bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Dasatinib vs. High-Dose Imatinib (600 mg) in Patients With Chronic Phase Chronic Myeloid Leukemia (CML) Who Failed to Achieve Complete Cytogenetic Response After 3-18 Months of Imatinib Therapy
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: Dasatinib; Imatinib
Intervention description: Tablets, Oral, Once daily, 5-7 years; Tablets, Oral, Once daily, 5-7 years
Intervention MeSH terms: Imatinib Mesylate; Dasatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia (chronic myeloid leukemia - chronic phase)

Summary:

      The purpose of this clinical research study is to compare the rate of complete cytogenetic
      response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase
      CML patients. The safety of this treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥18 years diagnosed with Chronic Phase Philadelphia chromosome positive
             (CP Ph+) CML who have failed to achieve CCyR after 3-18 months of therapy with
             imatinib 400 mg

          -  Treatment initiation with imatinib 400 mg within 6 months of initial CML diagnosis

          -  Able to tolerate chronic administration of imatinib at the highest dose (400-600 mg)
             the subject has received in the past

          -  Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2

          -  Adequate hepatic and renal function

        Exclusion Criteria:

          -  Eligible and willing to undergo immediate autologous/allogeneic stem cell transplant

          -  Previous diagnosis of accelerated/blast crisis CML

          -  Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases

          -  Previous documentation of T315I mutation

          -  Uncontrolled or significant cardiovascular disease

          -  Serious uncontrolled medical disorder/active infection

          -  History of significant bleeding disorder unrelated to CML

          -  Intolerance to imatinib ≥400 mg

          -  Concurrent malignancies other than CML
A Study of Capecitabine (Xeloda) and Bevacizumab as a First-line Therapy in Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Oxaliplatin 130 mg/m^2; Capecitabine 1000 mg/m^2; Bevacizumab 7.5 mg/kg; Placebo for bevacizumab 7.5 mg/kg; Oxaliplatin 85 mg/m^2; Leucovorin 200 mg/m^2; Fluorouracil 400 mg/m^2; Bevacizumab 5 mg/kg; Placebo for bevacizumab 5 mg/kg
Intervention description: Oxaliplatin was administered in a 2 h infusion before the first dose of capecitabine.; Capecitabine was taken within 30 min after the end of breakfast and dinner.; Bevacizumab was administered in a 30 to 90 min infusion.; Placebo control for bevacizumab (volume equivalent to 7.5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.; Oxaliplatin 85 mg/m^2 was administered simultaneously with leucovorin in a 2 h infusion.; Leucovorin was administered simultaneously with oxaliplatin 85 mg/m^2 in a 2 h infusion.; Bevacizumab was administered in a 30 to 90 min infusion.; Placebo control for bevacizumab (volume equivalent to 5 mg/kg bevacizumab) was administered in a 30 to 90 min infusion.
Intervention MeSH terms: Leucovorin; Bevacizumab; Capecitabine; Fluorouracil; Oxaliplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 2035.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 4 arm study assessed the efficacy and safety of oral capecitabine (Xeloda) or
      intravenous (iv) fluorouracil/leucovorin, in combination with iv oxaliplatin (Eloxatin) with
      or without iv bevacizumab (Avastin), as a first-line treatment in patients with metastatic
      colorectal cancer. Patients were randomized to receive 1) XELOX (Xeloda 1000 mg/m^2 orally
      [po] twice a day [bid] on Days 1-15 + oxaliplatin in 3 week cycles), 2) FOLFOX-4 (oxaliplatin
      + leucovorin + fluorouracil [5-FU] in 2 week cycles), 3) XELOX + bevacizumab (7.5 mg iv on
      Day 1 in 3 week cycles), or 4) FOLFOX-4 + bevacizumab (5 mg iv on Day 1 in 2 week cycles).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients ≥ 18 years of age.

          -  Metastatic colorectal cancer.

          -  ≥ 1 target lesion.

        Exclusion Criteria:

          -  Previous treatment with oxaliplatin or bevacizumab.

          -  Previous systemic chemotherapy or immunotherapy for advanced or metastatic disease.

          -  Progressive disease during or within 6 months of completion of previous adjuvant
             therapy.
Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain
Condition: Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: N-methylnaltrexone bromide (MOA-728); placebo
Intervention description: Subcutaneous; placebo
Intervention MeSH terms: Bromides; Methylnaltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 460.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Opioid-Induced Constipation

Summary:

      The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of
      subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have
      Opioid-Induced Constipation (OIC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult outpatients with opioid-induced constipation and chronic non-malignant pain.

          -  Taking oral, transdermal, intravenous, or subcutaneous opioids.

          -  Willingness to discontinue all pre-study laxative therapy and use only study permitted
             rescue laxatives.

        Exclusion Criteria

          -  History of chronic constipation before the initiation of opioid therapy.

          -  Other GI disorders known to affect bowel transit.

          -  Women who are pregnant, breast-feeding, or plan to become pregnant.
Study Providing Monotherapy (Sitaxsentan) And Combination Therapy (Sitaxsentan+Sildenafil) To Subjects With Pulmonary Arterial Hypertension (PAH) To Assess Long-Term Safety
Condition: Pulmonary Arterial Hypertension; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Sitaxsentan; Sitaxsentan and Sildenafil
Intervention description: Sitaxsentan = 100 mg tablet administered orally, once daily; Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day
Intervention MeSH terms: Sildenafil Citrate; Sitaxsentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: endothelin receptor antagonist (ETRA); sitaxsentan

Summary:

      As sitaxsentan is the agent most highly selective for ETA (Endothelin Type A (receptor)), and
      does not significantly impact sildenafil pharmacokinetics the combination of most promise for
      pulmonary arterial hypertension (PAH) therapy is these two oral drugs administered in
      combination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously enrolled in B1321001 for at least 4 weeks.

          -  Previously enrolled in B1321003, discontinued from the study.

          -  Completed the B1321003 study as planned.

        Exclusion Criteria:

          -  Treated with an investigational drug (other than sitaxsentan or sildenafil in either
             B1321001 or B1321003) or device that has not received regulatory approval within the
             30 days prior to Baseline/Day 1 or during the study.
Effects of Exenatide Long-Acting Release on Glucose Control and Safety in Subjects With Type 2 Diabetes Mellitus(DURATION - 1)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: exenatide, long acting release; exenatide
Intervention MeSH terms: Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 303.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: diabetes; exenatide; long acting release; LAR; Amylin; Lilly

Summary:

      A Randomized, Open-Label, Multicenter, Comparator-Controlled Study to Examine the Effects of
      Exenatide Long-Acting Release (LAR) on Glucose Control (HbA1c) and Safety in Subjects with
      Type 2 Diabetes Mellitus Managed with Diet Modification and Exercise and/or Oral Antidiabetic
      Medications.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has type 2 diabetes mellitus treated with diet modification and exercise alone or in
             combination with a stable regimen of a combination of metformin, sulphonylureas, and
             thiazolidinediones for a minimum of 2 months at screening.

          -  Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.

          -  Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.

          -  (For sub-study) Currently participating in open ended assessment period of main study
             2993 LAR105

        Exclusion Criteria:

          -  Has been previously exposed to exenatide (Byetta®), exenatide LAR, or any
             glucagon-like peptide-1 (GLP-1) analog.

          -  Received any investigational drug or has participated in any type of clinical trial
             within 30 days prior to screening.

          -  Has been treated, is currently treated, or is expected to require or undergo treatment
             with any of the following excluded medications:

               -  Alpha glucosidase inhibitor or meglitinide within 30 days of screening;

               -  Insulin within 2 weeks prior to screening or insulin for longer than 1 week
                  within 3 months of screening;

               -  Regular use (> 14 days) of drugs that directly affect gastrointestinal motility;

               -  Regular use (> 14 days) of systemic corticosteroids by oral, intravenous, or
                  intramuscular route; or potent, inhaled, or intrapulmonary steroids known to have
                  a high rate of systemic absorption;

               -  Regular use (> 14 days) of medications with addictive potential such as opiates
                  and opioids;

               -  Prescription or over-the-counter weight loss medications within 6 months of
                  screening.

