anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Alprazolam
Trial phase: Phase 1
ATC code: N05BA12
SMILES: Cc1nnc2n1-c1ccc(Cl)cc1C(c1ccccc1)=NC2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
Eligibility criteria:
Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 55 years.
Recreational polydrug user with a history of CNS depressant use.

Exclusion Criteria:

History of clinically significant neurologic condition(s), such as seizures, convulsions, epilepsy, or significant head injury, as judged by the investigator or designee.
A known history of hypersensitivity or previous intolerance to dimebon or other antihistamines.
Self-reported history of drug or alcohol dependence (except nicotine or caffeine) in the 2 years prior to screening, or drug or alcohol dependence as defined by the (DSM-IV-TR) in 12 months prior to screening, including subjects who have ever been in a substance rehabilitation program (other than treatment for smoking cessation).
History of clinically significant psychiatric disorder(s), as judged by the investigator or qualified designee.
Intervention: Latrepirdine
Trial phase: Phase 1
SMILES: Cc1ccc2c(c1)c1c(n2CCc2ccc(C)nc2)CCN(C)C1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
Eligibility criteria:
Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 55 years.
Recreational polydrug user with a history of CNS depressant use.

Exclusion Criteria:

History of clinically significant neurologic condition(s), such as seizures, convulsions, epilepsy, or significant head injury, as judged by the investigator or designee.
A known history of hypersensitivity or previous intolerance to dimebon or other antihistamines.
Self-reported history of drug or alcohol dependence (except nicotine or caffeine) in the 2 years prior to screening, or drug or alcohol dependence as defined by the (DSM-IV-TR) in 12 months prior to screening, including subjects who have ever been in a substance rehabilitation program (other than treatment for smoking cessation).
History of clinically significant psychiatric disorder(s), as judged by the investigator or qualified designee.
Intervention: Latrepirdine
Trial phase: Phase 1
SMILES: Cc1ccc2c(c1)c1c(n2CCc2ccc(C)nc2)CCN(C)C1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
Eligibility criteria:
Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 55 years.
Recreational polydrug user with a history of CNS depressant use.

Exclusion Criteria:

History of clinically significant neurologic condition(s), such as seizures, convulsions, epilepsy, or significant head injury, as judged by the investigator or designee.
A known history of hypersensitivity or previous intolerance to dimebon or other antihistamines.
Self-reported history of drug or alcohol dependence (except nicotine or caffeine) in the 2 years prior to screening, or drug or alcohol dependence as defined by the (DSM-IV-TR) in 12 months prior to screening, including subjects who have ever been in a substance rehabilitation program (other than treatment for smoking cessation).
History of clinically significant psychiatric disorder(s), as judged by the investigator or qualified designee.
Intervention: Latrepirdine
Trial phase: Phase 1
SMILES: Cc1ccc2c(c1)c1c(n2CCc2ccc(C)nc2)CCN(C)C1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
Eligibility criteria:
Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 55 years.
Recreational polydrug user with a history of CNS depressant use.

Exclusion Criteria:

History of clinically significant neurologic condition(s), such as seizures, convulsions, epilepsy, or significant head injury, as judged by the investigator or designee.
A known history of hypersensitivity or previous intolerance to dimebon or other antihistamines.
Self-reported history of drug or alcohol dependence (except nicotine or caffeine) in the 2 years prior to screening, or drug or alcohol dependence as defined by the (DSM-IV-TR) in 12 months prior to screening, including subjects who have ever been in a substance rehabilitation program (other than treatment for smoking cessation).
History of clinically significant psychiatric disorder(s), as judged by the investigator or qualified designee.
Intervention: Vorinostat
Trial phase: Phase 1 | Phase 2
ATC code: L01XH01
SMILES: O=C(CCCCCCC(=O)Nc1ccccc1)NO
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.

Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.

Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD.
Eligibility criteria:
Inclusion Criteria:

Subjects with a histologic or cytologic diagnosis of stage III/IV ovarian cancer, fallopian tube epithelial cancer, or peritoneal cancer who have not received prior chemotherapy or radiotherapy.
Subjects must have the appropriate surgery for their gynecologic cancer. However, subjects may be treated in a neoadjuvant manner, with surgery being performed after chemotherapy cycles 1, 2, or 3.
If neoadjuvant therapy is not administered, subjects must receive their first dose no more than six weeks postoperatively.
Subjects must have adequate bone marrow, renal and hepatic function as defined by WBC > 3,000 cells/cu ml., platelets > 100,000/cu.ml., calculated creatinine clearance > 50 ccs/min., bilirubin < 1.5 mg/dl, and SGOT < three times normal.
Karnofsky performance status > 50%.
Subjects who have signed an institutional review board (IRB) approved informed consent form.

Exclusion Criteria:

Subjects with epithelial ovarian cancer of low malignancy potential.
Subjects with septicemia, severe infection, or acute hepatitis.
Subjects with a history of congestive heart failure, angina, or a history of myocardial infarction within the past six months.
Intervention: Cholecalciferol
Trial phase: Phase 1
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Subjects received Cholecalciferol 20,000 IU weekly 1 year
Eligibility criteria:
Inclusion Criteria:

Elevated risk of breast cancer defined as having at least one of the following: (1) Predicted 5-year modified Gail model risk of 1.7% or greater, (2) Lobular carcinoma in situ, (3) Known BRCA1 or BRCA2 deleterious mutation carrier, (4) Prior history of ductal carcinoma in situ, if no current tamoxifen use or prior radiation to the contralateral breast.
Age 21 years or older.
Premenopausal defined as < 6 months since the last menstrual period, no prior bilateral oophorectomy, not on estrogen replacement, and serum Follicle-stimulating hormone (FSH) values consistent with institutional normal values for the premenopausal state.
Normal breast exam and mammogram (BIRADS score of 1 or 2).
Baseline mammographic density ≥25% as assessed qualitatively by the mammographer (25-50% = "scattered fibroglandular densities"; >50-75% = "heterogeneously dense breasts"; >75% = "extremely dense breasts").
Baseline serum 25-hydroxyvitamin D <32 ng/ml.
Prior tamoxifen use is allowed provided treatment is discontinued at least 28 days prior to enrollment.
Willingness to allow submission of core needle breast biopsy for pathology review and collection of blood for biomarker analysis and banking.
At least one breast available for imaging and biopsy.
Willingness to not take calcium or vitamin D supplements during the one year intervention, due to the potential risk of hypercalcemia/hypercalciuria with high dose vitamin D. Premenopausal women who need to take calcium supplementation for any medical condition will be excluded from the study. Dietary restrictions on calcium intake may be imposed if the subject is found to have borderline high serum or urine levels of calcium during the study intervention and a list of dietary sources of calcium will be provided.
Normal serum calcium.
No history of kidney stones.
Adequate renal and hepatic function: serum creatinine, bilirubin, aspartate aminotransferase (AST), alanine transaminase (ALT) and alkaline phosphatase < 2.0 x the institutional upper limit of normal (IULN).
No hypersensitivity reactions to vitamin D.
Performance status of 0 or 1.
Not pregnant or nursing.
Agree to use effective contraception, hormone-based oral contraceptives allowed but switching birth control methods is discouraged while on-study.
No significant medical or psychiatric condition that would preclude study completion.

Exclusion Criteria:

Not meeting one or any of inclusion criteria
Intervention: Cholecalciferol
Trial phase: Phase 1
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Subjects received Cholecalciferol 30,000 IU weekly 1 year
Eligibility criteria:
Inclusion Criteria:

Elevated risk of breast cancer defined as having at least one of the following: (1) Predicted 5-year modified Gail model risk of 1.7% or greater, (2) Lobular carcinoma in situ, (3) Known BRCA1 or BRCA2 deleterious mutation carrier, (4) Prior history of ductal carcinoma in situ, if no current tamoxifen use or prior radiation to the contralateral breast.
Age 21 years or older.
Premenopausal defined as < 6 months since the last menstrual period, no prior bilateral oophorectomy, not on estrogen replacement, and serum Follicle-stimulating hormone (FSH) values consistent with institutional normal values for the premenopausal state.
Normal breast exam and mammogram (BIRADS score of 1 or 2).
Baseline mammographic density ≥25% as assessed qualitatively by the mammographer (25-50% = "scattered fibroglandular densities"; >50-75% = "heterogeneously dense breasts"; >75% = "extremely dense breasts").
Baseline serum 25-hydroxyvitamin D <32 ng/ml.
Prior tamoxifen use is allowed provided treatment is discontinued at least 28 days prior to enrollment.
Willingness to allow submission of core needle breast biopsy for pathology review and collection of blood for biomarker analysis and banking.
At least one breast available for imaging and biopsy.
Willingness to not take calcium or vitamin D supplements during the one year intervention, due to the potential risk of hypercalcemia/hypercalciuria with high dose vitamin D. Premenopausal women who need to take calcium supplementation for any medical condition will be excluded from the study. Dietary restrictions on calcium intake may be imposed if the subject is found to have borderline high serum or urine levels of calcium during the study intervention and a list of dietary sources of calcium will be provided.
Normal serum calcium.
No history of kidney stones.
Adequate renal and hepatic function: serum creatinine, bilirubin, aspartate aminotransferase (AST), alanine transaminase (ALT) and alkaline phosphatase < 2.0 x the institutional upper limit of normal (IULN).
No hypersensitivity reactions to vitamin D.
Performance status of 0 or 1.
Not pregnant or nursing.
Agree to use effective contraception, hormone-based oral contraceptives allowed but switching birth control methods is discouraged while on-study.
No significant medical or psychiatric condition that would preclude study completion.

Exclusion Criteria:

Not meeting one or any of inclusion criteria
Intervention: Carboplatin
Trial phase: Phase 3
ATC code: L01XA02
SMILES: [H]N([H])([H])->[Pt]1(<-N([H])([H])[H])OC(=O)C2(CCC2)C(=O)O1
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 134
Group description: Bevacizumab + Pemetrexed + Carboplatin

Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks
Eligibility criteria:
Inclusion Criteria:

Stage IIIb and IV NSCLC, excluded squamous cell NSCLC
Age ≥ 65 years
ECOG 0-2

Exclusion Criteria:

Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component
History of haemoptysis
Evidence of tumour invading major blood vessels on imaging
Radiotherapy within 28 days prior to enrolment
Patients who are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose ≤ 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
Current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed
Clinically significant (i.e. active) cardiovascular disease for example CVA (≤6 months before enrolment), myocardial infarction (≤6 months before enrolment), unstable angina, CHF NYHA Class ≥II, serious cardiac arrhythmia requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication
Non-healing wound, active peptic ulcer or bone fracture
History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment
Intervention: Celecoxib
Trial phase: Phase 3
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
Eligibility criteria:
Inclusion Criteria:

Patients with posttraumatic pain which is able to be controlled with an oral NSAID
Patients with "pain" that meets both of the following criteria within 48 hours after injury:

"Pain" Pain intensity (Categorical): "Moderate pain" or "Severe pain" Pain intensity (VAS): 45.0 mm or more

Patients with "inflammation" that meets the following criteria within 48 hours after injury.

"Inflammation" Categorical: "Mild", "Moderate" or "Severe"

Exclusion Criteria:

Patients who have received analgesics and anaesthetics for injury
Patients with a history/complication of aspirin-induced asthma
Patients taking excluded medications
Patients with a history/complication of ischaemic heart disease, serious cardiac arrhythmias, cardiac failure congestive and cerebrovascular disorder or with a history/plan of revascularization
Intervention: OXYTOCIN
Trial phase: Phase 4
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: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 26
Group description: oxytocin 5 u : Hemodynamic effect of
Eligibility criteria:
Inclusion Criteria:

Healthy pregnant women for planned cesarean section

Exclusion Criteria:

Bleeding disorders
Placenta disorders
Intervention: Rosuvastatin
Trial phase: Phase 2
ATC code: A10BH52 | C10AA07 | C10BA06 | C10BA09 | C10BX05 | C10BX07 | C10BX09 | C10BX10 | C10BX13 | C10BX14 | C10BX16 | C10BX17 | G01AE10
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Rosuvastatin

Rosuvastatin: Loading dose 40mg by mouth first day, then 20 mg by mouth for up to 27 days
Eligibility criteria:
Inclusion Criteria:

Thermal burn occurring within the 96 hours prior to dosing

Exclusion Criteria:

Inability to obtain informed consent (or assent from surrogate)
Less than 18 years of age
Patient or surrogate not committed and/or not likely to remain committed to full support, as, for example, would be the case for a patient with end-stage cancer or other end-stage terminal conditions. Commitment to full support need not include cardiopulmonary resuscitation provided the team is committed to other forms of full support
Unable to receive or absorb enteral study drug
Statin specific exclusions
Receiving a statin medication within 48 hours of dosing (to exclude controls from exposure to statins)
Allergy or intolerance to statins
ALT or AST > 5 times upper limit of normal
Untreated hypothyroidism by history (package insert)
Pregnancy or breastfeeding
Receiving niacin, fenofibrate, cyclosporine, gemfibrozil, lopinavir, ritonavir or oral contraceptives within 24 hours prior to admission (package insert)
Advanced cirrhosis, defined as a history of chronic liver disease and a Child-Pugh Class score >10 (Appendix A)
Moribund patient not expected to survive 24 hours
Patients admitted to the Burn Service for non-thermal burn conditions, including chemical burn, TENS, electrical injury or wound care
Patient expected to be discharged within 24 hours
Patients of Asian descent (due to pharmacokinetics issues with Rosuvastatin in this population)
Patients receiving another interventional investigational drug within the 30 days prior to dosing
Patients otherwise unsuitable for participation in the opinion of the investigator.
Intervention: Ketamine
Trial phase: Phase 4
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Ketamine: 0.25 mg/kg, intravenously, one dose.
Eligibility criteria:
Inclusion Criteria:

Age: 21 or older
Planned liver resection with Pringle maneuver lasting 30-60 minutes

Exclusion Criteria:

Chronic illness requiring corticosteroids
Cirrhosis
Hemodynamic instability prior to surgery
Diabetes
Sepsis
Surgical interventions or chemotherapy treatments within the past 30 days
Pregnancy
Illnesses that could potentially affect the hepatic circulation
Arterial hypertension
Ocular hypertension
Allergy to ketamine
Preoperative portal embolization
Radiofrequency ablation
Patients requiring emergency surgeries
Intervention: ABSK-091
Trial phase: Phase 1
SMILES: COc1cc(CCc2cc(NC(=O)c3ccc(N4C[C@@H](C)N[C@@H](C)C4)cc3)n[nH]2)cc(OC)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Dose expansion phase (80mg bd tablet)
Eligibility criteria:
Inclusion Criteria:

Minimum life expectancy of 12 weeks
The presence of a solid, malignant tumour that is resistance to standard therapies or for which no standard therapies exist
In the expansion for the study patients must have a tumour at least 1cm in size that can be measure using a CT or MRI scan, and provide a tumour sample to the sponsor company for testing of FGFR1 and/or 2 amplification
Expansion, 5 groups of advanced cancer
Solid tumours,FGFR1 and/or FGFR2 gene amplified
Squamous NSCLC, FGFR1 gene low & high amplified
Gastric adenocarcinoma, including the lower oesophagus/gastro-oesophageal junction, FGFR2 gene low & high amplified
Aged at least 25 years

Exclusion Criteria:

Treatment with any other chemotherapy, immunotherapy or anticancer agents within 3 weeks before the first dose of study
An inability to be able to take the study medication
A bad reaction to AZD4547 or any drugs similar to it in structure or class.
Intervention: ABSK-091
Trial phase: Phase 1
SMILES: COc1cc(CCc2cc(NC(=O)c3ccc(N4C[C@@H](C)N[C@@H](C)C4)cc3)n[nH]2)cc(OC)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Dose escalation
Eligibility criteria:
Inclusion Criteria:

Minimum life expectancy of 12 weeks
The presence of a solid, malignant tumour that is resistance to standard therapies or for which no standard therapies exist
In the expansion for the study patients must have a tumour at least 1cm in size that can be measure using a CT or MRI scan, and provide a tumour sample to the sponsor company for testing of FGFR1 and/or 2 amplification
Expansion, 5 groups of advanced cancer
Solid tumours,FGFR1 and/or FGFR2 gene amplified
Squamous NSCLC, FGFR1 gene low & high amplified
Gastric adenocarcinoma, including the lower oesophagus/gastro-oesophageal junction, FGFR2 gene low & high amplified
Aged at least 25 years

Exclusion Criteria:

Treatment with any other chemotherapy, immunotherapy or anticancer agents within 3 weeks before the first dose of study
An inability to be able to take the study medication
A bad reaction to AZD4547 or any drugs similar to it in structure or class.