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852 Study Matches

Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease (IPSG1)

Legg-Calvé-Perthes disease is a childhood hip disorder which is common enough to be a significant public health problem (affects 1 in 740 boys between ages 0—14), but uncommon enough to have a sufficient number of patients from a single institution to perform a definitive prospective study comparing the results of current treatments. The present study will establish a database of prospectively identified patients with Legg-Calvé-Perthes (LCP) Disease and collect information regarding their presentation, treatment, and outcomes in the course of receiving currently available treatments. This study seeks to compare the outcomes of current treatments in the management of different age groups (ages 1-6, 6—8, 8—11, >11) of patients with Perthes disease at two- and five-year followup and at skeletal maturity. For each age group, two to three common treatment regimens currently used by practicing pediatric orthopaedic surgeons will be compared. The intervention a patient receives is determined through physician preference. Physicians pick an intervention for each age group and treat each patient with the same intervention.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Harry Kim
110034
All
6 Years to 16 Years old
This study is NOT accepting healthy volunteers
NCT02040714
STU 082012-052
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Inclusion Criteria:

• Diagnosed with Legg-Calvé-Perthes disease
• Between age 1-18
• Patients with possible secondary femoral osteonecrosis if over the age of 11 due to trauma or corticosteroid therapy are also eligible.
Exclusion Criteria:

• Patients with previous surgical treatment on the affected hip if not in the >11 age group
Procedure: osteotomy, Procedure: multiple epiphyseal drilling
Legg Calve Perthes Disease, Bones and Joints
femur head necrosis, hip, pediatric orthopedics, MRI, Osteonecrosis, Bone diseases, Legg Calve Perthes Syndrome
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G551D Observational Study- Expanded to Additional Genotypes and Extended for Long Therm Follow up (GOAL-e2) (GOAL- e2)

The goal of this research study is to collect blood and urine samples from people who have either the R117H type of CF or the non-G551D gating type of CF to be kept for future research.We will also use some of the collected blood to measure the number of neutrophils.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Raksha Jain
19733
All
6 Years and over
This study is NOT accepting healthy volunteers
NCT01521338
STU 102011-029
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Inclusion Criteria for Core Study: 1. Male or female ≥ 6 years of age at Visit 1. : 2. Must have a clinical diagnosis of cystic fibrosis and the following CFTR mutations: 1. For Cohort 1 (Closed to enrollment June 30, 2012): G551D on at least 1 allele Any known or unknown mutations allowed on second allele. 2. For Cohort 2: R117H on at least 1 allele Any known or unknown mutation on the second allele except G551D 3. For Cohort 3: A Non-G551D gating mutation on one allele: (G178R, S549N, S549R, G551S,G970R, G1244E, S1251N, S1255P, G1349D) Any known or unknown mutation on the second allele except G551D OR R117H 3. Enrolled in the Cystic Fibrosis Foundation Patient Registry (with the exception of Canadian sites). (Patients may enroll in the Registry at Visit 1 if not previously enrolled.) 4. Clinically stable with no significant changes in health status within the 14 days prior to Visit 1. 5. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative. Exclusion Criteria for Core Study 1. Participation in the VX-770-105, VX-770-106, VX-770-108, VX-770-110, VX-770-111, VX-770-112, or VX-770-113 study, VX-770 Extended Access Program or use of ivacaftor within 6 months prior to Visit 1. 2. Any upper or lower respiratory symptoms requiring treatment with oral, inhaled or IV antibiotics within the 2 weeks prior to Visit 1. 3. History of solid organ transplantation. 4. Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
Cystic Fibrosis
Cystic Fibrosis, G551D, G551D Mutation
Children’s Health
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Healthy Sleep for Children With Down Syndrome (HELP-DS)

The purpose of this multi-center observational study (utilizing the sites enrolling patients for the Pediatric Adenotonsillectomy Trial for Snoring (PATS) [1U011HL125307-O1A1]) is to gather data regarding children with Down syndrome (DS) and Sleep Disordered Breathing (SDB) referred for treatment with adenotonsillectomy to inform a future randomized controlled trial in this population.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Ron Mitchell
124198
All
3 Years to 13 Years old
This study is NOT accepting healthy volunteers
NCT03922165
STU-2019-0645
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Inclusion Criteria:

• DS diagnosis regardless of genetic status (e.g., mosaicism or translocation).
• Aged >3 to <13 years at the date of consent.
• Primary indication for AT is nocturnal obstructive symptoms (i.e., not recurrent infections or other indications).
• Deemed to be a candidate for AT by Ear, Nose and Throat (ENT) evaluation; that is, no technical issues that would be a contraindication for surgery such as submucous cleft palate.
Exclusion Criteria:

• Prior tonsillectomy (partial or complete).
• Severe chronic health conditions that would contradict surgery (severe morbid obesity, unrepaired cyanotic congenital heart disease, bleeding disorders).
• Severe behavioral problems that would preclude participation in the study's testing procedures (PSG, actigraphy).
• Severe OSA with respiratory failure needing urgent/emergent management
• Plan to undergo additional airway surgery at the time of AT.
• Caregiver/child planning to move out of the area within 6 months.
• Caregiver/child does not speak English or Spanish well enough to complete the behavioral and performance measures.
• Child in foster care.
Procedure: Adenotonsillectomy
Down Syndrome, Sleep Disordered Breathing
Pediatrics, Adenotonsillectomy
Children’s Health
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Alcoholic Hepatitis Network Observational Study

