bioihbjkbjnl/mcl2 huggingface dataset:
An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms
Condition: Erectile Dysfunction; Lower Urinary Tract Symptoms
MeSH terms: Erectile Dysfunction; Lower Urinary Tract Symptoms
Intervention: Placebo; Alfuzosin
Intervention description: Alfuzosin-matched One tablet once daily; 10 mg once daily
Intervention MeSH terms: Alfuzosin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 74.0
Sex: Male
Minimum age: 30 Years
Maximum age: 69 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the effect of Alfuzosin in treating Erectile
      Dysfunction in men with mild lower urinary tract symptoms based upon a change from baseline
      in erectile function (EF) domain of International Index of Erectile Function (IIEF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male, 30-69 years of age

          -  Has mild to moderate Erectile Dysfunction with a score < 25 on EF domain in IIEF

          -  AUA score of less than or equal to 14

          -  Negative urinalysis with no evidence of a Urinary Tract Infection

        Exclusion Criteria:

          -  Blood pressure < 90/50 or > 170/110

          -  Neurological disorder (MS, SCI, CVA, Parkinson's disease, ALS)

          -  Diabetes Mellitus

          -  History of PSA > 10

          -  History of confirmed or suspected prostate cancer

          -  History of Moderate/Severe Hepatic Insufficiency defined as > 2X ULN

          -  On Alpha Blocker or PDE 5 inhibitor within 2 weeks of randomization

          -  Receive treatment with other investigational agents within 30 days prior to enrollment
A Trial Evaluating the Efficacy and Safety of the Sublingual Sufentanil Tablet 30 mcg for Post-Operative Pain After Abdominal Surgery
Condition: Post-Operative Pain
MeSH terms: Pain, Postoperative
Intervention: Sufentanil Tablet 30 mcg; Placebo Tablet
Intervention MeSH terms: Sufentanil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the efficacy and safety of the sublingual Sufentanil
      Tablet (ST) 30 mcg to the sublingual Placebo Tablet (PT) for the short-term management of
      moderate-to-severe acute post-operative pain in patients after abdominal surgery.
    

Eligibility criteria:

        Inclusion Criteria (additional criteria not specified here):

          1. Patients who are scheduled to undergo one of the following procedures with general
             anesthesia or spinal anesthesia that does not include intrathecal opioids during the
             operation:

               -  abdominoplasty

               -  open tension-free inguinal hernioplasty (Lichenstein repair with mesh)

               -  laparoscopic abdominal surgery

          2. Patients classified as American Society of Anesthesiologists (ASA) class I - III
             (Appendix I).

          3. Female patients of childbearing potential must be using an effective method of birth
             control at the time of screening visit

          4. Patients who are expected to have moderate-to-severe post-operative pain for at least
             24 hours.

        Exclusion Criteria (additional criteria not specified here):

          1. Patients who have taken an opioid for more than 30 consecutive days, at a daily dose
             of more than 15 mg of morphine (or equivalent), within the past 3 months prior to
             surgery

          2. Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken
             MAOIs within 14 days of the first dose of study drug.

          3. Patients with current sleep apnea that has been documented by a sleep laboratory study
             or are on home continuous positive airway pressure (CPAP).

          4. Patients who previously have had abdominoplasty or have had an inguinal hernia repair
             on the same side.
The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin 100 mg; Canagliflozin 300 mg; Metformin; Sulphonylurea
Intervention description: One 100 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea; One 300 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea; Patients will continue to take background therapy with Metformin for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.; Patients will continue to take background therapy with Sulphonylurea for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Canagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 756.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Canagliflozin; Sitagliptin (Januvia); Metformin; Sulphonylurea; Hemoglobin A1c; Type 2 diabetes mellitus

Summary:

      The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared
      with sitagliptin in patients with type 2 diabetes mellitus who are receiving treatment with
      metformin and sulphonylurea and have inadequate glycemic (blood sugar) control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have a diagnosis of T2DM and be currently treated with metformin and
             sulphonylurea

          -  Patients in the study must have a HbA1c between >=7 and <=10.5% and a fasting plasma
             glucose (FPG) <300 mg/dL (16.7 mmol/L)

        Exclusion Criteria:

          -  History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta
             cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy

          -  or a severe hypoglycemic episode within 6 months before screening
A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
Condition: Colorectal Cancer
MeSH terms: Colonic Neoplasms
Intervention: 5-Fluorouracil; Leucovorin; Capecitabine [Xeloda]
Intervention description: 425mg/m2 iv daily from day 1 to day 5 every 28 days.; 20mg/m2 iv daily from day 1 to day 5 every 28 days.; 1250mg/m2 po bid on days 1-14 every 21 days.
Intervention MeSH terms: Leucovorin; Capecitabine; Fluorouracil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1987.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in
      combination with leucovorin, in patients who have undergone surgery for colon cancer.
      Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21
      days, or leucovorin 20mg/m2 iv + 5-fluorouracil 425mg/m2 iv daily from day 1 to day 5 every
      28 days. The anticipated time on study treatment is 3-12 months, and the target sample size
      is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients 18-75 years of age;

          -  histologically confirmed colon cancer with potentially curative resection of the tumor
             within 8 weeks before study initiation.

