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Helical intensity-modulated radiation therapy vs. C-arm-based volumetric modulated arc therapy for sinonasal tumours: organ at risk sparing and treatment efficiency.

BACKGROUND AND PURPOSE: Sinonasal tumours present major radiotherapy challenges because of their proximity to the optic nerves, chiasm, and brainstem. This study aimed to evaluate helical intensity-modulated radiation therapy (HIMRT) and volumetric modulated arc therapy (VMAT), including coplanar and noncoplanar approaches, by integrating plan quality and treatment efficiency. MATERIALS AND METHODS: A retrospective planning analysis of 467 patients with sinonasal tumours was conducted using HIMRT and VMAT planning techniques, whereby HIMRT with jaw widths of 1.0, 2.5, and 5.0 cm were compared

Effects of Oxygen-Ozone Therapy and Physiotherapy on Functioning in Patients with Chronic Non-Specific Neck Pain: A Prospective Double-Arm Pilot Study.

Objectives: This study aimed to evaluate the effects of a combined treatment consisting of O2O3 injections and McKenzie-based physiotherapy exercises, compared to a Control group treated with O2O3 injections and a Back School physiotherapy program, in reducing pain and disability in individuals with chronic non-specific neck pain. Methods: In this prospective double-arm pilot study, patients with chronic non-specific neck pain and a Numerical Rating Scale (NRS) > 4 were enrolled. All patients received eight weekly sessions of O2O3 injections (10 μg/mL, 10 mL total, and 2 mL bilaterally into th…

Intraoperative C-arm CBCT versus early postoperative MRI for the assessment of fracture reduction and osteosynthesis material positioning in cranio-maxillofacial trauma surgery.

PURPOSE: To compare intraoperative C-arm cone-beam computed tomography (CBCT) with dedicated in-house-optimized magnetic resonance imaging (MRI) protocols, including CT-like and metal artifact reduction sequences (MARS), using a novel 15-channel coil for the evaluation of fracture reduction, osteosynthesis material positioning, and the depiction of plates and screws. METHODS: Fifteen patients (13 men, 2 women; median age, 32 years; range, 18-65 years) with acute cranio-maxillofacial fractures underwent surgical treatment with intraoperative CBCT, followed by early postoperative MRI within 36 …

Factors contributing to the variability of anterior overbite opening after standardized posterior bite raiser placement: a prospective single-arm pre-post clinical study.

BACKGROUND: Posterior bite raisers are frequently used in orthodontics, yet the magnitude of the resulting anterior overbite change shows substantial interindividual variability. This study aimed to identify dental and cephalometric characteristics that explain interindividual variability in anterior overbite opening following standardized posterior bite raiser placement. METHODOLOGY: Forty-seven subjects (7-56 years of age) with a recent lateral cephalogram were recruited. Digital intraoral impressions of the dentition were taken before and after temporary placement of a 2mm-diameter stainle

Efficacy and Safety of Pamiparib Monotherapy in Recurrent Ovarian Cancer After Prior PARPi Exposure: A Prospective, Open-Label, Single-Arm, Phase II Study.

AIM: To evaluate the efficacy and safety of pamiparib monotherapy in recurrent ovarian cancer (rOC) after prior PARPi exposure. METHODS: This was a prospective clinical trial. Fifteen patients were enrolled between August 2022 and December 2023. Oral pamiparib 60 mg twice daily was administered until conditions specified in the protocol. Primary endpoint was clinical benefit rate ≥ 4 months (CBR4m; percentage of patients who sustained complete response, partial response [PR], and stable disease for at least 4 months). Secondary endpoints included progression-free survival (PFS), overall respo

Preliminary feasibility and safety of domestic probe-based confocal laser endomicroscopy in the diagnosis of bladder lesions: a prospective single-arm cohort study.

BACKGROUND: White light cystoscopy (WLC), the first-line diagnostic modality for bladder lesions, has inherent limitations in detecting flat … condary outcomes) to inform future clinical research. METHODS: A single-center, prospective single-arm cohort study was conducted at a tertiary hospital, enrolling 10 patients with suspected bladder masses or a history of bladder cancer undergoing cystoscopy. Feasibility was defined as the technical completion rate of pCLE imaging, and safety was eva …

Эффективность и безопасность Belantamab Mafodotin с Бортезомибом плюс Dexametasone у пациентов с повторной/отправленной миеломой: DREAMM-6 Судебное разбирательство по делу Б.

