anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Calcitriol
Trial phase: Phase 2
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Calcitriol 45mcg/week

Calcitriol: In pill form, 45 micrograms once a week for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Must be female.
Must have pathologically confirmed incident, primary invasive breast cancer.
Must be awaiting surgical resection.
Women of child-bearing potential (i.e. women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device (IUD), or double barrier device) and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Contraceptive use needs to be continued at least 1 month after the trial has ended.
Must provide informed consent.
Must be willing to discontinue use of calcium and/or vitamin D supplements other than multivitamin supplementation.
Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of < 10.2mg/dl.

Exclusion Criteria:

Subjects with life-threatening conditions that would preclude them from breast cancer treatment including: chronic cardiac failure, which is unstable despite medication use; uncontrolled hypertension; uncontrolled diabetes mellitus; or unstable coronary artery disease.
Patients with severe metabolic disorders, which includes phenylketonuria (PKU), homocystinuria, and Fabry's disease, that would preclude them from taking calcitriol.
Patients with a previous history of any other cancer except non-melanomous skin cancer within the past 5 years.
Patients with impaired renal function (CRCL < 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years.
Patients with hypercalcemia (corrected serum CA > 10.2 mg/dl) or a history of hypercalcemia or vitamin D toxicity.
Patients currently taking calcium supplements or aluminum-based antacids must immediately discontinue their use if they are to enroll in the study.
Patients currently taking vitamin D supplements must immediately discontinue their use if they are to enroll in the study.
Patients with a known sensitivity to calcitriol.
Women who are pregnant or lactating.
Women on antiresorptive drugs (e.g. bisphosphonates) within the past year.
Women currently using oral contraception.
Women with malabsorptive syndromes (i.e. cystic fibrosis, chronic pancreatitis) or taking medications that decrease the absorption of fat soluble vitamins (i.e. Orlistat, Questran).
Participants assigned to calcitriol who are routinely taking a multivitamin supplement may continue the supplement as long as the amount of vitamin D in the supplement is not in excess of the RDA (recommended daily allowance) of 400 IU or 10 μg. If they are not taking a multivitamin supplement, they will be asked to not start supplementation while on study.
Intervention: Ziprasidone
Trial phase: Phase 4
ATC code: N05AE04
SMILES: O=C1Cc2cc(CCN3CCN(c4nsc5ccccc45)CC3)c(Cl)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.

There was only one group for this study.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Type I or II BD for at least 6 months (confirmed with MINI)
On maintenance evidence-based treatment for BD (lithium, antipsychotic, anticonvulsant)
Have weight gain concerns that individual believes are related to BD medication treatment
Sub-optimal adherence as measured by the Tablet Routines Questionnaire (TRQ) and which the patient feels is related to weight gain concerns. TRQ threshold will be defined as missing an average of 20% or more of all prescribed BD treatment in the last week or month or missing 20% or more of the "offending agent" in the last week or last month. This is consistent with methodologies in PIs previous BD adherence studies

Exclusion Criteria:

Known resistance or intolerance to ziprasidone
Medical contraindication to ziprasidone
Individuals on ziprasidone immediately prior to study enrollment
Prior or current treatment with clozapine
Diagnosis of eating disorder
Individuals whose sub-optimal adherence is related to inability to pay for BD medication treatment or inability to arrange transportation to BD treatment clinical visits
Concurrent medical condition or psychiatric illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial
Current substance dependence
High risk of harm to self or others
Female who is currently pregnant or breastfeeding
Intervention: Bupivacaine
Trial phase: Not Applicable
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 2
Group description: this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively

Marcaine: 0.75 cc/kg of 1/4% Marcaine
Eligibility criteria:
Inclusion Criteria:

A child with a femoral shaft fracture requiring surgical treatment and the placement of intramedullary nails
Weight of 30-100 Kg
Child must be older than 6 years old

Exclusion Criteria:

Any child that had an open fracture
A child that has a pain abnormality
Any child with an allergy to local anesthetic
Any child with a neurological injury
Any child with the inability to report pain
Any child that is unable to use a PCA post-operatively
Intervention: Bupivacaine
Trial phase: Not Applicable
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 2
Group description: patient will receive hematoma block during surgery

