anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Iron sucrose
Trial phase: Phase 3
ATC code: B03AB02 | V03AE05
SMILES: O.O.O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 506
Group description: Iron sucrose, administered IV
Eligibility criteria:
Inclusion Criteria includes:

Men and women, ≥ 18 years
Hb ≤ 11 g/dL
Chronic renal impairment, as defined by either (i) eGFR < 60 mL/min/1.73m2 at screening (as calculated by modification of diet in renal disease (MDRD)), or (ii) Estimated Glomerular Filtration Rate (eGFR) < 90 mL/min/1.73m2 at screening and kidney damage as indicated by abnormalities in urine composition per medical history and/or intermediate/high risk of cardio-vascular disease based on the Framingham model
Screening s-ferritin ≤ 100 ng/mL, or ≤ 300 ng/mL if Transferrin Saturation (TSAT) ≤ 30 %
Either no Erythropoiesis Stimulating Agent (ESAs) or ESAs as a stable dose 4 weeks before randomisation
Willingness to participate and signing the informed consent form

Exclusion Criteria includes:

Anaemia predominantly caused by factors other than IDA
Hemochromatosis or other iron storage disorders
Previous serious hypersensitivity reactions to any IV iron compounds
Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
Undergoing dialysis for treatment of CKD
Planned surgical procedure within the trial period
Decompensated liver cirrhosis or active hepatitis
Alcohol or drug abuse within the past 6 month.
Pregnant or nursing women.
Intervention: Iron sucrose
Trial phase: Phase 3
ATC code: B03AB02 | V03AE05
SMILES: O.O.O.OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O.[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Fe+3].[Na+].[Na+].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[OH-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 494
Group description: Iron sucrose, administered IV
Eligibility criteria:
Inclusion criteria includes:

Men or women ≥ 18 years
Subjects having IDA caused by different etiologies
Subjects with intolerance to oral iron therapy or a need for rapid repletion of iron stores:
Haemoglobin (Hb) ≤ 11 g/dL
Transferrin Saturation (TSAT) < 20 %
S-ferritin < 100 ng/mL
Willingness to participate and signing the informed consent form

Exclusion Criteria includes :

Anemia predominantly caused by factors other than IDA
Hemochromatosis or other iron storage disorders
Previous serious hypersensitivity reactions to any IV iron compound
Erythropoiesis stimulating agent (ESA) treatment
Prior to screening or during the trial period; has or will be treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy
Will require a surgical procedure that necessitated general anesthesia prior to screening or during the trial period
Alanine aminotransferase and/or aspartate aminotransferase > 3 times upper limit of normal
Required dialysis for treatment of chronic kidney disease (CKD)
Alcohol or drug abuse within the past 6 months
Pregnant or nursing women
Intervention: 4-(7-Hydroxy-2-isopropyl-4-oxoquinazolin-3(4H)-YL)benzonitrile
Trial phase: Phase 2
SMILES: CC(C)c1nc2cc(O)ccc2c(=O)n1-c1ccc(C#N)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: treatment participants from both sequences
Eligibility criteria:
Inclusion Criteria:

Normal eye exam except for refractive error at baseline.
Myopia should not exceed -4.00 Diopters (sphere) and 3.00 diopters of astigmatism, with spherical equivalent not higher than -4.50, confirmed by manifest refraction at baseline.

Exclusion Criteria:

Monocular patient (including amblyopia) or best corrected visual acuity score worse than 20/80 (Snellen) or 55 letters (EDTRS), at baseline.
Any systemic or ocular disease that might affect wound healing (such as severe rheumatoid arthritis or diabetes or history of keloid formation) or a history of ocular trauma, uveitis, infection, or inflammation in the 6 months prior to baseline.
Previous refractive or corneal surgery (such as LASIK, PRK, radial keratotomy, pterygium removal, corneal transplantation).
Chronic pain of any etiology or any significant illness which has not resolved within two (2) weeks prior to initial dosing.

Other inclusion and exclusion criteria apply.
Intervention: Pimavanserin
Trial phase: Phase 3
ATC code: N05AX17
SMILES: CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 198
Group description: Patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 1, Week 2 and Week 3 visit, the dose could be increased to 34 mg QD or decreased to 10 mg QD at the investigator's discretion (to improve symptom reliev or tolerability, respectively). Thereafter, the daily dose was to remain the same for the remainder of the study.

