bioihbjkbjnl/mcl2 huggingface dataset:
Transfusion of Biotinylated Red Blood Cells
Condition: Anemia
Intervention: Biotin-Labeled Red Blood Cells (RBCs)
Intervention description: 500 mL of blood will be drawn from each participant. The blood will be processed into a packed RBC unit.
For participants 1 and 2, the RBCs will be labeled with biotin at three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and the labeled RBCs will be re-infused into the participant on the same day of collection.
For participants 3 through 8, the RBCs will be stored at 2-6 C for 40-42 days before being labeled with three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and re-infused into the participant.
Participants will have a 5 mL blood sample drawn within a few minutes of the re-infusion, the day after the re-infusion and then weekly for 70 days (10 weeks) to track the survival of the infused biotin labeled RBCs.
Intervention MeSH terms: Biotin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Red Blood Cell (RBC) transfusion; Biotin labeled red blood cells

Summary:

      The purpose of this research is to study how red blood cells (RBCs) survive in a person's
      circulation, and how that survival may be different in red blood cells that are donated and
      stored prior to being transfused. Investigators will study this by collecting blood samples
      from participants, "labeling" RBCs with a naturally occurring vitamin, biotin. The RBCs will
      then be re-infused back into the participant and blood samples will be taken weekly for 10
      weeks to assess the number of labeled cells in the samples.
    

Eligibility criteria:

        Inclusion Criteria:

          -  in good health

        Exclusion Criteria:

          -  anemia (defined as hemoglobin < 8 g/dL)

          -  chronic disease, including diabetes, heart or lung disease, poorly managed
             hypertension, and peripheral vascular disease

          -  ongoing consumption of biotin or raw egg supplements

          -  history of a bleeding disorder

          -  evidence of anemia at initial screening

          -  women who are pregnant or plan to become pregnant
STUDY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS
Condition: Neoplasms
Intervention: talazoparib
Intervention description: Talazoparib will be administered orally on a continuous basis. Each cycle will consist of 28 days.
Intervention MeSH terms: Talazoparib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A phase1 study to evaluate the PK (single dose and multiple doses) and safety of talazoparib
      1 mg Once Daily in Chinese adult participants with advanced solid tumors. A maximum of
      approximately 15 participants will be enrolled such that approximately 12 evaluable
      participants complete the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological diagnosis of locally advanced or metastatic solid tumor
             that is resistant to standard therapy or for which no standard therapy is available.

          -  ECOG Performance Status 0 or 1.

          -  Adequate Bone Marrow, Renal and Liver Function.

        Exclusion Criteria:

          -  Participants with brain metastases.

          -  Current or anticipated use of P gp inhibitor and/or inducer within 7 days prior to
             study intervention from lead-in to end of Cycle 1; concomitant use of potent P gp
             inhibitor after Cycle 1 until the end of treatment.

          -  Prior treatment with a PARP inhibitor.
A Study of LY3202626 in Healthy Participants
Condition: Healthy
Intervention: LY3202626 (R-Fasting); LY3202626 (T1-Fasting); LY3202626 (T1-Fed)
Intervention description: Administered orally; Administered orally; Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purposes of this study are to determine:

        -  If there are any differences in the way LY3202626 is handled by the body when taken in
           two different forms

        -  Whether a high fat meal affects the way the body handles LY3202626

        -  How well tolerated LY3202626 is

      There are three (3) study periods for all participants. Participants will be admitted to the
      clinical research unit (CRU) each period and will be discharged from the CRU following the
      completion of 2 overnight stays and up to 36 hours after dosing with LY3202626.

      The study will last about 50 days, not including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined by medical history and physical
             examination

          -  Female participants must be of non-childbearing potential confirmed by medical history
             or menopause

          -  Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²)
             inclusive, at screening

        Exclusion Criteria:

          -  Are investigative site personnel directly affiliated with this study and their
             immediate families

          -  Are currently enrolled in a clinical trial involving an investigational product or any
             other type of medical research judged not to be scientifically or medically compatible
             with this study

          -  Have participated, within the last 30 days, in a clinical trial involving an
             investigational product. If the previous investigational product has a long half-life,
             3 months or 5 half-lives (whichever is longer) should have passed

          -  Have previously completed or withdrawn from this study or any other study
             investigating LY3202626, and have previously received the investigational product

          -  Have a history of or current cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine, hematological, or neurological disorders capable of
             significantly altering the absorption, metabolism, or elimination of drugs; of
             constituting a risk when taking the investigational product; or of interfering with
             the interpretation of data

          -  Have a history of head trauma with loss of consciousness within the last 5 years

          -  Have known or ongoing psychiatric disorders
A Study in Healthy Men to Measure the Amount of BI 730357 in the Blood When Taken as a Tablet
Condition: Healthy
Intervention: BI 730357; BI 730357 mixed with [C-14] BI 730357 BS
Intervention description: Oral dose; Intravenous dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the absolute oral bioavailability of BI 730357 administered as tablet compared
      with [C-14]BI 730357 BS administered as intravenous microtracer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects according to the assessment of the investigator, as based on a
             complete medical history including a physical examination, vital signs (Blood Pressure
             (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests

          -  Age of 18 to 65 years (inclusive)

          -  Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)

          -  Signed and dated written informed consent prior to admission to the study, in
             accordance with Good Clinical Practice (GCP) and local legislation

          -  Further inclusion criteria apply

        Exclusion Criteria:

          -  Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR)
             or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant
             by the investigator

          -  Repeated measurement of systolic blood pressure outside the range of 90 to 139 mmHg,
             diastolic blood pressure outside the range of 45 to 89 mmHg, or pulse rate outside the
             range of 40 to 100 bpm

          -  Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          -  Any evidence of a concomitant disease assessed as clinically relevant by the
             investigator

          -  Clinically significant gastrointestinal (including known or suspected inflammatory
             bowel disease), hepatic, renal, respiratory, cardiovascular, metabolic, immunological
             or hormonal disorders

          -  Further exclusion criteria apply
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
Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL
Condition: Non Hodgkins Lymphoma; Chronic Lymphocytic Leukaemia
MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Tirabrutinib
Intervention description: Capsules administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to evaluate the safety and tolerability of tirabrutinib
      (formerly ONO/GS-4059) given as monotherapy to participants with relapsed/refractory
      non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL).
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Males or females with a confirmed diagnosis of and documented history of relapsed or
             refractory malignant disease (B-cell lymphoma and/or CLL) for which no therapy of
             curative or high priority exists and for whom treatment with a Btk inhibitor may be
             deemed appropriate.

          2. Age ≥ 18 years.

          3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

        Key Exclusion Criteria:

          1. Central nervous system (CNS) lymphoma.

          2. Women who are pregnant or lactating.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Clavulanic Acid; Placebo
Intervention description: Drug will be given in 250mg capsules.; Placebo
Intervention MeSH terms: Clavulanic Acids; Clavulanic Acid
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, parallel group inpatient study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      A dose-escalation study to determine the optimum dose of Clavulanic Acid (CLAV) for effects
      on craving and efficacy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be able to verbalize understanding of consent form

          2. Be male or female adult volunteers ages 18-65 inclusive.

          3. Have a Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of cocaine use disorder,
             moderate to severe in early remission

          4. Have a Body Mass Index (BMI) of 17.5 to 39.9 kg/m2; and a total body weight of at
             least 45 kg (99 lbs.)

          5. Have a history and brief physical examination that demonstrate no clinically
             significant contraindication for participating in the study, and/ or significant or
             unstable medical or psychiatric illness.

        Exclusion Criteria:

          1. Have a current DSM-5 substance use disorder, mild, moderate, or severe, on any drug of
             abuse other than nicotine, caffeine, and cocaine use disorder in early remission
             verified by Urine Drug Screen (UDS). Alcohol use disorder and marijuana use disorder,
             mild without withdrawal symptoms, will be permitted.

          2. Have any previous medically adverse reaction to CLAV, Augmentin, penicillin,
             Ticarcillin, cephalosporin, or any beta-lactam drug.

          3. Have any illness, condition, and use of medications, in the opinion of the principal
             investigator, sub-investigators which would preclude safe and/or successful completion
             of the study.

          4. Report having human immunodeficiency virus (HIV) infection or test positive for HIV
             during screening

          5. Be pregnant (females).

          6. Unable to tolerate MRI scan for duration of 60 minutes for physical or psychological
             reasons.
The Interaction Between Diabetes and Estradiol on Human Brain Metabolism in Postmenopausal Women
Condition: Diabetes Type 2; Dementia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Estradiol patch
Intervention description: transdermal 17β-estradiol patch
Intervention MeSH terms: Estradiol
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Primary Objective: The primary objective is to determine whether the effects of glucose and ketone body uptake to the brain in response to 8-week administration of transdermal 17β-estradiol differ in postmenopausal women with and without type 2 diabetes.
Masking: None (Open Label)
Enrollment: 12.0
Sex: Female
Minimum age: 60 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: women's health; estradiol; postmenopausal

Summary:

      The primary aim of this study is to test whether type 2 diabetes interacts with estradiol on
      brain metabolism in vivo in humans. This will be accomplished by imaging brain metabolism
      using positron emission tomography before and after short-term administration of transdermal
      17β-estradiol in 10 postmenopausal women with diabetes and 10 non-diabetic postmenopausal
      women.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Willing to provide written informed consent

          2. Stated willingness to comply with all study procedures and availability for the
             duration of the study

          3. Female, postmenopausal, aged 60-80

          4. Normal results on recommended healthcare screenings (e.g., mammogram, pap smear,
             colonoscopy)

          5. BMI 20-35 kg/m2

          6. No evidence of dementia or mild cognitive impairment (MoCA score >25)

          7. Able to access reliable transportation to study and intervention visits

        Exclusion Criteria:

          1. Use of hormone replacement therapy within the past 3 months

          2. History of renal, heart, liver, or neurological disease; head injury with loss of
             consciousness in the past 5 years; chronic pain, anxiety or depression

          3. Presence of medical conditions that might contraindicate estrogen use (e.g.,
             unexplained vaginal bleeding, history of reproductive tissue cancer, thrombosis)

          4. Currently taking insulin, metformin, or any other drug or medication judged by the
             study physician to affect safety or research outcomes of interest

          5. Involved in another research study

          6. Contraindications for MRI or PET scanning

          7. Current smoker
The Capillary Index Score Trial
Condition: Acute Stroke; Brain Ischemia; Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Brain Ischemia; Ischemia
Intervention: Endovascular Treatment (EVT)
Intervention description: EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tPA (tissue plasminogen activator) directly at the site of the clot. The protocol calls for use of the Trevo stent retriever (Stryker Neurovascular) for the first pass of clot removal.
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be assigned to one of two groups based on the outcome of diagnostic evaluation. Treatment will be identical for the two groups.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: The participants and investigators evaluating 90 day outcomes will be blinded to the group.
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: capillary index score; acute ischemic stroke; collateral circulation; cerebral ischemia; diagnostic imaging

Summary:

      This study seeks to investigate the capillary index score (CIS) to further improve patient
      selection of endovascular treatment (EVT) in acute ischemic stroke (AIS).

      The hypothesis or idea being tested:

      Patients with favorable CIS who are successfully revascularized with EVT can have successful
      outcomes with an extended time window for treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Anterior circulation acute ischemic stroke due to blockage of the intracranial
             internal carotid artery or middle cerebral artery (M1)

          2. Within 24 hours of onset of symptoms

          3. NIHSS Score is 8 or greater

        Exclusion Criteria:

          1. Contra-indication for IAT found on initial CT

          2. Intracranial hemorrhage

          3. Stroke mimics (tumor, herpetic encephalitis, etc.)

          4. More than 1/3 hypodensity on non-enhanced head CT prior to intervention

          5. ASPECT Score less than 6

          6. Pre-existing disability defined as modified Rankin Scale (mRS) score more than 2

          7. Pregnant women
General Anesthesia Emergence Induced by Methylphenidate
Condition: Delayed Emergence From Anesthesia
MeSH terms: Delayed Emergence from Anesthesia
Intervention: Methylphenidate HCl; Placebo
Intervention description: Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL); 20 mg of placebo (PO) will be given 2 hours prior to surgery
Intervention MeSH terms: Methylphenidate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess whether methylphenidate affects time of emergence from
      isoflurane general anesthesia. Time to emergence was defined as the time from termination of
      isoflurane to extubation. After stopping isoflurane infusion, when the patient breaths
      spontaneously with adequate tidal volume and respiratory rates, the trachea will be extubated
      and the time will be recorded.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 to 65 years of age

          -  ASA I or II

          -  Capable and willing to consent

          -  Participants literate in English language

        Exclusion Criteria:

          -  ADHD with current use of methylphenidate

          -  Hypersensitivity to methylphenidate

          -  ASA III, IV or V

          -  Patients with severe visual or auditory disorder

          -  Illiteracy

          -  Presence of a clinically diagnosed anxiety, agitation, major psychiatric condition
             such as bipolar disorder, uncontrolled major depression, schizophrenia

          -  Tics or Tourette's syndrome

          -  Glaucoma

          -  Hypertension, history of atrial arrhythmias (atrial fibrillation, atrial flutter),
             myocardial infarction

          -  Taking or have taken within the past 14 days a monoamine oxidase inhibitor or MAOI
             (Selegiline)

          -  Subjects who have participated or are currently participating in a clinical trial of
             an investigational drug within 30 days prior to surgery

          -  Any condition, which in the opinion of the investigator would make subject ineligible
             for participation in the study such as history of unstable cardiovascular, pulmonary,
             renal, hepatic, neurologic (seizures), hematologic or endocrine abnormality
             (hyperthyroidism, unstable Diabetes type I/II)