Search Results
Action Regulation Behavioral
Nader Pouratian, MD, Phd nader.pouratian@utsouthwestern.edu
Sahil Chilukuri, BS sahil.chilukuri@utsouthwestern.edu
Cerebral Autoregulation, Brain Perfusion, and Neurocognitive Outcomes After Traumatic Brain Injury (CAPCOG-TBI)
Kan Ding, MD kan.ding@utsouthwestern.edu
Jill Morales, BA jill.morales@utsouthwestern.edu
Accelerated rTMS for Substance Use Disorder and Depression
This study is a small open-label feasibility trial of an accelerated course of repetitive transcranial magnetic stimulation (rTMS) for individuals with depression and stimulant use disorder [including methamphetamine or cocaine use disorder (MUD/CUD)].
studyfinder@utsouthwestern.edu
• Be aged 18-65 years, inclusive.
• Be able to sufficiently understand, speak, and read English to provide informed consent and ask relevant questions, and be willing to comply with all study procedure instructions.
• Self-report stimulant use (cocaine, methamphetamine, or prescription stimulants) at least 10 days in the 30-day period prior to consent.
• Have a diagnosis of moderate or severe Cocaine or Methamphetamine Use Disorder (CUD/MUD) or other Stimulant Use Disorder over the past 12 months (as determined by the MINI International Neuropsychiatric Interview).
• Have a PHQ9 of greater than or equal to five (5).
• Be willing to provide urine samples, EEGs, and ECGs.
• Be willing to use appropriate birth control method during the treatment phase of the study, if individual is of childbearing potential.
• Have a current pattern of alcohol, benzodiazepine, or other sedative/hypnotic use that would preclude safe participation in the study, as determined by the PI or their designee.
• Have a history of a serious medical disorder that, in the opinion of the PI or their designee, would make it unsafe to participate in the study or may prevent collection of study data (e.g., disabling terminal diagnosis for which hospice care is being sought; serious illness requiring systemic treatment and/or hospitalization until participant either completes therapy and/or is clinically stable on therapy, in the opinion of the PI or their designee, prior to study entry).
• Have a documented history of unprovoked seizure (lifetime) or any seizure in the past 6 months.
• Have a documented history of brain lesion(s) and/or tumor(s).
• Have metal implants or non-removable metal objects above the neck.
• Current pregnancy as determined by a urine screening.
• Current or lifetime manic or hypomanic episode, defined by MINI diagnostic interview.
• Current psychotic disorder.
• Are a prisoner or in police custody at the time of eligibility screening.
A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy (ACES-EMB)
This is an open label Comparative Effectiveness Research (CER) study in which patients will be randomized at the site level to Prospera surveillance or EMB surveillance in a 2:1 ratio (Prospera to EMB) at each site. Subjects will be enrolled into the study while under evaluation for heart transplantation or on the transplant waiting list prior to heart transplantation. All subjects will follow the center's standard of care surveillance schedule from transplant through 4 weeks post-transplantation. EMB during this phase is expected to occur roughly weekly or bi-weekly. Study group assignment will take place at randomization. Subjects will be randomized 30 days (± 10 days) post-transplant to Prospera surveillance versus EMB surveillance in a 2:1 ratio. Rejection surveillance (Prospera Group and EMB Group) will be performed at times corresponding to the institutional standard of care schedule for rejection surveillance.
Amy Browning Amy.Browning@utsouthwestern.edu
• Age 18 years or older at the time of signing informed consent.
• Undergoing transplant evaluation or currently on the heart transplant waiting list and expected to receive a heart transplant.
• Able to read, understand and provide written informed consent. If the patient is unable to sign informed consent, a legally authorized representative (LAR) can consent on behalf of the patient.
• Able and willing to comply with the study visit schedule, study procedures and study requirements.
• Concurrent multiple solid organ or tissue transplants.
• Prior history of any organ or cellular transplantation.
• Planned use of other commercially available or investigational cfDNA or gene expression profile assays for rejection surveillance.
• Pregnant.
• Hemodynamically unstable or other serious medical condition that may adversely affect the subject's ability to participate in the study.
Phase III Study of AK112 for NSCLC Patients
studyfinder@utsouthwestern.edu
• Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.
• Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent. (For patients from North America and Europe, there will be no upper age cutoff)
• ECOG performance status score of 0 or 1.
• Expected survival ≥3 months.
• Histologically or cytology-confirmed, locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC (according to TNM staging of lung cancer, 8th edition) that cannot be completely resected by surgery and cannot receive radical concurrent/sequential chemoradiation.
• EGFR activation mutations that are confirmed by tumor histology or cytology or blood test before enrollment (eg, exon 18 point mutations, exon 19 deletions, exon 20 point mutations, and exon 21 point mutations). Patients must provide a previous EGFR mutation test report, otherwise tumor tissue samples, peripheral blood samples, or pleural fluid samples will need to be collected for EGFR status testing prior to enrollment.
• Prior treatment with EGFR TKI and treatment failure, meeting any of the following requirements: Progression after treatment with first- or second-generation EGFR TKI, and confirmation of absence of T790M mutation after progression (only for patients enrolled in China). Progression after treatment with a third-generation EGFR TKI (eg, osimertinib, ametinib, vometinib). Note, for North America and Europe patients only.
• According to RECIST v1.1, there is at least 1 measurable noncerebral lesion.
• Adequate organ function determined by the following requirements
• Female patients of childbearing age have a negative serum pregnancy test result within 3 days before the first dose
• If a female patient of childbearing potential has sex with an unsterilized male partner, the patient must use a highly effective method of contraception from the beginning of screening and must agree to continue using these precautions until 120 days after the last dose of the study drug or until 6 months after the last carboplatin and pemetrexed dose (whichever is longer).
• If an unsterilized male patient has sex with a female partner of childbearing potential, the patient must use an effective method of contraception from the beginning of screening to day 120 after the last dose or until 6 months after the last carboplatin and pemetrexed dose (whichever is longer). The decision to stop contraception after this time point should be discussed with investigator.
• Histologic or cytopathologic evidence of the presence of a small cell carcinoma component, or a predominantly squamous cell carcinoma.
• Patients who have received immune checkpoint inhibitors (eg, anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-LAG-3 antibodies, etc.)
• Received prior systemic chemotherapy, anti-angiogenic therapy, or more than one prior line of antitumor therapy (other than EGFR inhibitors) for advanced stage (IIIB to IV) NSCLC.
• Concurrent enrollment in another clinical study, unless it is a noninterventional clinical study or the follow-up period of the interventional study is more than 4 weeks from the last dose of the prior clinical study or more than 5 half-lives of the prior study drug, whichever is shorter.
• Received EGFR inhibitor therapy within 2 weeks (with the exception of osimertinib to be within 7 days) prior to the first dose; received nonspecific immunomodulatory therapy (eg, interleukin, interferon, thymus peptide, tumor necrosis factor) within 2 weeks prior to the first dose, excluding IL-11 for the treatment of thrombocytopenia; have received Chinese herbal medicines or proprietary Chinese medicines with antitumor indications within 1 week before the first dose.
• Imaging during the screening period shows that the tumor surrounds important blood vessels or has obvious necrosis and/or cavitation of tumor lesions within the lung parenchyma.
• Imaging during the screening period shows that the tumor invades the surrounding vital organs and blood vessels, such as the heart and pericardium, trachea, esophagus, aorta, superior vena cava, or patient is at risk of esophageal tracheal fistula or esophageal pleural fistula.
• Symptomatic metastases of the central nervous system.
• Malignant tumors other than NSCLC within 3 years before the first dose.
• Active autoimmune disease requiring systemic therapy (eg, with disease-modifying drugs, corticosteroids, immunosuppressant therapy) within 2 years prior to the first dose (excluding ir AEs due to PD-1/L1 inhibitors). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent) for adrenal or pituitary insufficiency) is permitted.
• There is a history of major diseases before the first dose
• History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection, complicated by chronic diarrhea) within 6 months before the first study drug administration.
• Patients with \>30 Gy of chest radiation therapy within 6 months prior to the first dose, nonthoracic radiation therapy \>30 Gy within 4 weeks prior to the first dose, and palliative radiation therapy of ≤30 Gy within 2 weeks prior to the first dose and failed to recover from the toxicity and/or complications of these interventions to NCI CTCAE Grade ≤1 (except hair loss and fatigue). Palliative radiotherapy for symptom control is permitted if it has been completed at least 2 weeks before the first dose, and no additional radiotherapy for the same lesion is planned.
• Inactivated vaccines are allowed. Patients are excluded if they have received a live vaccine or live attenuated vaccine within 4 weeks prior to the first dose, or if they are scheduled to receive a live vaccine or live attenuated vaccine during the study period.
• Severe infection within 4 weeks prior to the first dose, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection that has received systemic anti-infective therapy within 2 weeks prior to the first dose (excluding antiviral therapy for hepatitis B or C)
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Renal Function in Adults Living With Obesity (TRIUMPH-OUTCOMES)
The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the worsening of kidney function. The trial will enroll adults with body mass index 27 kg/m^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease. The study will last for about 5 years. Participants will have up to 27 clinic visits with the study doctor.
studyfinder@utsouthwestern.edu
Study of the Clinical and Radiological Impact of Ravulizumab in People With Neuromyelitis Optica Spectrum Disorder (AMAZE)
Cindy Daniel cindy.daniel@utsouthwestern.edu
Francisco Villalobos francisco.villalobos@utsouthwestern.edu
• Signed informed consent available prior to conduct of any study associated activities
• Men and women \> 18 years of age
• Aquaporin-4 IgG positive people with neuromyelitis optica spectrum disorder treated with commercially available ravulizumab in a manner consistent with the approved indication
• Expanded Disability Status Scale score of \<7.0
• Individuals who are intolerant to MRI
• Individuals previously exposed to eculizumab with treatment discontinuation due to lack of effective disease control (i.e., clinical relapse or demonstration of MRI advancement after 12 weeks of sustained treatment exposure)
• Unresolved meningococcal disease
• History of an active infection
• Existing participation in neuromyelitis optical spectrum disorder interventional clinical studies
• Pregnant or lactating women
Screening for AL Amyloidosis in Smoldering Multiple Myeloma
In this multicenter study, we will recruit 400 patients 40 years of age or older at 15 centers with a diagnosis of smoldering multiple myeloma (SMM), a group of patients for whom standard of care is observation not treatment. The main goal of this study is to screen for the diagnosis of light-chain amyloidosis (AL) before the onset of symptomatic disease and to develop a training set for a likelihood algorithm.
studyfinder@utsouthwestern.edu
A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight
This study will look at how a new medicine called NNC0519-0130 helps people with excess body weight lose weight. The study will test up to 6 different doses of NNC0519-0130. Participants will take 1-2 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 42 weeks.
studyfinder@utsouthwestern.edu
Health Outcomes of Parents With Cystic Fibrosis-Aim 2 (HOPeCF)
Ashley Keller ashley.keller@utsouthwestern.edu
A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)
The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin).
studyfinder@utsouthwestern.edu
Identifying Strategies to Curtail Weight Regain After GLP-1 Receptor Agonist Treatment Cessation
Longitudinal studies show there is a steep increase in weight regain in the first 3-4 months after stopping GLP-1 receptor agonist medications (GLP-1s) and most patients regain most of their weight within a year. Insurers now question the utility of GLP-1s for weight loss as they are hesitant to cover these costs long-term (~$833 per person per month). Some patients would also prefer not to take these medications in perpetuity and are likely to struggle with lifelong adherence. These challenges present an opportunity to test alternative interventions, such as meal replacements and behavioral treatments, to support weight maintenance after successful weight loss with GLP-1s. This regimen would allow patients to benefit from significant weight loss in the first year of taking GLP-1s and use more cost effective and sustainable strategies for long-term maintenance.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Carolyn.Haskins@UTSouthwestern.edu
• 18 years of age or older;
• ability to read, write, and speak English;
• ability to provide informed consent;
• greater than 10% GLP-1 Receptor Agonist induced weight loss
• less than 30-days since GLP-1 Receptor Agonist cessation;
• willing to participate. Exclusion criteria:
• major psychiatric illness or substance misuse that could impair ability to participate;
• presence of a medical condition or dietary restriction precluding eating study meals or weight loss (e.g., medical condition requiring liquid diet, pregnancy, eating disorder);
• participation in a study or program involving medically tailored meals or Noom® within the past 12-months.
Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-WLS
The goal of this cross-sectional observational study is to examine potential relationships between the blood and gut microbiota of patients with obesity before and after weight loss surgery (WLS) and evaluate potential ethnic differences in the blood and gut microbiotas before and after the WLS. The main aims / objectives of this sub-study are: - Aim 1. Compare the relationship between the blood and the gut microbiomes among a sample of (1) pre-WLS and (2) 6-month post-WLS participants. Hypothesis: Blood bacterial composition will resemble that of the gut microbiome among pre-WLS participants. Because the effect of WLS on the blood microbiome is not known, our post-WLS results will be mostly exploratory. - Aim 2. Determine racial differences in the blood microbiome of the pre- and post-WLS groups. Hypothesis2: Ethnic differences will be detected in both the pre- and post-WLS groups.
studyfinder@utsouthwestern.edu
Phenotyping of Postural Orthostatic Tachycardia Syndrome (POTS)
This is an observational study to deeply phenotype the disorder of POTS using multiple testing modalities.
Steve Hopkins steve.hopkins@utsouthwestern.edu
A Study of Tiragolumab Plus Atezolizumab Compared With Placebo Plus Atezolizumab in Participants With Completely Resected Non-small Cell Lung Cancer Who Have Received Adjuvant Platinum-based Chemotherapy (SKYSCRAPER-15)
studyfinder@utsouthwestern.edu
Deep Brain Stimulation for Psychosis
There are three hypotheses proposed for this study: 1) Participants will report no unanticipated serious adverse events during the eight months of treatment. 2) Investigators will successfully model psychotic versus non-psychotic brain states using support vector machine (SVM) classifiers. 3) Participants specific brain stimulation parameters can induce a change in the brain state consistent with non-psychotic states as measured by classifier output. Hypotheses 1, 2, and 3 address safety and tolerability, efficacy, and the putative mechanism of successful treatment. The overall objective is to use next generation Deep Brain Stimulation (DBS) combined with antecedent stereo electroencephalogram (SEEG) mapping to establish a new therapy for treatment-refractory schizophrenia given the limitations of current treatment modalities. The primary objective is to demonstrate safety of acute and chronic network guided stimulation for treatment-refractory schizophrenia. Exploratory Objectives: 1. Use intracranial mapping (SEEG) combined with pharmacological manipulation of psychotic states to create a protocol for participant specific deep brain stimulation to treat treatment-refractory schizophrenia. 2. Develop closed loop stimulation protocols to modify brain states during psychotic brain activity induced by low-dose ketamine administration. 3. Investigate the use of mnemonic similarity to characterize brain networks related to symptoms of treatment-refractory schizophrenia. 4. Treatment-related objectives: Record a reduction in psychotic symptoms, as well as an improvement in psychosocial function and cognition.
studyfinder@utsouthwestern.edu
• Men and women (non-pregnant) between ages 22 and 70;
• Diagnostic and Statistical Manual of Mental Disorders (DSM) -5 diagnosis (assessed by Structured Clinical Interview for DSM-5 Axis I disorders SCID-5) of schizophrenia as the primary diagnosis.
