anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Tiotropium bromide
Trial phase: Phase 2
ATC code: R03BB04
SMILES: C[N+]1(C)C2CC(OC(=O)C(O)(c3cccs3)c3cccs3)CC1C1OC12.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 76
Group description: Tiotropium bromide via (Spiriva® Handihaler®)

Tiotropium bromide via (Spiriva® Handihaler®): Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI
Eligibility criteria:
Inclusion Criteria:

40-75 years of age
Clinical diagnosis of moderate to severe COPD
Current/ex-smokers with at least 10 pack-year smoking history
Post-bronchodilator FEV1 ≥ 30% and ≤ 70% predicted normal values
Post-bronchodilator FEV1/FVC ratio of ≤ 0.70
Post-bronchodilator improvement in FEV1 ≥ 12% and ≤ 30%, and a minimum of 100 mL
Willing and able to remain at the study site for at least 24 hours at each study visit
Signed written informed consent

Exclusion Criteria:

Current evidence or recent history of any clinically significant and unstable disease or abnormality (e.g., myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes)
Primary diagnosis of asthma
History of malignancy within the past 5 years
History of COPD exacerbation within 6 weeks of Screening
Daily oxygen therapy > 10 hours per day
Systemic steroids use within 6 weeks of Screening
Respiratory tract infection within 6 weeks of Screening
History of tuberculosis, bronchiectasis
History of urinary retention or bladder neck obstruction type symptoms
History of glaucoma
Prolonged QTc interval (>460msec) or history of long QT syndrome
Recent history of alcohol or drug abuse
Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable birth control methods
History of hypersensitivity or intolerance to aerosol medications
Participation in another investigational drug study within 30 days of Screening
Intervention: Timolol
Trial phase: Phase 3
ATC code: C07AA06 | C07BA06 | C07DA06 | S01ED01 | S01ED51
SMILES: [H][C@](O)(CNC(C)(C)C)COc1nsnc1N1CCOCC1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 3
Group description: 1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of congenital, juvenile glaucoma
Requires treatment with IOP-lowering medication in one or both eyes

Exclusion Criteria:

Surgical intervention is indicated or planned to lower IOP
Abnormally low body weight (below 5th percentile)
Any active eye infection or disease
Anticipated use of contact lenses during the study
Topical ocular steroid use within 2 months
History of ocular trauma in either eye
Required chronic use of ocular medications (other than study medication) during the study (intermittent use of artificial tears permitted)
Intervention: Brimonidine Tartrate
Trial phase: Phase 2
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
Eligibility criteria:
Inclusion Criteria:

Sign Informed Consent document.
Diagnosis of open-angle glaucoma or ocular hypertension
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
Severe central vision loss in either eye.
Any chronic or recurrent inflammatory eye disease.
Ocular trauma within the preceding 6 months.
Ocular infection or ocular inflammation within the preceding 3 months.
Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
Any intraocular surgery within the preceding 6 months.
Any ocular laser surgery within the preceding 3 months.
History or current evidence of severe illness or any other conditions which would make the subject, in the opinion of the Investigator, unsuitable for the study.
Other protocol-defined exclusion criteria may apply.
Intervention: Sodium phosphate P 32
Trial phase: Phase 4
ATC code: V10XX01
SMILES: O=[32P]([O-])([O-])O.[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1041
Group description: Oral sodium phosphate solution: OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
Eligibility criteria:
Inclusion Criteria:

Between 18 and 70 years of age, inclusive
Scheduled for colonoscopy within 21 days of the screening visit
Able to swallow tablets the size of a multivitamin without difficulty

Exclusion Criteria:

History of biopsy-proven acute phosphate nephropathy
Known allergy or hypersensitivity to treatment arms
History of gastric stapling or bypass procedure or history of gastric retention
History of any other sodium phosphate preparation within 6 months prior to colonoscopy
Intervention: Acetylcysteine
Trial phase: Phase 1
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: single intravenous administration of N-acetylcysteine in PD patients
Eligibility criteria:
Inclusion Criteria:

All participants must be 18 years or older.
All enrollees must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent.
Individuals with medically stable Parkinson's disease (in the opinion of the investigator).
All participants must not have taken antioxidants coenzyme Q-10, vitamin C, or vitamin E for 3 weeks prior to the study.
Absence of dementia in all subjects, as determined by pre-scanning cognitive assessment.
Control subjects who are able to undergo MRS

Exclusion Criteria:

Inability to undergo MRI scanning without sedation
Medically unstable conditions in any group as determined by the investigators
Pregnant or lactating or those women of child-bearing age that are not using acceptable forms of contraception
Diagnosis of asthma that is presently being treated with ANY medication, or past history of asthma/bronchospasm resulting in an emergency room visit, hospitalization or treatment
Unable to adhere to study protocol for whatever reason
Intervention: Acetylcysteine
Trial phase: Phase 1
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: single intravenous administration of N-acetylcysteine in GD patients
Eligibility criteria:
Inclusion Criteria:

All participants must be 18 years or older.
All enrollees must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent.
Individuals with medically stable Parkinson's disease (in the opinion of the investigator).
All participants must not have taken antioxidants coenzyme Q-10, vitamin C, or vitamin E for 3 weeks prior to the study.
Absence of dementia in all subjects, as determined by pre-scanning cognitive assessment.
Control subjects who are able to undergo MRS

Exclusion Criteria:

Inability to undergo MRI scanning without sedation
Medically unstable conditions in any group as determined by the investigators
Pregnant or lactating or those women of child-bearing age that are not using acceptable forms of contraception
Diagnosis of asthma that is presently being treated with ANY medication, or past history of asthma/bronchospasm resulting in an emergency room visit, hospitalization or treatment
Unable to adhere to study protocol for whatever reason
Intervention: Acetylcysteine
Trial phase: Phase 1
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: single intravenous administration of N-acetylcysteine in control subjects
Eligibility criteria:
Inclusion Criteria:

All participants must be 18 years or older.
All enrollees must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent.
Individuals with medically stable Parkinson's disease (in the opinion of the investigator).
All participants must not have taken antioxidants coenzyme Q-10, vitamin C, or vitamin E for 3 weeks prior to the study.
Absence of dementia in all subjects, as determined by pre-scanning cognitive assessment.
Control subjects who are able to undergo MRS

Exclusion Criteria:

Inability to undergo MRI scanning without sedation
Medically unstable conditions in any group as determined by the investigators
Pregnant or lactating or those women of child-bearing age that are not using acceptable forms of contraception
Diagnosis of asthma that is presently being treated with ANY medication, or past history of asthma/bronchospasm resulting in an emergency room visit, hospitalization or treatment
Unable to adhere to study protocol for whatever reason
Intervention: Olanzapine
Trial phase: Phase 4
ATC code: N05AH03 | N05AH53
SMILES: Cc1cc2c(s1)Nc1ccccc1N=C2N1CCN(C)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Randomized to continue with sertraline and olanzapine under double-blind conditions
Eligibility criteria:
Inclusion Criteria:

Aged 18-85 years, inclusive
Diagnosis: Diagnostic Statistical Manual-IV Trade Revision (DSM IV-TR) non-bipolar major depression with psychotic features established by both clinical interview with research psychiatrist and administration of SCID-IV.
Score >2 on Schedule for Affective Disorders (SADS) delusion severity item
Score >1 on any of the three conviction items of the Delusion Assessment Scale (DAS) (does not alter belief in response to reality testing)
17-item HAM-D score of >20

Exclusion Criteria:

Current or lifetime DSM-IV-TR history of schizophrenia or other psychotic disorders or meeting current criteria for brief psychotic disorder, body dysmorphic disorder or obsessive-compulsive disorder
Current or lifetime DSM-IV-TR bipolar affective disorder
History of DSM-IV-TR defined alcohol or substance abuse or dependence within the past three months
Dementia or clinically significant cognitive impairment prior to index episode of depression, and/or a mean score >3 on 26-item caregiver assessment
Type 1 diabetes mellitus (defined as insulin-dependent diabetes mellitus with onset before age 35, and/or diabetes mellitus complicated by prior documented episode of ketoacidosis
Acute or unstable medical illness within the past 3 months; current abnormal serum free T4; current abnormally low vitamin B4 or folic acid level; medical conditions and/or medications for which psychotic or depressive symptoms can be a direct manifestation; neurological disease associated with extrapyramidal signs and symptoms; epilepsy, if the person has had one or more grand mal seizures within the past 12 months.
The need for treatment with any psychotropic medication other than sertraline, olanzapine or lorazepam; or with an anticonvulsant medication with mood-stabilizing properties.
Current pregnancy or plan to become pregnant during the course of the study; breast feeding in women with infants.
A documented history of being unable to tolerate olanzapine or sertraline including significant bradycardia (heart rate of <50 bpm), and serum sodium level of 129mmol/L or below.
History of non-response of the index episode of psychotic depression to at least a 6-week trial of at least 150mg/day sertraline combined with 15mg/day olanzapine
Patients showing ongoing improvement in current episode of psychotic depression with treatment other than sertraline or olanzapine
Patients who are in immediate need of electroconvulsive therapy (ECT) (imminent risk of suicide, refusing to eat, catatonic)
Intervention: Betamethasone
Trial phase: Phase 4
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 153
Group description: Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of branch retinal vein occlusion in at least one eye
Visual acuity between 20/400 to 20/40

Exclusion Criteria:

Active eye infection
Ocular hypertension which is not controlled on monotherapy (one medication)
Anticipated need for eye surgery during the study
Cataract surgery in either eye within 3 months
Eye surgery including laser of any type within 6 months
Anti-VEGF treatment in either eye (eg, Lucentis®) within 3 months or systemic anti-VEGF treatment (eg, Avastin) within 6 months
Use of ocular steroids within 3 months
Use of steroids (except for inhaled or intranasal) within 1 month or anticipated use during the study
Intervention: CID 11593706
Trial phase: Phase 4
SMILES: C=CCN.ClCC1CO1.O=C(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Sevelamer Carbonate for periods 1 and 2
Eligibility criteria:
Inclusion Criteria:

Male or female subjects ≥18 years of age able to give written informed consent to the study
Hemodialysis dependent chronic kidney disease stage 5D patients
Taking sevelamer carbonate tablets or sevelamer hydrochloride as phosphate binder monotherapy
Taking 3 or more sevelamer carbonate or sevelamer hydrochloride tablets per day

Exclusion Criteria:

Estimated life expectancy of less than 6 months and for cancer patients, an Eastern Cooperative Oncology Group (ECOG) Performance Status >1
Active malignancy within the past 5 years. Basal or squamous cell skin cancer is not exclusionary. History of malignancy is not an exclusion
Known hypersensitivity reaction to calcium-based phosphate binders
Anticipated renal transplantation during the study
Pregnant or sexually active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception.
Intervention: SequestOx
Trial phase: Phase 3
SMILES: COc1ccc2c3c1OC1C(=O)CCC4(O)C(C2)N(C)CCC314.Cl.Cl.O=C1CCC2(O)C3Cc4ccc(O)c5c4C2(CCN3CC2CC2)C1O5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 395
Group description: Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators' discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator's discretion.
Eligibility criteria:
Inclusion Criteria:

Subject has moderate to severe chronic noncancer pain (duration of at least 3 months) requiring a continuous around-the-clock opioid analgesic for an extended period of time. Conditions may include, but are not limited to, osteoarthritis, chronic low back pain, or other opioid -responsive pain conditions.
Subject agrees to refrain from taking opioid medications other than study drug during the study. (The exception is during the Pre-Treatment Period when the subject may continue current opioid therapy to guide first 4 weeks of the Treatment Period when the subject may administer immediate-release oxycodone to support conversion to study drug.)

