Open Trial Research Articles

The Criminal Offence Of Corruption Of Village Funds (Analysis Of Medan District Court Decision No. 59/Pid.Sus-Tpk/2019 /Pn Mdn)

This research aims to provide an understanding of the legal aspects of Village Fund Corruption. In detail, the objectives to be achieved are to analyze the Legal Regulation of the Crime of Corruption of Village Funds, the process of supervision of Village Funds in an effort to prevent Corruption Crimes in Batu Bara Regency and the Legal Considerations of Judges in Issuing Verdicts on Corruption Crimes of Village Funds in the Decision of the Medan District Court No.59/Pid.Sus-TPK/2019/PN Mdn.This study uses a statutory approach and a case approach in its normative juridical research methodology. The results of the study show that the Criminal Law Regulation on the Crime of Corruption of Village Funds, is contained in Law Number 31 of 1999 jo Law Number 20 of 2001 concerning the Eradication of Corruption Crimes, especially articles 2 and 3. The mechanism for monitoring village funds requires the involvement of all parties, namely the village community, the Village Consultative Body (BPD), the Government Internal Supervisory Apparatus (APIP), and related OPDs. The judge's decision is very important, because in it there is a value that can be in direct contact with human rights. In principle, only the judge's decision that has permanent legal force can be implemented. A decision can be said to have permanent legal force if it is issued through an open and transparent trial and no other legal remedies are submitted. Regulation of Village Fund Corruption is regulated in Law Number 31 of 1999 jo Law Number 20 of 2001 concerning the Eradication of Corruption Crimes articles 2 and 3. In carrying out the supervised supervision of village funds, the involvement of all parties is needed, and the judge's decision is very important, because in it there is a value that can be in direct contact with human rights.

Design of a prototype of clothing for older persons with neurocognitive diseases with behavioural troubles interfering with the management of sphincter disorders

Introduction: The evolution of neurocognitive diseases is marked by increasingly disruptive behavioural disorders as well as sphincter troubles. To avoid being forced to use physical restraints or therapies that promote drowsiness to prevent older patients from removing their diapers, caregivers can use a onesie. However, this solution does not respect the dignity of these persons. Objectives: To design a prototype of onesie that will be aesthetically pleasing as daytime clothing, with features that simplify its use by professional caregivers and respect the dignity of older adults with neurocognitive diseases. Methodology: A randomized open trial was conducted comparing the prototype of onesie that was developed to a classic onesie. The degree of respect for the dignity of these older adults was rated as well acceptability and reliability of the two onesies and a satisfaction survey among caregivers was carried out using a derived questionnaire from the ITHACA project. Results: The final version of the prototype was a onesie resembling to a clothing adapted for day wear and allowing caregivers to quickly change persons with restricted participation. Forty subjects were included. No difference was found in the dignity ratings assigned by their relatives. The caregiver satisfaction survey showed that they thought the prototype respected the dignity of the subjects but that the use of the classic onesie made the work easier. Conclusion: Our prototype of onesie allowed a better usability by caregivers, was better accepted than a classic model of onesie while respecting the dignity of older adults with neurocognitive diseases.

Twenty-Four-Hour Post-Thrombolysis NIHSS Score As the Strongest Prognostic Predictor After Acute Ischemic Stroke: ENCHANTED Study.

This study was conducted to determine optimal predictive ability of National Institutes of Health Stroke Scale (NIHSS) measurements at baseline, 24 hours, and change from baseline to 24 hours after thrombolysis on functional recovery in patients with acute ischemic stroke who participated in the ENCHANTED (Enhanced Control of Hypertension and Thrombolysis Stroke Study). ENCHANTED was an international, multicenter, 2×2 quasifactorial, prospective, randomized open trial of low-dose versus standard-dose intravenous alteplase and intensive versus guideline-recommended blood pressure lowering in thrombolysis-eligible patients with acute ischemic stroke. Absolute (baseline minus 24 hours) and percentage (absolute change/baseline × 100) changes in NIHSS scores were calculated. Receiver operating characteristic curve analyses assessed performance of different NIHSS measurements on 90-day favorable functional recovery (modified Rankin Scale [mRS] score 0-2) and excellent functional recovery (mRS score 0-1). Youden index was used to identify optimal predictor cutoff points. A total of 4410 patients in the ENCHANTED trial were enrolled. The 24-hour NIHSS score had the highest discriminative ability for predicting favorable 90-day functional recovery (mRS score 0-2; area under the curve 0.866 versus 0.755, 0.689, 0.764; P<0.001) than baseline, absolute, and percentage change of NIHSS score, respectively. The optimal cutoff point of 24-hour NIHSS score for predicting favorable functional recovery was ≤4 (sensitivity 66.5%, specificity 87.1%, adjusted odds ratio, 9.44 [95% CI, 7.77-11.48]). The 24-hour NIHSS score (≤3) was the best predictor of 90-day excellent functional recovery (mRS score 0-1). Findings were consistent across subgroups, including sex, race, baseline NIHSS score, stroke subtype, and age. In thrombolysis-eligible patients with acute ischemic stroke, 24-hour NIHSS score (optimal cutpoint of 4) is the strongest predictor of 90-day functional recovery over baseline and early change of NIHSS score. URL: https://clinicaltrials.gov. Unique Identifier: NCT01422616.

Impact of non-invasive oxygen reserve index versus standard SpO2 monitoring on peripheral oxygen saturation during endotracheal intubation in the intensive care unit: Protocol for the randomized controlled trial NESOI2.

In critically ill patients, endotracheal intubation (ETI) is lifesaving but carries a high risk of adverse events, notably hypoxemia. Preoxygenation is performed before introducing the tube to increase the safe apnea time. Oxygenation is monitored by pulse oximeter measurement of peripheral oxygen saturation (SpO2). However, SpO2 is unreliable at the high oxygenation levels produced by preoxygenation and, in the event of desaturation, may not decrease sufficiently early to allow preventive measures. The oxygen reserve index (ORI) is a dimensionless parameter that can also be measured continuously by a fingertip monitor and reflects oxygenation in the moderate hyperoxia range. The ORI ranges from 0 to 1 when arterial oxygen saturation (PaO2) varies between 100 to 200 mmHg, as occurs during preoxygenation. No trial has assessed the potential effects of ORI monitoring to guide preoxygenation for ETI in unstable patients. We designed a multicenter, two-arm, parallel-group, randomized, superiority, open trial in 950 critically ill adults requiring ETI. The intervention consists in monitoring ORI values and using an ORI target for preoxygenation of at least 0.6 for at least 1 minute. In the control group, preoxygenation is guided by SpO2 values recorded by a standard pulse oximeter, according to the standard of care, the goal being to obtain 100% SpO2 during preoxygenation, which lasts at least 3 minutes. The standard-of-care ETI technique is used in both arms. Baseline parameters, rapid-sequence induction medications, ETI devices, and physiological data are recorded. The primary outcome is the lowest SpO2 value from laryngoscopy to 2 minutes after successful ETI. Secondary outcomes include cognitive function on day 28. Assuming a 10% standard deviation for the lowest SpO2 value in the control group, no missing data, and crossover of 5% of patients, with the bilateral alpha risk set at 0.05, including 950 patients will provide 85% power for detecting a 2% between-group absolute difference in the lowest SpO2 value. Should ORI monitoring with a target of ≥0.6 be found to increase the lowest SpO2 value during ETI, then this trial may change current practice regarding preoxygenation for ETI. Trial registration: Registered on ClinicalTrials.gov (NCT05867875) on April 27, 2023.

Effects of Azithromycin on Blood Inflammatory Gene Expression and Cytokine Production in Sarcoidosis

IntroductionIn sarcoidosis granulomas, monocyte-derived macrophages are activated by pro-inflammatory cytokines including TNF and IL-6. Current drug treatment for sarcoidosis aims to suppress inflammation but disabling side effects can ensue. The macrolide azithromycin may be anti-inflammatory. We aimed to determine whether treatment with azithromycin affects blood inflammatory gene expression and monocyte functions in sarcoidosis.MethodsBlood samples were collected from patients with chronic pulmonary sarcoidosis enrolled in a single arm, open label clinical trial who received oral azithromycin 250 mg once daily for 3 months. Whole blood inflammatory gene expression with or without LPS stimulation was measured using a 770-mRNA panel. Phenotypic analysis and cytokine production were conducted by flow cytometry and ELISA after 24h stimulation with growth factors and TLR ligands. mTOR activity was assessed by measuring phosphorylated S6RP.ResultsDifferential gene expression analysis indicated a state of heightened myeloid cell activation in sarcoidosis. Compared with controls, sarcoidosis patients showed increased LPS responses for several cytokines and chemokines. Treatment with azithromycin had minimal effect on blood gene expression overall, but supervised clustering analysis identified several chemokine genes that were upregulated. At the protein level, azithromycin treatment increased LPS-stimulated TNF and unstimulated IL-8 production. No other cytokines showed significant changes following azithromycin. Blood neutrophil counts fell during azithromycin treatment whereas mononuclear cells remained stable. Azithromycin had no detectable effects on mTOR activity or activation markers.ConclusionBlood myeloid cells are activated in sarcoidosis, but azithromycin therapy did not suppress inflammatory gene expression or cytokine production in blood.Trial registration: EudraCT 2019-000580-24 (17 May 2019)

