anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Levosimendan
Trial phase: Phase 2
ATC code: C01CX08
SMILES: C[C@@H]1CC(=O)NN=C1c1ccc(NN=C(C#N)C#N)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
Eligibility criteria:
Inclusion Criteria:

All patients will have either a sinus or paced atrial rhythm with atrioventricular synchrony on electrocardiography
All patients will have a history of heart failure diagnosed clinically with history of prior symptoms or signs of heart failure with at least one of the following symptoms within the past month: dyspnea on exertion, orthopnea, paroxysmal nocturnal dyspnea, pedal edema
In asymptomatic patients, patients may be enrolled if they have at least one of the following clinical signs of heart failure: left ventricular third and/or fourth heart sound, jugular venous pressure >7 mmHg, sustained left ventricular impulse, or pulmonary congestion on auscultation
all patients will have echocardiographic evidence of left ventricular dysfunction

Exclusion Criteria:

Under age 18
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: 5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
Eligibility criteria:
Inclusion Criteria:

all burn service patients with a wound vac

Exclusion Criteria:

allergy to lidocaine
Intervention: Clenbuterol
Trial phase: Phase 1
ATC code: R03AC14 | R03CC13 | R03CC63
SMILES: CC(C)(C)NCC(O)c1cc(Cl)c(N)c(Cl)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: clenbuterol: Clenbuterol 20 mcg tablets uptitrated from 20 mcg PO TID to a maximally tolerated dose not to exceed 700 mcg PO TID. Patients will then be switched to the equivalent dose of clenbuterol liquid 59 mcg/ml PO TID. Clenbuterol will be administered for a minimum of 3 months and a maximum of 12 months.
Eligibility criteria:
Inclusion Criteria:

Patients with refractory symptomatic heart failure (NYHA Class IV, or Stage D) due to dilated, non-ischemic cardiomyopathy who meet the following criteria:

Severe clinical heart failure with associated haemodynamic compromise resistant to intensive medical therapy and requiring LVAD implantation
Duration of heart failure symptoms to be ≥ 12 months prior to LVAD implant
Documentation of LVEF ≤ 40% at least 1 year prior to LVAD implantation
LVEF ≤ 30% and cardiomegaly at the time of LVAD implantation as documented by radionuclide or contrast ventriculography or by echocardiography
Nonischemic etiology confirmed by coronary angiography within two years of enrollment
Listed for heart transplantation or plan to list for heart transplantation pending successful LVAD implantation in one of the participating centers, as per usual transplant listing policy at each participating center
>= 18 years of age
Body surface area >= 1.5 m2
Have an implantable defibrillator in place or a commitment to implant an ICD prior to hospital discharge
Have undergone insertion within prior 2 weeks or will be inserted with a Heartmate XVE LVAD with use of antimicrobial prophylaxis and drive line restraining belt

Exclusion Criteria:

Not a heart transplant candidate
Evidence of active acute myocarditis
Pulmonary Vascular Resistance > 6 Wood Units
History of previous CVA resulting in significant fixed motor deficit limiting ability to perform exercise testing
Previous prosthetic replacement of aortic and/or mitral valve(s)
Hypertrophic obstructive cardiomyopathy
LVIDD < 5 cm by surface echocardiogram (restrictive cardiomyopathy)
Irreversible multi-organ failure
Underlying bleeding disorder, or platelet count < 75,000, INR > 2.5 (without Coumadin), or Hgb < 8.0.
Pregnant or lactating women or unwilling to utilize two reliable methods of birth control for women of childbearing age
Receipt of other investigational drug therapy during LVAD support
Intervention: Betahistine dihydrochloride
Trial phase: Phase 2
SMILES: CNCCc1ccccn1.Cl.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: All patients start taking betahistine dihydrochloride 50 mg, which will be increased by 50 mg up to a maximum of 300 mg.
Eligibility criteria:
Inclusion Criteria:

Have signed written informed consent
Be male and/or female outpatients 18 65 years of age, inclusive
For women: must be surgically sterile, 2 years postmenopausal, or, if they have childbearing potential, using a medically accepted method of birth control and agree to continue use of this method for at least 30 days after the last dose of study drug (i.e., barrier method with spermicide, steroidal contraceptive or intrauterine device [IUD])
Meet DSM IV1 criteria for major depressive episode (unipolar), with atypical features
Have a score of 20 or greater on the Hamilton Depression Rating, 28-item version (HAM-D-28)
Have a complete medical and psychiatric history, physical examination, laboratory evaluation, and ECG before study entry.
Have baseline laboratory values and ECG that are normal, or abnormalities that are clinically insignificant

Exclusion Criteria:

Have significant and/or unstable gastrointestinal, neurological, endocrine, cardiovascular, pulmonary, renal, hepatic, immunological or hematological disease; organic brain disease; or cancer as determined by history, physical, ECG, and laboratory examination
Have a history of peptic ulcer disease
Have a history of severe asthma
Have a current diagnosis of pheochromocytoma
Are pregnant, intending to become pregnant, nursing, at risk for pregnancy, or not practicing medically acceptable birth control. (A blood pregnancy test will be performed at the screening visit)
Meet criteria for DSM IV1 psychoactive substance abuse or dependence in the past month
Have a history of a psychotic disorder
Use any medications that, in the judgment of the investigator, might have psychotropic effects, or interact unfavorably with betahistine dihydrochloride including centrally acting antihistaminic agents
Have a history of hypersensitivity to betahistine dihydrochloride
Exhibit, or suggestion that they may display, behavior that will not be conducive to the study procedures
Are at significant risk of suicide as indicated by a score of 3 or greater on item number 11 on the HAM-D 28
Have received any investigational product within 28 days of Screening
Have used any antidepressant within 7 days of Screening (14 days for MAOIs; 21 days for fluoxetine)
Intervention: Atorvastatin
Trial phase: Not Applicable
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Heart failure patients assigned to atorvastatin

Atorvastatin: Atorvastatin - 40 mg orally daily for 6 months
Eligibility criteria:
Inclusion Criteria:

Signed informed consent,
Age > 18,
Ejection fraction ≥ 50%,
hospitalization for heart failure in the last 6 months and
current NYHA Class II-IV symptoms, OR

current NYHA Class III-IV symptoms and one of the following:

ECG or echocardiographic evidence of moderate/severe left ventricular hypertrophy,
chest x-ray evidence of pulmonary congestion

Exclusion Criteria:

Probable alternative cause of symptoms (pulmonary disease, severe anemia, etc.)
Prior documented LVEF < 40% or qualitative moderate or greater LV systolic dysfunction.
Current indication for statin therapy
Intolerance to statin therapy.
Documented ischemic heart disease requiring lipid-lowering therapy (i.e. CAD, myocardial infarction, stroke)
Evidence of significant myocardial ischemia on stress testing at screening visit.
Evidence of hepatic abnormality (defined as liver enzymes > 2 times the upper limit of normal values).
Uncontrolled hypertension (BP > 150/100)
Significant valvular disease.
Atrial fibrillation
Known familial hypertrophic cardiomyopathy or obstructive hypertrophic cardiomyopathy.
Restrictive cardiomyopathy or systemic illness known to be associated with infiltrative heart disease (i.e. amyloidosis, sarcoidosis, hemochromatosis).
Cor pulmonale or other cause of right heart failure not related to LV dysfunction.
Clinically significant pulmonary disease.
Pericardial constriction or hemodynamically significant pleural effusion.
Uncontrolled arrhythmia.
Any systemic condition other than heart failure that may limit survival to less than 2 years.
Advance renal disease (serum creatinine > 3.0 mg/dl or on dialysis)
Known intolerance or allergy to HMG CoA reductase inhibitors
Uncontrolled hyper- or hypothyroidism.
Any subject characteristic that may interfere with study compliance, such as baseline dementia, substance abuse, history of non-compliance with medications or appointments.
Prisoners or other vulnerable populations.
Any woman of child-bearing age with a documented positive pregnancy test.
Subject is receiving therapy with other investigational therapy or is participating in any other clinical trial.
Intervention: Calcitriol
Trial phase: Phase 1
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: 1000 IU of Vitamin D

Vitamin D: Taken orally every day for three months
Eligibility criteria:
Inclusion Criteria:

Between the ages of 30 and 80 years
Comfortable communicating in English
Currently has a primary care physician
Willing to discontinue vitamin D or calcium supplements
Willing to have all protocol specific tests run

Exclusion Criteria:

Plans on taking a vacation or travel to a sunny region within 3 months of vitamin supplementation period except for a short period (i.e. 1 weekend)
Pregnant or breast feeding or planning on becoming pregnant in the following year
Pre-existing calcium (including hypercalcemia), parathyroid conditions (including hyperparathyroidism), sarcoidosis
No concurrent active malignancies (other than non-melanoma skin cancer) or previous diagnosis of prostate cancer
Cognitively impaired
Active thyroid disease (e.g. Graves, Hashimoto's or thyroiditis)
History of nephrolithiasis, chronic liver disease, chronic renal disease, or renal dialysis
Intervention: Calcitriol
Trial phase: Phase 1
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: 2000 IU of Vitamin D

Vitamin D: Taken orally every day for three months
Eligibility criteria:
Inclusion Criteria:

Between the ages of 30 and 80 years
Comfortable communicating in English
Currently has a primary care physician
Willing to discontinue vitamin D or calcium supplements
Willing to have all protocol specific tests run

Exclusion Criteria:

Plans on taking a vacation or travel to a sunny region within 3 months of vitamin supplementation period except for a short period (i.e. 1 weekend)
Pregnant or breast feeding or planning on becoming pregnant in the following year
Pre-existing calcium (including hypercalcemia), parathyroid conditions (including hyperparathyroidism), sarcoidosis
No concurrent active malignancies (other than non-melanoma skin cancer) or previous diagnosis of prostate cancer
Cognitively impaired
Active thyroid disease (e.g. Graves, Hashimoto's or thyroiditis)
History of nephrolithiasis, chronic liver disease, chronic renal disease, or renal dialysis
Intervention: Calcitriol
Trial phase: Phase 1
ATC code: A11CC04 | D05AX03
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)(C)O)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)C[C@H](O)C1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 18
Group description: 4000 IU of Vitamin D

Vitamin D: Taken orally every day for three months
Eligibility criteria:
Inclusion Criteria:

Between the ages of 30 and 80 years
Comfortable communicating in English
Currently has a primary care physician
Willing to discontinue vitamin D or calcium supplements
Willing to have all protocol specific tests run

Exclusion Criteria:

Plans on taking a vacation or travel to a sunny region within 3 months of vitamin supplementation period except for a short period (i.e. 1 weekend)
Pregnant or breast feeding or planning on becoming pregnant in the following year
Pre-existing calcium (including hypercalcemia), parathyroid conditions (including hyperparathyroidism), sarcoidosis
No concurrent active malignancies (other than non-melanoma skin cancer) or previous diagnosis of prostate cancer
Cognitively impaired
Active thyroid disease (e.g. Graves, Hashimoto's or thyroiditis)
History of nephrolithiasis, chronic liver disease, chronic renal disease, or renal dialysis
Intervention: Prazosin
Trial phase: Phase 1 | Phase 2
ATC code: C02CA01 | C02LE01
SMILES: COc1cc2nc(N3CCN(C(=O)c4ccco4)CC3)nc(N)c2cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: High AW scoring at or above 3 on Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) assessment randomized to Prazosin 16 mg/day (tid) administered for 12 weeks.

Prazosin Tablet: Target medication dosing was three times/day (t.i.d. dosing) with 5 mg in the morning, 5 mg in the afternoon and 6 mg at night reached at the end of the 2-week period, and maintained at this or their highest tolerated dose until week 11, followed by a 5-day taper in week 12, as in previous research.
Eligibility criteria:
Inclusion Criteria:

Male or female individuals, ages 18-70 with alcohol dependence, treatment seeking with varying levels of alcohol withdrawal symptoms.
meet current DSM-IV criteria for alcohol dependence,
Subject has voluntarily given informed consent and signed the informed consent document.
Able to read English and complete study evaluations.

Exclusion Criteria:

Meet current criteria for dependence on another psychoactive substance, excluding nicotine and caffeine;
Any current use of opiates;
Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or disulfram, except for stabilized on SSRIs
Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders
Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study;
Hypotensive individuals with sitting blood pressure below 90/60 mmHG.
Intervention: Prazosin
Trial phase: Phase 1 | Phase 2
ATC code: C02CA01 | C02LE01
SMILES: COc1cc2nc(N3CCN(C(=O)c4ccco4)CC3)nc(N)c2cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Low AW scoring at or below 2 on Clinical Institute of Withdrawal for Alcohol Revised (CIWA-Ar) assessment randomized to Prazosin 16 mg/day (tid) administered for 12 weeks in a double blind manner.

Prazosin Tablet: Target medication dosing was three times/day (t.i.d. dosing) with 5 mg in the morning, 5 mg in the afternoon and 6 mg at night reached at the end of the 2-week period, and maintained at this or their highest tolerated dose until week 11, followed by a 5-day taper in week 12, as in previous research.
Eligibility criteria:
Inclusion Criteria:

Male or female individuals, ages 18-70 with alcohol dependence, treatment seeking with varying levels of alcohol withdrawal symptoms.
meet current DSM-IV criteria for alcohol dependence,
Subject has voluntarily given informed consent and signed the informed consent document.
Able to read English and complete study evaluations.

