anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Filorexant
Trial phase: Phase 2
SMILES: Cc1ccc(-c2ncccn2)c(C(=O)N2C[C@H](COc3ccc(F)cn3)CC[C@H]2C)c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 64
Group description: Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Participant is (a) male or (b) female and not of reproductive potential, or (c) female of reproductive potential has a serum beta-hCG level consistent with the nongravid state at screening and agrees to use acceptable contraception;
Current primary diagnosis of recurrent major depressive disorder, without psychotic features, with a current moderate or severe depressive episode;
Duration of the current major depressive episode must be at least 2 months but no more than 18 months at Screening;
Participant has undergone an adequate trial of an antidepressant (one of identified SSRIs or SNRIs, or bupropion) for the current depressive episode.

Key Exclusion Criteria:

Current primary psychiatric diagnosis other than major depression;
Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychotic disorder;
Alcohol or other substance abuse or dependence (excluding nicotine);
Clinically significant abnormality or disease of the central nervous system (including dementia and other cognitive disorders or traumatic brain injury);
Imminent risk of self-harm or of harm to others;
Participant is a psychiatric inpatient;
Participant has been on continuous antidepressant treatment for >18 months prior to Screening visit;
Inadequate response to more than 3 adequate antidepressant trials (including the current antidepressant treatment trial) for treatment of the current depressive episode;
Participant ever received electroconvulsive therapy, transcranial magnetic stimulation, or vagal nerve stimulation for treatment of depression;
History of narcolepsy, cataplexy, circadian rhythm disorder, parasomnia, sleep-related breathing disorder, restless legs syndrome, periodic limb movement disorder, excessive daytime sleepiness or difficulty sleeping due to a medical condition;
Clinical, laboratory, or electrocardiogram (ECG) evidence of significant systemic disease;
Cardiovascular event (e.g., myocardial infarction) or procedure (e.g., coronary artery bypass surgery) within 3 months of study;
History of malignancy ≤5 years prior to study, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer;
Body Mass Index >40 kg/m^2;
Pregnancy, breast-feeding, or expecting to become pregnant.
Intervention: Filorexant
Trial phase: Phase 2
SMILES: Cc1ccc(-c2ncccn2)c(C(=O)N2C[C@H](COc3ccc(F)cn3)CC[C@H]2C)c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
Eligibility criteria:
Inclusion Criteria:

Participant is (a) male or (b) female and not of reproductive potential, or (c) female of reproductive potential has a serum beta-hCG level consistent with the nongravid state at screening and agrees to use acceptable contraception;
Current primary diagnosis of recurrent major depressive disorder, without psychotic features, with a current moderate or severe depressive episode;
Duration of the current major depressive episode must be at least 2 months but no more than 18 months at Screening;
Participant has undergone an adequate trial of an antidepressant (one of identified SSRIs or SNRIs, or bupropion) for the current depressive episode.

Key Exclusion Criteria:

Current primary psychiatric diagnosis other than major depression;
Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychotic disorder;
Alcohol or other substance abuse or dependence (excluding nicotine);
Clinically significant abnormality or disease of the central nervous system (including dementia and other cognitive disorders or traumatic brain injury);
Imminent risk of self-harm or of harm to others;
Participant is a psychiatric inpatient;
Participant has been on continuous antidepressant treatment for >18 months prior to Screening visit;
Inadequate response to more than 3 adequate antidepressant trials (including the current antidepressant treatment trial) for treatment of the current depressive episode;
Participant ever received electroconvulsive therapy, transcranial magnetic stimulation, or vagal nerve stimulation for treatment of depression;
History of narcolepsy, cataplexy, circadian rhythm disorder, parasomnia, sleep-related breathing disorder, restless legs syndrome, periodic limb movement disorder, excessive daytime sleepiness or difficulty sleeping due to a medical condition;
Clinical, laboratory, or electrocardiogram (ECG) evidence of significant systemic disease;
Cardiovascular event (e.g., myocardial infarction) or procedure (e.g., coronary artery bypass surgery) within 3 months of study;
History of malignancy ≤5 years prior to study, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer;
Body Mass Index >40 kg/m^2;
Pregnancy, breast-feeding, or expecting to become pregnant.
Intervention: Gefapixant
Trial phase: Phase 2
ATC code: G01AE10 | R05DB29
SMILES: COc1cc(C(C)C)c(Oc2cnc(N)nc2N)cc1S(N)(=O)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Men or women
Women of child bearing potential must not be pregnant during the study and must use two forms of birth control
Men and their female partners must use two forms of birth control
Clinical and radiographic evidence of chronic knee osteoarthritis
An average NPRS score of >=5 and <=9 over a 4-7 day washout period of their previous osteoarthritis medications
Ambulatory
Have provided written informed consent
Intervention: Ferric citrate
Trial phase: Phase 3
ATC code: V03AE08
SMILES: O=C([O-])CC(O)(CC(=O)[O-])C(=O)[O-].[Fe+3]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 166
Group description: ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
Eligibility criteria:
Inclusion Criteria:

