bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain
Condition: Constipation
MeSH terms: Constipation
Intervention: MOA-728; Placebo
Intervention description: Oral Capsules; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the safety and dose-response relationship of
      N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects
      administered MOA-728 who have chronic pain that is not due to cancer, and who have
      opioid-induced bowel dysfunction (OIBD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult Outpatients with opioid-induced bowel dysfunction and chronic pain, which is not
             due to malignant cancer.

          -  Taking oral, transdermal, intravenous, or subcutaneous opioids.

          -  Willingness to discontinue all pre-study laxative therapy and use only study permitted
             rescue laxatives.

        Exclusion Criteria:

          -  History of chronic constipation before the initiation of opioid therapy.

          -  Other GI disorders known to affect bowel transit.

          -  Women who are pregnant, breast feeding, or plan to become pregnant.
Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Immunoblastic Lymphadenopathy
Intervention: cyclosporine
Intervention description: Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6, starting dose will begin at cyclosporine 3 mg/kg by mouth two times a day (PO BID)) and 150-250 ng/mL during the maintenance period (weeks 7-36, maintenance dose will begin at cyclosporine 2 mg/kg PO BID) in the absence of renal toxicity
Intervention MeSH terms: Cyclosporine; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: angioimmunoblastic T-cell lymphoma

Summary:

      RATIONALE: Cyclosporine may help the immune system slow the growth of angioimmunoblastic
      T-cell lymphoma.

      PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients
      with recurrent or refractory angioimmunoblastic T-cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of angioimmunoblastic T-cell lymphoma (recurrent or refractory) based on
             histologic examination.

          -  At least one objective measurable or evaluable disease parameter.

          -  Have failed at least one type of treatment: chemotherapy, auto-transplant, or steroid
             treatment. Patients may not receive concurrent chemotherapy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

          -  Adequate renal function as indicated by creatinine <= 1.5 the upper limit of normal
             (ULN).

          -  Adequate liver function as indicated by alkaline phosphatase, Aspartate
             Aminotransferase (AST), and Alanine Aminotransferase (ALT) <= 2x the upper limit of
             normal.

          -  Total bilirubin <= 2x the upper limit of normal.

          -  Age 18 or older.

        Exclusion Criteria:

          -  Prior cyclosporine or Tacrolimus (FK506).

          -  Prior allogeneic transplant.

          -  Evidence of active infection.

          -  Congestive heart failure, kidney failure, liver failure, or other severe
             co-morbidities.

          -  Evidence of active neurological impairment.

          -  Previous history of hypersensitivity to cyclosporine and/or Cremorphor EL
             (polyoxyethylated oil).

          -  History of other malignancies (other than cured carcinomas in situ of the cervix or
             basal cell carcinoma of the skin).

          -  pregnant or breastfeeding women.

          -  Human immunodeficiency virus (HIV) positive.
Study Evaluating 2 Dosing Regimens Of TRU-015 In Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: TRU-015; Methylprednisolone; Prednisone; TRU-015; Methylprednisolone; Prednisone; TRU-015; Methylprednisolone; Prednisone
Intervention description: IV 800 mg TRU-015 at Baseline (both arms) and Week 24 (both arms); corresponding IV Placebo at Week 12 and Week 36 (both arms).; IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 1a) and Week 24 (both arms); corresponding IV Placebo at Week 12 (Arm 1b) and Week 36 (both arms).; Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 1a), and Week 24 (both arms); corresponding Oral Placebo at Week 12 (Arm 1b) and Week 36 (both arms); IV 800 mg TRU-015 at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 24 (both arms).; IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (both arms), and Week 36 (both arms); corresponding IV Placebo at Week 36 (both arms).; Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 2a) and Week 36 (both arms); corresponding Oral Placebo at Week 12 (Arm 2b) and Week 24 (both arms).; IV 800 mg TRU-015 at Week 24 (both arms) and Week 36 (arm 3a); corresponding IV Placebo at Baseline (both arms), Week 12 (both arms) and Week 36 (arm 3b).; IV 100 mg Methylprednisolone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms), and Week 36 (arm 3a); corresponding IV Placebo at Week 12 (arm 3b) and Week 36 (arm 3b).; Oral 20 mg tablets Prednisone at Baseline (both arms), Week 12 (arm 3a), Week 24 (both arms) and Week 36 (arm 3a); corresponding Oral Placebo at Week 12 (Arm 3b) and Week 36 (arm 3b).
Intervention MeSH terms: Prednisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: active; rheumatoid; arthritis; anti CD20

