anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ganirelix
Trial phase: Phase 3
ATC code: H01CC01
SMILES: CC/N=C(\NCC)NCCCC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CCCCN/C(=N/CC)NCC)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@@H](Cc1cccnc1)NC(=O)[C@@H](Cc1ccc(Cl)cc1)NC(=O)[C@@H](Cc1ccc2ccccc2c1)NC(C)=O)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 112
Group description: 0.25 mg once daily from stimulation day 6 onwards up to the day of human chorionic gonadotropin (hCG).
Eligibility criteria:
Inclusion Criteria:

females of infertile couples for whom COS and IVF or ICSI is indicated
body mass index between 18 and 29 kg/m2
willing and able to give written informed consent.

Exclusion Criteria:

More than three previous COS cycles for assisted reproduction since last established ongoing pregnancy (if applicable)
History of no or low ovarian response to FSH/human menopausal gonadotropin (hMG) treatment
Less than 2 ovaries or any other ovarian abnormality including endometrioma
Presence of unilateral or bilateral hydrosalpinx
Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation of at least one ovary
History of or current polycystic ovary syndrome (PCOS)
History of/or current endocrine abnormality
Any clinically relevant hormone value outside the reference range during the early follicular phase
Any clinically significant abnormal laboratory value
Hypertension or currently treated hypertension
Recent history of current epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary disease
Alcohol or drug abuse, or history thereof
Current serious allergic symptoms
Abnormal cervical smear
Known hypersensitivity to gonadotropin releasing hormone (GnRH) or its analogs;
Contra-indications for the use of gonadotropins
Use of hormonal preparations within 1 month prior to the date of signing consent;
Administration of any investigational product within 3 months prior to screening.
Intervention: Triptorelin
Trial phase: Phase 3
ATC code: L02AE04
SMILES: CC(C)C[C@H](NC(=O)[C@@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1c[nH]cn1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N1CCC[C@H]1C(=O)NCC(N)=O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 120
Group description: 0.05 mg once daily from cycle day 21-24 onwards up to the day of hCG
Eligibility criteria:
Inclusion Criteria:

females of infertile couples for whom COS and IVF or ICSI is indicated
body mass index between 18 and 29 kg/m2
willing and able to give written informed consent.

Exclusion Criteria:

More than three previous COS cycles for assisted reproduction since last established ongoing pregnancy (if applicable)
History of no or low ovarian response to FSH/human menopausal gonadotropin (hMG) treatment
Less than 2 ovaries or any other ovarian abnormality including endometrioma
Presence of unilateral or bilateral hydrosalpinx
Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation of at least one ovary
History of or current polycystic ovary syndrome (PCOS)
History of/or current endocrine abnormality
Any clinically relevant hormone value outside the reference range during the early follicular phase
Any clinically significant abnormal laboratory value
Hypertension or currently treated hypertension
Recent history of current epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary disease
Alcohol or drug abuse, or history thereof
Current serious allergic symptoms
Abnormal cervical smear
Known hypersensitivity to gonadotropin releasing hormone (GnRH) or its analogs;
Contra-indications for the use of gonadotropins
Use of hormonal preparations within 1 month prior to the date of signing consent;
Administration of any investigational product within 3 months prior to screening.
Intervention: Aplaviroc
Trial phase: Phase 1 | Phase 2
SMILES: [H][C@]1([C@H](O)C2CCCCC2)NC(=O)C2(CCN(Cc3ccc(Oc4ccc(C(=O)O)cc4)cc3)CC2)N(CCCC)C1=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: trastuzumab (Herceptin®) : About 1 week (4 - 7 days) before scheduled breast surgery, consisting of lumpectomy or mastectomy, subjects will receive a dose of trastuzumab (Herceptin®). Trastuzumab will be given through an IV or port for approximately 90 minutes. During this time, subjects will be closely monitored by a chemotherapy nurse to make sure that subjects do not have a reaction to the medication. It is possible that the infusion of the medication will need to be slowed down, in which case, the time for the infusion will be longer than 90 minutes. The one dose of the trastuzumab drug will be provided by the study (not billed to insurance), but the charges to administer the drug will be billed to subjects or subjects health insurance.
Eligibility criteria:
Inclusion Criteria:

Women who have Her-2 positive and ER- negative or ER-low breast cancer that has not metastasized, or spread to other parts of the body, are eligible for the study.
Participants must have had either a core biopsy or incisional biopsy of their breast cancer, but not yet had definitive breast surgery, including lumpectomy or mastectomy.
Participants may not have had a BRCA mutation found on genetic testing.

Participants should have not yet received treatment for their breast cancer, including:

chemotherapy,
hormonal therapy,
trastuzumab.
Intervention: Indomethacin
Trial phase: Not Applicable
ATC code: C01EB03 | M01AB01 | M01AB51 | M02AA23 | S01BC01 | S01CC02
SMILES: COc1ccc2c(c1)c(CC(=O)O)c(C)n2C(=O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 117
Group description: Indomethacin liquid suspension 100 mg (25 mg/5ml) which is 20 cc of suspension instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.

Indomethacin: Indomethacin 100 mg liquid suspension (25 mg/5 ml) which is 20 cc of suspension is instilled via a Teflon catheter (the end of which is passed through the biopsy channel of the endoscope) and situated into the duodenum. Following instillation of the suspension, the catheter is flushed with 5 cc of normal saline.
Eligibility criteria:
Inclusion Criteria:

Patients undergoing ERCP as part of their clinical care.

Exclusion Criteria:

Pancreatitis within 60 days of ERCP
Age less than 18 years
Pregnant patients
Patients who have received NSAIDs within the past 7 days
Patients with a previous allergy to NSAIDs
Patients who were previously enrolled in the study
Patients with a history of peptic ulcers, gastrointestinal bleeding, on anticoagulants and/or with a bleeding diathesis.
Intervention: Omeprazole
Trial phase: Phase 2 | Phase 3
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks for subjects with positive 24 hour pH study
Eligibility criteria:
Inclusion Criteria:

Patients ages 18-80.
Patients who carry the diagnosis of Eosinophilic Esophagitis (EE) based on esophageal biopsies obtained within 18 months prior to enrollment with greater than 15 eosinophils (eos) per high power field (hpf) (400 X magnification).
Patients who have moderate, severe, or very severe problems swallowing.

Exclusion Criteria:

Patients who are currently being treated for EE.
Patients who have used topical or systemic corticosteroid therapy for any reason over the past 4 weeks.
Patients who have been treated with acid-suppressing medications (Proton Pump Inhibitor or H2 receptor antagonists) within 4 weeks prior to enrollment.
Patients with known allergies or hypersensitivity to proton-pump inhibitors or corticosteroids.
Patients who have contraindications to the procurement of biopsies including patients how have known bleeding disorders, a history of bleeding diathesis, or who are currently using warfarin or clopidogrel.
Patients who have a contraindication to the performance of an esophagogastroduodenoscopy (EGD) including previous cardiopulmonary arrest during an endoscopic procedure.
Patients who have contraindications to the performance of ambulatory impedance 24-hour pH testing including patients with oropharyngeal abnormalities that would prohibit the safe passage of the transnasal catheter and patients who are currently using warfarin, have a history of bleeding disorders or bleeding diatheses.
Patients who are pregnant.
Intervention: Budesonide
Trial phase: Phase 2 | Phase 3
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose [Splenda-registered trademark]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)
Eligibility criteria:
Inclusion Criteria:

Patients ages 18-80.
Patients who carry the diagnosis of Eosinophilic Esophagitis (EE) based on esophageal biopsies obtained within 18 months prior to enrollment with greater than 15 eosinophils (eos) per high power field (hpf) (400 X magnification).
Patients who have moderate, severe, or very severe problems swallowing.

Exclusion Criteria:

Patients who are currently being treated for EE.
Patients who have used topical or systemic corticosteroid therapy for any reason over the past 4 weeks.
Patients who have been treated with acid-suppressing medications (Proton Pump Inhibitor or H2 receptor antagonists) within 4 weeks prior to enrollment.
Patients with known allergies or hypersensitivity to proton-pump inhibitors or corticosteroids.
Patients who have contraindications to the procurement of biopsies including patients how have known bleeding disorders, a history of bleeding diathesis, or who are currently using warfarin or clopidogrel.
Patients who have a contraindication to the performance of an esophagogastroduodenoscopy (EGD) including previous cardiopulmonary arrest during an endoscopic procedure.
Patients who have contraindications to the performance of ambulatory impedance 24-hour pH testing including patients with oropharyngeal abnormalities that would prohibit the safe passage of the transnasal catheter and patients who are currently using warfarin, have a history of bleeding disorders or bleeding diatheses.
Patients who are pregnant.
Intervention: Disulfiram
Trial phase: Phase 1 | Phase 2
ATC code: N07BB01 | P03AA04 | P03AA54
SMILES: CCN(CC)C(=S)SSC(=S)N(CC)CC
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 52
Group description: disulfiram

disulfiram: 250mg daily
Eligibility criteria:
Inclusion Criteria:

1. Meet DSM IV criteria for cocaine dependence; 2. Have a self-reported history of using cocaine by the smoked or IV route. Participants must report at least weekly use for the past month and have a cocaine-positive urine test in the week of study entry; 3. Have vital signs after a 48 hours washout period as follows: resting pulse between 50 and 80 bpm, blood pressures between 105-130mm Hg systolic and 45-80mm Hg diastolic; 4. Have hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions: a) liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) < 3 x the upper limit of normal, and b) kidney function tests (creatinine and BUN) < 2 x the upper limit of normal; 5. Have a baseline ECG that demonstrates normal sinus rhythm, normal conduction, and no clinically significant arrhythmias; and 6. Have a medical history and standard physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the principal investigator.

Exclusion Criteria:

1. Have any history or evidence suggestive of seizures or brain injury 2. Have any previous medically adverse reaction to cocaine, including loss of consciousness, chest pain, or epileptic seizure; 3. Have neurological or psychiatric disorders, such as:

psychosis, bipolar illness or major depression as assessed by MINI (or SCID if necessary);
organic brain disease or dementia assessed by clinical interview;
history of any psychiatric disorder which would require ongoing treatment or which would make study compliance difficult;

history of suicide attempts within the past three months assessed by MINI and/or current suicidal ideation/plan as assessed by MINI; 4. Have evidence of clinically significant heart disease or hypertension, as determined by the PI; 5. Have a family history in first degree relatives of early cardiovascular morbidity or mortality, as determined by the PI; 6. Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease; 7. Have HIV and are currently symptomatic, have a diagnosis of AIDS, or are receiving antiretroviral medication; 8. Have any history of asthma, chronic coughing and wheezing, or other respiratory illnesses; 9. Heavy current alcohol intake that is likely to lead to withdrawal symptoms, in the opinion of the PI; 10. Refuse to abstain from alcohol during the protocol and for at least one week after discharge.

11. Have any other illness, condition, or use of medications, which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of the study.
Intervention: Lovaza
Trial phase: Phase 3
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)OCC.CCC=CCC=CCC=CCC=CCC=CCCCC(=O)OCC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 180
Group description: Participants will receive a highly purified form of omega-3 fatty acids for 6 months.

Omega-3 Fatty Acids (Fish Oil Supplements): 4 grams of omega-3 fatty acids taken orally once per day for 6 months
Eligibility criteria:
Inclusion Criteria:

Experienced a heart attack in the 2 to 4 weeks before study entry
Lives in the greater Boston area or adjacent regions (within a 50-mile radius of Boston)

Exclusion Criteria:

Unable to undergo an MRI because of metallic implants (e.g., pacemakers, an implantable cardioverter defibrillator [AICD]) at time of study entry
Active cancer or any other terminal illness with an expected survival rate of less than 6 months after study entry
Significant kidney dysfunction with a glomerular filtration rate (GFR) of less than 60 mL/min in the 2 weeks before study entry
Inability to follow study procedures
Pregnant
Hemodynamic instability
Urgent clinical need for a pacemaker or AICD
Inaccessibility of medical records
Intervention: Ospemifene
Trial phase: Phase 3
ATC code: G03XC05
SMILES: OCCOc1ccc(/C(=C(/CCCl)c2ccccc2)c2ccccc2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 463
Group description: Subjects received a single, oral dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. All subjects were provided with vaginal lubricant (K-Y® Brand), which was used as needed.
Eligibility criteria:
Inclusion Criteria:

Naturally or surgically menopausal
Moderate or severe symptoms of vaginal atrophy
5% or fewer superficial cells in maturation index of vaginal smear
Vaginal pH greater than 5.0
Self reported Most Bothersome Symptom of vaginal dryness or vaginal pain associated with sexual activity, with a severity of moderate or severe at randomization

Exclusion Criteria:

Uterine bleeding of unknown origin, uterine polyps or symptomatic and/or large uterine fibroids
Current vaginal infection requiring medication
Clinically significant abnormal gynecological findings other than signs of vaginal atrophy (e.g.

uterine or vaginal prolapse of Grade 2 or higher)

Previous participation in any other ospemifene study
Intervention: Everolimus
Trial phase: Phase 2
ATC code: L01EG02 | L04AA18
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(OCCO)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Treatment Arm (RAD001)
Eligibility criteria:
Inclusion Criteria:

Patients must have histologically or cytologically documented stomach adenocarcinoma including adenocarcinoma of the esophagogastric junction
Patients must have non-resectable disease by metastasis or recurrent disease after curative surgical resection with uni-dimensionally measurable disease (at least longest diameter 1 cm on computed tomography scan, or at least 2 cm on chest x-ray or physical examination)
Patients tumor should have failure of 1st line chemotherapy including fluoropyrimidine (5-FU, capecitabine, doxifluridine, S1, or UFT) and platinum (cisplatin, carboplatin, or oxaliplatin) in palliative setting; progression during or within 6 months after chemotherapy
Age 18 to 75 years old
Estimated life expectancy of more than 3 months
ECOG performance status of 2 or lower
Adequate bone marrow function
Adequate kidney function
Adequate liver function
No prior radiation therapy to more than 25 percent of BM
Patients must not have psychological, familial, sociological or geographical conditions which do not permit medical follow-up and compliance with this study
Women of childbearing potential must have a negative pregnancy test on admission
The patient must be able to understand the study and has given written informed consent to participate in the study

Exclusion Criteria:

Other tumor types than adenocarcinoma
Central nervous system metastases or prior radiation for CNS metastasis
Gastric outlet obstruction or intestinal obstruction
Evidence of active gastrointestinal bleeding
Bony metastasis as the sole evaluable disease
Past or concurrent history of neoplasm other than stomach cancer
Pregnant or lactating women, women of childbearing potential not employing adequate contraception
Thyroid disease
Intervention: Pregabalin
Trial phase: Phase 3
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: Multi-dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery and then repeat 150 mg doses at 12 and 24 hours after initial dose.
Eligibility criteria:
Inclusion Criteria:

History of osteoarthritis
Subjects who can understand and communicate in English

Exclusion Criteria:

Younger than 55 years or older than 75 years.
American Society of Anesthesiologists physical status IV
Prior use of pregabalin or gabapentin will not be an exclusionary criterion; however patients will have been withdrawn from these medications at least 14 days before surgery
Patients who are currently enrolled in another investigational study.
Intervention: Pregabalin
Trial phase: Phase 3
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: Single dose pregabalin: patients receive pregabalin 150 mg orally 1 hour prior to surgery, and then placebo doses at 12 and 24 hours after initial dose.
Eligibility criteria:
Inclusion Criteria:

History of osteoarthritis
Subjects who can understand and communicate in English

Exclusion Criteria:

Younger than 55 years or older than 75 years.
American Society of Anesthesiologists physical status IV
Prior use of pregabalin or gabapentin will not be an exclusionary criterion; however patients will have been withdrawn from these medications at least 14 days before surgery
Patients who are currently enrolled in another investigational study.
Intervention: Raltegravir
Trial phase: Phase 2 | Phase 3
ATC code: J05AJ01 | J05AR16 | J05AX08
SMILES: Cc1nnc(C(=O)NC(C)(C)c2nc(C(=O)NCc3ccc(F)cc3)c(O)c(=O)n2C)o1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: Raltegravir a single 400 mg pill taken orally every 12 hours for a total of 7 days.
Eligibility criteria:
Inclusion criteria:

Able to give informed consent.
Negative HIV-1 serology.
At least 18 but no more than 55 years of age.
Body mass index <30.
Estimated creatinine clearance ≥ 50 mL/minute within 30 days prior to study entry.

Within 30 days prior to study entry:

Absolute neutrophil count ≥ 1,000/mm3.
Hemoglobin ≥ 12.5 g/dL for males and ≥ 11.5 g/dL for females.
Platelet count ≥ 100,000/mm3.
AST, ALT, and total bilirubin within normal range.
Alkaline phosphatase < or = 1.5 x upper limit of normal.
Female study volunteers of reproductive potential must have a negative serum or urine pregnancy test performed within 30 days before study entry.
Must agree not to participate in a conception process.
Drug transporter gene ABCB1 position 3435 genotype C/C or T/T.

Exclusion criteria:

Use of any medication that is metabolized by CYP3A or UGT1A1.
Anticipated need to take any medication that is metabolized by CYP3A or UGT1A1 during the study.
Active drug use or dependence.
Inability to abstain from alcohol-containing beverages, grapefruit, and grapefruit juice.
Serious illness that would interfere with study participation.
Hospitalization for any reason or therapy for serious illness within 14 days prior to study entry.
History of hypersensitivity to study drug or its formulation.
As determined by the investigator, a significant active or previous history of cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, or immunologic disease(s). This is inclusive of chronic illnesses such as hypertension, coronary artery disease, arthritis, diabetes, any chronic gastrointestinal conditions that may affect drug absorption, etc.
Breast-feeding.
Evidence of CNS infection or space occupying lesion by history or physical examination.
History of significant CNS disorder.
Prisoners or subjects who are compulsorily detained.
ABCB1 position 3435 C/T heterozygosity.
Intervention: Sitagliptin
Trial phase: Phase 1
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 9
Group description: Participants who received a single oral dose of sitagliptin 100 mg.
Eligibility criteria:
Inclusion Criteria:

Males or females who are 10 - 17 years of age
History of type 2 diabetes
Nonsmoker
No clinical or laboratory evidence to indicate a diagnosis of type 1 diabetes

Exclusion Criteria:

History of diabetic ketoacidosis
History of stroke, chronic seizures or major neurological disorder
Consumes alcohol
Consume more than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola or other beverages containing caffeine per day
Unable to swallow tablets
Has had surgery, donated or lost 1 unit of blood, or participated in another investigational study within a minimum of 4 weeks prior to starting the study
History of multiple and/or severe allergies or has had an allergic reaction to or significant intolerability to prescription or non-prescription drugs or food
Currently a regular user of any illicit drugs or has a history of drug or alcohol abuse
History of clinically significant endocrine, gastrointestinal,

cardiovascular, hematological, hepatic, immunological, renal, respiratory, or

genitourinary abnormalities or diseases

Has an estimated creatinine clearance of less than or equal to 80 mL/min