bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Safety, Pharmacokinetics, and Antiviral Activity of Bictegravir (GS-9883) in Human Immunodeficiency Virus (HIV)-1 Infected Participants
Condition: HIV-1 Infection
Intervention: Bictegravir; Placebo
Intervention description: Bictegravir tablet(s) administered orally once daily; Placebo to match bictegravir administered orally once daily
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: HIV-1 Infected; Adults; Treatment Naive

Summary:

      The primary objective of the study is to investigate the short-term antiviral potency of
      bictegravir at multiple doses in antiretroviral (ART) treatment-naive adult participants and
      participants who are ART-experienced but integrase strand transfer inhibitor (INSTI) naive.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  No current or prior anti-HIV treatment, including ART medications received for
             prevention (preexposure prophylaxis [PrEP]), or postexposure prophylaxis (PEP) within
             12 weeks of screening

          -  Plasma HIV-1 ribonucleic acid (RNA) ≥ 10,000 copies/mL but ≤ 400,000 copies/mL at
             screening

          -  Cluster of differentiation 4+ (CD4+) cell count > 200 cells/mm^3

        Key Exclusion Criteria:

          -  Anticipated to start HIV-1 therapy during the study period

          -  Active participation in another study of investigational or approved ART agents

          -  A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within
             the 30 days prior to screening

          -  Participants with positive hepatitis C antibody at screening

          -  Chronic hepatitis B virus (HBV) infection

          -  Active, serious infections (other than HIV-1 infection) requiring parenteral
             antibiotic or antifungal therapy within 42 days prior to Day 1 (baseline)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study of LY3303560 in Healthy Participants and Participants With Alzheimer's Disease (AD)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: LY3303560 - IV; Saline Solution - IV; LY3303560 - SC
Intervention description: Administered IV; Administered IV; Administered SC
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety and tolerability of the study drug,
      LY3303560. Side effects and laboratory results will be monitored. This study will involve
      single doses of LY3303560 administered intravenously (IV), meaning into a vein or
      subcutaneously (SC), meaning under the skin.

      Screening is required within 28 days before the start of the study for healthy participants
      and within 70 days before the start of the study for AD participants. The study requires
      about 16 weeks of each participant's time including a 4 day clinical research unit (CRU)
      admission and 10 follow-up appointments.

      This is the first time that this study drug is being given to participants. This study is for
      research purposes only, and is not intended to treat any medical condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy males or females of non-childbearing potential and who have given
             consent and are reliable and willing to make themselves available for the duration of
             the study and are willing to follow study procedures

          -  AD participants must be at least 50 years of age and have diagnostic criteria
             consistent with either mild cognitive impairment due to AD or mild-to moderate AD and
             have a positive florbetapir positron emission tomography (PET) scan

        Exclusion Criteria:

          -  Have known allergies to LY3303560, related compounds or any components of the
             formulation, or history of significant atopy

          -  Have an increased risk of seizures

          -  For AD participants, evidence of macrohemorrhage or greater than 4 microhemorrhage by
             magnetic resonance imaging (MRI)
Dose Finding Study of Vedolizumab for GvHD in Participants Undergoing Allogeneic HSCT
Condition: Allogeneic Hematopoietic Stem Cell Transplantation
Intervention: Vedolizumab
Intervention description: Vedolizumab Injection.
Intervention MeSH terms: Vedolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to assess the initial tolerability, safety and recommended phase
      2 dose of vedolizumab intravenous (IV) administered for GvHD prophylaxis along with standard
      GvHD prophylaxis therapy (in participants undergoing allogeneic hematopoietic stem cell
      transplantation [allo-HSCT]).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is undergoing matched or single-antigen mismatched unrelated-donor myeloablative
             transplant for the treatment of acute lymphoblastic leukemia (ALL) or acute myeloid
             leukemia (AML); Is less than or equal to (<=) 60 years of age.

             For the cohort after RP2D

          2. Is undergoing matched or single-antigen mismatched related or unrelated-donor
             transplant and receiving myeloablative conditioning or RIC for the treatment of
             hematologic malignancies or myeloproliferative neoplasms; Is less than or equal to
             (<=) 75 years of age.

        Exclusion Criteria:

          1. Has received prior allogeneic transplants or who are planned to undergo umbilical cord
             blood transplant, receive ex vivo T-cell-depleted hematopoietic stem cells (HSCs),
             received any in vivo T-cell depleting antibodies, or non-myeloablative conditioning.

          2. Has active cerebral/meningeal disease, active cytomegalovirus (CMV) colitis, or signs
             and symptoms of progressive multifocal leukoencephalopathy (PML) or any history of
             PML.

