Search PubMedSearch

SEARCH · Search PubMed

Results for “list randomization”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

1,220 records · Page 4Linked to original sources

Oblique Lateral Interbody Fusion With Lateral Vertebral Screw Fixation Versus Transforaminal Lumbar Interbody Fusion for Severe Lumbar Stenosis: Results of a Multicenter Randomized Controlled Trial.

BACKGROUND AND OBJECTIVES: The benefits of oblique lateral interbody fusion (OLIF) vs transforaminal lumbar interbody fusion (TLIF) in severe lumbar stenosis (Schizas C/D) remain uncertain. This randomized trial compared clinical, radiographic, and safety outcomes of OLIF and TLIF. METHODS: From November 2018 to December 2021, a prospective, multicenter, randomized controlled trial enrolled 260 adults with single-level severe stenosis and instability. In total, 224 patients were randomized to OLIF or TLIF. Prespecified outcomes followed consolidated standards of reporting trials. Primary outcomes were visual analog scale back/leg pain and Oswestry Disability Index (ODI), with minimal clinically important difference thresholds of ODI &#x2265;12-13 points or &#x2265;30% improvement, and visual analog scale &#x2265;1.5-2.0 points. Radiographic measures included disc height, lumbar and segmental lordosis, and canal cross-sectional area (CSA). Complications were recorded. Ethics approval was obtained from the institutional review board, the trial was registered with ISRCTN.com , and all patients provided written informed consent. RESULTS: In total, 224 patients were randomized, 5 were lost to follow-up (TLIF n = 2, OLIF n = 3). Baseline features were comparable. OLIF was associated with shorter operative time, less blood loss, earlier ambulation, and shorter hospital stay (all P < .05). Both groups achieved significant, clinically meaningful improvements. OLIF showed greater back pain reduction at 3-6 months and 2 years ( P < .05) and superior ODI improvement at 3 and 6 months ( P < .001), although long-term ODI scores were similar. Radiographically, OLIF provided greater restoration of disc height and segmental lordosis (all P < .001) and demonstrated progressive CSA increase (dynamic decompression), whereas TLIF achieved immediate, sustained CSA enlargement. Fusion rates were comparable at 1-2 years. Complication rates were low and similar (7.3% TLIF vs 5.5% OLIF), with most OLIF-specific events transient. CONCLUSION: Both OLIF and TLIF yield improvements in severe lumbar stenosis. OLIF offers perioperative advantages, earlier functional recovery, radiographic restoration, and dynamic canal remodeling, supporting its role as an equivalent alternative for lumbar spinal stenosis with some secondary advantages.

Humans

Effect of flavored on!&#xae; nicotine pouch products on smoking behaviors: A sequential, multiple assignment, randomized controlled trial.

PURPOSE: To evaluate whether flavored versus unflavored nicotine pouch (NP) access affects cigarette reduction and smoke exposure among adults who smoke daily, and whether delayed flavor introduction affects these outcomes. METHODS: Adults who smoked &#x2265;&#x2009;5 cigarettes/day (CPD) with interest in replacing cigarettes with NPs were enrolled in a remote, six-week, sequential multiple assignment randomized trial (n&#x2009;=&#x2009;402 randomized; n&#x2009;=&#x2009;400 analyzed). Participants were randomized to immediate access to seven NP flavors (Flavor), unflavored-only access for six weeks (Original), or unflavored-only for three weeks followed by flavor access (Delayed Flavor). Primary outcomes were &#x2265;&#x2009;50% reduction in weekly mean expired-air carbon monoxide (CO) from baseline and mean CO at Week 6. Secondary outcomes included &#x2265;&#x2009;50% CPD reduction, mean CPD, CO-verified 7-day abstinence, and incident smoke-free days. RESULTS: At Week 6, Flavor and Original did not differ in &#x2265;&#x2009;50% CO reduction (14.3% vs 14.2%; IRR=1.0, 95% CI=0.6-1.8) or mean CO (18.3 vs 16.5&#x2009;ppm; &#x3b2;=1.9, 95% CI=-1.3-5.0). CPD decreased across groups by Week 6, with no differences between Flavor and Original in &#x2265;&#x2009;50% CPD reduction (50.3% vs 51.6%; IRR=1.0, 95% CI=0.8-1.2) or CO-verified abstinence (9.3% vs 8.9%; IRR=1.0, 95% CI=0.5-2.2). Flavor increased smoke-free days early, with attenuation over time. Among Week 3 non-responders, delayed flavor access increased &#x2265;&#x2009;50% CPD reduction at Week 6 (33.3% vs 18.6%; IRR=1.8, 95% CI=1.0-3.2). CONCLUSIONS: NP access supported cigarette reduction regardless of flavor availability, but flavors may accelerate smoke-free days and improve response among individuals who do not reduce cigarette consumption with unflavored products alone.

