anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Roflumilast
Trial phase: Phase 4
ATC code: R03DX07
SMILES: O=C(Nc1c(Cl)cncc1Cl)c1ccc(OC(F)F)c(OCC2CC2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1178
Group description: Roflumilast 500 µg, oral administration, once per day
Eligibility criteria:
Inclusion Criteria:

1. Male or female patients at least 40 years of age
2. History of COPD (according to Global Initiative for Chronic Obstructive Lung Disease [GOLD] 2010) for at least 12 months prior to Screening (Visit 1) associated with chronic productive cough for 3 months in each of 2 consecutive years (with other causes of productive cough excluded). Only patients with chronic bronchitis will be included (concomitant emphysema is permitted)
3. Forced expiratory volume after 1 second (FEV1)/forced vital capacity (FVC) ratio (postbronchodilator) < 70% at Screening (Visit 1)
4. FEV1 (postbronchodilator) ≤ 50% of predicted at Screening (Visit 1)
5. At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 1)
6. Patients must be on FDC LABA/ICS treatment ≥ 3 months prior to Screening (Visit 1)
7. Former smokers (defined as smoking cessation at least 1 year ago) or current smokers (including patients who ceased smoking within the past year) both with a smoking history of at least 20 pack-years

Exclusion Criteria:

1. Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics or systemic glucocorticosteroids within 4 weeks of Screening (Visit 1) (ie, patients must be clinically stable)
2. Known alpha-1-antitrypsin deficiency
3. Current diagnosis of asthma (either controlled or uncontrolled) (Note: History of childhood asthma is not exclusionary.)
4. Body mass index (BMI) ≥ 45 kg/m2
5. Patients with a history (within 5 years) or current diagnosis of cancer other than basal or squamous cell skin cancer
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: Child
Healthy volunteers: No
Participants at risk: 108
Group description: Entocort™ EC 9/6/3 mg
Eligibility criteria:
Inclusion Criteria:

All male and female subjects must be aged 5 to 17, inclusive, and must not have reached their 18th birthday by the estimated final office visit.
Subject must be diagnosed with active Crohn's disease of the ileum and/or ascending colon confirmed by endoscopic and/or radiographic evidence, and/or evidence of mucosal erosions and/or histology.
Subjects with mild to moderate Crohn's disease.
All subjects must have a stool analysis negative for Clostridium difficile toxin, Yersinia enterolytica, Campylobacter jejuni, Salmonella, Shigella, within the 30 days prior to visit 1.
All subjects must have had laboratory assessments within 7 days prior to visit 1.
All subjects must weigh >= 15 kg at time of enrollment

Exclusion Criteria:

Subjects who have had any previous intestinal resection proximal to and including the ascending colon
Subjects with evidence of severe active Crohn's disease and/or, stricturing and prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications
Subjects who do not have a negative stool analysis, within the 30 days prior to visit 1
Subjects who have been screened/or enrolled in this study previously within the last 30 days
Subjects with morning cortisol level <150 nmol/l (5.4 ug/dl) or DHEA-S below normal range for age and gender
Intervention: Dalfampridine
Trial phase: Phase 2
ATC code: N07XX07
SMILES: Nc1ccncc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Dalfampridine: 10mg, twice daily, pill taken by mouth for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Age 20- 59 years,
Able to walk at least 100m without an aide or with unilateral assistance
Prolonged APR latencies (≥ 1SD > mean for healthy people in this age range) OR,
Reduced balance-related activity (ABC scores ≤ 85%),
Abnormal trunk range of motion (horizontal), trunk range of motion (frontal), turning duration, cadence, double support time, stride length or gait cycle time (outside 1SD of the average for healthy people in this age range)

Exclusion Criteria:

Currently taking dalfampridine (any within the last 2 weeks),
Cause(s) of imbalance other than MS,
Impaired renal function (creatinine clearance ≤50mL/min),
Seizure disorder
Pregnancy or breast feeding
Intervention: EXENATIDE
Trial phase: Not Applicable
ATC code: A10BJ01
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(N)=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 10
Group description: All subjects enrolled in this study will be given Exenatide for 6 months.

Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months).
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Prader Willi Syndrome confirmed by genetic testing (DNA methylation or FISH)
Ages 13-20 years
body mass index (BMI) > 85th percentile for age and gender

Exclusion Criteria:

Is currently using or has previously used a glucagon-like peptide-1 (GLP-1) agonist
History of pancreatitis, or renal failure
History of familial pancreatitis
Amylase, or lipase levels > 2.5 times the upper limit of normal any time in the previous 2 years
Creatinine clearance < 30 mL/min
Other syndromic diagnoses
gastrointestinal (GI) or renal illness in the 1 month prior to entering study
Inability to take study drug
Pregnancy
Initiation of growth hormone (GH), estrogen, or testosterone or change > 25% of dose/kg/day during the 6 months prior to starting study
Non-English speaking
Intervention: Meropenem
Trial phase: Phase 3
ATC code: J01DH02 | J01DH52
SMILES: [H][C@]12[C@@H](C)C(S[C@@H]3CN[C@H](C(=O)N(C)C)C3)=C(C(=O)O)N1C(=O)[C@]2([H])[C@@H](C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 497
Group description: Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
Eligibility criteria:
Inclusion Criteria:

Diagnoses of cIAI.
Subject requires surgical intervention (e.g., laparotomy, laparoscopic surgery, or percutaneous draining of an abscess) within 24 hours of (before or after) the first dose of study drug.

Exclusion Criteria:

Simple appendicitis; acute suppurative cholangitis; infected necrotizing pancreatitis; pancreatic abscess; or pelvic infections.
Complicated intraabdominal infection managed by staged abdominal repair (STAR), open abdomen technique including temporary closure of the abdomen, or any situation where infection source control is not likely to be achieved.
Use of systemic antibiotic therapy for IAI for more than 24 hours prior to the first dose of study drug, unless there is a documented treatment failure with such therapy.
Have a concomitant infection at the time of randomization, which requires non-study systemic antibacterial therapy in addition to IV study drug therapy. (Drugs with only gram-positive activity [e.g., daptomycin, vancomycin, linezolid] are allowed).
Severe impairment of renal function (estimated CrCl < 30 mL/min), or requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (< 20 mL/h urine output over 24 hours).
The presence of hepatic disease at baseline.
Considered unlikely to survive the 4 to 5 week study period.
Any rapidly-progressing disease or immediately life-threatening illness (including respiratory failure and septic shock).
Have a documented history of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibacterial (a history of a mild rash followed by uneventful re-exposure is not a contraindication to enrollment), including cephalosporins, carbapenems, penicillins, or ß-lactamase inhibitors, or metronidazole, or nitroimidazole derivatives.
Women who are pregnant or nursing.
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Lidocaine group received 1 ml/10 kg (or 1mg/kg) bolus once inhalational gas (Desflurane) is discontinued
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesia score are I or II
Undergo for laparoscopic cholecystectomy

Exclusion Criteria:

Patient's refusal
History of upper respiratory tract infection (URTI) within 2 weeks
Persistent type of hyper-reactive airway or asthma
History of airway surgery
History of gastro-esophageal reflex disease (GERD)
Currently receiving sedating or analgesic medication

Currently receiving the following medications:

Fluvoxamine
Erythromycin and Itraconazole
β -blocker or Cimetidine
History of Lidocaine Allergy
History of epilepsy disorder
Pregnant or breastfeeding women
History of Heavy Smoking ( a smoker with a daily cigarettes consumption of more than 20 pieces
History of increased salivation by a disease or medication
History of difficult intubation
Two or more attempts of intubation
Intervention: Calcipotriol
Trial phase: Phase 2 | Phase 3
ATC code: D05AX02 | D05AX52
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@@H](O)C3CC3)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 33
Group description: Calcipotriol Solution: The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Nail psoriasis of the matrix and/or of the nail bed in at least one fingernail.
Good general health.
Agreement to avoid pregnancy for the study duration

Exclusion Criteria:

Concomitant topical treatment (corticosteroids), phototherapy, or any systemic treatment (retinoids, cyclosporine, methotrexate, systemic corticosteroids and biological agents) that could affect nail psoriasis.
Patients with severe hepatic or renal disorders.
Lactating, pregnant or planning pregnancy
Unwillingness to comply with study protocol.
A history of sensitivity to indigo naturalis. -
Intervention: (1S,4R)-4-hydroxy-2,2-dimethyl-4-[5-(3-methyl-5-{[4-(trifluoromethyl)pyrimidin-2-yl]amino}phenyl)-1,3-thiazol-2-yl]cyclohexanecarboxylic acid
Trial phase: Phase 1
SMILES: Cc1cc(Nc2nccc(C(F)(F)F)n2)cc(-c2cnc(C3(O)CCC(C(=O)O)C(C)(C)C3)s2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Participants received MK-8457 100 mg BID for 10 days
Eligibility criteria:
Inclusion Criteria:

