anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Fingolimod
Trial phase: Phase 2
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.
Eligibility criteria:
Inclusion Criteria:

Patients who completed 6 months of treatment with the study drug and the Month 6 visit in the core study NCT00537082.
Females of childbearing potential who have a negative pregnancy test in the core study NCT00537082.

Exclusion Criteria:

Patients who permanently discontinued study drug treatment prior to the Month 6 visit in the core study NCT00537082.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Intervention: Fingolimod
Trial phase: Phase 2
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.
Eligibility criteria:
Inclusion Criteria:

Patients who completed 6 months of treatment with the study drug and the Month 6 visit in the core study NCT00537082.
Females of childbearing potential who have a negative pregnancy test in the core study NCT00537082.

Exclusion Criteria:

Patients who permanently discontinued study drug treatment prior to the Month 6 visit in the core study NCT00537082.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Intervention: Fingolimod
Trial phase: Phase 2
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 23
Group description: Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
Eligibility criteria:
Inclusion Criteria:

Patients who completed 6 months of treatment with the study drug and the Month 6 visit in the core study NCT00537082.
Females of childbearing potential who have a negative pregnancy test in the core study NCT00537082.

Exclusion Criteria:

Patients who permanently discontinued study drug treatment prior to the Month 6 visit in the core study NCT00537082.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Intervention: Fingolimod
Trial phase: Phase 2
ATC code: L04AA27
SMILES: CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.
Eligibility criteria:
Inclusion Criteria:

Patients who completed 6 months of treatment with the study drug and the Month 6 visit in the core study NCT00537082.
Females of childbearing potential who have a negative pregnancy test in the core study NCT00537082.

Exclusion Criteria:

Patients who permanently discontinued study drug treatment prior to the Month 6 visit in the core study NCT00537082.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Intervention: Vortioxetine
Trial phase: Phase 3
ATC code: N06AX26
SMILES: Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 149
Group description: Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
Eligibility criteria:
Inclusion Criteria:

Suffers from a major depressive episode as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria.
The reported duration of the current major depressive episode is at least 3 months.

Exclusion Criteria:

Has 1 or more the following:

Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.
Current or past history of: manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Any Axis II disorder that might compromise the study.
Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale (MADRS) or has made a suicide attempt in the previous 6 months.
The current depressive symptoms of the patient are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
Has received electroconvulsive therapy within 6 months prior to Screening.
Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Intervention: Vortioxetine
Trial phase: Phase 3
ATC code: N06AX26
SMILES: Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 153
Group description: Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.
Eligibility criteria:
Inclusion Criteria:

Suffers from a major depressive episode as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria.
The reported duration of the current major depressive episode is at least 3 months.

Exclusion Criteria:

Has 1 or more the following:

Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.
Current or past history of: manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Any Axis II disorder that might compromise the study.
Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale (MADRS) or has made a suicide attempt in the previous 6 months.
The current depressive symptoms of the patient are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
Has received electroconvulsive therapy within 6 months prior to Screening.
Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Intervention: PIDOLIC ACID
Trial phase: Phase 4
ATC code: A12CC08
SMILES: O=C1CC[C@@H](C(=O)O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 647
Group description: Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics

Opioid based analgesia: Opioid Analgesic agents delivered by:

PCA on demand mode IV injections PRN IM injections PRN Oral PRN
Eligibility criteria:
Inclusion Criteria:

Men and women, >18 years of age;
Scheduled for elective cardiac surgical procedure, including coronary revasculari-zation or valve surgery;
Provision of informed consent

Exclusion Criteria:

Patients with a prior allergic reaction or dependency to morphine, Demerol, Di-laudid, Fentanyl, Marcaine (bupivacaine), lidocaine or Naropin (ropivacaine);
Cardiac transplant patients
Inability to perform follow-up assessments;
Pre-existing infection (pneumonia or surgical site)
Repeat of primary surgery
Intervention: Hydrocortisone
Trial phase: Phase 4
ATC code: A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04
SMILES: [H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 111
Group description: Hydrocortisone

Hydrocortisone: 25 mg/oral one hour prior to extinction task
Eligibility criteria:
Inclusion Criteria:

Veterans and civilians with an age range of 18 to 65 years
Participants must be physically healthy volunteers

Exclusion Criteria:

Individuals who fall outside the age range
Individuals with medical conditions that would interfere with participation
Other criteria
Intervention: Riboflavin
Trial phase: Phase 3
ATC code: A11HA04 | S01XA26
SMILES: Cc1cc2nc3c(=O)[nH]c(=O)nc-3n(C[C@H](O)[C@H](O)[C@H](O)CO)c2cc1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: riboflavin opthalmic solution without UVA irradiation
Eligibility criteria:
Inclusion Criteria:

Diagnosis of ectasia after refractive surgery
Documented ectasia on Pentacam or topography map
BSCVA worse than 20/20
Must complete all study visits

Exclusion Criteria:

History of delayed wound healing
History of corneal melt or corneal dystrophy
Intervention: Imiquimod
Trial phase: Phase 3
ATC code: D06BB10
SMILES: CC(C)Cn1cnc2c(N)nc3ccccc3c21
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 195
Group description: 3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks
Eligibility criteria:
Inclusion Criteria:

In good general health
Diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 warts
Negative pregnancy test (for women who are able to become pregnant)

Exclusion Criteria:

Women who are pregnant, lactating or planning to become pregnant during the study
Evidence of clinically significant or unstable disease (such as stroke, heart attack)
Have any of the following conditions: HIV infection; current or history of high risk HPV infection (e.g., HPV 16, 18, etc.); outbreak of herpes genitalia in the wart areas; internal warts requiring or undergoing treatment; dermatological disease (e.g., psoriasis) or skin condition in the wart areas
Have received specific treatments in the treatment area(s) within the designated time period prior to study treatment initiation.
Intervention: Metformin
Trial phase: Not Applicable
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: Metformin therapy

Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily
Eligibility criteria:
Inclusion Criteria:

The onset of T2DM for less than 10 years prior to the onset of pregnancy by patient history
Treatment with diet or oral hypoglycemic agents prior to pregnancy.
Pregnancies less than 20 weeks of pregnancy. This gestational age was chosen to include those women who initiated prenatal care in the second trimester, but still have the ability to improve their hemoglobin A1C (primary outcome) with medical therapy prior to delivery.
Newly diagnosed diabetes in the first 20 weeks of pregnancy. These women likely have had diabetes prior to the onset of pregnancy. They do not qualify for the diagnosis of gestational diabetes which is typically made after 20 weeks of pregnancy. Diagnosis will be made based on an elevated fasting blood glucose greater than 105 mg/dL, a 50 gram glucola result greater than 200 mg/dL or an abnormal 3 hour glucola test prior to 20 weeks of pregnancy. An abnormal 3-hour glucola test is defined as 2 out of 4 abnormal values.
Hemoglobin A1C <9%

Exclusion Criteria:

Gestational age greater than 20 weeks
Multiple gestations (twins or more gestations)
Type 1 diabetes by patient history
Known fetal chromosomal or structural defects
Contraindications to the use of metformin including renal disease, liver disease, prior myocardial infarction or sepsis.
Those with a hemoglobin A1C greater than 9%.
On insulin at the start of pregnancy
Intervention: Galantamine
Trial phase: Phase 3
ATC code: N06DA04
SMILES: [H][C@]12C[C@@H](O)C=C[C@]13CCN(C)Cc1ccc(OC)c(c13)O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1024
Group description: During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.
Eligibility criteria:
Inclusion Criteria:

Outpatients
diagnosed with mild to moderately-severe, probable or possible AD, established in accordance with the criteria defined by the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease Related Disorders Association or the Diagnostic and Statistical Manual, Fourth Edition
living with or have regular and frequent visits from a responsible caregiver.

Exclusion Criteria:

Neurodegenerative disorders other than AD, such as Parkinson's Disease, Frontotemporal Dementia or Huntington's disease
Any of specified conditions which may contribute to dementia
any of specified coexisting diseases, including significant cardiovascular disease.
Intervention: Metformin
Trial phase: Phase 4
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Olanzapine plus metformin: olanzapine plus metformin 500 mg titrated up to but no greater than 2,000 mg based upon fasting blood glucose during study visits over six months.

Metformin: Drug: Metformin 500 mg po daily titrated up to but no greater than 2000 mg based upon fasting blood glucose during study visits over six months.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of: Schizophrenia, Schizoaffective Disorder, Bipolar I or II or major depression with psychotic features who will be started on or who have just started taking Olanzapine (Zyprexa).

Exclusion Criteria:

Patients with either a history of diabetes mellitus or a baseline FBG>126 or two random blood sugars of > 200 or during a OGTT glucose level of > 200 two hours after a glucose load of 50 grams. (All American Diabetes Association criteria for diabetes mellitus).
Baseline liver function tests (SGOT, SGPT, AP) greater than 3X normal.
Chronic alcoholism
MDRD less than 60 ml/1.73 m2. Modification of Diet in Renal Disease (MDRD) Equation estimates the glomerular filtration rate as a measure of kidney function. This equation takes into account the plasma creatinine, age, race and gender, and is a more accurate estimation of glomerular filtration rate than serum creatinine alone.
Patients with unstable medical problems, including cardiovascular instability or significant congestive heart failure (as determined by study investigators).
Prolonged QTc greater than 430 ms on baseline EKG.
History of lactic acidosis.
History of hypoglycemia.
Current treatment with metformin or other antidiabetic agents.
Treatment with any antihyperlipidemic medication within 3 months of randomization.
Treatment with olanzapine or clozapine within 3 months of randomization.
Concurrent treatment with ziprasidone, risperidone, quetiapine or aripiprazole or any other neuroleptic medication.
Concurrent use of OTC chromium, gymnema or cimetidine will be prohibited. Patient may discontinue these medications up to one day prior to randomization.
Current treatment with corticosteroids.
Intervention: Metformin
Trial phase: Phase 4
ATC code: A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27
SMILES: CN(C)C(=N)NC(=N)N
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 28
Group description: metformin 2000 mg and birth control pill daily
Eligibility criteria:
Inclusion Criteria:

Ages 18-45, , 8 menstrual cycles annually, elevated serum free testosterone, normal thyroid function test and serum prolactin, exclusion of late onset adrenal hyperplasia

Exclusion Criteria:

Diabetes mellitus, pulmonary, cardiac, renal, hepatic, cholestatic, neurologic, psychiatric, infectious, malignant diseases,history of breast cancer, history of Deep Vein Thrombosis, pregnancy and lactation.
Intervention: Riboflavin
Trial phase: Phase 3
ATC code: A11HA04 | S01XA26
SMILES: Cc1cc2nc3c(=O)[nH]c(=O)nc-3n(C[C@H](O)[C@H](O)[C@H](O)CO)c2cc1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 342
Group description: Topical retapamulin ointment, 1% twice daily for 5 days
Eligibility criteria:
Inclusion criteria:

subject is aged 2 months or older
subject has secondarily-infected traumatic lesion (laceration, sutured wound or abrasion)
negative urine pregnancy test
subject has total skin infection rating scale score of at least 8, including pus/exudate score of at least 3
subject and/or parent/legal guardian is willing and able to comply with protocol
subject or parent/legal guardian has given written informed consent or assent as applicable

Exclusion criteria:

previous hypersensitivity to pleuromutilin
secondarily-infected animal/human bite or puncture wound
subject has an abscess
chronic ulcerative lesion
underlying skin disease
systemic signs and symptoms of infection
infection not appropriately treated with topical antibiotic
infection requires surgical intervention prior to or during study
subject received systemic antibacterial or steroid, or topical therapeutic agent within 24 hours of entry into study
serious underlying disease
subject pregnant, breast feeding or planning a pregnancy, or unacceptable method of contraception
other investigational drug within 30 days of study entry
subject previously enrolled in this study
Intervention: Topiramate
Trial phase: Phase 2
ATC code: A08AA51 | N03AX11
SMILES: [H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H]
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Topiramate and random reinforcement irrespective of cocaine use

topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
Eligibility criteria:
Inclusion Criteria:

18 - 55 years old
active opioid and cocaine dependence
seeking treatment for cocaine and opioid dependence
eligible for methadone maintenance per state and federal regulations
able and willing to provide a urine sample thrice a week
willing to answer questionnaires on a weekly basis
willing to provide breath samples for presence of alcohol thrice weekly
fluent in the English language

Exclusion Criteria:

allergy to sulfonamide drugs
diabetes, respiratory insufficiency, renal tubular acidosis, renal insufficiency, heart failure, liver insufficiency, chronic diarrhea, other chronic diseases predisposing to a risk of acidosis
history of nephrolithiasis
HIV positive individuals who meet AIDS criteria by CDC criteria or are taking antiretroviral medications
serious psychiatric illness (psychosis, dementia)
glaucoma or family history of glaucoma
prostate hyperplasia, shy bladder, irritable bladder, difficulty providing urine samples on demand
female participants: being pregnant, lactating, or unwilling to use an effective method of contraception
use of antiepileptic agents
benzodiazepine dependence
latex allergy
Intervention: Fentanyl
Trial phase: Phase 1 | Phase 2
ATC code: N01AH01 | N01AH51 | N02AB03
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 60
Group description: Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet
Eligibility criteria:
INCLUSION:

18-60 years of age
Present to ED with a chief complaint of extremity injury
Negative pregnancy test (urine or blood)
Clinician judges subject to need extremity radiography to rule out a fracture
Subjects must indicate that their pain is of sufficient severity to warrant treatment with a pain medication stronger than acetaminophen or aspirin.
Subject's treating ED provider is aware of, and approves, participation (i.e. participation cannot be allowed to impair provision of standard patient care).

EXCLUSION:

Treating provider judges that IV analgesia is required
Allergy to acetaminophen or to any opiate/opioid
Currently taking phenothiazines or CNS depressants (including alcohol), or if subject has taken MAO inhibitors or SSRIs within the past two weeks
Already taken or been administered opioid analgesia for their current injury
Chronic opioid therapy or if the subject (or their medical records) indicate a history of opioid abuse
Breastfeeding mothers
If subject is planning to drive home after their ED visit, or if they are judged for any other reason to be non-candidates for opioid therapy.
hypersensitivity to lansoprazole
phenylketonuria
Intervention: Latanoprost
Trial phase: Phase 3
ATC code: S01EE01 | S01EE51
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 363
Group description: One drop self-administered in the study eye(s) once daily for 90 days
Eligibility criteria:
Inclusion Criteria:

18 years or older.
Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol.
Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1.
Willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study, including artificial tears.
Best corrected visual acuity of -0.6 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article.
Use of contact lenses within 30 days of Visit 1.
Use of contact lenses during the study.
Participation in an investigational drug or device study within 30 days of entering this study.
Other protocol-defined exclusion criteria may apply.