anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Nitric Oxide
Trial phase: Phase 2
ATC code: R07AX01
SMILES: [N]=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM

Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM.
Eligibility criteria:
Inclusion Criteria:

An Institutional Review board (IRB) approved informed consent is signed, dated and timed prior to any study-related activities.
Male or female > 18 years of age.
Being evaluated for OHT or LVAD implantation and scheduled to undergo right heart catheterization to assess pulmonary vasoreactivity.
Have a confirmed diagnosis of heart failure, (NYHA Class III or IV)
Participant has the ability to understand the requirements of the study and a willingness to comply with all study procedures.
Females of childbearing potential with a negative urine pregnancy test, or a documented surgical sterilization, or is post-menopausal prior to administration of investigational product. Females of childbearing potential must be practicing adequate birth control to be eligible. It is the Investigator's responsibility to determine whether the Participant has adequate birth control for study participation.

Confirmed pulmonary arterial hypertension at time of RHC:

PAPm > 25mmHg at rest and PVR > 3 Wood units

Exclusion Criteria:

Be receiving an investigational drug, have in place an investigational device, or have participated in an investigational drug study within the past 30 days.
Have had an atrial septostomy.
Have anemia (hemoglobin <10 g/dL), active infection or any other ongoing condition that would interfere with the interpretation of study assessments.
Have any serious or life-threatening disease other than conditions (e.g. malignancy requiring aggressive chemotherapy, etc.).
Have unstable psychiatric status or be mentally incapable of understanding the objectives, nature or consequences of the trial, or any condition, which in the investigator's opinion would constitute an unacceptable risk to the participant's safety.
Participant is pregnant or lactating
Intervention: Caspofungin
Trial phase: Phase 2
ATC code: J02AX04
SMILES: CCC(C)CC(C)CCCCCCCCC(=O)NC1CC(O)C(NCCN)NC(=O)C2C(O)CCN2C(=O)C(C(O)CCN)NC(=O)C(C(O)C(O)c2ccc(O)cc2)NC(=O)C2CC(O)CN2C(=O)C(C(C)O)NC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 8
Group description: MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
Eligibility criteria:
Inclusion Criteria:

Japanese patients in whom a causative fungus is detected before treatment with the study drug or patients with strongly suspected deep-seated fungal infection due to Candida species (spp.) or Aspergillus spp.

Exclusion Criteria:

Patients with mycoses other than ones due to Candida spp. or Aspergillus spp.
Patients who will receive other systemic antifungal agents for the first time in screening period
Intervention: Dapsone
Trial phase: Phase 4
ATC code: D10AX05 | J04BA02 | J04BA50 | J04BA51
SMILES: Nc1ccc(S(=O)(=O)c2ccc(N)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 37
Group description: Dapsone 100 mg PO x 1 dose

Dapsone: 100 mg PO x 1 dose
Eligibility criteria:
Inclusion Criteria:

Male and female subjects, age >18 years, of all racial and ethnic origins.
Non-English speaking Spanish speakers will be included in the study.
We are recruiting 12 normal or underweight (BMI <25 kg/m2), 12 overweight or obese (BMI 25-40 kg/m2), and 12 extremely obese (BMI > 40 kg/m2) for this study. This index is calculated using the volunteer's height and weight (Formula: weight (lb) / [height (in)]2 x 703). Half of each group will be male; the other half will be female.

Exclusion Criteria:

Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of dapsone on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of dapsone, so that the pregnancy and post-partum state would be a confounding variable.
Abnormal liver function tests: transaminases>10 times upper limit of normal, Alkaline phosphatase>5 times upper limit of normal, total bilirubin>5 times upper limit of normal.
History of allergies to dapsone, sulfones, or sulfonamides.
Dapsone, sulfones, or sulfonamides are contraindicated for any reason.
Volunteers unwilling to comply with study procedures.
Current suspected or documented infection of any kind.
Volunteers with colon resection, gastric bypass, lap band, or any other conditions inhibiting gastric absorption of drug.
Current or previous participation within 28 days of enrollment in another research study that involves the use of medication, contrast, or any other compound that may alter blood count and/or blood chemistry (liver function, kidney function or electrolyte balance), unless waved by PI.
Donation of 450 milliliters (ml) (one unit) of blood or more within 8 weeks (56 days) prior to study enrollment, unless waved by PI.
Current use of zidovudine, amprenavir, rifabutin, rifapentine, or saquinavir.
Creatinine clearance < 70 ml/minute (min) as estimated by the Cockcroft-gault equation.
Intervention: Reltecimod
Trial phase: Phase 1
SMILES: CSCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@H](CO)NC(=O)[C@@H](C)N)C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](C(=O)N[C@@H](C)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(=O)O)C(=O)N[C@H](C)C(=O)O)C(C)C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: AB103 7.5 µg/kg administered as a single IV infusion
Eligibility criteria:
Inclusion Criteria:

Be able to read, understand and sign the Informed Consent form and be willing to participate in all study procedures for the duration of the study.
Be 18-to-40 years-of-age.
Have adequate venous access.
Have a body mass index between 20 and 29 kg/m2.
Have a history and physical examination that demonstrate no clinically significant contraindication for participating in the study, in the judgment of the admitting physician and/or the site investigator.
Have vital signs as follows: resting heart rate between 50 and 90 beats per minute (bpm), systolic blood pressure (BP) below 150 mm Hg and diastolic BP below 90 mm Hg.
Have all blood chemistry, hematology, coagulation, and urinalysis analyte levels within 10% of normal laboratory limits.
If female, not be pregnant or breast-feeding, nor plan to become pregnant for the duration of the study, have a negative pregnancy test.
Agree to exercise adequate birth control from the time of the screening procedures to 14 days after the investigational agent administration (both males and females).
Have an electrocardiogram (ECG) performed that demonstrates normal sinus rhythm, normal conductivity, and no clinically significant arrhythmias.

Exclusion Criteria:

Be pregnant or lactating.
Have autoimmune disease or asthma.
Have been febrile within 3-days of the first infusion.
Have a history of migraine headaches, as diagnosed by a physician.
Have any acute or chronic medical illnesses or other condition that, in the opinion of the Investigator, might jeopardize the safety of the patient, or the adequate evaluation of study results.
Be taking any medications to treat a chronic medical condition.
Have participated in a research study where they received any experimental products within 30 days prior to study entry.
Have ongoing drug abuse/dependence (including alcohol) by medical history.
Have taken, within 14 days of planned dosing, any prescription or non-prescription medication (including ibuprofen, aspirin, of non-steroidal anti-inflammatory drugs) unless the Principal Investigator/Sub-Investigator, in consultation with the Medical Monitor, provides a statement justifying that the medication taken will not impact the results of this study (with rare exceptions taking prescription drugs will be grounds for exclusion).
Have donated a unit of blood within the preceding 4-week period.
Have allergy to either sulfa- or penicillin-based drugs.
Have a history of vagal responses resulting in bradycardia.
Intervention: Reltecimod
Trial phase: Phase 1
SMILES: CSCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@H](CO)NC(=O)[C@@H](C)N)C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](C(=O)N[C@@H](C)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(=O)O)C(=O)N[C@H](C)C(=O)O)C(C)C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: AB103 37.5 µg/kg administered as a single IV infusion
Eligibility criteria:
Inclusion Criteria:

Be able to read, understand and sign the Informed Consent form and be willing to participate in all study procedures for the duration of the study.
Be 18-to-40 years-of-age.
Have adequate venous access.
Have a body mass index between 20 and 29 kg/m2.
Have a history and physical examination that demonstrate no clinically significant contraindication for participating in the study, in the judgment of the admitting physician and/or the site investigator.
Have vital signs as follows: resting heart rate between 50 and 90 beats per minute (bpm), systolic blood pressure (BP) below 150 mm Hg and diastolic BP below 90 mm Hg.
Have all blood chemistry, hematology, coagulation, and urinalysis analyte levels within 10% of normal laboratory limits.
If female, not be pregnant or breast-feeding, nor plan to become pregnant for the duration of the study, have a negative pregnancy test.
Agree to exercise adequate birth control from the time of the screening procedures to 14 days after the investigational agent administration (both males and females).
Have an electrocardiogram (ECG) performed that demonstrates normal sinus rhythm, normal conductivity, and no clinically significant arrhythmias.

Exclusion Criteria:

Be pregnant or lactating.
Have autoimmune disease or asthma.
Have been febrile within 3-days of the first infusion.
Have a history of migraine headaches, as diagnosed by a physician.
Have any acute or chronic medical illnesses or other condition that, in the opinion of the Investigator, might jeopardize the safety of the patient, or the adequate evaluation of study results.
Be taking any medications to treat a chronic medical condition.
Have participated in a research study where they received any experimental products within 30 days prior to study entry.
Have ongoing drug abuse/dependence (including alcohol) by medical history.
Have taken, within 14 days of planned dosing, any prescription or non-prescription medication (including ibuprofen, aspirin, of non-steroidal anti-inflammatory drugs) unless the Principal Investigator/Sub-Investigator, in consultation with the Medical Monitor, provides a statement justifying that the medication taken will not impact the results of this study (with rare exceptions taking prescription drugs will be grounds for exclusion).
Have donated a unit of blood within the preceding 4-week period.
Have allergy to either sulfa- or penicillin-based drugs.
Have a history of vagal responses resulting in bradycardia.
Intervention: Reltecimod
Trial phase: Phase 1
SMILES: CSCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@H](CO)NC(=O)[C@@H](C)N)C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](C(=O)N[C@@H](C)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(=O)O)C(=O)N[C@H](C)C(=O)O)C(C)C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: AB103 150 µg/kg administered as a single IV infusion
Eligibility criteria:
Inclusion Criteria:

Be able to read, understand and sign the Informed Consent form and be willing to participate in all study procedures for the duration of the study.
Be 18-to-40 years-of-age.
Have adequate venous access.
Have a body mass index between 20 and 29 kg/m2.
Have a history and physical examination that demonstrate no clinically significant contraindication for participating in the study, in the judgment of the admitting physician and/or the site investigator.
Have vital signs as follows: resting heart rate between 50 and 90 beats per minute (bpm), systolic blood pressure (BP) below 150 mm Hg and diastolic BP below 90 mm Hg.
Have all blood chemistry, hematology, coagulation, and urinalysis analyte levels within 10% of normal laboratory limits.
If female, not be pregnant or breast-feeding, nor plan to become pregnant for the duration of the study, have a negative pregnancy test.
Agree to exercise adequate birth control from the time of the screening procedures to 14 days after the investigational agent administration (both males and females).
Have an electrocardiogram (ECG) performed that demonstrates normal sinus rhythm, normal conductivity, and no clinically significant arrhythmias.

Exclusion Criteria:

Be pregnant or lactating.
Have autoimmune disease or asthma.
Have been febrile within 3-days of the first infusion.
Have a history of migraine headaches, as diagnosed by a physician.
Have any acute or chronic medical illnesses or other condition that, in the opinion of the Investigator, might jeopardize the safety of the patient, or the adequate evaluation of study results.
Be taking any medications to treat a chronic medical condition.
Have participated in a research study where they received any experimental products within 30 days prior to study entry.
Have ongoing drug abuse/dependence (including alcohol) by medical history.
Have taken, within 14 days of planned dosing, any prescription or non-prescription medication (including ibuprofen, aspirin, of non-steroidal anti-inflammatory drugs) unless the Principal Investigator/Sub-Investigator, in consultation with the Medical Monitor, provides a statement justifying that the medication taken will not impact the results of this study (with rare exceptions taking prescription drugs will be grounds for exclusion).
Have donated a unit of blood within the preceding 4-week period.
Have allergy to either sulfa- or penicillin-based drugs.
Have a history of vagal responses resulting in bradycardia.
Intervention: Reltecimod
Trial phase: Phase 1
SMILES: CSCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@H](CO)NC(=O)[C@@H](C)N)C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](C(=O)N[C@@H](C)C(=O)N[C@@H](Cc1ccc(O)cc1)C(=O)N[C@@H](CC(=O)O)C(=O)N[C@H](C)C(=O)O)C(C)C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 5
Group description: AB103 450 µg/kg administered as a single IV infusion
Eligibility criteria:
Inclusion Criteria:

Be able to read, understand and sign the Informed Consent form and be willing to participate in all study procedures for the duration of the study.
Be 18-to-40 years-of-age.
Have adequate venous access.
Have a body mass index between 20 and 29 kg/m2.
Have a history and physical examination that demonstrate no clinically significant contraindication for participating in the study, in the judgment of the admitting physician and/or the site investigator.
Have vital signs as follows: resting heart rate between 50 and 90 beats per minute (bpm), systolic blood pressure (BP) below 150 mm Hg and diastolic BP below 90 mm Hg.
Have all blood chemistry, hematology, coagulation, and urinalysis analyte levels within 10% of normal laboratory limits.
If female, not be pregnant or breast-feeding, nor plan to become pregnant for the duration of the study, have a negative pregnancy test.
Agree to exercise adequate birth control from the time of the screening procedures to 14 days after the investigational agent administration (both males and females).
Have an electrocardiogram (ECG) performed that demonstrates normal sinus rhythm, normal conductivity, and no clinically significant arrhythmias.

Exclusion Criteria:

Be pregnant or lactating.
Have autoimmune disease or asthma.
Have been febrile within 3-days of the first infusion.
Have a history of migraine headaches, as diagnosed by a physician.
Have any acute or chronic medical illnesses or other condition that, in the opinion of the Investigator, might jeopardize the safety of the patient, or the adequate evaluation of study results.
Be taking any medications to treat a chronic medical condition.
Have participated in a research study where they received any experimental products within 30 days prior to study entry.
Have ongoing drug abuse/dependence (including alcohol) by medical history.
Have taken, within 14 days of planned dosing, any prescription or non-prescription medication (including ibuprofen, aspirin, of non-steroidal anti-inflammatory drugs) unless the Principal Investigator/Sub-Investigator, in consultation with the Medical Monitor, provides a statement justifying that the medication taken will not impact the results of this study (with rare exceptions taking prescription drugs will be grounds for exclusion).
Have donated a unit of blood within the preceding 4-week period.
Have allergy to either sulfa- or penicillin-based drugs.
Have a history of vagal responses resulting in bradycardia.
Intervention: Prasugrel
Trial phase: Phase 2
ATC code: B01AC22
SMILES: CC(=O)Oc1cc2c(s1)CCN(C(C(=O)C1CC1)c1ccccc1F)C2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Participants received 5 mg of prasugrel orally, once daily for 30 days.
Eligibility criteria:
Inclusion Criteria:

Adults with Sickle Cell Disease (SCD).
Are greater than or equal to 50 kilograms (kg) at time of screening.
Are not currently being treated with an investigational drug (use of hydroxyurea, which is not an investigational drug, is permitted under this protocol if the patient has been on a stable dose for at least 30 days prior to randomization and has no signs of hematological toxicity at screening.
Agree to use a reliable method of birth control during the study or are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.

Exclusion Criteria:

Acute painful crisis (requiring medical attention) within 30 days prior to screening.
Have a concomitant medical illness (for example, terminal malignancy) that, in the opinion of the investigator, is associated with reduced survival over the expected treatment period (approximately 30 days).
Severe hepatic dysfunction (cirrhosis, portal hypertension, or aspartate aminotransferase (AST) greater than or equal to 3x upper limit of normal [ULN]).
Renal dysfunction requiring chronic dialysis.
Contraindication for antiplatelet therapy.
History of intolerance or allergy to approved thienopyridines.
Have signs or symptoms of an infection.
Hypertension (systolic blood pressure >180 millimeters of mercury (mm Hg) or diastolic blood pressure >110 mm Hg) at the time of screening or randomization.
Hematocrit <18%.
Any history of bleeding diathesis, bleeding requiring in-hospital treatment, or papillary necrosis.
Active internal bleeding.
History of spontaneous gastrointestinal (GI) bleeding requiring in-hospital treatment.
Gross hematuria. Microhematuria, common in SCD patients, is not a contraindication.
Platelet count <100,000 per cubic millimeter.
Any history of intraocular hemorrhage.
Prior history of transient ischemic attack (TIA), ischemic stroke, hemorrhagic stroke, or other intracranial hemorrhage.
Known history of intracranial neoplasm, arteriovenous malformation, or aneurysm.
Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding.
Have an international normalized ratio (INR) of greater than 1.5 at screening.
Have had recent surgery (within 30 days prior to screening) or are scheduled to undergo surgery within the next 60 days.
History of menorrhagia requiring medical intervention.
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: 282
Group description: Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Male and female adult outpatients had uncontrolled hypertension at both screening and randomization despite current antihypertensive monotherapy (initial dose of Angiotensin Receptor Blockers (ARB), Angiotensin Converting Enzyme Inhibitors (ACEI), Calcium Channel Blockers (CCB), diuretics or β receptor blocker)

Exclusion Criteria:

Systolic BP (SBP) level ≥160 mm Hg (≥160 mm Hg in diabetics) or a diastolic BP (DBP) level ≥110 mm Hg (≥100 mm Hg in diabetics) at any time between screening and randomization.
Patients with type 1 diabetes or poorly controlled type 2 diabetes (glycosylated hemoglobin >8.0%)
Patients had evidence of hepatic disease or renal impairment
Other exclusion criteria included evidence of secondary hypertension or history of cardio-vascular disease.
Women who were pregnant, nursing, or of childbearing potential and not using acceptable contraception.

Other protocol-defined inclusion/exclusion criteria applied.
Intervention: Nifedipine
Trial phase: Phase 4
ATC code: C07FB03 | C08CA05 | C08CA55 | C08GA01
SMILES: COC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1c1ccccc1[N+](=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 282
Group description: Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Male and female adult outpatients had uncontrolled hypertension at both screening and randomization despite current antihypertensive monotherapy (initial dose of Angiotensin Receptor Blockers (ARB), Angiotensin Converting Enzyme Inhibitors (ACEI), Calcium Channel Blockers (CCB), diuretics or β receptor blocker)

Exclusion Criteria:

Systolic BP (SBP) level ≥160 mm Hg (≥160 mm Hg in diabetics) or a diastolic BP (DBP) level ≥110 mm Hg (≥100 mm Hg in diabetics) at any time between screening and randomization.
Patients with type 1 diabetes or poorly controlled type 2 diabetes (glycosylated hemoglobin >8.0%)
Patients had evidence of hepatic disease or renal impairment
Other exclusion criteria included evidence of secondary hypertension or history of cardio-vascular disease.
Women who were pregnant, nursing, or of childbearing potential and not using acceptable contraception.

Other protocol-defined inclusion/exclusion criteria applied.