anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ketamine
Trial phase: Phase 4
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours

Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion
Eligibility criteria:
Inclusion Criteria:

All adult patients (18 years and above) who are undergoing either thoracotomy or video assisted thoracic surgery (VATS).
Participants must be able to understand English.

Exclusion Criteria:

Patient refusal
History of previous chronic thoracic pain
Neuropathic pain (whatever the site), existing at time of recruitment
Pre-operative analgesic treatments which include the following medications: strong opioids (step 3 analgesics), tricyclic antidepressants, venlafaxine, gabapentin, pregabalin, duloxetine, clonazepam or carbamazepine.
Allergy to bupivacaine, morphine, paracetamol, tramadol, dihydrocodeine or ketamine.
Intervention: Moxifloxacin Hydrochloride
Trial phase: Phase 4
SMILES: COc1c(N2CC3CCCNC3C2)c(F)cc2c(=O)c(C(=O)O)cn(C3CC3)c12.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
Eligibility criteria:
Inclusion Criteria:

Man or woman 18 years of age or older.
Physically capable of instilling eye drop or have an appropriate person available to assist in administration of eye drops 4 times a day.
Scheduled for phacoemulsification with intraocular lens (IOL) implantation for the treatment of cataract.
Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and be medically cleared for surgery.
Willing to adhere to the prohibitions and restrictions specified in this protocol.
Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

Known allergy or contraindication to the test article(s) or their components.
Presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters.
Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.
History of any significant illness that could be expected to interfere with the study parameters. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.

Use of disallowed therapies (systemic or topical):

Fluoroquinolone anti-infective agents (systemic or topical) within 1 week of Visit 1 or anytime after Visit 1 for the duration of the study.
Use of contact lenses for one week prior to the study and for the duration of the study.
Received an experimental drug or used an experimental medical device within 21 days before the planned start of treatment.
Intervention: Besifloxacin
Trial phase: Phase 4
ATC code: S01AE08
SMILES: N[C@@H]1CCCCN(c2c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c2Cl)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 60
Group description: Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
Eligibility criteria:
Inclusion Criteria:

Man or woman 18 years of age or older.
Physically capable of instilling eye drop or have an appropriate person available to assist in administration of eye drops 4 times a day.
Scheduled for phacoemulsification with intraocular lens (IOL) implantation for the treatment of cataract.
Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and be medically cleared for surgery.
Willing to adhere to the prohibitions and restrictions specified in this protocol.
Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

Known allergy or contraindication to the test article(s) or their components.
Presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters.
Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection.
History of any significant illness that could be expected to interfere with the study parameters. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.

Use of disallowed therapies (systemic or topical):

Fluoroquinolone anti-infective agents (systemic or topical) within 1 week of Visit 1 or anytime after Visit 1 for the duration of the study.
Use of contact lenses for one week prior to the study and for the duration of the study.
Received an experimental drug or used an experimental medical device within 21 days before the planned start of treatment.
Intervention: Naltrexone
Trial phase: Phase 2
ATC code: A08AA62 | N02AA56 | N07BB04
SMILES: [H][C@@]12Oc3c(O)ccc4c3[C@@]13CCN(CC1CC1)[C@]([H])(C4)[C@]3(O)CCC2=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: 50 mg of naltrexone orally daily.
Eligibility criteria:
Inclusion Criteria:

Men and women between the ages of 18 and 65 meeting DSM-IV criteria for current alcohol dependence.
More than 14 drinks (women) or 21 drinks (men) per week including at least 2 heavy drinking days/week on average (men > 5 drinks/day; women > 4 drinks/day) during a consecutive 30-day period within the 90 days prior to screening.
Ability to understand and sign written informed consent.
Must have a 0.0 gms/dL breathalyzer reading on the day of screening and 0.0 gms/dL on the day of randomization.
Must be willing to refrain from drinking for three days prior to randomization day.
Express a desire to achieve abstinence or to greatly reduce alcohol consumption.
Must have a stable residence and be able to identify an individual who could locate subject if needed.

Exclusion Criteria:

Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern (e.g., cirrhosis, unstable hypertension, seizure disorder, use of opiate medication).
Clinically significant psychiatric illness including: any psychotic disorder, bipolar disorder, severe depression, or suicidal ideation.
Other substance abuse or dependence disorder other than nicotine or alcohol.
Concurrent use of any psychotropic medication including antidepressants, mood stabilizers, antipsychotics, anxiolytics, stimulants, or hypnotics with the exception of stable doses of antidepressants for one month.
History of complicated alcohol withdrawal, i.e. withdrawal seizure or delirium tremens.
AST, or ALT > 3 times Upper Limit of Normal (ULN) or bilirubin > ULN.
Positive urine toxicology screen with the exception of cannabis. Individuals with positive cannabis screens will be excluded only if they have a history of cannabis dependence.
Pregnant women and women of childbearing potential who do not practice a medically acceptable form of birth control (oral or depot contraceptive, or barrier methods such as diaphragm or condom with spermicidal) and women who are breast feeding.
Individuals requiring inpatient treatment or more intense outpatient treatment for their alcohol dependence.
Participation in any clinical trial within the past 60 days.
Court-mandated participation in alcohol treatment or pending incarceration.
Intervention: Nicotine
Trial phase: Phase 3
ATC code: N07BA01
SMILES: CN1CCCC1c1cccnc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: 1 mg Oral NRT, up to 4 times per hour for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Subjects must be males or females 18 years of age or older who currently smoke cigarettes and are willing to stop smoking

Exclusion Criteria:

Subjects must not have a recent history of unstable angina, myocardial infarction or stroke
They must not have a suspected malignant and/or erosive oral lesion
Intervention: Moxifloxacin
Trial phase: Phase 1
ATC code: J01MA14 | S01AE07
SMILES: [H][C@@]12CCCN[C@]1([H])CN(c1c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c1OC)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 80
Group description: Moxifloxacin with placebo infusion
Eligibility criteria:
Inclusion Criteria:

Is overtly healthy, as determined by medical history and physical examination
Has body mass index (BMI) between 25 and 35 kg/m2
Has fasting serum glucose <110 mg/dL
Has no clinically significant blood pressure or heart rate readings as judged by the investigator at study start
Has electrocardiogram (ECG) results judged as not clinically significant by the investigator at study start

Exclusion Criteria:

Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being
Has an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, such as a Bazett's corrected QT (QTcB) interval >450 ms.
Family history of sudden death
Personal history of unexplained syncope within last year, or family history of Long QT Syndrome, or significant active cardiac disease, or symptoms of angina pectoris or transient ischemic attacks within the previous 6 months
Intervention: Clonidine
Trial phase: Phase 2
ATC code: C02AC01 | C02LC01 | C02LC51 | N02CX02 | S01EA04
SMILES: Clc1cccc(Cl)c1NC1=NCCN1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.

clonidine: Intrathecal Clonidine
Eligibility criteria:
Inclusion Criteria:

Diagnosis of Hypertension
Stable systolic blood pressure >140 mmHg and < 190 mmHg
On 3 or more antihypertensive medications
On a diuretic
Patients must be able to understand the risks

Exclusion Criteria:

Allergy to clonidine
Presently on clonidine orally or transdermally
Known or suspected correctable causes of secondary hypertension
Breast Feeding or Pregnant women
Unstable Ischemic Heart Disease
Unstable Angina
Intracoronary Stent Placement
Coronary bypass within last 6 months
Myocardial Infarction within last 6 months
Congestive Failure
Cardiac Arrhythmias
Known Cerebral Vascular Disease
Renal Disease
Evidence of Injection Site Infection
Known Bleeding Disorders
Hepatic Insufficiency
Renal Insufficiency
Participation in an investigational drug study within 30 day of enrollment

Prohibited Medications:

