bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LY3185643 and rGlucagon in Healthy Participants
Condition: Healthy
Intervention: LY3185643; rGlucagon
Intervention description: Administered SC; Administered SC
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 21 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine how the body handles LY3185643 and rGlucagon and
      what effects LY3185643 and rGlucagon have on the body. This study will also help to determine
      if LY3185643 is safe and well-tolerated.

      This study will last at least 35 days, not including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy as determined by medical history and physical examination

          -  Body mass index of 18.0 to 30.0 kilograms per square meter (kg/m²)

        Exclusion Criteria:

          -  Have participated, within the last 30 days, in a clinical trial involving an
             investigational product

          -  Known allergies to LY3185643 or rGlucagon, related compounds, or any components of the
             formulation

          -  History or electrocardiogram (ECG) evidence of heart block, or any abnormality in the
             12-lead ECG

          -  Abnormal blood pressure

          -  History of recurring symptomatic postural hypotension irrespective of the decrease in
             blood pressure, or asymptomatic postural hypotension at screening as defined as a
             decrease in systolic blood pressure greater than or equal to (≥) 20 millimeter of
             Mercury (mm Hg) within 3 minutes when changing from supine to standing position

          -  History of vasovagal response such as fainting

          -  History of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal,
             endocrine, hematological, or neurological disorders capable of significantly altering
             the absorption, metabolism, or elimination of drugs; of constituting a risk when
             taking the investigational product; or of interfering with the interpretation of data

          -  History of/current insulinoma and/or pheochromocytoma

          -  Have used systemic glucocorticoids within 3 months before entry into the study
Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers
Condition: Clostridium Infections
MeSH terms: Clostridium Infections
Intervention: Placebo (vaccine diluent); Clostridium difficile vaccine; Clostridium difficile vaccine; Clostridium difficile vaccine
Intervention description: 0.5 mL, intramuscular (IM) on Days 0, 28, and 56, respectively.; 0.5 mL, intramuscular on Days 0, 28, and 56, respectively.; 0.5 mL, intramuscular on Days 0, 28, and 56, respectively.; 0.5 mL, intramuscular on Days 0, 28, and 56, respectively.
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Clostridium difficile

Summary:

      The purpose of this study is to determine the safety and tolerability of a modified C.
      difficile vaccine at 3 dose levels compared with a placebo control administered via
      intramuscular injection in healthy adults aged 18-55 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult males or females, 18-55 years (inclusive)

          -  In good general health

          -  Clinical lab tests within normal range

          -  Non-pregnant female subjects

          -  Able and willing to participate for duration of study and must not participate in any
             other experimental study for at least 60 days after receiving the last dose of study
             vaccine

        Exclusion Criteria:

          -  Evidence of C. difficile infection

          -  Evidence of any previous antibiotic-associated diarrhea

          -  Active or inactive inflammatory bowel disease, irritable colon syndrome, chronic
             abdominal pain or other chronic diarrhea

          -  History of malignancy within 5 years

          -  History of anaphylaxis, asthma or severe vaccine or severe allergic drug reaction

          -  Known or suspected history of immunodeficiency;

          -  Active or inactive immune-mediated or inflammatory disease;

          -  Pregnant or lactating female subjects;

          -  History of drug or alcohol abuse disorders;

          -  Serology positive for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C virus
             (HCV)

          -  Receipt of antibiotic therapy or an investigational drug within prior 30 days

          -  Blood or organ donation within prior 30 days
Simplified Negative Pressure Wound Therapy
Condition: Wounds
MeSH terms: Wounds and Injuries
Intervention: simplified negative pressure wound therapy device (Wound Pump device)
Intervention description: A non-powered negative pressure device utilizing a bellows attached to a specialized dressing via drainage tube to promote healing of open wounds.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 14 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: wound; negative pressure wound therapy; non-powered negative pressure wound therapy

Summary:

      The objective of this study is to implement a simplified Negative Pressure Wound Therapy
      (sNPWT) device in a low resource setting. The investigators hypothesize that the sNPWT device
      is at least equivalent to commercially available NPWT devices. Therefore, the specific aims
      of this study will be to measure: 1. the mechanical properties of the sNPWT device and 2. the
      adverse events associated with the sNPWT device.
    

Eligibility criteria:

        Inclusion Criteria:

          -  open wound appropriate for NPWT

          -  wound size greater than 2 cm2 and less than 150 cm2

          -  adequate adjacent intact skin for application of sNPWT

          -  adequate contour of wound location for application of sNPWT

          -  patient is expected to tolerate change of the NPWT dressing with the chosen analgesia
             and sedation plan by the treating physician

          -  the patient is expected to remain clinically stable for the duration of the study

          -  the patient is to remain hospitalized for the duration of the study

          -  patient or their legal representative is willing and able to sign an IRB-approved
             informed consent

          -  patient less than 21 years old is willing to sign an approved assent form if able to
             sign

        Exclusion Criteria:

          -  exposed blood vessels

          -  ischemic wound

          -  wound with necrotic tissue requiring further debridement at the time of enrollment

          -  infection

          -  acute osteomyelitis

          -  malignancy in the wound

          -  latex or rubber containing product sensitivity
A Study of Aprepitant (MK-0869) in Pediatric Participants Undergoing Surgery (MK-0869-148)
Condition: Postoperative Nausea and Vomiting
MeSH terms: Vomiting; Postoperative Nausea and Vomiting
Intervention: Aprepitant; Ondansetron
Intervention description: Aprepitant administered orally or intraveously.; Ondansetron administered intravenously.
Intervention MeSH terms: Ondansetron; Aprepitant
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 98.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This two part study will determine the appropriate dosing regimen of aprepitant for the
      prevention of postoperative nausea and vomiting (PONV) in pediatric participants 6 months to
      17 years of age, by assessing pharmacokinetic parameters and monitoring safety and
      tolerability of administered doses. Part I will be an open label investigation of a single
      dose of aprepitant measuring pharmacokinetics at specified time points up to 48 hours after
      aprepitant dosing. Part II will be a double blind trial of participants randomized to receive
      either aprepitant or ondansetron.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is scheduled to have surgery requiring a 48 hour (Part I) or 24 hour (Part
             II) hospital stay

          -  Participant is scheduled to receive general anesthesia

          -  Participant is scheduled to receive opioids (e.g. morphine or fentanyl)

          -  Female participants of childbearing potential must have negative pregnancy test prior
             to drug administration

          -  A female participant who is of reproductive potential must agree to remain abstinent
             or use a barrier form of contraception for at least 14 days prior to, throughout, and
             for at least one month following the last dose of study medication

          -  Participant weighs 6 kg or more

        Exclusion Criteria:

          -  Participant is undergoing surgery for a life-threatening condition

          -  Participant is pregnant or breast feeding

          -  Participant has vomited within 24 hours prior to surgery

          -  Participant has a known history of QT prolongation or is currently taking other
             medicinal products that lead to QT prolongation

          -  Participant has an active infection (e.g., pneumonia), congestive heart failure,
             bradyarrythmia, any uncontrolled disease (e.g., diabetic ketoacidosis,
             gastrointestinal obstruction), evidence of any clinically significant respiratory,
             metabolic, hepatic, renal dysfunction, or a history of any illness, including morbid
             obesity, that might pose unwarranted risk
Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects
Condition: Drug Interactions
Intervention: Proellex; CYP1A2 probe; CYP2C9 probe; CYP2C19 probe; CYP2D6 probe; CYP3A4 probe
Intervention description: 2, 25 mg Proellex capsules administered daily; Caffeine (200 mg); Tolbutamide (250 mg); Omeprazole (20 mg); Dextromethorphan (30 mg); Midazolam (2mg)
Intervention MeSH terms: Tolbutamide; Midazolam; Dextromethorphan; Caffeine; Omeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Female
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug-drug interactions; DDI

Summary:

      This study will assess possible drug-drug interactions with specific isoenzymes over a total
      study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples
      collected post dose will be analyzed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult females

          -  A body mass index between 18 and 30 kg/m2, inclusive

          -  Negative urine drug and alcohol screen .

