bioihbjkbjnl/mcl2 huggingface dataset:
Extended Administration of Polyethylene Glycol (PEG) Interferon Alfa-2b in Participants With Solid Tumors (C/I97-349/MK-4031-009)
Condition: Neoplasms
Intervention: PEG Interferon Alfa-2b; Acetaminophen
Intervention description: Participants receive PEG interferon alfa-2b administered by SC injection, in doses ranging from 0.75 mcg/kg OW up to 7.5 mcg/kg OW, for up to 40 weeks of treatment.; Participants receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and continue acetaminophen 500 to 1000 mg after administration every 4 to 6 hours as needed. The total daily dose of acetaminophen should not exceed 3000 mg.
Intervention MeSH terms: Acetaminophen; Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study is an extension study to base study protocol C/I97-188 (MK-4031-006). Its primary
      purpose is to assess the safety and tolerability of extended administration of polyethylene
      glycol (PEG) interferon alfa-2b in participants with solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Had a response of stable disease or better in PEG interferon alfa-2b base study
             C/I97-188 (MK-4031-006).

          -  Has a Performance Status of 0 (normal activity), 1 (symptoms, but fully ambulatory),
             or 2 (symptomatic, but in bed <50% of the day).

          -  Is enrolled within two weeks of completing their last dose of PEG Interferon alfa-2b
             on the previous study and has not have received any other therapy during this period.

        Exclusion Criteria:

          -  Discontinued prior to completing PEG interferon alfa-2b base study C/I97-188
             (MK-4031-006).

          -  Is pregnant or nursing.
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).
Condition: Giant Cell Arteritis
MeSH terms: Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis
Intervention: Tocilizumab
Intervention description: TCZ will be administered by IV infusion at two dose levels Q4W. The maximum dose of TCZ that will be administered is 800 mg. The dose of TCZ infusion will be calculated on the basis of body weight measured prior to each infusion.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This study will evaluate the pharmacokinetics, pharmacodynamics, and safety of two dose
      levels of tocilizumab (TCZ) administered by intravenous (IV) infusion every 4 weeks (Q4W) to
      participants with giant cell arteritis (GCA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of GCA as classified according to protocol-specified criteria;

          -  Participants entering Period 1 must be receiving treatment with TCZ 8 mg/kg IV Q4W.

        Exclusion Criteria:

          -  Treatment with any other investigational agent besides TCZ within 12 weeks (or 5
             half-lives of the investigational drug, whichever is longer) prior to screening;

          -  Evidence of serious uncontrolled disease;

          -  Known active current or history of recurrent bacterial, viral, fungal, mycobacterial,
             or other infections;

          -  Active TB requiring treatment within the previous 3 years.
STP206 for the Prevention of Necrotizing Enterocolitis (NEC)
Condition: Necrotizing Enterocolitis
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing
Intervention: STP206; Control
Intervention description: Live Biotherapeutic; Sterile Water
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 1 Day
Maximum age: 4 Days
Healthy volunteers: No

Summary:

      This study is a sequential dose escalation study to assess the safety, tolerability, and
      preliminary NEC-preventative efficacy of two doses of STP206 versus control in very low birth
      weight and extremely low birth weight neonates.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Neonates with birth weights between 2000-500g for Part A and 1500-500g for Part B

          2. Ability to start treatment within four days after birth.

          3. Gestational age between 23 and 32 weeks at birth

          4. Obtaining of informed consent from the subject's mother after full understanding of
             the study purpose and procedures.

          5. Parents who agree to allow the Principal Investigator and his/her staff to follow the
             procedures and assessments required by the protocol

        Exclusion Criteria:

          1. Infants with, or at high probability for, early onset sepsis (positive blood cultures
             or with clinical/histological chorioamnionitis with the expectation of empirical
             antimicrobial therapy for ≥5 days)

          2. Infants with persistent pulmonary hypertension of the newborn (PPHN)

          3. Congenital or chromosomal anomalies

          4. Congenital or acquired gastrointestinal pathology that preclude feeds soon after birth
             (e.g. cleft lip is not an exclusion criterion, but a duodenal atresia is)

          5. Infants in extremis to whom no further intensive care is offered by attending
             neonatologist (e.g., infant being provided only hospice/comfort care)

          6. Other conditions of the infant which, in the opinion of the attending neonatologist,
             preclude participation

          7. Positive maternal HIV status

          8. Participation in another interventional clinical trial

             For Part A of the study, the following additional exclusion criterion will apply:

          9. Small for gestational age neonates, i.e. neonates that weigh less that the 10th
             percentile for their gestational age according to the Estimated Fetal Weight
             Percentile Chart
Study to Evaluate the Effect of Eleclazine on QT, Safety, and Tolerability in Participants With Long QT2 Syndrome
Condition: LQT2 Syndrome
MeSH terms: Long QT Syndrome; Syndrome
Intervention: Eleclazine; Placebo
Intervention description: Tablets administered orally in a single dose; Placebo to match tablets administered orally in a single dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Congenital Long QT Syndrome; LQTS; Sudden Cardiac Death

Summary:

      The primary objective of the study is to evaluate the effect of oral eleclazine (formerly
      GS-6615) on corrected QT (QTc) interval in participants with long QT2 syndrome.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participants with an established diagnosis of LQT2 (by genotype testing)

          -  Mean (of triplicate) QTc interval ≥ 480 msec for at least four out of seven time
             points, determined by standard 12-lead electrocardiogram (ECG), at screening

        Key Exclusion Criteria:

          -  Known mutations associated with long QT syndrome type 1 or long QT syndrome type 3

          -  Known or suspected history of seizures or epilepsy

          -  History of heart failure defined as New York Heart Association (NYHA) Class IV and/or
             known left ventricular ejection fraction (EF) ≤ 45%

          -  Body mass index (BMI) ≥ 36 kg/m^2 at screening

          -  Severe renal impairment at screening (defined as an estimated glomerular filtration
             rate (eGFR) < 30 mL/min/1.73m^2, using the 4 variable modification of diet in renal
             disease (MDRD) equation), as determined by the study center

          -  Abnormal liver function tests at screening, defined as alanine aminotransferase (ALT)
             or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN), or total
             bilirubin > 1.5 x ULN

          -  An aborted cardiac arrest (ACA), implantable cardioverter-defibrillator (ICD)
             implantation, syncopal episode, or appropriate ICD therapy within 3 months prior to
             screening

          -  Any other condition or circumstance that in the opinion of the investigator would
             preclude compliance with the study protocol.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
Condition: Respiratory Syncytial Virus
MeSH terms: Virus Diseases
Intervention: Placebo; MEDI8897 10 mg; MEDI8897 25 mg; MEDI8897 50 mg
Intervention description: Participants will receive placebo intramuscularly.; Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.; Participants will receive a single dose of MEDI8897 25 mg intramuscularly.; Participants will receive a single dose of MEDI8897 50 mg intramuscularly.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 151.0
Sex: All
Maximum age: 12 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Respiratory Syncytial Virus, RSV

Summary:

      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of an
      extended half-life anti-respiratory syncytial virus (RSV) monoclonal antibody compared to
      placebo when administered to healthy preterm infants.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Healthy infants born between 32 weeks 0 days and 34 weeks 6 days gestational age

          -  Infants who are entering their first RSV season at the time of screening

        Key Exclusion Criteria:

          -  Gestational age < 32 weeks 0 days and >34 weeks 6 days

          -  Meets AAP or other local criteria to receive commercial palivizumab

          -  Any fever (≥ 100.4°F [≥ 38.0°C], regardless of route) or lower respiratory illness
             within 7 days prior to randomization

          -  Acute illness (defined as the presence of moderate or severe signs and symptoms) at
             the time of randomization

          -  Active RSV infection (a child with signs/symptoms of respiratory infection must have
             negative RSV testing) or known prior history of RSV infection

          -  Receipt of palivizumab or any RSV vaccine, including maternal RSV vaccination
Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: OCV-501
Intervention description: Before the recommended dose will be decided OCV-501 will be subcutaneously administered once a week at the dose in the study 311-10-001.
After the recommended dose will be decided OCV-501 will be subcutaneously administered once a week at the recommended dose.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Acute myeloid leukemia; WT1

Summary:

      The purpose of this study is to assess the safety of OCV-501 in patients with AML who
      completed the Study 311-10-001 and were judged that there was no relapse by any inspections
      in the end of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who completed the Study 311-10-001 and were judged that there was no relapse
             by any inspections in the end of the study.

          -  Patients who are capable of giving informed consent

        Exclusion Criteria:

          -  Patients failed to discontinue the Study 311-10-001 even though patients met the
             discontinuation criteria.

          -  Patients who have participated in any other clinical trials , excluding the Study
             311-10-001).
Monoclonal Antibody Therapy in Treating Patients With Advanced Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: monoclonal antibody hu3S193
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IV colon cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer

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

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven stage IV colorectal carcinoma.

          -  Failed or refused conventional chemotherapy.

          -  Lewis Y antigen present on more than 50% of tumor cells.

          -  Measurable or evaluable disease.

          -  No central nervous system (CNS) tumor involvement.

          -  Karnofsky 80-100%.

          -  Life expectancy: At least 6 weeks.

          -  Granulocyte count greater than 1,500/mm^3.

          -  Platelet count greater than 100,000/mm^3.

          -  Bilirubin no greater than 1.0 mg/dL.

          -  Prothrombin time less than 3 times upper limit of normal.

          -  Creatinine no greater than 1.4 mg/dL.

          -  Female patients of childbearing age and male patients must be asked to use effective
             contraception during the study.

          -  At least 4 weeks since other prior immunotherapy. Exclusion Criteria

          -  New York Heart Association class III or IV heart disease.

          -  Serious infection requiring antibiotics or other serious illness.

          -  Pregnancy or nursing.

          -  History of bleeding gastric ulcers or pancreatitis.

          -  Diabetes mellitus requiring insulin.

          -  Human antimouse antibodies (HAMA).

          -  No prior mouse monoclonal antibody or antibody fragments.

          -  Illness requiring the use of steroids or other anti-inflammatory agents.

          -  Positive anti-hu3S193 antibody (HAHA) titer.
Minimally Invasive Sensing of Beta-lactam Antibiotics
Condition: Healthy Volunteers
Intervention: Phenoxymethyl Penicillin; Microneedle array
Intervention description: Phenoxymethylpenicillin tablets, 500mg every six hours for six doses, starting the day before study; The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed.
Intervention MeSH terms: Penicillins; Penicillin V
Phase: Phase 1
Study type: Interventional
Primary purpose: Device Feasibility
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics; Penicillin V; Penicillins; Proof of Concept Study; Clinical Trial, Phase I; Microneedle array

Summary:

      This study is an in-house feasibility study of a microneedle biosensor developed within
      Imperial College London.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult >18 years old

          -  Healthy with no evidence of active infection

          -  Previously received penicillin with no adverse effects

        Exclusion Criteria:

          -  High risk of skin soft tissue infection or local skin and soft tissue infection near
             sensor site

          -  Previous history of allergies to adhesive strips or active dermatitis

          -  Penicillin allergy or previous adverse event whilst receiving penicillin

          -  Anaemia on screening bloods (defined as haemoglobin <13 g/dL in males and <12 g/dL in
             females)
A Study to Evaluate the Pharmacokinetics of Dexlansoprazole 30 Milligram (mg) and 60 mg Delayed-release Capsules in Healthy Chinese Participants
Condition: Healthy Volunteers
Intervention: Dexlansoprazole
Intervention description: Dexlansoprazole delayed-release capsule.
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to assess the pharmacokinetics after a single dose of
      dexlansoprazole 30 and 60 mg delayed-release capsules in healthy Chinese participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a healthy adult man or woman of Chinese descent.

          2. Is aged 18 to 45 years, inclusive, at the time of informed consent and study
             medication dose.

          3. Weighs at least 50 kilogram (kg) and has a body mass index (BMI) from 19.0 to 26.0
             kilogram per square meter (kg/m^2), inclusive at Screening Visit.

        Exclusion Criteria:

          1. Has a known hypersensitivity to any component of the formulation of dexlansoprazole or
             other drug with the same mechanism of action (including lansoprazole, omeprazole,
             esomeprazole, rabeprazole, ilaprazole, or pantoprazole), or related compounds.

          2. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol
             abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain
             from alcohol for 48 hours prior to Check-in (Day -1) throughout the confinement and
             for 48 hours prior to each clinic visit and drugs throughout the study.

          3. Has used nicotine-containing products (including but not limited to cigarettes, pipes,
             cigars, chewing tobacco, nicotine patch or nicotine gum) within 28 days prior to
             Check-in (Day -1) or is unwilling to abstain from these products for the duration of
             the study.

          4. Has poor peripheral venous access.

          5. Has donated blood products (such as plasma), whole blood or had a significant blood
             loss (450 millimeter [mL]) within 56 days of Day 1.
Study of the Safety of QRH-882260 Heptapeptide
Condition: Healthy Adults
Intervention: QRH-882260
Intervention description: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 25 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety of orally administered QRH-882260, a
      topically administered Cy5-labeled heptapeptide specific for epithelial growth factor
      receptor (EGFR).
    

Eligibility criteria:

        Inclusion Criteria

          -  Adults age 25 to 100 years

          -  Not pregnant (willing to have pregnancy test if applicable)

          -  No recent illness (infection, URI, virus or flu) within 2 weeks,

          -  Stable health status (i.e. no medication changes within 2 months, no recent surgery,
             etc. per PI)

          -  Willing and able to sign informed consent

          -  Willing and able to drink the peptide and a tap water chaser

          -  Willing and able to get baseline and 24-48 hours post ingestion labs Exclusion
             Criteria

          -  Known allergy to Cy5 or derivatives, such as indocyanine green (ICG)

          -  Subjects on active chemotherapy or radiation therapy

          -  Diabetics on insulin/hypoglycemic (due to fasting requirements)
Bioequivalence Between Single Administration of ASC-01 (Aripiprazole/Sertraline Combination Drug) and Concomitant Single Administration of Aripiprazole and Sertraline, and Food Effect on Pharmacokinetics of ASC-01 in Healthy Male Adults
Condition: Healthy Male Adults
Intervention: ASC-01; Aripiprazole and sertraline
Intervention description: Aripiprazole 3 mg/sertraline 100 mg combination drug; Aripiprazole 3 mg and sertraline 100 mg
Intervention MeSH terms: Aripiprazole; Sertraline
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: Male
Minimum age: 20 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the bioequivalence of aripiprazole between administration of one ASC-01 tablet
      (aripiprazole 3 mg/sertraline 100 mg combination drug) and concomitant administration of one
      aripiprazole 3-mg tablet and two sertraline 50-mg tablets (Cohort 1).

      To investigate food effect on plasma pharmacokinetics of aripiprazole and sertraline by
      single oral administration of ASC-01 under a fasting or fed condition (Cohort 2).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subject at the age between 20 and 40 at the time of informed consent

          -  Subject has a body mass index (BMI = body weight [kg]/height [m]2) of ≥18.5 and <25.0
             kg/m2 at screening

          -  Subject is providing consent for participation in this trial in writing prior to the
             start of the procedures related to this trial, and judged by the investigator or
             subinvestigator to be capable of observing procedures in this trial.

        Exclusion Criteria:

          -  Subject has a clinically significant abnormality in physical findings at screening or
             in medical history that in the investigator's or subinvestigator's opinion may place
             the subject at risk or interfere with outcome variables including drug absorption,
             distribution, metabolism, and excretion.

          -  Subject is judged by the investigator or subinvestigator to be inappropriate for
             participation in this trial.