bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial to Assess Efficacy, Safety and Tolerability of Botulinum Toxin A (Xeomin®) in Treatment of Expression Wrinkles in the Upper Third of the Face
Condition: Skin Aging
Intervention: Botulinum Toxin A
Intervention description: 100 U DL50 lyophilized powder for reconstitution in 1 ml Saline Solution 0.9%.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: Female
Minimum age: 30 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Botulinum Toxin A; Wrinkles

Summary:

      The purpose of this study is to determinate whether Xeomin® (Botulinum toxin Type A) is safe,
      effective and tolerable in woman aged 30 to 50 years old for treatment of mild, moderate or
      severe expression lines (wrinkles) in the upper third of the face. The main outcome was the
      change in appearance of the wrinkles two weeks (visit 3) after product application as
      compared with baseline assessment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women aged 30 to 50 years old, inclusive.

          -  Mild, moderate or severe expression wrinkles.

          -  Patients who had understood and signed the Informed Consent Form.

        Exclusion Criteria:

          -  Subjects treated with botulinum toxin on the upper third of the face within the
             previous 6-month period;

          -  Former implantation of permanent material and surgery (scars).

          -  Use of any anticoagulant agent up to 7 days prior to the investigational product
             application;

          -  Concomitant use of aminoglycosides or of any other drug that may impair in the
             neuromuscular transmission;

          -  Coagulopathies and local inflammation/ infection at the application site.

          -  Diseases which do impact on the neuromuscular function, such as: myasthenia gravis,
             Eaton Lambert Syndrome;

          -  Pregnancy or breast feeding, women with potential to become pregnant or who do not
             agree to use an effective contraception method (Pearl Index < 1%);

          -  Allergy or known sensitivity to any of the components of the investigational drug;

          -  Subjects who were enrolled in other clinical trial for the last 12-month period prior
             to the present study, as per Resolution 251/97;

          -  Subjects who disagree with the study procedures, who do not sign the Informed Consent
             Form or who are not committed to participate in the trial.
MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL)
Condition: Glabellar Lines; Lateral Canthal Lines
Intervention: MT10109L; Placebo
Intervention description: MT10109Lwill be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.; Placebo will be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 415.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of MT10109L for the treatment of glabellar lines (GL)
      with or without concurrent treatment of lateral canthal lines (LCL) in participants with
      moderate to severe GL and LCL.
    

Eligibility criteria:

        Inclusion Criteria

        • Female participants must not be pregnant or planning to get pregnant and willing to
        minimize the risk of inducing pregnancy for the duration of the clinical study and
        follow-up period.

        Exclusion Criteria

          -  Known immunization or hypersensitivity to any botulinum toxin serotype.

          -  Any medical condition that may put the participant at increased risk with exposure to
             MT10109L including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic
             lateral sclerosis, or any other condition that might interfere with neuromuscular
             function.

          -  History of facial nerve palsy.

          -  Any uncontrolled systemic disease.

          -  Anticipated need for treatment with botulinum toxin of any serotype for any reason
             during the study (other than study intervention).

          -  Anticipated need for surgery or overnight hospitalization during the study.

          -  Prior exposure to botulinum toxin of any serotype for any reason.

          -  Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow
             lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery).

          -  Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg,
             Gore-Tex®), and/or autologous fat transplantation.

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within 30 days of entry into this study.

          -  Females who are pregnant, nursing, or planning a pregnancy during the study.

          -  Participants who plan for an extended absence away from the immediate area of the
             study site that would preclude them from returning for all protocol-specified study
             visits.
A Dose-response Study Examining the Contribution of GLP-1 Receptor Signaling to Glucagon-stimulated Insulin Secretion
Condition: Healthy
Intervention: Exendin-9,39; Saline
Intervention description: Exendin-9,39 is a competitive antagonist of GLP-1 actions at the GLP-1 receptor; Placebo comparator
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The GLP-1 receptor (GLP1R) gene is found on the beta cells of the pancreas. Its role is in
      the control of blood sugar level by enhancing insulin secretion from the pancreas after
      eating a meal. The purpose of this research study is to evaluate the role of GLP1R in the
      response to elevated glucagon concentrations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  20 weight-stable, non-diabetic subjects

        Exclusion Criteria:

          -  Age < 25 or > 65 years (to avoid studying subjects who could have latent type 1
             diabetes, or the effects of age extremes in subjects with normal or impaired fasting
             glucose).

          -  HbA1c ≥5.9%

          -  Use of glucose-lowering agents.

          -  For female subjects: positive pregnancy test at the time of enrollment or study

          -  History of prior upper abdominal surgery such as adjustable gastric banding,
             pyloroplasty and vagotomy.

          -  Active systemic illness or malignancy.

