bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity of Plant-Derived Pfs25 VLP-FhCMB Malaria Transmission Blocking Vaccine in Healthy Adults
Condition: Malaria
MeSH terms: Malaria
Intervention: Pfs25 VLP- FhCMB
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is a Phase 1, dose escalation, first-in-human study designed primarily to evaluate
      the safety of the purified plant-derived Pfs25 VLP combined with Alhydrogel adjuvant
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating female aged 18 - 50 years inclusive

          -  Able to give written informed consent obtained prior to screening

          -  Healthy, as determined by medical history, physical examination, vital signs, and
             clinical safety laboratory examinations at baseline

          -  Women of childbearing potential must have a negative urine pregnancy test within 24
             hours preceding receipt of each dose.

          -  Females should fulfill one of the following criteria:

               1. At least one year post-menopausal

               2. Surgically sterile

               3. Willing to use oral, implantable, transdermal or injectable contraceptives for 30
                  days prior to first vaccination and then for the study duration

               4. Willing to abstain from sexual intercourse or use another reliable form of
                  contraception approved by the Investigator (e.g., intrauterine device (IUD),
                  female condom, diaphragm with spermicide, cervical cap, use of condom by the
                  sexual partner or a sterile sexual partner) for 30 days prior to first
                  vaccination through 9 months after third vaccination

          -  Comprehension of the study requirements, as demonstrated by achieving a score of at
             least 80% correct on a short multiple-choice quiz.

               -  Individuals who fail to achieve a passing score on the initial comprehension
                  assessment will be given the opportunity to retest after a review of protocol
                  information.

               -  Individuals who fail the comprehension assessment for the second time will not be
                  enrolled.

          -  Available and able to participate in all planned study visits and procedures.

        Exclusion Criteria:

          -  History of malaria or previous receipt of an investigational malaria vaccine
A Study to Evaluate Corrected QT Interval and Drug-Drug Interaction of Trastuzumab on Carboplatin in the Presence of Docetaxel in Patients With HER2-Positive Metastatic or Locally Advanced Inoperable Cancer
Condition: Solid Cancers
Intervention: carboplatin; docetaxel; trastuzumab
Intervention description: Intravenous repeating dose; Intravenous repeating dose; Intravenous repeating dose
Intervention MeSH terms: Carboplatin; Docetaxel; Trastuzumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HER2+ Metastatic Cancer; HER2+ Locally Advanced Inoperable Cancer; HER2+ Solid Malignancy

Summary:

      This Phase Ib, multicenter, single-arm, open-label study is designed to evaluate the effect
      of trastuzumab on QTcF interval and to characterize the effects of trastuzumab on carboplatin
      pharmacokinetics in patients with HER2-positive metastatic or locally advanced inoperable
      cancer.

      The QT interval is a measure of time between the start of the Q wave and the end of the T
      wave in the heart's electrical cycle. The QTcF interval is the QT interval as calculated
      using Fridericia's correction; the QTcB interval is the QT interval as calculated using
      Bazett's correction.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic documentation of a HER2-positive solid malignancy in patients with
             metastatic or locally advanced inoperable disease

          -  Left ventricular ejection fraction (LVEF) >/= 50% by multiple-gated acquisition (MUGA)
             scan or two-dimensional echocardiography (ECHO) </= 42 days prior to Cycle 1, Day 1

        Exclusion Criteria:

          -  History of trastuzumab treatment </= 100 days prior to Cycle 1, Day 1

          -  Pretreatment QTcF interval > 450 ms as determined by local assessment
Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol
Condition: HCV Infection
MeSH terms: Hepatitis C
Intervention: SOF/VEL/VOX; VOX; Norgestimate/ethinyl estradiol
Intervention description: 400/100/100 mg FDC tablet administered orally once daily; 100 mg tablet administered orally once daily; Norgestimate 0.180 mg/0.215 mg/0.25 mg/ethinyl estradiol 0.025 mg tablet administered orally once daily according to the package insert
Intervention MeSH terms: Ethinyl Estradiol; Norgestimate; Norgestimate, ethinyl estradiol drug combination; Estradiol
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the effect of sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX)
      fixed-dose combination (FDC) + voxilaprevir on the pharmacokinetics (PK) of a representative
      hormonal contraceptive medication, norgestimate/ethinyl estradiol (Ortho Tri-Cyclen® Lo (OC))
      and will assess the effect of norgestimate/ethinyl estradiol on the PK of SOF/VEL/VOX+VOX.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal female

          -  Must have a calculated body mass index (BMI) ≥ 19.0 and ≤ 30.0 kg/m^2 at screening

          -  Must have a negative serum pregnancy test at screening and urine pregnancy test at Day
             -1

          -  Be willing and able to comply with all study requirements.

        Exclusion Criteria:

          -  Lactating female

          -  Have a history of any of the following:

               -  Significant drug sensitivity or drug allergy (such as anaphylaxis or
                  hepatoxicity)

               -  Known hypersensitivity to the study drugs, the metabolites or formulation
                  excipients

          -  Believed, by the study investigator, to be inappropriate for study participation for
             any reason
Effect of Rifampin on the Pharmacokinetics of Ixabepilone in Patients With Advanced Cancer
Condition: Advanced Solid Tumors; Neoplasms
Intervention: ixabepilone; Rifampin
Intervention description: ixabepilone solution, intravenous, 40 mg/m2, once every 3 weeks until disease progression; rifampin tablets, oral, 600 mg once daily, only on Days 15 to 21 of Cycle 1 and Days 1 to 7 of Cycle 2
Intervention MeSH terms: Rifampin
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: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test how rifampin affects the removal of BMS-247550
      (ixabepilone) from the body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Up to three prior chemotherapy regimens

          -  Measurable or non-measurable disease

          -  Available for treatment and follow-up

        Exclusion Criteria:

          -  Neuropathy

          -  Uncontrolled cardiovascular disease

          -  Refusal to participate in genetic analysis
A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
Condition: Infantile Colic; Infantile Functional Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Colic
Intervention: Nepadutant; Nepadutant
Intervention description: 0.1 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old); 0.5 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)
Intervention MeSH terms: MEN 11420
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 24 Weeks
Healthy volunteers: No
Keywords: Infantile colic; Abdominal Cramps; Colicky Pain; Functional gastrointestinal disorders

Summary:

      The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after
      single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral
      absorption is evaluated through the drug recovery in urine.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects will be eligible for inclusion in the study if they meet all of the following
        criteria:

          -  Infants with a history consistent with a diagnosis of colic or other functional
             gastrointestinal disorders

          -  Age >6 weeks and < 24 weeks

          -  At least 44 weeks post-conceptual age at enrolment

          -  Normal growth

          -  Informed consent by parents (one or both) or legal guardian

          -  Caregiver available to be trained in collection and storage of used diapers

          -  Caregiver available to record feeding episodes and defecations on the diary

        Exclusion Criteria:

        Subjects will be excluded from the study if they meet any of the following criteria:

          -  Clinical evidence of major cardiovascular, respiratory, renal, hepatic, endocrine,
             metabolic, gastrointestinal (excluding infantile colic and other functional
             gastrointestinal disorders, unless associated to symptoms which are likely to
             interfere with drug absorption, e.g. frequent vomiting), haematological, severe
             dermatological or neurological pathology or other diseases;

          -  Previous major surgery or blood loss

          -  Intake of antimuscarinic drugs, simethicone, or dimethicone 24 hours before study
             treatment administration.
Safety Evaluation of Advantage Anti-Caries Varnish
Condition: Dental Caries
MeSH terms: Dental Caries
Intervention: Varnish
Intervention description: Topical application to the teeth
Intervention MeSH terms: Imidacloprid
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 36 Months
Maximum age: 60 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to confirm the safety of Advantage Anti-Caries Varnish.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy

        Exclusion Criteria:

          -  Weight less than 15 kg or hypersensitivity to iodine
Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors
Condition: Advanced Cancer; Advanced Solid Tumors
MeSH terms: Neoplasms
Intervention: CP-751,871; Sunitinib
Intervention description: CP-751,871 IV, every 3 weeks; Sunitinib - daily dosing
Intervention MeSH terms: Sunitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study is being conducted to determine the maximum tolerated dose, overall safety and
      tolerability profile, and pharmacokinetic profile of CP-751,871 and sunitinib when given in
      combination with advanced solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed advanced solid tumors relapsed or refractory
             to standard therapy or for whom no standard therapy exists.

          -  ECOG Performance Status of 0 or 1;

          -  Total IGF-1 level ≥100 ng/ml;

          -  ECOG Performance Status of 0 or 1

          -  Adequate bone marrow, renal, and hepatic function

        Exclusion Criteria:

          -  Concurrent treatment with any antitumor agents with the exception of LHRH agnosits for
             prostate cancer patients

          -  Treatment with any other investigational therapy within 4 weeks prior to study
             treatment

          -  Major surgery within 4 weeks of study treatment

          -  Prior treatment that may increase the risk of cardiac complications

          -  Ongoing cardiac dysrhythmias of NCI CTCAE Grade 2 or greater

          -  Significant active cardiac disease, including hypertension that cannot be controlled
             by medications

          -  Greater than three (3) prior lines of cytotoxic therapy;

          -  Active infection

          -  Prior IGF-IR targeted therapy;
A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Ixabepilone; Capecitabine
Intervention description: Ixabepilone: Intravenous (IV) Solution, IV, 32(40)mg/m^2, once every 3 weeks, up to 6 cycles; Capecitabine: Tablets, Oral, 1650(2000)mg/m^2, twice daily for 2 weeks, one week off, up to 6 cycles
Intervention MeSH terms: Capecitabine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: Female
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the dose-limiting toxicity (DLT), maximum tolerated
      dose (MTD) and recommended Phase II dose of ixabepilone in combination with capecitabine in
      Japanese participants with metastatic breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women ≥ 20 years

          -  Histologically or cytologically confirmed diagnosis of adenocarcinoma originating in
             the breast

        Exclusion Criteria:

          -  Number of prior chemotherapy lines of treatment in the metastatic setting ≥3
A Dose-Escalation Study for Patients With Advanced Cancer
Condition: Advanced Cancer
MeSH terms: Neoplasms
Intervention: pegfilgrastim; LY2523355
Intervention description: Administered subcutaneously; Administered intravenously
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Cancer; Cancer

Summary:

      This study is being conducted to determine the safety of LY2523355 for the treatment of
      advanced and/or metastatic cancer (including Non-Hodgkin's lymphoma).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of advanced and/or metastatic cancer (solid tumors or Non-Hodgkin's
             lymphoma) that is refractory to standard therapy or for which no proven effective
             therapy exists. Participants entering the dose confirmation phase (Part B) of the
             study must also have a tumor that is safely amenable to serial biopsies

          -  Have the presence of measurable or nonmeasurable disease as defined by the Response
             Evaluation Criteria in Solid Tumors (RECIST) or Revised International Working Group
             Lymphoma Response Criteria

          -  Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
             scale

          -  Have discontinued all previous therapies for cancer, including chemotherapy,
             radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at
             least 28 days (6 weeks for mitomycin-C or nitrosoureas) prior to study enrollment

          -  Males and females with reproductive potential must agree to use medically approved
             contraceptive precautions during the trial and for 3 months following the last dose of
             study drug

          -  Females with child bearing potential must have had a negative urine or serum pregnancy
             test less than or equal to 7 days prior to the first dose of study drug

          -  Have an estimated life expectancy of greater than or equal to 12 weeks.

        Exclusion Criteria:

          -  Have symptomatic, untreated or uncontrolled central nervous system (CNS) metastases.
             Participants with treated CNS metastases are eligible provided their disease is
             radiographically stable, asymptomatic, and they are not currently receiving
             corticosteroids and/or anticonvulsants. Screening of asymptomatic participants without
             history of CNS metastases is not required

          -  Have current acute or chronic leukemia

          -  Have had an autologous or allogenic bone marrow transplant

          -  Females who are pregnant or lactating
Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects
Condition: Cataract Extraction
MeSH terms: Cataract
Intervention: Besifloxacin hydrochloride; moxifloxacin hydrochloride; gatifloxacin
Intervention description: Instill besifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.; Instill moxifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.; Instill gatifloxacin study medication in the study eye prior to making an incision for cataract extraction surgery.
Intervention MeSH terms: Moxifloxacin; Gatifloxacin; Besifloxacin; Norgestimate, ethinyl estradiol drug combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Screening
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bioavailability

Summary:

      This study is being conducted to assess the concentration of besifloxacin, moxifloxacin, or
      gatifloxacin in aqueous humor samples collected following topical instillation of the
      associated formulation in subjects undergoing cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are a candidate for a routine, uncomplicated, primary cataract
             extraction.

          -  Subjects who, in the Investigator's opinion, have potential for postoperative best
             corrected Snellen visual acuity of at least 20/200 in the study eye.

        Exclusion Criteria:

          -  Subjects who have a known sensitivity, contraindication, or allergy to the study
             medication(s) or their components.

          -  Subjects who had any corneal refractive surgery in the study eye.

          -  Subjects who have a history or presence of chronic generalized systemic disease that
             the Investigator feels might increase the risk to the subject or confound the result
             of the study.

          -  Subjects who had ocular surgery in the study eye, including laser procedures, within
             the past 6 months.

          -  Subjects who have taken any topical ocular medication in the study eye, other than
             those required by the protocol and permitted for surgery, during the 24 hours prior to
             the study medication being instilled.

          -  Subjects who use any antibiotics (e.g., systemic or topical) within the 7 days prior
             to the surgery date.

          -  Subjects who are monocular.
Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
Condition: Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL)
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Intervention: Acalabrutinib
Intervention MeSH terms: Acalabrutinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma; Diffuse Large B-Cell Lymphoma; de Novo Activated B-cell (ABC); de Novo Activated B-cell; ABC DLBCL; DLBCL; Lymphoma; B-Cell; Immunoproliferative Disorders; Immune System Diseases; Bruton's tyrosine kinase

Summary:

      To characterize the safety profile of acalabrutinib in subjects with relapsed or refractory
      de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age.

          -  Pathologically confirmed de novo ABC DLBCL

          -  Relapsed or refractory disease

          -  Subjects must have ≥ 1 measurable disease sites

        Exclusion Criteria:

          -  A life-threatening illness, medical condition or organ system dysfunction which, in
             the investigator's opinion, could compromise the subject's safety, interfere with the
             absorption or metabolism of acalabrutinib, or put the study outcomes at undue risk

          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
             congestive heart failure, or myocardial infarction within 6 months of screening, or
             any Class 3 or 4 cardiac disease as defined by the New York Heart Association
             Functional Classification, or LVEF < 50%

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
             resection of the stomach or small bowel or ulcerative colitis, symptomatic
             inflammatory bowel disease, or partial or complete bowel obstruction.

          -  Breast feeding or pregnant