Spillover effects from a type 2 diabetes integrated model of care in 22,706 Australians: an open cohort stepped wedge trial

BackgroundMany Australian adults are not receiving timely or effective diabetes management to prevent or delay the onset of diabetes related complications. Integrated care, a worldwide trend in healthcare reform, aims to reduce the fragmented delivery of health services and improve outcomes. This study aimed to test whether a specialist-led integrated model of care provided to a small subset of patients in general practices leads to spillover clinical improvements in all patients of the practice with type 2 diabetes.MethodsSeventy-two general practice sites (clusters) in New South Wales, Australia received the Diabetes Alliance intervention, creating a non-randomised open cohort stepped wedge trial. The intervention comprised of case conferencing, delivered directly to a small proportion of adults with type 2 diabetes (n = 1,072) of the general practice sites; as well as practice feedback, education and training. Spillover clinical improvements were assessed on all adults with type 2 diabetes within the general practice sites (n = 22,706), using practice level data recorded in the MedicineInsight electronic database, compared before and after the intervention. Outcome measures included frequency of diabetes screening tests in line with the Annual Cycle of Care, and clinical results for weight, blood pressure, HbA1c, lipids, and kidney function.ResultsCompared to before Diabetes Alliance, the odds of all practice patients receiving screening tests at or above the recommended intervals were significantly higher for all recommended tests after Diabetes Alliance (odds ratio range 1.41–4.45, p < 0.0001). Significant improvements in clinical outcomes were observed for weight (absolute mean difference: -1.38 kg), blood pressure (systolic − 1.12 mmHg, diastolic − 1.18 mmHg), HbA1c (-0.03% at the mean), total cholesterol (-0.11 mmol/L), and triglycerides (-0.02 mmol/L) (p < 0.05). There were small but significant declines in kidney function.ConclusionsIntegrated care delivered to a small subset of patients with type 2 diabetes across a large geographic region has spillover benefits that improve the process measures and clinical outcomes for all practice patients with type 2 diabetes.Trial registrationACTRN12622001438741; 10th November 2022, retrospectively registered: https://www.anzctr.org.au/ACTRN12622001438741.aspx.

A Randomized Comparative study of efficacy and safety between %20 and %30 Hydrogen peroxide in the Treatment of Actinic keratosis

Background and objectives: Actinic keratosis is a premalignant skin lesion that presents clinically as a sand-like macule or papule on an erythematous base with a superficial scale due to atypical proliferation of keratinocytes and may progress to squamous cell carcinoma. The aim of this study was to compare the efficacy of hydrogen peroxide in treatment of actinic keratosis between two different concentrations (%20 and %30). Methods: This is a randomized open label therapeutic trial of twenty patients with actinic keratosis has been enrolled, it was conducted from April 2022 to August 2022 at Sulaimaniah dermatology teaching center. Patients were divided to two treatment groups. Hydrogen peroxide %20 applied to the actinic lesions of group A, while group B applied 30% Hydrogen peroxide to the lesions. The solution was applied to the lesions in a circular motion for 20 seconds, for four rounds per session Patients were seen after a first session in two weeks. Maximum four sessions spaced out by 15 days are given until clearance. Result: we conducted a randomized open label therapeutic trial. It was conducted from April 2022 to August 2022 at Sulaimaniah dermatology teaching center. Regarding response in Group A out of twenty actinic lesions, marked and moderate improvement was recorded in %40, %30 of the lesions respectively while the remaining lesions %30 of them showed slight improvement and no clinically clearance has been recorded. In comparsison, Group B out of twenty lesions %60 of them clinically cleared and slight improvement was recorded only in %20 of lesions. There were statistically significant differences between (20% &amp; 30% Hydrogen peroxide ) in response (p-value=0.000). Regarding side effects; majority of patients (85%) in both groups had recorded burning sensation, irritation and transient erythema, while no scarring, pigmentation, atrophy has been recorded. There were no statically significant differences between two groups. Conclusion: Hydrogen peroxide can be used as safe, alternative method to other modalities in treatment of actinic keratosis lesions, results would be better if higher concentration %30 used

A prospective, randomized, controlled, interventional clinical trial to evaluate the safety and efficacy of the medical monopoint reperfusion system for aspiration thrombectomy in acute ischemic stroke patients (SUMMIT MAX): Trial rationale and design.

