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41 Study Matches

Study to Assess the Effectiveness of AboBoNT-A Injections for Adult Lower Limb Spasticity in a Real Life Cohort (AboLiSh)

The purpose of the protocol is to assess the longitudinal attainment of person-centered and function related goals of patients who receive AbobotulinumtoxinA (aboBoNT-A) injections for adult lower limb spasticity over a period of 16 months.
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studyfinder@utsouthwestern.edu
Fatma Gul
12837
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT04050527
STU-2019-1411
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Inclusion Criteria:

• Adult male and female subjects ≥18 years of age
• Primary diagnosis with unilateral adult lower limb nonprogressive spasticity.
• Subject able to take more than five steps with or without assistance.
• Decision to treat the lower limb with aboBoNT-A by the care provider made prior to, and independently from, the decision to enroll the subject in the observational study as per country label.
• Previously untreated with BoNT-A (i.e. naïve to BoNT-A), or previously treated with a BoNT-A (i.e. non-naïve to BoNT-A). For those who were previously treated with BoNTA, they should have responded to BoNT-A treatment and at least 12 weeks should have elapsed from prior injection.
• Signed informed consent prior to participation in the study.
Exclusion Criteria:

• Prior history of nonresponsiveness to BoNT-A therapy
• Previous treatment with BoNT-A of less than 12 weeks prior to enrolment in study.
• Current participation in any other clinical study or have participated within the 12 weeks prior to the Inclusion visit (Visit 1) of this study.
• Severe limitations in passive range of motion/contractures in the affected limb (MAS=4 in at least one of the joints in the lower limb).
• Limb surgery or intrathecal baclofen therapy placement for spasticity within 3 months.
• Nonambulatory subject.
• Pregnant and lactating women.
• Progressive neurological conditions or diagnosis of cerebral palsy.
Adult Lower Limb Spasticity
UT Southwestern
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Collaborative Assessment of Pediatric Transverse Myelitis: Understand, Reveal, Educate or CAPTURE Study (TMCAPTURE)

Patients and families are invited to participate in an online registry and data repository specifically for patients with transverse myelitis. Their options are to join the data repository only, or participate in a clinical sub study in conjunction with the database repository. The data generated in this study will come from surveys, interviews, review of medical records, and physical examinations. Data from this study will be utilized to guide future clinical trials for children with an acute case of Transverse Myelitis. Parents and children separately will fill out an online data base with 7 banks of surveys, each bank of survey topics have 7-10 questions. We will have both the parent and child fill out at time of symptom onset, and three time points to follow, 3, 6, and 12 months post symptom onset. A small subset of patients filling out the data registry will be able to travel to 1 of 5 treating TM centers; Children's Medical Center Dallas, Children's Hospital of Philadelphia, Hospital for Sick Children (Toronto, CA), Kennedy Krieger Institute, or Johns Hopkins University in Baltimore, MD for a physical examination highlighting recovery from Transverse Myelitis.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Benjamin Greenberg
105091
All
up to 17 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02144935
STU 012014-077
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Inclusion Criteria for the registry:
• Diagnosis of transverse myelitis (TM) or acute flaccid myelitis (AFM)
• Patient is within 6 months of symptom onset
• Ability of patent or legal guardian is able to provide informed consent
• Ability of a child 10 or older able to provide assent
• Access to the internet Exclusion Criteria for the registry:
• Inability to provide appropriate consent or assent
• Diagnosis of multiple sclerosis, neuromyelitis optica, or neuromyelitis optica spectrum disorder Inclusion Criteria for clinical sub study:
• All inclusion for the registry study
• Ability to have clinic visits 3 months ,6 months and 12 months post symptom onset Exclusion Criteria for clinical sub study:
• All exclusion criteria for the registry study
• Inability to take part in clinical assessments
Myelitis, Transverse
pediatrics
Parkland Health & Hospital System
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Clinical Evaluator Outcomes Reliability Study

This study outlines structured Clinical Evaluator (CE) testing techniques that are proposed to be implemented across all sites participating in the Cooperative International Neuromuscular Research Group (CINRG) research studies. The study will determine if the selected techniques are reliable and reproducible across the CINRG network by evaluating the reliability and reproducibility of the measures between CEs
Call 214-648-5005
studyfinder@utsouthwestern.edu
Diana Castro
102470
Male
6 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02146586
STU 082016-063
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Dystrophinopathy Participant
Inclusion Criteria:

• Site confirmed genetic diagnosis of a dystrophinopathy
• Aged 6 years and older
• Able to transfer to testing table
• Able to walk 10 meters without an assistive device Dystrophinopathy Participant
Exclusion Criteria:

• Investigator assessment of inability to comply with protocol assessments
• Participants who have attention deficient disorder or other cognitive conditions that may limit attention span to perform protocol assessments
Dystrophinopathies
Parkland Health & Hospital System
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Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears (ARC)

Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the United States and one of the fastest growing ambulatory surgery procedures. However, data on comparison of operative versus non-operative treatment is lacking and urgently needed.
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studyfinder@utsouthwestern.edu
Nitin Jain
186541
All
50 Years to 84 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03295994
STU 012018-095
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Inclusion Criteria:

• Aged =>50 years to <85 years
• Shoulder pain and/or loss of range of active motion, strength or function
• MRI-confirmed partial- or full-thickness supraspinatus and/or infraspinatus tear of 4cm or less in longitudinal dimension
• Medically fit for surgery, defined as Category I-III per American Society of Anesthesiologists (ASA) Physical Status Classification
• Ability and willingness to provide informed consent
Exclusion Criteria:

• Primary diagnosis is something other than a rotator cuff tear
• History (in last 2 years) of shoulder fracture involving the humeral head on affected side
• Previous rotator cuff surgery on affected side
• Isolated subscapularis &/or teres minor tear on affected side
• Acute rotator cuff tear caused by a severe trauma
• Shoulder used as a weight-bearing joint
• Contraindication to MRI (claustrophobia, pacemaker, pregnancy, shoulder implant, etc.)
• Glenohumeral osteoarthritis on xrays/MRI
• Grade 4 fatty infiltration of rotator cuff (any tendons)
• Candidate for shoulder arthroplasty at baseline
• Non-English speaking
Procedure: Operative, Procedure: Non-Operative
Rotator Cuff Tear
arthroscopy, physical therapy, rehabilitation, surgery, rotator cuff tear
UT Southwestern
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Nanocrystalline Gold to Treat Remyelination Failure in Chronic Optic Neuropathy In Multiple Sclerosis (VISIONARY-MS)

The objective of this trial is to assess the efficacy and safety of CNM-Au8 as a remyelinating treatment for vision-impairing MS lesions in participants who have chronic vision impairment as a result of Relapsing-Remitting Multiple Sclerosis. The primary endpoint is to assess the efficacy and safety of CNM-Au8 as a remyelinating therapy in patients with stable RMS. The secondary endpoint is Change in Functional Composite Responder Analysis Score from Baseline to Week 24.
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studyfinder@utsouthwestern.edu
Peter Sguigna
83433
All
18 Years to 55 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03536559
STU-2019-1655
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Inclusion Criteria:
1. At least 18 years of age and up to 55 years of age (inclusive) at Screening. 2. Clinical diagnosis of Relapsing Multiple Sclerosis (meeting McDonald criteria, 2010) who have had RMS no longer than 15 years from diagnosis. 3. Maximum Best Corrected High Contrast Visual Acuity (BC-HCVA) deficit on the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart of 20/200 (6/60 metric) in both eyes. a. BC-HCVA is defined as the last line on the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart that a patient is able to read three (3) or more letters correctly. 4. Best Corrected Low Contrast Letter Acuity (BC-LCLA) (by 2.5% Sloan Chart) must be 20/40 (6/12 metric) (inclusive) or worse in the affected eye and 20/32 (6/9.5 metric) or worse in the fellow eye; and the BC-LCLA must be worse than BC-HCVA for the respective value in both eyes. a. BC-LCLA is defined as the last line on the 2.5% Sloan Chart that a patient is able to read three (3) or more letters correctly. 5. Retinal Nerve Fiber Layer (RNFL) thickness ≥ 70 μm. 6. Stable disease activity based on the investigator's judgment over the previous 6 months. 7. All hematological parameters and biochemical parameters that fall outside the Within Normal Limits range must be assessed as Not Clinically Significant (NCS) and deemed stable or transient in nature. 8. Able to understand and give written informed consent.
Exclusion Criteria:
1. History of AQP4, MOG Ab(+) status, or ≥ 3 segments lesion in the spinal cord. 2. Any diagnosis other than RMS that could explain the patient's signs and symptoms. 3. An acute optic neuritis episode within the prior 6 months. 4. Clinical relapse requiring systemic steroid treatment within the prior 3 months (pre- treatment with systemic steroids during the administration of disease-modifying therapies [DMT] may be allowed after discussion with the Sponsor's Medical Monitor but must not be administered within 30 days of a planned VEP or MRI assessment). 5. Unstable treatment with a disease-modifying therapy (DMT) defined as a treatment change within prior 3-months unless due to intolerability. 6. Current treatment with immunosuppressive or immunomodulatory therapy other than those approved for the treatment of MS. 7. Any treatment with drugs known or suspected of producing retinal or optic nerve toxicity including hydroxychloroquine, chloroquine, clofazimine, vigabatrin, or ethambutol. 8. Any history of ophthalmological cause for retinal damage other than MS (e.g. cataracts, uveitis, macular degeneration, macular exudate, macular edema, glaucoma, severe astigmatism, ocular trauma, neuromyelitis optica, ischemic optic neuropathy, congenital nystagmus, retinal detachment, amblyopia, optic disk drusen). 9. Severe refractive defects: refractive errors (-6 dioptres to +6 dioptres or more in either eye, or axial eye length >26 mm), hypermetropia (> 6 dioptres; cylinder > 3 dioptres); or based on the investigators judgment any other ophthalmic diseases that would confound the study results or assessment of Visual Evoked Potential (VEPs), Best Corrected Visual Acuity (BCVA), Low Contrast Letter Acuity (LCLA), or Optical Coherence Tomography (OCT). 10. History diabetic retinopathy or a previous diagnosis of Diabetes Mellitus or history of prior impaired fasting glucose ≥126 mg/dL (or ≥ 200 mg/dL after oral glucose tolerance test). 11. History of human immunodeficiency virus (HIV), hepatitis C (HepC) virus antibody, or hepatitis B (HepB) virus antibody. 12. History of gold allergy. 13. Patients taking stimulant medications (including: amphetamine, dextroamphetamine, lisdexamfetamine, methylphenidate, or modafinil) who have not been on a stable dose greater than or equal to 30 days. Changes to dose will not be allowed during the course of the trial). 14. Patients taking clemastine fumarate, 4-aminopyridine (fampridine), or high dose Biotin (>300 mg/day). 15. Females who have a positive serum pregnancy test result at Screening or Baseline, or who are pregnant, breastfeeding, or planning to conceive during the study or within 180 days after study completion. 16. History or evidence of substance abuse or alcohol abuse within 5 years prior to Screening, including alcoholism; or severe tobacco use (>1 pack/day). 17. Clinical history of toxic neuropathy (e.g., secondary to treatment with ethambutol, isoniazid, linezolid, gentamycin, chloramphenicol, vincristine, or penicillamine). 18. Current enrollment in any other drug or device treatment study within 3 months prior to Baseline. Participation in an observational non-interventional study (i.e., no drug or device therapy) is not an exclusion criterion. 19. Inability to undergo any planned study procedures such as LCLA, VEP, MRI, or OCT; history of severe hypersensitivity to gadolinium-DTPA or reduced renal clearance (GFR must be ≥ 45 mL/min at Screening), claustrophobia; or inability to comply with study requirements based on Investigator judgment. 20. Patients with clinically significant hepatic or renal dysfunction or clinical laboratory findings that would limit the interpretability of change in liver or kidney function, or those with low platelet counts (< 150 x 10^9 per liter) or eosinophilia (absolute eosinophil count of ≥ 500 eosinophils per microliter) at Screening. 21. Based on the investigator's judgment, concurrent chronic or acute illness or unstable medical condition that may deteriorate that could confound the results of safety assessments, increase risk to the patient, or lead to difficulty complying with the protocol; including severe disc edema or hemorrhage, any clinically significant cardiac, endocrinological, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological (any progressive neurological disorder other than RRMS), dermatological, psychiatric (any untreated or unstable psychiatric disease including depression, bipolar and psychosis), renal, severe allergic or anaphylactic reactions, autoimmune, or other major confounding diseases. 22. Any history of previous malignancy, with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix, post documented full resections, with clean margins. 23. Patient is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
Drug: CNM-Au8, Drug: Placebo
Relapsing Remitting Multiple Sclerosis, Optic Neuropathy, Optic, Neuritis, With Demyelination
gold, nanocrystal, multifocal visual evoked potential, full field visual evoked potential, low contrast vision, low contrast letter acuity, remyelination, demyelination
UT Southwestern
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Prospective Clinical Assessment Study in Children With Achondroplasia (ACH)

This is a long-term, multi-center, observational study in children 2.5 to 10 years with achondroplasia (ACH). The objective is to evaluate growth, ACH-related medical complications and treatments of study participants. No study medication will be administered.
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studyfinder@utsouthwestern.edu
Garrett Gotway
12705
All
30 Months to 10 Years old
This study is NOT accepting healthy volunteers
NCT04035811
STU-2019-1762
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Inclusion Criteria:

• Signed informed consent by study participant or parent(s) or legally authorized representative (LAR) and signed informed assent by the study participant (when applicable)
• Aged 2.5 to 10 years (inclusive) at study entry
• Diagnosis of ACH
• Ambulatory and able to stand without assistance
• Study participants and parent(s) or LAR(s) are willing and able to comply with study visits and study procedures
Exclusion Criteria:

• Have hypochondroplasia or short stature condition other than ACH (e.g trisomy 21, pseudoachondroplasia, psychosocial short stature)
• In females, having had their menarche
• Height < -2 or > +2 standard deviations for age and sex based on reference tables on growth in children with ACH
• Annualized height growth velocity ≤1.5 cm/year over a period ≥6 months prior to screening
• Have a concurrent disease or condition that in the view of the Investigator and/or Sponsor, may impact growth or where the treatment is known to impact growth.
• Significant abnormality in screening laboratory results.
• Have been treated with growth hormone, insulin-like growth factor 1 (IGF 1), or anabolic steroids in the previous 6 months or long-term treatment (>3 months) at any time
• Have received a C-type natriuretic peptide (CNP) analog or treatment targeting fibroblast growth factor receptor (FGFR) inhibition at any time
• Have had regular long-term treatment (>1 month) with oral corticosteroids (low-dose ongoing inhaled steroid for asthma is acceptable)
• Have used any other investigational product or investigational medical device for the treatment of ACH or short stature
• Have had previous limb-lengthening surgery
Achondroplasia
Skeletal dysplasia, Endochondral ossification, ACH, Shortened proximal limbs, Fibroblast growth factor receptor 3, FGFR3, Endochondral bone formation, Short-limb disproportionate dwarfism, Bone disease, Dwarfism, Bone diseases, Musculoskeletal diseases, Osteochondrodysplasia, Genetic diseases, Inborn
Parkland Health & Hospital System
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Expanded Access Study Amifampridine Phosphate in Lambert-Eaton Myasthenic Syndrome (LEMS), Congenital Myasthenic Syndrome (CMS), or Downbeat Nystagmus Patients (EAP-001)

The primary objective of the study is: • To provide patients with LEMS/CMS/downbeat nystagmus access to amifampridine phosphate therapy until the product becomes commercially available. The secondary objective of the study is: • To assess the long-term safety of amifampridine phosphate in patients with LEMS/CMS/downbeat nystagmus
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studyfinder@utsouthwestern.edu
Sharon Nations
15233
All
10 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02189720
STU 032017-008
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Inclusion Criteria:

• Male or female:
• 2 years of age at 5 pediatric CMS study sites
• 10 years of age at other study sites.
• Confirmed physician diagnosis of LEMS, CMS or downbeat nystagmus.
• Completion of anti-cancer treatment at least 3 months (90 days) before treatment.
• Negative urine pregnancy test for females of childbearing potential at Screening.
• If sexually active and of childbearing potential, willing to use 2 acceptable methods of contraception from screening visit until 3 months after the last dose of investigational product. No adequate clinical data on exposed pregnancies are available for amifampridine. No nonclinical safety data are available regarding the effects of amifampridine on reproductive function. Amifampridine phosphate should not be used during pregnancy. It is unknown whether amifampridine is excreted in human breast milk. The excretion of amifampridine in milk has not been studied in animals. Amifampridine phosphate should not be used during breastfeeding.
• Any subject currently participating in studies LMS-002, LMS-002EXT, or CMS 001 is immediately eligible for enrollment into study EAP-001, as long as inclusion/exclusion criteria are still met.
• Willing and able to provide written informed consent after the nature of the study has been explained and before the start of any research-related procedures.
Exclusion Criteria:

• History of epilepsy.
• CMS subtypes including slow-channel syndrome, LRP4 deficiency, and acetylcholinesterase deficiency.
• Known active brain metastasis. Patients with treated brain metastasis (radiotherapy and/or surgery) who have completed treatment for their brain metastasis >90 days before Screening, are neurologically stable (neurological symptoms grade <1), are on a stable dose of corticosteroids and have no evidence of new disease on magnetic resonance imaging (MRI) are eligible, provided they meet the other inclusion/exclusion criteria.
• Current use of dalfampridine (Ampyra®; 4-aminopyridine), and any form of 3,4 DAP other than the investigational product provided, such as amifampridine base and does not agree to discontinue use for the duration of the study.
• Use of guanidine hydrochloride within 7 days of starting amifampridine phosphate treatment.
• History of drug allergy to any pyridine-containing substances or any amifampridine phosphate excipients (i.e. microcrystalline cellulose, colloidal silicon dioxide or calcium stearate).
• Use of any other investigational product (other than 3,4 DAP or amifampridine phosphate) or investigational medical device within 30 days before starting treatment or requirement for any investigational agent before completion of all scheduled study assessments.
• An electrocardiogram (ECG) within 6 months before starting treatment that shows clinically significant abnormality(ies), in the opinion of the patient's personal physician.
• History of additional risk factors for torsade de pointes (e.g. history of surviving a near drowning due to loss of consciousness, family history of congenital QT syndrome, long QT syndrome, family history of unexplained early sudden death, or heart failure).
• Breastfeeding or pregnant or planning to become pregnant (self or partner). Male patients with breastfeeding partners are not excluded from the study.
• History of severe renal impairment or evidence of severe renal impairment at time of Screening on laboratory tests, specifically a creatinine clearance <30 mL/min (within 30 days) as calculated using the Cockcroft Gault formula.
• History at time of Screening of laboratory tests (within 30 days) indicating hepatic impairment: o In patients without liver metastases from cancer, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or total bilirubin >1.5 × upper limit of normal (ULN).
• Any condition that, in the view of the Principal Investigator, places the patient at high risk of poor treatment compliance or of not completing the study.
Drug: Amifampridine Phosphate
Lambert-Eaton Myasthenic Syndrome, Congenital Myasthenic Syndrome, Downbeat Nystagmus
Amifampridine Phosphate, Amifampridine, 3,4-Diaminopyridine Phosphate, 3,4-Diaminopyridine, 3,4-DAP, LEMS, CMS, Lambert-Eaton Myasthenic Syndrome, Congenital Myasthenic Syndrome, Neuromuscular disorders, Neuromuscular, eye movement, electromyography, EMG, Expanded Access, Firdapse®, Downbeat Nystagmus
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Arimoclomol in Amyotropic Lateral Sclerosis

A multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of arimoclomol in amyotropic lateral sclerosis (ALS)
Call 214-648-5005
studyfinder@utsouthwestern.edu
Sharon Nations
15233
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03491462
STU-2018-0264
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Inclusion Criteria:

• Subject meets revised El Escorial criteria for clinically possible, clinically probable / Clinically probable ALS laboratory-supported or clinically definite ALS, or familial ALS
• 18 months or less since first appearance of weakness (e.g. limb weakness, dysarthria, dysphagia, shortness of breath).
• ALSFRS-R equal to or above 35 and erect (seated) SVC% predicted equal to or above 70% at screening
Exclusion Criteria:

• Tracheostomy or use of non-invasive ventilation for more than 2 hours during waking hours at the time of screening or baseline
• pregnant or breast-feeding
• current or anticipated use of diaphragmatic pacing
• Any other relevant medically significant condition which could present risk to the subject or interfere with the assessment of safety or has an increased risk of causing death during the trial
Drug: Arimoclomol, Drug: Placebo oral capsule
Amyotrophic Lateral Sclerosis
arimoclomol, ALS
UT Southwestern
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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.
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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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7 Tesla MRI Study in Patients With Statin Related Muscle Complaints