          -  Symptomatic macrovascular or microvascular disease.
A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Insulin Lispro (U100)
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin Lispro; Tirzepatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1428.0
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 purpose of this study is to compare the safety and efficacy of the study drug tirzepatide
      to insulin lispro (U100) three times a day in participants with type 2 diabetes that are
      already on insulin glargine (U100), with or without metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been diagnosed with type 2 diabetes mellitus (T2DM)

          -  Have HbA1c between ≥7.5% and ≤11%

          -  Have been treated for at least 90 days prior to day of screening with once or twice
             daily basal insulin with or without stable dose of metformin ≥1500 mg/day and up to
             maximum approved dose per country specific approved label, sulfonylureas or dipeptidyl
             peptidase 4 inhibitors

          -  Be of stable weight (± 5%) for at least 90 days

          -  Have a BMI ≥23 kilograms per meter squared (kg/m²) and ≤45 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 macular edema or nonproliferative
             diabetic retinopathy requiring immediate or urgent treatment

          -  Have disorders associated with slowed emptying of the stomach, have had any stomach
             surgeries for the purpose of weight loss, or are chronically taking drugs that
             directly affect gastrointestinal motility

          -  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

          -  Have an estimated glomerular filtration rate <30 mL/minute/1.73 m² [for participants
             on metformin, estimated glomerular filtration rate <45 mL/min/1.73 m2 (or lower than
             the country-specific threshold for using the protocol-required dose of metformin per
             local label)]
A Two Comparator, Controlled Phase 3 Study in Patients With and Without Evaporative Dry Eye
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: Omega 3; Optive Advanced; Optive
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Omega 3 (OM3) Tear is a new unit dose emulsion, containing flaxseed/castor oil, which is
      being developed by Allergan. It is desirable to understand the effect that this new emulsion
      has on tear film evaporation and tear lipid profile via interferometry, in patients with
      evaporative dry eye (EDE) and those without (non-EDE). It would also be valuable to evaluate
      the retention time of the lipid components of the new emulsion via tear collection and
      analysis in EDE and non-EDE patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to read and comprehend English and give informed consent as demonstrated by
             signing a record of informed consent;

          -  Over 18 years of age;

          -  Not wearing contact lenses in the past 3 months before enrolling

          -  Willing to use eye drops and comply with the study visit schedule as directed by the
             Investigator;

          -  Habitual (corrected or uncorrected) visual acuity of 6/9.5 or better in each eye;

          -  At the Screening visit (Day -14), patients must have Ocular Surface Disease Index
             (OSDI) score >18 (0 to 100 scale). At Baseline (Day 1) visits, patients must have OSDI
             score > 12 to continue in the study.

          -  TBUT≤10sec in at least 1 eye at Screening visit and Baseline visit

          -  Corneal sodium fluorescein staining score ≥ 1 and <4 (Oxford scheme) at Screening and
             Baseline visit.

        Exclusion Criteria:

          -  Schirmer test (with anesthesia) ≤ 2 mm in either eye at Screening

          -  Patients who are currently using topical ocular medication or have used topical ocular
             medication within 2 weeks of the Screening visit. Patients who are being treated
             bilaterally with a marketed artificial tear for dry eye can be considered, provided
             they discontinue use at the Screening visit;

          -  Any active anterior segment disease excluding blepharitis;

          -  Any systemic disease that may affect ocular health e.g. Graves disease, and
             auto-immune diseases such as ankylosing spondylitis, multiple sclerosis and systemic
             lupus erythematosus;

          -  History of epilepsy or migraines exacerbated by flashing, strobe-like lights;

          -  Rigid or soft contact lens wearer, including orthokeratology;

          -  History of eye surgery within 6 months prior to enrolment in the study;

          -  Previous corneal refractive surgery
20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 20-valent pneumococcal conjugate vaccine; 13-valent pneumococcal conjugate vaccine
Intervention description: Pneumococcal conjugate vaccine; Pneumococcal conjugate vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1511.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female infants born at ≥34 weeks of gestation and who are 2 months of age (≥42
             to ≤98 days) at the time of consent (the day of birth is considered day of life 1).

          -  Healthy infants determined by clinical assessment, including medical history and
             clinical judgment, to be eligible for the study.

        Exclusion Criteria:

          -  Previous vaccination with any licensed or investigational pneumococcal vaccine, or
             planned receipt through study participation.

