Prospective Single-arm Study Research Articles

Assessing the efficacy and safety of a novel, registration-free, CT-guided percutaneous transthoracic needle biopsy navigation system (RC120): A multicenter, prospective, single-arm clinical trial.

197 Background: Current optical and electromagnetic navigation systems for CT-guided percutaneous transthoracic needle biopsies (PTNB) have limitations. They require surface markers on the patient and intraoperative registration. Specific patient positioning during biopsies is required. Our team developed a new navigation system that addresses these issues. It doesn’t rely on patient surface markers or intraoperative registration, and it provides more flexibility in patient positioning during biopsies. Our research evaluates the effectiveness and safety of this system. Methods: A single-arm prospective study was conducted, including participants aged 18-80 years prepared for percutaneous lung core biopsy at two clinical centers in China. The primary endpoint was the success rate of biopsies within 2 needle adjustments. The secondary endpoint was the success rate of biopsies within a single needle adjustment. Safety endpoints were defined by the occurrence of adverse events. The number of CT scans patients underwent during the procedure was used to assess radiation dosage. Follow-up was conducted on subsequent pathological and molecular diagnoses. Results: The study included 98 patients from two sites, with a median age of 64 years. Most participants were males, accounting for 72.45% (71 out of 98). The primary endpoint was achieved with a biopsy success rate of 98.98%, requiring a maximum of two needle adjustments. The secondary endpoint was met, demonstrating a biopsy success rate of 97.96% with a maximum of one needle adjustment. The overall success rate was 98.98%, with a 95% confidence interval (CI) of 94.45% to 99.97%, significantly exceeding the target value of 85% (P < 0.0001). The median number of CT scans was 3, ranging from 3 to 12. The average duration of the procedure was 18.0 minutes. Regarding safety endpoints, the two most common adverse events were hemorrhage in the lesion (14 instances, 29.17%) and pneumothorax (8 instances, 16.67%). Other adverse events included elevated blood pressure (5 instances, 10.42%), hemoptysis (4 instances, 8.33%), and other common adverse events such as cough, constipation, anemia, and bloody sputum, each occurring twice. There were 9 other less common adverse events, each occurring once. These adverse events are common in PTNB and can be attributed to the puncture operation itself, not our navigation system. Conclusions: Our new registration-free navigation system proved to be an effective, efficient, safe, and well-utilized system for assisting percutaneous lung biopsies in clinical practice. Clinical trial information: ChiCTR2300072197 .

Goldilocks mastectomy; a modified technique enhancing the aesthetic outcome presented as a single center single-arm prospective cohort study

BackgroundGoldilocks mastectomy represents a midway solution for breast reconstruction between flat chest and sophisticated reconstructive techniques. The literature lacks a standardization of the technique. In this study, we present a step-by-step approach with modifications in the original technique achieving better breast shape and contour within the context of standardization of the technique. MethodsA single arm prospective study was conducted at our center in which female patients with large ptotic breasts indicated for mastectomy were included. Patients with locally advanced skin changes, inflammatory carcinoma, stage IV disease as well as male patients were excluded. Recruited patients were subjected to the same surgical steps. Contralateral breast symmetrization was performed by reduction technique to patients who accepted this. All patients were requested to report their degree of satisfaction according to a simple 5-point Likert scale. Follow up mammogram was performed to all patients 1 year after the procedure. ResultsA total of 55 patients were included with a median (IQR) age of 56.0 (50.0–62.0) years. The median (IQR) BMI was 41.20 (36.55–44.35)Kg/m2. The median (IQR)operative time was 115.0 (105.0–120.0) minutes. Complications were encountered in 12 patients (21.8 %). The follow up period ranged from 19 to 66 months with a median (IQR) 36.0 (28.0–45.0)months. 98.2 % of the studied patients were either satisfied or extremely satisfied. ConclusionsGoldilocks mastectomy is a valid mastectomy option for selected patients with large ptotic breasts. Standardization of the surgical steps can help in improving the aesthetic outcome.

Intraoperative pelvic neuromonitoring based on bioimpedance signals: a new method analyzed on 30 patients

PurposeIncreasing importance has been attributed in recent years to the preservation of the pelvic autonomic nerves during rectal resection to achieve better functional results. In addition to improved surgical techniques, intraoperative neuromonitoring may be useful.MethodsThis single-arm prospective study included 30 patients who underwent rectal resection performed with intraoperative neuromonitoring by recording the change in the tissue impedance of the urinary bladder and rectum after stimulation of the pelvic autonomic nerves. The International Prostate Symptom Score, the post-void residual urine volume and the Low Anterior Resection Syndrome Score (LARS score) were assessed during the 12-month follow-up period.ResultsA stimulation-induced change in tissue impedance was observed in 28/30 patients (93.3%). In the presence of risk factors such as low anastomosis, neoadjuvant radiotherapy and a deviation stoma, an average increase of the LARS score by 9 points was observed 12 months after surgery (p = 0,04). The function of the urinary bladder remained unaffected in the first week (p = 0,7) as well as 12 months after the procedure (p = 0,93).ConclusionThe clinical feasibility of the new method for pelvic intraoperative neuromonitoring could be verified. The benefits of intraoperative pelvic neuromonitoring were particularly evident in difficult intraoperative situations with challenging visualization of the pelvic nerves.

A prospective non-randomized feasibility study of an online membership-based fitness program for promoting physical activity in people with mobility impairments

BackgroundPeople with mobility limitations have a disproportionately higher rate of acquiring secondary conditions such as obesity, cardiovascular comorbidity, pain, fatigue, depression, deconditioning, and type 2 diabetes. These conditions often result from poor access to home and community-based health promotion/wellness programs. The aim of this project was to determine the feasibility of delivering an online community membership-based fitness program for individuals with mobility impairments.MethodsFor this prospective single-arm study, participants were recruited from members of a community fitness facility that serves people with physical disabilities and chronic health conditions. While all members had access to the online platform, individuals had to opt-in to participate in the research component. Activity options included 16 pre-recorded videos and 9 live exercise classes. During the 8-week program, participants had an opportunity to earn three exercise incentives for reaching certain activity milestones. Enrollment percentage, attendance, and attrition were tracked to assess program feasibility and acceptability. Changes in participant-reported outcomes including self-reported physical activity, psychosocial outcomes, and health-related quality of life (HRQOL) were examined using non-parametric analyses.ResultsA total of 146 eligible individuals were screened of which 33 enrolled (22.6%). Two participants withdrew from the study, so a total of 31 were used for analyses. Participants included 29 women and 12 Black people with an average age of 60 (± 15.9) years. Health conditions included stroke, post-polio, arthritis, neuropathy, cerebral palsy, and obesity. Ten participants used an assistive device to get around inside the home. Twenty-six participants (78.8%) completed the online program, and 5 participants earned all 3 participation incentives. The mean number of live Zoom exercise classes attended by the participants was 12.8 (range = 0–43) over 8 weeks; 3 of 31 participants did not attend any classes. On average, participants watched 128 min (range = 0–704 min) of pre-recorded videos; 6 of 31 participants did not view any pre-recorded videos. Self-reported physical activity showed the largest improvement (11.15 units; 95% CI, 3.08, 19.56) with an effect size of 0.51 (Cohen’s d).ConclusionsThis pilot study of an online membership-based fitness program for people with mobility impairments demonstrated preliminary effectiveness in increasing physical activity and was found to be feasible and acceptable. Feasibility endpoints do indicate potential to improve retention. These results suggest that online delivery of exercise programs can broaden the reach of specialized community fitness programs and is a promising direction for future work and fully powered trials are warranted to assess intervention efficacy.Trial registrationClinicalTrials.gov, NCT05138809. Registered September 2, 2021, ClinicalTrials.gov PRS: Record Summary NCT05138809.

A novel hybrid prosthesis for open repair of acute DeBakey type I dissection with malperfusion: Early results from the PERSEVERE trial

BackgroundOutcomes after hemiarch repair for acute DeBakey type I aortic dissection (ADTI) remain unfavorable, with high rates of major adverse events and negative aortic remodeling. The PERSEVERE study evaluates the safety and effectiveness of the AMDS Hybrid prosthesis, a novel bare metal stent, in patients presenting with preoperative malperfusion. MethodsPERSEVERE is a prospective single-arm investigational study conducted at 26 sites in the United States. Ninety-three patients underwent ADTI aortic dissection repair with AMDS implantation. The 30-day primary endpoints are a composite rate of 4 major adverse events and the rate of distal anastomotic new entry tears. The secondary endpoints include aortic remodeling. ResultsClinical malperfusion was documented in 76 patients (82%); only radiographic malperfusion, in 17 (18%). The median follow-up in the 93 patients was 5.6 months. Within 30 days, 9 patients died (9.7%), 10 patients (10.8%) experienced new disabling stroke, and 18 patients (19.4%) had new-onset renal failure requiring ≥1 dialysis treatment. There were no cases of myocardial infarction. The composite rate of major adverse events (27%) was lower than that reported in the reference cohort (58%). There were no distal anastomotic new entry tears. Technical success was achieved in 99% of patients. Early remodeling indicated total aortic diameter stability, true lumen expansion, and false lumen reduction in the treated aortic segment. ConclusionsEarly results show significant reductions in major adverse events and distal anastomotic new entry tears, successfully meeting both primary endpoints. The technical success rate was high. AMDS can be used safely in patients with ADTI dissection with malperfusion.

Concussion Reduction in Division I and II Athletes: Effects of Simple Cervical Spine Exercise Regimen.

Primary preventative medicine lacks a consensus on effective concussion prevention strategies for collegiate athletes. Cervical strength has been identified as a potential factor in concussion risk reduction. This study evaluates the impact of a commercially available, portable cervical muscle stretching and strengthening device, NeckX®, on cervical strength, range of motion (ROM), and concussion incidence in collegiate athletes participating in high-concussion-risk sports. A single-arm prospective cohort study was conducted with 162 collegiate athletes from various sports. Participants underwent a 12-week neck exercise protocol using the NeckX® device. Clinical data, including neck strength and ROM, were collected at weeks 0, 6, and 12. Concussion incidence was self-reported by participants and cross-referenced with records from the athletic department. Data were analyzed for significant neck strength and ROM changes throughout the 12-week study. A two-way analysis of variance multiple comparisons with the Tukey-Kramer significant difference test was utilized, using the Holm-Sidak method, with an alpha of 0.05. All athletic teams experienced a significant increase in cervical strength during the 12-week intervention (α = 0.05, p < 0.05). Increases in cervical flexion and extension force were most consistent between teams. Cervical ROM increased significantly in male and female soccer players (α = 0.05, p < 0.05). The overall incidence of head and neck injuries, including concussions, was reduced to 6.60% during the study period, the lowest recorded value in the university's athletic department history. The use of the NeckX® device for 12 weeks was effective in enhancing pericervical muscle strength and ROM while reducing concussion incidence in collegiate athletes participating in high-concussion-risk sports. Interestingly, the positive outcomes were consistent for both males and females, indicating the universal advantages of neck training among collegiate athletes. These findings support existing research on the benefits of cervical strengthening exercises for reducing concussions in collegiate athletes and highlight the convenience and affordability of using this device.

Impact of a Health Coach-Led, Text-Based Digital Behavior Change Intervention on Weight Loss and Psychological Well-Being in Patients Receiving a Procedureless Intragastric Balloon Program: Prospective Single-Arm Study.

Digital health interventions show promise for weight management. However, few text-based behavior change interventions have been designed to support patients receiving intragastric balloons, and none have simultaneously evaluated weight loss, psychological well-being, and behavior change despite the crucial interplay of these factors in weight management. This study aims to assess whether a health coach-led, asynchronous, text-based digital behavior change coaching intervention (DBCCI) delivered to participants receiving an intragastric balloon and its aftercare program was feasible and acceptable to participants and supported improved outcomes, including weight loss, psychological well-being, and lifestyle behavior change conducive to weight loss maintenance. This 12-month, single-arm prospective study enrolled adults aged 21 to 65 years with BMI ≥27kg/m2 receiving a procedureless intragastric balloon (PIGB) at 5 bariatric clinics in the United Kingdom and the Netherlands. Participants received the DBCCI and the clinic-led PIGB aftercare program (remotely delivered) for 6 months after PIGB placement and then no intervention for an additional 6 months. The DBCCI was an evidence-based, personalized intervention wherein health coaches supported participants via exchanged asynchronous in-app text-based messages. Over the 12-month study, we assessed percentage of total body weight loss and psychological well-being via self-administered validated questionnaires (Warwick-Edinburgh Mental Wellbeing Scale, Generalized Anxiety Disorder Scale, Impact of Weight on Quality of Life-Lite-Clinical Trials Version, Loss of Control Over Eating Scale-Brief, Weight Efficacy Lifestyle Questionnaire-Short Form, and Barriers to Being Active Quiz). Participant engagement with and acceptability of the intervention were assessed via self-reported surveys. Overall, 107 participants (n=96, 89.7% female; mean baseline BMI 35.4, SD 5.4kg/m2) were included in the analysis. Mean total body weight loss was 13.5% (SEM 2.3%) at the end of the DBCCI and 11.22% (SEM 2.3%) at the 12-month follow-up (P<.001). Improvements were observed for all psychological well-being measures throughout the 12 months except for the Generalized Anxiety Disorder Scale (improvement at month1) and Barriers to Being Active Quiz (improvements at months3 and 6). Surveys showed high levels of engagement with and acceptability of the DBCCI. This study provides evidence that the health coach-led, asynchronous, text-based DBCCI was engaging and acceptable to participants with overweight and obesity. The DBCCI, delivered alongside the PIGB and its aftercare program, supported improved weight loss outcomes and psychological well-being versus baseline and was associated with lifestyle behavior changes known to help achieve and maintain long-term weight loss and improved health outcomes. Follow-up findings suggest a potential need for longer-term, more intense coaching to focus on weight loss maintenance and support ongoing self-coaching. This could be achieved by leveraging generative artificial intelligence to provide ongoing automated behavior change coaching support to augment human-led care. ClinicalTrials.gov NCT05884606; https://clinicaltrials.gov/study/NCT05884606.

