Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
Preventing Metabolic Side Effects of Thiazide Diuretics With KMgCitrate
Chlorthalidone (CTD) may produce various metabolic disturbances, including hypokalemia,
activation of Renin-Angiotensin- Aldosterone (RAA) system, oxidative stress, dyslipidemia,
Fibroblast growth factor 23 (FGF23) synthesis, and magnesium depletion. These factors may
interact with each other to contribute to the development of insulin resistances and
metabolic syndrome. Smaller studies have suggested that Potassium magnesium Citrate (KMgCit)
can ameliorate CTD- induced metabolic side effects independent of correction of hypokalemia.
This study will tests if KMgCit ameliorates CTD induced metabolic effects independent of
correction of hypokalemia.
Call 214-648-5940 danielle.pittman@utsouthwestern.edu or Call 214-648-5005 studyfinder@utsouthwestern.edu, Ashley.Murillo@UTSouthwestern.edu
Wanpen Vongpatanasin
17620
All
21 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02665117
STU 092015-058
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Inclusion Criteria:
• Treated or untreated stage I hypertension
Exclusion Criteria:
• Diabetes mellitus,
• Renal impairment (serum creatinine > 1.4 mg/dL),
• Any heart diseases such as congestive heart failure, sustained arrhythmia, or coronary
heart disease,
• Chronic regular NSAID use,
• Allergy to thiazide diuretics,
• Gastro-esophageal reflux disease (GERD) requiring treatment with acid reducing agents
or antacid more than once a week,
• Esophageal-gastric ulcer or history of gastrointestinal bleeding,
• Chronic diarrhea, vomiting,
• Excessive sweating,
• Unprovoked hypokalemia (serum K < 3.5 mmol/L) or hyperkalemia (serum K > 5.3 mmol/L),
• Abnormal liver function test (Aspartate transaminase (AST) or Alanine transaminase
(ALT) above upper limit of normal range),
• Subjects on any potassium supplement on a regular basis for any reason, such as
patients with primary aldosteronism,
• Pregnancy,
• History of major depression, bipolar disorder, or schizophrenia,
• History of substance abuse,
• Gout,
• Metabolic alkalosis, with serum bicarbonate > 32 meq/L,
• Severe dietary salt restriction, less than1/2 spoonful or 50 meq sodium/day.
• Patient with Claustrophobia will not have MRI but can still participate in the study
without MRI
• Metal implants will not have MRI but can still participate in the study without MRI
A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of
ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or
PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.
1. At least 18 years of age.
2. Evidence of a personally signed and dated informed consent form indicating that the
subject has been informed of all pertinent aspects of the study prior to initiation of
any study-related procedures.
3. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures
4. Primary diagnosis of symptomatic PAH.
5. Has had a right heart catheterization (RHC) performed at or within 3 years prior to
Screening (RHC will be performed during Screening if not available) that is consistent
with the diagnosis of PAH.
6. Has WHO/ NYHA functional class II to IV symptoms.
7. If on PAH-specific background oral therapy, subject is on stable therapy with either
an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 inhibitor
(PDE5-I) or a soluble guanylate cyclase (sGC) stimulator. Subjects may be naïve to
PAH-specific treatment.
8. Has a 6MWD of ≥150 meters.
9. If taking concomitant medications that may affect the clinical manifestations of PAH
(eg, calcium channel blockers, diuretics, digoxin, or L arginine supplementation, beta
blockers, angiotensin-converting enzyme inhibitors, or angiotensin II receptor
blockers), must be on a stable dose for at least 30 days prior to the Baseline Visit
and the dosage maintained throughout the study. The exception is that the dose of
diuretics must be stable for at least the 10 days prior to Baseline.
10. Both male and female subjects agree to use a highly effective method of birth control
throughout the entire study period from informed consent through to the 30-Day
Follow-up Visit, if the possibility of conception exists. Eligible male and female
subjects must also agree not to participate in a conception process during the study
and for 30 days after the last dose of IMP. Eligible male subjects must agree not to
participate in sperm donation for 90 days after the last dose of IMP.
Exclusion Criteria:
1. For subjects with known HIV-associated PAH, a cluster designation 4 (CD4+) T-cell
count <200/mm3 within 90 days of Baseline.
2. Must not have 3 or more left ventricular dysfunction risk factors as defined in the
study protocol.
3. Has evidence of more than mild lung disease on pulmonary function tests performed
within 180 days prior to, or during Screening.
4. Has evidence of thromboembolic disease as determined by a V/Q lung scan or local
standard of care diagnostic evaluation at or after diagnosis of PAH.
5. Current diagnosis of ongoing and clinically significant sleep apnea as defined by the
Investigator.
