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NCT ID: NCT05371080 Active, not recruiting - Herpes Zoster Clinical Trials

A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults

Start date: August 10, 2022
Phase: Phase 3
Study type: Interventional

The purpose of the current ZOSTER-101 long-term follow-up (LTFU) study of ZOSTER-049 (NCT02723773) study, an extension of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies, is to assess the long-term vaccine efficacy (VE) against Herpes Zoster (HZ) (approximately 11-15 years post primary vaccination in ZOSTER-006/022 studies), persistence of immunogenicity and safety of GSK's Herpes Zoster subunit (HZ/su) vaccine in older adults. The persistence of immunogenicity and safety of 1 or 2 additional doses (0, 2-month schedule) of HZ/su vaccine administered to a small group of participants in ZOSTER-049 study (approximately 5 years after the initial vaccination in ZOSTER-006/022 studies) will also be assessed.

NCT ID: NCT05338970 Active, not recruiting - Clinical trials for Nonsquamous Non-small Cell Lung Cancer

HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

Start date: July 8, 2022
Phase: Phase 3
Study type: Interventional

Disease progression is typical for patients with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Standard platinum-based chemotherapy offers limited efficacy and an unfavorable safety profile.There is an urgent need for more effective and tolerable therapies for patients with EGFRm NSCLC who have exhausted available targeted therapies. Clinical evidence suggest that patritumab deruxtecan constitutes a promising investigational therapy for patients with EGFRm NSCLC.

NCT ID: NCT05330429 Active, not recruiting - Clinical trials for Metastatic Colorectal Cancer

Study of Magrolimab Given Together With FOLFIRI/BEV in Patients With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)

ELEVATE CRC
Start date: July 8, 2022
Phase: Phase 2
Study type: Interventional

The goals of this clinical study are to learn more about the safety, tolerability and effectiveness of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC). The primary objectives of this study are: (safety run-in cohort) to evaluate safety and tolerability, and the recommended Phase 2 dose (RP2D) and (randomized cohort) to evaluate the efficacy of magrolimab in combination with bevacizumab and 5-fluorouracil, irinotecan, and leucovorin (FOLFIRI) in previously treated participants with advanced inoperable metastatic colorectal cancer (mCRC).

NCT ID: NCT05308758 Active, not recruiting - Clinical trials for Adhd Deficits in Attention Motor Control and Perception

Effect of Game-based HIIT Program on the Executive Function of Children With ADHD

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

Background: Attention-deficit/hyperactivity disorder (ADHD) is a common developmental disorder in childhood, with a 5%-6% worldwide prevalence. Children with ADHD often demonstrate impaired executive function, which is closely related to the development of the commonly observed behavioral problems such as inattention, impaired inhibition, and hyperactivity. The purpose of this study is to examine whether a game-based high-intensity interval training (HIIT) program can improve the executive function of children with ADHD, compared with a traditional structured aerobic exercise program and a non-treatment control group. Methods/design: A total of 42 children with ADHD will be recruited to participate in this three-arm school-based randomized controlled trial. An 8-week specially designed game-based HIIT (GameHIIT) program and a traditional game-based structured aerobic exercise (GameSAE) program will be delivered to those children randomly assigned to these two intervention groups, while the children in the control group will maintain their regular physical activity over the same period. A number of outcome measures including executive function, cerebral hemodynamic response, physical activity, physical fitness, and enjoyment and adherence to the intervention will be assessed for both groups at baseline (T0), immediately after the intervention period (T1), and after the follow-up period (T2). Discussion: HIIT has recently emerged as a feasible and efficacious strategy for increasing physical health outcomes and cognitive function, including executive function, in healthy young people. However, research has yet to investigate whether the executive function of children with ADHD can be effectively enhanced through HIIT. If, as hypothesized, GameHIIT program improves outcomes for children with ADHD, the present research will inform the development of targeted exercise programs that can be more broadly used with this particular population. Keywords: Special education need, Physical activity, fNIRS,

NCT ID: NCT05304988 Active, not recruiting - Cancer Clinical Trials

Development and Validation of the EFT for Adolescents With Cancer

Start date: September 7, 2020
Phase:
Study type: Observational

There is increasing evidence of interventions shown to be effective to promote physical activity in adolescents with cancer. Nevertheless, adolescents with cancer become physically inactive after the end of the interventions. These interventions emphasized heavily on interventionists' role to assess adolescents' physical fitness and prescribe exercises. After the intervention, the adolescents were unable to follow the previous exercise prescriptions due to their changing medical conditions. To promote physical activity sustainably, it is vital to develop a patient-based assessment tool to allow adolescents with cancer to self-assess their own appropriate levels of physical activity that they could perform. However, a review of literature indicates a lack of such a tool.

NCT ID: NCT05288686 Active, not recruiting - Breast Cancer Clinical Trials

Use of Superparamagnetic Iron Oxide (SPIO) in Sentinel Lymph Node Detection for Breast Cancer

Start date: July 24, 2018
Phase: N/A
Study type: Interventional

Sentinel lymph node biopsy is mandatory during breast cancer operation for disease staging and treatment. The localization of sentinel lymph node is by the injection of radioisotope and blue dye, which is the gold standard. However the use of radioisotope and blue dye are associated with specific drawbacks. Superparamagnetic iron oxide is a magnetic tracer which is FDA-approved for sentinel lymph node localization. The hypothesis of this study is superparamagnetic iron oxide can replace the conventional dual mapping of radioisotope and blue dye in the detection of sentinel lymph nodes for early breast cancers.

NCT ID: NCT05278299 Active, not recruiting - POAG Clinical Trials

Asia Glaucoma Registry

Start date: October 1, 2021
Phase:
Study type: Observational

Glaucoma remains a leading cause for irreversible visual impairment and blindness worldwide and it disproportionately affects people residing in Asia, there is a need to ensure optimal management of the disease in patients with glaucoma. The ability to estimate the rates of structural and functional loss in patients with glaucoma will enable clinicians to identify those with rapidly deteriorating conditions or those at-risk, and to therefore provide timely treatment to these patients. Despite this, there are currently several challenges in identifying rapid-progressors in glaucoma, including lack of consensus on the definition of 'rapid' progression and what rates of change of visual field (VF) encompass clinically significant deterioration relevant to the patients. As such, the Asia Glaucoma Registry is intended to collect data to advance the understanding of glaucoma and its progression in Asia and to understand the management patterns of glaucoma in Asia. The Registry will also provide research data for future collaborative scientific research projects.

NCT ID: NCT05278169 Active, not recruiting - Clinical trials for Central Serous Chorioretinopathy

Central Serous Chorioretinopathy Registry and Pachychoroid Observation and Natural History Study

CSCR POOH
Start date: March 11, 2022
Phase:
Study type: Observational [Patient Registry]

Objectives: 1. To conduct a Natural History Observation Study to characterize the clinical features and progression of Central Serous Chorioretinopathy (CSCR) from the earliest to the vision-threatening stages. 2. Collect genetic samples of affected individuals and their families to establish whether there is a genetic basis for the disease. 3. To create a Registry of patients affected by CSCR who may agree to be contacted for inclusion in future clinical trials. 4. To determine the incidence and risk factors for progression of pachychoroid phenotypes identified from the unaffected fellow eyes of CSCR patients. Design and subjects: Observation, non-interventional study with prospective follow-up for 2 years. The study aims to enroll 350 patients with CSCR (100 from Hong Kong Eye Hospital, 80 from Prince of Wales Hospital and Alice Ho Miu Ling Nethersole Hospital, and 170 from Chinese University of Hong Kong (CUHK) Eye Centre at Hong Kong Eye Hospital). Study instruments: Functional tests include visual acuity and microperimetry. Retinal imaging with non-invasive ultra-widefield colour fundus camera, fundus autofluorescence (FAF) and optical coherence tomography (OCT). Questionnaires for risk factor profiling and quality of life assessment. Blood specimen will be collected for genetic testing if found to have a clinical diagnosis of CSCR as determined at CUHK Eye Centre at Hong Kong Eye Hospital. Main outcome measures: The primary outcome will be longitudinal alteration of retinal pigment epithelium defects on FAF, spectral domain (SD) OCT and infrared imaging. The secondary outcomes are: 1) progressive attenuation of outer nuclear layer (ONL), external limiting membrane (ELM) and ellipsoid zone (EZ) on SD OCT, 2) longitudinal changes of subfoveal choroidal thickness on swept source (SS) OCT, 3) incidence and onset of intraretinal cysts, 4) incidence and onset of type 1 choroidal neovascularization, 5) rate of choriocapillaris non- perfusion on SS OCT angiography (OCTA), 6) rate of loss of retinal sensitivity using microperimetry tests, 7) rate of visual acuity loss, 8) epidemiology of risk factors associated with CSCR, 9) identification of genes and the genetic variants that are associated with susceptibility to CSCR and 10) documentation of the clinical course of serous retinal detachment recurrence(s), persistence and resolution.

NCT ID: NCT05276297 Active, not recruiting - Clinical trials for Hepatitis B, Chronic

A Study on the Safety, Efficacy and Immune Response Following Sequential Treatment With an Anti-sense Oligonucleotide Against Chronic Hepatitis B (CHB) and Chronic Hepatitis B Targeted Immunotherapy (CHB-TI) in CHB Patients Receiving Nucleos(t)Ide Analogue (NA) Therapy

Start date: March 22, 2022
Phase: Phase 2
Study type: Interventional

This study will assess the safety, efficacy and immune response following the sequential treatment of GlaxoSmithKline's (GSK) ASO compound (GSK3228836) and CHB-TI (GSK3528869A) in participants 18 to 65 years stable on NA treatment for CHB. The aim is to quantify the efficacy of sequential therapy as well as to determine an added value of sequential therapy over GSK3228836 therapy in CHB patients treated with NAs. In addition, the study will assess the effect of different treatment durations of GSK3228836 (12 or 24 weeks) prior to initiating GSK3528869A treatment.

NCT ID: NCT05252702 Active, not recruiting - Bradycardia Clinical Trials

Aveir DR i2i Study

Start date: February 2, 2022
Phase: N/A
Study type: Interventional

Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveirâ„¢ Dual-Chamber (DR) Leadless Pacemaker system.