Mid-term outcomes of a smoking cessation program in hospitalized patients in Türkiye.

'Teachable moments', such as inpatient treatment periods, can be turned into opportunities for smokers to acquire healthy living behaviors. This study was conducted to evaluate the outcomes of smoking cessation interventions in an inpatient hospital setting. Data were collected for this single-arm prospective intervention cohort study between October 2021 and March 2022 from hospitalized patients at Recep Tayyip Erdoğan University Training and Research Hospital in Türkiye. Smoker patients received smoking cessation counseling and brief smoking cessation interventions during their hospitalization and were informed about how to apply to our hospital's smoking cessation outpatient clinic after discharge. They were followed via phone on the 3rd, 5th, and 7th day and the 1st, 3rd, 6th, and 12th month after their discharge, regarding their quit status as well as admissions to smoking cessation clinics. Quitters were confirmed by exhaled air carbon monoxide testing. Logistic regression analysis was performed to evaluate the presence of admission to the emergency department and family physicians at follow-up at 1st year. The model was adjusted in terms of age, sex, presence of malignancy, and education level. Of the 183 patients included in the study, 163 participants completed periodic follow-up during one year, with quit rate of 47.2%. The rate of anxiety was higher among non-quitters compared to quitters (9.4% vs 1.2%) (p=0.024). Non-quitters were 19 times more likely to have emergency department admissions (AOR=19.64; 95% CI: 8.08-47.68) and eight times more likely to have family doctor visits (AOR=8.43; 95% CI: 4.05-17.53) than quitters. This cessation program evaluated the quit rates of hospitalized patients in the first year and revealed that the rate of anxiety was higher in non-quitters compared to quitters. It would be an important approach to include psychiatric support in this practice.

Symptom-triggered testing detects early stage and low volume resectable advanced stage ovarian cancer

ObjectiveSymptom-triggered testing for ovarian cancer was introduced to the UK whereby symptomatic women undergo an ultrasound scan and serum CA125, and are referred to hospital within 2 weeks if these...

Promoting serious illness conversations in primary care through telehealth among persons living with cognitive impairment.

serious illness conversations (SIC), particularly for persons living with cognitive impairment (PLCI), inconsistently happen in primary care. Pragmatic, scalable strategies are needed to promote SIC for PLCI. Pragmatic, prospective single-arm pilot study that occurred between July 1, 2021 and May 30, 2022 across seven primary care practices in North Carolina. Community-dwelling patients aged 65 and older with known or probable mild cognitive impairment or dementia (with decision-making capacity) and their care partners (if available). SIC telehealth intervention (TeleVoice) via video or telephone to assist PLCI in discussing their current goals, values, and future medical preferences, while facilitating documentation within the EHR. Main feasibility outcomes included reach/enrollment, intervention completion, and adoption rates at the clinic and provider level. Primary effectiveness outcomes included SIC documentation and quality within the EHR and usage of advance care planning billing (ACP) codes. Of the 163 eligible PLCI approached, 107 (66%) enrolled (mean age 83.7 years, 68.2% female, 16.8% Black, 22% living in a geographic area of high socioeconomic disadvantage) and 81 (76%) completed the SIC telehealth intervention; 45 care partners agreed to participate (mean age 71.5 years, 80% female). Adoption at clinic level was 50%, while 75% of providers within these clinics participated. Among PLCI that completed the intervention, SIC documentation and usage of ACP billing codes was 100% and 96%, respectively, with 96% (n = 78) having high-quality SIC documentation. No significant differences were observed between telephone and video visits. These findings provide preliminary evidence to support the feasibility of conducting SICs through telehealth to specifically meet the needs of community-dwelling PLCI. Further investigation of the sustainability of the intervention and its long-term impact on patient and caregiver outcomes is needed.

