anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Isavuconazole
Trial phase: Phase 2
ATC code: J02AC05
SMILES: C[C@@H](c1nc(-c2ccc(C#N)cc2)cs1)[C@](O)(Cn1cncn1)c1cc(F)ccc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 95
Group description: Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose. The minimum duration of prophylaxis with isavuconazole will be through D +60. Beyond day +60 discontinuation is at the discretion of the treating physician.

Isavuconazole: Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose.
Eligibility criteria:
Inclusion Criteria:

Subjects of greater than or equal to 18 years of age of either sex and of any race.
Have received first peripheral blood, marrow or cord blood transplant from a family or unrelated donor for hematologic malignancy or myeloproliferative disorder.

Exclusion Criteria:

Proven or probable aspergillosis or other mold infection or deep mycoses including hepatosplenic candidiasis less than 60 days from first dose of ISA.
History of allergy or intolerance to ISA.
Clinically significant elevation of liver function tests prior to the first day of dosing (FDD) that at the discretion of the treating physician would preclude the administration of an azole antifungal.
Familial short QT syndrome.
Intervention: Nintedanib
Trial phase: Phase 3
ATC code: L01EX09
SMILES: COC(=O)c1ccc2c(c1)NC(=O)/C2=C(\Nc1ccc(N(C)C(=O)CN2CCN(C)CC2)cc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 350
Group description: SB11 (Proposed ranibizumab biosimilar): SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
Eligibility criteria:
Inclusion Criteria:

Age ≥ 50 years
Newly diagnosed, active subfoveal choroid neovascularisation (CNV) lesion secondary to AMD in the study eye
BCVA of 20/40 to 20/200 in the study eye
Written informed consent form

Exclusion Criteria:

Any previous ITV anti-vascular endothelial growth factor (anti-VEGF) treatment to treat neovascular AMD in either eye
Presence of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia
Any concurrent macular abnormality other than AMD in the study eye
Intervention: Melatonin
Trial phase: Phase 2
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 14
Group description: Melatonin 3mg

Melatonin: Melatonin
Eligibility criteria:
Inclusion Criteria:

Age 10-17-inclusive
Weight ≥40 kg, so as not to require mg/kg based dosing
Meets International Classification of Headache Disorders III beta1 criteria for migraine in children/adolescents (international standard diagnostic criteria for research)
Lives in the state of California- to allow shipping of study medication from our pharmacy
Has at least one parent who speaks English-in order to ensure good communication with study team by phone
Has daily access to a smartphone in order to provide daily headache diary data
A Parent/Guardian consents and the adolescent is cognitively capable of giving assent to participate
Either not on a migraine preventive medication, or if on one the dose has been stable for at least 4 weeks prior to enrollment, or are willing to wait to start the study until they have reached a stable dose for 4 weeks
Willing to not use OTC melatonin or change migraine preventives during the trial
Has ≥1 headache day per week, or 4-28 days of headache in a 28-day period Episodic headaches have been present for a minimum of 6 months-This lowers the likelihood of a secondary cause of headaches

Exclusion Criteria:

Continuous headache
History of seizures/epilepsy
Pregnant/lactating
Concomitant opioid or barbiturate overuse, wherein overuse is defined as ≥4 days per month of barbiturate containing compounds, ≥10 days per month of opioid containing compounds as these may impact sleepiness scales
If in the investigator's opinion there is a medical or psychiatric concern that makes them think the participant should not participate
Inability to swallow pills after teaching and practice History of nocturnal asthma, as evidenced by a having a diagnosis of asthma and symptoms that manifest as nighttime awakening due to cough, wheeze, and/or shortness of breath

Randomization Criteria:

Had 4-28 migraine/migrainous days in the 28-day period of weeks 5-8 of single-blind placebo treatment phase, but not continuous headache.
At least 80% compliance with headache diary (i.e. at least 23 headache diary days) during weeks 5-8 of single-blind placebo treatment phase.
Intervention: Melatonin
Trial phase: Phase 2
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 14
Group description: Melatonin 6mg

Melatonin: Melatonin
Eligibility criteria:
Inclusion Criteria:

Age 10-17-inclusive
Weight ≥40 kg, so as not to require mg/kg based dosing
Meets International Classification of Headache Disorders III beta1 criteria for migraine in children/adolescents (international standard diagnostic criteria for research)
Lives in the state of California- to allow shipping of study medication from our pharmacy
Has at least one parent who speaks English-in order to ensure good communication with study team by phone
Has daily access to a smartphone in order to provide daily headache diary data
A Parent/Guardian consents and the adolescent is cognitively capable of giving assent to participate
Either not on a migraine preventive medication, or if on one the dose has been stable for at least 4 weeks prior to enrollment, or are willing to wait to start the study until they have reached a stable dose for 4 weeks
Willing to not use OTC melatonin or change migraine preventives during the trial
Has ≥1 headache day per week, or 4-28 days of headache in a 28-day period Episodic headaches have been present for a minimum of 6 months-This lowers the likelihood of a secondary cause of headaches

Exclusion Criteria:

Continuous headache
History of seizures/epilepsy
Pregnant/lactating
Concomitant opioid or barbiturate overuse, wherein overuse is defined as ≥4 days per month of barbiturate containing compounds, ≥10 days per month of opioid containing compounds as these may impact sleepiness scales
If in the investigator's opinion there is a medical or psychiatric concern that makes them think the participant should not participate
Inability to swallow pills after teaching and practice History of nocturnal asthma, as evidenced by a having a diagnosis of asthma and symptoms that manifest as nighttime awakening due to cough, wheeze, and/or shortness of breath

Randomization Criteria:

Had 4-28 migraine/migrainous days in the 28-day period of weeks 5-8 of single-blind placebo treatment phase, but not continuous headache.
At least 80% compliance with headache diary (i.e. at least 23 headache diary days) during weeks 5-8 of single-blind placebo treatment phase.
Intervention: Nicotinamide riboside
Trial phase: Phase 4
SMILES: NC(=O)c1ccc[n+]([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: Participants will receive NR at a dose of 2g/day

Nicotinamide Riboside: Nicotinamide riboside 2g/day for a 2 week duration
Eligibility criteria:
Inclusion Criteria:

Age: 18-80 year-old
Male or female
Without psychiatric diagnosis according to a structured psychiatric interview (Structured Clinical Interview for DSM-V Axis I Disorders (SCID))
Without history of a psychotic disorder and/or mood disorder among parents, siblings, or children, as obtained via self-report only.

Exclusion Criteria:

Significant medical or neurological illness.
Diagnosis diabetes mellitus (DM), uncontrolled hypertension (HTN), severe hypotension, coronary artery disease (CAD), metabolic syndrome, glaucoma, liver impairment, decreased renal function, respiratory disorders, uncontrolled peptic ulcer disease.
Taking any other medications, including over the counter supplements with the exception of oral contraceptives for women
Pregnancy. Females of child-bearing age must be using an effective contraceptive method.
History of smoking, substance abuse or dependence.
Contraindication to MR scan (claustrophobia, cardiac pacemakers, metal clips and stents on blood vessels, artificial heart valves, artificial arms, hands, legs, etc., brain stimulator devices, implanted drug pumps, ear implants, eye implants or known metal fragments in eyes, exposure to shrapnel or metal filings, other metallic surgical hardware in vital areas, certain tattoos with metallic ink, certain transdermal patches, metal- containing intrauterine devices)
Medical condition that would prevent blood draws, including current anti-coagulant or anti-aggregant therapy, tendency for abnormal scarring (e.g. keloids).
Difficulty in swallowing capsules.
Intervention: Tacrolimus
Trial phase: Phase 2
ATC code: D11AH01 | L04AD02
SMILES: C=CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(O)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Protopic® 0.1% ointment, packed in blinded tube of 30g.

Protopic® (Tacrolimus) 0.1% ointment: About 0,1g of ointment is administered by the patient on nasal mucosa of each nostril twice a day for 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years.
Patients who have given their free, informed and signed consent.
Patients affiliated to a social security scheme or similar.
Patients monitored for clinically confirmed HHT (presence of at least 3 Curaçao criteria) and/or confirmed by molecular biology.
Patient presenting nosebleeds with total duration > 30 minutes for 6 weeks prior to the time of inclusion justified by completed follow-up grids.

Exclusion Criteria:

Women who are pregnant or nursing (lactating), women of child-bearing potential without reliable contraception.
Patients not affiliated to a social security scheme.
Patients who are protected adults under the terms of the law (French Public Health Code).
Refusal to consent.
Patients for whom the diagnosis of HHT has not been confirmed clinically and/or by molecular biology.
Participation in another clinical trial which may interfere with the proposed trial (judgment of the investigator).
Patients who have undergone nasal surgery in the 6 weeks prior to inclusion.
Known hypersensitivity to macrolides in general, to tacrolimus or to any of the excipients.
Patient with an inherited skin barrier disease such as Netherton's syndrome, lamellar ichtyosis, generalized erythroderma, graft-versus-host skin disease, or suffering from generalized erythroderma.
Patient with CYP3A4 inhibitors treatment, e.g. erythromycin, itraconazole, ketoconazole and diltiazem.
Patients who have incompletely filled in the nosebleed grids in the 10 weeks preceding the treatment. If there is missing data for more than 7 days, the patient cannot be included.
Patients who do not present nosebleeds with a total duration of > 30 minutes for 6 weeks prior to the time of inclusion.
Patients with ongoing immunosuppressive treatment.
Patients with known and symptomatic immune deficiency
Intervention: Licogliflozin
Trial phase: Phase 2
SMILES: CCc1ccc([C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)cc1Cc1ccc2c(c1)OCCO2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: LIK066 2.5mg once daily
Eligibility criteria:
Key Inclusion Criteria:

BMI ≥ 22kg/m^2
Type 2 diabetes with HbA1c between 6.5% and 10.0%
Documented symptomatic chronic heart failure (NYHA II-IV)
Plasma NT-proBNP > 300pg/ml
eGFR ≥ 45ml/min/1.73m^2 (calculated by MDRD)

Key Exclusion Criteria:

Pregnant or nursing (lactating) women
Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
History of ketoacidosis, lactic acidosis, or hyperosmolar coma
Symptomatic genital infection or UTI within 4 weeks of screening
Myocardial infarction, stroke, surgery for heart disease, percutaneous coronary intervention within 3 months of randomization
Unstable angina within 3 months of screening
Isolated right HF due to pulmonary disease
Patients with a mean sitting systolic blood pressure ≤ 100mmHg, at randomization
History of lower limb amputation
Diabetic foot ulcer at screening
Intervention: Licogliflozin
Trial phase: Phase 2
SMILES: CCc1ccc([C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)cc1Cc1ccc2c(c1)OCCO2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: LIK066 50mg once daily
Eligibility criteria:
Key Inclusion Criteria:

BMI ≥ 22kg/m^2
Type 2 diabetes with HbA1c between 6.5% and 10.0%
Documented symptomatic chronic heart failure (NYHA II-IV)
Plasma NT-proBNP > 300pg/ml
eGFR ≥ 45ml/min/1.73m^2 (calculated by MDRD)

Key Exclusion Criteria:

Pregnant or nursing (lactating) women
Type 1 diabetes, monogenic diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
History of ketoacidosis, lactic acidosis, or hyperosmolar coma
Symptomatic genital infection or UTI within 4 weeks of screening
Myocardial infarction, stroke, surgery for heart disease, percutaneous coronary intervention within 3 months of randomization
Unstable angina within 3 months of screening
Isolated right HF due to pulmonary disease
Patients with a mean sitting systolic blood pressure ≤ 100mmHg, at randomization
History of lower limb amputation
Diabetic foot ulcer at screening
Intervention: Fenfluramine
Trial phase: Phase 3
ATC code: A08AA02 | A08AA04 | N03AX26
SMILES: CCNC(C)Cc1cccc(C(F)(F)F)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 89
Group description: The Paravertebral Block is performed along the spine utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)

Paravertebral Block: 20-30 mL 0.5% Ropivacaine
Eligibility criteria:
Inclusion Criteria:

Female patients ≥ 18 years of age
Total mastectomy or partial mastectomy with or without reconstruction OR planned lumpectomy.
Patient determined by their surgeon as medically able to receive a regional block for post-operative analgesia
Patient agrees to participate in the study and signs informed consent

Exclusion Criteria:

Neoadjuvant radiation therapy
Stage IV cancer
Previous breast surgery (excluding percutaneous biopsies of all types)
History of either PVB or PEC procedures
Planned general anesthesia use during surgery
Allergies to ropivacaine, midazolam, fentanyl, or propofol
Pregnant women
Prisoners
Adults unable to consent
Non-English-speaking patients
Intervention: Pituitrin
Trial phase: Phase 3
SMILES: NC(=O)CCC1NC(=O)C(Cc2ccccc2)NC(=O)C(Cc2ccc(O)cc2)NC(=O)C(N)CSSCC(C(=O)N2CCCC2C(=O)NC(CCCN=C(N)N)C(=O)NCC(N)=O)NC(=O)C(CC(N)=O)NC1=O.NCCCCC(NC(=O)C1CCCN1C(=O)C1CSSCC(N)C(=O)NC(Cc2ccc(O)cc2)C(=O)NC(Cc2ccccc2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(N)=O)C(=O)N1)C(=O)NCC(N)=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 89
Group description: The Pectoral Nerve Block is performed anteriorly, at the level of the axillary line, also utilizing ultrasound guided technique (20-30 mL 0.5% Ropivacaine)

Pectoral Nerve Block: 20-30 mL 0.5% Ropivacaine
Eligibility criteria:
Inclusion Criteria:

Female patients ≥ 18 years of age
Total mastectomy or partial mastectomy with or without reconstruction OR planned lumpectomy.
Patient determined by their surgeon as medically able to receive a regional block for post-operative analgesia
Patient agrees to participate in the study and signs informed consent

Exclusion Criteria:

Neoadjuvant radiation therapy
Stage IV cancer
Previous breast surgery (excluding percutaneous biopsies of all types)
History of either PVB or PEC procedures
Planned general anesthesia use during surgery
Allergies to ropivacaine, midazolam, fentanyl, or propofol
Pregnant women
Prisoners
Adults unable to consent
Non-English-speaking patients
Intervention: Macitentan
Trial phase: Phase 3
ATC code: C02KX04 | C02KX54
SMILES: CCCNS(=O)(=O)Nc1ncnc(OCCOc2ncc(Br)cn2)c1-c1ccc(Br)cc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 68
Group description: Participants received Macitentan 10 milligrams (mg) tablet, orally once daily with or without food starting at Week 0 up to Week 52.
Eligibility criteria:
Inclusion Criteria:

Written informed consent/assent from the subject and/or a legal representative prior to initiation of any study-mandated procedures
Fontan-palliated subjects with either intra-atrial lateral tunnel total cavopulmonary connection (LT-TCPC), or extra cardiac tunnel TCPC (EC-TCPC) surgery > 1 year before Screening. Either LT- or EC-TCPC can be primary or secondary to atrio-pulmonary connection
New York Heart Association (NYHA) functional class (FC) II or III (assessed by the investigator using the Specific Activity Scale
Women of childbearing potential must have a negative serum pregnancy test use reliable contraception

Exclusion Criteria:

Pattern of Fontan circulation severity
Deterioration of the Fontan-palliated condition.
Limitations to Cardiopulmonary exercise testing (CPET)
Peak VO2 < 15 mL/kg/min.
Any known factor or disease that may interfere with treatment compliance or full participation in the study
Intervention: Diacerein
Trial phase: Phase 2
ATC code: M01AX21
SMILES: CC(=O)Oc1cccc2c1C(=O)c1c(OC(C)=O)cc(C(=O)O)cc1C2=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: diacerein 1% ointment will be used for 8 weeks

diacerein 1% ointment: diacerein 1% ointment administered topically
Eligibility criteria:
Key Inclusion Criteria:

Subject is at least 4 years of age at Screening
Subject has a documented genetic mutation consistent with EBS. Gene mutations acceptable for inclusion are as follows: KRT5, KRT14, PLEC1, TGM5, PKP1, DSP, FERMT1, EXPH5, DST, KLHL24.

Subject has an Assessment Area of EBS lesions to be treated, that is ≥2% body surface area (BSA) and the EBS lesions are in one or both of the following body areas:

Localized: plantar and/or palmar areas
Generalized: arms, legs, torso, hands and feet
Subject's EBS lesions in the Assessment Area have an Investigator's Global Assessment (IGA) score of ≥3
Subject/caregiver agrees to not use any topical therapies other than the study medication that might influence the status of the EBS lesions during the duration of the study
Subject is non-pregnant as confirmed by a negative urine pregnancy screen, non-lactating and is not planning for pregnancy during the study period
If the subject is a woman of childbearing potential, agrees to use an approved effective method of birth control
Subject is in good general health and free of any known disease state or physical condition which might impair evaluation of the EBS lesions or which exposes the subject to an unacceptable risk by study participation

Key Exclusion Criteria:

Subject has EBS lesions to be treated that are infected
Subject has used any diacerein containing product within 6 months prior to Screening
Subject has used systemic immunotherapy or cytotoxic chemotherapy within 60 days prior to Screening
Subject has used systemic steroidal therapy or has used topical steroidal therapy on the EBS lesions to be treated within 30 days prior to Baseline
Subject has evidence of a systemic infection or has used systemic antibiotics within 7 days prior to Screening
Subject is currently using systemic analgesics and/or anti-histamine therapy, for treatment of EBS lesions unless on a stable regimen (i.e., the same dosing regimen) for at least 4 weeks prior to Screening
Subject has used any systemic diuretics or cardiac glycosides or any systemic product that might put the subject at undue risk
Subject has used any topical product containing allantoin on the EBS lesions to be treated within 30 days prior to Screening
Subject has a current malignancy, or a history of treatment for a malignancy within 2 years prior to Screening
Subject currently has diabetes mellitus (HbA1c ≥6.5%) or controlled diabetes (HbA1c < 6.5%)
Subject has a history of cardiac, hepatic (ALT and or AST >2x ULN, Total bilirubin >1.5x ULN at Screening), or renal disease (eGFR<30 ml/min/1.73 m^2)
Subject has a non-EBS skin disease or condition (e.g., sunburn) that might put the subject at undue risk by study participation or interferes with the study medication application or the study assessments
Intervention: Ropivacaine
Trial phase: Phase 4
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site deep to the serratus anterior muscle.

Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.
Eligibility criteria:
Inclusion Criteria:

Adult patients 18 years or older
Individuals undergoing either a mastectomy or mastectomy with tissue expander for which the anesthetic plan includes a serratus anterior plane block.

Exclusion Criteria:

Any known sensory deficit of the anterolateral chest wall.
Any local disorder of the skin or otherwise where blockade is to be performed which would prevent safe performance of the block
Pregnancy
American Society of Anesthesiology classification greater than 3
Allergy to amide local anesthetic medications
Chronic pain conditions
Preoperative opioid use greater than 20 oral morphine equivalents per day
Any coagulation abnormality which would be a contraindication for block placement
Preoperative chronic renal dysfunction requiring renal replacement therapy or a serum creatinine greater than 1.4 mg/dL
Body mass index >50
Incarceration
Inability to understand study procedures including inability to understand the English language
Inability to provide adequate informed consent
Refusal to participate in the study
Intervention: Ropivacaine
Trial phase: Phase 4
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: A regional block using of ropivacaine 0.35% (30 mL will be used per side in patients weighing over 60 kg and 20 mL will be used in patients weighing less than 60 kg) will be administered to the injection site superficial to the serratus anterior muscle.

Ropivacaine 0.35%: The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.
Eligibility criteria:
Inclusion Criteria:

Adult patients 18 years or older
Individuals undergoing either a mastectomy or mastectomy with tissue expander for which the anesthetic plan includes a serratus anterior plane block.

Exclusion Criteria:

Any known sensory deficit of the anterolateral chest wall.
Any local disorder of the skin or otherwise where blockade is to be performed which would prevent safe performance of the block
Pregnancy
American Society of Anesthesiology classification greater than 3
Allergy to amide local anesthetic medications
Chronic pain conditions
Preoperative opioid use greater than 20 oral morphine equivalents per day
Any coagulation abnormality which would be a contraindication for block placement
Preoperative chronic renal dysfunction requiring renal replacement therapy or a serum creatinine greater than 1.4 mg/dL
Body mass index >50
Incarceration
Inability to understand study procedures including inability to understand the English language
Inability to provide adequate informed consent
Refusal to participate in the study