bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Compare Two Different Formulations of Lasmiditan in Healthy Participants
Condition: Healthy
Intervention: Lasmiditan
Intervention description: Administered orally.
Intervention MeSH terms: Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to compare the amount of lasmiditan that gets into the
      blood stream and how long it takes the body to get rid of it, when given as a
      oral-disintegrating (OD) tablet compared to immediate-release (IR) tablet formulation. The
      information about any adverse effects experienced will be collected and the tolerability of
      lasmiditan when administered as OD tablet will also be evaluated.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the total duration of the clinical trial will be about 5 weeks, including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy as determined by medical evaluation.

          -  Body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²).

        Exclusion Criteria:

          -  Have known allergies to lasmiditan, related compounds, or any components of the
             formulation of lasmiditan, or a history of significant atopy.

          -  Have an abnormal blood pressure and/or pulse rate, as determined by the investigator.

          -  Have clinically significant abnormalities on ECG, as determined by investigator.

          -  Have a history or presence of cardiovascular, respiratory, 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 interventions; or of interfering with the interpretation of data.

          -  Have used or are intending to use over-the-counter or prescription medication,
             including dietary supplements, within 14 days prior to dosing and until study
             discharge (apart from occasional acetaminophen, hormonal contraception, or
             hormone-replacement therapy).
Speech Recognition Training in Children With Hearing Loss
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness
Intervention: clEAR auditory training
Intervention description: Children play auditory brain training computer games
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Within subjects A1 - A2 - B1 - B2 design
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 8 Years
Maximum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Auditory training; Children with hearing loss

Summary:

      clEAR's auditory brain training has been shown to be effective in improving childrens'
      abilities to recognize the speech of generic talkers in a laboratory setting. In the proposed
      research, the researchers will build upon these results and assess the extent to which
      auditory brain training delivered via the web enhances children's abilities to recognize the
      speech of a potential classroom teacher and diminishes their communication challenges that
      are associated with significant hearing loss. First, investigators will conduct focus groups
      with children who have undergone training with the research version of clEAR's pediatric
      games, then they will recode the games from LabView to Java Script, making changes in the
      games in response to the focus group comments, and finally, they will collect data from 20
      children to assess whether web-based auditory brain training improves their abilities to
      recognize the speech of their (hypothetical) upcoming school year's classroom teacher.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children with moderate to severe hearing loss.

        Exclusion Criteria:

          -  Must be native English speakers
A Study of LY900014 in Elderly and Younger Adult Participants With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin Lispro
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in elderly and
      younger adults with type 1 diabetes mellitus.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the total duration of the clinical trial will be between 3 to 8 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are male or female participants with Type 1 Diabetes Mellitus (T1DM)

          -  Have a body mass index (BMI) of 18.5 to 30.0 kilogram per meter square (kg/m²)

          -  Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)

          -  Have had no episodes of severe hypoglycaemia in the last 6 months

        Exclusion Criteria:

          -  Have a history or current cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine (apart from T1DM), hematological, or neurological
             disorders capable of significantly altering the absorption, metabolism, or elimination
             of drugs; of constituting a risk when taking the investigational product; or of
             interfering with the interpretation of data

          -  Have a history of renal impairment

          -  Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg
             vein thrombosis in first-degree relatives

          -  Have proliferative retinopathy or maculopathy and/or severe neuropathy
N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19)
Condition: Coronavirus; Covid19
MeSH terms: COVID-19; Coronavirus Infections
Intervention: N-acetyl glucosamine (NAG); Control
Intervention description: Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.; Patients do not receive treatment with N-Acetylglucosamine. They may receive other treatments at the discretion of the treating physician, as with the treatment group.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: N-acetyl glucosamine

Summary:

      This study examines the efficacy of N-acetylglucosamine (NAG) in treating patients with novel
      coronavirus (COVID-19) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥18 years old

          -  Treated with N-acetyl glucosamine (NAG) as first-line treatment

          -  Present with coronavirus disease 2019 (COVID-19) symptoms (including but not limited
             to fever, cough, shortness of breath, sore throat, nasal congestion, malaise,
             headache, muscle pain, loss of taste and/or smell, diarrhea, and vomiting)

          -  Clinically diagnosed with COVID-19 by reverse transcription polymerase chain reaction
             (RT-PCR)

          -  No intubation prior to hospitalization and enrollment in the current study.

