anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Phenylephrine
Trial phase: Early Phase 1
ATC code: C01CA06 | R01AA04 | R01AB01 | R01BA03 | R01BA53 | S01FB01 | S01FB51 | S01GA05 | S01GA55
SMILES: CNC[C@H](O)c1cccc(O)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: Apply to both nipple/areola regions approximately 1 hour prior to sexual activity

AB-101: Apply approximately 1 hour prior to sexual activity
Eligibility criteria:
Inclusion Criteria:

Female breast cancer survivor
Age: 18 to 70
First diagnosed with Stage I or II breast cancer
Have had breast surgery: nipple sparring mastectomy or lumpectomy
At least 3 years post surgery
Nipple neuropathy post breast surgery (change in Llikeart scale >= 3 between pre and post surgery)
Baseline nipple sensitivity <=5 (likeartLikert scale)
QoL-BC (>=7)
Delayed orgasm (CTCAE v4.0) Grade 2
One of the following: Delayed orgasm (CTCAE v4.0) Grade 2 and/or Vaginal dryness (CTCAE v4.0) Grade 2 or 3
Able to give informed consent
Currently in a monogamous heterosexual relationship for at least 12 months
Sexually active within the last 30 days
Willing to engage in sexual activity at least once a month during the duration of the study
Willing to use on a regular basis a web based form system to record sexual events i.e., have access to the Internet
Willing to use an adequate method of birth control
Able to comply with the study requirements for 8 consecutive weeks
Able to give informed consent

Exclusion Criteria:

Previous adverse event to alpha 1 agonists (oral, nasal, topical, or ocular) or drugs in this class
Currently pregnant
Nursing within the last 6 months prior to beginning the study
History of cardiovascular or cerebrovascular disease, e.g., heart attack, disease of the arteries of the heart, partial heart block, rapid ventricular heartbeat, slow heartbeat, chronic heart failure, severe hardening of the arteries, blood clot in an artery
Actively being treated for breast cancer
Changes in chronic medication for oncology, cardiology, or endocrinology in past 12 months
Uncontrolled or severe hypertension
Decreased oxygen in the tissues or blood
Active inflammation of the liver
Acute inflammation of the pancreas
Overactive thyroid gland
Acidosis
Diabetes
Spinal cord injury
Nipple dermatitis
Regional complex pain syndrome
Use of any hypertensive drugs
Use of MAO inhibitors
Subjects assigned to interventional drug arm and failed to report an increase >=2 from baseline in nipple sensitivity (likert scale) during phase I
In partners: sexual dysfunction or erectile dysfunction
Currently enrolled in any other medical study or has been enrolled in any medical study in the past 30 days
Nipple dermatitis
Regional complex pain syndrome
Unable to provide consent or make allotted clinical visits
Intervention: Atropine
Trial phase: Phase 1 | Phase 2
ATC code: A03BA01 | A03BA03 | A03CB03 | A03CB31 | S01FA01
SMILES: CN1C2CCC1CC(OC(=O)C(CO)c1ccccc1)C2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 31
Group description: 0.01% concentration atropine drops

0.01% concentration atropine drops: One drop of 0.01% concentration atropine in each eye at night for seven days.
Eligibility criteria:
Inclusion Criteria:

-N/A

Exclusion Criteria:

Outside of age range
History of accommodative (focusing) issues or therapy
Intervention: Brexpiprazole
Trial phase: Phase 3
ATC code: N05AX16
SMILES: O=c1ccc2ccc(OCCCCN3CCN(c4cccc5sccc45)CC3)cc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 163
Group description: Participants who received brexpiprazole in a previous double-blind phase 3 study (Trial 331-14-213 {NCT03548584}), received the same dose of brexpiprazole (2 or 3 mg), QD, orally, as they received during the previous study, for up to 12 weeks with dose adjustment.
Eligibility criteria:
Inclusion Criteria:

Participants must have participated in the 331-14-213 study.
Participants must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the participant's symptoms and can observe participant behavior.

