anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: FLUTICASONE PROPIONATE
Trial phase: Phase 2 | Phase 3
ATC code: D07AC17 | R01AD08 | R01AD58 | R03BA05
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Participants that fail to respond to 6FED in Phase 1 administer swallowed glucocorticoids (SGC) (Flovent HFA) 880 mcg twice daily in Phase 2

Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)
Eligibility criteria:
Inclusion Criteria:

Have diagnosis of EoE (based on consensus criteria)
Have histologically confirmed active disease >15 eosinophils/hpf in either distal or proximal esophagus within 12 weeks of screening visit
Symptomatic (have experienced symptoms within the last month prior to enrollment)
Proton pump inhibitor (PPI) confirmation
Have a negative urine pregnancy test at screening if of childbearing potential

Exclusion Criteria:

Have been treated with topical swallowed steroids within the last 2 months or systemic steroids within the last 3 months
Have pathological eosinophilia in segments of the GI tract other than the esophagus determined by local review
Have been diagnosed with a GI malabsorption disorder (i.e., Inflammatory bowel disease, Crohn's disease) or Celiac disease
Are currently on dietary therapy strictly avoiding milk or on a 6FED
Have concurrent H pylori gastritis or parasitic infection
Have history of anaphylaxis to milk (with current avoidance of milk)
Have previously failed strict dietary therapy clearly documented with one of these regimens or topical steroid treatment (i.e. have achieved histological remission of <15 eos/hpf after having been on fluticasone or >1mg budesonide per day).
Use of investigational drugs within 4 weeks (one month) prior to enrollment
Are concurrently receiving any of the prohibited medications for the study
On immunotherapy for pollen (if not on maintenance therapy) or immunoglobulin-E (IgE) -mediated food allergy
Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
Intervention: Ketamine
Trial phase: Phase 3
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 44
Group description: Ketamine 1.5 mg/kg intranasally for one dose
Eligibility criteria:
Inclusion Criteria:

8 years to 17 years (up to the 18th birthday)
Presenting to emergency department with one or more extremity injuries
Visual analog scale score 35 mm or greater
Parent or legal guardian present and willing to provide written consent

Exclusion Criteria:

Received narcotic pain medication prior to arrival
Evidence of significant head, chest, abdomen, or spine injury
Glasgow coma score less than 15 or unable to self report pain score
Nasal trauma or aberrant nasal/airway anatomy
Active epistaxis
Allergy to ketamine, fentanyl or meperidine
Non-English speaking parent and/or child
History of psychosis
Postmenarchal female without a urine or serum assay documenting the absence of pregnancy
Brought in my juvenile detention center or in police custody
Pregnancy
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: 0.9% NaCL (saline) intravenously for 6 hours.

Saline: Subjects will be studied on 2 occasions, in random order. During the saline study they will be infused with saline.
Eligibility criteria:
Inclusion Criteria:

Undergone either sleeve gastrectomy or Roux-en-Y Gastric Bypass surgery within prior 2 years
Healthy, with no active systemic illness

Exclusion Criteria:

Pregnancy
Functional or organic bowel symptoms
Systemic illness
Diabetes
Bariatric surgery > 2 years
Intervention: Celecoxib
Trial phase: Not Applicable
ATC code: C08CA51 | G01AE10 | L01XX33 | M01AH01 | N02AJ16
SMILES: Cc1ccc(-c2cc(C(F)(F)F)nn2-c2ccc(S(N)(=O)=O)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 98
Group description: 50 patients received 400mg celecoxib prior to surgery

Celecoxib: Received 400mg celecoxib prior to surgery
Eligibility criteria:
Inclusion Criteria:

All patients who are undergoing a hip arthroscopy procedure at Northwestern Memorial Hospital with Dr. Michael Terry.

Exclusion Criteria:

Pregnant women and any patient under the age of 18 years.
Intervention: Setipiprant
Trial phase: Phase 2
SMILES: O=C(O)Cn1c2c(c3cc(F)ccc31)CN(C(=O)c1cccc3ccccc13)CC2
Sex: Male
Age groups: Adult
Healthy volunteers: No
Participants at risk: 81
Group description: Setipiprant 1000 mg (2 X 500 mg) tablets, orally, BID at 12-hour intervals for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Participant has androgenetic alopecia (AGA)
Participant agrees to maintain current hair care regimen, refraining from hair weaving, hair colorants or dyes and non-study hair growth products during the study.

Exclusion Criteria:

History of hair loss for reasons other than AGA
Scarring of the scalp or any condition or disease of the scalp, hair or hair shaft
Use of products within 6 months of study start used continuously for at least 1 month that could impact hair growth
Hair-weaving within 6 months
Use of hair colorants or dyes within 6 months.
Intervention: Velpatasvir
Trial phase: Phase 2
ATC code: J05AP55 | J05AP56
SMILES: COC[C@H]1C[C@@H](c2nc(-c3ccc4c(c3)COc3cc5c(ccc6nc([C@@H]7CC[C@H](C)N7C(=O)[C@@H](NC(=O)OC)C(C)C)[nH]c65)cc3-4)c[nH]2)N(C(=O)[C@H](NC(=O)OC)c2ccccc2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 101
Group description: SOF/VEL 400/100 mg FDC tablet once daily for 12 weeks
Eligibility criteria:
Key Inclusion Criteria:

Willing and able to provide written informed consent
Individuals with chronic genotype 3 HCV infection and compensated cirrhosis
Individuals with or without HIV-1 coinfection

Key Exclusion Criteria:

History of clinically significant illness or any other medical disorder that may interfere with individual's treatment assessment or compliance with the protocol
Co-infection with active hepatitis B virus
Laboratory results outside the acceptable ranges at screening
Pregnant or nursing female
Chronic liver disease not caused by HCV

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Velpatasvir
Trial phase: Phase 2
ATC code: J05AP55 | J05AP56
SMILES: COC[C@H]1C[C@@H](c2nc(-c3ccc4c(c3)COc3cc5c(ccc6nc([C@@H]7CC[C@H](C)N7C(=O)[C@@H](NC(=O)OC)C(C)C)[nH]c65)cc3-4)c[nH]2)N(C(=O)[C@H](NC(=O)OC)c2ccccc2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Eligibility criteria:
Key Inclusion Criteria:

History of chronic HCV infection (≥ 6 months)
HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate
Liver transplant ≥ 3 months prior to screening
Male and nonpregnant/ non-lactating female individuals without cirrhosis or with compensated cirrhosis

Key Exclusion Criteria:

History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol,
Co-infection with HIV or hepatitis B virus
Known hypersensitivity to study medication,
Use of any prohibited concomitant medications as within with window before the Day 1 visit.
De novo or recurrent hepatocellular carcinoma posttransplant

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Intervention: Kenalog
Trial phase: Not Applicable
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 32
Group description: Each lesion randomized to this group will receive a single intralesional treatment with 0.1mL of triamcinolone 10mg/mL solution.

Triamcinolone Acetonide 10mg/mL: Triamcinolone acetonide is a glucocorticoid used in intralesional treatment of many skin diseases, intra-articular treatment of inflammatory joint diseases, and intramuscular treatment for systemic management of systemic inflammatory diseases. It is commonly used in clinical practice for the treatment of acute abscesses and nodules of hidradenitis suppurativa, but little clinical trial data exist supporting its use.
Eligibility criteria:
Inclusion Criteria:

Male and females > or = 16 years of age
Diagnosis or history of clinical features consistent with hidradenitis suppurativa for >1 year
Patient must have an inflammatory lesion at the time of treatment. This can be an inflammatory nodule defined by a tender, palpable subcutaneous nodule, or an abscess defined as as fluctuant, painful, subcutaneous nodule. Lesions greater than 2 centimeters in size will not be excluded. Inflammatory nodules or abscesses can be treated if they are associated with a sinus tract, which is a chronic HS lesion defined by tunneled lesion with multiple openings to the surface of the skin. Sinus tracts without associated nodules or abscesses will not be treatment targets.
Patient must be off of antibiotics or on a stable course of oral antibiotics for >4 weeks prior to the baseline visit. Allowable antibiotics during treatment course are topical clindamycin, topical chlorhexidine gluconate, oral doxycycline, oral minocycline, or oral clindamycin +/- rifampin.
Must be able to provide adequate informed consent for themselves

Exclusion Criteria:

Any patient with signs of active infection at the time of screening that is not related to their hidradenitis suppurativa
Patients who have been on non-permitted antibiotics in the 4 weeks prior to baseline. Allowable antibiotics during treatment course are topical clindamycin, topical chlorhexidine gluconate, oral doxycycline, oral minocycline, or oral clindamycin +/- rifampin.
Patients who have had surgical intervention of the treated body region (i.e., right axilla) beyond incision and drainage procedures in the last 8 weeks or with open surgical wounds in the treatment region.
Patients who have been started on immunomodulatory or biologic treatment (i.e., adalimumab, infliximab) in the past 4 weeks
Patients on non-stable doses of opiate analgesics for the last 14 days prior to screening
Patients with history of hypersensitivity reactions to triamcinolone
Ongoing health or physical exam concerns which the investigator feels may put the patient at significant risk
Intervention: Kenalog
Trial phase: Not Applicable
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 32
Group description: Each lesion randomized to this group will receive a single intralesional treatment with 0.1mL of triamcinolone 40mg/mL solution.

Triamcinolone Acetonide 40mg/mL: Triamcinolone acetonide is a glucocorticoid used in intralesional treatment of many skin diseases, intra-articular treatment of inflammatory joint diseases, and intramuscular treatment for systemic management of systemic inflammatory diseases. It is commonly used in clinical practice for the treatment of acute abscesses and nodules of hidradenitis suppurativa, but little clinical trial data exist supporting its use.
Eligibility criteria:
Inclusion Criteria:

Male and females > or = 16 years of age
Diagnosis or history of clinical features consistent with hidradenitis suppurativa for >1 year
Patient must have an inflammatory lesion at the time of treatment. This can be an inflammatory nodule defined by a tender, palpable subcutaneous nodule, or an abscess defined as as fluctuant, painful, subcutaneous nodule. Lesions greater than 2 centimeters in size will not be excluded. Inflammatory nodules or abscesses can be treated if they are associated with a sinus tract, which is a chronic HS lesion defined by tunneled lesion with multiple openings to the surface of the skin. Sinus tracts without associated nodules or abscesses will not be treatment targets.
Patient must be off of antibiotics or on a stable course of oral antibiotics for >4 weeks prior to the baseline visit. Allowable antibiotics during treatment course are topical clindamycin, topical chlorhexidine gluconate, oral doxycycline, oral minocycline, or oral clindamycin +/- rifampin.
Must be able to provide adequate informed consent for themselves

Exclusion Criteria:

Any patient with signs of active infection at the time of screening that is not related to their hidradenitis suppurativa
Patients who have been on non-permitted antibiotics in the 4 weeks prior to baseline. Allowable antibiotics during treatment course are topical clindamycin, topical chlorhexidine gluconate, oral doxycycline, oral minocycline, or oral clindamycin +/- rifampin.
Patients who have had surgical intervention of the treated body region (i.e., right axilla) beyond incision and drainage procedures in the last 8 weeks or with open surgical wounds in the treatment region.
Patients who have been started on immunomodulatory or biologic treatment (i.e., adalimumab, infliximab) in the past 4 weeks
Patients on non-stable doses of opiate analgesics for the last 14 days prior to screening
Patients with history of hypersensitivity reactions to triamcinolone
Ongoing health or physical exam concerns which the investigator feels may put the patient at significant risk
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 32
Group description: Each lesion randomized to this group will receive a single intralesional treatment with 0.1mL of sterile normal saline solution.

Normal Saline: Normal saline 0.1mL will be administered intralesionally at the selected site.
Eligibility criteria:
Inclusion Criteria:

Male and females > or = 16 years of age
Diagnosis or history of clinical features consistent with hidradenitis suppurativa for >1 year
Patient must have an inflammatory lesion at the time of treatment. This can be an inflammatory nodule defined by a tender, palpable subcutaneous nodule, or an abscess defined as as fluctuant, painful, subcutaneous nodule. Lesions greater than 2 centimeters in size will not be excluded. Inflammatory nodules or abscesses can be treated if they are associated with a sinus tract, which is a chronic HS lesion defined by tunneled lesion with multiple openings to the surface of the skin. Sinus tracts without associated nodules or abscesses will not be treatment targets.
Patient must be off of antibiotics or on a stable course of oral antibiotics for >4 weeks prior to the baseline visit. Allowable antibiotics during treatment course are topical clindamycin, topical chlorhexidine gluconate, oral doxycycline, oral minocycline, or oral clindamycin +/- rifampin.
Must be able to provide adequate informed consent for themselves

Exclusion Criteria:

Any patient with signs of active infection at the time of screening that is not related to their hidradenitis suppurativa
Patients who have been on non-permitted antibiotics in the 4 weeks prior to baseline. Allowable antibiotics during treatment course are topical clindamycin, topical chlorhexidine gluconate, oral doxycycline, oral minocycline, or oral clindamycin +/- rifampin.
Patients who have had surgical intervention of the treated body region (i.e., right axilla) beyond incision and drainage procedures in the last 8 weeks or with open surgical wounds in the treatment region.
Patients who have been started on immunomodulatory or biologic treatment (i.e., adalimumab, infliximab) in the past 4 weeks
Patients on non-stable doses of opiate analgesics for the last 14 days prior to screening
Patients with history of hypersensitivity reactions to triamcinolone
Ongoing health or physical exam concerns which the investigator feels may put the patient at significant risk
Intervention: Pregabalin
Trial phase: Phase 4
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 110
Group description: Pregabalin: Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
Eligibility criteria:
Inclusion Criteria:

Requested and consented for pregnancy termination by medical abortion
Willing and able to complete multiple electronic surveys

Exclusion Criteria:

Previous participation in this trial
Current use of pregabalin or gabapentin
Contraindication to medical abortion with mifepristone and misoprostol
Contraindication or allergy to ibuprofen, oxycodone, acetaminophen, or pregabalin
Unable to understand and sign written informed consents in English
Intervention: Ferric Sulfate
Trial phase: Not Applicable
SMILES: O.O.O.O.O.O=S(=O)([O-])[O-].O=S(=O)([O-])[O-].O=S(=O)([O-])[O-].[Fe+3].[Fe+3]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 57
Group description: Subject with pulpotomy treated with FS FS paste (<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth

Ferric Sulfate: Ferric Sulfate paste
Eligibility criteria:
Inclusion Criteria:

ASA I,II
Primary Molars diagnosed with normal or reversible pulpitis with vital carious pulp exposures
Teeth that can have hemostasis can be achieved with pressure
No clinical symptoms
No radiographic signs of internal resorption or external root resorption

Exclusion Criteria:

Primary Molars diagnosed with irreversible pulpitis or necrotic pulp
Teeth that can not achieve hemostasis
Teeth with abscess or fistula
Teeth that have radiographic signs of internal resorption or external resorption
Intervention: Atomoxetine
Trial phase: Phase 2
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Double blind Placebo group

Overall subjects who received placebo capsules
Eligibility criteria:
Inclusion Criteria:

40 years old or older
Neurogenic Orthostatic Hypotension (defined by a reduction of ≥20 mmHg drop in SBP within 3 minutes of standing, associated with impaired autonomic reflexes as assessed by autonomic function tests.

Exclusion Criteria:

Pregnancy or breastfeeding
Hypersensitivity to atomoxetine (severe allergic reaction, rash, urticaria, anaphylaxis)
Use of other norepinephrine transporter inhibitors such as Wellbutrin (Bupropion), Cymbalta (Duloxetine), Effexor (venlafaxine), Pristiq (desvenlafaxine), Savella (milnacipran)
Previous history (within 14 days prior to enrollment) and current use of monoamine oxidase inhibitors
Concomitant use of strong CYP2D6 inhibitors such as delavirdine, paroxetine, fluoxetine, quinidine
Pre-existing sustained severe hypertension (BP ≥ 140/80 mmhg in the sitting position)
Impaired hepatic function (aspartate amino transaminase [AST] and/or alanine amino transaminase [ALT] >2 x upper limit of normal range)
Impaired renal function (serum creatinine equal or more than 1.6 mg/dl)
Myocardial infarction within 6 months prior to enrollment
Congestive heart failure (LV hypertrophy acceptable)
History of serious neurologic disease such as cerebral hemorrhage, or stroke
Inability to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, unlikelihood of completing the study, and mental conditions rendering the subject unable to understand the nature, scope, and possible consequences of the study
Narrow-angle glaucoma
Intervention: Ospemifene
Trial phase: Phase 4
ATC code: G03XC05
SMILES: OCCOc1ccc(/C(=C(/CCCl)c2ccccc2)c2ccccc2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: 60 mg ospemifene daily for 20 weeks

Ospemifene: FDA approved medication for the treatment of vulvovaginal atrophy and dyspareunia
Eligibility criteria:
Inclusion Criteria:

Subject provides written informed consent and HIPAA authorization before any study procedures are conducted
Subject is female
Subject is aged 21-80 years
Subject has a body mass index (BMI) < 37 kg/m2
Subject is menopausal either naturally (at least 12 months amenorrheic) or 6 weeks after a bilateral salpingo-oophorectomy prior to natural menopause subjects with hysterectomy only must have a serum Follicle Stimulating Hormone > 40 milli-International unit /mL
Subject has vulvovaginal atrophy with dyspareunia
Subject has had a normal mammogram within the last 6 months
Subject has normal pap smear within last 6 months
Subject has an endometrial stripe ≤ 4 mm within the last 6 months if she has a uterus
Subject agrees to comply with the study procedures and visits.

Exclusion Criteria:

Subject has a hypersensitivity to any of the ingredients of ospemifene
Subject has used ospemifene in the past
Subject has documented or suspected breast cancer, history of heart attack or stroke
Subject has clinically significant findings on physical examination
Subject has uncontrolled hypertension
Subject has any chronic medical condition or psychologic disorder that the Principal Investigator feels makes her ineligible for the study
Subject is currently on local or systemic androgen therapy including local or systemic testosterone (washout 14 days for local or topical androgen or non-depot injection, 1 month for depot, 6 months for pellet
Subject is currently on local or systemic estrogen therapy or androgen therapy (washout 14 days for vaginal estrogen, 60 days for oral/transdermal therapy)
Subject is currently using a Selective Estrogen Receptor Modulator (SERM) or products that have estrogenic or anti-estrogenic effects within last month
Subject currently using itraconazole, ketoconazole, digitalis or alkaloids heparin or strong cytochrome P 450 3A4 inhibitors
Subject has a history of substance abuse within 12 months prior, or consuming > 14 alcoholic drinks per week
Subject has received an investigational drug within 30 days prior to signing consent
Subject has any condition or exhibits behavior that indicates to the Principal Investigator that the Subject is unlikely to be compliant with study procedures and visits.
Intervention: Adenosine
Trial phase: Phase 2
ATC code: C01EB10 | J05AB03 | S01AD06
SMILES: Nc1ncnc2c1ncn2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: Cream

IDP-122 Vehicle Cream: Vehicle
Eligibility criteria:
Key Inclusion Criteria:

Male or female, of any race, at least 18 years of age (inclusive).
Freely provides both verbal and written informed consent.
Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
Subject is willing to comply with study instructions and return to the clinic for required visits.

Key Exclusion Criteria:

Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.
Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
Is pregnant, nursing an infant, or planning a pregnancy during the study period.
Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.