anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Levetiracetam
Trial phase: Phase 4
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
Eligibility criteria:
Inclusion Criteria:

Men and women age 18-65;
Current DSM-IV BDD or its delusional variant (delusional disorder, somatic type) for at least 3 months;
A minimum total score of 20 on the Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS) (19);
Suitable for treatment in an outpatient setting

Exclusion Criteria:

Unstable medical illness, including renal failure or dialysis;
Myocardial infarction within 6 months;
Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
A need for prn benzodiazepines, another antiepileptic medication, or an anticipated change in the dose of any concomitant medications while receiving treatment with levetiracetam;
Clinically significant suicidality, including a suicide attempt within the past two months;
Lifetime history of DSM-IV dementia, schizophrenia, or any other DSM-IV psychotic disorder that is not attributable to BDD;
Current or recent (past 3 months) DSM-IV substance abuse or dependence;
Initiation of ongoing psychotherapy from a mental health professional within 3 months prior to study baseline;
Ongoing cognitive-behavioral therapy from a mental health professional;
Previous treatment with levetiracetam;
Treatment with investigational medication, depot neuroleptics, or ECT within the past 3 months.
Intervention: Zoledronic acid
Trial phase: Phase 2
ATC code: M05BA08 | M05BB08
SMILES: O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: 3.0-4.0 mg by IV (in the vein), once a month for 6 months
Eligibility criteria:
Inclusion Criteria:

invasive lung cancer (small cell or non-small cell lung cancer)
osteolytic bone metastasis determined by clinical exam, bone scan/XR
age > 18 years

Exclusion Criteria:

concurrent malignancy with a second primary
renal failure (serum creatinine > 3mg/dl)
pregnancy
active rheumatoid arthritis
intolerance to zoledronic acid
Intervention: Migalastat
Trial phase: Phase 2
ATC code: A16AX14
SMILES: OC[C@H]1NC[C@H](O)[C@@H](O)[C@H]1O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Migalastat 150 mg was administered orally QOD during the 24-week treatment period and then during the optional 24-week extension period.
Eligibility criteria:
Inclusion Criteria:

Males between 18 and 65 years of age (inclusive)
Hemizygous for Fabry disease
Had a confirmed diagnosis of Fabry disease with a documented missense gene mutation (individual or familial)
Had enhanceable enzyme activity based on in vitro tests
Had documented evidence of cardiac and/or renal dysfunction (for example, abnormal electrocardiogram (ECG), left ventricular hypertrophy, renal insufficiency)
Were previously untreated by enzyme replacement therapy (ERT) or substrate depletion for Fabry disease, or if ERT or other specific treatment for Fabry disease was administered, were able to stop ERT for at least 30 weeks.
Were willing to undergo 2 kidney and 3 skin biopsies
Agreed to be sexually abstinent or use a condom with spermicide when engaging in sexual activity during the course of the study and for a period of 30 days following completion of the study
Were willing and able to sign an informed consent form

Exclusion Criteria:

History of significant disease other than Fabry disease (for example, end-stage renal disease; Class III or IV heart disease [per the New York Heart Association classification]; current diagnosis of cancer, except for basal cell carcinoma of the skin; diabetes [unless hemoglobin A1c ≤8]; or neurological disease that would have impaired the participant's ability to participate in the study)
History of organ transplant
Serum creatinine >176 millimole per deciliter on Day -2
Screening 12-lead ECG demonstrating corrected QT interval >450 milliseconds prior to dosing
Taking a medication prohibited by the protocol: Fabrazyme® (agalsidase beta), Replagal™ (agalsidase alfa), Glyset® (miglitol), Zavesca® (miglustat), or any experimental therapy for any indication
Participated in a previous clinical trial in the last 30 days
Any other condition, which, in the opinion of the investigator, would jeopardize the safety of the participant or impact the validity of the study results
Intervention: Salicylhydroxamic Acid
Trial phase: Phase 2
SMILES: O=C(NO)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
Eligibility criteria:
Inclusion Criteria:

Diabetic macular edema with center involvement in at least one eye
Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening
Laser photocoagulation in the study eye can be withheld for at least 3 months after randomization

Exclusion Criteria:

Patients with uncontrolled systemic or ocular diseases
Have any history of any intraocular surgery in the study eye within the past 6 months preceding screening
Conditions that require chronic concomitant therapy with systemic or topical ocular corticosteroids

Other protocol-defined inclusion/exclusion criteria applied to the study.
Intervention: Povidone iodine
Trial phase: Phase 3
SMILES: C=CN1CCCC1=O.II
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 440
Group description: Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
Eligibility criteria:
Inclusion Criteria: Adult patients who are scheduled for a clean-contaminated surgical procedure of the alimentary or respiratory tract will be eligible for participation. A clean-contaminated wound is one that is entered under controlled conditions without unusual contamination.

