anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
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: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast

Evidence of metastatic involvement (stage IV disease)

Patients must have measurable disease

At least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
Treated brain metastases (surgery or radiation therapy) allowed if clinically stable
Patients with leptomeningeal disease are ineligible

Hormone receptor status:

Not specified

PATIENT CHARACTERISTICS:

Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Male or female
Menopausal status not specified
Absolute neutrophil count (ANC) ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Creatinine clearance > 50 mL/min
Fertile patients must use effective contraception
No history of another severe and/or life-threatening medical disease
No other active primary malignancy
Not pregnant or nursing
Negative pregnancy test
Patients with asymptomatic HIV infection are eligible
Liver dysfunction score ≤ 9
No pre-existing liver disease (i.e., cirrhosis or active viral hepatitis)
No active gastrointestinal malabsorption illness

No clinically significant cardiac disease, including the following:

Congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication, or myocardial infarction within the past six months
No prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to fluorouracil, or known dihydropyrimidine dehydrogenase deficiency
No history of uncontrolled seizures or central nervous system disorders
No significant history of noncompliance to medical regimens
No clinically significant psychiatric disability that would preclude study compliance

PRIOR CONCURRENT THERAPY:

No previous capecitabine

Up to 3 prior cytotoxic regimens allowed for metastatic disease

Prior noncytotoxic therapy allowed (e.g., hormonal treatment or trastuzumab)
No other concurrent therapies intended to treat the primary condition including chemotherapy, biologic agents, or immunotherapy
No concurrent anti-estrogen therapy, radiation therapy, or investigational systemic therapy
No other concurrent investigational drugs

No concurrent use of the following drugs: warfarin for full anticoagulation, cimetidine, or azidothymidine (AZT)

Mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed
At least 4 weeks since prior sorivudine or brivudine
Concurrent use of bisphosphonates allowed if initiated before beginning study therapy
Concurrent use of megestrol acetate suspension as an appetite stimulant allowed
Intervention: Bortezomib
Trial phase: Phase 2
ATC code: L01XG01 | L01XX32
SMILES: CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
Eligibility criteria:
Inclusion Criteria:

Histologically confirmed pure non-clear cell renal cell carcinoma (RCC)
Distant metastatic disease (Tx, Nx, M1)
Tumor expresses wild-type von Hippel-Lindau tumor suppressor gene/protein
Measurable disease on imaging scan (≥ 1 cm)
Brain metastases allowed provided they have been treated with surgery and/or radiation therapy and show no evidence of progression on cerebral CT or MRI scan 2 months following surgery and/or radiation therapy.
Life expectancy ≥ 3 months
Karnofsky performance status ≥ 60%
Negative pregnancy test
Fertile patients must use an acceptable method of contraception
No other major illnesses likely to limit survival
Platelet count ≥ 100,000/mm^3
Absolute neutrophil count ≥ 1, 000/mm^3
Hemoglobin ≥ 10 g/dL (transfusion allowed)
Creatinine clearance ≥ 30 mL/min OR creatinine ≤ 2 mg/dL
ALT or AST ≤ 2.5 times upper limit of normal
At least 4 weeks since prior radiotherapy and recovered
More than 30 days since any other prior investigational drugs

Exclusion Criteria:

active CNS metastases
pregnant or nursing
myocardial infarction within the past 6 months
New York Heart Association class III or IV heart failure
uncontrolled angina
severe uncontrolled ventricular arrhythmias
electrocardiographic evidence of acute ischemia or active conduction system abnormalities
Peripheral neuropathy ≤ grade 1
hypersensitivity to bortezomib, boron, or mannitol
history of a non-RCC malignancy within the past 5 years except basal cell carcinoma of the skin
serious medical or psychiatric illness that would preclude study participation
prior cytotoxic chemotherapy for this cancer
other concurrent investigational therapy
concurrent chemotherapy, immunotherapy, or hormonal therapy
Intervention: PIDOLIC ACID
Trial phase: Phase 2 | Phase 3
ATC code: A12CC08
SMILES: O=C1CC[C@@H](C(=O)O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 159
Group description: PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted
Eligibility criteria:
Inclusion Criteria:

Adults undergoing intracranial surgery

Exclusion Criteria:

Patient refusal
Pregnancy
Aphasia
Respiratory failure
Allergy/intolerance to fentanyl
Opioids use
History of opioid-dependent pain,
Patient has been in an investigational drug trial (except chemotherapy) in the month preceding the day of enrollment
Mental or physical limitations that would prevent patient assessment or PCA use
Chronic painful conditions unrelated to the reason for surgery,
Clinically significant respiratory disease that required supplemental oxygen or ventilatory support such as use of mechanical ventilation or positive pressure ventilation
Patient is unable to initiate a bolus dose of IVPCA fentanyl
Intervention: Fluoxetine
Trial phase: Phase 4
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: Female
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 49
Group description: fluoxetine up to 80 mg per day

Fluoxetine
Eligibility criteria:
Inclusion Criteria:

Meets DSM-IV criteria for anorexia nervosa (except the requirement for amenorrhea)
Successfully completed treatment at one of the study sites in an inpatient or day-program setting immediately prior to study entry (BMI remained at least 19 kg/m2 for two weeks)

Exclusion Criteria:

Currently taking any medications other than occasional lorazepam or zopiclone for anxiety or sleep disturbance
Previous serious adverse reactions to fluoxetine (e.g., allergy)
Currently at risk for suicide
Any medical condition requiring treatment with other psychotropic medication (except the occasional use of anti-anxiety medication)
Pregnant
Any serious medical illness besides the eating disorder
History of continuous illness (at a low weight with no periods of remission or return to normal functioning for more than 15 years)
Intervention: Fingolimod
Trial phase: Phase 3
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 429
Group description: Patients self-administered fingolimod 1.25 mg capsules orally once daily.
Eligibility criteria:
Inclusion Criteria:

Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
Patients with a relapsing-remitting disease course
Patients with EDSS score of 0-5.5

Exclusion Criteria:

Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria applied to this study.
Intervention: Fingolimod
Trial phase: Phase 3
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 425
Group description: Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Eligibility criteria:
Inclusion Criteria:

Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
Patients with a relapsing-remitting disease course
Patients with EDSS score of 0-5.5

Exclusion Criteria:

Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria applied to this study.
Intervention: Haloperidol
Trial phase: Phase 3
ATC code: N05AD01
SMILES: O=C(CCCN1CCC(O)(c2ccc(Cl)cc2)CC1)c1ccc(F)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Once delirium was diagnosed, subjects were randomized to haloperidol 5 mg IV q 12h, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.
Eligibility criteria:
Inclusion Criteria:

All adult (>=18 years of age) mechanically ventilated patients admitted to the medical, surgical, trauma, or cardiothoracic ICUs of the UPMC main campus who are expected by the ICU clinical team to require >24 hours of mechanical ventilation

Exclusion Criteria:

Baseline QTc >480 milliseconds (ms); history of Parkinson's disease; pregnancy; history of schizophrenia or neurologic disease that would confound the delirium assessment; deafness or inability to understand English or Spanish; extubation prior to enrollment; previously enrolled in this study; patient, family, or attending physician refusal; death before enrollment; treatment with haloperidol within 2 days prior to ICU admission; and prisoners.
Intervention: Amiodarone
Trial phase: Phase 3
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: 19
Group description: Perioperative amiodarone

Amiodarone: Perioperative orally administered

Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery
Eligibility criteria:
Inclusion Criteria:

Resectable lung nodule or mass

Exclusion Criteria:

Allergy to amiodarone
Currently taking amiodarone
Documented atrial fibrillation within past 12 months
Known pulmonary fibrosis
Known hepatic dysfunction
Thyroid disease
2nd or 3rd degree heart block
Severe SA node disease
Bradycardia-induced syncope
Pregnancy
Intervention: Crisaborole
Trial phase: Phase 1
ATC code: D11AH06
SMILES: N#Cc1ccc(Oc2ccc3c(c2)COB3O)cc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.
Eligibility criteria:
Inclusion Criteria for Liver Recipients:

Received liver from living parent donor
Received transplant at least 4 years prior to study entry
Less than 18 years of age at time of transplant
Parent or guardian willing to provide informed consent

Inclusion Criteria for Liver Donors:

Willing to participate in this study

Exclusion Criteria for Liver Recipients:

Underwent transplant because of liver failure related to autoimmune disease
Underwent transplant of a second organ simultaneously with or after liver transplant OR liver retransplantation
Receiving immunosuppression with more than one drug
50% increase in dose of current immunosuppressive drug
HIV infection
Hepatitis B or C virus infection
Pregnancy or breastfeeding
Intervention: Goserelin Acetate
Trial phase: Phase 2
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: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
Eligibility criteria:
Inclusion Criteria:

Pre-menopausal women aged 18 years or over with histologically/cytologically-confirmed oestrogen receptor positive (ER +ve) breast cancer
World Health Organization (WHO) performance status of 0, 1, or 2
Provided written informed consent

Exclusion Criteria:

Treatment with tamoxifen or other hormonal therapies as early breast cancer (EBC) adjuvant in the previous 24 weeks
Received radiotherapy within the past 4 weeks
History of systemic malignancy other than breast cancer within the previous 3 years
Estimated survival less than 24 weeks
Intervention: Goserelin Acetate
Trial phase: Phase 2
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: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
Eligibility criteria:
Inclusion Criteria:

Pre-menopausal women aged 18 years or over with histologically/cytologically-confirmed oestrogen receptor positive (ER +ve) breast cancer
World Health Organization (WHO) performance status of 0, 1, or 2
Provided written informed consent

Exclusion Criteria:

Treatment with tamoxifen or other hormonal therapies as early breast cancer (EBC) adjuvant in the previous 24 weeks
Received radiotherapy within the past 4 weeks
History of systemic malignancy other than breast cancer within the previous 3 years
Estimated survival less than 24 weeks
Intervention: Acetaminophen
Trial phase: Phase 3
ATC code: N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71
SMILES: CC(=O)Nc1ccc(O)cc1
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 374
Group description: Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child's weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination. Study drug was formulated to provide 160 mg of acetaminophen per 5 cc dose.
Eligibility criteria:
Inclusion Criteria:

Child is a current Group Health enrollee.
Child will be seen at a Group Health clinic for a Well Child visit that is expected to include 2 or more vaccines after 6 wks and before 10 months of age.

Exclusion Criteria:

If child was born at less than 36 weeks of gestation, the child is not eligible until 4 months of age or older.
If the child's birth weight was less than 5.5 pounds (2500 grams), the child is not eligible until 4 months of age or older.
Intervention: Topiramate
Trial phase: Phase 4
ATC code: A08AA51 | N03AX11
SMILES: [H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
Eligibility criteria:
Inclusion Criteria:

DSM-IV Diagnosis of Alcohol Dependence; Minimal drinking level of 14 drinks per week for women and 20 drinks per week for men over a consecutive 30 day period during the last 90 days
Intent to stop drinking
Male or female age 18-65
Able to maintain sobriety for 3 consecutive days without the use of detoxification medications
Able to provide informed consent and to comprehend study procedures.
If a woman, then is willing to use an effective means of birth control during throughout the study period. These include: a. barrier (diaphragm or condom) with spermicide b.intrauterine progesterone contraceptive system c. levonorgestrel implant d. medroxyprogesterone acetate contraceptive injection e. complete abstinence

Exclusion Criteria:

Dependent on or extensive abuse of drugs or substances other than ethanol, nicotine, or caffeine as assessed by urine toxicology (2 out of 3 Dependent on or extensive abuse of drugs or substances other than positive consecutive urines)
DSM IV Axis I diagnoses other than ethanol, caffeine, or nicotine dependence severe enough to require treatment with medication or to prevent compliance with the protocol.
Currently being treated with disulfiram (Antabuse), naltrexone (ReVia), or acamprosate
Currently being treated with any other psychoactive or other CNS medications or a carbonic anhydrase inhibitor (e.g. acetazolamide)
In need of medical detoxification from alcohol.
Prior history of kidney stones.
History of liver disease. ALT or AST 3 times higher than upper range of normal values.
BUN or serum creatinine outside the normal range
Major neurological disorder including seizures
Other major diseases including severe hypertension, renal disease, or cardiac disease.
Prior participation within 60 days in another clinical study.
If female, a positive serum HCG or breast feeding.
If female using oral contraceptives as a means of birth control.
History of allergic sensitivity to topiramate
Pending imprisonment
Cardiac pacemaker or metal surgical implant.
History of angle closure glaucoma.
Intervention: Topiramate
Trial phase: Phase 2
ATC code: A08AA51 | N03AX11
SMILES: [H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.

Topiramate
Eligibility criteria:
Inclusion Criteria:

Treatment seeking individuals as the time of the study
Must be able to proved written informed consent
Must have a body mass index greater than 18 kg/m(2)
Must meet DSM-IV criteria for methamphetamine dependence
Must currently be using methamphetamine as confirmed by a positive urine test over the past 14 days
If female of child bearing potential, must agree to use birth control

Exclusion Criteria:

Please contact the site for more information
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: 16
Group description: Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
Eligibility criteria:
Inclusion Criteria:

Patients with locally advanced, histologically confirmed adenocarcinoma of the female breast. Women with ulcerated breast lesions may be enrolled. Patients with asymptomatic metastases to the bone are eligible.
Ability to provide written informed consent prior to study-specific screening procedures
TNM Stage:T3-4, N0-3 M0; Patients with asymptomatic bone metastases may be enrolled. Patients with large T2 tumors whose surgeons believe their results with breast conserving surgery will be improved by neoadjuvant therapy may be enrolled.
Age 18 years or older
Negative serum or urine pregnancy test within 7 days prior to starting therapy (female patients of childbearing potential).
Performance status 0-1
Required Initial Laboratory Data:
Granulocytes >=1,200/µl
Platelet count >=100,000/µl
Calculated Creatinine Clearance > 30 mL/min
Total bilirubin <= Upper Limit Normal
Alkaline Phosphatase <=Upper Limit Normal
SGPT, SGOT <=Upper Limit Normal
Normal chest x-ray

Exclusion Criteria:

HER2 positive breast cancer
Pregnant or lactating woman
Life expectancy < 3 months
Serious, uncontrolled, concurrent infection(s)
Any prior fluoropyrimidine therapy or other chemotherapy
Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hyper-sensitivity to 5-fluorouracil or known DPD deficiency.
Patients who have received more than four weeks of tamoxifen therapy for this malignancy.
Treatment for other carcinomas within the last five years, except cured non- melanoma skin and treated in-situ cervical cancer.
Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
Evidence of metastatic disease to sites other than the bone or with symptomatic bone lesions.
Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
Known, existing uncontrolled coagulopathy or concurrent treatment with Coumadin and Phenytoin
Any of the following laboratory values:
Abnormal hematologic values (neutrophils < 1.0 x 109/L, platelet count < 100 x 109/L)
Impaired renal function (estimated creatinine clearance <30ml/min as calculated with Cockcroft-Gault equation)
Serum bilirubin > upper normal limit.
SGOT, SGPT > upper normal limit
Intervention: Tetracycline
Trial phase: Phase 4
ATC code: A01AB13 | A02BD02 | A02BD08 | D06AA04 | J01AA07 | J01AA20 | J01RA08 | S01AA09 | S02AA08 | S03AA02
SMILES: [H][C@]12C[C@@]3([H])[C@H](N(C)C)C(O)=C(C(N)=O)C(=O)[C@@]3(O)C(O)=C1C(=O)c1c(O)cccc1[C@@]2(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 484
Group description: Topical tetracycline

Antibiotic:Topical tetracycline
Eligibility criteria:
Inclusion Criteria:

Presence of trichiasis:
no previous report of trichiasis surgery in at least one eye with trichiasis:
Agreement by at least one other family member accompanying the patient that, if the patient is randomized to the family-treatment arm, s/he also would be willing to receive antibiotic treatment
Age 18 or older

Exclusion Criteria:

other household members concurrently participating in the trial
Self-reported pregnancy
Documented allergy to tetracycline
Plans to move out of the region within 1 year.
Intervention: Dalcetrapib
Trial phase: Phase 2
SMILES: CCC(CC)CC1(C(=O)Nc2ccccc2SC(=O)C(C)C)CCCCC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 89
Group description: Dalcetrapib 900mg po daily for 24 weeks

dalcetrapib: 900mg po daily for 24 weeks
Eligibility criteria:
Inclusion Criteria:

adult patients, 18-75 years of age;
CHD or CHD risk equivalent;
body weight <125kg at visit 1.

Exclusion Criteria:

recent (within 3 weeks of screening) clinically significant coronary events;
history of statin-associated myopathy, or intolerance to statin;
history of malignancy (except for curatively treated basal cell or squamous cell cancer of the skin) during the 3 years prior to screening;
exposure to RO4607381 in past 12 months.