anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ambrisentan
Trial phase: Phase 2
ATC code: C02KX02 | C02KX52
SMILES: COC(c1ccccc1)(c1ccccc1)[C@H](Oc1nc(C)cc(C)n1)C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 13
Group description: Oral ambrisentan 2.5 - 5 mg, single dose, once daily

Ambrisentan: Once daily oral dosing
Eligibility criteria:
Inclusion Criteria:

Age ≥ 24 months; ≤120 months.
History of congenital heart disease with severe hypoplasia of a right or left ventricle.
Undergoing Fontan surgery as part of standard clinical care.
Availability and willingness of the parent/legally authorized representative to provide written informed consent and, as appropriate, assent from the child.

Exclusion Criteria:

History of serious adverse event related to ambrisentan administration.
History of ambrisentan exposure within 48 hours of the study.
Presence of pulmonary venous obstruction.
Treatment with cyclosporin.

Any of the following - as determined by the attending physician

Significant hemodynamic instability
Sepsis.
Need for ECMO support.
Renal failure defined as serum creatinine > 2 times higher than the upper limit of normal.
Liver dysfunction defined as alanine aminotransferase or aspartate aminotransferase > 3 times higher than the upper limit of normal.
Thrombocytopenia defined as a platelet count < 50 000 cells/µL.
Leukopenia defined as white blood cells < 2500 cells/µL.
Anemia defined as hemoglobin < 8mg/dL.
Atrial hypertension (mean LA pressure > 12mm Hg).
Intervention: Citalopram
Trial phase: Phase 2
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Citalopram (20mg dose)

Citalopram: 20 mg or 40 mg daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Male and female subjects age 18 to 50 who meet current DSM-IV criteria for cocaine dependence who are seeking treatment.

Exclusion Criteria:

Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, nicotine, or alcohol
Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
Significant current suicidal or homicidal ideation
Medical conditions contraindicating citalopram pharmacotherapy (liver disease, seizure disorder, bleeding disorder, or prolonged QT interval on EKG)
Taking CNS active concomitant medications
Taking medications known to have significant drug interactions with the study medication
Having conditions of probation or parole requiring reports of drug use to officers of the court
Impending incarceration
Pregnant or breast feeding for female patients
Inability to read, write, or speak English
Having plans to leave the immediate geographical area within 3 months
Unwillingness or not competent to sign a written informed consent form
Individuals who have pacemakers, metal or electromechanical implants or metallic foreign bodies
Patients who are known to be HIV positive will not be included due to possible CNS effects of HIV.
Alcohol withdrawal symptoms or history of significant previous alcohol withdrawal symptoms.
Intervention: Citalopram
Trial phase: Phase 2
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Citalopram 40mg dose

Citalopram: 20 mg or 40 mg daily for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Male and female subjects age 18 to 50 who meet current DSM-IV criteria for cocaine dependence who are seeking treatment.

Exclusion Criteria:

Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, nicotine, or alcohol
Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
Significant current suicidal or homicidal ideation
Medical conditions contraindicating citalopram pharmacotherapy (liver disease, seizure disorder, bleeding disorder, or prolonged QT interval on EKG)
Taking CNS active concomitant medications
Taking medications known to have significant drug interactions with the study medication
Having conditions of probation or parole requiring reports of drug use to officers of the court
Impending incarceration
Pregnant or breast feeding for female patients
Inability to read, write, or speak English
Having plans to leave the immediate geographical area within 3 months
Unwillingness or not competent to sign a written informed consent form
Individuals who have pacemakers, metal or electromechanical implants or metallic foreign bodies
Patients who are known to be HIV positive will not be included due to possible CNS effects of HIV.
Alcohol withdrawal symptoms or history of significant previous alcohol withdrawal symptoms.
Intervention: Ledipasvir
Trial phase: Phase 2
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 4 HCV infection
Eligibility criteria:
Inclusion Criteria:

HCV RNA ≥ 10^4 IU/mL at screening
Chronic genotype 4 or 5 HCV Infection
Individuals may be treatment naive or treatment experienced
Presence or absence of cirrhosis, a liver biopsy may be required
Healthy according to medical history and physical examination with the exception of HCV diagnosis
Agree to use two forms of highly effective contraception for the duration of the study

Exclusion Criteria:

History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the individual's participation for the full duration of the study or not be in the best interest of the individual in the opinion of the investigator
Prior exposure to approved or experimental HCV specific direct acting antiviral(s) (DAA) other than NS3/4A protease inhibitors
History of any other clinically significant chronic liver disease
Evidence of or history of decompensated liver disease
HIV or chronic hepatitis B (HBV) infection
Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
Chronic use of immunosuppressive agents or immunomodulatory agents
Intervention: Ledipasvir
Trial phase: Phase 2
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection
Eligibility criteria:
Inclusion Criteria:

HCV RNA ≥ 10^4 IU/mL at screening
Chronic genotype 4 or 5 HCV Infection
Individuals may be treatment naive or treatment experienced
Presence or absence of cirrhosis, a liver biopsy may be required
Healthy according to medical history and physical examination with the exception of HCV diagnosis
Agree to use two forms of highly effective contraception for the duration of the study

Exclusion Criteria:

History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the individual's participation for the full duration of the study or not be in the best interest of the individual in the opinion of the investigator
Prior exposure to approved or experimental HCV specific direct acting antiviral(s) (DAA) other than NS3/4A protease inhibitors
History of any other clinically significant chronic liver disease
Evidence of or history of decompensated liver disease
HIV or chronic hepatitis B (HBV) infection
Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
Chronic use of immunosuppressive agents or immunomodulatory agents
Intervention: Ticagrelor
Trial phase: Not Applicable
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
Eligibility criteria:
Inclusion criteria:

Patients with angiographically documented coronary artery disease.
Age between 18 to 80 years
On treatment per standard of care with ticagrelor 90mg/b.i.d. and aspirin <100mg/day for at least 14 days.

Exclusion criteria

History of intracranial bleeding
Known severe hepatic dysfunction
Known hypersensitivy
Active bleeding or propensity to bleed
Platelet count <80x106/mL
Hemodynamic instability
Serum creatinine <30 mL/min
Use of oral anticoagulants (Vitamin K antagonist, dabigatran, rivaroxaban, apixaban)
Recent (<14 days) antiplatelet treatment with a glycoprotein IIb/IIIa inhibitor
Blood dyscrasia
Patients with sick sinus syndrome (SSS) or II or III degree AV block without pacemaker
Drugs interfering CYP3A4 metabolism (to avoid interaction with Ticagrelor): Ketoconazole, itraconazole, voriconazole, clarithromicin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromizycin
Hemoglobin < 10g/dL
Pregnant females [women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study].
Intervention: Tenapanor
Trial phase: Phase 2
ATC code: A06AX08
SMILES: CN1Cc2c(Cl)cc(Cl)cc2[C@H](c2cccc(S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)c3cccc([C@@H]4CN(C)Cc5c(Cl)cc(Cl)cc54)c3)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: 1 mg AZD1722 bid

AZD1722: tenapanor, oral tablet
Eligibility criteria:
Inclusion Criteria:

Females and males aged ≥18 years
Chronic maintenance hemodialysis 3 x/week for a at least 3 months
Prescribed and taking at least 3 doses of phosphate binder per day
Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening
Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening
For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out

Exclusion Criteria:

Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit.
Serum parathyroid hormone >1200 pg/mL
Significant metabolic acidosis

Clinical signs of hypovolemia at randomization

-
Intervention: Tenapanor
Trial phase: Phase 2
ATC code: A06AX08
SMILES: CN1Cc2c(Cl)cc(Cl)cc2[C@H](c2cccc(S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)c3cccc([C@@H]4CN(C)Cc5c(Cl)cc(Cl)cc54)c3)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: 3 mg AZD1722 bid

AZD1722: tenapanor, oral tablet
Eligibility criteria:
Inclusion Criteria:

Females and males aged ≥18 years
Chronic maintenance hemodialysis 3 x/week for a at least 3 months
Prescribed and taking at least 3 doses of phosphate binder per day
Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening
Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening
For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out

Exclusion Criteria:

Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit.
Serum parathyroid hormone >1200 pg/mL
Significant metabolic acidosis

Clinical signs of hypovolemia at randomization

-
Intervention: Tenapanor
Trial phase: Phase 2
ATC code: A06AX08
SMILES: CN1Cc2c(Cl)cc(Cl)cc2[C@H](c2cccc(S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)c3cccc([C@@H]4CN(C)Cc5c(Cl)cc(Cl)cc54)c3)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: 10 mg AZD1722 bid

AZD1722: tenapanor, oral tablet
Eligibility criteria:
Inclusion Criteria:

Females and males aged ≥18 years
Chronic maintenance hemodialysis 3 x/week for a at least 3 months
Prescribed and taking at least 3 doses of phosphate binder per day
Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening
Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening
For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out

Exclusion Criteria:

Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit.
Serum parathyroid hormone >1200 pg/mL
Significant metabolic acidosis

Clinical signs of hypovolemia at randomization

-
Intervention: Tenapanor
Trial phase: Phase 2
ATC code: A06AX08
SMILES: CN1Cc2c(Cl)cc(Cl)cc2[C@H](c2cccc(S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)c3cccc([C@@H]4CN(C)Cc5c(Cl)cc(Cl)cc54)c3)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: 30 mg AZD1722 bid

AZD1722: tenapanor, oral tablet
Eligibility criteria:
Inclusion Criteria:

Females and males aged ≥18 years
Chronic maintenance hemodialysis 3 x/week for a at least 3 months
Prescribed and taking at least 3 doses of phosphate binder per day
Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening
Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening
For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out

Exclusion Criteria:

Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit.
Serum parathyroid hormone >1200 pg/mL
Significant metabolic acidosis

Clinical signs of hypovolemia at randomization

-
Intervention: Tenapanor
Trial phase: Phase 2
ATC code: A06AX08
SMILES: CN1Cc2c(Cl)cc(Cl)cc2[C@H](c2cccc(S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)c3cccc([C@@H]4CN(C)Cc5c(Cl)cc(Cl)cc54)c3)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 22
Group description: 3 mg AZD1722 od

AZD1722: tenapanor, oral tablet
Eligibility criteria:
Inclusion Criteria:

Females and males aged ≥18 years
Chronic maintenance hemodialysis 3 x/week for a at least 3 months
Prescribed and taking at least 3 doses of phosphate binder per day
Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening
Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening
For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out

Exclusion Criteria:

Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit.
Serum parathyroid hormone >1200 pg/mL
Significant metabolic acidosis

Clinical signs of hypovolemia at randomization

-
Intervention: Tenapanor
Trial phase: Phase 2
ATC code: A06AX08
SMILES: CN1Cc2c(Cl)cc(Cl)cc2[C@H](c2cccc(S(=O)(=O)NCCOCCOCCNC(=O)NCCCCNC(=O)NCCOCCOCCNS(=O)(=O)c3cccc([C@@H]4CN(C)Cc5c(Cl)cc(Cl)cc54)c3)c2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: 30 mg AZD1722 od

AZD1722: tenapanor, oral tablet
Eligibility criteria:
Inclusion Criteria:

Females and males aged ≥18 years
Chronic maintenance hemodialysis 3 x/week for a at least 3 months
Prescribed and taking at least 3 doses of phosphate binder per day
Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening
Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening
For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out

Exclusion Criteria:

Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit.
Serum parathyroid hormone >1200 pg/mL
Significant metabolic acidosis

Clinical signs of hypovolemia at randomization

-
Intervention: Amikacin
Trial phase: Phase 4
ATC code: D06AX12 | J01GB06 | J01RA06 | S01AA21
SMILES: NCC[C@H](O)C(=O)N[C@@H]1C[C@H](N)[C@@H](O[C@H]2O[C@H](CN)[C@@H](O)[C@H](O)[C@H]2O)[C@H](O)[C@H]1O[C@H]1O[C@H](CO)[C@@H](O)[C@H](N)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: Participants receive nebulized amikacin BID for 14 days in combination with standard treatment.

Amikacin: Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment.
Eligibility criteria:
Inclusion Criteria:

Male or female study subjects ≥18 years of age and ≤80 years of age;
Confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis;
Confirmation of infection with Pseudomonas aeruginosa at screening;
Are sensitive to amikacin;
Acute exacerbation of bronchiectasis.

Exclusion Criteria:

Bronchiectasis due to special causes;
Smokers;
Are associated with bronchial asthma;
Have any serious or active medical or psychiatric illness;
Be allergic to amikacin or not tolerant to nebulised amikacin(FEV1 reduces ≥15% after inhaling amikacin.
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: 73
Group description: Participants received nebulized normal saline BID for 14 days in combination with standard treatment.

Normal saline: Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment.
Eligibility criteria:
Inclusion Criteria:

Male or female study subjects ≥18 years of age and ≤80 years of age;
Confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis;
Confirmation of infection with Pseudomonas aeruginosa at screening;
Are sensitive to amikacin;
Acute exacerbation of bronchiectasis.

Exclusion Criteria:

Bronchiectasis due to special causes;
Smokers;
Are associated with bronchial asthma;
Have any serious or active medical or psychiatric illness;
Be allergic to amikacin or not tolerant to nebulised amikacin(FEV1 reduces ≥15% after inhaling amikacin.
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: 35
Group description: Ondansetron will be given 0.5 mg/ BID. The dose may be increased from 0.5 mg/BID to 1.0 mg/BID at week 4 for participants with less than 30% reduction in HAMD and/or alcohol use. An additional dose increase to 2.0 mg/BID and 4.0 mg/BID is allowed at weeks 8 and 10, respectively, for participants with less than a 50% reduction in HAMD scores and/or alcohol use.

Ondansetron: Ondansetron is a serotonin receptor antagonist that is FDA-approved to treat nausea and vomiting caused by cancer therapy and surgery.
Eligibility criteria:
Inclusion Criteria:

Outpatient men and women age 18-70 years old with bipolar I, II, or Not Otherwise Specified (NOS) disorders, schizoaffective disorder (bipolar type), cyclothymic disorder, or major depressive disorder with mixed features
Current diagnosis of alcohol use disorder (DSM V terminology) with onset ≤ age 25
Alcohol use (by self-report) of at least 15 drinks in the 7 days prior to intake
IF diagnosis of Bipolar I, II, or NOS Disorder: Current mood stabilizer therapy (lithium, anticonvulsant, atypical antipsychotic) with stable dose for at least 14 days prior to randomization
IF diagnosis of Schizoaffective disorder (bipolar type): Current atypical antipsychotic therapy with stable dose for at least 14 days prior to randomization
IF diagnosis of Major Depressive Disorder with mixed features: Current antidepressant therapy with stable dose for at least 14 days prior to randomization

Exclusion Criteria:

Baseline Young Mania Rating Scale (YMRS) or Hamilton Rating Scale for Depression (HAMD) scores ≥ 35 to exclude those with very severe mood symptoms
Evidence of clinically significant alcohol withdrawal symptoms defined as a CIWA-Ar (Clinical Institute Withdrawal Assessment of Alcohol Use-Revised) score of ≥ 10
Therapy in past 14 days with naltrexone, acamprosate, disulfiram, or topiramate
Vulnerable populations (e.g. pregnant, breastfeeding, incarcerated, cognitively impaired (e.g. dementia, mentally challenged))
High risk of suicide defined as > 1 attempt in past 12 months that required medical attention, any attempt in the past 3 months or current suicidal ideation with plan and intent such that outpatient care is precluded
Intensive outpatient treatment (defined as ≥ 3 visits each week) for substance abuse (AA, NA meetings, or less intensive counseling at baseline will be allowed)
Severe or life-threatening medical condition (e.g., hepatic cirrhosis) or laboratory or physical examination findings consistent with serious medical illness (e.g., dangerously abnormal electrolytes)
AST (aspartate aminotransferase ) or ALT (alanine transaminase) > 3 times the upper limit of normal
History of severe side effects or allergic reaction with prior ondansetron therapy (e.g. for vomiting) or use of medications with significant drug-drug interactions with ondansetron (phenytoin, carbamazepine, and rifampicin, apomorphine, tramadol)
Intervention: OXYTOCIN
Trial phase: Not Applicable
ATC code: H01BB02
SMILES: CC[C@H](C)[C@@H]1NC(=O)[C@H](Cc2ccc(O)cc2)NC(=O)[C@@H](N)CSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CC(C)C)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC(=O)[C@H](CCC(N)=O)NC1=O
Sex: Female
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 82
Group description: Intravenous oxytocin mixed with saline or lactated ringer

intravenous oxytocin: 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)
Eligibility criteria:
Inclusion Criteria:

Requesting pregnancy termination
Intrauterine pregnancy at 18- to 24-weeks gestation
Gestational-age to be confirmed by ultrasound
Patients with fetal anomaly or intrauterine fetal demise that occurred at 18- to 24-weeks gestation
Willing and able to understand and sign written informed consents in English or Spanish and comply with study procedures

Exclusion Criteria:

Ultrasound findings suggestive of placenta accreta
Patients requiring preoperative misoprostol