anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: DIMETHYL FUMARATE
Trial phase: Phase 4
ATC code: L04AX07
SMILES: [H]/C(C(=O)OC)=C(/[H])C(=O)OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 233
Group description: 120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
Eligibility criteria:
Key Inclusion Criteria:

Decision to treat with DMF must precede enrollment.
Naïve to DMF or fumaric acid esters.
Resides in the US and has a confirmed diagnosis of a relapsing form of MS.
Satisfies the approved therapeutic indication(s) for DMF.

Key Exclusion Criteria:

Inability to comply with study requirements or, at the discretion of the Investigator, is deemed unsuitable for study participation.
History of significant GI disease, chronic use of GI symptomatic therapy, active malignancies.
Is participating in any other interventional clinical trial.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Lisinopril
Trial phase: Phase 2
ATC code: C09AA03 | C09BA03 | C09BB03 | C10BX07
SMILES: NCCCC[C@H](N[C@@H](CCc1ccccc1)C(=O)O)C(=O)N1CCC[C@H]1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Beginning within 7 days of beginning radiation therapy, patients receive lisinopril PO QD.
Eligibility criteria:
Inclusion Criteria:

Histological confirmation of small cell and non-small cell carcinoma of the lung receiving thoracic radiotherapy > 45 Gy, with volume of lung receiving 20 Gy or more (V20Gy) >= 20%
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Absolute neutrophil count (ANC) >= 1500/mm^3
Platelet count >= 100,000/mm^3
Hemoglobin > 9.0 g/dL
Creatinine clearance >= 30 mL/min as calculated using actual body weight and Cockroft Gault formula
Initial physical exam with systolic blood pressure (BP) of > 100 mmHg and diastolic BP of > 60 mmHg
Potassium within institutional normal limits
Sodium within institutional normal limits
Negative pregnancy test done =< 14 days prior to registration, for women of childbearing potential only
Ability to complete questionnaire(s) by themselves or with assistance
Provide informed written consent
Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Willing to provide blood samples for correlative research purposes

Exclusion Criteria:

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Other active malignancy =< 3 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment (e.g., maintenance or adjuvant chemotherapy or hormonal therapy) for their cancer
History of myocardial infarction =< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
History of prior radiation therapy treatment to the lungs or thorax
Existing contraindications to angiotensin-converting enzyme (ACE) inhibitors such as hypersensitivity to ACE inhibitors, bilateral renal artery stenosis, angioedema, or previously documented adverse drug reaction to ACE inhibitors

Any of the following:

Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception
Use of ACE inhibitors (including lisinopril) or ACE receptor blockers (ARB) of any kind =< 90 days prior to registration
Intervention: Hexose
Trial phase: Phase 2
ATC code: V04CE01 | V06DC01
SMILES: OCC1OC(O)C(O)C(O)C1O
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.

Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx
Eligibility criteria:
Inclusion Criteria:

Children below 4 years of age

Exclusion Criteria:

None
Intervention: Salicylhydroxamic Acid
Trial phase: Phase 3
SMILES: O=C(NO)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 58
Group description: Single sham injection to the study eye at baseline
Eligibility criteria:
Inclusion Criteria:

Symptomatic vitreomacular adhesion (VMA) which, in the opinion of the Investigator, is related to decreased visual function;
Best corrected visual acuity (BCVA) of 20/25 or worse in the study eye;
BCVA of 20/800 or better in the non-study eye;
Provide written informed consent;
Follow specified instructions during study period;
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Evidence of proliferative retinopathy, exudative age-related macular degeneration, or retinal vein occlusion in the study eye;
Vitreous hemorrhage or other opacification;
High myopia in the study eye;
Ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior 3 months;
Uncontrolled glaucoma in the study eye;
History of retinal detachment in either eye;
Active infection in either eye;
Pregnant or of child-bearing potential and not utilizing acceptable form of contraception;
Participation in another investigational drug study within 30 days prior to this study;
Other protocol-defined exclusion criteria may apply.
Intervention: Selinexor
Trial phase: Phase 1
ATC code: L01XX66
SMILES: O=C(/C=C\n1cnc(-c2cc(C(F)(F)F)cc(C(F)(F)F)c2)n1)NNc1cnccn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Participants with advanced sarcomas (Liposarcoma, Leiomyosarcoma, and Other sarcoma) received Selinexor 60 mg/m^2 orally in treatment sequence BCA (Treatment B: new [2nd generation] tablets on Day 1 of Week 1; Treatment C: suspension dose of current [1st generation] tablets on Day 1 of Week 2; Treatment A: current [1st generation] tablets on Day 1 of Week 3 in Cycle 1 (Weeks 1 to 3). All participants received the current (1st generation) tablet formula at a dose of 60 mg on Day 3 of Weeks 1-3 of Cycle 1.
Eligibility criteria:
Inclusion Criteria:

Patients must have histologically confirmed soft tissue or bone/cartilage sarcoma. Patients with sarcoma of small round blue cell tumor types are allowed. Gastrointestinal stromal tumors (GIST) are excluded.
Patients must have received at least one prior anticancer regimen for metastatic disease unless there is no other therapy available and evidence of progressive disease on study entry. Patients with stable disease will be included if there has been failure to respond to another drug(s) within the previous 3 months

Exclusion Criteria:

Patients with known liver metastases
Radiation, chemotherapy, immunotherapy, any other systemic anticancer therapy or participation in an investigational anti-cancer study ≤ 3 weeks prior to initiation of therapy
Patients with known brain metastasis
Patients with any gastrointestinal dysfunctions that could interfere with the interpretation of the food effect data
Patients with known intolerance to low or high fat meals
In the opinion of the investigator, patients who are significantly below their ideal body weight
Intervention: Vismodegib
Trial phase: Phase 2
ATC code: L01XJ01 | L01XX43
SMILES: CS(=O)(=O)c1ccc(C(=O)Nc2ccc(Cl)c(-c3ccccn3)c2)c(Cl)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma
Free of any significant physical abnormalities (e.g., tattoos) at the target basal cell carcinoma site
Willing and able to participate in the study as an outpatient and agreement to make frequent visits to the clinic during the treatment and follow-up periods and to comply with study requirements

Exclusion Criteria:

Prior treatment with vismodegib
Known hypersensitivity to any of the study drug excipients
Any metastatic basal cell carcinoma
Any locally advanced basal cell carcinoma considered to be inoperable or to have a medical contraindication to surgery
Evidence of clinically significant and unstable diseases or conditions (e.g., cardiovascular, immunosuppressive, hematologic)
Any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination
Recent, current, or planned participation in another experimental drug study
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 63
Group description: dexmedetomidine/precedex

Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes
Eligibility criteria:
Inclusion Criteria:

ASA physical status of I or II
male or female, aged 1-7
has no significant lab abnormalities

Exclusion Criteria:

ASA physical status of III, IV or V
Presence of medicated behavioral disorder
Subjects for which dexmedetomidine, opiates, benzodiazepines or inhalational anesthetics are contraindicated.
Parental refusal
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.

Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.
Eligibility criteria:
Inclusion Criteria:

patients undergoing selected maxillofacial surgery with free flap reconstruction
American Society of Anesthesiologist(ASA) classification I and II

Exclusion Criteria:

bradycardia (< 50 bpm)
severe heart block
low blood pressure(SBP<80mmHg)
Known allergy to alpha 2 agonists
Intervention: Evacetrapib
Trial phase: Phase 1
SMILES: Cc1cc(C)c2c(c1)[C@@H](N(Cc1cc(C(F)(F)F)cc(C(F)(F)F)c1)c1nnn(C)n1)CCCN2C[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 26
Group description: Period 1:

Evacetrapib 130 mg administered orally as a single dose on Day 1.
Eligibility criteria:
Inclusion Criteria:

Overtly healthy males and females (of non child-bearing potential)
Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2), inclusive, at screening

Exclusion Criteria:

Have known allergies to evacetrapib, rifampin, related compounds or any components of either formulation, or history of significant allergic disease as determined by the investigator
Intervention: Pramoxine Hydrochloride
Trial phase: Phase 4
SMILES: CCCCOc1ccc(OCCCN2CCOCC2)cc1.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
Eligibility criteria:
Inclusion Criteria:

Patients who meet all of the following criteria are eligible for this study:

Male and female subjects who are 60-80 years of age, with phototypes I to IV.
Subjects who have provided written, informed consent.
Subjects with multiple bruises on both forearms and hands.
Subjects with moderate to severe photodamage on forearms and hands.
Subjects with relatively equal photodamage on both forearms and hands.
Subjects who are willing to follow the treatment schedule.
Subjects who are willing to maintain their usual sunscreen or use of photoprotective clothing during outdoor activities.

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for this study:

Participation in a clinical drug or device research study within 30 days of enrollment or participation in a research study concurrent with this study;
Subjects with history of bleeding disorders;
Subjects with use of isotretinoin in the past 12 months;
Subjects with a pacemaker or internal defibrillator;
Subjects who take more than 2 anticoagulant therapies.
Treatment of any type of cancer within the last 6 months;
Subjects who are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function;
History of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure, including known sensitivities to any ingredient;
Concomitant use of potentially irritating over-the-counter products that contain ingredients such as arnica, alpha-hydroxy acid, salicylic acid, retinol or glycolic acid;
Subjects who present with one or more conditions which, in the opinion of the investigator, making the subject unsuitable for participation.
Subjects who apply any topicals other than the study treatment or their usual sunscreen.
Intervention: Fenoterol
Trial phase: Not Applicable
ATC code: G02CA03 | R03AC04 | R03AL01 | R03CC04
SMILES: CC(Cc1ccc(O)cc1)NCC(O)c1cc(O)cc(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Ventilator support
Determining personal target airway resistance
Bronchodilator:Salmeterol/fluticasone 4 puffs inhalation every 12 hours until ventilator discontinuation or the 28th day if ventilator-dependent
Bronchodilator:Ipatropium/salbutamol 1 vial inhalation every 6 hours for the first 3 days
Steroid:Methylprednisolone 40 mg intravenous injection every 8 hours for the first 3 days
Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide) 4 puffs plus fenoterol (Berotec) 4 puffs inhalation if personal target airway resistance (measured every 8 hours) not met (until ventilator discontinuation or the 28th day if ventilator-dependent) salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Additional broncho-dilators inhalation: Salmeterol/fluticasone (Seretide Evohaler) 4 puffs plus fenoterol (Berotec)(0
Eligibility criteria:
Inclusion Criteria:

chronic obstructive pulmonary disease
acute respiratory failure under ventilator support for less than 72 hours
endotracheal tube inserted

Exclusion Criteria:

confirmed asthma
Acute Physiology and Chronic Health Evaluation II score over 35
a co-morbidity of septic shock
Intervention: Fenoterol
Trial phase: Not Applicable
ATC code: G02CA03 | R03AC04 | R03AL01 | R03CC04
SMILES: CC(Cc1ccc(O)cc1)NCC(O)c1cc(O)cc(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Ventilator support
Determining personal target airway resistance
Bronchodilator:Salmeterol/fluticasone 4 puffs inhalation every 12 hours until ventilator discontinuation or the 28th day if ventilator-dependent
Bronchodilator:Ipatropium/salbutamol 1 vial inhalation every 6 hours for the first 3 days
Steroid:Methylprednisolone 40 mg intravenous injection every 8 hours for the first 3 days
No additional bronchodilator given if personal target airway resistance (measured every 8 hours) not met salmeterol/fluticasone: Each puff contains 25 mcg salmeterol /250 mcg fluticasone ipatropium/salbutamol: Each vial contains ipatropium bromide 0.5 mg and salbutamol sulfate 2.5 mg Methylprednisolone Determining personal target airway resistance: Three consecutive doses of 4, 8 and 16 puffs of fenoterol MDI (100 mcg/puff, Berotec;Boehringer Ingelheim, Ingelheim, Germany) inhalation with each dose 15 minutes apart. The airway resistance measured 15 minutes later is assigned as th
Eligibility criteria:
Inclusion Criteria:

chronic obstructive pulmonary disease
acute respiratory failure under ventilator support for less than 72 hours
endotracheal tube inserted

Exclusion Criteria:

confirmed asthma
Acute Physiology and Chronic Health Evaluation II score over 35
a co-morbidity of septic shock
Intervention: Frovatriptan
Trial phase: Phase 3
ATC code: N02CC07
SMILES: CN[C@@H]1CCc2[nH]c3ccc(C(N)=O)cc3c2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 290
Group description: SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70

