bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella
Intervention: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live; Comparator: Varivax; Comparator: M-M-R II
Intervention description: A Single 0.5 mL subcutaneous injection at Day 0; A Single 0.5 mL subcutaneous injection at Day 0; A Single 0.5 mL subcutaneous injection at Day 0
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3927.0
Sex: All
Minimum age: 12 Months
Maximum age: 23 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will compare three consistency lots of ProQuad to each other as well as to M-M-R
      II and Varivax, administered concomitantly at different injection sites, with respect to
      immunogenicity, safety, and tolerability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good health

          -  Negative clinical history of measles, mumps, rubella, varicella, and zoster

        Exclusion Criteria:

          -  Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or
             in combination

          -  Any immune impairment or deficiency

          -  Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to
             vaccination

          -  Vaccination with an inactive vaccine with in the past 14 days

          -  Vaccination with a live vaccine within the past 30 days
A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec/insulin aspart; biphasic insulin aspart 30
Intervention description: Injected subcutaneously twice daily. Dose was individually adjusted.; Injected subcutaneously twice daily. Dose was individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 424.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia. The aim of this clinical trial is to compare NN5401 (insulin
      degludec/insulin aspart (IDegAsp)) with biphasic insulin aspart (BIAsp) 30 in patients with
      type 2 diabetes not optimally controlled on once or twice daily insulin with or without
      metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 18 years of age (at least 20 years for Japan)

          -  Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months

          -  Subject on basal human or analogue insulin, once daily (OD) or twice daily (BID) with
             or without metformin for at least 3 months or subject on premixed human or analogue
             insulin or self-mixed insulin regimen, containing 20-40% fast/rapid-acting component,
             OD or BID, with or without metformin, for at least 3 months

          -  HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis

          -  Body mass index (BMI) maximum 35.0 kg/m^2

        Exclusion Criteria:

          -  Treatment with oral antidiabetic drugs (OADs) (except metformin) within the last 8
             weeks prior to Visit 1

          -  Treatment with thiazolidinediones (TZDs) or glucagon like peptide 1 (GLP-1) receptor
             agonists within 3 months prior to Visit 1

          -  Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke;
             decompensated heart failure New York Heart Association (NYHA) class III or IV;
             myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or
             angioplasty

          -  Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least
             180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)

          -  Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
             contraceptive measures according to local requirements

          -  Cancer and medical history of cancer (except basal cell skin cancer or squamous cell
             skin cancer)
An Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing Mutations
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Ivacaftor
Intervention description: Subjects will be treated with ivacaftor for 6 months and followed for 7 months and will undergo assessments along the way to measure sweat chloride and sputum amounts.
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This postmarketing N of 2 study is designed to evaluate the efficacy and safety of open-label
      ivacaftor treatment in two sisters with cystic fibrosis and pancreatic sufficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects are >18 years of age and able to provide informed consent.

          -  Subjects reside in the US and are willing to be treated with ivacaftor.

          -  Subjects have the splicing mutation of interest.

          -  Subjects are willing and able to perform requirements of the study.

        Exclusion Criteria:

          -  There are no relevant exclusion criteria for this n-of-2 study.
A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.
Intervention description: Each subject will subcutaneously self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This trial assesses the safety of TEV-48125 when subcutaneously self-administered in Japanese
      migraine patients using an autoinjector (AI) at home. Each subject will subcutaneously
      self-administer TEV 48125 at 225 mg/1.5 mL (150 mg/mL) once monthly for a total of 2 doses.
      The first dose will be self-administered at the trial site under the supervision of the
      investigator and the second dose will be self-administered at home.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a history of migraine (according to the ICHD-3 criteria) diagnosis for ≥12
             months prior to giving informed consent.

          -  Patient fulfills any of the migraine criteria(according to the ICHD-3 criteria) on ≥4
             days in baseline information collected during the 28-day screening period

        Exclusion Criteria:

          -  History of hypersensitivity reactions to injected proteins, including monoclonal
             antibodies

          -  Prior exposure to a monoclonal antibody targeting (CGRP) pathway meeting the following
             conditions:

               -  Less than 5 months has passed since the final administration of AMG334, ALD304,
                  or LY2951742.

               -  Less than 1 year has passed since the final administration of TEV-48125
Symbicort Rapihaler Therapeutic Equivalence Study
Condition: Bronchial Asthma
MeSH terms: Asthma
Intervention: Symbicort Turbuhaler; Symbicort pMDI; Pulmicort Turbuhaler
Intervention description: Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily; Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily; Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
Intervention MeSH terms: Budesonide; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 742.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Asthma; Symbicort

Summary:

      The purpose of the this study is to evaluate the efficacy and safety of 2 actuations
      Symbicort®pMDI® 40/2.25 μg twice daily compared with1 inhalation Symbicort Turbuhaler® 80/4.5
      μg twice daily and 1 inhalation Pulmicort®Turbuhaler® 100 μg twice daily for 6 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Asthma clinically diagnosed since at least 6 months.

          -  Lung function values measured ≥ 50% and ≤ 90% of predicted normal.

          -  Patients with reversible airway obstruction Daily use of inhaled steroids (any brand)
             for >3 months.

        Exclusion Criteria:

          -  Use of oral, rectal or parenteral steroids within 30 days prior to start of study.

          -  Respiratory infection affecting the asthma, as judged by the investigator, within 30
             days prior to start of randomised treatment.

