anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Modafinil
Trial phase: Phase 4
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: 114
Group description: 50-400 mg per day (oral)

Modafinil: Modafinil is a safe, well-tolerated and effective wake-promoting agent (oral medication) that is FDA-approved for the treatment of fatigue related to sleep disorders. Modafinil is also one of the most commonly used medications for multiple sclerosis related fatigue in clinical practice, with doses ranging from 50 - 400 mg per day, in divided doses (once to twice daily).
Eligibility criteria:
Inclusion Criteria:

Patients with clinically definite Multiple Sclerosis (MS, all MS subtypes);
Age 18 years or older;
Presence of chronic, problematic fatigue that, in the opinion of the patient, has interfered with their daily activities for ≥ 3 months;
Average Fatigue Severity Scale (FSS) score greater or equal to 4 at screening.

Exclusion Criteria:

Current shift work sleep disorder, or narcolepsy diagnosed with polysomnography and multiple sleep latency test
History of MS relapse within the last 30 days prior to screening (participants will be considered eligible after the 30-day window);
Current stimulant or wake-promoting agent use (such as amantadine, modafinil, methylphenidate, or amphetamine) within 30 days of screening;
Pregnancy or breastfeeding;
Reliance on hormonal contraception AND concomitant unwillingness to use alternative non-hormonal means of birth control (spermicide or condoms) during the course of the study;
Current suicidal ideation (SI) with intent or plan;
Known hypersensitivity to modafinil or armodafinil or its inactive ingredients;
History of the following cardiovascular conditions: recent myocardial infarction (last 6 months prior to screening), unstable angina, left ventricular hypertrophy, mitral valve prolapse, NYHA class III or IV congestive heart failure;
History of prescription or illicit stimulant abuse (such as cocaine, amphetamine, methamphetamine);
Any other medical, neurological, or psychiatric condition that, in the opinion of the investigators, could affect participant safety or eligibility.
Intervention: Epclusa
Trial phase: Phase 4
ATC code: J05AP55
SMILES: CC(C)OC(=O)C(C)NP(=O)(OCC1OC(n2ccc(=O)[nH]c2=O)C(C)(F)C1O)Oc1ccccc1.COCC1CC(c2ncc(-c3ccc4c(c3)COc3cc5c(ccc6[nH]c(C7CCC(C)N7C(=O)C(NC(=O)OC)C(C)C)nc65)cc3-4)[nH]2)N(C(=O)C(NC(=O)OC)c2ccccc2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Eight weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret or Epclusa)

Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks: 8 weeks of direct acting antiviral treatment based on clinical indication (either Mavyret or Epclusa)
Eligibility criteria:
Inclusion Criteria:

Met MGH transplant center criteria, listed for lung transplant
Able to sign informed consent

Exclusion Criteria:

Pregnant or nursing (lactating) women
HIV positivity
Any contra-indication to lung transplantation per center protocol
For study patients in whom Epclusa® therapy is being considered, exclusion criteria includes patients on the following p-glycoprotein inducers or moderate to potent CYP inducers that cannot stop therapy: carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, rifapentine, St. John's wort.
For study patients in whom MavyretTM therapy is being considered, exclusion criteria includes patients on the following medications who cannot stop therapy: carbamazepine, rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives.
Intervention: Parsaclisib
Trial phase: Phase 2
ATC code: L01EM05
SMILES: CCOc1c([C@H](C)n2nc(C)c3c(N)ncnc32)cc(Cl)c(F)c1[C@@H]1CNC(=O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: parsaclisib was administered orally once a day.
Eligibility criteria:
Inclusion Criteria:

Primary SS diagnosed according to the revised American-European Consensus Group (AECG) criteria.
Minimum score of 2 on the SGUS score for parotid and submandibular glands.
EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥ 5.
Positive serum titers of anti-SS-A and/or anti-SS-B antibodies.
Symptomatic oral dryness score of at least 5 on patient questionnaire.
Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.

Exclusion Criteria:

Diagnosis of secondary SS according to the revised AECG criteria (eg, the presence of a previously diagnosed or a present diagnosis of rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, mixed connective tissue disease, polymyositis, dermatomyositis, immunoglobulin G4-related disorder, sarcoidosis, or any other defined autoimmune rheumatologic disorder).
Concurrent conditions and history of other diseases per protocol-defined criteria.
Positive test results for tuberculosis (TB) from the QuantiFERON-TB Gold test or T-spot.TB test.
Positive serology test results for HIV antibody, hepatitis B surface antigen, hepatitis B surface antigen antibody, HBV core antibody, or HCV (HCV antibody with positive HCV-RNA).
Severely impaired liver function (Child-Pugh Class C).
Prior or ongoing therapy with protocol-defined drugs.
Receipt of any live vaccine in the 30 days before screening.
No major surgery within 30 days before screening. Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
Current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the dose regimen and study evaluations.
Laboratory values at screening outside the protocol-defined ranges.
Intervention: Pibrentasvir
Trial phase: Phase 4
ATC code: J05AP57
SMILES: COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1nc2cc([C@H]3CC[C@H](c4cc5nc([C@@H]6CCCN6C(=O)[C@@H](NC(=O)OC)[C@@H](C)OC)[nH]c5cc4F)N3c3cc(F)c(N4CCC(c5ccc(F)cc5)CC4)c(F)c3)c(F)cc2[nH]1)[C@@H](C)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Participants who receive a kidney from HCV RNA PCR + deceased donor will receive 300 mg glecaprevir/pibrentasivir 120 mg once daily by mouth for 4 weeks

300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
Eligibility criteria:
Recipient Inclusion Criteria

Participants ≥ 40 years old
On the deceased donor kidney waitlist at Johns Hopkins Hospital
Awaiting a first or second kidney transplant
No available living kidney donors
On hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease defined as a glomerular filtration rate <15 ml/min for ≥ past 90 days
HCV-uninfected (by both antibody and RNA PCR) and without any behavioral risk factors for contracting HCV other than being on hemodialysis
Calculated panel reactive anti-human leukocyte antigen antibody (cPRA) below 80%

Recipient Exclusion Criteria

Plan to receive a multi-organ transplant
Plan to receive a dual kidney transplant (including en bloc)
Prior solid organ transplant
Participating in another study that involves an intervention or investigational product
Plan to receive a blood type incompatible kidney
History of human immunodeficiency (HIV), hepatitis C (HCV), or active hepatitis B (HBV) infection, defined as being on active antiviral treatment for HBV, detectable hepatitis B surface Ag or detectable hepatitis B DNA
Unable to safely substitute or discontinue a medication that is contraindicated with the study medication
Psychiatric or physical illness that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study
Intervention: Linagliptin
Trial phase: Phase 1
ATC code: A10BD11 | A10BD19 | A10BD27 | A10BH05
SMILES: CC#CCn1c(N2CCC[C@@H](N)C2)nc2c1c(=O)n(Cc1nc(C)c3ccccc3n1)c(=O)n2C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 29
Group description: Participants were administered 2 FDC coated tablets of 5 mg empagliflozin/ 2.5 mg linagliptin/ 1000 mg metformin XR orally as a single dose in the fed state.
Eligibility criteria:
Inclusion Criteria:

Healthy male or female subjects according to the assessment of the investigator, based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), Pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 55 years (incl.)
Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
Female subjects of childbearing potential willing to use adequate contraception.
Further inclusion criteria apply

Exclusion criteria:

Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease judged as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
Further exclusion criteria apply
Intervention: BALOXAVIR MARBOXIL
Trial phase: Phase 3
ATC code: J05AX25
SMILES: [H][C@@]12COCCN1C(=O)c1c(OCOC(=O)OC)c(=O)ccn1N2[C@@H]1c2ccccc2SCc2c1ccc(F)c2F
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 115
Group description: Participants will receive a single oral dose of baloxavir marboxil on Day 1 (based on body weight). Oseltamivir matching placebo will also be administered orally twice daily (BID) for 5 days.
Eligibility criteria:
Inclusion Criteria:

Aged 1 to < 12 years at randomization (Day 1).
Written informed consent/assent for study participation obtained from participant's parents or legal guardian, with assent as appropriate by the participant, depending on the patient's level of understanding
Participant able to comply with study requirements, depending on the patient's level of understanding
Participant with a diagnosis of influenza virus infection confirmed by the presence of all of the following:
Fever ≥ 38 degree celsius (tympanic temperature) at screening
At least one respiratory symptom (either cough or nasal congestion)
The time interval between the onset of symptoms and screening is ≤ 48 hours

Exclusion Criteria:

Severe symptoms of influenza virus infection requiring inpatient treatment
Concurrent infections requiring systemic antiviral therapy at screening
Require, in the opinion of the investigator, any of the prohibited medication during the study
Previous treatment with peramivir, laninamivir, oseltamivir, zanamivir, or amantadine within 2 weeks prior to screening
Immunization with a live/attenuated influenza vaccine in the 2 weeks prior to randomization
Concomitant treatment with steroids or other immuno-suppressant therapy
Known HIV infection or other immunosuppressive disorder
Uncontrolled renal, vascular, neurologic, or metabolic disease (e.g., diabetes, thyroid disorders, adrenal disease), hepatitis, cirrhosis, or pulmonary disease or participants with known chronic renal failure.
Active cancer at any site
History of organ transplantation
Known allergy to either study drug (i.e., baloxavir marboxil and oseltamivir) or to acetaminophen
Females with child-bearing potential
Participation in a clinical trial within 4 weeks or five half-lives of exposure to an investigational drug prior to screening, whichever is longer
Intervention: Oseltamivir
Trial phase: Phase 3
ATC code: J05AH02
SMILES: CCOC(=O)C1=C[C@@H](OC(CC)CC)[C@H](NC(C)=O)[C@@H](N)C1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 58
Group description: Participants will receive oseltamivir orally BID for 5 days (based on body weight). Baloxavir marboxil matching placebo will also be administered orally on Day 1
Eligibility criteria:
Inclusion Criteria:

Aged 1 to < 12 years at randomization (Day 1).
Written informed consent/assent for study participation obtained from participant's parents or legal guardian, with assent as appropriate by the participant, depending on the patient's level of understanding
Participant able to comply with study requirements, depending on the patient's level of understanding
Participant with a diagnosis of influenza virus infection confirmed by the presence of all of the following:
Fever ≥ 38 degree celsius (tympanic temperature) at screening
At least one respiratory symptom (either cough or nasal congestion)
The time interval between the onset of symptoms and screening is ≤ 48 hours

Exclusion Criteria:

Severe symptoms of influenza virus infection requiring inpatient treatment
Concurrent infections requiring systemic antiviral therapy at screening
Require, in the opinion of the investigator, any of the prohibited medication during the study
Previous treatment with peramivir, laninamivir, oseltamivir, zanamivir, or amantadine within 2 weeks prior to screening
Immunization with a live/attenuated influenza vaccine in the 2 weeks prior to randomization
Concomitant treatment with steroids or other immuno-suppressant therapy
Known HIV infection or other immunosuppressive disorder
Uncontrolled renal, vascular, neurologic, or metabolic disease (e.g., diabetes, thyroid disorders, adrenal disease), hepatitis, cirrhosis, or pulmonary disease or participants with known chronic renal failure.
Active cancer at any site
History of organ transplantation
Known allergy to either study drug (i.e., baloxavir marboxil and oseltamivir) or to acetaminophen
Females with child-bearing potential
Participation in a clinical trial within 4 weeks or five half-lives of exposure to an investigational drug prior to screening, whichever is longer
Intervention: Tranexamic acid
Trial phase: Phase 4
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 110
Group description: Tranexamic Acid: One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.
Eligibility criteria:
Inclusion Criteria:

-PATIENTS UNDERGOING AN ACL RECONSTRUCTION WITH BTB AUTOGRAFT

Exclusion Criteria:

Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
Younger than 18 years of age
Any patient considered a vulnerable subject
Have bleeding or clotting disorder
Preoperative anticoagulation therapy
Abnormal coagulation profile
Renal disorder or insufficiency
Sickle cell disease
Intervention: Ibuprofen
Trial phase: Phase 4
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 | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: A registered pharmacist compounded identical appearing tablets of 200 mg ibuprofen and tablets of 200 mg ibuprofen/216.7 mg acetaminophen. The tablets were placed in identical-appearing bottles (60 tabs of 200 mg ibuprofen or 60 tabs of a combination of 200 mg ibuprofen/216.7 mg acetaminophen). At the end of the debridement appointment, the patient received either a bottle containing 60 tabs of 200 mg ibuprofen or 60 tabs of 200 mg ibuprofen/216.7 mg acetaminophen. The patients were instructed to take 3 tablets every 6 hours as needed for pain.

Ibuprofen 600 mg: identical appearing tablets containing 600 mg of ibuprofen
Eligibility criteria:
Inclusion Criteria:

mandibular (bottom) or maxillary (top) posterior (back) tooth requiring root canal treatment
mandibular (bottom) or maxillary (top) posterior (back) tooth with symptomatic irreversible pulpitis and symptomatic apical periodontitis (painful tooth to cold and biting)

2. between the ages of 18 and 65 years of age 3. American Society of Anesthesiologist classification I

Exclusion Criteria:

patients younger than 18 or older than 65 years of age
American Society of Anesthesiologist classification II or higher
allergies or contraindications to ibuprofen
allergies or contraindications to acetaminophen
pregnancy
inability to give informed consent
Intervention: Silicon Dioxide
Trial phase: Phase 2
SMILES: O=[Si]=O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 145
Group description: 3 tablets as a single dose (210 mg х 3 = 630 mg) TID (630 mg х 3 = 1,890 mg)

Carbowhite
Eligibility criteria:
Inclusion Criteria:

signed Informed Consent Form for patient's study participation
male and female patients at the ages from 18 to 55 years
acute diarrhea (more than three episodes of liquid stool a day) within 48 hours or less in patients with usually normal stool
body temperature of ≤ 38 °C
patient's ability to adequately cooperate in the process of study

Exclusion Criteria:

aged of <18 or >55 years;
blood or pus in stool;
body temperature of >38 °C;
episodes of acute diarrhea for the last 30 days;
administration of antidiarrheal products for the last 24 hours;
salmonellosis (Salmonella of any serotype different from S. typhi and S. paratyphi; ICD-10: A02.0), dysentery (Shigella dysenteriae, Shigella flexneri, Shigella boydii; ICD-10: A03.0-A03.3), colibacillosis (Escherichia coli; ICD-10: A04.0-A04.4) which require administration of antimicrobial products;
pregnancy, lactation;
concomitant decompensated diseases or acute conditions which, according to an investigator, may affect study results
alcoholism and drug abuse;
participation in any other clinical study.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: These patients receive an interscalene block with liposomal bupivacaine.

liposomal bupivacaine: Experimental
Eligibility criteria:
Inclusion Criteria:

All patients age 18 years and older who are scheduled for shoulder surgery with interscalene block and remain in the hospital for more than 24 hours that are being randomized into a bupivacaine versus liposomal bupivacaine interscalene block study.

Exclusion Criteria:

Non English speaking patients.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: These patients receive an interscalene block with bupivacaine.

bupivacaine: Active comparator
Eligibility criteria:
Inclusion Criteria:

All patients age 18 years and older who are scheduled for shoulder surgery with interscalene block and remain in the hospital for more than 24 hours that are being randomized into a bupivacaine versus liposomal bupivacaine interscalene block study.

Exclusion Criteria:

Non English speaking patients.
Intervention: Ademetionine
Trial phase: Phase 2
ATC code: A16AA02
SMILES: C[S+](CC[C@H](N)C(=O)[O-])C[C@H]1O[C@@H](n2cnc3c(N)ncnc32)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered

A cycle consist of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily)

Repeated every 21st day

Two drug Chemotherapy: Oxaliplatin+TGO
Eligibility criteria:
Inclusion criteria:

Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.
Clinical stage: cTNM: stage III or above
Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day)
Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.
Written informed consent

Exclusion criteria:

Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia
Confirmed distant metastases
Locally advanced inoperable disease (Clinical assessment)
Relapse of gastric cancer
Malignant secondary disease
Prior chemo or radiotherapy
Inclusion in another clinical trial
Known contraindications or hypersensitivity for planned chemotherapy
Intervention: Lorcaserin
Trial phase: Early Phase 1
ATC code: A08AA11
SMILES: C[C@H]1CNCCc2ccc(Cl)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Lorcaserin XR 20mg daily

Lorcaserin: Lorcaserin XR 20mg per day
Eligibility criteria:
Inclusion Criteria:

Individuals between the ages of 18-70
Meets DSM-V criteria for a current cannabis use disorder
Seeking treatment for cannabis use disorder
THC-positive urine drug screen
Capable of giving informed consent and complying with study procedures
Has regular access to the internet by any means
Not underweight (Defined as BMI ≥18.5)

Exclusion Criteria:

Lifetime history of DSM-V diagnosis of schizophrenia or schizoaffective disorder
Current DSM-V criteria for a psychiatric disorder supported by the MINI that in the investigator's judgment is unstable, would be disrupted by the study medication, or is likely to require new pharmacotherapy or psychotherapy during the study period. Individuals who are currently stable on psychotropic medication for at least 3months may be included if in the investigator's opinion the psychotropic medication is compatible with the study medication (lorcaserin).
Individuals who meet DSM-V criteria for any moderate to severe substance use disorder other an cannabis, caffeine or nicotine use disorders
Pregnancy, lactation, or failure to use adequate contraceptive method in female patients who are currently engaging in sexual activity with men
Unstable medical conditions, such as AIDS, cancer, uncontrolled hypertension, uncontrolled diabetes, pulmonary hypertension or heart disease; or individuals with a history of serotonin syndrome
Legally mandated to participate in a substance use disorder treatment program
Current or recent history of significant violent or suicidal behavior, risk for suicide or homicide
Currently meets DSM-V diagnosis for an eating disorder or is underweight (BMI <18.5)
Elevated liver function tests (AST and ALT > 3 times the upper limit of normal) or impaired renal function
Known history of allergy, intolerance, or hypersensitivity to lorcaserin
Concurrent use of migraine medications ergotamine (Cafergot, Ergomar) or dihydroergotamine (Migranal), 5HT2B receptor agonists like cabergoline, medications metabolized by CYP2D6 (thioridazine, tamoxifen, metoprolol, aripiprazole, codeine,, MAOIs, or St. John's Wort