Treatment of large vessel occlusion (LVO) using mechanical thrombectomy with or without intravenous thrombolysis has demonstrated better outcomes compared to medical treatment alone. Large-bore aspiration catheters have been recently introduced. Their effectiveness and safety have not been demonstrated in a randomized trial. The SUMMIT MAX study is designed to address this question. SUMMIT MAX is a randomized controlled trial where the effectiveness and safety of the large-bore Monopoint Reperfusion system (Route 92 Medical, San Mateo, CA), will be compared to the currently largest available FDA-cleared aspiration thrombectomy device the AXS Vecta Aspiration system (Stryker Neurovascular, Fremont, CA). The study is a multi-center, prospective, randomized, controlled, interventional, open label clinical trial. The hypothesis is that the effectiveness measured by the recanalization rate (modified thrombolysis in cerebrovascular infarction - mTICI) and safety measured by symptomatic intracranial hemorrhage rate (sICH) of the medical monopoint reperfusion system is non-inferior to the AXS Vecta Aspiration system. Up to 250 subjects are enrolled with at least 50% of subjects enrolled by US sites. The primary effectiveness endpoint is successful arterial revascularization defined as an mTICI score ≥ 2b after use of the assigned device adjudicated by an independent core lab. The primary safety endpoint is defined as sICH within 24 h (-8/+24) post-procedure. Secondary endpoints include successful arterial revascularization defined as a mTICI score ≥ 2b after use of the assigned device with or without adjunctive therapy; device-related serious adverse events; all asymptomatic hemorrhages; time from groin puncture to final angiogram; and rate of first pass effect defined as mTICI 2b after first pass with the assigned device stratified by age (≤85, ≥ 86). SUMMIT MAX is a randomized controlled trial comparing the effectiveness and safety of a new large bore class of aspiration devices to the currently largest FDA-cleared aspiration device available.

The efficacy, safety, and satisfaction of telehealth-delivered hypnotic cognitive therapy for chronic pain in spinal cord injury: A pilot study with historical controls

Context/Objective In-person hypnotic cognitive therapy (HYP-CT) is a promising treatment for chronic spinal cord injury-related pain. We describe the effects of HYP-CT delivered via Zoom (Z-HYP-CT) and compare the effects to historical controls who received hypnosis, cognitive therapy, or HYP-CT in-person. Design Open pilot trial of HYP-CT versus historical controls. Setting Telehealth study that recruited people with chronic SCI. Participants Adults with moderate to severe chronic SCI-related pain. Interventions Four weekly sessions of HYP-CT delivered via Zoom. Outcome measures The primary outcome was average pain intensity on a 0–10 numerical rating scale measured at end of treatment (4 weeks) and 12 weeks. Secondary outcomes included pain interference, depression, sleep, pain catastrophizing, and pain self-efficacy. Results 23 individuals with SCI-related pain participated in the open trial and were compared to 21 historical controls. Average age was 54 years, 70% were male, and the majority were White. The participants were 11.6-13.1 years post-SCI and average pain intensity was 4.8-5.4/10. After Z-HYP-CT mixed-effects linear regressions showed that pain intensity was significantly less at 4 weeks (−1.28, P < .0001) and 12 weeks (−1.50, P < .0001) relative to baseline. Pain interference, depression, and pain catastrophizing also decreased significantly at both time points. There were no significant differences between the effects of Z-HYP-CT versus historical controls on any outcome variable. Conclusion HYP-CT delivered via telehealth was associated with reduced pain intensity and other benefits that were comparable to the effect achieved by in-person historical controls. The effects of Z-HYP-CT should be evaluated using a randomized controlled design.

A Natural Astragalus-Based Nutritional Supplement Lengthens Telomeres in a Middle-Aged Population: A Randomized, Double-Blind, Placebo-Controlled Study.

