Jin Hua Shi

This research aims to evaluate whether adding a traditional Chinese medicine called Lingze tablets to the standard drug tamsulosin can better improve sleep quality and reduce nighttime urination problems in men who have undergone transurethral holmium laser enucleation of the prostate, a minimally invasive surgery for enlarged prostate. Many men continue to experience bothersome urinary symptoms and poor sleep after surgery, which can significantly affect their quality of life. This trial compares standard treatment to a combination approach to see if the addition of Lingze tablets offers added benefits. Participants will be randomly assigned to one of two groups. One group will take tamsulosin sustained-release capsules 0.2 mg orally once daily at bedtime for 8 weeks. The other group will take the same tamsulosin dose plus Lingze tablets 4 tablets, three times daily for 8 weeks. Lingze tablets are herbal-based and thought to support kidney function and clear bodily dampness and heat according to traditional Chinese medicine. Both groups will receive standard postoperative care guidance on diet, fluid intake, and activity. During the study, participants will visit the clinic at the start, 4 weeks, and 8 weeks for assessments. They will complete questionnaires on urinary symptoms, sleep quality, anxiety, and quality of life. Non-invasive urine flow tests and bladder ultrasounds will measure urinary function. Medication adherence and any side effects will be monitored. The primary outcome is the change in nighttime urination frequency over 8 weeks, with secondary outcomes including sleep quality and symptom severity. Safety and privacy are carefully maintained throughout the study.

Researchers are evaluating STI-7349, a new drug administered intravenously, in adults with advanced solid tumors who have failed or cannot tolerate standard treatments. This first-in-human Phase 1 study involves dose escalation and expansion phases to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of STI-7349 alone and in combination with Pembrolizumab or other approved PD-1PD-L1 inhibitors like Tislelizumab. The study aims to determine the recommended doses for further research and to evaluate treatment-related side effects over up to two years. The study is divided into two main periods. Period I includes dose escalation and expansion of STI-7349 alone, starting with low doses and gradually increasing following specific schedules over 21 to 28-day cycles with dosing on Day 1 and Day 15. Period II involves dose escalation and expansion of STI-7349 combined with Pembrolizumab or other approved PD-1PD-L1 inhibitors, using doses based on the results from Period I. Participants receive these combinations following similar dosing schedules and may also receive standard treatment alongside the study drugs depending on the stage of their condition. Participants will undergo regular dosing cycles lasting up to two years or until disease progression, unacceptable side effects, or withdrawal. Throughout the study, researchers will monitor safety through treatment-related adverse events, pharmacokinetic profiles including drug concentration levels, and measure tumor response using imaging techniques. Additional assessments include survival rates, disease control, and immune response markers. Participants will complete scheduled visits for drug administration and evaluations, with ongoing safety follow-up to understand the effects of the treatments.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Esophageal squamous cell carcinoma ESCC is a common and deadly cancer in China, with many patients diagnosed at advanced stages. This study evaluates a combined treatment approach using induction immunochemotherapy followed by concurrent chemoradiotherapy, aiming to improve outcomes for patients with locally advanced, unresectable ESCC. Researchers also focus on using circulating tumor DNA ctDNA to monitor treatment response and predict tumor progression, as ctDNA changes can appear before imaging detects recurrence. Participants receive induction immunochemotherapy consisting of toripalimab combined with paclitaxel and cisplatin every three weeks for two cycles. This is followed by radical concurrent chemoradiotherapy with weekly paclitaxel and cisplatin for five cycles along with radiotherapy delivered five days per week. The study dynamically monitors ctDNA levels at several points before treatment, before chemoradiotherapy, after 20 radiotherapy fractions, and every three months after treatment completion. During the study, participants undergo regular assessments including blood tests for ctDNA analysis and monitoring of tumor status. The main outcome measured is progression-free survival at one year. Safety and efficacy are tracked throughout the treatment and follow-up periods. The total participation duration and timing of assessments are carefully planned to evaluate the treatment strategy and its correlation with patient prognosis.

