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NCT ID: NCT05914857 Not yet recruiting - Clinical trials for Impaired Glucose Tolerance

Evaluation of the Safety and Efficacy of SGLT2 Inhibitors in Pre-diabetic Patients

Start date: December 20, 2023
Phase: Phase 2
Study type: Interventional

Pre-diabetes is a state characterized by subclinical impairment in glycemic variables that is intermediate between normal glucose tolerance (NGT) and diabetes. There are two frequently used definitions for pre-diabetes, one from the American Diabetes Association (ADA) and another from the World Health Organization (WHO), and both include impaired glucose tolerance (IGT), impaired fasting glucose (IFG), and a calibrated hemoglobin A1c (HbA1c) of between 5.7 and 6.4%. More than 30 % of the global population demonstrated one or more forms of prediabetic dysglycaemia. In general, approximately 70 % of individuals with IFG and/or IGT can expect to go on to develop clinical type 2 diabetes at some time in the future, and the risk increases with higher HbA1c levels and with higher BMI. Worse still, the prevalence of pre-diabetes is increasing worldwide, with a growing number of patients progressing to diabetes. Identification and treatment of pre-diabetic individuals is therefore crucial. Recent evidence suggested that preventing progression of pre-diabetes to diabetes is possible, and thus efficacious interventions for pre-diabetic individuals are the cornerstone of diabetes prevention. The current paradigm for diabetes prevention in high-risk individuals focuses on achieving moderate weight loss via dietary change and increasing physical activity. However, lifestyle-based weight-loss strategies may initially be successful, but difficult to achieve or maintain. In many cases, pharmacologic treatments may be needed to regulate blood glucose. Randomized clinical trials (RCTs) have verified the efficacy of metformin in preventing insulin resistance syndrome, along with the progression of microvascular diseases and heart attacks. Meanwhile, clinical experience and trial data have yielded almost no significant safety concerns for metformin. Nonetheless, it may cause discomfort for up to 25% of patients who experience diarrhea and nausea subsequent to its administration. For patients with a contraindication or intolerable adverse effects to metformin, Sodium Glucose Cotransporter 2 (SGLT-2) inhibitors with novel mode of action may be another alternative. Large clinical trials have not yet identified a substantial elevation in the frequency of adverse reactions related to SGLT-2 inhibitors when compared to the placebo group. Inhibition of SGLT-2 has some extra advantages for diabetes management over other therapeutic approaches. Firstly, the SGLT-2 is exclusively expressed in renal proximal tubules, and thus selective inhibitors will exert a glucose-lowering effect, independently of insulin secretion. Therefore, SGLT-2 inhibitors can cause weight loss without inducing major hypoglycemic events. Secondly, the cardiovascular benefits of SGLT-2 inhibitors was supported by large clinical trials in the modern context of antiplatelet, statin, and blood pressure management, which may match many of the advantages of metformin. Thirdly, SGLT-2 inhibitors have also been proven to prevent nephropathy for its restriction on albuminuria and inflammatory processes, and to subsequently dampen the deterioration in renal function. Overall, SGLT-2 inhibitors have demonstrated safety in non-diabetic patients, particularly in those afflicted with heart or kidney failure, and have shown to provide additional benefits. At present, the overall effectiveness and safety of SGLT-2 inhibitors in improving metabolism of pre-diabetic patients are still unclear. The purpose of this experiment is to evaluate the effect of SGLT-2 inhibitor on pre-diabetic patients.

NCT ID: NCT05914740 Recruiting - Clinical trials for Varicose Veins of Lower Limb

Feasibility Study of Ultrasound-guided Functional Remodeling of Lower Extremity Superficial Venous Valve

Start date: April 19, 2023
Phase: N/A
Study type: Interventional

In this project, an exploratory study was conducted to perform in situ venous valve remodeling in vivo, evaluate venous valve function after surgery and conduct regular follow-up, collect relevant ultrasonic data before, during and after surgery, and evaluate the safety and effectiveness of Ultrasound-guided percutaneous great saphenous vein valve functional remodeling.

NCT ID: NCT05914662 Recruiting - Clinical trials for Waldenstrom Macroglobulinemia

Zanubrutinib Plus BR in Newly Diagnosed Symptomatic WM

ZBR
Start date: February 15, 2023
Phase: Phase 2
Study type: Interventional

This study aims to evaluate the long-term efficacy of BTK inhibitor Zanubrutinib combined bendamustine and rituximab (ZBR) for time-limited treatment of Waldenstrom macroglobulinemia, The combination therapy is expected to improve the remission depth, prolong the remission time, and improve the progression-free survival and overall survival of newly diagnosed WM patients. On the one hand, the patients have to bear a long-term economic burden, which is often difficult for some patients to adhere to for a long time. On the other hand, in the course of long-term treatment of BTKi, drug resistance and intolerable side effects are prone to occur. At the same time, it can prevent the disease rebound after the withdrawal of BTKi, so as to achieve the phased withdrawal of WM

NCT ID: NCT05914623 Recruiting - Clinical trials for Transcranial Magnetic Stimulation

Effects of High-frequency Repetitive Transcranial Magnetic Stimulation on Cerebral Autoregulation in Patients With Cerebral Small Vessel Disease

Start date: June 25, 2023
Phase: N/A
Study type: Interventional

The purpose of this study was to investigate the effect of high-frequency repetitive transcranial magnetic stimulation on cerebral autoregulation in patients with cerebral small vessel disease.

NCT ID: NCT05914545 Recruiting - Clinical trials for Advanced and Metastatic Solid Tumor

A Study of FZ-AD004 in Patients With Advanced Solid Tumors

Start date: June 12, 2023
Phase: Phase 1
Study type: Interventional

This study is one single group of participants with advanced solid tumors. It is the first time the drug has been used in humans. There will be two parts including Dose Escalation and Dose Expansion to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of FZ-AD004.

NCT ID: NCT05914428 Recruiting - Sepsis Clinical Trials

Biomarkers to Predict Acute Respiratory Distress Syndrome(ARDS) in Patients With Sepsis

Start date: June 13, 2023
Phase:
Study type: Observational

Sepsis-induced acute respiratory distress syndrome (ARDS) is a life-threatening acute inflammatory lung injury, associated with increased pulmonary microvascular permeability, increased lung weight, and loss of aerated lung tissue.Despite advances in critical care, no established and targeted treatment for ARDS, contributing to a persistently high mortality rate of 34% to 45%. Therefore, exploring novel therapeutic targets for septic ARDS is of paramount importance.Acetaldehyde dehydrogenase 2 (ALDH2) is a mitochondrial enzyme that serves as the primary toxic aldehyde scavenger and is expressed in various cells, including neutrophils. The ALDH2 rs671 single nucleotide polymorphism, leading to an approximate 90% decrease in ALDH2 enzymatic activity, is implicated in occurrence of macrovascular conditions, such as coronary artery disease, pulmonary arterial hypertension, and aortic aneurysm or dissection.An array of studies has delved into role of ALDH2 in regulating cellular processes, including inflammation, autophagy, apoptosis, necrosis,efferocytosis and pyroptosis.but whether it associated with the incidence of septic-ARDS remains unknown.The aim of this study was to determine whether the ALDH2 rs671 single nucleotide polymorphism was associated with the incidence of septic-ARDS.

NCT ID: NCT05914402 Recruiting - Breast Cancer Clinical Trials

Axillary Surgery De-escalation After Neoadjuvant Therapy Using Dedicate Breast PET

NeoaPET
Start date: June 18, 2023
Phase: N/A
Study type: Interventional

Some breast cancer patients with initial axillary metastasis can achieve axillary complete pathological remission(A-pCR) after neoadjuvant therapy(NAT),These patients are candidates for axillary Surgery de-escalation. This prospective study is designed to evaluate the feasibility and safety of axillary surgery de-escalation for the initial axillary metastasis breast cancer patients who are predicted to achieve A-pCR using multiple pathological indicators and imaging examinations (molecular typing, ultrasound and dedicated breast positron emission tomography, etc.) before and after 1-2 cycles NAT

NCT ID: NCT05914389 Recruiting - Colon Neoplasm Clinical Trials

Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer

ICONIC
Start date: August 2023
Phase: Phase 2
Study type: Interventional

This study aims to elucidate the regression effects of neoadjuvant chemotherapy combined with immunotherapy and adjuvant therapy in locally advanced MSS colon cancer.

NCT ID: NCT05914376 Recruiting - Clinical trials for Advanced Solid Tumors

Safety of Recombinant Human IL-21 Oncolytic Vaccinia Virus Injection(hV01) in Advanced Tumors

Start date: July 5, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to evaluate the safety, tolerance, pharmacokinetics, and biological properties of recombinant human IL-21 oncolytic vaccinia virus injection (hV01) in patients with advanced solid tumors.

NCT ID: NCT05914272 Not yet recruiting - Stroke Clinical Trials

Association of Osmotic Drugs With Clinical Outcomes in Acute Large Hemispheric Infarction

Start date: July 1, 2023
Phase:
Study type: Observational

Stroke remains the second leading cause of death worldwide, with 2%-8% of these being large hemispheric infarction (LHI) with an occupying effect and the worst prognosis. Even with medical and surgical treatment, the mortality of LHI with cerebral edema is as high as 20% to 30%. Current guidelines recommend supportive supervision, osmotic drugs, and decompressive hemicraniectomy (DHC) for the treatment of LHI, but not all patients with LHI are suitable for DHC, and not all of them can afford the high cost of DHC. In the real-world, the use of osmotic drugs is more common than DHC. The guideline recommends using mannitol or hypertonic saline to reduce cerebral edema and tissue displacement in patients with cerebral edema. Mannitol is the most widely used and longest-standing osmotic drug, and since 1965, hypertonic saline has been used to treat intracranial hypertension. Most of the previous studies compare the efficacy of DHC over medical therapy or compare the efficacy of mannitol with hypertonic saline, but there is an absence of clinical data on whether osmotic drug therapy can improve the clinical prognosis of patients with large hemispheric infarction at 90 days or even longer. Therefore, the purpose of this study was to investigate the association between the osmotic drug and clinical outcomes in large hemispheric infarction, with the aim of informing clinical decisions.