bioihbjkbjnl/mcl2 huggingface dataset:
Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Etanercept; Methotrexate; Placebo to Etanercept; Placebo to Methotrexate
Intervention description: Etanercept was administered by subcutaneous injection once a week; Methotrexate capsules taken orally once a week. Dosing was initiated at 10 mg weekly and titrated up to a final dose of 20 mg weekly over a 4-week period.; Placebo to etanercept was administered by subcutaneous injection once a week.; Placebo to methotrexate capsules taken orally once a week.
Intervention MeSH terms: Etanercept; 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: 851.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis; Arthritis, Psoriasis; Etanercept; Enbrel; Methotrexate; Minimal Disease Activity

Summary:

      The purpose of this study is to learn more about the role of etanercept alone or in
      combination with methotrexate on disease activity in adults with psoriatic arthritis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Subject must have a diagnosis of psoriatic arthritis (PsA) by the Classification
             Criteria for Psoriatic Arthritis (CASPAR) criteria.

          -  Subject has ≥ 3 tender and ≥ 3 swollen joints at screening and at baseline.

          -  Subject has an active psoriatic skin lesion

          -  Subject is naïve to etanercept and any other biologic for the treatment for PsA or
             psoriasis.

          -  Subject has no prior use of methotrexate for PsA.

          -  Subject has no history of tuberculosis

          -  Subject has a negative test for tuberculosis, hepatitis B and C.

        Exclusion Criteria:

          -  Subject has known history of alcoholic hepatitis, nonalcoholic steatohepatitis or
             immunodeficiency syndromes, including human immunodeficiency virus (HIV) infection.

          -  Subject has any active infection (including chronic or localized infections) for which
             anti-infectives were indicated within 4 weeks prior to the first dose of
             investigational product.

          -  Subject has a serious infection, defined as requiring hospitalization or intravenous
             anti-infectives within 8 weeks prior to the first dose of investigational product.
Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Intervention: Lubiprostone; Placebo
Intervention description: Liquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID); Matching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID)
Intervention MeSH terms: Lubiprostone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as
      compared to matching placebo, when administered orally to subjects with chronic idiopathic
      constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of
      fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medically-confirmed diagnosis of chronic idiopathic constipation

          -  Willing to discontinue use of prescribed or over-the-counter (OTC) medication that
             affects gastrointestinal motility during the study

          -  Stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific
             reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors

        Exclusion Criteria:

          -  Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or
             defecation.

          -  Medical/surgical condition that might interfere with the absorption, distribution,
             metabolism, or excretion of the study medication.
Biological Markers of Response to Treatment in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: open-label selective serotonin reuptake inhibitor (SSRI)
Intervention description: Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion.
Intervention MeSH terms: Citalopram; Escitalopram; Selective Serotonin Reuptake Inhibitors; Serotonin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: depression; biology

Summary:

      The purpose of this study is to find out if two tests are useful in predicting whether
      someone with depression will get better when he or she is treated with an FDA approved
      antidepressant medication (either citalopram or escitalopram).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18-65

          -  Meet criteria for current Major Depressive Disorder

          -  Antidepressant medication-free for at least 2 weeks prior to the start of the study

        Exclusion Criteria:

          -  Pregnant or breastfeeding women

          -  Anyone who is suicidal

          -  Anyone with an unstable medical condition (cardiovascular, hepatic, renal,
             respiratory, endocrine, neurological, or hematological), substance abuse problem
             within the past 6 months, psychoses (past or current), hypothyroidism, or hypomania

          -  Anyone currently taking an SSRI

          -  Past intolerance to Lexapro or Celexa
GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
Condition: HIV Infections
MeSH terms: Infections
Intervention: saquinavir [Invirase]; Lopinavir/ritonavir; Emtricitabine/tenofovir disoproxil fumarate; Ritonavir
Intervention description: 1000 milligram (mg) Oral (po) twice daily (bid); Lopinavir/ritonavir 400/100 mg po bid; Emtricitabine/tenofovir disoproxil fumarate 200/300 mg po qd; 100 mg po bid
Intervention MeSH terms: Ritonavir; Lopinavir; Saquinavir; Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 337.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir
      or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human
      immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment.
      Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice
      daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir
      400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study
      treatment is 3-12 months, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  chronic HIV-1 infection;

          -  treatment-naive;

          -  HIV-1 RNA viral load >=10,000copies/mL;

          -  women of childbearing potential must have a negative pregnancy test, and must use
             reliable contraception for the duration of the study and for 90 days after the last
             dose of study medication.

        Exclusion Criteria:

          -  females who are pregnant or breastfeeding;

          -  active hepatitis B infection;

          -  previous treatment with antiretroviral medication;

          -  patients who have received an investigational drug within the last 4 weeks.
Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
Condition: Thyroid Neoplasms
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Intervention: Sorafenib (Nexavar, BAY43-9006); Placebo
Intervention description: Sorafenib 400 mg will be administered orally, twice daily (approximately every 12 hours).; Placebo (2 tablets) will be administered orally, twice daily (approximately every 12 hours).
Intervention MeSH terms: Sorafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 417.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RAI-Refractory; Differentiated; Follicular; Papillary; Hurthle

Summary:

      Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic
      differentiated thyroid cancer refractory to radioiodine
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular
             and Hurthle cell)

          -  Poorly differentiated and other thyroid variants (e.g. insular, tall cell, etc.) are
             eligible provided that the histology has no medullary differentiation nor anaplastic
             features

          -  Progression within 14 months (RECIST [Response Evaluation Criteria in Solid Tumors]
             should be used as a basis for the assessment of disease progression)

          -  RAI (radioactive iodine) refractory

        Exclusion Criteria:

          -  Histologic subtypes of thyroid cancer other than differentiated (i.e. like anaplastic
             and medullary carcinoma, lymphoma or sarcoma)

          -  Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies
             (licensed or investigational) that target VEGF (vascular endothelial growth factor) or
             VEGF Receptors or other targeted agents

          -  Prior anti-cancer treatment for thyroid cancer with use of chemotherapy (low dose
             chemotherapy for radiosensitization is allowed) or Thalidomide or any of its
             derivatives
A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children (6-11 Years) With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Ciclesonide; Placebo; Salbutamol
Intervention description: inhaled Ciclesonide; Ciclesonide placebo-matching inhaler; Salbutamol inhalation powder
Intervention MeSH terms: Ciclesonide; Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1080.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Asthma; Ciclesonide; children

Summary:

      The purpose of this study is to investigate the efficacy of inhaled ciclesonide at three
      different dose levels compared with placebo with respect to pulmonary function, asthma
      symptoms, and use of rescue medication in children aged 6-11 years with asthma. Treatment
      medication will be administered as follows: ciclesonide or placebo will be inhaled once daily
      in the evening. The study consists of a baseline period (2 to 4 weeks) and a treatment period
      (12 weeks). The study provides further data on safety and tolerability of ciclesonide.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  History of asthma for at least 6 months

          -  Ability to show optimal use of MDI, including inhalation technique

          -  Lung function and reversibility within specified limits

        Main Exclusion Criteria:

          -  Concomitant severe diseases

          -  Diseases which are contraindications for the use of inhaled steroids

          -  Two or more inpatient hospitalizations for asthma within the last year

          -  Respiratory tract infection or asthma exacerbation within the last 30 days prior to
             entry into the study

          -  Use of systemic steroids within the last 30 days prior to inclusion (depot steroids 6
             weeks)

          -  Beginning of or change in immunotherapy within the last 6 months prior to inclusion

          -  Inability to follow the procedures of the study
Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B
Condition: Hepatitis B; Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Entecavir; Telbivudine
Intervention description: Entecavir 0.5 mg once daily for 12 weeks.; Telbivudine 600 mg once daily for 12 weeks.
Intervention MeSH terms: Entecavir; Telbivudine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: HBeAg-positive, chronic hepatitis B; telbivudine; entecavir; viral kinetics

Summary:

      This exploratory study is designed to determine the early viral kinetic profile during
      treatment with telbivudine or entecavir at multiple time points over 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18-70 years of age with documented compensated hepatitis B "e" antigen
             (HBeAg)-positive chronic hepatitis B

          -  Able to comply with study regimen and provide written informed consent

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Unwilling to use double barrier method of contraception

          -  Co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or human
             immunodeficiency virus (HIV)

          -  Received Hepatitis B therapy in the past

          -  Use of immunomodulatory therapy in past 12 months

          -  History of or symptoms of hepatic decompensation or pancreatitis

          -  Frequent or prolonged use of potentially hepatotoxic or nephrotoxic drugs

          -  Concurrent medication likely to preclude compliance with schedule of evaluations

          -  Use of other investigational drugs within 30 days of enrollment

          -  Abnormal laboratory values during screening

        Other protocol-defined inclusion/exclusion criteria may apply
Retapamulin as a Decolonizing Agent for MRSA
Condition: MRSA
Intervention: Retapamulin; Placebo Ointment
Intervention description: Retapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%).; The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.
Intervention MeSH terms: Retapamulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 47.0
Sex: All
Minimum age: 9 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: rectal MRSA; mupirocin-resistant nasal MRSA

Summary:

      The purpose of this study is to investigate the efficacy of retapamulin to reduce carriage of
      MRSA via a randomized, double-blind, placebo-controlled clinical study testing retapamulin
      among patients with confirmed mupirocin-resistant nasal and/or rectal MRSA colonization. The
      sample size will include 27 subjects in each of the two arms of the study (retapamulin versus
      placebo) for a total of 54 subjects. Participants who are found to be nasal and/or rectal
      colonized with MRSA will be randomized to receive either retapamulin or placebo applied
      nasally and rectally for a total of 5 days. Nasal and rectal swabs will be collected at
      pre-defined time points during study duration (screening swab, swab one week after completion
      of topical therapy, swab 4 weeks after completion of topical therapy) to assess MRSA
      colonization status. The colonization rates of both groups will be assessed via Fisher's
      Exact Test.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Admission to the general pediatric floor and pediatric intensive care units at NYU
             Langone Medical Center or visit to study team members at ODA clinic (Park Ave
             locations) in Williamsburg Brooklyn.

          2. Ages 9 months to 17 years

          3. Residing in the zip codes which reflect Orthodox Jewish neighborhoods where there is a
             current outbreak of this strain of MRSA.

          4. Nasal and/or rectal culture positive for mupirocin-resistant methicillin-resistant
             Staphylococcus aureus (MRSA)

        Exclusion Criteria:

        An individual who meets any of the following criteria will be excluded from participation
        in this study:

          1. Pregnant or lactating

          2. Unable to appropriately consent

          3. Open sores in either of the study sites (nares or rectum)

          4. Recent surgical procedure to either study site (nares or rectum)

          5. Concurrent use of Rifampin or Trimethoprim/Sulfamethoxazole

          6. Current active MRSA infection

          7. Immunocompromised

          8. Presence of endotracheal tube, tracheostomy tube or other foreign body in upper airway
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Roflumilast; Placebo
Intervention description: 500 mcg, once daily, oral administration in the morning; once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1523.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Roflumilast; COPD; Chronic obstructive pulmonary disease

Summary:

      The aim of the study is to investigate the effect of roflumilast on exacerbation rate and
      pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast
      will be administered orally once daily in the morning at one dose level. The study duration
      will last up to 56 weeks. The study will provide further data on safety and tolerability of
      roflumilast.

      For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673
      (toll free).
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  COPD patients having at least one exacerbation within last year

          -  FEV1/FVC ratio (post-bronchodilator) ≤ 70%

          -  FEV1 (post-bronchodilator) ≤ 50% of predicted

        Main Exclusion Criteria:

          -  COPD exacerbation not resolved at first baseline visit

          -  Diagnosis of asthma and/or other relevant lung disease
A Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers
Condition: Pancreatic Disease
MeSH terms: Pancreatic Diseases
Intervention: ChiRhoStim; Placebo
Intervention description: Human Secretin for Injection; Saline for Injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Genetic End Marker

Summary:

      The following are the study hypothesis:

        -  Secretin administration compared to placebo will result in a statistically significantly
           greater percentage of collected fluid samples being predominantly of exocrine pancreas
           origin when samples are duodenal aspirates.

        -  Secretin administration compared to placebo will result in a statistically significantly
           greater percentage of collected fluid samples meeting the minimum specifications for use
           in the indicated laboratory test of DNA mutational analysis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Documented or suspected diagnosis of chronic pancreatitis or suspected diagnosis of
             pancreatic cancer.

          2. Undergoing Endoscopic Procedure.

          3. Age ≥ 18 years.

          4. Willing and able to sign informed consent, meeting IRB guidelines.

          5. Willing and able to meet all study requirements and obligations.

        Exclusion Criteria:

          1. Ongoing, active pancreatitis at the time of the procedure.

          2. Known adverse reaction to secretin.

          3. Recent (within one month) use of medication that can potentially cause pancreatitis,
             such as metronidazole, tetracycline, sulfonamides.

          4. Use of anticholinergic medication within 7 days of study.

          5. Pregnant women, nursing mothers, or women of childbearing potential not employing
             appropriate contraception. Acceptable methods of birth control are: intrauterine
             device, implantable progesterone device, progesterone intramuscular injection, oral
             contraceptive (started at least one month prior to Visit 1 and continuing for the
             duration of the trial), contraceptive patch, condoms with spermicide or abstinence.

          6. Any medical condition which in the judgment of the Principal Investigator makes
             participation of the patient in the study medically unwarranted.

          7. Known complete obstruction of the pancreatic duct.

          8. Patients who have received an investigational product/drug or device within 30 days
             prior to Visit 1.