Clinical trials

This multicenter, randomized, prospective, open-label, controlled trial will evaluate the efficacy and safety of oral pregabalin as an adjunct to standard conservative treatment in women with chronic pelvic pain (CPP). Approximately 308 women aged 18 to 65 years with moderate to severe CPP lasting more than 6 months will be enrolled and randomly assigned in a 1:1 ratio to either standard conservative treatment alone or standard conservative treatment plus oral pregabalin. Standard conservative treatment will follow a biopsychosocial management approach and may include patient education, body awareness therapy, cognitive interventions, and individualized conservative care. Participants assigned to the pregabalin group will receive oral pregabalin beginning at 150 mg/day in two divided doses. The dose may be gradually increased according to pain relief and tolerability, up to a maximum of 600 mg/day, and maintained for 12 weeks. The primary outcome is the change in mean pain intensity from baseline to Week 12, measured using a visual analogue scale (VAS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable). Secondary outcomes include pain intensity at Weeks 2, 4, 8, and 12; pregabalin dosage; overall treatment satisfaction; health-related quality of life assessed using the Short Form-12 questionnaire; gynecologic pain assessed using the McCormack scale; and adverse events throughout the study. The total follow-up period is 12 weeks, with assessments conducted at Weeks 2, 4, 8, and 12. Because of the open-label design, participants and treating physicians will know the treatment assignment. Outcome assessors and statisticians will be blinded to treatment allocation. The study will determine whether adding pregabalin to standard conservative treatment improves pain and related patient-reported outcomes while maintaining an acceptable safety profile in women with CPP.

Chronic musculoskeletal pain (CMP) is a common disease in China, with a high incidence among the elderly, and has a significant impact on patients' quality of life. Knee osteoarthritis is a common type of CMP. Currently, both domestic and international studies have confirmed that glucocorticoid injection at myofascial trigger points(MTrPs) can alleviate patients' pain symptoms. MTrPs injection is safe and easy to operate, and can improve the clinical management efficiency of patients with knee osteoarthritis. Therefore, we designed a prospective, randomized controlled, blinded outcome, non-inferiority study to compare the long-term clinical efficacy of glucocorticoid injection at myofascial trigger points and complex intra-articular injection in treating knee osteoarthritis. Patients will be randomly divided into two groups and receive either glucocorticoid injection at MTrPs or joint cavities. After treatment, patients will be followed up for 2 years. Their NRS scores, WOMAC scores, Patient Global Impression of Change(PGIC) scale, and adverse reactions will be recorded at 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 24 weeks. If the results indicate that the clinical efficacy of myofascial trigger point injection for knee osteoarthritis is not inferior to that of injection at intra-articular injection, it will provide a safe and simple treatment option that is easy to promote for patients who do not respond to conservative treatment.

The research team is conducting a randomized, double-blind, placebo-controlled, multicenter clinical study aimed at evaluating the impact of adding Tolecilimab (a PCSK9 inhibitor) to standard lipid-lowering therapy (statins ± ezetimibe) on serum lipoprotein(a) \[Lp(a)\] levels and the risk of stroke recurrence within 90 days in patients with ischemic stroke or high-risk TIA (ABCD² ≥ 4) accompanied by elevated lipoprotein(a) levels (≥30 mg/dL).

This multicenter cohort study is based on the National Brain Tumor Registry of China (NBTRC). It will compare patients who underwent surgery for Pituitary Neuroendocrine Tumors (PitNETs) detected through health screening versus those diagnosed via outpatient consultations. The study will evaluate differences between the two groups in surgical metrics, patient-centered outcomes, and healthcare utilization.

Cerebral hemorrhage, as a serious cerebrovascular disease, has the highest disability rate and mortality rate among all types of cerebrovascular diseases .It has brought a heavy burden to society. In China, the incidence of cerebral hemorrhage is much higher than that in Europe and America, and cerebral amyloid angiopathy (CAA) is one of the causes of primary cerebral hemorrhage However, there are relatively few related studies. Therefore, the research object of this subject focuses on patients with cerebral amyloid angiopathy, in view of their high recurrence rate of vascular events and the lack of treatment methods.It aims to deeply explore the detoxification and blood stasis removal treatment plan combining traditional Chinese and Western medicine to reduce vascular events for patients.

DR.BEYOND-2 is an investigator-initiated, prospective, multicenter, randomized, open-label, blinded-endpoint, parallel-group clinical trial designed to evaluate the efficacy and safety of drug-coated balloon (DCB) angioplasty plus aggressive medical management compared with aggressive medical management alone in patients with high-risk symptomatic intracranial atherosclerotic stenosis (sICAS). A total of 570 eligible patients will be randomized in a 1:1 ratio to the DCB group or the medical management group. Patients assigned to the DCB group will undergo DCB angioplasty in addition to aggressive medical management, with rescue stenting permitted when clinically necessary according to the study protocol. Patients assigned to the control group will receive aggressive medical management alone. The primary endpoint is the composite of any stroke or death within 30 days after enrollment and ischemic stroke in the territory of the qualifying artery from day 31 through 1 year. Participants will be followed for up to 3 years to further evaluate recurrent ischemic events, vascular outcomes, functional outcomes, and long-term safety.

Cerebral vasospasm is a common and serious complication after aneurysmal subarachnoid hemorrhage and is an important cause of delayed cerebral ischemia and poor neurological outcomes. Although standardized medical management is widely used, effective treatment options for cerebral vasospasm remain limited. Endovascular treatment, including intra-arterial drug infusion and mechanical angioplasty, may relieve vasospasm and improve cerebral perfusion after aneurysmal subarachnoid hemorrhage. However, most available evidence comes from retrospective or observational studies, and high-quality randomized evidence remains insufficient. Milrinone is a phosphodiesterase inhibitor with multiple potentially beneficial effects, including vasodilation, positive inotropic activity, anti-inflammatory properties, and endothelial protection. These effects may make milrinone a promising therapeutic agent for relieving cerebral vasospasm, reducing delayed cerebral ischemia, and ultimately improving clinical outcomes after aneurysmal subarachnoid hemorrhage. This study is a multicenter, prospective, randomized controlled clinical trial designed to evaluate whether early continuous milrinone-based endovascular therapy improves outcomes in patients with cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Eligible participants will be randomly assigned to receive either standardized medical management alone or milrinone-based endovascular therapy plus standardized medical management. In the intervention group, patients will receive intra-arterial milrinone during endovascular treatment, with mechanical angioplasty when clinically indicated, followed by continuous intravenous milrinone infusion for 72 hours after intra-arterial administration. The study will evaluate whether this continuous treatment strategy reduces poor neurological outcomes at 3 months after randomization. It will also assess the effects of treatment on delayed cerebral ischemia, vasospasm resolution, cognitive function, quality of life and so on. The results of this trial may provide high-quality evidence for early continuous milrinone-based endovascular therapy as a treatment strategy for cerebral vasospasm after aneurysmal subarachnoid hemorrhage.

The goal of this clinical trial is to learn if acupuncture based on the "Form-Qi-Spirit" theory works to treat post-traumatic olfactory dysfunction in adults. It will also learn about the safety of this acupuncture treatment. The main questions it aims to answer are: Is the efficacy of 4-week acupuncture treatment superior to 4-week steroid treatment for post-traumatic olfactory dysfunction? What medical problems or side effects do participants have when receiving acupuncture? Researchers will compare real acupuncture plus a placebo (a look-alike pill with no active drug) to sham acupuncture (non-penetrating placebo needles) plus low-dose oral steroids (prednisone) - to see if the real acupuncture strategy works better than the steroid strategy for post-traumatic olfactory dysfunction. Participants will: Receive real acupuncture + placebo pills, OR sham acupuncture + low-dose prednisone, for 4 weeks Undergo acupuncture/sham sessions 3 times per week (12 sessions in total) Take the assigned pills daily (with tapering doses over 4 weeks) Visit the clinic for smell tests, psychological assessments, and safety checks at baseline, at 4 weeks (end of treatment), and at 12 weeks (8 weeks after treatment ends) Let me know if you need a more detailed version or any adjustments.

This multicenter, prospective, randomized, open-label, wait-list controlled trial will evaluate the efficacy and safety of bilateral electroconvulsive therapy (ECT) for adults with refractory fibromyalgia (FM). Participants will be recruited from Beijing Tiantan Hospital and Beijing Jianjia Rehabilitation Hospital. Eligible participants will have FM diagnosed according to the 2010 American College of Rheumatology criteria, will have received stable standard medical treatment including at least two combined pharmacological treatments during the previous 3 months, and will have substantial disease-related functional impairment as indicated by a Revised Fibromyalgia Impact Questionnaire (FIQR) score of 39 or higher. Concomitant medications will remain at stable doses during the study whenever possible. Participants will be randomized to an immediate ECT group or a wait-list control group. Participants in the immediate group will receive bilateral ECT in addition to their usual standard treatment. ECT will be administered under general anesthesia using a standardized bilateral electrode placement and individualized stimulus dosing, with 1 to 2 treatment sessions per week for a total of 6 sessions over 4 weeks. Participants in the wait-list group will continue usual standard treatment during the initial randomized control period and will subsequently be offered the same 4-week ECT course. The primary outcome is the change in average pain intensity, measured using the 0-10 Numeric Rating Scale (NRS), from baseline to 1 month after completion of the initial 4-week treatment or control period. Secondary outcomes include pain intensity, FM-related functional impairment, sleep quality, depressive symptoms, health-related quality of life, patient-reported global improvement, cognitive function, memory complaints, postictal confusion, and adverse events. Follow-up assessments will continue for 3 months after ECT or the corresponding control period. Outcome assessors and statisticians will be blinded to treatment allocation.

Video-assisted thoracoscopic surgery (VATS) is less invasive compared to traditional thoracotomy, but it is still reported that the incidence of acute pain following VATS exceeds 80%. Inadequate postoperative analgesia may trigger a series of adverse physiological stress responses, increase the occurrence of postoperative complications, and affect the rehabilitation process. If acute pain is not managed promptly and sufficiently, nearly one-quarter of patients may develop chronic pain, impacting normal life and sleep quality after discharge. Acute pain after VATS is mainly caused by the release of inflammatory mediators after soft tissue injury at the surgical site, which activates peripheral pain receptors and leads to abnormal action potentials transmitted along A δ and C fibers. Inflammatory mediators released from the soft tissues around incisions not only significantly alters the chemical microenvironment at the peripheral terminals of nociceptors, directly inducing pain, but also sensitizes afferent fibers, contributing to peripheral sensitization. Incisional infiltration is the simplest, safest, and most effective anesthesia method for preventing incision pain after laparoscopic surgery but even using long-acting local anesthetics, the effectiveness of postoperative analgesia can only last for a relatively short period of time. To improve the efficiency of local incision infiltration in postoperative analgesia, at least two issues need to be addressed: prolonging the duration of analgesia and reducing inflammation of nerve surrounding tissues. Numerous studies have shown that glucocorticoids not only can achieve anti-inflammatory and analgesic effects by inhibiting inflammatory cytokines and inflammatory responses but also can prolong the duration of action of local anesthetics. The investigators conducted a multicenter, prospective, randomized controlled clinical study to explore whether preemptive incisional infiltration with ropivacaine plus triamcinolone is superior to ropivacaine alone in relieving postoperative pain for adults undergoing VATS. The investigators also compare the effects of the two intervention measures on postoperative pain management, patient safety, and recovery quality.

The goal of this clinical trial is to evaluate the safety and effectiveness of Efgartigimod in patients with Guillain-Barre syndrome (GBS). The main questions it aims to answer are: Is Efgartigimod a safe treatment option for GBS patients? Does treatment with Efgartigimod improve patient outcomes? Participants will: Take drug Efgartigimod or Intravenous Immunoglobulin during hospitalization Undergo six blood draws in six follow-up study visits to evaluate the concentration of IgG Keep a diary of their symptoms and drugs using at the same time

Intracranial aneurysm, as a common cerebrovascular disease, has a variety of treatment methods, including surgical treatment and endovascular treatment. Among these treatment methods, flow diverters have attracted much attention due to their unique therapeutic principles. Flow diverters help promote thrombus formation within the aneurysm by altering the direction and dynamics of blood flow, thereby achieving the purpose of treatment. 1-5 Flow diverters such as the Pipeline™ device have been proven to be safe and effective for the treatment of intracranial aneurysms and have gradually been recognized as the preferred device for the management of intracranial aneurysms.

Postoperative delirium and postoperative ischemic stroke are common neurological complications in clinical practice. The incidence of these complications is further increased in patients undergoing neurosurgical procedures. Intraoperative hypotension and burst suppression are high-risk factors for postoperative delirium and ischemic stroke. Ciprofol, as a new intravenous general anesthetic, can significantly reduce the occurrence of hypotension and decrease burst suppression compared with propofol. However, no study has demonstrated that the application of ciprofol in neurosurgical patients can improve patient prognosis. Therefore, the purpose of this study is to explore the impact of using ciprofol or propofol in anesthesia induction and maintenance on postoperative neurological complications in patients with high intracranial pressure.

This is a single-arm, open-label, single center, dose-escalation exploratory clinical study to evaluate the safety and tolerability of a single intracerebral injection of NXL-001, a NeuroD1 base gene therapy, in patients with chronic neuronal deficits from ischemic stroke.

Video-assisted thoracoscopic surgery (VATS) is the mainstream minimally invasive procedure in thoracic surgery; However, the high-stress state during the perioperative period and severe postoperative pain often lead to significant disruption of patients' sleep patterns, thereby exacerbating postoperative pain sensitisation and delaying early recovery. Traditional sleep-inducing drugs, primarily benzodiazepines, have significant limitations in the perioperative period of thoracic surgery, including respiratory depression, dizziness and residual central effects, which hinder early ambulation. As a new-generation dual orexin receptor antagonist, Lemborexant exerts its sleep-promoting and anti-stress effects by precisely blocking excessive arousal pathways. Furthermore, it causes no respiratory depression, no hangover-like effects the following day, and does not impair muscle strength or mucus clearance, offering the potential to meet the dual requirements of sleep quality and high safety in Enhanced Recovery After Surgery (ERAS) protocols for thoracic surgery. However, there remains a lack of prospective clinical evidence regarding its application in the high-stress, high-pain perioperative acute cohort of thoracoscopic surgery. This study aims to conduct a prospective, randomised, double-blind, placebo-controlled clinical trial to improve perioperative sleep quality in VATS patients. The primary outcome measure of the study was the difference in the incidence of perioperative sleep disorders (PSD) between the two groups, as assessed by the total Richards-Campbell Sleep Questionnaire (RCSQ) score on the night of surgery. The study aims to investigate the causal relationship between short-term perioperative Lemborexant intervention and improvements in patient sleep and postoperative recovery quality. The anticipated results will provide clinical evidence of the safety and efficacy of Lemborexant for use in high-stress populations during the perioperative period.

The goal of this clinical trial is to learn whether adding mirogabalin to educational-behavioral modification program (EBMP) improves symptoms and safety outcomes for adults living with interstitial cystitis/bladder pain syndrome (IC/BPS). The main questions this study aims to answer are: 1. Does combined mirogabalin and EBMP treatment produce better overall symptom improvement after 12 weeks compared with EBMP alone? 2. Is combination treatment safe and well-tolerated in adults with IC/BPS? Researchers will compare two treatment groups to test these questions. Eligible adult participants will be randomly assigned in a 1-to-1 ratio to one of two groups. Randomization is performed through a certified online clinical trial platform with allocation concealment. Participants will: * Receive either standard EBMP alone or EBMP plus oral mirogabalin for 12 weeks * Follow a flexible mirogabalin dosing schedule in the combination group, starting at a low dose and gradually increasing based on individual tolerance * Complete regular clinic visits, bladder diaries, and symptom questionnaires at baseline, week 2, week 6, and week 12 * Undergo repeated assessments of pain, bladder function, quality of life, sleep status, and mood during treatment This is an open-label study, meaning participants and treating clinicians know the assigned treatment. To avoid assessment bias, outcome evaluators remain blinded to group allocation throughout the trial. The primary study outcome is participants' overall symptom response after 12 weeks of treatment. Secondary outcomes include changes in bladder pain, urinary frequency, functional bladder capacity, IC/BPS-specific symptoms, quality of life, sleep quality, and depressive symptoms. The study also monitors all adverse events to evaluate treatment safety over 12 weeks.

