anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cholic Acid
Trial phase: Phase 3
ATC code: A05AA03
SMILES: [H][C@@]1(O)CC[C@@]2(C)[C@@]([H])(C1)C[C@@]([H])(O)[C@@]1([H])[C@]3([H])CC[C@]([H])([C@]([H])(C)CCC(=O)O)[C@@]3(C)[C@@]([H])(O)C[C@]21[H]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: All patients entered into the study and treated with Cholic Acid. 85 patients enrolled in the study and 79 received treatment (safety set).
Eligibility criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Clinical or biochemical evidence of liver disease, unexplained fat-soluble vitamin malabsorption, or peroxisomal dysfunction that compromises bile acid biosynthesis

Inclusion criteria for enrollment were:

Infants < age 3 months
Children presenting for evaluation of cholestasis defined as a conjugated bilirubin > 2mg/dl or increased serum bile acids
Older subjects of any age with cholestatic liver disease if urine screens suggested that they had inborn errors of bile acid metabolism
Confirmation of a diagnosis of an inborn error of bile acid synthesis based upon urine analysis by FAB-MS to determine whether specific abnormalities in bile acid synthesis are indicated
The patient and/or parent/legal guardian must have signed the written informed consent document before study start.
The patient must be willing and able to comply with all study assessments and procedures.
Intervention: ENFUVIRTIDE
Trial phase: Phase 2
ATC code: J05AX07
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1cnc[nH]1)NC(=O)[C@@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(C)=O)[C@@H](C)O)[C@@H](C)CC)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(=O)O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](C)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](Cc1ccccc1)C(N)=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 52
Group description: Participants in stratum A (age >= 3 years and less than 12 years received Enfuvirtide Subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose) and in stratum B (age >= 12 years and less than 17 years received Enfuvirtide Subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose).
Eligibility criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

Are 3 through 16 years of age and have the consent of parent or guardian.
Have a viral load of at least 5000 copies/ml.
Have taken at least 2 of the 3 licensed anti-HIV drug classes for at least 3 months.
Have been on stable therapy for at least 4 weeks.
Intervention: Capecitabine
Trial phase: Phase 3
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: Older Adult
Healthy volunteers: No
Participants at risk: 299
Group description: Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles
Eligibility criteria:
Patients with operable, histologically confirmed adenocarcinoma of the female breast.

TNM Stage per AJCC Cancer Staging Manual 6th edition:

T1-4 (Tumor size > 1 cm), N0, M0 or T1-4, N1-3, M0
Patients with bilateral, synchronous breast cancer are eligible as long as one primary tumor meets the criteria above.

Patients with HER2/neu positive, negative or unknown disease are eligible for this trial.

Patients whose tumors are HER2 positive by either immunohistochemistry 3+ staining or demonstrate gene amplification by FISH will be eligible to receive trastuzumab, as outlined in the protocol.

Age 65 years or older
Performance status 0-2 (Common Toxicity Criteria).

Prior treatment:

Surgical resection -

All tumor should be removed by either a modified radical mastectomy or a lumpectomy. Patients must be registered ≤ 84 days from mastectomy or within 84 days of axillary dissection if patient's most extensive breast surgery was a breast sparing procedure.
Node dissection: Axillary node dissection is not required. Management of the axilla is at the discretion of the treating physician. There is no restriction on eligibility based on the number of nodes removed.
Mastectomy: There should be no evidence of gross or microscopic invasive tumor at the surgical resection margins noted in the final surgery or pathology reports for patients who have had a modified radical mastectomy. Patients with close margins (tumor < 1 mm from margin) are eligible.
Segmental mastectomy (lumpectomy): Although clear margins are preferable, DCIS or LCIS at the surgical resection margin will not render a patient who has undergone a segmental mastectomy ineligible for this study. Invasive tumor at the final resection margin will render a patient ineligible.
No prior chemotherapy for this malignancy.
Patients with a history of hypersensitivity to 5-FU or known dihydropyrimidine dehydrogenase (DPD) deficiency are not eligible to participate.
Patients may receive up to four weeks of tamoxifen therapy for this malignancy and still be eligible for study entry. Patients who received tamoxifen or raloxifene for purposes of chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy should be discontinued before the patient is enrolled on this study.

