bioihbjkbjnl/mcl2 huggingface dataset:
Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion
Condition: Abortion in First Trimester
Intervention: Dextromethorphan Hydrobromide; Avicel PH101 (Microcrystalline Cellulose NF) for Compounding; Oxycodone
Intervention description: Dextromethorphan capsule; Placebo capsule; Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.
Intervention MeSH terms: Oxycodone; Dextromethorphan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 156.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: medication abortion; dextromethorphan; pain control

Summary:

      This study evaluates dextromethorphan as a non-opioid adjunctive medication for pain control
      during medication abortion. This is double-blinded, four-arm randomized controlled trial
      enrolling 156 women over a period of 9-12 months: Receiving narcotics+dextromethorphan,
      narcotics and placebo (microcrystalline cellulose), no narcotics and dextromethorphan and no
      narcotics and placebo (microcrystalline cellulose).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women aged 18 and over

          -  Willing to give voluntary consent

          -  English-speaking

          -  Eligible for medication abortion per Planned Parenthood of Western Pennsylvania
             protocol

          -  Self-reported reliable cellular phone access for the duration of study participation

          -  Able to receive and reply to a "test" text at time of consent

          -  Willing to comply with the study protocol

        Exclusion Criteria:

          -  Use of selective serotonin reuptake inhibitors or monoamine oxidase inhibitors due to
             risk of Serotonin Syndrome

          -  Allergy to any component of the medication abortion regimen or study drug

          -  Has any other condition that, in the opinion of the investigator, would preclude
             informed consent, make study participation unsafe, complicate the interpretation of
             the study outcome data, or otherwise interfere with achieving the study objectives

          -  Anticipated use of dextromethorphan during study period
Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer
Condition: Keratitis; Corneal Ulcer
MeSH terms: Corneal Ulcer; Keratitis; Ulcer
Intervention: T4020; Vehicle
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients diagnosed with one chronic keratitis/corneal ulcer

          -  Patients who signed and dated informed consent

        Exclusion Criteria:

          -  Patient under 18 years

          -  Patient with a perforated corneal ulcer OR any risk of immediate perforation of
             corneal ulcer.
A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Mirikizumab; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Mirikizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 530.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; IL-23

Summary:

      The purpose of this study is to evaluate the efficacy and safety of mirikizumab in
      participants with moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with chronic plaque psoriasis based on an investigator confirmed diagnosis of
             chronic psoriasis vulgaris for at least 6 months prior to baseline and meet the
             following criteria:

               -  plaque psoriasis involving ≥10% BSA and absolute PASI score ≥12 in affected skin
                  at screening and baseline

               -  sPGA score of ≥3 at screening and baseline

          -  Candidate for systemic therapy and/or phototherapy for psoriasis.

        Exclusion Criteria:

          -  Have an unstable or uncontrolled illness, including but not limited to a
             cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine,
             hematologic, or neurologic disease or abnormal laboratory values at screening, that in
             the opinion of the investigator, would potentially affect participant safety within
             the study or of interfering with the interpretation of data.

          -  Breastfeeding or nursing women.

          -  Have had serious, opportunistic, or chronic/recurring infection within 3 months prior
             to screening.

          -  Have received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or
             received live vaccine(s) (including attenuated live vaccines) within 12 weeks of
             baseline or intend to receive either during the study.

          -  Have any other skin conditions (excluding psoriasis) that would affect interpretation
             of the results.

          -  Have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days
             prior to baseline.

          -  Have received topical psoriasis treatment within 14 days prior to baseline.

          -  Have received anti-tumor necrosis factor (TNF) biologics, or anti-interleukin (IL)-17
             targeting biologics within 12 weeks prior to baseline.

          -  Have previous exposure to any biologic therapy targeting IL-23 (including
             ustekinumab), either licensed or investigational.
Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects
Condition: Dyskinesias; Parkinson's Disease; Severe Motor Fluctuations
MeSH terms: Parkinson Disease; Dyskinesias
Intervention: Levodopa-carbidopa intestinal gel; CADD-Legacy® 1400 ambulatory infusion pump; PEG tube; J-tube
Intervention description: Infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour).; percutaneous endoscopic gastrostomy tube; jejunal tube
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: carbidopa; severe motor fluctuations; intestinal gel; levodopa; efficacy; levodopa carbidopa intestinal gel; dyskinesia; Parkinson's Disease; Duodopa; levodopa-carbidopa; DUOPA

Summary:

      Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Idiopathic Parkinson's disease (PD) according to United Kingdon Parkinson's Disease
             Society (UKPDS) Brain Bank Criteria

          -  Levodopa-responsive with severe motor fluctuations

          -  Completion of protocol S187.3.001 (NCT00357994) or S187.3.002 (NCT00660387) and
             continue to meet the inclusion criteria for the preceding study

