anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Davunetide
Trial phase: Phase 2
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@@H]1CCCN1C(=O)[C@H](C)NC(=O)[C@@H](N)CC(N)=O)C(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@@H](CCC(N)=O)C(=O)O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 20
Group description: AL-108, 5 mg/day- one spray in each nostril once per day
Eligibility criteria:
Inclusion Criteria:

DSM IV/DSM IV TR diagnosis of schizophrenia
Capable of providing informed consent
Males and Females
Age: 18 and 60
Caucasian or Non Caucasian
Subjects will be treated with one of the following second generation antipsychotics: risperidone, olanzapine, quetiapine, ziprasidone, or aripiprazole for the previous two months, with no change in dose in the last month, and/or with injectable depot antipsychotics (fluphenazine or haloperidol decanoate) with no change in last 3 months.

Subjects will meet the following symptom criteria:

Average Brief Psychiatric Rating Scale (BPRS) item score >3 (mild)
Simpson-Angus Scale total score less than or equal to 6
Calgary Depression Scale total score less than or equal to 10

Subjects will meet the following cognitive performance criteria:

Performance less than the maximum cutoff (in parentheses) for ONE of the following MCCB tests:

Letter-number span (20);
HVLT total (31); and
CPT d-prime (3.47)
Able to complete the baseline MCCB validly as assessed by Chief Neuropsychologist or NP tester
Raw score of 6 or greater on the WTAR

Exclusion Criteria:

Current treatment with oral conventional antipsychotics (e.g. fluphenazine, haloperidol) or clozapine.
Subjects with a DSM-IV diagnosis of alcohol or substance abuse (other than nicotine) within the last month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine) within the last 6 months

Subjects with a history of significant head injury/trauma, as defined by one or more of the following:

Loss of consciousness (LOC) for more than 1 hour
Recurring seizures resulting from the head injury
Clear cognitive sequellae of the injury
Cognitive rehabilitation following the injury
Subjects with a clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, and/or urological disorder (e.g. unstable angina, decompensated congestive heart failure, CNS infection or history of HIV seropositivity), which would pose a risk to the patient if they were to participate in the study or that might confound the results of the study.
Clinically significant abnormalities in physical examination, ECG, or laboratory assessments.
Clinically significant renal disease.
Women who are pregnant or of child-bearing potential, either not surgically-sterile nor using appropriate methods of birth control
Women who are breast-feeding
Prior participation in a clinical trial of investigational medication within 60 days.
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: 76
Group description: Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
Eligibility criteria:
Inclusion Criteria:

age 18 or older
patient presenting to Grady Memorial Hospital's Emergency Department after having a tonic-clonic seizure (primary or secondarily generalized) within the last 4 hours

Cause of seizure for inclusion: reason for seizure is often undetermined at time of presentation to the Emergency Department. The most likely expected causes of a seizure are noncompliance to existing antiepileptic drug regimen, refractory epilepsy with breakthrough seizure, metabolic aberration, alcohol withdrawal, or unknown.

Exclusion Criteria:

non-English speaking
first time seizure
seizures other than tonic-clonic seizure (primary or secondarily generalized)
more than 3 seizures in 24 hours or status epilepticus, pregnant patients by history or by urine pregnancy testing, serious neurologic insult resulting in seizure but where seizure is not the primary reason for admission (e.g. traumatic brain injury with seizure or hemorrhagic stoke would be excluded)
contraindication to IV levetiracetam
received IV phenytoin within 24 hours
known allergy to phenytoin
previously enrolled in the study
Intervention: Iodofiltic acid (123I)
Trial phase: Phase 2
SMILES: CC(CCCCCCCCCCCCc1ccc(I)cc1)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 507
Group description: A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
Eligibility criteria:
Inclusion Criteria:

Provide written informed consent and are willing to comply with protocol requirements
Are 40 years of age or older.
Are being evaluated for possible ACS.
If female, then not of childbearing potential as documented by history or has a negative serum or urine pregnancy test within 4 hours prior to receiving the test drug and agrees to use an acceptable form of birth control.

Exclusion Criteria:

<40 years of age.
Females who are pregnant or lactating.
History of left ventricular ejection fraction (LVEF)=40%.
History of MI.
Acute ST segment elevation on ECG.
Left bundle branch block on ECG.
Known history of significant allergy to x-ray contrast media or iodine/iodides.
Currently or formerly on medication that targets fatty acid uptake or metabolism, eg ranolazine, (Ranexa).
Administered radiopharmaceutical other than rubidium-82 or thallium-201 within 2 days prior to study enrollment.
Underwent cardiac stress testing of any kind within 2 days prior to study enrollment.
Serum creatinine level >2.0 mg per dL.
Received investigational compound and/or medical device within 30 days of admission into this study.
Q-wave abnormalities consistent with previous MI
Intervention: Cycloserine
Trial phase: Phase 3
ATC code: J04AB01
SMILES: N[C@@H]1CONC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 169
Group description: Participants will receive D-cycloserine augmented cognitive behavioral therapy
Eligibility criteria:
Inclusion Criteria:

Meets DSM-IV criteria for generalized social anxiety disorder (GSAD)
Total score of greater than or equal to 60 on the LSAS
Physical examination, electrocardiogram, and laboratory findings without clinically significant abnormalities

Exclusion Criteria:

Lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders, or obsessive-compulsive disorder
Eating disorder within the 6 months prior to study entry
History of organic brain syndrome, mental retardation, or other cognitive dysfunction
Substance or alcohol abuse or dependence (other than nicotine) within the 6 months prior to study entry or inability to refrain from alcohol use during the acute period of study participation
Post-traumatic stress disorder within 6 months prior to study entry; entry of patients with other mood or anxiety disorders will be permitted if the social anxiety disorder is judged to be the predominant disorder
Suicidal thoughts
Taking concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) within 2 weeks of study entry
Significant personality dysfunction
Serious medical illness or instability for which hospitalization may be likely within the next year
Intervention: Pyridostigmine
Trial phase: Phase 2
ATC code: N07AA02
SMILES: CN(C)C(=O)Oc1ccc[n+](C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Patients will be taking oral Pyridostigmine 30mg tid, as well as their usual antiretroviral treatment

Pyridostigmine tablets: Patients will take 30mg tid PO for 12 weeks
Eligibility criteria:
Inclusion Criteria:

HIV-1 infected subjects 18 years of age or older
Receiving HAART for at least two years
At least a viral load determination per year since HAART initiation, all undetectable
Patient's status is Immunological Non Responder (InR), that is, his or her viral load is reduced, but CD4+ cell count has not raised accordingly
Current viral load: undetectable
Patient agrees and signs informed consent

Exclusion Criteria:

Concomitant active infectious or neoplastic disease
History of new AIDS-defining events during HAART
Pregnancy or breast-feeding
Patients who have been subjects of an investigational agent, chemotherapy or radiotherapy within the previous 28 days
Subjects requiring treatment for Tuberculosis
Subjects unable to follow, or comply with the protocol interventions
Subjects receiving immunosuppressive treatment, including corticosteroids
Intervention: Riluzole
Trial phase: Phase 2
ATC code: N07XX02
SMILES: Nc1nc2ccc(OC(F)(F)F)cc2s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment

riluzole: 50 mg PO bid, 12 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) diagnosis of OCD, confirmed by Structured Clinical Interview for DSM-IV (SCID-IV); symptoms of at least 1 year duration
moderate to severe OCD symptoms as measured by a score on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) of 16 or greater
documented failure of an adequate trial of a selective serotonin reuptake inhibitor (SSRI)
agreement to engage in a reliable form of birth control (women only)

Exclusion Criteria:

primary diagnosis of a psychotic disorder
active substance abuse or dependence
unstable medical condition
prior exposure to riluzole
prior psychosurgery
pregnancy, breastfeeding, or intent to become pregnant during study
liver function tests (LFTs) elevated to more than 2x the upper limit of normal
evidence of active liver disease
seizure disorder
active suicidal ideation
Intervention: Ambroxol
Trial phase: Phase 3
ATC code: R02AD05 | R03CC63 | R05CB06
SMILES: Nc1c(Br)cc(Br)cc1CN[C@H]1CC[C@H](O)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 249
Group description: Patients were orally administered Ambroxol lozenges 20 milligram (mg) initially (first lozenges); up to 6 lozenges per day up to two days, maximal dose:120 mg per day
Eligibility criteria:
1. Patients having a sore throat with acute viral pharyngitis. 2. Female and male ambulant patients between the ages of 18 and 65. 3. The throat pain intensity is rated at least severe on the VRS (PI). 4. Written Informed Consent is given by the patient. 5. Compliance by the patient seems guaranteed.

Patients with symptoms of primarily bacterial pharyngitis or bacterial secondary infection (clinical findings; inter alia assessment of exudate).
First indication of symptoms of acute pharyngitis (e.g., sore throat) occurred more than 3 days ago already.
Counting of white blood cell in blood routine examination exceeds 10?109/L.
Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks.
Broncho-motor disorders or concomitant diseases with relatively large quantities of secretion (danger of secretion blockage).
Known hypersensitivity to Ambroxol or to auxiliary substances contained in the tablet.
Previous and/or existing tumour condition.
Pregnancy and/or breast-feeding.
Alcohol, and/or drug abuse.
Simultaneous participation in another clinical trial.
Intervention: Degarelix
Trial phase: Phase 2
ATC code: L02BX02
SMILES: CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Two doses of Degarelix 16 mg on Day 0 and Day 14
Eligibility criteria:
Inclusion Criteria:

Each patient must comply with all of the following inclusion criteria to be allowed to be randomised into the study:

Man, 55 to 75 years of age.
Clinical diagnose of BPH with a prostate volume more than 30 mL, a maximal uroflow of 12 mL/sec or less and an international prostate sympton score (IPSS) of 13 or more at screening.
A prostate specific antigen (PSA) value less than 10 ng/mL and no clinical evidence of adenocarcinoma of the prostate at screening. If a biopsy of the prostate is performed, a period of 6 weeks should be allowed after the biopsy before the patient is enrolled into the study.
Has a baseline testosterone level above 3 ng/mL at screening.

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be included into the study:

Previous surgery of the prostate.
Previous treatment with GnRH agonists or GnRH antagonists.
Treatment with 5-alpha reductase inhibitors, e.g., finasteride (Prosca®)or dutasteride (Avodart®) within the past 12 months before the study.
Treatment with alpha-adrenergic antagonists, e.g., terazosin, doxazosin, tamsulosin, alfuzosin within 2 weeks prior to Screening part II (or Part I, if IPSS is performed at Screening part I).
Treatment with any drug modifying the testosterone level or function within 12 weeks before Screening visit part II (or Part I, if IPSS is performed at Screening part I).
Intervention: Degarelix
Trial phase: Phase 2
ATC code: L02BX02
SMILES: CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: A single dose of Degarelix 32 mg on Day 0
Eligibility criteria:
Inclusion Criteria:

Each patient must comply with all of the following inclusion criteria to be allowed to be randomised into the study:

Man, 55 to 75 years of age.
Clinical diagnose of BPH with a prostate volume more than 30 mL, a maximal uroflow of 12 mL/sec or less and an international prostate sympton score (IPSS) of 13 or more at screening.
A prostate specific antigen (PSA) value less than 10 ng/mL and no clinical evidence of adenocarcinoma of the prostate at screening. If a biopsy of the prostate is performed, a period of 6 weeks should be allowed after the biopsy before the patient is enrolled into the study.
Has a baseline testosterone level above 3 ng/mL at screening.

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be included into the study:

Previous surgery of the prostate.
Previous treatment with GnRH agonists or GnRH antagonists.
Treatment with 5-alpha reductase inhibitors, e.g., finasteride (Prosca®)or dutasteride (Avodart®) within the past 12 months before the study.
Treatment with alpha-adrenergic antagonists, e.g., terazosin, doxazosin, tamsulosin, alfuzosin within 2 weeks prior to Screening part II (or Part I, if IPSS is performed at Screening part I).
Treatment with any drug modifying the testosterone level or function within 12 weeks before Screening visit part II (or Part I, if IPSS is performed at Screening part I).
Intervention: Degarelix
Trial phase: Phase 2
ATC code: L02BX02
SMILES: CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Two doses of Degarelix 32 mg on Day 0 and Day 14
Eligibility criteria:
Inclusion Criteria:

Each patient must comply with all of the following inclusion criteria to be allowed to be randomised into the study:

Man, 55 to 75 years of age.
Clinical diagnose of BPH with a prostate volume more than 30 mL, a maximal uroflow of 12 mL/sec or less and an international prostate sympton score (IPSS) of 13 or more at screening.
A prostate specific antigen (PSA) value less than 10 ng/mL and no clinical evidence of adenocarcinoma of the prostate at screening. If a biopsy of the prostate is performed, a period of 6 weeks should be allowed after the biopsy before the patient is enrolled into the study.
Has a baseline testosterone level above 3 ng/mL at screening.

