UNASSIGNED: In West Africa, healers greatly outnumber trained mental health professionals. People with serious mental illness (SMI) are often seen by healers in \"prayer camps\" where they may also experience human rights abuses. We developed \"M&M,\" an 8-week-long dual-pronged intervention involving (1) a smartphone-delivered toolkit designed to expose healers to brief psychosocial interventions and encourage them to preserve human rights (M-Healer app), and (2) a visiting nurse who provides medications to their patients (Mobile Nurse).
UNASSIGNED: We examined the feasibility, acceptability, safety, and preliminary effectiveness of the M&M intervention in real-world prayer camp settings.
UNASSIGNED: We conducted a single-arm field trial of M&M with people with SMI and healers at a prayer camp in Ghana. Healers were provided smartphones with M-Healer installed and were trained by practice facilitators to use the digital toolkit. In parallel, a study nurse visited their prayer camp to administer medications to their patients. Clinical assessors administered study measures to participants with SMI at pretreatment (baseline), midtreatment (4 weeks) and post treatment (8 weeks).
UNASSIGNED: Seventeen participants were enrolled and most (n=15, 88.3%) were retained. Participants had an average age of 44.3 (SD 13.9) years and 59% (n=10) of them were male. Fourteen (82%) participants had a diagnosis of schizophrenia and 2 (18%) were diagnosed with bipolar disorder. Four healers were trained to use M-Healer. On average, they self-initiated app use 31.9 (SD 28.9) times per week. Healers watched an average of 19.1 (SD 21.2) videos, responded to 1.5 (SD 2.4) prompts, and used the app for 5.3 (SD 2.7) days weekly. Pre-post analyses revealed a significant and clinically meaningful reduction in psychiatric symptom severity (Brief Psychiatric Rating Scale score range 52.3 to 30.9; Brief Symptom Inventory score range 76.4 to 27.9), psychological distress (Talbieh Brief Distress Inventory score range 37.7 to 16.9), shame (Other as Shamer Scale score range 41.9 to 28.5), and stigma (Brief Internalized Stigma of Mental Illness Scale score range 11.8 to 10.3). We recorded a significant reduction in days chained (1.6 to 0.5) and a promising trend for reduction in the days of forced fasting (2.6 to 0.0, P=.06). We did not identify significant pre-post changes in patient-reported working alliance with healers (Working Alliance Inventory), depressive symptom severity (Patient Health Questionnaire-9), quality of life (Lehman Quality of Life Interview for the Mentally Ill), beliefs about medication (Beliefs about Medications Questionnaire-General Harm subscale), or other human rights abuses. No major side effects, health and safety violations, or serious adverse events occurred over the course of the trial.
UNASSIGNED: The M&M intervention proved to be feasible, acceptable, safe, and clinically promising. Preliminary findings suggest that the M-Healer toolkit may have shifted healers\' behaviors at the prayer camp so that they commit fewer human rights abuses.

BACKGROUND: Chronic pain is a distressing condition that should be treated in specialized pain clinics. Pain clinics offer a holistic, evidence-based approach, including pharmacological, complementary, and invasive treatments. This study aimed to provide preliminary information regarding chronic pain treatments and identify reasons for accessing an important hub-spoke pain clinic network.
METHODS: A retrospective multicenter cross-sectional study was carried out. A total of 1606 patients\' records were included. Patients were selected from the 26 pain clinics of a single region in Italy. Univariate and multivariate logistic regression models were used.
RESULTS: Multivariate models showed that the use of opioids were considered effective for severe or moderate pain [odds ratio (OR) 0.41; 95% 0.33-0.51], while the use of invasive treatments (OR 2.45; 95% 1.95-3.06) and the use of complementary therapy (OR 1.87; 95% 1.38-2.51) were associated with severe or moderate pain. Overall, age, sex, nonsteroidal anti-inflammatory drugs (NSAID) use, a combination of NSAIDs, complementary therapies, and a combination of opioids and invasive treatments did not seem to be significantly associated with the nature of pain. Multivariate models confirmed that clinical parameters such as the nature of pain, multi-diagnosis, more than one site of pain, treatments, and general practitioner, but not the severity of pain and use of invasive treatments, had an impact on the choice of a pain clinic.
CONCLUSIONS: Opioids are useful in managing moderate or severe chronic pain. Multimodal approaches are used for the management of chronic pain. Moreover, it is not clear how patients are addressed to access different pain clinics (spoke versus hub) networks. More widespread adoption is needed for an interdisciplinary approach to managing chronic pain and adopting guideline recommendations, and rigorous research is required to provide more substantial evidence and support clinical practice.

