anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Dihydroergotamine
Trial phase: Phase 3
ATC code: N02CA01 | N02CA51
SMILES: [H][C@@]12Cc3c[nH]c4cccc(c34)[C@@]1([H])C[C@@H](C(=O)N[C@]1(C)O[C@]3(O)N(C1=O)[C@@H](Cc1ccccc1)C(=O)N1CCC[C@]13[H])CN2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 731
Group description: Subjects received a single oral dose of STS101 (dihydroergotamine nasal powder) 5.2 mg
Eligibility criteria:
Key Inclusion Criteria:

Males or females, 18-65 years of age at the time of Screening Visit
Subject has at least 1-year history of migraines (with or without aura), according to the International Classification of Headache Disorder, 3rd Edition (ICHD3)

Key Exclusion Criteria:

Pregnant or breast-feeding women
Women of child-bearing potential not using or not willing to use highly effective contraception.
Diagnosis of headache conditions other than migraine with or without aura, including diagnosis of basilar or hemiplegic migraines or cluster headache.
History of coronary artery disease, coronary artery vasospasm (including Printz-metals' angina), clinically significant arrhythmia or, peripheral vascular disease, ischemic disease (e.g. Raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia); percutaneous coronary intervention, or cardiac surgery.
History of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage.
Diagnosis of major depression with current symptoms, psychosis, alcohol abuse or dependence, drug abuse or dependence, major psychiatric conditions (e.g. schizophrenia, psychosis or Bipolar disorder), dementia. Other significant neurological or psychiatric disorders (including other pain syndromes or risk of suicide) that in the opinion of the investigator might interfere with study participation and assessments or subject safety.
Any clinically significant symptoms or conditions, including but not limited to central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such conditions that, in the opinion of the investigator might interfere with study assessments or safety of participant.
Intervention: Afamelanotide
Trial phase: Phase 2
ATC code: D02BB02
SMILES: CCCCC(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(C)=O)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1cnc[nH]1)C(=O)NC(Cc1ccccc1)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NCC(=O)NC(CCCCN)C(=O)N1CCCC1C(=O)NC(C(N)=O)C(C)C
Sex: Male
Age groups: Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Group A are administered afamelanotide implant on Days 0, 21 and 42;
Group B are administered afamelanotide implant on Days 0 and 28.
Eligibility criteria:
Inclusion Criteria:

Male subjects with a diagnosis of mild to moderate acne vulgaris, defined as an Investigator's global assessment (IGA) score of 2-3;
Chronic course of acne vulgaris;
Acne-related lesions both on the face, chest and back;
Indication for treatment of acne vulgaris;
Aged 18-30 years (inclusive);
Fitzpatrick skin types I-III;
Providing written Informed Consent prior to the performance of any study-specific procedure.

Exclusion Criteria:

Female subjects;
Diagnosis of severe acne vulgaris;
Allergy to afamelanotide or the polymer contained in the implant or to lidocaine or other local anesthetic to be used during the administration of the implant;
Use of topical acne medication such as retinoids, benzoyl peroxide or topical antibiotics within 2 weeks prior to the first dose;
Use of oral antibiotics for acne within 4 weeks prior to the first dose;
Use of topical corticosteroids on the face, chest and back or systemic corticosteroids within the past 4 weeks prior to the first dose;
Use of systemic retinoids within 6 months prior to the first dose;
Use of anti-androgenic agents such as finasteride within 4 weeks prior to the first dose;
Use of phototherapy devices for acne such as ClearLight™ or Zenozapper within 1 week prior to the first dose;
Use of tanning booths or lamps within 1 week prior to the first dose;
Active skin disease that may interfere with evaluation;
Other forms of acne such as acne rosacea, acne excoriée, chloracne, acne conglobata, acne fulminans, acne inversa or drug-induced acne;
Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit.
Intervention: Tranexamic acid
Trial phase: Phase 4
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 98
Group description: Each patient undergoing routine bilateral breast reduction will be randomized to receive the study drug (topical tranexamic acid) either to the right or left breast at the conclusion of the operation, prior to closure of the incisions. The other breast will receive topical saline.

Tranexamic acid: Topical tranexamic acid (1000mg) will be administered to the raw surface of the breast prior to closure of the incisions.
Eligibility criteria:
Inclusion Criteria:

Being over the age of 18
Undergoing bilateral reduction mammoplasty at the Hutchinson Metro Center of Montefiore Medical Center, Bronx, New York

Exclusion Criteria:

Oncologic breast reduction
Unilateral breast reduction
History of thromboembolic disease
History of bleeding diatheses
History of stroke
History of seizure disorder
Currently pregnant
Severe comorbidity (defined as American Society of Anesthesiologists (ASA) fitness grade IV or above)
Intervention: Afamelanotide
Trial phase: Phase 2
ATC code: D02BB02
SMILES: CCCCC(NC(=O)C(CO)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(C)=O)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1cnc[nH]1)C(=O)NC(Cc1ccccc1)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NCC(=O)NC(CCCCN)C(=O)N1CCCC1C(=O)NC(C(N)=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Six adult patients with clots located in the higher segments of the brain and who are ineligible for alternative treatments will be enrolled in the study and evaluated for six weeks. The study will assess patients' brain injury with computed tomography (CT) scans and magnetic resonance imaging (MRI), as well as using recognised methods of clinical evaluation to measure changes in patients' neurological and cognitive function following treatment.
Eligibility criteria:
Inclusion Criteria:

Male or female subjects with a diagnosis of first AIS due to distal [M2 segment and beyond] occlusion or perforator occlusion
Perfusion abnormalities observed on Computed Tomography Perfusion (CTP)
Mild to moderate stroke severity
Pre-stroke mRS <4
Written informed consent obtained from patient and/or medical treatment decision maker prior to study-start (upon admission).

Exclusion Criteria:

Administration of intravenous thrombolytic therapy in distal occlusion as etiology of AIS
Intervention by endovascular thrombectomy (EVT)
Known allergy or anaphylaxis to adrenocorticotropic hormone (ACTH) or melanocortins or any of the excipients listed in the Investigator's Brochure
Any evidence of hepatic (defined as three times standard range) or renal impairment (defined as estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m²)
Any other medical condition which may interfere with the study protocol
Female who is pregnant (confirmed by positive serum beta human chorionic gonadotropin (β-HCG) pregnancy test prior to baseline) or lactating
Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device) or a lifestyle excluding pregnancy
Unable to undergo MRI brain evaluation
Not suitable for trial participation according to judgment of the Principal Investigator (PI)
Patients starting afamelanotide 24 hours or more from ictus.
Intervention: Amoxicillin
Trial phase: Early Phase 1
ATC code: A02BD01 | A02BD03 | A02BD04 | A02BD05 | A02BD06 | A02BD07 | A02BD10 | A02BD11 | A02BD12 | A02BD13 | A02BD14 | A02BD15 | A02BD16 | J01CA04 | J01CR50
SMILES: [H][C@]12SC(C)(C)[C@H](C(=O)O)N1C(=O)[C@H]2NC(=O)[C@H](N)c1ccc(O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 5
Group description: Randomization to receive either oral amoxicillin or placebo for a standard course (10 days)

Amoxicillin: Participants will be randomized to receive oral amoxicillin for a standard course (10 days)
Eligibility criteria:
Inclusion Criteria:

Age 12-71 months; and

Diagnosis of CAP, defined using established criteria:

Signs and symptoms of lower respiratory tract infection (LRTI), defined as one or more of the following:

new or different cough; or
new or different sputum production; or
chest pain; or
dyspnea/shortness of breath; or
documented tachypnea; or
abnormal findings consistent with LRTI on physical examination (e.g., crackles/rales, rhonchi, wheezing) and
Fever, defined as temperature greater than or equal to 38 degrees C, and
ED clinician diagnosis of CAP, including intention to treat with antibiotics, and
Chest radiography suspicious for CAP
Treatment as an outpatient after ED visit.
Procalcitonin < 0.25 ng/mL

Exclusion Criteria:

Hospitalization within 7 days preceding study visit; or
Sustained oxygen saturations <90% with appropriate waveform on oximeter; or
Incomplete immunization status (<3 doses of Hib and pneumococcal vaccines; or
Chronic complex medical conditions (chronic heart disease, chronic lung disease (not including asthma), congenital airway or lung malformations, cystic fibrosis, chronic renal disease, protein-losing enteropathy, genetic syndromes, neurocognitive deficits, or metabolic disorders); or
Conditions that compromise the immune system (HIV, primary immunodeciency, asplenia, sickle cell disease, receipt of hematopoietic stem cell or solid organ trans- plant, immunosuppressive agents, daily corticosteroids for more than 7 consecutive days in past 14 days) ; or
Systemic antibiotic receipt within the previous 7 days of CAP diagnosis; or
Radiographic findings of complicated pneumonia (moderate-to-large pleural effusion, empyema, abscess, necrotic lung disease) ; or
Pneumonia known to be due to bacterial source at the time of enrollment, as documented by blood culture or PCR if available, or another clear source of bacterial infection requiring immediate antibiotics; or
Toxic clinical appearance, sepsis, or critical illness as determined by clinical team at ED presentation; or
Diagnosed with pneumonia in previous 6 months; or
Provider diagnosis of bronchiolitis, bronchitis, or aspiration pneumonia; or
Concomitant asthma exacerbation requiring systemic corticosteroids; or
Severe drug allergy to amoxicillin; or
Any other condition that in the judgement of investigators or the clinical team could affect safety of the subject; or
No access to a telephone or video technology for follow-up; or
Current enrollment in another clinical trial of an investigational agent; or
Previous enrollment in this trial.
Intervention: Roflumilast
Trial phase: Phase 3
ATC code: R03DX07
SMILES: O=C(Nc1c(Cl)cncc1Cl)c1ccc(OC(F)F)c(OCC2CC2)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 304
Group description: Participants with seborrheic dermatitis applied roflumilast foam 0.3% once daily (QD) for 8 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
Males and females ages 9 years and older at the time of consent.
Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks.
Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas.
An Investigator Global Assessment (IGA) disease severity of at least Moderate ('3') at Baseline.
Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate ('2') at Baseline.
Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2).
Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
Subjects in good health as judged by the Investigator.
Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.

Key Exclusion Criteria:

Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study.
Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
Previous treatment with ARQ-154 or ARQ-151.
Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
Subjects, parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s).
Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members living in the same house of enrolled subjects.
Intervention: Rilematovir
Trial phase: Phase 2
SMILES: CS(=O)(=O)CCCn1c(Cn2c(=O)n(CC(F)(F)F)c3ccncc32)cc2cc(Cl)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Participants received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days.
Eligibility criteria:
Inclusion Criteria:

Presented to the healthcare facility with symptoms suggestive of a diagnosis of acute respiratory syncytial virus (RSV) infection
Has at least 2 symptoms of lower respiratory tract disease (LRTD), one of which must be scored as at least 'moderate' if the symptoms did not pre-exist before RSV onset, or one of which is scored worse than usual if the symptoms pre-existed
Tested positive for RSV infection using a molecular-based diagnostic assay (polymerase chain reaction [PCR] or other) on a bilateral nasal mid-turbinate swab sample
Has at least one of the following high-risk conditions that predispose them to RSV-related disease progression: a. age greater than or equal to (>=) 65 years, b. congestive heart failure (CHF), c. chronic obstructive pulmonary disease (COPD), d. asthma
Randomized to study intervention treatment within 72 hours after onset of any of the RSV symptoms or worsening of pre-existing symptoms
Not be hospitalized during screening (emergency room or hospital observation status for an anticipated duration of less than [<] 24 hours are not considered as hospitalization)

Exclusion Criteria:

Known allergies, hypersensitivity, or intolerance to rilematovir or to any of the excipients of rilematovir or placebo formulation
Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial arrhythmia, or sustained ventricular arrhythmia
Participant has known or suspected (from medical history or participant examination) chronic or acute hepatitis B or C infection
Immunocompromised conditions
Living in institutional care or assisted living facility and also receiving acute care management for any respiratory condition
Intervention: Cannabidiol
Trial phase: Phase 2
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: All subjects will receive 600mg of oral cannabidiol in a double-blind fashion. Cannabidiol will be provided using Epidiolex™ oral solution 100mg/mL. Following administration, a battery of tests will be conducted to examine reward- and stress-related neurocognitive processes.

Cannabidiol 100 MG/ML [Epidiolex]: 600mg

This arm represents the visits all participants received CBD.
Eligibility criteria:
Inclusion Criteria

English speaking
DSM5 diagnosis of opioid use disorder
Receiving buprenorphine or methadone for treatment of opioid use disorder
Agreeable to abstaining from using any cannabis or CBD products for the duration of the trial.

Exclusion Criteria:

Any self-reported use of cannabis or CBD products in the past 30 days
Baseline depression (PHQ9) or anxiety (GAD7) scores of greater than 10
Currently pregnant
Hepatic liver enzymes greater than 3x upper normal limit
Hypersensitivity to cannabinoids or sesame oil (CBD solution comes in sesame oil emulsion)
Currently taking any medications with known significant pharmacokinetic interactions with CBD
Intervention: Furosemide
Trial phase: Not Applicable
ATC code: C03CA01 | C03CB01 | C03EB01 | G01AE10
SMILES: NS(=O)(=O)c1cc(C(=O)O)c(NCc2ccco2)cc1Cl
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: volunteers received Furosemide 40 mg tablet with 240 mL of water

Furosemide 40 mg: Administered with 240 mL of water
Eligibility criteria:
Inclusion Criteria:

have read the subject information and signed informed consent documents
age 18 - 55 years
body mass index between 18-25 kg/m2
have a normal electrocardiogram
blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg)
heart rate within normal range (60-100 bpm)
with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening
acceptance to use protection (condom) during intercourse with their spouse throughout the study

Exclusion Criteria:

those who are pregnant and/or nursing women
those with a history of hypersensitivity to furosemide, or other diuretics or other ingredients in the drugs or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction
those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease.
those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities
those who are using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day
those who have participated in any clinical study within 3 months prior to the study (< 90 days)
those who have donated or lost 300 ml (or more) of blood within 3 months prior to the study
those who smoke more than 10 cigarettes a day
those who are positive to HIV, HBsAg, and HCV tests (to be kept confidential)
those with a history of drug or alcohol abuse within 12 months prior to screening for this study
those who are unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access
Intervention: Furosemide
Trial phase: Not Applicable
ATC code: C03CA01 | C03CB01 | C03EB01 | G01AE10
SMILES: NS(=O)(=O)c1cc(C(=O)O)c(NCc2ccco2)cc1Cl
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: volunteers received Lasix® 40 mg tablet with 240 mL of water

Lasix® 40 mg Tablet: Administered with 240 mL of water
Eligibility criteria:
Inclusion Criteria:

have read the subject information and signed informed consent documents
age 18 - 55 years
body mass index between 18-25 kg/m2
have a normal electrocardiogram
blood pressure within normal range (systolic 90-120 mmHg and diastolic 60-80 mmHg)
heart rate within normal range (60-100 bpm)
with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening
acceptance to use protection (condom) during intercourse with their spouse throughout the study

Exclusion Criteria:

those who are pregnant and/or nursing women
those with a history of hypersensitivity to furosemide, or other diuretics or other ingredients in the drugs or a history of serious allergic reaction to any drug, a significant allergic disease, or allergic reaction
those with a history or presence of medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease.
those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities
those who are using any medication (prescription or non-prescription drug, food supplement, herbal medicine), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day
those who have participated in any clinical study within 3 months prior to the study (< 90 days)
those who have donated or lost 300 ml (or more) of blood within 3 months prior to the study
those who smoke more than 10 cigarettes a day
those who are positive to HIV, HBsAg, and HCV tests (to be kept confidential)
those with a history of drug or alcohol abuse within 12 months prior to screening for this study
those who are unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access
Intervention: Pilocarpine Hydrochloride
Trial phase: Phase 3
SMILES: CCC1C(=O)OCC1Cc1cncn1C.Cl
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 114
Group description: AGN-190584 ophthalmic solution, one drop bilaterally (in each eye), BID, with a gap of 6 hours between both doses, for up to 14 days.
Eligibility criteria:
Inclusion Criteria:

- Objective and subjective evidence of presbyopia.

Exclusion Criteria:

Corneal abnormalities (including keratoconus, corneal scar, Fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity.
Narrow iridocorneal angles (Shaffer grade <=2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy.
Diagnosis of any type of glaucoma or ocular hypertension.
History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery.
Use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes.