bioihbjkbjnl/mcl2 huggingface dataset:
An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma.
Condition: Lymphoma, Mantle-Cell
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell
Intervention: PD-0332991
Intervention description: 125 mg, oral, Days 1-21 of a 28-day cycle
Intervention MeSH terms: Palbociclib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This is a pilot study evaluating tumor activity using Positron Emission Tomography, which is
      also known as a "PET scan". This study will assess the safety of using PD-0332991 in patients
      with mantle cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented MCL.

          -  Must have received at least one prior therapy.

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤1.

          -  Adequate organ function as outlined in the protocol.

        Exclusion Criteria:

          -  Major surgery, radiation therapy, or systemic therapy within 4 weeks of study
             enrollment.

          -  Prior radiation therapy to >25% of the bone marrow (whole pelvis is 25%).

          -  Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or
             leptomeningeal disease.
Safety, Tolerability, and Pharmacokinetics of Escalating Single Doses of TAK-935
Condition: Healthy Volunteers
Intervention: TAK-935; Placebo
Intervention description: TAK-935 oral solution; TAK-935 placebo-matching oral solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to characterize the safety and tolerability profile of TAK-935
      in healthy participants when administered as a single dose of oral solution at escalating
      dose levels.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a healthy male or female adult who is 19 to 55 years of age inclusive at the time
             of informed consent.

          2. Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m^2,
             inclusive at the Screening Visit.

        Exclusion Criteria:

          1. Has uncontrolled, clinically significant neurological (including seizure disorders),
             cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological,
             immunologic, endocrine disease, or psychiatric disorder, or other abnormality.

          2. Has a known hypersensitivity to any component of the formulation of TAK-935.

          3. There is any finding in the participant's medical history, significant results from
             physical examination, or safety laboratory tests.
QT Intervals Study to Compare the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo
Condition: Healthy
Intervention: MAP0004; Inhaler Placebo; Moxifloxacin; Placebo Capsule
Intervention description: 3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol; Placebo for Inhaler administered in Treatments A and C; 400mg encapsulated tablet administered in Treatment A as per protocol; Placebo for Moxifloxacin administered in Treatment B and Treatment C
Intervention MeSH terms: Moxifloxacin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Volunteers

Summary:

      Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered
      by Oral Inhalation) with Moxifloxacin and Placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Able to provide a signed, executed written informed consent

          2. Healthy non-smoking adult volunteers: Male or Female subjects 18 to 45 years old

          3. Female subjects who are practicing adequate contraception (see section 4.4) or who are
             sterile

          4. No known cardiac disease

          5. Normal hemoglobin values

          6. Normal or not clinically significant 12-lead Electrocardiogram

               -  Heart rate ≥ 40 and ≤ 100 at Visit 1 vital signs assessment (resting)

               -  Subjects with QTcF interval duration <430 msec for males and <450 msec for
                  females obtained from the ECG recorder's measurements on the screening ECG taken
                  after at least 5 minutes of quiet rest in supine position

          7. Demonstrated ability to properly use the Tempo® Inhaler

          8. Subject has not donated blood in the last 56 days

        Exclusion Criteria:

          1. Contraindication to dihydroergotamine mesylate (DHE)

          2. History of hemiplegic or basilar migraine

          3. Family history of long QT syndrome

          4. Participation in another investigational trial during the 30 days prior to Visit 1
Safety Study of OPC-12759 Ophthalmic Solution
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes
Intervention: OPC-12759 Ophthalmic solution; OPC-12759 Ophthalmic suspension
Intervention description: 2％ OPC-12759 Ophthalmic solution; 2％ OPC-12759 Ophthalmic suspension
Intervention MeSH terms: Rebamipide; Ophthalmic Solutions
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the safety of OPC-12759 ophthalmic solution in healthy
      subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI : {body weight (kg) / [height (m)] 2 } must be 17.6 or greater, and less than 26.4
             kg/m2

        Exclusion Criteria:

          1. Presence of ocular disorder

          2. Intraocular pressure of 21mmHg or higher

          3. Corrected visual acuity of less than 1.0

          4. Dysfunction of nasolacrimal duct or history of surgery related to nasolacrimal duct or
             eye lid which affects the nasolacrimal outflow

          5. History of refractive surgery

          6. History of other ocular surgeries within 12 months

          7. Those who cannot discontinue the use of contact lenses from the 1st dose to
             5-hour-post-dose
Telephone Counseling: Men With Prostate Cancer & Partners
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Telephone Interpersonal Counseling; Telephone delivered education only
Intervention description: Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy.; Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 79.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Psychosocial Intervention; Men with Prostate Cancer & Partners

Summary:

      The purpose of this project is to test a telephone delivered educational support program
      versus an education only program for improving symptom management and quality of life in men
      with prostate cancer and their partners.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Receiving treatment for prostate cancer

          -  Over 21 years

          -  Access to and ability to talk on the phone

          -  Speaks English and has a partner to participate with him.

          -  Partners are anyone who the man chooses (friend or relative) who is over 21 years,
             English speaking and has access and ability to talk on the phone.

        Exclusion Criteria:

          -  under 21 years

          -  Does not speak English
Performance and Safety Evaluation of an Intradermal Delivery Device
Condition: Injections, Intradermal
Intervention: PATH ID Adapter
Intervention description: Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Intradermal injections; Vaccination

Summary:

      The purpose of this study is to evaluate whether an investigational vaccine delivery device
      (the ID adapter) can safely and precisely inject liquid into the intradermal layer of the
      skin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female and male participants ages 18 to 55 years.

          -  Healthy enough to participate in the clinical trial per site investigator assessment.

          -  Healthy skin on the upper deltoid region of both arms.

          -  Able to provide signed informed consent and understand study procedures per ICH/GCP
             guidelines.

          -  Literate in English.

          -  Available by telephone 48 hours after the study visit.

        Exclusion Criteria:

          -  Skin abnormalities on upper deltoid region of either arm (scars, rash, infection) or
             other skin conditions that would interfere with the ability to visualize an
             intradermal injection in the opinion of the investigator.

          -  Unable to understand the study purpose or procedures.
Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
Condition: HCV Infection
MeSH terms: Hepatitis C
Intervention: Voxilaprevir
Intervention description: 100 mg tablet administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to evaluate the pharmacokinetics (PK), safety, and
      tolerability of a single dose of voxilaprevir (formerly GS-9857) in participants with normal
      hepatic function, moderate hepatic impairment and severe hepatic impairment. Participants in
      the healthy control group will be matched to participants with impaired hepatic function by
      gender, age (± 10 years), and body mass index (± 15%).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  All individuals:

               -  Screening laboratory values within defined thresholds for group

               -  Use of two effective contraception methods if female of childbearing potential or
                  sexually active male

          -  For individuals with moderate hepatic impairment:

               -  Diagnosis of chronic (> 6 months) hepatic impairment

               -  Score on the Child-Pugh-Turcotte (CPT) scale of 7-9 at screening (Child Pugh
                  Class B).

          -  For individuals with severe hepatic impairment:

               -  Diagnosis of chronic (> 6 months) hepatic impairment

               -  Score on the CPT scale of 10-15 at screening (Child Pugh Class C)

          -  For individuals with normal hepatic function:

               -  Hepatitis C Virus (HCV) antibody and hepatitis B surface antigen negative

        Key Exclusion Criteria:

          -  All individuals:

               -  Pregnant or nursing female or male with pregnant female partner

               -  HIV infection

               -  History of clinically significant illness or any other medical disorder that may
                  interfere with the individual's treatment, assessment or compliance with the
                  protocol

          -  For individuals with moderate or severe hepatic impairment:

               -  Active HCV infection

               -  Current hepatic encephalopathy

               -  Variceal bleeding in the last 6 months unless banded

               -  Prior placement of a portosystemic shunt

               -  History of hepatorenal or hepatopulmonary syndrome

               -  Spontaneous bacterial peritonitis currently or within the last 6 months

               -  Hospitalization within the last 2 months related to cirrhosis

               -  Confirmed hypotension

               -  Suspicion of hepatocellular carcinoma

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Safety and Efficacy Study of DAV132 in Healthy Volunteers
Condition: Healthy
Intervention: DAV132; Moxifloxacin; Negative Control
Intervention description: DAV132 is associated to moxifloxacin or it is evaluated alone; Moxifloxacin is used alone or associated to DAV132; Moxifloxacin is used alone
Intervention MeSH terms: Moxifloxacin
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine whether DAV132 is safe and effective for capturing
      fecal residues of moxifloxacin in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy volunteers

          -  Normal digestive transit, with usually one daily stool.

          -  Females participating in the study :

        must be either of non-child bearing potential (surgically sterilized at least 3 months
        prior to inclusion, or postmenopausal or having a negative pregnancy test and be not
        breastfeeding at screening, and using abstinence or a double contraception method during
        the treatment period and for additional period of 2 weeks after the end of investigational
        treatment.

          -  Having given and signed the written study informed consent prior to undertaking any
             study-related procedure.

          -  Covered by the French Health Insurance system.

        Exclusion Criteria:

          -  Any history or presence of clinically relevant cardiovascular, pulmonary,
             gastrointestinal, hepatic, renal, metabolic, haematological, neurological, bone and
             joint, muscular, psychiatric, systemic, ocular, gynaecologic (if female), or
             infectious disease, or signs of acute illness.

          -  Contra-indications to fluoroquinolones, or risk factors for adverse events associated
             to fluoroquinolones.

          -  Subjects with a family history of, or actual glucose-6-phosphate dehydrogenase
             deficiency should be excluded.

          -  Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase
             deficiency or glucose-galactose malabsorption should be excluded.

          -  Contra-indications to DAV132, risk of gastrointestinal obstruction, perforation or
             haemorrhage, recent digestive tract surgery.

          -  Fecal colonisation by Clostridium difficile.

          -  Recent history of hospitalisation (within 3 months prior to inclusion).

          -  Any antibiotic administration within 3 months before inclusion.

          -  Any vaccination within the last 28 days.
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-954 in Healthy Adult Participants
Condition: Healthy Volunteers
Intervention: TAK-954; TAK-954 Placebo
Intervention description: TAK-954 infusion administered intravenously.; TAK-954 placebo-matching infusion intravenous.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
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 safety, tolerability, and PK of single ascending
      intravenous doses of TAK-954.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=)
             32 kilogram per square meter (kg/m^2), weighing >=50 kilogram (kg) at screening.

          2. Medically healthy with no clinically significant medical history, physical
             examination, laboratory profiles, vital signs, orthostatic vital signs, or ECGs, as
             deemed by the Investigator or designee.

          3. Continuous non-smoker who has not used nicotine-containing products for at least 3
             months prior to the first dose and throughout the study, based on participant
             self-reporting.

        Exclusion Criteria:

          1. History or presence of alcoholism or drug abuse within the past 2 years prior to the
             first dosing.

          2. Has infrequent bowel movements (less than approximately once per day) within 30 days
             prior to first dosing.

          3. Recent history of abnormal bowel movements, such as diarrhea, loose stools, or
             constipation, within 2 weeks of first dosing.
Phase 1 Bioavailability Study of Apixaban Solution Formulation Relative to Apixaban Tablets in Healthy Subjects
Condition: Healthy Volunteers
Intervention: Apixaban
Intervention MeSH terms: Apixaban
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the oral bioavailability of Apixaban solution
      formulation (Treatment B, 10 mg as 25 mL x 0.4 mg/mL) relative to Apixaban tablets (Treatment
      A, 10 mg as 2 x 5 mg tablets) in healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects as determined by no clinically significant deviation from normal in
             medical history, physical examination, ECGs, and clinical laboratory determinations

        Exclusion Criteria:

          -  Any significant acute or chronic medical illness or relevant trauma (e.g., history of
             chronic hypertension, bacterial endocarditis, hemorrhagic stroke, motor vehicle
             accident resulting in significant head trauma or internal injuries)

          -  History or evidence of abnormal bleeding or coagulation disorder (e.g., easy bruising
             or gingival bleeding, prolonged bleeding after dental extraction, postpartum, or after
             trauma, wounds or surgery)
Single Rising Dose Study of BI 207127 NA in Healthy Male Asian Volunteers and Single Dose Study of BI 207127 NA in Healthy Male Caucasian Volunteers
Condition: Healthy
Intervention: Matching placebo (low dose); BI 207127 NA (medium dose); BI 207127 NA (low dose); Matching placebo (medium dose); BI 207127 NA (high dose); Matching placebo (high dose)
Intervention description: single dose of matching placebo; Single does of BI 207127 NA; single dose of BI 207127 NA; Single dose of matching placebo; Single dose of BI 207127 NA; Single dose of matching placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 60.0
Sex: Male
Minimum age: 20 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of the study is to evaluate safety, tolerability and pharmacokinetics in Asian and
      Caucasian healthy male volunteers administered BI 207127 NA.
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy male volunteers

          2. Chinese ethnicity or Japanese ethnicity or Caucasian

          3. Body Mass Index (BMI) = 18.5 and BMI =25 kg/m2 for Japanese and Chinese, BMI =18.5 and
             BMI = 29.9 kg/m2 for Caucasians

        Exclusion criteria:

          1. Any finding of the medical examination (including Blood pressure(BP), Pulse rate (PR)
             and Electrocardiogram (ECG)) deviating from normal and of clinical relevance

          2. Any evidence of a clinically relevant concomitant disease

          3. Intake of drugs with a long half-life (> 24 hours) within at least one month or less
             than 10 half-lives of the respective drug prior to administration or during the trial