anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Azithromycin
Trial phase: Phase 2 | Phase 3
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 101
Group description: Participants orally received azithromycin 10mg/kg/day for 7 days; then oral azithromycin 5mg/kg/day for 7 additional days
Eligibility criteria:
Inclusion Criteria:

Age: 1-18 months.
Hospitalization for the first episode of RSV bronchiolitis.
Confirmed RSV infection by positive nasal swab results (PCR assay and/or direct antigen detection).
At least two of the following symptoms/signs of bronchiolitis: respiratory rate greater than 40 breaths/minute; cough; wheezing; audible rales, crackles, and/or rhonchi; paradoxical chest movements (retractions)28.
Duration of respiratory symptoms from onset of symptoms of the current illness to admission is 120 hours (5 days) or less.
Randomization can be performed within 168 hours (7 days) from onset of symptoms.
Willingness to provide informed consent by the child's parent or guardian.

Exclusion Criteria:

Prematurity (gestational age < 36 weeks).
Presence or history of other significant disease (CNS, lung, cardiac, renal, GI, hepatic disease, hematologic, endocrine or immune disease). Children with atopic dermatitis and/or food allergy will not be excluded from the study.
Clinically significant gastroesophageal reflux currently treated with a daily anti-reflux medication (anti- H2 or PPI).
The child has significant developmental delay/failure to thrive, defined as weight < 3% for age and gender.
History of previous (before the current episode) wheeze or previous (before the current episode) treatment with albuterol.
History of previous treatment with corticosteroid (systemic or inhaled) for respiratory issues.
Treatment (past or present) with montelukast.
Treatment with any macrolide antibiotic (azithromycin, clarithromycin or erythromycin) over the past 4 weeks or current treatment with any macrolide antibiotic. Current or prior treatment with non-macrolide antibiotic is not an exclusion criterion.
Chronic treatment with any daily medication other than vitamins or nutritional supplements. Although routine vitamin D supplement (400 IU per day) is not an exclusion criterion, high dose vitamin D supplements are not allowed.
Participation in another clinical trial.
Participant requires invasive mechanical ventilation due to RSV bronchiolitis.
Evidence that the family may be unreliable or non-adherent, or has definitive plans to move from the clinical center area before trial completion.
Contraindication of use of azithromycin or any other macrolide antibiotics such as history of allergic reaction (or other adverse reaction) to these antibiotics.
Diagnosis of asthma.
Treatment with other medication that may cause QT interval prolongation.
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Participants will receive IV lidocaine (75 mg if <50kg, 100 mg if 50 - 100 kg, and 150 mg if >100 kg) over 10 minutes in a 100 mL normal saline minibag followed by a 50 minute IV lidocaine drip (75 mg if <50kg, 100 mg if 50 - 100 kg, and 150 mg if >100 kg) in a 100 mL normal saline minibag.

At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.

Intravenous lidocaine: Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes
Eligibility criteria:
Inclusion Criteria:

Subject has severe pain (NRS ≥7)
Subject has anticipated ED stay of ≥1 hour

Exclusion Criteria:

High acuity trauma patients
Patients deemed to critically ill by ED provider
Active psychosis
Pregnancy
History of heart block or bradycardia
Allergy to lidocaine or amide type local anesthetic
History of seizures
Intervention: Carbamazepine
Trial phase: Phase 4
ATC code: N03AF01
SMILES: NC(=O)N1c2ccccc2C=Cc2ccccc21
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: Carbamazepine (400mg twice daily).
Eligibility criteria:
Inclusion Criteria:

Healthy adults between the ages of 18 and 55 years old.
Male or female

Exclusion Criteria:

Presence of clinically significant cardiovascular, endocrine, hematopoietic, hepatic, neurologic, psychiatric, or renal disease or pregnancy.
Presence or history of drug or alcohol abuse.
The use of concomitant medications, which are known to affect ESL or Carbamazepine or the use of any concomitant medications that may alter cognitive function (see Section VII.E for a partial list).
Use of oral contraceptive hormones or other medications that could be affected by ESL or Carbamazepine.
Prior adverse reaction to or prior hypersensitivity to either study medication or to related compounds.
Prior participation in studies involving anticonvulsant medications.
Subjects who have received any investigational drug within the previous thirty days.
Subjects with IQ < 70 as determined by the Peabody Picture Vocabulary Test.
Presence of HLA B*1502 in subjects of Asian descent; this will be obtained at screening in subjects of Asian descent.
Intervention: Ibuprofen
Trial phase: Phase 3
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 175
Group description: Participants received a single oral dose of ibuprofen 250 mg caplet, during the 12 hours study.
Eligibility criteria:
Inclusion Criteria:

Outpatients who have undergone surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction.
Subject must have at least moderate pain on the 4-point categorical scale, confirmed by at least 50 mm on the 100 mm VAS PSR scale within approximately 5 hours (i.e., less than or equal to 5 hours, 15 minutes) after surgery is completed.
Female subjects are not pregnant or breast feeding.
Informed consent.

