anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Colchicine
Trial phase: Phase 1
ATC code: M04AC01
SMILES: COc1cc2c(c(OC)c1OC)-c1ccc(OC)c(=O)cc1[C@@H](NC(C)=O)CC2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30am after an overnight fast, followed by a washout period of 14 days.
Eligibility criteria:
Inclusion Criteria:

Healthy adults 18-45 years of age, non-smoking and non-pregnant (postmenopausal, surgically sterile or using effective contraceptive measures) with a body mass index (BMI) greater than or equal to 18 and less than or equal to 32, inclusive

Exclusion Criteria:

Recent participation (within 28 days) in other research studies
Recent significant blood donation
Pregnant or lactating
Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
Recent (2-year) history or evidence of alcoholism or drug abuse
History or presence of significant cardiovascular, pulmonary, hepatic, gall bladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
Intervention: Colchicine
Trial phase: Phase 1
ATC code: M04AC01
SMILES: COc1cc2c(c(OC)c1OC)-c1ccc(OC)c(=O)cc1[C@@H](NC(C)=O)CC2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
Eligibility criteria:
Inclusion Criteria:

Healthy adults 18-45 years of age, non-smoking and non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures) with a body mass index (BMI) greater than or equal to 18 and less than or equal to 32, inclusive.

Exclusion Criteria:

Recent participation (within 28 days) in other research studies
Recent significant blood donation or plasma donation
Pregnant or lactating
Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
Recent (2-year) history or evidence of alcoholism or drug abuse
History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
Drug allergies to colchicine or diltiazem.
Intervention: Colchicine
Trial phase: Phase 1
ATC code: M04AC01
SMILES: COc1cc2c(c(OC)c1OC)-c1ccc(OC)c(=O)cc1[C@@H](NC(C)=O)CC2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
Eligibility criteria:
Inclusion Criteria:

Healthy adults 18-45 years of age, non-smoking and non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures) with a body mass index (BMI) greater than or equal to 18 and less than or equal to 32, inclusive.

Exclusion Criteria:

Recent participation (within 28 days) in other research studies
Recent significant blood donation or plasma donation
Pregnant or lactating
Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
Recent (2-year) history or evidence of alcoholism or drug abuse
History or presence of significant cardiovascular, hyperlipidemia, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease
Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
Intervention: Clofarabine
Trial phase: Phase 1 | Phase 2
ATC code: L01BB06
SMILES: [H][C@]1(F)[C@H](O)[C@@H](CO)O[C@H]1n1cnc2c(N)nc(Cl)nc21
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Alemtuzumab: Dose escalation (3mg, 10mg, to 30mg) Clofarabine: Maximum Tolerated Dose (10 mg/m2, 20 mg/m2, 30mg/m2, to 40 mg/m2 days 5-9)
Eligibility criteria:
Inclusion Criteria:

Provide signed written informed consent. If a patient is under the 18 years of age the parent or the guardian will also need to provide written informed consent.
Diagnosis of ALL (B or T lineage) who have received therapy with at least 1 but not more than 3 prior different induction regimens and have been deemed to have relapse or refractory disease. The phase II component of the study enrollment will be limited to 2 different prior induction regimens if patients are older than 30 years.
ALL lymphoblasts with CD52 expression on at least 10% on lymphoblasts.
Age >= 16 years of age.
ECOG PS 0-2.
Have adequate renal and hepatic functions.
Subject or their patient or guardian is capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment. Subjects 16 and 17 years old must also adhere to effective contraception methods or abstinence during the study and for a minimum of 6 months after study and the nature of contraception or abstinence must be documented.
CMV PCR negative prior to enrollment

Exclusion Criteria:

Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea, CNS treatment or prophylaxis, or tyrosine kinase inhibitors for individuals with Philadelphia chromosome positive ALL. The patient must have recovered from all acute toxicities from any previous therapy.
Lack of bone marrow or blood involvement by leukemia such as a documented CNS or testicular only relapse.
Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment.
Patients with any known or suspected Hepatitis B, C and HIV infections.
Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
Pregnant or lactating patients.
Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
Intervention: Cyclosporine
Trial phase: Phase 4
ATC code: L04AD01 | S01XA18
SMILES: CC=CCC(C)C(O)C1C(=O)NC(CC)C(=O)N(C)CC(=O)N(C)C(CC(C)C)C(=O)NC(C(C)C)C(=O)N(C)C(CC(C)C)C(=O)NC(C)C(=O)NC(C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(C(C)C)C(=O)N1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants

Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID
Eligibility criteria:
Inclusion Criteria:

Cadaveric or Living Donors
18 years old or greater
Primary renal transplants
Hispanic ethnicity

Exclusion Criteria:

Prior renal transplant
Multi-organ transplant
Recipient with history of Diabetes Mellitus
PRA > 20%
Cold Ischemia Time > 24 hours
Intervention: Tacrolimus
Trial phase: Phase 4
ATC code: D11AH01 | L04AD02
SMILES: C=CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(O)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.

Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID
Eligibility criteria:
Inclusion Criteria:

Cadaveric or Living Donors
18 years old or greater
Primary renal transplants
Hispanic ethnicity

Exclusion Criteria:

Prior renal transplant
Multi-organ transplant
Recipient with history of Diabetes Mellitus
PRA > 20%
Cold Ischemia Time > 24 hours
Intervention: Theophylline
Trial phase: Phase 1
ATC code: R03DA04 | R03DA20 | R03DA54 | R03DA74 | R03DB04
SMILES: Cn1c(=O)c2[nH]cnc2n(C)c1=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: Each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) on Day 1 at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
Eligibility criteria:
Inclusion Criteria:

Healthy adults 18-45 years of age, non-smoking and non-pregnant (postmenopausal, surgically sterile or using effective contraceptive measures) with a body mass index (BMI) greater than or equal to 18 and less than or equal to 32, inclusive

Exclusion Criteria:

Recent participation (within 28 days) in other research studies
Recent significant blood donation or donation of plasma
Pregnant or lactating
Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
Recent (2-year) history or evidence of alcoholism or drug abuse
History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease
Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
Intervention: Desflurane
Trial phase: Not Applicable
ATC code: N01AB07
SMILES: FC(F)OC(F)C(F)(F)F
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 80
Group description: General Anesthesia with Desflurane
Eligibility criteria:
Inclusion Criteria:

Patient ages 18-64
American Society of Anesthesiology Physical Status I, II or III
Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital

Exclusion Criteria:

Open cholecystectomy - excluded due to increased levels of pain in open procedures
Scheduled for ambulatory surgery
Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
Allergy to any of the study medications or anesthetic agents
Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
Patient or surgeon refusal
Intervention: Sevoflurane
Trial phase: Not Applicable
ATC code: N01AB08
SMILES: FCOC(C(F)(F)F)C(F)(F)F
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 80
Group description: General Anesthesia with Sevoflurane
Eligibility criteria:
Inclusion Criteria:

Patient ages 18-64
American Society of Anesthesiology Physical Status I, II or III
Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital

Exclusion Criteria:

Open cholecystectomy - excluded due to increased levels of pain in open procedures
Scheduled for ambulatory surgery
Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
Allergy to any of the study medications or anesthetic agents
Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
Patient or surgeon refusal
Intervention: Isoflurane
Trial phase: Not Applicable
ATC code: N01AB06
SMILES: FC(F)OC(Cl)C(F)(F)F
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 80
Group description: General Anesthesia with Isoflurane
Eligibility criteria:
Inclusion Criteria:

Patient ages 18-64
American Society of Anesthesiology Physical Status I, II or III
Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital

Exclusion Criteria:

Open cholecystectomy - excluded due to increased levels of pain in open procedures
Scheduled for ambulatory surgery
Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
Allergy to any of the study medications or anesthetic agents
Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
Patient or surgeon refusal
Intervention: Propofol
Trial phase: Not Applicable
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 80
Group description: General Anesthesia with Propofol
Eligibility criteria:
Inclusion Criteria:

Patient ages 18-64
American Society of Anesthesiology Physical Status I, II or III
Inpatients scheduled to undergo laparoscopic cholecystectomy at Ben Taub General Hospital

Exclusion Criteria:

Open cholecystectomy - excluded due to increased levels of pain in open procedures
Scheduled for ambulatory surgery
Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
Allergy to any of the study medications or anesthetic agents
Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
Patient or surgeon refusal
Intervention: Colchicine
Trial phase: Phase 1
ATC code: M04AC01
SMILES: COc1cc2c(c(OC)c1OC)-c1ccc(OC)c(=O)cc1[C@@H](NC(C)=O)CC2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
Eligibility criteria:
Inclusion Criteria:

Healthy adults 18-45 years of age, non-smoking and non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures) with a body mass index (BMI) greater than or equal to 18 and less than or equal to 32, inclusive.

Exclusion Criteria:

Recent participation (within 28 days) in other research studies
Recent significant blood donation or plasma donation
Pregnant or lactating
Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
Recent (2-year) history or evidence of alcoholism or drug abuse
History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
Drug allergies to colchicine or cyclosporine
Intervention: Colchicine
Trial phase: Phase 1
ATC code: M04AC01
SMILES: COc1cc2c(c(OC)c1OC)-c1ccc(OC)c(=O)cc1[C@@H](NC(C)=O)CC2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
Eligibility criteria:
Inclusion Criteria:

Healthy adults 18-45 years of age, non-smoking and non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures) with a body mass index (BMI) greater than or equal to 18 and less than or equal to 32, inclusive.

Exclusion Criteria:

Recent participation (within 28 days) in other research studies
Recent significant blood donation or plasma donation
Pregnant or lactating
Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
Recent (2-year) history or evidence of alcoholism or drug abuse
History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
Drug allergies to colchicine
Intervention: Colchicine
Trial phase: Phase 1
ATC code: M04AC01
SMILES: COc1cc2c(c(OC)c1OC)-c1ccc(OC)c(=O)cc1[C@@H](NC(C)=O)CC2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: On the morning of Day 1 after a fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg.
Eligibility criteria:
Inclusion Criteria:

Healthy, non-smoking, adult volunteers, male and female, 18 to 45 years of age, weighing at least 55 kg and within 15% of ideal body weight, with hemoglobin >/=12 g/dL.
Female volunteers must be sexually abstinent for 14 days prior to the first dose and throughout the study or using acceptable birth control methods (prior to and during the study), including being postmenopausal or surgically sterile (or sexual activity restricted to a partner that is surgically sterile), hormonal contraception, an IUD, or barrier methods with spermicide. Additionally, they will be advised to remain sexually inactive or to keep the same birth control method for at least 14 days following the last dose of colchicine.

Exclusion Criteria:

Subjects who are pregnant or lactating
Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg) or hepatitis C virus (HCV)
Have history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease; have used any drugs or substances known to inhibit or induce CYP enzymes and/or P-gp within 30 days prior to the first dose and throughout the study
Recent (2-year) history of evidence of alcoholism or drug abuse
Subjects who donated 50-499 ml of blood within 30 days and more than 499 ml within 56 days prior to the first dose; subjects who have donated in excess of 500 ml of blood in 14 days, 1500 ml or blood in 180 days, or 2500 ml of blood in 1 year (through completion of the study)
Have participated in another clinical trial within 30 days prior to dosing
Known and documented drug allergies to colchicine or macrolide antibiotics.
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: 225
Group description: Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Safety analysis set.
Eligibility criteria:
Inclusion Criteria:

Patients with type 2 diabetes
Patients who are not receiving treatment , or those who currently receive metformin, sitagliptin or vildagliptin or the combination of these
Patients will be screened by a blood test and only those who need additional therapy can be enrolled

Exclusion Criteria:

Patients with type 1 diabetes
Patients with very poorly controlled diabetes
Any clinically significant illness, which in the judgement of the investigator would compromise the patient's safety or successful participation in the clinical study
Intervention: Duloxetine
Trial phase: Phase 4
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 244
Group description: Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Eligibility criteria:
Inclusion Criteria:

Have received treatment with an SSRI (escitalopram, sertraline, paroxetine, or citalopram) for major depressive disorder
Females of child-bearing potential to test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control
Apathy Evaluation Scale - Clinician Rated Version (AES-C) total score >30 at screening and randomization.
Montgomery-Asberg Depression Rating Scale (MADRS) total score ≤15 and Item 1 (apparent sadness) score of <2 at screening and randomization.
Have a level of understanding sufficient to provide informed consent and to communicate with the investigators, study coordinator, and site personnel.

Exclusion Criteria:

Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device
Have previously completed or withdrawn from this study or any other study investigating duloxetine.
Have had previous lack of response to an adequate trial of duloxetine within the past 12 months or escitalopram at any time.
Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), diagnosis of mania, bipolar disorder, treatment resistant depression or psychosis; or current suicide risk
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(DSM-IV-TR),substance abuse or dependence within the 6 months
Presence of an Axis II disorder
Monoamine oxidase inhibitor (MAOI) treatment within 14 days prior to randomization or the potential need to use an MAOI during the study
Positive urine drug screen for any substance of abuse or excluded medication.
Are pregnant or breast-feeding.
Serious medical illness, requires hospitalization during the study
Have uncontrolled narrow-angle glaucoma.
Have acute liver injury or severe cirrhosis
Abnormal thyroid stimulating hormone (TSH) concentration
Amphetamines, dopaminergic medications or modafinil within 14 days prior to randomization or potential need to use such medications during the study or within 14 days of discontinuation of study drug.