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Discover 17,885 clinical trials near Houston, Texas. Find research studies in your area.
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NCT06975436
In the clinical performance part of this study, prospectively acquired clinician-collected and clinician-instructed, self-collected vaginal swab specimens collected in cobas® PCR Media will be taken from a minimum of 500 symptomatic individuals with a clinical presentation consistent with vaginitis, vaginosis, or both. Additionally, a minimum of 100 asymptomatic individuals will also be enrolled in the study. The cobas® BV/CV assay amplifies and detects the deoxyribonucleic acid (DNA) of pathogens associated with bacterial vaginosis (BV) and candida vaginitis (CV). The BV results will be compared with the patient infection status (PIS) established by using 3 Food and Drug Administration (FDA)-cleared commercial assays, and the CV results will be compared with the PIS established with the use of culture plus MALDI-TOF (matrix-assisted laser desorption/ionization time-of-flight). The primary objective of the clinical performance study is to evaluate the performance (sensitivity and specificity) of cobas® BV/CV to determine the presence of BV and/or CV in the intended use patient population when being tested on cobas® 6800/8800 systems. The secondary objective is to evaluate the equivalency of cobas® BV/CV between the cobas® 5800 system and cobas® 6800/8800 systems.
NCT03725059
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer. The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.
NCT04789408
The goal of this clinical study is to learn more about the safety and dosing of the study drug, KITE-222, in participants with relapsed/refractory (r/r) acute myeloid leukemia (AML).
NCT07060014
This study will evaluate the safety and efficacy of NALIRIFOX per NAPOLI-3 regimen as first-line chemotherapy for patients with advanced small intestine and appendiceal cancers. Female or male patients aged 18 years, or older, with histopathologically or cytologically confirmed advanced mucinous or non-mucinous appendix cancer or advanced small intestine cancer will be eligible for participation in the study.
NCT06073093
This is a parallel group, Phase 2, randomized, double-blind, placebo controlled, 5-arm, international, multicenter, 12-week proof of concept, dose finding study. It is designed to assess efficacy and safety of treatment with SAR441566 for 12 weeks. It will be conducted in male and female adult participants with moderate-to-severe rheumatoid arthritis (RA) not adequately controlled on methotrexate (MTX) and biologic/targeted synthetic disease modifying anti-rheumatic drug (DMARD) naive. Study treatment includes investigational medicinal product (IMP: SAR441566 or placebo) added-on to a background therapy of MTX. Study details include a run-in period (4 to 6 weeks) before randomization to determine eligibility, a treatment period (12 weeks ± 3 days) and a post-treatment period (safety follow-up) (2 weeks ± 3 days). The total number of scheduled study visits will be 8.
NCT05328297
The purpose of this study is to evaluate the efficacy of JNJ-55308942 compared to placebo on symptoms of depression in participants with bipolar disorder (BD) in a major depressive episode (MDE) at Week 6.
NCT00710892
Patients are being asked to participate in this study because they will be receiving a stem cell transplant as treatment for their disease. As part of the stem cell transplant, they will be given very strong doses of chemotherapy, which will kill off all their existing stem cells. Stem cells are created in the bone marrow. They grow into different types of blood cells that we need, including red blood cells, white blood cells, and platelets. We have identified a close relative of the patients whose stem cells are not a perfect match for the patient, but can be used. This type of transplant is called "allogeneic", meaning that the cells come from a donor. With this type of donor who is not a perfect match, there is typically an increased risk of developing graft-versus-host disease (GvHD) and a longer delay in the recovery of the immune system. GvHD is a serious and sometimes fatal side effect of stem cell transplant. GvHD occurs when the new donor cells recognize that the body tissues of the patient are different from those of the donor. In the laboratory, we have seen that cells made to carry a gene called iCasp9 can be killed when they encounter a specific drug called AP1903. To get the iCasp9 into the T cells, we insert it using a virus called a retrovirus that has been made for this study. The drug (AP1903) that will be used to "activate" the iCasp9 is an experimental drug that has been tested in a study in normal donors, with no bad side effects. We hope we can use this drug to kill the T cells. Other drugs that kill or damage T cells have helped GvHD in many studies. However we do not yet know whether AP1903 will kill T cells in humans, even though it has worked in our experimental studies on human cells in animals. Nor do we know whether killing the T cells will help the GvHD. Because of this uncertainty, patients who develop significant GvHD will also receive standard therapy for this complication, in addition to the experimental drug. We hope that having this safety switch in the T cells will let us give higher doses of T cells that will make the immune system recover faster. These specially treated "suicide gene" T cells are an investigational product not approved by the Food and Drug Administration.
NCT06487806
The purpose of this study is to test the usability, engagement and acceptability of SmokefreeSGM Español, a culturally and linguistically tailored version of SmokefreeSGM, among Spanish-speaking SGM smokers.
NCT06140303
The purpose of this study is to assess the safety and efficacy of SkinTE for treatment of Wagner grade 1 diabetic foot ulcers.
NCT05147233
This was a randomized, double-masked, vehicle-controlled, Phase 3 study evaluating the efficacy and safety of OCS-01 QD compared to vehicle in the treatment of inflammation and pain following cataract surgery.
NCT04177394
This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.
NCT02230072
The purpose of the study is to evaluate the maternal and fetal outcomes of a new technique for the fetoscopic repair of fetal MMC at Texas Children's Hospital Pavilion for Women. The investigators hypothesis is that this minimally invasive technique is feasible, and that this approach will have the same efficacy as open fetal surgery for MMC, but with significantly less maternal-fetal risk. Both mother and baby will benefit from the surgery. The fetus will have a repaired MMC defect, and the mother will not have a uterine incision (hysterotomy). A hysterotomy increases the risk of uterine rupture and requires that all subsequent deliveries are by cesarean section. There may also be a decreased risk of Pre-term Premature Rupture Of Membranes (PPROM) and prematurity when compared with the current open operation. Finally, a vaginal delivery is possible following the fetoscopic fetal surgery if the baby is shown to have a skin covered repair.
NCT05827978
This study includes 3 parts: Parts A, B, and C. The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1010 seasonal influenza vaccine in adults.
NCT06648655
TMP-301 has been shown in preclinical models to reduce consumption of alcohol and other addictive substances. It has been tested in healthy subjects and has been found to be safe and tolerated at doses predicted to be efficacious in alcohol use disorder. This study is being conducted to evaluate the safety, tolerability and efficacy of TMP-301 in patients with alcohol use disorder.
NCT06397131
This study is to determine the long-term levels of CNTF, and the clinical safety and efficacy of the NT-501 implants with the Medica Hollow Fiber Membrane (MHFM) in participants with macular telangiectasia type 2.
NCT05563272
A prospective, open-label, phase 2 study to explore CAIX expression through 89Zirconium-labelled girentuximab deferoxamine (89Zr-girentuximab) PET/CT imaging in patients with solid tumors.
NCT06212466
A prospective, multicenter, observational, single-arm trial to validate CardioFlux MCG's ability to diagnose myocardial ischemia caused by coronary microvascular dysfunction in patients with suspected ischemia and confirmed no obstructive coronary artery disease (suspected INOCA) by using diagnostic measures of coronary flow reserve (CFR) via invasive angiography as a reference standard for diagnosis.
NCT06843577
The study will be a multi-center, randomized clinical trial to evaluate the safety and efficacy of using the Zona Plus handgrip therapy device compared to the use of an auditory relaxation therapy for treatment of high blood pressure and hypertension in subjects who are not currently taking antihypertensive medications. Half of the study subjects will also be randomized to record blood pressure at home throughout the study.
NCT05200715
Autoinflammatory diseases (AID) are clinical entities characterized by recurrent inflammatory attacks in absence of infection, neoplasm or deregulation of the adaptive immune system. Among them, hereditary periodic syndromes, also known as monogenic AID, represent the prototype of this disease group, caused by mutations in genes involved in the regulation of innate immunity, inflammation and cell death. Based on recent experimental acquisitions in the field of monogenic AID, several immunologic disorders have been reclassified as polygenic/multifactorial AID, sharing pathogenetic and clinical features with hereditary periodic fevers. This has paved the way to new treatment targets for patients suffering from rare diseases of unknown origin, including Behçet's disease, Still disease, Schnitzler's disease, PFAPA (periodic fever, aphthous stomatitis, pharyngitis and cervical adenitis) syndrome, chronic recurrent multifocal osteomyelitis (CRMO), non-infectious uveitis and scleritis. Gathering information on such rare conditions is made difficult by the small number of patients, along with the difficulty of obtaining an accurate diagnosis in non-specialized clinical settings. In this context, the AIDA project promotes international collaboration among clinical centres to develop a permanent registry aimed at collecting demographic, genetic, clinical and therapeutic data of patients affected by monogenic and polygenic AID, in order to expand the current knowledge of these rare conditions.
NCT03992417
Primary Objective: To characterize the patients who receive Dupixent® (dupilumab) for AD in a real-world setting, with respect to their medical history, socio-demographic and disease characteristics, and prior and concomitant treatments of AD Secondary Objectives: * To characterize real-world use patterns of Dupixent® for AD (eg, used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching) * To assess the long-term effectiveness of Dupixent® in AD patients in a real-world setting * To assess comorbid atopic conditions and effects of treatment in comorbid atopic conditions in patients who receive Dupixent® for AD * To collect safety data on study participants
