anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sufentanil
Trial phase: Phase 3
ATC code: N01AH03
SMILES: CCC(=O)N(c1ccccc1)C1(COC)CCN(CCc2cccs2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 114
Group description: Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
Eligibility criteria:
Inclusion Criteria:

Male or female patients who are 18 years or older
Patients who are scheduled to undergo an open abdominal surgery (including laparoscopic-assisted) under general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation.
Post-surgical patients who have been admitted to the PACU and are expected to remain hospitalized and to have acute post-operative pain requiring parenteral opioids for at least 48 hours after surgery.

Exclusion Criteria:

Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet).
Patients with an allergy or hypersensitivity to opioids.
Female patients who are pregnant or breast-feeding
Intervention: ULIPRISTAL ACETATE
Trial phase: Not Applicable
SMILES: CC(=O)O[C@]1(C(C)=O)CC[C@H]2[C@@H]3CCC4=CC(=O)CCC4=C3[C@@H](c3ccc(N(C)C)cc3)C[C@@]21C
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 274
Group description: Women in this arm will receive the oral Ulipristal acetate (Ella) regimen, which is currently the most effective method of oral emergency contraception.

Ulipristal acetate: 30 mg tablet
Eligibility criteria:
Inclusion Criteria:

Women age 14-45
Under-protected intercourse within the last five days (120 hours)
Willingness to accept either intervention: intrauterine contraception or oral emergency contraception (EC)
Ability and willingness to follow-up for in clinic urine pregnancy test (UPT)
Ability and willingness to be contacted by phone for 6 and 12 month follow-up

Exclusion Criteria:

Positive pregnancy test
Non-English speaking
Contraindication to intrauterine contraception or oral EC
Inability or unwillingness to comply with follow-up
Intervention: Deferiprone
Trial phase: Phase 2
ATC code: V03AC02
SMILES: Cc1c(O)c(=O)ccn1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: 20mg/kg/day deferiprone divided into two equal doses (morning and evening), every day for 6 months
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of Parkinson's disease
disease duration less than 5 years
stable response to standard anti-Parkinson's medication for at least 6 weeks

Exclusion Criteria:

Other neurological conditions
Diabetes
Renal or liver disease
Blood disorders
Pregnancy or breast feeding
Conditions which cause immunocompromise e.g. episodes of neutropaenia or agranulocytosis, HIV etc
Prior history of hypersensitivity to Deferiprone or its excipient
Pacemaker
artificial heart valves
ever had surgery to the head
Metalic implants in the CNS e.g. cerebral aneurysm clips
history of metal entering the eye
Intervention: Deferiprone
Trial phase: Phase 2
ATC code: V03AC02
SMILES: Cc1c(O)c(=O)ccn1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: 30mg/kg/day Deferiprone divided into two equal doses (morning and evening), every day for 6 months
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of Parkinson's disease
disease duration less than 5 years
stable response to standard anti-Parkinson's medication for at least 6 weeks

Exclusion Criteria:

Other neurological conditions
Diabetes
Renal or liver disease
Blood disorders
Pregnancy or breast feeding
Conditions which cause immunocompromise e.g. episodes of neutropaenia or agranulocytosis, HIV etc
Prior history of hypersensitivity to Deferiprone or its excipient
Pacemaker
artificial heart valves
ever had surgery to the head
Metalic implants in the CNS e.g. cerebral aneurysm clips
history of metal entering the eye
Intervention: 18-(p-Iodophenyl)octadecyl phosphocholine
Trial phase: Not Applicable
SMILES: C[N+](C)(C)CCOP(=O)([O-])OCCCCCCCCCCCCCCCCCCc1ccc(I)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Participants injected with 185 MBq ± of 124I-CLR1404 intravenously over a period of 1 to 2 minutes, followed by a flush of 10 mL of normal saline. Subjects returned for PET/CT imaging at 6-, 24-, and 48-hours post-injection.