6. Male subjects with a corrected QT interval using Fridericia's formula (QTcF) >450 msec
and female subjects with a QTcF >470 msec on ECG recorded at Screening and analyzed by
the central ECG laboratory. Subjects with evidence of intraventricular conduction
delay, defined as a QRS interval greater than 110 msec, will be excluded if the QTcF
is >500 msec for both males and females.
7. Severe chronic liver disease (ie, Child-Pugh Class C), portal hypertension, cirrhosis
or complications of cirrhosis/portal hypertension (eg, history of variceal hemorrhage,
encephalopathy).
8. Confirmed active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
9. Subjects with alanine aminotransferase or aspartate aminotransferase ≥3 times the
upper limit of normal (ULN) or total bilirubin ≥2 × ULN at Screening.
10. Chronic renal insufficiency as defined by serum creatinine >2.5 mg/dL or requiring
dialysis at Screening.
11. Hemoglobin concentration <9 g/dL at Screening.
12. Subjects treated with an IV or SC prostacyclin pathway agent (eg, epoprostenol,
treprostinil, or iloprost) for PAH at any time prior to Baseline (use in vasoreactive
testing is permitted).
13. Subjects currently on or who were treated with an inhaled or oral prostacyclin pathway
agent (iloprost, treprostinil, beraprost, or selexipag) within 90 days prior to
Baseline.
14. Subject has pulmonary veno-occlusive disease.
15. Malignancy diagnosed and/or treated within 5 years prior to Screening, with the
exception of localized non-metastatic basal cell or squamous cell carcinoma of the
skin or in-situ carcinoma of the cervix excised with curative intent.
16. Subject tests positive for amphetamine, cocaine, methamphetamine,
methylenedioxymethamphetamine or phencyclidine in urine drug screen performed at
Screening, or has a recent history (6 months) of alcohol or drug abuse. A subject will
not be excluded due to a positive drug screen caused by prescribed medications.
17. Initiation or discontinuation of a cardio-pulmonary rehabilitation program based upon
exercise within 90 days prior to Screening and/or planned during study participation.
18. Prior participation in any study of ralinepag or participation in another
interventional clinical study with medicinal products within 30 days prior to
Screening. Concurrent participation in registry or observational studies is allowed,
as long as the subject can fulfill all other entry criteria and comply with all study
procedures.
19. Any reason that, in the opinion of the Investigator or Medical Monitor, precludes the
subject from participating in the study (eg, any previous or intercurrent medical
condition) that may increase the risk associated with study participation or that
would confound study analysis or impair study participation or cooperation.
20. Known hypersensitivity to ralinepag or any of the excipients.
21. Life expectancy <12 months based on the Investigator's opinion.
22. Women who are pregnant, lactating or breast-feeding.
Prostacyclin, Connective Tissue Disease-Associated, 6 Minute Walk Test, 6 Minute Walk Distance, Pulmonary Vascular Resistance, Right Ventricular Function
Preventing Cognitive Decline by Reducing BP Target Trial (PCOT)
The PCOT study is a multi-site randomized trial of patients 70 years or older with high BP.
The main goal of the study Preventing Cognitive Decline by Reducing BP Target Trial (PCOT) is
to conduct a large pragmatic clinical trial (PCT) to test the hypothesis that patients who
receive care with a combination of clinical decision support (CDS) and team-based care
delivered in primary care practices will have better blood pressure control and a lower
incidence of mild cognitive impairment and dementia than patients receiving usual medical
care. Patients will be recruited from UT Southwestern Medical Center and Parkland Health &
Hospital System.
• High BP defined as at least 2 BP readings of SBP >= 130 or DBP >=80 during the 24
months prior to enrollment
• Clinic visit with primary care provider within the last 24 months
• Ability to write and speak English or Spanish
• 70 years of age or older 5 •Ability to understand and willingness to provide informed
consent
• Owns a smartphone or tablet
Exclusion Criteria:
• Blood pressure consistently <130/80 mmHg
• Presence of dementia, Alzheimer's disease, or significant neurological disease
• Major and unstable heart disease (e.g., acute heart failure (systolic or diastolic),
acute on chronic heart failure (systolic or diastolic), acute coronary syndrome or
cardiac arrest, liver or renal transplantation
• Under 70 years of age
• Inability to write or speak English or Spanish
• Chronic kidney disease stage 5 or ESKD
• Chemotherapy
• Any conditions judged by the medical providers to contraindicate participation due to
risk to patient safety or lack of adherence
• Expected life expectancy under a year
Other: Clinical Support Decision Tool
Hypertension, Blood Pressure, Cognitive Decline
UT Southwestern; Parkland Health & Hospital System
Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer
This randomized phase III trial studies digital tomosynthesis mammography and digital
mammography in screening patients for breast cancer. Screening for breast cancer with
tomosynthesis mammography may be superior to digital mammography for breast cancer screening
and may help reduce the need for additional imaging or treatment.
