anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Pimecrolimus
Trial phase: Not Applicable
ATC code: D11AH02
SMILES: CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(Cl)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.

Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit).
Eligibility criteria:
Inclusion Criteria:

Age 18-70 years
Target lesion IGA ≥2
Target IGA=0 (for non-lesional site)
Male or female of any race and ethnicity
Chronic AD for more than one year duration
Subject of child-bearing potential must be willing to practice effective birth control during the study
Subject agrees to comply with study requirements and attend all required visits.

Exclusion Criteria:

Patients ≥ 18 years of age with only AD of the face
Women of childbearing potential not using the contraception method(s) specified in this study (abstinence, IUD, diaphragm, oral contraceptives)
Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
Hypersensitivity to pimecrolimus cream or any excipient of the cream
Subject has a skin disorder in addition to dermatitis in the areas to be treated
Subject has Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier
Pregnant or nursing females
Immunocompromised patient (e.g., lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome), or with a history of active or malignant disease (excluding non-melanoma skin cancer)
History of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol
Patients known to be non-compliant with a medication regimen
Subjects with significant concurrent medical condition(s) at screening that in the view of the investigator prohibits participation in the study (e.g., severe concurrent allergic disease, condition associated with malignancy, and condition associated with immunosuppression)
Active viral or fungal skin infections at the target areas
Previous participation in this study
Ongoing participation in another investigational trial
Use of any oral or topical antibiotic during the study and up to one week prior to entering the study
Use of any local therapy for AD less than one week prior to screening
Use of any systemic immunosuppressive therapy for AD less than four weeks prior to screening.
Intervention: Sitagliptin
Trial phase: Phase 2
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Januvia: 1 tablet 100 mg once a day
Eligibility criteria:
Inclusion Criteria:

Hct level of at least 34% for women and 36% for men
Women of non-bearing potential and women of childbearing potential using adequate contraception
Serum creatine level of less than 1.7 mg/dl

Four groups:

Age 21-45 (BMI between 18.50-24.99) & (BMI between 30-35)
Age greater than 65 years (BMI between 18.50-24.99) & (BMI between 30-35)

Exclusion Criteria:

Pregnant and/or lactating females
Women of childbearing potential not willing to use adequate contraception
Hct below inclusion criteria
Serum creatine level greater than 1.8 mg/dl
Age less than 21 and age between 46-64
Diabetes mellitus
BMI less than 18 and BMI greater than 35
Intervention: Aripiprazole
Trial phase: Not Applicable
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
Eligibility criteria:
Inclusion Criteria:

Eligible patients:

Must be outpatients between the ages of 18 and 65 at the start of study
May be male or female
Have DSM-IV trichotillomania of at least 6 months duration

Allowed psychotropic medications are limited to:

SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline), SNRIs (duloxetine, venlafaxine) and mirtazapine, as long as the dosage has not changed for 4 weeks prior to study enrollment.
Other allowed medications include non-hypnotic sleeping agents, specifically trazodone, diphenhydramine, hydoxyzine and ramelteon.
If a patient is taking non-allowed psychotropic medications, he/she must be titrated off by the prescribing physician and be off of the medication for at least 2 weeks prior to trial enrollment.

We will not exclude patients meeting DSM-IV criteria for:

body dysmorphic disorder;
major depression;
dysthymia;
GAD, social phobia, panic disorder.

Exclusion Criteria:

We will exclude patients suffering from:

organic mental disorders;
psychotic mental disorders including delusional disorder, somatic type;
mental retardation or developmental disabilities;
substance or alcohol abuse;
depressive disorders with current suicidal risk;
factitious disorders;
dissociative disorders;
obsessive compulsive disorder;
personality disorders sufficiently severe to interfere with cooperation with the study;
bipolar I or II disorder.
Patients taking psychotropic agents other than those specifically listed in item d above. If a patient is taking non-allowed psychotropic medications, he/she must be titrated off such medications by the prescribing physician and be off of the medication for 2 weeks prior to trial enrollment.
Pregnant or nursing women.
Patients with a known hypersensitivity or allergy to aripiprazole.
Intervention: Ataluren
Trial phase: Phase 2
ATC code: M09AX03
SMILES: O=C(O)c1cccc(-c2noc(-c3ccccc3F)n2)c1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Ataluren was provided as a vanilla-flavored powder to be mixed with water or milk. Ataluren was taken 3 times per day, with dosing based on the participant's body weight. The dose level for ataluren was 5 mg/kg in the morning, 5 mg/kg at midday, and 10 mg/kg in the evening or 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for 14 days, followed by an interval of 14 days without treatment.
Eligibility criteria:
Inclusion Criteria:

Ability to provide written informed consent
Age ≥18 years
Presence of a nonsense mutation as the sole disease-causing mutation in the FVIII or FIX gene
At least 20 prior treatments with FVIII or FIX concentrates
Willingness and ability to comply with scheduled visits, drug administration plan, study restrictions, and study procedures

Exclusion Criteria:

Known hypersensitivity to any of the ingredients or excipients of the study drug
Any history of prior anti-FVIII/FIX inhibitors
Unable or unwilling to forego prophylactic FVIII/FIX concentrate use during the screening and on-study periods (Note: Participants were allowed use of FVIII/FIX concentrates for treatment of bleeding episodes while on study)
Intervention: GLYCEROL PHENYLBUTYRATE
Trial phase: Phase 3
ATC code: A16AX09
SMILES: O=C(CCCc1ccccc1)OCC(COC(=O)CCCc1ccccc1)OC(=O)CCCc1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Patients who were treated with HPN-100
Eligibility criteria:
Inclusion Criteria:

Male and female subjects who completed HPN-100-006:

*Additionally, approximately 20 UCD subjects ≥ 6 years of age may be enrolled who have not participated in HPN-100-006. These subjects may include those who did not qualify HPN-100-006 (e.g., subjects between the ages of 6-17 years, subjects with other UCD subtypes, or adult subjects who have not taken sodium phenylbutyrate (NaPBA) in the past 6 months, etc.). For adult subjects not receiving NaPBA in the past 6 months, subjects must, in the judgment of the investigator, be anticipated to benefit from the addition of a nitrogen-scavenging agent to their current treatment. Clinical evidence of potential benefit from introduction of an ammonia-scavenging agent might include a recent history (in the past year) of clinically overt hyperammonemia accompanied by a venous ammonia ≥ 100 μmol/L, a recent history (within the past year) of protein intolerance, or a history of abnormally high venous ammonia levels accompanied by symptoms (e.g., headache) that might reasonably be attributed to hyperammonemia.

Signed informed consent by subject and/or subject's legally acceptable representative.
Diagnosis of urea cycle disorder (enzyme or transporter deficiency) confirmed via enzymatic, biochemical, or genetic testing.
Able to perform and comply with study activities, including blood draws.
Negative pregnancy test for all females of childbearing potential.
All females of childbearing potential and all sexually active males must agree to use an acceptable method of contraception throughout the study.

Exclusion Criteria:

Screening venous ammonia level of ≥ 100 μmol/L or signs and symptoms indicative of hyperammonemia; subjects may be re-screened after their venous ammonia is controlled, at the discretion of the investigator.
History of 4 or more hyperammonemic events as defined in Section 3.5.1 in the preceding 12 months.
Active infection (viral or bacterial) or any other condition that may increase venous ammonia levels.
Any clinical or laboratory abnormality or medical condition that, at the discretion of the investigator, may put the subject at increased risk by participating in this study.
Use of any medication known to significantly affect renal clearance (e.g., probenecid) or to increase protein catabolism (e.g., corticosteroids), or other medication known to increase venous ammonia levels (e.g., valproate), within the 24 hours prior to Day 1 and throughout the study.
History of QTc (QT interval corrected) prolongation, or a QTc interval ≥ 450 msec or an increase of ≥ 60 msec during the previous HPN-100 study if applicable.
Known hypersensitivity to PAA or PBA.
Liver transplant, including hepatocellular transplant.
Breastfeeding or lactating females.
Intervention: METHYLPREDNISOLONE ACETATE
Trial phase: Phase 2 | Phase 3
SMILES: CC(=O)OCC(=O)[C@@]1(O)CC[C@H]2[C@@H]3C[C@H](C)C4=CC(=O)C=C[C@]4(C)[C@H]3[C@@H](O)C[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
Eligibility criteria:
Inclusion Criteria:

Cases of lateral epicondylitis.
Men and women above fifteen years of age.

Exclusion Criteria:

Patients receiving steroid injections within three months before blood injection.
A history of substantial trauma.
Previously treated by surgery for lateral epicondylitis.
Other causes of elbow pain such as osteochondritis dessecans of capitellum, lateral compartment arthrosis, varus instability, radial head arthritis, posterior interosseous nerve syndrome, cervical disc syndrome, synovitis of radiohumeral joint, cervical radiculopathy, fibromyalgia, osteoarthritis of elbow, carpel tunnel syndrome.
Intervention: Varenicline
Trial phase: Phase 4
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 48
Group description: Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.
Eligibility criteria:
Inclusion Criteria:

self report minimum 10 daily cigarettes
self report smoking every day past 5 years
between the ages 21-65
self report intention to try to quit smoking in the next 6 months

Exclusion Criteria:

self reported use of any nicotine-containing products other than non-menthol cigarettes
self reported history or current treatment of substance abuse (other than nicotine dependence)
self reported alcohol use greater than 25 standard drinks per week;
currently pregnant, planned pregnancy or lactating (females: negative urine pregnancy screen)
self reported history or current diagnosis of any Axis 1 disorders except past depression
self reported serious or unstable disease within past year
self reported history of epilepsy or seizure disorder;
self reported history or current diagnosis of COPD (chronic obstructive pulmonary disease), cardiovascular disease, heart attack, or uncontrolled hypertension
self reported kidney function impairment
any current or recent (30 day) use of: smoking cessation medications, anti-psychotics, anti-depressants, anti-anxiety, panic medications, stimulants or opiate-containing medications
less than 5 years of daily smoking
any medical condition or concomitant medication that could compromise participant safety or treatment
provide a baseline carbon monoxide (CO) reading < 10 ppm
self reported use of non filtered cigarettes
inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician
Intervention: Varenicline
Trial phase: Phase 4
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 48
Group description: Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.

Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.
Eligibility criteria:
Inclusion Criteria:

self report minimum 10 daily cigarettes
self report smoking every day past 5 years
between the ages 21-65
self report intention to try to quit smoking in the next 6 months

Exclusion Criteria:

self reported use of any nicotine-containing products other than non-menthol cigarettes
self reported history or current treatment of substance abuse (other than nicotine dependence)
self reported alcohol use greater than 25 standard drinks per week;
currently pregnant, planned pregnancy or lactating (females: negative urine pregnancy screen)
self reported history or current diagnosis of any Axis 1 disorders except past depression
self reported serious or unstable disease within past year
self reported history of epilepsy or seizure disorder;
self reported history or current diagnosis of COPD (chronic obstructive pulmonary disease), cardiovascular disease, heart attack, or uncontrolled hypertension
self reported kidney function impairment
any current or recent (30 day) use of: smoking cessation medications, anti-psychotics, anti-depressants, anti-anxiety, panic medications, stimulants or opiate-containing medications
less than 5 years of daily smoking
any medical condition or concomitant medication that could compromise participant safety or treatment
provide a baseline carbon monoxide (CO) reading < 10 ppm
self reported use of non filtered cigarettes
inability to provide informed consent or complete any of the study tasks as determined by the Principal Investigator and/or Study Physician
Intervention: Nitric Oxide
Trial phase: Not Applicable
ATC code: R07AX01
SMILES: [N]=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Will receive Nitric oxide and other standard inhaled anesthetics

Nitric Oxide: Inhalation - 40 ppm, at the initiation of anesthesia to the end of surgery
Eligibility criteria:
Inclusion Criteria:

Age 18 - 69 years of age
moderate to severe liver disease (MELD score 22 to 30)
is receiving a extended donor criteria liver graft

Exclusion Criteria:

undergoing multi-organ transplant
70 years or older
diagnosed with hepatocarcinoma
diagnosed with either hepatopulmonary syndrome or pulmonary hypertension
pregnant
Intervention: Calcitriol
Trial phase: Not Applicable
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: No
Participants at risk: 65
Group description: Two 50,000 IU tablets of oral Vitamin D3 will be given every 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Males or females, 18-70 years of age and self-identified as African-American or Black
Hypertension
If a potential study patient is not on treatment, their systolic blood pressure (SBP) must be > 130 mmHg, or diastolic blood pressure (DBP) > 85 mmHg, and SBP must be <160 mmHg and DBP must be < 105 mmHg.
If a potential study patient is on treatment then the SBP must be <160 mmHg and DBP must be < 105 mmHg
Screening Vitamin D (D2 and D3 level) between 10 and 25 ng/ml (normal level > 30 ng/ml)
Body mass index (BMI) > 25 kg/m2

Exclusion Criteria:

Poorly controlled high blood pressure (SBP >160 mmHg or DBP > 105 mmHg)
Diabetes (fasting blood sugar > 125 mg/dl, or HbA1c > 6.5%)
Screening Vitamin D (D2 and D3 level) < 10 ng/ml or > 25 ng/ml
Estimated glomerular filtration rate (eGFR) < 45 ml/min
Evidence of disease resulting in hypercalcemia
History of kidney stones
History of drug, alcohol, or illicit substance abuse within the past 6 months
History of another chronic disease which the investigator feels should preclude the subject from entering the study
Liver function tests (LFTs) greater than twice the upper limit of normal
Subjects requiring chronic use of nonsteroidal anti-inflammatory drugs, aspirin, or other drugs that may affect the measurement of reactive oxidative species
Subjects requiring treatment with other vitamin D preparations containing more than 400 IU of vitamin D
Subjects requiring chronic use of immunosuppressive therapy or corticosteroids
Recent (< 6 months) myocardial infarction, stroke, or hospitalization for congestive heart failure
Allergy/intolerance: known allergy to oral vitamin D or microcrystalline cellulose
Intervention: Maraviroc
Trial phase: Phase 1 | Phase 2
ATC code: J05AX09
SMILES: Cc1nnc(C(C)C)n1[C@@H]1C[C@H]2CC[C@@H](C1)N2CC[C@H](NC(=O)C1CCC(F)(F)CC1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: 150mg twice daily

