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NCT ID: NCT06255613 Not yet recruiting - Arrhythmia Clinical Trials

Validation of Belun Ring Gen3 Deep Learning Algorithms With Subxiphoid Body Sensor

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Hypothesis: BR's Gen3 DL algorithms, combined with its subxiphoid body sensor, can accurately diagnose OSA, categorize its severity, identify REM OSA and supine OSA, and detect central sleep apnea (CSA). Primary Objective: To rigorously evaluate the overall performance of the BR with Gen3 DL Algorithms and Subxiphoid Body Sensor in assessing SDB in individuals referred to the sleep labs with clinical suspicion of sleep apnea and a STOP-Bang score > 3, by comparing to the attended in-lab PSG, the gold standard. Secondary Objectives: To determine the accuracy of BR sleep stage parameters using the Gen3 DL algorithms by comparing to the in-lab PSG; To assess the accuracy of the BR arrhythmia detection algorithm; To assess the impact of CPAP on HRV (both time- and frequency-domain), delta HR, hypoxic burden, and PWADI during split night studies; To assess if any of the baseline HRV parameters (both time- and frequency-domain), delta heart rate (referred to as Delta HR), hypoxic burden, and pulse wave amplitude drop index (PWADI) or the change of these parameters may predict CPAP compliance; To evaluate the minimum duration of quality data necessary for BR to achieve OSA diagnosis; To examine the performance of OSA screening tools using OSA predictive AI models formulated by National Taiwan University Hospital (NTUH) and Northeast Ohio Medical University (NEOMED).

NCT ID: NCT06256900 Not yet recruiting - Clinical trials for Mechanical Ventilation Complication

Flow Controlled Ventilation in Robot-assisted Laparoscopic Surgery

FCV-IMPALA
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The optimization of ventilation is especially important during general anaesthesia, when active, physiologic respiration suspends and is replaced by non-physiologic mechanical positive pressure ventilation. Aiming at preserving compliance of lung tissue to guarantee an effective gas exchange is to avoid an excessive pressure application, especially in extreme positioning of the patient (Trendelenburg positioning) and/or pneumoperitoneum resulting in additional non-physiologic intrathoracic pressure. Perioperative lung protection strategies have steadily improved in recent years to reduce complications from mechanical ventilation, but postoperative pulmonary complications remain a risk factor for increased morbidity and mortality.

NCT ID: NCT06258447 Not yet recruiting - Clinical trials for Ischemic Heart Failure

CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Concentrated autologous bone marrow mononuclear cells (ABM MNC) contain potentially therapeutic cell factors and past studies support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure when utilized as this study is designed. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization.

NCT ID: NCT06258785 Not yet recruiting - Clinical trials for Postoperative Urinary Retention

Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension

Start date: April 1, 2024
Phase: Phase 3
Study type: Interventional

Postoperative urinary retention has been defined as the inability to void despite having fluid in the bladder during the postoperative period. Urinary retention after pelvic reconstructive surgery requiring indwelling catheter or self-catheterization usage occurs in approximately 30-60% of patients postoperatively. Our prior retrospective chart review reviewing postoperative urinary retention rates after pelvic reconstructive surgery demonstrated postoperative urinary retention after a sacrospinous vaginal vault suspension to be approximately 78.9%. Many women consider being discharged home with a Foley catheter to be a surgical complication and describe catheter use as the worst aspect of their surgery. Indwelling catheters are the leading cause of hospital-acquired urinary tract infections (UTIs), are often a source of embarrassment and inconvenience for patients, and often require additional office visits and healthcare utilization. Tizanidine is a muscle relaxant which can work to alleviate this spasm and, theoretically, prevent postoperative urinary retention. Tizanidine also works as an alpha-adrenergic receptor blocker which can increase smooth muscle relaxation around the urethra specifically and, theoretically, improve urine flow. Postoperative urinary retention is extremely common after pelvic reconstructive surgery involving a sacrospinous vaginal vault suspension and is extremely bothersome to patients. Tizanidine is a low-risk, well tolerated, cost-effective medication. No study to date has evaluated preoperative administration of tizanidine for postoperative urinary retention.

NCT ID: NCT06258954 Not yet recruiting - Cancer of Lung Clinical Trials

Effect of 3D-printed Reconstruction System in Size of Left DLT

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The precise and accurate size of DLT is a prerequisite to ensure its accurate position of its placement. Three-dimensional (3D) reconstruction technology can accurately reproduce the tracheobronchial structure to improve the correct size selection of DLT. To make it simpler, the investigators developed an automatic comparison software for 3D reconstruction based on computed tomography data (3DRACS). In this study, the investigators aimed to prove that 3DRACS is much more efficient in endobronchial intubation compared to the traditional method.

NCT ID: NCT06259058 Not yet recruiting - Pancreatic Cancer Clinical Trials

Stereotactic Body Radiation Therapy Followed by NALIRIFOX vs NALIRIFOX for Borderline Resectable Pancreatic Cancer

Start date: April 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This multicentric open-label trial will compare the efficacy and safety of stereotactic body radiation therapy (SBRT) followed by NALIRIFOX (5-fluorouracil, leucovorin, irinotecan liposome injection and oxaliplatin) vs NALIRIFOX for borderline resectable pancreatic cancer (BRPC).

NCT ID: NCT06259929 Not yet recruiting - Breast Cancer Clinical Trials

NEOadjuvant Abemaciclib and GIredestrant triaL in Patients With ER-positive, HER2-negative Early Breast Cancer

Neo-AGILE
Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

The objective of the study is to evaluate the efficacy and the safety of abemaciclib and giredestrant before surgery in participants with early stage, oestrogen receptor-positive (ER+), human epidermal receptor 2 negative (HER2-) breast cancer (BC). Primary objective: ● To evaluate the efficacy of abemaciclib and giredestrant in complete cell cycle arrest (CCCA) rate at Week 2. Secondary objectives: - To evaluate the efficacy of abemaciclib and giredestrant in reducing the relative Ki67 expression from baseline to Week 2 - To evaluate the efficacy of abemaciclib and giredestrant in risk of recurrence (ROR) score reduction, clinical and radiological tumor response; - To evaluate the safety of abemaciclib and giredestrant. Exploratory objectives: - To evaluate the mechanisms of response and resistance to therapy; - To evaluate the correlation between Ki-67% reduction and 18- Fluorothymidine (FLT) uptake reduction; - To evaluate the pathological complete response (pCR) rate (ypT0/is, ypN0) of giredestrant plus abemaciclib

NCT ID: NCT06259968 Not yet recruiting - Clinical trials for Anterior Cruciate Ligament Reconstruction

Neuromuscular Electrical Stimulation Superimposed or Not on Voluntary Contraction After Reconstruction of the Anterior Cruciate Ligament: a Randomized Controlled Trial

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

This study aims to evaluate the effectiveness of neuromuscular electrical stimulation with superimposed voluntary contraction (NMES+ group) compared to NMES without voluntary contraction (NMES group) during the initial month of rehabilitation post anterior cruciate ligament reconstruction (ACLR). Forty patients will be randomly assigned to either the NMES group or the NMES+ group. Both groups will follow an identical rehabilitation regimen in the first month after surgery, which includes interventions for symptom management, inflammation control, edema reduction, improved joint motion range, and restoration of muscle function. All participants will undergo identical assessment protocols at four time points: pre-surgery evaluation, and assessments at 2, 15, and 30 days post-ACLR. The primary outcome of the study is the maximal isometric strength of knee extensors. Secondary outcomes encompass thigh muscle atrophy, self-reported functional impairments, knee pain, knee edema, joint range of motion, and quadriceps activation status.

NCT ID: NCT06263205 Not yet recruiting - Pain, Postoperative Clinical Trials

Wound Management Following Gl Tumor Surgery: Comparing Outcomes of Dressing Changes Versus Non-Dressing Techniques

Dressing
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assess the effectiveness and safety of non-dressing (exposed wound) versus dressing techniques in postoperative wound management for patients with gastrointestinal tumors. The main questions it aims to answer are: 1. Does non-dressing of postoperative wounds in gastrointestinal tumor surgery provide equivalent or better wound healing compared to traditional dressing techniques? 2. Can non-dressing of postoperative wounds reduce patient pain and healthcare costs? Participants in this study, who are diagnosed with gastrointestinal tumors and undergoing surgery, will be randomly assigned to either the non-dressing group or the dressing group. The non-dressing group will have their surgical wounds left exposed after initial postoperative care, while the dressing group will receive regular wound dressing changes every 48-72 hours. Researchers will compare these two groups to see if there are differences in the rate of wound complications, pain levels, and overall healthcare costs. This study aims to provide evidence-based recommendations for postoperative wound care in gastrointestinal tumor surgeries, potentially improving patient outcomes and reducing medical expenses.

NCT ID: NCT06263244 Not yet recruiting - Inflammation Clinical Trials

Specifying the Anti-inflammatory Effects of Ziltivekimab

SPIDER
Start date: April 1, 2024
Phase: Phase 3
Study type: Interventional

The goal of this randomized, double blind, placebo controlled trial is to study whether ziltivekimab therapy reduces arterial wall inflammation as assessed by imaging, and reduces the systemic inflammatory tone as assessed by circulating monocytes, inflammatory biomarkers and proteomics.