anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tegafur
Trial phase: Phase 2
ATC code: L01BC03 | L01BC53
SMILES: O=c1[nH]c(=O)n(C2CCCO2)cc1F
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 65
Group description: S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.

S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course.
Eligibility criteria:
Inclusion Criteria:

Biopsy-diagnosed breast cancer with metastasis in multiple organs
Performance Status (World Health Organization :WHO) 0-2

Functions below are maintained in major organs:

Leukocyte count: 4,000/mm3 to 12,000/mm3
Neutrophil count: >2,000/mm3 or more
Platelet count: <100,000/mm3 or more
Hemoglobin: >9.5 g/dL
Total bilirubin: >1.5 mg/dL
AST(GOT): within twice a normal upper value in an institution
AST(GPT): within twice a normal upper value in an institution
BUN: < 25 mg/dL
Creatinine: within a normal upper value in the institution
24 hours creatinine clearance: >50 mL/min (using the Cockcroft-Gault formula)
Women's Ccr = Body weight x (140-Age)/(72 x Serum creatinine) x 0.85
Written informed consent will be obtained for patients for entering this study

Exclusion Criteria:

Patients with synchronous multiple cancers
Complicated with infection
Fever from suspected infection
Metastasis to the central nerve system
A history of ischemic cardiac diseases
Active gastrointestinal ulcer
Severe nerve disorder
Women who are potentially pregnant, pregnant, or breast-feeding
Severe drug allergy
Severe suppression of the bone marrow
Severe renal disorder
Being treated with other pyrimidine fluoride antineoplastic agents (including any combination therapy)
Being treated with flucytosine
Complicated with the infection onset which a study doctor assesses to be inappropriate for this study
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: Adult | Older Adult
Participants at risk: 160
Group description: Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
Eligibility criteria:
Inclusion criteria:

Outpatients 18 years of age and older (max 65 years)
Patients with chronic plaque psoriasis on disease remission (i.e. PASI ≤75% of PASI before cyclosporine continuous treatment course) entering a maintenance period
Disease remission obtained with only cyclosporine as systemic therapy (maximum dose 5 mg/kg/day) for >8 weeks and <16 weeks
PASI still <75% of PASI before cyclosporine continuous treatment course, at randomization to study treatment (8±2 days after disease remission)

Exclusion criteria:

Abnormal renal function (creatinine ≥ 10% the upper limit of the reference range)
Severe chronic degenerative diseases
Severe uncontrolled hypertension
Body weigh >110 kg
Abnormal liver function
Hyperkalemia or hyperuricemia
Clinically significant impairment of hematopoietic and cardiovascular function
Concomitant therapy with nephrotoxic medications
Patients with malignancy or a history of malignancy
Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception
Clinically significant uncontrolled bacterial, viral or fungal infection
Evidence of drug and/or alcohol abuse
Intervention: HYDROXYPROGESTERONE CAPROATE
Trial phase: Phase 3
ATC code: G03DA03
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(=O)CCCCC)C(C)=O
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 327
Group description: 250 mg of 17 alpha-hydroxyprogesterone caproate given by weekly injection until 37 weeks gestation or delivery

17 alpha-hydroxyprogesterone caproate: Coded study medication is sterile solution containing 250 mg/mL of 17 alpha-hydroxyprogesterone caproate in castor oil with benzyl benzoate and benzyl alcohol as a preservative; placebo is same without the active ingredient. Study drug is administered as weekly 1 ml intramuscular injections until 36 week 6 days of gestation or delivery, whichever occurs first.
Eligibility criteria:
Inclusion Criteria:

Nulliparous
Cervical length as measured on transvaginal examination < 30mm between gestational ages of 16 weeks 0 days to 22 weeks 3 days
Gestational age 16 weeks 3 days to 22 weeks 6 days at time of randomization

Exclusion Criteria:

Multifetal gestation
Progesterone treatment after 14 weeks 6 days during current pregnancy
Vaginal bleeding, heavier than spotting, after 15 weeks 6 days
Amniotic membranes prolapsed beyond external os
Preterm rupture of membranes
Fetal anomaly
Pregnancy without a viable fetus
Current or planned cervical cerclage
Congenital Mullerian abnormality of the uterus
Contraindication to intra-muscular injections
Hypertension requiring medication
Diabetes managed with insulin or oral hypoglycemic agents
DES exposure
Cervical surgery such as cold knife conization
Planned indicated preterm delivery
Participation in another interventional study that influences age at delivery
Participation in this trial in a previous pregnancy
Prenatal care or delivery planned outside a MFMU Network center
Intervention: Rivaroxaban
Trial phase: Phase 3
ATC code: B01AF01
SMILES: O=C(NC[C@H]1CN(c2ccc(N3CCOCC3=O)cc2)C(=O)O1)c1ccc(Cl)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 598
Group description: Participants were to receive rivaroxaban 20 mg oral tablet once daily
Eligibility criteria:
Inclusion Criteria:

Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban

Exclusion Criteria:

Legal lower age limitations (country specific)
Indication for VKA other than DVT and/or PE
Patients in whom anticoagulant treatment for their index PE or DVT should be continued
Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP [Committee for Proprietary Medicinal Products]/ICH [International Conference on Harmonization]/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy
Intervention: Rivaroxaban
Trial phase: Phase 3
ATC code: B01AF01
SMILES: O=C(NC[C@H]1CN(c2ccc(N3CCOCC3=O)cc2)C(=O)O1)c1ccc(Cl)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1718
Group description: Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
Eligibility criteria:
Inclusion Criteria:

Confirmed acute symptomatic proximal DVT without symptomatic PE

Exclusion Criteria:

Legal lower age limitations (country specific)
Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE
Other indication for VKA than DVT and/or PE
The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from 36 hours to a maximum of 48 hours.
Intervention: Lincomycin
Trial phase: Phase 2
ATC code: J01FF02
SMILES: [H][C@@]1(C(=O)N[C@@H]([C@H]2O[C@H](SC)[C@H](O)[C@@H](O)[C@H]2O)[C@@H](C)O)C[C@@H](CCC)CN1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Eligibility criteria:
Inclusion Criteria:

History of migraines headaches for 1 year and well documented 3 month retrospective history of migraines.
Experience 2-8 migraines per month but not more than 15 headache days per month. There should be at least 48 hours of freedom between headaches.
On effective stable abortive medication(s) for the acute treatment of migraine.

Exclusion Criteria:

Subject in another investigational drug or device study within the last 30 days or is currently in another investigational drug trial.
Use of triptans or ergots for migraine abortive treatment > 2-3 days per calendar week 2 months prior to screening.
Experience 15 or more headache days per month of any kind 2 months prior to screening.
Has another consistent or chronic form of headache.
Unable to stop medications, herbs, vitamins, or minerals used to prevent a migraine from occurring.
Pregnant or nursing women and those of child bearing potential who are not surgically sterile, or 2 years post menopausal, or do not practice 2 combined methods of birth control, unless sexually abstinent, during the trial.
Significant laboratory or electrocardiograms (ECG) abnormalities
Significant medical history including cardiovascular abnormalities.
Intervention: Lincomycin
Trial phase: Phase 2
ATC code: J01FF02
SMILES: [H][C@@]1(C(=O)N[C@@H]([C@H]2O[C@H](SC)[C@H](O)[C@@H](O)[C@H]2O)[C@@H](C)O)C[C@@H](CCC)CN1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
Eligibility criteria:
Inclusion Criteria:

History of migraines headaches for 1 year and well documented 3 month retrospective history of migraines.
Experience 2-8 migraines per month but not more than 15 headache days per month. There should be at least 48 hours of freedom between headaches.
On effective stable abortive medication(s) for the acute treatment of migraine.

Exclusion Criteria:

Subject in another investigational drug or device study within the last 30 days or is currently in another investigational drug trial.
Use of triptans or ergots for migraine abortive treatment > 2-3 days per calendar week 2 months prior to screening.
Experience 15 or more headache days per month of any kind 2 months prior to screening.
Has another consistent or chronic form of headache.
Unable to stop medications, herbs, vitamins, or minerals used to prevent a migraine from occurring.
Pregnant or nursing women and those of child bearing potential who are not surgically sterile, or 2 years post menopausal, or do not practice 2 combined methods of birth control, unless sexually abstinent, during the trial.
Significant laboratory or electrocardiograms (ECG) abnormalities
Significant medical history including cardiovascular abnormalities.
Intervention: Nicotine
Trial phase: Phase 4
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 68
Group description: Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
Eligibility criteria:
Inclusion Criteria:

Adult ASA 1-2

Exclusion Criteria:

Cardiovascular disease
Former smoker
Pregnant
Nursing
Asthma
Intervention: Chloroquine
Trial phase: Phase 3
ATC code: P01BA01 | P01BB52
SMILES: CCN(CC)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 228
Group description: Subjects receive oral active-chloroquine (tablet 155 mg) + pyronaridine artesunate - placebo, once per day for 3 consecutive days (D0, 1, and 2).

The daily dose is 10 mg/kg on Days 0 and 1, and 5 mg/kg on Day 2 for children, and 620 mg on Days 0 and 1, and 310 mg on Day 2 for adults.
Eligibility criteria:
Inclusion Criteria:

Male or female patients between the age of 3 and 60 years, inclusive.
Body weight between 20 kg and 90 kg with no clinical evidence of severe malnutrition.

Presence of acute uncomplicated P. vivax mono-infection confirmed by:

Fever, as defined by axillary/tympanic temperature ≥37.5°C or oral/rectal temperature ≥38°C, or history of fever in the previous 24 hours (history of fever must be documented) and,
Positive microscopy of P. vivax with parasite density ≥250/ mcL of blood (including at least 50% of asexual parasites).
Written informed consent, in accordance with local practice, provided by patient and/or parent/guardian/spouse. If the patient is unable to write, witnessed consent is permitted according to local ethical considerations.
Ability to swallow oral medication.
Ability and willingness to participate based on information given to patient or parent or guardian and access to health facility.

Exclusion Criteria:

Presence of a mixed Plasmodium infection.
Presence of other clinical condition requiring hospitalization.
Presence of significant anaemia, as defined by Hb <8 g/dL.
Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, QTc interval ≥450 msec), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other abnormality (including recent head trauma).
Known history of hypersensitivity, allergic or adverse reactions to pyronaridine, chloroquine or artesunate or other artemisinins.
Known history of hypersensitivity, allergic or adverse reactions to chloroquine, primaquine and related agents.
Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab).
Known seropositive HIV antibody.
Have received any antimalarial treatment in the preceding 2 weeks, as determined by history and, whenever feasible, by screening test.
Have received antibacterial with known antimalarial activity in the preceding 2 weeks.
Have received any investigational drug within the past 4 weeks.
Liver function tests (AST/ALT levels) >2.5 times the upper limit of normal range.
Known significant renal impairment as indicated by serum creatinine levels of >1.4 mg/dL.
Female patients of child-bearing potential must be neither pregnant (as demonstrated by a negative pregnancy test) nor lactating, and must be willing to take measures to not become pregnant during the study period.
Previous participation in the present clinical trial with PA.
Intervention: Glufosfamide
Trial phase: Phase 2
SMILES: O=P(NCCCl)(NCCCl)O[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Glufosfamide

Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles.
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age
Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
Pathologically confirmed diagnosis of soft tissue sarcoma
Locally advanced unresectable or metastatic disease with no standard curative therapy available that has progressed since the most recent therapy
Measurable disease by RECIST criteria with at least one target lesion
1 or 2 prior chemotherapy/systemic therapy regimens for advanced disease
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
A minimum of 3 weeks between prior chemotherapy, radiation therapy, immunotherapy, or other anti-tumor therapy and study entry
Recovered from reversible toxicities of prior therapy
Hemoglobin ≥ 9.0 g/dL, neutrophils ≥ 1,500/µL, platelets ≥ 100,000/µL
Total bilirubin ≤ 1.5-fold ULN, AST/ALT ≤ 2.5-fold ULN (≤ 5-fold if liver metastases)
Normal creatinine clearance (≥85 mL/min for men and ≥75 mL/min for women; calculated by Cockcroft-Gault formula
All women of childbearing potential must have a negative serum pregnancy test and all subjects must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose

Exclusion Criteria:

Soft tissue sarcoma of the following subtypes: gastrointestinal stromal tumor (GIST), alveolar soft parts sarcoma, hemangiopericytoma and Kaposi's sarcoma
Most recent relapse occurring during treatment with ifosfamide within 4 weeks of last dose
Symptomatic brain or leptomeningeal metastases
Active clinically significant infection requiring antibiotics
Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, cerebrovascular accident or congestive heart failure
Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years
Major surgery within 3 weeks of the start of study treatment, without complete recovery
Females who are pregnant or breast-feeding
Participation in an investigational drug or device study within 21 days of study entry
Concomitant disease or condition that could interfere with the conduct of the study, or that in the opinion of the investigator would pose an unacceptable risk to the subject in this study
Unwillingness or inability to comply with the study protocol for any other reason
Intervention: Rezatomidine
Trial phase: Phase 2
SMILES: Cc1cccc([C@H](C)c2c[nH]c(=S)[nH]2)c1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Irritable Bowel Syndrome
Moderate or severe IBS pain

Exclusion Criteria:

Any other uncontrolled disease
Pregnant or nursing females
Intervention: Rezatomidine
Trial phase: Phase 2
SMILES: Cc1cccc([C@H](C)c2c[nH]c(=S)[nH]2)c1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Irritable Bowel Syndrome
Moderate or severe IBS pain

Exclusion Criteria:

Any other uncontrolled disease
Pregnant or nursing females
Intervention: Rezatomidine
Trial phase: Phase 2
SMILES: Cc1cccc([C@H](C)c2c[nH]c(=S)[nH]2)c1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Irritable Bowel Syndrome
Moderate or severe IBS pain

Exclusion Criteria:

Any other uncontrolled disease
Pregnant or nursing females
Intervention: Midazolam
Trial phase: Not Applicable
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 122
Group description: Patients received either etomidate or midazolam.
Eligibility criteria:
Inclusion Criteria:

All critically ill adult patients who present to the emergency department in need of ventilatory support and having a traumatic or suspected infectious etiology for their illness. Specifically, all patients meeting criteria for severe sepsis, septic shock, or the sepsis syndrome by fulfillment of two of the four criteria for the systemic inflammatory response syndrome (temperature greater than 38.3°C or less than 36°C, heart rate greater than 90, respiratory rate greater than 20 or PaCO2 less than 32, white blood cell count greater than 12,000 or less than 4000 or greater than 10% bands).
All patients presenting in respiratory distress from a presumed pulmonary source of infection and requiring ventilatory support.
All patients presenting after any traumatic injury and requiring ventilatory support.

Exclusion Criteria:

An age less than 18
Pregnancy
Do-not-resuscitate status
Intervention: Etomidate
Trial phase: Not Applicable
ATC code: N01AX07
SMILES: CCOC(=O)c1cncn1[C@H](C)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 122
Group description: Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the ED and in the ICU, was directed according to the treating physician.
Eligibility criteria:
Inclusion Criteria:

All critically ill adult patients who present to the emergency department in need of ventilatory support and having a traumatic or suspected infectious etiology for their illness. Specifically, all patients meeting criteria for severe sepsis, septic shock, or the sepsis syndrome by fulfillment of two of the four criteria for the systemic inflammatory response syndrome (temperature greater than 38.3°C or less than 36°C, heart rate greater than 90, respiratory rate greater than 20 or PaCO2 less than 32, white blood cell count greater than 12,000 or less than 4000 or greater than 10% bands).
All patients presenting in respiratory distress from a presumed pulmonary source of infection and requiring ventilatory support.
All patients presenting after any traumatic injury and requiring ventilatory support.

Exclusion Criteria:

An age less than 18
Pregnancy
Do-not-resuscitate status
Intervention: Aminophylline hydrate
Trial phase: Phase 3
SMILES: Cn1c(=O)c2[nH]cnc2n(C)c1=O.Cn1c(=O)c2[nH]cnc2n(C)c1=O.NCCN.O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Aminophylline 250 mg IV drip administration
Eligibility criteria:
Inclusion Criteria:

Adult participants with acute asthma attacks

Exclusion Criteria:

Participant has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., COPD, chronic heart failure, etc.).
Participant has a smoking habit (15 cigarettes per day) within a month prior to screening period, and/or has a smoking history (20 cigarettes per day) of more than 15 years.
Participant has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease.
Intervention: rhEPO
Trial phase: Phase 3
SMILES: COC1C(O)CC(=O)OC(C)CC=CC=CC(OC2CC(C)(O)C(O)C(C)O2)C(C)CC(CCO)C1OC1OC(C)C(OC2CC(C)(O)C(O)C(C)O2)C(N(C)C)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
Eligibility criteria:
Inclusion Criteria:

adult patients, >=18 years of age;
chronic kidney disease stage V;
on peritoneal dialysis for 3 months prior to screening;
on epoetin alfa sc >=3 months prior to screening.

Exclusion Criteria:

patients expecting to change dialysis modality over course of study;
patients hospitalized during previous 3 months for any clinically significant condition;
active malignancy;
bleeding episode necessitating transfusion, or overt gastrointestinal bleeding within 3 months prior to screening;
transfusion of red blood cells within 3 months prior to screening.