anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Rosuvastatin Calcium
Trial phase: Phase 4
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1C=CC(O)CC(O)CC(=O)[O-].CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1C=CC(O)CC(O)CC(=O)[O-].[Ca+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Participants receiving statin therapy. A participant's cardiologist could change the treatment regimen that a participant was assigned to so that no participant was restricted from statin therapy. The results reflect the treatment each participant actually received rather than the treatment each participant was randomized to.
Eligibility criteria:
Inclusion Criteria:

Age 22 and above with prior head and neck or chest irradiation
Six months or more post head and neck irradiation
Documented subclinical cardiovascular disease (inflammatory markers in the serum)
Pre-existing plaques (detected by ultrasound, CT or MRI)
Asymptomatic major arterial stenosis
Not being considered for arterial surgery or endovascular treatment.

Exclusion Criteria:

Recurrence of cancer (with or without treatment)
Planned surgical or endovascular intervention for revascularization of carotid arteries at the time of enrollment
Renal failure
Estimated glomerular filtration rate (eGFR) < 45 (calculation based on serum creatinine levels, race, age and gender)
Medically unstable or hematologic, renal, or hepatic dysfunction
Non-atherosclerotic arterial stenosis (dissection)
Presence of stents or external clips that can cause artifacts impairing accurate interpretation of MRI data
Contraindications to MRI: cardiac pacemaker, metal implants, metal in eyes, pregnant or nursing women, claustrophobia, allergy to MRI contrast
Physical or mental impairment that would limit the patient's ability to comply with the medical instructions or study procedures
Intervention: Resveratrol
Trial phase: Phase 2
SMILES: Oc1ccc(/C=C/c2cc(O)cc(O)c2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Resveratrol capsules, 500 mg, three times per day before meals during 90 days

Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.
Eligibility criteria:
Inclusion Criteria:

Patients both sexes
Age between 30 and 50 years
Metabolic Syndrome according to the IDF criteria
Waist circumference
Man ≥90 cm
Woman ≥80 cm
And two of the following criteria:
High density lipoprotein
Man ≤40 mg/dL
Woman ≤50 mg/dL
Fasting glucose ≥100 mg/dL
Triglycerides ≥150 mg/dL
Blood pressure ≥130/85 mmHg
Informed consent signed

Exclusion Criteria:

Women with confirmed or suspected pregnancy
Women under lactation and/or puerperium
Hypersensibility to resveratrol
Physical impossibility for taking pills
Known uncontrolled renal, hepatic, heart or thyroid diseased
Previous treatment for the metabolic syndrome components
Body Mass Index ≥39.9 kg/m2
Fasting glucose ≥126 mg/dL
Triglycerides ≥500 mg/dL
Total cholesterol ≥240 mg/dL
Low density lipoprotein (c-LDL) ≥190 mg/dL
Blood Pressure ≥140/90 mmHg
Intervention: Terbutaline
Trial phase: Phase 2 | Phase 3
ATC code: R03AC03 | R03CC03 | R03CC53
SMILES: CC(C)(C)NCC(O)c1cc(O)cc(O)c1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 6
Group description: 0.25 mL of Intravenous Terbutaline

Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline.
Eligibility criteria:
Inclusion Criteria:

Female
Between 18-35 years of age
37 weeks gestation
Breech presentation

Exclusion Criteria:

Patients with ruptured membranes
Multiple gestation
Maternal age (age > 35)
With known medical comorbidities (including hypertension (HTN), arrhythmias, endocrinologic diseases such as diabetes and thyroid disease, scoliosis, asthma)
Allergies to nitroglycerine or terbutaline
Prior abdominal or uterine surgery
Intervention: Nitroglycerin
Trial phase: Phase 2 | Phase 3
ATC code: C01DA02 | C01DA52 | C05AE01
SMILES: O=[N+]([O-])OCC(CO[N+](=O)[O-])O[N+](=O)[O-]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 6
Group description: IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.

Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it's short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
Eligibility criteria:
Inclusion Criteria:

Female
Between 18-35 years of age
37 weeks gestation
Breech presentation

Exclusion Criteria:

Patients with ruptured membranes
Multiple gestation
Maternal age (age > 35)
With known medical comorbidities (including hypertension (HTN), arrhythmias, endocrinologic diseases such as diabetes and thyroid disease, scoliosis, asthma)
Allergies to nitroglycerine or terbutaline
Prior abdominal or uterine surgery
Intervention: Ubidecarenone
Trial phase: Phase 4
ATC code: C01EB09
SMILES: COC1=C(OC)C(=O)C(CC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)CCC=C(C)C)=C(C)C1=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Known cases of idiopathic dilated cardiomyopathy

Coenzyme Q10: dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance
Eligibility criteria:
Inclusion Criteria:

Known cases of Idiopathic Dilated Cardiomyopathy (IDC)
Those patients in whom heart failure medications were stable for at least 1 month
More than 6 months aged

Exclusion Criteria:

Recent modification in medications
Hemodynamic instability
Congenital heart disease
Metabolic heart disease
Cardiac dysfunction resulting from abnormalities in other organs and those with an acquired cardiomyopathy
Intervention: Indomethacin
Trial phase: Not Applicable
ATC code: C01EB03 | M01AB01 | M01AB51 | M02AA23 | S01BC01 | S01CC02
SMILES: COc1ccc2c(c1)c(CC(=O)O)c(C)n2C(=O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 482
Group description: Patients in this group will receive 20 ml of normal saline sprayed on the duodenal papilla and surrounding regions of edema, over a period of 1 minute using any ERCP cannulation catheter, at the end of procedure, just before the withdrawal of endoscope; followed by 100 mg of rectal indomethacin.

Rectal Indomethacin
Eligibility criteria:
Inclusion Criteria:

Major inclusion criteria (If patients meet at least 1 of the criteria):

History of PEP
Pancreatic sphincterotomy
Pre-cut sphincterotomy
Difficult cannulation (>5 attempts / 10 minutes to cannulate)
Failed cannulation
Pneumatic dilation of an intact sphincter
Sphincter of Oddi dysfunction of Type I or Type II

Minor inclusion criteria (If patients meet at least 2 of the criteria):

Age < 50 & Female gender
History of acute pancreatitis (at least 2 episodes)
>/= 3 pancreatic injections (with at least 1 injection in tail)
Pancreatic acinarization
Pancreatic Brush Cytology

Exclusion Criteria:

Unwillingness or inability to consent for the study
Age < 18 years
Intrauterine pregnancy
Breastfeeding mother
Standard contraindications to ERCP
Allergy / hypersensitivity to aspirin or NSAIDs or epinephrine
Chronic renal disease (Cr > 1.4)
Active or recent (within 4 weeks) gastrointestinal hemorrhage
Acute pancreatitis (lipase peak) within 72 hours
Known chronic calcific pancreatitis
Pancreatic head mass
Receiving pancreatic duct stent placement for any indication
Procedure performed on major papilla/ventral pancreatic duct in patients with pancreas divisum
ERCP for pancreatic/biliary stent removal or exchange without anticipated pancreatogram
Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
Anticipated inability to follow protocol
Sphincter of Oddi dysfunction of Type III
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: 67
Group description: Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
Eligibility criteria:
Inclusion Criteria:

Moderate to severe major depressive disorder

Exclusion Criteria:

Prior treatment with botulinum toxin of any serotype for any reason
Use of antidepressant medication for depression within 2 weeks of study
Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
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: 58
Group description: Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1.
Eligibility criteria:
Inclusion Criteria:

Moderate to severe major depressive disorder

Exclusion Criteria:

Prior treatment with botulinum toxin of any serotype for any reason
Use of antidepressant medication for depression within 2 weeks of study
Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
Intervention: Kenalog
Trial phase: Phase 2
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: Single 5 mL IA injection
Eligibility criteria:
Main Inclusion Criteria:

Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Male or female >=40 years of age
Has documented diagnosis of OA of the index knee made at least 6 months prior to Screening
Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee per Screening X-ray
Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
Body mass index (BMI) ≤ 40 kg/m2
Willingness to abstain from use of restricted medications

Main Exclusion Criteria:

Ipsilateral hip OA
Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
History of arthritides due to crystals (e.g., gout, pseudogout)
History or clinical signs and symptoms of infection in the index joint
Knee pain that is not clinically attributable to OA of the knee (e.g., radicular low back pain and hip pain that is referred to the knee that could cause misclassification)
Pain in any other area of the lower extremities or back that is equal to or greater than the index knee pain
IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
Intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of Screening
Oral corticosteroids (investigational or marketed) within 1 month of Screening
Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of Screening
Any other IA investigational drug/biologic within 6 months of Screening
Prior use of FX006
Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Intervention: Kenalog
Trial phase: Phase 2
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 104
Group description: Single 5 mL IA injection
Eligibility criteria:
Main Inclusion Criteria:

Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
Male or female >=40 years of age
Has documented diagnosis of OA of the index knee made at least 6 months prior to Screening
Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA
Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee per Screening X-ray
Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
Body mass index (BMI) ≤ 40 kg/m2
Willingness to abstain from use of restricted medications

Main Exclusion Criteria:

Ipsilateral hip OA
Fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
History of arthritides due to crystals (e.g., gout, pseudogout)
History or clinical signs and symptoms of infection in the index joint
Knee pain that is not clinically attributable to OA of the knee (e.g., radicular low back pain and hip pain that is referred to the knee that could cause misclassification)
Pain in any other area of the lower extremities or back that is equal to or greater than the index knee pain
IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
Intramuscular (IM) corticosteroids (investigational or marketed) within 3 months of Screening
Oral corticosteroids (investigational or marketed) within 1 month of Screening
Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of Screening
Any other IA investigational drug/biologic within 6 months of Screening
Prior use of FX006
Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Intervention: IC Green
Trial phase: Not Applicable
ATC code: V04CX01
SMILES: CC1(C)C(=CC=CC=CC=CC2=[N+](CCCCS(=O)(=O)[O-])c3ccc4ccccc4c3C2(C)C)N(CCCCS(=O)(=O)[O-])c2ccc3ccccc3c21.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Indocyanine green: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
Eligibility criteria:
Inclusion Criteria:

Age 18 and above
Patients undergoing an EEA for cranial base pathology that may require nasoseptal flap harvest

Exclusion Criteria:

History of sulfa, iodide, or penicillin allergy
Pregnant or breast feeding
Preoperative lack of indication for nasoseptal flap harvest
Previous anaphylactic reaction to ICG
Intervention: Healon
Trial phase: Phase 4
SMILES: CC(=O)NC1C(O)OC(CO)C(O)C1OC1OC(C(=O)O)C(OC2OC(CO)C(O)C(OC3OC(C(=O)O)C(O)C(O)C3O)C2NC(C)=O)C(O)C1O.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: 1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
Eligibility criteria:
Inclusion Criteria:

Use of artificial tears for dry eye in both eyes for at least 3 months
Use of preservative-free artificial tears at least twice daily for 2 weeks;

Exclusion Criteria:

Cataract, laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK) surgery in the last 12 months
Use of punctal plugs or contact lenses in the last month
Active ocular allergy within last 2 years
Best corrected visual acuity (BCVA) less than 20/200 in either eye
Intervention: Memantine
Trial phase: Phase 2
ATC code: N06DA52 | N06DA53 | N06DX01
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 58
Group description: Up to 20 mg memantine taken by mouth twice a day for 36 weeks.
Eligibility criteria:
Inclusion Criteria:

Age 18-85
Male or Female
Clinically definite, probable, probable lab-supported, or possible ALS by El Escorial criteria
ALSFRS-R > 25
Must be willing to undergo longitudinal blood draws for biomarker analysis
Availability and willingness to complete the study
Capable of providing informed consent and complying with trial procedures
If patients are taking riluzole and/or Radicava, they must be a on a stable dose for at least thirty days prior to the baseline.

Exclusion Criteria:

Patients with forced vital capacity (FVC) ≤ 60%
History of liver disease
Severe renal failure
History of intolerance to memantine
Onset of weakness for greater than 3 years
Any other co-morbid condition which would make completion of the trial unlikely
If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use birth control.
Taking any investigational medications. If the patient was previously on investigational medications, a 30-day washout period is required before the baseline visit. Non-trial medications are not cause for exclusion.
Unwillingness to provide consent

Remote Inclusion Criteria:

Age 18-85
Male or Female
Clinically definite, probable, probable lab-supported, or possible ALS by El Escorial criteria
ALSFRS-R > 25
Must be willing to undergo longitudinal blood draws for biomarker analysis. This may be foregone during the screening visit
Availability and willingness to complete the study
Capable of providing informed consent and complying with trial procedures
If patients are taking riluzole and/or Radicava, they must be a on a stable dose for at least thirty days prior to the baseline
Documentation of not clinically significant liver enzymes within the previous 6 months

Remote Exclusion Criteria:

Patients with FVC ≤ 60%*
History of liver disease
Severe renal failure
History of intolerance to memantine
Onset of weakness for greater than 3 years
Any other co-morbid condition which would make completion of the trial unlikely
If female, pregnant or breast-feeding; or, if of childbearing age, an unwillingness to use birth control.
Taking any investigational medications. If the patient was previously on investigational medications, a 30-day washout period is required before the baseline visit. Non-trial medications are not cause for exclusion.

Unwillingness to provide consent

Since FVC cannot be captured during a remote screening visit, and acceptable FVC performed within the previous 90 days is acceptable. If an FVC is not available within the previous 90 days, the subject may be enrolled if the local site PI believes the subject has no significant shortness of breath or respiratory issues.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
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: Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point.

Normal Saline: Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point.
Eligibility criteria:
Inclusion Criteria:

Adult patients diagnosed with MPS of the trapezius, gluteus medius/minimus, iliocostalis thoracis-lumborum, quadratus Lumborum, or paraspinal muscles in the emergency department.

Exclusion Criteria:

Patients allergic to lidocaine and/or steroids.
Pregnant women.
Prisoners.
Patients who are cognitively impaired and/or unable to consent for the study.
Age < 18.
Signs of localized infection or skin breakdown at the injection site.
Intervention: Norgestrel
Trial phase: Phase 4
ATC code: G03AA06 | G03FA10 | G03FB01
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum

Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled.
Eligibility criteria:
Inclusion Criteria:

Desiring a LNG-IUS
Postpartum, ages 18-45 who deliver at a gestational age > 32 weeks, delivery can be via cesarean or vaginal delivery
Following a viable, singleton pregnancy
Willing to return to UNC for their LNG-IUS insertion and study follow-up
Who plan to stay in the UNC area for 6 months and willing to return to UNC for 3 visits
Fluent in English or Spanish
At risk of repeat pregnancy (i.e. excluding those who had tubal sterilization)

Exclusion Criteria:

No genital bleeding of unknown etiology
No personal history of known or suspected breast carcinoma
No 4th degree vaginal laceration at time of delivery
No documented uterine rupture during delivery
No active liver disease (resolved pre-eclampsia may enroll)
No evidence of vaginal, cervical or uterine infection at time of LNG-IUS insertion
No history of postpartum endometritis treated with antibiotics or a postpartum readmission for a dilation and curettage
No pre-existing contraindication to a LNG-IUS as determined by the CDC's Medical Eligibility Criteria (MEC) category 3 or 4
Not currently incarcerated
No known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity
No suspected hypersensitivity or contraindication to the LNG-IUS
With any other condition or circumstance that the PI determines could cause an adverse event or interfere with completing the study.
Intervention: Betamethasone
Trial phase: Phase 3
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: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 145
Group description: Dexamethasone 700 μg was administered as intravitreal injection in the study eye on Day 1, Months 5, and 10.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of diabetes mellitus (type 1 or type 2)
Presence of macular edema

Exclusion Criteria:

Anticipated need for ocular surgery in the study eye during the study
Laser photocoagulation in the study eye within 3 months
Cataract surgery within 3 months