Males or non-pregnant, non-breast-feeding females who participated in the Safety Assessment Period (SAP), and if eligible, the Efficacy Assessment Period (EAP) of Study KRX-0502-304
Willing and able to give informed consent

Exclusion Criteria:

Subjects on KRX-0502 (ferric citrate) in KRX-0502-304 who were treatment failures in first period
Any subject in Study KRX-0502-304 SAP who early terminated from the trial
Any subject who participated in Study KRX-0502-304 but declined EAP
Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease
History of malignancy in the last five years
Previous intolerance to KRX-0502 (ferric citrate)
Intolerance to oral iron-containing products
Absolute requirement for oral iron therapy
Absolute requirement for Vitamin C (multivitamins [Nephrocaps, Renaphro, etc.] allowed)
Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals
Inability to tolerate oral drug intake
Any other medical condition that rendered the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
Inability to cooperate with study personnel or history of noncompliance
Unsuitable for this trial per Principal Investigator's (PI) clinical judgment.
Intervention: Indacaterol
Trial phase: Phase 4
ATC code: R03AC18 | R03AK14 | R03AL04 | R03AL12
SMILES: CCc1cc2c(cc1CC)CC(NC[C@H](O)c1ccc(O)c3[nH]c(=O)ccc13)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 293
Group description: Indacaterol 150 μg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
Eligibility criteria:
Inclusion Criteria:

Patients with moderate COPD (Stage II)
Able to perform spirometry assessments
Current or ex-smokers
On treatment with the fixed-dose combination of salmeterol 50 µg/fluticasone propionate 500 µg MDDPI b.i.d. for the treatment of COPD for ≥ 3 months directly preceding Visit 1.

Exclusion Criteria:

Having had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the past year.
Having a history of, or current ECG abnormality
Asthma

Other protocol-defined inclusion/exclusion criteria may apply.
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: 11
Group description: Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer

Ascorbic Acid: 3x per week
Eligibility criteria:
Inclusion Criteria:

Males and females of age ≥ 18
Histologically or cytologically confirmed pancreatic adenocarcinoma that has metastatic disease measurable by CT, MRI, or PET
Subjects with unresectable pancreatic cancer who have had surgery (exploratory laparotomy, biliary, gastrointestinal bypass) are eligible, if the subject has fully recovered from surgery and ≥ 14 days has passed since the operation. Patients with history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence.
ECOG performance status 0-2
Laboratory values that would not prevent the patient from receiving chemotherapy as determined by the PI or study oncologist
G6PD status ≥ lower limit of normal
Serum creatinine ≤ 2.0 mg/dL

Exclusion Criteria:

Islet cell or acinar cell carcinoma or cystadenocarcinoma
History or known presence of central nervous system (CNS) metastases
History of another primary cancer, except:
Curatively treated cervical carcinoma in situ, or
Curatively resected non-melanomatous skin cancer, or
Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 3 years prior to enrollment
Other concurrent anticancer chemotherapy
Prior radiotherapy ≤ 14 days, or if subjects have not recovered from radiotherapy
Uncontrolled seizure disorder or other serious neurological diseases
Any co-morbid disease that would increase risk of toxicity as determined by PI
Only locally advanced disease
Prior treatment with gemcitabine (for metastatic pancreatic cancer)
Subjects requiring chronic use of immunosuppressive agents (eg, methotrexate, cyclosporine, corticosteroids)
Recent infection requiring a course of systemic anti-infection that was completed ≤ 14 days prior to enrollment (exception can be made at the judgment of the PI for oral treatment of an uncomplicated urinary tract infection ([UTI])
History of any medical or psychiatric condition or addictive disorder, or laboratory abnormality that, in the opinion of the PI, may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study requirements
Subject unwilling or unable to comply with study requirements
Subject who is pregnant or breast feeding
Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
Documented history of alcohol, cocaine or intravenous drug abuse ≤ 6 months of enrollment
Intervention: Memantine
Trial phase: Phase 1 | Phase 2
ATC code: N06DA52 | N06DA53 | N06DX01
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 80
Group description: Memantine: Each participant receives a single pill of placebo or active drug (memantine, 10 or 20 mg) and completes about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
Eligibility criteria:
Inclusion Criteria:

A diagnosis of schizophrenia or schizoaffective disorder - depressed type

Exclusion Criteria:

Age range,
Current alcohol or drug abuse
Intervention: Norgestrel
Trial phase: Phase 4
ATC code: G03AA06 | G03FA10 | G03FB01
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Placement within 48 hours of delivery

Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery
Eligibility criteria:
Women ages 18-45
Pregnant and equal to or more than 24 weeks of estimated gestational age
States an intent to breastfeed for at least 6 months
States a plan to use the LNG-IUS postpartum
Anticipates a vaginal delivery
HIV negative
Intend to stay in the Chapel Hill area for at least 6 months after birth
No medical or personal conditions which in the judgment of study staff preclude participation in the study
Have no allergies to any component of the LNG-IUS
No known uterine anomalies
Fluent in English
No history of ectopic pregnancy
No known or suspected carcinoma of the breast
No known acute liver disease or liver tumor (benign or malignant)
No known or suspected uterine or cervical neoplasia or unresolved abnormal pap smear
No active pelvic inflammatory disease
No known hypersensitivity to any component of the LNG-IUS
No genital bleeding of unknown etiology
No history of solid organ transplantation

Additional eligibility criteria for entry into the randomized trial, as assessed postpartum

No endometritis or chorioamnionitis
Membranes ruptured for less than 24 hours prior to delivery (O'Hanley, Hayes)
No fever greater than or equal to 38°C during the intrapartum or postpartum period
Did not receive medications other than pitocin and/or misoprostol to control postpartum bleeding
Did not have a documented estimated blood loss of greater than 750mL intrapartum
Did not receive a blood transfusion for a diagnosis of postpartum hemorrhage
Did not have a third or fourth degree laceration at delivery.
The infant must be greater than 35 weeks EGA at birth as determined by physical exam at birth
The infant must weigh at least 2727 grams
Must have been a singleton birth
Infant not in the intensive care nursery
The infant has not been diagnosed with a condition which would preclude long term feeding
Intervention: Norgestrel
Trial phase: Phase 4
ATC code: G03AA06 | G03FA10 | G03FB01
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Placement 4-8 weeks after delivery

Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery
Eligibility criteria:
Women ages 18-45
Pregnant and equal to or more than 24 weeks of estimated gestational age
States an intent to breastfeed for at least 6 months
States a plan to use the LNG-IUS postpartum
Anticipates a vaginal delivery
HIV negative
Intend to stay in the Chapel Hill area for at least 6 months after birth
No medical or personal conditions which in the judgment of study staff preclude participation in the study
Have no allergies to any component of the LNG-IUS
No known uterine anomalies
Fluent in English
No history of ectopic pregnancy
No known or suspected carcinoma of the breast
No known acute liver disease or liver tumor (benign or malignant)
No known or suspected uterine or cervical neoplasia or unresolved abnormal pap smear
No active pelvic inflammatory disease
No known hypersensitivity to any component of the LNG-IUS
No genital bleeding of unknown etiology
No history of solid organ transplantation

Additional eligibility criteria for entry into the randomized trial, as assessed postpartum

No endometritis or chorioamnionitis
Membranes ruptured for less than 24 hours prior to delivery (O'Hanley, Hayes)
No fever greater than or equal to 38°C during the intrapartum or postpartum period
Did not receive medications other than pitocin and/or misoprostol to control postpartum bleeding
Did not have a documented estimated blood loss of greater than 750mL intrapartum
Did not receive a blood transfusion for a diagnosis of postpartum hemorrhage
Did not have a third or fourth degree laceration at delivery.
The infant must be greater than 35 weeks EGA at birth as determined by physical exam at birth
The infant must weigh at least 2727 grams
Must have been a singleton birth
Infant not in the intensive care nursery
The infant has not been diagnosed with a condition which would preclude long term feeding
Intervention: Rasagiline
Trial phase: Phase 3
ATC code: N04BD02
SMILES: C#CCN[C@@H]1CCc2ccccc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 65
Group description: rasagiline: 1 mg/day, tablets, once daily, orally
Eligibility criteria:
Inclusion Criteria:

Patients with idiopathic PD.
Patients with a Modified Hoehn and Yahr stage <3.

