bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate the Efficacy and Safety of Different Doses of Losartan Potassium (MK0954-011)
Condition: Hypertension
MeSH terms: Hypertension
Intervention: losartan potassium; Placebo; Enalapril
Intervention description: losartan oral capsule (10, 25, 50, 100 or 150 mg) once daily for 8 weeks; Placebo capsule to losartan; Enalapril 20 mg oral tablet taken once daily for 8 weeks
Intervention MeSH terms: Losartan; Enalapril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 576.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to compare the antihypertensive efficacy of different doses of
      losartan compared to placebo and enalapril, in patients with supine diastolic blood pressure
      of 100-115 mmHg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has been diagnosed with mild to moderate hypertension, with supine diastolic
             blood pressure of 100 to 115 mmHg

          -  Patient has no active medical problems other than essential hypertension that might
             affect blood pressure

          -  Patient has received no drug therapy that might affect blood pressure

        Exclusion Criteria:

          -  Prior exposure to losartan

          -  History of stroke

          -  History of myocardial infarction

          -  Atrial flutter or atrial fibrillation

          -  History of congestive Heart failure

          -  Known Sensitivity to ACE inhibitors

          -  Known positive test for HIV/AIDS or Hepatitis B

          -  Patient is being treated for acute ulcer disease

          -  History of chronic liver disease

          -  Actively treated diabetes mellitis

          -  Any known bleeding or platelet disorder

          -  Absence of one kidney

          -  Women of childbearing potential or who are breastfeeding

          -  Patient is abusing or has a history of alcoholism or drug addiction
Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED)
Condition: Chemotherapy-induced Nausea and Vomiting (CINV)
MeSH terms: Nausea; Vomiting
Intervention: aprepitant; Comparator: Placebo to aprepitant; dexamethasone; granisetron; dexamethasone
Intervention description: Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg; Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg; Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg; Day 1: IV granisetron 3 mg prior to administration of cisplatin; Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Aprepitant; Fosaprepitant; Granisetron; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 421.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CINV

Summary:

      This study will demonstrate and confirm the efficacy and safety of MK0869 for the treatment
      of chemotherapy-induced nausea and vomiting in Chinese patients.
    

Eligibility criteria:

        Inclusion Criteria:

        Cycle 1:

          -  Patient is scheduled to receive his/her first course of cisplatin chemotherapy at a
             dose of at least 70 mg/m^2 administered a maximum of 3 hours

          -  Patient has a predicted life expectancy of at least 3 months

          -  Patient is not pregnant

        Cycle 2 (optional):

          -  Participation in the study during the next cycle of chemotherapy is considered

        appropriate by the investigator and will not pose unwarranted risk to the patient.

          -  Satisfactory completion of the preceding cycle of chemotherapy and related

        study procedures.

          -  Patient will continue to receive the same chemotherapy regimen as in Cycle 1. The
             cisplatin dose may be reduced in subsequent cycle, as long as the new

        dose is still no less than 70 mg/m^2.

        Exclusion Criteria:

        Cycles 1 & 2:

          -  Patient will receive stem cell therapy in conjunction with cisplatin

          -  Patient has an active infection or any uncontrolled disease (e.g. diabetes)

          -  Patient will receive multiple-day chemotherapy with cisplatin

          -  Patient will receive chemotherapy of moderate or high emetogenicity on the 6 days
             prior to cisplatin infusion or the 6 days following the cisplatin infusion

          -  Patient has vomited within 24 hours prior to cisplatin infusion

          -  Patient received or will receive radiation therapy to the abdomen
A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; IVA
Intervention description: Fixed dose combination (FDC) tablets for oral administration.; Tablets for oral administration.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study was evaluate the effect of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) on
      glucose tolerance in CF participants, 12 years of age and older who are heterozygous for the
      F508del mutation and a minimal function mutation (F/MF genotypes), with abnormal glucose
      metabolism.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Heterozygous for F508del and an MF mutation (F/MF genotypes)

          -  Forced expiratory volume in 1 second (FEV1) value ≥ 30% of predicted mean for age,
             sex, and height

          -  Abnormal glucose tolerance determined by an OGTT as either:

               -  Impaired glucose tolerance (IGT) defined as 2 hour post OGTT blood glucose level
                  ≥140 to <200 mg/dL (≥7.77 to <11.10 mmol/L) and fasting blood glucose level <126
                  mg/dL (<7.00 mmol/L)

               -  CF-related diabetes (CFRD) defined as either fasting hyperglycemia (blood glucose
                  level ≥126 mg/dL [≥7.00 mmol/L] after an 8-hour fast) or 2-hour post OGTT blood
                  glucose level ≥200 mg/dL (≥11.10 mmol/L)

        Key Exclusion Criteria:

          -  Clinically significant liver cirrhosis with or without portal hypertension

          -  Solid organ or hematological transplantation

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

          -  Type 1 or Type 2 diabetes

          -  Duration of CFRD ≥5 years

        Other protocol defined Inclusion/Exclusion criteria may apply.
Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Placebo
Intervention description: Tablets, Oral, 5mg, once daily, 4 weeks; Tablets, Oral, 0 mg, once daily, 4 weeks
Intervention MeSH terms: Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Maximum age: 77 Years
Healthy volunteers: No

Summary:

      This protocol will compare 24 hour glucose control for subject taking saxagliptin and
      metformin extended release (XR) versus metformin XR alone
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥18- and ≤77-years-old

          -  Type 2 diabetes

          -  Taking metformin immediate release (IR) or XR ≥1500 mg for at least 8 weeks as
             monotherapy

          -  Glycosylated hemoglobin (A1C) ≥7% and ≤10%

          -  Body mass index (BMI) ≤40 kg/m2

        Exclusion Criteria:

          -  Women of childbearing potential unable or unwilling to use acceptable birth control

          -  Women who are pregnant or breastfeeding

          -  Significant cardiovascular history

          -  Active liver disease

          -  Renal impairment
Glucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL
Condition: Acute Lymphoblastic Leukemia (ALL)
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Glucarpidase
Intervention description: Patients treated with Glucarpidase if the 24 hour levels of MTX is >250 µM, 36 hour levels >30 µM or 42 hours levels >10 µM together with a reduced kidney function will be compared with patients in just below the tricking values.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Drug: Glucarpidase

Summary:

      Early intervention in children and adolescents who experience delayed MTX-clearance and renal
      dysfunction in ALL treatments with the enzyme Glucarpidase which rapidly hydrolyses MTX to
      non-toxic metabolites to avoid life threatening complications.
    

Eligibility criteria:

        Inclusion Criteria:

        Children and adolescents who experience delayed MTX-clearance and renal dysfunction during
        high-dose methotrexate treatment in NOPHO ALL-2008.

        Exclusion Criteria:

        Children and adolescents with earlier anaphylactic reaction to Glucarpidase. Pregnant
        patients.
A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases
Condition: Gastric Ulcer (GU); Duodenal Ulcer (DU); Anastomotic Ulcer (AU); Non-erosive Reflux Esophagitis Disease (NERD); Reflux Esophagitis (RE); Zollinger-Ellison Syndrome
MeSH terms: Zollinger-Ellison Syndrome; Gastrinoma; Gastroesophageal Reflux; Esophagitis, Peptic; Esophagitis; Stomach Ulcer; Duodenal Ulcer; Ulcer
Intervention: D961H sachet 10 mg; D961H capsule 10mg; D961H capsule 20 mg
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 1 Year
Maximum age: 14 Years
Healthy volunteers: No
Keywords: Gastric ulcer (GU); Duodenal ulcer (DU); Anastomotic ulcer (AU); Non-erosive reflux esophagitis disease (NERD); Reflux esophagitis (RE); Zollinger-Ellison syndrome

Summary:

      The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and
      efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in
      Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are
      suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU),
      non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison
      syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed written informed consent from the patient's guardian

          -  Patients aged ≥ 1 year to 14 years old

          -  Patients who have a diagnosis of or suspected to have GU, DU, AU, NERD, RE or
             Zollinger-Ellison syndrome.

        Exclusion Criteria:

          -  Patients less than 10 kg in weight.

          -  Use of any other investigational compounds or participations in another clinical trial
             within 4 weeks prior to the randomisation/registration.

          -  Significant clinical illness within 4 weeks prior to the registration

          -  Presence of hepatic diseases or other conditions that could interfere with evaluation
             of the study as judged by the investigators.

          -  Positive for pregnancy test by urinary or lactation for post-menarchal females.

          -  Previous total gastrectomy
Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Pirfenidone; Placebo
Intervention description: 1197 or 2403 mg/day given orally, and administered in divided doses three times daily with food, for the duration of the study.; Placebo equivalent, given orally, and administered in divided doses three times daily with food, for the duration of the study.
Intervention MeSH terms: Pirfenidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 435.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Idiopathic; Pulmonary; Fibrosis; Lung; Pirfenidone; InterMune

Summary:

      The objectives of this study are to assess the safety and efficacy of treatment with
      pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic
      pulmonary fibrosis (IPF), to assess the safety and efficacy of treatment with pirfenidone
      1197 mg/d in patients with idiopathic pulmonary fibrosis and to characterize the
      pharmacokinetic disposition of pirfenidone in patients with idiopathic pulmonary fibrosis.
    

Eligibility criteria:

        Primary Inclusion criteria:

          -  diagnosis of idiopathic pulmonary fibrosis

          -  40 to 80 years of age

          -  Forced Vital Capacity greater than or equal to 50% predicted value

          -  Carbon monoxide diffusing capacity greater than or equal to 35% predicted value

          -  either Forced Vital Capacity or Carbon monoxide diffusing capacity less than or equal
             to 90% predicted value

          -  no improvement in past year

          -  able to walk 150 meters in 6 minutes and maintain saturation greater than or equal to
             83% while on no more than 6 liters per minute (L/min) supplemental oxygen

        Primary Exclusion criteria:

          -  unable to undergo pulmonary function testing

          -  evidence of significant obstructive lung disease or airway hyper-responsiveness

          -  in opinion of investigator patient is expected to need and be eligible for a lung
             transplant within 72 weeks after randomization

          -  active infection

          -  liver disease

          -  cancer or other medical condition likely to result in death within 2 years

          -  diabetes

          -  pregnancy or lactation

          -  substance abuse

          -  personal or family history of long QT (Q wave,T wave) syndrome

          -  other IPF treatment

          -  unable to take study medication

          -  withdrawal from other IPF trials
A Phase III Study of PA21 With Calcium Carbonate in Hemodialysis Patients With Hyperphosphatemia
Condition: Hemodialysis; Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Intervention: PA21
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Hemodialysis; Hyperphosphatemia

Summary:

      The purpose of this study is to investigate the safety and efficacy when administering PA21
      with calcium carbonate in hemodialysis patients with hyperphosphatemia for 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Receiving stable maintenance hemodialysis 3 times a week

          -  Dialysis patients with hyperphosphatemia

        Exclusion Criteria:

          -  Patients having history of a pronounced brain / cardiovascular disorder

          -  Patients having severe gastrointestinal disorders

          -  Patients having severe hepatic disorders
Aripiprazole in Children and Adolescents With Bipolar I Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Aripiprazole; Aripiprazole; placebo
Intervention description: Treatment Arm 1 (10 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, and aripiprazole 10 mg QD as the target dose starting on Day 5. Subjects remained on the 10 mg dose for the remainder of the treatment period Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase.; Treatment Arm 2 (30 mg treatment arm): Aripiprazole 2 mg QD for 2 days, aripiprazole 5 mg QD for 2 days, aripiprazole 10 mg QD for 2 days, aripiprazole 15 mg QD for 2 days, aripiprazole 20 mg QD for 2 days, aripiprazole 25 mg QD for 2 days, and aripiprazole 30 mg QD as the target dose starting on Day 13. Subjects remained on the 30 mg dose for the remainder of the treatment period. Subjects reached their target dose through a forced titration schedule and proceeded with treatment at their target dose until Week 4. If the subject reached Week 4, he or she continued into the Extension Phase, a 6-month double-blind treatment period, beginning at the same dose taken at the end of the Acute Phase.; Placebo tablet
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 296.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Aripiprazole; Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features

Summary:

      The purpose of this trial is to test the safety and efficacy of two doses of aripiprazole in
      child and adolescent patients with bipolar I disorder, manic or mixed episode with or without
      psychotic features.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Child and adolescent patients with bipolar I disorder, manic or mixed episode with or
             without psychotic features

        Exclusion Criteria:

          -  Patients with certain other psychological disorders

          -  Patients with a co-morbid serious, uncontrolled systemic illness

          -  Patients with significant risk of committing suicide
PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)
Condition: Hepatitis; Hepatitis C, Chronic; Fibrosis; Liver Cirrhosis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Liver Cirrhosis
Intervention: PegIntron (peginterferon alfa-2b; SCH 54031); REBETOL (ribavirin; SCH 18908)
Intervention description: PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks; REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b; Interferon-alpha
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2333.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus
      REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to
      severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha
      interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus
      REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the
      effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease
      progression (Protocols P02569 and P02570).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age at entry 18-65

          -  Positive for Hepatitis C

          -  Nonresponder to previous treatment (minimum of 3 months) with an alpha Interferon plus
             ribavirin

          -  Liver biopsy demonstrating moderate to severe fibrosis or cirrhosis

        Exclusion Criteria:

          -  Any cause for the liver disease other than chronic hepatitis C

          -  History or presence of complications of cirrhosis

          -  Alcohol or illicit drug use or methadone treatment within the past 2 years

          -  Treatment for chronic hepatitis C within the previous 6 months

          -  Diseases or conditions that could interfere with the subject's participation in and
             completion of the study
ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas
Condition: Anaplastic Large-Cell Lymphoma; Non-Hodgkin Lymphoma; T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Large-Cell, Anaplastic
Intervention: brentuximab vedotin; doxorubicin; prednisone; vincristine; cyclophosphamide
Intervention description: 1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles; 50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles; 100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles; 1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles; 750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
Intervention MeSH terms: Prednisone; Cyclophosphamide; Doxorubicin; Vincristine; Brentuximab Vedotin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 452.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antibodies, Monoclonal; Antibody-Drug Conjugate; Antigens, CD30; Drug Therapy; Hematologic Diseases; Lymphoma; Monomethyl auristatin E; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Anaplastic

Summary:

      This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the
      efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care
      CHOP in patients with CD30-positive mature T-cell lymphomas.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with newly diagnosed, CD30-positive mature T-cell lymphomas

          -  Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm
             by CT

          -  Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

        Exclusion Criteria:

          -  History of another primary invasive malignancy that has not been in remission for at
             least 3 years

          -  Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative
             disorders and lymphomas or mycosis fungoides

          -  History of progressive multifocal leukoencephalopathy (PML)

          -  Cerebral/meningeal disease related to the underlying malignancy