Roughly 5-10% of statin-treated patients report muscle pain, aches, weakness, cramps, stiffness, or "heaviness" - typically occurring symmetrically in the legs. For healthcare providers, the major diagnostic challenge is to unambiguously link these symptoms to statin use, especially since some patients can have normal serum creatine kinase (CK) levels despite demonstrable weakness and muscle biopsy proven statin-induced myopathy . No well accepted, standardized, or Food and Drug Administration (FDA)-endorsed diagnostic method exists for statin-induced muscle injury. This lack of an objective diagnostic methodology blocks vertical advancement of the field. The successful completion of this project will develop in vivo techniques that will provide insight into how statins affect muscle metabolism and help establish a methodology to objectively diagnose muscle injury due to statins. The development of an MRS technique will allow for in-vivo analyses and the data accumulated here will serve as preliminary data for futher extramural funding of studies with much larger sample sizes. Ultimately, this focus of research will lead to improved diagnosis and treatment of patients with statin-related muscle complaints, which is central to obtaining the cardiovascular risk reduction from lipid-lowering drugs.
Call 214-648-5005
studyfinder@utsouthwestern.edu
Zahid Ahmad
69829
All
18 Years to 80 Years old
This study is also accepting healthy volunteers
NCT04575090
STU 012016-017
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Inclusion Criteria:
Adults age >18 yrs or <80 yrs Patients reporting complaints of statin-associated muscle symptoms, aches, weakness, cramps, or stiffness of legs.
Exclusion Criteria:
Patients who drink large quantities of grapefruit juice (>1 quart daily)
Muscle Weakness, Muscle Cramp, Statin-related Muscle Pain, Muscle Aches, Muscle Stiffness
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Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)

Shoulder pain accounts for 16% of all musculoskeletal complaints in the healthy adult population. Subacromial impingement syndrome (SIS) is the most common cause of shoulder pain. Many patients with chronic pain from subacromial impingement syndrome (SIS) will fail treatment efforts and have longstanding pain. This project will evaluate the efficacy of a novel approach to treatment, percutaneous peripheral nerve stimulation, for participants with chronic shoulder pain due to subacromial impingement syndrome (SIS).
Call 214-648-5005
studyfinder@utsouthwestern.edu
Nitin Jain
186541
All
21 Years to 100 Years old
N/A
This study is also accepting healthy volunteers
NCT03752619
STU-2020-0352
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Inclusion Criteria:
1. Shoulder pain of >3 months 2. Age>=21 3. Worst pain in the last week>=4 (0-10 scale) 4. Ability to check skin and perform dressing changes, independently or with assistance 5. Stable dose of pain medication (Not taking more than than 1 opioid or 1 non-opioid analgesic)
Exclusion Criteria:
1. Current shoulder joint or overlying skin infection, or current bacterial infection requiring antibiotics 2. Other chronic pain syndrome (Pain in another area of the body 15 or more days in the last 30 (more than half of the time) or taking daily analgesics for another pain syndrome) 3. Prior shoulder surgery to ipsilateral shoulder joint (glenohumeral, rotator cuff, acromioclavicular (AC) Joint, etc.) 4. Corticosteroid injection in the ipsilateral shoulder or any other pain relieving treatment in last 12 weeks 5. Uncontrolled bleeding disorder 6. Medical instability based on physician opinion after review of medical information 7. Pregnancy 8. Neurological condition affecting ipsilateral upper limb (such as central neurologic injury/illness, radiculopathy, diabetic amyotrophy, Complex Regional Pain Syndrome, etc.) 9. Current Worker's compensation claim for the ipsilateral shoulder 10. Shoulder instability, severe glenohumeral osteoarthritis(OA) based on patient symptoms and physical examination 11. Ipsilateral shoulder injury due to severe trauma (Fall from greater than standing height; Motor vehicle crashes; Struck by vehicle or other fast-moving projectile (e.g., bullet, baseball, etc.); Assault (i.e., injuries intentionally inflicted by another person)) 12. Current osseus fracture in ipsilateral arm 13. Ipsilateral upper limb amputation other than a single digit (digits 2-5, partial or full) 14. Surgical indication for shoulder treatment based on physician opinion 15. Compromised immune system (immunodeficiency or immunosuppression) 16. Current use of a Deep Brain Stimulation (DBS) system, implanted active cardiac implant (e.g. pacemaker or defibrillator), any other implantable neuro-stimulator whose stimulus current pathway may overlap with that of the SPRINT System 17. Patients who have a tape or adhesive allergy 18. Contraindication to Magnetic resonance imaging (metal in body, claustrophobia, body habitus, etc)
•exclude from Magnetic resonance imaging (MRI) only
Device: Contracting Producing Peripheral Nerve Stimulation, Device: Non Contracting Producing Peripheral Nerve Stimulation, Other: Physical Therapy
Shoulder Pain, Shoulder Impingement Syndrome, Shoulder Tendinitis, Shoulder Bursitis, Pain, Shoulder
peripheral nerve stimulation, Sprint, stimulation
UT Southwestern
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