bioihbjkbjnl/mcl2 huggingface dataset:
Effects of GnRHa on Ovarian Function Against Chemotherapy-induced-gonadotoxicity
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: GnRHa
Intervention description: 3.6mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.
Intervention MeSH terms: Goserelin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 345.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: GnRHa; ovarian function; anti-mullerian hormone

Summary:

      This prospective randomized controlled study is conducted to analyze the effect of Goserelin
      on ovarian function in women with breast cancer in China.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal women 18 to 49 years of age are eligible for enrollment

          -  Patients have operable stage I to IIIA breast cancer for which treatment with adjuvant
             or neoadjuvant cyclophosphamide-containing chemotherapy was planned.

          -  Eligible participants had taken no estrogens, antiestrogens, selective
             estrogen-receptor modulators, aromatase inhibitors, or hormonal contraceptives within
             the month before enrollment.

          -  Human chorionic gonadotropin negative by urine test before entering the group.

          -  Informed consent, understanding and compliance with the requirements of the study.

          -  No significant chronic disease and any organ dysfunction.

        Exclusion Criteria:

          -  Exceptions were made for the use of hormonal contraception in women younger than 35
             years of age that was discontinued before randomization.

          -  Use of hormonal treatment for up to 2 months for the purposes of in vitro
             fertilization and cryopreservation of embryos or oocytes before randomization.

          -  Patients with metastatic lesions or history of bilateral ovariectomy,ovarian radiation
             were excluded.

          -  Patients received previous adjuvant endocrine therapy for breast cancer are not
             suitable to this trial.

          -  Patients with uterine and/or adnexal diseases needing medical or surgical treatment
             are not suitable.

          -  Allergic to active or inactive excipients of GnRHa is an exclusion criterion.
Loteprednol Etabonate Ophthalmic Ointment vs. Vehicle in the Treatment of Inflammation Following Cataract Surgery
Condition: Ocular Inflammation
MeSH terms: Cataract; Inflammation
Intervention: 0.5% Loteprednol Etabonate Ophthalmic Ointment; Vehicle of Loteprednol Etabonate Ophthalmic Ointment
Intervention description: 1/2 inch ribbon four times a day for 14 days; 1/2 inch ribbon four times a day for 14 days
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 400.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the clinical safety and efficacy of Loteprednol Etabonate Ophthalmic Ointment,
      0.5% vs. vehicle for the treatment of inflammation following cataract surgery
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects who are candidate for routine, uncomplicated cataract surgery

          2. Subjects who, in the Investigator's opinion, have potential postoperative pinholed
             Snellen visual acuity (VA) of at least 20/200 in the study eye.

        Exclusion Criteria:

          1. Subjects who will require concurrent ocular therapy with NSAIDs, mast cell
             stabilizers, antihistamines, decongestants, or immunosuppressants (e.g., Restasis), or
             with ocular or systemic corticosteroids

          2. Subjects who have known hypersensitivity or contraindication to the study drug(s) or
             their components

          3. Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the
             non-study eye

          4. Subjects who have had ocular surgery (including laser surgery) in the study eye within
             3 months or in the fellow eye within 2 weeks prior to the Screening Visit
Evaluation of the Long-term Safety and Tolerability of Metoprolol Versus Nebivolol in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Nebivolol (NEB); Metoprolol (MET)
Intervention description: Patients randomized to nebivolol will initiate therapy with nebivolol 5 mg once daily for 4 weeks.; Patients randomized to metoprolol will initiate therapy with 100 mg once daily for 4 weeks.
Intervention MeSH terms: Metoprolol; Nebivolol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 336.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: safety and tolerability study; hypertension; beta-blockers

Summary:

      The purpose of this study is to evaluate long-term safety,tolerability and blood pressure
      effects of metoprolol versus nebivolol in patients with hypertension. These drugs may be
      given alone or in combination with other drugs that are commonly used in the treatment of
      hypertension
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of previous nebivolol study

          -  Stage 1-2 Hypertension (HTN) at baseline of first study

        Exclusion Criteria:

          -  Recent myocardial infarction or stroke

          -  Contraindications to beta blocker therapy
A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Placebo
Intervention description: Administered SC as add-on to the pre-trial background medication.; Administered SC as add-on to the pre-trial background medication.
Intervention MeSH terms: Tirzepatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 475.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glucose-dependent insulinotropic polypeptide (GIP); glucagon-like peptide-1 (GLP-1); GIP/GLP-1 dual receptor agonist; T2DM

Summary:

      The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide
      to placebo in participants with type 2 diabetes that are already on insulin glargine, with or
      without metformin. Participants will administer tirzepatide or placebo along with their
      previous glucose lowering medications. The study will last approximately 47 weeks and may
      include about 23 visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been diagnosed with type 2 diabetes mellitus (T2DM) and have been treated with
             insulin glargine (U100), once daily with or without metformin ≥3 months prior to
             screening visit.

          -  Have HbA1c between ≥7.0% and ≤10.5%.

          -  Have a stable weight (± 5%) for at least 3 months before screening.

          -  Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²) at screening.

        Exclusion Criteria:

          -  Have type 1 diabetes mellitus.

          -  Have had chronic or acute pancreatitis any time prior to study entry.

          -  Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative
             diabetic retinopathy requiring acute treatment.

          -  Have disorders associated with slowed emptying of the stomach, or have had any stomach
             surgeries for the purpose of weight loss.

          -  Have an estimated glomerular filtration rate <30 mL/minute/1.73 m² [for participants
             on metformin, estimated glomerular filtration rate <45 mL/min/1.73 m2 (or lower than
             the country-specific threshold for using the protocol-required dose of metformin per
             local label)]

          -  Have had a heart attack, stroke, or hospitalization for congestive heart failure in
             the past 2 months.

          -  Have a personal or family history of medullary thyroid carcinoma or personal history
             of multiple endocrine neoplasia syndrome type 2.

          -  Have been taking weight loss drugs, including over-the-counter medications during the
             last 3 months.
Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Intervention: 13-valent pneumococcal conjugate vaccine (13vPnC); 23-valent Pneumococcal Polysaccharide Vaccine (23vPS); 13-valent pneumococcal conjugate vaccine (13vPnC); 13-valent pneumococcal conjugate vaccine (13vPnC); 13-valent pneumococcal conjugate vaccine (13vPnC); 23-valent Pneumococcal Polysaccharide Vaccine (23vPS); 13-valent pneumococcal conjugate vaccine (13vPnC)
Intervention description: 0.5 mL dose administered on day 1; 0.5 mL dose administered on day 1; 0.5 mL dose administered on day 1; 0.5 mL dose administered on day 1; 0.5 mL dose administered 3-4 years after dose 1; 0.5 mL dose administered 3-4 years after dose 1; 0.5 mL dose administered 3-4 years after dose 1
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2141.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine; Pneumococcal Infections Prevention and Control

Summary:

      This study will assess the safety, tolerability and immune response of 13-valent pneumococcal
      conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine
      (23vPS). Although the study started with only 1 population, amendments to the original
      protocol will now reflect three participant populations. Three age cohorts will be enrolled.
      The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49)
      are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart.
      Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS.
      Comparisons of immune responses from the different cohorts will be done.
    

Eligibility criteria:

        Inclusion Criteria:

          -  First Cohort: Healthy Male and female adults 60 to 64 years of age at time of
             enrollment.

          -  Second Cohort: Healthy Male and female adults 50 to 59 years of age at time of
             enrollment.

          -  Third Cohort: Healthy Male and female adults 18 to 49 years of age at time of
             enrollment.

        Exclusion Criteria:

          -  Previous immunization with any licensed or experimental pneumococcal vaccine.

          -  Serious chronic disorders including metastatic malignancy, severe chronic obstructive
             pulmonary disease (COPD) requiring supplemental oxygen, end stage renal disease with
             or without dialysis, clinically unstable cardiac disease, or any other disorder which
             in the investigator's opinion precludes the subject from participating in the study.

          -  Known or suspected impairment of immunological function.
Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Exenatide Once Weekly; Placebo
Intervention description: Subcutaneous injection, 2 mg, administered once weekly.; Subcutaneous injection, matching volume of placebo, administered once weekly.
Intervention MeSH terms: Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 14752.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: exenatide once weekly; cardiovascular; Bydureon; Amylin

Summary:

      This study will compare the impact of including exenatide once weekly in addition to usual
      care vs. usual care without exenatide on major cardiovascular outcomes as measured by the
      primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction
      (MI), or nonfatal stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has type 2 diabetes mellitus

          -  Patient has an HbA1c of ≥ 6.5 % and ≤ 10.0% and is currently using one of the
             following treatment regimens: A) Treatment with 0-3 oral antihyperglycemic agents B)
             Insulin therapy, either alone or in combination with up to two oral agents

          -  Female patients must not be breast feeding and agree to use an effective method of
             contraception or must not otherwise be at risk of becoming pregnant.

        Exclusion Criteria:

          -  Patient has a diagnosis of type 1 diabetes mellitus, or a history of ketoacidosis.

          -  Patient has ever been treated with an approved or investigational GLP-1 receptor
             agonist.

          -  Patient is enrolled in another experimental protocol which involves the use of an
             investigational drug or device, or an intervention that would interfere with the
             conduct of the trial.

          -  Patient has a planned or anticipated revascularization procedure.

          -  Pregnancy or planned pregnancy during the trial period.

          -  Patient has end-stage renal disease or an estimated glomerular filtration rate (eGFR)
             of <30 mL/min/1.73m2.

          -  Patient has a history of gastroparesis or pancreatitis.

