anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cariprazine
Trial phase: Phase 2
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 146
Group description: Participants received cariprazine 0.5 mg orally once on Days 1-2, cariprazine 0.75 mg orally once on Days 3-4, cariprazine 1.0 mg orally once on Days 5-7, cariprazine 1.5 mg orally on Days 8-14, and cariprazine 3.0 mg orally once a day starting on Day 15 for the remainder of the 8 week treatment period.
Eligibility criteria:
Inclusion Criteria:

Participants who have provided informed consent prior to any study specific procedures.
Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder as confirmed by the Structured Clinical Interview (SCID) with a current with a current major depressive episode of at least 4 weeks and not exceeding 12 months in duration.
Participants with normal physical examination, laboratory, vital signs, and/or echocardiogram (ECG).
Verified previous manic or mixed episode.
Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.
Participants with a HAMD-17 item 1 score ≥ 2.
Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.

Exclusion Criteria:

Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I disorder that was the primary focus of treatment within the previous 6 months.
Women who are pregnant or breast feeding
Participants with Young Mania Rating Scale (YMRS) total score > 10
Participants who have dementia, mental retardation, schizophrenia/schizoaffective disorder.
Intervention: Cenobamate
Trial phase: Phase 2
ATC code: N03AX25
SMILES: NC(=O)O[C@@H](Cn1ncnn1)c1ccccc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 113
Group description: YKP3089: Capsule, dose to be titrated to a target dose of 200mg/day
Eligibility criteria:
Inclusion Criteria:

Diagnosis of treatment resistant partial epilepsy;
History of epilepsy for at least 2 years;
Have at least 3 simple partial with motor component, complex partial or secondarily generalized seizures per month with no consecutive 21 day seizure free period.

Currently treated on a stable dose of :

1 - 3 AED's for at least 12 weeks prior to randomization.
VNS will not be counted as AED; however the parameters must remain stable for at least 4 weeks prior to baseline.
Benzodiazepines taken at least once per week for epilepsy, or for anxiety or sleep disorder, will be counted as 1 AED. Therefore only a maximum of two additional approved AEDs will be allowed.

Exclusion Criteria:

A history of alcoholism, drug abuse, or drug addiction within the past 2 years.
Subject has had status epilepticus within past 1 year.
Subject has had greater than 2 allergic reactions to an AED or one serious hypersensitivity reaction to an AED.
Subjects taking felbamate with less than 18 months continuous exposure.
Subjects receiving phenytoin, phenobarbitone or metabolites of these drugs.
No active suicidal plan/intent or active suicidal thoughts in the past 6 months.
History of suicide attempt in the last 2 years; not more than 1 lifetime suicide attempt.
Subject meets criteria for current major depressive episode (within 6 months).
Use of intermittent rescue benzodiazepines more than once/month (1-2 doses in a 24-hour period is considered one rescue) in the one month period prior to Visit 1.
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: 44
Group description: Levetiracetam dose was be adjusted at the investigator's discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
Eligibility criteria:
Inclusion Criteria:

The subject in Japan has completed either of the studies N01159 or N01363 or has discontinued the N01159 study due to lack of efficacy.
The subject who is judged to benefit from continued treatment with Levetiracetam by the investigators

Exclusion Criteria:

Subjects with multiple protocol deviations during N01159 or N01363, such as missing laboratory data, and low or noncompliance with the study medication, and who the investigator considers not to have the potential to have deviations stopped are ineligible
Intervention: Asenapine
Trial phase: Phase 4
ATC code: N05AH05
SMILES: CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 120
Group description: Asenapine: Asenapine Sublingual Tablet 10mg, single-dose
Eligibility criteria:
Inclusion Criteria:

Patients will be between the ages of 18 and 65
Be acutely agitated as determined by a total score of ≧ 14 on the PANSS-EC and at least one individual item score of ≧ 4
Patients must have the capacity to provide informed consent, and such consent will be obtained prior to participation

Exclusion Criteria:

Patient is knowingly pregnant
Patient is less than 18 or greater than 65 years old
Patient had a past adverse or allergic response to Asenapine
Intervention: Fospropofol
Trial phase: Phase 4
SMILES: CC(C)c1cccc(C(C)C)c1OCOP(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 116
Group description: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.

Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) I, II or III.
Age 18 - 65.
Both male and female.
No significant laboratory abnormalities.

Exclusion Criteria:

Chronic pain patients or patients receiving benzodiazepines or opioids / other analgesics for control of acute pain will be excluded.
Patients with known allergies to any of the study drugs, or to soybean oil or egg lecithin are excluded.
Women with a positive pregnancy test reported from pre-surgical testing or their physician's office or who are breast feeding at the time of surgery.
No emergency patients will be recruited for this study.
Intervention: Prilocaine Hydrochloride
Trial phase: Not Applicable
SMILES: CCCNC(C)C(=O)Nc1ccccc1C.Cl
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 91
Group description: 5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
Eligibility criteria:
Inclusion Criteria:

Patient scheduled to undergo comprehensive dental treatment under general anesthesia at the Koppel Special Care Dentistry Center at Loma Linda University School of Dentistry
ASA I or II health status
Age greater than 3 years but less than 6 years
Weigh between 10kg and 25kg

Exclusion Criteria:

Patient not requiring restorative dental treatment
Have a BMI less than the 5th percentile or greater than the 95th percentile for their age and gender
Intervention: Cycloserine
Trial phase: Phase 3
ATC code: J04AB01
SMILES: N[C@@H]1CONC1=O
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 142
Group description: This study arm involves the subject receiving 10 sessions of cognitive behavioral therapy with d-cycloserine taken 1 hour before the session.

Cognitive-behavioral therapy: All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.

d-cycloserine: D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg).
Eligibility criteria:
Inclusion Criteria:

Outpatient youth with obsessive-compulsive disorder between the ages 7-17 years.
A Children's Yale-Brown Obsessive-Compulsive Scale score ≥ 16
Child has a Full Scale IQ≥85 as assessed on the WASI (within 90% CI).
English speaking

Exclusion Criteria:

Receiving concurrent psychotherapy or a past adequate trial of CBT for OCD. Families will have the option of discontinuing such services to enroll in the study.
New Treatments: Initiation of an antidepressant within 12 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment. No new alternative medications, nutritionals or therapeutic diets within 6 weeks of study enrollment.
Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxioloytics, stimulant, alpha agonist) within 8 weeks before study enrollment (6 weeks for antipsychotic). Alternative medications must be stable for 6 weeks prior to baseline.
Current clinically significant suicidality or individuals who have engaged in suicidal behaviors within 6 months will be excluded.
DSM-IV conduct disorder, autism, bipolar, schizophrenia or schizoaffective disorders; or substance abuse in past 6 months using all available information.
Youth with hoarding symptoms that are their primary form of OCD.
Weight less than 25.0 kg.
Epilepsy, renal insufficiency, and current/past history of alcohol abuse.
Pregnant or having unprotected sex [in females] as the effects of d-cycloserine on pregnancy are unknown.
Presence of a significant and/or unstable medical illness that might lead to hospitalization during the study.
Known d-cycloserine allergy.
Intervention: Cariprazine
Trial phase: Phase 3
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 765
Group description: Participants received 3, 6, or 9 mg cariprazine orally once a day for 6 weeks; the dose could be modified during this time. The cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this 20 week Open-label Phase.
Eligibility criteria:
Inclusion Criteria:

Participants who have provided informed consent prior to any study specific procedures.
Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for schizophrenia.
Participants with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).
Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
Positive and Negative Syndrome Scale (PANSS) total score ≥ to 70 and ≤ 120 at Visit 1 (Screening) and Visit 2 (beginning of Run-in Phase).
Negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test (applies to female participants of childbearing potential only).
Body mass index between 18 and 40 kg/m^2, inclusive.

