bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: LDX 30 mg; LDX 50 mg; LDX 70 mg; Placebo
Intervention description: Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.; Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.; Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind.; Placebo will be identical to test product.
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 314.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The study will evaluate the efficacy of LDX treatment group compared to placebo on the change
      from Baseline ADHD-RS-IV score at endpoint.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet DSM-IV-TR criteria for a primary diagnosis of ADHD

          -  Baseline ADHD-RS-IV score >=28

          -  BP w/in 95th percentile for age, gender, and height

        Exclusion Criteria:

          -  Subject has controlled or uncontrolled comorbid psychiatric diagnosis

          -  Subject has conduct disorder

          -  Suicidal

          -  Under or overweight

          -  Concurrent chronic or acute illness that might confound results.
Usefulness of BiClamp Forceps for Liver Resection: A Randomized Clinical Trial
Condition: Hepatobiliary Disease
MeSH terms: Digestive System Diseases; Liver Diseases
Intervention: Clamp-Crushing technique; BiClamp forceps
Intervention description: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps; liver transection during hepatectomy by BiClamp forceps
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: BiClamp forceps hepatectomy; Clamp crushing technique; Liver parenchyma transection; Randomized controlled trial

Summary:

      The purpose of this study is to compare short-term and long-term efficacy of BiClamp forceps
      hepatectomy and clamp-crushing technique for parenchymal transection during elective hepatic
      resection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Both male and female, aged 18 or older

          -  Patients scheduled to undergo hepatic resection for some benign or malignant
             hepatobiliary disease

          -  Child-Pugh class A or B liver function

          -  BiClamp forceps hepatectomy and clamp-crushing feasible based on preoperative imaging

          -  No tumor invasion the main vein, hepatic artery and vein and major inferior vena cava

          -  No extrahepatic metastasis

          -  Voluntary participation in the study, and informed consent.

        Exclusion Criteria:

          -  Age <18 years or> 65 years , pregnant or lactating women

          -  Preoperative liver function evaluation: Child-Pugh C grade

          -  Laparoscopic hepatectomy

          -  Extrahepatic metastasis

          -  Tumor invasion the main vein, hepatic artery and vein and major inferior vena cava

          -  The patient refused to sign the informed consent form
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia; Hyperplasia
Intervention: Inhaled Nitric Oxide; Placebo
Intervention description: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.; Nitrogen gas will be administered in the same manner as the experimental drug.
Intervention MeSH terms: Nitric Oxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 451.0
Sex: All
Minimum age: 5 Days
Maximum age: 14 Days
Healthy volunteers: No
Keywords: Bronchopulmonary Dysplasia, BPD

Summary:

      This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will
      attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive
      pressure support at any point during days 5 to 14 after birth may benefit from treatment with
      iNO.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Preterm infants who are:

               1. 500 to 1250 grams at birth

               2. < 30 weeks gestational age

               3. 5 to 14 days of age (inclusive) at the time of entry

               4. Requiring mechanical ventilation or for those infants ≤ 800 grams, positive
                  pressure support (including CPAP) for respiratory insufficiency on days 5 to 14
                  days of age (inclusive)

        Exclusion Criteria:

          1. Preterm infants with life-threatening anomalies (cranial, cardiac, thoracic,
             chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any subject
             who will not receive complete intensive care

          2. Preterm infants with bilateral Grade 4 intraventricular hemorrhage (IVH)

          3. Subjects who are dependent on right to left shunting to maintain the systemic
             circulation

          4. Preterm infants who received prior iNO therapy

          5. Use of another investigational agent
Comparing Two Pneumococcal Vaccines in Adults With Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Pneumovax (PPSV23); Prevnar (PCV7)
Intervention description: Injection; Injection
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 181.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Chronic Obstructive Pulmonary Disease; COPD; Pneumococcal; Vaccine; Opsonization; Antibodies

Summary:

      Pneumococcal disease is a serious bacterial infection that can affect different parts of the
      body, including the lungs. People with chronic illnesses, such as chronic obstructive
      pulmonary disease (COPD), have a greater risk of developing pneumonia and meningitis as a
      result of pneumococcal disease. This study will compare the immune response to two types of
      pneumococcal vaccines in adults with COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)

          -  Post-bronchodilator forced expiratory volume at one second

             /forced vital capacity (FEV1/FVC) level less than 70%

          -  Ten or more pack-years of smoking

          -  Willing to make return visits to the study clinic and accept telephone contact

          -  Last pneumococcal vaccination occured at least 5 years prior to study entry

        Exclusion Criteria:

          -  Asthma

          -  Sensitivity to pneumococcal vaccine

          -  Known bleeding disorder, or requires long-term anticoagulation therapy

          -  Presence of chronic disease that may impair pneumococcal vaccine response

          -  Acute illness requiring antibiotics in the month prior to study entry

          -  Medical condition that makes survival for 24 months following study entry unlikely

          -  Pregnant
SleepSure: A Trial to Assess the Effects of Eye Masks and Earplugs on Hospital Inpatient Sleep
Condition: Sleep
Intervention: Ear plugs; Eye Mask; Zopiclone
Intervention description: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.; The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.; This night sedation will be given to any patient requesting it, in either group
Intervention MeSH terms: Zopiclone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, investigator-blinded, parallel group design
Masking: Single (Investigator)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: falls; sleep

Summary:

      The aim of this study is to determine whether routinely providing patients admitted to
      hospital with two devices to help sleep - ear plugs, and an eyeshade - leads to patients
      having a better quality of sleep and/or longer, more satisfying sleep.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be 18 years of age.

          -  Be expected to stay in Oxford University Hospitals National Health Service (NHS)
             Foundation Trust for at least one night.

          -  Be able to understand and use earplugs and eye mask.

          -  Have basic understanding of English reading and writing.

          -  Be considered likely to have the Mental Capacity to give consent for use of personal
             data in the study at the point of filling in the SleepSure Questionnaire (time of
             discharge). Data will not be collected from individuals who are unable to give consent
             with the filling in of the SleepSure questionnaire.

          -  Be expected to be able to fill in the SleepSure Questionnaire at the point of
             discharge with or without assistance.

        Exclusion Criteria:

          -  They have or are expected to have an obvious medical contra-indication to the use of
             earplugs and eye mask at the point of enrollment e.g. eye infection, as per clinical
             judgement of recruiter.

          -  They are unlikely to benefit from the intervention in the judgement of the recruiter
             (i.e. individuals who are deaf and blind).
A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation
Condition: Cystic Fibrosis, Homozygous for the F508del CFTR Mutation
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Lumacaftor Plus Ivacaftor Combination; Ivacaftor; Placebo
Intervention description: Fixed dose combination tablet; Film-coated tablet; Matching placebo tablet
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 559.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to evaluate the efficacy of lumacaftor in combination
      with ivacaftor at Week 24 in participants aged 12 years and older with cystic fibrosis (CF)
      who are homozygous for the F508del mutation on the CF transmembrane conductance regulator
      (CFTR) gene.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of CF

          -  Homozygous for the F508del CFTR mutation

          -  Forced expiratory volume in 1 second (FEV1) greater than or equal to (>=) 40 percent
             (%) and less than or equal to (=<) 90% of predicted normal for age, sex, and height

          -  Willing to remain on a stable CF medication regimen through Week 24 or, if applicable,
             the Safety Follow up Visit

        Exclusion Criteria:

          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
             therapy (including antibiotics) for pulmonary disease within 4 weeks before first dose
             of study drug

          -  History of solid organ or hematological transplantation

          -  History of alcohol or drug abuse in the past year

          -  Ongoing or prior participation in an investigational drug study (including studies
             investigating lumacaftor and/or ivacaftor) within 30 days of screening

          -  Use of strong inhibitors, moderate inducers or strong inducers of Cytochrome P450 3A
             (CYP3A) within 14 days before Day 1 of dosing
Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination in Treatment-Naïve Hepatitis C Virus Participants (MK-5172-067)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Grazoprevir/Elbasvir; Placebo
Intervention description: FDC tablet containing 100 mg of grazoprevir and 50 mg of elbasvir taken q.d. by mouth for 12 weeks.; Placebo tablet matching grazoprevir/elbasvir FDC tablet taken q.d. by mouth for 12 weeks.
Intervention MeSH terms: Grazoprevir; Elbasvir-grazoprevir drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 489.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, parallel-group, placebo-controlled, multi-site, multinational,
      double-blind followed by open label period, Phase 3 trial of 100 mg of grazoprevir (MK-5172)
      in combination with 50 mg of elbasvir (MK-8742) (grazoprevir/elbasvir fixed-dose combination
      [FDC]) in treatment-naïve (TN) participants with chronic hepatitis C virus (HCV), genotype
      (GT) 1, 4 or 6 infection. The primary hypothesis is that the percentage of participants
      receiving grazoprevir/elbasvir FDC in the Immediate Treatment Group (ITG) achieving Sustained
      Virologic Response 12 weeks after the end of all study therapy (SVR12) will be superior to
      the historical reference rate of 73%.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has documented chronic HCV GT1, GT4, or GT6 (with no evidence of non-typeable or mixed
             genotype) infection

          -  Meets clinical criteria for presence or absence of cirrhosis based on liver disease
             staging assessment

          -  Is abstinent or uses acceptable method(s) of contraception

        Exclusion Criteria:

          -  Has evidence of decompensated liver disease

          -  Is coinfected with hepatitis B virus or human immunodeficiency virus (HIV)

          -  Shows evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC

          -  Has a clinically-relevant drug or alcohol abuse within 12 months of screening

          -  Is pregnant or breast-feeding

          -  Has any condition or abnormality that might confound the results of the trial or pose
             an additional risk to the participant
Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol 300 µg; Salmeterol 50 µg
Intervention description: Indacaterol 300 µg once daily (od) via SDDPI; Salmeterol 50 µg twice daily (bid) via Diskus®
Intervention MeSH terms: Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 186.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD, Chronic Obstructive Pulmonary Disease, Indacaterol, long acting β2-agonist

Summary:

      This study is designed to collect long term safety data of indacaterol (300 µg o.d.) in
      Japanese patients with moderate to severe COPD. Data from this study will be used for the
      registration of indacaterol in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic
        Obstructive Lung Disease (GOLD) Guidelines) and:

          -  Smoking history of at least 20 pack-years

          -  Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value

          -  Post-bronchodilator FEV1/FVC (forced vital capacity) <70%

        Exclusion Criteria:

          1. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to
             Visit 1 or during the run-in period

          2. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1

          3. Patients with concomitant pulmonary disease

          4. Patients with a history of asthma

          5. Patients with diabetes Type I or uncontrolled diabetes Type II

          6. Any patient with lung cancer or a history of lung cancer

          7. Patients with a history of certain cardiovascular comorbid conditions

          8. Patients who have been exposed to indacaterol previously. (Except for any patient who
             enrolled in Study CQAB149B1302)

        Other protocol-defined inclusion/exclusion criteria may apply
Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: adalimumab
Intervention description: 40 mg eow, sc
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 309.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Rheumatoid arthritis

Summary:

      The purpose of the study is to assess the long-term safety and tolerability of repeated
      administration of adalimumab in Japanese subjects with rheumatoid arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participation and completion until Week 24 of the prior adalimumab dose-ranging study.

          -  Females must be postmenopausal for at least 1 year, surgically sterile, or practicing
             birth control throughout the study and for 90 days after study completion.

          -  Female subjects tested negative in pregnancy test (serum test) at Week 24 in prior
             adalimumab study, if capable of pregnancy.

        Exclusion Criteria:

          -  A subject who experienced any of the following during prior study:

               -  Advanced or poorly controlled diabetes

               -  Joint surgery (joint evaluated in this study)

          -  A subject who has been prescribed excluded medications during prior study.

          -  History of following during prior study:

               -  Clinically significant drug or alcohol abuse

               -  Intravenous (iv) drug abuse

               -  Active infection with listeria or tuberculosis (TB)

               -  Lymphoma, leukemia

               -  And, any malignancy with the exception of successfully treated non-metastatic
                  basal cell carcinoma of the skin.

          -  A subject who has been administered a live vaccine during prior study, or subject
             scheduled to complete the administration of a live vaccine during the study period
An Investigational Immuno-therapy Study of Nivolumab Compared to Sorafenib as a First Treatment in Patients With Advanced Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Nivolumab; Sorafenib
Intervention description: Specified Dose on Specified Days; Specified Dose on Specified Days
Intervention MeSH terms: Nivolumab; Sorafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 743.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if nivolumab or sorafenib is more effective in the
      treatment of Advanced Hepatocellular Carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed advanced hepatocellular carcinoma, not eligible for surgical
             and/or locoregional therapies; or progressive disease after surgical and /or
             locoregional therapies

          -  Locoregional therapy for hepatocellular carcinoma (HCC) must be completed at least 4
             weeks prior to the baseline scan

          -  Child-Pugh Class A

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

        Exclusion Criteria:

          -  Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC

          -  Prior liver transplant

          -  Active, known, or suspected autoimmune disease

        Other protocol-defined inclusion/exclusion criteria apply