• Medically healthy, without any acute serious medical disorders
• Treatment refractory and previous trials of treatment defined as: Demonstrated non-sustained response to at least two different antipsychotic drugs from two different chemical families. And demonstrated non-sustained response to at least either an electroconvulsive therapy (ECT) or a clozapine trial.
• Suffering from active and ongoing psychotic symptoms of a continuous and aversive nature.
• The PANSS must remain greater than or equal to 90 on two separate assessments (at initial screening and 1 week before surgery), over a 1-month period;
• At least one item on the PANSS positive subscale is 5 or greater.
• Normal brain MRI within 3 months of surgery;
• Stable antipsychotic medication regimen for the month preceding surgery;
• Normal thyroid stimulating hormone (TSH) level within 12 months of study entry;
• Other medical conditions must be stable for at least 6 months;
• Able and willing to give informed consent and agree to attend regular clinic visits for at least 12 months following surgery;
• Able to have a treating psychiatrist or close relative present for discussions about the study and co-sign informed consent;
• Willingness to sign Treatment Contract.
• Participants with a family or caregiver support system to aid the participant throughout the study will be preferentially selected for inclusion.
• For women of childbearing potential:
• Required to provide a negative pregnancy blood test during screening phase of the study, and during several additional timepoints throughout study participation.
• Obligated to use highly effective (those that when used alone or in combination, result in a low failure rate \[i.e., less than 1 percent per year\], when used consistently and correctly) methods of birth control throughout study participation.
• Will be allowed to participate in the study only after a confirmed menstrual period.
• For men: Obligated to use highly effective (those that when used alone or in combination, result in a low failure rate \[i.e., less than 1 percent per year\], when used consistently and correctly) methods of birth control throughout study participation.
• Active alcohol or substance use disorder within 6 months, excluding nicotine; Urine drug test positive for illicit drugs;
• Current substantial suicidal risk as defined by a plan or clear immediate intent for self-harm, or made a suicide attempt within the last year; or as identified as The Columbia Suicide Severity Rating Scale (C-SSRS),
• Neurological/Medical condition that makes the participant, in the opinion of the surgeon, a poor surgical candidate (e.g., progressive neurodegenerative disorder, significant cardiopulmonary disorder, need for chronic anticoagulation);
• Any history of seizure disorder, hemorrhagic stroke, or has high risk of seizure (history of congenital brain malformation, history of brain injury, neuro-developmental disorder, currently taking medication that is known to lower seizure threshold, or other factors that predispose seizures);
• Any medical contraindication to surgery such as infection;
• Coagulopathy: Bleeding propensity and/or one of the following: international normalised ratio (INR) \> 1.5; prolonged activated partial thromboplastin time (aPTT) ≥ 45 sec; platelet count \< 100×103 /uL;
• Uncontrolled hypertension (systolic \> 140mmHg and/or diastolic \> 90 mmHg), demonstrated on each of three repeated measurements taken within one hour regardless of whether or not the participant is taking antihypertensive medications.
• Patients with a heart-rate corrected QT interval (QTc) of \> 450 msec
• Participation in another drug, device, or biological study within 90 days;
• Current implanted stimulation devices including cardiac pacemakers, defibrillators, and neurostimulators including spinal cord stimulators and deep brain stimulators;
• Need for Diathermy;
• Chronic use of anticoagulant or anti-platelet agents that cannot be safely stopped for a sufficient duration (minimum 2.5 weeks) in the peri-operative period.
• Any Psychiatric/Neurological/Medical condition that makes the participant, in the opinion of the Investigator, a poor candidate.
• A female participant of childbearing potential who is not able or willing to use highly effective (those that when used alone or in combination, result in a low failure rate \[i.e., less than 1 percent per year\], when used consistently and correctly) methods of birth control throughout the duration of participation in the trial.
• A female participant of childbearing potential who is not able or willing to provide a negative pregnancy blood test during the screening phase of the study and during several additional timepoints throughout study participation. Specifically, the investigators will require a pregnancy test on the day of ketamine (or placebo) administration to avoid the risk of administering ketamine to a pregnant patient.
• A separate cardiac condition that, in the opinion of study physician would present an unacceptable risk of undergoing general anesthesia or ketamine administration.
• Participants with poorly controlled hypertension or persistent tachycardia, at baseline, will be excluded.
• Participants who are taking an anti-depressant medication.
• Any known contraindications for ketamine and/or esketamine (Spravato):
• Patients for whom a significant elevation of blood pressure would constitute a serious hazard, according to the opinion of the study PI.
• Patients with known hypersensitivity to ketamine, esketamine, or to any of the excipients.
• Patients with Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial, and peripheral arterial vessels) or arteriovenous malformation.
• Patients with a history of intracerebral hemorrhage.