ЦЕЛЬ: Этап I/II DREAMM-6 ручка В (измерение)NCT03544281) исследованный белантамб мафодотин в сочетании с бортезомиб/дексаметазоном (BVd) в регрессивной/редактированной множественной миеломе (RRMM). ПАТИЕНТЫ И МЕТОДЫ: Взрослые с RRMM последовательно зачислялись в учебные заведения two belantamab mafodotin (внутренний) когорты " доза-эскалация " (DE)2.5 Тогда 3.4 мг/кг каждый 3 Неделями). Дополнительные пациенты, зачисленные в eight Классы " доза-расширение " : 1.9, 2.5, или 3.4 мг/кг каждый 3 недель; 2.5 или 3.4 мг/кг каждый 3 :: разделение недель (сутки) 1 и 8); 1.9 или 2.5

Совпадение в аннотации оригинала
PURPOSE: The phase I/II DREAMM-6 arm B study (NCT03544281) explored belantamab mafodotin combined with bortezomib/dexamethasone (BVd) in relapsed/refractory multiple myeloma (RRMM). PATIENTS AND METHODS: Adults with RRMM were enrolled sequentially in two belantamab mafodotin (intravenous) dose-escalation (DE) cohorts (2.5 then 3.4 mg/kg every 3 weeks). Addi…

Yoga Nidra Versus Music Therapy for Sleep and Mental Well-being in Post-COVID-19 Hospitalised Patients: A Three-arm Randomised Controlled Trial.

BACKGROUND: The COVID-19 pandemic has resulted in a significant increase in mental health issues, including depression, anxiety, post-traumatic stress disorder and sleep disturbances, particularly among recently hospitalised patients. Non-pharmacological interventions such as Yoga Nidra and Music Therapy offer cost-effective and accessible alternatives for improving psychological well-being and sleep quality in this population. PURPOSE: This study aimed to investigate the effects of Yoga Nidra and Music Therapy on sleep quality, mental health and overall well-being among recently recovered, h…

Continuation of First-Line Systemic Therapy with Progression-Directed Radiotherapy in Patients with Oligoprogressive Hepatocellular Carcinoma: A Multicenter, Single-Arm, Phase II Trial.

PURPOSE: Evidence for radiotherapy (RT) in oligoprogressive hepatocellular carcinoma (OP-HCC) is limited. We evaluated the efficacy and safety of progression-directed RT (PDRT) alongside ongoing first-line systemic therapy (FLST) in patients with OP-HCC. PATIENTS AND METHODS: Patients who developed OP-HCC during FLST were enrolled and received PDRT with a biologically effective dose of at least 60 Gy while continuing FLST. The primary endpoint was progression-free survival (PFS); secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), duratio

Endoanal ultrasound-measured internal anal sphincter changes after nonablative 1470-nm diode laser therapy for anal incontinence: a prospective single-arm pilot study.

BACKGROUND: Fecal incontinence (FI) is a debilitating condition that may be associated with structural abnormalities of the anal sphincter complex. Nonablative anal laser therapy has been proposed as a minimally invasive treatment option; however, its anatomical correlates remain insufficiently defined. OBJECTIVES: The objectives of this study were to evaluate endoanal ultrasound (EAUS)-detected changes in internal anal sphincter (IAS) morphology after nonablative 1470-nm diode laser therapy and to explore their association with clinical outcomes. METHODS: In this prospective single-arm pilo…

Multicentric, Randomized, Open-Label, Three-Arm Post Marketing Clinical Study of VELVERT® with Single- and Four-Layer Compression, for Venous Leg Ulcer.

BACKGROUND: Venous leg ulcers (VLUs) are chronic, slow-healing wounds related to chronic venous insufficiency, and they represent a significant clinical and economic burden. Despite compression therapy being the standard of care, healing remains suboptimal in many patients, necessitating improved wound care strategies. OBJECTIVE: To evaluate the comparative efficacy, safety, and clinical performance of VELVERT® advanced wound care dressing alone, VELVERT® combined with VELSOFT® compression bandage, and the VELFOUR® four-layer compression system in the management of VLUs. METHODS: This random

Does Thoracodorsal Pedicle Dissection Affect Upper-Extremity Lymphatic Drainage? Arm Circumference After Free Latissimus Dorsi Muscle Flap Harvest in Patients Without Axillary Lymphadenectomy.

Background: The free latissimus dorsi (LD) muscle flap remains a workhorse for large soft-tissue defects. Its pedicle, however, must be followed proximally into the axilla-into the immediate vicinity of the lymphatics that drain the arm-and whether this compromises upper-extremity drainage has never been settled. The few studies that examined lymphoedema after LD surgery relied on questionnaires and were confined to breast reconstruction, where axillary clearance and irradiation offer a sufficient explanation for anything they found; the harvest itself has never been isolated. Methods: We iden…

Endovenous laser ablation versus ligation plus stripping or sclerotherapy for primary lower limb varicose veins: a multicentric three-arm propensity score matched analysis.

BACKGROUND AND AIM: Varicose veins (VVs) are one of the most common consequences of chronic venous disease. The present multicentric three-arm study aimed to compare the clinical outcomes of endovenous laser ablation (EVLA) versus ligation plus stripping or sclerotherapy for primary lower limb VVs. PATIENT AND METHODS: The study included 300 patients with VVs. They received EVLA (GI, n = 100), ligation plus stripping (GII, n = 100) or ligation plus sclerotherapy (GIII, n = 100). Groups were matched using propensity score. The primary outcome measures were 1-year total occlusion and recurrence…

Efficacy and safety of fecal microbiota transplantation for chronic constipation: a systematic review and meta-analysis integrating pre-post and single-arm evidence.

BACKGROUND: Chronic constipation is a common functional gastrointestinal disorder with a global prevalence of 12%-17%. Conventional treatments have limited efficacy for refractory cases, with high recurrence and side effects. Fecal microbiota transplantation (FMT) offers a novel strategy by restoring gut microecological balance, yet its efficacy requires systematic evaluation. This meta-analysis evaluated FMT efficacy and safety through an innovative "three-in-one" framework. METHODS: We systematically searched CENTRAL, PubMed, Embase, and CNKI for RCTs, single-arm studies, and cohort studies…

Immediate effects of pain neuroscience education in physiotherapy students with chronic non-specific low back pain: a single arm pre-post intervention study.

BACKGROUND: Our study aimed to investigate the immediate effects of a single session of Pain Neuroscience Education (PNE) on pain intensity, pain knowledge, pain catastrophizing, and kinesiophobia in undergraduate physiotherapy students with chronic non-specific low back pain (CNSLBP). METHODS: This prospective, single-arm, pre-post intervention study was conducted with 79 undergraduate physiotherapy students with CNSLBP. Participants received a single, 70-minute PNE session, administered by an expert physiotherapist with a PNE certification. Before and immediately after the intervention measu…

Clinical Outcomes of Ankaferd Hemostat Mouthwash for High-Grade Oral Mucositis During Systemic Anticancer Therapy: A Single-Center, Retrospective, Single-Arm Cohort Study.

Background/Objectives: Oral mucositis (OM) is a serious toxicity that develops due to cancer treatment and impairs patients' quality of life. Ankaferd Hemostat (AH), a phytotherapeutic agent, has anti-inflammatory and tissue-healing properties. This study evaluated the clinical outcomes and safety of topical AH in adult patients with solid tumors who developed grade 3 or 4 OM during systemic anticancer therapy. Methods: A single-center retrospective, single-arm study was conducted between 2020 and 2024 and included 43 patients with solid tumors. They developed OM while undergoing systemic canc…

GPT-Powered Chatbot-Based Positive Psychology Intervention for Well-Being Among Parents of Children With Autism Spectrum Disorder: Single-Arm Mixed Methods Study.

BACKGROUND: Parents of autistic children frequently experience elevated stress levels, depressive symptoms, and reduced well-being. Positive … well-being, depression, stress, and health-related quality of life. METHODS: We conducted a single-arm mixed-methods pilot study with 19 parents with autistic children. These parents engaged with Allie for 2 weeks to complete 8 structured PPI exercises. The primary outcomes were feasibility (completion, ease of use, and practicality) and acceptabilit …

Inotuzumab ozogamicin in paediatric very high risk first B-cell acute lymphoblastic leukaemia relapse (ITCC-059): a multicentre, single-arm, phase 2 trial.

BACKGROUND: Children with very high-risk first relapse of B-cell acute lymphoblastic leukaemia have very poor outcomes with conventional chemotherapy. Inotuzumab ozogamicin has shown high antitumoral activity in second or higher relapsed or refractory B-cell acute lymphoblastic leukaemia. We aimed to evaluate the preliminary activity of inotuzumab ozogamicin single-agent in children with very high risk first B-cell acute lymphoblastic leukaemia relapse. METHODS: ITCC-059 was a multicentre, international, single-arm, phase 1-2 trial, designed to identify the recommended dose of inotuzumab ozog…

Surgical management of sickle cell retinopathy: a systematic review of clinical outcomes and a single-arm meta-analysis of single-surgery anatomical success.

INTRODUCTION: Sickle cell retinopathy is a consequence of sickle cell disease that results from vascular complications. Sickle cell disease … pathy who underwent surgery and reported anatomical and/or visual outcomes. A random effects single-arm meta-analysis was carried out in the anatomical success group using JASP software, and the risk of bias was evaluated using JBI and RoB2 tools. RESULTS: 7 studies, comprising 408 eyes, were included. Overall, the evidence showed that surgical treat …

Neoadjuvant chemoradiotherapy plus sintilimab in proficient mismatch repair locally advanced rectal cancer with intermediate/high-immunoscore (SILAR): a single-arm phase II trial.

There is an urgent need to identify those who may benefit from immunotherapy-based chemoradiotherapy (CRT) for patients with locally advanced rectal cancer (LARC) with proficient mismatch repair (pMMR). This single-arm, phase-II trial (NCT05450029), enrolled 46 treatment-naïve patients with histologically confirmed T3-4N0M0 or T1-4N+M0 LARC with intermediate or high Immunoscore. Patients received 6 cycles of mFOLFOX6 and long-course radiotherapy (50 Gy in 25 fractions) followed by surgery. Sintilimab was added during CRT (2nd-6th cycle). The primary endpoint, pathologic complete response (pCR)…