bioihbjkbjnl/mcl2 huggingface dataset:
Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: onabotulinumtoxinA; normal saline
Intervention description: OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Or, if placebo is administered at Day 1, onabotulinumtoxinA 100 U injected after a minimum of 12 weeks (if applicable).; Normal saline (placebo) injected into the detrusor at Day 1.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 548.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A
      (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary
      incontinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptoms of OAB (frequency/urgency) with urinary incontinence for at least 6 months

          -  Inadequate response or limiting side effects with anticholinergics for the treatment
             of OAB

        Exclusion Criteria:

          -  Overactive Bladder caused by neurological condition

          -  Patient has predominance of stress incontinence

          -  History or evidence of pelvic or urological abnormality
Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Comparator: montelukast; Comparator: loratadine; Comparator: placebo; Comparator: montelukast/loratadine
Intervention description: 10 mg montelukast tablet given once daily at bedtime for 2 weeks; 10 mg loratadine tablet given once daily at bedtime for 2 weeks; placebo tablet given once daily at bedtime for 2 weeks; montelukast 10-mg/loratadine 10-mg combination tablet taken orally once daily at bedtime for 2 weeks
Intervention MeSH terms: Loratadine; Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1577.0
Sex: All
Minimum age: 15 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a documented history of seasonal allergic rhinitis symptoms that flare up
             during the study season

          -  Patient is a nonsmoker and has been a nonsmoker for at least 1 year

          -  Patient is in good general health

        Exclusion Criteria:

          -  Patient is hospitalized

          -  Patient is a woman who is less than 8 weeks postpartum or is breast-feeding

          -  Patient intends to move or vacation away during the study

          -  Patient has had any major surgery within 4 weeks of study start

          -  Patient is a current or past abuser of alcohol or illicit drugs

          -  Patient has been treated in an emergency room for asthma in the past month

          -  Patient had an upper respiratory infection with in 3 weeks prior to study start
Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment
Condition: Ulcer
Intervention: Ibuprofen/famotidine; Ibuprofen
Intervention description: HZT-501: Ibuprofen800mg/famotidine 26.6mg administered orally 3 times daily for 24 weeks; Ibuprofen 800mg administered orally 3 times daily for 24 weeks
Intervention MeSH terms: Ibuprofen; Famotidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 906.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: ibuprofen; famotidine; ulcers; NSAIDS; pain; arthritis; chronic regional pain syndrome; chronic soft tissue pain; osteoarthritis; rheumatoid arthritis; chronic low back pain

Summary:

      The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of
      development of ibuprofen-associated ulcers in patients who require long-term daily use of
      ibuprofen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Expected to require daily administration of an NSAID for at least the coming six
             months for conditions such as osteoarthritis, rheumatoid arthritis, chronic low back
             pain, chronic regional pain syndrome, and chronic soft tissue pain.

          -  Did not use a NSAID within the 30 days prior to study entry

        Exclusion Criteria:

          -  History of erosive esophagitis

          -  History of any of the following serious gastrointestinal complications:

               -  perforation of ulcers,

               -  gastric outlet obstruction due to ulcers, or

               -  gastrointestinal bleeding.

          -  Active cardiac, renal, and/or hepatic disease

          -  Current Helicobacter pylori (H. pylori) infection

          -  Use of an acid suppressant agent, misoprostol, or more than 325 mg/day of aspirin
             within the 14 days prior to study entry.

          -  Uncontrolled diabetes

          -  Uncontrolled hypertension

          -  Positive pregnancy test at screening

          -  Positive test at Screening for human immunodeficiency virus (HIV), hepatitis B, or
             hepatitis C.

          -  Currently participating, or participation within 30 days prior to study entry, in an
             investigational drug study

        Please note that there are other additional criteria. The study center will determine if
        patients meet all of the criteria.
Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures
Condition: Epilepsy; Partial-onset Seizures
MeSH terms: Epilepsy; Seizures
Intervention: Lacosamide
Intervention description: Strength: Lacosamide (LCM) 50 mg, LCM 100 mg
Formulation: Tablet
Frequency: twice daily during the study period (until the date of approval)
At the completion of EP0008 [NCT01710657], all subjects who choose to enroll in EP0009 will be taking a dose of Lacosamide 200 mg/day. At the beginning of EP0009, the investigator may maintain the LCM dose or increase or decrease the dose. During the Treatment Period, the investigator will be allowed to increase or decrease the dose of LCM to optimize tolerability and seizure reduction. The LCM dose may be decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day.
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 473.0
Sex: All
Minimum age: 16 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Lacosamide; Epilepsy; Partial-onset Seizures

Summary:

      The purpose of this trial is to evaluate the safety and tolerability of long-term
      administration of Lacosamide at doses up to 400 mg/day in Japanese and Chinese adults with
      Epilepsy who have completed the Treatment and Transition Period of EP0008 [NCT01710657]
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has completed the Treatment and Transition Period of EP0008 [NCT01710657]

        Exclusion Criteria:

          -  Subjects who withdrew from EP0008 [NCT01710657]
Efficacy and Tolerability of Human FSH Versus Recombinant FSH (Follitropin Alpha) in ICSI.
Condition: Infertility
MeSH terms: Infertility
Intervention: Follicle Stimulating Hormone; Follicle Stimulating Hormone
Intervention description: subcutaneous injection of FSH. Starting dose: 225 IU.; subcutaneous injection of FSH. Starting dose: 225 IU.
Intervention MeSH terms: Hormones; Follicle Stimulating Hormone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Enrollment: 151.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Ovarian stimulation; Infertility; ICSI; FSH

Summary:

      Purpose of the study is the comparative evaluation of the clinical efficacy and of the
      general tolerability of two different subcutaneous FSH preparations (Fostimon® IBSA Vs
      Gonal-F® Serono) when administered in patients undergoing ICSI
    

Eligibility criteria:

        Inclusion Criteria:

        Women undergoing ovarian stimulation for IntraCytoplasmic Sperm Injection (ICSI) with the
        following characteristics:

        >/= 18 and < 40 years old BMI between 19 and 30 kg/m2 less than 3 previous completed cycles
        basal FSH level less than 10 IU/l within the 6 months prior to the study

        Exclusion Criteria:

        age < 18 and >/= 40 years primary ovarian failure or women known as poor responders, i.e.
        requiring more than 225 IU of FSH as starting dose in previous treatment cycles or having
        less than 3 oocytes retrieved or with an oestradiol serum concentration < 900 pmol/l (250
        pg/ml) ovarian cysts > 20 mm oocyte donation thawed embryos replacement patients affected
        by pathologies associated with any contraindication of being pregnant ascertained or
        presumptive hypersensitivity to the active principle and/or their ingredients abnormal
        bleeding of undetermined origin uncontrolled thyroid or adrenal dysfunction neoplasias
        severe impairment of the renal and/or hepatic functions women deprived of their freedom by
        administrative or legal decision
A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Intervention: Ticagrelor; Clopidogrel
Intervention description: Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets; Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets
Intervention MeSH terms: Clopidogrel; Ticagrelor
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13885.0
Sex: All
Minimum age: 50 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Peripheral artery disease Atherothrombotic events Atherosclerosis

Summary:

      The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients
      with Peripheral Artery Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and Female patients 50 years old or older Symptomatic peripheral artery disease

        Exclusion Criteria:

          -  Patients needing dual anti-platlet drug treatment before start of study Planned
             revascularisation or amputation

          -  Patients with known bleeding disorders

          -  Patients with a history of intracranial bleed

          -  Patients considered to be at risk of bradycardic events unless already treated with a
             permanent pacemaker
Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) 300mg in Chinese Subjects With Chronic Hepatitis B (CHB)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Tenofovir disoproxil fumarate (TDF) tablets; Adefovir dipivoxil (ADV) tablets
Intervention description: white, almond-shaped, film-coated tablets containing 300mg of TDF; white to off-white, round, biconvex tablets containing 10mg of ADV
Intervention MeSH terms: Tenofovir; Adefovir; Adefovir dipivoxil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 512.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: tenofovir disoproxil fumarate; chronic hepatitis B; adefovir dipivoxil

Summary:

      This is a multi-centre, double blind, double dummy, randomised, controlled study to evaluate
      the efficacy and safety of TDF 300mg QD versus ADV 10mg QD in Chinese subjects with CHB. This
      study is designed to demonstrate the superiority of TDF 300mg QD over ADV 10mg QD in treating
      Chinese subjects with CHB (hepatitis B e antigen [HBeAg] positive subjects and HBeAg negative
      subjects). It will also provide long-term efficacy and safety data (up to 240 weeks) for TDF
      300 mg administered once daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HBeAg positive/negative CHB with blood HBVDNA≥10^5 copies/mL and elevated ALT

          -  Nucleoside and nucleotide naïve CHB subjects. Previous lamivudine treatment is allowed
             in less than 10% of the total study population

        Exclusion Criteria:

          -  subjects with hepatocellular carcinoma (HCC) potential or decompensated liver disease

