bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Pharmacokinetics of Tezepelumab in Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Tezepelumab
Intervention description: Single dose subcutaneous injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: No masking is used. All involved know the identity of the intervention assignment.
Enrollment: 18.0
Sex: All
Minimum age: 5 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Mild asthma; Moderate asthma; Severe asthma

Summary:

      This study will evaluate the pharmacokinetic (PK) profile of a single subcutaneous (SC) dose
      of tezepelumab in children aged ≥ 5 to 11 years with asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent and written informed assent and any locally required
             authorisation obtained from the subject and legal representative prior to any study
             related procedure taking place.

          -  Age 5 to 11 years (inclusive) at Visit 1 and Visit 2 (Day 1). Type of Subject and
             Disease Characteristics

          -  Documented physician diagnosed asthma for at least 6 months prior to Visit 1.

          -  Documented treatment with total daily dose of either low, medium, or high dose ICS for
             at least 6 months, as described in Step 2 to Step 4 of GINA guidelines (GINA 2020)
             with stable dose for at least 3 months prior to Visit 1.

          -  Pre bronchodilator (BD) FEV1 of ≥ 50% of predicted normal value at Visit 1

          -  Body weight ≥ 16 kg at Visit 1 and Visit 2 (Day 1).

        Exclusion Criteria:

          -  History of any clinically significant disease or disorder other than asthma which, in
             the opinion of the Investigator, may either put the subject at risk because of
             participation in the study, or influence the results or the subject's ability to
             participate in the study.

          -  History of a deterioration in asthma or asthma exacerbation that required a burst of
             systemic corticosteroids within 6 weeks of Visit 1, up to and including Visit 2 (Day
             1).

          -  History of hospitalisation (overnight admission) for asthma within 3 months of Visit
             1, up to and including Visit 2 (Day 1).

          -  History of a life threatening asthma exacerbation requiring intubation or mechanical
             ventilation.

          -  History of systemic corticosteroid use for the maintenance treatment of asthma within
             6 weeks of Visit 1, up to and including Visit 2 (Day 1) and discouraged until EOS.

          -  History of cancer.

          -  History of hypersensitivity or anaphylactic reaction to any biologic therapy.
A Single Dose Study To Test Two Pediatric Forms Of Ritlecitinib Compared With Adult Ritlecitinib In Healthy Adults
Condition: Healthy Participants
Intervention: ritlecitinib; ritlecitinib; ritlecitinib
Intervention description: 30 mg intact adult capsule; 10 mg pediatric capsule; 30 mg spray congealed beads
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A phase I, single dose study to test two forms of pediatric ritlecitinib compared to adult
      ritlecitinib in healthy adults aged 18-55 years old. Approximately 12 adults will participate
      for approximately 2.5 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants who are healthy as determined by medical evaluation
             including a detailed medical history, complete (full) physical examination, which
             includes BP and pulse rate measurement, clinical laboratory tests, and 12-lead ECG.

          -  BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological,
             dermatological, or allergic disease (including drug allergies, but excluding
             untreated, asymptomatic, seasonal allergies at the time of dosing).

          -  Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).

          -  Known immunodeficiency disorder, including positive serology for HIV at screening, or
             a first degree relative with a hereditary immunodeficiency

          -  Infection with hepatitis B or hepatitis C viruses.

          -  History of any lymphoproliferative disorder

          -  Known present or a history of malignancy other than a successfully treated or excised
             nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in
             situ
Tau Imaging in Professional Fighters
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Flortaucipir F18; Brain PET scan
Intervention description: IV injection, 370 megabecquerel (MBq) (10 mCi); positron emission tomography (PET) scan of the brain 75-105 minutes post injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Subjects enrolled in the Professional Fighters Brain Health Study (PFBHS) will receive
      flortaucipir to explore its use as a biomarker for brain injury related to repetitive head
      trauma and to examine the relationship between clinical presentation and tau deposition.
    

Eligibility criteria:

        Inclusion Criteria:

        All Subjects

          -  Currently enrolled in the PFBHS protocol and have participated in a minimum of 10
             professional fights

          -  Can tolerate Positron Emission Tomography (PET) scan procedures

          -  Have the ability to provide informed consent

        Subjects with cognitive impairment

          -  Have subjective cognitive complaints or objective decline or impairment as determined
             by the investigator

        Exclusion Criteria:

          -  Have behavior dysfunction that is likely to interfere with imaging

          -  Are claustrophobic or otherwise unable to tolerate the imaging procedure

          -  Have current clinically significant cardiovascular disease or clinically significant
             abnormalities on screening electrocardiogram

          -  A history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs
             that are known to cause QT-prolongation

          -  Have a current clinically significant infectious disease, endocrine or metabolic
             disease, pulmonary, renal or hepatic impairment, or cancer

          -  Have had a non-study related radiopharmaceutical imaging or treatment procedure within
             7 days prior to the study imaging session

          -  Have current drug or alcohol dependence or alcohol dependence within the past 2 years
Dose Escalation and Dose Expansion Study of IPN60090 in Patients With Advanced Solid Tumours
Condition: Solid Tumor
MeSH terms: Neoplasms
Intervention: IPN60090; pembrolizumab; paclitaxel; IPN60090 single administration
Intervention description: Oral capsules given daily; An intravenous solution in single-use vial to be diluted for infusion.; An intravenous solution in single-use vial to be diluted for infusion.; Oral capsules given once
Intervention MeSH terms: Paclitaxel; Pembrolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the protocol is to determine safety, tolerability, recommended dose (RD),
      pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumour activity of IPN60090
      as a single agent (Part A) and in combination with pembrolizumab (Part B) or paclitaxel (Part
      C) in patients with advanced solid tumours and to evaluate food effect (Part D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients ≥18 years of age

          -  Patients with solid tumours who have received at least one line of therapy for
             advanced disease

          -  Measurable or non-measurable evaluable disease per RECIST 1.1

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤1

          -  Standard of care and/or any investigational therapies must have been completed at
             least 3 weeks prior to treatment

        Exclusion Criteria:

          -  Prior malignancy within the previous 2 years except for locally curable cancers that
             have been cured, such as basal or squamous cell skin cancer, or carcinoma in situ of
             the cervix, breast or bladder

          -  Known primary central malignancy or symptomatic central nervous system metastasis

          -  Major surgical intervention within 28 days before study drug administration

          -  Significant acute or chronic infections
Modeling Mood Course to Detect Markers for Effective Adaptive Interventions- Aim 3
Condition: Bipolar Disorder; Psychosocial Intervention
MeSH terms: Bipolar Disorder
Intervention: Mobile intervention
Intervention description: The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention.
Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo.
Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: This study uses a design known as a microrandomized trial. Whereas a multi-arm trial randomizes a subject to an intervention group only once at the start of the study, a microrandomized trial repeatedly randomizes a subject to an intervention group throughout the study. In addition to an overall effect of an intervention on proximal outcomes, a microrandomized trial allows one to determine if the effect is modified by momentary factors (e.g., current mood, day of the week, day in the study).
For the present study, every subject has a equal chance of being assigned to one of two intervention groups at each of 84 time points (2 daily x 42 days). At each time point, the two intervention groups are to either receive a prompt based on Acceptance and Commitment Therapy (ACT) or not receive such a prompt. Regardless of the assigned group, subjects are asked to assess their mood, stress, and activity at every time point prior to assignment to intervention group.
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mood; stress; sleep; circadian rhythm; medical adherence; acceptance and commitment therapy; microintervention

Summary:

      This study is a 6-week micro-randomized trial investigating the feasibility of a mobile
      health platform. Its long-term objective is to develop a mobile health platform for the
      translation of a psychosocial intervention for bipolar disorder (BP) into an effective and
      evidence-based adaptive intervention. In this aim of the study, investigators will evaluate
      how individuals with BP respond to a microintervention based in acceptance and commitment
      therapy (ACT) that is delivered with a mobile app.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals diagnosed with Bipolar Disorder

          -  have agreed to be contacted for future research

          -  have a smart-phone

          -  have a diagnosis of bipolar disorder.

        Exclusion Criteria:

        -
A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects
Condition: Healthy Adult Male
Intervention: OPC-41061
Intervention MeSH terms: Tolvaptan
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: Male
Minimum age: 20 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To assess the bioequivalence of OPC-41061 OD tablets and OPC-41061 conventional tablets at 15
      and 30 mg in healthy adult male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight of at least 50.0 kg

          -  BMI [body weight in kg / (height in m)2] of at least 17.6 kg/m2 and less than 25.0
             kg/m2

          -  Judged by the investigator or subinvestigator to be capable of providing written
             informed consent prior to the start of any trial-related procedures and capable of
             complying with the trial procedures for this study.

        Exclusion Criteria:

          -  Judged by the investigator,subinvestigator, or sponsor to have a clinically
             significant abnormality in results of the screening examination (including a notable
             deviation from the site's standard values) or a medical history that could place the
             subject at risk or affect the evaluation of drug absorption, distribution, metabolism,
             or excretion

          -  History of alcohol or drug dependence or abuse within 2 years prior to the trial

          -  History or current infection with hepatitis or acquired immunodeficiency syndrome
             (AIDS) or carrier of hepatitis B positive surface antigen (HBsAg), anti-hepatitis C
             virus (HCV), human immunodeficiency virus (HIV), or syphilis based on the results of
             the Treponema pallidum (TP) antibody test or rapid plasma reagin (RPR) test

          -  History of any severe drug allergy

          -  Positive results in alcohol screening test or urine drug screening test at time of
             screening examination or trial site admission

          -  Use of any other investigational medicinal product (IMP) within 120 days prior to
             Period 1 IMP administration

          -  Consumption of any food or beverage containing St. John's wort within 14 days prior to
             Period 1 IMP administration

          -  Consumption of any food or beverage containing grapefruit, Seville orange, or star
             fruit within 7 days prior to Period 1 IMP administration

          -  Judgment by the investigator or subinvestigator that the subject should not
             participate in the study for any other reason.
A Study of the Use of Microneedle Patches to Deliver Topical Lidocaine in the Oral Cavity
Condition: Topical Anaesthesia
Intervention: Microneedle Patch; Patch with no microneedles
Intervention description: At the first visit participants will have either the buccal or palatal treated. At the second visit the other area will be treated.; At the first visit participants will have either the buccal or palatal treated. At the second visit the other area will be treated.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To look at the effect on patient perceived pain resulting from infiltration injection with
      local anaesthetic in a dental syringe with prior application of topical anaesthetic to the
      oral mucosa on a microneedle patch compared to a patch with no microneedles. To look at the
      safety of the patches when applied to the oral mucosa.
    

Eligibility criteria:

        Inclusion Criteria:

          1. be aged 18 years and over, of either gender and in good health;

          2. be willing and physically able to carry out all study procedures;

          3. be willing and able to give Informed Consent and provide details of any medical
             history;

          4. be available for all of the study dates

          5. have a good standard of oral hygiene and gingival health

          6. must have 1 premolar or canine in each quadrant that has no/minimal restorations

        Exclusion Criteria:

          1. presence of soft tissue oral pathology;

          2. presence of advanced periodontal disease;

          3. Individuals with any serious health conditions, that would preclude participation, in
             the professional judgement of the Study Dentist;

          4. individuals with known allergies or sensitivities to local anaesthetics

          5. have participated in another clinical trial in the last 30 days

          6. in the opinion of the investigator unable to comply fully with the trial requirements.

          7. the subject is an employee of the Sponsor or the site conducting the study
A Study to Provide a Better Understanding of Baraclude's Pharmacokinetic Properties in a Real World Clinical Setting
Condition: Hepatitis B Virus
MeSH terms: Hepatitis B; Hepatitis
Intervention: Baraclude
Intervention description: Specified dose on specified day
Intervention MeSH terms: Entecavir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      A Pharmacokinetics study of Baraclude in a real world clinical setting in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com.

          -  Participants with chronic hepatitis B (CHB) (excluding participants with a
             superinfection) who have been confirmed to have CHB.

          -  Participants who are being treated with 0.5 mg daily Baraclude for a minimum of 10
             consecutive days prior to the study enrollment.

          -  Body mass index (BMI) of 18.5 to 30 kg/m2 (BMI = body weight [kg]/height [m]2)

        Exclusion Criteria:

          -  Current or recent (within 3 months of Baraclude administration) gastrointestinal
             disease that could impact upon the absorption of study drug.

          -  Any gastrointestinal surgery that could impact upon the absorption of study drug.

          -  Donation of blood to a blood bank or in a clinical study (except a screening visit)
             within 4 weeks of study drug administration (within 2 weeks for plasma only).

        Other protocol defined inclusion/exclusion criteria could apply.
Nintedanib and Weekly Docetaxel in Lung Adenocarcinoma
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Adenocarcinoma; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung
Intervention: Docetaxel; Nintedanib; Nintedanib; Nintedanib; Nintedanib
Intervention description: Low Dose; Medium dose; High dose; Continuous high dose
Intervention MeSH terms: Docetaxel; Nintedanib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase I study. To determine the MTD (Maximum Tolerated Dose) of nintedanib + weekly Docetaxel
      in patients with locally advanced or metastatic lung adenocarcinoma after failure of
      platinum-based first line chemotherapy.
    

Eligibility criteria:

        Inclusion criteria:

        -Patients with histologically/ cytologically confirmed locally advanced (Stage IIIB) or
        metastatic (Stage IV) lung adeno carcinoma after failure of first line platinum - based
        chemotherapy (patients with non-target lesion only are eligible).

        First line chemotherapy may include continuation or switch maintenance therapy. One prior
        adjuvant and/or neoadjuvant chemotherapy line is accepted. Prior immunotherapy is allowed.

          -  ECOG inferior or equal to 1 at screening.

          -  Further inclusion criteria apply

        Exclusion criteria:

          -  Patients who have received more than one prior line of chemotherapy (i.e. second or
             third line chemotherapy) for advanced or metastatic NSCLC.

          -  Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR)
             mutation or patients known to be positive for ALK translocation

          -  Further exclusion criteria apply.
A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male Subjects
Condition: Healthy Volunteers
Intervention: Placebo; ASC-01
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Male
Minimum age: 20 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and
      sertraline Tablet in Japanese healthy male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male volunteers aged 20 to 40 years.

          -  Have a body mass index (BMI) between 18.5 and 25.0 kg/m2 and a weight of at least 50
             kg.

        Exclusion Criteria:

          -  History of any clinically important disease or disorder which, in the opinion of the
             Investigator, may either put the volunteer at risk because of participation in the
             study.

          -  History or presence of gastrointestinal, hepatic, or renal disease or any other
             condition known to interfere with absorption, distribution, metabolism, or excretion
             of drugs.

          -  Any clinically significant abnormalities in the physical examination, clinical
             laboratory values, 12-lead ECG, or vital signs, as judged by the Investigator.