Required Initial Laboratory Data:

Granulocytes > 1,500/µl
Platelet count ≥100,000/µl
Calculated Creatinine Clearance > 30 mL/min
Total bilirubin ≤ ULN
Intervention: Fluoxetine
Trial phase: Phase 2
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
Eligibility criteria:
Inclusion Criteria:

Meets criteria for alcohol use disorder and major depressive disorder.

Exclusion Criteria:

Meets criteria for bipolar disorder, schizoaffective disorder, or schizophrenia.
Hyper- or hypothyroidism, significant cardiac, neurologic, or renal impairment, and those with significant liver disease.
Receiving antipsychotic or antidepressant medication in the month prior to entering the study.
Use of any illicit substance abuse or dependence other than cannabis abuse (and alcohol abuse).
History of intravenous drug use.
Pregnancy, inability or unwillingness to use contraceptive methods.
Inability to read or understand study forms
Less than 15 years of age or over 18 years of age will be excluded.
Intervention: Sirolimus
Trial phase: Phase 2
ATC code: L01EG04 | L04AA10 | S01XA23
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.
Eligibility criteria:
Inclusion Criteria:

Biopsy-confirmed diagnosis of clinical extensive chronic GVHD with inadequate response to previous treatment and where secondary systemic therapy is indicated because of

Clinical progression of signs and symptoms of chronic GVHD in a previously involved organ, or
Development of signs and symptoms of chronic GVHD in a previously uninvolved organ, or
Absence of improvement after 3 months of primary treatment, or
Continued need for treatment with prednisone at doses >= 1.0 mg/kg/day for more than 2 months, without qualification for type of donor, graft or conditioning regimen
Patient or guardian able and willing to provide informed consent
Stated willingness to use contraception in women of child-bearing potential (Food and Drug Administration [FDA] requirement)
Stated willingness of the patient to comply with study procedures and reporting requirements
Stated willingness of the physician most involved in management of chronic GVHD (the "managing physician,") to comply with study procedures and reporting requirements

Exclusion Criteria:

Fungal or viral infection with no radiographic evidence of improvement during continued appropriate antimicrobial therapy
Cytomegalovirus (CMV) antigenemia unresponsive to antiviral therapy
Active disseminated varicella zoster virus (VZV) infection with persistent non-crusted lesions
Inability to tolerate oral medications
Absolute neutrophil count (ANC) < 1500/uL
Platelet count < 50,000/uL
Persistent or recurrent malignancy, including histopathologic evidence of myeloma or lymphoma; patients with breakpoint cluster region-abelson (bcr/abl) detected by polymerase chain reaction (PCR) assay as the only evidence of persistent chronic myeloid leukemia may be enrolled
Pregnancy
Known history of hypersensitivity to sirolimus
Intervention: Glipizide
Trial phase: Phase 3
ATC code: A10BB07
SMILES: Cc1cnc(C(=O)NCCc2ccc(S(=O)(=O)NC(=O)NC3CCCCC3)cc2)cn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 584
Group description: The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
Eligibility criteria:
Inclusion Criteria:

Patients who are at least 18 years of age and not older than 78 with type 2 diabetes mellitus
Intervention: Cisplatin
Trial phase: Phase 3
ATC code: L01XA01
SMILES: Cl[Pt]Cl.N.N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.

cisplatin : Given IV

radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks
Eligibility criteria:
List of Inclusion Criteria:

Histologically or cytologically confirmed squamous cell carcinoma of the head and neck

Stage III or IV* disease

One of the following primary tumor sites:

Oral cavity

No mandible invasion
Oropharynx
Hypopharynx
Larynx

The following primary tumor sites are excluded:

Nasal cavity
Paranasal cavity
Nasopharynx NOTE: *No evidence of distant metastases by chest x-ray, abdominal ultrasound, or CT scan (for patients with liver function test abnormalities) or bone scan (for patients with local symptoms)
At least 1 uni- or bi-dimensionally measurable lesion

PATIENT CHARACTERISTICS:

Age

Over 18

Performance status

WHO 0-1

Life expectancy

Not specified

Hematopoietic

Neutrophil count > 1,500/mm^3
Platelet count > 100,000/mm^3
Hemoglobin > 10 g/dL

Hepatic

Bilirubin normal
AST or ALT within eligibility range
Alkaline phosphatase within eligibility range

Renal

Creatinine clearance > 60 mL/min

Cardiovascular

No unstable cardiac disease despite treatment
No myocardial infarction within the past 6 months

