bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: SEL; Placebo to match SEL 6 mg; Placebo to match SEL 18 mg
Intervention description: Tablets administered orally once daily; Tablets administered orally once daily; Tablets administered orally once daily
Intervention MeSH terms: Selonsertib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 883.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can
      cause fibrosis regression and reduce associated complications in adults with cirrhosis due to
      NASH.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Liver biopsy consistent with NASH and cirrhosis (F4 fibrosis) according to the NASH
             Clinical Research Network (CRN) classification, in the opinion of the central reader

          -  Has the following laboratory parameters at the screening visit, as determined by the
             central laboratory:

               -  Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)

               -  Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the
                  Cockcroft-Gault equation

               -  HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 micromole (μmol) if HbA1c is unable to
                  be resulted)

               -  International normalised ratio (INR) ≤ 1.4, unless due to therapeutic
                  anti-coagulation

               -  Platelet count ≥ 100,000/μL

        Key Exclusion Criteria:

          -  Prior history of decompensated liver disease including clinical ascites, hepatic
             encephalopathy (HE), or variceal bleeding

          -  Child-Pugh (CP) score > 7, as determined at screening, unless due to therapeutic
             anti-coagulation

          -  Model for End-stage Liver Disease (MELD) score > 12, as determined at screening,
             unless due to therapeutic anti-coagulation

          -  Other causes of liver disease including, but not limited to, alcoholic liver disease,
             hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson
             disease, iron overload, and alpha-1-antitrypsin deficiency, based on medical history
             and/or centralized review of liver histology.

          -  History of liver transplantation

          -  Current or history of hepatocellular carcinoma (HCC)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Immunogenicity and Safety of Quadrivalent Influenza Vaccine (NBP607-QIV) in Adults and Elderly Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: NBP607-QIV; NBP607-Y; NBP607-V
Intervention description: Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria; Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata; Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1503.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza vaccine; Quadrivalent; Inactivated cell culture-derived

Summary:

      All participants received a single dose of their assigned vaccine on Day 0. They were
      followed up for immunogenicity and safety through Day 21 post-vaccination. Serious adverse
      events were collected for 6 months post-vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults aged 19 years and older

          -  Those who are able to comply with the requirements for the study

          -  If women, a negative pregnancy test and willingness to use birth control measures for
             the entire study duration

        Exclusion Criteria:

          -  Disorders in immune function

          -  Any malignancy or lymphoproliferative disorder

          -  History of Guillain-Barré syndrome

          -  Individuals with a known bleeding diathesis, or any condition that may be associated
             with a prolonged bleeding time

          -  Experience of fever (>38.0 ℃) within 24 hours following vaccination

          -  Body temperature >38.0 ℃ at the vaccination day

          -  Concomitant medications/therapy such as immunosuppressants or immune modifying drugs,
             systemic corticosteroids, immunoglobulins, blood or blood- derived products within 3
             months

          -  Influenza vaccination within 6 months

          -  Subjects who have participated in other interventional study within 4 weeks

          -  Any vaccination within 1 month

          -  Those who are planning to receive any vaccine within 1 month from the study vaccine

          -  Individuals with any serious chronic or progressive disease

          -  Pregnant or breast-feeding women

          -  Any other reason that in the opinion of the investigator might interfere with the
             study
A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia; Psychomotor Agitation
Intervention: Brexpiprazole; Brexpiprazole
Intervention description: 2 or 3 mg tablet; 0.5 to 3 mg tablet
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 259.0
Sex: All
Minimum age: 55 Years
Maximum age: 91 Years
Healthy volunteers: No
Keywords: Agitation

Summary:

      Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and
      tolerability of oral brexpiprazole as treatment in adult participants with agitation
      associated with dementia of the Alzheimer's type (AAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have participated in the 331-14-213 study.

          -  Participants must have an identified caregiver who has contact, at a minimum of 2
             hours per day, 4 days per week to describe the participant's symptoms and can observe
             participant behavior.

        Exclusion Criteria:

          -  Participants with a substantial protocol violation during the course of their
             participation in the double-blind trial 331-14-213.
A Study to Evaluate SAGE-217 for Prevention of Relapse in Adult Participants With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: SAGE-217; Placebo
Intervention description: SAGE-217 capsule; SAGE-217 matching placebo capsule
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: MDD; SAGE-217

Summary:

      This is a study with an Open-Label (OL) phase followed by a randomized, Double-Blind (DB),
      placebo-controlled phase to assess efficacy and safety of SAGE-217 on relapse prevention in
      adults with major depressive disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant had a diagnosis of MDD as diagnosed by Structured Clinical Interview for
             Diagnostic and DSM-5 Clinical Trial Version (SCID-5-CT), with symptoms that had been
             present for at least a 4-week period.