Humans

USleep: efficacy of app-based audio interventions to improve sleep disturbance in working adults, a multi-arm randomized controlled trial.

STUDY OBJECTIVES: To evaluate the efficacy of three categories of standalone, audio-based sleep interventions (Bedtime Stories, Sleep Sounds, Sleep Skills) delivered via mental health application (MHapp) in improving sleep among working adults with sleep disturbance. METHODS: A multi-arm, parallel randomized controlled trial was conducted. Adults with self-reported sleep disturbances were recruited online and randomly allocated to Bedtime Stories, Sleep Sounds, Sleep Skills, or digital control. Participants completed self-report questionnaires on sleep disturbance and other related outcomes at baseline (t0) and after the 4-week intervention (t1). The primary analysis followed an intention-to-treat approach using mixed-effects models. RESULTS: A total of 495 working adults (mean age&#x2009;=&#x2009;32.7&#xa0;years; 55.8% female) were randomized. For sleep disturbance (primary outcome), the between-group Hedges' g effect sizes were very small and not statistically significant (Bedtimes stories vs. control: g&#x2009;=&#x2009;0.12, 95% CI -0.13 to 0.37, Sleep Sounds vs. control: g&#x2009;=&#x2009;0.14, 95% CI -0.11 to 0.39, Sleep Skills 0.07, 95% CI -0.07 to 0.29), with slightly greater reductions in sleep disturbance for the intervention groups than control. The same pattern was observed for sleep-related impairment, mental health, well-being, and pre-sleep arousal. CONCLUSION: Audio-based sleep interventions delivered via a MHapp did not demonstrate superior efficacy over a digital control condition in reducing self-reported sleep disturbance among working adults. Although safe and well-tolerated, their use as standalone treatments for sleep disturbance is not supported by these findings. Future research should explore effectiveness in real-world settings, including user content choice across categories, and use objective sleep measures. CLINICAL TRIAL REGISTRATION: Registered at https://www.isrctn.com/ under "Evaluating the efficacy of audio-based digital tools to improve sleep on the Unmind workplace well-being platform"; https://www.isrctn.com/ISRCTN13426045; registration number: 13426045.

Humans

Magnesium administration for vasospasm prevention in acute aneurysmal SAH: a multicenter randomized controlled trial.

Aneurysmal subarachnoid hemorrhage (aSAH) is associated with significant morbidity and mortality, with cerebral vasospasm (CV) and delayed cerebral ischemia (DCI) being the primary contributors to poor outcomes. Magnesium sulfate (MgSO&#x2084;) has demonstrated neuroprotective and vasodilatory properties in preclinical models. This study aimed to evaluate the effect of targeted serum magnesium (Mg) maintenance on CV and exploratory clinical outcomes following aSAH. We conducted a prospective, multicenter, single-blind RCT across four neurocritical care units in Korea between 2019 and 2024. A total of 121 aSAH patients were randomized to receive either IV MgSO&#x2084;or placebo within six hours of admission. Mg was infused to maintain serum concentrations between 2.0 and 3.0 mg/dL for 14 days. The primary outcome was incidence of CV assessed by transcranial doppler. Secondary outcomes included DCI, ICU and hospital length of stay, modified rankin scale (mRS) at 30 days. There was no significant difference in overall CV incidence; however, the Mg group demonstrated significantly lower mean flow velocity and Lindegaard ratio on days 4-9, indicating reduced vasospasm severity. In exploratory multivariable analyses, a median serum Mg concentration&#x2009;>&#x2009;2.5 mg/dL during the first 14 hospital days was independently associated with lower risks of CV and DCI. No significant differences were found in mRS scores, ICU and hospital stay, or serious adverse events between groups. Early targeted Mg administration improved TCD-derived hemodynamic markers during the peak vasospasm window; however, it did not significantly reduce CV incidence, DCI, ICU or hospital stay, or 30-day functional outcome.

