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602 Study Matches

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A Phase 2 Study to Assess the Safety, Tolerability, Exploratory Efficacy, and Pharmacokinetics of Orally Administered JBPOS0101 for Refractory Infantile Spasms Patients

A Study of Orally Administered JBPOS0101 in Refractory Infantile Spasms Patients

Katherine Nickels
All
6 months to 36 months old
Phase 2
This study is NOT accepting healthy volunteers
0000-122427-P01-RST
19-007102
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Inclusion Criteria:

  • Male or female between 6 months through 36 months of age at the time of informed consent as clinical diagnosis of IS, confirmed by video-electroencephalogram (EEG) analysis, and hypsarrhythmia on EEG at screening according to the Burden of Amplitudes and Epileptiform Discharges (BASED) scale score.
  • As assessed by the investigator has no or partial response to at least 2 out of the 3 therapies of adrenocorticotrophic hormone (ACTH), vigabatrin, and glucocorticoids (i.e. prednisolone), or has no or partial response to at least 1 out of the 3 therapies of ACTH, vigabatrin, and glucocorticoids and is contraindicated to and/or refused by the patient’s legal representative(s) for treatment with one or both other 2 therapies.
  • Patient has general good health (defined as the absence of any clinically relevant abnormalities as determined by the investigator) based on physical and neurological examinations, medical history, normal renal function and electrocardiogram (ECG), and clinical laboratory values completed during the Screening Period visit (Visit 1).


Exclusion Criteria:

 

  • Patient considered by the investigator, for any reason (including, but not limited to, the risks described as precautions and warnings in the current version of the investigator’s brochure for investigational product) to be an unsuitable candidate to receive the investigational product.
  • Patient has known or suspected allergy to the investigational product or apple juice.
  • Patient has clinically significant renal impairment, defined as creatinine > mg/dL or blood urea nitrogen > 2 × upper limit of normal (ULN); clinically significant liver dysfunction, defined as total bilirubin ≥ 2 × ULN, or aspartate aminotransferase or alanine aminotransferase ≥ 3 × ULN; has clinically significant abnormal laboratory values; the investigator may deem the patient eligible if he/she judges the laboratory values to be not clinically significant.
  • Patient has an ongoing or known history of human immunodeficiency virus infection, or chronic hepatitis B or C.
  • Patient has a clinically significant abnormality on ECG that, in the opinion of the investigator, increases the safety risks of participating in the study.
  • Patient has a neurodegenerative disorder as the underlying cause of IS.
  • Patient has a known history of aspiration pneumonia within the past year.
  • Patient has previously participated in another clinical study of the investigational product or received any investigational drug or device or investigational therapy within 30 days of study entry.
  • Patient has received therapy with felbamate, cannabinoids, ketogenic diet or vagus nerve stimulation within 14 days of screening.
  • Patient has received therapy with a medication known to be a CYP3A4 substrate and whose PK has been shown to be impacted in the presence of a CYP3A4 inhibitor within 14 days impacted in the presence of a CYP3A4 inhibitor within 14 days of screening.
  • Patient has not remained at stables doses of all drugs used for treating epileptic seizures for at least 14 days prior to screening (except for rescue medications used for acute treatment of breakthrough seizures which are not known to be CYP3A4 substrates and whose PK has not been shown to be impacted in the presence of a CYP3A4 inhibitorist of CYP3A4 substrates]).
  • Patient has a lethal or potentially lethal condition other than infantile spasms, with a significant risk of death before 18 months of age such as non-ketotic hyperglycinemia.
  • Patient has an underlying metabolic disease associated with glucose intolerance (e.g., glucose transporter deficiencies).
  • Patient has a body weight below 5 kg.
Drug therapy, Drug
JBPOS-0101, Refractory infantile spasms, West syndrome
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Estimation of Sleep Timing and Duration Using Actigraphy in Patients with Symptoms of Autonomic Dysfunction

A Study Using A Motion Device to Estimate Sleep Timing and Duration in Patients with Autonomic Dysfunction

Robin Lloyd
All
12 years to 18 years old
This study is NOT accepting healthy volunteers
0000-122436-H01-RST
19-007233
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Inclusion Criteria:

  • Adolescent patients between 12 and 18 years old, inclusive.
  • Patients being evaluated at the Pediatric Diagnostic Referral Clinic for symptoms of suspected orthostatic intolerance (OI), postural orthostatic tachycardia syndrome (POTS), or autonomic dysfunction or already carry diagnosis of OI, POTS, or autonomic dysfunction. Identified with pre-appointment triaging to have any of the following symptoms: dizziness, lightheadedness, fainting, heart racing, shortness of breath, vision changes, fatigue, exercise intolerance, and chest pain when standing.


Exclusion Criteria:

  • Age not within 12-18 years old.
  • Lack of assent from child to participate/wear actigraph.
Dysautonomia, Orthostatic intolerance, POTS
Disorder of autonomic nervous system, Postural orthostatic tachycardia syndrome
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Mayo Clinic Diet Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes: A Randomized Clinical Trial (PHENO-Diet Trial)

A Study to Evaluate Individualized Lifestyle Intervention for Obesity Management Based on Obesity Phenotypes

Andres Acosta
All
18 years to 65 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-122466-H01-RST
19-007485
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Inclusion Criteria:
 

  • Adults with obesity (BMI >30Kg/m2); these will be otherwise healthy individuals with no unstable psychiatric disease and uncontrolled life-threatening comorbidities (i.e., unstable angina).
  • Age: 18-65 years old. 
  • Gender: Men or women.


Exclusion Criteria:
 

  • Weight change greater than 3% in the previous 3 months (weight stable).
  • History of bariatric surgery including lap band and bariatric endoscopy. 
  • Significant untreated psychiatric dysfunction including binge eating disorders and bulimia.
  • Current use of anti-obesity pharmacotherapy, medications known to affect weight (e.g., corticosteroids) or GLP-1 agonist/analog for T2DM.
  • A positive score on the AUDIT-C questionnaire as judged by an investigator. 
  • Patient has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence.
Behavioral, Dietary treatment for disorder, Weight maintenance regimen, Weight monitoring, Weight reduction regimen
Obesity
Obesity
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

A Study to Evaluate the Effectiveness and Safety of Rozanolixizumab in Adult Patients with Generalized Myasthenia Gravis

Elie Naddaf
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-122467-P01-RST
19-007490
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Inclusion Criteria:
 

  • Study participant must be ≥ 18 years of age at the time of signing the informed consent.
  • Study participant has documented diagnosis of generalized myasthenia gravis (gMG) at Visit 1, based on study participant's history and supported by previous evaluations.
  • Study participant has a confirmed positive record of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) prior to Visit 1.
  • Study participant has Myasthenia Gravis Foundation of America (MGFA) Class II to IVa at Visit 1.
  • Study participant with a MG-ADL score of at least 3 (with > 3 points from non-ocular symptom) AND a QMG score of at least 11 at Visit 1 and at Baseline (Visit 2).
  • Study participant is considered for additional treatment such as IVIg or PEX by the Investigator.
  • Body weight ≥ 35kg at Visit 1.
  • A male study participant must agree to use contraception as detailed in this protocol during the Treatment Period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period.
  • Female study participants of childbearing potential must agree to use a highly effective method of birth control, during the study and for a period of at least 90 days after their final dose of study medication. According to the ICHM3 (R2), highly effective forms of birth control are methods that achieve a failure rate of less than 1% per year when used consistently and correctly.
  • A female participant is eligible to participate if she is not pregnant), not breastfeeding, and at least one of the following conditions applies:
    • Not a woman of childbearing potential (WOCBP); OR
    • A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 90 days after the last dose of study treatment. The study participant must have a negative serum pregnancy test at Visit 1, which is confirmed to be negative by urine testing prior to the first dose of study medication at Visit 2.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.


Exclusion Criteria:
 

  • Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant’s ability to participate in this study.
  • Study participant has a history of alcohol use disorder or other substance use disorder (as per Diagnostic and Statistical Manual of Mental Disorders-5) within 12 months prior to Visit 1. 3.
  • Study participant has a known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol.
  • Study participant has a known history of hyperprolinemia, since L-proline is a constituent of the rozanolixizumab formulation.
  • Study participant has a clinically relevant active infection (e.g., sepsis, pneumonia, or abscess) in the opinion of the Investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of IMP.
  • Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current/history of nontuberculous mycobacterial infection (NTMBI) will be excluded.
  • Study participant has been previously received rozanolixizumab drug product.
  • Study participant has received a live vaccination within 8 weeks prior to Visit 2; or intends to have a live vaccination during the course of the study or within 8 weeks following the final dose of IMP.
  • Study participant has been treated with prohibited immunosuppressants, biologics, and other therapies within timeframe shorter than no-treatment period.
  • Study participant has been treated with any biological agent in the past 3 months or within 5 half-lives prior to Visit 2, whichever was longer.
  • Study participant has prior treatment with rituximab in the 6 months prior to Visit 2 or study participant has prior treatment with rituximab in the 12 months prior to Visit 2 and B cells monitoring have shown they did not return to normal range.
  • Study participant had a thymectomy in the past 6 months or a thymoma at any time that required chemotherapy and/or radiotherapy prior to Visit 1. 13a.Study participant has active inflammatory bowel disease (IBD), diverticular disease, or GI ulceration or history thereof in past 6 months prior to Visit 1.
Drug, Other, Drug therapy
Myasthenia gravis
Myasthenia gravis, Nervous system, Peripheral nervous system, Rozanolixizumab
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A Multicenter Study to Evaluate Long-term Safety and Tolerability of Open Label Sacubitril/Valsartan in Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed Study CLCZ696B2319

An Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With Heart Failure (HF)

Jonathan Johnson
All
1 years to 18 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-122476-P01-RST
19-007558
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Inclusion Criteria:

  • Signed informed consent.
  • On study drug at PANORAMA-HF Part 2 EOS visit. Does not have any significant safety issue.


