anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Atorvastatin
Trial phase: Phase 2
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days

Atorvastatin injection: statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection
Eligibility criteria:
Inclusion Criteria:

On stable dose of daily oral atorvastatin for >= 5 weeks (oral atorvastatin may be provided during a lead-in period for subjects not previously taking atorvastatin)
Stable LDL-C confirmed in the previous 7 to 10 days prior to enrollment into the treatment phase.

Exclusion Criteria:

History of myopathy or rhabdomyolysis
Liver disease including current biliary disorders
Positive for HIV, Hepatitis B or Hepatitis C Virus
Abuse of alcohol or non-prescribed drugs
Unstable angina or arrhythmias or a cardiac event in the previous three months
hypothyroidism, diabetes, or hypertension that is not under control
pregnant or plans to be pregnant
Intervention: Atorvastatin
Trial phase: Phase 2
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days

Atorvastatin injection: statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection
Eligibility criteria:
Inclusion Criteria:

On stable dose of daily oral atorvastatin for >= 5 weeks (oral atorvastatin may be provided during a lead-in period for subjects not previously taking atorvastatin)
Stable LDL-C confirmed in the previous 7 to 10 days prior to enrollment into the treatment phase.

Exclusion Criteria:

History of myopathy or rhabdomyolysis
Liver disease including current biliary disorders
Positive for HIV, Hepatitis B or Hepatitis C Virus
Abuse of alcohol or non-prescribed drugs
Unstable angina or arrhythmias or a cardiac event in the previous three months
hypothyroidism, diabetes, or hypertension that is not under control
pregnant or plans to be pregnant
Intervention: Atorvastatin
Trial phase: Phase 2
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days

Atorvastatin injection: statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection
Eligibility criteria:
Inclusion Criteria:

On stable dose of daily oral atorvastatin for >= 5 weeks (oral atorvastatin may be provided during a lead-in period for subjects not previously taking atorvastatin)
Stable LDL-C confirmed in the previous 7 to 10 days prior to enrollment into the treatment phase.

Exclusion Criteria:

History of myopathy or rhabdomyolysis
Liver disease including current biliary disorders
Positive for HIV, Hepatitis B or Hepatitis C Virus
Abuse of alcohol or non-prescribed drugs
Unstable angina or arrhythmias or a cardiac event in the previous three months
hypothyroidism, diabetes, or hypertension that is not under control
pregnant or plans to be pregnant
Intervention: Semaglutide
Trial phase: Phase 3
ATC code: A10BJ06
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CC[C@@H](NC(=O)CCCCCCCCCCCCCCCCC(=O)O)C(=O)O)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(N)=O)NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)C(C)(C)NC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](C)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](C(=O)N[C@@H](CCCNC(=N)N)C(=O)NCC(=O)N[C@@H](CCCNC(=N)N)C(=O)NCC(=O)O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 407
Group description: Participants were to receive once-weekly subcutaneous (s.c) injection of semaglutide using a PDS290 pre-filled pen-injector with a 3 mL cartridge containing semaglutide 1.0 mg/mL or 3.0 mg/mL or 3.2 mg/mL in 16 week dose escalation period with dose escalation (0.25 mg, 0.5 mg, 1.0 mg and 1.7 mg) every fourth week until maintenance dose of 2.4 mg of semaglutide was reached. Treatment was continued on the maintenance dose of 2.4 mg once weekly for an additional 52 weeks until week 68. The treatment was an adjunct to Intensive Behavioural Therapy (IBT), which involves physical activity and dietary intervention with the first 8 weeks of a low-calorie diet (LCD) followed by a strict hypo-caloric diet till the end of treatment.
Eligibility criteria:
Inclusion Criteria:

Male or female, age more than or equal to 18 years at the time of signing informed consent
Body mass index more than or equal to 30 kg/m^2 or more than or equal to 27 kg/m^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
History of at least one self-reported unsuccessful dietary effort to lose body weight

Exclusion Criteria:

Hemoglobin A1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
Intervention: ASCORBIC ACID
Trial phase: Phase 2
ATC code: A11GA01 | A11GB01 | B03AA10 | G01AD03 | S01XA15
SMILES: O=C1OC(C(O)CO)C(O)=C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: All study participants will receive the same treatment. Each participant will be given intravenous, which means by vein (IV), vitamin C three times a day for 14 days. Then participants will take vitamin C orally (by mouth in pill form) twice a day each day until 6 months after transplant. The treatment is IV vitamin C 50 mg/kg/day. After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day.