Humans

Effects of Cognitive Behavioral Couple Therapy With Integrated Mindfulness on Mindful Attention, Depressive Symptoms, and Dyadic Adjustment in Low-Income Couples: A Pilot Randomized Clinical Trial.

Psychosocial distress can exacerbate marital conflict, maladjustment, and mental health vulnerability. This pilot randomized clinical trial examined cognitive-behavioral couple therapy (CBCT) integrated with mindfulness in low-income Brazilian couples (per-capita household income up to one minimum wage). Thirty-four participants (17 heterosexual couples) were randomized (independent computer-generated sequence) to an experimental (n&#x2009;=&#x2009;16) or waitlist control group (n&#x2009;=&#x2009;18). We assessed dyadic adjustment, mindful attention, marital social skills, and depressive symptoms (R-DAS, MAAS, IHSC, BDI-II) at baseline, post-treatment, and 3-month follow-up. The intervention was eight 80-min conjoint sessions plus daily home exercises. Time&#x2009;&#xd7;&#x2009;group effects favored the experimental group for dyadic adjustment, mindful attention, and depressive symptoms (all p&#x2009;<&#x2009;0.001,&#x2009;=&#x2009;0.20-0.37), but not marital social skills (p&#x2009;=&#x2009;0.14). Because two outcomes differed at baseline, effects were confirmed with baseline- and dependence-adjusted sensitivity analyses. These findings provide preliminary evidence that CBCT with mindfulness may benefit disadvantaged couples.

Adult

A Randomized Clinical Trial to Compare Moxifloxacin Versus Azithromycin for the Treatment of Mycoplasma genitalium: The FARTHEST Study.

BACKGROUND: Mycoplasma genitalium (MG) is increasingly characterized by high rates of macrolide and fluoroquinolone resistance. International guidelines recommend resistance-guided therapy; however, access to genotypic testing is limited, and randomized trial evidence is lacking. We assessed the efficacy of moxifloxacin and azithromycin without resistance assays. METHODS: This monocentric, open-label, superiority, randomized controlled trial enrolled adults with MG infection detected by multiplex PCR, randomized 1:1 to receive moxifloxacin 400 mg daily for 10 days or azithromycin 500 mg daily for 6 days. A test of cure was performed &#x2265;28 days after treatment completion. The primary endpoint was microbiological cure in the intention-to-treat (ITT) and per-protocol (PP) populations. Subgroup analyses assessed symptomatic versus asymptomatic infections, doxycycline exposure, re-treatment, and sexual behavior. RESULTS: Among 358 randomized participants, 87.0% of those treated with moxifloxacin and 61.2% of those treated with azithromycin achieved microbiological cure in the ITT analysis (absolute risk difference 25.8%, 95% CI 16.5, 35.2). The superiority of moxifloxacin was confirmed in the ITT and PP populations. Moxifloxacin remained superior across most subgroups, whereas azithromycin showed comparable efficacy only among heterosexual individuals. Doxycycline coadministration did not improve outcomes. Both regimens were well tolerated, with only one case of discontinuation. CONCLUSIONS: Moxifloxacin demonstrated superior efficacy compared to azithromycin for treating MG infection in the absence of resistance testing. These randomized data support the use of moxifloxacin as a first-line option when resistance assays are unavailable and may inform treatment strategies.

Humans

Effects of exercise on aerobic capacity in people with prehypertension or hypertension: a systematic review and meta-analysis of randomized controlled trials.

