anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Levetiracetam
Trial phase: Phase 4
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose
Eligibility criteria:
Inclusion Criteria:

Healthy subjects with normal renal function
Subject is Japanese
Subjects with creatinine clearance within 1 of 3 Groups (CLcr[mL/min/1.73 cm^2]: Group B: 50 - <80, Group C: 30 - <50, Group D: <30), or for Group E, subjects with end-stage renal failure undergoing hemodialysis

Exclusion Criteria:

Subjects has taken any drug treatment, disease or injury to influence Levetiracetam PK except for renal impairments
Intervention: Levetiracetam
Trial phase: Phase 4
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose
Eligibility criteria:
Inclusion Criteria:

Healthy subjects with normal renal function
Subject is Japanese
Subjects with creatinine clearance within 1 of 3 Groups (CLcr[mL/min/1.73 cm^2]: Group B: 50 - <80, Group C: 30 - <50, Group D: <30), or for Group E, subjects with end-stage renal failure undergoing hemodialysis

Exclusion Criteria:

Subjects has taken any drug treatment, disease or injury to influence Levetiracetam PK except for renal impairments
Intervention: Levetiracetam
Trial phase: Phase 4
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose
Eligibility criteria:
Inclusion Criteria:

Healthy subjects with normal renal function
Subject is Japanese
Subjects with creatinine clearance within 1 of 3 Groups (CLcr[mL/min/1.73 cm^2]: Group B: 50 - <80, Group C: 30 - <50, Group D: <30), or for Group E, subjects with end-stage renal failure undergoing hemodialysis

Exclusion Criteria:

Subjects has taken any drug treatment, disease or injury to influence Levetiracetam PK except for renal impairments
Intervention: Levetiracetam
Trial phase: Phase 4
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.

Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose
Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Eligibility criteria:
Inclusion Criteria:

Healthy subjects with normal renal function
Subject is Japanese
Subjects with creatinine clearance within 1 of 3 Groups (CLcr[mL/min/1.73 cm^2]: Group B: 50 - <80, Group C: 30 - <50, Group D: <30), or for Group E, subjects with end-stage renal failure undergoing hemodialysis

Exclusion Criteria:

Subjects has taken any drug treatment, disease or injury to influence Levetiracetam PK except for renal impairments
Intervention: Lisinopril
Trial phase: Phase 1
ATC code: C09AA03 | C09BA03 | C09BB03 | C10BX07
SMILES: NCCCC[C@H](N[C@@H](CCc1ccccc1)C(=O)O)C(=O)N1CCC[C@H]1C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 8
Group description: Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
Eligibility criteria:
Inclusion Criteria:

Kidney transplant recipient
Age 2-17 years, inclusive, at the time of first study dose
Estimated GFR (eGFR) ≥30 ml/min/1.73m2, with stable allograft function as indicated by <20% change in serum creatinine in the previous 30 days
Stable immunosuppressive regimen, as indicated by <10% change in dosage (in mg/kg) in these medications, within the 14 days prior to enrollment
Systolic BP >90th percentile for age, gender, and height, necessitating initiation or addition of an antihypertensive medication
For females of child-bearing potential, a negative serum pregnancy test prior to initial dosing and agreement to practice appropriate contraceptive measures, including abstinence, from the time of the initial pregnancy testing through the remainder of the study (30 days after last administration of investigational agents).

Exclusion Criteria:

History of anaphylaxis attributable to lisinopril or other angiotensin-converting enzyme inhibitor (ACEI) agents (e.g.,enalapril, ramipril, quinapril)
History of anaphylaxis attributable to iohexol or an iodine hypersensitivity
Use of an angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker, or renin antagonist within 30 days prior to enrollment
Stage 2 hypertension defined as the >99th percentile for age, height and gender + 5 mm Hg
Blood Potassium value > 6.0 milliequivalent / liter (mEq/L) (as determined at the screening visit)
Previous participation in this study
Physician concern that the participant may not adhere to the study protocol, based on prior behavior
Current plasmapheresis treatment
History of angioedema
Pregnancy
Intervention: Lisinopril
Trial phase: Phase 1
ATC code: C09AA03 | C09BA03 | C09BB03 | C10BX07
SMILES: NCCCC[C@H](N[C@@H](CCc1ccccc1)C(=O)O)C(=O)N1CCC[C@H]1C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 2
Group description: Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
Eligibility criteria:
Inclusion Criteria:

Kidney transplant recipient
Age 2-17 years, inclusive, at the time of first study dose
Estimated GFR (eGFR) ≥30 ml/min/1.73m2, with stable allograft function as indicated by <20% change in serum creatinine in the previous 30 days
Stable immunosuppressive regimen, as indicated by <10% change in dosage (in mg/kg) in these medications, within the 14 days prior to enrollment
Systolic BP >90th percentile for age, gender, and height, necessitating initiation or addition of an antihypertensive medication
For females of child-bearing potential, a negative serum pregnancy test prior to initial dosing and agreement to practice appropriate contraceptive measures, including abstinence, from the time of the initial pregnancy testing through the remainder of the study (30 days after last administration of investigational agents).

Exclusion Criteria:

History of anaphylaxis attributable to lisinopril or other angiotensin-converting enzyme inhibitor (ACEI) agents (e.g.,enalapril, ramipril, quinapril)
History of anaphylaxis attributable to iohexol or an iodine hypersensitivity
Use of an angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker, or renin antagonist within 30 days prior to enrollment
Stage 2 hypertension defined as the >99th percentile for age, height and gender + 5 mm Hg
Blood Potassium value > 6.0 milliequivalent / liter (mEq/L) (as determined at the screening visit)
Previous participation in this study
Physician concern that the participant may not adhere to the study protocol, based on prior behavior
Current plasmapheresis treatment
History of angioedema
Pregnancy
Intervention: Rebamipide
Trial phase: Phase 2
ATC code: A02BX14
SMILES: O=C(NC(Cc1cc(=O)[nH]c2ccccc12)C(=O)O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: OPC-12759 ophthalmic suspension 2%
Eligibility criteria:
Inclusion Criteria:

Diagnosis of superficial punctate keratopathy, corneal erosion or persistent epithelial defect
Fluorescein corneal staining score of 3 or higher

Exclusion Criteria:

Active ocular infection
Vernal keratoconjunctivitis
Recurrent corneal erosion
Physical irritation of eyelashes or relaxed bulbar conjunctiva to cornea or conjunctiva
Subjects who cannot discontinue or anticipate use of eye drops except for limited concomitant ones during the study. Soft-santear is allowed during the screening period.
Anticipated use of contact lens during the study.
Insertion of punctal plug or fall out of punctal plug within 3 months
Subjects who are judged by the investigator to be ineligible for the study because of a past or concurrent systemic disease.
Receipt of any investigational product within 4 months.
Intervention: Travoprost
Trial phase: Phase 4
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 199
Group description: Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks

Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye.
Be on either latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy (including BAK-containing generics) for at least four weeks prior to Screening visit.
Would benefit from a switch to TRAVATAN® Solution without BAK containing Polyquad® Preservative due to tolerability issues, in the opinion of the investigator.
IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that assured clinical stability of vision and the optic nerve throughout the study period.
Willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study deemed clinically significant in the opinion of the Principal Investigator.
Any abnormality preventing reliable applanation tonometry in either eye.
Severe dry eye or related which has been or currently is being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
Any clinically significant, serious, or severe medical condition.
Intraocular conventional surgery or laser surgery in either eye less than three months prior to Screening Visit.
Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
Progressive retinal or optic nerve disease from any cause.
Women who are pregnant, lactating.
Women not using reliable means of birth control.
Use of any systemic medication known to affect IOP which has not been on stable course for at least 7 days prior to Screening Visit.
Any clinically significant, serious, or severe medical condition.
Participation in any other investigational study within 30 days of Screening Visit.
Other protocol-defined exclusion criteria may apply.
Intervention: DCFBC F-18
Trial phase: Phase 1 | Phase 2
SMILES: O=C(O)CC[C@H](NC(=O)N[C@@H](CSCc1ccc([18F])cc1)C(=O)O)C(=O)O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Patients will be imaged with 18F-DCFBC

18F-DCFBC: A bolus of 10 mCi (370 MBq) [9-11 mCi (333-407 MBq)] of 18F-DCFBC will be injected into the IV line by slow IV push.
Eligibility criteria:
Inclusion Criteria:

Newly diagnosed prostate cancer pathologically proven by prostate biopsy
Prostate biopsy histology grade ≥ Gleason 3+3=6.
Patients considered as candidates for and medically fit to undergo prostatectomy
At least 10 days after most recent prostate biopsy
No known problems with peripheral IV or central line access
Able to tolerate urinary straight catheter placement
Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.
Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.

Exclusion Criteria:

Prior pelvic external beam radiation therapy or brachytherapy
Chemotherapy for prostate cancer
Hormone deprivation therapy
Investigational therapy for prostate cancer
Hemorrhagic cystitis or active prostatitis
Unable to lie flat during or tolerate PET/CT
Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer
No prostatectomy scheduled prior to follow-up visit (12 to 72 hours post imaging)
Serum creatinine > 1.5 mg/dL or creatinine clearance < 50 mL/min/1.73m2
Intervention: Levetiracetam
Trial phase: Phase 4
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 173
Group description: Levetiracetam twice a day treatment Group

250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Male or female subjects from 16 to 80 years, inclusive. Vulnerable subjects (e.g., under 20 years or subject with learning disability but judged to be capable to understand) may only be included where legally permitted and ethically accepted
Subjects with newly or recently diagnosed epilepsy having experienced unprovoked partial seizures (IA, IB, IC with clear focal origin), that are classifiable according to the International Classification of Epileptic seizure (1981). Undiscriminated subjects between IC and IIE could be included
Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year preceding randomization out of which at least 1 unprovoked seizure in the 6 months preceding randomization
Subjects with documented evidence of EEG and brain MRI or CT scan in medical records which were performed within 1 year prior to Visit 1 (V1)
Subjects have no treatment with anti-epileptic drugs in the 6 months preceding this study. The treatment for acute seizure control is acceptable with a maximum of 2 weeks duration and if the treatment was stopped at least 1 week before V1. For Phenobarbital and Phenobarbital derivatives, a minimum of 4 weeks wash-out is requested before V1

Exclusion Criteria:

Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events which could be confused with seizures
Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: neuroleptics, monoamine oxidase (MAO) inhibitors and narcotic analgesics
Subject taking any immunosuppressant within 28 days prior to Visit 1
Subject has a history of suicide attempt, has received professional counseling for suicidal ideation, or is currently experiencing active suicidal ideation
Subject has a seizure disorder characterized primarily by isolated auras (ie, simple partial seizures without observable motor signs)
Subject suffering from seizures other than partial (IA, IB, IC, with clear focal origin) seizures
Subject has a history of status epilepticus within last 3-month period prior to Visit 1
Subject has seizures that are uncountable due to clustering (ie, an episode lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished) during the 12-week period prior to Visit 1 and/or during the Screening Period
Body weight is lower than 40 kg (< 40 kg)
Intervention: Fingolimod Hydrochloride
Trial phase: Phase 4
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1.Cl
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 200
Group description: Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Eligibility criteria:
Inclusion Criteria:

Patients diagnosed with multiple sclerosis, according to the 2010 revised McDonald criteria, with a relapsing-remitting course, and with at least 9 T2 lesions consistent with the disease, with disease duration greater than or equal to one year and less than or equal to five years.
Patients who have had at least two relapses in the past two years and an Expanded Disability Status Scale score between 0 and 3.5, inclusive.

Patients

Treatment naïve: patients who have never been treated with a Disease Modifying Therapy or
Previously treated with a first-line Disease Modifying Therapy

Exclusion Criteria:

Patients who have received treatment with:

Fingolimod at any time (e.g. participation in a fingolimod clinical trial), Immunosuppressant drugs such as azathioprine or methotrexate at any time; Immunoglobulins in the past 6 months. Monoclonal antibodies including natalizumab, Cladribine, cyclophosphamide or mitoxantrone, at any time.

- Other protocol defined inclusion/exclusion criteria may apply
Intervention: Fingolimod Hydrochloride
Trial phase: Phase 4
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1.Cl
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 147
Group description: Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.
Eligibility criteria:
Inclusion Criteria:

Patients diagnosed with multiple sclerosis, according to the 2010 revised McDonald criteria, with a relapsing-remitting course, and with at least 9 T2 lesions consistent with the disease, with disease duration greater than or equal to one year and less than or equal to five years.
Patients who have had at least two relapses in the past two years and an Expanded Disability Status Scale score between 0 and 3.5, inclusive.

Patients

Treatment naïve: patients who have never been treated with a Disease Modifying Therapy or
Previously treated with a first-line Disease Modifying Therapy

Exclusion Criteria:

Patients who have received treatment with:

Fingolimod at any time (e.g. participation in a fingolimod clinical trial), Immunosuppressant drugs such as azathioprine or methotrexate at any time; Immunoglobulins in the past 6 months. Monoclonal antibodies including natalizumab, Cladribine, cyclophosphamide or mitoxantrone, at any time.

- Other protocol defined inclusion/exclusion criteria may apply
Intervention: Desogestrel
Trial phase: Phase 2
ATC code: G03AA09 | G03AB05 | G03AC09 | G03FB10
SMILES: [H][C@@]12CC[C@@](O)(C#C)[C@@]1(CC)CC(=C)[C@@]1([H])[C@@]2([H])CCC2=CCCC[C@@]21[H]
Sex: Female
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 1
Group description: open label studied on drug.

Desogestrel: Reclipsen oral contraceptive pill with 0.03mg ethinyl estradiol and 0.15mg desogestrel
Eligibility criteria:
Inclusion Criteria:

diagnosed congenital central hypoventilation syndrome (CCHS)
female
greater than or equal to 16 years of age

Exclusion Criteria:

less than 16 years of age
male
pregnant
poor adherence to medications
inability to perform pulmonary maneuvers for tests
contraindications to oral contraceptives
pulmonary hypertension
Intervention: Maltose
Trial phase: Phase 2
SMILES: OCC1OC(OC2C(CO)OC(O)C(O)C2O)C(O)C(O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 195
Group description: This group received matching lactose powder filled capsules on days 1-7.
Eligibility criteria:
Inclusion Criteria:

Adult patients (age > 18) admitted to the hospital through the emergency department (ED)
At high risk of developing acute lung injury (ALI) Lung Injury Prediction Score (LIPS) greater than or equal to 4

Exclusion Criteria:

Anti-platelet therapy on admission or within 7 days prior to admission
Presented to outside hospital ED > 12 hrs before arrival at site's facility
Inability to obtain consent within 12 hours of hospital presentation
Admitted for elective surgery
Acute lung injury prior to randomization
Receiving mechanical ventilation through a tracheostomy tube prior to current hospital admission (patient who is ventilator dependent)
Presence of bilateral pulmonary infiltrates on admission if he or she has a history of bilateral pulmonary infiltrates (as evidenced by previous x-rays) that can reasonably explain the current degree of pulmonary infiltrates present.
Presentation due to pure heart failure and no other known risk factors for ALI.
Allergy to aspirin or non steroidal anti inflammatory drugs (NSAIDs)
Bleeding disorder
Suspected active bleeding or judged to be at high risk for bleeding
Active peptic ulcer disease (within past 6 months)
Severe chronic liver disease
Inability to administer the study drug
Expected hospital stay < 48 hours
Admitted for comfort or hospice care
Patient, surrogate or physician not committed to full support. (Exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
Not anticipated to survive > 48 hours
Previously enrolled in this trial
Enrolled in a concomitant intervention trial
Pregnant or breastfeeding
Intervention: Dexmedetomidine
Trial phase: Phase 2
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 24
Group description: Dexmedetomidine: after inhalational induction with 6% in sevoflurane in O2:N2O (30:70),administer dexmedetomidine at 2 mcg/kg over 10min followed by an infusion of dexmedetomidine at 3mcg/kg/hr and image the upper airway when expired sevoflurane in 0
Eligibility criteria:
Inclusion Criteria:

Children undergoing MRI brain
Age 2 - 5 yrs
ASA I - II

Exclusion Criteria:

OSA
Pathology of upper airway
Craniofacial anomalies
Gastroesophageal reflux
Increased intracranial pressure
Body weight of 20% more than ideal
Contraindication to the use of either drug
Failure to maintain a patent airway during the study