Результаты поиска

Rapid ART Initiation with BIC/FTC/TAF in People Who Inject Drugs in Greece: Results from a Pilot Single-Arm Study of an Integrated Care Model.

People who inject drugs (PWIDs) remain underserved in HIV care. Evidence on rapid antiretroviral therapy (ART) for PWID is limited. We evaluated feasibility, effectiveness, safety, and patient-reported outcomes (PROs) for rapid initiation of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) supported by a peer navigation in Greece. This is a single-arm, multicenter pilot study including PWIDs (≥18 years) newly diagnosed or relinking after >3 months off ART. Participants started BIC/FTC/TAF on the same day or within 7 days and received peer navigation for 48 weeks. Co-primary endpoi…

Feasibility of a 4-week combined supervised and home-based exercise program for patients with nontuberculous mycobacterial pulmonary disease: a single-center, single-arm feasibility study.

Nontuberculous mycobacterial pulmonary disease (NTM-PD) is associated with functional decline and limited treatment options, highlighting the need for adjunctive exercise interventions. This study aimed to evaluate the feasibility, safety, and preliminary effects of a 4-week combined supervised and home-based exercise program for patients with NTM-PD. This single-arm feasibility study included 23 outpatients with NTM-PD. The intervention comprised weekly supervised sessions and daily home-based aerobic and resistance training over 4 weeks. The primary outcomes were feasibility parameters (rete…

Chemotherapy combined with regorafenib and immune checkpoint inhibitors as a first-line treatment for patients with advanced biliary tract cancer: a single arm phase II trial.

OBJECTIVE: This study aimed to investigate the efficacy, long-term prognosis and safety of combining chemotherapy with regorafenib and immune checkpoint inhibitors as first-line treatment for patients with advanced biliary tract carcinoma (BTC). METHODS: In this single arm phase II trial, twenty-nine patients with advanced BTC were included, all of whom received gemcitabine-based chemotherapy combined with regorafenib and immune checkpoint inhibitors as the first-line treatment. And the study analyzed anti-tumor efficacy, long-term prognosis, and adverse reactions. RESULTS: Among the patient…

A low molecular weight dextran sulphate, ILB®, for the treatment of amyotrophic lateral sclerosis (ALS): An open-label, single-arm, single-centre, phase II trial.

BACKGROUND: Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig´s disease, is a rare neurological condition and is the most common motor neurone disease. It is a fatal disease with specific loss of motor neurons in the spinal cord, brain stem, and motor cortex leading to progressive paralysis and usually death within five years of diagnosis. There remains no cure for ALS, and management is focused on a combination of neuroprotective medication, respiratory support, and management by multidisciplinary clinics. PATIENTS AND METHODS: This prospective, single-arm, open-label phase II cl…

[Treatment of irreducible intertrochanteric femoral fracture in elderly by folding top technique combined with right-angle pliers prying and pulling under G-arm X-ray fluoroscopy].

OBJECTIVE: To explore the effectiveness of irreducible intertrochanteric femoral fracture in the elderly by treating with folding top technique and right-angle pliers prying and pulling under G-arm X-ray fluoroscopy. METHODS: The clinical data of 74 elderly patients with irreducible intertrochanteric femoral fracture admitted between February 2016 and December 2022 and met the selection criteria were retrospectively analyzed. Among them, 38 cases were treated with folding top technique combined with right-angle pliers prying and pulling under G-arm X-ray fluoroscopy and intramedullary nailing…

A standardized Boswellia serrata extract shows improvements in knee osteoarthritis within five days-a double-blind, randomized, three-arm, parallel-group, multi-center, placebo-controlled trial.

BACKGROUND: Boswellin® Super is a standardized extract of Boswellia serrata Roxb gum resin, standardized to contain 30% 3-acetyl-11-keto-β-boswellic acid along with other β-boswellic acids (BSE). A randomized, double-blind, placebo-controlled clinical trial was conducted at two doses of BSE to understand its safety and efficacy in supporting joint health and improving mobility and symptoms of osteoarthritis (OA) of the knee. METHODS: Based on the inclusion/exclusion criteria, 105 newly diagnosed participants with degenerative hypertrophy OA were recruited and randomized into Placebo, BSE-150 

Diagnosing Allergic Contact Dermatitis Using Deep Learning: Single-Arm, Pragmatic Clinical Trial with an Observer Performance Study to Compare Artificial Intelligence Performance with Human Reader Performance.

Background: Allergic contact dermatitis is a common, pruritic, debilitating skin disease, affecting at least 20% of the population.Objective: To prospectively validate a computer vision algorithm across all Fitzpatrick skin types.Methods: Each participant was exposed to 10 allergens. The reference criterion was obtained 5 days after initial patch placement by a board-certified dermatologist. The algorithm processed photographs of the test site obtained on Day 5. Human performance in reading the photographs was also evaluated.Results: A total of 206 evaluable participants [mean age 39 years, 66

Влияние краткосрочной прогрессивной физической тренировки на активность заболевания у пациентов с подозрительной множественной миеломой и моноклональной гамма-патологией неопределенного значения: односторонний пилотный исследование.