This study aimed to quantify the effects of exercise on aerobic capacity in people with prehypertension or hypertension and to identify exercise prescription parameters that optimize improvements. A comprehensive search was conducted in PubMed, Web of Science, Embase, Cochrane Library, and Scopus from inception to 24 October 2025. Data were pooled using standardized mean differences (SMDs) with 95% confidence intervals (CI). Fifteen studies met the inclusion criteria. Exercise significantly improved aerobic capacity in people with prehypertension or hypertension (SMD&#x200a;=&#x200a;0.88; 95% CI: 0.61-1.15; P &#x200a;<&#x200a;0.00001), with multicomponent training demonstrating superior efficacy. Exploratory subgroup analyses suggest that longer programs (&#x2265;12&#x200a;weeks), lower frequency (<3&#x200a;sessions/week), 60-min sessions or longer, total weekly exercise less than 180&#x200a;min, and professional supervision may be associated with better outcomes.

Humans

A flipped classroom approach compared with low-interactive online learning for pediatric pain management knowledge and instructional motivation in nursing students: A randomized controlled study.

AIM: This study aimed to compare a flipped classroom approach with low-interactive online learning in terms of nursing students' questionnaire-assessed pediatric pain management knowledge and instructional motivation. BACKGROUND: Pain management in children is a critical and multidimensional nursing responsibility. However, limited curricular time and opportunities for applied learning may restrict nursing students' preparedness in this area. Structured and interactive instructional formats, such as the flipped classroom, may support knowledge acquisition and motivation in pediatric nursing education. METHODS: This study employed a parallel-group randomized controlled trial design with a 1:1 allocation ratio. Eighty-eight third-year prelicensure nursing students were randomized to either the flipped classroom group (n&#xa0;=&#xa0;44) or the low-interactive online learning group (n&#xa0;=&#xa0;44). Due to attrition (2 intervention, 2 control), analyses included 42 participants per group (n&#xa0;=&#xa0;84 in total). Data were collected between February and July 2022 using the Pediatric Pain Management Knowledge Scale for Nursing Students and the Instructional Materials Motivation Survey. This study was prospectively registered at ClinicalTrials.gov (Identifier: NCT07129044). RESULTS: At baseline, the groups were comparable in terms of knowledge and learning motivation. Following the intervention, the flipped classroom group demonstrated greater improvements in questionnaire-assessed pediatric pain management knowledge and instructional motivation than the low-interactive online learning group. Although scores declined from post-test to the three-month follow-up, they remained above baseline in the flipped classroom group. CONCLUSIONS: Within the context of this course, the flipped classroom approach was associated with greater improvement in questionnaire-assessed pediatric pain management knowledge and instructional motivation than low-interactive online learning. The findings should be interpreted as proximal educational outcomes rather than evidence of improved clinical competence or durable long-term effectiveness. Further studies using objective performance-based outcomes and longer follow-up periods are needed.

Humans

Exercise prehabilitation in head and neck cancer patients proposed for definitive chemoradiotherapy: The FIT4TREAT randomized controlled trial.

BACKGROUND: Patients with head and neck cancer (HNC) initially scheduled for definitive chemoradiotherapy (CRT) often experience early functional decline and deterioration in health-related quality of life (HRQoL) even before treatment initiation. Evidence for prehabilitation in this non-surgical setting remains limited. This study evaluated whether exercise prehabilitation (EP) initiated before CRT improves functional capacity compared with usual care (UC). METHODS: FIT4TREAT (ClinicalTrials.gov: NCT05418842) was a prospective, single-center, randomized clinical trial. Adults with HNC proposed for definitive CRT were randomly assigned (1:1) to EP or UC. EP consisted of supervised combined aerobic and resistance exercise performed three times per week from baseline until radiotherapy initiation. The primary outcome was the six-minute walk distance (6MWD) at the end of the pre-treatment period. Secondary outcomes included muscle strength, lower-limb functionality, body composition, and HRQoL assessed using the EORTC QLQ-C30 and QLQ-HN43. RESULTS: Between May 2021 and February 2025, 47 patients were enrolled; 40 were included in the primary analysis. After adjustment for baseline 6MWD and the randomization stratification variables, EP resulted in a significantly greater pre-treatment 6MWD than UC (adjusted between-group difference, 28.6&#xa0;m; 95&#xa0;% CI, 4.1-53.1; P&#xa0;=&#xa0;0.023). EP also improved lower-limb functionality (P&#xa0;<&#xa0;0.001) and was associated with better preservation in the QLQ-C30 summary score (P&#xa0;=&#xa0;0.008), social functioning (P&#xa0;=&#xa0;0.038) and body image (P&#xa0;=&#xa0;0.011). CONCLUSION: EP before definitive CRT improves functional capacity and may help preserve HRQoL in patients with HNC, supporting its potential integration into routine oncology care.

Humans

Efficacy of a multimodal conservative rehabilitation program for bladder control in individuals with incomplete spinal cord injury: A randomized controlled trial.

ObjectiveThe study aimed to evaluate the efficacy of a multimodal intervention on urodynamic outcomes, urinary incontinence severity, and pelvic floor muscle strength in individuals with overactive bladder after incomplete spinal cord injury.MethodsA single-blind randomized controlled trial was conducted on 74 male participants diagnosed with overactive bladder and incomplete spinal cord injury. Participants were randomly assigned to an experimental group or a control group. Treatment was conducted for 8 weeks, three sessions per week. Outcomes were assessed at baseline, post-intervention, and the 8-week follow-up.ResultsThe experimental group showed significantly greater improvements in the measured outcomes compared with the control group (P&#x2009;<&#x2009;0.001).ConclusionIncorporating a multimodal regimen demonstrated significant efficacy in enhancing bladder capacity, continence, and muscle function in individuals with overactive bladder due to incomplete spinal cord injury.Clinical trial registry (ID: NCT07008157).https://clinicaltrials.gov/study/NCT07008157?cond=Spinal%20Cord%20Injuries&intr=Multimodal%20Rehabilitation%20Program&viewType=Card&rank=1.

Humans

Ketamine assisted psychotherapy to reduce chronic neuropathic pain: A mixed-methods randomized pilot trial.

BACKGROUND: Intravenous ketamine can provide short-term analgesia in chronic neuropathic pain but benefits often wane after treatment. We conducted a randomized pilot trial to assess the feasibility of combining ketamine infusions with psychotherapy to inform future efficacy trials. METHODS: In this single-center, randomized, outcome-assessor-blinded pilot trial at a Canadian tertiary pain clinic, adults with moderate-to-severe chronic neuropathic pain were randomly assigned in 1:1:1 ratio to the ketamine, psychotherapy, or combined ketamine plus psychotherapy arm. Ketamine was delivered as three intravenous infusions over 16 weeks; psychotherapy consisted of 16 weekly cognitive behavioral therapy and mindfulness-based meditation sessions. The primary outcome was feasibility, assessed using prespecified progression criteria. Exploratory outcomes included changes in pain interference (PROMIS 6a T-score), pain intensity, mood, and qualitative interview findings at week 20 (ClinicalTrials.gov: NCT05639322). FINDINGS: Between October 23, 2023, and March 31, 2025, 30 participants were randomized, and 26 (87%) completed 20-week follow-up. Most feasibility criteria, including consent, retention, data completeness, and absence of study-related serious adverse events, were met; adherence targets were partially met. Exploratory pain outcomes showed numerical improvement across groups, with clinically meaningful reductions observed for pain interference and pain intensity. Sixty-four adverse events were recorded, mostly mild and in ketamine-containing groups; no serious study-related adverse events occurred. CONCLUSIONS: Combined ketamine and psychotherapy was feasible and acceptably safe in this pilot trial, supporting evaluation in a larger efficacy-powered study. FUNDING: The study was funded by the St. Michael's Hospital Innovation Fund, The Canadian Pain Society Early Investigator Award and the Physician Services Incorporation Early Career Researcher Award.

Humans

Comparative efficacy of LDL-C-lowering therapies in first-time vs. recurrent myocardial infarction prevention: a meta-analysis of large-scale randomized controlled trials.

AIMS: Reducing elevated low-density lipoprotein cholesterol (LDL-C) is central to global efforts to prevent myocardial infarction (MI). While many studies have evaluated LDL-C-lowering therapies in first-time and recurrent MI prevention, direct comparisons of their relative efficacy are lacking. Therefore, we conducted a systematic review and meta-analysis to compare the efficacy of LDL-C-lowering therapies in first-time vs. recurrent MI prevention. METHODS AND RESULTS: We searched three databases until 30 November 2024, for randomized controlled trials (RCTs) with at least 1000 patient-years of follow-up. Efficacy was quantified as relative risk (RR) with 95% confidence intervals (CIs). Differences in benefit magnitude were assessed using Cochran's Q test. Data were pooled with a random-effects model, and heterogeneity was measured using the I2 statistic. Additionally, we applied the Cochrane Risk of Bias Tool to evaluate study quality and utilized the GRADE method to assess the certainty of the evidence. This study included 22 large-scale RCTs involving 180 304 participants. In first-time MI prevention, LDL-C-lowering therapies achieved a remarkable 38% reduction in MI risk [12 RCTs; 79 604 participants; RR, 0.62 (95% CI, 0.55-0.69); P < 0.001]. In recurrent MI prevention, these therapies were associated with a more modest but significant 16% risk reduction [11 RCTs; 100 700 participants; RR, 0.84 (95% CI, 0.80-0.88); P < 0.001]. Importantly, the benefit magnitude between the two groups was significantly different (Q = 22.63; P < 0.001), highlighting the greater relative benefit in first-time MI prevention. Furthermore, the robustness of our findings was consistently supported by leave-one-out analyses, the absence of publication bias, high-quality GRADE evidence, and subgroup and sensitivity analyses. CONCLUSION: Our findings suggest that LDL-C-lowering therapies may offer a greater benefit in preventing first-time MI compared with recurrent MI.

Humans

Effect of self-activating phthalocyanine gel on palatal donor site healing, inflammatory biomarkers, somatosensory and patient-centered outcomes: a randomized split-mouth clinical trial.

OBJECTIVES: To evaluate effects of self-activating phthalocyanine (PHY) gel on palatal donor site after subepithelial connective tissue graft (SCTG) harvesting, considering clinical outcomes, inflammatory biomarkers, patient-centered outcomes, and quantitative somatosensory changes. MATERIALS AND METHODS: Twenty participants were included in this randomized, crossover, split-mouth clinical trial. Donor sites received topical PHY gel (PHY group-PHYG) and placebo gel (control group-CG). Clinical parameters (residual wound area-RWA, wound epithelialization-WE, residual remodeling area-RRA and tissue thickness-TM) were assessed at baseline, 7, 14, 30, and 60 days. Patient-centered outcomes were recorded during 14 postoperative days and inflammatory biomarkers at 3 and 7 days postoperatively. Mechanical detection threshold (MDT) and mechanical pain threshold (MPT) were evaluated at baseline, 2 months, and 6 months. RESULTS: PHYG and CG exhibited similar clinical outcomes, but PHYG demonstrated superior performance in reducing RRA. Both groups presented positive postoperative progression of patient-centered outcomes. IL-10 levels showed a significant increase in PHYG, suggesting a more favorable anti-inflammatory response. MDT remained stable but, donor sites exhibited transient hypersensitivity (MPT) at 2 months. CONCLUSIONS: PHYG and CG protocols promoted satisfactory healing of palatal donor sites. Most clinical parameters and patient-centered outcomes were similar between groups. The PHYG presented reduced RRA and increased IL-10 levels. Donor sites exhibited transient hypersensitivity, which tended to resolve over time. CLINICAL RELEVANCE: Both postoperative protocols resulted in favorable healing of palatal donor sites following SCTG harvesting, with comparable clinical and patient-centered outcomes. Quantitative sensory testing indicates that hypersensitivity may occur during healing, but sensory function tends to recover progressively.

Humans

Virtual Reality Education for Hospitalized Pediatric Patients Improves Intrinsic Motivation: A Prospective, Randomized Crossover Study.

