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NCT ID: NCT06324383 Recruiting - Depression Clinical Trials

Enhancing Purpose and Well-Being Through a Volunteering Experience Connecting Veterans With English Language Learners

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to refine and test a strategy for engaging Veterans with symptoms of depression, anxiety, and/or PTSD (Post Traumatic Stress Disorder) as volunteers to help English language learners (ELLs) improve their speaking skills via structured conversations using videoconferencing.

NCT ID: NCT06324357 Recruiting - Clinical trials for Metastatic Breast Cancer

Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib in Combination With Trastuzumab Deruxtecan or With Trastuzumab Emtansine and to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread

Start date: May 23, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken together with trastuzumab deruxtecan (T-DXd) or with trastuzumab emtansine (T-DM1). Another purpose is to check whether zongertinib in combination with T-DXd or with T-DM1 can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow. The study is split into treatment cycles. All study participants are treated with zongertinib in combination with T-DXd or with T-DM1. This study has 2 parts. In Part 1, participants receive increasing doses of zongertinib. In Part 2, participants are put into different groups by chance. Each group receives a different dose of zongertinib. Every participant has an equal chance of being in each group. During the study, the participants visit the study site regularly. In this study, researchers want to find the highest dose of zongertinib that participants can tolerate when taken together with T-DXd or with T-DM1. To find this out, researchers look at certain severe health problems that a number of participants have. The doctors regularly check the size of the tumour with imaging methods (CT/MRI) during the study. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT06324344 Recruiting - Pain Clinical Trials

Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN)

Start date: October 2, 2023
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to examine the acceptability and proof of concept effectiveness of a wireless Transcutaneous Electrical Nerve Stimulation (TENS) technology to address Chemotherapy Induced Peripheral Neuropathy (CIPN). Participants, who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 1:1 into two groups. The patients and clinicians will be blinded for group allocation. One group will utilize TENS high-dose devices (Intervention group, IG); the other group will utilize low-dose TENS devices (Placebo group, PG). The baseline measurements will be performed, and the patients will take the programmed device home for a duration of 8 weeks. Then, the patients will come back after four weeks (4W) and after 8 weeks (8W) for outcome assessment. The primary outcome will be pain. Secondary outcomes include: nerve conduction and velocity, vibration perception threshold, quality of life. Exploratory outcomes include gait assessment (gait speed, stride length, double stance, and gait steadiness), and balance.

NCT ID: NCT06324318 Recruiting - Parenting Clinical Trials

Parenting in 2 Worlds Multisite Trial

(P2W)
Start date: September 14, 2023
Phase: Phase 2
Study type: Interventional

This research study will test the effectiveness of a culturally grounded parenting intervention called Parenting in 2 Worlds (P2W). This intervention is designed for American Indian / Alaska Native (AI) parents/guardians of adolescents who reside in urban areas. This will be a multi-regional effectiveness trial across four regions: Northeast (Buffalo/Niagara), Midwest (St. Paul/Minneapolis), Mountain (Denver), and Southwest (Phoenix). There are four specific aims. First, this study will test the effectiveness of Parenting in Two Worlds (P2W) as compared to an informational family health intervention, Healthy Families in 2 Worlds (HF2W), in improving parenting and family functioning. Second, this study will test if the relative effectiveness of P2W, compared to HF2W, varies by parent's/guardian's level of socioeconomic vulnerability, experiences of historical loss, or AI cultural identity. Third, this study will examine if P2W can reduce adolescent (ages 12 - 17) risky health behaviors including substance use, depressive symptoms, suicidality, and risky sexual behaviors. Fourth, this study will examine whether positive changes in parenting and family functioning that result from P2W lead to positive changes in adolescent's health behaviors.

NCT ID: NCT06324201 Recruiting - Clinical trials for Paroxysmal Atrial Fibrillation

The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation.

QDOT PAS
Start date: February 27, 2024
Phase:
Study type: Observational

Observational, multi-center, non-randomized, post-market study. This is a nested sub-study of the REAL AF Registry. Consecutive symptomatic drug refractory paroxysmal atrial fibrillation (PAF) patients from the registry will be screened for enrollment to this sub-study per inclusion and exclusion criteria.

NCT ID: NCT06323967 Recruiting - Family Well-being Clinical Trials

Growing Strong Study of Unconditional Cash Transfers Plus Peer Support for Families With Babies in Homeless Shelters

Start date: May 21, 2024
Phase: N/A
Study type: Interventional

The Growing Strong program tests a novel approach to helping families with young children living in homeless shelters, namely offering guaranteed, unconditional cash gifts that families can use as they wish plus voluntary peer support. The assumption behind this approach is that families know best how to allocate resources to meet their own individual needs. While there are a number of Direct Cash Transfer studies taking place around the country, the investigator(s) are unaware of any that have tested the relationship of receiving cash on homelessness among families specifically. To be eligible to participate in the study, families must reside in a homeless shelter and have at least one child under two years of age living with them in shelter. The investigator(s) have tied eligibility to the age of the youngest child in the household because rates of shelter use are highest among this population and because the costs associated with young children increase such families' financial burdens. A total of 200 families will be enrolled in the study. One hundred families in the active intervention group will receive $1,500 per month ("substantial cash") for 24 months ($18,000 annually) and may also elect to receive peer support services. One hundred families in the active comparison group will receive $50 per month ("nominal cash") for 24 months ($600 annually) and will not have access to the peer support services. A third, passive comparison group will receive usual care within the homeless shelter system in the same metropolitan area (New York City) as participants in both cash gift groups. This group of families will be followed only in administrative records. The main research questions are: does providing substantial, unconditional cash transfers plus access to voluntary peer support services over 24 months a) reduce the length of time in shelter for families with young children and/or b) improve other aspects of family and child well-being relative to providing nominal cash transfers alone or usual care.

NCT ID: NCT06323928 Recruiting - Migraine Clinical Trials

A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments

PROCEED
Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to determine which doses of Lu AG09222 are recommended to help prevent migraines. People who join this trial have already tried 2 to 4 other available medications to prevent their migraines, but these medications have not helped them.

NCT ID: NCT06323850 Recruiting - Autism Clinical Trials

Improving Access to Community-Based Occupations Via a Rideshare Training Program

Start date: June 15, 2024
Phase: Early Phase 1
Study type: Interventional

Community mobility is critical for living independently and engaging in one's community. It is especially important for people in their early adult years, as this is often a time of transition to employment and living independently. Community mobility can be particularly challenging for adults with Autism Spectrum Disorders (ASD) (henceforth referred to as autistic adults based on the preferred identity-first language of our autistic partners). Some autistic adults are unable to meet the demands of driving. Public transportation is an option for autistic adults; and autistic adults are more likely to use public transportation than their non-autistic counterparts. However, using public transportation may be just as challenging as driving for the autistic population. Rideshare (also called ride-hailing) is a relatively new form of transportation in which passengers get from point A to point B in private vehicles driven by their owners. A digital app, usually accessed on a smartphone, matches passengers and drivers, coordinates routes using a GPS system, and facilitates payment through a linked financial account. Rideshare has the potential to address many of the issues autistic adults have accessing the community. It is faster and more direct than the public train or bus, there is limited social interaction required, and rides can be scheduled at any time. Despite it's potential to increase transportation in autistic adults, there are no evidence-based training programs to support Rideshare use in this population.

NCT ID: NCT06323824 Recruiting - Opioid Use Disorder Clinical Trials

Office-based Methadone Versus Buprenorphine to Address Retention in Medication for Opioid Use Disorder Treatment.

Start date: June 4, 2024
Phase: Phase 4
Study type: Interventional

The purpose of this clinical trial is to compare the effectiveness of office-based methadone with pharmacy administration and/or dispensing to office-based buprenorphine for the treatment of opioid use disorder. This study will also examine factors influencing the implementation of office-based methadone.

NCT ID: NCT06323590 Recruiting - Clinical trials for Acute Myeloid Leukemia

Refining the Role of Mid-induction Bone Marrow Biopsy in Acute Myeloid Leukemia: A Pilot Study

Start date: May 2, 2024
Phase:
Study type: Observational

The purpose of the study is to observe the outcomes of patients with acute myeloid leukemia who do not receive an immediate second round of chemotherapy after undergoing a standard mid-induction bone marrow biopsy.