bioihbjkbjnl/mcl2 huggingface dataset:
Dose Titration Investigation of the Pharmacokinetics of Testosterone Transdermal Systems in Hypogonadal Men
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testerone Transdermal System
Intervention description: Transdermal testosterone applied daily for 4 weeks
Intervention MeSH terms: Testosterone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypogonadism; Testosterone; Hormone replacement therapy

Summary:

      The study will evaluate the pharmacokinetics of testosterone transdermal systems at
      steady-state in hypogonadal men.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males in good general health, 18 years of age or older.

          -  Have a previously documented testosterone deficiency.

          -  Willing and able to comply with the requirements of the protocol.

        Exclusion Criteria:

          -  Have a history of intolerance to Androderm or other testosterone products.

          -  Prostate specific antigen (PSA) level ≥ 4.0 ng/mL

          -  Prostate cancer or severe benign prostatic hypertrophy (BPH)

          -  Have significant abnormalities in the physical examination at screening.

          -  Have current dermatological disease, skin damage or blemishes.

          -  Have participated in an investigational drug study within 30 days prior to screening.
Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma and Various Levels of Renal Function
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Lenalidomide; Dexamethasone; Dexamethasone; Dexamethasone; Elotuzumab (BMS-901608; HuLuc63)
Intervention description: Capsules, Oral, 15 mg, One capsule every 48 hours through Days 1-21 (Repeat every 28 days until subject meets criteria for discontinuation of study drug; Tablets, Oral, 28 mg weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 &15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug; Tablets, Oral, 40 mg, weekly, on days 8, 15 & 22 (cycle 1); days 8 &22 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug; Solution, Intravenous, 8 mg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 &15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug; Solution, Intravenous, 10 mg/kg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 &15 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lenalidomide; Elotuzumab; BB 1101
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the concentration of Elotuzumab in Myeloma patients
      with very low kidney function including patients on dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with Multiple Myeloma (MM) and renal function fitting one of three
             categories:

               1. Severe renal impairment: estimated creatinine clearance (CrCl) <30 ml/min, but
                  not requiring dialysis

               2. End-stage renal disease: requiring hemodialysis

               3. Normal renal function: estimated CrCl ≥90 ml/min

          -  Documented evidence of symptomatic MM, either newly diagnosed or relapsed/refractory

          -  Prior Lenalidomide exposure is permitted only if the subject did not discontinue
             Lenalidomide due to a Grade ≥3 related Adverse Event (AE)

        Exclusion Criteria:

          -  Monoclonal Gammopathy of Undetermined Significance (MGUS), Waldenstrom's
             macroglobulinemia, or smoldering myeloma

          -  Active plasma cell leukemia

          -  All adverse events of any prior chemotherapy, surgery, or radiotherapy not resolved

          -  POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly,
             endocrinopathy, monoclonal protein, and skin changes)

          -  Acute renal failure
Anidulafungin PK in Infants and Toddlers
Condition: Invasive Fungal Infections
MeSH terms: Mycoses; Invasive Fungal Infections
Intervention: Anidulafungin
Intervention description: Intravenous form. Loading Dose: 3 mg/kg/dose. Maintenance dose: 1.5 mg/kg/dose. Treatment duration: 5 days total.
Intervention MeSH terms: Anidulafungin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 48 Hours
Maximum age: 24 Months
Healthy volunteers: No

Summary:

      This is a prospective, open-label, single center, pharmacokinetic study of anidulafungin in
      infants and toddlers less than 24 months of age with suspected serious infection. There will
      be up to 24 subjects enrolled; each will receive anidulafungin. Patients will receive
      anidulafungin 3 mg/kg loading dose on day 1 of study and will receive 1.5 mg/kg every 24
      hours on study days 2-5.Plasma pharmacokinetics will be evaluated using a limited sampling
      scheme. We hypothesize that the PK parameters of anidulafungin will not differ from those
      observed in older children and adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age < 24 months at the time of enrollment

          -  Patient must have sufficient venous access to permit administration of study
             medication

          -  Infant or toddler suspected to have a serious infection and from whom a blood culture
             has been obtained with 48 hours of study entry

          -  Availability and willingness of the parent/legally authorized representative to
             provide written informed consent.

        Exclusion Criteria:

          -  Patients with a history of anaphylaxis attributed to an echinocandin

          -  Any other concomitant condition, which in the opinion of the investigator would
             preclude a patient's participation in the study

          -  Previous participation in this study

          -  Previous exposure to an echinocandin in the month prior to study.
Asian Phase I Study Of PF-03446962
Condition: Neoplasms
Intervention: PF-03446962
Intervention description: PF 03446962 given by a 1 hour IV infusion. Each patient will initially receive the first dose on Cycle 1 Day 1 with a 28 day observation period. Cycle 2 will start on Day 29. The dosing interval will be 14 days for Cycle 2 and subsequent cycles.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatocellular Carcinoma; Advanced/Metastatic solid tumors

Summary:

      This is an Asian Phase 1, multi center, open label, single arm study of PF 03446962 with dose
      escalation and designed to define the Maximum Tolerated Dose [MTD] and the Recommended Phase
      2 Dose [RP2D].
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of stomach cancer

          -  advanced/metastasis solid tumor refractory or intolerant to established therapy

          -  adequate blood chemistry, blood counts and kidney/liver function

          -  willing to participate to study requirements and sign an informed consent document

        Exclusion Criteria:

          -  Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of
             first dose of study medication

          -  excessive toxicities related to prior therapies

          -  pregnant or breastfeeding patients
AZD8848 Single Ascending Dose Study
Condition: Healthy
Intervention: AZD8848; Placebo
Intervention description: Single dose, oral inhalation (nebuliser solution); Single dose, oral inhalation (nebuliser solution)
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; tolerability; healthy; pharmacokinetic; pharmacodynamic; inhaled

Summary:

      This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics
      of single ascending doses of AZD8848 in healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men or women aged 18 to 45 years (inclusive) with suitable veins for
             cannulation or repeated venipuncture.

          -  Women can be of childbearing potential and must have been stable on a highly effective
             contraceptive method for at least 3 months prior to Visit 1 (screening) and be willing
             to continue on the chosen contraceptive method

          -  Male subjects should be willing to use a condom (with spermicide) to prevent pregnancy
             and drug exposure of a female partner and refrain from donating sperm or fathering a
             child from the day of the investigational product administration until 3 months

          -  Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no
             more than 100 kg

          -  Ability to produce sputum of good enough quality for assessment of biomarkers

        Exclusion Criteria:

          -  Abnormal vital signs, after 10 minutes supine rest, defined as any of the following
             (SBP > 140 mmHg, Diastolic blood pressure (DBP) > 90 mmHg, Heart rate < 40 or > 85
             beats per minute)

          -  Prolonged QTcF > 450 ms or shortened QTcF < 340 ms or family history of long QT
             syndrome

          -  History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as
             judged by the Investigator or history of hypersensitivity to drugs with a similar
             chemical structure or class as AZD8848

          -  History of additional risk factors for Torsade de pointes (e.g., heart failure,
             hypokalaemia, family history of Long QT syndrome, or sudden death)

          -  History of asthma or allergic rhinitis
A Study of How Insulin Peglispro (LY2605541) and Insulin Glargine Affect the Breakdown of Fat and Sugar in Type 1 Diabetics
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY2605541; Insulin Glargine
Intervention description: Administered SQ; Administered SQ
Intervention MeSH terms: Insulin Glargine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a two-period study of participants with type 1 diabetes mellitus (T1DM). In each
      period, participants will receive once daily injections of stable dose LY2605541 or insulin
      glargine for 28 to 35 days followed by procedures to look at how the body uses or stores fats
      and sugars. Participants will continue to use meal time insulin throughout the study. Healthy
      participants will also enroll in the study. They will not receive any study medication.
    

Eligibility criteria:

        Inclusion Criteria:

        Type 1 Diabetics:

        - T1DM for more than 1 year with Hemoglobin A1c (HbA1c) of less than 9.5%

        All Participants:

          -  Otherwise fit and healthy

          -  Non smoker

        Exclusion Criteria:

        Type 1 Diabetics:

          -  Taking medication or supplements other than insulin to control diabetes

          -  Suffered a hypoglycemic event in the last 12 months that required hospitalization or
             have poor awareness of hypoglycemia

        All Participants:

        - Taking fibrates, thyroid replacement therapy, testosterone, beta blockers or systemic
        corticosteroids
Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
Condition: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases
Intervention: Placebo; PF-04856883; PF-04856883; PF-04856883; Placebo; PF-04856883; PF-04856883; PF-04856883; Placebo; PF-04856883; PF-04856883; PF-04856883; PF-04856883
Intervention description: Single subcutaneous injection of placebo; Single subcutaneous injection of PF-04856883; Single subcutaneous injection of PF-04856883; Single subcutaneous injection of PF-04856883; Single subcutaneous injection of placebo; Single subcutaneous injection of PF-04856883; Single subcutaneous injection of PF-04856883; Single subcutaneous injection of PF-04856883; Multiple weekly subcutaneous injections of placebo for 3 weeks; Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks; Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks; Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks; Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 84.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Phase 1; Type 2 Diabetes; CVX-096

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of PF-04856883
      (CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of Type 2 diabetes and currently being treated with high dose metformin

          -  BMI between 22.0 and 40.0 kg/m2

          -  HbA1c between 7.0-10.0%

          -  Fasting C-peptide >1.21 ng/mL

        Exclusion Criteria:

          -  History of clinically significant chronic conditions other than Type 2 diabetes not
             well controlled by either diet or medications

          -  Treatment with anti-diabetic therapies other than metformin

          -  History of allergic or anaphylactic reaction to any therapeutic or diagnostic
             monoclonal antibody

          -  Males or women of childbearing potential
A Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)(0683-066)
Condition: Neoplasms
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: MK0683, vorinostat
Intervention description: vorinostat 300 mg or 400 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle.
Intervention MeSH terms: Vorinostat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Non-Small Cell Lung Cancer (NSCLC)

Summary:

      The clinical study will evaluate safety, tolerability and Pharmacokinetics of MK0683 in
      combination with carboplatin and paclitaxel in chemotherapy-naive NSCLC patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chemotherapy-naive patients who are histologically or cytologically diagnosed NSCLC
             with stage IIIB (not applicable of radical thoracic radiation) or stage IV

          -  Patients with normal organ function and bone marrow function

        Exclusion Criteria:

          -  Given radical thoracic radiation for NSCLC or radiation for other than original lesion
             within 3 weeks

          -  Any peripheral neuropathy above grade 2

          -  Any ascites, pleural effusion or pericardiac effusion which requires treatment

          -  Any uncontrolled concomitant illness

          -  Pregnant or breast-feeding
A Study of V950 in People With Alzheimer Disease (V950-001 AM7)
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: V950; ISCOMATRIX™; Placebo to V950
Intervention description: V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment.; ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment.
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 86.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the safety, tolerability and the immune response to an
      investigational vaccine, V950, with or without ISCOMATRIX™ (IMX).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has mild to moderate Alzheimer Disease

          -  Women cannot be able to get pregnant

          -  Patient has a reliable caregiver, who will attend all visits and answer questions
             about the patient

        Exclusion Criteria:

          -  Patient lives in a nursing home or facility

          -  Patient has another neurological or neurodegenerative disorder

          -  Patient has a history of stroke

          -  Patient uses illicit drugs or has a history of drug/alcohol abuse

          -  Patient has received blood or blood derived products within 6 months
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
Condition: Covid19
MeSH terms: COVID-19
Intervention: BGB DXP593; Placebo
Intervention description: Administered intravenously (IV) as specified in the treatment arm; Placebo to match BGB-DXP593
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary purpose of this study is to investigate the safety and tolerability of BGB-DXP593
      administered intravenously as a single dose in healthy participants
    

Eligibility criteria:

        Key Inclusion Criteria :

          1. Participants are in good general health as determined by the investigator or medically
             qualified designee, based on a medical evaluation including medical history, physical
             examination, laboratory tests and cardiac monitoring

          2. Body weight ≥ 50 kg and body mass index (BMI) within the range 18 to 32 kg/m2
             (inclusive) Note: BMI = weight [kg] / (height [m])

          3. Negative serum IgG to the SARS-CoV-2

          4. Negative for COVID-19 based on the nasopharyngeal or oropharyngeal swab with the
             method of real-time reverse transcription-polymerase chain reaction (rRT-PCR)

        Key Exclusion Criteria:

          1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal,
             endocrinological, hematological, or neurological disorders capable of significantly
             altering the absorption, metabolism, or elimination of drugs, constituting a risk to
             the participant when taking the study drug; or interfering with the interpretation of
             data

          2. Any history of a severe allergic reaction prior to enrollment that has a reasonable
             risk of recurrence during the study

          3. Have a medical history of SARS infection

          4. Any acute fever disease or infections

          5. Any chronic or clinically significant medical condition that, in the opinion of the
             investigator, would jeopardize the safety or rights of the participant, including but
             not limited to: diabetes mellitus type I, chronic hepatitis; or clinically significant
             forms of: drug or alcohol abuse, asthma (except for childhood asthma), autoimmune
             disease, psychiatric disorders, or heart disease

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients
Condition: Liver Transplant; Liver Transplantation
Intervention: Immunosuppression Withdrawal
Intervention description: Gradual withdrawal of immunosuppressive medication. With high dose, daily dose reduction by 25% for 8 weeks. With low dose, daily dose reduction by 25% for 4 weeks.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Recipients of parental living-donor liver allografts will undergo gradual withdrawal as tolerated of immunosuppression with the goal of complete withdrawal.
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 4 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: immunosuppression withdrawal (IS); anti-rejection drugs; tolerance; allograft function

Summary:

      Antirejection medicines, also known as immunosuppressive drugs, are prescribed to organ
      transplant recipients to prevent their bodies from rejecting the new organ. Long-term use of
      these drugs places transplant recipients at higher risk of serious infections and certain
      types of cancer. The purpose of this study is to determine whether immunosuppressive drugs
      can be safely withdrawn over a minimum of 9 months from children who received liver
      transplants at least 4 years ago.
    

Eligibility criteria:

        Inclusion Criteria for Liver Recipients:

          -  Received liver from living parent donor

          -  Received transplant at least 4 years prior to study entry

          -  Less than 18 years of age at time of transplant

          -  Parent or guardian willing to provide informed consent

        Inclusion Criteria for Liver Donors:

          -  Willing to participate in this study

        Exclusion Criteria for Liver Recipients:

          -  Underwent transplant because of liver failure related to autoimmune disease

          -  Underwent transplant of a second organ simultaneously with or after liver transplant
             OR liver retransplantation

          -  Receiving immunosuppression with more than one drug

          -  50% increase in dose of current immunosuppressive drug

          -  HIV infection

          -  Hepatitis B or C virus infection

          -  Pregnancy or breastfeeding