Search

Abstract Background This multicenter, double-blinded, randomized controlled trial (RCT) aims to assess the impact of an artificial intelligence (AI)-based model on the efficacy of intracranial aneurysm detection in CT angiography (CTA) and its influence on patients’ short-term and long-term outcomes. Methods Study design: Prospective, multicenter, double-blinded RCT. Settings: The model was designed for the automatic detection of intracranial aneurysms from original CTA images. Participants: Adult inpatients and outpatients who are scheduled for head CTA scanning. Randomization groups: (1) Experimental Group: Head CTA interpreted by radiologists with the assistance of the True-AI-integrated intracranial aneurysm diagnosis strategy (True-AI arm). (2) Control Group: Head CTA interpreted by radiologists with the assistance of the Sham-AI-integrated intracranial aneurysm diagnosis strategy (Sham-AI arm). Randomization: Block randomization, stratified by center, gender, and age group. Primary outcomes: Coprimary outcomes of superiority in patient-level sensitivity and noninferiority in specificity for the True-AI arm to the Sham-AI arm in intracranial aneurysms. Secondary outcomes: Diagnostic performance for other intracranial lesions, detection rates, workload of CTA interpretation, resource utilization, treatment-related clinical events, aneurysm-related events, quality of life, and cost-effectiveness analysis. Blinding: Study participants and participating radiologists will be blinded to the intervention. Sample size: Based on our pilot study, the patient-level sensitivity is assumed to be 0.65 for the Sham-AI arm and 0.75 for the True-AI arm, with specificities of 0.90 and 0.88, respectively. The prevalence of intracranial aneurysms for patients undergoing head CTA in the hospital is approximately 12%. To establish superiority in sensitivity and noninferiority in specificity with a margin of 5% using a one-sided α = 0.025 to ensure that the power of coprimary endpoint testing reached 0.80 and a 5% attrition rate, the sample size was determined to be 6450 in a 1:1 allocation to True-AI or Sham-AI arm. Discussion The study will determine the precise impact of the AI system on the detection performance for intracranial aneurysms in a double-blinded design and following the real-world effects on patients’ short-term and long-term outcomes. Trial registration This trial has been registered with the NIH, U.S. National Library of Medicine at ClinicalTrials.gov, ID: NCT06118840 . Registered 11 November 2023.

Achilles tendinopathy is among the most frequent tendon injuries in sport. Despite evidence‐based management, a significant proportion of patients continue to experience symptoms. This is the first randomized trial to investigate the effect of tendoscopic treatment of midportion Achilles tendinopathy compared with placebo at baseline, 3, 6 and 12 months. Patients with midportion Achilles tendinopathy (non‐responsive to more than 6 months of nonsurgical treatments) were randomly assigned to receive either tendoscopic peritendon shaving or placebo tendoscopic treatment. The primary outcome measure was the total score of the Victorian Institute of Sport Assessment Achilles (VISA‐A) questionnaire. Due to three adverse events (sural nerve injuries), in the group receiving tendoscopic treatment, the trial was stopped short of the planned 48 participants. All 23 patients included completed 3 months' follow‐up (100%), 22 (96%) 6 months' and 19 (83%) completed 12 months' follow‐up. The between‐group estimates favored endoscopic treatment and ranged from 19 points (95% confidence interval [CI]: 1–38) at 3 months, 14 points (−7 to 34) at 6 months and 5 points (95% CI: −19 to 28) at 12 months. After 12 months, the tendoscopic group improved 47 points (95% CI: 29–65) versus 40 points (95% CI: 22–57) in the placebo‐operated group. Despite a smaller sample size due to adverse events, VISA‐A indicate faster recovery from tendoscopic treatment compared to placebo. These data suggest that tendoscopic treatment of midportion Achilles tendinopathy should be tested in further research; however, the technique needs to be refined to avoid sural nerve injuries. [ABSTRACT FROM AUTHOR]

Patients with arteriolosclerosis have impaired microvascular perfusion leading to impaired wound healing. Aged garlic extract has shown to have a positive impact on vascular elasticity. The present study aimed to assess the effect of long‐term treatment with AGE on peripheral tissue perfusion in patients with confirmed atherosclerosis. Ninety three patients with a CT‐scan confirmed coronary artery arteriolosclerosis were randomised in a double‐blind manner to placebo or 2400 mg AGE daily for 1 year. Peripheral tissue perfusion was evaluated at 0‐ and 12‐months using Laser Speckle Contrast Imaging. Measurement of post occlusive reactive hyperemia (PORH) and cutaneous vascular conductance (CVC) using acetylcholine iontophoresis (Ach) was conducted. After 12 months a significant increase of 21.6% (95% CI 3.2%‐40.0%, P <.05) was seen in the relative change of PORH in the AGE compared with the placebo group. The same response was seen for CVC and Ach with an increase of 21.4% (95% CI 3.4%‐39.4%, P <.05) in the AGE group compared with the placebo group. Aged garlic extract regenerated peripheral tissue perfusion and increase microcirculation in patients with arteriolosclerosis. Adequate peripheral tissue perfusion and tissue oxygen tension are important prerequisites for successful tissue repair. Restored microcirculation in patients could hypothetically facilitate wound healing. [ABSTRACT FROM AUTHOR]

Laser Doppler velocimetry estimates tissue perfusion providing a record of microvascular blood flow. Patients with heart disease or diabetes mellitus have impaired microvascular perfusion leading to impaired wound healing. Aged garlic extract (AGE) has a positive effect on vascular elasticity. This study aimed to assess the effect of long‐term treatment with AGE on cutaneous tissue perfusion. A total of 122 patients with Framingham Risk Score ≥ 10 were randomised in a double‐blinded manner to placebo or 2400 mg AGE daily for 1 year and monitored. Cutaneous microcirculation was measured at 0 and 12 months using laser Doppler velocimetry. A repeated measures analysis of variance (ANOVA) with a Greenhouse–Geisser correction determined that mean post‐occlusive reactive hyperaemia differed significantly between time points. The mean percent change between the two time points 0 and 12 months was 102, 64 (174, 15)% change for AGE and 78, 62 (107, 92)% change for the placebo group (F[1, 120] = 5. 95, P < 0.016), 12 months of AGE increases the microcirculation in patients with an increased risk for cardiovascular events estimated using the Framingham risk score. Increased microcirculation could hypothetically facilitate wound healing. [ABSTRACT FROM AUTHOR]

Background: Bacterial vaginosis is associated with increased transmission of sexually transmitted infections, preterm labor, post-surgical infections, and endometritis. Current treatment for symptomatic bacterial vaginosis includes antibiotics, such as metronidazole, which are 70-80 % effective at one month after treatment and result in high recurrence rates and secondary candida infections. Intravaginal boric acid has been used for over a hundred years to treat vaginal infections, such as bacterial vaginosis. Boric acid is inexpensive, accessible, and has shown to be an effective treatment for other infections, such as vaginal candidiasis. To date, there has been no clinical trial evaluation of boric acid effectiveness to treat bacterial vaginosis. Methods/Design: The BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) trial is a randomized, double-blinded, multicenter study. The study will enroll a minimum of 240 women of 16-50 years of age who are symptomatic with bacterial vaginosis. Eligible participants will have Amsel and Nugent scores confirming bacterial vaginosis. Women who are pregnant or menopausal or have other active co-infections will be excluded. Consenting participants who meet exclusion and inclusion criteria will be randomly assigned to one of three treatment groups: boric acid, metronidazole, or an inert placebo. Self-administration of treatment intravaginally for 10 days will be followed by clinical assessment at 7 and 30 days (days 17 and 40, respectively) after the end of the treatment phase. Primary outcome is a non-inferiority, per-protocol comparison of the effectiveness of boric acid with that of metronidazole at day 17, as measured by the Nugent score in 16-50 year olds. Secondary outcomes include: non-inferiority, intention-to-treat comparison of effectiveness of boric acid with that of metronidazole at day 17, analysis for both per-protocol and intention-to-treat at day 40, and safety considerations, including adverse effects requiring patient discontinuation of treatment. Discussion: This study will be the first to determine whether intravaginal boric acid is non-inferior to metronidazole in the treatment of bacterial vaginosis in symptomatic women. [ABSTRACT FROM AUTHOR]

Purpose: Acute radiation cystitis, inflammation of the bladder, is a common side effect in men receiving external beam radiation for prostate cancer. Although several treatments provide symptomatic relief, there is no effective treatment to prevent or treat radiation cystitis. Cranberry products have been associated with urinary tract health. This study aimed to determine the effect of highly standardized cranberry capsules (containing 72 mg proanthocyanidins [PACS]) compared with that of placebo capsules on the incidence and severity of radiation cystitis. Methods: Forty-one men with prostate cancer participated in a double blinded randomized placebo controlled study. Men took one capsule a day at breakfast during treatment and for 2 weeks after treatment completion. Severity of urinary symptoms and the bother these caused were measured using the individual items of the urinary domain of the Modified Expanded Prostate Index Composite (EPIC). Results: The incidence of cystitis was lower in men taking cranberry capsules (65 %) compared with those that took placebo capsules (90 %) ( p = 0.058); severe cystitis was seen in 30 % of men in the cranberry arm and 45 % in the placebo arm ( p = 0.30). Overall, the incidence of pain/burning was significantly lower in the cranberry cohort ( p = 0.045). Men on the low hydration regimen who took cranberry had less pain/burning ( p = 0.038), stronger urine steam ( p = 0.030) and used significantly fewer pads/liners ( p = 0.042), which was significantly different from those on the high hydration regimen ( p = 0.028). Conclusion: Men receiving radiation therapy for prostate cancer may benefit from using cranberry capsules, particularly those on low hydration regimens or with baseline urinary symptoms. [ABSTRACT FROM AUTHOR]

Abstract: Ethnophamacological relevance: Bunsimgi-eum (BSGE), a prescription for stagnation of the seven emotions, is being used on neuropsychiatric symptoms in clinical traditional Korean medicine. Aim of the study: The purpose of this research is to examine the effect of BSGE on Hwa-byung''s symptoms. Materials and methods: Randomized, double blinded, placebo-controlled study was set and patients diagnosed as Hwa-byung, were treated with Bunsimgi-eum or controlled medication. Score change of 100mm Visual Analog Scale (VAS) for chest discomfort, Likert scale for major symptom of Hwa-byung, STAXI-K, STAI-K, and BDI-K, were analyzed. Results: 100mm Visual Analog Scale (VAS) for chest discomfort was measured as the 1st evaluative instrument. Experimental group showed greater inclination for score change, but there were no significance. In all other valuation scales, scores improved significantly within each group, but there were no significant difference between the groups. Conclusion: These data show that BSGE''s effect on Hwa-byung did not exceed that of placebo. [Copyright &y& Elsevier]

Background In a recent open pilot trial, R-salbutamol sulphate, a well-known molecule with anti-inflammatory effects, was tested successfully on patients with therapy-resistant discoid lupus erythematosus (DLE). Objectives To compare the efficacy and safety of R-salbutamol cream 0·5% vs. placebo on DLE lesions in a multicentre, double-blinded, randomized, placebo-controlled phase II trial. Methods Thirty-seven patients with at least one newly developed DLE lesion were randomized – 19 to the R-salbutamol cream 0·5% and 18 to placebo – and treated twice daily for 8 weeks. Efficacy was evaluated through scores of erythema, scaling/hypertrophy and induration as well as pain and itching; general improvement scored by the investigator and global improvement scored by patients’ assessment were also evaluated. Results The mean area under the curve of improvement for scaling/hypertrophy, pain, itching and global patient assessment was significantly better for the actively treated patients as compared with placebo (scaling/hypertrophy, P = 0·0262; pain, P = 0·0238; itching, P = 0·0135; global patient assessment, P = 0·045). Moreover, the percentage of patients without induration was significantly higher in the active group compared with the placebo group ( P = 0·013), and a statistically significantly greater decrease in the size of the lesional area was also seen in the overall analysis of the R-salbutamol-treated patients ( P = 0·0197). No serious adverse events were reported. Conclusions Application of R-salbutamol cream 0·5% was safe and well tolerated. Statistically significant effects were seen on scaling/hypertrophy, induration, pain and itching as well as patient global assessment, suggesting that R-salbutamol could be a promising new topical therapy alternative for DLE. [ABSTRACT FROM AUTHOR]