bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of SC Injected Tc 99m Tilmanocept Localization in Active RA Subjects by SPECT and SPECT/CT Imaging
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tilmanocept
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rheumatoid arthritis; Tilmanocept; Imaging

Summary:

      Determine the localization of Tc 99m tilmanocept by SPECT and SPECT/CT imaging in subjects
      with active RA and concordance with clinical symptomology.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject has provided written informed consent with HIPPA authorization before the
             initiation of any study-related procedures.

        CONTROLS:

          -  The subject is between 21-45 years of age at the time of consent.

          -  The subject has not experienced joint pain for at least 4 weeks prior to the consent
             date and is deemed to be clinically free of any inflammatory disease(s).

        ACTIVE RHEUMATOID ARTHRITIS

          -  The subject is at least 21 years of age at the time of consent.

          -  The subject has moderate to severe RA, based on either the 1987American College of
             Rheumatology (ACR) score of ≥ 4/7 or the 2010 ACR/EULAR score of ≥ 6/10.

          -  The subject has a DAS28 of >4.4 (using the ESR).

          -  If the subject is on methotrexate, they have been at a stable dose for > 4 weeks prior
             to the screening visit.

          -  If the subject is on biologic therapy, they have been at a stable dose > 8 weeks prior
             to the screening visit.

          -  If the subject is on non-steroidal anti-inflammatories (NASIDS) or oral
             corticosteroids, it is ≤ 10mgmg/day or equivalent, and has been at a stable dose for >
             4 weeks prior to the screening visit.

        Exclusion Criteria:

          -  The subject is pregnant or lactating.

          -  BMI >32.0.

          -  The subject has had or is currently receiving chemotherapy for a non-inflammatory
             related condition or radiation therapy.

        Chronic or persistent infection or has any condition that would, in the opinion of the
        examining physician, preclude their participation.

          -  The subject has a known allergy to or has had a reaction to dextran exposure.

          -  The subject has received an investigational product within 30 days prior to he Tc99m
             tilmanocept administration.

          -  The subject has received any radiopharmaceutical within 7 radioactive half-lives of
             that radiopharmaceutical prior to the administration of Tc 99m tilmanocept.
Health Service Intervention for the Improvement of Access and Adherence to Colorectal Cancer Screening
Condition: Colorectal Carcinoma
MeSH terms: Colorectal Neoplasms
Intervention: Community Health Service; Survey Administration
Intervention description: Receive Witness CARES services; Ancillary studies
Phase: Phase 1
Study type: Interventional
Primary purpose: Health Services Research
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 183.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This phase I study investigates how well a health service program called Witness CARES
      Services works in increasing access and adherence to colorectal cancer screening in patients
      who have not undergone a colorectal screening in the past year. Providing patients with
      navigational and screening services via Witness CARES Services may improve access to and
      adherence levels of colorectal screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who are non-adherent to CRC screening over the past year (i.e., no stool
             testing in past 11 months or colonoscopy for over 9 years)

          -  Medicaid or Medicaid/Medicare subscribers

          -  Uninsured patients may be included from Mercy Comprehensive Care Center (MCCC), but
             will only be eligible for services to obtain fecal immunochemical tests (FIT) through
             the New York State (NYS) Cancer Services Program

        Exclusion Criteria:

          -  Any participants from the lists of gaps in care clients from insurance or primary care
             practices who report having had a colonoscopy in the past 9 years (or having positive
             findings such as polyps, 5 years) or having completed some type of fecal test for CRC
             will be excluded

          -  Participants under 50 will be excluded unless they have been deemed high risk by their
             physician, and have a prescription for CRC screening

          -  Participants symptomatic for CRC will be excluded from the study
Development of a mHealth Intervention for Ambivalent Smokers
Condition: Tobacco Use Disorder; Smoking Cessation; Motivation; Behavior, Smoking
MeSH terms: Tobacco Use Disorder
Intervention: Control mHealth program; Experimental mHealth program; Nicotine patch
Intervention description: The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.; The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.; Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
Intervention MeSH terms: Nicotine
Phase: Phase 1
Study type: Interventional
Primary purpose: Device Feasibility
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: mHealth; smoking; smoking cessation; motivation

Summary:

      The current pilot study will assess the feasibility and acceptability of a novel mHealth app
      designed for people who are ambivalent about quitting smoking. Results will be used to refine
      the intervention and plan for a future randomized effectiveness trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older;

          -  Can speak/read English;

          -  Current smoker;

          -  Own and regularly use an eligible smartphone;

          -  No vision impairments;

          -  Willing to install and use the study program;

          -  Willing to use birth control if elect to use nicotine replacement during the study
             (females);

          -  Meet definition for ambivalence

          -  Not actively using treatment

        Exclusion Criteria:

          -  Smoke less than 10 cigarettes per day

          -  Self-report a lifetime history of dementia, manic depression, bipolar disorder, or
             schizophrenia;

          -  Have medical contraindications for nicotine replacement therapy;

          -  Another household member is enrolled in the study

          -  Unable to verify contact information

          -  Fail to install app
A Study of a New LY900014 Formulation in Healthy Participants
Condition: Healthy
Intervention: LY900014; Insulin Lispro (Humalog)
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: Single (Participant)
Enrollment: 24.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is
      administered by injection under the skin of the abdomen. The study will be conducted in
      healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of
      different doses of LY900014 on blood sugar levels. Side effects and tolerability will be
      documented. The study will last for about 8 to 9 weeks for each participant, including
      screening and follow up. Screening is required within 28 days prior to entering the study.
    

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)

          -  Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m^2),
             inclusive, at screening

          -  Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine
             laboratory test results that are acceptable for the study

          -  Are nonsmokers, 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

        Exclusion Criteria:

          -  Are currently participating in or completed a clinical trial within the last 30 days
             or any other type of medical research judged to be incompatible with this study

          -  Have previously participated or withdrawn from this study

          -  Have or used to have health problems or laboratory test results or ECG readings that,
             in the opinion of the doctor, could make it unsafe to participate, or could interfere
             with understanding the results of the study
Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal Impairment
Condition: HCV Infection
MeSH terms: Hepatitis C; Renal Insufficiency
Intervention: Voxilaprevir
Intervention description: 100 mg tablet administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to evaluate the pharmacokinetics, safety, and
      tolerability of voxilaprevir (formerly GS-9857) in participants with severe renal impairment
      and matched healthy control participants.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  All individuals:

               -  Screening laboratory values within defined thresholds for group

               -  Use of two effective contraception methods if female of childbearing potential or
                  sexually active male

          -  For individuals with severe renal impairment:

               -  Stable chronic kidney disease

               -  Creatinine clearance (CLcr) < 30 mL/min

        Key Exclusion Criteria:

          -  All individuals:

               -  Pregnant or nursing female or male with pregnant female partner

               -  Hepatitis B virus, hepatitis C virus (HCV) or HIV infection

               -  History of clinically significant illness or any other medical disorder that may
                  interfere with the individual's treatment, assessment or compliance with the
                  protocol

          -  For individuals with severe renal impairment:

               -  Anticipated to require dialysis within 90 days of study dosing

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Study to Determine the Bioavailability and Food Effect of a Single TAK-935 Dose in Healthy Participants
Condition: Healthy Volunteers
Intervention: TAK-935 Tablets; TAK-935 Oral Solution
Intervention description: Tablets; Oral solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to assess the relative bioavailability (BA) of 300 milligram
      (mg) TAK-935 tablets compared to 300 mg of TAK-935 solution and to determine the effect of
      food on the BA of TAK-935 300 mg tablets in healthy adult participants.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Weighs at least 45 kilogram (kg) and has a body mass index (BMI) from 18.0 to 30.0
        kilogram per square meter (kg/m^2), inclusive at Screening and Day -2.

        Exclusion Criteria:

          1. Has received TAK-935 in a previous clinical study or as a therapeutic agent.

          2. Has a history of any psychiatric disorder as diagnosed utilizing Diagnostic and
             Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) criteria.

          3. Has any lifetime history of drug abuse (defined as any illicit drug use) or any
             lifetime history of alcohol abuse prior to the screening visit or is unwilling to
             agree to abstain from alcohol and drugs throughout the study. One unit is equivalent
             to a half-pint of beer or a single measure of spirits or 1 small glass of wine.

          4. Has a history of cancer, except basal cell carcinoma which has been in remission for
             at least 5 years prior to Day 1.

          5. Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus
             (HCV) antibody, human immunodeficiency virus (HIV) antibody at Screening or a known
             history of human immunodeficiency virus infection.

          6. Has used nicotine-containing products (including but not limited to cigarettes, pipes,
             cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to
             Check-In Day -1. Cotinine test is positive at Screening or Check-In (Day -1).

          7. Has poor peripheral venous access.

          8. Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including
             plasmapheresis), or had a transfusion of any blood product within 30 days prior to Day
             1 of Period 1.
A 2 Part Study to Assess the Relative Bioavailability of Tablet Formulation Compared to Capsule Formulation and the Effect of Food and Taste Assessment on the Tablet Formulation in Healthy Participants
Condition: Healthy Volunteers
Intervention: RO7017773 Phase I Capsule; RO7017773 Phase II Tablet Unflavored; RO7017773 Phase II Tablet Sweetened/Flavored
Intervention description: Participants will receive 1 single oral dose of RO7017773 Phase I Capsule.; Participants will receive 3 single oral doses of unflavored RO7017773 Phase II tablet during Part 1, and 1 single oral dose of unflavored RO7017773 Phase II tablet during Part 2.; Participants will receive 1 single oral dose of sweetened/flavored RO7017773 Phase II tablet during Part 2.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a two-part, open-label, healthy volunteer study. Part I will investigate the relative
      bioavailability of capsule and tablet formulations of RO7017773. Part II will explore how the
      taste of the tablet formulation is perceived with and without added sweetener/flavoring.
    

Eligibility criteria:

        Inclusion Criteria

          -  Non-smoker for at least six months

          -  Healthy, as judged by the Investigator

          -  Women of non-childbearing potential (WONCBP) who are not pregnant or lactating

          -  Men must be willing to remain abstinent or agree to use contraceptive measures with
             partners who are women of childbearing potential (WOCBP), and must refrain from
             donating sperm, for at least 28 days after the last dose of study drug

        Exclusion Criteria

          -  History or evidence of any medical condition potentially altering the absorption,
             metabolism or elimination of drugs

          -  History of convulsions (other than benign febrile convulsions of childhood) including
             epilepsy, or personal history of significant cerebral trauma or CNS infections (e.g.
             meningitis)

          -  A history of clinically significant hypersensitivity (e.g., drugs, excipients) or
             allergic reactions

          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities

          -  Have used or intend to use over-the-counter or prescription medication including
             herbal medications within 30 days prior to dosing

          -  Participation in an investigational drug or device study within 90 days prior to
             screening

          -  Human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies

          -  Presence of hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody test
             result at screening or within 3 months prior to starting study treatment
Use of Ravicti™ in Patients With MCAD Deficiency With the 985A>G (K304E) Mutation
Condition: Medium-chain Acyl-CoA Dehydrogenase (MCAD) Deficiency
Intervention: Ravicti
Intervention description: Open-label design comparing Ravicti at doses of 2, 4, and 6 grams/m2/day
Intervention MeSH terms: Glycerol
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Medium-chain acyl-CoA dehydrogenase deficiency; MCAD deficiency; MCADD; ACADM deficiency; MCADH deficiency; 985A>G mutation; K304E mutation; Ravicti; glycerol phenylbutyrate

Summary:

      This is a medical research study to test a medication in adult patients with a disease called
      medium-chain acyl-CoA dehydrogenase (MCAD) deficiency caused by at least one copy of the
      985A>G mutation. The medication is glycerol phenylbutyrate, called Ravicti, which is
      currently FDA approved for the treatment of urea cycle disorders. Previous research suggests
      that Ravicti may also be effective in the treatment MCAD deficiency. This study will
      investigate the safety and efficacy (how well it works) of Ravicti in patients with MCAD
      deficiency caused by having at least one copy of the 985A>G mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  confirmation of a diagnosis of MCAD deficiency

          -  at least one copy of 985A>G MCAD mutation

          -  ability to follow protocol

        Exclusion Criteria:

          -  positive pregnancy test

          -  currently breastfeeding

          -  currently taking any medication for which there is a potential drug interaction with
             Ravicti, includes corticosteroids, valproic acid, haloperidol, and probenecid

          -  liver or kidney insufficiency
Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study
Condition: Cocaine Dependence; Cocaine Addiction; Cocaine Abuse; Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Intervention: Clavulanic acid; Intravenous cocaine; Placebo
Intervention description: Clavulanic acid will be administered orally in 250mg capsules; 20/40mg Cocaine will be administered by IV; Placebo will be administered orally in capsules identical to CLAV and be filled with crystalline microcellulose
Intervention MeSH terms: Clavulanic Acids; Clavulanic Acid; Cocaine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Cocaine; Clavulanic Acid

Summary:

      The main purpose of this study is to determine if it is safe to use the study drug,
      clavulanic acid, in combination with cocaine. In this study, subjects will receive
      intravenous (i.v.) cocaine and the study drug, clavulanic acid. The safety of clavulanic acid
      is being studied so future studies can be done to find out if this drug is helpful in
      treating cocaine dependence. Currently, there is no available medication treatment for
      cocaine dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet Diagnostic and Statistical Manual of Mental Disorders Fifth Edition criteria for
             cocaine use disorder, moderate to severe.

          -  Be a non-treatment seeking cocaine user.

          -  If female and of childbearing potential, must have a negative pregnancy test within 48
             hours of beginning the study and be willing to use acceptable contraception or be
             abstinent for 14 days prior to study, through the entire study and 30 days after study
             participation.

        Exclusion Criteria:

          -  Be seeking treatment for substance abuse.

        (For full inclusion/exclusion criteria or for more information, please contact the site
        directly.)