bioihbjkbjnl/mcl2 huggingface dataset:
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Intervention: RGN-259; Placebo
Intervention description: A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days; It is composed of the same excipients as RGN-259 but does not contain Tβ4
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 601.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dry Eye Syndrome; Dry Eye; DES

Summary:

      The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic
      Solutions to placebo for the treatment of the signs and symptoms of dry eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 18 years of age;

          -  Provide written informed consent;

          -  Have a subject reported history of dry eye for at least 6 months

          -  Have a history of use or desire to use eye drops for dry eye symptoms within 6 months

        Exclusion Criteria:

          -  Have any clinically significant slit-lamp findings at Visit 1 that may include active
             blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active
             ocular allergies that require therapeutic treatment, and/or in the opinion of the
             investigator may interfere with study parameters;

          -  Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active
             ocular inflammation at Visit 1;

          -  Have ab uncontrolled systemic disease:
A Study to Evaluate Efficacy and Safety of SAGE-547 in Participants With Severe Postpartum Depression (547-PPD-202B)
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Intervention: Placebo; SAGE-547 60 μg/kg/h; SAGE-547 90 μg/kg/h
Intervention description: Intravenous infusion of matching placebo for either SAGE-547 60 μg/kg/h or 90 μg/kg/h.; Intravenous infusion of SAGE-547.; Intravenous infusion of SAGE-547.
Intervention MeSH terms: Pregnanolone; Brexanolone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 138.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Severe Postpartum Depression; SAGE-547

Summary:

      The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up
      to 90 micrograms per kilogram per hour (μg/kg/h) for 60 hours reduces depressive symptoms in
      participants with severe postpartum depression (PPD) compared to placebo injection as
      assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total
      score.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participants must have ceased lactating at screening; or if still lactating or
             actively breastfeeding at screening, agreed to temporarily cease giving breastmilk to
             their infant(s) from just prior to receiving study drug through nine days (Day 12)
             after the end of the infusion

          -  Participants had a major depressive episode that began no earlier than the third
             trimester and no later than the first 4 weeks following delivery, as diagnosed by
             Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)

          -  Participant had a HAM-D total score of ≥26 at screening and Day 1 (prior to dosing)

          -  Participant was ≤6 months postpartum at screening

          -  Participant was amenable to IV therapy

        Key Exclusion Criteria:

          -  Active psychosis

          -  Attempted suicide associated with index case of postpartum depression

          -  Medical history of bipolar disorders, schizophrenia, and/or schizoaffective disorder.

        Note: Other protocol-defined inclusion/exclusion criteria applied.
Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat
Condition: Moderate to Severe Convexity of Submental Fat; Safety; Efficacy
Intervention: Deoxycholic Acid; Placebo
Intervention description: Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.; Phosphate buffered saline placebo for injection.
Intervention MeSH terms: Deoxycholic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objectives of this study are to explore the safety and efficacy of subcutaneous
      injections of Deoxycholic Acid relative to placebo, in the submental area in patients with
      mild or extreme fullness of the submental fat and ratings of 1 or 4.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects, 18 to 65 years old

          -  Stable Body weight

          -  Body Mass Index (BMI) of ≤40.0 kg/m^2

          -  Acceptable volume of submental fat graded by clinician

          -  Dissatisfaction with the submental area expressed by the subject

          -  Signed informed consent form (ICF)

          -  SMF ratings of 1 or 4

        Exclusion Criteria:

          -  No prior intervention for submental fat (SMF) (eg, liposuction, surgery, or lipolytic
             agents)

          -  Presence of clinically significant health problems

          -  History of trauma associated with the chin or neck areas that in the judgment of the
             investigator may affect evaluation of safety or efficacy of treatment

          -  Body mass index ≤40 kg/m^2
A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833)
Condition: Hypercholesterolemia; Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Ezetimibe; Rosuvastatin
Intervention MeSH terms: Rosuvastatin Calcium; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The study will assess the safety and tolerability of Ezetimibe 10 mg+ Rosuvastatin 2.5 mg and
      Ezetimibe 10 mg+ Rosuvastatin 5.0 mg for up to 52 weeks in Japanese participants with
      hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Rosuvastatin up to 5
      mg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese

          -  Outpatient with hypercholesterolemia

          -  Female participant who is of reproductive potential has to agree to remain abstinent
             or use (or partner use) two acceptable methods of birth control from date of signed
             informed consent to the 14 days after the last dose of study drug

          -  Will maintain a stable diet that is consistent with the Japan Atherosclerosis Society
             Guideline 2012 (JAS 2012) for prevention of atherosclerotic cardiovascular diseases
             for the duration of the study

        Exclusion Criteria:

          -  Uncontrolled hypertension (treated or untreated)

          -  Uncontrolled type 1 or type 2 diabetes mellitus

          -  Homozygous Familial Hypercholesterolemia or has undergone low-density lipoprotein
             (LDL) apheresis

          -  Uncontrolled endocrine or metabolic disease known to influence serum lipids or
             lipoproteins

          -  Has had a gastrointestinal tract bypass, or other significant intestinal malabsorption

          -  History of cancer within the past 5 years (except for successfully treated
             dermatological basal cell or squamous cell carcinoma or in situ cervical cancer)

          -  Human Immunodeficiency Virus (HIV) positive

          -  History of drug/alcohol abuse within the past 5 years or psychiatric illness not
             adequately controlled and stable on pharmacotherapy

          -  Consumes more than 25 g of alcohol per day

          -  Currently following an excessive weight reduction diet

          -  Currently engages in a vigorous exercise regimen (e.g.; marathon training, body
             building training etc.) or intends to start training during the study

          -  Hypersensitivity or intolerance to Ezetimibe or Rosuvastatin

          -  Myopathy or rhabdomyolysis with Ezetimibe or any statin

          -  Pregnant or lactating

          -  Taking any other investigational drugs and/or has taken any investigational drugs
             within 30 days
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: 609.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastroesophageal Reflux Disease; GERD; Proton Pump Inhibitor; 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.
Safety and Efficacy of Bexagliflozin Compared to Glimepiride as Add-on Therapy to Metformin in Type 2 Diabetes Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Bexagliflozin; Placebo for Bexagliflozin; Glimepiride; Placebo for Glimepiride
Intervention description: 20 mg, tablet; inactive tablet to match active comparator bexagliflozin; 2, 4 or 6 mg, capsule; inactive capsules to match active comparator glimepiride
Intervention MeSH terms: Glimepiride; Bexagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 426.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the effect of bexagliflozin compared to
      glimepiride as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in
      subjects with type 2 diabetes mellitus (T2DM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of T2DM

          -  Currently taking metformin or taking metformin and one additional oral medication for
             diabetes

          -  Body Mass Index (BMI) ≤ 45 kg/m2

          -  Stable dose of blood pressure or cholesterol medications (if applicable) for at least
             30 days

        Exclusion Criteria:

          -  Hypersensitivity or other contraindication to the safe use of sulfonylurea or
             glimepiride

          -  Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young

          -  Current use of injected therapy for treatment of diabetes (insulin or GLP-1 receptor
             agonist therapy) or thiazolidinedione class drugs

          -  History of genitourinary tract infections

          -  Evidence of abnormal liver function

          -  Myocardial infarction, stroke or hospitalization for heart failure within 3 months of
             screening

          -  Prior kidney transplant or evidence of kidney problems

          -  Pregnant or nursing
SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: (vic-)trastuzumab duocarmazine; Physician's choice
Intervention description: Intravenous SYD985, Q3W; See drug label
Intervention MeSH terms: Capecitabine; Trastuzumab; Vinorelbine; Lapatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 437.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is
      superior to physician's choice in prolonging progression free survival.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Female patients with histologically-confirmed, unresectable locally advanced or
             metastatic breast cancer;

          -  Patients should have had either progression during or after at least two
             HER2-targeting treatment regimens for locally advanced or metastatic disease or
             progression during or after (ado-)trastuzumab emtansine treatment for locally advanced
             or metastatic disease;

          -  HER2-positive tumor status;

          -  Patients must have measurable or non-measurable disease that is evaluable per RECIST
             1.1;

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;

          -  Estimated life expectancy > 12 weeks at randomization;

          -  Adequate organ function and blood cell counts.

