bioihbjkbjnl/mcl2 huggingface dataset:
Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide in Healthy Male and Female Volunteers
Condition: Healthy
Intervention: Hyoscine butylbromide; Hyoscine butylbromide
Intervention description: sugar coated tablets for oral administration; drops for oral administration
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the current trial is to establish the bioequivalence of 2 hyoscine
      butylbromide dose forms following oral administration.
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male and female subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
A Phase 1b Study of MEDI4920 in Participants With Adult-onset Rheumatoid Arthritis
Condition: Adult Onset Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: VIB4920; Placebo
Intervention description: Participants will receive a single IV dose of VIB4920 Q2W from Day 1 up to 12 weeks.; Participants will receive a single IV dose of placebo matched to VIB4920 Q2W from Day 1 up to 12 weeks.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: MEDI4920, VIB4920, CD40L, RA, rheumatoid arthritis

Summary:

      The purpose of this study is to determine whether VIB4920 (formerly MEDI4920) is safe and
      well tolerated in participants with adult-onset rheumatoid arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult-onset rheumatoid arthritis

          -  swollen and tender joints

        Exclusion Criteria:

          -  venous thromboembolism or arterial thrombosis

          -  pregnant or breastfeeding

          -  positive hepatitis B, hepatitis C, and human immunodeficiency virus infection

          -  active or untreated latent tuberculosis
Single Rising Dose Study of BI 655088 Administered Intravenously in Healthy Male Volunteers
Condition: Healthy
Intervention: BI 655088; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 47.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Investigation of safety and tolerability of BI 655088 following intravenous infusion of
      single rising doses and exploration of the pharmacokinetics and pharmacodynamics of BI 655088
      after single dosing
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male subjects

          -  Age of 18 to 50 years

          -  Body mass index (BMI) of 18.5 to 29.9 kg/m2

          -  Additional inclusion criteria may apply

        Exclusion criteria:

          -  Any finding in the medical examination (including BP, PR or ECG) deviating from normal
             and judged as clinically relevant by the investigator

          -  Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg or
             diastolic blood pressure outside the range of 50 to 90 mmHg or pulse rate outside the
             range of 45 to 90 bpm

          -  Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          -  Any evidence of a concomitant disease judged as clinically relevant by the
             investigator

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          -  Diseases of the central nervous system (including but not limited to any kind of
             seizures and stroke), and other relevant neurological disorders or psychiatric
             disorders

          -  Additional exclusion criteria may apply
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
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: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which
      is a drug that lowers blood sugar. The study will look at how the body processes LY900014,
      and the effect of LY900014 on blood sugar levels following a standard meal. For each
      participant, the study will consist of 4 periods and will last approximately 12 weeks from
      screening to final study follow up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 40.0 kg/m²

          -  Have a glycated hemoglobin (HbA1c) less than or equal to (≤)9.0%

          -  Have a fasting C-peptide ≤1.0 nanomole per liter (nmol/L)

          -  Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn [NPH]
             insulin, insulin glargine or insulin detemir) with or without a stable dose of
             metformin for at least 3 months before screening

        Exclusion Criteria:

          -  Are currently enrolled, or have participated within the last 30 days, in a clinical
             trial or any other type of medical research

          -  Have or used to have health problems that, in the opinion of the doctor, could make it
             unsafe to participate in the study

          -  Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or
             provided any blood donation within the last month before screening

          -  Any significant changes in insulin regimen and/or unstable blood glucose control
             within the past 3 months prior to screening as assessed by the investigator

          -  Are treated with a CSII (insulin pump)

          -  Require daily insulin treatment greater than (>)1.2 units per kilogram per body weight
             (U/kg/body weight)
Clearance of 25-hydroxyvitamin D in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: d6-25-hydroxyvitamin D3
Intervention description: intravenous administration of stable isotope-labeled D6-25(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: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cystic fibrosis; vitamin d catabolism

Summary:

      The goal of this study is to define 25(OH)D3 catabolism in CF patients using gold standard
      pharmacokinetics studies. Specifically, the investigators will evaluate the metabolic
      clearance of 25(OH)D3 among participants with CF and matched control subjects. The goal of
      this work is to provide the first comprehensive characterization of vitamin D metabolism in
      CF patients and promote novel hypotheses for subsequent studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 18 years

          -  Serum total 25(OH)D 10-50 ng/mL

          -  Diagnosis of cystic fibrosis in accordance with CF Foundation Guidelines; OR, normal
             CONTROL

        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 or end stage renal disease treated with dialysis

          -  Use of vitamin D3 or vitamin D2 supplements exceeding a mean daily dose of 400 IU,
             within 3 months (wash-out allowed)

          -  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 < 9 g/dL
CBT With Disulfiram and Contingency Management
Condition: Cocaine Abuse
MeSH terms: Cocaine-Related Disorders
Intervention: disulfiram; Placebo; Placebo plus Contingency Management; Disulfiram plus Contingency Management
Intervention description: 250mg per day of Disulfiram plus CBT; Placebo plus CBT; Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT; 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT.
Intervention MeSH terms: Disulfiram
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: disulfiram; cognitive behavioral therapy; contingency management; drug abuse therapy; educational/resource design/development

Summary:

      This is a study of four treatments for chronic cocaine use and may help study participants to
      control their drug use. All participants will receive weekly individual cognitive behavioral
      therapy (CBT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-50 year old

          -  cocaine dependent

          -  willing to sign consent

          -  willing to accept randomization to intervention

        Exclusion Criteria:

          -  significant medical conditions

          -  psychiatric disorder with current use of prescribed psychotropic medication

          -  lifetime schizophrenia or bipolar disorder

          -  suicidality or homicidality

          -  unlikely to be able to complete 1 year follow up

          -  unable to speak or read English at a third grade level
Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine
Condition: Dengue
MeSH terms: Dengue
Intervention: D1ME100 (dengue-1 premembrane/envelope DNA vaccine)
Intervention description: IM injection delivered by Biojector
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue; DNA vaccine

Summary:

      The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Available to participate for the duration of the study (approximately 12 months)

          -  Completion and review of knowledge assement quiz

        Exclusion Criteria:

          -  Pregnant (by history or as ascertained by pregnancy test) or lactating female

          -  Female who intends to become pregnant during the study

          -  Plan to have elective surgery during the study period

          -  HIV infection

          -  Known immunodeficiency or currently receiving immunosuppressive therapy (inhaled and
             topical steroids are allowed)

          -  History of splenectomy

          -  Administration of a vaccine not foreseen by the study protocol during the period
             starting 30 days before each dose of vaccine and ending 30 days after vaccination

          -  Evidence of active (acute or chronic) hepatitis B or C infection

          -  Autoimmune diseaseor subjects who describe a first-degree relative with clearly
             documented autoimmune disease

          -  Acute or chronic, clinically significant cardiac, pulmonary, hepatic, or renal
             abnormality, as determined by physical examination or basic laboratory screening

          -  Clinical or laboratory evidence of significant anemia

          -  History of flavivirus infection or previous receipt of flavivirus vaccine

          -  Positive serology for flaviviruses (all four dengue virus serotypes, Japanese
             encephalitis, Yellow fever virus, and West Nile virus), HIV-1, Hepatitis B surface
             antigen, or anti-hepatitis C virus antibodies prior to enrollment

          -  Use of any investigational or non-registered drug or vaccine other than the study
             vaccine within 60 days preceding the first dose of study vaccine, or planned use
             during the study period.

          -  Previous history of allergic or anaphylactic reaction to any vaccine

          -  Planned travel to areas with endemic dengue during the study period

          -  Any other significant finding which, in the opinion of the investigator, would
             increase the risk of having an adverse outcome from participating in this protocol
Single Dose PG102 in Patients With Active Psoriatic Arthritis
Condition: Arthritis, Psoriatic
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: PG102; Placebo comparator
Intervention description: A single intravenous infusion; Phosphate-buffered saline
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The primary objective is to evaluate the safety and tolerability of a single intravenous dose
      of PG102 in patients with psoriatic arthritis. The secondary objectives are to evaluate how
      PG102 moves around the body and to explore its effects on the disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Arthritis that meets Classification of Psoriatic Arthritis (CASPAR) criteria

          -  Plaque psoriasis for at least 6 months prior to study enrollment

        Exclusion Criteria:

          -  Clinically significant psoriasis flare

          -  Unstable doses of pain relief medication

          -  Treatment with systemic corticosteroids other than prednisone ≤ 10 mg/day or
             equivalent

          -  Treatment with any biologic therapy

          -  Treatment with immunosuppressive agents or disease modifying anti-rheumatic drugs
             (DMARDs) other than methotrexate

          -  Treatment with lithium, any anti-malarial, chlorambucil, cyclophosphamide or therapies
             for psoriasis other than low potency topical corticosteroids on intertriginous and
             groin areas, tar or salicylate preparations on the scalp, and emollients and
             moisturisers

          -  Family history of multiple thrombotic events or a personal history of any venous or
             arterial thrombotic event

          -  Clinically significant result for anti-cardiolipin, Activated protein C resistance
             test, Protein C, Free Protein S, Antithrombin III, Factor V Leiden, Prothrombin
             variant, Homocysteine, Lupus anticoagulant, Prothrombin time, Activated partial
             thromboplastin time, Fibrinogen, Thrombin time, Factors IX and XI

          -  Currently smoking ≥ 10 cigarettes per day or equivalent

          -  Active tuberculosis or other infection

          -  Current or previous malignancies

          -  Clinically significant abnormality on physical examination, laboratory testing, vital
             signs or 12-lead electrocardiogram
To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Erenumab; Placebo; PACAP-38 Challenge Agent
Intervention description: Administered once on day 1 of Part B of the study by intravenous infusion.; Administered once on day 1 of Part B of the study by intravenous infusion.; Administered by intravenous infusion during Part A of the study for dose selection for Part B.
Administered by intravenous infusion on day 8 in Part B as a challenge agent to induce a migraine-like attack.
Intervention MeSH terms: Pituitary Adenylate Cyclase-Activating Polypeptide; Erenumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Migraine; Headache; Migraine Headache; Headache, Migraine; Amgen

Summary:

      Phase I, Randomized, Parallel-group, Double-Blind, Placebo-Controlled, Single Dose Study to
      Evaluate the Blockade of CGRP Receptor by AMG 334 in Preventing PACAP-38 Induced
      Migraine-like Attacks in Migraine Patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults ≥ 18 to ≤ 45 years of age upon entry into screening

          -  History of migraine headaches without aura for ≥ 6 months prior to screening according
             to the International Headache Society (IHS) International Classification of Headache
             Disorders (ICHD-II) (Headache Classification Committee of the International Headache
             Society, 2004) based on medical records and/or patient self-report

          -  Migraine frequency: ≥ 1 and ≤ 5 migraine days per month in each of the 3 months prior
             to screening

        Exclusion Criteria:

          -  History of migraine with aura, cluster headache or hemiplegic migraine headache
             according to the IHS Classification ICHD-II (Headache Classification Committee of the
             International Headache Society, 2004) based on medical records and/or patient
             self-report

          -  ≥ 6 migraine days per month in the last 3 months prior to study enrollment and during
             screening period

          -  Other headache disorders (except for episodic tension-type headache <5 days/month)
Study Evaluating the Pharmacokinetics of Venlafaxine Extended-Release (ER) and Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg in Healthy Subjects
Condition: Healthy
Intervention: Desvenlafaxine Succinate Sustained-Release (DVS SR); Venlafaxine Extended Release (VEN ER)
Intervention MeSH terms: Venlafaxine Hydrochloride; Desvenlafaxine Succinate
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Subjects

Summary:

      The purpose of this study is to determine if the relative difference in Pharmacokinetics (PK)
      between extensive metabolizers (EMs) and poor metabolizers (PMs) is the same with
      desvenlafaxine SR and venlafaxine ER when a single dose is administered.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men and women aged 18 to 55 years. Healthy as determined by the investigator
             on the basis of medical history and physical examination, laboratory test results,
             vital signs, and 12-lead electrocardiogram (ECG).

          -  History of being a nonsmoker for at least 1 year.

          -  Subjects have to be either extensive CYP2D6 metabolizers with a normal complement of 1
             or 2 fully active enzyme gene alleles or poor CYP2D6 metabolizers (lack of active
             enzyme gene alleles) via genetic testing of a blood sample.

        Exclusion Criteria:

          -  Presence or history of any significant cardiovascular, hepatic, renal, respiratory,
             gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or
             psychiatric disease or any severe conditions of the ears, eyes or throat (such as
             glaucoma or increased intraocular pressure).

          -  Known or suspected alcohol abuse or consumption of more than 2 standard units per day
             (a standard unit equals 12 ounces of beer, 1½ ounces of 80-proof alcohol, or 6 ounces
             of wine) within the past 6 months.

          -  Known or suspected current abuse of prohibited drugs or other substances. Use of any
             hormonal therapy within 30 days before study day -1 until the end of the partial
             inpatient confinement period.
Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)
Condition: Human Papilloma Virus; Cervical Cancer; Vulvar Cancer; Vaginal Cancer; Genital Warts
MeSH terms: Condylomata Acuminata; Papilloma; Vulvar Neoplasms; Vaginal Neoplasms
Intervention: Octavalent HPV with 15 mcg IMX / AAHS; Octavalent HPV with 30 mcg IMX / AAHS; Octavalent HPV with 60 mcg IMX / AAHS; Octavalent HPV with 120 mcg IMX / AAHS; Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™)
Intervention description: 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6; 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6; 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6; 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6; 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 158.0
Sex: Female
Minimum age: 18 Years
Maximum age: 24 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV)
      L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS)
      and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s)
      of IMX for further studies of the octavalent HPV L1 VLP vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is in good physical health

          -  Participant has had a lifetime history of 0 to 4 sexual partners

          -  Females between 18-to-24 years

        Exclusion Criteria:

          -  Participant has a history of abnormal Pap test

          -  Participant has a history of positive test for HPV

          -  Participant has a history of recent or ongoing alcohol or drug abuse

          -  Participant is immunocompromised or has an autoimmune condition

          -  Participant has received immunosuppressive therapy within a year of screening

          -  Participant has previously received an HPV vaccine

          -  Participant is pregnant

          -  Participant has a history of external genital/vaginal warts

          -  Participant is currently enrolled in a clinical trial

          -  Participant has a history of a severe allergic reaction that required medical
             attention