Intravenous (IV) and oral Vitamin C: Intravenous (IV) vitamin C 50 mg/kg/day divided in 3 doses beginning on posttransplant Day +1 and continuing through Day +14; each dose (16.7 mg/kg) given in 50 mL of 5% dextrose and water over 30 minutes every 8 hours

• After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day beginning on Day +15 and continuing until Day +180
Eligibility criteria:
Inclusion Criteria:

A patient must meet all of the following inclusion criteria to be eligible to participate in the study:

Any of the following hematological malignancies:

Acute lymphoblastic leukemia
Acute myelogenous leukemia
Chronic myelogenous leukemia
Myelodysplasia
Candidate for hematopoietic cell transplant (HCT) Note: Patients with or without previous myeloablative autologous transplant are eligible.
human leukocyte antigen (HLA) matched stem cell donor, either related (6/6 or 5/6 loci matched) or unrelated (8/8 or 7/8 loci matched)
Stem cell graft from either bone marrow or peripheral blood
Negative serology for HIV
Age ≥ 18 to < 78 years of age
Karnofsky Performance Status of 70-100%
Women who are not postmenopausal or have not undergone hysterectomy must have a documented negative serum pregnancy test per standard Massey Cancer Center- Virginia Commonwealth University Health System (MCC-VCUHS) Bone Marrow Transplant (BMT) Program guidelines
Ability to understand and the willingness to sign a written informed consent document. Note: The consent form must be signed and dated prior to initiation of stem cell transplant (SCT) preparative treatments.

Exclusion Criteria:

A patient who meets any of the following exclusion criteria is ineligible to participate in the study.

Known allergy to vitamin C
Inability to swallow oral medication
Known or suspected malabsorption condition or obstruction
G6PDH deficiency
Uncontrolled viral, fungal, or bacterial infection
Active meningeal or central nervous system disease
Alternative hematopoietic cell transplant (HCT) including haplo-identical and umbilical cord transplants
Non-myeloablative conditioning defined as total body irradiation (TBI) < 2 centigray (cGy)
Pregnancy or breastfeeding
Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Intervention: Rapastinel
Trial phase: Phase 3
SMILES: CC(O)C(N)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(C(N)=O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
Eligibility criteria:
Inclusion Criteria: -

Completion of Study RAP-MD-30, RAP-MD-31, or RAP-MD-32
If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test

Exclusion Criteria: -

DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
Lifetime history of meeting DSM-5 criteria for:
1.Schizophrenia spectrum or other psychotic disorder
2.Bipolar or related disorder
3.Major neurocognitive disorder
4.Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
5.Dissociative disorder
6.Posttraumatic stress disorder
7.MDD with psychotic features
Significant suicide risk, as judged by the Investigator
Intervention: Rapastinel
Trial phase: Phase 3
SMILES: CC(O)C(N)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(C(N)=O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 55
Group description: Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration)
Eligibility criteria:
Inclusion Criteria: -

Completion of Study RAP-MD-30, RAP-MD-31, or RAP-MD-32
If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test

Exclusion Criteria: -

DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
Lifetime history of meeting DSM-5 criteria for:
1.Schizophrenia spectrum or other psychotic disorder
2.Bipolar or related disorder
3.Major neurocognitive disorder
4.Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
5.Dissociative disorder
6.Posttraumatic stress disorder
7.MDD with psychotic features
Significant suicide risk, as judged by the Investigator
Intervention: Phenylephrine
Trial phase: Phase 4
ATC code: C01CA06 | R01AA04 | R01AB01 | R01BA03 | R01BA53 | S01FB01 | S01FB51 | S01GA05 | S01GA55
SMILES: CNC[C@H](O)c1cccc(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1
Group description: All patients will receive 10% phenylephrine at their eye examination as the drug to dilate the pupil. After pupil dilation, pupil size will be measured.

10% phenylephrine: 10% phenylephrine is a drug that can be used to dilate patient's eyes at their yearly eye examination. All enrolled subjects will receive this drug for their eye dilation.
Eligibility criteria:
Inclusion Criteria:

Horner's Syndrome
History of taking an alpha blocker (tamsulosin/ terazosin/doxazosin/alfuzosin/silodosin) medication

Exclusion Criteria:

Subjects with untreated hypertension
Subjects with thyrotoxicosis
Pregnant women
Prisoners
Inability to consent
Subjects with anatomical narrow angles who have never had a dilated exam
Intervention: Magnesium Sulfate
Trial phase: Not Applicable
ATC code: A06AD04 | A12CC02 | B05XA05 | D11AX05 | V04CC02
SMILES: O=S(=O)([O-])[O-].[Mg+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 37
Group description: Receiving Magnesium Sulfate

Magnesium Sulfate
Eligibility criteria:
Inclusion Criteria:

Age >18 years old and <100 years old.
Patients seen in the Emergency Department at Henry Ford Macomb hospital.
Patients that are A+Ox3.
Patients who have typical presentation for renal colic.

Exclusion Criteria:

Age <18 years.
Patients with a history of dementia, acute delirium or altered mental status.
Patients with inability to consent to study or inability to fill questionnaire independently.
Patients with chronic kidney disease and allergies to study drugs.
Patients that are pregnant (women who are of child-bearing potential will be screened with a urine BHCG).
Patients with stroke activation or symptoms.
Patients with trauma activations.
Patients over the age of 100 years old are excluded as they make up a small percentage of the population and may become identifiable because of their age.
Imaging study does not show evidence of ureteral stone.
Intervention: Difelikefalin
Trial phase: Phase 2
ATC code: V03AX04
SMILES: CC(C)C[C@@H](NC(=O)[C@@H](Cc1ccccc1)NC(=O)[C@H](N)Cc1ccccc1)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: Oral CR845 0.25 mg to be taken orally once daily for 12 weeks

CR845 0.25 mg Oral Tablet: CR845 0.25 mg medication taken orally 1 time/day
Eligibility criteria:
Inclusion Criteria:

To be eligible for inclusion into the study, a patient must meet the following criteria:

CKD patients with stage III, IV, or V (ie, moderate renal impairment with estimated glomerular filtration rate (GFR) ≥30 and <60 mL/min/1.73 m2 or severe renal impairment with estimated GFR <30 mL/min/1.73 m2).
For severe CKD patients on hemodialysis, they must be receiving hemodialysis 3 times per week for at least 3 months prior to the start of screening;

Prior to randomization:

Has completed at least 4 Worst Itching Intensity NRS worksheets from the start of the 7-day Run-in Period;
Has a mean baseline Worst Itching Intensity NRS score ≥5, defined as the average of all non-missing scores reported from the start of the 7-day Run-in Period.

Exclusion Criteria:

A patient will be excluded from the study if any of the following criteria are met:

Patients not currently on dialysis who are likely to initiate routine dialysis during study participation;
Scheduled to receive a kidney transplant during the study;
New or change of treatment received for itch including antihistamines and corticosteroids (oral, intravenous [IV], or topical) within 14 days prior to screening;
Received another investigational drug within 30 days prior to the start of screening or is planning to participate in another clinical study while enrolled in this study;
Received ultraviolet B treatment within 30 days prior to the start of screening or anticipates receiving such treatment during the study;
Participated in a previous clinical study with CR845.
Intervention: Difelikefalin
Trial phase: Phase 2
ATC code: V03AX04
SMILES: CC(C)C[C@@H](NC(=O)[C@@H](Cc1ccccc1)NC(=O)[C@H](N)Cc1ccccc1)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: Oral CR845 0.5 mg to be taken orally once daily for 12 weeks

CR845 0.5 mg Oral Tablet: CR845 0.5 mg medication taken orally 1 time/day
Eligibility criteria:
Inclusion Criteria:

To be eligible for inclusion into the study, a patient must meet the following criteria:

CKD patients with stage III, IV, or V (ie, moderate renal impairment with estimated glomerular filtration rate (GFR) ≥30 and <60 mL/min/1.73 m2 or severe renal impairment with estimated GFR <30 mL/min/1.73 m2).
For severe CKD patients on hemodialysis, they must be receiving hemodialysis 3 times per week for at least 3 months prior to the start of screening;

Prior to randomization:

Has completed at least 4 Worst Itching Intensity NRS worksheets from the start of the 7-day Run-in Period;
Has a mean baseline Worst Itching Intensity NRS score ≥5, defined as the average of all non-missing scores reported from the start of the 7-day Run-in Period.

