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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: IV ibuprofen

Ibuprofen: 800 mg ibuprofen in 250 cc saline administered IV
Eligibility criteria:
Inclusion Criteria:

Male and female subjects between the ages of 18 and 65, inclusive
Subject diagnosed with episodic migraine, with or without aura according to ICHD-2 criteria for at least one-year prior to screening
Subject experiences between 2-10 migraine attacks per month (during the previous 6 months) with no more than 15 days of headache per month.
Subject is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female and of child-bearing potential
Subject is able to come for 4 hour in-clinic treatment of an acute migraine attack
Subjects are able to understand and comply with all study procedures.
Subject provides written informed consent prior to any screening procedures being conducted
If subject is on an allowable migraine preventive medication, the dose has been stable for at least 4 weeks prior to screening and the dose will remain stable throughout study participation.

Exclusion Criteria:

Unable to make a reliable self-report of pain intensity to pain relief
Use of analgesic or opioid within 24 hours of onset of headache to be treated with study medication. (If subject has an eligible headache and has taken a triptan or DHE within 24 hours, but greater than 2 hours before study drug dosing, they can be treated with study medication.)
Patients taking the following medications on a regular basis: warfarin, lithium, ACE-inhibitors, loop diuretics, thiazide diuretics, ARBs, and methotrexate.
Patients with active, clinically significant anemia
Patients with a history or evidence of asthma
Patients with a history heart failure
Subjects with severely impaired hepatic or renal function, as determined by the investigator
Patients with a history of allergy or hypersensitivity to any component of IVIb, aspirin (or aspirin related products), NSAIDs, or COX-2 inhibitors
Pregnant or nursing women
Patients who have a history of congenital bleeding diathesis (e.g., hemophilia) or any active clinically significant bleeding, or have underlying platelet dysfunction including (but not limited to) idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, or congenital platelet dysfunction
Patients who have GI bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed.)
Patients who have a platelet count less than 100,000, as determined within the 28 days prior to treatment
Pre-existing or current dependence on opioids.
Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit
Subjects with uncontrolled hypertension
Intervention: Nebivolol
Trial phase: Phase 4
ATC code: C07AB12 | C07BB12 | C07FB12 | C09DX05
SMILES: OC(CNCC(O)C1CCc2cc(F)ccc2O1)C1CCc2cc(F)ccc2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Nebivolol: 10 mg PO qday
Eligibility criteria:
Inclusion Criteria:

Patients with stable angina or acute coronary syndrome
Moderate coronary lesion (defined as a lesion significant enough by the treating physician to warrant further evaluation using CFR or FFR or intravascular ultrasound assessment).
Lesion located in the proximal 60mm of the RCA or LAD.
On stable medical therapy for other cardiac risk factors.

Exclusion Criteria:

Left Main lesion greater than 50% stenosis
Patients with a history of coronary artery bypass surgery
Severe valvular heart disease
Patients presenting with a STEMI.
Inability to provide informed consent prior to randomization
Creatinine >1.5
Lesions located beyond 60mm in an epicardial vessel
Coronary anatomy requiring CABG
B-blocker, calcium channel blocker or extended-release nitrate therapy within last 48 hours.
Bradycardia (HR<50 bpm)
Hypotension (SBP<100mmHg)
Severe COPD by pulmonary function testing
Intervention: Atenolol
Trial phase: Phase 4
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: 29
Group description: Atenolol: 100 mg PO qday
Eligibility criteria:
Inclusion Criteria:

Patients with stable angina or acute coronary syndrome
Moderate coronary lesion (defined as a lesion significant enough by the treating physician to warrant further evaluation using CFR or FFR or intravascular ultrasound assessment).
Lesion located in the proximal 60mm of the RCA or LAD.
On stable medical therapy for other cardiac risk factors.

Exclusion Criteria:

Left Main lesion greater than 50% stenosis
Patients with a history of coronary artery bypass surgery
Severe valvular heart disease
Patients presenting with a STEMI.
Inability to provide informed consent prior to randomization
Creatinine >1.5
Lesions located beyond 60mm in an epicardial vessel
Coronary anatomy requiring CABG
B-blocker, calcium channel blocker or extended-release nitrate therapy within last 48 hours.
Bradycardia (HR<50 bpm)
Hypotension (SBP<100mmHg)
Severe COPD by pulmonary function testing
Intervention: FLUTICASONE PROPIONATE
Trial phase: Not Applicable
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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: inhalation of 250 mcg of fluticasone

fluticasone: 220- mcg once
Eligibility criteria:
Inclusion Criteria:

Males and females, 18 to 65 years of age.
FEV1 60-85% of predicted on the screening day. -

Exclusion Criteria:

1. Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women. 2. Cardiovascular disease and/or use of cardiovascular medications 3. Subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance 4. Acute respiratory infection within four weeks prior to the study 5. Use, within two weeks prior to the study, of any anti-asthma medication not mentioned above

-
Intervention: Salmeterol
Trial phase: Not Applicable
ATC code: R03AC12 | R03AK06 | R03AK12
SMILES: OCc1cc(C(O)CNCCCCCCOCCCCc2ccccc2)ccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: inhalation of salmeterol 50 mcg once

Salmeterol: 50 mcg salmeterol once

Salmeterol: 50 mcg once
Eligibility criteria:
Inclusion Criteria:

Males and females, 18 to 65 years of age.
FEV1 60-85% of predicted on the screening day. -

Exclusion Criteria:

1. Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women. 2. Cardiovascular disease and/or use of cardiovascular medications 3. Subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance 4. Acute respiratory infection within four weeks prior to the study 5. Use, within two weeks prior to the study, of any anti-asthma medication not mentioned above

-
Intervention: Viani
Trial phase: Not Applicable
SMILES: CCC(=O)OC1(C(=O)SCF)C(C)CC2C3CC(F)C4=CC(=O)C=CC4(C)C3(F)C(O)CC21C.OCc1cc(C(O)CNCCCCCCOCCCCc2ccccc2)ccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: inhalation of fluticasone 250mcg combined with salmeterol 50 mcg

fluticasone/salmeterol: inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol
Eligibility criteria:
Inclusion Criteria:

Males and females, 18 to 65 years of age.
FEV1 60-85% of predicted on the screening day. -

Exclusion Criteria:

1. Women of childbearing potential who do not use accepted birth control measures; pregnant and breast feeding women. 2. Cardiovascular disease and/or use of cardiovascular medications 3. Subjects with known beta-adrenergic agonist or glucocorticosteroid intolerance 4. Acute respiratory infection within four weeks prior to the study 5. Use, within two weeks prior to the study, of any anti-asthma medication not mentioned above

-
Intervention: Dapsone
Trial phase: Phase 4
ATC code: D10AX05 | J04BA02 | J04BA50 | J04BA51
SMILES: Nc1ccc(S(=O)(=O)c2ccc(N)cc2)cc1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 136
Group description: Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Severe facial acne (acne vulgaris)

Exclusion Criteria:

History of significant anemia or hemolysis
History of enteritis (eg, regional enteritis, ulcerative colitis, pseudomembranous colitis, antibiotic-associated colitis)
History of lupus, rosacea, or seborrheic dermatitis
Intervention: DUAC gel
Trial phase: Phase 4
SMILES: CCCC1CC(C(=O)NC(C(C)Cl)C2OC(SC)C(OP(=O)(O)O)C(O)C2O)N(C)C1.O=C(OOC(=O)c1ccccc1)c1ccccc1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 135
Group description: Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Severe facial acne (acne vulgaris)

Exclusion Criteria:

History of significant anemia or hemolysis
History of enteritis (eg, regional enteritis, ulcerative colitis, pseudomembranous colitis, antibiotic-associated colitis)
History of lupus, rosacea, or seborrheic dermatitis
Intervention: FLUTICASONE FUROATE
Trial phase: Phase 3
ATC code: R01AD12 | R03AK10 | R03AL08 | R03BA09
SMILES: [H][C@@]12C[C@@H](C)[C@](OC(=O)c3ccco3)(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 | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 181
Group description: Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
Eligibility criteria:
Inclusion Criteria:

Subjects can be enrolled when meeting all criteria as below.

Chinese adolescent and adult (male or eligible female) outpatients with the age of >=12 years
Confirmative diagnosis of IAR or PER (as definitions from ARIA 2008 and the coming effective Chinese AR management guideline ), by medical history, symptoms, skin prick tests (SPTs)
Subject must be symptomatic at screening and willing to maintain same environment throughout the study
Ability to comply with study procedures
Literate

Exclusion Criteria:

Subjects should be excluded when meeting one of criteria as below.

Having complications of nasal disease, or vasomotor rhinitis, rhinitis with eosinophilia, or drug rhinitis
Having complications of bacterial/viral infection of upper respiratory tract
Having significant systemic diseases
History of hypersensitivity to steroids and ingredients
Pregnant women or under lactation
Patients who started, discontinued or changed dose of desensitization therapy within 30 days before visit 1
Patients planning to travel outside the region
Patients judged to be inappropriate by investigators
Patients who participated in another study within 4 months before screening

Patients who could not withdraw drugs during screening period or secure withdrawal period until the initiation day of administration, e.g.

allergy medications
other medications that may affect allergic rhinitis or its symptoms
any medications that significantly inhibit CYP3A4, including ritonavir and ketoconazole
Intervention: Capsaicin
Trial phase: Phase 3
ATC code: M02AB01 | M02AB02 | N01BX04
SMILES: COc1cc(CNC(=O)CCCC/C=C/C(C)C)ccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
Eligibility criteria:
Inclusion Criteria:

> or = 3 month history of chronic, stable, angina triggered by physical effort or mental/emotional stress
documented stress-induced ST depression, reversible perfusion imaging, or wall motion abnormality or CAD >50%
Canadian Cardiovascular (CV) Class I-III
Receiving medical therapy for > or = 2 months
Ability to perform Bruce Protocol treadmill test
non-pregnant female

Exclusion Criteria:

unstable angina
revasc within 2 months
Myocardial infarction (MI) within 2 months
congestive heart failure (CHF) hospitalization within 2 months
New York Heart Association (NYHA) class III or IV
left ventricular ejection fraction (LVEF) < 25%
abnormal ECG; Acute changes on ECG
Currently receiving treatment with investigational drugs/devices
Uncontrolled hypertension
contraindication to exercise stress testing
allergy to red peppers or capsaicin
skin deformity, scar, or rash at application site
abdominal surgery within 3 months
Intervention: Cyclosporine
Trial phase: Phase 2
ATC code: L04AD01 | S01XA18
SMILES: CC=CCC(C)C(O)C1C(=O)NC(CC)C(=O)N(C)CC(=O)N(C)C(CC(C)C)C(=O)NC(C(C)C)C(=O)N(C)C(CC(C)C)C(=O)NC(C)C(=O)NC(C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(C(C)C)C(=O)N1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Patients receive anti-thymocyte globulin IV daily over 4-24 hours on days 1-5. Beginning on day 6, patients receive oral cyclosporine twice daily for 6 months followed by a taper. Treatment continues in the absence of disease progression or unacceptable toxicity
Eligibility criteria:
Inclusion Criteria:

All patients with sAA as defined by Camitta who are candidates for IS therapy; these criteria include bone marrow cellularity < 25% or 25-50% with < 30% of hematopoietic cells; it should also have two of the following three parameters: peripheral blood neutrophils < 0.5 x 10^9/L, platelets < 20 x 10^9/L and reticulocytes < 60 x 10^9/L in anemic patients
If cytogenetic testing has been done, it should show normal karyotype or be not informative
Patients should be either unwilling or otherwise ineligible (age, comorbidities, lack of donor) for bone marrow transplantation as a therapeutic modality
Not previously treated with ATG for sAA
Patients must have ECOG performance status of 0, 1, or 2
Vitamin B12 and folic acid deficiency must be ruled out by measurement of serum levels
Patients must have had a bone marrow biopsy examination in the three months prior to enrolling in the study
Must be able to provide informed consent
Systemic and other hematologic causes of pancytopenia, based on clinical presentation, must have been ruled out

Exclusion Criteria:

Patients with clinically evident congestive heart failure, serious cardiac arrhythmias; symptoms of coronary artery disease must be cleared by cardiology prior to therapy
Patients who have had chemotherapy, radiotherapy, or immunotherapy or other investigational drug use within 3 weeks prior to study entry
Pregnant women
All females of childbearing potential must have a blood test or urine study within two weeks prior to induction registration to rule out pregnancy
Women of childbearing potential are strongly advised to use an accepted and effective method of contraception
Patients who have medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Intervention: Rasagiline
Trial phase: Phase 2
ATC code: N04BD02
SMILES: C#CCN[C@@H]1CCc2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Treated for 12 months with rasagiline 2mg orally, once daily.

rasagiline: rasagiline 2 mg daily for 12 months
Eligibility criteria:
Inclusion Criteria:

A clinical diagnosis of laboratory-supported probable, probable, or definite ALS, according to a modified El Escorial criteria, by the study investigator (Appendix IV).
21 to 80 years of age inclusive.
VC greater or equal to 75% of predicted at screening and baseline.
Onset of weakness within 3 years prior to enrollment.
If patients are taking riluzole for ALS, they must be on a stable dose for at least thirty days prior to the baseline visit.
Women of childbearing age must be non-lactating and surgically sterile or using an effective method of birth control and have a negative pregnancy test.
Willing and able to give signed informed consent that has been approved by the Institutional Review Board (IRB).

Exclusion criteria

Requirement for tracheotomy ventilation or non-invasive ventilation for > 23 hours per day.
Patients on sympathomimetic agents. This includes pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine.
Patients on analgesics with serotoninergic properties such as meperidine, tramadol, methadone and propoxyphen, flexeril.
Patients on fluoxetine or fluvoxamine.
Patients taking amitriptyline > 50 mg/d, trazodone and sertraline > 100 mg/d, citalogram > 20 mg/d or paroxetine > 30 mg/d.
Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc).
Clinically significant history of unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days.
History of renal disease.
History of liver disease.
Current pregnancy or lactation.
Limited mental capacity such that the patient cannot provide written informed consent or comply with evaluation procedures.
History of recent alcohol or drug abuse or noncompliance with treatment or other experimental protocols.
VC < 75% of predicted.
Receipt of any investigational drug within the past 30 days.
Women with the potential to become pregnant who are not practicing effective birth control.
Intervention: Indacaterol
Trial phase: Phase 3
ATC code: R03AC18 | R03AK14 | R03AL04 | R03AL12
SMILES: CCc1cc2c(cc1CC)CC(NC[C@H](O)c1ccc(O)c3[nH]c(=O)ccc13)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: indacaterol 150 µg once-daily via single-dose dry powder inhaler
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
Post-bronchodilator forced expiratory volume in 1 second (FEV1) <80% and ≥30% of the predicted normal value
Post-bronchodilator FEV1/FVC (Forced Vital Capacity) <70%
Current COPD bronchodilator treatment that includes a LABA bronchodilator or a fixed dose combination of LABA and Inhaled Corticosteroid (ICS)

Exclusion Criteria:

Patients with a history of asthma
Patients who are currently being treated for COPD with tiotropium (Spiriva®)
Patients with diabetes Type I or uncontrolled diabetes Type II
Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: MYCOPHENOLATE MOFETIL
Trial phase: Phase 3
SMILES: COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)OCCN1CCOCC1)C(=O)OC2
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
Eligibility criteria:
Inclusion Criteria:

Non-infectious anterior, intermediate, posterior or panuveitis
Active uveitis within the last 60 days (defined by the presence of any of the following according to SUN criteria: ≥ 1+ anterior chamber cells, anterior vitreous cells, vitreous haze, active retinal or choroidal lesions)
Prednisone dose ≥ 15 mg/day
History of corticosteroid taper failure (inability to taper to prednisone 10 mg or less) or obvious chronic disease necessitating corticosteroid-sparing immunosuppressive treatment

Exclusion Criteria:

Any infectious cause of uveitis
Tuberculosis: Evidence of active TB (PPD and CXR required - latent TB patients are still eligible)
Positive for Hepatitis: HBsAg and/or Hep C antibody
Positive for Syphilis: RPR/VDRL and/or FTA-ABS
Abnormal CBC (<2500 WBC or <75,000 Plts or <10 Hgb)
Abnormal liver and/or kidney tests (ALT/AST >2x normal or CR>1.5)
Pregnancy or breast-feeding (blood or urine pregnancy test for all females, excluding those who are post-menopausal)
Chronic hypotony (IOP < 5 mm Hg for > 3 months)
Prior use of any immunosuppressive drug for the treatment of uveitis in the past 6 months
Prior failed treatment with methotrexate or mycophenolate mofetil
Periocular or intravitreal corticosteroid injection in the past 3 months
Fluocinolone acetonide implant surgery in either eye in < 3 years
Intraocular surgery in < 30 days, or any ocular surgery scheduled during the 6-month study period
VA of hand motions or worse in better eye
< 16 years of age at enrollment
Intervention: Victoza
Trial phase: Not Applicable
ATC code: A10BJ02
SMILES: CCCCCCCCCCCCCCCC(=O)NC(CCC(=O)NCCCCC(NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(N)=O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1ccccc1)C(=O)NC(C(=O)NC(C)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)O)C(C)C)C(C)CC)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.

liraglutide: 1.8mg subcutaneous qd for 3 months
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetic
18-50 years
BMI > 25kg/m2
HbA1c 7.0-10.0%
Treated with up to 2 oral agents

Exclusion Criteria:

Chronic illness or infection (other than diabetes mellitus)
Known coronary artery disease, structural heart disease or abnormal ECG on screen.
Treatment with >2 antihypertensive agents or blood pressure >140/95 on two occasions during screening
History of claustrophobia, musculoskeletal or other factors which would result in an inability to comfortably remain within the PET scanner gantry for the duration of the imaging protocol.
Occupational, investigational or other known radiation exposure which together with the planned radiologic studies, will result in greater than 500 mrem total exposure in a 12 month period.
Current pregnancy
Treatment with GLP-1 agonist or DPP4 inhibitor within the past 6 months
Known intolerance to GLP-1 agonist
Personal history of pancreatitis, personal or family history of medullary thyroid carcinoma, or other contraindications to liraglutide treatment.
Recognized microvascular complications (neuropathy, nephropathy, retinopathy).