anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Afegostat tartrate
Trial phase: Phase 2
SMILES: O=C(O)C(O)C(O)C(=O)O.OCC1CNCC(O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: For the first 2 weeks, afegostat tartrate was administered orally at a dose of 225 mg QD for 7 consecutive days, followed by no study medication for 7 consecutive days. After 2 weeks, participants then took 225 mg afegostat tartrate QD for 3 consecutive days, followed by no study medication for 4 consecutive days. This 3-days-on/4-days-off treatment regimen was followed for 22 weeks.
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of type 1 Gaucher disease with a known genotype and a documented missense gene mutation in at least 1 of the 2 gene-encoding β-glucosidase (GBA) alleles
Clinically stable
Treatment naïve to ERT and SRT or had not received ERT or SRT in the 12 months before screening
Willing to not initiate ERT or SRT treatment during study participation
Male or female participants, 18 to 74 years old, inclusive
At the screening period (Day -21 to Day -1), participants must have met at least 2 of the following criteria: platelet count of ≤150,000 per microliter, hemoglobin ≤12 grams/deciliter (g/dL) for females and ≤13 g/dL for males, liver volume ≥1.25 multiples of normal (MN), and spleen volume ≥2 MN
All participants of reproductive potential were required to practice an acceptable method of contraception
Provided written informed consent to participate in the study

Exclusion Criteria:

A clinically significant disease other than Gaucher disease, severe complications from Gaucher disease, or serious intercurrent illness that precluded participation in the study in the opinion of the investigator
During the screening period, had any clinically significant findings as deemed by the investigator
Partial or total splenectomy
Documentation of moderate or severe pulmonary hypertension, defined as pulmonary arterial pressure >35 millimeters of mercury (mmHg) or significant Gaucher-related lung disease
History of allergy or sensitivity to the study drug or any excipients, including any prior serious allergic reaction to iminosugars
Pacemaker or other contraindication for magnetic resonance imaging (MRI) scanning
Pregnant or breast-feeding
Current/recent drug or alcohol abuse
Treatment with any investigational product in the last 90 days before study entry
Treatment in the previous 90 days with any drug known to have a well-defined potential for toxicity to a major organ
Presence of symptoms of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
Intervention: Afegostat tartrate
Trial phase: Phase 2
SMILES: O=C(O)C(O)C(O)C(=O)O.OCC1CNCC(O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Afegostat tartrate was administered orally at a dose of 225 mg QD for 7 consecutive days, followed by no study medication for 7 consecutive days. This 7-days-on/7-days-off treatment regimen was followed for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Confirmed diagnosis of type 1 Gaucher disease with a known genotype and a documented missense gene mutation in at least 1 of the 2 gene-encoding β-glucosidase (GBA) alleles
Clinically stable
Treatment naïve to ERT and SRT or had not received ERT or SRT in the 12 months before screening
Willing to not initiate ERT or SRT treatment during study participation
Male or female participants, 18 to 74 years old, inclusive
At the screening period (Day -21 to Day -1), participants must have met at least 2 of the following criteria: platelet count of ≤150,000 per microliter, hemoglobin ≤12 grams/deciliter (g/dL) for females and ≤13 g/dL for males, liver volume ≥1.25 multiples of normal (MN), and spleen volume ≥2 MN
All participants of reproductive potential were required to practice an acceptable method of contraception
Provided written informed consent to participate in the study

Exclusion Criteria:

A clinically significant disease other than Gaucher disease, severe complications from Gaucher disease, or serious intercurrent illness that precluded participation in the study in the opinion of the investigator
During the screening period, had any clinically significant findings as deemed by the investigator
Partial or total splenectomy
Documentation of moderate or severe pulmonary hypertension, defined as pulmonary arterial pressure >35 millimeters of mercury (mmHg) or significant Gaucher-related lung disease
History of allergy or sensitivity to the study drug or any excipients, including any prior serious allergic reaction to iminosugars
Pacemaker or other contraindication for magnetic resonance imaging (MRI) scanning
Pregnant or breast-feeding
Current/recent drug or alcohol abuse
Treatment with any investigational product in the last 90 days before study entry
Treatment in the previous 90 days with any drug known to have a well-defined potential for toxicity to a major organ
Presence of symptoms of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
Intervention: DIMETHYL FUMARATE
Trial phase: Phase 3
ATC code: L04AX07
SMILES: [H]/C(C(=O)OC)=C(/[H])C(=O)OC
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 344
Group description: Participants received two 120 mg BG00012 capsules orally three times daily (TID)
Eligibility criteria:
Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:

Key Inclusion Criteria:

Must have confirmed diagnosis of RRMS according to McDonald criteria #1-4
Must have a baseline EDSS between 0.0 and 5.0, inclusive.
Must have relapsing-remitting disease course.

Key Exclusion Criteria:

Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
Pregnant or nursing women

Note: Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Elocon
Trial phase: Phase 3
ATC code: D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 426
Group description: MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
Eligibility criteria:
Inclusion Criteria:

Must be 12 years of age or older, of either sex and of any race.
Must have at least a 2-year documented history of SAR which exacerbates during the study season.
Must have a positive skin-prick test response to an appropriate seasonal allergen at Screening (Visit 1). Immunoglobulin E (IgE)-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees and/or grasses) must be documented by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes.
Must be clinically symptomatic at the Screening Visit.
Must be clinically symptomatic at the Baseline Visit.
Must be in general good health as confirmed by routine clinical and laboratory testing and electrocardiogram (ECG) results. Clinical laboratory test (complete blood count [CBC], blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator and the sponsor.
Must be free of any clinically significant disease, other than SAR, that would interfere with the study evaluations.

Exclusion Criteria:

A history of anaphylaxis and/or other severe local reaction(s) to skin testing.
A subject with asthma who requires chronic use of inhaled or systemic corticosteroids.
Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
A subject with rhinitis medicamentosa.
A history of allergies to more than two classes of medications or who are allergic to or cannot tolerate nasal sprays.
A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days before the Screening Visit.
A subject who has nasal structural abnormalities, including large nasal polyps and marked septal deviations, which significantly interfere with nasal air flow.
A subject who, in the opinion of the investigator, is dependent on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.
Intervention: Cycloserine
Trial phase: Phase 4
ATC code: J04AB01
SMILES: N[C@@H]1CONC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: 50 mg d-cycloserine
Eligibility criteria:
Inclusion Criteria:

Male or female
Age 18-65 years
Diagnosis of schizophrenia or schizoaffective disorder, depressed type
Stable dose of antipsychotic for at least 4 weeks.
Able to provide informed consent
Able to complete a cognitive battery

Exclusion Criteria:

Current treatment with clozapine
Dementia
Seizure disorder
Unstable medical illness
Active substance abuse
Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.
Intervention: INSULIN DETEMIR
Trial phase: Phase 4
ATC code: A10AE05
SMILES: CCCCCCCCCCCCCC(=O)NCCCC[C@H](NC(=O)[C@@H]1CCCN1C(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](Cc1ccccc1)NC(=O)CNC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H]1CSSC[C@@H](C(=O)N[C@@H](CC(N)=O)C(=O)O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H]2CSSC[C@H](NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)CN)[C@@H](C)CC)C(C)C)C(=O)N[C@@H](CSSC[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc3c[nH]cn3)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@@H](NC(=O)[C@@H](N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](Cc3c[nH]cn3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc3ccc(O)cc3)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N1)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CO)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N2)[C@@H](C)O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 87
Group description: Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes (diagnosed more than 12 months ago)
HbA1c greater than 7.0 and less than 12.0% at screening
Currently on any OAD in more than 3 months ago
BMI (Body Mass Index) less than 35kg/m2

Exclusion Criteria:

Previous treatment with insulin in more than 7 days within the last 3 months
Uncontrolled treated/untreated hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure less than 110mmHg)
Intervention: Temazepam
Trial phase: Phase 4
ATC code: N05CD07
SMILES: CN1C(=O)C(O)N=C(c2ccccc2)c2cc(Cl)ccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: 1 15 mg pill taken orally, nightly, at bedtime.
Eligibility criteria:
Inclusion Criteria:

Insomnia
HIV Seropositive
Stable HIV Disease

Exclusion Criteria:

Other psychiatric illnesses
Unstable HIV disease
Intervention: Dexmedetomidine
Trial phase: Phase 3
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 61
Group description: 1 subjects Group D experienced an adverse event.
Eligibility criteria:
Inclusion Criteria:

ages 2-10 ASA rating of I-III undergoing general anesthesia tonsillectomy with and without adenoidectomy

Exclusion Criteria:

diagnosis of anxiety disorder or chronic pain syndrome chronic disabilities or developmental delays are currently on psychotherapeutic or sedating medication are on chronic pain medication or opiate any known adverse effect to the study drug any known cardiac abnormalities
Intervention: Dexmedetomidine
Trial phase: Phase 3
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization
Eligibility criteria:
Inclusion Criteria:

age is birth to 18 years
> or = 6 kg.
American Society of Anesthesiology (ASA) I, II, or III
undergone prior cardiac transplant, Fontan or has a patent ductus arterious or atrial septal defect.
scheduled for cardiac catheterization

Exclusion Criteria:

subject or family history of malignant hyperthermia
known hepatic disorder determined by history physical exam or laboratory tests
pregnant or lactating female
receiving inotropic agents or has a pacemaker
weighs less than 6 kg.
Intervention: Dexmedetomidine
Trial phase: Phase 3
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 41
Group description: control group

Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization
Eligibility criteria:
Inclusion Criteria:

age is birth to 18 years
> or = 6 kg.
American Society of Anesthesiology (ASA) I, II, or III
undergone prior cardiac transplant, Fontan or has a patent ductus arterious or atrial septal defect.
scheduled for cardiac catheterization

Exclusion Criteria:

subject or family history of malignant hyperthermia
known hepatic disorder determined by history physical exam or laboratory tests
pregnant or lactating female
receiving inotropic agents or has a pacemaker
weighs less than 6 kg.
Intervention: Balsalazide Disodium
Trial phase: Phase 3
SMILES: O=C([O-])CCNC(=O)c1ccc(N=Nc2ccc([O-])c(C(=O)O)c2)cc1.[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 440
Group description: balsalazide disodium tablets,3.3 g BID,
Eligibility criteria:
Inclusion Criteria:

Subject has a documented history of UC and is either in remission or currently presents with mildly to moderately active UC symptoms as determined by the investigator upon subject interview of UC symptoms, (e.g., urgency, bowel frequency, and rectal bleeding). Additionally, the diagnosis of UC must be confirmed by past flexible sigmoidoscopy/colonoscopy which may include colonic mucosal pathological findings on biopsy consistent with UC.
Subject is capable and willing to comply with all study procedures.

Exclusion Criteria:

Subject has a history of allergy or intolerance to aspirin, mesalamine or other salicylates.
Subject has participated in an investigational drug or device study, other than a previous balsalazide disodium tablet trial (i.e., BZUC3002 or BZUC3003), within 30 days of entering the current study.
Subject discontinued from a previous balsalazide disodium tablet study due to study drug-related AE(s), including UC flare or associated symptoms that were perceived by the subject/investigator as being caused by study drug.
Subject has had any prior bowel surgery, except appendectomy and cholecystectomy.
Subject has unstable cardiovascular, coagulopathy, or pulmonary disease.
Regular use of nonsteroidal anti-inflammatory drugs (NSAIDS) except cardioprotective ASA (i.e., less than or equal to 162 mg ASA per day).
Subject has a history of human immunodeficiency virus (HIV) or hepatitis (B and C). Subjects with a history of hepatitis B and C will be eligible provided the screening LFTs are within normal limits.
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: 118
Group description: Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female inpatients 18 to 65 years of age
Meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV) criteria for bipolar I disorder, acute manic or mixed episode

Having a total Young Mania Rating Scale (YMRS) score >= 20 and a score of at least 4 on two of the following YMRS items:

Irritability,
Speech,
Content, and
Disruptive/Aggressive Behavior

Exclusion Criteria:

Patients who exhibit abnormalities on physical examination, have abnormal vital-signs, electrocardiogram (ECG), or clinical laboratory values [such as thyroid-stimulating hormone (TSH)].
Patients with Montgomery-Åsberg Depression Rating Scale (MADRS) total score >= 18 at Visit 2.
Patients experiencing first manic episode.
Patients that have received electroconvulsive therapy (ECT) or a depot neuroleptic in the 3 months prior to Visit 1.
Intervention: AMINOSALICYLIC ACID
Trial phase: Phase 2
ATC code: J04AA01 | J04AA02 | J04AA03
SMILES: Nc1ccc(C(=O)O)c(O)c1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Oral granules administered as (volume equivalent of active product) 50 mg/kg three times daily for two weeks followed by (volume equivalent) 50 mg/kg two times daily for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Age less than 18 years
Crohn's disease predominantly involving the ileum and/or cecum. The diagnosis must have been established by radiography, endoscopy and/or biopsy (at least 2 of the 3 modalities) with at least one confirmatory test having been performed no more than 36 months before entry. The diagnosis must have been confirmed by at least one gastroenterologist.
Harvey Bradshaw Index of at least 7
The onset of the acute flare should have been abrupt, declaring itself over 72 hours, and should have started no more than 4 weeks before study entry. Symptoms relating to the flare should not have diminished or started to improve prior to entry.
Written informed consent

Exclusion Criteria:

Concomitant corticosteroids, budesonide
Corticosteroids within 2 months
Cyclosporine, mycophenolate mofetil or experimental drugs during the last three months
Maintenance infliximab, or infliximab or other biologics in the preceding 3 months
If the severity of the flare has started to decrease spontaneously
Coexisting diagnosis of primary sclerosing cholangitis
Infectious diarrhea
Signs of intestinal obstruction or perforation
New fistulization as part of the acute flare or increased activity in chronic fistula(e) as part of the acute flare
Hypersensitivity to 4-ASA or any components of PASER®
Pregnancy or breast-feeding
Failure of a woman of child-bearing potential to agree to use adequate contraception for the 4 week period of the trial, if sexually active
Severe renal or hepatic disease (i.e., more than 3 times upper limit of normal) or a WBC < 3,000 during the preceding three months
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: 21
Group description: AL-108, 30 mg/day- 3 sprays in each nostril, twice 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.