Exclusion Criteria:

Participants currently meeting DSM-IV-TR criteria for schizoaffective disorder, schizophreniform disorder, bipolar I and II and known or suspected borderline or antisocial personality disorder. or other DSM-IV-TR axis II disorders.
Participants in their first episode of psychosis.
Treatment-resistant schizophrenia over the last 2 years.
Positive result from the blood alcohol test or from the urine drug screen for any prohibited medication.
At imminent risk of injuring self or others or causing significant damage to property.
Suicide risk.
Intervention: Cariprazine
Trial phase: Phase 3
ATC code: N05AX15
SMILES: CN(C)C(=O)N[C@H]1CC[C@H](CCN2CCN(c3cccc(Cl)c3Cl)CC2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 101
Group description: Participants received 3, 6, or 9 mg cariprazine orally once a day for 26 to 72 weeks.
Eligibility criteria:
Inclusion Criteria:

Participants who have provided informed consent prior to any study specific procedures.
Participants currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for schizophrenia.
Participants with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).
Diagnosis of schizophrenia for a minimum of 1 year before Visit 1 (Screening).
Positive and Negative Syndrome Scale (PANSS) total score ≥ to 70 and ≤ 120 at Visit 1 (Screening) and Visit 2 (beginning of Run-in Phase).
Negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test (applies to female participants of childbearing potential only).
Body mass index between 18 and 40 kg/m^2, inclusive.

Exclusion Criteria:

Participants currently meeting DSM-IV-TR criteria for schizoaffective disorder, schizophreniform disorder, bipolar I and II and known or suspected borderline or antisocial personality disorder. or other DSM-IV-TR axis II disorders.
Participants in their first episode of psychosis.
Treatment-resistant schizophrenia over the last 2 years.
Positive result from the blood alcohol test or from the urine drug screen for any prohibited medication.
At imminent risk of injuring self or others or causing significant damage to property.
Suicide risk.
Intervention: Azarga
Trial phase: Phase 4
SMILES: CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.CCNC1CN(CCCOC)S(=O)(=O)c2sc(S(N)(=O)=O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
Eligibility criteria:
Inclusion Criteria:

Willing to sign an Informed Consent form.
Clinical diagnosis of ocular hypertension, exfoliative open-angle or pigment dispersion glaucoma in at least one eye (study eye).
Be on a stable IOP lowering regimen within 30 days of Screening Visit.
IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
Willing to discontinue the use of COMBIGAN® prior to receiving the study drug at Visit 1.
IOP of between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 logMAR) or better in each eye.
Willing to follow instructions and able to attend required study visits.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Known history of hypersensitivity to any component of the preparations used in this study.
Presence of primary or secondary glaucoma not listed in inclusion criterion #2.
History of ocular herpes simplex.
Abnormality preventing reliable applanation tonometry.
Corneal dystrophies.
Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months prior to the Screening Visit.
Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
Progressive retinal or optic nerve disease from any cause.
Women of childbearing potential not using reliable means of birth control for at least 1 month prior to the Screening/Baseline Visit.
Pregnant or lactating.
Other protocol-defined exclusion criteria may apply.
Intervention: Lurasidone
Trial phase: Phase 3
ATC code: N05AE05
SMILES: [H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 109
Group description: Lurasidone 20, 40 or 60 mg

Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks
Eligibility criteria:
Inclusion Criteria:

Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
Subject is 18 to 75 years of age, inclusive.
Subject has MDD (diagnosed by DSM-IV-TR, and confirmed by the Structured - Clinical Interview for DSM-IV Disorders - Clinical Trial version [SCID-CT]).

Subject is currently experiencing a major depressive episode (diagnosed by DSM IV TR; at least 2 weeks in duration) AND two or three of the following manic symptoms occurring on most days over at least the last 2 weeks (confirmed by the SCID-CT modified for Study D1050304):

Elevated, expansive mood
Inflated self-esteem or grandiosity
More talkative than usual or pressure to keep talking
Flight of ideas or subjective experience that thoughts are racing
Increase in energy or goal-directed activity (either socially, at work or school, or sexually)
Increased or excessive involvement in activities that have a high potential for painful consequences (e.g., engaging in unrestrained buying sprees, sexual indiscretions, or foolish business investments)
Decreased need for sleep (feeling rested despite sleeping less than usual; to be contrasted from insomnia)

Exclusion Criteria:

Subject has Axis I or Axis II diagnosis other than MDD that has been the primary focus of treatment within the 3 months prior to screening.
Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at screening or baseline visit.
Subject has attempted suicide within the past 3 months.
Subject has a lifetime history of any bipolar I manic or mixed manic episode.
Subject has any abnormal laboratory parameter at screening that indicates a clinically significant medical condition as determined by the Investigator.
Intervention: Misoprostol
Trial phase: Not Applicable
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
Eligibility criteria:
Inclusion Criteria:

Desires IUD placement
18 years old or older
negative pregnancy test
no prior pregnancies beyond 14 6/7 weeks
no pelvic inflammatory disease (PID) in last 3 months
no current cervicitis
no contraindications to IUD insertion (see exclusion criteria below)
willing to follow-up in 6-8 weeks for a standard IUD follow-up visit
Determined by her clinician to be an appropriate candidate for an IUD.

Exclusion Criteria:

Active cervical infection
current pregnancy
prior pregnancy beyond 15 weeks' gestation
uterine anomaly
fibroid uterus
copper allergy/Wilson's disease (for Paragard)
undiagnosed abnormal uterine bleeding
cervical or uterine cancer
allergy to misoprostol (study drug)
Intervention: ESLICARBAZEPINE ACETATE
Trial phase: Phase 3
SMILES: CC(=O)O[C@H]1Cc2ccccc2N(C(N)=O)c2ccccc21
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
Eligibility criteria:
Inclusion Criteria:

Written informed consent form;
Of age 65 years or older;
A documented diagnosis of epilepsy for at least 12 months,
At least 2 partial-onset seizures (including subtypes of simple partial, complex partial and/or partial seizures evolving to secondarily generalised) in the 4 weeks prior to screening;
Currently treated with 1 or 2 AEDs (any except oxcarbazepine) in a stable dosage regimen for at least 4 weeks prior to screening. Vagus nerve stimulation (VNS) is to be considered as an AED (i.e., only one concomitant AED is allowed in patients with VNS);
Willing and able to comply with all trial requirements, in the judgment of the investigator;
At least 2 partial-onset seizures (documented in the diary) per 4 weeks during the 8-week baseline period;
Satisfactorily complied with the study requirements during the baseline period

Exclusion Criteria:

Only simple partial seizures with no motor symptomatology (classified as A2-4) according to the International Classification of Epileptic Seizures);
Primarily generalised seizures;
Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive central nervous system lesion) and progressive dementia;
Occurrence of seizures too close to count accurately;
History of status epileptic or cluster seizures 8i.e. 3 or more seizures within 30 minutes) within the 3 months prior to screening;
Seizures of non-epileptic origin;
Major psychiatric disorders;
History of suicide attempt;
Currently treated with oxcarbazepine;
Previous use of ESL or participation in a clinical study with ESL;
Known hypersensitivity to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine) or to any of the excipients;
Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder, hypo - or hyper thyroidism of any type;
Second or third-degree atrioventricular blockade or any clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator;
Relevant clinical laboratory abnormalities as determined by the investigator (e.g. plasma sodium <130 mmol/L, alanine or aspartate aminotransferases >2.0 times above the upper limit of the range, or white blood cell count <3,000 cells/mm3;
Calculated creatinine values < 30 mL/min at screening;
Any other condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol;
Received an investigational drug (or a medical device) within 3 months of screening or is currently participating in another trial of an investigational drug (or medical device) trial.
Intervention: Lurasidone
Trial phase: Phase 3
ATC code: N05AE05
SMILES: [H][C@@]12C(=O)N(C[C@@H]3CCCC[C@H]3CN3CCN(c4nsc5ccccc45)CC3)C(=O)[C@]1([H])[C@H]1CC[C@@H]2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: Lurasidone 20, 40, or 60 mg/day flexibly dosed

Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed
Eligibility criteria:
Inclusion Criteria:

Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.

Subject has completed 6 weeks of treatment in Study D1050304 (NCT#01421134) or Study D1050305 (NCT#01423240).

Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.

Exclusion Criteria:

Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at baseline (Day 43 in Study D1050304 or D1050305).

Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.