Hospitalized children experience educational disruption and reduced motivation during prolonged admissions. Despite the availability of in-hospital schools, many cannot participate due to illness severity or isolation precautions. This pragmatic, randomized crossover trial evaluated whether bedside virtual reality (VR) lessons improve intrinsic motivation among inpatients aged 5 to 25 years unable to attend the hospital school. Participants completed both VR-based educational sessions and standard of care (SOC) conditions on consecutive days. The primary outcome was intrinsic motivation, with secondary outcomes including educational self-efficacy, well-being, self-esteem, and parental experience. Of 156 enrolled patients, 100 were analyzed (mean age 11.5 [SD = 4.1 years]; 43.9% female). Intrinsic motivation scores were higher in the VR condition than SOC (P = .0048), and parental satisfaction was also greater (P = .0008). Bedside VR education represents a feasible, acceptable, and scalable adjunct to inpatient learning, supporting intrinsic motivation and caregiver satisfaction during hospitalization.Trial Registration: ClinicalTrials.gov NCT05725395, date first registered November 22, 2022.

Humans

HPV Testing Versus Cytology for Cervical Cancer Screening&#xa0;Among Women 50&#x2009;Years and Older: Evidence From the HPV FOCAL Randomized Controlled Trial.

Evidence on the comparative effectiveness of HPV testing versus cytology specifically in women aged &#x2265;&#x2009;50&#x2009;years who are approaching screening cessation remains limited. This analysis included 6471 women aged &#x2265;&#x2009;50 at baseline screening in the HPV FOCAL randomized clinical trial. Women were randomly allocated to receive cytology (Control Group, n&#x2009;=&#x2009;3248, 50.19%) or HPV testing (Intervention Group, n&#x2009;=&#x2009;3223, 49.81%) at baseline, with co-testing at 48-month exit. We calculated incidence rates and risk ratios for CIN2+ detection over follow-up and compared missed lesions at exit by screening method. At the 48-month exit, CIN2+ detection was lower among HPV baseline-negative women than among those in the cytology group (1.61/1000 [95% CI, 0.52-3.76] vs. 3.15/1000 [95% CI, 1.51-5.78]; risk ratio, 0.51 [95% CI, 0.11-0.91]), reflecting higher baseline detection with HPV testing and fewer prevalent lesions at exit. Even with cytology re-screening at 2&#x2009;years, 50% of CIN2+ cases were missed compared to 30% with HPV testing. After adjusting for age, education, smoking status, and lifetime sexual partners, the hazard ratio for CIN2+ comparing HPV to cytology was 0.44 (95% CI, 0.22-0.88). Among women aged &#x2265;&#x2009;50&#x2009;years, HPV primary screening was more effective than cytology at detecting CIN2+ lesions and was associated with a continued lower subsequent risk following a negative HPV test, supporting its use in cervical cancer screening programs in this age cohort.

Aged

Liposomal bupivacaine versus ropivacaine for surgical site infiltration in lumbar fusion: a prospective randomized controlled trial.

INTRODUCTION: Effective postoperative pain control after lumbar spine surgery remains challenging, and excessive opioid use is associated with adverse outcomes. Evidence comparing liposomal bupivacaine (LB) with conventional long-acting local anesthetics in spine surgery is limited. PATIENTS AND METHODS: In this single-center, prospective, randomized, patient- and outcome assessor-blinded trial, adult undergoing one- or two-level posterior lumbar decompression and fusion were assigned (1:1) to surgical site infiltration with either LB (266&#x2009;mg) plus 25&#x2009;mg plain bupivacaine (LB group) or ropivacaine (R group). The primary outcome was 72&#x2009;h cumulative opioid consumption (morphine milligram equivalents, MME). Secondary outcomes included time-profile opioid consumption, pain scores, rescue analgesia, safety, and functional recovery. RESULTS: A total of 202 patients were included in the modified intention-to-treat analysis. Cumulative MME within 72&#x2009;h was significantly lower in the LB group compared with the R group [43.0 (37.0, 58.0) mg vs. 58.0 (46.0, 73.0) mg], corresponding to a 22% relative reduction (GMR 0.78, 95% CI 0.71-0.85; p&#x2009;<&#x2009;0.001). The reduction was most pronounced during 8-24&#x2009;h and 24-48&#x2009;h postoperatively. Overall pain scores at rest and with movement, as well as 72-h pain AUC, were lower in the LB group. No significant between-group differences were observed in rescue analgesia, adverse events and functional recovery. CONCLUSION: In patients undergoing one- or two-level posterior lumbar decompression and fusion, surgical site infiltration with an LB-based combined regimen, compared with ropivacaine monotherapy, reduced 72-h opioid consumption and cumulative postoperative pain burden without an observed increase in adverse events or impairment of early functional recovery.

Humans

Effectiveness of psychologically informed physical therapy, tendon-specific exercise program and routine physical therapy in prolonged unilateral shoulder pain and symptom correlations with imaging: a single-center, randomized, parallel-group, three-arm study (RESPECT).

BACKGROUND: Shoulder complaints are one of the most common musculoskeletal ailments. Patient-specific characteristics such as obesity, depression and physical labor are established risk factors, whereas imaging findings are common and associations between specific imaging findings and symptomatology is limited. General exercises are considered useful in treatment whereas evidence for specific tendon exercises is lacking. Biopsychosocial model is also recommended, but has not been extensively studied concerning shoulder symptoms. This article describes the study protocol designed to evaluate the effectiveness and the cost-effectiveness of routine and specific physical therapy (PT) interventions. Imaging is performed for descriptive, longitudinal and imaging-symptom correlation studies. METHODS: The Rehabilitation of Shoulder Pain: Evaluation and Clinical Trial (RESPECT) is a randomized three-arm parallel-group study involving 300 participants aged 20 to 60&#xa0;years with prolonged unilateral shoulder pain. Participants will receive either routine PT, physiotherapist-guided tendon-specific exercise program or psychologically informed PT. Bilateral shoulder radiographs, ultrasound and magnetic resonance imaging will be done at the baseline and at 12 and 36&#xa0;months. Electronic surveys will be completed at the baseline and at 3, 6, 12 and 36&#xa0;months. The primary outcome will be patient-specific functional scale (PSFS) at 12&#xa0;months, analyzed using analysis of covariance (ANCOVA), adjusted for baseline PSFS. DISCUSSION: RESPECT will provide systematic and controlled data regarding different PT interventions in prolonged shoulder symptoms, which is currently limited. Being one of the most common sources of musculoskeletal pain, improved management could reduce symptom-related burden and prolonged functional impairment at individual and population level. CLINICALTRIALS: gov; Registration number NCT07235969; Registered November 18th, 2025; Version: 1.0.

Humans

Symptoms and treatment response to florensocatib and inhaled tobramycin in bronchiectasis: Post hoc analysis of two randomized trials.

Inhaled antibiotics and DPP-1 inhibitors improve clinical outcomes in bronchiectasis, but whether baseline symptom burden predicts differential treatment responses remains unclear. In this post hoc analysis of two multicenter randomized trials (SAVE-BE, n = 224; TORNASOL, n = 357), we evaluate the association between baseline Quality of Life-Bronchiectasis Respiratory Symptom Scale (QoL-B-RSS) and treatment effects of florensocatib and inhaled tobramycin. In SAVE-BE, florensocatib reduces exacerbation rates versus placebo (relative risk [RR], 0.47; 95% confidence interval [CI], 0.33-0.67; p < 0.0001), with RRs of 0.53 and 0.40 observed in patients with high and low symptom burdens, respectively, but no significant symptomatic improvement. In TORNASOL, tobramycin produces clinically meaningful QoL-B-RSS improvements (exceeding the 8-point cutoff in high-symptom patients) and ameliorates bronchitic symptoms, with greater benefits in those with higher baseline symptom burden. These hypothesis-generating findings suggest that baseline symptom burden may identify differential responses to anti-inflammatory versus anti-infective therapies in bronchiectasis and support its potential as a simple, practical stratification tool to guide personalized treatment.

Humans