anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: ALBUTEROL
Trial phase: Phase 4
ATC code: R03AC02 | R03AK04 | R03AK13 | R03AL02 | R03CC02
SMILES: CC(C)(C)NCC(O)c1ccc(O)c(CO)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 81
Group description: Increasing doses of albuterol by MDI and nebulizer solution
Eligibility criteria:
Eligibility Criteria:

Well-defined history of physician diagnosed asthma
Any ethnic background
8 to 65 years old
Baseline pre-bronchodilator FEV1 of 40% to 80% predicted for age, height, and gender
No oral corticosteroid use, emergency room visits, or hospitalizations within the previous 3 months
Nonsmokers or less than a 5 pack-year history with no smoking in the previous year
Normal physical exam and no confounding diseases were selected
Able to withhold inhaled short-acting b2-agonists or inhaled anticholinergic drugs for 8 hours, oral antihistamines for 5 days, theophylline for 24 hours, and cromolyn, nedocromil, and inhaled corticosteroids for 2 hours prior to the study.
Intervention: SCH-900271
Trial phase: Phase 2
SMILES: CC1(CCCc2cc(=O)oc3[nH]c(=O)[nH]c(=O)c23)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 103
Group description: Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Adults of either sex 18 to 75 years of age, inclusive, with a diagnosis of primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia (increased LDL-C and triglycerides [TG])
must be free of any clinically significant disease, other than primary hypercholesterolemia or mixed hyperlipidemia that would knowingly interfere with study evaluations
must be willing to adhere to dietary recommendations, protocol requirements, and provide written informed consent

Exclusion Criteria:

The participant will be excluded from entry if ANY of the criteria listed below are met:

use of any investigational drug within 30 days of study entry
female of childbearing potential or lactating
postmenopausal (or perimenopausal) woman who is currently experiencing hot flashes (e.g. within 30 days of study entry
homozygous familial hypercholesterolemia
congestive heart failure New York Heart Association (NYHA) Class III or IV
uncontrolled hypertension on or off therapy
cardiac arrhythmia requiring medication
clinical atherosclerotic disease that confers high risk for coronary heart disease (CHD) events (e.g. clinical CHD, symptomatic carotid artery disease, peripheral arterial disease, abdominal aortic aneurysm)
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
history of mental instability, drug/alcohol abuse or who has been treated or is being treated for severe psychiatric illness, which in the opinion of the investigator, may interfere with optimal participation in the study
gastrointestinal ulcer within 3 months of study entry
history of coagulopathy
history of gout
known active or chronic hepatic or biliary disease.
known significant impairment of renal function, dysproteinemia, nephrotic syndrome, or other renal disease
body mass index >40 kg/m^2
taking non-steroidal anti-inflammatory drugs (NSAIDS) (acetaminophen and cyclooxygenase-2 [COX-2] inhibitors are allowed)
taking more than 100 mg aspirin per day
being treated with corticosteroids (oral, intramuscular, or intravascular)
more than 3 alcoholic beverages per day or its equivalent (one drink equals 1.5 ounces of 80 proof liquor or equivalent) during study participation
Intervention: SCH-900271
Trial phase: Phase 2
SMILES: CC1(CCCc2cc(=O)oc3[nH]c(=O)[nH]c(=O)c23)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Adults of either sex 18 to 75 years of age, inclusive, with a diagnosis of primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia (increased LDL-C and triglycerides [TG])
must be free of any clinically significant disease, other than primary hypercholesterolemia or mixed hyperlipidemia that would knowingly interfere with study evaluations
must be willing to adhere to dietary recommendations, protocol requirements, and provide written informed consent

Exclusion Criteria:

The participant will be excluded from entry if ANY of the criteria listed below are met:

use of any investigational drug within 30 days of study entry
female of childbearing potential or lactating
postmenopausal (or perimenopausal) woman who is currently experiencing hot flashes (e.g. within 30 days of study entry
homozygous familial hypercholesterolemia
congestive heart failure New York Heart Association (NYHA) Class III or IV
uncontrolled hypertension on or off therapy
cardiac arrhythmia requiring medication
clinical atherosclerotic disease that confers high risk for coronary heart disease (CHD) events (e.g. clinical CHD, symptomatic carotid artery disease, peripheral arterial disease, abdominal aortic aneurysm)
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
history of mental instability, drug/alcohol abuse or who has been treated or is being treated for severe psychiatric illness, which in the opinion of the investigator, may interfere with optimal participation in the study
gastrointestinal ulcer within 3 months of study entry
history of coagulopathy
history of gout
known active or chronic hepatic or biliary disease.
known significant impairment of renal function, dysproteinemia, nephrotic syndrome, or other renal disease
body mass index >40 kg/m^2
taking non-steroidal anti-inflammatory drugs (NSAIDS) (acetaminophen and cyclooxygenase-2 [COX-2] inhibitors are allowed)
taking more than 100 mg aspirin per day
being treated with corticosteroids (oral, intramuscular, or intravascular)
more than 3 alcoholic beverages per day or its equivalent (one drink equals 1.5 ounces of 80 proof liquor or equivalent) during study participation
Intervention: SCH-900271
Trial phase: Phase 2
SMILES: CC1(CCCc2cc(=O)oc3[nH]c(=O)[nH]c(=O)c23)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 104
Group description: Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Adults of either sex 18 to 75 years of age, inclusive, with a diagnosis of primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia (increased LDL-C and triglycerides [TG])
must be free of any clinically significant disease, other than primary hypercholesterolemia or mixed hyperlipidemia that would knowingly interfere with study evaluations
must be willing to adhere to dietary recommendations, protocol requirements, and provide written informed consent

Exclusion Criteria:

The participant will be excluded from entry if ANY of the criteria listed below are met:

use of any investigational drug within 30 days of study entry
female of childbearing potential or lactating
postmenopausal (or perimenopausal) woman who is currently experiencing hot flashes (e.g. within 30 days of study entry
homozygous familial hypercholesterolemia
congestive heart failure New York Heart Association (NYHA) Class III or IV
uncontrolled hypertension on or off therapy
cardiac arrhythmia requiring medication
clinical atherosclerotic disease that confers high risk for coronary heart disease (CHD) events (e.g. clinical CHD, symptomatic carotid artery disease, peripheral arterial disease, abdominal aortic aneurysm)
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
history of mental instability, drug/alcohol abuse or who has been treated or is being treated for severe psychiatric illness, which in the opinion of the investigator, may interfere with optimal participation in the study
gastrointestinal ulcer within 3 months of study entry
history of coagulopathy
history of gout
known active or chronic hepatic or biliary disease.
known significant impairment of renal function, dysproteinemia, nephrotic syndrome, or other renal disease
body mass index >40 kg/m^2
taking non-steroidal anti-inflammatory drugs (NSAIDS) (acetaminophen and cyclooxygenase-2 [COX-2] inhibitors are allowed)
taking more than 100 mg aspirin per day
being treated with corticosteroids (oral, intramuscular, or intravascular)
more than 3 alcoholic beverages per day or its equivalent (one drink equals 1.5 ounces of 80 proof liquor or equivalent) during study participation
Intervention: SCH-900271
Trial phase: Phase 2
SMILES: CC1(CCCc2cc(=O)oc3[nH]c(=O)[nH]c(=O)c23)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 104
Group description: Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Adults of either sex 18 to 75 years of age, inclusive, with a diagnosis of primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia (increased LDL-C and triglycerides [TG])
must be free of any clinically significant disease, other than primary hypercholesterolemia or mixed hyperlipidemia that would knowingly interfere with study evaluations
must be willing to adhere to dietary recommendations, protocol requirements, and provide written informed consent

Exclusion Criteria:

The participant will be excluded from entry if ANY of the criteria listed below are met:

use of any investigational drug within 30 days of study entry
female of childbearing potential or lactating
postmenopausal (or perimenopausal) woman who is currently experiencing hot flashes (e.g. within 30 days of study entry
homozygous familial hypercholesterolemia
congestive heart failure New York Heart Association (NYHA) Class III or IV
uncontrolled hypertension on or off therapy
cardiac arrhythmia requiring medication
clinical atherosclerotic disease that confers high risk for coronary heart disease (CHD) events (e.g. clinical CHD, symptomatic carotid artery disease, peripheral arterial disease, abdominal aortic aneurysm)
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
history of mental instability, drug/alcohol abuse or who has been treated or is being treated for severe psychiatric illness, which in the opinion of the investigator, may interfere with optimal participation in the study
gastrointestinal ulcer within 3 months of study entry
history of coagulopathy
history of gout
known active or chronic hepatic or biliary disease.
known significant impairment of renal function, dysproteinemia, nephrotic syndrome, or other renal disease
body mass index >40 kg/m^2
taking non-steroidal anti-inflammatory drugs (NSAIDS) (acetaminophen and cyclooxygenase-2 [COX-2] inhibitors are allowed)
taking more than 100 mg aspirin per day
being treated with corticosteroids (oral, intramuscular, or intravascular)
more than 3 alcoholic beverages per day or its equivalent (one drink equals 1.5 ounces of 80 proof liquor or equivalent) during study participation
Intervention: SCH-900271
Trial phase: Phase 2
SMILES: CC1(CCCc2cc(=O)oc3[nH]c(=O)[nH]c(=O)c23)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Adults of either sex 18 to 75 years of age, inclusive, with a diagnosis of primary hypercholesterolemia (familial and nonfamilial) or mixed hyperlipidemia (increased LDL-C and triglycerides [TG])
must be free of any clinically significant disease, other than primary hypercholesterolemia or mixed hyperlipidemia that would knowingly interfere with study evaluations
must be willing to adhere to dietary recommendations, protocol requirements, and provide written informed consent