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be included into the study:

Previous surgery of the prostate.
Previous treatment with GnRH agonists or GnRH antagonists.
Treatment with 5-alpha reductase inhibitors, e.g., finasteride (Prosca®)or dutasteride (Avodart®) within the past 12 months before the study.
Treatment with alpha-adrenergic antagonists, e.g., terazosin, doxazosin, tamsulosin, alfuzosin within 2 weeks prior to Screening part II (or Part I, if IPSS is performed at Screening part I).
Treatment with any drug modifying the testosterone level or function within 12 weeks before Screening visit part II (or Part I, if IPSS is performed at Screening part I).
Intervention: Degarelix
Trial phase: Phase 2
ATC code: L02BX02
SMILES: CC(=O)N[C@H](Cc1ccc2ccccc2c1)C(=O)N[C@H](Cc1ccc(Cl)cc1)C(=O)N[C@H](Cc1cccnc1)C(=O)N[C@@H](CO)C(=O)N[C@@H](Cc1ccc(NC(=O)[C@@H]2CC(=O)NC(=O)N2)cc1)C(=O)N[C@H](Cc1ccc(NC(N)=O)cc1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: A single dose of Degarelix 64 mg on Day 0
Eligibility criteria:
Inclusion Criteria:

Each patient must comply with all of the following inclusion criteria to be allowed to be randomised into the study:

Man, 55 to 75 years of age.
Clinical diagnose of BPH with a prostate volume more than 30 mL, a maximal uroflow of 12 mL/sec or less and an international prostate sympton score (IPSS) of 13 or more at screening.
A prostate specific antigen (PSA) value less than 10 ng/mL and no clinical evidence of adenocarcinoma of the prostate at screening. If a biopsy of the prostate is performed, a period of 6 weeks should be allowed after the biopsy before the patient is enrolled into the study.
Has a baseline testosterone level above 3 ng/mL at screening.

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be included into the study:

Previous surgery of the prostate.
Previous treatment with GnRH agonists or GnRH antagonists.
Treatment with 5-alpha reductase inhibitors, e.g., finasteride (Prosca®)or dutasteride (Avodart®) within the past 12 months before the study.
Treatment with alpha-adrenergic antagonists, e.g., terazosin, doxazosin, tamsulosin, alfuzosin within 2 weeks prior to Screening part II (or Part I, if IPSS is performed at Screening part I).
Treatment with any drug modifying the testosterone level or function within 12 weeks before Screening visit part II (or Part I, if IPSS is performed at Screening part I).
Intervention: Travoprost
Trial phase: Phase 4
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: One drop in the study eye, single dose
Eligibility criteria:
Inclusion Criteria:

18 years of age or older.
Clinical diagnosis of ocular hypertension, primary open-angle, pigment dispersion, or exfoliation glaucoma in both eyes.
Best corrected visual acuity of 20/200 Snellen or better in each eye.
Intraocular pressure within protocol-specified range.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Any abnormality preventing reliable applanation tonometry in the study eye(s).
Any eye conditions or procedures as specified in protocol.
Progressive retinal or optic nerve disease from any cause.
Use of contact lenses in the study eye(s).
Other protocol-defined exclusion criteria may apply.
Intervention: Levetiracetam
Trial phase: Phase 2
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 33
Group description: Intravenous 100 mg/mL, twice a day, maximum of 4 days

Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.

Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily).
Eligibility criteria:
Inclusion Criteria:

Male or female between 4 and 16 years of age, inclusive
The subject suffers from epilepsy (except status epilepticus)
The subject is requiring levetiracetam IV treatment in place of oral therapy for a short period of time

Exclusion Criteria:

The subject has difficult venous accessibility
History of status epilepticus during the 3 months prior to visit 1.
The subject is taking felbamate at visit 1 or has been taking it in the past.
Intervention: Travoprost
Trial phase: Phase 4
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: travoprost 0.004%
Eligibility criteria:
Inclusion Criteria:

Diagnosis of open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are allowed) or ocular hypertension

Exclusion Criteria:

Known contraindication to latanoprost, bimatoprost or travoprost
Uncontrolled systemic disease
Active ocular disease other than glaucoma or ocular hypertension
Pregnant or lactating women or women of childbearing potential NOT utilizing a medically acceptable form of birth control
Intervention: Riluzole
Trial phase: Not Applicable
ATC code: N07XX02
SMILES: Nc1nc2ccc(OC(F)(F)F)cc2s1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Riluzole 100-200 mg/day
Eligibility criteria:
Inclusion Criteria:

Male or female age 18-65
Meets DSM-IV criteria for Bipolar Disorder and is currently depressed
Current score of >/= 18 on the Hamilton Depression Scale

Exclusion Criteria:

Active psychotic/manic symptoms
Lifetime history of schizophrenia or obsessive compulsive disorder
Clinically significant medical disease
Women who are pregnant or lactating and women who are not using a medically accepted method of contraception.