anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Poseltinib
Trial phase: Phase 1
SMILES: C=CC(=O)Nc1cccc(Oc2nc(Nc3ccc(N4CCN(C)CC4)cc3)nc3ccoc23)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: A single, PO dose of 20 mg LY3337641 (T2)with water after an overnight fast in one of four periods
Eligibility criteria:
Inclusion Criteria:

Are overtly healthy males or females, as determined by medical history and physical examination
Have a body mass index (BMI) of 18.5 to 32 kilograms per meter squared (kg/m²) inclusive
Have clinical laboratory test results within normal reference range for the population or investigative site
Are able and willing to give signed informed consent

Exclusion Criteria:

Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
Have significant history of or current cardiovascular, dermatological (such as eczema, psoriasis, and acne), respiratory, hepatic, renal, gastrointestinal (cholecystectomy is not acceptable), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
Have used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to planned dosing
In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
Intervention: Bakuchiol
Trial phase: Early Phase 1
SMILES: C=C[C@@](C)(/C=C/c1ccc(O)cc1)CCC=C(C)C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 44
Group description: Bakuchiol 0.5% applied to face twice daily

Bakuchiol: This group will receive bakuchiol
Eligibility criteria:
Inclusion Criteria:

• Individuals aged 30-55

Exclusion Criteria:

Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant or breast feeding women
Prisoners
Those with acne, eczema, seborrheic dermatitis, rosacea or polycystic ovarian syndrome
Those who have used isotretinoin in the last 6 months
Those who have used products containing salicylic acid, beta hydroxyl acids or vitamins A, C, or E in the last 14 days
Those who have used topical antibiotics or topical retinoids in the last 30 days
Those who are currently smoking or have smoked within the past 3 years.
Those who have had a recent surgical or cosmetic procedure in the last 3 months that can affect facial wrinkles or facial hyperpigmentation, such as botulinum toxin injections, chemical peels, laser based therapies to the face, or face lift surgeries
Intervention: Pimavanserin
Trial phase: Phase 2
ATC code: N05AX17
SMILES: CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 78
Group description: All patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 2 visit, the dose could be increased to 34 mg QD based on the investigator's assessment of clinical response. Subsequently, the dose could be adjusted from 34 mg to 20 mg or from 20 mg to 34 mg at any visit based on clinical response.
Eligibility criteria:
Inclusion Criteria:

Must complete the Week 12 visit in Study ACP-103-032 while continuing to take his/her assigned dose of blinded study drug

Can understand the nature of the trial and protocol requirements and provide signed informed consent

from patient, if deemed competent to provide consent
from an appropriate person (e.g. patient's Legally Authorized Representative (LAR) with the patient's assent) if patient is deemed not competent to provide informed consent.
Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient)
Has a designated study partner/caregiver who is in contact with the patient at least 3 times a week on 3 separate days
Female patients must be of non-childbearing potential or must agree to use an acceptable method of contraception or abstinence, during the study, and 1 month following completion of the study
The patient and caregiver are willing and able to participate in all schedule evaluations and complete all required tests

Exclusion Criteria:

Patient was significantly non-compliant in Study ACP-103-032
The Investigator becomes aware of an impending and unexpected change in the patient's living situation (e.g., change in caregiver, change in facility, moving from home to facility, moving from one family member or caregiver's home to another) that may cause a major disruption in the patient's behavior
Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
Patient is bedridden or has any significant medical condition that is unstable and would place the patient at undue risk from study drug or study procedures
Has clinically significant laboratory abnormalities that would jeopardize the safe participation of the patient in the study
Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on Investigator's assessment of behavior since the last assessment
Intervention: Natrii lactatis solutio composita
Trial phase: Phase 4
SMILES: CC(O)C(=O)[O-].O.[Ca+2].[Cl-].[Cl-].[K+].[Na+].[Na+].[OH-].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 157
Group description: Participants in this arm will receive two liters of IV Lactated Ringer's solution during their emergency department stay

Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV
Eligibility criteria:
Inclusion Criteria:

Emergency department patient
Chief complaint of nausea, vomiting or emesis, diarrhea, abdominal pain, dehydration, heat stroke or exhaustion
ED provider approves administration of two liters of fluid
ED provider states patient is likely to be discharged
Patient has followed up with PCP in the last two years
Patient has access to phone for next two days following ED discharge

Exclusion Criteria:

Prisoners
Children
Women known to be pregnant
Jaundice
Current chemotherapy
Intervention: Misoprostol
Trial phase: Phase 4
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 36
Group description: Intervention is misoprostol versus placebo 400mcg misoprostol formulated within cocoa butter suppository

Vaginal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D&E
Eligibility criteria:
Inclusion Criteria:

The study will enroll healthy English or Spanish-speaking women, over 18 years of age, eligible for non-urgent D&E at 16 0/7 weeks to 20 6/7 weeks gestation, confirmed by sonogram, and willing/able to undergo informed consent.

Exclusion Criteria:

Emergent need for D&E, intrauterine infection, fetal demise, molar pregnancy, intolerance, allergy or contraindication to mifepristone or misoprostol
Intervention: Misoprostol
Trial phase: Phase 4
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 34
Group description: Intervention is misoprostol versus placebo 400mcg misoprostol formulated within mint flavored powder

Buccal Misoprostol: Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D&E
Eligibility criteria:
Inclusion Criteria:

The study will enroll healthy English or Spanish-speaking women, over 18 years of age, eligible for non-urgent D&E at 16 0/7 weeks to 20 6/7 weeks gestation, confirmed by sonogram, and willing/able to undergo informed consent.

Exclusion Criteria:

Emergent need for D&E, intrauterine infection, fetal demise, molar pregnancy, intolerance, allergy or contraindication to mifepristone or misoprostol
Intervention: Sildenafil
Trial phase: Phase 3
ATC code: G01AE10 | G04BE03
SMILES: CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Subjects randomized to this arm will receive sildenafil 5 mg 3 times per day for the first week, and titrated to 10 mg 3 times per day for the second week, and 20 mg 3 times per day from the third week to the end of the study period, 12 months.

Sildenafil: Sildenafil will be initiated at 5 mg 3 times per day for the first week, and titrated to 10 mg 3 times per day for the second week and 20 mg 3 times per day from the third week to the end of the study period, 12 months.
Eligibility criteria:
Inclusion criteria:

All adult Fontan patients who have no contraindications for magnetic resonance imaging (MRI) will be eligible for the study.

Exclusion criteria:

Subjects with implantable pacemakers
Residual cardiac lesions (severe ventricular dysfunction, severe atrioventricular valve regurgitation, Fontan baffle or conduit obstruction)
Viral hepatitis
Severe renal dysfunction
History of sildenafil use in the six months prior to study enrollment
Ongoing sildenafil therapy
Patients currently taking nitrates
Hypotension at baseline (BP <90/50 mmHg)
Pulmonary veno-occlusive disease
Hearing/vision impairment
Pulmonary hypertension due to sickle cell disease
Women of child-bearing potential with a positive pregnancy test will additionally be excluded
Intervention: OLORINAB
Trial phase: Phase 2
SMILES: CC(C)(C)[C@@H](CO)NC(=O)c1nn(-c2c[n+]([O-])ccn2)c2c1C[C@@H]1C[C@H]21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Participants received olorinab 25 milligrams (mg) oral tablets three times daily (TID) for 8 weeks
Eligibility criteria:
Key Inclusion Criteria:

A clinical diagnosis of Crohn's disease for at least 3 months prior to screening corroborated by prior endoscopic and histopathologic documentation consistent with Crohn's disease.
Quiescent to mildly active inflammatory Crohn's disease defined with a total of simple endoscopy score for Crohn's disease (SES-CD) score of < 10 or fecal calprotectin < 500 mcg/g within 4 weeks before Screening.
Moderate to severe abdominal pain as defined by average abdominal pain score (AAPS) of >/= 4points on 7 consecutive days of the screening period up to Day -2. AAPS will be based on the 11-point numeric rating scale where 0 (no abdominal pain) to 10 (worst possible abdominal pain).

Key Exclusion Criteria:

Female participants who are lactating or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 prior to study drug administration.
Recent history (within 6 months of screening visit) of cerebrovascular disease, Acute Coronary Syndrome, Cerebrovascular accident, Transient ischemic attack, Myocardial infarction, unstable angina.
Other significant chronic pain conditions that in the opinion of the Investigator may influence the abdominal pain score.
History of extensive colonic resection, subtotal or total colectomy.
History of >3 small bowel resections or diagnosis of short bowel syndrome or who have undergone bowel resection within 6 months prior to randomization.
Chronic active hepatitis B within the last year (unless shown at the time of study entry to be hepatitis B antigen negative) or any history of hepatitis C.
Evidence of current gastro-intestinal infection (bacterial or parasitic) or significant infection within 45 days of screening.

