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Discover 17,885 clinical trials near Houston, Texas. Find research studies in your area.
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NCT03988855
This is an open-label study to evaluate the safety, efficacy, and PK of DNV3837 at a dose of 1.5 mg/kg actual body weight(BW)/day administered via IV infusion in subjects with CDI. The study will be conducted in 2 subsequent parts. In Part 1 of the study, 10 subjects of either sex with severe or non-severe CDI will be enrolled to receive DNV3837. In Part 2 of the study, up to 30 subjects with severe or non-severe CDI will be enrolled to receive DNV3837. In both parts of the study, treatment infusions will be administered at a constant rate resulting in a total IV infusion duration of 6 hours per day, for a total maximum daily dose of 120 mg DNV3837. Infusions will be administered once daily for 10 consecutive days. The objectives of the study are: * To evaluate the safety of intravenous (IV) DNV3837; * To evaluate the efficacy of IV DNV3837; * To assess the pharmacokinetics (PK) of DNV3837 and DNV3681 in plasma and of DNV3681 in urine and feces; * To assess C. difficile using microbiological assessments; * To assess the proportion of subjects colonized with vancomycin-resistant enterococci (VRE), extended-spectrum beta-lactamase (ESBL) organisms, or carbapenem-resistant Enterobacteriaceae (CRE) in feces; and * To assess changes in the fecal microbiome using 16S ribosomal ribonucleic acid (RNA) analysis
NCT03229174
This is a double blind placebo controlled trial in Parkinson's disease (PD) patients with neurogenic orthostatic hypotension (NOH). Investigators hypothesize that the study drug (droxidopa) may improve cerebral perfusion more robustly than systemic BP, possibly by direct action within the CNS vasculature. This study is designed to determine if droxidopa improves cerebral perfusion measures in PD patients with NOH, in addition to peripheral BP measures and subjective responses.
NCT03638258
This is a parallel group, double blind, vehicle-controlled study in which roflumilast (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.
NCT03764475
This is an open-label, long-term safety study of roflumilast (ARQ-151) 0.3% cream in subjects with chronic plaque psoriasis involving up to 25% total Body Surface Area (BSA). Study medication will be applied by the qualifying subjects topically once daily for 52 weeks at home. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression.
NCT04302142
The purpose of the study is to achieve effective ventilation with critical intracuff pressure (Pcr) and determine if application of Pcr reduces the risks associated with over-insufflation of endotracheal cuff including postoperative sore throat, cough,nausea, vomiting, aspiration, and pneumonia.
NCT00508794
In this study researchers will examine the initial efficacy of implementing a yoga program for patients with breast cancer as an adjuvant to their radiotherapy. Patients with breast cancer who are undergoing radiotherapy will be randomly assigned to either a yoga group (YG), or a stretching (ST) control group, or a waitlist control (WL) group. Participants in YG and ST groups will attend three sessions each week throughout their 6-week radiotherapy schedule. The sessions will be coordinated with the treatment schedule and conducted adjacent to the treatment facility. Measures will be obtained prior to randomization, a brief assessment during the middle of radiation therapy, during the last week of radiation therapy, and 1, 3 and 6 months after the last radiation session. With the inclusion of two control groups in this randomized trial researchers will attempt to validate the benefits of yoga as an adjuvant to radiotherapy in patients with breast cancer wherein researchers will control for specific components of the yoga program and also examine some of the mechanisms that are necessary for the program to be effective. Our specific aims in the proposed study are to: * Conduct an initial evaluation of whether participation in the yoga program improves patients' fatigue and sleep disturbances. Fatigue and sleep will be assessed with self-report measures and the use of actigraphy for a more objective measure of sleep quality. * Secondary end points will include examining QOL, mental health and objective physiological outcomes (blood samples for immune measures, saliva samples for cortisol levels, and heart rate variability). * Exploratory analyses will examine some plausible mediators of the yoga program including cognitive processing, spirituality, and finding meaning in the cancer experience.
NCT04363736
This study will assess the pharmacodynamics, pharmacokinetics, safety and efficacy of two different doses of tocilizumab (TCZ) in combination with standard-of-care (SOC) in hospitalized adult participants with moderate to severe COVID-19 pneumonia.
NCT04483349
To assess the importance patients place on each of the attributes of value (i.e., outcomes, quality of life \[QOL\], cost, experience), and how these patients’ views differ depending on the stage of their therapy (pretreatment, preoperative therapy, post-operative, long-term surveillance, recurrence).