        Exclusion Criteria:

          -  Patients with medically relevant abnormal findings (labs, electrocardiogram [ECG],
             physical examination, adverse events, psychiatric, neurological or behavioral
             disorders, etc.) at end of the double-blind phase (Week 12) of Study S187.3.001
             (NCT00357994) or Study S187.3.002 (NCT00660387)
Safety and Efficacy of Albiglutide in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: albiglutide; placebo
Intervention description: albiglutide weekly subcutaneous injection; placebo weekly subcutaneous injection
Intervention MeSH terms: rGLP-1 protein
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 310.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes

Summary:

      The purpose of this study is to determine the safety, tolerability and efficacy of
      albiglutide in the treatment of type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 2 diabetes

          -  BMI 20-45kg/m2

        Exclusion Criteria:

          -  NYHA Class II to IV heart failure

          -  females who are pregnant, lactating, or less than 6 weeks post-partum
Efficacy Confirmation Study of CDP870 in Early Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo; CZP; methotrexate (MTX)
Intervention description: Subcutaneous (SC); SC; oral
Intervention MeSH terms: Certolizumab Pegol; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 319.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Cimzia; Early RA; Certolizumab Pegol

Summary:

      The objective of this study is to assess the efficacy of certolizumab pegol (CZP) with
      methotrexate (MTX) compared with MTX-alone in patients with early-stage rheumatoid arthritis
      (RA) who are naive to MTX and have with poor prognostic factors, using inhibition of
      radiographically confirmed joint damage progression over a one-year period as a primary
      endpoint. Following a year of treatment with CZP plus MTX treatment, CZP will be
      discontinued, and the subjects will be monitored for one more year (the follow-up period) to
      investigate the sustainability of efficacy of CZP during the MTX monotherapy for exploratory
      purposes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with RA as defined by the ACR/EULAR criteria (2010) who meet all of the
             following criteria:

               1. Subjects who developed RA within one year after onset of RA.

               2. Subjects who have never received MTX before (MTX naive)

               3. Subjects whose disease activity is moderate or higher (DAS28(ESR) ≥ 3.2）

               4. Subjects must satisfy at least two of the three criteria (Anti-CCP antibody
                  positive, Rheumatoid factor positive, Presence of X-ray erosion） for poor
                  prognostic factors. The anti-CCP antibody positive is essential for every
                  patient.

        Exclusion Criteria:

          -  Patients who have a diagnosis of any other type of inflammatory arthritis.

          -  Patients who have a secondary, non-inflammatory type of arthritis.

          -  Patients who have used with MTX, reflunomide, or any other biologics prior to the
             start of study drug administration.

          -  Patients who have NYHA (New York Heart Association) Class III or IV congestive heart
             failure

          -  Patients who currently have, or who have a history of, tuberculosis.

          -  Patients who have a high risk of infection (with a current infectious disease, a
             chronic infectious disease, a history of serious infectious disease)

          -  Patients who currently have, or have a history of, malignant tumor

          -  Female patients who are breastfeeding or pregnant, who are of childbearing potential
A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers
Condition: Stomach Ulcer; Duodenal Ulcer
MeSH terms: Duodenal Ulcer; Stomach Ulcer; Ulcer
Intervention: Lansoprazole; Gefarnate
Intervention description: Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 12 to 30 months.; Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 12 to 30 months.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole; Gefarnate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 461.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Curling Ulcer; Gastric Ulcer; Aspirin; Acetylsalicylic Acid; Drug Therapy

Summary:

      The purpose of this study is to determine whether lansoprazole, once daily (QD), compared to
      gefarnate, twice daily (BID), is effective in preventing the recurrence of gastric and
      duodenal ulcers in patients receiving long term treatment with low dosage aspirin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient was on low-dose aspirin treatment on the day when consent was obtained,
             and requires the long-term continuous treatment even after treatment with the
             investigational drug is started.

          -  The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.

        Exclusion Criteria:

          -  Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.

          -  Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.

          -  Current or past history of aspirin-induced asthma or hypersensitivity to nonsteroidal
             anti-inflammatory drugs.

          -  Past or planned surgery affecting gastric acid secretion.

