anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Nepicastat
Trial phase: Phase 2
SMILES: NCc1c[nH]c(=S)n1[C@H]1CCc2c(F)cc(F)cc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 90
Group description: Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks

Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.
Eligibility criteria:
Inclusion Criteria:

Be at least 18 years of age
Is seeking treatment for cocaine dependence
Is able to understand and provide written informed consent
Has completed all psychological assessments and procedures required during the 7 - 14 day screening period
If female, agrees to use an acceptable method of birth control
Is, in the opinion of the Investigator, likely to complete the 11-week Treatment Phase of the study

Exclusion Criteria:

Please contact the study site for more information
Intervention: Timolol Maleate
Trial phase: Phase 2
SMILES: CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.O=C(O)C=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks.

Timolol maleate: Topical ophthalmic solution
Eligibility criteria:
Inclusion Criteria:

Subjects must have a diagnosis of OAG or OHT in 1 or both eyes.
Subjects who are treatment-naïve must meet the following IOP requirements at Visit 1 (Screening), and pretreated subjects must meet the following IOP requirements at Visit 2 (Washout): Intraocular pressure ≥ 22 mmHg in at least 1 eye and ≤ 36 mmHg in both eyes.

Exclusion Criteria:

Subjects who have been exposed to BOL-303259-X within 3 months prior to Visit 1 (Screening).
Subjects with a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the results of the study.
Subjects with an irregular daily sleep schedule.
Subjects who are unable to wear sleep monitoring device for 7 days prior to laboratory study.
Subjects with an anticipated need to initiate or modify medication (systemic or topical) that is known to affect IOP.
Subjects for whom concomitant use of medications may interact with the safety or efficacy of a nitric oxide.
Subjects with known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs.
Subjects who are expected to require treatment with ocular or systemic corticosteroids.
Subjects who are in need of any other topical or systemic treatment of OAG or OHT.
Subjects who are unable to discontinue contact lens use during and for 24 hours before the laboratory study.
Subjects with a central corneal thickness greater than 600 μm in either eye.
Subjects with any condition that prevents reliable applanationtonometry in either eye.
Subjects with advanced glaucoma and subjects with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.
Subjects with previous or active corneal disease.
Subjects with a history of severe dry eye.
Subjects with active optic disc hemorrhage.
Subjects with a history of central/branch retinal vein or artery occlusion.
Subjects with a history of macular edema.
Subjects with very narrow angles and subjects with angle closure, congenital, and secondary glaucoma, and subjects with history of angle closure in either eye.
Subjects with a diagnosis of a clinically significant or progressive retinal disease in either eye.
Subjects with any intraocular infection or inflammation within 3 months prior to Visit 1 (Screening).
Subjects with a history of ocular laser surgery within the 3 months prior to Visit 1 (Screening).
Subjects with a history of incisional ocular surgery or severe trauma within 3 months prior to Visit 1 (Screening).
Intervention: Quercetin
Trial phase: Phase 1
SMILES: O=c1c(O)c(-c2ccc(O)c(O)c2)oc2cc(O)cc(O)c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin
Eligibility criteria:
Inclusion Criteria:

Subjects diagnosed with mild to moderate COPD (GOLD stage I, II and III)-
10 pack-year smoking history or greater and ceased to smoke at least for 2 months prior to recruitment
Subjects taking H2 antagonists, Imodium or loratadine and willing to stop during the study period

Exclusion criteria:

COPD subjects with >80% or <35% predicted
Current smokers
Known allergy/sensitivity to quercetin
Subjects with primary diagnosis of asthma
Upper respiratory tract infection within two weeks of the screening visit
Acute bacterial infection requiring antibiotics within two weeks of screening
Emergency treatment or hospitalization within one month of screening
Pregnant or lactating mothers
Women who don't consent to take pregnancy test
Unwillingness to stop flavonoid supplementation
Dietary intake exceeding or averaging 150 mg quercetin daily as assessed by Bioflavonoid Food and Supplement Screener
Daily oral steroid treatment, warfarin, cyclosporine (neural, sandimmune), digoxin, fexofenadine, paclitaxel, diltiazem, saquinavir, selected chemotherapeutic agents (etoposide, vinblastine, vincristine, vindesine), antifungals (ketoconazole, itraconazole), protease inhibitors (amprenavir, indinavir, nelfinavir), verapamil, oral glucocorticoids, erythromycin, quinidine
Subjects taking H2 antagonists (cimetidine, ranitidine), loperamide (Imodium) or loratadine and not willing to stop during study period
Lung cancer history or undergoing chemo- or radiation therapy
Inflammatory bowel disease
Child bearing age, who are unwilling to use adequate contraception or abstain during the course of the study.
Intervention: Quercetin
Trial phase: Phase 1
SMILES: O=c1c(O)c(-c2ccc(O)c(O)c2)oc2cc(O)cc(O)c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin
Eligibility criteria:
Inclusion Criteria:

Subjects diagnosed with mild to moderate COPD (GOLD stage I, II and III)-
10 pack-year smoking history or greater and ceased to smoke at least for 2 months prior to recruitment
Subjects taking H2 antagonists, Imodium or loratadine and willing to stop during the study period

Exclusion criteria:

COPD subjects with >80% or <35% predicted
Current smokers
Known allergy/sensitivity to quercetin
Subjects with primary diagnosis of asthma
Upper respiratory tract infection within two weeks of the screening visit
Acute bacterial infection requiring antibiotics within two weeks of screening
Emergency treatment or hospitalization within one month of screening
Pregnant or lactating mothers
Women who don't consent to take pregnancy test
Unwillingness to stop flavonoid supplementation
Dietary intake exceeding or averaging 150 mg quercetin daily as assessed by Bioflavonoid Food and Supplement Screener
Daily oral steroid treatment, warfarin, cyclosporine (neural, sandimmune), digoxin, fexofenadine, paclitaxel, diltiazem, saquinavir, selected chemotherapeutic agents (etoposide, vinblastine, vincristine, vindesine), antifungals (ketoconazole, itraconazole), protease inhibitors (amprenavir, indinavir, nelfinavir), verapamil, oral glucocorticoids, erythromycin, quinidine
Subjects taking H2 antagonists (cimetidine, ranitidine), loperamide (Imodium) or loratadine and not willing to stop during study period
Lung cancer history or undergoing chemo- or radiation therapy
Inflammatory bowel disease
Child bearing age, who are unwilling to use adequate contraception or abstain during the course of the study.
Intervention: Quercetin
Trial phase: Phase 1
SMILES: O=c1c(O)c(-c2ccc(O)c(O)c2)oc2cc(O)cc(O)c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin
Eligibility criteria:
Inclusion Criteria:

Subjects diagnosed with mild to moderate COPD (GOLD stage I, II and III)-
10 pack-year smoking history or greater and ceased to smoke at least for 2 months prior to recruitment
Subjects taking H2 antagonists, Imodium or loratadine and willing to stop during the study period

Exclusion criteria:

COPD subjects with >80% or <35% predicted
Current smokers
Known allergy/sensitivity to quercetin
Subjects with primary diagnosis of asthma
Upper respiratory tract infection within two weeks of the screening visit
Acute bacterial infection requiring antibiotics within two weeks of screening
Emergency treatment or hospitalization within one month of screening
Pregnant or lactating mothers
Women who don't consent to take pregnancy test
Unwillingness to stop flavonoid supplementation
Dietary intake exceeding or averaging 150 mg quercetin daily as assessed by Bioflavonoid Food and Supplement Screener
Daily oral steroid treatment, warfarin, cyclosporine (neural, sandimmune), digoxin, fexofenadine, paclitaxel, diltiazem, saquinavir, selected chemotherapeutic agents (etoposide, vinblastine, vincristine, vindesine), antifungals (ketoconazole, itraconazole), protease inhibitors (amprenavir, indinavir, nelfinavir), verapamil, oral glucocorticoids, erythromycin, quinidine
Subjects taking H2 antagonists (cimetidine, ranitidine), loperamide (Imodium) or loratadine and not willing to stop during study period
Lung cancer history or undergoing chemo- or radiation therapy
Inflammatory bowel disease
Child bearing age, who are unwilling to use adequate contraception or abstain during the course of the study.
Intervention: Perflutren
Trial phase: Phase 4
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent

Optison echocardiography contrast agent: Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus.
Eligibility criteria:
Inclusion Criteria:

> 18 years old
Cognitively sound and able to provide informed consent
Indicated for TEE as a standard clinical procedure for evaluation of cardiac health status.

