bioihbjkbjnl/mcl2 huggingface dataset:
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
Phase 3 Study of OTO-201 in Acute Otitis Externa
Condition: Acute Otitis Externa; Swimmer's Ear
MeSH terms: Otitis; Otitis Externa
Intervention: 12 mg ciprofloxacin; Sham Control
Intervention description: Single administration of OTO-201; Simulated, single adminstration
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 262.0
Sex: All
Minimum age: 6 Months
Healthy volunteers: No

Summary:

      This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study
      in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a
      single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external
      auditory canal of the affected ear(s).
    

Eligibility criteria:

        Inclusion Criteria includes, but is not limited to:

          -  Subject is a male or female age 6 months or older

          -  Subject has a clinical diagnosis of unilateral or bilateral acute otitis externa

          -  Subject or subject's caregiver is willing to comply with the protocol and attend all
             study visits

        Exclusion Criteria includes, but is not limited to:

          -  Subject has tympanic membrane perforation

          -  Subject has eczematoid otitis externa

          -  Subject has diabetes mellitus
A Study of Safety and the Local Anesthetic Effect of AG-920 Ophthalmic Solution in a Pediatric Population
Condition: Anesthesia, Local
Intervention: AG-920; Proparacaine Ophthalmic
Intervention description: AG-920 Sterile Topical Ophthalmic Solution; 0.5% Proparacaine Hydrochloride
Intervention MeSH terms: Proxymetacaine; Propoxycaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to receive a single dose of AG-920 or proparacaine into one (study) eye (2 drops 30 seconds apart).
Masking: Single (Participant)
Masking description: The study is single masked. Treatment assignments will be masked to the subjects and their parent/legal guardian only.
Enrollment: 61.0
Sex: All
Maximum age: 10 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: AG-920; Articaine; Septocaine; Intravitreal Injection; Proparacaine

Summary:

      A Phase 3, randomized, active-controlled, study in pediatric subjects. It is designed to
      evaluate the safety and anesthetic efficacy of one dose of AG-920 ophthalmic solution
      compared to Proparacaine Hydrochloride Ophthalmic Solution.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Pre-pubescent with no childbearing potential

          2. Capable of undergoing an eye exam

          3. Subject's legally appointed and authorized representative willing to sign and date an
             informed consent form (ICF) and, where appropriate, the subject willing to sign an
             assent form prior to any study-related procedures being performed.

          4. Parent/legal guardian and subject are willing and able to follow instructions and can
             be present for the required study visits and Follow-up Phone Call for the duration of
             the study.

          5. Have a healthy, normal cornea.

        Exclusion Criteria:

          1. Have participated in an investigational study (drug or device) within the past 30
             days.

          2. Have a known contraindication to local anesthetics.

          3. Children with known autism spectrum disorders or known to have heightened sensitivity.

          4. Corneal pathology that would make the corneal sensitivity lower/higher or make the
             test hard to perform or interpret.

          5. Have low visual acuity

          6. Manifest nystagmus

          7. Have had ocular surgery or general surgery within the past 45 days.

          8. Have had an intravitreal injection in either eye within 14 days of randomization.

          9. Have ocular surface disease.
Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder
Condition: Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Levomilnacipran ER; Placebo
Intervention description: Drug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.; Matching placebo to be given orally, in capsule form, once daily.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 734.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of Levomilnacipran ER
      relative to placebo in the prevention of depression relapse in patients with major depressive
      disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, 18-65 years old

          -  Currently meet the DSM-IV-TR criteria for Major Depressive Disorder

          -  The patient's current depressive episode must be at least 4 weeks in duration

        Exclusion Criteria:

          -  Women who are pregnant, women who will be breastfeeding during the study, and women
             with childbearing potential who are not practicing a reliable method of birth control

          -  Patients with a history of meeting DSM-IV-TR criteria for:

               -  any manic or hypomanic episode

               -  schizophrenia or any other psychotic disorder

               -  obsessive-compulsive disorder

          -  Patients who are considered a suicide risk
Randomized Controlled Trial of Treatment of Male Partners of Women With BV
Condition: Recurrent Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Intervention: Metronidazole (male partner); Placeob (male partner)
Intervention description: 500 mg PO BID for 7 days; matching placebo capsules PO BID for 7 days
Intervention MeSH terms: Metronidazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 214.0
Sex: All
Minimum age: 19 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: bacterial vaginosis; recurrence; male partner

