anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ecabet
Trial phase: Phase 2
SMILES: [H][C@@]12CCc3cc(C(C)C)c(S(=O)(=O)O)cc3[C@@]1(C)CCC[C@@]2(C)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 95
Group description: ecabet ophthalmic solution

ecabet ophthalmic solution: sterile ophthalmic solution
Eligibility criteria:
Inclusion Criteria:

Diagnosed with dry eye disease

Exclusion Criteria:

Dry eye disease secondary to surgery
Intervention: Paricalcitol
Trial phase: Phase 2
ATC code: H05BX02
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1C[C@@H](O)C[C@H](O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Paricalcitol initial dosage 2 µg with incremental adjustment of 1 µg
Eligibility criteria:
Inclusion Criteria:

Diagnosed with chronic kidney disease receiving hemodialysis 3 times a week for at least 3 months prior to obtaining the informed consent and scheduled to be receiving the same hemodialysis during the study period.
Using dialysate with constant concentration of calcium for 4 weeks prior to obtaining informed consent and phosphate binder with constant dose regimen for 2 weeks prior to obtaining informed consent.
Intact parathyroid hormone level (iPTH) ≥ 300 pg/mL
Calcium (adjusted) 8.4-10.2 milligrams/deciliter (mg/dL)
Phosphorus ≤ 6.5 mg/dL
Age ≥ 20 years

Exclusion Criteria:

History of allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds
Parathyroidectomy or ethanol infusion within past year
Progressive malignancy or clinically significant hepatic diseases, severe cerebral/cardiovascular diseases, severe hypertension, or uncontrolled diabetes mellitus
Drug or alcohol abuse within past 6 months
Taking calcitonin, maintenance intravenous or oral glucocorticoids, cinacalcet, bisphosphonates, selective estrogen-receptor modulator (SERM), vitamin D compounds (other than study drug), or other drugs that may affect calcium or bone metabolism (other than estrogen or progestin, vitamin K2)
Will need to take chronic dose (≥ 2 consecutive weeks) of cytochrome P450 (CYP3A) inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin)
Taking aluminum containing products (2 weeks prior to consent)
Intervention: Paricalcitol
Trial phase: Phase 2
ATC code: H05BX02
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1C[C@@H](O)C[C@H](O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Paricalcitol initial dosage 4 µg with incremental adjustment of 1 µg
Eligibility criteria:
Inclusion Criteria:

Diagnosed with chronic kidney disease receiving hemodialysis 3 times a week for at least 3 months prior to obtaining the informed consent and scheduled to be receiving the same hemodialysis during the study period.
Using dialysate with constant concentration of calcium for 4 weeks prior to obtaining informed consent and phosphate binder with constant dose regimen for 2 weeks prior to obtaining informed consent.
Intact parathyroid hormone level (iPTH) ≥ 300 pg/mL
Calcium (adjusted) 8.4-10.2 milligrams/deciliter (mg/dL)
Phosphorus ≤ 6.5 mg/dL
Age ≥ 20 years

Exclusion Criteria:

History of allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds
Parathyroidectomy or ethanol infusion within past year
Progressive malignancy or clinically significant hepatic diseases, severe cerebral/cardiovascular diseases, severe hypertension, or uncontrolled diabetes mellitus
Drug or alcohol abuse within past 6 months
Taking calcitonin, maintenance intravenous or oral glucocorticoids, cinacalcet, bisphosphonates, selective estrogen-receptor modulator (SERM), vitamin D compounds (other than study drug), or other drugs that may affect calcium or bone metabolism (other than estrogen or progestin, vitamin K2)
Will need to take chronic dose (≥ 2 consecutive weeks) of cytochrome P450 (CYP3A) inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin)
Taking aluminum containing products (2 weeks prior to consent)
Intervention: Paricalcitol
Trial phase: Phase 2
ATC code: H05BX02
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1C[C@@H](O)C[C@H](O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Paricalcitol initial dosage 4 µg with incremental adjustment of 2 µg
Eligibility criteria:
Inclusion Criteria:

Diagnosed with chronic kidney disease receiving hemodialysis 3 times a week for at least 3 months prior to obtaining the informed consent and scheduled to be receiving the same hemodialysis during the study period.
Using dialysate with constant concentration of calcium for 4 weeks prior to obtaining informed consent and phosphate binder with constant dose regimen for 2 weeks prior to obtaining informed consent.
Intact parathyroid hormone level (iPTH) ≥ 300 pg/mL
Calcium (adjusted) 8.4-10.2 milligrams/deciliter (mg/dL)
Phosphorus ≤ 6.5 mg/dL
Age ≥ 20 years

Exclusion Criteria:

History of allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds
Parathyroidectomy or ethanol infusion within past year
Progressive malignancy or clinically significant hepatic diseases, severe cerebral/cardiovascular diseases, severe hypertension, or uncontrolled diabetes mellitus
Drug or alcohol abuse within past 6 months
Taking calcitonin, maintenance intravenous or oral glucocorticoids, cinacalcet, bisphosphonates, selective estrogen-receptor modulator (SERM), vitamin D compounds (other than study drug), or other drugs that may affect calcium or bone metabolism (other than estrogen or progestin, vitamin K2)
Will need to take chronic dose (≥ 2 consecutive weeks) of cytochrome P450 (CYP3A) inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin)
Taking aluminum containing products (2 weeks prior to consent)
Intervention: Maxacalcitol
Trial phase: Phase 2
SMILES: [H]C(=C1\C[C@@]([H])(O)C[C@]([H])(O)C1=C)/C([H])=C1\CCC[C@]2(C)[C@@]([H])([C@]([H])(C)OCCC(C)(C)O)CC[C@@]12[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Maxacalcitol initial dosage 5 or 10 µg with incremental adjustment of 2.5 µg
Eligibility criteria:
Inclusion Criteria:

Diagnosed with chronic kidney disease receiving hemodialysis 3 times a week for at least 3 months prior to obtaining the informed consent and scheduled to be receiving the same hemodialysis during the study period.
Using dialysate with constant concentration of calcium for 4 weeks prior to obtaining informed consent and phosphate binder with constant dose regimen for 2 weeks prior to obtaining informed consent.
Intact parathyroid hormone level (iPTH) ≥ 300 pg/mL
Calcium (adjusted) 8.4-10.2 milligrams/deciliter (mg/dL)
Phosphorus ≤ 6.5 mg/dL
Age ≥ 20 years

Exclusion Criteria:

History of allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds
Parathyroidectomy or ethanol infusion within past year
Progressive malignancy or clinically significant hepatic diseases, severe cerebral/cardiovascular diseases, severe hypertension, or uncontrolled diabetes mellitus
Drug or alcohol abuse within past 6 months
Taking calcitonin, maintenance intravenous or oral glucocorticoids, cinacalcet, bisphosphonates, selective estrogen-receptor modulator (SERM), vitamin D compounds (other than study drug), or other drugs that may affect calcium or bone metabolism (other than estrogen or progestin, vitamin K2)
Will need to take chronic dose (≥ 2 consecutive weeks) of cytochrome P450 (CYP3A) inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin)
Taking aluminum containing products (2 weeks prior to consent)
Intervention: Fluocinonide
Trial phase: Phase 2
ATC code: C05AA11 | D07AC08 | D07CC05
SMILES: [H][C@@]12C[C@@]3([H])OC(C)(C)O[C@@]3(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: fluocinonide 0.05% cream applied twice per day to affected areas
Eligibility criteria:
Inclusion Criteria:

Patients receiving sorafenib as monotherapy or in combination if other agents are not known to cause HFSR.
Subjects must be 18 years or older.
Patients must provide written informed consent to participate in the study.
Women of childbearing potential and men must be willing to use an effective method of contraception while participating in this study and for at least two weeks after completing treatment in the study.
Women in this study need to have a negative urine pregnancy test before starting study medications.

Exclusion Criteria:

Patients simultaneously taking another anti-cancer agent or combination of anti-cancer agents known to cause hand foot syndrome (pegylated doxorubicin, 5-fluorouracil, cytarabine).
Patients with an active dermatological condition due to previous chemotherapy or biologic therapy affecting the hands.
Patients with pre-existing dermatological condition affecting the hands or feet.
Women who have a positive pregnancy test or are lactating.
Intervention: Tazarotene
Trial phase: Phase 2
ATC code: D05AX05 | D05AX55
SMILES: CCOC(=O)c1ccc(C#Cc2ccc3c(c2)C(C)(C)CCS3)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: tazarotene 0.1% cream applied twice per day to affected areas
Eligibility criteria:
Inclusion Criteria:

Patients receiving sorafenib as monotherapy or in combination if other agents are not known to cause HFSR.
Subjects must be 18 years or older.
Patients must provide written informed consent to participate in the study.
Women of childbearing potential and men must be willing to use an effective method of contraception while participating in this study and for at least two weeks after completing treatment in the study.
Women in this study need to have a negative urine pregnancy test before starting study medications.

Exclusion Criteria:

Patients simultaneously taking another anti-cancer agent or combination of anti-cancer agents known to cause hand foot syndrome (pegylated doxorubicin, 5-fluorouracil, cytarabine).
Patients with an active dermatological condition due to previous chemotherapy or biologic therapy affecting the hands.
Patients with pre-existing dermatological condition affecting the hands or feet.
Women who have a positive pregnancy test or are lactating.
Intervention: Urea
Trial phase: Phase 2
ATC code: B05BC02 | D02AE01 | D02AE51
SMILES: NC(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: urea 40% cream applied twice per day to affected areas
Eligibility criteria:
Inclusion Criteria:

Patients receiving sorafenib as monotherapy or in combination if other agents are not known to cause HFSR.
Subjects must be 18 years or older.
Patients must provide written informed consent to participate in the study.
Women of childbearing potential and men must be willing to use an effective method of contraception while participating in this study and for at least two weeks after completing treatment in the study.
Women in this study need to have a negative urine pregnancy test before starting study medications.

Exclusion Criteria:

Patients simultaneously taking another anti-cancer agent or combination of anti-cancer agents known to cause hand foot syndrome (pegylated doxorubicin, 5-fluorouracil, cytarabine).
Patients with an active dermatological condition due to previous chemotherapy or biologic therapy affecting the hands.
Patients with pre-existing dermatological condition affecting the hands or feet.
Women who have a positive pregnancy test or are lactating.
Intervention: Prednisone
Trial phase: Phase 2
ATC code: A07EA03 | H02AB07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 181
Group description: Participants will receive a 15-day tapering course of prednisone capsules.

Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days.
Eligibility criteria:
Inclusion Criteria:

Seeks care at a Kaiser Permanente clinic spine care specialist at the San Jose, Redwood City, or Roseville site
Complains of low back pain and functionally incapacitating leg pain extending below the knee with a nerve root distribution
Score of at least 20 on the modified Oswestry Disability Index
Appears, in the opinion of the study physician, to be very likely to have a herniated lumbar disc
MRI study confirms a herniated disc consistent with the signs and symptoms

Exclusion Criteria:

Onset of sciatica symptoms occurred more than 3 months before study entry
Cauda equina syndrome
Active cancer
Acute spinal fracture
Currently taking oral steroids
Diabetes mellitus and taking insulin or glycohemoglobin greater than 10%
Systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110 mm Hg
Pregnant or breastfeeding
Active peptic ulcer disease
History of intolerance to steroid therapy
Bleeding diathesis or anticoagulant therapy
Ongoing litigation or workers compensation claim for low back pain or sciatica
Underwent previous lumbar surgery
Received epidural steroid injection (ESI) within the 12 months before study entry
Unable to read or speak English
Progressive or severe motor loss
Intervention: Citalopram
Trial phase: Phase 3
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 322
Group description: Escitalopram low dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
Eligibility criteria:
Inclusion Criteria:

Patients must meet Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder.
The patient's current depressive episode must be at least 8 weeks in duration.

Exclusion Criteria:

Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control.
Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.
Patients who are considered a suicide risk
Patients with a history of seizures (including seizure disorder), stroke, significant head injury, central nervous system tumors, or any other condition that predisposes patients to a risk for seizure.
Intervention: Citalopram
Trial phase: Phase 3
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 324
Group description: Escitalopram high dose, administered orally (QD [once a day]) for 8 weeks of stable dose treatment phase. The Overall Number of Baseline Participants is based on the Safety population.
Eligibility criteria:
Inclusion Criteria:

Patients must meet Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder.
The patient's current depressive episode must be at least 8 weeks in duration.

Exclusion Criteria:

Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control.
Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.
Patients who are considered a suicide risk
Patients with a history of seizures (including seizure disorder), stroke, significant head injury, central nervous system tumors, or any other condition that predisposes patients to a risk for seizure.
Intervention: Dutasteride
Trial phase: Phase 2
ATC code: G04CA52 | G04CB02
SMILES: [H][C@@]12CC[C@@]3([H])NC(=O)C=C[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1([H])C(=O)Nc1cc(C(F)(F)F)ccc1C(F)(F)F
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Arm A patients received dutasteride (0.5 mg/day) during the first off-cycle and received placebo during the second off-cycle

Dutasteride: 0.5 mg capsule given orally on daily basis
Eligibility criteria:
Inclusion Criteria:

Histologically proven prostate cancer
Patients are hormone-naive
Patients either to begin androgen ablation therapy with luteinizing hormone-releasing hormone (LHRH) agonist or already receiving therapy with LHRH agonist
Advanced prostate cancer with either positive pelvic nodes or bone/visceral metastasis
Must have an intact prostate (no previous surgery or XRT)
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Recovery from any major infection or surgical procedure
Signed informed consent

Exclusion Criteria:

Known intolerance or allergy to dutasteride
Concomitant chemotherapy, biologic therapy, or XRT to prostate
Bilateral orchiectomy
Prior malignancy within 5 years of registration
Intervention: Minocycline
Trial phase: Phase 4
ATC code: A01AB23 | D10AF07 | J01AA08 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)ccc(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: A single unit dose of 1mg minocycline HCl (with approximately 3mg PGLA) professionally administered subgingivally into periodontal pockets at each site exhibiting a PD ≥ 5mm
Eligibility criteria:
Inclusion Criteria:

generally healthy
over 25 years of age
moderate-to-severe chronic periodontitis
documented informed consent
willing to comply with contraceptive requirements
free from any significant oral soft tissue pathology

Exclusion Criteria:

willing to adhere to prohibitions and restrictions of the study
oral health inappropriate for study inclusion
females self-reporting pregnancy or lactation, or having a positive urine pregnancy result

reporting any of the following conditions:

allergy to a tetracycline-class drug
systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures
active systemic infectious disease such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis
diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement
participation in a dental clinical trial or use of an investigational drug within 30 days of enrollment
employees of the Investigator or study center, with direct involvement in the proposed study or other studies, as well as family members of the employees or the Investigator
anyone who the investigator determines should not be included in the study for any reason that could compromise safety or the analysis of study results
Intervention: Pantoprazole
Trial phase: Not Applicable
ATC code: A02BC02 | A02BD04 | A02BD11
SMILES: COc1ccnc(CS(=O)c2nc3ccc(OC(F)F)cc3[nH]2)c1OC
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: CYP2C19 enzyme activity in extensive metabolizers of CYP2C19 (CYP2C19*1/*1 genotype, or wild type) was measured by 13C)Pantoprazole breath test.

[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes
Eligibility criteria:
Inclusion Criteria:

Asian male or female subjects between 18 and 49 years of age, who are in good physical health with no significant medical problems or laboratory test abnormalities. Subjects should have normal liver and kidney function.
Subjects with BMI <30 which will be determined by Metropolitan height and weight tables. Subjects must weigh at least 110 pounds.
Subjects must agree to refrain from taking any prescription and over-the-counter medications, as well as any herbal medications one week before the start of the study and during the study period.
Subjects must agree to refrain from consuming alcohol 48 hours before the start of the study and during the study period.
Subjects must be capable of satisfying protocol requirements and be able to sign written informed consent.

Exclusion Criteria:

Subjects who have a history of intolerance or allergy to the study drug: pantoprazole.
Subjects who have donated blood within the last 60 days of the screening visit or plan to donate blood during the course of the study or within 60 days after study completion.
Subjects who have had treatment with any investigational drug within the past 30 days.
Subjects who have used illegal drugs within three months prior to enrollment.
Female subjects currently taking oral contraceptive birth control pills and who are unwilling or unable to stop oral contraceptives and use a barrier contraceptive method (such as condom, contraceptive foams, etc.) starting from the time of screening phase to the completion of the study.
Female subjects who are pregnant or lactating.
Subjects who are unreliable in the opinion of the study physician.
Intervention: Pantoprazole
Trial phase: Not Applicable
ATC code: A02BC02 | A02BD04 | A02BD11
SMILES: COc1ccnc(CS(=O)c2nc3ccc(OC(F)F)cc3[nH]2)c1OC
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: CYP2C19 activity in heterozygous for deficient CYP2C19 alleles (*2 and *3, IM of CYP2C19) was measured by (13C)Pantoprazole breath test.

[13C]Pantoprazole: [13C]Pantoprazole was administered to EM, IM and PM of CYP2C19 and enzyme activity was measured through breath test and compared among the genotypes
Eligibility criteria:
Inclusion Criteria:

Asian male or female subjects between 18 and 49 years of age, who are in good physical health with no significant medical problems or laboratory test abnormalities. Subjects should have normal liver and kidney function.
Subjects with BMI <30 which will be determined by Metropolitan height and weight tables. Subjects must weigh at least 110 pounds.
Subjects must agree to refrain from taking any prescription and over-the-counter medications, as well as any herbal medications one week before the start of the study and during the study period.
Subjects must agree to refrain from consuming alcohol 48 hours before the start of the study and during the study period.
Subjects must be capable of satisfying protocol requirements and be able to sign written informed consent.

Exclusion Criteria:

Subjects who have a history of intolerance or allergy to the study drug: pantoprazole.
Subjects who have donated blood within the last 60 days of the screening visit or plan to donate blood during the course of the study or within 60 days after study completion.
Subjects who have had treatment with any investigational drug within the past 30 days.
Subjects who have used illegal drugs within three months prior to enrollment.
Female subjects currently taking oral contraceptive birth control pills and who are unwilling or unable to stop oral contraceptives and use a barrier contraceptive method (such as condom, contraceptive foams, etc.) starting from the time of screening phase to the completion of the study.
Female subjects who are pregnant or lactating.
Subjects who are unreliable in the opinion of the study physician.