Marcaine: 0.75 cc/kg of 1/4% Marcaine
Eligibility criteria:
Inclusion Criteria:

A child with a femoral shaft fracture requiring surgical treatment and the placement of intramedullary nails
Weight of 30-100 Kg
Child must be older than 6 years old

Exclusion Criteria:

Any child that had an open fracture
A child that has a pain abnormality
Any child with an allergy to local anesthetic
Any child with a neurological injury
Any child with the inability to report pain
Any child that is unable to use a PCA post-operatively
Intervention: Dapagliflozin
Trial phase: Phase 3
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 86
Group description: Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
Eligibility criteria:
Inclusion Criteria:

Provision of informed consent prior to any study specific procedures
Men or women age ≥20 years old (Either gender needs to be 40% or higher of total number of treated subjects)diagnosed with type 2 DM ; ≥6.5% and ≤10% at 1 week before randomization

Exclusion Criteria:

Type 1 diabetes mellitus
FPG >240 mg/dL before randomization
Subjects who have history of unstable or rapidly progressing renal disease
Subjects who have severe hepatic insufficiency and/or significant abnormal liver function
Significant cardiovascular history
Intervention: Dapagliflozin
Trial phase: Phase 3
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 88
Group description: Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
Eligibility criteria:
Inclusion Criteria:

Provision of informed consent prior to any study specific procedures
Men or women age ≥20 years old (Either gender needs to be 40% or higher of total number of treated subjects)diagnosed with type 2 DM ; ≥6.5% and ≤10% at 1 week before randomization

Exclusion Criteria:

Type 1 diabetes mellitus
FPG >240 mg/dL before randomization
Subjects who have history of unstable or rapidly progressing renal disease
Subjects who have severe hepatic insufficiency and/or significant abnormal liver function
Significant cardiovascular history
Intervention: Tiotropium
Trial phase: Phase 3
ATC code: R03AL06 | R03AL10 | R03BB04 | R03BB54
SMILES: [H][C@]1(OC(=O)C(O)(c2cccs2)c2cccs2)C[C@@]2([H])[C@]3([H])O[C@]3([H])[C@@]([H])(C1)[N+]2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 83
Group description: Tiotropium delivered once daily via HandiHaler® device.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) stage II or stage III according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines (2009)
Qualifying spirometry, Forced Expiratory Volume in one second (FEV1) and post-bronchodilator FEV1/FVC (Forced Vital capacity)
Smoking history ≥ 10 pack years

Exclusion Criteria:

Pregnant women or nursing mothers or women of child-bearing potential not using adequate contraception
Cardiac abnormality
History of asthma
Contraindications to cardiopulmonary exercise testing
Participation in active phase of pulmonary rehabilitation program
History of cancer within the past 5 years

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Preladenant
Trial phase: Phase 2
SMILES: COCCOc1ccc(N2CCN(CCn3ncc4c3nc(N)n3nc(-c5ccco5)nc43)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 111
Group description: Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Must have a diagnosis of idiopathic PD based on the United Kingdom Parkinson's Disease Society Brain Bank Criteria, judged to be moderate to severe
Must have received prior therapy with L-dopa for more than 1 year before Screening
Must have been on a stable, optimal dopaminergic treatment regimen, defined as maximum

therapeutic effect achieved with available anti-Parkinsonian treatment, for at least the 4 weeks immediately before randomization

If receiving one or more of the following adjunctive treatments: amantadine, anticholinergics, catechol-O-methyltransferase inhibitors, dopa decarboxylase inhibitors, dopamine agonists, entacapone, L-dopa, must have been on a stable regimen of treatment for at least the 4 weeks immediately before randomization
Hoehn and Yahr stage must be ≥ 2.5 and ≤ 4 following optimum titration of treatment medications at Screening
Must be experiencing motor fluctuations with or without dyskinesias following optimum titration of

treatment medications and within the 4 weeks immediately before Screening

- Must be experiencing a minimum of 2 hours/day of "off" time as estimated by the investigator

and supported by the symptom diary (Daily Diary) at the Diary Training Visit

- With or without the help of a caregiver, must be capable of maintaining an accurate and

complete symptom diary (Daily Diary) as assessed at the Diary Training Visit

- Must have results of Screening clinical laboratory tests (complete blood count [CBC], blood

chemistries, and urinalysis) within normal limits or clinically acceptable to the investigator at Screening

- Must have results of a physical examination within normal limits or clinically acceptable limits

to the investigator

Must be able to adhere to dose and visit schedules
Females of child-bearing potential must have a negative serum pregnancy test (human chorionic

gonadotropin [hCG]) at Screening and must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for 2 weeks after stopping the medication

Exclusion Criteria:

Must not have a form of drug-induced or atypical parkinsonism, cognitive impairment, bipolar disorder, schizophrenia, or other psychotic disorder
Must not have had surgery for PD
Must not have an untreated major depressive disorder meeting Diagnostic and Statistical Manual

of Mental Disorders IV Text Revision (DSM-IV-TR) criteria

- Must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on

clinical interview

Must not have participated in any studies using preladenant
Must not have allergy/sensitivity to preladenant or any of its excipients
Must not have used any investigational drugs or participated in any other clinical trial within 90 days of Screening
Intervention: Preladenant
Trial phase: Phase 2
SMILES: COCCOc1ccc(N2CCN(CCn3ncc4c3nc(N)n3nc(-c5ccco5)nc43)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 113
Group description: Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Must have a diagnosis of idiopathic PD based on the United Kingdom Parkinson's Disease Society Brain Bank Criteria, judged to be moderate to severe
Must have received prior therapy with L-dopa for more than 1 year before Screening
Must have been on a stable, optimal dopaminergic treatment regimen, defined as maximum

therapeutic effect achieved with available anti-Parkinsonian treatment, for at least the 4 weeks immediately before randomization

If receiving one or more of the following adjunctive treatments: amantadine, anticholinergics, catechol-O-methyltransferase inhibitors, dopa decarboxylase inhibitors, dopamine agonists, entacapone, L-dopa, must have been on a stable regimen of treatment for at least the 4 weeks immediately before randomization
Hoehn and Yahr stage must be ≥ 2.5 and ≤ 4 following optimum titration of treatment medications at Screening
Must be experiencing motor fluctuations with or without dyskinesias following optimum titration of

treatment medications and within the 4 weeks immediately before Screening

- Must be experiencing a minimum of 2 hours/day of "off" time as estimated by the investigator

and supported by the symptom diary (Daily Diary) at the Diary Training Visit

- With or without the help of a caregiver, must be capable of maintaining an accurate and

complete symptom diary (Daily Diary) as assessed at the Diary Training Visit

- Must have results of Screening clinical laboratory tests (complete blood count [CBC], blood

chemistries, and urinalysis) within normal limits or clinically acceptable to the investigator at Screening

- Must have results of a physical examination within normal limits or clinically acceptable limits

to the investigator

Must be able to adhere to dose and visit schedules
Females of child-bearing potential must have a negative serum pregnancy test (human chorionic

gonadotropin [hCG]) at Screening and must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for 2 weeks after stopping the medication

Exclusion Criteria:

Must not have a form of drug-induced or atypical parkinsonism, cognitive impairment, bipolar disorder, schizophrenia, or other psychotic disorder
Must not have had surgery for PD
Must not have an untreated major depressive disorder meeting Diagnostic and Statistical Manual

of Mental Disorders IV Text Revision (DSM-IV-TR) criteria

- Must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on

clinical interview

Must not have participated in any studies using preladenant
Must not have allergy/sensitivity to preladenant or any of its excipients
Must not have used any investigational drugs or participated in any other clinical trial within 90 days of Screening
Intervention: Preladenant
Trial phase: Phase 2
SMILES: COCCOc1ccc(N2CCN(CCn3ncc4c3nc(N)n3nc(-c5ccco5)nc43)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 113
Group description: Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Must have a diagnosis of idiopathic PD based on the United Kingdom Parkinson's Disease Society Brain Bank Criteria, judged to be moderate to severe
Must have received prior therapy with L-dopa for more than 1 year before Screening
Must have been on a stable, optimal dopaminergic treatment regimen, defined as maximum

therapeutic effect achieved with available anti-Parkinsonian treatment, for at least the 4 weeks immediately before randomization

If receiving one or more of the following adjunctive treatments: amantadine, anticholinergics, catechol-O-methyltransferase inhibitors, dopa decarboxylase inhibitors, dopamine agonists, entacapone, L-dopa, must have been on a stable regimen of treatment for at least the 4 weeks immediately before randomization
Hoehn and Yahr stage must be ≥ 2.5 and ≤ 4 following optimum titration of treatment medications at Screening
Must be experiencing motor fluctuations with or without dyskinesias following optimum titration of

treatment medications and within the 4 weeks immediately before Screening

- Must be experiencing a minimum of 2 hours/day of "off" time as estimated by the investigator

and supported by the symptom diary (Daily Diary) at the Diary Training Visit

- With or without the help of a caregiver, must be capable of maintaining an accurate and

complete symptom diary (Daily Diary) as assessed at the Diary Training Visit

- Must have results of Screening clinical laboratory tests (complete blood count [CBC], blood

chemistries, and urinalysis) within normal limits or clinically acceptable to the investigator at Screening

- Must have results of a physical examination within normal limits or clinically acceptable limits

to the investigator

Must be able to adhere to dose and visit schedules
Females of child-bearing potential must have a negative serum pregnancy test (human chorionic

gonadotropin [hCG]) at Screening and must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for 2 weeks after stopping the medication

Exclusion Criteria:

Must not have a form of drug-induced or atypical parkinsonism, cognitive impairment, bipolar disorder, schizophrenia, or other psychotic disorder
Must not have had surgery for PD
Must not have an untreated major depressive disorder meeting Diagnostic and Statistical Manual

of Mental Disorders IV Text Revision (DSM-IV-TR) criteria

- Must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on

clinical interview

Must not have participated in any studies using preladenant
Must not have allergy/sensitivity to preladenant or any of its excipients
Must not have used any investigational drugs or participated in any other clinical trial within 90 days of Screening
Intervention: Moxifloxacin
Trial phase: Phase 4
ATC code: J01MA14 | S01AE07
SMILES: [H][C@@]12CCCN[C@]1([H])CN(c1c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c1OC)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 120
Group description: Subjects undergoing cataract surgery, randomized to the VIGAMOX group
Eligibility criteria:
Inclusion Criteria:

Man or woman 18 years of age or older.
Physically capable of instilling eye drop or have an appropriate person available to assist in administration of eye drops 4 times a day.
Scheduled for phacoemulsification with intraocular lens (IOL) implantation for the treatment of cataract.
Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and be medically cleared for surgery.
Willing to adhere to the prohibitions and restrictions specified in this protocol.
Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

Known allergy or contraindication to the test article(s) or their components.
Presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters.
Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.
History of any significant illness that could be expected to interfere with the study parameters. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.

Use of disallowed therapies (systemic or topical):

Fluoroquinolone anti-infective agents (systemic or topical) within 1 week of Visit 1 or anytime after Visit 1 for the duration of the study.
Use of contact lenses for one week prior to the study and for the duration of the study.
Received an experimental drug or used an experimental medical device within 10 days before the planned start of treatment.
Breast-feeding
Intervention: Besifloxacin
Trial phase: Phase 4
ATC code: S01AE08
SMILES: N[C@@H]1CCCCN(c2c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c2Cl)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 120
Group description: Subjects scheduled for cataract surgery, randomized to the Besivance group
Eligibility criteria:
Inclusion Criteria:

Man or woman 18 years of age or older.
Physically capable of instilling eye drop or have an appropriate person available to assist in administration of eye drops 4 times a day.
Scheduled for phacoemulsification with intraocular lens (IOL) implantation for the treatment of cataract.
Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and be medically cleared for surgery.
Willing to adhere to the prohibitions and restrictions specified in this protocol.
Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

Known allergy or contraindication to the test article(s) or their components.
Presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters.
Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.
History of any significant illness that could be expected to interfere with the study parameters. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.

Use of disallowed therapies (systemic or topical):

Fluoroquinolone anti-infective agents (systemic or topical) within 1 week of Visit 1 or anytime after Visit 1 for the duration of the study.
Use of contact lenses for one week prior to the study and for the duration of the study.
Received an experimental drug or used an experimental medical device within 10 days before the planned start of treatment.
Breast-feeding