anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ibuprofen
Trial phase: Phase 4
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Intravenous placebo and oral ibuprofen
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of any form of SCD, including sickle cell anemia, sickle-hemoglobin C disease, and sickle-ß˖ or ß°-thalassemia
Currently experiencing an acute painful episode (vaso-occlusive crisis), defined as acute pain in the extremities, back, abdomen, or chest that has lasted at least 4 hours and is presumed to be due to SCD, with no other identified cause
Onset of severe pain in its current location(s) must have occurred within 72 hours of study entry
Intensity of pain must be great enough to necessitate hospitalization for opioid analgesia (e.g., failure of home and outpatient therapy)
Ability to comprehend and use patient-controlled analgesia (PCA)
Score of 6 or greater on the baseline pain scale

Exclusion Criteria:

Temperature greater than or equal to 38.5ºC at the time of study entry or in the preceding 12 hours
Has a new lobar pulmonary infiltrate or a diagnosis of acute chest syndrome (i.e., a new lobar pulmonary infiltrate and two or more of the following: temperature greater than 38ºC, tachypnea, dyspnea, intercostal or supraclavicular retractions, nasal flaring, chest wall pain, and an oxygen saturation of less than 90% in room air by pulse oximetry)
Diagnosis of acute splenic or hepatic sequestration crisis (i.e., liver or spleen enlarged from steady-state size and Hgb level decreased 2 g/dL or more from steady-state value)
Currently experiencing priapism
Pain caused by suspected or confirmed hepatobiliary disease (e.g., cholecystitis or cholelithiasis)
Chronic pain caused by suspected or confirmed aseptic or avascular necrosis of the femoral or humeral heads
Chronic pain syndrome characterized by opioid tolerance and defined by hospitalization for at least 30 days for the management of pain in a 1 year period prior to study entry
Current participation (last transfusion given within the 2 months prior to study entry) in a program of chronic transfusions for the management of SCD; the use of hydroxyurea alone is permitted
Allergy or history of anaphylactoid reactions to aspirin or other NSAIDs
Kidney dysfunction (i.e., serum creatinine concentration greater than 1.5 times the upper limit of normal for age)
History of gastrointestinal bleeding or ulceration requiring medical therapy
Concomitant bleeding disorder (e.g., von Willebrand disease, hemophilia, or a qualitative platelet defect)
Any other medical condition that would make it unsafe to receive NSAIDs, as determined by the study physician
PCA not preferred
Use of ketorolac in the 30 days prior to study entry
Use of scheduled (e.g., "around the clock") opioid analgesics in the 5 days before the onset of current acute painful crisis
Pregnant
Intervention: Estradiol
Trial phase: Phase 2
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Study participants received three doses of IVIG first (Period 1) or second (Period 2 - after a twelve-week washout).
Eligibility criteria:
Inclusion Criteria:

Lung transplant recipients > 3 months after transplant surgery
Immunoglobulin G (IgG) < 500 mg/dL
Stable medical regimen

Exclusion Criteria:

Acute rejection
Active infection
Contraindication to IVIG
Pregnancy
Recent thrombotic event
Intervention: Modafinil
Trial phase: Phase 4
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 115
Group description: Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
Eligibility criteria:
Inclusion Criteria:

Ages 18-75
HIV+
Clinically significant fatigue (score of 4.5+ on Fatigue Severity Scale, plus impairment on 1+ categories of Role Function Scale)
Fatigue duration for 3+ months
English-speaking
Able to give informed consent
Fecund women uses barrier method of contraception

Exclusion Criteria:

Primary care doctor does not approve of study participation
Unstable medical condition (e.g. liver failure;cirrhosis, new onset opportunistic infection [O.I.] in past month)
Untreated hypogonadism, except for men for whom testosterone replacement is medically contraindicated (serum testosterone below the reference range)
Untreated hypothyroidism (thyroid stimulating hormone [TSH] over 5 IUI/mL)
Untreated and uncontrolled hypertension
Clinically significant anemia (hematocrit <30%)
Started testosterone or nandrolone in past 6 weeks
Started or changed an antiretroviral regimen in past 4 weeks if fatigue predated the change; otherwise, started or changed regimen in past 2 months
Untreated or under-treated major depressive disorder
Started antidepressant medication within past 6 weeks
Substance abuse/dependence (past 4 months)
Regular and frequent cannabis use (> twice/week regularly)
Currently clinically significant suicidal ideation or Hamilton Depression Rating Scale (HAM-D) >24
History or current psychosis or bipolar disorder
Pregnant or breastfeeding
Significant untreated insomnia (score >3 on HAM-D insomnia items)
Currently taking psychostimulant medication or past nonresponse to modafinil
Has no alternative viable antiretroviral regimen after the current one
Left ventricular hypertrophy; mitral valve prolapse
Intervention: FLUDROCORTISONE ACETATE
Trial phase: Phase 4
ATC code: H02AA02
SMILES: CC(=O)OCC(=O)[C@@]1(O)CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@]4(C)[C@@]3(F)[C@@H](O)C[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: fludrocortisone acetate: Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
Eligibility criteria:
Inclusion Criteria:

Syncope as a cause of loss of consciousness according to European Society of Cardiology criteria
> 2 lifetime syncopal spells preceding enrollment
> or = to -2 points on the Syncope Symptom Score for Structurally Normal Hearts
Age > 18 years with informed consent, or age > 14 years with consent and informed parental consent

Exclusion Criteria:

Other causes of syncope, such as ventricular tachycardia, complete heart block, postural (orthostatic) hypotension or hypersensitive carotid sinus syndrome
An inability to give informed consent
Important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia
Hypertrophic cardiomyopathy
A known intolerance to fludrocortisone
Another clinical need for fludrocortisone that cannot be met with other drugs
A permanent pacemaker
A seizure disorder
A major chronic non cardiovascular disease
Hypertension (blood pressure ≥ 130/85 on 2 occasions) or heart failure
Renal dysfunction (baseline glomerular filtration rate reduced below 60 ml/min/1.73m2 according to the Cockroft-Gault formula)
Diabetes mellitus
Hepatic disease
Glaucoma
Any prior use of fludrocortisone acetate
A 5-minute stand test resulting in diagnosis of postural orthostatic tachycardia syndrome or orthostatic hypotension
Intervention: FLUTICASONE PROPIONATE
Trial phase: Phase 4
ATC code: D07AC17 | R01AD08 | R01AD58 | R03BA05
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)CC)(C(=O)SCF)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 124
Group description: Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
Eligibility criteria:
Inclusion criteria:

Diagnosed with persistent asthma for 3 months or longer.
Experienced worsened asthma symptoms during physical activity.
Using an inhaled steroid for the previous 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, and Vanceril).

Exclusion criteria:

Used systemic steroids as either liquids, pills, or injections to treat asthma within the previous 3 months.
Have only intermittent, seasonal, or exercise-induced asthma, and not persistent asthma.
Admitted to a hospital within the previous 6 months due to asthma symptoms.
Any poorly controlled medical conditions that may make study participation unsafe or inappropriate in the opinion of the study physician (such as cystic fibrosis, congenital heart disease, insulin dependent diabetes, glaucoma, drug allergies, etc.)
The study physician will evaluate other medical criteria.
Intervention: Pimecrolimus
Trial phase: Phase 3
ATC code: D11AH02
SMILES: CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(Cl)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 1205
Group description: 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
Eligibility criteria:
Inclusion Criteria:

Aged 3 to < 12 months
Diagnosis of AD fulfilling the diagnostic criteria of Seymour
AD affecting at least 5% total body surface area
Investigator's Global Assessment (IGA) score of 2 or 3, corresponding to mild-to-moderate disease at baseline
Informed consent

Exclusion Criteria:

Phototherapy, systemic therapy (e.g., immunosuppressants, cytostatics), systemic corticosteroids within 4 weeks
Topical tacrolimus or pimecrolimus within 2 weeks
Topical therapy (e.g., tar, topical corticosteroids) within 3 days
Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease
Active acute viral skin infection (e.g. herpes simplex, herpes zoster, chicken pox), and/or clinically infected AD
Failure to thrive (e.g., weight or height/length below the 5th percentile) or developmental abnormalities such as head circumference less than 5th and more than 95th percentile
Known hypersensitivity to any ingredient of pimecrolimus cream 1% or topical corticosteroids
Clinical conditions other than AD that according to investigator can interfere with the evaluation
Intervention: Vorinostat
Trial phase: Phase 2
ATC code: L01XH01
SMILES: O=C(CCCCCCC(=O)Nc1ccccc1)NO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.

vorinostat
Eligibility criteria:
Inclusion Criteria:

Histologically/cytologically confirmed melanoma that is metastatic/unresectable
Residual, recurrent, or metastatic disease by radiographic examination. Measurable disease (at least 1 lesion in at least 1 dimension (longest diameter) as >20mm with conventional techniques or >10mm with spiral CT scan, within 4 weeks prior to registration
No prior therapy or 1 prior treatment (cytokine/chemotherapy/combination) for metastatic disease allowed. Patients should not take valproic acid, another histone deacetylase inhibitor, for at least 2 weeks prior to enrollment. At least 4 weeks from prior therapy to be eligible or 6 weeks if last regimen included BCNU or mitomycin C
Age>=18 years
Life expectancy >=3 months.
ECOG<2 (Karnofsky ≥60%)
Leukocytes >3,000/mcL
Absolute neutrophil count >1,500/mcL
Platelets >100,000/mcL
Total bilirubin within institutional limits
AST/ALT≤2.5Xinstitutional ULN
Creatinine within institutional limits OR creatinine clearance >60mL/min/1.73 m2 if creatinine levels above institutional limits
Eligibility of patients taking medications with potential to affect activity/PK of Vorinostat will be determined by PI
Must not use concomitant steroids except topical/inhaled use
Vorinostat effects on developing human fetus are unknown. Women of childbearing potential (WOCBP) and sexually active males must agree to use accepted/effective contraception method prior to study entry and for duration of the study
Ability to understand/willingness to sign written informed consent
Must have paraffin block of tumor tissue available for future studies

Exclusion Criteria:

Chemotherapy/radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering study
May not be receiving any other investigational agents
Known brain metastases
History of allergic reactions attributed to compounds of similar chemical/biologic composition to Vorinostat
Uncontrolled intercurrent illness including but not limited to ongoing/active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women excluded because Vorinostat is a HDAC inhibitor agent with potential for teratogenic or abortifacient effects
HIV-positive patients receiving combination antiretroviral therapy are ineligible because of potential for PK interactions with Vorinostat
Intervention: ASPIRIN
Trial phase: Not Applicable
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: Anti-inflammatory agent
Eligibility criteria:
Inclusion Criteria:

Impaired glucose tolerance

Exclusion Criteria:

Diagnosis of diabetes
Taking an ACE inhibitor (ACE-I), angiotensin II receptor blocker (ARB), or aspirin
Have systolic blood pressure >140 mm Hg
Have a chronic inflammatory disorder (i.e. rheumatoid arthritis, inflammatory bowel disease, sinusitis)
Vascular disease (cardiac, peripheral, cerebral)
Renal insufficiency or hepatic abnormalities
Gastrointestinal bleeding (defined as gastric or duodenal ulcer, hematemesis, and/or blood in the stool) or significant other upper gastrointestinal problems (i.e. gastritis) within the previous 6 months
Anemia or a history of bleeding disorder
Have a history of ARB or aspirin allergy
Have the syndrome of asthma, rhinitis, and nasal polyps
Have other medical problems which would preclude taking potential study medications for 12 months
Are pregnant or have a positive pregnancy test
Are breast feeding
Are unable or unwilling to tolerate having one catheter in each arm for 4 hours
Have health status such that the envisioned blood sampling would confer a physiologic risk
Have other physical, social, or behavioral problems which would decrease the likelihood that they would remain in the study for 12 months
Do not appear capable of giving informed consent
Intervention: Olmesartan
Trial phase: Not Applicable
ATC code: C09CA08 | C09DA08 | C09DB02 | C09DX03
SMILES: CCCc1nc(C(C)(C)O)c(C(=O)O)n1Cc1ccc(-c2ccccc2-c2nnn[nH]2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: Angiotensin receptor blocker (ARB)
Eligibility criteria:
Inclusion Criteria:

Impaired glucose tolerance

Exclusion Criteria:

Diagnosis of diabetes
Taking an ACE inhibitor (ACE-I), angiotensin II receptor blocker (ARB), or aspirin
Have systolic blood pressure >140 mm Hg
Have a chronic inflammatory disorder (i.e. rheumatoid arthritis, inflammatory bowel disease, sinusitis)
Vascular disease (cardiac, peripheral, cerebral)
Renal insufficiency or hepatic abnormalities
Gastrointestinal bleeding (defined as gastric or duodenal ulcer, hematemesis, and/or blood in the stool) or significant other upper gastrointestinal problems (i.e. gastritis) within the previous 6 months
Anemia or a history of bleeding disorder
Have a history of ARB or aspirin allergy
Have the syndrome of asthma, rhinitis, and nasal polyps
Have other medical problems which would preclude taking potential study medications for 12 months
Are pregnant or have a positive pregnancy test
Are breast feeding
Are unable or unwilling to tolerate having one catheter in each arm for 4 hours
Have health status such that the envisioned blood sampling would confer a physiologic risk
Have other physical, social, or behavioral problems which would decrease the likelihood that they would remain in the study for 12 months
Do not appear capable of giving informed consent
Intervention: Metoprolol
Trial phase: Phase 4
ATC code: C07AB02 | C07BB02 | C07BB52 | C07CB02 | C07FB02 | C07FB13 | C07FX03 | C07FX05
SMILES: COCCc1ccc(OCC(O)CNC(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Metoprolol, orally, 200mg, once daily
Eligibility criteria:
Inclusion Criteria:

Age 30-80 years old
Documented history of type 2 diabetes
Stable angiotensin converting enzyme/angiotensin receptor blocker (ACE/ARB) regimen 30 days before and throughout the study period
Stable anti-diabetic regimen throughout the study period
Body mass index (BMI) between 22-45 kg/m2
HbA1c between 6-9% for patients on anti-diabetic treatment regimen and HbA1c between 6-8% for patients who are being controlled by diet alone
Screening blood pressure (BP) > 130/80 (average of 3 sitting measurements), with current medications

Exclusion Criteria:

Uncontrollable or symptomatic arrhythmias
Unstable angina
Sick sinus syndrome or second or third degree heart block
Decompensated heart failure
Myocardial infarction (MI) or stroke within 3 months of screening
Bradycardia
Chronic obstructive pulmonary disease (COPD) with required inhaled or oral bronchodilators or corticosteroids
Bronchial asthma or related bronchospastic conditions
New onset/diagnosed type 2 diabetes (<3 months)
Clinically significant renal or liver disease (creatinine >2.5 mg/dL)
Endocrine disorders
Use of anorectic or other diet drugs inconsistent with recommendations for type 2 diabetics
Use of beta-blockers within 3 months of screening
Use of corticosteroids
Systemic disease, including cancer, with reduced life expectancy (<12 months)
Psychological illness/condition that interferes with comprehension of study requirements
Use of an investigational drug within 30 days of entry into study
Intervention: Carvedilol
Trial phase: Phase 4
ATC code: C07AG02 | C07FX06
SMILES: COc1ccccc1OCCNCC(O)COc1cccc2[nH]c3ccccc3c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Carvedilol, orally, 25 mg, once daily
Eligibility criteria:
Inclusion Criteria:

Age 30-80 years old
Documented history of type 2 diabetes
Stable angiotensin converting enzyme/angiotensin receptor blocker (ACE/ARB) regimen 30 days before and throughout the study period
Stable anti-diabetic regimen throughout the study period
Body mass index (BMI) between 22-45 kg/m2
HbA1c between 6-9% for patients on anti-diabetic treatment regimen and HbA1c between 6-8% for patients who are being controlled by diet alone
Screening blood pressure (BP) > 130/80 (average of 3 sitting measurements), with current medications

Exclusion Criteria:

Uncontrollable or symptomatic arrhythmias
Unstable angina
Sick sinus syndrome or second or third degree heart block
Decompensated heart failure
Myocardial infarction (MI) or stroke within 3 months of screening
Bradycardia
Chronic obstructive pulmonary disease (COPD) with required inhaled or oral bronchodilators or corticosteroids
Bronchial asthma or related bronchospastic conditions
New onset/diagnosed type 2 diabetes (<3 months)
Clinically significant renal or liver disease (creatinine >2.5 mg/dL)
Endocrine disorders
Use of anorectic or other diet drugs inconsistent with recommendations for type 2 diabetics
Use of beta-blockers within 3 months of screening
Use of corticosteroids
Systemic disease, including cancer, with reduced life expectancy (<12 months)
Psychological illness/condition that interferes with comprehension of study requirements
Use of an investigational drug within 30 days of entry into study
Intervention: Oxaliplatin
Trial phase: Phase 2
ATC code: L01XA03
SMILES: NC1CCCCC1N.O=C([O-])C(=O)[O-].[Pt+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 168
Group description: 5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
Eligibility criteria:
Inclusion Criteria:

First-line mCRC
EGFR positive
Bi-dimensional measurable index lesion

Exclusion Criteria:

Previous exposure to EGFR-targeting therapy
Previous oxaliplatin-based therapy
Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment
Radiotherapy
Surgery
Any other investigational drug in the 30 days before randomization
Brain metastasis and/or leptomeningeal disease
Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
Intervention: Bexarotene
Trial phase: Not Applicable
ATC code: L01XF03 | L01XX25
SMILES: C=C(c1ccc(C(=O)O)cc1)c1cc2c(cc1C)C(C)(C)CCC2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.

erlotinib (Tarceva) and bexarotene (Targretin): Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy
Eligibility criteria:
Inclusion Criteria:

Resectable stage I or II non-small-cell lung cancer
Prior tissue biopsy (not cytology) available for research analysis
Adequate hepatic and renal function

Exclusion Criteria:

Prior chemotherapy or radiotherapy
Intervention: Atenolol
Trial phase: Not Applicable
ATC code: C07AB03 | C07BB03 | C07CB03 | C07CB53 | C07DB01 | C07FB03
SMILES: CC(C)NCC(O)COc1ccc(CC(N)=O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: atenolol 25mg daily

Atenolol: Atenolol 25mg daily
Eligibility criteria:
Inclusion Criteria:

Males or females aged 18 or above
Blood pressure that meets any of the three following criteria:
BP should be <140/85 mmHg on a maximum of two anti-hypertensive drugs

Exclusion Criteria:

contraindications to beta-blockade
contraindications to thiazide use
if there was a history of asthma, diabetes, heart failure, bradycardia, atrial fibrillation, AV conduction disturbances
concurrent treatment with verapamil & dilitiazem
childbearing women
compelling indication for treatment with a beta blocker
any condition that will interfere with the treatment or the patient's ability to complete the study