If female, must be of non-childbearing potential
If male with female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
Body mass index (BMI) ≤35 kg/m^2
Mild-to-moderate hypertension requiring treatment with one or more antihypertensive agents
Receiving stable treatment for hypertension for at least 8 weeks prior to the start of dosing and continuing therapy for duration of study
No clinically significant arrhythmias or clinically significant abnormality on electrocardiogram
Nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

Any illness that might confound the results of the study or poses an additional risk
History of stroke, chronic seizures, or major neurological disorder
Clinically significant endocrine, gastrointestinal, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
Clinically significant cardiovascular disease or has active angina
History of malignant neoplastic disease
Taking 325 mg aspirin daily
Taking 3 or more medications for the treatment of hypertension
Unable to refrain from or anticipates the use of any non-steroidal anti-inflammatory drugs (NSAIDs)
Consumes excessive amounts of alcohol and/or coffee, tea, cola, or other caffeinated beverages
Has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 4 weeks
Significant multiple and/or severe allergies
Regular user of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 2 years
Intervention: Chlorhexidine
Trial phase: Phase 2 | Phase 3
ATC code: A01AB03 | B05CA02 | D08AC02 | D08AC52 | D09AA12 | R02AA05 | S01AX09 | S02AA09 | S03AA04
SMILES: N=C(NCCCCCCNC(=N)NC(=N)Nc1ccc(Cl)cc1)NC(=N)Nc1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: -Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution
Eligibility criteria:
Inclusion Criteria:

Patients with lung lesions undergoing anatomic resection (lobectomy/segmentectomy/bilobectomy/pulmonary sleeve resection/pneumonectomy)
Patients with poor lung function (FEV1% <50% or DLCO<50% predicted or home oxygen requirement) and lung lesions undergoing non-anatomic lung resection (i.e. wedge resection).
Patients undergoing esophageal resection.

Exclusion Criteria:

Patients with ongoing symptomatic dental infections.
Patients with recent/ongoing pneumonia (<15 days from initial surgical patient evaluation).
Patients who've received a therapeutic course of antibiotics within 15 days prior to thoracic surgery.
Patients with a preexisting tracheostomy.
Age<18
Patients with an allergy to Peridex/chlorhexidine solution
Intervention: Chlorhexidine
Trial phase: Phase 2 | Phase 3
ATC code: A01AB03 | B05CA02 | D08AC02 | D08AC52 | D09AA12 | R02AA05 | S01AX09 | S02AA09 | S03AA04
SMILES: N=C(NCCCCCCNC(=N)NC(=N)Nc1ccc(Cl)cc1)NC(=N)Nc1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution
The intensive toothbrushing regimen and chlorhexidine mouthwash will be continued for the duration of the hospitalization or a minimum of 5 days postoperatively in the study group.
Eligibility criteria:
Inclusion Criteria:

Patients with lung lesions undergoing anatomic resection (lobectomy/segmentectomy/bilobectomy/pulmonary sleeve resection/pneumonectomy)
Patients with poor lung function (FEV1% <50% or DLCO<50% predicted or home oxygen requirement) and lung lesions undergoing non-anatomic lung resection (i.e. wedge resection).
Patients undergoing esophageal resection.

Exclusion Criteria:

Patients with ongoing symptomatic dental infections.
Patients with recent/ongoing pneumonia (<15 days from initial surgical patient evaluation).
Patients who've received a therapeutic course of antibiotics within 15 days prior to thoracic surgery.
Patients with a preexisting tracheostomy.
Age<18
Patients with an allergy to Peridex/chlorhexidine solution
Intervention: Chlorhexidine
Trial phase: Phase 2 | Phase 3
ATC code: A01AB03 | B05CA02 | D08AC02 | D08AC52 | D09AA12 | R02AA05 | S01AX09 | S02AA09 | S03AA04
SMILES: N=C(NCCCCCCNC(=N)NC(=N)Nc1ccc(Cl)cc1)NC(=N)Nc1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution
The intensive toothbrushing regimen and chlorhexidine mouthwash will be continued for the duration of the hospitalization or a minimum of 5 days postoperatively in the study group.
Eligibility criteria:
Inclusion Criteria:

Patients with lung lesions undergoing anatomic resection (lobectomy/segmentectomy/bilobectomy/pulmonary sleeve resection/pneumonectomy)
Patients with poor lung function (FEV1% <50% or DLCO<50% predicted or home oxygen requirement) and lung lesions undergoing non-anatomic lung resection (i.e. wedge resection).
Patients undergoing esophageal resection.

Exclusion Criteria:

Patients with ongoing symptomatic dental infections.
Patients with recent/ongoing pneumonia (<15 days from initial surgical patient evaluation).
Patients who've received a therapeutic course of antibiotics within 15 days prior to thoracic surgery.
Patients with a preexisting tracheostomy.
Age<18
Patients with an allergy to Peridex/chlorhexidine solution
Intervention: Fluorometholone
Trial phase: Phase 2
ATC code: C05AA06 | D07AB06 | D07CB03 | D07XB04 | D10AA01 | S01BA07 | S01BB03 | S01CA07 | S01CB05
SMILES: [H][C@@]12CC[C@](O)(C(C)=O)[C@@]1(C)C[C@H](O)[C@@]1(F)[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: 130
Group description: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.

Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.
Eligibility criteria:
INCLUSION CRITERIA: The following are requirements for inclusion in the study:

Male or female patient, at least 18 years of age, who is a candidate for DMEK due to corneal endothelial dysfunction or who has undergone DMEK within the last 7 weeks
Patient is able and willing to administer eye drops.
Patient is able to comprehend and has signed the Informed Consent form.
Patient is likely to complete the entire one-year course of the study.
Patient has best corrected visual acuity (BCVA) of at least 20/200 in the fellow eye.
Corneal neovascularization will not be judged as an exclusion criteria for the study

EXCLUSION CRITERIA: The following are exclusion criteria for patients in this study:

A patient with a previous failed graft in the study eye with a history of a prior rejection episode
A patient exhibiting any intraocular inflammation
A patient with a known sensitivity to any of the ingredients in the study medications
A patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
A patient with abnormal eyelid function
A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis
A patient with the presence of any ocular disease that would interfere with the evaluation of the study treatment
A patient with a history of non-compliance with using prescribed medication
A patient who is concurrently involved in or participated in another clinical trial within 30 days prior to enrollment in this study.
Intervention: PREDNISOLONE ACETATE
Trial phase: Phase 2
SMILES: CC(=O)OCC(=O)C1(O)CCC2C3CCC4=CC(=O)C=CC4(C)C3C(O)CC21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 134
Group description: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.

Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.
Eligibility criteria:
INCLUSION CRITERIA: The following are requirements for inclusion in the study:

Male or female patient, at least 18 years of age, who is a candidate for DMEK due to corneal endothelial dysfunction or who has undergone DMEK within the last 7 weeks
Patient is able and willing to administer eye drops.
Patient is able to comprehend and has signed the Informed Consent form.
Patient is likely to complete the entire one-year course of the study.
Patient has best corrected visual acuity (BCVA) of at least 20/200 in the fellow eye.
Corneal neovascularization will not be judged as an exclusion criteria for the study

EXCLUSION CRITERIA: The following are exclusion criteria for patients in this study:

A patient with a previous failed graft in the study eye with a history of a prior rejection episode
A patient exhibiting any intraocular inflammation
A patient with a known sensitivity to any of the ingredients in the study medications
A patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
A patient with abnormal eyelid function
A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis
A patient with the presence of any ocular disease that would interfere with the evaluation of the study treatment
A patient with a history of non-compliance with using prescribed medication
A patient who is concurrently involved in or participated in another clinical trial within 30 days prior to enrollment in this study.
Intervention: Bimatoprost
Trial phase: Phase 4
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
Eligibility criteria:
Inclusion Criteria:

Have inadequate eyelashes
Never used prescription eyelash growth products

Exclusion Criteria:

No visible eyelashes
Permanent eyeliner or eyelash implants
Semi-permanent eyelash tint, dye, or extensions within 3 months
Over-the-counter eyelash growth products within 6 months
Any disease, infection or abnormality of the eye or area around the eye
Eye surgery within 3 months, or the anticipated need for eye surgery during the study
Unable or unwilling to keep contact lenses out during drug application and for 30 minutes after application