anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Deferasirox
Trial phase: Phase 3
ATC code: V03AC03
SMILES: O=C(O)c1ccc(-n2nc(-c3ccccc3O)nc2-c2ccccc2O)cc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1683
Group description: Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
Eligibility criteria:
Inclusion Criteria:

Male or female patients greater than or equal to 2 years of age
Documented congenital disorder of red blood cells (e.g., β-thalassemia major, sickle cell anemia, diamond-blackfan anemia) requiring ongoing blood transfusions

Cannot be adequately treated with a locally approved iron chelator due to one of the following reasons:

Documented non-compliance, defined as having taken less than 50% of the prescribed chelation therapy doses in the 12 months prior to study entry
Contraindications, unacceptable toxicities and/or documented poor response to locally approved iron chelators despite proper compliance
History of at least 20 blood transfusions (equivalent to 100 mL/kg of packed red blood cells (PRBC])
Serum ferritin value greater than or equal to 1000 µg/L
Ability to comply with all study-related procedures, medications, and evaluations

Exclusion Criteria:

Ongoing treatment with another iron chelator (Any other iron chelation therapy must be discontinued at least 24 hours prior to study entry.)
Patients who meet the eligibility criteria for any other ongoing Novartis sponsored clinical study protocol with deferasirox and who have geographic access to these sites
Patients unable to tolerate (or who have unacceptable toxicities to) prior treatment with deferasirox
Serum creatinine above the upper limit of normal at screening.
Patients with ALT ≥ 500 U/L at screening.
Evidence of chelation-related cataracts or hearing loss within 4 weeks prior to baseline
Pregnancy (as indicated by serum β-HCG pregnancy test at screening for all female patients with the potential to become pregnant) and patients who are breastfeeding
Patients treated with systemic investigational drug within 4 weeks prior to or with topical investigational drug within 7 days prior to the baseline visit

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Melatonin
Trial phase: Phase 2
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Melatonin
Eligibility criteria:
Inclusion Criteria:

Diagnosed with uncomplicated hypertension
Currently being treated with Atenolol (a beta-blocker)

Exclusion Criteria:

History of medical illness other than essential hypertension
Personal or family history of psychiatric illness
Current use of any medication other than anti-hypertensive drugs
Any recent travel across time zones
History of working various shifts on an irregular basis
Intervention: MYCOPHENOLATE MOFETIL
Trial phase: Phase 4
SMILES: COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)OCCN1CCOCC1)C(=O)OC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: 250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
Eligibility criteria:
Inclusion Criteria:

Received kidney transplant
Receiving immunosuppressive regimen that includes MMF
Patients with GI side effects on standard MMF doses or patients on reduced dose MMF with existing but tolerated/controlled GI side effects.
At least 18 years of age
Willing to provide written informed consent
Able to meet all study requirements including completing questionnaires and completing four study visits.

Exclusion Criteria:

Patients with GI symptoms assumed or known not to be caused by medroxyprogesterone acetate (MPA) therapy (e.g. oral bisphosphonate induced, infectious diarrhea)
Acute rejection < 1 week prior to study enrollment
Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating and who is unwilling to use effective means of contraception
Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements
Undergoing acute medical intervention or hospitalization
Any other medical condition that, in the opinion of the site investigator based on recall or chart review, would interfere with completing the study, including, but not limited to, visual problems or cognitive impairment.
Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment.

Additional protocol-defined inclusion/exclusion criteria may apply.
Intervention: TESTOSTERONE UNDECANOATE
Trial phase: Phase 2
SMILES: CCCCCCCCCCC(=O)O[C@H]1CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@]4(C)[C@H]3CC[C@]12C
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: oral testosterone undecanoate, 80mg twice daily (Andriol Testocaps, Organon, The Netherlands) for 8 weeks

Testosterone undecanoate: Licensed for androgen deficiency

Active and placebo given in a cross-over design
Eligibility criteria:
Inclusion Criteria:

Men
Aged 35 to 75 years
Angiographically proven coronary artery disease (70 percent lesion in at least one major coronary artery, or major branch), including patients post-coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI)
Plasma testosterone less than or equal to 12 nmol/l
Normal prostate specific antigen (PSA; normal range 0 - 4 g/l)
Willing to give written informed consent

Exclusion Criteria:

Significant arrhythmia, particularly those which would affect interpretation of the ST-segment of the ECG
Treatment with digitalis
Treatment with testosterone or similar hormonal therapy
Thoracic or abdominal surgery within the previous 3 months
Haemoglobin >16 g/dL
Haematocrit >50 percent
History of hormone-dependent cancer such as prostate or breast cancer
Hypercalcaemia
Nephrosis
Pacemaker or automated implantable cardiac defibrillator
Implanted ferromagnetic arterial clips
Left ventricular hypertrophy
New York Heart Association (NYHA) III or IV functional class
Intolerance of confined spaces
Previous allergic reaction to Gadolinium
Participation in another research study within the previous 60 days
Unwilling to give written informed consent
Intervention: TESTOSTERONE UNDECANOATE
Trial phase: Phase 2
SMILES: CCCCCCCCCCC(=O)O[C@H]1CC[C@H]2[C@@H]3CCC4=CC(=O)CC[C@]4(C)[C@H]3CC[C@]12C
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: identical to active medication, taken in an identical way to the active arm
Eligibility criteria:
Inclusion Criteria:

Men
Aged 35 to 75 years
Angiographically proven coronary artery disease (70 percent lesion in at least one major coronary artery, or major branch), including patients post-coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI)
Plasma testosterone less than or equal to 12 nmol/l
Normal prostate specific antigen (PSA; normal range 0 - 4 g/l)
Willing to give written informed consent

Exclusion Criteria:

Significant arrhythmia, particularly those which would affect interpretation of the ST-segment of the ECG
Treatment with digitalis
Treatment with testosterone or similar hormonal therapy
Thoracic or abdominal surgery within the previous 3 months
Haemoglobin >16 g/dL
Haematocrit >50 percent
History of hormone-dependent cancer such as prostate or breast cancer
Hypercalcaemia
Nephrosis
Pacemaker or automated implantable cardiac defibrillator
Implanted ferromagnetic arterial clips
Left ventricular hypertrophy
New York Heart Association (NYHA) III or IV functional class
Intolerance of confined spaces
Previous allergic reaction to Gadolinium
Participation in another research study within the previous 60 days
Unwilling to give written informed consent
Intervention: Sucroferric oxyhydroxide
Trial phase: Phase 4
ATC code: V03AE05
SMILES: O.O.O.OCC1OC(OC2(CO)OC(CO)C(O)C2O)C(O)C(O)C1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 47
Group description: 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Eligibility criteria:
Inclusion Criteria:

Patients between 2 to 21 years of age
Patients on stable hemodialysis (HD) or peritoneal dialysis (PD) regimen for 3 months for ≥ 3 months
Non-dialysis dependent (NDD) patients with glomerular filtration rate (GFR) <60
Hemoglobin (Hgb) ≥ 11g/dL to ≤ 13.5g/dL
Ferritin ≤ 800 ng/mL
Transferrin saturation (TSAT) ≥ 20% to ≤ 50%
Received stable erythropoietin (EPO) regimen for ≥ 8 weeks prior to the qualifying screening visit

Exclusion Criteria:

Known hypersensitivity to iron sucrose
Severe diseased of the liver, cardiovascular system, or hemopoietic system
Serious infection requiring hospitalization
Significant blood loss within the last 3 months
Bleeding disorders
Pregnancy / Lactation
Actively being treated for asthma
Hemoglobinopathy
Receiving a myelosuppressive drug
Intervention: Sucroferric oxyhydroxide
Trial phase: Phase 4
ATC code: V03AE05
SMILES: O.O.O.OCC1OC(OC2(CO)OC(CO)C(O)C2O)C(O)C(O)C1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 47
Group description: 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Eligibility criteria:
Inclusion Criteria:

Patients between 2 to 21 years of age
Patients on stable hemodialysis (HD) or peritoneal dialysis (PD) regimen for 3 months for ≥ 3 months
Non-dialysis dependent (NDD) patients with glomerular filtration rate (GFR) <60
Hemoglobin (Hgb) ≥ 11g/dL to ≤ 13.5g/dL
Ferritin ≤ 800 ng/mL
Transferrin saturation (TSAT) ≥ 20% to ≤ 50%
Received stable erythropoietin (EPO) regimen for ≥ 8 weeks prior to the qualifying screening visit

