Non-randomized Pilot Study Research Articles

Self-Cross-Linked Hyaluronic Acid Gel for Adhesion Prophylaxis in Laparoscopic Deep Endometriosis Removal: Safety Report of a Prospective Pilot Study

Background/Objectives: Surgical removal of deep endometriosis lesions is an established method of reducing patient symptoms, but it often results in iatrogenic adhesions that lead to further problems. This pilot study presents the safety evaluation of a novel self-cross-linked hyaluronic acid gel used to reduce adhesions after non-bowel deep endometriosis surgery. Methods: A single cohort, single-center, non-randomized pilot study was conducted in patients diagnosed with non-bowel deep endometriosis who underwent a three-stage treatment regimen consisting of first surgery, hormone therapy and second surgery. The present report is limited to an analysis of the inflammatory parameters, pain and complications occurring within a 72 h period following the initial laparoscopy (FLL) utilizing the anti-adhesion gel. Results: 60 patients (28.48 ± 5.9 years old) were included. 24 h after the intervention, a slight elevation in C-reactive protein levels was observed in 38.33% of cases (0.98 ± 1.46 mg/dL), with a statistically significant difference after FLL (0.98 ± 1.46 mg/dL before FLL vs. 1.03 ± 1.29 mg/dL after FLL; p =< 0.001); there were no patients with levels above 10 mg/dL before or after surgery. 24 h after FLL, 29.33% of patients had a leukocyte count greater than 11 Thous/μL, with a maximum observed value of 16.2 Thous/μL. The count was found to be statistically significantly higher after FLL (6.03 ± 1.91 Thous/μL before FLL vs. 9.15 ± 2.61 Thous/μL after FLL; p =< 0.001). At 72 h post-intervention, postoperative pain was reported in up to 63.33% of cases, and one urinary tract infection with fever occurred but was not considered to be related to the product. No serious adverse events were observed. Conclusions: The results of this exploratory study showed a safe range of inflammatory response within a 24 h period following the application of the novel self-cross-linked hyaluronic acid antiadhesion gel (HyaRegen®) in patients who underwent laparoscopic surgery for non-bowel deep endometriosis.

Fostering social-emotional competencies to improve social functioning, social inclusion, and school well-being: Results of a cluster non-randomized pilot study

BackgroundThe development of social competencies is key for enhancing both cognitive and non-cognitive skills among students. These competencies are central to students' ability to function socially, feel included, and experience overall well-being within the school environment. Schools can play an active role in promoting and shaping these outcomes by implementing various strategies. This study presents and reports on the outcomes of a six-week social-emotional intervention program implemented by class teachers. MethodsThe pilot study employed a two-arm cluster non-randomized trial with a pretest-post-test design. The study evaluates students' social competencies as the primary outcome and social functioning, social inclusion, and school well-being as the secondary outcomes. Students in the intervention group participated in a six-week social-emotional learning intervention, attending two sessions each week, while the control classes followed the regular curriculum. ResultsData were collected from both teachers and students. Student-reported data were collected from 266 students (n = 124 girls, n = 142 boys) aged 8 to 14 (M = 9.84) and from teachers on 212 students (n = 92 girls; n = 115 boys). Results of the linear mixed model analysis showed for teacher reporting on students’ outcomes a decrease in internalizing (β = -0.85, p = 0.035) and externalizing behavior problems for students in intervention classes (β = -6.84, p = 0.020). No significant changes were observed in social-emotional competencies, social inclusion and school well-being. ConclusionAfter the social-emotional intervention program reduced internalizing and externalizing behavior problems were observed, with age moderating both outcomes. The results are consistent with previous research; however, they also suggest that the intervention could benefit from adjustments, such as a longer implementation period and follow-up evaluation. External factors such as the COVID-19 pandemic and repeated school closures at the time of the study may have impacted the results additionally.

A Nonrandomized Pilot Study to Investigate the Acceptability and Feasibility of LivR Well: A Multifaceted 28-Day Home-Based Liver Optimization Program for Acute-on-Chronic Liver Failure

