bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma
Condition: Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous
Intervention: RP6530
Intervention description: Tablet starting at 200 mg
Intervention MeSH terms: Tenalisib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CTCL; PTCL; RP6530

Summary:

      The purpose of this study is to evaluate the safety, PK and efficacy of RP6530, a dual PI3K
      delta/gamma inhibitor in patients with relapsed and refractory T-cell Lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed T cell Non-Hodgkin Lymphoma (T-NHL)

          -  Refractory to or relapsed after at least 1 prior treatment line.

          -  ECOG performance status ≤2

          -  Patients must be ≥18 years of age

          -  Able to give a written informed consent.

        Exclusion Criteria:

          -  Any cancer therapy in the last 3 weeks or limited palliative radiation <2 weeks

          -  Patients with HBV, HCV or HIV infection

          -  Previous therapy with GS-1101 (CAL-101, Idelalisib), IPI-145 (Duvelisib), TGR-1202 or
             any drug that specifically inhibits PI3K/ mTOR (including temsirolimus, everolimus),
             AKT or BTK Inhibitor (including Ibrutinib) in last 6 months

          -  Patients on immunosuppressive therapy including systemic corticosteroids.

          -  Patients with known history of liver disorders.

          -  Patients with uncontrolled Diabetes Type I or Type II

          -  Any severe and/or uncontrolled medical conditions or other conditions that could
             affect their participation in the study.

          -  Women who are pregnant or lactating.
Drug-Drug Interaction Between Colchicine and Verapamil ER
Condition: Pharmacokinetics
Intervention: Colchicine; Verapamil HCl ER; Colchicine
Intervention description: A single dose of 0.6 mg colchicine administered alone at 8am on Day 1 after an overnight fast of at least 10 hours.; One 240 mg verapamil HCl ER tablet taken at 8am on Days 15-18 without regard to meals and along with colchicine at 8am on Day 19 after an overnight fast of at least 10 hours.; A single dose of 0.6 mg colchicine administered along with verapamil HCL ER at 8 am on Day 19 after an overnight fast of at least 10 hours.
Intervention MeSH terms: Colchicine; Verapamil
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp).
      Verapamil hydrochloride is a potent inhibitor of cytochrome P450 (CYP) 3A4 and P-gp. This
      study will evaluate the effect of multiple doses of extended-release verapamil hydrochloride
      (verapamil HCl ER) on the pharmacokinetic profile of a single 0.6 mg dose of colchicine. A
      secondary objective is to evaluate the safety and tolerability of this regimen in healthy
      volunteers. All study subjects will be monitored for adverse events throughout the study
      period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-45 years of age, non-smoking and non-pregnant (post-menopausal,
             surgically sterile or using effective contraceptive measures) with a body mass index
             (BMI) greater than or equal to 18 and less than or equal to 32, inclusive.

        Exclusion Criteria:

          -  Recent participation (within 28 days) in other research studies

          -  Recent significant blood donation or plasma donation

          -  Pregnant or lactating

          -  Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HbsAg), or hepatitis C virus (HCV)

          -  Recent (2-year) history or evidence of alcoholism or drug abuse

          -  History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or
             biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic,
             dermatologic, neurologic, or psychiatric disease

          -  Subjects who have used any drugs or substances known to inhibit or induce cytochrome
             (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose
             and throughout the study

          -  Drug allergies to colchicine or verapamil
A Study of Ixekizumab in Healthy Participants
Condition: Healthy
Intervention: Ixekizumab
Intervention description: Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare three different formulations of ixekizumab. One
      formulation (Reference) has been approved by the Food and Drug Administration (FDA) and two
      formulations (Test 1 and Test 2) have not been approved. This study will compare how much of
      each of the three formulations get into the blood stream. Information about any side effects
      that may occur will also be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male participant or female participant who agree to not become pregnant

          -  Are male participant or female participants with chronic stable medical problems, that
             in the investigator's opinion will not place the subject at increased risk by
             participating in the study

