bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Placebo; Vilazodone; Vilazodone
Intervention description: Matching 10 mg and 20 mg placebo tablets, once per day, oral administration,; Vilazodone, 20mg, oral administration once per day.; Vilazodone, 40mg, oral administration once per day.
Intervention MeSH terms: Vilazodone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 680.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Generalized Anxiety Disorder; GAD

Summary:

      The purpose of this study is to evaluate the efficacy, safety and tolerability of vilazodone
      relative to placebo in the treatment of generalized anxiety disorder (GAD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female, 18 - 70 years of age

          -  Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder (GAD)

          -  Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)

        Exclusion Criteria:

          -  Women who are pregnant, women who will be breastfeeding during the study and women of
             childbearing potential who are not practicing a reliable method of birth control

          -  History of meeting DSM-IV-TR criteria for any of the following:

               -  Any manic or hypomanic or mixed episode, including bipolar disorder and
                  substance-induced manic, hypomanic or mixed episode

               -  Any depressive episode with psychotic or catatonic features

               -  Panic disorder with or without agoraphobia

               -  Obsessive-compulsive disorder

               -  Schizophrenia, schizoaffective, or other psychotic disorder

               -  Bulimia or anorexia nervosa

               -  Presence of borderline personality disorder or antisocial personality disorder

               -  Mental retardation, dementia, amnesia, or other significant cognitive disorders

          -  Patients who are considered a suicide risk
CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004
Condition: Dry Eye Disease (DED)
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: CyclASol Ophthalmic Solution
Intervention description: Cyclosporine A solution in vehicle
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 202.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this trial is to evaluate safety and tolerability of CyclASol during
      long-term use in subjects with Dry Eye Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed the clinical trial CYS-004 and habe been compliant with trial
             procedures

          -  Signed ICF (Informed Consent Form)

          -  Subject-reported history of DED in both eyes

          -  Ability and willingness to follow instructions, including participation in all study
             assessments and visits

        Exclusion Criteria:

          -  Early termination of CYS-004

          -  Clinically significant slit-lamp findings or ocular conditions that require
             prescriptive medical treatment and/or in the opinion of the investigator may interfere
             with trial parameters

          -  Have a history of herpetic keratitis;

          -  Have an ocular or periocular malignancy;

          -  Be unwilling to avoid wearing contact lenses during the trial;

          -  Have any planned ocular or eyelid surgeries during the trial period

          -  Be a woman who is pregnant, nursing or planning a pregnancy

          -  Unwillingness to submit a urine pregnancy test at all onsite visits if of childbearing
             potential

          -  Women of childbearing potential not using an acceptable means of contraception

          -  Presence of known allergy and/or sensitivity to the study drug or its components

          -  Be currently using an investigational drug or device or have used an investigational
             drug or device within 60 days before Visit 1 other than for CYS-004

          -  Have a condition or be in a situation (eg language barrier) which the investigator
             feels may put the subject at significant risk,may confound the trial results, or may
             interfere with the subject's participation in the trial significantly
Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery
Condition: Cataract
MeSH terms: Cataract; Inflammation
Intervention: Dexamethasone; Prednisolone
Intervention description: depot intracameral; Prednisolone eye drops 1%
Intervention MeSH terms: Dexamethasone; Prednisolone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 194.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40
      years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion
      criteria will be randomized to 1 of 2 treatment groups

        -  A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone,
           equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;

        -  Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times
           daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp
           biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and
           specular microscopy endothelial cell count.
    

Eligibility criteria:

        Inclusion Criteria:

          -  undergoing cataract surgery

        Exclusion Criteria:

          -  glaucoma patient, pregnancy, allergy to dexamethasone
A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants
Condition: Neoplasms
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: Rivaroxaban; Placebo
Intervention description: Rivaroxaban 10 milligram (mg) tablet will be administered orally once daily for 180 days.; Placebo tablet will be administered orally once daily for 180 days.
Intervention MeSH terms: Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 841.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Rivaroxaban; Venous thromboembolism

Summary:

      The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for
      reducing the risk of the primary composite outcome as defined by objectively confirmed
      symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity
      proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT,
      symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism
      (VTE)-related death in ambulatory adult participants with various cancer types receiving
      systemic cancer therapy who are at high risk of developing a VTE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histologically confirmed solid malignancy including but not limited to: pancreas,
             lung, stomach, colon, rectum, bladder, breast, ovary, renal or lymphoma (hematologic),
             with locally advanced or metastatic disease

          -  Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

          -  Have a Khorana thromboembolic risk Score greater than or equal to (>=) 2

          -  Creatinine clearance (CrCl) >= 30 milliliter per minute (mL/min)

          -  Plan to initiate systemic cancer therapy within plus or minus (+-) 1 week of receiving
             the first dose of study drug with the intention of receiving systemic cancer therapy
             during the double-blind treatment period for an intended duration determined by the
             treating oncologist according to standard protocols of clinical care

        Exclusion Criteria:

          -  Diagnosis of primary brain tumors

          -  Known history of brain metastases

          -  Bleeding diathesis, hemorrhagic lesions, active bleeding, and other conditions with a
             high risk for bleeding

          -  Hematologic malignancies with the exception of lymphoma

          -  Platelet count less than (<) 50,000/millimeter^3 (mm^3), Life expectancy of less than
             or equal to (<=) 6 months
Patient Narcotic Requirements After Outpatient Otolaryngology Procedures
Condition: Outpatient Surgery; Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Norco; Ibuprofen
Intervention description: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control; Ibuprofen as first line therapy every 6 hours as needed for pain control
Intervention MeSH terms: Acetaminophen; Ibuprofen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Narcotics
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized to one of two groups prior to surgery. All patients will be prescribed both Hydrocodone/acetaminophen and Ibuprofen. Group 1 will take the narcotic medication for initial pain control followed by Ibuprofen if pain is not adequately controlled. Group 2 will take Ibuprofen for initial pain control followed by the narcotic medication if pain is not adequately controlled.
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Thyroidectomy; Parotidectomy; Tympanoplasty; Mastoidectomy; Septoplasty; Sinus Surgery; Postoperative pain; Outpatient surgery

Summary:

      Patient's pain level and narcotic requirements will be evaluated after routine outpatient
      Otolaryngology procedures. This will be done by having study participants record their pain
      level and medication usage from home.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients undergoing one of the following outpatient procedure:

          -  Septoplasty

          -  Unilateral or Bilateral Functional endoscopic sinus surgery

          -  Tympanomastoidectomy

          -  Tympanoplasty

          -  Total or Partial Thyroidectomy

          -  Parathyroidectomy

          -  Parotidectomy.

          -  Age >18 years and < 89 years

        Exclusion Criteria:

          -  Age < 18 years or > 89 years

          -  Post operative hospital admission

          -  Allergy to Hydrocodone

          -  Allergy or contraindication to Ibuprofen or NSAIDs

          -  Pregnancy

          -  Hepatic disease

          -  Chronic kidney disease

          -  Sickle cell anemia
Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Eisenmenger Complex
Intervention: Macitentan 10 mg tablet, once daily.
Intervention description: Macitentan 10 mg tablet, once daily.
Intervention MeSH terms: Macitentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 217.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Eisenmenger Syndrome; exercise capacity

Summary:

      Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used
      for treatment of Eisenmenger syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects with ES (including those with Down Syndrome) having completed the double-blind
        AC-055-305 / MAESTRO study as scheduled, i.e., who remained in the double-blind study up to
        Week 16 (whether or not they were still taking study drug at the end of this period).

        Exclusion Criteria:

        Subjects who prematurely discontinue double-blind study drug during the AC-055-305 /
        MAESTRO study due to:

          -  an AE assessed as related to the use of study drug,

          -  or elevated liver tests (related or unrelated to study drug).
Extension Study of Maintenance Treatment With Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Condition: Chronic Inflammatory Demyelinating Polyneuropathy (CIDP); Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
MeSH terms: Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Polyradiculoneuropathy
Intervention: IgPro20
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is an extension study to the pivotal study IgPro20_3003 (NCT01545076). The purpose
      of this extension study is to investigate the long-term treatment of CIDP with IgPro20, with
      regard to safety and efficacy.

      Subjects who have completed subcutaneous (SC) Week 25 or were successfully rescued from a
      CIDP relapse during the SC Treatment Period of pivotal study IgPro20_3003 (NCT01545076) will
      have the option to receive open-label low-dose IgPro20 (0.2 g/kg bodyweight [bw]) weekly for
      up to 48 weeks. Subjects relapsing on low-dose IgPro20 will either return to high-dose
      IgPro20 (0.4 g/kg) immediately or be discontinued, depending on investigator's judgment.
      Subjects returning to high-dose IgPro20 will continue on high-dose until they have completed
      a total of 48 weeks of IgPro20 treatment. If subjects do not successfully recover from CIDP
      relapse within 4 weeks, they will be withdrawn.

      The treatment duration will be up to 48 weeks, followed by a completion visit (week 49).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects having completed the pivotal study IgPro20_3003 (SC Week 25) or successfully
             rescued from a CIDP relapse during the SC Treatment Period of pivotal study
             IgPro20_3003 (NCT01545076).

          -  Written informed consent for study participation obtained before undergoing any
             study-specific procedures.

        Exclusion Criteria:

          -  Subject is unable to directly transition from study IgPro20_3003.

          -  New medical condition and/or social behavior (ie, alcohol, drug, or medication abuse)
             during participation in study IgPro20_3003 that in the judgment of the investigator
             could increase risk to the subject, interfere with the evaluation of investigational
             medicinal product, and/or conduct of the study.
Paradoxical Stimulation of Hepatic Glucose Production With Dapagliflozin
Condition: Type II; Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Placebo
Intervention description: Three 5-hour measurements (after dapagliflozin 10mg administration) of endogenous glucose production (EGP) will be performed on separate days.; Three 5-hour measurements (after placebo administration) of endogenous glucose production (EGP) will be performed on separate days.
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      To determine the role of plasma glucagon and insulin in the rise of endogenous glucose
      production (EGP) following the SGLT2 inhibition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  T2DM according to ADA criteria-HbA1C < 8.0%

          -  BMI = 25-35 kg/m2

          -  Subjects must be in good general health as determined by physical exam, medical
             history, blood chemistries, CBC, TSH, T4, EKG and urinanalysis

          -  Body weight has been stable (± 3 lbs) over the preceding three months

          -  Do not participate in an excessively heavy exercise program

          -  Taking stable dose (more than 3 months) of monotherapy or combination therapy with
             metformin and/or a sulfonylurea

        Exclusion Criteria:

          -  Subjects taking drugs known to affect glucose metabolism (other than metformin and
             sulfonylurea) will be excluded

          -  Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine
             >1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg will be
             excluded
Evaluation of the Efficacy and Safety of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease
Condition: Dry Eye Disease (DED)
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Intervention: OC-01 (varenicline) nasal spray; Placebo (vehicle) nasal spray
Intervention description: OC-01 (varenicline) nasal spray; Placebo (vehicle) nasal spray
Intervention MeSH terms: Varenicline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 758.0
Sex: All
Minimum age: 22 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and effectiveness of OC-01 Nasal Spray
      as compared to placebo on signs and symptoms of dry eye disease.
    

Eligibility criteria:

        Inclusion Criteria:

        - Have used and/or desired to use an artificial tear substitute for dry eye symptoms within
        6 months prior to Visit 1

        Exclusion Criteria:

          -  Have had any intraocular surgery (such as cataract surgery) or extraocular surgery in
             either eye within three months or refractive surgery (e.g. laser-assisted in-situ
             keratomileusis, laser epithelial keratomileusis, photorefractive keratectomy or
             corneal implant) within twelve months of Visit 1.

          -  Have a history or presence of any ocular disorder or condition in either eye that
             would, in the opinion of the Investigator, likely interfere with the interpretation of
             the study results or participant safety such as significant corneal or conjunctival
             scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis,
             or inflammation not associated with dry eye; anterior (epithelial) basement membrane
             corneal dystrophy or other clinically significant corneal dystrophy or degeneration;
             ocular herpetic infection; evidence of keratoconus; etc. Blepharitis not requiring
             treatment and mild meibomian gland disease that are typically associated with dry eye
             disease are allowed.

          -  Have a systemic condition or disease not stabilized or judged by the Investigator to
             be incompatible with participation in the study or with the lengthier assessments
             required by the study (e.g., current systemic infection, uncontrolled autoimmune
             disease, uncontrolled immunodeficiency disease, history of myocardial infarction or
             heart disease, etc.)

          -  Have a known hypersensitivity to any of the procedural agents or study drug components

          -  Have any condition or history that, in the opinion of the investigator, may interfere
             with study compliance, outcome measures, safety parameters, and/or the general medical
             condition of the subject.
Dosing Validation Study of Oral Testosterone Undecanoate (TU, LPCN 1021).
Condition: Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Intervention: LPCN 1021
Intervention description: Oral testosterone undecanoate
Intervention MeSH terms: Methyltestosterone; Testosterone 17 beta-cypionate; Testosterone; Testosterone undecanoate; Testosterone enanthate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: Male
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Multicenter, open-label, one treatment study evaluating the efficacy of LPCN 1021 in adult
      hypogonadal male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Serum total T below 300 ng/dL based on 2 consecutive blood samples obtained between 6
             and 10 AM, on two separate days at approximately the same time of day, following an
             appropriate washout of current androgen replacement therapy.

          2. Subjects should be diagnosed to be primary (congenital or acquired) or secondary
             hypogonadal (congenital or acquired).

          3. Naïve to androgen replacement or has discontinued current treatment and completed
             adequate washout of prior androgen therapy. Washout must be completed prior to
             collection of baseline serum T samples to determine study eligibility.

        Exclusion Criteria:

          1. History of significant sensitivity or allergy to androgens, or product excipients.

          2. Clinically significant findings in the pre-study examinations including abnormal
             breast examination requiring follow-up.

          3. Abnormal prostate digital rectal examination (DRE) with palpable nodule(s).

          4. Subjects with symptoms of moderate to severe benign prostatic hyperplasia.

          5. Clinically significant abnormal laboratory value, in the opinion of the investigator,
             in serum chemistry, hematology, or urinalysis

          6. Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B
             surface antigen (HBsAg) or hepatitis C virus antibody (HCV Ab) or human
             immunodeficiency virus antibodies (HIV Ab).

          7. History of gastric surgery, cholecystectomy, vagotomy, bowel resection or any surgical
             procedure that might interfere with gastrointestinal motility, pH or absorption.

          8. History of any clinically significant illness, infection, or surgical procedure within
             1 month prior to study drug administration.

          9. History of stroke or myocardial infarction within the past 5 years.

         10. History of or current or suspected prostate or breast cancer.

         11. History of untreated and severe obstructive sleep apnea.

         12. History of long QT syndrome (QTc > 450) or unexplained sudden death in a first degree
             relative (parent, sibling, or child).