anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Duloxetine Hydrochloride
Trial phase: Phase 4
SMILES: CNCCC(Oc1cccc2ccccc12)c1cccs1.Cl
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 249
Group description: Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
Eligibility criteria:
Inclusion Criteria:

Are male or female outpatients at least 65 years of age who meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder (MDD)
Have a Mini Mental Score Exam (MMSE) score of at least 20 at Visit 1
Have a degree of understanding such that the patient can communicate intelligibly with the investigator and study coordinator

Exclusion Criteria:

Patients judged clinically to be at serious suicidal risk in the opinion of the investigator
Have any prior history of bipolar disorder, panic disorder, psychosis, schizophrenia, or obsessive-compulsive disorder
Have any current (within the past 12 months) DSM-IV-TR primary Axis I diagnosis other than MDD
Have moderate to severe dementia
Have a serious medical illness, including any cardiovascular (CV), hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the investigator
Intervention: LITHIUM CARBONATE
Trial phase: Not Applicable
SMILES: O=C([O-])[O-].[Li+].[Li+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
Eligibility criteria:
Inclusion Criteria:

Patient with a diagnosis of severe intestinal GVHD that is not improving at any time after initial treatment with glucocorticoids for at least 7 days are eligible for enrollment; measures indicating severity of GVHD will include: a) persistent diarrhea with average daily stool volumes > 500 mL per day; or b) persistent hemorrhage that is detectable by visual inspection of the stool
Patients with denuded mucosa caused by GVHD are eligible for enrollment, regardless of prior treatment for acute GVHD; denuded mucosa is defined as loss (i.e., erosion or sloughing) of the epithelium in: a) at least one-third of the surface area in a 30 cm colonic segment (i.e., rectosigmoid, descending or transverse colon); or b) at least one fifth of the surface area of the second portion of the duodenum, as estimated by endoscopic evaluation; denuded mucosa must be documented by images of the duodenum and colon and by histologic evaluation of the colon
All subjects must provide written informed consent with the use of forms approved by the Fred Hutchinson Cancer Research Center (FHCRC) Institutional Review Board (IRB)

Exclusion Criteria:

Significant renal dysfunction (estimated creatinine clearance < 30 mL/min)
Persistent or recurrent malignancy
Secondary malignancy
Patients who had autologous or syngeneic marrow transplantation
Presence of any cause of intestinal symptoms or ulceration other than GVHD
Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol will be excluded
Intervention: Palonosetron
Trial phase: Phase 1 | Phase 2
ATC code: A04AA05 | A04AA55
SMILES: [H][C@]12CCCc3cccc(c31)C(=O)N([C@@H]1CN3CCC1CC3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: 2 Days Palonosetron 0.25 mg IV
Eligibility criteria:
Inclusion Criteria:

They have non-resectable stage III or IV metastatic melanoma with measurable disease and have agreed to be treated with biochemotherapy.
They have Zubrod performance status of 0-1
They have normal blood counts with a white blood count (WBC) count >/= 3,500/mm^3, ANC >/= 1,500/mm^3 and a platelet count >/= 100,000/mm^3 and have serum creatinine <1.5 mg/dl, and serum bilirubin level < 1.5 mg/dl, and no evidence of significant cardiac or pulmonary dysfunction.
They have no significant intercurrent illness such as a serious infection, significant psychiatric illness, hypercalcemia (calcium >11 mg), gastro-intestinal (GI) bleeding or evidence of brain metastasis.
They have not been exposed to prior interferon, interleukin-2 or previous chemotherapy including regional perfusion. Prior radiation therapy for metastatic melanoma is permitted provided the patient has unirradiated metastatic sites for response evaluation and has fully recovered from its toxicity.
They must have been off corticosteroids for at least 2 weeks.

