bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Etrasimod; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether etrasimod is a safe and effective treatment
      for ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderately to severely active ulcerative colitis defined as a 3-component Mayo Clinic
             score

          -  Evidence of colonic ulcerative colitis activity on endoscopy

        Exclusion Criteria:

          -  Within 30 days prior to randomization, receipt of any of the following for the
             treatment of underlying disease: Non-biologic therapies (eg, cyclosporine, tacrolimus,
             tofacitinib, thalidomide), a non-biologic investigational therapy or an approved
             non-biologic therapy in an investigational protocol

          -  Within 60 days prior to randomization, receipt of any of the following: Infliximab,
             adalimumab, golimumab, certolizumab, vedolizumab, any other investigational or
             approved biologic agent

          -  Any prior exposure to natalizumab, efalizumab, or rituximab
A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration
Condition: Genetic Disorders; Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary; Genetic Diseases, Inborn
Intervention: Recombinant Human C1 Inhibitor
Intervention description: 50 IU/kg "rhC1INH", "IV" injection over 4 to 5 minutes, once weekly over an 8-week treatment period.
Intervention MeSH terms: Complement C1 Inhibitor Protein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Hereditary angioedema ("HAE") is a disease characterized by recurrent tissue swelling
      affecting various body locations. Recent literature shows that patients with frequent attacks
      may benefit from long-term prophylaxis. This study aims to evaluate the safety and
      prophylactic effect of weekly administrations of 50 IU/kg recombinant C1 Inhibitor
      ("rhC1INH").
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged at least 18 years

          -  Signed informed consent

          -  Comfirmed diagnosis of HAE with baseline plasma level of functional C1INH activity of
             less than 50% of normal, and/or proven HAE ,mutation in C1INH gene.

        Exclusion Criteria:

          -  A history of anaphylaxis or severe allergy (i.e. requiring medication) to food,
             proteins and/or drugs.

          -  A history of allergic reactions to C1INH products or rabbit protein.

          -  Any reported SAE related to study drug administration (withdrawal criterium)

          -  Elevated IgE against rabbit dander (>0.35 kU/L; ImmunoCap assay; Phadia)

          -  A diagnosis of acquired C1INH deficiency.

          -  Woman of child bearing potential, pregnancy or breast-feeding

          -  previous treatment within the last 3 months with plasma-derived C1INH

          -  Any clinically significant abnormality in the routine haematology, biochemistry and
             urinalysis

          -  Any condition or treatment that in the opinion of the investigator might interfere
             with the evaluation of the study objectives.

          -  Any changes since screening that would exclude subject based on above exclusion
             criteria.
Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: axitinib; axitinib; axitinib
Intervention description: axitinib 5mg BID (open-label) + axitinib dose titration (blinded); axitinib 5mg BID (open-label) + placebo dose titration (blinded); axitinib 5mg BID (open-label)
Intervention MeSH terms: Axitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 213.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: axitinib or AG-013736 dose titration (increase) renal cell carcinoma; kidney cancer

Summary:

      Axitinib dose titration (giving a higher dose of the drug above its standard starting dose)
      among certain patients may improve the response to treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  metastatic renal cell carcinoma (kidney cancer) with clear cell component

          -  no prior systemic therapy (including no prior adjuvant or neoadjuvant)

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

          -  Blood Pressure < or = 140/90mmHg

        Exclusion Criteria:

          -  brain/CNS metastasis

          -  using more than 2 blood pressure medications
Endothelial Hyperpolarization in Humans
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Intervention: Tetraethylammonium (TEA); L-NG-monomethyl Arginine (L-NMMA); Bradykinin; Sodium nitroprusside; Acetylcholine; Saline; Fluconazole
Intervention description: 5 minute intra-arterial infusion of Tetraethylammonium at 1 mg/min; 5 minute intra-arterial infusion of L-NMMA 8 μmol/min; Intra-arterial infusion of bradykinin at 100, 200, and 400 ng/min. Each dose will be given for 5 minutes.; Intra-arterial infusion of sodium nitroprusside at 1.6 and 3.2 mg/min. Each dose will be given for 5 minutes.; Intra-arterial infusion of acetylcholine at 7.5, 15 and 30 μg/min. Each dose will be given for 5 minutes.; 5 minute intra-arterial infusion of 0.9% saline at 2.5ml/min; 5 minute intra-arterial infusion of fluconazole at 0.4 mg/L/min
Intervention MeSH terms: Fluconazole; Nitroprusside; Tetraethylammonium; Acetylcholine; Bradykinin; omega-N-Methylarginine; Kininogens
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 174.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: hyperlipidaemia; EDHF; FMD

Summary:

      The purpose of this study is to elucidate the role Endothelium-Derived Hyperpolarizing Factor
      (EDHF) plays in dilating blood vessels and whether it differs between healthy people and
      those with high cholesterol. A second purpose of the study is to determine the identity of
      EDHF.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hyperlipidemic (LDL > 140)

          -  Healthy Volunteer

        Exclusion Criteria:

          -  Pregnancy

          -  Diabetes mellitus

          -  Cardiovascular Disease

          -  Hypertension

          -  Use of any regular medications

          -  Renal insufficiency

          -  Smoking (current or within the past 5 years)

          -  Bleeding disorder
Study of CC-5013 to Evaluate Safety, Pharmacokinetics and Effectiveness for Japanese Patients With Symptomatic Anemia Associated With Myelodysplastic Syndrome With a Del(5)(q31-33) Abnormality.
Condition: Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Lenalidomide
Intervention description: Oral 10mg daily on Days 1-21 days every 28 days until disease progression/relapse or CC-5013 is permanently discontinued for any reason for up to 156 weeks (3 years).
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Myelodysplastic Syndromes; Lenalidomide

Summary:

      The purpose of this clinical experience study is to determine whether CC-5013 is safe and
      effective (to include studying the process by which a drug is absorbed, distributed,
      metabolized, and eliminated by the body [pharmacokinetics]) in Japanese subjects with low- or
      intermediate-1-risk MDS (IPSS risk categories) associated with a deletion 5(q31-33)
      abnormality and symptomatic anemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must understand and voluntarily sign an informed consent form.

          -  Age ≥ 20 years at the time of signing the informed consent form.

          -  Must be able to adhere to the study visit schedule and other protocol requirements.

          -  Diagnosis of Myelodysplastic Syndrome (MDS) that meets International Prognostic
             Scoring System (IPSS) criteria for low- or intermediate-1-risk disease associated with
             a deletion 5(q31-33) abnormality

          -  Symptomatic anemia secondary to MDS defined as:Untransfused Hb level < 10.0 g/dL and a
             Functional Assessment of Cancer Therapy (FACT)-anemia subscale score of ≤ 74 or
             Transfusion dependent anemia

        Exclusion Criteria:

          -  Pregnant or lactating females.

          -  Any condition, including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he/she were to participate in the study.

          -  Prior therapy with lenalidomide.

          -  Patients with any of the following laboratory abnormalities within 14 days of starting
             study drug: Absolute Neutrophil Count (ANC) < 750 cells/μL (0.75 x 10^9/L) Platelet
             count < 50,000/μL (50x10^9/L) Serum creatinine > 2.5 mg/dL Aspartate Aminotransferase
             (AST) or Alanine Aminotransferase (ALT) > 3.0 x Upper Limit of Normal (ULN)
A Study Comparing Eribulin Mesylate and Ixabepilone in Causing or Exacerbating Neuropathy in Participants With Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Eribulin Mesylate; Ixabepilone
Intervention description: E7389 (eribulin mesylate) given at a dose of 1.4 mg/m^2 as a 2 to 5 minute intravenous (IV) bolus on Days 1 and 8 of a 21-day cycle.
The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment.; Ixabepilone given at a starting dose of 32 or 40 mg/m^2 (as per approved labeling) as a 3-hour IV infusion on Day 1 of a 21-day cycle.
The Treatment Phase will include six cycles. Patients may enter the Extension Phase for additional cycles following the sixth cycle of treatment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Oncology

Summary:

      The purpose of this study in patients with advanced breast cancer is to compare the incidence
      and severity of neuropathy adverse events for the two treatment groups (eribulin versus
      ixabepilone) using National Cancer Institute Common Terminology Criteria for Adverse Events
      (NCI CTCAE version 3.0) grading.
    

