bioihbjkbjnl/mcl2 huggingface dataset:
An Open-Label Study Of Pregabalin In Subjects With Refractory Partial Seizures
Condition: Epilepsy
MeSH terms: Seizures
Intervention: pregabalin (LYRICA)
Intervention description: 150 mg up to a maximum of 600 mg per day bid or tid as required
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this trial is to allow continued access to pregabalin to Canadian
      subjects who participated in global pregabalin epilepsy studies 1008-010; 1008-035; 1008-114
      and 1008-164 and to continue to study the long term safety of pregabalin administered as
      adjunctive therapy at dosages from 150 mg/day to 600 mg/day in Canadian subjects with
      refractory partial seizures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have completed Pfizer open-label studies 1008-010; 1008-035; 1008-114 or 1008-164
             and wishes to continue receiving open-label pregabalin

          -  Must have responded favorably to pregabalin in Pfizer open-label study 1008-010,
             1008-035, 1008-114 or 1008-164 and in the clinical opinion of the investigator
             continued treatment with pregabalin is in the the patient's best medical interest

        Exclusion Criteria:

          -  Is pregnant or is considering becoming pregnant during the course of the study

          -  Experienced a serious adverse event during open-label Pfizer study 1008-010, 1008-035,
             1008-114 or 1008-164
Fluoride Varnish Randomized Clinical Trial
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: Fluoride Varnish
Intervention description: 0.1 mL (1 drop) applied on each of 2 arches
Intervention MeSH terms: Fluorides; Fluorides, Topical
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 376.0
Sex: All
Minimum age: 6 Months
Maximum age: 36 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Early Childhood Caries

Summary:

      The purpose of this study is to compare the efficacy of fluoride varnish (FV) applied once or
      twice a year with counseling to counseling alone in preventing early childhood caries (ECC)
      (tooth decay in children under the age of five).
    

Eligibility criteria:

        Inclusion

          -  Children < 44 months old

          -  Caries-free

          -  4 erupted maxillary incisors

          -  Residing in fluoridated community (San Francisco)

        Exclusion

          -  Cleft Palate

          -  Developmental or learning disabilities

          -  Children with transient residence (homeless, migrant, foster home)

          -  Children with an another household member participating in the study
16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Secukinumab; Placebo secukinumab
Intervention description: AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17).; Placebo to AIN457 (Secukinumab)
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 226.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AIN457, ankylosing spondylitis, chronic inflammatory disease, inflammatory back pain, secukinumab, self-injection

Summary:

      The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year
      efficacy, safety and tolerability data in subjects with active AS despite current or previous
      NSAID, DMARD and/or anti-TNF therapy.
    

Eligibility criteria:

        Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the
        Modified NY Criteria (1984), inadequate response to NSAIDs. -- Exclusion criteria:
        pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI,
        previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any
        biological immunomodulating agent excluding TNF antagonists, previous cell depleting
        therapy.
A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
Condition: Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Intervention: Gatifloxacin 0.5% eye drops; placebo eye drops
Intervention description: Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily; Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily
Intervention MeSH terms: Gatifloxacin; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 578.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      The study will determine the safety and efficacy of gatifloxacin eye drops in patients with
      bacterial conjunctivitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically diagnosed with bacterial conjunctivitis

        Exclusion Criteria:

          -  Signs and/or symptoms of conjunctivitis for more than 96 hours

          -  Signs and/or symptoms suggestive of fungal, viral, or allergic conjunctivitis

          -  Clinical diagnosis of chlamydia in either eye
A Phase III Study of Abatacept (BMS-188667) in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Abatacept; Methotrexate; Placebo
Intervention description: Intravenous (IV) Solution, - Weight Titered (500 mg < 60 kg); (750 mg 60-100 kg), )1 gram > 100 kg), Day 1, Day 15, Day 29; every 28 days thereafter, 1 year; Tablets, Oral, >= 15 mg, weekly, 1 year; IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 1 year
Intervention MeSH terms: Methotrexate; Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1250.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Short Term: The purpose of this clinical research study is to learn if abatacept (BMS-188667)
      in combination with methotrexate is better than methotrexate alone in participants that have
      active rheumatoid arthritis and are not responding to methotrexate. The safety of this
      treatment will also be studied.

      Long Term Extension: The purpose of this amendment is to provide participants who have
      completed the initial 12-month double-blind treatment period the opportunity to receive open
      label treatment with active drug treatment until abatacept is approved in the local country
      or until clinical development has been discontinued.
    

Eligibility criteria:

        -  Rheumatoid Arthritis (RA) for greater than 1 year from the time of initial diagnosis
             of RA.

          -  Participants must have been taking methotrexate for at least 3 months with at least a
             weekly dose of 15 mg.
Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester Dilation and Evacuation Abortion
Condition: Abortion; Blood Loss
MeSH terms: Hemorrhage
Intervention: Misoprostol; Folic acid
Intervention description: 400 mcg buccally 2 hours prior to procedure; 2mg buccally 2 hours prior to procedure
Intervention MeSH terms: Folic Acid; Misoprostol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      Misoprostol is a medication used extensively in obstetrics and gynecology for its ability to
      aid in softening the cervix as well as decreasing blood loss after abortion or vaginal
      delivery. Opinions vary as to its usefulness in aiding in cervical dilation, and in
      decreasing blood loss. The investigators propose to conduct a randomized, placebo-controlled
      trial to evaluate whether misoprostol given buccally 2 hours prior to second trimester
      surgical abortion decreases blood loss from the procedure. The investigators will also assess
      whether misoprostol improves cervical dilation, changes the length of the procedure, changes
      the need for additional mechanical dilation, changes the subjective ease of the procedure,
      and changes a woman's pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English or Spanish speaking

          -  Gestational age between 16 weeks 6 days and 20 weeks 6 days gestation by ultrasound
             dating on the day of enrollment

          -  Ultrasound used for dating purposes must be within the last two weeks.

          -  Women 18-50 years of age undergoing surgical termination of pregnancy

        Exclusion Criteria:

          -  Spontaneous fetal demise

          -  Ruptured membranes or intrauterine infection

          -  Fibroids that significantly distort the uterine shape

          -  Uterine abnormality such as unicornuate uterus

          -  Prior transmural myomectomy

          -  Severe oligohydramnios

          -  Morbid obesity with BMI>45

          -  Inability to place osmotic dilators
A Study Evaluating The Efficacy And Safety Of CP-690,550 In Asian Subjects With Moderate To Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: placebo; CP-690,550; CP-690,550
Intervention description: placebo BID for 16 weeks and then re-randomized into active groups; CP-690,550 5mg BID for 52 weeks; CP-690,550 10mg BID for 52 weeks
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 266.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tofacitinib; CP-690; 550; Xeljanz; Jak-Inhibitor; Oral Treatment; Psoriasis vulgaris; Pruritus; Itch; DLQI; moderate; severe; chronic; plaque psoriasis

Summary:

      The primary objective of this study is to compare the efficacy of CP-690,550 (5 mg BID and 10
      mg BID) versus placebo for the reduction in severity of plaque psoriasis after 16 weeks of
      treatment in Asian subjects with moderate to severe chronic plaque psoriasis who are
      candidates for systemic therapy or phototherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had a diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at least 12
             months prior to the first screening procedure.

          -  Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe")
             at Baseline (Day 1).

          -  Considered by dermatologist investigator to be a candidate for systemic therapy or
             phototherapy of psoriasis (either naïve or history of previous treatment).

        Exclusion Criteria:

          -  Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular
             psoriasis, with the exception of nail psoriasis which is allowed.

          -  Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation
             of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or
             lithium.

          -  Subjects who cannot discontinue systemic therapies and/or topical therapies for the
             treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA) for the study
             are excluded.
A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Ustekinumab - Half-Standard Dosage; Ustekinumab - Standard Dosage; Placebo
Intervention description: Ustekinumab 0.375 mg/kg, 22.5 mg, or 45 mg based on body weight, administered subcutaneously (under the skin) at Weeks 0, 4, 16, 28, and 40.; Ustekinumab 0.75 mg/kg, 45 mg, or 90 mg based on body weight administered subcutaneously at Weeks 0, 4, 16, 28, and 40.; Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.
Intervention MeSH terms: Ustekinumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Ustekinumab; Injection; CNTO 1275; Stelara; Pediatric psoriasis; Adolescents

Summary:

      This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients
      with moderate to severe psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (PsA)
             for at least 6 months

          -  Are candidates for phototherapy or systemic treatment of psoriasis

          -  Have screening laboratory test results within the study parameters

        Exclusion Criteria:

          -  Currently have nonplaque forms of psoriasis

          -  Have used any therapeutic agent targeted at reducing interleukin-12 (IL-12) or
             interleukin-23 (IL-23), including but not limited to ustekinumab and briakinumab

          -  Received conventional systemic therapies or phototherapy within the last 4 weeks

          -  Received biologic therapies within the last 3 months
Combined Behavioral and Analgesic Trial for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Tramadol; Placebo; Cognitive Behavior Therapy for FM; Health Education
Intervention description: 50 mg tablets titrated up to 2 tablets four times per day for a maximum dose of 400mg per day.
Minimum accepted dose of 200mg per day; Pharmacological inactive tablet, 50mg tablets titrated to 2 tabs per day up to 400mg; Subjects will be seen for 8 weekly 50 minute sessions of Cognitive Behavior Therapy that has been specifically tailored for Fibromyalgia patients.; Subjects will receive 8 weekly 50 minute sessions of Health Education on Fibromyalgia
Intervention MeSH terms: Tramadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 134.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a randomized control study that involves a combination of a drug treatment,
      behavioral health, and placebo controls.

      Some participants will receive a medication approved by the Food and Drug Administration for
      treatment of moderate to moderately severe pain called Tramadol HC1 IR. Others will receive
      an inactive pill, called a placebo. There will also be 2 different types of behavioral health
      treatments, Cognitive-Behavior Therapy (CBT) and Health Education (HE) both of which have
      been recommended for the treatment of patients with FM by the American Pain Society.

      There are 4 possible study treatment combinations:

        1. Tramadol + CBT,

        2. Tramadol + HE,

        3. Placebo + CBT,

        4. Placebo + HE.

      Although Tramadol, CBT, and HE have been shown to have some benefits for FM patients, there
      have been no studies that have evaluated the combination of medication and a behavioral
      health treatment. The primary purpose of this study is to compare the benefits of the 4
      combinations listed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and Females 21-70

          -  Diagnosis of Fibromyalgia

          -  Current primary care physician

          -  Fluent in English

        Exclusion Criteria:

          -  Rheumatologic disorders

          -  Drug and alcohol abuse in the past year

          -  Psychiatric hospitalization in the past 6 months

          -  Current use of Tramadol

          -  Certain antidepressant and other pain medications
Oral Omadacycline vs. Oral Linezolid for the Treatment of ABSSSI
Condition: Bacterial Infections; Skin Structures and Soft Tissue Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Soft Tissue Infections
Intervention: Omadacycline; Linezolid
Intervention description: po tablets; po tablets
Intervention MeSH terms: Linezolid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 735.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of omadacycline as compared
      to linezolid in the treatment of adults with acute bacterial skin and skin structure
      infections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients, ages 18 years or older who have signed the informed consent

          -  Has a qualifying skin and skin structure infection

          -  Female patients must not be pregnant at the time of enrollment

          -  Must agree to a reliable method of birth control during the study and for 30 days
             following the last dose of study drug

        Exclusion Criteria:

          -  Infections where the outcome is strongly influenced by factors other than
             protocol-defined treatments and procedures, or that require antibacterial treatment
             for greater than 14 days

          -  Evidence of significant immunological disease

          -  Severe renal disease or requirement for dialysis

          -  Evidence of septic shock

          -  Has a history of hypersensitivity or allergic reaction to any tetracycline or to
             linezolid

          -  Has received an investigational drug within the past 30 days

          -  Women who are pregnant or nursing
Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Nivolumab; Cetuximab; Cisplatin; Radiotherapy
Intervention description: Specified dose on specified day; Specified dose on specified day; Specified dose on specified day; Specified dose on specified day
Intervention MeSH terms: Nivolumab; Cetuximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study has two, independent, cohorts, both in locally advanced squamous cell head and
      neck cancer. The purpose of the first cohort is to determine whether nivolumab in combination
      with radiotherapy is more effective than cetuximab in combination with radiotherapy, in
      subjects who are ineligible for cisplatin. The purpose of the second cohort is to determine
      whether nivolumab, cisplatin, and radiotherapy is more effective than cisplatin and
      radiotherapy in subjects who are eligible to receive cisplatin
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Histologically proven squamous cell carcinoma of the head and neck (SCCHN) from one of
             the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx

          -  Locally advanced disease which is unresectable, or resectable but suitable for an
             organ sparing approach

          -  No previous radiotherapy or systemic treatment for SCCHN

        Exclusion Criteria:

          -  Carcinoma originating in the nasopharynx or paranasal sinus, squamous cell carcinoma
             that originated from the skin and salivary gland or non-squamous histology (e.g.,
             mucosal melanoma), squamous cell carcinoma of unknown primary

          -  Clinical or radiological evidence of metastatic disease

          -  Prior radiotherapy that overlaps with radiation fields

        Other protocol defined inclusion/exclusion criteria could apply
Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures
Condition: Fractures, Open
MeSH terms: Fractures, Bone; Fractures, Open
Intervention: Tobramycin; Placebo: normal saline
Intervention MeSH terms: Tobramycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to investigate the effectiveness of local antibiotic
      versus placebo in the prevention of infections in open fractures. The study will assess
      whether local treatment of open fractures with the antibiotic tobramycin (in addition to
      standard systemic antibiotics) will decrease the risk and rate of infection, and rate of
      re-operation. This will be studied using a randomized controlled clinical trial design in
      adult population of age 18-70 years who present with open fractures. About 133 subjects will
      be recruited in this study at UVA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18 - 70 years

          -  Gustilo Type I,II,IIIa open fracture (s)

          -  Ability to provide informed consent (or proxy consent in cases where subject is
             temporarily impaired when intubated and sedated)

          -  Subject should be able to follow up at the scheduled times following surgery

          -  Subjects who may have compartment syndrome, renal insufficiency, and those who are
             immunosuppressed regardless of antibiotic administration will also be included in the
             study

        Exclusion Criteria:

          -  Closed fracture

          -  Severe injury requiring flap coverage or vascular reconstruction (Gustilo-Anderson
             Type IIIB and C respectively)

          -  Aminoglycoside allergy

          -  Presentation greater than 48 hours after injury

          -  Pathologic fracture

          -  Preexisting infection in bone with an open fracture

          -  Patients with multiple trauma involving liver, kidney, or brain

          -  Pregnancy (self-reported)

          -  Current status as prisoner