anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Pasireotide
Trial phase: Phase 3
ATC code: H01CB05
SMILES: NCCCC[C@@H]1NC(=O)[C@@H](Cc2c[nH]c3ccccc23)NC(=O)[C@H](c2ccccc2)NC(=O)[C@@H]2C[C@@H](OC(=O)NCCN)CN2C(=O)[C@H](Cc2ccccc2)NC(=O)[C@H](Cc2ccc(OCc3ccccc3)cc2)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: Pasireotide LAR 60 mg
Eligibility criteria:
Inclusion Criteria:

Patients with written informed consent prior to any study related activity
Patients who had inadequately controlled acromegaly as defined by a mean GH concentration of a 5-point profile over a 2-hour period > 2.5 µg/L and sex- and age-adjusted IGF-1 > 1.3 x upper limit of normal (ULN)
Patients who had been treated with maximum indicated doses of octreotide LAR or lanreotide ATG for at least 6 months prior to visit 1 (screening). The maximum indicated dose for octreotide LAR was 30mg and for lanreotide ATG iwas120 mg
Patients who had a diagnosis of pituitary micro- or macro adenoma. Patients could have been previously submitted to surgery
Patients who completed the 24-week treatment period in core according to the requirements of the core study protocol or corresponding amendments could enter extension

Exclusion Criteria:

Patients who had received pasireotide (SOM 230) prior to enrolment
Concomitant treatment with Growth Hormone Receptor (GHR)-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to visit 1 (screening)(8 weeks wash out period). Such patients must have been treated with octreotide LAR 30 mg or lanreotide ATG 120 mg monotherapy continuously for a minimum of 6 months prior to starting combination therapy and they should have been inadequately controlled on monotherapy.
Patients who had compression of the optic chiasm causing acute clinically significant visual field defects
Patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression
Patients who had received pituitary irradiation within 10 years prior to visit 1 (screening).
Patients who had undergone major surgery/surgical therapy for any cause within 4 weeks prior to visit 1 (screening).
Patients who were hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy
Intervention: Insulin
Trial phase: Phase 4
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(N)=O)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 56
Group description: Patients will receive IV insulin to maintain target glucose levels of 80-110 mg/dl
Eligibility criteria:
Inclusion Criteria:

non-traumatic SAH, ICH, or TBI
Glasgow Coma Scale between 6 and 14
admitted to an ICU of University of Louisville Hospital

Exclusion Criteria:

Patients <18 and >80 years
GCS Motor score <4 or an overall GCS score of 15
diabetic patients who suffer from dialysis-dependent diabetic nephropathy
patients with multiple injuries
patients who would have been classified as ASA 3 status prior to their acute neurological event
Intervention: Iopamidol
Trial phase: Phase 4
ATC code: V08AB04
SMILES: C[C@H](O)C(=O)Nc1c(I)c(C(=O)NC(CO)CO)c(I)c(C(=O)NC(CO)CO)c1I
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Non ionic contrast media comparator : one time administration for PCI
Eligibility criteria:
Inclusion Criteria:

Provides written Informed Consent and is willing to comply with protocol requirements;
Is at least 18 years of age;
Is scheduled to undergo a percutaneous coronary intervention and/or diagnostic coronary angiography.
Has documented estimated glomerular filtration rate [eGFR] ≥60 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior to enrollment.

Exclusion Criteria:

Is a pregnant or lactating female.
Has a history of severe congestive heart failure
Has a history of hyperthyroidism
Has a history of hypersensitivity to iodinated contrast agents
Has unstable renal function
Intervention: Iopamidol
Trial phase: Phase 4
ATC code: V08AB04
SMILES: C[C@H](O)C(=O)Nc1c(I)c(C(=O)NC(CO)CO)c(I)c(C(=O)NC(CO)CO)c1I
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Non ionic contrast media comparator : One time administration for PCI
Eligibility criteria:
Inclusion Criteria:

Provides written Informed Consent and is willing to comply with protocol requirements;
Is at least 18 years of age;
Is scheduled to undergo a percutaneous coronary intervention and/or diagnostic coronary angiography.
Has documented estimated glomerular filtration rate [eGFR] ≥60 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior to enrollment.

Exclusion Criteria:

Is a pregnant or lactating female.
Has a history of severe congestive heart failure
Has a history of hyperthyroidism
Has a history of hypersensitivity to iodinated contrast agents
Has unstable renal function
Intervention: Rifaximin
Trial phase: Not Applicable
ATC code: A07AA11 | D06AX11
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Antibiotic: Rifaximin 400mg orally three times a day for 10 days total
Eligibility criteria:
Inclusion Criteria:

Adult patients age 18 or older
Biopsy proven celiac disease
Persistent symptoms of diarrhea, gas, bloating and/or cramping despite a gluten free diet for at least 1 month
Women that are not pregnant or lactating can be included. All women must have a documented negative pregnancy test at the initiation of the study. Women who become pregnant during the study will be asked to discontinue the study drug and will be followed up until the outcome of pregnancy is known. Women of child bearing potential must be practicing an effective method of birth control (eg: prescription oral contraceptive, contraceptive injections, intra-uterine device (IUD), double barrier method, contraceptive patch, male sterilization) before entry and throughout the treatment period.

Exclusion Criteria:

antibiotic use for any indication within preceding one month
use of bismuth compounds within preceding month
concomitant use of pancreatic supplements
concomitant use of antispasmodics
concomitant use of immunomodulators such as corticosteroids, budesonide, alkylating agents and antimetabolites.
concomitant use of probiotics
concomitant use of prokinetic agents
concomitant use of 5-hydroxytryptamine receptor (5HT3) antagonists,5-hydroxytryptamine receptor (5HT4) antagonists.
concomitant use of antimotility agents (e.g loperamide)
concomitant use of antidiarrheal agents
diagnosed microscopic colitis or inflammatory bowel disease
other causes of malabsorption: pancreatic insufficiency, giardiasis and enteropathy associated with T cell lymphoma.
other diseases: renal or hepatic insufficiency.

pregnant patients and lactating females. In addition women of child bearing age will be excluded if they are not using one of the methods of contraception like oral contraceptives,intrauterine device.

and double barrier methods.

patients with tuberculosis or a positive purified protein derivative (PPD) test and infection with other mycobacterial diseases.
allergy and/or potential emergence of drug resistance to rifampicin and rifamycin compounds.
Intervention: Trexima
Trial phase: Phase 4
SMILES: CNS(=O)(=O)Cc1ccc2[nH]cc(CCN(C)C)c2c1.COc1ccc2cc(C(C)C(=O)[O-])ccc2c1.O=C(O)CCC(=O)O.[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 36
Group description: sumatriptan/naproxen sodium: One tablet of sumatriptan 85 mg and naproxen sodium 500 mg will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
Eligibility criteria:
Inclusion Criteria:

Age greater than 18 years of age, migraine

Exclusion Criteria:

Pregnant or breast-feeding women, presence of cardiovascular or cerebrovascular disorders as well as any known inflammatory, infectious, metabolic, thyroid, renal, cardiovascular or gastrointestinal diseases
Intervention: Omeprazole
Trial phase: Phase 2
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 83
Group description: esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
Eligibility criteria:
Inclusion Criteria:

We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months.

Exclusion Criteria:

1.serious disease 2.refuse informed consent
Intervention: Naproxen
Trial phase: Phase 2
ATC code: G02CC02 | M01AE02 | M01AE52 | M01AE56 | M02AA12
SMILES: COc1ccc2cc([C@H](C)C(=O)O)ccc2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 39
Group description: Naproxen: Oral administration
Eligibility criteria:
Inclusion Criteria (Selected)

Male and female healthy adult subjects

Exclusion Criteria (Selected)

Subject has protocol specified significant medical history.
Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study.
Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.
Intervention: OXYTOCIN
Trial phase: Not Applicable
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.
Eligibility criteria:
Inclusion Criteria:

Participant or surrogate is capable of giving informed consent
Anticipated number - 50 patients with 25 in each study arm Female with singleton gestation, live intrauterine pregnancy
Participant is undergoing an indicated induction of labor
Participant is found to have cervical Bishop score ≤5 on initial cervical exam
Participant has no medical or obstetrical contraindications to induction of labor

Exclusion Criteria:

Participant has ≥2 painful contractions in 10 min in 2 subsequent 10 min periods
Manufacturer's contraindications to misoprostol or oxytocin
Intervention: Clonidine
Trial phase: Phase 4
ATC code: C02AC01 | C02LC01 | C02LC51 | N02CX02 | S01EA04
SMILES: Clc1cccc(Cl)c1NC1=NCCN1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours

Clonidine: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours
Eligibility criteria:
Inclusion Criteria:

Ventilated male or female trauma patient 18 years of age or older admitted to the ICU >24 hours
Patient must meet minimal medical criteria for potential extubation (meet criteria for being placed on spontaneous breathing trials per established MUMC SBT protocol)
Patients must exhibit delirium as assessed by the CAM-ICU assessment tool
Patient must be declared stable from a neurologic, respiratory and cardiovascular standpoint to receive clonidine by the attending MD
Consent must be obtained prior to any study procedures

Exclusion Criteria:

Patient < 18 years old
Bradycardia (HR < 60)
Presence of active pacemaker
Hypotensive (<90/60)or active treatment of hypotension with vasoactive medications
Patient actively being treated with Clonidine or dexmedetomidine
Presence of allergy to Clonidine
Pregnancy
Intervention: MK-0873
Trial phase: Phase 1
SMILES: O=C(NC1CC1)c1cn(-c2cccc(C#Cc3ccc[n+]([O-])c3)c2)c2ncccc2c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
Eligibility criteria:
Inclusion Criteria:

Part I, II and III:

Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control;
In good general health;
Nonsmoker;

Part III only:

Has diagnosis of plaque-type psoriasis, and has lesions covering at least 3% of total body surface area;

Exclusion Criteria:

Part I, II and III:

Has a history of stroke, chronic seizures or major neurological disease;
Has a history of cancer;
Is a nursing mother;

Part III only:

Has nonplaque forms of psoriasis;
Has current drug-induced psoriasis;
Has received phototherapy, systemic medications/treatments, or used topical medication that could affect psoriasis;
Has used any systemic immunosuppressants or biologics within the past 4 weeks.
Intervention: MK-0873
Trial phase: Phase 1
SMILES: O=C(NC1CC1)c1cn(-c2cccc(C#Cc3ccc[n+]([O-])c3)c2)c2ncccc2c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
Eligibility criteria:
Inclusion Criteria:

Part I, II and III:

Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control;
In good general health;
Nonsmoker;

Part III only:

Has diagnosis of plaque-type psoriasis, and has lesions covering at least 3% of total body surface area;

Exclusion Criteria:

Part I, II and III:

Has a history of stroke, chronic seizures or major neurological disease;
Has a history of cancer;
Is a nursing mother;

Part III only:

Has nonplaque forms of psoriasis;
Has current drug-induced psoriasis;
Has received phototherapy, systemic medications/treatments, or used topical medication that could affect psoriasis;
Has used any systemic immunosuppressants or biologics within the past 4 weeks.
Intervention: MK-0873
Trial phase: Phase 1
SMILES: O=C(NC1CC1)c1cn(-c2cccc(C#Cc3ccc[n+]([O-])c3)c2)c2ncccc2c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
Eligibility criteria:
Inclusion Criteria:

Part I, II and III:

Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control;
In good general health;
Nonsmoker;

Part III only:

Has diagnosis of plaque-type psoriasis, and has lesions covering at least 3% of total body surface area;

Exclusion Criteria:

Part I, II and III:

Has a history of stroke, chronic seizures or major neurological disease;
Has a history of cancer;
Is a nursing mother;

Part III only:

Has nonplaque forms of psoriasis;
Has current drug-induced psoriasis;
Has received phototherapy, systemic medications/treatments, or used topical medication that could affect psoriasis;
Has used any systemic immunosuppressants or biologics within the past 4 weeks.
Intervention: Senna
Trial phase: Phase 4
ATC code: A06AB06 | A06AB56
SMILES: O=C(O)c1cc(O)c2c(c1)C(C1c3cc(C(=O)O)cc(O)c3C(=O)c3c(OC4OC(CO)C(O)C(O)C4O)cccc31)c1cccc(OC3OC(CO)C(O)C(O)C3O)c1C2=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Miralax colonoscopy preparation

polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.

Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days.
Eligibility criteria:
Inclusion Criteria:

Subjects age 6-21 yrs for senna, PEG-P groups
Subjects age 13-21 yrs for NaP group
First time colonoscopy
Patient weight <70 kg for PEG-P group (to not exceed 51 grams/dose)

Exclusion Criteria:

Chronic renal, liver, or heart failure
Chronic constipation
Patients on the GI inpatient or consult service.
Subjects taking senna or PEG on a regular basis for laxative reasons.
Pregnant or lactating females
Intervention: Senna
Trial phase: Phase 4
ATC code: A06AB06 | A06AB56
SMILES: O=C(O)c1cc(O)c2c(c1)C(C1c3cc(C(=O)O)cc(O)c3C(=O)c3c(OC4OC(CO)C(O)C(O)C4O)cccc31)c1cccc(OC3OC(CO)C(O)C(O)C3O)c1C2=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 33
Group description: Senna colonoscopy preparation

polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.

Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days.
Eligibility criteria:
Inclusion Criteria:

Subjects age 6-21 yrs for senna, PEG-P groups
Subjects age 13-21 yrs for NaP group
First time colonoscopy
Patient weight <70 kg for PEG-P group (to not exceed 51 grams/dose)

Exclusion Criteria:

Chronic renal, liver, or heart failure
Chronic constipation
Patients on the GI inpatient or consult service.
Subjects taking senna or PEG on a regular basis for laxative reasons.
Pregnant or lactating females
Intervention: Ataluren
Trial phase: Phase 3
ATC code: M09AX03
SMILES: O=C(O)c1cccc(-c2noc(-c3ccccc3F)n2)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 95
Group description: Participants who received double-blind ataluren during Study 009 continued to receive open-label ataluren taken 3 times per day (TID): 10 milligram (mg)/kilogram (kg) of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total dose 40 mg/kg/day), for up to 96 weeks. Participants were followed for 4 weeks after treatment.
Eligibility criteria:
Inclusion Criteria:

Completion of blinded study drug treatment in the previous Phase 3 study (PTC124-GD-009-CF).
Ability to provide written informed consent (parental/guardian consent if applicable)/assent (if <18 years of age).
In participants who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during ataluren administration and the 4-week follow up period.
Willingness and ability to comply with scheduled visits, drug administration plan, study procedures, laboratory tests, and study restrictions.

Exclusion Criteria:

Known hypersensitivity to any of the ingredients or excipients of the study drug (list provided at study sites).
Current pregnancy or lactating, or pregnancy or lactating during the previous Phase 3 study.
Ongoing participation in any other therapeutic clinical trial.
Prior or ongoing medical condition (for example, concomitant illness, psychiatric condition, behavioral disorder, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the Investigator's opinion, could adversely affect the safety of the participant, makes it unlikely that the course of treatment or follow up would be completed, or could impair the assessment of study results.
Intervention: Ataluren
Trial phase: Phase 3
ATC code: M09AX03
SMILES: O=C(O)c1cccc(-c2noc(-c3ccccc3F)n2)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 96
Group description: Participants who received double-blind placebo during Study 009 received open-label ataluren TID: 10 mg/kg of body weight with breakfast, 10 mg/kg with lunch, and 20 mg/kg with dinner (total dose 40 mg/kg/day), for up to 96 weeks. Participants were followed for 4 weeks after treatment.
Eligibility criteria:
Inclusion Criteria:

Completion of blinded study drug treatment in the previous Phase 3 study (PTC124-GD-009-CF).
Ability to provide written informed consent (parental/guardian consent if applicable)/assent (if <18 years of age).
In participants who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during ataluren administration and the 4-week follow up period.
Willingness and ability to comply with scheduled visits, drug administration plan, study procedures, laboratory tests, and study restrictions.

Exclusion Criteria:

Known hypersensitivity to any of the ingredients or excipients of the study drug (list provided at study sites).
Current pregnancy or lactating, or pregnancy or lactating during the previous Phase 3 study.
Ongoing participation in any other therapeutic clinical trial.
Prior or ongoing medical condition (for example, concomitant illness, psychiatric condition, behavioral disorder, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the Investigator's opinion, could adversely affect the safety of the participant, makes it unlikely that the course of treatment or follow up would be completed, or could impair the assessment of study results.