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NCT ID: NCT06229392 Recruiting - Breast Cancer Clinical Trials

A Study to Evaluate the Intratumoral Influenza Vaccine Administration in Patients With Breast Cancer

Start date: February 28, 2024
Phase: Phase 1
Study type: Interventional

This Phase 1 study will assess the safety and efficacy (usefulness) of administering 2 doses of seasonal flu vaccine directly into breast cancer tissue (primary tumor), and will study the tumor and whole body response to the vaccine. If the tumor is palpable (able to fee by touch), the vaccine will be administered by a Surgeon/oncologist in the outpatient floor - both experienced and trained. If not palpable, the procedure will be done via guided Ultrasound by our Breast Radiologist -- both experienced and trained. Women with triple-negative (TNBC) and HER2+ types of breast cancer will be eligible for enrollment. Up to 18 subjects may be enrolled at Rush. Successive groups of 3 subjects per breast cancer type will be given increasing doses of vaccine. There are 3 potential dosing groups (half-dose, full dose, and high dose). Blood, stool (optional), and tumor tissue samples will be collected and tested. The active participation period is from one week prior to starting chemotherapy through three months post surgery.

NCT ID: NCT06229353 Not yet recruiting - Clinical trials for Human Papilloma Virus

Developing and Evaluating a Novel Approach to Improve HPV Vaccination Coverage Among High-risk, Under-immunized Adults Via the Emergency Department

Start date: September 2024
Phase:
Study type: Observational

To determine if the emergency department (ED) setting offers a viable space for improving HPV vaccination coverage among 18 to 45-year-old adults who have not yet received human papilloma virus (HPV) vaccination or who did not complete the vaccine series. This study will develop, pilot and evaluate an ED-based HPV vaccination protocol and program for ED patients aged 18-26 (for whom catch-up HPV vaccination is routinely recommended by the CDC) and separately for patients aged 27-45 (for whom it may be recommended under shared decision making, SDM).

NCT ID: NCT06229262 Not yet recruiting - Cognition Clinical Trials

Immune and Cognitive Benefits of Mango Intake in Young Adults

Start date: June 2024
Phase: N/A
Study type: Interventional

The main objectives of our proposed study are to determine the effects of mango consumption on immune and cognitive functions in free-living college going young adults aged 18-30 years

NCT ID: NCT06229236 Recruiting - Clinical trials for Diabetes Mellitus, Type 1

Assessing Effectiveness of a Diabetes Navigator in Increasing Progression of Advanced Diabetes Technologies

IMPACT-T1D
Start date: February 13, 2024
Phase: N/A
Study type: Interventional

The goal of this randomized control trial is to determine if the support of a Diabetes Navigator is more effective than standard care in improving uptake and use of advanced diabetes technology among patients with type 1 diabetes.

NCT ID: NCT06229223 Recruiting - Suicidal Ideation Clinical Trials

Improving Screening and Follow Up for Suicidal Ideation and Behaviors Among Latinx Youth in Primary Care

Start date: March 26, 2024
Phase: N/A
Study type: Interventional

The objective of this proposal is to develop and pilot a systems-level strategy in pediatric primary care to enhance identification and management of suicidal ideation and behavior in Latinx youth, particularly those in immigrant families with parents who have limited English proficiency (LEP). The investigators will focus on the use of trained community health workers (CHWs) to increase clinic capacity and quality of suicide risk screening and early intervention, with a focus on safety planning, parent psychoeducation and care coordination. Specific aims are 1: To develop site-specific implementation protocols for the integration of CHWs into SIB screening and safety planning for Latinx youth and the youths families; 2: To pilot the implementation of the program in a six-month open trial in four pediatric primary care practices representing a range of usual practice settings; and 3: To engage a stakeholder network to explore barriers and facilitators, including costs and billing strategies, to implementation of this approach across a broad range of pediatric primary care settings. Parents/guardians of youth who have been referred to and agree to participate in the intervention by the child's primary care provider will participate in a 2-month program consisting of 6-8 phone sessions with a community health worker focusing on safety planning, information/education, program solving and self-care. Research participants will be asked to complete a survey via phone at the beginning of the program and another at the end of the program. The participants may also be asked to participate in an additional interview about the study.

NCT ID: NCT06229210 Recruiting - Schizophrenia Clinical Trials

Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia or Bipolar Disorder

Start date: January 25, 2024
Phase: Phase 3
Study type: Interventional

This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia or bipolar disorder.

NCT ID: NCT06229145 Recruiting - Gout Clinical Trials

A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout

Start date: January 22, 2024
Phase: Phase 4
Study type: Interventional

The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase Q4W with MTX, in participants with uncontrolled refractory gout. The main objective of the study is to evaluate the effect of pegloticase 16 mg administered Q4W with MTX versus pegloticase 8 mg administered Q2W with MTX, on the response rate during Month 6, as measured by the sustained normalization of sUA to < 6 mg/dL for at least 80% of the time.

NCT ID: NCT06229132 Completed - Depression Clinical Trials

Mental Health Support for Transgender and Gender-expansive Individuals

Start date: March 15, 2022
Phase: N/A
Study type: Interventional

This study will evaluate an intervention's feasibility, acceptability and efficacy potential in a one-arm trial with Romanian transgender and gender diverse (e.g., gender non-binary) (TGD) individuals who report depression or anxiety. The intervention will consist of 16 1-hour sessions delivered by our trained therapists on Zoom. These sessions are based on 6 principles of LGBTQ-affirming CBT, as follows: (1) normalizing mood and anxiety as a common response to LGBTQ related stress; (2) challenging persistent, inflexible LGBQ-related stress-induced cognitions; (3) encouraging assertive behavior and open self-expression to effectively cope with the consequences of LGBTQ-related stress; (4) validating lesbian, gay, bisexual, and transgender (LGBTQ) clients' unique strengths; (5) building authentic relationships as an essential resource for LGBTQ people's mental health; and (6) recognizing intersectional identities as a source of stress and resilience.

NCT ID: NCT06229119 Not yet recruiting - Nearsightedness Clinical Trials

Vault Evaluation After ICL Implantation

Start date: January 29, 2024
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the lens vault after implantation of an implantable collamer lens (ICL). The ICL is designed to be implanted in front of the eye, without removing the natural lens. Because of this, it is also known as a phakic IOL. The ICL has already been approved by the U.S. Food and Drug Administration (FDA) to treat mid to high degrees of refractive errors such nearsightedness (also called myopia) with or without astigmatism. Once the artificial lens is implanted, a space between the ICL and the crystalline lens is created, which is called vault.

NCT ID: NCT06229106 Recruiting - Cataract Clinical Trials

Symfony vs Vivity in Dim Light

Start date: December 1, 2023
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the visual outcomes of the Symfony lens and the Vivity lens under mesopic lighting conditions in adult patients undergoing routine cataract surgery. Participants will be asked to read a visual acuity chart at different distances in dim light.