Exclusion Criteria:
 

  • Subject only participated in PANORAMA-HF Part 1 or was a SF in PANORAMA-HF or permanently discontinued study drug in PANORMA-HF Part 2.
  • Use of investigational drugs within 5 half-lives of enrollment or within 30 days (longer duration); with the exception of PANORAMA-HF study drug (requires ≥ 36-hour washout before baseline visit).
  • History of hypersensitivity or allergy to study treatment, its excipients or drugs of similar chemical class, ACEIs, ARBs, or NEP inhibitor and known/suspected contraindications to sacubitril/valsartan.
  • Renal vascular hypertension (including renal artery stenosis).
  • Significant renal estimated glomerular filtration rate disorder (eGFR calculated using modified Schwartz formula < 30% mean GFR for age); hepatic disorder (serum aspartate aminotransferase or alanine aminotransferase > 3 times upper limit of normal); gastrointestinal disorder or biliary disorder.
  • History of angioedema.
  • Parents or legal guardians of subject who do not give consent or allow the child to give assent, or inability of patient or parents/legal guardians to follow instructions or comply with follow-up procedures.
  • Any medical condition(s) that may put the patient at risk in the investigator's opinion or that the investigator deems unsuitable for the study.
  • Other protocol defined inclusion/exclusion criteria may apply.
Drug, Drug therapy
Congenital heart defects in children, Heart failure
AHU-377, Cardiovascular system, Chronic systolic dysfunction of left ventricle, Left heart failure, Sacubitril mixture with valsartan, Valsartan, sacubitril, sacubitril / valsartan, valsartan
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Virtual Remote Control Robotic Percutaneous Coronary Intervention: A Pilot First in Human Feasibility Study

A Study to Evaluate Virtual Remote Control Robotic Percutaneous Coronary Intervention

Mackram Eleid
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
0000-122485-H01-RST
19-007712
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Inclusion Criteria:

  • Adult patients (> 18 years old) undergoing elective planned percutaneous coronary intervention (PCI) of one coronary artery territory.
  • Target coronary lesion is suitable for robotic PCI at discretion of the primary operator.
  • Either femoral or radial approach planned for procedure.
  • Patient must be able to tolerate dual antiplatelet therapy and give written informed consent.


Exclusion Criteria:

  • Hemodynamic instability, cardiogenic shock or anticipated need for hemodynamic support device use.
  • Severely calcified coronary lesion or anticipated need for rotational atherectomy.
  • Chronic total occlusion.
  • Unrevascularized multivessel coronary artery disease.
  • Left ventricular ejection fraction < 35%.
  • Advanced renal dysfunction (defined as GFR < 30 ml/min).

 

Device, Antiplatelet agent therapy, Long term dual antiplatelet drug therapy indicated, Percutaneous coronary intervention, Robotic assisted surgery
Coronary angioplasty and stenting, Robotic surgery
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Evaluation of Bile Acid Reflux in Patients with Recurrent Barrett’s Esophagus

A Study to Evaluate Bile Acid Reflux in Patients with Recurrent Barrett’s Esophagus

Kenneth Wang
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
0000-122501-H01-RST
19-007916
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Inclusion Criteria:

  • Age 18 years or older.
  • Dysplastic BE (either low or high grade) or BE-related intramucosal EAC on initial diagnosis successfully treated with endoscopic therapy with negative surveillance endoscopy for at least one year from endoscopic therapy.
  • Dysplastic BE (either low or high grade) or BE-related intramucosal EAC on initial diagnosis successfully treated with initial endoscopic therapy with remission across two subsequent surveillance endoscopies but evidence of recurrence of intestinal metaplasia, dysplasia, or EAC by the third surveillance endoscopy.
  • Tolerance of endoscopy.
  • Ability to give informed consent.


Exclusion Criteria:

  • Age < 18 years old.
  • Pregnancy.
  • Prior gastric surgery.
  • Use of any bile acid sequestrants (cholestyramine, colestipol, and colesevelam) at the time of enrollment.
  • Evidence of biliary obstruction or cholestasis due to any reason, defined as total bilirubin above the upper limit of normal, alkaline phosphatase above the upper limit of normal, and/or clinical evidence of jaundice.
  • Active esophagitis or stricture precluding passage of endoscope and completion of endoscopic procedure.
  • Coagulopathy, defined as INR > 1.5 or platelet level 50,000 precluding completion of endoscopic procedure.

 

Barrett's esophagus, Bile reflux
Barretts esophagus with dysplasia, Digestive system, Duodenogastric reflux, Primary adenocarcinoma of lower third of esophagus due to Barrett esophagus, Therapeutic endoscopy
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Ability of Hearing Aids and Wearable Sensors to Detect Falls

A Study to Evaluate Ability of Hearing Aids and Wearable Sensors to Detect Falls

Kenton Kaufman
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122510-P01-RST
19-007965
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Inclusion Criteria:

  • No fall history in the past 6 months.
  • Independent in their daily life.


Exclusion Criteria:
 

  • Participants with chronic or current pain.
  • Particiupants using prostheses or assistive devices.
  • Participants with visual abnormality, proprioceptive loss, or peripheral neuropathy.
Vestibular disorder
Auditory/vestibular test abnormal, Does use hearing aid, Hearing aid fitting, Vestibular function test normal, Vestibular test
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A Phase 3, Open-label, Single-arm, Multi-center Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot (CAM2029) in Patients With Acromegaly

A Study to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

Irina Bancos
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-122534-P01-RST
19-008241
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Inclusion Criteria - For Roll-over Patients from Trial HS-18-633:

  • Patients who attend the Week 24 visit of the preceding trial (HS-18-633) and are willing to continue their participation in this trial.
  • Written informed consent of the patient.
  • Patients must be willing to use an acceptable method of contraception during the entire trial.

Inclusion Criteria - For New Patients:

  • Able to provide written informed consent to participate in the trial prior to any
    trial-related procedures are performed .
  • Willingness and ability to comply with the requirements of the protocol.
  • Male or female patients, ≥ 18 years at screening.
  • Diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly
    as documented by:
    • IGF-1 levels > 1 x ULN;
    • Pituitary adenoma on magnetic resonance imaging (MRI) or pathology report Computerized tomography (CT) is accepted if MRI could not be performed;
    • IGF-1 levels >1 x ULN measured at least 3 months after the surgery for patients who have undergone pituitary surgery.
  • Treatment with a stable dose of octreotide LAR (10 mg, 20 mg, 30 mg or 40 mg) or
    lanreotide ATG (60 mg, 90 mg or 120 mg) for at least 3 months as monotherapy prior to
    screening.
  • IGF-1 levels >1 x ULN and ≤ 2.0 x ULN at screening (adjusted for age and sex; mean
    value of the first measurement at screening and the second measurement at 2 weeks
    before Day 1) with or without prior pituitary radiotherapy (at least 3 years prior to
    screening), or IGF-1 levels ≤ 1 x ULN at screening (adjusted for age and sex; mean value of the first measurement at screening and the second measurement at 2 weeks before Day 1), with prior pituitary radiotherapy at least 3 years prior to screening and confirmed disease activity defined as IGF-1 levels > 1 x ULN during drug holiday 3 to 9 months prior to
    screening.
  • Patients must have adequate liver, pancreatic, renal and bone marrow functions:
    • Adequate liver function:
      • Total serum bilirubin ≤ 1.5 x ULN*;
      • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 x ULN;
      • International normalized ratio (INR) < 1.3.
    • Adequate pancreatic function:
      • Amylase and lipase ≤ 2 x ULN.
    • Adequate renal function:
      • Estimated glomerular filtration rate ≥ 60 mL/min by the Modification of Diet in Renal Disease formula.
    • Adequate bone marrow function:
      • Platelets ≥ 100 x 10^9/L;
      • Hemoglobin > 9 g/dL;
      • White blood cells > 3.0 x 10^9L.

*Patients with previous diagnose of Gilbert’s syndrome may be included if the disease is not
accompanied by other hepatobiliary disorders and if the total bilirubin is < 3 mg/dL
(< 51.3 μmol/L) and the direct bilirubin is ≤ ULN.

  • Normal ECG defined as the following as determined by the mean value of a triplicate ECG:
    • Resting heart rate 50-105 bpm;
    • QTc interval corrected by Fridericia’s formula (QTcF) <450 msec.
  • Female patients of childbearing potential must be willing to use an acceptable method of contraception during the entire trial.
  • Male patients must be willing to use condoms throughout the trial unless they have been sterilized by vasectomy (with an appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).


Exclusion Criteria:

For Roll-over Patients from Trial HS-18-633

  • Unresolved, drug-related serious adverse event (SAE) from the preceding trial (HS-18-633).
  • Patients who, based on the Investigator's judgment, have a clinically significant or unstable medical or surgical condition that may preclude safe and complete trial participation. Conditions may include cardiovascular, peripheral vascular, pulmonary, hepatic, renal, or neurological disease, as determined by physical examination, laboratory tests or ECG.
  • Pregnancy.

For New Patients

  • Have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening [whichever is longer]).
  • Currently receiving other treatments known to affect GH or IGF-1 concentration (including oral estrogens for e.g. contraception or replacement treatment in hypogonadism or during menopause).
  • Patients who usually take octreotide LAR or lanreotide ATG less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks).
  • Compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated.
  • Patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening. Patients who have undergone surgery more than 1 month from screening must have recovered from the treatment and be in good clinical condition.
  • Patients who have undergone pituitary surgery within 6 months prior to screening
  • Patients who have received prior pituitary irradiation within 3 years prior to screening
  • A history of another primary malignancy except the following:
    • Stable and well-differentiated microcarcinoma of the thyroid
    • Non-melanoma skin cancer, and carcinoma in situ of the cervix, uterus, or breast from which the patient has been disease-free for ≥3 years
    • A primary malignancy that has been completely resected and in complete remission for ≥5 years.
  • Participation in any other clinical trial to test an investigational drug or device within the last 30 days before screening
  • Patients with poorly controlled diabetes mellitus, defined as hemoglobin A1c (HbA1c) >8.0%
  • Patients with diabetes mellitus who have initiated treatment with insulin or who have changed the insulin treatment regimen within 6 weeks prior to screening
  • Hepatic/pancreatic-related exclusion criteria
    • Presence of hepatitis B surface antigen
    • Current hepatitis C virus infection
    • History of alcohol/drug misuse within the past 12 months
    • Patients with symptomatic cholelithiasis within 3 months from screening (patients with non-symptomatic cholelithiasis/sludge and patients who have undergone cholecystectomy more than 1 month from screening can be included in the trial)
  • Patients with presence of active or suspected acute or chronic uncontrolled infection or
  • immunocompromised patients, including patients with positive human
  • immunodeficiency virus (HIV) test result
  • Cardiac exclusion criteria: cardiac or cardiac repolarization abnormality, including any
  • of the following:
    • a. History of myocardial infarction, angina pectoris or coronary artery bypass graft
    • within 6 months prior to screening
    • b. Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete
    • left bundle branch block, high-grade atrioventricular (AV) block (e.g. bifascicular
    • block, Mobitz type II and third-degree AV block)
    • c. Long QT syndrome, family history of idiopathic sudden death or congenital long
    • QT syndrome, or any of the following:
    • i. Risk factors for Torsades de Pointes including uncorrected hypokalemia or
    • hypomagnesemia, history of cardiac failure or history of clinically
    • significant/symptomatic bradycardia
    • ii. Concomitant medication(s) with a “Known risk of Torsades de Pointes” that cannot be discontinued or replaced by
    • safe alternative medication/s. A wash-out of 5 half-lives or 7 days
    • (whichever is longer) from previous treatment with drugs with a known
    • risk of Torsades de Pointes is required prior to the first dose of CAM2029
    • iii. Inability to determine the QTcF interval
  • Uncontrolled hypertension defined by a systolic blood pressure >160 mmHg and/or
  • diastolic blood pressure >100 mmHg. The patient needs to be on a stable dose of
  • antihypertensive medication for at least 4 weeks before screening
  • Untreated or uncontrolled hypothyroidism, hypoadrenalism or diabetes insipidus.
  • Patients must be adequately treated with stable doses of replacement therapy for a
  • minimum of 3 months prior to screening
  • Any other current or prior medical condition that may interfere with the conduct of the
  • trial or the evaluation of its results in the opinion of the Investigator or the Sponsor’s
  • Medical Monitor
  • Pregnant, lactating or planning to be pregnant during the trial
  • Clinically significant laboratory abnormalities, which in the opinion of the Investigator
  • may prevent the patients from safely participating in the trial
  • Any known allergy, hypersensitivity or intolerance to octreotide or any related drug, or
  • history of any drug hypersensitivity or intolerance which in the opinion of the
  • Investigator, would compromise the safety of the patient or the trial
  • Any other contraindicated serious medical condition, which in the opinion of the
  • Investigator may prevent the patients from safely participating in the trial.
  • Unwilling or unable to comply with the requirements of the protocol or in a situation or  condition that, in the opinion of the Investigator, may interfere with participation in the trial.
  • On the staff, affiliated with, or a family member of the personnel directly involved with this trial.
Drug, Drug therapy, Medication administration: subcutaneous
Acromegaly
Acromegaly, Endocrine system, Lanreotide, Octreotide, lanreotide, octreotide
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Non-invasive Near-infrared Spectroscopy (NIRS) versus Invasive Licox Intracranial Pressure Monitoring in Neurocritical Care

A Study to Compare Non-invasive Near-infrared Spectroscopy (NIRS) to Invasive Licox Intracranial Pressure Monitoring in Neurocritical Care

Alejandro Rabinstein
All
18 years to 99 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-122549-H01-RST
19-008406
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Inclusion Criteria:

  • Adult patients 18 years or older. 
  • Patients with Glasgow coma scale score (GCS) ≤ 8
  • Patients having neuroimaging concerning for ICP crises or have active ICP treatment may undergo non-invasive NIRS monitoring and invasive LICOX intraparenchymal brain tissue oxygen monitoring once study consent is obtained.


Exclusion Criteria:

  • Patients with CNS infection.
  • Patients with bleeding diathesis or thrombocytopenia < 50,000 platelets.
  • Patients with subdural hematomas who have had surgical decompression and bone flap removal.
  • Each patient will undergo 3 to 10 days of monitoring (depending on pathology; i.e., patients with poor-grade aneurysmal subarachnoid hemorrhage may undergo longer monitoring to assess for delayed cerebral ischemia during the time window of vasospasm risk).
  • Pregnant individuals.
  • Children.
  • Prisoners.
  • Institutionalized individuals.
  • Others who are likely to be vulnerable.

 

Procedure/Surgery, Admission to neurological intensive care unit, Intracranial pressure monitoring via burr hole, Near-infrared spectroscopy, Oxygenation monitoring, Procedure for monitoring intracranial pressure
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Magnetic Resonance Spectroscopy (MRS) of 2-hydroxyglutarate (2HG) for Diagnosis and Follow-up of IDH-mutant Glioma

A Study to Evaluate Magnetic Resonance Spectroscopy Diagnosis and Follow-up of IDH-mutant Glioma

John Port
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
0000-122558-H01-RST
19-008537
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Inclusion Criteria:

  • Adult patients (age >= 18 years old).
  • Suspected WHO grade II or III infiltrating glioma based on standard MR imaging.
  • No previous tumor treatment or surgery.
  • Surgery for definitive diagnosis anticipated to occur within 3 months of study imaging.


Exclusion Criteria:
 

  • Inability to undergo MR imaging for any reason (claustrophobia, habitus, implanted devices, etc.).
  • Previous cranial surgical operations if metallic plates or grafts are near the area of tumor.
  • Predominantly ring-enhancing disease on anatomic MR.
  • Pregnancy.
Brain tumor, Cancer, Glioma
Cancer treatment, Low grade glioma of brain, MRI, Medical Oncology, Nervous system
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Standardizing Method and Development of Normal Values to Measure Human Small Intestinal and Colonic Permeability

A Study to Analyze Normal Values to Measure Human Small Intestinal and Colonic Permeability

Michael Camilleri
All
18 years to 70 years old
This study is NOT accepting healthy volunteers
0000-122560-H01-RST
19-008541
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Inclusion Criteria:

  • Healthy, non-obese participants.
  • Non-pregnant Caucasian volunteers.
  • 18-70 years old.
  • Male or female, 1:1.
  • BMI < 30kg/m2.


Exclusion Criteria:

  • Diabetes.
  • Hypertension.
  • BMI ≥ 30kg/m^2.
  • Chronic NSAID use (> 3 days/week).

 

 

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Cardiac MRE of Acute Myocardial Infarcts

A Study to Evaluate Cardiac Magnetic Resonance Elastrography (MRE) of Acute Myocardial Infarcts

Philip Araoz
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
0000-122571-H01-RST
19-008667
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Inclusion Criteria:

  • Age ≥ 18 years old.
  • New myocardial infarction within 10 days of enrollment


Exclusion Criteria:

  • Contraindications to MRI scanning including internal defibrillators or pacemakers, cerebral aneurysm clips, or severe claustrophobia.  
  • Contraindications to gadolinium-based MRI contrast material; namely, glomerular filtration rate less than or equal to 30mL/min. 
  • Patients with no serum creatinine available within 30 days will have a new serum creatinine drawn to calculate glomerular filtration rate. 
  • Women who are pregnant or lactating.

 

Heart attack
Acute myocardial infarction, Cardiac MRI, Cardiovascular system, MRI, Magnetic resonance elastography
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Symptom Assessment in Working Age Stroke Survivors: Are the most severe symptoms the most bothersome?

A Study to Assess Symptoms in Working Age Stroke Survivors

Lori Rhudy
All
18 years to 70 years old
This study is NOT accepting healthy volunteers
0000-122575-H01-RST
19-008750
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Inclusion Criteria:

  • Patients 18-70 years old.
  • Patients having ischemic stroke in the past 5 years.
  • Diagnosis of ischemic stroke when between 18 and 64 years of age.


Exclusion Criteria:

  • Patients under 18 or over 70 years of age.
Stroke
History of cerebrovascular accident due to ischemia, Ischemic stroke, Nervous system
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High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study

A Study to Evaluate Electrical Nerve Block for Amputation Pain

Peter Rhee
All
21 years and over
This study is NOT accepting healthy volunteers
0000-122576-P01-RST
19-008764
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Inclusion Criteria:

  • Subject shall have a unilateral amputated lower limb for no less than 12 months. If the amputation needed revision within 12 months, patient could be enrolled if investigator documents that the amputation site has healed and subject’s symptoms have stabilized.
  • Post-amputation pain shall be chronic (persistent over 6 months) and resistant to pain medications with a documented history within the subject’s medical records.
  • Subject shall have frequent and recurring pain defined as no less than 4 episodes of pain ≥ 5 (NRS) per week on average (to be confirmed with baseline pain diary).
  • Subject’s typical pain episode should last no less than 60 minutes.
  • Subject shall demonstrate response to two injections, one regional nerve block and the other saline. Response to the regional nerve block is defined as greater than or equal to a 50% pain reduction by NRS at 20 minutes from administration of Lidocaine. An allowable, non-therapeutic response to saline is defined as less than 30% pain reduction by NRS 15 minutes after administration. NRS must be ≥ 5 before first injection.
  • Subject’s regimen of drug therapy for pain shall be stable for no less than 4 weeks prior to implant and shall not change without approval of investigator until after their Month- 3 visit. Subject shall sign a pain medication “contract” to confirm acceptance of guidelines for the use of pain medication.
  • Subject agrees not to replace or alter their prosthetic (if applicable) until after their Month-3 (primary endpoint) visit.
  • Subject is able to independently read and complete all questionnaires provided in English and use electronic diary during study.
  • Subject is willing and able to provide informed consent and comply with all procedures and assessments required by study protocol.
  • Subject, and caregiver if applicable, is able and willing to be available for study visits throughout the duration of the study; e.g., no planned relocation of residence or extended vacation during the study that would prevent compliance with study visit schedule.
  • Subject shall be 21 years of age or older (FDA definition of non-pediatric) and legally able to provide written informed consent.


Exclusion Criteria:

  • Implanted with an active implantable medical device (i.e., pacemaker).
  • Confounding source of pain that interferes with reporting of limb pain.
  • Uncontrolled diabetes.
  • Spasticity preventing full range of motion of involved side .
  • Extremely short stump; sits on end.
  • Untreated psychological condition (i.e., borderline personality).
  • Condition requiring MRI studies or diathermy after device implant.
  • Life expectancy of less than 24 months.
  • Progressive neurological disease (i.e, multiple sclerosis).
  • Subjects with active local or systemic infection or immunocompromised.


Exclusion Criteria:

  • Subject is currently implanted with any active implantable device including but not limited to: pacemaker, implantable cardiac defibrillator, implantable neurostimulator (e.g., peripheral or spinal cord stimulator), or implantable drug pump.
  • Subject has a source of pain other than post-amputation pain (incl. dysesthesia, cancer- related, visceral, angina, migraine, causalgia) which in the opinion of the investigator may interfere with the reporting of post-amputation pain.
  • Subject has medical contraindications to surgery, including but not limited to cardiovascular, pulmonary, renal, liver or hematological disorders, active inflammation, medical contraindication for general anesthesia (e.g., severe cardiopulmonary disease), compromised immune state (due to concomitant disease or medications such as chemotherapy or immunosuppressants), or anticoagulant medication that cannot be discontinued for perioperative period.
  • Uncontrolled diabetes as defined by HbA1c > 8.0.
  • Spasticity in their residual limb such that the subject cannot achieve volitional full range of motion (ROM) of joints on involved side.
  • Subject has skin graft or severe scarring over targeted implant site or any anatomical conditions that would prevent placement of the Altius System components.
  • Subject demonstrates an inability to discern differences in pain severity, report pain intensity and related information, or complete a pain diary.
  • Subject has a suspected or known allergy to any materials of the Altius System in tissue contact or Lidocaine (necessary for injection screen).
  • Subject has received therapeutic regional nerve block (e.g., anesthetic with steroid, and/or opioids) for post-amputation pain within 30 days prior to baseline visit.
  • Subject’s usual seated posture includes sitting on the end of their stump.
  • Subject is a woman who is not using adequate contraception, is pregnant or breastfeeding, or intends to become pregnant during the course of the study.
  • Subject is currently participating or intends to participate in another investigational drug or device clinical study that may influence or interfere with the data that will be collected for this study.
  • Subject has a condition requiring MRI studies or diathermy after device implantation.
  • Subject has a history of any alcohol or substance abuse or dependence which has required prior medical treatment or intervention. Subject has active alcohol or substance abuse.
  • Subject has a condition that, in the opinion of the investigator, would interfere with study compliance (incl. unresolved issues of secondary gain) or subject’s safety.
  • Subject has a life expectancy of less than 24 months.
  • Subject is diagnosed with or has untreated psychological conditions: borderline personality disorder, major depression disorder characterized by hospitalization within the prior year for a major depressive episode.
  • Subject has current diagnosis of any progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive diabetic peripheral neuropathy, or any tumor of the nervous system.
  • Subjects with active local or systemic infection, prior recurrent bacterial infection, those who are immunocompromised or have high risk of infection due to other comorbidities.

 

Device
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Significance of Glandular Atypia in Barrett’s Esophagus Determined by Volumetric Laser Endomicroscopy

A Study to Evaluate Glandular Atypia in Barrett?s Esophagus Determined by Volumetric Laser Endomicroscopy

Cadman Leggett
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
0000-122617-H01-RST
19-008998
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Inclusion Criteria:

  • Patients with Barrett's Esophagus (BE) undergoing endoscopic surveillance.


Exclusion Criteria:

  • Patients with contraindications to endoscopic resection and/or volumetric laser endomicroscopy (VLE) imaging.

 

Barrett's esophagus
Barrett's esophagus, Digestive system, Glandular cell atypia
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Extravascular ICD Pivotal Study (EV ICD) (EV ICD)

Extravascular ICD Pivotal Study

Yongmei Cha
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122627-P01-RST
19-009083
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Inclusion Criteria:

  • Patient has a Class I or IIa indication for implantation of an ICD according to the ACC/AHA/HRS Guidelines, or ESC guidelines. 
  • Patient is at least 18 years of age and meets age requirements per local law. 
  • Patient is geographically stable and willing and able to complete the study procedures and visits for the duration of the follow-up.


Exclusion Criteria:
 

  • Patient is unwilling or unable to personally provide Informed Consent. 
  • Patient has indications for bradycardia pacing or Cardiac Resynchronization Therapy (CRT) (Class I, IIa, or IIb indication). 
  • Patient with an existing pacemaker, ICD, or CRT device implant or leads. 
  • Patients with these medical interventions are excluded from participation in the study: 
    • Prior sternotomy;
    • Any prior medical condition or procedure that leads to adhesions in the anterior mediastinal space (i.e., prior mediastinal instrumentation, mediastinitis);
    • Prior abdominal surgery in the epigastric region;
    • Planned sternotomy;
    • Prior chest radiotherapy Or any other prior/planned medical intervention not listed that precludes their participation in the opinion of the Investigator.
  • Patient has previous pericarditis that:
    • Was chronic and recurrent; or
    • Resulted in pericardial effusion; or
    • Resulted in pericardial thickening or calcification. 
  • Patients with these medical conditions or anatomies are excluded from participation in the study: 
    • Hiatal hernia that distorts mediastinal anatomy;
    • Marked sternal abnormality (e.g., pectus excavatum);
    • Decompensated heart failure;
    • COPD with oxygen dependence;
    • Gross hepatosplenomegaly.
  • Or any other known medical condition or anatomy type not listed that precludes their participation in the opinion of the Investigator.
  • Patients with a medical condition that precludes them from undergoing defibrillation testing: 
    • Severe aortic stenosis;
    • Intracardiac LA or LV thrombus;
    • Severe proximal three-vessel or left main coronary artery disease without revascularization;
    • Hemodynamic instability;
    • Unstable angina;
    • Recent stroke or transient ischemic attack (within the last 6 months);
    • Known inadequate external defibrillation; 
    • LVEF < 20%;
    • LVEDD > 70 mm.
  • Or any other known medical condition not listed that precludes their participation in the opinion of the Investigator. 
  • Patient with any evidence of active infection or undergoing treatment for an infection. 
  • Patient is contraindicated from temporary suspension of oral/systemic anticoagulation.
  • Patient with current implantation of neurostimulator or any other chronically implanted device that delivers current in the body. 
  • Patient meets ACC/AHA/HRS or ESC clinical guideline Class III criteria for an ICD (e.g., life expectancy of less than 12 months). 
  • Patient is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager. 
  • Patient with any exclusion criteria as required by local law (e.g., age or other).
  • Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence.
Device, Cardioverter defibrillator procedure
Implantable cardioverter-defibrillator (ICD) insertion
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Patient-Provider-Community Health Worker Integrated Care Model: Use of an Innovative Mobile Health Intervention to Improve Hypertension among African-Americans

A Study to Evaluate an Integrated Care Model Using Mobile Health Intervention in African American Patients with Hypertension

LaPrincess Brewer
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
0000-122642-H01-RST
19-009247
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Inclusion Criteria:

Phase 1
•App Refinement

  • Health care provider (physician, registered nurse, physician assistant) at one of the two FQHCs.
  • Patient receiving primary care at one of the two partnering FQHCs:
    • AA race/ethnicity.
    • Men and women aged ≥ 18 years old.

Phase 2
•App Implementation

  • Receiving primary care at one of the two partnering FQHCs and intent to continue care there for next 6 months.
  • AA race/ethnicity.
  • Men and women aged ≥ 18 years old.
  • Uncontrolled HTN (defined as BP ≥ 140/90 mmHg [as per JNC7 Hypertension Guidelines] at most recent outpatient evaluation, with or without BP medications).
  • Documented diagnosis of HTN in EHR.
  • At least 1 office visit at one of the two partnering FQHCs in prior year.
  • Smartphone ownership (supporting iOS or Android Systems).


Exclusion Criteria:

Phase 1

  • Unable to commit to participating in both focus groups (pre- and post-app refinement).
  • Diagnosis of a serious medical condition or disability that would make participation difficult; i.e., visual or hearing impairment, mental disability that would preclude independent use of the app.

Phase 2

  • Diagnosis of a serious medical condition or disability that would make participation difficult; i.e., visual or hearing impairment, mental disability that would preclude independent use of the app.

 

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A Phase 2 Open Label, Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Oral Contrast Agent, NX9, for the Delineation of Bowel Anatomy at CT Imaging with and without IV Contrast in Subjects with Cancer or GI Disease Typically Evaluated with CT (MVSS NXT001-19 IBD)

A Study to Evaluate the Safety and Effectiveness of NX9 for CT Imaging in Patients with Cancer or GI Disease

David Bruining
All
18 years to 85 years old
Phase 2
This study is NOT accepting healthy volunteers
0000-122693-P01-RST
19-009777
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Inclusion Criteria:

  • Understands the requirements of the study and provides written informed consent.
  • prior to undergoing any study-related procedures.
  • Subject is between the ages of 18 to 85 years old, inclusive.
  • Has had and agrees to submit the results and images of a CT that shows some disease of the bowel or disease adjacent to bowel (e.g., peritoneal disease, carcinomatosis, omental caking or bowel inflammation), such that there is a reasonably high chance that the study CT scan could also show disease and which was:
    • conducted within 6 months prior to study entry;
    • conducted with IV and either positive or neutral oral contrast.
  • Is willing and able to comply with protocol-specified CT scanning and visits to the clinic.
  • Is able to lie flat with arms above head for 15 minutes and hold breath for 15 seconds.
  • Is able to drink 1.2 liters of fluid within 45 minutes.
  • Has good venous access as determined by the Investigator at screening.
  • Is an outpatient who is able and willing to come to the clinic for study visits.


Exclusion Criteria:

 

  • Has any co-morbidity that the Investigator judges will interfere with their ability to complete the study or undergo a quality CT scan; e.g., high risk of aspiration.
  • Has a history of or is currently suffering from a known gastrointestinal motility disorder; e.g., severe constipation / gastroparesis, achalasia, pseudo-obstruction, etc.
  • Has symptoms of a possible current bowel obstruction.
  • Has a moderate to high risk of current bowel perforation.
  • Subject should not schedule a GI diagnostic surgery or hospitalization for any procedure until after the Study follow-up on Day 14 day. However, if at the time of study entry, the subject has pre-planned a surgery or hospitalization, it may be allowed at the discretion of the PI provided it does not take place until after the subject completes the Day 3 ± 2 days visit.
  • Has a contraindication (i.e. allergy) to IV or Oral CT contrast.
  • If of child-bearing potential, has a confirmed pregnancy or a high probability of pregnancy at the time of screening.
  • Has received an investigational therapeutic or diagnostic agent or been treated with an investigational device within the 30 days prior to enrollment.
Drug, CT of abdomen with contrast
Cancer
CT scan, Digestive system, Disorder of gastrointestinal tract, Malignant neoplasm of gastrointestinal tract, Medical Oncology
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HELIOS-B: A Phase 3, Randomized, Doubleblind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy)

A Study to Evaluate the Effectiveness and Safety of Vutrisiran in Patients with Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloidosis with Cardiomyopathy

Martha Grogan
All
18 years to 85 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-122704-P01-RST
19-009925
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Inclusion Criteria:

  • Age 18 (or age of legal consent per local regulations, whichever is older) to 85 years, inclusive.
  • Documented diagnosis of ATTR amyloidosis with cardiomyopathy, classified as either hATTR amyloidosis with cardiomyopathy or wtATTR amyloidosis with cardiomyopathy:
    • Hereditary ATTR (hATTR) amyloidosis with cardiomyopathy diagnosed based on meeting all of the following criteria:
    • Documentation of a TTR pathogenic mutation consistent with hATTR amyloidosis;
    • Evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness > 12 mm (based on central echocardiogram reading at Screening);
    • Amyloid deposits in cardiac or noncardiac tissue (e.g., fat pad aspirate, salivary gland, median nerve connective sheath) confirmed by Congo Red (or equivalent) staining OR technetium (99mTc) scintigraphy (99mTc-3,3-diphosphono-1,2- propanodicarboxylic acid [DPD-Tc], 99mTc-pyrophosphate [PYP-Tc] or 99Tchydroxymethylene diphosphonate [HMDP]) with Grade 2 or 3 cardiac uptake, if monoclonal gammopathy of undetermined significance (MGUS) has been excluded;
    • If the patient has evidence of a MGUS based on serum and urine protein electrophoresis and serum free light chains,  documentation of TTR protein in tissue with immunohistochemistry or mass spectrometry is required.
    • Wild-type ATTR (wtATTR) amyloidosis with cardiomyopathy diagnosed based on meeting all of the following criteria:
      • Documentation of absence of pathogenic TTR mutation;
      • Evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness > 12mm (based on central echocardiogram reading at Screening);
      • Amyloid deposits in cardiac tissue with TTR protein identification by IHC, mass spectrometry, OR technetium (99mTc) scintigraphy (99mTc-3,3-diphosphono-1,2- propanodicarboxylic acid [DPD-Tc], 99mTc-pyrophosphate [PYP-Tc], or 99Tchydroxymethylene diphosphonate [HMDP]) with Grade 2 or 3 cardiac uptake, if MGUS has been excluded;
      • If the patient has evidence of a MGUS based on serum and urine protein electrophoresis and serum free light chains, the following is required: documentation of TTR protein in cardiac tissue with immunohistochemistry or mass spectrometry OR documentation of TTR protein in noncardiac tissue (e.g., fat pad aspirate, salivary gland, median nerve connective sheath) with immunohistochemistry or mass spectrometry; AND Grade 2 or 3 cardiac uptake on technetium scintigraphy.
  • Medical history of HF with at least 1 prior hospitalization for HF (not due to arrhythmia or a conduction system disturbance treated with a permanent pacemaker) OR clinical evidence of HF (with or without hospitalization) manifested by signs and symptoms of volume overload or elevated intracardiac pressures (e.g., elevated jugular venous pressure, shortness of breath or signs of pulmonary congestion on x-ray or auscultation, peripheral edema) that currently requires treatment with a diuretic.
  • Patient meets one of the following criteria: a. Tafamidis-naïve and not actively planning to commence treatment with tafamidis during the first 12 months following randomization.
    • Note: in addition to patients who have never taken tafamidis, those who have previously been on tafamidis and have not received any tafamidis for at least 30 days before the Screening Visit will be considered tafamidis-naïve for purposes of this study); or
    • On tafamidis.  Note: must be on-label use of commercial tafamidis per an approved cardiomyopathy indication and dose in the country of use.
  • Patient is clinically stable, with no CV-related hospitalizations within 6 weeks prior to randomization, as assessed by the Investigator.
  • Screening NT-proBNP > 300 ng/L and 600 ng/L and < 8500 ng/L.
  • Able to complete ≥ 150 meters on the 6-MWT at Screening.
  • Have a Karnofsky performance status of ≥ 60%


Exclusion Criteria:

  • Has known primary amyloidosis (AL amyloidosis) or leptomeningeal amyloidosis.
  • NYHA Class IV heart failure; or NYHA Class III heart failure AND ATTR Amyloidosis Disease Stage 3 (defined as NT-proBNP > 3000 ng/L and eGFR < 45 ml/min).[Gillmore 2018].
  • Has a polyneuropathy disability (PND) Score IIIa, IIIb, or IV (requires cane or stick to walk due to polyneuropathy, or is wheelchair bound) at the Screening visit.
  • Has any of the following laboratory parameter assessments at Screening:
    • AST or ALT levels > 2.0 × ULN;
    • Total bilirubin > 2.0 × ULN;
    • International normalized ratio (INR) > 1.5 (unless patients were on anticoagulant therapy in which case excluded if INR ˃ 3.5).
  • Has eGFR < 30 mL/min/1.73 m^2 (using the modification of diet in renal disease [MDRD] formula) at Screening.
  • Has known human immunodeficiency virus infection; or evidence of current or chronic hepatitis C virus or hepatitis B virus infection.
  • Tafamidis-naïve patients for whom the Investigator actively plans or anticipates commencing treatment with tafamidis either during the Screening Period or the first 12 months following randomization, taking into consideration clinical status, patient preference and/or commercial availability of tafamidis.
  • Received prior TTR-lowering treatment (including revusiran, patisiran or inotersen) or participated in a gene therapy trial for hATTR amyloidosis.
  • Is currently taking diflunisal; if previously on this agent, must have at least a 30-day wash-out prior to dosing (Day 1).
  • Is currently taking doxycycline, ursodeoxycholic acid, or tauroursodeoxycholic acid; if previously on any of these agents, must have completed a 30-day wash-out prior to dosing (Day 1).
  • Unwilling to avoid any concurrent treatment with diflunisal, ursodeoxycholic acid/tauroursodeoxycholate/doxycycline, or TTR lowering agents (e.g., patisiran, inotersen)
  • Current or future participation in another investigational device or drug study, scheduled to occur during this study, or has received an investigational agent or device within 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to dosing (Day 1). In the case of investigational TTR stabilizer drugs, washout for 3 months prior to dosing (Day 1) is required; this does not apply to patients who are on tafamidis at baseline.
  • Requires treatment with or is unwilling to avoid any concurrent treatment with nondihydropyridine calcium channel blockers (e.g., verapamil, diltiazem).
  • 30 days (or 5 half-lives of the investigational drug, whichever is longer) prior to dosing (Day 1). In the case of investigational TTR stabilizer drugs, washout for 3 months prior to dosing (Day 1) is required; this does not apply to patients who are on tafamidis at baseline.
  • Requires treatment with or is unwilling to avoid any concurrent treatment with nondihydropyridine calcium channel blockers (e.g., verapamil, diltiazem).
  • Other non-TTR cardiomyopathy, hypertensive cardiomyopathy, cardiomyopathy due to valvular heart disease, or cardiomyopathy due to ischemic heart disease (e.g., prior myocardial infarction with documented history of cardiac enzymes and ECG changes) that the Investigator feels is a significant contributor or the predominant cause of the patient’s heart failure.
  • Unstable congestive heart failure (CHF) (including patients who require adjustment of existing diuretics or addition of new diuretics at time of Screening for purposes of achieving optimal management of CHF).
  • Had acute coronary syndrome or unstable angina within the past 3 months.
  • Has history of sustained ventricular tachycardia or aborted ventricular fibrillation.
  • Has history of atrioventricular nodal or sinoatrial nodal dysfunction for which a pacemaker is indicated but will not be placed.
  • Has persistent elevation of systolic (˃ 170 mmHg) or diastolic (˃ 100 mmHg) blood pressure that is considered uncontrolled by physician.
  • Has untreated hypo- or hyperthyroidism.
  • Has an active infection requiring systemic antiviral, antiparasitic or antimicrobial therapy that will not be completed prior to dosing (Day 1).
  • Prior or anticipated (during the first 12 months after randomization) heart, liver or other organ transplant or implantation of left-ventricular assist device.
  • History of multiple drug allergies or history of allergic reaction to any component of or excipient in the study drug.
  • History of intolerance to SC injection(s) or significant abdominal scarring that could potentially hinder study drug administration or evaluation of local tolerability.
  • Has other medical conditions or comorbidities (e.g., malignancy, neuropsychiatric disorder etc…) which, in the opinion of the Investigator, would interfere with study compliance or data interpretation.
  • Is not willing to comply with the contraceptive requirements during the study period.
  • Female patient is pregnant, planning a pregnancy, or breast-feeding.
  • Unwilling or unable to limit alcohol consumption throughout the course of the study. Alcohol intake of > 2 units/day is excluded during the study (unit: 1 glass of wine [approximately 125 mL] = 1 measure of spirits [approximately 1 fluid ounce] = ½ pint of beer [approximately 284 mL]).
  • History of alcohol abuse, within the last 12 months before Screening, in the opinion of the Investigator.
  • History of illicit drug abuse within the past 5 years that in the opinion of the Investigator would interfere with compliance with study procedures or follow-up visits.
Drug, Other
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The Assessment of Carotid Blood Velocity Using Continuous Wave Doppler during Lower Body Negative Pressure

A Study to Assess Carotid Blood Velocity Using Continuous Wave Doppler during Lower Body Negative Pressure

Bruce Johnson
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122730-P01-RST
19-010136
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Inclusion Criteria:

  • 15 healthy individuals aged ≥ 18 years.
  • No history of cardiovascular diseases.
  • Current non-smokers.
  • All subjects will be informed about the study and consented prior to participation


Exclusion Criteria:

  • Subjects with a history of more significant hypotension (SBP < 90mmHg).
  • Subjects who are morbidly obese (BMI > 38).

 

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An Open-label Study to Evaluate the Long-term Safety of Daily Oral BCX7353 in Subjects With Type I and II Hereditary Angioedema (APeX-S)

A Long Term Safety Study of BCX7353 in Hereditary Angioedema

Thanai Pongdee
All
12 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-122737-P01-RST
19-010175
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Inclusion Criteria:
 

  • Subjects with HAE Type I or II who either have participated in a previous BCX7353 study or, in selected countries, in the opinion of the Investigator are expected to derive benefit from an oral treatment for the prevention of angioedema attacks. 
  • Access to appropriate medication for treatment of acute attacks.
  • Acceptable effective contraception.
  • Written informed consent.


Exclusion Criteria:
 

  • Pregnancy or breast-feeding.
  • Any clinically significant medical condition or medical history that, in the opinion of the Investigator or Sponsor, would interfere with the subject's safety or ability to participate in the study.
  • Any laboratory parameter abnormality that, in the opinion of the Investigator, is clinically significant and relevant for this study.
  • Discontinuation of study drug due to a hypersensitivity reaction BCX7353 in a prior study.
  • Severe hypersensitivity to multiple medicinal products or severe hypersensitivity/ anaphylaxis with unclear etiology.
  • Unacceptable noncompliance in a previous BCX7353 study (if applicable) as assessed by the Sponsor or Investigator.
  • Investigational drug exposure, other than BCX7353, within 30 days prior to the screening visit (or baseline if no screening visit).
Drug
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Using a Wearable Sensor as an Alternative to Marker-based Motion Capture for Studying Baseball Pitching

A Study to Evaluate A Wearable Sensor to Study Baseball Pitching

Christopher Camp
Male
15 years to 30 years old
This study is NOT accepting healthy volunteers
0000-122750-H01-RST
19-010255
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Inclusion Criteria:

  • Age 15-30 years, inclusive.
  • Male gender.
  • Active participation in competitive baseball as a pitcher.Should be competing at the high school or collegiate level.
  • No current musculoskeletal complaints for which the subject is being treated.
  • Full pain-free range of motion (ROM) of the bilateral upper and lower limbs.
  • Willingness to participate in the study


Exclusion Criteria:
 

  • Current upper limb, lower limb, or spine musculoskeletal pain complaint for which the subject is taking prescribed medication, has modified activity, or received treatment from a medical care provider.
  • History of fracture, dislocation, subluxation, or separation affecting the cervical spine, thoracic spine, rib cage, elbow, or either shoulder girdle.
  • History of rotator cuff injury, elbow injury, or shoulder instability for which the subject has been evaluated and/or treated in the past 12 months.
  • History of dominant side shoulder or elbow surgery.
  • Known neurological, visual, or vestibular disease affecting balance or coordination
  • Congenital deformity of the neck, upper extremity, or lower extremity.
  • Congenital or acquired scoliosis or significant thoracic kyphosis (> 30 degrees).
  • History of connective tissue disease (defined as rheumatoid arthritis, systemic lupus erythematosus, or a seronegative spondylarthropathy).

 

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Mayo Clinic — Rochester, MN

Clinical Protocol for Emergency Department Treatment Study Jaspr Randomized Controlled Trial (Jaspr)

A Study to Evaluate Jaspr Application Compared to Care As Usual (CAU) in Emergency Department

Gabrielle Melin
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-122825-P01-RST
19-010319
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Inclusion Criteria:

  • Currently in the ED seeking treatment for suicidal behavior.
  • Medically and clinically stable, as deemed by ED medical personnel/patient’s care team.
  • Access to a computer or other device (smartphone, tablet) with Internet connection.
  • Currently has and regularly uses an Apple or Android smartphone.
  • Stable address and housing for the last 30 days.

Exclusion Criteria:

  • Acutely psychotic, severely agitated, and patients with significant intoxication or other impairment (as deemed by medical providers) that may interfere with providing consent and meaningful feedback (as determined by their care team).
  • No access or way to access phone or computer (or other device) with Internet connection.
  • homeless or unstable housing in the past 30 days.
  • Severely agitated patients are those who are perceived by medical personnel as highly distressed and likely to become more agitated (e.g., yelling, throwing objects, engaging in self-harming behaviors) and/or distressed if approached by medical personnel and/or research staff about research-related activities, from inquiring about their interest to participate and obtaining informed consent to providing feedback to researchers.
Behavioral, Other, Assessment for suicidality, Education about suicide prevention smartphone application, Emergency treatment
Suicidal behavior
Suicidal behavior
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A Randomized Double-blind Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Estetrol for the Treatment of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women (E4Comfort Study II) (E4Comfort)

A Study to Evaluate Estetrol to Treat Moderate-to-Severe Vasomotor Symptoms in Postmenopausal Women

Ekta Kapoor
Female
40 years to 65 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-122827-P01-RST
19-010338
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Inclusion Criteria:

  • Signed and dated written informed consent form and any required privacy authorization prior to the initiation of any trial procedure, after the nature of the trial has been explained according to local regulatory requirements.
  • Females ≥ 40 up to ≤ 65 years of age at randomization.
  • For hysterectomized subjects: documented hysterectomy must have occurred at least 6 weeks prior to the start of screening. Hysterectomy can be total or subtotal (i.e., cervix was not removed).
  • For non-hysterectomized subjects: uterus with bi-layer endometrial thickness ≤ 4 mm on TVUS (Amendment 3, 08 October 2019 and Amendment 4, 03 February 2020).
  • For non-hysterectomized subjects: endometrial biopsy taken during screening that reveals no abnormal results; i.e., presence of hyperplasia (simple or complex, with or without atypia), presence of carcinoma, and presence of disordered proliferative findings. The screening biopsy should have sufficient endometrial tissue for diagnosis. Biopsies without tissue or with insufficient tissue may be repeated once.
  • Seeking treatment for relief of VMS associated with menopause:
    • For the Efficacy Study part: at least 7 moderate to severe bothersome VMS per day or at least 50 moderate to severe bothersome VMS per week in the last 7 consecutive days during the Screening period;
    • For the Safety Study part: at least 1 moderate to severe VMS per week.
  • Body mass index ≥ 18.0 kg/m² to ≤ 38.0 kg/m².
  • A mammogram that shows no sign of significant disease performed during screening or within 9 months prior to the start of screening.*
  • Post-menopausal status defined as any of the following:
  • For non-hysterectomized subjects:
    • or at least 6 weeks postsurgical bilateral oophorectomy;
    • or at least 6 months of spontaneous amenorrhea with serum FSH > 40 mIU /mL and E2 < 20 pg/mL (value obtained after washout of estrogen/progestin containing drugs;
    • or at least 6 weeks postsurgical bilateral oophorectomy.
  • For hysterectomized subjects:
    • serum FSH > 40 mIU/mL and E2 < 20 pg/mL (values obtained after washout of estrogen/progestin containing drug;
    • or at least 6 weeks post-surgical bilateral oophorectomy.
  • Good physical and mental health, in the judgement of the Investigator as based on medical history, physical and gynecological examination, and clinical assessments performed prior to Visit 1.
  • Able to understand and comply with the protocol requirements, instructions, and protocol-stated restrictions.
  • Able and willing to complete trial daily diaries and questionnaires.

* Subjects must have a Breast Imaging-Reporting And Data System (BI-RADS) score of 1 or 2 to enroll in the study. An incomplete mammogram result, i.e., BI-RADS 0, is not acceptable. and requires further assessment (Amendment 5, 23 September, 2020). The site must obtain a copy of the official report for the subject's study file. A digitalized imaging should be obtained if mammography is done as part of this study.


Exclusion Criteria:

  • History of malignancy with the exception of basal cell or squamous cell carcinoma of the skin if diagnosed more than 1 year prior to the Screening visit.
  • Any clinically significant findings found by the Investigator at the breast examination and/or on mammography suspicious of breast malignancy that would require additional clinical testing to rule out breast cancer (however, simple cysts confirmed by ultrasound are allowed).
  • Papanicolaou (PAP) test with atypical squamous cells undetermined significance (ASC-US) or higher (low-grade intraepithelial lesion [LSIL], atypical squamous cells- cannot exclude high-grade squamous intraepithelial lesion [HSIL] [ASC-H], HSIL dysplastic or malignant cells) in sub-totally hysterectomized and non-hysterectomized subjects.
    • Note: ASC-US is allowed if a reflex human papilloma virus (HPV) testing is performed and is negative for high risk oncogene HPV.
  • For non-hysterectomized subjects:
    • History or presence of uterine cancer, endometrial hyperplasia, disordered proliferative findings;
    • Presence of endometrial polyp;
    • Undiagnosed vaginal bleeding;
    • Endometrial ablation;
    • Enlarged uterus with myoma.
  • Systolic blood pressure (BP) higher than 130 mmHg, diastolic BP higher than 80 mmHg during screening.
  • History of venous or arterial thromboembolic disease (e.g., superficial or deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, angina pectoris, etc.), or first degree family history of venous thromboembolism (VTE).
  • History of known acquired of congenital coagulopathy or abnormal coagulation factors, including known thrombophilias.
  • Diabetes mellitus with poor glycemic control in the last 6 months assessed by laboratory values of fasting glucose outside the normal ranges and glycated hemoglobin above 7%.
  • Dyslipoproteinaemia (LDL > 190 mg/dL and triglycerides > 300 mg/dL).
  • Smoking:
    • Efficacy Study part: subjects smoking > 5 cigarettes per day or > 2 packs per week;
    • Safety Study part: subjects smoking > 15 cigarettes per day or > 6 packs per week.
  • Presence or history of gallbladder disease, unless cholecystectomy has been performed.
  • Systemic lupus erythematosus.
  • Any malabsorption disorders including gastric by-pass surgery.
  • History of acute liver disease in the preceding 12 months before the start of screening or presence of chronic liver disease [alanine transaminase (ALT) or aspartate transaminase (AST) >2 x upper limit of normal (ULN), bilirubin >1.5 ULN].
  • Chronic or current acute renal impairment (estimated glomerular filtration rate <60 ml/min).
  • Porphyria.
  • Diagnosis or treatment of major psychiatric disorder (e.g., schizophrenia, bipolar disorder, etc.) in the judgement of the Investigator.
  • Use of estrogen/progestin containing drug(s) up to:
    • 1 week before screening start for vaginal non systemic hormonal products (rings, creams, gels).
    • 4 weeks before screening start for vaginal or transdermal estrogen or estrogen/progestin products.
    • 8 weeks before screening start for oral estrogen and/or progestin products and/or selective estrogen receptor modulator therapy.
    • 8 weeks before screening start for intrauterine progestin therapy.
    • 3 months before screening start for progestin implants or estrogen alone injectable drug therapy.
    • 6 months before screening start for estrogen pellet therapy or progestin injectable drug therapy.
    • Use of androgen/ dehydroepiandrosterone (DHEA) containing drugs:
      • 8 weeks before screening start for oral, topical, vaginal or transdermal androgen;
      • 6 months before screening start for implantable or injectable androgen therapy.
  • Use of phytoestrogens or black cohosh for treatment of VMS up to 2 weeks before the start of screening.
  • For the women participating in the Efficacy Study part: use of prescription or over-the-counter products used for the treatment of VMS; e.g., anti-depressants: paroxetine, escitalopram, methyldopa, opioid and clonidine up to 4 weeks before the start of screening, and venlafaxine and desvenlafaxine up to 3 months before the start of screening , and not willing to stop these during their participation in the trial.
  • Inadequately treated hyperthyroidism at screening.
  • History or presence of allergy/intolerance to the investigational product or drugs of this class or any component of it, or history of drug or other allergy that, in the opinion of the Investigator contraindicates subject participation.
  • For non-hysterectomized subjects: history or presence of allergy to peanuts.
  • History of alcohol or substance abuse (including marijuana, even if legally allowed) or dependence in the previous 12 months before the start of screening as determined by the Investigator, based on reported observations.
  • Sponsor or contract research organization (CRO) employees or employees under the direct supervision of the Investigator and/or involved directly in the trial.
  • Subjects with known or suspected history of a clinically significant systemic disease, unstable medical disorders, life-threatening disease or current malignancies that would pose a risk to the subject in the opinion of the Investigator.
  • Participation in another investigational drug clinical trial within 1 month (30 days) or having received an investigational drug within the last 1 month (30 days) before the start of screening.
  • Is judged by the Investigator to be unsuitable for any reason.

 

Drug, Other, Drug therapy
Abnormal vasomotor function, Estetrol [USAN], Menopausal and postmenopausal disorders, Postmenopausal state, Reproductive system
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Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients with Rare Genetic Disorders of Obesity

A Study to Evaluate Setmelanoitide to Treat Patients with Rare Genetic Disorders of Obesity

Andres Acosta
All
6 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-122836-P01-RST
19-010422
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Inclusion Criteria:

Patients with the following genotypes and/or clinical diagnosis:

  • POMC/PCSK1/LEPR heterozygous;
  • POMC/PCSK1/LEPR compound heterozygous (two different mutations in gene) or homozygous deficiency obesity;
  • POMC/PCSK1/LEPR composite heterozygous (two or more mutations in two or more genes) deficiency obesity;
  • Smith-Magenis Syndrome (SMS);
  • SH2B1 deficiency obesity;
  • Chromosomal rearrangement of the 16p11.2 locus causing obesity;
  • CPE compound heterozygous or homozygous deficiency obesity;
  • Leptin deficiency obesity with loss of response to metreleptin;
  • SRC1 deficiency obesity;
  • MC4R deficiency obesity;
    • Note: The specific genotype for all patients must be reviewed by the Sponsor prior to study enrollment to confirm that the patient meets Inclusion Criterion #1. In addition, enrollment of patients in some subgroups may be prioritized by the Sponsor in order to ensure enrollment of patients with (1) well described, loss of function genetic mutations, (2) a variety of genetic variants, or (3) genetic variants likely to respond to setmelanotide.
  • Age 6 years and above.
  • Obese, defined as Body Mass Index (BMI) ≥ 30 kg/m^2 for patients ≥ 16 years of age or BMI ≥ 95th percentile for age and gender for patients 6 up to 16 years of age.
  • Study participant and/or parent or guardian is able to communicate well with the Investigator, to understand and comply with the requirements of the study, and is able to understand and sign the written informed consent/assent.
  • Female participants of child-bearing potential must be confirmed non-pregnant, and agree to use contraception as outlined in the protocol. Female participants of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation), post-menopausal for at least 12 months (and confirmed with a screening Follicle Stimulating Hormone [FSH] level in the post-menopausal lab range), and failure to have achieved menarche, do not require contraception during the study.
  • Female participants of child-bearing potential must be confirmed non-pregnant, and agree to use contraception as outlined in the protocol. Female participants of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation), post-menopausal for at least 12 months (and confirmed with a screening Follicle Stimulating Hormone [FSH] level in the post-menopausal lab range), and failure to have achieved menarche, do not require contraception during the study.
  • Male participants with female partners of childbearing potential must agree to a double-barrier method if they become sexually active during the study. Male patients must not donate sperm during and for 90 days following their participation in the study.


Exclusion Criteria:

  • Recent intensive (within 2 months) diet and/or exercise regimen with or without the use of weight loss agents including herbal medications that has resulted in > 2% weight loss.
  • Use of any medication that is approved to treat obesity within three months of first dose of study drug (e.g., orlistat, lorcaserin, phentermine-topiramate, naltrexone-bupropion).Note: Glucagon-like peptide-1 (GLP-1) receptor agonists may be used up to the dose  approved for the treatment of diabetes mellitus (e.g., liraglutide up to a daily dose of 1.8 mg) as long as:
    • is it not being prescribed for the treatment of obesity;
    • the dose has been stable for at least three months prior to enrollmen;
    • the patient has not experienced weight loss during the previous three months; AND
    • the patient intends to keep the dose stable throughout the course of the study.
  • Gastric bypass surgery within the previous six months or any prior gastric bypass surgery resulting in > 10% weight loss durably maintained from the baseline pre-operative weight  with no evidence of weight regain. Specifically, patients may be considered if surgery was  not successful, or resulted in < 10% weight loss compared to pre-operative baseline weight or clear evidence of weight regain after an initial response to bariatric surgery. All patients with a history of bariatric surgery must be discussed with and receive approval from the Sponsor prior to enrollment.
    • Note: Patients who are unable to complete the PHQ-9 or C-SSRS due to significant neurocognitive defects may be enrolled in the study, as long as in the opinion of the Primary Investigator there are no clinical signs or symptoms of suicidal behavior.
  • Current, clinically significant pulmonary, cardiac, or oncologic disease considered severe enough to interfere with the study and/or confound the results. Any patient with a potentially clinically significant disease should be reviewed with the Sponsor to determine eligibility.
  • HbA1c > 9.0% at Screening
  • .Diagnosis of schizophrenia, bipolar disorder, personality disorder, or other psychiatric disorder(s) that the Investigator believes will interfere significantly with study compliance. Neurocognitive disorders affecting ability to consent will not be disqualifying as long as an appropriate guardian able to give consent has been appointed.
  • A PHQ-9 score of ≥ 15 or any suicidal ideation of type 4 or 5 on the C-SSRS during Screening, any lifetime history of a suicide attempt, or any suicidal behavior in the last month.
  • History of significant liver disease or abnormal liver tests on Screening (i.e., > 1.5 x upper limit of normal [ULN] for alanine transaminase [ALT], aspartate transaminase [AST], alkaline phosphatase, or serum bilirubin).
    • Note: Patients entering the study with SRC1 haploinsufficiency obesity must be evaluated during the Screening Period for hepatic fibrosis by appropriate imaging techniques (e.g., transient elastography or magnetic resonance elastography). Any patient with moderate or greater fibrosis (e.g., the equivalent of a METAVIR score ≥ 2) will be excluded from the study.
    • Note: A patient with a diagnosis of non-alcoholic fatty liver disease (NAFLD) or non- alcoholic steatohepatitis (NASH) may be allowed to enroll in the study, after consultation with the Sponsor. Other significant liver disease, such as cirrhosis, are exclusionary.
  • Glomerular filtration rate (GFR) < 30 mL/min at Screening.
  • History or close family history (parents or siblings) of skin cancer or melanoma (not   including non-invasive/infiltrative basal or squamous cell lesion), or patient history of ocular- cutaneous albinism.
  • Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion), determined as part of a comprehensive skin evaluation performed by a qualified dermatologist during Screening. Any concerning lesions identified during the Screening Period will be biopsied and results known  to be benign prior to enrollment. If the pre-treatment biopsy results are of concern, the patient may need to be excluded from the study.
  • Patient is, in the opinion of the Study Investigator, not suitable to participate in the study.
  • Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing.
  • Patients previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide.
  • Significant hypersensitivity to any excipient in the study drug.
  • Inability to comply with QD injection regimen.
  • Females who are breastfeeding or nursing.
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Clinical Assessment of an Intact Parathyroid Hormone Assay Under Development by Ortho Clinical Diagnostics - (MVSS study OCD017-19 IPTH)

A Study to Assess an Intact Parathyroid Hormone Assay Under Development by Ortho Clinical Diagnostics

Bart Clarke
All
21 years and over
This study is NOT accepting healthy volunteers
0000-122862-P01-RST
19-010733
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Inclusion Criteria
•Patients Undergoing Parathyroidectomy:

  • ≥ 21 years of age
  • Undergoing first parathyroidectomy procedure.
  • Able to provide a minimum of 10 mL blood per collection timepoint, with a maximum of 20 mL blood per collection timepoint.

Exclusion Criteria
•Patients Undergoing Parathyroidectomy:

  • Known HIV or Hepatitis C infection.

Inclusion Criteria
•Patients with Hypoparathyroidism:

  • ≥ 21 years of age.
  • Clinical diagnosis of Hypoparathyroidism.
  • Able to provide a minimum of 10 mL blood with a maximum of 70 mL blood.

Exclusion Criteria - Patients with Hypoparathyroidism:

  • Known HIV or Hepatitis C infection.
  • Treatment with NATPARA < 18 hours prior to study blood collection.

Inclusion Criteria
•Patients with Primary Hyperparathyroidism:

  • ≥ 21 years of age.
  • Clinical diagnosis of Primary Hyperparathyroidism.
  • Able to provide a minimum of 10 mL blood with a maximum of 70 mL blood.

Exclusion Criteria - Patients with Primary Hyperparathyroidism:

  • Known HIV or Hepatitis C infection.

Inclusion Criteria
•Patients with Secondary Hyperparathyroidism:

  • ≥ 21 years of age.
  • eGFR of less than 20 mL/min/1.73 m^2 (can be from Standard of Care result).
  • Clinical diagnosis of Secondary Hyperparathyroidism.
  • Able to provide a minimum of 10 mL blood with a maximum of 70 mL blood.

Exclusion Criteria
•Patients with Secondary Hyperparathyroidism:

  • Known HIV or Hepatitis C infection.

Inclusion Criteria
•Patients with Hypercalcemia from Malignancy:

  • ≥ 21 years of age.
  • Calcium level of 10.3 mg/dL or higher (can be from recent Calcium result).
  • Clinical diagnosis of Hypercalcemia resulting from malignancy.
  • Able to provide a minimum of 10 mL blood with a maximum of 70 mL blood.

Exclusion Criteria
•Patients with Hypercalcemia from Malignancy:

  • Known HIV or Hepatitis C infection.
  • Treatment with calcitonin.
  • Treatment with bisphosphonates (zoledronic acid, pamidronate) or Denosumab > 3 hours prior to study blood collection.

Inclusion Criteria
•Patients with Tertiary Hyperparathyroidism:

  • ≥ 21 years of age.
  • Clinical diagnosis of Tertiary Hyperparathyroidism.
  • Able to provide a minimum of 10 mL blood with a maximum of 70 mL blood.

Exclusion Criteria
•Patients with Tertiary Hyperparathyroidism:

  • Known HIV or Hepatitis C infection.

 

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Evaluate the Effect of 1,25-Dihydroxyvitamin D3 Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons (KUMAR2)

A Study to Evaluate the Effect of 1,25-Dihydroxyvitamin D3 to Treat Insulin Secretion and Muscle Strength in Pre-diabetics

Rajiv Kumar
All
20 years to 45 years old
This study is NOT accepting healthy volunteers
0000-122879-H01-RST
19-010890
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Inclusion Criteria:

  • Adults, 20
    •45 years old, inclusive.
  • Body mass index (BMI) of > 24 kg/m^2.
  • Fasting serum glucose < 126 mg/dl.


Exclusion Criteria:

  • BMI ≤ 24 kg/m^2.
  • Fasting serum glucose ≥ 126 mg/dl.
  • Currently taking calcium and/or vitamin D supplements and unwilling to stop for study duration.
  • Serum total calcium > 10.2 mg/dL.
  • Serum inorganic phosphorus > 4.5 mg/dL.
  • Pregnancy or breastfeeding.
  • Diagnosis of Diabetes Mellitus.
  • Diagnosis of Rheumatoid Arthritis.
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
  • Renal insufficiency/failure (serum creatinine >1.5 mg/dl men; >1.3 mg/dl women).
  • Chronic active liver disease (bilirubin > 1.2 mg/dL, AST > 144 IU/L, or ALT > 165 IU/L).
  • History of chronic hepatitis.
  • History of depression, anxiety or psychiatric disease.
  • Active coronary artery disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment).
  • Oral warfarin or history of blood clotting disorders.
  • Platelet count < 100,000 per uL within the last 7 days.
  • Alcohol consumption greater than 2 glasses/day or other substance abuse.
  • Untreated or uncontrolled thyroid disorders (outside a TSH range of 0.5 to 10 mIU/L).
  • Debilitating chronic disease (at the discretion of the investigators).
  • The presence of infections, highly communicable diseases (AIDS, active tuberculosis, venereal disease, hepatitis).
  • Any malignancy.

 

 

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A Phase 3, Multicenter, Randomized, Double-blind Study of the Efficacy and Safety of Rezafungin for Injection vs. Intravenous Caspofungin Followed by Oral Fluconazole Step Down in the Treatment of Subjects With Candidemia and/or Invasive Candidiasis (ReSTORE)

Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis

Paschalis Vergidis
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-122880-P01-RST
19-010893
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Inclusion Criteria:

  • Willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally acceptable representative must provide informed consent on his/her behalf.
  • Males or females ≥ 18 years of age.
  • Established mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken ≤ 4 days (96 hours) before randomization defined as:
    • ≥ 1 blood culture positive for yeast or Candida; OR
    • Positive test for Candida from a Sponsor-approved rapid IVD; OR
    • Positive gram stain (or other method of direct microscopy) for yeast or positive culture for Candida spp. from a specimen obtained from a normally sterile site.
  • Presence of one or more systemic signs attributable to candidemia or invasive candidiasis appearing from ≤ 12 hours prior to the qualifying positive culture through time of randomization.
  • Willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required.
  • Female subjects of childbearing potential (all female subjects between 18 years < 2 years post-menopausal unless surgically sterile) must agree to and comply with using one barrier method (e.g., female condom with spermicide) plus one other highly effective method of birth control, or sexual abstinence while participating in this study. Male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception, and also agree not to donate sperm while participating in the study and for 90 days thereafter (and at least 120 days from the last dose of study drug).
  • For Candidemia only subjects, drawing of a set of blood cultures within 12 hours prior to randomization in the study. The result of these blood cultures is not required for inclusion in the study.


Exclusion Criteria:

  • Any of the following forms of invasive candidiasis at baseline:
    • Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed;
    • Osteomyelitis;
    • Endocarditis or myocarditis;
    • Meningitis, endophthalmitis, chorioretinitis, or any central nervous system infection;
    • Chronic disseminated candidiasis;
    • Urinary tract candidiasis due to ascending Candida infection secondary to obstruction or surgical instrumentation of the urinary tract. 
  • Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia for > 48 hours (e.g., > 2 doses of a once daily antifungal agent or > 4 doses of a twice daily antifungal agent) ≤ 4 days (96 hours) before randomization.
    • Exception: Receipt of antifungal therapy to which any Candida spp. isolated in culture is not susceptible.
  • Alanine aminotransferase or aspartate aminotransferase levels > 10-fold the upper limit of norma.
  • Severe hepatic impairment in subjects with a history of chronic cirrhosis (Child-Pugh score > 9).
  • Presence of an indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained and is likely to be the source of candidemia or invasive candidiasis.
  • Known hypersensitivity to Rezafungin for Injection, caspofungin, any echinocandin, or to any of their excipients.
  • Meets National Cancer Institute Common Terminology Criteria for Adverse Events, version 5, criteria for ataxia, tremor, motor neuropathy, or sensory neuropathy of Grade 2 or higher.
  • History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's Disease or Huntington's Disease).
  • Planned or ongoing therapy at Screening with a known neurotoxic medication.
  • Previous participation in this or any previous rezafungin study.
  • Current participation in another interventional treatment trial with an investigational agent.
  • Recent use of an investigational medicinal product within 28 days of the first dose of study drug or presence of an investigational device at the time of screening.
  • Pregnant or lactating females.
  • The Principal Investigator (PI) is of the opinion the subject should not participate in the study
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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus-Host Disease in Subjects Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation

Hassan Alkhateeb
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-122882-P01-RST
19-010948
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Inclusion Criteria:

  • Must be ≥ 18 years of age and, in selected countries, adolescents aged 12 years and greater and weighing ≥ 30 kilogram (kg) at time of randomization.
  • Must undergo deoxyribose nucleic acid (DNA)-based human leukocyte antigen (HLA) matching and be 8 of 8 or 7 of 8 HLA-matched (singe allele or antigen mismatch at HLA-A, -B, and -C, and HLA-DRB1 is allowable) unrelated hematopoietic stem cell transplantation (HSCT) from either peripheral blood or bone marrow stem cells for a hematologic malignancy or myeloproliferative disorder.
  • For whom a myeloablative conditioning or reduced intensity conditioning (RIC) is planned.
  • Allo-HSCT eligible (meeting institutional criteria)-participants planned medical care should include aGvHD prophylaxis with a combination of calcineurin inhibitor (CNI) (cyclosporine [CYS] or tacrolimus [TAC]) and methotrexate (MTX) or CNI and mycophenolate mofetil (MMF). With the exception of antithymocyte globulin (ATG) (antithymocyte globulin-Fresenius [ATG-F] or thymoglobulin), all other therapies, approved or investigational, for GvHD prophylaxis are excluded.
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (<=) 2 for participants aged ≥ 18 years at randomization or ≥ 60 percent (%) using the Karnofsky performance status for adolescent subjects aged ≥ 16 years at randomization or the Lansky performance status for adolescent participants aged 12 to ≤ 16 years at randomization.


Exclusion Criteria:

  • Had prior allo- HSCT.
  • Planned umbilical cord blood transplant or planned to receive posttransplant cyclophosphamide, in-vivo or ex-vivo T cell-depleted hematopoietic stem cells (HSCs) with the exception of ATG (ATG-F or thymoglobulin).
  • Planned allo-HSCT for nonmalignant hematological disorders (example; aplastic anemia, sickle cell anemia, thalassemias, Fanconi anemia or immunodeficiency).
Biologic/Vaccine, Drug, Other, Administration of prophylactic treatment, Allogeneic bone marrow transplantation, Allogeneic peripheral blood stem cell transplant, Drug therapy
Cancer, Graft versus host disease, Myeloproliferative disorders, Transplant disorder
Acute graft-versus-host reaction following bone marrow transplant, Allogeneic stem cell transplant, Bone marrow transplant, Malignant tumor of lymphoid hemopoietic and related tissue, Medical Oncology, Myeloproliferative disorder, Vedolizumab [USAN:INN], vedolizumab
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