anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Nilotinib
Trial phase: Phase 4
ATC code: L01EA03 | L01XE08
SMILES: Cc1cn(-c2cc(NC(=O)c3ccc(C)c(Nc4nccc(-c5cccnc5)n4)c3)cc(C(F)(F)F)c2)cn1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 57
Group description: Adult patients: ≤ 800mg/day; Pediatric patients: 230mg/m2 twice daily (BID) and ≤ 800mg/day
Eligibility criteria:
Inclusion Criteria:

-Patient is currently enrolled in a Novartis-sponsored, Oncology Clinical Development & Medical Affairs study receiving nilotinib and has fulfilled all their requirements in the parent study -Patient is currently benefiting from the treatment with nilotinib, as determined by the investigator -Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements -Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures -Written informed consent obtained prior to enrolling in roll-over study

Exclusion Criteria:

- Patient has been permanently discontinued from nilotinib treatment in the parent study due to unacceptable toxicity, non-compliance to study procedures, withdrawal of consent or any other reason - Patient has participated in a Novartis sponsored combination trial where nilotinib was dispensed in combination with another study medication and patient is still receiving combination therapy -Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval or inducing Torsade de Pointes and the treatment cannot be either safely discontinued at least one week prior to nilotinib treatment or switched to a different medication prior to start of nilotinib treatment and for the duration of the study -Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcG laboratory test. -Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 30 days after the final dose of nilotinib.
Intervention: Ketorolac Tromethamine
Trial phase: Phase 4
SMILES: NC(CO)(CO)CO.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril.

Intranasal Ketoralac: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery
Eligibility criteria:
Inclusion Criteria:

Ureteroscopic stone removal surgeries with stenting
Age ≥ 18 years and < 65 years
Stable patient with stable vital signs
Mentally competent and is able to understand consent form

Exclusion Criteria:

Unstable patients
Patients with multiple trauma sites
Patients with allergies to ketorolac or any of the components in the nasal spray preparation
Patients with active peptic ulcer disease
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
Renal disease or at risk for renal failure due to volume depletion
Pregnant or nursing mothers
Nasal abnormality or illness that could affect the absorption of intranasal medication (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute epistaxis, nasal polyp, nasal tumor)
Any other contraindication to the use of Sprix, or in whom use of Sprix would not be consistent with the approved package insert
Intervention: LOTEPREDNOL ETABONATE
Trial phase: Phase 1
ATC code: S01BA14
SMILES: [H][C@@]12CC[C@](OC(=O)OCC)(C(=O)OCCl)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.

LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2
Eligibility criteria:
Inclusion Criteria:

Subjects must be healthy volunteers with physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
Subjects must have a best-corrected visual acuity of 20/20 or better in each eye.
Subjects must have no active ocular disease or allergic conjunctivitis.
Subjects must have a Schirmer test (without anesthesia) of ≥ 10mm in 5 minutes.
Subjects must not be using any topical ocular medications or systemic medication other than acetaminophen.
Male subjects or female subjects who are not of childbearing potential. Female subjects are considered to not be of childbearing potential if they are postmenopausal for at least 12 months or permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy)

Exclusion Criteria:

Subjects having an intraocular pressure less than 5 mmHg or greater than 22 mmHg or any type of glaucoma.
Subjects with a history of ocular trauma, infection, or inflammation within the last 3 months.
Subjects having any contraindication to the use of, or known sensitivity or allergy to, the study drug(s) or their components.
Subjects wearing contact lenses on the day of Visit 2 and/or Visit 3 of the study
Subjects having, at the Investigator's discretion, the presence of any significant illness that could be expected to interfere with the study.
Intervention: OXYTOCIN
Trial phase: Not Applicable
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Pitocin: Labor induction using Pitocin
Eligibility criteria:
Inclusion Criteria:

PROM not in labor

Exclusion Criteria:

Contraindication to vaginal delivery
Contraindication to labor induction
Abnormal fetal heart-rate patterns
Maternal heart disease
Severe maternal hypertension
Pelvic structural abnormality
Intervention: Vibegron
Trial phase: Phase 1
ATC code: G04BD15
SMILES: [H][C@]1([C@H](O)c2ccccc2)CC[C@@H](Cc2ccc(NC(=O)[C@@H]3CCc4nccc(=O)n43)cc2)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Participants received a single oral dose of vibegron 100 mg on Day 1.
Eligibility criteria:
Inclusion Criteria

For both healthy participants and participants with hepatic insufficiency:

Continuous non-smokers who haven't used nicotine-containing products for at least 3 months prior to study drug administration
Body mass index (BMI) ≤39 kg/m^2
Good health based on medical history, physical examination, vital signs, laboratory safety tests, and electrocardiogram (ECG)
Females of childbearing potential must be sexually inactive for 14 days prior to study drug administration and throughout study or use acceptable birth control method
Females of non-childbearing potential must have undergone an acceptable sterilization procedure at least 6 months prior to Day 1 of study or be postmenopausal with amenorrhea for at least 1 year prior to Day 1
Non-vasectomized males must agree to use a condom with spermicide or abstain from sexual intercourse during the trial and for 3 months after study drug administration

For participants with hepatic insufficiency only:

Diagnosis of chronic, stable, hepatic insufficiency
For Part 1 Participants: Child-Pugh scale range from 7 to 9
For Part 2 Participants: Child-Pugh scale range from 5 to 6
Intervention: Pantoprazole
Trial phase: Phase 4
ATC code: A02BC02 | A02BD04 | A02BD11
SMILES: COc1ccnc(CS(=O)c2nc3ccc(OC(F)F)cc3[nH]2)c1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: Intravenous pantoprazole 40 mg flacon

Pantoprazole: 33 patients
Eligibility criteria:
Inclusion Criteria:

Epigastric pain
Older than 18 years old

Exclusion Criteria:

Diagnosed as cholecystitis, pancreatitis, myocardial infarction, etc.. at the end of the emergency deparment evaluation period.
Pregnancy
Patients with unstable vital signs
Patients used anti-acid, H2 receptor blockers and proton pomp inhibitors in the last one hour.
Allergy to H2 receptor blockers and proton pomp inhibitors.
Patients denied to give inform consent and who are illiterate
Intervention: Ranitidine
Trial phase: Phase 4
ATC code: A02BA02 | A02BA07
SMILES: CNC(=C[N+](=O)[O-])NCCSCc1ccc(CN(C)C)o1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: Intravenous ranitidine 50 mg

Ranitidine: 33 patients
Eligibility criteria:
Inclusion Criteria:

Epigastric pain
Older than 18 years old

Exclusion Criteria:

Diagnosed as cholecystitis, pancreatitis, myocardial infarction, etc.. at the end of the emergency deparment evaluation period.
Pregnancy
Patients with unstable vital signs
Patients used anti-acid, H2 receptor blockers and proton pomp inhibitors in the last one hour.
Allergy to H2 receptor blockers and proton pomp inhibitors.
Patients denied to give inform consent and who are illiterate
Intervention: Atomoxetine
Trial phase: Phase 2
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: The study drug target dose is Atomoxetine (ATM) 80 milligram (mg) per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily.

Atomoxetine: The study drug target dose is ATM 80mg per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily.
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of idiopathic PD according to the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria
Male or female subjects aged between 35 and 75 years, inclusive at the time of consent
Hoehn & Yahr Stage I-IV
Diagnosis of PD mild cognitive impairment (MCI), Montreal Cognitive Assessment (MoCa) score 21-25
Stable concomitant medications for 60 days

Exclusion Criteria:

Secondary parkinsonism or atypical parkinsonism, Prior Deep Brain Stimulation (DBS) or other brain surgery
PD Dementia; MoCA score <21
Presence of Psychosis, pregnancy, suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS) type 4 or 5 in past 3 months.
Current treatment with anticholinergics, monoamine oxidase (MAO) inhibitors or neuroleptics (including quetiapine)
Serious cardiac abnormalities, Narrow angle glaucoma, Pheochromocytoma, Bipolar Disorder
Liver Function Tests (LFTs) >1.5 X upper limit of normal value
Intervention: Cabozantinib
Trial phase: Phase 2
ATC code: L01EX07 | L01XE26
SMILES: COc1cc2nccc(Oc3ccc(NC(=O)C4(C(=O)Nc5ccc(F)cc5)CC4)cc3)c2cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically confirmed invasive breast cancer with stage IV disease
Primary tumor and/or metastasis must be ER-negative, PR-negative and HER2-negative
May have received 0-3 prior chemotherapeutic regimens for metastatic breast cancer. Must be off treatment for at least 21 days prior to enrollment
Must have discontinued all biologic therapy at least 14 days before enrollment
May have received prior radiation therapy in the early stage or metastatic setting, but must have completed treatment at least 14 days prior to enrollment
Must agree to use medically acceptable methods of contraception
Confirmed availability of formalin-fixed, paraffin-embedded tumor tissue
Able to swallow tablets

Exclusion Criteria:

Pregnant or breastfeeding
Received another investigational agent within 14 days prior to enrollment
Received prior c-Met inhibitor
Known brain metastases that are untreated, symptomatic or require therapy to control symptoms
Psychiatric illness or social situation that could limit ability to comply with study requirements
Require concomitant treatment in therapeutic doses with anticoagulants or antiplatelet agents
Diagnosis of another malignancy requiring systemic treatment within the last two years (except non-melanoma skin cancer or in-situ carcinoma of the cervix)
Known to be positive for HIV
Active infection requiring IV antibiotics at Day 1 of cycle 1
Uncontrolled, significant intercurrent illness
Requires chronic concomitant treatment of a strong CYP3A4 inducer
tumor in contact with, invading or encasing major blood vessels
Have experienced clinically significant gastrointestinal bleeding within 6 months, hemoptysis of more than 0.5 teaspoon of red blood within 3 months or other signs indicative of pulmonary hemorrhage within 3 months of enrollment
Intervention: NITROUS OXIDE
Trial phase: Phase 2
ATC code: N01AX13 | N01AX63
SMILES: [N-]=[N+]=O
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: Parturients who request labor analgesia will be offered inhaled nitrous oxide for labor analgesia.

Inhaled nitrous oxide: Administration of nitrous oxide for labor analgesia
Eligibility criteria:
Inclusion Criteria:

all women of childbearing age (including children aged 14 years and above)who are pregnant
parturients who request labor analgesia of family medicine investigators certified in the use of nitrous oxide for labor analgesia at Magee-Women's Hospital
informed verbal and written consent

Exclusion Criteria:

coexisting medical conditions that are contraindications to the use of nitrous oxide (i.e. recent eye or ear surgery, history of Meniere's disease, history of vitamin B-12 deficiency)
history of severe nausea and vomiting
history of chronic pain
inability to hold a facemask
impairment of consciousness or intoxication at time of delivery
received intravenous opioids within two hours prior to initiation of nitrous oxide
impaired oxygenation (ex: lung cysts, pneumothorax, pulmonary hypertension, or pulmonary edema) with a room-air pulse oximetry reading less than 95%
hemodynamic instability
non-reassuring fetal heart rate tracing
inability to read, write and understand the English language enough to complete all survey questionnaires and pain assessment scales.
Intervention: Lisdexamfetamine Dimesylate
Trial phase: Phase 3
SMILES: CC(Cc1ccccc1)NC(=O)C(N)CCCCN.CS(=O)(=O)O.CS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
Eligibility criteria:
Inclusion Criteria:

18 to 65 years of age
Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends >4 hours/week with the subject)
Fixed home/place of residence and can be reached by telephone
On a stable dose of antipsychotic medications
Able to swallow capsules

Exclusion Criteria:

Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products
Treated with clozapine in past 30 days
Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence
History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions
Uncontrolled hypertension
History of thyroid disorder that has not been stabilized on thyroid medication
Glaucoma
Pregnant or nursing
Subject has received an investigational product or participated in a clinical study within 30 day
Intervention: Lisdexamfetamine Dimesylate
Trial phase: Phase 3
SMILES: CC(Cc1ccccc1)NC(=O)C(N)CCCCN.CS(=O)(=O)O.CS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
Eligibility criteria:
Inclusion Criteria:

18 to 65 years of age
Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends >4 hours/week with the subject)
Fixed home/place of residence and can be reached by telephone
On a stable dose of antipsychotic medications
Able to swallow capsules

Exclusion Criteria:

Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products
Treated with clozapine in past 30 days
Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence
History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions
Uncontrolled hypertension
History of thyroid disorder that has not been stabilized on thyroid medication
Glaucoma
Pregnant or nursing
Subject has received an investigational product or participated in a clinical study within 30 day
Intervention: Lisdexamfetamine Dimesylate
Trial phase: Phase 3
SMILES: CC(Cc1ccccc1)NC(=O)C(N)CCCCN.CS(=O)(=O)O.CS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
Eligibility criteria:
Inclusion Criteria:

18 to 65 years of age
Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends >4 hours/week with the subject)
Fixed home/place of residence and can be reached by telephone
On a stable dose of antipsychotic medications
Able to swallow capsules

Exclusion Criteria:

Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products
Treated with clozapine in past 30 days
Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence
History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions
Uncontrolled hypertension
History of thyroid disorder that has not been stabilized on thyroid medication
Glaucoma
Pregnant or nursing
Subject has received an investigational product or participated in a clinical study within 30 day
Intervention: Acetylcysteine
Trial phase: Not Applicable
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: 1800 mg twice daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Capability to provide written informed consent
Age ≥ 40 years and ≤ 85 years
FEV1/FVC ratio (post bronchodilator) < 70%
FEV1 (post bronchodilator) < 65%
Presence of chronic cough and sputum production defined as the following:
Presence of chronic cough and sputum will be defined by responses to the first two questions on the SGRQ. Subjects who respond positively to both question 1 (cough) and question 2 (sputum) on the SGRQ as either "several days per week" or "almost every day" will be eligible
Current or former smoker with lifetime cigarette consumption of at least 10 pack-years
Negative serum pregnancy test at the baseline visit if patient is a pre-menopausal female (menopause defined as absence of a menstrual cycle in the last 12 months)
Must be fluent in speaking the English language

Exclusion Criteria:

Not fully recovered for at least 30 days from a COPD exacerbation characterized by typical symptoms and treated with antibiotics or prednisone
Known allergy or sensitivity to NAC or albuterol
Any patient with unstable cardiac disease
Any patient with a documented history of uncompensated congestive heart failure in the last 2 years
Clinical diagnosis of asthma, bronchiectasis, cystic fibrosis, or severe alpha-1 antitrypsin deficiency
Active lung cancer or history of lung cancer if it has been less than 2 years since lung resection or other treatment. If history of lung cancer, must have no evidence of recurrence in the 2 years preceding the baseline visit.
Undergoing active treatment for malignancy except for hormonal therapy (i.e. prostate cancer, breast cancer) or non-metastatic skin cancer and are not symptomatic
Chronic kidney disease with an estimated GFR of < 30 ml/min. GFR will be estimated using the Modification of Diet in Renal Disease (MDRD) formula
History of cirrhosis with evidence of portal hypertension (ascites, chronic edema)
Participation in a pulmonary rehabilitation program or completion within past 6 weeks
Prisoners or institutionalized patients
Participation in another study involving an investigational product within 30 days of the baseline visit
Pregnant or breast-feeding patients.
Use of guaifenesin in the last 30 days
Currently on long acting nitrates for angina or heart failure
Abnormalities in screening blood work defined as:
WBC < 3.0 or > 15.0 K/cmm
Hemoglobin < 9.0 or > 17.0 gm/dl
Platelets < 75 or > 400 K/cmm
ALT > 3 times the upper limit of normal
INR > 1.5 unless on warfarin therapy
Any concomitant condition that might endanger the patient through participation in the study or interfere with study procedures, as assessed by the investigator