anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Fingolimod
Trial phase: Phase 2 | Phase 3
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.

Fingolimod: Produced by Osveh ® Pharm Company in Iran

Fish Oil: produced by Zahravi ® Pharm Company in Iran
Eligibility criteria:
Inclusion Criteria:

Patients with relapsing-remitting multiple sclerosis according to McDonald's criteria (2010)
Age between 18 and 45 years
Expanded Disability Status Scale (EDSS) between 0-5
History of at least one relapse during the last year
Intolerance or serious complications when receiving interferons
Not receiving interferons in the last two months
Not having relapse in the last 30 days
Negative pregnancy test
History of varicella or varicella vaccination, or positive test for anti-varicella antibodies
Not to take any medication or dietary complement without permission of the physician
Filling informed consent

Exclusion Criteria:

Having chronic and infectious diseases
History of cardiovascular diseases
Taking corticosteroids in the last 30 days
Taking chemotherapy agents such as Cyclophosphamide
Patients who have taken fingolimod before
Patients who experience relapse during the study
Intervention: Saracatinib
Trial phase: Phase 2
SMILES: CN1CCN(CCOc2cc(OC3CCOCC3)c3c(Nc4c(Cl)ccc5c4OCO5)ncnc3c2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 33
Group description: Participants will take 125 mg of saracatinib daily for 8 days.

Saracatinib: Saracatinib 125 mg once per day for 8 days
Eligibility criteria:
Inclusion Criteria:

Ages 21-50
Able to read English at 6th grade level or higher and to complete study evaluations
Regular alcohol drinker

Exclusion Criteria:

Individuals who are seeking alcohol treatment
Medical conditions that would contraindicate the use of saracatinib
Regular use of other substances
Intervention: Metformin
Trial phase: Phase 1 | Phase 2
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Standard release metformin (500 mg tablets) was initiated and titrated to maximum dose of metformin 1000 mg twice daily over 3 weeks and continued for 12 weeks

Metformin: Metformin 500mg oral tablet
Eligibility criteria:
INCLUSION CRITERIA:

Youth must self-identify as African-American and identify both parents as African-American
Age 12-25 years
Pubertal or post-pubertal: Girls Tanner stage IV-V breast; Boys Testicular volume 11-25cc
Diagnosis of type 2 diabetes of less than or equal to 5 years duration, as per American Diabetes Association Criteria
Hemoglobin A1C <9% at study initiation
Negative to mild ketonuria without acidosis (negative or 1+ ketones on urinalysis)
Negative test for diabetes-related autoantibodies (glutamic acid decarboxylase 65 and tyrosine phosphatase-related islet antigen 2 (IA-2))
Willing and able to take daily medications and check blood glucose levels at least twice per day or wear a continuous glucose monitoring device (CGM).

EXCLUSION CRITERIA:

Pregnancy or breastfeeding
Allergy to study medications
Allergy to milk protein
Chronic insulin therapy
Treatment with other medications which are known to affect the parameters under study (for example sodium glucose transporter 2 (SGLT-2) inhibitors, dipeptidyl peptidase-4 (DPP-IV) inhibitors, non-selective beta blockers).
Metabolic derangement such as metabolic acidosis, severe hyperglycemia (fasting blood glucose greater than or equal to 200mg/dL), and/or liver enzymes > three times the upper limit of normal.
Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2
Any other condition that, in the opinion of the investigators, will increase risk to the subject, or impede the accurate collection of study-related data.
Body weight greater than or equal to 450 lbs
Body weight less than or equal to 58kg
Serum triglyceride concentrations greater than or equal to 500mg/dl
Hemoglobin concentration <10g/dL
Intervention: Perflutren
Trial phase: Phase 2
SMILES: FC(F)(F)C(F)(F)C(F)(F)F
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: Patients who are scheduled for a clinically indicated prostate biopsy, and who are able to undergo contrast enhanced transrectal ultrasound will be included in this single arm study. Each of the study subjects will receive in intravenous infusion of a microbubble contrast agent known as Definity™, (Perflutren Lipid Microsphere, Lantheus Medical Imaging, Inc; N. Billerica, MA). Based upon our previous experience, two vials of Perflutren Lipid Microsphere will be mixed and diluted in 50 ml of normal saline, yielding a concentration of 49.4 μl/ml. For the purpose of contrast-enhanced imaging, Perflutren Lipid Microsphere will be infused over approximately 10-12 minutes, during which time ultrasound imaging and biopsy will be performed.

