anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Hydromorphone
Trial phase: Phase 4
ATC code: N02AA03 | N02AA53 | N02AG04
SMILES: [H][C@@]12CCC(=O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 120
Group description: Participants received hydromorphone oral osmotic system OROS (8 milligram [mg] to greater than or equal to 32 mg) once daily for 2 weeks, in a dose adjusted according to previously administered strong oral opioid analgesic (dose with equivalent analgesic effect; hydromorphone OROS dose: oral morphine dose=1:5) hydromorphone OROS was continued as per Investigator's discretion for additional 84 days of extension phase.
Eligibility criteria:
Inclusion Criteria:

Participants who are currently receiving strong opioid analgesic (drug used to control pain) for their cancer pain management
Participants whose arithmetical mean of sleep disturbance caused by pain measured with Numeric Rating Scale for 3 days before Visit 2 (Day 1) is equal to or greater than 4 points
Participants who are able, in the opinion of Investigator, to comply fully with the trial requirements including completion of the Korean-Brief Pain Inventory
Participants who have signed an informed consent form

Exclusion Criteria:

Participants with pain who are not likely to response to opioid analgesics
Participants who are intolerant or hypersensitive to hydromorphone
Participants with the following digestive tract diseases which is serious enough to interfere action of an oral analgesic; diseases which can affect absorption and transit of oral drugs such as dysphagia (trouble swallowing), vomiting, no bowel movement, intestinal obstruction, serious intestinal stenosis (narrowing of a duct, tube, or 1 of the valves in the heart), etc
Female participants of childbearing potential who are pregnant or lactating, seeking pregnancy, or failing to take adequate contraceptive precautions
Participants in whom the risks of treatment with morphine/hydromorphone outweigh the potential benefits, including such risk categories as raised intracranial pressure, hypotension, hypothyroidism, asthma, compromised respiratory function compromised liver function, convulsive (an involuntary contraction or series of contractions of the voluntary muscles) disorder and Addison disease (disorder that occurs when the adrenal glands do not produce enough of their hormones)
Intervention: Atorvastatin
Trial phase: Phase 4
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Patients are randomized to either atorvastatin or placebo once daily for 12 weeks. There is a 4 week washout, and then the groups are switched for 12 weeks. Brachial artery assessment will be performed before and after each 12 week period on therapy.
Eligibility criteria:
Inclusion Criteria:

patients over the age of 18 years with repaired coarctation of the aorta (CoA) and willing to participate in all portions of the study including follow up, blood draws, urine sample, echocardiogram, MRI, brachial artery flow-mediated dilatation (FMD) testing, Carotid Intima Media Thickness (CIMT) testing and statin administration.

Exclusion Criteria:

patients who are pregnant, nursing, or planning on becoming pregnant in the subsequent year
current smokers
patients with documented coronary artery disease (CAD), other systemic inflammatory disorder such as systemic lupus erythematosis or rheumatoid arthritis
patients already on statin therapy or who have had previous adverse effects to statin therapy
patients with hepatic transaminases >2X the upper limit of normal
patients with creatinine clearance <60mg/dL
patients who have implanted devices such as pacemakers or defibrillators that preclude MRI testing
patients with low blood pressure at baseline (< 90/50)
patients who are unwilling or unable to comply with the aforementioned portions of the study
Intervention: Propofol
Trial phase: Not Applicable
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Anesthetic Drug Infusion

Propofol 0.90mcg/mL: IV Propofol infusion for 2 hours.
Eligibility criteria:
Inclusion Criteria:

age between 18 and 50
minimum of high school education
fluent in English
normal vocabulary

Exclusion Criteria:

any significant medical or psychiatric comorbidity (e.g. asthma, diabetes, hypertension, depression, high anxiety)--subjects must be in excellent health such that they would be classified as American Society of Anesthesiologists Physical Status Class I
deficit in vision or hearing that would impede the study
allergies to any of the study drugs, to soybeans, or to eggs
a history of head trauma
a family history of major psychiatric illness
body mass index > 30 kg/m2
a recent history of recreational drug use
prior exposure to the study materials
pregnancy
a personal or family history of any porphyria
failure to exhibit a skin conductance response to deep inspiration
the ability to read Chinese characters
assessment by the investigators that the subject may be unable to cooperate or comply with the study requirements.
Intervention: Thiopental
Trial phase: Not Applicable
ATC code: N01AF03 | N05CA19 | N05CB01
SMILES: CCCC(C)C1(CC)C(=O)NC(=S)NC1=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: Anesthetic Drug Infusion