Summary:

      This study will evaluate the efficacy and safety of two dosing regimens of a compound known
      as TRU-015 in combination with methotrexate (MTX) in patients with active rheumatoid
      arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of active seropositive rheumatoid arthritis on a stable dose of
             methotrexate (7.5-25 mg weekly) for at least 12 weeks with or without a history of
             anti-TNF use.

        Exclusion Criteria:

          -  Any prior use of rituximab or other B cell depleting agents.

          -  Any significant health problem other than rheumatoid arthritis

          -  Clinically significant laboratory abnormalities
Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Intervention: PF-04236921; PF-04236921; PF-04236921; PF-04236921
Intervention description: subcutaneous injection; administered at day 1, weeks 8, 16.; subcutaneous injection; administered at day 1, weeks 8, 16.; subcutaneous injection; administered at day 1, weeks 8, 16.; subcutaneous injection; administered at day 1, weeks 8, 16
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 183.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: double-blind; placebo-controlled; multicenter; dose-ranging; efficacy; safety; lupus.

Summary:

      The objective of this study is to evaluate and compare efficacy of 3 dose levels of
      PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic
      Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory
      measures as well.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects between ages of 18 and 75 years old at time of signing
             consent.

          -  Have a clinical diagnosis of SLE according to 1997 update on the revised 1982 American
             College of Rheumatology (ACR) criteria.

          -  Have a unequivocally positive anti-nuclear antibody (ANA) test result.

          -  Active disease at screening defined by both: SLEDAI-2K score greater than or equal to
             6 and BILAG Level A disease in more than or equal to 1 organ system (except renal or
             central nervous system) or BILAG B disease in more than or equal to 2 organ systems if
             no level A disease in present.

        Exclusion Criteria:

          -  Any prior history of treatment with PF-04236921, or anti-IL-6 agent;

          -  Have received any of the following within 364 days of day 1: a biologic
             investigational agent other than B cell targeted therapy; required 3 or more courses
             of systemic corticosteroids for concomitant conditions; history of previously
             untreated or current evidence of active or untreated latent infection with
             Tuberculosis (TB), evidence of prior untreated or currently active TB by chest
             radiography, residing with or frequent close contact with an individual with active
             TB.
A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: LY2127399; Placebo
Intervention description: Administered SC every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).; Administered subcutaneously (SC) every 4 weeks over a 24-week period (Weeks 0, 4, 8, 12, 16, and 20).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Arthritis

Summary:

      To assess the efficacy of LY2127399 versus placebo using American College of Rheumatology
      (ACR)50 response scale at 24 weeks
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have given written informed consent

          -  Women must not be at risk to become pregnant during study participation

          -  Diagnosis of Rheumatoid Arthritis (RA)

          -  Current, regular use of Methotrexate, at a stable dose

          -  Other criteria to be reviewed by study doctor

        Exclusion Criteria:

          -  Use of excluded medications(reviewed by study doctor)

          -  Have not failed biologic tumor necrosis factor-alpha (TNF-α) inhibitor therapy

          -  Have had recent or ongoing infection which, in the opinion of the study doctor put
             patient at an unacceptable risk for participation in the study

          -  Evidence of tuberculosis

          -  Have systemic inflammatory condition other than RA, such as juvenile RA, Crohn's
             disease, ulcerative colitis, psoriatic arthritis or seronegative spondyloarthropathy

          -  Other criteria to be reviewed by study doctor
Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Certolizumab Pegol; Placebo
Intervention description: Pharmaceutical Form: solution for injection in pre-filled syringe
Route of Administration: subcutaneous use; Matching Placebo to Certolizumab Pegol
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 176.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic plaque psoriasis, anti TNFα; CDP870, Cimzia

Summary:

      A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo,
      administered during 12 weeks, to patients suffering from moderate to severe chronic plaque
      psoriasis, extended by a 12 to 24 week follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult men and women > 18 years

          -  Subjects with chronic plaque psoriasis stable for at least 3 months and moderate to
             severe for at least 6 months

          -  Subjects with Psoriasis Area and Severity Index (PASI) ≥ 12 and Body Surface Area
             (BSA) ≥ 10 %

          -  Subjects were candidates for systemic psoriasis therapy and/or phototherapy and/or
             photochemotherapy

        Exclusion Criteria:

          -  Subjects with an erythrodermic, guttate, palmar or plantar, generalized pustular form
             of psoriasis

          -  A history of chronic infection, recent serious or life-threatening infection (within
             six months, including herpes zoster), or any current sign or symptom that may indicate
             an infection (e.g. fever, cough);

          -  White blood cell counts less than 4000/mm^3 or more than 20000/mm^3

          -  Suspected or diagnosed demyelinating disease of the central nervous system (e.g.
             multiple sclerosis or optic neuritis)

          -  Systemic Lupus

          -  Non respect of adequate wash out periods for treatments that might have an impact on
             the disease

          -  Any associated disease that could be impacted by the study treatment intake

          -  Any other condition, which in the Investigator's judgment would make the subject
             unsuitable for inclusion in the study
Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) With Hodgkin's Disease
Condition: Lymphoma
MeSH terms: Hodgkin Disease
Intervention: Interferon-2A; Adriamycin; Bleomycin; Velban; Dacarbazine
Intervention description: 4 (x106 IU/m^2) subcutaneously on days 1-4.; 25 mg/m^2 by vein on day 4.; 10 mg/m^2 by vein on day 4.; 6 mg/m^2 by vein on day 4.; 375 mg/m^2 by vein on day 4.
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Doxorubicin; Liposomal doxorubicin; Bleomycin; Dacarbazine; Vinblastine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Healthy volunteers: No
Keywords: Lymphoma; Hodgkin's Disease; Stage III and IV; Adriamycin; Doxorubicin; Rubex; Bleomycin; Bleomycin Sulfate; BLM; Dacarbazine; DTIC-DOME; Interferon-2A; Interferon-Alfa-2a; Roferon-A; Velban; Vinblastine

Summary:

      This is a clinical research study of interferon (IFN) plus chemotherapy with the standard
      combination of Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD). The treatment will be
      given to patients with Hodgkin's disease. The study will look at whether adding IFN to ABVD
      improves the immune response against Hodgkin's disease, and will determine whether the
      toxicity of ABVD is increased by adding IFN.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Hodgkin's disease patients who relapse after radiation therapy alone, or in
             combination with Novantrone, Oncovin, Velban, and Prednisone (NOVP); and previously
             untreated patients with stage III and IV who are eligible for standard ABVD therapy.

          2. Must have adequate bone marrow reserve Absolute neutrophil count (ANC) > 1,000/uL,
             Platelets > 100,000

          3. Left ventricular ejection fraction (LVEF) >/= 50%, serum creatinine < 2mg/dl, serum
             bilirubin < 2mg/dl

        Exclusion Criteria:

          1. No prior therapy with Mustargen Oncovin Procarbazine Prednisone (MOPP).

          2. No severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and
             asthma.
Safety and Effectiveness of Raltegravir Plus Darunavir/Ritonavir in Treatment-Naive HIV-Infected Adults
Condition: HIV-1 Infections
Intervention: Raltegravir; Darunavir/Ritonavir
Intervention description: 400 mg tablet taken orally twice daily; 800 mg Darunavir/100 mg Ritonavir tablet taken orally once daily
Intervention MeSH terms: Ritonavir; Darunavir; Raltegravir Potassium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment Naive

