anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: 6-(2-(Fluoro-18F)-propyl)-4-methyl-2-pyridinamine
Trial phase: Early Phase 1
SMILES: Cc1cc(N)nc(CC(C)F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 26
Group description: To determine its potential for use in humans, we measured 18F-NOS myocardial activity in patients after orthotopic heart transplantation (OHT) (9 women and 9 men) and normal healthy volunteers (2 women and 2 men), and correlated it with pathologic allograft rejection, tissue iNOS levels, and calculated human radiation dosimetry.

[18F](+/-)NOS: Injection of radiotracer [18F](+/-)NOS for PET imaging and kinetic data analysis
Eligibility criteria:
Inclusion Criteria:

The OHT patients will be undergoing surveillance endomyocardial biopsy and will Patients 21 years of age or older of either sex, who are status-post OHT and normal healthy volunteers (2 women and 2 men) will be enrolled.be on standard immunosuppressive therapy and anti-hyperlipidemic, anti-hypertensive and anti-diabetic therapies as needed. "Healthy volunteer" is someone who has volunteered to be imaged and who, based on physical exam and baseline electrocardiogram, has no evidence of cardiovascular disease, is not on medication, such as steroids, that will interfere with the accuracy of measuring [18F](+/-)NOS activity and is not under the care of a physician for any active medical conditions.
Able to give informed consent.
Not currently pregnant or nursing: Female subjects must be either: surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of [18F](+/-)NOS) is negative.

Exclusion Criteria:

Patients with an unstable cardiovascular (e.g., severe rejection) or other clinical condition (e.g., active severe infection) that in the opinion of the Principal Investigator or designee or Dr. Ewald precludes participation in the study.
Unable to tolerate 60-90 mins of PET imaging or is claustrophobic.
Normal volunteers with evidence of cardiovascular disease or other diseases based on clinical evaluation and/or blood laboratory tests, which are judged by the Principal Investigator or designee to interfere with accurate determination of the of [18F](+/-)NOS on such measures.
Intervention: 6-(2-(Fluoro-18F)-propyl)-4-methyl-2-pyridinamine
Trial phase: Early Phase 1
SMILES: Cc1cc(N)nc(CC(C)F)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 26
Group description: Measurement of myocardial levels of enzyme nitric oxide synthase(iNOS) using PET and 18F-NOS in post heart transplant patients (5 women and 5 men) undergoing endomyocardial biopsy as part of their normal post-transplant evaluation. Kinetic data of the tracer will be compared with the heart tissue measurements of iNOS measured by immunohistochemistry.

[18F](+/-)NOS: Injection of radiotracer [18F](+/-)NOS for PET imaging and kinetic data analysis
Eligibility criteria:
Inclusion Criteria:

The OHT patients will be undergoing surveillance endomyocardial biopsy and will Patients 21 years of age or older of either sex, who are status-post OHT and normal healthy volunteers (2 women and 2 men) will be enrolled.be on standard immunosuppressive therapy and anti-hyperlipidemic, anti-hypertensive and anti-diabetic therapies as needed. "Healthy volunteer" is someone who has volunteered to be imaged and who, based on physical exam and baseline electrocardiogram, has no evidence of cardiovascular disease, is not on medication, such as steroids, that will interfere with the accuracy of measuring [18F](+/-)NOS activity and is not under the care of a physician for any active medical conditions.
Able to give informed consent.
Not currently pregnant or nursing: Female subjects must be either: surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of [18F](+/-)NOS) is negative.

Exclusion Criteria:

Patients with an unstable cardiovascular (e.g., severe rejection) or other clinical condition (e.g., active severe infection) that in the opinion of the Principal Investigator or designee or Dr. Ewald precludes participation in the study.
Unable to tolerate 60-90 mins of PET imaging or is claustrophobic.
Normal volunteers with evidence of cardiovascular disease or other diseases based on clinical evaluation and/or blood laboratory tests, which are judged by the Principal Investigator or designee to interfere with accurate determination of the of [18F](+/-)NOS on such measures.
Intervention: Pramipexole
Trial phase: Phase 4
ATC code: N04BC05
SMILES: CCCN[C@@H]1CCc2nc(N)sc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.