NCT02891226
The purpose of this study is to evaluate the safety and effectiveness of the study drug Mirikizumab in participants with active Crohn's Disease.
NCT03977168
The objective of this study is to evaluate the effect of earlier placement of Circumferential Pelvic Compression (CPC) on resuscitative measures required for life-threatening pelvic ring injuries and to guide the development of future efficacy trials of three advanced resuscitation techniques (surgical pelvic packing, angioembolization, REBOA).
NCT04093622
The purpose of the study is to assess long-term side effects from subjects who receive a Fate Therapeutics genetically modified NK cell product. Subjects who previously took part in a Fate Therapeutics study and received genetically changed NK cells will take part in this long-term follow-up study. Subjects will join this study once they complete the parent interventional study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study. For a period of 15 years starting from the last administration of Fate Therapeutics genetically modified NK cell product, subjects will be assessed for long-term safety and survival through questionnaires and blood tests.
NCT01328093
The purpose of this study is to determine whether weight gain will be significantly less in LY2140023 than aripiprazole in patients with schizophrenia.
NCT03889886
SDP-4-CS201, is a Phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the ocular and systemic safety and efficacy of SDP-4 ophthalmic solution in subjects with moderate to severe dry eye disease over a 12-week treatment period. Three concentrations (0.1%, 1.0% and 3.0%) of SDP-4 ophthalmic solution will be given to parallel groups via topical ocular instillation BID.
NCT03634982
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of escalating doses of RMC-4630 monotherapy in adult participants with relapsed/refractory solid tumors and to identify the recommended Phase 2 dose (RP2D).
NCT03823703
This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis (NASH).
NCT04154462
Background and study aims: Medical scribes are trained paraprofessionals that assist providers with documenting patient encounters. Prior evidence suggests that scribes may be effective in increasing provider productivity and satisfaction, and decreasing provider time spent on documentation without negatively affecting patient satisfaction. Section 507 of the MISSION Act of 2018 mandated a two-year pilot of medical scribes, which will begin in March 2020 in specialty clinics and emergency departments (EDs) of twelve VA Medical Centers (VAMCs) across the country. The aims of this study are to understand how the introduction of scribes and scribe training affect provider efficiency, patient and provider satisfaction, wait times, and daily patient volume in the VA context. Who can participate? Urban and rural VAMCs willing to be assigned medical scribes for use in EDs or selected high wait time specialty clinics (cardiology, orthopedics). What does the study involve? Four medical scribes will be assigned to each of the 12 VAMC sites randomized into treatment with the VA hiring half as new employees and contracting out for the remaining half. 30% of the scribes will be assigned to emergency departments and the other 70% will be assigned to specialty care. Remaining sites that expressed interest in the pilot but were not randomized treatment will be used as comparators. Provider productivity, patient volume, wait times, and patient satisfaction from the treated sites will be compared to baseline (pre-scribe) data as well as data from comparison sites. What are the possible benefits and risks of participating? VAMCs where medical scribes are introduced may see gains in provider efficiency, reduced wait times, and increased patient satisfaction due to the shifting of administrative burdens associated with documenting patient encounters in electronic health records from providers to these trained professionals. The introduction of medical scribes could complicate patient encounters by making some patients and/or providers uncomfortable. Where is the study run from? This study is being coordinated by the Partnered Evidence-based Policy Resource Center (PEPReC) at the VA Boston Healthcare System in collaboration with the VA Office of Veterans Access to Care (OVAC). When is the study starting and how long is it expected to run for? March 2020 to February 2022 Who is funding the study? U.S. Veterans Health Administration
NCT04831944
The purpose of the study is to evaluate the pharmacokinetics and safety of parsaclisib in participants With normal hepatic function and participants with hepatic impairment.
NCT03736928
An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA treatment for glabellar lines
NCT00715143
The purpose of this study is to collect and evaluate long-term safety and effectiveness data on the Exactech® NOVATION ™ Ceramic Articulation Hip System ("NOVATION ™ Ceramic AHS").
NCT03837743
This Phase 2 study has been designed to determine and compare the safety, tolerability, and efficacy of DUR-928 topical solution with that of the vehicle topical solution when applied once daily for approximately four weeks in subjects with plaque psoriasis. Subjects will be instructed (randomly assigned) to apply DUR-928 solution to a target lesion on one arm and vehicle solution to a target lesion on the opposite arm once daily for up to four weeks. Subjects will occlude the treated areas for approximately two hours after each application.