        Exclusion Criteria:

          -  <18 years old upon admission

          -  Allergy to NAG

          -  Allergy to shellfish

          -  Currently taking warfarin

          -  Currently pregnant or lactating
Clearance of 25-hydroxyvitamin D3 During Vitamin D3 Supplementation
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: D6-25-hydroxyvitamin D3
Intervention description: Intravenous administration of a deuterium-labeled 25(OH)D3 to evaluate the metabolic clearance of 25(OH)D3
Intervention MeSH terms: Hydroxycholecalciferols; Calcifediol
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic kidney disease; vitamin d catabolism

Summary:

      The goal of this study is to determine how 25(OH)D3 clearance is affected by vitamin D3
      supplementation using a gold standard pharmacokinetic approach.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successful prior completion of related protocol CLEAR (NCT02937350) or CLEAR-CF
             (NCT03104855)

          -  Age ≥ 18 years

          -  Self-reported race Caucasian, African American, or African

        Exclusion Criteria:

          -  Primary hyperparathyroidism

          -  Gastric bypass

          -  Tuberculosis or sarcoidosis

          -  Current pregnancy

          -  Child-Pugh Class B or C cirrhosis (i.e. cirrhosis with ascites, hepatic
             encephalopathy, bilirubin >=2 mg/dL, serum albumin <=3.5 g/dL, or PT >= 4 seconds)

          -  History of kidney transplantation (unless failed transplant now treated with
             hemodialysis)

          -  Use of 1,25(OH)2D3 or an analogue, calcimimetics, or medications known to induce
             CYP24A1 within 4 weeks (wash-out allowed)

          -  Serum calcium > 10.1 mg/dL

          -  Hemoglobin < 10 g/dL
A Study to Test the Safety and Antibody Response of V212 in Healthy Adults (V212-004)(COMPLETED)
Condition: Herpes Zoster
MeSH terms: Herpes Zoster
Intervention: Comparator: V212; Comparator: Placebo
Intervention description: 0.65 mL subcutaneous injection of heat-treated Varicella zoster virus (VZV) vaccine or alternative inactivation method VZV vaccine A, B, C; 4-dose regimen administered ~30 days apart; Placebo; 4-dose regimen administered ~30 days apart.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 290.0
Sex: All
Minimum age: 50 Years
Maximum age: 59 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Herpes Zoster (Shingles)

Summary:

      The purpose of this study was to assess the safety and tolerability of gamma-irradiated
      varicella-zoster virus (VZV) vaccine A (Part 1) and gamma-irradiated VZV vaccine B and C
      (Part 2) and to determine if they were immunogenic when administered to healthy individuals,
      as measured by VZV-specific antibody responses by glycoprotein enzyme-linked immunosorbent
      assay (gpELISA). The primary hypothesis was that gamma-irradiated VZV vaccine A (Part 1) and
      gamma-irradiated VZV vaccine B and C (Part 2) would elicit an acceptable VZV-specific immune
      response. The secondary hypothesis for Part 1 of the study was that heat-treated VZV vaccine
      would elicit an acceptable VZV-specific immune response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be 50 to 59 years of age

          -  No fever on vaccination days

          -  Must have had chickenpox or lived in an area where the chickenpox virus is prevalent
             for 30 or more years

          -  Females of child-bearing potential must use acceptable forms of birth control

        Exclusion Criteria:

          -  Prior history of shingles

          -  Prior receipt of any chickenpox or shingles vaccine

          -  Pregnant or breastfeeding

          -  Received or expect to receive a live virus vaccine (such as measles, mumps, rubella)
             from 4 weeks before the first visit through the last visit

          -  Received or expect to receive an inactivated vaccine (such as tetanus or pneumonia)
             from 7 days before the first visit through the last visit

          -  Received immunoglobulin or blood products

          -  Receiving treatment that may weaken the immune system

          -  Have an immune system disorder
Study of Tirzepatide in Healthy Participants
Condition: Healthy
Intervention: 14C Tirzepatide
Intervention description: Administered SC.
Intervention MeSH terms: Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 30 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to look at how much tirzepatide gets into the bloodstream and
      how long the body takes to get rid of it. This study will involve a single dose of 14C
      radiolabelled tirzepatide. This means that a radioactive tracer substance, C14, will be
      incorporated into the study drug to investigate the study drug and its breakdown products and
      to find out how much of these pass from blood into urine, feces and expired air.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the total duration of the clinical trial will be approximately 15 weeks, including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy males as determined by medical history, physical examination, and
             other screening procedures

          -  Have a body mass index (BMI) between 18.0 to 32.0 kilograms per meter squared (kg/m²),
             inclusive at screening

          -  Are willing to be available for the full duration of the study

        Exclusion Criteria:

          -  Have known allergies to tirzepatide or related compounds

          -  Have a medical condition or medical history that makes participation in the study
             unsafe or which may interfere in the interpretation of the results of the study

