bioihbjkbjnl/mcl2 huggingface dataset:
Staccato Alprazolam Abuse Liability
Condition: Abuse Liability of Staccato Alprazolam
Intervention: Inhaled placebo + oral placebo; Inhaled alprazolam 0.5 mg; Inhaled alprazolam 1 mg; Inhaled alprazolam 2 mg; Oral alprazolam 1 mg; Oral alprazolam 2 mg; Oral alprazolam 4 m; Oral alprazolam 2 mg qualifying session; Oral placebo qualifying session
Intervention description: Inhaled Staccato placebo + oral placebo; Inhaled Staccato alprazolam 0.5 mg + oral placebo; Inhaled Staccato alprazolam 1 mg + oral placebo; Inhaled Staccato alprazolam 2 mg + oral placebo; Oral alprazolam 1 mg + Inhaled placebo; Oral alprazolam 2 mg + Inhaled placebo; Oral alprazolam 4 mg + Inhaled placebo; Qualifying session (2 mg oral alprazolam); Qualifying control session (oral placebo)
Intervention MeSH terms: Alprazolam
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The crossover schedule is planned according to a 7-treatment, 7-period Latin Square design due to E.J. Williams (1949), which is balanced for first-order carryover effects (Fleiss, 1986). Each subject will receive all treatments in this 7-treatment, 7- period Williams Square crossover design as suggested by Chen & Tsong (2007). This Williams Square will include one replication by 1 subject of each of the 14 sequences
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: In order to reduce discrimination between placebo and active Staccato Alprazolam, taste blinding will be accomplished using a rapidly dissolving, intensely flavored product (candy, strip or breath spray). The product will be administered immediately after each oral capsule dosing (at the -60-min and 0- min time points).
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Compare the abuse liabilities of Staccato Alprazolam, oral immediate-release alprazolam, and
      Staccato Placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects between the ages of 18 to 55 years, inclusive, who have a
             history of substance abuse or dependence on barbiturates and/or benzodiazepine
             receptor agonists for their intoxicating effects

        Exclusion Criteria:

          -  Subjects with a significant current psychiatric illness or taking any psychotropic
             prescription medications for therapeutic uses.
ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan
Condition: Malignant Solid Tumor
MeSH terms: Neoplasms
Intervention: ONO-4538
Intervention description: 1mg/kg, 3mg/kg, 10mg/kg and 20mg/kg ONO-4538 infusion cohorts
Intervention MeSH terms: Nivolumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: ONO-4538; MDX-1106; solid tumors

Summary:

      Evaluation of the safety, tolerability and pharmacokinetics (PK) of a single dose and
      multiple doses of ONO-4538 in Japanese patients with advanced malignant solid tumors, and
      exploratory evaluation of the pharmacological effect and efficacy of ONO-4538.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological diagnosis of solid tumor with at least one measurable
             lesion of ≥ 10mm.

          -  Tumor must be advanced or recurrent which is refractory to standard therapies or for
             which no alternative, appropriate therapy exists.

          -  ECOG Performance Status of 0-1

          -  Life expectancy ≥ 3 months

          -  Other inclusion criteria as specified in the study protocol

        Exclusion Criteria:

          -  History of severe hypersensitivity reactions to other antibodies.

          -  Residual adverse reactions or effect of prior therapy, which deemed to affect the
             safety evaluation of the study drug by the investigator or subinvestigator.

          -  Two or more synchronous tumors, except for adequately treated basal cell cancer or
             cancer in situ, or superficial bladder cancer, or any other cancers from which the
             patient has been disease-free for at least 5 years.

          -  Patients with any active autoimmune disease or a documented history of chronic or
             recurrent autoimmune disease, or current medical condition that requires systemic
             immunosuppressive doses of steroids or other immunosuppressive medications.

          -  Other exclusion criteria as specified in the study protocol
A Study of LY3478006 in Healthy Participants
Condition: Healthy
Intervention: LY3478006 - IV; LY3478006 - SC; Placebo - IV; Placebo - SC
Intervention description: Administered IV; Administered SC; Administered IV; Administered SC
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to learn more about how safe and how well tolerated LY3478006 is
      when given by injection into a vein or just under the skin to healthy participants. Blood
      tests will be done to check how much LY3478006 is in the bloodstream and how long the body
      takes to get rid of it. For each participant, the study will last up to about 16 weeks,
      including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy male or female Japanese or non-Japanese participants, as
             determined by medical history and physical examination

          -  Women not of childbearing potential

          -  Are aged 18 to 55 years (20 to 55 years for Japanese participants), inclusive, at
             screening

        Exclusion Criteria:

          -  Have clinically significant abnormal electrocardiogram (ECG) results

          -  Have persistent abnormal blood pressure or pulse rate, as determined by the
             investigator

          -  Have evidence of orthostatic hypotension, defined as a decrease in systolic or
             diastolic blood pressure greater than or equal to (≥)20 millimeters of mercury (mmHg)
             or ≥10 mmHg, respectively

          -  Have significant history or presence of cardiovascular, respiratory, hepatic,
             ophthalmological, renal, gastrointestinal, endocrine, hematological, neurological, or
             psychiatric disorders

          -  Have a history or presence of mononeuropathy, polyneuropathy, or autonomic neuropathy

          -  Have significant allergies to humanized monoclonal antibodies
Phase I Study of OPC-61815
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Intervention: OPC-61815 16mg; OPC-61815 32mg; Moxifloxacin; Placebos
Intervention description: OPC-61815 16mg will be intravenously administered once a week.; OPC-61815 32mg will be intravenously administered once a week.; 400mg tablet will be administrated once a week.; Placebo will be intravenously administered once a week.
Intervention MeSH terms: Moxifloxacin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 48.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the effects of intravenous administration of OPC-61815 at 16 and 32 mg on
      QT/QTc interval in healthy male subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) [body weight in kg / (height in m)2] of at least 18.5 kg/m2 and
             less than 25.0 kg/m2 as a result of at the screening examination

          -  Judged by the investigator or subinvestigator to be capable of providing written
             informed consent prior to start of any trial-related procedures and capable of
             complying with the procedures for this trial

        Exclusion Criteria:

          -  Subjects with a medical history of convulsive disorder, long QT syndrome (including
             family history), syncope during swimming, or any other type of syncope or cryptogenic
             loss of consciousness

          -  Subjects with a serum electrolyte abnormality (hypokalemia, hypomagnesemia,
             hypocalcemia, etc)

          -  Subjects with a family history of sudden death
Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections
Condition: Systemic Infections
MeSH terms: Infections; Communicable Diseases; Sepsis
Intervention: CAZ-AVI
Intervention description: Single IV dose of Ceftazidime and Avibactam. Dosage regimen will vary depending on cohort.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 3 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Ceftazidime, Avibactam, Anti-Infectives

Summary:

      To assess the pharmacokinetics, safety and tolerability of a single dose of CAZ-AVI in
      children from 3 months of age to <18 years.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent will be obtained from parent(s) or other legally acceptable
             representative(s), and informed assent from patient (if age appropriate) will be
             obtained

          2. Male or female children ages ≥3 months to <18 years.

          3. Hospitalized, receiving systemic antibiotic therapy for the treatment of a suspected
             or confirmed infection, and expected to require hospitalization until after the end of
             treatment (EOT) evaluations are completed.

          4. If female and has reached menarche, or has reached Tanner stage 3 breast development
             (even if not having reached menarche), the patient is practicing appropriate birth
             control or is sexually abstinent.

          5. Likely to survive the current illness or hospitalization.

          6. Sufficient intravascular access (peripheral or central) to receive study drug.

        Exclusion Criteria:

          1. History of hypersensitivity reactions to carbapenems, cephalosporins, penicillin,
             other β-lactam antibiotics.

          2. If female, currently pregnant or breast feeding or has a positive serum β-human
             chorionic gonadotropin (β-hCG) pregnancy test.

          3. Receipt of a blood or blood component (e.g., red blood cells, fresh frozen plasma,
             platelets) transfusion during the 24-hour period before enrolment.

          4. BMI outside the range (below the 5th percentile or above the 85th percentile) for
             height, age, and weight except for children <2 years of age.

          5. Babies born prior to 37 weeks gestation (cohort 4 only).
Relative Bioavailability of 2 Fixed Dose Combinations of Empagliflozin/Metformin Compared With Single Tablets
Condition: Healthy
Intervention: Empagliflozin/Metformin XR, FDC; Empagliflozin/Metformin XR FDC; 25 mg Empagliflozin/1000 mg Metformin XR, FDC; 1 tablet Empagliflozin/2 tablets Metformin XR; 1 tablet Empagliflozin/3 tablets Metformin XR; 1 tablet Empagliflozin/2 tablets Metformin XR
Intervention description: Experimental: high dose empagliflozin/metformin XR, FDC tablet; Experimental: low dose empagliflozin/metformin XR, FDC tablet; Experimental, high dose Empagliflozin/Metformin XR,FDC Tablet; Active Comparator: 1x empagliflozin/2x metformin XR tablets; Active Comparator: 1x empagliflozin/3x metformin XR tablets; Active Comparator: 1x empagliflozin/2x metformin XR tablets
Intervention MeSH terms: Metformin; Empagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this trial is to demonstrate the relative bioavailability of 2 newly developed
      fixed dose combination (FDC) tablets containing empagliflozin & metformin and the single
      tablets of empagliflozin and metformin when administered singularly.
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy males or females

          2. Age 18-50 years (incl)

          3. Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl)

          4. Subjects must be able to understand and comply with study requirements

        Exclusion criteria:

        Any deviation from healthy condition
A Single Dose Study of LY3023703 in Healthy Participants
Condition: Healthy Volunteers
Intervention: LY3023703; Placebo; Celecoxib
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Celecoxib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a phase I study of LY3023703 in healthy participants. The purposes of this study are
      to look at safety, how well the study drug is tolerated, how much of the study drug gets into
      the blood stream, and how long it takes the body to get rid of it when given to humans.
      Information about any side effects that may occur will also be collected. Participants will
      remain in the study for approximately 3 months. This study is for research purposes only and
      is not intended to treat any medical condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy individuals based on the history and physical examinations as
             determined by the investigator

          -  Body mass index between 18.5 and 32.0 kilograms per square meter (kg/m^2), inclusive

        Exclusion Criteria:

          -  Have known allergies to LY3023703 or any components of the formulation, celecoxib, or
             sulfonamides. Participants with known aspirin allergy, allergic reaction to
             nonsteroidal anti-inflammatory drugs (NSAIDs), or allergies or intolerance to other
             selective microsomal prostaglandin E synthase (mPGES-1) inhibitors should also be
             excluded

          -  Have the presence of active peptic ulcer disease, gastrointestinal (GI) bleeding,
             chronic gastritis, inflammatory bowel disease, or chronic diarrhea, or positive
             Helicobacter pylori serology

          -  Use NSAIDs, celecoxib, aspirin, or acetaminophen (at doses greater than 1 gram per
             day) within 14 days of screening
To Assess Safety, Tolerability and Pharmacodynamics of Intravenous MEDI8111 After Single Ascending Doses.
Condition: Healthy Subjects
Intervention: MEDI8111; Placebo
Intervention description: MEDI8111 lyophilisate for solution for infusion; Placebo for MEDI8111 saline solution for infusion
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 157.0
Sex: Male
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Phase 1, healthy male subjects, safety and tolerability, pharmacodynamic, pharmacokinetic

Summary:

      A study to investigate the safety, tolerability and pharmacodynamics of MEDI8111 after single
      ascending doses in healthy male.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed and dated, written informed consent prior to any study specific
             procedures, Healthy male subjects aged 18-40 years with suitable veins for cannulation
             or repeated venepuncture, Have a body mass index (BMI) between 18 and 30 kg/m2
             inclusive and weight at least 50 kg an no more than 100 kg inclusive, Male subjects
             should be willing to avoid fathering a child by either true abstinence or the use of
             two effective means of contraception from the day of dosing until 3 months after
             dosing with the IP. They should also be willing to use barrier methods from the day of
             dosing until 3 months after dosing.

        Exclusion Criteria:

          -  Prothrombotic mutation such as factor V Leiden, or deficiencies of protein C, protein
             S, prothrombin, antithrombin or APC, Antibodies to coagulation FII, History or family
             history of venous or arterial thromboembolic event, and/or myocardial infarction
             before age of 50 years, ETP level at baseline >2000nM/min, FII level (by clot) at
             screening and/or at baseline outside 50-250% of the normal range
A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide
Condition: Obesity
MeSH terms: Obesity
Intervention: Tirzepatide; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Tirzepatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This is a study of tirzepatide in participants with obesity. The main purpose is to learn
      more about how tirzepatide affects the number of calories participants burn and the amount of
      food they eat. The study lasted for 28 weeks and will include about 21 visits to the study
      center.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have body mass index of 30 to 45 kilograms per square meter (kg/m²), inclusive

          -  Have a stable body weight in the past 1 month prior to screening

          -  Willing and agreeable to commit to the duration of the study and undergo study
             procedures as instructed by the clinic staff

        Exclusion Criteria:

          -  Have undergone gastric bypass or bariatric surgery

          -  Have a diagnosis of type 2 diabetes

          -  Have a history 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 study drug; or of interfering with the
             interpretation of data

          -  Have received prescription drugs or over the counter drugs that promote weight loss in
             the past 6 months prior to screening

          -  Have any lifetime history of a suicide attempt

          -  Patient Health Questionnaire-9 (PHQ-9) score of 15 or more at screening

          -  Positive responses to selected items on the Columbia Suicide Severity Rating Scale
             (C-SSRS)
Administration of IV Laronidase Post Bone Marrow Transplant in Hurler
Condition: Hurler Syndrome
MeSH terms: Mucopolysaccharidosis I; Syndrome
Intervention: Laronidase
Intervention description: Laronidase 0.58 mg/kg intravenously (IV) once a week for a maximum of 2 years
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Maximum age: 14 Years
Healthy volunteers: No
Keywords: mucopolysaccharide IH (MPS IH)

Summary:

      This is a single center pilot study in which Laronidase will be given weekly for two years in
      patients with Hurler syndrome, also known as mucopolysaccharide IH (MPS I, Hurler syndrome),
      that have previously been treated with an allogeneic transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mucopolysaccharidosis type IH (MPS I, Hurler syndrome) treated with a prior allogeneic
             transplant >2 years previously

          -  Age <14 years old

          -  >10% engrafted based on recent testing (<4 months prior to enrollment)

          -  Willing to commit to traveling to the University of Minnesota every 6 months

          -  Written informed consent prior to the performance of any study related procedures

        Exclusion Criteria:

          -  Previous administration of Laronidase enzyme > 3 months post transplantation

          -  Anticipated survival less than 2 years

          -  History of cardiac or pulmonary insufficiency, including an ejection fraction (EF) <
             40% or those requiring continuous supplemental oxygen
COVID-19 Convalescent Plasma for the Treatment of Hospitalized Patients With Pneumonia Caused by SARS-CoV-2.
Condition: COVID-19
MeSH terms: COVID-19; Pneumonia
Intervention: COVID-19 Convalescent Plasma
Intervention description: 2 units of COVID-19 convalescent plasma compatible with their blood type
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized 1:1 to receive either convalescent plasma on Study Day 1 in addition to standard care or standard care alone.
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Convalescent plasma

Summary:

      The purpose of this study is to see if this plasma can be safely used in humans with COVID-19
      and to see if it improves patients' health as compared to not using it in patients with
      pneumonia caused by SARS-CoV-2.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult ≥18 years of age

          2. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other authorized or
             approved assay in any specimen collected within 72 hours prior to enrollment.

             Note - An exception must be requested to the Sponsor if ≥72 hours since positive test.

          3. Hospitalized in participating facility.

          4. Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g.,
             chest x-ray or CT scan).

          5. Abnormal respiratory status that is judged worse than baseline by the investigator and
             as documented at any point within 24 hours prior to randomization, consistent with
             ordinal scale levels 5, 6 or 7, specifically defined as:

               -  Room air saturation of oxygen (SaO2) < 93%, OR

               -  Requiring supplemental oxygen, OR

               -  Tachypnea with respiratory rate ≥30

          6. Patient or proxy is willing and able to provide written informed consent and comply
             with all protocol requirements

        Exclusion Criteria:

          1. Contraindication to transfusion (e.g., severe volume overload, history of severe
             allergic reaction to blood products), as judged by the investigator.

          2. Clinical suspicion that the etiology of acute illness (acute decompensation) is
             primarily due to a condition other than COVID-19

          3. Receipt of other investigational therapy as a part of another clinical trial. Note:
             investigational therapies used as part of clinical care, (eg, remdesivir,
             hydroxychloroquine) are permissible.