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852 Study Matches

The PATHway Study: Primary Care Based Depression Prevention in Adolescents (PATHway)

studyfinder@utsouthwestern.edu
All
13 Years to 18 Years old
N/A
This study is also accepting healthy volunteers
NCT05203198
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Inclusion Criteria:

• Adolescents ages 13 through 18 years, and
• Adolescents must be experiencing an elevated level of depressive symptoms (PHQ-9 = 7-18), and
• Adolescents will be included if they have had past depressive episode/s, but not if they are in a current depressive episode.
Exclusion Criteria:
1. Outside age range: 1. 12 or younger 2. 19 or older 2. Adolescent is a non-English speaker/reader 3. On the PHQ-9 screening, depression symptom level is: 1. PHQ-9 = 6 or lower 2. PHQ-9 =19 or higher 4. As assessed by the MINI Kid, a current depressive episode 5. As assessed by the MINI Kid, adolescent meets DSM-5 criteria for a psychotic or bipolar disorder. 6. Currently using medication therapy for depression, anxiety, or other internalizing disorders. 7. Currently engaged in individual treatment for a mood disorder (assessed by BCC during phone screen) 8. Currently engaged in a cognitive-behavioral group or therapy (assessed by BCC during phone screen) 9. Any past psychiatric hospitalizations 10. Any past suicide attempt or incident of self-harm with moderate or greater lethality 11. Extreme, current drug/alcohol abuse (determined by clinician follow up following a score of 3 or greater on the CRAFFT) 12. Current suicidal thoughts 1. Eligibility will be determined on a case-by-case basis during the baseline PhQ-9 and MINI Kid assessment process and after a consultation with a licensed mental health clinician has taken place. If adolescent report suicidal ideation on the baseline PhQ-9, and found ineligible, the MINI Kid assessment may not be required. 2. Adolescents with current (within the past 6 months), active suicidal feelings will be excluded. 3. Adolescents with passive thoughts of death or suicide but report to the mental health clinician that they would never act on these thoughts may be admitted, depending on the severity of the risk. 4. Adolescents with past (greater than 6 months ago) ideation who are determined to be low risk will be admitted into the study if there has never been an attempt of moderate or greater lethality. 13. Significant reading impairment (a minimum sixth-grade reading level based on parental report) and/or significant intellectual or developmental disabilities 14. Not willing to comply with the study protocol 15. Did not complete phone assessment with MINI Kid by BCC 16. Not affiliated with any of the sites listed in Appendix A. 17. Parent/guardian does not speak English or Spanish 18. Parent/guardian has a cognitive or intellectual impairment 19. Participant Declined/Changed Mind/Uninterested in participating
Behavioral: Competent Adulthood Transition with Cognitive-Behavioral, Humanistic and Interpersonal Training
Depression, Mental Disorder in Adolescence
Adolescents Depression, Internet intervention, Cognitive-Behavioral Therapy, Prevention, MOST design
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Diaphragmatic Hernia Research & Exploration, Advancing Molecular Science (DHREAMS)

The goal of this study is to identify genes that convey susceptibility to congenital diaphragmatic hernia in humans. The identification of such genes, and examination of their structure and function, will enable a delineation of molecular pathogenesis and, ultimately, prevention or treatment of congenital diaphragmatic hernia. There are many different possible modes of inheritance for congenital anomalies, including autosomal dominant, autosomal recessive, and multifactorial. Multi-factorial inheritance is responsible for many common medical disorders, including hypertension, myocardial infarction, diabetes and cancer. This type of inheritance pattern appears to involve environmental factors as well as a combination of genetic variations that together can predispose to or produce congenital anomalies, such as congenital diaphragmatic hernia. Our study is designed to establish a small, well-defined genetic resource consisting of 1) Nuclear families suitable for linkage analysis by parametric,non-parametric (e.g. sib pairs, TDT) and association techniques, 2) Individuals with congenital diaphragmatic hernia who can be directly screened for allelic variation in candidate genes, and 3) Individuals who can serve as controls (are unaffected by congenital diaphragmatic hernia). Neonates and their families will be collected from homogenous and heterogeneous populations. By characterizing diverse populations, it should be possible to increase the likelihood of demonstration of genetic variation in selected candidate genes that can then be used in association and linkage studies in individual subjects with congenital diaphragmatic hernia.
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studyfinder@utsouthwestern.edu
David Schindel
69697
All
Not specified
N/A
This study is also accepting healthy volunteers
NCT00950118
STU 102014-040
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Inclusion Criteria:

• All individuals affected with a congenital diaphragmatic hernia (CDH), or with a family history of a CDH
Exclusion Criteria:

• Individuals with no personal history of a CDH or family history of a family member affected with congenital diaphragmatic hernia
Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia (CDH), Genes, Genetic, Genetic testing, exome sequencing, genome sequencing, RNAseq
Parkland Health & Hospital System
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Morphea in Adults and Children (MAC) Cohort Study: A Morphea Registry and DNA Repository (MAC)

The Morphea in Adults and Children (MAC) cohort is the first registry for both children and adults with morphea (also known as localized scleroderma) in the country. The purpose of the registry is to learn more about morphea, specifically: - How morphea behaves over time - How frequently specific problems occur along with morphea (for example, arthritis) - Whether morphea has an autoimmune background
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Heidi Jacobe
54629
All
up to 90 Years old
N/A
This study is also accepting healthy volunteers
NCT01808937
STU 112010-028
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Inclusion Criteria:
1. Patient must have a clinical diagnosis of morphea confirmed by the primary investigator and by histopathological examination. 2. Ages 0-90 years old 3. Children must weigh more than 20 lbs. in order to satisfy Children's Medical Center policy for the maximum amount of blood drawn in a 24 hour period. 4. Patient or legal guardian must be able to speak and read at a 6th grade reading level. 5. Both male and female patients will be eligible 6. All races and ethnic backgrounds will be included 7. Relationships to proband: All patients with morphea will be included. A patient's family history will be reviewed and if there is a family history of morphea or systemic sclerosis then we will give the study patient the investigator's contact information and ask the family member to call the study team to answer any questions and enroll them in the study if they choose to do so. 8. Ability to give informed consent: Patients must be able to give informed consent or they will give assent with parent or guardian consent as a minor to be a part of the morphea registry.
Exclusion Criteria:

•Patients who have been coded as morphea (701.0), but do not have morphea/localized scleroderma (examples: steroid atrophy, acquired keratoderma, keloids, nephrogenic fibrosing dermopathy, systemic sclerosis, lichen sclerosis)
Other: Morphea
Scleroderma, Localized, Morphea, Scleroderma, Circumscribed, Frontal Linear Scleroderma en Coup de Sabre, Scleroderma, Linear, Other Skin
Children’s Health
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13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF (ALFSG-MBT)

