anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Clonidine
Trial phase: Phase 2
ATC code: C02AC01 | C02LC01 | C02LC51 | N02CX02 | S01EA04
SMILES: Clc1cccc(Cl)c1NC1=NCCN1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be continued to achieve control of NAS symptoms. Clonidine may be weaned after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine.

Clonidine: Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be increased by 1.5 mcg/kg/day to achieve control of NAS symptoms based upon standardized scoring for neonatal abstinence syndrome. Clonidine will be weaned by 25% every 24 hours after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine.
Eligibility criteria:
Inclusion Criteria:

Infants greater than or equal to 35 weeks gestation age
Admitted to the neonatal intensive care unit
Failed monotherapy with morphine sulfate therapy

Exclusion Criteria:

Neonatal abstinence syndrome due to iatrogenic causes
Unable to take oral medications at any point during their treatment
Infants in the custody of the Department of Child Protective Services with no legal guardian identified at the time of enrollment
Intervention: Lasmiditan
Trial phase: Phase 3
ATC code: N02CC08
SMILES: CN1CCC(C(=O)c2cccc(NC(=O)c3c(F)cc(F)cc3F)n2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 477
Group description: Participants initially received 100 mg Lasmiditan at the first OLE visit, with flexible dosing (50, 100, or 200 mg) thereafter to optimize efficacy and tolerability.
Eligibility criteria:
Inclusion Criteria:

Migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1
History of disabling migraine for at least 1 year
Migraine onset before the age of 50 years
History of 3 to 8 migraine attacks per month (<15 headache days per month) during the past 3 months
MIDAS score ≥11
Able and willing to complete an eDiary to record the details of each migraine attack treated with study drug
Women of child-bearing potential must be using or willing to use a highly effective form of contraception
Agree not to post any personal medical data or information related to the study on any website or social media site until the entire trial has completed

Exclusion Criteria:

Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets
History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the participant at increased risk of seizures
History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders
History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy)
History of orthostatic hypotension with syncope
Significant renal or hepatic impairment in the opinion of the investigator or if they meet hepatic monitoring criteria
Participants who, in the investigator's judgment, are actively suicidal and therefore deemed to be at significant risk for suicide
History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (eg, hemicranias continua, medication overuse headache where headache frequency is ≥15 headache days per month)
Use of more than 3 doses per month of either opioids or barbiturates
Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within 3 months prior to screening
Pregnant or breast-feeding women
History of drug or alcohol abuse/dependence within 1 year prior to screening
Any medical condition or clinical laboratory test which in the judgment of the investigator makes the participant unsuitable for the study
Currently enrolled in any other clinical study involving an investigational product
Relatives of, or staff directly reporting to, the Investigator
Participants who are employees of the sponsor
Intervention: Vancomycin
Trial phase: Phase 1 | Phase 2
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Vancomycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.

Vancomycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
Eligibility criteria:
Inclusion Criteria:

Male or female, between 18-80 years old, diagnosed with chronic rhinosinusitis who have undergone previous functional endoscopic sinus surgery including at minimum maxillary antrostomy and anterior ethmoidectomy
Active mucopurulence on endoscopic examination with corresponding culture demonstrating pathogenic bacterial growth
Completion of written informed consent
No prior enrollment into this study
Refractory to maximal medical therapy

Exclusion Criteria:

Patient has not had prior endoscopic sinus surgery consisting of at minimum maxillary antrostomy and anterior ethmoidectomy
Patient is currently being treated with oral antibiotics
Patient has been treated with oral or topical antibiotics within the past 14 days
Participation in an investigational drug study simultaneously with participation in this study
Concurrent use of oral steroids
Allergy to Tobramycin, Mupirocin, Gentamicin and Levofloxacin
Known to currently be pregnant
Intervention: Pyridostigmine Bromide
Trial phase: Phase 2
SMILES: CN(C)C(=O)Oc1ccc[n+](C)c1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Pyridostigmine 60 mg by mouth as a one time dose