Exclusion Criteria:

Contraindicated for Optison administration
Known right-to-left or bi-directional cardiac shunts
Hypersensitivity to perflutren, blood, blood products or albumen
Women who are pregnant
Removal of Left Atrial Appendage
Not able to provide informed consent
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 20
Group description: IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.

IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only.
Eligibility criteria:
Inclusion Criteria:

Children 5-13 years of age
Surgical procedure: tonsillectomy with or without adenoidectomy
American Society of Anesthesiologists physical status classification 1 and 2 (patients that have either no systemic illness or mild systemic disease that is well-controlled, e.g. mild asthma)

Exclusion Criteria:

Known allergy to study medication(s)
Known genetic abnormality
Known hepatitis
Children with other physical, mental or medical conditions which, in the opinion of the PI, make study participation inadvisable or impairs pain assessment
Children who have taken any analgesic within 24 hours prior to surgery
Enrollment in concurrent research study
Pregnant patients*
Students/trainees/staff*
Mentally disabled/cognitively impaired*
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 19
Group description: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.

PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.
Eligibility criteria:
Inclusion Criteria:

Children 5-13 years of age
Surgical procedure: tonsillectomy with or without adenoidectomy
American Society of Anesthesiologists physical status classification 1 and 2 (patients that have either no systemic illness or mild systemic disease that is well-controlled, e.g. mild asthma)

Exclusion Criteria:

Known allergy to study medication(s)
Known genetic abnormality
Known hepatitis
Children with other physical, mental or medical conditions which, in the opinion of the PI, make study participation inadvisable or impairs pain assessment
Children who have taken any analgesic within 24 hours prior to surgery
Enrollment in concurrent research study
Pregnant patients*
Students/trainees/staff*
Mentally disabled/cognitively impaired*
Intervention: Rocuronium
Trial phase: Phase 4
ATC code: M03AC09
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron

Rocuronium
Eligibility criteria:
Inclusion Criteria:

Elective laparoscopic hysterectomy (total/subtotal)
Can read and understand Danish
Informed consent

Exclusion Criteria:

BMI > 30 kg/cm2
Known allergy to medications that are included in the project
Severe renal disease, defined by S-creatinine > 0,200 mmol/L, GFR < 30ml/min or hemodialysis)
Neuromuscular disease that may interfere with neuromuscular data
Lactating
Impaired liver function
Indication for rapid sequence induction (esophageal reflux/ hiatus hernia/other cause)
Intervention: Ganaxolone
Trial phase: Phase 2
ATC code: N03AX27
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](C(C)=O)CC[C@@]34[H])[C@@]1(C)CC[C@@](C)(O)C2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 59
Group description: Participants who received Ganaxolone up to 12 mg/kg tid in the first 6 weeks or last 6 weeks of the study.
Eligibility criteria:
Inclusion Criteria:

molecular documentation of FMR1 full mutation
ages 6-17 yrs, inclusive
sexually active subjects are required to use a medically acceptable form of birth control

Exclusion Criteria:

non-English or Spanish speaking subjects
concomitant systemic steroid, vigabatrin, felbamate and ketoconazole
changes in medications within last 2 months
clinically unstable medical disease, progressive CNS disease/disorder
history of recurrent status epilepticus
unwilling to withhold grapefruit or grapefruit juice for the duration of the study
actively suicidal
Intervention: Metformin
Trial phase: Phase 4
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Healthy controls receiving 1000 mg metformin twice daily for 3 months

Metformin: 1000 mg metformin twice daily in 3 months
Eligibility criteria:
Inclusion Criteria:

Recently diagnosed type 2 diabetes
Age 50-70 years
BMI<40

Exclusion Criteria:

Insulin treatment
NASH (non alcoholic steatohepatitis)
Cancer
Anemia
HbA1C>8.5 %
Chronic or acute pancreatitis
Alcohol or medicine abuse
Allergy towards metformin
Claustrophobia
Severe obesity (weight >130 kilogram)
Intervention: Metformin
Trial phase: Phase 4
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Metformin "Teva", 1000 mg twice daily for 3 months

Metformin: 1000 mg metformin twice daily in 3 months
Eligibility criteria:
Inclusion Criteria:

Recently diagnosed type 2 diabetes
Age 50-70 years
BMI<40

Exclusion Criteria:

Insulin treatment
NASH (non alcoholic steatohepatitis)
Cancer
Anemia
HbA1C>8.5 %
Chronic or acute pancreatitis
Alcohol or medicine abuse
Allergy towards metformin
Claustrophobia
Severe obesity (weight >130 kilogram)
Intervention: Hydrocortisone
Trial phase: Phase 2
ATC code: A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response

Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment
Eligibility criteria:
Inclusion Criteria:

Known CAH due to 21-hydroxylase deficiency (classic CAH) based on hormonal and genetic testing currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone on a stable dosage for a minimum of 3 months.
Male or female patients aged 18 and above.
Provision of signed written informed consent.
Good general health.
Females of childbearing potential must have a negative pregnancy test initially and at all visits. Females who are engaging in sexual intercourse must be using a medically acceptable method of contraception (as defined in the protocol, section 10.5).
Plasma renin activity must be within the clinically acceptable range at screening (less than 1.5 times upper normal range).

Exclusion Criteria:

Co-morbid condition requiring daily administration of a medication that induces hepatic enzymes or interferes with the metabolism of glucocorticoids.
Clinical or biochemical evidence of hepatic or renal disease. Creatinine above the normal range or elevated liver function tests (ALT or AST) > 2 times the upper limits of normal.
Females who are pregnant or lactating.
Women taking an estrogen-containing oral contraceptive pill and who have taken it within 6 weeks of recruitment.
Patients taking spironolactone.
Patients on inhaled or oral steroids apart from treatment for CAH.
Patients with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the trial.
Participation in another clinical trial of an investigational or licensed drug or device within the 3 months prior to inclusion in this study.
Patients with history of bilateral adrenalectomy.
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 108
Group description: Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)

Acetaminophen
Eligibility criteria:
Inclusion Criteria:

Patients' ≥ 6 months - 6 years
Patients must meet criteria for American Society of Anesthesiologists (ASA) physical status I, II.
Patients must not be pre-medicated.
Parents must give written consent on the surgery day and be able to sign informed consent form on the surgery day.
Undergoing BMT surgery only.

Exclusion Criteria:

Patients' <6 months and >6 years.
Patients with known allergies to any of the medications used in this study.
Patients with ASA status III & IV.
Patients taking prescription pain medications prior to surgery.
Patients taking medication that can cause drowsiness or alter mental status (eg. benzodiazepines, cough suppressants, diphenhydramine)
Patients with significant history of psychiatric illness, neurologic disease (seizure disorder requiring medication therapy), and developmental delay.
Patients have been pre-medicated.
Patients undergoing other procedures that would prolong anesthetic exposure or confound post-operative pain.
Intra-op complication that would require prolonged anesthetic exposure.
If patient took acetaminophen prior to surgery and was not supposed to do so
Patients that received ketorolac or additional analgesia during surgery.
Patients that have liver disease.
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 108
Group description: Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)

Acetaminophen
Eligibility criteria:
Inclusion Criteria:

Patients' ≥ 6 months - 6 years
Patients must meet criteria for American Society of Anesthesiologists (ASA) physical status I, II.
Patients must not be pre-medicated.
Parents must give written consent on the surgery day and be able to sign informed consent form on the surgery day.
Undergoing BMT surgery only.

Exclusion Criteria:

Patients' <6 months and >6 years.
Patients with known allergies to any of the medications used in this study.
Patients with ASA status III & IV.
Patients taking prescription pain medications prior to surgery.
Patients taking medication that can cause drowsiness or alter mental status (eg. benzodiazepines, cough suppressants, diphenhydramine)
Patients with significant history of psychiatric illness, neurologic disease (seizure disorder requiring medication therapy), and developmental delay.
Patients have been pre-medicated.
Patients undergoing other procedures that would prolong anesthetic exposure or confound post-operative pain.
Intra-op complication that would require prolonged anesthetic exposure.
If patient took acetaminophen prior to surgery and was not supposed to do so
Patients that received ketorolac or additional analgesia during surgery.
Patients that have liver disease.