Exclusion Criteria:

Known hypersensitivity to iron sucrose
Severe diseased of the liver, cardiovascular system, or hemopoietic system
Serious infection requiring hospitalization
Significant blood loss within the last 3 months
Bleeding disorders
Pregnancy / Lactation
Actively being treated for asthma
Hemoglobinopathy
Receiving a myelosuppressive drug
Intervention: Sucroferric oxyhydroxide
Trial phase: Phase 4
ATC code: V03AE05
SMILES: O.O.O.OCC1OC(OC2(CO)OC(CO)C(O)C2O)C(O)C(O)C1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 47
Group description: 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
Eligibility criteria:
Inclusion Criteria:

Patients between 2 to 21 years of age
Patients on stable hemodialysis (HD) or peritoneal dialysis (PD) regimen for 3 months for ≥ 3 months
Non-dialysis dependent (NDD) patients with glomerular filtration rate (GFR) <60
Hemoglobin (Hgb) ≥ 11g/dL to ≤ 13.5g/dL
Ferritin ≤ 800 ng/mL
Transferrin saturation (TSAT) ≥ 20% to ≤ 50%
Received stable erythropoietin (EPO) regimen for ≥ 8 weeks prior to the qualifying screening visit

Exclusion Criteria:

Known hypersensitivity to iron sucrose
Severe diseased of the liver, cardiovascular system, or hemopoietic system
Serious infection requiring hospitalization
Significant blood loss within the last 3 months
Bleeding disorders
Pregnancy / Lactation
Actively being treated for asthma
Hemoglobinopathy
Receiving a myelosuppressive drug
Intervention: Glucosamine hydrochloride
Trial phase: Phase 4
SMILES: Cl.NC1C(O)OC(CO)C(O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Participants will be given anti-D in an outpatient setting. Participants will be observed for any adverse effects for 1 hour postinfusion. Some participants may require additional doses of anti-D later in the study, depending on individual response to the drug; participants may receive 1 to 6 doses of anti-D.

Anti-D: 30-minute infusion administered in an outpatient setting
Eligibility criteria:
Inclusion Criteria for All Participants:

HCV-infected
Currently on treatment for HCV OR plan to begin treatment for HCV at the start of this study
Platelet count less than 50,000 cells/microl
Hemoglobin greater than 10 g/dl OR greater than 11 g/dl if peginterferon treatment-naive
Red blood cells are Rh (D) antigen-positive
Negative Coombs direct antibody test

Inclusion Criteria for HIV Infected Group:

HIV-infected

Inclusion Criteria for HIV Uninfected Group:

HIV-uninfected

Exclusion Criteria:

Prior treatment with intravenous immunoglobulin (IVIG), anti-D, or other medication for the treatment of thrombocytopenia within 30 days of study entry
Prior serious reaction to plasma products
Absence of spleen
Evidence of thrombotic thrombocytopenic purpura (TTP) OR cause of thrombocytopenia other than HCV infection, HCV treatment, or HIV infection
Intervention: Prazosin
Trial phase: Not Applicable
ATC code: C02CA01 | C02LE01
SMILES: COc1cc2nc(N3CCN(C(=O)c4ccco4)CC3)nc(N)c2cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Prazosin flexible dose titration up to 12 mg per day.

Prazosin: FDA approved medication for hypertension
Eligibility criteria:
Inclusion Criteria:

Age 18-70 years
Current DSM-IV diagnosis of alcohol dependence or cocaine dependence with no use in last 30 days
Capacity to provide informed consent
Actively enrolled in chemical dependency treatment at VA Puget Sound English fluency

Exclusion Criteria:

Evidence of significant abuse of opiates, PCP, sedatives or anxiolytics
Suicidal ideation
DSM IV diagnosis of bipolar mood disorder, schizophrenia or schizoaffective disorder
Significant acute or chronic medical illness, including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension (systolic < 110), or orthostatic hypotension (systolic drop > 20mmHg after two minutes standing or any drop with dizziness), insulin-dependent diabetes mellitus; chronic renal or hepatic failure, pancreatitis, gout, M ni re's disease, benign positional vertigo, narcolepsy
Concomitant use of alpha-1 antagonists History of prazosin-sensitivity Women who are pregnant, nursing infant(s), or of childbearing potential and not using a contraceptive method judged by the investigator to be effective
Non-compliance with outpatient chemical dependency treatment
Intervention: Testosterone
Trial phase: Phase 4
ATC code: G03BA03 | G03EA02
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Male
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 106
Group description: Topical testosterone gel 1% (active formulation): Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day.
Eligibility criteria:
Inclusion Criteria:

Community dwelling, ages 65 and older
Self-reported difficulty in climbing 10 steps without resting, or difficulty in walking 2 or 3 blocks outside on level ground
A score of 4 to 9 on the Short Physical Performance Battery (mild to moderate physical impairment)
Total serum testosterone level (TT) < 350 ng/dL and > 100 ng/dL
Without dementia (Mini-Mental State Examination [MMSE] score > 24)

Exclusion Criteria:

Use of testosterone, anabolic steroids, dehydroepiandrosterone (DHEA), androstenedione or recombinant growth hormone (rGH) in the past year
Alcohol or drug abuse
Use of anti-convulsants or glucocorticoids (equivalent to prednisone > 20 mg/day)
Prostate cancer, breast cancer or other cancers with life expectancy < 5 years
Limiting neuromuscular, joint or bone disease, or history of stroke with residual neurological problems

Any neurological condition that would impact cognitive functioning including:

epilepsy
multiple sclerosis
HIV
Parkinson's disease
stroke
other focal lesion
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I psychiatric disorder in past year or use of psychotropic medications in 6 months
Abnormal prostate examination; PSA > 4 ng/mL; or BPH symptom score > 21
Unstable angina, New York (NY) class III or IV congestive heart failure or myocardial infarction within 3 months of entry
Abnormal laboratory values (at discretion of principal investigator)
Untreated thyroid disease; systolic blood pressure > 160 or diastolic > 100 mm Hg
Body mass index > 40 kg/m2
Untreated severe obstructive sleep apnea
Intervention: Lamotrigine
Trial phase: Not Applicable
ATC code: N03AX09
SMILES: Nc1nnc(-c2cccc(Cl)c2Cl)c(N)n1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 6
Group description: The drug lamotrigine will be given for 9 weeks prior to imaging session. A rescue drug, Gabapentin, will be provided for pain control. Patients will taper off the Gabapentin 2 weeks before each scan date. Patients will be required to maintain a pain diary during the study, documenting the perceived effects of the drug on the severity of their pain and keeping track of their subjective pain ratings day to day. Patients will also complete the McGill Pain Questionnaire at each visit.

Lamotrigine: : 25mg and 50mg tablets
Eligibility criteria:
Inclusion Criteria:

18-60 years of age
Right-handed non-smokers
Diagnosed with facial pain
Continuous pain for more than 3 months
Spontaneous pain greater than 3 of 10
Allodynia to brush greater than 5 of 10

Exclusion Criteria:

Medications
Depression
Significant medical problems
Claustrophobia
Abnormal EKG
Significant drug or alcohol history
Positive drug screen
Weight greater than 285 lbs
History of allergy to anticonvulsants
Tattoos with metallic ink on upper body
Any neurostimulator devices, or metal cochlear, ocular, or cardiac implants or other metal near vital areas
Exposure to shrapnel or metal filings
Other metallic surgical hardware
Intervention: Gemcitabine
Trial phase: Phase 2
ATC code: L01BC05
SMILES: Nc1ccn([C@@H]2O[C@H](CO)[C@@H](O)C2(F)F)c(=O)n1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Gemcitabine, genistein (Novasoy), Tumor biopsy Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed breast cancer

Stage IV disease
Clinical and/or radiological evidence of metastatic disease

Measurable disease

Prior radiotherapy allowed provided there is ≥ 1 measurable disease site outside the radiation field

No active CNS metastases

Previously treated CNS metastases allowed provided disease is stable for ≥ 3 months without steroids or antiseizure medications

