bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Indacaterol in Patients With 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; Placebo to indacaterol
Intervention description: Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.; Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 416.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: chronic obstructive pulmonary disease; COPD; indacaterol

Summary:

      This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily
      (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

        • Male or female patients aged 40 years or over with moderate to severe chronic obstructive
        pulmonary disease (COPD) plus

          -  20 pack-year smoking history

          -  Signed informed consent

          -  Post-bronchodilator forced expiratory volume in 1 second )FEV1) ≥ 30% and < 80%
             predicted FEV1/FVC (forced vital capacity) < 70%

        Exclusion Criteria include:

          -  History of asthma

          -  Prior exposure to indacaterol

          -  Active cancer or history of cancer

          -  Patients with concomitant pulmonary disease

          -  Patients with diabetes Type I or uncontrolled diabetes Type II

          -  Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured
             at screening or randomization is prolonged

          -  Patients unable to successfully use a dry-powder inhaler device or perform spirometry
             measurements

        Other protocol-defined inclusion/exclusion criteria applied to the study.
Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
Condition: Healthy
MeSH terms: Hepatitis B
Intervention: HEPLISAV and/or Placebo; Engerix-B
Intervention description: Intramuscular (IM) injections on Week 0 and Week 4; placebo (saline) injection at Week 24; Intramuscular (IM) injections on Week 0, Week 4 and Week 24
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2452.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HBV vaccine; Hepatitis B vaccine; Hepatitis B; Hepatitis; HBV; Prevention & Control; Healthy; Healthy volunteers

Summary:

      The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency
      of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years
      of age
    

Eligibility criteria:

        Inclusion Criteria:

          -  be 40 - 70 years of age, inclusive

          -  be seronegative for hepatitis B surface antigen (HBsAg), antibody against hepatitis B
             surface antigen (anti-HBsAg), antibody against hepatitis B core antigen (anti-HBcAg),
             and human immunodeficiency virus (HIV)

          -  be in good health in the opinion of the investigator, based upon medical history,
             physical examination, and laboratory evaluation

          -  if female of childbearing potential, agree to consistently use a highly effective
             method of birth control from screening visit through the treatment phase, for up to 28
             days after the last injection

        Exclusion Criteria:

          -  if female of childbearing potential, is pregnant, breastfeeding, or planning a
             pregnancy

          -  has a history of or is considered by the investigator to be at high risk for recent
             exposure to HBV or HIV; for example, current intravenous drug use or has unprotected
             sex with known HBV/HIV positive partner

          -  has a known history of autoimmune disease

          -  has previously received any hepatitis B vaccine (approved or investigational)
Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder
Condition: Seizures
MeSH terms: Seizures; Epilepsy
Intervention: Cannabidiol Oral Solution
Intervention description: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Intervention MeSH terms: Cannabidiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Lennox-Gastaut syndrome; Dravet syndrome; Treatment-resistant seizures

Summary:

      This is a multicenter, open-label trial to assess the long-term safety and efficacy of
      Cannabidiol Oral Solution as adjunctive therapy for pediatric participants with
      treatment-resistant seizure disorders, including Lennox-Gastaut syndrome (LGS) or Dravet
      syndrome (DS). All participants have rolled over from previous trials: INS011-14-029
      (NCT02324673) and INS011-15-054 (NCT02551731).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed activities through Day 11 in INS011-14-029 or Part A (Visit 6) INS011-15-054

          -  Informed consent/assent (as applicable) was voluntarily provided by the participant
             and/or parent(s)/caregiver(s) in accordance with applicable laws, regulations, and
             local requirements

          -  Is medically stable with no anticipated changes in chronic medications in the opinion
             of the Investigator

          -  Continues to meet protocol-specified criteria for qualification and contraception,
             including treatment-resistant seizure disorder

          -  In the opinion of the Investigator, the subject and/or parent(s)/caregiver(s) are able
             to continue keeping accurate seizure diaries

        Exclusion Criteria:

          -  Inadequate supervision by parent(s)/caregiver(s)

          -  History or current use of dietary supplements, drugs or over-the counter medications
             outside protocol-specified parameters

          -  Signs, symptoms or history of any condition that, per protocol or in the opinion of
             the investigator, might compromise:

               1. the safety or well-being of the participant or study staff

               2. the safety or well-being of the participant's offspring (such as through
                  pregnancy or breast-feeding)

               3. the analysis of results
ESP Block VS TAP in Laparoscopic Hysterectomy
Condition: Hysterectomy
Intervention: Liposomal bupivacaine; bupivacaine, 0.125%
Intervention description: 20ml; 60ml
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: ESP Block Group
TAP Block Group
Masking: Double (Participant, Outcomes Assessor)
Masking description: Both the patients and the research staff doing assessments will be blinded to the randomization
Enrollment: 78.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the difference between two different pain control
      methods in patients who will be having a hysterectomy surgery. By collecting this data, we
      aim to show improved postoperative pain scores, decreased opioid needs, and decreased opioid
      side effects (nausea, sedation, ileus, urinary retention, respiratory depression).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing laparoscopic hysterectomy surgery at Indiana University Hospital

          -  ASA class 1, 2, 3 or 4

          -  Age 18 or older, female

          -  Desires Regional anesthesia for postoperative pain control

        Exclusion Criteria:

          -  History of substance abuse in the past 6 months.

          -  Patients on more than 30 mg morphine equivalents of opioids.

          -  Any physical, mental or medical conditions which in the opinion of the investigators,
             may confound quantifying postoperative pain resulting from surgery.

          -  Known allergy or other contraindications to the study medications (Acetaminophen,
             Gabapentin, Bupivacaine).

          -  Postoperative intubation.

          -  Any BMI greater than 40.0.
Filgrastim With or Without Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide
Condition: Refractory Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: plerixafor; filgrastim
Intervention description: Given SC; Given SC
Intervention MeSH terms: Plerixafor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This clinical trial studies filgrastim (G-CSF) with or without plerixafor in treating
      patients with multiple myeloma (MM) previously treated with lenalidomide. Giving
      colony-stimulating factors, such as G-CSF, and plerixafor helps stem cells move from the
      patient's bone marrow to the blood so they can be collected and stored
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of MM by International Myeloma Working Group Criteria

          -  In first or second complete or partial remission or stable refractory but not actively
             progressing myeloma according to the classifications provided by The Center for
             International Blood & Marrow Transplant Research

          -  Received at least 2 cycles of lenalidomide therapy

          -  Patients with MM scheduled to undergo stem cell harvest for possible allogeneic stem
             cell transplant (ASCT)

          -  At least 2 weeks since last exposure to lenalidomide

          -  Eastern Cooperative Oncology Group performance status of 0 or 1

          -  Prior to the start of mobilization:

               -  white blood cell count >/= 2.5 x 10^9/L

               -  absolute neutrophil count >/= 1.2 x 10^9/L

               -  platelet count >/=100 x 10^9/L

               -  creatinine clearance >/= 30mL/minute

          -  If childbearing potential, must either agree to complete abstinence from heterosexual
             intercourse or effective means of contraception during stem cell mobilization; female
             patients will undergo pregnancy test prior to stem cell mobilization therapy

        Exclusion Criteria:

          -  Had prior autologous or allogeneic transplantation

          -  Received pegfilgrastim within 3 weeks or G-CSF within 14 days of first dose of G-CSF
             for mobilization

          -  Failed previous hematopoietic stem cell collections or collection attempts

          -  Received radiation therapy to the pelvic area

          -  Received lenalidomide within 2 weeks of first dose of G-CSF for mobilization

          -  Had received experimental therapy within 4 weeks of enrolling in study

          -  Current or prior history of other malignancies, excluding basal cell carcinoma of the
             skin
Music vs Midazolam During Preop Nerve Block Placement
Condition: Anxiety; Peripheral Nerve Block
Intervention: music; Midazolam
Intervention description: patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff; patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed
Intervention MeSH terms: Midazolam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1
Masking: None (Open Label)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: midazolam

Summary:

      The purpose of this study is to determine if there are differences in anxiety scores, heart
      rate, blood pressure, and oxygen status when using sedation medication versus music while
      undergoing a peripheral nerve block before your surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are >18 years of age, who will give informed consent in receiving a
             peripheral nerve block in the preoperative bay for their primary anesthetic and/or for
             their postoperative pain control.

        Exclusion Criteria:

          -  significant psychiatric disorder such as generalized anxiety disorder, panic disorder,
             depression, psychosis, bipolar disorder; individuals who were incompetent to give
             informed consent; pregnant and/or breast feeding patients; any underlying
             coagulopathy, infection or other factors which would be a contraindication to
             receiving a peripheral nerve block; hypersensitivity to midazolam; and history of
             renal impairment. Patients who were extremely anxious (scores 50 and greater on the
             State Trait Anxiety Inventory-6 (STAI-6) tool) were also excluded from the study.
Sphenopalatine Nerve Block for Headache Tx360
Condition: Headache; Migraine
MeSH terms: Headache
Intervention: Bupivacaine; Placebo
Intervention description: Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion; Normal Saline Delivered by the Tx 360 Device to the Sphenopalatine Ganglion
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Headache; Migraine

Summary:

      The primary objective of this study is to evaluate the efficacy of sphenopalatine nerve block
      utilizing the Tx360 (device) to deliver an anesthetic agent (bupivacaine) and to assess the
      duration of the analgesia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  are 18 - 65 years of age

          -  present to emergency department (ED) triage with chief complaint of crescendo-onset
             anterior/frontal headache (affecting frontal, temporal, orbital, maxillary, and
             mandible region)

          -  have a normal neurological exams

        Exclusion Criteria:

          -  are less than 18 years old or greater than 65

          -  have any focal neurological dysfunction signs or symptoms

          -  have a posterior/occipital/cervicogenic source predominance of headache

          -  are febrile (oral temperature 37.7 C or 100 F) or signs of acute or chronic sinusitis,
             such as congestion, has been present more than 10 days, there is a high fever, the
             nasal mucus is an abnormal color, or complains of face pain or headaches

          -  have self treated with pain medication or anti-emetic 4 hours prior to arrival

          -  have a history of peripheral vascular disease, cancer, or HIV infection

          -  are known to be pregnant
Study of the Efficacy and Safety of Alirocumab (REGN727/SAR236553) in Combination With Other Lipid-modifying Treatment (LMT) (ODYSSEY OPTIONS I)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Alirocumab; Atorvastatin; Ezetimibe; Rosuvastatin; Placebo
Intervention description: Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.; Atorvastatin over-encapsulated tablets orally.; Ezetimibe over-encapsulated tablet orally.; Rosuvastatin over-encapsulated tablets orally.; Placebo for alirocumab and ezetimibe.
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Ezetimibe; Alirocumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 355.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, active-comparator, parallel-group study in patients at
      high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial
      hypercholesterolemia (heFH).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with screening (visit 1) LDL-C greater than or equal to 70 mg/dL with
             documented CVD, not adequately controlled with a daily dose of atorvastatin. OR

          2. Patients with screening (visit 1) LDL-C greater than or equal to 100 mg/dL at high
             risk for CVD who are not adequately controlled with a daily dose of atorvastatin.

        Exclusion Criteria:

          1. LDL-C greater than 250 mg/dL

          2. LDL-C less than 70 mg/dL at the screening visit in patients with history of documented
             CVD

          3. LDL-C less than 100 mg/dL at the screening visit in patients without history of
             documented CHD or non-CHD CVD, but with other risk factors

          4. TG greater than 400 mg/dL

          5. Homozygous FH (clinically or previous genotyping)

          6. Currently taking a statin that is not atorvastatin

          7. Currently taking Ezetimibe (EZE)

          8. Not on a stable dose of allowable lipid modifying treatments (LMT)

        (The inclusion/ exclusion criteria provided above is not intended to contain all
        considerations relevant to a patient's potential participation in this clinical trial).
Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.
Condition: Influenza Virus
MeSH terms: Influenza, Human
Intervention: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV); Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)
Intervention description: 1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months; 1 or 2 doses (naïve / non-naive subjects) 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10644.0
Sex: All
Minimum age: 6 Months
Maximum age: 71 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Influenza; children

Summary:

      Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus
      Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to <72 Months
      of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere
      influenza season.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children, males and females, healthy or at high risk of complications from influenza,
             between ≥6 months to <72 months of age

          -  Documented consent provided by the subject's parent(s)/legal guardian(s)

          -  Subjects and/or subject's parent(s)/legal guardian(s) able to comply with all study
             procedures.

        Exclusion Criteria:

          -  Children with history of allergy to vaccine components.

          -  Additional eligibility criteria may be discussed by contacting the site
Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
Condition: Dental Plaque
MeSH terms: Dental Plaque
Intervention: Fluoride; Triclosan, fluoride; Chlorhexidine Gluconate
Intervention description: Brush half mouth twice daily for four days.; Brush twice daily; Rinse mouth twice a day
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Triclosan; Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral
      rinse
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be aged 18 to 65 years inclusive

          -  Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present

          -  Give written informed consent

          -  Be in good general health

          -  No known history of allergy to personal care/consumer products or their ingredients,
             relevant to any ingredients in the test products as determined by the dental/medical
             professional monitoring the study

          -  If of childbearing potential and on birth control (Diaphragm, Birth Control Pills,
             Birth Control Implants, IUD (Intrauterine device), condoms)

        Exclusion Criteria:

          -  Medical condition which requires pre-medication (antibiotics) prior to dental

          -  Visits/procedures

          -  Allergy to chlorhexidine

          -  Advanced periodontal disease (gum disease)

          -  5 or more decayed, untreated dental sites (cavities)

          -  Diseases of the soft or hard oral tissues (gums or palate)

          -  Orthodontic appliances that interfere with plaque rating

          -  Abnormal salivary function

          -  Use of drugs that can affect currently salivary flow or production

          -  Use of antibiotics one (1) month prior to or during this study

          -  Use of any over the counter medications other than analgesics (i.e. aspirin,
             ibuprofen, acetaminophen,naproxyn)

          -  Pregnant or breastfeeding.

          -  Participation in another research study in the month preceding this study

          -  Allergic to common toothpaste or mouth rinse ingredients.

          -  Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) or
             individuals who have a high risk of infection from other causes