Patients were to continue their background antipsychotic treatment.
Eligibility criteria:
Inclusion Criteria:

Adults patients, between 18 and 55 years of age
A clinical diagnosis of schizophrenia with a minimum duration of 1 year

The main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below:

Aripiprazole

Aripiprazole long-acting injectables:

Abilify Maintena®
Aristada®
Risperidone
Risperidone long-acting injection
Olanzapine
Lurasidone
Cariprazine
Brexpiprazole
Asenapine
Has had a partial but inadequate response to antipsychotic treatment
Has a history of response to antipsychotic treatment other than clozapine

Exclusion Criteria:

Patient has a psychiatric disorder other than schizophrenia
Patient has a history of resistance to antipsychotic treatment

A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana

a. Patients with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation

Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
Patient has had a myocardial infarction in the last six months
Patient is taking a medication or drug that prolongs the QT interval or has a family or personal history or symptoms of long QT syndrome

Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
Intervention: Pimavanserin
Trial phase: Phase 2
ATC code: N05AX17
SMILES: CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 201
Group description: Treatment was to be started at a daily dose of pimavanserin 20 mg; this dose was to be continued for the first 2 weeks of treatment . Subsequently, during the flexible-dosing period of double-blind treatment period (Weeks 2-8), the dose could be continued unchanged, increased to up to 34 mg daily, or decreased to up to 10 mg daily at the investigator's discretion, based on clinical benefit and safety/tolerability. No dose adjustments were allowed during the fixed-dosing period of the double-blind treatment period (Weeks 8-26).

Patients were to continue their background antipsychotic treatment
Eligibility criteria:
Inclusion Criteria:

Adult patients, between 18 and 55 years of age
A clinical diagnosis of schizophrenia with a minimum duration of 1 year
Has predominant negative symptoms according to predefined study criteria

The main background antipsychotic with which the subject is being treated must be one of the antipsychotics listed below:

Aripiprazole

Aripiprazole long-acting injectables:

Abilify Maintena®
Aristada®
Risperidone
Risperidone long-acting injection
Olanzapine
Lurasidone
Cariprazine
Brexpiprazole
Asenapine

Exclusion Criteria:

Patient has a psychiatric disorder other than schizophrenia

A urine drug screen (UDS) result at Baseline that indicates the presence of any tested prohibited substance of potential abuse, except marijuana

a. Patients with a result indicating the presence of marijuana are permitted if they agree to abstain from marijuana use during the study and the medical monitor approves the subject's participation

Patient has current evidence of a serious and/or unstable psychiatric, neurologic, cardiovascular, respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
Patient has had a myocardial infarction in the last six months
Patient has a family or personal history or symptoms of long QT syndrome
Patient has been hospitalized due to inadequate family support or care at the patient's primary residence, during the 8 weeks prior to screening

Patients will be evaluated at screening to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
Intervention: Zuranolone
Trial phase: Phase 2
SMILES: [H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Participants received SAGE-217 10 mg on Day 1, 20 mg on Day 2 and 30 mg on Days 3 to 7 as an oral solution with food in the morning.
Eligibility criteria:
Key Inclusion Criteria:

Participant must have a diagnosis of Essential Tremor (ET), defined as bilateral postural tremor and kinetic tremor, involving hands and forearms, that is visible and persistent and the duration is >5 years prior to screening.

Key Exclusion Criteria:

Participant has presence of abnormal neurological signs other than tremor or Froment's sign.
Participant has presence of known causes of enhanced physiological tremor.
Participant has concurrent or recent exposure (14 days prior to admission visit) to tremorogenic drugs.
Participant has had direct or indirect trauma to the nervous system within 3 months before the onset of tremor.
Participant has historical or clinical evidence of tremor with psychogenic origin.
Participant has convincing evidence of sudden tremor onset or evidence of stepwise deterioration of tremor.
Intervention: Zuranolone
Trial phase: Phase 2
SMILES: [H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Participants in Part A received a 10-mg dose of SAGE-217, capsules administered with food in the morning on Day 1, 20 mg with food on Day 2 and 30 mg with food daily on Days 3 to 7.
Eligibility criteria:
Key Inclusion Criteria:

Participant must have a diagnosis of Essential Tremor (ET), defined as bilateral postural tremor and kinetic tremor, involving hands and forearms, that is visible and persistent and the duration is >5 years prior to screening.