          -  (For sub-study) Subjects will be terminated from study who do not participate in the
             dual chamber pen substudy
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
Condition: Chronic Kidney Disease; Hyperparathyroidism, Secondary; Vitamin D Deficiency
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Vitamin D Deficiency; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: CTAP101 30 μg capsules; Sugar pill to CTAP101 30 μg capsules
Intervention description: CTAP101 30 μg capsule taken daily at bedtime; Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
Intervention MeSH terms: Calcifediol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 216.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Parathyroid Diseases; Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism, Secondary; Vitamin D; Hyperparathyroidism; Kidney Diseases; Kidney Failure; Renal Insufficiency, Chronic

Summary:

      This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact
      parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and
      tolerability of CTAP101 will also be evaluated
    

Eligibility criteria:

        Inclusion Criteria:

          1. Urinary albumin excretion ≤ 3000 mcg/mg of creatinine

          2. Stage 3 or 4 CKD

          3. Plasma iPTH: ≥ 85 pg/mL and < 500 pg/mL

          4. Serum Ca: ≥ 8.4 mg/dL and < 9.8 mg/dL

          5. Serum P: ≥ 2.0 mg/dL and < 5.0 mg/dL

          6. Serum 25-hydroxyvitamin D: ≥ 10 ng/mL and < 30 ng/mL.

          7. Stable dose of Vitamin D therapy ≤ 1600 IU/day and receiving same dose for at least 2
             months

        Exclusion Criteria:

          1. History of kidney transplant or parathyroidectomy

          2. Spot urine calcium:creatinine ratio > 0.2 (>200 mg/g Cr)

          3. Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event
             or hepatitis

          4. Currently on dialysis

          5. Use of pharmacological dose of ergocalciferol or cholecalciferol (≥ 50,000 IU mcg per
             month) during the study
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy
Condition: Common Variable Immunodeficiency; X-linked Agammaglobulinemia; Autosomal Recessive Agammaglobulinemia
MeSH terms: Agammaglobulinemia; Immunologic Deficiency Syndromes; Common Variable Immunodeficiency
Intervention: Human Normal Immunoglobulin for Subcutaneous Administration (IGSC)
Intervention description: IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals. The initial weekly dose was determined based on subjects' previous treatment. Dose adjustments could be performed during the wash-in/wash-out period at the discretion of the investigator.
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 2 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Subcutaneous immune globulin; SCIG

Summary:

      The objective of this study is to assess the efficacy, tolerability, safety and
      pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with primary humoral immunodeficiency, namely with a diagnosis of Common
             Variable Immunodeficiency (CVID) as defined by the Pan-American Group for
             Immunodeficiency (PAGID) and European Society for Immunodeficiencies (ESID), X-linked
             agammaglobulinemia (XLA) as defined by PAGID and ESID, or Autosomal Recessive
             Agammaglobulinemia

          -  Chest X-ray or CT scan obtained within 1 year prior to enrolment

        Exclusion Criteria:

          -  Newly diagnosed PID, i.e. subjects who have not previously received immunoglobulin
             replacement therapy

          -  Ongoing serious bacterial infection at the time of screening

          -  Malignancies of lymphoid cells such as lymphocytic leukemia, Non-Hodgkin's lymphoma
             and immunodeficiency with thymoma

          -  Allergic or other severe reactions to immunoglobulins or other blood products
             associated with high anti-IgA

        Additional criteria may apply and examination by an investigator is required to determine
        eligibility.
Efficacy and Safety of Oral Ibrexafungerp (SCY-078) vs. Placebo in Subjects With Acute Vulvovaginal Candidiasis (VANISH 303)
Condition: Candida Vulvovaginitis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal; Vulvovaginitis
Intervention: Ibrexafungerp; Placebo
Intervention description: Ibrexafungerp 300 mg BID for 1 day; Matching placebo
Intervention MeSH terms: Ibrexafungerp
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, placebo-controlled, double-blind study
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 376.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

        Subject is a postmenarchal female subject 12 years and older

        Subject has a diagnosis of symptomatic AVVC at baseline including a positive microscopic
        examination with 10% KOH in a vaginal sample revealing yeast forms (hyphae/pseudohyphae) or
        budding yeasts, and vaginal pH (≤4.5)

        Exclusion Criteria:

        Subject has any vaginal condition other than AVVC that may interfere with the diagnosis or
        evaluation of response to therapy, such as suspected or confirmed concurrent causes of
        vulvovaginitis and/or cervicitis (mixed infection)

        Need for systemic and/or topical (vaginal) antifungal treatment, including prescription or
        over-the-counter products during the study and treatment for VVC 28 days prior to
        randomization

        Subject is actively menstruating at the time of the Baseline visit.

