bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Tirzepatide; Placebo
Intervention description: Administered SC.; Administered SC.
Intervention MeSH terms: Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purposes of this study are to determine:

        -  The safety of tirzepatide and any side effects that might be associated with it.

        -  How much tirzepatide gets into the bloodstream and how long it takes the body to remove
           it.

        -  How tirzepatide affects the levels of blood sugar.

      This study includes eight weekly doses of tirzepatide or placebo given as subcutaneous (SC)
      injections just under the skin. The study will last about 16 weeks (total), including
      screening and follow-up. This study is for research purposes only and is not intended to
      treat any medical conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have T2DM controlled with diet and exercise alone or are stable on a single oral
             antidiabetic medication (metformin or dipeptidyl peptidase [DPP]-IV inhibitors)

          -  Have a body mass index of 20.0 to 35.0 kilograms per square meter, inclusive

        Exclusion Criteria:

          -  Have known allergies to tirzepatide, glucagon-like peptide (GLP)-1 analogs, or related
             compounds

          -  Have had more than 1 episode of severe hypoglycemia, as defined by the American
             Diabetes Association criteria, within 6 months before entry into the study or has a
             history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms

          -  Have an abnormality in the 12-lead electrocardiogram at screening that, in the opinion
             of the investigator, increases the risks associated with participating in the study

          -  Have a history or presence of pancreatitis or gastrointestinal (GI) disorder or any GI
             disease which impacts gastric emptying or could be aggravated by GLP-1 analogs or
             DPP-IV inhibitors
Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Recombinant Human C1 Esterase Inhibitor in Healthy Adult Subjects
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: Recombinant human C1 esterase inhibitor; Placebo; SHP623; Placebo
Intervention description: Subjects will receive escalating doses I-IV as both IV and SC injections; Subjects will receive matching placebo; SHP623; Placebo
Intervention MeSH terms: Complement C1s; Complement C1 Inhibitor Protein; Complement C1 Inactivator Proteins
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This trial is looking to gain information about the safety and tolerability of an
      investigational treatment (SHP623) in healthy adult volunteers. This study will also collect
      pharmacokinetic data (how the body absorbs and breaks down the study drug).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must be considered healthy. Healthy status is defined by absence of evidence of any
             active or chronic disease

          2. Male, or non-pregnant, non-lactating female, who agrees to comply with any applicable
             contraceptive requirements of the protocol, or females of non-child-bearing potential.

          3. Body mass index between 18.0 and 30.0 kg/m2 inclusive with a body weight >50 kg (110
             lbs.). This inclusion criterion will be assessed only at the first screening visit.

          4. Hemoglobin ≥12.0g/ld.

        Exclusion Criteria:

          1. Have a history of allergic reaction to C1 INH products (e.g. C1 Inhibitor [Human],
             Berinert [C1 Estrace Inhibitor (Human)] and C1 estrace [recombinant]

          2. Known history of alcohol or other substance abuse within the last year.

          3. Donation of blood or blood products within 60 days prior to receiving investigational
             product.

          4. Current use of any medication except hormonal replacement therapy, hormonal
             contraceptives and occasional use of any over-the-counter non-steroidal
             anti-inflammatory drug (NSAID) or acetaminophen.

          5. Have a history of hypercoagulability or other predisposition to thrombotic events.
Effects of Smoked Marijuana on Risk Taking and Decision Making Tasks
Condition: Marijuana Use Disorder
MeSH terms: Marijuana Abuse; Marijuana Use
Intervention: Inactive Marijuana (0% THC); Low THC marijuana (1.8 %THC); High THC marijuana (3.9% THC)
Intervention description: Placebo marijuana was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion.; Active marijuana (1.8 % THC) was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion.; Active marijuana (3.9%) was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion.
Intervention MeSH terms: Dronabinol
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking description: Double-blind, placebo-controlled
Enrollment: 36.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cannabinoids; Risk taking; Decision making

Summary:

      The purpose of this study is to investigate the effects of smoked marijuana on both risk
      taking and decision making tasks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current marijuana use

          -  21-45 years of age

          -  Practicing an effective form of birth control

          -  Not seeking treatment for marijuana use

        Exclusion Criteria:

          -  Current, repeated illicit drug use other than marijuana

          -  Presence of significant medical illness (e.g., diabetes, cardiovascular disease,
             hypertension)

          -  Laboratory tests outside normal limits that are clinically unacceptable to the study
             physician (BP > 140/90; hematocrit < 34 for women, < 36 for men)

          -  Significant adverse reaction to marijuana

          -  Current parole or probation

          -  Pregnancy or current lactation

          -  Recent history of significant violent behavior

          -  Major current Axis I psychopathology (e.g., mood disorder with functional impairment
             or suicide risk, anxiety disorder, schizophrenia

          -  History of heart disease

          -  Current use of any over-the-counter or prescription medication from which the
             volunteer cannot be withdrawn
Neuropathic Pain Syndrome Patient Study (MK-0000-072)
Condition: Neuralgia, Postherpetic; Diabetic Neuropathy; Painful Small-Fiber Neuropathy; Idiopathic Distal Sensory Polyneuropathy
MeSH terms: Neuralgia; Diabetic Neuropathies; Polyneuropathies; Small Fiber Neuropathy; Neuralgia, Postherpetic
Intervention: Comparator: pregabalin; Comparator: Placebo (unspecified)
Intervention description: pregabalin (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks; pregabalin Pbo (up to 600 mg/day by mouth (po)). Duration of Treatment: 6 Weeks
Intervention MeSH terms: Pregabalin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the best way to conduct clinical trials in patients
      with neuropathic pain (nerve pain). This study will see if generic pregabalin has any effect
      on neuropathic pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has moderate to severe nerve pain due to one of the following conditions:
             Postherpetic neuralgia, Painful diabetic neuropathy, Small fiber neuropathy or
             idiopathic distal sensory polyneuropathy

          -  Patient is able to complete questionnaires in either English or Spanish

          -  Patient is at least 18 years of age

        Exclusion Criteria:

          -  Patient is either pregnant or breastfeeding

          -  Patient has a history of angioedema (swelling beneath the skin surface) or peripheral
             edema (foot, leg, and/or ankle swelling)

          -  Patient has a history of congestive heart failure

          -  Patient has a seizure disorder

          -  Patient has a history of drug and/or alcohol abuse within the past 1 year

          -  Patient failed treatment due to lack of pain relief with more than three drugs for
             nerve pain

          -  Patient has had cancer (except basal cell carcinoma) within the past two years

          -  Patient anticipates the need for surgery while participating in the study

          -  Patient has a reported history of hepatitis B, C, or HIV infection

          -  Patient has another type of pain that is more painful than the nerve pain

          -  Patient has generalized anxiety disorder, untreated depression, psychosis, or
             post-traumatic stress disorder

          -  Patient is involved in litigation or receives worker's compensation related to nerve
             pain
Pharmacokinetics, Safety and Tolerability of the Combination of BI 207127 and Faldaprevir in Renal Impaired Patients
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Intervention: BI 207127; faldaprevir; BI 207127; BI 207127; BI 207127; faldaprevir; faldaprevir; faldaprevir
Intervention description: oral administration; oral administration; oral administration; oral administration; oral administration; oral administration; oral administration; oral administration
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the trial is to investigate the effect of different degrees of renal
      impairment on the pharmacokinetics and safety of the combination of BI 207127 and faldaprevir
      after 3 days of dosing (BI 207127 bid, faldaprevir qd) and a single dose of BI 207127 and
      faldaprevir on day 4.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy volunteers (males and females) or patients with impaired renal function
             (estimated glomerular filtration rate (eGFR) between 89 and 15) in relatively good
             health as determined by past medical history, physical examination, vital signs, ECG
             and laboratory assessments (aside from abnormalities specific for renal impairment)

          -  Age from 18 to 79 years

          -  Subjects must be able to understand and comply with study requirements

        Exclusion criteria:

          -  Any relevant deviation from healthy conditions for healthy volunteers

          -  Subjects with significant diseases other than renal impairment will be excluded. A
             significant disease is defined as a disease which in the opinion of the investigator:

               -  put the patient at risk because of participation in the study

               -  may influence the results of the study

               -  may influence the patients ability to participate in the study

               -  is not in a stable condition

          -  Diabetic or hypertensive patients can be entered in this trial if the disease is not
             significant according to these criteria
Study of Ixekizumab in Healthy Participants
Condition: Healthy
Intervention: Ixekizumab
Intervention description: Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the tolerability of injections of each of 3
      formulations of ixekizumab using a prefilled syringe. Information about any side effects
      (including injection site reactions [ISRs]) will be collected.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male participants or female participants who agree not to get pregnant

          -  Are male participants or female participants with chronic, stable medical problems
             that, in the investigator's opinion, will not place the participant at increased risk
             by participating in the study

        Exclusion Criteria:

          -  Have a significant history of, or current, cardiovascular, respiratory, hepatic,
             renal, gastrointestinal, endocrine, or hematologic disorders that in the opinion of
             the investigator poses an unacceptable risk to the participant if participating in the
             study