          3. Is undergoing transplant for the treatment of nonmalignant hematological disorders
             (for example: aplastic anemia, sickle cell anemia, thalassemias, Fanconi anemia).
A Study of Various Formulations of LY900014 in Healthy Participants
Condition: Healthy
Intervention: LY900014; Insulin lispro (Humalog)
Intervention description: Administered subcutaneously (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: Single (Participant)
Enrollment: 26.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the
      different formulations of LY900014. This study will determine how the different formulations,
      when injected under the skin, will affect the blood sugar levels in the body, and how safe it
      is.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy male or a female (not pregnant and agreeable to take birth control
             measures until one month after study completion)

          -  Must have a body mass index (BMI) of 18.0 to 30 kilogram per square meter (kg/m²)
             (inclusive) at the time of study screening

          -  Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine
             laboratory test results that are acceptable for the study

          -  Are non-smokers or have not smoked for at least 2 months prior to entering the study,
             and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the
             duration of the study

          -  Have veins suitable for easy blood collection and glucose solution infusion

        Exclusion Criteria:

          -  Have known allergies to insulin lispro or compounds related to these drugs, or any
             components of the study drug

          -  Show signs of having an infection or infectious disease at the time of study entry
Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: hypertonic saline (7%); isotonic saline
Intervention description: single treatment by inhalation; single treatment by inhalation
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects inhale isotonic saline on one imaging day and 7% hypertonic on the other. The order is randomized. There is a period of 5-24 days between imaging days.
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cystic fibrosis; nuclear medicine; aerosol; nebulizer

Summary:

      Blockage of the breathing tubes of the lungs by thick, sticky mucus is a major cause of lung
      problems for people with cystic fibrosis (CF). Many researchers now believe that people with
      CF absorb too much water from the insides of their lungs, and that the mucus in their lungs
      becomes so thick and sticky because there is not enough water in it. The investigators are
      trying to develop ways to measure how fast water is absorbed from the breathing tubes in the
      lung so that the investigators can more quickly test new medications that are being developed
      to fix this problem for CF patients. The investigators have already done studies showing that
      people with CF absorb a particular radioactive drug (Indium-111 diethylenetriaminepentaacetic
      acid or In-DTPA) from their lungs more quickly than people without CF. Now the investigators
      are trying to prove that the absorption of this drug is related to the absorption of water.
      The investigators measure the absorption of In-DTPA by delivering it in an aerosol (inhaled
      mist) along with another radioactive drug (Technetium 99m sulfur colloid or Tc-SC). This
      other drug helps us measure how much material is cleared from the lungs in other ways (like
      coughing) without being absorbed. In this study, the investigators will measure how the
      absorption of In-DTPA is affected by inhaling isotonic saline and hypertonic saline (salt
      water), both of which the investigators know affect the absorption of water in the airways.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age ≥ 18 years

          -  diagnosis of cystic fibrosis as determined by sweat test or genotype and clinical
             symptoms

          -  clinically stable as determined by the investigator (pulmonologist)

        Exclusion Criteria:

          -  intolerant to hypertonic saline.

          -  FEV1%p <40% of predicted

          -  nursing mother

          -  positive urine pregnancy test

          -  unwilling to stop hypertonic saline therapy for 72 hours prior to each test day

          -  cigarette smoker (regular smoking within 6 months of study)
Extended Use Protocol for Participants With Cancer to Receive Continued Treatment With CS-7017
Condition: Advanced Cancer
Intervention: CS-7017
Intervention description: CS-7017 administered orally, twice daily continuously for 6 weeks
Intervention MeSH terms: Efatutazone
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Healthy volunteers: No
Keywords: CS-7017; Advanced Cancer

Summary:

      This is a study of CS-7017 designed to allow participants who completed participation in a
      clinical study of CS-7017 without experiencing disease progression or unacceptable toxicity
      to continue treatment with study drug. Participants who have not progressed while receiving
      CS-7017 will continue to benefit from longer administration of the agent.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant previously treated with CS-7017 as part of a study that included CS-7017
             and has shown clinical benefits from treatment with CS-7017.

        Exclusion Criteria:

          -  Anticipation of need for a major surgical procedure or radiation therapy during the
             study.

          -  Any of the following conditions within 6 months prior to initiating study treatment:
             Myocardial infarction with significant impairment of cardiac function (eg, ejection
             fraction ≤ 50%), severe/unstable angina pectoris, coronary/peripheral artery bypass
             graft, New York Heart Association (NYHA) class II or higher congestive heart failure.

          -  Participants with clinically significant pleural or pericardial effusions.

          -  Clinically significant active infection, which requires antibiotic therapy, or human
             immune deficiency virus (HIV)-positive subjects receiving antiretroviral therapy.

          -  Participants with diabetes mellitus requiring treatment with insulin, sulfonylureas or
             thiazolidinediones (TZDs) agents, malabsorption syndrome, chronic diarrhea,
             inflammatory bowel disease, or partial bowel obstruction.
A Study of Lasmiditan in Healthy Chinese Participants
Condition: Healthy
Intervention: Lasmiditan; Placebo
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study of lasmiditan in healthy Chinese participants. The purposes are:

        -  To evaluate the safety of lasmiditan

        -  To learn more about how the body processes lasmiditan

      The study will last up to 50 days for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy Chinese (all 4 biological grandparents and both biological parents
             to be of Chinese origin) males or females, as determined by medical history and
             physical examination

          -  Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter, inclusive

          -  Are able and willing to give signed informed consent

        Exclusion Criteria:

          -  Have known allergies to lasmiditan, related compounds or any components of the
             formulation

          -  Have an abnormal blood pressure and/or pulse rate as determined clinically significant
             by the investigator

          -  Have a history of, show evidence of, or are undergoing treatment for significant
             active neuropsychiatric disease (for example, manic depressive illness, schizophrenia,
             depression)

          -  Have a history of central nervous system (CNS) conditions such as strokes, transient
             ischemic attack, significant head trauma, CNS infections, migraines, brain surgery, or
             any other neurological conditions that, in the opinion of the investigator, increases
             the risk of participating in the study

          -  Regularly use known drugs of abuse and/or show positive findings on drug screening
Dose Escalation Trial of Nitroglycerin, 5-flourouracil and Rad Therapy for Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Intervention: Nitroglycerin 0.2 MG/HR; Nitroglycerin 0.4 MG/HR; Nitroglycerin 0.6 MG/HR
Intervention description: 0.2mg/hr nitroglycerin transdermal patch daily. The first 3 patients will have a low dose patch applied (0.2 mg/hr).; 0.4mg/hr nitroglycerin transdermal patch daily. The first 3 patients will have a low dose patch applied (0.2 mg/hr) if this is well tolerated a higher dose patch (0.4mg/hr) will be used for the next 3 patients.; 0.6mg/hr nitroglycerin transdermal patch daily. The first 3 patients will have a low dose patch applied (0.2 mg/hr) if this is well tolerated a higher dose patch (0.4mg/hr) will be used for the next 3 patients and if this is well tolerated an even higher dose patch (0.6mg/hr) will be used.
Intervention MeSH terms: Nitroglycerin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: nitroglycerin; 5-flourouracil; radiation therapy; neo-adjuvant treatment

Summary:

      The purpose of this study is to determine whether topical nitroglycerin in addition to
      5-flourouracil and radiation therapy are effective in the treatment of operable rectal
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven Rectal Adenocarcinoma

          -  Histological diagnosis of operable T3-4, or T1-4 node positive, M0 rectal
             adenocarcinoma using endorectal ultrasound and/or MRI in addition to Computed
             Tomography (CT) of the chest, abdomen and pelvis for pre-study staging Acceptable
             alternatives for systemic staging instead of CT chest , abdomen, pelvis are CT abdomen
             and pelvis plus a Chest X-ray or a PET/CT

          -  Ability to give informed consent and willingness to adhere to study protocol

          -  Age ≥ 18 years and otherwise eligible to receive medical care at the Dallas VA Medical
             Center.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

          -  Adequate hematological, hepatic and renal function defined as in protocol.

        Exclusion Criteria:

          -  Any condition that would hamper informed consent or ability to comply with the study
             protocol

          -  Significant history of cardiac disease, e.g. uncontrolled hypertension, unstable
             angina, decompensated congestive-heart failure, myocardial infarction within the last
             six months or ventricular arrhythmias requiring medication.

          -  Pregnant and lactating women.

          -  Patients taking Phosphodiesterase - 5 inhibitors (e.g. Sildenafil, Vardenafil or
             Tadalafil) and is unable to stop for the duration of the chemoradiotherapy.
Encouraging Cognitive Screenings at African American Churches
Condition: Dementia; Healthy
MeSH terms: Dementia
Intervention: Project Grace
Intervention description: A multilevel church-based intervention to encourage cognitive screens and brain health.
Phase: Phase 1
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This pilot study plans to examine feasibility and outcomes of a
      culturally/religiously-tailored church-based dementia screening intervention among older
      adult African American church members and community members who use church outreach services
      in 4 African American churches.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥55

          2. Regular church member (attending church > monthly) or community member receiving
             church outreach services (>3 times annually)

          3. Willing to participate in two surveys (baseline and 4 months)

          4. Willing to provide contact information for at least 2 other persons

          5. Residing in the Kansas City metropolitan area

          6. Provide a working contact email address or number

        Exclusion Criteria:

          -  None
Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia Patients
Condition: Pediatric Patients With Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: High-dose trivalent inactivated influenza vaccine; Standard dose trivalent inactivated influenza vaccine
Intervention description: 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.; 0.5 mL standard dose trivalent inactivated influenza vaccine
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent
      inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with
      Acute Lymphoblastic Leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric patients with standard or high risk Acute Lymphoblastic Leukemia.

          -  Must be in 1st complete remission.

          -  Must be 4 weeks into maintenance therapy.

          -  17 years of age, inclusive.

          -  Available for duration of study.

        Exclusion Criteria:

          -  History of hypersensitivity to previous influenza vaccination or hypersensitivity to
             eggs/egg protein.

          -  History of Guillain-Barre syndrome.

          -  Evidence of relapsed disease.

          -  Have any condition that would, in the opinion of the site investigator, place them at
             an unacceptable risk of injury or render them unable to meet the requirements of the
             protocol.

          -  Have any condition that the investigator believes may interfere with successful
             completion of the study.

          -  History of receiving 2010 - 2011 influenza vaccine.

          -  Pregnant female.

          -  History of proven influenza disease after September 1, 2010.