anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Chloroquine
Trial phase: Phase 3
ATC code: P01BA01 | P01BB52
SMILES: CCN(CC)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 160
Group description: Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
Eligibility criteria:
Inclusion Criteria:

Subjects aged greater than or equal to 6 months to 5 years presenting to Ndirande Health Centre with signs or symptoms consistent with malaria including, but not limited to, one or more of the following:

fever at the time of evaluation (axillary temperature greater than or equal to 37.5 degrees Celsius by digital thermometer)
report of fever within the last two days
clinically profound anemia (conjunctival or palmar pallor)
headache
body aches
abdominal pain
decreased intake of food or fluids
weakness
Weight greater than or equal to 5kg.
Positive malaria smear for P. falciparum mono-infection with parasite density 2,000-200,000/mm^3.
Planning to remain in the study area for 1 year.
Willingness to return for four-weekly routine visits, as well as unscheduled sick visits.
Parental/guardian consent for each participant.

Exclusion Criteria:

Signs of severe malaria: One or more of the following:

hemoglobin less than or equal to 5 g/dL
prostration
respiratory distress
bleeding
recent seizures, coma or obtundation (Blantyre coma score < 5)
inability to drink
persistent vomiting
Known allergy or history of adverse reaction to chloroquine (CQ), artesunate, azithromycin, erythromycin or atovaquone-proguanil (AP)
Chronic medication with any antibiotic or anti malarial medication
Previous enrollment in this study
Alanine aminotransferase (ALT) more than 5x the upper limit of normal or creatinine greater than 3x the upper limit of normal
Evidence of chronic disease or physical stigmata of severe malnutrition (i.e., loss of muscle mass or subcutaneous tissue, edema, or skin or hair findings consistent with severe malnutrition)
Intervention: Dorzolamide Hydrochloride
Trial phase: Phase 4
SMILES: CCNC1CC(C)S(=O)(=O)c2sc(S(N)(=O)=O)cc21.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Cosopt twice daily in both eyes
Eligibility criteria:
Inclusion Criteria:

bilateral open-angle glaucoma

Exclusion Criteria:

contraindications to Cosopt
pathology affecting tonometry
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: 23
Group description: erlotinib given before and after transurethral resection of a bladder tumor, TURBT

Erlotinib: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression

Radical Cystectomy: Will occur 4 weeks prior to dosing with erlotinib
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically confirmed muscle-invasive bladder cancer, meeting the following criteria:

Clinical stage T2 disease
No locally-extensive clinical stage T3 or T4 disease
No metastatic disease (N+, M+) by physical exam or radiologic evaluation
Must have undergone prior initial or confirmatory transurethral resection of the bladder tumor (TURBT)
Candidate for and has agreed to undergo radical cystectomy with curative intent
No non-transitional cell carcinoma histologies

PATIENT CHARACTERISTICS:

Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Granulocyte count > 1,500/mm³
Platelet count > 100,000/mm³
Bilirubin normal
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2 times upper limit of normal
Creatinine normal
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No contraindication to erlotinib hydrochloride or other tyrosine kinase inhibitors

PRIOR CONCURRENT THERAPY:

No prior radiotherapy or systemic chemotherapy for bladder cancer

Prior single-dose mitomycin C allowed at the time of TURBT
Prior 6- or 12-week course of adjuvant intravesical Bacillus Calmette-Guerin (BCG) therapy with or without recombinant interferon alfa-2a allowed
At least 4 weeks since other prior or concurrent radiotherapy, chemotherapy, or hormonal therapy
Intervention: Lubiprostone
Trial phase: Phase 3
ATC code: A06AX03
SMILES: [H][C@@]12CC(=O)[C@H](CCCCCCC(=O)O)[C@@]1([H])CC[C@](O)(C(F)(F)CCCC)O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 396
Group description: 8 mcg capsules twice daily (BID)
Eligibility criteria:
Inclusion Criteria:

18 years of age and older
Stable fiber therapy
Normal colonoscopy/sigmoidoscopy
Able to refrain from use of medications known to treat or associated with constipation symptoms
Experiences abdominal discomfort/pain associated with bowel movements
Reports decreased bowel movement frequency and/or other symptoms associated with constipation

Exclusion Criteria:

Diarrhea-predominant or alternating (diarrhea and constipation cycling) irritable bowel syndrome (IBS), or constipation other than that associated with IBS
Open gastrointestinal or abdominal surgery prior to IBS onset
Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, unexplained weight loss or rectal bleeding
Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests per investigator discretion
If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study
Intervention: Atomoxetine
Trial phase: Phase 4
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 48
Group description: atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
Eligibility criteria:
Inclusion Criteria (most important):