ОБЪЕКТ: Высокий уровень физической активности связан с уменьшением риска развития крови опухоли множественной миеломы (ММ). ММ предшествует асимптоматическим стадиям моноклональной гамма-патологии неопределенного значения (MGUS) и дымящей множественной миеломы (SMM), которые клинически управляются методом наблюдения. Случайный исследователь (N = 1) бывшего высшего спортсмена в возрасте 44 лет показал, что многофакторная программа физических упражнений обратила активность SMM. С учетом результатов этого предыдущего тематического исследования в настоящем экспериментальном исследовании сначала ра

Совпадение в аннотации оригинала
BACKGROUND: High levels of physical activity are associated with reduced risk of the blood cancer multiple myeloma (MM). MM is preceded by t … ients, and secondly investigated the effects on MGUS/SMM disease activity. METHODS: In this single-arm pilot study, N = 20 participants diagnosed with MGUS or SMM were allocated to receive a 16-week progressive exercise programme. Primary outcome measures were feasibility and safety. Secondary outcomes were pre- to post-exercise training changes to b …

Reduced dose azacitidine plus venetoclax as maintenance therapy in acute myeloid leukaemia following intensive or low-intensity induction: a single-centre, single-arm, phase 2 trial.

BACKGROUND: Patients with acute myeloid leukaemia have high rates of relapse, especially if they are unable to complete standard consolidati … x as maintenance therapy in acute myeloid leukaemia. METHODS: We performed a single-centre, single-arm, phase 2 study at the University of Texas MD Anderson Cancer Center in the USA. Eligible patients were adults (aged ≥18 years) with a WHO 2016 diagnosis of acute myeloid leukaemia in complete remission or complete remission with incomplete blood cou …

Ruxolitinib in treatment-naive or corticosteroid-refractory paediatric patients with chronic graft-versus-host disease (REACH5): interim analysis of a single-arm, multicentre, phase 2 study.

BACKGROUND: Chronic graft-versus-host disease (GVHD) is a debilitating, and sometimes life threatening, complication of allogeneic haematopoietic stem-cell transplantation (HSCT). We aimed to investigate the activity, pharmacokinetics, and safety of ruxolitinib added to corticosteroids in paediatric patients (ie, <18 years) with moderate-to-severe chronic GVHD. METHODS: In this single-arm, phase 2 study, patients were recruited at 21 hospitals or clinics across 14 countries in Asia, Europe, and Canada. Eligible patients were aged 28 days to younger than 18 years, had undergone allogenic HSCT,…

The Effect of a Novel Weight-Supported Kinetic Chain Resistance Training Program on Proximal Core Muscular Endurance, Trunk-to-Arm Muscular Power, and Bat Swing Speed.

Palmer, TG, and McCabe, M. The effect of a novel weight-supported kinetic chain resistance training program on proximal core muscular endurance, trunk-to-arm muscular power, and bat swing speed. J Strength Cond Res 37(11): 2130-2140, 2023-Muscular stability and muscular power at the proximal core segments of the pelvis, spine, and trunk are essential attributes in maximizing bat swing speed in the sport of softball. Weight-supported kinetic chain resistance training (WsKC) is a novel closed kinetic chain technique that provides synergistic multiplanar stressors to the proximal core segments vi…

Efficacy of Vonoprazan vs. Pantoprazole or Non-acid Suppression in Prevention of Post-variceal Ligation Ulcer Bleeding in Portal Hypertension: A Multi-arm Randomized Controlled Trial.

BACKGROUND: Up-to-date data about the role of acid suppression therapy e.g. proton-pump inhibitors; to reduce post-endoscopic variceal ligation (EVL) ulcer-bleeding are conflicting. Vonoprazan; a recently introduced potassium-competitor acid blocker, has not been studied to prevent post-EVL ulcer/bleeding. The aim was to evaluate the efficacy of vonoprazan vs. pantoprazole or non-acid suppression to prevent post-EVL ulcer/bleeding in portal hypertension patients. MATERIAL AND METHODS: We enrolled 275 portal hypertension patients undergoing EVL in a three-arm randomized, single-blind, controll…

Sequential CD19 and CD22 chimeric antigen receptor T-cell therapy for childhood refractory or relapsed B-cell acute lymphocytic leukaemia: a single-arm, phase 2 study.