          -  Clinically significant hepatic or renal disorder.
TMC278-TiDP6-C209: A Clinical Trial in Treatment Naive HIV-1 Patients Comparing TMC278 to Efavirenz in Combination With Tenofovir + Emtricitabine.
Condition: HIV Infections; HIV-1; Human Immunodeficiency Virus Type 1
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: TMC278; Efavirenz
Intervention description: 25 mg tablet once daily for 96 weeks; 600mg once daily for 96 weeks
Intervention MeSH terms: Efavirenz; Rilpivirine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 694.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: TMC278-C209; Antiretroviral; Non-nucleoside reverse transcriptase inhibitor; HIV-1; AIDS; TMC278-TiDP6-C209; Treatment Naive

Summary:

      The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278
      given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily,
      when combined with a fixed background regimen consisting of emtricitabine (FTC) + tenofovir
      disoproxil fumarate (TDF), in HIV-1 infected patients who have not yet taken any anti-HIV
      drugs. The following evaluations will be done: antiviral activity, immunologic changes, and
      viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and
      PK/Pharmacodynamics, medical resource utilization and treatment adherence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with documented HIV-1 infection

          -  Patient has never been treated with a therapeutic HIV vaccine or an ARV drug prior to
             screening

          -  Patient's HIV-1 plasma viral load at screening is > 5,000 HIV-1 RNA copies/mL (assayed
             by RNA PCR standard specimen procedure)

          -  Patient's virus is sensitive to TDF and FTC

          -  Patient agrees not to start ART (antiretroviral treatment) before the baseline visit

        Exclusion Criteria:

          -  Previous use of ANY ARV drug for ANY length of time

          -  Any documented evidence of NNRTI resistance associated mutations in patient's HIV

          -  Category C AIDS defining illness, except: stable Kaposi Sarcoma, wasting syndrome if
             not progressive

          -  Pneumocystis carinii pneumonia (PCP) that is considered not cured

          -  Active TB

          -  Allergy or hypersensitivity to study or background ARTs

          -  Specific grade 3 or 4 toxicity

          -  Kidney impairment: calculated creatinine clearance <50 ml/min
Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: IC51; HAVRIX; Placebo
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective is to investigate the immunogenicity of the Japanese Encephalitis vaccine IC51
      (JE-PIV) single and concomitant with HAVRIX® 1440
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  In female subjects either childbearing potential terminated by surgery or one year
             post-menopausal, or a negative serum pregnancy test during screening and the
             willingness not to become pregnant during the study period and 30 days after the last
             vaccination by practicing reliable methods of contraception

          -  Written informed consent obtained prior to study entry

        Exclusion Criteria:

          -  History of clinical manifestation of any flavivirus infection

          -  History of vaccination against Japanese encephalitis (JE), Yellow fever and Dengue
             fever (an anti-JEV neutralizing antibody titer >= 1:10 at baseline is acceptable for
             inclusion, these subjects will be part of the safety population, but will not be
             analyzed for immunogenicity in the per-protocol analysis)

          -  History of any previous Hepatitis A vaccination and infection

          -  Use of any other investigational or non-registered drug or vaccine in addition to the
             study vaccine during the study period or within 30 days preceding the first dose of
             study vaccine

          -  Planned administration of another vaccine during the study period

          -  Immunodeficiency including post-organ-transplantation or immunosuppressive therapy

          -  A family history of congenital or hereditary immunodeficiency

          -  History of autoimmune disease

          -  Administration of chronic (defined as more than 14 days) immunosuppressants or other
             immune-modifying drugs within six months of vaccination.

          -  Any acute infections within 4 weeks prior to enrollment

          -  Infection with human immunodeficiency virus (HIV), Hepatitis B (HBsAg) or Hepatitis C
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Intervention: Synflorix; Prevenar; Infanrix hexa
Intervention description: 1 dose injected IM in the right thigh or deltoid.; 1 dose injected IM in the right thigh or deltoid.; 1 dose injected IM in the right thigh or deltoid.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 1200.0
Sex: All
Minimum age: 12 Months
Maximum age: 18 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Streptococcus pneumonia, pneumococcal conjugate vaccine

Summary:

      This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of
      GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of
      age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553.
      Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization
      course in study 105553 (NCT00307554). The immune response to a booster dose of GSK
      Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to
      subjects not primed with GSK Biologicals' vaccine but with Prevenar™.

      The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal
      conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children
      primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of
      children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal
      conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib
      vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  a healthy male or female, 12 to 18 months of age at the time of vaccination, who
             received at least one dose of either pneumococcal conjugate vaccine or Prevenar™
             during study 105553 and with written informed consent obtained from the
             parent/guardian of the subject.

        Exclusion Criteria:

          -  use of any investigational or non-registered drug or vaccine other than the study
             vaccine within 30 days preceding the vaccination, or planned use during the entire
             study period (active phase and safety follow-up).

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             during the period starting one month before vaccination up to Visit 2.

          -  Administration of any additional pneumococcal vaccine or DTPa-combined vaccine since
             end of study 105553. Children with a history of seizures or neurological disease,
             allergic disease, immunosuppressive or immunodeficient condition.