bioihbjkbjnl/mcl2 huggingface dataset:
Memory Modulation by Pain During Anesthesia
Condition: Amnesia; Pain; Anesthesia
MeSH terms: Amnesia
Intervention: Dexmedetomidine; Midazolam; Peripheral nerve stimulation; Ketamine
Intervention description: Selected subjects received this drug during a portion of the study; Selected subjects received this drug during a portion of the study; Experimental acute pain stimulus was delivered using a nerve stimulator. These painful shocks were paired randomly with some of the auditory experimental cues.; Selected subjects received this drug during a portion of the study
Intervention MeSH terms: Midazolam; Dexmedetomidine; Ketamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: There are 3 single drug arms completed by a few participants. The majority of participants participated in a crossover design with two drugs, midazolam & ketamine.
Masking: Single (Participant)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: midazolam; dexmedetomidine; memory; ketamine

Summary:

      The purpose of this study is to determine the effects of pain on facilitating long-term
      auditory memory in the presence and absence of distinct intravenous anesthetics. The ability
      to identify previously presented words from a list assessed the degree of memory formation.
      In a subset of subjects, functional magnetic resonance imaging was used to identify the
      neural correlates of memory inhibition or facilitation by the combination of pain and
      anesthetic used.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult volunteers, with normal memory and hearing, whose native language is
             English

        Exclusion Criteria:

          -  pregnancy

          -  significant memory or hearing loss

          -  sleep apnea

          -  chronic pain

          -  metal or electronic implants

          -  claustrophobia

          -  Currently taking: antidepressants, anti-psychotics, antihistamines, anti-anxiety
             medication, stimulants, sleep-aids, or pain medication
A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella-Zoster Virus (VZV) Vaccine in Adults With Hematologic Malignancies (HM) Receiving Treatment With Anti-Cluster of Differentiation (CD) 20 Monoclonal Antibodies (V212-013)
Condition: Herpes Zoster
MeSH terms: Herpes Zoster; Chickenpox; Hematologic Neoplasms
Intervention: V212
Intervention description: V212 viral antigen for HZ
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      An open-label, multicenter study to evaluate the safety and immunogenicity of inactivated VZV
      vaccine (V212) in participants with hematologic malignancies (HM) who are currently receiving
      anti-CD20 monoclonal antibodies. The primary hypothesis is that vaccination with V212 vaccine
      will elicit significant VZV-specific immune responses at ~28 days after vaccination 4. The
      statistical criterion for significance requires that the lower bound of the 2-sided 90%
      confidence interval of the geometric mean fold rise in immune response in V212 recipients is
      >1.0.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with a HM and is receiving treatment with anti-CD20 monoclonal antibodies
             and is not likely to undergo hematopoietic cell transplant (HCT).

          -  Has a predicted life expectancy of ≥ 12 months.

          -  Has prior history of varicella or antibodies to VZV due to exposure to the disease in
             a country where the disease is common.

          -  All female participants of childbearing potential must have a negative serum or urine
             pregnancy test.

        Exclusion Criteria:

          -  A history of allergic reaction to any vaccine component (including gelatin) or an
             anaphylactic/anaphylactoid reaction to neomycin.

          -  Prior history of HZ within 1 year of enrollment.

          -  Prior receipt of any varicella or zoster vaccine.

          -  Participant is pregnant or breastfeeding or expecting to conceive within the period of
             2 weeks prior to enrollment throughout 6 months after last vaccination dose.

          -  Any live virus vaccine administered or scheduled in the period from 4 weeks prior to
             Dose 1 through 28 days postvaccination dose 4.

          -  Any inactivated vaccine administered or scheduled within the period from 7 days prior
             to, through 7 days following, any dose of study vaccine.

          -  Participant is currently participating or has participated in a study with an
             investigational anti-CD20 monoclonal antibody within 3 months of signing informed
             consent.
A Study To Test The Impact Of PF- 00299804 On How The Body Handles Dextromethorphan In Cancer Patients
Condition: Advanced Malignant Solid Tumors
MeSH terms: Neoplasms
Intervention: PF-00299804
Intervention description: PF-00299804: Patients take oral 45 mg PF-00299804 once daily starting on Cycle 1 Day 1 until disease progression or unacceptable toxicities occur. One cycle equals 21 days. Dextromethorphan: Patient take a single 30 mg oral dose of dextromethorphan HBr three days prior to Cycle 1 Day 1, and then on Cycle 2 Day 7.
Phase: Phase 1
Study type: Interventional
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase 1; PF-00299804; Dextromethorphan; CYP2D6 Inhibition; Cancer Patients

Summary:

      Research in test tubes suggests that may affect cytochrome P450 2D6 (CYP2D6), an important
      enzyme that is responsible for eliminating many drugs that cancer patients need to take,
      including dextromethorphan. The purpose of this study is to test the impact of PF-00299804 on
      the activity of CYP2D6, and how the human body handles dextromethorphan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a histologically or cytologically confirmed advanced malignant solid
             tumor for which there is no currently approved treatment or which is unresponsive to
             currently approved therapies;

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Patients with
             performance status 2 could be eligible upon agreement between sponsors and
             investigators;

          -  Adequate bone marrow, renal, liver and cardiac functions;

        Exclusion Criteria:

          -  History of Interstitial Lung Disease (ILD).

          -  Drugs with known CYP2D6 inhibitory effects

          -  Drugs that are highly dependent on CYP2D6 for metabolism.

          -  Women who are pregnant or breastfeeding.
This Is The First Study Using Escalating Doses Of PF-03758309, An Oral Compound, In Patients With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Intervention: PF-03758309
Intervention description: Oral PF-03758309 will be administered in capsules (once or twice daily) until toxicity, progressive disease, or patient refusal to continue on therapy. The starting dose is 1 mg once daily.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase 1 dose escalation dose finding pharmacokinetic and pharmacodynamic study

Summary:

      This is the first study using PF-03758309, an oral compound, in patients with advanced solid
      tumors. In this study different doses of PF-03758309 will be administered to different groups
      of patients. The study will assess the compound's safety, the blood levels of PF-03758309
      during the treatment and the effect of the compound on the tumor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced/metastatic solid tumor that is resistant to standard therapy or for which no
             standard therapy is available.

          -  ECOG (Eastern Cooperative Oncology Group) Performance Status (PS) must be 0 or 1.

          -  Adequate bone marrow, liver and kidney function.

        Exclusion Criteria:

          -  Patients with known brain metastases.

          -  Previous high dose chemotherapy requiring stem cell rescue.

          -  Prior irradiation to >25% of the bone marrow.

          -  Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C
             (HCV).

          -  Current active treatment in another clinical study.

          -  Pregnancy or breast feeding.

          -  Active inflammatory gastrointestinal disease, chronic diarrhea (unless related to
             underlying malignancy or prior related treatment) or history of abdominal fistula,
             gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within
             6 months prior to study enrollment.
Pharmacokinetic Study Of AGILE AG200-15 After Weekly Application Under Various Conditions in Healthy Female Volunteers
Condition: Healthy
Intervention: AG200-15
Intervention description: There will be three treatment periods. Subjects will be randomly assigned to one of the five conditions for the treatment period. The subject will be exposed daily to the condition assigned while wearing the patch. The study patch will be worn for a 7 day treatment period, followed by a 7 day washout period. The total duration of the study is 6 weeks.
Intervention MeSH terms: Contraceptive Agents
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetic Profile (PK) and Safety; PK analysis of EE and LNG

Summary:

      A study to evaluate pharmacokinetic profile, wearability and safety of AG200-15, transdermal
      delivery of levonorgestrel (LNG) and ethinyl estradiol (EE), under normal conditions and
      external conditions of heat, humidity, cold water and exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy women, ages 18-45

          -  Body mass index (BMI)of ≥18 and less than or equal to 32, and weight ≥ 110 lbs.

