bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: RIST4721; Placebo
Intervention description: RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets; Matching placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and
      Safety of RIST4721 in Subjects with Hidradenitis Suppurativa
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of HS for at least 1 year prior to screening

          -  HS lesions must be present in at least 2 distinct anatomic areas

          -  A total AN count (sum of abscesses and inflammatory nodules) > 6 across all anatomical
             sites at both the screening and baseline visits

          -  Willing to use contraception for the duration of the study

        Exclusion Criteria:

          -  Presence of other skin conditions which may interfere with study assessments

          -  Presence of active, chronic or latent bacterial, viral, fungal mycobacterial infection
             (including latent TB) or history of infection within 4 weeks of screening

          -  Body Mass Index (BMI) >48kg/m2

          -  Breastfeeding or pregnant
Safety, Tolerability and Efficacy of Sofosbuvir, Velpatasvir, and Voxilaprevir in Subjects With Previous DAA Experience
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Sofosbuvir/Velpatasvir/Voxilaprevir
Intervention MeSH terms: Sofosbuvir; Velpatasvir; Sofosbuvir-velpatasvir drug combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C relapse

Summary:

      This study will evaluate the safety, tolerability, and efficacy of
      sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C
      infection who have failed to eradicate hepatitis C despite previous combination directly
      acting antiviral therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Available for clinical follow-up through Week 44 after enrollment.

          -  Recurrent HCV GT-1

          -  Exposure to combination DAA therapy

          -  Able and willing to complete the informed consent process.

          -  Use of protocol specified methods of contraception

          -  Hepatitis B coinfected participants must have evidence of chronic infection and
             controlled on treatment

          -  HIV coinfected participants must have HIV status of one of the following:

               1. HIV untreated for >8 weeks prior to screening, CD4 >500, no intention of
                  initiating ARV therapy for the duration of the trial.

               2. HIV suppressed on a stable, protocol-approved ARV regimen for >4 weeks prior to
                  screening.

        Exclusion Criteria:

          -  Combination DAA therapy was completed or discontinued less than 8 weeks prior to
             enrollment.

          -  Current or prior history of any clinically significant illness, organ transplantation,
             and/or concomitant medication that may interfere with the subject treatment,
             assessment of compliance with the protocol.

          -  Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease,
             alfa-1 antitrypsin deficiency, cholangitis)

          -  Laboratory results outside acceptable ranges at screening.

          -  Female who is pregnant, breast-feeding or planning to become pregnant during study.
Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: Fluorine18 (18F) Fluoromisonidazole (FMISO) Imaging
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: FMISO; FMISO; FMISO
Intervention description: FMISO PET/CT imaging at baseline; FMISO PET/CT post TACE; FMISO PET/CT post SBRT
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      [18F] FMISO Positron Emission Tomography (PET) to determine hypoxia in patients with HCC
      treated with TACE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (> 18 years of age) patients with documented HCC tumor mass >3cm, who are
             scheduled to undergo TACE with additional selective internal radiation therapy (SIRT)

          -  The appropriate criteria for inclusion for this patient population are:

          -  Biopsy or radiological diagnosis of HCC (defined as Organ Procurement and
             Transplantation Network (OPTN*) Category 5 lesion either on CT or MRI)

          -  Scheduled for TACE (using doxorubicin-eluting beads) + SBRT

          -  Willingness to undergo PET/CT

          -  Able to lie on the imaging table for up to 1 hour.

          -  Able to provide signed informed consent.

          -  Women with childbearing potential must have a negative urine Beta-Human Chorionic
             Gonadotropin (β-hCG) test day of procedure

        Exclusion Criteria:

          -  Estimated life expectancy <12 months or serious medical co-morbidities that would
             preclude definitive local therapy

          -  Unable to lie on the imaging table

          -  Age less than 18 years.

          -  Pregnancy or lactation

          -  Inability or unwillingness to provide informed consent.

          -  Weight >500 lbs (the weight limit of the tomograph gantry table)
A Phase 2 Study of Elobixibat in Adults With NAFLD or NASH
Condition: NAFLD; NASH
MeSH terms: Non-alcoholic Fatty Liver Disease
Intervention: Elobixibat; Placebo oral tablet
Intervention description: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).; Placebo identical in appearance to active drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-Blind, Randomized, Placebo-Controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Double-blind, randomized, placebo-controlled study to explore the efficacy and safety of
      elobixibat compared to placebo in adults with NAFLD (nonalcoholic fatty liver disease) or
      NASH (nonalcoholic steatohepatitis)
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Have a current biopsy-confirmed NASH within 6 months of screening or a suspected
             diagnosis of NAFLD/NASH

          -  Screening magnetic resonance imaging-proton density fat fraction (MRI-PDFF) with ≥10%
             liver steatosis

          -  Fasting serum low density lipoprotein-cholesterol (LDL-C) >130 mg/dL at Screening,
             >110 mg/dL on lipid-lowering medications

        Key Exclusion Criteria:

          -  Body mass index (BMI) <25 kg/m2

          -  Fibrosis-4 index (Fib-4) >2.6

          -  Any of the following laboratory abnormalities:

               1. alanine aminotransferase (ALT) >5 × upper limit of normal (ULN) or aspartate
                  aminotransferase (AST) >5 × ULN

               2. International normalized ratio (INR) ≥1.3, unless on anticoagulant therapy

               3. Total bilirubin >ULN, except with an established diagnosis of Gilbert's syndrome

               4. Platelet count less than the lower limit of normal (LLN)

               5. Creatinine clearance as calculated by the modification of diet in renal disease
                  (MDRD) estimated glomerular filtration rate (eGFR) equation <60 mL/min

          -  Uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) >9.5%

          -  Clinical hyperthyroidism or hypothyroidism or screening hormone results pointing to
             thyroid dysfunction.

          -  Uncontrolled hypertension

          -  Participants with known intolerance to MRI or with conditions contraindicated for MRI
             procedures
Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Intervention: riluzole
Intervention description: 100 mg orally twice daily
Intervention MeSH terms: Riluzole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage III melanoma; stage IV melanoma; recurrent melanoma

Summary:

      RATIONALE: Riluzole may stop or slow the growth of tumor cells and may be an effective
      treatment for melanoma.

      PURPOSE: This phase II trial is studying how well riluzole works in treating patients with
      stage III or stage IV melanoma that cannot be removed by surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed malignant melanoma

               -  Unresectable stage III or stage IV disease

          -  Measurable disease according to RECIST criteria, defined as ≥ 1 unidimensionally
             measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan

          -  No known brain metastases unless treated and stable for ≥ 2 weeks by MRI evaluation

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  ANC ≥ 1,000/μL

          -  Platelet count ≥ 50,000/μL

          -  Total bilirubin ≤ 2 times upper limit of normal (ULN)

          -  AST/ALT ≤ 3 times ULN

          -  INR ≤ 1.5 times ULN

          -  Not pregnant

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 2 weeks after
             completion of study treatment

          -  No second primary malignancy, except carcinoma in situ of the cervix, adequately
             treated nonmelanoma carcinoma of the skin, or other malignancy treated ≥ 5 years ago
             with no evidence of recurrence

          -  No concurrent serious systemic disorders (including active infections) that, in the
             opinion of the investigator, would compromise the safety of the patient or compromise
             the patient's ability to complete the study

          -  No history of allergic reactions attributed to riluzole

          -  No known history of hepatitis B or C

        PRIOR CONCURRENT THERAPY:

          -  No more than 1 prior therapeutic chemotherapy regimen for advanced melanoma

          -  Prior treatment with riluzole on clinical trial CINJ-090603 allowed

          -  No other concurrent investigational or commercial agents or therapies for the
             treatment of the malignancy
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: SOF/VEL; RBV
Intervention description: 400/100 mg FDC tablet administered orally once daily; RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and SOF/VEL FDC and
      ribavirin (RBV) for 12 weeks in participants with chronic genotype 3 hepatitis C virus (HCV)
      infection and compensated cirrhosis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  Individuals with chronic genotype 3 HCV infection and compensated cirrhosis

          -  Individuals with or without HIV-1 coinfection

        Key Exclusion Criteria:

          -  History of clinically significant illness or any other medical disorder that may
             interfere with individual's treatment assessment or compliance with the protocol

          -  Co-infection with active hepatitis B virus

          -  Laboratory results outside the acceptable ranges at screening

          -  Pregnant or nursing female

          -  Chronic liver disease not caused by HCV

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Tezacaftor/Ivacaftor; Ivacaftor; Tezacaftor/Ivacaftor matching placebo; Ivacaftor matching placebo
Intervention description: Tezacaftor/Ivacaftor FDC
Intervention MeSH terms: Ivacaftor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the clinical mechanisms of action in lung and extrapulmonary systems of VX-661
      (tezacaftor; TEZ) in combination with ivacaftor (IVA) (TEZ/IVA) in participants with cystic
      fibrosis (CF) who are homozygous for the F508del mutation on the CF transmembrane conductance
      regulator (CFTR) gene.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants, homozygous for the F508del CFTR mutation

          -  Confirmed diagnosis of CF by sweat chloride testing

          -  Forced Expiratory Volume in 1 Second (FEV1) ≥40% and ≤90% of predicted normal for age,
             sex, and height at Screening Visit

          -  Stable CF disease as judged by the investigator.

        Exclusion Criteria:

          -  History of any comorbidity that, in the opinion of the investigator, might confound
             the results of the study or pose an additional risk in administering study drug to the
             subject.

          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
             therapy for pulmonary disease within 28 days before Day 1

          -  History or evidence of clinically significant findings on ophthalmologic examination
             during the Screening Period.

          -  History of solid organ or hematological transplantation

          -  Pregnant or nursing females

          -  Participants who have had radiation exposure within 1 year before the first
             mucociliary clearance (MCC) procedure that would cause them to exceed federal
             regulations by participating in this study

          -  In the opinion of the investigator, unable to adequately perform inhalation maneuvers
             during the MCC procedures
Adjunctive Ganaxolone Treatment (Part A) in TSC Followed by Long-term Treatment (Part B)
Condition: Tuberous Sclerosis
MeSH terms: Tuberous Sclerosis; Sclerosis
Intervention: Ganaxolone
Intervention description: titration followed by maintenance and extension period
Intervention MeSH terms: Ganaxolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 2 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To assess preliminary safety and efficacy of ganaxolone as adjunctive therapy for the
      treatment of primary seizure types in patients with genetically- or clinically-confirmed
      TSC-related epilepsy through the end of the 12 week treatment period.
    

Eligibility criteria:

        Inclusion Criteria (Part A):

          -  Clinical or mutational diagnosis of TSC

          -  Failure to control seizures despite appropriate trial of 2 or more ASMs at therapeutic
             doses.

          -  Have at least 8 countable/witnessed primary seizures during the 4-week baseline period
             with at least 1 primary seizure occurring in at least 3 of the 4 weeks of baseline.

        Inclusion Criteria (Part B)

        • Patients have experienced ≥ 35% reduction in primary seizure frequency during the Part A
        treatment period compared to the 4-week Baseline Period.

        Exclusion Criteria (Part A):

          -  Previous exposure to GNX

          -  Pregnant or breastfeeding

          -  Concurrent use of strong inducers or inhibitors of cytochrome P450 (CYP)3A4/5/7. Any
             strong inhibitor or inducer of CYP3A4/5/7 must be discontinued at least 28 days before
             Visit 2, study drug initiation. This does not include approved ASMs.

          -  Patients who have been taking felbamate for less than 1 year prior to screening

          -  Patients who test positive for tetrahydrocannabinol (THC) or non-approved cannabidiol
             (CBD) via plasma drug screen

          -  Chronic use of oral steroid medications, ketoconazole (except for topical
             formulations), St. John's Wort, or other IPs is not permitted

          -  Have an active CNS infection, demyelinating disease, degenerative neurological
             disease, or CNS disease deemed progressive. This includes tumor growth which in the
             opinion of the investigator could affect primary seizure control

          -  Patients with significant renal insufficiency, estimated glomerular filtration rate
             (eGFR) < 30 mL/min (calculated using the Cockcroft-Gault formula or Pediatric GFR
             calculator or Bedside Schwartz), will be excluded from study entry or will be
             discontinued if the criterion is met post baseline

          -  Have been exposed to any other investigational drug within 30 days or fewer than 5
             half lives (whichever is shorter) prior to the screening visit
Study of SAF312 as an Eye Drop for Treatment of Eye Pain Following Photorefractive Keratectomy (PRK) Surgery
Condition: Postoperative Ocular Pain After PRK Surgery
MeSH terms: Eye Pain
Intervention: SAF312; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ocular pain; photorefractive keratectomy (PRK); SAF312; corneal epithelial defect

Summary:

      The purpose of this study is to determine if SAF312 eye drops have an adequate safety and
      efficacy profile to justify further clinical development for the treatment of ocular pain
      associated with corneal epithelial defect such as after photorefractive keratectomy (PRK)
      surgery
    

Eligibility criteria:

        Inclusion Criteria:

          -  Normal eye exam except for refractive error at baseline.

          -  Myopia should not exceed -4.00 Diopters (sphere) and 3.00 diopters of astigmatism,
             with spherical equivalent not higher than -4.50, confirmed by manifest refraction at
             baseline.

        Exclusion Criteria:

          -  Monocular patient (including amblyopia) or best corrected visual acuity score worse
             than 20/80 (Snellen) or 55 letters (EDTRS), at baseline.

          -  Any systemic or ocular disease that might affect wound healing (such as severe
             rheumatoid arthritis or diabetes or history of keloid formation) or a history of
             ocular trauma, uveitis, infection, or inflammation in the 6 months prior to baseline.

          -  Previous refractive or corneal surgery (such as LASIK, PRK, radial keratotomy,
             pterygium removal, corneal transplantation).

          -  Chronic pain of any etiology or any significant illness which has not resolved within
             two (2) weeks prior to initial dosing.

        Other inclusion and exclusion criteria apply.
Carbidopa for the Treatment of Excessive Blood Pressure Variability
Condition: Dysautonomia, Familial; Baroreflex Failure Syndrome
MeSH terms: Primary Dysautonomias; Autonomic Nervous System Diseases; Dysautonomia, Familial
Intervention: Carbidopa Low-Dose; Placebo; Carbidopa High-Dose
Intervention description: 300 mg/day; A placebo containing an inert substance, in capsule form that does not contain an active drug ingredient.; 600 mg/day
Intervention MeSH terms: Carbidopa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 10 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Familial dysautonomia (HSAN III); Norepinephrine; Sympathetic nervous system; Autonomic nervous system; Blood pressure variability; Hypertension; Carbidopa/Lodosyn; Afferent baroreflex failure; Clinical trial

Summary:

      The overall study objectives are to determine whether carbidopa (Lodosyn®) is safe and well
      tolerated and to assess whether it can inhibit catecholamine-induced paroxysmal hypertension
      and normalize or reduce the exaggerated blood pressure variability in patients with familial
      dysautonomia (FD, also called hereditary sensory and autonomic neuropathy type III or
      Riley-Day syndrome). Funding Source- FDA OOPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients with familial dysautonomia (FD) age 10 or older

          -  Unstable blood pressure, defined as:

               -  Systolic BP standard deviation >15 mmHg

               -  Or coefficient of variation >15%

               -  Or documented episodic hypertensive peaks (>140mmHg)

          -  Confirmed diagnosis of FD (genetic testing)

          -  Providing written informed consent (or ascent) to participate in the trial

          -  Ability to comply with the requirements of the study procedures.

        Exclusion Criteria:

          -  Patients taking monoamine oxidase (MAO)-inhibitors

          -  Patients taking: metoclopramide, domperidone, risperidone or other dopamine blockers

          -  Patients taking tricyclic antidepressants

          -  Patients taking neuroleptic drugs (haloperidol and chlorpromazine)

          -  Patients with a known hypersensitivity to any component of this drug.

          -  Patients with atrial fibrillation, angina or significant ECG abnormality

          -  Patients with significant pulmonary, cardiac, liver, renal (creatinine >2.0 mg/ml)

          -  Patients who have a significant abnormality on clinical examination that may, in the
             investigator's opinion might jeopardize their healthy participating in this trial.

          -  Women who are pregnant or lactating.