Telomeres are ribonucleoprotein structures that form a protective buffer at the ends of chromosomes, maintaining genomic integrity during the cell cycle. A decrease in average telomere length is associated with with age and with aging-related diseases such as cancer and cardiovascular disease. In this study, we conducted a randomized, double-blind, placebo-controlled trial over six months to compare the effects of the Astragalus-based supplement versus a placebo on telomere length (TL) in 40 healthy volunteers (mean age 56.1 ± 6.0 years). Twenty subjects received the supplement, and 20 received placebo capsules. All participants completed the study, and no adverse side effects were reported at six months. Subjects taking the Astragalus-based supplement exhibited significantly longer median TL (p = 0.01) and short TL (p = 0.004), along with a lower percentage of short telomeres, over the six-month period, while the placebo group showed no change in TL. This trial confirmed that the supplement significantly lengthens both median and short telomeres by increasing telomerase activity and reducing the percentage of short telomeres (<3 Kbp) in a statistically and possibly clinically significant manner. These results align with a previous open prospective trial, which found no toxicity associated with the supplement's intake. These findings suggest that this Astragalus-based supplement warrants further investigation for its potential benefits in promoting health, extending life expectancy, and supporting healthy aging.

Screening log: Challenges in community patient recruitment for gynecologic oncology clinical trials

BackgroundClinical trial participation can improve overall survival and mitigate healthcare disparities for gynecologic cancer patients in low-volume community centers. This study aimed to assess the effectiveness of a centrally regulated but administratively decentralized electronic screening log system to identify eligible patients across a large catchment area for a National Cancer Institute (NCI)-designated cancer center's open clinical trials. MethodsElectronic screening log data collected between 2014 and 2021 from ten community partner sites in a single NCI-designated cancer center's catchment area were reviewed retrospectively. Clinical factors assessed included cancer site, primary versus recurrent disease status, and histology. Identification efficiency (the ratio of patients screened identified with an available trial) was calculated. Identification inefficiencies (failures to identify patients with a potentially relevant trial) were assessed, and etiologies were characterized. ResultsAcross ten community partner sites, 492 gynecologic cancer patients were screened for seven open clinical trials during the study period. This included 170 (34.5 %) ovarian cancer patients, 156 (31.7 %) endometrial cancer patients, and 119 (24.2 %) cervical cancer patients. Over 40 % had advanced stage disease, and 10.6 % had recurrent disease. Only three patients were identified as having a relevant open trial; none ultimately enrolled due to not meeting trial eligibility criteria. An additional 2–52 patients were retrospectively found to have a relevant trial available despite not being identified as such within the electronic screening log system. Up to 14.4 % of patients had one or more missing minimum data elements that hindered full evaluation of clinical trial availability. Re-screening patients when new trials open may identify 12-15 additional patients per recurrent disease trial. ConclusionsAn electronic screening log system can increase awareness of gynecologic oncology clinical trials at a NCI-designated cancer center's community partner sites. However, it is inadequate as a single intervention to increase clinical trial enrollment. Providing adequate support staff, documenting clinical factors consistently, re-screening patients at relevant intervals, and coordinating with central study personnel may increase its utility.

Effectiveness of Imagery Rescripting for Trauma-Affected Voice Hearers: An Open Trial.

People who hear voices (auditory verbal hallucinations) often have post-traumatic stress disorder (PTSD) symptoms. Cognitive behavioural therapies (CBT) have yielded inconsistent findings when treating voices and PTSD symptoms in voice hearers. Preliminary evidence suggests imagery rescripting (ImRs) is associated with large reductions in voice hearing and PTSD symptoms. This study replicated past studies using a larger sample to examine the effectiveness of ImRs in reducing such symptoms. Participants (N = 49; 65.3% female; Mage = 35.86) were clients at an Australian transdiagnostic clinic for voice hearers. A one-arm open trial design was used with three pre-treatment baselines and a mid-treatment, post-treatment and 3-month follow up assessments of PTSD symptoms (Posttraumatic Diagnostic Scale for DSM-5), voices (Hamilton Program for Schizophrenia Voices Questionnaire) and emotional symptoms (Depression Anxiety and Stress Scales-21). Five single-item measures were administered weekly to explore the trajectories of change in trauma intrusions, voice-related distress, voice frequency and positive and negative voice valance. ImRs was associated with very large reductions in PTSD symptoms and voices (both emotional and physical characteristics of voices) and emotional symptoms at post-treatment and follow-up (η2 p = 0.24-0.44). There were medium-large to large reductions in weekly symptoms of intrusions, voice-related distress, voice frequency and negative voices (η2 p = 0.12-0.16) and a non-significant increase in positive voices (η2 p = 0.05). This study provides further evidence that ImRs is an effective treatment for voices and PTSD symptoms in voice hearers with a range of diagnoses. Randomised controlled trials are needed to compare the efficacy of ImRs to CBT protocols.

Comparing Ribociclib versus Palbociclib as a Second Line Treatment in Combination with Fulvestrant in Metastatic Breast Cancer: A Randomized Clinical Trial.

Assessment of CBR, PFS, QOL and toxicity profile of palbociclib and ribociclib. This is an interventional concurrent randomised phase III open label clinical trial. It took place at the Oncology Centre Mansoura University, Egypt from July 2022 till December 2023. Patients with pathologically proved ER+ HER2- metastatic breast cancer who either progressed on adjuvant hormonal or progressed on 1st line hormonal for metastatic disease. Patients in arm A received palbociclib 125 mg/day orally for 3 weeks and 1 week rest, plus fulvestrant. Patients in Arm B received ribociclib at a dose of 600 mg, administered orally once daily for 3 weeks and 1 week rest, plus fulvestrant. Pre- and peri-menopausal women received the LHRH agonist goserelin. Patients who lost their endorsement and were considered to be lost to follow up. Quality of life was analysed using the (EORTC) quality-of-life questionnaire (QLQ)-C30 V3.0. Patients were asked to complete the questionnaires at screening; at the 2nd and 6th month. Toxicity was assessed and graded using (CTCAE) v5.0. Patients were evaluated clinically for response and toxicity monthly and radiologically by CT and tumor markers/ 3 months. Treatment continued until objective Progressive Disease (PD), symptomatic deterioration, unacceptable toxicity or death. Both arms had similar baseline characteristics. There was no statistically significant difference regarding the CBR (58.6% for both arms at 6 months and 13.8% in the palbociclib VS 17.2% in the ribociclib arm at 12 months). The median PFS to the whole population was 13 months. COX multivariate analysis revealed that postmenopausal had 2.85 more likely to survive than premenopausal patients. Patients with ECOG performance status 2 and 3 are 0.13 and 0.39 less likely to survive compared to patients with PS 1. Dose reduction increased the likelihood of survival 3.36 compared with no dose reduction. The median PFS was 13.67 months in the palbociclib arm and 12.69 months in the ribociclib arm with no statistically significant difference. During follow up, there was statistically significant improvement in insomnia in both arms and constipation in the palbociclib arm alone. Comparing the two arms, no statistically significant deterioration in the QOL domains except in fatigue and financial difficulties, with more deterioration in the palbociclib arm. Regarding common toxicities there was no statistically significant difference between the 2 arms. Both Ribociclib and palbociclib have similar CBR, PFS and toxicity profile.

Homeopathy in Lymphatic Filariasis: A Narrative Review

AbstractLymphatic filariasis (LF) is globally considered a neglected tropical disease (NTD), as well as the second leading cause of disability. The financial and social burden of LF is significant and has an impact on the patient's ability to work, participate in social activities, and raise a family. Diethylcarbamazine (DEC), an antifilarial medication, is currently the preferred treatment for LF. However, its use can have some short-term adverse events. So, the effective management of LF is the need of the hour for preventing disease progression and episodes of acute adenolymphangitis. This article attempts to review the available literature on homeopathic intervention, which is an alternative, cost-effective and safer therapeutic option in the treatment of LF. A comprehensive search was made for studies conducted from 1980 to 2019 in different databases and resources, including PubMed, ScienceDirect, and Google Scholar. In addition, a manual search of monographs and research studies of the Central Council for Research in Homoeopathy (CCRH) related to filariasis was conducted through the AYUSH Research Portal, Archive on Homoeopathy, and CCRH e-library. According to study design, aims and objectives, sample size, study duration, intervention, outcome parameters, and results, the literature that is currently accessible has been categorized. Out of 15 studies screened, 8 related to homeopathy on LF were selected for this review. Of these, 1 randomized open label comparative trial, 2 single-blind nonrandomized placebo-controlled trials, 4 single-arm interventional trials, and 1 retrospective observational study were found. Except one single blind placebo-controlled nonrandomized study, the outcomes of other studies were found to be in favor of homeopathy. The review shows that there may be some beneficial effects of homeopathy in the management of LF. However, there are inconsistencies, gaps in the study, and insufficient outcome measures in the included literatures, which make it impossible to draw any firm conclusions. Subsequent research endeavors ought to surmount these challenges and conform to enhanced research design and methods.

The effects of Lactobacillus plantarum PS128 in patients with major depressive disorder: an eight-week double-blind, placebo-controlled study

Major depressive disorder (MDD) is a complex mental disorder, potentially linked to the gut-microbiota-brain axis. Probiotics like Lactobacillus plantarum PS128 (PS128) may improve depressive symptoms by modulating the gut microbiota based on our previous open trial. We conducted an 8-week double-blind, placebo-controlled trial to investigate the impact of PS128 on depression severity, markers of inflammation and gut permeability, and the gut microbiota composition in 32 patients with MDD with stable antidepressant treatment but moderate symptom severity. Following the 8-week intervention, both the Hamilton Depression Rating Scale-17 score (HAMD), and Depression and Somatic Symptoms Scale (DSSS) showed a significant decrease in both groups (p<0.001). However, there was no significant difference in the change of depression severity between groups (p=0.203). Moreover, alterations in serum levels of high sensitivity C-reactive protein, interleukin-6, tumor necrosis factor-α, and intestinal fatty acid binding protein, as well as changes in the gut microbiota composition, did not exhibit significant differences before and after intervention or between the groups. In comparison to the placebo group, our study did not find significant effects of PS128 on depressive symptoms, biomarkers of inflammation and gut permeability, and the overall gut microbiota composition. Nonetheless, we observed a potential impact of PS128 on the symbiosis of specific taxa. To comprehensively understand the psychophysiological effects of PS128 in patients with MDD, further research with a larger sample size is imperative.

Feasibility study of a telehealth school-based behavioral parent training group program for attention-deficit/hyperactivity disorder.

To evaluate the feasibility and preliminary efficacy of Telehealth Behavioral Parent Training (T-BPT), a school telehealth group intervention for attention-deficit/hyperactivity disorder (ADHD) with a companion training program for school clinicians. T-BPT was developed in an iterative three-phase design in partnership with community stakeholders during the COVID-19 pandemic. School clinicians (N = 4) delivered T-BPT over 8 weeks to parents (N = 21, groups of 5-6 per school) of children (Grades 2-5) with ADHD while simultaneously receiving training and consultation from PhD-level study trainers. A single-arm open trial was used to assess feasibility, engagement, and preliminary efficacy. Parents and school clinicians endorsed high feasibility, acceptability, and usability of T-BPT. Parent attendance was high (M = 94.6%) and a majority of parents (66.7%) attended all eight sessions. Preliminary outcomes indicate moderate to large reductions in parent-reported ADHD symptoms (ω2 = .36), functional and clinical global impairment (ω2s= .21 and .19, respectively), and distance learning challenges (ω2 = .22). Results were in line with in-person delivery, indicating promising feasibility of school telehealth BPT groups. This study also provided further support for the feasibility of the remote training model for school clinicians. Implications of the commonly endorsed barriers and benefits beyond COVID-19 and relevance to under resourced communities are also discussed.

Does response to treatment differ between anorexia nervosa and atypical anorexia nervosa? Findings from two open series trials

BackgroundNo evidence-based treatments exist for atypical anorexia nervosa (AAN) and little is known about differences in response to treatment between anorexia nervosa (AN) and AAN. The purpose of this paper is to explore treatment outcomes in two pilot trials for those with AN and AAN. MethodsStudy 1 (N = 127) examined treatment outcomes in a digital imaginal exposure trial and Study 2 (N = 34) examined outcomes in a personalized treatment trial. Participants with an active eating disorder (ED) were eligible and those with AN or AAN were included in these analyses. ED symptoms and ED-related fears were assessed at pre-treatment, post-treatment, and one and six-month follow-up. Linear mixed effects models explored treatment outcomes by diagnosis. ResultsThere were no significant differences in treatment response between diagnoses for most outcome measures. In Study 2, participants with AAN had a significant decrease in global ED symptoms across time, while AN did not. LimitationsThe samples were primarily white and female, limiting the generalizability of the studies. Additionally, due to limited consensus on “significant weight loss,” a less conservative definition was used to diagnose AAN which may impact the results. ConclusionsIn general, those with AN and AAN may respond to treatment similarly, with some small differences. Digital exposure therapy may be effective treatments for both AN and AAN, especially for ED-related fears. Personalized treatment may be more effective for those with AAN than those with AN.

Harm reduction-focused behavioral activation for people who inject drugs: Mixed methods outcomes from a pilot open trial

IntroductionPeople who inject drugs (PWID) experience high rates of mental health problems and drug-related harms. Harm reduction-focused interventions aim to reduce harms associated with drug use and are an important approach for engaging people who are not seeking traditional abstinence-focused treatment. Yet, few studies to date have examined the effectiveness of harm reduction psychosocial treatment for drug use. We evaluated the outcomes of a harm reduction-focused behavioral activation (BA) intervention from pretreatment to a 1-month follow-up. MethodsA total of N = 23 PWID (65.2 % White; 52.2 % women; mean age 35.4 ± 7.8 years) were recruited from syringe services programs and n = 19 received the intervention via teletherapy. Assessment of study outcome measures occurred at pre- and posttreatment and a one-month follow-up. ResultsResults reflected post-intervention increases in behavioral activation and readiness to change drug use, as well as decreases in substance use, depression, and HIV risk behaviors. There were mixed outcomes on substance-related problems with increases at follow-up, possibly reflecting increased problem recognition. ConclusionsThese results suggest initial promise for the harm reduction-focused treatment. Additional research with randomized designs and larger sample sizes is needed, and more intensive treatment may be required to support sustained treatment gains in this population.

Impact of Rice Bran Oil Emulsified Formulation on Digestion and Glycemic Response to Japonica Rice: An In Vitro Test and a Clinical Trial in Adult Men.

To assess the effect of rice bran oil emulsified formulation (EMF) on cooked rice, a single-arm open clinical trial and in vitro testing for digestion and glycemic response were performed. Fifteen Japanese men consumed 200 g of packed rice, cooked with or without EMF. Blood samples were collected 0, 30, 60, and 120 min post-consumption and analyzed for glucose, insulin, and triglyceride levels. Continuous glucose monitoring (CGM) and sensory evaluation were also performed. A two-step in vitro digestion test, simulating gastric and small intestinal digestion was conducted. EMF-added rice group showed higher insulin response levels at 60 min than the placebo group. Stratification of participants with HbA1c ≥ 5.6 or an insulinogenic index ≤ 0.4 revealed a significant reduction in Cmax glucose levels. A significant correlation was observed between venous and CGM blood glucose levels and no significant sensory differences were observed. The in vitro test revealed significantly lower C∞, equilibrium starch concentrations, with EMF. Clinical trial suggests that EMF may stimulate insulin secretion and reduce blood glucose levels in participants with lower insulin responses. In vitro tests suggest that EMF inhibits glycemic digestion. This trial was registered at the UMIN Center (UMIN000053495; registered 31 January 2024).

“It changed me for the better”: Feasibility, acceptability, and safety of an online program for sexual and gender minority youth to prevent alcohol use and teen dating violence

ObjectiveThe purpose of the current study was to describe and present implementation outcome data from an open pilot trial of the Promoting Resilient Youth with Strong Hearts and Mind (PRYSHM) Program, an online, live-facilitated, nine-session group program for dating sexual and gender minority youth (SGMY) ages 15 to 18. The program, co-facilitated by two LGBTQIA2S+ adults, focuses on reducing proximal forms of minority stress and building LGBTQIA2S+ community in addition to providing evidence-based teen dating violence (TDV) and alcohol use (AU) prevention components. MethodParticipants (recruited via social media) included 18 SGMY (ages 15 to 17) from across the U.S. who completed a baseline survey and immediate post-test, as well as post-session surveys following each of the nine sessions. Sessions were recorded to monitor fidelity and facilitation skills. ResultsThe intervention was highly acceptable, and the program was perceived to be relevant and impactful, as evidenced by SGMY agreeing or strongly agreeing to items assessing these domains. Further, fidelity was 82.4% (average) across sessions, and the average attendance was 6.50 out of 9 sessions. SGMY also provided open-ended feedback used to revise the PRYSHM program for future implementation and evaluation research. ConclusionThese data provide preliminary support for PRYSHM as a feasible, acceptable, and safe prevention program and suggest that further evaluation of the program using larger samples and rigorous outcome evaluation methods is warranted.