Clonidine
Yohimbine
Tricyclic Antidepressants
Mirtazapine
Digitalis
Reserpine
Guanethidine
Non-Steroidal Anti-inflammatory Medication
Alcohol or Barbiturates within 48 hours of study procedure
Intervention: Brinzolamide
Trial phase: Phase 3
ATC code: G01AE10 | S01EC04 | S01EC54
SMILES: CCN[C@H]1CN(CCCOC)S(=O)(=O)c2sc(S(N)(=O)=O)cc21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 226
Group description: Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
Eligibility criteria:
Inclusion Criteria:

Sign Informed Consent document.
Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
Any form of glaucoma other than open-angle glaucoma.
Severe central vision loss in either eye.
Chronic, recurrent, or severe inflammatory eye disease.
Ocular trauma within the preceding 6 months.
Ocular infection or ocular inflammation within the preceding 3 months.
Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product.
Ocular surgery within the preceding 6 months.
Ocular laser surgery within the preceding 3 months.
Any abnormality preventing reliable applanation tonometry.
Any other conditions, including severe illness, which could make the patient, in the opinion of the Investigator, unsuitable for the study.
Other protocol-specified exclusion criteria may apply.
Intervention: Brimonidine Tartrate
Trial phase: Phase 3
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 220
Group description: Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
Eligibility criteria:
Inclusion Criteria:

Sign Informed Consent document.
Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
Any form of glaucoma other than open-angle glaucoma.
Severe central vision loss in either eye.
Chronic, recurrent, or severe inflammatory eye disease.
Ocular trauma within the preceding 6 months.
Ocular infection or ocular inflammation within the preceding 3 months.
Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product.
Ocular surgery within the preceding 6 months.
Ocular laser surgery within the preceding 3 months.
Any abnormality preventing reliable applanation tonometry.
Any other conditions, including severe illness, which could make the patient, in the opinion of the Investigator, unsuitable for the study.
Other protocol-specified exclusion criteria may apply.
Intervention: Brimonidine Tartrate
Trial phase: Phase 3
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12.O=C(O)C(O)C(O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 235
Group description: Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
Eligibility criteria:
Inclusion Criteria:

Sign Informed Consent document.
Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
Any form of glaucoma other than open-angle glaucoma.
Severe central vision loss in either eye.
Chronic, recurrent, or severe inflammatory eye disease.
Ocular trauma within the preceding 6 months.
Ocular infection or ocular inflammation within the preceding 3 months.
Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product.
Ocular surgery within the preceding 6 months.
Ocular laser surgery within the preceding 3 months.
Any abnormality preventing reliable applanation tonometry.
Any other conditions, including severe illness, which could make the subject, in the opinion of the Investigator, unsuitable for the study.
Other protocol-specified exclusion criteria may apply.
Intervention: Desogestrel and ethinyl estradiol
Trial phase: Not Applicable
SMILES: C#CC1(O)CCC2C3CCC4=CCCCC4C3C(=C)CC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 70
Group description: OCP for IVF pre-treatment
Eligibility criteria:
Inclusion Criteria:

Patients less than 38 years of age.
Healthy women starting their first IVF/ICSI cycle.
No contraindication to Combined Oral Contraceptive (COC) use. Appendix 1
Consent to randomization.

Exclusion Criteria:

Any contraindication to COC use.
Hypersensitivity to Nuva ring or any of its components.
Language barrier to consent.
Intervention: Lubiprostone
Trial phase: Phase 3
ATC code: A06AX03
SMILES: [H][C@@]12CC(=O)[C@H](CCCCCCC(=O)O)[C@@]1([H])CC[C@](O)(C(F)(F)CCCC)O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 219
Group description: 24 mcg capsules twice daily (BID)

Lubiprostone: 24 mcg administered orally twice daily (BID)
Eligibility criteria:
Inclusion Criteria:

A patient can be considered for eligibility to participate if he/she:

Has been consistently treated for chronic, noncancer-related pain with any oral, transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to screening
Is diagnosed with OBD
Is capable of utilizing an electronic diary to report daily spontaneous bowel movements (SBMs)
Is willing to continue opioid therapy and discontinue the use of laxatives, stool softeners, and other concomitant medications affecting gastrointestinal motility throughout the study

Exclusion Criteria:

A patient cannot be considered for eligibility to participate if he/she:

Uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical bowel obstructions, bowel disorders, and constipation not arising from opioid use, but instead attributable to dietary, neurologic, congenital, or endocrine disorders, scleroderma, and/or for the management of drug addiction
Intervention: Bimatoprost
Trial phase: Phase 4
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 400
Group description: One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
Eligibility criteria:
Inclusion Criteria:

Ocular hypertension or glaucoma in each eye
Requires intraocular pressure (IOP)-lowering therapy in both eyes
Best corrected visual acuity of 20/100 or better in each eye

Exclusion Criteria:

Ocular seasonal allergies within 2 years
Required chronic use of ocular medications during the study (intermittent use of artificial tears is allowed)
Ocular surgery or laser within 3 months
Anticipated wearing of contact lenses during the study
Intervention: Bimatoprost
Trial phase: Phase 4
ATC code: S01EE03
SMILES: CCNC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 398
Group description: One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
Eligibility criteria:
Inclusion Criteria:

Ocular hypertension or glaucoma in each eye
Requires intraocular pressure (IOP)-lowering therapy in both eyes
Best corrected visual acuity of 20/100 or better in each eye

Exclusion Criteria:

Ocular seasonal allergies within 2 years
Required chronic use of ocular medications during the study (intermittent use of artificial tears is allowed)
Ocular surgery or laser within 3 months
Anticipated wearing of contact lenses during the study
Intervention: Mapracorat
Trial phase: Phase 3
SMILES: Cc1ccc2c(NC[C@](O)(CC(C)(C)c3cc(F)cc4c3OCC4)C(F)(F)F)cccc2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 120
Group description: Mapracorat ophthalmic suspension

Mapracorat: Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.
Eligibility criteria:
Inclusion Criteria:

Subjects who are candidates for routine, uncomplicated cataract surgery.
Subjects must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.

Exclusion Criteria:

Subjects who are expected to require treatment with any systemic or ocular (either eye) drugs specified in the protocol during the 18 days following cataract surgery or any systemic or ocular corticosteroids within 14 days prior to cataract surgery.
Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
Subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
Intervention: Acamprosate
Trial phase: Phase 2
ATC code: N07BB03
SMILES: CC(=O)NCCCS(=O)(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 12
Group description: The maximum dose of acamprosate to be used in this study is 1998 mg per day for those subjects weighing greater than 60kg and 1332 mg per day for those less weighing less than 60kg.
Eligibility criteria:
Inclusion Criteria:

Male and female outpatients between the ages of 5 and 17 years.
Confirmed diagnosis of Fragile X Syndrome based upon genetic testing.
Stable dosing of all psychotropic medications for at least 2 weeks prior to baseline.
Subjects with a stable seizure disorder or history of only childhood febrile seizures will be included.
Clinical Global Impression-Severity Score of 4 (Moderately Ill) or greater.
Must be in good physical health.
Subjects of child bearing age of both genders will be required to utilize birth control as applicable.

Exclusion Criteria:

Diagnosis of schizophrenia, another psychotic disorder, bipolar disorder or alcohol or other substance abuse based on Diagnostic and Statistical Manual Fourth Edition-Text Revised (DSM-IV-TR).
A significant medical condition such as heart, liver, renal or pulmonary disease or unstable seizure disorder.
Females with a positive urine pregnancy test
Creatinine clearance of less than 30.
Concomitant use of another glutamatergic agent (memantine,riluzole, d-cycloserine, amantadine topiramate, gabapentin, among others.
Evidence of hypersensitivity to acamprosate or potentially serious adverse effect.
Subjects who, in the opinion of the investigator, are unsuitable in any other way to participate in this study including being unable to comply with the requirements of the study for any reason.