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434 Study Matches
[18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
This is a multi-center, open-label, single-arm, Phase 1/2 study designed to evaluate the safety, radiation dosimetry, and preliminary diagnostic performance of \[18F\]FPyQCP in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Steven Rowe
ALL
18 Years to 80 Years old
PHASE1
NCT07432633
STU20250096
Inclusion Criteria:
• Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.
• Participants must be ≥ 18 years and \< 80 years of age and competent to give informed consent.
• Eastern Cooperative Oncology Group performance status ≤ 2.
• Diagnosis of either CRC (confirmed by histopathology), GC (confirmed by histopathology), PDAC (confirmed by cytology or histopathology), ILC (confirmed by histopathology), or EOC (suspected or confirmed by cytology or histopathology).
• Women of childbearing potential (WOCBP) should have a negative serum test at screening (Visit 1) and a negative urine pregnancy test at the PET/CT imaging visit (Visit 2) prior to \[18F\]FPyQCP administration.
• WOCBP, and men who are sexually active with WOCBP, must agree to use a highly effective method(s) of contraception for the duration of the study
• Cohort A specific: Participants with stage I-III (see Appendix 3) CRC, GC, PDAC, ILC, or EOC (stage IV disease is allowed in the setting of oligometastatic disease \[5 or fewer known metastases) as assessed by conventional imaging within 8 weeks of \[18F\]FPyQCP administration.
• Cohort B specific: Conventional imaging performed within 8 weeks of screening and no later than 24 hours before \[18F\]FPyQCP administration and available for upload to the central imaging vendor, including, at a minimum, a contrast-enhanced CT that includes the abdomen and pelvis.
• Either:
• Treatment-naïve with at least stage IIB disease. Available biopsy sample or scheduled biopsy or surgical resection no later than Day 42.
• Following neoadjuvant therapy (with at least stage IIB disease at initial presentation) with scheduled biopsy or surgical resection no later than Day 42. \[18F\]FPyQCP PET/CT imaging should be performed as close to scheduled procedure as clinically feasible.
• Suspected recurrence after definitive therapy
Exclusion Criteria:
• Participants administered any radioisotope within 5 physical half-lives prior to \[18F\]FPyQCP administration.
• Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to \[18F\]FPyQCP administration.
• Participants who have recently received any other contrast agent (\< 24 hours for intravenous agents and \< 5 days for oral agents) before the day of \[18F\]FPyQCP administration.
• Participants with a history of severe claustrophobia or panic attacks when in confined spaces.
• Known hypersensitivity to \[18F\]FPyQCP or any of its constituents.
• Participants with any medical condition or other circumstances at screening or in their past medical history that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or study completion.
• Known diagnosis of an autoimmune or inflammatory disorder that is expected to confound image interpretation per investigator judgment, excluding disorders directly related to the index cancer (e.g. tumor-associated pancreatitis or biliary stasis for PDAC).
• Medical history of abdomino-pelvic or breast irradiation in the last 3 months.
• Presence of any current implanted foreign material (e.g. stents, surgical clips) that may confound image interpretation per investigator judgment.
• Significant renal or hepatic impairment.
• Female participants who are breastfeeding, unless the participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the \[18F\]FPyQCP administration.
• Cohort A Specific
Exclusion Criteria:
No prior history of any other cancer. DRUG: [18F]FPyQCP
Colorectal Cancer, Epithelial Ovarian Cancer, Gastric Cancer, Invasive Lobular Breast Carcinoma, Pancreatic Ductal Adenocarcinoma
Positron emission tomography, Fibroblast activation protein
UT Southwestern
IMPACT-MACS: Adrenalectomy vs Semaglutide for Metabolic Outcomes in Mild Autonomous Cortisol Secretion (IMPACT-MACS)
The goal of this study is to learn how two treatments-adrenalectomy (surgical removal of an adrenal gland) and semaglutide (a medication used for weight management)-affect insulin resistance and cortisol regulation in adults with mild autonomous cortisol secretion (MACS). The study will also learn how these treatments impact body composition, blood pressure, cholesterol, inflammation, muscle strength, and quality of life. The main questions the study aims to answer are: 1. Does adrenalectomy or semaglutide improve insulin resistance more in people with MACS? 2. How do these treatments change cortisol patterns and other cardiometabolic risk factors? 3. Do people with MACS respond differently to semaglutide compared to matched adults without MACS? Participants will: 1. Receive either adrenalectomy or semaglutide if they have MACS, or semaglutide if they are matched controls 2. Complete clinic visits and phone visits over about 26-30 weeks 3. Undergo metabolic testing such as blood tests, urine steroid profiling, body composition scans, blood pressure monitoring, muscle strength testing, and questionnaires about health and well-being
Call 214-648-5005
studyfinder@utsouthwestern.edu, MartinTzeWah.Kueh@UTSouthwestern.edu
Oksana Hamidi
ALL
18 Years to old
NA
NCT07361874
STU20251717
Inclusion Criteria:
* Adults ≥18 years
* MACS groups: adrenal adenoma + DST cortisol \>1.8 µg/dL + no overt Cushing + eligible for adrenalectomy
* Willingness to postpone surgery 6 months if randomized
* Controls: no adrenal abnormalities + normal DST + BMI ≥27 + ≥2 cardiometabolic conditions
* Stable medication doses for ≥4 weeks
* Negative pregnancy test if applicable
Exclusion Criteria:
* Prior GLP-1 RA within 90 days
* Weight change \>5 kg in past 90 days
* Prior obesity/diabetes surgery
* Type 1 diabetes or other diabetes types
* Severe organ disease
* Recent pancreatitis
* Pregnancy, breastfeeding
* Contraindication to semaglutide
* Contraindication to surgery delay
* Chronic glucocorticoid use PROCEDURE: Intervention 1: Adrenalectomy, DRUG: Intervention 2: Semaglutide
Mild Autonomous Cortisol Secretion (MACS), Autonomous Cortisol Secretion (ACS), Subclinical Cushing's, Mild Autonomous Cortisol Excess
Mild Autonomous Cortisol Secretion, MACS, Adrenal incidentaloma, Adrenal adenoma, Subclinical Cushing, Hypercortisolism, Cortisol dysregulation, Adrenalectomy, Semaglutide, Weight loss, Body composition, Insulin resistance, GLP-1 receptor agonist, Hyperinsulinemic-euglycemic clamp, Cortisol dynamics, Visceral fat, cardiometabolic risk, randomized controlled trial
UT Southwestern
Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy (RANGER) ((RANGER))
This Phase II, single arm study evaluates a PSA-response-adapted approach to salvage radiotherapy after radical prostatectomy for prostate cancer. All participants will receive hypo-fractionated stereotactic radiotherapy to the prostate fossa. At 5 weeks, biochemical response will be assessed. responders will proceed to observation, while non responders will receive sequential pelvic nodal radiotherapy and 4 months of androgen deprivation therapy (ADT). The study aims to determine whether this response base approach achieves non inferior 2 year freedom from progression compared with historical outcomes using routine pelvic nodal radiotherapy and ADT in all patients.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Aurelie Garant
MALE
18 Years to old
PHASE2
NCT07313241
STU20251220
Inclusion Criteria:
* Men aged ≥18 years with histologically confirmed prostate adenocarcinoma treated with prostatectomy in the localized setting within 10 years, with post-operative PSA (persistent or rising) of ≥0.05ng/mL.
* Radical prostatectomy ≥4 months prior to enrollment without nodal involvement (pN0 or pNx)
* Performance status ECOG 0-2
* No definite evidence of regional or distant metastatic disease by at least pelvic imaging within 90 days of registration. Equivocal findings are allowed at investigator discretion. Imaging is specified as follows:
* PSA\>=0.2ng/mL: positron emission tomography (PET) with FDA-approved advanced imaging agent for prostate cancer (e.g. PSMA) required.
* PSA \<0.2 n/gm: PET with above noted agents OR conventional CT or MRI at investigator discretion.
* All sexually active men must agree to use adequate contraception for the duration of study therapies and a period of 60 days thereafter. Should a female partner of a trial participant become pregnant or suspect she is pregnant while the subject is participating in this study, the patient should inform his treating physician immediately.
* Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
* Prior androgen deprivation therapy (ADT) \> 3 months OR anti-androgen therapy (AAT) of \> 30 days. For shorter courses of either, at least 30 day "wash out" period is required with confirmation of resolved castration of testosterone to \>50ng/mL.
* Ongoing testosterone replacement therapy (TRT) with refusal to discontinue (must be stopped with demonstration of detectable PSA ≥0.05ng/mL and non-castrate testosterone \>50ng/mL after 14 days of TRT cessation)
* Prior pelvic radiotherapy
* 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, in the opinion of the investigator, would limit compliance with study requirements.
* History of bladder neck or urethral stricture requiring procedural intervention.
* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to actively interfere with the safety or efficacy assessments of this study in the investigator's view.
