anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ioflupane I-123
Trial phase: Phase 2
ATC code: V09AB03
SMILES: COC(=O)C1C(c2ccc(I)cc2)CC2CCC1N2CCCF
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: 185 megabecquerel (MBq) of Ioflupane I-123 will be administered IV to patients with suspected renal cell carcinoma, at a single occasion and followed by SPECT-analysis 5h after injection.

Ioflupane I123: 185 MBq ioflupane I133 will be administered at one single occasion to the study subjects
Eligibility criteria:
Inclusion Criteria:

suspected kidney cancer diagnosis
suspected spread of the cancer
patient is scheduled for surgery alternatively biopsy of kidney tumor
patient is 18 years or older
the patient has given their consent to participate in the study
female patients of reproductive age displays negative pregnancy test

Exclusion Criteria:

known or suspected allergy to Ioflupane or sodium acetate or acetic acid or ethanol
patient suffers from moderate to severe renal impairment and exhibits glomerular filtration rate (GFR) <40
patient is medicated for Parkinson's disease
patient is medicated with any of the following medications: amphetamine, benzatropine, buproprion, cocaine, mazindol, methylphenidate, phentermine, sertraline, levodopa, dexamphetamine, lisdexamphetamine, modafinil, moclobemid, venlafaxine
patient is pregnant
breastfeeding
patient suffers from mental inability unwillingness or language difficulties resulting in difficulty in understanding the meaning of taking part in the study
Intervention: Nateglinide
Trial phase: Phase 3
ATC code: A10BX03
SMILES: CC(C)[C@H]1CC[C@H](C(=O)N[C@H](Cc2ccccc2)C(=O)O)CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 44
Group description: Nano silver fluoride solution (Prepared in Nanotech Co., Egypt) based on silver nanoparticles, chitosan and fluoride. Each tooth will receive two drops of NSF with a micro brush, equivalent to a dose of 10 mg of the solution.

Nano silver fluoride solution: Nano silver fluoride that composed of silver nanoparticles, chitosan and fluoride that combines preventive and antimicrobial properties.
Eligibility criteria:
Inclusion Criteria:

Inclusion Criteria of participants:

Not received antibiotic therapy since 1 month before sampling.
Good oral hygiene.
Co-operative patients approving the trial.

Inclusion Criteria of teeth:

Class I deep caries lesions in permanent molar (reaching ≥ 1/2 of the dentin on radiographic examination).
Absence of spontaneous pain; negative sensitivity to percussion; and absence of periapical lesions (radiographic examination).

Exclusion Criteria:

Exclusion criteria of participants:

Pregnancy.
Systemic disease or severe medical complications.
Heavy smoking.
Xerostomia.
Lack of compliance.

Exclusion criteria of teeth:

Class II caries lesion.
Shallow or enamel caries.
Cuspal loss or caries beneath the gingival margin.
Intervention: Ibuprofen
Trial phase: Phase 2
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: 200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks.

Ibuprofen: 200 mg BID and 8 hours apart
Eligibility criteria:
Inclusion Criteria:

Have a diagnosis of cancer and have had surgery and are now receiving adjuvant or neoadjuvant chemotherapy or who have received chemotherapy within the last 6 months; chemotherapy with concurrent radiation therapy (RT) is allowed

Answer YES to the question: "Have you noticed any problems in your memory, attention, concentration, multi-tasking or other cognitive functions?" any time after initiation of chemotherapy cycle 1

NOTE: If a participant answers NO, they may be re-approached at a subsequent cycle
Be able to swallow medication
Be able to read English
Have the ability to understand and to give written informed consent as assessed by the participant's primary care physician or medical oncologist

Exclusion Criteria:

Have a confirmed brain tumor or brain metastases
Be taking a regular daily dose of an NSAID NOTE: Daily doses of 81 mg aspirin are permitted and higher doses of an NSAID on an 'as needed' basis are permitted
Be diagnosed with dementia or severe neurodegenerative disease
Have a contraindication to NSAIDs at the oncologist's discretion (i.e., allergy, worsening of ongoing medical problem due to NSAID, very low platelet count from chemotherapy, full-dose anti-coagulation/high risk of bleeding, and uncontrolled conditions such as hypertension, asthma, or peptic ulcer disease)
Have been hospitalized for treatment of a major psychiatric illness within the last five years
Have a serum creatinine above 1.5 upper limit of normal (ULN) (collected within the past 4 weeks); ULN is per institutional definition
Concurrent administration of warfarin, full dose aspirin, clopidogrel, apixaban or other medications known to increase the risk of bleeding or to interfere with antiplatelet activities
Be colorblind
Have active substance abuse (e.g. alcohol, drugs) per self-report or medical record
Intervention: Olanzapine
Trial phase: Phase 3
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 215
Group description: Coated bilayer tablet

Olanzapine: Daily oral dosing
Eligibility criteria:
Inclusion Criteria:

Has less than 24 weeks previous treatment with antipsychotics (cumulative; lifetime)

Subject treated with aripiprazole can receive an additional 1 year of treatment at ≤5 mg/day, and this treatment will not be considered as part of the 24 weeks of previous treatment with antipsychotics
Has less than 4 years elapse since the initial onset of active-phase of symptoms
Has a body mass index (BMI) of <30 kg/m^2
Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after the last dose of study drug
Subject meets the criteria for a primary diagnosis of schizophrenia, schizophreniform disorder, or bipolar I disorder
For bipolar I disorder, must have been experiencing an episode of acute mania within ≤14 days prior to Visit 1
Suitable for outpatient treatment
Additional criteria may apply

Exclusion Criteria:

Poses a current suicide risk
Has a history of poor or inadequate response to treatment with olanzapine
Has previously been treated with long-acting injectable antipsychotic medication within the 2 months prior to screening, or has > 6 months cumulative life use, or has received treatment with electroconvulsive therapy in their lifetime
Has initiated treatment with mood stabilizers (eg lithium, valproate, etc) >2 months prior to Visit 1
Has a positive drug screen for opioids, phencyclidine (PCP), amphetamine/methamphetamine, or cocaine
Has taken opioid agonists (eg, codeine, oxycodone, tramadol, morphine) within the 14 days prior to Visit 1, or has taken opioid antagonists, including naltrexone and naloxone, within 60 days prior to Visit 1
Taking any weight loss agents or hypoglycemic agents
Has a clinically significant or unstable medical illness, condition, or disorder that would be anticipated to potentially compromise subject safety or adversely affect the evaluation of efficacy
Has joined a weight management program or had significant changes in diet or exercise regimen within the past 6 weeks
Has started a smoking cessation program within the past 6 months
Has a history of diabetes
Currently pregnant or breastfeeding or is planning to become pregnant during the study or within 30 days of the last study drug administration
Additional criteria may apply
Intervention: Zanubrutinib
Trial phase: Phase 1
ATC code: L01EL03
SMILES: C=CC(=O)N1CCC([C@@H]2CCNc3c(C(N)=O)c(-c4ccc(Oc5ccccc5)cc4)nn32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Safety Evaluation: The participants in this dose regimen received zanubrutinib 320 mg daily (160 mg BID, administered in the morning and at night) and a "3+3" design was adopted for Part I of the study to determine RP2D.
Eligibility criteria:
Key Inclusion Criteria:

Men and women between the age of 18-75 years.
Participants with B-cell lymphoma (defined by World Health Organization classification) refractory or relapsed following at least one line of therapy.
Judged by the investigator as requiring treatment.
Eastern Cooperative Oncology Group performance status of 0-1.
Life expectancy of at least 4 months.
Adequate hematological function.
Adequate renal function.
Adequate liver function.
Adequate coagulation function.
Female participants of childbearing potential and non-sterile males must have practiced at least one of the following methods of birth control with partner(s) throughout the study and for 90 days after discontinuing study drug: total abstinence from sexual intercourse, double-barrier contraception, intrauterine device or hormonal contraceptive initiated at least 3 months prior to first dose of study drug.
Male participants must not have donated sperm from start of study drug administration, until 90 days after discontinuation of treatment.

Key Exclusion Criteria:

With central nervous system involvement of the disease.
The pathological type of the disease had disease transformation.
Had underdone allogeneic hematopoietic stem cell transplantation.
Had received corticosteroid anti-neoplastic treatment within 7 days before the first dose, has received radiotherapy and chemotherapy within 4 weeks before the first dose or has received treatment with monoclonal antibody within 4 weeks before the first dose.
Had received BTK inhibitor treatment prior to enrollment.
Had received chemotherapy and has not yet recovered from toxicity
Had received Chinese herbal medicine as anti-neoplastic therapy within 4 weeks before starting study treatment.
History of other malignancies within 2 years before study.
With uncontrolled systemic infection.
Major surgery in the past 4 weeks.
With known HIV, or active hepatitis B or hepatitis C virus infection.
With cardiovascular disease of New York Heart Association Classification ≥ 3.
Significant electrocardiogram abnormalities.
Significant active renal, neurologic, psychiatric, hepatic or endocrinologic disease that in the investigator's opinion would adversely impact on his/her participation in the study.
Inability to comply with study procedures.
Was currently taking anticoagulant drugs.
Was currently taking potent cytochrome P450 3A inhibitor or inducer.
Had stroke or cerebral hemorrhage within 6 months before enrollment.

Note: Other protocol defined Inclusion/Exclusion criteria may have applied.
Intervention: Zanubrutinib
Trial phase: Phase 1
ATC code: L01EL03
SMILES: C=CC(=O)N1CCC([C@@H]2CCNc3c(C(N)=O)c(-c4ccc(Oc5ccccc5)cc4)nn32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Safety Evaluation: The participants in this dose regimen received zanubrutinib 320 mg daily (320 mg QD) and a "3+3" design was adopted for Part I of the study to determine RP2D.
Eligibility criteria:
Key Inclusion Criteria:

Men and women between the age of 18-75 years.
Participants with B-cell lymphoma (defined by World Health Organization classification) refractory or relapsed following at least one line of therapy.
Judged by the investigator as requiring treatment.
Eastern Cooperative Oncology Group performance status of 0-1.
Life expectancy of at least 4 months.
Adequate hematological function.
Adequate renal function.
Adequate liver function.
Adequate coagulation function.
Female participants of childbearing potential and non-sterile males must have practiced at least one of the following methods of birth control with partner(s) throughout the study and for 90 days after discontinuing study drug: total abstinence from sexual intercourse, double-barrier contraception, intrauterine device or hormonal contraceptive initiated at least 3 months prior to first dose of study drug.
Male participants must not have donated sperm from start of study drug administration, until 90 days after discontinuation of treatment.

Key Exclusion Criteria:

With central nervous system involvement of the disease.
The pathological type of the disease had disease transformation.
Had underdone allogeneic hematopoietic stem cell transplantation.
Had received corticosteroid anti-neoplastic treatment within 7 days before the first dose, has received radiotherapy and chemotherapy within 4 weeks before the first dose or has received treatment with monoclonal antibody within 4 weeks before the first dose.
Had received BTK inhibitor treatment prior to enrollment.
Had received chemotherapy and has not yet recovered from toxicity
Had received Chinese herbal medicine as anti-neoplastic therapy within 4 weeks before starting study treatment.
History of other malignancies within 2 years before study.
With uncontrolled systemic infection.
Major surgery in the past 4 weeks.
With known HIV, or active hepatitis B or hepatitis C virus infection.
With cardiovascular disease of New York Heart Association Classification ≥ 3.
Significant electrocardiogram abnormalities.
Significant active renal, neurologic, psychiatric, hepatic or endocrinologic disease that in the investigator's opinion would adversely impact on his/her participation in the study.
Inability to comply with study procedures.
Was currently taking anticoagulant drugs.
Was currently taking potent cytochrome P450 3A inhibitor or inducer.
Had stroke or cerebral hemorrhage within 6 months before enrollment.

Note: Other protocol defined Inclusion/Exclusion criteria may have applied.
Intervention: Zanubrutinib
Trial phase: Phase 1
ATC code: L01EL03
SMILES: C=CC(=O)N1CCC([C@@H]2CCNc3c(C(N)=O)c(-c4ccc(Oc5ccccc5)cc4)nn32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Dose Expansion: The RP2D determined in Part I was used in Part II to further evaluate the preliminary anti-tumor effects of zanubrutinib in Chinese participants with FL or MZL.
Eligibility criteria:
Key Inclusion Criteria:

Men and women between the age of 18-75 years.
Participants with B-cell lymphoma (defined by World Health Organization classification) refractory or relapsed following at least one line of therapy.
Judged by the investigator as requiring treatment.
Eastern Cooperative Oncology Group performance status of 0-1.
Life expectancy of at least 4 months.
Adequate hematological function.
Adequate renal function.
Adequate liver function.
Adequate coagulation function.
Female participants of childbearing potential and non-sterile males must have practiced at least one of the following methods of birth control with partner(s) throughout the study and for 90 days after discontinuing study drug: total abstinence from sexual intercourse, double-barrier contraception, intrauterine device or hormonal contraceptive initiated at least 3 months prior to first dose of study drug.
Male participants must not have donated sperm from start of study drug administration, until 90 days after discontinuation of treatment.

Key Exclusion Criteria:

With central nervous system involvement of the disease.
The pathological type of the disease had disease transformation.
Had underdone allogeneic hematopoietic stem cell transplantation.
Had received corticosteroid anti-neoplastic treatment within 7 days before the first dose, has received radiotherapy and chemotherapy within 4 weeks before the first dose or has received treatment with monoclonal antibody within 4 weeks before the first dose.
Had received BTK inhibitor treatment prior to enrollment.
Had received chemotherapy and has not yet recovered from toxicity
Had received Chinese herbal medicine as anti-neoplastic therapy within 4 weeks before starting study treatment.
History of other malignancies within 2 years before study.
With uncontrolled systemic infection.
Major surgery in the past 4 weeks.
With known HIV, or active hepatitis B or hepatitis C virus infection.
With cardiovascular disease of New York Heart Association Classification ≥ 3.
Significant electrocardiogram abnormalities.
Significant active renal, neurologic, psychiatric, hepatic or endocrinologic disease that in the investigator's opinion would adversely impact on his/her participation in the study.
Inability to comply with study procedures.
Was currently taking anticoagulant drugs.
Was currently taking potent cytochrome P450 3A inhibitor or inducer.
Had stroke or cerebral hemorrhage within 6 months before enrollment.

Note: Other protocol defined Inclusion/Exclusion criteria may have applied.
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 158
Group description: ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 16 days.
Eligibility criteria:
Inclusion Criteria:

Are at least 17 years of age
Are scheduled for uncomplicated unilateral cataract surgery
Signature of the subject or parent(s) or legally authorized representative on the Informed Consent Form, and when appropriate the minor's assent in accordance with local regulations
Are willing and able to follow all instructions and attend all study visits
Are willing to avoid disallowed medication for the duration of the study
If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing (prior to enrollment and at the end of the study) and use effective contraception for the duration of the study
Male subjects whose female partners are not post-menopausal must agree to one of the following: 1) completely abstain from sexual intercourse, 2) use a barrier method (condoms) with spermicide during sexual intercourse for the duration of the study, 3) provide documentation for having had a vasectomy (with documented infertility)
Additional inclusion criteria also apply

Exclusion Criteria:

Have known sensitivity or poor tolerance to any component of the study drugs
Have any sign of iritis or scleritis in the study eye
Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye
Have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and likely to affect wound healing (e.g., diabetes mellitus, systemic connective tissue disease, severe atopic disease)
Have known blood dyscrasia or bone marrow suppression
Have any active corneal pathology in the study eye
Have had radial keratotomy, corneal transplant, or LASIK in the study eye within the last 2 years
Be currently pregnant, nursing, or planning a pregnancy; or have a positive urine pregnancy test
Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
Have a condition or a situation which, in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
Use of any medication the investigator feels may interfere with the study parameters
Additional exclusion criteria also apply
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 152
Group description: ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 16 days.
Eligibility criteria:
Inclusion Criteria:

Are at least 17 years of age
Are scheduled for uncomplicated unilateral cataract surgery
Signature of the subject or parent(s) or legally authorized representative on the Informed Consent Form, and when appropriate the minor's assent in accordance with local regulations
Are willing and able to follow all instructions and attend all study visits
Are willing to avoid disallowed medication for the duration of the study
If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing (prior to enrollment and at the end of the study) and use effective contraception for the duration of the study
Male subjects whose female partners are not post-menopausal must agree to one of the following: 1) completely abstain from sexual intercourse, 2) use a barrier method (condoms) with spermicide during sexual intercourse for the duration of the study, 3) provide documentation for having had a vasectomy (with documented infertility)
Additional inclusion criteria also apply

Exclusion Criteria:

Have known sensitivity or poor tolerance to any component of the study drugs
Have any sign of iritis or scleritis in the study eye
Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye
Have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and likely to affect wound healing (e.g., diabetes mellitus, systemic connective tissue disease, severe atopic disease)
Have known blood dyscrasia or bone marrow suppression
Have any active corneal pathology in the study eye
Have had radial keratotomy, corneal transplant, or LASIK in the study eye within the last 2 years
Be currently pregnant, nursing, or planning a pregnancy; or have a positive urine pregnancy test
Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
Have a condition or a situation which, in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
Use of any medication the investigator feels may interfere with the study parameters
Additional exclusion criteria also apply
Intervention: Brimonidine
Trial phase: Phase 4
ATC code: D11AX21 | S01EA05 | S01GA07
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy

Brimonidine 0.2%: 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy
Eligibility criteria:
Inclusion Criteria:

patients scheduled to undergo laser posterior capsulotomy due to posterior capsule opacification (PCO) after uneventful phacoemulsification cataract extraction with implantation of posterior chamber intraocular lenses (IOL/PC).

Exclusion Criteria:

baseline IOP greater than 21mmHg
glaucomatous eyes, already under treatment with anti glaucomatic medications
intraocular surgery except for uncomplicated cataract surgery
previous photorefractive surgery
active ocular inflammation or infection
patients under systemic administration of medications known to affect IOP
patients with severe respiratory or cardiovascular disease
pregnant or breast feeding women, and individuals with known hypersensitivity or contraindication for administration of the medications tested
a measurement of IOP > 30 mmHg at any time point of the study, or an increase from baseline >20 mmHg