anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lidocaine
Trial phase: Phase 2 | Phase 3
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Lidocaine

Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours
Eligibility criteria:
Inclusion Criteria:

Male or female patients 18 years of age or older
In or outpatients referred to the BCCA PSMPC Clinics with a diagnosis of cancer
Subjects must have somatic, visceral or neuropathic pain related to cancer
Pain intensity, measured by a worst pain score over the last 72 hours of ≥4 on a 0-10 numerical rating scale
Must have tried at least one opioid medication without adequate response or with significant side-effects for at least one week
For those with neuropathic pain, must have also tried at least one adjuvant analgesic, such as a tricyclic (unless contraindicated) or an anticonvulsant without adequate response or with significant side-effects for at least one week
Life expectancy of > 3 months
Must be able to communicate symptoms indicating potential toxicity of Lidocaine
Must have a competent caregiver in the home overnight after each infusion
Must be willing to remain within 30 minutes of the Cancer Centre during each infusion

Exclusion Criteria:

Clinically significant cardiac disease, i.e, cardiac failure, atrial fibrillation with slow ventricular rate (<60), any degree of heart block
New analgesic treatment initiated in time frame which might have effect within one week of study drug.
Hyper or hypokalemia.
Liver failure (bilirubin ≥ 25 umol/L).
Renal failure (eGFR <50% of normal)
Uncontrolled hypertension (>160/90).
Hypotension (systolic < 90).
Uncontrolled seizures.
Planned initiation of chemotherapy, radiotherapy or bisphosphonates within 30 days prior to treatment with study drug.
Received an investigational drug within 30 days prior to study.
History of allergy to lidocaine or other topical, local or infusional anesthetics.
Intervention: Enclomiphene
Trial phase: Phase 2
ATC code: G03GB02
SMILES: CCN(CC)CCOc1ccc(C(=C(Cl)c2ccccc2)c2ccccc2)cc1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: enclomiphene citrate: capsule oral

1X a day 6 weeks
Eligibility criteria:
Inclusion Criteria:

Healthy males between the ages of 18 and 65 years of age exhibiting morning testosterone ≤350 ng/dL.
All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
Ability to complete the study in compliance with the protocol
Ability to understand and provide written informed consent
Agreement to use a condom, and with a fertile female partner, another form of contraception.
Agreement to provide a semen sample in the clinic

Exclusion Criteria:

Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3 months prior to study
Use of spironolactone, cimetidine, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
Use of Clomid in the past year or during the study
Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes but exhibiting glycemic control will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study.
A hematocrit ≥51 % or a hemoglobin ≥17 g/dL
Clinically significant abnormal findings on screening examination
Use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication
Known hypersensitivity to Clomid
Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study
Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary)
History of breast cancer
History of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA >3.6
History of known hyperprolactinemia with or without a tumor
Chronic use of medications use such as glucocorticoids
Chronic use of narcotics
Subjects known to be positive for HIV
Subjects with end stage renal disease
Subjects with cystic fibrosis (mutation of the CFTR gene)
Subjects unable to provide a semen sample in the clinic
Subject has a BMI >42 kg/m2
Intervention: Enclomiphene
Trial phase: Phase 2
ATC code: G03GB02
SMILES: CCN(CC)CCOc1ccc(C(=C(Cl)c2ccccc2)c2ccccc2)cc1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: enclomiphene citrate: capsule oral

1X a day 6 weeks
Eligibility criteria:
Inclusion Criteria:

Healthy males between the ages of 18 and 65 years of age exhibiting morning testosterone ≤350 ng/dL.
All clinical laboratory tests within normal ranges (any clinically significant deviation of laboratory results will require approval of sponsor)
Ability to complete the study in compliance with the protocol
Ability to understand and provide written informed consent
Agreement to use a condom, and with a fertile female partner, another form of contraception.
Agreement to provide a semen sample in the clinic

Exclusion Criteria:

Use of an injectable, oral, topical, or subcutaneous pelleted testosterone within 3 months prior to study
Use of spironolactone, cimetidine, 5α-reductase inhibitors, hCG, androgen, estrogen, anabolic steroid, DHEA, or herbal hormone products during the study
Use of Clomid in the past year or during the study
Uncontrolled hypertension or diabetes mellitus based on the Investigator's assessment at baseline. Subjects treated for Type II diabetes but exhibiting glycemic control will be allowed into the study. Newly diagnosed diabetics need to be treated for at least 48 hours before being enrolled in the study.
A hematocrit ≥51 % or a hemoglobin ≥17 g/dL
Clinically significant abnormal findings on screening examination
Use of an investigational drug or product, or participation in a drug or medical device research study within 30 days prior to receiving study medication
Known hypersensitivity to Clomid
Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, possibly confound interpretation of study results, or endanger the participant if he took part in the study
Irreversibly infertile or compromised fertility (cryptorchism, Kallman Syndrome, primary hypogonadism, vasectomy, or tumors of the pituitary)
History of breast cancer
History of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA >3.6
History of known hyperprolactinemia with or without a tumor
Chronic use of medications use such as glucocorticoids
Chronic use of narcotics
Subjects known to be positive for HIV
Subjects with end stage renal disease
Subjects with cystic fibrosis (mutation of the CFTR gene)
Subjects unable to provide a semen sample in the clinic
Subject has a BMI >42 kg/m2
Intervention: Acetylcysteine
Trial phase: Not Applicable
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: high glycemic index diet plus N-acetylcysteine

high glycemic index diet plus N-acetylcysteine: Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable high glycemic index diet (glycemic index >70) for 4 weeks, all food provided by the Human Nutrition Lab. They will take N-acetylcysteine (NAC) two 600 mg capsules twice daily for the 4 weeks on the high GI diet. The NAC vs. placebo arms (arms 2 and 3) will be double-blinded.
Eligibility criteria:
Inclusion Criteria:

impaired glucose tolerance (2 hour glucose 140-200 mg/dl after a standard 75 grams oral glucose tolerance test [OGTT]) or
fasting glucose 100-115 mg/dl and 2 hour glucose > 100 mg/dl after a standard OGTT

Exclusion Criteria:

diabetes or taking diabetes medications
fasting glucose >115 mg/dl
alanine aminotransferase (ALT) >1.5 times the upper limit of normal
hematocrit <33%
serum creatinine >1.5 men or >1.3 women
multiple food allergies or intolerances
other serious medical or inflammatory conditions
pregnancy or lactation
smoke or use tobacco
take medications that affect insulin sensitivity and secretion (niacin, diabetes medications or glucocorticoids) or inflammation (anti-inflammatories such as ibuprofen, naprosyn, aspirin)
significant gastroesophageal reflux (heartburn), swallowing problems or stomach ulcers, including those taking medication for these indications
taking or having taken another investigational drug within the past 30 days
Intervention: Thymosin Beta 4
Trial phase: Phase 2
SMILES: CCC(C)C(NC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(CCSC)NC(=O)C(CC(=O)O)NC(=O)C1CCCN1C(=O)C(CCCCN)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(C)=O)C(=O)NC(CCC(=O)O)C(=O)NC(CCCCN)C(=O)NC(Cc1ccccc1)C(=O)NC(CC(=O)O)C(=O)NC(CCCCN)C(=O)NC(CO)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CCCCN)C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(C(=O)NC(CCC(N)=O)C(=O)NC(CCC(=O)O)C(=O)NC(CCCCN)C(=O)NC(CC(N)=O)C(=O)N1CCCC1C(=O)NC(CC(C)C)C(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CCCCN)C(=O)NC(CCC(=O)O)C(=O)NC(C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC(CCC(=O)O)C(=O)NC(CCCCN)C(=O)NC(CCC(N)=O)C(=O)NC(C)C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CO)C(=O)O)C(C)CC)C(C)O)C(C)O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 36
Group description: RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4

Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
Eligibility criteria:
Inclusion Criteria:

Have given a written, informed consent.
Be able and willing to follow instructions, including participation in study assessments, and be present for the required study visits for the duration of the study.
Have a best corrected visual acuity.
Have a patient-reported history of dry eye in both eyes.
Use and/or desire to use an artificial tear substitute for dry eye symptoms within the past 6 months.
A negative urine pregnancy test if female of childbearing potential.

Have a corneal fluorescein staining score of ≥ 2 in any corneal surface segment in at least one eye at Visit 1.

-

Exclusion Criteria:

Have contraindications to the use of the study drug.
Have known allergy or sensitivity to the study drug or components thereof.
Have anterior blepharitis.
Be diagnosed with an on-going ocular infection or active ocular inflammation.
Use contact lenses within 1 week before Visit 1 or during the course of the study.
Have previously had Laser-Assisted in Situ Keratomileusis (LASIK) surgery within 12 months prior to Visit 1.
Be currently taking any topical ophthalmic prescription or over-the-counter (OTC) solutions, artificial tears, gels, or scrubs and cannot discontinue these medications for the duration of the trial.
Have used topical ocular cyclosporine within 30 days prior to Visit 1.
Have had a past or present evidence of malignancy.
Intervention: Bromfenac
Trial phase: Phase 2
ATC code: S01BC11
SMILES: Nc1c(CC(=O)O)cccc1C(=O)c1ccc(Br)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 60
Group description: 0.075% bromfenac in DuraSite vehicle dosed QD
Eligibility criteria:
Inclusion Criteria:

Male or female subjects age 18 or older scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation
If a female is of childbearing potential, the subject must agree to and submit a urine sample for pregnancy testing at Visit 1 prior to enrollment and at the end of the study, and the subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months.
Signature of the subject on the Informed Consent Form
Willing and able to follow all instructions and attend all study visits
Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)

Exclusion Criteria:

Use of any drug containing bromfenac within 2 weeks prior to surgery
Contact lens wear during the dosing period
Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the investigational medicinal product (IMP) or any of the procedural medications
Any serious complications with or macroscopic damage to the corneal epithelium
Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test
Currently suffer from alcohol and/or drug abuse
Prior participation in this study protocol
Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
Intervention: Pregabalin
Trial phase: Phase 3
ATC code: N02BF02 | N03AX16
SMILES: CC(C)C[C@H](CN)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 170
Group description: Pregabalin was administered orally, at a dose level of 75 mg (1 capsule) twice daily (BID) (Day 0 evening - Day 7 morning) and 150 mg (1 capsule) BID (Day 7 evening - Day 14 morning) in the titration phase.

Pregabalin was then administered at a dose level of 150 mg (1 capsule) BID or 225 mg (2 capsules; 75 mg + 150 mg) BID in Day 14 evening and Weeks 3 - 14 during the fixed-dose phase. A 1-week taper off dose phase was in the following with pregabalin 150 mg or 225 mg administered in the morning and 75 mg administered in the evening.
Eligibility criteria:
Inclusion Criteria:

Male or female patients, at least 18 years of age
Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
At screening (V1) and randomization (V2), patients must have a score of no less than 40 mm on the Pain Visual Analog Scale (VAS)
At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be no less than 4

Exclusion Criteria:

Patients with no less than 30% decrease on the Pain Visual Analog Scale (VAS) at randomization (V2) as compared to screening (V1)
Patients with other severe pain due to other conditions (eg, DPN or PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia
Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders
CLcr less than 60 mL/min (estimated from serum creatinine)
Intervention: Egrifta
Trial phase: Phase 2
ATC code: H01AC06
SMILES: CCC=CCC(=O)NC(Cc1ccc(O)cc1)C(=O)NC(C)C(=O)NC(CC(=O)O)C(=O)NC(C)C(=O)NC(C(=O)NC(Cc1ccccc1)C(=O)NC(C(=O)NC(CC(N)=O)C(=O)NC(CO)C(=O)NC(Cc1ccc(O)cc1)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CC(C)C)C(=O)NCC(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CO)C(=O)NC(C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CC(C)C)C(=O)NC(CCC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC(C(=O)NC(CCSC)C(=O)NC(CO)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCC(N)=O)C(=O)NC(CCC(N)=O)C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CO)C(=O)NC(CC(N)=O)C(=O)NC(CCC(N)=O)C(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(C)C(=O)NC(CCCNC(=N)N)C(=O)NC(C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CC(C)C)C(N)=O)C(C)CC)C(C)C)C(C)O)C(C)CC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Tesamorelin 2 mg/day for 6 months
Eligibility criteria:
Inclusion Criteria:

Male or female subjects aged 40-75 years (y) inclusive
Documented diagnosis of moderate to very severe COPD (GOLD stage 2, 3, or 4)
Stable COPD (i.e., no exacerbation) for at least 6 weeks prior to screening
Able to participate in a supervised exercise training program
Evidence of muscle wasting

Exclusion Criteria

Participation in a pulmonary rehabilitation program or in any supervised exercise program during the 4 months prior to screening
More than 4 exacerbations in the year prior to screening
Life-threatening exacerbation in the year prior to screening
Requirement for long-term oxygen therapy (> 12 hours of oxygen per day)
Critical illness or co-morbid conditions that may interfere with study conduct or endpoint measurements
Use of agents known to increase lean body mass within 3 months prior to screening
Hypopituitarism, history of pituitary tumor/surgery, head irradiation, or severe head trauma
Intervention: Egrifta
Trial phase: Phase 2
ATC code: H01AC06
SMILES: CCC=CCC(=O)NC(Cc1ccc(O)cc1)C(=O)NC(C)C(=O)NC(CC(=O)O)C(=O)NC(C)C(=O)NC(C(=O)NC(Cc1ccccc1)C(=O)NC(C(=O)NC(CC(N)=O)C(=O)NC(CO)C(=O)NC(Cc1ccc(O)cc1)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CC(C)C)C(=O)NCC(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CO)C(=O)NC(C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CC(C)C)C(=O)NC(CCC(N)=O)C(=O)NC(CC(=O)O)C(=O)NC(C(=O)NC(CCSC)C(=O)NC(CO)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCC(N)=O)C(=O)NC(CCC(N)=O)C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CO)C(=O)NC(CC(N)=O)C(=O)NC(CCC(N)=O)C(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(C)C(=O)NC(CCCNC(=N)N)C(=O)NC(C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CC(C)C)C(N)=O)C(C)CC)C(C)C)C(C)O)C(C)CC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Tesamorelin 3 mg/day for 6 months
Eligibility criteria:
Inclusion Criteria:

Male or female subjects aged 40-75 years (y) inclusive
Documented diagnosis of moderate to very severe COPD (GOLD stage 2, 3, or 4)
Stable COPD (i.e., no exacerbation) for at least 6 weeks prior to screening
Able to participate in a supervised exercise training program
Evidence of muscle wasting

Exclusion Criteria

Participation in a pulmonary rehabilitation program or in any supervised exercise program during the 4 months prior to screening
More than 4 exacerbations in the year prior to screening
Life-threatening exacerbation in the year prior to screening
Requirement for long-term oxygen therapy (> 12 hours of oxygen per day)
Critical illness or co-morbid conditions that may interfere with study conduct or endpoint measurements
Use of agents known to increase lean body mass within 3 months prior to screening
Hypopituitarism, history of pituitary tumor/surgery, head irradiation, or severe head trauma
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 110
Group description: Continuous infusion of normal saline 2 ml/h for 24 hours

Normal saline
Eligibility criteria:
Inclusion Criteria:

Patients aged 30-70 years American Society of Anesthesiology (ASA) physical status I-III
Scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

Patients with chronic pain and/or on analgesics for the last month,
Patients with central nervous, kidney and liver disease, or allergy to local anesthetics
Intervention: Nitisinone
Trial phase: Phase 2 | Phase 3
ATC code: A16AX04
SMILES: O=C1CCCC(=O)C1C(=O)c1ccc(C(F)(F)F)cc1[N+](=O)[O-]
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: All subjects who participated in treatment received open-label nitisinone, taken orally, supplied as a 2mg tablet.

The starting dose was 2 mg once daily, and increased to 4, 6, and 8 mg/d, case-by-case.
Eligibility criteria:
Inclusion Criteria:

Diagnosis of alkaptonuria with documented increased excretion of homogentisic acid
Willing and able to provide written, signed informed consent, or age appropriate written assent and written informed consent by a legally authorized representative after the study has been explained, prior to any research-related procedures.
Willing and able to be seen in the UCSD Clinical Center for Research or a satellite site for the study visits
Possession of insurance coverage for standard of care procedures, clearly stated in the consent forms

Exclusion Criteria:

Baseline tyrosine level above 250 mmol/mL
Baseline serum creatinine, creatine kinase, or transaminases 2x upper limit of normal
Baseline anemia or thrombocytopenia
Current participation in another investigational medication trial.
Pregnant or lactating women
Current keratopathy, contact use or uncontrolled glaucoma
History myocardial infarction or arrhythmia
History of pulmonary insufficiency
Psychiatric illness that may interfere with compliance or communication
Current malignancy or hypertension
Intervention: Losartan
Trial phase: Not Applicable
ATC code: C09CA01 | C09DA01 | C09DB06
SMILES: CCCCc1nc(Cl)c(CO)n1Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Cozaar: Angiotensin II Receptor Blocker
Eligibility criteria:
Inclusion Criteria:

Adults >age 18 years and < 65 years old
Able to give informed consent
Presence of a bicuspid aortic valve (functional or true bicommisural)and ascending aorta or sinus of Valsalva >4.0cm
No contraindications to treatment with Losartan, an Angiotensin II receptor blocker
Able to safely participate in a 4 week drug washout period if currently taking an angiotensin II receptor blocker or ACE inhibitor.

Exclusion Criteria:

Unable to safely take losartan due to one or more of the following:

Hypersensitivity to losartan or other angiotensin receptor blockers
Pregnancy
Nursing mothers
History of angioedema
Hypotension - chronically volume depleted patients
Hepatic or renal impairment (Cr>1.5mg/dL)
Hyperkalemia (K+>4.8)
Renal artery stenosis
Severe congestive heart failure (class III-IV)
Currently taking potassium supplements or salt substitutes containing potassium
Currently taking lithium
Prior surgical intervention to aorta or aortic valve
Unable or unwilling to give informed consent and follow up with study activities
Currently taking an angiotensin receptor blocker or ACE inhibitor specifically for hypertension and are therefore unable to or are unwilling to participate in a 4 week drug washout period.
Females of child bearing who are unwilling to practice adequate birth control throughout the study.
Intervention: Dinoprostone
Trial phase: Not Applicable
ATC code: G02AD02
SMILES: CCCCC[C@H](O)/C=C/[C@H]1[C@H](O)CC(=O)[C@@H]1C/C=C\CCCC(=O)O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.

Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina.
Eligibility criteria:
Inclusion Criteria:

Single, live fetus
Cephalic (head-first) presentation
Reassuring fetal health assessment
Gestational age between 26 and 42 weeks
Maternal age 18 and above
Bishop score less than 5

Exclusion Criteria:

Multiple Gestation (twins, triplets, quadruplets)
Fetal demise
Fetal malpresentation
Estimated fetal weight less than 500 grams or more than 4000 grams
Placenta previa
Non-reassuring fetal health assessment
Maternal asthma
Latex allergy
Spontaneous labor
Other contraindication to vaginal delivery