anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Oliceridine
Trial phase: Phase 3
ATC code: N02AX07
SMILES: COc1ccsc1CNCC[C@@]1(c2ccccn2)CCOC2(CCCC2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 80
Group description: Oliceridine 0.35 mg
Eligibility criteria:
Inclusion Criteria:

Has undergone abdominoplasty with no additional collateral procedures.
Experiences a pain intensity rating of moderate to severe acute pain.
Able to provide written informed consent before any study procedure.

Exclusion Criteria:

ASA Physical Status Classification System classification of P3 or worse.
Has surgical or post-surgical complications.
Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.
Has previously participated in another TRV130 clinical study.
Intervention: Oliceridine
Trial phase: Phase 3
ATC code: N02AX07
SMILES: COc1ccsc1CNCC[C@@]1(c2ccccn2)CCOC2(CCCC2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 80
Group description: Oliceridine 0.5 mg
Eligibility criteria:
Inclusion Criteria:

Has undergone abdominoplasty with no additional collateral procedures.
Experiences a pain intensity rating of moderate to severe acute pain.
Able to provide written informed consent before any study procedure.

Exclusion Criteria:

ASA Physical Status Classification System classification of P3 or worse.
Has surgical or post-surgical complications.
Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.
Has previously participated in another TRV130 clinical study.
Intervention: Morphine
Trial phase: Phase 3
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 83
Group description: Morphine
Eligibility criteria:
Inclusion Criteria:

Has undergone abdominoplasty with no additional collateral procedures.
Experiences a pain intensity rating of moderate to severe acute pain.
Able to provide written informed consent before any study procedure.

Exclusion Criteria:

ASA Physical Status Classification System classification of P3 or worse.
Has surgical or post-surgical complications.
Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.
Has previously participated in another TRV130 clinical study.
Intervention: Flecainide
Trial phase: Phase 2
ATC code: C01BC04
SMILES: O=C(NCC1CCCCN1)c1cc(OCC(F)(F)F)ccc1OCC(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Treatment B : THN102 300/3 Modafinil 300 mg/d Flecainide 3 mg/d Duration : 2 weeks
Eligibility criteria:
Main inclusion Criteria:

Patients with a diagnosis of narcolepsy type 1 (i.e. with cataplexy) or type 2 (without cataplexy) according to the International Classification of Sleep Disorders (ICSD-3) criteria.
Body mass index >18 kg/m2 and <35 kg/m2.
Patients treated with modafinil at stable dosage for at least 2 months and still complaining of excessive daily somnolence (EDS) despite the treatment
Epworth Sleepiness Scale (ESS) score should be ≥ 14/24 during the baseline period.

Main exclusion Criteria:

Patients with an untreated sleep apnea syndrome (respiratory disorder index > 30/h) or who have any other cause of daytime sleepiness as assessed on patient history.
Psychiatric and neurological disorders, other than narcolepsy/cataplexy, such as Parkinson's disease, Alzheimer's disease, Huntington's Chorea, multiple sclerosis, moderate or severe psychosis or dementia, bipolar illness, epilepsy, severe clinical anxiety or depression, Beck Depression Inventory ≥ 21 or with suicidal risk (if item > 0), or other problem that in the investigator's opinion would preclude the patient's participation and completion of this trial or comprise reliable representation of subjective symptoms.
Contraindication to flecainide
Intervention: Flecainide
Trial phase: Phase 2
ATC code: C01BC04
SMILES: O=C(NCC1CCCCN1)c1cc(OCC(F)(F)F)ccc1OCC(F)(F)F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Treatment C : THN102 300/27 Modafinil 300 mg/d Flecainide 27 mg/d Duration : 2 weeks
Eligibility criteria:
Main inclusion Criteria:

Patients with a diagnosis of narcolepsy type 1 (i.e. with cataplexy) or type 2 (without cataplexy) according to the International Classification of Sleep Disorders (ICSD-3) criteria.
Body mass index >18 kg/m2 and <35 kg/m2.
Patients treated with modafinil at stable dosage for at least 2 months and still complaining of excessive daily somnolence (EDS) despite the treatment
Epworth Sleepiness Scale (ESS) score should be ≥ 14/24 during the baseline period.

