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NCT ID: NCT06429566 Active, not recruiting - Healthy Clinical Trials

Safety and Efficacy Study of GB001 Recombinant Peptide Spray in Subjects With Mild Recurrent Aphthous Ulcers

Start date: July 18, 2023
Phase: Phase 2
Study type: Interventional

This trial is conducted in China. The purpose is to evaluate the efficacy, Pharmacokinetics (PK) profile, immunogenicity and safety of GB001 recombinant peptide spray in adults with mild recurrent aphthous ulcer.

NCT ID: NCT06423261 Active, not recruiting - Healthy Clinical Trials

Safety, Tolerability, Pharmacokinetics and Immunogenicity Study of GB002 Recombinant Peptide Inhalation Solution in Healthy Subjects

Start date: August 24, 2023
Phase: Phase 1
Study type: Interventional

This trial is conducted in China. The purpose of this clinical trial is to evaluate the safety and tolerability, pharmacokinetic (PK) characteristics, and immunogenicity of single/multiple inhalation of different doses of GB002 recombinant peptide in healthy subjects.

NCT ID: NCT06422702 Active, not recruiting - Clinical trials for All Patients Are in the Initial Treatment Phase

The Effect of a Psychosomatic Symptom Intervention Program on the Primary Treatment of Differentiated Thyroid Cancer

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

Dear Sir/Madam, You are cordially invited to participate in a clinical study. Before deciding whether to participate, it is important that you understand this study. Please read the following information carefully. If you have fully understood the study, have no further questions, and decide to participate, you will need to sign an informed consent form. 1. Study Background Thyroid cancer is the most common malignant tumor of the endocrine system, with differentiated thyroid cancer (DTC) accounting for over 95% of cases. The initial treatment phase typically refers to the first year after patients undergo surgery, TSH suppression therapy, or radioactive iodine treatment. Studies have found that DTC patients may experience a variety of health-related issues during this stage. For instance, many patients not only suffer from neck discomfort and pain post-surgery but may also face risks of postoperative bleeding, nerve damage, reduced bone density, and other physical complications. They are more susceptible to anxiety, depression, sleep disturbances, and fear of recurrence. These psychological and physical symptoms can affect patients' ability to achieve target TSH levels, which is crucial for their prognosis. Therefore, this study aims to design an intervention plan for the psychosomatic symptoms of DTC patients in the initial treatment phase to improve their physiological discomfort and negative psychological experiences, enhance their self-management efficacy, and promote TSH suppression therapy compliance and overall health. 2. Study Objectives - To explore the impact of the psychosomatic symptom intervention plan on TSH levels, anxiety, depression, and self-management efficacy in patients with differentiated thyroid cancer during the initial treatment phase. - To provide a basis for improving the physical and mental health of DTC patients in the initial treatment phase. 3. Study Design and Process This study targets patients with differentiated thyroid cancer in the initial treatment phase. Participants will be divided into an intervention group and a control group using a block randomization method. The effectiveness of the plan will be tested through a 3-month intervention in a randomized controlled trial. Data collection points are baseline, at the end of the intervention, and 3 months post-intervention. The primary outcome measure is TSH levels, with secondary outcomes including anxiety, depression, and self-management efficacy. This could provide a basis for formulating scientifically sound health service policies, rational allocation and utilization of health resources, reducing the burden of medical services, and establishing a fair and efficient healthcare system. 4. Potential Benefits and Risks We will provide necessary advice for your current concerns and offer information related to differentiated thyroid cancer. Should you experience any discomfort during the study, please provide feedback to the medical staff in the research team promptly. We will dynamically assess your physiological and psychological changes and address them promptly, so there is no need for concern. 5. Handling of Harm The study involves a psychosomatic intervention lasting 12 weeks, with two sessions per week, each approximately 30 minutes. If you have any concerns during the intervention, you may contact us at any time. Our researchers, after various assessments, believe that this study will not harm your physical health. Even if you have signed this informed consent, you still retain all your legal rights. 6. Principles of Privacy and Confidentiality Your personal health information will be stored at Harbin Medical University and may be accessed by researchers, regulatory authorities, and the ethics committee. Any public reports on the results of this study will not disclose your personal identity. We will make every effort to protect your personal privacy within the legally permitted scope. By signing this informed consent, you agree to the use of your personal and health information as described above. 7. Voluntary Principle Participation in this study is entirely voluntary. You may refuse to participate or opt out of the study at any time without any reason. This decision will not affect your future daily life. However, it is hoped that you will complete this study unless there are special reasons. If you decide to withdraw under any circumstances, please inform the researchers. 8. Participant's Responsibilities Once you agree to participate in this study, you should cooperate with the researchers to complete the intervention study and promptly feedback your health recovery status to the researchers during the intervention. 9. Consultation about the Study If you have any questions related to this study, please contact the project leader: Shuhua Luo, at 17382839336.

NCT ID: NCT06422130 Active, not recruiting - Children Clinical Trials

Ningbo Maternity-Child Linked Database Study

MATCHLESS
Start date: October 1, 2016
Phase:
Study type: Observational [Patient Registry]

With the implementation of China's two-child policy and a marked increase in adverse pregnancy outcomes, leveraging electronic health records (EHR) to enhance maternal and child healthcare and outcomes in China has emerged as a novel strategy to tackle this pivotal demographic and health challenge. Given the mature construction of the information platform and the well-established maternal and child health service system in Ningbo, this study utilized the Ningbo Maternal and Child Health Electronic Monitoring Information Management System and the Ningbo Regional Health Information Platform to conduct the Ningbo maternity-child linked database study (MATCHLESS), which involved over 300,000 mother-child pairs in China. MATCHLESS not only allows for longitudinal follow-up of pregnant women and their offspring but also expands its scope from prenatal exposure to long-term outcomes through data linkage. The longitudinal scope of MATCHLESS facilitates the elucidation of the relationship and etiological significance of early-life exposures and adverse pregnancy outcomes. It also permits the exploration of the health trajectory of women and children over their life-course. During the past 5 years (October 2016 to December 2021), a substantial amount of maternal and child health data has been recorded in MATCHLESS, including socio-demographics, health care services and medications, as well as clinical outcome events. Additionally, it contains longitudinal measurements on risk factors for adverse pregnancy outcomes, which provides a robust foundation for future real-world studies of dynamic predictive models. This study was approved by the Ethics Review Committee of the Ningbo University Health Science Center. Considering the safety, privacy, and confidentiality concerns surrounding the storage and processing of personal EHR data, the responsibility for data storage and management is undertaken by the Health Commission of Ningbo. Researchers are required to submit applications to the local health department, and all studies undergo ethical review and research registration procedures to access EHR data for health research purposes.

NCT ID: NCT06419673 Active, not recruiting - Cervical Cancer Clinical Trials

Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer

Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

This study is a prospective, multicenter, randomized, open controlled clinical trial aimed at evaluating the effectiveness and safety of serplulimab plus chemoradiotherapy in FIGO 2018 stage III or IVA cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma patients who have not received prior treatment.

NCT ID: NCT06410677 Active, not recruiting - Clinical trials for Esophageal Squamous Cell Carcinoma

Changhai Multimodal Esophageal Cancer Cohort

CMECC
Start date: June 13, 2018
Phase:
Study type: Observational

The burden of esophageal squamous cell carcinoma (ESCC) in China is substantial, with 85% of the cancers being in the progressive stage. The treatment for advanced ESCC are extremely limited, and immunotherapy, represented by PD-1 inhibitors, has demonstrated a promising application potential. However, the effectiveness of PD-1 inhibitors varies significantly among patients with different types of ESCC, and currently, there is no effective method to predict the response to PD-1 inhibitors. In this study, investigators aim to construct a multimodal deep learning-based model to predict the level of immune infiltration and the efficacy of immunotherapy for ESCC, integrating both pathological image features and clinical information of patients with ESCC, thereby enhancing the level of individualized and precise treatment for ESCC.

NCT ID: NCT06410040 Active, not recruiting - Brain Metastases Clinical Trials

A Retrospective Study of the Efficacy and Safety of Lolatinib in ALK+ NSCLC Patients With Brain or Meningeal Metastasis

Start date: August 20, 2023
Phase:
Study type: Observational

This study was a retrospective observational study. The study included patients with non-small cell lung cancer with ALK-fusion brain metastases or meningeal metastases who received first-line and late-line treatment with the third-generation ALK TKI lorlatinib between June 2022 and June 2023. Data were collected from the electronic medical records database and hospital information system of many hospitals in Sichuan Province. Clinical pathology features including gender, age, ALK mutation status at diagnosis, and clinical stage at diagnosis were collected from the medical records. The physical condition assessed by ECOG-PS before the administration of lorlatinib was recorded. Information on anti-tumor therapy was obtained from the records, including dose and time of ALK-TKI therapy and tumor response, number of prior systemic therapy lines, drug regimen, efficacy, and whether local therapy such as radiotherapy and surgery had been received. In this study, the sample size is not limited, and information is collected according to the maximum number of patients. The study period was from 01 July 2023 to 30 June 2024.

NCT ID: NCT06405737 Active, not recruiting - Healthy Clinical Trials

Oxytocin's Effect on the Advantageous- and Disadvantageous-inequity

Start date: January 7, 2024
Phase: N/A
Study type: Interventional

The main aim of the study is to investigate whether intranasal oxytocin modulates advantageous- and disadvantageous-inequity and whether oxytocin has similar effects on them or not.

NCT ID: NCT06403709 Active, not recruiting - Clinical trials for Metastatic Colorectal Cancer

Irinotecan, TAS-102 Plus Bevacizumab as a Third-Line or Beyond Therapy in mCRC Patients

Start date: August 1, 2022
Phase: Phase 2
Study type: Interventional

Currently, the approved third-line treatments for metastatic colorectal cancer (mCRC) include regorafenib, fruquintinib, and trifluridine/tipiracil(TAS-102). In recent years, several phase I/II studies evaluated the combination of TAS-102 and bevacizumab in mCRC patients who were refractory to standard therapies and showed promising antitumor efficacy and manageable toxicity. In this single-center phase II study, the investigators explored the efficacy and safety of irinotecan, TAS-102, plus bevacizumab in a third-line or beyond therapy for patients with mCRC.

NCT ID: NCT06396780 Active, not recruiting - Clinical trials for Helicobacter Pylori Infection

Treatment Adherence And Influencing Factors in Children With Helicobacter Pylori Infection During Eradication Therapy

Start date: March 30, 2024
Phase:
Study type: Observational

The aim of this study is to describe the current status of treatment adherence in children with Helicobacter pylori infection, understand the medication literacy, medication beliefs of the children, knowledge of H. pylori among caregivers, medication beliefs, medication support, and explore the influencing factors of medication adherence.