anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Flutemetamol
Trial phase: Phase 3
ATC code: V09AX04
SMILES: CNc1ccc(-c2nc3ccc(O)cc3s2)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 232
Group description: Flutemetamol (18F) Injection: All subjects will receive an intravenous dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
Eligibility criteria:
Inclusion Criteria:

The subject is 60 years old or older.
The subject meets the Petersen criteria for amnestic MCI.
The subject has a score of less than or equal to 4 on the Modified Hachinski Ischemic Scale.
The subject has a MMSE score of 24-30.
The subject has a non-contrast MRI examination as part of the screening visit that excludes aMCI arising from structural causes.
The subject and/or the subject's legally acceptable representative, if applicable, in accordance with local regulations, has signed and dated an informed consent.

Exclusion Criteria:

The subject has any significant neurologic disease other than suspected aMCI; such as Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities.
The subject has one or more aneurysm clips, artificial heart valves, metal implants, embedded metal fragments or pacemakers that would pose a risk during an MRI.
The subject has major depression, bipolar disorder, as described in the DSM-IV within the past year.
The subject has history of schizophrenia (DSM-IV criteria).
The subject has had, within the prior 3 months, psychotic features, agitation or behavioral problems that could lead to protocol compliance issues.
Intervention: OXYTOCIN
Trial phase: Not Applicable
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks

intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks
Eligibility criteria:
Inclusion Criteria:

Meeting DSM-IV criteria for paranoid or undifferentiated schizophrenia for at least 1 year.
Scoring > or equal to 4 on the suspiciousness/persecution (paranoia) subscale of the Positive and Negative Symptoms Scale (PANSS), a full PANSS score > or equal to 60: stability of symptom severity and on the same medication(s) and dose(s) for at least 1 month; low to moderate depressive symptoms.

Exclusion Criteria:

Low literacy as indicated by an inability to read and understand the consent form.
Dependence on substances other than tobacco or caffeine.
Positive urine drug screen for illegal substances or drugs that have not been prescribed.
Debilitating medical conditions (including AIDS; HIV infection alone will not be grounds for exclusion).
Major surgery or trauma in the past year will be grounds for exclusion although subjects determined to be recovered and stable may be included at the discretion of the PI.
Pregnancy, breast-feeding.
Having given birth in the past 6 months or breast-feeding in the past 3 months.
Individuals judged unable to learn self-administration of intranasal treatments and/or not sufficiently reliable to do so will be excluded.
Abnormalities found during medical evaluation will be grounds for exclusion although subjects with laboratory measures barely outside the normal range may be included at the discretion of the Principal Investigator.
Intervention: PF-03654746
Trial phase: Phase 1
SMILES: CCNC(=O)[C@H]1C[C@@](F)(c2ccc(CN3CCCC3)c(F)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator's discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
Eligibility criteria:
Inclusion Criteria:

Probable Alzheimer's disease
Mini Mental State Examination score 18-26 inclusive
Aged 55-85

Exclusion Criteria:

Dementia other than Alzheimer's disease
Clinically significant cardiovascular disease in the past 6 months prior to screening
Creatinine clearance <30 mL/min
Intervention: Valsartan
Trial phase: Phase 4
ATC code: C09CA03 | C09DA03 | C09DB01 | C09DB08 | C09DX01 | C09DX02 | C09DX04 | C09DX05 | C10BX10
SMILES: CCCCC(=O)N(Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1)[C@H](C(=O)O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 94
Group description: In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
Eligibility criteria:
Inclusion Criteria:

Women or men within an age range from 30 to 69 years with uncomplicated hypertension.
Blood pressure measured in the sitting position after at least 5 minutes rest (average of three readings at the last run-in-visit) should range from 140 to 179 mm Hg systolic or from 90 to 109 mm Hg diastolic (grades 1 or 2 of hypertension). Patients must have uncomplicated hypertension with a maximum of two additional risk factors, as defined in the 2007 guidelines of the European Societies of Hypertension and Cardiology.
Systolic blood pressure in the upright position must be at least 110 mm Hg (mean of three readings obtained immediately after the patient has assumed a standing position).
Patients who have never been treated for hypertension or in whom previous antihypertensive drug treatment has been discontinued for at least four weeks before the last run-in visit can be randomised. If two weeks after discontinuation of previous antihypertensive treatment the blood pressure is higher than 160 mm Hg systolic or higher than 100 mm Hg diastolic and if the patient has complaints, the patient can be randomised immediately to active blood pressure lowering treatment with either the newer or older antihypertensive drugs.
The patient must provide informed written consent.

Exclusion Criteria:

Premenopausal women not applying anticonception.
A history of cardiovascular disease.
Secondary hypertension.
Electrocardiographic left ventricular hypertrophy.
More than two cardiovascular risk factors in addition to hypertension.
Diabetes mellitus.
Renal dysfunction.
Recent treatment with two or more antihypertensive drugs or a contra-indication to discontinue blood pressure lowering agents for 4 weeks.
Severe non-cardiovascular disease.
Known contra indications for the first-line study medications.
Intervention: Bisoprolol fumarate and hydrochlorothiazide
Trial phase: Phase 4
SMILES: CC(C)NCC(O)COc1ccc(COCCOC(C)C)cc1.NS(=O)(=O)c1cc2c(cc1Cl)NCNS2(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 89
Group description: In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
Eligibility criteria:
Inclusion Criteria:

Women or men within an age range from 30 to 69 years with uncomplicated hypertension.
Blood pressure measured in the sitting position after at least 5 minutes rest (average of three readings at the last run-in-visit) should range from 140 to 179 mm Hg systolic or from 90 to 109 mm Hg diastolic (grades 1 or 2 of hypertension). Patients must have uncomplicated hypertension with a maximum of two additional risk factors, as defined in the 2007 guidelines of the European Societies of Hypertension and Cardiology.
Systolic blood pressure in the upright position must be at least 110 mm Hg (mean of three readings obtained immediately after the patient has assumed a standing position).
Patients who have never been treated for hypertension or in whom previous antihypertensive drug treatment has been discontinued for at least four weeks before the last run-in visit can be randomised. If two weeks after discontinuation of previous antihypertensive treatment the blood pressure is higher than 160 mm Hg systolic or higher than 100 mm Hg diastolic and if the patient has complaints, the patient can be randomised immediately to active blood pressure lowering treatment with either the newer or older antihypertensive drugs.
The patient must provide informed written consent.

Exclusion Criteria:

Premenopausal women not applying anticonception.
A history of cardiovascular disease.
Secondary hypertension.
Electrocardiographic left ventricular hypertrophy.
More than two cardiovascular risk factors in addition to hypertension.
Diabetes mellitus.
Renal dysfunction.
Recent treatment with two or more antihypertensive drugs or a contra-indication to discontinue blood pressure lowering agents for 4 weeks.
Severe non-cardiovascular disease.
Known contra indications for the first-line study medications.
Intervention: Nateglinide
Trial phase: Phase 4
ATC code: A10BX03
SMILES: CC(C)[C@H]1CC[C@H](C(=O)N[C@H](Cc2ccccc2)C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: 120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
Eligibility criteria:
Inclusion criteria

Patients must give written informed consent before any assessment is performed.
Male, non-fertile female or female of childbearing potential using a medically approved birth control method based on local regulations.
Drug naïve type 2 diabetes patients, defined as who neither take consecutive anti-hyperglycemic drug treatment more than 3 months anytime, nor any anti-hyperglycemic drug treatment in 4 weeks prior to visit 1.
Age in the range of 18-75 years inclusive.
HbA1c in the range of > 6.5 to ≤9.0% at Visit 1.

Exclusion criteria

Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/mL).
With known hypersensitivity to Nateglinide, Acarbose or any of the excipients.

A history of,

type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation.
percutaneous coronary intervention within the past 3 months.
any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery, unstable angina, or stroke.
Evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy or gastroparesis.
Acute infections which may affect blood glucose control within 4 weeks prior to visit 1.
Congestive heart failure requiring pharmacologic treatment. mg/dL (123μmol/L)
Intervention: ACARBOSE
Trial phase: Phase 4
ATC code: A10BD17 | A10BF01
SMILES: [H]C(=O)[C@H](O)[C@@H](O)[C@]([H])(O[C@@]1([H])O[C@H](CO)[C@@]([H])(O[C@H]2O[C@H](C)[C@@H](N[C@@]3([H])C=C(CO)[C@@H](O)[C@H](O)[C@H]3O)[C@H](O)[C@H]2O)[C@H](O)[C@H]1O)[C@H](O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: 50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
Eligibility criteria:
Inclusion criteria

Patients must give written informed consent before any assessment is performed.
Male, non-fertile female or female of childbearing potential using a medically approved birth control method based on local regulations.
Drug naïve type 2 diabetes patients, defined as who neither take consecutive anti-hyperglycemic drug treatment more than 3 months anytime, nor any anti-hyperglycemic drug treatment in 4 weeks prior to visit 1.
Age in the range of 18-75 years inclusive.
HbA1c in the range of > 6.5 to ≤9.0% at Visit 1.

Exclusion criteria

Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5 mIU/mL).
With known hypersensitivity to Nateglinide, Acarbose or any of the excipients.

A history of,

type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g., Cushing's syndrome and acromegaly.
acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months.
Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation.
percutaneous coronary intervention within the past 3 months.
any of the following within the past 6 months: myocardial infarction (MI), coronary artery bypass surgery, unstable angina, or stroke.
Evidence of significant diabetic complications, e.g., symptomatic autonomic neuropathy or gastroparesis.
Acute infections which may affect blood glucose control within 4 weeks prior to visit 1.
Congestive heart failure requiring pharmacologic treatment. mg/dL (123μmol/L)
Intervention: Bethanechol
Trial phase: Phase 1
ATC code: N07AB02
SMILES: CC(C[N+](C)(C)C)OC(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device

Bethanechol: Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled.
Eligibility criteria:
Inclusion Criteria:

Any adult patient treated at the Medical College of Georgia, with severe IEM as defined using current criteria: esophageal contraction amplitude <30 mmHg either 5 or 10 cm above the lower esophageal sphincter, in 50% or more of saline swallows.

Exclusion Criteria:

Patients with severe comorbidities (including uncontrolled hypertension, severe coronary artery disease, and uncontrolled diabetes) will be specifically excluded from the study.
Additionally, the use of bethanechol (as well as all other muscarinic receptor agonists) is contraindicated in patients with asthma, coronary insufficiency, peptic ulcers, Parkinson's disease, seizure disorder, recent gastrointestinal surgery, and hyperthyroidism. As such any patient with these disorders will be specifically excluded from this study.
Women of childbearing age will also be specifically excluded (Bethanechol is listed as a pregnancy class C drug).
Intervention: Ondansetron
Trial phase: Phase 2
ATC code: A04AA01
SMILES: Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
Eligibility criteria:
Inclusion Criteria:

Patients > 18 years with acute myelogenous leukemia or high-risk myelodysplastic syndrome undergoing chemotherapy with high dose cytarabine (1.5 or 2gm/m^2) containing regimens.
Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

Exclusion Criteria:

Patients with emesis or grade 2 nausea (oral intake is significantly decreased) or 3 nausea (no significant intake requiring intravenous fluids)</= 24 hours before chemotherapy.
Patients with ongoing emesis due to any organic etiology.
Patients with known hypersensitivity to the study drug or to other selective 5-HT3 receptor antagonists.
Intervention: Propofol
Trial phase: Not Applicable
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: standard anesthetic management with propofol 100-150mcg/kg/min
Eligibility criteria:
Inclusion Criteria:

patients with liver tumors undergoing liver resection of > 1 segment liver resection must be performed with inflow occlusion > 30 min

Exclusion Criteria:

patients undergoing liver resection of one segment or less
patients undergoing laparoscopic liver resection
patients in whom the liver resection is performed with no inflow occlusion or inflow occlusion of < 30 min
Intervention: Isoflurane
Trial phase: Not Applicable
ATC code: N01AB06
SMILES: FC(F)OC(Cl)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: preconditioning with isoflurane , anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
Eligibility criteria:
Inclusion Criteria:

patients with liver tumors undergoing liver resection of > 1 segment liver resection must be performed with inflow occlusion > 30 min

Exclusion Criteria:

patients undergoing liver resection of one segment or less
patients undergoing laparoscopic liver resection
patients in whom the liver resection is performed with no inflow occlusion or inflow occlusion of < 30 min
Intervention: Imatinib Mesylate
Trial phase: Phase 3
SMILES: CS(=O)(=O)O.Cc1ccc(NC(=O)c2ccc(CN3CCN(C)CC3)cc2)cc1Nc1nccc(-c2cccnc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL

Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years
Unresectable and/or metastatic GIST
Currently receiving imatinib 400 mg per day for a minimum of 4 weeks prior to registration, and for no more than 6 months prior to registration. This must be the first time that the patient has been treated for metastatic and/or unresectable GIST
For patients who received imatinib following surgery at the time of an initial diagnosis of GIST, there must be a 6 month interval between completion of imatinib and the diagnosis of metastatic GIST
Good physical functioning (ECOG Performance Status of 0 or 1)
Generally, good function of organ such as liver and kidneys

Exclusion Criteria:

Disease progression during adjuvant therapy with imatinib (adjuvant treatment is treatment that is given after surgery for GIST)
Known intolerance of imatinib at a dose of 400 mg/day or higher
Prior systemic therapy for advanced GIST with imatinib or those who have been on imatinib for longer than 6 months for unresectable and/or metastatic disease
Major surgery within 2 weeks prior to Day 1 of study or who have not yet recovered from prior surgery
Use of coumadin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon)
Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation < 2 weeks or who have not recovered from side effects of this therapy
Intervention: Imatinib Mesylate
Trial phase: Phase 3
SMILES: CS(=O)(=O)O.Cc1ccc(NC(=O)c2ccc(CN3CCN(C)CC3)cc2)cc1Nc1nccc(-c2cccnc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Patients with blood level ≥1100 will continue imatinib 400 mg daily

Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years
Unresectable and/or metastatic GIST
Currently receiving imatinib 400 mg per day for a minimum of 4 weeks prior to registration, and for no more than 6 months prior to registration. This must be the first time that the patient has been treated for metastatic and/or unresectable GIST
For patients who received imatinib following surgery at the time of an initial diagnosis of GIST, there must be a 6 month interval between completion of imatinib and the diagnosis of metastatic GIST
Good physical functioning (ECOG Performance Status of 0 or 1)
Generally, good function of organ such as liver and kidneys

Exclusion Criteria:

Disease progression during adjuvant therapy with imatinib (adjuvant treatment is treatment that is given after surgery for GIST)
Known intolerance of imatinib at a dose of 400 mg/day or higher
Prior systemic therapy for advanced GIST with imatinib or those who have been on imatinib for longer than 6 months for unresectable and/or metastatic disease
Major surgery within 2 weeks prior to Day 1 of study or who have not yet recovered from prior surgery
Use of coumadin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon)
Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation < 2 weeks or who have not recovered from side effects of this therapy
Intervention: Dapagliflozin
Trial phase: Phase 3
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 460
Group description: Dapagliflozin, 10 mg tablet, oral, once daily
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes mellitus.
Cardiovascular disease
Hypertension

Exclusion Criteria:

Patients with type 1 diabetes or diabetes insipidus
Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or poorly controlled diabetes
Any clinically significant illness, which would compromise the patient's safety and their participation in the study