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Exclusion Criteria: Patients will be excluded form the study if: (1) they are unable or unwilling to give informed consent; (2) the patient is less than 18 years of age; (3) there is evidence of pre-existing infection at or adjacent to the operative site; (4) a break in sterile technique occurs; (5) the patient has a history of allergy to chlorhexidine, alcohol or iodophors.

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Intervention: Glycine
Trial phase: Phase 2 | Phase 3
ATC code: B05CX03
SMILES: NCC(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.

Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or "sprinkles" (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.

Glycine: Glycine 0.4 g/kg bid
Eligibility criteria:
Inclusion Criteria:

meet SIPS criteria for schizophrenia prodrome

Exclusion Criteria:

history of psychosis
Intervention: Levetiracetam
Trial phase: Phase 3
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 130
Group description: Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
Eligibility criteria:
Inclusion Criteria:

Male/female adult subjects (≥ 16 or 18 years)
Diagnosis of epilepsy (all types of seizures may be included)
Subjects who completed N01175 (NCT00175903) trial and benefited from levetiracetam monotherapy

Other inclusion criteria may apply

Exclusion Criteria:

Subjects withdrawn from N01175 (NCT00175903) trial for any reason
Subjects who received treatment other than levetiracetam in N01175 (NCT00175903) trial
Subject requiring add-on antiepileptic treatment
Subjects from countries where levetiracetam is authorized for use as monotherapy in epilepsy treatment
Sexually active woman with childbearing potential who is not using a medically accepted birth control method
Intervention: Zoledronic acid
Trial phase: Phase 2
ATC code: M05BA08 | M05BB08
SMILES: O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Patients who had greater than 4 disseminated tumor cells (DTCs)/mL present following neoadjuvant or adjuvant chemotherapy for early stage breast cancer were treated with 4mg zoledronic acid each month for 24 months.
Eligibility criteria:
Inclusion Criteria

Women > 18 years of age with histologically or cytologically confirmed stage I, II or III breast cancer.
If adjuvant chemotherapy is recommended, it must be completed before study start.

Bone marrow aspirate positive by IC/FC assay

a. Definition of positive: > 4 MM/ml b. Timing of bone marrow aspiration to determine study eligibility: i. If patient is to receive either no adjuvant therapy or hormonal therapy alone, the aspiration may be performed at diagnosis as part of the large MM study at University of California, San Francisco, or following diagnosis if the patient received initial surgery elsewhere. This is also true for patients who have surgery following neoadjuvant therapy for breast cancer.

ii. If the patient is to receive adjuvant chemotherapy, the aspiration will be performed at least three weeks after chemotherapy has been completed.

Adequate renal function as defined by:

a. Creatinine must be < upper limit of normal

Normal liver function tests including total bilirubin, alkaline phosphatase, and aspartate aminotransferase (AST) / serum glutamic-oxaloacetic transaminase (SGOT)
Ability to understand and sign informed consent.
Concomitant hormonal therapy is allowed
Concomitant radiation therapy is allowed
Patients who have had surgery following neoadjuvant chemotherapy or hormonal therapy are eligible to participate in this trial

Exclusion Criteria

History of allergy to bisphosphonates. Acute phase reactions occur in up to 24% of patients and disappear with subsequent dosing. An acute phase reaction does not qualify as an allergic reaction.
History of renal insufficiency. Renal insufficiency is defined by a serum creatinine greater than the upper limit of normal or a creatinine clearance < 50 mL/min due to any underlying cause.
Karnofsky Performance status < 90%.
Any significant medical condition that might interfere with treatment.
Women participating in this study are not allowed to receive other bisphosphonate therapy during the study period, either oral or intravenous.
Patients who are pregnant
Intervention: Caffeinol
Trial phase: Phase 1 | Phase 2
SMILES: Cn1cnc2c1c(=O)n(CO)c(=O)n2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
Eligibility criteria:
Inclusion Criteria:

Age 18-80 years
Clinical presentation of acute ischemic stroke
Computed tomography (CT) scan compatible with acute ischemic stroke.
Time to caffeinol treatment < 240 minutes from stroke onset.
Time to hypothermia initiation < 300 minutes from stroke onset.
Presumed cortical location of stroke (must have at least on sign such as aphasia, neglect, visual field cut)
National Institutes of Health Stroke Scale (NIHSS) > 8 at time of each treatment.
Tissue plasminogen activator (TPA) treated patients must meet all established criteria for TPA.

