anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Thimerosal
Trial phase: Phase 2
ATC code: D08AK06
SMILES: CC[Hg]Sc1ccccc1C(=O)[O-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: BTL-TML Safety Population - All subjects enrolled and allocated to active test article except for SAEs which includes all subjects that signed informed consent.
Eligibility criteria:
Inclusion Criteria:

Clinical history of recurrent cold sores averaging 2 or more episodes per year
UV exposure is known to cause a cold sore outbreak

Exclusion Criteria:

History of abnormal reactions to sunlight
Used antiviral therapy directly prior to entering study
Any other condition which in the opinion of the Investigator may affect the results or place the subject at undue risk.
Intervention: Technetium (99mTc) sestamibi
Trial phase: Not Applicable
SMILES: [C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[Tc]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1638
Group description: Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.
Eligibility criteria:
Inclusion Criteria:

Past prior SM interpreted as negative or benign [Breast Imaging Reporting and Data System (BI-RADS) Category 1 or 2]
Past prior SM interpreted as heterogeneously dense or extremely dense

Exclusion Criteria:

Subject is unable to understand and sign the consent form
Subject is pregnant or lactating
Subject is physically unable to sit upright and still for 40 minutes
Subject has self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass, etc.)
Subject has had needle biopsy within 3 months, or breast surgery within 1 year prior to the study
Subject is currently taking tamoxifen, Evista (raloxifene), Zoladex or an aromatase inhibitor for adjuvant therapy or chemoprevention.
Intervention: Bortezomib
Trial phase: Phase 2
ATC code: L01XG01 | L01XX32
SMILES: CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.

The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11

Bortezomib
Eligibility criteria:
Inclusion Criteria:

All patients, having undergone allogeneic stem cell transplantation at our center.
Should have failed at least 2 standard treatments for autoimmune cytopenias. Standard treatments include corticosteroids, rituximab, IVIG, plasmapheresis, withdrawal of cyclosporine, cyclophosphamide and MMF. Definition of "failed" treatment will be no response of cytopenia after 2 weeks of continued treatment OR requirement of daily GCSF at 10 mcgs/kg/day for autoimmune neutropenia despite 2 weeks of treatment, transfusions of packed red blood cells or platelets 3 times weekly for 2weeks despite continued treatment OR 5days/week plasmapheresis for 2 weeks and inability to wean the duration.
Definition of autoimmune hemolytic anemia- development of anemia, where there is a hemoglobin drop of >2 g/dL/48 hours or an absolute value of hemoglobin < 8 g/dL, and evidence of hemolysis by positive direct Coombs test with compatible peripheral blood cell morphology, reticulocyte count and bilirubin level.
Definition of autoimmune neutropenia - absolute neutrophil counts < 500 for 2 weeks and presence of anti-neutrophil antibodies.
Definition of autoimmune thrombocytopenia- Platelet counts < 20,000 cells/uL for 2 weeks and presence of anti-platelet antibodies.

Exclusion Criteria:

Ongoing life threatening infections
Documented anaphylaxis to bortezomib
Failed engraftment
Relapse of primary malignancy
≥6/8 matched or haploidentical transplants
Intervention: Rocuronium
Trial phase: Phase 4
ATC code: M03AC09
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: deep neuromuscular block is given after first measurement of lap workspace one bolus dose of 1 mg/kg rocuronium is given

rocuronium: measure effect on laparoscopic workspace
Eligibility criteria:
Inclusion Criteria:

1. Laparoscopic bariatric surgery in a patient older than 18 years of age without previous laparotomy. Examples of laparoscopic bariatric procedures are gastric band, sleeve gastrectomy, gastric bypass, gastric bypass after lap band, and revision of a gastric bypass

Exclusion Criteria:

Allergies or contraindications to the use of one or more of the following drugs: propofol, rocuronium, sugammadex, remifentanyl, or sevoflurane
History of a laparotomy
Emergency laparoscopy
Intervention: Canagliflozin
Trial phase: Phase 4
ATC code: A10BD16 | A10BK02
SMILES: [H][C@@]1(c2ccc(C)c(Cc3ccc(-c4ccc(F)cc4)s3)c2)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 56
Group description: Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
Eligibility criteria:
Inclusion Criteria:

patients with a diagnosis of type 2 diabetes mellitus
patients with hypertension (seated office SBP of >=130 mmHg and <160 mmHg and seated office DBP of >= 70 mmHg at screening and at Week -2
patients on stable doses of 1 to 3 anti-hypertensive agents for at least 5 weeks before screening
patients on stable doses of 1 to 3 oral anti-hyperglycemic agents which must include metformin, for at least 8 weeks before screening

Exclusion Criteria:

a history of diabetic ketoacidosis
type 1 diabetes mellitus (T1DM)
pancreas or beta-cell transplantation
fasting C-peptide <0.70 ng/mL (0.23 nmol/L)
body mass index <30 kg/m2
has ongoing, inadequately controlled thyroid disorder
has a history of cardio-renal disease that required treatment with immunosuppressive therapy.
Intervention: Rocuronium
Trial phase: Phase 4
ATC code: M03AC09
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 91
Group description: Rocuronium 0.6 mg/kg was used as muscle relaxant to allow intubation during induction into general anesthesia and to induce deep neuromuscular blockade for the surgery. Deep neuromuscular blockade was maintained thorough the surgery until the suture of fascia of musculus rectus abdominis.
Eligibility criteria:
Inclusion Criteria:

pregnant women undergoing Cesarean section under general anesthesia
at least 18 years of age
results of a physical and laboratory preoperative examination within normal limits or clinically acceptable limits for the study
written informed consent

Exclusion Criteria:

urgent Cesarean section
multiple pregnancy
abnormal placentation
prematurity (<34 weeks)
severe fetal hypoxia
history of severe pre-existing disease
hypersensitivity or allergy to rocuronium or sugammadex

Discontinuation Criteria:

a subject's choice to end participation in the study
a subject meets any exclusion criteria during the study or equivalent criteria
lost to follow up
the investigator feels that it's in the subject's best interest to discontinue the study
Intervention: Ubiquinol
Trial phase: Phase 2
SMILES: COc1c(O)c(C)c(C/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CCC=C(C)C)c(O)c1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Depending on the patient's ability to swallow pills, patients in the experimental group will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
Eligibility criteria:
Inclusion Criteria:

Over 18 years old
Suspected or confirmed infection
Presence of 2 or more systemic inflammatory response syndrome (SIRS) criteria
Admission to the ICU

Exclusion Criteria:

Under 18 years old
Current CoQ10 supplementation
Unable to receive enteral medications
Would need a nasogastric or orogastric tube solely for the purposes of the study
Pregnancy, incarceration, mentally disability
Patient confirmed Comfort measures only, Do not resuscitate (DNR) and/or Do not intubate. Patients with DNR but intubated and being provided full care are eligible
Intervention: Acetaminophen
Trial phase: Phase 4
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 210
Group description: IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication

Intravenous acetaminophen
Eligibility criteria:
Inclusion Criteria:

> 45 kg (amenable to adult dosing)
all traumatic brain injuries NPO for at least 12 hours
all post-operative craniotomy patients
all non-operative subarachnoid hemorrhage, intraparenchymal hemorrhage, and stroke patients
all carotid endarterectomy and carotid artery stenosis patients
all endovascular patients undergoing intracranial intervention
all post-op spine patients admitted to the NCCU

Exclusion Criteria:

documented allergy to acetaminophen
documented severe hepatic impairment (Child-Pugh score > 6) or severe hepatic disease (hepatitis)
documented severe renal impairment (CrCl < 30 ml/min) Blood tests will be performed prior to study procedures that will ensure patients do not have renal impairment.
patients who are pregnant or breast feeding
Intervention: Glipizide
Trial phase: Phase 4
ATC code: A10BB07
SMILES: Cc1cnc(C(=O)NCCc2ccc(S(=O)(=O)NC(=O)NC3CCCCC3)cc2)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months

Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months.
Eligibility criteria:
Inclusion Criteria:

Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
Patients may be of either sex. Female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions.
Patients must range in age from 30 to 70 years, inclusive.
Patients must meet the American Diabetes Association (ADA) criteria (ADA 1997 Criteria: fasting plasma glucose greater than or equal to 126 mg/dl) for the diagnosis of type 2 diabetes mellitus.
Patients must be on diet therapy and/or metformin treatment for type 2 diabetes (stable dose)and have a fasting plasma glucose concentration between 126 and 260 mg/dl
Patients must have Hematocrit greater than 34 vol%.
Subjects whose body weight has been stable over the three months prior to study enrollment will be included.

Exclusion Criteria:

Patients must not have type 1 diabetes.
Patients must not have a fasting plasma glucose greater than 260 mg/dl.
Patients must not have received a thiazolidinedione for at least 3 months prior to randomization.
Patients must not be on insulin treatment or have received insulin for more than one week within the previous year prior to entry. Patients should not be on sulfonylureas, sitagliptin, or exenatide treatment.
Patients taking systemic glucocorticoids or other medications known to affect glucose tolerance are excluded.
Patients taking medications that affect gastrointestinal motility will be excluded.
Patients with a history of Congestive Heart Failure, or clinically significant cardiac, liver or kidney disease (creatinine greater than 1.5 mg/dl).
Intervention: Hydrocortisone
Trial phase: Phase 3
ATC code: A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line Hydrocortisone: • 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose
Eligibility criteria:
Inclusion Criteria:

Gestational age greater than or equal to 34 weeks at birth
Admitted to the center NICU by 48 hours of age
Intubated and mechanically ventilated for a minimum of 2 hours before 72 hours postnatal age

Exclusion Criteria:

Receiving ECMO
Intubated for the sole purpose of anticipated surgery or airway anomalies
Treatment will be limited based on poor prognosis
Receiving dexamethasone or hydrocortisone
Receiving ibuprofen or indomethacin
Congenital heart disease
Hypotension thought to result from specific, immediately remediable factors including placental hemorrhage, acute hemorrhage or tension pneumothorax
Pituitary hypoplasia or congenital adrenal hyperplasia
Any chromosomal disorder
Hypertension in the absence of inotrope therapy as defined by mean arterial blood pressure > 95th percentile
Initiation of whole body cooling for moderate or severe neonatal encephalopathy
Brain disorders or any other known structural abnormality
Major anomalies
Intervention: Nuvaring
Trial phase: Phase 4
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3C(=C)CC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Estradiol Ring per vagina every 3 months
Eligibility criteria:
Inclusion Criteria:

Postmenopausal status as defined by amenorrhea for >12 months, OR history of bilateral salpingoophrectomy, OR if the patient has had a hysterectomy defined by menopausal symptoms for >1 year OR age >55
Documented recurrent UTIs (3 or more in the last year or 2 or more in the last 6 months)- one UTI must be documented by culture, others may be documented by urinalysis
Ability to provide informed consent

Exclusion Criteria:

Use of any investigational drug or device within thirty days of screening
Urologic surgery within the past 3 months of screening or plan for surgery within one year of screening
Diagnosis of Interstitial Cystitis/painful bladder syndrome
History of urinary tract infections which require the use of IV antibiotics or where only one oral antibiotic is available for treatment, or where the risk of treatment with vaginal estrogen only is deemed unacceptable by the principle investigator secondary to the severity of prior urinary tract infections
Known etiology of infection such as, but not limited to: kidney or bladder stones, enterovaginal/vesical fistula, fecal incontinence, intermittent catheterization, indwelling catheter, poorly controlled diabetes
Urothelial cancer
Actively treated estrogen sensitive tumor (breast or endometrial cancer)
Undiagnosed vaginal bleeding
Inability to use a vaginal ring (secondary to advanced prolapse or shortened vaginal length)
Any medical reason the investigator deems incompatible with treatment with vaginal estrogen
Prolapse requiring pessary use

Deferral Criteria

Undiagnosed hematuria - may enroll after malignancy is ruled out
Use of a progestin containing intrauterine device or use of any vaginal androgens, estrogens or progestins within 3 months of enrollment - may enroll after wash out
Use of drugs/supplements known to prevent UTIs (ie cranberry products, prophylactic antibiotics, methenamine hippurate) 1 month prior to enrollment - may enroll after wash out if still meets inclusion criteria.
History of estrogen sensitive tumor (breast or endometrial cancer) - requires approval by the subject's primary oncologist or primary care physician
Intervention: CARBOCYSTEINE
Trial phase: Phase 4
ATC code: R05CB03
SMILES: N[C@@H](CSCC(=O)O)C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 66
Group description: Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)

carbocisteine cough syrup: Mucolytic
Eligibility criteria:
Inclusion Criteria:

cough attributed to URTI such as the common cold
2-5 years of age
moderate to severe day cough according to questionnaire (score at least 3 on all 3 questions relating to day cough) considering the day prior to enrollment.
moderate to severe night cough score according to questionnaire (score at least 3 of 2 of the three questions relating to the evaluation of nocturnal cough (frequency of nocturnal cough, impact of the sleep of the child and impact on the sleep of the parent)
signature of informed consent

Exclusion Criteria:

Children with the diagnosis of diseases of the lower respiratory tract: inflammation of the larynx, trachea, bronchi, pneumonia, asthma, sinusitis, allergic rhinitis, as well as heart disease.
Children who received cough medicines or drugs containing antihistamines the day prior to study entry.
Known hypersensitivity to honey or any other component of the experimental product such as Grindelia, Helichrysum, essential oils natural flavourings of Lemon, Sweet Orange, Myrtle; Lemon natural flavouring
Children who received any steroid preparation (spray nozzle , or syrup , or other similar the day before study entry )
Known sensitivity to carbocysteine specifically to the comparator Mucolit
gastric ulcer
Intervention: Eravacycline
Trial phase: Phase 3
ATC code: J01AA13 | J01AA20
SMILES: [H][C@@]12Cc3c(F)cc(NC(=O)CN4CCCC4)c(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 455
Group description: Eravacycline was administered IV at a dose of 1.5 mg/kg of body weight q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 200 mg PO BID for a total therapy of 7 dosing cycles.
Eligibility criteria:
Inclusion Criteria:

1. Male and female participants with either:

a. Pyelonephritis and normal urinary tract anatomy (approximately 50% of the total population), OR b. cUTI with at least 1 of the following conditions associated with a risk for developing cUTI: i. Indwelling urinary catheter ii. Urinary retention (approximately 100 milliliters of residual urine after voiding) iii. Neurogenic bladder iv. Partial obstructive uropathy (such as, nephrolithiasis, bladder stones, and ureteral strictures) v. Azotemia of renal origin (not congestive heart failure or volume related) such that the serum blood urea nitrogen (BUN) is elevated (>20 mg/deciliters) AND the serum BUN: creatinine ratio is <15 vi. Surgically modified or abnormal urinary tract anatomy (such as, bladder diverticula, redundant urine collection system) EXCEPT surgery within the last month

Exclusion Criteria:

1. Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in participants with cUTI, including:

Participants with a history of a levofloxacin-resistant urinary tract infection
Likely to receive ongoing antibacterial drug prophylaxis prior to the late Post-Treatment visit (such as, participants with vesiculo-ureteral reflux)
Intervention: Efavirenz
Trial phase: Phase 4
ATC code: J05AG03 | J05AR06 | J05AR11
SMILES: O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1
Group description: Healthy, reproductive-age women using the etonogestrel contraceptive implant who will take a two-week course of efavirenz 400 mg orally each night.

Efavirenz: Healthy women who are using Nexplanon will be asked to take a 2-week course of reduced-dose efavirenz (400 mg daily).
Eligibility criteria:
Inclusion Criteria:

Healthy women aged 18-40 years who have a Nexplanon®/Implanon® in place that is palpable on exam, had the device placed between 12 and 24 months prior to enrollment, and can provide documentation of when the implant was placed
Able to speak and read English
Documented HIV-negative status within 30 days of enrollment
BMI between 18.5 and 24.9 kg/m2
Willingness to take a two-week course of efavirenz
Willingness to comply with study visit schedule (as described below), including blood sampling, transvaginal ultrasounds, and cervical mucus assessment
Negative urine human chorionic gonadotropin pregnancy test at study entry

Normal laboratory values within 30 days of study entry, as specified below:

White blood cell count ≥ 4500 and ≤ 11000 cells/mm3
Platelet count ≥ 100,000 platelets/mm3
Hemoglobin ≥ 8.0 g/dL
International normalized ratio (INR) ≤ 1.8
Aspartate transaminase (SGOT) and alanine aminotransferase (SGPT) ≤ 3 times the upper limit of normal (ULN) (upper limit of normal)
Creatinine ≤ 1.5 x ULN
Serum amylase ≤ 1.5 x ULN
Total bilirubin ≤ 2.0 x ULN

Agree to use an additional reliable method of contraception while participating in the study. Acceptable methods include:

Abstinence
Condoms (male or female) with or without spermicide
Pre-existing sterilization of subject or her male partner
Willingness to abstain from alcohol consumption during the study period
Willingness to abstain from any grapefruit product or supplement for the duration of the study.

Exclusion Criteria:

Breastfeeding
Hypersensitivity to efavirenz
History of seizure disorder
Initiated, discontinued, or changed doses of drugs that are cytochrome P450 isoenzyme 3A4 (CYP3A4) inducers or inhibitors within 30 days of study entry.