Clinical trials: sponsored by The Methodist Hospital Research Institute
ALS (Amyotrophic Lateral Sclerosis)
T-regulatory Cells in ALS
This study is a randomized, placebo-controlled, phase 2a trial to study the biological activity, safety, and tolerability of regulatory T Lymphocytes (Tregs) taken and expanded outside of the body and returned back to the same…
- Trial name
- Tregs in ALS (NCT04055623)
- Testing
- Monthly autologous Treg cells infusions + 3 times per week Interleukin-2 injections
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- The Methodist Hospital Research Institute
ALS (Amyotrophic Lateral Sclerosis)
Ph1 T-Regulatory Cells in Amyotrophic Lateral Sclerosis
Open-label pilot study to determine the safety and tolerability of autologous CD4+ CD25+ regulatory T cells infusions with concomitant subcutaneous IL-2 injections taken 3 times per week in 3 participants with ALS.
- Trial name
- NCT03241784
- Testing
- Autologous T-regulatory lymphocytes, Interleukin-2
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- The Methodist Hospital Research Institute
Virtual Reality
Usability, Acceptability, and Safety of Virtual Reality-based Cognitive Intervention
This study aims to determine feasibility, acceptability, and usability, and to assess the safety of using a virtual reality-based software called ''ReCognitionVR'' in healthy volunteers.
- Trial name
- NCT05583903
- Testing
- Virtual Reality Software
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- The Methodist Hospital Research Institute
Chemotherapy-induced Peripheral Neuropathy
Trial to Study Electro-Acupuncture in Subjects With Chemotherapy-Induced Peripheral Neuropathy
This study will determine the feasibility and efficacy of a 10-treatment electro-acupuncture (EA) program in subjects with chemotherapy-induced peripheral neuropathy (CIPN).
- Trial name
- NCT07455409
- Testing
- Electro-acupuncture
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- The Methodist Hospital Research Institute
Breast Cancer
Durvalumab With Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer
The purpose of this research study is to test the safety and effectiveness of using durvalumab with trastuzumab and pertuzumab in participants with human epidermal growth factor receptor 2 (HER2)-enriched breast cancer.
- Trial name
- DTP (NCT03820141)
- Testing
- Durvalumab, Trastuzumab, Pertuzumab
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- The Methodist Hospital Research Institute
Non-Small Cell Lung Cancer, Malignant Melanoma
Phase Ib of L-NMMA and Pembrolizumab
The purpose of this Phase Ib study is to test the safety of NG-monomethyl-L-arginine (L-NMMA) and pembrolizumab when used together in participants with melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell…
- Conditions
- Non-Small Cell Lung Cancer, Malignant Melanoma, Head and Neck Squamous Cell Carcinoma, Classical Hodgkin Lymphoma
- Trial name
- NCT03236935
- Testing
- L-NMMA, Pembrolizumab
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- The Methodist Hospital Research Institute
Triple Negative Breast Cancer, Anthracycline-refractory TNBC
Docetaxel Chemotherapy and Pembrolizumab Plus Interleukin-12 Gene Therapy in Triple Negative Breast Cancer
The purpose of this research study is to test the safety and effectiveness of docetaxel chemotherapy and pembrolizumab plus adenoviral-mediated interleukin-12 (ADV/IL-12) gene therapy in patients with anthracycline-refractory…
- Trial name
- INTEGRAL (NCT04095689)
- Testing
- Docetaxel, Pembrolizumab, IL-12 gene therapy
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- The Methodist Hospital Research Institute
Shoulder Injuries
IO Vancomycin in TSA
The purpose of this study is to compare two different antibiotic regimens and techniques during total shoulder arthroplasty. Primary Objective: Comparable levels of vancomycin will be found in bone, soft tissue, and systemic…
- Trial name
- NCT05831774
- Testing
- Intervention - Intraosseous (IO) administration of vancomycin, Control - Standard IV administration of vancomycin
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- The Methodist Hospital Research Institute
Surgery, Delirium
Feasibility and Acceptability of ReCognitionVR-based Cognitive Stimulation in Surgical Patients
This study aims to assess the feasibility, acceptability, and safety of using ReCognitionVR virtual reality-based software in older surgical patients.
- Conditions
- Surgery, Delirium, Delirium, Post-Operative
- Trial name
- NCT06232317
- Testing
- Virtual Reality Software, Traditional Orientation Methods
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- The Methodist Hospital Research Institute
Ventricular Tachycardia, Atrial Fibrillation
Vein of Marshall Ethanol Infusion for Persistent Atrial Fibrillation
The broad, long-term objective of this project is to evaluate the therapeutic value of vein of Marshall (VOM) ethanol infusion when added to catheter ablation of atrial fibrillation (AF).
- Trial name
- VOM-R01 (NCT01898221)
- Testing
- Ethanol, Ablation
- Where
- 12 sites in United States
- Volunteers
- 343 people
- Sponsor
- The Methodist Hospital Research Institute
Multiple Sclerosis, Lower Urinary Tract Symptoms
Central Nervous System Changes Following OnabotulinumtoxinA Injection in the Bladder
The purpose of this research study is to evaluate higher neural changes following intra-detrusor injection of Onabotulinumtoxin-A (BTX-A) in patients with Multiple Sclerosis (MS).