• Women of childbearing potential must not be known to be pregnant or lactating
• Patients must be scheduled for, or have intent to schedule, a screening mammogram
• Patients must be able to tolerate digital breast tomosynthesis and full-field digital
mammographic imaging required by protocol.
• Patients must be willing and able to provide a written informed consent
• Patients must not have symptoms or signs of benign or malignant breast disease (eg,
nipple discharge, breast lump) warranting a diagnostic rather than a screening
mammogram, and/or other imaging studies (eg, sonogram); patients with breast pain are
eligible as long as other criteria are met
• Patients must not have had a screening mammogram within the last 11 months prior to
date of randomization
• Patients must not have previous personal history of breast cancer including ductal
carcinoma in situ
• Patients must not have breast enhancements (e.g., implants or injections)
• ANNUAL SCREENING REGIMEN ELIGIBILITY CHECK
• To be eligible for inclusion in the annual screening regimen one of the following
three conditions must be met in addition to the eligibility criteria above:
• Patients are pre-menopausal; OR
• Post-menopausal aged 45-69 with any of the following three risks factors:
• Dense breasts (BIRADS density categories c-heterogeneously dense or
d-extremely dense), or
• Family history of breast cancer (first degree relative with breast cancer),
or, positive genetic testing for any deleterious genes that indicate an
increased risk for breast cancer, or
• Currently on hormone therapy; OR
• Post-menopausal ages 70-74 with either of the following two risk factors:
• Dense breasts (BIRADS density categories c-heterogeneously dense or
d-extremely dense), or
• Currently on hormone therapy
• Postmenopausal women are defined as those with their last menstrual period more than
12 months prior to study entry; for the purpose of defining menopausal status for
women who have had surgical cessation of their periods, women who no longer have
menses due to hysterectomy and oophorectomy will be considered postmenopausal; women
who no longer have menses due to hysterectomy without oophorectomy will be considered
premenopausal until age 52 and postmenopausal thereafter
• All other postmenopausal women are eligible for inclusion in the biennial screening
regimen
• For those women who cannot be assigned to annual or biennial screening at the time of
study entry and randomization because they are postmenopausal, have no family history
or known deleterious breast cancer mutation, are not on hormone therapy AND have not
had a prior mammogram, breast density will be determined by the radiologist?s
recording of it at the time of interpretation of the first study screening
examination, either DM or TM; for those who are randomized to TM, radiologists will
assign BI-RADS density through review of the DM or synthetic DM portion of the TM
examination; such women cannot be part of the planned stratification by screening
frequency and are expected to represent far less than 1% of the Tomosynthesis
Mammographic Imaging Screening Trial (TMIST) population
• Breast density will be determined by prior mammography reports, when available; all
other risk factors used to determine patient eligibility for annual or biennial
screening will be determined by subject self-report
Procedure: Digital Mammography, Procedure: Digital Tomosynthesis Mammography, Other: Laboratory Biomarker Analysis
Breast Screening, Breast - Female
Digital Mammography, Breast Tomography, Screening Mammography, TMIST
Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (SELECT)
The researchers are doing the study to see if semaglutide may reduce the risk of having
cardiovascular events in patients with overweight or obesity and with prior cardiovascular
disease. The participant will either get semaglutide (active medicine) or placebo ("dummy"
medicine). Which treatment the participants get is decided by chance. The participant's
chance of getting semaglutide or placebo is the same. The participant will get the study
medicine in a pen. The participants will need to use the pen to inject the study medicine in
a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have
up to 25 clinic visits with the study doctor.
•Male or female, age greater than or equal to 45 years at the time of
signing informed consent •Body mass index (BMI) greater than or equal to 27 kg/m^2 •Have
established cardiovascular (CV) disease as evidenced by at least one of the following:
prior myocardial infarction; prior stroke (ischemic or haemorrhagic stroke); or symptomatic
peripheral arterial disease (PAD), as evidenced by intermittent claudication with
ankle-brachial index (ABI) less than 0.85 (at rest), or peripheral arterial
revascularization procedure, or amputation due to atherosclerotic disease Exclusion
Criteria: •Any of the following: myocardial infarction, stroke, hospitalisation for
unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the
day of screening •HbA1c greater than or equal to 48 mmol/mol (6.5 %) as measured by the
central laboratory at screening •History of type 1 or type 2 diabetes (history of
gestational diabetes is allowed)
Drug: Semaglutide, Drug: Placebo (semaglutide)
Obesity, Overweight
UT Southwestern; Parkland Health & Hospital System
The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure
controlled trial, comparing renal denervation performed with the Peregrine System Kit in the
treatment group to the sham control group (without renal denervation - no alcohol infusion).
Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central
randomization.
1. Has 3 office blood pressure measurements with a mean office systolic blood pressure
(SBP) of ≥150 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of
≥90 mmHg when receiving 2 to 5 antihypertensive medications.
2. Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings
Exclusion Criteria:
1. Subject has renal artery anatomy abnormalities.
2. Subject has an estimated glomerular filtration rate (eGFR) of ≤45 mL/min/1.73 m2,
based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; or
is on chronic renal replacement therapy.
3. Subject has documented sleep apnea.
4. Subject has any of the following conditions: severe cardiac valve stenosis, heart
failure (New York Heart Association [NYHA] Class III or IV), chronic atrial
fibrillation, and known primary pulmonary hypertension (>60 mmHg pulmonary artery or
right ventricular systolic pressure).
5. Subject is pregnant or lactating at the time of enrollment or planning to become
pregnant during the trial time period (female subjects only).
6. Subject is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive
medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal
pulmonary inhalants are allowed.
7. Subject has a history of myocardial infarction, unstable angina pectoris, or
stroke/TIA within 6 months prior to the planned procedure.
Drug: Dehydrated alcohol, Device: Peregrine System Kit (Sham Procedure)
Hypertension
Renal Denervation, Alcohol
UT Southwestern; Parkland Health & Hospital System
Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity (STEP-HFpEF)
This study will look at how the participants daily life is affected by their heart failure.
The study will also look at the change in participants body weight from the start to the end
of the study.
This is to compare the effect on heart failure symptoms and on body weight in people taking
semaglutide (a new medicine) to people taking "dummy" medicine.
Participants will either get semaglutide or "dummy" medicine - which treatment participants
get is decided by chance.
Participants will need to take 1 injection once a week. The study medicine is injected with a
thin needle in a skin fold in the stomach area, thigh or upper arm.
During the study participants will have talks with the study staff about healthy lifestyle
choices including healthy food and physical activity.
The study will last for approximately 59 weeks. Participants will have 11 clinic visits and 1
phone call with the study doctor. Women: Women cannot take part if they are pregnant,
breast-feeding or plan to become pregnant during the study period.
• Male or female, age above or equal to 18 years at the time of signing informed
consent.
• Body mass index (BMI) greater than or equal to 30.0 kg/m^2
• New York Heart Association (NYHA) Class II-IV
• Left ventricular ejection fraction (LVEF) greater than or equal to 45 percentage at
screening
Exclusion Criteria:
• A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before
screening irrespective of medical records
• Haemoglobin A1c (HbA1c) greater than or equal to 6.5 percentage (48 mmol/mol) based on
latest available value from medical records, no older than 3 months or if unavailable
a local measurement at screening
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight (REDEFINE 1)
This study has 2 parts: First part is the main study and second part is the extension study.
During the main study participants will receive 1 of 4 study medicines. If participants
continue in the extension study, they will not receive any study medicine during the
extension. The main study will look at how well CagriSema helps participants with excess body
weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and
semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy"
medicine. Which treatment participants get is decided by chance. They will take one injection
once a week. The study medicine is injected briefly with a thin needle, typically in the
stomach, thighs or upper arms.
Extension study: After the main study, not all participants will continue in the extension
study. The study staff will tell the participant if they will continue or not into the
extension study. In the extension study we will look at what happens to the participant's
body weight and diseases related to excess body weight after the participant stops taking the
study medicine. The main study will last for about 1½ years and the extension study will last
for another 2 years.
• Male or female
• Age above or equal to 18 years at the time of signing informed consent
• Body mass index (BMI) greater than or equal to 30.0 kilograms per square meter
(kg/m^2) or b) BMI greater than or equal to 27.0 kg/m^2 with the presence of at least
one weight-related comorbidity including, but not limited to hypertension,
dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
Exclusion Criteria:
•Glycaemia related: a) Glycated Haemoglobin (HbA1c) greater than or equal to 6.5 percent
(48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening b)
History of type 1 or type 2 diabetes mellitus
Exploring the Effects of Corticosteroids on the Human Hippocampus
Chronic corticosteroid (CS) exposure is associated with changes in memory and the hippocampus
in both humans and in animal models. The hippocampus has a high concentration of
glucocorticoid receptors (GCRs), and the pre-clinical literature demonstrates shortening of
apical dendrites in the CA3 region of the hippocampus and decreased neurogenesis in the
dentate gyrus (DG) following CS administration. In humans, both stress and CS exposure are
associated with a decline in declarative memory performance (a process mediated by the
hippocampus). Impairment in declarative memory and hippocampal atrophy are reported in
patients with excessive CS release due to Cushing's disease, and, by our group, in patients
receiving prescription CS therapy. These findings have important implications for patients
with mood disorders, as a large subset of people with major depressive disorder (MDD) show
evidence of HPA axis activation, elevated cortisol and, importantly, resistance to the
effects of CSs on both the HPA axis and on declarative memory. Thus, resistance to
corticosteroids appears to be a consequence of MDD.
this study will examine changes in declarative memory, as well as use state-of-the-art
high-resolution multimodal neuroimaging, including structural and functional (i.e.,
task-based and resting state) MRI, in both men and women healthy controls, and, as an
exploratory aim, a depressed group, given 3-day exposures to hydrocortisone (160 mg/day) or
placebo. The study will translate preclinical findings to humans, provide valuable data on
possible sex differences in the response to cortisol and, for the first time, identify
specific hippocampal subfields (e.g., CA3/DG) in humans that are most sensitive to acute CS
effects. Using resting state fMRI data and whole brain connectomics using graph theoretical
approaches, we will determine the effects of cortisol exposure on functional brain networks.
Furthermore, this will be the first study to use neuroimaging to compare the brain's response
to CSs in people with depression vs. controls, and determine whether depressed people
demonstrate glucocorticoid resistance within the hippocampus. We hypothesize that hippocampal
response to acute CSs will be greatest in the CA3/DG subfield, greater in women than in men,
and that depressed people will show a blunted hippocampal response to CSs compared to
controls. A multidisciplinary research team with extensive experience in CS effects on the
brain and hippocampal subfield neuroimaging, and a prior history of research collaboration,
will conduct the project.
• Men and women age 18-40 years with vision corrected to at least 20-40 (needed for fMRI
tasks)
• Education of ≥ 12 years
• Baseline RAVLT total words recalled T-score ≥ 40 (normal range)
• BMI between 18.5-35.0 (neither underweight nor severely obese)
• Baseline QIDS-C ≤ 5 (virtual absence of depressive symptoms) for "healthy controls"
and for the "depressed" group a QIDS-C between 11-20 (≥ moderate depressive symptoms
but < very severe depressive symptoms)
Exclusion Criteria:
• History of major psychiatric illness other than MDD for the depressed group, defined
as bipolar disorder, posttraumatic stress disorder, schizoaffective disorder,
schizophrenia, eating disorders, or MDD with psychotic features. For the control
group, a past episode of MDD (per SCID) is also exclusionary
• History of drug or alcohol use disorder
• History of neurological disorders including seizures, brain surgery, multiple
sclerosis, Parkinson's disease
• Taking CNS-acting medications (e.g., antidepressants, antipsychotics, lithium,
anticonvulsants, sedative/hypnotic/anxiolytics). Thus, the depressed group will be
medication free.
• History of allergic reaction or medical contraindication to hydrocortisone
• Metal implants, claustrophobia, or other contraindications to MRI
• Significant medical conditions (e.g., cancer, heart disease, diabetes)
• Vulnerable population including pregnant or nursing women, prisoners, and people with
intellectual disability, history of special education classes, dementia, or other
severe cognitive disorders
• Current suicidal ideation, a suicide attempt in the past 12 months or more than one
lifetime attempt
• History of systemic CS use in the past 12 months, lifetime cumulative use of more than
12 weeks, or recent (defined as past 28 days) inhaled CS use
• Women who are using estrogen containing oral contraceptive agents (other
contraceptives are acceptable, see Protection of Human Subjects section for a list of
acceptable birth control methods) or who are post- or peri-menopausal or with
irregular menstrual cycles (i.e., inconsistent menstruation patterns)
Impact of Intensive Treatment of SBP on Brain Perfusion, Amyloid, and Tau (IPAT Study) (IPAT)
The purpose of this study is to determine if intensive lowering of systolic blood pressure
(SBP), using FDA approved medications (antihypertensive), reduces Alzheimer's Disease
pathology (i.e., excessive brain amyloid and tau protein deposition) in older adults at high
risk for memory decline or dementia.
• Age 60-80, all races/ethnicities, and both sexes are eligible;
• a) A positive family history of dementia defined as having at least one first-degree
relative with a history of AD or other type of dementia or
• b) having subjective memory complaints defined as a positive answer to BOTH of the
following questions:
1. "Are you worried about your memory or thinking abilities?
a) Not at all, b) A little bit, c) A lot"; B and C •includes
2. "Do you feel you have difficulty with your memory or thinking that is worse than
in the past?" b) Yes or No; Yes •includes
• Mini-Mental State Exam (MMSE) ≥ 26 to exclude gross dementia; based on clinical
judgment, may be rescreened in ≥ 7 days;
• Individuals with SBP ≥ 130 and SBP ≤ 180; Those on antihypertensives are eligible. If
an individual, not treated for HTN, has a SBP ≥ 125 mmHg, consider rescreening after
24 hours;
• Willingness to be randomized into the treatment groups and ability to return to clinic
for follow-up visits over 24 months;
• Fluency in English or Spanish or both, adequate visual and auditory acuity to allow
neuropsychological testing;
• Participants must have a regular healthcare provider.
