anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tretinoin
Trial phase: Phase 2
ATC code: D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02
SMILES: CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O
Sex: Male
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: 20 mg 13-cis retinoic acid twice daily (BID) with meals for 20 weeks
Eligibility criteria:
Inclusion Criteria:

Subjects will be infertile men (no pregnancy with partner with normal cycles and normal hysterosalpingogram despite >1 year of unprotected intercourse).
Abnormal sperm analyses with a total, motile sperm count of less than 10 million sperm as assessed by semen analysis on two occasions separated by one week.
In the opinion of the investigator, is able to comply with the protocol, understand and sign an informed consent and HIPAA (Health Insurance Portability and Accountability Act ) form.

Exclusion Criteria:

Men participating in another clinical trial
Men not living in the catchment area of the clinic
Clinically significant abnormal findings at screening
Known genetic infertility (e.g. Klinefelter syndrome or Y-chromosome microdeletions),
Hypogonadotropic hypogonadism (that might respond to gonadotropin injections),
The use of anabolic steroids, illicit drugs, or the consumption of more than 4 alcoholic beverages daily
Severe mental health problems requiring medications
Current therapy with retinoic acid (e.g. Accutane) or vitamin A.
Score of greater than 15 on the Patient health questionnaire (PHQ9).
Abnormal serum chemistry values according to local laboratory normal values which indicate liver or kidney dysfunction. Other abnormal lab values may also be exclusionary, at the discretion of the investigator
Men with a personal history of serious psychiatric disorders
Men currently receiving tetracycline containing medications
Men currently receiving phenytoin
Men with a history of inflammatory bowel disease
Men with a history of bone disease
Men who have used isotretinoin within eight weeks of the start of dosing
Men with elevated serum triglycerides
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: 1g intravenous acetaminophen over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours; maximum dose of 4 grams in 24 hours

Acetaminophen: 1 gram of intravenous Acetaminophen
Eligibility criteria:
Inclusion Criteria:

Age > 18 years old
Being scheduled to have elective primary minimally invasive 1 or 2 level transforaminal lumbar laminectomy interbody fusion
ASA I, II, or III
Informed consent form signed

Exclusion Criteria:

Anyone weighing less than 50kg (as this would require a dosing change).
Hypersensitivity or contraindication to intravenous acetaminophen or opioids
Allergy to Methocarbamol; morphine sulfate, sevoflourane, or fentanyl
Impairment of liver function-- defined as the inability to receive intravenous acetaminophen without dose adjustment as determined by the investigator; or history of chronic liver disease defined as history of hepatitis of any kind as recorded in the patient's chart
Mental retardation recorded as a diagnosis in the patient's chart
History of chronic pain (defined as currently receiving treatment from a specialist for pain)
History of pain recalcitrant to intravenous morphine
Impaired kidney function (defined as creatinine > 1.5)
Anyone who is not a candidate for general anesthesia or any other portion of the investigator's standard of
Intervention: Sirolimus
Trial phase: Not Applicable
ATC code: L01EG04 | L04AA10 | S01XA23
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: SRL minimization will be performed if clinically, biochemically and histologically stable. Patients entering the minimization phases will be reduced every month by 50% of total dose of Sirolimus until they reach .5mg daily for one month. Then .5 mg every other day, then twice weekly, the once weekly dosing. This should take approximately 6 month to complete minimization. Liver function tests will be monitored every 2 weeks. For any patient developing liver dysfunction, liver biopsy will be performed. Patients will then be completely withdrawn and followed post-withdrawal for 12 months.

Sirolimus: SRL minimization will be performed if clinically, biochemically and histologically stable. Patients entering the minimization phases will be reduced every month by 50% of total dose of Sirolimus until they reach .5mg daily for one month. Then .5 mg every other day, then twice weekly, the once weekly dosing. This should take approximately 6 month to complete minimization. Liver function tests will be monitored every 2 weeks. For any patient developing liver dysfunction, liver biopsy will be performed. Patients will then be completely withdrawn and followed post-withdrawal for 12 months.
Eligibility criteria:
Inclusion Criteria:

Adult male and female recipients of all races, ≥ 18-75 years of age
Patients who underwent primary living or deceased donor liver transplantation ≥ 3 years (previous to screening ) and on ≥ 3 months of stable SRL monotherapy
Recipient of single organ transplant only
Liver transplant for non-immune, non-viral (no hepatitis B or hepatitis C virus unless currently non-viremic) causes
Ability to provide informed consent and to comply with the study protocol of IS withdrawal.

Exclusion Criteria:

Inability or unwillingness to provide informed consent
Acute cellular rejection within 12 months prior to enrollment
Viral (viremic hepatitis B virus [HBV] or hepatitis C virus [HCV]) or immune-mediated liver disease (Autoimmune hepatitis, primary sclerosing cholangitis, primary biliary cirrhosis) history
Abnormal liver function tests: Direct bilirubin ≥ 1 mg/dL; ([ALT, AST, GGT] or alkaline phosphatase [AlkPhos] ≥ 2x [ULN]); 5) Abnormal graft histology at enrollment: a) ≥ Grade 2 inflammation or stage 2 fibrosis; b) Acute or Chronic Rejection; c) De-novo Autoimmune Hepatitis; d) inflammation of >50% of portal tracts; e) Other pathology not-specified but deemed high risk per the PI and pathologist; 6) Ongoing or recurrent substance abuse

7) Retransplantation or combined liver-other organ 8) Human Immunodeficiency Virus(HIV) co-infection 9) Glomerular Filtration Rate (GFR)<30 ml/min by estimated glomerular filtration rate ([eGFR]-[MDRD-4])
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 102
Group description: control group

Acetaminophen: acetaminophen for pain control with dose and frequency of 10-15mg/kg/dose, Maximum dose 1000mg. Maximum amount per day: 75mg/kg (not to exceed 4g/day).
Eligibility criteria:
Inclusion Criteria:

• Male aged 16 years or less or female aged 14 years or less

Open physis on radiographs
Fracture undergoing closed treatment or operative treatment or patient undergoing elective osteotomy

Exclusion Criteria:

• Regular use of NSAIDs

Allergy to NSAIDs
Inability to take breakthrough medications due side effects or allergy
Systemic illness
Renal impairment
Liver disease
Polytrauma
Uncontrolled diabetes
Regular use of corticosteroids
History of any skeletal dysplasia
History of neuromuscular disorder
History of bleeding disorder
History of liver disorder
Pathologic fracture
Closed physes
Male greater than 16 years old
Female greater than 14 years old
Pregnant or possibly pregnant females based on report and last menstrual period
Intervention: Methotrexate
Trial phase: Not Applicable
ATC code: L01BA01 | L04AX03
SMILES: CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Individualized high dose methotrexate given as a 24-hour infusion.

Methotrexate: Patients will receive 5g/m^2 high dose methotrexate as a 24 hour infusion.

The methotrexate level in the blood will be checked at two times during the 24-infusion. The dose will be reduced based on the level in the blood.
Eligibility criteria:
Inclusion Criteria:

Age: Patients must be greater than or equal to 365 days and less than 23 years of age at the time of enrollment.

Diagnosis: Patients with any malignancy who will receive high dose methotrexate (HDMTX) given as a 5 g/m2 infusion over 24 hours and a history of ≥ 1 of the following:

Documented decreased renal function, defined as Creatinine greater than 1.5 x baseline or glomerular filtration rate (GFR) <65ml/min/1.73m2.
History of prior nephrotoxicity with HDMTX as evidence by increased creatinine to 1.5 x baseline or need for dialysis or carboxypeptidase
History of Grade 3 adverse event (AE) related to HDMTX (mucositis, myelosuppression, nephrotoxicity, hepatotoxicity) based on the NIH Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Provider concern patient is at risk for MTX toxicity, such as a prior history of treatment with nephrotoxic chemotherapy, history of HDMTX-related neurotoxicity, or antimicrobial/antifungal therapy

Exclusion Criteria:

Unable to draw labs for HDMTX serum concentration
Enrollment on a protocol (COG or other) which restricts proposed dose modifications
Patients with Trisomy 21
Patients with greater than grade 1 neurologic toxicity at the time of enrollment that is attributed to unresolved prior methotrexate toxicity
Patients with greater than or equal to grade 3 chronic kidney disease at enrollment (eGFR or creatine clearance (CrCl) less than 30ml/min/1.73m2)
Intervention: Sodium fluoride and triclosan
Trial phase: Phase 4
SMILES: Oc1cc(Cl)ccc1Oc1ccc(Cl)cc1Cl.[F-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 135
Group description: Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland

Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste
Eligibility criteria:
Inclusion Criteria:

Subjects, ages 18-70, inclusive.
Availability for the six-month duration ofthe clinical research study.
Good general health.
Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
Signed Informed Consent Form.

Exclusion Criteria:

Presence of orthodontic bands.
Presence of partial removable dentures.
Tumor(s) of the soft or hard tissues of the oral cavity.
Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
Five or more carious lesions requiring immediate restorative treatment.
Antibiotic use any time during the one month prior to entry into the study.
Participation in any other clinical study or test panel within the one month prior to entry into the study.
Dental prophylaxis during the past two weeks prior to baseline examinations.
History of allergies to oral care/personal care consumer products or their ingredients.
On any prescription medicines that might interfere with the study outcome.
An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
History of alcohol or drug abuse.
Pregnant or lactating subjects.
Intervention: Dopamine
Trial phase: Phase 2
ATC code: C01CA04
SMILES: NCCc1ccc(O)c(O)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 131
Group description: Placebo BID for 7 weeks

levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.

Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance.
Eligibility criteria:
Inclusion Criteria:

Male and female subjects
Age 18 to 50
Meet current DSM-IV criteria for cocaine dependence who are seeking treatment.

Exclusion Criteria:

Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, nicotine, or alcohol
Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
Significant current suicidal or homicidal ideation
Medical conditions contraindicating levodopa/carbidopa or pharmacotherapy (e.g., evidence of any movement disorder, clinically significant pulmonary disease, cardiovascular disease, liver or kidney disease, seizure disorder)
Taking CNS active concomitant medications
Taking medications known to have significant drug interactions with the study medication (e.g., CYP P-450-2D6 inhibitors, such as tamoxifen, iron salts, pyridoxine, monoamine oxidase inhibitors, phenothiazines, selegiline, anesthetics)
Having conditions of probation or parole requiring reports of drug use to officers of the court
Impending incarceration
Pregnant or breast feeding for female patients
Inability to read, write, or speak English
Having plans to leave the immediate geographical area within 3 months
Unwillingness or not competent to sign a written informed consent form
Individuals who have pacemakers, metal or electromechanical implants or metallic foreign bodies
Patients who are known to be HIV positive will not be included due to possible CNS effects of HIV.
Alcohol withdrawal symptoms or history of significant previous alcohol withdrawal symptoms
Intervention: Dopamine
Trial phase: Phase 2
ATC code: C01CA04
SMILES: NCCc1ccc(O)c(O)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 131
Group description: Levodopa/carbidopa 400/100 BID for 7 weeks

levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.

Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance.
Eligibility criteria:
Inclusion Criteria:

Male and female subjects
Age 18 to 50
Meet current DSM-IV criteria for cocaine dependence who are seeking treatment.

Exclusion Criteria:

Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, nicotine, or alcohol
Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
Significant current suicidal or homicidal ideation
Medical conditions contraindicating levodopa/carbidopa or pharmacotherapy (e.g., evidence of any movement disorder, clinically significant pulmonary disease, cardiovascular disease, liver or kidney disease, seizure disorder)
Taking CNS active concomitant medications
Taking medications known to have significant drug interactions with the study medication (e.g., CYP P-450-2D6 inhibitors, such as tamoxifen, iron salts, pyridoxine, monoamine oxidase inhibitors, phenothiazines, selegiline, anesthetics)
Having conditions of probation or parole requiring reports of drug use to officers of the court
Impending incarceration
Pregnant or breast feeding for female patients
Inability to read, write, or speak English
Having plans to leave the immediate geographical area within 3 months
Unwillingness or not competent to sign a written informed consent form
Individuals who have pacemakers, metal or electromechanical implants or metallic foreign bodies
Patients who are known to be HIV positive will not be included due to possible CNS effects of HIV.
Alcohol withdrawal symptoms or history of significant previous alcohol withdrawal symptoms
Intervention: Metformin
Trial phase: Phase 4
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Participants randomized to the metformin arm of the study will receive this medication from months 1 through 12 after randomization. Subjects will receive 850 mg daily for 1 month and increase to 850 mg twice daily thereafter if no side effects are experienced.