SB2 (proposed biosimilar to infliximab)
Eligibility criteria:
Inclusion Criteria:

Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months
Have moderate to severe active disease despite MTX therapy defined as having more than or equal to six swollen joints and more than or equal to six tender joints and either erythrocyte sedimentation rate (ESR, Westergren) ≥ 28 mm/h or serum C-reactive protein ≥ 1.0 mg/dL
Must have been treated with MTX for at least 6 months prior to Randomisation and on a stable dose of MTX 10-25 mg/week given at least 4 weeks prior to Screening
Female subjects who are not pregnant or nursing at Screening and who are not planning to become pregnant from Screening until 6 months after the last dose of investigational product

Inclusion Criteria for Transition-Extension Period:

Have been enrolled and completed the scheduled Week 54 visit of the randomised, double-blind period of the SB2-G31-RA study
In the opinion of the Investigator, subjects who may benefit from continuing IP treatment (either SB2 or Remicade), understand the implications of taking part in the study and willing to participate in the transition-extension period

Exclusion Criteria:

Have been treated previously with any biological agents including any tumour necrosis factor inhibitor
Have a known hypersensitivity to human immunoglobulin proteins or other components of Remicade or SB2
Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus
Have a current diagnosis of active tuberculosis
Have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to Randomisation.

Have any of the following conditions

Other inflammatory or rheumatic diseases.
History of any malignancy within the previous 5 years prior to Screening
History of lymphoproliferative disease including lymphoma.
History of congestive heart failure
Physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).
History of demyelinating disorders.

Exclusion Criteria for Transition-Extension Period:

Have been withdrawn from the SB2-G31-RA study for any reason
Have had any significant medical conditions, such as an occurrence of a serious AE (SAE) or intolerance of SB2 or Remicade during the randomised, double-blind period of the SB2-G31-RA study which may render the subject unsuitable to participate in the transition-extension period, at the discretion of the Investigator
Intervention: Emricasan
Trial phase: Phase 2
SMILES: C[C@H](NC(=O)C(=O)Nc1ccccc1C(C)(C)C)C(=O)N[C@@H](CC(=O)O)C(=O)COc1c(F)c(F)cc(F)c1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Dosed twice daily

IDN-6556
Eligibility criteria:
Inclusion Criteria:

Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
Subjects with a clinical, radiological and/or histological diagnosis of cirrhosis
Subjects having not required hospital admission within 4 weeks of screening for a complication of cirrhosis
Subjects with an acute deterioration of liver function

Subjects who meet one of the following criteria:

Subjects with renal failure (defined as creatinine ≥ 2.0 to ≤ 3.4 mg/dL)
Subjects with other single organ failure with i. Renal impairment (defined as an increase in creatinine of > 0.3 mg/dL from either an established prior Baseline level or if applicable, upon admission to hospital if prior level is unavailable; for inclusion, the creatinine level must be raised above normal levels), and/or ii. Hepatic encephalopathy grade I or II
Subjects with two organ failures
If a subject received steroids for alcohol-induced acute liver failure, he/she must be unresponsive to steroid therapy. Responsiveness is based on investigator discretion.
Willingness to utilize two reliable forms of contraception (for both males and females of childbearing potential) from screening to one month after the last dose of study drug

Exclusion Criteria:

Known infection with HIV
Subjects with cirrhosis who develop decompensation at any time in the postoperative period following partial hepatectomy
Subjects with evidence of uncontrolled infection defined as persistent bacterial culture positivity despite adequate antibiotic therapy
Subjects with clinical evidence of disseminated intravascular coagulation
Subjects with chronic and/or pre-existing kidney disease defined as eGFR (estimated glomerular filtration rate) of less than 30 mL/min for 3 months or longer
Subjects who are hypotensive (defined as mean arterial pressure <70 mmHg) or require the use of inotropic support
Subjects with evidence of significant and/or uncontrolled bleeding
Subjects requiring mechanical ventilation
Subjects with active or history of malignancies other than hepatocellular carcinoma (HCC) within Milan criteria or curatively treated skin cancer (basal cell or squamous cell carcinomas), unless adequately treated or in complete remission for five or more years
Subjects previously exposed to IDN-6556
History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QT or QTc interval of > 480 milliseconds (msec)