          -  subjects with acute liver disease due to other causes

          -  subjects with medication history of immunosuppressive therapy, immunomodulatory
             therapy, systemic cytotoxic agents, chronic antiviral agents including Chinese herbal
             medicines known to have activity against HBV (e.g., lamivudine, hepatitis B
             immunoglobulin (HBIg)) within the previous 6 months prior to randomisation into this
             study
Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Megestrol acetate; exemestane (Aromasin)
Intervention description: Megestrol Acetate 160 mg oral tablets Qd; exemestane (Aromasin) 25 mg oral tablets Qd
Intervention MeSH terms: Exemestane; Megestrol; Megestrol Acetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: Female
Healthy volunteers: No
Keywords: Metastatic Breast Cancer; Advanced; Postmenopausal; Exemestane vs Megestrol

Summary:

      Long term efficacy of exemestane as compared to megestrol acetate in the treatment of women
      with natural or induced postmenopausal status with advanced breast cancer whose disease has
      progressed following anti-estrogens or anti-estrogens plus chemotherapy and who had
      participated on an original study of exemestane vs megestrol : study 971-ONC-0028-080.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous participation in study 971-ONC-0028-080.

        Exclusion Criteria:

          -  Subjects who had not previously participated in study 971-ONC-0028-080.
CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: CSL312; Placebo
Intervention description: Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody; Buffer without active ingredient
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to
      investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in
      the prophylactic treatment of hereditary angioedema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 12 years of age; diagnosed with clinically confirmed C1-INH
             hereditary angioedema; experience ≥ 3 attacks during the 3 months before screening.

        Note: For subjects taking any prophylactic HAE therapy during the 3 months before
        Screening, ≥ 3 HAE attacks may be documented over 3 consecutive months before commencing
        the prophylactic therapy.

        Exclusion Criteria:

          -  Concomitant diagnosis of another form of angioedema such as idiopathic or acquired
             angioedema, recurrent angioedema associated with urticarial or hereditary angioedema
             type 3
Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)
Condition: Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Mood Disorders
Intervention: OPC-34712 + ADT; Placebo + ADT; Placebo + ADT
Intervention description: Tablets, Oral, 1 or 3 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT); Placebo + FDA Approved Antidepressant (ADT); Placebo + FDA Approved Antidepressant (ADT)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1539.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: OPC-34712; brexpiprazole; Major Depressive Disorder; Adjunctive Treatment

Summary:

      To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive
      substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in
      patients with Major Depressive Disorder who demonstrate an incomplete response to a
      prospective trial of the same assigned FDA approved ADT
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between 18 and 65 years of age, with diagnosis of major
             depressive disorder, as defined by DSM-IV-TR criteria

          -  The current depressive episode must be equal to or greater than 8 weeks in duration

          -  Subjects must report a history for the current depressive episode of an inadequate
             response to no more than three adequate antidepressant treatments

        Exclusion Criteria:

          -  Females who are breast-feeding and/or who have a positive pregnancy test result prior
             to receiving study drug

          -  Subjects who report an inadequate response to more than three adequate trials of
             antidepressant treatments during current depressive episode at a therapeutic dose for
             an adequate duration

          -  Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia, amnestic
             or other cognitive disorder, Schizophrenia, schizoaffective disorder, or other
             psychotic disorder, Bipolar I or II disorder

          -  Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of
             borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality
             disorder
Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Intervention: Atogepant 30 mg; Atogepant 60 mg; Placebo
Intervention description: Tablets containing 30 mg atogepant; Tablets containing 60 mg atogepant; 30 mg/60 mg tablets containing atogepant-matching placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 778.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study evaluated the efficacy, safety and tolerability of atogepant in participants with
      chronic migraine. This study included a 12-week treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least a 1-year history of chronic migraine (CM) consistent with a diagnosis
             according to the International Classification of Headache Disorders, 3rd Edition
             (ICHD-3), 2018

          -  Age of the participant at the time of migraine onset < 50 years

          -  Confirmation of headache/migraine headache day frequency as follows:

               -  History of, on average, ≥ 15 headache days per month in the 3 months prior to
                  Visit 1 in the opinion of the investigator AND

               -  >=15 headache days during the 4-week screening/baseline period per the electronic
                  diary (eDiary) AND

               -  >=8 days during the 4-week screening/baseline period that qualify as being a
                  migraine day per the eDiary

          -  Participants must be using a medically acceptable and effective method of birth
             control during the course of the entire study

        Exclusion Criteria:

          -  Has a history of migraine, accompanied by diplopia or decreased level of
             consciousness, or retinal migraine

          -  Has a current diagnosis of new persistent daily headache, trigeminal autonomic
             cephalgia (eg, cluster headache), or painful cranial neuropathy

          -  History of an inadequate response to > 4 medications (2 of which have different
             mechanisms of action) prescribed for the prevention of migraine

          -  Woman is pregnant, planning to become pregnant during the course of the study, or
             currently lactating. Women of childbearing potential must have a negative urine
             pregnancy test at Visit 1 and Visit 2.