anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Travoprost
Trial phase: Phase 2
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: 14
Group description: Travoprost Group A
Eligibility criteria:
Inclusion Criteria:

either sex and any race/ethnicity, ≥18 years old
diagnosed with open-angle glaucoma, and/or ocular hypertension

meets the following IOP entry criteria:

Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1
satisfies all informed consent requirements; able to read, sign and date the informed consent

Exclusion Criteria:

females of childbearing potential not meeting protocol conditions
angle grade less than Grade 2 in either eye
cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
severe central visual field loss in either eye
any abnormality preventing reliable applanation tonometry in either eye
hypersensitivity to prostaglandin analogues or to any component of the study medication
Intervention: Travoprost
Trial phase: Phase 2
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: 13
Group description: Travoprost Group B
Eligibility criteria:
Inclusion Criteria:

either sex and any race/ethnicity, ≥18 years old
diagnosed with open-angle glaucoma, and/or ocular hypertension

meets the following IOP entry criteria:

Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1
satisfies all informed consent requirements; able to read, sign and date the informed consent

Exclusion Criteria:

females of childbearing potential not meeting protocol conditions
angle grade less than Grade 2 in either eye
cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
severe central visual field loss in either eye
any abnormality preventing reliable applanation tonometry in either eye
hypersensitivity to prostaglandin analogues or to any component of the study medication
Intervention: Travoprost
Trial phase: Phase 2
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: 12
Group description: Travoprost Group C
Eligibility criteria:
Inclusion Criteria:

either sex and any race/ethnicity, ≥18 years old
diagnosed with open-angle glaucoma, and/or ocular hypertension

meets the following IOP entry criteria:

Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1
satisfies all informed consent requirements; able to read, sign and date the informed consent

Exclusion Criteria:

females of childbearing potential not meeting protocol conditions
angle grade less than Grade 2 in either eye
cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
severe central visual field loss in either eye
any abnormality preventing reliable applanation tonometry in either eye
hypersensitivity to prostaglandin analogues or to any component of the study medication
Intervention: Misoprostol
Trial phase: Phase 3
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: 678
Group description: MVI 200 mcg vaginal insert

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 pharmacological 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 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, dinoprostone, other prostaglandins or any of the excipients;
Any condition urgently requiring delivery;
Unable to comply with the protocol.
Intervention: Quetiapine Fumarate
Trial phase: Phase 4
SMILES: O=C(O)C=CC(=O)O.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1.OCCOCCN1CCN(C2=Nc3ccccc3Sc3ccccc32)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 32
Group description: Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
Eligibility criteria:
Inclusion Criteria:

Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (1. Bipolar I Disorder, manic or mixed type with/without psychotic feature, 2. Diagnosis should be confirmed by the Mini Inte)
Currently on Lithium/Valproate without antipsychotics more than 3 weeks consecutive treatment YMRS total score ≥16 at study entry

Exclusion Criteria:

Non-response to antipsychotic treatments for manic symptoms in previous episodes
A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria (1. Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%, 2. Admitted to hospital for treatment of DM or DM related illness in past 12 weeks, etc)
An absolute neutrophil count (ANC) of 1.5 x 10^9 per liter
Intervention: 11beta-Hydroxyandrostenedione
Trial phase: Phase 3
SMILES: CC12CC(O)C3C(CCC4=CC(=O)CCC43C)C1CCC2=O
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 107
Group description: Norethisterone 1mg, Ethinyl estradiol 0.02mg

NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg
Eligibility criteria:
Inclusion Criteria:

dysmenorrhea

Exclusion Criteria:

severe hepatopathy
pregnant woman
Intervention: Cyproheptadine Hydrochloride
Trial phase: Phase 3
SMILES: CN1CCC(=C2c3ccccc3C=Cc3ccccc32)CC1.Cl
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.

cyproheptadine hydrochloride: Given orally
Eligibility criteria:
INCLUSION CRITERIA:

≥ 2 years and ≤ 21 years of age at the time of study entry
Scheduled to receive chemotherapy for:
Newly diagnosed:
Non-rhabdo soft tissue sarcomas, scheduled to receive chemotherapy, as well as intermediate or high-risk rhabdomyosarcoma, any stage osteosarcoma and any stage Ewing's sarcoma
Intermediate or high-risk neuroblastoma
Wilms' tumor (Stage III/IV)
Hepatoblastoma (Stage III/IV)
Germ cell tumors (Stage III/IV)
Brain tumors, including medulloblastoma, PNET and ependymomas
AML
Relapsed/recurrent disease (any patient)
Able to register and randomize within 28 days of starting chemotherapy (registration /randomization and start of study agent may occur at anytime up to and including Day 28 after the initiation of chemotherapy)

EXCLUSION CRITERIA:

≥ 29 days after starting chemotherapy
Documented history of unintended weight loss ≥ 5% presumed secondary to cancer within 3 months of study entry
Currently taking cyproheptadine HCl (or have taken cyproheptadine HCl within 3 weeks of study registration)
History of anorexia nervosa or bulimia
Taking other appetite-stimulating medications, i.e. dronabinol (Marinol) during the past three weeks.
Initiation of other appetite enhancing agents, including steroids prescribed for the intent of weight gain, i.e. Megace. Note: Other forms of nutrition therapies, e.g. appetite-stimulating medications, TPN or enteral tube feedings are not allowed during this study.
Children receiving steroids for >7 days as part of their cancer treatment regimen are excluded from participation. However, intermittent steroid use in an antiemetic regimen is allowed during the study
Receiving monoamine oxidase (MAO) inhibitors, procarbazine, fluoxetine (Prozac), or paroxetine (Paxil)
Diagnosed with glaucoma, cystic fibrosis, inflammatory bowel disease, or GI/GU obstruction
Allergy to cyproheptadine HCl
Females of childbearing age must not be pregnant.
Female patients who are lactating must agree to stop breast-feeding.
Intervention: Elocon
Trial phase: Phase 3
ATC code: D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 220
Group description: Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:

5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.
12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks.
Eligibility criteria:
Inclusion Criteria:

Pediatric subjects with perennial allergic rhinitis who satisfy all of the following main criteria:

Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree, after the pretreatment observation period.
Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust-mite antigen).
Male or female outpatients aged 5 to 15 years at the time of providing informed consent.

Exclusion Criteria:

Subjects for whom any of the main exclusion criteria below is applicable will not be registered in this study.

Subjects with coexisting tuberculous disease or lower respiratory tract infection and subjects who have a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment at the time of registration
Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics
Subjects with repeated epistaxis
Subjects who have nasal septum ulcers, nasal surgery, or nasal trauma, which have not healed
Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor
Subjects with complication of vasomotor rhinitis or eosinophilic rhinitis.
Subjects with nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug.
Intervention: Misoprostol
Trial phase: Not Applicable
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: 50
Group description: Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
Eligibility criteria:
Inclusion Criteria:

Participant or surrogate is capable of giving informed consent
Anticipated number - 50 patients with 25 in each study arm Female with singleton gestation, live intrauterine pregnancy
Participant is undergoing an indicated induction of labor
Participant is found to have cervical Bishop score ≤5 on initial cervical exam
Participant has no medical or obstetrical contraindications to induction of labor

Exclusion Criteria:

Participant has ≥2 painful contractions in 10 min in 2 subsequent 10 min periods
Manufacturer's contraindications to misoprostol or oxytocin
Intervention: Asenapine
Trial phase: Phase 3
ATC code: N05AH05
SMILES: CN1CC2c3ccccc3Oc3ccc(Cl)cc3C2C1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 157
Group description: Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
Eligibility criteria:
Inclusion Criteria:

Participant has completed 42-day drug administration in the preceding short-term study (Protocol P06124), has exhibited efficacy (CGI-I at the completion of the preceding short-term study of markedly improved, moderately improved, or slightly improved), has no significant safety problems, and has been judged appropriate for study participation by the investigator.
Male and female participants. Women who are of childbearing potential (i.e., not surgically sterile or post menopausal for at least 1 year) must use medically acceptable birth control. Medically acceptable birth control includes condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, insert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation). Male participants must agree to use condoms during their participation in the study.
Participant must have been explained the nature of the study by the investigator, and be able to provide written consent prior to the conduct of the tests/observation of the clinical study.

Exclusion Criteria:

A participant must not have any clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings that, in the investigator's opinion, preclude the participant's participation in the study
A participant must not have a positive pregnancy test or be planning to become pregnant during the term of the study;
A participant must not receive antipsychotics, antidepressants, mood stabilizers, anti-epileptics, monoamine oxidase inhibitors, St. John's Wort, antiemetics that are dopamine antagonist, or traditional herbal medication for psychiatric symptoms at the baseline;
A participant must not be at risk of harming themselves or others, in the investigator's opinion;
A participant must not have been determined to be unsuitable by an investigator.
Intervention: Minoxidil
Trial phase: Phase 3
ATC code: C02DC01 | D11AX01
SMILES: Nc1cc(N2CCCCC2)nc(N)[n+]1[O-]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 161
Group description: 2% Minoxidil Topical Solution

2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks
Eligibility criteria:
Inclusion Criteria:

females, age 18 or older in general good health
exhibits female pattern hair loss
signs and dates an informed consent document
agrees to use an adequate method of birth control; if of childbearing potential
shows a negative urine pregnancy test at Screening Visit
is willing to maintain the same hair style, hair color, and hair regimen throughout the study
is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures

Exclusion Criteria:

hypersensitivity to the study product, or any ingredients of the study product
known allergy to hair dye, or hair dye components
clinically relevant history of hypotension
untreated or uncontrolled hypertension
pregnant, planning a pregnancy or nursing a child
history of hair transplants
currently use hair weaves or non-breathable wigs
dermatologic disorders of the scalp that require chronic use of medication for control
other types or history of hair loss
enrolled in any other investigational medication (drug) study currently, or within the last 6 months
Intervention: Minoxidil
Trial phase: Phase 3
ATC code: C02DC01 | D11AX01
SMILES: Nc1cc(N2CCCCC2)nc(N)[n+]1[O-]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 161
Group description: 5% Minoxidil Topical Foam

5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks
Eligibility criteria:
Inclusion Criteria:

females, age 18 or older in general good health
exhibits female pattern hair loss
signs and dates an informed consent document
agrees to use an adequate method of birth control; if of childbearing potential
shows a negative urine pregnancy test at Screening Visit
is willing to maintain the same hair style, hair color, and hair regimen throughout the study
is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures

Exclusion Criteria:

hypersensitivity to the study product, or any ingredients of the study product
known allergy to hair dye, or hair dye components
clinically relevant history of hypotension
untreated or uncontrolled hypertension
pregnant, planning a pregnancy or nursing a child
history of hair transplants
currently use hair weaves or non-breathable wigs
dermatologic disorders of the scalp that require chronic use of medication for control
other types or history of hair loss
enrolled in any other investigational medication (drug) study currently, or within the last 6 months
Intervention: Misoprostol
Trial phase: Not Applicable
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
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 78
Group description: Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
Eligibility criteria:
Inclusion Criteria:

18 years
negative pregnancy test
no prior pregnancy beyond 19 6/7 weeks
no pelvic inflammatory disease in last 3 months
no current cervicitis
willing to follow up in 1-2 months

Exclusion Criteria:

active cervical infection
current pregnancy
prior pregnancy beyond 19 6/7 weeks
uterine anomaly
fibroid uterus distorting uterine cavity
copper allergy or wilson's disease for ParaGard
undiagnosed abnormal uterine bleeding
cervical or uterine cancer
sepsis associated with the most recent pregnancy
current breast cancer for levonogestrel IUD
inflammatory bowel disease
allergy to misoprostol
Intervention: Cholini bitartras
Trial phase: Phase 1 | Phase 2
SMILES: C[N+](C)(C)CCO.O=C([O-])C(O)C(O)C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 31
Group description: Choline Bitartrate supplementation

Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.
Eligibility criteria:
Inclusion Criteria:

Available parent or legal guardian capable of participating in informed consent process
Documented history of heavy prenatal alcohol exposure (self-report, social service records, or adoption records) or presence of facial dysmorphology characteristic of FASD or both
Evidence of cognitive deficit in at least one neurocognitive domain

Exclusion Criteria:

History of neurological condition (ex. epilepsy, cerebral palsy, traumatic brain injury)
History of medical condition known to affect brain function
History of other neurodevelopmental disorder (ex. autism, down syndrome)
History of very low birthweight (<1500 grams)
History of prenatal exposure to drugs other than alcohol, nicotine, and caffeine
Intervention: Dexmedetomidine
Trial phase: Phase 3
ATC code: N05CM18
SMILES: Cc1cccc([C@H](C)c2c[nH]cn2)c1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 8
Group description: Dexmedetomidine given as 2mcg/kg bolus over 10 minutes followed by 1.5mcg/kg/hr infusion for duration of scan. The bolus may be repeated up to 2 times at any time during the sedation in the event that adequate sedation conditions (minimum Ramsay Sedation Score of 4) are not achieved. In the event that dexmedetomidine is unable to achieve motionless conditions, after a total of 3 boluses, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg, per established protocol.

Dexmedetomidine: An initial bolus of 2 mcg/kg of dexmedetomidine will be administered over 10 minutes. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a 1.5 mcg/kg/hr infusion is initiated until the MRI is complete.
Eligibility criteria:
Inclusion Criteria:

Patient is 3 - 11 years
Patient is scheduled for MRI at Children's Hospital Boston.
Patient meets criteria to receive either dexmedetomidine or propofol sedation
Patient's guardian provides written consent

Exclusion Criteria:

Patient does not meet established sedation criteria
Patient has history of allergy, intolerance, or reaction to dexmedetomidine or propofol or hypersensitivity
Patient has current, repaired, or risk for Moya-Moya disease
Patient has had a stroke within the past six months
Patient has uncontrolled hypertension
Patient currently uses beta antagonist, alpha 2 agonist or calcium blocker
Known soy, Lecithin, or egg allergy
Intervention: Cycloserine
Trial phase: Phase 2
ATC code: J04AB01
SMILES: N[C@@H]1CONC1=O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 17
Group description: Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.

D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
Eligibility criteria:
Inclusion Criteria:

Certain number of PTSD symptoms plus functional impairment
Must be able to swallow pills

Exclusion Criteria:

Serious kidney or liver disease
Epilepsy
Bipolar
Psychosis
Intervention: Cycloserine
Trial phase: Phase 2
ATC code: J04AB01
SMILES: N[C@@H]1CONC1=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.

D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
Eligibility criteria:
Inclusion Criteria:

Certain number of PTSD symptoms plus functional impairment
Must be able to swallow pills

Exclusion Criteria:

Serious kidney or liver disease
Epilepsy
Bipolar disorder
Psychosis