Summary:

      The purpose of this study is to assess the effectiveness and safety of an antiretroviral
      therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as
      first-line therapy in treatment-naïve participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1-infected

          -  Plasma HIV-1 RNA of at least 5,000 copies/mL within 90 days prior to study entry

          -  HIV genotype (for reverse transcriptase and protease) performed at any time prior to
             study entry. More information on this criterion can be found in the protocol.

          -  ARV drug-naive. More information on this criterion can be found in the protocol.

          -  Negative result from a hepatitis B surface antigen test performed within 90 days prior
             to study entry

          -  Agree to use one form of medically-accepted contraceptive throughout the study and for
             60 days after stopping study treatment. More information on this criterion can be
             found in the protocol.

        Exclusion Criteria:

          -  Serious illness requiring systemic treatment and/or hospitalization for at least 7
             days prior to study. More information on this criterion can be found in the protocol.

          -  Screening HIV genotype obtained any time prior to study entry with more than one DRV
             resistance-associated mutation [RAM] (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P,
             I84V, and L89V) or L76V alone

          -  Known major integrase inhibitor RAM(s), including N155H, Q148H/R/K, Y143C/R, and G140S

          -  Severe renal insufficiency requiring hemodialysis or peritoneal dialysis

          -  Treatment with immunomodulators within 30 days prior to study entry. More information
             on this criterion can be found in the protocol.

          -  Current medications that are prohibited with any study medications. More information
             on this criterion can be found in the protocol.

          -  Known allergy/sensitivity to study drugs or their formulations. A history of sulfa
             allergy is not an exclusion.

          -  Active drug or alcohol use or dependence that, in the opinion of the investigator,
             would interfere with the study.

          -  Certain abnormal laboratory results. More information on this criterion can be found
             in the protocol.

          -  Pregnant or breastfeeding
Nitric Oxide to Treat Pulmonary Embolism
Condition: Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Intervention: Inhaled Nitric Oxide; Sham
Intervention description: Nitric Oxide + oxygen; Nitrogen + Oxygen
Intervention MeSH terms: Nitric Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pulmonary embolism clot

Summary:

      This is a randomized study to treat subjects diagnosed with pulmonary embolism with inhaled
      nitric oxide or placebo (oxygen).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >/= 18

          -  Pulmonary imaging-proven PE, as interpreted by local radiologist

          -  At least one predictor of RV dysfunction:

               1. echocardiography with RV dilation or hypokinesis,

               2. estimated RVSP >40mm HG,

               3. RV>LV on CTPA,

               4. elevated troponin I (>0.1 ng/mL) or natriuretic peptide (BNP > 90 pg/mL),

               5. screening bedside cardiac ultrasound with color flow capability that shows RV
                  dysfunction,

               6. RV strain on ECG

          -  Plan to admit to a bed with telemetry capability

        Exclusion Criteria:

          -  Vasopressor support at time of enrollment

          -  Pregnancy

          -  Plan by clinical care team to use lytic or surgical embolectomy

          -  Plan by clinical team to use platelet inhibiting drugs

          -  Contraindication to anticoagulation

          -  Altered mental status such that the patient is unable to provide informed consent

          -  Inability to use a nasal cannula or face mask

          -  Comfort care measures instituted

          -  Supplemental oxygen requirements greater than can be administered via nasal cannula in
             order to maintain Sa)2 > 80%

          -  Pneumothorax with decompression

          -  Serum MetHb > 10%

          -  Recent use of drugs known to increase cGMP

          -  Use of nitroprusside or nitroglycerin within the last 4 hours

          -  Use of any other nitrates with in the past 24 hours

          -  Use of a fibrinolytic medicine within the past 14 days