scholarly journals A Serum Analysis before and after Antidepressant Treatment in Major Depression: A Pilot Study

2015 ◽  
Vol 6 ◽  
pp. CMPsy.S20765
Author(s):  
Murielle Girard ◽  
Karine Vuilliers-Devillers ◽  
Emilie Pinault ◽  
Barbara Bessette ◽  
Brigitte Plansont ◽  
...  
Keyword(s):  
Pilot Study ◽  
Clinical Improvement ◽  
Rating Scale ◽  
Serum Proteins ◽  
Antidepressant Treatment ◽  
Small Sample Size ◽  
Two Dimensions ◽  
Small Sample ◽  
Complement C3 ◽  
Serum Samples

We investigated the serum protein profiles of subjects with major depressive disorder (MDD), with (n = 4) and without clinical improvement (n = 4), at the initiation of antidepressant treatment (venlafaxine) (T0) and 4 weeks later (T28), by difference gel electrophoresis in two dimensions (2D-DIGE) and mass spectrometry. The nine proteins displaying differences in composition between the two time points in the group with clinical improvement between T0 and T28 included gelsolin, clusterin, and the activated fragment of complement C3 (C3a). We then analyzed serum samples from MDD subjects receiving different antidepressants between T0 and T28. Subjects were classified into two groups, with (n = 17) or without (n = 14) clinical improvement (>50% decrease in baseline Hamilton Depression Rating Scale score), at T28. Clusterin levels did not differ between groups at either time point. Gelsolin and C3a levels differed between T0 and T28 only in the group presenting clinical improvement. A comparison with serum samples from controls suggested that the levels of these two proteins changed during MDD and were potentially modified after successful antidepressant treatment. Despite the small sample size, the results of this pilot study suggest that several changes in the expression of some serum proteins occur in association with the clinical relevance of the treatment, and indicate changes to general pathways requiring further study.

Benefits of EEG-Neurofeedback on the Modulation of Impulsivity in a Sample of Cocaine and Heroin Long-Term Abstinent Inmates: A Pilot Study

2020 ◽  
Vol 64 (12) ◽  
pp. 1275-1298
Author(s):  
M. Corominas-Roso ◽  
I. Ibern ◽  
M. Capdevila ◽  
R. Ramon ◽  
C. Roncero ◽  
...  
Keyword(s):  
Pilot Study ◽  
Clinical Improvement ◽  
Rating Scale ◽  
Treated Group ◽  
Small Sample ◽  
Anxiety And Depression ◽  
Control Group ◽  
Potential Range ◽  
Significant Clinical Improvement

The aim of this pilot study was to assess whether neurofeedback (NFB) can be useful in the treatment of impulsive behavior in long-term abstinent cocaine and heroin addicts. A single-blind sham-controlled NFB protocol was carried out to assess the effects of NFB on impulsivity in 20 (10 + 10) cocaine and heroin long-term abstinent addicts ( Diagnostic and Statistical Manual of Mental Disorders [4th ed., text rev.; DSM-IV-TR]). Psychotic and neurologic diseases were excluded. Participants underwent 40 NFB sessions based on the very slow cortical potential range. Inhibitory deficits were specifically addressed through right and left prefrontal training. Clinical improvement was measured with Likert-type scales, the Hamilton Depression Rating Scale, and the State–Trait Anxiety Inventory, and impulsivity was assessed using the Barratt Impulsiveness Scale and the Continuous Performance Test. Although the results are preliminary due to the small sample size, the NFB-treated group showed a significant clinical improvement, including symptoms of anxiety and depression, with two differentiated time periods. No significant clinical improvement was found in the control group. A significant decrease in the post- versus pre-treatment measures of global impulsivity, nonplanning impulsivity, and error commission measures was found in the NFB-treated group; effect size ( dKorr) in the pre–post control design was moderate. No significant change was found in the control group. Despite the limitations of this study, the results suggest that NFB is better than placebo in improving impulsivity and clinical symptoms of anxiety and depression in long-term abstinent cocaine- and heroin-dependent individuals.

scholarly journals Effects of Magnesium Supplementation on Unipolar Depression: A Placebo-Controlled Study and Review of the Importance of Dosing and Magnesium Status in the Therapeutic Response

Nutrients ◽  
2018 ◽  
Vol 10 (8) ◽  
pp. 1014 ◽  
Author(s):  
Beata Ryszewska-Pokraśniewicz ◽  
Anna Mach ◽  
Michał Skalski ◽  
Piotr Januszko ◽  
Zbigniew Wawrzyniak ◽  
...  
Keyword(s):  
Rating Scale ◽  
Antidepressant Treatment ◽  
Small Sample Size ◽  
Serum Magnesium ◽  
Small Sample ◽  
Controlled Study ◽  
Antidepressant Effect ◽  
Double Blind Study ◽  
Magnesium Ions ◽  
Lower Baseline