Eligibility criteria:

        Inclusion criteria:

        1. Female subjects with confirmed locally recurrent or metastatic carcinoma of the breast
        who have received prior taxane therapy and at least one prior cytotoxic chemotherapy
        regimen for advanced disease.

        Exclusion criteria:

          1. Subjects who have received prior ixabepilone therapy.

          2. Subjects with prior participation in an eribulin clinical study, even if not assigned
             to eribulin treatment.

          3. Subjects with pre-existing neuropathy Grade greater than or equal to 2.

          4. Subjects with a history of diabetes mellitus Type 1 or 2.

          5. Subjects with bilateral mastectomy which included bilateral axillary lymph node
             dissection.

          6. Subjects with missing digits required for vibration assessment.

          7. Subjects with any other concurrent diseases or conditions that would be expected to
             interfere with neuropathy assessments, which may include vitamin deficiency, sequelae
             of cerebrovascular disease, thyroid insufficiency, lumbar or cervical radiculopathy,
             or alcoholic or inflammatory neuropathy.
Lithium in Multiple System Atrophy
Condition: Multiple System Atrophy
MeSH terms: Multiple System Atrophy; Shy-Drager Syndrome; Atrophy
Intervention: Lithium Carbonate; Placebo
Intervention description: Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
Intervention MeSH terms: Lithium Carbonate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: MSA; Lithium; Lithium carbonate; MSA-P; MSA-C

Summary:

      The purpose of this study is to determine safety and tolerability of the treatment with
      lithium in Multiple System Atrophy. Moreover, clinical symptoms, neuronal loss, quality of
      life and depressive symptoms, will be considered to further investigate the effect of lithium
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of probable MSA (Gilman, et al. 2008)

          -  Age ≥18, <80

        Exclusion Criteria:

          -  Heart failure

          -  Liver disease

          -  Kidney failure

          -  Thyroid disease

          -  Sick sinus syndrome and/or significant ECG alterations

          -  Hyposodemia

          -  Treatment with diuretics

          -  Treatment with haloperidol and/or other antipsychotics

          -  Treatment with NSAIDs or corticosteroids

          -  Treatment with ACE inhibitors

          -  Treatment with aminophyllines

          -  Treatment with mannitol

          -  Pregnancy and/or breastfeeding

          -  Acute diseases that might interfere with the trial
A Study in Asymptomatic HIV Infected Patients to Investigate Pharmacodynamics, Pharmacokinetics, Safety and Toleration of UK-453,061
Condition: HIV-1
Intervention: UK-453,061; UK-453,061
Intervention description: Placebo BID, Placebo QD, UK-453,061 10 mg BID, 30 mg BID, 100 mg BID or 500 mg QD for 7 days; Placebo BID, Placebo QD, UK-453,061 100 mg QD, 500 mg BID or 750 mg QD for 7 days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 49.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      A phase 2a study to investigate the effects of 7-day monotherapy of UK-453,061 on viral load
      response in asymptomatic human immunodeficiency virus (HIV) infected subjects, to assess the
      dose-response relationship, and to assess the pharmacokinetics (PK), safety and tolerability
      of UK-453,061 in asymptomatic HIV infected subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Asymptomatic HIV-1 infected male and patients aged 18-55 years inclusive.

          -  Patients with virus not containing NNRTI resistant mutations as determined by the
             VircoGEN virtual phenotyping essay.

        Exclusion Criteria:

          -  Patients with a CD4 count less than 250 cells/mm3.

          -  Patients whose HIV infection has been diagnosed less than 3 months prior to screening,
             or for whom there is evidence of recent seroconversion.

