anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Olanzapine
Trial phase: Phase 3
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 110
Group description: 5-20 mg by mouth once daily for 26 weeks
Eligibility criteria:
Inclusion Criteria:

Continue to meet all demographic and procedural

inclusion criteria of the A7501013 trial to enter into

this extension trial.

Have demonstrated an acceptable degree of compliance

and completed the A7501013 trial, and would benefit

from continued treatment according to the investigator.

Exclusion Criteria:

Have an uncontrolled, unstable clinically significant

medical condition.

Have been judged to be medically noncompliant in the

management of their disease.
Intervention: Donepezil
Trial phase: Phase 3
ATC code: N06DA02 | N06DA52 | N06DA53
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 148
Group description: Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects must meet DSM-IV-TR criteria for the clinical diagnosis of Vascular Dementia or the clinical diagnosis of dementia due to multiple etiologies.
Subjects must have a reliable caregiver or family member who agrees to accompany the subject to all scheduled visits, provide information about the subject as required.

Exclusion Criteria:

Subjects with any current primary psychiatric diagnosis other than dementia of the Alzheimer's type or Vascular Dementia.
Intervention: Ziprasidone
Trial phase: Phase 3
ATC code: N05AE04
SMILES: O=C1Cc2cc(CCN3CCN(c4nsc5ccccc45)CC3)c(Cl)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
Eligibility criteria:
Inclusion Criteria:

Patients who successfully completed study A1281031 (CGI score of 1 or 2 at final visit) or ZIP-NY-98035 and with QTc <= 500 msec.

Exclusion Criteria:

All other patients who do not fit the inclusion criteria as stated above.
Intervention: Febuxostat
Trial phase: Phase 3
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 267
Group description: Febuxostat 80 mg, orally, once daily for up to 28 weeks.
Eligibility criteria:
Inclusion Criteria:

Hyperuricemia (serum urate ≥8.0 mg/dL and gout by American Rheumatism Association Criteria
Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine clearance of > 20 milliliters per minute (mL/min) by Cockroft and Gault formula.

Exclusion Criteria:

History of xanthinuria
Intolerance to allopurinol
Presence of renal calculi,
Alcohol intake of ≥ 14 drinks/week
Clinically significant medical condition
Intervention: Febuxostat
Trial phase: Phase 3
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 269
Group description: Febuxostat 120 mg, orally, once daily for up to 28 weeks.
Eligibility criteria:
Inclusion Criteria:

Hyperuricemia (serum urate ≥8.0 mg/dL and gout by American Rheumatism Association Criteria
Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine clearance of > 20 milliliters per minute (mL/min) by Cockroft and Gault formula.

Exclusion Criteria:

History of xanthinuria
Intolerance to allopurinol
Presence of renal calculi,
Alcohol intake of ≥ 14 drinks/week
Clinically significant medical condition
Intervention: Febuxostat
Trial phase: Phase 3
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 134
Group description: Febuxostat 240 mg, orally, once daily for up to 28 weeks.
Eligibility criteria:
Inclusion Criteria:

Hyperuricemia (serum urate ≥8.0 mg/dL and gout by American Rheumatism Association Criteria
Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine clearance of > 20 milliliters per minute (mL/min) by Cockroft and Gault formula.

Exclusion Criteria:

History of xanthinuria
Intolerance to allopurinol
Presence of renal calculi,
Alcohol intake of ≥ 14 drinks/week
Clinically significant medical condition
Intervention: Allopurinol
Trial phase: Phase 3
ATC code: M04AA01 | M04AA51
SMILES: Oc1ncnc2[nH]ncc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 268
Group description: Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
Eligibility criteria:
Inclusion Criteria:

Hyperuricemia (serum urate ≥8.0 mg/dL and gout by American Rheumatism Association Criteria
Renal function defined as a serum creatinine level of < 2.0 mg/dL and creatinine clearance of > 20 milliliters per minute (mL/min) by Cockroft and Gault formula.

Exclusion Criteria:

History of xanthinuria
Intolerance to allopurinol
Presence of renal calculi,
Alcohol intake of ≥ 14 drinks/week
Clinically significant medical condition
Intervention: Febuxostat
Trial phase: Phase 2
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Febuxostat 40 mg, orally, once daily.
Eligibility criteria:
Inclusion Criteria:

Hyperuricemia (serum uric acid ≥8.0 mg/dL).
Must meet American College of Rheumatology criteria for gout.
Must have adequate renal function (serum creatinine <1.5 mg/dL).
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Exclusion Criteria:

History of xanthinuria
Alcohol consumption >14/week
Has a history of significant concomitant illness.
Has active liver disease.
Has a body mass index greater than 50 kilogram per meter² (kg/m²)
Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator.
Intervention: Febuxostat
Trial phase: Phase 2
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Febuxostat 80 mg, orally, once daily.
Eligibility criteria:
Inclusion Criteria:

Hyperuricemia (serum uric acid ≥8.0 mg/dL).
Must meet American College of Rheumatology criteria for gout.
Must have adequate renal function (serum creatinine <1.5 mg/dL).
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Exclusion Criteria:

History of xanthinuria
Alcohol consumption >14/week
Has a history of significant concomitant illness.
Has active liver disease.
Has a body mass index greater than 50 kilogram per meter² (kg/m²)
Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator.
Intervention: Febuxostat
Trial phase: Phase 2
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Febuxostat 120 mg, orally, once daily.
Eligibility criteria:
Inclusion Criteria:

Hyperuricemia (serum uric acid ≥8.0 mg/dL).
Must meet American College of Rheumatology criteria for gout.
Must have adequate renal function (serum creatinine <1.5 mg/dL).
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Exclusion Criteria:

History of xanthinuria
Alcohol consumption >14/week
Has a history of significant concomitant illness.
Has active liver disease.
Has a body mass index greater than 50 kilogram per meter² (kg/m²)
Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator.
Intervention: Febuxostat
Trial phase: Phase 3
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 801
Group description: Febuxostat 80 mg, taken orally, once daily.
Eligibility criteria:
Inclusion Criteria:

Is receiving thiazide diuretic therapy (only to subjects randomized to or receiving febuxostat).
Has a serum urate level less than 8.0 mg/dL and is not taking uric acid-lowering therapy (other than allopurinol or febuxostat).
Has participated in a clinical study in which febuxostat was administered.
Is completing Phase 3 Studies C02-009 or C02-010.
Must not have experienced any serious study drug-related adverse events in the previous study.
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study

Exclusion Criteria:

Has had any other significant medical condition as defined by the investigator that would interfere with the treatment, safety, or compliance with the protocol.
Is intolerant of allopurinol.
Intervention: Febuxostat
Trial phase: Phase 3
ATC code: M04AA03
SMILES: Cc1nc(-c2ccc(OCC(C)C)c(C#N)c2)sc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 487
Group description: Febuxostat 120 mg, taken orally, once daily
Eligibility criteria:
Inclusion Criteria:

Is receiving thiazide diuretic therapy (only to subjects randomized to or receiving febuxostat).
Has a serum urate level less than 8.0 mg/dL and is not taking uric acid-lowering therapy (other than allopurinol or febuxostat).
Has participated in a clinical study in which febuxostat was administered.
Is completing Phase 3 Studies C02-009 or C02-010.
Must not have experienced any serious study drug-related adverse events in the previous study.
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study

Exclusion Criteria:

Has had any other significant medical condition as defined by the investigator that would interfere with the treatment, safety, or compliance with the protocol.
Is intolerant of allopurinol.
Intervention: Allopurinol
Trial phase: Phase 3
ATC code: M04AA01 | M04AA51
SMILES: Oc1ncnc2[nH]ncc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 178
Group description: Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
Eligibility criteria:
Inclusion Criteria:

Is receiving thiazide diuretic therapy (only to subjects randomized to or receiving febuxostat).
Has a serum urate level less than 8.0 mg/dL and is not taking uric acid-lowering therapy (other than allopurinol or febuxostat).
Has participated in a clinical study in which febuxostat was administered.
Is completing Phase 3 Studies C02-009 or C02-010.
Must not have experienced any serious study drug-related adverse events in the previous study.
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study

Exclusion Criteria:

Has had any other significant medical condition as defined by the investigator that would interfere with the treatment, safety, or compliance with the protocol.
Is intolerant of allopurinol.
Intervention: Brivaracetam
Trial phase: Phase 2
ATC code: N03AX23
SMILES: CCC[C@@H]1CC(=O)N([C@@H](CC)C(N)=O)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Brivaracetam 5 mg/day, 2.5 mg administered twice a day
Eligibility criteria:
Inclusion Criteria:

Male/female from 16 to 65 years
Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
History of partial onset seizures
Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1
Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.

Exclusion Criteria:

Seizure type IA non-motor as only seizure type
Seizures occurring only in clusters
Status epilepticus during the last 2 years before Visit 1
History of cerebrovascular accident (CVA)
Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
Intervention: Brivaracetam
Trial phase: Phase 2
ATC code: N03AX23
SMILES: CCC[C@@H]1CC(=O)N([C@@H](CC)C(N)=O)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: Brivaracetam 20 mg/day, 10 mg administered twice a day
Eligibility criteria:
Inclusion Criteria:

Male/female from 16 to 65 years
Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
History of partial onset seizures
Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1
Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.

Exclusion Criteria:

Seizure type IA non-motor as only seizure type
Seizures occurring only in clusters
Status epilepticus during the last 2 years before Visit 1
History of cerebrovascular accident (CVA)
Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
Intervention: Brivaracetam
Trial phase: Phase 2
ATC code: N03AX23
SMILES: CCC[C@@H]1CC(=O)N([C@@H](CC)C(N)=O)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: Brivaracetam 50 mg/day, 25 mg administered twice a day
Eligibility criteria:
Inclusion Criteria:

Male/female from 16 to 65 years
Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
History of partial onset seizures
Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1
Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.

Exclusion Criteria:

Seizure type IA non-motor as only seizure type
Seizures occurring only in clusters
Status epilepticus during the last 2 years before Visit 1
History of cerebrovascular accident (CVA)
Presence of any sign suggesting rapidly progressing brain disorder or brain tumor
Intervention: Risperidone
Trial phase: Phase 3
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Likely side effects include weight gain, muscle stiffness, sedation and tiredness.

Clarification: We did not note any serious side effects with either drug. We reported any adverse event that is found in greater than 5% of the participants in each group. Frequency of adverse events do not equal the fact that they are serious adverse events at any individual level.
Eligibility criteria:
Inclusion Criteria:

Children with Bipolar Disorder
Must be able to swallow tablets

Exclusion Criteria:

Children with general medical condition such as head injury, epilepsy, endocrine disorders
Those who are on mood altering medications such as steroids, and those diagnosed with mental retardation are excluded to avoid confounding and contributing factors to mood swings.
If we discover during the interview that the parent and/or child does not understand the consent/assent procedures, we will exclude them.

We expect only a small number of children to be excluded from the study due to exclusionary criteria. Selection of the subjects is not based on sex, race, or ethnic group.
Intervention: Lamotrigine
Trial phase: Phase 2
ATC code: N03AX09
SMILES: Nc1nnc(-c2cccc(Cl)c2Cl)c(N)n1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 48
Group description: upto 200 mg
Eligibility criteria:
Inclusion Criteria:

Ages 10-20
Must be able to swallow tablets
Must be diagnosed with bipolar disorder

Exclusion Criteria:

Children with general medical condition such as head injury, epilepsy, endocrine disorders
Those who are on mood altering medications such as steroids, and those diagnosed with mental retardation are excluded to avoid confounding and contributing factors to mood swings.
If we discover during the interview that the parent and/or child does not understand the consent/assent procedures, we will exclude them.
Girls who are pregnant or plan to become pregnant during the study period will also be excluded from the research. There have been no concerns raised in the literature about the need for birth control practices in males treated with lamotrigine. As such, there are no provisions to exclude males from the research who do not practice birth control.

We expect only a small number of children to be excluded from the study due to exclusionary criteria. Selection of the subjects is not based on sex, race, or ethnic group.

For the fMRI study:

Given the limited size of the magnet bore, individuals with a body weight over two-hundred and fifty pounds will be unable to be tested within the MRI scanner.
Women in the latter stages of pregnancy may be excluded due to large body size and potential discomfort while in the MRI apparatus. Please note that girls who are taking part in the drug portion of the study (this includes all female subjects except the 5 healthy adult, control women) will be given 3 pregnancy during the drug study. This is to rule out pregnancy since pregnant girls should not be taking the study medications for safety reasons.
Standard contraindications for fMRI studies include: cardiac pacemaker, aneurysm clip, cochlear implants, shrapnel, history of metal fragments in eyes, claustrophobia
Participants with an IQ of less than 70 (assessed by WRAT) are likely to be excluded due to difficulties comprehending tasks and procedures
Intervention: Tetrathiomolybdate
Trial phase: Phase 2
SMILES: S=[Mo](=S)([S-])[S-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.

Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.

Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50.
Eligibility criteria:
Eligibility Requirements

Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction
No prior treatment for the esophageal cancer allowed.
No prior thoracic or upper abdominal radiation.
Disease should be limited to the esophagus and regional lymph nodes. Regional lymph nodes are described in Section 4.0. However, celiac node enlargement will be acceptable for tumors of the distal esophagus, because they will be included in the radiation field.
Disease must be able to be encompassed in a single radiation field.
No medical contraindication to surgery
All treatment is to be administered at the University of Michigan Medical Center.
Karnofsky Performance Status (scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 100% where 100% represents perfect health and 0 represents death) > 70 %.
Age range: 18 - 75 years old.

Adequate baseline hematopoetic function:

Platelet count equal to or greater than 100,000/mm3 Absolute granulocyte count equal to or greater than 1500/mm3 Hematocrit equal to or greater than 29% (patients may be transfused to this level)

Adequate baseline organ function :

Creatinine clearance >/= 60 mls/min Bilirubin equal to or less than 1.5 x upper limits of normal AST (aspartate aminotransferase)/ALT (alanine aminotransferase) equal to or less than 2.5 x upper limits of normal

Patients with any complaint of hearing loss should be evaluated with an audiogram. The average pure tone average hearing loss from 500-2000Hz should not exceed 30 dB. If it does, the patient should be warned that further hearing loss may be very noticeable and permanent.
Prior malignancy is acceptable if the patient is considered to be cured. In most cases this will mean a 5-year disease-free period. Contact the Principal Investigator for any specific question regarding this requirement.
Patients with active infection, serious inter-current medical conditions are ineligible, according to the judgment of the investigators.
Pregnant or lactating females are not eligible. Women of childbearing Potential must be using contraception throughout the entire period of treatment.
Ability to give informed consent.
Intervention: Citalopram
Trial phase: Phase 4
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 26
Group description: Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem
Eligibility criteria:
Inclusion Criteria:

Physically healthy
Meets DSM-IV criteria for primary insomnia
For subjects interested in PET study only: right-handedness

Exclusion Criteria:

Currently taking antidepressants, antianxiety medications or medications for sleep disorders
Currently experiencing symptoms of psychiatric disorders such as major depressive disorder, bipolar disorder, generalized anxiety disorder
Significant or unstable acute or chronic medical conditions, such as seizure disorder, tumor, liver disease, active peptic ulcer disease, arthritis, irritable bowel disease
Meets DSM-IV criteria for sleep apnea or periodic limb movement disorder