anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
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: Child | Adult
Healthy volunteers: No
Participants at risk: 161
Group description: Participants were randomized to receive a single oral dose of ibuprofen 400 mg on Day 1. Participants were followed up to 17 days after the last dose of study drug.
Eligibility criteria:
Inclusion Criteria:

Males and females 16 years to 40 years of age (inclusive).
Subjects who have undergone outpatient surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction within 30 days of Screening and have met baseline pain criteria as described in this protocol
Examined by the attending dentist or physician and medically cleared to participate in the study.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, metabolic or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) determined by the Investigator to place the subject at increased risk including the presence or history within 2 years of screening of the following medical conditions/disorders:

Bleeding disorder;
Gastrointestinal ulcer or gastrointestinal bleeding;
Paralytic ileus or other gastrointestinal obstructive disorders.
Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception
Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID, caffeine, or other component of the product.
Intervention: Dihomo-gamma-linolenic acid
Trial phase: Phase 2
SMILES: CCCCC/C=C\C/C=C\C/C=C\CCCCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: 1g DS107 (2 DS107 capsules and 2 placebo capsules) orally administered once-daily for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects with a clinically confirmed diagnosis of active Atopic Dermatitis according to Hanafin and Rajka criteria
Subjects with moderate to severe Atopic Dermatitis at baseline as defined by an IGA of minimum 3 at baseline
Subjects with Atopic Dermatitis covering a minimum 10% of the body surface area at baseline
Male or female subjects who are aged 18 years and older on the day of signing the informed consent form (ICF)

Exclusion Criteria:

Subjects with other skin conditions that might interfere with Atopic Dermatitis diagnosis and/or evaluation (such as psoriasis or current active viral, bacterial and fungal skin infections) as assessed by the Investigator
Subjects who have used systemic treatments (other than biologics) that could affect Atopic Dermatitis less than 4 weeks prior to baseline visit (Day 0), e.g. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids. Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions are allowed
Subjects who have used any topical medicated treatment for Atopic Dermatitis two weeks prior to start of treatment/Baseline (Day 0), including but not limited to, topical corticosteroids, tars and bleach
Subjects who use topical products containing urea, ceramides or hyaluronic acid two weeks prior to Baseline
Subjects who have a history of hypersensitivity to any substance in Oral DS107 or placebo capsules
Subjects who have any clinically significant controlled or uncontrolled medical condition or laboratory abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with the interpretation of study results
Subjects with significant uncontrolled cardiovascular, neurologic, malignant, psychiatric, respiratory or hypertensive disease, as well as diabetes and arthritis or any other illness that, in the opinion of the investigator, is likely to interfere with completion of the study
Subjects with chronic infectious disease (e.g. hepatitis B, hepatitis C or infection with human immunodeficiency virus)
Intervention: Dihomo-gamma-linolenic acid
Trial phase: Phase 2
SMILES: CCCCC/C=C\C/C=C\C/C=C\CCCCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 112
Group description: 2g DS107 (4 DS107 capsules) orally administered once-daily for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects with a clinically confirmed diagnosis of active Atopic Dermatitis according to Hanafin and Rajka criteria
Subjects with moderate to severe Atopic Dermatitis at baseline as defined by an IGA of minimum 3 at baseline
Subjects with Atopic Dermatitis covering a minimum 10% of the body surface area at baseline
Male or female subjects who are aged 18 years and older on the day of signing the informed consent form (ICF)

Exclusion Criteria:

Subjects with other skin conditions that might interfere with Atopic Dermatitis diagnosis and/or evaluation (such as psoriasis or current active viral, bacterial and fungal skin infections) as assessed by the Investigator
Subjects who have used systemic treatments (other than biologics) that could affect Atopic Dermatitis less than 4 weeks prior to baseline visit (Day 0), e.g. retinoids, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids. Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions are allowed
Subjects who have used any topical medicated treatment for Atopic Dermatitis two weeks prior to start of treatment/Baseline (Day 0), including but not limited to, topical corticosteroids, tars and bleach
Subjects who use topical products containing urea, ceramides or hyaluronic acid two weeks prior to Baseline
Subjects who have a history of hypersensitivity to any substance in Oral DS107 or placebo capsules
Subjects who have any clinically significant controlled or uncontrolled medical condition or laboratory abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with the interpretation of study results
Subjects with significant uncontrolled cardiovascular, neurologic, malignant, psychiatric, respiratory or hypertensive disease, as well as diabetes and arthritis or any other illness that, in the opinion of the investigator, is likely to interfere with completion of the study
Subjects with chronic infectious disease (e.g. hepatitis B, hepatitis C or infection with human immunodeficiency virus)
Intervention: Glyburide
Trial phase: Phase 3
ATC code: A10BB01
SMILES: COc1ccc(Cl)cc1C(=O)NCCc1ccc(S(=O)(=O)NC(=O)NC2CCCCC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 259
Group description: Participants were administered with BIIB093 as an IV bolus followed by continuous IV infusion for over 72 hours.
Eligibility criteria:
Inclusion Criteria:

A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory.
A large hemispheric infarction defined as; lesion volume of 80 to 300 centimeters cubed (cm^3) on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP), or an Alberta Stroke Program Early CT Score (ASPECTS) of 1 to 5 with involvement of at least 2 defined cortical regions.
Screening National Institutes of Health Stroke Scale (NIHSS) >=10.

At the time of randomization, and in the Investigator's judgement, it must be feasible for study drug treatment infusion to be initiated no later than 10 hours after time of symptom onset, if known, or the time last known normal.

Participants who wake with stroke may be included if neurological and other exclusion criteria are satisfied. The time of stroke onset is to be taken as the midpoint between sleep onset (or last known to be normal) and time of waking.
For participants who receive thrombectomy, inclusion into the study must be based on post-thrombectomy MRI-DWI.

Exclusion Criteria:

Participant is likely to have supportive care withdrawn on the first day.
Commitment to decompressive craniectomy (DC) prior to enrollment.
Evidence of concurrent infarction in the contralateral hemisphere sufficiently serious so as to affect functional outcome.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Intervention: Cetirizine
Trial phase: Phase 1 | Phase 2
ATC code: R06AE07 | R06AE09 | S01GX12
SMILES: O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: 10mg oral each day for 1 year
Eligibility criteria:
Inclusion Criteria:

18 years to 85
Meet criteria for the diagnosis of neuromyelitis optica as outlined by Wingerchuk et al in 2006. Alternatively patients may be included if they have had an episode of myelitis or optic neuritis in combination with a positive NMO IgG antibody, as positive antibody with a first episode is highly associated with future relapse.
Disease duration of at least 6 months
Stable, without any NMO relapses, for the 3 months prior to the baseline assessment visit
Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.

Exclusion Criteria:

Current therapy with daily cetirizine or another daily antihistamine for any indication
Known hypersensitivity to cetirizine, hydroxyzine, or any component of the formulation
Change in NMO disease-modifying therapy in the 3 months prior to baseline assessment
Pregnancy or planning pregnancy during the study period
Severe renal or hepatic impairment
Inability to complete the study protocol for any reason
Intervention: ACARBOSE
Trial phase: Phase 2
ATC code: A10BD17 | A10BF01
SMILES: [H]C(=O)[C@H](O)[C@@H](O)[C@]([H])(O[C@@]1([H])O[C@H](CO)[C@@]([H])(O[C@H]2O[C@H](C)[C@@H](N[C@@]3([H])C=C(CO)[C@@H](O)[C@H](O)[C@H]3O)[C@H](O)[C@H]2O)[C@H](O)[C@H]1O)[C@H](O)CO
Sex: All
Age groups: Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: all participants will receive acarbose

acarbose: acarbose treatment with meals
Eligibility criteria:
Inclusion Criteria:

age 70-95
participants will be in good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable.
participants must have adequate cognitive function to be able to give informed consent. This will be established by enrolling participants with CLOX 1 scores of ≥10.

Exclusion Criteria:

unstable ischemic heart disease
clinically significant pulmonary disease
history of immunodeficiency or receiving immunosuppressive therapy
history of a coagulopathy or receiving a medical condition requiring anticoagulation
an estimated glomerular filtration rate of <30ml/min
uncontrolled hypercholesteremia >350mg/dl;
uncontrolled hypertriglyceridemia >500mg/dl
diabetes
history of skin ulcers or poor wound healing
smoking
liver disease treatment with drugs known to affect cytochrome P450 3A (diltiazem, erythromycin)
Intervention: Vadadustat
Trial phase: Phase 3
ATC code: B03XA08
SMILES: O=C(O)CNC(=O)c1ncc(-c2cccc(Cl)c2)cc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 179
Group description: Participants were randomized to receive Vadadustat at an initial oral dose of 300 milligrams per day (mg/day). Thereafter, Vadadustat was taken once daily on an outpatient basis. Up-and-down titration to 150, 300, 450, and 600 mg (available tablet strength was administered as the appropriate number of 150 mg tablets) was allowed during the study based on hemoglobin (Hb) level measurements to maintain target Hb levels.
Eligibility criteria:
Inclusion Criteria:

≥18 years of age
Initiated chronic maintenance dialysis (either peritoneal or hemodialysis) for end-stage kidney disease within 16 weeks prior to Screening
Mean Screening hemoglobin between 8.0 and <11.0 grams per deciliter (g/dL) (inclusive)
Serum ferritin ≥100 nanograms per deciliter (ng/mL) and TSAT ≥20% during Screening

Exclusion Criteria:

Anemia due to a cause other than chronic kidney disease or participants with active bleeding or recent blood loss
Red blood cells transfusion within 8 weeks prior to randomization
Anticipated to recover adequate kidney function to no longer require dialysis
Uncontrolled hypertension
Severe heart failure at Screening (New York Heart Association Class IV)
Acute coronary syndrome (hospitalization for unstable angina, myocardial infarction); surgical or percutaneous intervention for coronary, cerebrovascular, or peripheral artery disease (aortic or lower extremity); surgical or percutaneous valvular replacement or repair; sustained ventricular tachycardia; hospitalization for congestive heart failure; or stroke within 12 weeks prior to or during Screening.

Participants meeting the criteria of erythropoiesis-stimulating agent resistance within 8 weeks prior to or during Screening defined as follows

epoetin: > 7700 units/dose three times per week or >23,000 units per week
Darbepoetin alfa: >100 micrograms per week (mcg/week)
methoxy polyethylene glycol-epoetin beta: >100 micrograms (mcg) every other week or >200 mcg/month
Hypersensitivity to Vadadustat, Darbepoetin alfa or any of their excipients
Intervention: Pavinetant
Trial phase: Phase 2
SMILES: CC[C@H](NC(=O)c1c(NS(C)(=O)=O)c(-c2ccccc2)nc2ccccc12)c1ccccc1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Treatment with 1 tablet of MLE4901 self-administered twice daily [80% treated with dose of 40 mg twice daily]
Eligibility criteria:
Inclusion Criteria:

Oligo-/amenorrhea

At least one of the following during Screening:

Clinical signs of hyperandrogenism, where clinical hyperandrogenism may include hirsutism (defined as excessive terminal hair that appears in a male pattern), acne, or androgenic alopecia
Biochemical hyperandrogenism refers to an elevated serum androgen level (i.e., total, bioavailable or free testosterone level ≥ULN)
Polycystic ovarian morphology, defined as the presence of 12 or more follicles 2-9 mm in diameter and/or an increased ovarian volume >10 mL (without a cyst or dominant follicle) in either ovary
Body mass index (BMI) 22 to 45 kg/m2, inclusive
Must be willing to avoid use of all hair removal procedures and products during study participation
Must be willing to avoid all prescription treatments for acne and not increase the dose or frequency of their current non-prescription acne treatment regimen during study participation
Must be willing to avoid the use of all hair growth procedures and products during study participation
Permanently surgically sterilized (bilateral salpingectomy or tubal occlusion) >2 years or male partner(s) has had a vasectomy >2 years or must consent to use two permitted medically-acceptable methods of contraception throughout the study during any sexual intercourse with a male partner. Permitted medically-acceptable methods of birth control for this study are defined as use of a male condom plus one of the following: spermicide, diaphragm with spermicide, or an intrauterine device that does not contain steroid hormones.

Exclusion Criteria:

Menopausal or peri-menopausal, defined for this study as FSH (follicle stimulating hormone ) >10 IU/L
Irregular vaginal/menstrual bleeding caused by conditions other than PCOS (e.g., uterine polyps or submucosal uterine fibroids)
Abnormal Papanicolaou (Pap) test during Screening requiring follow-up sooner than 1 year after the test
Uncontrolled hypo- or hyperthyroidism
Post-hysterectomy or endometrial ablation
Post-oophorectomy (unilateral or bilateral) or other ovarian surgery
Medical history of type 1 or type 2 diabetes mellitus
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Placebo injection on operated side, same technique as experimental group.

Normal Saline: Same injection technique as intervention arm with normal saline
Eligibility criteria:
Inclusion Criteria:

ASA I-III.
Undergoing outpatient breast surgery requiring general anesthesia, including but not limited to mastectomy, lumpectomy, reconstruction with tissue expanders or implants and reconstruction revision.

Exclusion Criteria:

Unable to provide informed consent.
Patients who are pregnant or nursing.
ASA IV-V.
Alcohol or narcotic dependence in the last 2 years.
Concurrent condition requiring regular use of analgesia that may confound post-surgical assessments as determined by principle investigator.
Hepatic disease.
Allergies to amide anesthetics as determined from medical history or patient self-report.
Evidence of infection at injection site.
Contraindication to pain medications such as acetominophen, morphine, oxycodone, keterolac, dilaudid, Toradol.
Body weight <50kg.
BMI>40kg/m2.
History of hypotension.
Abnormal renal (creatinine > 1.5 mg/dL) function.
Heart block.
Any physical, mental or medical condition, that in the opinion of the investigator, makes study participation inadvisable.
Intervention: Ledipasvir
Trial phase: Phase 2
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 19
Group description: LDV/SOF 90/400 mg FDC orally once daily for 12 weeks
Eligibility criteria:
Key Inclusion Criteria:

Aged 12 to <18 years
Parent or legal guardian must provide written informed consent
Treatment naïve or experienced children with genotype 1 or 4 HCV infection, and are on a maintenance cancer chemotherapy regimen
Receiving a protocol-approved maintenance chemotherapy regimen for a hematological malignancy
Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
Screening laboratory values within defined thresholds
No History of solid organ or bone marrow transplantation
No history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Intervention: SECRETIN
Trial phase: Not Applicable
ATC code: V04CK01
SMILES: CC(C)C[C@H](NC(=O)CNC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](C)NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(=O)N[C@H](C(N)=O)C(C)C
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: MRCP with Secretin and MR elastography will be performed on all participants.

Secretin
Eligibility criteria:
Inclusion Criteria:

Subjects between the ages of 6 and 15.9 years.
Subjects without a documented history of (or suggestive of) pancreatic disease

Exclusion Criteria:

History of pancreatic disease, liver disease, intra-abdominal neoplasm, abdominal inflammatory process such as inflammatory bowel disease (IBD), or systemic illness that may affect pancreatic state (e.g. cystic fibrosis).
Subjects with surgical hardware/implanted devices making them ineligible for MRI (e.g. pacemaker or other implanted medical device not approved for MRI).
Subjects who require any form of sedation or general anesthesia for MRI.
Subjects unable to breath-hold for the required 15-20 second imaging sequence.
Subjects who are pregnant or less than 12 months post-partum.
Intervention: VALPROIC ACID
Trial phase: Phase 4
ATC code: N03AG01
SMILES: CCCC(CCC)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 107
Group description: Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).

Group (B) Started Valproic Acid (1000mg-1500mg).

Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.

First step: Monotherapy with Valproic Acid (1000mg-1500mg) Non responsive patients: 2nd step.
Second step: Association with lithium (900mg-1500mg). Non responsive patients: 3rd step.
Third step: Crossover: lithium (900mg-1500mg) + carbamazepine (600mg-1200mg). Non responsive patients: 4th step.
Fourth step: Association with risperidone (1-6mg)

Valproic Acid
Eligibility criteria:
Inclusion Criteria:

ages between 18 and 65;
BD current acute mixed episode;
total capacity to understand and respond to self-applied instruments;
the presence of symptoms in the last 30 days;
abstinence for at least 30 days for drug addicts.

Exclusion Criteria:

presence of Organic Brain Syndrome (OBS);
pregnancy or lactation;
criteria for psychiatric hospitalization.
Intervention: Carbamazepine
Trial phase: Phase 4
ATC code: N03AF01
SMILES: NC(=O)N1c2ccccc2C=Cc2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 107
Group description: Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).

Group (C) Started Carbamazepine (600mg-1200mg).

Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.

First step: Monotherapy with Carbamazepine (600mg-1200mg). Non responsive patients: 2nd step.
Second step: Association with lithium (900mg-1500mg). Non responsive patients: 3rd step.
Third step: Crossover: lithium (900mg-1500mg) + valproic acid (1000mg-1500mg). Non responsive patients: 4th step.
Fourth step: Association with risperidone (1-6mg)

Carbamazepine
Eligibility criteria:
Inclusion Criteria:

ages between 18 and 65;
BD current acute mixed episode;
total capacity to understand and respond to self-applied instruments;
the presence of symptoms in the last 30 days;
abstinence for at least 30 days for drug addicts.

Exclusion Criteria:

presence of Organic Brain Syndrome (OBS);
pregnancy or lactation;
criteria for psychiatric hospitalization.