bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Effects of Rifampin on Pharmacokinetics (PK) of Pevonedistat in Participants With Advanced Solid Tumors
Condition: Advanced Solid Neoplasm
Intervention: Pevonedistat; Rifampin; Docetaxel; Carboplatin; Paclitaxel
Intervention description: Pevonedistat intravenous infusion.; Rifampin capsules.; Docetaxel intravenous infusion.; Carboplatin intravenous infusion.; Paclitaxel intravenous infusion.
Intervention MeSH terms: Rifampin; Paclitaxel; Docetaxel; Carboplatin; Pevonedistat
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to assess the effect of multiple-dose administration of rifampin
      on the single dose PK of pevonedistat in adult participants with advanced solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult participants who have a histologically or cytologically confirmed metastatic or
             locally advanced solid tumor that is appropriate for treatment with either docetaxel
             or carboplatin + paclitaxel in Part B of this study, or have progressed despite
             standard therapy, or for whom conventional therapy is not considered effective.

          2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

          3. Expected survival of at least 3 months from the date of enrollment in the study.

          4. Recovered (that is, less than or equal to (<=) Grade 1 toxicity) from the effects of
             prior antineoplastic therapy.

          5. Adequate organ functions (kidney, liver, cardiac, bone marrow).

          6. Suitable venous access for the study-required blood sampling (including PK sampling).

        Exclusion Criteria:

          1. Prior treatment with radiation therapy involving greater than or equal to (>=) 25% of
             the hematopoietically active bone marrow.

          2. Life-threatening illness or serious (acute or chronic) medical or psychiatric illness
             unrelated to cancer.

          3. Active, uncontrolled infection or severe infectious disease.

          4. Known human immunodeficiency virus (HIV) seropositive or known hepatitis B or
             hepatitis C infection.

          5. With significant heart or pulmonary disease.

          6. Requiring chronic treatment with breast cancer resistance protein (BCRP) inhibitors.

        Criteria for Continuation into Optional Part B:

        To be eligible for Part B, participants must have completed Part A and be reassessed to
        determine if they meet the continuation criteria for Part B.
Improving Rehabilitation by Magnetic Brain Stimulation
Condition: Stroke
MeSH terms: Stroke
Intervention: Repetitive Transcranial Magnetic Stimulation
Intervention description: We will position a coil over the motor cortex of the head and give a series of stimulations (called magnetic pulses).
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cerebrovascular Accident; rehabilitation

Summary:

      We hope to understand the properties of the motor cortex in the brain of people with stroke
      using non-invasive magnetic stimulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  3-24 months post stroke

          -  upper limb paresis

          -  CES-D below 16,

        Exclusion Criteria:

          -  history of seizure

          -  metal in head

          -  score of less than 24 on the Folstein Mini-Mental Status Exam

          -  clinical judgement of excessive frailty or lack of stamina (e.g. cannot attend to
             instructions, stay awake, engage in functional activities)

          -  serious uncontrolled medical condition

          -  excessive pain in any joint of the more affected extremity that could limit ability to
             cooperate with the intervention as judged by the examining clinician
A Study of LY3015014 in Healthy Participants With High Cholesterol
Condition: Healthy Volunteers; Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: LY3015014; Placebo
Intervention description: Administered SQ; Administered SQ
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study in healthy participants with high levels of "bad" cholesterol who are already
      taking a popular type of cholesterol-lowering medication called statins. Following multiple
      doses of LY3015014, investigators will study the safety and tolerability of the drug, how the
      body handles the drug, and the drug's effect on the body. Participants will remain in the
      study for about 3 months, not including screening. Screening is required within 28 days
      before the study starts.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be healthy males or females without childbearing potential as
             determined by medical history and physical examination

          -  Have body mass indexes of 18 to 35 kilograms per square meter (kg/m^2), inclusive, at
             screening

          -  Have screening low density lipoprotein-C (LDL-C) of between 100 and 180 milligrams per
             deciliter (mg/dL), inclusive, while having taken a stable dose of statin

        Exclusion Criteria:

          -  Have known allergies to compounds related to LY3015014 or any components of the
             formulation or known clinically significant hypersensitivity to biologic agents

          -  Have a history of atopy, significant allergies to humanized monoclonal antibodies,
             clinically significant multiple or severe drug allergies, intolerance to topical
             corticosteroids, or severe post treatment hypersensitivity reactions [including but
             not limited to erythema multiforme major, linear immunoglobulin A (IgA) dermatosis,
             toxic epidermal necrolysis, or exfoliative dermatitis]

          -  Have significant history of or current cardiovascular (excluding controlled
             hypertension), 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 medication, or of interfering with the interpretation of data

          -  Have received any vaccine(s) within 1 month of LY3015014 dosing or intend to do so
             during the study

          -  Have received treatment with biologic agents (such as monoclonal antibodies) within 3
             months or 5 half-lives (whichever is longer) prior to dosing
Study of CGC-11047 (PG-11047) in Subjects With Advanced Refractory Solid Tumors
Condition: Cancer
Intervention: PG-11047
Intervention description: PG-11047 will be administered as a 60-minute intravenous infusion on days 1, 8 and 15 of each 28 day cycle. A treatment cycle will be defined as 4 weeks of therapy. The planned minimum treatment schedule is 2 cycles of PG-11047 treatment (8 weeks).
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer; advanced cancer; solid tumors; CGC-11047; PG-11047

Summary:

      This phase I study aims to assess the safety and tolerability of a new drug - PG-11047 - and
      to establish what happens to the drug once inside the body. An escalating dose of PG-11047
      will be investigated in this study and the maximum tolerated dose of the drug will be
      established.
    

Eligibility criteria:

        Inclusion Criteria:

          -  non-hematological malignancy where standard therapeutic measures do not exist or no
             longer effective.

          -  ECOG - 0-2.

          -  Life expectancy > 3 months.

        Exclusion Criteria:

          -  chemotherapy or radiotherapy within 4 weeks prior to entering the study.

          -  previous high-dose chemotherapy with autologous allogeneic hematopoietic stem cell
             transplantation.

          -  primary brain tumors or active brain metastases

          -  history of significant or symptomatic cardiac arrhythmia, prior myocardial infarction
             or evidence of a current significant ventricular conduction abnormality
Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (MK-8237-008)
Condition: Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Nonseasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: MK-8237 6 DU; MK-8237 12 DU; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 195.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety of two doses (6 Development Units [DU]
      and 12 DU) of MK-8237 sublingual tablets compared to Placebo in adolescents with house dust
      mite-induced allergic rhinitis/rhinoconjunctivitis. The primary hypothesis is that at least
      one dose of MK-8237 sublingual tablet is safe and well-tolerated in adolescents with house
      dust mite-induced allergic rhinitis/rhinoconjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of physician-diagnosed allergic rhinitis/rhinoconjunctivitis to house dust of
             at least 6 months duration (with or without asthma)

          -  History of controlled asthma for the prior 1 month if participant has asthma, defined
             by not exceeding 2 days of symptoms per week; not more than 2 days of albuterol/short
             acting beta-agonist [SABA] use per week; and not wakening more than twice a month at
             night due to asthma symptoms

          -  Agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of
             birth control from screening and through the duration of the study

        Exclusion Criteria:

          -  Unable to meet medication washout requirements

          -  History of chronic urticaria and/or chronic angioedema within prior 2 years

          -  History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy due to
             an unknown cause or to an inhalant allergen

          -  Unstable, uncontrolled or severe asthma, or has experienced a life-threatening asthma
             attack or an occurrence of any clinical deterioration of asthma that resulted in
             emergency treatment, hospitalization due to asthma, or treatment with systemic
             corticosteroids (but allowing SABAs) at any time within prior 3 months

          -  History of chronic sinusitis during within prior 2 years

          -  Pregnant or breast-feeding, or expecting to conceive within the projected duration of
             the study

          -  Known history of allergy, hypersensitivity or intolerance to investigational medicinal
             products except for Dermatophagoides pteronyssinus (D. pteronyssinus) and/or
             Dermatophagoides farina (D. farina) or self-injectable epinephrine

          -  Business or personal relationship with investigational site personnel or Sponsor who
             is directly involved with the conduct of the trial
Dose Escalation Trial of Nitroglycerin, 5-flourouracil and Rad Therapy for Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Intervention: Nitroglycerin 0.2 MG/HR; Nitroglycerin 0.4 MG/HR; Nitroglycerin 0.6 MG/HR
Intervention description: 0.2mg/hr nitroglycerin transdermal patch daily. The first 3 patients will have a low dose patch applied (0.2 mg/hr).; 0.4mg/hr nitroglycerin transdermal patch daily. The first 3 patients will have a low dose patch applied (0.2 mg/hr) if this is well tolerated a higher dose patch (0.4mg/hr) will be used for the next 3 patients.; 0.6mg/hr nitroglycerin transdermal patch daily. The first 3 patients will have a low dose patch applied (0.2 mg/hr) if this is well tolerated a higher dose patch (0.4mg/hr) will be used for the next 3 patients and if this is well tolerated an even higher dose patch (0.6mg/hr) will be used.
Intervention MeSH terms: Nitroglycerin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: nitroglycerin; 5-flourouracil; radiation therapy; neo-adjuvant treatment

Summary:

      The purpose of this study is to determine whether topical nitroglycerin in addition to
      5-flourouracil and radiation therapy are effective in the treatment of operable rectal
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Biopsy proven Rectal Adenocarcinoma

          -  Histological diagnosis of operable T3-4, or T1-4 node positive, M0 rectal
             adenocarcinoma using endorectal ultrasound and/or MRI in addition to Computed
             Tomography (CT) of the chest, abdomen and pelvis for pre-study staging Acceptable
             alternatives for systemic staging instead of CT chest , abdomen, pelvis are CT abdomen
             and pelvis plus a Chest X-ray or a PET/CT

          -  Ability to give informed consent and willingness to adhere to study protocol

          -  Age ≥ 18 years and otherwise eligible to receive medical care at the Dallas VA Medical
             Center.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

          -  Adequate hematological, hepatic and renal function defined as in protocol.

        Exclusion Criteria:

          -  Any condition that would hamper informed consent or ability to comply with the study
             protocol

          -  Significant history of cardiac disease, e.g. uncontrolled hypertension, unstable
             angina, decompensated congestive-heart failure, myocardial infarction within the last
             six months or ventricular arrhythmias requiring medication.

          -  Pregnant and lactating women.

          -  Patients taking Phosphodiesterase - 5 inhibitors (e.g. Sildenafil, Vardenafil or
             Tadalafil) and is unable to stop for the duration of the chemoradiotherapy.
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects
Condition: Healthy
Intervention: SB3; EU sourced Herceptin®; US sourced Herceptin®
Intervention MeSH terms: Trastuzumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 109.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics

Summary:

      The purpose of this study is to compare the pharmacokinetics, safety, tolerability and
      immunogenicity of SB3 and Herceptin® (EU sourced Herceptin® and US sourced Herceptin®) in
      healthy male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects

          -  Have a body weight between 60.0 and 94.9 kg and a body mass index between 18.0 and
             29.9 kg/m², inclusive.

        Exclusion Criteria:

          -  history of and/or current clinically significant gastrointestinal, renal, hepatic,
             cardiovascular, haematological (including pancytopenia, aplastic anaemia or blood
             dyscrasia), pulmonary, neurologic, metabolic (including known diabetes mellitus),
             psychiatric or significant allergic disease excluding mild asymptomatic allergies.

          -  history of and/or current cardiac disease

          -  previously received any monoclonal antibody or fusion protein.

          -  history of cancer including lymphoma, leukaemia and skin cancer.

          -  Have received live vaccine(s) within 30 days prior to Screening or who will require a
             vaccine(s) between Screening and the End of Study visit.

          -  intake medication with a half-life > 24 h within 1 month or 10 half-lives of the
             medication prior to the administration of investigational product.
To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
Condition: Healthy
Intervention: CT-P39; EU-approved Xolair; CT-P39; EU-approved Xolair; US-licensed Xolair
Intervention description: 150 mg/mL, Solution for injection in PFS; 150 mg/mL, Solution for injection in PFS; 150 mg/mL, Solution for injection in PFS; 150 mg/mL, Solution for injection in PFS; 150 mg/mL, Solution for injection in PFS
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 176.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare
      the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved
      Xolair, and US-licensed Xolair) in Healthy Subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subject (male or female) between the ages of 18 and 55 years.

          -  Subject with a body weight of > 40 kg and ≤ 90 kg and a BMI between 18.0 kg/m2 and
             32.0 kg/m2(both inclusive).

          -  Subject with a total IgE level of ≤ 100 IU/mL.

        Exclusion Criteria:

          -  Subject has a medical history and/or current presence of disease including one or more
             of the allergic reaction.
Repetitive Transcranial Magnetic Stimulation for the Treatment of Focal Hand Dystonia
Condition: Dystonia, Focal, Task-specific
MeSH terms: Dystonia; Dystonic Disorders
Intervention: rTMS; Sham rTMS
Intervention description: rTMS; Sham rTMS
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: focal hand dystonia; rehabilitation; rTMS; writer's cramp; clinical

Summary:

      This study investigated the short term effects of repeated administrations of
      repetitive-transcranial magnetic stimulation (rTMS) on clinical changes and investigate
      neurophysiologic responses to rTMS of the activated motor system in patients with FHD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Task specific Focal Hand Dystonia

        Exclusion Criteria:

          -  any neurologic condition other than FHD

          -  medication for dystonia

          -  botulinum toxin within the past three months

          -  seizure history

          -  pregnancy

          -  implanted medical devices
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