          -  Major known congenital malformation or serious chronic disorder.
Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
Condition: Diabetic Retinopathy
MeSH terms: Macular Edema; Diabetic Retinopathy
Intervention: ruboxistaurin; placebo
Intervention description: 32 mg once daily (QD) oral for up to 36 months; QD oral for up to 36 months
Intervention MeSH terms: Ruboxistaurin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 731.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an
      eye disease called macular edema in patients with diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 or Type 2 diabetes

          -  18 years or older

          -  Non-clinically significant diabetic macular edema

          -  Mild to moderate diabetic retinopathy in the study eye, vitreous hemorrhage in the
             study eye

          -  Relatively good vision (20/30 or better)

        Exclusion Criteria:

          -  Surgery or laser treatment in the study eye

          -  Glaucoma in the study eye

          -  Glycosylated hemoglobin (HbA1c) greater than 11%, or systolic blood pressure greater
             than 170 millimeters of mercury (mmHg)

          -  Liver disease, dialysis or renal transplant
5% Topical Ibuprofen (IBU) for Ankle Sprain
Condition: Ankle Injuries
MeSH terms: Sprains and Strains; Ankle Injuries
Intervention: Topical IBU twice daily; Placebo twice daily; Topical IBU three times daily; Placebo three times daily
Intervention description: Topical gel administered as 4 inch strip twice daily for 7 days, and as needed for an additional 3 days; Topical gel administered as a 4 inch strip twice daily for 7 days, and as needed for an additional 3 days; Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days; Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 304.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: topical ibuprofen; ankle sprain

Summary:

      This study is being conducted to evaluate the effects of IBU 5% Topical Gel versus topical
      placebo for the relief of pain associated with a first or second degree ankle sprain. Both
      twice daily and three times daily regimens will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  First or second degree ankle sprain within 48 hours of first dose of study medication

          -  Medically cleared to participate

        Exclusion Criteria:

          -  Similar injury of same joint within last 6 months

          -  Requires bed rest, surgery, or over-the-counter or prescription analgesics
Nitrous Oxide for External Cephalic Version
Condition: External Cephalic Version
Intervention: Nitrous Oxide; Placebo
Intervention description: 50% nitrous oxide/50% oxygen via Nitronox delivery device; 100% oxygen via Nitronox delivery device
Intervention MeSH terms: Nitrous Oxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: The Nitronox device will be covered. The person setting up the device with either 100% oxygen or 50% nitrous/50% oxygen, will not be participating in the study. The patient, investigator and labor and delivery personnel (obstetrician and nursing staff) will be blinded as to the medication being administered during the procedure.
Enrollment: 48.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: breech presentation; nitrous oxide; analgesia; pregnancy

Summary:

      This study seeks to determine the effectiveness of nitrous oxide in reducing the anxiety and
      pain associated with external cephalic version (ECV); a maneuver to turn the fetus from
      breech to cephalic position.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female 18 years or greater

          -  Scheduled to undergo external cephalic version due to singleton breech presentation

          -  Not scheduled to have spinal or epidural anesthesia during the version procedure

          -  American Society of Anesthesiology (ASA) Physical Status 1, 2 or 3.

          -  Able to provide informed consent and adhere to study protocol

        Exclusion Criteria:

          -  Current or historical evidence of any clinically significant disease or condition,
             especially cardiovascular or neurological conditions that, in the opinion of the
             Investigator, may increase the risk of exposure to nitrous oxide or complicate the
             subject's post-procedural course.

          -  Significant medical conditions or laboratory results that, in the opinion of the
             Investigator, indicate an increased vulnerability to study drugs and procedures.
Study of SkQ1 as Treatment for Dry-eye Syndrome
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Intervention: Low Dose - SkQ1; High dose - SkQ1; SkQ1 (Vehicle)
Intervention description: SkQ1 Low dose ophthalmic solution; SkQ1 High Dose ophthalmic solution; Vehicle for SkQ1 ophthalmic solution
Intervention MeSH terms: Benzalkonium Compounds
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel-group study of two strengths of ophthalmic solution versus placebo solution
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 452.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dry Eye; Dry Eye Syndrome; SkQ1; KCS; Keratoconjunctivitis

Summary:

      The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and
      effective compared to placebo for the treatment of the signs and symptoms of dry eye
      syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 18 years of age;

          -  Provide written informed consent;

          -  Have a subject reported history of dry eye;

          -  Have a history of use of eye drops for dry eye symptoms ;

          -  Ocular Discomfort;

          -  Schirmer's Test score;

          -  Have corneal fluorescein staining ;

          -  Have lissamine green conjunctival Staining ;

          -  Have a conjunctival redness;

        Exclusion Criteria:

          -  Have participated in the previous SkQ1 ophthalmic solution Phase 2 treatment study;

          -  Have any clinically significant slit lamp findings at Visit 1;

          -  Be diagnosed with an ongoing ocular infection or active ocular inflammation at Visit
             1;

          -  Have had any ocular and/or lid surgeries within 6 months of Visit 1 or any planned
             over the study period;

          -  Have an uncontrolled systemic disease;

          -  Be a woman who is pregnant, nursing or planning a pregnancy;

          -  Be a woman of childbearing potential who is not using an acceptable means of birth
             control;

          -  Have a known allergy and/or sensitivity to the study drug or its components ;

          -  Have a condition or be in a situation which the investigator feels may put the subject
             at significant risk, may confound the study results, or may interfere significantly
             with the subject's participation in the study;

          -  Be currently enrolled in an investigational drug or device study or have used an
             investigational drug or device within 30 days of Visit 1;