anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Diclofenac
Trial phase: Phase 2 | Phase 3
ATC code: D11AX18 | M01AB05 | M01AB55 | M02AA15 | S01BC03 | S01CC01
SMILES: O=C(O)Cc1ccccc1Nc1c(Cl)cccc1Cl
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
Eligibility criteria:
Inclusion criteria

Noncyclic mastalgia or surgical scar-related pain occurring at least 2 days per week and for which the patient desires treatment
Duration of pain > 2 months (noncyclic mastalgia) or > 4 months (surgical scar-related pain)
Age > 18 years
Satisfactory breast examination and directed ultrasound at site of pain (all ages) within 12 months
Satisfactory mammogram (all women > 30 years of age) within 12 months
Negative pregnancy test (all women who are premenopausal and have not had hysterectomy or tubal ligation)

Exclusion criteria

Cyclic mastalgia (as defined above)
Duration of pain > 2 months (noncyclic mastalgia) or > 4 months (surgical scar-related pain)
Abnormal breast examination or imaging (abnormality at the site of pain or for which biopsy or surgical consultation is recommended)
Known pregnancy, lactation, positive pregnancy test, or anticipated pregnancy within 6 months
Asthma, that has been aggravated by oral nonsteroidal antiinflammatory agents
Allergy, to diclofenac or any nonsteroidal antiinflammatory agents
Rash or open lesions at the site on the breast where the topical agent would be applied
Incomplete or abnormal healing (surgical scar-related pain)
History of gastrointestinal ulceration, renal dysfunction (creatinine > 1.5), hepatic disease (known liver disease or aspartate aminotransferase (AST) twice normal levels), congestive heart failure and uncontrolled hypertension (blood pressure > 140/90)
Intervention: Innohep
Trial phase: Phase 4
SMILES: [Sn+4]
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 270
Group description: innohep® 175 anti-Xa IU/kg once daily
Eligibility criteria:
Inclusion Criteria:

Patients with a symptomatic and objectively confirmed Venous Thromboembolism (VTE) (lower limb deep venous thrombosis (DVT) or pulmonary embolus (PE)) with mandatory presences of objectively confirmed and treatment requiring DVT, i.e. symptomatic and objectively confirmed distal DVT or objectively confirmed, symptomatic or asymptomatic proximal DVT (confirmation of DVT should be performed by ultrasonography or venography within 48 hous prior to randomisation)
Patients with an indication for DVT treatment with SC Low Molecular Weight Heparin (LMWH) or Unfractionated Heparin (UFH) followed by Oral Anticoagulant (OAC) for at least 90 days
Hospitalized patients who, during SC anticoagulant treatment, will be followed, as specified in the protocol, on a daily basis either in the hospital or in an out-patient setting
Patients at or above 75 years with a creatinine clearance less than or equal to 60 mL/min calculated according to the Cockcroft-Gault formula
Patients at or above 70 years with a creatinine clearance less than or equal to 30 mL/min calculated according to the Cockcroft-Gault formula

Exclusion Criteria:

Patients receiving high dose (i.e. equivalent to a dose recommended for treatment of DVT) of UFH or LMWH or thrombolytic agents within the last 4 weeks except for UFH/LMWH during the last 36 hours prior to randomisation
Patients on oral anticoagulant treatment (vitamin K-antagonists) at or within last 1 week prior to randomisation
Patients with a symptomatic venous thromboembolism (VTE) requiring thrombolytic therapy or invasive intervention
End stage renal disease patients requiring dialysis
Surgery within 2 weeks prior to randomisation or planned surgery, epidural anaesthesia and/or spinal anaesthesia during the SC anticoagulant treatment period
Planned use of acetylsalicylic acid in doses above 300 mg/day, NSAID or Dextran 40 at randomisation and during the SC anticoagulant treatment period
Patients with a current overt bleeding or known haemorrhage condition (e.g. active G.I. ulcer)
Patients with a platelet count < 100 x 10 9/L
Patients with a known history of heparin-induced thrombocytopenia
Patients with known severe hepatic insufficiency manifested as international normalized ratio (INR) greater than or equal to 1.5
Patients with uncontrolled severe hypertension i.e. a systolic blood pressure > 220 mm Hg or diastolic blood pressure > 120 mm Hg during at least 2 measurements within 24 hours prior to randomisation
Patients with ischaemic stroke at or within last 1 week prior to randomisation
Patients with a known haemorrhagic stroke within 3 months prior to randomisation
Patients with known bacterial endocarditis within 3 months prior to randomisation
Intervention: Vorinostat
Trial phase: Phase 2
ATC code: L01XH01
SMILES: O=C(CCCCCCC(=O)Nc1ccccc1)NO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: The dose of vorinostat was 300 mg two times a day on the first 3 days of every week on a 4-week cycle.
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of advanced renal cell carcinoma that is either metastatic or inoperable
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Disease is recurrent or refractory to interleukin-2 (IL-2) or interferon-based therapy OR new diagnosis in previously untreated patients who are not appropriate candidates to receive IL-2 based treatment
Patients who have failed up to 4 lines of prior immunotherapy or biological therapy allowed
No known brain metastases or leptomeningeal disease
Stable brain metastases or curatively resected brain metastases without neurologic dysfunction for ≥ 6 months allowed
ECOG performance status 0-2 OR Karnofsky 70-100%
Life expectancy ≥ 12 weeks
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 9.0 g/dL
Serum creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance > 50 mL/min
Total bilirubin within normal limits
AST/ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver metastasis is present)
No history of active malignancy (other than renal cell carcinoma) within the past 3 years other than nonmelanomatous skin cancer, in situ breast cancer, or in situ cervical cancer
No history of allergic reactions to compounds of similar chemical or biological composition to vorinostat (SAHA)
No uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
No psychiatric illness or social situation that would preclude study compliance
No clinically significant hypercalcemia
No significant traumatic injury within the past 21 days
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No gastrointestinal disease resulting in an inability to take oral medication
No requirement for IV alimentation
No active peptic ulcer disease
Recovered from prior therapy
Prior nephrectomy or resection of metastatic lesions allowed provided full surgical recovery has occurred
No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin)
No radiotherapy within the past 4 weeks
No valproic acid for at least 2 weeks prior to study enrollment
No prior surgical procedures affecting absorption
No major surgery within the past 21 days
No concurrent antiretroviral therapy for HIV-positive patients
No other concurrent investigational agents
No other concurrent anticancer therapy
Intervention: Imatinib Mesylate
Trial phase: Phase 2
SMILES: CS(=O)(=O)O.Cc1ccc(NC(=O)c2ccc(CN3CCN(C)CC3)cc2)cc1Nc1nccc(-c2cccnc2)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: patients receiving adjuvant imatinib mesylate

Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks
Eligibility criteria:
Inclusion Criteria:

Histologically proven diagnosis of GIST, with positive immunostaining for KIT (CD117)
Tumor size > 5 cm and mitotic rate > 5/50HPF(High Power Field), or tumor size > 10 cm irrespective of mitotic rate, or mitotic rate > 10/50 HPF irrespective of tumor size.
Presence of mutation in exon 11 of c-kit gene.
Surgery performed from 3 weeks to 8 weeks before administration of Imatinib mesylate.
No evidence of residual macroscopic and microscopic disease after surgery.
Absence of distant metastases
No prior radiation therapy, no prior chemotherapy, no prior therapy with Imatinib mesylate, or any other molecular targeted or biological therapy.
Age 18 yrs or older
ECOG(Eastern Cooperative Oncology Group electrocorticogram) performance status = 0-2
No New York Heart Association (NYHA) Class 3~4 cardiac problems
Absence of severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal disease, uncontrolled liver disease, including chronic viral hepatitis judged at risk of reactivation, uncontrolled active infection, such as human immunodeficiency virus (HIV) infection, etc.).
No ongoing pregnancy or nursing..
No prior, or ongoing other malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or adequately treated cancer with eradicative intent for which the patient has been continuously disease-free for 5 years.
No use of coumarin derivatives at the time of treatment start.
Adequate liver function, as defined by a serum bilirubin < 1.5 x the institutional upper limit of normal (IULN), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 IULN, obtained within 7 days prior to randomization.
Adequate renal function, as defined by a serum creatinine < 1.5 x IULN, obtained within 7 days prior to randomization.
Absolute neutrophil count (ANC) > 1.5 x 109/l and a platelet count > 100 x 109/l obtained within 7 days prior to randomization. Baseline hemoglobin > 9 g/dl (this may be achieved by transfusions if needed).
Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Intervention: Aripiprazole
Trial phase: Phase 2
ATC code: N05AX12
SMILES: O=C1CCc2ccc(OCCCCN3CCN(c4cccc(Cl)c4Cl)CC3)cc2N1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 10
Group description: This treatment arm (also called the "combination arm") consists of parent training plus continued treatment on a stimulant (that is tolerated but has not yet decreased ADHD symptoms enough to meet our criterion of response), plus augmentation with aripiprazole. Aripiprazole pills are taken once daily over a period of 8 weeks, with patients evaluated on a weekly basis. Dosing will start at 2.5 mg and will be titrated up to 5 mg by week 1, and up to 10 mg by week 2 and for the remainder of the trial.

aripiprazole: double blind capsules (abilify or placebo) taken once daily, up to 10mg.
Eligibility criteria:
Inclusion Criteria:

English or Spanish speaking parent/guardian. Parent/guardian and child must be able to understand the protocol.
Primary diagnosis of ADHD despite treatment with a stimulant by the primary care treatment provider.
Non-responder or partial responder to stimulant treatment. ADHD symptoms and clinical impairment despite treatment with stimulant (including OROS-MPH [Concerta] or mixed salts amphetamine [Adderall]).
IQ of greater than 70.
The subject must be in school.
The family must be able to attend weekly visits.

Exclusion Criteria:

Unable to understand protocol or follow study procedures.
Subject doing well on stimulants.
Subjects showing lack of response or minimal response to stimulants due to non-compliance with taking medication or taking suboptimal doses.
Autism, Psychosis, Bipolar Disorder, Drug Abuse, significant suicidality, or any other psychiatric disorder (such as MDD, Anxiety Disorders, Eating Disorders) in addition to ADHD that will require treatment with additional medication or therapy.
The subject is using or abusing recreational drugs or has a positive urine toxicology screen (except for stimulants).
The subject has a history of physical, sexual, or emotional abuse that resulted in a clinically significant impact on clinical presentation, potentially driving some of the symptoms of ADHD.
Females who are pregnant or breast-feeding or who have a positive urine pregnancy test.
Sexually active females and males who do not agree to use adequate birth control.
Abnormal cardiac function.
Subject is taking prohibited concomitant medication during phase 1 or phase 2 of the trial.
Intervention: Kenalog
Trial phase: Phase 3
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 91
Group description: Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.

Subjects younger than 12 years old received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration.
Eligibility criteria:
Inclusion Criteria:

Male or female, age 0-18 years
Patients with serous otitis media and/or negative middle ear pressure as documented by otoscopic examination and tympanometry will be considered for enrollment
Pregnant

Exclusion Criteria:

Unwilling to discontinue breast feeding, when applicable
Active upper respiratory infection
Nasopharyngeal mass
Chronic infectious otitis media
Cholesteatoma
Acute infectious otitis media
History of otologic surgery other than placement of a pressure equalizer tube in the affected ear
History of radiation therapy to the head and neck region
Neuromuscular disease
Cystic fibrosis
Immunodeficiency
Mucociliary disorders
Craniofacial disorders/syndromes
Cleft palate
Development delay and/or symptoms suggestive of perilymph fistula
Intervention: Lamotrigine
Trial phase: Phase 4
ATC code: N03AX09
SMILES: Nc1nnc(-c2cccc(Cl)c2Cl)c(N)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of bipolar I, II, not otherwise specified or cyclothymic disorders
Currently depressed or mixed mood state
Ages 18-70 years
Men or women
Self-reported cocaine use within 14 days prior to randomization
English or Spanish speaking
Baseline Hamilton Depression Rating Scale (HRSD17) score ≥ 10

Exclusion Criteria:

Currently taking an enzyme inducing or inhibiting anticonvulsant (e.g. valproic acid, carbamazepine)
Current severe psychotic features (e.g. daily auditory hallucinations, fixed delusions, severely disorganized thought processes) that require antipsychotic therapy, and that do not appear to be secondary to cocaine use
Active suicidal ideation (plan and intent) or ≥2 attempts in past 12 months or any attempt in the past month
Highly unstable medical condition
Change in concomitant psychiatric medications (e.g. initiated antipsychotic) or in other substance abuse treatment (e.g. began intensive outpatient treatment) within 7 days prior to study entry
Vulnerable populations (e.g. pregnant or nursing women, prisoners, mentally retarded)
Intervention: Ziprasidone
Trial phase: Phase 3
ATC code: N05AE04
SMILES: O=C1Cc2cc(CCN3CCN(c4nsc5ccccc45)CC3)c(Cl)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 127
Group description: Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.
Eligibility criteria:
Inclusion Criteria:

Adults meeting DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for Bipolar I Disorder (currently with manic or mixed symptoms)

Exclusion Criteria:

Ultra rapid cyclers and subjects with significant cardiovascular disease including history of QT prolongation and/or congenital long QT syndrome
Intervention: Arginine
Trial phase: Phase 2
ATC code: B05XB01 | V03AF11
SMILES: N=C(N)NCCC[C@H](N)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: L-arginine 1 g tablets were made by Jarrow Formulas.
Eligibility criteria:
Inclusion Criteria:

Moderate to severe persistent asthma
Subject is stable on same asthma medications for at least one month
If the subject is a woman of child-bearing age, a negative pregnancy test

Exclusion Criteria:

Less than 18 yrs/ age
Baseline Forced Expiratory Volume in 1 second (FEV1) <40% predicted
Known or suspected allergy to L-arginine
Pregnant women, nursing women, or women actively trying to achieve pregnancy
Current smokers
Subjects with more than a 15 pack-year history of smoking
Intervention: Erlotinib
Trial phase: Phase 2
ATC code: L01EB02 | L01XE03
SMILES: C#Cc1cccc(Nc2ncnc3cc(OCCOC)c(OCCOC)cc23)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Erlotinib plus Digoxin

Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression.
Eligibility criteria:
Inclusion Criteria:

diagnosis of non-small cell lung cancer
measurable or evaluable disease
primary tumor must be documented by histopathic analysis
disease recurrences occurring greater than five years after original diagnosis must be biopsy proven
treatment with only one prior chemotherapy regimen for advanced disease (one additional prior regimen was allowed for neoadjuvant, adjuvant, or neoadjuvant plus adjuvant therapy)
serum creatinine < 2mg/dl, or a calculated creatinine clearance > 40cc/min using the following formula: (140-age) x WT(kg) x 0.85 (if female 0.72) x creatinine (mg/dl). Tests must be done within 28 days prior to registration
must have a CT scan (chest & abdomen) within 4 weeks prior to registration
Zubrod performance status of 0-3

Exclusion Criteria:

women who are pregnant or nursing
no other prior malignancy is allowed except for: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
history of ventricular fibrillation, sinus node or AV nodal disease, Wolff Parkinson White Syndrome, evidence of congestive heart failure, chest pain with exertion, hemodynamically significant or life threatening cardiac arrhythmia, or evidence of prior myocardial infarction on EKG. EKG must have been done within 28 days prior to registration. A normal cardiac stress test within 182 days prior to registration is required for all patients over 50 years old or those with abnormal EKG or any history of cardiac disease.
hypersensitivity to erlotinib and/or Digoxin
abnormal levels of K, Mg, and/or Ca, or conditions which cause such abnormalities (e.g. malnutrition, severe diarrhea, prolonged vomiting, dialysis, GI suction, untreated hypothyroidism, and use of diuretics, amphotericin B, steroids, or antacids)
Intervention: Nesiritide
Trial phase: Phase 1 | Phase 2
ATC code: C01DX19
SMILES: CCC(C)C1NC(=O)C(CCCNC(=N)N)NC(=O)C(CC(=O)O)NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C(CCCNC(=N)N)NC(=O)CNC(=O)C(Cc2ccccc2)NC(=O)C(NC(=O)CNC(=O)C(CO)NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C2CCCN2C(=O)C(N)CO)C(C)C)CSSCC(C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CC(C)C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc2c[nH]cn2)C(=O)O)C(C)C)NC(=O)CNC(=O)C(CC(C)C)NC(=O)CNC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CO)NC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 9
Group description: Patients received nesiritide 0.015 mcg/kg/hour for 10 hours
Eligibility criteria:
Inclusion Criteria:

> 48 hours after cardiac surgery requiring cardiopulmonary bypass
< 1 year of age
Receiving chlorothiazide and furosemide for > 12 hours
Urine output < 4 cc/kg/hour, or fluid intake > output for 2 consecutive days
Receiving mechanical ventilation
Presence of body wall edema on CXR, defined as a radiologic index of > 2
Plan for > 24 hrs further diuresis before chest closure or extubation

Exclusion Criteria:

Age > 365 days at the time of enrollment
Corrected estimated gestational age < 35 weeks at the time of enrollment
Serum creatinine > 2.0 mg/dL at the time of enrollment
Significant hemodynamic instability at the time of enrollment
Lack of dedicated intravenous access for nesiritide infusion
Lack of arterial line for continuous blood pressure monitoring
Lack of a Foley catheter for continuous urine collection
Enrollment in another research study such that the outcomes of either study may be confounded by participation in this study, or such that the amount of blood drawn for research purposes becomes excessive.
Intervention: Betaine
Trial phase: Phase 2
ATC code: A09AB02 | A16AA06
SMILES: C[N+](C)(C)CC(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Subjects received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old), divided in two doses daily, for 2 months.
Eligibility criteria:
Inclusion Criteria:

A definitive diagnosis of Type 1 Primary Hyperoxaluria (PHI) as confirmed by hepatic angiotensinogen (AGT) deficiency, biochemical criteria (marked hyperoxaluria and hyperglycolic aciduria) or mutation analysis (having a known PHI mutation)
Alanine-glyoxylate aminotransferase (AGXT) genotype known
Hyperoxaluria not fully corrected by 3 months of continuous Vitamin B6 (VB6) at doses of 8 mg/kg/d or more
Males or females, 6-70 years of age, inclusive
Preserved renal function, as defined by measured glomerular filtration rate (GFR) > 30 ml/min/1.73 m^2
Sexually active female patients of childbearing potential must practice adequate contraception during the treatment period and for 6 months after discontinuation of therapy. A pregnancy test obtained at entry prior to the initiation of treatment must be negative. Female patients must not be breast-feeding. Sexually active male patients must practice acceptable methods of contraception during the treatment period and for 6 months after discontinuation of therapy.
Written informed consent for participation in this study.

Exclusion Criteria:

Patients who are fully VB6 responsive (i.e., G170R homozygotes).
Prior recipients of liver transplantation performed for correction of AGT deficiency.
Pregnancy or breastfeeding
Unwillingness of patient and/or partner to use contraception during treatment.
Malignant disease (other than non-melanoma skin cancer) in the previous two years.
Markedly reduced renal function (Stage IV Chronic Kidney Disease or measured or estimated GFR < 30 ml/min/1.73 m^2)
Allergy to betaine or related compounds
History of papilledema or increased intracranial pressure.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
Eligibility criteria:
Inclusion Criteria:

Lower urinary tract symptoms due to benign prostatic hyperplasia
Enlarged prostate volume by rectal ultrasound

Exclusion Criteria:

Previous prostate surgery
Previous or current diagnosis of prostate cancer
Use of other medications for the treatment of prostatic hyperplasia
Urinary tract infection