          -  Any significant disease or disorder which, in the opinion of the investigator, may
             either put the patient at risk because of participation in the study, or may influence
             the results of the study or the patient's ability to participate in the study.
DE-111 Against Tafluprost Ophthalmic Solution 0.0015% Alone and Concomitant Use of Tafluprost Ophthalmic Solution 0.0015% Plus Timolol Ophthalmic Solution 0.5%
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: DE-111 ophthalmic solution; Tafluprost ophthalmic solution 0.0015%; Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%
Intervention MeSH terms: Timolol; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 489.0
Sex: All
Minimum age: 20 Years
Keywords: Primary open angle glaucoma or ocular hypertension

Summary:

      DE-111 ophthalmic solution will be evaluated for superiority in comparison with Tafluprost
      0.0015% ophthalmic solution, or for non-inferiority in comparison with Tafluprost 0.0015% and
      Timolol ophthalmic solution 0.5% used concomitantly, in IOP(intraocular pressure) -lowering
      effect in primary open-angle glaucoma or ocular hypertension patients, in a multicenter,
      randomized, double-masked, parallel-group comparison study. Safety will be compared and
      evaluated as well.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with primary open angle glaucoma or ocular hypertension

          -  Provided signed, written informed consent

          -  20 years of age and older

          -  If a subject is a female of childbearing potential, she must utilize reliable
             contraceptive throughout the study, and must have a negative urine pregnancy test
             prior to enrollment into this study.

        Exclusion Criteria:

          -  Females who are pregnant, nursing or planning a pregnancy, or females of childbearing
             potential who are not using a reliable method of contraception.

          -  Presence of any abnormality or significant illness that could be expected to interfere
             with the study.
Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation
Condition: Pain Management, Cervical Preparation
MeSH terms: Dilatation, Pathologic
Intervention: Lidocaine Gel (2%); Lidocaine Paracervical Block (1%)
Intervention MeSH terms: Lidocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study seeks to compare self-administered lidocaine gel for pain control during cervical
      preparation for dilation and evacuation (D&E) to paracervical block.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women 18 and older

          -  Intrauterine pregnancy ≥16 weeks gestation

          -  English speaking competency

          -  Willing and able to sign consent forms

          -  Agree to comply with study procedures

        Exclusion Criteria:

          -  Women less than 18 years of age

          -  IV conscious sedation

          -  Known allergy to study medication (lidocaine)

          -  Any women not meeting inclusion criteria above will be excluded from participation
A Trial of Degarelix in Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Degarelix; Goserelin acetate
Intervention description: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).; The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
Intervention MeSH terms: Goserelin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 859.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of
      degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in
      patients with prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older.

          -  Has a histological confirmed prostate cancer Gleason graded).

          -  Has a screening testosterone above 2.2 ng/mL.

          -  Rising prostate-specific antigen (PSA).

          -  Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2.

          -  Has a life expectancy of at least one year.

        Exclusion Criteria:

          -  Current or previous hormone therapy.

          -  Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks,
             respectively, prior to screening.

          -  Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria
             and/or angioedema.

          -  Has a heart insufficiency.

          -  Has a previous history or presence of another malignancy, other than prostate cancer
             or treated squamous/basal cell carcinoma of the skin, within the last five years.

          -  Has a clinically significant medical condition (other than prostate cancer) including,
             but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac,
             neurological, or psychiatric disease and alcohol or drug abuse or any other condition
             which may affect the patient's health or the outcome of the trial as judged by the
             Investigator.

          -  Has received an investigational drug within the last 28 days before the Screening
             Visit or longer if considered to possibly influencing the outcome of the current
             trial.

          -  Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.
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.
In-vivo Efficacy Study of Patient Pre-operative Preps
Condition: Bacterial Reduction on Skin Flora Post-product Application
Intervention: ChloraPrep Hi-Lite Orange; Normal saline; 3M CHG/IPA Prep Tint 10.5-mL; 3M CHG/IPA Prep Tint 26-mL
Intervention description: Apply topically.; Apply topically.; Apply topically.; Apply topically
Intervention MeSH terms: Ethanol; Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 426.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: surgical prep; CHG; IPA

Summary:

      The purpose of this study is to determine the antimicrobial efficacy of the 3M CHG/IPA Prep
      on skin flora of the abdominal and inguinal regions of human subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of any race

          -  Subjects in good general health

          -  Minimum skin flora baseline requirements on abdomen and groin

        Exclusion Criteria:

          -  Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin
             disorders (including acne) on the applicable test areas

          -  Topical antimicrobial exposure within 14 days prior to screening and treatment days

          -  Use of systemic or topical antibiotics, steroid medications, or any other products
             known to affect the normal microbial flora of the skin within 14 days prior to
             screening and treatment days
Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice
Condition: Pediculosis
MeSH terms: Lice Infestations
Intervention: Malathion gel 0.5%; Permethrin 1% rinse
Intervention description: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.; Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present.
Intervention MeSH terms: Permethrin; Malathion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 254.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: Head Lice

Summary:

      In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for
      head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an
      established head lice treatment. The new formulation has been evaluated in 2 previous studies
      of patients 2 years of age and older.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed active head lice infestation

        Exclusion Criteria:

          -  Allergy to pediculicides or hair care products

          -  Scalp conditions other than head lice

          -  Previous head lice treatment within the past 4 weeks

          -  Current antibiotic treatment