bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Mirikizumab in Participants With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Drug Cocktail; Mirikizumab
Intervention description: Drug cocktail consists of caffeine, warfarin plus vitamin K, omeprazole, dextromethorphan, and midazolam, administered orally; Administered SC
Intervention MeSH terms: Mirikizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is known as a "drug interaction study." The purpose is to learn how commonly used
      drugs or substances (midazolam, warfarin, dextromethorphan, omeprazole, and caffeine) and
      their breakdown products get into the bloodstream after taking a "cocktail" (combination) of
      them before and after multiple doses of mirikizumab.

      The study will last about 23 weeks for each participant. Screening must be completed within 4
      weeks prior to study start.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females with chronic plaque psoriasis for at least 6 months who are
             candidates for systemic therapy or phototherapy

          -  Have greater than or equal to (≥) 10 percent body surface area (BSA) involvement at
             screening and first admission to the clinical site

        Exclusion Criteria:

          -  Pregnant or nursing (lactating)

          -  History of an ongoing, chronic or recurrent infectious disease, or evidence of
             tuberculosis infection

          -  Have major surgery within 8 weeks prior to first admission to the clinical site or
             during the study

          -  Have a history of lymphoma, leukemia, or any malignancy

          -  Require treatment with the cocktail drugs within 14 days prior to the first
             administration of the drug cocktail through the end of Week 12 assessments

          -  Have participated in any other study with mirikizumab
Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Trastuzumab; BIBW 2992
Intervention description: Load: 4mg/kg-maintain:2mg/kg/week; Increased dose cohorts from low dose to MTD
Intervention MeSH terms: Trastuzumab; Afatinib
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
Healthy volunteers: No

Summary:

      Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with
      Herceptin®
    

Eligibility criteria:

        Inclusion criteria:

          1. Female patients aged >18 years.

          2. Advanced or metastatic breast cancer that over-expresses HER2 (immunohistochemistry 3+
             or 2+ and gene amplification by FISH). Prior treatment with Herceptin® or Lapatinib®
             (in the adjuvant or metastatic settings) is permitted but not required.

        Exclusion criteria:

        Patients with untreated or symptomatic brain metastases. Prior treatment with EGFR
        targeting therapies or treatment with EGFR- or HER2 inhibiting drugs within the past four
        weeks before the start of therapy or concomitantly with this study.
A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.
Condition: Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections; Cystic Fibrosis
Intervention: valganciclovir [Valcyte]
Intervention description: 900mg po
Intervention MeSH terms: Valganciclovir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 14 Years
Healthy volunteers: No

Summary:

      This study will assess the relative bioavailability of ganciclovir from the pro-drug
      valganciclovir in lung transplant recipients with or without cystic fibrosis. Each patient
      will receive 900mg valganciclovir daily for the period specified at their center, starting as
      soon as possible after the transplant. Pharmacokinetic assessments will be made provided that
      steady-state kinetics of ganciclovir and immunosuppressive drugs have been obtained (>=4 days
      of drug therapy). Blood samples for pharmacokinetic analysis will be taken up to 24h
      post-dose on one occasion. The anticipated time on study treatment is 3-12 months, and the
      target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female patients, >=14 years of age;

          -  first lung or heart-lung transplant recipient;

          -  at risk of CMV disease (D+R-,D+R+ or D-R+);

          -  estimated creatinine clearance >=60mL/min;

          -  stable immunosuppressive and 900mg Valcyte dosing regimens (>=4 days) prior to
             pharmacokinetic assessments.

        Exclusion Criteria:

          -  history of any adverse reaction to acyclovir, valacyclovir, ganciclovir or
             valganciclovir;

          -  evidence of graft rejection;

          -  patient has received anti-CMV prophylaxis with a treatment other than cytogam,
             ganciclovir or valganciclovir between transplant and screening.
Study of Tirzepatide in Healthy Participants
Condition: Healthy
Intervention: 14C Tirzepatide
Intervention description: Administered SC.
Intervention MeSH terms: Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 30 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to look at how much tirzepatide gets into the bloodstream and
      how long the body takes to get rid of it. This study will involve a single dose of 14C
      radiolabelled tirzepatide. This means that a radioactive tracer substance, C14, will be
      incorporated into the study drug to investigate the study drug and its breakdown products and
      to find out how much of these pass from blood into urine, feces and expired air.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the total duration of the clinical trial will be approximately 15 weeks, including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy males as determined by medical history, physical examination, and
             other screening procedures

          -  Have a body mass index (BMI) between 18.0 to 32.0 kilograms per meter squared (kg/m²),
             inclusive at screening

          -  Are willing to be available for the full duration of the study

        Exclusion Criteria:

          -  Have known allergies to tirzepatide or related compounds

          -  Have a medical condition or medical history that makes participation in the study
             unsafe or which may interfere in the interpretation of the results of the study

          -  Have had exposure to significant radiation within 12 months prior to dosing (for
             example, multiple x-ray or computed tomography [CT] scans, barium meal, being employed
             in a job requiring radiation exposure monitoring)

          -  Have participated in any clinical trial involving a radiolabeled substance within the
             past 12 months
COVID-19 Convalescent Plasma for Mechanically Ventilated Population
Condition: Covid-19
MeSH terms: COVID-19
Intervention: COVID-19 Convalescent Plasma
Intervention description: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if this plasma can be safely used in humans with COVID-19
      and to see if it can improve patients' health when they are sick with COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult ≥18 years of age

          2. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other authorized or
             approved assay in any specimen collected within 72 hours prior to enrollment. Note -
             An exception must be requested to the Sponsor if≥72 hours since positive test.

          3. Hospitalized, on invasive mechanical ventilation or ECMO, consistent with a clinical
             status assessment 8-point ordinal scale severity score of 7.

          4. Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g.,
             chest x-ray or CT scan).

          5. Patient or proxy is willing and able to provide written informed consent and comply
             with all protocol requirements.

        Exclusion Criteria:

          1. Contraindication to transfusion (e.g., severe volume overload, history of severe
             allergic reaction to blood products), as judged by the investigator.

          2. Clinical suspicion that the etiology of acute illness (acute decompensation) is
             primarily due to a condition other than COVID-19

          3. Receipt of other investigational therapy as a part of another clinical trial. a. Note:
             investigational therapies used as part of clinical care, (eg, remdesivir,
             hydroxychloroquine) are permissible.
A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: Omeprazole; Sotorasib
Intervention description: Omeprazole will be administered as an oral capsule.; Sotorasib will be administered as an oral tablet.
Intervention MeSH terms: Sotorasib; Omeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy volunteers; Sotorasib; AMG 510; Omeprazole

Summary:

      The primary objective of the study is to evaluate the effects of omeprazole (a proton-pump
      inhibitor) and an acidic beverage (Coca-Cola) on sotorasib pharmacokinetics (PK) when
      administered orally in healthy volunteers.
    

Eligibility criteria:

        Inclusion:

          -  Healthy male participants or female participants, between 18 and 60 years of age
             (inclusive), at the time of Screening.

          -  Body mass index, between 18 and 30 kg/m^2 (inclusive), at the time of Screening.

          -  Females of nonchildbearing potential.

        Exclusion:

          -  Inability to swallow oral medication or history of malabsorption syndrome.

          -  History of hypersensitivity, intolerance, or allergy to any drug compound, food, or
             other substance, unless approved by the Investigator (or designee) and in consultation
             with the Sponsor.

          -  Poor peripheral venous access.

          -  History or evidence, at Screening or Check in, of clinically significant disorder,
             condition, or disease, including history of myolysis, not otherwise excluded that, in
             the opinion of the Investigator (or designee), would pose a risk to participant safety
             or interfere with the study evaluation, procedures, or completion.
PF-06669571 In Subjects With Idiopathic Parkinson's Disease
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: PF-06669571; Placebo
Intervention description: 1 milligram (mg) QD for 3 days followed by 3 mg QD for 4 days; Placebo
Intervention MeSH terms: PF-06669571
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study is designed to assess safety, tolerability and pharmacokinetic data for multiple
      doses of PF-06669571 in subjects with idiopathic Parkinson's disease. In addition, this study
      will assess whether PF-06669571 is able to demonstrate superior efficacy compared with
      placebo in the treatment of the motor symptoms of idiopathic Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have a clinical diagnosis of idiopathic Parkinson's disease and presence
             of at least 2 out of 3 cardinal characteristics (tremor, rigidity and/or
             bradykinesia).

          -  Must be Hoehn & Yahr Stage II-III inclusive and experiencing motor fluctuations in the
             form of end-of-dose wearing off during the morning hours or early morning akinesia.

          -  Subjects should be able to recognize their "wearing off" symptoms and verify that they
             usually improve after their next dose of Parkinson's disease medication. Subjects
             should be able to recognize drug-induced dyskinesias and verify whether or not they
             are troublesome.

