bioihbjkbjnl/mcl2 huggingface dataset:
A Twelve Week, Open Label Extension Study in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Lurasidone
Intervention description: Lurasidone 40-80 mg taken orally taken once daily
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 191.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lurasidone; Latuda; Schizophrenia

Summary:

      This is a 12-week, multi-center, open-label extension study designed to evaluate the
      longer-term safety, tolerability and effectiveness of lurasidone for the treatment of
      subjects with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has agreed to participate by providing written informed consent.

          -  Subject will be eligible to participate if one of the following criteria is met:

          -  Subject has completed the 28-week double-blind phase of study D1050238

          -  Subject has experienced a protocol-defined relapse event during the double- blind
             phase in study D1050238

          -  Subject is participating in the open-label or double-blind phase of study D1050238
             if/when study D1050238 is terminated by the sponsor.

          -  Subject has completed all required assessments on the final study visit (Study Visit
             Number 42) in study D1050238.

          -  Subject is judged by the Investigator to be suitable for participation in a 12-week
             clinical trial involving open-label lurasidone treatment and is able to comply with
             the protocol in the opinion of the Investigator.

        Exclusion Criteria:

          -  Subject is considered by the investigator to be at imminent risk of suicide or injury
             to self, others, or property.

          -  Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with
             some intent to act, without specific plan) or item 5 (active suicidal ideation with
             specific plan and intent) on the C-SSRS at the extension baseline visit (Study Visit
             Number 42 in study D1050238). Subjects who answer "yes" to this question must be
             referred by the Investigator for appropriate follow-up evaluation and treatment.

          -  Subject tests positive for drugs of abuse or is suspected of current alcohol abuse at
             the extension baseline visit (Study Visit Number 42 in study D1050238). In the event a
             subject tests positive for cannabinoids, the Investigator will evaluate the subject's
             ability to abstain from cannabis during the study.
Hydrocortisone for BPD
Condition: Infant, Newborn; Infant, Small for Gestational Age; Infant, Very Low Birth Weight; Infant, Premature; Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia; Birth Weight
Intervention: Hydrocortisone; Placebo
Intervention description: Hydrocortisone sodium succinate for intravenous administration (unpreserved, Solu-Cortef plain, Pfizer®, reconstituted with unpreserved normal saline to avoid exposure to the benzyl alcohol contained in preserved diluents), to be administered either intravenously or orally if no intravenous line is available at the same dose, and tapered as follows:
4mg/kg/day ¸ q 6 hours x 2 days, then 2mg/kg/day ¸ q 6 hours x 3 days; then
1mg/kg/day ¸ q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days; Saline placebo to be administered either intravenously or orally if no intravenous line is available, at the same dose, and tapered as follows:
4mg/kg/day ¸ q 6 hours x 2 days, then 2mg/kg/day ¸ q 6 hours x 3 days; then
1mg/kg/day ¸ q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days
Intervention MeSH terms: Hydrocortisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 800.0
Sex: All
Maximum age: 30 Weeks
Healthy volunteers: No
Keywords: NICHD Neonatal Research Network; Extremely Low Birth Weight (ELBW); Very Low Birth Weight (VLBW); Prematurity; Mechanical ventilation; Intubation; Neurodevelopmental impairment

Summary:

      The Hydrocortisone and Extubation study will test the safety and efficacy of a 10 day course
      of hydrocortisone for infants who are less than 30 weeks estimated gestational age and who
      are intubated at 14-28 days of life. Infants will be randomized to receive hydrocortisone or
      placebo. This study will determine if hydrocortisone improves infants'survival without
      moderate or severe BPD and will be associated with improvement in survival without moderate
      or severe neurodevelopmental impairment at 22 - 26 months corrected age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  infants <30 weeks estimated gestational age

          -  inborn at an NRN site or were admitted to an NRN site before 72 hours postnatal age

          -  have received at least 7days of mechanical ventilation;

          -  are receiving mechanical ventilation through an endotracheal tube .

        Exclusion Criteria:

          -  Major congenital anomalies

          -  Decision to limit support

          -  Indomethacin or ibuprofen treatment within 48 hours of study drug

          -  Previous corticosteroid treatment for BPD

          -  Received hydrocortisone for 14 or more cumulative days

          -  Received hydrocortisone within 7 days of study entry
Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Certolizumab pegol
Intervention description: Subcutaneous (SC) injection
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 208.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Certolizumab Pegol; Cimzia

Summary:

      The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol
      when administered without coadministration of methotrexate over the long term in Japanese RA
      patients who transferred from Study 275-08-003 (NCT00791921), and to evaluate the effects of
      different dosing regimens on the safety and efficacy of certolizumab pegol in American
      College of Rheumatology 20% (ACR20) responders who completed Study 275-08-003.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who participated in Study 275-08-003 and meet all of the criteria described
             below.

               -  Patients who did not reach ACR20, and prematurely discontinued Study 275-08-003
                  at Week 16 or completed Study 275-08-003 by Week 24.

        Exclusion Criteria:

          -  Patients who experienced an important protocol deviation as mentioned below during
             Study 275-08-003.

          -  Patients who received live or attenuated vaccines during Study 275-08-003 (Except for
             influenza or pneumococcal vaccines).

          -  Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-003.

          -  Patients who required treatment for the same infection at two or more different times
             during Study 275-08-003

          -  Women who are pregnant, are lactating, of childbearing potential and wish to conceive
             during the study and post-study 3 months.

          -  Patients whom the investigator has decided to be inappropriate for participation in
             the study
Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial
Condition: Cerebrovascular Disorders; Hemiplegia
MeSH terms: Hemiplegia; Cerebrovascular Disorders
Intervention: Robot-Low; Robot-High; Control
Intervention description: 1 hour/day of robot-assisted upper limb exercise therapy in addition to usual physical and occupational therapy; 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy; 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 71.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Rehabilitation; Robotics

Summary:

      The purpose of this study is to compare the effectiveness of a lower-dose and higher-dose
      therapy program for persons recovering from a recent stroke using mechanically-assisted upper
      limb movement with a device called MIME. A control group receives additional occupational
      therapy without the use of MIME.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Over 21 years of age, weakness due to a recent stroke or other brain injury, and
             receiving rehabilitation. Subjects are inpatients at one of the participating VA
             hospitals.

        Exclusion Criteria:

        Unable to follow instructions; medically unstable.
Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: PF-04965842 100 mg; PF-04965842 200 mg; Placebo
Intervention description: PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks; PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks; Placebo, administered as two tablets to be taken orally once daily for 12 weeks
Intervention MeSH terms: Abrocitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 387.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: atopic dermatitis; atopic eczema; eczema; JAK; janus kinase

Summary:

      B7451012 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with
      a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy
      and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily,
      will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients
      will have an option to enter a long-term extension study after completing 12 weeks of
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  12 years of age or older with a minimum body weight of 40 kg

          -  Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate
             to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS 4)

          -  Recent history of inadequate response or inability to tolerate topical AD treatments
             or require systemic treatments for AD control

        Exclusion Criteria:

          -  Unwilling to discontinue current AD medications prior to the study or require
             treatment with prohibited medications during the study

          -  Prior treatment with JAK inhibitors

          -  Other active nonAD inflammatory skin diseases or conditions affecting skin

          -  Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q
             wave interval abnormalities, current or history of certain infections, cancer,
             lymphoproliferative disorders and other medical conditions at the discretion of the
             investigator

          -  Pregnant or breastfeeding women, or women of childbearing potential who are unwilling
             to use contraception
Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: SOF; RBV; Placebo to match SOF; Placebo to match RBV
Intervention description: Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Ribavirin (RBV) was administered as a tablet orally according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).; Placebo to match SOF was administered orally once daily.; Placebo to match RBV was administered orally twice daily.
Intervention MeSH terms: Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 278.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HCV genotype 2 (GT-2); HCV genotype 3 (GT-3); HCV; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; Interferon intolerant; Interferon ineligible; GS-7977; Ribavirin

Summary:

      This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection
      who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants
      were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to
      match SOF+placebo to match RBV. Randomization was stratified by presence/absence of
      cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infection with HCV genotype 2 or 3

          -  Cirrhosis determination

          -  Subject meets one of the following classifications:

               1. IFN unwilling

               2. IFN ineligible

               3. IFN intolerant

          -  Screening laboratory values within defined thresholds

          -  Subject has not been treated with any investigational drug or device within 30 days of
             the Screening visit

          -  Use of highly effective contraception methods if female of childbearing potential or
             sexually active male

        Exclusion Criteria:

          -  Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein
             (NS)5B polymerase

          -  Pregnant or nursing female or male with pregnant female partner

          -  Current or prior history of clinical hepatic decompensation

          -  History of clinically-significant illness or any other major medical disorder that may
             interfere with subject treatment, assessment or compliance with the protocol

          -  Excessive alcohol ingestion or significant drug abuse
Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Fulvestrant; Anastrozole
Intervention description: intramuscular injection 250 mg loading dose (LD) regimen; 1 mg oral tablet
Intervention MeSH terms: Fulvestrant; Anastrozole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 514.0
Sex: Female
Healthy volunteers: No
Keywords: Hormone; receptor; positive; breast; cancer; first; relapse

Summary:

      The purpose of this study is to determine the efficacy of anastrozole monotherapy versus
      maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared
      with in treatment of hormone receptor positive women with first relapse of breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent, postmenopausal females, histological or cytological confirmed
             oestrogene and/or progesterone (PgR) receptor positive breast cancer, local recurrence
             or metastasis

        Exclusion Criteria:

          -  Previous systemic endocrine therapy for advanced or recurrent disease; prior
             fulvestrant therapy

          -  Premenopausal women
Left Ventricular Hypertrophy Reduction With Statins in Hypertensives Patients (MK0653A-168)
Condition: Hypertension
MeSH terms: Hypertrophy, Left Ventricular; Hypertrophy
Intervention: valsartan; pravastatin; simvastatin; ezetimibe (+) simvastatin
Intervention description: 80 mg valsartan. Duration: 12 months. Tablets; 40 mg pravastatin. Duration: 12 months. Tablets; 40 mg simvastatin. Duration: 12 months. Tablets; ezetimibe (+) simvastatin 10/40 mg. Duration: 12 months. Tablets
Intervention MeSH terms: Valsartan; Simvastatin; Ezetimibe; Pravastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Evaluate pleiotropic effects of simvastatin in hypertensive patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females Or Males Over 18 Years Old

          -  Patients With Systemic Arterial Hypertension Grade I And II According With The
             European Society Of Cardiology

          -  Left Ventricular hypertrophy Demonstrated By Echocardiography

          -  Mild To Moderated hypercholesterolemia

          -  Willing To Participate And Sign The Informed Consent Form (ICF)

        Exclusion Criteria:

          -  Type 1 Or 2 Diabetes Mellitus

          -  Familiar hypercholesterolemia

          -  Low Density Lipoprotein-Cholesterol (LDL-C) > 190 mg/dl

          -  History Of Myocardial Infarction Or Stable Chronic Angina

          -  Triglycerides >250 mg/dl
Effect of Liraglutide in Combination With Sulfonylurea (SU) on Blood Glucose Control in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sulfonylurea; liraglutide; liraglutide
Intervention description: SU agent; Liraglutide 0.6 mg/day or placebo. Injected s.c. (under the skin) once daily.; Liraglutide 0.9 mg/day or placebo. Injected s.c. (under the skin) once daily.
Intervention MeSH terms: Liraglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 264.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Japan. The trial aims for comparison of the effect on glycaemic
      control of liraglutide in combination with sulphonylurea agent (SU) compared to SU
      monotherapy, as assessed by HbA1c after 24 weeks and 52 weeks in subjects with type 2
      diabetes. Liraglutide will be compared to placebo, in combination with SU. Trial has a
      randomisation period of 24 weeks followed by a 28 week extension period, in total 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Diet/exercise therapy with sulfonylurea (SU) for at least eight weeks

          -  HbA1c greater than or equal to 7.0% and less than 10.0%

          -  BMI less than 35 kg/m2

        Exclusion Criteria:

          -  Treatment with insulin within the last 12 weeks

          -  Treatment with any drug that could interfere with the glucose level

          -  Any serious medical condition

          -  Females who are pregnant, have intention of becoming pregnant or are breastfeeding
Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
Condition: Cancer; Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Ixabepilone + Capecitabine; Capecitabine
Intervention description: Ixabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle; Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle
Intervention MeSH terms: Capecitabine; Epothilones
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1221.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to learn if BMS-247550 added to the approved
      therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine
      alone in women with metastatic breast cancer. Patients should have previously received an
      anthracycline and a taxane. The safety of this treatment will also be studied.
    

Eligibility criteria:

        -  Patients must have received prior treatment which included both an anthracycline
             (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).

          -  Patients must have received no more than two prior chemotherapy regimens. Patients who
             have not received treatment for metastatic disease must have relapsed within one year.

          -  Patients may not have any history of brain and/or leptomeningeal metastases.

          -  Patients may not have Grade 2 or worse neuropathy at the time of study entry.

          -  Patients may not have had prior treatment with any epothilones and/or capecitabine
             (i.e. Xeloda)
Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection
Condition: Hepatitis C
MeSH terms: Hepatitis C
Intervention: SOF; RBV
Intervention description: Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Ribavirin (RBV) tablets administered orally in a divided daily dose using weight-based dosing (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir plus
      ribavirin administered for 16 weeks and 24 weeks in participants with chronic genotype 1
      (GT1) or genotype 3 (GT3) hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed chronic genotype 1 or 3 HCV infection

          -  HCV treatment-naive

          -  Individuals will have cirrhosis status assessment; liver biopsy may be required.

          -  Screening laboratory values within predefined thresholds

          -  Use of two effective contraception methods if female of childbearing potential or
             sexually active male

        Exclusion Criteria:

          -  Pregnant or nursing female or male with pregnant female partner

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

          -  Contraindication to ribavirin therapy

          -  Excessive alcohol ingestion as defined by protocol

          -  History of solid organ transplantation

          -  Current or prior history of clinical hepatic decompensation

          -  History of clinically significant illness or any other medical disorder that may
             interfere with the individual's treatment, assessment, or compliance with the protocol