        Exclusion Criteria:

          -  previous chemotherapy
Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism
Condition: Venous Thrombosis
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Venous Thrombosis
Intervention: Apixaban; Placebo
Intervention description: Tablets, Oral, twice daily, 12 months; Tablets, Oral, twice daily, 12 months
Intervention MeSH terms: Apixaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2711.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in
      preventing venous thromboembolic (VTE) recurrence or death in patients who have completed
      their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age;

          -  Clinical diagnosis of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE);

          -  Anticoagulant treatment completed

          -  No recurrence of Venous Thromboembolism (VTE)

        Exclusion Criteria:

          -  Subjects with indications for long-term treatment with a vitamin K antagonist

          -  Active bleeding or high risk for serious bleeding

          -  Short life expectancy

          -  Uncontrolled high blood pressure

          -  Impaired kidney or liver function
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Intervention: Bromfenac; Placebo
Intervention description: sterile ophthalmic solution; sterile ophthalmic solution
Intervention MeSH terms: Bromfenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cataract extraction; intraocular lens implantation

Summary:

      Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled for cataract surgery

        Exclusion Criteria:

          -  Known hypersensitivity to bromfenac and salicylates
A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dulaglutide; Insulin glargine; Metformin; Sulfonylureas
Intervention description: Administered SC; Administered SC per dosing titration schedule; Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.; Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
Intervention MeSH terms: Metformin; Insulin Glargine; Dulaglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 774.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe
      compared to once-daily insulin glargine in participants with type 2 diabetes mellitus who
      have inadequate glycemic control with 1 or 2 oral antihyperglycemic medications (OAM)
      (metformin and/or a sulfonylurea), in addition to any healthy lifestyle changes recommended
      by their healthcare providers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have type 2 diabetes mellitus for at least 6 months

          -  Have been taking metformin and/or a sulfonylurea for at least 3 months before
             screening and have been on a stable therapeutic dose for at least 8 weeks

          -  Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤11.0%

          -  Adult men or adult non-pregnant, non-breastfeeding women

          -  Body Mass Index (BMI) of ≥19.0 to ≤35.0 kilograms/square meter (kg/m^2)

          -  Stable weight (±5%) ≥3 months prior to screening

        Exclusion Criteria:

          -  Have type 1 diabetes mellitus

          -  Have previous treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1
             analog, or any other incretin mimetic

          -  Have treatment with dipeptidyl peptidase-IV (DPP-IV) inhibitor, an alpha-glucosidase
             inhibitor (AGI), thiazolidinedione (TZD), or glinide

          -  Have gastric emptying abnormality

          -  Have cardiac disorder defined as unstable angina, myocardial infarction, coronary
             artery bypass graft surgery, percutaneous coronary intervention, heart failure,
             arrhythmia, transient ischemic attack, or stroke

          -  Have poorly controlled hypertension (systolic blood pressure above 160 millimeter of
             mercury[mmHg] or diastolic blood pressure above 95 mmHg)

          -  Have impaired liver function

          -  Have impaired kidney function

          -  Have history of chronic pancreatitis or acute pancreatitis

          -  Have a serum calcitonin ≥20 picograms per milliliter (pg/mL)

          -  Have a personal or family history of medullary C-cell hyperplasia, focal hyperplasia,
             carcinoma, or multiple endocrine neoplasia type 2 (MEN 2)
Efficacy and Safety Study of Symbicort® Turbuhaler® Versus Oxis® Turbuhaler® in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Budesonide/formoterol (Symbicort Turbuhaler); Formoterol (Oxis Turbuhaler)
Intervention description: 2x160/4.5 microgram, inhalation, twice daily, 12 weeks; 2 X 4.5 microgram, inhalation, twice daily, 12 weeks
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1293.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Symbicort; Oxis; Chronic Obstructive Pulmonary Disease; COPD; Efficacy

Summary:

      The primary purpose of the study is to investigate if Symbicort is more effective than Oxis
      in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in
      patients with COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A current clinical diagnosis of Chronic Obstructive Pulmonary Disease

          -  Documented Chronic Obstructive Pulmonary Disease symptoms for more than 2 years

          -  A smoking history of at least 10 pack years

        Exclusion Criteria:

          -  History and/or current clinical diagnosis of asthma

          -  History and/or current clinical diagnosis of atopic diseases such as allergic rhinitis
The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Memantine; Placebo pill
Intervention description: 10mg Memantine; 10mg placebo pill
Intervention MeSH terms: Memantine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 50 Years
Maximum age: 95 Years
Healthy volunteers: No

Summary:

      The aim of the proposed study is to determine if the NMDA receptor antagonist memantine has a
      neuroprotective effect on magnetic resonance spectroscopic imaging (MRS) measures of brain
      NAA and magnetic resonance imaging (MRI) volumetric measures of hippocampal volume. In
      secondary analyses, we will determine if measures of clinical stabilization produced by
      memantine in the treatment of Alzheimer's disease (AD) parallels stabilization of MRS
      measures of brain NAA and MRI volumetric measures of hippocampal volume.
    

Eligibility criteria:

        Inclusion Criteria:1. Dementia criteria by DSM-IV.

        2. 50-95 years of age inclusive.

        3. MMSE at screen and baseline 7-28 inclusive.

        4. Conversant in English.

        5. Caregiver/study partner willing to participate, supervise the patient and be available
        for administration of study medication.

        6. Able to ingest oral medication. Exclusion Criteria:1. History of clinically significant
        stroke without substantial recovery.

        2. Neurological or medical conditions causing significant disability independent of
        dementia.

        3. Parkinson's disease.

        4. History in past two years of focal brain lesion, head injury with loss of consciousness
        or DSM-IV criteria for any major psychiatric disorder including psychosis, major
        depression, bipolar disorder, alcohol or substance abuse.

        5. Dementia due to Korsakoff's syndrome or infectious diseases such as Creutzfeldt-Jakob
        disease, herpes, encephalitis, or human immunodeficiency virus.

        6. Sensory impairment that would prevent subject from participating in or cooperating with
        the protocol.

        7. Significant clinical disorder or laboratory finding that renders the subject unsuitable
        for receiving an investigational drug including: clinically significant or unstable
        hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic,
        renal, or other systemic disease or laboratory abnormality.

        8. Clinical contraindication to the use of memantine (e.g., hypersensitivity).

        9. History of seizure within past 5 years prior to screening.

        10. Platelet count < 100,000/mm3.

        11. History of claustrophobia

        12. Presence of metallic implants such as pacemakers, surgical aneurysm clips, or known
        metal fragments embedded in the body
Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan
Condition: Cold Agglutinin Disease
MeSH terms: Anemia, Hemolytic, Autoimmune
Intervention: sutimlimab
Intervention description: Pharmaceutical form: solution for injection Route of administration: intravenous (IV)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This was a multi-center, single treatment-group, open-label study to provide sutimlimab to
      the adult participants with cold agglutinin disease (CAD) who had completed the CARDINAL (NCT
      number: NCT03347396) or CADENZA (NCT number: NCT03347422) studies and benefitted from
      sutimlimab treatment in Japan.

      • Study and treatment duration: the period between the participant's completion of the
      CARDINAL and CADENZA studies and sutimlimab or other appropriate CAD therapy becoming
      commercially available to participants in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

        --Participant must be adults.

          -  Participants who had been enrolled in and had completed Part B of CARDINAL or CADENZA
             study.

          -  Participants who had ongoing diagnosis of CAD.

          -  Participants who continued to require treatment for CAD upon completion of
             participation in the previous study evidenced by return of CAD-related symptoms of
             anemia and/or deterioration on markers of hemolysis after the end of study visit
             following the 9-week safety follow up period. (9-week follow up period).

          -  Participants who had acceptable benefit/risk profile.

          -  Participant who had acceptable infection risk.

          -  Participants who had no available appropriate alternative therapy for CAD.

          -  Body weight >= 39 kg.

          -  Gave signed informed consent.

        Exclusion Criteria:

        --Clinical diagnosis of systemic lupus erythematosus or immune complex-mediated autoimmune
        disorders.

          -  Participants who met recent Rituximab and/or immunosuppressive therapy.

          -  Any of the following medical conditions:

               1. Active, serious intercurrent illness which precluded enrolment until recovery was
                  complete.

               2. Pregnancy or breast-feeding.

          -  End of Study visit in CARDINAL or CADENZA took place more than 3 months before
             Baseline visit in this study.

          -  Hypersensitivity reactions to sutimlimab or components thereof, or other allergy that,
             in the opinion of the Investigator, contraindicated participation in the study.
Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: 3% DE-089 ophthalmic solution; 0.1% sodium hyaluronate ophthalmic solution
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions; Hyaluronic Acid
Phase: Phase 3
Study type: Interventional
Enrollment: 332.0
Sex: All
Minimum age: 20 Years

Summary:

      To investigate that the efficacy of 3% DE-089 ophthalmic solution (one drop at a time, 6
      times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate
      ophthalmic solution (0.1% HA) (one drop at a time, 6 times daily, 4 weeks topical
      administration), is at least non-inferior in the change in fluorescein staining score, and is
      superior in the change in Rose bengal score, in a multicenter, double-masked, parallel-group
      comparison study. Safety profile will likewise be compared.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Those who show:

               -  Keratoconjunctival disorder confirmed with vital dye staining

               -  Abnormal Schirmer score results

        Exclusion Criteria:

          -  Eye disease that needs therapy other than that for dry eye

          -  Those who need to wear contact lenses during the clinical study