anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Asimadoline
Trial phase: Phase 2
SMILES: CN(C(=O)C(c1ccccc1)c1ccccc1)[C@H](CN1CC[C@H](O)C1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Asimadoline 1.0 mg b.i.d.
Eligibility criteria:
Inclusion Criteria:

Males and females aged 18-80
Must be scheduled to undergo a laparoscopic/hand-assisted laparoscopic segmental colectomy
Must sign an ICF
Females of childbearing potential must have a negative pregnancy test at screening

Exclusion Criteria:

Subjects with evidence of a biochemical or structural abnormality of the GI tract or other co-morbid illness that may impact the ability to interpret the safety and efficacy data
Pregnant or breastfeeding females
Use of investigational drugs in previous 30 days
Refusal to discontinue prohibited concomitant medications
Chronic use of prescription narcotics over the previous 6 months
Intervention: Asimadoline
Trial phase: Phase 2
SMILES: CN(C(=O)C(c1ccccc1)c1ccccc1)[C@H](CN1CC[C@H](O)C1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Asimadoline 3.0 mg b.i.d.
Eligibility criteria:
Inclusion Criteria:

Males and females aged 18-80
Must be scheduled to undergo a laparoscopic/hand-assisted laparoscopic segmental colectomy
Must sign an ICF
Females of childbearing potential must have a negative pregnancy test at screening

Exclusion Criteria:

Subjects with evidence of a biochemical or structural abnormality of the GI tract or other co-morbid illness that may impact the ability to interpret the safety and efficacy data
Pregnant or breastfeeding females
Use of investigational drugs in previous 30 days
Refusal to discontinue prohibited concomitant medications
Chronic use of prescription narcotics over the previous 6 months
Intervention: Duloxetine
Trial phase: Phase 4
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
Eligibility criteria:
Inclusion Criteria:

Subject is male or female between the ages of 18 and 65, inclusive
Subject has an IHS diagnosis of migraine with or without aura for at least one-year prior to screening
Subject has experienced between 4 and 10 migraine headaches per month (inclusive) over the past six months, with at least 24 hours separating attacks
Subject has less than 15 total headache days per month
Subject is able to differentiate migraine attacks from other headache types, if applicable
Subjects daily medications (for any indication) have remained at a stable dose for the 60 days preceding screening
Subject is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator and mutually agreed upon with patient), if female of child-bearing potential
Subjects currently taking a single agent for the prevention of migraine must be on a stable dose (unchanged for 2 months) prior to study entry
Subject has negative urine pregnancy test prior to study entry, if female of child-bearing potential
Subject is able to understand and comply with all study requirements
Subject provides written informed consent prior to any screening procedures being conducted

EXCLUSION CRITERIA:

Subjects with onset of migraine after 50 years of age
Subjects who have been previously treated or are currently being treated with duloxetine
Subjects who have failed greater than 3 adequate trials of other medications the prevention of migraine, as determined by investigator
Subjects who have a known hypersensitivity to duloxetine or any of the inactive ingredients
Subject has taken any medication which has been shown to be effective for migraine prophylaxis, on a daily basis within the 4 weeks prior to screening or at any time during participation in the study, for any indication.
Subjects with a history of significant drug or alcohol abuse within the past year
Subjects with major depressive disorder or who have had a suicidal ideation in the 3 months prior to screening or have a history of attempted suicide
Subjects who have a Beck Depression Inventory score of > 18 at screening
Subjects who have > 0 on question number 9 of Beck Depression Inventory (Suicidal Thoughts or Wishes question)
Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit
Subjects with a current or history of a hepatic or renal disorder
Subjects with uncontrolled narrow angle glaucoma
Subjects who have experienced significant side effects from two different SSRI and/or SNRI therapies, as determined by investigator
Subjects with uncontrolled restless legs syndrome, as determined by investigator
Intervention: Prednisone
Trial phase: Phase 4
ATC code: A07EA03 | H02AB07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)CC(=O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 42
Group description: Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosis of active poly-JIA as determined by International League of Associations for Rheumatology (ILAR) criteria
Onset of signs and symptoms of poly-JIA for 12 months or less prior to study screening
Willing to use acceptable forms of contraception for the duration of the study and for 3 months after the study
Parent or guardian willing to provide informed consent
Able to attend all study visits

Exclusion Criteria:

Received or currently receiving disease-modifying antirheumatic drugs (DMARDs), biologic, or prednisone for any duration for treatment of poly-JIA, with the following exceptions:

Methotrexate duration must be less than or equal to 6 weeks at a dose of less than or equal to 0.5 mg/kg/week (40 mg max),
Steroid use has been less than or equal to 4 weeks and the subject is off of steroids for at least 1 week prior to enrollment
Received intramuscular or soft-tissue injections of corticosteroids for treatment of poly-JIA before receiving the first dose of study medication. Up to 2 joint injections with intra-articular steroids (IAS) will be allowed up to 7 days after the baseline visit.
History of or active cancer of any type
Active gastrointestinal disease (e.g., inflammatory bowel disease)
Chronic or acute kidney or liver disorder
Significant blood clotting defect
AST (SGOT), ALT (SGPT), or BUN levels more than two times the upper level of normal, creatinine levels more than 1.5 mg/dl, or any other laboratory abnormality considered to be clinically significant within 28 days prior to baseline
Chronic condition (e.g., diabetes, epilepsy) that is either not stable or poorly controlled and may interfere with study participation
Received any investigational medication within 30 days prior to the first dose of study medication or scheduled to receive an investigational drug (other than the study medications) during the course of the study
Chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 30 days prior to study screening
HIV infected
Known past or current hepatitis infection
Received a live virus vaccine within 1 month prior to baseline
Purified protein derivative (PPD) positive (positive tuberculosis [TB] test)
Pregnancy
Any medical condition that would make study participation difficult or inadvisable in the opinion of the investigator
History of or current psychiatric illness that would interfere with study participation
History of alcohol or drug abuse within the 6 months prior to study entry that would interfere with study participation
Inability to comply with study requirements for any reason
Intervention: Humulin N
Trial phase: Not Applicable
ATC code: A10AE01
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(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)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: Child
Healthy volunteers: No
Participants at risk: 490
Group description: Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
Eligibility criteria:
Inclusion Criteria:

Undergoing heart surgery with cardiopulmonary bypass
Recovering in the Cardiac ICU

Exclusion Criteria:

Enrolled in another interventional clinical trial with related study outcomes
Intervention: Terbinafine
Trial phase: Phase 3
ATC code: D01AE15 | D01BA02
SMILES: CN(C/C=C/C#CC(C)(C)C)Cc1cccc2ccccc12
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 131
Group description: Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
Eligibility criteria:
Inclusion Criteria:

Male and females 12 - 75 years of age
Fungal toenail infection of one or both of the large (great) toenails
The nail infection must be due to a dermatophyte, (mixed infections dermatophyte and non-dermatophyte] are not allowed)

Exclusion Criteria:

Target foot must not have severe plantar (moccasin) tinea pedis that would require systemic therapy. Mild to moderate tinea pedis (athlete's foot) infection should be treated with terbinafine prior to baseline or at any time during the trial. Other topical treatments for athlete's foot may be recommended at the discretion of the investigator.
Subjects must not have abnormalities of the nail that could prevent a normal appearing nail if clearing of infection is achieved
No administration of systemic antifungal medications within 6 months prior to screening visit
No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
No professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit
Known pregnancy or lactation at time of enrollment

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Terbinafine
Trial phase: Phase 3
ATC code: D01AE15 | D01BA02
SMILES: CN(C/C=C/C#CC(C)(C)C)Cc1cccc2ccccc12
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 134
Group description: Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
Eligibility criteria:
Inclusion Criteria:

Male and females 12 - 75 years of age
Fungal toenail infection of one or both of the large (great) toenails
The nail infection must be due to a dermatophyte, (mixed infections dermatophyte and non-dermatophyte] are not allowed)

Exclusion Criteria:

Target foot must not have severe plantar (moccasin) tinea pedis that would require systemic therapy. Mild to moderate tinea pedis (athlete's foot) infection should be treated with terbinafine prior to baseline or at any time during the trial. Other topical treatments for athlete's foot may be recommended at the discretion of the investigator.
Subjects must not have abnormalities of the nail that could prevent a normal appearing nail if clearing of infection is achieved
No administration of systemic antifungal medications within 6 months prior to screening visit
No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
No professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit
Known pregnancy or lactation at time of enrollment

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Terbinafine
Trial phase: Phase 3
ATC code: D01AE15 | D01BA02
SMILES: CN(C/C=C/C#CC(C)(C)C)Cc1cccc2ccccc12
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 126
Group description: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
Eligibility criteria:
Inclusion Criteria:

Male and females 12 - 75 years of age
Fungal toenail infection of one or both of the large (great) toenails
The nail infection must be due to a dermatophyte, (mixed infections [dermatophyte and non-dermatophyte] are not allowed)

Exclusion Criteria:

Target foot must not have severe plantar (moccasin) tinea pedis that would require systemic therapy. Mild to moderate tinea pedis (athlete's foot) infection should be treated with terbinifine prior to baseline or at any time during the trial. Other topical treatments for athlete's foot may be recommended at the discretion of the investigator.
Subjects must not have abnormalities of the nail that could prevent a normal appearing nail if clearing of infection is achieved
No administration of systemic antifungal medications within 6 months prior to screening visit
No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
No professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit
Known pregnancy or lactation at time of enrollment

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Terbinafine
Trial phase: Phase 3
ATC code: D01AE15 | D01BA02
SMILES: CN(C/C=C/C#CC(C)(C)C)Cc1cccc2ccccc12
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 135
Group description: Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
Eligibility criteria:
Inclusion Criteria:

Male and females 12 - 75 years of age
Fungal toenail infection of one or both of the large (great) toenails
The nail infection must be due to a dermatophyte, (mixed infections [dermatophyte and non-dermatophyte] are not allowed)

Exclusion Criteria:

Target foot must not have severe plantar (moccasin) tinea pedis that would require systemic therapy. Mild to moderate tinea pedis (athlete's foot) infection should be treated with terbinifine prior to baseline or at any time during the trial. Other topical treatments for athlete's foot may be recommended at the discretion of the investigator.
Subjects must not have abnormalities of the nail that could prevent a normal appearing nail if clearing of infection is achieved
No administration of systemic antifungal medications within 6 months prior to screening visit
No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
No professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit
Known pregnancy or lactation at time of enrollment

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Mefloquine
Trial phase: Phase 4
ATC code: P01BC02 | P01BF02
SMILES: OC(c1cc(C(F)(F)F)nc2c(C(F)(F)F)cccc12)C1CCCCN1
Sex: All
Age groups: Child | Adult | Older Adult
Participants at risk: 53
Group description: Artesunate-Mefloquine
Eligibility criteria:
Inclusion Criteria

12 years of age or older
Accepts Healthy Volunteers
P. falciparum parasitemia between 1,000 and 100,000 parasites/μl
History of fever or presence of fever (temperature ≥ 37.5°C)

Exclusion Criteria

Signs/symptoms of severe/complicated malaria
Ingestion of various antimalarial drugs, or antibiotics in the previous 2 weeks to 2 months
History of any drug-related hearing impairment
Abnormal hearing function at study entry
Exposure to sustained loud noises, by self-report, within the past 24 hours
Present ear problems
Pregnant or lactating (urine test for β-HCG) to be performed on any woman of child bearing age)

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Lansoprazole
Trial phase: Phase 4
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Patients who have documented GERD as evidenced by erosive esophagitis or those patients who have newly diagnosed laryngopharyngeal reflux as diagnosed by endoscopy.

Prevacid: 30 mg bid for 3 months

Esophageal and Laryngeal Biopsies: repeat egd with biopsy
Eligibility criteria:
Inclusion Criteria:

GERD

Documented erosive esophagitis:

Patients will be newly diagnosed with esophageal erosion at initial visit via EGD
Patients with non-erosive esophagitis who have been responsive to PPI

LPR

Diagnosed via Head & Neck Institute endoscopists:

pts with chronic (> 3-months) history of hoarseness, throat clearing, sore- or burning throat and globus
Documentation of LPR using Larynx/Pharynx exam.

This group is commonly evaluated at the Vanderbilt Voice Center.

Exclusion Criteria:

Age < 18yrs
Pregnancy
Patients with contra-indications for EGD
Patients on corticosteroids
Active smokers
Patients with a history of regular (> 2 /day) alcohol use.
Use of antacid (PPI, H2RB) within last 30 days
Use of any/all medications affecting gastrointestinal motility
Known history of: Barrett's esophagus, Peptic stricture, Pyloric stenosis, Gastric resection
Patients unable to give informed consent
Patients unable to comply with follow-up
Patients with known contraindication to lansoprazole.
Contraindications to biopsy: Taking anticoagulants other than aspirin (Coumadin, Plavix) or allergic to the local anesthetics.
Intervention: Fesoterodine Fumarate
Trial phase: Phase 3
SMILES: CC(C)C(=O)Oc1ccc(CO)cc1C(CCN(C(C)C)C(C)C)c1ccccc1.O=C(O)C=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 679
Group description: Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
Eligibility criteria:
Inclusion Criteria:

Adult overactive bladder (OAB) patients who present with OAB symptoms, including urinary frequency >= 8 per day and urgency urinary incontinence >=1 per day

Exclusion Criteria:

Patients with conditions that would contraindicate for fesoterodine use, e.g, hypersensitivity to the active substance (fesoterodine) or to peanut or soya or any of the excipients, urinary retention, and gastric retention.
Patients with significant hepatic and renal disease or other significant unstable diseases.
OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
Intervention: Growth hormone
Trial phase: Phase 3
SMILES: CC(C)CC1NC(=O)C(CCC(=O)O)NC(=O)C2CSSCC3NC(=O)C(C)NC(=O)C4CCCN4C(=O)C(CC(N)=O)NC(=O)C(CSSCC(NC(=O)C(Cc4ccc(O)cc4)NC(=O)C(CC(N)=O)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(N)CC(N)=O)C(=O)N2)NC(=O)C(CSSC(C(=O)NC(Cc2ccc(O)cc2)C(=O)O)NC(=O)CNC(=O)C(C(C)O)NC3=O)NC1=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Nutropin AQ: 0.0125 mg/kg/day
Eligibility criteria:
Inclusion Criteria:

16 to 60 years old
Male or female with diagnosed Prader-Willi syndrome confirmed by genetic testing (e.g., mPCR)
Low IGF-1 level (e.g.,≤25%) at baseline
Ability to provide informed consent or availability of a suitable legally authorized representative

Exclusion Criteria:

Pregnancy
Previous treatment with growth hormone
Uncontrolled endocrine disease, (i.e. diabetes or thyroid)
History of severe scoliosis
Heart disease
Uncontrolled high blood pressure or history of stroke
Morbid obesity (using PWS growth charts)
Severe sleep apnea or known breathing difficulties/obstruction (as per history or diagnostic testing results
Intervention: Fondaparinux
Trial phase: Phase 2
ATC code: B01AX05
SMILES: CO[C@H]1O[C@H](COS(=O)(=O)O)[C@@H](O[C@@H]2O[C@@H](C(=O)O)[C@@H](O[C@H]3O[C@H](COS(=O)(=O)O)[C@@H](O[C@@H]4O[C@H](C(=O)O)[C@@H](O[C@H]5O[C@H](COS(=O)(=O)O)[C@@H](O)[C@H](O)[C@H]5NS(=O)(=O)O)[C@H](O)[C@H]4O)[C@H](OS(=O)(=O)O)[C@H]3NS(=O)(=O)O)[C@H](O)[C@H]2OS(=O)(=O)O)[C@H](O)[C@H]1NS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Intra-Aortic Balloon Pump (IABP) with Heparin

Heparin: Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP).
Eligibility criteria:
Inclusion Criteria:

Age >/= 18 years
Able to provide consent
Insertion of Intra-aortic Balloon Pump (IABP) in William Beaumont Hospital (WBH) cath lab
Anticipated duration of IABP >/= 18 hours

Exclusion Criteria:

Contraindications to heparin
Pre-existing condition requiring heparin administration (other than IABP)
IABP placed outside of the WBH cardiac catheterization lab prophylactically for high-risk percutaneous coronary intervention (PCI), without complications)
Pregnant women
Intervention: Rezatomidine
Trial phase: Phase 2
SMILES: Cc1cccc([C@H](C)c2c[nH]c(=S)[nH]2)c1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosis of fibromyalgia syndrome
Moderate or severe pain associated with fibromyalgia

Exclusion Criteria:

Any other uncontrolled disease
Pregnant or nursing females
Intervention: Pyridoxine
Trial phase: Phase 3
ATC code: A11HA02 | J04AM08
SMILES: Cc1ncc(CO)c(CO)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 389
Group description: 100 mg twice per day

Pyridoxine: 100mg BID/daily, Per oral
Eligibility criteria:
Inclusion Criteria:

Gastrointestinal tract cancer patients treated with capecitabine-containing chemotherapy as a first-line treatment were randomly allocated to concurrent treatment with pyridoxine or placebo.
All patients were 18 to 70 years old
Had Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
An estimated life expectancy > 3 months
Adequate bone marrow function, including white blood cell (WBC) count of >3500 cells/㎕ and platelet count of >100000/㎕
Adequate renal function (serum creatinine concentration <1.5 mg/㎗)
Adequate liver function with (serum bilirubin concentration <1.5 mg/㎗, transaminase <3 times the upper normal limit, and serum albumin >2.5 mg/㎗).

Exclusion Criteria:

Previous treatment for HFS
Hypersensitivity to pyridoxine
A combination of other malignancies
Serious illnesses or medical conditions
Immune suppression or positive human immunodeficiency virus (HIV) serology
Pregnant or lactating women.