        Exclusion Criteria:

          -  Have a significant history of, or current, cardiovascular, respiratory, hepatic,
             renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of
             the investigator poses an unacceptable risk to the participant if participating in the
             study

          -  Are allergic or hypersensitive to the study medicine

          -  Had a vaccination with a live vaccine within 12 months prior to the first check-in or
             intend to get a vaccine for tuberculosis within 12 months of completing treatment on
             this study

          -  Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other
             serious infection

          -  Show evidence of active or latent tuberculosis (TB)

          -  Presence of significant neuropsychiatric disorder or a recent history of depression

          -  Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion
             of the investigator would pose an unacceptable risk to the participant, if
             participating in the study
A Study of LY3079514 in Healthy Participants
Condition: Healthy Volunteers
Intervention: LY3079514; LY3079514; Placebo; Placebo
Intervention description: Administered SC; Administered IV; Administered SC; Administered IV
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to evaluate the safety and how well the body will handle a
      single dose of study drug, LY3079514. This study will last about 12 weeks for each
      participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy participants as determined by medical history and physical examination

          -  To qualify as Japanese for the purpose of this study, the Japanese participant must be
             first-generation Japanese

          -  Have a body mass index (BMI) between 18.5 and 32.0 kilograms per square meter (kg/m^2)
             and have a minimum body weight of 50 kilograms (kg), inclusive at screening

          -  Have clinical laboratory test results within normal reference range for the population
             or investigator site, or results with acceptable deviations that are judged to be not
             clinically significant by the investigator

        Exclusion Criteria:

          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
             investigator, increases the risks associated with participating in the study

          -  Have an abnormal blood pressure that is considered to be clinically significant, as
             determined by the investigator

          -  Have a history or presence of cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders capable of
             significantly altering the absorption, metabolism, or elimination of drugs; of
             constituting a risk when taking the study medication; or of interfering with the
             interpretation of data

          -  Have known or ongoing psychiatric disorders

          -  Regularly use known drugs of abuse and/or show positive findings on urinary drug
             screening

          -  Show evidence of human immunodeficiency virus (HIV) infection and/or positive human
             HIV antibodies

          -  Show evidence of hepatitis C and/or positive hepatitis C antibody

          -  Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Transition From Alendronate to Romosozumab (AMG 785)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Romosozumab
Intervention description: Administered by subcutaneous injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Female
Minimum age: 55 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: AMG 785, bone mineral density, alendronate

Summary:

      The purpose of this study is to estimate the percent change from baseline in lumbar spine
      bone mineral density (BMD) following multiple-dose administrations of romosozumab in
      postmenopausal women with low BMD previously treated with alendronate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women, defined as no vaginal bleeding or spotting for ≥ 12 months

          -  Low bone mineral density at screening [defined by a bone mineral density (BMD) T-score
             ≤ -2.0 and ≥ -4.0 at the lumbar spine (L1 to L4; or BMD T-score of evaluable
             vertebrae), total hip, or femoral neck]

          -  Currently taking alendronate (70 mg weekly or equivalent) exclusively for ≥ 1 year
             with verbal agreement that the subject has taken ≥ 80% of their doses with good
             tolerance

        Exclusion Criteria:

          -  History of vertebral fracture, or fragility fracture of the wrist, humerus, hip or
             pelvis after age 50; or recent bone fracture within 6 months prior to screening

          -  History of metabolic or bone disease such as Paget's disease, rheumatoid arthritis,
             osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis,
             Cushing's disease, hyperprolactinemia, and malabsorption syndrome

          -  Vitamin D deficiency (defined as 25-OH-VitD levels < 20 ng/mL)
An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: BENEFIX
Intervention description: Single dose of 50 IU/kg of BeneFIX by intravenous infusion within 10 minutes.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Male
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      The sample size of 12 male Chinese subjects are based on the CFDA requirement for a China PK
      study and to support the registration in China.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male Chinese subjects 6 years or older (weight ≥20kg) with moderate to severe
             hemophilia B (Factor IX activity ≤2%).

          -  Subjects should not have received an infusion of any Factor IX products for at least 4
             days before the administration of BeneFIX on Day 1.

          -  Subjects must be in a non-bleeding state before the administration of BeneFIX on Day
             1.

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal
             allergies at time of dosing) disease or clinical findings at Screening.

          -  Diagnosed with any other bleeding disorder in addition to hemophilia B.

          -  Current FIX inhibitor or history of FIX inhibitor (defined as > Upper Limit of Normal
             (ULN) of the reporting lab).
Interactive Cholesterol Advisory Tool
Condition: Low Risk (0-10% Chance) of Developing Cardiovascular Disease Within 10 Years Based on Risk Factors; Moderate Risk (10-20% Chance) of Developing Cardiovascular (Heart) Disease Within 10 Years Based on Risk Factors
MeSH terms: Cardiovascular Diseases
Intervention: Interactive Cholesterol Advisory Tool; Study physician visits
Intervention description: using the virtual clinician computer program for cholesterol information and education.; In-person individual visits with a study physician to give information on cholesterol
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cardiovascular disease; cholesterol

Summary:

      The purpose of this study is to show that we can effectively deliver health information and
      education, online, via computer regarding cholesterol. This computer program is called the
      Interactive Cholesterol Advisory Tool (ICAT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fluency in English,

          -  Willing to come in for 1-5 visits,

          -  Low and moderate CVD risk.

          -  Having access to a computer with internet connection

        Exclusion Criteria:

          -  CVD diagnosis or CVD equivalent,

          -  Psychosis, terminal illness,

          -  Pregnancy,

          -  Current statin use if assigned to the low risk group

          -  Liver disease,

          -  Peripheral Vascular Disease,

          -  Diabetes Mellitus,

          -  Abdominal Aortic Aneurism,

          -  Cerebral Vascular Disease

          -  Triglyceride level above 500 mg/dl

          -  Uncorrected hypothyroidism
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects
Condition: Healthy
Intervention: SB4; EU sourced Enbrel; US sourced Enbrel
Intervention description: SC administration; SC administration; SC administration
Intervention MeSH terms: Etanercept
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 138.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics

Summary:

      The purpose of this study is to compare the pharmacokinetics, safety and immunogenicity of
      SB4 and Enbrel (EU sourced Enbrel and US sourced Enbrel) in healthy male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects

          -  Have a body weight between 60 and 94.9 kg and a body mass index between 20.0 and 29.9
             kg/m², inclusive.

        Exclusion Criteria:

          -  history and/or current presence of clinical significant atopic allergy,
             hypersensitivity or allergic reactions, also including known or suspected clinically
             relevant drug hypersensitivity to any components of the test and reference IP
             formulation or comparable drugs.

          -  active or latent Tuberculosis or who have a history of TB.

          -  history of invasive systemic fungal infections or other opportunistic infections

          -  systemic or local infection, a known risk for developing sepsis and/or known active
             inflammatory process

          -  serious infection associated with hospitalisation and/or which required intravenous
             antibiotics

          -  history of and/or current cardiac disease

          -  have received live vaccine(s) within 30 days prior to Screening or who will require
             live vaccine(s) between Screening and the final study visit.

          -  Intake medication with a half-life > 24 h within 1 month or 10 half-lives of the
             medication prior to the first administration of IP.
A Study of LY3202626 in Healthy Participants and Participants With Alzheimer's Disease
Condition: Healthy Volunteers; Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: LY3202626; Placebo (Part A, B, C); Itraconazole
Intervention description: administered orally; administered orally; administered orally
Intervention MeSH terms: Itraconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 94.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study involves single and multiple doses of LY3202626 and will evaluate the effects of
      LY3202626 on the body. There will be 4 parts to this study. In Parts A and B, single
      increasing doses of LY3202626 will be given in capsule form. Part A will also include
      itraconazole given orally as a solution. Part A will last approximately 8-12 weeks. Part B
      will last approximately 5-6 weeks. In Parts C and D, participants will be dosed multiple days
      with the study drug. Part C will last approximately 11-14 weeks. Part D will last
      approximately 11-14 weeks and participants must have Alzheimer's Disease. Participants may
      only enroll in one part.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For Parts A, B, and C, are overtly healthy males or females (nonchildbearing
             potential), as determined by medical history and physical examination

          -  Have a body mass index (BMI) of 18 to 32 kilograms per square meter (kg/m^2)

          -  For Part D, present with Mild Cognitive Impairment (MCI) due to Alzheimer's Disease
             (AD) or mild to moderate AD

          -  Have venous access sufficient to allow for blood sampling

          -  Are reliable and willing to make themselves available for the duration of the study
             and are willing to follow study procedures and research unit policies

        Exclusion Criteria:

          -  Taking over-the-counter or prescription medication with the exception of vitamins or
             minerals

          -  Smoke more than 10 cigarettes per day

          -  Are unwilling or unable to refrain from eating any food or drinking any beverage
             containing grapefruit or grapefruit juice for at least 2 weeks prior to first dose
             until completion of the study
A Study of Pegylated Interferon Alfa-2b (MK-4031) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (MK-4031-370)
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: PegIFN alfa-2b
Intervention MeSH terms: Peginterferon alfa-2b
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a study to evaluate the safety and tolerability of peginterferon alfa-2b (PegIFN
      alfa-2b) as adjuvant treatment in Japanese participants with malignant melanoma after
      definitive surgical resection including complete lymphadenectomy. Participants on this study
      will initially receive PegIFN alfa-2b for 8 weeks (Induction Phase) and then may continue to
      receive PegIFN alfa-2b (Maintenance Phase) as long as they are experiencing clinical benefit
      (Up to 252 weeks). The primary hypothesis is that peginterferon alfa-2b administered on a
      weekly basis is safe and tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage II or III melanoma

          -  Primary melanoma completely excised

          -  Full lymphadenectomy within 84 days prior to initiation of study treatment

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

        Exclusion Criteria:

          -  Ocular melanoma or melanoma of the mucous membranes

          -  Evidence of distant or non-regional lymph node metastases

          -  In-transit melanoma

          -  Previously treated with interferon alpha/beta, chemotherapy, hormonal therapy,
             radiotherapy or immunotherapy/vaccine for melanoma
Phase I/II, Open-label, Multi-center, Two Part Dose-escalation, Safety, Pharmacokinetics (PK) and Efficacy Study of AZD4877 in Patients With Acute Myelogenous Leukemia (AML)
Condition: Acute Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: AZD4877
Intervention description: intravenous infusion administered on days 1, 2 and 3
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase I; Phase II; acute myelogenous leukemia; AML; cancer

Summary:

      The primary purpose of this study is to find out what the maximum tolerated dose is for an
      experimental drug called AZD4877 based on the side effects experienced by patients that
      receive AZD4877 on a daily times 3 schedule in acute myelogenous leukemia (AML).

      For enrollment information see the Central Contact information below
    

Eligibility criteria:

        Inclusion Criteria:

          -  Part A: Relapsed or refractory leukemia for which no standard therapies are
             anticipated to result in a durable remission

          -  Part B: AML who have had no more than two prior relapses or failed to achieve
             remission after at least one induction treatment.

          -  Patients with prior allogeneic transplants who remain clinically stable for ≥2 weeks
             or more off immunosuppressive therapy

        Exclusion Criteria:

          -  Promyelocytic acute myelogenous leukemia

          -  Prior allogeneic transplant requiring immunosuppressive therapy or treating physician
             does not consider patient to be a candidate for allogeneic transplantation.

          -  Liver injury