bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Abuse Potential of Lasmiditan in Participants Who Are Recreational Drug Users
Condition: Recreational Drug Use; Prescription Drug Abuse (Not Dependent)
MeSH terms: Substance-Related Disorders
Intervention: Lasmiditan; Alprazolam; Placebo
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Alprazolam; Lasmiditan
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the abuse potential of study drug lasmiditan.

      Lasmiditan will be compared to a marketed benzodiazepine, alprazolam (positive control), as
      well as to placebo (dummy substance that looks like lasmiditan or alprazolam without any
      active drug) to determine the potential for drug abuse. The dosages will be in tablet form
      and will be taken orally (by mouth).

      This study will last about 55 days, including screening. Screening will occur within 28 days
      prior to qualification phase.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined by medical history and physical
             examination.

          -  Have a body mass index (BMI) of 18 to 32 kilograms per meter squared (kg/m²)
             inclusive, at the time of screening.

          -  Must be recreational drug user and agree not to consume any recreational drugs during
             the study.

        Exclusion Criteria:

          -  Have known allergies to lasmiditan, alprazolam, related compounds, or any components
             of the formulation, or a history of significant atopy.

          -  Are currently seeking or participating in treatment for addiction or substance-related
             disorders, or have recovered from substance abuse disorder.

          -  Are currently taking excluded prescription or over-the-counter (OTC) medications.

          -  Have a history of significant sleep disorder, including sleep apnea or narcolepsy.

          -  Have a history of orthostatic hypotension, vertigo, syncope, or presyncope.

          -  Have a history of brain injury, including a history of concussions.
Behavioral Effects of Drugs (Inpatient): 40 [Methamphetamine, Methylphenidate, Duloxetine]
Condition: Methamphetamine Use Disorder
Intervention: Methamphetamine; Methylphenidate; Placebo oral capsule; Duloxetine
Intervention description: In each arm, subjects will receive doses of methamphetamine.; In each arm, subjects will receive methylphenidate capsules.; In each arm, subjects will receive placebo capsules.; Subjects will receive duloxetine capsules in the duloxetine arm.
Intervention MeSH terms: Duloxetine Hydrochloride; Methylphenidate; Methamphetamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Methamphetamine; Methylphenidate; Duloxetine Hydrochloride; Central Nervous System Stimulants; Physiological Effects of Drugs; Dopamine Uptake Inhibitors; Serotonin and Noradrenaline Reuptake Inhibitors; Membrane Transport Modulators; Neurotransmitter Agents; Dopamine Agents; Molecular Mechanisms of Pharmacological Action; Sensory System Agents; Peripheral Nervous System Agents; Vasoconstrictor Agents; Antidepressive Agents; Psychotropic Drugs

Summary:

      This study will evaluate the behavioral effects of methamphetamine during maintenance on
      placebo, duloxetine, methylphenidate and duloxetine combined with methylphenidate using
      sophisticated human laboratory methods.
    

Eligibility criteria:

        Inclusion Criteria:

          -  recent use of inhaled (i.e., snorted), smoked or injected methamphetamine

        Exclusion Criteria:

          -  Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians
             deem clinically significant.

          -  Current or past histories of substance use that are deemed by the study physicians to
             interfere with study completion.

          -  History of serious physical disease, current physical disease, impaired cardiovascular
             functioning, chronic obstructive pulmonary disease, history of seizure or current or
             past histories of serious psychiatric disorder that in the opinion of the study
             physician would interfere with study participation will be excluded from
             participation.

          -  Females not currently using effective birth control.

          -  Contraindications to methamphetamine, methylphenidate, or duloxetine.
Phase 1 Single-ascending Dose Study to Evaluate Safety and Tolerability of MEDI4920 in Healthy Adults
Condition: Healthy Volunteer
Intervention: MEDI4920 3 mg; MEDI4920 10 mg; MEDI4920 30 mg; MEDI4920 100 mg; MEDI4920 300 mg; MEDI4920 1000 mg; MEDI4920 3000 mg; Placebo
Intervention description: Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.; Participants received single IV dose of MEDI4920 10 mg infused on Day 1.; Participants received single IV dose of MEDI4920 30 mg infused on Day 1.; Participants received single IV dose of MEDI4920 100 mg infused on Day 1.; Participants received single IV dose of MEDI4920 300 mg infused on Day 1.; Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.; Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.; Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Male; Healthy Female of non child bearing potential

Summary:

      Phase 1 single IV dose study to evaluate safety and tolerability of MEDI4920
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy as determined by a responsible study physician based on medical evaluation

          -  Body weight 40 to 100 kg

          -  Body mass index 19.0 to 30.0 kg/m2

        Exclusion Criteria:

          -  History of allergy or sensitivity to Shellfish or protein based antigens

          -  previous immunization with KLH

          -  previous splenectomy

          -  History of diagnosed or suspected thromboembolic event or coagulation disorder
A Study of LY900014 Formulation at Different Injection Sites in Healthy Participants
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: LY900014 (SC); LY900014 (IV)
Intervention description: Administered SC; Administered IV
Intervention MeSH terms: Insulin Lispro
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluates a new formulation of insulin lispro, LY900014, a drug that lowers blood
      sugar. It is administered by injection into the vein and under the skin of the abdomen, thigh
      and arm.

      The study will be conducted in healthy people to investigate the effect of different
      injection sites on the amount of insulin lispro in the bloodstream.

      Side effects and tolerability will be documented. The study will last for about 10 weeks for
      each participant, including screening and follow up. Screening is required within 28 days
      prior to entering the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy male or a female (not pregnant and agreeable to take birth control
             measures until study completion)

          -  Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²)

          -  Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine
             laboratory test results that are acceptable for the study

          -  Are nonsmokers, have not smoked for at least 6 months prior to entering the study

        Exclusion Criteria:

          -  Are currently participating in or completed a clinical trial within the last 30 days
             or any other type of medical research judged to be incompatible with this study

          -  Have previously participated or withdrawn from this study

          -  Had blood loss of more than 450 milliliters (mL) within the last 3 months
Vaccination With Autologous Breast Cancer Cells Engineered to Secrete Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Metastatic Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Autologous, Lethally Irradiated Breast Cancer Cells
Intervention description: Vaccine will be administered on days 1, 8, 15, 29 and then every 2 weeks until the supply of vaccine runs out
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
Keywords: autologous vaccination; GM-CSF; adenoviral mediated gene transfer; Stage IV breast cancer

Summary:

      The purpose of this trial is to test the safety of a vaccine made from a patient's own breast
      cancer cells, and determine if this vaccine will delay or stop the growth of the cancer. The
      vaccine is made by genetically modifying a patient's own tumor cells to secrete
      granulocyte-macrophage colony-stimulating factor (GM-CSF) to activate the immune response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed Stage IV breast cancer

          -  Prior banked malignant effusion or significant malignant effusion for tumor harvest or
             surgically-accessible tumor nodule of at least 2cm in greatest diameter by physical
             exam, magnetic resonance imaging (MRI) or computed tomography (CT) scan

          -  Must have received at least one prior regimen of chemotherapy for metastatic disease

          -  Patients with HER2 positive tumors must have received at least one prior
             trastuzumab-based therapy in the metastatic setting, and may not receive trastuzumab
             therapy and vaccine treatment concurrently

          -  Patients may receive concurrent bisphosphonate therapy and/or erythropoetin therapy at
             any point while on study

          -  ECOG performance status 0 or 1

          -  Estimated life expectancy of greater than or equal to 6 months

          -  18 years of age or older

          -  Greater than 4 weeks from immunotherapy, or systemic glucocorticoid therapy

          -  Adequate recovery from drug-related toxicities from prior systemic therapies

          -  Adequate recovery from recent surgery and radiation therapy

          -  Greater than 6 months since bone marrow or peripheral blood stem cell transplant

        Exclusion Criteria:

          -  Urgent need for cytotoxic chemotherapy, radiotherapy, or surgery in the next 60 days

          -  Uncontrolled active infection or illness

          -  Psychiatric illness/social situation that would limit study compliance

          -  Pregnant or nursing mothers

          -  Evidence of HIV infection

          -  Previous participation in an adenovirus-based trial

          -  Concurrent invasive malignancy
Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)
Condition: Otitis Media With Effusion in Children; Otitis Media Recurrent
MeSH terms: Otitis; Otitis Media; Otitis Media with Effusion
Intervention: EXE844 Sterile Otic Suspension, 0.3%; Tympanostomy Tube Insertion
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 6 Months
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic
      Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects,
      immediately after bilateral tympanostomy tube surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and
             eligible for bilateral myringotomy and tympanostomy tube insertion;

          -  Legally Authorized Representative (LAR) must read and sign the informed consent;

          -  Parent or caregiver must agree to complete the required study visits and comply with
             the requirements of the study;

          -  Other protocol-specified inclusion criteria may apply.

        Exclusion Criteria:

          -  Menarcheal females;

          -  Previous otologic or otologic-related surgery within the past 30 days or ongoing
             complications;

          -  Existing perforation of the eardrum;

          -  Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions
             which could interfere with evaluation of the study drug;

          -  Any systemic disease or disorder, complicating factor or structural abnormality that
             would negatively affect the conduct or outcome of the study;

          -  Use of prohibited medications or inadequate washout of any medication including
             systemic and topical antibiotics, steroids and/or analgesics;

          -  Weighs less than 8 kg;

          -  Other protocol-specified exclusion criteria may apply.
Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma
Condition: Cachexia; Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Wasting Syndrome; Cachexia
Intervention: Placebo Testosterone; Testosterone Enanthate 100 MG/ML
Intervention description: Placebo (Saline) Testosterone given IM once per week.; Testosterone Enanthate 100mg/ml given once per week IM.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: stage IIB cervical cancer; stage III cervical cancer; recurrent cervical cancer; cachexia; advanced head/neck carcinoma; recurrent head/neck carcinoma

Summary:

      RATIONALE: Testosterone may lessen weight loss and improve muscle size and strength in
      patients with cachexia caused by cancer.

      PURPOSE: This randomized phase I trial is studying whether testosterone administered during
      standard of care chemotherapy and/or radiation works by helping patients with squamous cell
      carcinoma to maintain their body weight and muscle size and strength during treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of advanced (stage IIB, IIIA, or IIIB) or recurrent squamous cell carcinoma

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Mini Mental State Examination score > 23

        Exclusion Criteria:

          -  Pregnancy

          -  Evidence of hepatitis as indicated by a 3-fold increase in 2 out of 3 liver enzymes

          -  Significant liver, renal, or heart disease

          -  Diabetes mellitus or other untreated endocrine disease

          -  Polycystic ovary syndrome and/or hyperthecosis

          -  Androgen secreting tumors of the ovary and adrenal or any ovarian tumors (e.g.,
             Sertoli- Leydig cell tumor)

          -  Non-classical adrenal hyperplasia

          -  Cushing's syndrome

          -  Glucocorticoid resistance

          -  Hyperprolactinoma or hypothyroidism

          -  Lactose intolerance

          -  Alcohol or drug abuse

          -  Recent treatment (within 3 months) with anabolic steroids

          -  Ongoing anticoagulant therapy

          -  Any other circumstance that would preclude study participation, in the opinion of the
             principal investigator or study physician
A Study of LY900014 in Participants With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro
Intervention description: Administered via SC injection; Administered via SC injection
Intervention MeSH terms: Insulin Lispro
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 6 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in
      participants with type 1 diabetes mellitus.

      There are 2 parts to this study. Part A is investigating how the body processes LY900014 and
      the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study
      treatment is given by subcutaneous injection. Part B of the study is investigating how the
      body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin
      lispro (Humalog) when study treatment is given by continuous subcutaneous insulin infusion
      (CSII) pump.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the study will last about 40 days in each part.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at
             least 1 year

          -  Have a glycated hemoglobin (HbA1c) less than (<)10.0 percent (%)

        Exclusion Criteria:

          -  Receiving any oral or injectable medication intended for the treatment of diabetes
             mellitus other than insulins in the 12 months prior to screening

          -  More than one episode of severe hypoglycaemia in the last 6 months

          -  Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or
             gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease,
             uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency

          -  Have obvious clinical signs or symptoms of liver disease

          -  Have a history of renal impairment
COVID-19 Convalescent Plasma for Mechanically Ventilated Population
Condition: Covid-19
MeSH terms: COVID-19
Intervention: COVID-19 Convalescent Plasma
Intervention description: Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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 can improve patients' health when they are sick with COVID-19.
    

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, on invasive mechanical ventilation or ECMO, consistent with a clinical
             status assessment 8-point ordinal scale severity score of 7.

          4. Documentation of pneumonia with radiographic evidence of infiltrates by imaging (e.g.,
             chest x-ray or CT scan).

          5. 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. a. Note:
             investigational therapies used as part of clinical care, (eg, remdesivir,
             hydroxychloroquine) are permissible.