bioihbjkbjnl/mcl2 huggingface dataset:
MultiPoint Pacing IDE Study
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: MultiPoint Pacing; Traditional Biventricular Pacing
Intervention description: Subjects are programmed to MPP between 3 and 9 months. MPP programming is stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.; Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 506.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This IDE study is a prospective, randomized, double-blind, multi-center clinical study to
      evaluate the safety and efficacy of patient treatment with MPP compared to patient treatment
      with standard BiV pacing at 9 months.

      The study will be conducted at a maximum of 50 investigational centers located in the United
      States. A maximum of 506 subjects implanted with the Quadripolar cardiac resynchronization
      therapy device (CRT-D) system will be enrolled in the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets current clinical indication for implantation of a cardiac resynchronization
             therapy system for treatment of heart failure or life-threatening ventricular
             tachyarrhythmia(s)

          -  Receiving a new CRT implant or undergoing an upgrade from an existing ICD or pacemaker
             implant with no prior LV lead placement

          -  Have the ability to provide informed consent for study participation and are willing
             and able to comply with the prescribed follow-up tests and schedule of evaluations

        Exclusion Criteria:

          -  Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA)
             within 3 months of enrollment

          -  Have an existing Class I recalled lead

          -  Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate

          -  Have a classification of Status 1 for cardiac transplantation or consideration for
             transplantation over the next 9 months

          -  Have permanent atrial fibrillation (AF)

          -  Have undergone a cardiac transplantation within 40 days of enrollment

          -  Have had a recent myocardial infarction, unstable angina within 40 days or cardiac
             revascularization within 3 months of implant.

          -  Are currently participating in a clinical investigation that includes an active
             treatment arm

          -  Are pregnant or planning to become pregnant during the duration of the study

          -  Have a life expectancy of less than 9 months due to any condition

          -  Are less than 18 years of age
Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: placebo oral capsules; ziprasidone oral capsules
Intervention description: Placebo matching the oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dosing design. Dosing is stratified based on weight, with subjects <45 kg having a target dose range of 60-80 mg/day and subjects >/= 45 kg having a target dose range of 120-180 mg/day.; Oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dosing design. Dosing is stratified based on weight, with subjects <45 kg having a target dose range of 60-80 mg/day and subjects >/= 45 kg having a target dose range of 120-180 mg/day.
Intervention MeSH terms: Ziprasidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 171.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Bipolar I Disorder (current or most recent episode manic). Children and adolescents aged 10 to 17 years.

Summary:

      The purpose of this study is to determine if ziprasidone is safe and effective for the
      treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM V criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years.

        Exclusion Criteria:

          -  Imminent risk of suicide or homicide, as judged by the site investigator; any history
             of serious or unstable medical illness, including risk for QT prolongation.
A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Tabalumab Auto-Injector; Tabalumab Prefilled Syringe
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the amount of tabalumab in the blood after it is
      given by two different injection methods - A traditional syringe or a spring loaded syringe
      for 12 weeks. Participants may continue to receive study drug for up to 52 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Lupus.

          -  Able and willing to have blood drawn for PK sampling.

        Exclusion Criteria:

          -  Have severe active lupus nephritis.

          -  Have severe active central nervous system (CNS) or peripheral neurologic disease or
             other severe neurologic involvement requiring treatment within approximately 3 months
             prior to screening.

          -  Have received high dose corticosteroid within approximately 1 month prior to baseline.

          -  Have initiated or adjusted treatment with immunosuppressant drugs within approximately
             1 month prior to baseline.

          -  Have received plasmapheresis within approximately 3 months prior to baseline.

          -  Have previously received approved or experimental B cell targeted therapies within the
             last year.

          -  Have received any biologic or non-biologic therapy within approximately 3 months or 5
             half-lives (whichever is longer).

          -  Have a history of severe reaction to any biologic therapy.

          -  Have an active or recent infection within approximately 1 month prior to Week 0.

          -  Have had a serious infection within approximately 3 month or serious bone/joint
             infection within approximately 6 months prior to baseline.

          -  Have evidence of or test positive for active hepatitis B or are positive for hepatitis
             C or human immunodeficiency virus (HIV).

          -  Have evidence of active or latent tuberculosis.

          -  Have significant hematological abnormalities.
In-vivo Efficacy Study of Patient Preoperative Preps
Condition: Skin Flora Bacterial Reduction Post-product Application
Intervention: 3M CHG/IPA Prep Colorless; 3M CHG/IPA Prep Tint; ChloraPrep; Saline
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: 171.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: surgical skin prep; CHG; IPA

Summary:

      The purpose of this study is to evaluate 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
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Add-on)
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: lurasidone + (lithium or divalproex); Placebo + (lithium or divalproex)
Intervention description: lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.; 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
Intervention MeSH terms: Valproic Acid; Lithium Carbonate; Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 348.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Bipolar I; Latuda; Lurasidone

Summary:

      This clinical study is designed to test the hypothesis that lurasidone is effective,
      tolerable, and safe when added to treatment with lithium or Divalproex for the treatment of
      patients with bipolar I depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is diagnosed with bipolar I disorder, most resent episode depressed

          -  Subject must have a lifetime history of at least one bipolar manic or mixed episode

          -  Subject must be taking lithium or divalproex at least 28 days prior to screening

        Exclusion Criteria:

          -  History of nonresponse to an adequate (6-week) trial of three or more antidepressants
             (with or without mood stabilizers) during the current episode

          -  Subject has been hospitalized for a manic or mixed episode within 60 days prior to
             randomization

          -  Imminent risk of suicide or injury to self, others, or property
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: 176.0
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.
Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis
Condition: Gingivitis
MeSH terms: Gingivitis
Intervention: Triclosan, fluoride; Fluoride
Intervention description: Six Month study, brush twice daily; twice daily usage
Intervention MeSH terms: Triclosan; Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Gingivitis and Plaque

Summary:

      The objective of this study is to evaluate the performance of two toothpastes in controlling
      established gingivitis and dental plaque in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Availability for the six-month duration of the study.

          -  Good general health.

          -  Minimum of 20 uncrowned permanent natural teeth (excluding third molars).

          -  Initial gingivitis index of at least 1.0 as determined by the use of the Loe and
             Silness Gingival Index.

          -  Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein
             Plaque Index (Turesky Modification).

          -  Signed Informed Consent Form.

        Exclusion Criteria:

          -  Presence of orthodontic bands.

          -  Presence of partial removable dentures.

          -  Tumor(s) of the soft or hard tissues of the oral cavity.

          -  Advanced periodontal disease (purulent exudate,tooth mobility, and/or extensive loss
             of

          -  periodontal attachment or alveolar bone).

          -  Five or more carious lesions requiring immediate restorative treatment.

          -  Use of antibiotics any time during the one month prior to entry into the study.

          -  Participation in any other clinical study or test panel within the one month prior to
             entry

          -  into the study.

          -  Pregnant women or women who are breast feeding.

          -  Receive a dental prophylaxis in the past two weeks prior to baseline examinations.

          -  History of allergic to personal care/consumer products or their ingredients.

          -  Taking any prescription medicines. That might interfere with the study outcome.

          -  Individuals with an existing medical condition which prohibits them from not eating or
             drinking for periods up to 4 hours.
Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Bepreve; Placebo
Intervention description: One drop, both eyes, twice a day; One drop, both eyes, twice a day
Intervention MeSH terms: Bepotastine besilate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 861.0
Sex: All
Minimum age: 3 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Safety study for bepotastine besilate ophthalmic solution in normal volunteers
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be at least 3 years of age, and have ocular health within normal limits

        Exclusion Criteria:

          -  No active ocular disease
Study to Evaluate Safety and Efficacy of WC3011 (Estradiol Vaginal Cream) in Postmenopausal Women With Dyspareunia
Condition: Vulvovaginal Atrophy
MeSH terms: Dyspareunia; Atrophy
Intervention: WC3011 Estradiol Vaginal Cream; Vehicle
Intervention description: Daily for 14 days followed by 3 times per week for 10 weeks; Daily for 14 days followed by 3 times per week for 10 weeks
Intervention MeSH terms: Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 550.0
Sex: Female
Minimum age: 35 Years
Healthy volunteers: No
Keywords: Vulvovaginal Atrophy; Dyspareunia; Postmenopausal

Summary:

      The purpose of the study is to determine if WC3011 is safe and effective in treating the
      symptom of painful intercourse secondary to vulvovaginal atrophy as measured by participant
      self-assessment when compared to vehicle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sexually active with self-identified dyspareunia (pain with sexual activity), at least
             moderate to severe and most bothersome symptom of vulvovaginal atrophy (VVA)

          -  Postmenopausal and meets 1 of the following: 12 months spontaneous amenorrhea, 6
             months spontaneous amenorrhea with FSH (follicle stimulating hormone) >40 mIU/mL,6
             weeks postsurgical bilateral oophorectomy with confirmation by FSH >40 mIU/mL,
             surgical report or ultrasound, 6 weeks postsurgical hysterectomy with ovary failure
             confirmed by FSH >40 mIU/mL

          -  Age ≥40 years; ≥35 with bilateral oophorectomy

          -  Vaginal pH >5.0

          -  Less than or equal to 5% superficial cells on vaginal wall cytologic smear

          -  Normal clinical breast exam or negative mammogram if ≥ 40 years of age

          -  Negative urine pregnancy test (non-hysterectomized and <12 months amenorrhea)

        Exclusion Criteria:

          -  Enrollment in Sponsor's Study PR-04409 or PR-05812

          -  Participation in clinical trial or use of investigational drug within 30 days prior to
             screening

          -  Known hypersensitivity to estrogen and/or progestin therapy

          -  Known or suspected premalignant or malignant disease or history steroid-dependent
             malignancy

          -  Manifestation or treatment for significant cardiovascular disease (congestive heart
             failure, stroke or ischemic attack, myocardial infarction, coronary artery bypass,
             percutaneous angioplasty or >50% angiographic narrowing of coronary artery

          -  Thrombophlebitis or thromboembolic disorder or history of

          -  Insulin-dependent diabetes mellitus

          -  Increased frequency or severity of headaches while on hormone or estrogen therapy

          -  Currently taking St. John's Wort

          -  Drug/alcohol addiction within past 2 years

          -  Treatment with anticoagulants (heparin or warfarin)

          -  Smoking ≥15 cigarettes/day
Transversus Abdominis Plane Block in Microsurgical Breast Recon w/Abdominal Free Flap in Breast CA
Condition: Breast - Female
Intervention: Transversus Abdominis Plane (TAP) block; Nimbus Infusion Pump IV Administration; Bupivacaine infusion; Acetominophen; Hydromorphone; Oxycodone; Ondansetron
Intervention MeSH terms: Acetaminophen; Oxycodone; Hydromorphone; Ondansetron; Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective is to determine if pre-operative transversus abdominis plane (TAP)
      nerve blocks by continued infusion of local anesthetic post-operatively affects
      post-operative narcotic usage, as compared to a placebo TAP block, after breast
      reconstruction surgery.
    

Eligibility criteria:

        Inclusion Criteria

          -  Prior diagnosis or presumed diagnosis of breast cancer or undergoing prophylactic
             treatment.

          -  Greater than 18 years old.

          -  Female.

          -  Undergoing microsurgical breast reconstruction with abdominal free flap.

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria

          -  True allergy to local anesthetics or opioids.

          -  History of addiction to narcotics within the last 24 months

          -  History of chronic pain on opioids within the last 24 months.

          -  Specific mental health issues such as schizophrenia or bipolar disorder.

          -  Patients who are pregnant.