BACKGROUND: Relapses frequently occur following CD19-directed chimeric antigen receptor (CAR) T-cell treatment for relapsed or refractory B-cell acute lymphocytic leukaemia in children. We aimed to assess the activity and safety of sequential CD19-directed and CD22-directed CAR T-cell treatments. METHODS: This single-centre, single-arm, phase 2 trial, done at Beijing GoBroad Boren Hospital, Beijing, China, included patients aged 1-18 years who had relapsed or refractory B-cell acute lymphocytic leukaemia with CD19 and CD22 positivity greater than 95% and an Eastern Cooperative Oncology Group …

Case report: A choroidal fissure pial arteriovenous malformation inducing venous congestive edema of the medulla oblongata and cervicothoracic spinal cord presented with proximal arm predominant weakness.

Intracranial dural arteriovenous fistula (DAVF) can induce remote myelopathy via spinal perimedullary venous drainage. In the present study, we report a rare case of intracranial pial arteriovenous malformation (AVM)-related myelopathy. A 52-year-old man presented with progressive, predominantly proximal weakness and muscle atrophy in bilateral upper limbs, urinary retention, and hyperreflexia in bilateral upper and lower limbs. Brain and cervicothoracic MRI showed longitudinal myelopathy extending from the medulla oblongata to the T6 level, with perimedullary enlarged veins from the C1 to T12

GPRC5D CAR T cells (OriCAR-017) in patients with relapsed or refractory multiple myeloma (POLARIS): a first-in-human, single-centre, single-arm, phase 1 trial.

BACKGROUND: Chimeric antigen receptor (CAR) T-cell therapy targeting B-cell maturation antigen (BCMA) has shown activity in treating relapsed or refractory multiple myeloma; however, relapse is still common, and new targets are needed. We aimed to assess the activity and safety profile of G protein-coupled receptor class C group 5 member D (GPRC5D)-targeted CAR T cells (OriCAR-017) in patients with relapsed or refractory multiple myeloma. METHODS: POLARIS was a first-in-human, single-centre, single-arm, phase 1 trial of GPRC5D-targeted CAR T cells (OriCAR-017) done at the First Affiliated Hos…

Efficacy and Safety of a Nonanimal Stabilized Hyaluronic Acid/Dextranomer in Improving Fecal Incontinence: A Prospective, Single-Arm, Multicenter, Clinical Study With 36-Month Follow-up.

BACKGROUND: Fecal incontinence affects 7% to 12% of the US adult population, causing social, financial, and quality of life burdens. OBJECTIVE: The primary aim of this study was to evaluate the efficacy and safety of nonanimal stabilized hyaluronic acid/dextranomer through 36 months as a condition of postmarket approval application. DESIGN: This was a prospective, single-arm, multicenter, observational Food and Drug Administration-mandated postapproval clinical study. SETTINGS: This study was designed and executed by participating centers in 18 hospitals and colorectal health clinics in coo…

EnGraft: a multicentre, open-label, randomised, two-arm, superiority study protocol to assess bioavailability and practicability of Envarsus® versus Advagraf™ in liver transplant recipients.

BACKGROUND: Graft rejection and chronic CNI toxicity remain obstacles to organ transplant success. Current formulations of tacrolimus, such as Prograf® and Advagraf™, exhibit limitations in terms of pharmacokinetics and tolerability, related in part to suboptimal bioavailability. As dosing non-compliance can result in graft rejection, the once daily formulation of tacrolimus, Advagraf™, was developed (vs 2x/day Prograf®). Benefits of Advagraf™ are counterbalanced by delayed achievement of therapeutic trough levels and need for up to 50% higher doses to maintain Prograf®-equivalent troughs. Env…

Protocol to evaluate the efficacy and safety of tolvaptan in patients with refractory ascites after liver resection: an open-label, single-arm phase I/II study.

BACKGROUND: In patients with chronic liver diseases such as cirrhosis, massive ascites after hepatic resection is the cause of prolonged hospitalization and worsening prognosis. Recently, the efficacy of tolvaptan in refractory ascites has been reported; however, there are no reports on the efficacy or safety of tolvaptan for refractory ascites after hepatic resection. This study aims to evaluate the efficacy of early administration of tolvaptan in patients with refractory ascites after hepatic resection. MATERIALS AND METHODS: This is an open-label, single-arm phase I/II study. This study su…

Postoperative full leg radiographs exhibit less residual coronal varus deformity compared to intraoperative measurements in robotic arm-assisted total knee arthroplasty with the MAKO™ system.

PURPOSE: Robotic arm-assisted total knee arthroplasty (raTKA), currently a major trend in knee arthroplasty, aims to improve the accuracy of implant positioning and limb alignment. However, it is unclear whether and to what extent manual radiographic and navigation measurements with the MAKO™ system correlate. Nonetheless, a high agreement would be crucial to reliably achieve the desired limb alignment. METHODS: Thirty-six consecutive patients with osteoarthritis and a slight-to-moderate varus deformity undergoing raTKA were prospectively included in this study. Prior to surgery and at follow…