anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: (3S)-3-methylsulfanyl-1-[2-[4-[4-(1-methyl-1,2,4-triazol-3-yl)phenyl]-3,6-dihydro-2H-pyridin-1-yl]-2-oxoethyl]-N-[3-(6-propan-2-yloxypyridin-3-yl)-1H-indazol-5-yl]pyrrolidine-3-carboxamide
Trial phase: Phase 1
SMILES: CSC1(C(=O)Nc2ccc3[nH]nc(-c4ccc(OC(C)C)nc4)c3c2)CCN(CC(=O)N2CC=C(c3ccc(-c4ncn(C)n4)cc3)CC2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Participants received 100 mg twice daily for 28 days during each cycle
Eligibility criteria:
Inclusion Criteria:

Pathologically/histologically confirmed solid tumor (metastatic or locally advanced disease) that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
Participants of childbearing potential must have negative pregnancy test; females and males must agree to use effective contraception during the course of the trial and for 90 days after stopping study drug.
For Part 1b and Part 2, participant with metastatic melanoma or metastatic colorectal cancer with at least one measurable lesion
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with a life expectancy of ≥3 months.
Adequate organ function.

Exclusion Criteria:

Unstable or progressing central nervous system (CNS) metastasis unless asymptomatic for 3 months, with no need for steroids or antiseizure medications.
Active gastrointestinal disease or a disorder or a history of surgery that significantly alters gastrointestinal motility or absorption.
Has not recovered from previous therapy and had any chemotherapy, biologic, or hormonal therapy within 4 weeks of study enrollment.
Radiation therapy (except palliative radiation to bone lesions) within 4 weeks of study enrollment.
More than 3 prior regimens of chemotherapy, biologic therapy, hormonal therapy, or investigational drugs not including adjuvant or neoadjuvant treatments.
Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic diseases.
Mean QTcF interval (interval on the electrocardiogram corrected for heart rate using Fridericia's correction) > 450 msec at baseline.
Known Human Immunodeficiency Virus (HIV) infection, hepatitis infection, or tuberculosis infection.
Current participation in any other interventional clinical study.
History of significant eye disease, including glaucoma, retinopathy, or retinal vein occlusion.
Intervention: Prasterone
Trial phase: Phase 3
ATC code: A14AA07 | G03EA03 | G03XX01
SMILES: [H][C@]1(O)CC[C@@]2(C)C(=CC[C@]3([H])[C@]2([H])CC[C@]2(C)C(=O)CC[C@@]32[H])C1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 143
Group description: DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
Eligibility criteria:
Inclusion Criteria:

Postmenopausal women (non-hysterectomized or hysterectomized)
Women between 40 and 75 years of age
Willing to participate in the study and sign an informed consent
Women who have self-identified symptom(s) of vaginal atrophy
For non-hysterectomized women, willing to have endometrial biopsy at baseline and end of study

Exclusion Criteria:

Undiagnosed abnormal genital bleeding
Hypertension equal to or above 140/90 mm Hg
The administration of any investigational drug within 30 days of screening visit
Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening
Intervention: Tofacitinib
Trial phase: Phase 2
ATC code: L04AA29
SMILES: C[C@@H]1CCN(C(=O)CC#N)C[C@@H]1N(C)c1ncnc2[nH]ccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 112
Group description: CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
Eligibility criteria:
Inclusion Criteria:

The subject must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of RA by satisfying at least four of the seven criteria.
The subject must have active disease at both screening and baseline

Exclusion Criteria:

History of any documented influenza or pneumococcal infection within the last 3 months.
Receipt of any vaccine within 1 month prior to the initial study drug administration (CP-690,550 or placebo CP-690,550).
If a subject has received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of initial study drug administration.
Intervention: Clonidine
Trial phase: Phase 2 | Phase 3
ATC code: C02AC01 | C02LC01 | C02LC51 | N02CX02 | S01EA04
SMILES: Clc1cccc(Cl)c1NC1=NCCN1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 12
Group description: Infants will receive intravenous or oral clonidine(Duraclon) for the treatment of pain and sedation

Clonidine HCL: At day 5 on opioid and/or benzodiazepine (BZD), the infant will be randomized to receive either placebo (normal saline) or clonidine 1μg/kg/q 4 hrs to a maximum dose of 2μg/kg/q 4. Weaning from the study drug: When the opioid is no longer required, 24 hrs later the study drug (placebo or study drug) will be reduced by 50% and then discontinued 24 hours later provided that the Modified Finnegan scores remain between < 9.
Eligibility criteria:
Inclusion Criteria:

>35 week Gestational Age (GA) at birth
<3 months (90 days) old chronological age at the time of enrollment
Exposed to a minimum five days of continuous narcotic infusion

Exclusion Criteria:

Neurologic abnormality which would make Neonatal Abstinence Score (NAS) scoring inaccurate
Major chromosomal abnormality (with the exception of Trisomy 21)
Infant already enrolled in another randomized, controlled clinical trial
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2 | Phase 3
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 12
Group description: Infants will receive place (saline) (if receiving it IV) or orally (sterile water) if receiving it orally

saline: Infants randomized to placebo will be administered IV saline or oral sterile water in the same volume as study drug. The placebo will be give every 4 hrs as outlined in the algorithm for the study.
Eligibility criteria:
Inclusion Criteria:

>35 week Gestational Age (GA) at birth
<3 months (90 days) old chronological age at the time of enrollment
Exposed to a minimum five days of continuous narcotic infusion

Exclusion Criteria:

Neurologic abnormality which would make Neonatal Abstinence Score (NAS) scoring inaccurate
Major chromosomal abnormality (with the exception of Trisomy 21)
Infant already enrolled in another randomized, controlled clinical trial
Intervention: Metronidazole
Trial phase: Phase 2
ATC code: A01AB17 | A02BD01 | A02BD02 | A02BD03 | A02BD08 | A02BD11 | A02BD13 | A02BD15 | D06BX01 | G01AF01 | G01AF20 | J01RA03 | J01RA04 | J01RA10 | J01RA14 | J01XD01 | P01AB01 | P01AB51 | P01AB52
SMILES: Cc1ncc([N+](=O)[O-])n1CCO
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: control arm
Eligibility criteria:
Inclusion Criteria:

presence of trichomonas

Exclusion Criteria:

pregnant or nursing
known immunodeficiency
allergy to study drugs
concurrent yeast infection
history of seizures or peripheral neuropathy
unwillingness to abstain from alcohol during treatment period and for 48 hrs after concurrent lithium
anticoagulation therapy, and abuse
patient expected to have menses within 8 days of enrollment
Intervention: Paroxetine Mesylate
Trial phase: Phase 3
SMILES: CS(=O)(=O)O.Fc1ccc(C2CCNCC2COc2ccc3c(c2)OCO3)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 301
Group description: Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
Eligibility criteria:
Inclusion Criteria:

Female, ≥ 40 years of age at screening (inclusive)
Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60 moderate to severe hot flashes per week for at least 30 days prior to the screening visit
Spontaneous amenorrhea for at least 12 consecutive months or
Amenorrhea for at least 6 months and meet the biochemical criteria for menopause or
Bilateral salpingo-oophorectomy ≥ 6 weeks with or without hysterectomy

Exclusion Criteria:

Known non-responder to previous Selective serotonin reuptake inhibitor (SSRI) or Serotonin norepinephrine reuptake inhibitor (SNRI) treatment for VMS
History of self injurious behavior
History of clinical diagnosis of depression or treatment for depression
History of clinical diagnosis of borderline personality disorder
Use of an investigational study medication within 30 days prior to screening or during the study
Concurrent participation in another clinical trial or previous participation in this trial
Family of investigational-site staff
Intervention: Nabiximols
Trial phase: Phase 3
ATC code: N02BG10
SMILES: C=C(C)C1CCC(C)=CC1c1c(O)cc(CCCCC)cc1O.CCCCCc1cc(O)c2c(c1)OC(C)(C)C1CCC(C)=CC21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 199
Group description: Nabiximols was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day, for 5 weeks. Nabiximols oromucosal spray contained THC (27 mg/mL):CBD (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD.
Eligibility criteria:
Inclusion Criteria (abbreviated):

The participant had advanced cancer for which there was no known curative therapy
The participant had a clinical diagnosis of cancer related pain, which was not wholly alleviated with their current optimized opioid treatment
The participant received an optimized maintenance dose of Step 3 opioid therapy, preferably with a sustained release preparation, but also allowing a regular maintenance dose of around-the-clock use of immediate release preparations
The participant received a daily maintenance dose Step 3 opioid therapy of less than or equal to a total daily opioid dose of 500 mg/day of morphine equivalence (including maintenance and break-through opioids)
The participant was using no more than one type of break-through opioid analgesia

Exclusion Criteria (abbreviated):

The participant had any planned clinical interventions that would have affected their pain (for example, chemotherapy or radiation therapy where, in the clinical judgment of the investigator, these would be expected to affect pain)
The participant was using or had used cannabis or cannabinoid-based medications within 30 days of study entry and is unwilling to abstain for the duration of the study
The participant had experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or had a cardiac disorder that, in the opinion of the investigator, would have put the participant at risk of a clinically significant arrhythmia or myocardial infarction
The participant had significantly impaired renal function
The participant had significantly impaired hepatic function
Female participants of child-bearing potential and male participants whose partner was of child-bearing potential, unless willing to ensure that they or their partner used effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for 3 months thereafter (however, a male condom was not to be used in conjunction with a female condom as this may not have proven effective)
Intervention: ASPIRIN
Trial phase: Not Applicable
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 190
Group description: All subjects took 7-10 days of 81 mg aspirin
Eligibility criteria:
Inclusion Criteria:

Volunteers 40 to 80 years old willing to sign consent and take 81 mg of aspirin for 7 - 10 days and return for laboratory testing.

Exclusion Criteria:

Patient requiring more than 81 mg aspirin daily
Known GI bleeding attributed to ASA
Active peptic ulcer disease or history within the last year
Known aspirin allergy

Current use of:

warfarin,
heparin,
NSAIDs (except aspirin),
clopidogrel,
dipyridamole,
fish-oil/omega 3 supplements,
Women of childbearing potential who are pregnant, planning to become pregnant or nursing.
Intervention: Leucine
Trial phase: Phase 1 | Phase 2
SMILES: CC(C)CC(N)C(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: No alternative treatment arm

leucine: Dosage of leucine will be dependent on body surface area (BSA): leucine 700 mg/m2/dose by mouth three times a day
Eligibility criteria:
Inclusion Criteria:

diagnosed with Diamond Blackfan anemia as published in British Journal of Hematology
transfusion dependent
age 2 years and older
adequate renal function
adequate liver function
negative B-HCG if patient is a menstruating female and documentation of adequate contraception
signed informed consent

Exclusion Criteria:

Known hypersensitivity to branched chain amino acids
Diagnosis of an inborn error of amino acid metabolism disorder
Prior hematopoietic stem cell transplantation
Pregnancy, or plans to become pregnant during duration of trial
Intervention: Ketorolac Tromethamine
Trial phase: Phase 1
SMILES: NC(CO)(CO)CO.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 7
Group description: Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
Eligibility criteria:
Inclusion Criteria:

Children aged 12 through 17 years
Body weight > or = 30 kg and < or = 100 kg
Female subjects of childbearing potential must have a negative serum or urine pregnancy test result prior to entry into the study
A legal representative able to provide written informed consent
Willing and able to comply with all testing and requirements defined in the protocol
Willing and able to complete the posttreatment visit

Exclusion Criteria:

Allergy or sensitivity to ketorolac or ethylene diamine tetraacetic acid (EDTA)
Allergic reaction to aspirin or other NSAIDs
Had an upper respiratory tract infection or other respiratory tract condition (eg, active allergic rhinitis) that could interfere with the absorption of the nasal spray or with the assessment of AEs
Use of any IN product within 24 hours prior to study entry
Clinically significant abnormality on screening laboratory tests
History of cocaine use resulting in nasal mucosal damage
History of peptic ulcer disease or gastrointestinal bleeding
Had advanced renal impairment or a risk for renal failure due to volume depletion
A history of any other clinically significant medical problem, which in the opinion of the investigator would interfere with study participation
Participation within 30 days of study entry or within 5 times the half-life, whichever is longer, in another investigational drug study
Allergy or significant reaction to opioids
Was pregnant or breastfeeding
Previously participated in this study
The surgical procedure involved head, neck, oral, or nasal surgery
Intervention: Ketorolac Tromethamine
Trial phase: Phase 1
SMILES: NC(CO)(CO)CO.O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 13
Group description: Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
Eligibility criteria:
Inclusion Criteria:

Children aged 12 through 17 years
Body weight > or = 30 kg and < or = 100 kg
Female subjects of childbearing potential must have a negative serum or urine pregnancy test result prior to entry into the study
A legal representative able to provide written informed consent
Willing and able to comply with all testing and requirements defined in the protocol
Willing and able to complete the posttreatment visit

Exclusion Criteria:

Allergy or sensitivity to ketorolac or ethylene diamine tetraacetic acid (EDTA)
Allergic reaction to aspirin or other NSAIDs
Had an upper respiratory tract infection or other respiratory tract condition (eg, active allergic rhinitis) that could interfere with the absorption of the nasal spray or with the assessment of AEs
Use of any IN product within 24 hours prior to study entry
Clinically significant abnormality on screening laboratory tests
History of cocaine use resulting in nasal mucosal damage
History of peptic ulcer disease or gastrointestinal bleeding
Had advanced renal impairment or a risk for renal failure due to volume depletion
A history of any other clinically significant medical problem, which in the opinion of the investigator would interfere with study participation
Participation within 30 days of study entry or within 5 times the half-life, whichever is longer, in another investigational drug study
Allergy or significant reaction to opioids
Was pregnant or breastfeeding
Previously participated in this study
The surgical procedure involved head, neck, oral, or nasal surgery
Intervention: Molsidomine
Trial phase: Phase 4
ATC code: C01DX12
SMILES: CCOC([O-])=Nc1c[n+](N2CCOCC2)no1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Coruno (molsidomine 16 mg tablet; per os; once daily)

Coruno: Molsidomine 16 mg tablet, per os, once a day
Eligibility criteria:
Inclusion Criteria:

Aged at least 18 years.
No treatment with molsidomine and/or long-acting nitrates (oral or patches) for more than 48 hours during the month preceding percutaneous coronary intervention (PCI) and no treatment with these same drugs within 3 days before PCI.
Patients who the investigator believes that they and/or their Legally Acceptable Representative (LAR) can and will comply with the requirements of the protocol.
Written informed consent from the patient or from the LAR.
Patients who underwent PCI for stable angina pectoris one month prior to the start of the study.
Patients presenting endothelial dysfunction at Month 0 (score of the Endo-PAT <0.40).

Exclusion Criteria:

Pre-menopausal women.
Patient with a clinically-active malignancy.
Known major renal insufficiency or known significant hepatic insufficiency.
History of psychological disorder, mental dysfunction, alcohol or drug abuse or any other factor which might interfere with the ability to cooperate in the study.
Participation in another clinical trial which has not yet reached its primary endpoint or with the same primary endpoint during the previous month.
Concurrently participating in another clinical study, at any time during the study period, in which the subject will be exposed to an investigational or a non-investigational product (vaccine, drug or device).
Hypersensitivity to molsidomine or to one of its excipients.
Peri-procedural infarction: creatine kinase-muscle/brain (CK-MB) >3 times the upper reference limit.
Clinically significant abnormal pre-PCI CK-MB and troponin: any elevation above the upper reference limit.
Intolerance to galactose, deficiency in Lapp lactase or glucose-galactose malabsorption.
Left ventricular insufficiency (New York Heart Association [NYHA] class III or IV) with an ejection fraction <35%.
Acute circulatory insufficiency (e.g. cardiogenic shock).
Hypotension: systolic blood pressure <100 mmHg and/or diastolic blood pressure <70 mmHg.
Atrial fibrillation
Acute myocardial infarction during the preceding month.
Unsuccessful PCI: residual stenosis of at least 50%.
Patient taking phosphodiesterase-5 inhibitors, such as sildenafil (Viagra®), vardenafil (Levitra®) and tadalafil (Cialis®)
Patient taking nebivolol (Nobiten®)
Patient taking ibuprofen + L-arginine as excipient (Spidifen®)
Patient meeting any contraindication(s) from Coruno®. Please refer to Coruno® (molsidomine 16 mg o.d.)Summary of Product Characteristics (SPC).
Intervention: Epinastine Hydrochloride
Trial phase: Phase 3
SMILES: Cl.NC1=NCC2c3ccccc3Cc3ccccc3N12
Sex: All
Age groups: Child | Adult | Older Adult
Participants at risk: 130
Group description: DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
Eligibility criteria:
Inclusion Criteria:

Provided signed, written informed consent.
Has a positive result from a Type I allergy test.
If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

Exclusion Criteria:

Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
Presence of any abnormality or significant illness that could be expected to interfere with the study.
Intervention: Amifostine
Trial phase: Phase 3
ATC code: V03AF05
SMILES: NCCCNCCSP(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Amifostine and SRS

CyberKnife stereotactic radiosurgery and Amifostine
Eligibility criteria:
Inclusion Criteria:

All patients age 18 years and older with typical trigeminal neuralgia, as determined by diagnostic criteria set by the International Headache Society, who are:

Intolerant of or refractory to medical management; AND
Not candidates for or refusing a surgical micro-vascular decompression.

Exclusion Criteria:

Patients who present with pre-existing BNI grade III or IV facial numbness.
Patients who have previously been treated with MVD.
Patients who have previously had an ablative treatment, including prior SRS.
Pediatric patients (age <18), pregnant women, and patients who are unable to give informed consent will be excluded.
Intervention: Guaifenesin
Trial phase: Phase 2
ATC code: R05CA03
SMILES: COc1ccccc1OCC(O)CO
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Guaifenesin: Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
Eligibility criteria:
Inclusion Criteria:

Children between the ages of 7 and 18 years, diagnosed with Chronic Rhinitis and nasal stuffiness for at least 3 month duration.

Exclusion Criteria:

Children with immunodeficiency, cystic fibrosis, acute or subacute symptoms, signs of bacterial infection, and/or those who are unable to cooperate with testing will be excluded. Children with documented use of the study medication in the month before evaluation and during period of symptoms will also be excluded.