anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Fulvestrant
Trial phase: Phase 1 | Phase 2
ATC code: L02BA03
SMILES: [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])c3ccc(O)cc3C[C@@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).

Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily.
Eligibility criteria:
Inclusion Criteria:

Roux-en-Y gastric bypass hyperoxaluric Calcium oxalate (CaOx) stone subjects or Idiopathic hyperoxaluric CaOx stone subjects
Patients must have or had radio-opaque stones present on x-ray, or a history consistent with the passage of a stone or stone surgery or Extracorporeal Shock Wave Lithotripsy (ESWL) in the last 5 years.
Hyperoxaluria Ox/Cr ratio ≥36 mg/g
The patient must be able to provide written informed consent
Patients must be able to urinate reliably into a collection vessel to measure urine volume.
Patients may be taking drugs for the prevention of stone disease, including pyridoxine, thiazides, citrate supplements and allopurinol, as long as there have been no changes in these medications for at least 3 months

Exclusion Criteria:

Primary hyperoxaluria patients
Use of Oxadrop, Oxabsorb, or other therapies affecting oxalate absorption from the gut, other than stable doses of calcium.
Subjects who are pregnant. Women of childbearing potential must have a negative pregnancy test prior to enrollment and must practice some form of birth control during the trial.
Patients on an unstable dose of any other drugs for the prevention of stone disease (i.e., pyridoxine, citrate supplements. etc.). Patients should have been on a stable dose for at least 3 months prior to randomization.
Intervention: Fulvestrant
Trial phase: Phase 1 | Phase 2
ATC code: L02BA03
SMILES: [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])c3ccc(O)cc3C[C@@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Subjects with idiopathic hyperoxaluria.

Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily.
Eligibility criteria:
Inclusion Criteria:

Roux-en-Y gastric bypass hyperoxaluric Calcium oxalate (CaOx) stone subjects or Idiopathic hyperoxaluric CaOx stone subjects
Patients must have or had radio-opaque stones present on x-ray, or a history consistent with the passage of a stone or stone surgery or Extracorporeal Shock Wave Lithotripsy (ESWL) in the last 5 years.
Hyperoxaluria Ox/Cr ratio ≥36 mg/g
The patient must be able to provide written informed consent
Patients must be able to urinate reliably into a collection vessel to measure urine volume.
Patients may be taking drugs for the prevention of stone disease, including pyridoxine, thiazides, citrate supplements and allopurinol, as long as there have been no changes in these medications for at least 3 months

Exclusion Criteria:

Primary hyperoxaluria patients
Use of Oxadrop, Oxabsorb, or other therapies affecting oxalate absorption from the gut, other than stable doses of calcium.
Subjects who are pregnant. Women of childbearing potential must have a negative pregnancy test prior to enrollment and must practice some form of birth control during the trial.
Patients on an unstable dose of any other drugs for the prevention of stone disease (i.e., pyridoxine, citrate supplements. etc.). Patients should have been on a stable dose for at least 3 months prior to randomization.
Intervention: Dinoprostone
Trial phase: Phase 3
ATC code: G02AD02
SMILES: CCCCC[C@H](O)/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1C/C=C\CCCC(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 680
Group description: 10 mg Dinoprostone vaginal insert

Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
Eligibility criteria:
Inclusion Criteria:

Provide written informed consent;
Pregnant women at ≥ 36 weeks 0 days inclusive gestation;
Women aged 18 years or older;
Candidate for pharmacological induction of labor;
Single, live vertex fetus;
Baseline modified Bishop score ≤ 4;
Parity ≤ 3 (parity is defined as one or more births live or dead after 24 weeks gestation);
Body Mass Index (BMI) ≤ 50 at the time of entry to the study.

Exclusion Criteria:

Women in active labor;
Presence of uterine or cervical scar or uterine abnormality e.g., bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or gestational hypertension;
Severe pre-eclampsia marked by Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP) syndrome, other end-organ affliction or Central Nervous System (CNS) findings other than mild headache;
Fetal malpresentation;
Diagnosed congenital anomalies, not including polydactyly;
Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
Amnioinfusion or other treatment of non-reassuring fetal status at any time prior to the induction attempt;
Ruptured membranes ≥ 48 hours prior to the start of treatment;
Suspected chorioamnionitis;
Fever (oral or aural temperature > 37.5°C);
Any condition in which vaginal delivery is contraindicated e.g., placenta previa or any unexplained genital bleeding at any time after 24 weeks during this pregnancy;
Known or suspected allergy to misoprostol, dinoprostone, other prostaglandins or any of the excipients;
Any condition urgently requiring delivery;
Unable to comply with the protocol.
Intervention: Saxagliptin
Trial phase: Phase 3
ATC code: A10BD10 | A10BD21 | A10BD25 | A10BH03
SMILES: N#CC1CC2CC2N1C(=O)C(N)C12CC3CC(CC(O)(C3)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 129
Group description: Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
Eligibility criteria:
Inclusion Criteria:

Written Informed Consent
Males or females with type 2 diabetes with inadequate glycaemic control (HbA1c > or = 7% and < or = 10%) despite being on combination of metformin and sulfonylurea for at least 8 weeks prior to Visit 1
BMI < or = 40 kg/m2

Exclusion Criteria:

Symptoms of poorly controlled diabetes including but not limited to marked polyuria and marked polydipsia with > 10% weight loss in 3 months prior to entry, or other signs and symptoms
History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
Current or prior use within 3 months of Visit 1 of insulin, DDP4 inhibitor, GLP-1 analogues, and/or other oral anti-diabetic agents (other than metformin or sulfonylurea)
Treatment with CYP3A4 inducers and/or potent CYP3A4/5 inhibitor
Estimated CrCl < 60 ml/min at Visit 2
CHF (NYHA class III or IV) and/or LVEF <40%
Active liver disease and/or significant abnormal liver function defined as AST and/or ALT > 3 x ULN and/or bilirubin > 2.0 mg/dL at Visit 2.
Creatine kinase > or = 10 x ULN at Visit 2
Intervention: Lanthanum Carbonate
Trial phase: Phase 2
ATC code: V03AE03
SMILES: O=C([O-])[O-].O=C([O-])[O-].O=C([O-])[O-].[La+3].[La+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: 1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Subjects meeting all of the criteria listed below may be included in the study:

≥18 years old.
Male, or non-pregnant, non-lactating females who agree to comply with any applicable contraceptive requirements of the protocol.
Been in the care of a physician for CKD for >2 months, and are not expected to begin dialysis for at least 6 months.
Screening serum c-terminal FGF23 > 50.0RU/mL.
Screening estimated glomerular filtration rate (eGFR) of 30-59mL/min/1.73m2 using the MDRD formula.
Normal serum phosphate (0.808-1.55mmol/L).
Endogenous 25-hydroxy Vitamin D levels >20ng/mL.
Adequate protein diet (includes 2-3 portions of protein-rich food per day).
An understanding, ability, and willingness to fully comply with study procedures and restrictions.
Ability to provide written, signed, and dated (personally) informed consent to participate in the study.

Exclusion Criteria

Vitamin D supplementation required.
Compounds containing calcium, phosphate, aluminium or magnesium required.
Acute renal failure.
Rapidly progressing glomerulonephritis.
Vegetarian diet.
Known allergy to iodine.
Clinically significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair subjects' ability to give informed consent or take part in or complete this clinical study.
Cirrhosis or other clinically significant liver disease (aspartate transaminase (AST) or alanine transaminase (ALT) >3 times the upper limit of normal or bilirubin >2 times the upper limit of normal).
Past (treated within the last 5 years) or present GI disorders including uncontrolled peptic ulcer, Crohn's disease (or other conditions where the integrity of the GI tract may be compromised), malignancy, or GI bleed within the last 6 months.
Life-threatening malignancy or current multiple myeloma.
Known to be Human Immunodeficiency Virus (HIV) positive.
History of poor compliance with diet or medication that in the Investigator's opinion may interfere with adherence to the protocol.
History of alcohol or other substance abuse within 6 months prior to screening.
Subjects must not have used another investigational medicinal product or taken part in a clinical trial within the last 30 days prior to enrolment.
Subjects who have previously been enrolled into this study and subsequently withdrawn.
Intervention: Aminolevulinic Acid
Trial phase: Phase 1 | Phase 2
ATC code: L01XD04
SMILES: NCC(=O)CCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Phase 2 Dose (40mg/kg): Participants were given a one-time, single-dose administration of oral 40mg/kg Aminolevulinic Acid (5-ALA)
Eligibility criteria:
Inclusion Criteria:

Patients must have clinically documented primary brain tumor for which resection is clinically indicated.
Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of 5-ALA in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric phase 1 single-agent trials
ECOG (Eastern Cooperative Oncology Group) performance status <2 (Karnofsky >60%)

Normal organ and marrow function as defined below:

Leukocytes > 3,000/mcL (microliter)
Absolute neutrophil count > 1,500/mcL
Platelets > 100,000/mcL
Total bilirubin within normal institutional limits AST (aspartate aminotransferase) (SGOT)/ALT (alanine transaminase) (SGPT) < 2.5 X institutional upper limit of normal
Creatinine within normal institutional limits OR Creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Agreement by women of child-bearing potential and men to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Patients may not be receiving any other investigational agents at the time of entry into the study
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 5-ALA
Personal or family history of porphyrias
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study because 5-ALA is of unknown teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 5-ALA, breastfeeding should be discontinued if the mother is treated with 5-ALA
Intervention: SODIUM FLUORIDE
Trial phase: Phase 2
ATC code: A01AA01 | A01AA51 | A12CD01 | V09IX06
SMILES: [F-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
Eligibility criteria:
Inclusion Criteria:

An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch - subjects may have fixed bridges replacing missing teeth
No current active caries or periodontal disease that may compromise the study or the health of the subjects
A gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute and an unstimulated whole saliva flow rate greater than or equal to 0.2 mL/minute

Exclusion Criteria:

Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Intervention: Aliskiren
Trial phase: Phase 4
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
Eligibility criteria:
Inclusion Criteria:

Proteinuria > 300 mg/day
Normal to mildly reduced kidney function (eGFR > 45 ml/min/1.73m2)
Systolic blood pressure >130 mm Hg
Diastolic blood pressure >70 mm Hg
Diagnoses of diabetic nephropathy, hypertensive nephrosclerosis, IgA nephropathy, focal segmental glomerulosclerosis, membranoproliferative glomerulonephritis, membranous nephropathy, fibrillary glomerulonephritis, or obesity-associated glomerulopathy

Exclusion Criteria:

Concomitant use of cyclosporine (which can interact with aliskiren)
Inability to undergo 6 week washout period if already on RAAS-blocking drug(s) (includes renin inhibitor, ACE-inhibitor, ARB, and mineralocorticoid receptor blocker)
eGFR < 45 ml/min/1.73m2
Urine protein excretion < 300 mg/day
Serum K > 5.0 mEq/l
Systolic blood pressure > 170 mm Hg or < 130 mm Hg after washout period
Diastolic blood pressure > 110 mm Hg or < 70 mm Hg after washout period
Congestive heart failure NYHA class III and IV
History of any cardiovascular events (stroke, TIA, MI, unstable angina, CABG, PCI, CHF hospitalization) in 3 months prior to study visit 1
2nd or 3rd degree heart block without a pacemaker or other uncontrolled arrhythmia
Clinically significant valvular disease
Known renal artery stenosis
Any surgical or medical condition that might significantly alter the pharmacokinetics of the study drugs (n.b. bariatric surgery > 6 months prior to visit 1 is not an exclusion)
History or evidence of drug or alcohol abuse within the last 12 months
Any concurrent life threatening condition with a life expectancy less than 2 years
Pregnant or nursing (lactating) women
Women of child-bearing potential unless postmenopausal for at least 1 year, surgically sterile, or using effective methods of contraception as defined by local health authorities
Intervention: Valsartan
Trial phase: Phase 4
ATC code: C09CA03 | C09DA03 | C09DB01 | C09DB08 | C09DX01 | C09DX02 | C09DX04 | C09DX05 | C10BX10
SMILES: CCCCC(=O)N(Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1)[C@H](C(=O)O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
Eligibility criteria:
Inclusion Criteria:

Proteinuria > 300 mg/day
Normal to mildly reduced kidney function (eGFR > 45 ml/min/1.73m2)
Systolic blood pressure >130 mm Hg
Diastolic blood pressure >70 mm Hg
Diagnoses of diabetic nephropathy, hypertensive nephrosclerosis, IgA nephropathy, focal segmental glomerulosclerosis, membranoproliferative glomerulonephritis, membranous nephropathy, fibrillary glomerulonephritis, or obesity-associated glomerulopathy