- Conditions
- Multiple Sclerosis, Lower Urinary Tract Symptoms, Neurogenic Bladder, Detrusor, Overactive
- Trial name
- NCT03033355
- Testing
- Intra-detrusor injection of Onabotulinumtoxin-A
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- The Methodist Hospital Research Institute
Pelvic Floor Disorders, Stress Urinary Incontinence
Educating Women About Pelvic Floor Disorders During Pregnancy
The purpose of this study is to assess the increase in knowledge of pregnant patients regarding pelvic floor disorders when comparing two educational interventions: written handouts vs interactive workshops.
- Conditions
- Pelvic Floor Disorders, Stress Urinary Incontinence, Pelvic Organ Prolapse
- Trial name
- NCT05440539
- Testing
- Written Handouts, Interactive Workshop
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- The Methodist Hospital Research Institute
Neurogenic Bladder, Lower Urinary Tract Symptoms
Optimization of OnabotulinumtoxinA (BTX-A) Injection for the Treatment of Neurogenic Lower Urinary Tract Dysfunction
The purpose of this study is to evaluate and standardize the way providers perform OnabotulinumtoxinA (BTX-A) injections into the bladder for the diagnosis of neurogenic lower urinary tract dysfunction (NLUTD)/overactive bladder…
- Conditions
- Neurogenic Bladder, Lower Urinary Tract Symptoms, Overactive Bladder, Neuro: Neurogenic Bladder
- Trial name
- BOND (NCT06059066)
- Testing
- Standard number of injection sites, Reduced number of injection sites
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- The Methodist Hospital Research Institute
Overactive Bladder
Procedural Discomfort Related to Number of Intradetrusor Botox Injections
Injection of intradetrusor OnabotulinumtoxinA (BTX-A) is a highly efficacious therapy with a reliable safety profile and demonstrable improvements in subjective and objective measures for overactive bladder (OAB) symptom control.
- Trial name
- BIND (NCT05652036)
- Testing
- Intradetrusor Botox Injections
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- The Methodist Hospital Research Institute
Prosthetic Joint Infection, Vancomycin
Intraosseous Vancomycin in Primary Total Hip Arthroplasty - Designing a Protocol
The objective of this study is to evaluate a novel vancomycin intraosseous administration protocol vs a standard IV vancomycin administration protocol for primary total hip arthroplasty patients.
- Conditions
- Prosthetic Joint Infection, Vancomycin, Joint Diseases
- Trial name
- NCT04042233
- Testing
- Experimental Intraosseous vancomycin 500mg in 250 mL NS, Standard IV administration of vancomycin
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- The Methodist Hospital Research Institute
ACL Tear
Effects of Blood Flow Restriction Rehabilitation After Anterior Cruciate Ligament Reconstruction
The study is a prospective randomized control trial consisting of subjects requiring ACL reconstruction with BTB autograft. Subjects were randomly divided into two groups following their inclusion in the study.
- Trial name
- NCT04484961
- Testing
- Blood flow restriction (BFR)
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- The Methodist Hospital Research Institute
Metastatic Non-small Cell Lung Cancer, Metastatic Triple-negative Breast Cancer
SBRT and Oncolytic Virus Therapy Before Pembrolizumab for Metastatic TNBC and NSCLC
This is a Phase II trial to determine the efficacy and safety of stereotactic body radiation therapy (SBRT) and in situ oncolytic virus therapy used as a window of opportunity treatment before pembrolizumab in patients with…
- Trial name
- STOMP (NCT03004183)
- Testing
- ADV/HSV-tk, Valacyclovir, SBRT
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- The Methodist Hospital Research Institute
Knee Disease, Arthritis Knee
Intraosseous Morphine in Primary TKA
The research team wants to investigate if an intraosseous injection (directly into the bone marrow) of morphine during primary total knee replacement helps with post-operative pain following primary total knee replacement…
- Conditions
- Knee Disease, Arthritis Knee, Pain, Acute
- Trial name
- NCT04388111
- Testing
- Morphine
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- The Methodist Hospital Research Institute
Healthy
Blood Flow Restriction Training for The Shoulder
The aim of this study is to determine if BFR-LIX promotes greater increases in shoulder lean mass, rotator cuff strength, endurance, and acute increases in shoulder muscle activation compared to LIX alone.
- Trial name
- NCT04540367
- Testing
- Blood flow restriction therapy
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- The Methodist Hospital Research Institute
Metastatic Triple Negative Breast Cancer
L-NMMA Plus Taxane Chemotherapy in Refractory Locally Advanced or Metastatic Triple Negative Breast Cancer Patients
This is a Phase Ib/II study assessing the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), recommended Phase 2 dose (RP2D), and efficacy of L-NMMA when combined with docetaxel in refractory locally advanced or…
- Trial name
- NCT02834403
- Testing
- L-NMMA, Docetaxel, Amlodipine
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- The Methodist Hospital Research Institute