bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms
Condition: Benign Prostatic Hyperplasia; Enlarged Prostate
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Tadalafil; Placebo; Finasteride
Intervention description: 5 milligrams (mg) administered orally, once daily for 26 weeks; Administered orally, once daily for 26 weeks; 5mg administered orally, once daily for 26 weeks
Intervention MeSH terms: Tadalafil; Finasteride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 696.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Benign Prostatic Hyperplasia (BPH); Enlarged Prostate

Summary:

      The purpose of this study is to investigate the efficacy and safety of once daily tadalafil
      when taken with finasteride as a treatment for men with signs and symptoms of Benign
      Prostatic Hyperplasia and demonstrable prostate enlargement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have not taken the following treatments within the indicated duration and agree not to
             use at any time during the study:

               -  All other Benign Prostatic Hyperplasia (BPH) therapy (including herbal
                  preparations) for at least 4 weeks prior to receiving study medication.

               -  Overactive bladder therapy (including antimuscarinics) for at least 4 weeks prior
                  to receiving study medication.

               -  Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks
                  prior to receiving study medication.

               -  Finasteride or dutasteride use at any time.

          -  Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of
             greater than or equal to 4 and less than or equal to 15 milliliters (mL)/second before
             receiving study drug.

          -  Have prostate enlargement measured by ultrasound at screening.

        Exclusion Criteria:

          -  Have prostate cancer, are being treated for cancer or have clinical evidence of
             prostate cancer [Prostate-specific antigen (PSA) greater than 10 nanograms/milliliter
             (ng/mL) at the start of study].

          -  Have had any of the following in the past 90 days: Heart attack, also known as a
             myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft
             surgery); Had a procedure to open up blood vessels in the heart known as angioplasty
             or stent placement (percutaneous coronary intervention).

          -  Have problems with kidneys, liver, or nervous system

          -  Have uncontrolled diabetes

          -  Have had a stroke or a significant injury to brain or spinal cord.

          -  Have scheduled or planned surgery during the course of the study.
A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: ALKS 3831
Intervention description: Tablets were administered for daily dosing
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 281.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Alkermes; ALKS 3831; Samidorphan; Schizophrenia; Safety

Summary:

      The primary objective of this study is to evaluate the long term safety and tolerability of
      ALKS 3831 in subjects with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has completed the 4-week treatment period (all visits up to and including end
             of treatment visit) in the antecedent study ALK3831-A305 within 7 days.

          -  Agrees to use an acceptable method of contraception for the duration of the study.

          -  Additional criteria may apply.

        Exclusion Criteria:

          -  Subject is currently taking medications that are contraindicated with olanzapine use.

          -  Subject has a positive test for drugs of abuse at study entry.

          -  Subject is pregnant, planning to become pregnant, or breastfeeding during the study.

          -  Additional criteria may apply.
Long Term Administration Study of OPC-12759 Ophthalmic Suspension
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: OPC-12759 Ophthalmic suspension
Intervention description: Instillation,4times/day,for 52weeks
Intervention MeSH terms: Rebamipide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate safety and efficacy of OPC-12759 ophthalmic
      suspension during 52 weeks in dry eye patients
    

Eligibility criteria:

        Inclusion Criteria:

          1. Out patient;

          2. Ocular discomfort severity is moderate to severe;

          3. Corneal-conjunctival damage is moderate to severe;

          4. Unanesthetized Schirmer's test score of 5mm/5minutes or less,or tear breakup time is 5
             seconds or less;

          5. Best corrected visual acuity of 0.2 or better in both eyes.

        Exclusion Criteria:

          1. Presence of anterior segment disease or disorder other than that associated with
             keratoconjunctivitis scicca;

          2. Ocular hypertention patient or glaucoma patient with ophthalmic solution;

          3. Anticipated use of any topically-instilled ocular medications or patients who cannot
             discontinue the use during the study;

          4. Anticipated use of contact lens during the study;

          5. Patient with punctal plug;

          6. Any history of ocular surgery within 12 months;

          7. Female patients who are pregnant, possibly pregnant or breast feeding;

          8. Known hypersensitivity to any component of the study drug or procedual medications;

          9. Receipt of any investigational product within 4 months.
A Study to Compare the Efficacy and Safety of Topical Administration of FMX-101 for Treatment of Moderate-to-Severe Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: FMX-101, 4% minocycline foam; Vehicle Foam
Intervention description: FMX-101, 4% minocycline foam applied topically once daily for 12 weeks; Vehicle foam applied topically once daily for 12 weeks
Intervention MeSH terms: Minocycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 495.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No
Keywords: acne

Summary:

      This is a Phase 3 study to evaluate the efficacy, safety and long-term safety of the topical
      administration of FMX-101, 4% minocycline foam for the treatment of moderate-to-severe acne
      vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has facial acne vulgaris with:

               -  20 to 50 inflammatory lesions (papules, pustules, and nodules)

               -  25 to 100 noninflammatory lesions (open and closed comedones)

               -  No more than 2 nodules on the face

               -  IGA score of moderate (3) to severe (4)

          -  Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin
             Cleanser) and to refrain from use of any other acne medication, medicated cleanser,
             excessive sun exposure, and tanning booths for the duration of the study

        Exclusion Criteria:

          -  Acne conglobata, acne fulminans, secondary acne (chloracne, drug induced acne) or any
             dermatological condition of the face or facial hair (eg, beard, sideburns, mustache)
             that could interfere with the clinical evaluations

          -  Sunburn on the face
Maximizing Outcomes in Treating Acute Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: AXS-07 (MoSEIC meloxicam and rizatriptan); Meloxicam; Rizatriptan; Placebo
Intervention description: AXS-07 taken once upon onset of a qualifying migraine.; Meloxicam taken once upon onset of a qualifying migraine.; Rizatriptan taken once upon onset of a qualifying migraine.; Placebo taken once upon onset of a qualifying migraine.
Intervention MeSH terms: Meloxicam; Rizatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1594.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine; AXS-07; Meloxicam; Rizatriptan; Axsome; Axsome Therapeutics; MoSEIC meloxicam

Summary:

      AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan,
      which is being developed for the acute treatment of migraine with or without aura in adults.
      AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This
      study is designed to evaluate the efficacy and safety of AXS-07 compared to meloxicam,
      rizatriptan, and placebo for the treatment of a migraine attack.

      This is a randomized, double-blind, 4-arm, parallel group, single-dose, placebo-controlled
      trial. Subjects who successfully complete screening and continue to meet all entry criteria
      will be randomly assigned to take one dose of either AXS-07, meloxicam, rizatriptan, or
      placebo upon the occurrence of a qualifying migraine.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Has an established diagnosis of migraine with or without aura.

          -  Has experienced an inadequate response to prior acute treatments.

        Key Exclusion Criteria:

          -  Has previously received any investigational drug or device or investigational therapy
             within 30 days before Screening.

          -  Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the
             study.
Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Filgotinib; Placebo to match filgotinib; MTX; Placebo to match MTX
Intervention description: Tablet(s) administered orally once daily; Tablet(s) administered orally once daily; Capsule(s) administered orally once weekly; Capsule(s) administered orally once weekly
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1252.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the effects of filgotinib in combination
      with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Have a diagnosis of RA (2010 American College of Rheumatology [ACR]/European League
             Against Rheumatism [EULAR] criteria) and are ACR functional class I-III.

          -  Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and ≥
             6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both
             screening and Day 1.

          -  Limited or no prior treatment with MTX

        Key Exclusion Criteria:

          -  Previous treatment with any janus kinase (JAK) inhibitor

          -  Previous therapy for longer than 3 months with conventional synthetic disease
             modifying antirheumatic drugs (csDMARDs) other than MTX or hydroxychloroquine

          -  Use of any licensed or investigational biologic disease-modifying antirheumatic drugs
             (DMARDs)

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of the Safety and Effectiveness of Rabeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: rabeprazole; rabeprazole
Intervention description: 0.5mg/kg once daily for 12 weeks plus option for F/u another 24 weeks; 1.0 mg/kg once daily for 12 weeks plus option for F/u another 24 weeks
Intervention MeSH terms: Rabeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 127.0
Sex: All
Minimum age: 1 Year
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Gastroesophageal Reflux Disease (GERD); Erosive Gastroesophageal Reflux Disease; Ulcerative Gastroesophageal Reflux Disease; Endoscopy; Pediatrics; Rabeprazole

Summary:

      The purpose of the study is to access the effectiveness and safety of oral rabeprazole in the
      treatment of acid-related disorders in pediatric patients, focusing specifically on the
      manifestation of GERD (symptomatic and erosive types).
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of at least 1 Gastroesophageal Reflux Disease (GERD) symptom within 3 months
             of screening

          -  Positive esophagogastroduodenoscopy

          -  Signed informed consent

          -  Female patients (if menstruating) must be practicing birth control

        Exclusion Criteria:

          -  Patients with history of esophagitis

          -  Patients who have milk protein allergy

          -  Patients who have taken Proton Pump Inhibitors or H2-blockers within 3 days

          -  Patients who have taken sucralate or any medication that affects gastrointestinal
             motility

          -  Patients with H. pylori

          -  Patients with lab values outside the normal age appropriate range

          -  Patients who have participated in another trial within 30 days before screening

          -  Patients with allergies to Proton Pump Inhibitors
Effect of Maraviroc on Endothelial Function in HIV-Infected Patients
Condition: HIV Infection; Cardiovascular Disease; Inflammation; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Cardiovascular Diseases; Inflammation
Intervention: Maraviroc; placebo
Intervention description: For subjects assigned to the maraviroc group, they will receive maraviroc at 300mg by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications. For subjects on ritonavir, the dose will be reduced to 150mg by mouth twice daily for 24 weeks.; For subjects assigned to the placebo group, they will receive a matching placebo pill 300mg to be taken by mouth twice daily for 24 weeks in addition to taking their current anti-HIV medications.
Intervention MeSH terms: Maraviroc
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment Experienced; CCR5 receptor; maraviroc

Summary:

      The purpose of this study is to determine the potentially beneficial aspects of CCR5
      inhibition on inflammation and endothelial function as measured by brachial artery reactivity
      in antiretroviral treated HIV patients with an undetectable viral load.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Stable antiretroviral therapy for at least 12 months

          2. All plasma HIV RNA levels within the past year must be below level of detection (< 50
             copies RNA/mL), although isolated single values > 50 but < 200 copies will be allowed.

          3. Screening plasma HIV RNA levels < 50 copies RNA/mL

          4. >90% adherence to therapy within the preceding 30 days, as determined by self-report

          5. Females of childbearing potential must have a negative serum pregnancy test at
             screening and agree to use a double-barrier method of contraception throughout the
             study period.

        Exclusion Criteria:

          1. Ongoing or prior use of any integrase inhibitor or R5 inhibitor.

          2. Patients who plan to modify existing antiretroviral therapy in the next 24 weeks for
             any reason

          3. Serious illness requiring hospitalization or parental antibiotics within preceding 3
             months

          4. Concurrent or recent exposure to any immunomodulatory drugs

          5. Advanced liver disease or active hepatitis B or C

          6. Patients with systolic blood pressure <100/70

          7. Starting or stopping statin therapy during the trial
Long Term Extension Study of Tapinarof for Plaque Psoriasis in Adults (3003)
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: tapinarof cream, 1%
Intervention description: Intermittent use of Tapinarof cream, 1%, applied once daily according to PGA score
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Subjects in this study completed treatment with tapinarof or vehicle in 1 of 2 parent Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study DMVT-505-3002). The study will consist of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period.
Masking: None (Open Label)
Enrollment: 763.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Tapinarof; plaque psoriasis,; adult; phase 3; topical; open-label; efficacy; safety; psoriasis; long-term; therapeutic aryl hydrocarbon receptor modulating agent

Summary:

      This is a long-term, open-label, multicenter, study to evaluate the safety and efficacy of
      topical tapinarof cream, 1% in adults with plaque psoriasis. Subjects in this study completed
      treatment in 1 of 2 Phase 3 pivotal efficacy and safety studies (Study DMVT-505-3001 or Study
      DMVT-505-3002). This study will consist of up to 40 weeks of treatment and a 4-week safety
      follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Completed the 12-week treatment period in 1 of the 2 parent studies (Study
             DMVT-505-3001 or Study DMVT-505-3002);

          2. Male and female subjects

          3. Females of child bearing potential and male subjects who are engaging in sexual
             activity that could lead to pregnancy agree to follow the specified contraceptive
             guidance while on the study, and for at least 4 weeks after the last exposure to study
             treatment

          4. Capable of giving written informed consent

        Exclusion Criteria:

          1. Used a prohibited concomitant product or procedure to treat psoriasis during parent
             study

          2. Had a serious adverse event (SAE) that was potentially related to treatment or
             experienced an adverse event (AE) that led to permanent discontinuation of treatment
             in the parent study

          3. History of or ongoing serious illness or medical, physical, or psychiatric
             condition(s) that, in the Investigator's opinion, may interfere with the subject's
             completion of the study

          4. Known hypersensitivity to tapinarof
A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)
Condition: Bacterial Infections; Virus Diseases
MeSH terms: Infections; Bacterial Infections; Virus Diseases
Intervention: V419; PENTACEL™; Prevnar 13™; RotaTeq™; Recombivax HB vaccine
Intervention description: V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Outer Membrane Protein Complex], and Hepatitis B [Recombinant] Vaccine) (from one of three lots) 0.5 mL intramuscular injection at 2, 4, and 6 months of age.; PENTACEL™ 0.5 mL intramuscular injection at 15 months of age in the V419 groups and at 2, 4, 6, and 15 months of age in the control group; Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2808.0
Sex: All
Minimum age: 46 Days
Maximum age: 89 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus; Whooping Cough (pertussis); Poliomyelitis; Hepatitis B infection; Haemophilus influenzae type b infection

Summary:

      This study will determine whether three manufacturing lots of V419 (PR5I) induce similar
      immune responses to all of the antigens contained in V419 when given concomitantly with
      Prevnar13™ and RotaTeq™.
    

Eligibility criteria:

        Inclusion Criteria :

          -  Participant is a healthy infant

          -  Participant has received one dose of monovalent hepatitis B vaccine prior to 1 month
             of age

        Exclusion Criteria :

          -  Participant has received more than one dose of monovalent hepatitis B vaccine or
             hepatitis B based combination vaccine prior to study entry

          -  Participant has been vaccinated with any acellular pertussis or whole cell pertussis
             based combination vaccines, haemophilus influenzae type b conjugate, poliovirus,
             pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps,
             rubella, or varicella vaccines or any combination of the above

          -  Participant has had an illness with fever within 24 hours of study enrollment

          -  Participant was vaccinated with any non-study vaccine (i.e. inactivated, conjugated or
             live virus vaccine within 30 days prior to enrollment, except for inactivated
             influenza vaccine, which is permitted 15 days or more prior to enrollment

          -  Participant or his/her mother has hepatitis B surface antigen (HBsAg) seropositivity
             (by medical history)

          -  Participant has a history of haemophilus influenzae type B, hepatitis B, diphtheria,
             tetanus, pertussis, poliomyelitis, rotavirus, or pneumococcal infection