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NCT ID: NCT05858164 Recruiting - Clinical trials for Non-small Cell Lung Cancer

A First-in-human Study to Learn How Safe the Study Treatment BAY2862789 is, to Find the Best Dose, How it Affects the Body, What Maximum Amount Can be Given, How it Moves Into, Through and Out of the Body, and How it Acts on Different Tumors in Participants With Advanced Solid Tumors

Start date: August 7, 2023
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat people who have advanced solid tumors including a specific kind of lung cancer (non-small cell lung cancer, NSCLC). Advanced solid tumors are types of cancer that have spread to nearby tissue, lymph nodes, and/or to distant parts of the body and that are unlikely to be cured or controlled with currently available treatments. BAY2862789 works by blocking an enzyme in T-cells, thereby activating them. T-cells are a type of immune cell that are known to have an anti-cancer effect. The main purpose of this first-in-human study is to learn: - how safe different doses of BAY2862789 are, - the degree to which medical problems caused by BAY2862789 can be tolerated (also called tolerability), - what maximum amount (dose) can be given, and - how BAY2862789 moves into, through and out of the body. To answer this, the researchers will look at: - the number and severity of medical problems participants have after taking BAY2862789 for each dose level. These medical problems are also referred to as adverse events. An adverse event is considered "serious" when it leads to death, puts the participants' lives at risk, requires hospitalization, causes disability, causes a baby being born with medical problems or is otherwise medically important. - the (average) total level of BAY2862789 in the blood (also called AUC) after intake of single and multiple doses. - the (average) highest level of BAY2862789 in the blood (also called Cmax) after intake of single and multiple doses. Doctors and their team keep track of all medical problems that participants have during the study, even if they do not think the medical problem might be related to the study treatment. In addition, the researchers want to know if and how the participants' tumors change after taking BAY2862789. The study will have two parts. The first part, called dose escalation, is done to find the most appropriate dose that can be given in the second part of the study. For this, each participant will receive one of the increasing doses of BAY2862789. All participants in the second part of the study, called dose expansion, will receive the most appropriate dose identified from the first part of the study, as tablet by mouth. Participants in both parts of the study, will take the study treatment until their tumor gets worse (also known as 'disease progression'), until they have medical problems, until they leave the study, or until the study is terminated. Each participant will be in the study for several months, including a test (screening) phase of up to 28 days, few months of treatment depending on the participant's benefit, and a follow up phase after the end of treatment. The following approximate numbers of visits to the study site are planned: two during the screening phase, six in the first treatment month, one to three per month in the following periods. During the study, the study team will: - take blood and urine samples - do physical examinations - check vital signs such as blood pressure, heart rate, body temperature - examine heart health using ECG (electrocardiogram) - check cancer status using CT (computed tomography) or MRI (magnetic resonance imaging) and, if needed, bone scans - take tumor samples (if required) - pregnancy test The treatment period ends with a visit no later than 7 days after the last BAY2862789 dose. The study doctors and their team will check the participants' health and any changes in cancer about 30 and 90 days after the last dose and every 12 weeks thereafter. This follow-up period ends if the cancer worsens, if a new anti-cancer treatment is started, or until the participant leaves the study. In addition, the study doctors and their team will contact the participant every 12 weeks to learn about the participant's survival. This ends no later than 12 months after the last participant started treatment or by the end of the study, whichever comes first. If the study participant benefits from treatment, continuation of treatment with BAY2862789 beyond the duration of this study might be possible.

NCT ID: NCT05858060 Recruiting - Clinical trials for Subarachnoid Hemorrhage, Traumatic

Osmotic Therapy for Patients With Severe Subarachnoid Hemorrhage

OSMO-SAH
Start date: July 10, 2023
Phase:
Study type: Observational

The goal of this prospective multi-center observational study is to learn about the osmotic therapy in severe subarachnoid hemorrhage (SAH). The main question[s] it aims to answer are: • whether the two osmotic therapy, 20% mannitol and 10% hypertonic saline(HTS), under the same osmotic equivalent, has similar influence on the outcome of SAH patients? Participants will be given proper treatment according to local expert consensus, including the choice of osmotic medicine. Investigators just record and analyse the data, compare mannitol group and HTS group to see if the outcome of latter is not worse than the former.

NCT ID: NCT05858047 Completed - Effects, Drug Side Clinical Trials

An Investigational Study to Evaluate Experimental Medication SYHX1901 Tablets With Moderate to Severe Plaque Psoriasis

Start date: April 11, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of different doses of SYHX1901 tablets in the treatment of moderate to severe plaque psoriasis in order to select doses for further clinical trials.

