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Found 9 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating AK112, a PD-1VEGF bispecific antibody, as a consolidation treatment for patients with limited stage small cell lung cancer who have not shown disease progression after concurrent chemoradiation therapy. This phase III, randomized, double-blind study aims to compare the effectiveness and safety of AK112 against a placebo in this specific patient group. Participants will receive either AK112 or a placebo intravenously every three weeks as consolidation therapy following their initial chemoradiation. The study includes two groups one receiving AK112 at a dose of 20 mgkg every three weeks, and the other receiving a matching placebo on the same schedule. Treatment continues under close monitoring to assess outcomes. Throughout the study, participants will undergo regular assessments including scans and evaluations to monitor progression-free survival and overall survival over approximately six years. Additional outcome measures include response rates and disease control rates assessed by both independent review and investigators, along with safety monitoring for adverse events. This long-term follow-up helps researchers understand how the treatments perform and their impact on patient health.

Age: 18Years +All GendersPhase 3
53 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of the AGENT Drug-Coated Balloon AGENT DCB compared to the standard care involving drug eluting stent DES andor balloon angioplasty in patients with new de novo coronary artery lesions. The study is prospective, multicenter, open-label, and randomized. It includes a pharmacokinetic PK sub-study and an intravascular ultrasound IVUS sub-study to gather additional data. Participants are assigned to one of several groups based on lesion types such as small vessels, bifurcation side branches, and long lesions. They receive either the AGENT DCB or standard care treatments including drug eluting stents or plain old balloon angioplasty POBA. The study compares these treatments in parallel groups according to the specific lesion characteristics. During the study, participants undergo the assigned procedure followed by protocol-required evaluations and follow-up visits to monitor outcomes. Researchers will assess the primary outcome of target lesion failure rate at 12 months. Participants are monitored for safety and effectiveness, with ongoing assessments throughout the study duration which continues until March 2032.

Age: 18Years +All GendersPhase Not Applicable
67 locations
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Actively Recruiting

Researchers are evaluating the effectiveness of combining anlotinib hydrochloride capsules with penpulimab injection as an additional treatment after radical surgery or ablation for patients with hepatocellular carcinoma HCC who are at high risk of cancer returning. This Phase 3 randomized, double-blind, placebo-controlled study aims to compare this combination therapy to a placebo to assess recurrence-free survival RFS over a period of up to three years. Participants receive either the anlotinib capsules plus penpulimab injection or matching placebos in 21-day treatment cycles. The study groups include an experimental arm receiving both active drugs and a control arm receiving placebo capsules and injections. This approach helps researchers understand how well the combination works in preventing cancer recurrence after initial treatment. Throughout the study, participants will have their health monitored regularly, including assessments of recurrence-free survival, time to cancer recurrence, time to spread outside the liver or vascular invasion, overall survival, and response rate after any recurrence. These evaluations will occur from the start of the study and continue for up to three years to track long-term outcomes and safety.

Age: 18Years - 75YearsAll GendersPhase 3
67 locations
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Actively Recruiting

Researchers are studying TQC2731 injection, a humanized monoclonal antibody that targets Thymic Stromal Lymphopoietin TSLP to block its pathway and reduce inflammation. This clinical trial focuses on patients with chronic rhinosinusitis with nasal polyps CRSwNP to evaluate the safety and effectiveness of TQC2731 injection. Participants will receive either TQC2731 injection or a placebo in treatment cycles lasting 4 weeks. The study is randomized, double-blind, and placebo-controlled, with repeated treatment cycles. The effects on nasal polyp size and nasal congestion will be assessed over a 24-week period, with additional measures taken up to 60 weeks. During the trial, participants will undergo nasal endoscopy to score nasal polyps and congestion, complete symptom questionnaires, and have blood and nasal tissue samples collected at various points. Safety monitoring includes tracking adverse events and immune response tests. The study duration extends to 60 weeks to evaluate long-term outcomes and treatment impact.

Age: 18Years - 75YearsAll GendersPhase 3
60 locations
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Actively Recruiting

Bladder cancer is a common urinary system cancer, with 70-80% being nonmuscle invasive types treated primarily by transurethral resection of bladder tumor TURBT. This study evaluates the effects of remimazolam, a new benzodiazepine with rapid onset and short action, on emergency delirium and cancer recurrence after bladder cancer surgery. Researchers are interested in comparing remimazolam to propofol anesthesia and understanding its impact on postoperative delirium and long-term cancer outcomes. Participants are randomly assigned to receive either remimazolam or propofol intravenously for anesthesia induction and maintenance during bladder tumor surgery. The anesthesia dose is adjusted to maintain a specific brain activity level Bispectral Index between 40 and 60. Pain relief and muscle relaxation are provided with other medications, and inhaled sevoflurane may be given if needed. Both groups receive similar supportive drugs to manage pain and muscle relaxation. During the study, patients are closely monitored for early emergence delirium within 2 hours post-surgery and for recurrence-free survival up to 3 years. Other outcomes include postoperative delirium, nausea, awareness during surgery, hospital stay length, complications, and survival rates. Assessments include clinical evaluations in the recovery unit and follow-up visits over several years to measure cancer recurrence and quality of life.

Age: 50Years - 90YearsAll GendersPhase 4
6 locations
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Actively Recruiting

Researchers are evaluating and comparing the effects of total intravenous anesthesia using remimazolam versus propofol in patients at moderate to high risk undergoing major elective noncardiac surgery under general anesthesia. This randomized controlled trial aims to determine if remimazolam can increase the number of days patients are alive and out of the hospital within 30 days after surgery. The study is conducted by Nanfang Hospital, Southern Medical University and is classified as a phase 4 trial. Participants receive either remimazolam or propofol as anesthesia. Remimazolam is given intravenously at 6-12 mgkgh for induction and 1.0-2.0 mgkgh for maintenance, adjusted to keep the Bispectral Index between 40 and 60. Propofol is administered intravenously at 1.5-2.5 mgkg for induction and 4-12 mgkgh for maintenance, also titrated to maintain the same Bispectral Index range. These dosing strategies help monitor and control anesthesia depth during surgery. During the study, participants will be closely monitored for outcomes including days alive and out of hospital at 30 days after randomization, all-cause mortality within 30 days, length of hospital stay, unplanned re-hospitalizations, postoperative complications, and quality of recovery on the first day after surgery. The trial involves double-blind randomization and includes follow-up assessments at 30 days to gather comprehensive data on recovery and safety.

Age: 45Years +All GendersPhase 4
44 locations
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Actively Recruiting

Researchers are evaluating the effects of high caloric oral nutritional supplements on growth, development, and related health aspects in malnourished children aged 1 to 3 years. This study aims to assess body proportion, weight, linear growth, neuropsychological development, gut health, immune function, and quality of life, while also evaluating the safety of these supplements. The trial addresses a lack of multicenter clinical data on these supplements in malnourished Chinese children and seeks to provide evidence for clinical intervention strategies. Participants will be randomly assigned to one of two groups the experimental group receiving nutritional education plus daily high caloric oral nutritional supplements that provide 30% of energy needs, and the control group receiving nutritional education and dietary guidance only. The intervention lasts 12 months, with the supplement feeding reviewed at 6 months to decide on continuation. Nutritional education is delivered via WeChat or text messages, and dietary guidance is provided by pediatricians at regular follow-up visits. Throughout the study, participants will be followed at 0, 1, 2, 3, 6, and 12 months. Researchers will collect dietary diaries, physical measurements, developmental tests, quality of life questionnaires, gut health and infectious disease assessments, and laboratory tests including blood, urine, liver, and kidney function. The main outcome measured is the BMI for Age Z-score at 6 months. Safety and efficacy are monitored continuously to understand the impact of the supplement on growth and development in malnourished children.

Age: 1Year - 3YearsAll GendersPhase Not Applicable
13 locations
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Actively Recruiting

Fibromyalgia is a chronic condition marked by widespread pain, fatigue, and emotional challenges. This trial is studying whether combining pregabalin with venlafaxine provides better pain relief than pregabalin alone, as pregabalin alone offers limited relief and may cause side effects. The study is sponsored by Beijing Tiantan Hospital and focuses on improving treatment options for people with moderate to severe fibromyalgia. Participants will be randomly assigned to one of two groups. One group receives pregabalin starting at 150 mg per day, increasing to 300 mg, and possibly up to 450 mg based on response. The other group receives the same pregabalin regimen plus venlafaxine, starting at 75 mg per day and potentially increasing to 225 mg. Treatment lasts up to 12 weeks, with dosing adjusted according to tolerance and clinical response. During the study, participants will undergo pain assessments and complete questionnaires at weeks 1, 2, 4, 8, and 12 to measure pain intensity, impact on daily life, sleep quality, depression symptoms, and overall health. Researchers will monitor medication doses, adverse events, and pain reduction rates. The main outcome is average pain intensity at 4 weeks, with safety and effectiveness tracked throughout the 12-week period.

Age: 18Years +All GendersPhase Not Applicable
2 locations
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Actively Recruiting

Researchers are studying the safety and activity of weekly irinotecan liposome injections in patients with relapsed and metastatic Ewing Sarcoma, a condition with poor prognosis after standard therapy. This phase 1 dose-finding study uses a Bayesian Optimal Interval design to explore treatment in patients who have failed first-line chemotherapy including doxorubicin, vincristine, cyclophosphamide, ifosfamide, and etoposide. Participants receive Irinotecan Hydrochloride Liposome Injection weekly, with 5 doses administered every 6 weeks. This liposomal form may stay longer in the body and offers a more convenient weekly schedule compared to traditional irinotecan infusion. Both pediatric and adult patients are included, with treatment tailored to their condition and monitored closely. During the study, participants undergo regular assessments including CT or MRI scans to measure tumor response by RECIST 1.1 criteria. Researchers will monitor the maximum tolerated dose over 6 weeks and track response rates and progression-free survival up to 24 months. Safety evaluations and organ function tests are conducted throughout, with follow-up visits scheduled to observe treatment effects and tolerability.

Age: 8Years - 40YearsAll GendersPhase 1
3 locations