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NCT ID: NCT05952557 Recruiting - Clinical trials for Breast Cancer, Early Breast Cancer

An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

CAMBRIA-2
Start date: October 5, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.

NCT ID: NCT05948787 Enrolling by invitation - Family Relationship Clinical Trials

Assessing the Feasibility of Providing a Family Skills Intervention "Strong Families" for Families in the Philippines.

SF_RCT_POPHL
Start date: February 28, 2023
Phase: N/A
Study type: Interventional

The Strong Families Programme was introduced by UNODC in the Philippines in 2018 through the training of facilitators. Twenty-six participants trained in the program from different cities and municipalities. Afterward, Caloocan, Marikina, Palawan, Pasig, and Quezon City Local Government Units (LGUs) started to train more facilitators to allow them to pilot the program in their communities. Eventually, these cities and municipalities managed to engage families to benefit from the Strong Families Programme. The current study aims to explore the feasibility, effectiveness and acceptability of this universal prevention program with families in the Philippines, and the feasibility of delivering the program. The primary objective will be to test the effectiveness of the Strong Families program in improving family skills outcomes and caregiver and child mental health, as reported by caregivers, when implemented in the Philippines. The secondary objective will be to calculate the extent of family's attendance of Strong Families sessions, to evaluate completeness of program delivery. The tertiary objective will be to explore the cultural and contextual acceptability of the Strong Families program for families in the Philippines. A two-arm feasibility Randomized Controlled Trial with two arms: 1) Implementation of Strong Families (Intervention Group) and 2) Wait list/Control (Services-as-usual). This trial will have an embedded process evaluation. This study will take place in five locations in the Philippines. The implementation usually happens at the Barangay Level (The smallest administrative division in the Philippines and is the native Filipino term for a village, district, or ward)

NCT ID: NCT05941052 Recruiting - Tuberculosis Clinical Trials

Assessing Diagnostics At Point-of-care for Tuberculosis

ADAPT
Start date: August 28, 2023
Phase: N/A
Study type: Interventional

Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide. The Assessing Diagnostics At Point-of-care for Tuberculosis (ADAPT) study seeks to reduce the burden of TB worldwide by evaluating faster, simpler, and less expensive TB triage and diagnostic tests.

NCT ID: NCT05926440 Withdrawn - COVID-19 Clinical Trials

Immunogenicity and Safety Study of SCB-2023 Vaccine as a Booster in Adults

Start date: August 17, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the immunogenicity and safety of SCB-2023 trivalent vaccine compared to the prototype SCB-2019 monovalent vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.

NCT ID: NCT05904470 Recruiting - Hepatitis C Clinical Trials

A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic HCV

Start date: May 30, 2023
Phase: Phase 2
Study type: Interventional

This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic HCV infection.

NCT ID: NCT05875961 Recruiting - Clinical trials for Respiratory Tract Infections

Study to Evaluate Immunogenicity, Safety and Tolerability of Adjuvanted and Non-Adjuvanted H2N3 Influenza Vaccines in Adults

Start date: June 15, 2023
Phase: Phase 1
Study type: Interventional

This Phase 1, randomized, observer-blind, dose-ranging clinical study is evaluating 6 different formulations of MF59-adjuvanted and non-adjuvanted H2N3 influenza vaccine. Approximately 600 healthy adult subjects are to be randomized into 1 of 6 possible treatment groups with 100 subjects per group, stratified by age group (born after or before 1968). Each subject will receive an influenza vaccine injection on Day 1 and Day 22. Subjects will be followed up for approximately 12 months after the second vaccine injection. The primary immunogenicity analysis is based on the Day 1, Day 8, Day 22, Day 29, and Day 43 serology data. The primary safety analysis is based on solicited local and systemic adverse events (AEs) reported within 10 days after each vaccination, unsolicited AEs reported within 3 weeks after each vaccination, and serious AEs (SAEs), medically attended AEs (MAAEs), AEs leading to withdrawal from the study, and AEs of special interest (AESIs) reported throughout the study.

NCT ID: NCT05819398 Recruiting - Clinical trials for Hidradenitis Suppurativa

Lunsayil 1: A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa

Start date: April 10, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This study is open to adults with moderate to severe hidradenitis suppurativa (HS). The purpose of this study is to find out whether a medicine called spesolimab helps people with HS. People who have previously taken specific medicines such as immunosuppressive biologics other than Tumor necrosis factor (TNF) inhibitors cannot take part. This study has 2 parts. In Part 1, participants are divided into 4 groups of almost equal size. 3 groups get different doses of spesolimab, 1 group gets placebo. All participants get injections into a vein or under the skin. Placebo injections look like spesolimab injections, but do not contain any medicine. Every participant has an equal chance of being in each group. In the beginning, participants get the study medicine every week and later every 2 weeks. After 4 months, participants in the placebo group switch to spesolimab treatment. In Part 2, participants are divided into 2 groups. One group gets a suitable dose of spesolimab that was found in Part 1 of the study. The other group gets placebo. After 4 months, participants in the placebo group switch to spesolimab treatment. Participants join only one of the two parts. They are in the study for about 1 year. During this time, they visit the study site in the beginning every week and later every 2 weeks. Some of the visits can be done at the participant's home instead of the study site. The doctors regularly check participants' HS symptoms. The results are compared between the groups to see whether spesolimab works. The doctors also regularly check participants' general health and take note of any unwanted effects.

NCT ID: NCT05809934 Active, not recruiting - Clinical trials for Nonalcoholic Steatohepatitis

A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

FORTUNA
Start date: March 15, 2023
Phase: Phase 2
Study type: Interventional

A Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 given by subcutaneous injection in adult participants with non-cirrhotic non-alcoholic steatohepatitis with fibrosis and who are carriers of the PNPLA3 148M Risk Allele

NCT ID: NCT05801380 Recruiting - Alzheimer Disease Clinical Trials

Monitoring Drug Efficacy in Patients With Alzheimer's Disease

MEMORI-AD
Start date: February 14, 2022
Phase:
Study type: Observational

This study will explore the different factors associated with drug response to acetylcholinesterase (AChE) inhibitor (donepezil) and NMDA receptor antagonist (memantine) in patients with Alzheimer's Disease.

NCT ID: NCT05797766 Completed - Clinical trials for End-stage Renal Disease

Efficacy Trial of Fluid Distribution Timetable

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

Nonadherence to fluid restriction is a significant issue among hemodialysis patients globally, with numerous adverse health outcomes. These outcomes include increased intradialytic weight gain, acid-base and electrolyte imbalances, and decreased mental health. This study aimed to determine the effects of a fluid distribution timetable on adherence to fluid restriction among patients with end-stage renal disease undergoing hemodialysis. The study utilized a single-blind, randomized-controlled efficacy trial design. Selected ESRD patients undergoing hemodialysis are then randomized using computer-generated sequences of randomly permuted blocks stratified according to sex to receive the intervention or the control group. Adherence to fluid restriction was measured using the dialysis thirst inventory and intradialytic weight gain. The variables were computed using One-way Repeated Measures Multivariate Analysis of Variance and Multivariate Analysis of Covariance. Secondary outcomes included baseline patient demographic profile and was compared according to group allocation. Both group were followed up for four weeks, assessing the outcome measures during the third hemodialysis session for each week