bioihbjkbjnl/mcl2 huggingface dataset:
A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients
Condition: Myelodysplastic Syndrome; Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Myelodysplastic Syndromes
Intervention: PF-04449913 (Glasdegib); Azacitidine
Intervention description: Daily dose of PF-04449913 100mg tablet in a continuous regimen of 28 day cycles; 75mg/m2 on Days 1-7 (+/- 3 days for each dose) of a 28 day cycle
Intervention MeSH terms: Azacitidine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MDS; AML; CMML

Summary:

      This multi center open label Phase 1b study is designed to evaluate the safety, efficacy,
      pharmacokinetics (PK), and pharmacodynamics (PD) of glasdegib (PF-04449913) when combined
      with azacitidine in patients with previously untreated Higher Risk Myelodysplastic Syndrome
      (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML). This clinical
      study includes two components: (a) a safety lead in cohort (LIC) and (b) an expansion phase
      with an AML cohort and an MDS cohort.
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients must have previously untreated MDS, AML, or CMML according to the WHO 2016
             classification.

          -  MDS patients must have Intermediate (>3 to 4.5 points), High Risk (>4.5 - 6) or Very
             High Risk (>6 points) disease according to the Revised International Prognostic
             Scoring System 2012 (IPSS-R).

          -  Clinical indication for treatment with azacitidine for MDS or AML.

        Exclusion criteria:

          -  Patients with AML who are candidates for standard induction chemotherapy as first line
             treatment.

          -  Patients with known active CNS leukemia.

          -  Prior treatment with a smoothened inhibitor (SMOi) and/or hypomethylating agent.
A Study to Evaluate the Effect of the Potent Cytochrome P-450 3A4 (CYP3A4) Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-954 in Healthy Adult Participants
Condition: Healthy Participants
Intervention: TAK-954; Itraconazole
Intervention description: TAK-954 Infusion; Itraconazole Capsule
Intervention MeSH terms: Itraconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the effect of the potent CYP3A4 inhibitor
      itraconazole on the single-dose PK of TAK-954.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a man or woman (with no child bearing potential) aged 18 to 55 years, inclusive, at
             the Screening Visit.

          2. Has a body mass index (BMI) from greater than or equal to (>=) 18 and less than or
             equal to (<=) 30 kilogram per square meter (kg/m^2) and has a body weight greater than
             (>) 50 kilogram (kg) at the Screening Visit.

          3. Is a nonsmoker who has not used tobacco- or nicotine-containing products (example,
             nicotine patch) for at least 6 months before administration of the initial dose of
             trial drug/invasive procedure.

        Exclusion Criteria:

          1. Has a positive alcohol or drug screen.

          2. Had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter (mL))
             within 8 weeks of the first dose of study drug.

          3. Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1
             glass is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces],
             or distilled spirits [29.5 mL/1 ounce] per day).

          4. Consumes excessive amounts, defined as greater than 6 servings (1 serving is
             approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks,
             or other caffeinated beverages per day.

          5. Has a substance abuse disorder.
Study of Pembrolizumab (MK-3475) in Participants With Advanced Non-small Cell Lung Cancer (MK-3475-025/KEYNOTE-025)
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pembrolizumab
Intervention description: Intravenous infusion
Intervention MeSH terms: Pembrolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: PD1; PD-1; PDL1; PD-L1

Summary:

      This study is being done to evaluate the safety and efficacy of pembrolizumab (MK-3475) in
      participants with advanced non-small cell lung cancer (NSCLC) tumors that are positive for
      programmed cell death ligand 1 (PD-L1): the hypothesis is that treatment with pembrolizumab
      will result in a clinically meaningful Overall Response Rate (ORR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of non-small cell lung cancer
             (NSCLC) that is PD-L1 positive per central laboratory review

          -  At least one measurable lesion

          -  Radiographic progression of NSCLC after treatment with a platinum-containing doublet
             for Stage IIIB/IV or recurrent disease

          -  Eastern Cooperative Oncology Group (ECOG) Performance Scale 0 or 1

          -  Adequate organ function

        Exclusion Criteria:

          -  Systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks
             of the first dose of trial treatment

          -  Systemic steroid therapy within 3 days prior to the first dose of trial treatment or
             any other form of immunosuppressive medication

          -  Expected to require any other form of systemic or localized antineoplastic therapy
             while on trial

          -  History of prior malignancy, with the exception of basal cell carcinoma of the skin,
             superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cancer

          -  Active central nervous system (CNS) metastases and/or carcinomatous meningitis

          -  Active autoimmune disease or documented history of autoimmune disease or syndrome that
             requires systemic steroids or immunosuppressive agents

          -  Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic
             T-lymphocyte-associated antigen-4 (CTLA-4) antibody

          -  Concurrent or past history of interstitial lung disease

          -  Pregnant or breast-feeding, or expecting to conceive or father children within the
             projected duration of the study, starting with screening visit through 120 days after
             the last dose of pembrolizumab
Renal Impairment Study of PF-06700841
Condition: Healthy Volunteer; Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: PF-06700841
Intervention description: A single dose of 30 mg PF-06700841 will be administered on Day 1
Intervention MeSH terms: PF-06700841
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Single group
Masking: None (Open Label)
Masking description: No Masking
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics

Summary:

      The purpose of this study is to characterize the effect of kidney impairment on the blood
      concentrations of PF-06700841 and its major metabolite. Findings from this study will be used
      to develop dosing recommendations so that the dose and/or dosing interval may be adjusted
      appropriately in the presence of kidney disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants who are between the ages of 18 and 75 years, inclusive, at
             the Screening visit.

          -  Body mass index (BMI) of ≥17.5 to ≤40 kg/m2; and a total body weight >50 kg.

          -  Normal, Severe, Moderate and Mild renal function at 2 Screening visits.

          -  Stable drug regimen

        Exclusion Criteria:

          -  Renal transplant recipients.

          -  Urinary incontinence without catheterization.

          -  Subjects with clinically significant infections within the past 6 months prior to
             first dose of study drug, evidence of active or chronic infection requiring oral
             treatment within 4 weeks prior to first dose

          -  Known history of pulmonary embolism or recurrent deep vein thrombosis

          -  Any condition possibly affecting drug absorption (eg, prior bariatric surgery,
             gastrectomy, ileal resection).
A Study of Galcanezumab in Healthy Participants
Condition: Healthy
Intervention: Galcanezumab; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purposes of this study are:

        -  To evaluate tolerability of the Galcanezumab solution injectable formulation (Part A)

        -  To measure how much of the Galcanezumab lyophilized (freeze dried) injectable
           formulation is absorbed into the blood stream and how long it takes the body to get rid
           of it compared to the Galcanezumab solution injectable formulation after a single
           injection under the skin (subcutaneous [SC]) (Part B).

      Information about any side effects that may occur will also be collected. Each part of the
      study will last about six months. Participants may only enroll in one part.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female healthy participants

          -  Have a body mass index of 19.0 to 35.0 kilograms per meter square (kg/m²), inclusive

        Exclusion Criteria:

        - Currently smoke in excess of 5 cigarettes/day
Oral Abuse Potential Study of Nalbuphine
Condition: Nalbuphine; Opioid Abuse
MeSH terms: Opioid-Related Disorders
Intervention: Nalbuphine HCl solution; Placebo solution
Intervention description: nalbuphine solution administered at various strengths; Placebo
Intervention MeSH terms: Nalbuphine; Pharmaceutical Solutions
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-dose, randomized, double-blind, active- and placebo-controlled, double-dummy, 2-part, 7-way crossover study.
Part A: Dose selection phase Part B: Treatment Periods 1-7
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: For each dosing cohort, an unblinded statistician, not otherwise involved in the study, will prepare a list of subject randomization numbers. These randomization numbers will be used to prepare individual subject doses. Sealed qualification code break envelopes will be available for each subject in case of emergency.
Upon completion of each cohort of subjects, the randomization codes for the completed subjects will be unblinded by the CRU pharmacy. After unblinding, the safety data will be reviewed to determine if dosing can proceed for the next planned dosing cohort,
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: nalbuphine; abuse potential

Summary:

      The purpose of this study is to measure the effects of a drug called nalbuphine (an opioid
      drug) compared with the effects of hydromorphone (an opioid drug) and placebo (contains no
      active drug ingredients). The amount of nalbuphine levels in the blood will also be measured
      and the safety of the study drugs will be evaluated.