Perflutren Lipid Microsphere Intravenous Suspension: The intravenous administration of Perflutren Lipid Microsphere will provide enhancement of vascular tissue when performing subharmonic prostate ultrasound imaging. This enhancement will be used
Eligibility criteria:
Inclusion Criteria:

Subject must be scheduled for a clinically indicated needle biopsy of the prostate based upon an elevated PSA, abnormal digital rectal examination, or based upon active surveillance of prostate cancer.
Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate.
Subject must be a male at least 18 years of age when informed consent is obtained.
Subject must have a life expectancy that exceeds the duration of the clinical trial.

Exclusion Criteria:

Participant in a clinical trial involving an investigational drug within the past 30 days.
Prior allergic reaction to the ultrasound contrast agent Definity™
Previous treatment for PCa.
Clinically unstable, severely ill, or moribund.
Intervention: Ivacaftor
Trial phase: Phase 2
ATC code: R07AX02 | R07AX30 | R07AX31 | R07AX32
SMILES: CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Participants received VX-561 100 mg orally once daily for 28 days.
Eligibility criteria:
Inclusion Criteria:

18 years of age or older
Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R.
Has been stable on Kalydeco therapy for at least 3 months prior to screening
Has FEV1 ≥ 60% of predicted normal for age, sex, and height at screening and baseline (Day 1) assessments
Weighs at least 40 kg at screening
Patients of either gender and women of childbearing potential must be willing to use a medically highly effective form of birth control during the treatment period and 30 days after the last dose of study treatment.

Exclusion Criteria:

Acute upper respiratory infection or lower respiratory infection, pulmonary exacerbation, or changes in therapy within 4 weeks of study treatment
Uncontrolled type 2 diabetes, or uncontrolled CF-related diabetes
History of hepatitis C or chronic active hepatitis B infection
History of pulmonary tuberculosis, non-tuberculosis mycobacterial infections or allergic bronchopulmonary aspergillosis (ABPA) treated during screening or within 2 years prior to screening
Colonization with B. cenocepacia, B. dolosa, B. multivorans, and/or M. abcessus within 2 years prior to Screening
Abnormal liver function
History of abnormal renal function
History of prolonged QTcF > 450 msec for males or QTcF > 470 msec for females
History of solid organ or hematological transplantation
Using any inhibitor or inducer of cytochrome P450/3A during the study or within 30 days of screening
Women who are pregnant or lactating, or have plans to become pregnant during the study or within 1 month following the last dose
Intervention: Ivacaftor
Trial phase: Phase 2
ATC code: R07AX02 | R07AX30 | R07AX31 | R07AX32
SMILES: CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Participants received VX-561 150 mg orally once daily for 28 days.
Eligibility criteria:
Inclusion Criteria:

18 years of age or older
Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R.
Has been stable on Kalydeco therapy for at least 3 months prior to screening
Has FEV1 ≥ 60% of predicted normal for age, sex, and height at screening and baseline (Day 1) assessments
Weighs at least 40 kg at screening
Patients of either gender and women of childbearing potential must be willing to use a medically highly effective form of birth control during the treatment period and 30 days after the last dose of study treatment.

Exclusion Criteria:

Acute upper respiratory infection or lower respiratory infection, pulmonary exacerbation, or changes in therapy within 4 weeks of study treatment
Uncontrolled type 2 diabetes, or uncontrolled CF-related diabetes
History of hepatitis C or chronic active hepatitis B infection
History of pulmonary tuberculosis, non-tuberculosis mycobacterial infections or allergic bronchopulmonary aspergillosis (ABPA) treated during screening or within 2 years prior to screening
Colonization with B. cenocepacia, B. dolosa, B. multivorans, and/or M. abcessus within 2 years prior to Screening
Abnormal liver function
History of abnormal renal function
History of prolonged QTcF > 450 msec for males or QTcF > 470 msec for females
History of solid organ or hematological transplantation
Using any inhibitor or inducer of cytochrome P450/3A during the study or within 30 days of screening
Women who are pregnant or lactating, or have plans to become pregnant during the study or within 1 month following the last dose
Intervention: Acetaminophen
Trial phase: Phase 3
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.

Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
Eligibility criteria:
Inclusion Criteria :

American Society of Anesthesiologists physical status (ASA) < III
Age 18-40 year
Body Weight <110 kg
Height between 160 and 175 cm
Gestational age>37 SA
Elective cesarean delivery
Singleton pregnancy
Non complicated pregnancy
Signed informed consent obtained prior to any study specific assessments and procedures

Exclusion Criteria:

Twin pregnancy
History of 2 cesarean section or more
Diabetes and gestational diabetes
Placenta praevia
Congenital foetal abnormality
Intrauterine growth retardation
Patient in labour
Membrane rupture
Known allergy to local anaesthetics
Standard contraindications to neuraxial block.
Disagreement of the patient
Neurological impairment
Gestational low blood pressure
Pre eclampsia and eclampsia
Intervention: Latanoprost
Trial phase: Phase 3
ATC code: S01EE01 | S01EE51
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 185
Group description: Latanoprost ophthalmic solution: Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Eligibility criteria:
Inclusion Criteria:

Patients with open angle glaucoma or ocular hypertension in both eyes

Exclusion Criteria:

Patients at risk of progression of visual field loss
Patients with severe visual field defect
Patients with any diseases that preclude participation in this study for safety reasons
Intervention: Metformin
Trial phase: Phase 4
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months.
Eligibility criteria:
Inclusion Criteria:

Age 65 - 79

Must meet criteria from one or more of the following groups:

Group 1 (Can have 1 or 2 of these, but not all 3)

History of coronary artery disease (MI/heart attack, stroke, heart failure, or peripheral artery disease)
Cancer, with no active treatment in the last year
MCI (MoCA >18<26 -inclusive of 1 point if <12 years of education Group 2
Decline physical function (walking speed < 1 m/s) Group 3 (Either or both)
Abdominal obesity (>88cm women, >102cm men) AND hypertension (treated or resting blood pressure >140/90
Abdominal obesity (>88cm women, >102cm men) AND hyperlipidemia (treated or fasting total cholesterol >240 English literacy Willing to provide informed consent

Exclusion Criteria:

eGFR <45
Type 2 diabetes (HbA1c>6.5) or type 1 diabetes
Any tobacco or nicotine product use in the past year
Low vitamin B12 Levels (< 300 pg/mL)
Self-reported severe difficulty or inability to walk 400m or climb 10 steps (from Q 2 and 19 on PAT-D)
Self-reported difficulty or inability to perform basic ADL functions (from Q 10, 13, 14, 16 on PAT-D)
Excessive alcohol use (>14 drinks/week)
Cancer requiring treatment in past year (except skin)
Dementia - diagnosed and/or MoCA score <18
Parkinson's or other neurological disease
Chronic liver disease or cirrhosis
End stage renal disease or on dialysis
Rheumatic conditions (Rheumatoid arthritis, lupus, and any other autoimmune disease the -PI deems them to be ineligible for)
Thyroid problems the PI deems them to be ineligible for
Gout
Involved in another interventional study
Hemoglobin <8 or diagnosed with anemia
Recent unintentional weight change (+/- 10 lbs. in the last 12 months)
BMI <18.5
Likely to not follow the protocol
PI deems unfit to participate
Already taking Metformin or any other drug intended to treat diabetes
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: Child
Healthy volunteers: No
Participants at risk: 74
Group description: Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision.

Acetaminophen
Eligibility criteria:
Inclusion Criteria:

Patients ages 3 years to 17 years scheduled for tonsillectomy and adenoidectomy for obstructive sleep apnea with or without additional minor procedures such as sleep endoscopy, unilateral or bilateral myringotomy, insertion of tympanostomy tubes and/or ear exam. ( Minor additional procedures that are frequently combined with tonsillectomy and adenoidectomy but are not commonly considered to have pain that is significantly greater than the tonsillectomy and adenoidectomy).

Exclusion Criteria:

Patients who meet University of California Davis Children's Hospital (UCDCH) criteria for Pediatric Intensive Care Unit (PICU) admission: on home oxygen pre-operatively, exhibit airway obstruction when awake (stertor above larynx, stridor at larynx), sleep study with apnea hypoxia index greater than 25 or sleep oxygen saturation nadir <80%, cardiac disease, difficult intubation.
Patients with a known allergy to acetaminophen
Patients with known hepatic insufficiency or severe hepatic disease
Patients with known Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Patients who are malnourished (ie lower levels of glutathione)
Patients with severe renal impairment as defined by calculated creatinine clearance <20 ml/min (per modified Schwarz equation)
Patients who are pregnant
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: Child
Healthy volunteers: No
Participants at risk: 74
Group description: Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision.

Acetaminophen
Eligibility criteria:
Inclusion Criteria:

Patients ages 3 years to 17 years scheduled for tonsillectomy and adenoidectomy for obstructive sleep apnea with or without additional minor procedures such as sleep endoscopy, unilateral or bilateral myringotomy, insertion of tympanostomy tubes and/or ear exam. ( Minor additional procedures that are frequently combined with tonsillectomy and adenoidectomy but are not commonly considered to have pain that is significantly greater than the tonsillectomy and adenoidectomy).

Exclusion Criteria:

Patients who meet University of California Davis Children's Hospital (UCDCH) criteria for Pediatric Intensive Care Unit (PICU) admission: on home oxygen pre-operatively, exhibit airway obstruction when awake (stertor above larynx, stridor at larynx), sleep study with apnea hypoxia index greater than 25 or sleep oxygen saturation nadir <80%, cardiac disease, difficult intubation.
Patients with a known allergy to acetaminophen
Patients with known hepatic insufficiency or severe hepatic disease
Patients with known Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Patients who are malnourished (ie lower levels of glutathione)
Patients with severe renal impairment as defined by calculated creatinine clearance <20 ml/min (per modified Schwarz equation)
Patients who are pregnant
Intervention: Zerbaxa
Trial phase: Phase 4
SMILES: CC1(Cn2ccnn2)C(C(=O)O)N2C(=O)CC2S1(=O)=O.Cn1c(N)c(NC(=O)NCCN)c[n+]1CC1=C(C(=O)[O-])N2C(=O)C(NC(=O)C(=NOC(C)(C)C(=O)O)c3nsc(N)n3)C2SC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: One dose of 3 grams ceftolozane/tazobactam will be administered to each study participant.

Ceftolozane/tazobactam: Single dose of 2 grams/1 gram intravenously administered over 60 minutes.
Eligibility criteria:
Inclusion Criteria:

Male and female subjects, ages 18-80 years, of all racial and ethnic origins.
Non-English Spanish speakers will be included in the study.
We are recruiting 12 patients with thermal burn injuries (percent total body surface area burned >/= 20%). Patients will be at least five days from the date of the burn injury.
Patients will have central venous or arterial line access.
Patients will be already be receiving standard of care antimicrobial therapy for a suspected infection.

Exclusion Criteria:

Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of ceftolozane and tazobactam on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of ceftolozane and tazobactam, so that the pregnancy and post-partum state would be a confounding variable.
Abnormal liver function tests: transaminases >10 times upper limit of normal, Alkaline phosphatase >5 times upper limit of normal, total bilirubin >5 times upper limit of normal.
History of allergies to beta-lactam antibiotics.
Patients unwilling to comply with study procedures.
Current or previous participation within 28 days of enrollment in another research study that involves the use of medication, contrast, or any other compound that may alter blood count and/or blood chemistry (liver function, kidney function or electrolyte balance), unless waved by principal investigator (PI).
Donation of 450mL (one unit) of blood or more within 8 weeks (56 days) prior to study enrollment, unless waved by PI.
Creatinine clearance < 30 ml/min as estimated by the Cockcroft-Gault equation.
Patients who are receiving piperazillin/tazobactam or have received piperacillin/tazobactam within the past 48 hours.
Patients who are receiving vasopressors.
Patients with a total body weight < 60 kg or > 130 kg.
Intervention: Metformin
Trial phase: Not Applicable
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os
Eligibility criteria:
Inclusion Criteria:

Patients with type 2 diabetes mellitus (T2DM) without coronary artery disease (CAD)
Patients with T2DM and CAD.
Obese patients (BMI >30 Kg/m²) with abnormal oral glucose tolerance test (OGTT)

Exclusion Criteria:

valvular heart disease
congestive heart failure
peripheral vascular disease
liver or kidney failure
history of alcohol or drug abuse
Intervention: Acetaminophen
Trial phase: Not Applicable
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 202
Group description: This arm will be assigned a postpartum analgesic regimen with acetaminophen.

Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief
Eligibility criteria:
Inclusion Criteria:

Delivery occurred at equal to or greater than 24 0/7 weeks gestational age
Patient receiving care with the Women's Perinatal Group (Maternal Fetal Medicine practice) or Obstetric Clinic resident services
Diagnosis of a hypertensive disorder of pregnancy (HDP), including the following:
Gestational hypertension
Preeclampsia without severe features
Preeclampsia with severe features
Hemolysis, Elevated Liver Enzymes, Low Platelet (HELLP) Syndrome
Eclampsia

Exclusion Criteria:

Diagnosis of chronic hypertension or documentation of elevated blood pressures before 20 weeks gestational age.
Severe hypertension: Patients with at least one severe blood pressure measurement (systolic >160mmHg or diastolic >105mmHg) prior to randomization
Renal dysfunction (Serum creatinine measurement >1.3mg/dL during the current pregnancy)
Low platelet count (recorded measurement <50,000 during hospital admission)
Significant liver dysfunction (AST or ALT >500)
Known sensitivities to ibuprofen or acetaminophen
Use of therapeutic doses of anticoagulation (low dose anticoagulation used for routine prophylaxis of venous thromboembolism is acceptable)
Postpartum hemorrhage requiring transfusion