* Active inflammatory bowel disease requiring recurring systemic or steroid/enema therapy RADIATION: Prostate Fossa Radiotherapy, RADIATION: Pelvic nodal Radiotherapy, DRUG: Androgen Deprivation Therapy (ADT)
Prostate Cancer, Prostate
UT Southwestern; Parkland Health & Hospital System
Phosphate Assessment in Chronic Kidney Disease Patients Study (PACK)
The proposed pilot feeding study aims to explore novel pathways in phosphate metabolism and identify new biomarkers, as well as to develop a compound index for assessing phosphate overload with high validity and reliability. Investigators will address the following specific aims: 1). To explore novel pathways of phosphate metabolism and assess the influence of CKD status on these metabolic pathways. 2). To identify novel biomarkers for phosphate overload that reflect changes in dietary phosphorus intake. 3). To develop a compound phosphate overload index that measures dietary phosphorus intake with high validity and reliability. This study will provide novel insights into phosphate metabolism and the assessment of phosphate overload in CKD patients. This investigation aims to provide preliminary data to further studies for the development of reliable biomarkers in CKD patients, which could contribute significantly to early interventions and improve health outcomes.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Paola.Lanza@UTSouthwestern.edu
Jing Chen
ALL
18 Years to old
NA
NCT07368946
STU-2024-1240
Inclusion Criteria:
* Men or women aged 18 years or older, of any race/ethnicity
* Women must either be post-menopausal or have no monthly menstrual cycle
* Estimated total daily energy expenditure (TDEE) of 1700 - 2700 calories
* eGFR \>15 ml/min/1.73m2 - \< 60 ml/min/1.73m2 for the CKD group (CKD Stage 3 or Stage 4)
* eGFR ≥ 60 ml/min/1.73m2 and negative urine protein on dipstick test for the non-CKD group
* English speaking
Exclusion Criteria:
* Pregnant, currently breastfeeding, or \<3 months postpartum
* Current dialysis or kidney transplant patient
* Current use of insulin or chemotherapy drugs
* Smokes cigarettes or uses e-cigarettes (vapes)
* Uses nicotine products or other recreational drugs
* Medical history of stroke or myocardial infarction (MI)
* Medical history of conditions that can affect phosphate metabolism (i.e., uncontrolled thyroid disorder, parathyroid disorder, or gastrointestinal malabsorption disorders \[Crohn's, ulcerative colitis, and celiac disease\], cirrhosis)
* Current use of certain medications that directly alter phosphate levels (i.e., phosphate binders; phosphate supplements, irregular use of iron)
* Regular use of laxatives
* Hypo- or hyperphosphatemia (serum phosphate \< 2.5 or \> 4.6 mg/dl)
* Hypo- or hypercalcemia (serum calcium \< 8.4 or \> 10.7 mg/dl)
* Severe anemia (hemoglobin \< 8 g/dl for women and \< 9 g/dl for men)
* Severe hyperglycemia (serum blood glucose \> 300 mg/dl)
* Body weight less than \<110 lbs (due to risk for phlebotomy-induced anemia)
* Received a blood transfusion in the last four months
* Extreme hypertension as demonstrated by a blood pressure \> 180/120 as the average of 3 blood pressures taken during the screening/baseline, or extremely low blood pressure \< 80/50
* Unwilling or unable to eat study meals
* Lack of access to a functional refrigerator or freezer
* Lack of access to a microwave or conventional oven
* On low potassium diet
* On low phosphate diet
* Specific dietary restrictions (i.e. vegetarian, vegan, ketogenic, etc.)
* Food allergies including but not limited to milk, egg, soy, nuts, shellfish, and wheat or gluten
* Allergic to sodium phosphate
* Unable or unwilling to complete urinary sample collection or food diaries
* Unable or unwilling to provide informed consent
* Unable to read or speak English
* Participant in other conflict clinical trial
* Unable to complete the study measurements
* Unsafe to participate in this study per investigator's judgement DIETARY_SUPPLEMENT: Dietary Phosphorus Intake
Chronic Kidney Disease (Stage 3-4), Chronic Kidney Disease Mineral and Bone Disorder
chronic kidney disease, study diet, feeding study, pilot, oral phosphate feeding
UT Southwestern
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)
A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants with Heart Failure with Preserved Ejection Fraction (HFpEF)
studyfinder@utsouthwestern.edu
ALL
50 Years to old
PHASE1
NCT07219511
Inclusion Criteria:
Participants must meet all inclusion criteria to be eligible for trial participation.
• Males or females ≥ 50 years of age at the time of signing the informed consent.
• Diagnosis of HFpEF as defined by European Society of Cardiology or American College of Cardiology/American Heart Association criteria
• NYHA Functional Class II or III
• LVEF ≥ 50% demonstrated by echocardiography (ECHO) performed at Screening with evidence of heart failure
• Elevated NT-proBNP at Screening
• NordicPRO-C6™ ≥ 11 ng/mL at Screening.
• Stable dose of all concomitant HF medications for at least 4 weeks prior to Screening.
• Body weight of at least 110 lbs (50 kg) and body mass index (BMI) within the range ≥ 18 to \< 45 kg/m2.
• Males must agree to the contraception requirements and females must be of non-childbearing potential
• Able to understand and willing to sign a written informed consent form (ICF).
• Willing and able to comply with trial procedures and restrictions listed in the ICF and in this protocol.
Exclusion Criteria:
• Female trial participant who is pregnant or breastfeeding.
• Known hypersensitivity to VS-041.
• Cardiovascular disease other than HFpEF
• Active intercurrent illness such as acute bacterial or viral infection.
• History of illicit drug or alcohol abuse or addiction that in the opinion of the PI could affect participation.
• Active chronic viral infection such as Hepatitis B, Hepatitis C or human immunodeficiency virus (HIV) at Screening.
• Acute decompensated HF within 30 days of Screening
• Lung disease within 12 months prior to Screening
• History of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
• History of any other condition including psychiatric disorders that, in the opinion of the PI, may preclude the participant from following and completing the protocol.
• Have participated within the last 6 months in a clinical study involving an investigational product.
• Any other reason which, in the opinion of the PI, would prevent the participant from participating in the trial.
DRUG: VS-041, OTHER: Placebo
Heart, Heart Failure With Preserved Ejection Fraction (HFpEF)
Heart Failure with Preserved Ejection Fraction, HFpEF
Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype (PERSEPHONE)
This is a parallel, Phase 2b/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: * Screening period of up to 4 weeks * Randomized intervention period of approximately 48 weeks * Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.
studyfinder@utsouthwestern.edu
ALL
40 Years to 80 Years old
PHASE3
NCT07190209
Inclusion Criteria:
* Between 40 to 80 years of age
* Physician diagnosed chronic obstructive pulmonary disease (COPD) ≥1 year
* Post-bronchodilator forced expiratory volume in 1 second (post-BD FEV1) ≥ 20% and ≤ 70% of predicted value and FEV1/FVC (forced expiratory volume in 1 second /forced vital capacity) \<0.70
* Former or current smokers ≥10 pack-years
* Chronic Airways Assessment Test (CAAT) ≥10
* ≥2 moderate or ≥1 severe COPD exacerbations in the prior year
* Triple (ICS+LABA+LAMA) COPD therapy ≥12 consecutive weeks
* EOS (blood eosinophil count) ≥ 150 cells/μL
* 18.0 ≤ Body Mass Index ≤ 40.0 kg/m2
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
* Asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS)
* Significant pulmonary disease other than COPD
* Long-term oxygen therapy \>4.0 L/min or requirement of \>2.0 L/min to maintain oxygen saturation \>88% at rest
* Unstable disorder that can impact participants safety or study outcomes
* Active or incompletely treated tuberculosis
* Current or past malignancies
* Concomitant therapies:
* long-term macrolides or phosphodiesterase Type 3 (PDE-3) or PDE-4 inhibitors unless on stable therapy for \>6 months
* any biologic therapy or systemic immunosuppressant within 4 months or 5 half-lives prior to Screening
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial DRUG: Lunsekimig, DRUG: Placebo
Chronic Obstructive Pulmonary Disease
Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a) (MOVE-Lp(a))
The purpose of this study is to evaluate the efficacy of muvalaplin in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke.
studyfinder@utsouthwestern.edu
ALL
18 Years to old
PHASE3
NCT07157774
Inclusion Criteria:
* Have Lp(a) ≥175 nanomoles per liter (nmol/L)
* Meet one of the following criteria:
* Have had a prior atherosclerotic cardiovascular disease (ASCVD) event (such as heart attack, stroke, or procedure to restore blood flow to the heart or other parts of the body) within 10 years prior to screening
* Are at risk for a first ASCVD event, defined as one or more of the following:
* Documented coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without a history of ASCVD event
* A high coronary artery calcium (CAC) score
* Reduced kidney function with diabetes
* Combination(s) of high risk factors
Exclusion Criteria:
* Have experienced a major cardiovascular event or surgery, such as heart attack, stroke, or procedure to restore blood flow to the heart or other parts of the body, within 90 days prior to screening or occurring between screening and randomization
* Are planning or expected to undergo a procedure to restore blood flow in the arteries or a major heart surgery during the study
* Have uncontrolled high blood pressure
* Have New York Heart Association (NYHA) class III or IV heart failure
* Have undergone a procedure to remove cholesterol from the blood within 90 days of screening, or have a planned procedure during the study
* Have severe kidney impairment
* Have had cancer within 5 years prior to screening DRUG: Muvalaplin, DRUG: Placebo
Elevated Lp(a), Atherosclerotic Cardiovascular Disease (ASCVD)
Personalized Radiotherapy for Individualized Treatment Strategies and Monitoring (PRISM) (PRISM)
To characterize feasibility, safety, and/or preliminary efficacy of personalized strategies to adapt standard radiotherapy treatments to individual patient responses.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Neil Desai
ALL
18 Years to old
PHASE1
NCT07139990
STU20251050
Inclusion Criteria:
Cohort A:
* \>=18 years old
* Performance status ECOG 0-2
* Extensive stage small cell lung cancer diagnosed by tissue biopsy within 180 days of registration.
* Patient must be planned for or receiving standard of care chemoimmunotherapy.
* Patient must have received no more than 3 cycles by time of study enrollment.
* Able and indicated according to investigator to receive thoracic radiotherapy
Cohort B:
* 18 years old
* Diagnosis of solid tumor malignancy with MRI-defined brain metastasis lesions (1-5 lesions allowed) within 60 days of registration
* Each brain metastasis lesion enrolled must be 2 - 5 cm, except brainstem lesions which may be 1.5 - 5cm in size.
Exclusion Criteria:
Cohort A:
⨀ Prior thoracic Radiotherapy
Cohort B:
* Prior whole brain Radiotherapy
* Prior surgical resection or focal radiotherapy of a target brain metastasis
* Leptomeningeal disease RADIATION: Cohort A: Extensive Stage Small Cell Lung Cancer (ES-SCLC) Thoracic Tumor PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy), RADIATION: Cohort B: Brain metastasis PULSAR (Personalized ultrahypofractionated stereotactic ablative radiotherapy)
Small Cell Lung Cancer Extensive Stage, Brain Metastases, Solid Tumor, Adult, Multiple
UT Southwestern
Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX) (TIMELY-PLEX)
The purpose of this research is to evaluate if early vs rescue Therapeutic Plasma Exchange (PLEX) treatment algorithm leads to better visual outcomes in severe Optic Neuritis and leads to better neurological disability outcomes in severe Transverse Myelitis.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Ana.Raicu@UTSouthwestern.edu
Peter Sguigna
ALL
18 Years to old
PHASE3
NCT07100990
STU20251584
Study Population and Setting
The proposal will recruit participants presenting to participating sites with severe ON or severe TM to two separate sub-trials. The detailed inclusion and exclusion criteria for each sub-trial are listed below:
Optic Neuritis Sub-Trial:
Inclusion criteria:
* ≥18 years of age
* MRI orbits demonstrating evidence of new T2 hyperintensity and/or post-gadolinium contrast enhancement of the optic nerve(s) and meeting the clinical criteria for Optic Neuritis
* Visual acuity 20/200 or worse
* Within 8 days of onset of visual symptoms
* Able to initiate PLEX within 72h of the first dose of HDCS (if randomized to the "Early PLEX" treatment arm)
* Able to sign and date informed consent form
* Willingness to comply with all study procedures and availability for the duration of the study
Exclusion criteria:
* Evidence of prior episode of optic neuritis in the affected eye (by history or ophthalmological evaluation)
* Ophthalmological comorbidity that would significantly affect best corrected visual acuity or visual fields
* Pregnancy
* Presence of any contraindication to receiving HDCS or PLEX, including, but not limited to, hemodynamic instability, significant bleeding/coagulopathy, or sepsis.
* Any medical condition that, in the opinion of the investigator, may interfere with the patient's participation in the trial, pose any added risk for the patient, or confound the assessment of the patient (including but not limited to concurrent neurological disease and/or medical comorbidity)
* Treatment with any investigational agent within 6 months of baseline or five half-lives of the investigational agent (whichever is longer)
* Ongoing/prior treatment with immune-modulating/immunosuppressive therapy including:
* Mycophenolate mofetil, azathioprine, methotrexate, fingolimod, siponimod, ponesimod, ozanimod, tocilizumab, satralizumab, eculizumab or ravulizumab within 3 months of randomization
* Anti-CD20 (rituximab, ocrelizumab, ofatumumab, ublituximab) or anti-CD19 (inebilizumab) therapy within 6 months of randomization
* Intravenous or subcutaneous immune globulin within 3 months of randomization
* Plasma exchange within 3 months of randomization
* Interferon-beta, glatiramer acetate, fumarates (dimethyl fumarate, monomethyl fumarate, diroximel fumarate) within 1 month of randomization
* Teriflunomide use within prior 24 months
* Systemic corticosteroid therapy (intravenous or oral; excluding inhaled or topical corticosteroids) within 1 month of randomization
* Any previous treatment with alemtuzumab, cladribine, mitoxantrone or cyclophosphamide
* Previous treatment with any immune-modulating or immunosuppressive therapy not mentioned above within 6 months of randomization or five-half-lives (whichever is longer)
Transverse Myelitis Sub-Trial:
Inclusion criteria:
* ≥18 years of age
* Diagnosis of Transverse Myelitis (defined based on modified criteria adapted from the 2002 Transverse Myelitis Consortium Working Group; ALL are required)
* Development of sensory, motor and/or autonomic symptomatology attributable to spinal cord dysfunction
* Onset of symptoms to nadir \>12 hours
* Exclusion of extra-axial compressive etiology by neuroimaging
* Demonstration of inflammation within the spinal cord by presence of intramedullary T2 lesion (post-gadolinium enhancing OR non-enhancing) on MRI
* Expanded Disability Status Scale \[EDSS\] ≥3.0 (excluding visual and cerebral functional systems)
* EDSS Pyramidal Functional System Score ≥ 2
* Within 8 days of onset of motor symptoms
* Able to initiate PLEX within 48h of the first dose of HDCS (if randomized to the "Early PLEX" treatment arm)
* Able to sign and date informed consent form
* Willingness to comply with all study procedures and availability for the duration of the study
Exclusion criteria:
* Pre-existing ambulatory, motor, sensory, or bowel/bladder disability of any cause that could confound trial assessments
* Fulfillment of possible, probable or definite spinal cord infarction diagnosis per proposed diagnostic criteria (Zalewski et al. JAMA Neurology 2018)
* History of radiation to the spine
* Pregnancy
* High clinical suspicion for infectious etiology of myelitis (e.g., fever, rash or other findings)
* Presence of any contraindication to receiving HDCS or PLEX, including, but not limited to, hemodynamic instability, significant bleeding/coagulopathy, or sepsis.
* Any medical condition that, in the opinion of the investigator, may interfere with the patient's participation in the trial, pose any added risk for the patient, or confound the assessment of the patient (including but not limited to concurrent neurological disease and/or medical comorbidity)
* Treatment with any investigational agent within 24 weeks of baseline or five half-lives of the investigational agent (whichever is longer)
* Ongoing/prior treatment with immune-modulating/immunosuppressive therapy including: Mycophenolate mofetil, azathioprine, methotrexate, fingolimod, siponimod, ponesimod, ozanimod, tocilizumab, satralizumab, eculizumab or ravulizumab within 3 months of randomization
* Anti-CD20 (rituximab, ocrelizumab, ofatumumab, ublituximab) or anti-CD19 (inebilizumab) therapy within 6 months of randomization
* Intravenous or subcutaneous immune globulin within 3 months of randomization
* Plasma exchange within 3 months of randomization
* Interferon-beta, glatiramer acetate, fumarates (dimethyl fumarate, monomethyl fumarate, diroximel fumarate) within 1 month of randomization
* Teriflunomide use within prior 24 months
* Systemic corticosteroid therapy (intravenous or oral; excluding inhaled or topical corticosteroids) within 1 month of randomization
* Any previous treatment with alemtuzumab, cladribine, mitoxantrone or cyclophosphamide
* Previous treatment with any immune-modulating or immunosuppressive therapy not mentioned above within 6 months of randomization or five-half-lives (whichever is longer)
DRUG: High-dose corticosteroids (HDCS), DRUG: High-dose corticosteroids (HDCS) and PLEX
Optic Neuritis, Myelitis, Myelitis, Transverse
Plasma Exchange, Plasmapheresis, Apheresis, Pheresis
UT Southwestern
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer (EmpowHER 208)
The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Heather McArthur
ALL
18 Years to old
PHASE2
NCT07102381
STU20251841
Inclusion Criteria:
• Has Stage II or III histologically confirmed invasive breast carcinoma.
• Has histologically confirmed HER2-positive breast cancer
• Has a known hormone receptor (HR) status of the primary tumor
• Participants with multifocal or multicentric disease are eligible if the largest tumor (which must be larger than or equal to 2 cm in diameter) is HER2-positive, and the treating physician has determined the participant should be treated as HER2-positive.
• Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ function
• Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 4 weeks prior to first dose of study intervention.
• Adequate contraceptive precautions
Exclusion Criteria:
• Has Stage IV (metastatic) breast cancer.
• Has bilateral breast cancer.
• Has a history of any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the participant's involvement in the study.
• Has uncontrolled hypertension
• Has significant symptoms from peripheral neuropathy
• Has an active uncontrolled infection
• Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab or other study interventions.
• Known active hepatitis B or C infection.
• Has another malignancy diagnosed within the last 5 years. Exceptions include previously treated non melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ.
• Was treated with chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer
• Is planning to receive concurrent therapy with any other investigational agent or anti-cancer therapy not specified in the protocol
• Receipt of a live vaccine within 4 weeks prior to enrollment
• Has a known hypersensitivity to any components of the study interventions, including chemotherapy
DRUG: Zanidatamab, DRUG: Paclitaxel, DRUG: Docetaxel, DRUG: Carboplatin, DRUG: Trastuzumab, DRUG: Pertuzumab
HER2-positive Breast Cancer, Breast Cancer, Breast - Female
HER2-positive early breast cancer, invasive breast carcinoma, zanidatamab, breast neoplasm
UT Southwestern
Periprostatic Neurolysis in Prostate Cancer
The purpose of this research study is to assess whether inhibiting nerve activity to the prostate delays progression of disease in men with high-risk clinical features for prostate cancer. Prostate cancer has been shown to invade nerves, a mechanism that is thought to be involved in prostate cancer spread in men with high-risk cancer. When nerve activity to the prostate is blocked in mice with prostate cancer, prostate cancer growth and spread are inhibited. In a previous study we showed that doing so in humans was safe and may have anticancer therapeutic effect. In this study we will test whether one versus two injections of nerve blocking agent is more effective at reducing nerves in the prostate and whether it will slow/stop spread of prostate cancer after treatment.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Ali.Zahalka@UTSouthwestern.edu
Ali Zahalka
MALE
18 Years to old
PHASE1
NCT07100847
STU20240058
Inclusion criteria:
High risk prostate cancer as defined by NCCN criteria Desires surgical disease treatment (radical prostatectomy) Surgical candidate (for radical prostatectomy)
≤cT3a on MRI No seminal vesicle, lymph node, or metastatic disease on PSMA PET No prior prostate cancer treatment (including androgen deprivation therapy, radiation therapy, focal therapy, cryo therapy)
PROCEDURE: Periprostatic neurolysis with dehydrated alcohol (ethanol)
Prostate Cancer, NERVES, NEUROBIOLOGY OF CANCER, NEUROLYSIS, Prostate
HIGH RISK LOCALIZED PROSTATE CANCER
UT Southwestern
Luspatercept + Darbepoetin in MDS (DarbeLus)
This is a single arm open-label Phase II trial of luspatercept and darbepoetin alfa in non-mutated SF3B1 , lower-risk, RBC transfusion dependent MDS participants with an endogenous erythropoietin (EPO) level \< 500 IU/L.
