anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Brexpiprazole
Trial phase: Phase 3
ATC code: N05AX16
SMILES: O=c1ccc2ccc(OCCCCN3CCN(c4cccc5sccc45)CC3)cc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: The all-patients-treated set (APTS) comprises all patients who took at least one dose of brexpiprazole.
Eligibility criteria:
Inclusion Criteria - at Screening:

The patient has a Major Depressive Episode (MDE) associated to Major Depressive Disorder (MDD), diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR™). The current MDE should be confirmed using the Mini International Neuropsychiatric Interview (MINI).
The patient has an inadequate response to at least one antidepressant treatment (including the treatment the patient is taking at screening) in the current MDE, as documented by self-report as less than a pre-defined response on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ).
The patient has a pre-defined Montgomery Aasberg Depression Rating Scale (MADRS) total score, and a pre-defined Clinical Global Impression - Severity of Illness (CGI-S) score at screening, and has had the current MDE for ≥10 weeks.
The patient is currently treated for the current MDE with an adequate selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) antidepressant treatment for ≥6 weeks, at the same dosage for ≥2 weeks.
The patient has sleep disturbances (difficulty falling asleep and/or difficulty staying asleep and/or problem waking up too early) confirmed by a pre-defined Insomnia Severity Index (ISI) score.
The patient agrees to protocol-defined use of effective contraception.

Entry Criteria to Treatment Period (Baseline Visit):

The patient still fulfils DSM-IV-TR™ criteria for MDE.
The patient received the same SSRI or SNRI antidepressant treatment at adequate dose during the entire lead-in period.
The patient has a pre-defined MADRS total score.
The patient's improvement in the MADRS total score is a pre-defined percentage compared to screening.
The patient has a pre-defined Clinical Global Impression - Global Improvement (CGI-I) score.
The patient has sleep disturbances (difficulty falling asleep and/or difficulty staying asleep and/or problem waking up too early) confirmed by a pre-defined ISI score.
The patient has sleep disturbances confirmed by pre-defined Latency to Persistent Sleep (LPS) and pre-defined Sleep Efficiency (SE).

Exclusion Criteria:

- The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.
Intervention: Ipratropii bromidum
Trial phase: Phase 4
ATC code: R03BB01
SMILES: CC(C)[N+]1(C)C2CCC1CC(OC(=O)C(CO)c1ccccc1)C2.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 96
Group description: 500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
Eligibility criteria:
Inclusion criteria:

All patients must sign an informed consent.
Male or female patients aged >= 40 years and <= 80 years
All patients must be diagnosed with COPD and must meet the following spirometric criterion: post-bronchodilator forced expiratory volume in 1 second (FEV1) < 70% of forced vital capacity (FVC) at Screening Visit (Visit 1).
All patients have relatively stable COPD (i.e. have no COPD exacerbation within 4 weeks prior to Screening Visit).
All patients are about to receive selective surgical procedures of lobectomy or right bilobectomy or segmentectomy under general anaesthesia, whilst the estimated time of surgical procedures lasts for not less than 2 hours, and the estimated time of general anaesthesia lasts for not less than 3 hours and not longer than 5 hours.
Patients must be able to perform all study related procedures including technically acceptable pulmonary function tests (PFTs).

Exclusion criteria:

Patients who need maintenance treatment of bronchodilators (including anticholinergics, ß-agonists, xanthines).
Patients with a recent history (i.e. six months or less) of myocardial infarction
Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year
Patients with symptomatic chronic heart failure (i.e. New York Heart Association functional class III-IV)
Known narrow angle glaucoma
Patients with prostatic hyperplasia or bladder neck obstruction with significant symptoms
Patients with a history of asthma, allergic rhinitis or who have a blood eosinophil count >= 600 / mm3 (0.6×10^9/L). A repeat eosinophil count will not be conducted in these patients
Intervention: Ketamine
Trial phase: Phase 1 | Phase 2
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: 0.5 mg/kg, I.V. (in the vein)

Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes
Eligibility criteria:
INCLUSION CRITERIA:

Bipolar depression with current major depressive episode (MDE). Participants may be psychiatric medication-free, or if on psychiatric medication, not responding adequately given current MDE with suicidal ideation.
Moderate to severe suicidal ideation
18-65 years old
Patients will only be enrolled if they agree to voluntary admission to an inpatient research unit at the New York State Psychiatric Institute (NYSPI) for infusion phase of treatment.
Pre-menopausal female participants of child-bearing potential must be willing to use an acceptable form of birth control during study participation such as condoms, diaphragm, oral contraceptive pills
Able to provide informed consent
Subjects 61-65 years old must score 25 or higher on the Mini-Mental State Examination (MMSE) at screening

EXCLUSION CRITERIA:

Unstable medical condition or neurological illness, including baseline hypertension (BP>140/90) or significant history of cardiovascular illness
Significant ECG abnormality
Pregnancy and/or lactation
Current psychotic symptoms
Contraindication to any study treatment
Current or past ketamine abuse or dependence ever (lifetime); any other drug or alcohol dependence within past 6 months; suicidality only due to binge substance use or withdrawal
Inadequate understanding of English
Prior ineffective trial of or adverse reaction to ketamine or midazolam
Opiate use greater than total daily dose of 20mg Oxycodone or equivalent during the 3 days pre-infusion
Intervention: Midazolam
Trial phase: Phase 1 | Phase 2
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: 0.02 mg/kg, I.V. (in the vein)

Ketamine: Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes

Midazolam: Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
Eligibility criteria:
INCLUSION CRITERIA:

Bipolar depression with current major depressive episode (MDE). Participants may be psychiatric medication-free, or if on psychiatric medication, not responding adequately given current MDE with suicidal ideation.
Moderate to severe suicidal ideation
18-65 years old
Patients will only be enrolled if they agree to voluntary admission to an inpatient research unit at the New York State Psychiatric Institute (NYSPI) for infusion phase of treatment.
Pre-menopausal female participants of child-bearing potential must be willing to use an acceptable form of birth control during study participation such as condoms, diaphragm, oral contraceptive pills
Able to provide informed consent
Subjects 61-65 years old must score 25 or higher on the Mini-Mental State Examination (MMSE) at screening

EXCLUSION CRITERIA:

Unstable medical condition or neurological illness, including baseline hypertension (BP>140/90) or significant history of cardiovascular illness
Significant ECG abnormality
Pregnancy and/or lactation
Current psychotic symptoms
Contraindication to any study treatment
Current or past ketamine abuse or dependence ever (lifetime); any other drug or alcohol dependence within past 6 months; suicidality only due to binge substance use or withdrawal
Inadequate understanding of English
Prior ineffective trial of or adverse reaction to ketamine or midazolam
Opiate use greater than total daily dose of 20mg Oxycodone or equivalent during the 3 days pre-infusion
Intervention: Brexpiprazole
Trial phase: Phase 3
ATC code: N05AX16
SMILES: O=c1ccc2ccc(OCCCCN3CCN(c4cccc5sccc45)CC3)cc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)

Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally
Eligibility criteria:
Inclusion Criteria:

The patient is judged to benefit from adjunctive treatment with brexpiprazole according to the clinical opinion of the investigator.
The patient had MDD at entry in lead-in brexpiprazole studies, NCT01838681 / 14570A or NCT01837797 / 14571A, diagnosed according to DSM-IV-TR™.
The patient agrees to protocol-defined use of effective contraception.

Exclusion Criteria:

The patient has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
The patient has been diagnosed with a psychiatric disorder other than MDD during the lead-in studies NCT01838681 / 14570A or NCT01837797 / 14571A.
The patient, in the opinion of the investigator or according to C-SSRS, is at significant risk of suicide.
The patient has any relevant medical history or current presence of systemic disease.
The patient has, at the Baseline Visit an abnormal ECG that is, in the investigator's opinion, clinically significant.
The patient has a moderate or severe ongoing adverse event related to study medication from the lead-in studies considered of potential safety risk by the investigator.
The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.
Intervention: Caspofungin
Trial phase: Phase 2
ATC code: J02AX04
SMILES: CCC(C)CC(C)CCCCCCCCC(=O)NC1CC(O)C(NCCN)NC(=O)C2C(O)CCN2C(=O)C(C(O)CCN)NC(=O)C(C(O)C(O)c2ccc(O)cc2)NC(=O)C2CC(O)CN2C(=O)C(C(C)O)NC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 33
Group description: Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
Eligibility criteria:
Inclusion Criteria:

Culture-confirmed invasive Candida infection

Exclusion Criteria:

Candida disease limited to the oropharynx, esophagus, or other mucosal or superficial skin surfaces
Positive culture for Candida only from sputum, broncho-alveolar lavage, catheter tip, or previously placed indwelling non-vascular catheters or drains
Prosthetic device as the suspected site of Candida infection
Active co-infection with a non-Candida fungal organism
Received >48 hours of systemic antifungal treatment since the positive Candida index culture was collected as therapy for the present episode of invasive candidiasis
Failed prior systemic antifungal therapy for the present episode of invasive candidiasis
Diagnosis of acute hepatitis or cirrhosis
Scheduled or anticipated to receive rifampin or other systemic antifungal therapy while on study therapy
History (including participant's mother) of allergy, hypersensitivity, or any serious reaction to caspofungin or other member of the echinocandin class, or to amphotericin B deoxycholate or other member of the polyene class
Severe congenital disorder known to lower immune response
Intervention: SODIUM CHLORIDE
Trial phase: Phase 1 | Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Hypertonic saline (3%), 3mL every 6hrs for up to 7 days

Hypertonic saline (3%)
Eligibility criteria:
Inclusion Criteria:

invasive mechanical ventilation of < 12 hrs duration prior to enrollment
expected duration of mechanical ventilation of > 48hrs from enrollment
age < 18yo

Exclusion Criteria:

inclusion in another clinical study
cystic fibrosis
status asthmaticus
pulmonary hemorrhage/contusion
home O2 use
home non-invasive positive pressure (CPAP/BiPAP) ventilation use
pre-existing tracheostomy
prescription of mucolytic medication by primary clinical team
allergy to inhaled saline/hypertonic saline or albuterol
Intervention: Budesonide
Trial phase: Phase 1 | Phase 2
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 | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Buparid 1 mg budesonide/2 ml nebuliser solution

Budesonide: Inhalation
Eligibility criteria:
Inclusion Criteria:

Patient with confirmed diagnosis of chronic rhinosinusitis (CRS) with polyposis nasi grade I-III
Patient with a PNIF of > 7 l/min separated for left and right side of the nose
Patient's written informed consent
Male or female,>= 18 years of age
Patient is able to undergo nasal therapy without restrictions
Capable of understanding the purpose and risk of the clinical trial
Female patients with childbearing potential must have a negative urine pregnancy test prior to first IMP administration
Patient has completed correctly the diary during the Wash-in Phase

Exclusion Criteria:

Patients with cystic fibrosis
Patients with polyposis nasi grade IV
Patients with prior sinonasal surgery (exemption: polypectomy)
Patients with primary ciliaritis
Pregnant or breastfeeding women
Patients with suspected active upper airway infection
Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
Drug or alcohol abuse
End-stage malignancies
Known hypersensitivity to Budesonide
Patients with oral steroid therapy within the last 4 weeks
Patients with frequent epistaxis (> 2 per month)
Intervention: Budesonide
Trial phase: Phase 1 | Phase 2
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 | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Budes® Nasal Spray 50 µg budesonide/pump

Budesonide: Nasal spray
Eligibility criteria:
Inclusion Criteria:

Patient with confirmed diagnosis of chronic rhinosinusitis (CRS) with polyposis nasi grade I-III
Patient with a PNIF of > 7 l/min separated for left and right side of the nose
Patient's written informed consent
Male or female,>= 18 years of age
Patient is able to undergo nasal therapy without restrictions
Capable of understanding the purpose and risk of the clinical trial
Female patients with childbearing potential must have a negative urine pregnancy test prior to first IMP administration
Patient has completed correctly the diary during the Wash-in Phase

Exclusion Criteria:

Patients with cystic fibrosis
Patients with polyposis nasi grade IV
Patients with prior sinonasal surgery (exemption: polypectomy)
Patients with primary ciliaritis
Pregnant or breastfeeding women
Patients with suspected active upper airway infection
Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
Drug or alcohol abuse
End-stage malignancies
Known hypersensitivity to Budesonide
Patients with oral steroid therapy within the last 4 weeks
Patients with frequent epistaxis (> 2 per month)
Intervention: Ranolazine
Trial phase: Phase 4
ATC code: C01EB18
SMILES: COc1ccccc1OCC(O)CN1CCN(CC(=O)Nc2c(C)cccc2C)CC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Ranolazine 1000mg pill twice per day plus aerobic exercise three times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold.

Ranolazine: Comparison of Ranolazine 1000mg twice per day versus placebo twice per day

Aerobic Exercise: Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)
Eligibility criteria:
Inclusion Criteria:

Documented CAD diagnosis
Stable angina ≥ 3 months

Exclusion Criteria:

Class III or IV heart failure
Myocardial Infarction or coronary revascularization procedure within 2 months
QT interval > 500ms or prescribed medication known to prolong the QTc interval
Contraindicated Medications
Metformin dose > 1700mg/day
Class Ia, Ic and III anti-arrhythmics
CYP3A inhibitors
Simvastatin >20mg/day
Severe renal disease (< 30ml/min creatinine clearance)
Currently on dialysis
Lack of transportation to the exercise and testing facilities
Implanted pacemaker that is not rate responsive
Intervention: Rivastigmine
Trial phase: Phase 4
ATC code: N06DA03
SMILES: CCN(C)C(=O)Oc1cccc([C@H](C)N(C)C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 181
Group description: Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Have a diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria and have a clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
MMSE score of ≥ 10 and ≤ 26
The treatment naïve patient and the one who have stopped the donepezil, galantamine, huperzine A, or memantine at least 2 weeks
Be in stable medical condition
Have signed off informed consent form by patients or his/her legal guardian

Key Exclusion Criteria:

Severe AD
Patients with a history of cerebrovascular disease, Active or uncontrolled epilepsy, Active hypothyroidism, asthma, CNS infection, other Neurodegenerative disorders, an advanced, severe, progressive, or unstable medical condition
Attending other clinical trials or taking other clinical trial drugs
A score of > 4 on the Modified Hachinski Ischemic Scale (MHIS);
Patients who is using any AChEI or memantine
Intervention: Cyclosporine
Trial phase: Phase 2
ATC code: L04AD01 | S01XA18
SMILES: CC=CCC(C)C(O)C1C(=O)NC(CC)C(=O)N(C)CC(=O)N(C)C(CC(C)C)C(=O)NC(C(C)C)C(=O)N(C)C(CC(C)C)C(=O)NC(C)C(=O)NC(C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(C(C)C)C(=O)N1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 32
Group description: Intranasal midazolam administered in 200 mcL VOA

Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
Eligibility criteria:
Inclusion Criteria:

1 to 7 years of age, inclusive.
Require intranasal midazolam for minimal sedation to facilitate laceration repair.

Exclusion Criteria:

Weight less than 10 kg.
Known allergy to midazolam.
Presence of intranasal obstruction (e.g. mucous or blood) that cannot be readily cleared
Inability to speak English or Spanish
Developmental delay, psychiatric illness, neurologic impairment, or altered mental status; or illnesses associated with chronic pain (e.g. sickle cell disease, inﬂammatory bowel disease).
Foster children or wards.
Intervention: Cyclosporine
Trial phase: Phase 2
ATC code: L04AD01 | S01XA18
SMILES: CC=CCC(C)C(O)C1C(=O)NC(CC)C(=O)N(C)CC(=O)N(C)C(CC(C)C)C(=O)NC(C(C)C)C(=O)N(C)C(CC(C)C)C(=O)NC(C)C(=O)NC(C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(C(C)C)C(=O)N1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 33
Group description: Intranasal midazolam administered in 500 mcL VOA.

Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
Eligibility criteria:
Inclusion Criteria:

1 to 7 years of age, inclusive.
Require intranasal midazolam for minimal sedation to facilitate laceration repair.

Exclusion Criteria:

Weight less than 10 kg.
Known allergy to midazolam.
Presence of intranasal obstruction (e.g. mucous or blood) that cannot be readily cleared
Inability to speak English or Spanish
Developmental delay, psychiatric illness, neurologic impairment, or altered mental status; or illnesses associated with chronic pain (e.g. sickle cell disease, inﬂammatory bowel disease).
Foster children or wards.
Intervention: Cyclosporine
Trial phase: Phase 2
ATC code: L04AD01 | S01XA18
SMILES: CC=CCC(C)C(O)C1C(=O)NC(CC)C(=O)N(C)CC(=O)N(C)C(CC(C)C)C(=O)NC(C(C)C)C(=O)N(C)C(CC(C)C)C(=O)NC(C)C(=O)NC(C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(C(C)C)C(=O)N1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 31
Group description: Intranasal midazolam administered in 1000 mcL VOA.

Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
Eligibility criteria:
Inclusion Criteria:

1 to 7 years of age, inclusive.
Require intranasal midazolam for minimal sedation to facilitate laceration repair.

Exclusion Criteria:

Weight less than 10 kg.
Known allergy to midazolam.
Presence of intranasal obstruction (e.g. mucous or blood) that cannot be readily cleared
Inability to speak English or Spanish
Developmental delay, psychiatric illness, neurologic impairment, or altered mental status; or illnesses associated with chronic pain (e.g. sickle cell disease, inﬂammatory bowel disease).
Foster children or wards.