Clinical Trials Logo

Filter by:
NCT ID: NCT06276556 Enrolling by invitation - Gout Clinical Trials

Extension Study of ABP-671 in Participants With Gout

Start date: April 22, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objectives of this study are to assess the safety, tolerability, and efficacy of ABP-671 in lowering serum uric acid (sUA) in participants with gout who roll over from Study ABP-671-301 after they complete the double-blind 28-week Treatment Period of Part 1 (Phase 2b) or Part 2 (Phase 3).

NCT ID: NCT06195358 Recruiting - Infant Development Clinical Trials

Mobile Health Intervention for Infants in Guatemala (18-m Intervention)

Start date: January 25, 2024
Phase: N/A
Study type: Interventional

Promoting optimal development for children at risk in low- and middle-income countries (LMICs) is an important global health priority. Supporting caregivers to provide nurturing care is an evidence-based strategy, however feasibility of scaling-up this supporting is limited by competing demands on health workers' time. For infant development, mHealth technologies have the potential to solve this problem by providing tailored content directly to caregivers, involving and empowering them to promote infant development, promoting and facilitating interactions with health workers when areas of concern are identified and, therefore, expanding the reach of healthcare systems. Following a pilot feasibility study, this current study will examine the effectiveness of a caregiver-directed smartphone application to directly engage first-time caregivers in rural Guatemala and support early childhood development.

NCT ID: NCT06186206 Not yet recruiting - Vaccine Hesitancy Clinical Trials

Culturally and Linguistically Appropriate Vaccine Education

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

The goal of this clinical trial is to test the effectiveness of culturally tailored social media campaigns and WhatsApp-based vaccine training for healthcare workers in increasing childhood routine and HPV vaccine confidence and uptake in mainly indigenous rural communities in Guatemala. Main Research Questions: - Does a culturally tailored social media campaign, deployed via Facebook and geographically targeting randomly assigned communities, increase childhood routine and HPV vaccine confidence and uptake in mainly indigenous rural communities in Guatemala? - Does WhatsApp-based vaccine training for community healthcare workers increase vaccine uptake in these communities? Participants in this study will be involved in the following tasks: Community Healthcare Worker WhatsApp Training: Community healthcare workers will participate in WhatsApp training sessions to enhance their knowledge and skills related to vaccine education and communication. Pre-Post Surveys: Surveys will be collected from individuals who are caretakers of children under 5 recruited from local health facilities. A total of 600 people will participate in the surveys (200 from each study arm and 200 pre-intervention). Surveys will be conducted in Spanish, K'iche', and Kaqchikel languages to compare vaccination uptake, hesitancy, and barriers/facilitators of vaccination. Researchers will compare the groups receiving the social media campaign and WhatsApp training to those with no intervention to determine the effects on childhood routine and HPV vaccine confidence and uptake in indigenous rural communities in Guatemala.

NCT ID: NCT06136650 Recruiting - Prostatic Neoplasms Clinical Trials

A Study of MK-5684 Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

Start date: December 18, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of MK-5684 plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypotheses are that MK-5684 is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and overall survival (OS), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

NCT ID: NCT06080451 Enrolling by invitation - Hypertension Clinical Trials

Implementing HEARTS in Guatemala

Start date: October 3, 2023
Phase: N/A
Study type: Interventional

The HEARTS Technical Package was developed by the World Health Organization to address the implementation gap of cardiovascular disease prevention in low- and middle-income countries. Guatemala is a middle-income country that is currently implementing HEARTS. National authorities are interested in exploring how hypertension and diabetes management can be integrated in HEARTS implementation. The objective of this study is to conduct a feasibility and acceptability pilot trial of integrated hypertension and diabetes management based on HEARTS in the publicly funded primary care system in Guatemala.

NCT ID: NCT06065748 Recruiting - Clinical trials for Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

Start date: December 11, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

NCT ID: NCT05985915 Recruiting - Sjogrens Syndrome Clinical Trials

A Randomized, Double-blind 2-arm NEPTUNUS Extension Study to Assess the Long-term Safety and Efficacy of Ianalumab in Patients With Sjogrens Syndrome.

NEPTUNUS-Ext
Start date: October 27, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the long-term safety and tolerability of ianalumab in participants with Sjogrens syndrome who have previously completed treatment from one of two NEPTUNUS 1 year core studies (CVAY736A2301 or CVAY736A2302). - The study treatment is ianalumab 300 mg in a 2 mL pre-filled syringe for injection. All participants will receive ianalumab either monthly or every 3 months. - The treatment duration will be 3 years with an additional up to 2-year safety follow-up. The total duration of this extension study will be up to 5 years. - The visit frequency will be monthly during both the treatment period and mandatory follow-up, and then less frequently during the subsequent conditional follow-up Treatment of interest: The randomized treatment (ianalumab) will be received monthly or every 3 months. Participants assigned to treatment every 3 months will receive placebo every month between the ianalumab doses to maintain blinding. Number of Participants: Approximately 600 participants from the NEPTUNUS core studies will be rolled over into the extension study. Treatment Groups:There will be no screening period in this trial. From Week 48 of the NEPTUNUS core study, participants will be given the opportunity to consent to this extension study. From Week 52 of the NEPTUNUS core studies (i.e., Day 1 in the extension study), eligible participants will be assigned to either one of the treatment regimens: - ianalumab 300 mg monthly or - ianalumab 300 mg once every 3 months Participants receiving placebo in either of the NEPTUNUS core studies will be randomized 1:1 to receive ianalumab 300 mg monthly or every 3 months starting from Week 60 and participants receiving ianalumab in either of the NEPTUNUS core studies will continue the same treatment in the extension study. Ianalumab will be given as a subcutaneous injection from a 2 mL pre-filled syringe. Participants will be given the opportunity to self-inject at home on some visits after receiving training.

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.

NCT ID: NCT05818085 Recruiting - Gout Clinical Trials

Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout

Start date: August 11, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, Phase 2b/3 study to evaluate the efficacy and safety of ABP-671. Part 1 of the study will compare the efficacy and safety of different doses and regimens of ABP-671 with placebo and allopurinol. Part 2 of the study will compare the dosing regimen(s) of ABP-671 selected from Part 1 with placebo in participants who have not been enrolled for Part 1.

NCT ID: NCT05781750 Recruiting - Lupus Nephritis Clinical Trials

A Study of Zetomipzomib (KZR-616) in Patients With Active Lupus Nephritis (PALIZADE)

Start date: November 3, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of zetomipzomib (30 mg or 60 mg) compared with placebo in achieving renal response after 52 weeks of treatment in patients with active lupus nephritis (LN).