anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cetirizine
Trial phase: Phase 3
ATC code: R06AE07 | R06AE09 | S01GX12
SMILES: O=C(O)COCCN1CCN(C(c2ccccc2)c2ccc(Cl)cc2)CC1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 255
Group description: 0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily.
Eligibility criteria:
Inclusion Criteria:

Inclusion criteria which must be verified during screening visit (V1):

Children of either sex aged between 12 and 24 months
Subjects suffering from symptoms of Atopic Dermatitis (AD) lasting cumulatively for at least 2 months since birth
Modified Severity Scoring of Atopic Dermatitis (SCORAD) Index >= 10
Subjects whose biological mother or father, or one sibling has a well-documented history of atopy (AD, allergic rhinitis or asthma)

Inclusion criteria which must be verified during randomization (V2):

Results of the Radio-allergosorbant (RAST) test for grass pollen (GP) and house dust mite (HDM) are available and Immunoglobulin E (IgE) level against GP >= 0.35 kUA/l and/or IgE level against HDM ≥ 0.35 kUA/l
Safety laboratory results are within the normal range of the central laboratory or considered as not clinically significant or study disease related by the Investigator

Exclusion Criteria:

Exclusion criteria to verify at screening visit (V1):

Are to be excluded from the participation in the study, those children who

Have height or weight below the 5th percentile
Have experienced at least one episode of wheezing when aged 6 months or over
Have suffered at age 6 months or over, from at least one nocturnal cough episode consisting of 3 (or more) consecutive nights resulting in sleep disturbances in a clinical setting where asthma is likely and other conditions have been excluded
Have chronic pulmonary diseases of any type, such as, but not limited to, cystic fibrosis, or any cranio-facial abnormality, e.g., cleft palate
Have a personal history of sleep apnea or who have siblings with a history of sleep apnea
Are treated with any immunomodulator medication such as, e.g., cyclosporin, cyclophosphamide or FK 506 (Tacrolimus)
Have received or are receiving allergen - specific immunotherapy
Suffer from concomitant dermatological disease/condition other than atopic dermatitis, that might interfere with the evaluation of the clinical response for atopic dermatitis

Have an insufficient wash-out period for the following medications:

Intranasal or systemic antihistamines: 3 days,
Intranasal or systemic decongestants: 3 days,
Loratadine, Desloratadine: 10 days,
Chromones: 2 weeks,
Oral corticosteroids: 1 month,
Chronic use (i.e. cumulatively up to 2 weeks within the last 3 months) of inhaled/intranasal corticosteroids: 1 month,
Ketotifen: 1 month,
Astemizole: 6 weeks
Have been treated with any antihistamine, including ketotifen, with daily intake for more than 2 consecutive months in the last 6 months before screening

Subject Exclusion criteria to verify at randomization visit (V2):

• Intake of any prohibited medication listed above during the selection period
Intervention: Erlotinib
Trial phase: Phase 3
ATC code: L01EB02 | L01XE03
SMILES: C#Cc1cccc(Nc2ncnc3cc(OCCOC)c(OCCOC)cc23)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 77
Group description: Tarceva 150mg

Erlotinib (tarceva): Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.
Eligibility criteria:
Inclusion Criteria:

Unresectable, stage IIIA or IIIB NSCLC (measurable disease is not required)
No evidence of metastatic disease
No prior treatment
Adequate organ function
Adequate pulmonary function (FEV >= 1.0L or predicted FEV >0.8L)

Exclusion Criteria:

Metastasis
Prior treatment
Malignant pleural or pericardial effusion
Peripheral neuropathy >= grade 2
Intervention: Acitretin
Trial phase: Phase 2
ATC code: D05BB02
SMILES: COc1cc(C)c(/C=C/C(C)=C/C=C/C(C)=C/C(=O)O)c(C)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: patients on etanercept taking open-label acitretin
Eligibility criteria:
Inclusion Criteria:

Adults (aged 18 to 80 years old) with moderate to severe psoriasis (defined as having a physician global assessment score of 3 [moderate] or higher) who are on etanercept 50 mg SQ once weekly and have not achieved PASI 75 after 12 weeks or more of treatment with etanercept
All patients on etanercept have been tested for TB before initiation of etanercept