Pulmonary

No chronic obstructive pulmonary disease, defined as requiring hospitalization for pneumonia or respiratory decompensation within the past year

Obstruction caused by the tumor allowed

Neurologic

No symptomatic peripheral neuropathy > grade 2
No symptomatic altered hearing > grade 2
No history of significant neurologic or psychiatric disorders, including dementia or seizures

Other

No active drug addiction, including alcohol, cocaine, or intravenous drugs within the past 6 months
No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or other cancer curatively treated by surgery alone
No active, clinically significant, uncontrolled infection
No autoimmune disease requiring therapy
No unhealed or clinically active peptic ulcer disease
No hypercalcemia
No other serious illness or medical condition
No involuntary weight loss > 25% of body weight within the past 2 months
HIV negative
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy

Surgery

No prior organ transplantation

No prior surgery for this cancer

Biopsy allowed

Other

More than 30 days since prior participation in another investigational study
No other concurrent anticancer therapy
Intervention: Metformin
Trial phase: Phase 2
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
Eligibility criteria:
Inclusion Criteria:

Participants with the Metabolic Syndrome, which is defined as having 3 or more of the following 5 alterations:

Abdominal obesity (waist measurement >39.8 inches in men, >34.4 inches in women)
Elevated triglycerides (>150 mg/dl)
Low HDL or "good" cholesterol (<40 mg/dl in men or <50 mg/dl in women)
Elevated blood pressure (>130/85) or treatment for high blood pressure
Elevated fasting blood sugar (>100 mg/dl)

Exclusion Criteria:

Diabetes treated with medication
Blood pressure >160/100 mmHg
Clinical Congestive Heart Failure
Anemia with hematocrit <32%
Asthma or Chronic Obstructive Pulmonary Disease (COPD) requiring daily medication or use of home oxygen therapy
Major surgery planned within the next six months
A recent, unexplained weight loss of >10% of body weight in the past 6 months
A known allergy or hypersensitivity to Metformin
History of hepatitis or cirrhosis
History of kidney disease (defined as serum creatinine >1.4 mg/dL in men, >1.3 mg/dL in women)
Pregnancy or the absence of an effective method of contraception
Illicit drug or alcohol abuse
Cancer requiring treatment currently or recently completed treatment in the last 2 months
Intervention: Sarizotan
Trial phase: Phase 3
SMILES: Fc1ccc(-c2cncc(CNC[C@H]3CCc4ccccc4O3)c2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 252
Group description: Subjects received sarizotan 1 milligram orally twice daily for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

The subject is an out-patient.
The subject presents with a diagnosis of idiopathic Parkinson's disease.
Prior therapy with all registered Parkinsonian medication is allowed.

Exclusion Criteria:

(For female subjects) The subject is pregnant or lactating.
The subject is participating in another clinical study or has done so within the past 30 days.
The subject has received neurosurgical intervention related to PD.
The subject has relevant renal impairment.
The subject has relevant hepatic impairment.
The subject is suffering from any dementia or psychiatric illness.
The subject has a history of allergic asthma.
Intervention: Sarizotan
Trial phase: Phase 3
SMILES: Fc1ccc(-c2cncc(CNC[C@H]3CCc4ccccc4O3)c2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
Eligibility criteria:
Inclusion Criteria:

The participant is an out-patient
The participant presents with a diagnosis of idiopathic Parkinson's disease
Prior therapy with all registered Parkinsonian medication is allowed

Exclusion Criteria:

(For female participants) The participant is pregnant or lactating
The participant is participating in another clinical study or has done so within the past 30 days
The participant has received neurosurgical intervention related to Parkinson's disease
The participant has relevant renal impairment
The participant has relevant hepatic impairment
The participant is suffering from any dementia or psychiatric illness
The participant has a history of allergic asthma
Intervention: Fluoxetine
Trial phase: Phase 3
ATC code: N06AB03 | N06CA03
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
Eligibility criteria:
Inclusion Criteria:

Female or male outpatients 13 to 18 years of age.
Fulfillment of the American College of Rheumatology (ACR) criteria for primary fibromyalgia.
Ability to understand and cooperate with study procedures.
Provision of parental written informed consent and verbal and written assent from the adolescent for participation in the study.

Exclusion Criteria:

Unwillingness or inability on the part of the parent to provide written informed consent or for the adolescent to provide verbal and written assent.
Lifetime history of psychosis, hypomania or mania.
Diagnosis of alcohol or substance abuse or dependence within 6 months prior to screening visit.
Patients judged to be at serious suicide or homicide risk.
Girls who are pregnant or lactating. Girls of childbearing potential who are not using a medically accepted method of contraception (including barrier or hormonal methods).
Clinically unstable medical or psychiatric conditions that could interfere with the absorption, metabolism, excretion, or safety of fluoxetine or interfere with the assessment of disease severity.
Inability to exclude traumatic injury, regional or structural rheumatic disease, or infectious arthropathy as the etiology of their relevant fibromyalgia symptoms and that would interfere with interpretation of outcome measures (e.g., osteoarthritis, bursitis, tendonitis).
History of an autoimmune disease or inflammatory arthritis, such as systemic lupus erythematosis (SLE) or rheumatoid arthritis (RA).
Treatment with a monoamine oxidase inhibitor, tricyclic, selective serotonin reuptake inhibitor (SSRI) antidepressant, or lithium within 2 weeks prior to beginning study medication.
Treatment with analgesic medication (with the exception of acetaminophen and over-the-counter NSAIDs) within one week prior to beginning study medication.
Treatment with any other excluded medication that cannot be discontinued at the screening visit.
Previous treatment with fluoxetine.
Treatment with any investigational medications within 30 days prior to screening.
Intervention: Lipoic acid
Trial phase: Not Applicable
ATC code: A16AX01
SMILES: O=C(O)CCCCC1CCSS1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 17
Group description: Antioxidant
Eligibility criteria:
Inclusion Criteria:

Impaired glucose tolerance

Exclusion Criteria:

Diagnosis of diabetes
Taking an ACE inhibitor (ACE-I), angiotensin II receptor blocker (ARB), or aspirin
Have systolic blood pressure >140 mm Hg
Have a chronic inflammatory disorder (i.e. rheumatoid arthritis, inflammatory bowel disease, sinusitis)
Vascular disease (cardiac, peripheral, cerebral)
Renal insufficiency or hepatic abnormalities
Gastrointestinal bleeding (defined as gastric or duodenal ulcer, hematemesis, and/or blood in the stool) or significant other upper gastrointestinal problems (i.e. gastritis) within the previous 6 months
Anemia or a history of bleeding disorder
Have a history of ARB or aspirin allergy
Have the syndrome of asthma, rhinitis, and nasal polyps
Have other medical problems which would preclude taking potential study medications for 12 months
Are pregnant or have a positive pregnancy test
Are breast feeding
Are unable or unwilling to tolerate having one catheter in each arm for 4 hours
Have health status such that the envisioned blood sampling would confer a physiologic risk
Have other physical, social, or behavioral problems which would decrease the likelihood that they would remain in the study for 12 months
Do not appear capable of giving informed consent
Intervention: Spironolactone
Trial phase: Phase 3
ATC code: C03DA01
SMILES: [H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Spironolactone

Spironolactone: 25mg tablet daily for 9 months
Eligibility criteria:
Inclusion Criteria:

Ambulatory
Medically stable
Ages 60 or older
Diagnosis of diastolic heart failure

Exclusion Criteria:

Valvular heart disease
Significant change in cardiac medication within the past 4 weeks
Uncontrolled hypertension
Recent or debilitating stroke
Cancer or other noncardiovascular conditions with life expectancy less than 2 years
Anemia
Elevated serum potassium
Renal insufficiency
Psychiatric disease (uncontrolled major psychoses, depression, dementia, or personality disorder)
Allergy to spironolactone; currently taking spironolactone or any aldosterone antagonist
Plans to leave area within 1 year
Refuses informed consent
Failure to pass screening tests: pulmonary function, echocardiogram, or exercise
Contra-indications to magnetic resonance imaging [MRI] (indwelling metal-containing prosthesis; pacemaker or defibrillator; history of welding occupation; uncontrollable claustrophobia)
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: 65
Group description: Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
Eligibility criteria:
Inclusion Criteria:

Males or females over the age of 40
Scheduled to undergo pneumonectomy or lobectomy

Exclusion Criteria:

History (hx) of atrial fibrillation
Prior severe side effects from amiodarone
Elevated liver enzymes >3 times the upper limit of normal (UNL)
QTc interval > 450 ms
Receiving class Ia or class III antiarrhythmics