Exclusion Criteria:

Etiology other than ischemic stroke.
Item 1a on NIHSS > 1
Signs/symptoms of subcortical, brainstem or cerebellar stroke.
Symptoms resolving or NIHSS < 8 at time of each treatment.
NIHSS > 20 if right hemisphere or >25 if left hemisphere
Known alcoholic
Clinical or laboratory evidence of alcohol intoxication.
Historical evidence of exogenous caffeine exposure beyond daily consumption of coffee or soft drinks.
Known hematologic dyscrasias that affect thrombosis.

Comorbid conditions likely to complicate therapy:

End-stage cardiomyopathy
Uncompensated or clinically significant arrhythmia
Myopathy
Liver disease
History of pelvic or abdominal mass likely to compress inferior vena cava.
End-stage AIDS
History of clinically significant gastrointestinal (GI) bleeding
Impaired renal function with creatinine clearance, 50 ml/min
Intracerebral / intraventricular hemorrhage
Systolic blood pressure (SBP) > 210 or < 100; diastolic blood pressure (DBP) > 100 or < 50 mmHg
Severe coagulopathy
Pregnancy
Use of monoamine oxidase inhibitor (MAOI),serotonin-specific reuptake inhibitor (SSRI) or Tricyclic Antidepressants (TCA) within the preceding 2 weeks
Known history of epilepsy.
Intervention: Migalastat
Trial phase: Phase 2
ATC code: A16AX14
SMILES: OC[C@H]1NC[C@H](O)[C@@H](O)[C@H]1O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Migalastat 250 mg was administered orally QOD during the 12-week treatment period and then during the optional 36-week treatment extension period.
Eligibility criteria:
Inclusion Criteria:

Females between 18 and 65 years of age (inclusive)
Heterozygous for Fabry disease
Had a confirmed diagnosis of Fabry disease with a documented missense gene mutation (individual or familial)
Had enhanceable enzyme activity based on in vitro tests
Were naïve to enzyme replacement therapy (ERT) and other therapies, except for palliative therapies for the signs and symptoms of Fabry disease, or stopped ERT for at least 18 weeks
Had end organ dysfunction, even minimal, demonstrated by abnormal electrocardiogram (ECG) or evidence of left ventricular hypertrophy documented by echocardiogram or by cardiac biopsy; or renal insufficiency documented by common clinical assessments such as creatinine and glomerular filtration rate or by renal biopsy; or brain tissue dysfunction as documented by evidence of stroke (clinically or imaging); or peripheral nervous tissue dysfunction documented by complaints of intolerance to heat or cold, decreased vibratory sense and proprioception, decreased ability to perspire, or acroparesthesia.
Were willing to undergo 2 renal and 3 skin biopsies
Agreed to be sexually abstinent or practice an effective method of contraception when engaging in sexual activity during the course of the study and for a period of 30 days following their completion of the study for women of childbearing potential.
Were willing and able to provide written informed consent

Exclusion Criteria:

Pregnant or lactating
History of organ transplant
History of significant disease other than Fabry disease (for example, end-stage renal disease; Class III or IV heart disease [per the New York Heart Association classification]; current diagnosis of cancer, except for basal cell carcinoma of the skin; diabetes [unless hemoglobin A1c ≤8]; or neurological disease that would have impaired the participant's ability to participate in the study)
Serum creatinine >176 micromoles/liter on Day -2
Screening 12-lead ECG demonstrating corrected QT interval >450 milliseconds
Pacemaker or other contraindication for magnetic resonance imaging scanning
Taking a medication prohibited by the protocol: Fabrazyme® (agalsidase beta), Replagal™ (agalsidase alfa), Glyset® (miglitol), Zavesca® (miglustat), or any experimental therapy for any indication
Participated in a previous clinical trial in the last 30 days
Any other condition which, in the opinion of the investigator would jeopardize the safety of the participant or impact the validity of the study results.
Intervention: Memantine Hydrochloride
Trial phase: Phase 3
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 341
Group description: 28mg once daily oral administration for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Ambulatory patients aged >/= 50 years
Diagnostic evidence of probable Alzheimer's disease consistent with criteria from the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
Confirmatory magnetic resonance imaging (MRI) or computed tomographic (CT) scan within the prior 12 months.
Mini-Mental State Examination (MMSE) scores >/= 3 and </= 14 at Screening (Visit 1) and Baseline (Visit 2)
Ongoing daily acetylcholinesterase inhibitor (AChEI) therapy at a stable dose for at least 3 months prior to Screening (Visit 1). It is preferred that patients continue to receive the same AChEI therapy for the duration of the study.

