anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Hydrocortisone
Trial phase: Not Applicable
ATC code: A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 58
Group description: Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
Eligibility criteria:
Inclusion Criteria:

age 18 years old or older;
onset of septic shock within 6 h

Exclusion Criteria:

Systemic corticosteroid therapy within the last 3 months before septic shock;
high-dose steroid therapy;
immunosuppression;
refusal of the attending staff or patient family.
Intervention: Naloxone
Trial phase: Phase 2 | Phase 3
ATC code: A06AH04 | N02AA53 | N02AA55 | N02AX51 | V03AB15
SMILES: C=CCN1CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 199
Group description: Naloxone 8-mg IV given once after baseline ABG

Naloxone: Naloxone 8-mg IV bolus
Eligibility criteria:
Inclusion Criteria:

Brain-dead organ donor being managed by OPO (organ procurement organization)
Lungs being considered for recovery and transplant
Baseline ABG (after authorization) with P/F ratio < 300

Exclusion Criteria:

No authorization for research
Lungs already excluded for transplant (e.g. known chronic obstructive pulmonary disease [COPD], human immunodeficiency virus [HIV] infection)
Intervention: Ethephon
Trial phase: Phase 4
SMILES: O=P(O)(O)CCCl
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 136
Group description: All participants will be assigned to this arm of the study.

Text Messaging: All participants assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.

Adherence Counseling: All participants assigned to the counseling intervention will receive sexual health and medication adherence counseling at each study visit. Participants with suboptimal adherence (TFV-DP levels of <1050 fmol/punch (representing fewer than mean 6-7 daily doses per week)) will trigger a targeted iNSC session. Participants with two TFV-DP levels of <1050 fmol/punch will trigger PrEP Steps, a higher intensity adherence counseling intervention consisting of four 50-minute counseling sessions and 2 booster counseling sessions.

Daily Oral PrEP: All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis.
Eligibility criteria:
Inclusion Criteria:

Female at birth and identifies as female gender
Age 18 years or older
Able to understand and provide consent in English or Spanish
HIV negative by 4th generation test (Ag/Ab test) or combination of enzymeimmunoassay (EIA) and HIV RNA
Creatinine clearance ≥ 60 ml/min (via Cockcroft-Gault formula)

At-Risk Criteria (at least one):

Condomless sex in the last 3 months with one or more male partners of unknown HIV status known to be at substantial risk of HIV infection (IDU, bisexual, sex for goods, recently incarcerated, from a country with HIV prevalence >1%, interpersonal Partner Violence);
STI (rectal or vaginal gonorrhea or syphilis) diagnosis during the last 6 months.
Previous post-exposure prophylaxis (PEP) use during the last 12 months.
Has at least one HIV-infected sexual partner for ≥4 weeks.
Sex for exchange of money, goods or services

Exclusion Criteria:

Pregnancy at enrollment.
Any condition, which in the opinion of the provider, will seriously compromise the participant's ability to comply with the protocol, including adherence to PrEP medication dosing, such as active, untreated or unstable major mental illness (i.e. untreated psychotic disorder).
Use of prohibited medications, in particular, agents known to be nephrotoxic or drugs slow in renal excretion.
Previous participation in an HIV vaccine trial. Participants that were documented to have received only placebo are not excluded.
Signs or symptoms suspicious for Primary HIV Infection (PHI).
Intervention: Spironolactone
Trial phase: Phase 2 | Phase 3
ATC code: C03DA01
SMILES: [H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Spironolactone 100mg: 100mg/day of spironolactone (2 capsules), PO (oral) for 7 days

Spironolactone 100mg: 2 capsules of study medication consist of 100mg, PO (oral) for 7 days
Eligibility criteria:
Inclusion Criteria:

History of heart failure with either reduced or preserved ejection fraction for 3 months
Patients with New York Heart Association (NYHA) class II- IV heart failure symptoms, with at least one worsening symptom (Dyspnea on exertion, shortness of breath, orthopnea, early satiety) and one sign of congestion (pulmonary rales, elevated jugular venous pressure10cmHg, peripheral edema and ascites)
Decision by primary cardiologist or heart failure (HF) specialist to increase the home diuretic dose
Stable treatment with beta-blockers for 1 month unless contraindicated (i.e. intolerance, bradycardia) as specified by primary cardiologist/HF provider
Stable treatment with angiotensin converting enzyme-1 (ACE-1) or angiotensin receptor blocker (ARB) for 1 month
Spironolactone dose 25mg or eplerenone 50mg per day
Daily furosemide or furosemide equivalent dose of 80mg or greater
Serum potassium concentration 4.5 mmol/L or 5.0 mmol/L if on potassium supplements
Estimated Glomerular Filtration Rate (eGFR) by Modification of Diet in Renal Disease (MDRD) equation 40 ml/min/1.73

Exclusion Criteria:

Inability to complete informed consent form
Allergy or intolerance to spironolactone
Systolic blood pressure <100 mmHg
Patient in need of hospitalization per cardiologist decision
Current inotrope dependency
Current mechanical circulatory support
Acute coronary syndromes or unstable angina within the past 4 weeks
History of cardiac transplant
Obstructive cardiac valvular disease
Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy
Significant ventricular arrhythmia necessitating defibrillator therapy within the past 14 days
Atrioventricular conduction abnormality greater than first-degree block
Primary liver disease resulted in cirrhosis or abnormal liver function tests (transaminases and alkaline phosphatase levels 3 times the upper limit of normal
Acute malignancy
Active infection requiring antimicrobial treatment (Suppression antimicrobial for chronic infections are exempt)
Intervention: Spironolactone
Trial phase: Phase 2 | Phase 3
ATC code: C03DA01
SMILES: [H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Spironolactone 25mg: 25mg/day of spironolactone, PO (oral)

Spironolactone 25mg: 25mg/day of spironolactone
Eligibility criteria:
Inclusion Criteria:

History of heart failure with either reduced or preserved ejection fraction for 3 months
Patients with New York Heart Association (NYHA) class II- IV heart failure symptoms, with at least one worsening symptom (Dyspnea on exertion, shortness of breath, orthopnea, early satiety) and one sign of congestion (pulmonary rales, elevated jugular venous pressure10cmHg, peripheral edema and ascites)
Decision by primary cardiologist or heart failure (HF) specialist to increase the home diuretic dose
Stable treatment with beta-blockers for 1 month unless contraindicated (i.e. intolerance, bradycardia) as specified by primary cardiologist/HF provider
Stable treatment with angiotensin converting enzyme-1 (ACE-1) or angiotensin receptor blocker (ARB) for 1 month
Spironolactone dose 25mg or eplerenone 50mg per day
Daily furosemide or furosemide equivalent dose of 80mg or greater
Serum potassium concentration 4.5 mmol/L or 5.0 mmol/L if on potassium supplements
Estimated Glomerular Filtration Rate (eGFR) by Modification of Diet in Renal Disease (MDRD) equation 40 ml/min/1.73

Exclusion Criteria:

Inability to complete informed consent form
Allergy or intolerance to spironolactone
Systolic blood pressure <100 mmHg
Patient in need of hospitalization per cardiologist decision
Current inotrope dependency
Current mechanical circulatory support
Acute coronary syndromes or unstable angina within the past 4 weeks
History of cardiac transplant
Obstructive cardiac valvular disease
Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy
Significant ventricular arrhythmia necessitating defibrillator therapy within the past 14 days
Atrioventricular conduction abnormality greater than first-degree block
Primary liver disease resulted in cirrhosis or abnormal liver function tests (transaminases and alkaline phosphatase levels 3 times the upper limit of normal
Acute malignancy
Active infection requiring antimicrobial treatment (Suppression antimicrobial for chronic infections are exempt)
Intervention: Lycopene
Trial phase: Phase 4
SMILES: CC(C)=CCCC(C)=CC=CC(C)=CC=CC(C)=CC=CC=C(C)C=CC=C(C)C=CC=C(C)CCC=C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Lycopene- 4 mg capsule by mouth single dose per day for 2 months
Eligibility criteria:
Inclusion Criteria:

Subject had symptomatic i.e. burning sensation and/or pain secondary to oral lichen planus.
Subject had clinically & histo-pathologically diagnosed as oral lichen planus.
Subject had not on any treatment for the same or treatment likely to modify their oral lichen planus (e.g. systemic steroids, antifungals, immunosuppressant's, anti-oxidant).

Exclusion Criteria:

Suffering from any systemic disease/s such as diabetes, hypertension, cardiovascular, respiratory system disease, renal dysfunction, liver disorders, malignancy, active peptic ulcer diseases, acute gastrointestinal diseases, anemia and glaucoma, etc.
Suffering from serious or recurrent infection, immunodeficiency or HIV.
Pregnant or breast feeding (including women who wish to be pregnant during the study period).
Any other mucosal diseases or any other skin diseases which might be associated with oral lesions.
On any drug therapy which might be causes lichen planus like lesions.
Known allergy or contraindication to study medications.
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: No
Participants at risk: 30
Group description: Subjects who received Metformin in either the first or last 12 weeks of the study
Eligibility criteria:
Inclusion Criteria:

age 18-65 years
a diagnosis of migraine with or without aura for >1 year according to the International Classification of Headache Disorders-IIIb

Exclusion Criteria:

a diagnosis of diabetes mellitus or polycystic ovarian syndrome
overuse of acute migraine treatments
failure to respond to 3 or more classes of preventive drug treatments
change in dose of migraine-preventive medication within 2 months of beginning the baseline diary phase
significant somatic or psychiatric disease
known alcohol or other substance abuse
pregnant or breastfeeding.
Intervention: Tadalafil
Trial phase: Phase 4
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: Male
Age groups: Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Tadalafil capsules

Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.
Eligibility criteria:
Inclusion Criteria:

Men
Age: 30-50 years
BMI: 30 to 39.9 kg/m²
No Pharmacotherapy during the last 3 months
Signature Consent under Information

Exclusion Criteria:

Cholesterol: ≥ 240 mg / dl
Triglycerides: ≥ 400 mg / dl
Fasting glucose: ≥ 126 mg / dl
Diabetes mellitus.
Hypertension
Patients with renal, liver and / or thyroid disease
Consumption of drugs with known effects on glucose or insulin metabolism.
Use of cigar and / or drugs
Hypersensitivity to tadalafil
Intervention: Ibandronate
Trial phase: Phase 4
ATC code: M05BA06 | M05BB09
SMILES: CCCCCN(C)CCC(O)(P(=O)(O)O)P(=O)(O)O
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 308
Group description: Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months. Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group.
Eligibility criteria:
Inclusion Criteria:

Women newly diagnosed with postmenopausal osteoporosis
Naive to prior bisphosphonate therapy

Exclusion Criteria:

Inability to stand or sit upright for at least 60 minutes
Inability to swallow a tablet whole
Hypersensitivity to any component of ibandronate
Hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months
Other osteoporosis drug within last 3 months
Malignant disease diagnosed within previous 10 years, except resected basal cell cancer
Intervention: Iclaprim
Trial phase: Phase 3
ATC code: J01EA03
SMILES: COc1cc(Cc2cnc(N)nc2N)c2c(c1OC)OC(C1CC1)C=C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 298
Group description: iclaprim 80 mg intravenous every 12 hours

iclaprim: Experimental treatment
Eligibility criteria:
Inclusion Criteria:

written informed consent;
≥18 years of age;
a bacterial infection of the skin with a lesion size area of at least 75 cm2;
a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;
the presence of purulent or seropurulent drainage or at least three signs and symptoms of infection (discharge, erythema, swelling, warmth, or pain).

Exclusion Criteria:

severely impaired arterial blood supply such that amputation of the infected anatomical site is likely;
infected diabetic foot ulcers;
infected decubitus ulcers;
necrotizing fasciitis or gangrene;
uncomplicated skin or skin structure infection;
infections associated with a prosthetic device;
suspected or confirmed osteomyelitis;
conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression therapy.
Intervention: Iclaprim
Trial phase: Phase 3
ATC code: J01EA03
SMILES: COc1cc(Cc2cnc(N)nc2N)c2c(c1OC)OC(C1CC1)C=C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 299
Group description: iclaprim 80 mg intravenous every 12 hours

Iclaprim: Experimental treatment
Eligibility criteria:
Inclusion Criteria:

written informed consent;
≥18 years of age;
a bacterial infection of the skin with a lesion size area of at least 75 cm2;
a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;
the presence of purulent or seropurulent drainage or at least three signs and symptoms of infection (discharge, erythema, swelling, warmth, or pain).

Exclusion Criteria:

severely impaired arterial blood supply such that amputation of the infected anatomical site is likely;
infected diabetic foot ulcers;
infected decubitus ulcers;
necrotizing fasciitis or gangrene;
uncomplicated skin or skin structure infection;
infections associated with a prosthetic device;
suspected or confirmed osteomyelitis;
conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression therapy.
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: Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: 1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone

IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone

0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone
Eligibility criteria:
Inclusion Criteria:

Acute (less than 1 week in duration) severe pain necessitating use of intravenous (IV) opioids in the judgement of the treating attending physician

Exclusion Criteria:

Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics.
Prior adverse reaction to hydromorphone, morphine, or acetaminophen.
Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
Systolic Blood Pressure (SBP) <100 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
Heart Rate (HR) < 60/min: Opioids can cause bradycardia.
Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
Patients using transdermal pain patches
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: 14
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
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
Intervention: Olesoxime
Trial phase: Phase 2
SMILES: CC(C)CCCC(C)C1CCC2C3CCC4=CC(=NO)CCC4(C)C3CCC12C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 131
Group description: Participants received a dose of 10 mg/kg suspension once a day (QD) orally or via a naso-gastric or gastronomy tube. Participants who consented to dose increase received 10 milligrams per kilogram (mg/kg) suspension twice a day (BID) either orally or via a naso-gastric or gastrostomy tube.
Eligibility criteria:
Inclusion Criteria:

Participation in the previous studies (TRO19622 CL E Q 1115-1 or TRO19622 CL E Q 1275-1)
For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 28 days after the last dose of olesoxime

Exclusion Criteria:

Female participants who are pregnant or lactating, or intending to become pregnant during the study
Participants who, in the opinion of the investigator, are not suitable to participate in this open-label study
Participants who have developed study drug hypersensitivity to olesoxime or one of the formulation excipients, including sesame oil
Concomitant or previous participation in any investigational drug or device study within 90 days prior to screening
Concomitant or previous participation in a survival motor neuron 2 (SMN2) targeting antisense oligonucleotide study within 6 months prior to screening
History of human immunodeficiency virus infection, history of Hepatitis B infection within the past year, history of Hepatitis C infection which has not been adequately treated
History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study
History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion