anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Betamethasone
Trial phase: Phase 2
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: 700 µg dexamethasone implant in the study eye at Day 1
Eligibility criteria:
Inclusion Criteria:

18 years of age or older with diabetic macular edema
History of vitrectomy
Central retinal thickness ≥ 275 µm
Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye

Exclusion Criteria:

Known anticipated need for ocular surgery during the study period
History of glaucoma or current high eye pressure requiring more than 1 medication
Uncontrolled systemic disease
Known allergy to the study medication
Known steroid-responder
Use of systemic steroids
Female subjects that are pregnant, nursing or planning a pregnancy
Intervention: Clevidipine
Trial phase: Phase 2
ATC code: C08CA16
SMILES: CCCC(=O)OCOC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1c1cccc(Cl)c1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Study participants were sequentially assigned one of three cohorts to receive either a 250 μg, 500 μg or 125 μg bolus dose of clevidipine during Treatment Period 1 prior to induction of general anesthesia (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds). At the discretion of the investigator, a second bolus could be administered during Treatment Period 2 after induction of general anesthesia (Bolus 2 - with anesthesia) at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1.
Eligibility criteria:
Inclusion Criteria:

Require elective cardiac operation involving the use of cardiopulmonary bypass
Age 18 years or older
A history or hypertension and/or expected to require perioperative antihypertensive therapy in the opinion of the investigator
Written informed consent
Pre-anesthesia baseline SBP ≥140 mm Hg just prior to bolus, measured using an arterial line

Exclusion Criteria:

Receiving either intravenous vasopressor or intravenous vasodilatory therapy in the 72 hours prior to dosing
Critical left main coronary artery stenosis
Critical aortic valve (<0.5 cm3) or mitral valve (<1.0 cm3) stenosis
Acute myocardial infarction within the prior 14 days
Fully paced cardiac rhythm
Known or suspected aortic dissection
Requiring preoperative intra-aortic balloon pump counterpulsation therapy
Contraindication to transesophageal echocardiography
Positive pregnancy test or breast feeding
Intolerance or allergy to calcium channel blockers
Allergy to soybean oil or egg lecithin
Any condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the patient from completing the study
Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment
Intervention: CID 12303048
Trial phase: Phase 3
ATC code: S03AA04
SMILES: NC(=NCCCCCCN=C(N)N=C(N)Nc1ccc(Cl)cc1)N=C(N)Nc1ccc(Cl)cc1.O=C(O)C(O)C(O)C(O)C(O)CO.O=C(O)C(O)C(O)C(O)C(O)CO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 335
Group description: Chlorhexidine gluconate 4% w/v in an aqueous base

Aqueous CHG 4% w/v applied according to manufacturer's directions: Step 1) 5 mL of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated.
Eligibility criteria:
Inclusion Criteria:

Subjects must read and sign an Informed Consent Form and be cooperative.
Subjects must be in good general health.
Subjects must have skin within 6 inches of the test site that is free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorders.

Exclusion Criteria:

Use of systemic or topical antimicrobials during the 2-week pretest conditioning period. This restriction includes but is not limited to shampoos, lotions, soaps, baby powders, and materials, such as solvents, acids, or alkalis.
A medical diagnosis of a physical condition, which would preclude participation such as: diabetes, hepatitis, an organ transplant, a medical surgical implant, or an immunocompromised system.
Any medical condition that in the opinion of the investigator would preclude participation.
Bathed in chemically treated pools or hot tubs 2 weeks prior to any microbial sampling.
Used UV tanning lamps 2 weeks prior to any microbial sampling.
Bathing or showering less than 48 hours prior to any microbial sampling.
Known sensitivity to chlorhexidine gluconate.
Known sensitivity to latex (rubber).
Known sensitivity to fragrances.
Pregnant or nursing.
Unwillingness to fulfill the performance requirements of the study.
Subjects who have completed part or all of the study will not be reentered in the study.
Intervention: Tofogliflozin
Trial phase: Phase 2
SMILES: CCc1ccc(Cc2ccc3c(c2)[C@]2(OC3)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 2.5 mg of RO4998452.
Eligibility criteria:
Inclusion Criteria:

adult patients, 18-75 years of age;
type 2 diabetes, diagnosed for >=3 months;
either treated with diet, exercise and stable metformin, or with diet and exercise alone.

Exclusion Criteria:

type 1 diabetes mellitus;
currently or within 2 months prior to screening treated with an oral or injectable anti-diabetic agent except stable doses of metformin;
currently or within 6 months prior to screening treated with any PPARgamma agonist;
uncontrolled hypertension;
significant pre-diagnosed diabetic complications requiring treatment.
Intervention: Tofogliflozin
Trial phase: Phase 2
SMILES: CCc1ccc(Cc2ccc3c(c2)[C@]2(OC3)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 65
Group description: During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 5 mg of RO4998452.
Eligibility criteria:
Inclusion Criteria:

adult patients, 18-75 years of age;
type 2 diabetes, diagnosed for >=3 months;
either treated with diet, exercise and stable metformin, or with diet and exercise alone.

Exclusion Criteria:

type 1 diabetes mellitus;
currently or within 2 months prior to screening treated with an oral or injectable anti-diabetic agent except stable doses of metformin;
currently or within 6 months prior to screening treated with any PPARgamma agonist;
uncontrolled hypertension;
significant pre-diagnosed diabetic complications requiring treatment.
Intervention: Tofogliflozin
Trial phase: Phase 2
SMILES: CCc1ccc(Cc2ccc3c(c2)[C@]2(OC3)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 10 mg of RO4998452.
Eligibility criteria:
Inclusion Criteria:

adult patients, 18-75 years of age;
type 2 diabetes, diagnosed for >=3 months;
either treated with diet, exercise and stable metformin, or with diet and exercise alone.

Exclusion Criteria:

type 1 diabetes mellitus;
currently or within 2 months prior to screening treated with an oral or injectable anti-diabetic agent except stable doses of metformin;
currently or within 6 months prior to screening treated with any PPARgamma agonist;
uncontrolled hypertension;
significant pre-diagnosed diabetic complications requiring treatment.
Intervention: Tofogliflozin
Trial phase: Phase 2
SMILES: CCc1ccc(Cc2ccc3c(c2)[C@]2(OC3)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 20 mg of RO4998452.
Eligibility criteria:
Inclusion Criteria:

adult patients, 18-75 years of age;
type 2 diabetes, diagnosed for >=3 months;
either treated with diet, exercise and stable metformin, or with diet and exercise alone.

Exclusion Criteria:

type 1 diabetes mellitus;
currently or within 2 months prior to screening treated with an oral or injectable anti-diabetic agent except stable doses of metformin;
currently or within 6 months prior to screening treated with any PPARgamma agonist;
uncontrolled hypertension;
significant pre-diagnosed diabetic complications requiring treatment.
Intervention: Tofogliflozin
Trial phase: Phase 2
SMILES: CCc1ccc(Cc2ccc3c(c2)[C@]2(OC3)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: During the single-blind run-in period, two placebo capsules were taken in the morning approximately 15 minutes prior to breakfast. During the 12-week double-blind treatment period, two capsules were taken in the morning approximately 15 minutes prior to breakfast, except on the days of the meal tolerance test. The two capsules combined contained 40 mg of RO4998452.
Eligibility criteria:
Inclusion Criteria:

adult patients, 18-75 years of age;
type 2 diabetes, diagnosed for >=3 months;
either treated with diet, exercise and stable metformin, or with diet and exercise alone.

Exclusion Criteria:

type 1 diabetes mellitus;
currently or within 2 months prior to screening treated with an oral or injectable anti-diabetic agent except stable doses of metformin;
currently or within 6 months prior to screening treated with any PPARgamma agonist;
uncontrolled hypertension;
significant pre-diagnosed diabetic complications requiring treatment.
Intervention: Augmentin
Trial phase: Not Applicable
SMILES: CC1(C)SC2C(NC(=O)C(N)c3ccc(O)cc3)C(=O)N2C1C(=O)O.O=C([O-])C1C(=CCO)OC2CC(=O)N21.[K+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 276
Group description: Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
Eligibility criteria:
Inclusion Criteria:

surgical patient
clean or clean-contaminated surgery

Exclusion Criteria:

infection
preoperative antibiotic treatment
postoperative antibiotic treatment
open fractures
Intervention: Budesonide
Trial phase: Phase 3
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.

Budesonide MMX 6 mg Tablet: Budesonide MMX 6 mg Tablet once daily.
Eligibility criteria:
Inclusion Criteria:

Patients fulfilling the following criteria are eligible for participation in the study:

Male and female patients, 18-75 years old, who are able to understand and voluntarily provide written informed consent.
Patients in UCDAI remission defined as a UCDAI score ≤ 1 point with a score of 0 for rectal bleeding and stool frequency, and a ≥ 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability (score 0 for mucosal appearance).
Patients who have completed all End of Study assessments for the CB-01-02/01, CB-01-02/02 and CB-01-02/06 studies.
Females of child-bearing potential must have had a serum pregnancy test performed at the End of Study visit of the parent studies and must use an acceptable contraceptive method throughout the study treatment period.

Exclusion Criteria:

Patients who meet any of the following criteria at screening visit are to be excluded from study participation:

Subjects who have withdrawn from studies CB-01-02/01, CB 01 02/02 or CB-01-02/06.
Subjects who did not achieve induction of remission according to the primary endpoint definition in studies CB-01-02/01, CB 01 02/02 or CB-01-02/06 (i.e. clinical remission defined as a UCDAI score ≤ 1 point with a score of 0 for rectal bleeding and stool frequency, and ≥ 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability [score 0 for mucosal appearance]).
Subjects with bone density lower than normal by age and sex (T-score lower than -1) as assessed via dual energy X-ray absorptiometry (DXA) scans.
Intervention: Fluorine-18
Trial phase: Phase 1
SMILES: F
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET) scans of their brains using F-18 (fallypride), a dopamine type 2 (DA D2) receptor radioligand whose binding is sensitive to competition with endogenous dopamine, before and after the operation.

F-18 (fallypride): Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET)scans of their brains using the radioligand fallypride before and after the operation.
Eligibility criteria:
Inclusion Criteria:

Ages 18-60 years
BMI equal to or greater than 40, or equal to or greater than 35 if there are 2 or more co-morbidities
Weight less than 350 pounds

Exclusion Criteria:

History of substance abuse,including but not limited to alcohol, cocaine, marijuana, heroin, nicotine
History of psychiatric disorders
Use of any antidepressants or psychotropics in the past 12 months
Diabetes Mellitis
Positive pregnancy test
Any condition felt by the PI or co-investigators to interfere with the individual's ability to complete the study
Subjects on medications for the last 3 months, such as sibutramine, which could affect the quality of the study, as determined by the PI
Inability to travel to Nashville, TN four times
Intervention: Methylprednisolone
Trial phase: Phase 2 | Phase 3
ATC code: D07AA01 | D07CA02 | D10AA02 | H02AB04 | H02BX01 | S01CA08 | S03CA07
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])C[C@H](C)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Methylprednisolone: 2 transtympanic injections at interval of two weeks.
Eligibility criteria:
Inclusion Criteria:

Patients with unilateral Ménière's disease (definite or probable, according to Committee on Hearing and Equilibrium guidelines, 1995) with hearing loss and presenting with recurrent vertigo, not responding to medical treatment for at least 6 months will be included. There should be normal, age appropriate hearing in the contralateral ear.

Exclusion Criteria:

Patients with Ménière's disease in later stages (not having vertigo attacks).
Age: patients older than 70 years at the start of the trial.
Severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow up.
Active additional neuro-otological disorders that may mimic Ménière's disease (e.g. vestibular migraine, vertebro-basilar TIAs, acoustic neuroma) and thus will make the objective follow up difficult.
Concurrent ear pathology that may interfere with transtympanic treatment (e.g. active middle ear disease).
Family history of unexplained deafness (possibility of genetic susceptibility to gentamicin toxicity).
History of known adverse/allergic reaction to steroids or gentamicin.
Intervention: Gentamicin
Trial phase: Phase 2 | Phase 3
ATC code: D06AX07 | J01GB03 | S01AA11 | S02AA14 | S03AA06
SMILES: CNC(C)C1CCC(N)C(OC2C(N)CC(N)C(OC3OCC(C)(O)C(NC)C3O)C2O)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
Eligibility criteria:
Inclusion Criteria:

Patients with unilateral Ménière's disease (definite or probable, according to Committee on Hearing and Equilibrium guidelines, 1995) with hearing loss and presenting with recurrent vertigo, not responding to medical treatment for at least 6 months will be included. There should be normal, age appropriate hearing in the contralateral ear.

Exclusion Criteria:

Patients with Ménière's disease in later stages (not having vertigo attacks).
Age: patients older than 70 years at the start of the trial.
Severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow up.
Active additional neuro-otological disorders that may mimic Ménière's disease (e.g. vestibular migraine, vertebro-basilar TIAs, acoustic neuroma) and thus will make the objective follow up difficult.
Concurrent ear pathology that may interfere with transtympanic treatment (e.g. active middle ear disease).
Family history of unexplained deafness (possibility of genetic susceptibility to gentamicin toxicity).
History of known adverse/allergic reaction to steroids or gentamicin.
Intervention: Ciclopirox Olamine
Trial phase: Phase 3
SMILES: Cc1cc(C2CCCCC2)n(O)c(=O)c1.NCCO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 224
Group description: Ciclopirox Olamine Cream, USP
Eligibility criteria:
Inclusion Criteria:

Male or female at least 10 years of age, and otherwise healthy
Clinically and mycologically confirmed diagnosis of symptomatic tinea pedis
In good health with no clinically significant disease that might have interfered with study evaluations
Study participant or legal guardian was willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol. For subjects 10 to 17 years of age, an assent form for minors was completed.

Exclusion Criteria:

History of hypersensitivity or allergy to ciclopirox
Had any skin condition that would interfere with the diagnosis or assessment of tinea pedis
Had a history of dermatophyte infecton unresponsive to antifungal treatment
Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
Was unwilling to sign the informed consent
Female who was pregnant or lactating
Intervention: Ciclopirox
Trial phase: Phase 3
ATC code: D01AE14 | G01AX12
SMILES: Cc1cc(C2CCCCC2)n(O)c(=O)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 226
Group description: Loprox® (ciclopirox) Cream 0.77%
Eligibility criteria:
Inclusion Criteria:

Male or female at least 10 years of age, and otherwise healthy
Clinically and mycologically confirmed diagnosis of symptomatic tinea pedis
In good health with no clinically significant disease that might have interfered with study evaluations
Study participant or legal guardian was willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol. For subjects 10 to 17 years of age, an assent form for minors was completed.

Exclusion Criteria:

History of hypersensitivity or allergy to ciclopirox
Had any skin condition that would interfere with the diagnosis or assessment of tinea pedis
Had a history of dermatophyte infecton unresponsive to antifungal treatment
Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
Was unwilling to sign the informed consent
Female who was pregnant or lactating
Intervention: Varenicline
Trial phase: Phase 4
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Varenicline 1-2 mg/day

Varenicline: Varenicline 1-2 mg/day
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Schizophrenia or Schizoaffective Disorder Current Cigarette Smoker or History of Chronic Cigarette smoking Age 18-65 Currently taking antipsychotic medication

Exclusion Criteria:

prior history of hospitalization for acute myocardial infarction or stroke, or persistent angina pectoris with current symptoms Patients who have previously tried varenicline and have stopped taking it because of side-effects of severe nausea or vomiting suicide attempt in the last year and or have had prominent or serious suicidal thoughts in the past year Women who are pregnant, nursing, or unable to use reliable contraception significant renal impairment(Creatinine ≥ 1.5) baseline Hamilton Depression Scores is >20
Intervention: Teriflunomide
Trial phase: Phase 3
ATC code: L04AA31
SMILES: C/C(O)=C(\C#N)C(=O)Nc1ccc(C(F)(F)F)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 129
Group description: Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
Eligibility criteria:
Inclusion Criteria:

Participant who completed the previous double-blind placebo-controlled study EFC6049 and who did not meet criteria for treatment withdrawal.
Willingness to participate in a long-term safety/efficacy trial.

Exclusion Criteria:

Any known condition or circumstance that would prevent in the investigator's opinion, compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.