Prospective Clinical Study Research Articles

Functional Outcome in Posterior Cruciate Ligament Reconstruction with Posterolateral Corner Reconstruction: A Prospective Clinical Study

Functional Outcome in Posterior Cruciate Ligament Reconstruction with Posterolateral Corner Reconstruction: A Prospective Clinical Study

Effectiveness of peritoneal lavage fluid circulating tumour cells and circulating tumour DNA in the prediction of metachronous peritoneal metastasis of gastric cancer (pT4NxM0/pT1-3N+M0) after radical resection: protocol of a prospective single-centre clinical study

BackgroundGastric cancer (GC) is the fourth leading cause of cancer mortality worldwide. Peritoneal metastasis (PM) is a significant cause of death in patients with GC, and presents a major challenge...

Effect of orthodontic space closure on dental pulp sensitivity. Prospective clinical trial.

Orthodontic tooth movement (OTM) is a biological process that can influence the function of the pulp, including its innervation. The excitability of the nerve fibres of the pulp may be altered by forces exerted on the nerve fibres or by reduced blood flow to the pulp. The aim of this clinical study was to evaluate the sensitivity of the dental pulp during levelling and during the phase of space closure, to assess the role of certain controlled risk factors. Twenty-two adolescent participants requiring orthodontic space closure in transcanine sector were enrolled in a prospective clinical study. Patients were observed before OTM, after levelling and 1 month during active space closure. The sensitivity threshold of the pulp was measured using the electric pulp test (EPT). Dental models were obtained using an intraoral scanner, allowing measurement of interdental distances and calculation of OTM speed. The teeth were categorized according to position and tooth type. The EPT values increased significantly during orthodontic treatment (one-way RM-ANOVA, P = .014). There was a significant difference in EPT values between the tooth categories. Teeth with a single root adjacent to the residual space had the highest EPT thresholds (two-way RM-ANOVA, P < .001; Holm-Sidak, P < .05). OTM reduced pulpal sensitivity. Pulpal sensitivity during active space closure was similar to sensitivity during the levelling phase. The pulpal sensitivity of molars was less affected by OTM than that of single-rooted teeth, while teeth closer to the gap had a significantly higher pulpal sensitivity threshold during active OTM.

Impact of prosthodontic rehabilitation on psychological status and quality of life in maxillectomy patients of coronavirus disease 2019-associated mucormycosis at a tertiary care center: A prospective clinical study

Aims: The study was aimed to evaluate the effect of prosthodontic rehabilitation on psychological status (PS) and quality of life (QoL) in maxillectomy patients of coronavirus disease 2019-associated mucormycosis (CAM). Settings and Design: The study was designed as a prospective and clinical study. Materials and Methods: Twenty-four CAM patients undergoing maxillectomy and subsequent prosthetic rehabilitation were included. The treatment involved surgical, intermediate, and definitive obturator delivery at various phases of healing. PS was assessed using the Hospital Anxiety and Depression Scale (HADS), QOL using the European Organization for Research and Treatment of Cancer QoL Questionnaire-Head and Neck Module (EORTC QLQ-HandN35), and the functioning of obturator was assessed utilising the Obturator Functioning Scale (OFS) at various time points: before maxillectomy (T1), 2 weeks after maxillectomy (T2), 2 weeks upon usage of intermediate obturator (T3), just before delivery of definitive obturator (T4), and 12 weeks after the usage of definitive obturator (T5). Statistical Analysis Used: Data were analyzed using a social science statistical analysis program (Stata 14.0; StataCorp LLC, Texas, USA). The significance level was chosen &lt;0.05. Shapiro–Wilk test was used to assess the normality of quantitative data. Student’s t-test was employed (α =0.05) to evaluate if the patient’s PS, QOL, and obturator function had changed over time. The Spearman correlation coefficient (α =0.05) was utilized to evaluate the correlation coefficient between PS, QOL, and obturator function seen at T3 and T5. Results: Out of 24 enrolled patients, nine were dropped out. HADS-anxiety score was the highest at T1 (18.6 ± 1.2) and HADS-depression score was the highest at T2 (18.8 ± 1.6). HADS scores decreased significantly (P = 0.001) after prosthetic rehabilitation. EORTC QLQ-HandN35 score was the highest at T2 (105.8 ± 29.5), with statistical significance (P = 0.001) after rehabilitation. OFS was the highest at T3 (51.9 ± 3.9) and lowest at T5 (25.4 ± 2.8). Conclusion: CAM and maxillectomy deliberately affects the PS and QOL. Prosthetic rehabilitation, psychological motivation, and education create greater improvement in PS and QOL. The progress in parameters showed an upward trend with good obturator quality over a period of time.

