The effect of curcumin and zinc co‐supplementation on glycemic parameters in overweight or obese prediabetic subjects: A phase 2 randomized, placebo‐controlled trial with a multi‐arm, parallel‐group design

2021 ◽  
Author(s):  
Majid Karandish ◽  
Hassan Mozaffari‐khosravi ◽  
Seyed Mohammad Mohammadi ◽  
Bahman Cheraghian ◽  
Maryam Azhdari
Keyword(s):  
Controlled Trial ◽  
Phase 2 ◽  
Group Design ◽  
Parallel Group Design ◽  
Parallel Group

scholarly journals A National Quality Improvement Collaborative for the clinical use of outcome measurement in specialised mental healthcare: Results from a parallel group design and a nested cluster randomised controlled trial

BJPsych Open ◽  
2017 ◽  
Vol 3 (3) ◽  
pp. 106-112 ◽  
Author(s):  
Margot J. Metz ◽  
Marjolein A. Veerbeek ◽  
Gerdien C. Franx ◽  
Christina M. van der Feltz-Cornelis ◽  
Edwin de Beurs ◽  
...  
Keyword(s):  
Outcome Measurement ◽  
Controlled Trial ◽  
Mental Healthcare ◽  
Cluster Randomised Controlled Trial ◽  
Group Design ◽  
Cluster Randomised ◽  
Parallel Group Design ◽  
Parallel Group ◽  
National Quality ◽  
Randomised Controlled

BackgroundAlthough the importance and advantages of measurement-based care in mental healthcare are well established, implementation in daily practice is complex and far from optimal.AimsTo accelerate the implementation of outcome measurement in routine clinical practice, a government-sponsored National Quality Improvement Collaborative was initiated in Dutch-specialised mental healthcare.MethodTo investigate the effects of this initiative, we combined a matched-pair parallel group design (21 teams) with a cluster randomised controlled trial (RCT) (6 teams). At the beginning and end, the primary outcome ‘actual use and perceived clinical utility of outcome measurement’ was assessed.ResultsIn both designs, intervention teams demonstrated a significant higher level of implementation of outcome measurement than control teams. Overall effects were large (parallel group d=0.99; RCT d=1.25).ConclusionsThe National Collaborative successfully improved the use of outcome measurement in routine clinical practice.

scholarly journals Eight Weeks ofCosmos caudatus(Ulam Raja) Supplementation Improves Glycemic Status in Patients with Type 2 Diabetes: A Randomized Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-7
Author(s):  
Shi-Hui Cheng ◽  
Amin Ismail ◽  
Joseph Anthony ◽  
Ooi Chuan Ng ◽  
Azizah Abdul Hamid ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Serum Insulin ◽  
Controlled Trial ◽  
Glycemic Status ◽  
Group Design ◽  
Randomized Controlled ◽  
Parallel Group Design ◽  
Parallel Group

Objectives. Optimizing glycemic control is crucial to prevent type 2 diabetes related complications.Cosmos caudatusis reported to have promising effect in improving plasma blood glucose in an animal model. However, its impact on human remains ambiguous. This study was carried out to evaluate the effectiveness ofC. caudatuson glycemic status in patients with type 2 diabetes.Materials and Methods. In this randomized controlled trial with two-arm parallel-group design, a total of 101 subjects with type 2 diabetes were randomly allocated to diabetic-ulam or diabetic controls for eight weeks. Subjects in diabetic-ulam group consumed 15 g ofC. caudatusdaily for eight weeks while diabetic controls abstained from takingC. caudatus.Both groups received the standard lifestyle advice.Results. After 8 weeks of supplementation,C. caudatussignificantly reduced serum insulin (−1.16 versus +3.91), reduced HOMA-IR (−1.09 versus +1.34), and increased QUICKI (+0.05 versus −0.03) in diabetic-ulam group compared with the diabetic controls. HbA1C level was improved although it is not statistically significant (−0.76% versus −0.37%).C. caudatuswas safe to consume.Conclusions.C. caudatussupplementation significantly improves insulin resistance and insulin sensitivity in patients with type 2 diabetes.

scholarly journals Does fMRI neurofeedback in the context of stress influence mood and arousal? A randomised controlled trial with parallel group design

F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 1031
Author(s):  
Angelo Belardi ◽  
Jong-Hwan Lee ◽  
Hyun-Chul Kim ◽  
Esther Stalujanis ◽  
Eun Kyung Jung ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Stroop Task ◽  
Controlled Trial ◽  
Anterior Cingulate ◽  
Group Design ◽  
Parallel Group Design ◽  
Parallel Group ◽  
Fmri Session ◽  
Randomised Controlled ◽  
Subjective Arousal

Background: Stress-related mental and physical health issues burden modern societies. New treatment opportunities could help to lessen long-term detrimental consequences of stress. Objective: To investigate whether real-time functional magnetic resonance imaging neurofeedback (rtfMRInf), aimed at modulating brain activity associated with a stressor, affects subjective mood and arousal. Methods: In total, 30 males participated in a randomised controlled trial with parallel-group design. rtfMRInf was the intervention, sham-neurofeedback the control condition, and the Stroop task the stressor. We instructed participants to modulate their stress response to the Stroop task via feedback from their anterior cingulate cortex and their insular cortex, concomitantly applying mental strategies. We assessed mood with the Multidimensional Mood State Questionnaire (dimensions: good/bad, GB; awake/tired, AT; and calm/nervous, CN), and subjective arousal with Self-Assessment Manikins (SAM). Results: We found significantly higher subjective arousal after neurofeedback phases in the experimental condition as compared to the control condition [t(26.6) = −2.216, 95%CI [−2.188,−0.083], p = 0.035; t(27.9) = −3.252, 95%CI [−2.685,−0.609], p = 0.003], but no significant differences between the conditions regarding mood [GB: b = 0.4, 95%CI [−0.67, 1.47], p = 0.467; AT: b = 0.769, 95%CI [−0.319, 1.857], p = 0.177; CN: b = 0.5, 95%CI [−0.53, 1.53], p = 0.352]. In both conditions, there was significantly worse and more tired mood after the fMRI session as compared to before [GB:b = −0.77, 95% CI [−1.31, 0.23], p = 0.009; AT: b = −0.652, 95%CI [−1.116,−0.187], p = 0.01]. Conclusions: Findings indicate that rtfMRInf led to higher arousal, which may counteract the aim to reduce stress responses. Whether the multitasking situation has triggered this neurofeedback-related arousal – and how to circumvent it – asks for further study. Trial registration: NCT01921088, ClinicalTrials.gov, 13th August 2013.

scholarly journals Does fMRI neurofeedback in the context of stress influence mood and arousal? A randomised controlled trial with parallel group design

F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 1031
Author(s):  
Angelo Belardi ◽  
Jong-Hwan Lee ◽  
Hyun-Chul Kim ◽  
Esther Stalujanis ◽  
Eun Kyung Jung ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Stroop Task ◽  
Controlled Trial ◽  
Anterior Cingulate ◽  
Group Design ◽  
Parallel Group Design ◽  
Parallel Group ◽  
Fmri Session ◽  
Randomised Controlled ◽  
Subjective Arousal

Background: Stress-related mental and physical health issues burden modern societies. New treatment opportunities could help to lessen long-term detrimental consequences of stress. Objective: To investigate whether real-time functional magnetic resonance imaging neurofeedback (rtfMRInf), aimed at modulating brain activity associated with a stressor, affects subjective mood and arousal. Methods: In total, 30 males participated in a randomised controlled trial with parallel-group design. rtfMRInf was the intervention, sham-neurofeedback the control condition, and the Stroop task the stressor. We instructed participants to modulate their stress response to the Stroop task via feedback from their anterior cingulate cortex and their insular cortex, concomitantly applying mental strategies. We assessed mood with the Multidimensional Mood State Questionnaire (dimensions: good/bad, GB; awake/tired, AT; and calm/nervous, CN), and subjective arousal with Self-Assessment Manikins (SAM). Results: We found significantly higher subjective arousal after neurofeedback phases in the experimental condition as compared to the control condition [t(26.6) = −2.216, 95%CI [−2.188,−0.083], p = 0.035; t(27.9) = −3.252, 95%CI [−2.685,−0.609], p = 0.003], but no significant differences between the conditions regarding mood [GB: b = 0.4, 95%CI [−0.67, 1.47], p = 0.467; AT: b = 0.769, 95%CI [−0.319, 1.857], p = 0.177; CN: b = 0.5, 95%CI [−0.53, 1.53], p = 0.352]. In both conditions, there was significantly worse and more tired mood after the fMRI session as compared to before [GB:b = −0.77, 95% CI [−1.31, 0.23], p = 0.009; AT: b = −0.652, 95%CI [−1.116,−0.187], p = 0.01]. Conclusions: Findings indicate that rtfMRInf led to higher arousal, which may counteract the aim to reduce stress responses. Whether the multitasking situation has triggered this neurofeedback-related arousal – and how to circumvent it – asks for further study. Trial registration: NCT01921088, ClinicalTrials.gov, 13th August 2013.

A Clinical Study of Quazepam in Hospitalized Patients with Insomnia

1981 ◽  
Vol 9 (4) ◽  
pp. 288-291 ◽  
Author(s):  
Hans K Uhthoff ◽  
Jacques A Brunet ◽  
Anand Aggerwal ◽  
Raymond Varin
Keyword(s):  
Clinical Study ◽  
Sleep Quality ◽  
Quality Index ◽  
Adverse Reactions ◽  
Activity Index ◽  
Global Evaluation ◽  
Group Design ◽  
Parallel Group Design ◽  
Parallel Group ◽  
Hypnotic Activity

The efficacy of quazepam (Sch-16134) 15 mg capsules as a hypnotic has been compared with that of placebo in a 9-day study, using a parallel-group design. The physician's global evaluation numerically favoured quazepam 63% (nineteen of thirty) over placebo 50% (fifteen of thirty). Furthermore, it demonstrated greater improvement in Hypnotic Activity Index and Sleep Quality Index from baseline scores, and caused no adverse reactions.

scholarly journals Improving Attitudes to Volunteering Among Older Adults: A Randomized Trial Approach

2019 ◽  
Vol 42 (2) ◽  
pp. 51-61 ◽  
Author(s):  
Michelle I. Jongenelis ◽  
Ben Jackson ◽  
Jeni Warburton ◽  
Robert U. Newton ◽  
Simone Pettigrew
Keyword(s):  
Older Adults ◽  
Social Connectedness ◽  
Healthy Aging ◽  
Social Needs ◽  
Volunteer Work ◽  
Group Design ◽  
Perceptions And Attitudes ◽  
Parallel Group Design ◽  
Parallel Group ◽  
Negative Perceptions

Promoting engagement in formal volunteering represents a potential means of facilitating healthy aging. Given reluctance to participate in volunteering has been partially attributed to negative perceptions of various aspects of this activity, this study assessed whether trialing volunteering can improve perceptions among older people. Using a parallel-group design, Australians aged 60+ years ( n = 445) were randomly assigned to one of two conditions, one in which they were encouraged to trial volunteering and one in which they were asked to continue their usual activities. Perceptions and attitudes among those in the volunteering condition became significantly more favorable over 6 months relative to those in the control condition, with this change predicted by several aspects of the volunteering experience (e.g., acquisition of skills, increased social connectedness). Providing access to roles that cater to the learning and social needs of older adults appears to be important for improving attitudes toward engaging in volunteer work.

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