anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: N-(3-((4aS,7aS)-2-amino-4a,5,7,7a-tetrahydro-4H-furo[3,4-d][1,3]thiazin-7a-yl)-4-fluorophenyl)-5-fluoropicolinamide
Trial phase: Phase 1 | Phase 2
SMILES: NC1=NC2(c3cc(NC(=O)c4ccc(F)cn4)ccc3F)COCC2CS1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: LY2886721: 15 mg, capsules, administered orally, once daily for 26 weeks.
Eligibility criteria:
Inclusion Criteria:

Meets criteria for MCI due to AD or Mild AD

All participants will be required to undergo assessment via the Mini Mental State Examination (MMSE) scale at screening

Participants with MMSE scores of 20 to 26, inclusive, may be enrolled provided they meet the criteria for mild AD, as follows:

Participant meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD
Clinical Dementia Rating Scale (CDR) score of 0.5 or 1
Positive scan for the presence of amyloid beta

Participants with MMSE of 27 to 30, inclusive, may be enrolled as participants with MCI due to AD provided they meet the following criteria:

Gradual and progressive change in memory function as reported by the participant or a caregiver during a period of more than 6 months
Free and Cued Selective Reminding Test with Immediate Recall (FCSRT-IR): free recall ≤22 and total recall ≤46
Absence of dementia
Preservation of functional independence
Exclusion of other potential (vascular, traumatic, or medical) causes of cognitive decline, where possible
Positive scan for the presence of amyloid beta
Women must be postmenopausal
Men are required to use an approved barrier method of contraception if their partners are pregnant, or of childbearing potential and not using approved contraceptive methods

Exclusion Criteria:

Participant in another drug or device study
Have a history of frontotemporal dementia, Lewy body disease, vascular dementia, Huntington's disease, Parkinson's disease, progressive supranuclear palsy (PSNP), or other movement disorder
Participants are not on a stable standard of care (acetylcholinesterase inhibitors, memantine) initiated less than 2 months prior to entry or have less than 4 weeks of stable therapy. Note: Stable standard of care is allowed.
Have had a serious infectious disease affecting the brain in the past 5 years
Have had a serious or repeat head injury
Have significant retinal impairment or disease
Have had a stroke or other circulation problems that are affecting current health
Have had a seizure
Have major depressive disorder and are not on a stable dose of medication. Participants who no longer meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV) criteria for major depression may be included
History of schizophrenia, bipolar disorder, or severe mental illness
History of alcohol or drug abuse
Have asthma, chronic obstructive pulmonary disease (COPD), or other breathing disease that is not controlled with medicine
Have human immunodeficiency virus (HIV) or syphilis
Are taking blood thinners
Intervention: N-(3-((4aS,7aS)-2-amino-4a,5,7,7a-tetrahydro-4H-furo[3,4-d][1,3]thiazin-7a-yl)-4-fluorophenyl)-5-fluoropicolinamide
Trial phase: Phase 1 | Phase 2
SMILES: NC1=NC2(c3cc(NC(=O)c4ccc(F)cn4)ccc3F)COCC2CS1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
Eligibility criteria:
Inclusion Criteria:

Meets criteria for MCI due to AD or Mild AD

All participants will be required to undergo assessment via the Mini Mental State Examination (MMSE) scale at screening

Participants with MMSE scores of 20 to 26, inclusive, may be enrolled provided they meet the criteria for mild AD, as follows:

Participant meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD
Clinical Dementia Rating Scale (CDR) score of 0.5 or 1
Positive scan for the presence of amyloid beta

Participants with MMSE of 27 to 30, inclusive, may be enrolled as participants with MCI due to AD provided they meet the following criteria:

Gradual and progressive change in memory function as reported by the participant or a caregiver during a period of more than 6 months
Free and Cued Selective Reminding Test with Immediate Recall (FCSRT-IR): free recall ≤22 and total recall ≤46
Absence of dementia
Preservation of functional independence
Exclusion of other potential (vascular, traumatic, or medical) causes of cognitive decline, where possible
Positive scan for the presence of amyloid beta
Women must be postmenopausal
Men are required to use an approved barrier method of contraception if their partners are pregnant, or of childbearing potential and not using approved contraceptive methods

Exclusion Criteria:

Participant in another drug or device study
Have a history of frontotemporal dementia, Lewy body disease, vascular dementia, Huntington's disease, Parkinson's disease, progressive supranuclear palsy (PSNP), or other movement disorder
Participants are not on a stable standard of care (acetylcholinesterase inhibitors, memantine) initiated less than 2 months prior to entry or have less than 4 weeks of stable therapy. Note: Stable standard of care is allowed.
Have had a serious infectious disease affecting the brain in the past 5 years
Have had a serious or repeat head injury
Have significant retinal impairment or disease
Have had a stroke or other circulation problems that are affecting current health
Have had a seizure
Have major depressive disorder and are not on a stable dose of medication. Participants who no longer meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV) criteria for major depression may be included
History of schizophrenia, bipolar disorder, or severe mental illness
History of alcohol or drug abuse
Have asthma, chronic obstructive pulmonary disease (COPD), or other breathing disease that is not controlled with medicine
Have human immunodeficiency virus (HIV) or syphilis
Are taking blood thinners
Intervention: Sorafenib
Trial phase: Phase 1
ATC code: L01EX02 | L01XE05
SMILES: CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)cc2)ccn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: sorafenib
Eligibility criteria:
Inclusion Criteria:

Histologically confirmed T-cell lymphoma including PTCL, AITL, CTCL, ALCL (Alk+, and Alk-), and other transformed T-cell lymphomas
Age > 18 years old
Measureable disease, as defined by the Cheson criteria
ECOG Performance Status of 0 or 1
Life expectancy > 12 weeks
Adequate bone marrow, liver and renal function
Patients with hemoglobin < 8.5g/dL, or ANC 500-1000/mm3, or platelets 50,000-75,000/mm3 (Grade 3), whose cytopenias are due to bone marrow involvement by T-cell lymphoma will also be eligible

Exclusion Criteria:

Prior treatment with sorafenib, or other agents with similar activity, i.e. bevacizumab, imatinib, sunitinib.
Prior treatment with allogeneic stem cell transplant
Cardiac disease: Congestive heart failure > class II NYHA.
Intervention: Ranolazine
Trial phase: Phase 2
ATC code: C01EB18
SMILES: COc1ccccc1OCC(O)CN1CCN(CC(=O)Nc2c(C)cccc2C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Participants received ranolazine, 500 mg, orally, b.i.d., up to 14 days.
Eligibility criteria:
Inclusion Criteria:

History of stable coronary artery disease

Exclusion Criteria:

Inability or unwillingness to participate in multiple exercise treadmill tests and/or any other requirements of this study as assessed by the Investigator.

History of chronic atrial fibrillation.

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Flucytosine
Trial phase: Phase 2
ATC code: D01AE21 | J02AX01
SMILES: Nc1[nH]c(=O)ncc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Combination therapy with oral fluconazole and flucytosine

Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily
Eligibility criteria:
Inclusion Criteria:

Able and willing to give informed consent
Age > 18 years
HIV infection as confirmed by HIV-antibody test as per Kenyan guidelines
CD4+ T-cell count ≤100 cells/µl
Serum CrAg titer≥1:2
Able to travel to district hubs (Sindo District Hospital, Lumumba Health Centre) for regular study visits

Exclusion Criteria:

clinical meningitis:
clinical sepsis:
hemiparesis, aphasia, visual field deficit or other finding on neurological examination localizable to the central nervous system
a history of culture proven or suspected (cryptococcal antigen present) cryptococcal meningitis
a history of stroke or other infection of the central nervous system
a seizure within the last 2 months
currently taking or ever taken antiretroviral therapy
currently taking anti-tuberculous therapy
currently or recently (<2 months) prescribed fluconazole, itraconazole, clotrimazole troches, amphotericin or other oral anti-fungal medications
pregnant or breast-feeding
alanine aminotransferase concentration more than 3 times the upper limit of normal
neutrophil count <1000x103 cells/mL
hemoglobin <8g/dL
platelet count <100,000x 103 platelets/mL
creatinine clearance ≤50 ml/min
individuals with active heavy alcohol use or active recreational drug use
Intervention: Fluconazole
Trial phase: Phase 2
ATC code: D01AC15 | J01RA07 | J02AC01
SMILES: OC(Cn1cncn1)(Cn1cncn1)c1ccc(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Fluconazole monotherapy

Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily
Eligibility criteria:
Inclusion Criteria:

Able and willing to give informed consent
Age > 18 years
HIV infection as confirmed by HIV-antibody test as per Kenyan guidelines
CD4+ T-cell count ≤100 cells/µl
Serum CrAg titer≥1:2
Able to travel to district hubs (Sindo District Hospital, Lumumba Health Centre) for regular study visits

Exclusion Criteria:

clinical meningitis:
clinical sepsis:
hemiparesis, aphasia, visual field deficit or other finding on neurological examination localizable to the central nervous system
a history of culture proven or suspected (cryptococcal antigen present) cryptococcal meningitis
a history of stroke or other infection of the central nervous system
a seizure within the last 2 months
currently taking or ever taken antiretroviral therapy
currently taking anti-tuberculous therapy
currently or recently (<2 months) prescribed fluconazole, itraconazole, clotrimazole troches, amphotericin or other oral anti-fungal medications
pregnant or breast-feeding
alanine aminotransferase concentration more than 3 times the upper limit of normal
neutrophil count <1000x103 cells/mL
hemoglobin <8g/dL
platelet count <100,000x 103 platelets/mL
creatinine clearance ≤50 ml/min
individuals with active heavy alcohol use or active recreational drug use
Intervention: Rilpivirine
Trial phase: Phase 1
ATC code: J05AG05 | J05AR08 | J05AR19 | J05AR21
SMILES: Cc1cc(/C=C/C#N)cc(C)c1Nc1ccnc(Nc2ccc(C#N)cc2)n1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily

Rilpivirine: Rilpivirine 26mg
Eligibility criteria:
Inclusion Criteria:

HIV-1 infected males subjects
signed informed consent
willing to switch therapy as per study protocol
no previous exposure to rilpivirine
plasma HIV RNA < 50 copies/mL at screening and on at least one other occasion over the last 3 months
currently receiving a stable antiretroviral regimen comprising of TDF/FTC with nevirapine with nevirapine dosed either 200 mg twice daily or 400 mg once daily with no antiretroviral drug switches for at least 3 months
no clinically-significant resistance documented on any prior HIV-1 genotypic resistance testing
subjects in good health upon medical history, physical exam, and laboratory testing
BMI above or equal to 18 and below 32
Male subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom and diaphragm) during heterosexual intercourse, from screening through completion of the study.
Have local screening laboratory results (haematology and chemistry that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical significance
No contraindications to having a lumbar puncture examination found on MRI of the brain

Exclusion Criteria:

current alcohol abuse or drug dependence
positive urine drug of abuse screening
active opportunistic infection or significant co-morbidities
current disallowed concomitant medication (as listed in section 4.1.3)
contraindication to MR examination or lumbar puncture examination
recent head injury (in last 30 days) or chronic ongoing neurological diseases
Intervention: FLORBETAPIR
Trial phase: Early Phase 1
ATC code: V09AX05
SMILES: CNc1ccc(C=Cc2ccc(OCCOCCOCCF)nc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
Eligibility criteria:
Inclusion Criteria (AD group):

Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
Mild/moderate dementia as evidenced by a mini mental state exam (MMSE) score ranging from 10 to 24, boundaries included, at screening
History of cognitive decline had been gradual in onset and progressive over a period of at least 6 months

Inclusion Criteria (healthy volunteer group):

No evidence of significant cognitive impairment by history and psychometric testing
MMSE of 29 or higher

Exclusion Criteria (both groups):

Neurodegenerative disorders other than AD
Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
Clinically significant psychiatric disease
History of epilepsy or convulsions
Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
Current clinically significant cardiovascular disease
Received investigational medication within the last 30 days
Intervention: FLORBETAPIR
Trial phase: Early Phase 1
ATC code: V09AX05
SMILES: CNc1ccc(C=Cc2ccc(OCCOCCOCCF)nc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: Cognitively normal with MMSE of 29 or higher; age 50 years or older
Eligibility criteria:
Inclusion Criteria (AD group):

Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
Mild/moderate dementia as evidenced by a mini mental state exam (MMSE) score ranging from 10 to 24, boundaries included, at screening
History of cognitive decline had been gradual in onset and progressive over a period of at least 6 months

Inclusion Criteria (healthy volunteer group):

No evidence of significant cognitive impairment by history and psychometric testing
MMSE of 29 or higher

Exclusion Criteria (both groups):

Neurodegenerative disorders other than AD
Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
Clinically significant psychiatric disease
History of epilepsy or convulsions
Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
Current clinically significant cardiovascular disease
Received investigational medication within the last 30 days
Intervention: FLORBETAPIR
Trial phase: Phase 1
ATC code: V09AX05
SMILES: CNc1ccc(C=Cc2ccc(OCCOCCOCCF)nc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
Eligibility criteria:
Inclusion Criteria (AD group):

Greater than 50 years of age
Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening
History of cognitive decline gradual in onset and progressive over a period of at least 6 months

Inclusion Criteria (healthy volunteer group):

35 to 55 years of age, inclusive
MMSE of 29 or greater

Exclusion Criteria (both groups):

Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy
Diagnosis of other dementing / neurodegenerative disease
Diagnosis of mixed dementia
Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
Clinically significant psychiatric disease
History of epilepsy or convulsions
Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
Current clinically significant cardiovascular disease
Received investigational medication within the last 30 days
Intervention: FLORBETAPIR
Trial phase: Phase 1
ATC code: V09AX05
SMILES: CNc1ccc(C=Cc2ccc(OCCOCCOCCF)nc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
Eligibility criteria:
Inclusion Criteria (AD group):

Greater than 50 years of age
Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening
History of cognitive decline gradual in onset and progressive over a period of at least 6 months

Inclusion Criteria (healthy volunteer group):

35 to 55 years of age, inclusive
MMSE of 29 or greater

Exclusion Criteria (both groups):

Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy
Diagnosis of other dementing / neurodegenerative disease
Diagnosis of mixed dementia
Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
Clinically significant psychiatric disease
History of epilepsy or convulsions
Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
Current clinically significant cardiovascular disease
Received investigational medication within the last 30 days
Intervention: FLORBETAPIR
Trial phase: Phase 1
ATC code: V09AX05
SMILES: CNc1ccc(C=Cc2ccc(OCCOCCOCCF)nc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 4
Group description: Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
Eligibility criteria:
Inclusion Criteria (AD group):

Greater than 50 years of age
Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening
History of cognitive decline gradual in onset and progressive over a period of at least 6 months

Inclusion Criteria (healthy volunteer group):

35 to 55 years of age, inclusive
MMSE of 29 or greater

Exclusion Criteria (both groups):

Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy
Diagnosis of other dementing / neurodegenerative disease
Diagnosis of mixed dementia
Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
Clinically significant psychiatric disease
History of epilepsy or convulsions
Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
Current clinically significant cardiovascular disease
Received investigational medication within the last 30 days