Key Exclusion Criteria:

Participant has presence of abnormal neurological signs other than tremor or Froment's sign.
Participant has presence of known causes of enhanced physiological tremor.
Participant has concurrent or recent exposure (14 days prior to admission visit) to tremorogenic drugs.
Participant has had direct or indirect trauma to the nervous system within 3 months before the onset of tremor.
Participant has historical or clinical evidence of tremor with psychogenic origin.
Participant has convincing evidence of sudden tremor onset or evidence of stepwise deterioration of tremor.
Intervention: Zuranolone
Trial phase: Phase 2
SMILES: [H][C@]12CC[C@]3([H])[C@]([H])(CC[C@@]4(C)[C@@]3([H])CC[C@]4([H])C(=O)Cn3cc(C#N)cn3)[C@@]1([H])CC[C@@](C)(O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Participants received a 10-mg dose of SAGE-217 administered with food in the evening on Day 1, 20 mg with food in the evening on Day 2, and 30 mg with food in the evening on Day 3. From Day 4 through 14 participants received a total 40-mg daily dose with food in the evening.
Eligibility criteria:
Key Inclusion Criteria:

Participant must have a diagnosis of Essential Tremor (ET), defined as bilateral postural tremor and kinetic tremor, involving hands and forearms, that is visible and persistent and the duration is >5 years prior to screening.

Key Exclusion Criteria:

Participant has presence of abnormal neurological signs other than tremor or Froment's sign.
Participant has presence of known causes of enhanced physiological tremor.
Participant has concurrent or recent exposure (14 days prior to admission visit) to tremorogenic drugs.
Participant has had direct or indirect trauma to the nervous system within 3 months before the onset of tremor.
Participant has historical or clinical evidence of tremor with psychogenic origin.
Participant has convincing evidence of sudden tremor onset or evidence of stepwise deterioration of tremor.
Intervention: BEMPEDOIC ACID
Trial phase: Phase 3
ATC code: C10AX15 | C10BA10
SMILES: CC(C)(CCCCCC(O)CCCCCC(C)(C)C(=O)O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 234
Group description: Participants received bempedoic acid 180 milligram (mg) tablet taken orally once a day.
Eligibility criteria:
Inclusion Criteria:

Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease
Fasting LDL-C ≥130 mg/dL for primary prevention or LDL-C ≥100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
Be statin-intolerant (unable to tolerate 2 or more statins)

Exclusion Criteria:

Total fasting triglyceride ≥500 mg/dL
Renal dysfunction or nephrotic syndrome or history of nephritis
Body Mass Index (BMI) ≥50 kg/m2
Significant cardiovascular disease or cardiovascular event in the past 3 months
Intervention: BEMPEDOIC ACID
Trial phase: Phase 3
ATC code: C10AX15 | C10BA10
SMILES: CC(C)(CCCCCC(O)CCCCCC(C)(C)C(=O)O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 522
Group description: Participants received a placebo tablet once daily by mouth for 4 weeks prior to the 52-week double-blind treatment period. During the treatment period, participants received a bempedoic acid 180 milligram (mg) tablet once daily by mouth for 52 weeks. Participants remained on ongoing lipid-modifying therapy (not study provided) throughout the study.
Eligibility criteria:
Inclusion Criteria:

Fasting LDL-C ≥100 mg/dL
High cardiovascular risk (diagnosis of HeFH and/or ASCVD)
Be on maximally tolerated lipid-modifying therapy (LMT), including maximally tolerated statin either alone or in combination with other LMTs

Exclusion Criteria:

Total fasting triglyceride ≥500 mg/dL
Renal dysfunction or nephrotic syndrome or history of nephritis
Body Mass Index (BMI) ≥50kg/m2
Significant cardiovascular disease or cardiovascular event in the past 3 months
Intervention: Pimavanserin
Trial phase: Phase 2
ATC code: N05AX17
SMILES: CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Drug- pimavanserin tartrate, 20 mg, taken as two 10 mg tablets, once daily by mouth

Pimavanserin 20 mg: Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth
Eligibility criteria:
Inclusion Criteria:

Male or female, 50 years of age or older

Can understand the nature of the trial and protocol requirements and provide signed informed consent

from patient, if deemed competent to provide consent
from an appropriate person (e.g. patient's Legally Authorized Representative (LAR) with the patient's assent) if patient is deemed not competent to provide informed consent.
Has a diagnosis of probable AD according to the National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines
Meets criteria for agitation according to the International Psychogeriatric Association (IPA) guidelines
Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient). Subjects must have been at their current location for at least 3 weeks prior to Screening and plan to remain at the same location for the duration of the trial.
Has a designated study partner/caregiver who is in contact with the patient at least 3 times a week on 3 separate days
Female patients must be of non-childbearing potential or must agree to use an acceptable method of contraception or abstinence , for at least 1 month prior to randomization, during the study, and 1 month following completion of the study
The patient and caregiver are willing and able to participate in all schedule evaluations and complete all required tests

Exclusion Criteria:

The agitation/aggression is attributable to concomitant medications, environmental conditions, substance abuse, or active medical or psychiatric condition
Patient is receiving skilled nursing care for any medical condition other than dementia
Treatment with an antipsychotic medication within 2 weeks of Baseline visit or 5 half lives, whichever is longer
Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
Has had a myocardial infarction within the last six months
Has a history or symptoms of long QT syndrome
Has a history of a significant psychotic disorder before or during the diagnosis of probable Alzheimer's disease (including, but not limited to schizophrenia or bipolar disorder)
Patient is bedridden or has any significant medical condition that is unstable and would place the patient at undue risk from study drug or study procedures 9. Has a sensitivity to pimavanserin or its excipients

10. Has previously participated in a clinical study with pimavanserin

11. Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on Investigator's assessment of behavior within the last 3 months at Screening or since last visit at Baseline
Intervention: Pimavanserin
Trial phase: Phase 2
ATC code: N05AX17
SMILES: CC(C)COc1ccc(CNC(=O)N(Cc2ccc(F)cc2)C2CCN(C)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: Drug- pimavanserin tartrate, 34 mg, taken as two 17 mg tablets, once daily by mouth

Pimavanserin 34 mg: Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth
Eligibility criteria:
Inclusion Criteria:

Male or female, 50 years of age or older

Can understand the nature of the trial and protocol requirements and provide signed informed consent

from patient, if deemed competent to provide consent
from an appropriate person (e.g. patient's Legally Authorized Representative (LAR) with the patient's assent) if patient is deemed not competent to provide informed consent.
Has a diagnosis of probable AD according to the National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines
Meets criteria for agitation according to the International Psychogeriatric Association (IPA) guidelines
Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient). Subjects must have been at their current location for at least 3 weeks prior to Screening and plan to remain at the same location for the duration of the trial.
Has a designated study partner/caregiver who is in contact with the patient at least 3 times a week on 3 separate days
Female patients must be of non-childbearing potential or must agree to use an acceptable method of contraception or abstinence , for at least 1 month prior to randomization, during the study, and 1 month following completion of the study
The patient and caregiver are willing and able to participate in all schedule evaluations and complete all required tests

Exclusion Criteria:

The agitation/aggression is attributable to concomitant medications, environmental conditions, substance abuse, or active medical or psychiatric condition
Patient is receiving skilled nursing care for any medical condition other than dementia
Treatment with an antipsychotic medication within 2 weeks of Baseline visit or 5 half lives, whichever is longer
Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
Has had a myocardial infarction within the last six months
Has a history or symptoms of long QT syndrome
Has a history of a significant psychotic disorder before or during the diagnosis of probable Alzheimer's disease (including, but not limited to schizophrenia or bipolar disorder)
Patient is bedridden or has any significant medical condition that is unstable and would place the patient at undue risk from study drug or study procedures 9. Has a sensitivity to pimavanserin or its excipients

10. Has previously participated in a clinical study with pimavanserin

11. Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on Investigator's assessment of behavior within the last 3 months at Screening or since last visit at Baseline
Intervention: BEMPEDOIC ACID
Trial phase: Phase 3
ATC code: C10AX15 | C10BA10
SMILES: CC(C)(CCCCCC(O)CCCCCC(C)(C)C(=O)O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7001
Group description: Participants were administered with Bempedoic acid 180 mg tablet once daily orally.
Eligibility criteria:
Inclusion Criteria:

Age between 18 and 85 years
History of, or at high risk for, cardiovascular disease (CVD) including coronary artery disease, symptomatic peripheral arterial disease, cerebrovascular atherosclerotic disease, or at high risk for a cardiovascular event

Participant-reported SI due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued resulting in an inability to tolerate:

2 or more statins at any dose, or
1 statin at any dose and unwilling to attempt a second statin or advised by a physician to not attempt a second statin.

Please note that participants currently tolerating very low dose statin therapy (an average daily dose of rosuvastatin <5 mg, atorvastatin <10 mg, simvastatin <10 mg, lovastatin <20 mg, pravastatin <40 mg, fluvastatin <40 mg, or pitavastatin <2 mg) are considered to be intolerant to that low dose statin. Patients may continue taking very low dose statin therapy throughout the study provided that it is stable (used for at least 4 weeks prior to screening) and well tolerated.

Written confirmation by both participant and investigator that the participant is statin intolerant as defined above, aware of the benefit of statin use to reduce the risk of MACE including death, and also aware that many other participants who are unable to tolerate a statin are able to tolerate a different statin or dose.
Men and nonpregnant, nonlactating women
Fasting blood LDL-cholesterol ≥ 100 (2.6 mmol/L) at screening

Exclusion Criteria:

Fasting blood triglycerides greater than 500 mg/dL (5.6 mmol/L) at screening
Recent (within 90 days of screening) history of major cardiovascular events, transient ischemic attack (TIA), or unstable or symptomatic cardiac arrhythmia
History of severe heart failure
Uncontrolled hypertension or uncontrolled diabetes