bioihbjkbjnl/mcl2 huggingface dataset:
Piloting Acute Care to Primary Care Linkage of Safety Net Patients
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Intervention: Cognitive Behavioral Therapy; Motivational Interviewing; FDA-Approved Anti-Anxiety Medications; Standard Care Control
Intervention description: Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.; Motivational interviewing is designed to address alcohol and drug use.; Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care.; Standard care control includes the usual treatment for injured trauma survivors
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PTSD

Summary:

      This pilot study will evaluate the implementation of a stepped care intervention that
      combines Cognitive-Behavioral Therapy, Motivational Interviewing, psychotropic medications,
      and information technology innovations at a level 1 trauma center to community linkage
      components to reduce the symptoms of posttraumatic stress disorder and related comorbidities
      in injured trauma survivors treated in the emergency department and surgical inpatient
      settings.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English-speaking

          -  Admitted to Harborview Medical Center with injuries sufficiently severe enough to
             require inpatient admission

          -  Experienced a traumatic injury

          -  Exhibits symptoms of PTSD while in the hospital ward

          -  Low-income

        Exclusion Criteria:

          -  History of head, spinal, or other injury that may prevent participation in the ward
             interview

          -  Requires immediate intervention due to conditions such as self-inflicted injury,
             active psychosis, or active mania

          -  Currently incarcerated

          -  Likely to face criminal charges

          -  Lives outside of the state of Washington

          -  Not low-income
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
Pharmacokinetics and Safety Study of Omecamtiv Mecarbil in Healthy Japanese Adults
Condition: Healthy Volunteer
Intervention: Omecamtiv mecarbil; Placebo
Intervention description: Omecamtiv mecarbil tablets for oral administration; Matching placebo tablets
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Heart failure

Summary:

      The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability
      of omecamtiv mecarbil in healthy volunteers in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No history or evidence of clinically relevant medical disorders as determined by the
             Investigator, and in good health as determined by a pre-study physical examination and
             medical history with no clinically significant abnormalities, normal vital signs and
             no history or presence of a clinically significant abnormal electrocardiogram finding

          -  Subjects' pre-study clinical laboratory findings (including creatine phosphokinase)
             should be within normal range or if outside of the normal range, are deemed not
             clinically significant by the Investigator.

        Exclusion Criteria:

          -  A clinically significant disorder/disease, including gastro intestinal abnormalities
             that might interfere with absorption

          -  An unstable medical condition, defined as having been hospitalized within 28 days
             before day 1, major surgery within 6 months before day 1, or otherwise unstable in the
             judgment of the Investigator

          -  History or evidence of any other clinically significant disorder, condition, or
             disease that, in the opinion of the Investigator or Medical Monitor would pose a risk
             to subject safety or interfere with the study evaluation, procedures, or completion

          -  History of malignancy of any type other than surgically excised non-melanomatous skin
             cancers or in situ cervical cancer within 5 years before the day of dosing

          -  Use of any prescription or over-the-counter medications within 14 days or 5 half-lives
             (whichever time period is greater), prior to receiving the first dose of omecamtiv
             mecarbil (acetaminophen up to 2 grams per day for analgesia and hormone replacement
             therapy (e.g., estrogen) will be allowed

          -  Use of any known inhibitors of CYP3A4/p-glycoprotein (P-gp) or CYP2D6 within 14 days
             or 5 half-lives, whichever is longer; or use of grapefruit juice or grapefruit
             containing products within 7 days prior to receiving the first dose of omecamtiv
             mecarbil

          -  Use of any known CYP3A4 inducers within 30 days or 5 half-lives, whichever is longer,
             before receiving omecamtiv mecarbil
A Study of LY900014 in Participants With Type 2 Diabetes on Insulin Injection Therapy
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY900014; Insulin Lispro
Intervention description: Administered subcutaneously (SC); Administered SC
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: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The study will be conducted in participants with type 2 diabetes on insulin injection therapy
      to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar
      levels. Side effects and tolerability will be documented. The study will be conducted in two
      parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in
      both parts.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are male or female participants with Type 2 Diabetes Mellitus (T2DM) on a stable
             multiple daily injection regimen with a short-acting as well as a long-acting insulin

          -  Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter
             (kg/m²), inclusive, at screening

          -  Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory
             test results acceptable for the study

          -  Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance
             in treatment by a second party)

          -  Have venous access sufficient to allow for blood sampling

          -  Have provided written consent and are willing to follow study procedures and commit to
             the study duration

        Exclusion Criteria:

          -  Are currently enrolled, or have participated within the last 30 days, in a clinical
             trial or any other type of medical research judged to be incompatible with this study

          -  Have previously completed or withdrawn from this study

          -  Have or used to have health problems that, in the opinion of the doctor, could make it
             unsafe to participate in the study

          -  Had blood loss of more than 500 milliliters (mL) within the last month

          -  Are treated with a continuous subcutaneous insulin infusion (insulin pump)
Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Condition: Attention-Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Lisdexamfetamine Dimesylate (LDX); Immediate Release Mixed Amphetamine Salts (MAS-IR); LDX Placebo + MAS-IR Placebo
Intervention description: Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo; Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo; Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo
Intervention MeSH terms: Amphetamine; Lisdexamfetamine Dimesylate
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: ADHD

Summary:

      To evaluate the sensitivity and responsiveness of a standardized, validated, computer-based,
      battery of neuro-psychometric tests in adults with ADHD.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subject meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition;
             Text Revision (DSM IV TR) criteria for a primary diagnosis of ADHD (diagnostic code
             314.00 and 314.01) established by a comprehensive psychiatric evaluation that reviews
             DSM-IV-TR criteria with at least 6 of the 9 subtype criteria met.

          2. Subject has been previously treated for ADHD with an adequate course of amphetamine
             therapy with no history of intolerance, or lack of efficacy, as determined by the
             Investigator.

          3. Subject does not have any physical disability (eg. colorblindness, limitations with
             use of one or both hands, etc) that would interfere with the subject's participation
             in or performance on any of the neuropsychometric tests. For a number of these tasks
             speed is a key factor thus subjects cannot have any obvious impediments/impairments in
             the use of their hands.
Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: BIA 2-093; S-licarbazepine; R-licarbazepine
Intervention description: Tablets containing 900 mg; capsules containing 225 mg; capsules containing 225 mg
Intervention MeSH terms: Eslicarbazepine acetate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Single centre, open-label, randomised study in four parallel groups of healthy volunteers
    

Eligibility criteria:

        Inclusion Criteria

          -  Male or female subjects aged between 18 and 45 years, inclusive.

          -  Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.

          -  Subjects who were healthy as determined by pre-study medical history, physical
             examination, vital signs, neurological examination, and 12-lead ECG.

          -  Subjects who had clinical laboratory tests clinically acceptable at screening and
             admission.

          -  Subjects who had negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at
             screening.

          -  Subjects who were negative for drugs of abuse and alcohol at screening and admission.

          -  Subjects who were non-smokers or who smoke < 10 cigarettes or equivalent per day.

          -  Subjects who are able and willing to give written informed consent.

          -  (If female) She was not of childbearing potential by reason of surgery or, if of
             childbearing potential, she used one of the following methods of contraception: double
             barrier, intrauterine device or abstinence.

          -  (If female) She had a negative pregnancy test at screening and admission to Phase A.

        Exclusion Criteria:

          -  Subjects who did not conform to the above inclusion criteria, OR

          -  Subjects who had a clinically relevant history or presence of respiratory,
             gastrointestinal, renal, hepatic, haematological, lymphatic, neurological,
             cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological,
             dermatological, endocrine, connective tissue diseases or disorders.

          -  Subjects who had a clinically relevant surgical history.

          -  Subjects who had a clinically relevant family history.

          -  Subjects who had a history of relevant atopy.

          -  Subjects who had a history of relevant drug hypersensitivity (especially carbamazepine
             or oxcarbazepine).

          -  Subjects who had a history of alcoholism or drug abuse.

          -  Subjects who consumed more than 14 units of alcohol a week.

          -  Subjects who had a significant infection or known inflammatory process on screening or
             admission.
Epidural Neostigmine for Labor Pain
Condition: Labor Pain
MeSH terms: Labor Pain
Intervention: Neostigmine; Bupivacaine; fentanyl
Intervention description: utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.; fentanyl 2 mcg/ml
Intervention MeSH terms: Fentanyl; Bupivacaine; Neostigmine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 200.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: non narcotic; epidural; labor pain; Non narcotic treatment of labor pain

Summary:

      The purpose of this study is to see which dose of epidural neostigmine is the best additive
      to use with the numbing medication used in an epidural during labor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy pregnancy

          -  Term pregnancy ( > 37 weeks)

          -  Primiparous or multiparous

          -  Induction or spontaneous labor greater or = 18 years of age

          -  Cervical exam on entry </=5 cm

        Exclusion Criteria:

          -  Weight > 115 kg

          -  Non-English speaking

          -  IV analgesics within 60 minutes prior to epidural being administered

          -  Allergy to local anesthetics or neostigmine
Fed Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Tablets
Condition: Healthy; Therapeutic Equivalency
Intervention: Zolpidem Tartrate 10 mg tablet; Zolpidem Tartrate 10 mg tablet (Ambien®)
Intervention description: 10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.; 10 mg tablet administered following an overnight fast of at least 10 hours and a standardized, high fat breakfast.
Intervention MeSH terms: Zolpidem
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem
      tartrate tablets to an equivalent oral dose of the commercially available Ambien® (zolpidem
      tartrate tablets)in adult subjects under fed conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sex: Male or Female; similar proportions of each preferred

          -  Age: At least 18 years

          -  Weight: must be 15% of ideal weight for height and frame

          -  Subjects must be in good health and physical condition as determined by medical
             history

          -  Subjects must read and sign the Consent Form

        Exclusion Criteria:

          -  history of treatment for alcoholism, substance abuse, or drug abuse within past 24
             months

          -  history of malignancy, stroke, diabetes, cardiac, renal or liver disease

          -  history of GERD, malabsorption syndrome, colon cancer, or chronic colitis, including
             Crohn's disease

          -  history of treatment for asthma within the past five (5) years

          -  history of mental depression, pulmonary disease, sleep apnea

          -  females who are pregnant or lactating

          -  history of hypersensitivity to zolpidem tartrate, or any hypnotic or sedative

          -  conditions upon screening which might contraindicate or require that caution be used
             in the administration of zolpidem tartrate, including sitting systolic blood pressure
             below 90 mm Hg, or diastolic pressure below 50 mm Hg; heart rate less than 50 beats
             per minute after a 5-minute rest in a seated position

          -  inability to read and/or sign the consent form

          -  treatment with any other investigation drug during the four (4) weeks prior to the
             initial dosing for this study

          -  subjects who have donated blood within four (4) weeks prior to the initial dosing for
             this study

          -  subjects who smoke or use tobacco products or are currently using nicotine products
             (patches, gums, etc.) Three (3) months abstinence is required.
A Pharmacokinetic/Pharmacodynamic Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: RO5185426; RO5185426; RO5185426; RO5185426; RO5185426
Intervention description: dosage b) orally twice daily, days 1-15 (morning dose); dosage c) orally twice daily, days 1-15 (morning dose); dosage d) orally twice daily, days 1-15 (morning dose); 960 mg orally twice daily, from day 22 onward; dosage a) orally twice daily, days 1-15 (morning dose)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label study will assess the pharmacokinetics, efficacy and safety of RO5185426
      administered as 240mg tablets in previously treated patients with metastatic melanoma.
      Patients will be randomized to receive one of four dose-levels of RO5185426 [RG7204;
      PLEXXIKON; PLX4032] orally twice daily on days 1 to 15 (morning dose). Starting on day 22,
      treatment with RO5185426 may be resumed at a dose of 960 mg twice daily and continued until
      disease progression. Target sample size is <100 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >/=18 years of age

          -  histologically confirmed metastatic melanoma, stage IIIc or IV (AJCC)

          -  failure of at least one prior standard of care regimen

          -  positive for BRAF V600E mutation (by Roche CoDx BRAF mutation assay)

          -  ECOG performance status 0 or 1

          -  adequate hematologic, renal and liver function

        Exclusion Criteria:

          -  active CNS lesions on CT/MRI within 28 days prior to enrollment

          -  history of spinal cord compression o carcinomatous meningitis

          -  anticipated or ongoing anti-cancer therapies other than those administered in this
             study

          -  previous treatment with BRAF inhibitor (sorafenib allowed) or MEK inhibitor

          -  severe cardiovascular disease within 6 months prior to study

          -  previous malignancy within the past 5 years except for basal or squamous cell
             carcinoma of the skin, melanoma in-situ and carcinoma in-situ of the cervix