moreover, T4 treatment showed maximum reduction as 10.01 & 11.53% in respective studies. Conclusions: The diet prepared from the different combination of spices has been proven effective against Oxidative stress related physiological malfunctioning. [ABSTRACT FROM AUTHOR]

This field efficacy trial using aluminum phosphide tablets for controlling the valley pocket gopher was conducted on land farmed by California State Polytechnic University, Pomona, California. The treatment blocks were located in moderate to heavily infested cover crops in deciduous orchards. Each of 2 treatment blocks contained 10 study plots, as did 2 control blocks. All burrows in the treatment blocks as well as a 100-foot-wide buffer were treated by placement of 2 to 4 Fumitoxin® tablets in each of 1 to 3 probed holes. Both treatment units had a 90% decline in pocket gopher activity, judged by the open hole census method, after the first treatment, and 100% reduction after burrows missed in the first treatment were treated. All burrows in the control plots remained active throughout the entire trial. All treatment points in the study plots were flagged and 33%, including 6 burrows remaining active in the 2-day post-treatment period, were examined for proper tablet placement. The importance of proper aluminum phosphide tablet placement is discussed.

There is growing pressure to make efficacy experiments more useful. This requires attending to the twin goals of generalizing experimental results to those schools that will use the results and testing the intervention's theory of action. We show how electronic records, created naturally during the daily operation of technology-based interventions, contain the information needed to attend to these twin goals. These records allow researchers to define the population of schools considering adoption of an intervention and to plan an experiment to generalize to these schools. They also allow researchers to identify schools likely to fully implement the intervention, such that the theory of action can be properly tested. Designing experiments to address these goals involves many tradeoffs and prioritizing the different purposes of the planned experiment. We discuss these challenges, linking experimental purposes with design decisions. [ABSTRACT FROM AUTHOR]

Introduction: Tuberculosis (TB) is the leading infectious killer globally and new TB vaccines will be crucial to ending the epidemic. Since the introduction in 1921 of the only currently licensed TB vaccine, BCG, very few novel vaccine candidates or strategies have advanced into clinical efficacy trials. Areas covered: Recently, however, two TB vaccine efficacy trials with novel designs have reported positive results and are now driving new momentum in the field. They are the first Prevention of Infection trial, evaluating the H4:IC31 candidate or BCG revaccination in high-risk adolescents and a Prevention of Disease trial evaluating the M72/AS01E candidate in M.tuberculosis-infected, healthy adults. These trials are briefly reviewed, and lessons learned are proposed to help inform the design of future efficacy trials. The references cited were chosen by the author based on PubMed searches to provide context for the opinions expressed in this Perspective article. Expert opinion: The opportunities created by these two trials for gaining critically important knowledge are game-changing for TB vaccine development. Their results clearly establish feasibility in the relatively near term of developing novel, effective vaccines that could be crucial to ending the TB epidemic. [ABSTRACT FROM AUTHOR]

Objective: This report evaluates a dissonance-based group eating disorder treatment designed to be a cost-effective front-line transdiagnostic treatment that could be more widely implemented than extant treatments that are more intensive and expensive relative to a supportive mindfulness group treatment typical of that offered at colleges. Method: Young women with eating disorders (N = 84) were randomized to 8-week dissonance-based Body Project treatment (BPT) or supportive mindfulness treatment, completing diagnostic interviews and questionnaires at pretest, posttest, and 6-month follow up. Results: Regarding primary outcomes, by 6-month follow up 77% of BPT participants no longer met diagnosis for an eating disorder versus 60% of supportive mindfulness participants (relative risk ratio = 2.22; 95% Cl [1.01, 4.93]), though groups did not differ on eating disorder symptom change. Regarding secondary outcomes, BPT versus supportive mindfulness participants showed significantly lower dissonance about affirming the thin ideal at posttest and 6-month follow up (d = .38 and .32), body dissatisfaction at posttest and 6-month follow up (d = .62 and .62), negative affect at posttest and 6-month follow up (d = .49 and .48), and functional impairment (d = .36) at 6-month follow up; differences in thin-ideal internalization and abstinence from binge eating and compensatory behaviors were not significant. Conclusions: Whereas both treatments appeared effective, BPT produced larger effects and significantly greater remission of eating disorder diagnoses than a credible alternative treatment, which is very rare for trials that have compared active eating disorder treatments. Results suggest it would be useful to refine BPT and conduct target engagement research and efficacy trials. [ABSTRACT FROM AUTHOR]

