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NCT ID: NCT05359588 Recruiting - Clinical trials for Cerebral Small Vessel Diseases

Functional Prognosis of Post-operative Patients With Cerebral Small Vascular Disease(CSVD)

Start date: January 31, 2022
Phase:
Study type: Observational

The investigators perform a retro-prospective exploratory cohort study among patients 65 to 85 years old with pre-operative head MRI result after thoracic surgery in Renji Hospital Affiliated to Shanghai Jiaotong University from November 2020 to December 2021. Perioperative data were collected, including preoperative general condition, laboratory examination, auxiliary examination (blood routine, blood coagulation, liver and kidney function, etc.), perioperative indicators (use of anesthetics, anesthetic time, blood pressure, etc.), postoperative cerebral function follow-up and occurrence of cerebral vascular complications (brain infarction, brain bleed, etc.) of patients.

NCT ID: NCT05359354 Recruiting - Solid Tumor Clinical Trials

Safety and Efficacy of Personalized Neoantigen Vaccine in Advanced Solid Tumors

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

This trial is an investigator-initiated, single-center, open-label, single-arm exploratory study of mRNA personalized neoantigen tumor vaccine in the treatment of advanced solid tumors, including two phases: dose escalation and dose expansion. The main objective is to evaluate the safety and tolerability of personalized neoantigen tumor vaccine in subjects with advanced solid tumors, and secondary objective is to preliminarily evaluate the efficacy of personalized neoantigen tumor vaccine in subjects with advanced solid tumors. According to the characteristics of safety and efficacy data in the dose escalation phase, the dose expansion is performed at the intended clinical dose based on the investigator's judgment, and the treatment will be performed in combination with PD-1 to further evaluate the efficacy and safety profile of personalized neoantigen tumor vaccine at a specific dose. Both the dose escalation phase and dose expansion phase include a screening period (Week -4 ~ Week -2), a baseline period (Week -1 ~ Day -1), a treatment period (Day 1 ~ Week 8 or 16), and a follow-up period. Subjects who signed and provided the formal informed consent entered the screening period. The treatment period included the initial treatment period (Day 1 ~ Week 8) and the enhanced treatment period (Week 12 ~ Week 16). The investigator determine if the subject is suitable to enter the enhanced treatment period based on the comprehensive judgment of the subject's efficacy, safety, compliance and other factors. Dose escalation phase is the traditional 3 + 3 design,, 12-18 subjects are expected to be enrolled at 100 μg, 200 μg and 400 μg (3-6 subjects in each group). The low dose group will be enrolled first. The investigator will choose the optimal clinical dose for dose expansion, which can be one dose group or multiple dose groups. PD-1 will be administered in parallel to further confirm the efficacy and safety of neoantigen tumor vaccine. About 18 subjects will be enrolled. The usage and dosage of PD-1 should aligned with the package insert.

NCT ID: NCT05359120 Recruiting - Breast Cancer Clinical Trials

Pyrotinib Combined With Capecitabine in HER-2 Positive Advanced Breast Cancer and Brain Metastases (Post-PERMEATE)

Start date: May 30, 2022
Phase:
Study type: Observational

This study aims to describe the different treatment time, treatment mode and clinical outcomes of pyrotinib maleate tablets combined with capecitabine in the treatment of patients with HER-2 positive advanced breast cancer with brain metastases.

NCT ID: NCT05358899 Recruiting - Schizophrenia Clinical Trials

Accelerated cTBS on Metabolic Dysfunction in People With Schizophrenia

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

cTBS is a promising novel intervention, which has strong potential on moderating disease syndrome. However, the most effective pattern of the cTBS is still under debate. Therefore, the investigators designed this randomized controlled clinical trial to evaluate the efficacy and safety of accelerated cTBS, with 1800 stimulation per session, on intervention to metabolic side effects in individuals with schizophrenia.

NCT ID: NCT05357872 Recruiting - General Anesthesia Clinical Trials

Dreaming During Anesthesia and Anesthetic Depth in Elective Surgery Patients Under General Anesthesia

