bioihbjkbjnl/mcl2 huggingface dataset:
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
Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA
Intervention description: Fixed-dose combination (FDC) tablet for oral administration.; Tablet for oral administration.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 251.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study evaluated the long-term safety, efficacy, and pharmacodynamics of elexacaftor
      (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in
      subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a gating
      or residual function mutation (F/G and F/RF genotypes).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Completed study drug treatment in parent study (VX18-445-104); or had study drug
             interruption(s) in parent study but completed study visits up to the last scheduled
             visit of the Treatment Period in the parent study

        Key Exclusion Criteria:

          -  History of study drug intolerance in parent study

        Other protocol defined Inclusion/Exclusion criteria may apply.
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: Evolocumab; Placebo
Intervention description: Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.; Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
Intervention MeSH terms: Evolocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 27564.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: High cholesterol; Treatment for high cholesterol; Lowering cholesterol; Lowering high cholesterol; Hypercholesterolemia

Summary:

      The primary objective was to evaluate the effect of treatment with evolocumab, compared with
      placebo, on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization
      for unstable angina, or coronary revascularization, whichever occurs first, in patients with
      clinically evident cardiovascular disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 40 to ≤ 85 years of age

          -  History of clinically evident cardiovascular disease at high risk for a recurrent
             event

          -  Fasting low-density lipoprotein cholesterol (LDL-C) ≥ 70 mg/dL (≥ 1.8 mmol/L) ) or
             non-high-density lipoprotein cholesterol (non-HDL-C) ≥ 100 mg/dL (> 2.6 mmol/L)

          -  Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

        Exclusion Criteria:

          -  New York Heart Association (NYHA) class III or IV, or last known left ventricular
             ejection fraction < 30%

          -  Uncontrolled hypertension

          -  Uncontrolled or recurrent ventricular tachycardia

          -  Untreated hyperthyroidism or hypothyroidism

          -  Homozygous familial hypercholesterolemia

          -  LDL or plasma apheresis
Randomized Safety Study of CVT-301 Compared to an Observational Control Group
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: CVT-301; Observational cohort
Intervention MeSH terms: Levodopa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 408.0
Sex: All
Minimum age: 30 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Motor fluctuations; levodopa; inhaled drugs; OFF episodes

Summary:

      This study is a 12-month, open-label, randomized, multicenter study which will evaluate the
      safety and efficacy of CVT-301 for the treatment of up to 5 OFF episodes per day in
      Parkinson's Disease (PD) patients experiencing motor fluctuations (OFF episodes) and will
      include a concurrent observational cohort of PD patients managed using the usual standards of
      care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has signed and dated an Internal Review Board/Independent Ethics Committee
             (IRB/IEC)-approved informed consent form before any protocol-specific screening
             procedures are performed.

          -  Women of child-bearing potential must use protocol-defined contraceptive measures and
             must have a negative serum human chorionic gonadotropin (hCG) test at screening. These
             patients must be willing to remain on their current form of contraception for the
             duration of the study.

          -  Patients who have idiopathic PD (i.e., not induced by drugs or other diseases) as
             defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria,
             diagnosed after the age of 30 years.

          -  Patients who are classified as Stage 1 to 3 (in the ON state) on the modified Hoehn
             and Yahr scale for staging of PD severity.

          -  Patients who have experienced motor fluctuations for a minimum of 2 hours of average
             daily OFF time per waking day (excluding early morning OFF time) by self-report and
             confirmed by the PD Diary (on 3 consecutive days) during the screening period.

        Exclusion Criteria:

          -  Patients who have dyskinesia of a severity that would significantly interfere with
             their ability to participate or perform study procedures.

          -  Pregnant or lactating females or females wishing to become pregnant.

          -  Patients who have any known contraindication to the use of levodopa (LD), including a
             history of malignant melanoma or a history of narrow-angle glaucoma.

          -  Patients who have had previous surgery for PD (including but not limited to deep brain
             stimulation [DBS] or cell transplantation).

          -  Patients with a history of psychotic symptoms requiring treatment, or suicide ideation
             or attempt within the prior 12 months.
Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery
Condition: Thyroidectomy; Thyroid Diseases
MeSH terms: Thyroid Diseases; Nausea; Vomiting
Intervention: Dexamethasone; NaCl 0.9%
Intervention description: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery; 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: postoperative nausea and vomitus; PONV; thyroid surgery

Summary:

      The study is to compare the postoperative recovery, as determined by postoperative nausea and
      vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in
      patients undergoing partial or total thyroidectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age > 18

          -  Planned partial or total thyroidectomy

        Exclusion Criteria:

          -  History of adverse effects to dexamethasone or propyleneglycol or di-natrium-EDTA

          -  Patients with chronic pain

          -  Necessity for opioids-application in the postoperative course

          -  Not possible administration of a cervical block (0.5% bupivacaine at a dose of 20ml)

          -  Patients with Diabetes mellitus

          -  Pregnancy (test in young women)

          -  Glaucoma

          -  Patients who received antiemetic therapy within 48h before surgery

          -  Patients with acute pain requiring painkillers others than paracetamol or more than
             single dose NSAR treatment within 48h before surgery

          -  Use of psychotropic drugs

          -  Incompliant patients

          -  Preoperatively high suspicion of malignancy

          -  Re-operations
Aspirin for Exercise in Multiple Sclerosis (ASPIRE)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Aspirin 650mg Oral Capsule; Acetaminophen Tablet 650mg; Placebo
Intervention description: A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.; A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.; A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.
Intervention MeSH terms: Aspirin; Acetaminophen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a within-subject design double-blind RCT in which each participant receives 1 of 3 treatments at 3 timepoints (i.e., 3 separate days separated by 1-week washout periods).
Masking: Single (Outcomes Assessor)
Masking description: Study biostatistician will derive the randomization schedule. Study pharmacy will make assignments and maintain blinding until data analysis is complete for the full sample.
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: exercise; aspirin; cooling; antipyretic

Summary:

      This study investigates the use of aspirin as an exercise pre-treatment to reduce overheating
      and exhaustion, which may potentially allow many more people with multiple sclerosis to
      participate in and benefit from exercise. The design is double-blind, within-subject, with
      three arms: participants will receive one of three treatments at three separate study visits:
      aspirin, acetaminophen, and placebo, followed by completion of a maximal exercise test.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of relapsing-remitting MS

          -  self-reported heat-sensitivity to exercise

          -  Expanded Disability Status Scale (EDSS) total score ≤ 6.0

          -  exacerbation-free (and no use of corticosteroids) for 6 weeks prior

          -  BMI ≤ 40

        Exclusion Criteria:

          -  prior history of significant head injury, stroke, or other neurological
             disease/disorder

          -  current daily use of antipyretics or pain medication

          -  currently in a major depressive episode

          -  vascular disease of the legs, uncontrolled high blood pressure

          -  uncontrolled diabetes mellitus or problem with blood sugar levels

          -  contraindications to aspirin use (history of confirmed peptic ulcer, gastrointestinal
             or severe gynecological bleeding)

          -  tarry stool or known fecal occult blood

          -  uncontrolled syndrome of asthma, rhinitis, or nasal polyps

          -  contraindications to acetaminophen use (severe active hepatic disease, Hepatitis C
             Virus)
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Dexamethasone; Sham
Intervention description: 350 µg or 700 µg dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.; Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 494.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone
      for the treatment of diabetic macular edema.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  18 years of age or older with diabetic macular edema;

          -  Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or
             worse);

          -  Visual acuity in other eye no worse than 20/200

        Key Exclusion Criteria:

          -  Known anticipated need for ocular surgery within first 12 months of study;

          -  History of glaucoma or current high eye pressure requiring more than 1 medication;

          -  Uncontrolled systemic disease;

          -  Known steroid-responder;

          -  Use of systemic steroids

          -  Use of Warfarin/Heparin
Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Comparator: montelukast/loratadine; Comparator: montelukast; Comparator: loratadine; Comparator: placebo
Intervention description: montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks; montelukast 10 mg tablet taken once daily at bed time for 2 weeks; loratadine 10 mg tablet taken once daily at bed time for 2 weeks; placebo tablet taken once daily at bed time for 2 weeks
Intervention MeSH terms: Loratadine; Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 907.0
Sex: All
Minimum age: 15 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study will evaluate the ability of oral montelukast/loratadine to improve the signs and
      symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a documented history of seasonal allergic rhinitis symptoms that flare up
             during the study season

          -  Patient is a nonsmoker

          -  Patient is in good general health

        Exclusion Criteria:

          -  Patient is hospitalized

          -  Patient is a woman who is less than 8 weeks postpartum or is breast-feeding

          -  Patient intends to move or vacation away during the study

          -  Patient has had any major surgery within 4 weeks of study start

          -  Patient is a current or past abuser of alcohol or illicit drugs

          -  Patient has been treated in an emergency room for asthma in the past month

          -  Patient had an upper respiratory infection with in 3 weeks prior to study start

          -  Patient has any active pulmonary disorder other than asthma
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy
Condition: Hepatitis C
MeSH terms: Infections; Hepatitis C; Hepatitis
Intervention: SOF/VEL/VOX; SOF/VEL
Intervention description: 400/100/100 mg tablet administered orally once daily with food; 400/100 mg tablet administered orally once daily with or without food
Intervention MeSH terms: Sofosbuvir; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 943.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C Infection

Summary:

      The primary objectives of this study are to compare the efficacy, safety, and tolerability of
      treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC)
      for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive
      participants with chronic hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  Chronic HCV infection (≥ 6 months)

          -  HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen

          -  Use of protocol specified methods of contraception

        Key Exclusion Criteria:

          -  Current or prior history of clinically significant illness that may interfere with
             participation in the study

          -  Screening ECG with clinically significant abnormalities

          -  Laboratory parameters outside the acceptable range at screening

          -  Pregnant or nursing female

          -  Chronic liver disease not caused by HCV

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Subjects
Condition: Surgery
Intervention: Chlorhexidine Gluconate; Vehicle; DynaHex-2
Intervention description: 2% CHG solution on cloth; Excipients of CHG product only; 2% CHG solution
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 347.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Preoperative surgical skin preparation

Summary:

      Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on
      the skin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or Females

          -  16 years of age or older

          -  Signed informed consent

          -  Good Health

          -  Six inches of abdomen and groin areas without tattoos, or skin disorders

        Exclusion Criteria:

          -  Dermatological Conditions

          -  Sensitivity to latex

          -  Sensitivity to CHG