Postherpetic neuralgia (PHN) is the most common complication of herpes zoster (HZ) and represents a major clinical challenge due to its chronicity and impact on quality of life. Current treatments for acute HZ pain have limited efficacy in preventing PHN, highlighting the need for effective preventive strategies targeting early pathophysiological mechanisms. Venlafaxine as a plausible and clinically relevant candidate for early intervention to prevent the transition from acute HZ pain to PHN.

This randomized clinical trial aims to evaluate the effect of preoperative use of dexmedetomidine nasal spray on improving perioperative anxiety levels in patients undergoing elective supratentorial tumor resection.

Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common. Selective serotonin and norepinephrine reuptake inhibitors (SNRIs), such as duloxetine, has demonstrated efficacy in FM by modulating pain pathways through increased serotonin and norepinephrine availability. Several studies have highlighted benefits of venlafaxine in FM. We hypothesize that the combination of pregabalin with venlafaxine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.

Postoperative delirium is a common acute central nervous system syndrome, which often occurs 1-5 days after surgery. Postoperative delirium can prolong the length of hospital stay, increase the mortality rate, and is also associated with long-term postoperative cognitive dysfunction. However, the pathogenesis of postoperative delirium in elderly patients undergoing neurosurgical procedures, who are at high risk for ostoperative delirium, remains unclear. This study aims to elucidate the underlying mechanisms of postoperative delirium in this population and inform the development of effective prevention and treatment strategies.

To explore the efficacy of a single low dose of esketamine for patients with irritable bowel syndrome (IBS).

To compare the dosage requirement of intravenous anesthetics during digestive endoscopy between patients with insomnia and those with normal sleep pattern.

This is a randomized, prospective, multicenter, open-label, blinded-endpoint study investigating the efficacy and safety of dexamethasone palmitate (DXP) for treating acute and subacute herpes zoster (shingles) pain. The study consists of four parallel sub-studies, each designed to answer a specific question: Study 1: Compares intramuscular (IM) vs. intravenous (IV) administration of DXP (8mg) against standard therapy alone. Study 2: Compares two different IV doses of DXP (4mg vs. 8mg) against standard therapy. Study 3: For HZ on the body trunk, compares IM injection vs. tender point infiltration vs. paravertebral nerve block (all containing 8mg DXP). Study 4: For HZ on the face (trigeminal nerve), compares IM injection vs. tender point infiltration vs. trigeminal nerve block (all containing 8mg DXP). Approximately 558 adult patients with HZ rash onset within 90 days and significant pain (VAS ≥7) will be enrolled across the studies. All patients receive standard background therapy, including antiviral medication (famciclovir), pregabalin, and rescue analgesics. The primary outcome is the change in pain intensity (Visual Analogue Scale, VAS) over 6 months. Secondary outcomes include the incidence of postherpetic neuralgia (PHN) at 3 and 6 months, consumption of pain medications, patient satisfaction, quality of life, and safety. The goal is to determine if DXP, through its targeted anti-inflammatory action, provides superior pain relief and PHN prevention compared to standard care, with a favorable safety profile across different administration routes.

Postoperative pain remains highly prevalent and inadequately managed in a significant proportion of surgical patients, often leading to delayed recovery, increased opioid consumption, and potential progression to chronic pain. While perioperative systemic dexamethasone is used for its anti-inflammatory and opioid-sparing effects, its efficacy is inconsistent, and concerns regarding systemic side effects persist. Dexamethasone palmitate, a novel lipophilic prodrug formulated as nanoparticle emulsion, leverages the enhanced permeability and retention effect to target inflammatory sites selectively, potentially offering superior anti-inflammatory and analgesic efficacy with reduced systemic exposure. This trial aims to evaluate whether preoperative intravenous dexamethasone palmitate is more effective than conventional dexamethasone in preventing moderate-to-severe postoperative pain.

This Phase 2b study will evaluate whether lesion network mapping-guided continuous theta burst stimulation (cTBS) can improve recovery after acute ischemic stroke. The treatment uses each participant's brain imaging to identify individualized stimulation targets related to stroke symptoms. Participants will receive either active cTBS or a sham procedure in addition to standard stroke care. The study will assess the efficacy and safety of this personalized brain stimulation approach and support planning for future confirmatory trials.