‘Draper’ northern highbush blueberry (Vaccinium corymbosum L.) is a widely-planted mid-season cultivar with excellent fruit quality. Under the climatic conditions of Southwestern British Columbia, Canada, and Northwestern Washington, USA, it expresses a physiological disorder causing spontaneous green fruit drop (GFD) of up to half of the developing crop just prior to onset of the fruit coloring phenophase. Reduction of economic losses due to GFD required identification of the cause of this disorder and development of an agronomic solution that would reduce fruit drop. In 2014, two initial experiments were conducted to compare three foliar Ca products under a range of N fertilization rates. In 2015 and 2016, three locations were used in a first step to optimizing rates and timings of foliar Ca application. Initial experiments determined that higher N fertilization rates exacerbate GFD but that foliar Ca corrects the condition. Multi-site, multi-year trials identified key rates and timings for foliar Ca application to provide an agronomic solution for commercial growers. These trials identified an acute fruit Ca deficiency as the cause of GFD, and that foliar calcium applied frequently at high concentration from mid-bloom onward can be effective in reducing GFD, often to negligible levels. This condition has now been reported in several production regions around the world.

Increased crash incidence following deployment and veterans' reports of driving difficulty spurred traffic safety research for this population. We conducted an interim analysis on the efficacy of a simulator-based occupational therapy driving intervention (OT-DI) compared with traffic safety education (TSE) in a randomized controlled trial. During baseline and post-testing, OT-Driver Rehabilitation Specialists and one OT-Certified Driver Rehabilitation Specialist measured driving performance errors on a DriveSafety CDS-250 high-fidelity simulator. The intervention group (n = 13) received three OT-DI sessions addressing driving errors and visual-search retraining. The control group (n = 13) received three TSE sessions addressing personal factors and defensive driving. Based on Wilcoxon rank-sum analysis, the OT-DI group's errors were significantly reduced when comparing baseline with Post-Test 1 (p < .0001) and comparing the OT-DI group with the TSE group at Post-Test 1 (p = .01). These findings provide support for the efficacy of the OT-DI and set the stage for a future effectiveness study. [ABSTRACT FROM AUTHOR]

EightCylindropuntiaspecies have naturalised in Australia and pose serious economic, environmental and social impacts. The host range of four additional biotypes ofD. tomentosusfrom southern USA was investigated. Feeding and development were restricted to the genusCylindropuntia. However, they showed differences in specificity within this genus and some biotypes discriminated between the provenances ofCylindropuntia roseaandCylindropuntia tunicata. Efficacy trials were conducted to determine whether populations of each biotype could be sustained on the naturalisedCylindropuntiaspecies and if these populations could retard the growth or kill these plants. The ‘acanthocarpa’ biotype offers potential control ofC. rosea(Lorne Station), while the ‘cylindropuntia sp.’ biotype shows great potential to controlC. rosea(Grawin). The ‘cylindropuntia sp.’ biotype also had a high impact onCylindropuntia kleiniaeandCylindropuntia imbricata, and a moderate impact onCylindropuntia leptocaulisandCylindropuntia prolifera. The ‘acanthocarpa × echinocarpa’ biotype had its greatest impact onC. tunicata(Grawin), killing this plant in 18 weeks. A fourth biotype, ‘leptocaulis’, was damaging to some species, but was less effective than the other biotypes.Cylindropuntia spinosioris the only naturalised species in Australia where no effective biocontrol agent has been found. [ABSTRACT FROM PUBLISHER]

Research has consistently linked social–emotional skills to important educational and life outcomes. Many children begin their school careers, however, without the requisite social and emotional skills that facilitate learning, which has prompted schools nationwide to adopt specific curricula to teach students the social–emotional skills that enable them to maintain optimal engagement in the learning process. Second Step ® is one of the most widely disseminated social–emotional learning (SEL) programs; however, its newly revised version has never been empirically evaluated. The purpose of this study was to conduct a randomized controlled trial investigating the impact of the 4th Edition Second Step ® on social–behavioral outcomes over a 1-year period when combined with a brief training on proactive classroom management. Participants were kindergarten to 2nd grade students in 61 schools (321 teachers, 7300 students) across six school districts. Hierarchical models (time × condition) suggest that the program had few main effects from teacher-reported social and behavioral indices, with small effect sizes. The majority of significant findings were moderated effects, with 8 out of 11 outcome variables indicating the intervention-produced significant improvements in social–emotional competence and behavior for children who started the school year with skill deficits relative to their peers. All the significant findings were based on teacher-report data highlighting a need for replication using other informants and sources of data. Findings provide program validation and have implications for understanding the reach of SEL programs. [ABSTRACT FROM AUTHOR]

