anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Acebilustat
Trial phase: Phase 2
SMILES: O=C(O)c1ccc(CN2CC3CC2CN3Cc2ccc(Oc3ccc(-c4ncco4)cc3)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: Participants receive acebilustat (100 mg/day) for 28 days.
Eligibility criteria:
Inclusion Criteria:

Outpatient setting
Age ≥ 18 years and ≤ 80 years at the time of the assessment
Able and willing to understand the study, adhere to all study procedures, and provide written informed consent
Initial diagnosis of COVID-19 disease as defined by an FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 with no more than 72 hours from the initial swab used in the diagnosis to the time of commencing informed consent.
At baseline, at least two symptoms should have mild or higher severity score, where at least one of the mild symptoms is not cough, fatigue, or loss of smell/taste OR at least one symptom has a moderate or higher severity score on the COVID Outpatient Symptom Scale (COSS).
Participant's COVID-19 related symptom onset occurred within 7 days prior to time of randomization.
Other inclusion criteria specific to the investigational product that may, in the eyes of the investigator, be deemed necessary.

Exclusion Criteria:

At screening, the participant needs to be admitted to the hospital or is being evaluated for potential admission.
Previous use of experimental drugs that may be active against COVID-19 in the eyes of the investigators.
Participant yields a positive urine pregnancy test at screening.

Participant is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers).

NOTE: Treatment of study participants following institutional COVID-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. This excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and NO, and co-enrollment into other clinical studies that evaluate investigational agents for COVID-19.

Participant has a serious chronic disease (e.g., uncontrolled human immunodeficiency virus [HIV], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency).
Has renal insufficiency including severe renal impairment and ESRD and/or requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Has liver impairment greater than Child Pugh A.
Has a history of alcohol or drug abuse in the previous 6 months.
Has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.
Has taken another investigational drug within the past 30 days.
Is deemed by the Investigator to be ineligible for any reason.
Additional exclusions may pertain to specific drugs as described in study-specific protocols.
Intervention: Camostat
Trial phase: Phase 2
ATC code: B02AB04
SMILES: CN(C)C(=O)COC(=O)Cc1ccc(OC(=O)c2ccc(NC(=N)N)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Participants receive camostat (800 mg/day) for 10 days.
Eligibility criteria:
Inclusion Criteria:

Outpatient setting
Age ≥ 18 years and ≤ 80 years at the time of the assessment
Able and willing to understand the study, adhere to all study procedures, and provide written informed consent
Initial diagnosis of COVID-19 disease as defined by an FDA-cleared molecular diagnostic assay positive for SARS-CoV-2 with no more than 72 hours from the initial swab used in the diagnosis to the time of commencing informed consent.
At baseline, at least two symptoms should have mild or higher severity score, where at least one of the mild symptoms is not cough, fatigue, or loss of smell/taste OR at least one symptom has a moderate or higher severity score on the COVID Outpatient Symptom Scale (COSS).
Participant's COVID-19 related symptom onset occurred within 7 days prior to time of randomization.
Other inclusion criteria specific to the investigational product that may, in the eyes of the investigator, be deemed necessary.

Exclusion Criteria:

At screening, the participant needs to be admitted to the hospital or is being evaluated for potential admission.
Previous use of experimental drugs that may be active against COVID-19 in the eyes of the investigators.
Participant yields a positive urine pregnancy test at screening.

Participant is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers).

NOTE: Treatment of study participants following institutional COVID-19 treatment policies or guidelines, including the use of immunomodulatory medications, is permitted. This excludes treatment with agents that have the potential for direct antiviral activity, including convalescent plasma and NO, and co-enrollment into other clinical studies that evaluate investigational agents for COVID-19.

Participant has a serious chronic disease (e.g., uncontrolled human immunodeficiency virus [HIV], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency).
Has renal insufficiency including severe renal impairment and ESRD and/or requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Has liver impairment greater than Child Pugh A.
Has a history of alcohol or drug abuse in the previous 6 months.
Has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year.
Has taken another investigational drug within the past 30 days.
Is deemed by the Investigator to be ineligible for any reason.
Additional exclusions may pertain to specific drugs as described in study-specific protocols.
Intervention: Prasugrel
Trial phase: Phase 4
ATC code: B01AC22
SMILES: CC(=O)Oc1cc2c(s1)CCN(C(C(=O)C1CC1)c1ccccc1F)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Prasugrel only administered at the start of PCI

Prasugrel: Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
Eligibility criteria:
Inclusion Criteria:

Patients with NSTE-ACS (UA or NSTEMI) undergoing PCI. NSTE-ACS will be defined as the presence of cardiac ischemic symptoms with ischemic changes (but not ST-segment elevation) on electrocardiogram with or without a positive troponin. However, normal electrocardiograms will be acceptable if the investigator will consider an ACS presentation likely.
Age between 18 and 75 years old

Exclusion Criteria:

Inability to provide written informed consent
Age >75 years
Weight <60 Kg
ST-segment elevation myocardial infarction
On treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel, ticagrelor) in past 7 days
Known allergies to prasugrel or cangrelor
Considered at high risk for bleeding
History of ischemic or hemorrhagic stroke or transient ischemic attack
On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxoban)
Planned treatment with glycoprotein IIb/IIIa inhibitors (only bailout use allowed)
Fibrinolytics within 24 hours
Known platelet count <80x106/mL
Known hemoglobin <10 g/dL
Active bleeding
Known end stage renal disease on hemodialysis
Known severe hepatic dysfunction
Intubated patients (prior to randomization)
Pregnant females [women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study]
Intervention: Odevixibat
Trial phase: Phase 3
ATC code: A05AX05
SMILES: CCCCC1(CCCC)CN(c2ccccc2)c2cc(SC)c(OCC(=O)N[C@@H](C(=O)N[C@@H](CC)C(=O)O)c3ccc(O)cc3)cc2S(=O)(=O)N1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Capsules for oral administration once daily for 24 weeks.

Odevixibat: Odevixibat is a small molecule and selective inhibitor of IBAT.
Eligibility criteria:
Key Inclusion Criteria:

Genetically confirmed diagnosis of Alagille syndrome
History of significant pruritus as measured by the Albireo Observer or Patient Reported Outcome instrument
Elevated serum bile acid level

Key Exclusion Criteria:

History or ongoing presence of other types of liver disease (eg. biliary atresia, progressive familial intrahepatic cholestasis, hepatocellular carcinoma)
History of liver transplant, or a liver transplant is planned within 6 months of randomization
ALT >10× upper limit of normal (ULN) at screening
Total bilirubin >15 × ULN at screening
Patient suffers from uncontrolled, recalcitrant pruritic condition other than Alagille syndrome
Intervention: 2-Methyl-6-{[(1S,2S)-2-(5-methylpyridin-2-yl)cyclopropyl]methoxy}-N-[(5-methyl-1,3,4-thiadiazol-2-yl)methyl]pyrimidin-4-amine
Trial phase: Phase 1
SMILES: Cc1ccc(C2CC2COc2cc(NCc3nnc(C)s3)nc(C)n2)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: Participants with moderate hepatic impairment received a single dose of MK-8189 4 mg orally on Day 1
Eligibility criteria:
Inclusion Criteria:

Is a continuous non-smoker or moderate smoker (of fewer than 20 cigarettes/day or equivalent)
Female participant is not pregnant or breastfeeding and is not woman of childbearing potential (WOCBP) or is a WOCBP using contraception or abstinent from heterosexual intercourse during the intervention period and for at least 14 days after the last dose of study intervention
(For hepatically impaired participants) Has a diagnosis of chronic (>6 months), stable (no acute episodes within the previous 2 months due to deterioration in hepatic function) hepatic impairment

Exclusion Criteria:

Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological abnormalities or diseases
Has a history of cancer; exceptions include (1) adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, (2) other successfully treated malignancies
Has a history of significant multiple and/or severe allergies or has had significant intolerability to prescription or non-prescription drugs or food
Is positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
Has had major surgery or lost 1 unit of blood within 4 weeks prior to prestudy visit
Consumes greater than 3 glasses of alcoholic beverages per day
Consumes greater than 6 servings (1 serving is ~120 mg of caffeine) caffeinated beverages per day
(For hepatically impaired participants) Is taking medications to treat chronic medical conditions and has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of the medications during study
Intervention: 2-Methyl-6-{[(1S,2S)-2-(5-methylpyridin-2-yl)cyclopropyl]methoxy}-N-[(5-methyl-1,3,4-thiadiazol-2-yl)methyl]pyrimidin-4-amine
Trial phase: Phase 1
SMILES: Cc1ccc(C2CC2COc2cc(NCc3nnc(C)s3)nc(C)n2)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: Healthy participants received a single dose of MK-8189 4 mg orally on Day 1.
Eligibility criteria:
Inclusion Criteria:

Is a continuous non-smoker or moderate smoker (of fewer than 20 cigarettes/day or equivalent)
Female participant is not pregnant or breastfeeding and is not woman of childbearing potential (WOCBP) or is a WOCBP using contraception or abstinent from heterosexual intercourse during the intervention period and for at least 14 days after the last dose of study intervention
(For hepatically impaired participants) Has a diagnosis of chronic (>6 months), stable (no acute episodes within the previous 2 months due to deterioration in hepatic function) hepatic impairment

Exclusion Criteria:

Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological abnormalities or diseases
Has a history of cancer; exceptions include (1) adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix, (2) other successfully treated malignancies
Has a history of significant multiple and/or severe allergies or has had significant intolerability to prescription or non-prescription drugs or food
Is positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
Has had major surgery or lost 1 unit of blood within 4 weeks prior to prestudy visit
Consumes greater than 3 glasses of alcoholic beverages per day
Consumes greater than 6 servings (1 serving is ~120 mg of caffeine) caffeinated beverages per day
(For hepatically impaired participants) Is taking medications to treat chronic medical conditions and has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of the medications during study
Intervention: Tamsulosin
Trial phase: Phase 4
ATC code: G01AE10 | G04CA02 | G04CA52 | G04CA53 | G04CA54
SMILES: CCOc1ccccc1OCCN[C@H](C)Cc1ccc(OC)c(S(N)(=O)=O)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Patients in this arm will receive 10 days of 0.4 mg of oral tamsulosin once daily starting 5 days pre-operatively and continuing until all pills are completed.

Tamsulosin: Oral drug: 10 days of 0.4 mg of oral Tamsulosin
Eligibility criteria:
Inclusion Criteria:

Stage II or greater pelvic organ prolapse in > 1 vaginal compartment
Plan for multicompartment native tissue vaginal repair (which would include any combination of uterosacral ligament suspension, sacrospinous ligament suspension, cystocele and/or rectocele repair, with or without hysterectomy and with or without concomitant mid-urethral sling) or vaginal closure with female pelvic medicine and reconstructive surgery (FPMRS) - trained surgeons at Wake Forest Baptist Health
Participation in Enhanced-Recovery-After-Surgery protocol with plan for same-day hospital discharge
Willing to remain compliant with Investigation Product (IP)

Exclusion Criteria:

Intraoperative complication necessitating prolonged bladder drainage or placement of a vaginal pack x 24 hours (patients would exit study after randomization and will be excluded from the per-protocol analysis)
Patients whose surgical plan would necessitate a voiding trial on postop day >0
Less than 21 years of age
Unable to understand English
Patients who are scheduled to undergo combined colorectal procedures such as rectopexy, sphincteroplasty
Patient with known allergy to Tamsulosin or sulfa drugs
Patients with upcoming cataract surgery
Patient with orthostatic hypotension
History of postvoid residual (PVR>150) prior to surgery with prolapse reduction
Patients with hypertension on alpha-blockers
Single compartment prolapse repair (anterior or posterior repair only)
Use of mesh for prolapse repair
High tone pelvic floor dysfunction
Intervention: Amlodipine
Trial phase: Phase 2
ATC code: C07FB07 | C07FB12 | C07FB13 | C08CA01 | C08CA17 | C08CA51 | C08GA02 | C09BB03 | C09BB04 | C09BB07 | C09BB13 | C09BX01 | C09BX03 | C09BX04 | C09DB01 | C09DB02 | C09DB04 | C09DB05 | C09DB06 | C09DB07 | C09DB09 | C09DX01 | C09DX03 | C09DX06 | C09DX07 | C09DX08 | C09XA53 | C09XA54 | C10BX03 | C10BX07 | C10BX09 | C10BX11 | C10BX14 | C10BX18 | C10BX19
SMILES: CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1c1ccccc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 124
Group description: Participants randomized to the early HTN treatment arm will initiate 5mg daily of amlodipine immediately, increasing to 10 mg if SBP >130 mmHg after 1 month.

Amlodipine 5mg: Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.
Eligibility criteria:
Inclusion Criteria:

PLWH 18-65 years of age
ART duration ≥ 1 year, stable regimen ≥ 6 months
HIV 1-RNA < 1,000 copies/mL within past 12 months
Pre-HTN (SBP 120-139 or DBP 80-89 mm Hg)
No current antihypertensive treatment
Receives HIV care at GHESKIO
Willing to provide consent

Exclusion Criteria:

Pregnancy
Kidney disease or diabetes
On protease inhibitor/ritonavir
Advanced illness with limited life expectancy
Plans to move out of the area within the next year
Clinician determination that patient is unstable on ART
Intervention: Gersizangitide
Trial phase: Phase 1 | Phase 2
SMILES: CCC(C)C(NC(=O)C(CC(=O)O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(C)NC(=O)C(Cc1ccccc1)NC(=O)C1CCCN1C(=O)C(C)NC(=O)C(NC(=O)C(CO)NC(=O)C(Cc1ccccc1)NC(=O)C(CCCNC(=N)N)NC(=O)C(CCCNC(=N)N)NC(=O)C(N)CC(C)C)C(C)O)C(C)CC)C(=O)NC(CC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC(C(=O)NC(C(=O)NC(CC(N)=O)C(=O)NC(Cc1ccccc1)C(N)=O)C(C)CC)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: AXT107 0.1 mg/eye

AXT107 0.1 mg: Single intravitreal injection of AXT107 0.1 mg/eye
Eligibility criteria:
Inclusion Criteria:

Patients 18 years of age or older with diabetic macular edema (DME) diagnosis secondary to diabetes mellitus Type 1 or 2
Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 65 to 23 in the study eye
Willing and able to comply with clinic visits and study-related procedures
Provide signed inform consent

Exclusion Criteria:

Any signs of high risk proliferative diabetic retinopathy in the study
Previously-treated patients who are not responders to anti-VEGF
Panretinal laser photocoagulation within 6 months and macular laser photocoagulation with 3 months of screening in the study eye

Note: Other inclusion/exclusion criteria apply.
Intervention: Gersizangitide
Trial phase: Phase 1 | Phase 2
SMILES: CCC(C)C(NC(=O)C(CC(=O)O)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(C)NC(=O)C(Cc1ccccc1)NC(=O)C1CCCN1C(=O)C(C)NC(=O)C(NC(=O)C(CO)NC(=O)C(Cc1ccccc1)NC(=O)C(CCCNC(=N)N)NC(=O)C(CCCNC(=N)N)NC(=O)C(N)CC(C)C)C(C)O)C(C)CC)C(=O)NC(CC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC(C(=O)NC(C(=O)NC(CC(N)=O)C(=O)NC(Cc1ccccc1)C(N)=O)C(C)CC)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: AXT107 0.25 mg/eye

AXT107 0.25 mg: Single intravitreal injection of AXT107 0.25 mg/eye
Eligibility criteria:
Inclusion Criteria:

Patients 18 years of age or older with diabetic macular edema (DME) diagnosis secondary to diabetes mellitus Type 1 or 2
Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 65 to 23 in the study eye
Willing and able to comply with clinic visits and study-related procedures
Provide signed inform consent

Exclusion Criteria:

Any signs of high risk proliferative diabetic retinopathy in the study
Previously-treated patients who are not responders to anti-VEGF
Panretinal laser photocoagulation within 6 months and macular laser photocoagulation with 3 months of screening in the study eye

Note: Other inclusion/exclusion criteria apply.
Intervention: Promega
Trial phase: Phase 2 | Phase 3
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)O.CCCC=CCC=CCC=CCC=CCC=CCCCC(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 2
Group description: Use of Omegaven for patients with parenteral nutrition associated liver disease.

Omegaven: Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day.
Eligibility criteria:
Inclusion Criteria:

The patient will be PN dependent and unable to meet nutritional needs solely by enteral nutrition.
Patient will be <18 years of age.
Direct bilirubin > 2.0mg/dl
The patient must have failed standard therapies to prevent progression his/her liver disease.

Exclusion Criteria:

Other causes of chronic liver disease (Hepatitis C, Cystic fibrosis, biliary atresia, and alpha 1 anti-trypsin deficiency).
Patients who are allergic to eggs/shellfish
Patients who have severe hemorrhagic disorders.
Intervention: Valproate Sodium
Trial phase: Phase 3
SMILES: CCCC(CCC)C(=O)[O-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: VPA is a well know antiepileptic drug with multiple side effects. However, in low doses are a few side effects problems.
Eligibility criteria:
Inclusion Criteria:

Men and women from 18 to 65 years old.
Diagnosis of migraine according to the ICHD-III of the IHS at least one year before the study.
You must have at least 4-14 migraine attacks per month.
Not receiving prophylactic treatment for migraine
Sign informed consent

Exclusion Criteria:

Pregnant or lactating patients.
Patients with another type of non-migraine headache.
Allergy to Sodium Valproate and/or Memantine
Being a carrier of systemic disease (infectious, immunological, or metabolic processes) or cardiovascular (myocardial, coronary, or valvular disease) prevents their participation in the study.
Intervention: Memantine
Trial phase: Phase 3
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: 16
Group description: Memantine is a tolerable drug. However, it is always necessary to ask for side effects in this type o research.
Eligibility criteria:
Inclusion Criteria:

Men and women from 18 to 65 years old.
Diagnosis of migraine according to the ICHD-III of the IHS at least one year before the study.
You must have at least 4-14 migraine attacks per month.
Not receiving prophylactic treatment for migraine
Sign informed consent

Exclusion Criteria:

Pregnant or lactating patients.
Patients with another type of non-migraine headache.
Allergy to Sodium Valproate and/or Memantine
Being a carrier of systemic disease (infectious, immunological, or metabolic processes) or cardiovascular (myocardial, coronary, or valvular disease) prevents their participation in the study.
Intervention: Kenalog
Trial phase: Phase 4
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation

Triamcinolone Acetonide 40mg/mL: Sub-tenon irrigation 1cc
Eligibility criteria:
Inclusion Criteria:

Patient must have rhegmatogenous retinal detachment and be scheduled to undergo scleral buckle surgery for correction

Exclusion Criteria:

Advanced Glaucoma
History of corticosteroid responsive elevation in IOP
Allergy to Triamcinolone Acetonide or other corticosteroids
Pre-existing chronic pain disorders
Herpes zoster
Prior corneal allograft
Allergy to local anesthetic or penicillin
Patients unable to consent on own behalf
Patients unable to communicate pain and nausea levels
Pregnancy
Incarceration