Exclusion Criteria:
• Clinically documented history of stroke, focal neurological signs or other major
cerebrovascular diseases based on clinical judgment or MRI/CT scans such as evidence
of infection, infarction, or other brain lesions;
• Diagnosis of AD or other type of dementia, or significant neurologic diseases such as
Parkinson's disease, seizure disorder, multiple sclerosis, history of severe head
trauma or normal pressure hydrocephalus;
• Evidence of severe major depression (GDS ≥ 12, may be rescreened after 12 weeks or
longer if evidence of reactive depression or temporary mood disturbances) or
clinically significant psychopathology, (e.g., psychosis and schizophrenia); if
hospitalized in past year, can be rescreened in 6 months; or presence of a major
psychiatric disorder that in the investigator's opinion, could interfere with
adherence to research assessments or procedures.
• Unstable heart disease based on clinical judgment (e.g., heart attack/cardiac arrest,
cardiac bypass procedures within previous 6 months and congestive heart failure), or
other severe medical conditions;
• History of atrial fibrillation and evidence on ECG with any of the following: active
symptoms of persistent palpitation, dizziness, history of syncope, chest pain,
dyspnea, orthopnea, shortness of breath at rest, or paroxysmal nocturnal dyspnea
within the past 6 months; resting heart rate of < 30 or > 110 bpm; taking class I or
III antiarrhythmic drugs including flecainide, propafenone, dronedarone, sotalol,
dofetilide, and amiodarone; or clinical concerns for safely participating in lowering
blood pressure.
• Systolic BP equal or greater than 180 mmHg and/or diastolic BP equal or greater than
110 mmHg, may be rescreened in 1 week.
• Orthostatic hypotension, defined as the third standing SBP < 100mmHg, may be
rescreened after 2 weeks;
• History of significant autoimmune disorders such as systemic lupus erythematosus,
rheumatoid arthritis or polymyalgia rheumatica;
• Significant history of alcoholism or drug abuse within the last five years;
• Uncontrolled diabetes mellitus, defined as hemoglobin A1C > 6.5%, or requiring insulin
treatment;
• Clinically diagnosed and untreated sleep apnea;
• Regularly smoking cigarettes within the past year;
• Pacemaker or other medical device of metal that precludes performing MRI;
• Women with a potential for pregnancy, lactation/childbearing (2 year post-menopausal
or surgically sterile to be considered not childbearing potential);
• Participant enrolled in another investigational drug or device study, either currently
or within the past 2 months;
• Severe obesity with BMI > 40 ; clinical judgment should be applied in all cases to
assess patient safety and anticipated compliance;
• Allergy to angiotensin receptor blockers (ARBs), i.e., drugs that have a suffix
"-sartan"; allergy to amlodipine;
• Abnormal screening laboratory tests (e.g., liver ALT and AST > 3 x ULN, GFR < 30 or
Hct < 28%); may be rescreened after 2 weeks or longer;
• A medical condition likely to limit survival to less than 3 years;
• Participant has any condition(s) judged by the study investigator to be medically
inappropriate, risky or likely to cause poor study compliance. For example:
1. Plans to move outside the clinic catchment area in the next 2 years;
2. Significant concerns about participation in the study from spouse, significant
other, or family members;
3. Lack of support from primary health care provider;
4. Residence too far from the study clinic site such that transportation is a
barrier including persons who require transportation assistance provided by the
study clinic funds for screening or randomization visits;
5. Residence in a nursing home; persons residing in an assisted living or retirement
community are eligible if they meet the other criteria;
6. Other medical, psychiatric, or behavioral factors that, in the judgment of the
site PI or clinician, may interfere with study participation or the ability to
follow the study Protocol.
7. Couples or significant partners who live together cannot be enrolled or
participate simultaneously in the study.
Drug: Angiotensin II Receptor Blockers (ARBs, losartan) and Calcium Channel Blockers (CCB, amlodipine), Other: PCP
Hypertension, Cognitively Normal Older Adults, Subjective Cognitive Decline, Brain and Nervous System, Family History of Dementia
Dementia, Alzheimer's Disease, Cognitive Function, Blood Pressure, Amyloid, Tau
Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Work in People Who Have a Body Weight Above the Healthy Range (OASIS 4)
This study will look how well semaglutide tablets taken once daily helps people with body
weight above the healthy range. Participants will either get semaglutide 25 milligram (mg)
once daily or placebo once daily. This study will last for 72 weeks, which includes 1-week
screening period, 64 weeks of treatment period and 7 weeks of follow up period.
• Informed consent obtained before any study-related activities. Study-related
activities are any procedures that are carried out as part of the study, including
activities to determine suitability for the study
• Male or female, age greater than or equal to 18 years at the time of signing informed
consent
• Body mass index (BMI) of
• Greater than or equal to 27.0 kg/m^2 with the presence of at least one of the
following weight-related complications (treated or untreated): hypertension,
dyslipidaemia, obstructive sleep apnoea or cardiovascular (CV) disease OR
• Greater than or equal to 30.0 kg/m^2
• History of at least one self-reported unsuccessful dietary effort to lose body weight
Exclusion Criteria:
• A self-reported change in body weight greater than 5 kg (11 pound [lbs]) within 90
days before screening irrespective of medical records
• HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central
laboratory at screening
• Healthy male and female individuals
• 18-35 years or 65+ years of age
• Free of any underlying moderate to serious medical conditions
Exclusion Criteria:
• Known heart disease; other chronic medical conditions requiring regular medical
therapy including cancer, diabetes, neurological diseases, uncontrolled hypertension,
and uncontrolled hypercholesterolemia.
• Taking of any medications (such as beta blockers and non-dihydropyridine calcium
channel blockers) that have known influences on either cardiac function or sweating
responses.
• Abnormalities detected on routine screening.
• Individuals who participate in a structured aerobic exercise training program at
moderate to high intensities.
• Current smokers, as well as individuals who regularly smoked within the past 3 years.
• Body mass index of greater than 30 kg/m^2
• Pregnant individuals
Youth Depression and Suicide Research Network (YDSRN)
The objective of this study is to build the Texas Youth Depression and Suicide Research
Network to support the development of a Network Participant Registry and characterization of
systems and interventions to examine statewide population health outcomes. All 12-13 sites
represented in the Texas Child Mental Health Care Consortium
(https://www.utsystem.edu/pophealth/tcmhcc/) have been invited to participate in the Texas
Youth Depression and Suicide Research Network as "Nodes." 12 Nodes have been selected for
this project. Each Node has obtained support of senior institutional leadership including the
department chair. Leadership from each Node provided input and edits in the study design
process by committee, with a focus on the inclusion of the "end user" in design decisions.
Nodes will work closely with the Network Hub leadership to recruit, monitor, and retain
participants. This will require active engagement and sustained relationships with clinics
within the academic medical center as well as clinics in the community (i.e., psychiatry,
psychology, counselling).
1. Be 8 to 20 years of age;
2. Have a positive screen for depression (e.g., based on PHQ-2 (score ≥3) and/or PHQ-A of
10 or greater, OR positive for suicidal ideation or behavior (e.g., based on CHRT-SR
or PHQ-A item 9); OR be in treatment for depression;
3. Be willing to provide consent/assent (parents/LAR/guardian or young adult participant,
aged 18-20, must be willing to provide consent; youth, aged 8-17, must be willing to
provide assent);
4. Be able to speak English or Spanish sufficiently to understand the study procedures
and provide written informed consent to participate in the study;
5. Be willing to dedicate appropriate time to complete scheduled study assessments and
measures (both parent/LAR/guardian and youth).
6. Be able to provide a reliable means of contact.
Exclusion Criteria:
1. Have an acute medical or psychological condition(s) that that would, in the judgment
of the study medical clinician, make participation difficult or unsafe;
2. Have an acute medical or psychological condition(s) that would result in an inability
to accurately complete study requirements (e.g., neurological conditions or
significant neurodevelopmental concerns);
3. Have active psychotic symptoms resulting in altered mental status and inability to
provide assent or requiring immediate attention and/or higher level of intervention;
4. Have a parent/LAR/guardian who is deemed cognitively unable to provide consent (if
youth participant, aged 8-17).
The purposes of this project are 1) to compare the impact of maternal obesity versus
excessive gestational weight gain on obstructive sleep apnea (OSA) in obese and non-obese
women; 2) to investigate the mechanism(s) by which obesity and OSA increase cardiovascular
risk during pregnancy; and 3) to identify biomarker(s) for obesity-related OSA in pregnant
women.
• Both obese and non-obese (normal weight) early pregnant women aged ≥18 years old will
be permitted to participate in this project.
• No restriction with respect to race and socioeconomic status
• Women with a prior history of complicated pregnancy (i.e., gestational hypertension,
preeclampsia, HELLP syndrome, gestational diabetes, preterm birth, intrauterine growth
restriction, etc.) will be allowed to participate.
• Obese women with previously diagnosed OSA will be allowed to participate if they are
not currently on any recognized treatments such as Continuous Positive Airway Pressure
(CPAP), oral appliances or nasal expiratory positive airway pressure.
• Those who have had surgery for OSA in the past will be excluded.
• Women taking low-dose aspirin will be allowed to participate in this project.
Exclusion Criteria:
• Current multiple pregnancy;
• Known major fetal chromosomal or anatomical abnormalities;
• Recurrent miscarriage (three or more);
• Chronic essential hypertension (systolic BP >140 mmHg and/or diastolic BP >90 mmHg);
• Any evidence of cardiovascular and pulmonary diseases by history or by physical
examination;
• Kidney disease (serum creatinine >1.5 mg/dL);
• Coagulation disorders;
• Diabetes mellitus (fasting glucose ≥126 mg/dL or 2-hour oral glucose tolerance test
glucose level ≥200 mg/dL) or other systemic illness;
• Any evidence of neurological disease;
• Psychiatric disease or psychological disorders;
• History of drug or alcohol abuse within the last 2 years; and
• Given the effects of exercise training on sympathetic neural control,
endurance-trained athletes will be excluded. As this project focuses on sleep apnea in
pregnancy, Women with other significant sleep disorders such as restless legs syndrome
by Rest Leg Syndrome Diagnostic Index and insomnia by the Insomnia Severity Index or
Pittsburgh Sleep Quality Index will be excluded; In addition, women who report taking
a sleeping aid >1 time per month will be excluded.
Aging and Disease Course: Contributions to Lifespan Neurobiology of Schizophrenia
The 2020 NIMH Strategic Plan for Research calls for investigations targeting neurobiology of
mental illness across the lifespan. Growing evidence suggests that lifespan neurobiology of
schizophrenia (SZ) incorporates two distinct dimensions: aging and disease course. However,
their clinical correlates, associated biomarker trajectories, and implications for treatment
are unknown. This study will investigate differential aspects of SZ neurobiology captured by
aging and disease course, in order to develop specific biomarkers which may offer actionable
targets for SZ stage-dependent intervention. The study is predicated on a novel mechanistic
Model of SZ Trajectories across the Adult Lifespan, positing distinct biological fingerprints
within the anterior limbic system for aging and disease course in SZ: (1) alterations in the
circuit's function and structure that occur earlier in the lifespan and are larger in
magnitude than the alterations expected with normal aging (accelerated aging dimension); and
(2) regionally-specific anterior limbic "hyperactivity" in early SZ, with a subsequent
transformation into "hypoactivity" in advanced SZ (disease course dimension). In a sample of
SZ and matched healthy controls (n=168, 84/group) aged 18-75 years the investigators will
ascertain a broad panel of biomarkers [via multimodal brain imaging: optimized 1H-MRS,
high-resolution task-based fMRI, perfusion (Vascular Space Occupancy) and structural MRI],
along with comprehensive cognitive and clinical assessments. All measures will be acquired at
baseline and repeated at 2-year longitudinal follow-up. Using cutting-edge computational
approaches, the study will examine (i) effects of aging and SZ course on anterior limbic
system biomarkers; (ii) lifespan trajectories for different biomarkers; (iii) patterns of
limbic system biomarkers in age- and SZ course-based subgroups (e.g., Younger vs. Older,
Early-Course vs. Advanced SZ), as well as in data-driven subgroups (e.g., those with vs.
without accelerated aging profiles); and (iv) associations between biomarkers and cognitive
and clinical outcomes. This research will advance the field by providing novel biomarkers
that capture unique neurobiological contributions of aging and disease course in SZ, and will
motivate future studies on SZ mechanisms across the lifespan and development of precision
treatments.
• 18-65 years of age (SZ); 18-75 years of age (CON)
• Women and men
• All races and ethnicities
• Psychiatric diagnoses:
Patient participants (SZ): Meet DSM-5 criteria for schizophrenia or schizoaffective
disorder Healthy control participants (CON): No personal history of lifetime psychiatric
disorders, or a family history of psychotic disorders in 1st-or 2nd- degree relatives
• Able to read, speak, and understand English
• Able and willing to provide written informed consent; and willing to commit to the
study protocol, including 2-year longitudinal follow-up
Exclusion Criteria:
• Compromised cognitive function: Both SZ and CON participants: Estimated premorbid
intellectual ability <75 age-corrected score on Wide Range Achievement Test-4/Word Reading
Subtest (WRAT-4) CON participants: <26 score on the Montreal Cognitive Assessment (MoCA)
• Neurological or medical disorder that may affect brain function (history of stroke,
head injury with a loss of consciousness >10 min, seizure disorder, AIDS, poorly
controlled hypertension, poorly controlled diabetes, decompensated lung disease, etc.)
• Co-morbid DSM-5 diagnosis of drug/alcohol use disorder in prior 3 months
• Current treatment with benzodiazepine or non-benzodiazepine sedatives/hypnotics,
and/or anticonvulsants
• Presence of ferromagnetic objects in body
• Weight or body size exceeding MRI scanner capacity [>300 lbs]
• Claustrophobia in MRI scanner
• Pregnant women
• Breastfeeding women (VASO scan will not be administered. All other imaging modalities
are safe to administer.)
• Impaired kidney function: Glomerular Filtration Rate (GFR) < 30 ml/min/1.73m2 (VASO
scan will not be administered due to an association between Gadolinium-based MR
contrast use and Nephrogenic Systemic Fibrosis in individuals with severely impaired
renal function. All other imaging modalities are safe to administer.)
• History of hypersensitivity to any MRI contrast agent (VASO scan will not be
administered. All other imaging modalities are safe to administer.)