anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Baclofen
Trial phase: Phase 3
ATC code: M03BX01
SMILES: NCC(CC(=O)O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 179
Group description: 40 mg/day Arbaclofen Extended-Release Tablets
Eligibility criteria:
Inclusion Criteria Includes:

Subjects 18 to 65 years of age, inclusive.
An established diagnosis of MS that manifests a documented history of spasticity.
If receiving disease-modifying medications (eg, interferons approved for MS, glatiramer acetate, natalizumab, fingolimod, or mitoxantrone), there must be no change in dose for at least 3 months prior to Visit 1 (Screening), and the subject must be willing to maintain this treatment dose for the duration of the study. If receiving AMPYRA® (dalfampridine, fampridine, 4-amino puridine), subject must be at a stable dose for at least 3 months prior to Visit 1.
Stable regimen for at least 3 months prior to Visit 2 for all medications and non-pharmacological therapies that are intended to alleviate spasticity.
Absence of infections, peripheral vascular disease, painful contractures, advanced arthritis, or other conditions that hinder evaluation of joint movement.
Use of a medically highly effective form of birth control (see Section 7.8) during the study and for 3 months thereafter for women of child-bearing potential (including female subjects and female partners of non-sterile male subjects).
Willing to sign the informed consent form (ICF).

Exclusion Criteria Includes:

Any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject's level of spasticity.
Concomitant use of medications that would potentially interfere with the actions of the study medication or outcome variables.
Pregnancy, lactation, or planned pregnancy during the course of the study and for 3 months after the final study visit.
Subject has clinically significant abnormal laboratory values, in the opinion of the investigator, at Visit 1 or Visit 2.
Current malignancy or history of malignancy that has not been in remission for more than 5 years, except effectively treated basal cell skin carcinoma.
Any other significant disease, disorder, or significant laboratory finding which, in the opinion of the investigator, puts the subject at risk because of participation, influences the result of the study, or affects the subject's ability to participate.
Intervention: Tasimelteon
Trial phase: Phase 2
ATC code: N05CH03
SMILES: CCC(=O)NC[C@@H]1C[C@H]1c1cccc2c1CCO2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: tasimelteon, administered as oral capsule(s)

Tasimelteon: capsule
Eligibility criteria:
Inclusion Criteria:

Ability and acceptance to provide written consent
Men or women between 18-75 years
Body Mass Index of ≥ 18 and ≤ 30 kg/m2

Exclusion Criteria:

History (within the 12 months prior to screening) of psychiatric disorders
Major surgery, trauma, illness or immobile for 3 or more days within the past month
Pregnancy or recent pregnancy (within 6 weeks)
A positive test for drugs of abuse at the screening visit
Any other sound medical reason as determined by the clinical investigator
Intervention: Elismetrep
Trial phase: Phase 2
SMILES: O=C(O)c1ccc(S(=O)(=O)N(Cc2ccc(OC(F)(F)F)cc2)c2ncc3ccccc3c2C2CC2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 95
Group description: MT-8554 1mg QD, oral, 12 weeks
Eligibility criteria:
Inclusion Criteria:

Additional screening criteria check may apply for qualification:

Provide written informed consent to participate in this study
Spontaneous amenorrhea for ≥12 months; or spontaneous amenorrhea for at least 6 months and with follicle stimulating hormone (FSH) levels >40 mIU/mL; or documented bilateral salpingo oophorectomy ≥6 weeks, with or without hysterectomy
7 or more moderate to severe VMS per day, or 50 or more moderate to severe VMS per week
Have a consistent bedtime on at least 5 nights per week
Mean VMS frequency during the Placebo Run in period does not drop by more than 50% from the mean level reported for 2 weeks during the Screening period
VMS diary compliance >50%
In the Investigator's opinion, subject is able to understand the nature of the study and any risk involved in participation, and is willing to cooperate and comply with the protocol restrictions and requirements

Exclusion Criteria:

Additional screening criteria check may apply for qualification:

History of any cancer within 5 years except for basal cell carcinoma
History of undiagnosed abnormal vaginal bleeding
History of Hepatitis B, Hepatitis C or HIV
History of psychiatric illness, excessive alcohol intake or use of recreational drugs who are unsuitable for study enrollment and compliance
Presence or history of severe adverse reaction or allergy to any drug
Peripheral vascular disease or disorders with associated vasculopathies
Clinically significant conditions which could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator
Endometrial thickness of >=5 mm as measured by transvaginal ultrasound
Abnormal result from baseline endometrial biopsy (i.e., endometrial hyperplasia or endometrial cancer)
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin ≥2.0 × upper limit of normal (ULN) above the reference range
Subjects of childbearing potential
Intervention: Elismetrep
Trial phase: Phase 2
SMILES: O=C(O)c1ccc(S(=O)(=O)N(Cc2ccc(OC(F)(F)F)cc2)c2ncc3ccccc3c2C2CC2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 90
Group description: MT-8554 5mg QD, oral, 12 weeks
Eligibility criteria:
Inclusion Criteria:

Additional screening criteria check may apply for qualification:

Provide written informed consent to participate in this study
Spontaneous amenorrhea for ≥12 months; or spontaneous amenorrhea for at least 6 months and with follicle stimulating hormone (FSH) levels >40 mIU/mL; or documented bilateral salpingo oophorectomy ≥6 weeks, with or without hysterectomy
7 or more moderate to severe VMS per day, or 50 or more moderate to severe VMS per week
Have a consistent bedtime on at least 5 nights per week
Mean VMS frequency during the Placebo Run in period does not drop by more than 50% from the mean level reported for 2 weeks during the Screening period
VMS diary compliance >50%
In the Investigator's opinion, subject is able to understand the nature of the study and any risk involved in participation, and is willing to cooperate and comply with the protocol restrictions and requirements

Exclusion Criteria:

Additional screening criteria check may apply for qualification:

History of any cancer within 5 years except for basal cell carcinoma
History of undiagnosed abnormal vaginal bleeding
History of Hepatitis B, Hepatitis C or HIV
History of psychiatric illness, excessive alcohol intake or use of recreational drugs who are unsuitable for study enrollment and compliance
Presence or history of severe adverse reaction or allergy to any drug
Peripheral vascular disease or disorders with associated vasculopathies
Clinically significant conditions which could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator
Endometrial thickness of >=5 mm as measured by transvaginal ultrasound
Abnormal result from baseline endometrial biopsy (i.e., endometrial hyperplasia or endometrial cancer)
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin ≥2.0 × upper limit of normal (ULN) above the reference range
Subjects of childbearing potential
Intervention: Elismetrep
Trial phase: Phase 2
SMILES: O=C(O)c1ccc(S(=O)(=O)N(Cc2ccc(OC(F)(F)F)cc2)c2ncc3ccccc3c2C2CC2)cc1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 93
Group description: MT-8554 10mg QD, oral, 12 weeks
Eligibility criteria:
Inclusion Criteria:

Additional screening criteria check may apply for qualification:

Provide written informed consent to participate in this study
Spontaneous amenorrhea for ≥12 months; or spontaneous amenorrhea for at least 6 months and with follicle stimulating hormone (FSH) levels >40 mIU/mL; or documented bilateral salpingo oophorectomy ≥6 weeks, with or without hysterectomy
7 or more moderate to severe VMS per day, or 50 or more moderate to severe VMS per week
Have a consistent bedtime on at least 5 nights per week
Mean VMS frequency during the Placebo Run in period does not drop by more than 50% from the mean level reported for 2 weeks during the Screening period
VMS diary compliance >50%
In the Investigator's opinion, subject is able to understand the nature of the study and any risk involved in participation, and is willing to cooperate and comply with the protocol restrictions and requirements

Exclusion Criteria:

Additional screening criteria check may apply for qualification:

History of any cancer within 5 years except for basal cell carcinoma
History of undiagnosed abnormal vaginal bleeding
History of Hepatitis B, Hepatitis C or HIV
History of psychiatric illness, excessive alcohol intake or use of recreational drugs who are unsuitable for study enrollment and compliance
Presence or history of severe adverse reaction or allergy to any drug
Peripheral vascular disease or disorders with associated vasculopathies
Clinically significant conditions which could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator
Endometrial thickness of >=5 mm as measured by transvaginal ultrasound
Abnormal result from baseline endometrial biopsy (i.e., endometrial hyperplasia or endometrial cancer)
Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin ≥2.0 × upper limit of normal (ULN) above the reference range
Subjects of childbearing potential
Intervention: Buprenorphine Hydrochloride
Trial phase: Phase 2
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5.Cl
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 26
Group description: Participants receiving buprenorphine-naloxone treatment for opioid use disorder during pregnancy

fetal monitoring: Maternal fetal monitoring

Buprenorphine Naloxone: Treatment for opioid use disorder
Eligibility criteria:
Inclusion Criteria:

Current opioid use disorder (OUD) as defined by DSM V criteria
singleton pregnancies, generally uncomplicated by conditions that jeopardize pregnancy outcome
Gestation less than 24 weeks

Exclusion Criteria:

Complications of pregnancy, including gestational diabetes, polyhydramnios, hypertension, placenta previa or significant risk of preterm delivery;
Evidence of fetal malformation detected by prenatal ultrasound;
Significant general maternal health problems that can affect fetal functioning, including Type I or gestational diabetes, alterations in thyroid functioning, HIV infection or hypertension;
Significant maternal psychopathology that would preclude informed consent;
Alcohol use disorder per DSM V criteria (see ascertainment methods below)
Women stable on methadone maintenance (defined as more than 3 consecutive days of dosing)
Women coming to treatment reporting "street" methadone use (for more than 3 consecutive days
Women not planning to receive obstetric care at the Center for Addiction and Pregnancy; - Women not planning to deliver their infants at Johns Hopkins Bayview Medical center
Women planning for adoption of their infant.
Intervention: Cyclosporine
Trial phase: Phase 2 | Phase 3
ATC code: L04AD01 | S01XA18
SMILES: CC=CCC(C)C(O)C1C(=O)NC(CC)C(=O)N(C)CC(=O)N(C)C(CC(C)C)C(=O)NC(C(C)C)C(=O)N(C)C(CC(C)C)C(=O)NC(C)C(=O)NC(C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(C(C)C)C(=O)N1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 162
Group description: Cylclosporine A solution in vehicle

CyclASol topical ocular, eye drops: Cyclosporine A solution in vehicle
Eligibility criteria:
Inclusion Criteria:

Signed ICF (Informed Consent Form) and HIPAA (Health Insurance Portability and Accountability Act)
Patient-reported history of DED in both eyes
Current use of OTC (over-the-counter) and/or artificial tears for dry eye symptoms
Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

Women who are pregnant, nursing or planning a pregnancy
Unwillingness to submit a urine pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
Clinically significant slit-lamp findings or abnormal lid anatomy at screening
Ocular/periocular malignancy
History of herpetic keratitis
Active ocular allergies or ocular allergies that may become active during the study period
Ongoing ocular or systemic infection at screening or baseline
Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study
History of no response to previous topical Cyclosporine A and/or use of topical Cyclosporine A or Liftigrast within 2 months prior to screening
Intraocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period
Presence of uncontrolled systemic diseases
Presence of known allergy and/or sensitivity to the study drug or its components
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 42
Group description: ERAS Plus laparoscopic TAP block and transmuscular quadratus lumbarum with liposomal bupivicaine
Eligibility criteria:
Inclusion Criteria:

Patients undergoing laparoscopic donor nephrectomy

Exclusion Criteria:

Pregnancy
Systemic or local infection at the potential block site.
Allergy or hypersensitivity to the local anesthetic,
Possible variations in surgical approach to donor nephrectomy other than what is defined in this protocol.
Scarring or anatomic abnormality over the proposed injection site
Intervention: Lovenox
Trial phase: Phase 4
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 122
Group description: Group one will be instructed to administer their last dose of enoxaparin at 07:00 in the morning on the day prior to their scheduled surgery date. This will mean that patients who have their surgery scheduled for 07:00 the following day will be 24-hours removed from their last dose. Patients presenting for surgery later in the day would be slightly farther removed from their last dose, however this is currently considered normal clinical practice.

Enoxaparin: This is the historical control arm. 24 hours removed from their last dose (time period from the last dose of treatment dose Enoxaparin to the blood sampling for anti-Xa testing)
Eligibility criteria:
Inclusion Criteria:

Eligible patients need:

to be on treatment dose (1mg/kg twice daily or 1.5mg/kg daily) enoxaparin at the time of presentation for elective surgery
and must be able to accurately report the timing of their last dose and the administered dosage.
Patients must also be between the ages of 18-100 years of age
and must be able to give written consent to participate.

Exclusion Criteria:

Patients with severe renal insufficiency (creatinine clearance <30ml/min) will be excluded from the study, as the elimination of enoxaparin is known to be affected in this patient population.
Pregnant patients will also be excluded, as the elimination and metabolism of enoxaparin is known to be altered in this patient population, and dose adjustments are recommended if treatment dose enoxaparin is used during pregnancy.
Patients who are receiving enoxaparin as a bridge from another anti-Xa inhibiting medication will be excluded as this could unpredictably affect the results of anti-Xa testing. These medications include: Apixaban, Edoxaban, Fondaparinux, and Xarelto.
Intervention: Lovenox
Trial phase: Phase 4
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 122
Group description: Group 2 will be instructed to administer their last dose of enoxaparin at 19:00 in the evening two days prior to their scheduled surgery date. Patients presenting for surgery at 07:00 two days later will be 36-hours removed from their last dose. Patients presenting for surgery later in the day would be slightly farther removed from their last dose, but again this mimics normal clinical practice in which the timing of the last dose of self-administered enoxaparin is not routinely adjusted based on the scheduled surgical start time.

Enoxaparin: The intervention is the implementation of a 36-hour time period from the last dose of treatment dose Enoxaparin to the blood sampling for anti-Xa testing.
Eligibility criteria:
Inclusion Criteria:

Eligible patients need:

to be on treatment dose (1mg/kg twice daily or 1.5mg/kg daily) enoxaparin at the time of presentation for elective surgery
and must be able to accurately report the timing of their last dose and the administered dosage.
Patients must also be between the ages of 18-100 years of age
and must be able to give written consent to participate.

Exclusion Criteria:

Patients with severe renal insufficiency (creatinine clearance <30ml/min) will be excluded from the study, as the elimination of enoxaparin is known to be affected in this patient population.
Pregnant patients will also be excluded, as the elimination and metabolism of enoxaparin is known to be altered in this patient population, and dose adjustments are recommended if treatment dose enoxaparin is used during pregnancy.
Patients who are receiving enoxaparin as a bridge from another anti-Xa inhibiting medication will be excluded as this could unpredictably affect the results of anti-Xa testing. These medications include: Apixaban, Edoxaban, Fondaparinux, and Xarelto.
Intervention: Ondansetron
Trial phase: Phase 4
ATC code: A04AA01
SMILES: Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 141
Group description: Ondansetron 4 MG Pre-emergence
Eligibility criteria:
Inclusion Criteria:

ASA I, II, III presenting for ambulatory surgery to be performed under general anesthesia

Exclusion Criteria:

Patients with allergies or contraindications to study medications
Intervention: Ondansetron
Trial phase: Phase 4
ATC code: A04AA01
SMILES: Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 141
Group description: Ondansetron 8mg Pre-emergence
Eligibility criteria:
Inclusion Criteria:

ASA I, II, III presenting for ambulatory surgery to be performed under general anesthesia

Exclusion Criteria:

Patients with allergies or contraindications to study medications
Intervention: Ondansetron
Trial phase: Phase 4
ATC code: A04AA01
SMILES: Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 141
Group description: 4mg Ondansetron Pre-Incision and 4mg Ondansetron Pre-emergence
Eligibility criteria:
Inclusion Criteria:

ASA I, II, III presenting for ambulatory surgery to be performed under general anesthesia

Exclusion Criteria:

Patients with allergies or contraindications to study medications
Intervention: Fenfluramine
Trial phase: Phase 3
ATC code: A08AA02 | A08AA04 | N03AX26
SMILES: CCNC(C)Cc1cccc(C(F)(F)F)c1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Participants received ZX008 (fenfluramine hydrochloride) as an oral solution in a concentration of 2.5 milligrams per milliliter (mg/mL). Participants were titrated to an effective dose beginning with 0.2 milligrams per kilogram per day (mg/kg/day) to maximum dose of 30 mg/day. Study medication was administered twice a day (BID) in equally divided doses with food for 12 consecutive weeks, as per main study protocol, ZX008-1503 [NCT02823145]. For this substudy, ZX008-1503-SS01, all participants were required to wear the noninvasive Empatica Embrace watch system (EMBRACE) wrist-worn monitoring device.
Eligibility criteria:
Inclusion Criteria:

Meeting all of the main study ZX008-1503 [NCT02823145] inclusion criteria
Subject is willing to wear the Embrace watch on the wrist (alternatively ankle, if needed for younger children). Subjects are asked to wear the watch for as many hours of the day as possible and for the entire night, if possible, for the duration of the sub-study.
Subject's parent/caregiver is willing to use the Alert App.
Subject/subject's caregiver is willing to ensure that the Embrace watch remains within close proximity of the paired iPod Touch running the Empatica Alert app.

Exclusion Criteria:

Subject has a known hypersensitivity to any of the Embrace device materials.
Subject has a clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to Visit 1, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the subject.
Intervention: Hydromorphone
Trial phase: Phase 4
ATC code: N02AA03 | N02AA53 | N02AG04
SMILES: [H][C@@]12CCC(=O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 77
Group description: Intravenous hydromorphone 1mg. A second dose can be administered at 30 minutes.

Hydromorphone: Hydromorphone intravenous infusion
Eligibility criteria:
Inclusion Criteria:Eligible patients are those who present to an ED for treatment of acute abdominal pain. Acute will be defined as pain for no more than seven days. At the time of enrollment, the ED treatment plan must include use of an intravenous opioid.

Exclusion Criteria: Patients will be excluded from participation if they have cardiac conduction system impairment (QTc duration > 0.5s, QRS duration > 0.12s, or PR interval duration > 0.2s), known renal (CKD >2) or liver disease (Childs-Pugh B or greater), are hemodynamically unstable, as determined by the attending physician, are pregnant or breastfeeding, or have a known allergy to either medication. Patients will also be excluded if they have used prescription or illicit opioids within the previous week, or if they have a chronic pain disorder, defined as use of any analgesic medication on more days than not during the month preceding the acute episode of pain. Patients weighing < 60kg or > 120kg will be excluded.

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