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NCT ID: NCT06433791 Not yet recruiting - Safety Clinical Trials

Evaluation of Ascorbate-Meglumine Therapeutic for SRS

Start date: June 17, 2024
Phase: Phase 1
Study type: Interventional

Phase 1, Single-Center, Dose-Escalating, Open-Label, Safety Clinical Trial of Parenteral Ascorbate-Meglumine as a Novel Magnetic Resonance Imaging (MRI)-guided Adjunctive Therapeutic for Stereotactic Radiosurgery (SRS)

NCT ID: NCT06429033 Not yet recruiting - Safety Clinical Trials

Purified Exosome Product (PEP) Injected Into the Hypodermis

PEP
Start date: July 1, 2024
Phase: Phase 1
Study type: Interventional

This clinical trial aims to learn if Purified Exosome Product (PEP) is safe and tolerable when injected into the hypodermis of healthy adults. The main questions this study aims to answer are: Is PEP safe and tolerable when injected into the hypodermis of healthy adults? Are there signals of Collagen I/II and Elastin biostimulation? Subjects will serve as their own control and researchers will compare PEP to Control to see if PEP is safe.

NCT ID: NCT05915481 Not yet recruiting - Clinical trials for Advanced Solid Tumor

Stereotactic Body Radiotherapy Combined With Cadonilimab for Advanced Refractory Malignant Solid Tumors

SCARCE
Start date: June 21, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this multicenter prospective single-arm phase I/II study is to study the safety and efficacy stereotactic body radiotherapy (SBRT) combined with Cadonilimab for advanced refractory malignant solid tumors. The main questions it aims to answer are: - How safe is this regimen of SBRT combined with Cadonilimab for advanced refractory malignant solid tumors? - How effective is this regimen of SBRT combined with Cadonilimab for advanced refractory malignant solid tumors? Participants will receive SBRT combined with Cadonilimab until disease progression or intolerable toxicities or death.

NCT ID: NCT05911087 Not yet recruiting - Safety Clinical Trials

A Phase II/III Study to Evaluate the Immunogenicity and Safety and Efficacy of SWIM816 Vaccines for SARS-CoV-2

Start date: June 20, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Primary Immunogenicity Objective:Cohort 1: GMTs of SARS-CoV-2 Omicron and related strain neutralizing antibody levels for SWIM816.Cohort 2: To demonstrate the non- inferiority of neutralizing antibody response in terms of geometric mean titers (GMT) of COVID-19 mRNA vaccine(SWIM816) compare with mRNA COVID-19 vaccine(Pfizer Bivalent vaccine) 14 days post dose. Primary Safety Objective:To assess the reactogenicity and safety of a booster dose in a heterologous vaccination regimen in subjects previously immunized with 2/3 doses of COVID-19 vaccine with or without previously diagnosed with COVID-19. Secondary Immunogenicity Objectives:To describe the neutralizing antibody response at D29, D91 and D181.To describe binding antibody profile at D01, D15, D29, D91 and D181 of each study group. Secondary Safety Objective:To assess the reactogenicity and safety of third or fourth booster dose in a heterologous vaccination regimen in subjects previously immunized with 2/3 COVID-19 vaccine doses. Exploratory Objective:1.Documented confirmed SARS-CoV-2 symptomatic infection;2.Todemonstrate the cellular immune response profile at study group (30 subjects per each group for cellular immune testing).

NCT ID: NCT05620199 Not yet recruiting - Surgery Clinical Trials

Upfront Resection of Locally Advanced NSCLC Followed by Chemoradiotherapy

UPLAN-I
Start date: April 1, 2023
Phase: N/A
Study type: Interventional

For patients with irresectable locally advanced non-small cell lung cancer (NSCLC) (e.g. multilevel or bulky N2 disease or presence of N3 lymph node metastases), current guidelines recommend treatment with chemoradiotherapy (CRT) followed by immune checkpoint inhibition (ICI, durvalumab). Chances of sterilization of a large (e.g. clinically staged T3 or T4 tumor) tumor volume by CRT alone are relatively small and these tumors are associated with a high local recurrence rate. Moreover, necrosis and cavitation of these tumors puts these patients at risk of fatal bleeding and might cause infectious complications, which lead to subsequent impaired quality of life (QoL) and to interruption of, or the need for postponing, (systemic) treatment. Upfront resection of the tumor in the lung, followed by postoperative CRT in patients who have a (potentially) resectable tumor could be a strategy to prevent complications of CRT in large volume and/or cavitating tumors with extensive mediastinal disease.

NCT ID: NCT05430867 Not yet recruiting - Alzheimer Disease Clinical Trials

Efficacy and Safety of Memantine and Sodium Oligomannate in Patients With Moderate to Severe Alzheimer's Disease

Start date: July 1, 2022
Phase: Phase 4
Study type: Interventional

Alzheimer's disease (AD) is the main cause of dementia. At present, AD is incurable. Memantine is recommended for the treatment of moderate and severe AD patients. Sodium oligomannate (GV-971) is a marine-derived oligosaccharide. It is proposed that it can reconstitute the gut microbiota, and inhibit neuroinflammation in the brain as observed in animal models. It reduces Aβ deposition in the brain of Aβ-transgenic mice. The reduction in both Aβ deposition and neuroinflammation may synergistically contribute to the improvement of cognitive impairment and delay the progress of the disease. China Food and Drug Administration(CFDA)approved it for the treatment of mild to moderate AD in 2019. Due to the different mechanism of memantine and GV-971, theoretically, they may synergistically improve cognitive function and delay disease progression. However, there is a lack of data on their effectiveness and safety. Therefore, the purpose of this study is to compare the efficacy and safety of memantine and GV-971 monotherapy and combination therapy in patients with moderate to severe AD, which is of great significance for guiding the treatment of moderate and severe AD.

NCT ID: NCT05406102 Not yet recruiting - Safety Clinical Trials

Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal Endoscopy

Start date: July 10, 2022
Phase: Phase 4
Study type: Interventional

Gastroenteroscopy diagnosis and treatment drugs need to meet the needs of quick onset, quick recovery and less anesthesia complications. Remimazolam is an anesthetic sedative independently developed by China. It is a new short-acting GABA(A) receptor agonist. Remimazolam has the advantages of rapid onset, rapid recovery, antagonist, controllable degree of cardiovascular and respiratory depression, low incidence of hypotension and respiratory depression. However, elderly patients as important and special patients, there are still a lack of relevant studies and reports. In order to verify the safety and effectiveness of remimazolam in the gastroenteroscopy treatment of elderly patients, it can reduce the incidence of intraoperative hypotension or respiratory depression rate, improve the quality of recovery of elderly patients.

NCT ID: NCT05381870 Not yet recruiting - Pharmacokinetics Clinical Trials

Bioequivalence Study of Ezetimibe Tablets Under Fasting Conditions in Healthy Subjects

Start date: May 26, 2022
Phase: Phase 1
Study type: Interventional

The fasting bioequivalence test adopts the experimental design of single center, single oral administration, random, open, two sequence, two cycle crossover and self-control.

NCT ID: NCT05325684 Not yet recruiting - Safety Clinical Trials

PD-L1 Inhibitor Rechallenge After PD-1 Immunotherapy for Patients With Solid Tumor Beyond Lung Cancer

Start date: April 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Anti-PD-L1 immune checkpoint inhibitor, is approved for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy, or as first-line treatment of patients with ES-SCLC in combination with etoposide and either carboplatin or cisplatin in China. The clinical data regarding the PD-L1 inhibitor in other solid tumors are limited.Investigators would observe and analyze the effectiveness and safety of PD-L1 inhibitor for patients with advanced - solid tumors beyond lung cancer after muti-line therapy to explore the synergistic effect of PD-L1 inhibitor rechallenge after PD-1immunotherapy.

NCT ID: NCT05177666 Not yet recruiting - Safety Clinical Trials

a Prospective Registration Study for Patients With Advanced Refractory Solid Tumors

Start date: December 30, 2021
Phase:
Study type: Observational

This is a prospective registration study for patients with advanced refractory solid tumors. Patients who meet the eligibility criteria will be included to participate in the study, and baseline information to be collected after signed informed consent. Patients will choose for themselves whether to carry out targeted therapy or other appropriate treatment methods. And we plan to follow up for at least 12 months or until disease progression or death.