bioihbjkbjnl/mcl2 huggingface dataset:
Study to Compare the Effects of Repeated Doses of an Investigational New Drug and a Placebo on Appetite in Advanced Cancer and Anorexia
Condition: Non-small Cell Lung Cancer; Pancreatic Cancer; Colorectal Cancer; Prostate Cancer; Breast Cancer; Ovarian Cancer; Loss of Appetite; Fatigue; Cachexia; Anorexia
MeSH terms: Wasting Syndrome; Fatigue; Anorexia; Cachexia
Intervention: PF-06946860; Placebo for PF-06946860
Intervention description: subcutaneous injection; subcutaneous injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double-blind, sponsor open for 6-week double-blind treatment period followed by an optional 18-week open-label treatment period.
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue

Summary:

      Study to compare the effects of the investigational new drug (PF-06946860) and a placebo on
      appetite and to find out how participants with advanced cancer and anorexia feel after
      receiving repeated subcutaneous (SC-injected under the skin) doses.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Documented diagnosis of non-small cell lung, pancreatic, colorectal, prostate, breast
             or ovarian cancer which, in the treating oncologist's assessment, is considered
             advanced.

          -  Anorexia as defined by a score of ≤5 in the Cancer-Related Cachexia Symptom Assessment
             Appetite 7-day recall scale

          -  Meets any of the following criteria at Randomization:

               -  Not currently receiving antineoplastic therapy

               -  On standard of care systemic antineoplastic therapy or treatment without curative
                  intent

          -  Signed informed consent.

        Key Exclusion Criteria:

          -  Receiving tube feedings or parenteral nutrition at the time of Screening or
             Randomization.

          -  Current active reversible causes of decreased food intake.

          -  Current, severe gastrointestinal disease

          -  Participants with known symptomatic brain metastases requiring steroids.

          -  Active uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, HIV or
             participants with known AIDS-related illness

          -  inadequate renal or liver function.

          -  Women who are pregnant or breast-feeding
Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia
Condition: Hemophilia A; Hemophilia B; Hemophilia A With Inhibitor; Hemophilia B With Inhibitor; Hemophilia A Without Inhibitor; Hemophilia B Without Inhibitor
MeSH terms: Hemophilia A; Hemophilia B
Intervention: MarzAA (marzeptacog alfa [activated])
Intervention description: Single intravenous dose and ascending doses of subcutaneous injection of MarzAA (Coagulation Faction VIIa Variant)
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multi-center, open label Phase 1 study will evaluate the pharmacokinetics,
      pharmacodynamics, and safety of a single IV dose of MarzAA followed by ascending single SC
      doses of MarzAA in adult subjects with moderate or severe Hemophilia A or B, with or without
      an inhibitor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate or severe congenital Hemophilia A or B, with or without an inhibitor

          -  Male, age 18 or older

          -  Affirmation of informed consent with signature confirmation before any trial related
             activities

        Exclusion Criteria:

          -  Inability to discontinue and washout prophylaxis treatment 72 hours prior to dosing.

          -  Previous participation in a trial involving SC Administration of rFVIIa or any trial
             using a modified amino-acid sequence FVIIa

          -  Known positive antibody to FVII or FVIIa detected by central laboratory at screening

          -  Have a coagulation disorder other than hemophilia A or B, with or without an inhibitor

          -  Significant contraindication to participate
Phase 1 Study to Evaluate the Effect of DS-8201a on the QT/QTc Interval and Pharmacokinetics in HER2-Expressing Breast Cancer
Condition: Malignant Neoplasm of Breast
MeSH terms: Breast Neoplasms; Neoplasms
Intervention: DS-8201a
Intervention description: DS-8201a is supplied as a lyophilized powder which is reconstituted for infusion
Intervention MeSH terms: Trastuzumab deruxtecan
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: HER2; Breast cancer; Oncology; Antibody drug conjugate; ADC

Summary:

      This study will look at the effect on the QTc interval and pharmacokinetics after multiple
      dosing in subjects with HER2-expressing metastatic and/or unresectable breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a pathologically documented unresectable or metastatic breast cancer with HER2
             expression (immunohistochemistry [IHC] 3+, IHC 2+, IHC 1+ and/or in situ hybridization
             [ISH] +) that is refractory to or intolerable with standard treatment, or for which no
             standard treatment is available

          -  Has a left ventricular ejection fraction (LVEF) ≥ 50%

          -  Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1

        Exclusion Criteria:

          -  Has a medical history of myocardial infarction within 6 months before enrollment

          -  Has a medical history of ventricular arrhythmias, other than rare occasional premature
             ventricular contractions

          -  Has uncontrolled or significant cardiovascular disease
First in Human Study of RVP-001, a New Manganese Based MRI Contrast Agent
Condition: Healthy
Intervention: RVP-001; Placebo
Intervention description: Intravenous administration of RVP-001; Intravenous administration of saline placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objectives of this trial are:

        1. To evaluate the safety and tolerability of single ascending doses of RVP-001 in healthy
           adult volunteers

        2. To determine the pharmacokinetics and elimination of RVP-001 in healthy adult
           volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects

          2. Healthy subjects aged 18 to 55 years inclusive

          3. Suitable veins for phlebotomy, cannulation, or repeated venipuncture

          4. Have a body mass index between 18 and 32 kg/m^2 (inclusive); weigh at least 55 kg.

          5. Appropriately completed written informed consent prior to any study specific
             procedures.

        Exclusion Criteria:

          1. Any clinically significant abnormality or abnormal laboratory test results found
             during medical screening

          2. Vital sign abnormalities at screening or admission

          3. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory
             or gastrointestinal disease; neurological or psychiatric disorder, as judged by the
             investigator

          4. Positive pregnancy test at screening or admission

          5. History of alcohol abuse

          6. History of drug abuse

          7. Use of nicotine-containing products within 12 months of study start

          8. Use of medication except topical products without significant systemic absorption

          9. Known allergies to any component of RVP-001

         10. Subjects who have received any investigational product (IP) in a clinical research
             study within 5 IP half-lives or 30 days prior to first dose.

         11. Donation of plasma within 7 days prior to dosing; significant donation or loss of
             blood within 30 days prior to the first dosing.

         12. Any reason which, in the opinion of the Principal Investigator, would prevent the
             subject from participating in the study.
Utilization of Confocal Microscopy During Cardiac Surgery
Condition: Atrial Septal Defect
MeSH terms: Heart Septal Defects, Atrial
Intervention: Fluorescite; Cellvizio 100 Series System with Confocal Miniprobes
Intervention description: Dilute fluorescite will be applied to cardiac tissue prior to imaging; Microscopy system will image cardiac tissue.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 30 Days
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      The investigators propose to translate confocal microscopy for use during open heart surgery.
      This tool will help discriminate between various types of tissues in the heart during
      surgery. One of the most feared complication after heart surgery is heart block. This
      flexible fiberoptic confocal microscope will help discriminate between the various types of
      tissues in the heart and thus help avoid injury to the conduction tissue during surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females between 30 days and 21 years old

          -  Undergoing elective surgery for closure of atrial septal defect

          -  Both parents attend pre-operative clinic appointment, to provide 2 parent consent, or
             an adult participant (age 18-21) may provide consent for him/herself

        Exclusion Criteria:

          -  Prior history of adverse reaction to fluorescein sodium

          -  Prior history of renal failure or abnormal renal function

          -  Baseline PR interval > 220 msec or 98% for age

          -  Baseline HR > 87% for age

          -  Underlying genetic syndrome associated with progressive AV block of sinus node
             dysfunction (e.g. Holt-Oram or NKX2.5)
A Hepatic Impairment Study for PF-04965842.
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Intervention: PF-04965842
Intervention description: PF 04965842 is an orally bioavailable small molecule that selectively inhibits JAK1.
Intervention MeSH terms: Abrocitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Parallel Assignment
Intervention model description: Recruitment for subjects with moderate and mild hepatic impairment (Cohorts 1 and 2) will initiate first and these subjects will be enrolled in parallel.
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 1 non randomized, open label, single dose, parallel cohort study to
      investigate the effect of hepatic impairment on the PK, safety and tolerability of PF
      04965842.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110
             pounds).

          -  Subjects who are willing and able to comply with all scheduled visits, treatment plan,
             laboratory tests, and other study procedures.

        Additional Inclusion Criteria for subjects with hepatic impairment:

          -  Satisfy the criteria for Class A or Class B of the Child Pugh classification (mild:
             Child Pugh Scores 5 to 6 points, and moderate: Child Pugh Scores 7 to 9 points),
             within 14 days of investigational product administration.

          -  A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to
             any acute ongoing hepatocellular process) documented by medical history, physical
             examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or
             magnetic resonance imaging (MRI).

        Exclusion Criteria:

          -  Subjects with clinically significant infections within the past 3 months (for example,
             those requiring hospitalization, or as judged by the Investigator), evidence of any
             infection (including influenza) within the past 7 days, history of disseminated herpes
             simplex infection or recurrent (>1 episode) or disseminated herpes zoster.

          -  Subjects with a malignancy or with a history of malignancy, with the exception of
             adequately treated or excised non metastatic basal cell or squamous cell cancer of the
             skin or cervical carcinoma in situ.

        Additional exclusion criteria for subjects with hepatic impairment:

          -  Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy
             (defined as less than 1 year).

          -  Subjects who have previously had a transplanted kidney, liver, or heart.

          -  At Screening, persistent severe, uncontrolled hypertension.
Monoclonal Antibody Therapy in Treating Patients Scheduled for Surgery to Remove Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Monoclonal antibody hu3S193
Intervention description: Hu3S193 was to be administered intraperitoneally or intravenously at a dose of 5mg. Doses of hu3S193 were radiolabeled with 5 mCi of 111In.
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ovarian epithelial cancer

Summary:

      RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
      tumor-killing substances to them without harming normal cells. Giving monoclonal antibodies
      in different ways may kill more tumor cells.

      PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating
      patients who have ovarian cancer.
    

Eligibility criteria:

        Inclusion Criteria

        Cytologic or pathologic diagnosis consistent with ovarian carcinoma. Scheduled to undergo
        surgical evaluation. Karnofsky performance status of > 60%.

        Adequate organ function as defined by:

          -  Absolute neutrophil count (ANC) > 1.5 x 10^9/L

          -  Platelet count > 100 x 10^9/L

          -  Bilirubin < 2.0 mg/dL

          -  Aspartate aminotransferase (AST) and Alanine transaminase (ALT) < 2.5 X upper limit of
             normal

          -  Serum creatinine < 2.0 mg/dL

          -  Forced expiratory volume at one second (FEV1) and forced vital capacity (FVC)> 70% of
             predicted

          -  Left Ventricular Ejection Fraction >50%

        Recovered from the toxicity of any prior therapy. No evidence of active infection which
        requires antibiotic therapy. > 18 years of age. Able to sign written informed consent.

        Exclusion Criteria

        Any significant intercurrent medical problems which may limit the amount of antibody they
        can tolerate, or render them ineligible for surgery.

        Clinically significant cardiac disease (New York Heart Association Class III/IV, or
        abnormalities on ECG that are considered by the investigator to place the patient at
        increased risk), severe debilitating pulmonary disease, active infections or coagulation
        disorders.

        Survival expectancy less than 12 weeks. History of autoimmune hepatitis or history of
        autoimmune disease. Chemotherapy, radiotherapy, or immunotherapy within four weeks prior to
        receiving hu3S193.

        Psychiatric, addictive or other disorders that compromise the ability to give informed
        consent.
A Study of Ramucirumab (LY3009806) in Healthy Participants
Condition: Healthy
Intervention: Ramucirumab - IV; Placebo - IV; Ramucirumab - SC; Placebo - SC
Intervention description: Administered IV.; Administered IV.; Administered SC.; Administered SC.
Intervention MeSH terms: Ramucirumab; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluates a new formulation of ramucirumab, a drug approved for several types of
      cancer.

      In this study of healthy participants, a small amount of ramucirumab will be given by
      injection either into a vein or just under the skin. Study doctors will measure the amount of
      ramucirumab in the bloodstream.

      Side effects and tolerability will be documented. The study will last for about 16 weeks for
      each participant, including screening and follow up. Screening is required within 28 days
      prior to entering the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy male or a female (not pregnant and agreeable to take birth control
             measures until study completion)

          -  Have a body weight greater than or equal to (≥)70 kilograms (kg) and body mass index
             (BMI) of 18 to 32 kilogram per square meter (kg/m ²), inclusive

          -  Have normal blood pressure, pulse rate, electrocardiogram (ECG), and blood and urine
             laboratory test results that are acceptable for the study

        Exclusion Criteria:

          -  Are currently participating in or completed a clinical trial within the last 30 days
             or any other type of medical research judged to be incompatible with this study

          -  Have previously participated or withdrawn from this study

          -  Have or used to have health problems or laboratory test results or ECG readings that,
             in the opinion of the doctor, could make it unsafe to participate, or could interfere
             with understanding the results of the study

          -  Had blood loss of more than 500 milliliters (mL) within the previous 30 days of study
             screening
Staccato Alprazolam Abuse Liability
Condition: Abuse Liability of Staccato Alprazolam
Intervention: Inhaled placebo + oral placebo; Inhaled alprazolam 0.5 mg; Inhaled alprazolam 1 mg; Inhaled alprazolam 2 mg; Oral alprazolam 1 mg; Oral alprazolam 2 mg; Oral alprazolam 4 m; Oral alprazolam 2 mg qualifying session; Oral placebo qualifying session
Intervention description: Inhaled Staccato placebo + oral placebo; Inhaled Staccato alprazolam 0.5 mg + oral placebo; Inhaled Staccato alprazolam 1 mg + oral placebo; Inhaled Staccato alprazolam 2 mg + oral placebo; Oral alprazolam 1 mg + Inhaled placebo; Oral alprazolam 2 mg + Inhaled placebo; Oral alprazolam 4 mg + Inhaled placebo; Qualifying session (2 mg oral alprazolam); Qualifying control session (oral placebo)
Intervention MeSH terms: Alprazolam
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The crossover schedule is planned according to a 7-treatment, 7-period Latin Square design due to E.J. Williams (1949), which is balanced for first-order carryover effects (Fleiss, 1986). Each subject will receive all treatments in this 7-treatment, 7- period Williams Square crossover design as suggested by Chen & Tsong (2007). This Williams Square will include one replication by 1 subject of each of the 14 sequences
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: In order to reduce discrimination between placebo and active Staccato Alprazolam, taste blinding will be accomplished using a rapidly dissolving, intensely flavored product (candy, strip or breath spray). The product will be administered immediately after each oral capsule dosing (at the -60-min and 0- min time points).
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Compare the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and
      Staccato Placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects between the ages of 18 to 55 years, inclusive, who have a
             history of substance abuse or dependence on barbiturates and/or benzodiazepine
             receptor agonists for their intoxicating effects

        Exclusion Criteria:

          -  Subjects with a significant current psychiatric illness or taking any psychotropic
             prescription medications for therapeutic uses.
Glutamate Reducing Interventions in Schizophrenia
Condition: Clinical High Risk for Psychosis
MeSH terms: Schizophrenia
Intervention: Pomaglumetad methionil
Intervention description: metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, randomized, phase 1b, multiple dose trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Identity of medications will be blinded having every subject take an equal number of pills (using identical looking tables of placebo)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: No

Summary:

      Participants will be administered several doses of pomaglumetad (POMA) (low and high doses)
      over 14 days to individuals at clinical high risk for developing psychosis and use magnetic
      resonance imaging (MRI) brain imaging to determine whether these doses of POMA are affecting
      glutamate levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Capacity to provide informed consent

          -  Currently using a reliable form of birth control

        Exclusion Criteria:

          -  Metal implants in body or a history of metal working

          -  Lifetime diagnosis of asthmatic symptoms within the past 3 years or known sensitivity
             to contrast agents

          -  Lifetime diagnosis of renal failure/disease

          -  Acute neurological, neuroendocrine, or medical disorder including renal insufficiency
             (CrCl<40 mL/min/1.73m2)

          -  Lifetime diagnosis of hypertension or diabetes or seizure disorder

          -  IQ<70

          -  Acute risk for suicide and/or violence

          -  Pregnant lactating

          -  Current abuse of substances (alcohol, cocaine, stimulants, cannabis, opiates, sedative
             hypnotics)

          -  Current use or anticipated need for antipsychotics or mood stabilizers (all
             antipsychotics, also depakote, lithium, lamotrogine, pregabalin or any med with a
             mechanism of action like gabapentin), probenecid, selective serotonin reuptake
             inhibitors, tricyclic antidepressants, and monoamine oxidase inhibitors

          -  More than one previous gadolinium scan