Thiopental 1.5mcg/mL: IV Thiopental 1.5mcg/mL infusion for 2 hours
Eligibility criteria:
Inclusion Criteria:

age between 18 and 50
minimum of high school education
fluent in English
normal vocabulary

Exclusion Criteria:

any significant medical or psychiatric comorbidity (e.g. asthma, diabetes, hypertension, depression, high anxiety)--subjects must be in excellent health such that they would be classified as American Society of Anesthesiologists Physical Status Class I
deficit in vision or hearing that would impede the study
allergies to any of the study drugs, to soybeans, or to eggs
a history of head trauma
a family history of major psychiatric illness
body mass index > 30 kg/m2
a recent history of recreational drug use
prior exposure to the study materials
pregnancy
a personal or family history of any porphyria
failure to exhibit a skin conductance response to deep inspiration
the ability to read Chinese characters
assessment by the investigators that the subject may be unable to cooperate or comply with the study requirements.
Intervention: Thiopental
Trial phase: Not Applicable
ATC code: N01AF03 | N05CA19 | N05CB01
SMILES: CCCC(C)C1(CC)C(=O)NC(=S)NC1=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: Anesthetic Drug Infusion

Thiopental 3mcg/mL: IV Thiopental 3mcg/mL infusion for 2 hours
Eligibility criteria:
Inclusion Criteria:

age between 18 and 50
minimum of high school education
fluent in English
normal vocabulary

Exclusion Criteria:

any significant medical or psychiatric comorbidity (e.g. asthma, diabetes, hypertension, depression, high anxiety)--subjects must be in excellent health such that they would be classified as American Society of Anesthesiologists Physical Status Class I
deficit in vision or hearing that would impede the study
allergies to any of the study drugs, to soybeans, or to eggs
a history of head trauma
a family history of major psychiatric illness
body mass index > 30 kg/m2
a recent history of recreational drug use
prior exposure to the study materials
pregnancy
a personal or family history of any porphyria
failure to exhibit a skin conductance response to deep inspiration
the ability to read Chinese characters
assessment by the investigators that the subject may be unable to cooperate or comply with the study requirements.
Intervention: Duloxetine
Trial phase: Phase 3
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 198
Group description: Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
Eligibility criteria:
Inclusion Criteria:

Male or female outpatients with chronic low back pain

Exclusion Criteria:

Cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
Acute liver injury (such as hepatitis) or severe cirrhosis.
Previous exposure to duloxetine.
Body Mass Index (BMI) over 40.
Major depressive disorder.
Daily use of narcotics.
Intervention: Aliskiren
Trial phase: Phase 2
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Aliskiren 300 mg once daily for 12 weeks
Eligibility criteria:
Inclusion criteria:

Type 1 or type 2 diabetes
Diabetic macular edema

Exclusion criteria:

Recent intra-ocular surgery in the study eye (e.g., cataract surgery in the last 6 months)
Recent laser photocoagulation in the study eye
Recent treatment with Avastin, Lucentis, or intravitreal corticosteroids in the study eye

Other protocol-defined inclusion/exclusion criteria applied
Intervention: Sunitinib
Trial phase: Phase 2
ATC code: L01EX01
SMILES: CCN(CC)CCNC(=O)c1c(C)[nH]c(/C=C2\C(=O)Nc3ccc(F)cc32)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Sunitinib : Taken orally once a day in the evening
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically confirmed epithelial ovarian, fallopian tube or peritoneal cancer
Recurrent or refractory disease
Measurable disease, defined by RECIST
0 to 3 prior cytotoxic chemotherapy or biologic regimens for metastatic disease
Adverse events related to prior tumor-specific therapy must have resolved to less than or equal to grade 1 prior to study entry
Ability to swallow oral medications
18 years of age or older
ECOG Performance status must be 0-2
Normal organ and marrow function as outlined in the protocol

Exclusion Criteria:

Receiving systemic therapy less than 14 days prior to starting sunitinib
Receiving any other investigational agent
Received prior sunitinib
Untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on screening CT or MRI scans
Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
Evidence of a bleeding diathesis. Major surgery or NCI CTCA 3.0 grade 3 or worse hemorrhage within 4 weeks of starting study treatment
Ongoing cardiac dysrhythmias of NCI CTCAE version 3.0 grade > 2
Pre-existing thyroid abnormality, with thyroid function tests that cannot be maintained in the normal range with medication
Prolonged QTc interval on baseline EKG
Uncontrolled hypertension
Patients who are taking cytochrome P450 enzyme-inducing antiepileptic drugs, rifampin, theophylline, ketoconazole, or St. John's wort.
Psychiatric illness or social situations that wold limit compliance with study requirements
Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration
Pregnant women
Clinical or radiographical evidence of a small bowel obstruction
Poor oral intake
Intervention: Econazole Nitrate
Trial phase: Phase 2
SMILES: Clc1ccc(COC(Cn2ccnc2)c2ccc(Cl)cc2Cl)cc1.O=[N+]([O-])O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Econazole Nitrate Cream 1%
Eligibility criteria:
Inclusion Criteria:

Be at least 18 years or age and of either sex.
Has a clinical diagnosis of tinea pedis with at least i) moderate scaling(interdigital and/or moccasin) and ii) mild erythema (interdigital only).
Be willing to give informed consent.
Be willing and able to give informed consent.
Has microscopic evidence (positive KOH) of the presence of fungi. Evaluable subjects must have a positive KOH and a fungal culture positive for a dermatophyte at Baseline. Subjects with a positive KOH may be entered into the study pending the results of the fungal culture.
Be in good health and free of any disease or physical condition which might, in the investigator's opinion, expose the subject to an unacceptable risk by study participation.
Women of childbearing potential must have a negative urine pregnancy test and agree to use an effective, non-prohibited form of birth control for the duration of the study (abstinence, stabilized on oral contraceptives for at least two months, implant, injection, IUD, patch, NuvaRing, condom and spermicidal or diaphragm and spermicidal).

Exclusion Criteria:

Is nursing or planning a pregnancy during the study.
Has used topical antifungal or corticosteroid therapy or systemic antibacterial therapy within 30 days prior to the start of the study.
Has received systemic antifungal therapy within 12 weeks prior to the start of the study medication.
Has a history of diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
Has concurrent tinea infection (in the opinion of the investigator). However, concurrent onychomycosis is allowed.
Has any other skin disease which might interfere with the evaluation of tinea pedis.
Is currently enrolled in an investigational drug or device study.
Has received an investigational drug or treatment with an investigational device within 30 days prior to entering this study
Is unreliable, including subjects with a history of drug or alcohol abuse.
Has known hypersensitivity to any of the components of the study medications.
Intervention: Econazole Nitrate
Trial phase: Phase 2
SMILES: Clc1ccc(COC(Cn2ccnc2)c2ccc(Cl)cc2Cl)cc1.O=[N+]([O-])O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: Econazole Nitrate Foam 1%
Eligibility criteria:
Inclusion Criteria:

Be at least 18 years or age and of either sex.
Has a clinical diagnosis of tinea pedis with at least i) moderate scaling(interdigital and/or moccasin) and ii) mild erythema (interdigital only).
Be willing to give informed consent.
Be willing and able to give informed consent.
Has microscopic evidence (positive KOH) of the presence of fungi. Evaluable subjects must have a positive KOH and a fungal culture positive for a dermatophyte at Baseline. Subjects with a positive KOH may be entered into the study pending the results of the fungal culture.
Be in good health and free of any disease or physical condition which might, in the investigator's opinion, expose the subject to an unacceptable risk by study participation.
Women of childbearing potential must have a negative urine pregnancy test and agree to use an effective, non-prohibited form of birth control for the duration of the study (abstinence, stabilized on oral contraceptives for at least two months, implant, injection, IUD, patch, NuvaRing, condom and spermicidal or diaphragm and spermicidal).

Exclusion Criteria:

Is nursing or planning a pregnancy during the study.
Has used topical antifungal or corticosteroid therapy or systemic antibacterial therapy within 30 days prior to the start of the study.
Has received systemic antifungal therapy within 12 weeks prior to the start of the study medication.
Has a history of diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
Has concurrent tinea infection (in the opinion of the investigator). However, concurrent onychomycosis is allowed.
Has any other skin disease which might interfere with the evaluation of tinea pedis.
Is currently enrolled in an investigational drug or device study.
Has received an investigational drug or treatment with an investigational device within 30 days prior to entering this study
Is unreliable, including subjects with a history of drug or alcohol abuse.
Has known hypersensitivity to any of the components of the study medications.
Intervention: Acyclovir
Trial phase: Phase 3
ATC code: D06BB03 | D06BB53 | J05AB01 | S01AD03
SMILES: Nc1nc2c(ncn2COCCO)c(=O)[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 378
Group description: Acyclovir Lauriad 50mg muco-adhesive tablet
Eligibility criteria:
Inclusion Criteria:

History of recurrent herpes labialis lesions where:

At least 50% of previous episodes produced classical lesions to the vesicular stage (i.e. episodes that progressed through macula, papule, vesicle, crust and healed);
Prodromal symptoms (itching, tingling, pain etc.) should precede herpes labialis lesions in at least 50% of the previous herpes episodes
Good general health (ECOG < 2), immunocompetent
Signed and dated written informed consent
Women of childbearing potential must have effective contraception method

Exclusion Criteria:

More than 50% of recurrences that aborted spontaneously in the past 12 months
Primary herpes lesion outside the lips (e.g. nose, chin, etc.)
Abnormal peri-oral skin condition that might affect the normal course of cold sores (e.g. eczema, psoriasis…)
Oral diseases whose prodromal symptoms may mimick those of herpes labialis, including recurrent oral aphthous disease
Oral diseases that might interfere with the evaluation of the efficacy or safety of the treatments, including gingivitis, parondotis, mucositis, oropharyngeal candidiasis…
History of infection known to be resistant to acyclovir family agents
Previous vaccination against herpes
Concomitant treatment likely to interfere with acyclovir
Allergy to any acyclovir containing agents
Immunocompromised condition, including HIV+
Unability to properly understand protocol requirements, to follow the study procedures, to complete the patient diary or to start the self-initiation of the treatment
Upper full or partial dentures with acrylic border in the canine fossa
Milk allergy or known history of hypersensitivity to one of the components of the products
Rare hereditary problems of galactose intolerance.
Lactase enzyme deficiency or glucose galactose malabsorption
Clinically significant abnormal level of serum creatinine
Patients whose occupations make them unlikely to return to the clinic within 24h of treatment initiation
Pregnancy or breast-feeding
Investigational drug or immunomodulator treatment in the 30 days prior randomisation
Prior enrollment in this study
Participation in another therapeutic trial evaluating new drugs or which could interfere with the evolution of herpes labialis or the evaluation of the drug in the study within preceding 30 day.
Intervention: Ketotifen
Trial phase: Phase 3
ATC code: R06AX17 | S01GX08
SMILES: CN1CCC(=C2c3ccccc3CC(=O)c3sccc32)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 144
Group description: Ketotifen fumarate 0.025% ophthalmic solution

Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.
Eligibility criteria:
Inclusion Criteria:

Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
Positive bilateral CAC reaction in at least 2 out of 3 time points at visit 2.

Exclusion Criteria:

Known contraindications or sensitivities to the study medication or its components.
Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
Use of disallowed medications during the period indicated prior to study enrollment or during the study.
Intervention: Naphazoline
Trial phase: Phase 3
ATC code: R01AA08 | R01AB02 | S01GA01 | S01GA51
SMILES: c1ccc2c(CC3=NCCN3)cccc2c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 144
Group description: Naphazoline HCl 0.05% ophthalmic solution

Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.
Eligibility criteria:
Inclusion Criteria:

Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
Positive bilateral CAC reaction in at least 2 out of 3 time points at visit 2.

Exclusion Criteria:

Known contraindications or sensitivities to the study medication or its components.
Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
Use of disallowed medications during the period indicated prior to study enrollment or during the study.
Intervention: Ketotifen
Trial phase: Phase 3
ATC code: R06AX17 | S01GX08
SMILES: CN1CCC(=C2c3ccccc3CC(=O)c3sccc32)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 141
Group description: Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.

Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
Eligibility criteria:
Inclusion Criteria:

Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
Positive bilateral conjunctival allergen challenge(CAC) reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
Positive bilateral CAC reaction for at least 2 out of 3 time points at visit 2.

Exclusion Criteria:

Known contraindications or sensitivities to the study medication or its components.
Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
Use of disallowed medications during the period indicated prior to study enrollment or during the study.
Intervention: Naphazoline
Trial phase: Phase 3
ATC code: R01AA08 | R01AB02 | S01GA01 | S01GA51
SMILES: c1ccc2c(CC3=NCCN3)cccc2c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 141
Group description: Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.

Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
Eligibility criteria:
Inclusion Criteria:

Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
Positive bilateral conjunctival allergen challenge(CAC) reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
Positive bilateral CAC reaction for at least 2 out of 3 time points at visit 2.

Exclusion Criteria:

Known contraindications or sensitivities to the study medication or its components.
Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
Use of disallowed medications during the period indicated prior to study enrollment or during the study.