        Exclusion Criteria:

          -  Significant medical condition,

          -  Significant physical examination finding

          -  Clinical laboratory

          -  ECG abnormality

          -  CYP2D6 "poor metabolizer"
Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP)
Condition: Familial Adenomatous Polyposis
MeSH terms: Colorectal Neoplasms; Nasopharyngeal Neoplasms; Adenomatous Polyposis Coli
Intervention: Black raspberry (BRB) Slurry; Black Raspberry (BRB) Suppositories; Black Raspberry (BRB) Placebo Slurry
Intervention description: 20 grams BRB Slurry; Two, 730 mg BRB suppositories QHS; 20 grams BRB placebo slurry
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Polyp, Familial Adenomatous Polyposis, Prevention

Summary:

      This is a 36 week dietary intervention pilot study to evaluate the effects of lyophilized
      black raspberries on rectal polyp burden and biomarkers in subjects with FAP. Subjects will
      undergo a colonoscopy or sigmoidoscopy before study treatment to determine eligibility for
      the study. Eligible participants will undergo a sigmoidoscopy at 36 weeks after the
      initiation of study treatment. The size and number of rectal polyps will be documented on a
      code sheet and by photograph. The efficacy outcome will include the percentage reduction in
      the number of rectal polyps between baseline and 36 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of familial adenomatous polyposis with at least 5 rectal polyps which are
             greater than or equal to 2 mm on baseline colonoscopy

          -  Have an endoscopically assessable rectal segment

          -  Have not taken NSAIDs or selective COX-2 inhibitors for two months prior to the study
             and willing to remain off NSAIDs for the study duration.

        Exclusion Criteria:

          -  Known allergies or hypersensitivity to berries

          -  Diabetes mellitus

          -  Subjects taking NSAIDs or COX-2 inhibitors who cannot be taken off the medication due
             to their clinical condition.
A Study to Evaluate Biomarkers in Patients With Solid Tumors (0000-097)(COMPLETED)
Condition: Tumors
Intervention: Biomarker sample collection before and after dosing with cytotoxic agent(s); Biomarker sample collection before and after dosing with cytotoxic agent(s)
Intervention description: Participants will have blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine will be collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s).; A second group of participants will have blood and urine samples collected at Visit 1 (there is no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine will be collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      A study to evaluate biomarkers of cancer (context-specific sensitizers) in the skin of
      participants already receiving cytotoxic therapy. Additional blood and urine samples will be
      collected for phosphorylated Histone 2AX (γH2AX) and renal toxicity biomarker testing,
      respectively.
    

Eligibility criteria:

        Inclusion Criteria:

        Participant has solid tumor that will be treated with one of the following treatments:

          -  Gemcitabine monotherapy

          -  Cisplatin monotherapy

          -  Carboplatin monotherapy

          -  Gemcitabine and cisplatin combination therapy

          -  Gemcitabine and erlotinib combination therapy

          -  Gemcitabine and carboplatin combination therapy

          -  Cisplatin and vinorelbine combination therapy

          -  Cisplatin and pemetrexed combination therapy

          -  Carboplatin and vinorelbine combination therapy

          -  Carboplatin and pemetrexed combination therapy

        Exclusion Criteria:

          -  Participant has had recent cancer treatments including chemotherapy or radiation

          -  Participant has been in an investigational study within the last 30 days

          -  Participant has a history of drug or alcohol abuse

          -  Participant is Human Immunodeficiency Virus (HIV) positive or has a history of
             Hepatitis B or C
Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools
Condition: Adolescent Behavior
Intervention: Yoga-informed Health and Wellness Program; Physical Education Class
Intervention description: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June).; Standard physical education
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 112.0
Sex: All
Minimum age: 14 Years
Maximum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: stress; alternative; complementary; self-regulation

Summary:

      The purpose of this study is to compare the academic and psycho-social benefits of a
      yoga-informed health and wellness program (HWP) to a standard physical education program for
      middle and high school students within New York City (NYC) schools.
    