Pyridostigmine Bromide: Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose
Eligibility criteria:
Inclusion Criteria:

Meets the Institute of Medicine (IOM) criteria for ME/CFS
Completing the clinically indicated invasive cardiopulmonary exercise test (iCPET)

Exclusion Criteria:

Obesity (BMI > 30 kg/m2)
Non-controlled asthma
Anemia (Hb < 10 g/dl)
Active or treated cancer
History of interstitial lung disease (ILD)
Chronic obstructive pulmonary disease (COPD)
Pulmonary hypertension (PH)
Congestive heart failure (CHF)
Active arrhythmias
Valvular heart disease
Coronary artery disease (CAD)
Other conditions that could predict a limitation or not completion of the study.
Pregnancy
Submaximal testing in clinically indicated iCPET
Pulmonary mechanical limitation to exercise in clinically indicated iCPET.
Pulmonary arterial hypertension in clinically indicated iCPET.
Pulmonary venous hypertension in clinically indicated iCPET.
Exercise induced pulmonary arterial hypertension in clinically indicated iCPET.
Exercise induced pulmonary venous hypertension in clinically indicated iCPET.
Persistent hypotension during or after the clinically indicated iCPET.
Refractory arrhythmia during or after the clinically indicated level 3 CPET.
Intervention: Nicotine
Trial phase: Phase 1 | Phase 2
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: One 0 mg or 4 mg nicotine film every 3-4 hours for a total of four films per day (not to exceed three non-consecutive 4 mg films in one day) for 6 weeks.

Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.

The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
Eligibility criteria:
Inclusion Criteria:

Aged 18-55
Smoke ≥10 cigarettes/day for at least the past 12 months
Exhaled CO measurement ≥6 ppm at baseline visit
Interested in completely ceasing cigarette consumption and using a nicotine film product as directed
Willing to attend regular visits over a 6-week period (not planning to move, not planning extended vacation, no planned surgeries)
Able to read and write in English
Able to understand and consent to study procedures

Exclusion Criteria:

Unstable or significant medical conditions and conditions such as elevated blood pressure (systolic >159 mmHg or diastolic >99mmHg at baseline), COPD, and those conditions that are likely to affect biomarker data such as kidney or liver disease
Individuals with sodium-restricted diet, heart disease, recent heart attack, irregular heartbeat, stomach ulcers, or diabetes as well as those taking prescription medications for depression or asthma as indicated under "Warnings" section on FDA approved NRT Drug Facts Label
More than weekly use in the past 3 months of illegal drugs or prescription drugs that are not being used for medically prescribed purposes
Use of non-cigarette nicotine delivery product in the prior 7 days (including cigars, pipes, chew, snus, hookah, electronic cigarette and marijuana mixed with tobacco)
Use of an FDA approved cessation medication in the past 7 days (any NRT, Chantix, Wellbutrin)
Women who are pregnant (verified by urine pregnancy test at baseline visit), trying to become pregnant, or nursing
Uncontrolled mental illness or substance abuse or inpatient treatment for these conditions in the past 6 months
Any previous adverse reaction to NRT
Any other condition, serious illness, or situation that would, in the investigator's opinion, make it unlikely that the participant could comply with the study protocol
Other member of household currently participating in the study
Intervention: Nicotine
Trial phase: Phase 1 | Phase 2
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: One 2 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.

Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.

The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
Eligibility criteria:
Inclusion Criteria:

Aged 18-55
Smoke ≥10 cigarettes/day for at least the past 12 months
Exhaled CO measurement ≥6 ppm at baseline visit
Interested in completely ceasing cigarette consumption and using a nicotine film product as directed
Willing to attend regular visits over a 6-week period (not planning to move, not planning extended vacation, no planned surgeries)
Able to read and write in English
Able to understand and consent to study procedures

Exclusion Criteria:

Unstable or significant medical conditions and conditions such as elevated blood pressure (systolic >159 mmHg or diastolic >99mmHg at baseline), COPD, and those conditions that are likely to affect biomarker data such as kidney or liver disease
Individuals with sodium-restricted diet, heart disease, recent heart attack, irregular heartbeat, stomach ulcers, or diabetes as well as those taking prescription medications for depression or asthma as indicated under "Warnings" section on FDA approved NRT Drug Facts Label
More than weekly use in the past 3 months of illegal drugs or prescription drugs that are not being used for medically prescribed purposes
Use of non-cigarette nicotine delivery product in the prior 7 days (including cigars, pipes, chew, snus, hookah, electronic cigarette and marijuana mixed with tobacco)
Use of an FDA approved cessation medication in the past 7 days (any NRT, Chantix, Wellbutrin)
Women who are pregnant (verified by urine pregnancy test at baseline visit), trying to become pregnant, or nursing
Uncontrolled mental illness or substance abuse or inpatient treatment for these conditions in the past 6 months
Any previous adverse reaction to NRT
Any other condition, serious illness, or situation that would, in the investigator's opinion, make it unlikely that the participant could comply with the study protocol
Other member of household currently participating in the study
Intervention: Nicotine
Trial phase: Phase 1 | Phase 2
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: One 0 mg nicotine film every 3-4 hours for a total of four films per day for 6 weeks.

Nicotine Film: Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.

The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
Eligibility criteria:
Inclusion Criteria:

Aged 18-55
Smoke ≥10 cigarettes/day for at least the past 12 months
Exhaled CO measurement ≥6 ppm at baseline visit
Interested in completely ceasing cigarette consumption and using a nicotine film product as directed
Willing to attend regular visits over a 6-week period (not planning to move, not planning extended vacation, no planned surgeries)
Able to read and write in English
Able to understand and consent to study procedures

Exclusion Criteria:

Unstable or significant medical conditions and conditions such as elevated blood pressure (systolic >159 mmHg or diastolic >99mmHg at baseline), COPD, and those conditions that are likely to affect biomarker data such as kidney or liver disease
Individuals with sodium-restricted diet, heart disease, recent heart attack, irregular heartbeat, stomach ulcers, or diabetes as well as those taking prescription medications for depression or asthma as indicated under "Warnings" section on FDA approved NRT Drug Facts Label
More than weekly use in the past 3 months of illegal drugs or prescription drugs that are not being used for medically prescribed purposes
Use of non-cigarette nicotine delivery product in the prior 7 days (including cigars, pipes, chew, snus, hookah, electronic cigarette and marijuana mixed with tobacco)
Use of an FDA approved cessation medication in the past 7 days (any NRT, Chantix, Wellbutrin)
Women who are pregnant (verified by urine pregnancy test at baseline visit), trying to become pregnant, or nursing
Uncontrolled mental illness or substance abuse or inpatient treatment for these conditions in the past 6 months
Any previous adverse reaction to NRT
Any other condition, serious illness, or situation that would, in the investigator's opinion, make it unlikely that the participant could comply with the study protocol
Other member of household currently participating in the study
Intervention: Rapastinel
Trial phase: Phase 3
SMILES: CC(O)C(N)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(C(N)=O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Rapastinel (prefilled syringe, weekly intravenous IV administration).
Eligibility criteria:
Inclusion Criteria:

Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test

Exclusion Criteria:

DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1

Lifetime history of meeting DSM-5 criteria for:

Schizophrenia spectrum or other psychotic disorder
Bipolar or related disorder
Major neurocognitive disorder
Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
Dissociative disorder
Posttraumatic stress disorder
MDD with psychotic features
Significant suicide risk, as judged by the investigator
Intervention: Rapastinel
Trial phase: Phase 3
SMILES: CC(O)C(N)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(C(N)=O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Rapastinel (prefilled syringe, weekly intravenous IV administration).
Eligibility criteria:
Inclusion Criteria:

Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
Treatment naive in the current episode or have inadequate response to 1-3 antidepressant therapies given at adequate dose and duration in the current episode
If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test

Exclusion Criteria:

DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1

Lifetime history of meeting DSM-5 criteria for:

Schizophrenia spectrum or other psychotic disorder
Bipolar or related disorder
Major neurocognitive disorder
Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
Dissociative disorder
Posttraumatic stress disorder
MDD with psychotic features
Significant suicide risk, as judged by the investigator
Intervention: Lidocaine
Trial phase: Early Phase 1
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 90
Group description: All subjects were monitored as a single group for adverse reactions
Eligibility criteria:
Inclusion Criteria:

Exclusion Criteria for both arms:

(1) known adverse reactions to lidocaine; (2) ADHD, ADD, and other inattention disorders; (3) epilepsy, IQ <80, severe head trauma, birth weight <2270 grams, and severe autism; (4) treatment currently with potassium or potassium-elevating drugs such as renin-angiotensin-aldosterone blockers; (5) generalized anxiety disorders (but dental-specific anxiety will not be an exclusion because many of these individuals may be ones with anxiety because of painful dental experiences with lidocaine ineffectiveness); (6) mouth sores; (7) Ehlers Danlos syndrome, (8) red hair, and (9) current pregnancy.
Intervention: Ketorolac
Trial phase: Phase 3
ATC code: M01AB15 | S01BC05 | S01FB51
SMILES: O=C(c1ccccc1)c1ccc2n1CCC2C(=O)O
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 74
Group description: Subjects randomized to the Ketorolac protocol will receive the study postoperative pain protocol. This includes 6 doses of IV Ketorolac, scheduled every 6 hours. The first dose is administered in the operating room or post-operative care unit.

Ketorolac: The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.
Eligibility criteria:
Inclusion Criteria:

Women presenting for care at Tufts Medical Center as an outpatient in obstetrics clinic or on Labor and Delivery.
The subject must have had a cesarean section for any indication at Tufts Medical Center to be randomized to the study
The subject is willing to have a phone call follow up conversation 2 weeks after their surgery.

Exclusion Criteria:

Patients with allergy to ketorolac, NSAIDS or aspirin
Patients with peptic ulcer disease, preexisting kidney or liver disease.
Duramorph is not used as the anesthetic for the spinal/epidural during the cesarean section.
Patient is hemodynamically unstable due to hemorrhage.
Patient requires therapeutic anticoagulation in the post-operative period
Patients with peripartum cardiomyopathy
Provider decision to exclude patient.
Patient diagnosis of chronic hypertension, gestational hypertension, preeclampsia, HELLP syndrome, or eclampsia
A study subject may participate in another research study while participating in this research study.
Intervention: Daridorexant
Trial phase: Phase 3
ATC code: N05CJ03
SMILES: COc1ccc(-n2nccn2)c(C(=O)N2CCC[C@@]2(C)c2nc3c(C)c(Cl)ccc3[nH]2)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 142
Group description: Film-coated tablets administered orally, once daily in the evening

Daridorexant 10 mg: Daridorexant 10 mg tablets
Eligibility criteria:
Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure (Visit 1).
Having completed the DB study treatment and the run-out period of ID-078A301 (NCT03545191) or ID-078A302 (NCT03575104).

For woman of childbearing potential, the following is required:

Negative urine pregnancy test (EOT of ID-078A301 or ID-078A302 studies)
Agreement to use the contraception scheme as required by the protocol from Visit 1 up to at least 30 days after EODBT.

Exclusion Criteria:

Unstable medical condition, significant medical disorder or acute illness, C-SSRS©, ECG, hematology or biochemistry test results in ID-078A301 and ID-078A302, which in the opinion of the investigator could affect the subject's safety or interfere with the study assessments (Visit 1).
For female subjects: lactating or planning to become pregnant during the duration of the study (Visit 1).
Positive urine drug test (for benzodiazepines, barbiturates, cannabinoids, opiates, amphetamines, or cocaine) or presence of alcohol in exhaled breath as detected by breathalyzer test (EOT of ID-078A301 or ID-078A302 studies if same day as Visit 1 or Visit 1 if within 7 days after EOT).