Maraviroc 150 MG: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
Eligibility criteria:
Inclusion Criteria:

patients scheduled to undergo non-myeloablative allogeneic stem-cell transplantation.

meet institutional eligibility criteria for allogeneic SCT. Significant criteria are:

Renal function: Serum creatinine <2; or calculated creatinine clearance > 40 mL/min/1.72m2;
Hepatic function: Baseline direct bilirubin, ALT or AST lower than three times the upper limit of normal;
Pulmonary disease: FVC or FEV1 > 40% predicted; Cardiac ejection fraction > 40%.

Exclusion Criteria:

Patients not expected to be available for follow-up in our institution for at least 100 days after the transplant
Patients who are not undergoing standard non-myeloablative SCT with Flu/Bu conditioning and Tax/MTX GVHD prophylaxis
Patients with uncontrolled bacterial, viral or fungal infections
Patients who take strong inducers or inhibitors of the CYP450A4
Patients receiving other investigational drugs for GVHD
Women who are pregnant, plan to become pregnant or are breastfeeding
Intervention: Maraviroc
Trial phase: Phase 1 | Phase 2
ATC code: J05AX09
SMILES: Cc1nnc(C(C)C)n1[C@@H]1C[C@H]2CC[C@@H](C1)N2CC[C@H](NC(=O)C1CCC(F)(F)CC1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: 300mg twice daily

Maraviroc 300 mg: Maraviroc b.i.d. (in addition to the standard prophylaxis therapy of tacrolimus and methotrexate) beginning after last dose of chemotherapy conditioning regimen until day 30 after stem-cell infusion.
Eligibility criteria:
Inclusion Criteria:

patients scheduled to undergo non-myeloablative allogeneic stem-cell transplantation.

meet institutional eligibility criteria for allogeneic SCT. Significant criteria are:

Renal function: Serum creatinine <2; or calculated creatinine clearance > 40 mL/min/1.72m2;
Hepatic function: Baseline direct bilirubin, ALT or AST lower than three times the upper limit of normal;
Pulmonary disease: FVC or FEV1 > 40% predicted; Cardiac ejection fraction > 40%.

Exclusion Criteria:

Patients not expected to be available for follow-up in our institution for at least 100 days after the transplant
Patients who are not undergoing standard non-myeloablative SCT with Flu/Bu conditioning and Tax/MTX GVHD prophylaxis
Patients with uncontrolled bacterial, viral or fungal infections
Patients who take strong inducers or inhibitors of the CYP450A4
Patients receiving other investigational drugs for GVHD
Women who are pregnant, plan to become pregnant or are breastfeeding
Intervention: OLMESARTAN MEDOXOMIL
Trial phase: Phase 4
ATC code: C09CA08
SMILES: CCCc1nc(C(C)(C)O)c(C(=O)OCc2oc(=O)oc2C)n1Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 420
Group description: Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
Eligibility criteria:
Inclusion Criteria:

Males or females aged > 18 years who are not institutionalized and have signed informed consent.
Mean cuff seated diastolic blood pressure (BP) must be > 95 mmHg and < 115 mmHg and a mean cuff seated systolic BP must be < 180 mmHg when measured at two consecutive qualification study visits during the placebo run-in phase.
The difference in mean cuff seated diastolic BP must be < 7 mmHg between two consecutive qualification study visits during the placebo run-in phase.

Exclusion Criteria:

Subjects with type 2 diabetes mellitus with an HbA1c ≥ 9.5% at Screening.
Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of olmesartan medoxomil and losartan potassium, including cardiovascular, renal (including the absence of one kidney), pulmonary, hepatic, gastrointestinal (including clinically significant malabsorption), endocrine/metabolic (with the exception of non-insulin, dependent type 2 diabetes mellitus with HbA1c < 9.5% at Screening), hematologic/oncologic (including an active malignancy other than basal cell carcinoma), neurologic and psychiatric diseases.
Subjects with a history of myocardial infarction, angina, coronary angioplasty, bypass surgery or heart failure within the last 12 months.
Subjects with any history of New York Heart Association Class III or IV congestive heart failure (CHF). A history of New York Heart Association Class I or II CHF may be exclusionary at the discretion of the Investigator.
Subjects with a history of cerebrovascular accident or transient ischemic attack within the last 1 year.
Subjects with clinically significant cardiac conduction defects, including second or third degree atrioventricular (AV) block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication.