anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Victoza
Trial phase: Phase 3
ATC code: A10BJ02
SMILES: CCCCCCCCCCCCCCCC(=O)NC(CCC(=O)NCCCCC(NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(N)=O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1ccccc1)C(=O)NC(C(=O)NC(C)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)O)C(C)C)C(C)CC)C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 125
Group description: Participants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.
Eligibility criteria:
Inclusion Criteria:

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Male or female, age 12 to less than 18 years at the time of signing informed consent and less than 18 years at date of randomisation
BMI corresponding to equal to or above 30 kg/m^2 for adults by international cut-off points and equal or above the 95th percentile for age and sex (for diagnosis of obesity)
Stable body weight during the previous 90 days before screening V2 (below 5 kg self-reported weight change)
History of failing to lose sufficient weight with lifestyle modification as judged by the investigator and documented in subject's medical record

Exclusion Criteria:

Pre-pubertal subjects (Tanner stage 1) at screening V2
Type 1 diabetes mellitus (T1DM)
Family or personal history of multiple endocrine neoplasia type 2 (MEN2)
Medullary thyroid carcinoma (MTC)
History of pancreatitis (acute or chronic)
Subjects with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes)
Treatment with medications within 90 days before screening V2 that, based on the investigator's judgement, may cause significant weight change. This should also include treatment with any of the following medications: pramlintide, orlistat, zonisamide, topiramate, lorcaserin, phenteremine, bupropion, naltrexone, glucagon-like peptide-1 (GLP-1) receptor agonists, or metformin (used as treatment for obesity)
Anti-diabetic treatment other than metformin
History of major depressive disorder within 2 years before screening V2
Intervention: Gallium Ga-68 gozetotide
Trial phase: Phase 2 | Phase 3
ATC code: V09IX14
SMILES: O=C([O-])CCc1ccc(O)c(CN(CCN(CC(=O)[O-])Cc2cc(CCC(=O)NCCCCCC(=O)NCCCC[C@H](NC(=O)N[C@@H](CCC(=O)O)C(=O)O)C(=O)O)ccc2O)CC(=O)[O-])c1.[68Ga+3]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 385
Group description: PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.

Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
Eligibility criteria:
Inclusion Criteria:

Histopathological proven prostate adenocarcinoma.

Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation

PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and,
Confirmatory persistent PSA greater than 0.2 ng/mL

Post-radiation therapy -ASTRO-Phoenix consensus definition

Nadir + greater than or equal to 2 ng/mL rise in PSA
Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).
Age > 18.
Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

Investigational therapy for prostate cancer.
Unable to lie flat, still or tolerate a PET scan.
Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).
Intervention: Nicotine
Trial phase: Phase 4
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants will receive 3 weeks of active NRT patches

Nicoderm Patch: Nicotine replacement therapy patch
Eligibility criteria:
Inclusion Criteria:

Patient is currently smoking >5 cigarettes/day for the past 30 days; there is no evidence that NRT is useful in those who smoke <5cpd.
Patient is able to participate and willing to provide informed consent; participants will need to follow directions and adhere to the medication usage instructions as outlined in the informed consent document.
Patients is willing to be contacted by phone for follow up at 1 month and 6 months post-discharge; these time points will assess our final outcome of cessation at 6 months post-discharge.

Exclusion Criteria:

Patient is scheduled for surgery in < 7 days; most patients need to be using NRT consistently for 2 weeks for it to be fully effective.
Patient is currently using a smoking cessation product (i.e. nicotine containing patch, gum, inhaler, lozenge, spray or nicotine containing electronic cigarette, varenicline, buproprion) or has used a smoking cessation aid consistently for more than 72 consecutive hours with the intent to reduce cigarette consumption or quit smoking within 30 days of the baseline Pre-admission Unit (PAU) visit; this will ensure the effects of the study patches will be assessed without any contamination from other cessation products.
Patient is willing to refrain from using any other cessation products (nicotine containing patch, gum, inhaler, lozenge, spray, nicotine containing electronic cigarette, varenicline, buproprion) prior to surgery; this will allow us to track the usage and side effects with the study patches.
Patient is allergic to the adhesive on the nicotine replacement therapy patch.
Patient is unable to read and understand English or French; study materials will only be supplied in these two languages.
Intervention: Sevoflurane
Trial phase: Phase 1 | Phase 2
ATC code: N01AB08
SMILES: FCOC(C(F)(F)F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Patients in the inhaled anesthesia arm will be given sevoflurane anesthesia maintenance for the duration of the procedure including cardiopulmonary bypass.

Sevoflurane: Volatile Anesthetic
Eligibility criteria:
Inclusion Criteria:

Adult patients (age 18+)
Undergoing cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

Emergency surgery
History of severe COPD, emphysema, or ILD
Recent (<2wk) or current use of systemic glucocorticoids
Prior history of pneumothorax
Allergy/contraindication to intravenous anesthetics
Personal or family history of malignant hyperthermia or high risk for malignant hyperthermia
Intervention: Propofol
Trial phase: Phase 1 | Phase 2
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Patients in the intravenous anesthesia arm will be given total intravenous anesthesia with propofol for the duration of the procedure including cardiopulmonary bypass.

Propofol: Intravenous Anesthetic
Eligibility criteria:
Inclusion Criteria:

Adult patients (age 18+)
Undergoing cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

Emergency surgery
History of severe COPD, emphysema, or ILD
Recent (<2wk) or current use of systemic glucocorticoids
Prior history of pneumothorax
Allergy/contraindication to intravenous anesthetics
Personal or family history of malignant hyperthermia or high risk for malignant hyperthermia
Intervention: Gallium Ga-68 gozetotide
Trial phase: Phase 2 | Phase 3
ATC code: V09IX14
SMILES: O=C([O-])CCc1ccc(O)c(CN(CCN(CC(=O)[O-])Cc2cc(CCC(=O)NCCCCCC(=O)NCCCC[C@H](NC(=O)N[C@@H](CCC(=O)O)C(=O)O)C(=O)O)ccc2O)CC(=O)[O-])c1.[68Ga+3]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 299
Group description: PSMA PET imaging: Patients will receive Ga-68 labeled PSMA-11 PET and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.

Ga-68 labeled PSMA-11 PET: Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
Eligibility criteria:
Inclusion Criteria:

Biopsy proven prostate adenocarcinoma.
Planned prostatectomy with lymph node dissection.
Intermediate to high-risk disease (as determined by elevated Prostate-specific antigen (PSA) [PSA>10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors).
Diagnostic CT or MRI as part of the PET study or performed within one month of PSMA PET.
Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).
Age > 18.
Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy.
Including focal ablation techniques (HiFu).
Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging and surgery.
Intervention: Acthargel
Trial phase: Phase 4
SMILES: CSCCC(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(N)CO)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1cnc[nH]1)C(=O)NC(Cc1ccccc1)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NCC(=O)NC(CCCCN)C(=O)N1CCCC1C(=O)NC(C(=O)NCC(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)N1CCCC1C(=O)NC(C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(Cc1ccc(O)cc1)C(=O)N1CCCC1C(=O)NC(CC(N)=O)C(=O)NCC(=O)NC(C)C(=O)NC(CCC(=O)O)C(=O)NC(CC(=O)O)C(=O)NC(CCC(=O)O)C(=O)NC(CO)C(=O)NC(C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(Cc1ccccc1)C(=O)N1CCCC1C(=O)NC(CC(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1ccccc1)C(=O)O)C(C)C)C(C)C)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 77
Group description: Participants who received Acthar Gel in Part 2 with AEs during Part 2
Eligibility criteria:
Inclusion Criteria:

Male or nonpregnant, nonlactating female subjects
Meets criteria for definite rheumatoid arthritis as defined by 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification at screening
Has active disease defined as a score of >3.2 on DAS28-ESR prior to study drug administration despite dual-DMARD treatment
Is on a stable dose of ≤ 20 mg per week of methotrexate for at least 8 weeks AND a stable dose of an allowed DMARD for at least 24 weeks prior to the screening visit
May also be on a stable dose of 10 mg or less of prednisone or other the dose equivalent of another corticosteroid for 4 weeks prior to study drug administration

Exclusion Criteria:

Has current rheumatoid disease or inflammatory joint disease other than RA
Has any history of use of adrenocorticotropic hormone (ACTH) for the treatment of RA
Has taken B-cell mediated therapies in the 6 months prior to screening
Has hepatitis B, hepatitis C, history of tuberculosis (TB) or other contraindication as per the United States (US) Prescribing Information for Acthar
Has history of Type 1 or Type 2 diabetes
Has any clinically significant infection
Intervention: Ethanol
Trial phase: Phase 4
ATC code: D08AX08 | V03AB16 | V03AZ01
SMILES: CCO
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 4
Group description: platelet-rich plasma injection into the head-neck junction of the hip joint
Eligibility criteria:
Inclusion Criteria:

Patients with symptomatic FAI
Clinical and radiographic evidence of FAI
Patients able to provide consent to study participation
Completion of 6 weeks of physical therapy program

Exclusion Criteria:

Established Osteoarthritis (Kellgren-Lawrence > 3)
Minimum joint space > 2 mm as measured on AP radiograph
Hip dysplasia (center edge angle < 20° on AP radiograph)
Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer or diabetes
Patients with ongoing infection including HIV and Hepatitis
Patient with history of osteomyelitis/septic arthritis
Anticoagulation therapy
Patients who are pregnant or breast feeding
Patients with systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, and synovial chondromatosis
Patients taking immunosuppressant medication
Patients with abnormal hematology or serum chemistry lab results
Patients receiving injection to treatment knee within 2 months of study enrollment
BMI greater than 35 or less than 20
Intervention: Rifaximin
Trial phase: Phase 3
ATC code: A07AA11 | D06AX11
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Patients received Rifaximin 200 mg tablet 3 times per day for 3 days.
Eligibility criteria:
Inclusion Criteria:

Patient is able to read and understood the language of the Informed Consent Form and Patient Information.
International travelers with a duration of stay in host country long enough to attend schedules visits.
Affected by naturally acquired acute diarrhea, defined as the passage of at least 3 unformed stools within 24 hours immediately preceding randomization preceding randomization

Exclusion Criteria:

Hypersensitivity to rifaximin or any of the rifamycin antimicrobial agents or to any of the excipients of the study drug.
Pregnant, breast feeding or planning pregnancy
Acute diarrhea for > 72 hours immediately prior to randomization.
Presence of fever (≥ 100 °F/37.8°C) or hematochezia (blood in stool, noted visually) or clinical findings suggesting moderate or severe dehydration.
Intervention: Rifaximin
Trial phase: Phase 3
ATC code: A07AA11 | D06AX11
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Patients received Xifaxan 200 mg tablet 3 times per day for 3 days.
Eligibility criteria:
Inclusion Criteria:

Patient is able to read and understood the language of the Informed Consent Form and Patient Information.
International travelers with a duration of stay in host country long enough to attend schedules visits.
Affected by naturally acquired acute diarrhea, defined as the passage of at least 3 unformed stools within 24 hours immediately preceding randomization preceding randomization

Exclusion Criteria:

Hypersensitivity to rifaximin or any of the rifamycin antimicrobial agents or to any of the excipients of the study drug.
Pregnant, breast feeding or planning pregnancy
Acute diarrhea for > 72 hours immediately prior to randomization.
Presence of fever (≥ 100 °F/37.8°C) or hematochezia (blood in stool, noted visually) or clinical findings suggesting moderate or severe dehydration.
Intervention: Ketamine
Trial phase: Phase 3
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 35
Group description: 0.25 mg/kg of sub-dissociative ketamine as an experimental arm

Ketamine: sub-dissociative ketamine
Eligibility criteria:
Inclusion Criteria:

All adult subjects over the age of 18 with chronic pain* presenting to the emergency department with exacerbation of their chronic pain as their primary complaint
Subjects who are willing and able to provide informed consent. *Chronic pain defined as greater > 3 months of symptoms and an initial VAS pain score > 70

Exclusion Criteria:

History of overt psychosis, severe hypertension as defined by Systolic Blood Pressure > 180 mm Hg or Diastolic Blood Pressure >110 mm Hg, unstable angina, Coronary Artery Disease, Congestive Heart Failure, porphyrias, thyroid disease, seizure disorder, inability to provide informed consent: dementia, non-English/Spanish speakers, subjects in custody, suicidal, or clinically intoxicated.
Intervention: Ketamine
Trial phase: Phase 3
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: 0.50 mg/kg of sub-dissociative ketamine as an experimental arm

Ketamine: sub-dissociative ketamine
Eligibility criteria:
Inclusion Criteria:

All adult subjects over the age of 18 with chronic pain* presenting to the emergency department with exacerbation of their chronic pain as their primary complaint
Subjects who are willing and able to provide informed consent. *Chronic pain defined as greater > 3 months of symptoms and an initial VAS pain score > 70

Exclusion Criteria:

History of overt psychosis, severe hypertension as defined by Systolic Blood Pressure > 180 mm Hg or Diastolic Blood Pressure >110 mm Hg, unstable angina, Coronary Artery Disease, Congestive Heart Failure, porphyrias, thyroid disease, seizure disorder, inability to provide informed consent: dementia, non-English/Spanish speakers, subjects in custody, suicidal, or clinically intoxicated.
Intervention: Sitagliptin
Trial phase: Phase 4
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Sitagliptin will be administered orally in pill form at 100 mg, daily for 12 weeks.

Sitagliptin
Eligibility criteria:
Major Inclusion Criteria:

Symptomatic stable heart failure (New York Heart Association (NYHA) functional classification II-III) with reduced left ventricular ejection fraction (LVEF) ≤40%
Peak exercise limited by shortness of breath and associated with a respiratory exchange ratio (RER) >1.00 (reflecting maximal aerobic effort);
Poorly controlled Type 2 Diabetes Mellitus (T2DM)(HbA1c levels between 7.0% and 10.0% if on a treatment regimen including insulin, or between 6.5% and 10.0% if not on an insulin regimen);
Eighteen years of age or older.

Major Exclusion Criteria:

Type I diabetes;
Open label treatment with Sodium-GLucose coTransporter (SGLT)-2 inhibitors (within the past 3 months);
Current treatment with thiazolidinedione (within the past 3 months);
Chronic Renal Disease defined as Glomerular Filtration Rate (GFR) <50 ml•min-1/1.73m2 according to local laboratory
Pregnancy or of child-bearing potential or lactating;
Active or recent (within 2 weeks) genital/urinary infection;
Concomitant conditions or treatment which would affect completion or interpretation of the study (i.e, physical inability to walk or run on a treadmill
Inability to give informed consent.

Exclusion criteria specific to the cardiac magnetic resonance (CMR) substudy.

Estimated GFR <60 ml•min-1/1.73m2
Implantable cardioverter defibrillator, pacemaker or other implantable metal device not compatible with CMR scanning;
Severe claustrophobia, inability to lay flat for up to 60 minutes, or other contraindication to CMR scanning.
Intervention: 2,2-Dimethyl-4-(chloromethyl)-1,3-dioxa-2-silacyclopentane
Trial phase: Not Applicable
SMILES: C[Si]1(C)OCC(CCl)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.

Standard of Care: Institutional SOC for pain management will be followed.
Eligibility criteria:
Inclusion Criteria:

Age 18 - 85 years male or female
Patients undergoing unilateral thoracotomy cardiac procedures (with the exception of Aortic Aneurysm repair as sole treatment)
Acceptable surgical candidate, including use of general anesthesia
Willing and able to provide written informed consent
Willing and able to return for scheduled follow-up visits

Exclusion Criteria:

Cardiac valve surgical procedure via conventional full sternotomy
Procedures that require a posterolateral thoracotomy
Current pregnancy
Current use of prescription opioids
FEV1 < 40% predicted
Documented myocardial infarction within 30 days of signing Informed Consent Form (ICF)
Documented psychiatric disease
Documented chronic pain syndrome
Documented history of substance abuse
Patient currently enrolled in another research study that could directly affect results of either study
Physical or mental condition that would interfere with patient's self-assessment of pain
Disqualifying medical condition per investigator