Pramipexole: Patients will received increasing dose of pramipexole
Eligibility criteria:
Inclusion Criteria:

Must meet DSM-IV criteria for Major Depressive Disorder
HAM-D score >18 on a 21-item assessment at eligibility
On at least an adequate dose of fluoxetine (40 mg/day), paroxetine (40 mg/day) paroxetine CR (50mg), sertraline (150 mg/day), citalopram (40 mg/day), escitalopram (20 mg/day), venlafaxine (150 mg/day), mirtazapine (30 mg/day), or duloxetine (60 mg/day) for at least 6 weeks (monotherapy).
20-55 years of age

Exclusion Criteria:

Substance abuse in the past 6 months
ECT in the past 6 months
On a MAOI, tricyclic antidepressant, lithium, an antipsychotic, thyroid augmentation, 2 antidepressants simultaneously or lamotrigine
History of any psychosis including psychotic depression
History of Bipolar I, Bipolar II, or Bipolar NOS illness, or concurrent symptoms of mania or hypomania that do not meet the criteria for any bipolar disorder
History of compulsive gambling
Pregnant females or females of childbearing years not using adequate birth control in the opinion of the investigators
Known sensitivity to Pramipexole
Significant suicide risk in the opinion of the investigators
Significant medical conditions that would preclude safe participation in the study in the opinion of the investigators
Psychoactive drugs other than one of the antidepressants listed on Inclusion criteria #4. (A non-barbiturate sedative or hypnotic or benzodiazepine such as trazodone 50mg/day, zolpidem 10mg/day, lorazepam 3mg/day or clonazepam 2mg/day will be allowed if it has been in use for at least 1 month prior to the baseline visit.)
Significant abnormalities are observed in screening laboratory evaluation.
Intervention: Indacaterol
Trial phase: Phase 3
ATC code: R03AC18 | R03AK14 | R03AL04 | R03AL12
SMILES: CCc1cc2c(cc1CC)CC(NC[C@H](O)c1ccc(O)c3[nH]c(=O)ccc13)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 159
Group description: Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

Smoking history of at least 10 pack-years
Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value
Post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion Criteria:

Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization for in the 6 weeks prior to screening
Patients who have had a respiratory tract infection within 6 weeks prior to screening
Patients with concomitant pulmonary disease
Patients with a history of asthma
Patients with diabetes Type I or uncontrolled diabetes Type II
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Maraviroc
Trial phase: Phase 4
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: 1
Group description: Drug: lopinavir/ritonavir plus maraviroc

lopinavir/ritonavir plus maraviroc: Lopinavir/ritonavir 400 mg/100 mg two tablets twice daily with Maraviroc 150 mg one tablet twice daily will be administered for 48 weeks to participants meeting entry criteria.
Eligibility criteria:
Inclusion Criteria:

The patient has signed and dated approved informed consent form.
There is confirmed laboratory diagnosis of HIV infection (positive ELISA HIV antibody test confirmed by Western blot, p24 antigen assay, quantitative HIV-1 RNA assay, or HIV culture).
The patient is at least 18 years of age.
ART-naïve, lopinavir/ritonavir susceptible on genotypic testing, CCR5-tropic virus on Trofile testing (ESTA).
Negative pregnancy test within 72 hours prior to start of study for women of childbearing potential.
Females of childbearing potential and males must utilize effective barrier contraception.
HIV RNA greater than 1,000 copies per mL at entry.
Liver enzymes (AST, ALT) < 3 times the upper limit of normal.

Exclusion Criteria:

Patients who are pregnant or breast-feeding.
Active alcohol or substance abuse sufficient, in the Investigator's opinion that makes compliance to the study protocol unlikely.
Suspected or active HIV-related opportunistic infection or condition requiring acute therapy within 30 days of entry into the trial.
Patients on therapy for hepatitis B.
Patients with hepatitis B surface antigen, or any evidence of active hepatitis B such as positive hepatitis B DNA and/or presence of hepatitis e antigen or e antibody.
Acute hepatitis B or C within 60 days of entry.
Patients harboring preexistent co-receptor CXCR4 tropic or dual-or mixed-tropic HIV.
Patients harboring HIV resistant to lopinavir/ritonavir on genotypic testing.
The presence of decompensated heart failure, myocardial infarction within 1 year, bypass surgery, severe vascular disease, or active hepatobiliary disease.
Concomitant use of rifampin, ergot derivatives (i.e. dihydroergotamine, ergotamine), cisapride, lovastatin, simvastatin, triazolam, orally administered midazolam, carbamazepine, phenytoin, St. John's wort, ketoconazole, itraconazole, clarithromycin, telithromycin, amiodarone, bepridil, flecainide, propafenone, quinidine, voriconazole or nefazodone.
Patients with concomitant diagnosis of malignancy or cancer other than basal cell carcinoma within the past 5 years.
Concomitant use of investigational agents including the use of any investigational vaccines.
Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study, or unable to comply with the dosing requirements.
Intervention: Telapristone acetate
Trial phase: Phase 3
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: Proellex: 2, 25 mg capsules once per day
Eligibility criteria:
Inclusion Criteria:

At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
Subject has a menstrual cycle lasting from 20 to 40 days.
Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Exclusion Criteria:

Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-304.
Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304
Intervention: Telapristone acetate
Trial phase: Phase 3
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: Proellex: 1, 25 mg capsule once per day
Eligibility criteria:
Inclusion Criteria:

At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
Subject has a menstrual cycle lasting from 20 to 40 days.
Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Exclusion Criteria:

Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-304.
Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304
Intervention: Omeprazole
Trial phase: Phase 3
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 214
Group description: Esomeprazole 20mg once daily oral
Eligibility criteria:
Inclusion Criteria:

Provision of written informed consent before starting the study-related procedures and examinations
Patients who have the history of gastric and/or duodenal ulcer.
A diagnosis of a chronic condition (angina pectoris, myocardial infarction and ischemic cerebrovascular disorder, etc., requiring prevention of thrombosis or embolism) which requires taking the prescribed LDA during the study treatment period.

Exclusion Criteria:

Having gastric or duodenal ulcer (except for ulcer scar).
History of esophageal, gastric or duodenal surgery, except for simple closure of perforation.
Intervention: Valsartan
Trial phase: Phase 4
ATC code: C09CA03 | C09DA03 | C09DB01 | C09DB08 | C09DX01 | C09DX02 | C09DX04 | C09DX05 | C10BX10
SMILES: CCCCC(=O)N(Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1)[C@H](C(=O)O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Participants over 18 years of age with hypertension defined as sitting systolic blood pressure between 140 mmHg and 180 mmHg or sitting diastolic blood pressure between 90 mmHg and 120 mmHg.
High risk participants ( defined as having: (diabetes mellitus, chronic renal disease, Framingham 10-year risk score >10%, established coronary artery disease (CAD), or CAD equivalents including carotid artery disease, peripheral arterial disease (PAD), abdominal aortic aneurysm (AAA))with hypertension defined as sitting systolic blood pressure between 130 mmHg and 180 mmHg or sitting diastolic blood pressure between 80 mmHg and 120 mmHg.

Exclusion Criteria:

Known or suspected secondary hypertension
Known New York Heart Association (NYHA) functional class IV Heart Failure
History of myocardial infarction, transient ischemic attack or cerebrovascular accident within the preceding 3 months
Clinically significant valvular disease
Women who are pregnant, intend to become pregnant or are breastfeeding
Participants who have severe medical condition(s) that in the view of the Investigator prohibits participation in the study
Participants who have hypersensitivity to the investigational/ reference drug or any of the components in the formulation.
Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Valsartan
Trial phase: Phase 4
ATC code: C09CA03 | C09DA03 | C09DB01 | C09DB08 | C09DX01 | C09DX02 | C09DX04 | C09DX05 | C10BX10
SMILES: CCCCC(=O)N(Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1)[C@H](C(=O)O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
Eligibility criteria:
Inclusion Criteria:

Participants over 18 years of age with hypertension defined as sitting systolic blood pressure between 140 mmHg and 180 mmHg or sitting diastolic blood pressure between 90 mmHg and 120 mmHg.
High risk participants ( defined as having: (diabetes mellitus, chronic renal disease, Framingham 10-year risk score >10%, established coronary artery disease (CAD), or CAD equivalents including carotid artery disease, peripheral arterial disease (PAD), abdominal aortic aneurysm (AAA))with hypertension defined as sitting systolic blood pressure between 130 mmHg and 180 mmHg or sitting diastolic blood pressure between 80 mmHg and 120 mmHg.

