Clinical trials

This multicenter randomized controlled trial will compare online Tai Chi (OTC) with digital cognitive behavioral therapy for insomnia (dCBT-I) in adults with chronic insomnia disorder. A total of 172 participants aged 18 to 65 years will be randomly assigned in a 1:1 ratio to receive either a 6-week standardized online Tai Chi intervention or a 6-week structured dCBT-I intervention. Both groups will receive the same standardized sleep hygiene education. The primary objective is to determine whether online Tai Chi is noninferior to dCBT-I in improving insomnia severity at Week 6, as measured by change in the Insomnia Severity Index (ISI) from baseline. Participants will be followed through Week 30. Approximately 120 participants will additionally participate in an actigraphy substudy with 7-day assessments at baseline, Week 6, and Week 30.

This is a Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetic characteristics of the DM1001 transdermal patch in healthy Chinese participants. Eligible participants will receive DM1001 according to the clinical trial protocol. Safety, tolerability, and pharmacokinetic assessments will be conducted at prespecified time points during the study. The study is intended to provide initial information on the safety, tolerability, and pharmacokinetic characteristics of DM1001 in humans.

This Phase 1 study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of continuous intravenous infusion of KL0011034 Injection in healthy Chinese adults. Approximately 30 participants will be enrolled in three sequential infusion-duration cohorts (1, 2, and 3 hours; 10 participants per cohort). Within each cohort, participants will be randomized in a 4:1 ratio to KL0011034 Injection or active-control propofol for anesthesia maintenance. All participants will receive propofol 2 mg/kg for anesthesia induction. Safety, pharmacokinetic, pharmacodynamic, recovery, and anesthesia-satisfaction assessments will be performed through 24 hours after dosing. Progression to the next infusion-duration cohort will occur only after the preceding cohort is considered safe and tolerable.

This is a Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HW243040 in healthy participants. The study consists of two parts: Part A (Single Ascending Dose, SAD) and food effect study, and Part B (Multiple Ascending Dose, MAD). A total of approximately 98 healthy participants will be enrolled.

This Phase 1a, single-center, randomized study will evaluate the safety, tolerability, pharmacokinetics, and relative bioavailability of single-dose DMI019 nasal spray in healthy participants. Approximately 48 healthy male and female participants will be enrolled. The study includes an open-label, two-period crossover part comparing DMI019 nasal spray with oral emedastine difumarate sustained-release capsules, and a double-blind, placebo-controlled, dose-escalation part evaluating three dose levels of DMI019 nasal spray.

This study is designed to characterize a new quantitative method for measuring sweat production induced by controlled heat exposure. Approximately 20 healthy volunteers and up to 10 patients with ROSAH syndrome will be enrolled. Sweat production will be quantified using a gravimetric filter-paper technique during standardized 30-minute heat exposure in a temperature-controlled sauna chamber. Each participant will complete three repeated testing sessions. The study will also pilot a questionnaire to evaluate the self-reported impact and severity of hypohidrosis/anhidrosis.

This is a randomized, double-blind, placebo-controlled, single-ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of SAL0195 injection in participants with or without elevated lipoprotein(a) \[Lp(a)\]. Approximately 40 male and female participants aged 18 to 65 years will be enrolled across five planned dose cohorts. Participants will receive a single subcutaneous dose of SAL0195 or matching placebo.

This Phase 1 study will evaluate a new formulation of HBW-3220 capsules in healthy adults. It will compare how much and how quickly HBW-3220 enters the bloodstream after a single 120 mg dose of the new formulation versus the previous formulation under fasting conditions, and after the new formulation is taken under fed versus fasting conditions. Twenty-one participants will be randomly assigned to one of three treatment sequences and will receive all three treatments during three study periods, with at least 7 days between doses. Blood samples will be collected for pharmacokinetic analysis, and safety and tolerability will be assessed throughout the study and during follow-up.

To evaluate the Efficacy and Safety of the Combination of Sintilimab With Platinum-doublet Chemotherapy and Adaptive Radiotherapy Strategy in the Treatment of Stage III Non-small Cell Lung Cancer Patients

This study compares the pharmacokinetics/pharmacodynamics (PK/PD), safety, and preliminary efficacy of a single 3.75 mg dose of HHK001 (Leuprorelin Acetate Microspheres for Injection, an improved formulation) versus Enantone (Leuprorelin Acetate Microspheres for Injection) in patients with endometriosis. Approximately 20 patients will be enrolled and randomized in a 1:1 ratio to receive a single subcutaneous injection of HHK001 or Enantone. The post-dose blood sampling/follow-up period is 6 weeks for the Enantone group and 10 weeks for the HHK001 group.

