anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: ULIPRISTAL ACETATE
Trial phase: Phase 3
SMILES: CC(=O)O[C@]1(C(C)=O)CC[C@H]2[C@@H]3CCC4=CC(=O)CCC4=C3[C@@H](c3ccc(N(C)C)cc3)C[C@@]21C
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1104
Group description: CDB-2914: Single dose (30 mg)
Eligibility criteria:
Inclusion Criteria:

women 16 or older in UK(except Northern Ireland) sites, 17 years or more in Northern Ireland (UK) and 18 years or more in Ireland and US
present within 120 hours of unprotected intercourse
regular menstrual cycles
No current use of hormonal contraception
Willing to not use hormonal methods of contraception until study completion
At least one complete menstrual cycle (2 menses) post miscarriage, delivery or abortion
For women who present more than 72 hours after intercourse, decline the insertion of an Intra Uterine Device for emergency contraception
Able to provide informed consent
Willing to abstain from further acts of unprotected intercourse until study completion

Exclusion Criteria:

One or more acts of unprotected intercourse more than 120 hours
current or recent use of hormonal methods of contraception
currently pregnant or breastfeeding
tubal ligation or current use of IUD
Use of hormonal emergency contraception since last menstrual period
Current use of IUD
Tubal ligation
Partner with a vasectomy
Unsure about the date of the last menstrual period
Severe asthma insufficiently controlled by oral glucocorticoid
Hypersensitivity to the active substance levonorgestrel or any of the excipients of the drug products used in the study
Intervention: LEVONORGESTREL
Trial phase: Phase 3
ATC code: G03AA07 | G03AB03 | G03AC03 | G03AD01 | G03FA11 | G03FB09
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3([H])[C@@]1([H])CC[C@@]1(CC)[C@@]2([H])CC[C@@]1(O)C#C
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1117
Group description: Levonorgestrel: Single dose (1.5 mg)
Eligibility criteria:
Inclusion Criteria:

women 16 or older in UK(except Northern Ireland) sites, 17 years or more in Northern Ireland (UK) and 18 years or more in Ireland and US
present within 120 hours of unprotected intercourse
regular menstrual cycles
No current use of hormonal contraception
Willing to not use hormonal methods of contraception until study completion
At least one complete menstrual cycle (2 menses) post miscarriage, delivery or abortion
For women who present more than 72 hours after intercourse, decline the insertion of an Intra Uterine Device for emergency contraception
Able to provide informed consent
Willing to abstain from further acts of unprotected intercourse until study completion

Exclusion Criteria:

One or more acts of unprotected intercourse more than 120 hours
current or recent use of hormonal methods of contraception
currently pregnant or breastfeeding
tubal ligation or current use of IUD
Use of hormonal emergency contraception since last menstrual period
Current use of IUD
Tubal ligation
Partner with a vasectomy
Unsure about the date of the last menstrual period
Severe asthma insufficiently controlled by oral glucocorticoid
Hypersensitivity to the active substance levonorgestrel or any of the excipients of the drug products used in the study
Intervention: Nitric Oxide
Trial phase: Phase 3
ATC code: R07AX01
SMILES: [N]=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 395
Group description: INO administered by nasal continuous positive airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for between 7 and 21 days during the Treatment period, but no intervention during the 7-year Follow-up
Eligibility criteria:
Inclusion Criteria:

Inborn preterm infants 24+0 weeks-28+6 days weeks gestational age (defined by first trimester ultrasound or if not available based on the last menstrual period) who requires the use of surfactant within 24 hours of birth (either prophylactically, or for signs of developing respiratory distress), or who requires the use of continuous positive airway pressure (CPAP) (fraction of inspired oxygen concentration (FiO2) ≥ 0.30 on a mean airway pressure ≥ 4cm water (H2O)) within 24 hours of birth in order to maintain an oxygen saturation (SpO2) ≥ 85%.
Informed consent of the guardian.

Exclusion Criteria:

Outborn infants.
Infants ≥ 29 weeks gestational age.
Infants requiring FiO2 >0.5 to maintain SpO2 >85%, on a sufficient mean airway pressure (e.g., > 8 cm H2O on controlled mechanical ventilation (CMV)) in order to achieve adequate chest inflation (8-9 ribs on Chest X-ray) two hours after the proper administration of exogenous surfactant.
Any suspected congenital heart disease other than patent ductus arteriosus or atrial septal defect.
Any infant with severe bleeding or coagulation abnormalities at high-risk of diathesis, e.g., platelet <50,000 per millimeter cube (mm³), fibrinogen <0.5 gram per liter (g/L), other clotting factors <10%.
Any infant in whom a decision has been made not to provide full treatment, e.g., chromosomal abnormalities, severe multiple abnormalities, severe birth asphyxia, etc.
Use of another investigational drug or device before or during the active study period.
Intervention: Linolenic Acid
Trial phase: Phase 4
SMILES: CCC=CCC=CCC=CCCCCCCCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 126
Group description: 4 grams fish oil daily for 24 weeks

Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

>=21 years of age
a history of atrial fibrillation
a history of at least two occurrences of atrial fibrillation or atrial flutter, at least one of which is atrial fibrillation
an electrocardiogram that was recorded within 12 months of randomization showing atrial fibrillation or atrial flutter
sinus rhythm at the time the first dose of randomized medication is taken
stable antiarrhythmic medications
if the patient has had an ablation for atrial fibrillation or flutter or a MAZE procedure, the qualifying episode of atrial fibrillation must have occurred at least 3 months post-procedure
normal serum potassium level within the last 28 days
provided informed consent

Exclusion Criteria:

permanent atrial fibrillation or flutter
New York Heart Association class III or IV heart failure or Canadian Cardiovascular Society class III or IV angina pectoris
cardiac or thoracic surgery within the previous 3 months
acute pericarditis within the previous 3 months
other reversible causes of atrial fibrillation such as thyrotoxicosis
acute myocardial infarction or unstable angina within the previous 3 months
history of neurologic event (TIA or stroke)within the past 3 months
history of acute congestive heart failure precipitated by atrial fibrillation, and the patient is not receiving rate-control therapy
Wolff-Parkinson-White syndrome
a medical condition that is likely to be fatal in less than one year
active, uncontrolled co-morbid inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease, SLE)
receiving cytotoxic chemotherapy or radiotherapy for cancer
taking a fish oil supplement
allergic to fish
bleeding event not related to trauma or surgery requiring hospitalization or transfusion in previous year
systolic blood pressure < 90 mm Hg or heart rate <50 beats/minute
history of ventricular fibrillation or sustained ventricular tachycardia, or presence of an implanted defibrillator placed for the occurrence of such an event or the presence of an Implantable Cardioverter-Defibrillator (ICD) that has discharged appropriately for a ventricular arrhythmia
pregnant or breast feeding
enrollment in another research study involving an intervention
on dialysis or recipient of a renal transplant
use of potentially cardiotoxic illegal drugs (cocaine, methamphetamine, opioids) in the last 12 months
Treated for alcoholism and currently drinking alcohol to excess or alcoholic cardiomyopathy as the primary clinical diagnosis and currently drinking alcohol to excess
presence of an iron-storage disease, such as hemochromatosis, transfusional hemosiderosis, or those subjects in whom a daily dose of up to 20 mg elemental iron (in and of itself or in addition of current iron supplementation) would post a risk for toxicity from iron overload
subjects receiving or anticipated to receive intravenous iron therapy
Intervention: Lacosamide
Trial phase: Phase 2
ATC code: N03AX18
SMILES: COC[C@@H](NC(C)=O)C(=O)NCc1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 370
Group description: 50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
Eligibility criteria:
Inclusion Criteria:

Completion of parent clinical trial for treatment of partial seizures.

Exclusion Criteria:

Receiving any study drug or experimental device other than lacosamide.
Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event.
Intervention: Buprenorphine Hydrochloride
Trial phase: Phase 4
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of chronic refractory pain
Clinical diagnosis of opiate dependency

Exclusion Criteria:

unable to pay for medication
enrolled in a methadone maintenance program
homelessness
major mental illness
pregnant women
prisoners
terminal cancer pain
Intervention: Buprenorphine Hydrochloride
Trial phase: Phase 4
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of chronic refractory pain
Clinical diagnosis of opiate dependency

Exclusion Criteria:

unable to pay for medication
enrolled in a methadone maintenance program
homelessness
major mental illness
pregnant women
prisoners
terminal cancer pain
Intervention: Sugammadex
Trial phase: Phase 2
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
Eligibility criteria:
Inclusion Criteria:

Participants of American Society of Anesthesiologists (ASA) class 1 - 3;
Participants at least 20 years but under 65 years of age;
Caucasian participants ;
Participants scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia, in need of administration of a neuromuscular blocking agent (NMBA), with an anticipated duration of about 1.5- 3 hours;
Participants who had given written informed consent. This was obtained before the investigator or the sub-investigator performed any procedures or assessments for the screening, and after the participant was informed about the nature and purpose of the study, the study procedures, and the risks and restrictions of the study.

Exclusion criteria:

Participants in whom a difficult intubation because of anatomical malformations was expected;
Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade (NMB) and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic dysfunction.
Participants known or suspected to have a (family) history of malignant hyperthermia;
Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
Participants receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
Female participants who were pregnant;
Female participants of childbearing potential not using birth control or using only oral contraception as birth control;
Participants who were breast-feeding;
Participants who had already participated in CT 19.4.209B, or in another trial with sugammadex;
Participants who had participated in another clinical trial, not preapproved by Organon, within 6 months of entering into CT 19.4.209B.
Intervention: Sugammadex
Trial phase: Phase 2
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
Eligibility criteria:
Inclusion Criteria:

Participants of American Society of Anesthesiologists (ASA) class 1 - 3;
Participants at least 20 years but under 65 years of age;
Caucasian participants ;
Participants scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia, in need of administration of a neuromuscular blocking agent (NMBA), with an anticipated duration of about 1.5- 3 hours;
Participants who had given written informed consent. This was obtained before the investigator or the sub-investigator performed any procedures or assessments for the screening, and after the participant was informed about the nature and purpose of the study, the study procedures, and the risks and restrictions of the study.

Exclusion criteria:

Participants in whom a difficult intubation because of anatomical malformations was expected;
Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade (NMB) and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic dysfunction.
Participants known or suspected to have a (family) history of malignant hyperthermia;
Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
Participants receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
Female participants who were pregnant;
Female participants of childbearing potential not using birth control or using only oral contraception as birth control;
Participants who were breast-feeding;
Participants who had already participated in CT 19.4.209B, or in another trial with sugammadex;
Participants who had participated in another clinical trial, not preapproved by Organon, within 6 months of entering into CT 19.4.209B.
Intervention: Sugammadex
Trial phase: Phase 2
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Sugammadex 4.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.9 mg/kg rocuronium (single-bolus IV dose) for intubation, followed by maintenance doses of rocuronium 0.1-0.2 mg/kg if necessary
Eligibility criteria:
Inclusion Criteria:

Participants of American Society of Anesthesiologists (ASA) class 1 - 3;
Participants at least 20 years but under 65 years of age;
Caucasian participants ;
Participants scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia, in need of administration of a neuromuscular blocking agent (NMBA), with an anticipated duration of about 1.5- 3 hours;
Participants who had given written informed consent. This was obtained before the investigator or the sub-investigator performed any procedures or assessments for the screening, and after the participant was informed about the nature and purpose of the study, the study procedures, and the risks and restrictions of the study.

Exclusion criteria:

Participants in whom a difficult intubation because of anatomical malformations was expected;
Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade (NMB) and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic dysfunction.
Participants known or suspected to have a (family) history of malignant hyperthermia;
Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
Participants receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
Female participants who were pregnant;
Female participants of childbearing potential not using birth control or using only oral contraception as birth control;
Participants who were breast-feeding;
Participants who had already participated in CT 19.4.209B, or in another trial with sugammadex;
Participants who had participated in another clinical trial, not preapproved by Organon, within 6 months of entering into CT 19.4.209B.
Intervention: Sugammadex
Trial phase: Phase 2
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Sugammadex 1.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
Eligibility criteria:
Inclusion Criteria:

Participants of American Society of Anesthesiologists (ASA) class 1 - 3;
Participants at least 20 years but under 65 years of age;
Caucasian participants ;
Participants scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia, in need of administration of a neuromuscular blocking agent (NMBA), with an anticipated duration of about 1.5- 3 hours;
Participants who had given written informed consent. This was obtained before the investigator or the sub-investigator performed any procedures or assessments for the screening, and after the participant was informed about the nature and purpose of the study, the study procedures, and the risks and restrictions of the study.

Exclusion criteria:

Participants in whom a difficult intubation because of anatomical malformations was expected;
Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade (NMB) and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic dysfunction.
Participants known or suspected to have a (family) history of malignant hyperthermia;
Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
Participants receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
Female participants who were pregnant;
Female participants of childbearing potential not using birth control or using only oral contraception as birth control;
Participants who were breast-feeding;
Participants who had already participated in CT 19.4.209B, or in another trial with sugammadex;
Participants who had participated in another clinical trial, not preapproved by Organon, within 6 months of entering into CT 19.4.209B.
Intervention: Sugammadex
Trial phase: Phase 2
ATC code: V03AB35
SMILES: O=C(O)CCSCC1OC2OC3C(CSCCC(=O)O)OC(OC4C(CSCCC(=O)O)OC(OC5C(CSCCC(=O)O)OC(OC6C(CSCCC(=O)O)OC(OC7C(CSCCC(=O)O)OC(OC8C(CSCCC(=O)O)OC(OC9C(CSCCC(=O)O)OC(OC1C(O)C2O)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C(O)C3O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Sugammadex 2.0 mg/kg administered as a single-bolus IV dose at 1-2 PTC after 0.1 mg/kg vecuronium (single-bolus IV dose) for intubation, followed by maintenance doses of vecuronium 0.02-0.3 mg/kg if necessary
Eligibility criteria:
Inclusion Criteria:

Participants of American Society of Anesthesiologists (ASA) class 1 - 3;
Participants at least 20 years but under 65 years of age;
Caucasian participants ;
Participants scheduled for elective surgery requiring muscle relaxation in supine position and under sevoflurane anesthesia, in need of administration of a neuromuscular blocking agent (NMBA), with an anticipated duration of about 1.5- 3 hours;
Participants who had given written informed consent. This was obtained before the investigator or the sub-investigator performed any procedures or assessments for the screening, and after the participant was informed about the nature and purpose of the study, the study procedures, and the risks and restrictions of the study.

Exclusion criteria:

Participants in whom a difficult intubation because of anatomical malformations was expected;
Participants known or suspected to have neuromuscular disorders impairing neuromuscular blockade (NMB) and/or significant renal dysfunction (for example a creatinine level > 1.6 mg/dl) and/or severe hepatic dysfunction.
Participants known or suspected to have a (family) history of malignant hyperthermia;
Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia;
Participants receiving medication expected to interfere with the rocuronium or vecuronium given in this trial, based on the dose and time of administration;
Female participants who were pregnant;
Female participants of childbearing potential not using birth control or using only oral contraception as birth control;
Participants who were breast-feeding;
Participants who had already participated in CT 19.4.209B, or in another trial with sugammadex;
Participants who had participated in another clinical trial, not preapproved by Organon, within 6 months of entering into CT 19.4.209B.