ASD (autistic disorder or Asperger's disorder or Pervasive Developmental Disorder - Not Otherwise Specified [PDD NOS])
Criteria A through D for Attention-Deficit/Hyperactivity Disorder (ADHD)
At least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the ADHD Rating Scale-IV-Parent Version
Intelligence quotient (IQ) score > 60

Exclusion Criteria (most important):

weight under 20 kg
Patients who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) criteria for ASD other than Autistic Disorder, PDD-NOS or Asperger's Disorder;history of Bipolar I or II disorder, schizophrenia, another psychotic disorder, substance abuse;Have a significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, or seizure disorder identified by history, physical examination, or laboratory tests; Patients who have taken (or are currently taking) anticonvulsants for seizure control.
patients at serious suicidal risk.
Contraindication to the use of atomoxetine
Patients who in the investigator's judgment are likely to need psychotropic medications apart from the drug. Patients who at any time during Study Period II are likely to begin a structured psychotherapy, likely to require hospitalization (i.e. in-patient treatment) or likely to be dismissed from in-patient treatment. Psychotherapy (including hospitalization) initiated at least 2 months prior to study participation is acceptable; however, after study participation has begun, only during Study Period III supportive or educational therapy is permitted.
Intervention: Acamprosate
Trial phase: Phase 4
ATC code: N07BB03
SMILES: CC(=O)NCCCS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
Eligibility criteria:
INCLUSION CRITERIA:

1. Men and women ages 21 to 65 years with a diagnosis of alcohol dependence.
2. History of at least 2 heavy drinking days (men > 5 drinks/day; women > 4 drinks/day) per week, on average, during the month prior to screening.
3. Ability to understand and sign written informed consent.
4. Willingness to refrain from drinking for at least three days prior to randomization.
5. Willingness to consider a goal of abstinence or a significant reduction in drinking as an objective.

EXCLUSION CRITERIA:

1. Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern.
2. Clinically significant psychiatric disease, e.g. bipolar disorder, psychosis, that might interfere with study participation or present a safety concern. [Subjects with depression or an anxiety disorder who are receiving medication and are clinically stable for at least one month will not be excluded.]
3. Suicidal ideation or behavior, history of suicide attempt.
4. Renal Impairment; estimated creatinine clearance <50 ml/min.
5. Substance use disorder other than alcohol or nicotine dependence or cannabis abuse.
6. Pregnant or breastfeeding women and women of childbearing potential who do not practice a medically acceptable form of birth control (oral or depot contraceptive, or barrier methods such as diaphragm or condom with spermicidal).
7. Individuals requiring inpatient treatment or more intense outpatient treatment for their alcohol dependence. Individuals may be considered for the trial upon completion of medical detoxification.
Intervention: Acamprosate
Trial phase: Phase 4
ATC code: N07BB03
SMILES: CC(=O)NCCCS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
Eligibility criteria:
INCLUSION CRITERIA:

1. Men and women ages 21 to 65 years with a diagnosis of alcohol dependence.
2. History of at least 2 heavy drinking days (men > 5 drinks/day; women > 4 drinks/day) per week, on average, during the month prior to screening.
3. Ability to understand and sign written informed consent.
4. Willingness to refrain from drinking for at least three days prior to randomization.
5. Willingness to consider a goal of abstinence or a significant reduction in drinking as an objective.

EXCLUSION CRITERIA:

1. Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern.
2. Clinically significant psychiatric disease, e.g. bipolar disorder, psychosis, that might interfere with study participation or present a safety concern. [Subjects with depression or an anxiety disorder who are receiving medication and are clinically stable for at least one month will not be excluded.]
3. Suicidal ideation or behavior, history of suicide attempt.
4. Renal Impairment; estimated creatinine clearance <50 ml/min.
5. Substance use disorder other than alcohol or nicotine dependence or cannabis abuse.
6. Pregnant or breastfeeding women and women of childbearing potential who do not practice a medically acceptable form of birth control (oral or depot contraceptive, or barrier methods such as diaphragm or condom with spermicidal).
7. Individuals requiring inpatient treatment or more intense outpatient treatment for their alcohol dependence. Individuals may be considered for the trial upon completion of medical detoxification.
Intervention: Donepezil
Trial phase: Phase 4
ATC code: N06DA02 | N06DA52 | N06DA53
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 199
Group description: Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
Eligibility criteria:
Inclusion criteria:

Age: 60 - 90 years old.
CDR: 0.5 - 2.0.
Patients who do not have severe depressive symptoms that affect cognition on depression scale of CERAD-K(C), GDS-K: 19 and below.
Modified Hachinski Ischemic Score (Rosen, et. al., 1979): 3 and below.
NINCDS-ADRDA criteria: Probable AD.

Exclusion criteria:

Patients who have delusions and other conscious dysfunction.
Patients who have neurologic diseases such as Parkinson's disease, stroke, tumor, normal pressure hydrocephalus, etc., on history and neurologic examination.
Patients who have history of infectious and inflammatory brain disease owing to virus, fungus and syphilis.
Patients with severe cerebrovascular pathology.
Patients who have present history of major psychological diseases such as depression and mania according to DSM-IV criteria.
Patients who have history of alcoholism or drug addiction.
Patients who have severe depressive symptoms that affect cognition on depression scale of CERAD-K.
Intervention: Tamsulosin
Trial phase: Phase 4
ATC code: G01AE10 | G04CA02 | G04CA52 | G04CA53 | G04CA54
SMILES: CCOc1ccccc1OCCN[C@H](C)Cc1ccc(OC)c(S(N)(=O)=O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 512
Group description: Tamsulosin 0.4mg po qd for 28 days
Eligibility criteria:
Inclusion Criteria:

Age ≥ 18 years
Evidence of ureterolithiasis (i.e. stone is located in ureter, not in bladder) as demonstrated on radiographic studies, specifically non-contrast spiral CT.
Willingness to participate and able to proceed with standard outpatient management (no personal or job-related issues, e.g. airline pilot.
Has a telephone in order to be contacted for follow-up.

Exclusion Criteria:

Patient desiring or requiring immediate surgical intervention making then not a candidate for outpatient kidney stone management.
Current urinary tract infection based on urine dipstick as admission and urgent procedural management are likely indicated.
Known anatomical genitourinary abnormalities or prior Genitourinary surgeries.
Positive pregnancy test making proper radiological imaging contraindicated.
Breastfeeding mothers.
History of hypersensitivity to tamsulosin.
Current use of alpha blockers or calcium channel blockers.
Current use of steroids which may have an independent effect on stone expulsion.
Spontaneous stone expulsion prior to enrollment.
Largest stone dimension ≥ 9mm assessed using radiologic imaging, being very unlikely to pass spontaneously.
Presence of stone in the bladder.
Current use of vardenafil which is tamsulosin contraindicated.
Ipsilateral, transplanted or solitary kidney as hospitalization may be necessary.
Known renal insufficiency.
Fever defined as >101.5°F which may indicate infection.
Floppy iris syndrome which is tamsulosin contraindicated.
Planned cataract surgery in the next 60 days which is tamsulosin contraindicated.
Prisoners /wards of state.
Prior enrollment in STONE (Candidates who are screened and found ineligible may be rescreened at a later date.)
Intervention: Eribulin
Trial phase: Phase 2
ATC code: L01XX41
SMILES: [H][C@@]12CC[C@]3([H])O[C@@]4([H])[C@H]5O[C@]6(CC[C@@]7([H])CC(=C)[C@]([H])(CC[C@@]8([H])C[C@@H](C)C(=C)[C@@]([H])(C[C@]9([H])O[C@H](C[C@H](O)CN)[C@H](OC)[C@@]9([H])CC(=O)C1)O8)O7)C[C@]5([H])O[C@@]4([H])[C@@]([H])(O6)[C@@]3([H])O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Patients receive E7389 IV on days 1 and 8.

eribulin mesylate: Given IV
Eligibility criteria:
Inclusion Criteria:

Histologically/cytologically confirmed pancreatic carcinoma (locally advanced, unresectable or metastatic)
measurable disease (at least 1 lesion accurately measured in at least 1 dimension (longest diameter as >20mm with conventional techniques or >10mm with spiral CT scan)
>=4 weeks from any major surgery
Up to 1 prior line of gemcitabine based systemic therapy (single agent/combination therapy) for locally advanced/metastatic disease with evidence of disease progression. Prior therapy with inhibitors of angiogenesis and/or the epidermal growth factor receptor permitted. Last chemotherapy dose >=4 weeks prior to randomization.
May have received prior 5FU (+/- folinic acid)/gemcitabine given concurrently with radiation as a "radiation sensitizer". Last chemotherapy dose >=4 weeks prior to randomization.
Prior radiation treatment >=4 weeks prior to randomization
Age >18 years.
Life expectancy >=3 months
ECOG< 2(Karnofsky-60%)
leukocytes>3,000/mcL
absolute neutrophil count>1,500/mcL
platelets>100,000/mcL
total bilirubin < 1.5 UNL
AST/ALT≤2.5x institutional ULN
creatinine within institution limits OR creatinine clearance>60mL/min/1.73m2 for patients with creatinine levels above institution limits
concurrent use of inhibitors/inducers of CYP3A4 are prohibited during the study treatment period
effects of E7389 on developing human fetus are unknown. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Ability to understand/willingness to sign written informed consent

Exclusion Criteria:

chemotherapy/radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
May not be receiving other investigational agents
Known brain metastases
History of allergic reactions attributed to compounds of similar chemical or biologic composition to E7389
Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study
Pregnant women excluded because E7389 is an antitubulin agent with the potential for teratogenic/abortifacient effects
HIV-positive patients on combination antiretroviral therapy are ineligible because of potential for p PK interactions with E7389
Other active malignancies in past 5 years except for cervical carcinoma in situ and non-melanomatous skin cancer
Intervention: Nicotine
Trial phase: Phase 4
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
Eligibility criteria:
Inclusion Criteria:

over 18
4 molars to be removed

Exclusion Criteria:

pregnant
lactating
chronic pain
narcotic use
asthma
ex-smokers
Intervention: Duloxetine
Trial phase: Phase 4
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 138
Group description: Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
Eligibility criteria:
Inclusion Criteria:

You must have been diagnosed with Diabetic Neuropathic Pain
Patient has an average daily pain score greater than or equal to 4 on an 11-point Likert scale, and patient or provider feel that a change from the current gabapentin therapy for pain management is warranted
Patient is currently treated with gabapentin greater than or equal to 900 milligram/day, has been prescribed the current dose for at least 4 weeks, and has been at least 80% compliant with dosing, according to patient report
Patient must agree not to change dose of gabapentin between Visits 1 and 2
You must have stable glycemic control

Exclusion Criteria:

Are judged prior to randomization to be at suicidal risk as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II)
Current diagnosis or history of hemangiosarcoma
Patients with New York Heart Association Class III or IV symptoms of congestive heart failure
Patients with uncontrolled narrow-angle glaucoma
Presence of a current seizure disorder
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: 22
Group description: Erlotinib 150 mg po daily.
Eligibility criteria:
Inclusion Criteria:

Biopsy proven stage I/II non-small cell lung cancer who are candidates for surgical resection
Ambulatory and capable of all self-care but may be unable to carry out any work activities.
Preoperative and postoperative high resolution CT scans done at NYPH-Weill Cornell medical center for purposes of volumetric measurements.
Acceptable cardiac, breathing, kidney, liver, and bone marrow functions.
18 years and older.
Women of child-bearing potential must be taking adequate contraceptive precautions prior to study entry and for the duration of study participation. A negative serum or urine pregnancy test is required within 7-10 days of Tarceva® administration. Men and premenopausal women of child bearing potential will follow an approved, medically accepted birth control regimen or agree to abstain from heterosexual intercourse while taking study drug and for 30 days following the last dose of study drug.

Exclusion Criteria:

Cannot be on any other anti-cancer treatment during this study.
Prior treatment with any EGFR inhibitor.
Patients who had prior treatment with chemotherapy or radiation for this disease.
Other active cancers.
Tumors with a mixed histology of small cell and non-small cell carcinoma as well as patients with pulmonary carcinoid tumors.
Gastro-intestinal abnormalities, including active peptic ulcer or inflammatory bowel disease.
Hypersensitivity to compounds similar in chemical composition to Tarceva®.
Active infection or serious underlying medical conditions which would impair protocol treatment.
Intervention: Zopiclone
Trial phase: Phase 4
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 194
Group description: Eszopiclone 2 mg tablets
Eligibility criteria:
Inclusion Criteria:

Male and female subjects with primary chronic insomnia. Subject is otherwise in good general health, based on screening physical examination and medical history.

Exclusion Criteria:

Subject has recent history of known clinically significant abnormal laboratory findings.
Intervention: RISEDRONIC ACID
Trial phase: Phase 3
ATC code: M05BA07 | M05BB02 | M05BB04 | M05BB07
SMILES: O=P(O)(O)C(O)(Cc1cccnc1)P(=O)(O)O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 110
Group description: 35 mg risedronate tablet, orally, once weekly on the same day
Eligibility criteria:
Inclusion Criteria:

cessation of menstruation (surgical or natural) between 6 and 36 months prior to study enrollment;
osteopenic
must have at least 1 evaluable radius and tibia, without history of fracture (traumatic or atraumatic)
BMI (body mass index) between 18 and 28 kg/m2 inclusive;

Exclusion Criteria:

history of any generalized bone disease, including hyperparathyroidism, Paget's disease of bone, renal osteodystrophy, or any other acquired or congenital bone disease; or any known condition that would interfere with the assessment of DXA (dual-energy X-ray absorptiometry) at either the lumbar spine (3 non-evaluable lumbar vertebrae at lumbar spine L1 - L4) or the femoral neck.
clinical or radiological evidence of osteoporosis, such as atraumatic vertebral compression fracture (* 20% reduction in anterior-to-posterior or middle-to-posterior height ratio; or 20% reduction of the anterior, middle, and/or posterior height as compared with the adjacent vertebrae) documented by spinal X ray or a history of osteoporosis-related atraumatic fracture of the hip or of the wrist;
glucocorticoid-induced osteopenia;
previous bisphosphonate therapy;