      This study has 2 parts: Part A and Part B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female subjects 18 to 55 years of age

          -  Current opioid users who have used opioids for recreational (non-therapeutic) purposes

        Exclusion Criteria:

          -  Self-reported substance or alcohol dependence (excluding nicotine and caffeine)

          -  Heavy smoker (≥ 20 cigarettes per day) and/or who is unable to abstain from smoking
             for at least 8 hours during the in clinic periods.

          -  History or presence of clinically significant abnormality as assessed by physical
             examination, medical history, ECGs, vital signs, or laboratory values.

          -  History or presence of any clinically significant illness

          -  History of major mental illness that may affect the ability of the subject to
             participate in the study.
Differential Responses to Drugs and Sweet Tastes
Condition: Bipolar II Disorder
Intervention: Placebo oral capsule; d-amphetamine 10 mg oral capsule; d-amphetamine 20 mg oral capsule
Intervention description: Placebo oral capsule; d-amphetamine 10 mg oral capsule; d-amphetamine 20 mg oral capsule
Intervention MeSH terms: Amphetamine; Dextroamphetamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study will track participants in two assigned groups (participants that exhibit either High or Low Bipolar II/Hypomanic phenotypes)
Masking: Double (Participant, Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Maximum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Young adults who exhibit "bipolar phenotype" (BPP), defined as occasional episodes of mood
      elevation and heightened activity, are at risk for several psychiatric disorders, including
      problem use of drugs and alcohol. Mood elevation has been linked to higher alcohol
      consumption and alcohol use disorders. Individuals with BPP show elevated lifetime prevalence
      of alcohol use disorders (between 39%-61%), figures that exceed those reported in both major
      depression and schizophrenia. Recently, the investigators demonstrated in a controlled
      laboratory study that individuals with BPP (but not meeting criteria for full Bipolar I
      Disorder), report dampened responses to a single dose of alcohol, compared to placebo. In the
      current study, the investigators seek to extend these findings to determine if young adults
      reporting BPP, based on a questionnaire, will exhibit reduced responses to other rewarding
      stimuli, such as d-amphetamine and sweet tastes. The investigators hypothesize that the BPP
      individuals will exhibit dampened subjective responses to stimulant and sweet taste rewards
      compared to healthy controls.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18-19 years old

          -  BMI of 19-26

          -  Physical/EKG/Medical History/Medications Approved by Physician for d-amphetamine

          -  at least High School education

          -  Fluent in English

        Exclusion Criteria:

          -  No Current Mood, Anxiety, Eating or Psychotic Disorder

          -  No current psychotropic medication

          -  No Recent Drug Dependence

          -  < 4 alcoholic drinks/day for males; < 3 alcoholic drinks/day for females (monthly
             average)

          -  No weekly (or more frequent) illicit drug use

          -  No women who are pregnant, nursing, or planning pregnancy within 3 months (birth
             control is okay)
Effect of Stimulant Drugs on Social Perception
Condition: Healthy; MDMA ('Ecstasy')
Intervention: 3,4-Methylenedioxymethamphetamine; methamphetamine
Intervention description: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA; Please see above.
Intervention MeSH terms: Methamphetamine; N-Methyl-3,4-methylenedioxyamphetamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study will improve our understanding of the "prosocial" effects of ±
      3,4-Methylenedioxymethamphetamine (MDMA), relative to a prototypical stimulant,
      methamphetamine (MA). The investigators seek to characterize the "uniquely social" effects of
      MDMA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  High school degree

          -  English fluency

          -  Healthy

          -  Has used MDMA

        Exclusion Criteria:

          -  Pregnant or trying to become pregnant

          -  Any medical or psychiatry condition
Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Intervention: PF-07321332; Ritonavir
Intervention description: Tablet; PK Boosting agent
Intervention MeSH terms: Ritonavir; Nirmatrelvir
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COVID-19; SARS-CoV-2

Summary:

      The study is to estimate the effect of hepatic impairment on the plasma PK of
      PF-07321332/ritonavir. Findings from this study will be used to develop dosing
      recommendations so that the dose and/or dosing interval may be adjusted appropriately in the
      presence of hepatic impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants who are classically healthy having no clinically relevant
             abnormalities. No known or suspected hepatic impairment

          -  Stable hepatic impairment that meets the criteria for Class B of the Child-Pugh
             Classification

        Exclusion Criteria:

          -  Any condition possibly affecting drug absorption (eg, prior bariatric surgery,
             gastrectomy, ileal resection).

          -  Participants who have been vaccinated with COVID-19 vaccines within the past week of
             dosing

          -  A positive urine drug test, for illicit drugs, at Screening

          -  History of sensitivity reactions to ritonavir or any of the formulation components of
             PF-07321332 or ritonavir.

          -  eGFR <60 mL/min/1.73m2 based on the Chronic Kidney Disease-Epidemiology Collaboration
             (CKD-EPI) equation

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥ upper limit
             of normal (ULN) (for healthy participants); AST or ALT > 5x ULN (for hepatic
             impairment participants)

          -  Albumin > ULN (for healthy participants);

          -  Prothrombin time > ULN (for healthy participants);

          -  Total bilirubin level ≥1.5 × ULN [NOTE: Participants with a history of Gilbert
             syndrome (and hence elevated total bilirubin) are eligible provided direct bilirubin
             level is ≤ ULN).
A Phase I Clinical Study With Investigational Compound LTT462 in Adult Patients With Specific Advanced Cancers.
Condition: Ovarian Neoplasms; Non-Small-Cell Lung Carcinoma; Melanoma; Other Solid Tumors
MeSH terms: Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms
Intervention: LTT462
Intervention description: ERK Inhibitor
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: LTT462; ERK; MAPK; solid tumor

Summary:

      A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway
      alterations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient (male or female) ≥12 years of age

          -  ECOG (Eastern Cooperative Oncology Group) performance status ≤1

          -  Must have progressed following standard therapy, or for whom, in the opinion of the
             Investigator, no effective standard therapy exists, is tolerated or appropriate.

          -  Patients must be willing and able to undergo study required biopsies.

          -  Presence of at least one measurable lesion according to RECIST v1.1.

          -  Documented MAPK pathway alteration

        Exclusion Criteria:

          -  Prior treatment with ERK inhibitors.

          -  History or current evidence of retinal vein occlusion (RVO) or current risk factors
             for RVO.

          -  Any medical condition that would, in the investigator's judgment, prevent the
             patient's participation in the clinical study due to safety concerns or compliance
             with clinical study procedures.

          -  Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days
             prior to the start study treatment and for the duration of the study.

          -  Patients with malignant disease other than that being treated in the study.

          -  Clinically significant cardiac disease.

        Other protocol-defined exclusion criteria may apply.
A Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of KA34 in Subjects With Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: KA34; Placebo
Intervention description: 50 µg - 400 µg intra-articular injection (single or multiple doses); 50 µg - 400 µg intra-articular injection (single or multiple doses)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Arthritis; Joint Disease; Osteoarthritis, Knee

Summary:

      This study will evaluate the safety and tolerability of KA34 when administered via
      intra-articular injection to subjects with osteoarthritis of the knee.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of localized osteoarthritis of the knee

          -  Males willing to use contraception and females who are no longer able to bear children

        Exclusion Criteria:

          -  Body Mass Index (BMI) > 40

          -  Grade 0, 3 or 4 osteoarthritis on the Kellgren and Lawrence classification system

          -  Injury to the knee or other joint within the last 12 months

          -  Receipt of any investigational product or experimental therapeutic procedure within
             the last 12 weeks