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NCT ID: NCT05628493 Completed - Gut Microbiota Clinical Trials

Gut Microbiota Analysis in IAI Patients With Sepsis-associated Liver Dysfunction

2022-11-09
Start date: January 3, 2022
Phase:
Study type: Observational [Patient Registry]

With the rapid development of intensive care medicine, the mortality of patients with sepsis has decreased over the past decade, but it is still the leading cause of death in intensive care unit (ICU). As an important immune and metabolic organ, the liver plays a crucial role in host defense against invading pathogens and endotoxins, as well as maintenance of metabolic and immunological homeostasis. Some studies indicate that sepsis-associated liver dysfunction (SALD) has a substantial impact on the severity and prognosis of sepsis. Intra-abdominal infections (IAI) are the second leading source of infection for sepsis after pneumonia in ICU, and are often related to high morbidity and mortality rates. Studies had found that the incidence of SALD in IAI patients was considerably higher than that of general population with sepsis. Moreover, the incidence of acute gastrointestinal injury (AGI) in IAI patients was also much higher than that in sepsis patients with other site infections, as well as the degree of AGI was more serious according to guidelines proposed by the European Society of Intensive Care Medicine (ESICM) in 2012. IAI can directly cause AGI, and a subset of patients usually progress to increased intra-abdominal pressure, which further aggravates AGI. The pathogenesis of SALD remains unclear so far, and its mechanism is complicated and elusive. Nevertheless, the unique anatomical structure of the liver make it has close association with the gut, growing evidence indicates that the gut microbiota and related metabolites are related to several liver disease. In case of sepsis, gut microbiota disorder and low microbial diversity can cause severe liver injury. An important mechanism for this phenotype is the gut-liver axis, which refers to gut microbial metabolites and nutrients are transported to the liver through the portal vein and hepatic artery to maintain the healthy metabolism of liver. Therefore, we initially conducted a retrospective study to investigate the relationship between the occurrence of AGI and SALD among IAI patients. Subsequently, a prospective study was performed to analyze and compare the diversity and composition of gut microbiota in IAI patients with or without SALD, respectively, and the dynamic changes in the gut microbiota during the first week after ICU admission were also investigated.

NCT ID: NCT05628480 Completed - Cardiac Disease Clinical Trials

Multi-omics Analyses Reveal Microbiota-gut-brain Axis in ICU Patients With Post-cardiac Surgery Delirium

Start date: July 1, 2022
Phase:
Study type: Observational

This case-control study is planned to recruit patients who meet the enrollment conditions, receive cardiac surgery (cardiac valve surgery or coronary artery bypass surgery) and cardiopulmonary bypass, and sign the informed consent form in the second ward of adult cardiac surgery, Fuwai Hospital. Use RASS, CAM-ICU scales to evaluate postoperative patients and divide them into delirium and non-delirium groups according to whether they had delirium after surgery. There will be 30 patients in each group. Match the two groups in terms of surgical type, duration of cardiopulmonary bypass, gender and age range (± 3 years). Collect and record the preoperative, intraoperative and postoperative data of the enrolled patients, including cardiopulmonary bypass time, ICU stay time, length of mechanical ventilation, hemodynamics and other data. Fecal and/or blood samples are collected from 60 patients before, immediately after and after operation. The laboratory test and analysis shall be started after the collection of clinical samples. Fecal samples are used for Metagenomics Sequencing and Functional genomics. Blood samples are analyzed by serum metabolomics for changes in intestinal metabolites entering the blood circulation. Simultaneous measurement of IL-6 and TNF in peripheral blood with serum samples- α, IL-1a,IFN-γ and LPS, D-lactic acid and diamine oxidase levels.Use Multi-omics approach to analyze the correlation between intestinal flora diversity, functional gene abundance and blood metabolites, inflammation level and intestinal barrier function, and to find the clinical evidence of the correlation between microbiota-gut-brain axis and the occurrence of POD in patients. Through comprehensive analysis of the research results of this experiment, access to literature, write papers, submit papers and publish relevant papers.

NCT ID: NCT05628454 Recruiting - Lung Cancer Clinical Trials

Comparison of Three Different Puncture Techniques in EBUS-TBNA

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

The purpose of this study was to compare the accuracy and sensitivity of slow-pull capillary technique, traditional suction aspiration and non negative pressure puncture in the diagnosis of mediastinal and/or hilar lymph node enlargement by ultrasound bronchoscopic lymph node biopsy.

NCT ID: NCT05628311 Active, not recruiting - Type 2 Diabetes Clinical Trials

A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

Start date: January 6, 2023
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the effectiveness and safety of IBI362 in patients with type 2 diabetes (T2D) with poor glycemia control only through diet and exercise. This study plans to enroll about 300 T2D subjects who still fail to meet the HbA1c standard after at least 2 months of simple diet and exercise control. During the whole study, subjects will be required to maintain diet and exercise control. The whole trial period includes a 2-week screening period, a 6-week introduction period, a 24 week double-blind treatment period, a 24 week study extension period and a 4-week safety follow-up period. Subjects who met the randomization criteria will be randomly assigned to the IBI362 4.0 mg group, the IBI362 6.0 mg group and the placebo group at 1:1:1. The randomization stratification factors were (V3) HbA1c<8.5% or HbA1c ≥ 8.5% before randomization.

NCT ID: NCT05628272 Recruiting - Cord Clinical Trials

MNCs for Bone Marrow Failure After Malignant Diseases Children Chemotherapy

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

This project aims to investigate the therapeutic and repair effects of cord blood mononuclear cells (MNCs) on bone marrow failure after chemotherapy in children with malignant diseases. It is planned to collect 20 malignant children with bone marrow failure after chemotherapy and randomly divide them into two groups. The umbilical cord blood mononuclear cells were injected, ≥1×10^8 per infusion, once a week, and the recovery time of peripheral blood leukocytes, neutrophils, platelets and hemoglobin was observed. According to the recovery of myelosuppression, stop when the peripheral blood reaches leukocytes>1×10^9/L, neutrophils>0.5×10^9/L, platelets>25×10^9/L, and hemoglobin>60g/L at the same time. Use, share 1-4 times. Statistical software was used to compare the changes of peripheral blood leukocytes, neutrophils, platelets and hemoglobin before the start of the test (0d) and 1d, 3d, 5d, 7d, 10d, and 14d after the start of the test, as well as the severity of concurrent infections and antibiotic use Time, number of infusions of blood products.

NCT ID: NCT05628129 Recruiting - Ectopia Lentis Clinical Trials

Effect of Mobile Communication on Congenital Ectopia Lentis Follow-up Adherence

Start date: December 5, 2022
Phase: N/A
Study type: Interventional

Regular follow-up is essential to successful management of congenital ectopia lentis, but it is often ignored by parents in China. With rapid economic development, there are increasing numbers of mobile phone users that allow for communication applications to be used in medical care. The investigators aimed to assess the potential of the smartphone application assisted medical service to increase patient compliance in attendance of follow-up after congenital ectopia lentis treatment.

NCT ID: NCT05628077 Recruiting - Breast Cancer Clinical Trials

Prevalence and Risk Factors for Pain and Related Adverse Reactions Among Breast Cancer Survivors on Aromatase Inhibitors

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

We obtained the occurrence of pain sensation, pain mood, sleep, etc. during endocrine therapy in breast cancer patients through telephone follow-up, and analyzed risk factors through artificial intelligence

NCT ID: NCT05628051 Completed - Clinical trials for General Anesthesia Induction for Elective Surgery

Carotid Artery Corrected Flow Time as a Predictor of Hypotension After Induction of General Anesthesia in Elderly Patients

Start date: June 1, 2022
Phase:
Study type: Observational

The number of elderly patients undergoing elective surgery has been growing in recent years. Elderly patients often have a variety of underlying diseases, including hypertension, coronary heart disease, diabetes, arteriosclerosis, etc., which increase the risk. When the elderly receive general anesthesia, hypotension often occurs after anesthesia induction. Once hypotension occurs, it may lead to myocardial ischemia, myocardial infarction, stroke and other serious complications. Therefore, in clinical anesthesia, a simple, quick and accurate prediction method is needed to evaluate and predict the risk of hypotension in elderly patients after induction, so that appropriate intervention measures can be taken in advance to reduce the incidence of hypotension in elderly patients after induction, thus reducing the occurrence of related complications and ensuring the safety of anesthesia and surgery.Carotid Artery Corrected Flow Time(FTc) is a recently developed volumetric predictor, which refers to the time between the the onset of systolic flow until the closure of the aortic valve. It is related to cardiac preload and can reflect cardiac output to a certain extent. It is considered as a reliable indicator for evaluating volume status and volumetric reactivity. Therefore, this study assessed the effect of FTc combined with perioperative fluid therapy on preventing hypotension after general anesthesia induction in elderly patients.

NCT ID: NCT05628038 Recruiting - Clinical trials for Recurrent Rectal Cancer

The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer

TORCH-R
Start date: August 18, 2022
Phase: Phase 2
Study type: Interventional

The study is a prospective, single-center, single-arm, two-cohort, phase II clinical trial. Patients aged 18 years or older who had pelvic recurrence rectal cancer with or without resectable distant metastasis, with treatment naive disease (cohort A) or progressive disease after first-line chemotherapy (cohort B), Eastern Cooperative Oncology Group performance status of 0-1, will receive 25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (pelvic radiation history), 18 weeks toripalimab and investigator's choice of chemotherapy, and stereotactic ablative radiotherapy (SABR) for all metastatic lesions between chemoimmunotherapy cycles, followed by multidisciplinary team (MDT) for decision:follow-up of complete response (CR), radical surgery, sustained treatment of non resection, or exit. The primary endpoint was local objective response rate. Secondary endpoints were extrapelvic objective response rate, R0 resection rate, duration of response, progression-free survival, overall survival, and safety and tolerability of the treatment. Shanghai Junshi Biomedical Technology Co., Ltd. Provides the first three cycles of toripalimab for free and has purchased liability insurance for clinical trial subjects.

NCT ID: NCT05627856 Recruiting - Clinical trials for Non-Hodgkin Lymphoma

A Study of GNC-038 Injection in Patients With Relapsed or Refractory NK/ T-cell Lymphoma, AITL, and Other NHL

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

To explore the safety and efficacy of GNC-038 in relapsed or refractory NK/T cell lymphoma, vascular immunomother T cell lymphoma, and other relapsed or refractory NHL, and to determine MTD, MAD, DLT, and RP2D of GNC-038, as well as its pharmacokinetic characteristics and immunogenicity.