Exclusion Criteria:

Known or suspected secondary hypertension
Known New York Heart Association (NYHA) functional class IV Heart Failure
History of myocardial infarction, transient ischemic attack or cerebrovascular accident within the preceding 3 months
Clinically significant valvular disease
Women who are pregnant, intend to become pregnant or are breastfeeding
Participants who have severe medical condition(s) that in the view of the Investigator prohibits participation in the study
Participants who have hypersensitivity to the investigational/ reference drug or any of the components in the formulation.
Other protocol-defined inclusion/exclusion criteria may apply
Intervention: ESTRADIOL ACETATE
Trial phase: Phase 3
SMILES: [H][C@@]12CCc3cc(OC(C)=O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: 1 tablet daily containing 0.9 mg estradiol acetate
Eligibility criteria:
Inclusion Criteria:

Age ≥ 40 years of age; bilateral oophorectomy ≥ 35 years of age.

Non-hysterectomized women:

Amenorrhea for ≥ 12 months or
Amenorrhea for ≤ 12 months, but longer than 6 months, and serum FSH (follicle stimulating hormone) levels > 40 units/L and serum estradiol levels < 20 pg /mL,

Hysterectomized women:

Bilateral oophorectomy - subjects may enter the study 6 weeks after surgery or
History of removal of ovaries may be confirmed by - serum FSH levels > 40 units/L and serum estradiol levels < 20 pg/mL or via surgical report / ultrasound.
Seven or more moderate or severe hot flushes daily for 1 week or 60 or more moderate or severe flushes in 1 week during the 2 week screening period prior to study entry.

Exclusion Criteria:

Hormone therapy administered via the following routes and during the specified timeframes: oral within 8 weeks, vaginal (rings, creams, gels) within 1 week, transdermal within 4 weeks, intramuscular within 6 weeks, progestational implants, estrogen or estrogen/progestational injectable drug therapy within 3 months, estrogen pellet or progestational injectable within 6 months.
Abnormal Pap smear suggestive of low grade squamous intraepithelial lesion (LGSIL) or worse. Enrollment of subjects with an ASCUS (atypical squamous cells of undetermined significance) interpretation must be discussed with the sponsor prior to randomization.
Urinary tract infection
Congestive heart failure
Uncontrolled hypertension; sitting systolic BP ≥ 160 mmHg or diastolic ≥ 95 mmHg
History of stroke or transient ischemic attacks
Treatment with anticoagulants (heparin or warfarin).
Uncontrolled thyroid disorders.
Insulin-dependent diabetes mellitus.
Increase frequency or severity of headaches including migraines during previous estrogen therapy.
Intervention: Estradiol
Trial phase: Phase 3
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 84
Group description: 1 tablet daily containing 1 mg estradiol
Eligibility criteria:
Inclusion Criteria:

Age ≥ 40 years of age; bilateral oophorectomy ≥ 35 years of age.

Non-hysterectomized women:

Amenorrhea for ≥ 12 months or
Amenorrhea for ≤ 12 months, but longer than 6 months, and serum FSH (follicle stimulating hormone) levels > 40 units/L and serum estradiol levels < 20 pg /mL,

Hysterectomized women:

Bilateral oophorectomy - subjects may enter the study 6 weeks after surgery or
History of removal of ovaries may be confirmed by - serum FSH levels > 40 units/L and serum estradiol levels < 20 pg/mL or via surgical report / ultrasound.
Seven or more moderate or severe hot flushes daily for 1 week or 60 or more moderate or severe flushes in 1 week during the 2 week screening period prior to study entry.

Exclusion Criteria:

Hormone therapy administered via the following routes and during the specified timeframes: oral within 8 weeks, vaginal (rings, creams, gels) within 1 week, transdermal within 4 weeks, intramuscular within 6 weeks, progestational implants, estrogen or estrogen/progestational injectable drug therapy within 3 months, estrogen pellet or progestational injectable within 6 months.
Abnormal Pap smear suggestive of low grade squamous intraepithelial lesion (LGSIL) or worse. Enrollment of subjects with an ASCUS (atypical squamous cells of undetermined significance) interpretation must be discussed with the sponsor prior to randomization.
Urinary tract infection
Congestive heart failure
Uncontrolled hypertension; sitting systolic BP ≥ 160 mmHg or diastolic ≥ 95 mmHg
History of stroke or transient ischemic attacks
Treatment with anticoagulants (heparin or warfarin).
Uncontrolled thyroid disorders.
Insulin-dependent diabetes mellitus.
Increase frequency or severity of headaches including migraines during previous estrogen therapy.