bioihbjkbjnl/mcl2 huggingface dataset:
Extended Release Naltrexone for Opioid-Dependent Youth
Condition: Drug Dependence
MeSH terms: Substance-Related Disorders
Intervention: Extended Release Naltrexone; Psychosocial Treatment; Buprenorphine
Intervention description: naltrexone for extended release injectable suspension; Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.; Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study.
Intervention MeSH terms: Naltrexone; Buprenorphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 288.0
Sex: All
Minimum age: 15 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: opioid dependence

Summary:

      The purpose of this study is to compare 6-month treatment outcomes for 15-21 year old
      opioid-dependent youth receiving extended release naltrexone (XR-NTX) v. Treatment as Usual
      (TAU).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets Diagnostic and Statistical Manual-IV criteria for opioid dependence, physiologic
             subtype;

          -  Within 3 days of admission to MMTC;

          -  Age between 15 and 21, inclusive;

          -  Able and willing to provide informed consent to be randomly assigned to XR- NTX or
             TAU; and for participants under 18 years of age, parental or guardian consent and
             participant assent.

        Exclusion Criteria:

          -  Liver function test levels (Alanine Transaminase, Aspartate Transaminase) four times
             greater than normal;

          -  Unstable medical or psychiatric illness (e.g., schizophrenia) that might make
             participation hazardous;

          -  History of serious suicide attempt in the past 6 months;

          -  History of allergic reaction to naloxone, and/or naltrexone;

          -  Current chronic pain condition for which opioids are deemed necessary for ongoing
             care;

          -  blood coagulation disorder (e.g., hemophilia);

          -  Body Mass Index > 40;

          -  If female, pregnant, lactating, unwilling or unable (due to parental objection) to use
             FDA-approved contraceptive methods;

          -  meeting DSM-IV criteria for benzodiazepine dependence
Pilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment
Condition: Heartburn
MeSH terms: Heartburn
Intervention: Esomeprazole 20 mg; Placebo
Intervention description: Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate); Placebo capsules
Intervention MeSH terms: Esomeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 22 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this pilot study is to investigate the association between gastric acid
      suppression and relief of 24 hour heartburn following treatment with the proton pump
      inhibitor (PPI) drug esomeprazole in frequent heartburn patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed symptom history of heartburn, acid regurgitation, or epigastric pain of at
             least 3 months, while treating with gastric acid modulating therapy (antacids, H2
             receptor antagonists (H2RAs) and/or PPIs).

          -  Heartburn symptoms that average 3 times per week or greater including at least 2
             episodes of nighttime heartburn symptoms per week over the past 30 days.

          -  When heartburn medications were used, subject had heartburn symptoms that were
             responsive to antacids, non prescription H2RAs, or short term non prescription or
             prescription PPIs at approved doses but complete resolution of heartburn was not
             achieved.

        Exclusion Criteria:

          -  A history (past or present) of erosive esophagitis verified by endoscopy.

          -  The need for continuous treatment with H2RAs, PPIs, gastric prokinetic drugs, or
             antacids for any indication through the study (eg, long term prescription therapy).

          -  Subjects requiring continuous intervention by a physician for the treatment of GERD
             (ie, treatment of erosive esophagitis or prevention of relapse of healed esophagitis).
Beta Blockade in in Traumatic Brain Injury
Condition: Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Intervention: Propranolol
Intervention MeSH terms: Propranolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is test the effect of beta-adrenergic blockade on mortality in
      patients with traumatic brain injury with the hypothesis being that the addition of beta
      blockade to the treatment regime of this patient population will lower mortality and supress
      the catecholamine surge that accompanies traumatic brain injury as compared to those who do
      not receive beta blockade.

      Half the patients will be randomized to receive propranolol and half will be randomized to
      receive no beta blocker.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects ages 18 and older with isolated traumatic brain injury as defined by Glasgow
             Coma Scale score 12 or less with documented injury on head CT and limited injury to
             the rest of the body. (Abbreviated Injury Scale (AIS) must be < or = 3 from other body
             areas.)

        Exclusion Criteria:

          -  Subjects <18 years of age, prisoners, those on beta-blockers as home medication, those
             who are pregnant, those with severe liver disease, those taking vasopressors, those
             with acute coronary syndrome, and those with severe injury to another body region (AIS
             >3).

          -  Subjects who cannot be enrolled within 48 hours of admission following acute
             resuscitation will not be enrolled into this study.
Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery
Condition: Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Intervention: Collagen Matrix in Glaucoma Filtering Surgery; Mitomycin-C(MMC) and glaucoma filtering surgery
Intervention description: Collagen Matrix implantation in Glaucoma Filtering Surgery; If mitomycin -C is applied, a single cellulose sponge soaked with Mitomycin-C(MMC) (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.
Intervention MeSH terms: Mitomycins; Mitomycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ologen; collagen matrix; glaucoma; trabeculectomy; Mitomycin-C

Summary:

      To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation
      and Mitomycin-C(MMC) in glaucoma surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Open angle glaucoma

          -  Maxima anti-glaucoma medication failed

          -  Age>18

          -  Able to complete the follow up

        Exclusion Criteria:

          -  Topical eye inflammation

          -  Angle closure glaucoma

          -  Deformity glaucoma

          -  One eye glaucoma

          -  Previous conjunctiva opened

          -  Allergy to collagen
Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Risperidone; Olanzapine; Quetiapine; Aripiprazole
Intervention description: Continued treatment with the medication risperidone for schizophrenia for up to 6 months in study; Continued treatment with the medication olanzapine for schizophrenia for up to 6 months in study; Continued treatment with the medication quetiapine for schizophrenia for up to 6 months in study; Switching medication to aripiprazole for schizophrenia for up to 6 months in study
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 215.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The study will compare the effectiveness of antipsychotic medications for patients with
      schizophrenia or schizoaffective disorder for whom a medication change may be indicated
      because of an increased risk of cardiovascular disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with schizophrenia or schizoaffective disorder

          -  Currently treated with olanzapine, quetiapine or risperidone

          -  BMI greater than or equal to 27

          -  Non-HDL cholesterol greater than or equal to 130 mg/dL (if non-HDL cholesterol is
             between 130 - 139 mg/dL, then LDL cholesterol must be greater than 100 mg/dL).

        Exclusion Criteria:

          -  Diabetes (FBS greater than or equal to 126) or treatment with oral hypoglycemic drug
             or insulin

          -  Non-HDL cholesterol greater than 300 mg/dL

          -  Serum triglycerides greater than 500 mg/dL

          -  Patients in the first episode of schizophrenia or schizoaffective disorder

          -  Known hypersensitivity to aripiprazole

          -  On weight loss medications
The Effect of Thoracic Epidural Anesthesia With Different Block Level on Propofol Induction
Condition: Target Controlled Infusion (TCI); Thoracic Epidural Anesthesia; Block Level; Gastrointestinal Surgery
MeSH terms: Aortic Dissection
Intervention: 1% lidocaine; 2% lidocaine; 0.9% normal saline
Intervention description: epidural anesthesia with 1% lidocaine 10ml before propofol TCI; epidural anesthesia with 2% lidocaine 5ml before propofol TCI; epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 45.0
Sex: All
Minimum age: 40 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: effect-site concentration; propofol; thoracic epidural anesthesia

Summary:

      It is a prospective, randomized, placebo-controlled study to investigate the effect of TEA
      with different block level on propofol concentration during general anesthesia induction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologists (ASA) I-II physical status,

          -  aged 40-60 yr,

          -  BMI 19-25 kg/m2,

          -  undergoing elective gastrointestinal surgery

        Exclusion Criteria:

          -  patients with cardiovascular or neurological disease, drug or alcohol abuse and
             absolute contraindications for neuraxial blockade.
Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) With Atomoxetine in Young Adults and Its Effects on Functional Outcomes
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine hydrochloride; Placebo
Intervention description: 20-50 mg, twice a day per by mouth for 12 weeks, followed by up to an additional 12 weeks; twice a day, by mouth for 12 weeks
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 445.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: No

Summary:

      This study will evaluate atomoxetine's efficacy in treating attention-deficit/hyperactivity
      disorder (ADHD) symptoms and atomoxetine's effect on functional outcomes in young adults.

      A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

      This study also has an observational community sample arm in which patients will complete all
      the efficacy measurements via web-based self reporting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  positive attention-deficit/hyperactivity disorder (ADHD) diagnosis with at least
             moderate severity

          -  male or female 18 to 30 years of age

          -  must be able to swallow capsules

          -  must be able to communicate effectively in English

          -  must not have cognitive impairment

          -  be reliable to keep appointments for clinic visits and all related tests

        Exclusion Criteria:

          -  patients diagnosed with obsessive-compulsive disorder, bipolar affective disorder, or
             psychosis

          -  females who are pregnant or breastfeeding

          -  patients with dementia or traumatic brain injury

          -  patients with a history of severe allergy to atomoxetine

          -  have untreated hypertension or thyroid problem

          -  have serious medical illness including any heart, liver, kidney, respiratory, blood,
             endocrine, or neuromuscular diseases
Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants
Condition: Prematurity; Respiratory Distress Syndrome; Patent Ductus Arteriosus
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Premature Birth; Ductus Arteriosus, Patent; Syndrome
Intervention: Survanta (beractant); Curosurf (poractant)
Intervention description: beractant 4.0 ml/kg/dose (100 mg phospholipid/kg/dose, intratracheal, every 6-12 hours as needed for respiratory distress syndrome for initial and subsequent doses, maximum of 4 doses); poractant alfa 2.5 ml/kg/dose initial (200 mg phospholipid/kg), and 1.25 ml/kg/dose subsequent (100 mg/kg/subsequent dose), intratracheal, every 12-24 hours as needed for respiratory distress syndrome, maximum of 3 doses)
Intervention MeSH terms: Poractant alfa; Beractant
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Maximum age: 8 Hours
Healthy volunteers: No
Keywords: Very Premature; RDS; Surfactant

Summary:

      Approval of surfactant by the FDA in 1989 for the treatment of Respiratory Distress Syndrome
      (RDS) in premature infants greatly improved survival rates. Newer surfactants approved by the
      FDA were more concentrated and had a more rapid onset of action. The overall efficacy of
      newer surfactants appeared similar until in 2004, Ramanathan and colleagues suggested that a
      double dose of Curosurf improved survival in infants 25-32 weeks gestational age, compared to
      infants treated with Survanta, the most commonly used surfactant preparation in the United
      States. While the data was suggestive, it was not clear that the improvement in survival was
      reproducible or that Curosurf was responsible for the improved survival rates.

      The purpose of this study was to investigate the role of Curosurf in improving lung function
      and survival rates and reducing the complications of prematurity in very premature infants <
      30 weeks gestational age at birth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  <29 6/7 and >24 0/7 weeks gestational age

          -  Inborn at the participating institution enrolling the patient

          -  FIO2 >25% and Intubated with mean airway pressure > 5 cm H20

          -  <8 hours age at randomization

          -  Signed informed consent from parent(s)

        Exclusion Criteria:

          -  <500 g birth weight

          -  <24 0/7 weeks gestational age (best estimate)

          -  Prolonged Premature Rupture of membranes >3 weeks (21 days)

          -  Apgar score < 3 at 5 minutes

          -  Impending death anticipated within the first 3 days of life, moribund

          -  Severe congenital anomalies
Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects From 2 Months to 55 Years of Age in the Republic of South Korea
Condition: Meningococcal Disease
MeSH terms: Meningococcal Infections
Intervention: MenACWY-CRM (Menveo)
Intervention description: One dose administered intramuscularly preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle in children, adolescents and adults.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3948.0
Sex: All
Minimum age: 2 Months
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: conjugate vaccine; phase IV clinical trial; Neisseria meningitidis

Summary:

      A multicenter, single arm, post-marketing surveillance study. This study is a postlicensure
      requirement of the Korea Food and Drug Administration (KFDA) to provide continued safety
      evaluation of MenACWY in the Korean population from 2 months to 55 years of age, receiving
      MenACWY-CRM vaccination according to routine clinical practice and prescribing information.
    

Eligibility criteria:

        Inclusion Criteria:

        Individuals eligible for enrolment in this study are those:

          1. male and female subjects from 2 months to 55 years of the age at the time of Visit 1
             (including all 55 years old subjects, up to one day before their 56th year birthday),
             who are scheduled to receive vaccination with MenACWY-CRM conjugate vaccine, according
             to the local prescribing information and routine clinical practice;

          2. to whom the nature of the study has been described and the subject or subject's
             parent/legal representative has provided written informed consent;

          3. whom the investigator believes that the subject can and will comply with the
             requirements of the protocol (e.g., completion of the Diary Card);

          4. who are in good health as determined by the outcome of medical history, physical
             assessment and clinical judgment of the investigator.

        Exclusion Criteria:

        1. Contraindication, special warnings and/or precautions, as evaluated by the
        investigators, reported in the MenACWY-CRM conjugate vaccine Korean prescribing
        information. In particular, should not be included in the study a subject who has ever had:

          -  an allergic reaction to the active substances or any of the other ingredients of the
             study vaccine; an allergic reaction to diphtheria toxoid;

          -  an illness with high fever; however, a mild fever or upper respiratory infection (for
             example cold) itself is not a reason to delay vaccination. Special care should be
             taken for subjects having haemophilia or any other problem that may stop your blood
             from clotting properly, such as persons receiving blood thinners (anticoagulants).
Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors
Condition: Schizophrenia; Cigarette Smoking
MeSH terms: Schizophrenia; Cognition Disorders; Cognitive Dysfunction
Intervention: Varenicline; Placebo for varenicline
Intervention description: Varenicline 1-2 mg/day; Placebo
Intervention MeSH terms: Varenicline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: schizophrenia; smoking; nicotine; cognitive deficits; nicotinic receptors; Cognitive Deficits in Schizophrenia

Summary:

      This is a 8-week double-blind placebo controlled parallel group study of the efficacy of
      varenicline (Chantix) for smoking cessation in schizophrenic patients, and its effect on
      cognitive function in patients with schizophrenia.At some sits evaluation of smoking measures
      is extended to 12 weeks. Correlations will be made with biological predictors of efficacy: a)
      measures of nicotinic receptors in lymphocytes b) DNMT1 and GAD67 mRNA in lymphocytes.
      Subjects will be current cigarette smokers or history of regular smokers.
    

Eligibility criteria:

        Inclusion Criteria:

        Diagnosis of Schizophrenia or Schizoaffective Disorder Current Cigarette Smoker or History
        of Chronic Cigarette smoking Age 18-65 Currently taking antipsychotic medication

        Exclusion Criteria:

        prior history of hospitalization for acute myocardial infarction or stroke, or persistent
        angina pectoris with current symptoms Patients who have previously tried varenicline and
        have stopped taking it because of side-effects of severe nausea or vomiting suicide attempt
        in the last year and or have had prominent or serious suicidal thoughts in the past year
        Women who are pregnant, nursing, or unable to use reliable contraception significant renal
        impairment(Creatinine ≥ 1.5) baseline Hamilton Depression Scores is >20