bioihbjkbjnl/mcl2 huggingface dataset:
Preventing Depression in the Children of Depressed African American Mothers
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Prevention Intervention Project; Psychoeducation
Intervention description: Eight 1-hour sessions focused on psychoeducation, coping with stress, and cognitive-behavioral strategies. The sessions were tailored as required to meet the clinical and cultural needs of each family; other family members, such as fathers, spouses, and grandparents, were invited to participate in the intervention.; Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 8 Years
Maximum age: 14 Years
Healthy volunteers: No
Keywords: African American Mothers; Children; African American Families; Parental Depression; Preventive Intervention

Summary:

      The purpose of the study is to adapt and test the Preventive Intervention Project for urban
      African American mothers with depression and their children.
    

Eligibility criteria:

        Mothers:

        Inclusion Criteria:

          -  African American

          -  Primary current or past-year diagnostic and statistical manual (DSM-IV) diagnosis of
             Major Depressive Disorder, Dysthymic Disorder, or Depressive Disorder not otherwise
             specified

          -  Parent or guardian and primary caregiver of a child 8 to 14 years old

          -  Resided at least part time for the past year with the targeted child

          -  May be receiving psychopharmacological treatment, psychosocial services, or both

        Exclusion Criteria:

          -  Current or lifetime history of schizophrenia

          -  Current or lifetime history of bipolar disorder

          -  Current or past-year diagnosis of alcohol or drug dependency

          -  Serious medical disorder, neurological disorder, condition, or chronic pain that
             prevents participation

          -  Documented mental retardation

          -  Current suicide risk sufficient to preclude outpatient treatment

        Children:

        Inclusion Criteria:

          -  Have an African American mother with a depressive disorder

          -  8 to 14 years old

          -  Reside at least part time with mother

        Exclusion Criteria:

          -  Currently in treatment for depression or an anxiety disorder

          -  Presence of a medical or psychiatric condition contraindicating study intervention,
             such as mental retardation, suicidality, or pervasive developmental disorder
Flortaucipir PET Imaging in the Preclinical, Prodromal and Dementia Phases of Alzheimer's Disease
Condition: Alzheimer Disease; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Dementia; Cognitive Dysfunction
Intervention: Flortaucipir F18; Brain PET scan
Intervention description: IV injection, 240 megabecquerel (MBq) (6.5 mCi); positron emission tomography (PET) scan of the brain
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 89.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Phase 1 study designed to evaluate imaging characteristics of flortaucipir in the
      preclinical, prodromal and dementia phases of Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet all inclusion criteria for the AIBL study protocol, with amyloid PET conducted or
             planned and MRI available

          -  Subjects in the MCI and AD groups required to have a reliable caregiver capable of
             providing information about the subjects' symptoms

        Exclusion Criteria:

          -  lifetime history of schizophrenia, schizoaffective disorder, or bipolar disorder

          -  history of electroconvulsive therapy

          -  MRI contraindicated

          -  claustrophobic or, otherwise, unable to tolerate the imaging procedure

          -  current clinically significant cardiovascular disease or clinically significant
             abnormalities on screening electrocardiogram

          -  history of additional risk factors for Torsades de Pointes

          -  current clinically significant infectious disease, endocrine or metabolic disease, or
             pulmonary, renal, or hepatic impairment that the investigator believes would affect
             study participation

          -  history of cancer (other than skin or in situ prostate cancer) within the previous 5
             years

          -  current drug or alcohol abuse/dependence

          -  history of alcohol abuse/dependence with 2 years of the onset of the symptoms of
             dementia

          -  females of childbearing potential who were not surgically sterile, not refraining from
             sexual activity, or not using reliable methods of contraception
Evaluation of TAK-058 and Ondansetron on P50 Auditory Gating in Participants With Stable Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: TAK-058; Ondansetron; TAK-058 Placebo; Ondansetron Placebo
Intervention description: TAK-058 oral solution.; Ondansetron capsule.; TAK-058 placebo-matching, solution.; Ondansetron placebo-matching, capsule.
Intervention MeSH terms: Ondansetron
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to determine whether improvement in P50 (a pharmacodynamic
      marker) in auditory sensory gating is demonstrated after administration of TAK-058 and
      ondansetron compared to placebo in participants with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 18 to 60 years of healthy and schizophrenic participants, inclusive, at the time of
             informed consent.

          2. Has acceptable clinical laboratory evaluations (including clinical chemistry,
             hematology and complete urinalysis).

          3. Meets schizophrenia criteria as defined by the Diagnostic & Statistical Manual of
             Mental Disorders, 5th Edition (DSM-V).

          4. Are on a stable dose of single second-generation antipsychotics (SGA) for at least 2
             months prior to Screening as documented by medical history and assessed by site staff.

          5. Demonstrates Positive and Negative Syndrome Scale (PANSS) total score of less than
             equal to (<=) 85.

          6. Has a P50 ratio of > 0.5 at both screening assessments.

        Exclusion Criteria:

          1. Has a history in the last year or currently receiving treatment with clozapine or
             olanzapine.

          2. Has taken any excluded medications, supplements or food products.

          3. Has a history of gastrointestinal disease that would influence the absorption of study
             drug or have a significant medical history of any disease that would contraindicate
             the administration of TAK-058, ondansetron, or a similar compound.

          4. Has substance abuse or dependence within previous 12 months, unstable mood or anxiety
             disorder.

          5. Has a current diagnosis of a significant psychiatric illness other than schizophrenia
             per DSM-V and is in an acute phase/episode.

          6. Has clinically meaningful hearing loss per investigator's judgment.
Drug-drug Interaction of Empagliflozin (BI 10773) and Microgynon
Condition: Healthy
Intervention: levonorgestrel; levonorgestrel; Ethinylestradiol; Microgynon + BI 10773; Ethinylestradiol
Intervention description: multiple doses; multiple doses; multiple doses; multiple doses BI 10773; multiple doses
Intervention MeSH terms: Empagliflozin; Levonorgestrel; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Female
Minimum age: 18 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this study is to investigate the possible effect of multiple oral doses of
      25 mg BI 10773 on the steady state pharmacokinetics of ethinylestradiol (EE) and
      levonogestrel (LNG) (Microgynon®).
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy female subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
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.
Pharmacokinetics of CLG561 in Patients With Advanced Age-Related Macular Degeneration
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: CLG561
Intervention description: Administered by intravitreal injection, Day 1
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: First in human; Safety; Tolerability; Serum PK; Intravitreal (IVT); Age-related macular degeneration; AMD; Geographic Atrophy; Choroidal neovascularization

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and serum pharmacokinetics
      of CLG561 in subjects with advanced age-related macular degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of age-related macular degeneration in study eye, as specified in protocol.

          -  Poor visual acuity in study eye, as specified in protocol.

          -  Willing to receive meningitis and pneumonia vaccinations at least 2 weeks prior to
             study treatment.

          -  Females must be post-menopausal and/or surgically sterile.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Treatments to the study eye within 28 days prior to study treatment, as specified in
             protocol.

          -  Any disease or medication expected to cause systemic or ocular immunosuppression.

          -  Participation in another interventional clinical study or use of any experimental
             treatment for AMD within 12 weeks prior to study treatment.

          -  Other protocol-defined exclusion criteria may apply.
Safety and Blood Level Study of Unit Dose Budesonide
Condition: Asthma
MeSH terms: Asthma
Intervention: Budesonide Inhalation Suspension; MAP0010 low dose; MAP0010 intermediate dose; MAP0010 high dose
Intervention description: Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.; Treatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.; Treatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.; Treatment D = a single dose of MAP0010 (unit dose budesonide) high dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Intervention MeSH terms: Budesonide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pediatric asthma

Summary:

      The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses
      of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy
      volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adult volunteers, aged 18-50 years

          -  BMI less than 30 kg/m2

          -  Non smoker (currently and <10 pack years total if ex-smoker)

        Exclusion Criteria:

          -  Any use of corticosteroid in previous 4 weeks

          -  Pregnancy/lactation

          -  Significant blood donation (or testing) in previous 8 weeks
Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Herceptin; Sunitinib; Taxotere
Intervention description: Trastuzumab will be administered intravenously on Day 1 before docetaxel - loading dose of 4 mg/kg over 90-minute on Day 1 followed by weekly maintenance doses of 2 mg/kg on Days 1, 8, 15 given as 30-minute infusions if the initial loading dose was well tolerated. Loading dose of 8 mg/kg over 90-minute on Day 1 followed by 3-weekly maintenance doses of 6 mg/kg given as 90-minute infusions. The administration of 6 mg/kg will be repeated on Day 1 every 3 weeks.; SU011248 will be administered at 37.5 mg once daily for 2 weeks every 3 weeks (Schedule 2/1) starting from Day 2, when in combination with docetaxel. SU011248 will be administered at the starting dose of 37.5 mg daily in a continuous regimen when docetaxel is discontinued.; The starting dose of docetaxel will be 75 mg/m2 every 3 weeks, administered on Day 1 of each cycle as a 1-hour IV infusion.
Intervention MeSH terms: Docetaxel; Trastuzumab; Sunitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer over-expressing HER2. First-line treatment with sunitinib/docetaxel/trastuzumab.

Summary:

      This is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity
      of SU011248 combined with docetaxel and trastuzumab in patients with locally recurrent or
      metastatic breast cancer over-expressing Her-2, who have not received chemotherapy treatment
      in the advanced disease setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.

          -  Tumors over-expressing Her-2

          -  Candidate for treatment with docetaxel/trastuzumab

        Exclusion Criteria:

          -  Histology of inflammatory carcinoma

          -  AST and/or ALT >1.5 x ULN concomitant with ALP >2.5 x ULN
A Study In Patients With Advanced Solid Tumor
Condition: Neoplasms
Intervention: Axitinib (AG-013736)
Intervention description: Three single dose level of AG-013736 (5 mg, 7 mg and 10 mg) will be given for all patient. After single dosing at each dose level, multiple doses of 5 mg twice a day (BID) will be started.
Intervention MeSH terms: Axitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: solid tumor; Axitinib; Pharmacokinetics; Phase 1

Summary:

      This study designed to evaluate the pharmacokinetics and safety of AG-013736 at single doses
      and multiple doses
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients histologically or cytologically diagnosed with advanced solid tumors

          -  Patients for whom standard therapies have not been effective, or for whom there are no
             suitable therapies

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2

          -  Patients with no uncontrolled hypertension

        Exclusion Criteria:

          -  Patients who have central lung lesions involving major blood vessels

          -  Patients who require anticoagulant therapy.

          -  Patients with active epilepsy seizure or symptoms, with brain metastases requiring
             treatment, with spinal cord compression and with carcinomatous meningitis.
A Study of Absorption, Metabolism, Excretion and Mass Balance After a Single Dose Administration of MK-0941 (MK-0941-016)(COMPLETED)
Condition: Type 2 Diabetes
Intervention: MK-0941
Intervention description: A single dose of 40 mg of [14C]MK-0941 (160 µCi), taken orally as eight 5-mg capsules
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A single dose, open label study to characterize the routes of elimination and determine the
      mass balance of MK-0941. A single 40 mg dose of MK-0941 will be given orally to male
      participants with type 2 diabetes. After drug administration, blood, urine, and fecal samples
      will be collected to determine relative quantities of 14C-labeled MK-0941.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has been diagnosed with type 2 diabetes, and is being treated with diet and
             exercise or with an oral anti-hyperglycemic agent

          -  Subject is willing to follow the American Heart Association diet and exercise program
             throughout the study

          -  Subject is a nonsmoker and/or has not used nicotine products for at least 6 months

        Exclusion Criteria:

          -  Subject has a history of stroke, seizures, or major neurological disorder

          -  Subject has a history of neoplastic disease

          -  Subject has recently had abnormal bowel habits, such as diarrhea, loose stools or
             constipation

          -  Subject has a history of type 1 diabetes mellitus

          -  Subject has received insulin within the past 12 weeks

          -  Subject has a recent history of eye infection

          -  Subject has been diagnosed with glaucoma or is blind

          -  Subject consumes more than 3 alcoholic beverages per day

          -  Subject consumes more than 6 servings of coffee, tea, cola per day

          -  Subject has had major surgery, donated or lost blood in the past 4 weeks

          -  Subject has multiple or severe allergies to any food or drugs
A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants
Condition: Healthy
Intervention: Ixekizumab; Boostrix®; Pneumovax®23
Intervention description: Administered by SQ injection; Administered by IM injection; Administered by IM injection
Intervention MeSH terms: Ixekizumab; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the body's immune response when vaccines are given
      alone versus when vaccines are given along with the study drug called ixekizumab. The
      vaccines protect against pneumonia and tetanus. This study will last about 6 weeks with
      follow-up at 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males and females without compromised immune system

          -  Have a body mass Index of 18 to 32 kilograms per square meter (kg/m²)

        Exclusion Criteria:

          -  Previously completed or withdrawn from an ixekizumab study or a study investigating
             interleukin-17 (IL-17) antagonists

          -  Have participated, within the last 30 days, in a clinical trial involving an
             investigational product. If the previous investigational product has a long half-life,
             3 months or 5 half-lives (whichever is longer) should have passed

          -  Have known allergy or hypersensitivity to any biologic therapy

          -  Past vaccination allergy or Arthus-type hypersensitivity

          -  Received a tetanus toxoid-containing vaccine within the last 5 years

          -  Severe allergic reaction to Boostrix

          -  Allergic to latex

          -  Have been immunized with pneumococcal vaccine

          -  Known hypogammaglobulinemia

          -  History of Guillain-Barre Syndrome

          -  Active infectious disease

          -  Had a live vaccination within 1 year prior to screening, or intend to have a live
             vaccination during the course of the study

          -  Evidence of a significant uncontrolled neuropsychiatric disorder -

          -  Have a score of 3 on Item 12 of the Quick Inventory of Depressive Symptomatology-Self
             Report (16 Items) at screening

          -  Evidence of Human Immunodeficiency Virus infection, Hepatitis C, B

          -  Had symptomatic herpes zoster within 3 months of screening

          -  Women who are lactating