Exclusion Criteria:

Subject has moderate or severe chronic pain due to cancer, migraine, recent trauma, infection, or other pain expected to be short-term (duration less than 3 months).
Subject has a documented history of alcohol or drug abuse within 1 year prior to study entry that in the Investigator's judgment would impact subject participation.
Subject has ongoing or active alcohol or drug abuse that in the Investigator's judgment would impact subject participation.
Subject has a positive urine drug test for illicit drug use or medications at screening without legitimate medical explanation.
Subject has a clinically significant medical condition (e.g., cardiovascular, neurological, renal, hepatic, pulmonary, gastrointestinal, endocrine, hematological, immunological, rheumatological, metabolic, or psychiatric) or physical examination, vital signs (VS), 12-lead electrocardiogram (ECG), clinical laboratory abnormalities that in the opinion of the Investigator would impact the safety of the subject during study participation.
If female, the subject is pregnant or breast-feeding.
Subject has a known history or known hypersensitivity to oxycodone, oxycodone salts, naltrexone or acetaminophen,or pharmacological similar compounds.
Subject is historically non-responsive to oxycodone treatment or requires greater than 160 mg oxycodone in a 24-hour time interval.
Intervention: Tasimelteon
Trial phase: Phase 2 | Phase 3
ATC code: N05CH03
SMILES: CCC(=O)NC[C@@H]1C[C@H]1c1cccc2c1CCO2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 254
Group description: 20 mg tasimelteon capsules, PO daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Subjects with diagnosis of MDD, single or recurrent episode, according to DSM-IV TR criteria;
Current episode ≥4 weeks and ≤1 year;
CGI-Severity score ≥4 at screening and baseline.

Exclusion Criteria:

Lifetime history of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive-compulsive disorder;
Any other current Axis I (except general anxiety disorder as long as it is not considered the primary disorder) or Axis II disorder;
A positive test for drugs of abuse at the screening visit and/or history of drug or alcohol abuse/dependence as defined in DSM-IV TR, Diagnostic Criteria for Drug and Alcohol Abuse and Dependence, within the past 12 months;
Formal psychotherapy within 3 months of the screening visit. General supportive psychotherapy is acceptable;
Participation in a previous tasimelteon trial. Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Midazolam
Trial phase: Phase 4
ATC code: N05CD08
SMILES: Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 135
Group description: 2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion

Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level
Eligibility criteria:
Inclusion Criteria:

All patients undergoing elective outpatient colonoscopy

Exclusion Criteria:

Age less than 18 years
Allergy to propofol, soybeans, eggs or midazolam
Chronic intake of benzodiazepines
History of colorectal surgery
ASA class IV, short and tick neck, difficult intubation due to inability to open the mouth widely
Pregnancy
Refusal, inability or unwillingness to give written consent
Patients scheduled for advanced therapeutic colonoscopy or for more than one endoscopic procedure
Intervention: Propofol
Trial phase: Phase 4
ATC code: N01AX10
SMILES: CC(C)c1cccc(C(C)C)c1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 135
Group description: 2 ml saline followed by continuous propofol iv infusion

Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level
Eligibility criteria:
Inclusion Criteria:

All patients undergoing elective outpatient colonoscopy

Exclusion Criteria:

Age less than 18 years
Allergy to propofol, soybeans, eggs or midazolam
Chronic intake of benzodiazepines
History of colorectal surgery
ASA class IV, short and tick neck, difficult intubation due to inability to open the mouth widely
Pregnancy
Refusal, inability or unwillingness to give written consent
Patients scheduled for advanced therapeutic colonoscopy or for more than one endoscopic procedure
Intervention: Meropenem
Trial phase: Phase 4
ATC code: J01DH02 | J01DH52
SMILES: [H][C@]12[C@@H](C)C(S[C@@H]3CN[C@H](C(=O)N(C)C)C3)=C(C(=O)O)N1C(=O)[C@]2([H])[C@@H](C)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 30
Group description: All 30 participants will receive meropenem as a 3 hour infusion.

meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion.
Eligibility criteria:
Inclusion Criteria:

Cystic Fibrosis
Hospitalized with acute pulmonary exacerbation
Caused by Pseudomonas aeruginosa or other bacteria against which meropenem would be an appropriate antibiotic treatment

Exclusion Criteria:

Known allergy to meropenem
Require less than 3 days of meropenem in the hospital
Require another systemic Beta-lactam antibiotic to treat a concomitant pathogen
Known fungal or viral infection
Females in their 2nd or 3rd trimester of pregnancy
Moderate to severe renal dysfunction, as defined by a creatinine clearance less than 50 ml/min/1.73m2 (by use of Schwartz method)
History of solid organ transplantation within previous 6 months
Active or recent (within 30 days) participation in another antibiotic clinical trial