bioihbjkbjnl/mcl2 huggingface dataset:
Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: LX3305; LX3305 Placebo; Methotrexate
Intervention description: Daily oral intake of LX3305 for 14 days.; Matching placebo dosing with daily oral intake for 14 days.; Once weekly stable-dose methotrexate.
Intervention MeSH terms: Methotrexate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the effect of LX3305 on methotrexate (MTX)
      pharmacokinetics and to evaluate the safety and tolerability of LX3305 given over 14 days in
      subjects with stable rheumatoid arthritis that are receiving stable doses of MTX.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females ≥ 18 years old

          -  Must be willing to practice 2 adequate methods of contraception for the duration of
             the study

          -  Rheumatoid arthritis present for at least 3 months; functional class I, II, or III as
             defined by ACR criteria

          -  Treatment with methotrexate (7.5 to 25 mg per week) for at least the last 3 months,
             and currently receiving stable dose methotrexate for at least one month prior to the
             start of the study

          -  Ability to provide written informed consent

        Exclusion Criteria:

          -  Women who are pregnant or nursing

          -  History of other current inflammatory arthritis

          -  History of opportunistic infection

          -  History of recurrent infections or current infection 2 weeks prior to start of study

          -  Presence of significant, uncontrolled medical problems

          -  Treatment with any disease-modifying anti-rheumatoid drugs other than methotrexate
             within 4 weeks prior to start of study

          -  Use of chondroitin sulfate, glucosamine sulfate, minocycline, or matrix
             metalloproteinase inhibitors, H-2 blockers, proton pump inhibitors, or misoprostol
             within 4 weeks prior to study start

          -  Receipt of live vaccine within 8 weeks prior to study start

          -  Rheumatoid arthritis, functional class IV as defined by ACR criteria
Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex
Condition: Cystic Fibrosis; Burkholderia Cepacia Infection
MeSH terms: Burkholderia Infections; Cystic Fibrosis; Fibrosis
Intervention: TOBI
Intervention description: New inhalation devices such as the podhaler can administer tobramycin inhalation powder TIP/TOBI and achieve very high sputum drug levels. TOBI will be administered using the Podhaler
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: inhaled antibiotics

Summary:

      The objective of this study is to determine if tobramycin inhalation powder (TIP) can reduce
      the amount of Burkholderia Cepacia Complex (BCC) species - type of bacteria, in the sputum of
      cystic fibrosis patient.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 6 years or older

          -  Diagnosis of CF based on the following: sweat chloride>60 mEq/L or genotype with 2
             identifiable mutations consistent with CF; and one or more clinical features
             consistent with CF.

          -  Chronically infected with a Burkholderia cepacia complex species (>50% of respiratory
             specimens positive in the 24 months prior to screening).

          -  Able to produce sputum (expectorated or induced).

          -  Able to reproducibly perform pulmonary function testing.

          -  Written informed consent provided.

        Exclusion Criteria:

          -  Post lung transplantation.

          -  Pregnancy.

          -  Acute exacerbation requiring IV or oral antibiotics within 14 days

          -  Patients currently receiving inhaled tobramycin/TOBI

          -  A septic or clinically unstable patient, as determined by the investigator.
Effects Of CP-690,550 (Tasocitinib) On Cholesterol Metabolism In Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CP-690,550 (tasocitinib)
Intervention description: CP-690,550 (tasocitinib) dosed at 10 mg BID for 6 weeks in patients with active rheumatoid arthritis
Intervention MeSH terms: Tofacitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cholesterol metabolism; Cholesterol flux; Rheumatoid Arthritis; Tasocitinib; CP-690; 550

Summary:

      The purpose of study is to explore the effect of CP-690,550 (tasocitinib) on cholesterol
      metabolism in patients with active rheumatoid arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females, 18 years of age or older with active rheumatoid arthritis; Or male
             and female healthy volunteers 18 years of age and older

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  Clinically significant systemic disease (other than RA for RA arm)

          -  Use of lipid-regulating agents
A Study of Dalotuzumab (MK-0646) in Breast Cancer Patients (MK-0646-013)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: dalotuzumab (MK0646)
Intervention description: Single intravenous infusion
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study to evaluate the response of growth factor signatures (GFS) to a single dose of
      dalotuzumab in participants with triple negative (TN) or estrogen receptor (ER)-positive
      luminal B breast cancer. The primary hypothesis is that dalotuzumab will induce a decrease in
      the GFS in at least 40% of participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has operable stage I-IIIa breast cancer of the following subtypes: (1)
             estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human
             epidermal growth factor receptor 2 (HER2)-negative breast cancer; (2) ER-positive
             tumor meeting one of the following criteria: histologic grade 3; histologic grade 2
             and PR-negative; histologic grade 2 and Ki67 antigen ≥10%. Tumor is at least 2 cm in
             diameter as assessed by physical or radiographic exam

          -  Participant is female and ≥18 years of age

        Exclusion Criteria:

          -  Participant is pregnant, breastfeeding or planning to become pregnant while in the
             study

          -  Participant has received prior chemotherapy, biological therapy or radiation

          -  Participant has participated in a clinical trial in the last 30 days

          -  Participant has a history of drug or alcohol abuse in the last year

          -  Participant is human immunodeficiency virus (HIV) positive. Patient has a history of
             Hepatitis B or C

          -  Participant has poorly controlled diabetes mellitus
A Safety and Tolerability Study of MEDI-570 in Systemic Lupus Erythematosus
Condition: Lupus Erythematosus, Systemic
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Placebo; MEDI-570 0.03 MG; MEDI-570 0.1 MG; MEDI-570 0.3 MG; MEDI-570 1 MG
Intervention description: A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.; A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.; A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.; A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.; A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Systemic lupus erythematosus; SLE; MEDI-570

Summary:

      The purpose of this study is to evaluate the safety and tolerability of MEDI-570 in adult
      subjects with moderately to severely active systemic lupus erythematosus (SLE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet or have met at least 4 of the 11 revised American College of Rheumatology (ACR)
             classification criteria for systemic lupus erythematosus (SLE)

          -  Score greater than or equal to (>=) 6 points on the Systemic Lupus Erythematosus
             Disease Activity Index 2000 (SLEDAI-2K) at Screening

          -  Ability to complete the study period, including follow-up period through Day 169

          -  Willingness to forego other forms of experimental treatment during the study.

        Exclusion Criteria:

          -  History of cancer except basal cell carcinoma treated with apparent success with
             curative therapy >=1 year before randomization into the study

          -  Evidence of active or latent tuberculosis (TB)

          -  History of primary immunodeficiency

          -  Evidence of infection at any time with hepatitis B or C virus or human
             immunodeficiency virus (HIV)-1 or HIV-2, or active infection with hepatitis A, as
             determined by results of testing at Screening

          -  History of sepsis or serious, recurrent, chronic infection, current signs and symptoms
             of clinically significant chronic infection, or recent (within 6 months before
             Baseline visit) serious infection

          -  Any history or evidence of opportunistic infection within 6 months of Screening
             including severe cytomegalovirus (CMV) or herpetic infections (such as disseminated
             herpes, herpes encephalitis, ophthalmic herpes)

          -  Receipt of cyclophosphamide (intravenous or oral) within 6 months of Screening

          -  Have any absolute contraindications to skin punch biopsies, for example, a history of
             coagulation disorders.
Treatment of Language and Memory in Patients With Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Spaced Retrieval Training
Intervention description: Increasing time to remember important information.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease; Memory; Treatment

Summary:

      The purpose of this study is to collect data on the effects of behavioral interventions for
      memory and communication deficits in persons taking cholinesterase inhibitors compared with
      the effects of cholinesterase inhibitors alone. Initial testing will include a written case
      history, tests of communication skills, and interviews with the participants, family, and
      staff caregivers to help select potential goals for treatment. Participants will be randomly
      selected to participate in Group A (control) or Group B (intervention). Group A will use a
      Caregiver Checklist for eight weeks to identify any increase or decrease in the occurrence of
      the identified communication deficits. Group B will have 16 treatment sessions by a Speech
      Language Pathologist during the eight-week period. A post test will be administered to all
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Alzheimer's Disease (middle stage)

        Exclusion Criteria:

          -  None
Pharmacokinetics and Hepatic Safety of EGCG
Condition: Uterine Fibroids
MeSH terms: Leiomyoma
Intervention: Epigallocatechin gallate (EGCG); Clomiphene Citrate; Letrozole
Intervention description: 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months; 100 mg for 5 days; 5 mg for 5 days
Intervention MeSH terms: Letrozole; Epigallocatechin gallate; Clomiphene; Enclomiphene; Zuclomiphene
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The 36 women will be randomized to one of the following groups:
EGCG daily alone.
EGCG daily with clomiphene citrate 100mg for 5 days.
EGCG daily with letrozole 5mg for 5 days.
Masking: None (Open Label)
Enrollment: 39.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without
      uterine fibroids.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy women ≥18 to ≤40 years of age with or without uterine fibroids

          2. Must use a double-barrier method for contraception

        Exclusion Criteria:

          1. Subjects using green tea/EGCG within 2 weeks prior to study enrollment

          2. Known liver disease (defined as AST or ALT>2 times normal, or total bilirubin >2.5
             mg/dL).

          3. History of alcohol abuse (defined as >14 drinks/week) or binge drinking of ≥ 6 drinks
             at one time).

          4. Subject using hormonal contraceptives

          5. Subjects who are pregnant or breastfeeding

          6. Known hypersensitivity to the study drugs

          7. Any chronic disease
A Study to Evaluate the Effect of IV Doses of Rivipansel in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
Condition: Moderate Hepatic Impairment; Normal Hepatic Function
MeSH terms: Liver Diseases
Intervention: Rivipansel
Intervention description: A single dose of IV Rivipansel over 20 minutes
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatic Impairment; Rivipansel

Summary:

      The purpose of this study is to determine the effect of hepatic impairment on rivipansel PK
      and safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects of non-childbearing potential or male subjects

               -  Body Mass Index (BMI) of 17.5 to 40.0 kg/m2

               -  Normal Hepatic function for the healthy subjects

               -  Stable Hepatic Impairment for the subjects with moderate hepatic impairment

        Exclusion Criteria:

          -  Treatment with an investigational drug within 30 days of the dose of study medication

          -  Pregnant females, breastfeeding female subjects and male subjects with partners
             currently pregnant

          -  Use of herbal supplements in the 28 days prior to the dose of study medication

          -  Blood donation (excluding plasma donation) of approximately 1 pint or more within 56
             days prior to study medication

          -  A positive urine drug screen for illicit drugs
A Study of Abemaciclib in Participants With Varying Degrees of Liver Impairment
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Intervention: Abemaciclib
Intervention description: Administered Orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study involves a single dose of a study drug called abemaciclib taken by mouth. The
      purpose of this study will be to measure how much study drug gets into the blood stream and
      how long the body takes to get rid of it when given to participants with mild, moderate, or
      severe liver impairment compared to healthy participants. In addition, the tolerability of
      the study drug will be evaluated.

      This study will last approximately 3 weeks for each participant, including check-in and
      follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participants must be of non-child-bearing potential

          -  Have a body mass index of 18 to 40 kilograms per square meter (kg/m²)

        Exclusion Criteria:

          -  No history of cardiovascular, renal, respiratory, gastrointestinal, endocrine or
             hematological disorders

          -  Have known allergies to abemaciclib, related compounds, or any components of the
             formulation

          -  No human immunodeficiency virus (HIV) infection or antibodies
A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain (0000-105)(COMPLETED)
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Naproxen; Placebo; Ultracet
Intervention description: Naproxen tablets 500 mg twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Twice daily on Day 2 and 500 mg once daily on Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period.; Placebo capsules twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Three times daily on Day 2, and 2 capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period.; Ultracet (tramadol/acetaminophen) 37.5/325 mg/mg capsules twice daily on Day 1, a first dose at t = 0 hrs, and a second dose at t = 12 hrs. Three times daily on Day 2, and two 37.5/325 mg capsules on the morning of Day 3. Walking tests will be performed on Days 1 and 3 of the treatment period.
Intervention MeSH terms: Naproxen
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      This study will evaluate a walking model of osteoarthritis for use in testing of new
      therapeutic agents. The primary hypothesis is that participants treated with Naproxen or
      Ultracet will have lower Pain Intensity (PI) than those treated with Placebo during
      self-paced walks on Day 3 of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has osteoarthritis of the knee and primary source of pain is knee

          -  Females must not be pregnant or nursing and must agree to use birth control throughout
             the study

          -  Is willing to limit alcohol and caffeine intake

          -  Is willing to abstain from smoking during study visits

          -  Must be able to walk on a treadmill at a pace of at least 1 mile/hour

        Exclusion Criteria:

          -  Has a medical/arthritic disease that would interfere with evaluation

          -  Is unable to take naproxen or Ultracet

          -  Has congestive heart failure or angina

          -  Has a history of stroke

          -  Has a history of uncontrolled high blood pressure

          -  Has a history of cancer

          -  Regularly uses a walker or cane
A Dose-escalation Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-573 in Subjects With Advanced Solid Tumors
Condition: Cancer
Intervention: MEDI-573
Intervention description: Administered at a dose determined by the subject's enrollment cohort as an IV infusion as part of a 21 day treatment cycle.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      Evaluate the safety and tolerability of MEDI-573 in adult subjects with advanced solid tumors
      refractory to standard therapy or for which no standard therapy exists.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed advanced solid tumor for which no curative or standard
             therapies exist.

          -  Karnofsky Performance Status ≥60.

          -  Adequate hematological function.

          -  Adequate organ function.

          -  Women of non-child-bearing potential (defined as being >1 year post-menopausal) or
             using effective contraception, e.g., use of oral contraceptives with an additional
             barrier method (since the investigational product may impair the effectiveness of oral
             contraceptives), double barrier methods (diaphragm with spermicidal gel or condoms
             with contraceptive foam), Depo-Provera, partner vasectomy, or total abstinence, from
             the time the informed consent is signed through 30 days after the last dose of
             MEDI-573. Male subjects with partners of child-bearing potential must be surgically
             sterile or use contraceptive method as described above from the time of the initiation
             of MEDI-573 through 30 days after the last dose of MEDI-573.

        Exclusion Criteria:

          -  No prior treatment within 4 weeks of study drug administration.

          -  No concurrent therapy for treatment of cancer.

          -  No uncontrolled diabetes.

          -  New York Heart Association Grade ≥ 2 congestive heart failure.

          -  History of myocardial infarction, unstable angina, transient ischemic attack or stroke
             within the previous 6 months prior to study entry.

          -  Documented brain metastasis.

          -  Pregnancy or lactation or plans to become pregnant while on study.

          -  Clinically significant abnormality on ECG.