bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors
Condition: Hemophilia A; Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: fitusiran; Bypassing agents
Intervention description: solution for injection; by subcutaneous (SC) injection; solution for injection; by intravenous (IV) injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Male
Minimum age: 12 Years
Healthy volunteers: No
Keywords: RNAi therapeutic; Hemophilia A; Hemophilia B; Hemophilia A, Severe; Hemophilia B, Severe; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Factor VIII; Factor IX; Inhibitor; Bypassing agents; Coagulants; Fitusiran

Summary:

      The purpose of this study was to determine the frequency of bleeding episodes in participants
      receiving fitusiran as prophylactic treatment of hemophilia compared to participants who were
      assigned to continue with their regular medication. In addition, the study assessed safety,
      quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males, greater than or equal to (>=) 12 years of age.

          -  Severe hemophilia A or B with inhibitors.

               -  (Severity confirmed by a central laboratory where coagulation factor VIII (FVIII)
                  level was less than (<)1% or factor IX (FIX) level was less than or equal to
                  [<=]2% at Screening; Inhibitors defined as inhibitor titer of >=0.6 Bethesda
                  units per milliliter [BU/mL] or as evidenced by medical records).

          -  A minimum of 6 bleeding episodes requiring BPA treatment within the last 6 months
             prior to screening.

          -  Willing and able to comply with the study requirements and to provide written informed
             consent and assent.

        Exclusion Criteria:

          -  Known co-existing bleeding disorders other than hemophilia A or B.

          -  Antithrombin (AT) activity <60% at Screening.

          -  Co-existing thrombophilic disorder.

          -  Clinically significant liver disease.

          -  Active hepatitis C virus infection.

          -  HIV positive with a cluster of differentiation-4 count of <200 cells/microliter.

          -  History of arterial or venous thromboembolism.

          -  Inadequate renal function.

          -  History of multiple drug allergies or history of allergic reaction to an
             oligonucleotide or N-Acetylgalactosamine.

          -  History of intolerance to SC injection(s).

          -  Any other conditions or comorbidities that would make the participant unsuitable for
             enrollment or could interfere with participation in or completion of the study, per
             Investigator judgement.
Study of OTO-104 in Subjects With Unilateral Meniere's Disease
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Intervention: OTO-104; Placebo
Intervention description: Single intratympanic injection of 12 mg OTO-104; Single intratympanic injection of placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 176.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Meniere's Disease; Vertigo

Summary:

      The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of
      Meniere's disease.
    

Eligibility criteria:

        Inclusion Criteria includes, but is not limited to:

          -  Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of
             Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo
             for the 2 months prior to the study lead-in period.

          -  Subject has experienced active vertigo during the lead-in period.

          -  Subject has documented asymmetric sensorineural hearing loss.

          -  Subject agrees to maintain their current treatments for Meniere's disease while
             on-study.

        Exclusion Criteria includes, but is not limited to:

          -  Subject is pregnant or lactating.

          -  Subject has a history of immunodeficiency disease.

          -  Subject has a history of previous endolymphatic sac surgery.

          -  Subject has a history of previous use of intratympanic (IT) gentamicin in the affected
             ear.

          -  Subject has a history of tympanostomy tubes with evidence of perforation or lack of
             closure.

          -  Subject has experienced an adverse reaction to IT injection of steroids.

          -  Subject has used an investigational drug or device in the 3 months prior to screening.

          -  Subject has previously been randomized to a trial of OTO-104.
A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: SAGE-217; Matching Placebo; Sertraline; Escitalopram; Citalopram; Duloxetine; Desvenlafaxine
Intervention description: Oral capsules; Oral capsules; Oral tablets; Oral tablets; Oral tablets; Oral capsules; Oral tablets
Intervention MeSH terms: Duloxetine Hydrochloride; Citalopram; Sertraline; Desvenlafaxine Succinate; Escitalopram
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 440.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; MDD; SAGE-217

Summary:

      The primary purpose of this study is to evaluate the efficacy of SAGE-217 plus an ADT in the
      treatment of major depressive disorder (MDD) compared to placebo plus an ADT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of MDD as diagnosed by Structured Clinical Interview for Diagnostic and
             Statistical Manual of Mental Disorders, Fifth Edition Clinical Trials Version
             (SCID-5-CT), with symptoms that have been present for at least a 4-week period

          -  17-item Hamilton Rating Scale for Depression (HAM-D-17) total score of ≥24 at
             Screening and Day 1

          -  Participant in good physical health and has no clinically significant findings, as
             determined by the investigator, on physical examination, 12-lead electrocardiogram
             (ECG), or clinical laboratory tests

          -  Participant is willing, able, and eligible to take at least 1 of the 5 ADTs specified
             in the protocol (an eligible ADT is an ADT that has not been taken during the current
             depressive episode and for which the participant has no contraindications; further, a
             participant is not eligible for citalopram if escitalopram has been taken during the
             current depressive episode, and vice versa)