          -  Willing to use a non-hormonal method of contraception if of childbearing potential, or
             have already undergone previous bilateral tubal ligation or hysterectomy

          -  Willing to refrain from use of alcohol and grapefruit juice from 48 hours prior to
             patch application until completion of each treatment period

          -  Willing to give informed consent to participate in study

        Exclusion Criteria:

          -  Known or suspected pregnancy

          -  Breast-feeding or within 1 month after stopping breast-feeding

          -  Smokers

          -  Any disease that may worsen with hormonal treatment

          -  Hypersensitivity to transdermal preparations or sensitivity to surgical/medical tape
A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma
Intervention: KCP-330
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bone sarcoma; Soft-tissue sarcoma; Sarcoma; KPT-330; Food; Effects; Selinexor

Summary:

      The purpose of this research study is to find out more information such as: to determine the
      effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets and to
      compare PK of capsules and tablets in Arms 1 and 2; to evaluate tumor response in sarcoma
      participants in Arm 3; to compare the PK of 60 milligrams (mg) of the new, 2nd generation
      tablet formulation and 60 mg of the selinexor suspension formula to the current, 1st
      generation tablets.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have histologically confirmed soft tissue or bone/cartilage sarcoma.
             Patients with sarcoma of small round blue cell tumor types are allowed.
             Gastrointestinal stromal tumors (GIST) are excluded.

          2. Patients must have received at least one prior anticancer regimen for metastatic
             disease unless there is no other therapy available and evidence of progressive disease
             on study entry. Patients with stable disease will be included if there has been
             failure to respond to another drug(s) within the previous 3 months

        Exclusion Criteria:

          1. Patients with known liver metastases

          2. Radiation, chemotherapy, immunotherapy, any other systemic anticancer therapy or
             participation in an investigational anti-cancer study ≤ 3 weeks prior to initiation of
             therapy

          3. Patients with known brain metastasis

          4. Patients with any gastrointestinal dysfunctions that could interfere with the
             interpretation of the food effect data

          5. Patients with known intolerance to low or high fat meals

          6. In the opinion of the investigator, patients who are significantly below their ideal
             body weight
Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Motivational interviewing; Treatment as usual
Intervention description: Participants assigned to motivational interviewing will attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later. Motivational interviewing is a type of counselling. Each session is of approximately 1 hour duration.; Participants will continue with their normal treatment regimen as usual.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Dysthymia; Major Depression; Hispanics; Latinos; Motivational Interviewing; Adherence

Summary:

      This study will determine the effectiveness of motivational interviewing in improving
      antidepressant medication adherence among Hispanics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Self-identifies as Hispanic

          -  DSM-IV diagnosis of any unipolar depressive disorder (i.e., MDD, dysthymia, or
             depressive disorder not otherwise specified)

          -  Currently taking antidepressant medication

        Exclusion Criteria:

          -  Clinically significant suicidal ideation

          -  DSM-IV diagnosis of any substance-related disorder, bipolar disorder, or psychotic
             disorder/features within 12 months prior to study entry

          -  Unstable general medical condition
Pharmacokinetics of Ceftaroline in Subjects 12 to 17 Years of Age
Condition: Infection
Intervention: ceftaroline
Intervention description: Single parenteral infusion at a dose of 8 mg/kg for subjects weighing less than 75 kg or at a dose of 600 mg for subjects weighing greater than or equal to 75 kg infused over 60 minutes.
Intervention MeSH terms: Ceftaroline fosamil; Cephalosporins
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: PK; Pharmacokinetics

Summary:

      The purpose of this study is to determine the pharmacokinetics of ceftaroline in pediatric
      subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hospitalized and receiving antibiotic therapy for treatment of a suspected infection
             of any type

          -  Body mass index (weight [kg]/height squared [m2]) of no more than 30

          -  Males and females between 12 and 17 years of age, inclusive

        Exclusion Criteria:

          -  History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial

          -  Past or current history of epilepsy or seizure disorder

          -  Critically ill or unstable patients
Dose Finding Study of Vedolizumab for GvHD in Participants Undergoing Allogeneic HSCT
Condition: Allogeneic Hematopoietic Stem Cell Transplantation
Intervention: Vedolizumab
Intervention description: Vedolizumab Injection.
Intervention MeSH terms: Vedolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to assess the initial tolerability, safety and recommended phase
      2 dose of vedolizumab intravenous (IV) administered for GvHD prophylaxis along with standard
      GvHD prophylaxis therapy (in participants undergoing allogeneic hematopoietic stem cell
      transplantation [allo-HSCT]).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is undergoing matched or single-antigen mismatched unrelated-donor myeloablative
             transplant for the treatment of acute lymphoblastic leukemia (ALL) or acute myeloid
             leukemia (AML); Is less than or equal to (<=) 60 years of age.

             For the cohort after RP2D

          2. Is undergoing matched or single-antigen mismatched related or unrelated-donor
             transplant and receiving myeloablative conditioning or RIC for the treatment of
             hematologic malignancies or myeloproliferative neoplasms; Is less than or equal to
             (<=) 75 years of age.

        Exclusion Criteria:

          1. Has received prior allogeneic transplants or who are planned to undergo umbilical cord
             blood transplant, receive ex vivo T-cell-depleted hematopoietic stem cells (HSCs),
             received any in vivo T-cell depleting antibodies, or non-myeloablative conditioning.

          2. Has active cerebral/meningeal disease, active cytomegalovirus (CMV) colitis, or signs
             and symptoms of progressive multifocal leukoencephalopathy (PML) or any history of
             PML.

          3. Is undergoing transplant for the treatment of nonmalignant hematological disorders
             (for example: aplastic anemia, sickle cell anemia, thalassemias, Fanconi anemia).
Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants
Condition: Wilson Disease
MeSH terms: Hepatolenticular Degeneration
Intervention: ALXN1840; Bupropion Hydrochloride
Intervention description: ALXN1840 will be administered orally as a single dose as 4 x 15 mg enteric-coated tablets with 240 milliliters of water (fasting), for a total dose of 60 mg.; Bupropion hydrochloride will be administered orally as a single dose as one 150 milligrams (mg) tablet with 240 milliliters of water (fasting).
Intervention MeSH terms: Tetrathiomolybdate; Choline; Bupropion
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cytochrome P450; Healthy; ALXN1840

Summary:

      This is a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine
      the effect of ALXN1840 on the metabolism of bupropion, a sensitive cytochrome P450 2B6
      (CYP2B6) substrate, in healthy male and female participants. The safety and tolerability of
      ALXN1840 will be determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured
      via total molybdenum with the coadministration of bupropion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adequate venous access in the left or right arm to allow the collection of blood
             samples.

          -  Body weight ≥ 45 to ≤ 100 kilograms (kg) and body mass index within the range of 18 to
             < 30 kg/meter squared.

          -  Willing and able to follow protocol-specified contraception requirements.

          -  Capable of giving signed informed consent.

        Exclusion Criteria:

          -  History or presence of/significant medical history.

          -  Clinically significant multiple or severe allergies.

          -  Lymphoma, leukemia, or any malignancy within 5 years.

          -  Breast cancer within the past 10 years.

          -  Serum creatinine > upper limit of normal (ULN) of the reference range.

          -  Alanine aminotransferase, aspartate aminotransferase, or total bilirubin > ULN.

          -  Current or chronic history of liver disease or known hepatic or biliary abnormalities
             (with the exception of Gilbert's syndrome or asymptomatic gallstones).

          -  QTc > 450 milliseconds (msec) for male participants or > 470 msec for female
             participants.