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NCT ID: NCT06076200 Recruiting - Clinical trials for Early-Onset Neonatal Sepsis

Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations

Start date: September 30, 2023
Phase:
Study type: Observational

The purpose of this study is to describe the population pharmacokinetic characteristics of piperacillin/tazobactam after intravenous administration in pregnant women during pregnancy and delivery, and to evaluate pharmacodynamic effectiveness and safety of piperacillin/tazobactam in pregnant women whose baby are at high risk of developing early-onset sepsis after birth.

NCT ID: NCT06076135 Recruiting - Radiotherapy Clinical Trials

Intestinal Low Dose Radiotherapy Combined With Immunotherapy in Immune-resistant Metastatic Solid Tumors

ILDRV1
Start date: December 26, 2023
Phase: Phase 2
Study type: Interventional

Preclinical and clinical studies have shown that intestinal low dose radiotherapy (ILDR) can enhance antitumor immunity and response to immune checkpoint blockade (ICB) by regulating intestinal flora. Therefore, the investigators design a phase II trial to validate the clinical value of combining ILDR and programmed cell death-1 (PD-1) inhibitors in patients with metastatic malignant solid tumors who have failed immunotherapy. The primary endpoints of this analysis are disease control rate (DCR), progression free survival while receiving second-line therapy (PFS2), and objective response rate (ORR). The secondary endpoints are the incidence of adverse events (AEs) and the overall response rate. This study is a researcher-initiated, prospective clinical study. The target population is patients with advanced metastatic malignant solid tumors who have progressed after immunotherapy. Thirty participants will be enrolled in this study. The primary objective of the study is to evaluate the efficacy and safety of ILDR combined with PD-1 inhibitors in immune-resistant metastatic malignant solid tumors, and the effect of ILDR combined with PD-1 inhibitors on the intestinal flora. Treatment will be given to patients who meet the eligibility criteria after obtaining their written informed consent. Subjects will be allocated into 3 groups. The jejunum and ileum will be selected and performed with low dose radiation of 1Gy/F, 1F/W, 1Gy-3Gy. The immunotherapy regimen is determined by the doctor in charge based on the patient's clinical status, original immunotherapy regimen, radiological findings, and pathological results. Immunotherapy is administered in combination with radiotherapy, with a treatment frequency of once every 3 weeks until progression. Assess the occurrence rates of DCR, PFS2, ORR, and AEs in accordance with the guidelines for response criteria for use in trials testing immunotherapeutics (iRECIST) to determine the extent of benefit for patients participating in this trial. At least one accessible and measurable lesion should be selected as the target lesion for observation. Furthermore, tissue samples, stool samples, and peripheral blood samples will be collected to assess the effect of this treatment on immune status and intestinal flora.

NCT ID: NCT06076057 Recruiting - Clinical trials for Heart Rate Monitoring

Vital Signs Monitoring of Emergency Responders in Different States

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

The goal of this observational study is to learn about emergency responder in different states. The main questions it aims to answer are: - Ten vital signs and behavioral parameters in different states (quiet, after post, after physical training) including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), partial pressure of end-expiratory CO2 concentration, partial pressure of transcutaneous oxygen, and partial pressure of transcutaneous carbon dioxide. - Eight vital signs and behavioral parameters in different environments (altitude, confined space, energized work, job site) including: respiratory rate, pulse rate, oxygen saturation, body position, chest and abdominal respiratory movements, electromyography (EMG), electroencephalogram (EEG), and partial pressure of end-expiratory CO2 concentration. Participants will normal operating conditions, the researcher collects vital sign information.

NCT ID: NCT06076044 Recruiting - Healthy Subjects Clinical Trials

Effects of Transcranial Oscillatory Direct Current Stimulation on the Functions of Cerebral Cortex in Healthy Subjects

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

To investigate the effect of transcranial oscillatory direct current stimulation on functions of cerebral cortex (cortical excitability and frequency of eeg) in healthy subjects

NCT ID: NCT06075979 Recruiting - Clinical trials for Gene Product Sequence Variation

Correlation Between Microbial Infection and Lumbar Degenerative Disease Based on High-throughput Gene Sequencing

Start date: April 2, 2024
Phase: N/A
Study type: Interventional

Lumbar degenerative disease is one of the most common diseases in orthopedic and spinal surgery. The pathogenesis of lumbar degenerative disease is still unclear, mainly including aging degeneration and biomechanical hypothesis. In our previous research work,the investigators took lumbar disc tissue from patients who underthe investigatorsnt surgical treatment for lumbar degenerative diseases. The investigators found that some patients had low-toxic bacterial infection in the intervertebral disc tissue. Combined with literature and previous studies, it is suggested that microbial infection plays a role in lumbar degenerative diseases. The investigators suggest that microbial infection may be closely related to the occurrence and development of lumbar degenerative diseases, which may cause or even accelerate the degeneration of lumbar intervertebral disc tissue. The current research difficulties are as follows: 1. Low sensitivity and specificity of microbial analysis; 2. It is difficult to distinguish the colonization infection of intervertebral disc tissue microorganisms from the contamination of foreign substances. In view of this, this study intends to use the high-throughput gene sequencing technology of infectious pathogens based on nano single molecule sequencing, double verification of blood samples and intervertebral disc tissue samples, to identify the microbial status of degenerative lumbar disc tissue, and to explore the correlation between lumbar degenerative disease and microbial infection, identifying relevant susceptible microorganisms, which is expected to study the pathogenesis of this susceptible microorganism in the future, and provide new ideas and approaches for the prevention, control and treatment of lumbar degenerative diseases.

