anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sodium fluoride and triclosan
Trial phase: Phase 4
SMILES: Oc1cc(Cl)ccc1Oc1ccc(Cl)cc1Cl.[F-].[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 24
Group description: triclosan/copolymer/fluoride toothpaste
Eligibility criteria:
Inclusion Criteria:

Subjects must be adult males or females 18 to 60 years old
Subjects must be able and willing to follow study procedures and instructions
Subjects must have generalized, moderate plaque-associated gingivitis as determined by the Investigator or designee during the screening examination
Subjects must present with at least 20 teeth in the functional dentition, excluding third molars
Each subject must have at least four teeth with probing depths of 4-5 millimeters and at least 30% of sites bleeding to gentle probing

Exclusion Criteria:

Subjects who have chronically used (two weeks or more) Total (Triclosan/Copolymer) dentifrice within 6 months prior to enrollment
Subjects with gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue tumor of the oral cavity
Subjects with periodontitis as indicated by periodontal pocketing 6 millimeters at screening
Subjects with a history of early onset periodontitis or acute necrotizing ulcerative gingivitis
Subjects with concomitant endodontic or periodontal therapy other than prophylaxis within 6 months prior to enrollment
Subjects with orthodontic appliances or removable partial dentures
Subjects chronically treated (two weeks or more) with any medication known to affect inflammation or periodontal status or (aspirin, nonsteroidal anti-inflammatory drugs, steroids, statins, phenytoin, calcium antagonists, cyclosporin and coumadin) within one month of the screening examination. All other medications for chronic medical conditions should be initiated at least three months prior to enrollment
Subjects who currently smoke or who report using tobacco products within one year of screening.
Subjects who have been treated with antibiotics for medical or dental reasons within 3 months prior to enrollment
Subjects having clinically significant or unstable organic disease; subjects having compromised healing potential such as those with diabetes mellitus or connective tissue disorders; subjects having heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement necessitating antibiotic prophylaxis
Female subjects who report being pregnant
Subjects who use hormonal contraceptives must have started the method 30 days prior to the screening examination.
Subjects with active infectious diseases such as hepatitis, human immunodeficiency virus or Tuberculosis
Subjects diagnosed with human immunodeficiency virus (HIV) or subjects that are immunocompromised as determined by the Investigator
Medical condition which precludes not eating/drinking for approximately 8 hours.
Intervention: Fluoxetine
Trial phase: Phase 2
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Fluoxetine will be added starting at 20 mg and titrated as tolerated to 80 mg daily.

Fluoxetine:

Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-12 40mg BID
Eligibility criteria:
Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure
PAH of the following subtypes: idiopathic PAH WHO functional class II-III
Catheterization within one week showing mPAP >=25, wedge or LV end diastolic pressure ≤15, and PVR > 4 wood units, and baseline fick cardiac output results available
Age 16-75
Able to complete a six minute walk distance
Women of childbearing potential*: negative serum pre-treatment pregnancy test + consistently and correctly uses a reliable method of contraception** Oral approved PAH therapy for >3 months with no change in dose for > 1 month

Exclusion Criteria:

PAH with connective tissue disease, congenital heart disease, portal hypertension, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic telangiectasia, hemoglobinopathy, myeloproliferative disorders.
Moderate to severe obstructive or restrictive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 60% of predicted value after bronchodilator administration. -or- total lung capacity (TLC) < 60% of predicted.
Systemic systolic blood pressure <100 mmHg Breastfeeding
Significant liver, renal or other medical disease preventing completion of the study procedures or with life expectancy <12 months, or any other acute or chronic physical impairment (other than dyspnea), limiting the ability to comply with study requirements
Intervention: Montelukast Sodium
Trial phase: Not Applicable
SMILES: CC(C)(O)c1ccccc1CCC(SCC1(CC(=O)[O-])CC1)c1cccc(C=Cc2ccc3ccc(Cl)cc3n2)c1.[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 175
Group description: Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
Eligibility criteria:
Inclusion Criteria:

Patient is in good, stable health
Patient has been fed solid foods for at least 1 month
Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit
Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines

Exclusion Criteria:

Patient was hospitalized at the start of the study or required a visit to the emergency room due to asthma with in past 2 weeks
Intervention: Goserelin Acetate
Trial phase: Phase 3
SMILES: CC(=O)O.CC(C)CC(NC(=O)C(COC(C)(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(Cc1cnc[nH]1)NC(=O)C1CCC(=O)N1)C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)NNC(N)=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 283
Group description: Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
Eligibility criteria:
Inclusion Criteria:

18 years or older.
Has a histological confirmed prostate cancer Gleason graded).
Has a screening testosterone above 2.2 ng/mL.
Rising prostate-specific antigen (PSA).
Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2.
Has a life expectancy of at least one year.

Exclusion Criteria:

Current or previous hormone therapy.
Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening.
Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
Has a heart insufficiency.
Has a previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last five years.
Has a clinically significant medical condition (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.
Has received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial.
Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.
Intervention: Imiquimod
Trial phase: Phase 3
ATC code: D06BB10
SMILES: CC(C)Cn1cnc2c(N)nc3ccccc3c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 181
Group description: Imiquimod cream, 5%

Imiquimod: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
Eligibility criteria:
Inclusion Criteria:

Subjects were male or non-pregnant females, 18 years of age or older, in generally good health. Females who were post-menopausal, surgically sterile or using a medically acceptable form of birth control with a negative urine pregnancy test at the Baseline visit.
Subjects provided written and verbal informed consent.
Subjects presented to the clinic with at least 4 but no more than 12 visible, discrete nonhyperkeratotic, nonhypertrophic actinic keratosis lesions within a 25 cm2 Treatment Area on the face and/or anterior scalp.
Subjects were willing and able to comply with study instructions and return to the clinic for required visits.

Exclusion Criteria:

Subjects who were lactating, or planning to become pregnant during the study.
Subjects had hyperkeratotic, hypertrophic or large mat-like AKs within the 25 cm2 Treatment Area.
Subjects who had the need or were planning to be exposed to artificial tanning devices or excessive sunlight during the trial.
Subjects who were immunosuppressed (e.g., HIV, systemic malignancy, graft vs. host disease, etc.).
Subjects who experienced an unsuccessful outcome from previous imiquimod therapy.
Subjects with known hypersensitivity or previous allergic reaction to any of the active or inactive components of the study drugs.
Within 2 months: Facial and/or Anterior Scalp: laser resurfacing, photodynamic therapy, chemical peels, dermabrasion, topical application of 5-FU, imiquimod, diclofenac sodium or other treatments for AK or photodamage.
Subjects who used the following systemic, oral or topical therapies for the periods specified prior to entry into the study:

Within 2 days: Topicals of any kind to the selected Treatment Area. Within 2 weeks: Facial topical medications: corticosteroids, alpha- hydroxyacids (e.g., glycolic acid, lactic acid, etc. greater than 5%), beta-hydroxyacid (salicylic acid greater than 2%), urea - greater than 5% or prescription retinoids (e.g., tazarotene, adapalene, tretinoin) to the face and/or anterior scalp.

Within 2 weeks: Cryotherapy to lesions adjacent to or within the 25 cm2 Treatment Area.

Within 4 weeks: Systemic steroid therapy: chemotherapeutic agents, psoralens, immunotherapy, or retinoids.
Intervention: Imiquimod
Trial phase: Phase 3
ATC code: D06BB10
SMILES: CC(C)Cn1cnc2c(N)nc3ccccc3c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 179
Group description: Aldara™ (imiquimod) cream, 5%

Aldara™: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks
Eligibility criteria:
Inclusion Criteria:

Subjects were male or non-pregnant females, 18 years of age or older, in generally good health. Females who were post-menopausal, surgically sterile or using a medically acceptable form of birth control with a negative urine pregnancy test at the Baseline visit.
Subjects provided written and verbal informed consent.
Subjects presented to the clinic with at least 4 but no more than 12 visible, discrete nonhyperkeratotic, nonhypertrophic actinic keratosis lesions within a 25 cm2 Treatment Area on the face and/or anterior scalp.
Subjects were willing and able to comply with study instructions and return to the clinic for required visits.

Exclusion Criteria:

Subjects who were lactating, or planning to become pregnant during the study.
Subjects had hyperkeratotic, hypertrophic or large mat-like AKs within the 25 cm2 Treatment Area.
Subjects who had the need or were planning to be exposed to artificial tanning devices or excessive sunlight during the trial.
Subjects who were immunosuppressed (e.g., HIV, systemic malignancy, graft vs. host disease, etc.).
Subjects who experienced an unsuccessful outcome from previous imiquimod therapy.
Subjects with known hypersensitivity or previous allergic reaction to any of the active or inactive components of the study drugs.
Within 2 months: Facial and/or Anterior Scalp: laser resurfacing, photodynamic therapy, chemical peels, dermabrasion, topical application of 5-FU, imiquimod, diclofenac sodium or other treatments for AK or photodamage.
Subjects who used the following systemic, oral or topical therapies for the periods specified prior to entry into the study:

Within 2 days: Topicals of any kind to the selected Treatment Area. Within 2 weeks: Facial topical medications: corticosteroids, alpha- hydroxyacids (e.g., glycolic acid, lactic acid, etc. greater than 5%), beta-hydroxyacid (salicylic acid greater than 2%), urea - greater than 5% or prescription retinoids (e.g., tazarotene, adapalene, tretinoin) to the face and/or anterior scalp.

Within 2 weeks: Cryotherapy to lesions adjacent to or within the 25 cm2 Treatment Area.

Within 4 weeks: Systemic steroid therapy: chemotherapeutic agents, psoralens, immunotherapy, or retinoids.
Intervention: CALCIUM CHLORIDE
Trial phase: Phase 4
ATC code: A11GB01 | A12AA07 | B05XA07 | G04BA03
SMILES: [Ca+2].[Cl-].[Cl-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Calcium chloride, 10mg/kg

Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes
Eligibility criteria:
Inclusion Criteria:

Men and women greater than 18 years of age
Undergoing primary elective valve surgery at Brigham and Women's Hospital
Consented for Transesophogeal Echocardiography (TEE) as part of routine intra-operative care and monitoring

Exclusion Criteria:

Patients not consented for TEE as part of routine intra-operative care
Any absolute contraindication to TEE
Ionized calcium level < 0.80 mmol/L near separation from CPB
Myocardial infarction (MI) or acute coronary syndromes < 3 months prior to surgery due to the presence of pre-operative diastolic dysfunction in infarcted or ischemic myocardium
Ejection fraction (EF) < 35%
Atrial fibrillation / flutter the absence of an A wave on mitral inflow Doppler
Heart rate (HR) > 100 during 2 data point collections due to E / A wave superimposition
Intervention: Fentanyl
Trial phase: Phase 3
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
Eligibility criteria:
DISEASE CHARACTERISTICS:

Diagnosis of cancer and meets 1 of the following criteria:

Mild mucositis, defined as grade 1 (erythema of the mucosa) or 2 (patchy ulcerations or pseudomembranes) on the day of study drug administration.
No mucositis, defined as normal oral cavity upon examination on the day of study drug administration.
Opioid-tolerant, defined as patients who are taking ≥ 60 mg of oral morphine/day, ≥ 30 mg of oxycodone/day, ≥ 8 mg of oral hydromorphone/day, or an equianalgesic dose of another opioid for ≥ 7 days for cancer-related pain.
Persistent pain related to cancer or its treatment over the past 7 days.
No brain metastases with signs or symptoms of increased intracranial pressure.

PATIENT CHARACTERISTICS:

Negative pregnancy test.
Agree to be confined to study site for approximately 12 hours, to eat only the food served by the study unit during the study confinement period, and to consume all food provided at the designated meal or snack times.
No history of major organ system impairment or disease that, in the investigator's or his/her designee's opinion, could increase the risk associated with the use of opioids.
No uncontrolled hypertension despite antihypertensive therapy or history of hypertensive crisis within the past 2 years.
No recent history (within the past 2 years) of transient ischemic attacks, neural vascular disease, stroke, or cerebral aneurysms.
No intolerable side effects to opioids or fentanyl.

PRIOR CONCURRENT THERAPY:

See Disease Characteristics.
More than 30 days since prior investigational agents.
More than 14 days since prior monoamine oxidase inhibitors.
No prior participation in either Insys Fentanyl Sublingual Spray Phase III study INSYS-INS-05-001 or INSYS-INS-06-007.

No other concurrent use of any fentanyl product.

Patients who have received Actiq®, Fentora®, or Duragesic® are eligible after a 7-day washout.
No concurrent medications (prescription, over-the-counter, vitamin, or herbal substances) except for hormonal contraceptives and/or ≤ 3 doses of acetaminophen at ≤ 1 g each.
Intervention: Naloxone
Trial phase: Not Applicable
ATC code: A06AH04 | N02AA53 | N02AA55 | N02AX51 | V03AB15
SMILES: C=CCN1CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: 10mg/25ml Intravenous
Eligibility criteria:
Inclusion Criteria:

Male or female patient 50 years of age or older;
A diagnosis of COPD defined by American Thoracic Society-European Respiratory Society criteria
Current or former smoker with a smoking history of greater than or equal to 10 pack-years;
A post-bronchodilator forced expiratory volume in one second (FEV1) greater than or equal to 30% predicted and less than or equal to 80% predicted; AND
A post-bronchodilator FEV1/forced vital capacity ratio less than 70%; and clinically stable COPD.

Exclusion Criteria:

Any patient who has a concomitant disease that might interfere with study procedures or evaluation;
Inability to perform resistive breathing maneuvers; OR
Any current use of a narcotic medication.
Intervention: Montelukast Sodium
Trial phase: Phase 3
SMILES: CC(C)(O)c1ccccc1CCC(SCC1(CC(=O)[O-])CC1)c1cccc(C=Cc2ccc3ccc(Cl)cc3n2)c1.[Na+]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 326
Group description: Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
Eligibility criteria:
Inclusion Criteria:

Patient has a documented clinical history of seasonal allergic rhinitis symptoms that become worse during the study season
Patient is a non-smoker
Patient is in good mental and physical health

Exclusion Criteria:

Patient is hospitalized
Patient is a woman who is <8 weeks postpartum or is breast feeding
Patient intends to move or vacation away during the study
Patient is a current or past abuser of alcohol or illicit drugs
Intervention: Efavirenz
Trial phase: Phase 1
ATC code: J05AG03 | J05AR06 | J05AR11
SMILES: O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 30
Group description: On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
Eligibility criteria:
Inclusion Criteria:

Healthy adults 18-45 years of age
Non-smoking
Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures)
Body mass index (BMI) less than 30
Medically healthy on the basis of medical history and physical examination
Hemoglobin > or = to 12g/dL
Completion of the screening process within 28 days prior to dosing
Provision of voluntary written informed consent

Exclusion Criteria:

Recent participation (within 28 days) in other research studies
Recent significant blood donation or plasma donation
Pregnant or lactating
Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
Recent (2-year) history or evidence of alcoholism or drug abuse
History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
Drug allergies to fenofibric acid or efavirenz
Intervention: Lipoic acid
Trial phase: Phase 2
ATC code: A16AX01
SMILES: O=C(O)CCCCC1CCSS1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: alpha lipoic acid

lipoic acid: Subjects will be started on a single daily dose of 600 mg of alpha lipoic acid or placebo for the first 4 weeks and then increased to 1200 mg for the remainder of the study.
Eligibility criteria:
Inclusion Criteria:

diagnosis of CIDP
on a stable dose of immunotherapy for at least 3 months before enrolling in the study

Exclusion Criteria:

myelopathy or evidence of central demyelination
persistent neurological deficits from stroke, CNS trauma, or peripheral neuropathy from other causes (eg, diabetes mellitus, IgM, paraproteinaemia, or uraemic, toxic, or familial neuropathy)
evidence of systemic disease that might cause neuropathy
heart diseases (congestive heart failure or arrhythmia)
pulmonary conditions (asthma or CIPD)
rheumatoid conditions (such as rheumatoid arthritis)
renal failure
Intervention: Lipoic acid
Trial phase: Phase 2
ATC code: A16AX01
SMILES: O=C(O)CCCCC1CCSS1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: sugar pill

lipoic acid: Subjects will be started on a single daily dose of 600 mg of alpha lipoic acid or placebo for the first 4 weeks and then increased to 1200 mg for the remainder of the study.
Eligibility criteria:
Inclusion Criteria:

diagnosis of CIDP
on a stable dose of immunotherapy for at least 3 months before enrolling in the study

Exclusion Criteria:

myelopathy or evidence of central demyelination
persistent neurological deficits from stroke, CNS trauma, or peripheral neuropathy from other causes (eg, diabetes mellitus, IgM, paraproteinaemia, or uraemic, toxic, or familial neuropathy)
evidence of systemic disease that might cause neuropathy
heart diseases (congestive heart failure or arrhythmia)
pulmonary conditions (asthma or CIPD)
rheumatoid conditions (such as rheumatoid arthritis)
renal failure