Background and AimsAcute-on-chronic liver failure (ACLF) has a 22-74% 28-day mortality rate and 30-40% 30-day re-admission rate. We investigated the acceptability and feasibility of a multimodal community intervention for ACLF. MethodsA single-arm, non-randomized pilot study of consecutive participants with ACLF was conducted in a tertiary health service. Participants received weekly medical and nursing reviews, dietetics, physiotherapy, pharmacy, social work, addiction medicine, and/or neuropsychiatry. A digital platform included remote weight monitoring, and online surveys. The primary outcome was acceptability/feasibility. Secondary outcomes included safety, mortality, re-admission, liver disease severity, and costs. ResultsFifty-nine patients were enrolled with median age 51 years (IQR: 45-59); majority alcohol etiology (74%),and median Model for End-Stage Liver Disease Sodium (MELD-Na) score 16 (IQR: 12-21). LivR Well was acceptable with low attrition (8/59), adherence to the program including home visits (mean 8.4±4.2) and consultations (mean 2.4±1.5) per patient. This was supported by positive feedback and themes identified through a qualitative sub-analysis. Feasibility was demonstrated by recruitment rate of 4.94 patients/month and 86% completion. Mortality was lower than expected at 3%, 30-day readmission rate was 15%, and median MELD-Na score reduced to 15 (p = 0.01). Median 6-month costs reduced from $30,454 (IQR: 21953-$65657) to $17, 657 ($4249-42876) (p=0.009). The total 6-month healthcare cost was $1,868,859 (95% CI 1,081,821-2,655,897) compared to $2,518,227 (95% CI 1,959,610-3,076,844). ConclusionLivR Well was acceptable, feasible and safe with low short-term mortality and readmission rates. Healthcare costs were reduced by 26% driven by a 40% reduction in 30-day re-admission. Further evaluation includes a randomized, controlled trial of LivR Well compared to standard care.

Supporting primary care practitioners to promote dementia risk reduction in Australian general practice: outcomes of a cross-sectional, non-randomised implementation pilot study.

Background Primary care practitioners worldwide are urged to promote dementia risk reduction as part of preventive care. To facilitate this in Australian primary care, we developed the Umbrella intervention, comprising a waiting room survey and patient information cards for use in consultations. Educational and relational strategies were employed to mitigate implementation barriers. Methods In this cross-sectional, non-randomised implementation study within the South East Melbourne Primary Health Network, we employed mixed-methods outcome evaluation. Antecedent outcomes (acceptability, appropriateness, and feasibility) and actual outcomes (adoption, penetration, and fidelity) were assessed from the perspective of primary care practitioners and patients. Results Five practices piloted the intervention and implementation strategies, including 16 primary care practitioners engaging with 159 patients. The Umbrella intervention was deemed acceptable, appropriate, and feasible, but penetration was limited. Approximately half of eligible primary care practitioners used the intervention, with moderate fidelity. Engagement with implementation strategies was similarly limited. While most strategies were well-received, improvements in online peer discussions and staff readiness were desired. Conclusions The Umbrella intervention is a viable approach to promoting dementia risk reduction in Australian general practice, supported by educational and relational strategies. Stakeholder-informed refinements to enhance uptake are recommended before advancing to a definitive trial.

Internet-based cognitive behavioral therapy for individuals with gambling disorder in Indonesia: protocol for a pilot and feasibility study.

Gambling disorder (GD) has become a wide concern in Indonesia, as many negative consequences arise from this psychiatric condition. Prompt treatment with an appropriate method of delivery is required to achieve optimal outcomes in GD patients. This protocol paper outlines a study to determine the effectiveness, acceptability, and feasibility of internet-based cognitive behavioral therapy (iCBT) in treating GD in Indonesia. This non-randomized pilot and feasibility study will recruit 20 people with GD. All participants will receive the iCBT intervention through self-learning videos and guided weekly group sessions. The effectiveness of the intervention will be assessed at baseline (week 0), post- treatment completion (week 10), and 6 weeks post-treatment (week 16). The outcomes measured will be the change in gambling symptoms, gambling urges, cognitive distortions, readiness to change, emotional problems, and quality of life of the participants. The feasibility of iCBT for GD patients in Indonesia will be assessed by this study. The study's results will give an indication of the acceptability of the intervention and the feasibility of a subsequent conclusive trial. The delivery of iCBT may help to address the issue of treatment access in an extensive geographical region and provide immediate implications as a treatment resource for GD in practice.

Erosion regression in patients with rheumatoid arthritis after upadacitinib-a pilot study using high resolution peripheral quantitative computed tomography.

To evaluate whether inhibition of Janus kinases (JAK) 1 could lead to erosion repair on high-resolution peripheral quantitative computer tomography (HR-pQCT) in patients with active rheumatoid arthritis (RA). This was a prospective, non-randomized pilot study. We enrolled 20 adult patients with active RA with ≥1 bone erosion on HR-pQCT. They were given upadacitinib 15 mg once daily for 24 weeks. HR-pQCT of the metacarpophalangeal joint was performed at baseline and 24-week. The serum bone biomarkers level was evaluated before and after treatment. Twenty age-and-sex matched RA patients from another study treated with conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) were included as active controls. Nineteen patients in the upadacitinib group completed the study procedures. After 24 weeks, despite similar improvement in disease activity, a reversed trend in the mean erosion volume change on HR-pQCT was observed comparing the upadacitinib and active control group (upadacitinib group: -0.23 ± 3.26mm3 vs control group: 1.32 ± 6.05mm3, p= 0.131). A greater proportion of erosions in the upadacitinib group demonstrated regression (27% vs 12%, p= 0.085). Using general estimating equation (GEE), the use of upadacitinib was significantly associated with erosion regression (OR: 3.61, 95% CI: 1.00-13.00, p= 0.049) after adjusting for the difference in disease duration. The serum levels of bone resorption markers reduced after upadacitinib treatment. No new safety signal was noted. Despite a similar improvement in RA disease activity after upadacitinib compared with csDMARDs, a differential regression of erosion on HR-pQCT was observed in patients received upadacitinib. The potential role of JAK1 inhibition in erosion repair should be investigated.

Intravenous Lidocaine for Refractory Pain in Patients With Pancreatic Ductal Adenocarcinoma and Chronic Pancreatitis: A Multicenter Prospective Nonrandomized Pilot Study.

Refractory pain is a major clinical problem in patients with pancreatic ductal adenocarcinoma (PDAC) and chronic pancreatitis (CP). New, effective therapies to reduce pain are urgently needed. Intravenous lidocaine is used in clinical practice in patients with PDAC and CP, but its efficacy has not been studied prospectively. Multicenter prospective nonrandomized pilot study included patients with moderate or severe pain (Numeric Rating Scale ≥ 4) associated with PDAC or CP in 5 Dutch centers. An intravenous lidocaine bolus of 1.5 mg/kg was followed by continuous infusion at 1.5 mg/kg/hr. The dose was raised every 15 minutes until treatment response (up to a maximum 2 mg/kg/hr) and consecutively administered for 2 hours. Primary outcome was the mean difference in pain severity, preinfusion, and the first day after (Brief Pain Inventory [BPI] scale 1-10). A BPI decrease ≥1.3 points was considered clinically relevant. Overall, 30 patients were included, 19 with PDAC (63%) and 11 with CP (37%). The mean difference in BPI at day 1 was 1.1 (SD ± 1.3) points for patients with PDAC and 0.5 (SD ± 1.7) for patients with CP. A clinically relevant decrease in BPI on day 1 was reported in 9 of 29 patients (31%), and this response lasted up to 1 month. No serious complications were reported, and only 3 minor complications (vertigo, nausea, and tingling of mouth). Treatment with lidocaine did not impact quality of life. Intravenous lidocaine in patients with painful PDAC and CP did not show an overall clinically relevant reduction of pain. However, this pilot study shows that the treatment is feasible in this patient group and had a positive effect in a third of patients which lasted up to a month with only minor side effects. To prove or exclude the efficacy of intravenous lidocaine, the study should be performed in a study with a greater sample size and less heterogeneous patient group.

Comparing the effects of resistance and aerobic exercise on mood-related symptoms and EEG activity in young healthy adults: A non-randomized pilot study

Background and aimsExercise offers several benefits in combating mood-related symptoms in humans. Participation in various types of physical activity improves brain and mental health. However, the different effects and mechanisms depending on the type of exercise on an individual's mood and brain remain unclear. This pilot trial aimed to reveal the feasibility of the effects of resistance and aerobic exercise on mood-related symptoms and explain the different patterns of brain waves. MethodsThis 15-week single-arm pre-test/post-test trial including 3 measurement periods was held in Seoul, Republic of Korea. Overall, 18 healthy participants aged 19–29 years were recruited. After 6 weeks of respective aerobic and resistance exercise, anxiety/depression-related questionnaire scores and electroencephalography (EEG) changes were measured (single blinded outcome assessment). Specifically, changes in frontal alpha asymmetry (FAA), absolute band power of beta waves, and theta waves were measured in the prefrontal and frontal regions, which play a critical role in regulating mood and cognition. ResultsResistance exercise resulted in a significant reduction in Beck Depression Inventory-II scores (p = 0.002, effect size = 0.76) while significant improvement was shown in Beck Anxiety Inventory scores (p = 0.01, effect size = 0.77) after aerobic exercise. In regarding EEG analysis, ten participants completed the assessment. After resistance exercise, there was a significant elevation in frontal beta waves (p = 0.01, effect size = 0.81). Aerobic exercise did not result in significant EEG changes. There were no adverse events related to study participation. ConclusionOur findings suggest that resistance and aerobic exercises may be feasible for the alleviation of mood-related symptoms and EEG activities. As our pilot trial has a small sample size and did not include a control group, future research that accurately reflects the effects of different types of exercises on mood symptoms and changes of EEG activities is required.

Acute toxicities in proton therapy for head and neck cancer – A matched analysis of the DAHANCA 35 feasibility study

Background and purposeAs preparation for a national randomized study comparing proton radiotherapy to photon radiotherapy, DAHANCA 35, we performed a non-randomized pilot study to investigate patient selection, logistics, planning, and treatment delivery. With the present study, as a comprehensive safety analysis, we want to compare toxicity during and up to two months after therapy to a historically matched group of patients treated with photon radiotherapy. Materials and methods62 patients treated with protons were matched to 124 patients who received photon treatment outside a protocol. Available data were retrieved from the DAHANCA database. Patients were matched on treatment centre, concurrent chemotherapy, tumour site, stage, p16 status for oropharynx cancers. Selection of patients for proton therapy was based on comparative treatment plans with a NTCP reduction for dysphagia and xerostomia at six months. ResultsBaseline characteristics between groups were well balanced, except for the type of drug used concurrently; more photon patients received Carboplatin (21.2 % vs 5.8 %, p = 0.01). Proton therapy was associated with significantly less weight loss at the end of treatment, mean weight loss of 3 % for protons and 5 % for photons (p < 0.001). There were more grade 3 skin reactions and grade 3 mucositis after proton treatment compared with photons at the end of treatment, Risk Ratio (RR) 1.9 (95 % CI: 1.01–3.5, p = 0.04) and RR 1.5 (95 % CI: 1.3–1.7, p < 0.001), respectively. All differences resolved at follow up two months after treatment. There were no significant differences between groups on opioid use, use of feeding tubes, or hospitalization during the observation period. ConclusionProton treatment resulted in excess objective mucositis and dermatitis, which was transient and did not seem to negatively influence weight or treatment compliance and intensity. Selection bias was likely especially since NTCP models were used for selection of proton treatment and photon treated patients were matched manually. We are currently including patients in a randomized controlled trial.

In-person psychoeducational intervention to reduce rehospitalizations and improve the clinical course of major depressive disorder: a non-randomized pilot study.

Emerging issues in the management of major depressive disorder (MDD) comprise a nonadherence to treatment and treatment failures, depressive recurrence and relapses, misidentification of incoming exacerbated phases and consequently, a chronification of depression. While antidepressant drugs constitute the standard of care for MDD, effective psychosocial interventions are needed to reduce rehospitalizations and other adverse events. The present study primarily investigated the effects and impact of implementing a structured psychoeducational intervention on the clinical course of MDD. A non-randomized comparative, pragmatic, pilot, single-center study of adults with nonpsychotic moderate or severe episode of MDD recently discharged from a psychiatric hospitalization. The consecutive subjects were allocated either to the intervention group (N=49) or to the attention control group (N=47), based on their preference. The psychoeducational intervention was based on a modified Munoz's Depression Prevention Course. Subjects were followed up prospectively for two years. The absolute changes in Beck anxiety inventory scale, Zung's depression questionnaire, and Montgomery and Äsberg depression rating scale (MADRS) total scores at 6-month follow-up were comparable between the two groups. There were lower rates of the rehospitalization within one year (2.1% vs. 16.7%; P<0.001) and less rehospitalizations after one year (6.3% vs. 25%; P<0.001), lower rates of the ongoing sickness absence (11.5% vs. 29.2%; P<0.001), less persons with disability due to MDD at 1-year follow-up (1% vs. 11.5%; P=0.002), and less nonadherent subjects who self-discontinued treatment (6.3% vs. 28.1%; P<0.001) among participants in the intervention group compared to the control group. The disability due to MDD at 1-year follow-up was predicted by the absence of the psychoeducational intervention (P=0.002) and by the MADRS total score at 6-month follow-up (OR 1.10; 95% CI 1.003-1.195; P=0.044). Qualitative data indicated the intervention was desired and appreciated by the participants, as well as being practical to implement in Slovakian clinical settings. The results suggest the psychoeducational intervention based on a modified Munoz's Depression Prevention Course has beneficial effects in adults with MDD recently discharged from a psychiatric hospitalization. The findings implicate the psychoeducational intervention may offer a new approach to the prevention of depressive relapses.

P-795 Robust and simple in vitro maturation of ovarian tissue oocytes

Abstract Study question Using in-vitro gametogenesis results in mice, can we perform simple, robust in-vitro maturation (IVM) of oocytes from human ovarian tissue? Summary answer In vitro oogenesis in mice reveals 3 phases of oocyte maturation, IVD, IVG, and IVM. In vivo IVD and IVG simplifes a more robust IVM. What is known already For fertility preservation in cancer patients, IVM of GV’s obtained from ovary tissue with live birth has been achieved, but the results are variable, and great effort has gone into trying to make the “right” culture media, and most are given booster shots of gonadotropin with questionable results. It is easy to obtain many GV oocytes from tiny follicles using open cortical dissection. But it still has remained a puzzle how to do robust IVM in the best way. Study design, size, duration A total of 146 females underwent ovary tissue cryopreservation since 1977. The most recent 38 consecutive such patients between 2 and 38 years of age underwent in-vitro maturation of oocytes (IVM) derived from their ovarian tissue. This is a prospective non-randomized pilot study based upon our results with in vitro oogenesis. Participants/materials, setting, methods After ovarian cortex dissection, the spent media is examined for cumulous complexes (CC’s), which were placed in culture with widely varying concentrations of FSH and HCG, and in a variety of different media. Based on now established mechanisms of in vitro oogenesis, we postulated that the specific media for IVM and the concentrations of HCG would not impact results. There was no prior hormone administration. Main results and the role of chance The harvested germinal vesicle oocyte developed into mature metaphase II oocytes with simple culture media just as well as with “IVM media”, and with HCG concentration from 10 mIU/l to 1000 mIU/l. Of the 38 cases, 18 had had previous chemotherapy or were pre-pubertal. None of these had CC’s. Of the 20 who were post-pubertal and had not yet undergone chemotherapy, the number of CC’s averaged 20 per patient. Of a total of 402 GV oocytes, 137 became mature MII’s (34.1%), varying between 20% and 56%. The only case with low maturation rate (9%) occurred when the cumulus was stripped immediately instead of at 24 hours. Thus mature oocytes can robustly and easily be obtained from ovary tissue with simple media and no need for ovarian stimulation. Furthermore, ovarian stimulation and ovulation are not necessary for oocyte maturation. Oocytes that have just exited IVD that have been exposed to less than 7 days of gonadotropin (IVG) will not mature. Those oocytes exposed to more than 11 days of IVG will degenerate. Thus about 35% of oocytes at any given time will have already been properly prepared in vivo for IVM. Limitations, reasons for caution This is an early proof of concept study in humans with only 30 participants. However, it is completely consistent with what we have predicted from in vitro oogenesis in the mouse. Wider implications of the findings Ovary tissue freezing along with robust IVM will at once provide cancer patients with two possibilities for fertility preservation, without having to delay cancer treatment. Four months of in vivo IVD (non-hormonal) followed by 11 days of IVG (FSH) have already prepared oocytes for IVM. Trial registration number not applicable

Using Electronic Health Record Mortality Data to Promote Goals-of-Care Discussions in Seriously Ill Transferred Patients: A Pilot Study

Abstract Background Mortality prediction data may aid in identifying seriously ill transferred patients at high risk of dying and facilitate early goals-of-care discussions (GOCD); however, this is rarely evaluated. We recently developed a model for predicting 30-day inpatient mortality, which may be useful for promoting early GOCD. Objectives Our objectives were to examine the effects of sharing model-generated mortality risk with hospitalists by assessing (1) if hospitalists agreed with the mortality risk prediction, (2) if they planned to conduct GOCD or consult palliative care within 72 hours of transfer, and (3) if the communication alert affected GOCD timing and other clinical outcomes. We also aimed to measure the association between both the model-generated and hospitalists' stratified risk assessments with patient mortality. Methods This was a nonrandomized quasi-experimental pilot study with a historical control group. On the second day of hospitalization, the model-generated risk was communicated to the hospitalists. Hospitalists were asked to answer questions via a HIPAA (Health Insurance Portability and Accountability Act)-compliant mobile communication system, and clinical outcomes were extracted via chart review. Results Eighty-four patients (42 in the control and 42 in the intervention group) were included in this study. Hospitalists agreed that all patients in the intervention group were at risk for inpatient mortality. Hospitalists were more likely to indicate a plan to conduct GOCD in the intervention group (n = 9) compared with the control group (n = 4, p &lt; 0.001). In this subset of patients, GOCD was completed within 72 hours in 78% of intervention patients (n = 7) as compared with 50% in the control group (n = 2). The greater absolute value of the model-generated mortality risk was significantly associated with deaths (p = 0.01), similar to the hospitalists' prediction of the mortality risk (p = 0.02). Conclusion Communicating model-generated mortality risk to hospitalists is a promising approach to promote timely GOCD.

Creating a digital approach for promoting physical activity in pediatric pulmonary hypertension: A framework for future interventions.

Children with pulmonary hypertension (PH) often demonstrate limited exercise capacity. Data support exercise as an effective nonpharmacologic intervention among adults with PH. However, data on exercise training in children and adolescents are limited, and characteristics of the optimal exercise program in pediatric PH have not been identified. Exercise programs may have multiple targets, including muscle deficits which are associated with exercise limitations in both adult and pediatric PH. Wearable accelerometer sensors measure physical activity volume and intensity in the naturalistic setting and can facilitate near continuous data transfer and bidirectional communication between patients and the study team when paired with informatics tools during exercise interventions. To address the knowledge gaps in exercise training in pediatric PH, we designed a prospective, single arm, nonrandomized pilot study to determine feasibility and preliminary estimates of efficacy of a 16-week home exercise intervention, targeting lower extremity muscle mass and enriched by wearable mobile health technology. The exercIse Training in pulmONary hypertEnsion (iTONE) trial includes (1) semistructured exercise prescriptions tailored to the participant's baseline level of activity and access to resources; (2) interval goal setting fostering self-efficacy; (3) real time monitoring of activity via wearable devices; (4) a digital platform enabling communication and feedback between participant and study team; (5) multiple avenues to assess participant safety. This pilot intervention will provide information on the digital infrastructure needed to conduct home-based exercise interventions in PH and will generate important preliminary data on the effect of exercise interventions in youth with chronic cardiorespiratory conditions to power larger studies in the future.

Addressing the unmet needs of women with breast cancer in Mexico: a non-randomised pilot study of the digital ePRO intervention

ObjectivesThis study aimed to explore the acceptability, feasibility, usability, and preliminary effect of an electronic patient-reported outcome (ePRO) intervention for patients with breast cancer in Mexico.DesignWe conducted a multimethod non-randomised...

Off-label use of clomiphene citrate to treat anabolic androgenic steroid induced hypogonadism upon cessation among men (CloTASH) – A pilot study protocol

BackgroundNon-prescribed anabolic androgenic steroid (AAS) use is associated with AAS-induced hypogonadism (ASIH), and metabolic, cardiovascular, and mental health risks. Symptoms of ASIH (fatigue, depression, anxiety, sexual dysfunction) are hard to endure following cessation, but there is no consensus on whether endocrine treatment should be used to treat ASIH. This proof-of-concept study aims to explore safety of off-label clomiphene citrate therapy, whether the treatment will reduce the symptoms of androgen deficiency, and to study changes in health risks after cessation. MethodsIn this open-labeled non-randomized off-label hormone intervention pilot study, we shall include males with AAS dependence intending to cease use. The 16-week intervention included clomiphene citrate, transdermal testosterone gel for the first four weeks and optional human chorionic gonadotropin (hCG) from week 4 if low treatment response. Measures of physical and mental health will be examined from ongoing AAS use, during the intervention, and at 6- and 12 months post cessation. Change in self-reported symptoms of hypogonadism and other withdrawal symptoms will be compared with data from a group of men who ended AAS use temporarily without the medical intervention. The study may provide valuable clinical insights and may be used to inform the design of future intervention studies.

Effect plyometric training increase speed and agility on tennis player: Literature Review

Purpose. The purpose of this study was to identify plyometric training for increasing speed and agility in tennis players. Material and Methods. The method used is a literature search. Data is pulled from various platforms such as Google Scholar, Scopus and Pubmed. Search Criteria 1) tennis player 2) plyometric training program 3) comparison of control group or other plyometric training group interventions with single-group trials 4) examiners must demonstrate at least one demonstrated tennis ability or physical condition. I have. 5) Non-randomized pilot studies and studies with randomized controlled designs. Search data that has been done with the keywords "plyometric" AND "training" AND "speed" OR "agility" AND "tennis". Several articles were found from Google Scholar with 487 data articles, Scopus 15 data articles and PubMed 7 data articles. The total number of articles is 507 article data, then changed again according to the discussion and topic to 12 article data. From the data of the 12 articles included in the exclusion there were four articles because these articles were not "open access". Results. The results show that there are eight studies examining plyometric training for speed and agility in tennis players. In summary, plyometric training can enhance speed and agility factors in tennis athletes. Conclusion. Therefore that plyometric training method can increase speed and agility in tennis athletes with a low risk of injury and high feasibility.

Do Hall Technique Crowns Affect Intra-arch Dimensions? A Split-mouth Quasi-experimental Non-randomized Feasibility Pilot Study.

The Hall technique preformed metal crowns (HT-PMCs) are allegedly oversized, temporarily altering inter-arch relationships. Intra-arch dimensions and leeway space (LWS) HT effects are unknown. To study single HT-PMC intra-arch effects and treated tooth dimensional changes. Split-mouth, quasi-experimental, non-randomized feasibility pilot study. Intraoral scans (iTero II®) were taken preorthodontic separator placement (scan1), immediately post single HT-PMCs (scan2) in 13 children, and 1 month later (scan3) in eight children. Control and study quadrants' lengths ("arcs") and HT-PMCs/control tooth dimensions [mesiodistal (MD), buccopalatal/lingual (BP/L), diagonal (Diag1/Diag2)] were recorded in mm (OrthoCAD® software). Paired t-test, repeated analysis of variance (ANOVA) post hoc analysis statistics (p < 0.05). Compared to scan1, the mean study arc increased by 0.7 mm (±0.5) (n = 13, t-test, p < 0.001) at scan2, while at scan3, it increased by 0.8 mm (±0.34) (n = 8, repeated ANOVA, p = 0.008). The HT-PMCs-treated tooth mean dimensions increased at scan2 by 0.9 mm (MD), 0.8 mm (BP/L), 0.5 mm (Diag1), and 0.7 mm (Diag2) (t-test, p < 0.001) with similar observations at scan3. There were no significant changes in the control arc or the control tooth measurements. One single HT-PMC increased the intra-arch quadrant length by approximately up to <1 mm. The HT-PMC-treated tooth was marginally oversized. This pilot study paves the way for a more robust study with a larger sample size. AlRamzi B, AlHalabi M, Kowash M, et al. Do Hall Technique Crowns Affect Intra-arch Dimensions? A Split-mouth Quasi-experimental Non-randomized Feasibility Pilot Study. Int J Clin Pediatr Dent 2024;17(6):673-682.

Concentrated transdiagnostic and cross-disciplinary micro-choice based group treatment for patients with depression and with anxiety leads to lasting improvements after 12 months: a pilot study

BackgroundA concentrated transdiagnostic and micro choice-based group treatment for patients with depression and anxiety has previously shown to yield significant reduction in symptoms and increased level of functioning from pre to 3-month follow-up. In the present study, we report the results after 12 months follow-up.MethodsThis was a non-randomized clinical intervention pilot study, conducted in line with a published protocol. Sixty-seven consecutively referred patients, aged 19–47 (mean age 32.5, SD = 8.0) were included and completed treatment. All had a severity of their problems that entitled them to care in the specialist public mental health care. Self-reported age at onset of symptoms was 17.6 (SD = 7.9) years. Mean number of prior treatment courses was 3.5 (SD = 3.3; range 0–20). The main objective was to assess the treatment effectiveness by questionnaires measuring relevant symptoms at pre-treatment, 7 days-, 3 months-, 6 months- and at 12-months follow-up.ResultsValidated measures of functional impairment (WSAS), depression (PHQ9), anxiety (GAD7), worry (PSWQ), fatigue (CFQ), insomnia (BIS) and illness perception (BIPQ) improved significantly (p < .0005) from before treatment to 12 months follow-up, yielding mostly large to extremely large effect sizes (0.89–3.68), whereas some moderate (0.60–0.76). After 12 months, 74% report an overall improvement in problems related to anxiety and depression. Utilization of specialist, public and private mental health care was reported as nonexistent or had decreased for 70% of the patients at 12-month follow up.ConclusionsThe concentrated, micro-choice based group treatment approach yielded a highly clinically significant reduction in a wide range of symptoms already one week after treatment, and the positive results persisted at 12-month follow-up.Trial registrationClinicalTrials.gov Identifier: NCT05234281, first posted date 10/02/2022.

Exploring the psychological and physiological outcomes of recreational pole dancing: a non-randomised pilot study