Main exclusion Criteria:

Patients with an untreated sleep apnea syndrome (respiratory disorder index > 30/h) or who have any other cause of daytime sleepiness as assessed on patient history.
Psychiatric and neurological disorders, other than narcolepsy/cataplexy, such as Parkinson's disease, Alzheimer's disease, Huntington's Chorea, multiple sclerosis, moderate or severe psychosis or dementia, bipolar illness, epilepsy, severe clinical anxiety or depression, Beck Depression Inventory ≥ 21 or with suicidal risk (if item > 0), or other problem that in the investigator's opinion would preclude the patient's participation and completion of this trial or comprise reliable representation of subjective symptoms.
Contraindication to flecainide
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Participants randomized to this arm will undergo uroflow studies then be given a 2-hour rest. Urodynamics with the use of Urojet (lidocaine hydrochloride 2%) will then be performed. The lidocaine gel will be placed in and around the urethra. It will be allowed to set for 3 minutes, then the remainder of the standard urodynamic evaluation will be performed. We are using Urojet (lidocaine gel) in an FDA approved manner (for analgesia).

lidocaine gel
Eligibility criteria:
Inclusion Criteria:

Females ages 18-60 years
No health conditions as indicated in exclusion criteria
Able to provide informed consent and agree to the risks of the study
Willing to abstain from caffeine and alcohol for 24 hours
Willing to avoid taking anticholinergic medications (for reasons other than incontinence; e.g., diphenhydramine) for one week prior to the procedure

Exclusion Criteria:

Pelvic organ prolapse past the hymen
Multiple sclerosis, myasthenia gravis, Parkinson's Disease, stroke within the past 6 months
Interstitial cystitis / Bladder Pain Syndrome
Recurrent (≥ 3/year) urinary tract infections
Positive pregnancy test at the time of consent
≤ 6 weeks postpartum or if breastfeeding
Positive urine dip (>+1nitrites or >1+LE) and urinary symptoms at the time of consent
>1+ blood on urinary dip
Morbid obesity (BMI >40)
Taking anticholinergic medications for urinary incontinence
>2 replies of ≥ "sometimes" on the Lower Urinary Tract Symptoms questionnaire at the time of consent
Intervention: Rivaroxaban
Trial phase: Phase 2 | Phase 3
ATC code: B01AF01
SMILES: O=C(NC[C@H]1CN(c2ccc(N3CCOCC3=O)cc2)C(=O)O1)c1ccc(Cl)s1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Rivaroxaban: 15mg BID for 7 days, then 20mg daily for three months
Eligibility criteria:
Inclusion Criteria:

Non-pregnant women, age 18-50

For study purposes, evidence of negative pregnancy is accounted for by the treating physician's initiation of treatment with oral anticoagulants
Objectively diagnosed VTE or atrial fibrillation/flutter
Patient reported active menstruation - does not apply to women who were recently pregnant
Clinical plan and patient agreement to treat with oral anticoagulation for 3 months or longer
Patients must have a working telephone

Exclusion Criteria:

Package insert exclusions for Eliquis (Apixban) or Xarelto (Rivaroxaban): [active pathological bleeding or severe hypersensitivity reaction to XARELTO or ELIQUIS (e.g., anaphylactic reactions)]
Plan to become pregnant in the next three months.
Concomitant prescribed use of aspirin or thienopyridenes or other platelet inhibiting drugs
Plan for surgical hysterectomy or endometrial ablation
Known uterine cancer
Von Willebrand's disease, or hemophilia
Known coagulopathy from liver disease
Conditions likely to preclude adherence to study procedures: Active intravenous drug use, known alcoholism, homelessness, or uncontrolled psychiatric illness.
Intervention: Apixaban
Trial phase: Phase 2 | Phase 3
ATC code: B01AF02
SMILES: COc1ccc(-n2nc(C(N)=O)c3c2C(=O)N(c2ccc(N4CCCCC4=O)cc2)CC3)cc1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Apixaban: 10mg BID for 7 days, then 5mg BID for three months
Eligibility criteria:
Inclusion Criteria:

Non-pregnant women, age 18-50

For study purposes, evidence of negative pregnancy is accounted for by the treating physician's initiation of treatment with oral anticoagulants
Objectively diagnosed VTE or atrial fibrillation/flutter
Patient reported active menstruation - does not apply to women who were recently pregnant
Clinical plan and patient agreement to treat with oral anticoagulation for 3 months or longer
Patients must have a working telephone

Exclusion Criteria:

Package insert exclusions for Eliquis (Apixban) or Xarelto (Rivaroxaban): [active pathological bleeding or severe hypersensitivity reaction to XARELTO or ELIQUIS (e.g., anaphylactic reactions)]
Plan to become pregnant in the next three months.
Concomitant prescribed use of aspirin or thienopyridenes or other platelet inhibiting drugs
Plan for surgical hysterectomy or endometrial ablation
Known uterine cancer
Von Willebrand's disease, or hemophilia
Known coagulopathy from liver disease
Conditions likely to preclude adherence to study procedures: Active intravenous drug use, known alcoholism, homelessness, or uncontrolled psychiatric illness.
Intervention: Bimatoprost
Trial phase: Early Phase 1
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: This is a single-arm open label proof of concept pilot study evaluating use of Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping).

bimatoprost 0.03% ophthalmic solution: Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)
Eligibility criteria:
Inclusion Criteria:

18+,
mild to severe dermatochalasis, desire for enhanced eyelashes.

Exclusion Criteria:

Patients with current use of ophthalmic prostaglandin analogues,
history of blepharoplasty,
history of neuromodulators or fillers to the periocular region or frontalis in the last 6 months,
existing deep upper eyelid sulcus,
opposition to eyelash enhancement,
pregnancy.
Intervention: Zinc phosphide (Zn3P2)
Trial phase: Phase 3
SMILES: P=[Zn].P=[Zn].[Zn]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 640
Group description: Isopropyl alcohol (IPA) 70%

ZuraPrep: Apply topically.
Eligibility criteria:
Inclusion Criteria:

Subjects of any race.
Subjects in good health.
Minimum skin flora baseline requirements on abdomen and groin.
Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area.

Exclusion Criteria:

Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics.
Subjects with a history of skin sensitivity, skin allergies, or skin cancer.
Subjects who are pregnant, attempting pregnancy, or nursing.
Intervention: Chloraprep
Trial phase: Phase 3
SMILES: CC(C)O.NC(=NCCCCCCN=C(N)N=C(N)Nc1ccc(Cl)cc1)N=C(N)Nc1ccc(Cl)cc1.O=C(O)C(O)C(O)C(O)C(O)CO.O=C(O)CC(O)C(O)C(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 640
Group description: Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%

ChloraPrep: Apply topically.
Eligibility criteria:
Inclusion Criteria:

Subjects of any race.
Subjects in good health.
Minimum skin flora baseline requirements on abdomen and groin.
Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area.

Exclusion Criteria:

Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics.
Subjects with a history of skin sensitivity, skin allergies, or skin cancer.
Subjects who are pregnant, attempting pregnancy, or nursing.
Intervention: Zinc phosphide (Zn3P2)
Trial phase: Phase 3
SMILES: P=[Zn].P=[Zn].[Zn]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 440
Group description: Isopropyl alcohol (IPA) 70%

ZP: Apply topically.
Eligibility criteria:
Inclusion Criteria:

Subjects of any race
Subjects in good health
Minimum skin flora baseline requirements on abdomen and groin
Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area.

Exclusion Criteria:

Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics.
Subjects with a history of skin sensitivity, skin allergies, or skin cancer.
Subjects who are pregnant, attempting pregnancy or nursing.
Intervention: Chloraprep
Trial phase: Phase 3
SMILES: CC(C)O.NC(=NCCCCCCN=C(N)N=C(N)Nc1ccc(Cl)cc1)N=C(N)Nc1ccc(Cl)cc1.O=C(O)C(O)C(O)C(O)C(O)CO.O=C(O)CC(O)C(O)C(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 440
Group description: Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%

ChloraPrep: Apply topically.
Eligibility criteria:
Inclusion Criteria:

Subjects of any race
Subjects in good health
Minimum skin flora baseline requirements on abdomen and groin
Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area.

Exclusion Criteria:

Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics.
Subjects with a history of skin sensitivity, skin allergies, or skin cancer.
Subjects who are pregnant, attempting pregnancy or nursing.
Intervention: Benzocaine
Trial phase: Phase 4
ATC code: C05AD03 | D04AB04 | N01BA05 | R02AD01
SMILES: CCOC(=O)c1ccc(N)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: 40 mg of topical lidocaine and placebo is applied to the wrist overlying radial pulse (centered approximately 1 inch proximal to the radial styloid process) at least 60 minutes before arterial puncture. Immediately prior to sterile preparation of access site, transdermal preparation will be removed in the cath lab.

Topical Lidocaine: Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms
Eligibility criteria:
Inclusion Criteria:

Age: 18 years or older
Radial artery catheterization

Exclusion Criteria:

Hypersensitivity or contraindication to lidocaine
Hypersensitivity or contraindication to nitroglycerine
Recent use of phosphodiesterase 5 inhibitors (<24 hours after sildenafil or vardenafil; <48 hours after tadalafil)
Baseline weak radial pulse (0 or 1+)
Baseline hypotension SBP < 100 mmHg at the time of enrollment
Dizziness or light-headedness at the time of enrollment
Severe Aortic Stenosis or Hypertrophic obstructive cardiomyopathy
Previous unknown bypass grafts or known left internal mammary graft
Chest pain within 6 hours of IP administration
More than 2 episodes of chest pain within 24 hours prior to IP administration
Use of sublingual, transdermal, or intravenous nitroglycerine within 6 hours prior to IP administration
Likely need for use of nitroglycerine for non-study indication
Narcotic or sedative within 4 hours of enrollment
Women who are suspected or known to be pregnant or breastfeeding
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: Patients will receive 100 milliliters of normal saline with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses in 24 hours. Blinded medication will be prepared by research pharmacist.

normal saline: 100mL of normal saline every 4 hours to a maximum administration of 400mL
Eligibility criteria:
Inclusion Criteria:

Undergoing ambulatory laparoscopic cholecystectomy.
American Society of Anesthesiologists physical status 1, 2 or 3.-

Exclusion Criteria -

Cognitively impaired (by history) and unable or unwilling to consent
Chronic steroid or opioid user (as prescribed for a chronic systemic illness)
Parturient or nursing mother. Patients who have been informed by a physician that they have liver or kidney disease
Intervention: Etelcalcetide
Trial phase: Phase 1
ATC code: H05BX04
SMILES: CC(=O)N[C@H](CSSC[C@H](N)C(=O)O)C(=O)N[C@H](C)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](C)C(=O)N[C@H](CCCNC(=N)N)C(N)=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 11
Group description: Participants received a single, intravenous bolus administration of 0.035 mg/kg etelcalcetide at the end of hemodialysis on study day 1.
Eligibility criteria:
Inclusion Criteria:

Subject's parent has provided informed consent and subject has provided assent
Children Age 2 to less than 18 years
Diagnosed with chronic kidney disease
Diagnosed with secondary hyperparathyroidism receiving hemodialysis,
Weighing at least 7 kg
Laboratory results within specified range.

Exclusion Criteria:

Currently receiving treatment in another investigation device or drug study
Subject has received cinacalcet therapy within 30 days
History of prolongation QT interval
Subject is taking any medications that are on the QT prolongation medication list
Electrocardiograph (ECG) measurements within specified range.
Intervention: Linaclotide
Trial phase: Phase 4
ATC code: A06AX04
SMILES: CC1NC(=O)C2CCCN2C(=O)C(CC(N)=O)NC(=O)C2CSSCC(N)C(=O)NC3CSSCC(NC1=O)C(=O)NC(C(C)O)C(=O)NCC(=O)NC(C(=O)NC(Cc1ccc(O)cc1)C(=O)O)CSSCC(NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CCC(=O)O)NC3=O)C(=O)N2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: 290 μg linaclotide once daily for 4 weeks
Eligibility criteria:
Inclusion Criteria:

• Patient meets protocol criteria for diagnosis of IBS-C, abdominal pain, abdominal bloating and abdominal girth

Exclusion Criteria:

Patient has history of loose or watery stools
Patient has both clinically significant findings and unexplained clinically significant alarm symptoms
Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
Intervention: Daridorexant
Trial phase: Phase 2
ATC code: N05CJ03
SMILES: COc1ccc(-n2nccn2)c(C(=O)N2CCC[C@@]2(C)c2nc3c(C)c(Cl)ccc3[nH]2)c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks

ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Eligibility criteria:
Principal inclusion Criteria:

Signed informed consent prior to any study-mandated procedure.
Male or female aged 18-64 years (inclusive).
Women of childbearing potential must have negative pregnancy tests and use reliable methods of contraception up to 30 days after EOT.
Body mass index (BMI): 18.5 ≤ BMI (kg/m2) < 32.0.
Insomnia disorder according to DSM-5 criteria.
Insufficient sleep quantity as collected subjectively in the sleep diary and validated objectively by polysomnography.
Insomnia Severity Index score ≥ 15.

Principal exclusion Criteria:

Any current history of sleep disorder other than insomnia, or any lifetime history of related breathing disorder, periodic limb movement disorder, restless legs syndrome, circadian rhythm disorder, rapid eye movement (REM) behavior disorder, or narcolepsy.
Self-reported usual daytime napping ≥ 1 hour per day, and ≥ 3 days per week.
Caffeine consumption ≥ 600 mg per day.
Shift work within 2 weeks prior to the screening visit, or planned shift work during study.
Travel ≥ 3 time zones within 1 week prior to the screening visit, or planned travel > or= 3 time zones during study.
Hematology or biochemistry test results deviating from the normal range to a clinically relevant extent as per judgment of the Investigator.
AST and/or ALT > 2 × ULN and/or direct bilirubin > 1.5 × ULN (except known history of Gilbert's syndrome).
Severe renal impairment (known or defined as estimated creatinine clearance < 30 mL/min).
History or clinical evidence of any disease or medical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the study assessments.
Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol.