bioihbjkbjnl/mcl2 huggingface dataset:
Flortaucipir PET Imaging in Subjects With FTD
Condition: Frontotemporal Dementia
MeSH terms: Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
Intervention: Flortaucipir F18; Brain PET scan
Intervention description: 370 megabecquerel (MBq)(10 millicurie [mCi]) injection, single dose; positron emission tomography (PET) scan of the brain
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to assess the usefulness of flortaucipir in Positron Emission
      Tomography (PET) imaging for subjects diagnosed with Frontotemporal Dementia (FTD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects diagnosed by a dementia specialist with symptomatic clinical syndromes with
             expected Frontotemporal Dementia (FTD) pathology will be enrolled. Clinical syndromes
             associated with FTD pathology include: behavioral-variant FTD, FTD with motor-neuron
             disease, non-fluent/agrammatic and semantic variants of primary progressive aphasia,
             progressive supranuclear palsy syndrome and corticobasal syndrome.

          -  Have provided informed consent or have a legally authorized (LAR) provide consent for
             study procedures

          -  Have had volumetric brain MRI obtained in site's companion protocol within one year of
             enrollment

          -  Can tolerate PET scan procedures

        Exclusion Criteria:

          -  Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or
             endocrine disturbances that pose potential safety risk

          -  Have history of risk factors for Torsades de Pointes (TdP) or taking medication known
             to cause QT prolongation

          -  Have history of drug or alcohol dependence within the last year

          -  Are females of childbearing potential who are not surgically sterile, not refraining
             from sexual activity, or not using reliable contraception

          -  Have history of relevant severe drug allergy or hypersensitivity

          -  Have received an investigational medication under FDA IND protocol within 30 days of
             planned imaging session

          -  Have received a radiopharmaceutical for imaging/therapy within 24 hours of imaging
             session

          -  Possess PET scan evidence of amyloid deposition

          -  Determined by the investigator to be unsuitable for this type of study
A Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Patients With Solid Tumors (0683-048)
Condition: Tumors
Intervention: Vorinostat; Vorinostat
Intervention description: 600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest.; 400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.
Intervention MeSH terms: Vorinostat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This is a clinical study to evaluate the safety and pharmacokinetics of an overseas
      determined maximum tolerated dose (MTD) of MK-0683 (vorinostat) in a Japanese patient
      population with solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histologically or cytologically diagnosed solid tumor in whom no
             standard therapy is available or the malignancy is refractory to standard therapy

        Exclusion Criteria:

          -  Patients with history of immunotherapy, radiotherapy, surgery, or chemotherapy during
             the previous 4 weeks

          -  Any uncontrolled concomitant illness

          -  Pregnant or breast-feeding

          -  Serious drug or food allergy
Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma
Condition: Advanced Solid Malignancies; Malignant Lymphoma
MeSH terms: Lymphoma; Neoplasms
Intervention: AZD1208
Intervention description: Dose of AZD1208 will be escalated from 120mg to a maximum tolerated dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Advanced solid malignancies; Malignant lymphoma

Summary:

      The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a
      maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when
      given daily to patients with advanced solid malignancies including malignant lymphoma
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have signed this Written Informed Consent Form after a full explanation
             about the participation in this study

          -  Patients aged 18 years or older Patients diagnosed with a solid malignant tumour or
             malignant lymphoma that is refractory to standard therapies or for which no standard
             therapies exist

          -  Patients with good physical conditions (you can walk and can look after yourself)
             within the last 2 weeks.

          -  Patients who have at least one lesion that can be accurately assessed

        Exclusion Criteria:

          -  Patients who have recently received or are receiving prohibited medications or
             treatments

          -  Patients who have any unresolved side effects of previous treatments

          -  Patients who have spinal cord compression or brain metastases

          -  Patients who have severe systemic diseases (e.g., uncontrolled hypertension, hepatitis
             B, hepatitis C and human immunodeficiency virus [HIV] infection)

          -  Patients with significant abnormal ECG findings
A Study of Lanabecestat (LY3314814) in Healthy Participants When Taken With Rosuvastatin
Condition: Healthy
Intervention: Lanabecestat; Rosuvastatin
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the effect of lanabecestat on rosuvastatin. The
      amount of rosuvastatin in the blood will be compared, when taken alone, and then when taken
      with lanabecestat. The amount of lanabecestat that gets into the bloodstream will be
      measured. Information about any side effects that may occur will also be collected.

      Participants will be on study for 21 days with a follow-up at least 7 days afterwards.

      Screening will be undertaken within 45 days prior to enrollment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women not of childbearing potential may participate and include those who are:

               -  Infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or
                  tubal ligation), congenital anomaly such as mullerian agenesis; or

               -  Postmenopausal - defined as women over 50 years of age with an intact uterus who
                  have not taken hormones or oral contraceptives within 1 year, who have had either
                  Spontaneous cessation of menses for at least 12 consecutive months, or 6 to 12
                  months of spontaneous amenorrhea with follicle-stimulating hormone level greater
                  than (>)40 milli-international units per millilitre (mIU/mL) consistent with
                  menopause

          -  Caucasian and may be of Hispanic ethnicity

          -  Body mass index (BMI) of 19 to 32 kilogram per meter square (kg/m²), inclusive, at the
             time of screening

        Exclusion Criteria:

        - Have a clinically significant abnormal blood pressure or heart rate (supine) as
        determined by the investigator
Volasertib in Japanese Patients With Acute Myeloid Leukemia (AML)
Condition: Leukemia, Myeloid, Acute
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Volasertib
Intervention description: Patient to receive volasertib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      To investigate safety, tolerability, maximum tolerated dose of volasertib in Japanese
      patients with AML
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients with diagnosis of AML (except for acute promyelocytic leukemia, APL)
             according to the World Health Organization definition and with one of the following
             features at screening

               -  Relapsed or refractory AML

               -  Untreated AML patients not considered to be suitable for standard induction
                  therapy according to investigator's judgement

          2. Male or female patients of age >/= 18 years at the time of informed consent

          3. Eastern Cooperative Oncology Group performance status score 0 - 2 at screening

          4. Signed written informed consent consistent with Japanese Good Clinical Practice.

        Exclusion criteria:

          1. Patients with APL

          2. Patients in the third or later relapse

          3. Prior stem cell transplantation

          4. Treatment with systemic therapy for the primary disease (including an investigational
             drug) within 14 days before the first dose of volasertib with the exception of
             hydroxyurea, or lack of recovery from any acute toxicities or clinically significant
             adverse events pertinent to the prior systemic therapy

          5. Treatment with gemtuzumab ozogamicin within 6 weeks before the first dose of
             volasertib

          6. Concomitant medication/treatment with anti-leukemic chemotherapy (systemic or
             intrathecal), radiotherapy, immunotherapy, or any investigational agent while
             receiving study treatment

          7. Other malignancy requiring treatment at the time of screening

          8. Clinical central nervous system (CNS) symptoms deemed by the investigator to be
             related to leukemic CNS involvement or requiring treatment
Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea
Condition: Chronic Functional Diarrhea of Unknown Origin
MeSH terms: Diarrhea
Intervention: Diosmectite (Smecta®)
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Intervention model description: The study is interventional Phase 1 without individual benefit.
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to assess the concentration of elemental impurities in
      blood and urine after chronic administration of Smecta® in subjects with chronic functional
      diarrhoea. For exploratory purposes, the potential effects of diosmectite on bowel microbiote
      composition will be investigated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects, between 18 and 60 years old inclusive, BMI between 19 and 32
             kg/m2 inclusive (minimum body weight of 50 kg at screening).

          -  Functional chronic diarrhoea defined as loose or watery stools occurring in at least
             75% of stools for the last 3 months (with symptom onset at least 6 months before
             diagnosis).

        Exclusion Criteria:

          -  No history of suspected organic or drug induced cause to chronic diarrhoea.
A Study of an Investigational V212/Heat-Treated Varicella-Zoster Virus (VZV) Vaccine in Immunocompromised Adults (V212-002)
Condition: Herpes Zoster; Herpes Zoster-related Complications
MeSH terms: Herpes Simplex; Herpes Zoster; Chickenpox
Intervention: V212; Placebo
Intervention description: 0.65 ml V212 in 4 dose regimen. Treatment period of 125 days; 0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 341.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prevention of herpes zoster and HZ-related complications

Summary:

      This study will evaluate the safety and immunogenicity of a heat-treated VZV vaccine in
      autologous or allogeneic hematopoietic cell transplant (HCT) recipients, human
      immunodeficiency virus (HIV)-infected participants with a baseline cluster of differentiation
      4 (CD4) cell count ≤200 cells/mm^3, participants with solid tumor malignancy (STM; breast,
      colorectal, lung, or ovarian malignancies) receiving chemotherapy, and participants with
      hematologic malignancy (HM; leukemia or leukemia-like disease, lymphoma or lymphoma-like
      disease, or multiple myeloma). The primary hypothesis is that the heat-treated VZV vaccine
      will elicit significant VZV-specific immune responses measured by either glycoprotein-based
      enzyme-linked immunosorbent assay (gpELISA) or VZV gamma interferon enzyme-linked immunospot
      (IFN-ELISPOT) at 28 days post dose vaccination 4 in, HIV-infected participants, participants
      with STM, and participants with HM. The primary immunogenicity objective and endpoints were
      considered by the protocol as exploratory for the autologous and allogeneic HCT groups.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women > or = to 18 years of age who are scheduled to receive an autologous or
             allogeneic hematopoietic cell transplant within 60 days of enrollment

          -  HIV-infected participants with a baseline CD4 cell count < or = to 200 cells/mm^3

          -  Participants with hematologic malignancies; or participants who are receiving
             chemotherapy for breast, colorectal, lung, or ovarian malignancies

        Exclusion Criteria:

          -  History of allergy to any vaccine component

          -  Prior history of HZ

          -  Prior history of receipt of any varicella or zoster vaccine
Dose Finding Study of BI 6727 (Volasertib) in Patients With Various Solid Cancers
Condition: Neoplasms
Intervention: BI 6727
Intervention description: Dose level 1
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI
      6727 in Asian cancer patients, and to provide safety data in terms of drug-related adverse
      events.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients with histologically or cytologically confirmed diagnosis of advanced solid
             cancer

          2. Age 18 years or older

          3. Written informed consent

          4. Eastern Cooperative Oncology Group (ECOG) performance score 2 or less

        Exclusion criteria:

          1. Serious illness or concomitant non-oncological disease.

          2. Pregnancy or breast feeding

          3. Active infectious disease

          4. Absolute neutrophil count less than 1,500/cubic millimeter

          5. Platelet count less than 100,000/cubic millimeter

          6. Bilirubin greater than 1.5 mg/dL (> 26 µmol/L, SI unit equivalent)

          7. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater
             than 2.5 times the upper limit of normal

          8. Serum creatinine greater than 1.5x ULN.
Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg (T80/A5/H12.5 mg) Fixed-dose Combination (FDC) Tablet and T80/H12.5 mg Tab and A5 mg (Encap A2.5 mg Tab x2) Concomitant Use
Condition: Healthy
Intervention: Amlodipine 5mg capsule; T80/H12.5 mg FDC tablet; T80/A5/H12.5 mg FDC tablet
Intervention description: Amlodipine 5mg capsule; Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg FDC tablet; Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg FDC tablet
Intervention MeSH terms: Amlodipine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: Male
Minimum age: 20 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the steady state pharmacokinetics of different formulation of Telmisartan,
      Amlodipine, and Hydrochlorothiazide (HCTZ).
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male subjects age >=20 and <=35 years; body weight: >=50 kg and <=80 kg; body
             mass index: >=18.0 and <=25.0 kg/m2

          -  Without any clinically significant findings and complications on the basis of a
             complete medical history, including the physical examination, vital signs (blood
             pressure (BP), pulse rate (PR), body temperature)

          -  Signed and dated written informed consent prior to admission to the trial in
             accordance with the Good Clinical Practice (GCP) and the local legislation

        Exclusion criteria:

        - Any finding of the medical examination (including BP, PR and ECGs) deviating from normal
        and of clinical relevance
Buspirone as a Candidate Medication for Methamphetamine Abuse
Condition: Methamphetamine Dependence; Methamphetamine Abuse
Intervention: Methamphetamine; Placebo
Intervention description: The pharmacodynamic effects of methamphetamine will be determined during placebo and buspirone maintenance.; The pharmacodynamic effects of placebo methamphetamine will be determined during placebo and buspirone maintenance.
Intervention MeSH terms: Methamphetamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Methamphetamine use disorders are an unrelenting public health concern. Intensive research
      efforts have yielded behavioral interventions that reduce methamphetamine use, however, these
      interventions are not universally effective and treatment effects diminish over time.
      Development of a pharmacotherapy that enhances the efficacy of these interventions is a
      priority for the National Institute on Drug Abuse. This study proposes to determine the
      impact of buspirone maintenance on self-administration of methamphetamine. These preliminary
      data will be used to support further research developing buspirone as a pharmacotherapy for
      methamphetamine use disorders. The investigators hypothesize that buspirone will attenuate
      the reinforcing effects of methamphetamine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Lifetime methamphetamine use

        Exclusion Criteria:

          -  Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians
             deem clinically significant

          -  Current or past histories of substance abuse or dependence 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 or buspirone
Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers
Condition: Healthy Adult Volunteers
Intervention: Drug: OP0201; Drug: Placebo
Intervention description: Drug OP0201; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety and tolerability of two dose levels of
      OP0201 and placebo, when administered intranasally in healthy adults subjects.
    

Eligibility criteria:

        Inclusion Criteria includes but is not limited to:

          1. Body mass index of 18 to 30 kg/m2 (inclusive) and a minimum body weight of 50 kg at
             Screening.

          2. Able and willing to follow study instructions (including compliance with daily study
             treatment administration) and likely to complete all required study visits as assessed
             by the Investigator's judgement.

          3. Female subjects must agree to use an acceptable method of contraception (for pregnancy
             considerations and contraceptive requirements).

          4. Female subjects who are of childbearing potential must have a negative urine pregnancy
             test result at Screening and Day -1 prior to randomization.

          5. Male subjects must agree to use contraception

          6. Subjects must agree to refrain from immersing their head fully under water (eg,
             swimming, diving) from the time of signed informed consent until after the study exit
             visit.

          7. Physiologic tympanogram classified as Type A (normal) by the Investigator or designee.

        Exclusion Criteria includes but is not limited to:

          1. History or presence of significant medical condition or a clinically significant
             abnormal finding, as determined by the Investigator.

          2. Presence of a clinically significant abnormal olfactory test finding at Screening
             defined as a total UPSIT score <35 (for females) and <34 (for males).

          3. Clinically significant ear disorder/disease currently or within 6 weeks prior to
             Screening.

          4. History of tympanostomy tubes in one or both ears within 1 year prior to Screening.

          5. Upper respiratory tract infection or pharyngitis currently or within 6 weeks prior to
             Screening.

          6. Allergy or sinus conditions (eg, sinusitis, non-specific nasal inflammation) currently
             or within 6 weeks prior to Screening.

          7. Clinically relevant blockage of one or both nasal passages, in the Investigator's
             opinion.

          8. Gastroesophageal reflux disease currently or within 6 weeks prior to Screening.