bioihbjkbjnl/mcl2 huggingface dataset:
Ramelteon in the Prevention of Post-operative Delirium
Condition: Delirium; Delirium, Dementia, Amnestic, Cognitive Disorders; Delayed Emergence From Anesthesia; Cognitive Disorders
MeSH terms: Delirium; Emergence Delirium; Delayed Emergence from Anesthesia; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders
Intervention: Ramelteon; Microcrystalline Cellulose; Riboflavin 100 mg
Intervention description: 1 pre-operative and 2 nightly postoperative doses of Ramelteon/placebo will be administered; Placebo Comparator; Riboflavin will be added to both placebo and active intervention capsules in order to track adherence to dose while taken as an outpatient (i.e. only the first preoperative dose)
Intervention MeSH terms: Riboflavin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Post-operative Delirium

Summary:

      This trial focuses on a Phase II randomized masked clinical trial testing the effectiveness
      and safety of peri-operative administration of ramelteon, a melatonin agonist in the
      prevention of postoperative delirium.
    

Eligibility criteria:

        -  Planned orthopedic surgery under general or regional anesthesia and post-operative
             inpatient stay

          -  65 years of age or older

          -  Mini-mental Status Exam (MMSE) score of 15 or greater prior to surgery;

          -  Ability to understand, speak, read and write English.

        Exclusion Criteria:

          -  Delirium diagnosis on the Confusion Assessment Method instrument at baseline

          -  Is unable to give informed consent due to cognitive impairment and a suitable legally
             authorized representative (LAR) cannot be identified

          -  Declines participation

          -  Current medications that include:

               1. ramelteon

               2. melatonin

               3. fluvoxamine

               4. rifampin

               5. ketoconazole

               6. fluconazole

          -  History of ramelteon or riboflavin intolerance

          -  Heavy daily alcohol intake by medical record or history

          -  Current moderate to severe liver failure (as defined by Charlson criteria

          -  Evidence of Systemic Inflammatory Response Syndrome (SIRS) as measured by > 2
             criteria8)

          -  Presence of a condition that in the opinion of the PI compromises patient safety or
             data quality if enrolled in the study.
Trial of Sunitinib for Refractory Malignant Ascites
Condition: Ascites
MeSH terms: Ascites
Intervention: Sunitinib
Intervention description: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total).
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: malignant ascites

Summary:

      The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in
      patients with refractory malignant ascites.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Solid tumor malignancy and failure of at least one biologic or cytotoxic regimen, or
             the inability to receive standard treatment due to performance status (PS>2).

          -  Ascites based on paracentesis or CT scan within one month prior to enrollment

          -  Life expectancy > 3 months

          -  Indwelling paracentesis catheters are permitted, paracentesis is permitted at the
             investigators discretion

          -  Negative urine pregnancy test for females

          -  All subjects must agree to use birth control

          -  All subjects must abstain from eating grapefruit and grapefruit juice. They must tell
             their physicians about any changes in their medication including over-the-counter and
             herbal supplements.

        Exclusion Criteria:

          -  History of congestive heart failure

          -  Creatinine > 2.0

          -  Pregnant or nursing

          -  ALT > 2.5 times the upper limit of normal

          -  Blood pressure > 160/90 (antihypertensives permitted)

          -  Gastrointestinal or intra-abdominal hemorrhage within the last 6 months

          -  History of QTc > 450 milliseconds

          -  Brain metastasis
Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 (COVID-19) Infection
Condition: Sars-CoV-2 Infection
MeSH terms: Infections; Communicable Diseases; COVID-19
Intervention: Peginterferon lambda alfa-1a subcutaneous injection; Saline
Intervention description: Peginterferon lambda-1a 180 micrograms by subcutaneous injection; Saline subcutaneous injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, single-blind, controlled trial
Masking: Single (Participant)
Masking description: Single-blinded study
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: SARS-CoV-2; COVID-19; Lambda interferon

Summary:

      This is a phase 2b prospective, randomized, single-blind, controlled trial of a single
      subcutaneous injection of peginterferon lambda-1a versus placebo for prevention of SARS-CoV-2
      infection in non-hospitalized participants at high risk for infection due to household
      exposure to an individual with coronavirus disease (COVID-19). The study will also evaluate
      the regimens participants with asymptomatic SARS-CoV-2 infection detected at study entry. All
      participants will be followed for up to 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  Peripheral capillary oxygen saturation (SpO2) ≥ 95% on room air at screening

          -  Age ≥18 years

        Exclusion Criteria:

          -  Hospitalized or impending hospitalization at the time of screening

          -  Symptoms of cough, fever or shortness of breath within 72 hours

          -  Prior or current treatment with other experimental or approved agents targeting
             SARS-CoV-2 or SARS-CoV-1

          -  Positive pregnancy test

          -  Active autoimmune disease or sarcoidosis (with the exception of controlled thyroid
             disease)

          -  Active decompensated liver disease (ascites, encephalopathy)

          -  Active congestive heart failure
Sirolimus Versus Anti-Vascular Endothelial Growth Factor (antiVEGF) for Wet AMD
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Sirolimus; Standard of Care intravitreal injections of anti-VEGF
Intervention description: intravitreal injection; intravitreal injections of anti-VEGF
Intervention MeSH terms: Sirolimus; Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase 2 clinical trial, single site, randomized, subject-masked study to determine safety and
      efficacy of intravitreal injections of Sirolimus in subjects with wet Age-Related Macular
      Degeneration (wet AMD) with persistent intraretinal or subretinal edema due to neovascular
      AMD despite previous AntiVEGF treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  best corrected visual acuity of 5-65, inclusive, in study eye

          -  presence of choroid neovascularization secondary to AMD

          -  persistent edema despite at least 3 previous intravitreal anti-VEGF injections in the
             past 5 months

        Exclusion Criteria:

          -  greater than 100 micron decrease in central subfield thickness on Optical Coherence
             Topography (OCT) since last standard of care visit

          -  history of major ophthalmic surgery in the study eye in the past 3 months

          -  history of significant ocular disease or condition other than exudative AMD that may
             confound results
Copper Concentration & Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840
Condition: Wilson Disease
MeSH terms: Hepatolenticular Degeneration
Intervention: Bis-Choline Tetrathiomolybdate
Intervention description: Participants will be initiated at 15 milligrams once daily, then the dose will be increased to 30 milligrams once daily at Week 6.
Intervention MeSH terms: Tetrathiomolybdate; Choline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: This study is only pathologist-blinded for the assessments of liver histology samples.
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Copper; ALXN1840; Histology; Liver Biopsy

Summary:

      The main objective of the study is to evaluate the change in liver copper (Cu) concentration
      following 48 weeks of treatment with ALXN1840 in adult participants with Wilson Disease (WD)
      who have been previously treated for at least 1 year with standard of care (that is,
      trientine, penicillamine, or zinc). In the Treatment Period, efficacy and safety of ALXN1840
      will be assessed at Week 48.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of WD by Leipzig Criteria ≥ 4 or by historical test results.

          2. Continuous treatment for WD with penicillamine, trientine or zinc for at least 1 year
             prior to screening.

          3. Body mass index < 30 kilograms/meter squared.

          4. Able to cooperate with a percutaneous liver biopsy.

          5. Willing and able to follow protocol-specified contraception requirements.

          6. Capable of giving signed informed consent.

        Exclusion Criteria:

          1. Decompensated cirrhosis or Model for End Stage Liver Disease score > 13.

          2. Modified Nazer score > 7.

          3. Clinically significant gastrointestinal bleed within past 3 months.

          4. Alanine aminotransferase > 2 × upper limit of normal.

          5. History of bleeding abnormality or known coagulopathy, including platelet count <
             100,000, and international normalized ratio for prothrombin time ≥ 1.5.

          6. Participant unwilling to accept blood products, if required.

          7. Marked neurological disease requiring either nasogastric feeding tube or intensive
             inpatient medical care.

          8. Hemoglobin less than lower limit of the reference range for age and sex.

          9. Participants in renal failure, defined as in end-stage renal disease on dialysis
             (chronic kidney disease 5) or creatinine clearance < 30 milliliters/minute.

         10. Lymphoma, leukemia, or any malignancy within the past 5 years.

         11. Current or chronic history of liver disease not associated with WD.
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Condition: Irritable Bowel Syndrome With Constipation
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Linaclotide; Matching Placebo
Intervention description: Oral, once daily; Oral, once daily
Intervention MeSH terms: Linaclotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 759.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to evaluate the safety, efficacy, and dose response of two
      delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is
      DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C).
      Additional objectives include understanding how the two DR formulations compare with each
      other and with the FDA-approved 290 μg LINZESS® (the immediate release [IR] formulation of
      linaclotide).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has completed a colonoscopy according to the American Gastroenterological
             Association (AGA) criteria, with no clinically significant findings

          -  Patient has no clinically significant findings on a physical examination and clinical
             laboratory tests

          -  Patient meets protocol criteria for diagnosis of IBS-C

          -  Patient demonstrates continued IBS-C through Pretreatment Period

          -  Patient maintains a minimum level of compliance with daily diary

        Exclusion Criteria:

          -  Patient has history of loose or watery stools

          -  Patient has symptoms of or been diagnosed with a medical condition that may contribute
             to abdominal pain

          -  Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease
             or condition that can affect GI motility

          -  Patient has any protocol-excluded or clinically significant medical or surgical
             history that could confound the study assessments
Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
Condition: Dermatomyositis
MeSH terms: Dermatomyositis
Intervention: JBT-101; Placebo
Intervention description: Part A: 20 mg once daily on Days 1-28, then 20 mg twice daily on Days 29-84.
Part B: JBT-101 20 mg twice daily on Days 1 - 365 of the OLE.; Part A: Once daily on Days 1-28, then twice daily on Days 29-84.
Part B: Placebo twice daily on Days 1 - 365 of the OLE.
Intervention MeSH terms: Lenabasum
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: JBT-101, lenabasum, dermatomyositis

Summary:

      The purpose of this study is to evaluate the safety, tolerability and efficacy of JBT-101 in
      adult subjects with skin-predominant, dermatomyositis (DM) that is refractory to at least 3
      months treatment with hydroxychloroquine.
    

Eligibility criteria:

        Inclusion Criteria (Part A):

          -  CDASI activity score ≥ 14;

          -  No difficulty with lifting or walking, and no more than 1.5 x the upper limit of
             normal of creatine phosphokinase or aldolase;

          -  Failed at least 3 months treatment with hydroxychloroquine;

          -  Stable treatment for dermatomyositis for at least 28 days before Visit 1 (Day 1).

        Inclusion Criteria (Part B):

          -  Completion of dosing in Part A without permanent discontinuation of study product
             because of safety or tolerability reasons

        Exclusion Criteria (Part A and B):

          -  Significant diseases or conditions other than DM that may influence response to the
             study product or safety;

          -  Any one of the following values for laboratory tests at Screening:

               1. A positive pregnancy test (or at Visit 1);

               2. Hemoglobin < 10 g/dL;

               3. Neutrophils < 1.0 x 10^9/L;

               4. Platelets < 75 x 10^9/L;

               5. Creatinine clearance < 50 ml/min according to modified Cockcroft-Gault equation;

               6. Aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase >
                  2.5 x upper normal limit;

               7. Total bilirubin ≥ 1.5 x upper limit of normal.

          -  Any other condition that, in the opinion of the Principal Investigator, is clinically
             significant and may put the subject at greater safety risk, influence response to
             study product, or interfere with study assessments.
Evaluation of Exercise Treadmill Test (ETT) Indices in Participants With Cardiovascular Disease
Condition: Atherosclerotic Coronary Vascular Disease
MeSH terms: Cardiovascular Diseases; Vascular Diseases
Intervention: Ranolazine 500 mg
Intervention description: Ranolazine 500 mg, oral tablet, b.i.d.
Intervention MeSH terms: Ranolazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Cardiovascular disease; Exercise Treadmill Test; Ranolazine; Angina; Myocardial ischemia

Summary:

      The study was designed to evaluate the use of ETT electrocardiogram (ECG) indices as
      biomarkers in the assessment of atherosclerotic coronary vascular disease (ASCVD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of stable coronary artery disease

        Exclusion Criteria:

          -  Inability or unwillingness to participate in multiple exercise treadmill tests and/or
             any other requirements of this study as assessed by the Investigator.

               -  History of chronic atrial fibrillation.