BACKGROUND: Intravenous (IV) ketamine and intranasal (IN) esketamine have been studied as novel alternatives to manage treatment-resistant depression (TRD). The objective of this observational pilot study is to compare the real-world effectiveness and tolerability of IV ketamine and IN esketamine in the management of unipolar TRD.
OBJECTIVE: To compare the effectiveness (primary outcome measure) and tolerability (secondary outcome measure) of racemic ketamine and esketamine in the management of TRD in adults and provide an expert qualitative commentary on the application of IV ketamine and IN esketamine in clinical practice (exploratory objective), focusing on the recruitment process, patient retention, effectiveness, and tolerability of the treatments.
METHODS: This is a multicenter prospective observational study of naturalistic clinical practice. We expect to recruit 10 patients per treatment arm-IV ketamine or IN esketamine per center (2 centers, total 40 subjects). Patients experiencing moderate to severe TRD and who are candidates for receiving low-dose IV ketamine treatments or IN esketamine as part of their standard-of-care treatments will be recruited. We will measure the effectiveness of each treatment arm by measuring the severity of depression symptoms using the Montgomery and Åsberg Depression Rating Scale; tolerability, side effects, and the appearance of dissociation symptoms using the simplified 6-item version of the Clinician Administered Dissociative Symptom Scale (CADSS-6); and potential for abuse using a Likeability and Craving Questionnaire. Logistic regression will examine odds ratios, number needed to treat for response and remission, number needed to harm, and likelihood to be helped or harmed of each treatment. Covariate analysis will assess the impact of site and demographic variables on treatment efficacy.
RESULTS: This observational trial was approved by the Queen\'s University Health Science and Affiliated Teaching Hospital\'s Research Ethics Board in February 2021. The two research centers involved have started patient recruitment. Our research center (Providence Care Hospital, Kingston, Ontario) has recruited 9 patients so far. We expect to finalize data gathering by August 2022. The manuscript is expected to be published by December 2022.
CONCLUSIONS: We hypothesize that both treatments will have comparable rapid and robust antidepressant effects and similar tolerability profiles in a real-world setting for the management of TRD.
UNASSIGNED: DERR1-10.2196/34711.

Chronic obstructive pulmonary disease (COPD) patients constitute a heterogeneous population in terms of treatment response. Our objective was to identify possible predictive factors of response to treatment with single bronchodilation monotherapy in patients diagnosed with COPD. The Time-based Register and Analysis of COPD Endpoints (TRACE; clinicaltrials.gov NCT03485690) is a prospective cohort of COPD patients who have been attending annual visits since 2012. Patients who were kept on a single bronchodilator during the first year of follow-up were selected. The responders were defined according to all of the following variables: any improvement in morning post-dose forced expiratory volume in 1 s or deterioration <100 mL, no change or improvement in dyspnea score, and no occurrence of exacerbations. Significant and plausible variables were analyzed using a proportional hazard Cox regression for single bronchodilator responders. We analyzed 764 cases, of whom 128 (16.8%) were receiving monotherapy with one bronchodilator. Of these, 85 patients (66.4%) were responders. Factors affecting responder status were: female gender (hazard ratio (HR) 0.276; 95% confidence interval (CI) 0.089-0.858), dyslipidemia (HR 0.436; 95%CI 0.202-0.939), not performing regular exercise (HR 0.523; 95%CI 0.254-1.076), active smoking (HR 0.413; 95%CI 0.186-0.920), and treatment adherence (HR 2.527; 95%CI 1.271-5.027). The factors associated with a single bronchodilation response are mainly non-pharmacological interventions and comorbidities.

Behaviour management strategies involving pharmacological or non-pharmacological interventions during dental procedures should be considered to attain safe and successful treatment outcomes. This study compared the frequencies of use and the completeness of treatment with these interventions.
A total of 1725 dental records of patients up to 18 years old, who were treated in the King Abdulaziz Medical City in Jeddah City from October 2018 to June 2019, were used in this retrospective, cross-sectional study. Inferential analysis, Chi-square test, Kruskal-Wallis test, and regression model were used in the data analysis.
About two-thirds of the patients were treated with attendant non-pharmacological interventions, while one-third, with pharmacological interventions. The application of General Anesthesia (GA) was the most frequently used intervention. Restorative procedures and extractions were done in higher frequencies with pharmacological interventions. Treatments with space maintainers and orthodontic appliances were carried out in higher frequencies with non-pharmacological strategies. The choice of intervention was significantly influenced by the systemic conditions of the patients. Patients treated with non-pharmacological intervention comprised the dominant type of patients, because they required treatments with less pain. Those treated with GA needed restorative treatments and extractions, or treatments that involve pain, but these treatments had higher frequencies of being completed.
The treatments with pharmacological intervention through GA have higher frequencies of being completed, compared to those with non-pharmacological interventions. Factors, such as age, potential to complete the treatment, and the type of dental treatment applied, influence the choice of treatment intervention.

BACKGROUND: COVID-19, caused by the virus SARS-CoV-2, has brought extensive challenges to the scientific community in recent months. Several studies have been undertaken in an attempt to minimize the impact of the disease worldwide. Although new knowledge has been quickly disseminated, including viral mechanisms, pathophysiology, and clinical findings, there is a lack of information on the effective pharmacological management of this disease. In vitro studies have shown some benefits related to the use of antimalarials (chloroquine and hydroxychloroquine) for inhibiting SARS-CoV-2. However, the data from open clinical trials on COVID-19 patients are controversial.
OBJECTIVE: We present the protocol for a research project that compares the potential protective effect of antimalarials in preventing moderate-to-severe forms of COVID-19 in two groups: (1) patients treated chronically with antimalarials for rheumatic diseases and (2) other members of the patients\' household who have not been diagnosed with rheumatic diseases and are not taking antimalarials.
METHODS: This is a 24-week, prospective, observational cohort study comprising patients from public and private health services across Brazil, who chronically use antimalarials for the treatment of immune-mediated rheumatic diseases, osteoarthritis, or chikungunya-related arthropathy. A total of six sequential phone interviews were scheduled during the COVID-19 outbreak in five different regions of Brazil. Information regarding social, epidemiological, and demographic data, as well as details about rheumatic diseases, antimalarials, comorbidities, and concomitant medication, is being recorded using a specific online form in the REDCap database. Symptoms suggestive of COVID-19, including fever, cough, dyspnea, anosmia, and dysgeusia, are being self-reported and collected via phone interviews. Our main outcomes are hospitalization, need of intensive care unit, and death.
RESULTS: Recruitment began at the end of March 2020, and the inclusion was done during an 8-week period (from March 29 to May 17) with a total of 10,443 individuals enrolled at baseline, 5166 of whom have rheumatic diseases, from 23 tertiary rheumatology centers across 97 Brazilian cities. Data analysis is scheduled to begin after all inclusion data have been collected.
CONCLUSIONS: This study, which includes a large sample of chronic antimalarial users, will allow us to explore whether SARS-CoV-2 infection may be associated with immune-mediated rheumatic diseases and long-term antimalarial usage.
BACKGROUND: Brazilian Registry of Clinical Trials RBR-9KTWX6; http://www.ensaiosclinicos.gov.br/rg/RBR-9ktwx6/.
UNASSIGNED: DERR1-10.2196/23532.

The participation of natural products in health care has been remarkable, and today they continue to play a key role in the discovery and development of new treatments. Phytochemical studies together with pharmacological tests have managed to integrate bioactive agents as an alternative solution to reduce or regulate the problems caused by diseases. The Eysenhardtia genus is a family of plants that are rich in secondary metabolites, which have shown potential activity in the control and mitigation of urinary disorders, diabetes, oxidative stress, protein glycosylation, microbial infections, inflammation, pain or discomfort, muscle contractions, cytotoxicity, or as a cellular or neuronal signaling modulator. These conditions generally appear in comorbid diseases, which motivated the bibliographic review associated with the plant. This document presents the beneficial actions produced by Eysenhardtia extracts and/or bioactives to inhibit, control, or reduce the complications or discomfort of degenerative diseases and thus generate new therapeutic alternatives.

Geriatric depression is difficult to treat and frequently accompanied by cognitive complaints that increase risk for dementia. New treatment strategies targeting both depression and cognition are urgently needed.
We conducted a 6-month double-blind placebo-controlled trial to assess the efficacy and tolerability of escitalopram + memantine (ESC/MEM) compared to escitalopram + placebo (ESC/PBO) for improving mood and cognitive functioning in depressed older adults with subjective memory complaints (NCT01902004). Primary outcome was change in depression as assessed by the HAM-D post-treatment (at 6 months). Remission was defined as HAM-D ≤6; naturalistic follow-up continued until 12 months.
Of the 95 randomized participants, 62 completed the 6-month assessment. Dropout and tolerability did not differ between groups. Mean daily escitalopram dose was 11.1 mg (SD = 3.7; range: 5-20 mg). Mean daily memantine dose was 19.3 mg (SD = 2.6; range 10-20 mg). Remission rate within ESC/MEM was 45.8% and 47.9%, compared to 38.3% and 31.9% in ESC/PBO, at 3 and 6 months, respectively (χ2(1) = 2.0, p = 0.15). Both groups improved significantly on the HAM-D at 3, 6, and 12 months, with no observed between-group differences. ESC/MEM demonstrated greater improvement in delayed recall (F(2,82) = 4.3, p = 0.02) and executive functioning (F(2,82) = 5.1, p = 0.01) at 12 months compared to ESC/PBO.
The combination of memantine with escitalopram was well tolerated and as effective as escitalopram and placebo in improving depression using HAM-D. Combination memantine and escitalopram was significantly more effective than escitalopram and placebo in improving cognitive outcomes at 12 months. Future reports will address the role of biomarkers of aging in treatment response.

Recombinant secreted frizzled-related protein 5 (sFRP5) improved periodontal status in mice. Thus, this study aimed to investigate this finding in human periodontitis using an epidemiological approach.
sFRP5 and wnt5a concentrations were determined in human serum from the Food Chain Plus cohort using ELISAs. A total of 128 patients with periodontitis and tooth loss and 245 patients with periodontitis without tooth loss were compared to 373 sex-, smoker-, age- and BMI-matched individuals in a nested case-control design.
Systemic sFRP5 serum levels were significantly lower in patients with periodontitis and tooth loss (2.5 [0.0-10.4] ng/ml, median [IQR]) compared to patients with periodontitis without tooth loss (6.0 [2.5-15.8] ng/ml, median [IQR], p = 0.04] and matched controls (7.0 [2.5-18.3] ng/ml, median [IQR], p = 0.02). No significant differences in sFRP5 serum levels were found among patients with periodontitis without tooth loss (6.0 [2.5-15.8] ng/ml, median [IQR]) and controls (3.1 [0.0-10.6] ng/ml, median [IQR], p = 0.06).
sFRP5 might serve as a novel biomarker for periodontitis severity. Modulating the inflammatory background of severe forms of periodontitis, in the time of precision medicine, needs to be revealed in further studies.

This was a national English observational cohort study using administrative data to estimate the effectiveness of community pharmacological and psychosocial treatment for alcohol use disorder (AUD).
All adults commencing AUD treatment in the community reported to the National Drug Treatment Monitoring System (April 1 2014-March 31 2015; N = 52,499). Past 28-day admission drinking pattern included drinks per drinking day (DDD): 0 (\'Abstinent\'), 1-15 (\'Low-High\'), 16-30 (\'High-Extreme\') and over 30 DDD (\'Extreme\'). The primary outcome was successful completion of treatment within 12 months of commencement with no re-presentation (SCNR) in the subsequent six months, analysed by multi-level, mixed effects, multivariable logistic regression.
The majority reported DDD in the \'Low-High\' (n = 17,698, 34%) and \'High-Extreme\' (n = 21,383, 41%) range. Smaller proportions were categorised \'Extreme\' (n = 7759, 15%) and \'Abstinent\' (n = 5661, 11%). Three-fifths (58%) achieved SCNR. Predictors of SCNR were older age, black/minority ethnic group, employment, criminal justice system referral, and longer treatment exposure. Predictors of negative outcome were AUD treatment history, lower socio-economic status, housing problems, and \'Extreme\' drinking at admission. In addition to psychosocial interventions, pharmacological interventions and recovery support increased the likelihood of SCNR. Pharmacological treatment was only beneficial for the \'Low-High\' groups with recovery support.
Over half of all patients admitted for community AUD treatment in England are reported to successfully complete treatment within 12 months and are not re-admitted for further treatment in the following 6 months. Study findings underscore efforts to tailor AUD treatment to the severity of alcohol consumption and using recovery support.