        Subject has uncontrolled diabetes mellitus.

        Subject has a vaginal sample with pH >4.5.

        Subject has a history of or an active cervical/vaginal cancer.
Onset of Action of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray Compared With Placebo in Seasonal Allergic Rhinitis (C93-184)
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: mometasone furoate nasal spray; placebo nasal spray
Intervention description: intranasal administration; intranasal administration
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 201.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study investigated the onset of symptom relief following initiation of treatment with
      mometasone furoate (MK-0887/SCH 032088) 200 mcg administered once daily compared with placebo
      for 14 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a 2-year history of seasonal allergic rhinitis

          -  Has a positive skin test response to a local seasonal allergen (current, or performed
             in investigator's office within the past year)

          -  Is in good health and free of any unstable, clinically-significant disease, other than
             allergic rhinitis, that would interfere with the study schedule or evaluation of
             seasonal allergic rhinitis

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Women of childbearing potential who are not using an acceptable form of birth control

          -  Has asthma that requires therapy with inhaled or systemic corticosteroids, cromolyn,
             or nedocromil

          -  Has significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic,
             cerebrovascular, respiratory, gastrointestinal, or other significant medical illness
             or disorder which, in the judgment of the investigator, could interfere with the
             study, or required treatment which might interfere with the study

          -  Is on immunotherapy with the exception of maintenance therapy

          -  Has a clinically significant upper respiratory or sinus infection

          -  Has used an investigational drug within the previous 30 days

          -  Has nasal structural abnormalities, including large nasal polyps and marked septal
             deviation, that significantly interfere with nasal air flow

          -  Has a history of multiple drug allergies or an allergy to antihistamines or corticoids

          -  Has dependence upon nasal, oral or ocular decongestants, or nasal topical
             antihistamines, in the opinion of the investigator

          -  Has rhinitis medicamentosa

          -  Is using of any chronic medication which could affect the course of seasonal allergic
             rhinitis
Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Intervention: Rabeprazole sodium 5 mg; Rabeprazole sodium 10 mg; Placebo
Intervention description: Rabeprazole Sodium 5 mg capsules once daily in the morning.; Rabeprazole Sodium 10 mg capsules once daily in the morning.; Matching placebo capsules once daily in the morning.
Intervention MeSH terms: Rabeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 344.0
Sex: All
Minimum age: 1 Month
Maximum age: 11 Months
Healthy volunteers: No
Keywords: Gastroesophageal Reflux; Gastroesophageal Reflux Disease; GERD; Proton Pump Inhibitor; PPI; Regurgitation; Infants; AcipHex, PARIET; ALFENCE

Summary:

      The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an
      inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with
      placebo in the treatment of gastrointestinal esophageal reflux disease (GERD) in infants 1 to
      11 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of suspected GERD, symptomatic GERD, or endoscopically or histologically
             proven GERD, based on frequent vomiting or regurgitation, with at least 1 of the
             following: a) poor weight gain, or b) irritability, excessive crying or disturbed
             sleep that both the parent(s) and the doctor consider abnormal (but not due to colic)

          -  or c) refusal to eat even if hungry or arching of the back during meals

          -  weight 2.5 kg to 15.0 kg

          -  I-GERQ-R score >16

          -  Have only 1 caregiver in addition to the parent(s)

        Exclusion Criteria:

          -  History of confirmed acute life-threatening events due to GERD

          -  Known narrowing of the opening from the stomach to the small intestines

          -  Confirmed diagnosis of cow's milk allergy

          -  Have taken PPIs or H2-blockers (a class of drugs that inhibit stomach acid production)
             or any of several drugs that affect the normal movement of the digestive tract
             (caffeine, theophylline, antacids, erythromycin, and others) within 3 days before
             entering the study

          -  Have blood or urine test results that are well above or below the normal range for the
             infant