Exclusion Criteria:

Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder determined by the Investigator to place the subject at increased risk, including the presence or history within 2 years of screening.
Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation.
Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP, tramadol, other opioids, or to their combinations.
Intervention: DABIGATRAN ETEXILATE
Trial phase: Phase 3
ATC code: B01AE07
SMILES: CCCCCCOC(=O)NC(=N)c1ccc(NCc2nc3cc(C(=O)N(CCC(=O)OCC)c4ccccn4)ccc3n2C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Participants were orally treated with Dabigatran etexilate 150 milligram (mg) capsule twice daily for 24 weeks.
Eligibility criteria:
Inclusion criteria:

Written informed consent in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and local legislation and/or regulations
Confirmed diagnosis of Cerebral Venous or dural sinus thrombosis (CVT), with or without intracranial haemorrhage
Completion of anticoagulation therapy for 5-15 days which has been administered until randomisation; anticoagulation must include full-dose low molecular weight heparin or unfractionated heparin
Eligibility for treatment with an oral anticoagulant
Further inclusion criteria apply

Exclusion criteria:

Cerebral Venous or dural sinus thrombosis (CVT) associated with central nervous system infection or due to head trauma
Planned surgical treatment for CVT
Conditions associated with increased risk of bleeding
History of symptomatic non-traumatic intracranial haemorrhage with risk of recurrence according to Investigator judgment
Treatment with an antithrombotic regimen for an indication other than CVT and requiring continuation of that treatment for the original diagnosis without change in the regimen
Severe renal impairment
Active liver disease
Pregnancy, nursing or planning to become pregnant while in the trial
Further exclusion criteria apply
Intervention: Warfarin
Trial phase: Phase 3
ATC code: B01AA03
SMILES: CC(=O)CC(c1ccccc1)c1c(O)c2ccccc2oc1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Participants were orally treated with Warfarin 1 mg/3 mg/5 mg tablet, as needed to maintain a target international normalised ratio (INR) of 2.0 - 3.0, once daily for 24 weeks.
Eligibility criteria:
Inclusion criteria:

Written informed consent in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and local legislation and/or regulations
Confirmed diagnosis of Cerebral Venous or dural sinus thrombosis (CVT), with or without intracranial haemorrhage
Completion of anticoagulation therapy for 5-15 days which has been administered until randomisation; anticoagulation must include full-dose low molecular weight heparin or unfractionated heparin
Eligibility for treatment with an oral anticoagulant
Further inclusion criteria apply

Exclusion criteria:

Cerebral Venous or dural sinus thrombosis (CVT) associated with central nervous system infection or due to head trauma
Planned surgical treatment for CVT
Conditions associated with increased risk of bleeding
History of symptomatic non-traumatic intracranial haemorrhage with risk of recurrence according to Investigator judgment
Treatment with an antithrombotic regimen for an indication other than CVT and requiring continuation of that treatment for the original diagnosis without change in the regimen
Severe renal impairment
Active liver disease
Pregnancy, nursing or planning to become pregnant while in the trial
Further exclusion criteria apply
Intervention: Difamilast
Trial phase: Phase 2
SMILES: CCOc1ccccc1C(=O)NCc1coc(-c2ccc(OC(F)F)c(OC(C)C)c2)n1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily.

OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka

Exclusion Criteria:

Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a sudden intensification of atopic dermatitis.
Subjects who have an active viral skin infection.
Subjects with a current or history of malignancy.
Intervention: Difamilast
Trial phase: Phase 2
SMILES: CCOc1ccccc1C(=O)NCc1coc(-c2ccc(OC(F)F)c(OC(C)C)c2)n1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: Subjects were treated with assigned 1% OPA-15406 ointment twice daily.

