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NCT ID: NCT05920174 Not yet recruiting - Tetraplegia Clinical Trials

Clinical Trial to Evaluate the Safety and Efficacy of an Implantable Neural Acquisitor & Stimulator System in Patients With Motor Disability

Start date: July 2023
Phase: N/A
Study type: Interventional

Through brain-computer interface alternative technology, patients can control the external equipment(wheelchairs, robotic arms, the WeChat app and other physical aids)with brain signals to improve the patients quality of life.

NCT ID: NCT05919368 Not yet recruiting - Sarcopenia Clinical Trials

The Shape Regulation Mechanism of Yam Pill on Patients With Sarcopenia Based on Intestine-muscle-brain Axis

Start date: September 12, 2023
Phase: N/A
Study type: Interventional

The main manifestation of sarcopenia is the decline of muscle strength, quality, and physical function, and it has the characteristics of overlapping, changing, or transforming with cognitive and emotional problems, belonging to the category of physical and mental diseases. At present, the effective treatment and mechanism of the disease are still unclear. The team's preliminary study found that the Jingfang Yam pill has unique advantages in "spleen dominates muscle", which can significantly improve the skeletal muscle mass, strength, and endurance of mice. The intestine-muscle-brain axis-spleen deficiency may be the key pathogenesis of sarcopenia. As such, the study proposes a hypothesis: whether Yam pills intervene in patients with sarcopenia is achieved bidirectional balance regulation of the body through the bidirectional communication pathway of the muscle-brain axis regulated by the intestinal flora. This project applies a randomized, placebo-controlled, double-blind RCT study design, with sarcopenia patients as the research objects, and utilizes musculoskeletal ultrasound, gut microbiota, untargeted metabolomics, functional near-infrared imaging, and other multidisciplinary techniques. To explore the mechanism of Yam pill regulating patients with sarcopenia by regulating intestinal microecology and metabolism-related molecules mediated by the "intestine-muscle-brain axis".

NCT ID: NCT05919095 Not yet recruiting - Clinical trials for Unresectable Gallbladder Cancer

A Clinical Study of a Preoperative Translational Therapy for Unresectable Gallbladder Cancer

Start date: June 30, 2023
Phase: Phase 2
Study type: Interventional

This is an open-label,multicenter ,non-randomized,single arm exploratory study. The objective of this study is to evaluate the efficacy and safety of PD-1 antibody plus GEMOX as preoperative translational therapy for unresectable gallbladder cancer.

NCT ID: NCT05918276 Not yet recruiting - CLL/SLL Clinical Trials

Clinical Study of Orelabrutinib Combined With BG Regimen First-line Treatment of CLL/SLL

CLL-OBG
Start date: July 15, 2023
Phase: Phase 2
Study type: Interventional

This study aims to investigate the treatment of navie CLL/SLL with orelabrutinib, bendamustine and obinutuzumab . The primary endpoint is the rate of CR and uMRD, and the second endpoints are survival time (OS and PFS) and toxicities.

NCT ID: NCT05917418 Not yet recruiting - Malnutrition Clinical Trials

Nutritional Support on Outcomes and Cost-effectiveness for Patients at Risk

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

The impact of nutritional support for the patients at nutritional risk on clinical outcomes and cost-effectiveness.

NCT ID: NCT05915481 Not yet recruiting - Clinical trials for Advanced Solid Tumor

Stereotactic Body Radiotherapy Combined With Cadonilimab for Advanced Refractory Malignant Solid Tumors

SCARCE
Start date: June 21, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this multicenter prospective single-arm phase I/II study is to study the safety and efficacy stereotactic body radiotherapy (SBRT) combined with Cadonilimab for advanced refractory malignant solid tumors. The main questions it aims to answer are: - How safe is this regimen of SBRT combined with Cadonilimab for advanced refractory malignant solid tumors? - How effective is this regimen of SBRT combined with Cadonilimab for advanced refractory malignant solid tumors? Participants will receive SBRT combined with Cadonilimab until disease progression or intolerable toxicities or death.

NCT ID: NCT05915312 Not yet recruiting - Clinical trials for Major Depressive Disorder

Exosome for Early Diagnosis of Bipolar Affective Disorder

Start date: June 15, 2023
Phase:
Study type: Observational

Objectives: Bipolar disorder (BD) is a chronic and recurrent mental illness characterized by depressive episodes and manic or hypomanic episodes, leading to severe functional impairment and cognitive damage. Unfortunately, it is difficult to accurately distinguish between major depressive disorder (MDD) and BD in the early stages, resulting in misdiagnosis and mistreatment. According to statistics, only 20% of BD patients with initial depressive symptoms receive a correct diagnosis within the first year of onset, with an average delay of 5-10 years from onset to final diagnosis. BD patients are often treated with antidepressant medication systematically due to being diagnosed with MDD, affecting the disease course and clinical outcomes. The current study aims to explore the role of peripheral exosomes as biomarker to distinguish BD from MDD in early stage. Methods: The study includes two stages: the first stage is a case-control study, comparing the concentrations of peripheral blood exosome metabolites (microRNA and related proteins) among three groups (BD patients, MDD patients, and healthy controls, n=30 per group) to identify target microRNA and proteins with statistically significant differences. The "latent class analysis (LCA)" on target microRNA and protein will be performed on all samples to observe whether it can effectively distinguish bipolar disorder, depressive episode, and healthy participants. Then, based on the LCA analysis results, "receiver operating characteristic (ROC)" analysis will be conducted to further determine the optimal concentration cut-off value for each indicator and ultimately determine the target biomarkers. The second stage is a clinical validation study in which subjects, who come from an on-going trial and initiated with a depressive episode and were followed up for five years at least, are divided into two groups (MDD group and BD group, n=20 respectively) based on whether they have hypomanic/manic episodes currently or previously, according to the DSM-5 diagnosed with SCID-5. All target biomarkers will be test in peripheral blood samples reserved at the initial stage to detect whether the diagnosis indicated by the biomarkers is consistent with diagnosis by DSM-5. As well as the accuracy of predicting diagnosis, the correlation between specific biomarkers and treatment response, clinical outcome, and adverse reactions will also be observed. Discussion: It is difficult to explore central nervous system diseases through the peripheral system in the context of the blood-brain barrier. However, exosomes can freely pass through the blood-brain barrier and serve as a good medium for connecting the peripheral system and the central nervous system. This study aims to explore plasma exosome microRNAs and related proteins as biological markers for early diagnosis of bipolar disorder, for example, which microRNAs or proteins are presented in the BD patient group, or what concentrations of microRNAs or proteins are significantly different between the BD patients and MDD patients. Improving the early diagnosis of BD would help develop appropriate clinical intervention strategy, improve the quality of disease management, and significantly reduce the burden of disease. At the same time, this study is also hope to provide a theoretical basis for exploring the pathogenesis of bipolar disorder.

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: 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.

NCT ID: NCT05914103 Not yet recruiting - Clinical trials for Enhanced Recovery After Surgery

The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in the Correction of Complex Congenital Heart Disease

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

This study is a multicenter, stepwise design, cluster randomized controlled trial. Random sequence is generated by computer, and each center enters the intervention expectation (Phase I) in random order to implement ERAS strategy. If it does not enter the intervention expectation (Phase C) center, clinical diagnosis and treatment will be completed according to the traditional scheme. Among children, patients aged 28 to 6 who underwent cardiac surgery were included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative comfort for the patient, preoperative oral sugary beverage, continuous infusion of dexmedetomidine, multimodal analgesia, blood protection strategies, prevention of postoperative nausea and vomiting, intraoperative insulation, early tracheal extubation and intubation, and targeted liquid therapy. The traditional plan group follows the current clinical diagnosis and treatment routine. By comparing the differences in the incidence of major postoperative outcomes (MACE events, major pulmonary complications, and acute kidney injury) between the intervention group and the non intervention group, as well as comparing other adverse events (including but not limited to pneumonia, massive bleeding, postoperative arrhythmia, incision infection, postoperative nausea, vomiting, and delirium), all cause secondary intubation, and all cause secondary surgery between the two groups, and recording hospitalization time, ICU stay time The removal time of tracheal intubation and drainage tube, the pain score during hospitalization, the total amount of opioid drug use (converted to the same dose of morphine), hospitalization expenses, and family satisfaction scores were recorded to explore whether the ERAS regimen can reduce the incidence of major postoperative adverse events, improve patient prognosis, and accelerate postoperative recovery compared to traditional regimens.