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Filter by:This is a multicenter, open, phase II clinical trial to evaluate the safety and efficacy of almonertinib combined with pyrrolitinib in locally advanced or metastatic NSCLC patients with her-2 variants detected after first-line EGFR-TKI treatment resistance. Patients with first-line EGFR-TKI resistance showed HER-2 variation (including mutation and amplification) in tissue or blood tests, and the treatment regimen of metinil combined with pyrrolitinib was performed to evaluate the safety and efficacy of the treatment regimen. To determine the optimal dose of pyrrolitinib, three dose groups of 240mg, 320mg, and 400mg were set, and the "3+3" study design principle was adopted. About 27-36 people will be included in the study (depending on the progress of the study)
This trial is to determine the safety of 4 new probiotic strains and to assess their efficacy in reducing the incidence and/or duration of gastrointestinal problems and infections as well as respiratory infections in healthy adults.
This study aims to investigate the uptake of AP701, a preparation from cannabis flowers, into the bloodstream after in single administration in healthy volunteers.
Clinical phase I, controlled, non comparative, open, single center study evaluating the safety and tolerability of ophthalmic solution PRO-172 when applied on the ocular surface of healthy volunteers.
This is a First in Human (FIH), double-blind, randomised, placebo-controlled study designed to evaluate safety, tolerability and PK of single and multiple ascending oral doses of AM1476 in healthy subjects.
Type of Study: Single Ascending Doses (SAD) Study Objectives: To characterize the pharmacokinetic (PK) profile of JOTROL (resveratrol) following oral administration of SAD ranging from 200 mg up to a dose currently estimated at 1,000 mg, in healthy subjects. To evaluate the safety and tolerability of JOTROL To evaluate the effect of food on the PK profile of JOTROL. Study Design: Phase I, randomized, open-label, sequential SAD study with a food effect evaluation. Blood plasma and urine samples will be assessed for resveratrol and key metabolite content. Type of Control: No control Test Product: JOTROL (resveratrol) 100 mg resveratrol in 1000 mg softgel capsule for oral administration Dosage Regimen: Planned dose levels of resveratrol: 200 mg, 500 mg, and 1,000 mg. Following completion of each dose level, PK, safety, and tolerability data will be evaluated; dose levels may be adjusted. Route of Administration: Oral gelcaps with water Number of Subjects: 24 subjects will be included in Part 1; only 16 subjects, who completed Part 1, will be included in Part 2. Subjects: Healthy, non-smoker, adult males or females, ≥ 18 and ≤ 75 years of age Study Duration: Participation of each subject in this study should last approximately 1 to 1.5 months (for subjects participating in study Part 1 only) and 1.5 to 2 months (for subjects participating in both study parts).
This Phase 1 study is designed to assess the safety and tolerability of single and multiple intravenous (IV) doses of MRX-8, to assess the pharmacokinetics of MRX-8 and its primary metabolite following single and multiple IV doses, and to measure the elimination of MRX-8 and its metabolite in urine.
This study is a longitudinal assessment using a classic dose-escalation study design to assess the safety and maximal tolerated dose (MTD) of locally delivered allogeneic mesenchymal stromal cells (MSC) for promoting corneal repair. The study will be conducted at Illinois Eye and Ear Infirmary located at University of Illinois at Chicago. The study will use digital conjunctival and corneal photography and corneal Scheimpflug Imaging, densitometry, and pachymetry for assessment of safety and corneal wound healing.
Objectives 1. To observe whether sodium bicarbonate Ringer injections can reduce the incidence of postoperative complications in elderly patients undergoing abdominal surgery. 2. To observe the effects of sodium bicarbonate Ringer injections on the internal environment, such as water, electrolytes, acid-base balance, and other physiological indexes, in the perioperative period of elderly patients undergoing abdominal surgery. Research design：This study adopts a multicenter, prospective, randomized, controlled, pragmatic clinical trials (PCT) research design. Sample size：5000 cases. Indication：The experimental group is the elderly patients undergoing abdominal surgery who were administered sodium bicarbonate Ringer injections intraoperatively; the control group is the elderly patients with abdominal surgery who were administered lactated Ringer's injections intraoperatively. Observational index Preoperative baseline data collection: General patient information: basic information (age, height, and weight), preoperative diagnosis, past history, auxiliary examination results, etc. Intraoperative data collection: Perioperative vital signs information and arterial blood gas analysis results; The surgical method, operation time, and anaesthesia time; Intraoperative fluid management: The total amount of intraoperative fluids, blood transfusion volume, bleeding volume, urine volume, types and dosage of vasoactive drugs, diuretic dosage, sodium bicarbonate dosage. Postoperative index: Postoperative blood biochemical examination: liver function, renal function (urea nitrogen, creatinine), osmotic pressure, lactic acid, and blood sugar levels; Postoperative complications and treatment status Postoperative recovery: postoperative outcome, length of hospital stay, admission to ICU (duration of stay), postoperative eating time, out of bed activity time, gastrointestinal recovery time (exhaust), time for removal of various tubes (gastric tube, urinary tube, and drainage tube), etc. The observation cut-off point is the patient's discharge. If the patient is still hospitalized 30 days after the operation, the observation will be terminated. Research process 1. Elderly abdominal surgery patients who meet the inclusion criteria will be enrolled and randomly divided into two groups according to the intraoperative application of extracellular fluid supplements. The experimental group is sodium bicarbonate Ringer injection group, and the control group is sodium lactate Ringer injection. Basic preoperative information of patients will be collected. The vital signs, fluid treatment, and surgical anaesthesia will be recorded during the operation, while the recovery and postoperative complications will be recorded during postoperative visits. 2. The ability of sodium bicarbonate Ringer injections to reduce postoperative complications in elderly patients undergoing abdominal surgery will be observed. 3. The effects of sodium bicarbonate Ringer injection on the internal environment, such as water, electrolytes, acid-base balance, and other physiological indexes in elderly patients undergoing abdominal surgery will be observed and compared. 4. The safety and efficacy of sodium bicarbonate Ringer injection in elderly patients with abdominal diseases will be comprehensively assessed.
Keloids are the most common disfiguring skin disorder affecting colored population with a prevalence of upto 16%. Autologous adipose derived stem cells have been found to have potential therapeutic benefits however limited clinical trials have compared there role to standard therapy. This is a pilot study that is intended to evaluate the feasibility of conducting this clinical trial comparing adipose derived stromal vascular fraction to Triamcinolone in keloid treatment. The full clinical trial is already registered under the clinical trial number NCT04391621. The objective of this Pilot is to evaluate the feasibility of conducting a full study on the same topic.