          2. Participant had at least 1 prior major depressive episode (MDE) in the 5 years prior
             to Screening (not including the current episode).

          3. Participant was willing to delay the start of any antidepressant, anxiolytic,
             insomnia, psychostimulant, prescription opioid regimens, and new psychotherapy
             (including Cognitive Behavioral Therapy for Insomnia [CBT-I]) until after study
             completion.

        Exclusion Criteria:

          1. Participant had attempted suicide associated with the current episode of MDD.

          2. Participant had treatment-resistant depression, defined as persistent depressive
             symptoms despite treatment with adequate doses of antidepressants within the current
             major depressive episode (excluding antipsychotics) from two different classes for at
             least 4 weeks of treatment. Massachusetts General Hospital Antidepressant Treatment
             Response Questionnaire (MGH ATRQ) was used for this purpose.

          3. Participant had a positive pregnancy test at screening or on Day 1 prior to dosing.
A Study to Evaluate the Long-term Use of Valsartan in Children 6 Months to 5 Years Old With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Valsartan
Intervention description: Extemporaneous suspension of valsartan, orally.
Intervention MeSH terms: Valsartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 6 Months
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Children; pediatrics; High Blood Pressure; Hypertension; Valsartan

Summary:

      The purpose of this study is to evaluate the efficacy, safety and tolerability of long-term
      use (up to 18 weeks) of valsartan in children 6 months to 5 years old with hypertension.
    

Eligibility criteria:

        Inclusion criteria

          -  Participants who qualified and entered the core study.

          -  Participants who participated in the core study, completed Period 1 and were
             re-randomized in Period 2 and continued for at least 3 days in Period 2.

        Exclusion criteria

          -  Participants who did not complete Period 1 of the core study.

          -  Participants who were re-randomized in Period 2 of core study but did not continue for
             => 3 days in Period 2 of the core study.

          -  Participants who experienced any adverse events considered serious or drug related in
             the core study.

          -  Participants excluded from the core study.
An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: CB-03-01 cream, 1%
Intervention description: Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 609.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No
Keywords: acne; clascoterone; anti-androgen

Summary:

      The primary objective of this study is to determine the long-term safety of CB-03-01 cream,
      1% applied twice daily for an additional nine months in study participants with acne vulgaris
      that participated in the Phase 3 pivotal studies for a total treatment of up to 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has successfully completed participation in one of the Phase 3 pivotal
             studies [CB-03-01/25 and CB-03-01/26].

          -  Participant agrees to use effective method of contraception throughout study, if
             applicable.

          -  Participant has provided written informed consent or assent.

          -  Participant is willing to comply with study instructions and return to the clinic for
             required visits.

        Exclusion Criteria:

          -  Participant is pregnant, lactating, or is planning to become pregnant during the
             study.

          -  Participant has any skin disease or condition that could interfere with the safety
             evaluation of the test products or requires the use of interfering topical or systemic
             therapy.

          -  Participant has any condition which, in the investigator's opinion, would make it
             unsafe or unsuitable for the participant to participate in this research study.

          -  Participant plans to use any other investigational drug or device during participation
             in this study.

          -  Participant has known hypersensitivity or previous allergic reaction to the drug or
             any of its ingredients.

          -  Participant is or plans to use any restricted systemic and/or topical anti-acne
             preparations or medications during the study
Evaluating the Effects of Tasimelteon vs. Placebo on Jet Lag Type Insomnia
Condition: Jet Lag Type Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Jet Lag Syndrome
Intervention: Tasimelteon; Placebo
Intervention description: Oral capsule; Oral capsule
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 320.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of this study is to investigate tasimelteon vs. placebo on sleep in healthy
      individuals after a phase advance in jet lag type insomnia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability and acceptance to provide written consent, fluent in English;

          -  Healthy subjects with no medical, psychiatric or current sleep disorders;

          -  Men or women between 18-75 years;

          -  Body Mass Index of ≥ 18 and ≤ 30 kg/m2.

        Exclusion Criteria:

          -  Major surgery, trauma, illness or immobile for 3 or more days within the past month;

          -  Pregnancy or recent pregnancy (within 6 weeks);

          -  A positive test for drugs of abuse at the screening or evaluation visit.
Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®
Condition: Cancer and Chemotherapy Related Anemia
MeSH terms: Anemia
Intervention: Injectafer; Normal Saline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 244.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase III, multicenter, randomized, double-blinded, prospective study with two parallel
      treatment groups. Patients who present to the hematologist/oncologist and satisfy all
      inclusion and exclusion criteria will be eligible for participation in this 18-week study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects (male of female) ≥ 18 years of age able to give informed consent to the
             study.

          -  Subjects with non-myeloid malignancies

          -  Receiving chemotherapy as part of their cancer treatment with at least 4 weeks of
             treatment remaining.

          -  Screening visit central laboratory hemoglobin (Hgb) ≤11 g/dL, but ≥8 g/dL.

          -  Ferritin between 100 and 800 ng/mL and transferrin saturation (TSAT) =<35%

          -  Subjects must have Eastern Coopertative Oncology Group (ECOG) performance status of
             0-2.

          -  Life expectancy of at least 6 months.

          -  Demonstrate the ability to understand the requirements of the study, willingness to
             abide by study restrictions and to return for the required assessments.

        Exclusion Criteria:

          -  Previous participation in a ferric carboxymaltose clinical trial.

          -  Known hypersensitivity reaction to any component of ferric carboxymaltose.

          -  Subjects with overt bleeding

          -  Any anemia treatment within 4 weeks before inclusion (oral iron, IV iron, transfusion,
             or erythropoiesis-stimulating agents).

          -  Subjects on erythropoiesis-stimulating agents.

          -  Requiring dialysis for the treatment of chronic kidney disease.

          -  Any non-viral infection.

          -  Known positive hepatitis with evidence of active disease.

          -  Received an investigational drug within 30 days of screening.

          -  Alcohol or drug abuse within the past 6 months.

          -  Hemochromatosis or other iron storage disorders.

          -  Any other laboratory abnormality, medical condition or psychiatric disorders which in
             the opinion of the Investigator would put the subject's disease management at risk or
             may result in the subject being unable to comply with study requirements.

          -  Pregnant or actively trying to become pregnant (Female subjects who are of
             childbearing age must have a negative pregnancy test at screening and be practicing an
             acceptable method of birth control during the study).
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
Condition: Narcolepsy
MeSH terms: Narcolepsy; Sleepiness
Intervention: JZP-110; Placebo oral tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 239.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter,
      4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of
      excessive sleepiness in adult subjects with narcolepsy.
    

Eligibility criteria:

        Major Inclusion Criteria:

          1. Males and females between 18 and 75 years of age, inclusive

          2. Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria

          3. Body mass index from 18 to <45 kg/m2

          4. Consent to use a medically acceptable method of contraception

          5. Willing and able to provide written informed consent

        Major Exclusion Criteria:

          1. Female subjects who are pregnant, nursing, or lactating

          2. Moderate or severe sleep apnea on the baseline PSG.

          3. Any other clinically relevant medical, behavioral, or psychiatric disorder other than
             narcolepsy that is associated with excessive sleepiness

          4. History or presence of bipolar disorder, bipolar related disorders, schizophrenia,
             schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5
             criteria

          5. History or presence of any acutely unstable medical condition, behavioral or
             psychiatric disorder (including active suicidal ideation), or surgical history that
             could affect the safety of the subject or interfere with study efficacy, safety, PK
             assessments, or the ability of the subject to complete the trial per the judgment of
             the Investigator

          6. History of bariatric surgery within the past year or a history of any gastic bypass
             procedure

          7. Presence or history of significant cardiovascular disease

          8. Use of any over-the-counter (OTC) or prescription medications that could affect the
             evaluation of excessive sleepiness

          9. Use of any medications that could affect the evaluation of cataplexy

         10. Received an investigational drug in the past 30 days or five half-lives (whichever is
             longer)

         11. Previous exposure to or participation in a previous clinical trial of JZP-110
             (ADX-N05, R228060, YKP10A)

         12. History of phenylketonuria (PKU) or history of hypersensitivity to
             phenylalanine-derived products
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)
Condition: Hypercholesterolemia; Atherosclerosis; Statin Adverse Reaction
MeSH terms: Atherosclerosis; Hypercholesterolemia
Intervention: Bempedoic acid; Ezetimibe; Placebo
Intervention description: bempedoic acid 180 mg tablet; ezetimibe 10 mg tablet; matching placebo tablet
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 269.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hyperlididemia; LDL; cholesterol; statin intolerance

Summary:

      The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe
      therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fasting LDL-cholesterol greater than or equal to 100 mg/dL at screening

          -  Men and nonpregnant, nonlactating women

          -  Use of stable lipid-modifying therapy for at least 4 weeks prior to screening that
             includes ezetimibe 10mg daily

        Exclusion Criteria:

          -  Fasting blood triglycerides greater than or equal to 500 mg/dL

          -  Body Mass Index (BMI) greater than or equal to 50 kg/m2

          -  Recent history of clinically significant cardiovascular disease

          -  Use of statin therapy where doses are greater than those defined as "low-dose" within
             4 weeks prior to screening; where "low-dose" is defined as an average daily dose of
             rosuvastatin 5 mg, atorvastatin 10 mg, simvastatin 10 mg, lovastatin 20 mg,
             pravastatin 40 mg, fluvastatin 40 mg, or pitavastatin 2 mg.