anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
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: Accepts Healthy Volunteers
Participants at risk: 108
Group description: Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)

Acetaminophen
Eligibility criteria:
Inclusion Criteria:

Patients' ≥ 6 months - 6 years
Patients must meet criteria for American Society of Anesthesiologists (ASA) physical status I, II.
Patients must not be pre-medicated.
Parents must give written consent on the surgery day and be able to sign informed consent form on the surgery day.
Undergoing BMT surgery only.

Exclusion Criteria:

Patients' <6 months and >6 years.
Patients with known allergies to any of the medications used in this study.
Patients with ASA status III & IV.
Patients taking prescription pain medications prior to surgery.
Patients taking medication that can cause drowsiness or alter mental status (eg. benzodiazepines, cough suppressants, diphenhydramine)
Patients with significant history of psychiatric illness, neurologic disease (seizure disorder requiring medication therapy), and developmental delay.
Patients have been pre-medicated.
Patients undergoing other procedures that would prolong anesthetic exposure or confound post-operative pain.
Intra-op complication that would require prolonged anesthetic exposure.
If patient took acetaminophen prior to surgery and was not supposed to do so
Patients that received ketorolac or additional analgesia during surgery.
Patients that have liver disease.
Intervention: Acetaminophen
Trial phase: Phase 2
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: 21
Group description: Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.

Acetaminophen
Eligibility criteria:
Inclusion Criteria:

Males and Female >=18 years old
Admitted to an Intensive Care Unit
Severe Sepsis
Detectable plasma cell-free hemoglobin

Exclusion Criteria:

patients who received acetaminophen in the past 48 hours prior to enrollment
intolerance or allergy to acetaminophen
measured AST/ALT >400 U/L in the 24 hours prior to enrollment
chronic liver disease defined by a Child-Pugh score >4
cannot swallow or have no enteral feeding access
patients with no detectable cell-free hemoglobin
patients transitioned to palliative care
pregnant patients or women of childbearing potential without a documented pregnancy test
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: 140
Group description: Subjects will receive 1000mg of intravenous acetaminophen every 6 hours for 24 hours beginning with dural closure.

Acetaminophen
Eligibility criteria:
Inclusion Criteria:

Subject are able to provide informed consent prior to participation in the study
Subjects must be scheduled to undergo elective open craniotomy procedure of > 2 hour duration
Subjects must be >18 years old but less than 90 years old
Subjects must have an American Society of Anesthesiologists (ASA) class I-IV
Subjects must have the ability to communicate meaningfully with the investigator staff and read/understand the study procedures and the use of pain scales

Exclusion Criteria:

Subjects used opioids or tramadol daily for >7 days before study medication administration
Subjects had been treated with any of the following within 14 days of surgery: chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian
Subjects who have a chronic pain condition, significant medical disease or laboratory abnormality that in the investigator's judgment could compromise the subject's welfare
Subjects with known hypersensitivity to opioids, acetaminophen or the inactive ingredients
Subjects with known or suspected history of alcohol or drug abuse or dependence in the previous 2 years prior to the proposed surgery
Intervention: Vemurafenib
Trial phase: Phase 4
ATC code: G01AE10 | L01EC01 | L01XE15
SMILES: CCCS(=O)(=O)Nc1ccc(F)c(C(=O)c2c[nH]c3ncc(-c4ccc(Cl)cc4)cc23)c1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Participants received oral vemurafenib at 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.
Eligibility criteria:
Inclusion Criteria:

BRAF V600 mutation-positive malignancy
Prior eligibility for and on study treatment from an antecedent vemurafenib protocol
Ability to begin treatment in the extension (rollover) protocol within 15 days following the last day of the study in the antecedent protocol
Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use 2 adequate methods of contraception as defined by protocol during the course of this study and for at least 6 months after completion of study treatment

Exclusion Criteria:

Adverse event requiring discontinuation of vemurafenib in the antecedent protocol
Progressive disease during the antecedent protocol. If approval to treat beyond progression was already given in the antecedent protocol, the participant may roll over into the current protocol without sponsor approval. Under special circumstances, enrollment into this protocol and dosing beyond progression may be considered and will require approval of the sponsor

Participants meeting any of the following exclusion criterion of the antecedent study at the time the participant is considered for the extension (rollover) study:

Current, recent (within 28 days prior to Day 1), or planned use of any antitumor therapy outside this study
Any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the participant or compromise the participant's ability to participate in the study
History of malabsorption or other clinically significant metabolic dysfunction
History of clinically significant cardiac or pulmonary dysfunction as specified in antecedent study
Intervention: Fluoxetine
Trial phase: Not Applicable
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 3
Group description: Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
Eligibility criteria:
Inclusion Criteria:

Male and female adolescents ages 13-17
Current diagnosis of Major Depressive Disorder as determined by the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL), Children's Depression Rating Scale (CDRS-R) raw score > 45 (T-score > 65) at baseline
Estimated full scale IQ > 80 as determined by the Wechsler Intelligence Scale for Children (WISC)
Able to receive outpatient care
Willing to discontinue other psychosocial treatments
Not taking psychotropic medications in the one month prior to consent, with the exception of psychostimulant medication prescribed for the treatment of attention-deficit/hyperactivity disorder (ADHD)

Exclusion Criteria:

Current or past diagnosis of bipolar, schizophrenia, schizophreniform, schizoaffective disorders, or psychosis not otherwise specified
Current diagnosis of developmental disorder, severe conduct disorder, life-threatening anorexia, obsessive-compulsive disorder, or autism-spectrum disorders
Taking psychotropic medications prior to entry
Estimated IQ < 80
Alcohol/drug dependence or abuse within the last 3 months
Potential/confirmed neurological disorder or epilepsy
Claustrophobia
Presence of a medical condition that precludes fMRI
Endorsement of imminent and serious suicidality
Medical conditions for which treatment with fluoxetine is contraindicated or that take precedence over the presence of major depressive disorder (MDD)
Pregnancy
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: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: 0.6 mg/kg once

Rocuronium: 0.6 mg/Kg once
Eligibility criteria:
Inclusion criteria:

Infants admitted to the NICU at Beaumont Children's Hospital Royal Oak and Troy.
Gestational Age 28 0/7 weeks (or post menstrual age 28 0/7 weeks) or higher
Infants who require endotracheal intubation on a non-emergent basis
Signed informed consent by parents

Exclusion criteria:

intubations that occurred in the delivery room or for other emergent basis,
absence of intravenous access
abnormality of the airway
known or family history of neuromuscular disorder
renal insufficiency (urine output <0.6 mL/kg per hour or creatine >1.7 mg/dL if > 1 day of age)
known hepatic insufficiency (abnormal liver function or coagulation laboratory results)
Current diagnosis of pulmonary hypertension
Any infant deemed by the attending neonatologist as unstable or unfit for the study
Intervention: Timolol Maleate
Trial phase: Phase 1 | Phase 2
SMILES: CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.O=C(O)C=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: 5 patients received Topical timolol maleate 0.5% drops. Applied twice daily for 12 weeks (84 days) Study drops were applied to 3 cutaneous telangiectasias per patient. Each patient had 2 lesional biopsies (one at baseline, and one at end of treatment)
Eligibility criteria:
Inclusion Criteria:

Definite clinical or genetic diagnosis of HHT
Known ENG or ALK1 mutation (personal or familial)
Age>=18 years
At least 5 typical (round/ovoid, not spider or linear) cutaneous telangiectasia (size range 2-5mm) on hands (not including lesions on over inter-phalangeal joints) or face

Exclusion Criteria:

Contraindication to systemic beta-blocker (severe asthma, severe COPD, sinus bradycardia, 2nd or 3rd degree AV block, overt heart failure, hypotension, allergy/intolerance/ hypersensitivity to timolol)
Current treatment with systemic beta-blocker
Current participation in other therapeutic trial for HHT
Current pregnancy or breastfeeding.
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 | Adult
Healthy volunteers: No
Participants at risk: 160
Group description: Acetaminophen 15 mg/kg oral single dose
Eligibility criteria:
Inclusion Criteria:

Children with migraine without aura (MoA) diagnosed according to the criteria for pediatric age of the International Classification of Headache Disorders (IHS-2)
aged from 5 to 18 years
at least four attacks /month

Exclusion Criteria:

mental retardation (IQ <70)
genetic syndromes (e.g., Down syndrome, Prader-Willi syndrome, fragile X syndrome)
hypothyroidism
psychiatric disorders (i.e.: schizophrenia, mood disorders, ADHD),
neuromuscular disorders,
epilepsy,
obesity (BMI>95 percentiles),
liver or renal diseases,
gastrointestinal disorders such as peptic or duodenal ulcer, dyspepsia, or heartburn;
hypersensitivity to medication studies.
Intervention: Cimetidine
Trial phase: Phase 3
ATC code: A02BA01 | A02BA51
SMILES: CN/C(=N/C#N)NCCSCc1nc[nH]c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
Eligibility criteria:
Inclusion Criteria:

Provision of informed consent prior to any study specific procedures.
Female or male aged =18 years and =70 years.
Acute upper gastrointestinal bleeding (haematemesis, melaena or haematochezia) or such signs within the last 24 hours as judged by the investigator.
One endoscopically confirmed bleeding gastric or duodenal peptic ulcer, at least 5 mm in diameter, classified as Forrest Ia, Ib, IIa, or IIb. Photo documentation of the source of bleeding should be provided.
Successful haemostasis (which is considered to have been established if bleeding has stopped and, if applicable, formerly bleeding vessels are flattened or cavitated) achieved by endoscopic treatment and confirmed by site staff.

Exclusion Criteria:

Endoscopic suspicion of gastric malignancy or juxta pyloric stenosis as judged by the investigator.
Sign of multi PUB or concomitant other gastro bleeding from esophageal varices, reflux esophagitis, gastritis, Mallory Weiss rifts, ulcus simplex, Dieulafoy's lesion, colon, small bowel, or ulcer distal to the stom in Billroth-resected patients.
Need for treatment during the first 7 days of the study with NSAIDs, Cyclooxygenase-2 (COX-2) inhibitors, acetyl salicylic acid (ASA) (including low dose) or clopidogrel.
Planned treatment with: warfarin (including other vitamin K antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine.
Chemotherapy or radiation therapies within 2 weeks prior to randomisation or planned during the course of the study.
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: No
Participants at risk: 39
Group description: subjects receiving metformin

Metformin: metformin 1000 mg bid
Eligibility criteria:
Inclusion Criteria:

Prior completion of at least two months in a diet, exercise and lifestyle intervention program within the past two years
Fasting plasma glucose >90 mg/dl plus 2-hour glucose ≥140 mg/dl on 75 gm OGTT plus HbA1C ≤7.0%. There is no lower limit for the A1C and no upper limit for the OGTT 2-hour glucose based on prior studies that allow us to identify people with falling β-cell function
Age 22-65 years
Body mass index (BMI) 30-40 kg/m2
For participants with diabetes, known duration <1 year
No history of use of antidiabetic medications except during pregnancy

Exclusion Criteria:

Contraindications to LapBand(see Appendix 1)
Contraindication to MRI (claustrophobia; permanent metal objects such as pacemakers, prostheses, aneurysm clips)
Underlying disease(s) likely to (a) limit life span to less than study duration and/or (b) increase risk of intervention outside of the study and/or (c) limit ability to participate in outcomes assessment and/or (d) limit participation
An underlying disease known to have important effects on glucose metabolism
Active infections
Renal disease (serum creatinine ≥1.4 mg/dl for men; ≥1.3 mg/dl for women) or serum potassium abnormality (<3.4 or >5.5 mmol/l)
Anemia (hemoglobin <11g/dl in women, <12 g/dl in men) or known coagulopathy
Cardiovascular disease, including uncontrolled hypertension and symptomatic congestive heart failure. Participants must be able to safely tolerate administration of fluid/volume challenges during clamp studies.
Serum AST >3 times upper limit of normal in local clinical lab
Excessive alcohol intake
Suboptimally treated thyroid disease

Conditions or behaviors likely to affect the conduct of the study

unable or unwilling to give informed consent
unable to adequately communicate with clinic staff
another household member is a participant or staff member
current or anticipated participation in another intervention research project that would interfere with any of the interventions/outcomes
likely to move away from participating clinic in next 2 years
current (or anticipated) pregnancy and lactation.
major psychiatric disorder that, in the opinion of clinic staff, would impede the conduct of the study
weight loss >5% in past three months for any reason except postpartum weight loss.
additional conditions may serve as criteria for exclusion at the discretion of the local site
Intervention: Sirolimus
Trial phase: Phase 2
ATC code: L01EG04 | L04AA10 | S01XA23
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.

Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy.
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically proven squamous cell skin carcinoma
Recipient of a renal organ transplant at least one year prior to study enrollment
Receiving a CNI for at least 6 months prior to diagnosis of skin cancer
No current evidence of graft rejection, except low-grade, chronic graft rejection
Measurable disease by caliper measurement
Life expectancy > 6 months
Age of at least 18 years
Adequate organ and marrow function as determined by ANC, HGB, PLT, Total Bili, AST, and creatinine clearance
Ability to understand/willingness to sign a written informed consent form

Exclusion Criteria:

Inability to give informed consent
Major surgery within 4 week prior to starting study drug
Chronic or non-healing open wounds
Pregnant and nursing women
Women and men of child-bearing potential must agree to use adequate contraception prior to study entry and for the study duration
Prior use of an mTOR inhibitor
Pre-existing clinically significant cardiac, hepatic, pulmonary, or renal dysfunction
HIV-positive patients
Proteinuria (> 1 gram)
Prior or current history of uncontrolled hyperlipidemia (cholesterol > 302 mg/dl or triglycerides 354 mg/dl
Currently receiving any investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to sirolimus (mTOR inhibitors)
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Intervention: Metformin
Trial phase: Phase 3
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: 65
Group description: Metformin will be titrated to the maximum dose tolerated (up to 2000 mg/day). Participants randomized to the metformin-alone arm will be blinded to treatment.

Metformin: Titrated to 1000 mg BID
Eligibility criteria:
Inclusion Criteria:

Fasting plasma glucose 95-125 mg/dl plus 2-hour glucose ≥140 mg/dl on 75 gm OGTT plus HbA1c ≤7.0%. There is no upper limit for the 2-hour glucose on OGTT.
Age 20-65 years
Body mass index (BMI) ≥25 kg/m2 but ≤50 kg/m2
Self-reported diabetes <1 year in duration
Drug naïve (no prior to oral glucose lowering agent(s), insulin or other injectable glucose lowering agents)

Exclusion Criteria:

Underlying disease likely to limit life span and/or increase risk of intervention or an underlying condition that is likely to limit ability to participate in outcomes assessment
An underlying disease that affects glucose metabolism other than type 2 diabetes
Taking medications that affect glucose metabolism, or has an underlying condition that is likely to require such medications
Active infections
Renal disease (serum creatinine >1.4 mg/dl for men; >1.3 mg/dl for women) or serum potassium abnormality (<3.4 or >5.5 mmol/l)
Anemia (hemoglobin <11 g/dl in women, <12 g/dl in men) or known coagulopathy
Cardiovascular disease, including uncontrolled hypertension. Participants must be able to safely tolerate administration of intravenous fluids required during clamp studies.

History of conditions that may be precipitated or exacerbated by a study drug:

Pancreatitis
Serum alanine transaminase (ALT) more than 3 times the upper limit of normal
Excessive alcohol intake
Suboptimally treated thyroid disease
Medullary carcinoma of the thyroid or MEN-2 (in participant or a family history)
Hypertriglyceridemia (>400 mg/dl despite treatment)

Conditions or behaviors likely to affect the conduct of the RISE Study

Unable or unwilling to give informed consent
Unable to adequately communicate with clinic staff
Another household member is a participant or staff member in RISE
Current, recent or anticipated participation in another intervention research project that would interfere with any of the interventions/outcomes in RISE
Weight loss of >5% in past three months for any reason other than post-partum weight loss. Participants taking weight loss drugs or using preparations taken for intended weight loss are excluded.
Likely to move away from participating clinics in next two years
Women of childbearing potential who are unwilling to use adequate contraception
Current (or anticipated) pregnancy and lactation.
Major psychiatric disorder that, in the opinion of clinic staff, would impede the conduct of RISE
Additional conditions may serve as criteria for exclusion at the discretion of the local site.