Endoscopic Membranectomy's Role in the Treatment of Nonhomogeneous Chronic Subdural Hematoma (EMiT-CSDH): Prospective Single-arm Interventional Pilot Study

Chronic subdural hematoma (CSDH) is a prevalent neurosurgical condition characterized by blood accumulation within the border cell layer. Despite various treatment options-medical, endovascular, and surgical-recurrence rates remain high. Our pilot study investigates the safety and efficacy of endoscopic membranectomy (EM) in reducing recurrence in nonhomogenous CSDH. This was a prospective single-arm interventional pilot study from March to June 2023. It included patients of all ages who presented with symptomatic nonhomogenous CSDH requiring surgical intervention. A total of 19 patients were enrolled in this study. The average age was 60.4 ± 10.4 years. The male:female ratio was 5.3:1. In this group, 73.7% (n= 14) of patients had a history of trauma. All patients presented with a history of altered sensorium and contralateral limb weakness. The most common type of CSDH was trabecular (42.1%), followed by gradient (21%), separated (15.8%), and laminar (15.8%). The average duration of surgery was 43.42 ± 10 minutes. CSDH may be thin or thick based on its tractability and has significance in EM technique. All patients started recovering within 24 hours. All patients were asymptomatic, without any neurologic deficit, at 2 weeks, and remained so at the 6-month review. In 17 patients, the 6-month follow-up computed tomography did not show any bleeding/recurrence. There were no postoperative seizures, wound-healing issues, or infections. There are multiple treatment options for CSDH at present. EM is a potentially safe and effective treatment for CSDH, with lower recurrence and faster recovery. Large-scale controlled studies on EM are required.

Safety and efficacy of very low calorie diet in patients receiving haemodialysis therapy.

Very low calorie diets (VLCDs) are an obesity treatment option in the general population, but their efficacy and safety in patients on haemodialysis (HD) is unknown. Prospective single arm study of VLCD in haemodialysis patients. All participants received 2.5-3.3MJ/day for 12weeks. Weekly assessment of VLCD, pre- and post-dialysis weight, inter-dialytic weight gain, and blood electrolytes occurred for the first 4 weeks, then fortnightly for another 8 weeks. Linear mixed models compared the change in weight over time as well as biochemical outcomes including potassium. Twenty-two participants [nine home HD (HHD) and 13 satellite HD (SHD)] enrolled with 19 completing the 12-week intervention. Mean post-dialysis weight declined from 121.1kg at baseline to 109.9 at week 12 resulting in average decline of 0.88kg per week (95% C.I. 0.71, 1.05, P<.001) with 12-week mean percentage weight loss9.3% (SD 3.5). Mean post-dialysis body mass index declined from 40.9kg/m2 at baseline to 37.1kg/m2 at week 12 (95% C.I. 0.25, 0.35, P<.001). Serum potassium rose from week 1 to 3, stabilized during weeks 4 to 6, and fell from week 8, returning near baseline by week 12. Six of the nine (66.6%) HHD participants and seven of the 13 (70%) SHD participants had at least one episode of hyperkalaemia (K>6mmol/l). There were no clinical changes in serum sodium, corrected calcium, or phosphate levels during the study. VLCD with dietitian supervision was effective in producing significant weight reduction, with an acceptable safety profile in patients treated with haemodialysis.

Memantine to Reduce Cognitive Impairment After Radiation in Children: A Pilot Study Evaluating the Feasibility of Memantine in Reducing Cognitive Impairment in Pediatric Patients after Radiation Therapy for Central Nervous System Tumors

Memantine is standard in certain adults receiving brain radiation therapy (RT) to decrease cognitive impacts, but it is unknown whether pediatric patients can take, tolerate, and/or benefit from memantine. In this prospective single-arm feasibility study, we hypothesized that pediatric patients receiving central nervous system (CNS) RT would tolerate memantine with good adherence. Patients aged 4 to 18 years with a primary CNS malignancy (excluding World Health Organization grade 4 astrocytoma, glioblastoma) receiving intracranial RT were eligible. A 6-month memantine course was given during and after RT, with dose titration in 5 mg increments over 4 weeks targeting a weight-based maximum (0.4 mg/kg to the closest 5 mg), not to exceed 10 mg twice a day. The primary endpoint was to achieve 80% drug adherence rate in 80% of patients measured 1 month after RT. Secondary objectives included memantine feasibility at 3 and 6 months. Eighteen patients enrolled from 2020 to 2022 and were prescribed memantine with RT. The study closed early to avoid competing with the phase 3 randomized Children's Oncology Group study ACCL2031. No predefined stopping rules were met. One patient withdrew for cognition-altering substance use, leaving 17 patients available for analysis. One patient discontinued memantine after one dose due to nausea. For the remaining 16 patients, there was a median of 100% pill completion rate (range, 74%-100%; n = 9/17 with 100% adherence) at 1 month after RT, with 15/16 (94%) with adherence rates >80%. At the 3- and 6-month post-RT time points for secondary endpoints, the median adherence rates were 100% (range, 55%-100%) and 96% (range, 33%-100%), respectively. Grade 1 to 2 fatigue, headache, and nausea were the most common toxicity events, at least possibly related to the study drug (n = 27), without attributable grade 3+ events. Memantine is a feasible, safe, and well-tolerated addition to multimodality treatment for pediatric CNS malignancies. Results of ACCL2031 are awaited to define the value of memantine in this population.

Combining app-based behavioral therapy with electronic cigarettes for smoking cessation: a study protocol for a single-arm mixed-methods pilot trial

BackgroundCigarette smoking remains a leading cause of preventable illness and death, underscoring the need for effective evidence-based smoking cessation interventions. Nuumi, a novel smoking cessation program integrating a digital behavioral therapy and an electronic cigarette, may provide a solution.ObjectiveTo investigate the initial efficacy, acceptability and psychological outcomes of an evidence-based smoking cessation intervention comprised of a mobile phone app and an electronic cigarette among adults who smoke and who are motivated to quit.MethodsA prospective 6-month single-arm mixed-methods pilot study will be conducted. Seventy adults who smoke and who are motivated to quit will be recruited via web-based advertisements and flyers. Participants receive access to an app and an electronic cigarette with pods containing nicotine for temporary use of at least 3 months. The electronic cigarette is coupled with the app via Bluetooth, allowing for tracking of patterns of use. The behavioral therapy leverages evidence-based content informed by cognitive behavioral therapy and mindfulness-informed principles. Web-based self-report surveys will be conducted at baseline, at 4 weeks, at 8 weeks, at 12 weeks, and at 24 weeks post-baseline. Semi-structured interviews will be conducted at baseline and at 12 weeks post-baseline. Primary outcomes will be self-reported 7-day point prevalence abstinence from smoking at 12 weeks and 24 weeks. Secondary outcomes will include other smoking cessation-related outcomes, psychological outcomes, and acceptability of the nuumi intervention. Descriptive analyses and within-group comparisons will be performed on the quantitative data, and content analyses will be performed on the qualitative data. Recruitment for this study started in October 2023.DiscussionAs tobacco smoking is a leading cause of preventable morbidity and mortality, this research addresses one of the largest health burdens of our time. The results will provide insights into the initial efficacy, acceptability, and psychological outcomes of a novel mobile health intervention for smoking cessation. If successful, this pilot may generate an effective intervention supporting adults who smoke to quit smoking. The results will inform feasibility of a future randomized controlled trial.Trial Registration German Clinical Trials Register DRKS00032652, registered 09/15/2023, https://drks.de/search/de/trial/DRKS00032652.

Insights into Digital MedicRehApp Maintenance Model for Pulmonary Telerehabilitation: Observational Study.

Maintenance strategies after center-based pulmonary rehabilitation (CBPR) are currently needed. This study aimed to evaluate the feasibility and effect on the quality of life of a home-based pulmonary rehabilitation (HBPR) program delivered by a digital app. As secondary objectives, the patients' adherence, symptoms, effort tolerance changes, and safety were evaluated. This was a single-arm prospective observational monocentric study on 30 patients referred for chronic respiratory diseases. The prescription and evaluations of the HBPR programs performed at the pulmonary facility and delivery of structured exercise and counselling by the digital health tool were achieved under the supervision of a respiratory therapist. Digital capabilities included aerobic, strength, and respiratory exercises, which were monitored with a fitness tracker. The engagement rate of the HBPR after the CBPR was 1:10. The EuroQoL VAS score increased from 66.2 ± 16.28 to 75.60 ± 16.07 (p < 0.001), mainly in younger subjects. No patient was lost during the HBPR program. The global adherence session rate was 94%. The Medical Research Council dyspnea scale (MRC), COPD Assessment Test (CAT) score, and six-minute walking test (6MWT) improved from admission into the pulmonary unit to the end of the HBPR program. Between the beginning and end of the CBPR, the CAT score decreased from 14.4 ± 6.39 to 8.50 ± 5.39 (p < 0.001), the MRC decreased from 1.87 ± 0.9 to 1.17 ± 0.83 (p < 0.001), and the 6MWT increased from 451 ± 93 to 473 ± 115 m (p < 0.05). The average Technology Acceptance Model score for usability was high (145 ± 12.1) and no adverse events occurred during the HBPR program. This HBPR model seemed to be feasible and well-accepted by patients, leading to improvements in quality of life, symptoms, and functional capacity.

Cumulative sucrose exposure for repeated procedural pain in preterm neonates and neurodevelopment at 18 months of corrected age: a prospective observational longitudinal study

IntroductionOral sucrose is repeatedly administered to neonates in the neonatal intensive care unit (NICU) to treat pain from commonly performed procedures; however, there is limited evidence on its long-term cumulative...

Effect of Kaishora Guggulu and Madhusnuhi Rasayana in the management of gout (Vatarakta): An open-label single-arm prospective study

Abstract BACKGROUND: Vatarakta, also known as Adhayavata, is attributed to diverse etiological factors, such as imbalanced dietary practices, occupational factors, sedentary lifestyles, and environmental influences. The symptomatology of Vatarakta resembles that of gout in contemporary medicine. While nonsteroidal anti-inflammatory drugs), colchicine, and corticosteroids are used in acute management in conventional treatment, there is a growing recognition of the need for safer and more effective alternatives. Ayurvedic formulations, such as Kaishora Guggulu (KG) and Madhusnuhi Rasayana (MR) are used commonly in clinical practice for similar conditions, and they can be potentially validated for their therapeutic potential in gout. OBJECTIVES: The study was designed to evaluate the therapeutic effect and safety of Ayurvedic formulations: KG and MR in the management of Vatarakta (gout). MATERIALS AND METHODS: The study was conducted as an open-label single-arm prospective trial at the Central Research Institute for Hepatobiliary Disorders, Bhubaneswar, Odisha, India. A total of 68 patients meeting the diagnostic criteria for primary gouty arthritis set by the American College of Rheumatology were screened according to the selection criteria, with 55 ultimately participating in the study. The treatment protocol consisted of administering KG (1000 mg) and MR (10 g) twice daily after meals with lukewarm water for 12 weeks, followed by a 2-week follow-up period, without intervention. Clinical outcomes included evaluating changes in various parameters, including clinical assessment, 36-item Short Form Health Survey (SF-36) health survey score, patient’s global assessment score, physician global assessment score (Visual Analog Scale) score for pain, and serum uric acid levels from baseline to the 84th-day visit of the study. RESULTS: After 84 days of the study, statistically significant changes were found in clinical symptoms, joint pain, and SF-36 health survey parameters, including physical functioning, emotional well-being, social functioning, and general health (P &lt; 0.0001). The mean serum uric acid at the baseline was 7.39 ± 0.55, which reduced to 5.35 ± 1.48 after treatment, which was significant (P &lt; 0.0001). During the trial period, no adverse events were reported. CONCLUSION: Despite variations in demographics, such as gender, socioeconomic status, age groups, Prakriti, and geographic region, Ayurveda treatment exhibited a significant response, accompanied by a notable reduction in serum uric acid levels. The absence of adverse reactions throughout the trial period further supports the safety profile of these formulations. These positive outcomes advocate for the use of KG and MR in gout treatment regimens, offering patients a well-tolerated and beneficial therapeutic option.

Evaluation of a mobile behavior change program for weight loss in breast cancer survivors

Post-diagnosis weight gain is common in early-stage breast cancer and is associated with increased risk of recurrence and mortality. Intentional weight loss is difficult to maintain, and digital lifestyle interventions may provide a scalable approach to address this challenge. In this prospective single-arm study (ClinicalTrials.gov NCT04753268; February 15, 2021), key eligibility criteria included: stage I–III breast cancer, body mass index (BMI) ≥ 27.5 kg/m2, and completion of cancer treatment ≥6 months before study enrollment. Participants were provided with a behavioral change mobile application (Noom®). The primary endpoint was a change in self-reported weight from baseline to 26 weeks. Secondary endpoints included engagement, changes in physical activity, dietary patterns, and patient-reported outcomes (PRO). In total, 31 patients were enrolled (mean age 56.8 ± 9.9, mean baseline BMI 33.5 kg/m2 ± 6.5). The mean weight change was −4.8 kg ( ± 4.4, P < 0.001), mean percent weight change was −5.6% ( ± 5.0%); 11/31 patients (35.5%) lost ≥5% of their initial weight. Metrics of digital application engagement associated with weight loss ≥5% included articles read (P = 0.012), weights logged (P = 0.006), food records logged (P = 0.001), messages sent (P = 0.001), and application open count (P = 0.014). Significant increases were seen in mean daily step count (P = 0.004), GPAQ scores (P = 0.002), and Body Image Scale scores (P < 0.001). Mean energy intake remained consistently in a calorie-restricted range of 1300–1400 kcal/day. In this study, breast cancer survivors were highly engaged with a behavioral change smartphone application which led to clinically significant weight loss, increased physical activity, maintenance of an energy-restricted diet, and improvements in body image.

The Success of Mifepristone and Misoprostol in the Management of Early Pregnancy Loss at a Community Hospital: A Prospective Study

ObjectivesThis prospective single-arm study was conducted to understand the expulsion rate of the gestational sac in the management of early pregnancy loss (EPL). MethodsWe recruited 441 participants; 188 met the eligibility criteria. Participants were 18 years of age and older who experienced a confirmed EPL (<12 weeks gestational age) defined by an intrauterine pregnancy with a non-viable embryonic or anembryonic gestational sac with no fetal heart activity. Participants were given 200 mg of mifepristone pre-treatment orally followed by 2 doses of misoprostol 800 μg vaginally after 24 and 48 hours. Participants were seen in follow-up on day 14 to confirm the absence of a gestational sac, classified as treatment success. For failed treatment (defined by retained gestational sac), we offered expectant management or a third dose of misoprostol and/or dilatation and curettage. We followed all participants for 30 days. We collected data on overtreatment for retained products of conception and hospital admissions for adverse events. ResultsOverall, 181 participants followed the protocol and 169 (93.3%) participants had a complete expulsion of the gestational sac by the second visit (day 14). Twelve (6.6%) failed the treatment and 1 had an adverse event of heavy vaginal bleeding requiring dilatation and curettage. Despite the expulsion of the gestational sac, 29 cases (17.1%) at subsequent follow-up were diagnosed as retained products of conception based on ultrasound assessment of thickened endometrium. ConclusionsPretreatment with mifepristone followed by 2 doses of misoprostol with a 14-day follow-up resulted in a high expulsion rate and is a safe management option for EPL.

Baseline monocyte count predicts symptom improvement during intravenous ketamine therapy in treatment-resistant depression: a single-arm open-label observational study.

Neuroinflammatory processes in depression are associated with treatment resistance to conventional antidepressants. Ketamine is an effective new therapeutic option for treatment-resistant depression (TRD). Its well-established immunomodulatory properties are hypothesized to mediate its antidepressant effect. In this context, higher levels of inflammation may predict a better treatment response. However, conclusive evidence for this hypothesis is lacking. We thus investigated whether standard peripheral inflammatory cell markers and C-reactive protein (CRP) levels could predict symptom improvement during intravenous ketamine therapy in TRD patients. 27 participants with TRD were treated with six weight-adjusted intravenous ketamine infusions (0.5 mg/kg bodyweight) over three weeks. Baseline assessments included CRP, absolute monocyte count (AMC), and absolute neutrophil count (ANC). Depression severity was measured using the Montgomery-Åsberg Depression Rating Scale (MADRS) at baseline (D1), after the first (D3) and before the last ketamine infusion (D18). Raters were blinded for the baseline laboratory assessments. 13 participants responded to ketamine treatment, and 8 participants partially responded. Baseline AMC showed a strong negative correlation with MADRS change at D3 (r=-0.57, p=0.002) and at D18 (r =-0.48, p=0.010), indicating that a high baseline AMC was associated with greater symptom improvement. A generalized linear model confirmed the association of baseline AMC with symptom improvement during ketamine treatment when additionally accounting for age, sex, and body mass index. Specifically, baseline AMC demonstrated predictive value to discriminate responders and partial responders from non-responders, but lacked discriminative ability between partial responders and responders. Baseline ANC correlated with the MADRS changes at D3 (r=-0.39, p=0.046), while CRP values did not correlate at all. Our prospective single-arm open-label observational study demonstrated that baseline AMC reliably predicted symptom improvement during intravenous ketamine treatment in TRD patients. AMC could therefore serve as a simple and easily accessible marker for symptom improvement during ketamine therapy in daily clinical practice. Future studies with larger sample sizes and a more detailed longitudinal assessment of AMC subtypes are needed to better understand the specific relationship between monocytes and the neuromodulatory effects of ketamine.