Exclusion Criteria:

A patient will be excluded from the study if any of the following criteria are met:

Patients not currently on dialysis who are likely to initiate routine dialysis during study participation;
Scheduled to receive a kidney transplant during the study;
New or change of treatment received for itch including antihistamines and corticosteroids (oral, intravenous [IV], or topical) within 14 days prior to screening;
Received another investigational drug within 30 days prior to the start of screening or is planning to participate in another clinical study while enrolled in this study;
Received ultraviolet B treatment within 30 days prior to the start of screening or anticipates receiving such treatment during the study;
Participated in a previous clinical study with CR845.
Intervention: Difelikefalin
Trial phase: Phase 2
ATC code: V03AX04
SMILES: CC(C)C[C@@H](NC(=O)[C@@H](Cc1ccccc1)NC(=O)[C@H](N)Cc1ccccc1)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 67
Group description: Oral CR845 1 mg to be taken orally once daily for 12 weeks

CR845 1 mg Oral Tablet: CR845 1 mg medication taken orally 1 time/day
Eligibility criteria:
Inclusion Criteria:

To be eligible for inclusion into the study, a patient must meet the following criteria:

CKD patients with stage III, IV, or V (ie, moderate renal impairment with estimated glomerular filtration rate (GFR) ≥30 and <60 mL/min/1.73 m2 or severe renal impairment with estimated GFR <30 mL/min/1.73 m2).
For severe CKD patients on hemodialysis, they must be receiving hemodialysis 3 times per week for at least 3 months prior to the start of screening;

Prior to randomization:

Has completed at least 4 Worst Itching Intensity NRS worksheets from the start of the 7-day Run-in Period;
Has a mean baseline Worst Itching Intensity NRS score ≥5, defined as the average of all non-missing scores reported from the start of the 7-day Run-in Period.

Exclusion Criteria:

A patient will be excluded from the study if any of the following criteria are met:

Patients not currently on dialysis who are likely to initiate routine dialysis during study participation;
Scheduled to receive a kidney transplant during the study;
New or change of treatment received for itch including antihistamines and corticosteroids (oral, intravenous [IV], or topical) within 14 days prior to screening;
Received another investigational drug within 30 days prior to the start of screening or is planning to participate in another clinical study while enrolled in this study;
Received ultraviolet B treatment within 30 days prior to the start of screening or anticipates receiving such treatment during the study;
Participated in a previous clinical study with CR845.
Intervention: Dapagliflozin
Trial phase: Phase 3
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3126
Group description: Dapagliflozin 10 mg tablets administered once daily per oral use
Eligibility criteria:
Inclusion Criteria:

Provision of signed informed consent prior to any study specific procedures.
Male or female patients age ≥40 years.
Documented diagnosis of symptomatic heart failure (NYHA class II-IV) at enrolment, and a medical history of typical symptoms/signs of heart failure ≥6 weeks before enrolment with at least intermittent need for diuretic treatment.
Left Ventricular Ejection Fraction (LVEF) >40% and evidence of structural heart disease (i.e. left ventricular hypertrophy or left atrial enlargement ) documented by the most recent echocardiogram, and/or cardiac MR within the last 12 months prior to enrolment. For patients with prior acute cardiac events or procedures that may reduce LVEF, e.g. as defined in exclusion criterion 6, qualifying cardiac imaging assessment at least 12 weeks following the procedure/event is required.
Elevated NT-pro BNP levels.
Both ambulatory and hospitalised patients may be enrolled and randomised. Patients currently hospitalised for HF, must be off intravenous HF medications for at least 24 before randomisation.

Further details regarding inclusion criteria 4-6 may apply.

Exclusion Criteria:

Receiving therapy with an SGLT2 inhibitor within 4 weeks prior to randomisation or previous intolerance to an SGLT2 inhibitor.
Type 1 diabetes mellitus (T1D).
eGFR <25 mL/min/1.73 m2 (CKD-EPI formula) at Visit 1.
Systolic blood pressure (BP) <95 mmHg on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
Systolic BP≥160 mmHg if not on treatment with ≥3 blood pressure lowering medications or ≥180 mmHg irrespective of treatments, on 2 consecutive measurements at 5-minute intervals, at Visit 1 or at Visit 2.
MI, unstable angina, coronary revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)), ablation of atrial flutter/fibrillation, valve repair/replacement within 12 weeks prior to enrolment. Before enrolment, these patients must have their qualifying echocardiography and/or cardiac MRI examination at least 12 weeks after the event.
Planned coronary revascularization, ablation of atrial flutter/fibrillation and valve repair/replacement.
Stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment.
Probable alternative or concomitant diagnoses which in the opinion of the investigator could account for the patient's HF symptoms and signs (e.g. anaemia, hypothyroidism).
Body mass index >50 kg/m2.

Further exclusion criteria may apply