        Main Exclusion Criteria:

          -  Current or previous use of a prohibited medication as listed in the protocol;

          -  History of infusion-related reactions and/or hypersensitivity to trastuzumab,
             (ado-)trastuzumab emtansine;

          -  History of keratitis;

          -  Severe, uncontrolled systemic disease at screening;

          -  Left Ventricular Ejection Fraction (LVEF) < 50%, or a history of clinically
             significant decrease in LVEF during previous treatment with trastuzumab or
             (ado-)trastuzumab emtansine;

          -  Cardiac troponin value above the Upper Limit of Normal (ULN);

          -  History of clinically significant cardiovascular disease;

          -  Untreated brain metastases, symptomatic brain metastases, brain metastases requiring
             steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to
             randomization;

          -  History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
             obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of
             active pneumonitis on screening chest CT scan.
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
Condition: Candida Vulvovaginitis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Vulvovaginitis
Intervention: Ibrexafungerp; Placebo
Intervention description: Ibrexafungerp 300 mg BID for 1 day; Matching placebo
Intervention MeSH terms: Ibrexafungerp
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, placebo-controlled, double-blind study
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 376.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a Phase 3, randomized, multicenter, double-blind, placebo-controlled study to
      evaluate the efficacy and safety of oral Ibrexafungerp (SCY-078) compared to placebo in
      female subjects 12 years and older with AVVC.
    

Eligibility criteria:

        Inclusion Criteria:

        Subject is a postmenarchal female subject 12 years and older

        Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic
        examination with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or
        budding yeasts, and vaginal pH (≤4.5)

        Exclusion Criteria:

        Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or
        evaluation of response to therapy, such as suspected or confirmed concurrent causes of
        vulvovaginitis and/or cervicitis (mixed infection)

        Need for systemic and/or topical (vaginal) antifungal treatment, including prescription or
        over-the-counter products during the study and treatment for VVC 28 days prior to
        randomization

        Subject is actively menstruating at the time of the Baseline visit.

        Subject has uncontrolled diabetes mellitus.

        Subject has a vaginal sample with pH >4.5.

        Subject has a history of or an active cervical/vaginal cancer.
Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Faster-acting insulin aspart; insulin aspart
Intervention description: Injected s.c. /subcutaneously (under the skin); Injected s.c. /subcutaneously (under the skin)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 472.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe and the United States of America (USA). The aim of this
      trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of
      Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age at least 18 years at the time of signing the informed consent

          -  Diagnosed with T1DM (Type 1 Diabetes Mellitus) (based on clinical judgement and/or
             supported by laboratory analysis as per local guidelines) equal or above 1 year prior
             to the day of screening

          -  Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754),
             Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a
             rapid acting insulin analogue for at least six months prior to screening and willing
             to stay on the same pump model throughout the trial (if the model is changed the
             change should not exceed 7 consecutive days.)

          -  HbA1c (glycosylated haemoglobin) 7.0-9.0% (53-75 mmol/mol) as assessed by central
             laboratory at screening

          -  Body mass index (BMI) below or equal to 35.0 kg/m^2 at screening

          -  Ability and willingness to take at least 3 daily meal-time insulin bolus infusions
             every day throughout the trial

        Exclusion Criteria:

          -  Any of the following: myocardial infarction, stroke, hospitalization for unstable
             angina or transient ischaemic attack within the past 180 days prior to the day of
             screening

          -  Planned coronary, carotid or peripheral artery revascularisation known on the day of
             screening

          -  History of hospitalization for ketoacidosis below or equal to 180 days prior to the
             day of screening

          -  Treatment with any medication for the indication of diabetes or obesity other than
             stated in the inclusion criteria in a period of 90 days before screening

          -  Any condition which, in the opinion of the Investigator, might jeopardise a Subject's
             safety or compliance with the protocol