bioihbjkbjnl/mcl2 huggingface dataset:
A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Sorafenib (Nexavar, BAY43-9006); Placebo
Intervention description: Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment.; Sorafenib-matching placebo tablets were orally administered twice daily (bid).
Intervention MeSH terms: Sorafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 602.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Liver Cancer; Cancer

Summary:

      The purpose of the study is: Find out if patients receiving sorafenib will live longer. Find
      out if sorafenib has any effect on patient reported outcomes. Find out if sorafenib prevents
      the growth of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics
      (PK) in patients with liver cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages eligible for study: 18 years and above, Genders eligible for study: both

          -  Patients who have a life expectancy of at least 12 weeks

          -  Patients with histologically or cytologically documented Hepatocellular Carcinoma
             (HCC)

          -  Patients must have at least one tumor lesion that meets both of the following
             criteria: (1) Accurately measured in at least one dimension according to RECIST
             (Response Evaluation Criteria in Solid Tumors) (2) Not previously treated with local
             therapy

          -  Patients who have an ECOG (Eastern Cooperative Oncology Group) PS (Performance Status)
             of 0, 1, or 2

        Exclusion Criteria:

          -  Previous or concurrent cancer that is distinct in primary site or histology from HCC,
             EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder
             tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"] &
             T1 [Tumor invades subepithelial connective tissue]). Any cancer curatively treated > 3
             years prior to entry is permitted

          -  Renal failure requiring hemo- or peritoneal dialysis

          -  History of cardiac disease

          -  Active clinically serious infections

          -  Known history of human immunodeficiency virus (HIV) infection

          -  Known central nervous system tumors including metastatic brain disease

          -  Patients with clinically significant gastrointestinal bleeding within 30 days prior to
             study entry
Comparative Effectiveness of Pregnancy Failure Management Regimens
Condition: Spontaneous Abortion
MeSH terms: Abortion, Spontaneous
Intervention: Misoprostol; Mifepristone
Intervention MeSH terms: Misoprostol; Mifepristone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Spontaneous abortion; Early Pregnancy Failure; Mifepristone; Misoprostol

Summary:

      The purpose of the study is to compare the effectiveness of combination treatment
      (mifepristone premedication plus single-dose misoprostol) to single-dose misoprostol
      (standard of care) for the management of early pregnancy failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  between 5 and 12 completed weeks gestation

          -  18 years or older

          -  hemodynamically stable

          -  confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation
             (ultrasound examination demonstrates a fetal pole without cardiac activity measuring
             between 5.3 and 40 mm or an abnormal growth pattern diagnostic of early pregnancy
             failure)

          -  willing and able to give informed consent

        Exclusion Criteria:

          -  diagnosis of incomplete or inevitable abortion (absent gestational sac and/or active
             bleeding, open cervical os)

          -  contraindication to mifepristone (chronic corticosteroid administration, adrenal
             disease)

          -  contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, or
             known allergy to prostaglandin)

          -  cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure)

          -  most recent hemoglobin <9.5 g/dL

          -  diagnosis of porphyria

          -  known clotting defect or receiving anticoagulants

          -  pregnancy with an intrauterine device (IUD) in place

          -  breastfeeding during the first 7 days of study participation

          -  unwilling to comply with the study protocol and visit schedule

          -  any evidence of viable pregnancy

          -  possibility of ectopic pregnancy

          -  known or suspected pelvic infection

          -  concurrent participation in any other interventional trial
Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Faster-acting insulin aspart; insulin aspart; insulin degludec
Intervention description: Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal. Postmeal dosing is defined as injecting 20 minutes after the start of the meal.; Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal.; Injected subcutaneously (under the skin) once daily for 26 weeks. Dose individually adjusted
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1108.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and North America. The purpose is to confirm efficacy
      in terms of glycaemic control of treatment with mealtime faster-acting insulin aspart in
      combination with insulin degludec in adults with Type 1 Diabetes Mellitus.
    

