bioihbjkbjnl/mcl2 huggingface dataset:
Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)
Condition: Pneumococcal Infection
MeSH terms: Pneumococcal Infections
Intervention: pneumococcal 23v polysaccharide vaccine
Intervention description: Duration of Treatment: Single vaccination on Day 1
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 143.0
Sex: All
Minimum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine that revaccination of Pneumococcal Vaccine is well
      tolerated and produces an immune response in older adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal or negative urine pregnancy test if female

          -  No fever on the day of vaccination

        Exclusion Criteria:

          -  History of allergy to vaccine components

          -  History of pneumococcal disease

          -  Received any live virus vaccination within 4 weeks prior to study start

          -  Received any inactivated vaccination within 7 days prior to study start

          -  Received any blood products within 5 months prior to study start

          -  Participated in an investigational drug or vaccine study in the past 30 days

          -  Received immunosuppressive therapy

          -  Patient has an immune deficiency
A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol 150 μg; Tiotropium 18 μg; Placebo to indacaterol; Placebo to tiotropium
Intervention description: Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).; Tiotropium 18 μg was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).; Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).; Placebo to tiotropium was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 1598.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; indacaterol; beta 2 agonist; tiotropium

Summary:

      This study compared the lung effects of indacaterol to those of tiotropium in patients with
      moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.
    

Eligibility criteria:

        Inclusion Criteria:

        - Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic
        Obstructive Lung Disease (GOLD) Guidelines, 2007) and:

          -  a) Smoking history of at least 10 pack-years

          -  b) Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of
             the predicted normal value

          -  c) Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

        Exclusion Criteria:

          -  Patients who have received systemic corticosteroids or antibiotics and/or was
             hospitalized for a COPD exacerbation 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 applied to the study.
Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)
Condition: Hypercholesterolemia; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Hypercholesterolemia; Syndrome
Intervention: ezetimibe (+) simvastatin; Comparator: atorvastatin calcium; Comparator: Placebo (unspecified)
Intervention description: Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg or 10/40 mg.; Atorvastatin will be supplied in 10mg, 20mg and 40mg tablets.
Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.; Atorvastatin Placebo will be supplied in 10mg, 20mg and 40mg tablets.
ezetimibe/simvastatin Placebo will be supplied in 10/20mg and 10/40mg combination tablets.
Each patient will receive 1 active treatment dose & 2 Placebo doses at randomization according to a predetermined partial blinding schedule to reduce the number of pills from 5 to 3 per patient per day for 6 weeks.
Intervention MeSH terms: Atorvastatin; Simvastatin; Ezetimibe; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1143.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      A 6-week clinical trial in patients with metabolic syndrome and hypercholesterolemia at high
      risk for coronary heart disease to study the effects of ezetimibe/simvastatin and
      atorvastatin on lipids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 to 79 years of age with metabolic syndrome and hypercholesterolemia at
             high risk for coronary heart disease (CHD) with LDL-C above 70 mg/dL or 100 mg/dL
             depending on their CHD risk category

        Exclusion Criteria:

          -  A condition which, in the opinion of the investigator, pose a risk to the patient or
             interfere with participating in the study

          -  Patient is likely to be greater than 20% noncompliant in taking study medications

          -  Patients with chronic medical conditions

          -  Patients with unstable doses of medications

          -  Pregnant or lactating women, women intending to become pregnant

          -  Patient is currently receiving prescription therapy with statins or other
             lipid-altering medications

          -  Patient with Type 1 or Type 2 diabetes mellitus that is poorly controlled, newly
             diagnosed, or is taking new or recently adjusted antidiabetic pharmacotherapy (with
             the exception of +/- 10 units of insulin)
Clinical Study to Evaluate Dental Plaque
Condition: Gingival Diseases
MeSH terms: Dental Plaque; Gingival Diseases
Intervention: Triclosan/Fluoride; Fluoride/triclosan
Intervention description: Brush twice daily for 3 weeks; Brush daily for 3 weeks
Intervention MeSH terms: Triclosan; Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 20 Years
Maximum age: 51 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3
      week brushing regiment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female volunteers at least 20 - 51 years of age

          -  Good general health

          -  Must sign informed consent form

          -  Minimum of 15 natural uncrowned teeth (excluding third molars) must be present

          -  No history of allergy to personal care consumer products, or their ingredients,
             relevant to any ingredient in the test products as determined by the dental/medical
             professional monitoring the study

        Exclusion Criteria:

          -  Subjects unable or unwilling to sign the informed consent form

          -  Medical condition which requires pre-medication prior to dental visits/procedures

          -  Moderate or advanced periodontal disease or heavy dental tartar (calculus)

          -  5 or more decayed untreated dental sites at screening (cavities)

          -  Other disease of the hard or soft oral tissues.

          -  Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).

          -  Use of medications that are currently affecting salivary function

          -  Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1

          -  Pregnant or nursing women

          -  Participation in any other clinical study within 1 week prior to enrollment into this
             study

          -  Use of tobacco products

          -  Subjects who must receive dental treatment during the study dates

          -  Current use of Antibiotics for any purpose

          -  Presence of an orthodontic appliance which interferes with plaque scoring

          -  History of allergy to common toothpaste ingredients

          -  History of allergy to arginine (amino acid)

          -  Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Tirzepatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 478.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glucose-dependent insulinotropic polypeptide (GIP); glucagon-like peptide-1 (GLP-1); GIP/GLP-1 dual receptor agonist; T2DM

Summary:

      The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo
      in participants with type 2 diabetes not under control with diet and exercise alone. The
      study will last approximately 47 weeks and may include about 15 visits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been diagnosed with type 2 diabetes mellitus (T2DM).

          -  Are naïve to diabetes injectable therapies and have not used any oral
             antihyperglycemic medications (OAMs) during the 3 months preceding screening.

          -  Have HbA1c between ≥7.0% and ≤9.5%.

          -  Be of stable weight (± 5%) for at least 3 months before screening.

          -  Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening.

        Exclusion Criteria:

          -  Have type 1 diabetes mellitus.

          -  Have had chronic or acute pancreatitis any time prior to study entry.

          -  Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative
             diabetic retinopathy requiring acute treatment.

          -  Have disorders associated with slowed emptying of the stomach, or have had any stomach
             surgeries for the purpose of weight loss.

          -  Have an estimated glomerular filtration rate <30 mL/minute/1.73 m².

          -  Have had a heart attack, stroke, or hospitalization for congestive heart failure in
             the past 2 months.

          -  Have a personal or family history of medullary thyroid carcinoma or personal history
             of multiple endocrine neoplasia syndrome type 2.

          -  Have been taking weight loss drugs, including over-the-counter medications during the
             last 3 months.
Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: LDV/SOF; SOF; RBV
Intervention description: 90/400 mg FDC tablet administered orally once daily; 400 mg tablet administered orally once daily; Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, > 60 kg to ≤ 80 kg = 800 mg, and > 80 kg = 1000 mg)
Intervention MeSH terms: Sofosbuvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 239.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the antiviral efficacy of therapy with
      ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) and to evaluate the safety and
      tolerability of LDV/SOF FDC and sofosbuvir (SOF) + ribavirin (RBV) in participants with
      chronic genotype 2 hepatitis C virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic genotype 2 HCV-infected males and non-pregnant/non-lactating females

          -  Aged 20 years or older

          -  Treatment naive or treatment experienced

          -  At least 20 subjects will have Child-Pugh-A compensated cirrhosis. In Cohort 2,
             participants must be ineligible or intolerant of RBV.

        Key Exclusion Criteria:

          -  Previous exposure to an NS5A or NS5B inhibitor

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

          -  Pregnant or nursing female or male with pregnant female partner

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212)
Condition: Asthma
MeSH terms: Asthma
Intervention: Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI; Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI
Intervention description: Two oral inhalations per dose; Two oral inhalations per dose
Intervention MeSH terms: Mometasone Furoate; Formoterol Fumarate; Mometasone Furoate, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety, tolerability & effectiveness of 2
      strengths of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in the
      treatment of persistent asthma in adults & adolescents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of asthma of at least 6 months duration

          -  Current use of a medium or high daily dose of an inhaled corticosteroid (ICS) (alone
             or in combination with a long-acting beta agonist [LABA]) for at least 6 weeks prior
             to Screening AND must be on a stable asthma regimen (daily dose unchanged) for at
             least 2 weeks prior to Screening

          -  Agrees to change asthma therapy (if changing asthma therapy poses no inherent risk)

          -  If female of reproductive potential, agrees to remain abstinent or use 2 acceptable
             methods of birth control during study participation. Acceptable methods of birth
             control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive
             sponge, condom, vasectomy, hormonal contraceptive

        Exclusion Criteria:

          -  Treatment in the emergency room (for a severe asthma exacerbation), or admitted to the
             hospital for management of airway obstruction within previous 3 months

          -  Any prior ventilator support for respiratory failure secondary to asthma,

          -  Upper or lower respiratory tract infection (viral or bacterial) within previous 2
             weeks

          -  History of a medical condition that, in the investigator's opinion, may interfere with
             study participation,

          -  History of smoking within previous year or a cumulative smoking history of more than
             10 pack-years

          -  Known allergy to or intolerance of ICSs, LABAs, or any of the ingredients included in
             the study medications

          -  History of use of illicit drugs

          -  Inability to correctly use an oral MDI

          -  Pregnant, breastfeeding or plans to become pregnant during study
Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: MP-424; Ribavirin; Peginterferon Alfa-2b; Ribavirin; Peginterferon Alfa-2b
Intervention description: 750 mg every 8 hours for 12 weeks; 600 - 1000 mg/day based on body weight for 24 weeks; 1.5 mcg/kg/week for 24 weeks; 600 - 1000 mg/day based on body weight for 48 weeks; 1.5 mcg/kg/week for 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b; Interferon-alpha
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 189.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C; Protease Inhibitor; Telaprevir; Peginterferon Alfa-2b; Ribavirin

Summary:

      This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b
      (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genotype 1, chronic hepatitis C

          -  Treatment-naïve (patient who has received no previous interferon based treatment for
             hepatitis C)

          -  Able and willing to follow contraception requirements

        Exclusion Criteria:

          -  Cirrhosis of the liver or hepatic failure

          -  Hepatitis B surface antigen-positive or HIV antibodies-positive

          -  History of, or concurrent hepatocellular carcinoma

          -  History of, or concurrent depression, schizophrenia; or suicide attempt in the past

          -  Pregnant, lactating, or suspected pregnant patients, or male patients whose female
             partner is pregnant
Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)
Condition: Opioid-induced Bowel Dysfunction
MeSH terms: Intestinal Diseases; Gastrointestinal Diseases; Opioid-Induced Constipation
Intervention: Lubiprostone; Placebo
Intervention description: 24 mcg administered orally twice daily (BID); Matching placebo, 0 mcg administered orally twice daily (BID)
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Care provider and outcomes assessor were also blinded for this double-blind trial.
Enrollment: 439.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone
      administration in subjects with Opioid-induced Bowel Dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

        A patient can be considered for eligibility to participate if he/she:

          -  Has been consistently treated for chronic, noncancer-related pain with any oral,
             transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to
             screening

          -  Is diagnosed with OBD

          -  Is capable of utilizing an electronic diary to report daily spontaneous bowel
             movements (SBMs)

          -  Is willing to continue opioid therapy and discontinue the use of laxatives, stool
             softeners, and other concomitant medications affecting gastrointestinal motility
             throughout the study

        Exclusion Criteria:

        A patient cannot be considered for eligibility to participate if he/she:

          -  Uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical
             bowel obstructions, bowel disorders, and constipation not arising from opioid use, but
             instead attributable to dietary, neurologic, congenital, or endocrine disorders,
             scleroderma, and/or for the management of drug addiction
A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Bilastine Ophthalmic Solution 0.6%; Ketotifen Ophthalmic Solution 0.025% (Zaditen); Vehicle of Bilastine Ophthalmic Solution
Intervention description: 1 drop in each eye at 2 separate times during an 8 day period.; 1 drop in each eye at 2 separate times during an 8 day period.; 1 drop in each eye at 2 separate times during an 8 day period.
Intervention MeSH terms: Ketotifen; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 228.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of Bilastine ophthalmic solution 0.6% compared to vehicle and
      Zaditen (Ketotifen ophthalmic solution 0.025%) for the treatment of the signs and symptoms of
      allergic conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  be at least 18 years old

          -  be willing and able to avoid all disallowed medications and contact lenses

          -  must have a pregnancy test if of childbearing potential

          -  must be able to read an eye chart from 10 feet away

        Exclusion Criteria:

          -  must not have any allergies to the study medications

          -  must not have any ocular or non ocular condition that investigator feels will
             interfere with study parameters

          -  must not have used immunotherapy in the last 2 years

          -  must not have used an investigational drug or device in the past 30 days or
             concurrently enrolled in another investigational trial