The purpose of this research study is to create a clinical database and bio-repository. To do this, we will obtain blood, urine, and stool samples (e.g., biological samples) and personal health information from you to use in future research studies related to alcoholic hepatitis or other diseases. Part of your blood sample will be used to extract your DNA. DNA is the genetic material that gives us unique characteristics. We are doing this research study because we are trying to find out more about how and why illnesses related to alcoholic hepatitis or other diseases occur in people. To do this, we will study the biological samples and personal health information from healthy and sick people. A "biological sample" is usually blood, but can be any body fluid. "Personal Health Information" includes such items as your name, age, gender, race, and/or your medical information. It can also include data from measurements and tests that you had while participating in another research study or that were done during the course of your regular medical care or doctor visits.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Mack Mitchell
124226
All
21 Years and over
This study is also accepting healthy volunteers
NCT03850899
STU-2019-0472
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CASES: Heavy drinkers with alcoholic hepatitis Inclusion criteria 1. A clinical diagnosis of alcoholic hepatitis 2. Serum total bilirubin >3 mg/dL 3. Subject or guardian ability to understand and willingness to provide written consent 4. Age greater or equal to 21 years 5. Re-enrolment of an alcoholic hepatitis donor is permissible up to 4 times if the donor presents with a new episode of alcoholic hepatitis 24 weeks or longer after the most recent enrolment in the study Exclusion criteria 1. Liver disease significantly caused by hemochromatosis, autoimmune liver disease, Wilson disease, NAFLD, and acute viral hepatitis 2. (NOTE: The presence of chronic hepatitis C, hepatitis B, or HIV is not exclusion to participation.)Pregnant or breast feeding Based on the judgment of the investigator, subject is not capable of understanding or complying with the study requirements. CONTROLS: Heavy drinkers without significant liver disease Inclusion criteria 1. History of chronic alcohol consumption sufficient to cause liver damage. Generally, this is considered to be >40 g/day or >280g/week on average for women and >60 g/day or >420 g/week on average for men, for many years (usually decades). Judgement about chronic alcohol consumption will be made by the site investigator. 2. Subject or guardian ability to understand and willingness to provide written consent 3. Age greater or equal to 21 years Exclusion criteria 1. Past evidence of alcoholic liver disease, defined as a bilirubin > 2.0 mg/dL, an AST > 1.5 ULN, and any hospital admission for liver disease, or the presence of esophageal varices or ascites (at any time in the past). 2. Liver disease significantly caused by hemochromatosis, autoimmune liver disease, Wilson disease, NAFLD, and acute viral hepatitis (NOTE: The presence of chronic hepatitis C, hepatitis B, or HIV is not exclusion to participation.) 3. Alcohol intake at less than 40 g/day or 280g/week on average for women and 60 g/day or 420 g/week on average for men for longer than the past 28 days 4. If liver stiffness has been assessed within the prior 90 days, then stiffness suggesting fibrosis of F1 or greater is excluded. For Fibroscan, this is a fibrosis score >7.0 kPa. 5. Pregnant or breast feeding 6. Any of the following laboratory abnormalities within 90 days prior to signing the consent. 1. Total bilirubin: >ULN* 2. INR: > 1.4 5 *Individuals with a diagnosis of Gilbert's can have total bilirubin up to 3.0 mg/dL and still be eligible for participation. Healthy Controls Inclusion criteria 1. AUDIT-C scores of <4 for men and <3 for women (signifying no alcohol misuse) 2. Abstinent (consumption of less than one standard drink/week) during the 6 months prior to enrolment 3. Ability to understand and willingness to provide written consent. Exclusion criteria 1. Clinical history or laboratory evidence of liver disease including alcoholic liver disease, NAFLD, hemochromatosis, alcoholic hepatitis, autoimmune liver disease, Wilson disease, hepatitis C, or hepatitis B. 2. Presence of diabetes (requiring treatment with oral agents or insulin). 3. Significant heart disease (prior history of heart disease, other than hypertension) 4. Chronic lung disease (requiring chronic treatment) 5. Immune related conditions (such as Crohn's disease, rheumatoid arthritis, ulcerative colitis, systemic lupus erythematosus, severe psoriasis, etc.) 6. Known infection with HIV 7. Presumed infection, or use of antibiotics or other medications (e.g., corticosteroids) that would affect immune function, within the past 14 days 8. BMI>35 9. Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment 10. Pregnant or breast feeding 11. Any of the following laboratory abnormalities within 90 days prior to signing the consent. 1. Hemoglobin: <10 g/dL 2. Conjugated bilirubin: > ULN 3. INR: > 1.4 4. AST: >40 IU/mL 5. ALT: >40 IU/mL 12. Based on the judgment of the investigator, subject is not capable of complying with the study requirements
Alcoholic Hepatitis, Liver
Parkland Health & Hospital System
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Red Blood Cell Exchange Transfusion as a Novel Treatment for GLUT1 Deficiency Syndrome

This proposal is an investigator-initiated, single-site proof of concept trial. Five patients will undergo isovolemic hemodilution-red cell exchange (IHD- RBCx) with up to 10 units of red cell antigens (Rh group, Kell, Duffy, Kidd blood group antigens) matched normal donor red cells to replace a target of 70% of the patient's red cells with donor red cells. The procedure will be performed as an outpatient according to protocols established for sickle cell anemia patients. One of the investigators is an expert on RBCx and will oversee the transfusion. Subjects will be assessed before and after transfusion, and at two months post transfusion. Outcome measures include neurological exam, electroencephalography (EEG), neuropsychological testing, and biochemical assays.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Juan Pascual
85158
All
16 Years to 64 Years old
Early Phase 1
This study is NOT accepting healthy volunteers
NCT04137692
STU 122014-010
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Inclusion Criteria:

• Male or Female
• Age 16 years to 64 years old.
• Diagnosed with genetically-confirmed glucose transporter type 1 disorder
• Patients not currently receiving dietary therapy, including ketogenic diet or other dietary therapy, due to failure of these diets to achieve seizure remission or due to patient preference, including compliance or tolerance issues. Patients currently on Modified Atkins Diet (MAD) and / or taking Medium Chain Triglyceride (MCT) oil are allowed.
Exclusion Criteria:

• Currently on the ketogenic diet or taking triheptanoin (C7) oil
• No genetic confirmation of G1D diagnosis
• Unable to return for follow up visits
• Weak peripheral veins, such that IV placement is contraindicated (required for transfusion)
• Serious chronic medical conditions, such as congestive heart failure, renal failure, liver failure, or any other medical conditions that preclude large volume transfusions.
• Patients currently pregnant or breast-feeding are excluded from participating in this research. Patients who plan on getting pregnant during this research or who are unwilling to use birth control, including abstinence, during the course of this research are also excluded due to safety concerns for the fetus.
Other: Red Blood Cell Transfusion
Glucose Transporter Type 1 Deficiency Syndrome, GLUT1DS1, Brain and Nervous System, Other Hematopoietic
G1D, Glucose transporter
Children’s Health
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Sling vs Botox for Mixed Incontinence (MUSA)

The primary aim is to compare the effectiveness of intradetrusor injection of 100 unit injection of Botulinum toxin A to mid-urethral sling for change in MUI symptoms 6 months following treatment.
Research Coordinator: Agnes Burris, RN: 214-645-3833, Agnes.Burris@utsouthwestern.edu
Research Assistant: Ms. Juanita Bonilla: 214-648-2507, Juanita.Bonilla@utsouthwestern.edu
or
Call 214-648-5005
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David Rahn
49553
Female
21 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04171531
STU-2019-1731
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Inclusion Criteria:
1. Reporting at least "moderate bother" from UUI item on UDI * "Do you experience urine leakage associated with a feeling of urgency?" 2. Reporting at least "moderate bother" from SUI item on UDI * "Do you experience urine leakage related to physical activity, coughing, or sneezing?" 3. Diagnosis of SUI defined by a positive cough stress test (CST) or UDE within the past 18 months 4. Presence of UUI on bladder diary with > 4 Urgency IE/3-day diary 5. Urinary symptoms >3 months 6. Persistent symptoms despite at least one or more conservative treatments (e.g. supervised behavioral therapy, physical therapy) as determined adequate by the physician. 7. Inadequate response to oral overactive bladder medications (including anti-cholinergic and/or beta-mimetic medication) unless patient is 1. intolerant of oral overactive bladder medications, or 2. oral overactive bladder medications are contraindicated as determined by the treating provider. 8. Urodynamics within past 18 months 9. Demonstrates ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization.
Exclusion Criteria:
1. Anterior or apical compartment prolapse at or beyond the hymen (>0 on POPQ), regardless if patient is symptomatic * Women with anterior or apical prolapse above the hymen (<0) who do not report vaginal bulge symptoms will be eligible 2. Planned concomitant surgery for anterior vaginal wall or apical prolapse > 0 * Women undergoing only rectocele repair or other repair unrelated to anterior or apical compartment are eligible 3. Women undergoing hysterectomy for any indication will be excluded 4. Active pelvic organ malignancy 5. Age <21 years 6. Pregnant or plans for future pregnancy in next 6 months, or within 12 months post-partum 7. Post-void residual >150 cc on 2 occasions within the past 6 months, or current catheter use 8. Participation in other trial that may influence results of this study 9. Unevaluated hematuria 10. Prior sling, synthetic mesh for prolapse, implanted nerve stimulator for urinary incontinence 11. Spinal cord injury or advanced/severe neurologic conditions including Multiple Sclerosis, Parkinsons, Myasthenia Gravis, Charcot-Marie-Tooth 12. Women on overactive bladder medication/therapy will be eligible after 3 week wash-out period 13. Non-ambulatory 14. History of serious adverse reaction to synthetic mesh 15. Not able to complete study assessments per clinician judgment, or not available for 6 month follow-up 16. Diagnosis of and/or history of bladder pain or chronic pelvic pain 17. Women who had intravesical Botox injection within the past 12 months 18. Women who have undergone anterior or apical pelvic organ prolapse repair within the past 6 months
Drug: Botox® injection, Device: Mid-urethral sling
Urinary Incontinence, Urge, Urinary Incontinence, Stress, Urinary Bladder
urinary incontinence, midurethral sling, Botulinum toxin A (Botox A ®)
Parkland Health & Hospital System
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Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis (RAISE)

The RAISE study is a multicenter, randomized, double-blind, placebo controlled study to confirm the efficacy, safety, and tolerability of zilucoplan in subjects with generalized Myasthenia Gravis. Subjects will be randomized in a 1:1 ratio to receive daily SC doses of 0.3 mg/kg zilucoplan or placebo for 12 weeks.
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Shaida Khan
137363
All
18 Years to 75 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT04115293
STU-2019-1157
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Inclusion Criteria:

• Diagnosis of gMG [Myasthenia Gravis Foundation of America (MGFA) Class II-IV] at Screening
• Positive serology for acetylcholine receptor (AChR) autoantibodies
• MG-ADL Score of ≥ 6 at Screening and Baseline
• QMG score ≥ 12 at Screening and Baseline
• No change in corticosteroid dose for at least 30 days prior to Baseline or anticipated to occur during the 12-week Treatment Period
• No change in immunosuppressive therapy, including dose, for at least 30 days prior to Baseline or anticipated to occur during the 12-week Treatment Period
Exclusion Criteria:

• Thymectomy within 12 months prior to Baseline or scheduled to occur during the 12 week Treatment Period
• History of meningococcal disease
• Current or recent systemic infection within 2 weeks prior to Baseline or injection requiring intravenous (IV) antibiotics within 4 weeks prior to Baseline
Drug: zilucoplan (RA101495), Drug: Placebo
Myasthenia Gravis, Generalized
UT Southwestern
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Cryopreserved vs. Lyopreserved Stravix as an Adjunct to NPWT in the Treatment of Complex Wounds

This study is a prospective, 2-arm parallel assignment, randomized clinical trial to compare lyopreserved vs cryopreserved Stravix as an adjunct therapy to NPWT.
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Lawrence Lavery
116716
All
21 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT04405765
STU-2020-0293
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Inclusion Criteria:

• Diagnosis of a diabetes mellitus
• Men/women ≥21 years old
• Post-operative foot or ankle wounds sized >4cm2 that have presented for <1 year
• ABI ≥0.5 or toe pressures >30 mmHg
• Wounds indicated for treatment with NPWT
Exclusion Criteria:

• Active Charcot arthropy
• Unable to use NPWT at home
• Untreated bone or soft tissue infection
• Is pregnant or plans to become pregnant
• Is nursing or actively lactating
• Developmental disability/significant psychological disorder that in the opinion of the investigator could impair the subject's ability to provide informed consent, participate in the study protocol or record study measures, including untreated schizophrenia, bipolar disorder and psychiatric hospitalization within the last 2 years.
• Active alcohol or substance abuse in the opinion of the investigator that could impair the subject's ability to provide informed consent, participate in the study protocol or record study materials
Device: NPWT and lyopreserved Stravix, Device: NPWT and cryopreserved Stravix
Diabetic Wound
Parkland Health & Hospital System
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Silent Cerebral Infarct Transfusion Multi-Center Clinical Trial (SIT)

The goal of this study is to determine the effectiveness of blood transfusion therapy for prevention of silent cerebral infarct (stroke) in children with sickle cell anemia.
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Patrick Leavey
35610
All
5 Years to 14 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT00072761
Study00000074
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INCLUSION:
• Patient must have sickle cell anemia (hemoglobin SS) or sickle beta thalassemia (hemoglobin SB) as confirmed at the local institution.
• Participating institutions must submit documentation of the diagnostic hemoglobin analysis to the Statistical and Clinical Coordinating Centers to confirm the diagnosis of sickle cell anemia prior to randomization.
• Patient must be 5 through 14 years of age.
• Patient must have a cerebral infarct documented by MRI scan as read by the neuroradiology panel.
• Informed consent with assent in accordance with the institutional policies (institutional Institutional Review Board approval) and Federal guidelines (approved by the United States Department of Health and Human Services) must be signed by the patient's legally authorized guardian acknowledging written consent to join the study. When suitable, patients will be requested to give their assent to join the study. EXCLUSION:
• Patient with a history of a focal neurologic event lasting more than 24 hours with medical documentation or a history of prior overt stroke.
• Patients with a transcranial doppler (TCD) study with a time-averaged mean velocity greater than 200 cm/sec verified by the study radiologist.
• Patients with other neurological problems, such as neurofibromatosis, lead poisoning, or tuberous sclerosis.
• Patients with HIV infection.
• Pregnancy.
• Patients who received treatment with anti-sickling drugs or hydroxyurea within 3 months or anticipate receiving anti-sickling drugs or hydroxyurea during the course of the study.
• Abnormal kidney function (creatinine > 2x upper limit of normal).
• Patients on chronic blood transfusion therapy for other reasons.
• Patients judged not likely to be compliant by his/her hematologist and local nurse coordinator based on previous compliance in clinic appointments and following advice. Specifically, families that have missed at least two appointments without notification within 12 months prior to the trial or parents of potential patients that have been reported for medical or education neglect are not eligible for this trial.
• Patients unable to receive blood transfusion because of alloimmunization.
• Patients with permanent or semi-permanent metallic (braces on teeth) structures attached to their body. Such patients cannot obtain a MRI of the head to assess the presence of silent cerebral infarcts.
• Siblings randomized in the trial.
Procedure: transfusion therapy
Stroke, Sickle Cell Anemia
silent cerebral infarct, silent stroke, sickle cell anemia, stroke, transfusion therapy
Children’s Health
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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 must have the patient volume to be able to recruit up to 500 patients over the course of 14 months, and they will be required to work closely with 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).
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Madhukar Trivedi
17410
All
8 Years to 20 Years old
This study is NOT accepting healthy volunteers
NCT04572321
STU-2020-0665
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Inclusion Criteria:
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).
Depression, Suicidal Ideation, Suicide, Attempted, Depressive Disorder, Suicide, Depressive Episode, Depressive Symptoms, Depression and Suicide, Depression, Teen, Depression, Anxiety
depression, suicide, suicidal ideation, suicide attempt, teen, child, depressive episode, depression in teens
Children’s Health
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Motor Outcomes to Validate Evaluations in FSHD (MOVE FSHD) (MOVE FSHD)