This study examined the efficacy of a curriculum-based intervention for high school science students. Specifically, the intervention was two years of research-based, multidisciplinary curriculum materials for science supported by comprehensive professional development for teachers that focused on those materials. A modest positive effect was detected when comparing outcomes from this intervention to those of business-as-usual materials and professional development. However, this effect was typical for interventions at this grade span that are tested using a state achievement test. Tests of mediation suggest a large treatment effect on teachers and in turn a strong effect of teacher practice on student achievement—reinforcing the hypothesized key role of teacher practice. Tests of moderation indicate no significant treatment by demographic interactions. [ABSTRACT FROM AUTHOR]

The host range of two newly imported biotypes ofDactylopius tomentosusand their potential as biological control agents ofCylindropuntiaspp. were investigated. A third biotype (‘imbricata’) ofD. tomentosuspreviously released in Australia to controlC. imbricatawas also screened to determine if it will feed on other species ofCylindropuntiaoccurring in Australia. Efficacy trials were conducted to evaluate the ability of the biotypes to retard the growth or kill those plant species supporting development of four or more individuals in the host test trials. The host range of the three biotypes ofD. tomentosuswas restricted to the genusCylindropuntia.However, the biotypes showed varying degrees of specificity within this genus. The ‘imbricata’ biotype was the only biotype to develop on AustralianC. roseaprovenances, albeit with a range of developmental success on allC. roseaprovenances tested. The Spanish provenance supported the highest development success followed by Grawin (NSW), Lorne Station (NSW) while the least preferred was the Mexican provenance. The ‘rosea’ and ‘cholla’ biotypes were unsuitable candidates to controlC. roseain Australia. However, the efficacy trials showed that the ‘cholla’ biotype had a high impact on four of the eight naturalisedCylindropuntiaspecies in Australia. This biotype established rapidly and the sustained feeding of one fecund female and her progeny killed potted plants ofC. imbricataandC. fulgidaat week 18. This biotype has the potential to be an effective agent againstC. fulgida,C. imbricata,C. kleiniaeandC. tunicataand, as a consequence, an application seeking its release in Australia has been lodged. [ABSTRACT FROM PUBLISHER]

The authors conducted a pilot trial of a new dissonance-based group eating disorder treatment designed to be a cost-effective front-line transdiagnostic treatment that could be more widely disseminated than extant individual or family treatments that are more expensive and difficult to deliver. Young women with a DSM-5 eating disorder ( N = 72) were randomized to an 8-week dissonance-based Counter Attitudinal Therapy group treatment or a usual care control condition, completing diagnostic interviews and questionnaires at pre, post, and 2-month follow-up. Intent-to-treat analyses revealed that intervention participants showed greater reductions in outcomes than usual care controls in a multivariate multilevel model (χ 2 [6] = 34.1, p < .001), producing large effects for thin-ideal internalization ( d = .79), body dissatisfaction ( d = 1.14), and blinded interview-assessed eating disorder symptoms ( d = .95), and medium effects for dissonance regarding perpetuating the thin ideal ( d = .65) and negative affect ( d = .55). Midway through this pilot we refined engagement procedures, which was associated with increased effect sizes (e.g., the d for eating disorder symptoms increased from .51 to 2.30). This new group treatment produced large reductions in eating disorder symptoms, which is encouraging because it requires about 1/20th the therapist time necessary for extant individual and family treatments, and has the potential to provide a cost-effective and efficacious approach to reaching the majority of individuals with eating disorders who do not presently received treatment. [ABSTRACT FROM AUTHOR]

Indoxacarb gel bait was evaluated for its efficacy in the laboratory and field against American cockroaches, Periplaneta americana (L.), and German cockroaches, Blattella germanica (L.). Advion 0.6% indoxacarb gel bait was toxic to both P. americana and B. germanica. There were no significant differences in the LT50 (h) values for treatment levels of 0.25 g, 0.5 g, and 1.0 g gel applied against P. americana, whereas gel applied at 0.5 g to B. germanica had a significantly greater LT50 (h) in the laboratory than the gel treatments on P. americana. The LT50 for both cockroach species ranged from 40.65 to 145.60 h. There was no control mortality in the laboratory bioassays. In the field, 55 houses were treated with 0.5 g of 6-8 spots of indoxacarb gel bait per kitchen of two or three bedroom bungalows from three Local Government Areas of Lagos State, comprising Sumiere (22), Alimosho (12), and Shomolu (21). Mean reduction in cockroach populations varied from location to location based on the level of infestations. Percentage reductions in the indoxacarb gel-treated units ranged from 3.5% at 1 d after treatment to 99.8% at 14 d at Sumiere, while reductions ranged from 8.9% at 1 d after treatment to 99.7% at 14 d at Shomolu; a similar trend was observed for Alimosho. Indoxacarb gel bait was highly effective in the control of cockroaches. [ABSTRACT FROM AUTHOR]

The article focuses on the evaluation of treatments for posttraumatic stress disorder (PTSD) as applied to Narrative Exposure Therapy (NET). Topics discussed include various relief interventions conducted in low and middle income countries (LMICs), efficacy of NET with the children survivors of the tsunami in Sri Lanka in 2004, and the impact of randomised controlled efficacy trials (RCTs).

Therapist-guided internet-based cognitive behavior therapy (ICBT) has been tested in numerous controlled trials conducted in research settings. It is now established that this novel treatment format works for a range of clinical conditions. It is less well known if the promising results from efficacy studies can be transferred to routine clinical practice. In this paper we review the evidence from effectiveness studies and highlight challenges when implementing ICBT. Following literature searches we identified 4 controlled trials and 8 open studies, involving a total of 3,888 patients. There is now an increasing number of effectiveness studies on ICBT with studies on panic disorder, social anxiety disorder, generalized anxiety disorder, post-traumatic stress disorder, depression, tinnitus, and irritable bowel syndrome. All indicate that it is possible to transfer ICBT to clinical practice with sustained effects and moderate to large effect sizes. However, it is not clear which model to use for service delivery, and more work remains to be done on dissemination of ICBT. Moreover, the knowledge about outcome predictors from controlled efficacy trials is probably less relevant, and studies with large clinically representative samples are needed to investigate for which patients ICBT is suitable. In this work existing data could be combined and reanalyzed to study predictors of outcome. [ABSTRACT FROM AUTHOR]

This study examined implications of the economic downturn that began in December 2007 for the Community Youth Development Study (CYDS), a longitudinal randomized controlled trial of the Communities That Care (CTC) prevention system. The downturn had the potential to affect the internal validity of the CYDS research design and implementation of science-based prevention in study communities. We used archival economic indicators and community key leader reports of economic conditions to assess the extent of the economic downturn in CYDS communities and potential internal validity threats. We also examined whether stronger economic downturn effects were associated with a decline in science-based prevention implementation. Economic indicators suggested the downturn affected CYDS communities to different degrees. We found no evidence of systematic differences in downturn effects in CTC compared to control communities that would threaten internal validity of the randomized trial. The Community Economic Problems scale was a reliable measure of community economic conditions, and it showed criterion validity in relation to several objective economic indicators. CTC coalitions continued to implement science-based prevention to a significantly greater degree than control coalitions 2 years after the downturn began. However, CTC implementation levels declined to some extent as unemployment, the percentage of students qualifying for free lunch, and community economic problems worsened. Control coalition implementation levels were not related to economic conditions before or after the downturn, but mean implementation levels of science-based prevention were also relatively low in both periods. [ABSTRACT FROM AUTHOR]

Introduction: A video to promote parents' appreciation of young children's risk of injury and need for active supervision was recently developed (Morrongiello, Zdzieborski, Sandomierski, & Lasenby-Lessard, 2009). Integrating this video with tailored activities resulted in the Supervising for Home Safety program. The current randomized, controlled trial evaluated the efficacy of this program for increasing parental appraisals of child-injury risk and the need to actively supervise 2- through 5-year-old children. Method: Parents were recruited throughout the community and randomly assigned to either intervention (content focused on child-injury risks and supervision needs) or control (content focused on child nutrition and exercise) groups, with these balanced for child sex and age. Pre- and postintervention measures of parental appraisals of child-injury risk (vulnerability for injury, potential injury severity, preventability of injury) and supervision (value of active supervision, self-efficacy for actively supervising) were taken. Results: Following exposure to the intervention, appraisals of children's injury risk and parents' need to actively supervise significantly increased in the intervention group but not the control group, and all effects, except change in vulnerability appraisal, persisted for 12 months after exposure to the intervention program. Additional analyses were conducted to explore barriers that parents identified to closely supervising and solutions they suggested to address barriers. Conclusions: The Supervising for Home Safety program produced the desired effects on parental appraisals. It holds promise as a program that may improve parents' supervision practices. [ABSTRACT FROM AUTHOR]