NCT ID: NCT06075966 Enrolling by invitation - Clinical trials for Lumbar Degenerative Disease

The Study of INTRA Spine Non Fusion Technique in the Treatment of Lumbar Degenerative Disease

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Lumbar degenerative diseases such as lumbar disc herniation (LDH) and lumbar spinal stenosis (LSSS) are common and frequently encountered in orthopaedics. With the acceleration of the aging process of society, their incidence rate increases year by year. At present, conservative treatment is the preferred choice for this type of disease, and surgical treatment is feasible in cases where conservative treatment is ineffective. The main surgical methods include simple laminectomy and nucleus pulposus removal, intervertebral fusion and internal fixation, intervertebral disc replacement, and non fusion surgery. Simple nucleus pulposus removal surgery has drawbacks such as loss of intervertebral height and foramen height, which can affect spinal stability; Intervertebral fusion and internal fixation surgery has the problem of accelerating adjacent segment degeneration; The current therapeutic effect of lumbar disc replacement is not yet clear, and the technology is not yet mature. In response to the shortcomings of the above surgical methods, the advancement of science and technology has driven the development of spinal surgery, and a new surgical concept has emerged - spinal non fusion fixation technology. The INTRA-Spine dynamic stability system between vertebral lamina is one of the non fusion technologies of the spine. The core concept of this technology is to provide dynamic fixation on the basis of sufficient decompression of nerves, with the rotation center located between the vertebral lamina, which is closer to the normal movement center of the lumbar spine. It simulates the normal physiological structure of the lumbar spine with minimal damage and trauma, and maximizes the preservation of surgical segment mobility while maintaining spinal stability, Reducing stress concentration in adjacent segments caused by local fusion, thereby reducing the acceleration of adjacent segment degeneration, theoretically has good clinical and imaging efficacy.

NCT ID: NCT06075394 Completed - Psoriasis Clinical Trials

Hypertension, Antihypertensive Medication Use, and Risk of Psoriasis

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

The influences of hypertension and antihypertensive medication on psoriasis have been long discussed. Given the limited and inconsistent evidence available, there is a need to further explore and clarify the relationship between hypertension and psoriasis, as well as to assess the relationship between antihypertensive medication use and the development or worsening of psoriasis symptoms. The aim of this retrospective study was to analyze data from electronic health records in a large population-based cohort, and the investigators aimed to investigate whether there was a significant association between hypertension and the use of related antihypertensive medications, such as ACEis, and psoriasis, and to explore potential confounders that may influence this association. Understanding the potential relationship between antihypertensive medication and psoriasis is critical, as this may have implications for the management of hypertension in patients with psoriasis or those at risk of developing the condition. This study will contribute to the existing body of evidence and provide valuable insights for clinicians to make informed decisions about the use of antihypertensive medication in this patient population, ultimately contributing to more effective prevention and management strategies for individuals affected by these diseases.

NCT ID: NCT06075342 Completed - Clinical trials for Intracardiac Hemodynamic

Intracardiac Hemodynamics and Myocardial Strain in Athletes

IHMSA
Start date: March 1, 2021
Phase:
Study type: Observational

The goal of this observational study is to compare the differences of intracardiac hemodynamics and myocardial strain in athletes with different training levels to adapt to long-term high-level training in rest conditions. The main questions aim to answer are: 1. whether an increase in amplitude and duration of intracardiac hemodynamics and myocardial strain compared with healthy controls; 2. Whether significant correlations exist between the hemodynamic indices and training level. Participants will be asked to filling out the questionnaire, such as the age, training year (the number of years the athlete has participated in any sport), technical hierarchy (promoted by the Competitive Sports Department of the General Administration of Sport of China, weekly training time in the last 6 months, height, weight, body surface area, heart rate, systolic blood pressure, and diastolic blood pressure; and will be asked to perform an examination of transthoracic echocardiography. Researchers will compare differences of cardiac structure and function, especially the hemodynamics and myocardial strain to see if training level could affect the cardiac function through hemodynamics and myocardial strain.

NCT ID: NCT06075290 Recruiting - Neonatal Jaundice Clinical Trials

the Difference of Follow-up Methods of Neonatal Jaundice

NJFU
Start date: October 10, 2023
Phase:
Study type: Observational

The goal of this observational study is to compare the effectiveness and efficiency for precaution of severe hyperbilirubinemia in neonate by different follow-up methods of neonatal jaundice. There are two kinds of follow-up methods in the investigators clinical practice. The one is internet plus follow-up model, the other is conventional clinic follow-up method. Parents of the participant neonates can choose one by themselves. After parents of the participant signed informed consent, the investigators recorded several information including severe hyperbilirubinemia, length of phototherapy, follow-up times, et al. Then the investigators analysed these data in order to know what kind of follow-up method is better to prevent severe hyperbilirubinemia and more easy to be accepted.

NCT ID: NCT06075238 Not yet recruiting - Leukemia, Lymphoid Clinical Trials

Blinatumomab Prevents Recurrence of R/R ALL After Allo-HSCT

Start date: October 1, 2023
Phase: Phase 2
Study type: Interventional

The goal of this phase I/II clinical trial is to test in relapsed or refractory acute lymphoblastic leukemia (R/R ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is: • The efficacy and safety of blinatumomab maintenance therapy in reducing the recurrence rate a in R/R ALL patients after allo-HSCT. Participants will take intravenous blinatumomab after allo-HSCT. The dose of one course was as follows: day 1-2: 8ug/day, continuous intravenous drip for 24 hours, day 3-7: 16ug/day, continuous intravenous drip for 24 hours. Treatment with blinatumomab was initiated within 60 to 90 days after transplantation and was administered bimonthly until 1 year after transplantation. Dexamethasone 20mg was administered 1 hour before administration on days 1 and 3 to prevent adverse events.