The goal of this clinical trial is to evaluate the effects of a couple-based collaborative lifestyle intervention among women with a history of gestational diabetes. The main questions it aims to answer are: Does the intervention improve body mass index and 2-hour plasma glucose after an oral glucose tolerance test? Does the intervention improve health behaviors, psychological well-being, self-efficacy, couple functioning, and life satisfaction? Researchers will compare a couple-based collaborative lifestyle intervention with a woman-only lifestyle intervention to determine whether adding spousal collaboration and support leads to greater improvements. Participants will: Receive healthy lifestyle education posts for 3 months. In the couple-based group, also receive instant messages on behavioral promotion and couple collaboration and support videos.

This study will evaluate the drug-drug interaction between KL0011034 Injection and Alfentanil Hydrochloride Injection in participants with moderate-to-severe non-cancer chronic pain. The study consists of two parts. Part 1 is a single-center, randomized, open-label, parallel-design study to evaluate the safety, tolerability, and pharmacodynamics of the combination. Approximately 9 participants will be enrolled and randomized to one of three dose groups (n=3 per group). Part 2 is a single-center, randomized, open-label, three-sequence, three-period crossover study to evaluate the pharmacokinetic interaction, safety, tolerability, and pharmacodynamic effects. Approximately 18 participants will be enrolled and randomized to one of three sequences (n=6 per sequence), with a 3-day washout period between each period.

This is a single-center, non-randomized, open-label, single-sequence, self-controlled drug-drug interaction study in healthy participants. The main purpose of the study is to evaluate whether a single dose and repeated daily doses of NTQ5082 capsules affect the pharmacokinetics of midazolam oral solution. Midazolam is used in this study as a probe drug to assess the activity of cytochrome P450 3A (CYP3A), an enzyme involved in the metabolism of many medicines. Approximately 18 healthy male and female participants will be enrolled. Participants will receive a single oral dose of midazolam 2 mg on Days 1, 4, and 11. NTQ5082 200 mg will be administered orally once daily from Day 4 through Day 12. Blood samples will be collected to measure the concentrations of midazolam and its metabolite, 1'-hydroxymidazolam, and to calculate pharmacokinetic parameters. The safety and tolerability of midazolam administered alone and together with NTQ5082 will also be evaluated through adverse event monitoring, laboratory tests, vital signs, physical examinations, and electrocardiograms. The study includes a screening and protocol-required vaccination period, an inpatient treatment period, and a safety follow-up telephone call within 7 days after discharge.

Study Title:A Nurse-Led Intervention Program Based on the Common-Sense Model of Self-Regulation for Volume Management in Patients with Chronic Heart Failure: A Randomized Controlled Trial Brief Summary: The goal of this clinical trial is to learn if a nurse-led, theory-driven intervention based on the Common-Sense Model of Self-Regulation (CSM), supplemented by Bandura's Self-Efficacy Theory, works to improve volume management self-care in patients with chronic heart failure. It will also learn about the intervention's effects on illness perception, self-efficacy, quality of life, emotional status, and clinical outcomes. The main questions it aims to answer are: * Does the CSM-based intervention improve patients' self-care capacity as measured by the Self-Care of Heart Failure Index (SCHFI)? * Does the intervention improve patients' illness perception as assessed by the Brief Illness Perception Questionnaire (BIPQ)? * Does the intervention improve patients' self-efficacy, quality of life, emotional status, cardiac function (LVEF, BNP, heart rate, NYHA class), and dry weight attainment? * Does the intervention reduce heart failure-related readmission rates and emergency department visits within 3 months post-discharge? Researchers will compare the CSM-based intervention group to a standard care control group. The standard care group receives routine in-hospital education, a health handbook, and regular telephone follow-ups. Participants in the intervention group will: * Receive a 5-phase, nurse-led program from hospital admission to 3 months post-discharge * Attend bedside interviews and structured lectures on volume overload mechanisms during hospitalization * Complete questionnaires assessing illness perception, self-care, self-efficacy, quality of life, and emotional status at baseline, 1 month, and 3 months * Receive clinical evaluations including cardiac function tests at baseline and 3 months * Learn practical skills including daily weight monitoring, sodium restriction, fluid management, and diuretic self-adjustment * Receive telephone follow-ups weekly in month 1 and biweekly in month 2, with an outpatient visit at month 3

The aim is to explore the reasons for the failure of assisted reproductive technology (ART) in infertile patients in Hunan Province and seek ways to improve the success rate of ART. The study will focus on how environmental exposure (such as environmental pollutants related to plastic products) and lifestyle and social factors affect the success rate of ART in infertile patients. In order to explore these issues in depth, the study plans to collect 5,000 samples (male: female ratio 1:1), screen the research subjects from infertile patients who visited Xiangya Third Hospital in Changsha, Hunan Province, and establish a large-scale, prospective infertility patient cohort. By collecting multi-faceted information of the research subjects, including sociodemographic characteristics, lifestyle, basic health status, etc., and conducting long-term follow-up observations, the ART live birth situation of infertile patients is analyzed. In terms of research methods, a multivariate analysis method will be used to explore the association between various factors and ART success rate, and a risk prediction model will be constructed. In addition, the study also hopes to clarify the specific reasons for the failure of infertile patients to receive ART, provide a scientific basis for clinical decision-making, and provide guidance for the formulation of environmental protection policies and the improvement of public reproductive health literacy. In general, this study, through a large-scale, prospective cohort study, deeply explores the various factors that affect the success rate of ART in infertile patients, and strives to build a risk prediction model in order to improve the success rate of ART and bring more hope to infertile families.

The goal of this clinical trial is to compare the efficacy and safety of induction Benmelstobart plus Anlotinib and chemotherapy followed by concurrent chemoradiotherapy (CCRT) and subsequent Benmelstobart maintenance versus CCRT followed by Benmelstobart maintenance in patients with unresectable stage III NSCLC. Additionally, high-throughput sequencing and multi-omics analysis will be performed on patient-derived tissue and blood samples. By integrating baseline characteristics with clinical data, we aim to identify key determinants of treatment efficacy and prognosis, thereby establishing a precision evaluation system for therapeutic outcomes.

To evaluate the effect of uterine stents in preventing intrauterine adhesions after intrauterine operation and whether they meet the safety requirements for clinical use. The trial adopted a prospective, multicenter, randomized controlled, non-inferiority clinical trial design. The target population of the trial was 200 women aged 20-40 years with intrauterine adhesions and surgical indications (referring to those with fertility requirements or menstrual blood drainage obstruction), who were randomly divided into an experimental group and a control group, with 100 cases in each group. The experimental group was the group with intrauterine stents placed in the uterine cavity after hysteroscopic intrauterine adhesion separation surgery, and the control group was the group with intrauterine rings + balloons + sodium hyaluronate gel placed in the uterine cavity. After 3 courses of artificial cycles, the patients were hospitalized for hysteroscopy review.

This study aims to evaluate the impact of hysteroscopic transcervical resection of the septum (TCRS) on fertility in infertile women without recurrent miscarriage, primarily assessing its effect on subsequent IVF-ET outcomes. The research attempts to answer: for infertile women with uterine septum planning to undergo IVF/ICSI (excluding preimplantation genetic diagnosis), does TCRS improve pregnancy outcomes (such as live birth rate, pregnancy rate, miscarriage rate, etc.) compared to non-surgical treatment (conservative observation), and to clarify the clinical value and safety of this surgical intervention.

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease characterized by the degeneration of motor neurons, leading to progressive muscle weakness and functional decline. This study is designed as a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of an oral preparation of C. cicadae in patients with sporadic ALS and elevated plasma sphingolipid (SL) levels. Efficacy will be assessed primarily by changes in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) score and plasma SL levels.Participants who meet the eligibility criteria and provide written informed consent will be randomly assigned in a 1:1 ratio to either the C. cicadae treatment group or the placebo group. The treatment group will receive oral C. cicadae at a dose of 0.1 g/kg/day (dry weight), administered in three divided doses per day. The placebo group will receive a matched placebo with a similar appearance and odor, administered according to the same schedule. A total of approximately 84 participants will be enrolled. The intervention period will be 6 months, and participants will be followed for a total of 9 months.

The goal of this clinical trial is to: 1\) evaluate the feasibility of conducting decentralized clinical trials (DCT) in collaboration with community resources; 2) test the reliability of a self-developed Digital Platform for Decentralized Clinical Trials (DP-DCT); and 3) compare the effect of two different glucose monitoring methods on glycemic control in patients with type 2 diabetes mellitus (T2DM). The study population consists of adults with T2DM who do not have acute diabetic complications. The main questions it aims to answer are: Is it feasible to conduct a DCT in collaboration with community settings across key steps such as participant recruitment, informed consent, drug delivery, and remote monitoring? Can the DP-DCT platform reliably achieve full electronic integration from participant recruitment to statistical reporting, and automatically generate verified electronic copies of key source data in real time? In patients taking dapagliflozin, does continuous glucose monitoring (CGM) lead to a higher rate of glycemic control target achievement compared to traditional self-monitoring of blood glucose (SMBG)? Researchers will compare the CGM group (dapagliflozin + CGM) and the SMBG group (dapagliflozin + SMBG) to see if there is a difference in the rate of achieving glycemic control targets after 12 weeks of treatment. Participants will: Wear a blinded CGM device for 7days before starting treatment (run-in period) to assess eligibility for randomization. Take dapagliflozin (10 mg once daily) and maintain healthy lifestyle habits. Monitor their blood glucose using either a CGM device or a traditional glucose meter according to their group assignment. Wear a smart bracelet and use a smart weight scale, with all data automatically uploaded via the DP-DCT platform. Wear a blinded CGM device again for 7 days after the 12-week treatment period (follow-up period). Complete most study procedures (including informed consent, drug receipt, and follow-up communication) through an online platform without frequent hospital visits, with some tasks supported by community hospitals.

At present, there is no unified standard for the treatment of missed abortion in clinical practice. This study intends to collect clinical data of this type of disease to compare the efficacy of different treatments, and on this basis, presuppose the synergistic effect of different doses of estrogen in the process of drug induction, conduct statistical analysis of the efficacy, evaluate whether the treatment plan can achieve the therapeutic effect while reducing the occurrence of complications, and provide an effective basis for the subsequent clinical treatment of missed abortion. This study is divided into two parts. The first part is a retrospective analysis to explore the differences between missed abortion surgery and drug treatment, clinical efficacy and reproductive outcomes; the second part is a prospective study to explore the effects of different doses of estrogen combined with surgery or drug abortion on the efficacy of missed abortion in early pregnancy, and explore the best clinical treatment method for missed abortion.

This research plan aims to explore a new diagnosis and treatment management model for intrauterine adhesions and verify its efficacy and feasibility through a multicenter real-world study. Intrauterine adhesions are a common gynecological disease that may affect women's fertility. The study will focus on several key issues: 1. How do three-dimensional ultrasound image features reflect the diagnosis and prognosis of intrauterine adhesions; 2. The effect of new diagnostic and treatment technologies (such as cold knife plowing technology and patented intrauterine stents) in preventing the recurrence of intrauterine adhesions 3. The efficacy of traditional Chinese medicine prescriptions in promoting endometrial growth and preserving pregnancy; 4. How to construct a postoperative infertility risk prediction model that combines multidimensional risk factors of traditional Chinese and Western medicine. To achieve these goals, the study will: 1. Establish four-dimensional ultrasound diagnostic evaluation standards to improve the accuracy of diagnosis; 2. Build a large database and data cohort, standardize the diagnosis and treatment standards, and provide solid data support for the research; 3. Evaluate the efficacy of the new model through real-world research, and compare the clinical efficacy of the new diagnosis and treatment model with the traditional diagnosis and treatment model; 4. Construct and verify the postoperative infertility risk prediction model to provide clinicians with a visual display of risk prediction for clinical application. This study is expected to provide a scientific basis for improving the treatment effect of intrauterine adhesions and reducing the infertility rate, and promote the standardization and standardization of the diagnosis and treatment model of combining traditional Chinese and Western medicine, bringing good news to more patients with intrauterine adhesions.

The purpose of this study is to explore the optimal treatment strategy for retained products of pregnancy. Compared with surgical treatment, prospectively observe whether drug-assisted expectant management until the right time for surgery reduce the occurrence of intrauterine adhesions, and thus protect fertility.

This large-scale study aims to understand how everyday environment and lifestyle may affect the success of fertility treatments like IVF. The main idea is that exposure to certain environmental chemicals (e.g., from plastics or air pollution) and personal habits (e.g., diet, stress) could be linked to whether these treatments result in a successful pregnancy and live birth. The study will follow approximately 5,000 couples undergoing fertility treatment in Hunan, China. Participants will answer questionnaires about their health, lifestyle, and environment and provide small biological samples (like blood and urine) during their standard treatment process. Their treatment outcomes will be tracked anonymously.The goal is to identify factors that might lower the chances of treatment success. This knowledge could help future patients and doctors make informed decisions and could guide public health advice on reducing potential risks. The study has received ethical approval, and all participant information will be kept strictly confidential.

The goal of this clinical trial is to explore the clinical efficacy and safety of individualized antihypertensive medication guided by hemodynamic phenotyping. The main questions it aims to answer are: 1. Does hemodynamics-based individualized antihypertensive therapy achieve better blood pressure control compared to guideline-based conventional therapy? 2. Does hemodynamics-based individualized therapy have comparable safety to guideline-based conventional treatment? Researchers will compare hemodynamics-based individualized antihypertensive therapy to guideline-based conventional treatment to see if the former is better than the latter. Participants will: 1. Take hemodynamics-based individualized antihypertensive therapy or guideline-based conventional treatment every day for 8 weeks 2. Visit the clinic once every 4 weeks for checkups and tests 3. Keep a diary of their symptoms and any treatment