In qualitative and cross-sectional studies, participation in recreational pole dancing classes has been shown to align with improvements in body image, physical fitness, satisfaction of basic psychological needs and group identity. The purpose of this feasibility study was to quantify retention and adherence rates, along with physiological and psychological changes, across eight weeks of pole dancing classes. Of the 76 participants recruited, 68 females (age range nineteen to 60 years) attended baseline testing, a typical term of pole dancing classes at eight local studios (i.e., two 60-minute classes a week for eight weeks) and a post-program testing session resulting in an 89.5% retention rate. The adherence rate was 93.8% (mean attendance of fifteen out of sixteen classes). Significant over-time improvements with small to large effect sizes were observed in body image (body appreciation r = 0.45, figure rating r = 0.38), physical self-concept (sport r = 0.30, coordination r&amp;nbsp;= 0.41,&amp;nbsp; strength r = 0.50, endurance r = 0.28, global esteem r = 0.38, flexibility r = 0.18), physical fitness (flexed arm hang r = 0.49, step up test d = 0.26, sit and reach d= 0.23) and visceral fat mass (r = -0.16). No significant changes were observed in bone mineral density, leg lean mass or leg fat mass. Analyses also revealed important correlations between in-class experiences and psychological and physiological outcomes, which may provide insight into potential design elements within future intervention studies. The results from this study inform the design of future larger trials by (a) highlighting retention and adherence rates in an eight-week pole dancing program, (b) identifying effect sizes for key outcomes of pole dancing, and (c) providing insight into the potentially modifiable factors that might be suitable targets for intervention should researchers and practitioners seek to maximize outcomes from this form of training.Des études qualitatives et transversales ont montré que la participation à des cours de pole dance récréatif est associée à des améliorations de l'image corporelle, de la forme physique, de la satisfaction des besoins psychologiques fondamentaux et de l'identité de groupe. Cette étude de faisabilité visait à quantifier les taux d’adhésion et de rétention, ainsi que les évolutions physiologiques et psychologiques, durant huit semaines de pratique de pole dance. Sur les 76&amp;nbsp;participant·e·s recruté·e·s, 68&amp;nbsp;femmes (âgées entre 19 et 60&amp;nbsp;ans) ont participé à des tests de base, à&amp;nbsp;un cours typique de pole dance dans huit studios locaux, (soit deux ateliers d’une heure par semaine pendant huit semaines), et à une session de tests après le programme. Il en résulte un taux de rétention de 89,5&amp;nbsp;%. Le taux d’adhésion s’élève à 93,8&amp;nbsp;% (participation moyenne de 15&amp;nbsp;cours sur un total de 16 cours). Au fil du temps, des améliorations significatives avec des effets plus ou moins importants ont pu être observées sur l’image corporelle (appréciation du corps&amp;nbsp;r&amp;nbsp;=&amp;nbsp;0,45, évaluation des formes&amp;nbsp;r&amp;nbsp;=&amp;nbsp;0,38), l’image de soi physique (sport&amp;nbsp;r&amp;nbsp;=&amp;nbsp;0,30, coordination&amp;nbsp;r&amp;nbsp;=&amp;nbsp;0,41, force&amp;nbsp;r&amp;nbsp;=&amp;nbsp;0,50, endurance&amp;nbsp;r&amp;nbsp;=&amp;nbsp;0,28, estime globale&amp;nbsp;r&amp;nbsp;=&amp;nbsp;0,38, souplesse&amp;nbsp;r&amp;nbsp;=&amp;nbsp;0,18), la forme physique (traction&amp;nbsp;r&amp;nbsp;=&amp;nbsp;0,49, Queens College Step Test d&amp;nbsp;=&amp;nbsp;0,26, souplesse en position assise&amp;nbsp;d&amp;nbsp;=&amp;nbsp;0,23) et la masse de graisse viscérale (r&amp;nbsp;=&amp;nbsp;-0,16). L’étude ne montre aucun changement significatif sur la densité minérale osseuse, sur la masse maigre au niveau des jambes ou sur la masse grasse. Les analyses ont également révélé d’importantes corrélations entre des expériences vécues en cours et des résultats psychologiques et physiologiques. Ces découvertes pourraient être très utiles pour d’éventuels éléments de conception dans le cadre de futures études d’intervention. Les conclusions de cette étude orientent la conception de futurs essais à plus grande échelle en (a) mettant en évidence les taux d’adhésion et de rétention durant un programme de pole dance sur huit semaines, (b) identifiant les tailles d’effets&amp;nbsp;pour les principaux résultats du pole dance, et (c) donnant des informations utiles sur les facteurs potentiellement modifiables qui pourraient s’appliquer au domaine expérimental si des chercheur·euse·s et praticien.nes souhaitent optimiser les résultats pour cette pratique.

Improving diagnostics using extended point-of-care testing during in-home assessments of older adults with signs of emerging acute disease: a prospective observational non-randomised pilot and feasibility study

BackgroundDelayed recognition of acute disease among older adults hinders timely management and increases the risk of hospital admission. Point-of-Care testing, including Focused Lung Ultrasound (FLUS) and in-home analysis of biological material, may support clinical decision-making in suspected acute respiratory disease. The aim of this study was to pilot test the study design for a planned randomised trial, investigate whether in-home extended use of point-of-care testing is feasible, and explore its’ potential clinical impact.MethodsA non-randomised pilot and feasibility study was conducted during September–November 2021 in Kolding Municipality, Denmark. A FLUS-trained physician accompanied an acute community nurse on home-visits to citizens aged 65 + y with signs of acute respiratory disease. The acute community nurses did a clinical assessment (vital signs, capillary C-reactive protein and haemoglobin) and gave a presumptive diagnosis. Subsequently, the physician performed FLUS, venipuncture with bedside analysis (electrolytes, creatinine, white blood cell differential count), nasopharyngeal swab (PCR for upper respiratory pathogens), and urine samples (flow-cytometry). Primary outcomes were feasibility of study design and extended point-of-care testing; secondary outcome was the potential clinical impact of extended point-of-care testing.ResultsOne hundred consecutive individuals were included. Average age was 81.6 (SD ± 8.4). Feasibility of study design was acceptable, FLUS 100%, blood-analyses 81%, PCR for upper respiratory pathogens 79%, and urine flow-cytometry 4%. In addition to the acute community nurse’s presumptive diagnosis, extended point-of-care testing identified 34 individuals with a condition in need of further evaluation by a physician.ConclusionOverall, in-home assessments with extended point-of-care testing are feasible and may aid to identify and handle acute diseases in older adults.