Metformin Therapy: Participants in this group will receive metformin 850 mg bid for one year.
Eligibility criteria:
Inclusion Criteria:

Female gender
Latino ethnicity
Spanish fluency
Age ≥20 years
BMI ≥25 kg/m2
And "increased risk of diabetes" (ADA Diabetes Risk Score ≥4 as determine by 7-item questionnaire and hemoglobin A1C ≥ 5.6%)

Exclusion Criteria:

Hemoglobin A1C ≥ 6.5%
Current or planned pregnancy during the study period
Chronic conditions that could affect potential participants' ability to participate (osteoarthritis, heart disease, pulmonary disease requiring oxygen or daily bronchodilator use, and severe psychiatric disease)
Medical comorbidities that could influence weight loss or weight gain (thyroid disease, cancer, and HIV)
Medications that could affect weight or glucose metabolism (thiazide diuretics, β-blockers, and systemic glucocorticoids).
Intervention: Morphine sulfate pentahydrate
Trial phase: Phase 2
SMILES: CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O.O.O.O.O.O=S(=O)(O)O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: 0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections
Eligibility criteria:
Inclusion Criteria:

Elective primary cesarean section
Females age 18-40

Exclusion Criteria:

Emergency cesarean section
Anesthetic other than spinal
History of chronic pain or pre-op opioid use
Allergy to morphine or hydromorphone
BMI>40
Intervention: Latanoprost
Trial phase: Phase 3
ATC code: S01EE01 | S01EE51
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 119
Group description: Once daily

Latanoprost ophthalmic solution
Eligibility criteria:
Inclusion Criteria:

Subjects with diagnosis of bilateral primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

Subjects with ocular conditions as defined by the protocol
Intervention: Methadone
Trial phase: Phase 4
ATC code: N02AC52 | N07BC02
SMILES: CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 120
Group description: Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)

Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia
Eligibility criteria:
Inclusion Criteria:

All patients presenting for elective posterior lumbar or thoracic spinal fusion surgery will be eligible for enrollment.

Exclusion Criteria:

Preoperative renal failure (defined as a serum creatinine > 2.0 mg/dL.)
American Society of Anesthesiologists Physical Status IV or V
Pulmonary disease necessitating home oxygen therapy
Allergy to methadone or hydromorphone
Preoperative recent history of opioid or alcohol abuse
Inability to use a PCA device or speak the English language
Intervention: Latanoprost
Trial phase: Phase 1
ATC code: S01EE01 | S01EE51
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Once daily

Latanoprost ophthalmic solution
Eligibility criteria:
Inclusion Criteria:

Subjects who are considered medically healthy per investigator's judgment

Exclusion Criteria:

Subjects with ocular conditions as defined by the protocol
Subjects with intraocular pressure: <10 or ≥22 mmHg
Intervention: Perflutren
Trial phase: Not Applicable
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Infusion of Definity (Perflutren Lipid Microspheres)

Definity infusion: 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min
Eligibility criteria:
Inclusion Criteria:

Females
Be diagnosed with T1 or greater LABC, any N and M0.
Be scheduled for neoadjuvant chemotherapy
Be at least 21 years of age.
Be medically stable.
If a female of child-bearing potential, must have a negative pregnancy test.
Have signed Informed Consent to participate in the study.

Exclusion Criteria:

Males
Females who are pregnant or nursing.
Patients with other primary cancers requiring systemic treatment.
Patients with any metastatic disease.
Patients undergoing neoadjuvant endocrine therapy.
Patients with known hypersensitivity or allergy to any component of Definity.
Patients with cardiac shunts or congenital heart defects.
Patients with unstable cardiopulmonary conditions or respiratory distress syndrome.
Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli.
Patients who have received any contrast medium (X-ray, MRI, CT or US) in the 24 hours prior to the research US exam.
Intervention: Dovitinib
Trial phase: Phase 2 | Phase 3
SMILES: CN1CCN(c2ccc3nc(-c4c(N)c5c(F)cccc5[nH]c4=O)[nH]c3c2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).
Eligibility criteria:
Inclusion Criteria:

patient was currently enrolled in Novartis sponsored study, which had met its endpoint and was receiving single agent oral dovitinib or dovitinib and fulvestrant coadministration
patient was currently benefiting from treatment with single agent oral dovitinib or dovitinib and fulvestrant coadministration as determined by the guidelines of the parent protocol and according to the investigator's clinical judgment.
patient had demonstated compliance
patient had given written informed consent.

Exclusion Criteria:

patient had been permanently discontinued from oral dovitinib study treatment, either alone or in combination with fulvestrant, in the parent study
patient was pregnant or nursing at the time of entry
women of child-bearing potential and male patients with sexual partners of child-bearing potential unwilling to use highly effective methods of contraception during dosing and for a specified duration after stopping study treatment