anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Co-codamol
Trial phase: Phase 4
SMILES: CC(=O)Nc1ccc(O)cc1.COc1ccc2c3c1OC1C(O)C=CC4C(C2)N(C)CCC341.O=P(O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 416
Group description: Codeine/acetaminophen (30 mg/300 mg)

Codeine/acetaminophen
Eligibility criteria:
Inclusion Criteria:

Complaint of acute pain of < 7 days duration
Location of pain in one or more extremities defined as distal to and including the shoulder joint in the upper extremities and distal to and including the hip joint in the lower extremities;
Radiologic evaluation is planned

Exclusion Criteria:

Inability to confirm reliable means of phone followup.
Past use of methadone
Chronic condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or any neuropathy
History of an adverse reaction to any of the study medications
Opioids taken in the past 24 hours
Ibuprofen or acetaminophen taken in past 8 hours
Pregnancy by either urine or serum HCG testing
Breastfeeding per patient report
History of peptic ulcer disease
Report of any prior use of recreational narcotics
Medical condition that might affect metabolism of opioid analgesics, acetaminophen, or ibuprofen such as hepatitis, renal insufficiency, hypo- or hyperthyroidism, Addison's or Cushing's disease
Taking any medicine that might interact with one of the study medications, such as antidepressant SSRI's or Tricyclics, antipsychotics, anti-malaria medications quinidine or halofantrine, Amiodarone or Dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine, or St John's Wort.
Intervention: Ataluren
Trial phase: Phase 3
ATC code: M09AX03
SMILES: O=C(O)c1cccc(-c2noc(-c3ccccc3F)n2)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 245
Group description: Participants were administered ataluren orally at a dose of 10 mg/kg in the morning, 10 mg/kg at midday, and 20 mg/kg in the evening for up to 96 weeks.
Eligibility criteria:
Inclusion Criteria:

Completion of study treatment (placebo or active) in the previous Phase 3, double-blind study protocol (Protocol PTC124-GD-021-CF)
Evidence of signed and dated informed consent/assent document(s) indicating that the participant (and/or the participant's parent/legal guardian) has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

Known hypersensitivity to any of the ingredients or excipients of the study drug.
Ongoing participation in any other therapeutic clinical trial.
Intervention: Zopiclone
Trial phase: Phase 4
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 41
Group description: Intervention: Six months of eszopiclone 3 mg nightly use

Eszopiclone
Eligibility criteria:
Inclusion Criteria:

DSM-5 diagnosis of insomnia

Exclusion Criteria:

acute or unstable medical disease,
current or past history of psychiatric disease, alcoholism or drug abuse, and other primary sleep disorders
Intervention: Ondansetron
Trial phase: Not Applicable
ATC code: A04AA01
SMILES: Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 319
Group description: 160 Patients will randomly be assigned, using sealed numbered opaque envelopes to receive 8mg ondansetron tablet 30 minutes prior to taking 200mg PO doxycycline

Ondansetron: 8mg PO ondansetron 30 minutes prior to 200mg PO doxycycline
Eligibility criteria:
Inclusion Criteria:

Pregnant women seeking care at the University of Rochester's Women's Health Practice Family Planning Clinic
Undergoing second trimester surgical termination of pregnancy
Proficient in reading, writing, and comprehending English
Able to give informed consent

Exclusion Criteria:

Not proficient in reading, writing, or comprehending English
Not able to give informed consent
Already taking antiemetics
Doxycycline allergy
Hyperemesis gravidarum
History of gastroparesis or cyclical vomiting
Unable to swallow pills
Intervention: Oxcarbazepine
Trial phase: Phase 4
ATC code: N03AF02
SMILES: NC(=O)N1c2ccccc2CC(=O)c2ccccc21
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 50
Group description: Twenty five (25) patients of bipolar mania will be prescribed oxcarbazepine for 4 weeks.

Oxcarbazepine: After baseline assessments, patients in test group will be prescribed Tab. Oxcarbazepine (600mg/daily in two divided dose for 1 week followed by 900mg/daily in two divided dose for next 3 weeks).
Eligibility criteria:
Inclusion Criteria:

All patients with the diagnosis of bipolar affective disorder (by ICD-10 DCR) current episode mania without psychotic symptoms
Patients aged 18-45 years, of either sex.
Patients with baseline score > 20 on the Young Mania Rating Scale (YMRS).
Patients who had not taken any treatment for at least 4 weeks before inclusion.

