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NCT ID: NCT05517148 Completed - Stress Clinical Trials

Effects of an Immersive Virtual Reality Intervention Combined With Mindfulness-based Stress Reduction

Start date: September 25, 2022
Phase: N/A
Study type: Interventional

Mindfulness-based stress reduction (MBSR), a widely used method to improve mental state and sleep quality, was developed by Kabat-Zinn in 1970. The meditation of MBSR is effective in regulating patients' emotions, leading to reduced stress, pain, and psychological symptoms. Studies have demonstrated that MBSR has a positive impact on multiple psychological and physical symptoms in a variety of cancers. On this basis, investigators found that VR treatment can also help patients relax, and it has been widely used in cancer symptom relief in recent years. VR treatment involves using headset devices that fully restrict the vision field to content displayed inside the headset screen; As a treatment modality, VR provides a unique environment comprising 3D visually immersive experiences that are enriched with stereo sounds and elements such as rich colors and scenic environments that enhance elicitation of desired states of arousal and affect. Within the therapeutic context, VR may be flexibly designed and tailored to address the needs of specific conditions (eg, anxiety, depression, pain) auditory perception is not fully restricted, though the corresponding device-delivered auditory content commands attention.

NCT ID: NCT05516966 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus

Start date: October 12, 2022
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to assess the safety and tolerability of multiple subcutaneous injections of HRS9531 in patients with type 2 diabetes mellitus who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.

NCT ID: NCT05516940 Active, not recruiting - Healthy Clinical Trials

A Study of the Impact of Different Delivery Modes on Specific Macronutrient Components in Human Milk

ZoomMING
Start date: May 6, 2022
Phase:
Study type: Observational

The aim of the study is to evaluate the impact of different delivery modes on specific macronutrient components in human milk.

NCT ID: NCT05516914 Recruiting - Malignant Tumors Clinical Trials

A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors

Start date: September 1, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This trial is an open and multicenter phase Ib/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.

NCT ID: NCT05516758 Active, not recruiting - Clinical trials for Rheumatoid Arthritis

A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis

RESOLUTION-1
Start date: August 31, 2022
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis.

NCT ID: NCT05516680 Recruiting - Healthy Clinical Trials

Effects and Central Mechanism of Electroacupuncture and MRI-navigated rTMS for PSD

Start date: October 22, 2022
Phase: N/A
Study type: Interventional

Introduction: Post-stroke depression (PSD) is the most common mental complication after stroke and has a serious impact on functional outcomes and quality of life. Antidepressants are the first-line treatment for PSD, but many reported side effects remain. Clinical research and practice guidelines have shown that electro-acupuncture and rTMS have a positive effect on PSD. This trial aims to study the efficacy and safety of electro-acupuncture and a modern MRI-navigated rTMS for PSD and to explore its fMRI-based central mechanism on depression. It is hypothesized that electro-acupuncture and MRI-navigated rTMS treatment improves depressive symptoms, neuro-patho-physiological behaviors, quality of life and central response in PSD. Methods: In this randomized, controlled, assessors-blinded trial, sixty-four patients with PSD will be randomly allocated into the experiment group (n=32) or control group(n=32) . The experiment group will receive electro-acupuncture and MRI-navigated rTMS, and the control group will receive MRI-navigated rTMS treatment, in 12-20 sessions over 4 weeks. In addition, ten healthy people for fMRI scanning will be recruited as a healthy control group without any intervention. The primary outcome is the change from baseline in the Hamilton Depression Scale-24 items (HAMD-24) scores at week 4. The primary analysis of central mechanism mainly involves cortical morphology, local spontaneous brain activity, and default mode network (DMN) functional connectivity based on fMRI at 0-wk and 4-wk. Secondary outcomes include the neuro-patho-physiological and quality of life changes in cortical excitability with motor evoked potential test(MEP), National Institutes of Health Stroke Scale(NIHSS), EuroQol Five Dimensions Questionnaire(EQ-5D) Scale, Modified Barthel Index(MBI) Scale and Short Form-Health Scale of Traditional Chinese Medicine(SF-HSTCM). Additional indicators include the Acceptability Questionnaire and Health Economics Evaluation (cost-effectiveness analysis) to assess acceptability and economic practicality of the treatment in study. Outcomes are assessed at baseline and post intervention. Discussion: Electro-acupuncture and MRI-navigated rTMS therapy could become an alternative treatment for PSD, and it is expected that this trial will provide reliable clinical evidence and potential effect mechanism for the future use of electro-acupuncture and MRI-navigated rTMS for PSD.

NCT ID: NCT05516589 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Neoadjuvant Chemotherapy, Tislelizumab With Afatinib for HNSCC

neoCHANCE-2
Start date: August 20, 2022
Phase: Phase 2
Study type: Interventional

To explore the efficiency and safety of TP chemotherapy, tislelizumab, combined with afatinib as a new neoadjuvant treatment regimen for patients with resectable HNSCC.

NCT ID: NCT05516498 Recruiting - Liver Cirrhosis Clinical Trials

Zibotentan and Dapagliflozin Combination, EvAluated in Liver Cirrhosis (ZEAL Study)

ZEAL
Start date: October 31, 2022
Phase: Phase 2
Study type: Interventional

This is a two part Phase IIa/b multicentre, randomised, double-blind, placebo-controlled, parallel group dose-ranging study to assess the efficacy, safety, and tolerability of the combination of zibotentan and dapagliflozin, and dapagliflozin monotherapy versus placebo in participants with cirrhosis with features of portal hypertension.

NCT ID: NCT05516329 Completed - Prostate Cancer Clinical Trials

Study of 18F-Thretide PET/CT in Patients With Prostate Cancer

Start date: August 20, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates the diagnostic performance and safety of 18F-Thretide PET/CT in patients with biopsy proven prostate cancer who has no any form of therapy against prostate caner or suspected recurrence of prostate cancer who have negative or equivocal findings on conventional imaging.

NCT ID: NCT05516251 Recruiting - Migraine, Classic Clinical Trials

Transcutaneous Supraorbital Nerve Stimulator Versus Topiramate in Prevention of Recurrent Migraine

Start date: October 1, 2021
Phase: N/A
Study type: Interventional

Migraine has been ranked as the second most disabling neurological disorder in the worldwide. Medication or nonpharmacological treatments are all reasonable options for the prevention. Oral topiramate treatment is a typical effective method, while transcutaneous supraorbital nerve stimulation (SNS) was reported to be valuable for migraine acute treatment and even the prevention. As a new nonpharmacological therapeutic method, whether SNS is equivalent to topiramate is still unknown. The aim of the present study was to compare their effects in a cohort of migraine patients. After diagnosed with recurrent or chronic migraine and consented to this research, patients received randomly treatments by either SNS or topiramate, and were followed up prospectively. After a 1-month period of baseline observation, patients were followed by a 1-month treatment, and next 2-month period of followup. At least the following assessments will be performed: (1) Change from baseline in the number of migraine days during the 3 observing months; (2) Change from baseline in the number of moderate/ severe headache days over the 3 observing months; (3) 50% responder rate for the reduction of migraine days (percentage of patients having at least 50% reduction of migraine days) during the first treating month. Comparison of outcome measures between the 2 treatment groups will be performed to show the equivalence of SNS versus topiramate.