Participants received 3 drops of potassium iodide by mouth (1 gm/ml) 1 to 24 hours prior to injection of 124I-CLR1404 and continued additional daily doses prior to each PET/CT scan for 3 consecutive days.
Eligibility criteria:
Inclusion Criteria:

Participants will have a contrast enhanced brain MRI which documents evidence of primary or metastatic brain tumor or suspected tumor recurrence after therapy
Tumor size at least 1.5 cm in greatest axial dimension on MRI. MRI must be obtained within 2 months of study inclusion
Adult patients 18 or older
Female patients must not be pregnant or breast feeding and both women of childbearing potential, and men, must use appropriate means of contraception and must be maintained for at least 45 days after injection of 124I-NM404 Participants must not attempt to become pregnant during this time
Platelet count must be ≥ 160,000/µl, Hematocrit must be ≥ 22%, Leukocyte count must be ≥ 3,000/µL, Creatinine must be ≤ 2.5 mg/dL, ALT must be ≤ 130 U/L, AST must be ≤ 100 U/L, and urine or serum pregnancy test must be negative for pregnancy
Patient provides informed consent
Karnofsky score ≥ 60
For previously treated brain tumors, targeted brain therapy (radiation or drug) must have concluded ≥2 months prior to injection of 124I-NM404

Exclusion Criteria:

Life expectancy of < 3 months
Allergy to potassium iodide (SSKI or Thyroshield)
Unwilling or unable to complete 3 separate PET/CT imaging sessions of 90 minutes each over 3 days
Pregnancy or breast-feeding during time of study and/or anticipated breast feeding at any time for 45 days after injection of 124I-NM404.
Intervention: Ethanol
Trial phase: Not Applicable
ATC code: D08AX08 | V03AB16 | V03AZ01
SMILES: CCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: supplements with the proprietary amino acid derivative blend.

Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative
Eligibility criteria:
Inclusion Criteria:

healthy males and healthy females
Between 18 and 70 years

Exclusion Criteria:

Pregnant or nursing
Taking any chronic medication including birth control pills.
Intervention: Sapropterin
Trial phase: Not Applicable
ATC code: A16AX07
SMILES: CC(O)C(O)C1CNc2nc(N)[nH]c(=O)c2N1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).

Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy
Eligibility criteria:
Inclusion Criteria:

Diagnosis of hyperphenylalaninemia at birth
Age between 18 and 50 years
Participated in study HSC-MS-110-0262

Exclusion Criteria:

Peri-menopausal and menopausal women will be excluded because this is a time of increased bone loss related to hormonal mediated factors.
Patients taking bisphosphonates because it alters bone density. Therefore, bone mineral density would reflect the biphosphonate intervention rather than their true status.
Pregnant women due to the hazard of radiation exposure during a DXA scan. In addition women who have been pregnant or who have breastfed within one year of study enrollment will be excluded because these are periods of rapid bone loss which would not reflect the entity under study but would serve to confound the data.
Intervention: Pantoprazole
Trial phase: Phase 2 | Phase 3
ATC code: A02BC02 | A02BD04 | A02BD11
SMILES: COc1ccnc(CS(=O)c2nc3ccc(OC(F)F)cc3[nH]2)c1OC
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 14
Group description: The pantoprazole will be administered in 40mg capsules
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes mellitus
Drug-Naive
No complications
HbA1c 7 to < 9%
Fasting plasma glucose < 210mg/dl
Body mass index 30.0 to 39.9 and body weight stable for at least 3 months before the study
Non smokers
Blood pressure < 130/80

Exclusion Criteria:

Diabetes complications
Women pregnant or stage of lactation
Hepatic, renal, autoimmune disease
Take drugs with effects on insulin secretion
Zollinger-Ellison disease
Gastric or pancreatic tumor.
Intervention: Rifaximin
Trial phase: Not Applicable
ATC code: A07AA11 | D06AX11
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 68
Group description: Rifaximin: 550mg BID for 2 days
Eligibility criteria:
Inclusion Criteria:

Patients undergoing clinically-indicated PET-CT scan for non-GI lymphoma

Exclusion Criteria:

Patients with known Inflammatory Bowel Disease
Patients with known colon cancer
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 367
Group description: ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 14 days.
Eligibility criteria:
Inclusion Criteria:

Are at least 1 years of age and have a clinical diagnosis of active, symptomatic blepharitis
Signature of the subject or parent(s) or legally authorized representative on the Informed Consent Form, and when appropriate the minor's assent in accordance with local regulations
Are willing and able to follow all instructions and attend all study visits (this applies to parent or caregiver for subjects too young to self-apply investigational product)
Are willing to avoid disallowed medication for the duration of the study
If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing (prior to enrollment and at the end of the study) and use effective contraception for the duration of the study
Male subjects whose female partners are not post-menopausal must agree to one of the following: 1) completely abstain from sexual intercourse, 2) use a barrier method (condoms) with spermicide during sexual intercourse for the duration of the study, 3) provide documentation for having had a vasectomy (with documented infertility)
Additional inclusion criteria also apply

Exclusion Criteria:

Have known sensitivity or poor tolerance to any component of the study drugs
Have had eyelid surgery in the study eye within twelve (12) months prior to Visit 1 or plan to have eyelid surgery during the study
Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than blepharitis in the study eye
Have used topical medications on the eyelids or topical ophthalmic corticosteroid medications or systemic use of a corticosteroid mediation within 14 days prior to dosing and/or plan to use them throughout the duration of the study
Be currently pregnant, nursing, or planning a pregnancy; or be a woman who has a positive urine pregnancy test
Have prior (within 30 days prior to dosing) or anticipated concurrent use of an investigational drug or device
Have a condition or a situation which, in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
Additional exclusion criteria also apply
Intervention: Propofol
Trial phase: Not Applicable
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: Subjects recruited into this study will be required to undergo a base MRI scan of the brain. On a separate day propofol will be administered with concurrent EEG while subjects respond to stimuli.

Propofol: Propofol will be infused using a computer controlled delivery system running the program STANPUMP. Loss of consciousness will be defined as loss of response to auditory stimulus (button press).
Eligibility criteria:
Inclusion Criteria:

Healthy, non-smoking male and female volunteers, ages 18-36 with normal body weight.
American Society of Anesthesiologists (ASA) physical status I

Exclusion Criteria:

History of head trauma
Surgical aneurysm clips
Cardiac pacemaker
Prosthetic heart valve
Neurostimulator
Implanted pumps
Cochlear implants
Metal rods, plates
Screws
Intrauterine device
Hearing aid
Dentures (which might create NMR artifacts)
Metal injury to eyes
Intervention: Celecoxib
Trial phase: Phase 3
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 93
Group description: Celecoxib : 200 mg capsules
Eligibility criteria:
Inclusion Criteria:

Patient is male or female between 18 and 65 years of age
For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures
Patient must be willing to stay at the study site ≥ 72 hours

Exclusion Criteria:

Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
Patient has a current disease or history of a disease that will impact the study or the patient's well-being
Patient has used or intends to use any of the medications that are prohibited by the protocol
Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
Patient has taken another investigational drug within 30 days prior to screening
Intervention: Indomethacin
Trial phase: Phase 3
ATC code: C01EB03 | M01AB01 | M01AB51 | M02AA23 | S01BC01 | S01CC02
SMILES: COc1ccc2c(c1)c(CC(=O)O)c(C)n2C(=O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 91
Group description: Indomethacin : 20 mg TID capsules
Eligibility criteria:
Inclusion Criteria:

Patient is male or female between 18 and 65 years of age
For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures
Patient must be willing to stay at the study site ≥ 72 hours

Exclusion Criteria:

Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
Patient has a current disease or history of a disease that will impact the study or the patient's well-being
Patient has used or intends to use any of the medications that are prohibited by the protocol
Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
Patient has taken another investigational drug within 30 days prior to screening
Intervention: Indomethacin
Trial phase: Phase 3
ATC code: C01EB03 | M01AB01 | M01AB51 | M02AA23 | S01BC01 | S01CC02
SMILES: COc1ccc2c(c1)c(CC(=O)O)c(C)n2C(=O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 91
Group description: Indomethacin : 40 mg BID capsules
Eligibility criteria:
Inclusion Criteria:

Patient is male or female between 18 and 65 years of age
For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures
Patient must be willing to stay at the study site ≥ 72 hours

Exclusion Criteria:

Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
Patient has a current disease or history of a disease that will impact the study or the patient's well-being
Patient has used or intends to use any of the medications that are prohibited by the protocol
Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
Patient has taken another investigational drug within 30 days prior to screening
Intervention: Indomethacin
Trial phase: Phase 3
ATC code: C01EB03 | M01AB01 | M01AB51 | M02AA23 | S01BC01 | S01CC02
SMILES: COc1ccc2c(c1)c(CC(=O)O)c(C)n2C(=O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 93
Group description: Indomethacin : 40 mg TID capsules
Eligibility criteria:
Inclusion Criteria:

Patient is male or female between 18 and 65 years of age
For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures
Patient must be willing to stay at the study site ≥ 72 hours

Exclusion Criteria:

Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
Patient has a current disease or history of a disease that will impact the study or the patient's well-being
Patient has used or intends to use any of the medications that are prohibited by the protocol
Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
Patient has taken another investigational drug within 30 days prior to screening
Intervention: Indacaterol
Trial phase: Phase 4
ATC code: R03AC18 | R03AK14 | R03AL04 | R03AL12
SMILES: CCc1cc2c(cc1CC)CC(NC[C@H](O)c1ccc(O)c3[nH]c(=O)ccc13)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI).
Eligibility criteria:
Inclusion Criteria:

Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening

Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2008) and:

Smoking history of at least 10 pack-years
Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 70% and ≥ 40% of the predicted normal value
Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
Breathing symptoms that interfere with daily activities

Exclusion Criteria:

Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening
Patients who have had a respiratory tract infection within 6 weeks prior to screening
Patients who require oxygen therapy for chronic hypoxemia, are receiving bronchodilators or other medications for COPD that are dosed once daily, are unable to follow instruction on rescue albuterol use during the study, or are at risk deterioration of COPD with study procedures. Patients with concomitant pulmonary disease
Patients with a history of asthma
Patients with uncontrolled diabetes mellitus
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular co-morbid conditions

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Gadobutrol
Trial phase: Phase 1
ATC code: V08CA09
SMILES: O=C([O-])CN1CCN(CC(=O)[O-])CCN(C(CO)C(O)CO)CCN(CC(=O)[O-])CC1.[Gd+3]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 44
Group description: Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
Eligibility criteria:
Inclusion Criteria:

Pediatric subjects aged <2 years (term newborn infants to toddlers 23 months of age inclusive)
Subject is scheduled to undergo routine gadolinium-enhanced MRI of any body region

Exclusion Criteria:

Subjects undergoing a change in chemotherapy within 48 hours prior to and up to 24 hours after gadobutrol injection
Any planned intervention during the study and up to 24 hours after gadobutrol injection (excluding lumbar puncture)
Subjects who received or will receive any investigational product within 48 hours before gadobutrol injection or during study participation
Subjects who received or will receive any other contrast agent within 48 hours prior to gadobutrol injection or up to 24 hours after gadobutrol injection
Subjects with contraindication for MRI such as iron metal implants (e.g. aneurysm clips)
History of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents
Subject with renal insufficiency of any intensity, i.e. estimated Glomerular Filtration Rate <80% of age adjusted normal value calculated based on the Schwartz formula