Michael Mccane michael.mccane@utsouthwestern.edu
ALL
18 Years to old
PHASE2
NCT07096297
Inclusion Criteria:
• Ability to understand and the willingness to sign a written informed consent document.
• Participant is 18 years or older at the time of signing informed consent.
• Participant has lower-risk myelodysplastic syndrome (MDS) defined as very low, low and intermediate risk by International Prognostic Scoring System-Revised (IPSS-R) criteria (3).
• Bone marrow biopsy within 90 days of screening demonstrated less than 5% blasts in the aspirate and/or core biopsy. If no bone marrow biopsy was done within 90 days of screening it is mandatory to repeat it at screening. Otherwise, bone marrow biopsy is optional at screening to obtain correlative study samples.
• Absence of SF3B1 mutation and del5q.
• Endogenous serum erythropoietin alfa (EPO) level \< 500 IU/L.
• Participant is transfusion dependent defined as ≥ 2 packed red blood cell (PRBC) units/8 weeks for a minimum of eight weeks immediately prior to screening. The maximum consecutive timeframe participants may be RBC transfusion-free within this 8-week time period is six weeks. a. Red blood cell transfusions administered when hemoglobin levels were \> 9.0 g/dL and/or RBC transfusions administered for elective surgery, infections or bleeding events will not be counted in above.
• Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (Appendix 1. ECOG Performance Status Scale).
• Participant has adequate organ function defined as:
• Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3 x ULN, unless considered due to organ involvement by the participant's myeloid malignancy (in that case a cut off ≤ 5 x ULN will be used).
• Serum direct bilirubin \< 1.5 x ULN.
• Creatinine clearance \> 30 mL/min based on the Cockroft-Gault glomerular filtration rate (GFR) estimation.
• Participants must adhere to the following reproductive and contraceptive requirements while on study treatment and for three months after the last dose of luspatercept and darbepoetin alfa: a. General Requirements: i. Participants must not be pregnant or breastfeeding. ii. Participants must not donate gametes (i.e., eggs or sperm) or freeze gametes for future use related to assisted reproduction. b. For participants of childbearing potential: i. Participant of childbearing potential is defined as an individual who is premenopausal and capable of becoming pregnant, including those using contraception, those who are single, or those with partners who have had a vasectomy. ii. A negative highly sensitive pregnancy test must be obtained at screening, and a negative serum or urine pregnancy test must be obtained within 72 hours starting on treatment, and participants must agree to further pregnancy tests throughout the study as required per the site's institutional guidelines. iii. Participants must agree to use two methods of contraception of which one must be highly effective for three months after the last dose of luspatercept and darbepoetin alfa. c. For Partners of Participants: i. If the participant's partner is of childbearing potential, the partner must also practice a highly effective method of contraception while the participant is on study treatment and for three months after the last dose of luspatercept and darbepoetin alfa, unless the participant is vasectomized. d. Highly effective methods of contraception include, but are not limited to: i. Combined hormonal contraception (estrogen and progestogen) that inhibits ovulation (oral, intravaginal, or transdermal). ii. Progestogen-only hormonal contraception that inhibits ovulation (oral, injectable, or implantable). iii. Non-hormonal (cooper) intrauterine device (IUD). iv. Intrauterine hormone-releasing system. v. Bilateral tubal occlusion. vi. Sexual abstinence (the reliability of abstinence must be evaluated concerning the duration of the clinical study and the participant's lifestyle). vii. A vasectomized partner (provided the partner is the sole sexual partner of the study participant of childbearing potential and that the vasectomized partner has received medical confirmation of the surgical success).
Exclusion Criteria:
• Prior treatment with ESA, luspatercept, hypomethylating agents or lenalidomide/thalidomide/other immunomodulating drug (IMiDs).
• Exception 1: Participants can have received ≤ 2 doses of prior epoetin alfa or ≤ 1 dose darbepoetin alfa if ≥ 8 weeks from date of consent.
• Exception 2: Participants can have received ≤ 1 week of treatment with lenalidomide ≥ 8 weeks from the date of consent, at the sponsor-investigator's discretion.
• After signing consent, the participants are not allowed to receive any of these drugs: other RBC hematopoietic growth factors (e.g., Interleukin-3), granulocyte colony stimulating factors (i.e., G-CSF, GM-CSF), except in cases of neutropenic fever, cytotoxic, chemotherapeutic, targeted or investigational agents/therapies, azacitidine, decitabine or other hypomethylating agents, lenalidomide, thalidomide and other immunomodulating drugs (IMiDs), hydroxyurea, androgens, unless to treat hypogonadism, oral retinoids (topical retinoids are permitted), arsenic trioxide, interferon and interleukins.
• Participants with history of seizures at any time.
• Participants with any of the following conditions within six months prior to screening:
• Stroke.
• Thrombosis/thromboembolism.
• Myocardial infarction.
• Uncontrolled angina.
• Acute decompensated cardiac failure or New York Heart Association (NYHA) Class III-IV heart failure.
• Uncontrolled cardiac arrhythmia as determined by the investigator.
• Participant has immediate life-threatening, severe complications of their myeloid malignancy such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation.
• Participants with uncontrolled hypertension defined as systolic blood pressure (SBP) of ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment. Participant with history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack.
• Participant has active viral infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or active infection with hepatitis C virus (HCV). Participants with HIV that is controlled (not detectable viral load) with highly active antiretroviral therapy (HAART) are eligible to participate.
• Participant has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment).
• Participant who is pregnant or lactating.
• Pregnant participants are excluded from this study because luspatercept has shown in animal studies to be potentially associated with fetal harm.
• Because there is an unknown but potential risk for AE in nursing infants secondary to treatment, lactating participants are excluded from this study.
• Participant with prior history of malignancies, other than MDS, unless the participant has been free of the disease for ≥ 5 years. However, participants with the following history/concurrent conditions are allowed:
• Basal or squamous cell carcinoma of the skin.
• Carcinoma in situ of the cervix.
• Carcinoma in situ of the breast.
• Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis TNM clinical staging system).
DRUG: Luspatercept, DRUG: Darbeopoetin
MDS (Myelodysplastic Syndrome)
SF3B1 wild type, RBC transfusion dependent, lower risk, non-mutated SF3B1
EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease
This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin. Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo. Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Jovana.Valdez@UTSouthwestern.edu
Ildiko Lingvay
ALL
18 Years to old
PHASE3
NCT07064473
STU20251252
Inclusion Criteria :
* At least 18 years old at time of consent
* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
* Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).
* Participants with medical history of hypertension and on active pharmacological treatment
* Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment
* Established cardiovascular (CV) disease and on active pharmacological treatment
* At least one additional risk factor for developing heart failure (HF)
Exclusion Criteria:
* History of HF or hospitalization for HF or treatment of HF
* Atrial fibrillation or Atrial flutter with a resting heart rate \>110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)
* Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)
* Treatment with an Mineralocorticoid receptor antagonist (MRA)
* Treatment with amiloride or other potassium-sparing diuretic
* Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial:
* A direct renin inhibitor (e.g. aliskiren)
* More than one Angiotensin-converting enzyme inhibitor (ACEi) and/or Angiotensin receptor blocker (ARB) (including Angiotensin receptor-neprilysin inhibitor (ARNi)) used simultaneously
* Other aldosterone synthase inhibitors (e.g. baxdrostat)
* Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) Further exclusion criteria apply. DRUG: Vicadrostat, DRUG: Empagliflozin, DRUG: Placebo matching Vicadrostat
Diabetes Mellitus, Type 2, Hypertension, Cardiovascular Diseases
UT Southwestern
Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial
This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator. The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Giving pembrolizumab in combination with radiation therapy after neoadjuvant chemotherapy may help prevent surgical removal of the bladder in patients with muscle invasive bladder cancer.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Suzanne Cole
ALL
18 Years to old
PHASE2
NCT07061964
STU20252024
Inclusion Criteria:
* Participants must have histologic evidence of cT2-T4aN0M0 muscle invasive urothelial carcinoma of the bladder within 180 days prior to starting neoadjuvant therapy (NAT)
* Participants must have had CT chest/abdomen/pelvis (C/A/P), MRI C/A/P or PET within 60 days prior to starting NAT to determine cT2-T4aN0M0
* Participants must have undergone TURBT with biopsy of areas of prior disease and systematic biopsies (left and right lateral, dome, posterior wall and trigone) and radiologic staging showing clinically T0-T1 disease within 60 days after the last dose of NAT. At least 4 out of 5 systematic biopsies must be performed
* NOTE: This TURBT must be within 90 days prior to registration. Registration must be within 90 days after the last dose of NAT
* Participants must have imaging of the chest, abdomen, and pelvis performed using CT or MRI preferably with contrast. Fludeoxyglucose F-18 (FDG) PET-CT can also be used for staging. If FDG PET-CT is used, then it is at the discretion of the investigator if they want to additionally obtain diagnostic CT or MRI with contrast within 60 days after the last dose of NAT
* Participants with lymph nodes ≥ 1.0 cm in the shortest cross-sectional diameter on imaging (CT or MRI of abdomen and pelvis) after completion of NAT must have a PET-CT within 70 days prior to registration. A biopsy in the setting of negative PET-CT is not required unless there is strong clinical suspicion for nodal involvement with tumor. Participants with a positive PET are deemed ineligible unless a biopsy is performed and shows no evidence of tumor involvement
* NOTE: For questions regarding the above eligibility criteria, please contact the study chairs in addition to the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC)
* Participants must not have evidence of ≥ T2, or N1-3, or M1 disease after NAT
* Participants must not have the presence of small cell, neuroendocrine carcinoma, plasmacytoid variants on any pathology
* Participants must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within 24 months prior to registration except Ta/T1/carcinoma in situ (CIS) of the upper urinary tract, including renal pelvis or ureter if the participant underwent complete nephroureterectomy
* NOTE: Participants with mixed variant histology will be eligible for the trial if the majority (\> 50%) of the tumor is urothelial cell carcinoma
* Participants will be allowed to continue PD-1/L-1 inhibitor therapy received as part of standard of care neoadjuvant therapy while they undergo pre-registration assessments (TURBT and imaging)
* Participants must have received at least 3 and no more than 6 cycles of Food and Drug Administration (FDA) approved NAT for MIBC. These include cisplatin-based combination chemotherapy (e.g. cisplatin and gemcitabine \[GC\] with or without PD-1/L1 inhibitors) dose dense or accelerated methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) or enfortumab vedotin with PD-1/L1 inhibitor
* Participants must not have had anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody, any other antibody or drug targeting T-cell co-stimulation, enfortumab vedotin, or any other drug targeting nectin-4 other than for neoadjuvant treatment for MIBC
