anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Brivaracetam
Trial phase: Phase 3
ATC code: N03AX23
SMILES: CCC[C@@H]1CC(=O)N([C@@H](CC)C(N)=O)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 99
Group description: Brivaracetam 20 mg/day, 10 mg administered twice a day
Eligibility criteria:
Inclusion Criteria:

Subjects were from 16 to 70 years, both inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted
Subjects with well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
Subjects had a history of partial onset seizures (POS) whether or not secondarily generalized (Type I seizures according to the ILAE classification)
Subjects had at least 2 POS whether or not secondarily generalized per month during the 3 months preceding Visit 1
Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week Baseline Period
Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant AED

Exclusion Criteria:

History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 3
History or presence of status epilepticus during the year preceding Visit 1 or during Baseline
Intervention: Brivaracetam
Trial phase: Phase 3
ATC code: N03AX23
SMILES: CCC[C@@H]1CC(=O)N([C@@H](CC)C(N)=O)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 99
Group description: Brivaracetam 50 mg/day, 25 mg administered twice a day
Eligibility criteria:
Inclusion Criteria:

Subjects were from 16 to 70 years, both inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted
Subjects with well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
Subjects had a history of partial onset seizures (POS) whether or not secondarily generalized (Type I seizures according to the ILAE classification)
Subjects had at least 2 POS whether or not secondarily generalized per month during the 3 months preceding Visit 1
Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week Baseline Period
Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant AED

Exclusion Criteria:

History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 3
History or presence of status epilepticus during the year preceding Visit 1 or during Baseline
Intervention: Brivaracetam
Trial phase: Phase 3
ATC code: N03AX23
SMILES: CCC[C@@H]1CC(=O)N([C@@H](CC)C(N)=O)C1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Brivaracetam 100 mg/day, 50 mg administered twice a day
Eligibility criteria:
Inclusion Criteria:

Subjects were from 16 to 70 years, both inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted
Subjects with well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
Subjects had a history of partial onset seizures (POS) whether or not secondarily generalized (Type I seizures according to the ILAE classification)
Subjects had at least 2 POS whether or not secondarily generalized per month during the 3 months preceding Visit 1
Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week Baseline Period
Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic drugs (AEDs). Vagal nerve stimulation was allowed and was not counted as a concomitant AED

Exclusion Criteria:

History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 3
History or presence of status epilepticus during the year preceding Visit 1 or during Baseline
Intervention: Lapatinib
Trial phase: Phase 2
ATC code: L01EH01 | L01XE07
SMILES: CS(=O)(=O)CCNCc1ccc(-c2ccc3ncnc(Nc4ccc(OCc5cccc(F)c5)c(Cl)c4)c3c2)o1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Lapatinib, 1500mg once daily, was administered for 7 days prior to, and for the duration of Intensity Modulated Radio Therapy (IMRT), delivered by G.E. Healthcare 1.5T MR, systems revision 12.0 M5 for a total dose of 70Gy delivered in 2-2.12 Gy/ fraction over the course of 6.5-7 weeks.
Eligibility criteria:
Inclusion Criteria:

Newly diagnosed stage III-IV HNSCC, pathologically confirmed (HNSCC from unknown primary sites are allowed)
No evidence of distant metastasis
No prior radiation therapy to the head and neck sites.
Able to sign a study-specific informed consent form.
Women of childbearing potential and men with partners capable of producing offspring must be willing to practice acceptable methods of birth control to prevent pregnancy.
Left ventricular ejection fraction (LVEF) within the institutional normal range as measured by ECHO (If ECHO cannot be performed or if the Investigator feels that it is not conclusive to evaluate LVEF, then a MUGA scan should be performed).

