UT Health San Antonio

This will be a randomized, controlled pilot trial of patients with histological documentation of primary colon or rectal adenocarcinoma with resectable cancer, who have not received any treatments for cancer. If patient is a candidate for surgical resection, with no planned neoadjuvant chemotherapy, then the patient is eligible. All eligible subjects will be consented prior to surgery.

Type: Interventional

Start Date: Jan 2017

open study

This randomized clinical trial studies how well an adaptive computerized cognitive training program works compared to a non-adaptive computerized cognitive training program in treating younger patients with brain tumor who underwent radiation therapy. Providing a computer training program may improve the well-being and quality of life of patients with cognitive (physical and mental) function difficulties caused by radiation therapy to the brain.

Type: Interventional

Start Date: Nov 2013

open study

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid ?Master Protocol? (S1400). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes a ?non-match? sub-study which will include all screened patients not eligible for any of the biomarker-driven sub-studies. This sub-study will compare a non-match therapy to standard of care also with the goal of approval.

Type: Interventional

Start Date: Jun 2014

open study

HYPOTHESIS: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have distinct pathophysiologic etiologies. Therefore, therapeutic interventions designed to correct the specific underlying pathogenic abnormalities in IGT and IFG will be required to optimally prevent the progressive beta cell failure and development of overt type 2 diabetes.

Type: Interventional

Start Date: Jan 2014

open study

Title: Optimal Delay Time to Initiate Anticoagulation after Ischemic Stroke in Atrial Fibrillation (START): a pragmatic, adaptive randomized clinical trial. Primary Objective: • To determine the optimal time to initiate anticoagulation with a Non-Vitamin K Oral Anticoagulant (NOAC) after ischemic stroke in patients with non-valvular atrial fibrillation. Secondary Objectives: - To compare the rates of primary adverse outcomes in a per protocol analysis - To compare 30 day clinical outcomes by the modified Rankin scale among the time-to-treatment groups - To compare 30 day clinical outcomes by the PROMIS-10 scale among the time-to-treatment groups. - To compare 90 day clinical outcomes by the modified Rankin scale among the time-to-treatment groups - To explore the optimal timing in subgroups of age, sex, outcome category, and NOAC choice

Type: Interventional

Start Date: Jun 2017

open study

Type 2 diabetes is a systemic metabolic disease with significant morbidity and mortality due to damaging blood vessels. Increased blood sugar level is a hallmark of diabetes and is an contributes to the development of many of its complications. Multiple defects, e.g. impaired insulin secretion and impaired insulin action, contribute to the development of the disease. The aim of this study is to test the efficacy and durability of combination of drugs which correct the defects that lead to the development of diabetes on achieving adequate and durable control of blood sugar levels. Achieving adequate and durable control of blood sugar will prevent many of diabetes complications.

Type: Interventional

Start Date: Jan 2009

open study

This randomized phase III trial studies bortezomib, lenalidomide, and dexamethasone to see how well they work compared to carfilzomib, lenalidomide, and dexamethasone in treating patients with newly diagnosed multiple myeloma. Bortezomib and carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may help the immune system kill abnormal blood cells or cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether bortezomib, lenalidomide, and dexamethasone are more or less effective than carfilzomib, lenalidomide, and dexamethasone in treating patients with multiple myeloma

Type: Interventional

Start Date: Dec 2013

open study

This randomized phase IIb trial studies how well low-dose carvedilol works in preventing heart failure in cancer survivors exposed to high dose anthracyclines for management of childhood cancer. Patients who received high-dose anthracycline chemotherapy are at a much greater risk for developing heart failure compared to survivors who didn?t get any anthracycline chemotherapy. Heart failure happens when the heart muscle has been weakened and can?t pump blood as well as it should. Carvedilol may help lower the risk of cardiovascular complications.

Type: Interventional

Start Date: Apr 2016

open study

The purpose of this first-in-human (FIH) study of BLZ945 given as a single agent or in combination with PDR001 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and anti-tumor activity of BLZ945, administered orally, as a single agent or in combination with PDR001, administered intravenously (i.v.) in adult patients with advanced solid tumors. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. Once MTD/ RP2D is declared, patients will be enrolled in the phase II part in the selected indications (glioblastoma, pancreatic cancer and triple negative breast cancer) to further assess the preliminary anti-tumor activity of BLZ945 in combination with PDR001. Should signs of anti-tumor activity be seen in the phase I dose escalation with BLZ945 as single agent, a phase II part will be opened in order to further explore BLZ945 single agent efficacy at the recommended dose.

Type: Interventional

Start Date: Oct 2016

open study

This phase 2 clinical study will be a randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, tolerability, biological activity, and pharmacokinetics (PK) of ND-L02-s0201 for Injection in subjects with IPF.

