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NCT ID: NCT06411366 Completed - Aging Clinical Trials

Phase I: Safety and Efficacy of an Injectable Follistatin Plasmid Gene Therapy in Humans

Start date: August 18, 2022
Phase: Phase 1
Study type: Interventional

This study examines the safety and effects of an injectable plasmid gene therapy. Plasmids are circular pieces of DNA which have been widely studied as a non-permanent & non-heritable method for transferring genes and inducing gene expression. In this study the plasmid is a gene vector which contains the human FST344 gene intended to express and secrete bioidentical human follistatin into serum circulation. Follistatin is a myostatin and activin inhibitor that has demonstrated improved functional outcomes in mouse models of neuromuscular disease. Participants will undergo dual energy x-ray absorptiometry scans before and after the treatment's administration to compare change from baseline and rates of change in fat vs muscle tissue and bone density. Participants will also undergo metabolic and epigenetic blood panels to observe any changes. Participants will be monitored at the clinic site for a short time period after receiving the therapy and participants will be able to report any adverse events through an online form. Lastly, participants will have blood drawn just prior to, and three months after, the gene therapy's administration in order to assess circulating levels of follistatin. This study is administered at the Global Alliance for Regenerative Medicine clinical research site on the island of Roatan and is sponsored by Minicircle. The main contact for this study is Mac Davis.

NCT ID: NCT06363201 Not yet recruiting - Sarcoma Clinical Trials

Effect and Safety of Ocoxin Oral Solution on the Quality of Life of Paediatric Patients With Advanced Stage Solid Tumours

Start date: April 28, 2024
Phase: N/A
Study type: Interventional

Exploratory study to evaluate the effect and safety of the use of Ocoxin® oral solution on the quality of life of paediatric patients with advanced stage solid tumours.

NCT ID: NCT06279871 Active, not recruiting - COVID-19 Clinical Trials

Immunogenicity and Safety Study of Self-amplifying mRNA COVID-19 Vaccine Administered With Influenza Vaccines in Adults

Start date: March 27, 2024
Phase: Phase 3
Study type: Interventional

This is a multicenter, observer-blind, randomized, controlled phase 3 study to evaluate the immunogenicity, reactogenicity, and safety of an investigational self-amplifying RNA COVID-19 vaccine (ARCT-2303) administered concomitantly with quadrivalent influenza vaccines or standalone in adults who previously received authorized COVID-19 vaccine.

NCT ID: NCT06252285 Recruiting - RSV Immunisation Clinical Trials

Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers

PEARL
Start date: February 6, 2024
Phase: Phase 3
Study type: Interventional

This study is a phase III, randomized, observer-blind, placebo-controlled, multinational, multi-center study to be conducted in approximately 6300 children 6 months to < 22 months of age. The purpose of the study is to evaluate the efficacy, immunogenicity, and safety of Respiratory Syncytial Virus Toddler (RSVt) vaccine administered by intranasal route compared to placebo. Eligible participants will be randomized in a 1:1 ratio to receive 2 intranasal administrations of either the RSVt vaccine or placebo. Study duration will be 24 months for each participant. The safety follow-up will start after the first vaccination and up to the end of the study.

NCT ID: NCT06251024 Recruiting - Healthy Volunteers Clinical Trials

Study of a Respiratory Syncytial Virus Candidate Formulation in Adults Aged 60 Years and Older

Start date: April 2, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this Phase IIb study is to evaluate the efficacy of the RSV vaccine candidate for the prevention of lower respiratory tract disease (LRTD) due to RSV. The study will enroll approximately 4500 adults aged 60 years and older in a 1:1 ratio to receive a single intra-muscular (IM) administration of either a pre-determined dose of the RSV vaccine candidate or placebo.

