anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Dapagliflozin
Trial phase: Phase 1
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 8
Group description: Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of T2DM
Male and female subjects ages 10-17
Glycosylated Hemoglobin A1c (HbA1c) ≥6 to 10%
Body weight ≥30 kg

Exclusion Criteria:

Fasting plasma glucose (FPG) >240 mg/dL at screening
Abnormal renal function
Active liver disease and/or significant abnormal liver function
Intervention: Fluorouracil
Trial phase: Phase 3
ATC code: L01BC02 | L01BC52
SMILES: O=c1[nH]cc(F)c(=O)[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Patients who have undergone kidney or liver transplant within 2 years and have at least 4 premalignant skin lesions on the face, ears, scalp, forearms and/or dorsal hands.
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age
At least four (4) actinic keratoses, located on face, ears, scalp, forearms and/or dorsal hands. - Patients in the solid organ transplant arm of the study must have had either a kidney or liver transplant, and the transplantation surgery must have occurred at least 2 years prior to enrollment.

Exclusion Criteria:

Pregnant or nursing
Currently participating in another clinical trial
Using any topical treatment for their actinic keratoses
Currently being treated for other cancers with medical or radiation therapy
Patients with a known hypersensitivity to 5-aminolevulinic acid, 5-fluorouracil or any component of the study material
Patients with a history of a photosensitivity disease, including porphyria cutanea tarda
Intervention: Fluorouracil
Trial phase: Phase 3
ATC code: L01BC02 | L01BC52
SMILES: O=c1[nH]cc(F)c(=O)[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Patients with at least 4 actinic keratoses on the face, ears, scalp, forearms and/or dorsal hands.
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age
At least four (4) actinic keratoses, located on face, ears, scalp, forearms and/or dorsal hands. - Patients in the solid organ transplant arm of the study must have had either a kidney or liver transplant, and the transplantation surgery must have occurred at least 2 years prior to enrollment.

Exclusion Criteria:

Pregnant or nursing
Currently participating in another clinical trial
Using any topical treatment for their actinic keratoses
Currently being treated for other cancers with medical or radiation therapy
Patients with a known hypersensitivity to 5-aminolevulinic acid, 5-fluorouracil or any component of the study material
Patients with a history of a photosensitivity disease, including porphyria cutanea tarda
Intervention: MAGNESIUM OXIDE
Trial phase: Phase 2
ATC code: A02AA02 | A06AD02 | A12CC10
SMILES: O=[Mg]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Magnesium oxide capsules 800mg twice daily (total of 1000mg of elemental magnesium) for year 1. Upon completion of the first year, barring any safety concerns, all subjects were administered 2500 mg magnesium oxide (total of 1500 mg elemental magnesium) daily for up to one additional year. Subjects received 600 mg elemental magnesium oxide in the morning (taken as two 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium) and 900 mg elemental magnesium oxide in the evening (taken as three 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium).
Eligibility criteria:
Inclusion Criteria:

Male or female subject at least 18 years of age
If female, the subject is not pregnant or nursing
If female of child bearing potential, the subject has a negative urine pregnancy test at the first visit, and agrees to use an approved method of contraception (hormonal contraceptives [birth control pills, implants [Norplant] or injections [DepoProvera]); intrauterine device (IUD); two forms of barrier methods [condoms and diaphragm]; or abstinence (no sexual activity) throughout the entire study
Biopsy confirmed diagnosis of pseudoxanthoma elasticum (documenting some calcification of elastic fibers)
Subject has a clinical disease severity grade of at least "1" (Poorly defined, barely visible macules) at screening.
Normal kidney function tests

Exclusion Criteria:

Any subject who is pregnant or becomes pregnant during the study
Subjects with a serum creatinine greater than 1.6 mg/dL
Subjects with hypermagnesemia, hypokalemia, or idiopathic hypercalciuria
Subjects with kidney disease or renal tubular defects (eg. Fanconi's syndrome), or on dialysis
Subjects with hypothyroidism or hypoparathyroidism or primary hyperparathyroidism
Subjects with acute gout
Subjects with malabsorption, or osteomalacia
Subjects on diuretics, magnesium containing antacids, or anabolic steroids
Subjects with Cushing's syndrome
Subjects receiving lithium and those with significant psychiatric disorders that would likely interfere with participation in this study
Subjects taking anti-seizures medications and anti-arrhythmics medications
Subjects on tetracycline or metronidazole and ace inhibitors
Subjects taking cyclosporine or calcineurin inhibitors
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 19
Group description: Placebo
Eligibility criteria:
Inclusion Criteria:

5 to 12 years old
pathogenic deletions or mutations of the SHANK3 gene
stable medication regimens for at least three months prior to enrollment

Exclusion Criteria:

closed epiphyses
active or suspected neoplasia
intracranial hypertension
hepatic insufficiency
renal insufficiency
cardiomegaly / valvulopathy
history of allergy to IGF-1 or any component of the formulation (mecasermin)
history of extreme prematurity (<1000 grams) with associated early neo-natal complications, e.g. intra-cerebral hemorrhage, prolonged hypoxia, prolonged hypoglycemia
patients with comorbid conditions deemed too medically compromised to tolerate the risk of experimental treatment with IGF-1
Intervention: Famciclovir
Trial phase: Phase 3
ATC code: J05AB09 | S01AD07
SMILES: CC(=O)OCC(CCn1cnc2cnc(N)nc21)COC(C)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Treatment with 3 months of active drug

Famciclovir: Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months on drug).
Eligibility criteria:
Inclusion Criteria:

Unilateral Meniere's Disease
2 vertigo episodes of at least 20 minutes
Fluctuating hearing by subjective history and/or audiometric documentation. Audiometric documentation is defined as affected ear pure-tone average change from an audiogram at Time 1 to Time 2 (less than one year apart) of greater than 15 dB.
Less than 45 dB 4-frequency pure-tone average in the affected ear
Tinnitus and/or aural fullness
Willing to undergo the clinical trial procedures
Signed informed consent

Exclusion Criteria:

Acute or chronic middle ear disease in either ear
Only hearing ear
4-frequency pure-tone average > 45 dB in either ear
Known allergy to famciclovir or any of the ingredients in the formulation
Taking oral steroids or receiving IT steroids at time of enrollment. If the subject has been on oral steroids/IT steroids, 3 months must elapse from last dose to start of treatment in the study
Must not have had previous inner ear surgery
History of immunodeficiency diseases such as HIV
History of renal insufficiency or other kidney diseases
A female of child-bearing potential who is pregnant
History of noncompliance to medical regimens
Unwilling to or unable to comply with the protocol, including scheduling study evaluations
Intervention: Ticagrelor
Trial phase: Phase 1
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Active comparator
Eligibility criteria:
Inclusion Criteria:

Healthy male subjects between the ages of 20 and 50 years at screening
Subjects with Body Mass Index (BMI) between 18.0 (inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). BMI (kg/m2) = body weight (kg)/ {height (m)}2.
Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures.
Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the laboratory reference ranges for the relevant laboratory tests
Intervention: Midazolam
Trial phase: Phase 3
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 161
Group description: USL261 5 mg or USL261 5 mg + 5 mg for a treated seizure cluster episode
Eligibility criteria:
Inclusion Criteria:

Has a competent, adult caregiver who can recognize and observe the subject's seizure cluster episodes
Has successfully completed study P261-401, and the subject and caregiver have demonstrated adequate compliance with P261-401 study procedures as determined by the investigator

Exclusion Criteria:

Has experienced status epilepticus during or since the P261-401 study
In the opinion of the investigator, is experiencing an ongoing, uncontrolled, clinically significant adverse event(s) from P261-401 at Visit 1 or did experience a clinically significant adverse event in study P261-401 that might prevent the subject from safely participating in the study
Has a neurological disorder that is likely to progress in the next year
Has a history of acute narrow-angle glaucoma
Has a medical condition including uncontrolled cardiac, pulmonary, renal, hepatic, or gastrointestinal disease that could interfere with the study, subject safety/safety monitoring, or is not stable despite current therapy
Subject has severe chronic cardio-respiratory disease or the need for ambulatory oxygen
Has had psychogenic, non-epileptic seizure(s) during or since the P261-401 study
Has active suicidal plan or intent as determined by the C-SSRS at Visit 1 or medical history
Subject has had vagus nerve stimulator (VNS) implanted since the completion of study P261-401
Intervention: Phenylbutyric acid
Trial phase: Phase 2 | Phase 3
ATC code: A16AX03
SMILES: O=C(O)CCCc1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Study Drug

Phenylbutyrate: Dosage of phenylbutyrate powder will be 500 mg/kg/day in patients weighing less than 20kg and 10 g/m2/day in larger patients in four divided doses per day, the standard UCD dose studied in our preliminary studies, for 14 days.
Eligibility criteria:
Inclusion Criteria:

Must be 3 years or older at enrollment.
Must have a diagnosis of maple syrup urine disease (MSUD) confirmed by the presence of plasma alloisoleucine (>5 micromol/L) and/or genetic testing showing mutations in both alleles of any subunit of BCKDHA (E1alpha subunit gene, MSUD type 1A), BCKDHB (E1beta subunit gene, MSUD type 1B), or DBT (E2 subunit gene, MSUD type 2).
Participants must have a history of compliance to diet and treatment.
Signed informed consent by subject and/or subject's legally acceptable representative.
Must be capable of completing study procedures, including taking oral or G- tube medication.
Negative pregnancy test for all females of childbearing potential.
All females of childbearing potential and all sexually active males must agree to use an acceptable method of contraception throughout the study. Appropriate contraceptive methods include hormonal contraceptives (oral, injected, implanted, or transdermal), tubal ligation, intrauterine device, hysterectomy, vasectomy, or double barrier methods. Abstinence is an acceptable form of birth control, though appropriate contraception must be used if the subject becomes sexually active.

Exclusion Criteria:

May not have used sodium phenylbutyrate within 30 days of Visit 1.
May not have an active infection (viral or bacterial) or any condition which may exacerbate their MSUD causing metabolic decompensation.
Cannot have any clinical or laboratory abnormality of Grade 3 or greater according to the Common Terminology Criteria for Adverse Events v3.0 (CTCAE) (or for conditions not covered by the CTCAE, a severe or life-threatening toxicity).
May not have taken any medications known to significantly affect renal clearance or to increase protein catabolism within the 24 hours prior to Visit 1.
May not participate if they have a known hypersensitivity to phenylacetate or phenylbutyrate or creatinine levels 1.5 times or more ULN.
Since a total of 53 mL will be drawn over Days 14 and 15 of both treatment periods, only subjects weighing more than 30 pounds can be enrolled.
Intervention: Terazosin
Trial phase: Phase 2 | Phase 3
ATC code: G04CA03
SMILES: COc1cc2nc(N3CCN(C(=O)C4CCCO4)CC3)nc(N)c2cc1OC
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Terazosin: 2 mg BID
Eligibility criteria:
Inclusion Criteria:

If a patient does not meet any exclusion criteria and to be undergone double-J stent indwelling.

Exclusion Criteria:

Prior history of pelvic surgery
Prior history of Transurethral Resection of the either Prostate or Bladder Tumor
Benign prostate hyperplasia
Recent or recurrent urinary tract infection
Chronic medication with beta-blockers or Anti-cholinergic
Pregnancy
Prostatitis
Prostate cancer
Bilateral ureteroscopy or ureteral stenting
Age < 18 and > 55
Stone size > 20 mm
Diabetes
Bladder Outlet Obstruction
Intervention: Tolterodine
Trial phase: Phase 2 | Phase 3
ATC code: G04BD07
SMILES: Cc1ccc(O)c([C@H](CCN(C(C)C)C(C)C)c2ccccc2)c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Tolterodine: 2 mg daily
Eligibility criteria:
Inclusion Criteria:

If a patient does not meet any exclusion criteria and to be undergone double-J stent indwelling.

Exclusion Criteria:

Prior history of pelvic surgery
Prior history of Transurethral Resection of the either Prostate or Bladder Tumor
Benign prostate hyperplasia
Recent or recurrent urinary tract infection
Chronic medication with beta-blockers or Anti-cholinergic
Pregnancy
Prostatitis
Prostate cancer
Bilateral ureteroscopy or ureteral stenting
Age < 18 and > 55
Stone size > 20 mm
Diabetes
Bladder Outlet Obstruction
Intervention: Tranexamic acid
Trial phase: Phase 2
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
Eligibility criteria:
Inclusion Criteria:

For Stage 1: Planned primary isolated CABG surgery
For Stage 2: Planned primary isolated CABG surgery, OR Planned primary combined CABG and aortic valve replacement surgery
Men, aged 18 to 85 years, or Women, aged 18 to 85 years, either of postmenopausal status, defined as ≥1 year since last menstrual period AND if less than 65 years old with a negative pre-operative pregnancy test within 24 hours of surgery OR with medical history of hysterectomy or bilateral oophorectomy
Written informed consent

Exclusion Criteria:

Off-pump surgery or hybrid procedures
Patients undergoing repeat sternotomy
Planned deep hypothermic circulatory arrest (<28°C)
Known allergy, sensitivity, or contraindications to tranexamic acid
Epileptiform disorders, history of seizure activity, or anticonvulsive medication
Administration of clopidogrel, ticagrelor or ticlopidine within 5 days prior to surgery or prasugrel within 7 days prior to surgery.
Administration of low molecular weight heparin, glycoprotein IIb/IIIa inhibitors, or fondaparinux within 12 hours prior to surgery
Known history of coronary stent thrombosis within the last three months
History of stroke or transient ischemic attack within 3 months prior to surgery
History of deep venous thrombosis or pulmonary embolism
LVEF ≤35% or Grade III or IV
Body mass index <20 or >35
Known active gastrointestinal (GI) or other non-catheterization bleeding within 7 days prior to surgery
Preoperative coagulation abnormalities defined as:
Platelet count <100,000/L or >350,000/L, or
International normalized ration (INR) >1.5, or
Hematocrit <36%, or
aPTT >1.5 x ULN
Major surgical procedures within 30 days prior to surgery
Patient inability or refusal to receive donor blood products if necessary
Creatinine >2 mg/dL or estimated glomerular filtration rate (eGFR) (calculated using Modification of Diet in Renal Disease [MDRD] equation <30 mL/min)
Known heparin-induced thrombocytopenia type II
Known history of thrombophilia, such as AT-III, Protein C or Protein S deficiency, Factor V Leiden, anti-phospholipid syndrome
Active liver disease defined as any known current infectious, neoplastic or metabolic pathology of the liver OR ALT or AST elevation >2x ULN or total bilirubin elevation >1.5x ULN at Screening
Any condition requiring ongoing chronic immunosuppressive medication
Malignancy within 5 years prior to surgery
Receipt of an investigational drug or device within 60 days prior to surgery Any other condition which, in the opinion of the Principal Investigator, would put the subject at increased risk from participating in the study or otherwise prevent a patient"s participation in the study
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: 6
Group description: saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
Eligibility criteria:
Inclusion Criteria:

For Stage 1: Planned primary isolated CABG surgery
For Stage 2: Planned primary isolated CABG surgery, OR Planned primary combined CABG and aortic valve replacement surgery
Men, aged 18 to 85 years, or Women, aged 18 to 85 years, either of postmenopausal status, defined as ≥1 year since last menstrual period AND if less than 65 years old with a negative pre-operative pregnancy test within 24 hours of surgery OR with medical history of hysterectomy or bilateral oophorectomy
Written informed consent

Exclusion Criteria:

Off-pump surgery or hybrid procedures
Patients undergoing repeat sternotomy
Planned deep hypothermic circulatory arrest (<28°C)
Known allergy, sensitivity, or contraindications to tranexamic acid
Epileptiform disorders, history of seizure activity, or anticonvulsive medication
Administration of clopidogrel, ticagrelor or ticlopidine within 5 days prior to surgery or prasugrel within 7 days prior to surgery.
Administration of low molecular weight heparin, glycoprotein IIb/IIIa inhibitors, or fondaparinux within 12 hours prior to surgery
Known history of coronary stent thrombosis within the last three months
History of stroke or transient ischemic attack within 3 months prior to surgery
History of deep venous thrombosis or pulmonary embolism
LVEF ≤35% or Grade III or IV
Body mass index <20 or >35
Known active gastrointestinal (GI) or other non-catheterization bleeding within 7 days prior to surgery
Preoperative coagulation abnormalities defined as:
Platelet count <100,000/L or >350,000/L, or
International normalized ration (INR) >1.5, or
Hematocrit <36%, or
aPTT >1.5 x ULN
Major surgical procedures within 30 days prior to surgery
Patient inability or refusal to receive donor blood products if necessary
Creatinine >2 mg/dL or estimated glomerular filtration rate (eGFR) (calculated using Modification of Diet in Renal Disease [MDRD] equation <30 mL/min)
Known heparin-induced thrombocytopenia type II
Known history of thrombophilia, such as AT-III, Protein C or Protein S deficiency, Factor V Leiden, anti-phospholipid syndrome
Active liver disease defined as any known current infectious, neoplastic or metabolic pathology of the liver OR ALT or AST elevation >2x ULN or total bilirubin elevation >1.5x ULN at Screening
Any condition requiring ongoing chronic immunosuppressive medication
Malignancy within 5 years prior to surgery
Receipt of an investigational drug or device within 60 days prior to surgery Any other condition which, in the opinion of the Principal Investigator, would put the subject at increased risk from participating in the study or otherwise prevent a patient"s participation in the study
Intervention: Tezacaftor
Trial phase: Phase 2
ATC code: R07AX31 | R07AX32
SMILES: CC(C)(CO)c1cc2cc(NC(=O)C3(c4ccc5c(c4)OC(F)(F)O5)CC3)c(F)cc2n1C[C@@H](O)CO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: All participants in group 5a who received VX-661 150 mg tablet orally qd for up to 28 days.
Eligibility criteria:
Inclusion Criteria:

Male or female with confirmed diagnosis of CF
Must have the F508del-CFTR gene mutation in both alleles (Groups 1, 2, 3, 4, 5, 6). Group 7 participants must have the F508del-CFTR mutation on 1 allele, and gating mutation G551D on the second allele and have been on their physician prescribed 150 mg KalydecoTM q12h (commercially available ivacaftor) for at least 28 days at the Screening Visit.
Forced expiratory volume in 1 second(FEV1) 40% to 90% (inclusive) of predicted normal for age, gender, and height (Knudson standards) at screening
Weight >40 kg and BMI >18.5
Participants of child-bearing potential and who are sexually active must meet the contraception requirements.

Exclusion Criteria:

History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant.
An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before Study Day 1.
History of solid organ or hematological transplantation
Participation in a clinical study involving administration of either an investigational or a marketed drug within 30 days or 5 terminal half-lives (whichever is longer) before screening
History of alcohol, medication, or illicit drug abuse within 1 year prior to screening
Pregnant, breast-feeding, or not willing to follow contraception requirements