anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cannabidiol
Trial phase: Phase 2
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 9
Group description: The dose of Cannabidiol Oral Solution will begin at 20 mg/kg/day [10 mg/kg twice per day (BID)], will be adjusted at any time if the investigator feels the safety or well-being of the participant is at risk, and will be titrated up or down according to protocol-stipulated parameters and at the investigator's discretion after Day 14 to enhance efficacy. Dose will not exceed 40 mg/kg/day.
Eligibility criteria:
Inclusion Criteria:

Meets protocol-specified criteria for qualification, including infantile spasms
Parent(s)/caregiver(s) fully comprehend and sign the informed consent form, understand all study procedures, and can communicate satisfactorily with the Investigator and study coordinator.

Exclusion Criteria:

History or current use of over-the-counter medications, dietary supplements, or drugs outside protocol-specified parameters

Signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

the safety or well-being of the participant or study staff
the analysis of results

During the Safety Treatment and Follow-up Periods, subjects are not to receive the following:

any cannabinoids (CBD, Δ9-tetrahydrocannabinol (THC), hemp oil, Realm Oil or marijuana)
any other investigational drug or investigational device
Intervention: Pantoprazole
Trial phase: Not Applicable
ATC code: A02BC02 | A02BD04 | A02BD11
SMILES: COc1ccnc(CS(=O)c2nc3ccc(OC(F)F)cc3[nH]2)c1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Pantoprazole Tab 40mg qd for 6 monthrs.

proton pump inhibitor group: pantoprazole tab 40 mg qd for 6 months.
Eligibility criteria:
Inclusion Criteria:

Recent endoscopic examination (within 2 months) reveals normal appearance or erythematous patches only (without subepithelial hemorrhages, erosions or ulcers).
Peptic ulcers (a mucosal break ³ 5 mm in diameter) have been documented by a previous endoscopic examination.
Subjects have received thienopyridine therapy for at least two weeks.
Requiring long-term anti-platelet therapy for ischemic cardiovascular diseases.

Exclusion Criteria:

A history of gastric or duodenal surgery other than oversewing of a perforation.
Subjects who are allergic to the study drugs.
Requiring long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, aspirin, or anticoagulant agents.
Pregnancy.
Subjects who have active cancer, acute serious medical illness or terminal illness.
Subjects who have gastroesophageal reflux disease.
Intervention: Famotidine
Trial phase: Not Applicable
ATC code: A02BA03 | A02BA53
SMILES: NC(N)=Nc1nc(CSCCC(N)=NS(N)(=O)=O)cs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: famotidine Tab 40 mg qd for 6 months.

histamine-2 receptor antagonist group: famotidine tab 40 mg qd for 6 months.
Eligibility criteria:
Inclusion Criteria:

Recent endoscopic examination (within 2 months) reveals normal appearance or erythematous patches only (without subepithelial hemorrhages, erosions or ulcers).
Peptic ulcers (a mucosal break ³ 5 mm in diameter) have been documented by a previous endoscopic examination.
Subjects have received thienopyridine therapy for at least two weeks.
Requiring long-term anti-platelet therapy for ischemic cardiovascular diseases.

Exclusion Criteria:

A history of gastric or duodenal surgery other than oversewing of a perforation.
Subjects who are allergic to the study drugs.
Requiring long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, aspirin, or anticoagulant agents.
Pregnancy.
Subjects who have active cancer, acute serious medical illness or terminal illness.
Subjects who have gastroesophageal reflux disease.
Intervention: Nicotine
Trial phase: Phase 1
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Subject receiving transdermal nicotine in either the first or last week of the study and completing all study visits.
Eligibility criteria:
Inclusion criteria:

Age: 18-60
Gender: All
Language: Communicative in English
Participants with a prior diagnosis of DSM-5 ASD at some point in their lifetime OR a DSM-4 diagnosis of Autism OR a DSM-4 diagnosis of Asperger's syndrome OR a DSM-4 diagnosis of Pervasive Developmental Disorder Not Otherwise Specified.
Symptoms of irritability, agitation or aggression as reported by parent and/or participant
Aberrant behavior checklist - Irritability Subscale (ABC-I) score of 16 or higher
No changes in psychotropic medications within the past 14 days.
Either lives with a primary caregiver or closely engaged with a primary caregiver who interacts with the patient daily
BMI > 17.5 and < 45

Exclusion criteria:

Age < 18 or > 60
BMI < 17.5 or > 45
Currently using tobacco or any nicotine products (transdermal, gum, e-cigarettes)
Changes in psychotropic medication management within the past 14 days
Previous allergy to transdermal patches
Patients with heart rate > 100 or < 50 or known history of cardiac rhythm abnormalities
Systolic blood pressure > 150 or < 95; diastolic blood pressure > 90 or < 50
No symptoms of irritability, agitation, or aggression as reported by parent and/or participant
ABC-I score of less than 16
No primary caregiver, or primary caregiver unable to assist with rating scales
Intervention: Modafinil
Trial phase: Not Applicable
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Medication (armodafinil) only, without CBTI.

Armodafinil: Active medication
Eligibility criteria:
Inclusion Criteria:

eligible subjects must have begun their CPAP treatment within the last 3 months
current ESS (Sleepiness) Scores between 5-19
no history of upper airway surgery (e.g. UPPP)
able to understand written and spoken English
able to swallow medication
preferred sleep phase between 9:00 pm and 9:00 am
willing to discontinue any sleep medications/over-the-counters(OTCs)/Herbals for insomnia for the 11-week study period.
female participants must not be pregnant or breastfeeding and must agree to use two forms of birth control during the study period, as Armodafinil may interfere with hormonal birth control.
all participants will be asked to postpone any additional or alternate treatments for their Obstructive Sleep Apnea (OSA) until after the completion of their participation in this research study.
for other elective procedures, prospective participants are recommended to either postpone the procedure until after completion of their participation in this study, or alternatively to start the study after completion of the elective procedure.

Exclusion Criteria:

CPAP usage exceeding three months prior to pre-screening
suicide attempts within the last five years
unstable medical or psychiatric illness
cardiac abnormalities, liver, or kidney diseases
sleep disorders other than insomnia or SDB
evidence of active illicit substance use or fitting criteria for alcohol abuse or dependence
use of central nervous system (CNS) active medications, antidepressants and hypnotics prescribed as sleep-aids (these medications are permitted if prescribed for mediation of symptoms other than sleep and the patient has been on a stable dosage for a minimum of one month, with no anticipation of altering their dosage during the study period.)
inadequate language comprehension
pregnant or breastfeeding
Intervention: Doxycycline
Trial phase: Phase 3
ATC code: A01AB22 | J01AA02 | J01AA20
SMILES: [H][C@@]12C(=C(O)[C@]3(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]3([H])[C@H]1O)C(=O)c1c(O)cccc1[C@@H]2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 121
Group description: Doxycycline 200 mg once daily for six weeks

Doxycycline
Eligibility criteria:
Inclusion Criteria:

Neurological symptoms suggestive of LNB without other obvious reasons and one or both of

Cerebrospinal fluid pleocytosis ≥5 leukocytes pr mm3
Intrathecal Bb antibody production
Signed informed consent

Exclusion Criteria:

Age less than 18 years
Pregnancy, breast-feeding
Adverse reaction to tetracyclines
Treatment with cephalosporin, penicillin, or tetracycline the last 14 days
Serious liver or kidney disease that contraindicates use of doxycycline
Lactose intolerance
Need to use medications contraindicated according to Summary of Product Characteristics of the Investigational Medicinal Product
Intervention: Memantine
Trial phase: Phase 4
ATC code: N06DA52 | N06DA53 | N06DX01
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Memantine 20 mg once daily, tablets, orally AND Placebo tablets once daily, orally
Eligibility criteria:
Inclusion Criteria:

The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinical visits during the study.
The patient has a diagnosis of probable AD consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
The patient has a Mini Mental State Examination (MMSE) score ≥ 5 and ≤ 18 at Screening visit
The dose of Memantine has been stable at 20 mg once a day for at least 3 month prior to screening

Exclusion Criteria:

The patient has one or more of the following conditions: Evidence and/or history of any clinically significant neurodegenerative disease or other serious neurological disorders other than Alzheimer's disease including, but not limited to, Lewy body dementia, Fronto-Temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, Multiple Sclerosis, major head trauma and primary or secondary cerebral neoplasm.
The patient has a modified Hachinski ischemia score greater than 4 at the screening visit.
The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than AD
The patient is currently receiving treatment with an unstable dose of acetyl cholinesterase inhibitor

Other protocol defined inclusion and exclusion criteria may apply
Intervention: Memantine
Trial phase: Phase 4
ATC code: N06DA52 | N06DA53 | N06DX01
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Memantine 10 mg twice daily, tablets, orally AND Placebo tablets twice daily, orally
Eligibility criteria:
Inclusion Criteria:

The patient has a knowledgeable and reliable caregiver who will accompany the patient to all clinical visits during the study.
The patient has a diagnosis of probable AD consistent with the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
The patient has a Mini Mental State Examination (MMSE) score ≥ 5 and ≤ 18 at Screening visit
The dose of Memantine has been stable at 20 mg once a day for at least 3 month prior to screening

Exclusion Criteria:

The patient has one or more of the following conditions: Evidence and/or history of any clinically significant neurodegenerative disease or other serious neurological disorders other than Alzheimer's disease including, but not limited to, Lewy body dementia, Fronto-Temporal dementia, Parkinson's disease, Huntington's disease, major cortical stroke, Multiple Sclerosis, major head trauma and primary or secondary cerebral neoplasm.
The patient has a modified Hachinski ischemia score greater than 4 at the screening visit.
The patient has any current psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than AD
The patient is currently receiving treatment with an unstable dose of acetyl cholinesterase inhibitor

Other protocol defined inclusion and exclusion criteria may apply
Intervention: Ketamine
Trial phase: Phase 2
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Ketamine induction

Ketamine: Ketamine used for induction
Eligibility criteria:
Scheduled to undergo cardiac surgery.

Inclusion criteria:

age greater than or equal to 75 years presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota;
schedule to undergo complex cardiac surgery. Complex cardiac surgery will be defined as surgery involving more than one heart valve, redo-sternotomy procedures, or combined valvular and CABG procedures.

Exclusion criteria will include:

left or right ventricular assist device implantation or explantation,
procedures not requiring cardiopulmonary bypass,
active infection or sepsis, severe hepatic disease or ascites,
pre-operative renal dysfunction including a baseline creatinine equal to or greater than 1.5 mg/dL or requiring dialysis,
immunosuppressive medication use (including steroid use),
immunodeficiency syndrome,
known neurologic or psychiatric disorder, or
use of drugs for psychosis.
Intervention: Propofol
Trial phase: Phase 2
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Propofol induction

Propofol: Propofol used for induction
Eligibility criteria:
Scheduled to undergo cardiac surgery.

Inclusion criteria:

age greater than or equal to 75 years presenting for cardiac surgery at the Mayo Clinic in Rochester, Minnesota;
schedule to undergo complex cardiac surgery. Complex cardiac surgery will be defined as surgery involving more than one heart valve, redo-sternotomy procedures, or combined valvular and CABG procedures.

Exclusion criteria will include:

left or right ventricular assist device implantation or explantation,
procedures not requiring cardiopulmonary bypass,
active infection or sepsis, severe hepatic disease or ascites,
pre-operative renal dysfunction including a baseline creatinine equal to or greater than 1.5 mg/dL or requiring dialysis,
immunosuppressive medication use (including steroid use),
immunodeficiency syndrome,
known neurologic or psychiatric disorder, or
use of drugs for psychosis.
Intervention: Human Menopausal Gonadotrophin
Trial phase: Phase 4
ATC code: G03GA02
SMILES: CC(C)(C)CCCCC=O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 310
Group description: Menotropins for injection, provided as a vial with powder (75 IU FSH activity and 75 IU LH activity) and a vial with diluent.
Eligibility criteria:
Inclusion Criteria:

Females aged 21 to 35 years with regular ovulatory menstrual cycles of 21 to 45 days, with a Body Mass Index (BMI) between 18 and 30 kg/m2 who desire pregnancy.
Subjects must be high responders, defined as subjects who have a serum anti-Müllerian hormone (AMH) ≥5 ng/mL at screening.
Documented history of infertility (e.g., unable to conceive for at least 12 months or for at least 6 months if receiving donor sperm) with a Day 2 or Day 3 serum FSH level between 1 and 12 IU/L (inclusive), the results of which should be obtained within 6 months prior to randomization.

Exclusion Criteria:

Known stage III-IV endometriosis (American Society for Reproductive Medicine, 2012).
History of recurrent miscarriage not followed by a live birth (recurrent is defined as two (2) or more consecutive miscarriages).
Previous in vitro fertilization (IVF) or assisted reproductive technology (ART) failure due to a poor response to gonadotropins. Poor response is defined as development of ≤2 mature follicles or history of 2 previous failed cycle cancellations prior to oocytes retrieval due to poor response.
Intervention: Augmentin
Trial phase: Phase 3
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
Healthy volunteers: No
Participants at risk: 254
Group description: Amoxicillin-clavulanate (90/6.4 mg/kg/d in 2 divided dosed for 10 days)
Eligibility criteria:
Inclusion Criteria:

Meets criteria for "persistent" or "worsening" presentations of sinusitis
Baseline score ≥9 on the Pediatric Rhinosinusitis Symptom Scale

Exclusion Criteria:

Severe presentation (≥3 days of colored nasal discharge and fever ≥39°C
Asthma/allergic rhinitis explains symptoms
Allergy to amoxicillin-clavulanate
Immotile cilia syndrome
Cystic fibrosis
Immunodeficiency
Parental inability to read/write English or Spanish
Other concurrent infection (e.g., pneumonia, acute otitis media, streptococcal pharyngitis)
Systemic toxicity
Wheezing on exam
Antibiotic use within 15 days
Intervention: Cyclosporine
Trial phase: Phase 4
ATC code: L04AD01 | S01XA18
SMILES: CC=CCC(C)C(O)C1C(=O)NC(CC)C(=O)N(C)CC(=O)N(C)C(CC(C)C)C(=O)NC(C(C)C)C(=O)N(C)C(CC(C)C)C(=O)NC(C)C(=O)NC(C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(C(C)C)C(=O)N1C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 50
Group description: 1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
Eligibility criteria:
Inclusion:

Has Eye Symptoms when using video display terminals
Has a reported history of dry eye in both eyes.

Exclusion:

Diagnosed with eye infection or active inflammation.
Has worn contact lenses within the past 7 days or anticipated use during the study.
Has used any eye drops within 2 hours.
Has had laser-assisted in situ keratomileusis (LASIK) within 12 months.
Has used Restasis® within 90 days.
Has had any eye and or/lid surgeries within 6 months.
Has had cataract surgery in either eye.
Has current punctal occlusion or anticipate a change in punctal occlusion status at any point during the study.
Is currently taking any topical ophthalmic prescriptions or over-the-counter solutions, artificial tears, gels or lid scrubs that cannot be discontinued for the trial duration.
Use of medication known to cause ocular drying that is not on a stable dose for at least 30 days.
Intervention: Simethicone
Trial phase: Phase 2 | Phase 3
SMILES: CO[Si](C)(C)O[Si](C)(C)C.O=[Si]=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Liquid simethicone (1ml volume) in 5mls of water

Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.

27 patients randomized to this group.
Eligibility criteria:
Inclusion Criteria:

Planned for an elective diagnostic gastroscopy by the attending gastroenterologist
Age of at least 21 years old
Mentally competent and able to provide informed consent

Exclusion Criteria:

Category A patients (incarcerated prisoners)
adults who are unable to give their own informed consent due to lack of mental capacity
suspected gastrointestinal bleeding
suspected impacted foreign material
suspected gastric outlet obstruction
suspected esophageal obstruction
history of dysphagia
known hypersensitivity to simethicone
previous gastrectomy
Intervention: Fevipiprant
Trial phase: Phase 3
SMILES: Cc1c(CC(=O)O)c2cccnc2n1Cc1ccc(S(C)(=O)=O)cc1C(F)(F)F
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 299
Group description: QAW039 150 mg
Eligibility criteria:
Inclusion Criteria:

Written informed consent and assent (if applicable).
Male and female patients aged ≥12 years (or ≥lower age limit allowed by health authority and/or ethics committee/institutional review board approvals).
A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.
Evidence of airway reversibility or airway hyper- reactivity.
FEV1 of ≤80% of the predicted normal value for patients aged ≥18 years; FEV1 of ≤90% for patients aged 12 to <18 years
An ACQ score ≥1.5.
A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.

Exclusion Criteria:

Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
Subjects who have participated in another trial of QAW039.
A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).
History of malignancy with the exception of local basal cell carcinoma of the skin.
Pregnant or nursing (lactating) women.
Serious co-morbidities.
Patients on greater than 20 mg of simvastatin, greater than 40 mg of atorvastatin, greater than 40 mg of pravastatin, or greater than 2 mg of pitavastatin
Intervention: Fevipiprant
Trial phase: Phase 3
SMILES: Cc1c(CC(=O)O)c2cccnc2n1Cc1ccc(S(C)(=O)=O)cc1C(F)(F)F
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 293
Group description: QAW039 450 mg
Eligibility criteria:
Inclusion Criteria:

Written informed consent and assent (if applicable).
Male and female patients aged ≥12 years (or ≥lower age limit allowed by health authority and/or ethics committee/institutional review board approvals).
A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.
Evidence of airway reversibility or airway hyper- reactivity.
FEV1 of ≤80% of the predicted normal value for patients aged ≥18 years; FEV1 of ≤90% for patients aged 12 to <18 years
An ACQ score ≥1.5.
A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.

Exclusion Criteria:

Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
Subjects who have participated in another trial of QAW039.
A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).
History of malignancy with the exception of local basal cell carcinoma of the skin.
Pregnant or nursing (lactating) women.
Serious co-morbidities.
Patients on greater than 20 mg of simvastatin, greater than 40 mg of atorvastatin, greater than 40 mg of pravastatin, or greater than 2 mg of pitavastatin
Intervention: Rivaroxaban
Trial phase: Phase 3
ATC code: B01AF01
SMILES: O=C(NC[C@H]1CN(c2ccc(N3CCOCC3=O)cc2)C(=O)O1)c1ccc(Cl)s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 405
Group description: Participants received rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Eligibility criteria:
Inclusion Criteria:

Have histologically confirmed solid malignancy including but not limited to: pancreas, lung, stomach, colon, rectum, bladder, breast, ovary, renal or lymphoma (hematologic), with locally advanced or metastatic disease
Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
Have a Khorana thromboembolic risk Score greater than or equal to (>=) 2
Creatinine clearance (CrCl) >= 30 milliliter per minute (mL/min)
Plan to initiate systemic cancer therapy within plus or minus (+-) 1 week of receiving the first dose of study drug with the intention of receiving systemic cancer therapy during the double-blind treatment period for an intended duration determined by the treating oncologist according to standard protocols of clinical care

Exclusion Criteria:

Diagnosis of primary brain tumors
Known history of brain metastases
Bleeding diathesis, hemorrhagic lesions, active bleeding, and other conditions with a high risk for bleeding
Hematologic malignancies with the exception of lymphoma
Platelet count less than (<) 50,000/millimeter^3 (mm^3), Life expectancy of less than or equal to (<=) 6 months