        Other protocol-defined inclusion/exclusion criteria may apply.
RTA 408 Ophthalmic Suspension for the Treatment of Ocular Inflammation and Pain Following Ocular Surgery
Condition: Inflammation and Pain Following Ocular Surgery
MeSH terms: Inflammation
Intervention: Omaveloxolone Ophthalmic Suspension 1.0%; Omaveloxolone Opthalmic Suspension 0.5%; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RTA 408; Ocular surgery; Cataract surgery; Ocular inflammation; Ocular pain; Eye inflammation; omaveloxolone

Summary:

      This study assesses the efficacy and safety of two concentrations of RTA 408 Ophthalmic
      Suspension in the treatment of patients who have inflammation and pain following ocular
      surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be greater than or equal to 18 years of age of either sex or any race;

          2. Have undergone unilateral cataract extraction via phacoemulsification on the day prior
             to study enrollment/randomization;

          3. Have a grade of ≥2 in anterior chamber cell score on day after surgery (Day 1);

          4. Have a potential post-operative pin-hole visual acuity (VA) of greater than 1.0
             logarithm of the minimum angle of resolution (logMAR) in the operative eye and fellow
             eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart;

        Exclusion Criteria:

          1. Have any intraocular inflammation present in the study eye during the screening slit
             lamp examination;

          2. Have a score greater than "0" on the Ocular Pain Assessment at Screening in the study
             eye;

          3. Have an immunosuppressive disease or an autoimmune disease that in the opinion of the
             Investigator could affect the quality of the ocular surface;

          4. Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and
             will likely affect wound healing;

          5. Have an intraocular pressure (IOP) ≤ 5 mmHg in either eye;

          6. Require the use of a contact lens or a collagen shield within 72 hours of
             investigational drug treatment or during the study period in the study eye; be
             unwilling to discontinue use of contact lenses during study period in the study eye;

          7. Require use of non-diagnostic topical ophthalmic solutions (other than perioperative
             mydriatics, anesthetics and antiseptics, prophylactic antibiotics, lid scrubs for mild
             blepharitis, or artificial tears for the management of dry eye) in the study eye for
             the duration of the study;
Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
Condition: Liver Cirrhosis, Biliary
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Fibrosis
Intervention: INT-747; Ursodeoxycholic Acid (URSO); Placebo
Intervention description: Once a day (QD) by mouth (PO); Stable dose for at least 6 months prior to screening. Dose as prescribed by physician.; Placebo
Intervention MeSH terms: Ursodeoxycholic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: PBC, Primary Biliary Cirrhosis, Liver,

Summary:

      The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels
      in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female age 18 to 70 years.

          -  Stable dose of ursodeoxycholic acid (URSO, UDCA) for at least 6 months prior to
             screening.

          -  Female patients must be postmenopausal, surgically sterile, or prepared to use 2
             methods of contraception with all sexual partners during the study and for 14 days
             after the end of dosing.

          -  Male patients must be prepared to use 2 methods of contraception with all sexual
             partners during the study and for 14 days after the end of the dosing.

          -  Proven or likely PBC, as demonstrated by the patient presenting with at least 2 of the
             following 3 diagnostic factors:

               1. History of increased AP levels for at least 6 months prior to Day 0

               2. Positive AMA titer (>1:40 titer on immunofluorescence or M2 positive by ELISA) or
                  PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive)

               3. Liver biopsy consistent with PBC.

          -  Screening AP value between 1.5 and 10 × ULN.

        Exclusion Criteria:

          -  Administration of the following drugs at any time during the 3 months prior to
             screening for the study: colchicine, methotrexate, azathioprine, or systemic
             corticosteroids.

          -  Screening conjugated (direct) bilirubin >2 × ULN.

          -  Screening ALT or AST >5 × ULN.

          -  Screening serum creatinine >1.5 mg/dL (133 mol/L).

          -  History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy,
             or poorly controlled ascites).

          -  History or presence of other concomitant liver diseases including hepatitis due to
             hepatitis B or C virus (HCV, HBV) infection, primary sclerosing cholangitis (PSC),
             alcoholic liver disease, definite autoimmune liver disease or biopsy proven
             nonalcoholic steatohepatitis (NASH).

          -  Pregnancy.