bioihbjkbjnl/mcl2 huggingface dataset:
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.
Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Intervention: Lubiprostone; Placebo
Intervention description: 24 mcg administered orally BID; 24 mcg administered orally BID
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 552.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule
      formulations of lubiprostone, as compared to placebo, when administered orally in
      participants with Chronic Idiopathic Constipation (CIC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Either has medically-confirmed diagnosis of chronic constipation (per Rome III), or
             meets the diagnosis as confirmed using the Rome III constipation module questionnaire
             during the Screening period.

          -  Is male or female, 18 or older years of age

          -  Should be on stable dose of fiber supplement or a concomitant medication for the
             indication of lowering blood pressure

        Exclusion Criteria:

          -  Has any gastrointestinal (GI) condition, other than constipation, affecting GI
             motility or defecation

          -  Is unable to eat or drink, take oral medications, or to hold down oral medications due
             to vomiting
Safety and Immunogenicity of Recombinant Hepatitis B Vaccine Sci-B-Vac® Compared to Engerix-B®
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Sci-B-Vac®; Engerix-B®
Intervention description: Sci-B-Vac® vaccine-10 μg of HBsAg, intramuscular injection of 10 μg/ml; Engerix-B® vaccine-20 μg of HBsAg, intramuscular injection of 20 μg/ml
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Sci-B-Vac®; Prophylactic vaccine; HepB vaccines; Phase 3; pre-S1; pre-S2; Surface antigen

Summary:

      This study was a comparative, randomized, double-blind clinical study of the efficacy and
      safety of Sci-B-Vac® (10 μg dose) and the Engerix-B® (20 μg dose) vaccines in two parallel
      groups of hepatitis B-naive healthy adult subjects in Russia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Availability of written Informed Consent to participate in the study from the subject.

          2. Male or female between 18 and 45 years old without previous contact with hepatitis B
             virus (HBV).

          3. Good health condition based on full physical examination.

          4. Normal values of laboratory biochemical blood tests.

          5. Seronegative with respect to anti-HBs (surface) antibodies, anti-HBc (core)
             antibodies, and HBs Antigen (HBsAg) on screening.

          6. Not pregnant and not breast-feeding.

          7. For men and women of reproductive age: consent for use of an effective contraception
             method, for example, an intrauterine device, oral contraceptive, hypodermic implant or
             double barrier method (a condom with contraceptive sponge or contraceptive
             suppository) throughout the entire study.

        Exclusion Criteria:

          1. Congenital or inherited immunodeficiency disorder in family history.

          2. Information of a serious blood disorder, cardiac disorder, or tumour.

          3. Current use of any medication that could alter immune reactivity.

          4. Infection with HBV at the present time or in the past, confirmed by HBV markers test.

          5. Anaphylaxis or severe allergy, or atopy, history of alcoholism or drug abuse.

          6. Pregnancy and breast-feeding.
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
Condition: Acute Otitis Externa
MeSH terms: Otitis; Otitis Externa
Intervention: DF289 plus DF277; DF289; DF277
Intervention description: 1 vial into the affected ear twice daily for 7 days; 1 vial into the affected ear twice daily for 7 days; 1 vial into the affected ear twice daily for 7 days
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 493.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if a combination of an antibiotic plus a
      corticosteroid is safe and effective in treating AOE
    

Eligibility criteria:

        Inclusion Criteria:

          -  Uncomplicated AOE of less tan 21 days, defined as a total symptom score of at least 2
             for otalgia, 2 for edema and 1 for otorrhea

          -  Brighton Grading of II or III

          -  Culture-based diagnosis of acute bacterial otitis externa

          -  Willingness to refrain from swimming through end of the study

        Exclusion Criteria:

          -  Previous episode of AOE within 4 weeks prior to enrollment, or 2 or more episodes of
             AOE within 6 months prior to the enrollment.

          -  Tympanic membrane perforation

          -  Any condition or situation likely to cause the patient to be unable or unwilling to
             comply with study treatment or attend all study visits

          -  Any condition in the patient or parent/guardian that, in the judgment of the principal
             investigator, could compromise patient safety, limit the patient's ability to complete
             the study, and/or compromise the objectives of the study
Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure
Condition: Thrombocytopenia
MeSH terms: Thrombocytopenia
Intervention: Avatrombopag 60 mg
Intervention description: Oral avatrombopag administered once daily for 5 days prior to procedure.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: low platelet count; ITP

Summary:

      Phase 3b open-label, multicenter study to evaluate the safety and efficacy of avatrombopag in
      subjects with thrombocytopenia scheduled for operations to critical sites or operations with
      a high risk of bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women greater than or equal to 18 years of age;

          -  A mean baseline platelet count between:

               -  50 × 10^9/L and <100 × 10^9/L for non-chronic liver disease participants

               -  50 × 10^9/L and <75 × 10^9/L for participants with chronic liver disease;

          -  Participant is scheduled to undergo operations to critical sites (eg, eye surgery,
             neurosurgery) or operations with a high risk of bleeding (eg, major abdominal
             surgery), or, in the opinion of the Investigator, would otherwise require a
             pre-operative platelet transfusion to prevent bleeding

        Exclusion Criteria:

          -  Participant with a history of arterial or venous thrombosis within 6 months of
             baseline;

          -  Participant with known portal vein blood flow velocity rate <10 cm/second or previous
             portal vein thrombosis within 6 months of baseline;

          -  Participant plans to have a platelet transfusion or plans to receive blood products
             containing platelets within 7 days of the Baseline Visit;

          -  Use of erythropoietin-stimulating agents;

          -  Participant has a known medical history of genetic prothrombotic syndromes; or

          -  Participant has abnormal hemoglobin levels or prothrombin time/international
             normalized ratio
A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-809; Placebo; VX-770
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 206.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects
      aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF
      transmembrane conductance regulator (CFTR) mutation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who weigh ≥15 kg without shoes a the Screening Visit

          -  Subjects with confirmed diagnosis of CF at the Screening Visit.

          -  Subjects who are homozygous for the F508del CFTR mutation

          -  Subjects with ppFEV1 of ≥70 percentage points adjusted for age, sex, and height

          -  Subjects with a screening LCI2.5 result greater than or equal to 7.5

        Exclusion Criteria:

          -  History of any comorbidity reviewed at the Screening Visit that, in the opinion of the
             investigator, might confound the results of the study or pose an additional risk in
             administering study drug to the subject.

          -  Any clinically significant laboratory abnormalities at the Screening Visit that would
             interfere with the study assessments or pose an undue risk for the subject

          -  Clinically significant abnormalities in hemoglobin, liver function, or renal function
             at the Screening Visit.

          -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in
             therapy for pulmonary disease within 28 days before Day 1

          -  History of solid organ or hematological transplantation at the Screening Visit
A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation
Condition: Infertility
MeSH terms: Infertility
Intervention: highly purified human chorionic gonadotropin; recombinant human chorionic gonadotropin
Intervention MeSH terms: Chorionic Gonadotropin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 176.0
Sex: Female
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: No

Summary:

      This trial is investigating the efficacy and safety of highly purified human chorionic
      gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of
      final follicular maturation in women undergoing controlled ovarian stimulation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pre-menopausal females between the ages of 18 and 39 years

          -  Documented history of infertility

          -  Body mass index (BMI) between 17.5 and 32.0 kg/m2

          -  Regular menstrual cycles

        Exclusion Criteria:

          -  Known endometriosis stage III and IV

          -  Known polycystic ovarian syndrome (PCOS)

          -  History of recurrent miscarriage

          -  History of more than three previous controlled ovarian stimulation cycles
Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Placebo; Idalopirdine
Intervention description: Once daily, matching placebo capsules, orally; Once daily, encapsulated tablets, orally
Intervention MeSH terms: (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 734.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      To establish efficacy of idalopirdine as adjunctive therapy to acetylcholinesterase
      inhibitors (AChEIs) for symptomatic treatment of patients with mild-moderate Alzheimer's
      disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has a knowledgeable and reliable caregiver.

          -  The patient is an outpatient.

          -  The patient has probable AD.

          -  The patient has mild to moderate AD.

          -  Stable treatment with an AChEI.

          -  The patient, if a woman, must have had her last natural menstruation ≥24 months prior
             to baseline, OR be surgically sterile.

          -  The patient, if a man, agrees to protocol-defined use of effective contraception if
             his female partner is of childbearing potential, OR must have been surgically
             sterilised prior to the screening visit.

        Exclusion Criteria:

          -  The patient has evidence of any clinically significant neurodegenerative disease, or
             other serious neurological disorders other than AD.

          -  The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition,
             Text Revision (DSM-IV-TR) Axis I disorder other than AD.

          -  The patient has evidence of clinically significant disease.

          -  The patient's current AChEI therapy is likely to be interrupted or discontinued during
             the study.

          -  The patient is currently receiving memantine or has taken memantine within 2 months
             prior to screening.

        Other inclusion and exclusion criteria may apply.
A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Condition: Geographic Atrophy
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: Lampalizumab; Sham Comparator
Intervention description: 10 mg dose of lampalizumab administered intravitreally.; A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 975.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study is a Phase III, double-masked, multicenter, randomized, sham injection-controlled
      study evaluating the efficacy and safety of lampalizumab administered by intravitreal
      injections in participants with geographic atrophy (GA) secondary to age-related macular
      degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants aged greater than or equal to (>/=) 50 years

          -  Well demarcated area(s) of Geographic Atrophy (GA) secondary to Age-Related Macular
             Degeneration (AMD) with no evidence of prior or active choroidal neovascularization
             (CNV) in both eyes

        Exclusion Criteria:

        Ocular Exclusion Criteria (Study Eye):

          -  History of vitrectomy surgery, submacular surgery, or other surgical intervention for
             AMD

          -  Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein
             occlusion, and proliferative diabetic retinopathy

          -  Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection,
             anti-angiogenic drugs, anti-complement agents, or device implantation)

        Ocular Exclusion Criteria (Both Eyes):

          -  GA in either eye due to causes other than AMD

          -  Previous treatment with eculizumab, lampalizumab, and/or fenretinide
Study of OTO-104 in Subjects With Unilateral Meniere's Disease
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Intervention: OTO-104; Placebo
Intervention description: Single intratympanic injection of 12 mg OTO-104; Single intratympanic injection of placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 166.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Meniere's Disease; Vertigo

Summary:

      The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of
      Meniere's disease.
    

Eligibility criteria:

        Inclusion Criteria includes, but is not limited to:

          -  Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of
             Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo
             for the 2 months prior to the study lead-in period.

          -  Subject has experienced active vertigo during the lead-in period.

          -  Subject has documented asymmetric sensorineural hearing loss.

          -  Subject agrees to maintain their current treatments for Meniere's disease while
             on-study.

        Exclusion Criteria includes, but is not limited to:

          -  Subject is pregnant or lactating.

          -  Subject has a history of immunodeficiency disease.

          -  Subject has a history of previous endolymphatic sac surgery.

          -  Subject has a history of previous use of intratympanic (IT) gentamicin in the affected
             ear.

          -  Subject has a history of tympanostomy tubes with evidence of perforation or lack of
             closure.

          -  Subject has experienced an adverse reaction to IT injection of steroids.

          -  Subject has used an investigational drug or device in the 3 months prior to screening.

          -  Subject has previously been randomized to a trial of OTO-104.
A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: EM-100; Zaditor®; Vehicle
Intervention description: Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.; Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.; Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the
      treatment of ocular itching.
    

Eligibility criteria:

        Inclusion Criteria:

          -  be at least 18 years old

          -  have a positive history of allergic conjunctivitis and positive skin test reaction to
             allergens

          -  be willing to avoid disallowed medications for the appropriate washout period and
             throughout the trial

          -  be willing to avoid contact lens use

          -  be willing to have a pregnancy test

          -  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 an investigational drug or device in the past 30 days or currently
             be enrolled in another investigational trial