OPA-15406: Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka

Exclusion Criteria:

Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a sudden intensification of atopic dermatitis.
Subjects who have an active viral skin infection.
Subjects with a current or history of malignancy.
Intervention: Filgotinib
Trial phase: Phase 3
ATC code: L04AA45 | L04AF04
SMILES: O=C(Nc1nc2cccc(-c3ccc(CN4CCS(=O)(=O)CC4)cc3)n2n1)C1CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 118
Group description: Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Eligibility criteria:
Key Inclusion Criteria:

Documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment
Moderately to severely active CD
Cohort A (Biologic Naïve): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids and immunomodulators
Cohort A (Biologic Experienced): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines) or discontinuation of use of at least one of the following agents for reasons other than inadequate clinical response, loss of response or intolerance: tumor necrosis factor alpha (TNFa) antagonists, vedolizumab, and ustekinumab
Cohort B (Biologic Experienced): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): TNFa antagonists, vedolizumab, and ustekinumab

Key Exclusion Criteria:

Current complications of CD such as symptomatic strictures, severe rectal/anal stenosis, fistulae other than perianal fistulae, short bowel syndrome, etc.
Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
Active tuberculosis (TB) or history of latent TB that has not been treated
Use of any prohibited concomitant medications as described in the study protocol

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Intervention: Filgotinib
Trial phase: Phase 3
ATC code: L04AA45 | L04AF04
SMILES: O=C(Nc1nc2cccc(-c3ccc(CN4CCS(=O)(=O)CC4)cc3)n2n1)C1CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 104
Group description: Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
Eligibility criteria:
Key Inclusion Criteria:

Documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment
Moderately to severely active CD
Cohort A (Biologic Naïve): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids and immunomodulators
Cohort A (Biologic Experienced): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines) or discontinuation of use of at least one of the following agents for reasons other than inadequate clinical response, loss of response or intolerance: tumor necrosis factor alpha (TNFa) antagonists, vedolizumab, and ustekinumab
Cohort B (Biologic Experienced): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): TNFa antagonists, vedolizumab, and ustekinumab

Key Exclusion Criteria:

Current complications of CD such as symptomatic strictures, severe rectal/anal stenosis, fistulae other than perianal fistulae, short bowel syndrome, etc.
Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
Active tuberculosis (TB) or history of latent TB that has not been treated
Use of any prohibited concomitant medications as described in the study protocol

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Intervention: SODIUM BICARBONATE
Trial phase: Not Applicable
ATC code: B05CB04 | B05XA02
SMILES: O=C([O-])O.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: Participants assigned to oral sodium bicarbonate will receive 0.5 mEq/kg-lean body weight (LBW)/day for the entire 12 months. Participants will take ½ the daily dose in the morning and the other ½ in the evening. The number of capsules will be rounded to the nearest whole capsule. To reduce pill burden and increase compliance the maximum number of pills per day will be six.

Sodium bicarbonate
Eligibility criteria:
Inclusion Criteria:

Age ≥ 21 years
Serum bicarbonate 22-25 mEq/L on 2 separate measurements (at least 1 day apart)
CKD stage 3B or 4 at time of screening (eGFR 15-44 ml/min/1.73m2)
Blood pressure <130/80 mm Hg prior to randomization
BMI < 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients).
Able to provide consent
Stable anti-hypertensive regimen for at least one month prior to randomization
Not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin).

Exclusion Criteria:

Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
Uncontrolled hypertension
Serum potassium < 3.3 or ≥ 5.5 mEq/L at screening
New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months
Factors judged to limit adherence to interventions
Anticipated initiation of dialysis or kidney transplantation within 12 months
Current participation in another research study
Pregnancy or planning to become pregnant or currently breastfeeding
Chronic use of supplemental oxygen
Use of immunosuppression in past 3 months
Metal implant or implanted electrical device (patient will be unable to get MRI)
Intervention: Sevoflurane
Trial phase: Not Applicable
ATC code: N01AB08
SMILES: FCOC(C(F)(F)F)C(F)(F)F
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 28
Group description: The patients will maintained general anesthesia with sevoflurane.

Sevoflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.

General anesthesia will maintained with sevoflurane 2-3 vol%.
Eligibility criteria:
Inclusion Criteria:

American society of anesthesiologist class 1 patients
3-6 years children undergoing entropion surgery

Exclusion Criteria:

Do not agree with participate this study
Intervention: Desflurane
Trial phase: Not Applicable
ATC code: N01AB07
SMILES: FC(F)OC(F)C(F)(F)F
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 28
Group description: The patients will maintained general anesthesia with desflurane.

Desflurane: Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.

General anesthesia will maintained with desflurane 6-7vol%.
Eligibility criteria:
Inclusion Criteria:

American society of anesthesiologist class 1 patients
3-6 years children undergoing entropion surgery

Exclusion Criteria:

Do not agree with participate this study
Intervention: Mycapssa
Trial phase: Phase 2
ATC code: H01CB02
SMILES: CC(O)C(CO)NC(=O)C1CSSCC(NC(=O)C(N)Cc2ccccc2)C(=O)NC(Cc2ccccc2)C(=O)NC(Cc2c[nH]c3ccccc23)C(=O)NC(CCCCN)C(=O)NC(C(C)O)C(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: This group will continue to receive treatments that have already been initiated to manage bronchial secretions. Additionally, this group will receive parenteral octreotide.
Eligibility criteria:
Inclusion Criteria:

Patients are being weaned from mechanical ventilation
Excessive bronchial secretions (over 200 ml/24 hours) is deemed by the Primary Team to be a major barrier to extubation

Exclusion Criteria:

Known hypersensitivity to octreotide
Persistent bradycardia (HR < 60)
Mobitz type II or 3rd degree heart block in patients without a pacemaker
Patients being treated with intravenous agents for hypertensive urgency or emergency
Surgical patients
Initiation of therapy with systemic or inhaled steroids within 72 hours prior to the enrollment into the study, as these may further change the rate of secretions*
Initiation of therapy with systemic or inhaled anticholinergics within 48 hours prior to the enrollment into the study, as these may further change the rate of secretions
Intervention: Mirabegron
Trial phase: Phase 1 | Phase 2
ATC code: G04BD12
SMILES: Nc1nc(CC(=O)Nc2ccc(CCNC[C@H](O)c3ccccc3)cc2)cs1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Single-center, non-randomized, single-arm study Participants received Mirabegron 25 mg for 2 weeks and switched to the 50 mg for 10 weeks.
Eligibility criteria:
Inclusion Criteria:

presence of mild ED [Erectile Function domain of the International Index of Erectile Function (IIEF EF) score 22-25], mild to moderate ED (IIEF EF domain score 17-21) or moderate ED (IIEF EF domain score 11-16)
presence of OAB symptoms for at least 3 months
at least 3 micturitions per day
at least 3 episodes of urgency in a 3 day period

Exclusion Criteria:

history of pelvic surgery
concurrent ED therapy
history of penile surgery
history of priapism (unwanted, prolonged painful erection)
history of neurologic disease
uncontrolled hypertension: systolic blood pressure (BP) > 140 mmHg or diastolic BP > 90 mmHg
Stage 4 or 5 chronic kidney disease, Creatinine clearance rate < 30ml/min
moderate or severe hepatic impairment
concomitant use of CYP2D6-metabolized drugs or digoxin
post void residual greater than 150 ml
evidence of urinary tract infection on urinalysis and/or urine culture
Intervention: Teneligliptin
Trial phase: Phase 3
ATC code: A10BH08
SMILES: [H][C@@]1(N2CCN(c3cc(C)nn3-c3ccccc3)CC2)CN[C@]([H])(C(=O)N2CCSC2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 127
Group description: Teneligliptin (20mg once daily) for 24 weeks
Eligibility criteria:
Inclusion Criteria:

A signed and dated informed consent form has been obtained from the subject, in accordance with International Conference on Harmonisation guidelines on Good Clinical Practice (ICH GCP), before any screening or study related procedures take place.
The subject is aged ≥18 years at signature of the informed consent form.
Hospitalization status: outpatient.
The subject has had a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (Day -28).
The subject is undergoing diet and exercise therapy, and diet and exercise regimen has not been changed for at least 8 consecutive weeks at the screening visit (Day -28). Subjects who cannot do exercise due to complication are not limited to this criteria.
The subject's glycosylated fraction of haemoglobin(HbA1c) is ≥ 7.0% and < 10.0% at the screening visit (Day -28) and on Day -14.

Exclusion Criteria:

The subject has a history of type 1 diabetes mellitus or a secondary form of diabetes.
The subject has received insulin within 1 year prior to the screening visit (Day -28), with the exception of insulin therapy during hospitalization or insulin therapy for medical conditions not requiring hospitalization (< 2 weeks' duration).
The subject has received an anti-diabetic drug within 8 weeks prior to the screening visit (Day -28).