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NCT ID: NCT04690699 Active, not recruiting - Bladder Cancer Clinical Trials

LUMINOS-103: A Basket Trial Evaluating the Safety and Efficacy of Lerapolturev (PVSRIPO) and Lerapolturev in Combination With Anti-PD-1/L1 Checkpoint Inhibitors in Patients With Advanced Solid Tumors

Start date: August 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, open-label, multi-center, single arm basket study evaluating the administration of lerapolturev ± anti programmed cell death protein 1 (PD 1)/programmed death-ligand 1 (PD L1) monoclonal antibody (mAb) (which will be referred to throughout this protocol as "anti-PD-1/L1 therapy") therapy in adult patients with solid tumor cancers. Non-muscle invasive Bladder Cancer has been selected as the tumor specific cancer of interest for enrollment.

NCT ID: NCT04690582 Active, not recruiting - Ptsd Clinical Trials

Improving Treatment Outcomes for Suicidal Veterans With PTSD

Start date: January 15, 2021
Phase: N/A
Study type: Interventional

The efficacy of cognitive processing therapy (CPT) for reducing the symptoms of posttraumatic stress disorder (PTSD) across populations including military personnel and veterans is well supported. CPT also contributes to significant and rapid reductions in suicide ideation among people diagnosed with PTSD, although available evidence suggests this effect decays over time. Studies also show that approximately 1 in 6 people who begin CPT without suicide ideation will subsequently report suicidal thoughts at some point during or soon after completing treatment. Research focused on improving CPT's effects on suicide risk is therefore warranted. The primary aim of this study is to determine if the integration of a crisis response plan (CRP)--an empirically-supported procedure for reducing suicide ideation and attempts--can lead to faster reductions in suicide ideation among acutely suicidal veterans receiving CPT and prevent the development of suicide ideation among veterans who begin CPT without suicide ideation.

NCT ID: NCT04690205 Active, not recruiting - Clinical trials for Hematologic Malignancy

Hospital at Home at EOL in Heme Malignancies

Start date: February 26, 2021
Phase: N/A
Study type: Interventional

This study is evaluating an intervention, which the investigators call "Optimize End of Life (EOL) Care at Home," that entails remote patient monitoring and home-based supportive care for patients with advanced hematologic malignancies.

NCT ID: NCT04690010 Active, not recruiting - Kidney Calculi Clinical Trials

Ambulatory Versus Inpatient Percutaneous Nephrolithotomy

Start date: January 8, 2022
Phase: N/A
Study type: Interventional

The goal of the study is to determine if ambulatory tubeless PCNL is safe and effective compared to inpatient PCNL with a nephrostomy tube.

NCT ID: NCT04689997 Active, not recruiting - Substance Use Clinical Trials

Online System for Primary Care to Prevent and Address Teen Substance Use

Substance
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

This Quality Improvement (QI) project for physician education will build on an existing platform, CHADIS (Comprehensive Health and Decision Information System; www.CHADIS.com). We plan to further develop and test innovations that will assist primary care providers (PCPs) in addressing the serious morbidity of teen substance use during routine check-up visits and follow up care using a new Module of CHADIS that facilitates guideline-based care. The CHADIS c-SBI (computer-facilitated Substance screening and provider Brief Intervention) Module will include pre-visit screening tools that cover substance use and strengths and goals. It will also include reminders to the patient about their goals and commitments for change and a teleprompter for interview hints for the PCP. These hints will be aimed at enhancing a patient focused discussion of individual strengths and barriers related to the teens' goals in a motivational interviewing style.

NCT ID: NCT04689828 Active, not recruiting - Prostatic Neoplasms Clinical Trials

177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer

PSMAfore
Start date: June 15, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether 177Lu-PSMA-617 improves the rPFS or death compared to a change in ARDT in mCRPC participants that were previously treated with an alternate ARDT and not exposed to a taxane-containing regimen in the CRPC or mHSPC settings. Approximately 450 participants will be randomized (225 per treatment group).

NCT ID: NCT04688853 Active, not recruiting - Multiple Myeloma Clinical Trials

A Study to Investigate the Safety and Efficacy of TEG002 in Relapsed/Refractory Multiple Myeloma Patients

Start date: May 13, 2021
Phase: Phase 1
Study type: Interventional

This is a single arm, open-label, multicenter phase I study to assess the safety, tolerability and preliminary efficacy of autologous T cells transduced with a specific γδTCR, i.e. TEG002, in a dose escalation and expansion study in relapsed/refractory Multiple Myeloma patients. The study will comprise of a Dose Escalation Segment and an Expansion Segment. The study consists of a screening period, leukapheresis of mononuclear cells, and conditioning chemotherapy, followed by TEG002. All subjects continue to be followed regularly for safety and efficacy assessments until 1 year after TEG002 administration.

NCT ID: NCT04688476 Active, not recruiting - Clinical trials for HPV-associated Cancer

An Extended Follow-Up Study of the HPV Vaccine Delayed Booster Trial

Start date: November 17, 2020
Phase:
Study type: Observational

This is an extended follow-up study to follow-up study participants who received 1 booster dose of Gardasil 9 in the "HPV vaccine delayed booster trial." This was a prospective, single-arm, open-label, non-randomized, phase IIa trial among 9-11 year-old girls and boys to determine the immunogenicity after a single dose of the nonavalent HPV vaccine (Gardasil 9) over 24 months, with a delayed booster dose at 24 months and an optional booster at 30 months after the first dose. Participants provided blood specimens at 6, 12, 18, 24, and 30 months after the first dose. Serologic geometric mean titers (GMT) of the nine vaccine types (HPV 16/18/ 6/11/31/33/45/52/58) were measured at each time point. One hundred and thirty-three (133) participants received one booster dose at month 24 and elected not to receive the second booster at month 30. For this follow-up study, we anticipate that we will be able to accrue 120 participants from the original study who received just one booster dose. Participants who received one booster dose of Gardasil 9 will be contacted to return to the clinic to provide blood specimens at 48 (±3), 60 (±3), and 72 (±3) months after the priming dose. Serologic geometric mean titers (GMT) of the nine vaccine types (HPV 16/18/ 6/11/31/33/45/52/58) will be measured at each time point.

NCT ID: NCT04688450 Active, not recruiting - Clinical trials for Hypotension and Shock

BP Management System User Acceptance Testing

Start date: January 21, 2021
Phase: N/A
Study type: Interventional

This is a feasibility study for an investigational clinical decision support system ("the System") intended to optimize the management of blood pressure (BP) for patients during vasopressor infusion. The investigational outcomes are the perceptions of the nurse-subjects who are managing the BP of the patient-subjects; the operational performance of the System; and any technical failures of the software during real-time operation.

NCT ID: NCT04687917 Active, not recruiting - Substance Use Clinical Trials

The Substance Abuse Treatment to HIV Care II (SAT2HIV-II) Project

SAT2HIV-II
Start date: January 14, 2021
Phase: N/A
Study type: Interventional

An experiment to test the effectiveness of providing monetary bonuses to staff for achieving pre-defined performance targets regarding the implementation of a motivational interviewing-based brief intervention for substance use.