• Patients with resting heart rate over 90 or below 55 beats per minute (BPM)
• Participants taking a medication with a known interaction with ketamine or esketamine (amphetamines, monoamine oxidase (MAO)-Is, aminophylline, theophylline, norepinephrine, epinephrine, vasopressin, dobutamine, ephedrine, ethanol, Ergometrine/Ergonovine). Patients taking benzodiazepines will not be excluded as this is recommended to prompt monitoring of patients in the information for esketamine. Dr. McDonagh will review such cases including for symptoms of sedation associated with their use and the dosage and duration of therapy for each. The investigators will exclude subjects who have any evidence of central nervous system (CNS) depression, such as decreased level of arousal or respiratory depression, thought to be linked with CNS depressants. The investigators will use the PRODIGY score to exclude any patient taking one of these medicines determined to be HIGH risk (score of 15 points or higher, https://www.apsf.org/wp-content/uploads/newsletters/online-only/202006/PRODIGY-Interactive-Risk-Assessment-Tool.pdf). The investigators note that ketamine has been used as an adjunct for sedation with benzodiazepines and opiates in the anesthesia environment, and the FDA's guidance on ketamine states: "KETALAR has been studied in over 12,000 operative and diagnostic procedures, involving over 10,000 patients from 105 separate studies. During the course of these studies KETALAR was administered as the sole agent, as induction for other general agents, or to supplement low-potency agents."
• During the ketamine administration phase in the hospital, patients with a history of benzodiazepine (or other CNS depressant) usage will undergo more frequent documentation of respiratory rate and heart rate (every 10 minutes). All patients will undergo continuous pulse oximetry monitoring to initiate supportive measures if there is any evidence of respiratory depression. In any patient with a history of opiate or 3-quinuclidinyl benzilate (BZ) administration, the investigators will have both flumazenil and naloxone immediately available at the bedside for administration if there is any evidence of respiratory distress.
• On the day of planned ketamine (or placebo) administration, Dr. McDonagh will review all medicines being administered to the patient to ensure there is no potential interaction. This will be documented on the Ketamine Administration Checklist included in appendix 6.
• On the day of planned ketamine (or placebo) administration, subjects will undergo a urine drug screen to avoid the accidental administration of ketamine to a patient who tests positive for any agents that is contraindicated (such as psychostimulants or CNS depressants). This is now reflected in the ketamine administration checklist (appendix 6).
A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors
The purpose of this study is to find out whether the study drug, LY4101174, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2)
The purpose of the study is to evaluate how effective JNJ-77242113 is in participants with moderate to severe plaque psoriasis compared to placebo and deucravacitinib.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Aleuna.Lee@UTSouthwestern.edu
Trial of Naltrexone/Bupropion for the Treatment of Methamphetamine Use Disorder
studyfinder@utsouthwestern.edu
• Is 18 to 65 years of age;
• Meets DSM-5 criteria for moderate or severe MUD (4 or more criteria);
• Is interested in reducing or stopping MA use;
• Is able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study;
• Self-reports MA use on 18 or more days in the 30-day period prior to consent using the Timeline Followback (TLFB);
• Provides at least 2 urine samples positive for MA out of up to 3 tests, which will occur at least 2 days apart within a 10-day period;
• If assigned as female at birth and/or currently has a uterus, is not pregnant, agrees to use acceptable birth control methods, and have periodic urine pregnancy testing done during participation in the study unless documentation of hysterectomy provided;
• Is not physically dependent on opioids and meets subjective and objective measures of being opioid-free prior to naltrexone injection per study medical clinician's determination, including, if clinically required, a negative naloxone challenge;
• Is willing to comply with all study procedures and medication instructions;
• Agrees to use a smartphone app (downloaded for free to own device or on a study provided smartphone device) to take daily videos of medication dosing.
• Has an acute medical or psychiatric disorder that would, in the judgment of the study medical clinician, make participation difficult or unsafe;
• Has suicidal or homicidal ideation that requires immediate attention;
• Has a history of epilepsy, seizure disorder, or head trauma with neurological sequelae (e.g., loss of consciousness that required hospitalization); current anorexia nervosa or bulimia; or any other conditions that increase seizure risk in the opinion of the study medical clinician;
• Has evidence of second or third degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc, or any other finding on the screening ECG that, in the opinion of the study medical clinician, would preclude safe participation in the study;
• Has Stage 2 hypertension as determined by the study medical clinician (e.g., greater than or equal to 160/100 in 2 out of 3 readings during screening);
• Has any elevated bilirubin test value per laboratory criteria OR any other liver function test (LFT) value \> 5 times the upper limit of normal per laboratory criteria;
• Has a platelet count \<100 x 10exp3/microliter;
• Has a body habitus that precludes gluteal intramuscular injection of XR-NTX in accordance with the administration equipment (needle) and procedures;
• Has a known allergy or sensitivity to bupropion, naloxone, naltrexone, PLG (polyactideco-glycolide), carboxymethylcellulose or any other component of the XR-NTX diluents;
• Has been in a prior study of pharmacological or behavioral treatment for MUD within 6 months of study consent;
• Has taken an investigational drug in another study within 30 days of study consent;
• Has been prescribed and taken naltrexone or bupropion within 30 days of study consent;
• Is concurrently enrolled in formal behavioral or pharmacological Substance Use Disorder (SUD) treatment services;
• Is receiving ongoing treatment with tricyclic antidepressants, xanthines (i.e., theophylline and aminophylline), systemic corticosteroids, nelfinavir, efavirenz, chlorpromazine, MAOIs, central nervous system stimulants (e.g., Adderall, Ritalin, etc.), or any medication that, in the judgment of the study medical clinician, could interact adversely with study medications;
• Has a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study as determined by the study medical clinician;
• Requires treatment with opioid-containing medications (e.g., opioid analgesics) during the study period;
• Has a surgery planned or scheduled during the study period;
• Is currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) that could prevent participation in the study or in any study activities;
• If assigned as female at birth and/or currently has a uterus, is currently pregnant, breastfeeding, or planning on conception.
A Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid
Purpose: To decrease symptom burden, improve cognitive function, improve endurance, and decrease fatigue in subjects with post-acute sequelae of COVID-19 (PASC) or "long-hauler" COVID using amantadine. If amantadine use is determined to be efficacious in this population, the findings of this study will be used towards a subsequent randomized control trial.
Brittany Wright, PhD brittany.wright@utsouthwestern.edu
A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation (ATHENA)
The study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (inactive substance that looks like the study medicine but does not contain any medicine). The treatment participants get is decided by chance. Participant's chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study is expected to last for up to 1 year and 4 months.
studyfinder@utsouthwestern.edu
• Left atrial (LA) volume index greater than 34 milliliter per square meter (mL/m\^2)
• LA diameter greater than or equal to 3.8 centimeter (cm)
• LA length greater than or equal to 5.0 cm
• LA area greater than or equal to 20 square centimeter (cm\^2)
• LA volume greater than or equal to 55 milliliter (mL)
• Intraventricular septal thickness greater than or equal to 1.1 cm
• Posterior wall thickness greater than or equal to 1.1 cm
• LV mass index greater than or equal to 115 gram per square meter (g/m\^2) in men or greater than or equal to 95 g/m\^2 in women h) E/e' (mean septal and lateral) greater than or equal to 10 i) e' (mean septal and lateral) less than 9 centimeter per second (cm/s) * No heart failure hospitalisations or urgent heart failure visits between screening and randomisation * Able to perform the 6-minute walk test (6MWT) at screening with a minimum distance of 100 metres * Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score lesser than 80 at screening
A Dose-finding Study to Evaluate mRNA-3210 in Participants With Phenylketonuria
The main goal of this study is to assess the safety, and tolerability of multiple doses of mRNA-3210 in participants with phenylketonuria (PKU).
Call 214-648-5005
studyfinder@utsouthwestern.edu, Juana.Luevano@UTSouthwestern.edu
• Confirmed diagnosis of PKU due to phenylalanine hydroxylase (PAH) deficiency by molecular genetic testing from a central lab.
• At least 3 blood phenylalanine levels ≥600 micromole(μmol)/Litre (L) regardless of diet: 2 obtained during the screening period (at least 72 hours apart) and at least one historical value 6 to 24 months prior to start of screening.
• Have received documented approval from a study dietitian confirming that participant is willing and able to maintain dietary protein intake consistent with baseline intake during study participation.
• If applicable, maintained stable dose of neuropsychiatric medication (that is, for attention deficit hyperactivity disorder (ADHD), depression, anxiety, or other psychiatric disorders) prior to enrollment and willing to maintain stable dose throughout study participation unless, per investigator assessment, a change is clinically indicated.
• Receipt of sapropterin or large-neutral amino acids within 14 days or 5 half-lives (whichever is longer) of the start of screening.
• Receipt of pegvaliase within 2 months of start of screening.
• For participants previously on pegvaliase: use or planned use of any injectable drugs containing polyethylene glycol (PEG), including medroxyprogesterone injection, within 3 months prior to the start of screening and during study participation with the exception of COVID-19 vaccinations.
• Receipt of any investigational drug within 30 days or 5-half-lives (whichever is longer) of screening.
• History of hypersensitivity to any component/excipient used in this study.
• Any other clinically significant medical condition that, in the Investigator's opinion, could interfere with the interpretation of study results or limit the participant's participation in the study Note: Other protocol-defined inclusion/exclusion criteria apply.
Polypill for Prevention of Cardiomyopathy (PolyPreventHF)
This study will investigate the utility of a polypill-based strategy for patients with type 2 diabetes mellitus and high risk of heart failure (HF), as assessed via the WATCH-DM risk score. Polypill therapy will consist of empagliflozin 12.5 mg, losartan 50 or 100 mg, and finerenone 10 mg daily. The study duration is 3 months, and participants will be randomized to either polypill therapy or usual care. The primary outcome is change in peak VO2 and adherence to usual care. The investigators hypothesize that the use of a polypill is feasible and improves medication adherence and peak VO2 as compared to those receiving usual care.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Neil.Keshvani@UTSouthwestern.edu
• Patients with Type 2 DM and urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 30 to less than 300 and an estimated glomerular filtration rate (eGFR) of 25 to 90 ml per minute per 1.73 m2 of body-surface area (stage 2 to 4 CKD) with either a:
• High risk of HF as defined by High Watch-DM score (≥11) or
• Elevated natriuretic peptides or
• Diastolic dysfunction or left ventricular hypertrophy on echocardiography
• eGFR < 25
• Congestive heart failure
• Hyperkalemia > 5.0
• Contraindication to any component of polypill
• Pregnancy
• Creatinine >2.0mg/dL in men and >1.8mg/dL in women
• Inability to calculate WATCH-DM score
• Inability to undergo exercise testing
Efficacy of LoDoCo in Improving Exercise Capacity Among Patients With HFpEF and Inflammation
The purpose of this research study is to determine the effectiveness of low dose colchicine (LoDoCo) on measures of exercise capacity, physical function, frailty, and quality of life, among patients with heart failure with chronic stable preserved ejection fraction (HFpEF) and systemic inflammation. The use of LoDoCo in this study is considered investigational as it has not been approved by the Food and Drug Administration (FDA) for the treatment of exercise capacity in patients with HFpEF. Participants will undergo a 1-day screening that includes a blood draw and physical examination. If deemed eligible for the study, participants will undergo a baseline visit within 2 weeks of screening visit that includes physical examination, exercise testing, echocardiography and completion of quality-of-life surveys. Participants will also be randomized at this visit (randomly assigned to a group) to receive either LoDoCo or placebo (inactive substance) for 3 months. Participants will be called back at 3 months for repeat physical examination, blood draws, echocardiography, exercise testing and completion of quality-of-life surveys. Each visit will take about 3 hours. Total study duration is about 3 months.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Lajjaben.Patel@UTSouthwestern.edu
• 1. Informed consent was obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
• Age 50 years or above at the time of signing the informed consent. 3. Serum hs-CRP 2 mg/L at the time of baseline testing. 4. Diagnosis of chronic HFpEF within 6 months of enrolment must have one of the following: a. Structural Heart Disease with one of the following on echocardiography within 12 months of enrolment. i. LA volume index > 34 ml/m2. ii. LA diameter ≥ 3.8 cm. iii. LA length ≥ 5.0 cm. iv. LA area ≥ 20 cm2. v. LA volume ≥ 55 mL. vi. Intraventricular septal thickness ≥1.1 cm. vii. Posterior wall thickness ≥1.1 cm. viii. LV mass index ≥115 g∕m2 in men or ≥ 95 g∕m2 in women. ix. E/e' (mean septal and lateral) ≥ 10. x. e' (mean septal and lateral) < 9 cm/s b. Pulmonary capillary wedge pressure (PCWP) at rest³15 mmHg or Left ventricular end-diastolic pressure (LVEDP) ³18 mmHg, (PCWP) with exercise ³25 mmHg or (³ 2 mmHg/L/min) c. HF hospitalization or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous loop diuretic treatment, within the last 9 months prior to enrolment in combination with NT-proBNP ≥ 125 pg/mL within 1 month of enrolment for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening NT-proBNP must be ≥ 300 pg/mL 5. Ambulatory participants who can perform cardiopulmonary exercise testing. 6. Stable doses of HF-specific medications within the last 1 month.
• Stable level of physical activity 8. Stable dose of any weight loss medications.
• 1. Do not otherwise meet the inclusion criteria. 2. Women who are pregnant, breastfeeding, or may be considering pregnancy during the study period.
• Renal impairment: eGFR <30mL/min 4. Severe valvular heart disease is considered likely to require intervention. 5. Life expectancy <1 year. 6. Unable to perform cardiopulmonary exercise testing. 7. ALT or AST >2.5 ULN at time of screening
A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight
This study will look at how well CagriSema compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Participant will get injections once a week throughout the treatment period. Participant will inject the study medicine under the skin with a pen injector in the thigh, stomach, or upper arm. After a first low dose, the study medicine will be gradually increased until reaching the planned dose (2.4 mg CagriSema or 15 mg Tirzepatide). The study will last for about one and a half year for each participant.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Chioma.Elendu@UTSouthwestern.edu
Study to Evaluate Safety, Tolerability and Drug Levels of BMS-986435/MYK-224 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) (AURORA-HFpEF)
The purpose of this study is to evaluate the safety, tolerability, and exposure-response (E-R) of BMS-986435/MYK-224 in participants with symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF).
studyfinder@utsouthwestern.edu
• Adult participants with stable, symptomatic HFpEF with a normal heart pumping ability. Exclusion Criteria * Participants must not have a known diagnosis of obstructive or genetic hypertrophic cardiomyopathy or infiltrative/storage disorder such as cardiac amyloidosis, or any other acute or serious condition that could interfere with assessments during the study or may pose a risk to the participant. * Other protocol-defined Inclusion/Exclusion criteria apply.
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer (ALISCA-Lung1)
PUMA-ALI-4201 is a Phase 2 study evaluating alisertib monotherapy in patients with pathologically-confirmed small cell lung cancer (SCLC) following progression on or after treatment with one platinum-based chemotherapy and anti-PD-L1 immunotherapy agent. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy. This study is intended to identify the biomarker-defined subgroup(s) that may benefit most from alisertib treatment and to evaluate the efficacy, safety, and pharmacokinetics of alisertib.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
• Aged ≥18 years at signing of informed consent
• Pathologically confirmed SCLC
• Prior treatment with one platinum-based chemotherapy and an anti-PD-L1 immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy
• Prior treatment with an AURKA specific-targeted or pan-Aurora-targeted agent, including alisertib in any setting Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Randomized, Double-blind Study of Efficacy and Safety of Bexotegrast (PLN-74809) for Idiopathic Pulmonary Fibrosis
studyfinder@utsouthwestern.edu
• ≥ 40 years of age prior to screening
• IPF diagnosis ≤ 7 years prior to screening
• FVCpp ≥ 45%
• Diffusing capacity for carbon monoxide percent predicted (hemoglobin-adjusted) ≥ 30% and \< 90%
• Current treatment for IPF with background therapy is allowed, if at a stable dose for ≥ 12 weeks prior to screening
• If not currently receiving treatment for IPF (either treatment naïve or discontinued prior treatment), participant must not have taken background therapy for at least 8 weeks prior to screening
• Receiving pharmacologic therapy for pulmonary hypertension
• Self-reported smoking of any kind (not limited to tobacco)
• History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, resected noninvasive cutaneous squamous cell carcinoma, or treated cervical carcinoma in situ
• Hepatic impairment or end-stage liver disease
• Renal impairment or end-stage kidney disease requiring dialysis
• Pregnant or lactating female participant
• Uncontrolled systemic arterial hypertension
• Receiving any unapproved or investigational agent intended for treatment of fibrosis in IPF
• Prior administration of bexotegrast
• Likely to have lung transplantation during the study (being on transplantation list is not an exclusion)
• Forced expiratory volume in the first second (FEV1)/FVC ratio \<0.7 at screening
• Clinical evidence of active infection, including, but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening or at randomization
• Known acute IPF exacerbation, or suspicion by the Investigator of such, 6 months prior to screening
Phase II Randomized Study of Hypofractionated Versus Conventional Radiotherapy (G-FORCE)
To compare the acute tolerance of highly conformal hypofractionated versus conventional radiotherapy.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
• Pathologically-proven diagnosis of squamous cell carcinoma in situ, squamous cell carcinoma, or squamous cell variants (sarcomatoid, verrucous, basaloid, and papillary subtypes) involving the glottic larynx.
• Clinical stage 0-II (AJCC, 8th edition) with direct laryngoscopy showing no evidence of greater than stage II true glottic larynx cancer and PET/CT or CT neck showing no evidence of regional disease.
• Minimum age is 18 years.
• ECOG Performance Status 0-2
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• 1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
• Ability to understand and the willingness to sign a written informed consent.
• AJCC stage III or stage IV larynx cancer
• Involvement of the arytenoid cartilage beyond the vocal process.
• Prior chemotherapy for treatment of the targeted larynx lesion.
• Synchronous primaries in the head and neck
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation fields.
• Subjects smoking in excess of 1 pack of cigarettes per day.
• Subjects may not be receiving any other investigational agents.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
National Liver Cancer Screening Trial (TRACER)
The National Liver Cancer Screening Trial is an adaptive randomized phase IV Trial comparing ultrasound-based versus biomarker-based screening in 5500 patients with cirrhosis from any etiology or patients with chronic hepatitis B infection. Eligible patients will be randomized in a 1:1 fashion to Arm A using semi-annual ultrasound and AFP-based screening or Arm B using semi-annual screening using GALAD alone. Randomization will be stratified by sex, enrolling site, Child Pugh class (A vs. B), and HCC etiology (viral vs. non-viral). Patients will be recruited from 15 sites (mix of tertiary care and large community health systems) over a 3-year period, and the primary endpoint of the phase IV trial, reduction in late-stage HCC, will be assessed after 5.5 years.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
• Adult patients ages 18-85 with cirrhosis from any etiology or with chronic hepatitis B with a PAGE-B score greater than 9 within 12 months of enrollment
• Patient is eligible for HCC surveillance according to treating physician or by the site investigator
• Able to provide informed consent
• Life expectancy \>6 months (after consent) as determined by the treating provider or site investigator
• Child Pugh C cirrhosis
• History or clinical symptoms of hepatocellular carcinoma or cholangiocarcinoma
• History of solid nodule on baseline ultrasound (i.e., lesion 1cm or greater) within 9 months prior to consent without subsequent diagnostic CT/MRI demonstrating benign nature)
• AFP \>20 ng/mL within 6 months prior to consent, in the absence of a contrast-enhanced CT or MRI within 6 months of AFP (before or after) level demonstrating lack of suspicious liver lesions
• Newly diagnosed LR-3 greater than or equal to 1 cm within 6 months prior to consent
• History of LR-4, LR-5, or LR-M on multi-phase CT or contrast-enhanced MRI within 6 months prior to consent
• Presence of another active cancer besides non-melanomatous skin cancer or indolent cancer under active surveillance (e.g., prostate cancer or renal cell carcinoma) within the 2 years prior to consent
• Patient's provider is planning to use MRI- or CT- based surveillance moving forward
• History of a transjugular intrahepatic portosystemic shunt (TIPS)
• History of Fontan associated liver disease or cardiac cirrhosis
• History of solid organ transplantation
• Actively listed for liver transplantation
• Diagnosis of alcohol-associated hepatitis within 3 months prior to consent
• Documented current or continued signs and symptoms of acute Wilson disease (acute liver failure, acute neurological deficits, hemolysis)
• In patients with primary sclerosing cholangitis (PSC): Current active cholangitis within 90 days prior to consent
• Known or documented habitual non-adherence to previous research studies or medical procedures or unwillingness to adhere to protocol (e.g., unwilling to obtain consent or samples)
• In patients living with HIV: CD4+ T cell count less than 100 cells/mm3 within 60 days prior to consent
• Known pregnancy at consent
• Active warfarin use