Researchers are evaluating the anti-tumor effects of golidocitinib compared to investigators choice treatments in adults with relapsed or refractory peripheral T-cell lymphoma PTCL. This phase 3, open-label, randomized study includes patients who have confirmed PTCL and have not responded to or tolerated at least one prior systemic therapy. The study focuses on several PTCL subtypes and aims to improve treatment options for this condition. Participants will be randomly assigned to receive either golidocitinib orally once daily in repeated 21-day cycles or one of the investigators choice treatments, which may include chidamide taken orally twice a week or gemcitabine given intravenously on specific days within 28-day cycles. Treatments continue according to protocol with no masking or blinding involved. During the study, participants will be monitored for progression-free survival as the primary outcome, measured from the date of randomization until disease progression or death, over approximately four years. Secondary outcomes like overall survival will also be tracked. Eligibility assessments, compliance with contraceptive requirements, organ function tests, and ongoing safety monitoring will be part of the participant involvement throughout the study duration.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

This research aims to evaluate the effects of royal jelly major proteins MRJPs delivered as rose tablet candies on ovarian function and endometrial receptivity in women aged 20 to 45 with normal menstrual cycles. The study will explore how MRJPs influence female reproductive health, focusing on their role in improving fertility factors such as hormone levels, ovarian reserve, and the uterine linings ability to support embryo implantation. It also seeks to determine the safety and potential clinical value of MRJPs for reproductive medicine. Participants will be randomly assigned to one of two groups one receiving oral MRJPs candy containing 70% MRJPs freeze-dried powder, and the other receiving a placebo candy mainly composed of whey protein powder. Both groups will take one tablet twice daily for one menstrual cycle. The MRJPs candy uses patented technologies to ensure quality and stability of the active ingredients. The placebo group allows comparison to evaluate the specific effects of MRJPs. Throughout the trial, researchers will monitor hormone levels, including anti-Mllerian hormone, and assess endometrial receptivity from enrollment through the one-month treatment period. Various tests and measurements will be conducted to track ovarian function and hormonal changes. The study is conducted with ethical oversight and scientific rigor to protect participants and ensure reliable results, with total participation lasting about one menstrual cycle plus screening and follow-up.

Researchers are evaluating the effectiveness of two treatments, bleomycin injection and cryotherapy, for plantar warts Verruca Plantaris. This randomized controlled trial aims to compare how well these treatments work using dermoscopy, as well as assess their safety, economic impact, and effects on quality of life. The study includes adult participants aged 18 to 65 years with diagnosed plantar warts. Participants are randomly assigned to one of two groups the Bleomycin Group or the Cryotherapy Group. The bleomycin treatment involves injecting a diluted solution directly into the wart based on its size, while the cryotherapy treatment uses liquid nitrogen to freeze the wart twice with a 30-second interval. The effectiveness of each treatment is evaluated two weeks after the treatment ends. During the study, patients will undergo assessments including dermoscopic examination of the warts and photographic documentation of the lesions. Researchers will monitor the complete clearance rate of warts as the primary outcome. Safety and other impacts such as quality of life and cost will also be tracked. The total study duration and specific visit schedules are based on treatment and follow-up timelines ending in mid-2025.

Researchers are evaluating the long-term safety and effectiveness of the NOVA intracranial drug-eluting stent system in patients with intracranial atherosclerotic stenosis. This study is a prospective, multi-center, single-arm clinical trial conducted across about 50 centers in China, aiming to include 1000 participants who are suitable candidates for stent angioplasty. The trial will run from December 2022 to December 2030, focusing on patients with significant artery narrowing in the brain. All participants will receive the NOVA drug-eluting stent, which is designed to treat intracranial artery stenosis with a sirolimus-eluting coating and a rapid exchangeable balloon. The study includes ten visits starting from preoperative screening, the operation day, then follow-ups at 30 days, 3 months, 6 months, 1 year, and annually up to 5 years after the procedure. This schedule allows researchers to closely monitor the devices performance and patient outcomes over time. Participants will undergo various assessments during these visits, including evaluations for stroke, death, ischemic events, and revascularization related to the treated artery. Other measures include rates of stroke in different brain regions, transient ischemic attacks, restenosis, bleeding events, and quality of life assessments using tools like the modified Rankin Scale and EuroQol-5D. Safety, device defects, and long-term outcomes will be carefully tracked throughout the study period, which lasts up to five years after the operation.