          -  Personal or family history of medullary thyroid cancer or MEN2 (Multiple
             EndocrineNeoplasia Type 2) or calcitonin level of >40 ng/L at baseline.
TREXIMET (Formerly Known as TREXIMA) for the Acute Treatment of Probable Migraine (ICHD-II 1.6.1)
Condition: Migraine, Without Aura
MeSH terms: Migraine Disorders
Intervention: sumatriptan succinate / naproxen sodium; Placebo
Intervention description: sumatriptan 85mg / naproxen sodium 500mg; Placebo to match Treximet tablets
Intervention MeSH terms: Naproxen; Sumatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 679.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: sumatriptan succinate,; naproxen sodium,; parallel group,; double-blind,; placebo-controlled,; Combination product,; migrainous headache; Probable migraine, a sub-type of Migraine; probable migraine,

Summary:

      This study was designed to determine the efficacy and tolerability of TREXIMET (formerly
      known as TREXIMA) compared to placebo for the acute treatment of probable migraine, a
      sub-type of migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least a 6 month history of probably migraine (6 migraine attacks per month)

          -  Males and women of childbearing potential on a adequate contraception.

        Exclusion Criteria:

          -  Physician diagnosis of migraine; history of triptan or ergot use; history of headache
             prophylaxis use

          -  Pregnant and/or nursing mother

          -  History of cardiovascular disease.

          -  Uncontrolled hypertension.

          -  Basilar or Hemiplegic migraine

          -  History of stroke or transient ischemic attacks (TIA).

          -  History of epilepsy or treated with anti-epileptics within the past 5 years.

          -  Impaired hepatic or renal function.

          -  History of gastrointestinal bleeding or ulceration.

          -  Allergy or hypersensitivity to Aspirin or any other NSAID.

          -  Allergy or hypersensitivity to triptans.

          -  Participated in an investigational drug trial in the previous 4 weeks.
Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC); Aclidinium bromide/formoterol Fixed-Dose Combination (FDC); Aclidinium bromide; Formoterol Fumarate; Placebo
Intervention description: Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day; Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose, twice per day; Inhaled Aclidinium bromide 400 μg, twice per day; Inhaled Formoterol Fumarate 12 μg, twice per day; Inhaled dose-matched placebo, twice per day
Intervention MeSH terms: Bromides; Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 921.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Chronic Obstructive Pulmonary Disease; Chronic Bronchitis; Emphysema; Airflow Obstruction, Chronic; Chronic Airflow Obstruction; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease

Summary:

      The purpose of this Phase III study is to evaluate the long-term safety and tolerability of
      two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium
      bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic
      Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related
      quality of life assessments will also be evaluated. This extension study will include a 28
      week treatment period, followed by a four week follow up visit. All patients will remain in
      the same treatment group as for the lead-in study and continue on one of the four treatment
      arms or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of the treatment phase of the lead-in study, LAC-MD-31

          -  Written informed consent obtained from the patient before the initiation of any study
             specific procedures

          -  No medical contraindication as judged by the PI

          -  Compliance with LAC-MD-31 study procedures and IP dosing.

        Exclusion Criteria:

          -  No specific exclusion criteria
Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms
Condition: Major Depressive Disorder; Anxiety
MeSH terms: Anxiety Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Brexpiprazole
Intervention description: Treatment (6 weeks) - Up to 3mg/day, once daily dose, tablets, orally
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: schizophrenia; Major depressive disorder; Anxiety Symptoms; Mental Disorders; Psychotic Disorders; emotional withdrawal; antipsychotic

Summary:

      The purpose of this study is to investigate the efficacy and safety of flexibly dosed
      adjunctive brexpiprazole treatment in subjects with major depressive disorder and anxiety
      symptoms, who are experiencing an inadequate selective serotonin reuptake inhibitor
      (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) response.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Have a diagnosis of a single or recurrent, nonpsychotic episode of MDD as defined by
             the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text
             Revision (DSM-IV-TR) and confirmed by both the Mini International Neuropsychiatric
             Interview (M.I.N.I.) and an adequate clinical psychiatric evaluation.

          -  Have a treatment history of an inadequate ADT response to at least 1 ADT (but not > 3)
             for the current episode.

          -  Have received a single, trial-approved, SSRI or SNRI at an adequate dose for

             ≥ 6 weeks prior to screening.

          -  Are 18 to 65 years old at the time of consent (inclusive, and outpatients only).

          -  Have a Hamilton Depression Rating Scale (HAM-D)-17-item Total Score ≥ 18 at screening
             and baseline.

          -  Have a Hamilton Anxiety Rating Scale (HAM-A) Total Score ≥ 20 at screening and
             baseline.

        Main Exclusion Criteria:

        Subjects with any of the following current Axis I DSM-IV-TR diagnoses:

          -  delirium

          -  dementia

          -  amnestic

          -  other cognitive disorders

          -  schizophrenia

          -  schizoaffective disorder

          -  other psychotic disorders

          -  bipolar I disorder,

          -  bipolar II disorder

          -  bipolar disorder not otherwise specified (NOS)

          -  eating disorders

          -  anorexia nervosa

          -  bulimia

          -  obsessive compulsive disorder

          -  post-traumatic stress disorder

        Subjects with any of the following current Axis II DSM-IV-TR diagnoses:

          -  borderline, antisocial

          -  paranoid

          -  schizoid

          -  schizotypal

          -  histrionic personality disorders

          -  mental retardation.