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NCT ID: NCT06426563 Recruiting - Ablation Therapy Clinical Trials

MWA vs RFA for the Treatment of Moderate-sized Benign Thyroid Nodules

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

Thyroid nodule is a common condition that affects up to 60% of the population. There is an estimated 10% lifetime probability of developing a thyroid nodule. Although most thyroid nodules are benign, up to 10-15% can enlarge to cause compressive symptoms including neck pressure and discomfort, dysphagia, dyspnea, and dysphonia. The conventional treatment for these benign but problematic nodules has been thyroidectomy. Although generally a low risk operation, thyroidectomy is associated with some risk for recurrent laryngeal nerve injury, bleeding, infection, and need for thyroid hormone supplementation. Since the early 2000s, ultrasound-guided percutaneous thermal ablation has emerged as a potential alternative treatment to surgery for benign thyroid nodules. Of the myriad ablation methods, the most commonly used techniques are radiofrequency ablation (RFA) and microwave ablation (MWA). [1-3] A growing body of evidence shows that RFA is an effective treatment for benign solid thyroid nodules, toxic adenomas, and thyroid cysts resulting in overall volume reduction ranges of 40-80% at 1 year, with durable resolution of compressive and hyperthyroid symptoms. However, RFA is not without its limitations. Radiofrequency waves can be limited by the heat sink effect and tissue char leading to longer procedure times and potentially less optimal outcomes in larger, hypervascular, and/or more cystic nodules. Microwave ablation (MWA) is another ablative technique that uses electromagnetic energy waves to cause tissue hyperthermia and coagulative necrosis. It generally causes higher ablation temperatures than RFA and is less subject to the heat sink effect, and therefore can facilitate more efficient ablation procedures. Current evidence comparing RFA versus MWA for thyroid ablation was limited and was either retrospective, non-randomized [4-9], under-powered, or with an unequal baseline. The results from these studies were also conflicting, suggesting suboptimal quality of evidence and bias due to non-standardized technique of ablation across studies. To date, there is no randomized controlled trial comparing the efficacy and safety of RFA versus MWA for the treatment of benign thyroid nodules. Given the higher ablation temperatures, freedom from heat sink effect, and no influence from impedance changes during ablation, MWA may achieve different treatment efficacy.

NCT ID: NCT06422507 Recruiting - Clinical trials for Diabetic Macular Edema

A Study to Learn More About How Well 8 Milligram Aflibercept Works and How Safe it is in Chinese Participants With Diabetic Macular Edema

PHOTONiC
Start date: May 29, 2024
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat people who have diabetic macular edema. Diabetic macular edema (DME) is a diabetes-related eye disorder. In DME, the macula, which is the central part of the retina at the back of the eye, swells up resulting in vision problems. This happens due to leakage of fluid from damaged blood vessels. The study treatment, 8 milligram (mg) aflibercept is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye. A lower dose of aflibercept (2 mg) is already approved for the treatment of DME. Based on the findings of another study, the higher dose of aflibercept (8 mg) is expected to reduce the frequency of injections required for treating DME while being equally safe and working as well as the lower dose. The higher dose could make it easier to treat DME and improve quality of life for people with DME. The main purpose of this study is to learn if high-dose (8 mg) aflibercept given every 16 weeks works as well as low-dose (2 mg) aflibercept given every 8 weeks in Chinese participants. For this, the researchers will compare the change in participants' 'best corrected visual acuity' (BCVA) after 48 weeks of starting the treatment. BCVA is the clearest vision a participant can have with the help of corrective lenses, such as glasses. It will be measured by the number of letters the participant can read on an eye chart. This is known as their Early Treatment Diabetic Retinopathy Study (ETDRS) letter score. Participants will be randomly (by chance) assigned to one of two treatment groups to receive study treatment as an injection into the eye up to Week 56: - 2 mg aflibercept every 8 weeks after receiving 5 initial monthly doses - 8 mg aflibercept every 16 weeks after receiving 3 initial monthly doses Each participant will be in the study for around 63 weeks with up to 18 visits to the study site. This includes: - one visit up to 21 days before the treatment starts during which the doctors will confirm that the participant can take part in the study - 16 visits during which the treatment will be given. Most of these visits will have a gap of 4 weeks except for one visit that will happen a few days after the previous visit - one visit 4 weeks after the treatment ends During the study, the doctors and their study team will: - check the participants' vision and their overall eye health using different eye tests - check participants' health by performing tests such as blood and urine tests - ask the participants questions about the disease and study treatment and how these impact their quality of life - ask the participants what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related to the study treatment. Access to study treatment after the end of this study is not planned. Participants can switch to available approved treatments for DME.

NCT ID: NCT06418906 Recruiting - Mindfulness Clinical Trials

The Relationships Between Equanimity, Mindfulness, and Self-Compassion, and Mental Health Outcomes

Start date: May 2024
Phase:
Study type: Observational

This is an academic research study aiming to explore the relationships between equanimity, mindfulness, self-compassion, and mental health outcomes, and to examine the reliability and validity of the new measures in Hong Kong.

NCT ID: NCT06415604 Recruiting - Frailty Clinical Trials

Home-based Psychoeducation for Older Adults With Frailty: A Randomised Controlled Trial

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

This study aims to examine the effectiveness of a 12-week home-based telerehabilitation programme on improving subjective well-being among community-dwelling older people with frailty. The main question it aims to answer is - Could home-based psychoeducation significantly enhance subjective well-being in older adults with frailty in the community? Participants will receive 12 weekly online group-based sessions at their homes. The content for the experimental group and control group is different: - Intervention group: psychoeducation - Control group: physical health education Participants will receive three home visits for data collection. Some of participants in experimental group will receive interview for process evaluation.