Exclusion Criteria:

Meet current criteria for dependence on another psychoactive substance, excluding nicotine and caffeine;
Any current use of opiates;
Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or disulfram, except for stabilized on SSRIs
Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders
Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study;
Hypotensive individuals with sitting blood pressure below 90/60 mmHG.
Intervention: GLUTAMINE
Trial phase: Phase 2
ATC code: A16AA03
SMILES: NC(=O)CCC(N)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: L-glutamine group will be given at the following dosage:

17-33.3 kg at 5 g 2x daily 33.4-66.6 kg at 10 g 2X daily >66.7 at 15 g 2X daily

L-Glutamine: L-Glutamine at: 5 g 2X daily (17-33.3 Kg) 10 g 2x daily (33.4-66.6 Kg) 15 g 2x daily (>66.7 kg)
Eligibility criteria:
Inclusion Criteria:

To be eligible to participate in the study, a patient must meet all of the following inclusion criteria:

Patient is at least 18 years of age.
Patient has been diagnosed with sickle cell anemia or sickle ß0-thalassemia (documented by hemoglobin electrophoresis).
Patient has had at least two episodes of painful crises within 12 months of the screening visit.
If the patient has been treated with an anti-sickling agent within three months of the screening visit, the therapy must have been continuous for at least three months with the intent to continue for the next 14 months.
Patient or the patient's legally authorized representative has given written informed consent.
If the patient is a female of child-bearing potential, she agrees to practice a recognized form of birth control during the course of the study.
Patient is able to perform exercise tolerance test

Exclusion Criteria:

If the patient meets any of the following criteria, the patient must not be enrolled:

Patient has a significant medical condition that required hospitalization (other than sickle painful crisis) within two months of the screening visit.
Patient has diabetes mellitus with untreated fasting blood sugar >115 mg/dL.
Patient has prothrombin time International Normalized Ratio (INR) > 2.0.
Patient has serum albumin < 3.0 g/dl.
Patient has received any blood products within three weeks of the screening visit.
Patient has a history of uncontrolled liver disease or renal insufficiency.
Patient is pregnant or lactating.
Patient has been treated with an experimental anti-sickling medication/treatment (except hydroxyurea) within 30 days of the screening visit.
Patient has been treated with an experimental drug within 30 days of the screening visit.
There are factors that would, in the judgment of the investigator, make it difficult for the patient to comply with the requirements of the study.
Intervention: Nicotine
Trial phase: Phase 4
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.

Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times.
Eligibility criteria:
Inclusion Criteria:

Current cigarette smoker, defined as >100 cigarettes lifetime consumption and self report of smoking every day
Scheduled for elective non-cardiac surgery

Exclusion Criteria:

An inability to understand consent procedures
History of an allergic reaction to nicotine replacement therapy
History of sustained ventricular tachycardia
Untreated hyperthyroidism or pheochromocytoma
Currently utilizing pharmacologic agents specifically to treat nicotine dependence, including nicotine replacement therapy and bupropion (for a stop-smoking indication)
Active (within the past 12 months) non-nicotine drug dependence
Females who are pregnant or lactating
Patients with phenylketonuria, because the lozenges contain aspartame, which is metabolized to phenylalanine.
Lack of access to a telephone, as one follow-up will be performed using this means.
Intervention: Bepotastine besilate
Trial phase: Phase 3
SMILES: O=C(O)CCCN1CCC(OC(c2ccc(Cl)cc2)c2ccccn2)CC1.O=S(=O)(O)c1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 575
Group description: One drop, both eyes, twice a day for six weeks
Eligibility criteria:
Inclusion Criteria:

Subjects must be at least 3 years of age, and have ocular health within normal limits

Exclusion Criteria:

No active ocular disease
Intervention: Bepotastine besilate
Trial phase: Phase 3
SMILES: O=C(O)CCCN1CCC(OC(c2ccc(Cl)cc2)c2ccccn2)CC1.O=S(=O)(O)c1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
Eligibility criteria:
Inclusion Criteria:

Subjects must be at least 10 years of age

Exclusion Criteria:

No active ocular disease
Intervention: Bepotastine besilate
Trial phase: Phase 3
SMILES: O=C(O)CCCN1CCC(OC(c2ccc(Cl)cc2)c2ccccn2)CC1.O=S(=O)(O)c1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: 1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
Eligibility criteria:
Inclusion Criteria:

Subjects must be at least 10 years of age

Exclusion Criteria:

No active ocular disease
Intervention: Mafenide Acetate
Trial phase: Not Applicable
SMILES: CC(=O)O.NCc1ccc(S(N)(=O)=O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: 5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
Eligibility criteria:
Inclusion Criteria:

Male or female, aged 18 years and over requiring hospitalization for burn injury
Burn injury requiring wound excision and auto-grafting
Less than or equal to 20% Total Body Surface Area burns

Exclusion Criteria:

Pregnant or lactating females
Individuals with chlorine sensitivity
Electrical, chemical and cold injury
Burns to the face, hands, feet and or perineum area
Steroid therapy