Exclusion Criteria:

The participant will be excluded from entry if ANY of the criteria listed below are met:

use of any investigational drug within 30 days of study entry
female of childbearing potential or lactating
postmenopausal (or perimenopausal) woman who is currently experiencing hot flashes (e.g. within 30 days of study entry
homozygous familial hypercholesterolemia
congestive heart failure New York Heart Association (NYHA) Class III or IV
uncontrolled hypertension on or off therapy
cardiac arrhythmia requiring medication
clinical atherosclerotic disease that confers high risk for coronary heart disease (CHD) events (e.g. clinical CHD, symptomatic carotid artery disease, peripheral arterial disease, abdominal aortic aneurysm)
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
history of mental instability, drug/alcohol abuse or who has been treated or is being treated for severe psychiatric illness, which in the opinion of the investigator, may interfere with optimal participation in the study
gastrointestinal ulcer within 3 months of study entry
history of coagulopathy
history of gout
known active or chronic hepatic or biliary disease.
known significant impairment of renal function, dysproteinemia, nephrotic syndrome, or other renal disease
body mass index >40 kg/m^2
taking non-steroidal anti-inflammatory drugs (NSAIDS) (acetaminophen and cyclooxygenase-2 [COX-2] inhibitors are allowed)
taking more than 100 mg aspirin per day
being treated with corticosteroids (oral, intramuscular, or intravascular)
more than 3 alcoholic beverages per day or its equivalent (one drink equals 1.5 ounces of 80 proof liquor or equivalent) during study participation
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Patients who are in the control group received a placebo of saline at initial date, 2 months and 6 months.
Eligibility criteria:
Inclusion Criteria:

≥18 years of age;
HIV positive status;
CD4 > 200 and viral RNA < 400 on anti-retroviral therapy (HAART) or CD4 > 350 if not on HARRT;
the presence of anal warts that require surgical excision/ablation.

Exclusion Criteria:

CD4 < 200 and/or viral RNA > 400 on HAART or CD4 < 350 and not on HAART ;
low burden of anal warts that would not require surgical excision/ablation;
previous vaccinations against HPV or allergic reactions to any vaccine component;
patients who are currently pregnant;
patients with a previous diagnosis of anal cancer;
patients who are incarcerated;
patients who have taken immunomodulators (i.e. interferon, interleukin, corticosteroids, etc.) within the last 90 days;
patients who have had an opportunistic infection in the last 90 days or who have another intercurrent illness that precludes their safe enrollment in this study;
patients who, in the judgment of the investigators, are unlikely to adhere to the protocol, either because of a substance abuse or psychiatric diagnosis, or other factors that would affect compliance;
failure to strictly comply with the vaccination schedule.
Intervention: Acyclovir
Trial phase: Phase 1
ATC code: D06BB03 | D06BB53 | J05AB01 | S01AD03
SMILES: Nc1nc2c(ncn2COCCO)c(=O)[nH]1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 32
Group description: Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
Eligibility criteria:
The investigator or other study site personnel will document in the source documents (e.g., the hospital chart) that informed consent was obtained. Laboratory tests or non-pharmacologic treatment procedures that were performed as standard of care within 72 hours prior to first dose of study drug may be used for screening procedures and recorded in the CRF.

Inclusion Criteria

< 45 days of age at the time of initial study drug administration.
Sufficient venous access to permit administration of study medication.
Availability and willingness of the parent/legal guardian to provide written informed consent.

Suspected HSV sepsis OR At least two (2) of the following

Signs of sepsis AND negative blood cultures for >24 hours7
Respiratory distress8
Lethargy8
Fever ≥ 38.0°C7
Skin lesions7,8
Seizures (clinical OR EEG confirmed)7
Irritability7
AST OR ALT >2 X upper limit of normal7,8
>20 WBCs/µL or >500 RBCs/µL7

Exclusion Criteria

History of anaphylaxis attributed to acyclovir.
Serum creatinine >1.7 mg/dL.
Urine output <0.5 mL/kg/hour over the previous 12 hours
Previous participation in the study.
Concomitant condition, which in the opinion of the investigator would preclude a participant's participation in the study
Intervention: CID 23581946
Trial phase: Phase 3
ATC code: D06BX02
SMILES: CC=C(C)C(=O)OC1C(C)=CC23C(=O)C(C=C(CO)C(O)C12O)C1C(CC3C)C1(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
Eligibility criteria:
Inclusion Criteria:

Must be male or female and at least 18 years of age.
Female patients must be of:
Non-childbearing potential;
Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception.
4 to 8 AK lesions on non-head locations.

Exclusion Criteria:

Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area.
Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks.
Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 8 weeks and 2 cm of treatment area
Intervention: Aliskiren/amlodipine
Trial phase: Phase 4
SMILES: CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1c1ccccc1Cl.COCCCOc1cc(CC(CC(N)C(O)CC(C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 209
Group description: At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
Eligibility criteria:
Inclusion Criteria:

Patients who are newly diagnosed or have a history of hypertension, who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
Men or women 18 years and older of minority background; self-identified.
Patients with stage 2 hypertension defined as MSSBP ≥160 mmHg and <200 mmHg at Visit 5 (randomization).

Exclusion Criteria:

Patients with MSDBP ≥110 mmHg and/or MSSBP ≥200 mmHg as measured by office cuff at any visit.
Patients on 4 or more antihypertensive medications.
Patients with uncontrolled hypertension (MSSBP >180 mmHg) taking more than 1 antihypertensive medication at Visit 1.
Intervention: Pretomanid
Trial phase: Phase 2
ATC code: J04AK08
SMILES: O=[N+]([O-])c1cn2c(n1)OC[C@@H](OCc1ccc(OC(F)(F)F)cc1)C2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 15
Group description: PA-824 : 50mg oral tablet
Eligibility criteria:
Inclusion Criteria:

Informed Consent
Body weight between 40 and 90 kg, inclusive.
Newly diagnosed, previously untreated, uncomplicated, sputum smear-positive, pulmonary TB.
A chest X-ray compatible with TB.
Sputum positive
Adequate volume of sputum
Female participants of childbearing potential negative serum pregnancy and agree to use birth control
Male participants must agree to use contraception throughout participation in the trial and for 12 weeks after last dose.

Exclusion Criteria:

Poor general condition
Rifampicin-resistant and/or Isoniazid-resistant
MTB Treatment received within the 3 months prior
Allergy to the IMP or related substances
Evidence of extrathoracic TB
A history of previous TB
Evidence of serious lung conditions other than TB or uncontrolled obstructive bronchial disease
History of lens opacity or evidence of lens opacity on slit lamp ophthalmologic examination
Any evidence of renal impairment
For males, any evidence or history of abnormality in the reproductive system
History and/or presence (or evidence) of neuropathy or epilepsy.
Clinically relevant changes in the ECG
A history of or current clinically relevant cardiovascular disorder
Concomitant use of any drug known to prolong QTc interval
Diabetics using insulin
Evidence of clinically significant metabolic, gastrointestinal, neurological, psychiatric or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied).
Any diseases or conditions in which the use of the standard TB drugs or any of their components is contra-indicated, including but not limited to allergy to any TB drug, their component or to the IMP.
Any disease or conditions in which any of the medicinal products listed in the section pertaining to prohibited medication is used.
alcohol or drug abuse
Administration of an IMP prior to Visit 1, within 5 half-lives for that IMP if known. If the half-life of the IMP is unknown within 1 month.
Pregnant, breast-feeding, or planning to conceive or father a child within twelve weeks of cessation of treatment for males and within one week of cessation of treatment for females.
Use of any drugs or substances within 30 days prior to dosing known to be strong inhibitors or inducers of cytochrome P450 enzymes
Any therapeutic agents known to alter any major organ function (e.g., barbiturates, opiates, phenothiazines, cimetidine) within 30 days prior to dosing.
glucocorticoids within one year prior to dosing.
HIV infection with helper/inducer T lymphocyte (CD4 cell) count of less than or equal to 300x10-6/L.
Receiving antiretroviral therapy (ART).