anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sucrose
Trial phase: Phase 1 | Phase 2
SMILES: OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 10
Group description: Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization

sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks
Eligibility criteria:
Inclusion Criteria:

Evidence for ROP that might progress and that includes any one of the following:

Stage 1 (zone I)
Stage 2 or higher (zones I, II or III), or Plus disease. The classification of ROP is according to International Classification of Retinopathy of Prematurity (ICROP) 2005 (40) (Appendix I, with scheme of retina showing zones and clock hours).Zone III ROP is not included since it will always regress spontaneously.

Exclusion Criteria:

The presence of one or more of the following conditions at enrollment in the study:
More than 10 episodes of bradycardia of prematurity/day (HR< 90 bpm) [
Atrio-ventricular (A-V) block [2nd or 3rd degree]
Significant congenital heart anomaly [not including patent ductus arteriosus, patent foramen ovale or small ventricular septal defect]
Heart failure
Hypotension (mean blood pressure <45 mmHg)
Hypoglycemia (<50mg/dL)
Platelet count <100000/mm3
Intervention: Levetiracetam
Trial phase: Phase 1 | Phase 2
ATC code: N03AX14
SMILES: CCC(C(N)=O)N1CCCC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 7
Group description: Single arm, 50 mg/kg of levetiracetam
Eligibility criteria:
Inclusion Criteria:

Gestational age ≥ 32 weeks
Postnatal age ≤ 30 days
Birth weight ≥ 2000 grams
Admitted to the Neonatal Intensive Care Unit at Cincinnati Children's Hospital
Clinical or electrographic seizures of any etiology
Seizures or seizure prophylaxis requiring treatment with levetiracetam
Parental consent obtained

Exclusion Criteria:

Infants with renal insufficiency indicated by serum creatinine > 2.0 at any time
Infants who have previously received levetiracetam
Parents refuse consent
Attending physician does not wish the infant to be enrolled in the study
Infants who are currently receiving an investigational drug
Intervention: Asenapine
Trial phase: Phase 3
ATC code: N05AH05
SMILES: CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 157
Group description: All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
Eligibility criteria:
Inclusion Criteria:

Minimum age of 20 years

Participants who meet at least one of the following:

current diagnosis of schizophrenia of residual subtype
received treatment with 3 or more antipsychotic drugs
treatment-refractory participants with schizophrenia
65 years old and over with positive schizophrenia symptoms with score of 3 (mild) or more in 1 or more items in the positive subscale of the Positive and Negative Syndrome Scale (PANSS) at the baseline
Participants who have a Clinical Global Impressions-Severity (CGI-S) score of at least 4 (moderately ill) at the baseline

Exclusion Criteria:

Uncontrolled, unstable clinically significant medical condition
Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings at Screening
Positive pregnancy test at Screening, or the intention to become pregnant during the course of the study
Seizure disorder beyond childhood (12 years old or younger)
History of neuroleptic malignant syndrome
Allergy or sensitivity to drugs such as psychotropics and antipsychotics
Known history of or currently treated for narrow angle glaucoma
Parkinson's disease
Diagnosis of schizoaffective disorder; schizophreniform disorder
Concurrent psychiatric disorder other than schizophrenia coded on Axis I; a primary diagnosis other than schizophrenia
Diagnosis of borderline personality disorder
Diagnosis of mental retardation or organic brain disorder
Current (past 6 months) substance abuse or dependence according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (excluding nicotine)
Positive drug/alcohol tests at the Screening visit
Imminent risk of self-harm or harm to others, in the Investigator's opinion
Substance induced psychotic disorder or a behavioral disturbance thought to be due to substance abuse
Currently under involuntary inpatient confinement
Use of a non-approved drug in Japan within 12 weeks prior to informed consent
Previously treated in an asenapine study
Intervention: 11beta-Hydroxyandrostenedione
Trial phase: Phase 3
SMILES: CC12CC(O)C3C(CCC4=CC(=O)CCC43C)C1CCC2=O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Single oral administration of NPC-01

NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
Eligibility criteria:
Inclusion Criteria:

Healthy female aged between 20 to 35 years
BMI:18.0-26.0

Exclusion Criteria:

Females who are pregnant
Drug use affecting sex hormone secretion
Intervention: Bisoprolol
Trial phase: Phase 4
ATC code: C07AB07 | C07BB07 | C07FB07 | C07FX04 | C09BX02 | C09BX04 | C09BX05
SMILES: CC(C)NCC(O)COc1ccc(COCCOC(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 86
Group description: Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
Eligibility criteria:
Inclusion Criteria:

Subjects aged between 25-65 years
Subjects with essential hypertension (EH)
Subjects with systolic blood pressure (SBP) 140-160 millimeter of mercury (mmHg) and diastolic blood pressure (DBP) 90-100 mmHg
Subjects with normal sinus rhythm
Subjects with resting heart rate (RHR) greater than 70 bpm
Subjects who give written informed consent

Exclusion Criteria:

Subjects with atrial fibrillation (AF)/sick sinus syndrome (SSS)/atrioventricular block II-III Grade (AVB II-III) without pacemaker
Subjects with bradyarrhythmia/hypotension
Subjects with unstable angina pectoris (UAP)/acute myocardial infarction (AMI)/heart failure (HF) (New York Heart Association [NYHA] Class III - IV)
Subjects with uncontrolled diabetes mellitus (DM)
Subjects with bronchial asthma
Subjects with gastro-intestinal ulcer or skin ulcer
Subjects with liver dysfunction/renal impairment
Subjects treated with calcium channel blockers (except amlodipine) or other beta-blockers.
Subjects with glaucoma
Subjects with known allergic/intolerance to beta-blocker
Pregnant or lactating women
Subjects who had participated in another clinical study within the last 3 months
Subjects who have legal incapacity or limited legal capacity
Intervention: Irosustat
Trial phase: Phase 2
SMILES: NS(=O)(=O)Oc1ccc2c3c(c(=O)oc2c1)CCCCC3
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
Eligibility criteria:
Inclusion Criteria:

Provision of written informed consent prior to any study related procedures.
postmenopausal or ovariectomised female patient over 18 years of age.
histologically confirmed diagnosis of ER positive endometrial carcinoma in the primary tumour or metastatic disease
patient has received one line of chemotherapy prior to enrolment in the adjuvant or in the metastatic setting (including chemoradiotherapy) and progressed after this line of chemotherapy
patient has at least one measurable disease site (RECIST criteria version 1.1)

Exclusion Criteria:

patient has received hormone therapy for endometrial cancer in the adjuvant or metastatic setting
patient has received more than one line of chemotherapy in the adjuvant or metastatic setting
patient was treated with any other investigational agent within the 3 weeks before study entry.
patient has ongoing cardiac dysrhythmias grade ≥2, atrial fibrillation of any grade (NCI CTCAE) or QTcF interval >460 msec.
Intervention: 11beta-Hydroxyandrostenedione
Trial phase: Phase 3
SMILES: CC12CC(O)C3C(CCC4=CC(=O)CCC43C)C1CCC2=O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 7
Group description: 1mg norethisterone and 0.02mg ethinyl estradiol

NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol
Eligibility criteria:
Inclusion Criteria:

Healthy female aged between 20 to 35 years
BMI:18.0-26.0

Exclusion Criteria:

Females who are pregnant
Drug use affecting sex hormone secretion
Intervention: Travoprost
Trial phase: Phase 4
ATC code: S01EE04
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)COc2cccc(C(F)(F)F)c2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of ocular hypertension or open-angle glaucoma in at least 1 eye requiring treatment with an anti-glaucoma/ocular hypertensive medication
Best corrected visual acuity score of 20/100 or better in both eyes
Females on birth control pills must be on same type of pill and dose for at least 3 month

Exclusion Criteria:

Use of Lumigan® 0.01%/Lumigan® RC, Lumigan®, Travatan® or Travatan Z® within 6 months
History of or active ocular infection/inflammation (eg, uveitis)
Punctal plug use
Required use of ocular medications during the study other than study medication (intermittent use of certain types artificial tears acceptable)
Intraocular surgery or glaucoma laser surgery in study eye(s) within 3 months
History of corneal refractive laser surgery (eg, LASIK, LASEK) in study eye(s)
Planned contact lens wear during study
Intervention: Drospirenone
Trial phase: Phase 3
ATC code: G03AA12 | G03AA18 | G03AC10 | G03FA17
SMILES: [H][C@]12C[C@@]1([H])[C@]1([H])[C@](C)(CC[C@@]3([H])[C@@]1([H])[C@@]1([H])C[C@@]1([H])C1=CC(=O)CC[C@@]13C)[C@]21CCC(=O)O1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 281
Group description: Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
Eligibility criteria:
Inclusion Criteria:

Subject has signed and dated the Informed Consent Form (ICF).
The subject is generally healthy, requesting contraception, and is between 18 and 29 years of age (inclusive) at Screening.

In the opinion of the investigator, the subject is

in good health;
without uterine conditions that would preempt insertion of LCS12;
without conditions/history that would contraindicate the use of oral contraceptives.
Subject has normal or clinically insignificant cervical smear (ie, one that does not require further follow up). A cervical smear must be taken at the Screening Visit or a documented normal result has to have been obtained within 6 months of Screening. Subjects with atypical squamous cells of undetermined significance (ASCUS) can be included in the study if they have a Human Papilloma Virus (HPV) deoxyribonucleic acid (DNA) test that, according to the standards of the local laboratory, is negative for high-risk HPV.
As determined by subject's history, subject has regular (ie, endogenous cyclicity without hormonal contraceptive use) menstrual cycles (length of cycle 21-35 days).
Subject is willing and able to attend the scheduled study visits and to comply with the study procedures.

Exclusion Criteria:

Pregnancy or current lactation (less than 6 weeks since vaginal or Cesarean delivery or abortion). Note: Postpartum LCS12 insertions should be postponed until the uterus is fully involuted, and not earlier than 6 weeks after delivery. If involution is substantially delayed, the investigator should consider waiting until 12 weeks postpartum.
Infected abortion or postpartum endometritis within 3 months prior to the Screening Visit (Visit 1)
Chronic, daily use of drugs that may increase serum potassium levels, such as nonsteroidal anti-inflammatory drugs (NSAIDs, eg. ibuprofen and naproxen), potassium-sparing diuretics (eg. spironolactone), potassium supplementation, angiotensin converting enzyme (ACE) inhibitors, angiotensin-II receptor antagonists, aldosterone antagonists, and heparin.
Abnormal uterine bleeding of unknown origin/undiagnosed abnormal genital bleeding
Any genital infection (until successfully treated)
Abnormal cervical smear result (see inclusion criteria)
Acute, current or history of recurrent pelvic inflammatory disease
Congenital or acquired uterine anomaly or any distortion of the uterine cavity (eg, by fibroids) that, in the opinion of the investigator, would cause problems during insertion, retention, or removal of LCS12.
Intervention: Zoledronic acid
Trial phase: Phase 4
ATC code: M05BA08 | M05BB08
SMILES: O=P(O)(O)C(O)(Cn1ccnc1)P(=O)(O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: Zoledronic acid: Zoledronic acid per protocol
Eligibility criteria:
Inclusion Criteria:

Patients undergoing primary elective total hip replacement

Exclusion Criteria:

Osteoporosis (BMD ≤-2.5)
Trauma to the operated femur, hip revisions, femoral dysplasia, trochanteric osteotomy, inflammatory arthritis
Severe renal impairment
Use of any medications affecting BMD
Known sensitivity to bisphosphonates
Severe dental problems, and pregnancy or being able to conceive and not using reliable birth control methods
Intervention: Ergocalciferol
Trial phase: Phase 1
ATC code: A11CC01
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)/C=C/[C@H](C)C(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: ERgocalcifoerol 50,000 units q weekly for 8 weeks
Eligibility criteria:
Inclusion Criteria:

1. Age 18-60 years 2. No known medical illnesses requiring pharmacotherapy 3. Not on any mineral or vitamin supplements in the last 3 months

Exclusion Criteria:

1. Subjects requiring prompt initiation of pharmacotherapy, such as those with incidentally discovered diabetes mellitus or hypertension.

2. Previous administration of glucocorticoids, retinoic acid derivatives, or insulin sensitizers in the preceding 3 months.

3. Bariatric surgery or liposuction 4. Unintentional weight loss >5% of the body weight in last 3 months 5. Chronic smokers (> 1 pk/d for 10 years) 6. Alcohol use > 2 drinks/day
Intervention: PRAMLINTIDE
Trial phase: Phase 4
ATC code: A10BX05
SMILES: [H]N[C@@H](CCCCN)C(=O)N[C@H]1CSSC[C@@H](C(=O)N[C@@H](C)C(=O)N[C@]([H])(C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](Cc2ccccc2)C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](C(=O)N[C@@H](Cc2cnc[nH]2)C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](Cc2ccccc2)C(=O)NCC(=O)N2CCC[C@H]2C(=O)N[C@]([H])(C(=O)N[C@@H](CC(C)C)C(=O)N2CCC[C@H]2C(=O)N2CCC[C@H]2C(=O)N[C@]([H])(C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H](C(=O)NCC(=O)N[C@@H](CO)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@]([H])(C(=O)N[C@@H](Cc2ccc(O)cc2)C(N)=O)[C@@H](C)O)C(C)C)[C@@H](C)O)[C@@H](C)CC)C(C)C)[C@@H](C)O)NC(=O)[C@]([H])([C@@H](C)O)NC(=O)[C@H](C)NC(=O)[C@]([H])([C@@H](C)O)NC(=O)[C@H](CC(N)=O)NC1=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 13
Group description: These kids will get Pramlintide (Symlin) along with insulin before breakfast and supper.

Pramlintide: Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months
Eligibility criteria:
Inclusion Criteria:

Age of 12 to 21 years.
HbA1C less than 9%
Subjects must be on intensive insulin management
Tanner stage greater than or equal to 3
Having Type 1 Diabetes for at least one year
Type 1Diabetes defined by ADA criteria and having at least one of the following antibodies a. Anti-GAD (glutamic acid decarboxylase) b. Anti-islet cell 512 (ICA512) c. Anti-insulin
Willing to give consent.

Exclusion Criteria:

Type 2 diabetes.
Having any other chronic condition except hypothyroidism stable on medications.
On chronic medications that may affect glucose excursions.
Anemia as defined as Hb less than 9 gm/dl.
Abnormal amylase, lipase or creatinine (twice normal).
Abnormal Liver function tests(three times above normal)
Unsupportive family environment as determined by clinicians and/or social workers.
Pregnant or lactating mothers
Intervention: Dexmedetomidine
Trial phase: Not Applicable
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 142
Group description: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.

Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
Eligibility criteria:
Inclusion Criteria:

Patients who undergo general anesthesia for elective surgical excision of a brain tumor with following specifications:

Age: Older than 18
Primary and redo cases will be included
Duration of surgery not exceeding 6 hrs.

Exclusion Criteria:

Patient refusal
Emergency craniotomy
Morbid obesity
Uncontrolled hypertension - DBP more than 110
Cardiac conduction defects
Patients with chronic pain.
Intervention: Diclofenac sodium
Trial phase: Phase 3
SMILES: O=C([O-])Cc1ccccc1Nc1c(Cl)cccc1Cl.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 102
Group description: Diclofenac sodium topical gel 1%

Diclofenac Sodium : Topical gel 1%-4 times daily
Eligibility criteria:
Inclusion Criteria:

Male or female aged 18 years and over.Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level. Injury within past 12 hours.

Exclusion Criteria:

Pain medication was taken within the 6 hours that precede randomization.During the past 3 months: Grade I-III sprain of the same ankle.During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot.Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).
Intervention: Drospirenone
Trial phase: Phase 3
ATC code: G03AA12 | G03AA18 | G03AC10 | G03FA17
SMILES: [H][C@]12C[C@@]1([H])[C@]1([H])[C@](C)(CC[C@@]3([H])[C@@]1([H])[C@@]1([H])C[C@@]1([H])C1=CC(=O)CC[C@@]13C)[C@]21CCC(=O)O1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 232
Group description: Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
Eligibility criteria:
Key Inclusion Criteria:

Sexually active Chinese women, at risk for pregnancy and not planning to use condoms during trial medication use
Women in need for contraception and willing to use a hormonal contraceptive method for 13 cycles
Body mass index ≥18 and ≤29 kg/m^2

Key Exclusion Criteria:

Contraindications for contraceptive steroids
Abnormal cervical smear corresponding to indeterminate changes at screening
Clinically relevant abnormal laboratory result at screening as judged by the investigator.
Intervention: Misoprostol
Trial phase: Phase 2
ATC code: A02BB01 | G02AD06 | M01AE56
SMILES: CCCCC(C)(O)C/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1CCCCCCC(=O)OC
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
Eligibility criteria:
Inclusion Criteria:

Provide written informed consent;
Pregnant women at ≥ 36 weeks 0 days inclusive gestation;
Women aged 18 years or older;
Candidate for pharmacologic induction of labor;
Single, live vertex fetus;
Baseline modified Bishop score ≤ 4;
Parity ≤ 3 (parity is defined as one or more births live or dead after 24 weeks gestation);
Body Mass Index (BMI) ≤ 50 at the time of entry to the study.

Exclusion Criteria:

Women with hemoglobin level < 10.0 grams per deciliter (g/dL) (confirmed within one week of study drug insertion);
Women in active labor;
Presence of uterine or cervical scar or uterine abnormality e.g., bicornate uterus. Biopsies, including cone biopsy of the cervix, are permitted;
Administration of oxytocin or any cervical ripening or labor inducing agents (including mechanical methods) or a tocolytic drug within 7 days prior to enrollment. Magnesium sulfate is permitted if prescribed as treatment for pre-eclampsia or gestational hypertension;
Severe pre-eclampsia marked by Hemolytic anemia, Elevated Liver enzymes, Low Platelet count (HELLP) syndrome, other end-organ affliction or Central Nervous System (CNS) findings other than mild headache;
Fetal malpresentation;
Diagnosed congenital anomalies, not including polydactyly;
Any evidence of fetal compromise at baseline (e.g., non-reassuring fetal heart rate pattern or meconium staining);
Amnioinfusion or other treatment of non-reassuring fetal status at any time prior to the induction attempt;
Ruptured membranes ≥ 48 hours prior to the start of treatment;
Suspected chorioamnionitis;
Fever (oral or aural temperature > 37.5°C);
Any condition in which vaginal delivery is contraindicated e.g., placenta previa or any unexplained genital bleeding at any time after 24 weeks during this pregnancy;
Known or suspected allergy to misoprostol, other prostaglandins or any of the excipients;
Any condition urgently requiring delivery;
Unable to comply with the protocol.