bioihbjkbjnl/mcl2 huggingface dataset:
P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: SB204 4%; Vehicle Gel
Intervention description: Applied topically once daily; Applied topically one daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1330.0
Sex: All
Minimum age: 9 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel
      group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe acne

          -  Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones)
             on the face

          -  Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)

        Exclusion Criteria:

          -  Women of child-bearing potential who are pregnant, nursing, considering becoming
             pregnant

          -  Any dermatologic condition that could interfere with clinical evaluations including
             severe, recalcitrant cystic acne
Evaluation of TRC101 in Subjects With Metabolic Acidosis Associated With Chronic Kidney Disease
Condition: Metabolic Acidosis
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Acidosis
Intervention: TRC101; Placebo
Intervention description: Oral suspension; Oral suspension
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: blood bicarbonate, kidney disease

Summary:

      This is a multicenter, double-blind, placebo-controlled, parallel-design study. The study
      will enroll approximately 210 adult male and female subjects with stage 3 or 4 chronic kidney
      disease and metabolic acidosis. The study dosing (TRC101 or placebo) will continue for 12
      weeks once daily.

      The maximum study duration is anticipated to be up to 16 weeks.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Blood bicarbonate level of 12 to 20 mEq/L.

          -  Estimated glomerular filtration rate (eGFR) of 20 to 40 mL/min/1.73m2.

          -  Stable kidney function defined as <=20% variability in eGFR during screening period.

        Key Exclusion Criteria:

          -  Any level of low blood bicarbonate during the screening period that in the opinion of
             the Investigator, requires emergency intervention or evaluation for an acute acidotic
             process.

          -  Anuria, dialysis, acute kidney injury, or history of acute kidney insufficiency within
             3 months prior to screening.

          -  Heart failure with maximum New York Heart Association (NYHA) Class IV symptoms or that
             required hospitalization during the preceding 6 months.

          -  Heart or kidney transplant.

          -  Chronic obstructive pulmonary disease (COPD) that is treated with chronic oral
             steroids, that requires the subject to be on oxygen, or that required hospitalization
             within the previous 6 months.

          -  Change in doses to alkali therapy in the 4 weeks prior to screening.

          -  History or current diagnosis of diabetic gastroparesis, bowel obstruction, swallowing
             disorders, inflammatory bowel disease, major gastrointestinal surgery, frequent
             diarrhea or active gastric/duodenal ulcers.

          -  Serum calcium <= 8.0 mg/dL at screening.

          -  Planned initiation of renal replacement therapy within 12 weeks following
             randomization.

          -  Use of polymeric binder drugs within 14 days prior to screening.
A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy
Condition: Hyperlipidemias
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Intervention: Bempedoic Acid + Ezetimibe Fixed-Dose Combination; Bempedoic Acid; Ezetimibe; Placebos
Intervention description: bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet; bempedoic acid 180 mg tablet; ezetimibe 10 mg overencapsulated tablet; placebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 382.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hyperlipidemia; heterozygous familial hypercholesterolemia; atherosclerotic cardiovascular disease; high cholesterol; ASCVD; HeFH; LDL

Summary:

      The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a
      fixed-dose combination (FDC) is effective and safe versus its individual components and
      placebo in patients with elevated LDL cholesterol treated with maximally tolerated statin
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Require lipid-modifying therapy for primary or secondary prevention of cardiovascular
             disease

          -  Fasting LDL-C ≥ 130 mg/dL for primary prevention or LDL-C ≥ 100 mg/dL for secondary
             prevention (history of HeFH and/or ASCVD)

          -  Treated with maximally tolerated statin therapy at stable dose for at least 4 weeks
             prior to screening

        Exclusion Criteria:

          -  Total Fasting Triglyceride ≥ 400 mg/dL

          -  Renal Dysfunction or nephrotic syndrome or history of nephritis

          -  Significant cardiovascular disease or cardiovascular event within the past 3 months
Open-label Safety Extension Study Assessing Safety and Tolerability of LAI in Patients Who Participated in Study INS-212
Condition: NTM Lung Infection Due to MAC
MeSH terms: Infections
Intervention: LAI 590 mg; Multi-drug regimen
Intervention description: LAI 590 mg QD: administered by inhaling drug product that had been aerosolized in an investigational eFlow nebulizer over approximately 14 minutes; Multidrug antimycobacterial regimen from study INS-212
Intervention MeSH terms: Amikacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 163.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ALIS; ARIKAYCE

Summary:

      This is an open-label safety extension study to assess the safety and tolerability of once
      daily dosing of 590 mg Liposomal Amikacin for Inhalation (LAI) added to a multi-drug regimen
      in participants with nontuberculous mycobacterial (NTM) lung infections due to Mycobacterium
      avium complex (MAC) who were refractory to therapy and failed to convert in Study INS-212
      (NCT02344004).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. had successfully completed the Month 6 and End of Treatment visits in Study INS-212

          2. had not achieved the INS-212 protocol definition of culture conversion by Month 6 in
             Study INS-212 OR had experienced a relapse or recurrence by Month 6 in Study INS-212.

        Key Exclusion Criteria:

        1. achieved culture conversion without relapse or recurrence in the Study INS-212 study by
        Month 6
Inositol to Reduce Retinopathy of Prematurity
Condition: Retinopathy of Prematurity (ROP)
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Intervention: myo-Inositol 5% Injection; Placebo
Intervention description: Abbott Nutrition Division, Abbott Laboratories is supplying myo-Inositol 5% Injection to the clinical centers for the duration of the trial.
Inositol: myo-Inositol 5% Injection is an isotonic, preservative-free, sterile 5% solution of myo-inositol in water containing 0.5 gm sodium chloride per liter (8.55mM), pH 6.5-7.5. It is administered via IV infusion using syringe pump over 15-30 minutes twice per day at 12-hour intervals at a dose of 80 mg inositol/kg/day (40 mg inositol/kg/dose), which is equivalent to 1.6 mL/kg/day (0.80 mL/kg/dose).; % glucose(dextrose)
Intervention MeSH terms: Inositol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 638.0
Sex: All
Minimum age: 12 Hours
Maximum age: 72 Hours
Healthy volunteers: No
Keywords: Retinopathy; Prematurity; Infant, Newborn, Diseases

Summary:

      This is a Phase 3, randomized, double-masked, placebo-controlled study designed to determine
      the effectiveness of myo-Inositol 5% Injection to increase the incidence of survival without
      severe Retinopathy of Prematurity (ROP) through acute/final ROP determination up to 55 weeks
      postmenstrual age (PMA) in premature infants <28 0/7 weeks' gestation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inborn or out born infants of either gender or any race with best obstetrical estimate
             of gestation <28 weeks (27 6/7 weeks and younger). Gestational age will be determined
             by best obstetrical estimate using the hierarchy of best obstetrical estimate using
             early ultrasound dating, maternal menstrual dating confirmed by examination, or
             neonatal gestational age assessment by physical examination.

          -  Alive at 12 hours.

          -  Age in hours up to 72 hours, although we will seek enrollment as early as feasible
             after consent and 12 hours.

          -  Informed consent signed and dated by parent and/or guardian, which includes likelihood
             of completing follow-up ophthalmic examinations as an outpatient, and long-term
             follow-up.

        Exclusion Criteria

          -  Major congenital malformations

          -  Congenital malformations of the eye identified prior to randomization.

          -  Overt evidence of intrauterine congenital infections ("TORCH") or life threatening
             impairment of renal, hepatic, or cardiac function (considered moribund).
Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)
Condition: Asthma
MeSH terms: Asthma
Intervention: Dupilumab
Intervention description: Pharmaceutical form: Solution for injection Routes of administration: Subcutaneous
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2282.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To evaluate the long-term safety and tolerability of dupilumab in participants with asthma
      who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579,
      EFC13691).

      Secondary Objectives:

      To evaluate the long-term efficacy of dupilumab in participants with asthma who participated
      in a previous dupilumab asthma clinical study.

      To evaluate dupilumab in participants with asthma who participated in a previous dupilumab
      asthma clinical study, with regards to:

        -  Systemic exposure

        -  Anti-drug antibodies

        -  Biomarkers
    

Eligibility criteria:

        Inclusion criteria:

        - Participants with asthma who completed the treatment period in a previous dupilumab
        asthma clinical study (i.e., PDY14192, EFC13579 or EFC13691) or participants with asthma
        who completed the treatment and follow-up periods in previous dupilumab asthma Study
        DRI12544.

        Exclusion criteria:

        - Participants who experienced any hypersensitivity reactions to Investigational Medicinal
        Product (IMP) in the previous dupilumab asthma study, which, in the opinion of the
        Investigator, could indicate that continued treatment with dupilumab, may present an
        unreasonable risk for the participant.

        The above information was not intended to contain all considerations relevant to a
        Participant's potential participation in a clinical trial.
Study to Evaluate the Safety and Efficacy of Emtricitabine and Tenofovir Alafenamide (F/TAF) Fixed-Dose Combination Once Daily for Pre-Exposure Prophylaxis in Men and Transgender Women Who Have Sex With Men and Are At Risk of HIV-1 Infection
Condition: Pre-Exposure Prophylaxis of HIV-1 Infection
MeSH terms: Infections; Communicable Diseases; HIV Infections
Intervention: F/TAF; F/TDF; F/TAF Placebo; F/TDF Placebo
Intervention description: 200/25 mg tablet administered orally once daily; 200/300 mg tablet administered orally once daily; Tablet administered orally once daily; Tablet administered orally once daily
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine tenofovir alafenamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5399.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to assess the rates of HIV-1 infection in Men (MSM)
      and transgender women (TGW) who have sex with men and who are administered daily
      emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate
      (F/TDF) with a minimum follow-up of 48 weeks and at least 50% of participants have 96 weeks
      of follow-up after randomization.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must be at high risk of sexual acquisition of HIV

          -  HIV-1 negative status

          -  MSM and TGW (male at birth) who have at least one of the following:

               -  condomless anal intercourse with at least two unique male partners in the past 12
                  weeks (partners must be either HIV-infected or of unknown HIV status)

               -  documented history of syphilis in the past 24 weeks

               -  documented history of rectal gonorrhea or chlamydia in the past 24 weeks

          -  Adequate renal function: estimated glomerular filtration rate ≥ 60 mL/min according to
             the Cockcroft-Gault formula

          -  Adequate liver and hematologic function:

               -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper
                  limit of normal (ULN) and total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin

               -  Absolute neutrophil count ≥ 1000/mm^3; platelets ≥ 75,000/mm^3; hemoglobin ≥ 10
                  g/dL

        Key Exclusion Criteria

          -  Grade 3 or Grade 4 proteinuria or glycosuria that is unexplained or not clinically
             manageable.

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Condition: Uterine Fibroids; Heavy Menstrual Bleeding
MeSH terms: Leiomyoma; Myofibroma; Menorrhagia; Hemorrhage
Intervention: Estradiol/Norethindrone Acetate; Elagolix
Intervention description: capsules; film-coated tablets
Intervention MeSH terms: Norethindrone; Norethindrone Acetate; Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 433.0
Sex: Female
Minimum age: 18 Years
Maximum age: 51 Years
Healthy volunteers: No
Keywords: Uterine Fibroids; Elagolix; Heavy Menstrual Bleeding; Elagolix Sodium; Elagolix plus Norethindrone Acetate

Summary:

      This is an extension study for women who have already received six months of treatment in the
      phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate
      the long-term efficacy and safety of elagolix administered alone and in combination with
      estradiol/norethindrone acetate for an additional six months in the treatment of heavy
      menstrual bleeding associated with uterine fibroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has completed the 6-Month Treatment Period of their respective Pivotal
             Study (either Study M12-815 or Study M12-817).

          -  Participant did not meet removal criteria in bone mineral density (BMD) decrease in
             the spine, total hip and femoral neck at Month 6 of the Treatment Period of their
             respective Pivotal Study

          -  Participant has negative urine and/or serum pregnancy test(s) results were
             consistently negative during the Treatment Period of their respective Pivotal Study
             and prior to first dose in this study.

          -  Participant's endometrial biopsy from the Month 6 Visit of their respective Pivotal
             Study shows no clinically significant endometrial pathology.

        Exclusion Criteria:

          -  Participant met criteria for removal from therapy in her respective Pivotal Study.

          -  Participant is planning a pregnancy within the next 18 months.

          -  Participant has current suicidal markers as noted at the Month 6 visit of her
             respective pivotal study.

          -  Participant has any new medical conditions that may be unsuitable for participation.

          -  Participant is using any systemic corticosteroids for over 14 days or is likely to
             require treatment with systemic corticosteroids during the course of the study.
             Over-the-counter and prescription topical, inhaled, intranasal or injectable (for
             occasional use) corticosteroids are allowed.
Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery.
Condition: Nephrolithiasis
MeSH terms: Nephrolithiasis; Kidney Calculi
Intervention: Ketorolac Oral Tablet [Toradol]; Acetaminophen; Oxycodone Acetaminophen
Intervention description: Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.; Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.; Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.
Intervention MeSH terms: Acetaminophen; Ketorolac; Ketorolac Tromethamine; Acetaminophen, hydrocodone drug combination; Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be an open label, prospective study of approximately 112 subjects undergoing either ureteroscopy or percutaneous nephrolithotomy. Patients who are eligible and choose to undergo ureteroscopy or percutaneous nephrolithotomy will then be asked if they would like to participate in the study and informed consent will be obtained. Patients will then be randomized to control (opioid analgesia) or non-opioid analgesia groups, and given this medication at discharge.
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain Outcomes; Ureteroscopy; Percutaneous Nephrolithotomy; Opioids

Summary:

      There are two options for postoperative pain management: opioid and non-opioid analgesia.
      Pain outcomes will be compared in patients undergoing ureteroscopy and percutaneous
      nephrolithotomy by randomly administering opioid and non-opioid analgesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and Women age>18 years old

          -  Presence of renal or ureteral stones suitable for ureteroscopy or percutaneous
             nephrolithotomy.

          -  Uncomplicated ureteroscopy or percutaneous nephrolithotomy

        Exclusion Criteria:

          -  Pregnant/Breastfeeding/Possibly Pregnant Patients

          -  Pediatric Patients

          -  Sensitive or Allergic to Opioids, Ketorolac, or Acetaminophen

          -  Significant Renal Disease

          -  Peptic Ulcer Disease

          -  Chronic Pain and recovering opiate use

          -  Inability to complete questionnaires

          -  Non-mobile patients

          -  Patients on methadone
A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: IW-3718; placebo; Standard-dose PPIs QD
Intervention description: oral tablet; oral tablet; background therapy
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: 18 Years
Healthy volunteers: No
Keywords: Gastroesophageal Reflux Disease; GERD; Proton Pump Inhibitors; IW-3718

Summary:

      The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to
      patients with GERD who continue to have persistent symptoms, such as heartburn and
      regurgitation, while receiving once-daily (QD), standard-dose PPIs.
    

Eligibility criteria:

        Inclusion Criteria:

        Each patient must meet all of the following criteria to be eligible for enrollment in this
        study:

          -  Patient is an ambulatory male or female (if female, nonpregnant) and is at least 18
             years old at the Screening Visit.

          -  Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or
             regurgitation) while taking standard PPI therapy.

          -  Patient has evidence of pathological acid reflux.

          -  Female patients must not be pregnant and must agree to avoid pregnancy for the
             duration of the study.

          -  Patient must comply with study procedures.

        Exclusion Criteria:

        Patients who meet any of the following criteria will not be eligible to participate in the
        study:

          -  Patient has a history of complete lack of GERD symptom response to PPI therapy.

          -  Patient has a significant medical or surgical history including conditions that would
             impact drug absorption or metabolism (such as bowel obstruction, poorly controlled
             diabetes, gastroparesis, hiatal hernia).

          -  Patient reports pain or burning behind the breastbone or in the center of the upper
             stomach as his or her predominant symptom at the Screening Visit.

          -  Patient has received an investigational drug during the 30 days before the Screening
             Visit, or is planning to receive another investigational drug or use an
             investigational device at any time during the study.

        NOTE: Other inclusion and exclusion criteria apply, per the study protocol.