The ALFSG-MBT protocol is for a multicenter, open label, non-randomized study to determine the value of Breath Identification® (BreathID®) N-(4-Methoxy-13C-phenyl)acetamide (13C-Methacetin) Breath Test System in predicting the outcome of patients diagnosed with severe acute liver injury that is not related to acetaminophen overdose or acute liver failure who meet inclusion/exclusion criteria. Up to 200 evaluable patients will be enrolled. An evaluable patient is one who has completed one or more breath tests for at least 30 minutes after administration of the 13C-Methacetin solution (test substrate). The Breath Test will be performed up to five times during the study period on all enrolled patients. The first Breath Test will be performed upon admission into the study (Day 1) and repeated on Days 2, 3, 5 and 7 provided no contra-indications are present. Each test continuously measures changes in the metabolism of the 13C-Methacetin in order to assess the improvement or deterioration in liver metabolic function about improvement or deterioration in liver metabolic function. If an enrolled non-APAP ALI or ALF patient receives a liver transplant, is discharged /transferred from the hospital or dies prior to Day 7, additional Breath Tests will not be performed. Patients will be contacted for the Day 21 follow up (21 days after enrollment into the trial) to determine spontaneous survival, transplantation and occurrence of serious adverse events since the patient's last study treatment.
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William Lee
14217
All
18 Years to 80 Years old
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT02786836
STU 122015-008
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Inclusion Criteria:
1. Adult men or women (18-80 years of age) 2. Severe acute liver injury not related to acetaminophen overdose: INR ≥2.0; no evidence of HE 3. Acute liver failure: INR ≥1.5; presence of any degree of HE 4. Duration of illness <26 weeks 5. Enrolled into the ALFSG Registry. 6. Written informed consent from the patient or patient's legally authorized representative or family member as defined in the Federal Register Number 21 Congressional Federal Register (CFR)50.3(m)
Exclusion Criteria:
1. Evidence of pre-existing chronic liver disease 2. Pre-existing New York Heart Association stage III/IV heart failure 3. Evidence of pre-existing chronic renal failure 4. Chronic hemodialysis prior to hospital admission 5. Evidence of cirrhosis (unless clinically acute Wilson disease or autoimmune non-APAP ALI or ALF) 6. Severe obstructive lung disease (FEV1 <50% of predicted on previous spirometry) 7. Severe shock, defined as mean arterial pressure (MAP) <70 mmHg despite >15 µg/kg/min dopamine, >0.1 µg/kg/min epinephrine, or >0.1 norepinephrine µg/kg/min 8. Extensive small bowel resection (>50 cm) 9. Any evidence of upper GI bleeding at enrollment requiring intervention (endoscopy or red blood cell (RBC) transfusion specifically for upper GI bleeding) 10. Liver transplantation (LT) prior to enrollment. (Note: Listing for LT does not preclude participation in the trial.) 11. Pregnancy or breastfeeding women (Note: Pregnancy related non-APAP ALI or ALF may be considered for entry following the delivery of the baby and assuming the mother does not wish to breastfeed or collect breast milk during the study period.) 12. Allergic to acetaminophen (such as Tylenol® or any other acetaminophen-containing medications) 13. Participation in other clinical studies evaluating other experimental treatments or procedures. (Note: Participation in observatory studies is not an exclusion.) 14. Patients in whom enteral drugs or fluids are contra-indicated or the patient either does not have an appropriately placed naso-enteric/orogastric tube in situ or cannot tolerate taking the drug preparation orally (200 ml) 15. Budd-Chiari Syndrome 16. Non-APAP ALI or ALF caused by malignancy 17. Moderate and severe adult respiratory distress syndrome (ARDS), as defined by Berlin Criteria. 18. Subjects who have received amiodarone in the 30 days prior to study enrollment 19. Consumption of any food or beverage that contains caffeine in the 24 hours prior to enrollment 20. Consumption of any of the following drugs that may interfere with the metabolism of 13C-Methacetin in the 48 hours prior to study enrollment including: allopurinol, carbamazepine, cimetidine, ciprofloxacin, daidzein, disulfiram, Echinacea, enoxacin, fluvoxamine, methoxsalen, mexiletine, montelukast, norfloxacin, phenylpropanolamine, phenytoin, propafenone, rifampin, terbinafine, ticlopidine, thiabendazole, verapamil, zileuton or oral contraceptives 21. Consumption of alcohol in the 24 hours prior to enrollment 22. Smoking cigarettes in the 8 hours prior to enrollment.
Drug: 13C-Methacetin
Acute Liver Failure
acute liver failure, methacetin, breath test, severe acute liver injury, hepatic encephalopathy, ALFSG Registry, acetaminophen toxicity
UT Southwestern
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Mechanisms of Early Recurrence in Intracranial Atherosclerotic Disease (MyRIAD)

The objective of this study is to determine the mechanisms of stroke in patients with Intracranial Atherosclerotic Disease (IAD) by specifically evaluating limitations of antegrade flow through the stenotic artery, distal tissue perfusion to the affected territory, and artery-to-artery embolism. The hypothesis is that non-invasive imaging biomarkers that stratify stroke risk and distinguish mechanisms of IAD. This prospective multicenter study will enroll 175 patients with recently symptomatic high-grade IAD. Patients will be studied within 21 days of the index event (allowing appropriate time to arrange for diverse imaging modalities), with the following advanced neuroimaging techniques to elucidate mechanisms of recurrent ischemia: - Quantitative magnetic resonance imaging (QMRA) to assess volumetric flow rate through the stenotic artery. - Magnetic resonance perfusion weighted imaging (PWI-MRI) to determine distal tissue perfusion. - Vasomotor reactivity by Transcranial Doppler using the breath-holding technique (BHI-TCD) to assess compensatory flow characteristics to the territory distal to the affected artery; - Transcranial Doppler with embolic signal monitoring to evaluate artery-to-artery embolism that reflects plaque instability. Patients will receive standardized medical management and its effectiveness on blood pressure, lipid, and glycemic control will be monitored. The primary outcome is recurrent stroke in the territory of the stenotic artery during a 1-year follow-up period; secondary outcomes are: a) new asymptomatic ischemic lesions on MRI in the distribution of the stenotic artery at 6-8 weeks, and b) transient ischemic attack (TIA) in the distribution of the stenotic artery during a 1-year follow-up period. Patients will be recruited at various sites that will be trained and certified on the imaging techniques employed. Raw imaging data will be interpreted centrally.
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Mark Johnson
36153
All
30 Years to 99 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02121028
STU 092014-021
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Inclusion Criteria:
1. Stroke defined as symptoms lasting >24 hours and associated with imaging evidence of acute ischemia in the distribution of the stenotic vessel on CT or MRI. 2. Eligible TIA defined as transient neurological symptoms lasting <24 hours, need to be: 1. accompanied by DWI abnormalities in the distribution of the stenotic artery; or 2. multiple (≥2), stereotyped events associated with unequivocal ischemic symptoms (weakness, aphasia), and attributed to the symptomatic artery. 3. IAD should involve the intracranial carotid, middle cerebral, intracranial vertebral or basilar arteries. 4. Stenosis 50-99% quantified by digital subtraction angiography (DSA), CT angiography-CTA or MR angiography-MRA tests. DSA is not required but will be used if obtained as part of clinical care. The criteria for 50-99% are: 1. CTA or DSA: measured 50-99% stenosis by WASID criteria (percent stenosis = (1-[diameter stenosis/diameter normal]) x 100%. 2. MRA: measured 50-99% stenosis or presence of a flow gap. 5. Age >30; those 30-49 years of age must also have the presence of established atherosclerotic disease in another vascular bed (coronary, extracranial carotid, peripheral) or the presence of 2 or more risk factors (hypertension, diabetes mellitus, hyperlipidemia, tobacco abuse within the last 2 years). 6. Enrollment within 21 days of symptom onset and completion of study imaging tests within 21 days of index event (stroke or TIA). 7. Provide informed consent for participation in the study.
Exclusion Criteria:
1. Other cause for stroke: atrial fibrillation, acute anterior wall ST-elevation myocardial infarction <30days, mitral stenosis, mechanical valve, intracardiac thrombus or vegetation, dilated cardiomyopathy or ejection fraction <30%, proximal extracranial carotid or vertebral stenosis >50%. 2. Contraindications to MRI, including MR-incompatible metallic implants, implanted electronic devices, other potentially mobile ferromagnetic material, pregnancy (women in fertile age should have a negative pregnancy test), lactation, morbid obesity, and severe claustrophobia. 3. Renal impairment defined as either a creatinine level >1.5 mg/dL or a glomerular filtration rate (GFR) <30 mL/min/1.73 m2. 4. Known allergy to gadolinium. 5. Unable to obtain informed consent by patient or legally authorized representative. 6. Severe behavioral or social problems that may interfere with the conduct of the study. 7. In the investigator's opinion, patient unlikely return for follow up visit and to complete the study. 8. Participation in a drug or device clinical trial within the last 30 days.
Intracranial Vascular Disorders, Head and Neck
Intracranial Atherosclerotic Disease, Stroke, Transient Ischemic Attack, Imaging
Parkland Health & Hospital System
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Low-dose UVA1 Radiation in Cutaneous Lupus Patients