NCT ID: NCT06409182 Recruiting - UGI Bleed Clinical Trials

A Prospective Pilot Study to Evaluate the Diagnostic Performance of a Wireless Sensor Capsule in Detection of UGIB

HemoPill
Start date: December 19, 2023
Phase: N/A
Study type: Interventional

It is a single-center, prospective study, which will be conducted in a tertiary academic hospital (Prince of Wales Hospital). All subjects will undergo a paired examination of HemoPill® acute capsule and oesophago-gastro-duodenoscopy (OGD).

NCT ID: NCT06402422 Recruiting - Healthy Clinical Trials

Vulnerability Markers for Depression

Start date: October 8, 2023
Phase:
Study type: Observational

The current study is a pilot for the GRF project entitled "Predicting illness trajectories in fully remitted major depression using concurrent TBS/fNIRS". The project aims to determine whether immediate prefrontal excitability modulated by intermittent theta-burst stimulation (iTBS) is altered in remitted major depressive disorder (rMDD) and therefore classifies as a potential trait marker to predict the incidence of recurrence. In the present cross-sectional study, we will recruit four clusters of population, including patients diagnosed with rMDD, currently depressed patients with varying numbers of episodes, healthy subjects, and never-depressed healthy subjects with elevated risk for MDD (defined as having a first-degree relative with a history of depression), to investigate the relationship between the number of prior episodes, cognitive function, and TBS-induced instantaneous brain activity change in the presumed neuropathological prefrontal cortex (PFC).

NCT ID: NCT06400862 Recruiting - Clinical trials for Traumatic Cartilage Injury

Treating Patients With Traumatic Chondral Lesions With Autologous Bone Marrow Cells Derived Engineered Tissues - Engineered Osteochondral Tissue

TCL-aMSC-eOCT
Start date: February 26, 2024
Phase: Phase 1
Study type: Interventional

The objective of the study is to establish the safety profile of the autologous engineered osteochondral tissues (eOCT) in treating traumatic chondral lesions in patients.

NCT ID: NCT06392867 Recruiting - Clinical trials for Depression, Unipolar

Intermittent Theta-burst Stimulation for Major Depression: an Intensity-response Study

Start date: January 8, 2024
Phase: N/A
Study type: Interventional

The United States Food and Drug Administration (FDA) approved intermittent theta-burst stimulation (iTBS) in 2018 as a form of repetitive transcranial magnetic stimulation (rTMS). Hospitals worldwide use it to treat major depressive disorder (MDD). It is safe, effective, even for depressed patients unable to respond to standard pharmacological treatment and is more efficient than standard rTMS. In accordance with the approved treatment protocol, patients experience considerable sensory discomfort at a stimulation intensity of 120% of their resting motor threshold (rMT). Antidepressant effects of iTBS are believed to be mediated by modulating prefrontal excitability. There is still a lack of evidence to support the choice of 120% rMT as the optimal stimulation intensity, and the presumed superiority of higher stimulation intensities over lower intensities has yet to be proven. This knowledge gap has clinical implications since more tolerated treatments may lead to greater adherence, resulting in improved outcomes. The current study proposes a randomized, triple-arm, controlled trial to compare the efficacy of iTBS at 75% (iTBS75) and 120% (iTBS120) rMT with sham iTBS (SiTBS). Based on the following considerations, SiTBS was selected to be compared with iTBS75 and iTBS120: SiTBS will reveal placebo antidepressant effects and serve as a control. iTBS75 is selected because iTBS at 80% aMT exhibits significant excitatory effects on the motor cortex and corresponds to approximately 70% rMT. There is however, a distance of about 12.7mm between the coil and the motor cortex, whereas 14.4mm separates the coil from the dorsolateral prefrontal cortex (DLPFC). Accordingly, a resting motor threshold of 70% at the motor cortex corresponds to a distance-adjusted rMT of 75% at the DLPFC. Lastly, iTBS120 is chosen as the standard stimulation intensity in current iTBS depression trials. It is our intention to investigate the potential antidepressant effects of iTBS treatment at a much lower stimulation intensity than the one currently employed by most centers in the United States and approved in these centers. Thus, our study can contribute to establishing a treatment regimen with increased adherence and lower withdrawal rates.

NCT ID: NCT06392477 Recruiting - Clinical trials for B-cell Non Hodgkin Lymphoma

A Study of DR-0201 in Subjects With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma

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

This is a multicenter, multiple expansion cohort, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-0201 in adult patients with relapsed or refractory B-cell non-Hodgkin lymphoma.

NCT ID: NCT06387706 Recruiting - Clinical trials for Chronic Pain Syndrome

The Development of a Gamified Web-based Pain Management Program (GAP) for Community-dwelling Older Adults With Chronic Pain

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

Pain Management in Older Adults: Pain significantly impacts the well-being of older adults, often leading to diminished physical abilities and a reduced quality of life. Despite this, pain management remains suboptimal, with concerns about medication side effects and a tendency to view pain as a natural aspect of aging. Consequently, many seniors are hesitant to use painkillers. As an alternative, non-pharmacological strategies such as educational programs, physical activity, massage, relaxation techniques, and music therapy are gaining traction. Innovative Non-Drug Solutions: To improve participation in non-medication pain relief methods, we suggest incorporating gaming elements into these programs (GAP). Originating in digital media in 2008, gamification has since spread across various industries. It involves adding game-like elements to activities to boost engagement, experience, and motivation. Project Goals: The aims of this initiative include creating a web-based Gamified Pain Management Program (GAP), engaging older adults with chronic pain in the development of GAP, and gathering their feedback on the program's effectiveness.