The primary goal of this proposal is to collect motor and functional outcomes specific to FSHD over time. By collecting measures specific to FSHD, this will help ensure the best level of clinical care is being provided. Also, the hope is to speed up drug development by gaining a better understanding of how having FSHD impacts motor function and other health outcomes (i.e. breathing, wheelchair use, etc.) and how big a change in motor function would be clinically meaningful to those with FSHD.
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Jaya Trivedi
46764
All
Not specified
This study is NOT accepting healthy volunteers
NCT04635891
STU-2020-0726
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Inclusion Criteria:

• Genetically confirmed FSHD (types 1 or 2) or clinical diagnosis of FSHD with characteristic findings on exam and an affected parent or offspring.
Exclusion Criteria:

• Unwilling or unable to provide informed consent.
• Any other medical condition which in the opinion of the investigator would interfere with study participation.
FSHD
UT Southwestern
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FUVID Study: Functional Characterization of Children With Chronic Venous Thromboembolic Disease

This is a multi-center prospective cohort study of patients with first-episode deep venous thrombosis and pulmonary embolism.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Ayesha Zia
149180
All
8 Years to 21 Years old
This study is NOT accepting healthy volunteers
NCT04583878
STU-2020-0868
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Inclusion Criteria:

• Ages 8 to ≤ 21 years
• Participant must be able to speak and understand English
• Be willing to participate and able to comply with the study protocol
• For participants with PE: Children with acute, radiologically confirmed pulmonary embolism (PE) with our without DVT
• For control group: Children who are prescribed physical activity restrictions for 4 up to 12 weeks following any minor outpatient surgery or, minor injury (surgery or injury is referred to as "diagnosis" hereafter)
Exclusion Criteria:

• Congenital heart disease with abnormal pulmonary circulation or with in-situ pulmonary artery thrombosis
• Chronic kidney disease
• Chronic inflammatory or an autoimmune disorder (such as systemic lupus erythematosus, juvenile rheumatoid disorder, inflammatory bowel disease, and sickle cell disease)
• A metabolic or endocrinological disorder such as diabetes mellitus or thyroid disorder
• History of or active cancer
• Pregnant
• Musculoskeletal limitations to exercise expected to be present uptil 4 months post-diagnosis
• Weight ≥ 300 lbs
• Contraindications to magnetic resonance imaging
• Frequent severe exacerbations of asthma defined by two or more bursts of systemic glucocorticoids (more than three days each) in the previous year or at least one hospitalization, intensive care unit stay or mechanical ventilation in the previous year. Patients should also be excluded if there are daily symptoms of asthma requiring daily use of short-acting bronchodilators such as albuterol or levalbuterol administration. The use of controller medications such as daily inhaled corticosteroids for mild persistent asthma is not exclusionary.
• Has any other medical condition, which in the opinion of the investigator may potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical study Additional exclusion criteria for participants with PE:
• Prior history of DVT or PE (upper extremity, cerebral sinus venous thrombosis and abdominal thromboses encountered as a neonate are not exclusion criteria)
• Lack of anticoagulant treatment for the acute VTE due to contraindications
Diagnostic Test: Blood draw (Visit 1), Diagnostic Test: Blood draw (Visits 2 and 3)
Pulmonary Embolism, Deep Venous Thrombosis, Cardiovascular, Lung/Thoracic
Parkland Health & Hospital System
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Natural History Clinical Study in Adult PKU

The objective of this study is to characterize the natural history of phenylketonuria (PKU) due to phenylalanine hydroxylase (PAH) deficiency in adults through prospective collection of clinical, cognitive, and quality of life assessments.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Markey McNutt
59152
All
18 Years to 55 Years old
This study is NOT accepting healthy volunteers
NCT04768348
STU-2020-1380
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Key
Inclusion Criteria:

• Aged 18-55 years at the time of informed consent
• Diagnosis of PKU due to PAH deficiency
• One plasma Phe value with a concentration of ≥ 600 μmol/L drawn at Screening and at least 1 historical Phe value ≥ 600 μmol/L in the preceding 12 months Key
Exclusion Criteria:

• Subjects with PKU that is not due to PAH deficiency
• Alanine aminotransferase (ALT) > 1.5x upper limit of normal (ULN) and aspartate aminotransferase (AST) >1.5x ULN
• Alkaline phosphatase > 1.5x ULN
• Total bilirubin > 1.5x ULN, direct bilirubin ≥ 1.5x ULN, unless associated with Gilbert's syndrome.
• Serum creatinine > 1.5x ULN
• Hematology values outside of the normal range (hemoglobin < 11.0 g/dL for males or < 10.0 g/dL for females; white blood cells (WBC) < 3,000/μL; absolute neutrophils < 1,500/μL; platelets < 100,000/μL)
• Hemoglobin A1c > 6.5% or fasting glucose > 126 mg/dL
• Any clinically significant abnormal laboratory result at Screening, as determined by the Investigator
Other Endocrine System, Phenylketonurias, PKU
UT Southwestern
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Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair (TT TEF)

This trial will compare the effectiveness of two common surgical practices for Type C esophageal atresia repair: esophageal atresia (EA) with distal tracheoesophageal fistula (TEF). Infants with EA/TEF requiring surgical intervention will be recruited. Subjects will be randomized to either repair with or without transanstomotic tube (TT) during esophageal anastomosis creation. Primary outcome is symptomatic anastomotic stricture development requiring dilation within 12 months.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Samir Pandya
177098
All
up to 6 Months old
Phase 4
This study is NOT accepting healthy volunteers
NCT03730454
STU-2020-1118
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Inclusion Criteria:

• Infants diagnosed with type C esophageal atresia: proximal esophageal atresia and distal tracheoesophageal fistula
• Primary repair of the esophageal atresia within the first six months of life
• Minimum follow up of 1 year (12 months)
Exclusion Criteria:

• Other types of esophageal atresia without esophageal anastomosis creation
• Major anomaly that influences likelihood of developing primary outcome or affects surgical treatment considerations
Device: Transanastomotic Tube (5FR), Other: No Transanastomotic Tube
Esophageal Atresia, Esophagus, Tracheoesophageal Fistula
Children’s Health
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Alcohol Induced de Novo Lipogenesis in Women

The study is cross-sectional is design. In the first Aim of this study, 5 women and 5 men will be asked to consume 2g/kg of [2H]water (a.k.a. deuterium oxide or heavy water) which incorporates 2H tracers into newly synthesized fatty acids and triglycerides. Deuterated water is not radioactive and has a long history of application in human studies. Researchers will collect blood samples 2 hours before and 5 hours after the participants consume 20 grams of alcohol as vodka to measure alcohol induced hepatic de novo lipogenesis (DNL) in both men in women. In addition, for Aim 2 researchers will recruit an additional 10 women who will be randomized into one of two groups who will consume a beverage containing vodka and sucrose, or sucrose alone. Aim 2 will be identical to the experimental scheme in Aim 2 in order to determine if sucrose enhances the effects of vodka on hepatic DNL.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Justin Fletcher
157755
All
21 Years to 45 Years old
N/A
This study is also accepting healthy volunteers
NCT04829110
STU-2021-0246
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Inclusion Criteria:

• Male or Female
• Ages 21
•45
• Healthy
• Light to moderate alcohol consumption (≤1 drink a day (~14g) in women and ≤2 drinks a day (~28 g) in men)
• BMI between 18.5-29.9
• Normal Nutritional Status
• Ability to speak and understand English
Exclusion Criteria:

• BMI >29.9
• Comorbid conditions
• Any regular medications, except Oral Contraceptives
• Pregnant or Breastfeeding
• Regular exercise above activities of daily living
Other: ETOH, Other: Sucrose
Liver Metabolism
UT Southwestern
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A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG).
studyfinder@utsouthwestern.edu
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04951622
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Inclusion Criteria:

• Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II a/b, III a/b, or IVa/b at screening
• Myasthenia Gravis
•Activities of Daily Living (MG-ADL) score of greater than or equal to (>=) 6 at screening and baseline
• Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol
• A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention
• A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last administration of study intervention
Exclusion Criteria:

• Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her gMG, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
• Has MGFA Class I disease or presence of MG crisis (MGFA Class V) at screening, history of MG crisis within 1 month of screening, or fixed weakness (and/or 'burnt out' MG)
• Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the study
• Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
• Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening
Drug: Nipocalimab, Drug: Placebo
Myasthenia Gravis
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Behavioral Activation Teletherapy to Increase Physical Activity (BAT)

studyfinder@utsouthwestern.edu
All
18 Years to 64 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04990401
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Inclusion Criteria:

• Be18-64 years old;
• Able and willing to provide informed consent;
• Have moderate-to-severe depressive symptoms, with a PHQ-9 score ≥ 10;
• Insufficient moderate-to-vigorous physical activity (< 90 minutes a week);
• Demonstrated interest in increasing physical activity;
• Have a smartphone.
Exclusion Criteria:

• Have any current, past, or lifetime manic or hypomanic episode, psychosis, schizophrenia or schizophreniform disorder;
• Be currently experiencing active suicidal ideation (i.e. with suicidal thoughts, plan, and intent) or at a high risk for suicide during the course of the study, as designated by the PI;
• Have a medical condition that prohibits physical activity; be medically prohibited to exercise by primary care physician (PCP), OB-GYN (obstetrician-gynecologist) or study MD.
• Be in current, active psychotherapy
Behavioral: Behavioral Activation Teletherapy
Depression, Depressive Disorder, Depressive Episode, Depressive Symptoms
Therapy, Teletherapy, Physical Activity, Exercise
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Observational Study of Conjunctivitis in the Setting of DUPIXENT® Treatment for Atopic Dermatitis

Call 214-648-5005
studyfinder@utsouthwestern.edu
Jeremy Bartley
163697
All
18 Years to 65 Years old
This study is NOT accepting healthy volunteers
NCT04287608
STU-2020-0603
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Key
Inclusion Criteria:

• Treatment with DUPIXENT® for AD (per the current US Prescribing Information) should be ongoing, and have been initiated at least 8 weeks prior to study enrollment. NOTE: A single missed dose in the 8 weeks prior to enrollment is allowed.
• Patients with protocol-specified conjunctivitis events must present with active bilateral conjunctivitis (with or without cornea or eyelid involvement) diagnosed by the ophthalmologist (investigator) which meets all of the following criteria:
• Developed (or significantly worsened) while receiving treatment with DUPIXENT® for AD
• Is clinically significant (eg, moderate-to-severe, extensive, persistent, etc) as determined by the investigator
• There is a suspected causal relationship between DUPIXENT® and conjunctivitis because:
• Conjunctivitis is a new-onset condition or an unusual worsening of a preexisting condition (eg, significantly more severe, more extensive, or more protracted than ever before) AND
• No alternative explanation is more plausible, in the opinion of the investigator
• Reference patients must have AD treated with current ongoing treatment with DUPIXENT® for equal or longer duration as compared to group 1, with no clinical signs of ocular inflammation noted during the entire DUPIXENT® treatment Key
Exclusion Criteria:

• Any known medical, social, or personal limitations that are likely to restrict the patient's ability to undergo study visits and complete study procedures (as assessed by the investigator), including hypersensitivity or other contraindications to the anesthetic eye drops used during the ophthalmological examination. NOTE: Other protocol defined inclusion/exclusion criteria apply.
Drug: dupilumab
Conjunctivitis, Atopic Dermatitis
UT Southwestern
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A Study to Compare T-Guard vs Ruxolitinib for Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) (BMT CTN 2002) (2002)

