anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement. After administration of the placebo, the GJ placement procedure will be performed using conventional technique. An IR technologist observing the procedure will record the fluoroscopy time, air kerma, and chronological time will be recorded by an IR technologist at the following routine events during GJ tube placement procedures: 1) start of gastric insufflation, 2) needle access to the stomach, 3) wire intubation of the duodenum, 4) wire intubation of the jejunum, 5) and procedure completion.

Saline: A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement.
Eligibility criteria:
Inclusion Criteria:

18 years old or older
undergoing de novo GJ placement as part of their routine clinical care

Exclusion Criteria:

Patient pregnant

Contraindications to metoclopramide including:

allergic reaction
pheochromocytoma
QTc prolongation
history of seizure disorder
extrapyramidal symptoms
Intervention: Perfluorohexyloctane
Trial phase: Phase 2
SMILES: CCCCCCCCC(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 111
Group description: Perfluorohexyloctance solution 2 times daily (BID)

NOV03: Perfluorohexyloctane
Eligibility criteria:
Inclusion Criteria:

Signed ICF (Informed Consent Form)
Subject-reported history of Drye Eye Disease (DED) in both eyes
Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

Women who are pregnant, nursing or planning pregnancy
Unwillingness to submit a blood pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
Clinically significant slit-lamp findings or abnormal lid anatomy at screening
Ocular/peri-ocular malignancy
History of herpetic keratitis
Active ocular allergies or ocular allergies that are expected to be active during the study
Ongoing ocular or systemic infection
Wear contact lenses within 1 month prior to screening or anticipated use of contact lenses during the study
Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have planned ocular and/or lid surgeries over the study period
Presence of uncontrolled systemic diseases
Presence of known allergy and/or sensitivity to the study drug or saline components
Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears or topical anti-glaucoma medication within 2 months prior to screening
Intervention: Perfluorohexyloctane
Trial phase: Phase 2
SMILES: CCCCCCCCC(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 114
Group description: Perfluorohexyloctance solution 4 times daily

NOV03: Perfluorohexyloctane
Eligibility criteria:
Inclusion Criteria:

Signed ICF (Informed Consent Form)
Subject-reported history of Drye Eye Disease (DED) in both eyes
Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

Women who are pregnant, nursing or planning pregnancy
Unwillingness to submit a blood pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
Clinically significant slit-lamp findings or abnormal lid anatomy at screening
Ocular/peri-ocular malignancy
History of herpetic keratitis
Active ocular allergies or ocular allergies that are expected to be active during the study
Ongoing ocular or systemic infection
Wear contact lenses within 1 month prior to screening or anticipated use of contact lenses during the study
Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have planned ocular and/or lid surgeries over the study period
Presence of uncontrolled systemic diseases
Presence of known allergy and/or sensitivity to the study drug or saline components
Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears or topical anti-glaucoma medication within 2 months prior to screening
Intervention: Atropine
Trial phase: Phase 3
ATC code: A03BA01 | A03BA03 | A03CB03 | A03CB31 | S01FA01
SMILES: CN1C2CCC1CC(OC(=O)C(CO)c1ccccc1)C2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 125
Group description: 0.01% atropine eyedrops administered 1 drop to each eye daily in each eye for 24 months, followed by 6 months off atropine eyedrops

Atropine: Daily 0.01% atropine eyedrops
Eligibility criteria:
Inclusion Criteria:

Age 5 years to <13 years at time of enrollment. Children within 4 weeks of their 13th birthday are not eligible.

Refractive error meeting the following by cycloplegic autorefraction:

Myopia -1.00D to -6.00D spherical equivalent (SE) in both eyes
Astigmatism <=1.50D in both eyes
Anisometropia <1.00D SE
Gestational age ≥ 32 weeks.
Birth weight >1500g.
Parent understands the protocol and is willing to accept randomization to atropine or placebo.
Is willing to participate in a 2 to 4 week run-in phase using daily artificial tear eyedrops.
Able to return in 2 to 4 weeks for possible randomization.
Parent has a phone (or access to phone) and is willing to be contacted by Investigator's site staff.
Relocation outside of the area of an active PEDIG site within next 32 months is not anticipated.

Exclusion Criteria:

Current or previous myopia treatment with atropine, pirenzepine or other anti-muscarinic agent.
Current or previous use of bifocals, progressive-addition lenses, or multi-focal contact lenses.
Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression.
Known atropine allergy.
Abnormality of the cornea, lens, central retina, iris or ciliary body.
Current or prior history of manifest strabismus, amblyopia, or nystagmus.
Prior eyelid, strabismus, intraocular, or refractive surgery.
Down syndrome or cerebral palsy.

Females who are pregnant, lactating, or intending to become pregnant within the next 30 months.

A negative urine pregnancy test will be required for all females who have experienced menarche.
Intervention: Gabapentin
Trial phase: Phase 2
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Each 1-week condition will consist of an in-person study visit for assessment and dispensing of medication (Day 1), titration to maximum dose (i.e., 1,200mg gabapentin) (Days 1-5), MRI (Day 5), and medication washout (Days 5-7).

Gabapentin: 5 day trial of gabapentin with titration to 1,200mg
Eligibility criteria:
Inclusion Criteria:

Meets DSM-V criteria for Bipolar Disorder
Meets DSM-V criteria for Cannabis Use Disorder
Using at least one mood stabilizing medication

Exclusion Criteria:

Serious medical or non-inclusionary psychiatric disease
Concomitant use of benzodiazepine medications or any medications hazardous if taken with gabapentin
History of clinically significant brain injury
Presence of non-MRI safe material, or clinically significant claustrophobia.
Intervention: Gabapentin
Trial phase: Phase 4
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 38
Group description: Single preoperative dose of 600 mg, as described above, plus an additional postoperative regimen. Patients will take 300 mg gabapentin every 8 hours for 1 week after discharge, then a single nightly dose of 300 mg gabapentin for another month.

Gabapentin: 600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery.
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age
Receiving surgery for total knee replacement (TKR)
Opioid naïve
Agrees to use tracking diary to monitor opioid consumption

Exclusion Criteria:

Over 75 years of age on the date of surgery
If female, pregnant
Has received investigational articles < 30 days prior to enrollment or is currently receiving investigational products or devices
Chronic pain syndrome
Taking chronic narcotics and/or taking more than 10 mg of codeine per day, any amount of Hydrocodone, over 200 mg of tramadol per day, or any other narcotics prescribed for moderate or severe pain
Involved in pain clinics for chronic pain, or pain that is not related to the surgical site
On long-term gabapentin regimen
Taking Lyrica or Gralise
Known history of depression or has been treated for depression with medication
Has entertained suicidal thoughts and behaviors
Intervention: Azithromycin
Trial phase: Phase 4
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 66228
Group description: Communities will receive four rounds of biannual mass azithromycin.

Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months
Eligibility criteria:
Inclusion Criteria:

Communities- All communities eligible for MORDOR (NCT02047981)
Individuals-All children aged 1-60 months (up to but not including the 5th birthday), as assessed via biannual census

Exclusion Criteria:

Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)
Intervention: Betamethasone
Trial phase: Phase 2
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Patients in the Dexamethasone arm will be administered the drug at the time of induction.

Dexamethasone: Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.
Eligibility criteria:
Inclusion Criteria:

Women over the age of 18
Women scheduled for vaginal POP reconstructive surgery with or without concomitant anti-incontinence procedure and with or without hysterectomy
ASA class 1-2

Exclusion Criteria:

Daily use of steroids, antiemetics in the month prior to surgery
Chronic pain requiring daily opioid treatment
History of allergy/intolerance to Dexamethasone
ASA class 3
Numerical Pain score of more than 4 at baseline
Renal/Liver disease
Diabetes mellitus
Pregnancy
Inability to answer questionnaires
Any systemic infections
Immuno compromised status
Patients with planned overnight stay
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: The placebo arm patients will receive normal saline at the time of induction.

Normal saline: Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.
Eligibility criteria:
Inclusion Criteria:

Women over the age of 18
Women scheduled for vaginal POP reconstructive surgery with or without concomitant anti-incontinence procedure and with or without hysterectomy
ASA class 1-2

Exclusion Criteria:

Daily use of steroids, antiemetics in the month prior to surgery
Chronic pain requiring daily opioid treatment
History of allergy/intolerance to Dexamethasone
ASA class 3
Numerical Pain score of more than 4 at baseline
Renal/Liver disease
Diabetes mellitus
Pregnancy
Inability to answer questionnaires
Any systemic infections
Immuno compromised status
Patients with planned overnight stay
Intervention: ASCORBIC ACID
Trial phase: Phase 2 | Phase 3
ATC code: A11GA01 | A11GB01 | B03AA10 | G01AD03 | S01XA15
SMILES: O=C1OC(C(O)CO)C(O)=C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Vitamin C

Vitamin C: Continuous infusion of vitamin C
Eligibility criteria:
Inclusion Criteria:

• Capability to provide written consent from participant or legally authorized representative (LAR) if the participant is unable or incapacitated due to severity of illness.

Age ≥ 18 years

Septic shock as pragmatically defined as:

o Order for intravenous antimicrobials with either procalcitonin > 2 mg/dL within 24 hours of enrollment OR other clinical suspicion of infection or confirmed infection AND

Hypotension requiring vasopressor therapy, despite fluid resuscitation of at least 30 cc/kg AND
Lactate > 2 mmol/L 24 hr prior to enrollment AND

Presence of sepsis defined as equal to or greater than 2 SIRS criteria and/or acute increase in qSOFA score of 2 points or more.

SIRS criteria: 1) Temperature greater than 38° or less than 36° Celsius. 2) Heart rate greater than 90 beats per minute. 3) Respiratory rate greater than 20 breaths per minute OR arterial carbon dioxide tension less than 32 mmHg. 4) White blood cell count greater than 12,000 cell/µL, less than 4,000 cells/µL, OR band cells greater than 10% of the total white blood cell population.
qSOFA: 1 point each is assigned for: 1) systolic blood pressure below 100, 2) respiratory rate greater than 22, and 3) mental status not at baseline.

Exclusion Criteria:

• Unable to start infusion within 24 hours of septic shock identification

Currently pregnant or breastfeeding
Patient to receive comfort measures only
Cardiac Arrest
Cardiovascular Surgery patients receiving prophylactic peri-operative antibiotics < 48 hours post-operation
Participation in another study involving an investigational product within 30 days of the baseline visit
Allergy to Vitamin C
History of nephrolithiasis
History of G6PD deficiency
ESRD patients, transplant eligible on dialysis currently taking vitamin C supplementation
Clinical course that treating clinician decides would preclude safe participation
Intervention: Sumatriptan
Trial phase: Phase 3
ATC code: G01AE10 | N02CC01
SMILES: CNS(=O)(=O)Cc1ccc2[nH]cc(CCN(C)C)c2c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 79
Group description: Participants will be dosed with 22 milligrams (mg) sumatriptan nasal powder via two nosepieces (11 mg per nosepiece).

sumatriptan nasal powder: nasal powder administered via nosepiece
Eligibility criteria:
Inclusion Criteria:

Male and female participants 12 to 17 years (inclusive) of age at the time of informed consent
Have a diagnosis of episodic migraine with or without aura according to International Classification of Headache Disorders-Third edition, beta version (ICHD-IIIB, 1.2.1 or 1.1) criteria, for at least 1 year prior to the screening/enrollment visit
Experienced migraine attacks of moderate-to-severe intensity and typically lasting ≥ 3 hours untreated, occurring at a frequency of ≥ 2 to ≤ 14 attacks per month for the past 6 months prior to the screening/enrollment visit
Participant's parent or legal guardian must be willing to sign a copy of the informed consent form as well as documentation for Written Authorization for Use and Release of Health and Research Study Information, after the nature and risks of study participation have been fully explained. Participants must be willing to provide informed assent.

Exclusion Criteria:

Participants with ≥ 15 headache days per month in total (migraine, probable migraine, or tension-type)
Participants with the following headache types: retinal (ICHD-IIIB, 1.2.4), with brainstem aura (ICHD-IIIB, 1.2.2), hemiplegic (ICHD-IIIB, 1.2.3), status migrainosus (ICHD-IIIB, 1.4.1), other forms of complicated migraine, or secondary headaches
Participants who have not responded to an adequate dose and appropriate duration of treatment with 2 or more triptans
Participants with known nasal obstruction, current uncontrolled nasopharyngeal illness, or known velum insufficiency (i.e., a cleft palate and/or structural abnormalities in the soft palate and nasopharynx) that may interfere with the proper use of study medication
Participants whose conditions in the investigator's opinion may put the participant at significant safety risk or confound the study results. This includes participants who in the investigator's opinion should not be enrolled in the study due to the risks described in the Warnings and Precautions or Contraindications sections of the ONZETRA Xsail Prescribing Information.
Intervention: Lovenox
Trial phase: Phase 2
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Eligible patients will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.2-0.4 IU/mL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.

Enoxaparin: Enrolled patients will receive real-time monitoring of peak and trough steady state anti-Xa levels. Out-of-range patients will receive real time dose adjustment of Enoxaparin using a clinical protocol developed with our inpatient pharmacists.
Eligibility criteria:
Inclusion Criteria:

Receiving orthopedic trauma surgery
Able to have enoxaparin initiated within 36 hours after procedure

Exclusion Criteria:

Intracranial bleeding/stroke
bleeding disorder
heparin-induced thrombocytopenia
creatinine clearance < 30 mL/minute
epidural catheter
serum creatinine > 1.6 mg/dL
Intervention: Fortical
Trial phase: Phase 4
ATC code: H05BA01
SMILES: CC(C)CC(NC(=O)C(CCCCN)NC(=O)CNC(=O)C(CC(C)C)NC(=O)C(NC(=O)C1CSSCC(N)C(=O)NC(CO)C(=O)NC(CC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CO)C(=O)NC(C(C)O)C(=O)N1)C(C)C)C(=O)NC(CO)C(=O)NC(CCC(N)=O)C(=O)NC(CCC(=O)O)C(=O)NC(CC(C)C)C(=O)NC(Cc1cnc[nH]1)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CCC(N)=O)C(=O)NC(C(=O)NC(Cc1ccc(O)cc1)C(=O)N1CCCC1C(=O)NC(CCCNC(=N)N)C(=O)NC(C(=O)NC(CC(N)=O)C(=O)NC(C(=O)NCC(=O)NC(CO)C(=O)NCC(=O)NC(C(=O)N1CCCC1C(N)=O)C(C)O)C(C)O)C(C)O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: calcitonin nasal spray, 200 mcg daily

Calcitonin: calcitonin nasal spray
Eligibility criteria:
Inclusion Criteria:

Normal TSH on levothyroxine therapy

Exclusion Criteria:

pregnant or 6 months post partum
Current or previous thyroid cancer
Congenital hypothyroidism
any tobacco use
prescribed proton pump inhibitors
prescribed steroids
taking armour thyroid, naturethroid, or any dessicated thyroid hormone
Unstable medical conditions (CKD, Cirrhosis etc)
pituitary disease
Intervention: Upadacitinib
Trial phase: Phase 3
ATC code: L04AA44 | L04AF03
SMILES: CC[C@@H]1CN(C(=O)NCC(F)(F)F)C[C@@H]1c1cnc2cnc3[nH]ccc3n12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 324
Group description: Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of CD for at least 3 months prior to Baseline.
Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
Demonstrated an inadequate response or intolerance to any biologic therapy for infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.
If female, participant must meet the contraception recommendations.

Exclusion Criteria:

Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).
Participant with the following ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
Participant with ostomy or ileoanal pouch.
Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome.
Screening laboratory and other protocol pre-specified analyses show abnormal results.
Intervention: Upadacitinib
Trial phase: Phase 3
ATC code: L04AA44 | L04AF03
SMILES: CC[C@@H]1CN(C(=O)NCC(F)(F)F)C[C@@H]1c1cnc2cnc3[nH]ccc3n12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 78
Group description: Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of CD for at least 3 months prior to Baseline.
Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score.
Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader.
Demonstrated an inadequate response or intolerance to any biologic therapy for infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.
If female, participant must meet the contraception recommendations.

Exclusion Criteria:

Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
Participant not on stable doses of CD related antibiotics, oral aminosalicylates, corticosteroids or methotrexate (MTX).
Participant with the following ongoing known complications of CD: abscess (abdominal or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.
Participant with ostomy or ileoanal pouch.
Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short gut or short bowel syndrome.
Screening laboratory and other protocol pre-specified analyses show abnormal results.