bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
Condition: V600-mutated BRAF Unresectable Melanoma; V600-mutated BRAF Metastatic Melanoma; Stage III or Stage IV Metastatic Melanoma That Has Not Been Previously Treated With a Selective BRAF Inhibitor
MeSH terms: Melanoma
Intervention: PLX3397; vemurafenib
Intervention MeSH terms: Vemurafenib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to test the safety of an investigational new drug
      called PLX3397 when used in combination with Vemurafenib (Zelboraf™) at different dose
      levels. Vemurafenib has been approved by the United States Food and Drug Administration
      (FDA)/European Medicines Agency (EMA) for the treatment of a specific category of
      unresectable or metastatic melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥18 years old.

          -  Patients with histologically confirmed unresectable Stage III or Stage IV metastatic
             melanoma who have not been previously treated with a selective BRAF inhibitor.

          -  Presence of a BRAF V600 mutation in the tumor tissue using the cobas BRAF mutation
             assay or comparable standard of care methodology.

          -  Measurable disease per RECIST v. 1.1 criteria.

          -  ECOG performance status 0 or 1.

        Exclusion Criteria:

          -  Radiation therapy within 14 days of C1D1.

          -  Investigational drug use within 28 days of C1D1.

          -  Patients with active CNS lesions are excluded (i.e., those with radiographically
             unstable, symptomatic lesions). However, patients treated with stereotactic therapy or
             surgery are eligible if they remain without evidence of disease progression in the
             brain for ≥3 weeks.
Study Evaluating Single and Repeated Intravitreal Doses of ICON-1 in Patients With Uveal Melanoma
Condition: Uveal Melanoma; Choroid Neoplasm
MeSH terms: Melanoma; Uveal Neoplasms; Choroid Neoplasms
Intervention: ICON-1
Intervention description: Intravitreal injection of ICON-1
Intervention MeSH terms: Immunoconjugates
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, tolerability, biological activity,
      pharmacokinetics and pharmacodynamic activity of single and repeated escalating intravitreal
      doses of ICON-1 in patients with primary uveal melanoma who are planned to undergo
      enucleation or brachytherapy of the affected eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females of any race at least 18 years of age

          -  Clinical diagnosis of primary uveal melanoma involving the posterior uveal tract in
             the study eye

          -  Planned enucleation or brachytherapy of the study eye due to uveal melanoma

        Exclusion Criteria:

          -  Uveal melanoma in the study eye originating in the anterior uveal tract (iris)

          -  Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)

          -  Woman who is pregnant or lactating
A Study of LY2605541 in Healthy Participants
Condition: Healthy Volunteers
Intervention: LY2605541
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study looks at the amount of LY2605541 in the body after it is injected under the skin.
      The study has 3 periods, each lasting 10 days. Each participant will receive one injection in
      each period. At least 14 days will pass between each injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined by medical history and physical
             examination

          -  A body mass index of 18.5 to 30 kilograms per meter square (kg/m^2)

        Exclusion Criteria:

          -  Have a history or presence of 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 study medication; or of interfering with the
             interpretation of data

          -  Are women with a positive pregnancy test or are women who are lactating

          -  Intend to use over-the-counter medication within 7 days prior to dosing or
             prescription medication within 14 days prior to dosing (apart from contraceptive
             medication, vitamin/mineral supplements, occasional acetaminophen, and/or hormone
             replacement therapy)

          -  Have donated blood of more than 500 milliliters (mL) within the last month

          -  Have an average weekly alcohol intake that exceeds 21 units per week (for males) and
             14 units per week (for females)

          -  Are excessive consumers of xanthines (more than 10 cups of tea, coffee, cola, or hot
             chocolate per day)

          -  Have a fasting blood glucose (BG) >110 milligrams per deciliter (mg/dL) (6.1
             millimoles per liter [mmol/L])

          -  Currently smoke more than 10 cigarettes per day, or are unwilling to refrain from
             smoking for 72 hours prior to each dosing occasion and during confinement
Study Evaluating Single Ascending Doses of AAB-001 Vaccine SAD Japanese Patients With Alzheimers Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: bapineuzumab; bapineuzumab; bapineuzumab
Intervention description: The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.; The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.; The dose cohorts are as follows: 0.15 mg/kg AAB-001; 0.5 mg/kg AAB-001; 1.0 mg/kg AAB-001. Placebo is vehicle (all ingredients except active). In each dose cohort, designated as groups 1 to 3, study drug (AAB-001 or placebo) will be administered as an intravenous infusion over 1 hour.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 80.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      Evaluate safety, tolerability, and pharmacokinetics of single doses of the investigational
      AAB-001 Vaccine in Japanese patients with Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of AD

          -  Age 50-85

          -  MMSE 14-26

          -  Other Inclusion Criteria Apply

        Exclusion Criteria:

          -  Significant Neurological Disease

          -  Major Psychiatric Disorder

          -  Clinically Significant Systemic Illness

          -  Other Exclusion Criteria Apply
A Study to Investigate the Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Participants
Condition: Healthy Volunteers
MeSH terms: Malnutrition
Intervention: Entrectinib Test Formulation (F1); Entrectinib Reference Formulation (F06)
Intervention description: Participants will receive a single oral dose of entrectinib F1 after completion of a standardized meal.; Participants will receive a single oral dose of entrectinib F06 after completion of a standardized meal.
Intervention MeSH terms: Entrectinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study aims to investigate the relative bioavailability, safety, and tolerability of
      entrectinib capsule formulations F1 and F06 under fed conditions in healthy adult male and
      female participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy in the opinion of the investigator. Healthy is defined by the absence of
             evidence of any active disease or clinically significant medical condition based on a
             detailed medical history and examination

          -  Negative test results for Hepatitis B, Hepatitis C, and Human Immunodeficiency Virus
             (HIV)

          -  Females must not be pregnant or breastfeeding, and females of childbearing potential
             will agree to use highly-effective contraception. Females of childbearing potential
             must also agree to refrain from donating eggs during the treatment period and for 6
             weeks after the final dose of study drug

          -  Males must agree to use contraception and to refrain from sperm donation from check-in
             (Day -1 of Period 1) to 90 days after the final dose of study drug

        Exclusion Criteria:

          -  History of gastrointestinal surgery or other gastrointestinal disorder that might
             affect absorption of medicines from the gastrointestinal tract

          -  Presence of a clinically significant disease, illness, medical condition or disorder,
             or any other medical history determined by the investigator to be clinically
             significant and relevant. Ongoing chronic disorders which are not considered
             clinically significant are permissible providing they are stable

          -  Clinically significant change in health status, as judged by the investigator, or any
             major illness within the 4 weeks before screening, or clinically significant acute
             infection or febrile illness within the 14 days before screening

          -  Participation in any other clinical study involving an investigational medicinal
             product (IMP) or device within 30 days or 5 half-lives (if known), whichever is
             longer, before screening
Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases
Condition: Gastrointestinal and Gynecologic Malignancies
MeSH terms: Neoplasms
Intervention: Laparoscopic narrow band imaging; Standard white-light laparoscopy
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Adult patients evaluated at Lahey Clinic with known or suspected gastrointestinal or
      gynecologic malignancies and with an indication for diagnostic laparoscopy will be offered
      participation in the study. The proposed study is a randomized, controlled feasibility trial
      with crossover design. The study's aim is to evaluate the effectiveness of laparoscopic
      narrow band imaging (NBI) compared to standard white-light laparoscopy for detection of
      peritoneal cancer metastases. Study patients will undergo laparoscopic evaluation of the
      peritoneal cavity using a routine white-light videolaparoscope with the capability of NBI.
      The order of white-light and NBI laparoscopy will be randomized for each patient (crossover
      design). Frozen-section histopathology biopsies will be retrieved of all suspicious-appearing
      abnormalities using best clinical practices. The number of detected peritoneal metastases
      will be compared between each diagnostic laparoscopy technique. To gauge the rate of
      potentially missed metastases, peritoneal cancer recurrence will be surveyed through a 1-year
      follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients

          -  diagnosis or suspicion of malignancy of the gastrointestinal or gynecologic tract

        Exclusion Criteria:

          -  clinical contraindication to diagnostic laparoscopy
A Study of Vorinostat in Patients With Solid Tumors (MK-0683-029)
Condition: Tumors
MeSH terms: Neoplasms
Intervention: vorinostat
Intervention description: vorinostat 100 mg, 200 mg, 400 mg, or 500 mg single oral dose; once-daily or twice-daily administration
Intervention MeSH terms: Vorinostat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Solid tumors

Summary:

      The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the
      maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral
      suberoylanilide hydroxamic acid in participants with solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with histologically or cytologically diagnosed solid tumor; no standard
             therapy available or participant has failed to respond to standard therapy

        Exclusion Criteria:

          -  Participants with history of immunotherapy, radiotherapy, surgery, or chemotherapy
             during the previous 4 weeks; previous treatment is 5 or more chemotherapeutic
             regimens.

          -  Any uncontrolled concomitant illness

          -  Are pregnant or breast-feeding

          -  Serious drug or food allergy
Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male.
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: tamsulosin (Astellas); Tamsulosin HCL
Intervention MeSH terms: Tamsulosin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: Male
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Two tamsulosin HClformulations will be tested in fed state
    

Eligibility criteria:

        Inclusion criteria:

        Health male volunteers 18 years and older

        Exclusion criteria:

        History of hypersensitivity or allergy to IMP or its excipients or any related medication
Phase 1 Study of MLN0264 in Adult Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C
Condition: Advanced Gastrointestinal Malignancies
MeSH terms: Neoplasms
Intervention: MLN0264
Intervention description: MLN0264 30-minute infusion on Day 1 of each treatment cycle
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: 18 Years
Healthy volunteers: No
Keywords: Phase 1,; Advanced gastrointestinal malignancies,; MLN0264,; Guanylyl Cyclase C(GCC),; Antibody Drug Conjugate(ADC)

Summary:

      This is an Open-Label, Multicenter, Dose Escalation, First-in-Human Study of MLN0264 in Adult
      Patients With Advanced Gastrointestinal Malignancies Expressing Guanylyl Cyclase C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntary consent form

          -  Diagnosis of GI malignancy with a GCC protein expressing tumor

          -  Male or female patients 18 years or older with measurable disease as defined by
             Response Evaluation Criteria in Solid Tumors (RECIST)

          -  Female patients who are post menopausal, surgically sterile, or agree to practice 2
             effective methods of contraception or agree to abstain from heterosexual intercourse

          -  Male patients who agree to practice effective barrier contraception or agree to
             abstain from heterosexual intercourse

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Adequate bone marrow, hepatic and renal function as specified in the protocol

        Exclusion Criteria:

          -  Female patients who are lactating or have a positive serum pregnancy test during the
             screening period

          -  Any serious medical or psychiatric illness that could interfere with the completion of
             treatment

          -  Major surgery or treatment with investigational drug before the first dose

          -  Serious infection within 14 days before the first dose of study drug

          -  Known HIV, inflammatory bowel disease, viral hepatitis or cerebral/meningeal brain
             metastases

          -  Patients with cardiovascular conditions specified in protocols

          -  Patients with history of another primary malignancy not in remission for at least 3
             years

        Please note that there are additional inclusion and exclusion criteria. The study center
        will determine if you meet all of the criteria.

        Site personnel will explain the trial in detail and answer any question you may have if you
        do qualify for the study. You can then decide whether or not you wish to participate. If
        you do not qualify for the trial, site personnel will explain the reasons.
Brodalumab Drug-Drug Interaction (DDI) and Intensive Pharmacodynamic (PK) Study in Psoriasis Subjects
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Brodalumab
Intervention description: Group 1 consists of 20 subjects and will receive 2 oral doses of midazolam and a single SC dose of brodalumab. Group 2 consists of 10 subjects and will receive a single SC dose of brodalumab.
Intervention MeSH terms: Brodalumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a phase 1, multi-center, open-label, drug-drug interaction (DDI) and PK study in
      subjects with moderate to severe plaque psoriasis. It is designed to evaluate the effect of
      brodalumab on midazolam PK in addition to assessing single dose PK of brodalumab in subjects
      with moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has had stable moderate to severe plaque psoriasis for at least 6 months

          -  body mass index (BMI) between ≥ 18.0 and ≤ 38.0 kg/m2

          -  body weight between ≥ 50 and ≤ 130 kg

          -  no known history of active tuberculosis

        Exclusion Criteria:

          -  Female subjects who are lactating/breastfeeding

          -  History or evidence of clinically significant disorder, condition or disease that, in
             the opinion of the investigator or Amgen physician would pose a risk to subject safety
             or interfere with the study evaluation, procedures or completion.
Drug-drug Interaction Trial of BI 113608 in Combination With Ketoconazole and Voriconazole in Healthy Male Subjects
Condition: Healthy
Intervention: BI 113608; BI 113608; BI 113608; Ketoconazole; Voriconazole
Intervention description: tablet; tablet; tablet; tablet; tablet
Intervention MeSH terms: Ketoconazole; Voriconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this trial is to investigate the relative bioavailability of a
      single oral dose of BI 113608 without and with ketoconazole and voriconazole at steady state.
      The assessment of safety and tolerability of BI 113608 administered alone and upon
      co-administration will be an additional objective of this trial.
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions.
Study on Tolerability of Levodopa/Carbidopa in Children With Angelman Syndrome
Condition: Angelman Syndrome
MeSH terms: Angelman Syndrome; Syndrome
Intervention: Levodopa/Carbidopa (4:1)
Intervention description: Dosages are based on levodopa.
Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.
Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.
Intervention MeSH terms: Levodopa; Carbidopa
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 4 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Angelman syndrome; Levodopa; Carbidopa; L-dopa

Summary:

      This study is designed to determine the highest dose of levodopa/carbidopa that can be
      tolerated without any serious side effects by children with Angelman syndrome.

      It has been hypothesized that levodopa may lead to an improvement in the neurodevelopment and
      abnormal movements (e.g. tremors) in children with Angelman syndrome.

      Data from this study will be used to design a phase II trial to determine the efficacy of
      levodopa in treating children with Angelman syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Angelman syndrome, confirmed by molecular testing

          -  Must be willing to come for research visit on 2 days, exactly 1 week apart

        Exclusion Criteria:

          -  On levodopa, carbidopa, or any dopamine agonists in the 2 weeks prior to participation

          -  Other medical conditions that may be associated with developmental or cognitive delays

          -  More than 2 clinical seizures per month

          -  Used monoamine oxidase (MAO) inhibitors within the last 2 weeks

          -  Used phenytoin within the last 2 weeks

          -  Used phenothiazines, butyrophenones, and thioxanthenes within last 2 weeks

          -  Hypersensitive to levodopa or carbidopa

          -  Cardiovascular disease or instability

          -  Respiratory diseases, including asthma, emphysema, chronic cough, and shortness of
             breath

          -  Liver disease

          -  Stomach or intestinal ulcers

          -  Kidney disease

          -  Hematological problems, including anemia, leucopenia, and thrombocytopenia

          -  Used investigational drugs/interventions within the past three months