anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 58
Group description: Participants receive transcervical instillation of 5 ml saline 3 minutes prior to transcervical tubal sterilization
Eligibility criteria:
Inclusion Criteria:

Female
Age 18 or older
Good general health, based on the opinion of the investigator
Voluntarily requesting permanent sterilization
Negative pregnancy test
Agree to premedication with ibuprofen and ativan
English speaking, or other language if an interpreter is available to be present at all points of the study procedure.
Willing and able to sign an informed consent
Willing to comply with the terms of the study

Exclusion Criteria:

Significant physical or mental health condition, based on the opinion of the investigator.
Positive pregnancy test
Request for IV/IM sedation prior to the start of the procedure
Refusal of ibuprofen, ativan, or paracervical block
Allergy to any study medication including lidocaine, ibuprofen, ativan, sodium bicarbonate
History of toxic reaction to local anesthetics
Known hepatic disease or liver dysfunction. (Lidocaine is metabolized by the liver.)
Weight less than 100 pounds. [Any patient weighing less than 100 pounds would receive more than the recommended dose for their weight (4.5 mg/kg or 2 mg/lb)].
Current participation in another research study which would interfere with the conduct of this study.
Intervention: Rosiglitazone
Trial phase: Phase 2
ATC code: A10BD03 | A10BD04 | A10BG02
SMILES: CN(CCOc1ccc(CC2SC(=O)NC2=O)cc1)c1ccccn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
Eligibility criteria:
Inclusion Criteria:

Able to comprehend and grant a witnessed, written informed consent
Must be greater than 19 years old
Must be able to swallow a tablet
Female participants must have a negative urine pregnancy test at visit 1 and throughout duration of the study
Must have a history of physician diagnosed asthma
Must have a baseline FEV1 >60% predicted
Must be able to perform pulmonary function testing
Must have methacholine-induced decrease in FEV1 of 20%
Must be capable of withholding medications that may affect the methacholine challenge test
Must be able to withstand a 30 day washout period for all inhaled corticosteroids
Must be able to attend all office visits, 4 weeks apart for 12 weeks. Each visit will last approximately 2-3 hours

Exclusion Criteria:

Age 18 or younger
FEV1 <60% predicted value
History or presence of significant renal, hepatic,neurologic, cardiovascular, hematologic, cerebrovascular, respiratory, endocrine, gastrointestinal, or collagen vascular disorder that in the Investigator's opinion could interfere with the study or require medical attention that would interfere with the study.
History of cancer other than basal cell skin cancer
History of hypoglycemia
Current smokers, greater than 10 pack year history, or patients quitting less than 1 year prior to screening
History within the past year of excessive alcohol intake or drug addiction
History of respiratory infection requiring treatment with an antibiotic within 2 week prior to visit 1
Chronic intermittent use of inhaled, oral, intra-muscular, topical or intravenous corticosteroids within 4 weeks of visit 1
Inability to perform consistent spirometry or nitric oxide exhalation
Treatment with an experimental, non-approved drug, or investigational drug within the past 30 days
Known hypersensitivity to rosiglitazone
History of noncompliance to medical regimens and participants who are considered to be potentially unreliable
Intervention: Modafinil
Trial phase: Phase 4
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of ALS
Ages 18-80
Clinically significant fatigue (4.5+ on Fatigue Severity Scale with duration 3+ months plus impairment in 1+ categories of role function)
Speaks English
Able and willing to give informed consent
Can communicate verbally or with assistive device
Can swallow capsules
Forced vital capacity 50+%

Exclusion Criteria:

Untreated hypothyroidism (TSH > 4.25 UIU/ML)
Untreated and uncontrolled hypertension
Clinically significant anemia (HCT < 33%)
Untreated or under-treated major depressive disorder
Current clinically significant suicidal ideation
Started antidepressant medication for treatment of depression during past 6 weeks
Currently taking psychostimulant medication
History or current psychosis or bipolar disorder
Fecund women not currently using barrier methods of contraception
Intervention: Saxagliptin
Trial phase: Phase 3
ATC code: A10BD10 | A10BD21 | A10BD25 | A10BH03
SMILES: N#CC1CC2CC2N1C(=O)C(N)C12CC3CC(CC(O)(C3)C1)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: Saxagliptin 2.5 mg once daily oral dose
Eligibility criteria:
Inclusion Criteria:

Diagnosed with type 2 diabetes
Documented history of CrCl <50 ml/min within the 3 months prior to enrollment
HbA1c ≥7.0% and ≤11.0%

Exclusion Criteria:

Type 1 diabetes, history of diabetic ketoacidosis or hyposmolar non-ketonic coma
Previous or current treatment with any DPP-IV inhibitor and/or GLP-1 mimetic.
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: 122
Group description: 3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
Eligibility criteria:
Inclusion Criteria:

Provide written informed consent and aged between 18 and 75 years of age.
Meets DSM-IV criteria for a primary diagnosis of schizophrenia.
Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
Able and agrees to remain off prior antipsychotic medication for the duration of study.
Good physical health on the basis of medical history, physical examination, and laboratory screening.
Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion Criteria:

Considered by the investigator to be at imminent risk of suicide or injury to self, others or property.
Any chronic organic disease of the CNS (other than schizophrenia).
Used investigational compound within 30 days.
Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months
Intervention: Isoflurane
Trial phase: Not Applicable
ATC code: N01AB06
SMILES: FC(F)OC(Cl)C(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 58
Group description: Inhaled Anesthesia - isoflurane

Isoflurane: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min).
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of Parkinson's Disease with bilateral deep brain stimulation surgery indicated as treatment

Exclusion Criteria:

Not fluent in English
Intervention: Bexarotene
Trial phase: Phase 2
ATC code: L01XF03 | L01XX25
SMILES: C=C(c1ccc(C(=O)O)cc1)c1cc2c(cc1C)C(C)(C)CCC2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Bexarotene: Bexarotene given orally at a dose of 300mg/m2 until disease progression or unacceptable toxicities experienced by patient
Eligibility criteria:
Inclusion Criteria:

Age >= 18 years
Confirmed diagnosis of AML as proven by bone marrow biopsy
Must have received prior induction therapy with conventional chemotherapy and/or Mylotarg or otherwise not eligible for conventional chemotherapy
ECOG performance status of 0-2
Recovered from toxicities of prior chemotherapy

Exclusion Criteria:

History of pancreatitis
Active alcohol abuse
Taken bexarotene in the past
WBC > 10,000/uL at time of enrollment
Cytotoxic therapy within the past 14 days other than hydrea, low dose cytarabine or low dose Mylotarg
Significant organ disfunction: total bilirubin > 3x ULN, AST or ALT >3 x ULN, creatinine > 3 mg/dL, on blood pressure supporting medications or mechanical ventilation
Active participant in any other investigational treatment study for AML
Life expectancy of less than 1 month
Use of blood growth factors (G-CSF, GM-CSF, Aranesp, erythropoietin, or Neumega) within 1 week prior to treatment initiation
Uncontrolled hyperlipidemia
Known history of HIV
Known active CNS involvement with AML
Women of childbearing potential or active breast feeding
Intervention: Zonisamide
Trial phase: Not Applicable
ATC code: G01AE10 | N03AX15
SMILES: NS(=O)(=O)Cc1noc2ccccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Essential Tremor based on the Tremor Investigational Group criteria for definite or probable Essential Tremor.
Age: 18 years or over.
Willingness and ability to comply with the study requirements and give informed consent.

Exclusion Criteria:

Known history of psychiatric disorder, major depression, dementia, aplastic anemia, or Stevens-Johnson syndrome.
Known alcohol or substance abuse in previous 12 months.
Positive pregnancy test.
Unwillingness to use adequate contraceptive methods if of childbearing potential.
Known allergy to sulfonamides.
Laboratory abnormalities prior to onset of trial.
Intervention: Ropivacaine
Trial phase: Not Applicable
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 26
Group description: Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.

Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine
Eligibility criteria:
Inclusion Criteria:

Age 2 years or younger.
Weight 33 kg or less.
Scheduled for elective inguinal herniorrhaphy or orchiopexy.
American Society of Anesthesiologists Class 1, 2 or 3.

Exclusion Criteria:

Age over 2 years.
Weight over 33 kg.
Allergy to ropivacaine.
Usual contraindications to caudal anesthesia (patient refusal, skeletal or spinal cord anomaly, coagulopathy, infection at insertion site, ongoing bacteremia)
Intervention: Ropivacaine
Trial phase: Not Applicable
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 26
Group description: Group CA (Caudal After-control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.

Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine
Eligibility criteria:
Inclusion Criteria:

Age 2 years or younger.
Weight 33 kg or less.
Scheduled for elective inguinal herniorrhaphy or orchiopexy.
American Society of Anesthesiologists Class 1, 2 or 3.

Exclusion Criteria:

Age over 2 years.
Weight over 33 kg.
Allergy to ropivacaine.
Usual contraindications to caudal anesthesia (patient refusal, skeletal or spinal cord anomaly, coagulopathy, infection at insertion site, ongoing bacteremia)
Intervention: Ropivacaine
Trial phase: Not Applicable
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 26
Group description: Group LIA (Local Infiltration After-control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.

Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site
Eligibility criteria:
Inclusion Criteria:

Age 2 years or younger.
Weight 33 kg or less.
Scheduled for elective inguinal herniorrhaphy or orchiopexy.
American Society of Anesthesiologists Class 1, 2 or 3.

Exclusion Criteria:

Age over 2 years.
Weight over 33 kg.
Allergy to ropivacaine.
Usual contraindications to caudal anesthesia (patient refusal, skeletal or spinal cord anomaly, coagulopathy, infection at insertion site, ongoing bacteremia)
Intervention: Zopiclone
Trial phase: Phase 2
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 146
Group description: SEP-225441 (eszopiclone) total daily dose of 0.9 mg
Eligibility criteria:
Inclusion Criteria:

Male and female subjects must be between 18 and 50 years of age
Subjects must have GAD
Subjects must be in otherwise good general health

Exclusion Criteria:

Subject has a documented history of HIV, hepatitis B or hepatitis C.
Subject has a recent history (within 6 months of study entry) or current diagnosis of Major Depressive Disorder, panic disorder (or 3 or more panic attacks in the past month). Post Traumatic Stress Disorder, body dysmorphic disorder, eating disorder, or other disorder.
Subject has a history or presence of Obsessive-Compulsive Disorder (OCD), any psychotic, bipolar or schizophrenic disorder.
Subject has presence or history of antisocial personality or other severe disorder
Subject has refractory GAD (previously unresponsive to 2 or more adequate courses of SSRI, SNRI, benzodiazepine or non-benzodiazepine treatment for GAD).
Subject has history of seizures, including febrile seizures.
Subject has initiated psychotherapeutic intervention with 30 days; however, continued psychotherapy is allowed if stable and not specifically directed at GAD.
Subject is undergoing or has undergone electroconvulsive therapy.
Subject is a current smoker or has smoked within the last 12 months.
Subject has donated blood within the past 30 days or plans to donate during and within 30 days after study participation.
Intervention: Zopiclone
Trial phase: Phase 2
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 145
Group description: SEP-225441 (eszopiclone) total daily dose of 1.5 mg
Eligibility criteria:
Inclusion Criteria:

Male and female subjects must be between 18 and 50 years of age
Subjects must have GAD
Subjects must be in otherwise good general health

Exclusion Criteria:

Subject has a documented history of HIV, hepatitis B or hepatitis C.
Subject has a recent history (within 6 months of study entry) or current diagnosis of Major Depressive Disorder, panic disorder (or 3 or more panic attacks in the past month). Post Traumatic Stress Disorder, body dysmorphic disorder, eating disorder, or other disorder.
Subject has a history or presence of Obsessive-Compulsive Disorder (OCD), any psychotic, bipolar or schizophrenic disorder.
Subject has presence or history of antisocial personality or other severe disorder
Subject has refractory GAD (previously unresponsive to 2 or more adequate courses of SSRI, SNRI, benzodiazepine or non-benzodiazepine treatment for GAD).
Subject has history of seizures, including febrile seizures.
Subject has initiated psychotherapeutic intervention with 30 days; however, continued psychotherapy is allowed if stable and not specifically directed at GAD.
Subject is undergoing or has undergone electroconvulsive therapy.
Subject is a current smoker or has smoked within the last 12 months.
Subject has donated blood within the past 30 days or plans to donate during and within 30 days after study participation.
Intervention: Lidocaine
Trial phase: Phase 2 | Phase 3
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
Eligibility criteria:
Inclusion Criteria:

age greater than or equal to 18 years
English-speaking
ability and willingness to sign the informed consent
ability and willingness to comply with the terms of the study
voluntary request for pregnancy termination
ultrasound-confirmed singleton intrauterine pregnancy with an estimated gestational age not exceeding 76 days (10 6/7 weeks) from the first day of the preceding menstrual cycle

Exclusion Criteria:

women who require or request sedation
untreated acute cervicitis or pelvic inflammatory disease
contraindications to lidocaine such as allergy to lidocaine, cardiac arrhythmia or heart block, and porphyria
allergic reaction or sensitivity to lorazepam or NSAIDs
chronic NSAID use
history of gastritis or gastric ulcer
acute renal failure or chronic renal disease
chronic liver disease
history of bleeding diathesis
chronic narcotic use
current or past history of illegal drug use (excluding marijuana)
Intervention: Vorapaxar
Trial phase: Phase 3
ATC code: B01AC26
SMILES: [H][C@@]12C[C@H](NC(=O)OCC)CC[C@@]1([H])[C@H](/C=C/c1ccc(-c3cccc(F)c3)cn1)[C@]1([H])[C@@H](C)OC(=O)[C@]1([H])C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 258
Group description: Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
Eligibility criteria:
Inclusion Criteria:

Evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems

Exclusion Criteria:

The study will include participants who meet none of the exclusion criteria for the parent protocol (P04737) and also the following:

history or evidence of age-related macular degeneration on baseline evaluation
history of diabetic macular edema, or evidence of treated diabetic retinopathy on baseline evaluation
history or evidence of other retinal diseases, including retinal injury, on baseline evaluation
history or evidence of retinal surgery, including laser photocoagulation, on baseline evaluation
history or evidence of glaucoma on baseline evaluation
history or evidence of high intraocular pressure of >22 mm Hg on baseline evaluation
evidence of center foveal thickness of >190 µm on baseline OCT examination
presence of vacuoles in the retina on baseline OCT
Intervention: Atomoxetine
Trial phase: Phase 2
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Active drug

atomoxetine : Once daily oral dosing
Eligibility criteria:
Inclusion Criteria:

Seeking treatment for cocaine dependence
Must have used cocaine in the past 30 days

Exclusion Criteria:

Physical dependence on any drug requiring medical management
Any major medical or psychiatric disorder that would be contraindicated for participation
Cardiovascular disease
Seizures or significant head injuries
Currently taking atomoxetine
Pregnant or breast-feeding
Intervention: Phenytoin
Trial phase: Phase 4
ATC code: N03AB02 | N03AB52
SMILES: O=C1NC(=O)C(c2ccccc2)(c2ccccc2)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: This group will receive treatment with Phenytoin.
Eligibility criteria:
Inclusion Criteria:

Subjects with traumatic brain injury
Glasgow Coma Score (GCS) score 3-8(inclusive),or GCS motor score of 5 or less and abnormal admission CT scan showing intracranial pathology
Hemodynamically stable with a systolic BP >90 mm Hg
At least one reactive pupil
A negative pregnancy test in females
Age at least 18 years
Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for research form OR
Subjects with subarachnoid hemorrhage (SAH)
SAH documented by CT scan
Hunt-Hess grade 3-5, inclusive
Hemodynamically stable with a systolic BP> 90 mm Hg
At least one reactive pupil
A negative pregnancy test in females
Age of at least 18 years
Signed informed consent and HIPAA authorization for research form

Exclusion Criteria for enrollment

No venous access
Spinal cord injury
History of or CT confirmation of previous brain injury such as brain tumor, cerebral infarct, or spontaneous intracerebral hemorrhage
Hemodynamically unstable
Suspected anoxic events
Other peripheral trauma likely to result in liver failure
Positive pregnancy test in females
Age less than 18 years of age
Known hypersensitivity to any anticonvulsant
An injury that, in the opinion of the principal investigator, has a high likelihood of death within the first 72 hours.
Any treatment, condition, or injury that contraindicates treatment with LEV (levetiracetam) or phenytoin (PHT).
Inability to obtain signed informed consent or HIPAA authorization for research.
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: 56
Group description: Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Patients must be aged 18 to less than 75 years.
Each patient must be reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must understand the nature of the study and have provided informed consent.
All female patients must test negative for pregnancy.
Females of breast-feeding potential must agree not to breastfeed an infant during the study and for 1 month following the last dose of study drug.
Male patients who are not surgically sterilized must agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
Patients must fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR).
Patients must have experienced, in the opinion of the investigator, at least one previous manic or mixed episode, as defined in the DSM-IV-TR.
Patients must have a current Young Mania Rating Scale (YMRS) Total score =<8.

Exclusion Criteria:

Is investigator site personnel directly affiliated with this study or their immediate families.
Is a Lilly employee.
Has previously completed or withdrawn from this study or any other study investigating olanzapine.
Is pregnant or nursing.
Has a serious, unstable illness such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months.