Eligibility criteria:

        Inclusion Criteria:

          -  • Male or female students attending NYC schools

        Exclusion Criteria:

          -  Lack of permission to attend physical education class
Oral AGY for Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Intervention: AGY
Intervention description: AGY is a natural health product produced in egg yolks
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All participants received open label AGY, a natural health product
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Celiac disease; AGY

Summary:

      Celiac disease (CD) is an autoimmune disease of the small intestine caused by the consumption
      of gluten proteins from widely used food sources such as wheat, rye, and barley. Exposure of
      the small intestine to gluten causes an inflammatory response, leading to the destruction of
      intestine lining, often with severe symptoms including diarrhea, abdominal distention,
      fatigue, weight loss, anemia, and neurological symptoms. CD is a lifelong disease and the
      only treatment currently available is strict adherence to a life-time gluten free diet (GFD).
      However, adhering to this diet is difficult as gluten proteins are found in many food
      products. Therefore, the gluten-free diet has both lifestyle and financial implications for
      the individual and thus has been potential for impacting adversely on their quality of life.

      Various approaches are being studied to reduce the need for careful control of the diet for
      those with CD, including the use of antibodies such as IgY. IgY is produced from the egg
      yolks of super immunized laying hens. Egg yolk antibodies are natural products with minimal
      toxicity, for those without egg allergy, and offer low-cost, hygienic production of study
      product. Once the IgY antibody is put into capsule form, it is called AGY.

      Individuals with CD will be recruited only if they have a history of biopsy proven CD,
      currently follow a GFD but continue to have mild to moderate symptoms related to gluten
      exposure, and do not have an egg allergy. Blood will be tested for ATG antibody levels at
      screening. Those enrolled will have a 2 week run-in period where diet and symptoms are
      recorded, and will then receive AGY capsules to take with meals over a 4 week period.
      Outcomes will be measured by examining lab test results including antibody levels, symptoms,
      and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 18 or over

          -  confirmed diagnosis of Celiac disease by previous biopsy

          -  follow a gluten-free diet (GFD)

          -  have mild to moderate symptoms despite the GFD diet

        Exclusion Criteria:

          -  diabetic

          -  use of steroids in previous year

          -  current use of ASA/NSAIDs, metronidazole, or misoprostol

          -  excess alcohol intake

          -  egg allergy

          -  history of severe complications of celiac disease or chronic active GI disease

          -  pregnancy
Study of CP-751,871 in Combination With Carboplatin and Paclitaxel in Advanced Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: CP-751,871 + carboplatin + paclitaxel
Intervention description: Chemotherapy (carboplatin and paclitaxel) and CP-751,871 (6, 10 or 20mg/kg) will be administered by intravenous infusion every three weeks.
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: CP-751,871, Non-small cell lung cancer, Phase 1

Summary:

      Investigate safety, tolerability and pharmacokinetics of CP-751,871 when given in combination
      with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of advanced non-small cell lung cancer

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Any prior treatment for non-small cell lung cancer

          -  Brain metastases

          -  With diabetes
Safety, Tolerability, and Pharmacokinetics of Dapsone in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Dapsone Formulation A; Dapsone Formulation B; Dapsone Formulation C; Dapsone 5% Gel
Intervention description: Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.; Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.; Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.; Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
Intervention MeSH terms: Dapsone
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 77.0
Sex: All
Minimum age: 16 Years
Maximum age: 35 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of dapsone in
      subjects with acne vulgaris following 28 days of dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of acne vulgaris

          -  Willing to avoid excessive or prolonged exposure to ultraviolet light (e.g., sunlight,
             tanning beds) throughout the study

          -  If male, the subject must agree to shave the facial treatment area and agree to
             maintain his routine shaving regimen for the duration of the study

          -  willing to avoid applying moisturizers, sunscreens, cosmetics (except eye and lip
             makeup), and chemical peels throughout the study

        Exclusion Criteria:

          -  Oral acne treatments within 6 months