anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ivabradine
Trial phase: Not Applicable
ATC code: C01EB17 | C07FX05 | C07FX06
SMILES: COc1cc2c(cc1OC)CC(=O)N(CCCN(C)C[C@H]1Cc3cc(OC)c(OC)cc31)CC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Subjects are given an ivabradine capsule (double-blinded) to take 90 minutes prior to the cardiopulmonary exercise test.

Ivabradine: Ivabradine 7.5mg
Eligibility criteria:
Inclusion criteria:

We will only include patients able to give informed written consent, which will be obtained in all subjects, and those capable of performing a peak exercise test. Since we are performing the study on three groups of patients, further inclusion criteria for each group are outlined below.

Inclusion criteria - CRT-sinus rhythm group We will enrol 25 patients with severe CHF on otherwise optimally tolerated medical therapy who have undergone cardiac resynchronisation therapy at least 3 months previously. These individuals will be on optimal medical therapy for their heart failure with no change in medication or exacerbation for the preceding 3 months. They will not currently be taking ivabradine.

Inclusion criteria - CRT-atrial fibrillation group We will enrol 25 patients with severe CHF on otherwise optimally tolerated medical therapy who have undergone cardiac resynchronisation therapy at least 3 months previously. All patients will be previously pacemaker dependant or have 'blocked' atrial fibrillation either due to medical therapy or previous atrio-ventricular nodal ablation.

Inclusion criteria - control group The control subjects (n=25) will be recruited from the general pacemaker clinic. They will undergo echocardiography to exclude structural heart disease. They will have no contraindications to exercise testing or ivabradine.

Exclusion Criteria:

We will exclude subjects with musculoskeletal disorders limiting exercise capacity, patients with peripheral vascular disease, those with inflammatory disorders such as rheumatoid arthritis, and airways disease. Other exclusions include contraindications to ivabradine use such as severe hepatic impairment, significant renal impairment (creatinine clearance <15ml.min-1), and long QT syndrome. We will only include patients able to give informed written consent, which will be obtained in all subjects.

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Intervention: Sirolimus
Trial phase: Phase 3
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: 60
Group description: Medium dose of DE-109

DE-109: Medium Dose of DE-109
Eligibility criteria:
Inclusion Criteria:

Participated in the SAKURA study
Received clinical benefit from treatment in the SAKURA study
Ability to sign informed consent and attend all study visits

Exclusion Criteria:

Uveitis of infectious etiology
Implanted device
Suspected or confirmed central nervous system or ocular lymphoma
Uncontrolled glaucoma
Significant ocular disease
Intravitreal injections in the past 60 days
Intraocular surgery or treatment
Ocular or periocular infection
History of herpetic infection
Toxoplasmosis or toxoplasmosis scar
Ocular malignancy
Vitrectomy
Allergy or hypersensitivity to study drug
Participation in other uveitis device clinical trials within 30 days
Any recent systemic condition/infection
Immunosuppressive therapy or immunocomprimised
Cytomegalovirus infection
Malignancy in remission
Females who are pregnant or lactating and who are not using adequate contraceptive
Medical marijuana or illegal drug use
Systemic saroidosis
Therapeutic radiation to the head or neck
Intervention: Metformin
Trial phase: 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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: 500 to 1500 mg orally per day for 16 weeks if eGFR > 45 ml/min; 500 to 1000 mg orally per day for 16 weeks if eGFR =< 45 ml/min

metformin: 500 to 1500 mg orally per day for 16 weeks if eGFR > 45 ml/min; 500 to 1000 mg orally per day for 16 weeks if eGFR =< 45 ml/min
Eligibility criteria:
Inclusion Criteria:

Age 18 years old;
Ability to give informed consent;
Life expectancy greater than 6 months;
Estimated GFR 30-59 ml/min/1.73m^2;
Overweight (BMI >=25 to < 30 kg/m^2) or obese (BMI >=30 kg/m^2); or normal (BMI >=18.5 to <25 kg/m^2) if pre-diabetic or insulin resistant.

Exclusion Criteria:

Pregnancy or breast feeding;
Presence or history of Diabetes Mellitus type I or II
History of metformin use or any insulin sensitizer or any drug for the treatment of metabolic syndrome over the last one year;
Any acute kidney injury episode in the last 4 months due to the risk of recurrent AKI;
Proteinuria of > 5 g in 24 hours determined by a 24 hour urine collection or PCR > 4.5;
Uncontrolled hypertension with systolic blood pressure 160 mmHg and diastolic blood pressure 100 mmHg;
Patients with new changes to their antihypertensive regimen over the last 1 month;
Severe, unstable, or active inflammatory disease; active infection including seropositive HIV, Hepatitis B or C; active connective tissue disorder; or moderate to severe liver disease;
Decompensated heart failure;
Recent hospitalization or surgical procedure within 1 month prior to the study for any cause;
Current active malignancy or cancer history in the prior 5 years (excluding squamous cell and basal cell skin cancers);
Known intolerance to the study drug;
Patient receiving oral or injected steroids
Use of any investigational product or device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments;
Intervention: Abemaciclib
Trial phase: Phase 1
ATC code: L01EF03
SMILES: CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: Single oral dose of 200 mg LY2835219 Day 1, period 1.
Eligibility criteria:
Inclusion Criteria:

Overtly healthy sterile males or surgically sterile females or postmenopausal females
Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2)

Exclusion Criteria:

Have participated in a clinical trial involving investigational product within the last 30 days
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have an abnormal blood pressure
Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
Have donated blood of more than 500 milliliters (mL) within the last month
Have used or intend to use over-the-counter or prescription medication including herbal medications within 7 days prior to dosing or during the study
Intervention: Rocuronium
Trial phase: Phase 2
ATC code: M03AC09
SMILES: [H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 83
Group description: Patients will receive a bolus dose of 1 mg/kg, then a continuous I.V. infusion as per standard intensive care unit practice.

Of note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).

Rocuronium: Neuromuscular Blockade
Eligibility criteria:
Inclusion Criteria:

Adult (≥ 18 years)
Cardiac arrest with sustained return of spontaneous circulation (ROSC)
Comatose (i.e., not following commands) following ROSC
Undergoing targeted temperature management (TTM)
Time of enrollment ≤ 6 hours from initiation of targeted temperature management
Serum Lactate ≥2

Exclusion Criteria:

Pre-existing dementia, severe brain injury, or dependence on others for activities of daily living (i.e. a modified Rankin scale (mRS) score of 4 or higher)
Traumatic etiology of the cardiac arrest
Protected population (pregnant, prisoner)
Intervention: Naropin
Trial phase: Phase 3
SMILES: CCC[NH+]1CCCCC1C(=O)Nc1c(C)cccc1C.O.[Cl-]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline

ropivacaine infiltration: wound infiltration
Eligibility criteria:
Inclusion Criteria:

Patients aged 18 years and more, ASA 1 or ASA 2, pregnant with at least 34 weeks of gestational age, admitted for a planned caesarian with a Pfannenstiel incision and having signed the informed consent form.

Exclusion Criteria:

Refusal of the patient or contra-indication to locoregional anesthesia
Allergy to the products used
ASA 3
ASA 4
Sleep apnea syndrome and/or obesity (BMI > 35)
Size inferior to 155cm
existence of a language barrier
Intervention: Acetaminophen
Trial phase: Not Applicable
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: 80
Group description: Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.

Patient and family received standard education on concussion management in the Emergency department.

Acetaminophen: routine administration of medication for a 72 hour period
Eligibility criteria:
Inclusion Criteria:

diagnosed with a first time concussion
english speaking
presenting to Emergency with headache 24-48 hours post concussion
normal Glascow Coma Scale
8-18 years of age

Exclusion Criteria

postive findings on CT scan
patient with cervical injury
history of multiple concussions
positive neurology
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: Child
Healthy volunteers: No
Participants at risk: 166
Group description: 8-10.99 year old children received metformin. Initially children were given 250mg of metformin daily for a week and increased to 250mg twice daily for a week and then to 500 mg twice daily there after. 11-16 year old children received 500mg of metformin daily initially for one week increased to 500mg twice daily for a week and then to 1g twice daily.

Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia. Effects to medication were evaluated before each dose revision and was monitored for all possible adverse events.
Eligibility criteria:
Inclusion Criteria:

Obese children (based on >+2SD of BMI to age on WHO 2007 standards)

Exclusion Criteria:

Children not of Sri Lankan origin
Children who are not planning to live in Sri Lanka during the next one year
Children with a secondary underlying cause for the overweight/obesity
Intervention: Bictegravir
Trial phase: Phase 1
ATC code: J05AR20
SMILES: O=C(NCc1c(F)cc(F)cc1F)c1cn2c(c(O)c1=O)C(=O)N1[C@H]3CC[C@H](C3)O[C@@H]1C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Bictegravir 5 mg (1 × 5 mg tablet) administered orally once daily for 10 days
Eligibility criteria:
Key Inclusion Criteria:

No current or prior anti-HIV treatment, including ART medications received for prevention (preexposure prophylaxis [PrEP]), or postexposure prophylaxis (PEP) within 12 weeks of screening
Plasma HIV-1 ribonucleic acid (RNA) ≥ 10,000 copies/mL but ≤ 400,000 copies/mL at screening
Cluster of differentiation 4+ (CD4+) cell count > 200 cells/mm^3

Key Exclusion Criteria:

Anticipated to start HIV-1 therapy during the study period
Active participation in another study of investigational or approved ART agents
A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
Participants with positive hepatitis C antibody at screening
Chronic hepatitis B virus (HBV) infection
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 42 days prior to Day 1 (baseline)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Bictegravir
Trial phase: Phase 1
ATC code: J05AR20
SMILES: O=C(NCc1c(F)cc(F)cc1F)c1cn2c(c(O)c1=O)C(=O)N1[C@H]3CC[C@H](C3)O[C@@H]1C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Bictegravir 25 mg (1 × 25 mg tablet) administered orally once daily for 10 days
Eligibility criteria:
Key Inclusion Criteria:

No current or prior anti-HIV treatment, including ART medications received for prevention (preexposure prophylaxis [PrEP]), or postexposure prophylaxis (PEP) within 12 weeks of screening
Plasma HIV-1 ribonucleic acid (RNA) ≥ 10,000 copies/mL but ≤ 400,000 copies/mL at screening
Cluster of differentiation 4+ (CD4+) cell count > 200 cells/mm^3

Key Exclusion Criteria:

Anticipated to start HIV-1 therapy during the study period
Active participation in another study of investigational or approved ART agents
A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
Participants with positive hepatitis C antibody at screening
Chronic hepatitis B virus (HBV) infection
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 42 days prior to Day 1 (baseline)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Bictegravir
Trial phase: Phase 1
ATC code: J05AR20
SMILES: O=C(NCc1c(F)cc(F)cc1F)c1cn2c(c(O)c1=O)C(=O)N1[C@H]3CC[C@H](C3)O[C@@H]1C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Bictegravir 50 mg (2 × 25 mg tablets) administered orally once daily for 10 days
Eligibility criteria:
Key Inclusion Criteria:

No current or prior anti-HIV treatment, including ART medications received for prevention (preexposure prophylaxis [PrEP]), or postexposure prophylaxis (PEP) within 12 weeks of screening
Plasma HIV-1 ribonucleic acid (RNA) ≥ 10,000 copies/mL but ≤ 400,000 copies/mL at screening
Cluster of differentiation 4+ (CD4+) cell count > 200 cells/mm^3

Key Exclusion Criteria:

Anticipated to start HIV-1 therapy during the study period
Active participation in another study of investigational or approved ART agents
A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
Participants with positive hepatitis C antibody at screening
Chronic hepatitis B virus (HBV) infection
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 42 days prior to Day 1 (baseline)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Intervention: Bictegravir
Trial phase: Phase 1
ATC code: J05AR20
SMILES: O=C(NCc1c(F)cc(F)cc1F)c1cn2c(c(O)c1=O)C(=O)N1[C@H]3CC[C@H](C3)O[C@@H]1C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Bictegravir 100 mg (1 × 100 mg tablet) administered orally once daily for 10 days
Eligibility criteria:
Key Inclusion Criteria:

No current or prior anti-HIV treatment, including ART medications received for prevention (preexposure prophylaxis [PrEP]), or postexposure prophylaxis (PEP) within 12 weeks of screening
Plasma HIV-1 ribonucleic acid (RNA) ≥ 10,000 copies/mL but ≤ 400,000 copies/mL at screening
Cluster of differentiation 4+ (CD4+) cell count > 200 cells/mm^3

Key Exclusion Criteria:

Anticipated to start HIV-1 therapy during the study period
Active participation in another study of investigational or approved ART agents
A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
Participants with positive hepatitis C antibody at screening
Chronic hepatitis B virus (HBV) infection
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 42 days prior to Day 1 (baseline)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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: 10
Group description: This group consists of stable but febrile ICU patients (temp >38.3°C). Participants in this group will receive a one-time does of acetaminophen 650mg via the enteral route (via the gut), after which vital signs (including continuous measures of core temperature, heart rate, and blood pressure) will be monitored for 4 hours.

Acetaminophen: one-time dose of acetaminophen 650mg given via the enteral route (via the gut)
Eligibility criteria:
Generally to be considered for this study one must be critically ill, febrile, and can safely either receive acetaminophen or have acetaminophen withheld. Also one must not have conditions that would alter normal drug absorption or normal thermoregulation. Specifically the eligibility criteria are:

INCLUSION CRITERIA:

Adult patients (> 18 years) admitted to Intensive Care Unit at Vancouver Hospital with a core temperature > 38.3 °C for 2 or more consecutive hours, but not longer than 48 hours*
Continuous arterial pressure monitor in place at the time of intervention and data collection
Patients may only participate in the study once
To remain in the ICU for the entire study period (2 hours prior to drug administration to 4 hours post drug administration)

EXCLUSION CRITERIA:

Significant liver dysfunction
Acute neurological injury
Seizure disorder
Cardiomyopathy, elevated cardiac enzymes indicative of an acute cardiac injury, electrocardiogram (ECG) changes indicative of cardiac ischemia (i.e., ST segment elevation/depression)
Hemodynamic instability (requiring fluid boluses, or change/initiation of vasopressors. Patients receiving steady doses of vasopressor support may be included)
Severe hypoxemia, (fraction of inspired oxygen (FiO2) requirements of more than 60% to maintain hemoglobin oxygen saturation (SaO2) > 90% or partial pressure of oxygen in the blood (PaO2) > 70)
Temperature > 40.0 °C
Receiving external cooling
Haemodialysis, plasma exchange, or any treatment where the blood is taken out of the body and processed
Acute thermal injury to skin (i.e., burn)
Gut malabsorption (i.e., receiving < 40% required calories enterally)
Receiving medications that have known antipyretic effects (acetaminophen, ibuprofen, steroids, etc.)
Physician opposed to enrolment in the study

NOTE: in response to very low enrollment 2 exclusion criteria were changed on Nov 5, 2015. These were:

patients no longer needed to recieve 40% of required calories enterally, instead patients who were not receiving any caloric intake via the gut could be enrolled as long as they were still permitted to receive oral medications.
patients no longer had to have acetaminophen discontinued upon enrollment. They could not be receiving it regularly but could still receive acetaminophen on an as needed (PRN) basis as long as it could be safely withheld for up to 12 hours if they developed a fever.
Intervention: Aminolevulinic Acid Hydrochloride
Trial phase: Phase 2
SMILES: Cl.NCC(=O)CCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: 20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment

Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light

BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
Eligibility criteria:
Inclusion Criteria:

At least 6 Grade 1/2 AKs on one upper extremity AND
At least 12 Grade 1/2 AKs on the OTHER upper extremity

Exclusion Criteria:

Pregnancy
history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
Body Mass Index (BMI) > 32.0 kg/m2
skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
significant blood loss within 60 days or donated blood/plasma within 72 hours prior to Visit 2 (Baseline)
tested positive at screening for human immunodeficiency virus (HIV) or was known to be seropositive for HIV
a history of lead poisoning or a history of a significant exposure to lead or a screening lead level above 6μg/dl
tested positive at screening for hepatitis B surface antigen, hepatitis C antibody or had a history of a positive result
positive drug screen at Screening
Screening safety labs are clinically significant in the opinion of the investigator
major surgery within 30 days prior to Visit 2 (Baseline) or plans to have surgery during the study
Subject is immunosuppressed
currently enrolled in an investigational drug or device study
has received an investigational drug or been treated with an investigational device within 30 days prior to Visit 2 (Baseline)
known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)

use of the following topical preparations on the extremities to be treated:

Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days of initiation of treatment
Cryotherapy within 2 weeks of initiation of treatment
Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of initiation of treatment
Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment
use of systemic retinoid therapy within 6 months of initiation of treatment