anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: URSODIOL
Trial phase: Phase 2
ATC code: A05AA01 | A05AA02
SMILES: CC(CCC(=O)O)C1CCC2C3C(O)CC4CC(O)CCC4(C)C3CCC12C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: tauroursodeoxycholic acid di-hydrate

tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year
Eligibility criteria:
Inclusion Criteria:

Caucasian male or female out-patients;
aged 18 to 75 years inclusive;
diagnosis of "probable" or "definite" amyotrophic lateral sclerosis according to the El Escorial revised criteria (1);
first symptoms of ALS by no more than 1.5 years;
in treatment with steady regimen of riluzole for a minimum of 3 months before study entry, and desiring its continuation;
FVC ≥ 75% of predicted;
no conditions known to be contraindications to the use of TUDCA;
written informed consent.

Exclusion Criteria:

subjects who underwent tracheostomy;
subjects who underwent resection of gall bladder;
subjects with signs of conduction blocks of motor nerves, sensory nerves or both on nerve conduction study;
subjects with clinical signs of dementia;
subjects with active peptic ulcer;
subjects with active malignancy;
subjects with bulbar onset;
female subjects who are pregnant or lactating
subjects who have received an experimental drug or have participated in a clinical trial within 3 months prior to screening
employees of the investigator or study centre with direct involvement in the proposed study or other studies under the direction of that investigator or study centre.
Intervention: Temsirolimus
Trial phase: Phase 1 | Phase 2
ATC code: L01EG01 | L01XE09
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(OC(=O)C(C)(CO)CO)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
Eligibility criteria:
Inclusion Criteria:

Patients with pathologically confirmed advanced or metastatic cancer that is refractory to standard therapy, relapsed after standard therapy, or has no standard therapy that improves survival by at least 3 months (unless temsirolimus is indicated as standard treatment for that disease).
Patients must have evaluable tumor(s) with documented PIK3 mutation and/or PTEN loss.
Patients must have creatinine </= 3 X upper limit of normal (ULN); absolute neutrophil count >/= 1,000/mL; platelets >/= 50,000; bilirubin </= 3.0 gm/dL. Except for patients with liver metastases: total bilirubin </= 5 ULN.
Women of childbearing potential must have a negative baseline blood pregnancy test. Women and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study.
Patients must be off other anti-tumor agents for at least 5 half lives of the agent or 4 wks from the last day of treatment, whichever is shorter. For cytotoxic therapies, patients should be off treatment for 3 or more weeks.
Patients may not be receiving any other experimental agents that are not FDA approved.
Ability to understand and willingness to sign a written consent document.
Treatment on this study may begin within 24 hours after Phase 0 dose of Temsirolimus.

Exclusion Criteria:

Pregnant or lactating women.
Patients with creatinine clearance <10 mL/min
Patients with a known hypersensitivity to any of the components or metabolites of the drug products.
Patients with major surgery within 30 days prior to entering study.
Patients on inhibitors or inducers of CYP3A4 metabolism will have the inhibitors or inducers stopped unless clinically contraindicated. See section 6 (Concomitant Medications) and Appendix E of the protocol for details.
Intervention: Famciclovir
Trial phase: Phase 2 | Phase 3
ATC code: J05AB09 | S01AD07
SMILES: CC(=O)OCC(CCn1cnc2cnc(N)nc21)COC(C)=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 53
Group description: Participants received single oral doses of three 500 milligrams (mg) Famciclovir tablets on Day 1.
Eligibility criteria:
Inclusion Criteria:

Outpatient males or females 12 to <18 years of age
General good health with a documented history typical for recurrent herpes labialis

Prodromal symptoms or active lesions suggestive of a recurrent episode of herpes labialis (i.e. having had cold sores in the past) , with onset not exceeding 24 hours until the time of study drug administration

Adolescents participating in Pharmacokinetics (PK) part of the study may be enrolled without an active herpes labialis recurrence or with onset of signs/symptoms of a recurrent herpes labialis episode longer than 24 hours before study drug administration, All adolescents participating in the pharmacokinetics assessments must fast for at least 8 hours prior to Visit 1 and be willing to fast for an additional 2 hours after study drug administration

Exclusion Criteria:

Use of other investigational drugs within 30 days of enrollment
History of hypersensitivity to famciclovir or penciclovir
Inability to swallow tablets
Body weight less than 40 Killograms (kg)
History of malabsorption, unless a condition like celiac disease is stable and well controlled, previous gastrointestinal surgery or radiation therapy that could affect drug absorption or metabolism, or any condition that could interfere with drug absorption, distribution, metabolism, or excretion
Known renal insufficiency (calculated creatinine clearance <60 [Milliliters/Minutes] mL/min)
Known severe hepatic impairment (Child-Pugh Class C)
Significant skin disease such as atopic dermatitis or eczema that would interfere with assessment of oral/labial lesions
Known to be immunocompromised or are receiving systemic or using topical immunosuppressive agents (including corticosteroids, tacrolimus and picrolimus) within 30 days of enrollment
Concomitant use of probenecid
Pregnant or nursing (lactating) females
Females of child-bearing potential, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.
Intervention: Ondansetron
Trial phase: Phase 4
ATC code: A04AA01
SMILES: Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 98
Group description: The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
Eligibility criteria:
Inclusion Criteria:

All patients of Dr. Coleman or Dr. Kelly ages 18 to 65 undergoing arthroscopic hip surgery
Planned use of neuraxial anesthesia
Ability to follow study protocol
Willing to complete daily diary and be interviewed daily for three days after discharge

Exclusion Criteria:

Patients younger than 18 years old and older than 65
Patients unable to undergo a spinal or epidural anesthetic
Having nausea or vomiting within 24 hours of the surgery
Receiving drugs with anti-emetic properties within 24 hours of the surgery (e.g Zofran, Compazine, Phenergan, Reglan)
Chronic opioid use (defined as daily or almost daily use of opioids for >3 months)
Hypersensitivity and/or allergy to ondansetron
Intraoperative use of any volatile anesthetic
Contraindication to a short course of NSAIDs (renal failure, intolerance)
Allergy or intolerance to Vicodin
Intervention: Neratinib
Trial phase: Phase 3
ATC code: L01EH02
SMILES: CCOc1cc2ncc(C#N)c(Nc3ccc(OCc4ccccn4)c(Cl)c3)c2cc1NC(=O)/C=C/CN(C)C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1408
Group description: Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
Eligibility criteria:
Inclusion Criteria:

Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.
Been treated for early breast cancer with standard of care duration of trastuzumab.
Could have been treated neoadjuvantly but have not reached pathologic complete response.

Exclusion Criteria:

Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
History of heart disease.
Corrected QT (QTc) interval >0.45 seconds
History of gastrointestinal disease with diarrhea as the major symptom.
Intervention: Lovenox
Trial phase: Phase 2 | Phase 3
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 11
Group description: 40 mg Enoxaparin injection daily
Eligibility criteria:
Inclusion Criteria:

>18 years of age
Warrants prophylaxis against venous thromboembolism in pregnancy according to American College of

Obstetrics and Gynecology Practice Bulletin 2000, reaffirmed in 2008:

history of idiopathic thrombosis
history of thrombosis related to pregnancy or oral contraceptive use
history of thrombosis accompanied by an underlying thrombophilia other than homozygous for the factor V Leiden mutation, heterozygous for both the factor V Leiden and the prothrombin G20210A mutation, or AT-III deficiency
without a history of thrombosis but who have an underlying thrombophilia and a strong family history of thrombosis
Known thrombophilia except for those listed above, with a history of adverse pregnancy outcome (APO) as defined by: ¡Ý3 pregnancy losses in the 1st trimester, ¡Ý2 pregnancy losses/stillbirth in 2nd trimester, ¡Ý1 pregnancy loss/intrauterine fetal demise (IUFD) in the 3rd trimester, intrauterine growth restriction (IUGR), abruptio placentae, or severe pre-Eclampsia prior to 34 weeks gestation.

Exclusion Criteria:

Need for therapeutic-level anticoagulation as determined by physician
Renal disease as defined by serum creatinine >1.0
Weight >90kg
Allergy to enoxaparin
Intervention: Lovenox
Trial phase: Phase 2 | Phase 3
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 11
Group description: 1 mg/kg Enoxaparin injection daily
Eligibility criteria:
Inclusion Criteria:

>18 years of age
Warrants prophylaxis against venous thromboembolism in pregnancy according to American College of

Obstetrics and Gynecology Practice Bulletin 2000, reaffirmed in 2008:

history of idiopathic thrombosis
history of thrombosis related to pregnancy or oral contraceptive use
history of thrombosis accompanied by an underlying thrombophilia other than homozygous for the factor V Leiden mutation, heterozygous for both the factor V Leiden and the prothrombin G20210A mutation, or AT-III deficiency
without a history of thrombosis but who have an underlying thrombophilia and a strong family history of thrombosis
Known thrombophilia except for those listed above, with a history of adverse pregnancy outcome (APO) as defined by: ¡Ý3 pregnancy losses in the 1st trimester, ¡Ý2 pregnancy losses/stillbirth in 2nd trimester, ¡Ý1 pregnancy loss/intrauterine fetal demise (IUFD) in the 3rd trimester, intrauterine growth restriction (IUGR), abruptio placentae, or severe pre-Eclampsia prior to 34 weeks gestation.

Exclusion Criteria:

Need for therapeutic-level anticoagulation as determined by physician
Renal disease as defined by serum creatinine >1.0
Weight >90kg
Allergy to enoxaparin
Intervention: Caffeine
Trial phase: Phase 2
ATC code: D11AX26 | N06BC01 | R03DA20 | V04CG30
SMILES: Cn1c(=O)c2c(ncn2C)n(C)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
Eligibility criteria:
Inclusion Criteria:

Advanced (Stage IV) cancer inpatients
Adults aged over 18 years
Patients who have received opioid therapy and whose pain scales are under 6 (by numeric rating scale)
Patients who do not take caffeine beverage 48 hours before study period
Volunteers who provided written informed consent

Exclusion Criteria:

Sensitivity (palpitation,headache,irritability,insomnia) to caffeine
Uncontrolled hypertension and/or heart disease
Liver failure (alanine aminotransferase >= 100 IU/L)
Kidney failure (serum creatinine >= 2.0 mg/dL)
Patients taken theophylline
Gastroesophageal reflux disease
Chronic glaucoma
Cognitive impairment
Progressive pain over 7 (by numeric rating scale)
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Intravenous injections of 100ml of normal saline over 1 hour
Eligibility criteria:
Inclusion Criteria:

Advanced (Stage IV) cancer inpatients
Adults aged over 18 years
Patients who have received opioid therapy and whose pain scales are under 6 (by numeric rating scale)
Patients who do not take caffeine beverage 48 hours before study period
Volunteers who provided written informed consent

Exclusion Criteria:

Sensitivity (palpitation,headache,irritability,insomnia) to caffeine
Uncontrolled hypertension and/or heart disease
Liver failure (alanine aminotransferase >= 100 IU/L)
Kidney failure (serum creatinine >= 2.0 mg/dL)
Patients taken theophylline
Gastroesophageal reflux disease
Chronic glaucoma
Cognitive impairment
Progressive pain over 7 (by numeric rating scale)
Intervention: Losartan
Trial phase: Not Applicable
ATC code: C09CA01 | C09DA01 | C09DB06
SMILES: CCCCc1nc(Cl)c(CO)n1Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: 50 mg tablets of losartan taken daily by mouth for 1 year

losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year
Eligibility criteria:
INCLUSION CRITERIA:

Age > 21 years
Diagnosis of idiopathic pulmonary fibrosis
Patients taking Coumadin and/or N-acetylcysteine may participate in the study
Baseline forced vital capacity (FVC) must be greater than or equal to 50%
Baseline 6 minute walk test distance walked must be greater than or equal to 200 meters not requiring greater than 6 lpm of oxygen

EXCLUSION CRITERIA:

Pregnant, intending to become pregnant or breastfeeding
Current or previous smoker of cigarettes or marijuana that recently quit within the last 6 months prior to enrollment
Allergy or allergic reaction to Losartan or any other angiotensin II receptor blocker
Taking losartan or any other angiotensin II receptor blocker
Baseline systolic blood pressure < 100 mmHg
Currently taking or has taken immunosuppressant agents within the last month such as azathioprine, cyclophosphamide, colchicine and/or prednisone
History of lung transplant
History of kidney failure or liver disease
Inability to attend clinic visits
Intervention: Buprenorphine Hydrochloride
Trial phase: Phase 4
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 54
Group description: Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
Eligibility criteria:
Inclusion Criteria:

chronic back pain
opioid addiction
not successful with abstinence
at least 18 years old
able to understand spoken English
live in Western New York State (Erie or Niagara county)
have health insurance or ability to pay for health care
no methadone or buprenorphine treatment within past year
not member of a vulnerable population (e.g., pregnancy, prisoner)

Exclusion Criteria:

homelessness
unable to give consent (e.g., dementia, psychosis)
serious heart or lung disease
taking a medication that could interact with methadone or buprenorphine
pregnancy
Intervention: Morphine
Trial phase: Phase 4
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 84
Group description: Receives a single dose of intrathecal morphine

Intrathecal morphine: Morphine injection is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain.
Eligibility criteria:
Inclusion Criteria:

Male and females, 8 to17 years old undergoing posterior spinal fusion for idiopathic scoliosis.
Fusion of a minimum of 5, and a maximum of 13 levels, including at least L1 or lower.

Exclusion Criteria:

Neuromuscular scoliosis.
A history of documented coagulopathy or platelet count of less than 100,000 mm3.
A known allergy or adverse sensitivity to morphine.
Pulmonary hypertension or other significant respiratory problem.
Cognitive deficits that would impair use of PCA and/or filling out questionnaire.
History of sleep apnea defined by sleep study and/or need for nighttime CPAP.
Abnormal pain thresholds (i.e., subjects who are on significant opioids preoperatively).
Baseline neurologic deficits (numbness, motor deficits, or any focal neurological sign).
Subjects who are anticipated to remain intubated postoperatively for longer than 2 hours.
Need for preoperative intravenous inotropic drugs.
Significant metabolic, endocrine or neuropathology, cyanosis, or renal insufficiency.
A contraindication to dural puncture, such as raised intracranial pressure.
Pre-operative heparin, oral aspirin or anticoagulants.
Weight less than 20kg or greater than 100kg.
Need for Intraoperative ketamine administration.
Intervention: Lansoprazole
Trial phase: Not Applicable
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Receives steroids and PPI only- Does not have esophageal dilation.
Eligibility criteria:
Inclusion Criteria:

Male and female volunteers ≥18 years old.
Patients with known or suspected Eosinophilic Esophagitis.
Patients undergoing upper endoscopy for recent food impaction or complaint of dysphagia.

Exclusion Criteria:

Use of oral corticosteroids.
Significant medical conditions that in the investigator's judgment would compromise the subject's health and safety.
Contraindication to esophageal dilation based on investigator's judgment.
Esophageal motility abnormalities not thought to be related to Eosinophilic Esophagitis.
Intervention: Telapristone acetate
Trial phase: Phase 1
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.

Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days
Eligibility criteria:
Inclusion Criteria:

Clinical laboratory tests within normal ranges
A normal menstrual period of 26-30 days
Desiring not to become pregnant
Agreeing to use a double barrier method of birth control for the duration of the trial

Exclusion Criteria:

Post-menopausal status
Aamenorrhea or dysfunctional uterine bleeding
Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile
Subjects with a Body Mass Index (BMI) below 18 or over 39
Intervention: Telapristone acetate
Trial phase: Phase 1
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.

Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days
Eligibility criteria:
Inclusion Criteria:

Clinical laboratory tests within normal ranges
A normal menstrual period of 26-30 days
Desiring not to become pregnant
Agreeing to use a double barrier method of birth control for the duration of the trial

Exclusion Criteria:

Post-menopausal status
Aamenorrhea or dysfunctional uterine bleeding
Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile
Subjects with a Body Mass Index (BMI) below 18 or over 39
Intervention: Telapristone acetate
Trial phase: Phase 1
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.

Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days
Eligibility criteria:
Inclusion Criteria:

Clinical laboratory tests within normal ranges
A normal menstrual period of 26-30 days
Desiring not to become pregnant
Agreeing to use a double barrier method of birth control for the duration of the trial

Exclusion Criteria:

Post-menopausal status
Aamenorrhea or dysfunctional uterine bleeding
Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile
Subjects with a Body Mass Index (BMI) below 18 or over 39
Intervention: Telapristone acetate
Trial phase: Phase 1
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.

Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days
Eligibility criteria:
Inclusion Criteria:

Clinical laboratory tests within normal ranges
A normal menstrual period of 26-30 days
Desiring not to become pregnant
Agreeing to use a double barrier method of birth control for the duration of the trial

Exclusion Criteria:

Post-menopausal status
Aamenorrhea or dysfunctional uterine bleeding
Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile
Subjects with a Body Mass Index (BMI) below 18 or over 39