Summary:

      Male partners of womoen with recurrent bacteria vaginosis are randomized to treatment with
      metronidazole or placebo to compare the rates of recurrent BV in the women
    

Eligibility criteria:

        Inclusion Criteria: Female

          1. At least 18 years of age (19 years of age in Alabama due to State law)

          2. Sexual partner to a female who meets study eligibility

          3. Willingness to provide informed consent

          4. Willingness to abstain from sexual intercourse or use condoms {during the study}

          5. Willingness to abstain from alcohol for the first week of the study

        Inclusion Criteria: Male

          1. At least 18 years of age (19 years of age in Alabama due to State law)

          2. Heterosexual with a regular partner

          3. History of 2 or more episodes of BV in the previous 12 months

          4. Symptoms of BV including vaginal discharge and/or odor

          5. Positive Amsel criteria for BV including vaginal pH >4.5, positive whiff test,
             presence of clue cells

          6. Willingness to provide informed consent

          7. Willingness to abstain from sexual intercourse or use condoms {during the study}

          8. Willingness to abstain from alcohol for the first week of the study

        Exclusion criteria (both genders)

          1. Allergy to metronidazole

          2. Failure of the male partner to keep his appointment to be seen within 48 hours

          3. Pregnant or breast feeding (females)

          4. HIV or other chronic disease which in the opinion of the investigator would interfere
             with the ability to participate in this study

          5. Subject requires concurrent lithium, coumadin, dilantin, or antabuse

          6. Presence of trichomonas on wet prep of vaginal fluid (females)

          7. Women with a history of recurrent BV for >3 years or women who have failed previous
             treatment studies for BV
A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Peficitinib
Intervention description: Oral Tablet
Intervention MeSH terms: Peficitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 843.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Smyraf; Rheumatoid Arthritis; Peficitinib; ASP015K

Summary:

      This study evaluated the safety and efficacy of long-term administration of ASP015K in
      patients who have completed Phase IIb or Phase III studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has completed treatment with the study drug in studies RAJ1, RAJ3 or RAJ4 as
             specified in the protocol

          -  The subject himself/herself wishes to continue taking the study drug, and the
             investigator or sub-investigator deems continued administration to be necessary or
             appropriate

        Exclusion Criteria:

          -  There were abnormal findings in the x-ray taken at Week 0, and an acute or chronic
             infection, tuberculosis infection, or malignancy is suspected

          -  Hepatitis B virus or hepatitis C virus carrier or has a history of a positive test for
             human immunodeficiency virus (HIV) infection

          -  Subject has concurrent autoimmune disease (except Sjogren's syndrome) other than RA or
             a history of it

          -  Subject has a clinically significant infection or disease (requiring hospitalization
             or parenteral therapy)

          -  Subject has QTc < 300 msec on ECG measurements performed at the study site at Week 52
             of studies RAJ3 or RAJ4 and has QTc < 300 msec at retest.
Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)
Condition: Non-Small-Cell Lung Carcinoma NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: MEDI4736 (Durvalumab); MEDI4736 (Durvalumab)+Tremelimumab; Paclitaxel + Carboplatin; Gemcitabine + Cisplatin; Gemcitabine + Carboplatin; Pemetrexed + Cisplatin; Pemetrexed + Carboplatin; Tremelimumab
Intervention description: Chemotherapy Agents; Chemotherapy Agents; Chemotherapy Agents; Chemotherapy Agents; Chemotherapy Agents
Intervention MeSH terms: Paclitaxel; Cisplatin; Carboplatin; Gemcitabine; Pemetrexed; Durvalumab; Tremelimumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1118.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: NSCLC, PD-L1, MEDI4736, Tremelimumab, PFS, OS

Summary:

      This is a randomized, open-label, multi-center, global, Phase III study to determine the
      efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy
      versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal
      growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced
      or metastatic NSCLC
    

Eligibility criteria:

        Inclusion Criteria:

        For inclusion in the study, patients should fulfill the following criteria:

          -  Aged at least 18 years

          -  Documented evidence of Stage IV NSCLC

          -  No sensitizing EGFR mutation or ALK rearrangement

          -  No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC

          -  World Health Organization (WHO) Performance Status of 0 or 1

        Exclusion Criteria:

        Patients should not enter the study if any of the following exclusion criteria are
        fulfilled:

          1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant

          2. Brain metastases or spinal cord compression unless asymptomatic, treated and stable
             (not requiring steroids)

          3. Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other
             anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1
             (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies,
             excluding therapeutic anticancer vaccines

          4. Active or prior documented autoimmune or inflammatory disorders (including
             inflammatory bowel disease [eg, colitis or Crohn's disease]
Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: dimethyl fumarate
Intervention description: administered orally
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatrics

Summary:

      The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects
      who completed Study 109MS202 (NCT02410200). Secondary objectives are as follows: To evaluate
      the long-term efficacy of BG00012 and to describe the long-term Multiple Sclerosis (MS)
      outcomes in subjects who completed Study 109MS202 (NCT02410200).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Ability of parents, legal guardians, and/or subjects to understand the purpose and
             risks of the study and provide signed and dated informed consent and authorization to
             use confidential health information in accordance with national and local subject
             privacy regulations. Subjects will provide assent in addition to the parental or
             guardian consent, as appropriate, per local regulations.

          -  Subjects who completed, as per protocol, the previous BG00012 clinical study 109MS202
             (NCT02410200) and remain on BG00012 treatment.

        Key Exclusion Criteria:

          -  Unwillingness or inability to comply with study requirements, including the presence
             of any condition (physical, mental, or social) that is likely to affect the subject's
             ability to comply with the protocol.

          -  Any significant changes in medical history occurring after enrollment in the parent
             Study 109MS202 (NCT02410200), including laboratory test abnormalities or current
             clinically significant conditions that in the opinion of the Investigator would have
             excluded the subject's participation from the parent study. The Investigator must
             re-review the subject's medical fitness for participation and consider any factors
             that would preclude treatment.

          -  Subjects from Study 109MS202 (NCT02410200) who could not tolerate study treatment.

        NOTE: Other protocol defined inclusion/exclusion criteria may apply.
A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: TNX-102 SL; Placebo SL Tablet
Intervention description: Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.; Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
Intervention MeSH terms: Cyclobenzaprine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 503.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pain; Sleep; Fibromyalgia; FM

Summary:

      This is a Phase 3, randomized, parallel-group, double-blind, placebo-controlled, 14-week
      study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets)
      taken daily at bedtime for the treatment of fibromyalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is male or female 18 to 65 years of age, inclusive.

          -  The patient has a diagnosis of primary FM as defined by the 2016 Revisions to the
             2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology
             Preliminary Diagnostic Criteria)

          -  The in-clinic 7-day recall NRS average daily pain intensity score at Screening Visit
             within protocol specified range.

        Exclusion Criteria:

          -  History of or evidence for a diagnosis of borderline personality disorder (BPD).
Self-Administered Lidocaine Gel for Pain Management With IUD Insertion
Condition: IUD Insertion
Intervention: Vaginal 2% Lidocaine; Surgical Lubricant Jelly
Intervention description: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly; Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly
Intervention MeSH terms: Lidocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 220.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pain Management; IUD insertion

Summary:

      For intrauterine device (IUD) insertion, currently there are no standardized clinical
      guidelines for pain management. The investigators aim to explore whether adequate pain relief
      is possible through self-administered, non-invasive means alone. Reducing pain associated
      with IUD insertion may benefit patients and providers. When patients are comfortable during
      their procedure, it is likely the provider can more quickly and with fewer complications
      perform the insertion. The investigators propose to explore the effect of a locally applied
      vaginal lidocaine gel in place of the standard of care pain management, no intervention,
      prior to IUD insertions. This is a superiority, blinded, randomized controlled trial.
    

Eligibility criteria:

        Inclusion Criteria:

        Elective IUD insertion (any type of IUD, copper or hormonal); at an out-patient setting at
        Stanford; English or Spanish speaking, and ability to give informed consent.

        Exclusion Criteria:

        Any pre-operative use of misoprostol; or use of PO pain control medication (i.e. ibuprofen
        or acetaminophen) prior to procedure. Allergy to study medications: lidocaine, or surgical
        lubricant jelly, known uterine anomaly; prior cervical surgery; and no prior use of
        tampons.