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

Dreaming is a common, enduring, and fascinating part of the anesthetic experience, but its cause and timing remain elusive. Patients typically report that they were dreaming during anesthesia, but the actual timing of anesthetic dreaming is unknown. The following evidence supports the hypothesis that dreaming occurs intraoperatively and is related to light or inadequate anesthesia: (1) The incidence of dreaming has decreased as anesthetic techniques have improved; (2) dreamers exhibit more clinical signs of light anesthesia or report more awareness than non dreamers; (3) dreamers may receive lower doses of anesthetic drugs than non dreamers and emerge more rapidly from anesthesia; (4) the content of dreams may involve surgical topics or events occurring during anesthesia; and (5) in one study, the incidence of dreaming was lower in Bispectral Index (BIS)-monitored patients. Alternatively, dreaming may occur during emergence from anesthesia, when the brain is still affected by sedative concentrations of anesthetic drugs and the patient enters a sleep state. Few studies have assessed the relation between dreaming and depth of anesthesia, and their results were inconclusive.Most recently, in the B-Aware Trial, no differences in depth of anesthesia, as measured by BIS, were detected between dreamers and non dreamers. However, the patients were at high risk of awareness, and BIS data were collected manually and were only recorded in the BIS group and during maintenance. No studies investigating the relation between dreaming and depth of anesthesia during recovery were identified. Why is the investigation of dreaming during anesthesia important? Dreaming is one of the most common side effects of anesthesia but remains puzzling and requires explanation. Dreaming is sometimes distressing to patients and may decrease satisfaction with care. Some patients who report dreaming fear that their anesthetic was inadequate and that their experience was, in fact, awareness. Indeed, in a minority of cases, dreaming may truly represent near-miss awareness. The investigators therefore tested the hypothesis that dreaming during anesthesia is associated with light or inadequate anesthesia, as evidenced by higher median BIS values during maintenance of anesthesia. The investigators also explored the depth of anesthesia until emergence, the form and content of dreams, the predictors of dreaming during anesthesia, and the effect of dreaming on quality of recovery and satisfaction with anesthetic care

NCT ID: NCT05357846 Recruiting - Esophageal Cancer Clinical Trials

PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)

Start date: November 1, 2022
Phase: Phase 3
Study type: Interventional

The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.

NCT ID: NCT05357651 Recruiting - Lymphoma Clinical Trials

A Study to Assess the Safety and Efficacy of LB1410 in Participants With Advanced Solid Tumor or Lymphoma(Keyplus-001)

Start date: August 12, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase I study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, LB1410, is safe, tolerable and efficacious in participants with advanced solid tumors or lymphoma.

NCT ID: NCT05357456 Recruiting - Clinical trials for Adrenal Incidentaloma

Performances on Cognitive Functions and Brain Function and Follow-up After Different Treatments in Patients With Autonomous Cortisol Secretion: a Single-center, Prospective, Observational Study

Start date: October 1, 2021
Phase:
Study type: Observational

This is a single center, prospective, observational study to explore and evaluate the differences on cognitive function and brain function by functional-MRI in autonomous cortisol secretion patients, and the different treatments methods on the cognitive function and brain function in patients with autonomous cortisol secretion

NCT ID: NCT05357430 Recruiting - Gastroenterology Clinical Trials

The Application of Remazolam in Gastroenteroscopy

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

OBJECTIVE: To study the safety, efficacy and clinical significance of remimazolam in the diagnosis and treatment of elderly obese patients with daytime gastrointestinal endoscopy, calculate the optimal dose, and conduct relevant verification. Provide a safer and more effective anesthesia solution for the growing special population. METHODS:Around 160 patients were selected to receive painless gastroenteroscopy.,they were divided into four groups of D1, D2, R and C. Group D1 and D2(including 60 patients) were used to calculate the ED50 and ED95 of the drug. According to up-and-down method, they were slowly injected 0.3μg/kg of remifentanil in advance, then 0.20mg/kg of remimazolam, and gastroscopy was performed after MOAA/S score ≤3. The next patient would be increased 0.05mg/kg of remimazolam if there is a positive standrd, otherwise it would be decreased 0.05mg/kg. And the study was terminated when seven crossing points occurred. One hundred patients were randomly divided into two groups of R and C.Before administration of remimazolam, remifentanil injection 0.3 μg/kg were given intravenously in two groups, respectively (injection rate was 30 s).Then group R was given the calculated dose of remimazolam, and group C was given propofol 1.5-2mg/kg.The success rate of sedation, changes in vital signs, adverse reactions, and postoperative recovery were recorded in the two groups.

NCT ID: NCT05357417 Recruiting - Breast Cancer Clinical Trials

Utidelone Plus Bevacizumab for Advanced Breast Cancer With Brain Metastases

Start date: April 29, 2022
Phase: Phase 2
Study type: Interventional

This study aims to investigate the efficacy and safety of utidelone in combination with bevacizumab in the treatment of advanced breast cancer with brain metastases, and thus provides a new systemic treatment strategy for those patients.