Exclusion Criteria:

Patients < 18 years old or > 80 years old
Patients who are not on etanercept 50 mg SQ once weekly
Women of childbearing potential (Note: women of non-childbearing potential, meaning surgically sterile [bilateral oophorectomy, hysterectomy, and/or bilateral tubal ligation] or post-menopausal for at least 2 years, are eligible)
Inability to understand consent or comply with study requirements
Uncontrolled hypertriglyceridemia
Patients with severely impaired hepatic function
Patients without health insurance or who are not willing to pay out-of-pocket for etanercept and laboratory tests
Systemic psoriasis therapies or PUVA within the past 2 weeks
UVB or topical psoriasis therapies (other than emollients/moisturizers and OTC shampoos) within the past 1 week
Patients with epilepsy or multiple sclerosis
Intervention: Zolpidem
Trial phase: Phase 4
ATC code: N05CF02
SMILES: Cc1ccc(-c2nc3ccc(C)cn3c2CC(=O)N(C)C)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 20
Group description: QHS dosing with 10mg of zolpidem
Eligibility criteria:
Inclusion Criteria:

Ages 25 - 55
a stable sleep/wake schedule with a preferred sleep phase between 10:00 p.m. and 8:00 a.m.
Patients with Primary Insomnia will meet diagnostic criteria for Psychophysiologic Insomnia according to the International Classification of Sleep Disorders manual (ICSD).
complaint of disturbed sleep must have the following characteristics: >30 minutes to fall asleep, and/or >30 minutes wake after sleep onset time, a total sleep time of no more than 6.5 hours (or a sleep efficiency of less than 85%), a problem frequency of >4 nights/ week and a problem duration >6 months.

Exclusion Criteria:

Unstable medical or psychiatric illness
Use of medication that may cause insomnia or may be reduce the effectiveness of zolpidem (e.g. selective serotonin reuptake inhibitors(SSRI's), steroids, bronchodilators, calcium channel blockers, beta blockers, etc.)
symptoms suggestive of sleep disorders other than insomnia
polysomnographic data indicating sleep disorders other than insomnia
Evidence of active illicit substance use or fitting criteria for alcohol abuse or dependence
inadequate language comprehension
pregnancy
first-degree relatives with bipolar disorder or schizophrenia
Intervention: Zolpidem
Trial phase: Phase 4
ATC code: N05CF02
SMILES: Cc1ccc(-c2nc3ccc(C)cn3c2CC(=O)N(C)C)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
Eligibility criteria:
Inclusion Criteria:

Ages 25 - 55
a stable sleep/wake schedule with a preferred sleep phase between 10:00 p.m. and 8:00 a.m.
Patients with Primary Insomnia will meet diagnostic criteria for Psychophysiologic Insomnia according to the International Classification of Sleep Disorders manual (ICSD).
complaint of disturbed sleep must have the following characteristics: >30 minutes to fall asleep, and/or >30 minutes wake after sleep onset time, a total sleep time of no more than 6.5 hours (or a sleep efficiency of less than 85%), a problem frequency of >4 nights/ week and a problem duration >6 months.

Exclusion Criteria:

Unstable medical or psychiatric illness
Use of medication that may cause insomnia or may be reduce the effectiveness of zolpidem (e.g. selective serotonin reuptake inhibitors(SSRI's), steroids, bronchodilators, calcium channel blockers, beta blockers, etc.)
symptoms suggestive of sleep disorders other than insomnia
polysomnographic data indicating sleep disorders other than insomnia
Evidence of active illicit substance use or fitting criteria for alcohol abuse or dependence
inadequate language comprehension
pregnancy
first-degree relatives with bipolar disorder or schizophrenia
Intervention: Naltrexone
Trial phase: Phase 3
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
Eligibility criteria:
Primary Inclusion Criteria:

Adults with a diagnosis of alcohol and/or opioid dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) who had satisfactorily completed Alkermes' Study ALK21-006 or other qualifying Medisorb naltrexone study
Willing and able to return for scheduled clinic visits and study assessments
Had a stable address
Agreed to use a contraception for the duration of the study and for 1 month following the last dose if of childbearing potential
Written informed consent

Primary Exclusion Criteria:

Pregnancy or lactation
Terminated early from study drug in a previous Medisorb naltrexone clinical trial
Any finding that, in the view of the investigator, would compromise the ability to fulfill the protocol visit schedule and/or visit requirements
Intervention: Pimozide
Trial phase: Phase 4
ATC code: N05AG02
SMILES: O=c1[nH]c2ccccc2n1C1CCN(CCCC(c2ccc(F)cc2)c2ccc(F)cc2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: Participants received pimozide flexible dosing
Eligibility criteria:
Inclusion Criteria:

Diagnosis of schizophrenia according to DSM-IV criteria
Any schizoaffective disorder or subtype
Score greater than 60 on the Positive and Negative Syndrome Scale (PANSS)
Currently taking clozapine
Score of four or higher on two or more items from the positive symptom subscale of the PANSS
Score of 4 or greater on the Clinical Global Impression (CGI) scale
Clozapine plasma level greater than 378 µg/ml
Stable dose of clozapine demonstrated to have been associated with a clozapine plasma level greater than 378 µg/ml for at least eight weeks
Able to read at an 8th grade level or above

Exclusion Criteria:

History of unstable coronary artery disease
Congestive heart failure
History of long Q-T syndrome
History of cardiac arrhythmia
History of cardiac conduction delay
Baseline QT correction score greater than 0.425 seconds
Liver disease
History of stroke
History of Neuroleptic Malignant Syndrome
Hypokalemia
Hypocalcemia
Current blindness, deafness, language difficulties, or any other disability which may prevent participation or cooperation in the study
Current suicidal or homicidal thoughts
Currently abusing psychoactive substances
Currently receiving antidepressants, thymoleptics, L-DOPA, buspirone, or antipsychotics other than clozapine (Valproic acid and Divalproex sodium are not criteria for exclusion)
Intervention: Citicoline
Trial phase: Phase 2
ATC code: N06BX06
SMILES: C[N+](C)(C)CCOP(=O)([O-])OP(=O)(O)OC[C@H]1O[C@@H](n2ccc(N)nc2=O)[C@H](O)[C@@H]1O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: 2 gm/day

citicoline: 2 gm/day, 8 weeks treatment
Eligibility criteria:
Inclusion Criteria:

Meets DSM-IV criteria for current marijuana dependence
Women with a negative pregnancy test prior to study entry
Heavy smoker, defined as smoking more than 10 joints per week

Exclusion Criteria:

Abnormal electrocardiogram (ECG)
Medical disorder that requires prescription medication
Psychiatric disorder that requires prescription medication
Abnormal liver function tests
Taking herbal preparations
Taking any over-the-counter medications on a chronic basis
Pregnancy or breast feeding
Neurological, infectious, or neoplastic disease
Currently seeking treatment for marijuana abuse
Meets criteria for alcohol, cocaine, or opioid dependence
Intervention: Propranolol
Trial phase: Phase 4
ATC code: C07AA05 | C07BA05 | C07FX01
SMILES: CC(C)NCC(O)COc1cccc2ccccc12
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 43
Group description: Following the occurrence of an acute psychologically traumatic event, an initial dose of short-acting propranolol 40 mg orally then one hour later, long-acting propranolol 60 mg capsule orally on Day 1 followed by a 19-day course of long-acting propranolol starting with 120 mg every morning and evening for 10 days, and then tapering to 120 mg in the morning and 60 mg in the evening for 3 days, then 60 mg in the morning and 60 mg the evening for 3 days, then 60 mg in the morning for 3 days.
Eligibility criteria:
Inclusion Criteria:

Experienced an acute psychological traumatic event
Heart rate of 80 beats per minute (bpm) or greater
Understands English

Exclusion Criteria:

Traumatic event that occurred more than four hours before arrival to emergency department
Physical injury that may affect safe participation (e.g., head injury)
Systolic blood pressure less than 100 mm Hg
Medical or surgical condition that poses a risk of shock
Medical condition that may affect the safe administration of propranolol
Previous adverse reaction to, or non-compliance with, a beta-blocker
Current use of medication that may react badly with propranolol
Elevated saliva alcohol level
Presence of salivary opiates, marijuana, cocaine, or amphetamines
Pregnant or breastfeeding
Traumatic event reflecting ongoing victimization
Psychiatric condition that may affect safe participation
Unwilling or unable to commute to Boston for research visits
Attending physician in emergency department does not advise participation
Intervention: VALACYCLOVIR
Trial phase: Phase 4
ATC code: J05AB11
SMILES: CC(C)[C@H](N)C(=O)OCCOCn1cnc2c(=O)nc(N)[nH]c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 255
Group description: Participants received double blinded treatment of oral dose of Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). Participants with GH recurrences during the study temporarily discontinued their blinded treatment assignment and received open label valaciclovir 500 mg BID for 3 days after which the double-blind therapy was resumed.
Eligibility criteria:
Inclusion criteria:

In overall general good health.
Females can enter and participate in this study if they are of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or if of childbearing potential, has a negative pregnancy test (urine) at screening and agrees to use GSK stipulated contraceptive methods.
Must be newly diagnosed with a first recognized episode of GH at the time of the Screening Visit or within 3 months prior to the Screening Visit.

Exclusion criteria:

Known or suspected to be immunocompromised (e.g., subjects receiving immunosuppressive therapy or chemotherapy for malignancy, or are seropositive for HIV).
Received an investigational drug in the 30 days prior to the study.
Receiving systemic antiviral or immunomodulatory treatments.
Must not have received systemic antiviral treatments (e.g., valaciclovir, Famvir (famciclovir), acyclovir, lysine) within 3 days of starting study drug or immunomodulatory treatments in the 30 days before starting study drug.
Clinically significant impaired renal function as defined by a creatinine clearance <30 ml/min, calculated using the Cockcroft-Gault formula.
Clinically significant impaired hepatic function defined as an ALT (alanine transaminase) level > 5 times the normal upper limit.
Subjects with active liver disease.
Known to be hypersensitive to acyclovir, famciclovir, ganciclovir or any component of valaciclovir formulations.
Known resistance to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir or valganciclovir.
Subjects with malabsorption or vomiting syndrome or other gastrointestinal dysfunction that might impair drug pharmacokinetics.
Women contemplating pregnancy within the duration of the study drug dosing period.
Women who are pregnant and/or nursing mothers
Current history of alcohol or drug abuse.
Received suppressive (daily) therapy for genital herpes prior to enrollment.
Intervention: Formoterol
Trial phase: Not Applicable
ATC code: R03AC13 | R03AK07 | R03AK08 | R03AK09 | R03AK11 | R03AL05 | R03AL07 | R03AL09 | R03AL10 | R03AL11 | R03CC15
SMILES: COc1ccc(CC(C)NCC(O)c2ccc(O)c(NC=O)c2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients who received Formoterol treatment
Eligibility criteria:
Inclusion Criteria:

Patients with mild steroid-naïve asthma (ATS criteria) of either sex with FEV1 >70 % pred
Able to produce sputum after sputum induction
Exhaled NO (flow 50 ml/s) ≥ 20 ppb
Written informed consent

Exclusion Criteria:

Current upper respiratory tract infections
Use of inhaled and/or oral GCS within 4 weeks prior to visit 1
Treatment with antileukotrienes, theophylline, tiotropium and ipratropium within 2 weeks prior to screening visit
Hypersensitivity to any of the investigational drugs or lactose
Use of any beta blocking agent (including eye-drops)
Women who are pregnant, breast-feeding or planning a pregnancy during the study. Women must be postmenopausal (at least one year must have passed after the last menstruation), surgically sterile or using acceptable contraceptives, as judged by the investigator
Any significant disease or disorder (e.g. cardiovascular, pulmonary (other than asthma), gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subjects ability to participate in the study
Inability to tolerate temporary withdrawal of bronchodilatory therapy
Subjects not considered capable, as judged by the investigator, of following instructions of the study, e.g. because of a history of alcohol or drug abuse or any other reason
Previous randomization in this study
Intervention: Budesonide
Trial phase: Not Applicable
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients who received Budesonide low dose treatment
Eligibility criteria:
Inclusion Criteria:

Patients with mild steroid-naïve asthma (ATS criteria) of either sex with FEV1 >70 % pred
Able to produce sputum after sputum induction
Exhaled NO (flow 50 ml/s) ≥ 20 ppb
Written informed consent

Exclusion Criteria:

Current upper respiratory tract infections
Use of inhaled and/or oral GCS within 4 weeks prior to visit 1
Treatment with antileukotrienes, theophylline, tiotropium and ipratropium within 2 weeks prior to screening visit
Hypersensitivity to any of the investigational drugs or lactose
Use of any beta blocking agent (including eye-drops)
Women who are pregnant, breast-feeding or planning a pregnancy during the study. Women must be postmenopausal (at least one year must have passed after the last menstruation), surgically sterile or using acceptable contraceptives, as judged by the investigator
Any significant disease or disorder (e.g. cardiovascular, pulmonary (other than asthma), gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subjects ability to participate in the study
Inability to tolerate temporary withdrawal of bronchodilatory therapy
Subjects not considered capable, as judged by the investigator, of following instructions of the study, e.g. because of a history of alcohol or drug abuse or any other reason
Previous randomization in this study
Intervention: Budesonide
Trial phase: Not Applicable
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Patients who received Budesonide high dose treatment
Eligibility criteria:
Inclusion Criteria:

Patients with mild steroid-naïve asthma (ATS criteria) of either sex with FEV1 >70 % pred
Able to produce sputum after sputum induction
Exhaled NO (flow 50 ml/s) ≥ 20 ppb
Written informed consent

Exclusion Criteria:

Current upper respiratory tract infections
Use of inhaled and/or oral GCS within 4 weeks prior to visit 1
Treatment with antileukotrienes, theophylline, tiotropium and ipratropium within 2 weeks prior to screening visit
Hypersensitivity to any of the investigational drugs or lactose
Use of any beta blocking agent (including eye-drops)
Women who are pregnant, breast-feeding or planning a pregnancy during the study. Women must be postmenopausal (at least one year must have passed after the last menstruation), surgically sterile or using acceptable contraceptives, as judged by the investigator
Any significant disease or disorder (e.g. cardiovascular, pulmonary (other than asthma), gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subjects ability to participate in the study
Inability to tolerate temporary withdrawal of bronchodilatory therapy
Subjects not considered capable, as judged by the investigator, of following instructions of the study, e.g. because of a history of alcohol or drug abuse or any other reason
Previous randomization in this study
Intervention: Olanzapine
Trial phase: Phase 3
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 107
Group description: Olanzapine 5-20 mg once daily for 40 weeks
Eligibility criteria:
Inclusion Criteria:

Have completed asenapine 3-week and 9 -week studies for the treatment of an acute manic or mixed episode and not had any major protocol violations..

Exclusion Criteria:

Patients with unstable medical conditions or clinically significant laboratory

abnormalities.
Intervention: Sertraline
Trial phase: Phase 4
ATC code: N06AB06
SMILES: CN[C@H]1CC[C@@H](c2ccc(Cl)c(Cl)c2)c2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
Eligibility criteria:
Inclusion Criteria:

Video electroencephalogram (vEEG) confirmed diagnosis of NES
Have at least one nonepileptic seizure per month
Comorbid diagnosis of either depression, anxiety, or post traumatic stress disorder (PTSD)
Able to complete self report symptom scales
Not receiving optimized antidepressant medication

Exclusion Criteria:

Equivocal electroencephalogram (EEG) findings
Current suicidality, litigation, or self-mutilation
Using monoamine oxidase inhibitors (MAOIs), pimozide, or sumatriptan
Allergy/sensitivity to sertraline
Current alcohol/drug dependence
Serious medical illness requiring current hospitalization