The Value of Liver Biopsy and Histology in Liver Disease Diagnosis and Patient Care-a Pragmatic Prospective Clinical Practice Study.

We aimed to examine the correlation of pre-biopsy clinical diagnosis with hepatic histopathology. Liver biopsy provides histologic information and informs physicians about the underlying clinical disease. We hypothesized that expert physicians' pre-biopsy clinical diagnoses may obviate the need for histopathological diagnosis. Patients undergoing liver biopsy to investigate a liver diagnosis were prospectively identified. In the 80 patients included, an anonymous validated questionnaire inquiring about the most likely clinical diagnosis and liver disease stage was completed prospectively by hepatologists before biopsy performance. The most common pre-biopsy diagnoses were alcoholic liver disease (19 diagnoses), followed by non-alcoholic steatohepatitis and autoimmune hepatitis (18 each). Overall, the predicted histologic diagnosis was the same as the histologic diagnosis in 51/80 patients (64%), and thus a new liver disease diagnosis was made in 36% of patients. The diagnosis with the greatest pre-biopsy and post-biopsy diagnosis discrepancy was autoimmune hepatitis, with the correct diagnosis being predicted in 6/18 (33%) of patients (other diagnoses included the following: non-alcoholic steatohepatitis/non-alcoholic fatty liver disease (4), alcoholic liver disease (3), drug-induced liver injury (3), others (2)). For fibrosis staging, when grouped as no fibrosis (F0), fibrosis (F1-F3), or cirrhosis (F4), the fibrosis stage was correctly predicted in 68% of patients (54/80). Notably, 7 patients (9%) who were initially thought to have no or early-stage fibrosis had F4 fibrosis, and 6/80 (8%) patients who were considered to have a liver disease diagnosis before their biopsy had normal histology. Although hepatology experts often predict the correct underlying liver disease diagnosis, histopathological diagnoses different from expected are common.

Study of postoperative changes in ocular alignment in surgically corrected esotropia

Background Esotropia (ET) represents an ocular alignment disorder characterized by the eyes’ inward deviation. Aim This work aimed to compare changes in postoperative ocular alignment at 6 weeks as well as 6 months following the surgical procedure among cases, who were initially surgically adequately corrected for ET, and to determine if preoperative characteristics are correlated with these changes in ocular alignment. Patients and methods Our prospective clinical trial study involved 30 patients aged between 1 and 40 years, who developed comitant ET and had not undergone any strabismus surgery before. Results A positive weak association (r=0.406) was documented between the age of ET onset and the 6th month postoperative alignment. The age of onset of ET in both groups (infantile and partially accommodative ET) showed a significant difference (P=0.001). The differences in alignment between 1st week and 6th week and between 1st week and 6th month were significant (P&lt;0.001). Mean change in alignment at 6th week postoperatively was significantly different between amblyopic cases and nonamblyopic cases (P=0.012). The age of onset of ET and the degree of preoperative ET less than 50 prism diopters (PD) showed a significant difference between the successful versus unsuccessful cases at the 6th month postoperative (P=0.002 and 0.031, respectively). Conclusion The higher age of ET onset (nearly above 2.5 years) and the lower preoperative angle of deviation (below 40 prism diopter) are associated with a slightly better surgical outcome at the 6th month postoperatively.

The role of pulmonary rehabilitation in improving lung functions in patients with ankylosing spondylitis

Background Ankylosing spondylitis (AS) is a chronic inflammatory disease characterized by axial and peripheral entheseal inflammation and new bone production(1). The development of syndesmophytes, enthesophytes, and spinal fusion along the course of the disease is linked to chronic pain, functional impairment, and disability(2). Fibrosis of the upper lobes of the lungs (interstitial lung disease) and chest wall abnormalities are two of the emerging forms of pulmonary involvement in AS. (3). Pulmonary rehabilitation is a multifaceted program of education, counselling, breathing exercises, and other modalities that can increase the patient’s independence and ease of functioning(4). Aim To estimate the role of pulmonary rehabilitation in enhancing lung function in AS individuals in relation to disease activity, clinical, and functional parameters. Patients and methods This study was an interventional study: single-arm group (prospective randomized clinical study). Thirty people (30) participated in that study from those presented to Physical Medicine, Rheumatology and Rehabilitation inpatient and outpatient clinic at Ain Shams University hospitals, diagnosed as radiographic axial spondyloarthropathy (SPA) from 02/2022 to 12/2022. All patients underwent pulmonary rehabilitation program and were exposed to a detailed history, clinical, and pulmonary function testing. Disease activity was evaluated by Ankylosing Spondylitis Disease Activity Score C-reactive protein (ASDAS-CRP), Valuation of function by using Bath Ankylosing Spondylitis Functional index (BASFI), 6-Minute walk test (6MWT), the Modified Borg Dyspnoea Scale (MBS), and Timed Up and Go (TUG) test. All function and clinical scores were done at baseline and repeated after completing pulmonary rehabilitation program. Result The mean age of patients was 36.57 ± 7.83 years (23–45 years), with a median disease duration of (5 (3–9) years). In total, there were 19 out of the studied patients with restrictive pattern. With comparison between pre- and postintervention of pulmonary rehabilitation, there was a significant statistical difference in all, disease activity (ASDAS and BASFI) and functional (MBS, TUG, and 6MWT) parameters (P &lt;0.001), except for occiput to the wall. Regarding pulmonary function tests, including forced vital capacity (FVC), expiratory volume in one second (FEV1), and peaked expiratory flow (PEF), there was a statistically significant change at baseline and at the end of exercise (P &lt;0.001). Conclusion Improved respiratory function and disease activity and overall functional activity are possible outcomes of pulmonary rehabilitation programs in combination with other rehabilitation interventions.

Long-Term Prognostic Value of Adipocytokines in Patients with Acute Coronary Syndrome: An 8-Year Clinical Prospective Cohort Study.

To elucidate the predictive values of adipocytokines in patients with acute coronary syndrome (ACS). Overall, 297 patients with ACS were consecutively enrolled in this prospective cohort study between June 2015 and July 2017 and completed follow-up with a median follow-up time of 6.5 years. For consistency, the last visit date was June 20, 2023. Serum levels of retinol-binding protein-4 (RBP4), interleukin-1β (IL-1β), monocyte chemoattractant protein 1(MCP-1), adrenomedullin (ADM), netrin 1 (NTN 1), and omentin were measured using enzyme-linked immunosorbent assay. Follow-up data were collected during clinical visits or through telephone interviews at 1, 3, 6, 12 months, and annually. The primary endpoint was defined as major adverse cardiovascular events (MACEs), including all-cause mortality, rehospitalization for percutaneous coronary intervention, and severe angina requiring rehospitalization. All biomarkers displayed a good diagnostic ability of MACEs. The Kaplan-Meier curve showed that the cumulative survival rates of high level of RBP4, IL-1β, and MCP-1 and low level of the ADM, NTN1, and omentin had lower cumulative survival rates (Log rank tests: all p<0.05). After adjustment in the Cox hazard proportional model, the results were RBP4 ≥ 6.87 ng/mL, hazard ratio (HR)=2.512, p=0.003; IL-1β≥ 58.95 pg/mL, HR=3.809, p<0.001; MCP-1 ≥ 401.75 pg/mL, HR=4.047, p<0.001; ADM≤120.01 ng/mL, HR=3.930, p=0.008; NTN1 ≤63.7 pg/mL, HR=3.345, p=0.007; omentin ≤ 4.54 ng/mL, HR=2.830, p=0.004. P-values for interaction were > 0.05 in the sex, age, and dyslipidemia subgroups. Pro-inflammation adipocytokines RBP4, IL-1β, and MCP-1 increased and anti-inflammation biomarkers ADM, NTN1, and omentin decreased were independently associated with a higher risk of MACEs in patients with ACS.

The effect of lateral tarsal strip surgery on corneal biomechanical parameters measured by Corvis ST

PurposeTo evaluate the effect of lateral tarsal strip (LTS) surgery for involutional ectropion on corneal biomechanical properties measured by the Corvis ST device. MethodsThis prospective clinical study examined 23 patients (mean age 67.7 years) undergoing LTS for involutional ectropion. Corneal biomechanics were evaluated preoperatively and at 1 month postoperatively using the Corvis ST. Deformation amplitude, applanation length, highest concavity measurements, and corneal biomechanical indices were compared before and after LTS. ResultsThe second applanation deformation amplitude was significantly reduced after LTS compared to before (0.471 vs 0.428 mm, p = 0.031) indicating improved corneal stiffness. First applanation deflection length also decreased significantly following surgery (2.342 vs 1.967 mm, p = 0.043) suggesting enhanced corneal stability. Highest concavity deformation parameters were unchanged. Corneal biomechanical index, stiffness parameter, and intraocular pressure compensatory effect showed no significant differences pre- versus post-operatively. ConclusionsLTS surgery leads to measurable improvements in select corneal biomechanical parameters, specifically applanation deformation amplitude and deflection length. This preliminary analysis reveals subtle beneficial impacts on corneal stiffness and stability after surgical correction of ectropion. LTS appears to marginally augment corneal biomechanical properties based on Corvis ST assessment.

TCT-875 A Multicenter Prospective Clinical Study on TAVI With the J-Valve THV for Native Pure Aortic Regurgitation: Five-Year Follow-Up Outcome

TCT-875 A Multicenter Prospective Clinical Study on TAVI With the J-Valve THV for Native Pure Aortic Regurgitation: Five-Year Follow-Up Outcome

Serum levels of the incretin-like peptide 26RFa are diminished in women living with obesity and diabetes and restored after sleeve gastrectomy: Results from the prospective pilot RFa-Ba-S study.

To investigate the evolution of the incretin-like peptide 26RFa in a prospective cohort of women living with obesity with or without type 2 diabetes (T2D) before and after sleeve gastrectomy (SG). In this study, a total of 61 women were divided into three groups: women living with severe obesity without T2D (WlwOB group), women living with severe obesity and T2D (WlwOB-T2D group) and lean healthy volunteers (control group). Serum 26RFa concentrations were measured using a 26RFa enzyme-linked immunosorbent assay developed specifically for this study during meal tests before SG, and 30 and 180 days after SG. At baseline, serum 26RFa levels were reduced in the WlwOB (P < .05) and WlwOB-T2D (P < .01) groups compared with controls. In the WlwOB-T2D group, fasting 26RFa levels were found to increase throughout the entire follow-up period up to 6 months after the SG (P < .001). During the meal tests, serum 26RFa levels increased, especially in the WlwOB-T2D group at baseline. At the end of the follow-up, the profile of 26RFa concentrations obtained during the meal test in patients with severe obesity and T2D was similar to that of the controls. This prospective clinical study provides the first evidence that circulating 26RFa is altered mainly in WlwOB-T2D, and that these defects are partially reversed after SG.

Prospective Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of ACTLINK Plasma Treatment for Promoting Osseointegration and Bone Regeneration in Dental Implants.

Recent studies have explored surface treatments, such as increasing the hydrophilicity of implant fixtures, to enhance the osseointegration of implants. This prospective clinical study aimed to assess the clinical stability and efficacy of plasma treatment applied to implants with sandblast-acid etching (SLA) surfaces before placement. Twenty-eight patients requiring implant placement provided consent and were assigned randomly to either the SLA group without plasma treatment or the SLA/plasma group with plasma treatment. Recall checks were conducted one and three months after the first-stage surgery, followed by a second surgery at four months. Although no significant differences in buccal bone defects or implant stability were observed between the groups, the SLA/plasma group showed significant increases in marginal bone changes on the mesial and distal sides, as assessed using periapical radiographs. This study underscores the potential of pre-implantation plasma treatment to enhance bone regeneration around implants.

Efficacy of a Single Injection of Stromal Vascular Fraction in Dogs with Elbow Osteoarthritis: A Clinical Prospective Study

This study aimed to assess the efficacy of a single intra-articular injection of autologous stromal vascular fraction (SVF) in dogs with chronic lameness due to advanced elbow osteoarthritis (OA) that were unresponsive to conventional drug therapy. In this clinical, prospective, non-blinded, single-center study, twenty-three dogs received autologous SVF derived from falciform adipose tissue. Primary outcome measures over the six-month study period included clinical-orthopedic and radiographic examinations, objective gait analysis and validated owner questionnaires. In 19 of 23 joints, no progression of OA was visible radiographically. Peak vertical force improved significantly at three months and vertical impulse at six months after the injection compared to baseline. Over 33% of dogs demonstrated treatment-related improvements in lameness based on objective gait analysis. Owner questionnaires indicated significant improvement in clinical signs throughout the study period and 26% of dogs showed treatment-related improvements in pain scores according to the Canine Brief Pain Inventory. No side effects were reported. These findings suggest that autologous regenerative cell therapy may provide a promising treatment option for dogs with advanced OA that do not respond to conventional drug therapy. However, the treatment did not improve the clinical symptoms in all dogs, so it cannot be recommended for all patients.

Upper, middle, and lower CALYX accesses for prone percutaneous nephrolithotomy: a comparative study.

To compare upper, middle and lower calyceal accesses for prone percutaneous nephrolithotomy regarding stone-free rates, residual stones, haemoglobin drop and fluoroscopic time. The prospective comparative clinical study was conducted from September 2018 to March 2021 at Al- Yarmouk Teaching Hospital, Baghdad, Iraq, and comprised patients of either gender aged 18-78 years with renal stones treated with percutaneous nephrolithotomy. They were divided into three groups on the basis of calyx access: upper calyx G1, mid-calyx G2, and lower calyx G3. Procedure-related parameters, such as fluoroscopic time, stone-free rates and haemoglobin drop, were analysed in detail. Patients were followed up within 1-week postsurgery through complete blood count, ultrasound and computerised tomography. Data was analysed using SPSS 27. Of the 151 patients with a mean age of 46.01±14.7 years, 89(58.9%) were males and 62(41.1%) were females. There were 63(41.7%) patients in G1, 38(25.2%) in G3 and 50(33.1%) in G3. The diameter of renal stones ranged from 20-60mm. There were 45(71.4%) patients with stone-free outcome in G1, 22(57.9%) in G2 and 37(74%) in G3 (p>0.05). There was no significant difference in the mean haemoglobin drop among the groups (p>0.05). No significant intergroup difference was observed in terms of access in the sequelae regarding residual stone and haemoglobin drop.

Плацебо-контролируемое клиническое исследование эффективности D-маннозы Суперкомплекс в профилактике рецидивов ИМП.

Introduction. In recent years, the use of D-mannose as an alternative to antimicrobial agents has been widely discussed in the literature due to the fact that when applied topically, it reduces the ability of E. coli to bind to the urothelium. The aim of this study was to evaluate the change in the number of relapses during the observation period in patients who used «D-Mannose Supercomplex» as a metaphylaxis of cystitis in comparison with the control group, which received a placebo instead of this product. Materials and methods. A multicenter, randomized, double-blind, placebo-controlled, prospective clinical study was conducted to evaluate the efficacy and safety of a dietary supplement containing 2000 mg of D-mannose, 100 mg of cranberry extract, 80 mg of bearberry extract (8 mg of arbutin), and 30 mg of magnesium. Results. In animal models, the use of D-mannose led to a significant decrease in the bacterial load. The use of «D-Mannose Supercomplex» prolongs the relapse-free period in patients with RUTI after the end of antibacterial therapy. The duration of the relapse-free period correlates with the duration of D-mannose intake, which is consistent with modern concepts of the mechanism of action of the drug. The drug is well tolerated by patients. The number of adverse events (AE) in the «D-Mannose Supercomplex» and placebo groups was comparable. AE and allergic reactions associated, according to the researchers, with the use of the study drug, were not registered during the administration of the drug. Conclusions. The presented study data indicate that complex drugs containing D-mannose, cranberry extract, bearberry and magnesium (for example, «D-Mannose Supercomplex») can be considered from the standpoint of evidence-based medicine as a promising means of complex etiopathogenetic therapy for prolonging the relapse-free period in patients with exacerbation of recurrent urinary tract infection (RUTI).

Radiograph accelerated detection and identification of cancer in the lung (RADICAL): a mixed methods study to assess the clinical effectiveness and acceptability of Qure.ai artificial intelligence software to prioritise chest X-ray (CXR) interpretation

IntroductionDiagnosing and treating lung cancer in early stages is essential for survival outcomes. The chest X-ray (CXR) remains the primary screening tool to identify lung cancers in the UK; however,...

Detection of hypertension using a target spectral camera: a prospective clinical study

Hypertension is a significant contributor to premature mortality, and the regular monitoring of blood pressure (BP) enables the early detection of hypertension and cardiovascular disease. There is an urgent need for the development of highly accurate cuffless BP devices. We examined BP measurements based on a target spectral camera’s recordings and evaluated their accuracy. Images of 215 adults’ palms and faces were recorded, and BP was measured. The camera captured RGB wavelength data at 640 × 480 pixels and 150 frames per second (fps). These recordings were analyzed to extract pulse transit time (PTT) values between the face and palm, a key parameter for estimating BP. Continuous BP measurements were taken using a CNAPmonitor500 for validation. Three frequency wavelengths were measured from video images. A machine learning model was constructed to determine hypertension, defined as a systolic BP of 130 mmHg or higher or a diastolic BP of 80 mmHg or higher, using the visualized data. The discrimination between hypertension and normal BP was 95.0% accurate within 30 s and 90.3% within 5 s, based on the captured images. The results of heartbeat-by-heartbeat analyses can be used to determine hypertension based on only one second of camera footage or one heartbeat. The data extracted from a video recorded by a target spectral camera enabled accurate hypertension diagnoses, suggesting the potential for simplified BP monitoring.

Pregnancy-Associated Plasma Protein-A and Free β-Human Chorionic Gonadotrophin in Relation with Oxidative Stress in Obese Pregnant Women: A Clinical Cross-Sectional Study.

Background: The pathophysiological mechanism underlying pregnancy complications is not entirely known. Although it is currently impossible to predict the occurrence of redox imbalance, it is possible to identify women with a high or medium risk of developing this disease prior to a negative outcome by non-invasive diagnostic methods. The Aim: This study aimed to examine the possible role of the parameter of oxidative stress (OS) measured in early pregnancy in the screening/treatment of obesity and its complications during pregnancy. Methods: This research was designed as a prospective observational cross-sectional clinical study which included 40 non-obese and 31 obese pregnant women between 11 and 13 g.w. who were managed in the Department of Obstetrics, University Clinical Center Kragujevac in Serbia. We collected anthropometric and clinical indicators, maternal and pregnancy factors, and measured prooxidative parameters from blood samples. Results: We observed significantly increased levels of the superoxide anion radical, hydrogen peroxide and the index of lipid peroxidation in the Obese group in comparison with the Non-Obese group and significantly decreased bioavailability of nitrites in the Obese group in comparison with the Non-Obese group. Conclusions: The determination of systemic parameters of OS in early pregnancy could be a good methodological approach in the screening/treatment of obesity during pregnancy and this approach should be followed for the screening of endothelial dysfunction in pregnancy which needs further monitoring and/or treatment.

Inetetamab combined with sirolimus and chemotherapy for the treatment of HER2‐positive metastatic breast cancer patients with abnormal activation of the PI3K/Akt/mTOR pathway after trastuzumab treatment

AbstractBackgroundWe explored the efficacy and safety of inetetamab combined with sirolimus and chemotherapy for the treatment of human epidermal factor receptor 2 (HER2)‐positive metastatic breast cancer patients with abnormal activation of the PI3K/Akt/mTOR (PAM) pathway after trastuzumab treatment.MethodsFor this prospective multicenter clinical study, HER2‐positive metastatic breast cancer patients with PAM pathway mutations confirmed by histology or peripheral blood genetic testing were enrolled from July 2021 to September 2022. Patients were randomly assigned to a trial or control group. The patients in the trial group received inetetamab combined with sirolimus and chemotherapy, while the control group patients received pyrotinib and chemotherapy. The RECIST v1.1 standard was used to evaluate efficacy. Descriptive statistics were used to summarize the clinicopathological features, and the Kaplan–Meier method was used to generate survival curves. The log‐rank test was used to compare progression‐free survival (PFS) between the two groups.ResultsA total of 59 HER2‐positive metastatic breast cancer patients with abnormal activation of the PAM pathway were included, of which 37 received inetetamab combined with sirolimus and chemotherapy treatment and 22 received pyrotinib and chemotherapy treatment. The median PFS was 4.64 months in the inetetamab group and 5.69 months in the pyrotinib group, with no statistically significant difference (p = 0.507). The objective response rates were 27.3% for the inetetamab group and 29.4% for the pyrotinib group. The safety assessment indicated that the adverse event (AE) incidences were 86.1% (31/36) in the inetetamab group and 78.9 (15/19) in the pyrotinib group, with 9 (25%) and four (21.1%) Grade 3/4 AEs in the inetetamab and pyrotinib groups, respectively.ConclusionsFor metastatic HER2‐positive breast cancer patients with abnormal PAM pathway activation and previous trastuzumab treatment, the combination of inetetamab with sirolimus and chemotherapy is equivalent to the combination of pyrotinib and chemotherapy. Therefore, this regimen could be a treatment option for PAM pathway‐activated metastatic HER2‐positive breast cancer patients.

Similar short-term outcomes of ultrasound guided posterior intra-articular and anterior extra-articular corticosteroid injection in the treatment of primary frozen shoulder. A randomized controlled, single-blind study.

Frozen shoulder, a condition characterized by the limitation of active and passive shoulder movements, is predominantly managed conservatively. Corticosteroid injection stands as a widely utilized and effective method for treatment. Nevertheless, the optimal approach for administering the injection remains a subject of controversy. We hypothesized that the injection of corticosteroid through anterior into the extra-articular area would yield superior results than the posterior intra-articular injection. This prospective, randomized, single-blind, and single-center clinical study aimed to compare the therapeutic effectiveness of ultrasound (USG)-guided injection techniques in patients with primary frozen shoulder. We continued the study with 54 patients who met the inclusion criteria. We evaluated patients pre-injection and at the first, third, and sixth weeks after injection. Two distinct approaches were employed: (1) Injection through the anterior extra-articular area around the coracohumeral ligament (CHL), and (2) injection through the posterior route into the glenohumeral joint. Evaluation parameters, including Visual Analog Scale (VAS) scores, active range of motion (ROM), American Shoulder and Elbow Surgeons (ASES) scores, and Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) scores, were assessed pre-injection and at the first, third, and sixth weeks post injection. No significant differences in the demographic and clinical characteristics, laboratory, or radiological findings were observed between the groups. It was observed that both groups exhibited similar and significant improvement in all measured parameters within their respective groups. Regarding pain scores, a notable decrease in VAS scores was observed in both groups (P = .000). There was no difference between the groups in terms of pre-injection VAS, QuickDASH, and ASES scores and active ROM measurements. The study concluded that there was no significant difference between ultrasound-guided injection of posterior intra-articular injection and anterior extra-articular injection concerning pain, ROM, and functional scores. Both techniques can be considered as viable options in the early stage of the disease. Level I, Therapeutic study.