        Exclusion Criteria:

          -  Has attempted suicide associated with the current episode of MDD

          -  Participant had onset of the current depressive episode during pregnancy or 4 weeks
             postpartum, or the participant has presented for screening during the 6-month
             postpartum period

          -  Participant has treatment-resistant depression

          -  History of bipolar disorder, schizophrenia, and/or schizoaffective disorder

          -  Known allergy to SAGE-217, allopregnanolone, or related compounds

          -  Has taken antidepressants within 30 days prior to Day 1, and/or has taken fluoxetine
             within 60 days prior to Day 1
Vehicle-Controlled Study of SkQ1 as Treatment for Dry-eye Syndrome
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Intervention: SkQ1 Vehicle Solution; SkQ1 Ophthalmic Solution
Intervention description: SkQ1 Ophthalmic Solution Vehicle; SkQ1 Ophthalmic Solution
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment Parallel-group study SkQ1 Ophthalmic Solution versus placebo (vehicle) solution
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 610.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dry Eye; Dry Eye Syndrome; SkQ1; KCS; Keratoconjunctivitis

Summary:

      The purpose of this study is to evaluate whether SkQ1 Ophthalmic Solution is safe and
      effective compared to Vehicle for the treatment of the signs and symptoms of dry eye
      syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 18 years of age;

          -  Provide written informed consent;

          -  Have a subject reported history of dry eye;

          -  Have a history of use of eye drops for dry eye symptoms;

          -  Ocular Discomfort;

          -  Schirmer's Test score;

          -  Have corneal fluorescein staining ;

          -  Have lissamine green conjunctival Staining;

          -  Have a conjunctival redness;

        Exclusion Criteria:

          -  Have been previously exposed to previous SkQ1 Ophthalmic Solution treatment;

          -  Have any clinically significant slit lamp findings at Visit 1;

          -  Be diagnosed with an ongoing ocular infection or active ocular inflammation at Visit
             1;

          -  Have had any ocular and/or lid surgeries within 6 months of Visit 1 or any planned
             over the study period;

          -  Have an uncontrolled systemic disease;

          -  Be a woman who is pregnant, nursing or planning a pregnancy;

          -  Be a woman of childbearing potential who is not using an acceptable means of birth
             control;

          -  Have a known allergy and/or sensitivity to the study drug or its components;

          -  Have a condition or be in a situation which the investigator feels may put the subject
             at significant risk, may confound the study results, or may interfere significantly
             with the subject's participation in the study;

          -  Be currently enrolled in an investigational drug or device study or have used an
             investigational drug or device within 30 days of Visit 1;
Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: Octreotide capsules
Intervention MeSH terms: Octreotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 146.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Octreotide Capsules; Acromegaly; somatostatin receptor ligands (SRLs); Mpowered; OOC-ACM-302

Summary:

      Octreotide capsule is a novel, orally-administered formulation of the commercially-available
      injectable drug octreotide. In a recent phase 3 trial (OPTMAL; NCT03252353), oral octreotide
      capsules demonstrated sustained biochemical response up to 13 months in patients with
      acromegaly previously managed with somatostatin analog injections (ref).

      The objective of this study was to compare the efficacy, safety, and patient reported
      outcomes (PROs) between oral octreotide capsules and injectable somatostatin receptor ligands
      (SRLs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of acromegaly

          -  Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least
             6 months

          -  Biochemical control (IGF -1 < 1.3 x ULN and GH < 2.5ng/mL)

        Exclusion Criteria:

          -  Injections of long-acting somatostatin analogs, at a dosing interval > 8 weeks.

          -  Pituitary radiotherapy within 5 years

          -  Pituitary surgery within six months

          -  Patients who previously participated in CH-ACM-01 study

          -  Any clinically significant uncontrolled concomitant disease

          -  Symptomatic cholelithiasis

          -  Previous treatment with:

          -  Pegvisomant, within 12 weeks

          -  Dopamine agonists, within 6 weeks

          -  Pasireotide, within 12 weeks
A Study to Evaluate Upadacitinib in Adolescents and Adults With Moderate to Severe Atopic Dermatitis (Measure Up 2)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Placebo for Upadacitinib; Upadacitinib
Intervention description: Tablets taken orally once a day; Tablets taken orally once a day
Intervention MeSH terms: Upadacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 912.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis; Upadacitinib; ABT-494; Measure Up 2

Summary:

      The objective of this study is to assess the efficacy and safety of upadacitinib for the
      treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD)
      who are candidates for systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight of ≥ 40 kg at Baseline Visit for participants ≥ 12 and < 18 years of age

          -  Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to
             Baseline and subject meets Hanifin and Rajka criteria

          -  Active moderate to severe AD defined by Eczema Area and Severity Index (EASI) ≥ 16,
             validated Investigator's Global Assessment (vIGA) ≥ 3, body surface area (BSA)
             affected by AD ≥ 10%, and weekly average of daily Worst Pruritus numerical rating
             scale (NRS) score ≥ 4.

          -  Candidate for systemic therapy or have recently required systemic therapy for AD

          -  Documented history (within 6 months prior to Baseline) of inadequate response to
             topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) or documented
             systemic treatment for AD or for whom topical treatments are otherwise medically
             inadvisable due to side effects or safety risks

        Exclusion Criteria:

          -  Prior exposure to any Janus kinase (JAK) inhibitor

          -  Unable or unwilling to discontinue current AD treatments prior to the study

          -  Requirement of prohibited medications during the study

          -  Other active skin diseases or skin infections requiring systemic treatment or would
             interfere with appropriate assessment of atopic dermatitis lesions

          -  Female subject who is pregnant, breastfeeding, or considering pregnancy during the
             study
Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in Human Immunodeficiency Virus-1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Condition: HIV-1 Infection
Intervention: ABC/DTG/3TC; B/F/TAF; ABC/DTG/3TC Placebo; B/F/TAF Placebo
Intervention description: 600/50/300 milligrams (mg) tablets administered orally, once daily; 50/200/25 mg tablets administered orally, once daily, without regard to food; Tablets administered orally, once daily; Tablets administered orally, once daily
Intervention MeSH terms: Lamivudine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 631.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV

Summary:

      The primary objective of this study is to evaluate the efficacy of a fixed dose combination
      (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus a FDC
      containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral
      treatment naive-adults.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral
             agent following a diagnosis of HIV-1 infection) except the use for pre-exposure
             prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to
             screening

          -  Plasma HIV-1 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at
             screening

          -  Adequate renal function: Estimated glomerular filtration rate ≥ 50 milliliter per
             minute (mL/min) (≥ 0.83 milliliter per second [mL/sec]) according to the
             Cockcroft-Gault formula

          -  Negative screening test for human leukocyte antigen (HLA) -B x 5701 allele provided by
             Gilead Sciences

        Key Exclusion Criteria:

          -  An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior
             to screening (refer to study protocol)

          -  Decompensated cirrhosis (e.g, ascites, encephalopathy, or variceal bleeding)

          -  Current alcohol or substance use judged by the Investigator to potentially interfere
             with subject study compliance

          -  Females who are pregnant (as confirmed by positive serum pregnancy test)

          -  Females who are breastfeeding

          -  Chronic Hepatitis B Virus (HBV) infection

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Stereotactic Radiology Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-Line Chemotherapy
Condition: Recurrent or Progressive Glioblastoma
MeSH terms: Glioblastoma; Recurrence
Intervention: Bevacizumab; Chemotherapy; Fractionated radiosurgery
Intervention MeSH terms: Bevacizumab; Carboplatin; Irinotecan; Etoposide; Temozolomide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: glioblastoma

Summary:

      This clinical trial is a prospective study of radiosurgery treatment for progressive GBM to
      test 1)the efficacy of radiosurgery for recurrent/progressive GBM compared to chemotherapy ,
      and 2) the role of diffusion-weighted image (DWI) to predict the early tumor progression and
      treatment response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven intracranial glioblastoma multiforme with pathologic or imaging
             confirmation of tumor progression or regrowth after failure of two previous treatment
             regimens

          -  Initial low-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma

          -  History and physical exam, including neurologic examination, within 4 weeks prior to
             registration

        Exclusion Criteria:

        • Warfarin or LMW heparin patients must have no active bleeding or pathological condition
        that carries a high risk of bleeding
A Safety Study of Galcanezumab in Participants With Migraine, With or Without Aura
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Galcanezumab
Intervention description: Administered SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: prevention; prophylaxis; headache

Summary:

      The main purpose of this study is to evaluate the longer term safety of the study drug known
      as galcanezumab in participants with episodic or chronic migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of episodic or chronic migraine as defined by International Headache
             Society (IHS) International Classification of Headache Disorders (ICHD)-3 beta
             guidelines (1.1, 1.2 or 1.3) (ICHD-3 2013), with a history of migraine headaches of at
             least 1 year prior to screening, and migraine onset prior to age 50.

          -  Prior to baseline, a history of 4 or more migraine headache days per month on average
             for the past 3 months.

        Exclusion Criteria:

          -  Are currently enrolled in or have participated within the last 30 days or within 5
             half-lives (whichever is longer) in a clinical trial involving an investigational
             product.

          -  Current use or prior exposure to galcanezumab or another CGRP antibody.

          -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
             proteins, or to galcanezumab.

          -  History of persistent daily headache, cluster headache or migraine subtypes including
             hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine
             with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 beta.