          -  Patients with an HIV viral load less than 5000 copies/ml using RT-PCR(Roche Amplicor
             v1.5).
Celecoxib for Thyroid Eye Disease
Condition: Thyroid Eye Disease
MeSH terms: Eye Diseases; Graves Ophthalmopathy; Thyroid Diseases
Intervention: Celecoxib; artificial tears
Intervention description: celecoxib 100mg PO twice per day for 3 months; Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke.
Intervention MeSH terms: Celecoxib; Lubricant Eye Drops
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Thyroid eye disease (TED) is an autoimmune disorder in which the immune system attacks
      orbital tissues, resulting in characteristic changes in eyelid position, globe position in
      the orbit, extraocular muscle balance, and optic nerve function. TED is a potentially
      blinding disease, and current treatments largely consist of nonspecific reduction of
      inflammation using corticosteroids or radiation therapy. Regardless of treatment, once TED
      progresses from its inflammatory phase to a more fibrotic, resolution phase, the orbital
      changes become fixed and can be modified only by surgery.

      The investigators propose to treat a cohort of patients with active TED using a selective
      COX-2 inhibitor, celecoxib, and to compare these patients to an observational control group.
      The investigators hypothesize that celecoxib will reduce the severity of disease and/or
      prevent progression to proptosis, diplopia, and corneal exposure or compressive optic
      neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recent diagnosis of thyroid eye disease (within the past 3 months)

          -  Have ocular symptoms or signs of TED with a clinical activity score (CAS) of at least
             3

        Exclusion Criteria:

          -  Pregnancy

          -  Previous treatment with corticosteroid for TED for >2wks

          -  Previous treatment with orbital radiation for TED

          -  Impaired renal function

          -  Impaired hepatic function

          -  Treatment with antihypertensive medications except beta-blockers

          -  History of congestive heart failure, cardiac valvular disease, or coronary artery
             disease

          -  Allergy to NSAID or previous adverse reaction (ie. GI bleeding)

          -  Vision loss due to compressive optic neuropathy
To Investigate Efficacy and Safety of Pemetrexed as Second or Third Line Therapy in Patients With Non-small Cell Lung Cancer (NSCLC)
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed 500 mg/m2; Pemetrexed 1000 mg/m2
Intervention description: 500 mg/m2, intravenous (IV), every 21 days, one year from registration date; 1000 mg/m2, intravenous (IV), every 21 days, one year from registration date
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 226.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To investigate efficacy and safety of pemetrexed as second or third line therapy in patients
      with non-small cell lung cancer (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical stage III or IV

          -  Previously treated with one or two chemotherapeutic regimens

          -  Performance status: 0-2

        Exclusion Criteria:

        - Inability or unwillingness to take folic acid or vitamin B12 supplementation
TXA127 for the Treatment of Severe COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: TXA127; Placebo
Intervention description: 0.5 mg/kg per day; 0.5 mg/kg per day
Intervention MeSH terms: Angiotensin I (1-7)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blinded, placebo-control, randomized clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; multi-organ failure; acute kidney injury

Summary:

      The purpose of this study is to determine if administration of angiotensin-(1-7) (TXA127)
      prevents acute kidney injury and deterioration into multi-organ failure in patients with
      severe COVID-19. Participants will undergo a 10-day treatment with either placebo or study
      drug. The drug will be administered intravenously for 3 hours once each day for 10 days
      consecutively.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe COVID-19: Adult patients admitted to the hospital through the Emergency
             Department (ED) requiring oxygen therapy (any level) to maintain oxygen saturation
             (SaO2) > 90%

          -  COVID positive by polymerase chain reaction (PCR) on hospital admission

          -  Hospitalized patients aged 18 years or greater

        Exclusion Criteria:

          -  Pre-existing chronic kidney disease

          -  New use of or change in dose of ACE-inhibitors or angiotensin receptor blocker (ARB)
             within the last 6 months

          -  Acute kidney injury at the time of enrollment defined as either increase pf serum
             creatinine by more than 50% or 0.3 mg/dL above baseline or estimated creatinine
             clearance (by MDRD) of less than 60 ml/min (if no baseline serum creatinine available)

          -  Pregnant and breastfeeding women

          -  Contraindicated medications: new use or change of medications from start of trial
             (start of an ACE inhibitor or ARB within 6 months of trial).