NCT ID: NCT05857982 Recruiting - Clinical trials for Relapsed/Refractory Multiple Myeloma

Mitoxantrone Hydrochloride Liposome Injection in the Treatment of Relapsed/Refractory Multiple Myeloma

Start date: May 20, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

A prospective, open-label, single-arm clinical study of mitoxantrone hydrochloride liposome injection combined with daratumumab and dexamethasone in the treatment of relapsed/refractory multiple myeloma

NCT ID: NCT05857917 Recruiting - Clinical trials for Renal Function Disorder

Virtual Reality for for Pain and Anxiety Distraction Strategy on Peritoneal Catheter Insertion

Start date: April 17, 2023
Phase: N/A
Study type: Interventional

This clinical trial aims to investigate the effect of VR application on reducing preoperative anxiety and the intraoperative and postoperative pain of patients who undergo peritoneal dialysis catheter insertion. The main questions it aims to answer are: 1) Whether preoperative VR application can reduce preoperative anxiety in patients undergoing peritoneal dialysis catheter insertion; 2) Whether intraoperative VR application can reduce intraoperative and postoperative pain in patients undergoing peritoneal dialysis catheter insertion; 3) Whether VR application can improve patients satisfaction of the operation. Participants will be randomly assigned to the VR group and control group, and participants in the VR group will be introduced to VR use and watch a VR video about the operating room environment 1 day before the surgery. During the procedure, participants in the VR group will watch a soothing video through the VR device. In contrast, participants in the control group will receive the usual preoperative and surgical procedures. Preoperative anxiety, intraoperative and postoperative pain, and patient satisfaction will be compared between the two arms.

NCT ID: NCT05857904 Not yet recruiting - Clinical trials for Coronary Artery Disease

Clinical Outcomes of CT-FFR Versus QFR-guided Strategy for Decision-Making in Patients With Stable Chest Pain

CONFIDENT
Start date: May 2023
Phase: N/A
Study type: Interventional

This study is a multicenter, prospective, blinded (blinding of clinical evaluators), randomized controlled, event-driven non-inferiority clinical trial. Eligible subjects who meet the inclusion criteria will be registered in the central randomization system and randomized in a 1:1 ratio to either the experimental group (CT-FFR guided group) or the control group (QFR guided group).

NCT ID: NCT05857891 Recruiting - Clinical trials for Acute Respiratory Distress Syndrome

The Effect of Erythropoietin on Alveolar Fluid Clearance in Patients With Acute Respiratory Distress Syndrome

Start date: May 20, 2023
Phase: N/A
Study type: Interventional

Acute respiratory distress syndrome (ARDS) is a common acute and critical disease in clinic. The clinical mortality is as high as 30%-40%. At present, there is no specific treatment. Erythropoietin (EPO), also known as erythrocyte- stimulating factor, erythropoietin, has a certain amount in normal human body, mainly synthesized by liver in infants and kidneys in adults, which can stimulate erythropoiesis. In recent years, more and more studies have shown that high-dose exogenous EPO administration has benefit effects on multi-organ protection. Therefore, we designed this prospective, double-blind, placebo-controlled trial for defecting EPO on the alveolar fluid clearance of ARDS. The study mainly answers the following questions: Does human erythropoietin accelerate the resolution of alveolar edema in ARDS? Is there any effect on hospital survival? The study will draw conclusions by comparing the control group with the experimental group.

NCT ID: NCT05857800 Recruiting - Lung Cancer Clinical Trials

Exploring the Neo-Adjuvant Therapy Effects on Lung Cancer Through Monitoring and Assessment of Tumor Environment

NAT-LungMate
Start date: May 25, 2023
Phase:
Study type: Observational [Patient Registry]

This translational study aims to investigate how neoadjuvant therapy affects lung cancer patients by monitoring dynamic changes in the tumor environment. The study focuses on patients with histologically confirmed lung cancer, including non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), who are eligible for neoadjuvant therapy in the LungMate clinical trial series. By analyzing intra-tumour genetic and functional heterogeneity following neoadjuvant therapy through multi-omic analysis (including genomics, transcriptomics, metabolomics and proteomics), this study could potentially identify new biomarkers or therapeutic targets that could improve lung cancer patient outcomes.

NCT ID: NCT05857449 Completed - Healthy Clinical Trials

An Exploratory Study of LPM3480392 at Different Infusion Rates in Chinese Healthy Subjects

Start date: November 8, 2021
Phase: Phase 1
Study type: Interventional

This study evaluated the safety, tolerability and PK/PD characteristics of LPM3480392 injection by intravenous infusion at different rates in healthy subjects.The experiment was divided into Part A and Part B. Part A is a open label ,three cycle , fixed sequence dosing study .Twelve healthy male subjects were planned to be enrolled, and the same dose (X1mg)of LPM3480392 injection was intravenously injected at different infusion times in different drug administration cycles. Part B is an open label ,two cycle , fixed sequence dosing study .Ten healthy male subjects (subjects not enrolled in Part A) were given LPM3480392 injection in 2 minutes , each subject was given X2mg at the first cycle and X3mg at the second cycle .

NCT ID: NCT05857410 Completed - Spine Surgery Clinical Trials

Scheme of Limb Warming Blanket Combined With Dexmedetomidine

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Objective: To observe the clinical effect of lower limb warming blanket combined with dexmedetomidine (DEX) in preventing postoperative delirium (POD) and chills in elderly patients undergoing spinal surgery. Methods: A total of 160 elderly patients undergoing posterior spinal surgery under general anesthesia were selected and divided into control group (group N), heating group (group T), DEX group (group D) and heating combined with DEX group (group TD) according to the random number table method, 40 cases in each group. T group and TD group routine insulation and lower limb heating blanket. DEX was injected in group D and group TD. The dosage of anesthetics, the changes of body temperature and heart rate at different time points during operation, and the occurrence of postoperative chills and POD were compared among the groups.