Exclusion Criteria:

Patients with a clinically significant or unstable medical or surgical condition that would preclude his/her safe and complete study participation.
Patients with a clinically significant or unstable vascular disease.
Patients with a clinically significant psychiatric illness, including a major depression, which compromises their ability to provide consent or participate fully in the study.
Patients with a Mini Mental State Examination (MMSE) score ≤24.
Patients with a diagnosis of melanoma or a history of melanoma, or a suspicious lesion.

Other inclusion and exclusion criteria may apply.
Intervention: Naltrexone
Trial phase: Phase 2
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: 25
Group description: The VIVITROL group will be offered one injection of VIVITROL every 4 weeks. Participants in the VIVITROL group will be required to take their scheduled injections to work and earn wages. If a participant misses a scheduled VIVITROL injection (more than 3 days from the scheduled date of administration), the participant will not be allowed to work until the injection is accepted. Additionally, missing a scheduled injection will result in a base pay reset from $8 per hour to $1 per hour. After the reset, the participant's base pay will increase by $1/hour to the maximum of $8/hour for every day that the participant works at least 5 minutes.

Vivitrol: Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks.
Eligibility criteria:
Inclusion Criteria:

meet the DSM-IV criteria for opioid dependence,
report using heroin at least 21 of the last 30 days while living in the community,
are unemployed,
are 18-65 years old,
are medically approved for naltrexone,
live in or near Baltimore, MD.

Exclusion Criteria:

have current DSM-IV major Axis I disorders
have current suicidal or homicidal ideation
express interest in methadone treatment
are required to use opioids for medical purposes
earned over $200 in taxable income over the previous 30 days while living in the community
have physical limitations that prevent them from using a keyboard
are pregnant or breastfeeding
have serum aminotransferase levels over three times normal
have known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or poly (lactide-co-glycolide) (PLG) or any other components of the diluents;
are participating in any other clinical study.
Intervention: Ropivacaine
Trial phase: Not Applicable
ATC code: N01BB09
SMILES: CCCN1CCCC[C@H]1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: 0.1% ropivacaine

Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2.
Eligibility criteria:
Inclusion Criteria:

Age 18-75 years old
American Society of Anesthesiologists physical status score I-III
Scheduled for primary total hip arthroplasty at UPMC Shadyside Hospital in Pittsburgh, PA.
No contraindications to peripheral nerve catheter placement
Patients not expected to receive therapeutic anticoagulation in the postoperative period.
No known drug allergies to study medications
Patients willing to receive spinal anesthesia as operative anesthetic

Exclusion Criteria:

Age under 18 years or older than 75 years.
Any contraindication to a placement of continuous lumbar plexus peripheral nerve catheter.
American Society of Anesthesiologist physical status IV or greater.
Chronic painful conditions.
Preoperative opioid tolerant use (opioid use for greater than 6 contiguous months before surgery).
Coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively.
Allergy to any of the drugs/agents used study protocol.
Pregnancy
Having an altered mental status (not oriented to place, person, or time)
Any comorbid condition that, in the judgment of the consulting orthopedic surgeon or intraoperative anesthesiologist, would proscribe the patient from any aspect of the study.
Patient refusal.
Patient requiring postoperative management in the ICU
Lumbar plexus catheter placed by loss of resistance technique.
Intervention: Coversyl
Trial phase: Phase 3
SMILES: CC(C)(C)N.CCCC(NC(C)C(=O)N1C(C(=O)O)CC2CCCCC21)C(=O)OCC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 278
Group description: Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
Eligibility criteria:
Inclusion Criteria:

Essential hypertension
For female subjects, a negative serum pregnancy test
Ability to provide written informed consent

Exclusion Criteria:

Night shift workers whose work hours include midnight to 4:00 a.m.
Secondary hypertension
An arm size that precludes the use of the digital blood pressure monitor cuff (arm size > 42 cm)
Renal dysfunction, severe renal impairment, bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, subjects with only 1 kidney, or post-renal transplant subjects
Female subjects who are pregnant, planning to become pregnant
History of malignancy within 5 years
Primary aldosteronism
Heart failure (NYHA functional class 3-4), hypertrophic obstructive cardiomyopathy, or hemodynamically relevant stenosis of the aortic or mitral valve
Significant cardiac arrhythmias, MI, stroke, CABG, PTCA, unstable angina
Known hypersensitivity to any component of the study drugs

Other protocol-defined inclusion/exclusion criteria may apply