anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lasmiditan
Trial phase: Phase 2
ATC code: N02CC08
SMILES: CN1CCC(C(=O)c2cccc(NC(=O)c3c(F)cc(F)cc3F)n2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 82
Group description: 50 mg lasmiditan administered orally (PO)
Eligibility criteria:
Inclusion Criteria:

Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (2004)
History of migraine of at least 1 year
Migraine onset before the age of 50 years
History of 1 - 8 migraine attacks per month
Male or female patients aged 18 to 65 years
Female patients of child-bearing potential must be using a highly effective form of contraception (e.g., combined oral contraceptive, IUD, abstinence, vasectomized partner)
Able and willing to give written informed consent
Able and willing to complete a migraine diary card to record details of the attack treated with study medication

Exclusion Criteria:

History of life threatening or intolerable adverse reaction to any triptan
Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation
Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis
Using 5-HT reuptake inhibitors
Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)
Pregnant or breast-feeding women
Women of child-bearing potential not using highly effective contraception
History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures
History of hypertension (controlled or uncontrolled)
History of orthostatic hypotension
Current use of hemodynamically active cardiovascular drugs
History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol
Significant renal or hepatic impairment
Previous participation in this clinical trial
Participation in any clinical trial of an experimental drug or device in the previous 30 days
Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study
Known Hepatitis B or C or HIV infection
Patients who are employees of the sponsor
Relatives of, or staff directly reporting to, the investigator
Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144 drug product
Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded)
Intervention: Lasmiditan
Trial phase: Phase 2
ATC code: N02CC08
SMILES: CN1CCC(C(=O)c2cccc(NC(=O)c3c(F)cc(F)cc3F)n2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 82
Group description: 100 mg lasmiditan administered orally (PO)
Eligibility criteria:
Inclusion Criteria:

Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (2004)
History of migraine of at least 1 year
Migraine onset before the age of 50 years
History of 1 - 8 migraine attacks per month
Male or female patients aged 18 to 65 years
Female patients of child-bearing potential must be using a highly effective form of contraception (e.g., combined oral contraceptive, IUD, abstinence, vasectomized partner)
Able and willing to give written informed consent
Able and willing to complete a migraine diary card to record details of the attack treated with study medication

Exclusion Criteria:

History of life threatening or intolerable adverse reaction to any triptan
Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation
Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis
Using 5-HT reuptake inhibitors
Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)
Pregnant or breast-feeding women
Women of child-bearing potential not using highly effective contraception
History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures
History of hypertension (controlled or uncontrolled)
History of orthostatic hypotension
Current use of hemodynamically active cardiovascular drugs
History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol
Significant renal or hepatic impairment
Previous participation in this clinical trial
Participation in any clinical trial of an experimental drug or device in the previous 30 days
Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study
Known Hepatitis B or C or HIV infection
Patients who are employees of the sponsor
Relatives of, or staff directly reporting to, the investigator
Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144 drug product
Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded)
Intervention: Lasmiditan
Trial phase: Phase 2
ATC code: N02CC08
SMILES: CN1CCC(C(=O)c2cccc(NC(=O)c3c(F)cc(F)cc3F)n2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 71
Group description: 200 mg lasmiditan administered orally (PO)
Eligibility criteria:
Inclusion Criteria:

Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (2004)
History of migraine of at least 1 year
Migraine onset before the age of 50 years
History of 1 - 8 migraine attacks per month
Male or female patients aged 18 to 65 years
Female patients of child-bearing potential must be using a highly effective form of contraception (e.g., combined oral contraceptive, IUD, abstinence, vasectomized partner)
Able and willing to give written informed consent
Able and willing to complete a migraine diary card to record details of the attack treated with study medication

Exclusion Criteria:

History of life threatening or intolerable adverse reaction to any triptan
Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation
Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis
Using 5-HT reuptake inhibitors
Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)
Pregnant or breast-feeding women
Women of child-bearing potential not using highly effective contraception
History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures
History of hypertension (controlled or uncontrolled)
History of orthostatic hypotension
Current use of hemodynamically active cardiovascular drugs
History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol
Significant renal or hepatic impairment
Previous participation in this clinical trial
Participation in any clinical trial of an experimental drug or device in the previous 30 days
Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study
Known Hepatitis B or C or HIV infection
Patients who are employees of the sponsor
Relatives of, or staff directly reporting to, the investigator
Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144 drug product
Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded)
Intervention: Lasmiditan
Trial phase: Phase 2
ATC code: N02CC08
SMILES: CN1CCC(C(=O)c2cccc(NC(=O)c3c(F)cc(F)cc3F)n2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: 400 mg lasmiditan administered orally (PO)
Eligibility criteria:
Inclusion Criteria:

Patients with migraine with or without aura fulfilling the IHS diagnostic criteria 1.1 and 1.2.1 (2004)
History of migraine of at least 1 year
Migraine onset before the age of 50 years
History of 1 - 8 migraine attacks per month
Male or female patients aged 18 to 65 years
Female patients of child-bearing potential must be using a highly effective form of contraception (e.g., combined oral contraceptive, IUD, abstinence, vasectomized partner)
Able and willing to give written informed consent
Able and willing to complete a migraine diary card to record details of the attack treated with study medication

Exclusion Criteria:

History of life threatening or intolerable adverse reaction to any triptan
Use of prescription migraine prophylactic drugs within 15 days (30 days for flunarizine) prior to Screening Visit and during study participation
Using herbal preparations (e.g., feverfew, butterbur) for migraine prophylaxis
Using 5-HT reuptake inhibitors
Using drugs known to inhibit CYP450 enzymes (see Appendix 2 for details)
Pregnant or breast-feeding women
Women of child-bearing potential not using highly effective contraception
History or evidence of coronary artery disease, ischemic or hemorrhagic stroke, epilepsy or any other condition placing the patient at increased risk of seizures
History of hypertension (controlled or uncontrolled)
History of orthostatic hypotension
Current use of hemodynamically active cardiovascular drugs
History within the previous 3 years or current evidence of abuse of any drug, prescription or illicit, or alcohol
Significant renal or hepatic impairment
Previous participation in this clinical trial
Participation in any clinical trial of an experimental drug or device in the previous 30 days
Any medical condition or laboratory test which in the judgment of the investigator makes the patient unsuitable for the study
Known Hepatitis B or C or HIV infection
Patients who are employees of the sponsor
Relatives of, or staff directly reporting to, the investigator
Patients with known hypersensitivity to COL-144, other 5HT1F receptor agonists or to any excipient of COL-144 drug product
Patients who were treated with study medication in the COL MIG-201 study (Patients screened but not treated under that protocol are not excluded)
Intervention: Ethanol
Trial phase: Phase 3
ATC code: D08AX08 | V03AB16 | V03AZ01
SMILES: CCO
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
Eligibility criteria:
Inclusion Criteria:

Male or female Subjects of any race, aged 12 to 35 years inclusive
Subjects with mild or moderate facial acne vulgaris
Subjects with skin phototype I to IV

Exclusion Criteria:

Subjects with more than 1 nodules or cysts on the face,
Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)
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: No
Participants at risk: 112
Group description: Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
Eligibility criteria:
Inclusion Criteria:

Subjects must meet diagnostic criteria for fibromyalgia;
Subjects must report difficulty in maintaining sleep at least 3 times per week and meet Research Diagnostic Criteria (RDC) for insomnia disorder, corroborated by subject diary, and meet PSG inclusion criteria at visit 3.

Exclusion Criteria:

History of active sleep disorder other than Research Diagnostic Criteria(RDC) insomnia criteria or any sleep or circadian rhythm disturbance;
Use of medications known to affect sleep wake function by Visit 2;
Involved in night or rotating shift work, or travel across >4 time zones 14 days prior to screening and during study; regular daytime napping
PSG finding of apnea/hypopnea or periodic limb movement with arousal index >10/hr on either night of PSG.
Intervention: Cyclosporine
Trial phase: Phase 3
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: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 171
Group description: Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
Eligibility criteria:
Inclusion Criteria:

Have a clinical diagnosis of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye)
Be on stable doses of your current AKC medications for at least 2 weeks

Exclusion Criteria:

You have used contact lenses within 48 hours of Day 1 or think you may have to wear contact lenses during the study
You are pregnant, breastfeeding, or planning to become pregnant during the study
You have used a calcineurin inhibitors (e.g. topical tacrolimus or topical pimecrolimus) on or around your eyes including eyelids within 4 weeks
Intervention: Odanacatib
Trial phase: Phase 2
SMILES: CC(C)(F)C[C@H](N[C@@H](c1ccc(-c2ccc(S(C)(=O)=O)cc2)cc1)C(F)(F)F)C(=O)NC1(C#N)CC1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 122
Group description: Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
Eligibility criteria:
Inclusion Criteria:

Has been postmenopausal for at least 5 years
Has taken or is taking alendronate
Agrees not to use medications for osteoporosis other than what is provided by the study

Exclusion Criteria:

Has a history or evidence of hip fracture
Has a history of cancer within 5 years of screening, except certain skin or cervical cancers.
Has active parathyroid disease
Has a history of thyroid disease not adequately controlled by medication
Is taking anti-seizure medication and has abnormal calcium metabolism
Has received any bisphosphonate other than alendronate for 20% of the last 3 years, or within 3 months of screening
Intervention: Gabapentin
Trial phase: Not Applicable
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Placebo Elixir (300 mg x 6 doses)

Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Placebo 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
Eligibility criteria:
Inclusion Criteria:

Patients undergoing laparoscopic gastric bypass surgery
Age > 18 years

Exclusion Criteria:

Patients under the age of 18 years
Patients who undergo open gastric bypass
Patients with a history of chronic pain treated with pregabalin, gabapentin or opioids
Patients with a history of chronic renal disease (creatinine > 1.3)
Patients with a history of bleeding gastric ulcer
Intervention: Gabapentin
Trial phase: Not Applicable
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: Preoperative Gabapentin Elixir (1200 mg) AND Postoperative Gabapentin Elixir (300 mg x 6 doses)

Gabapentin: Gabapentin 1200 mg (24 cc) by mouth 1 hour prior to surgery AND Gabapentin 300 mg (6cc) by mouth x 6 doses after surgery (0800PM the evening of surgery, 0800AM postoperative day 1, 0200PM postoperative day 1, 0800PM postoperative day 1, 0800AM postoperative day 2, 1200PM postoperative day 2)
Eligibility criteria:
Inclusion Criteria:

Patients undergoing laparoscopic gastric bypass surgery
Age > 18 years

Exclusion Criteria:

Patients under the age of 18 years
Patients who undergo open gastric bypass
Patients with a history of chronic pain treated with pregabalin, gabapentin or opioids
Patients with a history of chronic renal disease (creatinine > 1.3)
Patients with a history of bleeding gastric ulcer
Intervention: Pituitrin
Trial phase: Not Applicable
SMILES: NC(=O)CCC1NC(=O)C(Cc2ccccc2)NC(=O)C(Cc2ccc(O)cc2)NC(=O)C(N)CSSCC(C(=O)N2CCCC2C(=O)NC(CCCN=C(N)N)C(=O)NCC(N)=O)NC(=O)C(CC(N)=O)NC1=O.NCCCCC(NC(=O)C1CCCN1C(=O)C1CSSCC(N)C(=O)NC(Cc2ccc(O)cc2)C(=O)NC(Cc2ccccc2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: Vasopressin: Patients randomly assigned to the experimental arm of the study will receive vasopressin 0.5U/hr IV (20 U vasopressin in 250mL of 0.9% NaCL to infuse at a rate of 6.25mL/hr) via internal jugular catheter. Vasopressin infusion is started at the time of incision and is stopped at the time abdominal closure is completed
Eligibility criteria:
Inclusion Criteria:

> 18 years of age
undergoing liver transplant
ability to provide informed consent. If patient is unable to give informed consent i.e. hepatic encephalopathy, consent may be obtained from the patient's legally authorized representative

Exclusion Criteria:

< 18 years of age
renal failure
Intervention: EXENATIDE
Trial phase: Phase 2
ATC code: A10BJ01
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(N)=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Exenatide 5 mcg for 1-month then uptitration to 10-mcg for remaining 2-months.
Eligibility criteria:
Inclusion Criteria:

Age 8-19 years old
Subject able to give assent, and parent/guardian capable of giving consent on behalf of the child
Body mass index (BMI) ≥ 99th percentile (based on gender and age)

Exclusion Criteria:

Type 1 or 2 diabetes mellitus
Initiation of a new drug therapy within the past 30 days prior to the screening visit
BMI ≥ 55
History of weight loss surgery
Obesity from a genetic cause (e.g., Prader-Willi)
Central nervous system injury or severe neurological impairment
Known systolic or diastolic dysfunction or heart failure
Females who are currently pregnant or planning to become pregnant
Liver enzymes > 2.5 times upper limit of normal
Severe renal impairment (defined as creatinine clearance <30 mL/min)
Gastrointestinal disease
Intervention: Itraconazole
Trial phase: Phase 2
ATC code: J02AC02
SMILES: CCC(C)n1ncn(-c2ccc(N3CCN(c4ccc(OCC5COC(Cn6cncn6)(c6ccc(Cl)cc6Cl)O5)cc4)CC3)cc2)c1=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)

Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically confirmed prostate adenocarcinoma.
Presence of distant metastases on bone scan, CT scan, or MRI scan.
Progression after androgen deprivation (and anti-androgen withdrawal).
Rising serum PSA (Prostate Cancer Working Group (PCWG2) definition).
Castrate levels of serum testosterone (i.e., ≤ 50 ng/dL).
Age > 18 years.
ECOG performance status score ≤ 2, and/or Karnofsky score ≥ 50%.
Life expectancy > 6 months.
Adequate kidney, liver, and bone marrow function.
Willingness to sign informed consent and adhere to study requirements.

Exclusion Criteria:

Recent surgery, radiation therapy, combined androgen blockade, or investigational therapies in the last 8 weeks.
Previous chemotherapy for metastatic prostate cancer.
Concomitant use of second-line hormonal agents (e.g., ketoconazole, DES)
Current use of corticosteroids, except if on a stable dose for ≥ 3 months.
History of malabsorption syndrome (may affect itraconazole absorption).
Allergic reactions to itraconazole or similar compounds.
Concurrent use of drugs that interact with the CYP3A4 system (caution only).
Presence of known brain metastases.
Prior malignancy in the last 3 years, with some exceptions.
Uncontrolled major infectious, cardiac, or pulmonary illnesses.
Prolonged corrected QT interval (> 450 msec) on electrocardiography.
Intervention: Itraconazole
Trial phase: Phase 2
ATC code: J02AC02
SMILES: CCC(C)n1ncn(-c2ccc(N3CCN(c4ccc(OCC5COC(Cn6cncn6)(c6ccc(Cl)cc6Cl)O5)cc4)CC3)cc2)c1=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)

Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically confirmed prostate adenocarcinoma.
Presence of distant metastases on bone scan, CT scan, or MRI scan.
Progression after androgen deprivation (and anti-androgen withdrawal).
Rising serum PSA (Prostate Cancer Working Group (PCWG2) definition).
Castrate levels of serum testosterone (i.e., ≤ 50 ng/dL).
Age > 18 years.
ECOG performance status score ≤ 2, and/or Karnofsky score ≥ 50%.
Life expectancy > 6 months.
Adequate kidney, liver, and bone marrow function.
Willingness to sign informed consent and adhere to study requirements.

Exclusion Criteria:

Recent surgery, radiation therapy, combined androgen blockade, or investigational therapies in the last 8 weeks.
Previous chemotherapy for metastatic prostate cancer.
Concomitant use of second-line hormonal agents (e.g., ketoconazole, DES)
Current use of corticosteroids, except if on a stable dose for ≥ 3 months.
History of malabsorption syndrome (may affect itraconazole absorption).
Allergic reactions to itraconazole or similar compounds.
Concurrent use of drugs that interact with the CYP3A4 system (caution only).
Presence of known brain metastases.
Prior malignancy in the last 3 years, with some exceptions.
Uncontrolled major infectious, cardiac, or pulmonary illnesses.
Prolonged corrected QT interval (> 450 msec) on electrocardiography.