bioihbjkbjnl/mcl2 huggingface dataset:
Phase III Trial of Coenzyme Q10 in Mitochondrial Disease
Condition: Mitochondrial Diseases
MeSH terms: Mitochondrial Diseases
Intervention: CoenzymeQ10; Placebo
Intervention description: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.; Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 12 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: mitochondrial diseases; respiratory chain complex I deficiencies; respiratory chain complex II deficiencies; respiratory chain complex III deficiencies; respiratory chain complex IV deficiencies; mutations of a gene coding for a respiratory chain component

Summary:

      To show that oral CoQ10 is a safe and effective treatment for children with inborn errors of
      mitochondrial energy metabolism due to defects in specific respiratory chain (RC) complexes
      or mitochondrial DNA (mtDNA) mutations, and that this beneficial action is reflected in
      improved motor and neurobehavioral function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 12 m - 17 y

          -  Biochemical proof of a deficiency of complex I, III or IV of the RC or a molecular
             genetic proof of a mutation in mtDNA, or an nDNA mutation in a gene known to be
             associated with dysfunction of the electron transport chain (e.g., SURF1)

          -  Willingness to stop all other medication regimens and supplements other than what the
             Steering and Planning Committee deems medically necessary

        Exclusion Criteria:

          -  A genetic mitochondrial disease other than those stipulated under inclusion criteria

          -  Intractable epilepsy, defined as grand mal seizures occurring with a frequency >
             4/month, despite treatment with conventional antiepileptic drugs

          -  Primary, defined organic acidurias other than lactic acidosis (e.g., propionic
             aciduria

          -  Primary disorders of amino acid metabolism

          -  Primary disorders of fatty acid oxidation

          -  Secondary lactic acidosis due to impaired oxygenation or circulation (e.g., due to
             severe cardiomyopathy or congenital heart defects)

          -  Severe anemia, defined as a hematocrit <30%

          -  Malabsorption syndromes associated with D-lactic acidosis

          -  Renal insufficiency, defined as (1) a requirement for chronic dialysis or (2) serum
             creatinine ≥ 1.2 mg/dl or creatinine clearance <60 ml/min

          -  Primary hepatic disease unrelated to mitochondrial disease

          -  Allergy to CoQ10 or placebo ingredients

          -  Pregnancy
Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine (QIV) in Children Previously Vaccinated in Trial V118_05
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV); non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
Intervention description: 1 dose 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months; 1 dose 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 607.0
Sex: All
Minimum age: 12 Months
Maximum age: 84 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared
      to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in Trial
      V118_05
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subject who has completed their Day 181 clinic visit for non-naïve
             subjects or their Day 209 clinic visit for naïve subjects in parent study.

          2. Individuals who give written informed consent, who can comply with study procedures,
             and who are available for follow-up

        Exclusion Criteria:

          1. Individuals recently vaccinated against influenza.

          2. Subjects with contraindications to receive influenza vaccine.

          3. Please contact the site for additional eligibility criteria.
Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes
Condition: Diabetes, Type 1; Diabetes, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Intervention: Technosphere® Insulin Inhalation Powder; Usual Care
Intervention description: Inhalation, 15U/30U; Subjects will receive antidiabetes treatment at the discretion of their physicians
Intervention MeSH terms: Insulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2053.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Pulmonary Safety in Diabetics with T/I
    

Eligibility criteria:

        Inclusion Criteria:

          -  For All Subjects:

               -  Nonsmoking

               -  Body mass index <42 kg/m2

               -  FEV1 greater than or equal to 70% of predicted , DLco and TLC greater than or
                  equal to 80% of predicted at screening,

               -  No abnormalities in screening pulmonary radiology

          -  For Subjects with diabetes mellitus:

               -  Type 1 or type 2 diabetes for at least 2 years

               -  HbA1c greater than or equal to 6.6 % and less than or equal to 12.0 %

          -  For Subjects without abnormalities in glucose control:

               -  No history of diabetes

               -  Normal results from a formal glucose tolerance test

        Exclusion Criteria:

          -  History of chronic obstructive pulmonary disease, asthma, or other significant
             pulmonary disease

          -  Significant renal, hepatic, or cardiac disease

          -  Women who are pregnant, lactating, or planning on becoming pregnant

          -  Subjects who have participated in studies of other investigational drugs within the
             previous 3 months

          -  Evidence of severe complications of diabetes
Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation
Condition: Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: N-methylnaltrexone bromide (MOA-728)
Intervention description: MOA-728 will be administered as per the dose and schedule specified in the arm.
Intervention MeSH terms: Bromides; Methylnaltrexone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1040.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: treatment for opioid-induced constipation

Summary:

      This study is designed to evaluate the long-term safety and tolerability of the subcutaneous
      (SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of
      opioid-induced constipation in participants with nonmalignant pain. The study consists of a
      2-week screening period, a 48-week open-label treatment period and a 2 week follow-up period.
      Participants will need to agree to self-administer SC injections, complete daily diaries, and
      check-in via a daily telephone call during the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women 18 years or older.

          -  A history of pain of at least 2 months duration before the screening visit due to
             documented underlying nonmalignant condition.

          -  A history of constipation due to opioid use during 1 month before the screening visit.

        Exclusion Criteria:

          -  A diagnosis of significant gastrointestinal (GI) disorder such as bowel obstruction,
             fecal incontinence or rectal prolapse.

          -  A history of active inflammatory bowel disease, irritable bowel syndrome, or megacolon
             within 6 months before the screening visit.

          -  A history of malignancy, other than basal cell or squamous cell skin carcinoma, within
             5 years before the screening visit.

          -  A history of chronic constipation before initiation of opioid therapy.
The Effect of Omega-3 Polyunsaturated Fatty Acids in Congestive Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: LOVAZA (Omega-3); Placebo
Intervention description: LOVAZA 4 gm q24 for 8 weeks Each 1-gram capsule of LOVAZA (omega-3-acid ethyl esters) contains at least 900 mg of the ethyl esters of omega-3 fatty acids. These are predominantly a combination of ethyl esters of eicosapentaenoic acid (EPA - approximately 465 mg) and docosahexaenoic acid (DHA - approximately 375 mg).; 4 capsules of placebo every 24 hours
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart Failure; omega 3; lovaza; VO2 max

Summary:

      A diet rich in Omega-3 (fish oil) reduces plasma triglycerides and the risk for ischemic
      heart disease. Recently, a large trial evaluating treatment with Omega 3 in heart failure
      patients suggested that omega 3 may lower the risk of death from CHF. The mechanism of this
      potential benefit is not well understood.

      Methods:

      Forty patients will be enrolled in the study. Twenty patients will receive Omega 3 (lovaza 4
      gm a day) and 20 patients will receive placebo. All subjects will have assessment of their
      exercise capacity and blood vessel function before and after an 8 week treatment period.
      About 4 table spoons of blood will be drawn throughout the study.

      Expected results:

      The investigators believe that omega 3 may improve the ability to exercise and improve blood
      vessel function.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects with CHF due to systolic dysfunction followed at the outpatient facilities of
        Columbia University Medical Center will be screened and subjects will be asked to
        participate if the following criteria are met:

          -  Older than 18 years.

          -  Symptomatic heart failure (New York Heart Association functional class II-III).

          -  Ischemic or non-ischemic cardiomyopathy.

          -  Left ventricular ejection fraction (EF) 40% or lower.

          -  Peak oxygen uptake (VO2, peak) between 10 and 17 mL O2/min/kg.

          -  Be on appropriate, stable medical treatments for heart failure, including (unless
             shown to be intolerant) a diuretic, an angiotensin-converting enzyme inhibitor and/or
             angiotensin-receptor blocker and a beta-blocker, pacemaker or ICD or CRT.

        Exclusion Criteria:

          -  Unable to perform treadmill exercise

          -  Pregnancy

          -  Recent myocardial infarction (within 3 months).

          -  Clinically significant angina.

          -  Hospitalization for heart failure requiring intravenous treatments within 30 days.

          -  Allergy to fish
Efficacy and Safety Study of Indacaterol Maleate/Glycopyrronium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients.
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QVA149; Umeclidinium/vilanterol; Placebo (umeclidinium/vilanterol ); Placebo (QVA149)
Intervention description: QVA149 capsules for inhalation, delivered via QVA149 SDDPI; Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler; Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler; Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI
Intervention MeSH terms: Glycopyrrolate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 355.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease (COPD)

Summary:

      The purpose of this study is to demonstrate that the efficacy of the combination product
      QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a
      pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adults aged ≥40 yrs

          -  Smoking history of at least 10 pack years

          -  Diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) as classified by the
             Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2015)

          -  Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)< 80% and ≥ 30% of the
             predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

          -  Modified Medical Research Council questionnaire grade of 2 or higher

        Exclusion Criteria:

          -  Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1

          -  Patients with concomitant pulmonary disease

          -  Patients with a history of asthma

          -  Any patient with lung cancer or a history of lung cancer

          -  Patients with a history of certain cardiovascular co-morbid conditions

          -  Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency

          -  Patients in the active phase of a supervised pulmonary rehabilitation program

          -  Patients contraindicated for inhaled anticholinergic agents and β2 agonists

          -  Other protocol-defined inclusion/exclusion criteria may apply
Tiotropium / Respimat One-Year Study
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Tiotropium Inhalation Solution; Placebo
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 1007.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the
      Respimat inhaler in patients with COPD.
    

Eligibility criteria:

        Criteria

          -  Patients with stable moderate to severe COPD and a smoking history of at least 10 pack
             years were eligible for inclusion in the study. Patients with significant diseases
             other than COPD were excluded as were patients with a recent history of myocardial
             infarction, history of malignancy, unstable or life-threatening cardiac arrhythmia,
             narrow-angle glaucoma, asthma or other allergic conditions. Patients treated with
             cromolyn, nedocromil, oral beta-adrenergics or unstable doses of oral corticosteroids
             were ineligible for inclusion in the study as were patients who had received previous
             treatment with tiotropium.
An Efficacy and Safety Study for JNS001 in Adults With Attention-Deficit Hyperactivity Disorder
Condition: Attention-Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: JNS001; Placebo
Intervention description: Participants will receive JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.; Participants will receive matching placebo orally once daily for 8 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 284.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Concerta; Adults; Attention-Deficit/Hyperactivity Disorder; ADHD; Methylphenidate hydrochloride

Summary:

      The main purpose of this study is to evaluate the efficacy of JNS001 titrated to daily doses
      of 18 to 72 mg in adults with attention-deficit hyperactivity disorder (ADHD) relative to
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who meet the criteria of ADHD (predominantly inattentive type [314.00],
             predominantly hyperactive-impulsive type [314.01], and combined type [314.01]) of
             DSM-IV-TR both at present and in childhood, based on Conners' Adult ADHD Diagnostic
             Interview for DSM-IV (CAADID) at screening

          -  DSM-IV Total ADHD Symptoms scores (18 items) of CAARS-O: SV score of = 24 as
             determined by investigator or co-investigator at baseline

          -  Healthy on the basis of physical examination, medical history, vital signs, 12-lead
             ECG and clinical laboratory tests performed at screening

          -  Women of childbearing potential must have a negative urine pregnancy test at screening

          -  Patients (and their legally-acceptable representative if patients are 18 or 19 years
             of age) must have signed an informed consent form (ICF), indicating that they
             understand the purpose of and procedures required for the study and are willing to
             participate in the study.

        Exclusion Criteria:

          -  Presence or history of co-morbid psychiatric diagnosis per DSM-IV-TR criteria of
             bipolar I disorder, schizophrenia, schizoaffective disorder, or severe obsessive
             compulsive disorders

          -  Presence of co-morbid psychiatric diagnosis per DSM-IV-TR criteria of pervasive
             developmental disorder (including autistic disorder or Asperger's disorder),
             suicidality, or any other diagnosis that in the judgment the investigator or
             co-investigator would exclude the patient from the study

          -  Presence of motor tics, history of Tourette's disorder, or family history of
             Tourette's disorder

          -  Known or suspected mental retardation
DE-111 Against Timolol Ophthalmic Solution 0.5%
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: DE-111 ophthalmic solution; Timolol ophthalmic solution 0.5%; Placebo ophthalmic solution
Intervention MeSH terms: Timolol; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 166.0
Sex: All
Minimum age: 20 Years
Keywords: Primary open angle glaucoma or ocular hypertension

Summary:

      DE-111 ophthalmic solution will be evaluated for superiority in comparison with Timolol
      ophthalmic solution 0.5%, in IOP(intraocular pressure ) -lowering effect in primary
      open-angle glaucoma or ocular hypertension patients, in a multicenter, randomized,
      double-masked, parallel-group comparison study. Safety will be compared and evaluated as
      well.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with primary open angle glaucoma or ocular hypertension

          -  Provided signed, written informed consent

          -  20 years of age and older

          -  If a subject is a female of childbearing potential, she must utilize reliable
             contraceptive throughout the study, and must have a negative urine pregnancy test
             prior to enrollment into this study

        Exclusion Criteria:

          -  Females who are pregnant, nursing or planning a pregnancy, or females of childbearing
             potential who are not using a reliable method of contraception

          -  Presence of any abnormality or significant illness that could be expected to interfere
             with the study
Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
Condition: Dry Eye Syndromes; Keratoconjunctivitis Sicca
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Keratoconjunctivitis
Intervention: KPI-121 0.25% Ophthalmic Suspension; Vehicle of KPI-121 0.25% Ophthalmic Suspension
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 918.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ocular Discomfort; Pain; Corticosteroid; Hyperemia; Dry Eye

Summary:

      The primary purpose of this study is to determine the efficacy and safety of KPI-121 0.25%
      ophthalmic suspension compared to vehicle (placebo) in subjects who have a documented
      clinical diagnosis of dry eye disease. The product will be studied over 14 days, with 1-2
      drops instilled in each eye four times daily (QID).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a documented clinical diagnosis of dry eye disease in both eyes

        Exclusion Criteria:

          -  Known hypersensitivity or contraindication to the investigational product(s) or
             components

          -  History of glaucoma, Intraocular Pressure (IOP) >21 mmHg at the screening or
             randomization visits, or being treated for glaucoma in either eye.

          -  Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in
             judgment of Investigator could confound study assessments or limit compliance; or have
             been exposed to an investigational drug within 30 days prior to screening.

          -  In the opinion of the Investigator or study coordinator, be unwilling or unable to
             comply with study protocol or unable to successfully instill eye drops.