NCT ID: NCT06223191 Active, not recruiting - Clinical trials for Substance Use Disorders

Reducing Readmissions: BNI Trial in Substance Use Disorder

Start date: January 29, 2024
Phase: N/A
Study type: Interventional

The aim of this clinical trial is to assess the effectiveness of Brief Negotiated Interview (BNI) in comparison to Narrative Therapy and Standard Care in reducing readmissions among male patients aged 18 and above with a history of substance use disorder The main questions it aims to answer is: Does the Brief Negotiated Interview reduces rehospitalization rates at least to 50%? Participants will be submitted to a Structured interview with motivational interviewing techniques. Researchers will compare 2 control groups one with standards of care and the other one with a narrative interview to see if they reduce readmission.

NCT ID: NCT06164613 Recruiting - Clinical trials for Labor Onset and Length Abnormalities

Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial

CINNALAB
Start date: December 4, 2023
Phase: Phase 2
Study type: Interventional

The purpose of the research protocol is to evaluate the effectiveness of Cinnamomum verum extract for the initiation of labor. Cinnamaldehyde ((E)-3-Phenylprop-2-enal) is an α, β unsaturated aromatic aldehyde, derived from cinnamon (Cinnamomum Verum oil) used as a flavoring; It is a clear yellowish liquid substance, with a strong odor and flavor. It is the main component of cinnamon (63%), giving it its physicochemical properties. Cinnamon has been an element of empirical use for the beginning of labor, however, its effectiveness has not been demonstrated. Cinnamon has been reported for its ethnopharmacological properties in pregnancy, being used to facilitate childbirth, as a lactagogue and for postpartum recovery. In Honduras, its use has been reported to relieve nausea and vomiting during pregnancy, to reduce abdominal pain. , reduction of lower limb edema, to relieve anxiety during labor, as well as a lactagogue without convergent opinions.

NCT ID: NCT06106581 Recruiting - Clinical trials for Chikungunya Virus Infection

A Phase 2 Clinical Study of VLA1553 in Healthy Children Aged 1 to 11 Years

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

This is a multicenter, prospective, randomized, observer-blinded, three arm, phase 2 clinical trial evaluating the full dose formulation of VLA1553, half dose formulation of VLA1553 and control. At least 300 male and female healthy children aged 1 to 11 years will be enrolled and the overall distribution of participants will be 2:2:1 to the two VLA1553 dose groups (n=120 each) or control (n=60).

NCT ID: NCT05964582 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus Infections

Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and Toddlers

Start date: July 11, 2023
Phase:
Study type: Observational

The study is a multi-center, multi-national, prospective surveillance study in which the study participants will not receive a study vaccine but will provide a baseline blood sample and be followed for acute respiratory disease during 6 months. The 6-month follow-up will occur for the most part during the Respiratory Syncytial Virus(RSV) season (based on enrollment timing and as per feasibility). A maximum of 1000 children from 6 to < 22 months of age are planned to be enrolled in 5 to 10 countries, 1 to 2 sites per country, targeting approximately 100 participants per country. The purpose of the study is to assess the seroprevalence and incidence of RSV disease during the study period in the targeted countries and sites for a Phase III vaccine study.

NCT ID: NCT05929976 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia

InterNatIonal CHildhood Leukemia Microbiome/MEtabolome Cohort

NICHE
Start date: October 26, 2022
Phase:
Study type: Observational

Nutritional status is a measurable and modifiable factor that is often not considered during treatment and its clinical impact undervalued due in part to the heavy demands on clinicians in low and middle income countries to deliver therapy to large numbers of patients. The proposed study will create a biobank of clinical data and biological specimens which will foster future studies on cancer progression and prognosis as well as toxicities during treatment which may impact survivorship and late-effects. Eligible patients must be between 3 years and 18 years of age at time of assent/consent, have newly diagnosed B- or T-cell acute lymphoblastic leukemia or mixed phenotype acute leukemia confirmed by pathology report, and must be receiving treatment at one of the participating centers. Patients receiving hematopoietic cell transplant will be excluded. Institutions were selected to ensure representation of several global health indicators related to nutritional status and wealth classification according to the World Bank. Data related to demographic variables (socioeconomic status, food security), lifestyle habits (diet, physical activity), nutritional anthropometrics (height, weight and arm anthropometry), and nutritional biological indices (stool and blood) will be collected at designated timepoints throughout treatment and one year after the end of treatment.