          -  Have had exposure to significant radiation within 12 months prior to dosing (for
             example, multiple x-ray or computed tomography [CT] scans, barium meal, being employed
             in a job requiring radiation exposure monitoring)

          -  Have participated in any clinical trial involving a radiolabeled substance within the
             past 12 months
Safety Study With the Antibody, cG250, and Isotope, 124-Iodine, to Diagnose Patients With Renal Masses.
Condition: Cancer of Kidney; Kidney Cancer; Renal Cancer; Neoplasms, Kidney; Renal Neoplasms; Renal Cell Carcinoma (RCC); Clear Cell Renal Cell Carcinoma
MeSH terms: Carcinoma; Neoplasms; Carcinoma, Renal Cell; Kidney Neoplasms
Intervention: 124-Iodine-cG250 (124I-cG250)
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney Cancer; Renal Cancer; Neoplasms, Kidney; cG250; antibody; Iodine 124

Summary:

      The purpose of this study is to see if an antibody (cG250) attached to a radioactive
      substance (Iodine-124) safely detects clear cell renal cancer in patients with kidney tumors
      scheduled for surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Presence of a renal mass.

          2. Scheduled for surgical resection of renal mass.

          3. Expected survival of at least 3 months.

          4. Karnofsky performance scale ≥70.

          5. The following laboratory results should be within the following limits within the last
             4 weeks prior to study day 1:

               -  Absolute neutrophil count (ANC) ≥ 1.5 x 10E9/L

               -  Platelet count ≥ 100 x 10E9/L

               -  Serum bilirubin ≤ 2.0 mg/dL

               -  Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN)

               -  Alanine aminotransferase (ALT) ≤ 2.5 x ULN

               -  Serum creatinine ≤ 2.0 mg/dL

          6. Pregnancy Test to be performed on female patients of childbearing potential within
             24-48 hours before administration of radioactive material.

          7. Recovered from toxicity of any prior therapy.

          8. Able and willing to give valid written informed consent.

        Exclusion Criteria:

          1. Intercurrent medical condition that may limit the amount of antibody to be
             administered.

          2. Intercurrent medical condition that renders the patient ineligible for surgery.

          3. New York Heart Association Class III/IV cardiac disease.

          4. History of autoimmune hepatitis.

          5. Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the first cG250
             dose.

          6. Mental impairment that may compromise the ability to give informed consent and comply
             with the requirements of the study.

          7. Lack of availability for immunological and clinical follow-up assessments.

          8. Participation in any other clinical trial involving another investigational agent
             within 4 weeks prior to enrollment.

          9. Women who are pregnant or breastfeeding.

         10. Allergy to iodine.
A Study to Evaluate the Effects of Rifampin on Pharmacokinetics (PK) of Pevonedistat in Participants With Advanced Solid Tumors
Condition: Advanced Solid Neoplasm
Intervention: Pevonedistat; Rifampin; Docetaxel; Carboplatin; Paclitaxel
Intervention description: Pevonedistat intravenous infusion.; Rifampin capsules.; Docetaxel intravenous infusion.; Carboplatin intravenous infusion.; Paclitaxel intravenous infusion.
Intervention MeSH terms: Rifampin; Paclitaxel; Docetaxel; Carboplatin; Pevonedistat
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to assess the effect of multiple-dose administration of rifampin
      on the single dose PK of pevonedistat in adult participants with advanced solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult participants who have a histologically or cytologically confirmed metastatic or
             locally advanced solid tumor that is appropriate for treatment with either docetaxel
             or carboplatin + paclitaxel in Part B of this study, or have progressed despite
             standard therapy, or for whom conventional therapy is not considered effective.

          2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

          3. Expected survival of at least 3 months from the date of enrollment in the study.

          4. Recovered (that is, less than or equal to (<=) Grade 1 toxicity) from the effects of
             prior antineoplastic therapy.

          5. Adequate organ functions (kidney, liver, cardiac, bone marrow).

          6. Suitable venous access for the study-required blood sampling (including PK sampling).

        Exclusion Criteria:

          1. Prior treatment with radiation therapy involving greater than or equal to (>=) 25% of
             the hematopoietically active bone marrow.

          2. Life-threatening illness or serious (acute or chronic) medical or psychiatric illness
             unrelated to cancer.

          3. Active, uncontrolled infection or severe infectious disease.

          4. Known human immunodeficiency virus (HIV) seropositive or known hepatitis B or
             hepatitis C infection.

          5. With significant heart or pulmonary disease.

          6. Requiring chronic treatment with breast cancer resistance protein (BCRP) inhibitors.

        Criteria for Continuation into Optional Part B:

        To be eligible for Part B, participants must have completed Part A and be reassessed to
        determine if they meet the continuation criteria for Part B.
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.