Eligibility criteria:

        Inclusion Criteria: - Male or female, age greater than or equal to 18 years ( for Japan and
        Taiwan: age greater than or equal to 20 years) at the time of signing informed consent -
        Type 1 Diabetes Mellitus (based on clinical judgement and/or supported by laboratory
        analysis as per local guidelines) 12 months or more prior to screening - Currently treated
        with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) -
        Currently treated with a basal insulin analogue for at least 4 months prior to screening
        (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central
        laboratory - Body Mass Index less than or equal to 35.0 kg/m^2 Exclusion Criteria: - Within
        the past 180 days any of the following: myocardial infarction, stroke or hospitalization
        for unstable angina and/or transient ischemic attack - Subjects presently classified as
        being in New York Heart Association (NYHA) Class IV Currently planned coronary, carotid or
        peripheral artery revascularisation - Diabetic ketoacidosis requiring hospitalisation
        within the last 180 days prior to screening (Visit 1) - Treatment with any medication for
        the indication of diabetes or obesity other than stated in the inclusion criteria in a
        period of three months before screening (Visit 1)
Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Valsartan 0.25 mg/kg; Valsartan 1.0 mg/kg; Valsartan 4.0 mg/kg
Intervention description: once daily; once daily; once daily
Intervention MeSH terms: Valsartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 74.0
Sex: All
Minimum age: 6 Months
Maximum age: 5 Years
Healthy volunteers: No
Keywords: Children; pediatrics; High Blood Pressure; Hypertension; Valsartan

Summary:

      The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan
      (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting
      diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting
      systolic blood pressure [SSBP] ≥ 95th percentile ).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 6 months - 5 years at Visit 1, with a documented history of hypertension

          -  Must be able to swallow liquid formulation

          -  Must be ≥ 6 kg or ≤ 40 kg at randomization

          -  Must have documented history MSSBP (mean of 3 measurements) must be ≥ 95th percentile
             for age, gender and height, at randomization

          -  If patients enter with uncontrolled BP they can remain on background antihypertensives
             with an unchanged dosing regimen

          -  If patients have had a solid organ transplant more than 1 year ago they must be on
             stable doses of immunosuppressive therapy

          -  Parent(s)/guardian(s) are able to follow verbal and/or written instructions in the
             local language

        Exclusion Criteria:

          -  Patients with background ARB therapy

          -  Patients demonstrating any clinically significant abnormalities or clinically
             noteworthy abnormal lab values (other than those relating to renal function)

          -  AST/SGOT or ALT/SGPT > 3 times the upper limit of the reference range

          -  Glomerular filtration rate < 30 mL/min/1.73m²

          -  Serum potassium > upper limit of the reference range

          -  MSSBP ≥ 25% above the 95th percentile

          -  Patients exhibiting clinically significant ECG abnormalities

          -  Patients that have coarctation of the aorta with a gradient of ≥ 30 mm Hg, or renal
             artery stenosis

        Other protocol-defined inclusion/exclusion criteria may apply
A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Condition: Active Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept; Placebo
Intervention description: Vials (250 mg/vial), intravenous (IV), 10 mg/kg, monthly infusion , 12 months of treatment; Intravenous (IV) bags, IV, 0 mg, monthly infusion, 12 months of treatment
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The only trial in participants who are methotrexate-inadequate responders and have active
      Rheumatoid Arthritis, in which gadolinium-enhanced Magnetic Resonance Imaging; Bone Mineral
      Density; and biochemical markers of bone, cartilage, and synovial tissue metabolism are used
      to evaluate early effects (4 months) of Abatacept on inflammation/structural damage. Study
      will provide valuable mechanism-of-action information on how Abatacept exerts its effects
      (including on bone) through new techniques.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Disease activity as defined by a Disease Activity Score 28-C-Reactive Protein (CRP)
             >3.2 or >6 swollen and ≥6 tender joints and CRP greater than the upper limit of normal

          -  At least 1 erosion in hands/wrists or positive anticyclic citrullinated peptides or
             rheumatoid factor

          -  Clinically detectable synovitis of at least 1 wrist/ankle at screening and baseline

          -  Participants must have been treated with methotrexate, on a weekly dose of at least 15
             mg or a maximum tolerated dose (such as, 10 mg weekly) for at least 3 months before
             screening. Dose of methotrexate must be stable for at least 28 days prior to the first
             study dose (Day 1)
A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: belimumab
Intervention description: Recombinant, fully human, monoclonal antibody
Comparison of the 1 mg/kg and 10 mg/kg dose of belimumab given IV every 28 days.
Intervention MeSH terms: Belimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 738.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SLE; Belimumab; Antibodies; Systemic Lupus Erythematosus; Lupus; Autoimmune Diseases

Summary:

      This is a long-term continuation study to provide continuing treatment to subjects with SLE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have completed the HGS 1006-C1056 or HGS 1006-C1057 protocol through the Week 72 or
             Week 48 visits, respectively.

        Exclusion Criteria:

          -  Have developed any other medical disease or condition that has made the patient
             unsuitable for this study in the opinion of their physician.
Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan
Condition: Hypertension
MeSH terms: Hypertension
Intervention: LCZ696; Olmesartan; Placebo of LCZ696; Placebo of Olmesartan
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil; Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 376.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hypertension,; LCZ696,; olmesartan

Summary:

      This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in
      essential hypertensive patients not adequately responsive to olmesartan
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients with mild to moderate hypertension, untreated or currently taking
             antihypertensive therapy

          -  treated patients (using antihypertensive drugs within 4 weeks prior to first visit)
             must have an office msSBP ≥ 145 mmHg and < 180 mmHg after washout epoch and after 4
             weeks run-in epoch

          -  untreated patients (either newly diagnosed or those patients with a history of
             hypertension but have not been taking any antihypertensive drugs for at least 4 weeks
             prior to first visit) must have an offcie msSBP ≥ 150 mmHg and < 180 mmHg at screening
             and 1 week after screening and must have an office msSBP ≥ 145 mmHg and < 180 mmHg
             after 4 weeks run-in epoch

          -  patients must successfully complete ABPM and pass technical requirements to be
             qualified for randomization

        Exclusion Criteria:

          -  Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg
             and/or msSBP ≥ 180 mmHg)

          -  History of angioedema, drug-related or otherwise

          -  History or evidence of a secondary form of hypertension, including but not limited to
             any of the following: renal parenchymal hypertension, renovascular hypertension
             (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary
             hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease
             (PKD), drug-induced hypertension

          -  Patients who previously entered a LCZ696 study and had been randomized or enrolled to
             receive active drug treatment
Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis
Condition: Refractory Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: Eculizumab; Placebo
Intervention description: Intravenous administration of eculizumab.; Intravenous administration of matching placebo. Participants received placebo only during the Blind Induction Phase.
Intervention MeSH terms: Eculizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Following the Blind Induction Phase, all participants received open-label eculizumab.
Masking: None (Open Label)
Masking description: The study consisted of a 4-week Blind Induction Phase to preserve the blinded nature of Study ECU-MG-301, followed by an Open-Label Maintenance Phase.
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: gMG; Myasthenia Gravis; safety; efficacy

Summary:

      To evaluate the safety and efficacy of eculizumab in the treatment of refractory generalized
      myasthenia gravis (gMG) as an extension study for the participants who previously completed
      Study ECU-MG-301(NCT01997229).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant has completed Study ECU-MG-301.

          2. Participant has given written informed consent.

          3. Participant was willing and able to comply with the protocol requirements for the
             duration of the study.

          4. Female participant of childbearing potential must have had a negative pregnancy test
             (serum human chorionic gonadotropin). All participants were required to practice an
             effective, reliable, and medically approved contraceptive regimen during the study and
             for up to 5 months following discontinuation of treatment.

        Exclusion Criteria:

          1. Participants who withdrew from Study ECU-MG-301 as a result of an adverse event
             related to study drug.

          2. Female participants who were pregnant, breastfeeding, or intended to conceive during
             the course of the study.

          3. Unresolved meningococcal infection

          4. Hypersensitivity to murine proteins or to one of the excipients of eculizumab

          5. Any medical condition or circumstances that, in the opinion of the investigator, might
             have interfered with the participant's participation in the study, posed any added
             risk for the participant, or confounded the assessment of the participants.
A Multi-Center, Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: AC-170 0.24%; AC-170 0%
Intervention description: 1 drop in each eye at 2 separate times during a 14 day period; 1 drop in each eye at 2 separate times during a 14 day period
Intervention MeSH terms: Cetirizine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 101.0
Sex: All
Minimum age: 10 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24%
      compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in
      the conjunctival allergen challenge (CAC) model.
    

Eligibility criteria:

        Inclusion Criteria:

          -  positive bilateral conjunctival allergen challenge (CAC) reaction

        Exclusion Criteria:

          -  known contraindications or sensitivities to the study medication or its components

          -  any ocular condition that, in the opinion of the investigator, could affect the
             subjects safety trial parameters

          -  use of disallowed medication during the period indicated prior to the enrollment or
             during the study
Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Intervention: Daclatasvir; Sofosbuvir; Ribavirin
Intervention MeSH terms: Ribavirin; Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and
      Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic
      Hepatitis C (HCV) in patients with advanced fibrosis or compensated cirrhosis. Patients in
      this study may have already been treated prior for HCV or may have never received treatment
      for their HCV.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Must have Genotype 3 Chronic HCV

          -  Must have advanced fibrosis (F3) or compensated cirrhosis (F4)

          -  HCV RNA Viral load ≥ 10,000 IU/mL

          -  HCV Treatment naive or treatment-experienced

        Exclusion Criteria:

          -  Non Genotype 3 or mixed genotypes

          -  Non advanced fibrosis or compensated cirrhosis

          -  Any prior treatment with NS5A inhibitors