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NCT ID: NCT05466266 Not yet recruiting - Atrial Fibrillation Clinical Trials

Comparison of Peri-procedural Complications of Intracardiac Echocardiography and Transesophageal Echocardiography in Patients With Atrial Fibrillation

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is the most common arrhythmia. Worldwide, the incidence of atrial fibrillation in men and women is 596.2 per 100,000 and 373.1 per 100,000, respectively. [1] The prevalence of AF in China is 0.97%.[2] AF increases the risk of stroke, heart failure and death. Ischemic stroke occurs in 25% of hospitalized patients with nonvalvular atrial fibrillation according to a single-center clinical study in China. [3,4] Complications associated with AF place a huge burden on the healthcare system, with an estimated 4.9 billion RMB for patients with AF in China, 89% of which are caused by AF-related strokes.[5] According to the 2018 AHA/ACC/HRS guideline [6], catheter ablation was recommended for paroxysmal AF that is symptomatic and refractory or intolerable to at least one class I or III antiarrhythmic drug. Transesophageal echocardiography (TEE) is a necessary preoperative examination for catheter ablation of patients with AF in order to exclude thrombus in the left atrium and left atrial appendage (LAA) and to prevent thrombotic complications caused by thrombus shedding during the procedure. However, TEE detection, like gastroscopy, requires transpharyngeal insertion of the probe into the esophagus and should be fasted before it. The TEE probe is thicker than the gastroscope, which can increase the discomfort of the patient during the examination. At the same time, if the patient cooperates poorly during the delivery process, the probe may damage the oropharyngeal or esophageal mucosa, causing complications such as bleeding or perforation. Intracardiac echocardiography (ICE) is a new technique that can completely replace TEE in excluding thrombus in left atrium and left atrial appendage. The advantages are that the catheter is inserted from the femoral vein without the discomfort of stimulating the swallowing reflex caused by TEE examination; To avoid complications such as bleeding or perforation caused by injury to oropharynx or esophageal mucosa; It can be used in frail, elderly, pharyngeal or esophageal lesions (eg, ulcers, varices), or intolerable patients. Some studies have shown that ICE is an important test for the diagnosis of LAA thrombosis, especially when thrombus is described as a soft thrombus. TEE is the gold standard for the detection of thrombi in the LAA before catheter ablation for AF. ICE is used to assist AF ablation; however, ICE is also accurate for LAA visualization and minimizes the complications during procedures[7]. The primary purpose of this study aimed at determining whether ICE could replace TEE by minimizing the procedural-related complications but not compromise the detection of thrombi in the LAA.

NCT ID: NCT05466305 Not yet recruiting - Denture Stomatitis Clinical Trials

Assessment of Maxillary Acrylic Resin Complete Dentures Reinforced by Gold Plated Cr-Co Palatal Plate

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Gold is widely used in prosthetics. Its use ranges from being employed in the fabrication of removable dentures, where the inner surface permanently touching oral cavity tissues, through to fixed dentures, and even some structures of certain implantological systems. All such items can be made of galvanized gold. Thus, new technologies have made gold and its alloys a kind of a universal material.

NCT ID: NCT05466396 Not yet recruiting - COPD Clinical Trials

Lung Health of Early COPD: A Multi-center Cohort Study

LHEC
Start date: August 1, 2022
Phase:
Study type: Observational

This is a multi-center, prospective, cohort study in early COPD patients. This study aims to elucidate the lung function decline and its association with smoking and other risk factors. Other biomarkers and image markers from chest CT scan are also analyzed to investigate the lung function in early COPD patients.

NCT ID: NCT05466695 Not yet recruiting - Clinical trials for Erectile Dysfunction and Neutrophil Lymphocyte Ratio

Comparing The Effect of Tadalafil 5 mg/Day to Sildenafil 25 mg/Day on Neutrophil-Lymphocyte and Platelet-Lymphocyte Ratios in Erectile Dysfunction Patients; and Comparison of Clinical Response

Start date: August 1, 2022
Phase: Early Phase 1
Study type: Interventional

1- To evaluate the effect of using tadalafil 5mg/day or sildenafil 25mg/day in the treatment on these ratios and its clinical effect in erectile dysfunction patients.

NCT ID: NCT05466968 Not yet recruiting - Clinical trials for Acute Myocardial Infarction

Intervention of Suxiao Jiuxin Pill on Instability of Vulnerable Plaque in Acute Myocardial Infarction

Start date: August 1, 2022
Phase: Phase 4
Study type: Interventional

The incidence of cardiovascular disease is still high in China under the condition of non-standard treatment of Western medicine. Acute coronary plaque rupture and thrombosis is an extreme manifestation of instability of "vulnerable plaque", which is the result of the joint action of multiple factors. The intervention of unstable plaque reversal from multiple factors is inherently reasonable. Compared with the treatment of thrombosis and unstable plaque in western medicine, quick acting Jiuxin Pill can not only calm and relieve pain for pain and other symptoms, but also regulate immune inflammation and metabolic disorder, improve microcirculation and anti myocardial ischemia. In order to evaluate the efficacy, safety and modern scientific basis of Suxiao Jiuxin Pill in acute myocardial infarction (AMI), the investigators designed this study.

NCT ID: NCT05467202 Not yet recruiting - AML Clinical Trials

Evaluate the Safety and Efficacy of CLL1 CAR-T in Patients With R/R AML

Start date: August 1, 2022
Phase: Phase 1
Study type: Interventional

This is an open label, phase I study to assess the safety and efficacy of CLL1 CAR-T in patients with relapsed and refractory acute myeloid leukemia

NCT ID: NCT05468528 Not yet recruiting - Atrial Fibrillation Clinical Trials

Clinical Value of Linear Ablation Without Pulmonary Vein Isolation in Persistent Atrial Fibrillation

CLEAR AF II
Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Based on previous theoretical foundation and clinical practice experience, the investigators further propose a multi-center randomized prospective trial to compare the pure linear ablation strategy without pulmonary vein isolation to traditional PVI ablation for persistent AF. population size is 207. The participants will be randomized to the linear ablation group and PVI ablation group with a 2:1 ratio. the follow-up period is 12 months. The primary outcome is freedom from atrial fibrillation, the secondary outcome is complications related to ablation.

NCT ID: NCT05468658 Not yet recruiting - Delivery Problem Clinical Trials

The Effect of Feng Shui Delivery Room Design on Maternal and Infant Health

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The aim of the study is to compare the births that took place in the Feng Shui Birth unit and those that took place in the standard delivery unit in terms of mother-infant health outcomes. The study will be carried out in a private clinic in Istanbul, between July and December 2022. In the study, which is planned as a controlled experimental study, 50 women who applied first and met the inclusion criteria of the study will be selected as the Control Group (B), and it is planned that these women will give birth using the normal routine delivery unit of the clinic. It is planned that the next 50 women will form the Experimental Group (A): and give birth in the birth environment designed according to the Feng Shui Philosophy.

NCT ID: NCT05468762 Not yet recruiting - Clinical trials for Transfemoral tranScatheter Aortic valvE Implantation

Ultrasound arteriaL Stiffness evaluatIon and vaScular Complications in Patients Undergoing Transfemoral tranScatheter Aortic valvE Implantation: ULISSE Study.

ULISSE
Start date: August 1, 2022
Phase:
Study type: Observational

Transcatheter aortic valve implantation (TAVI) is an established treatment modality in patients ≥ 75 years old with severe symptomatic aortic stenosis after Heart Team evaluation (1). Patients with high/prohibitive surgical risk and life expectancy ≥ 1 years are candidates for TAVI according to the current guidelines (1). Nowadays is expected a progressive increase of TAVI procedures, in relationship to aging and increased life expectancy (2). Percutaneous, particularly trans-femoral, access represents the best choice in the vast majority of TAVI patients, because of its minimal invasiveness and reduced mortality, due to lower rates of periprocedural bleedings and strokes (3,4). Technical advancements, improving expertise and simplification of procedure, lead to reduction of vascular complications, still significant, and linked with worst patients' outcome (5). Some factors are considered to increase the risk of vascular complication: patient related and procedural related factors. Patient-related factors include female gender, severe vascular calcification and peripheral vascular disease. Procedural related risk factors consist of increased sheath to femoral artery ratio (SFAR) and TAVI centre experience/case load (5). Considering the last 10 years progress in techniques, devices technology and clinical outcome, a new Valve Academic Research Consortium (VARC) consensus manuscript was published to provide an update of these emerging clinical and research issues in aortic valve therapy (6). Arterial stiffness is a physiologic phenomenon occurring with age and involving changes in extracellular matrix components of the arterial wall. Particularly, the elastin fibres undergo proteolytic degradation and chemical alteration, with consequent increased production of collagen, by vascular smooth muscle cells with progressive arterial wall stiffening (7). Arterial stiffness appears to be accelerated under pathological conditions, such as hypertension, smoking, diabetes mellitus (DM) and kidney disease (8), furthermore has been shown to have two-fold higher incidence in women compared to men (9). TAVI patients have higher median age and comorbidities, directly correlated with arterial stiffness (7), and female gender is a considered high-risk feature for vascular complication independently from SFAR and atherosclerosis (5). Arterial stiffness induces progressive reduction of tensile strength, elongation and burst pressure with consequent drop of vessels breakpoint (10), that could be associated with vascular complications. Particularly, femoral artery stiffness could predispose to microlesions formation at TAVI device access, inducing vascular closure devices failure and vascular complications. Furthermore, vessel rigidity can be associated with a higher resistance during TAVI device delivery and increased probability of vessels injury (especially in presence of tortuosity and small artery diameters). Nowadays, there are no studies evaluating the relationship between arterial stiffness and TAVI vascular complications. The aim of this study is to evaluate the relationship between arterial stiffness and TAVI vascular complications, defining a new predictor of vascular complications in order to give more accurate information for procedures planning.

NCT ID: NCT05468775 Not yet recruiting - Visual Function Clinical Trials

Naked Eye 3D Vision Training for the Prevention and Control of Myopia in Adolescents and Children

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The study used children aged 6-18 as subjects to evaluate the efficacy and safety of naked eye 3D vision training for the prevention and control of myopia in adolescents. A total of 250 subjects were recruited from Zhongshan Ophthalmology Center of Sun Yat-sen University, Shenzhen People's Hospital and Foshan Women's and Children's Hospital, with 1:1 as intervention group and control group. The study assumes that daily naked eye 3D vision training can effectively control the speed of axial elongation and the progression of myopia. The main indicators were the use of optical biometrics to detect the subjects' initial axial length and the axial length after 1 month, 3 months and 6 months of intervention. Secondary indicators were refraction, uncorrected visual acuity, best corrected visual acuity, choroidal thickness, and binocular vision.