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NCT ID: NCT06141317 Active, not recruiting - Parkinson Disease Clinical Trials

Randomized Clinical Trial in Parkinson's Disease Patients Using Pluripotent Adipose Stem Cells (PASCs)

Start date: June 23, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of allogenic pluripotent stem cells isolated from adipose tissue (PASCs) in patients with Parkinson's Disease.

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: NCT05403567 Active, not recruiting - Clinical trials for Hemiplegic Cerebral Palsy

Video Gaming for Home Rehabilitation for Children With Hemiplegic Cerebral Palsy in Costa Rica

Start date: January 24, 2022
Phase: N/A
Study type: Interventional

Economic and geographic barriers can limit access to rehabilitation therapies for children with cerebral palsy (CP). These barriers are magnified in developing countries like Costa Rica, where 43% of children with disabilities do not have access to basic health services. To address this accessibility gap, effective and engaging approaches are needed to motivate and support children in practicing motor therapies at home. Bootle Blast (BB) is a low-cost, movement-tracking video game that encourages upper limb (UL) exercises at home. BB is mixed-reality; using real-life objects (e.g., toys) in gameplay to target fine motor skills. It is customizable to diverse abilities and therapy goals. BB applies best practices in video game design, theories of motivation and motor learning, to optimize engagement and clinical effectiveness. This mixed-methods study will assess the feasibility of a family-centred BB home intervention among children with hemiplegic CP. The investigators will address four areas of feasibility to 1) Understand the demand for the BB intervention (i.e., expressed interest in the program), 2) Establish probable efficacy for clinical outcomes related to UL function, activity, and participation, 3) Evaluate implementation of the 8-week BB intervention and 4) Explore acceptability (e.g., participants' experiences). Fifteen children with a diagnosis of hemiplegic CP (7-17 yrs) and one of their primary caregivers will participate. This study consists of three phases, each one contributing to the development of the next one. In Phase 1 (demand), recruitment rates and percentage of children with appropriate in-home technology to play will be collected during screening. A pre-intervention interview will explore participants' expectations for the intervention. In Phase 2, study assessments will be performed via videoconference (probable efficacy). Measures will target UL activity and related participation. Children will play BB at home for 8 weeks. Computer-system logs and data from reported technical barriers will be collected (implementation). In Phase 3 parents and children will participate in a post-intervention interview to explore their experiences and perceived value of the BB program (acceptability). Worldwide, children face accessibility barriers to motor therapy services. This study will provide learnings on how therapy gaming interventions can/should be implemented to bridge accessibility gaps, engage children and improve access to care.

NCT ID: NCT05237947 Active, not recruiting - Clinical trials for Human Papillomavirus Infection

Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial

PRISMA
Start date: March 1, 2022
Phase: Phase 4
Study type: Interventional

This phase IV trial tests whether a single dose of the human papillomavirus (HPV) vaccine works in preventing cervical cancer in young women in Costa Rica. Human papilloma viruses, called HPV, are a group of viruses that very frequently cause infection in both men and women, mainly in the genital organs. There are many types of HPV, and some can cause cancer. The World Health Organization recommends a two-dose schedule for adolescents 9-14 and three doses for individuals 15 years old or older. This study examines whether a single dose of HPV vaccine can reduce the frequency with which women between ages 18-30 become infected with HPV.

NCT ID: NCT05171777 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer

A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer

Start date: April 4, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase II, randomized, multi-center, multinational, open-label, cross-over study in adult participants with PD-L1-positive NSCLC. Two populations will be included: participants with resected Stage II, IIIA, and selected IIIB (T3-N2) NSCLC who have completed adjuvant platinum-based chemotherapy without evidence of disease relapse/recurrence, and chemotherapy-naïve participants with Stage IV NSCLC. The study will evaluate participant- and healthcare professionals (HCP)-reported preference for atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV).

NCT ID: NCT05127434 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus

A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age

Start date: November 17, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The main purpose of Part A of this study is to evaluate the safety and tolerability of mRNA-1345 vaccine and to demonstrate the efficacy of a single dose of mRNA-1345 vaccine in the prevention of a first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) as compared with placebo from 14 days postinjection through 12 months. The main purpose of Part B of this study is to evaluate the safety, tolerability and immunogenicity of a booster dose (BD) of mRNA-1345 administered 24 months after the primary dose.

NCT ID: NCT05116241 Active, not recruiting - Clinical trials for Bordetella Pertussis, Whooping Cough

Immunogenicity and Safety of BPZE1 Intranasal Pertussis Vaccine in Healthy School-age Children

Start date: October 28, 2021
Phase: Phase 2
Study type: Interventional

This study evaluates the safety and immunogenicity of the BPZE1 live, attenuated pertussis vaccine, intended to prevent nasopharyngeal colonization and pertussis disease, and compares BPZE1 vaccine vs Boostrix vaccine vs both BPZE1 and Boostrix vaccines. This is a multi-center, randomized, placebo- and active-comparator-controlled study in healthy, school-age children with a 6-month safety follow-up after the first vaccination.

NCT ID: NCT05091437 Active, not recruiting - Pulmonary Nodules Clinical Trials

DOuBLED - Doubling Outcomes by Lung Cancer Early Diagnosis

DOuBLED
Start date: December 30, 2021
Phase:
Study type: Observational

Early diagnosis of LC in the asymptomatic stage through intentional screening programs and/or incidental pulmonary nodule identification and follow-up are known to improve outcomes significantly. There are large gaps in the screening and early detection of LC, especially in LMIC - driven by multifactorial aspects, including a variety of socioeconomic and infrastructural factors, mainly due to limitations in the required network of specialized human resources and technical capacity. Identifying LC at an early stage allows for treatment that is more likely to be curative, thereby improving survival. The present study aims to characterize the lung nodule journey in different hospitals/clinics across Latin America, describing the use of health resources, time to diagnosis, stage at diagnosis, and time to treatment depending on the source of nodule identification in two different cohorts (retrospective and prospective).

NCT ID: NCT04662710 Active, not recruiting - Clinical trials for Advanced/Metastatic Gastroesophageal Adenocarcinoma

Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)

LEAP-015
Start date: December 30, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer. The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants.

NCT ID: NCT04574115 Active, not recruiting - Cataract Clinical Trials

Clinical Investigation of Omega Refractive Capsule, Model VI

ORCVI
Start date: February 6, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the safety and effectiveness of the investigational Omega Refractive Capsule (model VI)