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NCT ID: NCT05465902 Active, not recruiting - COVID-19 Clinical Trials

Safety and Immunogenicity of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) as a Booster

Start date: July 7, 2023
Phase: Phase 2
Study type: Interventional

This is a randomized, phase Ⅱ, single-blind, randomized, parallel-group controlled clinical trial. The study plans to enroll subjects who have completed homologous primary vaccination with either inactivated or mRNA or Viral Vector COVID-19 vaccines (one or two doses) and have not been infected with COVID-19. All subjects will be evaluated for safety and immunogenicity after a single dose booster immunization with Recombinant COVID-19 variant Vaccine (Sf9 Cell) or inactivated COVID-19 vaccine (Vero cell) or mRNA vaccine or Viral Vector vaccine.

NCT ID: NCT05457439 Active, not recruiting - Physical Activity Clinical Trials

Sustainable-psycho-nutritional Intervention Program and Its Effects on Health Outcomes and the Environment

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Mexico is going through a major environmental and nutritional crisis, which is related to unsustainable dietary behaviors. Sustainable diets could solve both problems together. However, in Mexico and the world, an intervention program oriented to promoting sustainable diets has not been designed. This study protocol aims to design a 3-stages, 15 weeks, sustainable-psycho-nutritional digital intervention program whose objective is to promote the adherence of the Mexican population to a sustainable diet and to evaluate its effects on dietary water and carbon footprints, metabolic biomarkers, and gut microbiota of this population. The behavior change wheel model and the guide for digital interventions design will be followed. In stage 1, the program will be designed using the sustainable diets model, and the behavior change wheel model. A sustainable food guide, sustainable recipes, and food plans as well as a mobile application will be developed. In stage 2, the intervention will be carried out for 7 weeks, and a follow-up period of 7 weeks, in a sample of Mexican young adults (18 to 35 years) randomly divided into an experimental group (n=50) and a control group (n=50). The nutritional care process model will be used. Anthropometric, biochemical, clinical, dietary, environmental, socioeconomic level and cultural aspects, nutritional-sustainable knowledge, behavioral aspects, and physical activity will be considered. Thirteen behavioral objectives will be included using successive approaches in online workshops twice a week. The population will be monitored using the mobile application that will include behavioral change techniques. In stage 3, the effects of the intervention will be assessed on the dietary water and carbon footprint, lipid profile, serum glucose, and gut microbiota composition of the evaluated population. It is expected to find improvements in health outcomes and a decrease in dietary water and carbon footprints. With this study, the first theoretical-methodological approach to the sustainable-psycho-nutrition approach will be generated.

NCT ID: NCT05433584 Active, not recruiting - Type 2 Diabetes Clinical Trials

A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes

SURPASS-EARLY
Start date: August 1, 2022
Phase: Phase 4
Study type: Interventional

This study aims to investigate the efficacy and safety of tirzepatide in participants with type 2 diabetes (T2D) compared to other existing treatment options when treatment is initiated early.

NCT ID: NCT05421598 Active, not recruiting - Asthma Clinical Trials

Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma

TIDE-asthma
Start date: June 30, 2022
Phase: Phase 2
Study type: Interventional

This is a parallel, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study for treatment. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with amlitelimab in adult participants with moderate-to-severe asthma. Study details include: - The study duration (per participant) will be up to approximately 76 weeks for participants not going into LTS study and will be up to approximately 64 weeks for participants going into LTS study. - The randomized treatment duration will be up to approximately 60 weeks. - The scheduled number of visits will be 13.

NCT ID: NCT05415215 Active, not recruiting - Clinical trials for Locally Advanced Breast Cancer

A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer

ProHer
Start date: July 5, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase IIIb, multinational, multicenter, randomized, open-label study to evaluate patient preference of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) administration in the home setting compared with the hospital setting during the cross-over period of adjuvant treatment in participants with early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer.

NCT ID: NCT05402371 Active, not recruiting - NAFLD Clinical Trials

A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver Fibrosis

ASCEND
Start date: October 15, 2022
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-dosing, multi-center study to evaluate the efficacy and safety of Rencofilstat as evidenced by histopathological improvements in fibrosis in adult NASH subjects with F2 or F3 fibrosis (NASH CRN system). Antifibrotic biomarker activity will be evaluated on an exploratory basis.

NCT ID: NCT05377463 Active, not recruiting - HIV Viremia Clinical Trials

Optimizing a Bio-behavioral Intervention for Sustained Viral Suppression

Start date: May 10, 2023
Phase: N/A
Study type: Interventional

The study will test four behavioral intervention components to identify the combination of the four components that best supports people who inject drugs to achieve and sustain HIV viral load suppression. The study design is a 2-to-the-4 factorial experiment. The 2 represents the level of each component: 0 (receive) or 1 (don't receive). The 4 represents the number of components being tested. The four components are: 1) receiving (or not receiving) peer support services for medication-assisted treatment (MAT) uptake and persistence, 2) behavioral activation therapy for depression (BAT), 3) Life-Steps Program for medication adherence, and 4) patient navigation for HIV care. Therefore, in order to test which combination of components produce the best outcome, this factorial design randomizes people to 1 of 16 conditions. Each condition represents a possible combination of the 4 components above.

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: NCT05361668 Active, not recruiting - Carcinoid Tumor Clinical Trials

Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome

Start date: June 17, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and exploratory dose response of paltusotine treatment in subjects with carcinoid syndrome. This study consists of a Randomized Treatment Phase followed by an Open-Label Extension (OLE) Phase.

NCT ID: NCT05350072 Active, not recruiting - Sjogren Syndrome Clinical Trials

Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

NEPTUNUS-1
Start date: July 28, 2022
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-1)