Exclusion Criteria:

Patients with a modified Hachinski Ischemia Score greater than 4 at Screening.
Patients who have taken memantine within one month of Screening (Visit 1)
Patients who have a known hypersensitivity to memantine, neramexane, rimantadine, or amantadine.
Patients whose AChEI therapy is likely to be interrupted or discontinued during the course of the study.
Patients who are receiving therapy with more than one AChEI.
Patients with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of hydrocephalus, stroke, a space-occupying lesion, cerebral infection, or any clinically significant central nervous system disease other than Alzheimer's disease.
Patients with a DSM-IV Axis I disorder other than Alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder.
Patients who, in the clinician's judgement, are likely to be placed in a nursing home within the next 6 months.
Patients who had evidence of other neurological disorders that included, but were not limited to, stroke, Parkinson's disease, seizure disorder, or head injury with loss of consciousness within the prior 5 years
Patients who had dementia that was complicated by other organic disease
Patients who had dementia complicated by the presence of predominant delusions
Intervention: Salicylhydroxamic Acid
Trial phase: Phase 2 | Phase 3
SMILES: O=C(NO)c1ccccc1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: Sham
Eligibility criteria:
Inclusion Criteria:

18 years or older with a diagnosis of chronic intermediate uveitis in at least one eye

Exclusion Criteria:

Uncontrolled systemic disease
Any active ocular infections
Intervention: Salicylhydroxamic Acid
Trial phase: Phase 2
SMILES: O=C(NO)c1ccccc1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 33
Group description: Sham injection

sham injection: sham injection
Eligibility criteria:
Inclusion Criteria:

500-1250 grams birth weight
less than or equal to 32 weeks gestation
less than 2 days of age

Exclusion Criteria:

severe hemorrhagic disease
severe hemolytic disease
DIC
seizures
hypertension
thromboses
receiving erythropoietin
Intervention: Dexmedetomidine
Trial phase: Phase 4
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 142
Group description: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.

Dexmedetomidine: Dexmedetomidine, 0.5-1 µg/kg, will be infused over 20 minutes, immediately followed by an infusion at a rate of 0.2 µg/kg/hr until the end of surgery (For patients in renal failure, the loading dose will be 0.2 µg/kg). The infusion rate will be reduced as necessary to maintain acceptable blood pressure and heart rate. Propofol will be titrated to maintain BIS as close to 45 as clinically practical.
Eligibility criteria:
Inclusion Criteria:

Consenting adult patients (age >50 years) undergoing carotid endarterectomy with general anesthesia.

Exclusion Criteria:

Receiving another alpha 2-adrenoreceptor agonist;
Contraindication to dexmedetomidine, including allergy;
Current hepatic disease (liver function tests > twice upper limit of normal);
Renal insufficiency, as defined by a creatinine > 2.0 mg/dL;
Mentally impairment, including dementia or delirium;
Heart block ;
Sick sinus syndrome;
Atrial fibrillation with a low ventricular response (< 50 bpm);
Absolute or relative hypovolemia;
Prior stroke;
Severe left-ventricular dysfunction
Intervention: Vitamin K
Trial phase: Not Applicable
ATC code: B02BA01
SMILES: CC(=CCC1=C(C)C(=O)c2ccccc2C1=O)CCCC(C)CCCC(C)CCCC(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 42
Group description: 5 day baseline vitamin K

Vitamin K: phylloquinone (vitamin K1) 200 mcg daily

28 day diet low vitamin K

Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days

treatment started day 6, completed day 33

28 day diet high vitamin K

Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month

treatment started day 34, ended day 61
Eligibility criteria:
Inclusion Criteria:

-

Exclusion Criteria:

kidney, GI, or liver disease requiring treatment
prescribed osteoporosis medications in the previous 3 months
use of acid reducers more than twice per week
blood clotting disorder and/or abnormal clotting time
warfarin or anticoagulant use in the previous 12 months
diabetes
smoking
hormone therapy in the previous 3 months
oral contraceptive use in the previous 3 months; pregnancy
strict vegetarian diet