bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Study of Daytrana TM in Children With Autism Co-Morbid for Attention Deficit Hyperactivity Disorder (ADHD) Symptoms
Condition: Autism; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Autistic Disorder; Attention Deficit Disorder with Hyperactivity
Intervention: Methylphenidate Transdermal System
Intervention description: 10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage
Intervention MeSH terms: Methylphenidate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Autism; Autism Spectrum Disorders; ADHD

Summary:

      This is an open-label study of the efficacy of Daytrana (methylphenidate transdermal system)
      for the treatment of attention and behavioral symptoms in children with Autism Spectrum
      Disorders. Twenty patients will be enrolled and treated with 10-30 mg of Daytrana for a total
      of eight weeks. Changes in core hyperactivity, impulsivity, and inattention symptoms, autism
      spectrum symptoms and functional outcomes will be assessed. Acceptability of the transdermal
      route of administration in this population will also be assessed.

      The researchers hypothesize that Daytrana is a safe and effective medication for children
      with Autism Spectrum Disorders who have symptoms of inattention, hyperactivity and
      impulsivity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 6 and 11 years

          -  Autism Spectrum Disorder

          -  Attention Deficit Hyperactivity Disorder

          -  Stimulant medication-free at study entry

          -  No clinically significant abnormalities that preclude safe participation

          -  Sufficient developmental level (~3 yrs)

          -  Able to keep appointments

          -  Able to communicate effectively

          -  Teacher cooperation

        Exclusion Criteria:

          -  Received an investigational medication in the previous 30 days

          -  Current medication treatment is effective and well-tolerated

          -  Medical conditions that affect patient safety

          -  MAOIs within one month

          -  Hypertension

          -  Bipolar disorder or psychosis

          -  Anticonvulsants

          -  Psychotropic medication or health food supplement

          -  Tourette Disorder

          -  Seizure disorder

          -  Neurological condition

          -  Structural heart disease
Patient Narcotic Requirements After Outpatient Otolaryngology Procedures
Condition: Outpatient Surgery; Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Norco; Ibuprofen
Intervention description: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control; Ibuprofen as first line therapy every 6 hours as needed for pain control
Intervention MeSH terms: Acetaminophen; Ibuprofen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Narcotics
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized to one of two groups prior to surgery. All patients will be prescribed both Hydrocodone/acetaminophen and Ibuprofen. Group 1 will take the narcotic medication for initial pain control followed by Ibuprofen if pain is not adequately controlled. Group 2 will take Ibuprofen for initial pain control followed by the narcotic medication if pain is not adequately controlled.
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Thyroidectomy; Parotidectomy; Tympanoplasty; Mastoidectomy; Septoplasty; Sinus Surgery; Postoperative pain; Outpatient surgery

Summary:

      Patient's pain level and narcotic requirements will be evaluated after routine outpatient
      Otolaryngology procedures. This will be done by having study participants record their pain
      level and medication usage from home.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients undergoing one of the following outpatient procedure:

          -  Septoplasty

          -  Unilateral or Bilateral Functional endoscopic sinus surgery

          -  Tympanomastoidectomy

          -  Tympanoplasty

          -  Total or Partial Thyroidectomy

          -  Parathyroidectomy

          -  Parotidectomy.

          -  Age >18 years and < 89 years

        Exclusion Criteria:

          -  Age < 18 years or > 89 years

          -  Post operative hospital admission

          -  Allergy to Hydrocodone

          -  Allergy or contraindication to Ibuprofen or NSAIDs

          -  Pregnancy

          -  Hepatic disease

          -  Chronic kidney disease

          -  Sickle cell anemia
A Long Term Extension Study of E2080 in Lennox-Gastaut Patients
Condition: Lennox-Gastaut Syndrome
MeSH terms: Lennox Gastaut Syndrome
Intervention: Rufinamide
Intervention description: The target dosage is approximately 45 mg/kg/day, taken orally twice a day.
Intervention MeSH terms: Rufinamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 4 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Epilepsy; Seizures

Summary:

      To investigate the safety of long term administration of E2080 in the patients with
      Lennox-Gastaut syndrome who completed the E2080-J081-304 Study.
    

Eligibility criteria:

        Inclusion criteria:

          1. Participants who have completed the evaluation of Week 12 of the E2080-J081-304 study.

          2. Male participants with reproductive ability and female participants with child-bearing
             potential, or their partners, had to be able to take medically appropriate
             contraceptive measures.

          3. Participants who have provided a written informed consent to participate in this
             clinical trial until the evaluation of week 12 of the E2080-J081-304 study.

          4. Participants who had a family member or a caregiver capable of recording the reporting
             diary, providing participant information necessary for the study, assisting treatment
             compliance, and accompanying the participant on scheduled visit days during the study
             period.

        Exclusion criteria:

          1. Participants who were judged by the investigator that they are unfit to participate in
             this clinical study for safety reasons based on the information up to the evaluation
             of week 12 of the E2080-J081-304 Study.

          2. Participants who were judged by the investigator that they are likely to become
             non-compliant with administration during the clinical trial period.

          3. Participants who were judged by the investigator that they were unfit to participate
             in this clinical trial.
Study of BMS-477118 as Monotherapy With Titration in Subjects With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Intervention: Saxagliptin; Saxagliptin; Saxagliptin; Saxagliptin; Placebo; metformin
Intervention description: Coated tablets, Oral, 2.5 mg, QAM, Daily (6 months ST, 12 months LT); Coated tablets, Oral, 2.5 mg titrated to 5mg, QAM, Daily (6 months ST, 12 months LT); Coated tablets, Oral, 5mg, QAM, Daily, (6 months ST, 12 months LT); Coated tablets, Oral, 5mg QPM, Daily (6 months ST, 12 months LT); Coated tablets, Oral, 0mg, Daily (6 months ST, 12 months LT); Tablets, Oral, 500-2000 mg, as needed (12 months LT)
Intervention MeSH terms: Metformin; Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 365.0
Sex: All
Minimum age: 18 Years
Maximum age: 77 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to understand if saxagliptin is more effective than placebo as a
      treatment for type 2 diabetic subjects who are not controlled with diet and exercise
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Inadequate blood sugar control

        Exclusion Criteria:

          -  Previous treatment for diabetes

          -  Current treatment with other medications to lower blood sugar

          -  Major heart, liver or kidney problems

          -  Women who are pregnant or breastfeeding
Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers
Condition: Non-squamous Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Paclitaxel; Carboplatin; Cisplatin; Veliparib; Pemetrexed
Intervention description: Administered by Intravenous infusion on Day 1 of each 21-day cycle; Administered by Intravenous infusion on Day 1 of each 21-day cycle; Administered by Intravenous infusion on Day 1 of each 21-day cycle; Oral capsule, administered twice daily for 7 days in each 21-day cycle; Administered by Intravenous infusion on Day 1 of each 21-day cycle
Intervention MeSH terms: Paclitaxel; Carboplatin; Pemetrexed; Veliparib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 595.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: veliparib; carboplatin; paclitaxel; cisplatin; pemetrexed; Poly Adenosine diphosphate (ADP)-ribose Polymerase (PARP); Metastatic; Non-squamous; Non-small cell lung cancer

Summary:

      The purpose of this study is to evaluate the safety and efficacy of veliparib plus
      carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in
      adults with metastatic or advanced non-squamous non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be ≥ 18 years of age with life expectancy > 12 weeks.

          -  Subject must have cytologically or histologically confirmed advanced or metastatic
             non-squamous NSCLC and are current or former smokers.

          -  Subject must have NSCLC that is not amenable to surgical resection or radiation with
             curative intent at time of screening.

          -  Subject must have at least 1 unidimensional measurable NSCLC lesion on a computed
             tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors
             (RECIST) version 1.1.

        Exclusion Criteria:

          -  Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with
             polyethoxylated castor oil (Cremophor).

          -  Subject has a known hypersensitivity to platinum compounds.

          -  Subject has peripheral neuropathy ≥ grade 2.

          -  Subject has squamous NSCLC, or an untreated known epidermal growth factor receptor
             (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21, or a known
             anaplastic lymphoma kinase (ALK) gene rearrangement.

          -  Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC.
The Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
Condition: Opioid-Induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: CB-5945; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Opioid; Constipation; Chronic; Pain

Summary:

      The purpose of this study is to evaluate the safety and efficacy of CB-5945 for the treatment
      of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer
      pain.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Is taking a stable daily dose of opioids of ≥ 30 mg morphine equivalent total daily
             dose (METDD) for chronic non-cancer pain

          -  Has constipation that is caused by the chronic use of opioids

          -  Is willing to use only the study provided laxative(s) and to discontinue use of all
             other laxatives, enemas, stool softeners, and other medications to treat constipation
             (e.g., lubiprostone) from Screening until the last study assessment

        Key Exclusion Criteria:

          -  Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for
             example [e.g.], obstruction) or contribute to bowel dysfunction

          -  Has evidence of intestinal obstruction

          -  Has a history of rectal bleeding not due to hemorrhoids or fissures within 6 months of
             screening

          -  Has an active malignancy of any type (participants with a history of successfully
             treated malignancy >5 years before the scheduled administration of study medication
             and participants with treated basal or squamous cell cancer may be enrolled)

          -  Is taking antispasmodics (e.g., dicyclomine), antidiarrheals (e.g., loperamide),
             prokinetics (e.g., metoclopramide), or locally acting chloride channel activators
             (e.g., lubiprostone)

          -  Is taking non-opioid medications known to cause constipation (e.g., iron sulfate
             therapy, tricyclic antidepressants)
Efficacy, Safety and Tolerability of the Co-administration of NVA237 Plus Indacaterol Once Daily Versus Indacaterol Once Daily in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: NVA237 50 µg and indacaterol 150 µg; Placebo to NVA237 and indacaterol 150 µg
Intervention description: NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.; Placebo to NVA237 and indacaterol 150 µg supplied as blistered capsules for inhalation.
Intervention MeSH terms: Glycopyrrolate; Bromides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 449.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Indacaterol; Glycopyrronium Bromide; COPD; bronchodilation

Summary:

      This study assessed the efficacy, safety and tolerability of the co-administration of NVA237
      plus indacaterol taken once daily versus indacaterol taken once daily in patients with
      moderate to severe Chronic Obstructive Pulmonary Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with moderate to severe stable Chronic Obstructive Lung Disease (COPD) Stage
             II or Stage III according to Global Initiative for Chronic Obstructive Lung Disease
             (GOLD) Guidelines.

          -  Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30 %
             and/or <80 % of the predicted normal, and a post-bronchodilator FEV1/Forced Vital
             Capacity (FVC) < 0.70 at screening.

          -  Current or ex-smokers who have a smoking history of at least 10 pack years

          -  Symptomatic patients according to daily diary data.

        Exclusion Criteria:

          -  Pregnant or nursing (lactating) women.

          -  Women of child-bearing potential unless using adequate contraception.

          -  Patients with Type I or uncontrolled Type II diabetes.

          -  Patients with a history of long time interval between start of Q wave and end of T
             wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart
             rate (QTc) measured at screening (Visit 2) (Fridericia's method) is prolonged

          -  Patients with paroxysmal (e.g. intermittent) atrial fibrillation

          -  Patients who have a clinically significant electrocardiogram (ECG) or laboratory
             abnormality at screening (Visit 2)

        Other protocol-defined inclusion/exclusion criteria may apply.
Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients
Condition: Stress Ulcer Prophylaxis
MeSH terms: Ulcer
Intervention: Esomeprazole; Cimetidine
Intervention description: iv esomeprazole 30 min intermittent infusions given for maximum 14 days; iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days
Intervention MeSH terms: Esomeprazole; Cimetidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 343.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: SUP; Upper GI bleeding; Seriously ill patients

Summary:

      The efficacy of esomeprazole will be compared versus cimetidine (a drug that previously
      demonstrated prevention of bleeding events) during treatment period in proportion of patients
      for the prevention of upper GI bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Critically ill patients

          2. Requirement for mechanical ventilation

          3. At least one major risk factor for stress ulcer related bleeding

        Exclusion Criteria:

          1. History of gastric or oesophageal surgery

          2. Evidence of active GI bleeding

          3. Advanced renal disease

          4. Treatment with any Proton Pump Inhibitors
Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan
Condition: Bacterial Meningitis
MeSH terms: Meningitis, Bacterial; Meningitis
Intervention: Meningococcal ACWY conjugate vaccine
Intervention description: All subjects received a single dose of Meningococcal ACWY conjugate vaccine and had blood draw at day 1 and day 29.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 341.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal; ACWY; bacterial meningitis; conjugate vaccine; healthy; children; adolescents; Taiwan

Summary:

      This study will evaluate the immunogenicity and safety of a single injection of Novartis
      Meningococcal ACWY conjugate vaccine in healthy subjects from 2 to 18 years in Taiwan.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy subjects from 2 up to and including 18 years of age

          2. Who are in good health as determined by : medical history, physical exam,clinical
             judgment of the investigator, who have a negative urine pregnancy test for female
             subjects ≥11 years of age

        Exclusion Criteria:

        Individuals not eligible to be enrolled in the study were those:

          1. Who had a previous confirmed or suspected disease caused by N. meningitidis.

          2. Who had household contact with and/or intimate exposure to an individual with
             culture-proven N. meningitidis infection within 60 days prior to enrolment.

          3. Who have previously been immunized with a meningococcal vaccine or vaccine containing
             meningococcal antigen(s) (licensed or investigational).

          4. Who have received any vaccines within 14 days (for inactivated vaccines) or 28 days
             (for live vaccines) prior to enrolment in this study or who are planning to receive
             any vaccine within 30 days from the study vaccines.

          5. Who have experienced within the 7 days prior to enrolment significant acute infection
             or have experienced fever within 3 days prior to enrolment.

          6. Who have any serious acute, chronic or progressive who have epilepsy or any
             progressive neurological disease or history of Guillain-Barre syndrome.

          7. Who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any
             vaccine components.

          8. Who have a known or suspected impairment/alteration of immune function, either
             congenital or acquired

          9. Who are known to have a bleeding diathesis, or any condition that may be associated
             with a prolonged bleeding time.

         10. Who have Down's syndrome or other known cytogenic disorders.
Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Pirfenidone; Placebo
Intervention description: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.; Placebo equivalent given as 3 divided doses 3 times per day.
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: 555.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Pirfenidone; ASCEND; IPF; FVC

Summary:

      PIPF-016 (ASCEND) is a Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the
      Efficacy and Safety of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis. The study
      objectives are to confirm the treatment effect of pirfenidone compared with placebo on change
      in percent predicted forced vital capacity (%FVC) in patients with idiopathic pulmonary
      fibrosis (IPF), and to confirm the safety of treatment with pirfenidone compared with placebo
      in patients with IPF.
    

Eligibility criteria:

        Select Inclusion Criteria:

          1. Diagnosis of idiopathic pulmonary fibrosis (IPF), consistent with the ATS 2011
             Guidelines, of 6-48 months' duration

          2. Age 40 to 80 at randomization

          3. Percent Forced Vital Capacity (%FVC) ≥50% and ≤90% at screening

          4. Percent Carbon Monoxide Diffusing Capacity (%DLCO) ≥30% and ≤90% at screening

        Select Exclusion Criteria:

          1. Forced expiratory volume in one second (FEV1)/FVC ratio <0.8 after administration of
             bronchodilator at Screening

          2. Expected to receive a lung transplant within 1 year from randomization or, for
             patients at sites in the United States, on a lung transplant waiting list at
             randomization

          3. Known explanation for interstitial lung disease

          4. History of asthma or chronic obstructive pulmonary disease

          5. Active infection

          6. Ongoing IPF treatments including investigational therapy, immunosuppressants, and
             cytokine modulating agents

          7. History of unstable or deteriorating cardiac or pulmonary disease (other than IPF)
             within the previous 6 months