There are about 36818 clinical studies being (or have been) conducted in China. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This is a single-center, randomized, double-blind, placebo-controlled, escalating single-dose and multiple-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HEC88473 injection in healthy subjects, obese subjects and subjects with type 2 diabetes mellitus (T2DM).
Main objectives: To evaluate the benefit of SI-B001+ docetaxel on overall survival (OS) of bidotaxel. To evaluate the benefit of SI-B001+ Docetaxel over Docetaxel's progression-free survival (PFS) based assessment. Secondary objectives: To evaluate the investigator-evaluated progression-free survival (PFS) benefit of SI-B001+ Docetaxel against docetaxel; To evaluate the difference of objective response rate (ORR), disease control rate (DCR) and duration of response (DOR) between SI-B001+ docetaxel and bidocetaxel. To evaluate the type, frequency and severity of adverse events (TEAE) and drug-related adverse events (TRAE) during treatment with SI-B001+ docetaxel in comparison with docetaxel. The pharmacokinetic (PK) characteristics of SI-B001 will be evaluated. The immunogenicity of SI-B001 will be evaluated. Subject quality of life.
The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of Hetrombopag plus high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).
The goal of this study is to compare the postoperative anal function of patients with ultra-low rectal cancer after Parks operation (colon anal anastomosis) and Bacon operation (colon anal pull-out anastomosis), which may provide clinical evidence for the improvement of anal function and quality of life. The main questions it aims to answer are: the difference of anal function 1 year after surgery type of study: clinical trial participant population: patients with low rectal cancer Participants will receive Parks operation of Bacon operation If there is a comparison group: Researchers will compare Parks and Bacon operation to see if the anal function 1 year after surgery is different.
Background: Recently, there has been increasing attention on the application of transcutaneous auricular vagus nerve stimulation (taVNS) in ischemic stroke. This innovative technique involves non-invasive electrical stimulation of the vagus nerve. A controlled study by Dawson et al. (2021), conducted using a randomized, double-blind approach, has demonstrated that vagus nerve stimulation (VNS) when paired with motor function training, can effectively promote the improvement of motor dysfunction in stroke patients. In the same year, the Food and Drug Administration approved the use of VNS, alongside motor rehabilitation training, for upper extremity dysfunction caused by stroke. However, it is worth noting that VNS requires surgical procedures with contraindications. Consequently, researchers are exploring taVNS as a potential alternative intervention. Compared to VNS, taVNS offers a low-risk and user-friendly intervention that eliminates the need for surgery and the associated postoperative complications. A recent meta-analysis has shown that the efficacy of taVNS in upper extremity rehabilitation for stroke patients can be comparable to that of VNS. Therefore, pairing taVNS with motor training holds promise as a valuable clinical tool for post-stroke rehabilitation. Methods and Design: This study presents a protocol for a single-center randomized, double-blind controlled trial. A total of 150 participants will be enrolled and randomly assigned to one of three groups (Group 1, Group 2, or Group 3) in a 1:1:1 ratio. Each patient will undergo a total of 14 treatment sessions. In Group 1, patients will receive motor training paired with taVNS. In Group 2, patients will receive motor training and taVNS interventions, seperately. In Group 3, patients will receive motor training paired with sham taVNS. Primary and secondary outcome measures will be assessed at baseline and after taVNS treatment. The primary outcome will be determined by evaluating the behavioral response to treatment, using the Fugl-Meyer Assessment of Upper Extremity (FMA-UE). Discussion: This study aims to elucidate the role of paired taVNS in the rehabilitation of upper extremity dysfunction in stroke patients. The researchers propose a novel approach by pairing taVNS with individualized training actions, utilizing electromyography (EMG) during motor training to precisely trigger taVNS.
In this study, participants with high risk non-muscle-invasive bladder cancer (NMIBC) who are BCG Naïve or BCG Unresponsive and are considered ineligible for or have refused to undergo radical cystectomy, will receive RC48-ADC in combination with gemcitabine.
This is a single-center, single-arm, open, intravenous drug administration of the safety and efficacy of clinical study.
Materials and Methods 1. General information This study enrolled 153 patients with congenital glaucoma who were treated at our hospital from January 2021 to December 2022. These patients were divided into an observation group (n = 76) and a control group (n = 77) using a random number table. The inclusion criteria were as follows: (1) meeting the diagnostic criteria for glaucoma, (2) following the attending doctor's recommendations to receive surgical treatment, and (3) volunteering to participate in the study. The exclusion criteria were as follows: (1) severe organic dysfunction, (2) cardiovascular and/or cerebrovascular diseases, (3) hypertension, (4) contraindications for surgery, (5) other eye diseases, (6) communication disorders, and (7) mental illnesses. Informed consent with signature was obtained from every participant, and the study has been approved by the hospital's ethics committee. 2. Research methods The control group was provided with routine care, including warm reception and provision of a quiet, clean, and well-ventilated ward environment for good rest. Patients were educated to broaden their knowledge of the disease and related surgical treatment, particularly the importance and outcomes of surgical treatment, thereby allaying their feeling of fear and boosting their confidence in recovery. Meanwhile, patients were encouraged to break their unhealthy habits, avoid bad diet choices, and take medications on time. The observation group received CBNI described as follows: (1) A cognitive-behavioral intervention group was set up by several nurses who had a background of systematic cognitive intervention training, were able to independently develop comprehensive behavioral intervention plans and assess a patient's cognitive level, and had an adequate understanding of the fundamentals of cognitive behavioral intervention. Through thorough communication with patients, these nurses were supposed to identify their major concerns and assess their cognitive behavior. Based on the assessment results, psychological counseling was provided for every patient, with each session lasting at least 50 minutes. In addition, the nurses were required to reassure all patients by proactively introducing the precautions of surgery and nursing care. (2) Psychological intervention was accessible to those who felt resistant to their treatment plans or developed inferior feelings due to visual impairment to establish a good relationship with patients and help them better cope with unhealthy emotions. Professional education was provided through communication with patients so that they could gain detailed knowledge of the disease. Chatting and music were useful to relieve tension and psychological stress. Regular patient support groups were organized to help patients develop confidence and a positive attitude toward the disease. (3) Health education was provided through self-developed booklets and question-and-answer sessions to publicize the fundamental knowledge and make sure all patients have a full understanding of the disease and related treatments. The nurses were also required to closely monitor patient compliance from the perspectives of diet, lifestyle, psychology, and treatment. (4) Dietary guidelines were set out to encourage a light, healthy diet with fruits and vegetables, free of irritating food, and containing a limited amount of oily food. It should be noted that smooth bowel movements are essential to prevent increased IOP induced by constipation. Therefore, the recommended diet is high in dietary fiber and fruits. (5) Behavioral guidelines were developed to address the importance of quitting tobacco use and prevent eye strain due to excessive eye use with tailored eye care plans. The nurses were responsible for guiding the proper use of eye drops by patients, reminding all patients to seek medical attention immediately if they experienced any eye discomfort, and stressing the risk of increasing IOP due to prolonged periods of looking down and other unhealthy habits. 3. Statistical analysis The software SPSS22.0 was used for data analysis. Measurement data were expressed as "mean ± standard deviation (x±s)", and comparisons between the two groups were examined by the t-test. Enumeration data were represented as percentages (%) and inter-group comparisons were examined using the χ2 test. Significance was set at the level of P <0.05.
Managements for refractory proficient mismatch repair (pMMR) or microsatellite stable (MSS) metastatic colorectal cancer (mCRC) were still challenging and controversial. Our study sought to investigate the efficacy and safety of anti-PD-1 antibodies plus regorafenib in refractory pMMR/MSS mCRC between July 2019 and June 2021 at the Hunan Cancer Hospital.
The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.