The investigators are conducting an open-label clinical trial determining the effects of UVA1 phototherapy on cutaneous lupus (CLE) patients. Past research on systemic lupus (SLE) subjects indicates that this treatment is likely to be effective in treating cutaneous lupus with few side effects. The fact that most CLE patients are seen at dermatology clinics also increases the usefulness of this study because there is a large probability that phototherapy treatment will be accessible for many of the patients that stand to benefit from it.
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Benjamin Chong
99998
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT01776190
STU 072012-024
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Inclusion Criteria:

• You must be 18 years or older with a diagnosis of cutaneous lupus.
• You must have at least two active areas of cutaneous lupus.
• You will need to come in three days a week for a 10-week period.
• You will need to participate in four physician visits and blood draws.
Exclusion Criteria:

• You do not have a diagnosis of cutaneous lupus.
• You have less than two active areas of cutaneous lupus.
• You are unable to come in three days a week for treatment for a 10-week period.
Device: UVA1 radiation treatment
Cutaneous Lupus Erythematosus, Other Skin
Parkland Health & Hospital System
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Database Registry for Neural Network Biomarkers in Psychosis (Imaging)

Several observations have been made with magnetic resonance imaging (MRI) that characterize brain connections and brain function in individuals with schizophrenia and other mental disorders. For example, research investigating schizophrenia focuses on the dysfunction of connections within and between the medial temporal lobe and the prefrontal cortex as well as other pertinent brain regions. This database registry will allow for the collection of clinical interview data, behavioral data, blood, magnetic resonance imaging (MRI) data, and functional magnetic resonance imaging (fMRI) data on individuals with and without mental disorders to better understand how connections in the brain and various brain regions function differently while volunteers perform various cognitive tasks. This is an observational study that is being conducted to collect data and place it in a registry for current and future investigational questions related to imaging in mental disorders.
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Carol Tamminga
58406
All
18 Years to 60 Years old
N/A
This study is also accepting healthy volunteers
NCT01409109
STU 062010-095
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Inclusion Criteria:
Volunteers with Schizophrenia or other mental illness
• Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnosis of Schizophrenia or Schizoaffective disorder
• Competent to give informed consent
• All races and ethnicities
• Eyesight corrected to 20-40 or better
• Able to read, speak, and understand English
Healthy volunteers

• No past or current severe mental illness
• All races and ethnicities
• Eyesight corrected to 20-40 or better
• Able to read, speak, and understand English
Exclusion Criteria:
Volunteers with schizophrenia or other mental illness
• Diagnosis of an organic brain disease
• Diagnosis of DSM-IV-TR alcohol or substance abuse within the last month or DSM-IV-TR alcohol or substance dependence within the last three months
• Serious, unstable medical illness
• History of serious head injury
• Pregnant women
Healthy volunteers

• History of psychiatric illness
• Current use of psychoactive drugs excluding nicotine and caffeine
• Diagnosis of an organic brain disease
• Serious, unstable medical illness
• History of serious head injury
• Pregnant women
Schizophrenia, Schizoaffective Disorder, Brain and Nervous System
Schizophrenia, Schizoaffective, Neuroimaging, Magnetic Resonance Imaging (MRI), Functional Magnetic Resonance Imaging (fMRI), Spectroscopy
Parkland Health & Hospital System
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Corneal Sensitivity in Patients With Sleep Apnea Syndrome

This study is a prospective, single center clinical trial to assess corneal sensitivity and nerve fiber morphology in patients with sleep apnea compared to normal controls. Healthy volunteers with no history of ocular or uncontrollable systemic disease will be encouraged to participate in the study. After execution and review of the consenting procedures, a detailed history will be taken and a slit lamp examination performed, verifying ocular health. This consists of an examination of both eyes including assessments of ocular lids, lashes, cornea and conjunctival evaluation. Corneal touch thresholds will be tested with a Cochet-Bonnet aesthesiometer, a standard non-invasive measure of corneal sensitivity. Corneal nerves will be imaged using a modified HRT in vivo confocal microscope. The in vivo confocal microscope allows for high resolution imaging of the nerve plexus under the corneal epithelium. This corneal nerve plexus is responsible for corneal sensitively and changes or loss have been established as an early, sensitive indicator of corneal neuropathy. The investigators anticipate that this study will require approximately 30 patients for each group and will last approximately 12 months for recruitment and completion of subject visit phases. There is only one clinical visit designed for this project, unscheduled visits may be scheduled in case of an adverse event. Patient recruitment will be complete at the one-year time point. At the 14 month time point, all data points will have been collected and assessment of the outcome measure (corneal sensitivity in sleep apnea patients versus control patients) will be complete.
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Danielle Robertson
54987
All
18 Years to 90 Years old
N/A
This study is also accepting healthy volunteers
NCT02265133
STU 102011-033
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Inclusion Criteria:
1. Healthy, non-smoking volunteers. 2. Patients with a diagnosis of sleep apnea. 3. Non-contact lens wearers of any gender and race, ages 18 and up. 4. Minority representation will be proactively encouraged. 5. Patients that are willing to review, understand, and sign the written Informed Consent. 6. Written authorization for use or release of health and research study information. 7. Patients that are willing and able to cooperate with the Investigator and follow all instructions.
Exclusion Criteria:
1. Use of ocular drops including over the counter (OTC) dry eye drops. 2. Previous history of corneal surgery. 3. Previous history of ocular trauma. 4. History of Diabetes Mellitus. 5. Current active or previous history of Herpes virus keratitis. 6. Current or former Contact lens wear. 7. Chronic history of dry eye disease.
Sleep Apnea, Eye and Orbit
Parkland Health & Hospital System
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Dimethyl Fumarate (DMF) Observational Study (ESTEEM)

The primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (SAEs), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events (AEs) leading to treatment discontinuation in patients with MS treated with dimethyl fumarate (DMF). Secondary objectives of this study in this population are as follows: To determine dimethyl fumarate (DMF) prescription and utilization patterns in routine clinical practice in patients with multiple sclerosis (MS); To assess the effectiveness of dimethyl fumarate (DMF) on multiple sclerosis (MS) disease activity and disability progression in routine clinical practice as determined by the Expanded Disability Status Scale (EDSS) score and multiple sclerosis (MS) relapse information; and To assess the effect of dimethyl fumarate (DMF) on health-related quality of life, healthcare resource consumption, and work productivity.
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Darin Okuda
146752
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02047097
STU 032017-026
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Key
Inclusion Criteria:

•Patients with multiple sclerosis (MS) who are newly initiating treatment with dimethyl fumarate (DMF) under routine clinical care are eligible to participate in the study. Key
Exclusion Criteria:

• Patients with previous exposure to dimethyl fumarate (DMF), Fumaderm (fumaric acid esters), or compounded fumarates.
• Patients participating in other clinical studies. NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Drug: dimethyl fumarate
Multiple Sclerosis
UT Southwestern
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Alzheimer's Disease Neuroimaging Initiative 3 (ADNI3) Protocol (ADNI3)

Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) has been realized in informing the design of therapeutic trials in AD. ADNI3 continues the previously funded ADNI-1, ADNI-GO, and ADNI-2 studies that have been combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD). The overall goal of the study is to continue to discover, optimize, standardize, and validate clinical trial measures and biomarkers used in AD research.
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Brendan Kelley
173025
All
55 Years to 90 Years old
N/A
This study is also accepting healthy volunteers
NCT02854033
STU 112016-068
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Inclusion Criteria (all CN participants): 1. Participant with or without subjective memory complaints, verified by a study partner, beyond what one would expect for age 2. Normal memory function documented by scoring above education adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale -Revised (the maximum score is 25): 1. 9 for 16 or more years of education 2. 5 for 8-15 years of education 3. 3 for 0-7 years of education 3. Mini-Mental State Exam score between 24 and 30 inclusive (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director) 4. Clinical Dementia Rating = 0. Memory Box score must be 0 5. Cognitively normal, based on an absence of significant impairment in cognitive functions or activities of daily living 6. Stability of Permitted Medications for at least 4 weeks: 1. Stable doses of antidepressants lacking significant anticholinergic side effects (if they are currently adequately treated for depressive symptoms and do not have a history of major depression within the past 1 years) 2. Estrogen replacement therapy is permissible 3. Gingko biloba is permissible, but discouraged 4. Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening. Inclusion Criteria (all MCI participants): 1. Participant must express a subjective memory concern as reported by participant, or recalled by study partner or clinician. 2. Abnormal memory function documented by scoring below education adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale -Revised (the maximum score is 25): a. < 11 for 16 or more years of education b. ≤ 9 for 8-15 years of education c. ≤ 6 for 0-7 years of education 3. Mini-Mental State Exam score between 24 and 30 inclusive (Exceptions may be made for participants with less than 8 years of education at the discretion of the Project Director) 4. Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5 5. General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's disease cannot be made by the site physician at the time of the Screening Visit 6. Stability of Permitted Medications for at least 4 weeks: 1. Stable doses of antidepressants lacking significant anticholinergic side effects (if they are currently adequately treated for depressive symptoms and do not have a history of major depression within the past 1 years) 2. Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to Screening Visit 3. Estrogen replacement therapy is permissible 4. Gingko biloba is permissible, but discouraged 5. Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening. Inclusion Criteria (all AD participants): 1. Participant must express a subjective memory concern as reported by participant, or recalled by study partner or clinician.n. 2. Abnormal memory function documented by scoring below education adjusted cutoffs on the Logical Memory II subscale (Delayed Paragraph Recall, Paragraph A only) from the Wechsler Memory Scale -Revised (the maximum score is 25): 1. ≤ 8 for 16 or more years of education 2. ≤ 4 for 8-15 years of education 3. ≤ 2 for 0-7 years of education 3. Mini-Mental State Exam score between 20 and 24 inclusive (Exceptions for scores of 24 and 25 may be made for participants with less than 8 years of education at the discretion of the Project Director) 4. Clinical Dementia Rating = 0.5 or 1.0 5. NINCDS (National Institute of Neurological and Communicative Disorders and Stroke) -ADRDA (Alzheimer's Disease and Related Disorders Association) criteria for probable AD 6. Stability of Permitted Medications for at least 4 weeks: 1. Stable doses of antidepressants lacking significant anticholinergic side effects (if they are currently adequately treated for depressive symptoms and do not have a history of major depression within the past 1 years) 2. Cholinesterase inhibitors and memantine are allowable if stable for 12 weeks prior to Screening Visit 3. Estrogen replacement therapy is permissible 4. Gingko biloba is permissible, but discouraged 5. Washout from psychoactive medication (e.g., excluded antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics, etc.) for at least 4 weeks prior to screening. Inclusion Criteria Specific to Newly Enrolled Participants 1. Geriatric Depression Scale score less than 6. 2. Age between 55-90 years (inclusive). 3. Study partner who has frequent contact with the participant (i.e., minimum average of 10 hours per week) and is available to accompany the participant to all clinic visits for the duration of the protocol. 4. Visual and auditory acuity adequate for neuropsychological testing. 5. Good general health with no diseases expected to interfere with the study. 6. Participant is not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile). 7. Willing and able to participate in a longitudinal imaging study. 8. Modified Hachinski Ischemic Score less than or equal to 4. 9. Completed six grades of education or has a good work history (sufficient to exclude mental retardation). 10. Must speak English or Spanish fluently. 11. Willing to undergo repeated MRIs (3Tesla) and at least two PET scans 12. Agrees to collection of blood for genomic analysis (including GWAS (genome-wide association study) sequencing and other analysis), APOE (Apolipoprotein E) testing and biospecimen banking. 13. Agrees to collection of blood for biomarker testing. 14. Agrees to at least one lumbar puncture for the collection of CSF. 15. Agrees to share genomic data and biomarker samples. Inclusion Criteria Specific to Rollover Participants" The following additional inclusion criteria apply to all diagnostic categories for rollover participants only: 1. Must have been enrolled and followed in ADNI-1, ADNI-GO, or ADNI-2 for at least one year. 2. Willing and able to continue to participate in an ongoing longitudinal study. A reduced battery of tests is allowable if the participant is not able/willing to complete the full battery. Exclusion Criteria (all CN participants): 1. Any significant neurologic disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities Exclusion Criteria (all MCI participants): 1. Any significant neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities. Exclusion Criteria (all AD participants): 1. Any significant neurologic disease other than Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities. Exclusion Criteria (all participants): The following additional exclusion criteria apply to all diagnostic categories: 1. Screening/Baseline MRI brain scan with evidence of infection, infarction, or other focal lesions or multiple lacunes or lacunes in a critical memory structure 2. Subjects that have any contraindications for MRI studies, including the presence of cardiac pacemakers, or metal fragments or foreign objects in the eyes, skin or body. 3. Major depression, bipolar disorder as described in DSM-IV within the past 1 year. Psychotic features, agitation or behavioral problems within the last 3 months that could lead to difficulty complying with the protocol. 4. Currently treated with medication for obsessive-compulsive disorder or attention deficit disorder. 5. History of schizophrenia (DSM IV criteria). 6. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria). 7. Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol. 8. Clinically significant abnormalities in B12 or thyroid function tests (TFTs) that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant. 9. Residence in a skilled nursing facility. 10. Current use of specific psychoactive medications (e.g., certain antidepressants, neuroleptics, chronic anxiolytics or sedative hypnotics). Current use of warfarin or other anticoagulants such as dabigatran, rivaroxaban and apixaban (exclusionary for lumbar puncture). 11. Current use of any other exclusionary medications 12. Investigational agents are prohibited one month prior to entry and for the duration of the trial. 13. Participation in clinical studies involving neuropsychological measures being collected more than one time per year. Exclusion Criteria Specific to AV-1451 PET: The following criteria are exclusionary only for the AV-1451 scanning portion of the study: 1. History of risk factors for torsades de pointes (a cardiac dysrhythmia associated with sudden death) or taking medications known to prolong the QT interval. A list of restricted medications will be provided. 2. Have an ECG obtained prior to the AV-1451 PET scan that in the opinion of the investigator is clinically significant with regard to the subject's participation in the study. Bazett's corrected QT (QTcB) interval must be evaluated and must not exceed 458 msec in males, or 474 msec in females.
Mild Cognitive Impairment (MCI), Alzheimer's Disease (AD), Brain and Nervous System
amyloid, plaques, neuroimaging, biomarkers, cognition disorder, early detection, pre-dementia, dementia, Alzheimer's disease, tau
UT Southwestern
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Neuromodulation for Accidental Bowel Leakage (NOTABLe)

This study is a multi-center, randomized clinical trial of women with refractory accidental bowel leakage (ABL) symptoms who have failed to achieve satisfactory symptom control from 2 first-line treatments for ABL: supervised pelvic muscle training (PMT) and constipating medication. The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to a validated sham to determine if PTNS is effective for the treatment of fecal incontinence (FI) in women. The investigators will test the null hypothesis that change from baseline in St. Mark's (Vaizey) score after 12 weeks of stimulation is not significantly different in women with symptomatic ABL receiving PTNS treatments compared to women receiving sham PTNS treatments.
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David Rahn
49553
Female
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03278613
STU 122017-009
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Inclusion Criteria:

• Women ≥ 18 years of age
• FI symptoms ≥ 3 months
• Baseline St. Mark's score of ≥ 12
• Attended ≥ 2 supervised PMT for ABL
• Intolerance, unwillingness, or inadequate response to constipating medications
• Current negative colon cancer screening based on the USPSTF's recommendation for colorectal cancer screening (2016)
Exclusion Criteria:

• Previous PTNS treatment
• History of uncontrolled diarrhea in the past 3 months (usual or most common stool type over the preceding 3 months of 7 on the Bristol Stool Form Scale)
• History of severe constipation in the past 3 months (usual or most common stool type over the preceding 3 months of 1 on the Bristol Stool Form Scale)
• History of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis, but does not include irritable bowel disease)
• Unrepaired rectovaginal fistula/chronic 4th degree laceration
• Full thickness rectal prolapse
• History of congenital anorectal malformation
• History of bowel resection surgery for any indication
• Minor anal procedures within 6 months for treatment of ABL (injection of bulking agent or radiofrequency energy) or ligation of hemorrhoids
• Prior pelvic or abdominal radiation
• Diagnosis of cancer of the descending colon or anus
• Diagnosis of cancer in the region where the PTNS or sham needles or surface electrodes would be placed
• Pacemaker, implantable defibrillator
• Current use of Interstim sacral nerve stimulator or TENS in the pelvic region, back, or legs
• Clinically significant neurological disorders known to affect anal continence
• Coagulopathy
• Severe peripheral edema preventing accurate placement of PTNS needles
• Chronic swollen, infected, inflamed skin or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins) in the region where the PTNS or sham needles or surface electrodes would be placed
• Metal implant in foot/toes near TENS electrode location
• Marked sensory deficit (numbness) of feet or ankles in the region where the PTNS or sham needles or surface electrodes would be placed
• Childbirth within the last 3 months
• Pregnant or planning to become pregnant during the study duration 1 year; a urine pregnancy test will be performed and must be negative by the first intervention visit if the participant is of childbearing potential
• Unwilling to use acceptable form of contraceptive if the participant is of childbearing potential
• Participation in another intervention trial impacting bowel function
• Inability to provide informed consent, complete questionnaires independently, or to attend intervention sessions
• Unable or unwilling to complete the bowel diary in Run-In Phase (valid diary defined as data from ≥ 10 of 14 days with minimum of 3 consecutive days per week)
• Unwilling to download bowel diary app onto smartphone if the participant owns a smartphone
• Visual impairment prohibiting reading the paper diary, the smart phone screen
• Unable to speak, read, or write in English or Spanish at a basic level
Device: ES-130
Fecal Incontinence, Bowel Incontinence
Parkland Health & Hospital System
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Cranial Electrical Stimulation (CES) as Treatment for Insomnia in Patients With Subacute Stroke

This will be a double blinded randomized clinical trial carried out at Zale-Lipshy and Parkland Hospital Inpatient Rehabilitation Facilities. Acute stroke patients with insomnia, identified by the Insomnia Severity Index (ISI), and who choose to participate in this study will be randomized to CES (Cranial Electrical Stimulation) or sham CES. Patients who do not feel they are getting adequate sleep but want to continue in the study will be given the option to receive the standard of care medication as a rescue starting on the 3rd night. Patients will receive treatment with a Fisher-Wallace CES device or Sham CES. Treatment with CES will be for 20 minutes once a day, and the treatment period will be for 7 days. Patients will be allowed to increase the intensity of the device from the suggested starting point of level 2 if they feel no improvement in sleep on night 1. Groups will be monitored with a wrist worn actigraph that records the patient's activity for the duration of the period of study and provides data on sleep latency, time spent asleep, and sleep efficiency. The outcome measures will be total minutes/hours of sleep, sleep efficiency and subjective reports of drowsiness using the Karolinska Sleepiness Scale. Actigraphic data will be collected 24 hours a day for 7 days. The total length of study will be about 24 months with a target N of 100 consented individuals and 85 participants. Patients will be allowed to exit the study at any time on their own choosing. To minimize loss of subjects, patients will have the option to choose SOC rescue starting on the third night. Patients who choose the SOC rescue will continue to be monitored with an actigraph for data collection purposes. The investigator should discontinue study participation for a given subject or withdraw the subject from study if he/she believes that continuation would be detrimental to the subject's well-being. A subject can decide to withdraw from the study at any time and for any reason.
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Amy Mathews
173575
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03344562
STU 072016-005
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Inclusion Criteria:
1. Written informed consent must be obtained. 2. Patients must be admitted to inpatient rehab. 3. Patients must have a documented acute stroke (ischemic, hemorrhagic or embolic). 4. Patients must have at least one fully functional arm which can be used to record actigraph data via a wrist worn actigraph device. 5. Subjects must Score a 7 or higher on the ISI. 6. Patients must be able to communicate consent and/or desire to discontinue the study. Exclusion Criteria 1. Demand or sensing type cardiac pacemaker. 2. Known uncontrolled seizure disorder. 3. Current history of vertigo. 4. Need for continuous O2. 5. Inability to communicate or provide consent. 6. Restricted use or absence of both arms. -
Device: CES, Device: CES
Cerebrovascular Accident, Sleep Disorder
Parkland Health & Hospital System
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Safety and Effectiveness of an Intracranial Aneurysm Embolization System for Treating Large or Giant Wide Neck Aneurysms (SCENT)

This clinical research study is designed to determine safety and effectiveness of the Surpass Flow Diverter (Surpass System), an investigational device developed to treat wide neck, large or giant intracranial aneurysms. An intracranial aneurysm is a bulge in the wall of a blood vessel in the brain. The bulge is caused by a weakening of the vessel wall. If left untreated, the bulge may continue to grow larger and ultimately the vessel may break open (rupture), resulting in serious bleeding into or around the brain. The information collected from this study will be used to evaluate how well patients do when treated with the Surpass System both immediately after treatment of an aneurysm and over a long period of time (5 years).
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Babu Welch
67812
All
19 Years to 80 Years old
N/A
This study is NOT accepting healthy volunteers
NCT01716117
STU 112012-010
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Inclusion Criteria:

• Age 19 to 80 years
• Subject or legal representative is willing and able to give informed consent
• Subject has a single targeted intracranial aneurysm
• Subject agrees to return to the treating Investigator for all scheduled follow up visits and is capable of returning to the hospital for follow up
Exclusion Criteria:

• Known allergy or contraindication to aspirin, clopidogrel/Plavix, heparin, local or general anesthesia
• Known history of life threatening allergy to contrast dye
• Known allergy to nickel, chromium cobalt, tungsten or platinum
• Subject has documented resistance to clopidogrel/Plavix
• Major surgery within previous 30 days or planned in the next 120 days after enrollment date
• Previous intracranial implant associated with the symptomatic distribution within the past 12 weeks prior to treatment date
• Stenting, angioplasty, or endarterectomy of an extracranial (carotid or vertebral artery) or intracranial artery within 30 days prior to treatment date
• Any previous stenting of parent artery at or proximal to the aneurym where it would interfere with the placement and proper apposition of the device
• Any previous coiling where it would interfere with the placement and proper apposition of the device
• Platelet count less than 100,000 cells/mm3 or known platelet dysfunction
• More than one intracranial aneurysm (IA) that requires treatment within 12 months
• Asymptomatic extradural aneurysms requiring treatment
• Contraindication to CT scan or MRI
• Severe neurological deficit that renders the subject incapable of living independently
• Unstable neurological deficit (i.e., worsening of clinical condition in the last 30 days)
• Evidence of active infection at the time of treatment
• Dementia or psychiatric problem that prevents the patient from completing required follow up
• Co-morbid conditions that may limit survival to less than 24 months
• Serum creatinine greater or equal to 2.5 mg/dL
• Female subjects who are pregnant or planning to become pregnant within the study period
• Subject with anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis
• Extra-cranial stenosis or parent vessel with stenosis greater than 50% in the area proximal to the aneurysm
• Other known serious concurrent medical conditions
• History of intracranial vasospasm not responsive to medical therapy
• Subject with an intracranial mass, or is undergoing radiation therapy for carcinoma or sarcoma of the head or neck region
• Subject has a history of bleeding diathesis or coagulopathy, international normalized ratio (INR) greater than 1.5, or will refuse blood transfusions
• Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date
• Subject has a non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm
• Inability to understand the study or a history of non-compliance with medical advice
• Current use of illicit substance
• Enrollment in another trial involving an investigational product
• Subject has a need for long-term use of anticoagulants (i.e., Warfarin, Dabigatran)
Device: Surpass Flow Diverter
Brain Aneurysm, Brain and Nervous System
Large aneurysm, Giant aneurysm, Wide neck aneurysm
UT Southwestern
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Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)

The Intermacs registry is a national quality improvement system designed to advance the understanding and application of mechanical circulatory support in order to improve the duration and quality of life in patients with advanced heart failure.
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studyfinder@utsouthwestern.edu
Matthias Peltz
19035
All
Not specified
This study is NOT accepting healthy volunteers
NCT00119834
STU 082010-019
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Inclusion Criteria:

• Legally utilized MCSD implanted on or after March 1, 2006; every consented patient who receives an eligible MCSD at a participating center will be enrolled, regardless of reason (i.e., bridge-to-recovery, bridge-to-alternative bridge, bridge-to-clinical improvement for transplant eligibility, bridge-to-transplant, destination therapy). Beginning June 1, 2014, and with lnstitutional Review Board approval, participating sites may enroll patients under a waiver of informed consent and authorization.
• Eligible devices include all of the following: 1) approved devices for any indications; 2) Intermacs-linked trial of investigational device or approved device for investigational indications, for which data will be entered via the Intermacs framework; 3) external trial of investigational device or approved device for investigational indications, for which data will be collected by an external group; 4) compassionate use of investigational devices or approved devices outside of approved indications or clinical trials
Exclusion Criteria:

• Currently incarcerated
Device: Mechanical Circulatory Support Device (MCSD)
Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive, Heart
Heart Failure, Intermacs, Pedimacs, Mechanical Circulatory Support, Ventricular Assist Device
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Gan & Lee Insulin Glargine Target Type (2) Evaluating Research (GLITTER 2)

Primary Objective: • To demonstrate equivalence of Gan & Lee Insulin Glargine Injection and Lantus® in terms of immunogenicity Secondary Objective: • Immunogenicity: To evaluate the percentage of subjects with negative anti-insulin antibodies (AIA) at baseline who develop confirmed positive AIA up to Week 26
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Philip Raskin
15956
All
18 Years to 75 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03371108
STU 102017-066
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Inclusion Criteria:

• Type 2 Diabetes
Biological: Gan & Lee Insulin Glargine Injection, Biological: Lantus®
Diabetes Mellitus, Type 2
Diabetes, Diabetes Type 2, Type 2, Basal, Insulin, Glargine, T2DM, Diabetes Mellitus
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Study of BHV-3241 in Subjects With Multiple System Atrophy (M-STAR)

The purpose of this study is to compare the efficacy of BHV-3241 versus placebo in subjects with Multiple System Atrophy
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Steven Vernino
67844
All
40 Years to 80 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03952806
STU-2019-1199
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Inclusion Criteria:
1. Diagnosis of probable or possible MSA according to consensus clinical criteria (Gilman et al 2008), including subjects with MSA of either subtype (MSA-P or MSA-C). 2. Able to ambulate without the assistance of another person, defined as the ability to take at least 10 steps. Use of assistive devices (e.g., walker or cane) is allowed. 3. Anticipated survival of at least 3 years at the time of Screening, as judged by the Investigator.
Exclusion Criteria:
1. Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator. 2. Diagnosis of neurological disorders, other than MSA.
Drug: Verdiperstat, Drug: Placebo
Multiple System Atrophy, Brain and Nervous System
Multiple System Atrophy (MSA)
UT Southwestern
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Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Patients With Traumatic Brain Injury

This is a multicenter, randomized, placebo-controlled study to evaluate AVP-786 for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in participants with traumatic brain injury (TBI).
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Surendra Barshikar
168321
All
18 Years to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03095066
STU 052018-039
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Inclusion Criteria:

• Participants with traumatic brain injury (TBI)
• Participants with neurobehavioral disinhibition symptoms that are present after trauma or after recovery of consciousness
• Score of ≥4 on the modified Clinical Global Impression of Severity (mCGI-S) scale and the Agitation/Aggression or Irritability/Lability subscales of the Neuropsychiatric Inventory (NPI) scale at screening and baseline
• Participants with a reliable caregiver
Exclusion Criteria:

• Participants with significant symptoms of a major depressive disorder
• Participants with a history of or current clinical symptoms of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, or borderline personality disorder
Drug: AVP-786, Drug: Placebo
Neurobehavioral Disinhibition
aggression, agitation, irritability, non-penetrating brain injury, traumatic brain injury, TBI, AVP-786
Parkland Health & Hospital System
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Environmental Epidemiology of Essential Tremor (RULET)

This study's research is devoted to studying the causes of tremor, and especially essential tremor (ET), which is the most common type of tremor. Previous studies have revealed a link between harmane [HA], a dietary neurotoxin, and ET; these studies now also suggest a link between this toxin and Parkinson's disease (PD), a related tremor disorder. Yet these links are tentative rather than conclusively established; therefore, in this new patient-based proposal, which incorporates investigations spanning two continents (North America and Europe), utilizes several complementary study designs (prospective cohort, case control), and draws on several types of tissue (blood, brain), our goal is to nail down the links between HA and ET and to further solidify the emerging links between HA and PD.
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Elan Louis
197185
All
50 Years and over
This study is also accepting healthy volunteers
NCT04576676
STU-2020-0563
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Inclusion Criteria:

• Essential Tremor
• Subjects must be 50 years of age or older.
• Subjects must have been diagnosed with Essential Tremor
• Subjects must live within 3 hours of UTSW
• Parkinson's Disease
• Subjects must be 50 years of age or older.
• Subjects must have been diagnosed with Parkinson's Disease
• Subjects must live within 3 hours of UTSW
• Healthy Individuals
• Healthy individuals living within 3 hours of UTSW
• Subjects must be 50 years of age or older
• You are healthy and have not being diagnosed with any neurological disease
• Essential Tremor and Parkinson's Disease
• Subjects must be 50 years of age or older.
• Subjects must have been diagnosed with Essential Tremor
• Subjects must have been diagnosed with Parkinson's Disease preceded by at least 3 years of enrollment in study
• Subjects must live within 3 hours of UTSW
Exclusion Criteria:

• Healthy Individuals
• Subjects with medical history of neurological conditions
• Subjects with family history of neurological condition
• Subjects with spouse diagnosed with Essential Tremor or Parkinson's Disease
• Essential Tremor
• Subjects with medical history of another movement disorder such as Parkinson's Disease or dystonia
• Subjects with head tremor that preceded hand tremor
• Parkinson's Disease --Subjects with medical history of Essential Tremor
• Essential Tremor and Parkinson's Disease
• Criteria that does not meet inclusion
Parkinson Disease, Essential Tremor, Brain and Nervous System
UT Southwestern
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Predictors of Severe COVID-19 Outcomes (PRESCO)

This is a longitudinal, multi-center, observational study collecting diverse biological measurements and clinical and epidemiological data for the purpose of enabling a greater understanding of the onset of severe outcomes, primarily acute respiratory distress syndrome (ARDS) and/or mortality, in patients presenting to the hospital with suspicion or diagnosis of COVID-19. We seek to understand whether there are early signatures that predict progression to ARDS, mortality, and/or other comorbid conditions. The duration of the study participation is approximately 3 months.
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Mujeeb Basit
28504
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT04388813
STU-2020-0762
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Inclusion Criteria:

• Participant or legally authorized representative willing and able to provide informed consent
• Receiving care at a participating site
• Age 18 years old or older
• U.S. Resident
• Confirmed positive for COVID-19
• Willing and able to comply with all study procedures
Exclusion Criteria:

• Self reported pregnancy
Acute Respiratory Distress Syndrome, COVID-19
UT Southwestern
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Long-Term Extension Study of Inhaled Nitric Oxide (iNO) for PAH

An Open-Label Long-Term Safety Study of Inhaled Nitric Oxide (iNO) for Pulmonary Arterial Hypertension (PAH)
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Fernando Torres
45956
All
Not specified
Phase 3
This study is NOT accepting healthy volunteers
NCT02652429
STU-2019-1267
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Inclusion Criteria:

• Signed Informed Consent Form prior to the initiation of any study mandated procedures or assessments.
• PAH subjects who have completed all EOS assessments in IK-7001-PAH-201 and PULSE-PAH-004 and have continued drug/device usage.
• Subjects are willing and considered in the judgement of the Investigator able to use the INOpulse device continuously for up to 24 hours per day.
• All female subjects must be willing to continue to take adequate precaution to avoid pregnancy.
• Subjects in need for continued treatment with iNO in the opinion of the treating physician and agreement from Sponsor.
Exclusion Criteria:

• Subjects who require treatment with riociguat
• Subjects who early discontinued drug/device usage due to withdrawal of consent or an AE requiring termination from treatment in IK-7001-PAH-201
Drug: Inhaled Nitric Oxide
Pulmonary Arterial Hypertension
PAH, Pulmonary Arterial Hypertension, Inhaled Nitric Oxide, iNO
UT Southwestern
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Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy (DEVOTE)

The primary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with SMA, as measured by change in Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND) total score (Part B); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA) (Parts A and C). The secondary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A, B and C); to examine the effect of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA, to examine the effect of nusinersen administered intrathecally at higher doses compared to the currently approved dose in participants with SMA (Part B).
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Diana Castro
102470
All
Not specified
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT04089566
STU-2019-1689
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Key
Inclusion Criteria:
Part A, B and C:
•Genetic documentation of 5q SMA (homozygous gene deletion, mutation, or compound heterozygote) Part A:
• Onset of clinical signs and symptoms consistent with SMA at > 6 months (> 180 days) of age (i.e., later-onset SMA)
• Age 2 to ≤ 15 years, inclusive, at the time of informed consent Part B:
• Participants with SMA symptom onset ≤ 6 months (≤ 180 days) of age (infantile onset) should have age > 1 week to ≤ 7 months (≤ 210 days) at the time of informed consent
• Participants with SMA symptom onset > 6 months (> 180 days) of age (later onset):
• Age 2 to < 10 years at the time of informed consent
• Can sit independently but has never had the ability to walk independently
• HFMSE score ≥ 10 and ≤ 54 at Screening Part C:
•Currently on nusinersen treatment at the time of Screening, with the first dose being at least 1 year prior to Screening Part C Cohort 1:
•Participants of any age (individuals ≥18 years of age at Screening must be ambulatory) Part C Cohort 2:
• Participants ≥18 years of age at Screening (can be ambulatory or nonambulatory)
• HFMSE total score ≥4 points at Screening
• RULM entry item A score ≥3 points at Screening Key
Exclusion Criteria:
Part A, B and C:
• Presence of an untreated or inadequately treated active infection requiring systemic antiviral or antimicrobial therapy at any time during the Screening period
• Presence of an implanted shunt for the drainage of cerebrospinal fluid (CSF) or of an implanted central nervous system (CNS) catheter
• Hospitalization for surgery, pulmonary event, or nutritional support within 2 months prior to Screening or planned within 12 months after the participant's first dose Part A:
• Respiratory insufficiency, defined by the medical necessity for invasive or noninvasive ventilation for > 6 hours during a 24-hour period, at Screening
• Medical necessity for a gastric feeding tube
• Treatment with an investigational drug given for the treatment of SMA, biological agent, or device within 30 days or 5 half-lives of the agent, whichever is longer, prior to Screening or anytime during the study; any prior or current treatment with any survival motor neuron-2 (SMN2)-splicing modifier or gene therapy; or prior antisense oligonucleotide treatment, or cell transplantation Part B:
• Treatment with an investigational drug including but not limited to the treatment of SMA, biological agent, or device within 30 days or 5 half-lives of the agent, whichever is longer, prior to Screening or anytime during the study; any prior or current treatment with any SMN2-splicing modifier or gene therapy; or prior antisense oligonucleotide treatment, or cell transplantation
• Participants with SMA symptom onset > 6 months (> 180 days) of age (later onset):
• Respiratory insufficiency, defined by the medical necessity for invasive or noninvasive ventilation for > 6 hours during a 24-hour period, at Screening
• Medical necessity for a gastric feeding tube
• Participants with SMA symptom onset ≤ 6 months (≤ 180 days) of age (infantile onset): Signs or symptoms of SMA present at birth or within the first week after birth Part C:
• Concurrent or previous participation and/or administration of nusinersen in another clinical study
• Concomitant or previous administration of any SMN2-splicing modifier (excluding nusinersen) or gene therapy, either in a clinical study or as part of medical care.
• Concurrent or previous participation in any interventional investigational study for any other drug or device within 30 days or 5 half-lives of the agent, whichever is longer, prior to Screening NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Drug: Nusinersen
Muscular Atrophy, Spinal
Children’s Health
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TruGraf® Long-term Clinical Outcomes Study

This is a prospective, multi-center, observational study. Subjects will have TruGraf® and TRAC™ testing at study enrollment and thereafter every 3 months. In addition subjects will have TRAC™ testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period.
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David Wojciechowski
188709
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT04491552
STU-2020-1142
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Inclusion Criteria:

• Written informed consent and HIPAA authorization;
• At least 18 years of age;
• Recipient of a primary or subsequent deceased-donor or living-donor kidney transplant;
• At least 1-year post-transplant (+/- 2 months);
• Stable serum creatinine (current serum creatinine < 2.3 mg/dl, < 20% increase compared to the average of the previous 3 serum creatinine levels);
• Treated with any immunosuppressive regimen, and;
• Selected by provider to undergo TruGraf® and TRAC™ testing as part of post-transplant care; and
• Has Medicare Part B coverage.
Exclusion Criteria:

• Recipient of a combined organ transplant with an extra-renal organ and/or islet cell transplant;
• Recipient of a previous non-renal solid organ and/or islet cell transplant;
• Known to be pregnant;
• Known to be infected with HIV;
• Known to have BK nephropathy;
• Known to have nephrotic proteinuria (urine protein > 3 gm/day).
Diagnostic Test: Patients monitored with TruGraf and TRAC testing
Kidney Transplant Rejection
Biomarkers, Subclinical Rejection
UT Southwestern
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A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis

This study will evaulate the long-term safety, efficacy and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) administered by intravenous (IV) infusion to participants with idiopathic pulmonary fibrosis (IPF).
studyfinder@utsouthwestern.edu
All
Not specified
Phase 3
This study is NOT accepting healthy volunteers
NCT04594707
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Inclusion Criteria:

• Taken part in either of the prior PRM-151 studies: PRM-151-202 or WA42293.
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception.
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.
Exclusion Criteria:

• Acute respiratory or systemic bacterial, viral, or fungal infection at the first visit of the OLE, or within 2 weeks of the first visit for patients joining Cohort A (from Study PRM-151-202).
• History of smoking within 3 months prior to the first visit in the OLE.
• History of alcohol or substance use disorder within 2 years prior to the first visit of the OLE or known or suspected active alcohol or substance-use disorder.
• History of severe allergic reaction or anaphylactic reaction to PRM-151.
• Clinically significant abnormality on ECG during eligibility assessment including prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) based on the Fridericia correction formula; or laboratory tests (hematology, serumchemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the participant.
Drug: PRM-151
Idiopathic Pulmonary Fibrosis
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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.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Elena Ivleva
70523
All
18 Years to 75 Years old
This study is also accepting healthy volunteers
NCT04951700
STU-2021-0413
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Inclusion Criteria:

• 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.)
Other: Other
Schizophrenia, Aging, Disease Course, Biomarker, Neuroimaging, Cognitive Dysfunction
UT Southwestern
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A Study of Real-world Cohort of Pulmonary Arterial Hypertension (PAH) Participants (CARE PAH)

studyfinder@utsouthwestern.edu
All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT04955990
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Inclusion Criteria:

• Clinically diagnosed pulmonary arterial hypertension (PAH) in any PAH subtype
• Hemodynamic evaluation at rest at any time prior to or at the index date fulfilling all of the criteria below: a) Mean pulmonary artery pressure greater than (>) 20 millimeters of mercury (mmHg), and b) Pulmonary artery wedge pressure or left ventricular end diastolic pressure less than or equal to (<=) 15 mmHg, and c) Pulmonary vascular resistance greater than or equal to (>=) 3 Wood Units (that is, >= 240 dynes seconds per centimeters penta [dyn∙sec/cm^5])
• Newly initiating 1 or more PAH therapy(ies) at index date
• All mandated assessments must be performed and recorded at the baseline visit before the initiation of the new PAH therapy at the index date
• For the pulmonary arterial hypertension-symptoms and impact (PAH-SYMPACT) substudy only: Participants initiating any endothelin receptor antagonist (ERA) or phosphodiesterase-5 inhibitor therapies at index date or at therapy change must provide consent to enroll in the optional PAH-SYMPACT substudy. Refusal to give consent for the optional PAH-SYMPACT substudy will not exclude a participant from participation in the main study
Exclusion Criteria:

• Participants enrolled in any interventional clinical trial with an investigational therapy in the 3-month period prior to index date
• Any PAH therapy initiated at index date was used by the participant (including different route of administration of the same compound) within 3 months prior to index date for any reason. (Administration for vasoreactivity testing is permitted)
Drug: PAH Therapies
Pulmonary Arterial Hypertension
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Study to Evaluate t(11;14) Status and BCL2 Expression in Adult Participants With Multiple Myeloma (MM) (MEDICI)

studyfinder@utsouthwestern.edu
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT04721002
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Inclusion Criteria:

•Confirmed newly diagnosed or relapsed/refractory (R/R) Multiple myeloma (MM) who have signed informed consent for the use of their biological material for research purposes.
Exclusion Criteria:

•Participants who do not have Bone Marrow (BM) and blood sample at time of diagnosis or at confirmation of relapse.
Multiple Myeloma (MM)
Multiple myeloma (MM), Relapsed/Refractory (R/R) Multiple myeloma (MM), t(11, 14), BCL2
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Potential Benefits of Laser Treatment on Skin Blood Flow and Sweating in Burn Survivors

studyfinder@utsouthwestern.edu
All
18 Years to 65 Years old
This study is NOT accepting healthy volunteers
NCT04947449
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Inclusion Criteria:

• 18-65 years old
• Experience a severe burn injury that warrant laser therapy.
• Free of any significant underlying medical problems based upon a detailed medical history and physical exam
Exclusion Criteria:

• Known heart disease
• Other chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, and uncontrolled hypercholesterolemia.
• Abnormality detected on routine screening suggestive of cardiac ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram.
• Subject with a body mass index >35 kg/m2
• Pregnant or planning to become pregnant within the subsequent 6 months.
Device: fractional CO2 laser
Burn Injury
laser treatment, laser therapy, skin blood flow, sweating
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Phase III Study of Trifluridine/Tipiracil in Combination With Bevacizumab vs Trifluridine/Tipiracil Single Agent in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT)

studyfinder@utsouthwestern.edu
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04737187
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Inclusion Criteria:
1. Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded). 2. RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy. 3. Has received a maximum of 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer and had demonstrated progressive disease or intolerance to their last regimen. 4. Has measurable or non-measurable disease as defined by RECIST version 1.1 5. Is able to swallow oral tablets. 6. Estimated life expectancy ≥12 weeks. 7. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
Exclusion Criteria:
1. More than 2 prior chemotherapy regimens for the treatment of advanced colorectal cancer. 2. Pregnancy, lactating female or possibility of becoming pregnant during the study. 3. Patients currently receiving or having received anticancer therapies within 4 weeks prior to randomization. 4. Has not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to randomization (excluding alopecia, and skin pigmentation). 5. Has symptomatic central nervous system metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease. 6. Has severe or uncontrolled active acute or chronic infection. 7. Has active or history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension. 8. Known Hepatitis B or Hepatitis C Virus infection. 9. Known carriers of HIV antibodies. 10. Confirmed uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg) or uncontrolled or symptomatic arrhythmia. 11. Deep arterial thromboembolic events including cerebrovascular accident or myocardial infarction within the last 6 months prior to randomization. 12. Treatment with any of the following within the specified time frame prior to randomization:
• major surgery within 4 weeks prior to randomisation (the surgical incision should be fully healed prior to study drug administration), or has not recovered from side effects of previous surgery, or patient that may require major surgery during the study
• Prior radiotherapy if completed less than 4 weeks before randomisation, except if provided as a short course for symptoms palliation only.
• Drainage for ascites, pleural effusion or pericardial fluid within 4 weeks prior to randomization 13. Other clinically significant medical conditions. 14. Other malignancies.
Drug: Trifluridine/Tipiracil, Drug: Bevacizumab
Refractory Metastatic Colorectal Cancer
trifluridine/tipiracil, TAS102, bevacizumab, avastin, RAS status (wild type, mutant)
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Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants & Young Children (BEGIN)

Call 214-648-5005
studyfinder@utsouthwestern.edu
Meghana Sathe
68730
All
up to 5 Years old
This study is NOT accepting healthy volunteers
NCT04509050
STU-2020-0752
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Inclusion Criteria:

• Part A:
• Less than 5 years of age at the first study visit.
• Documentation of a CF diagnosis. Part B:
• Participated in Part A OR less than 6 years of age at the first study visit.
• Documentation of a CF diagnosis.
• CFTR mutations consistent with FDA labeled indication of highly effective modulator therapy (ivacaftor or elexacaftor/tezacaftor/ivacaftor).
• Physician intent to prescribe ivacaftor or elexacaftor/tezacaftor/ivacaftor.
Exclusion Criteria:

• Part A and Part B: Use of an investigational drug within 28 days prior to and including the first study visit. Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor within the 180 days prior to and including the first study visit. Use of chronic oral corticosteroids within the 28 days prior to and including the first study visit.
Drug: Ivacaftor or elexacaftor/tezacaftor/ivacaftor
Cystic Fibrosis, Other Digestive Organ
Cystic Fibrosis, CF, CFTR Modulator, triple combination therapy, elexacaftor, tezacaftor, ivacaftor
Children’s Health
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Trial of Parkinson's And Zoledronic Acid (TOPAZ)

studyfinder@utsouthwestern.edu
All
60 Years and over
Phase 4
This study is also accepting healthy volunteers
NCT03924414
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Inclusion Criteria:

• Men and women age 60 years or older
• Current Parkinson's Disease diagnosis or neurodegenerative parkinsonism diagnosis (including progressive supranuclear palsy, multiple system atrophy, cortical basal degeneration, vascular parkinsonism, dementia with Lewy bodies or another form of neurodegenerative parkinsonism) based on an expert assessment (neurologist diagnosis via medical records confirmation or Telemedicine Screening Assessment)
• Willing and able to continue in follow-up for at least 2 years
• Willing and able to provide informed consent
Exclusion Criteria:

• History of hip fracture
• Any use of a bisphosphonate drug within the last 12 months
• Use of any other osteoporosis treatment (such as SERMs and denosumab) within the last 6 months
• Tooth extraction or invasive dental procedures within the past 30 days or planned/scheduled extraction/procedure in the next 12 months
• Non-ambulatory, i.e., unable to walk without assistance of another person.
• Undergoing kidney dialysis
• A diagnosis of multiple myeloma or Paget's disease
• Unable to speak or read English sufficiently to complete informed consent
• Any other criteria, which would make the patient unsuitable to participate in this study as determined by the study staff (e.g., an uncontrolled drug and/or alcohol addiction)
Drug: Zoledronic Acid 5Mg/Bag 100Ml Inj, Other: Placebo
Progressive Supranuclear Palsy, Multiple System Atrophy, Parkinson Disease, Parkinsonism, Osteoporosis, Parkinson's Disease and Parkinsonism, Atypical Parkinsonism, Vascular Parkinsonism, Dementia With Lewy Bodies
Parkinson Disease, Parkinson's Disease, Osteoporosis, Zoledronic acid, Neurology, Bone, Fracture, Parkinsonism, Atypical Parkinsonism, Progressive Supranuclear Palsy, Multiple System Atrophy, Vascular Parkinsonism, Dementia with Lewy Bodies
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