Exclusion Criteria:

Concomitant use of cyclosporine (which can interact with aliskiren)
Inability to undergo 6 week washout period if already on RAAS-blocking drug(s) (includes renin inhibitor, ACE-inhibitor, ARB, and mineralocorticoid receptor blocker)
eGFR < 45 ml/min/1.73m2
Urine protein excretion < 300 mg/day
Serum K > 5.0 mEq/l
Systolic blood pressure > 170 mm Hg or < 130 mm Hg after washout period
Diastolic blood pressure > 110 mm Hg or < 70 mm Hg after washout period
Congestive heart failure NYHA class III and IV
History of any cardiovascular events (stroke, TIA, MI, unstable angina, CABG, PCI, CHF hospitalization) in 3 months prior to study visit 1
2nd or 3rd degree heart block without a pacemaker or other uncontrolled arrhythmia
Clinically significant valvular disease
Known renal artery stenosis
Any surgical or medical condition that might significantly alter the pharmacokinetics of the study drugs (n.b. bariatric surgery > 6 months prior to visit 1 is not an exclusion)
History or evidence of drug or alcohol abuse within the last 12 months
Any concurrent life threatening condition with a life expectancy less than 2 years
Pregnant or nursing (lactating) women
Women of child-bearing potential unless postmenopausal for at least 1 year, surgically sterile, or using effective methods of contraception as defined by local health authorities
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
Eligibility criteria:
Inclusion Criteria:

Capable of providing informed consent
18 years old and older
Elbow fractures that require operative intervention including:
Supracondylar distal humerus fractures
Intra-articular distal humerus fractures
Proximal ulna and radius fractures

Exclusion Criteria:

Patients less than 18 years old
Injuries that do not normally require surgical repair
Patients with underlying spasticity
Patients with burns about the elbow
Patients with extensive soft tissue injuries of the elbow
Patients with head or spinal cord injuries
Myasthenia gravis, Eaton-Lambert, amyotrophic lateral sclerosis or any other disease that interferes with neuromuscular function
Use of aminoglycoside antibiotics or other drug therapies that interfere with neuromuscular function
Intervention: Letrozole
Trial phase: Phase 2
ATC code: L02BG04
SMILES: N#Cc1ccc(C(c2ccc(C#N)cc2)n2cncn2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 14
Group description: Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
Eligibility criteria:
Inclusion Criteria:

Women are eligible to participate if they are 40 years or older and have been menopausal (had no menstrual bleeding during the past 12 months)

Exclusion Criteria:

History of bilateral mastectomy, osteoporosis or renal impairment.
Intervention: Aripiprazole
Trial phase: Phase 3
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 709
Group description: Monthly dose of 400 milligrams (mg) or 300 mg aripiprazole intramuscular (IM) depot to adult participants with schizophrenia who completed aripiprazole IM depot treatment in Study 31-08-248.
Eligibility criteria:
Inclusion Criteria:

Participants with a current diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria, who completed the open-label extension Study 248 (completed Study 248 study completion visit, Week 52).
Participants who, in the investigator's judgment, may benefit from continued participation in an aripiprazole IM Depot study.
The baseline visit for Study 270 (which is the Week 52 visit of Study 248) and the first injection for Study 270 must occur within 4 weeks (which was defined as 28 [-2/+10] days) of the last injection in Study 248.
Participants who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by an Independent Review Board/Independent Ethics Committee (IRB/IEC), prior to the initiation of any protocol-required procedures.
Participants able to understand the nature of the study and follow protocol requirements and who can read and understand the written word in order to complete patient-reported outcomes measures.
Outpatient status.

Exclusion Criteria:

Participants with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic, or other cognitive disorders.
Participants with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
Participants who currently meet DSM-IV-TR criteria for substance dependence, including alcohol and benzodiazepines, but excluding caffeine and nicotine.
Participants with a significant risk of violent behavior or a significant risk of committing suicide based on the investigator's judgment.
Participants who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
Participants with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.
Electroconvulsive therapy within 180 days prior to entry.
Any participant who requires or may need any other antipsychotic medications during the course of the study.
Aripiprazole IM Depot (including generic formulation) is commercially available in the participant's country.
Other protocol specific inclusion/exclusion criteria may apply.