Objective - To determine clinical efficacy of the Crotalidae polyvalent immune Fab (ovine) antivenom (OPCA) against progressive crotalid envenomation in the dog as reflected in stabilization or improvement of snakebite severity scores (SSS). Additionally, due to the potential decreased half-life of the Fab antibodies in dogs we compared SSS between dogs receiving 2 different dosing regimes. Design - Prospective, clinical trial. Setting - Five veterinary emergency and critical care facilities. Animals - One hundred and fifteen client-owned Crotalid (rattlesnake) snake bitten dogs in whom worsening of the envenomation syndrome was observed before OPCA treatment. Interventions - In a multicenter randomized clinical trial a single dose (1 vial) of OPCA alone was compared with 2 doses (1/2 vial each) administered 6 hours apart. Standard supportive care was provided in all cases. Measurements and Main Results - Data were available for 115 patients, 9 of which were fatalities. All patients' clinical condition was documented with a standardized SSS system accounting for each major body system. Each fatality received maximum severity scores of 20. The mean severity score of the 115 patients decreased from 4.19 to 3.29 points and there was no difference between the 2 treatment groups. The mean severity score of the 107 patients without fatalities decreased from 4.16 to 2.15. Antivenin-related acute reactions occurred in 6 dogs (6%), and no serum sickness occurred within the 95 cases contacted at the 2-week posttreatment follow-up. Conclusions - In the first randomized trial in dogs of antivenin in the United States, OPCA effectively stabilized or terminated venom effects. There were no statistical differences detected between treatment groups within the study time frame. [ABSTRACT FROM AUTHOR]

Abstract: Advances in molecular and cellular biology as well as biotechnology led to definition of a group of drugs referred to as medicinal products of advanced technologies. It includes gene therapy products, somatic cell therapeutics and tissue engineering. Therapeutic cancer vaccines including whole cell tumor cells vaccines or gene modified whole cells belong to somatic therapeutics and/or gene therapy products category. The drug development is a multistep complex process. It comprises of two phases: preclinical and clinical. Guidelines on preclinical testing of cell based immunotherapy medicinal products have been defined by regulatory agencies and are available. However, clinical testing of therapeutic cancer vaccines is still under debate. It presents a serious problem since recently clinical efficacy of the number of cancer vaccines has been demonstrated that focused a lot of public attention. In general clinical testing in the current form is very expensive, time consuming and poorly designed what may lead to overlooking of products clinically beneficial for patients. Accordingly regulatory authorities and researches including Cancer Vaccine Clinical Trial Working Group proposed three regulatory solutions to facilitate clinical development of cancer vaccines: cost-recovery program, conditional marketing authorization, and a new development paradigm. Paradigm includes a model in which cancer vaccines are investigated in two types of clinical trials: proof-of-principle and efficacy. The proof-of-principle trial objectives are: safety; dose selection and schedule of vaccination; and demonstration of proof-of-principle. Efficacy trials are randomized clinical trials with objectives of demonstrating clinical benefit either directly or through a surrogate. The clinical end points are still under debate. [Copyright &y& Elsevier]

Abstract: Studies were conducted on the efficacy of Olyset nets—a long-lasting insecticidal net (LLIN) factory treated with 2% (w/w) permethrin on malaria transmission in an area under the influence of pyrethroid susceptible vector species Anopheles culicifacies and A. fluviatilis in Sundargarh District, Orissa, India. The study area comprised 22 villages that were randomized into three clusters and designated as Olyset net, untreated net, and no net area. Malaria incidence in the study population was measured through longitudinal active surveillance at fortnightly intervals. There was a reduction of 65–70% in malaria incidence in Olyset net area as compared to the control areas. The attack rate of Plasmodium falciparum or number of episodes per person per year in different age groups also showed significant reduction in Olyset net area as compared to untreated net and no net areas. Cross-sectional point prevalence surveys showed 45.7% reduction of malaria prevalence in Olyset net users, whereas there was an increase of 33.3% and 51% in untreated net and no net villages respectively. The compliance rate of Olyset net usage in the study population was 80–98% during different months, whereas it was between 70% and 90% for untreated nets. There were minimal complains of skin irritation (4%), itching (8%) and eye irritation (1.2%). However, these effects were only transitory in nature lasting for few hours of the first usage. Olyset nets also provided collateral benefits in terms of relief not only from mosquitoes and malaria but also from other household pests such as head lice, bed bugs, cockroaches, ants and houseflies. The Olyset nets were found to be safe to humans as no adverse event was recorded in the net users that can be attributed to the use of net. The study showed that Olyset nets are effective personal protection tool that can be used in a community based intervention programme. [Copyright &y& Elsevier]