Exclusion Criteria:

Participants with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.
Intervention: Brexpiprazole
Trial phase: Phase 3
ATC code: N05AX16
SMILES: O=c1ccc2ccc(OCCCCN3CCN(c4cccc5sccc45)CC3)cc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 96
Group description: Participants who received placebo in a previous double-blind phase 3 study (Trial 331-14-213 {NCT03548584}), received brexpiprazole following a titration schedule, to gradually increase their dose from 0.5 mg QD, in the starting to 2 or 3 mg QD, orally, for up to 12 weeks with dose adjustment.
Eligibility criteria:
Inclusion Criteria:

Participants must have participated in the 331-14-213 study.
Participants must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the participant's symptoms and can observe participant behavior.

Exclusion Criteria:

Participants with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.
Intervention: Lidocaine
Trial phase: Phase 4
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: Accepts Healthy Volunteers
Participants at risk: 233
Group description: This group had lidocaine jelly applied during Mohs surgery

Lidocaine jelly: lidocaine 2% jelly applied during Mohs surgery
Eligibility criteria:
Inclusion criteria:

Patients having Mohs surgery on the nose who are able to consent to the study >18 years old

Exclusion criteria:

unable to consent for themselves known allergy to lidocaine Mohs surgery in locations other than the nose
Intervention: Bupropion
Trial phase: Phase 2
ATC code: A08AA62 | N06AX12
SMILES: CC(NC(C)(C)C)C(=O)c1cccc(Cl)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 48
Group description: Bupropion: Bupropion taken twice daily for 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Currently meets DSM-5 criteria for MDD
Body mass index (BMI) between 18 and 40 kg/m^2, inclusive
Agree to use adequate method of contraception for the duration of the study
Additional criteria may apply

Exclusion Criteria:

Suicide risk
History of treatment resistance in current depressive episode
History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
Additional criteria may apply
Intervention: Nifedipine
Trial phase: Phase 4
ATC code: C07FB03 | C08CA05 | C08CA55 | C08GA01
SMILES: COC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1c1ccccc1[N+](=O)[O-]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Procardia XL 30 mg XL Q 12h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia XL divided in 2 doses of 30 mg given 12h apart.

Procardia XL 30Mg: Procardia XL 30 mg XL Q 12h
Eligibility criteria:
Inclusion Criteria:

Antepartum or postpartum patients between the age of 18-55 requiring 60 mg of Procardia XL to control elevated blood pressures secondary to preeclampsia, gestational hypertension, or chronic hypertension.

Exclusion Criteria:

All patients receiving other antihypertensive medication
All patients with a contraindication to nifedipine: Hypersensitivity to nifedipine or other calcium -channel blocker, cardiogenic shock, concomitant administration with strong CYP34A inducers (rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, St Johns Wort) → significantly reduces nifedipine efficacy, impaired liver function→? Patients with hepatic impairment (liver cirrhosis) have a longer disposition half-life and higher bioavailability of nifedipine than healthy volunteers
Patients over the age of 55
Intervention: Nifedipine
Trial phase: Phase 4
ATC code: C07FB03 | C08CA05 | C08CA55 | C08GA01
SMILES: COC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1c1ccccc1[N+](=O)[O-]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Procardia XL 60 mg Q 24h - When a patient's BP is persistently elevated after a dose of 30 mg of Procardia XL, the dose is increased to 60 mg Procardia given once a day.

Procardia XL 60Mg: Procardia XL 60 mg Q 24h
Eligibility criteria:
Inclusion Criteria:

Antepartum or postpartum patients between the age of 18-55 requiring 60 mg of Procardia XL to control elevated blood pressures secondary to preeclampsia, gestational hypertension, or chronic hypertension.

Exclusion Criteria:

All patients receiving other antihypertensive medication
All patients with a contraindication to nifedipine: Hypersensitivity to nifedipine or other calcium -channel blocker, cardiogenic shock, concomitant administration with strong CYP34A inducers (rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, St Johns Wort) → significantly reduces nifedipine efficacy, impaired liver function→? Patients with hepatic impairment (liver cirrhosis) have a longer disposition half-life and higher bioavailability of nifedipine than healthy volunteers
Patients over the age of 55
Intervention: Semaglutide
Trial phase: Phase 4
ATC code: A10BJ06
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCCCNC(=O)COCCOCCNC(=O)COCCOCCNC(=O)CC[C@@H](NC(=O)CCCCCCCCCCCCCCCCC(=O)O)C(=O)O)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(N)=O)NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)C(C)(C)NC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](C)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](C(=O)N[C@@H](CCCNC(=N)N)C(=O)NCC(=O)N[C@@H](CCCNC(=N)N)C(=O)NCC(=O)O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 634
Group description: Participants received semaglutide subcutaneous (s.c.) injection once weekly in addition to up to 2 oral antidiabetic medications as treatment intensification for 1 year. Medication dose and dose escalation was at the discretion of the study physician according to routine practice for medications for glycemic control in participants.
Eligibility criteria:
Inclusion Criteria:-

Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study.
Male or female, age 18 years or older at the time of signing informed consent.
Type 2 diabetes mellitus diagnosis.
Treatment with either 1 or 2 oral antidiabetic medications.
Current member of a commercial or Medicare health plan with pharmacy benefits.
Recorded HbAlc value within the last 90 days prior to randomization.
Further intensification with an additional antidiabetic oral or injectable medication is indicated to achieve glycemic target at the discretion of the study physician according to approved labelling.

Exclusion Criteria:

Previous randomization in this study
Treatment with more than 2 oral antidiabetic medications, oral semaglutide, or any injectable medication in a period of 30 days before the day of eligibility assessment. Temporary/emergency use of any type of insulin is allowed, as is prior insulin treatment for gestational diabetes.
Contraindications to semaglutide according to the Food and Drug Administration approved label.
Female who is pregnant, breastfeeding or intends to become pregnant
Participation in another clinical trial.
Intervention: ELINZANETANT
Trial phase: Phase 2
SMILES: Cc1cc(F)ccc1-c1cc(N2C[C@H]3COCCN3C[C@H]2CO)ncc1N(C)C(=O)C(C)(C)c1cc(C(F)(F)F)cc(C(F)(F)F)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.
Eligibility criteria:
Key Inclusion Criteria:

Postmenopausal
Body mass index between 18 and 38 kg/m2, inclusive
Subject experiences moderate or severe hot flashes

Key Exclusion Criteria:

Inability to comply with the use of prohibited and allowed medications as described in the protocol.
Any prior or ongoing history of clinically relevant drug or alcohol abuse within 12 months of Screening.
Any clinically significant prior or ongoing history of arrhythmias, either determined through clinical history or on ECG evaluation.
Any clinically significant abnormal laboratory test result(s) measured at Screening.
Any active ongoing condition that could have caused difficulty in interpreting vasomotor symptoms.
Uncontrolled hypertension.
A history or hyperthyroidism, hypothyroidism or abnormal thyroid function tests at Screening. Treated hypothyroidism with normal thyroid function test results at Screening is acceptable.
Intervention: ELINZANETANT
Trial phase: Phase 2
SMILES: Cc1cc(F)ccc1-c1cc(N2C[C@H]3COCCN3C[C@H]2CO)ncc1N(C)C(=O)C(C)(C)c1cc(C(F)(F)F)cc(C(F)(F)F)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.
Eligibility criteria:
Key Inclusion Criteria:

Postmenopausal
Body mass index between 18 and 38 kg/m2, inclusive
Subject experiences moderate or severe hot flashes

Key Exclusion Criteria:

Inability to comply with the use of prohibited and allowed medications as described in the protocol.
Any prior or ongoing history of clinically relevant drug or alcohol abuse within 12 months of Screening.
Any clinically significant prior or ongoing history of arrhythmias, either determined through clinical history or on ECG evaluation.
Any clinically significant abnormal laboratory test result(s) measured at Screening.
Any active ongoing condition that could have caused difficulty in interpreting vasomotor symptoms.
Uncontrolled hypertension.
A history or hyperthyroidism, hypothyroidism or abnormal thyroid function tests at Screening. Treated hypothyroidism with normal thyroid function test results at Screening is acceptable.
Intervention: ELINZANETANT
Trial phase: Phase 2
SMILES: Cc1cc(F)ccc1-c1cc(N2C[C@H]3COCCN3C[C@H]2CO)ncc1N(C)C(=O)C(C)(C)c1cc(C(F)(F)F)cc(C(F)(F)F)c1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: Participants received 4x40 mg elinzanetant capsules.
Eligibility criteria:
Key Inclusion Criteria:

Postmenopausal
Body mass index between 18 and 38 kg/m2, inclusive
Subject experiences moderate or severe hot flashes

Key Exclusion Criteria:

Inability to comply with the use of prohibited and allowed medications as described in the protocol.
Any prior or ongoing history of clinically relevant drug or alcohol abuse within 12 months of Screening.
Any clinically significant prior or ongoing history of arrhythmias, either determined through clinical history or on ECG evaluation.
Any clinically significant abnormal laboratory test result(s) measured at Screening.
Any active ongoing condition that could have caused difficulty in interpreting vasomotor symptoms.
Uncontrolled hypertension.
A history or hyperthyroidism, hypothyroidism or abnormal thyroid function tests at Screening. Treated hypothyroidism with normal thyroid function test results at Screening is acceptable.
Intervention: Cyclosporine
Trial phase: Phase 2
ATC code: L04AD01 | S01XA18
SMILES: CC=CCC(C)C(O)C1C(=O)NC(CC)C(=O)N(C)CC(=O)N(C)C(CC(C)C)C(=O)NC(C(C)C)C(=O)N(C)C(CC(C)C)C(=O)NC(C)C(=O)NC(C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(CC(C)C)C(=O)N(C)C(C(C)C)C(=O)N1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: 0.05% cyclosporine ophthalmic emulsion (Restasis®) BID, both eyes for 28 days

Restasis®: Comparator
Eligibility criteria:
Inclusion Criteria:

Have a best corrected visual acuity (BCVA) in both eyes of +0.7 logarithm of the Minimum Angle of Resolution (logMAR) or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.
Have a documented history of DED in both eyes supported by a previous clinical diagnosis.

Have ongoing DED, as defined by at least one eye (if one eye, the same eye) meeting all the following criteria:

A symptom severity score of ≥30 for Eye Dryness on a Visual Analog Scale (VAS) (0-100)
An unanesthetized Schirmer Tear Test (STT) score of ≥1 mm and ≤10 mm per 5 minutes (Note: STT Score obtained at Visit 1)
Evidence of ocular surface staining (total fluorescein staining score of at least 3 [0-15 scale]).
Have normal lid anatomy.

Exclusion Criteria:

Have any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes.
Be unable to demonstrate correct instillation of over-the-counter (OTC) ocular lubricant.
Report discomfort in both eyes from instillation of OTC ocular lubricant during Visit 2 (based on score of ≥30 on the Drop Discomfort VAS).
Have used Restasis® (cyclosporine ophthalmic emulsion) within 30 days prior to Visit 1.
Have used Restasis® for more than 1 month (if prior use is reported).
Have used Xiidra® (lifitegrast ophthalmic solution) within 14 days prior to Visit 1.
Have had corneal graft surgery in either eye within 1 year.
Have recent or current evidence of ocular infection or inflammation in either eye.
Have current evidence of clinically significant blepharitis (defined as requiring lid hygiene therapy), conjunctivitis, or a history of herpes simplex or zoster keratitis in either eye.
Intervention: Molindone
Trial phase: Phase 3
ATC code: N05AE02
SMILES: CCc1c(C)[nH]c2c1C(=O)C(CN1CCOCC1)CC2
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 21
Group description: Subjects treated with flexible dose of SPN-810 (36, 45 or 54 mg/day)
Eligibility criteria:
Inclusion Criteria:

Otherwise, healthy non-smoking, male and females adolescents (12-17 years of age at the time of screening) with a primary diagnosis of ADHD and currently taking an optimized FDA-approved ADHD medication.
IA confirmed at screening using R-MOAS scale and Vitiello Aggression Questionnaire.

Exclusion Criteria:

History or current diagnosis of epilepsy, major depressive disorder, bipolar disorder, schizophrenia and other psychotic disorders, personality disorder, Tourette's syndrome or dissociative disorder, autism spectrum disorder, pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or intermittent explosive disorder.
Currently meeting DSM-5 criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder or intermittent explosive disorder.
Known or suspected intelligence quotient (IQ) <70, active suicidal plan/intent or active suicidal thought, criminal arrest, alcohol or drug use or pregnancy.
Intervention: Melatonin
Trial phase: Phase 2
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 19
Group description: melatonin 2mg (equal to or over 40kg)

melatonin 1mg (under 40kg)

Melatonin: melatonin
Eligibility criteria:
Inclusion Criteria:

Meet ICHD criteria for episodic migraine in children and adolescents, with at least 1 migraine attack per month on average.
Age 3-17 years
Dissatisfaction with previous acute treatments, for one or more of the following reasons: a) One or more previously tried acute medications have not been effective, or adequately effective, b) previously tried acute treatments have caused side effects, or C) patient/family would prefer a natural supplement for acute treatment over medication treatment
If of driving age, teen participant agrees not to drive for at least 8 hours after treating with melatonin.

Exclusion Criteria:

Allergy or intolerance to melatonin, or to chocolate.
Opioid or barbiturate overuse as defined in ICHD
Pregnant/lactating
Intervention: Melatonin
Trial phase: Phase 2
ATC code: N05CH01
SMILES: COc1ccc2[nH]cc(CCNC(C)=O)c2c1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 21
Group description: melatonin 8mg (equal to or over 40kg)

melatonin 4mg (under 40kg)

Melatonin: melatonin
Eligibility criteria:
Inclusion Criteria:

Meet ICHD criteria for episodic migraine in children and adolescents, with at least 1 migraine attack per month on average.
Age 3-17 years
Dissatisfaction with previous acute treatments, for one or more of the following reasons: a) One or more previously tried acute medications have not been effective, or adequately effective, b) previously tried acute treatments have caused side effects, or C) patient/family would prefer a natural supplement for acute treatment over medication treatment
If of driving age, teen participant agrees not to drive for at least 8 hours after treating with melatonin.

Exclusion Criteria:

Allergy or intolerance to melatonin, or to chocolate.
Opioid or barbiturate overuse as defined in ICHD
Pregnant/lactating
Intervention: Guadecitabine
Trial phase: Phase 2
SMILES: Nc1ncn([C@H]2C[C@H](OP(=O)(O)OC[C@H]3O[C@@H](n4cnc5c(=O)[nH]c(N)nc54)C[C@@H]3O)[C@@H](CO)O2)c(=O)n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Participants received guadecitabine, SC injection on Days 1-5 of each 28-day cycle, up to at the same dose that they were receiving in the last cycle of their prior study or at a different dose as guided by the dose adjustment guidelines in the prior study protocol up to a maximum of 26 cycles.
Eligibility criteria:
Inclusion Criteria:

Previous participation in an Astex-sponsored guadecitabine clinical trial [including but not limited to SGI-110-01 (NCT01261312), SGI-110-04 (NCT03603964), SGI-110-05, SGI-110-06 (NCT02920008), and SGI-110-07 (NCT02907359)], in which the participant was treated with guadecitabine and was still on active treatment with guadecitabine at the time of database close for the prior study.
Participant is considered to be benefitting from guadecitabine treatment in the opinion of the treating investigator.
Able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent before any study-specific procedure.
Women of child-bearing potential (according to recommendations of the Clinical Trial Facilitation Group [CTFG]) must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential and men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures while receiving treatment with guadecitabine and for at least 3 months after completing treatment and must agree not to become pregnant or father a child while receiving study treatment and for at least 3 months after completing guadecitabine treatment.

Exclusion Criteria:

1. Any participant who, in the opinion of the investigator, may have other conditions, organ dysfunction, or have safety data from their prior study participation that suggest that the risks of continuing treatment with guadecitabine may outweigh the benefits.