Hormone receptor status:

Not specified

PATIENT CHARACTERISTICS:

Sex

Female

Menopausal status

Not specified

Performance status

SWOG 0-2

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 10 g/dL

Hepatic

Bilirubin ≤3.0 mg/dL
AST and ALT ≤ 2.5 times upper limit of normal

Renal

Creatinine ≤ 1.5 mg/dL

Other

Not pregnant or nursing
Fertile patients must use effective contraception
No serious systemic disorder that would preclude study compliance
No history of another malignancy except curatively treated carcinoma of the cervix or basal cell or squamous cell skin cancer in complete remission
No unresolved bacterial infection requiring antibiotic treatment
No known HIV-1 positivity

PRIOR CONCURRENT THERAPY:

Biologic therapy

At least 3 weeks since prior biologic therapy

Chemotherapy

Prior adjuvant chemotherapy allowed

Prior adjuvant or neoadjuvant taxane-based therapy or taxane therapy for metastatic disease allowed

Patient must have failed therapy within 2 years after completion of treatment
At least 3 weeks since prior chemotherapy
No more than 2 prior cytotoxic chemotherapy regimens for metastatic disease
No prior gemcitabine hydrochloride
No other concurrent chemotherapy

Endocrine therapy

See Disease Characteristics

At least 2 weeks since prior and no concurrent hormonal therapy

Must have documented disease progression during prior hormonal therapy

Radiotherapy

See Disease Characteristics
At least 4 weeks since prior radiotherapy and recovered
No concurrent radiotherapy

Surgery

At least 3 weeks since prior surgery

Other

At least 3 weeks since prior investigational therapy

At least 1 week since prior soy supplements (e.g., soy-based pills, liquids, or concentrates)

Dietary soy as part of a meal (e.g., tofu) allowed once a week

No concurrent nutritional supplements, herbal agents, or high doses of antioxidants (e.g., vitamins C, D, or E) that may interact with, antagonize, alter, or imitate the potential effects of gemcitabine hydrochloride or genistein

A single daily multivitamin is allowed
No other concurrent immunotherapy
No other concurrent experimental medication
Concurrent anticoagulants, appetite stimulants, and replacement steroids allowed
Intervention: Ifosfamide
Trial phase: Phase 2
ATC code: L01AA06
SMILES: O=P1(NCCCl)OCCCN1CCCl
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Cytoxan+Ifosfamide, Filgrastim pre samarium.'Sm-EDTMP (low dose). once counts recover, Sm-EDTMP (high dose) given. Peripheral blood stem cell transplantation is done 14 days later.

filgrastim: Filgrastim will be administered post post chemotherapy until target WBC count is achieved.

ifosfamide: Ifosfamide administered IV.

peripheral blood stem cell transplantation: Peripheral blood stem cell transplantation is done 14 days after 2nd dose of Samarium is delivered

Sm-EDTMP (low dose): Sm-EDTMP (low dose) administered after autologous stem cell collection

sm-EDTMP (higher dose): Upon blood cell count recovery from Sm-EDTMP (low dose), Sm-EDTMP (higher dose) is administered followed in 14 days by peripheral blood stem cell transplantation.
Eligibility criteria:
Inclusion

Diagnosis of osteosarcoma

High-risk disease, meeting 1 of the following criteria:

Recurrent disease
Refractory to conventional therapy
Newly diagnosed metastatic disease with ≥ 4 pulmonary nodules or multiple bone lesions
Unresectable primary tumor
Prior intralesional resection allowed
Measurable disease by technetium Tc 99m diphosphonate bone scan
Refractory to all standard therapies or highly unlikely to respond to conventional treatment
Performance status Karnofsky 60-100%
Life expectancy more than 8 weeks
Absolute neutrophil count > 500/mm^3
Platelet count > 50,000/mm^3
Creatinine clearance > 70 mL/min OR * Radioisotope glomerular filtration rate normal
Recovered from prior chemotherapy

Exclusion

Pregnant or nursing
Positive pregnancy test for females of childbearing potential
Fertile patients do not agree to use effective contraception
Prior radiotherapy to the site of currently active disease
Concurrent enrollment on protocol JHOC-J0094 allowed