Note: other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Diclofenac sodium
Trial phase: Phase 3
SMILES: O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 398
Group description: Diclofenac Sodium Gel, 1%

Diclofenac sodium gel 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Osteoarthritis knee as per American College of Rheumatology (ACR) criteria
Evidence of OA with Kellgren-Lawrence grade 1-3 disease.
After discontinuing all pain medications, had at least moderate pain on movement (POM) for target knee
After discontinuing all pain medications for at least 7 days has a baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Likert (version 3.1)) pain subscale of ≥ 9 immediately prior to randomization.
Able to tolerate rescue medication with acetaminophen
Subjects who can read and understand WOMAC pain sub scale

Exclusion Criteria:

Pregnancy, lactation
OA of Kellgren-Lawrence grade 4
OA pain in the contralateral knee requiring medication (OTC or prescription)
History of OA of either Hip or Hands
History of secondary OA (e.g. congenital, traumatic, gouty arthritis), rheumatoid arthritis
History of chronic inflammatory disease (e.g., colitis) or fibromyalgia
History of Drugs or Alcohol abuse within the previous year
Symptomatic peripheral vascular disease of the study leg
Any musculoskeletal condition
Skin disease at the application site
Active asthma requiring periodic treatment with systemic steroids
Known history of positive HIV, hepatitis C virus, or HBsAg
Uncontrolled hypertension
History of myocardial infarction, thrombotic events, stroke etc.
Allergy to aspirin, nonsteroidal anti-inflammatory drugs (NSAID) or acetaminophen (paracetamol).
Intervention: Diclofenac sodium
Trial phase: Phase 3
SMILES: O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 405
Group description: Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%

Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%: Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Osteoarthritis knee as per American College of Rheumatology (ACR) criteria
Evidence of OA with Kellgren-Lawrence grade 1-3 disease.
After discontinuing all pain medications, had at least moderate pain on movement (POM) for target knee
After discontinuing all pain medications for at least 7 days has a baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC Likert (version 3.1)) pain subscale of ≥ 9 immediately prior to randomization.
Able to tolerate rescue medication with acetaminophen
Subjects who can read and understand WOMAC pain sub scale

Exclusion Criteria:

Pregnancy, lactation
OA of Kellgren-Lawrence grade 4
OA pain in the contralateral knee requiring medication (OTC or prescription)
History of OA of either Hip or Hands
History of secondary OA (e.g. congenital, traumatic, gouty arthritis), rheumatoid arthritis
History of chronic inflammatory disease (e.g., colitis) or fibromyalgia
History of Drugs or Alcohol abuse within the previous year
Symptomatic peripheral vascular disease of the study leg
Any musculoskeletal condition
Skin disease at the application site
Active asthma requiring periodic treatment with systemic steroids
Known history of positive HIV, hepatitis C virus, or HBsAg
Uncontrolled hypertension
History of myocardial infarction, thrombotic events, stroke etc.
Allergy to aspirin, nonsteroidal anti-inflammatory drugs (NSAID) or acetaminophen (paracetamol).
Intervention: Paclitaxel
Trial phase: Phase 2
ATC code: L01CD01 | L01CD51
SMILES: CC(=O)OC1C(=O)C2(C)C(O)CC3OCC3(OC(C)=O)C2C(OC(=O)c2ccccc2)C2(O)CC(OC(=O)C(O)C(NC(=O)c3ccccc3)c3ccccc3)C(C)=C1C2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated

NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
Eligibility criteria:
Inclusion Criteria:

Signed informed consent;
Patients over the age of 18;
Recently confirmed mucinous cystic pancreatic neoplasm; may be confirmed by presence of mucin, cyst fluid carcinoembryonic antigen (CEA) above 192 U/L, or other reliable diagnostic means such as endomicroscopy; KRAS analysis may also be performed at the discretion of the Investigator;
Unilocular cyst with diameter of at least 1.5 cm but no more than 4 cm;
Normal hematologic, hepatic, and renal function at study entry;

Appropriate steps taken to minimize or avoid the potential for pregnancy for subjects of child-bearing potential.*

Note: A female patient is considered to be of childbearing potential unless she has had a hysterectomy, is at least one year postmenopausal or has undergone tubal ligation. For the purposes of this study, adequate birth control includes at least one medically approved and highly effective method of birth control, defined as those which result in a low failure rate (i.e., < 1% per year) when used consistently and correctly, such as implants, injectables and oral contraceptives combined with the use of condoms. Only male patients whose vasectomy has been confirmed by semen analysis at least 3 months after the vasectomy are allowed not to use acceptable contraceptive methods.

Exclusion Criteria:

Positive cytology indicating malignancy;
Thrombotic or embolic events;
Known hypersensitivity to study agent;
Known drug or alcohol abuse;
Pregnant or breastfeeding women.
Intervention: Oxymetazoline
Trial phase: Phase 4
ATC code: D11AX27 | R01AA05 | R01AB07 | S01GA04
SMILES: Cc1cc(C(C)(C)C)c(O)c(C)c1CC1=NCCN1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Pledgets will be soaked in 0.05% oxymetazoline solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.

Oxymetazoline: Pledgets will be soaked in 0.05% oxymetazoline solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.
Eligibility criteria:
Inclusion Criteria:

The inclusion criteria will be patients undergoing bilateral endoscopic sinus surgery (ESS) in which the same sinuses and procedures on both sides are the same for CRS with or without nasal polyposis.

Exclusion Criteria:

pregnancy
known coagulopathy
an international normalized ratio greater than 1.3
a partial thromboplastin time greater than 50 seconds
use of non-steroidal anti-inflammatory drugs in the last 10 days (2 or more doses)
use of any antiplatelet agents (eg, warfarin, clopidogrel, berlinta)
poorly controlled hypertension with a preoperative systolic blood pressure of 160mm Hg or greater or a diastolic blood pressure of 90mm Hg or greater
having any adverse reaction to topical epinephrine or oxymetazoline.
Intervention: IVERMECTIN
Trial phase: Phase 2
ATC code: D11AX22 | P02CF01
SMILES: [H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])(C(C)C)O1)C2.[H][C@@]12C[C@@]([H])(C/C=C(\C)[C@@H](O[C@H]3C[C@H](OC)[C@@H](O[C@H]4C[C@H](OC)[C@@H](O)[C@H](C)O4)[C@H](C)O3)[C@@H](C)/C=C/C=C3\CO[C@]4([H])[C@H](O)C(C)=C[C@@]([H])(C(=O)O1)[C@]34O)O[C@@]1(CC[C@H](C)[C@@]([H])([C@@H](C)CC)O1)C2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Participants applied CD5024 0.3% cream topically in the evening to the affected areas as a thin film corresponding to approximately 2 mg/cm^2 once daily for 6 weeks.
Eligibility criteria:
Inclusion Criteria:

The participant was a male or female aged 18 to 60 years old inclusive at Screening.
The participant presented with a total body surface area (tBSA) less than or equal to (>=) 2 square meter (m^2) at Screening.
The participant had atopic dermatitis for at least 6 months prior to Day 1. The clinical diagnosis of atopic dermatitis must be confirmed with the criteria of Hanifin and Rajka at the screening visit.
Atopic dermatitis must be stable for at least one month before the screening visit (according to participant).
The participant had a Body Surface Area (BSA) affected by AD ranging from 1% inclusive to 10% inclusive at Day 1, excluding scalp and genitals.
The participant had an overall Investigator's Global Assessment (IGA) score of 3 (moderate) at Day 1;

Exclusion Criteria:

The participant was a pregnant female, is breastfeeding or intends to conceive a child during the study,
The participant had any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results (e.g. extensive scaring or pigmented lesion in a treated area), and/or put the participant at significant risk according to Investigator's judgment if he/she participates in the clinical trial (e.g. active cancer, AIDS, insulin-dependent diabetes…) at Screening or Day 1.
The participant presented with an acute flare of AD at Day 1.
The participant had active cutaneous bacterial or viral infection in any treated area at baseline (e.g. clinically infected AD) at Screening or Day 1.
The participant had a history of confounding skin condition (e.g. psoriasis, erythroderma) or a history of Netherton syndrome at Screening.
The participant had a past history of serious persistent neurological disorders such as seizures, multiple sclerosis, or neurological signs or symptoms at Screening.
Intervention: Thiamine
Trial phase: Phase 2
ATC code: A11DA01
SMILES: Cc1ncc(C[n+]2csc(CCO)c2C)c(N)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: Thiamine 200 mg IV

Thiamine: 200 mg IV three times daily for seven days
Eligibility criteria:
Inclusion Criteria:

Admission to the UNC Hospital Bone Marrow Transplant Unit for allogeneic stem cell transplant
At least 18 years of age
Able to speak English
Able to provide informed consent

Exclusion Criteria:

A history of adverse reaction to IV thiamine
Pregnancy, confirmed by a negative pregnancy test within 30 days of study enrollment
Intervention: Hydroxychloroquine
Trial phase: Phase 1 | Phase 2
ATC code: P01BA02
SMILES: CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Hydroxychloroquine 200mg BID for 6 months

Hydroxychloroquine: Treatment of patients with hidradenitis suppurativa with hydroxychloroquine 200mg BID for 6 months
Eligibility criteria:
Inclusion Criteria:

Patients with hidradenitis suppurativa Hurley stage I or II

Exclusion Criteria:

Current systemic immunosuppression, current use of biologic medication or use of these medications in the prior 3 months, patients with known retinal disease, hepatic disease (HCV, cirrhosis, aspartate aminotransferase or alanine aminotransferase > 2 times the upper limit of normal), psoriasis, porphyria cutanea tarda, platelets < 50,000/ul, leukocytes <4000/ul, or Hb<8g/dl), pregnant patients or women trying to conceive