bioihbjkbjnl/mcl2 huggingface dataset:
A Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis
Condition: Candidemia
MeSH terms: Candidiasis; Candidemia; Candidiasis, Invasive
Intervention: Anidulafungin/Fluconazole
Intervention description: Anidulafungin:IV,100 mg daily preceded by an initial 200 mg dose on Day 1, 14 - 42 days Fluconazole: IV/Oral, 400mg,QD,14 - 42 days
Intervention MeSH terms: Fluconazole; Anidulafungin
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase 3b; Efficacy and Safety evaluation of Anidulafungin; ICC

Summary:

      In the treatment of patients with candidemia and/or other forms of invasive candidiasis ,
      Anidulafungin is at least as effective and safe as Fluconazole.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of candidemia or invasive candidiasis.

          -  Presence of one or more of signs and symptoms of acute fungal infection.

        Exclusion Criteria:

          -  Subjects who received greater than 48 hours of systemic antifungal treatment for the
             Candida infection for which they will be enrolled.

          -  Subjects with hypersensitivity to echinocandins or azole therapy or drug excipients.
Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants
Condition: Whole Cell Pertussis; Diphtheria; Hepatitis B; Tetanus; Haemophilus Influenzae Type b
MeSH terms: Hepatitis B; Diphtheria
Intervention: Tritanrix™-HepB/Hiberix™ Kft.; Tritanrix™-HepB/Hiberix™; Hiberix™; Polyribosil-Ribitol-Phosphate (PRP) vaccine; Tritanrix™-HepB Kft
Intervention description: GlaxoSmithKline (GSK) Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria (D), tetanus (T), whole cell Bordetella pertussis (Pw), hepatitis B vaccine with new sources of D, T and Pw antigens mixed with Haemophilus influenzae type b (Hib2.5) vaccine.; GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine; GSK Biologicals' Haemophilus influenzae type b vaccine; plain PRP polysaccharide vaccine; GSK Biologicals Korlatolt Felelossegu Tarsasag [Kft] (Limited Company) combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B vaccine with new sources of D, T and Pw antigens produced at GSK Biologicals Kft., Gödöllö, Hungary.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 745.0
Sex: All
Minimum age: 10 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to
      assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.
    

Eligibility criteria:

        Inclusion criteria:

        For subjects receiving Plain PRP followed by DTPw-HBV:

        Male or female infant, 10 to 11 months of age, who previously completed the three-dose
        primary vaccination course with the DTPw-HBV/Hib vaccine.

        For subjects receiving DTPw-HBV/Hib or DTPw-HBV + Hib:

        Male or female infant, 15-18 months of age, who previously completed the three-dose primary
        vaccination course with the DTPw-HBV/Hib vaccine.

        For all subjects:

          -  Subjects who the investigator believes that their parent/guardian can and will comply
             with the requirements of the protocol.

          -  Free of obvious health problems as established by medical history and clinical
             examination

        Exclusion criteria:

          -  Use of any investigational or non-registered product other than the study vaccine(s)
             within 30 days preceding administration of the study vaccine, or planned use during
             the study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to administration of the study vaccine.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             starting 30 days before and ending 30 days after administration of the study vaccine
             with the exception of oral polio vaccine.
Comparison of Efficacy of Indacaterol Versus Placebo Over 12 Weeks
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol; Placebo to indacaterol
Intervention description: Once daily via single-dose dry powder inhaler (SDDPI); Once daily via SDDPI
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 318.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Indacaterol

Summary:

      This 12-week study evaluated the efficacy and safety of indacaterol versus placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for
             Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

               1. Smoking history of at least 10 pack-years

               2. Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value

               3. Post-bronchodilator FEV1/FVC (forced vital capacity) <70%

        Exclusion Criteria:

          -  Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or
             antibiotics and/or hospitalization for in the 6 weeks prior to screening

          -  Patients who have had a respiratory tract infection within 6 weeks prior to screening

          -  Patients with concomitant pulmonary disease

          -  Patients with a history of asthma

          -  Patients with diabetes Type I or uncontrolled diabetes Type II

          -  Any patient with lung cancer or a history of lung cancer

          -  Patients with a history of certain cardiovascular comorbid conditions

        Other protocol-defined inclusion/exclusion criteria may apply
A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 and FF in Japanese Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone Furoate/GW642444 Inhalation Powder; Fluticasone Furoate Inhalation Powder
Intervention description: Fluticasone Furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks; Fluticasone Furoate inhalation powder inhaled orally once daily for 52 weeks
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: asthma; Fluticasone furoate; GW642444

Summary:

      The primary purpose of the study is to assess the safety and tolerability of 52-week teatment
      with fluticasone furoate/GW642444 inhalation powder once-daily and FF inhalation powder
      once-daily in Japanese adult subjects with asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Out patient at least 18 years of age

          -  Both genderds; females of childbearing potential must be willing to use birth control
             method

          -  A diagnosis of asthma at least 6 months prior to Screening

          -  A best FEV1 of at least 50% of the predicted nomal value at Screening

          -  Subjects have been receiving maintanance therapy for asthma, for at least 4 weeks
             prior to Screening

        Exclusion Criteria:

          -  History of life-threating asthma

          -  Respiratory infection or oral candidiasis

          -  Asthma exacerbation within 12 weeks

          -  Concurrent respiratory disease or other disease that would confound study
             participation or affect subject safety

          -  Allergies to study drugs, study drugs7 excipients, medications related to study drugs

          -  Taking another investigational medication or medication prohibited for use during this
             study
Sequential Use of Fluoxetine for Smokers With Elevated Depressive Symptoms
Condition: Major Depressive Disorder; Nicotine Dependence; Depression
MeSH terms: Tobacco Use Disorder; Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Fluoxetine; Dextrose
Intervention description: 20mg once daily for 16 weeks; Once daily for 16 weeks
Intervention MeSH terms: Fluoxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking Cessation; Tobacco Use Cessation; Antidepressants

Summary:

      The primary purpose of this study is to determine whether, among smokers with elevated
      depressive symptoms, sequential antidepressant pharmacotherapy with fluoxetine (20 mg) begun
      8 weeks prior to and extended throughout standard smoking cessation treatment with
      transdermal nicotine patch (ST-TNP) will result in superior short-and long-term smoking
      cessation outcomes compared to sequential pharmacotherapy with placebo medication combined
      with ST-TNP. The secondary aim of the study is to test the hypothesis that, among smokers
      with elevated depressive symptoms, sequential treatment with fluoxetine will result in lower
      levels of depressive symptoms and negative mood and higher levels of positive mood
      immediately prior to and throughout the course of smoking cessation treatment relative to the
      placebo condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Regular smoker for at least one year

          -  Currently smokes at least 10 cigarettes per day

          -  Elevated depressive symptoms

          -  Uses no other tobacco products

        Exclusion Criteria:

          -  Current Axis I disorder, including Major Depressive Disorder

          -  Psychoactive substance abuse or dependence (excluding nicotine dependence) within past
             year

          -  Current use of psychotropic medication

          -  Use of antidepressant medication within past 6 months

          -  Current suicidal risk

          -  History of significant medical illness, such as cardiovascular disease, neurological,
             gastrointestinal, or other systemic illness

          -  Pregnancy or breast feeding

          -  Use of nicotine replacement therapy or of any medication for smoking cessation not
             provided by the researchers during the quit attempt
Long-Term Extension Study of Pitavastatin in Patients With Primary Hypercholesterolemia or Combined Dyslipidemia
Condition: Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: Pitavastatin
Intervention description: Pitavastatin 4 mg once daily
Intervention MeSH terms: Pitavastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1355.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Kowa; Hypercholesterolemia; dyslipidemia; pitavastatin; NK-104; Hypercholesterolemia or combined dyslipidemia

Summary:

      This study is a long-term follow-up protocol for patients who participated in study
      NK-104-3.01EU or study NK-104-3.02EU.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients have completed 12 weeks of treatment in Study NK-104-301 (NCT00249249) or
             NK-104-302 (NCT00309777)

          -  Patients who have not developed any treatment emergent and, in the opinion of the
             investigator, related adverse event (AE) of clinical significance where the
             investigator is uncomfortable with continuing the patient on therapy with
             pitavastatin.

          -  Patients who have been following a fat and cholesterol restrictive diet.

        Exclusion Criteria:

          -  Any conditions which may cause secondary dyslipidemia should be reassessed at the
             beginning of the follow-up study.

          -  Uncontrolled diabetes mellitus should be reassessed at the beginning of the follow-up
             study.

          -  Abnormal pancreatic, liver, or renal function

          -  Abnormal serum ALAT/SGPT/ALT, ASAT/SGOT/AST, or creatine kinase (CK) above the
             pre-specified level

          -  Significant heart disease
A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
Condition: Parkinson's Disease Psychosis
MeSH terms: Parkinson Disease; Psychotic Disorders; Mental Disorders
Intervention: Pimavanserin tartrate (ACP-103)
Intervention description: Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
Intervention MeSH terms: Pimavanserin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 459.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Parkinson's Disease Psychosis

Summary:

      To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's
      disease psychosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has completed the treatment period of a previous blinded study of pimavanserin

          -  The subject is willing and able to provide consent

          -  Caregiver is willing and able to accompany the subject to all visits

        Exclusion Criteria:

          -  Subject has current evidence of a serious and or unstable cardiovascular, respiratory,
             gastrointestinal, renal, hematologic or other medical disorder

          -  Subject is judged by the Investigator to be inappropriate for the study
A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dulaglutide; Glimepiride; Placebo as Capsules; Placebo as SC Injection
Intervention description: Administered SC; Administered orally; Placebo for glimepiride is administered orally as one to three capsules daily.; Placebo for dulaglutide is administered as one SC injection.
Intervention MeSH terms: Glimepiride; Dulaglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 737.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe
      compared to glimepiride in participants with type 2 diabetes mellitus who have inadequate
      glycemic control with oral antihyperglycemic medication (OAM) or are OAM-naïve.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus

          -  OAM-naïve or have been taking OAM monotherapy for at least 3 months

          -  Glycosylated Hemoglobin (HbA1c) value of ≥7.0% to ≤10.5% for OAM-naïve participants or
             ≥6.5% to ≤10.0% for participants taking OAM monotherapy

          -  Adult men or adult non-pregnant, non-breastfeeding women

          -  Stable weight (±5%) ≥3 months prior to screening

          -  Body mass index (BMI) of ≥19.0 to ≤35.0 kilograms per square meter (kg/m^2)

        Exclusion Criteria:

          -  Have type 1 diabetes mellitus

          -  Have previously been treated with a glucagon-like peptide-1 (GLP-1) receptor agonist,
             GLP-1 analog, or any other incretin mimetic during the 3 months before screening

          -  Are currently taking dipeptidylpeptidase-IV (DPP-IV) inhibitor and thiazolidinediones
             (TZD) during the 3 months before screening

          -  Have gastric emptying abnormality

          -  Have cardiac disorder defined as unstable angina, myocardial infarction, coronary
             artery bypass graft surgery, percutaneous coronary intervention, heart failure,
             arrhythmia, transient ischemic attack, or stroke

          -  Have poorly controlled hypertension (systolic blood pressure above 160 millimeters of
             mercury [mmHg] or diastolic blood pressure above 95 mmHg)

          -  Have impaired liver function

          -  Have impaired kidney function

          -  Have history of chronic pancreatitis or acute pancreatitis

          -  Have a serum calcitonin ≥20 picogram/milliliter (pg/mL)

          -  Have a personal or family history of medullary C-cell hyperplasia, focal hyperplasia,
             carcinoma or multiple endocrine neoplasia type 2 (MEN 2)
Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin phosphate; Comparator: metformin hydrochloride
Intervention description: (1) sitagliptin 100mg tablet once daily (q.d.) for a 24-wk treatment period; (4) Metformin 500mg tablets once daily (q.d.) for a 24-wk treatment period.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1050.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No

Summary:

      A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used
      medication in patients with type 2 diabetes
    

Eligibility criteria:

        General Inclusion Criteria:

          -  Patient has type 2 diabetes mellitus (T2DM)

          -  Patient is inadequately controlled and not on treatment with insulin or oral
             antihyperglycemic therapy

        General Exclusion Criteria:

          -  Patient has a history of type 1 diabetes mellitus or history of ketoacidosis

          -  Patient was on antihyperglycemic therapy (insulin or oral) within the prior 4 months
Staccato Loxapine in Agitated Patients With Schizophrenia
Condition: Patients With Schizophrenia and Acute Agitation
MeSH terms: Psychomotor Agitation; Schizophrenia
Intervention: Inhaled loxapine 5 mg; Inhaled loxapine 10 mg; Inhaled placebo
Intervention description: Inhaled loxapine 5 mg; Inhaled loxapine 10 mg; Inhaled placebo
Intervention MeSH terms: Loxapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 344.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: schizophrenia, agitation, inhaled loxapine, ADASUVE

Summary:

      Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in
      schizophrenic patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adult patients with schizophrenia and acute agitation

        Exclusion Criteria:

          -  Agitation caused primarily by acute intoxication

          -  History of drug or alcohol dependence

          -  Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug
             administration
Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Nicotine Spray; Placebo
Intervention description: Nicotine Spray; Placebo to match nicotine spray
Intervention MeSH terms: Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1198.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of a novel nicotine product
      for continuous abstinence from smoking. Efficacy of product will be evaluated by assessments
      of self-reported abstinence, verified by exhaled carbon monoxide (CO) levels.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must be males or females 18-85 years of age who currently smoke cigarettes daily
        and are willing to stop smoking

        Exclusion Criteria:

        History of cardiovascular disease, stomach ulcer or diabetes unless physician's written
        approval is obtained.

        Use of other forms of tobacco/nicotine containing products other than cigarettes within 30
        days before baseline visit.

        Use of nicotine replacement therapies or other smoking cessation medicines/non-drug
        therapies within 30 days before the baseline visit.

        Pregnancy or intending to become pregnant.

        Hypersensitivity to the product, history of alcohol or substance abuse.
Ecopipam Treatment of Self-Injurious Behavior in Subjects With Lesch-Nyhan Disease
Condition: Lesch-Nyhan Disease; Self-injurious Behavior
MeSH terms: Lesch-Nyhan Syndrome; Self-Injurious Behavior
Intervention: Ecopipam; Placebo
Intervention description: Antagonist of the dopamine D1 receptor; Placebo for Ecopipam
Intervention MeSH terms: Ecopipam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 6 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Lesch Nyhan Disease; Self-Injury

Summary:

      The purpose of this research study is to gather scientific information about the
      effectiveness and safety of the study drug, Ecopipam (PSYRX 101), for the treatment of
      self-injurious behaviors when compared with the effectiveness and safety of placebo (inactive
      substance) in subjects with Lesch-Nyhan Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have classic LND as defined by (a) characteristic clinical syndrome
             (evidence of overproduction of uric acid, severe generalized dystonia, frequent and
             persistent self-injurious behavior (SIB), and cognitive impairment) and (b) laboratory
             confirmation for mutation of the HPRT gene or severe deficiency of the associated
             enzyme.

          -  Subjects must have a minimum combined score of 20 on the Behavior Problems Inventory
             (BPI) SIB subscales for frequency and severity as assessed by the caregiver.

          -  Subjects must have a minimum score of 4 on the Physician's Global Impression (PGI)
             severity scale.

          -  Subject must be ≥ 6 years old.

          -  Subjects must weigh > 10 kg.

        Exclusion Criteria:

          -  Subjects who are currently treated with medications for seizures.

          -  Subjects who are on neuroleptics or dopamine-depleting agents.

          -  Subjects with impaired renal function as defined by a serum creatinine >1.5 mg/dL.