Exclusion Criteria:

Patients with bipolar disorder (by ICD-10 DCR) presenting during depressive/euthymic/mixed episode.
Patients who are already under treatment for the presenting conditions.
Rapid cycling in the past 12 months.
Previous history of refractoriness to carbazepine or oxcarbazepine.
Patients with comorbid substance abuse or history of organicity
Pregnant and nursing women, patients with history of major medical or neurological illness.
Intervention: Granisetron
Trial phase: Phase 2
ATC code: A04AA02
SMILES: CN1C2CCCC1CC(NC(=O)c1nn(C)c3ccccc13)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: Preoperative administration of granisetron transdemal patch

granisetron: Application granisetron transdermal patch preoperatively
Eligibility criteria:
Inclusion Criteria:

Patients that are between the ages of 18 and 89
Scheduled to undergo surgical procedures with general anesthesia
Seen in the anesthesia clinic at least 24 hours before surgery
History of severe PONV after previous general anesthesia
Surgical procedures with anticipated duration > 1 hour and no more than 5 hours
American Society of Anesthesiologists (ASA) physical status I to III

Exclusion Criteria:

Allergy to granisetron or other 5HT3RA drugs
Previous allergic reactions to any drug skin patches
Recent (less than 1 month) or current chemo- or radiotherapy
Any nausea, vomiting, or retching within 24 hours prior to anesthesia
Any type of eye surgeries
History or diagnosis of gastrointestinal obstruction or ileus
History of serotonin syndrome
Unable to sign consent
Intervention: Ledipasvir
Trial phase: Phase 2
ATC code: J05AP51
SMILES: COC(=O)N[C@H](C(=O)N1CC2(CC2)C[C@H]1c1nc(-c2ccc3c(c2)C(F)(F)c2cc(-c4ccc5[nH]c([C@@H]6[C@H]7CC[C@H](C7)N6C(=O)[C@@H](NC(=O)OC)C(C)C)nc5c4)ccc2-3)c[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
Eligibility criteria:
Key Inclusion Criteria:

Acute, untreated, hepatitis C infection, genotype 1 or 4, with an estimated duration less than 24 weeks
Confirmed HIV-1 infection
CD4 T cell count >200/μL for individuals receiving antiretroviral therapy (ART), CD4 T cell count > 500/μL at screening for individuals without ART
Use of two effective contraception methods if female of childbearing potential or sexually active male with female partner

Key Exclusion Criteria:

Pregnant or nursing female or male with pregnant female partner
Chronic liver disease of a non HCV etiology
Coinfection with hepatitis B virus (HBV)
Treatment with any investigational drug or device within 60 days of the screening visit.
History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Intervention: Dasotraline
Trial phase: Phase 3
SMILES: N[C@@H]1CC[C@@H](c2ccc(Cl)c(Cl)c2)c2ccccc21
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 236
Group description: Dasotraline 2, 4, 6 mg, flexibly dosed
Eligibility criteria:
Inclusion Criteria:

At least one of the subject's parent/legal guardian must give written informed consent, including privacy authorization, prior to study participation. The subject will complete an informed assent prior to study participation.
Subject and subject's parent/legal guardian are judged by the investigator to be willing and able to comply with the study procedures and visit schedules.
Subject has completed all required assessments for Week 6 of the core study.
Subject has not taken any medication other than the study drug for the purpose of controlling ADHD symptoms during the core study.
Subject, if female, must not be pregnant or breastfeeding.
Female subject: must be unable to become pregnant (eg, premenarchal, surgically sterile, etc);

-OR-

practice true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent/assent to at least 14 days after the last dose of study drug has been taken; -OR-
is sexually active and willing to use a medically effective method of birth control from signing informed consent/assent to at least 14 days after the last dose of study drug has been taken.
Male subject must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control, from signing informed consent/assent to at least 14 days after the last dose of study drug has been taken.
Any subject whose weight is less than or equal to 21 kg at the OL Baseline visit should be discussed with the medical monitor prior to enrollment.
Subject and subject's parent/legal guardian must be able to fully comprehend the informed consent/assent form (as applicable), understand all study procedures, and be able to communicate satisfactorily with the Investigator and study coordinator.

Exclusion Criteria:

-Subject is considered by the investigator to be at imminent risk of suicide, injury to self or to others, or damage to property.
Subject answers "yes" to "Suicidal Ideation" item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) for any lifetime history on the C SSRS Children's "Since Last Visit" assessment at OL Baseline.
Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory tests that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
Subject has a positive urine drug screen (UDS) or breath alcohol test at OL Baseline.
Subject or parents/legal guardian has commitments during the study that would interfere with attending study visits.
Subject is at high risk of non-compliance in the investigator's opinion.
Intervention: Liothyronine
Trial phase: Phase 2
ATC code: H03AA02 | H03AA03
SMILES: NC(Cc1cc(I)c(Oc2ccc(O)c(I)c2)c(I)c1)C(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Liothyronine: Oral supplement given every 8 hours
Eligibility criteria:
2 WEEKS STUDY:

INCLUSION CRITERIA:

1. Mutation of the insulin receptor (either recessive or dominant negative). If mutation status is not known prior to enrollment, subjects will undergo genotyping at enrollment. In the unanticipated event that a patient does not have a mutation of the insulin receptor, he or she will not complete the study and his or her data will not be included in the analysis.

EXCLUSION CRITERIA:

Changes in doses of diabetes medications (including metformin, insulin, sulfonylureas, thiazolidinediones, leptin, GLP-1 agonists, DPP4 inhibitors, etc.) in the preceding 10 weeks.
Any medical condition or medication that will increase risk to the subject (e.g. ischemic or structural heart disease, congestive heart failure, uncontrolled hypertension, or arrhythmia) or that will interfere with interpretation of study data.
Disorders that would lead to erratic gastrointestinal absorption or loss of thyroid hormone from the gut (severe diarrhea, celiac disease, use of bile acid sequestrants, excessive consumption of soybean products).
Any form of endogenous hyperthyroidism or hypothyroidism at baseline.
Current or recent (past 8 weeks) use of thyroid hormone or anti-thyroid drugs.
Extreme disorders of thyroid hormone binding to thyroid binding globulin (excess or deficiency) or protein loss (nephrotic range proteinuria) that would lead to difficulties achieving a consistent thyroid hormone level for study.
Known presence of a rare clinical disorder that leads to thyroid hormone insensitivity (known T3 receptor mutations, selenocysteine insertion sequence-binding protein 2 (SBP2) abnormalities, monocarboxylate transporter defects).
Current use of beta blockers
Pregnancy or breast feeding
Any EKG abnormality that could increase risk of T3 treatment (resting sinus tachycardia (age adjusted norms), atrial fibrillation, myocardial ischemia, left or right ventricular excitation block, left ventricular hypertrophy or extrasystoles)
Known allergy or hypersensitivity to any form of thyroid hormone
Known adrenal insufficiency
Dependence on oral anticoagulant medications (adults only)
Use of tricyclic anti-depressants, as transient cardiac arrhythmias have been observed with the concomitant use of thyroid hormone.
Use of cholestyramine.
History of clinically significant osteoporosis per investigator judgment (e.g. previous fragility fracture)

6 MONTHS STUDY:

Patients must meet all inclusion and exclusion criteria for the short-term study, plus have poorly controlled diabetes, defined as a hemoglobin A1c greater than or equal to 7%.
Intervention: Buspirone
Trial phase: Phase 2
ATC code: N05BE01
SMILES: O=C1CC2(CCCC2)CC(=O)N1CCCCN1CCN(c2ncccn2)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: This drug will be taken for two week period

Buspirone: The initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached.
Eligibility criteria:
Inclusion Criteria:

Adults with SCI (>6months after spinal cord injury) at the T6 level/above

Exclusion Criteria:

Pregnant and lactating females
Heart failure, vascular disease, or stroke
Advanced chronic obstructive pulmonary disease (COPD), liver disease, and chronic kidney disease
BMI >38 kg/m2
Mechanical ventilation dependence

The following medications are not allowed (potential interaction with buspirone or inhibition of the CYP3A4 system):

cimetidine
ketoconazole
ritonavir
itraconazole
erythromycin
diltiazem
verapamil
Monoamine oxidase (MAO) inhibitors [such as Marplan, Nardil, Parmate, Emsam]
Other prohibited concomitant medications include haloperidol, trazodone, or triazolam
Intervention: Trazodone
Trial phase: Phase 2
ATC code: N06AX05
SMILES: O=c1n(CCCN2CCN(c3cccc(Cl)c3)CC2)nc2ccccn12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 9
Group description: This drug will be taken for two week period

Trazodone: 100 mg dose before bed-time
Eligibility criteria:
Inclusion Criteria:

Adults with SCI (>6months after spinal cord injury) at the T6 level/above

Exclusion Criteria:

Pregnant and lactating females
Heart failure, vascular disease, or stroke
Advanced chronic obstructive pulmonary disease (COPD), liver disease, and chronic kidney disease
BMI >38 kg/m2
Mechanical ventilation dependence

The following medications are not allowed (potential interaction with buspirone or inhibition of the CYP3A4 system):

cimetidine
ketoconazole
ritonavir
itraconazole
erythromycin
diltiazem
verapamil
Monoamine oxidase (MAO) inhibitors [such as Marplan, Nardil, Parmate, Emsam]
Other prohibited concomitant medications include haloperidol, trazodone, or triazolam
Intervention: Revefenacin
Trial phase: Phase 3
ATC code: R03BB08
SMILES: CN(CCN1CCC(OC(=O)Nc2ccccc2-c2ccccc2)CC1)C(=O)c1ccc(CN2CCC(C(N)=O)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 212
Group description: 88 mcg

TD-4208
Eligibility criteria:
Inclusion Criteria:

Subject is a male or female subject 40 years of age or older

Exclusion Criteria:

Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study
Intervention: Revefenacin
Trial phase: Phase 3
ATC code: R03BB08
SMILES: CN(CCN1CCC(OC(=O)Nc2ccccc2-c2ccccc2)CC1)C(=O)c1ccc(CN2CCC(C(N)=O)CC2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 198
Group description: 175 mcg

TD-4208
Eligibility criteria:
Inclusion Criteria:

Subject is a male or female subject 40 years of age or older

Exclusion Criteria:

Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study
Intervention: Sotagliflozin
Trial phase: Phase 2
ATC code: A10BK06
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](SC)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Sotagliflozin 400 mg (two 200 mg tablets), once daily, orally, for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Participant had given written informed consent to participate in the study in accordance with local regulations.
Adult participants 18 years and older with a diagnosis of type 1 diabetes mellitus (T1D) made at least 1 year prior to informed consent.
Participants were being treated with insulin or insulin analog delivered via continuous subcutaneous insulin infusion (CSII) or multiple daily injection (MDI).
At the Screening Visit, A1C had to be between 7.0% and 10.0%.
Females of childbearing potential had to use an adequate method of contraception and have a negative pregnancy test.

Exclusion Criteria:

Use of antidiabetic agent other than insulin or insulin analog at the time of screening.
Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening.
Chronic systemic corticosteroid use.
Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator.
Intervention: Cholecalciferol
Trial phase: Phase 4
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 93
Group description: Women allocated to vitamin D3 group received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.

Vitamin D3: Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
Eligibility criteria:
Inclusion Criteria:

Women with PCOS who have vitamin D deficiency (serum 25-hydroxyvitamin D<20 ng/mL)

Exclusion Criteria:

Pregnant, postpartum, breast feeding
Taking Metformin, vitamin D, or any hormonal therapy
Intervention: Ponesimod
Trial phase: Phase 2
ATC code: L04AA50
SMILES: CCC/N=C1\S/C(=C\c2ccc(OC[C@H](O)CO)c(Cl)c2)C(=O)N1c1ccccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: It was planned that enrolled subjects receive ponesimod in escalating doses of 5, 10 and 20 mg over the course of the treatment period of 24 weeks in total (4 weeks of 5 mg incl. up-titration, 4 weeks of 10 mg incl. up-titration and 16 weeks of 20 mg).
Eligibility criteria:
Inclusion Criteria:

Signed informed consent
Symptomatic moderate or severe chronic GVHD patients in need of a change of systemic immunosuppressant (IS) therapy
Women of child bearing potential must have a negative pregnancy test and use reliable methods of contraception

Exclusion Criteria:

Clinically significant medical conditions including active or uncontrolled infections, new or recurrent malignancy, serious cardiac, pulmonary, or renal disease, and uncontrolled diabetes.
Karnofsky Performance Score < 60.
Immunosuppressant therapies other than allowed background therapy
Anti-arrhythmic and heart rate lowering drugs.
Any other circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Intervention: Caffeine
Trial phase: Not Applicable
ATC code: D11AX26 | N06BC01 | R03DA20 | V04CG30
SMILES: Cn1c(=O)c2c(ncn2C)n(C)c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 205
Group description: One-time treatment with 200mg caffeine pill

Caffeine: 200mg delivered as pill; one-time dose
Eligibility criteria:
Inclusion Criteria:

18 years-old or older
available to participate on the dates specified
willing to take a caffeine or placebo pills at study session
willingness to abstain from caffeine for 12 hours prior to study visit (8:30pm-8:30am)
UAB employees or students with some college education (including current enrollment)

Exclusion Criteria:

self-reported use of ADHD medication
self-reported use of anxiety medication
self-reported use of sleep medication
self-reported use of nicotine products
self-reported lactose intolerance
self-reported uncorrected vision
self-reported pregnancy or trying to become pregnant
Intervention: Ethanol
Trial phase: Phase 3
ATC code: D08AX08 | V03AB16 | V03AZ01
SMILES: CCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 133
Group description: Lotion

IDP-118 Lotion: Lotion
Eligibility criteria:
Key Inclusion Criteria:

Male or female, of any race, at least 18 years of age (inclusive).
Freely provides both verbal and written informed consent.
Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this calculation.
Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment).

Key Exclusion Criteria:

Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.
Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
Is pregnant, nursing an infant, or planning a pregnancy during the study period.
Has received treatment with any investigational drug or device within 60 days or 5 drug half lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.