bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Intervention: Dexlansoprazole MR; Dexlansoprazole MR
Intervention description: Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 12 months.; Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 12 months.
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 591.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastroesophageal Reflux Disease

Summary:

      The purpose of this study is to determine the long-term safety profile of daily treatment
      with dexlansoprazole MR in subjects with gastroesophageal reflux disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have successfully completed either T-GD04-082 (NCT00251745) or
             T-GD04-083 (NCT00251758) or have a diagnosis of gastroesophageal reflux disease with
             or without erosive esophagitis.

        Exclusion Criteria:

          -  Any condition that may require inpatient surgery during the course of the study.

          -  Use of prescription or non-prescription proton pump inhibitors, histamine (H2)
             receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study.

          -  Use of antacids [except for study supplied Gelusil®].

          -  Subjects using drugs with significant anticholinergic effects such as tricyclics who
             cannot stay on a stable dose for 4 weeks prior to dosing and throughout the study.

          -  Evidence of uncontrolled systemic disease.

          -  Allergy to any proton pump inhibitor including Prilosec, Nexium, Prevacid, or others,
             any component of dexlansoprazole MR, or Gelusil/antacid.

          -  Need to take blood thinners.

          -  Need to take more than 12 doses of non-steroidal anti-inflammatory drugs per month.

          -  Had cancer (except basal cell cancer of the skin) within 3 years prior to screening.

          -  Has other esophageal disease including Barrett's esophagus or strictures requiring
             dilation.

          -  Has had radiation or cryotherapy to the esophagus.

          -  Has active gastric or duodenal ulcers within 4 weeks of starting study drug.

          -  Has a history of hypersecretory conditions such as Zollinger Ellison Syndrome.

          -  History of alcohol abuse.

          -  Has acquired immunodeficiency syndrome.

          -  Has had acute upper gastrointestinal bleeding within 4 weeks of endoscopy.

          -  Received a blood product transfusion within 3 months of taking the first dose of study
             drug.

          -  Has previously participated in another dexlansoprazole MR long-term treatment clinical
             trial.
Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX)
Condition: Non Small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: cetuximab + cisplatin + vinorelbine; cisplatin + vinorelbine
Intervention description: cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.; cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Intervention MeSH terms: Cisplatin; Cetuximab; Vinorelbine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1861.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cetuximab; Non small cell lung cancer; Lung cancer; Cisplatin/vinorelbine; Monoclonal antibody; Erbitux

Summary:

      The purpose of this trial is to investigate the efficacy of cetuximab in combination with
      chemotherapy in comparison to chemotherapy alone in patients with advanced non small cell
      lung cancer who did not received prior chemotherapy. Overall survival will be taken as
      primary measure of efficacy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of histologically or cytologically confirmed NSCLC, stage IIIb with
             documented malignant pleural effusion or stage IV

          -  Immunohistochemical evidence of EGFR expression on tumor tissue

          -  Presence of at least 1 bi-dimensionally measurable index lesion, whereby index lesions
             must not lie in an irradiated area

        Exclusion Criteria:

          -  Previous exposure to monoclonal antibodies, signal transduction inhibitors or
             EGFR-targeting therapy

          -  Previous chemotherapy for NSCLC

          -  Documented or symptomatic brain metastasis

          -  Superior vena cava syndrome contra-indicating hydration

          -  Previous malignancy in the last 5 years except basal cell carcinoma of the skin or
             pre-invasive carcinoma of the cervix
Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD
Condition: Attention Deficit Hyperactivity Disorder; ADHD
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Methylphenidate Hydrochloride Extended Release Capsules; Placebo
Intervention description: Biphentin Methylphenidate ER Once-A-Day Capsules; Placebo capsules
Intervention MeSH terms: Methylphenidate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 230.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: inattention; impulsivity; hyperactivity; ADHD

Summary:

      This multi-center parallel study is designed to study the efficacy and safety of fixed doses
      of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo
      group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are
      between 6 and 18 years old.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females ages 6 up to 18

          -  ADHD diagnosis with ADHD Rating Scale - 4th Edition scores ≥ 90th percentile

          -  In need of treatment for ADHD and able to have 2-day washout from previous medication

          -  Females of child-bearing potential not pregnant and practice birth control

          -  Subject and parent/guardian willing to comply with protocol

          -  Signed consent and assent

        Exclusion Criteria:

          -  Estimated Full Scale intellectual level below 80 using Wechsler Abbreviated Scale of
             Intelligence (WASI)

          -  Current primary psychiatric diagnosis of other listed disorders

          -  Chronic medical illnesses: seizure, hypertension, thyroid disease, cardiac, family
             history of sudden death, glaucoma

          -  Use of psychotropic central nervous system (CNS) meds having effect exceeding 14 days
             from screening

          -  Planned use of prohibited drugs

          -  Is pregnant or breast-feeding

          -  Significant ECG or laboratory abnormalities

          -  Experimental drug or medical device within 30 days prior to screening

          -  Hypersensitivity to methylphenidate

          -  Inability or unwillingness to comply with protocol

          -  Well controlled on current ADHD treatment

          -  Inability to take oral capsules
Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis
Condition: Chronic Kidney Disease, Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Cinacalcet HCl; Standard of Care
Intervention description: Capsules were opened and either sprinkled onto soft food (≥ 5 mg dose) or suspended into a sucrose syrup (≥ 2.5 mg dose) to create a liquid suspension for administration. Tablets were used for doses of 30 mg and higher in participants who could swallow tablets.; Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
Intervention MeSH terms: Cinacalcet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease, Secondary Hyperparathyroidism, Dialysis, Pediatric

Summary:

      The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma
      intact parathyroid hormone (iPTH) level by ≥ 30%.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 6 - < 18 years

          -  Diagnosis of SHPT with the mean of the two consecutive central laboratory iPTH values
             ≥ 300 pg/mL during screening

          -  Corrected calcium value of ≥ 8.8 mg/dL during screening

          -  Diagnosis of CKD, receiving either hemodialysis or peritoneal dialysis, for ≥ 30 days
             prior to screening

          -  Parent or legally acceptable representative has provided written informed consent and
             subject has provided written assent when required by institutional guidelines

        Exclusion Criteria:

          -  History of congenital long QT syndrome, second or third degree heart block,
             ventricular tachyarrhythmias or other conditions associated with prolonged QT interval

          -  Corrected QT interval (QTc) > 500 ms, using Bazett's formula

          -  QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is
             provided by the investigator after consultation with a pediatric cardiologist

          -  Use of grapefruit juice, herbal medications, or potent cytochrome P450 3A4 (CYP3A4)
             inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole)

          -  Use of concomitant medications that may prolong the QTc interval (eg, ondansetron,
             albuterol)