* NOTE: Prior intravesical immunotherapy or chemotherapy for non-muscle invasive disease is allowed
* Participants must not have had prior pelvic radiotherapy
* Participants must not have received a live attenuated vaccination within 28 days prior to registration
* Participants with conditions requiring immunosuppressive doses of steroids (\> 10 mg/day of prednisone or equivalent) or other immunosuppressive medications must not be taking steroids at time of trial registration
* Participants must be ≥ 18 years old at the time of registration
* Participants must have Zubrod performance status of 0-2
* Participants must have a complete medical history and physical exam within 28 days prior to registration
* Leukocytes ≥ 3 x 10\^3/uL (within 28 days prior to registration)
* Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to registration)
* Platelets ≥ 100 x 10\^3/uL (within 28 days prior to registration)
* Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration)
* Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to registration)
* Participants must have a creatinine ≤ the institutional (I)ULN OR measured OR calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better
* Participants with a history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration
* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured (defined as undetectable HCV viral load)
* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
* Participants must be offered the opportunity to participate in specimen banking
* Participants who can complete the PRO-CTCAE questionnaire in English or Spanish will be offered the opportunity to participate in the optional patient-reported outcome study
* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
* For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and central institutional review board (CIRB) regulations PROCEDURE: Biospecimen Collection, PROCEDURE: Computed Tomography, PROCEDURE: Cystoscopy, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Pembrolizumab, RADIATION: Photon Beam Radiation Therapy, PROCEDURE: Positron Emission Tomography, OTHER: Questionnaire Administration, PROCEDURE: Transurethral Resection of Bladder Tumor
Muscle Invasive Bladder Urothelial Carcinoma, Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8, Urinary Bladder
UT Southwestern
Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
This phase III trial compares the addition of induction chemotherapy, with carboplatin, paclitaxel and pembrolizumab, to chemotherapy and radiation, with cisplatin and pembrolizumab followed by pembrolizumab maintenance for the treatment of patients with cervical cancer that has spread to nearby tissue or lymph nodes (locally advanced). Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding induction chemotherapy to the usual treatment of chemotherapy and radiation followed by maintenance may be more effective in treating patients with high risk, locally advanced cervical cancer.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Jayanthi Lea
FEMALE
18 Years to old
PHASE3
NCT07061977
STU20252085
Inclusion Criteria:
* Patients must have pathologically confirmed newly diagnosed cervical cancer. Eligible pathologic types: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
* Patients must have locally advanced cervical cancer (LACC) with T3 or T4 disease with or without lymph node involvement:
* IIIA (T3aN0M0)
* IIIB (T3bN0M0)
* IIIC1(T3aN1M0, T3bN1M0)
* IIIC2 (T3aN2M0, T3bN2M0)
* IVA (T4aN0M0, T4aN1M0, T4aN2M0) No prior hysterectomy defined as removal of the entire uterus.
* NOTE: prior partial/subtotal hysterectomy for reasons other than cervical cancer are eligible to participate in the study. No plan to perform a hysterectomy as part of initial cervical cancer therapy.
No paraaortic lymph node (PALN) metastases above the T12/L1 interspace.
* Note: Nodal status can be confirmed by imaging (CT, MRI, or PET/CT), fine needle aspirate/core biopsy, extra peritoneal biopsy, laparoscopic biopsy, or lymphadenectomy.
Radiologic definition of lymph node staging:
* N1:
* One or more pelvic lymph nodes with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and/or
* One or more pelvic lymph nodes with short axis diameter of ≥ 10 mm and standardized uptake value maximum (SUVmax) ≥ 2.5 by fludeoxyglucose (FDG)-PET
* N2:
* One or more para-aortic lymph node with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and/or
* One or more para-aortic lymph node with short axis diameter of ≥ 10 mm and SUVmax ≥ 2.5 by FDG-PET
* No prior definitive surgical, radiation, or systemic therapy for cervical cancer
* No prior immunotherapy
* No prior pelvic radiation therapy for any disease
* Age ≥ 18
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Not pregnant and not nursing
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
* Platelets ≥ 100,000 cells/mm\^3
* Hemoglobin ≥ 8 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobulin \[Hgb\] ≥ 8 g/dl is acceptable)
* Creatinine clearance (CrCL) of ≥ 50 mL/min by the Cockcroft-Gault formula
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* No active infection requiring parenteral antibiotics
* No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacille Calmette Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed
* No diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior registration
* No active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed
* No history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
* No history of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients) PROCEDURE: Biospecimen Collection, RADIATION: Brachytherapy, DRUG: Carboplatin, PROCEDURE: Chest Radiography, DRUG: Cisplatin, PROCEDURE: Computed Tomography, RADIATION: External Beam Radiation Therapy, RADIATION: Intensity-Modulated Radiation Therapy, PROCEDURE: Magnetic Resonance Imaging, DRUG: Paclitaxel, BIOLOGICAL: Pembrolizumab, PROCEDURE: Positron Emission Tomography
Locally Advanced Cervical Adenocarcinoma, Locally Advanced Cervical Adenosquamous Carcinoma, Locally Advanced Cervical Squamous Cell Carcinoma, Stage IIIA Cervical Cancer FIGO 2018, Stage IIIB Cervical Cancer FIGO 2018, Stage IIIC1 Cervical Cancer FIGO 2018, Stage IIIC2 Cervical Cancer FIGO 2018, Stage IVA Cervical Cancer FIGO 2018, Cervix
UT Southwestern
A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of Niemann-Pick Type C Disease, GM1 Gangliosidosis or GM2 Gangliosidosis
An 18-month double-blind, randomized, placebo-controlled, multicenter, Phase 3 study to evaluate the safety and efficacy of oral nizubaglustat (AZ-3102) in late-infantile and juvenile forms of Niemann-Pick type C disease and in late-infantile and juvenile-onset forms of GM1 gangliosidosis or GM2 gangliosidosis
studyfinder@utsouthwestern.edu
ALL
4 Years to old
PHASE3
NCT07054515
Inclusion Criteria:
* Male and female participants, aged 4 years and older with a diagnosis of the late-infantile or juvenile form of NPC disease. Detailed inclusion criteria are presented in the NPC disease-specific subprotocol AZA-001-301-NPC (NCT07082725).
* Male and female participants, aged 4 years and older with a diagnosis of GM1 or GM2 (Tay-Sachs, Sandhoff, or GM2AB variant disease) gangliosidosis of late-infantile/ juvenile onset. Detailed inclusion criteria are presented in the GM1/GM2 gangliosidosis-specific subprotocol AZA-001-301-GMx (NCT07082543).
Exclusion Criteria:
* Detailed exclusion criteria are presented in the NPC disease-specific subprotocol AZA-001-301-NPC
* Detailed exclusion criteria are presented in the GM1/GM2 gangliosidosis-specific subprotocol AZA-001-301-GMx DRUG: AZ-3102, DRUG: Placebo
Niemann-Pick Type C Disease, GM1 Gangliosidosis, GM2 Gangliosidosis
Nizubaglustat
A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of Niemann-Pick Type C Disease (NPC)
An 18-month double-blind, randomized, placebo-controlled, multicenter, Phase 3 study to evaluate the safety and efficacy of oral nizubaglustat (AZ-3102) in late-infantile and juvenile forms of Niemann-Pick type C disease
studyfinder@utsouthwestern.edu
ALL
4 Years to old
PHASE3
NCT07082725
Inclusion Criteria:
* Signed informed consent
* Confirmed diagnosis of NPC disease
* Patient is unable or unwilling to take miglustat, or is, in the opinion of the investigator, unsatisfactorily treated with miglustat
* Male and female participants aged 4 years and older at the time of informed consent
* Onset of neurological symptoms from 2 to 15 years
* Disability level at Baseline: Ataxic disturbances with a total SARA score of ≥3 and ≤30 at Baseline
* Female of childbearing potential who are sexually active willing to follow the contraceptive guidance
* Male participants with a female partner of childbearing potential willing to follow the contraceptive guidance
Exclusion Criteria:
* A history of medical conditions other than NPC disease that, in the opinion of the Principal Investigator, would confound scientific rigor or the interpretation of results
* Body weight of \<10 kg
* The presence of another neurologic disease
* The presence of moderate or severe hepatic impairment
* The presence of moderate or severe renal impairment
* Platelet count of \<100x10\^9/L
* The dose of any anti-epileptic treatment(s) was not stable (required a change in dose within the previous 3 months) and/or a new anti-epileptic treatment (drug or procedure) was prescribed in the month before Baseline
* Prior use of an investigational drug within the 3 months before Screening; or prior participation in a clinical study involving gene therapy or stem cell transplantation within 2 years prior to Screening
* A positive serum pregnancy test (for women of childbearing potential)
* Current treatment with miglustat, provided the patient has been using the recommended dose for most of the past 12 months AND is, in the opinion of the investigator, satisfactorily treated with miglustat. Any participants receiving miglustat are required to undergo a 1-month washout period before starting study medication DRUG: Nizubaglustat, DRUG: Placebo
Niemann-Pick Type C Disease
Nizubaglustat
A Study to Evaluate the Safety and Efficacy of Oral Nizubaglustat (AZ-3102) in Late-infantile and Juvenile Forms of GM1 Gangliosidosis or GM2 Gangliosidosis
An 18-month double-blind, randomized, placebo-controlled, multicenter, Phase 3 study to evaluate the safety and efficacy of oral nizubaglustat (AZ-3102) in late-infantile and juvenile forms of GM1 gangliosidosis or GM2 gangliosidosis
studyfinder@utsouthwestern.edu
ALL
4 Years to old
PHASE3
NCT07082543
Inclusion Criteria:
* Confirmed GM1 gangliosidosis or Tay-Sachs, Sandhoff, or GM2AB variant
* Male and female participants aged 4 years and older at the time of informed consent
* Onset of neurological symptoms from 1 to 10 years
* Disability level at Baseline: Ataxic disturbances with a total SARA score of ≥3 and ≤30 at Baseline
* Females of childbearing potential who are sexually active willing to follow the contraceptive guidance
* Male participants with a female partner of childbearing potential willing to follow the contraceptive guidance
Exclusion Criteria:
* A history of medical conditions other than GM1 or GM2 gangliosidosis that, in the opinion of the Principal Investigator, would confound scientific rigor or the interpretation of results
* Body weight of \<10 kg
* The presence of another neurologic disease
* The presence of moderate or severe hepatic impairment
* The presence of moderate or severe renal impairment
* Platelet count of \<100x10\^9/L
* The dose of any anti-epileptic treatment(s) was not stable (required a change in dose within the previous 3 months) and/or a new anti-epileptic treatment (drug or procedure) was prescribed in the month before Baseline
* Prior use of an investigational drug within the 3 months before Screening; or prior participation in a clinical study involving gene therapy or stem cell transplantation within 2 years prior to Screening
* A positive serum pregnancy test (for women of childbearing potential) DRUG: AZ-3102, DRUG: Placebo
Gangliosidoses, GM2, Gangliosidosis, GM1
Nizubaglustat
A Polypill for Acute Coronary Syndrome (PolyACS)
The current study aims to investigate whether combining the standard medications prescribed after acute coronary syndrome (ACS)-aspirin, P2Y12 inhibitors, and statins-into a single polypill can improve outcomes following an ACS event. Although these therapies are effective, gaps in adherence and uptake significantly contribute to risk or adverse events in the post-ACS period. This study is designed as a pragmatic, multi-center, randomized trial to assess the feasibility and effectiveness of a polypill-based strategy for treatment of ACS.
Call 214-648-5005
studyfinder@utsouthwestern.edu, JuanDavid.CoellarPauta@UTSouthwestern.edu
Ambarish Pandey
ALL
18 Years to old
PHASE2
NCT07032389
STU-2024-0861
Inclusion Criteria:
* Age ≥ 18
* Hospitalization for acute coronary syndrome with percutaneous coronary intervention
* Discharged on aspirin, prasugrel or clopidogrel, and a high-intensity statin
Exclusion Criteria:
* Current need for systemic anticoagulation
* Contraindication to receive any components of the polypill
* History of allergic reaction or intolerance to aspirin, prasugrel or clopidogrel, or rosuvastatin
* Comorbidities that might be expected to limit lifespan within the 12-month study period
* Increased risk of bleeding or planned urgent surgery that would necessitate use of DAPT for \< 12 months
* Inability to provide written informed consent
* Pregnancy COMBINATION_PRODUCT: Polypill
Acute Coronary Syndrome, Cardiovascular
Acute Coronary Syndrome, Polypill, Adherence
UT Southwestern; Parkland Health & Hospital System
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity (MARITIME-CV)
The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Alyssa.Serrano@UTSouthwestern.edu
Alvin Chandra
ALL
45 Years to 99 Years old
PHASE3
NCT07037433
STU20250478
Inclusion Criteria
* Age ≥ 45 years at screening.
* BMI of ≥ 27.0 kg/m\^2 at screening.
* History of Atherosclerotic Cardiovascular Disease (ASCVD) with a documented history of at least one of the following:
* Prior MI (presumed atherothrombotic event due to plaque rupture/erosion).
* Prior ischemic stroke (presumed due to atherosclerosis; may include ischemic stroke with hemorrhagic transformation).
* Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) \< 0.9 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease.
Exclusion Criteria
* History of any of the following within 60 days before screening or between screening and randomization: MI, hospitalization for unstable angina, arterial revascularization (eg, coronary, cerebrovascular or peripheral) major cardiovascular surgery, stroke, or transient ischemic attack (TIA).
* New York Heart Association (NYHA) class IV HF during screening or hospitalization for HF within 60 days before screening or between screening and randomization.
* Type 1 DM, or any other type of diabetes with the exception of T2DM or prior gestational diabetes. Participants with a history of gestational diabetes should be stratified according to their current diabetes classification.
* For participants with T2DM (including those without a prior history of T2DM but with a HbA1c ≥ 6.5% during screening):
* HbA1c \> 10.0% (86 mmol/mol) at screening.
* History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before randomization.
* One or more episodes of severe hypoglycemia within 6 months before randomization and/or history of hypoglycemia unawareness.
* History of proliferative diabetic retinopathy, diabetic maculopathy, severe non-proliferative diabetic retinopathy, or currently receiving or planning to receive treatment for diabetic retinopathy and/or diabetic macular edema.
* Use of any glucagon-like peptide-1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days before randomization or planned use during the conduct of the trial.
* History of chronic pancreatitis or history of acute pancreatitis in the 180 days before screening or between screening and randomization.
* Family (first-degree relative\[s\]), or personal history of medullary thyroid carcinoma (MTC), or multiple endocrine neoplasia syndrome type 2 (MEN-2).
* Calcitonin ≥ 50 ng/L (pg/mL) at screening.
* Acute or chronic hepatitis; signs and symptoms of any liver disease other than metabolic dysfunction-associated steatotic liver disease, or alanine aminotransferase (ALT) \> 3.0 x the upper limit of normal (ULN) during screening, or total bilirubin (TBL) \> 1.8 x ULN during screening (for participants with a known diagnosis of Gilbert syndrome, direct bilirubin should be used instead of TBL).
* History of malignancy within the last 5 years before screening or between screening and randomization (except for the following treated with curative intent: non-melanoma skin cancer, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ).
* Participants of childbearing potential planning to become pregnant while on study or unwilling to use protocol-specified methods of contraception during treatment.
DRUG: Maridebart Cafraglutide, DRUG: Placebo
Atherosclerotic Cardiovascular Disease, Overweight, Obesity
Atherosclerotic Cardiovascular Disease, Overweight, Obesity, Maridebart cafraglutide, AMG 133, MariTide
UT Southwestern
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1 amplification). Main questions to answer include: * What is the recommended dose for expansion and/or Phase 2 * What medical issues/symptoms do participants experience when taking NKT5097
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Nisha Unni
ALL
18 Years to old
PHASE1
NCT07029399
STU20251544
Inclusion Criteria:
* Able to provide written informed consent
* Advanced unresectable or metastatic solid tumor
* Refractory to or unable to tolerate existing therapies (Part 1 \& 2 only)
* Measurable or evaluable disease (Part 1 \& 2 only)
* Eighteen years of age or older
* ECOG status of 0 or 1
* Adequate organ function
* Patients with female reproductive organs must be surgically sterile, post- menopausal or willing to use effective contraception per protocol
* Patients who are capable of insemination must be willing to use highly effective contraception and to refrain from sperm donation during treatment and for 28 days after the last dose
* Able to swallow oral meds
* Willing to provide tumor tissue
Exclusion Criteria:
* Advanced solid tumor that is a candidate for curative treatment
* History of another malignancy except for the following: adequately treated local basal cell or squamous carcinoma of the skin, in situ cervical cancer, adequately treated papillary noninvasive bladder cancer, other adequately treated Stage I or Stage II cancers currently in complete remission
* Not recovered from the effects of prior anticancer therapy
* Clinically significant cardiovascular event, including myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism, within 6 months
* Known active CNS metastases and/or carcinomatous meningitis
* Active interstitial lung disease requiring treatment
* History of uveitis, retinopathy, or other clinically significant retinal disease
* Major surgery within 30 days of administration of first dose
* Active uncontrolled infectious disease
* Significant liver disease (Child Pugh class B or C) DRUG: NKT5097 CDK2/CDK4 dual degrader
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC), CCNE1 Amplified Advanced Solid Tumors, HR+ HER2- Breast Cancer, Ovarian Cancer, Endometrial Cancer, Uterine Carcinosarcoma, Breast - Female, Breast - Male, Cervix, Colon, Corpus Uteri, Esophagus, Kidney, Liver, Lung/Thoracic, Other Digestive Organ, Other Endocrine System, Other Female Genital, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Urinary, Ovary, Pancreas, Prostate, Small Intestine, Stomach, Urinary Bladder, Uterine (Endometrial)
CCNE1, cyclin E1, triple negative breast cancer, TNBC, estrogen receptor positive, HER2-, breast cancer, advanced solid tumors, post CDK4/6i, HER2 expression
UT Southwestern
Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.
studyfinder@utsouthwestern.edu
ALL
1 Year to 3 Years old
PHASE3
NCT07003919
Key
Inclusion Criteria:
* Aged 1 through 3 years at Visit 1 (screening).
* Physician-diagnosed peanut allergy and following a strict peanut-free diet
* Peanut-specific IgE \> 0.7 kUA/L.
* A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening).
* An ED ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (DBPCFC).
Key Exclusion Criteria:
* Peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut.
* Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region).
* Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy).
* History of any immunotherapy for peanut allergy, including Epicutaneous immunotherapy (EPIT), oral immunotherapy (OIT), sublingual immunotherapy (SLIT).
* Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
* Uncontrolled persistent asthma. COMBINATION_PRODUCT: DBV712 250 mcg, COMBINATION_PRODUCT: Placebo
Allergy, Peanut Allergy
Peanut hypersensitivity, Epicutaneous Immunotherapy (EPIT), Epicutaneous, Immunotherapy, Viaskin, Nut and Peanut Hypersensitivity, Food Hypersensitivity, Peanut Allergy, Food Allergy, Nut and Peanut Allergy, Safety Study
ASPEN-09: A Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies (ASPEN-09)
The purpose of this study is to evaluate evorpacept with anti-cancer therapies in advanced/metastatic malignancies. The study is comprised of the following substudies: * Metastatic HER2+ breast cancer (MBC) - single-arm substudy evaluating the efficacy, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan. This substudy is actively recruiting. * Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not recruiting. * Recurrent/metastatic head and neck cancer (HNSCC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not recruiting.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Heather McArthur
ALL
18 Years to old
PHASE1
NCT07007559
STU20251383
Inclusion Criteria (all substudies):
* Participants must have at least one measurable lesion as defined by RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 to 1.
* Life expectancy of at least 3 months
* Participants must have recovered from all AEs due to previous therapies, procedures, and surgeries to baseline severity or ≤Grade 1 per NCI CTCAE v5.0 except for AEs not deemed reversible which do not constitute a safety risk by Investigator judgment
MBC substudy:
* Histologically confirmed invasive HER2 positive breast cancer
* Available tumor tissue (FFPE slides or block). A fresh biopsy is preferred but optional.
* Received at least one prior line of therapy including T-DXd for locally advanced/metastatic HER2 positive breast cancer. Prior neoadjuvant therapy which resulted in relapse within 6 months of completion of T-DXd will be considered a line of treatment for metastatic disease.
* Progressed on or following the most recent line of therapy
* Eligible to receive one of the following chemotherapy options (capecitabine, eribulin, gemcitabine, paclitaxel or vinorelbine)
* LVEF ≥50%
* Adequate renal function (estimated creatinine clearance ≥30 mL/min as calculated using the Cockroft-Gault equation
* Adequate liver function:
* Total bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if the participant has documented Gilbert syndrome);
* Aspartate and alanine transaminase (AST and ALT) ≤3 x ULN (≤5.0 x ULN if liver involved by metastatic disease).
Exclusion Criteria (all substudies):
* Participants with known CNS metastases unless treated and stable prior to enrollment
* Following anti-cancer therapy with insufficient washout before C1D1:
• chemotherapy, hormonal therapy, radiation therapy or small molecule anti-cancer therapy within 14 days or 5 half-lives (whichever is shorter) of C1D1.
• Immune therapy or other biologic therapy (e.g., monoclonal antibodies, antibody-drug conjugates) for the treatment of cancer for: 28 days or 5 half-lives (whichever is shorter) of C1D1) * Prior exposure to any anti-CD47 or anti-SIRPα agent. * History of autoimmune hemolytic anemia, autoimmune thrombocytopenia, or hemolytic transfusion reaction. * Had an allogeneic tissue/solid organ transplant. * Any active, unstable cardiovascular disease * Intolerance to or who have had a severe allergic or anaphylactic reaction to antibodies or infused therapeutic proteins or participants who have had a severe allergic or anaphylactic reaction to any of the substances included in the study drug (including excipients). * Has an active autoimmune disease that has required systemic treatment in past 2 years MBC substudy: * Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency or significant toxicity with prior flurouracil (5FU) based regimen * Other primary malignancy within 2 years * Any condition that would be contraindicated to receiving trastuzumab
• chemotherapy, hormonal therapy, radiation therapy or small molecule anti-cancer therapy within 14 days or 5 half-lives (whichever is shorter) of C1D1.
• Immune therapy or other biologic therapy (e.g., monoclonal antibodies, antibody-drug conjugates) for the treatment of cancer for: 28 days or 5 half-lives (whichever is shorter) of C1D1) * Prior exposure to any anti-CD47 or anti-SIRPα agent. * History of autoimmune hemolytic anemia, autoimmune thrombocytopenia, or hemolytic transfusion reaction. * Had an allogeneic tissue/solid organ transplant. * Any active, unstable cardiovascular disease * Intolerance to or who have had a severe allergic or anaphylactic reaction to antibodies or infused therapeutic proteins or participants who have had a severe allergic or anaphylactic reaction to any of the substances included in the study drug (including excipients). * Has an active autoimmune disease that has required systemic treatment in past 2 years MBC substudy: * Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency or significant toxicity with prior flurouracil (5FU) based regimen * Other primary malignancy within 2 years * Any condition that would be contraindicated to receiving trastuzumab
DRUG: Evorpacept (ALX148), DRUG: Trastuzumab, DRUG: Paclitaxel, DRUG: Capecitabine, DRUG: Eribulin, DRUG: Gemcitabine, DRUG: Vinorelbine
Breast Cancer, Metastatic, Breast - Female, Breast - Male
metastatic, Her2+, metastatic HER2-positive breast cancer, breast cancer, HER2-positive, Evorpacept, CD47, ERBB2, Enhertu, trastuzumab deruxtecan, ASPEN-09, Herceptin, solid tumors, trastuzumab, ALX148, mBC, ASPEN-Breast
UT Southwestern
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer (ReDiscover-2)
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment with a CDK4/6 inhibitor.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Nisha Unni
ALL
18 Years to old
PHASE3
NCT06982521
STU20251176
Inclusion Criteria:
* Patient has ECOG performance status of 0-1
* One or more known primary oncogenic PIK3CA mutation(s)
* Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with a gonadotropin-releasing hormone (GnRH) agonist. Patients are to have commenced treatment with a GnRH agonist at least 4 weeks prior to randomization and must be willing to continue on it for the duration of the study.
* Histologically or cytologically confirmed diagnosis of HR+/HER2- locally advanced or metastatic breast cancer (ABC) with radiological or objective evidence of recurrence or progression; locally advanced disease must not be amenable to resection with curative intent
* Measurable disease per RECIST v1.1 or evaluable bone-only disease.
* Must have radiological evidence of progression on or after previous treatment for HR+/HER2- ABC with:
• At least 1 and no more than 2 lines of endocrine therapy (ET) in the (neo)adjuvant setting with recurrence on or within 12 months of completion or in the ABC setting
• 1 prior line of CDK4/6 inhibitor therapy in one of the following settings:
• CDK4/6 inhibitor + ET in the ABC setting
• CDK4/6 inhibitor therapy in the adjuvant setting if progression occurred during or within 12 months of completion of adjuvant CDK4/6 inhibitor with ET
• Patients who progressed during or within 12 months of completion of adjuvant CDK4/6 inhibitor and after receiving CDK4/6 inhibitor therapy in the advanced setting are considered to have had \>1 prior line of CDK4/6 inhibitor and are not eligible
Exclusion Criteria:
* Prior treatment with any of the following:
• CDK2 or selective CDK4 inhibitors or any investigational therapies targeting cyclin dependent kinases
• PIK3, AKT, or mTOR inhibitors or any agent whose mechanism of action is the inhibit the PIK3/AKT/mTOR pathway
• Immunotherapy
• Antibody drug conjugates * Type 1 diabetes, or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥ 140 mg/dL, or glycosylated hemoglobin (HbA1c) ≥7.0% (≥ 53 mmol/mol). * Clinically significant, uncontrolled cardiovascular disease * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events * Known active uncontrolled or symptomatic CNS metastases associated with progressive neurological symptoms or requiring ongoing corticosteroids or anticonvulsants for symptomatic control * Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease * History of hypersensitivity to fulvestrant or drugs in a similar class as fulvestrant, RLY-2608, or capivasertib, including their excipients * Known activating AKT mutations, loss-of-function PTEN mutations, or loss of PTEN expression resulting in oncogenic pathway activation downstream of PI3K
DRUG: RLY-2608, DRUG: Capivasertib, DRUG: Fulvestrant
PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Breast - Female, Breast - Male
UT Southwestern
Recovery Through Inspiration, Support, and Empowerment (RISE)
The goal of this pilot study is to test the effectiveness of a novel intervention for young adults (ages 18-27) with mental health conditions who have been released from an acute care psychiatric facility. The intervention aims to reduce suicidality, depression, anxiety, re-hospitalization, and improve mental health recovery by using outpatient services. The current standard of care (SOC) for these patients at discharge includes a discharge plan with a list of their medications, anticipated outpatient appointments, and information on when and where to find community resources. The intervention being tested involves the implementation of a mental health recovery education and support program, involving one-on-one and small group meetings led by Peer Support Specialists (PSS) and Recovery Community Organizations (RCO). Participants will be assigned to either Cohort A or B for 8 weeks. Cohort A will be the intervention group with PSS and RCOs. * Weeks 1-4: One-on-one meetings with PSS for education and support. Assessments will be completed at weeks 2 and 4. * Weeks 5 and 7: One-on-one meetings with PSS for education and support. * Week 6 and 8: Group meetings with PSS and other participants from RCOs. Assessments will be completed during these weeks. Cohort B will be the SOC group with no PSS or RCOs. * Weeks 1-4: Weekly check in phone calls with a member of the research team. Assessments will be completed at weeks 2 and 4. * Weeks 5-8: Check in phone calls with a member of the research team every other week. Assessments will be completed at weeks 6 and 8. Data collected from participant assessments, adherence to medication, and re-admittance to a psychiatric facility will be used to compare the intervention to the SOC.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Cameron.Pham@UTSouthwestern.edu
Joseph Guillory
ALL
18 Years to 27 Years old
NA
NCT07051200
STU-2024-0135
Inclusion Criteria:
* Chief complaint of suicidal ideation, suicide attempt, depression, and/or anxiety
* discharged from inpatient care or from emergency department
* men and women ages 18-27
Exclusion Criteria:
* primary diagnosis of: substance use disorder, schizophrenia spectrum, intellectual development disorder, autism spectrum disorder (level II or III) BEHAVIORAL: Peer Support Services Recovery
Suicidal Ideation, Suicide Attempt, Anxiety, Depression Disorders
Peer Support Specialist (PSS), Recovery Community Organization (RCO), Mental Health Recovery, Transitional Age Youth (TAY), UT Southwestern Medical Center, Young Adult
UT Southwestern
A Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular Atrophy (OPAL)
This double-blind, Phase 2, multiple-dose study will be conducted to evaluate the PK/PD, efficacy, safety, and tolerability of apitegromab in subjects \<2 years old with 5q autosomal recessive SMA who have delayed motor milestones for their age attributed to SMA at the discretion of the Investigator or a Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) score \<55.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Samantha.bridges@UTSouthwestern.edu
Kaitlin Batley
ALL
to 2 Years old
PHASE2
NCT07047144
STU20250609
Inclusion Criteria:
• Is \<2 years old at the time of the informed consent
• Had a gestational age of ≥35 weeks and gestational body weight ≥2.0 kg at birth
• Has confirmed diagnosis of 5q autosomal recessive SMA
• Has confirmed presence of SMN2 gene copy(ies)
• Must have been treated with an approved SMN1-targeted therapy (ie, onasemnogene abeparvovec-xioi) or are continuing to be treated with an approved SMN2-targeted therapy (ie, nusinersen or risdiplam)
• Body weight for age is no less than 1st percentile based on the WHO Child Growth Standards at the Screening Visit
• Has delayed motor milestones for age attributed to SMA at the discretion of the Investigator or a CHOP-INTEND score \<55
Exclusion Criteria:
• Nutritional status that is not anticipated to be stable throughout the study or medical necessity for a gastric feeding tube, where most feeds are administered by this route
• Major orthopedic issues such as severe scoliosis or severe contractures or interventional procedure, including spine or hip surgery, which is considered to have the potential to substantially limit the ability of the subject to be evaluated on any motor function outcome measures, within 6 months before Screening or anticipated during the study
• Any other physical limitations (eg, the subject requires cast for contractures) that would prevent the subject from undergoing motor function outcome measures throughout the study.
DRUG: Apitegromab, DRUG: Nusinersen, DRUG: Risdiplam
Spinal Muscular Atrophy, SMA, Spinal Muscular Atrophy Type 2, Spinal Muscular Atrophy Type 3, Neuromuscular Manifestations, Anti-myostatin
Children’s Health
This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.
This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Tian Zhang
MALE
18 Years to old
PHASE3
NCT07028853
STU20250848
Inclusion Criteria
* Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening.
* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
* Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue/visceral disease).
* Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement).
* Participants must have ECOG PS 0 or 1.
Exclusion Criteria
* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Clinically significant cardiovascular disease.
* Known or suspected brain metastasis or active leptomeningeal disease.
* Participants must be treatment naïve at the mCSPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents is allowed for mCSPC.
* Previous administration with an investigational product (drug or vaccine) within 30 days.
* Use of 5-alpha reductase inhibitors is prohibited within 28 days of randomization.
* Prior surgery from which the participant has not fully recovered at least 28 days prior to randomization
* Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitors and inducers (with exception of enzalutamide as part of this study).
* Inadequate organ function.
DRUG: Mevrometostat, DRUG: Placebo, DRUG: Enzalutamide
Metastatic Castration Sensitive Prostate Cancer (mCSPC), Hormone Sensitive Prostate Cancer, Prostate Cancer, Cancer of the Prostate, Prostate
Hormone Sensitive Prostate Cancer, Mevrometostat, Metastatic castration sensitive prostate cancer, PF-06821497, EZH2, enhancer of zeste homologue-2, enzalutamide, mCSPC, HSPC, Prostate cancer, castrate sensitive prostate cancer, prostatecancer-study.com, Phase 3, efficacy, safety, pharmacokinetics, pharmacodynamics
UT Southwestern
A Trial of D-mannose for the Prophylaxis of Recurrent Urinary Tract Infections (DmannoseRCT)
A randomized, double-blind, placebo-controlled, 12-month study to determine the effectiveness of D-mannose (2g daily) supplementation in rUTI (recurrent urinary tract infection) prevention in post-menopausal women.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Jessica.DeAraujoPaula@UTSouthwestern.edu
Philippe Zimmern
FEMALE
55 Years to 85 Years old
NA
NCT06940622
STU-2024-1090
Inclusion Criteria:
* Female, post-menopausal, age ≥ 55 years old
* Diagnosis of recurrent UTI, defined as ≥ 3 symptomatic culture-proven UTI episodes in 12 months or ≥ 2 in 6 months.
* Currently free from a UTI determined based on absence of symptoms as determined by the UTI symptom assessment questionnaire79 and negative urine culture (\<103 colony forming units per ml of urine).
* Able to attend all follow-up appointments for the study.
* A negative upper and lower urinary tract evaluation, including pelvic examination for pelvic organ prolapse (less than stage 2), measurement of post-void residual (less than 50 ml), and imaging (renal ultrasound and standing voiding cystourethrogram) to exclude kidney stone, hydronephrosis, reflux, or urethral diverticulum.
Exclusion Criteria:
* Current use of D-mannose. Patients willing to stop taking D-mannose will be offered to join the trial after a 4-week wash-out period.
* Complicated UTIs, including need for catheter drainage or intermittent catheterization, neurogenic bladder, bladder augmentation, or urinary diversion.
* Ongoing supplement use (Box 1). Patients willing to stop taking the listed supplements will be offered to join the trial after a 4-week wash-out period.
* Evidence of upper tract infection (pyelonephritis), including temperature higher than 38°C, flank/lumbar pain or tenderness
* Diagnosis of interstitial cystitis or overactive bladder syndrome
* Prophylactic antibiotics started in the last 3 months and unwilling to discontinue, or intention to start in the next 12 months
* Use of Uromune or other vaccine approaches to reduce rUTI
* Participation in a research study involving an investigational product in the past 12 weeks
* Receipt of phage treatment
* History of chronic diarrhea requiring regular therapy
* Inability to swallow or known history of gastrointestinal malabsorption
* History of recurrent vaginal yeast infections
* Systemic disease precluding enrollment in this study (uncontrolled diabetes with HgA1C above 7, ongoing chemotherapy or immunotherapy, renal insufficiency \[creatinine \> 1.5 g/dl\]), mental or cognitive impairment, weight loss diet requiring excessively large amounts of fluid intake, or other health-related specific diet).
* Nursing home resident
* BMI \>40
Box 1 Supplements to avoid
* Multi-Vitamins and Multi-Mineral capsules
* Specific Vitamins or Minerals (e.g., Calcium, Citrical, Calcium Gummies, Vitamin A, D, Niacin, Pyridoxine, Selenium, Vitamin E, B6, Iron, Omega 3, D3, Magnesium, B-Complex, Women's Ultra MultiVitamin, GNC B-Complex, B-12, PreserVision Areds2, Vitamins D, B Pollen)
* Probiotics
* Cranberry Mannose or Cranberry Extract Weight loss products to avoid
* Medifast
* Vitafusion
* OptiVin Products
* Appetite Suppressants
* Keto-Fuel DIETARY_SUPPLEMENT: D-Mannose, DIETARY_SUPPLEMENT: Placebo
Recurrent UTIs, Recurrent Urinary Tract Infections, Recurrent Urinary Tract Infections in Women, Recurrent Urinary Tract Infection, Cystitis Recurrent, Cystitis Chronic, UTI, UTI - Urinary Tract Infection, UTI - Lower Urinary Tract Infection
D-mannose, dmannose, uti, ruti, recurrent urinary tract infection, urinary tract infection, cystitis, chronic uti, chronic cystitis
UT Southwestern
A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)
Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Tian Zhang
MALE
18 Years to old
PHASE3
NCT06925737
STU20250466
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
* Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening
* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography (CT)/magnetic resonance imaging (MRI)
* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment
* Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy
* Has recovered from adverse events (AEs) due to previous anticancer therapies
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Is unable to swallow tablets/capsules
* Has any of the following indicators of interstitial lung disease (ILD)/pneumonitis:
• Has any history of ILD/pneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids
• Has current ILD/pneumonitis
• Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses * Has uncontrolled or significant cardiovascular disease * Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC) * Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities * Has a "superscan" bone scan
DRUG: Ifinatamab deruxtecan, DRUG: Docetaxel, DRUG: Prednisone, DRUG: Rescue Medication
Prostate Cancer, Prostatic Neoplasms, Prostate
UT Southwestern; Parkland Health & Hospital System
UTSW NORC Pilot Spinal Cord Injury Dietary Program
The goal of this observational study is to learn about the effects of a 9-week dietician-guided program modified from the National Diabetic Prevention Program (modified DPP-diet) in people with spinal cord injury on body composition and insulin sensitivity. The main question it aims to answer is: Does 9 week modified DPP-diet reduce body fat percentage and insulin resistance? Participants will: Have 9 weeks of Telehealth visit with dietician certified in providing DPP. Visit the laboratory before, immediately and 9 weeks after completion of the modified DPP-diet. Share with the researcher on the perceived benefit and obstacles in implementing the modified DPP-diet as part of their daily activities.
Call 214-648-5005
studyfinder@utsouthwestern.edu, Yi-Ting.Tzen@UTSouthwestern.edu
Yi-Ting Tzen
ALL
18 Years to 65 Years old
NA
NCT06924177
STU20250145
Inclusion Criteria:
* age 18-65 years old
* have had SCI for more than one year
* not independently ambulatory
* primarily uses a wheelchair for mobility
* community-dwelling
* without comorbidities listed in the exclusion criteria
Exclusion Criteria:
* uncontrolled type 2 diabetes mellitus
* pregnancy
* active systemic disease, e.g., heart disease, real failure/insufficiency, multiple myeloma, lupus with nephropathy, sickle cell disease, symptomatic myasthenia gravis, poorly controlled hypo- or hyperthyroidism. OTHER: Telehealth with dietician
Obesity and Obesity-related Medical Conditions, Spinal Cord Injury, Chronic
spinal cord injuries, obesity, insulin resistance
UT Southwestern