Type: Interventional

Start Date: Jun 2018

open study

Purpose/Objectives: Examining the effect of SGLT2 inhibition on EGP and plasma glucose concentration in diabetic subjects after kidney transplantation (i.e. renal denervation) or in subjects after renal sympathectomy (63) can add insight about the possible role of a neural arc which mediates the changes in plasma glucagon and/or insulin concentration in response to glucosuria.

Type: Interventional

Start Date: Oct 2016

open study

Premature rupture of membranes refers to the rupture of the fetal membranes prior to the onset of labor. Premature rupture of membranes is associated with a number of neonatal and maternal complications including an increased incidence of perinatal mortality and intra-amniotic infection. There is a need for improved diagnostic testing because of limitations of the current methods. PRO-MComplete is an immunochromatographic test that detects insulin growth factor binding protein 1 and alpha-fetoprotein in vaginal fluid as an indicator of membrane rupture.

Type: Observational

Start Date: Aug 2015

open study

The primary objective of the study is to determine the maximally tolerated dose and recommended Phase 2 dose of CBL0137 when administered intravenously (IV) to patients with metastatic or unresectable advanced solid malignancies.

Type: Interventional

Start Date: Jul 2013

open study

To determine in a randomized trial whether it is possible to decrease the discomfort and anxiety of mammography by using the local analgesic lidocaine, or by using calming music in patients receiving a mammogram.

Type: Interventional

Start Date: Oct 2016

open study

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Type: Observational

Start Date: Oct 2015

open study

This clinical trial keeps track of and collects follow-up information from patients who are currently enrolled on or have participated in a Children's Oncology Group study. Developing a way to keep track of patients who have participated in Children's Oncology Group studies may allow doctors learn more about the long-term effects of cancer treatment and help them reduce problems related to treatment and improve patient quality of life.

Type: Observational

Start Date: May 2008

open study

Current guidelines for the clinical management of acute spinal cord injury (SCI) recommend maintenance of mean arterial blood pressure (MAP) at 85 to 90 mmHg for the first seven days after SCI as a clinical option. Unfortunately, the medical evidence to support this recommendation exists only at the clinical case series level (Class III data). Furthermore, maintenance of sustained systemic hypertension, as per clinical guidelines, may be associated with risks to the patient via adverse medical events. Given this equivocal evidence, the investigators group has questioned the merit of sustained induced hypertension following acute SCI and has previously conducted a randomized, prospective controlled feasibility study to further examine this issue. This prior pilot study randomized patients with acute SCI to a spinal cord perfusion pressure (SCPP = MAP - intrathecal pressure (ITP)) target of ≥ 75 mmHg or to a control group (hypotension avoidance, MAP ≥ 65 mmHg). The primary endpoint measure was defined as the change in American Spinal Injury Association (ASIA) motor score from baseline. No difference in the primary outcome was noted at one-year post-SCI in this study. In light of this pilot data, the investigators hypothesize that maintenance of normotension (MAP ≥ 65mmHg) is not inferior to induced hypertension (MAP ≥ 85mmHg) for 7 days following acute SCI. As such, the investigators propose to conduct a Phase III non-inferiority prospective, randomized clinical trial in acute SCI patients. Subjects will be randomized into one of two MAP management groups for 7 days; Group 1 will be managed with a target MAP ≥ 65 mmHg, while Group 2 will be managed with a target MAP ≥ 85 mmHg. The primary endpoint will be change in ASIA motor score from baseline at 12 months post injury. A difference of ≤10 ASIA motor points change from baseline between groups will be considered as non-inferiority. Secondary endpoints will include ASIA sensory score, proportion of patients achieving a one grade improvement in ASIA impairment scale, quality of life assessment (as measured by Short-Form-36 [SF-36]) and functional outcome (as measured by the Spinal Cord Independence Measure (SCIM) and Functional Independence Measure (FIM). These will be measured at baseline, 72 hours and 3, 6 and 12 months from injury. Adverse events will be meticulously recorded. The information gleaned from this trial will provide valuable information for the acute treatment of traumatic SCI and will serve the objective of optimizing current clinical practice and thus maximizing medical and neurological outcome for individuals following acute traumatic SCI.

Type: Interventional

Start Date: Feb 2013

open study

A randomized, blinded, controlled trial to evaluate growth velocity and clinical outcomes in infants with single ventricle physiology fed an exclusive human milk diet prior to, and throughout the post-operative period following, surgical repair. Human milk is defined as expressed human milk or donor milk and its derivatives, human milk-based fortifier and human milk caloric fortifier. The study hypothesis is that infants fed an exclusive human milk diet will have short and long term benefits, with improved wound healing, growth, and neurodevelopmental outcomes while reducing episodes of feeding intolerance and necrotizing enterocolitis (NEC).

Type: Interventional

Start Date: Jul 2016

open study

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer

Type: Interventional

Start Date: Aug 2013

open study

This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

Type: Interventional

Start Date: Jul 2015

open study

This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

Type: Observational

Start Date: Nov 2000

open study

This research trial studies kidney tumors in younger patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Type: Observational

Start Date: Feb 2006

open study