          -  Are allergic or hypersensitive to the study medicine

          -  Have dullness or loss of sensitivity on either side of your abdomen

          -  Have any condition that could affect pain perception from an injection

          -  Had a vaccination with a live vaccine within 12 months prior to the first check-in or
             intend to get a vaccine for tuberculosis within 12 months of completing treatment on
             this study

          -  Have any type of hepatitis, human immunodeficiency virus (HIV) infection, or other
             serious infection

          -  Show evidence of active or latent tuberculosis (TB)

          -  Presence of significant neuropsychiatric disorder or a recent history of depression

          -  Have excessive tattoos or scars over the abdomen or other factors such as rash or
             excessive folds of skin that would interfere with injection site assessments

          -  Have had any active or recent infection within 4 weeks of Day 1 that, in the opinion
             of the investigator would pose an unacceptable risk to the participant if
             participating in the study
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.
A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults
Condition: Healthy
Intervention: ALXN1840; Omeprazole
Intervention description: ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.; Omeprazole (20 milligrams) was administered orally as a delayed-release capsule in the morning of Days -5 to -1 and at Hour -1 on Day 1.
Intervention MeSH terms: Tetrathiomolybdate; Choline; Omeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study.
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ALXN1840; WTX101; Omeprazole

Summary:

      This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover
      study evaluating the PK of single doses of WTX101 in healthy participants based on the
      measurement of plasma total Molybdenum.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non-smoker

          -  Medically healthy with no clinically significant laboratory profiles, vital signs, or
             electrocardiograms.

          -  Body mass index ≥ 18 and ≤ 32.0 kilograms/meter squared.

          -  Willing and able to adhere to contraception requirements.

        Exclusion Criteria:

          -  Participant was mentally or legally incapacitated

          -  History or presence of clinically significant medical or psychiatric condition or
             disease.

          -  History of any illness that might have interfered with drug absorption.

          -  History or presence of hypersensitivity or idiosyncratic reaction to the study
             medications, study medication excipients.

          -  History or presence of alcoholism or drug abuse.

          -  Female participants who were pregnant or lactating.

          -  Positive results at screening for human immunodeficiency virus, hepatitis B surface
             antigen, or hepatitis C virus.

          -  Serum ceruloplasmin and copper values outside of the normal range at screening.

          -  On a diet incompatible with the on-study diet within the 28 days prior to the first
             ALXN1840 dose and throughout the study; unable to consume the contents of a high-fat
             breakfast.

          -  Participation in a previous clinical trial with ALXN1840.
Complementary Therapies in Palliative Care
Condition: Health Care Provider Education
Intervention: Online CE/CME course
Intervention description: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Palliative care represents one of the most rapidly expanding sectors of health care. Its
      rapid growth has been accompanied by widespread needs for training of multidisciplinary
      personnel to work with the unique set of health issues specific to its population of patients
      - not only those at end-of-life, but also patients with long-term, incurable, chronic and
      degenerative illnesses. This project will develop the first online continuing education
      program for palliative care personnel in the evidence-based application of complementary
      therapies, to enhance patient care and quality of life in the palliative care setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Physicians (MD, DO), physician assistant (PA), nurse practitioner (NP), registered
             nurse (RN), licensed practical nurse (LPN), social worker (BA/BS/BSW, MSW, PhD/DSW),
             psychologist (MS/MA, PhD/PsyD), counselor (MS/MA),administrator, and chaplain.

          -  Must be currently active within palliative care settings.

        Exclusion Criteria:

          -  Professionals not actively working in palliative care settings
Single-Dose Pharmacokinetics of BMS-790052 in Participants With Hepatic Impairment
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Intervention: BMS-790052
Intervention description: Capsules, Oral, 30 mg, single dose, one day
Phase: Phase 1
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the effects of hepatic impairment on the single dose
      pharmacokinetics of BMS-790052.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male and female subjects aged 18 to 70 years, with hepatic impairment conforming to
             Child-Pugh class A, B or C

          -  Healthy subjects to the extent possible matched to the first four hepatically impaired
             subject in each Child-Pugh class with regard to age (approximately ± 10 years), body
             weight (approximately ± 20%) and gender

        Key Exclusion Criteria:

          -  History of esophageal and gastric variceal bleeding within past 6 months

          -  Primarily cholestatic liver diseases

          -  Active alcoholic hepatitis

          -  Stable encephalopathy of >= Stage 2

          -  Presence of severe ascites or edema

          -  Presence of hepatopulmonary or hepatorenal syndrome

          -  Positive for HCV, unless HCV RNA is undetectable