studyfinder@utsouthwestern.edu
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04934670
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Inclusion Criteria:
To be eligible to participate in this study, patients must meet the following: 1. Patients must be at least 18.0 years of age at the time of consent. 2. Patient has undergone first allo-HSCT from any donor source or graft source. Recipients of nonmyeloablative, reduced intensity, and myeloablative conditioning regimens are eligible. 3. Patients diagnosed with Grade III/IV SR-aGVHD after allo-HSCT. SR includes aGVHD initially treated at a lower steroid dose, but must meet one of the following criteria:
• Progressed or new organ involvement after 3 days of treatment with methylprednisolone (or equivalent) of greater than or equal to 2 mg/kg/day
• No improvement after 7 days of primary treatment with methylprednisolone (or equivalent) of greater than or equal to 2mg/kg/day
• Patients with visceral (GI and/or liver) plus skin aGVHD at methylprednisolone (or equivalent) initiation with improvement in skin GVHD without any improvement in visceral GVHD after 7 days of primary treatment with methylprednisolone (or equivalent) of greater than or equal to 2mg/kg/day
• Patients who have skin GVHD alone and develop visceral aGVHD during treatment with methylprednisolone (or equivalent) of greater than or equal to 1mg/kg/day and do not improve after 3 days of greater than or equal to 2mg/kg/day Improvement or progression in organs is determined by comparing current organ staging to staging at initiation of methylprednisolone (or equivalent) treatment. 4. Patients must have evidence of myeloid engraftment (e.g., absolute neutrophil count greater than or equal to 0.5 × 109/L for 3 consecutive days if ablative therapy was previously used). Use of growth factor supplementation is allowed. 5. Patients or an impartial witness (in case the patient is capable of providing verbal consent but not capable of signing the informed consent form (ICF)) should have given written informed consent.
Exclusion Criteria:
Patients will be excluded from study entry if they meet any of the following exclusion criteria: 1. Patients who have a creatinine greater than or equal to 2mg/dL or estimated creatinine clearance less than 40 mL/min or those requiring hemodialysis. 2. Patients who have been diagnosed with active TMA, defined as meeting all the following criteria:
• Greater than 4% schistocytes in blood (or equivalent if semiquantitative scale is used e.g., 3+ or 4+ schistocytes on peripheral blood smear)
• De novo, prolonged or progressive thrombocytopenia (platelet count less than 50 x 109/L or 50% or greater reduction from previous counts)
• Sudden and persistent increase in lactate dehydrogenase concentration greater than 2x ULN
• Decrease in hemoglobin concentration or increased transfusion requirement attributed to Coombs-negative hemolysis
• Decrease in serum haptoglobin 3. Patients who have previously received treatment with eculizumab. 4. Patients who have previously received checkpoint inhibitors (either before or after allo-HCT). 5. Patients who have been diagnosed with overlap syndrome, that is, with any concurrent features of cGVHD. 6. Patients requiring mechanical ventilation or vasopressor support. 7. Patients who have received any systemic treatment, besides steroids, as upfront treatment of aGVHD or as treatment for SR-aGVHD. Reinstitution of previously used GVHD prophylaxis agents (e.g., tacrolimus, cyclosporin, MTX, MMF) or substitutes in cases with previously documented intolerance will be permitted. Previous treatment with a JAK inhibitor as part of GVHD prophylaxis or treatment is not allowed. 8. Patients who have severe hypoalbuminemia, with an albumin of less than or equal to 1 g/dl. 9. Patients who have a creatine kinase (CK) level of greater than 5 times the upper limit of normal. 10. Patients with uncontrolled infections. Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. Progression of infection is defined as:
• hemodynamic instability attributable to sepsis OR
• new symptoms attributable to infection OR
• worsening physical signs attributable to infection OR
• worsening radiographic findings attributable to infection Patients with radiographic findings attributable to infection within 4 weeks prior to enrollment must have a repeat radiographic exam within one week of enrollment that documents absence of worsening. 11. Patients with evidence of relapsed, progressing, or persistent malignancy, or who have been treated for relapse after transplant, or who may require rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse. 12. Patients with evidence of minimal residual disease requiring withdrawal of systemic immune suppression. 13. Patients with unresolved serious toxicity or complications (other than aGVHD) due to previous transplant. 14. History of sinusoidal obstruction syndrome (SOS)/veno-occlusive disease (VOD). 15. Patients with known hypersensitivity to any of the components murine mAb or Recombinant Ricin Toxin A-chain (RTA). 16. Patients who have had treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) prior to enrollment. An investigational agent is defined as medications without any known FDA or EMA approved indications. 17. Patients who have received more than one allo-HSCT. 18. Patients with known human immunodeficiency virus infection. 19. Patients who have a BMI greater than or equal to 35 kg/m2. 20. Patients who are taking sirolimus must discontinue prior to starting study treatment. The sirolimus blood level must be less than 2 ng/mL prior to starting study treatment. 21. Female patients who are pregnant, breast feeding, or, if sexually active and of childbearing potential, unwilling to use effective birth control from start of treatment until 30 days after the last study treatment. 22. Male patients who are, if sexually active and with a female partner of childbearing potential, unwilling to use effective birth control from start of treatment until 65 days after the last study treatment. 23. Patients with any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the patient; or interfere with interpretation of study data. 24. Patients whose decision to participate might be unduly influenced by perceived expectation of gain or harm by participation, such as patients in detention due to official or legal order.
Drug: T-Guard, Drug: Ruxolitinib
Steroid-Refractory Acute Graft Versus Host Disease
T-Guard, Ruxolitinib, Steroid-Refractory, GVHD, Acute GVHD, aGVHD, Grade III, Grade IV, Complete Response (CR), Transplant, Hematopoietic Stem Cell Transplant (HSCT)
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SY-1425 Plus Azacitidine in Participants With Newly Diagnosed RARA-positive Higher-Risk Myelodysplastic Syndrome

studyfinder@utsouthwestern.edu
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04797780
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Key
Inclusion Criteria:
1. Participants must be at least 18 years old at the time of signing of an informed consent. 2. Participants must be RARA-positive based on the investigational assay. 3. Participants must be newly diagnosed with HR-MDS as follows: Diagnosis of MDS according to the World Health Organization (WHO) classification (Arber 2016) and classified by the Revised International Prognostic Scoring System (IPSS R) risk category as very high, high, or intermediate risk. 4. Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2. Key
Exclusion Criteria:
1. Participants are suitable for and agree to undergo allogeneic HSCT at the time of Screening. 2. Participants who received prior treatment for MDS with any hypomethylating agent, chemotherapy or allogeneic HSCT.
Drug: SY-1425 + Azacitidine, Drug: SY-1425 Matched Placebo + Azacitidine
Myelodysplastic Syndromes
Higher-Risk, Retinoic Acid Receptor Alpha (RARA) positive, Newly Diagnosed, Myelodysplastic Syndromes
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Tractography Guided Subcallosal Cingulate Deep Brain Stimulation for Treatment Resistant Depression

studyfinder@utsouthwestern.edu
All
21 Years to 70 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03952962
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Inclusion Criteria:

• Men and women (non-pregnant) between ages 21 and 70;
• DSM-5 diagnosis a current major depressive episode (MDE) for 10 years of less, recurrent or single episode with first episode after adulthood and did not start during childhood or adolescence, secondary to nonpsychotic unipolar major depressive disorder;
• Current index MDE ≥24 months duration and/or recurrent illness with at least a total of 2 lifetime episodes (including current episode >12 months);
• Treatment resistance (defined by criteria on the Antidepressant Treatment History Form (ATHF)28): Failure to respond to a minimum of four adequate depression treatments from different categories;
• Symptom severity for Screening: Hamilton Depression Rating Scale-17 item (HDRS17) ≥20;
• Symptom severity for Outcome: Montgomery Asberg Rating Scale (MADRS) ≥27 to be met at assessment one week pre-op;
• Normal brain MRI within 3 months of surgery;
• Antidepressant medication regimen has been held stable for ≥ 30 days prior to the study screening MADRS;
• Remain on stable antidepressant medication throughout the study, unless there are safety concerns;
• Montreal Cognitive Assessment (MoCA) >25;
• Able and willing to give informed consent and agree to attend regular clinic visits for at least 12 months.
Exclusion Criteria:

• DSM-5 Axis I Disorders: any lifetime history of psychotic disorder or bipolar disorder;
• Alcohol or substance use disorder within 6 months, excluding nicotine;
• History of childhood abuse (physical or sexual) 18
• Personality disorders;
• Seeking disability during the trial;
• Current substantial suicidal risk as defined by a plan or clear immediate intent for self-harm, or made any suicide attempt within the last year; (MADRS ≥ 5 including the day of surgery);
• No stable work history;
• Neurological/Medical condition that makes the patient, in the opinion of the surgeon, a poor candidate; 1. Pregnant or has plans to become pregnant in the next 36 months; 2. Unable/unable to practice birth control through the period of randomization and withdrawal of therapy;
• Subjects who have a history of a seizure disorder;
• Subjects who will be exposed to diathermy;
• Subjects who have any medical contraindications to undergoing DBS surgery (e.g. infection, coagulopathy, or significant cardiac or other medical risk factors for surgery);
• Subjects with another implanted device such as a cardiac pacemaker, defibrillator or neurostimulator;
• Subjects who have a history of hemorrhagic stroke;
• Subjects who are unable to undergo MRI;
• Subjects who are at increased risk of hemorrhage due to underlying medical conditions or medication.
Device: Abbott Laboratories Infinity™ implantable deep brain stimulation system
Treatment Resistant Depression, Undergoing Deep Brain Stimulation (DBS) Surgery
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VItamin C in Thermal injuRY: The VICToRY Pilot Trial (VICToRY)

studyfinder@utsouthwestern.edu
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04138394
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Inclusion Criteria:

• 18 years of age or older
• Deep 2nd and/or 3rd degree burns requiring skin grafting
• Minimum burn size of =>25% Total Body Surface Area (TBSA)
Exclusion Criteria:

• >24 hours from admission to ICU or burn unit to assessment.
• Patients admitted to burn unit >24 from injury or accident.
• Patients who are moribund (not expected to survive the next 72 hours).
• Pregnancy (pregnancy will be ruled out as part of standard of care) or lactating.
• Enrollment in another industry sponsored ICU intervention study (co-enrollment in the RE-ENERGIZE trial is allowed).
• Receiving high-dose IV vitamin C already (enteral or oral vitamin C is allowed).
• Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
• Recent history of kidney stones (within the last year).
Drug: Ascorbic Acid, Drug: placebo
Shock, Thermal Burn
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Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin

Richard B Dewey, Jr., MD richard.dewey@utsouthwestern.edu
All
Not specified
This study is NOT accepting healthy volunteers
NCT05103202
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Inclusion Criteria Aim 1: 1. Patient provides responses to an internet based survey which includes consent to participate 2. Patient has been diagnosed with one or more of the conditions for which a HRQoL scale exists and will be employed in this study 3. Patient has received at least 2 prior injections with botulinum toxin for that condition by one of the study investigators 4. Both of the two most recent intervals between injections are either a) 10-weeks or less or b) 12-weeks or more Aim 2: 1. Patient provides responses to an internet based survey which includes consent to participate 2. Patient has been diagnosed with one or more of the conditions for which a HRQoL scale exists and will be employed in this study 3. Patient has received at least 2 prior injections with botulinum toxin for that condition by one of the study investigators 4. Both of the two most recent intervals between injections are either a) 10-weeks or less or b) 12-weeks or more 5. If receiving injections at 12-weeks or more, notes must have previously indicated that patient needs an injection interval of 10-weeks or less 6. If receiving injections at 12-weeks or more, the reason must be that the insurance carrier covering that patient's medical costs refused to allow a 10-week or less injection frequency
Exclusion Criteria:
For both Aims 1 and 2: 1. Patient is unwilling to consent to study procedures (refuses to fill out surveys) 2. Patient has variable injection frequencies such that the two most recent injections do not both meet criteria of being 10-weeks or less in frequency or 12-weeks or more in frequency 3. Patient has a diagnosis of and is being treated for a condition for which a HRQoL scale does not exist 4. Patient has insufficient chart documentation to characterize demographics, diagnosis, toxin selected, dose used, and injection frequency employed
Cervical Dystonia, Blepharospasm, Limb Dystonia, Hemifacial Spasm, Spasticity, Muscle, Fragments of Torsion Dystonia
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NARCOMS Registry: A Multiple Sclerosis Registry (NARCOMS)

studyfinder@utsouthwestern.edu
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT01018537
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Inclusion Criteria:

• Any individual who has been diagnosed with multiple sclerosis or clinically isolated syndrome
• Must be at least 18 years of age
Exclusion Criteria:

• None
Multiple Sclerosis
Multiple Sclerosis, NARCOMS, Global Patient Registry
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Bacteriophage Therapy in Patients With Urinary Tract Infections

studyfinder@utsouthwestern.edu
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04287478
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General
Inclusion Criteria:

• Males or females ≥18 years of age.
• Female patients of childbearing potential.
• Male patients must agree not to donate sperm up for one month.
• English-speaking. General
Exclusion Criteria:

• Stage 4 or greater chronic kidney disease (CKD).
• Abnormal liver function tests >3×upper limit of normal (ULN).
• Other conditions which could confound study results.
• Body mass index of > 40 or weight less than 50 kg.
• Known allergy to phage products.
• Pregnant and/or breastfeeding.
• Immunocompromised.
• Need for antiviral medication.
• History of severe autonomic dysreflexia.
Biological: Bacteriophage Therapy
Urinary Tract Infection Bacterial
Antimicrobial Resistance, Bacteriophage, Urinary Tract Infections, Phage
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A Study of the Efficacy and Safety of MK-5475 in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007)

studyfinder@utsouthwestern.edu
All
18 Years to 75 Years old
Phase 2/Phase 3
This study is NOT accepting healthy volunteers
NCT04732221
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Inclusion Criteria:

• Pulmonary arterial hypertension (PAH) in one of the following groups:
• Idiopathic PAH
• Heritable PAH
• Drug and toxin-induced PAH
• PAH associated with connective tissue disease, HIV infection, or congenital heart disease.
• Diagnosis of PAH documented by right heart catheterization (RHC).
• Eligibility RHC meeting all of the following criteria:
• Mean pulmonary artery pressure (mPAP) ≥25 mmHg
• Pulmonary vascular resistance (PVR) of ≥3 Wood units
• Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤15 mmHg.
• World Health Organization functional class (WHO-FC) symptoms between Class II and IV.
• Two 6-Minute walk distance (6MWD) measurements between 150 and 450 meters, one at screening and one at randomization.
• Stable concomitant background PAH-specific therapy.
• Body Mass Index (BMI) between 18.5 kg/m² and 40 kg/m² .
• Agree to be abstinent from heterosexual intercourse or use contraception during the intervention period and for at least 14 days after the last dose of study intervention.
• Female participants may not be pregnant or breastfeeding.
Exclusion Criteria:

• Group 2 to 5 pulmonary hypertension.
• PAH in one of the following groups:
• Long term responders to calcium channel blockers
• Overt features of venous/capillary involvement
• Evidence of more-than-mild obstructive lung disease.
• Evidence of more-than-mild parenchymal lung disease.
• Evidence of untreated obstructive sleep apnea (OSA).
• Evidence or history of left heart disease, including any of the following:
• Left ventricular ejection fraction (LVEF) ≤45%
• Moderate or severe left-sided valvular disease (aortic or mitral valve stenosis or regurgitation)
• Significant left ventricular diastolic dysfunction on echocardiographic evaluation
• Presence of 3 or more of the following risk factors for heart failure with preserved ejection fraction: BMI>30 kg/m², essential systemic hypertension, diabetes mellitus of any type, or coronary artery disease.
• Oxygen saturation measured by pulse oximetry (SpO₂) <90%, despite supplemental oxygen therapy.
• Chronic renal insufficiency (eGFR <30 mL/min)
• Chronic liver disease (i.e., Child-Pugh B or C), portal hypertension, cirrhosis, or significant hepatic laboratory abnormalities.
• Current smoker or currently uses electronic cigarettes (vapes).
• History of cancer, except: nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies which have been successfully treated, with appropriate follow up, and unlikely to recur for the duration of the study.
Drug: MK-5475, Drug: Placebo to MK-5475
Pulmonary Arterial Hypertension, Hypertension, Pulmonary
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Assessment Skin Quality and Efficacy of Dermal Line After Four Bipolar Radiofrequency Microneedling Treatments

Call 214-648-5005
studyfinder@utsouthwestern.edu
Jeffrey Kenkel
18673
All
21 Years to 70 Years old
N/A
This study is also accepting healthy volunteers
NCT05085730
STU-2021-0916
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Inclusion Criteria:
1. Healthy male and female adults between ages 21-70 years of age. 2. Presence of facial dermal lines and skin changes of the lower face associated with age or environmental exposure. 3. Confirmed BMI ≤ 35. 4. Subjects who can read, understand, and sign the Informed Consent Form. 5. Subjects willing and able to comply with all study requirements. 6. Fitzpatrick skin type I-VI. 7. Minimum of 1 on the Lemperle Wrinkle Assessment Scale, Allergan Fine Line Scale and Allergan Skin Roughness Scale 8. Subject is willing not to undergo any type of aesthetic procedure that could confound the study device treatment effects until he/she completes the study.
Exclusion Criteria:
1. Active localized or systemic infections, that may alter wound healing. 2. Immunocompromised subjects. 3. Subjects with coagulation disorder. 4. History of skin photosensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs). 5. Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study). 6. 5 on the Lemperle Wrinkle Assessment Scale or 4 on the Allergan Fine Line Scale and/or Allergan Skin Roughness Scales 7. Scarring in areas to be treated. 8. Tattoos in the treatment areas to be treated. 9. Significant open facial wounds or lesions. 10. Severe or cystic acne in treatment areas. 11. Current active smoker. 12. Use of Accutane (Isotretinoin) within the past 6 months. 13. Use of topical retinoids within 48 hours. 14. Use of prescription anticoagulants. 15. Pacemaker or internal defibrillator. 16. History of skin disorders resulting in abnormal wound healing (i.e. keloids, extreme dry and fragile skin). 17. Subjects on current oral corticosteroid therapy or within the past 6 months 18. Metal implants in the treatment area. 19. In the opinion of the investigator, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits. 20. Subjects with a history of radiation therapy to the treatment area. 21. Subject has a history of allergy to lidocaine or ester-based local anesthetics. 22. Subjects with significant cardiac history or rhythm disturbance who may be unable to tolerate lidocaine with epinephrine. 23. Subjects with any skin pathology or condition in the treatment area that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments (e.g. psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, hyper or hypo-skin pigmentation conditions such as post inflammatory hyperpigmentation). 24. Subjects who are unwilling to shave excessive hair in the treatment area that might influence or impair evaluation in the opinion of the Investigator. 25. Subjects have undergone skin resurfacing or tightening treatments in the treatment area over the past year. 26. Subjects have undergone dermatological treatments such as fillers and neurotoxins for the past 6 months in the treatment area. 27. Subjects have undergone laser and light treatments in the treatment area over the past 3 months. 28. Subjects have undergone superficial peel or microdermabrasion within 4 weeks.
Device: InMode Morpheus8 System
Aging
skin aging, bipolar radiofrequency, microneedling, dermal lines
UT Southwestern
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ERAS® Guidelines Validation of CRS With or Without HIPEC

studyfinder@utsouthwestern.edu
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT05185791
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Inclusion Criteria:

• Adults female and male patients (> 18 year-old)
• Peritoneal cancer from colorectal, ovarian, gastric, appendix origin and primitive peritoneal cancer (peritoneal mesothelioma)
• Multidisciplinary team meeting validation for CRS/HIPEC
• Informed and signed surgical consent
Exclusion Criteria:

• Patients without peritoneal cancer
• Patients with peritoneal cancer and extended extraperitoneal metastases contraindicating for CRS with or without HIPEC
• No informed consent signed
Other: Pre-ERAS® phase (current clinical practice), Other: Post-ERAS® implementation phase
Peritoneal Diseases
CRS, HIPEC, ERAS®, Guidelines, Peritoneal metastasis, Colorectal, Gastric, ovarian, Peritoneal mesothelioma, Pseudomyxoma peritonei
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Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery (ENCASE-II)

studyfinder@utsouthwestern.edu
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT04086550
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Inclusion Criteria:
pre-operative 1. Subjects who are able to provide written informed consent prior to participating in the clinical investigation. 2. Subjects who are ≥ 18 years old. 3. Subjects who are able to comply with the follow-up or other study requirements. 4. Subjects wo are planned for elective surgery including a trepanation to reach the subdural infratentorial space (with lower limit of incision defined as the lower edge of C2) in whom a dural incision will be closed. 5. Female subjects of child bearing potential must agree to use a form of contraception from the time of signing the informed consent form through 90 days post-surgery. intra-operative 1. Subjects with surgical wound classification Class I/Clean. 2. Subjects with minimally 5 mm of dural space surrounding dural opening.
Exclusion Criteria:
pre-operative 1. Female subjects who are pregnant or breastfeeding. 2. Subjects with an assumed impaired coagulation due to medication or otherwise. 3. Subjects suspected of an infection requiring antibiotics. 4. Subjects with any type of dural diseases in planned dural closure area. 5. Subjects requiring re-opening of planned surgical area within 90 days after surgery. 6. Subjects with a known allergy to any of the components (Lactide-Caprolactone co-polyester; Butanediol-BDI co-polyurethane; Polyethylene glycol Succinimidyl Gluterate; Disodium hydrogen phosphate or D&C Green No 6) of LIQOSEAL®. 7. Subjects who previously received a LIQOSEAL®. 8. Subjects who previously participated in this study or any investigational drug or device study within 30 days of screening. 9. Subjects with a presence of hydrocephalus. 10. Subjects with contra-indication to MRI [cardiac pacemaker or defibrillator, severe claustrophobia, injured by a metallic object that was not removed, cochlear (ear) implants, metallic implants [e.g. knee replacement]. intra-operative 1. Subjects in whom elevation of PEEP has a potential detrimental effect. 2. Subjects who will require a CSF drain, electrodes or other devices passing the dural layer or extra to intracranial bypass surgery. 3. Subjects who have primary closure of the dura mater with synthetic, nonautologous or autologous material other than galea. 4. Subjects in whom no intra-operative CSF leakage is present after primary closure of the dura mater with elevation of PEEP. 5. Subjects who after primary closure (including galea, if applicable) of the dura mater have a gap > 3 mm. 6. Subjects whom dural opening size including 5 mm margin exceeds patch size (8 x 8 cm).
Device: LIQOSEAL, Device: DuraSeal, Adherus
Cerebrospinal Fluid Leak
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RAndomized Therapy In Status Epilepticus (RAISE)

Call 214-648-5005
studyfinder@utsouthwestern.edu
Rana Said
66861
All
12 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT04391569
STU-2020-0740
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Inclusion Criteria:

• clinical and/or electrographic seizures
Exclusion Criteria:

• life expectancy of less than 24 hours
• anoxic brain injury or an uncontrolled metabolic condition as primary cause of SE
• treatment of current SE episode with IV anesthetics
Drug: Ganaxolone, Drug: Placebo
Epilepsy, Status Epilepticus, Convulsive Status EPILEPTICUS, Non-Convulsive Status Epilepticus
seizure
Children’s Health
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