Having one of the following parameters that would preclude the use of concurrent CRT:

ECOG PS > 2.
Creatinine > 1.3 or calculate or measure creatinine clearance < 60 ml/min.
AST or ALT > 1.5 times normal limit but < 3 times normal limit
Total bilirubin > 1.5 mg/dL but < 3mg/dL
History of hearing loss that would preclude cisplatin chemotherapy. These would include the existing need of a hearing aid or a >= 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test.
Pre-existing peripheral neuropathy that would preclude cisplatin chemotherapy
Refuse or cannot tolerate chemotherapy
Age 18 years or older

Exclusion Criteria:

Known hypersensitivity to lapatinib or any of the excipients of this product (quinazolines).
Uncontrolled angina, arrhythmia or congestive heart failure at the time of HNSCC diagnosis and treatment.
History of myocardial infarction < 6 months from study entry.
Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
Prior treatment with EGFR or Her2/Neu directed therapies.
HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with Lapatinib.
Absolute neutrophil count < 1500/uL
Intervention: Ziprasidone
Trial phase: Phase 2
ATC code: N05AE04
SMILES: O=C1Cc2cc(CCN3CCN(c4nsc5ccccc45)CC3)c(Cl)cc2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
Eligibility criteria:
Inclusion Criteria:

Diagnosis of bipolar disorder type II, or unipolar major depressive disorder
If female, non-pregnant/non-lactating
If a sexually active female of reproductive potential, must be using adequate contraception (i.e., oral contraceptives, barrier protection, or prior tubal ligation)
Currently meets Diagnostic and Statistical Manual, 4th edition (DSM-IV) criteria for a major depressive episode, and presence of 2 or 3 DSM-IV manic criteria, present for the majority of the time during the past week.
All other baseline psychotropic drugs will be allowed to be continued unchanged. However, if antidepressant use has been initiated in the previous 2 months, or was thought to be contributing to the depressive mixed state, then antidepressant medications would be discontinued 4 weeks before starting the study.
Intervention: Olanzapine
Trial phase: Phase 3
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 148
Group description: Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
Eligibility criteria:
Inclusion Criteria:

Meet DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) criteria for Bipolar I Disorder Most Recent Episode Manic or Mixed (with or without psychotic features)
have a history of at least 2 previously documented mood episodes associated with Bipolar I Disorder (1 of which must be a manic or mixed episode) that required medical treatment within the past 3 years
a total score of at least 20 on the YMRS at screening and at Day 1 of the study.

Exclusion Criteria:

Meet DSM-IV criteria for any type of episode associated with bipolar disorder other than Bipolar I Disorder Most Recent Episode Manic or Mixed
Meet DSM-IV criteria for rapid cycling
Meet DSM-IV criteria for schizoaffective disorder
Known or suspected borderline or antisocial personality disorder
be, in the opinion of the investigator, at significant immediate risk for suicidal or violent behavior during the course of the study based on current status or prior history (e.g., suicide attempts during previous episodes).
Intervention: Metoprolol Succinate
Trial phase: Phase 4
SMILES: COCCc1ccc(OCC(O)CNC(C)C)cc1.COCCc1ccc(OCC(O)CNC(C)C)cc1.O=C(O)CCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Patients receive I-123 MIBG imaging before and after metoprolol succinate.
Eligibility criteria:
Inclusion Criteria:

Essential hypertension with blood pressure less than 140/90 on either an ACE inhibitor or angiotensin receptor blocker

Exclusion Criteria:

Known valvular heart disease of more than mild severity
Known coronary artery disease defined by an angiographic coronary artery stenosis greater than or equal to 50% luminal diameter narrowing, acute or previous myocardial infarction, or previous coronary revascularization
Known non-ischemic cardiomyopathy with left ventricular ejection fraction less than 50%
Atrial fibrillation
Current treatment with a β-adrenergic blocking drug or a calcium channel blocker
Current treatment with a psychoactive or other drug known to alter 123I-MIBG uptake
Participation in another research study within the prior 30 days
A life-limiting disease process that is likely to preclude completion of study participation
Pregnancy or breast feeding
Inability or unwillingness to provide informed consent
Baseline resting heart rate less than 65 beats per minute
Diabetes
Iodine allergy
Unwilling to sign informed consent.
Intervention: Atorvastatin
Trial phase: Phase 1
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: Atorvastatin 40 or 80 mg
Eligibility criteria:
Inclusion Criteria:

Male and female subjects age 21-99 years old.
Peripheral Arterial Disease. PAD is defined clinically and by angiography, magnetic resonance imaging, vascular ultrasound, or ankle brachial index less than 0.9.
Able to provide informed consent and complete the study procedure.
Patients undergoing non-emergent vascular surgery (peripheral arterial bypass, abdominal aortic aneurysm repair, carotid endarterectomy, or limb amputation) or other non-cardiac surgery.

Exclusion Criteria:

Emergent or urgent surgery that must be performed sooner than one week after enrollment
Unstable angina, myocardial infarction, stroke, coronary revascularization, or decompensated heart failure within 1 month of enrollment. Patients who require cardiac catheterization and surgical or percutaneous coronary revascularization prior to vascular surgery will be excluded.
Clinically evident major illness of other organ systems, including cancer, end-stage renal disease, hepatic failure, or other conditions that make participation inappropriate.
Women who are lactating, pregnant, or of childbearing potential and not using a reliable contraceptive method. Pregnancy will be excluded by a urine pregnancy test.
Patients with liver function tests or serum creatine kinase >3 times the upper limit of normal.
Patients who have received an investigational drug within 30 days of enrollment.
Patients or subjects with a history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
Known occlusive atherosclerosis of the subclavian artery or upper extremity, because such disease will interfere with induction of reactive hyperemia during the brachial artery ultrasound studies.
Patients will be excluded if they are taking vitamin C in a dose greater than 2 times the Recommended Daily Allowance (>120 mg/day) within 1 month of enrollment.
Intervention: ASCORBIC ACID
Trial phase: Phase 1
ATC code: A11GA01 | A11GB01 | B03AA10 | G01AD03 | S01XA15
SMILES: O=C1OC(C(O)CO)C(O)=C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: Ascorbi acid 500 mg [per day
Eligibility criteria:
Inclusion Criteria:

Male and female subjects age 21-99 years old.
Peripheral Arterial Disease. PAD is defined clinically and by angiography, magnetic resonance imaging, vascular ultrasound, or ankle brachial index less than 0.9.
Able to provide informed consent and complete the study procedure.
Patients undergoing non-emergent vascular surgery (peripheral arterial bypass, abdominal aortic aneurysm repair, carotid endarterectomy, or limb amputation) or other non-cardiac surgery.

Exclusion Criteria:

Emergent or urgent surgery that must be performed sooner than one week after enrollment
Unstable angina, myocardial infarction, stroke, coronary revascularization, or decompensated heart failure within 1 month of enrollment. Patients who require cardiac catheterization and surgical or percutaneous coronary revascularization prior to vascular surgery will be excluded.
Clinically evident major illness of other organ systems, including cancer, end-stage renal disease, hepatic failure, or other conditions that make participation inappropriate.
Women who are lactating, pregnant, or of childbearing potential and not using a reliable contraceptive method. Pregnancy will be excluded by a urine pregnancy test.
Patients with liver function tests or serum creatine kinase >3 times the upper limit of normal.
Patients who have received an investigational drug within 30 days of enrollment.
Patients or subjects with a history of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
Known occlusive atherosclerosis of the subclavian artery or upper extremity, because such disease will interfere with induction of reactive hyperemia during the brachial artery ultrasound studies.
Patients will be excluded if they are taking vitamin C in a dose greater than 2 times the Recommended Daily Allowance (>120 mg/day) within 1 month of enrollment.
Intervention: Moxifloxacin
Trial phase: Phase 3
ATC code: J01MA14 | S01AE07
SMILES: [H][C@@]12CCCN[C@]1([H])CN(c1c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c1OC)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 251
Group description: Moxifloxacin 400mg once daily for 5 days
Eligibility criteria:
Inclusion Criteria:

Subjects must meet all the following criteria at the time of enrollment:

Age >/= 18 years

Clinical diagnosis of acute bacterial sinusitis with signs and symptoms present for = 7 days but < 28 days as defined by A), radiographic, and B) clinical criteria, as follows:

Radiographic Criteria: The presence of one or more of the following on a radiographic paranasal sinus film (Waters' view): - Evidence of air-fluid levels - Opacification

Clinical Criteria: The presence of two major symptoms, or the presence of at least one major and one minor symptom as defined in the list below:

Major symptoms: - Purulent anterior or posterior nasal discharge - Unilateral facial pain or malar tenderness
Minor symptoms: - Frontal headache - Fever (oral = 38.0°C/100.4°F, tympanic = 38.5°C/101.2°F, axillary = 37.5°C/99.5°F) - Culture material obtained by sinus puncture; the aspirated specimen sent for Gram stain, quantitative culture and susceptibility testing prior to initiation of antimicrobial therapy

Exclusion Criteria:

Subjects with one or more of the following criteria will not be eligible for this study:

History of chronic sinusitis defined as greater than four weeks of continuous symptoms (subjects with recurrent acute sinusitis will be included)
History of sinus surgery (antral sinus puncture is not considered as a surgery)
Any symptoms that suggest the subject's current illness is allergic rhinitis (e.g. repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis
Known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses
Intervention: Rasagiline
Trial phase: Phase 4
ATC code: N04BD02
SMILES: C#CCN[C@@H]1CCc2ccccc21
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Treatment with Rasagiline
Eligibility criteria:
Inclusion Criteria:

Subjects will meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
Current treatment with one or more second generation antipsychotics, except ziprasidone
On same second generation antipsychotic(s)for at least 56 days
On same dose of second generation antipsychotic(s)for at least 30 days
22-item SANS: Total score (i.e.all items minus global items and poverty of content of speech)greater than 20 or global Rating of Affective Flattening greater than or equal to 3 or global Rating of alogia greater than or equal to 3
BPRS: Sum of the four positive symptom items less than or equal to 16 (items 4,11,12,15)
BPRS: Sum of the four Anxiety/Depression Factor items less than or equal to 14 (items 1,2,5,9)
Simpson-Angus Scale: Total score less than or equal to 8

Exclusion Criteria:

DSM-IV Major Depressive Disorder within last 6 months
Current treatment with ziprasidone
DSM-IV diagnosis of alcohol or substance dependence within the last 6 months
DSM-IV criteria for alcohol or substance abuse within the last month
evidence of illicit substance use, as identified with urine toxicology screen
History of an organic brain disorder, mental retardation,epilepsy, or a medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol. See those listed below
Uncontrolled hypertension defined as BP exceeding 145/90 on 3 consecutive readings despite adequate treatment, pheochromocytoma, melanoma, hepatic insufficiency
Pregnancy or lactation in females
Pheochromocytoma
Melanoma
Hepatic insufficiency
Intervention: Varenicline
Trial phase: Phase 4
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 91
Group description: Varenicline
Eligibility criteria:
Inclusion Criteria:

Age 18-60
DSM-IV Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder
Clinically stable with no change in antipsychotic medications and increase of daily dose for 4 weeks prior to enrollment
Sufficient understanding of the study and risks (ESC score 10 or above)

Exclusion Criteria:

Major medical illness history including, but not limited to, history of heart attack, stroke, TIA (transient ischemic attack)
History of organic brain disorders that may affect neurophysiological measurements, including seizure disorder, brain tumor, head injury with evidence of significant cognitive deterioration
DSM-IV diagnosis of substance dependence within 6 months except nicotine and marijuana
On nicotine replacement therapy (nicotine patch, gum, or nasal spray)
Uncontrolled blood pressure (persistent systolic above 155 or diastolic above 95)
EKG of second or third degree atrioventricular (AV) block
Renal insufficiency with estimated creatinine clearance <40 ml/min
Women who have positive urine pregnancy tests
Women who are pregnant, plan to become pregnant, or in breastfeeding
Intervention: Cyclophosphamide
Trial phase: Phase 2
ATC code: L01AA01
SMILES: O=P1(N(CCCl)CCCl)NCCCO1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Treatment with cyclophosphamide 50 mg/kg/d x 2 days.
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically confirmed acute graft-versus-host disease (GVHD) ≥ clinical grade II, that is steroid refractory

Steroid refractory GVHD is defined as GVHD that has progressed (increasing in grading) despite 49 hours of treatment with methylprednisolone of ≥ 2.0 mg/kg OR GVHD that has failed to improve (no change in grading stage) despite 4 days of treatment with methylprednisolone of ≥ 2.0 mg/kg
Prior allogeneic hematopoietic stem cell transplantation using either bone marrow, peripheral blood stem cells, or cord blood OR prior donor lymphocyte infusion required
Evidence of myeloid engraftment
No chronic GVHD

PATIENT CHARACTERISTICS:

ECOG (Eastern Cooperative Oncology Group) performance status (PS) 0-2 OR Karnofsky PS 60-100%
ANC (absolute neutrophil count) > 500/mm³
Not pregnant or nursing
Fertile patients must use effective contraception
Must be geographically accessible
No allergy or intolerance to cyclophosphamide or mesna
No HIV positivity
No mechanical ventilation
No active bleeding (excluding gastrointestinal bleeding) or history of hemorrhagic cystitis

No other uncontrolled illness including, but not limited to, the following:

Ongoing or active infection
Medical condition precluding patient from stopping azoles (e.g., fluconazole, itraconazole, or voriconazole) or other adequate antifungal therapy during cyclophosphamide administration
Symptomatic congestive heart failure
Unstable angina pectoris
Psychiatric illness/social situations that would preclude compliance

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
Intervention: Cyclophosphamide
Trial phase: Phase 2
ATC code: L01AA01
SMILES: O=P1(N(CCCl)CCCl)NCCCO1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Treatment with cyclophosphamide 50 mg/kg/d x 3 days.
Eligibility criteria:
DISEASE CHARACTERISTICS:

Histologically confirmed acute graft-versus-host disease (GVHD) ≥ clinical grade II, that is steroid refractory

Steroid refractory GVHD is defined as GVHD that has progressed (increasing in grading) despite 49 hours of treatment with methylprednisolone of ≥ 2.0 mg/kg OR GVHD that has failed to improve (no change in grading stage) despite 4 days of treatment with methylprednisolone of ≥ 2.0 mg/kg
Prior allogeneic hematopoietic stem cell transplantation using either bone marrow, peripheral blood stem cells, or cord blood OR prior donor lymphocyte infusion required
Evidence of myeloid engraftment
No chronic GVHD

PATIENT CHARACTERISTICS:

ECOG (Eastern Cooperative Oncology Group) performance status (PS) 0-2 OR Karnofsky PS 60-100%
ANC (absolute neutrophil count) > 500/mm³
Not pregnant or nursing
Fertile patients must use effective contraception
Must be geographically accessible
No allergy or intolerance to cyclophosphamide or mesna
No HIV positivity
No mechanical ventilation
No active bleeding (excluding gastrointestinal bleeding) or history of hemorrhagic cystitis

No other uncontrolled illness including, but not limited to, the following:

Ongoing or active infection
Medical condition precluding patient from stopping azoles (e.g., fluconazole, itraconazole, or voriconazole) or other adequate antifungal therapy during cyclophosphamide administration
Symptomatic congestive heart failure
Unstable angina pectoris
Psychiatric illness/social situations that would preclude compliance

PRIOR CONCURRENT THERAPY:

See Disease Characteristics