Exclusion Criteria:

They are younger than 18 years or more than 65 years of age and those with an expected survival of less than 8 weeks or a Zubrod performance status of 2, 3 or 4.
They have received previous treatment with any prior systemic chemotherapy for unresectable metastasis including and not limited to the following drugs: cisplatin, vinblastine, Dacarbazine (DTIC), interferon and interleukin-2
They have active central nervous system involvement by melanoma either as brain metastasis, spinal cord compression, or meningeal carcinomatosis".
They have significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricular function or serious cardiac arrhythmias requiring therapy.
They have significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD).
They have symptomatic effusions on account of pleural, pericardial or peritoneal metastasis of melanoma.
They have history of a second malignant tumor (except for other skin cancers and in situ carcinoma of the cervix) within the past 5 years and uncertainty about the histologic nature of the metastatic lesions.
They are on corticosteroids or any other type of immunosuppressive agent (e.g., methotrexate, chloroquine, azathioprine, cyclophosphamide).
They are pregnant or breast feeding. Patients of childbearing potential must agree to use an effective method of contraception.
They have known hypersensitivity to any of the study drugs or to other selective 5-HT3(subscript).
They have ongoing emesis due to any organic etiology including but not limited to central nervous system or gastrointestinal metastasis.
They have grade 2 or higher nausea due to administration of drugs including but not limited to narcotics.
Intervention: Amiodarone
Trial phase: Phase 4
ATC code: C01BD01
SMILES: CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Intravenous amiodarone
Eligibility criteria:
Inclusion Criteria:

Males or females over the age of 40
Scheduled to undergo esophagectomy

Exclusion Criteria:

History of atrial fibrillation
Prior severe side effects from amiodarone
Elevated liver enzymes >3 times the upper limit of normal (UNL)
Corrected QT interval > 450 ms
Receiving class Ia or class III antiarrhythmics
Intervention: Loteprednol etabonate/tobramycin
Trial phase: Phase 4
SMILES: CCOC(=O)OC1(C(=O)OCCl)CCC2C3CCC4=CC(=O)C=CC4(C)C3C(O)CC21C.NCC1OC(OC2C(N)CC(N)C(OC3OC(CO)C(O)C(N)C3O)C2O)C(N)CC1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 72
Group description: 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
Eligibility criteria:
Inclusion Criteria:

Child, 0 to 6 years of age, any sex and race
Subject must have a clinical diagnosis of lid inflammation (e.g. Chalazion/Hordeolum) in at least one eye. If both eyes are diagnosed with lid inflammation, both eyes will be treated
In good health (no current or past relevant medical history), based on the judgment of the investigator
Parent/guardian is able and willing to follow instructions and provide informed consent

Exclusion Criteria:

Known hypersensitivity to corticosteroids, loteprednol etabonate, or any component of the study medication
Known hypersensitivity to aminoglycosides, tobramycin, or any component of the study medication
Use of concurrent ocular therapy with non-steroidal anti-inflammatory agent (NSAID), mast cell stabilizer, antihistamine, or decongestant within 48 hours before and during the study
Use of oral or topical ophthalmic corticosteroids (other than study medication) within 48 hours before and during the study
Use of systemic antibiotics within 72 hours before and during the 14 day study medication treatment duration
Use of topical ophthalmic antibiotics (other than the study medication) within 72 hours before and during the study
History of ocular surgery, including laser procedures, within the past six months
Anticipation that surgical intervention for lid inflammation will be required prior to completion of the study
Subjects with suspected vernal conjunctivitis, glaucoma of any kind, viral or bacterial conjunctivitis, preseptal cellulitis requiring systemic antibiotics, dacryocystitis, uveitis, or any other disease conditions that could interfere with the safety and efficacy evaluations of the study medication
History of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study
Participation in an ophthalmic drug or device research study within 30 days prior to entry in this study
Unlikely to comply with the protocol instructions for any reason
Intervention: Tadalafil
Trial phase: Phase 3
ATC code: C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51
SMILES: [H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 264
Group description: 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Male

History of erectile dysfunction (ED) for at least 3 months duration
Anticipate having the same female partner willing to participate throughout the study
At least 18 years of age at Visit 1 and agree to make at least 4 sexual attempts during the early phase of the study
Adequate partner sexual function as determined by a Female Sexual Function Index
Willing to record responses to efficacy questionnaires, sexual quality of life questionnaires and other instruments used in the study

Exclusion Criteria:

May not participate in the study if you have taken tadalafil previously.
History of cardiac conditions including angina requiring treatment with nitrates, heart disease of coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for specified time before starting the study.
Have sexual partner not willing to complete the scales.
Use of nitrates.
Intervention: Duloxetine Hydrochloride
Trial phase: Phase 4
SMILES: CNCCC(Oc1cccc2ccccc12)c1cccs1.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 151
Group description: Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
Eligibility criteria:
Inclusion Criteria:

Are outpatients, male or female, 30 through 75 years of age
Meet diagnostic criteria for major depression episode and a clinical diagnosis of idiopathic Parkinson's disease
Have a clinician-rated 17-item Hamilton Depression Rating Scale (HAMD17) total score greater than or equal to 15, a Beck Depression Inventory (BDI) total score greater than or equal to 13 and a Clinical Global Impression of Severity (CGI-S) score greater than or equal to 3 at both Visit 1 and Visit 2
Have satisfactory cognitive function
Have been held on stable dosage of antiparkinsonian medications for at least 4 weeks immediately prior to Visit 1

Exclusion Criteria:

Any current primary psychiatric diagnosis other than Major depressive episode, and any personality disorder that could interfere with the compliance with the study protocol
Atypical or secondary parkinsonism due to drugs or diseases with features of Parkinson's disease
Motor conditions for which it is to be expected to change the antiparkinsonian treatment during the course of the study
Clinically significant laboratory abnormalities or serious, unstable medical illness
Lack of response of current episode to two or more adequate courses of antidepressant therapy
Intervention: Capecitabine
Trial phase: Phase 2
ATC code: L01BC06
SMILES: CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 71
Group description: Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.

Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.
Eligibility criteria:
Inclusion Criteria:

Biopsy-diagnosed breast cancer with metastasis in multiple organs
Performance Status (World Health Organization :WHO) 0-2

Functions below are maintained in major organs:

Leukocyte count: 4,000/mm3 to 12,000/mm3
Neutrophil count: >2,000/mm3 or more
Platelet count: <100,000/mm3 or more
Hemoglobin: >9.5 g/dL
Total bilirubin: >1.5 mg/dL
AST(GOT): within twice a normal upper value in an institution
AST(GPT): within twice a normal upper value in an institution
BUN: < 25 mg/dL
Creatinine: within a normal upper value in the institution
24 hours creatinine clearance: >50 mL/min (using the Cockcroft-Gault formula)
Women's Ccr = Body weight x (140-Age)/(72 x Serum creatinine) x 0.85
Written informed consent will be obtained for patients for entering this study

Exclusion Criteria:

Patients with synchronous multiple cancers
Complicated with infection
Fever from suspected infection
Metastasis to the central nerve system
A history of ischemic cardiac diseases
Active gastrointestinal ulcer
Severe nerve disorder
Women who are potentially pregnant, pregnant, or breast-feeding
Severe drug allergy
Severe suppression of the bone marrow
Severe renal disorder
Being treated with other pyrimidine fluoride antineoplastic agents (including any combination therapy)
Being treated with flucytosine
Complicated with the infection onset which a study doctor assesses to be inappropriate for this study
Intervention: Finasteride
Trial phase: Phase 2
ATC code: D11AX10 | G04CA51 | G04CA55 | G04CB01 | G04CB51
SMILES: [H][C@@]12CC[C@@]3([H])NC(=O)C=C[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(=O)NC(C)(C)C)CC[C@@]21[H]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 204
Group description: Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
Eligibility criteria:
Criteria:

Histologically confirmed adenocarcinoma of the prostate
Clinical stage T1c or T2 (stage II)
Gleason score of 6 or 7 on initial biopsy
Prostate-specific antigen (PSA) level less than 10 ng/mL within the past 3 months
Candidate for and scheduled to undergo prostatectomy
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 70-100%
Fertile patients must use effective contraception
No active malignancy at any other site
No history of allergic reactions attributed to compounds of similar chemical or biological composition to finasteride
No uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection; Symptomatic congestive heart failure; Unstable angina pectoris; Cardiac arrhythmia
No psychiatric illness or social situation that would preclude study compliance
More than 6 months since prior hormonal agents, including dutasteride or finasteride
More than 6 months since prior chemotherapy
More than 1 month since prior participation in another investigational study
No prior radiotherapy for the primary tumor
No concurrent dehydroepiandrosterone, phytoestrogen supplements, antiandrogen therapy, dutasteride, or other finasteride
No concurrent anticoagulation, except for the use of daily acetylsalicylic acid (81 mg to 325 mg)
Intervention: Flibanserin
Trial phase: Phase 3
ATC code: G02CX02
SMILES: O=c1[nH]c2ccccc2n1CCN1CCN(c2cccc(C(F)(F)F)c2)CC1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 1723
Group description: Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
Eligibility criteria:
Inclusion Criteria:

Women with a primary diagnosis of HSDD who have completed a previous study of Flibanserin.
Patients must have used a medically acceptable method of contraception for at least 2 months before the start of the study and continue to use that method for the duration of the study.
Patients must be reliable, compliant, and agree to cooperate with all study evaluations.
Patients must be able and willing to give meaningful, written informed consent prior to the start of the study and be willing to discuss their sexual functioning with the study staff.

Exclusion Criteria:

A history of Major Depressive Disorder within 6 months prior to the start of the study, current suicidal thoughts, or any history of a suicide attempt.
Participation in another clinical trial within 1 month prior to the start of the study, except for Flibanserin.
Patients with pelvic inflammatory disease, urinary tract infection, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
Patients who are pregnant or have been pregnant within 1 month prior to study start.
Patients experiencing major life stress (including loss of income, death of a family member, major illness, etc.) or relationship trouble that could interfere with sexual activity, except distress about HSDD.
Clinically significant ECG or lab abnormalities at study start.
Patients taking prohibited medications that were excluded in their previous trial which contribute to sexual dysfunction or safety-related interactions.
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: 30
Group description: Montelukast 14 mg Intravenous Administration
Eligibility criteria:
Inclusion Criteria:

Adult participants with acute asthma attacks

Exclusion Criteria:

Participant has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., COPD, chronic heart failure, etc.).
Participant has a smoking habit (15 cigarettes per day) within a month prior to screening period, and/or has a smoking history (20 cigarettes per day) of more than 15 years.
Participant has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease.
Intervention: Montelukast Sodium
Trial phase: Phase 4
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: 100
Group description: Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Between 2 and 14 years old
Diagnosed with asthma, classified as mild persistent asthma according to Global Initiative Asthma Guidelines (GINA)
Diagnosed with comorbid allergic rhinitis

Exclusion Criteria:

Patients with suspected sinus infection
Prior treatment with high dose inhaled corticosteroid requiring a dose higher than beclomethasone dipropionate 400 ug per day, or equivalent, other medications used in severe cases
Intervention: Methotrexate
Trial phase: Phase 4
ATC code: L01BA01 | L04AX03
SMILES: CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 43
Group description: Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
Eligibility criteria:
Inclusion Criteria:

Diagnosis of active poly-JIA as determined by International League of Associations for Rheumatology (ILAR) criteria
Onset of signs and symptoms of poly-JIA for 12 months or less prior to study screening
Willing to use acceptable forms of contraception for the duration of the study and for 3 months after the study
Parent or guardian willing to provide informed consent
Able to attend all study visits

Exclusion Criteria:

Received or currently receiving disease-modifying antirheumatic drugs (DMARDs), biologic, or prednisone for any duration for treatment of poly-JIA, with the following exceptions:

Methotrexate duration must be less than or equal to 6 weeks at a dose of less than or equal to 0.5 mg/kg/week (40 mg max),
Steroid use has been less than or equal to 4 weeks and the subject is off of steroids for at least 1 week prior to enrollment
Received intramuscular or soft-tissue injections of corticosteroids for treatment of poly-JIA before receiving the first dose of study medication. Up to 2 joint injections with intra-articular steroids (IAS) will be allowed up to 7 days after the baseline visit.
History of or active cancer of any type
Active gastrointestinal disease (e.g., inflammatory bowel disease)
Chronic or acute kidney or liver disorder
Significant blood clotting defect
AST (SGOT), ALT (SGPT), or BUN levels more than two times the upper level of normal, creatinine levels more than 1.5 mg/dl, or any other laboratory abnormality considered to be clinically significant within 28 days prior to baseline
Chronic condition (e.g., diabetes, epilepsy) that is either not stable or poorly controlled and may interfere with study participation
Received any investigational medication within 30 days prior to the first dose of study medication or scheduled to receive an investigational drug (other than the study medications) during the course of the study
Chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 30 days prior to study screening
HIV infected
Known past or current hepatitis infection
Received a live virus vaccine within 1 month prior to baseline
Purified protein derivative (PPD) positive (positive tuberculosis [TB] test)
Pregnancy
Any medical condition that would make study participation difficult or inadvisable in the opinion of the investigator
History of or current psychiatric illness that would interfere with study participation
History of alcohol or drug abuse within the 6 months prior to study entry that would interfere with study participation
Inability to comply with study requirements for any reason