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1.
J Med Internet Res ; 26: e40187, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38427424

RESUMO

BACKGROUND: Subthreshold depression (sD) is prevalent in older populations in long-term care (LTC) settings, but psychological therapy in LTC settings in China is not readily available. Thus, internet-based cognitive behavioral therapy (ICBT) may be suitable for this population, but research on the efficacy of ICBT for older adults with sD, especially those living in LTC settings, is limited. OBJECTIVE: This study aimed to evaluate the efficacy and acceptability of ICBT treatment for sD among LTC residents in China. We also examined whether ICBT is as effective as group-based cognitive behavioral therapy (CBT) for treating sD in this population. METHODS: We conducted a pragmatic randomized controlled trial, which included 18 LTC institutions. A total of 354 participants were randomized to ICBT, group-based CBT, or a waiting list and were followed up for 12 months. The primary outcome was self-reported depressive symptoms on the Center for Epidemiological Studies Depression Scale (CES-D). Secondary outcomes were the scores of the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder 7-Item (GAD-7), and Geriatric Depression Scale (GDS). A mixed-effects model was used to assess the efficacy of ICBT. RESULTS: The ICBT group showed a significant improvement in self-reported depressive symptoms, which was maintained at the 12-month follow-up (all P<.001). The ICBT group exhibited a significantly larger reduction in the scores of the CES-D (Cohen d=0.07, 95% CI 0.04-0.09; P=.01), PHQ-9 (d=0.30, 95% CI 0.28-0.33; P<.001), GDS (d=0.10, 95% CI 0.08-0.13; P<.001), and GAD-7 (d=0.19, 95% CI 0.17-0.22; P<.001) compared with a waiting list at postintervention. ICBT had significantly stronger effects than CBT on the PHQ-9 and GAD-7 at postintervention (d=0.15, 95% CI 0.13-0.17; P<.001 and d=0.21, 95% CI 0.19-0.23; P<.001, respectively), 6-month follow-up (d=0.18, 95% CI 0.16-0.21; P<.001 and d=0.18, 95% CI 0.15-0.21; P<.001, respectively), and 12-month follow-up (d=0.15, 95% CI 0.11-0.19; P<.001 and d=0.18, 95% CI 0.14-0.21; P<.001, respectively). CONCLUSIONS: ICBT is a relatively effective and acceptable intervention for reducing depressive symptoms among Chinese LTC residents with sD. These findings indicate the usefulness of ICBT application for sD in LTC settings. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000030697; https://www.chictr.org.cn/showproj.aspx?proj=50781.

2.
Diabetes Obes Metab ; 2024 Feb 29.
Artigo em Inglês | MEDLINE | ID: mdl-38425186

RESUMO

AIM: To investigate the efficacy and safety of pioglitazone compared to placebo when added to metformin plus dapagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, for patients with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: In a multicentre study, with a randomized, double-blind, placebo-controlled design, 249 Korean patients with T2DM suboptimally managed on metformin and dapagliflozin were assigned to receive either pioglitazone (15 mg daily) or placebo for 24 weeks, followed by a 24-week pioglitazone extension. Primary outcomes included changes in glycated haemoglobin (HbA1c), with secondary outcomes assessing insulin resistance, adiponectin levels, lipid profiles, liver enzymes, body weight and waist circumference. RESULTS: Pioglitazone administration resulted in a significant reduction in HbA1c levels (from 7.80% ± 0.72% to 7.27% ± 0.82%) compared with placebo (from 7.79% ± 0.76% to 7.69% ± 0.86%, corrected mean difference: -0.42% ± 0.08%; p < 0.01) at 24 weeks. Additional benefits from pioglitazone treatment included enhanced insulin sensitivity, increased adiponectin levels, raised high-density lipoprotein cholesterol levels and reduced liver enzyme levels, resulting in improvement in nonalcoholic fatty liver disease liver fat score. Despite no serious adverse events in either group, pioglitazone therapy was modestly but significantly associated with weight gain and increased waist circumference. CONCLUSIONS: Adjunctive pioglitazone treatment in T2DM inadequately controlled with metformin and dapagliflozin demonstrates considerable glycaemic improvement, metabolic benefits, and a low risk of hypoglycaemia. These advantages must be weighed against the potential for weight gain and increased waist circumference.

3.
JMIR Res Protoc ; 13: e53023, 2024 Feb 13.
Artigo em Inglês | MEDLINE | ID: mdl-38349737

RESUMO

BACKGROUND: Couples HIV testing and counseling (CHTC) is now a standard of care prevention strategy recommended by the Centers for Disease Control and Prevention for sexual minority men (SMM) in relationships. Despite standard recommendations that couples complete CHTC every 6-12 months, no study has empirically evaluated the effects associated with CHTC retesting. OBJECTIVE: This study aims to understand the benefits associated with continued dyadic engagement in the HIV prevention continuum through routine CHTC retesting, which is of particular importance for emerging-adult SMM in relationships who use drugs. METHODS: Eligible couples for this CHTC retesting trial must already be enrolled in the 4Us trial, where they completed a CHTC session after their baseline survey. The purpose of the original 4Us trial was to test the efficacy of 2 intervention components for CHTC: a communication skills training video and a substance use module. Couples were eligible for the original 4Us trial if they identified as cisgender male, were in a relationship for 3 months or longer, were aged 17 years or older, and communicated in English. At least 1 partner had to be aged 17-29 years, report HIV negative or unknown serostatus, report use of at least 1 drug (cannabis, cocaine or crack, crystal methamphetamine, ketamine, gamma-hydroxybuterate [GHB], psychedelics, ecstasy, prescription medication misuse, opiates, and nitrates) use, and engage in condomless anal sex (CAS) acts with a casual partner or have a main partner who is nonmonogamous or serodiscordant. Those who complete the 4Us 12-month follow-up and remain in a relationship with the partner they participated in 4Us with are offered the opportunity to participate in this CHTC retesting trial. Those consenting are randomized to either CHTC retesting or individual HIV testing. Follow-up assessments are conducted 3 and 6 months after randomization to evaluate the effects of repeat CHTC on 2 primary outcomes: (1) CAS with a casual partner in the absence of preexposure prophylaxis (PrEP), and (2) CAS with a serodiscordant main partner who is not virally suppressed or concurrent CAS between main and casual partners in the absence of PrEP. RESULTS: The CHTC retesting trial launched in January 2023, and enrollment is ongoing. As of February 2024, the study had enrolled 106 eligible participants (n=53 couples). CONCLUSIONS: Findings from this CHTC retesting study will contribute to knowledge about the benefits associated with regular (repeated) CHTC testing versus routine individual HIV testing for SMM in relationships. The results of this trial will inform CHTC retesting guidance. TRIAL REGISTRATION: ClinicalTrials.gov NCT05833074; htps://www.clinicaltrials.gov/study/NCT05833074. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53023.

4.
Front Pediatr ; 12: 1329648, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38361997

RESUMO

Introduction: The influence of social determinants of health (SDOH) on access to care and outcomes for critically ill children remains an understudied area with a paucity of high-quality data. Recent publications have highlighted the importance of incorporating SDOH considerations into research but the frequency with which this occurs in pediatric intensive care unit (PICU) research is unclear. Our objective was to determine the frequency and categories of SDOH variables reported and how these variables were defined in published PICU randomized controlled trials (RCTs). Methods: We searched Medline, Embase, Lilacs, and Central from inception to Dec 2022. Inclusion criteria were randomized controlled trials of any intervention on children or their families in a PICU. Data related to study demographics and nine WHO SDOH categories were extracted, and descriptive statistics and qualitative data generated. Results: 586 unique RCTs were included. Studies had a median sample size of 60 patients (IQR 40-106) with 73.0% of studies including ≤100 patients and 41.1% including ≤50 patients. A total of 181 (181/586, 30.9%) studies reported ≥1 SDOH variable of which 163 (163/586, 27.8%) reported them by randomization group. The most frequently reported categories were food insecurity (100/586, 17.1%) and social inclusion and non-discrimination (73/586, 12.5%). Twenty-five of 57 studies (43.9%) investigating feeding or nutrition and 11 of 82 (13.4%) assessing mechanical ventilation reported baseline nutritional assessments. Forty-one studies investigated interventions in children with asthma or bronchiolitis of which six reported on smoking in the home (6/41, 14.6%). Discussion: Reporting of relevant SDOH variables occurs infrequently in PICU RCTs. In addition, when available, categorizations and definitions of SDOH vary considerably between studies. Standardization of SDOH variable collection along with consistent minimal reporting requirements for PICU RCT publications is needed.

5.
Dement Neurocogn Disord ; 23(1): 30-43, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38362052

RESUMO

Background and Purpose: The SoUth Korea study to PrEvent cognitive impaiRment and protect BRAIN health through lifestyle intervention (SUPERBRAIN) proved the feasibility of multidomain intervention for elderly people. One-quarter of the Korean population over 65 years of age has mild cognitive impairment (MCI). Digital health interventions may be cost-effective and have fewer spatial constraints. We aim to examine the efficacy of a multidomain intervention through both face-to-face interactions and video communication platforms using a tablet personal computer (PC) application in MCI. Methods: Three hundred participants aged 60-85 years, with MCI and at least one modifiable dementia risk factor, will be recruited from 17 centers and randomly assigned in a 1:1 ratio to the multidomain intervention and the waiting-list control groups. Participants will receive the 24-week intervention through the tablet PC SUPERBRAIN application, which encompasses the following five elements: managing metabolic and vascular risk factors, cognitive training, physical exercise, nutritional guidance, and boosting motivation. Participants will attend the interventions at a facility every 1-2 weeks. They will also engage in one or two self-administered cognitive training sessions utilizing the tablet PC application at home each week. They will participate in twice or thrice weekly online exercise sessions at home via the ZOOM platform. The primary outcome will be the change in the total scale index score of the Repeatable Battery for the Assessment of Neuropsychological Status from baseline to study end. Conclusions: This study will inform the effectiveness of a comprehensive multidomain intervention utilizing digital technologies in MCI. Trial Registration: ClinicalTrials.gov Identifier: NCT05023057.

6.
Clin Nutr Res ; 13(1): 22-32, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38362131

RESUMO

Rheumatoid arthritis (RA) is a systemic inflammatory autoimmune disorder with widespread synovitis. Isoflavones, the main active component of soy, have been reported to have potent anti-inflammatory effects; the previous RA animal models showed the promising effect of soy supplementation. We aimed to evaluate the effect of soy bread on inflammatory markers and lipid profiles in RA patients. The present study was designed as a randomized controlled trial. RA patients were randomly allocated to obtain soy bread (n = 22) or placebo bread (n = 22) for 8 weeks. Fasting serum levels of lipid profile, total antioxidant capacity (TAC), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and DAS28 were checked. Findings showed that there were no significant differences between the two groups in physical activity and dietary intake at the beginning of the study and the end of the study. There were no significant differences between the two groups in measured lipid profile markers, including high-density lipoprotein, low-density lipoprotein, total cholesterol, triglyceride, and very low-density lipoprotein, at the end of the trial. In addition, TAC and CRP also were not significant at the end of the trial between the 2 groups (0.66 and 0.12, respectively). However, the serum levels of TNF-α reduced significantly in the soy bread group at the end of the intervention (p < 0.000) and compared with the control group (p < 0.019). Soy bread consumption only decreased circulating TNF-α serum concentration. Other outcome measures were not changed following supplementation. Future long-term, well-designed studies are needed to confirm these findings. Trial Registration: Iranian Registry of Clinical Trials Identifier: IRCT20181021041396N1.

7.
Clin Nutr Res ; 13(1): 74-87, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-38362130

RESUMO

Since the effects of cinnamon supplementation on lipid profiles are still controversial, this study conducted a meta-analysis of randomized controlled trials to assess the effect of cinnamon supplementation on lipid profiles. The study was designed and conducted according to the guidelines of the 2020 preferred reporting items for systematic reviews and meta-analysis (PRISMA) statements. A systematic and comprehensive search was performed in several databases from inception up to 11 November 2023. The meta-analysis on the impact of Cinnamon on lipid profiles indicates a non-significant overall effect on low-density lipoprotein (weighted mean differences [WMD], -2.48; 95% confidence interval [CI], -9.70, 4.72). However, significant reductions are seen with doses < 500 mg/day (-10.26), and non-significant increases with doses ≥ 500 mg/day (1.18). The overall effect on high-density lipoprotein is non-significant (WMD, 3.97; 95% CI, -7.877, 15.831), showing varying responses at different doses. Triglycerides exhibit a significant overall reduction (WMD, -6.88; 95% CI, -12.62, -1.15), particularly in the < 500 mg/day group. The overall effect on cholesterol is non-significant (WMD, -4.314; 95% CI, -15.011, 6.384), with diverse responses at different doses. High heterogeneity underlines the importance of standardized study designs and further exploration of dosage-specific effects. Findings from this study suggest that cinnamon supplements might be beneficial to modulate the blood lipid profile.

8.
Int J Behav Med ; 2024 Feb 20.
Artigo em Inglês | MEDLINE | ID: mdl-38378973

RESUMO

BACKGROUND: The global COVID-19 pandemic has impaired the health and living conditions of millions of people. For governments to formulate policies promoting vaccination behavior, it is important to understand individuals' intentions to vaccinate. This study explores the effectiveness of a brief online intervention based on the Health Action Process Approach (HAPA) in improving individuals' COVID-19 vaccination intention, as well as considering the reasons for their unwillingness to get vaccinated. METHOD: A total of 1,258 participants were assessed using a questionnaire to determine their phase of vaccination intention (pre-intention, intention, and action). Subsequently, focused on the underlying factors in the pre-intention phase (i.e., task self-efficacy, outcome expectation, and risk perception), a 7-day randomized controlled HAPA intervention (n intervention = 57, n control = 49) was conducted online for individuals who were not willing to get vaccinated. The measurement points included pre- (T1), post- (T2), and 30-day follow-up (T3). RESULTS: The intervention may effectively improve participants' COVID-19 vaccination intentions; however, it had no impact on their planning and actions involved in taking the vaccine. CONCLUSIONS: This study provides relevant reference data for government stakeholders to use in developing public awareness campaigns and policies to encourage COVID-19 vaccination.

10.
Alzheimers Dement ; 2024 Feb 21.
Artigo em Inglês | MEDLINE | ID: mdl-38380503

RESUMO

INTRODUCTION: Adverse effects of monoclonal antibodies against amyloid beta are common, and may affect validity of randomized controlled trials (RCTs) through unblinding of participants. METHODS: We used observations from published phase 3 RCTs in Alzheimer's disease to calculate the magnitude of unblinding effects on cognition that would be required to explain observed cognitive benefits in RCTs. RESULTS: In trials of lecanemab, aducanumab, and donanemab, incidence of amyloid-related imaging abnormalities with active treatment ranged from 22% to 44%, the vast majority of which presumably led to unblinding. Effects of unblinding on the Clinical Dementia Rating Sum of Boxes required to fully explain observed drug effects ranged from 1.1 point (95% confidence interval: 0.2-2.0) with aducanumab, to 3.3 points (2.1-4.4) with donanemab and 3.7 points (2.0-5.6) with lecanemab. Infusion-related reactions were common, with potential unblinding effects particularly for lecanemab. Similar patterns were observed for the Alzheimer's Disease Assessment Scale Cognitive subscale. DISCUSSION: Psychological treatment effects due to unblinding may explain a substantial share of observed treatment effects in RCTs.

11.
Internet Interv ; 35: 100721, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38370287

RESUMO

Background: Following discharge, it is crucial for patients to transfer intentions and action plans from inpatient rehabilitation into everyday life. This ensures their reintegration into social and working life and prevents economic costs due to sick leave or reduced earning capacity pension. However, most established aftercare programs do not specifically address occupational problems or challenges during occupational measures such as graded return to work. The aim of this study is to evaluate the efficacy of the low-threshold online self-help intervention marena (Meine Arbeitsbezogene Reha-Nachsorge - My Work-related Rehabilitation Aftercare) to support return to work. Methods: A two-arm randomized-controlled-trial (RCT) will be conducted. A total of N = 400 rehabilitation inpatients across different indication areas (psychosomatic, orthopedic, or cardiologic) aged 18 to 65 years with a planned return to work after medical rehabilitation, have a heightened social-medical risk and private internet access and are insured with the German Pension insurance or statutory health insurance, will be recruited in four medical and psychosomatic clinics in Germany. Participants will be allocated to either the intervention (IG) or the control group (CG). In a stepped-care model, participants of the IG will receive access to the non-guided internet- and mobile-based intervention marena (IG subgroup 1) or marena in combination with GSA-Online plus (IG subgroup 2), a guided psychodynamic internet-based intervention that has proven effective in two trials regarding occupational and health objectives. Based on a priori defined indication criteria, clinic staff will recommend either IG subgroup 1 or IG subgroup 2. The CG will receive optimized treatment as usual with access to a survey feature within marena. The primary outcome will be work status after 6 months (T2) and 12 months (T4). The endpoint at 12 months (T4) after discharge from inpatient rehabilitation will be considered as secondary endpoint. Work status is defined as positive if the participant is working and has ≤ 6 weeks of sick leave at T2 and ≤ 12 weeks of sick leave at T4. Secondary outcomes include successful completion of graded return to work, successful application for benefits for participation in working life, current work ability, social-medical risk, subjective prognosis of future employment, quality of life, somatic symptoms, coping, social support, depression, anxiety, and psychosocial stress. Discussion: This study will contribute to the evidence concerning efficacy of online aftercare interventions. If proven efficacious, marena could provide an individualized and adaptable self-help approach to promote return to work following inpatient rehabilitation.

12.
BMC Cardiovasc Disord ; 24(1): 90, 2024 Feb 06.
Artigo em Inglês | MEDLINE | ID: mdl-38321368

RESUMO

INTRODUCTION: Aspirin is widely used for secondary prevention in patients with hypertension. However, previous studies mainly focused on the preventive effects of aspirin, and there has been a lack of reliable evidence on whether taking aspirin affects blood pressure This study aimed to investigate whether aspirin would affect the blood pressure in patients with hypertension. METHODS: PubMed, Cochrane database, Embase, Scopus and Medline databases were searched until September 2023. For continuous variables (e.g., blood pressure reduction), the mean difference (MD) was selected as the effect magnitude indices. We used the Cochrane Collaboration's Risk of Bias tool to assess the risk of bias. RESULT: A total of five studies were included, comprising 20,312 patients. We found that aspirin did not affect SBP (MD = -0.78, 95% CI: - 2.41, 0.84). A similar result was found for DBP (MD = -0.86, 95% CI: - 2.14, 0.42). CONCLUSION: This study showed no significant difference in blood pressure between the aspirin and control groups, suggesting that aspirin does not affect blood pressure.


Assuntos
Hipertensão , Hipotensão , Humanos , Pressão Sanguínea
13.
Artigo em Inglês | MEDLINE | ID: mdl-38307162

RESUMO

PURPOSE: Evidence on non-pharmacological interventions for adolescents with type 1 diabetes is unclear. This review aimed to evaluate the effectiveness of non-pharmacological intervention in adolescents with type 1 diabetes. METHODS: We conducted a search on databases from November 11 to 19, 2022, for randomized controlled trials for the effects of non-pharmacological intervention in adolescents with type 1 diabetes. To identify recent research trends, we included studies published from 2017 to November 2022. The risk of bias was assessed using the Cochrane Risk of Bias Tool 2.0. To estimate the effect size, a meta-analysis was performed using RevMan 5.4 program and R Studio. RESULTS: A total of 45 studies were included in the systematic review. Among those, 30 studies were included in the meta-analysis. Non-pharmacological interventions were significantly effective in improving HbA1c (SMD=-0.26, 95% CI: -0.42, -0.09), quality of life (SMD=0.44, 95% CI: 0.13 to 0.76), anxiety (SMD=-0.91, 95% CI: -1.26, -0.56), and blood glucose (SMD=-1.62, 95% CI: -2.22, -1.01). Subgroup analysis showed that duration of intervention was not a covariate related to HbA1c levels. CONCLUSIONS: Non-pharmacological interventions have shown effectiveness in improving the HbA1c, quality of life, anxiety, and blood glucose in adolescents with type 1 diabetes. Future studies with more rigorous methodology are needed to confirm and strengthen the validity of these findings. Additionally, attention to changes in the lipid profile and self-care motivation among adolescents with type 1 diabetes is warranted. TRIAL REGISTRATION NUMBER: PROSPERO (CRD42022382190).

14.
J Hepatol ; 2024 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-38307346

RESUMO

Randomized controlled trials (RCTs) represent the gold standard for evidence generation across all areas of medicine and especially in the oncology field, as they allow unbiased estimates of treatment effect without confounders. Observational studies have many problems that could reduce their internal and external validity. However, large prospective (well-conducted) observational real-world studies (RWS) can detect the occurrence of rare adverse events or monitoring for long-term adverse events. Impact of Real Word Data (RWD), which refers to data generated from routine, standard care of patients, and real-world 'evidence' (RWE), which is the evidence generated from RWD represent an open challenge. Hepatocellular carcinoma (HCC) is the fourth leading cause of cancer death worldwide and its prognosis is highly heterogeneous, being related not only to tumor burden but also to the severity of underlying chronic liver disease. Moreover, advances in systemic therapies for HCC have increased the complexity of HCC patient management. Aim of this review article is to provide an overview of the benefits and limitations of different study designs, particularly focusing on RCTs and observational studies, to address important and not fully resolved questions in HCC research.

15.
Pak J Med Sci ; 40(3Part-II): 487-491, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38356837

RESUMO

Objectives: Non-adherence to tuberculosis (TB) treatment is the leading cause of the increase in drug resistance cases. This study will determine the effectiveness of pharmaceutical-care-based interventions coupled with short messages delivered by a pharmacist on treatment outcomes and adherence among TB patients. Methods: The study will be conducted in TB Control Center of Pakistan Institute of Medical Sciences Hospital, Islamabad and District Bannu TB Control Center time period will be from August 2019 to September 2021. The patients will be included into the control group (usual care) or the intervention group pharmaceutical care and SMS reminder. The primary outcome includes a change in mean score from baseline in treatment outcomes and adherence, measured by Morisky Medication Adherence Scale, and clinic appointment attendance registration. Secondary outcomes include health-related quality of life of patients, disease knowledge, and patient satisfaction with the intervention. Result: The major issues in patients with TB are cure rate and medication adherence. The method anticipated in this manuscript could set the foundation of pharmaceutical care and mobile SMS for the future provision of care to improve TB treatment outcomes. Conclusion: The study will make available fundamental information about the influence of the patient centered program on the adherence and clinical outcomes of patients with TB.Trial status and registration: Clinical Trials.gov assigned Identifier NCT04645836.

17.
J Cosmet Dermatol ; 2024 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-38299457

RESUMO

INTRODUCTION: Topical therapy is the mainstay treatment of acne, and topical retinoids such as tretinoin, tazarotene, and adapalene are recommended as the first-line therapy for mild to moderate acne. However, the cutaneous irritations may occur, and the dermocosmetics are recommended to prevent side effects of anti-acne drugs and adhere to treatment. Thus, this study aims to compare the efficacy and tolerability of ceramides and niacinamide-containing moisturizer (CCM) versus hydrophilic cream in combination with topical anti-acne treatment in mild to moderate acne vulgaris. METHODS: This was an 8-week, randomized, double-blinded, split face study in 40 patients assigned for topical anti-acne medications (5% benzoyl peroxide and 0.1% adapalene gel), then randomly applied CCM or hydrophilic cream. All patients were followed at week 0, 2, 4, and 8 for acne improvement, adverse reactions, biometric, and biophysical evaluation. RESULTS: CCM could significantly improve the non-inflammatory, inflammatory, and total acne lesions compared with hydrophilic cream after week 8 of treatment. Interestingly, there was an improvement of global worst score, hemoglobin index, melanin index, TEWL, skin hydration, sebum production, and skin surface pH, with no statistically significant differences between the two treatments. No serious side effects from clinical application of CCM and hydrophilic cream in mild to moderate acne vulgaris patients. CONCLUSION: Ceramide and niacinamide-containing moisturizer in combination with anti-acne medication can significantly improve acne lesions and decrease cutaneous irritations toward a satisfactory treatment outcome of mild to moderate acne vulgaris.

18.
Pilot Feasibility Stud ; 10(1): 24, 2024 Feb 05.
Artigo em Inglês | MEDLINE | ID: mdl-38317264

RESUMO

BACKGROUND: Many patients with posttraumatic stress disorder (PTSD) suffer from sleep problems. Robot-based interventions might be an innovative approach to reduce sleep problems and hyperarousal in PTSD. However, the feasibility and effectiveness of a breath robot in patients with PTSD have never been empirically tested. The aim of this study is to investigate the feasibility of a breath robot to reduce sleep problems and hyperarousal in patients with PTSD. METHODS: This randomized controlled feasibility study will include N = 30 adult patients with at least subsyndromal PTSD (PTSD Symptom Scale - Interview-5 (PSSI-5)) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) and impaired sleep quality (Pittsburgh Sleep Quality Index (PSQI) > 5). Patients with organic sleep disorders or currently in psychotherapeutic treatment are excluded. Study participants are randomized to receive either a 4-week Somnox 2 robot intervention including simulation of human breath or a 4-week Somnox 2 robot intervention without human breath simulation. The primary outcome will be the proportion of randomized participants providing outcome data at post-treatment. We consider a proportion of > 50% to indicate feasibility. Additional feasibility outcomes include eligibility rate, recruitment speed, uptake, retention, treatment adherence, and dropout. Potential outcomes of effectiveness (sleep quality, PSQI; severity of PTSD symptoms, PSSI-5) will be assessed at two time points, before (T0) and after (T1) the intervention. Sleep characteristics (Consensus Sleep Diary (CSD)) are measured daily. DISCUSSION: This study is the first to investigate the feasibility of a novel breath robot intervention for reducing sleep problems and hyperarousal in PTSD patients, with effectiveness considered as a secondary outcome. If feasible and effective, the use of a breath robot could be a nonintrusive and flexible intervention to supplement psychotherapy or to bridge treatment gaps. TRIAL REGISTRATION: DRKS, DRKS00031063. Registered on 10/012023.

19.
Front Psychol ; 15: 1291198, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38384348

RESUMO

Introduction: Attention Deficit Hyperactivity Disorder (ADHD) has a global mean prevalence of 5%. Cognitive Training (CT) and Mindfulness-Based Interventions (MBIs) have shown promising results in managing ADHD symptoms, but they are not its Treatment-As-Usual (TAU). The NeuroMind Study aims to evaluate the preliminary effectiveness and feasibility of three interventions: Mindfulness for Health (M4H), CT using the NeuronUP® platform (CT), and a combination of both, Mindfulness Cognitive Training (MCT). There is empirical evidence supporting the effectiveness of the M4H and NeuronUP® platform; however, this study explores for the first time the effectiveness of MCT and CT, as well as the integration of M4H into TAU. The objectives of this 5-month Randomized Controlled Trial (RCT) are: (1) To analyze the preliminary effectiveness and feasibility of M4H, CT or a combination of both (MCT) added to TAU for children with ADHD; (2) To evaluate the role of psychological process variables (mindfulness and emotional regulation) as mediators of 5-month follow-up clinical outcomes; (3) To preliminarily explore whether specific sociodemographic and clinical characteristics can predict the short-and medium-term clinical response to the specific treatments. Methods and analysis: Participants will be 120 children (7 to 12 years) with ADHD recruited at Child and Adolescent Mental Health Service (CAMHS) Sant Joan de Déu Terres de Lleida (Spain) randomly allocated to one of the four study arms: TAU vs. TAU + CT vs. TAU + M4H vs. TAU + MCT. An assessment to collect ADHD symptoms, Executive Functions (EF), comorbid symptoms and global functioning will be conducted pre-intervention, post-intervention (2 months after baseline) and at the 5-month follow-up. Linear mixed models and mediational models will be computed. Discussion: If the preliminary effectiveness and feasibility of the MCT are demonstrated, this study could be a preliminary basis to do a full RCT with a larger sample to definitively validate the intervention. The MCT could be applied in clinical practice if it is definitively validated.Clinical trial registration:ClinicalTrials.gov, identifier, NCT05937347. https://clinicaltrials.gov/study/NCT05937347?locStr=Spain&country=Spain&cond=ADHD&intr=Mindfulness&rank=1.

20.
Helicobacter ; 29(1): e13061, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38411303

RESUMO

BACKGROUND: Helicobacter pylori (H. pylori) is strongly associated with peptic ulcer disease and gastric cancer. We evaluated two triple therapy regimens comprising esomeprazole, high dose bismuth, and different doses of amoxicillin for first-line H. pylori eradication. MATERIALS AND METHODS: Two hundred patients with dyspepsia and naive H. pylori infection were randomly assigned into two groups (n = 100). Both groups were treated for 14 days similarly with esomeprazole (40 mg, twice daily) and bismuth subcitrate (240 mg, three times daily), but the dose of amoxicillin was varied between Groups A (750 mg) and B (1000 mg) three times daily. Treatment compliance and side effect were evaluated following the therapies and after 8 weeks, a negative test of stool H. pylori antigen confirmed eradication. RESULTS: The two groups were comparable with respect to sex and age. According to intention to treat analysis, eradication rates were 80% (95% CI: 77.2%-82.8%) and 90% (95% CI: 84.1%-95.9%) in A and B groups, respectively (p = 0.22). Per-protocol eradication rates were 87% (95% CI: 80.4%-93.6%) and 92.8% (95% CI: 87.7%-97.9%), respectively (p = 0.23). Severe adverse effects were 3% and 2%, respectively (p = 0.34). CONCLUSION: High dose esomeprazole, amoxicillin and bismuth achieved 92.8% cure rates per protocol in a country with a high background rate of resistance. Additional studies are needed to ascertain whether this therapy can be further improved. Until then, it can be recommended as a first-line H. pylori eradication in north of Iran.


Assuntos
Infecções por Helicobacter , Helicobacter pylori , Compostos Organometálicos , Humanos , Infecções por Helicobacter/tratamento farmacológico , Amoxicilina/efeitos adversos , Esomeprazol/efeitos adversos , Projetos Piloto , Antibacterianos/efeitos adversos , Bismuto/efeitos adversos , Irã (Geográfico) , Inibidores da Bomba de Prótons/efeitos adversos , Quimioterapia Combinada
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