        Exclusion Criteria:

        - History or clinical features consistent with an atypical parkinsonian syndrome, (for
        example: ataxia, dystonia, clinically significant orthostatic hypotension.
A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women
Condition: Osteopenia
MeSH terms: Bone Diseases, Metabolic
Intervention: Romosozumab; Placebo
Intervention description: Administered by subcutaneous injection; Administered by subcutaneous injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: Female
Minimum age: 45 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Amgen; Phase 1; Postmenopausal; Japanese

Summary:

      The main purpose of this study is to assess the safety, tolerability and potential immune
      response to romosozumab following single subcutaneous (SC; injection under the skin) dose
      administration in healthy postmenopausal Japanese and non-Japanese women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese subjects must be first (4 grandparents, biologic parents and subject born in
             Japan), second (4 grandparents and biological parents born in Japan) or third (4
             grandparents born in Japan) generation Japanese

          -  Body mass index ≤ 25 kg/m², inclusive at screening

          -  Postmenopausal females defined as 12 continuous months of spontaneous amenorrhea
             confirmed by a serum follicle-stimulating hormone (FSH) result > 40 mIU/mL, or 6 weeks
             postsurgical bilateral oophorectomy (with or without hysterectomy) as documented in
             medical history (verified with an operative note, if available)

        Exclusion Criteria:

          -  Osteoporosis, as defined by bone mineral density (BMD) T-scores of the lumbar spine
             (L1-L4) or total evaluable vertebrae (if fewer than L1-L4); or femoral neck ≤ -2.5

          -  History of vertebral fracture or fragility fracture of the wrist, humerus, hip or
             pelvis;

          -  Diagnosed with any condition that will affect bone metabolism
A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED)
Condition: The Methodology Assessment of Glucose Dependent Insulin Secretion
Intervention: Comparator: exenatide; Comparator: exenatide; Comparator: Placebo
Intervention description: exenatide in two 5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 5mcg doses will be administered, followed by HCG or GGI.; exenatide in two 1.5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 1.5mcg doses will be administered, followed by HCG or GGI.; 5% osmitrol in two 60 mcL subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 60 mcL doses will be administered, followed by HCG or GGI.
Intervention MeSH terms: Exenatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 27.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will compare graded glucose infusion (GGI) to the hyperglycemic clamp (HGC) for
      assessment of glucose-dependent insulin secretion (GDIS) using exenatide as a probe.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has a Body Mass Index (BMI) of less than or equal to 26 kg/m2 at screening

          -  Subject is judged to be in good health

          -  Subject has been a nonsmoker for at least 3 months

          -  Subject is willing to avoid strenuous physical activity for the duration of the study

        Exclusion Criteria:

          -  Subject has a history of high blood pressure requiring treatment

          -  Subject has a history of diabetes or a family history of diabetes mellitus

          -  Subject is unable to discontinue all prescription and non-prescription drugs for
             duration of study

          -  Subject consumes more than 3 alcoholic beverages per day

          -  Subject consumes more than 6 servings of caffeinated beverages per day (1 serving =
             120mg caffeine)

          -  Subject has had major surgery or has donated or loss 1 unit of blood within 4 weeks of
             screening

          -  Subject has multiple and/or severe allergies to foods or drugs

          -  Subject is a regular user of illegal drugs

          -  Subject is unwilling or unable to consume the standardized meals during the study
             and/or is on a carbohydrate restricted diet
A Study of LY2510924 and Durvalumab in Participants With Solid Tumors
Condition: Solid Tumor
MeSH terms: Neoplasms
Intervention: LY2510924; Durvalumab
Intervention description: Administered SQ; Administered IV
Intervention MeSH terms: Durvalumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: immuno-oncology

Summary:

      The main purpose of this study is to evaluate the safety and tolerability of chemokine (C-X-C
      Motif) receptor 4 (CXCR4) peptide antagonist LY2510924 and durvalumab for phase 1a and 1b in
      participants with advanced refractory solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Phase 1a: Have histologic or cytologic confirmation of advanced solid tumor

          -  Have at least 1 measurable lesion assessable using standard techniques by Response
             Evaluation Criteria in Solid Tumours (RECIST) v1.1

          -  Have adequate organ function

          -  Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
             scale

          -  Have provided tissue from a newly obtained core or excisional biopsy of a tumor lesion
             or a recent biopsy defined by ≤3 years since last documented progression of disease

          -  Have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator

        Exclusion Criteria:

          -  Have a serious concomitant systemic disorder including human immunodeficiency virus
             (HIV), active hepatitis B virus (HBV), active HCV, active autoimmune disorder or
             disease requiring high dose of steroids

               -  Have a bowel obstruction, history or presence of inflammatory enteropathy or
                  extensive intestinal resection or chronic diarrhea

               -  Have evidence of interstitial lung disease that is symptomatic or may interfere
                  with the detection or management of suspected drug-related pulmonary toxicity or
                  active, noninfectious pneumonitis

               -  Have an active infection requiring systemic therapy

          -  Have had prior therapy with an anti-programmed cell death 1 (PD-1), anti-PD-L1,
             anti-PD-L2, or anticytotoxic T lymphocyte-associated antigen-4 antibody

          -  Moderate or severe cardiovascular disease

          -  Have symptomatic or uncontrolled brain metastases, spinal cord compression, or
             leptomeningeal disease requiring concurrent treatment

          -  Have received a live vaccine within 30 days before the first dose of study treatment