Animal studies using tests and models have demonstrated that magnesium exerts an antidepressant effect. The literature contains few studies in humans involving attempts to augment antidepressant therapy with magnesium ions. The purpose of our study was to assess the efficacy and safety of antidepressant treatment, in combination with magnesium ions. A total of 37 participants with recurrent depressive disorder who developed a depressive episode were included in this study. As part of this double-blind study, treatment with the antidepressant fluoxetine was accompanied with either magnesium ions (120 mg/day as magnesium aspartate) or placebo. During an 8-week treatment period, each patient was monitored for any clinical abnormalities. Moreover, serum fluoxetine and magnesium levels were measured, and pharmaco-electroencephalography was performed. The fluoxetine + magnesium and fluoxetine + placebo groups showed no significant differences in either Hamilton Depression Rating Scale (HDRS) scores or serum magnesium levels at any stage of treatment. Multivariate statistical analysis of the whole investigated group showed that the following parameters increased the odds of effective treatment: lower baseline HDRS scores, female gender, smoking, and treatment augmentation with magnesium. The parameters that increased the odds of remission were lower baseline HDRS scores, shorter history of disease, the presence of antidepressant-induced changes in the pharmaco-EEG profile at 6 h after treatment, and the fact of receiving treatment augmented with magnesium ions. The limitation of this study is a small sample size.

scholarly journals The Symbiotic Mutualism between Co-Creation and Entrepreneurship

2021 ◽  
Vol 13 (11) ◽  
pp. 6285
Author(s):  
Sandra Misiak-Kwit ◽  
Małgorzata Wiścicka-Fernando ◽  
Kelaniyage Shihan Dilruk Fernando
Keyword(s):  
Pilot Study ◽  
Small Sample Size ◽  
Strong Association ◽  
Sampling Technique ◽  
Small Sample ◽  
Entrepreneurial Intentions ◽  
Added Value ◽  
Primary Data ◽  
Exploratory Research ◽  
Symbiotic Mutualism

In this manuscript, the authors aim to explore firstly the association between entrepreneurial mindset and co-creation experience, secondly the association between co-creation experience and entrepreneurial intentions, and thirdly the association between entrepreneurial mindset and entrepreneurial intentions within the sustainability context. In this paper, the authors present the results of the pilot study. Primary data were collected from 500 university students from China, Georgia, Poland, Romania, and Sri Lanka by using a convenient sampling technique, and a literature review was the primary method of the concept development. The authors selected the above-mentioned countries to collect primary data by using a convenient sampling technique based on accessibility; they also visited all analysed countries in order to conduct the pilot survey personally. Descriptive statistics and the Spearman’s rank correlation coefficient were applied as primary statistical methods. The findings reveal that there is a very strong association between co-creation experience and entrepreneurial intentions, a very weak negative association between entrepreneurial mindset and co-creation experience, and, surprisingly, a weak association between entrepreneurial mindset and entrepreneurial intentions. The added value of the conducted pilot research involves filling in a gap regarding the relationship between experience and the subjective norm. In the presented pilot research, co-creation experience was compared with not only entrepreneurial mindset but with entrepreneurial intentions as well. An additional value of this exploratory research is compiling an international comparison. The main contribution of this pilot study is examining the symbiotic mutualism between co-creation and entrepreneurship. Among many platforms of associations, the following can be differentiated: creativity, innovativeness, openness, engagement, awareness, motivation, trust (level of social capital), and recognizing the significance of social and sustainable development objectives. Due to the small sample size, the results cannot be generalised. Results refer only to the respondents. However, the findings of the pilot study are the basis for further research studies on symbiotic mutualism between entrepreneurship and co-creation.

scholarly journals Blinding in electric current stimulation in subacute neglect patients with current densities of 0.8 A/m2: a cross-over pilot study

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Anna Gorsler ◽  
Ulrike Grittner ◽  
Nadine Külzow ◽  
Torsten Rackoll
Keyword(s):  
Pilot Study ◽  
Electric Fields ◽  
Standard Care ◽  
Small Sample Size ◽  
Small Sample ◽  
Related Factors ◽  
Attentional Deficits ◽  
Age Related ◽  
Current Densities ◽  
Improve Standard

Abstract Objective Neglect after stroke is a disabling disorder and its rehabilitation is a major challenge. Transcranial direct current stimulation (tDCS) seems to be a promising adjuvant technique to improve standard care neglect therapy. Since electric fields are influenced by age-related factors, higher current densities are probably needed for effective treatment in aged stroke patients. Validation of treatment efficacy requires sham-controlled experiments, but increased current densities might comprise blinding. Therefore, a pilot study was conducted to test sham adequacy when using current density of 0.8 A/m2. Whether especially neglect patients who mainly suffer from perceptual and attentional deficits are able to differentiate beyond chance active from sham tDCS was investigated in a randomized cross-over design (active/sham stimulation) in 12 early subacute patients with left-sided hemineglect. Stimulation (0.8 A/m2) was performed simultaneous to standard care neglect therapy. Results Odds ratio of correct guessing an atDCS condition compared to wrongly judge an atDCS condition as sham was 10.00 (95%CI 0.65–154.40, p = 0.099). However, given the small sample size and high OR, although likely somewhat overestimated, results require careful interpretation and blinding success in neglect studies with current densities of 0.8 A/m2 should be further confirmed.

Perceptions and Understanding of Diabetes Mellitus Technology in Adults with Type 1 or Type 2 DM: A Pilot Survey from Pakistan

2021 ◽  
pp. 193229682110111
Author(s):  
Sarah Nadeem ◽  
Uswah Siddiqi ◽  
Russell Seth Martins ◽  
Kaleemullah Badini
Keyword(s):  
Diabetes Mellitus ◽  
Pilot Study ◽  
Diabetes Care ◽  
Online Survey ◽  
Small Sample Size ◽  
Developed Countries ◽  
Small Sample ◽  
Cost Of Care ◽  
Cross Sectional ◽  
Specific Patient

Introduction: Diabetes mellitus technology (DMT) is increasingly used for routine management in developed countries, yet its uptake in developing countries is not as consistent. Multiple factors may influence this, including country specific patient perception regarding DMT. We conducted a pilot study in Pakistan to understand this important question which has not been studied yet. Methods: A cross-sectional pilot study was conducted in Pakistan. An anonymous survey exploring perceptions of diabetes technology was circulated on social media platforms, collecting responses over 2 weeks. Target population included adults (≥18 years) living in Pakistan, with DM1 or 2. Results: A total of 40 responses were received. The majority (36/40) reported using conventional glucometers. Nine used continuous glucose monitoring (CGM). Thirty-two of 40 patients believed DMT improved diabetes care, 22 felt it helped decreased risk of Diabetes-related complications. 15/40 stated that DMT results in increased cost of care. Sixteen reported their diabetes care teams had never discussed wearable DMT options whereas 11 disliked them because they did not want a device on their self. Conclusion: In our pilot study we have identified broad themes of opportunity and challenges to DMT use in Pakistan. Patients’ perceptions regarding DMT were generally positive but significant barriers to its acceptance included high cost, lack of discussion between doctor and patient about available technology and personal hesitation. Limitations of our study include sampling bias (online survey) and small sample size, but this data can help inform larger studies, to look at this important topic in greater detail.

Abstract 3725: Simvastatin but Not Pravastatin Affects Sleep: Findings from the UCSD Statin Study

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Beatrice A Golomb ◽  
Edwin K Kwon ◽  
Michael H Criqui ◽  
Joel E Dimsdale
Keyword(s):  
Sleep Quality ◽  
Rating Scale ◽  
Sleep Problems ◽  
Small Sample Size ◽  
Case Reports ◽  
Controlled Trial ◽  
Small Sample ◽  
T Test ◽  
Secondary Outcome ◽  
Regression Analyses

Background : Case reports have suggested possible effects of lipophilic statins on sleep in some subjects. Most randomized studies evaluating the effect of statins on sleep have had small sample size and short duration (≤ 6 weeks). Whether statins affect sleep on average, favorably or adversely, has been unclear. Goal : To assess the effects of lipophilic and hydrophilic statins on sleep. Subjects : 1016 adult men and women without diabetes or heart disease, with LDL-cholesterol 115–190mg/dL. Design : Randomized double blind placebo-controlled trial of simvastatin 20mg, pravastatin 40mg or placebo for 6 months. Sleep was a prespecified secondary outcome. It was assessed by both an adaptation of the Leeds sleep scale (a visual analog scale of sleep quality); and a rating scale of sleep problems. Both items were measured at baseline and on-treatment. Analysis : Baseline comparability of randomization groups including sleep measures was affirmed. T-test of mean on-treatment sleep scores across randomization groups was performed. This complemented regression analyses, adjusted for baseline values of the respective sleep assessment. Results : Groups were comparable at baseline on variables including both sleep measures. Simvastatin use was associated with significantly worse sleep quality, and significantly greater reported sleep problems than either pravastatin or placebo, by t-test and regression analyses. Pravastatin did not differ significantly from placebo on any sleep outcome. Conclusion : Findings were compatible with the hypothesis that statins may impair sleep in some subjects, and that this impairment may arise selectively with lipophilic statins. Table 1. Effects of Statins on Sleep: Regression Analysis

Serum Adsorption Study to Validate the Specificity of a Rapid Test to Detect Strongyloides stercoralis Infection

2021 ◽  
Author(s):  
Rahmah Noordin ◽  
Emelia Osman ◽  
Nor Suhada Anuar ◽  
Nor Mustaiqazah Juri ◽  
Anizah Rahumatullah ◽  
...  
Keyword(s):  
Small Sample Size ◽  
Rapid Test ◽  
High Specificity ◽  
Strongyloides Stercoralis ◽  
Cross Reactivity ◽  
Small Sample ◽  
Polystyrene Microspheres ◽  
Diagnostic Specificity ◽  
Serum Samples ◽  
Rapid Tests

A lateral flow rapid test for strongyloidiasis will greatly facilitate the control and elimination of the disease. Previously SsRapid™ prototype rapid test showed high diagnostic specificity to detect Strongyloides infection, determined using non-Strongyloides sera negative by IgG-ELISAs. Since high specificity is crucial before a test is used for public health control activities, further validation of its specificity is needed. Also, it needs to be ascertained whether non-Strongyloides sera positive by IgG-ELISAs and SsRapid are truly positive for Strongyloides or are cases of cross-reactivity. We performed 84 rapid tests (two types of dipsticks and cassettes) using 34 serum samples. They were divided into four groups based on Strongyloides infection and coinfection with other parasites and the availability of recombinant proteins and rapid tests for the latter. Sera was adsorbed using polystyrene microspheres beads separately coated with four recombinant parasite proteins. The small sample size is a limitation of this study; however, the overall results showed that the sera adsorption procedure was successful, and the SsRapid test is specific.

A Pilot Randomized Sham-Controlled Trial of MC5-A Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN)

2019 ◽  
Vol 35 (1) ◽  
pp. 53-58 ◽  
Author(s):  
Thomas J. Smith ◽  
A. Rab Razzak ◽  
Amanda L. Blackford ◽  
Jennifer Ensminger ◽  
Catherine Saiki ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Rating Scale ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Brief Pain Inventory ◽  
Small Sample ◽  
Sham Treatment ◽  
The Real ◽  
Average Pain ◽  
Scrambler Therapy

Background: Chemotherapy-induced peripheral neuropathy (CIPN) affects 30% to 40% of patients with cancer with long-lasting disability. Scrambler therapy (ST) appeared to benefit patients in uncontrolled trials, so we performed a randomized sham-controlled Phase II trial of ST. Methods: The primary end point was “average pain” after 28 days on the Numeric Rating Scale. Each received ten 30-minute sessions of ST on the dermatomes above the painful areas, or sham treatment on the back, typically at L3-5 where the nerve roots would enter the spinal cord. Outcomes included the Brief Pain Inventory (BPI)-CIPN and the EORTC CIPN-20 scale. Patients were evaluated before treatment (day 0), day 10, and days 28, 60, and 90. Results: Data regarding pain as a primary outcome were collected for 33 of the 35 patients. There were no significant differences between the sham and the “real” ST group at day 10, 28, 60, or 90, for average pain, the BPI, or EORTC CIPN-20. Individual responses were noted during the ST treatment on the real arm, but most dissipated by day 30. There was improvement in the sensory subscale of the CIPN-20 at 2 months in the “real” group ( P = .14). All “real” patients wanted to continue treatment if available. Discussion: We observed no difference between sham and real ST CIPN treatment. Potential reasons include at least the following: ST does not work; the sham treatment had some effect; small sample size with heterogeneous patients; misplaced electrodes on an area of nonpainful but damaged nerves; or a combination of these factors.

scholarly journals Osteopathic Manual Treatment vs Kaltenborn-Evjenth Orthopedic Manual Therapy for Chronic Low Back Pain: A Proposal for a Protocol for Randomized Trials

2020 ◽  
Vol 1 (8) ◽  
pp. 383-388
Author(s):  
Pawel Lizis ◽  
Wojciech Kobza ◽  
Grzegorz Manko ◽  
Jaroslaw Jaszczur-Nowicki ◽  
Joanna Bukowska ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Manual Therapy ◽  
Randomized Trials ◽  
Rating Scale ◽  
Small Sample Size ◽  
Randomized Study ◽  
Small Sample ◽  
Random Allocation ◽  
Low Back

Introduction: Numerous modalities of conservative therapeutic interventions are available to achieve the best health benefits in people with Low Back Pain (LBP), e.g., kinesiotherapy, physical therapy, behavior therapy. People with LBP continue to experience pain and disability despite receiving the best evidence based therapy. Osteopathic Manual Therapy (OMT) and Kaltenborn-Evjenth Ortopedic Manual Therapy (KEOMT) are the other options, although their effectiveness remains controversial. The aim of this study is a proposal for a protocol for randomized trials to compare the effectiveness of OMT vs. KEOMT on pain and disability in people suffering from LBP. Methods and analysis: It's a randomized study with two-arms parallel, designed with concealed allocation, the assessor's blinding with intention to-treat analysis. It will include 34 people a group with severe disability ranged from 41 to 60% in Oswestry Disability Index (ODI). There will be two groups: a treatment group (OMT) and a comparison group (KEOMT). All the patients in both groups will receive 2 treatments a week for 5 weeks. Each session in both groups will not exceed 30 minutes. During each session OMT and KEOMT techniques will be repeated 3 times. A baseline assessment will be performed pre and post intervention, two days later. The following parameters will be assessed during the evaluations: Numeric Pain Rating Scale – NPRS, ODI. Ethics and dissemination: The trial was approved by the Scientific Research Ethics Committee of University of Warmia and Mazury, Olsztyn, Poland. Registration approval number: 9/2018. Trial registration: The study protocol was prospectively registered in the Chinese Clinical Trial Registry on December 28, 2019 (registration ID: ChiCTR1900028580). Strengths and Limitations of this Study The participants' random allocation to the experimental and the control groups. The same experienced physiotherapist, blind to the outcome measures, provides the interventions. The same assistant, blind to the group allocation, administrates the outcomes. The same number of the interventions, the compared contact time with the physiotherapist providing the interventions. A short follow-up period and/or a rather small sample size.

Do you see what I see? A randomised pilot study to evaluate the effectiveness and efficiency of simulation-based training with videolaryngoscopy for neonatal intubation

2015 ◽  
Vol 1 (1) ◽  
pp. 12-18 ◽  
Author(s):  
Lindsay C Johnston ◽  
Ruijun Chen ◽  
Travis M Whitfill ◽  
Christie J Bruno ◽  
Orly L Levit ◽  
...  
Keyword(s):  
Pilot Study ◽  
Small Sample Size ◽  
Deliberate Practice ◽  
Neonatal Resuscitation ◽  
Technical Skills ◽  
Small Sample ◽  
Efficiency And Effectiveness ◽  
Global Skills ◽  
Visual Confirmation ◽  
Future Work

IntroductionDirect laryngoscopy (DL) and airway intubation are critical for neonatal resuscitation. A challenge in teaching DL is that the instructor cannot assess the learners’ airway view. Videolaryngoscopy (VL), which allows display of a patient's airway on a monitor, enables the instructor to view the airway during the procedure. This pilot study compared deliberate practice using either VL with instruction (I-VL) or traditional DL. We hypothesised that I-VL would improve the efficiency and effectiveness of neonatal intubation (NI) training.MethodsParticipants (students, paediatric interns and neonatal fellows) were randomised to I-VL or DL. Baseline technical skills were assessed using a skills checklist and global skills assessment. Following educational sessions, deliberate practice was performed on mannequins using the Storz C-MAC. With I-VL, the instructor could guide training using a real-time airway monitor view. With DL, feedback was based solely on technique or direct visual confirmation, but the instructor and learner views were not concurrent. During summative assessment, procedural skills checklists were used to evaluate intubation ability on a neonatal airway trainer. The duration of attempts was recorded, and recorded airway views were blindly reviewed for airway grade. ‘Effectiveness’ reflected achievement of the minimum passing score (MPS). ‘Efficiency’ was the duration of training for learners achieving the MPS.Results58 learners were randomised. Baseline demographics were similar. All participants had a significant improvement in knowledge, skills and comfort/confidence following training. There were no significant differences between randomised groups in efficiency or effectiveness, but trends towards improvement in each were noted. Fellows were more likely to achieve ‘competency’ postinstruction compared to non-fellows (p<0.001).ConclusionsThis educational intervention to teach NI increased the learner's knowledge, technical skills and confidence in procedural performance in both groups. I-VL did not improve training effectiveness. The small sample size and participant diversity may have limited findings, and future work is indicated.

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