anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Oxaliplatin
Trial phase: Phase 2
ATC code: L01XA03
SMILES: NC1CCCCC1N.O=C([O-])C(=O)[O-].[Pt+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.

FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6
Eligibility criteria:
Inclusion Criteria

Patients must consent to participate in the study and must have signed and dated an IRB-approved consent form conforming to federal and institutional guidelines
Patient must have histologically proven adenocarcinoma of the rectum with no distant metastases
Tumor stage must be T3N0M0, T1-3 N1M0 assessed by clinical exam, TRUS, MRI and CT. Pre-operative evidence of T4, N2 or distal lesions (0-6 cm from anal verge) should receive preoperative RT and not be offered this protocol. Any pT4, pN2 or CRM+ patients should be offered postoperative radiation
The proximal border of the tumor must be at or below 12 centimeters of the anal verge by proctoscopic examination
The distal border of the tumor must be at or above 6 cm from the anal verge on preoperative proctoscopy with the patient in the left lateral decubitus position
Patient must have had no prior chemotherapy or pelvic irradiation
Karnofsky performance status of 60 or greater; ECOG performance status 0-1
Patients should be age 18 years and older
Pretreatment absolute neutrophil count >= 1000/mm3 and platelets >= 100,000/mm3
Serum creatinine <= 1.5 x ULN; bilirubin <= 1.5 x ULN; ALT<= 2.5 x ULN

Exclusion Criteria

Patients can not be receiving any other investigational agents
Patients with known metastases will be excluded from the study
Patients with history of significant neuropathy or current symptoms of neuropathy
Patients with history of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin or 5-FU or leucovorin
Patients with uncontrolled intercurrent illness not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study because oxaliplatin and 5-FU/LV are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with oxaliplatin and 5-FU/LV, breastfeeding should be discontinued if the mother is treated with these agents
HIV positive patients
Patients with serious comorbid disease which prevents delivery of full treatment including psychiatric disorders and cardiopulmonary disease
No history within the past 5 years of a cancer diagnosis except for non-melanomatous skin cancers or in situ cervix carcinoma
Patients with clinically significant peripheral neuropathy at the time of start of treatment (defined in the NCI Common Terminology Criteria for Adverse Events Version 3[CTCAE v3.0] as grade 2 or greater neurosensory or neuromotor toxicity
Intervention: Dorzolamide Hydrochloride
Trial phase: Phase 2
SMILES: CCNC1CC(C)S(=O)(=O)c2sc(S(N)(=O)=O)cc21.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Patients who have not been treated with a glaucoma medication within 6 weeks prior to study participation after diagnosis with primary open-angle glaucoma
Patients with primary open-angle glaucoma based on gonioscopy
Patients with normal tension glaucoma diagnosed based on accompanying optic disc cupping and reappearance of visual field defect corresponding to retinal nerve fiber layer defect.
Subjects with < 22 mm Hg of diurnal IOP measured using Goldmann applanation tonometer (every two hours between 9 a.m. and 5 p.m.)

Exclusion Criteria:

Patients with another type of glaucoma but primary open-angle glaucoma
Patients treated with other glaucoma medications within 6 weeks prior to study participation
Patients with a history of chronic ocular inflammation or recurrent ocular inflammation
Patients using contact lenses
Patients who are allergic to timolol or dorzolamide

Patients with a history of any of the following COSOPT (timolol/dorzolamide combination) contraindications:

Reactive airway diseases
Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock
Severe renal impairment
Patients with a history of significant ocular trauma or intraocular surgery within 6 months before participating the study, or intraocular laser surgery within 3 months before the participating the study
Patients with a history of a corneal disease
Patients who are using steroid or used the drug for more than 2 weeks within 12 months before participating the study
Pregnant women
Intervention: Sitagliptin
Trial phase: Phase 4
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
Eligibility criteria:
Inclusion Criteria:

Patients Who Are 18 Years Of Age With Type 2 Diabetes Mellitus Who Are Either:

Not On Antihyperglycemic (AHa) Medication (Off For At Least 2 Months)
Or On A Single AHa
Intervention: Fesoterodine Fumarate
Trial phase: Phase 1
SMILES: CC(C)C(=O)Oc1ccc(CO)cc1C(CCN(C(C)C)C(C)C)c1ccccc1.O=C(O)C=CC(=O)O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 25
Group description: Fesoterodine 8 mg tablet once daily
Eligibility criteria:
Inclusion Criteria:

Healthy female subjects

Exclusion Criteria:

Evidence or history of clinically significant findings at screening
Intervention: Solifenacin
Trial phase: Phase 1
ATC code: G04BD08 | G04CA53
SMILES: O=C(O[C@H]1CN2CCC1CC2)N1CCc2ccccc2[C@@H]1c1ccccc1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: Solifenacin 10 mg capsule once daily
Eligibility criteria:
Inclusion Criteria:

Healthy female subjects

Exclusion Criteria:

Evidence or history of clinically significant findings at screening
Intervention: Mifepristone
Trial phase: Not Applicable
ATC code: G03XB01 | G03XB51
SMILES: [H][C@@]12CC[C@@](O)(C#CC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: 200 mg RU-486 (Mifepristone) daily

Mifepristone: Mifepristone 200 mg will be administered orally
Eligibility criteria:
Inclusion Criteria:

All patients 18 years of age or older.
Patients must sign an informed consent.
Patients should be in such a health condition in the opinion of the attending physician that with the administration of mifepristone benefits may outweigh risks.

Exclusion Criteria:

Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
Intervention: Ibuprofen
Trial phase: Not Applicable
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 9
Group description: Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old

Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose
Eligibility criteria:
Inclusion Criteria:

Birth weight less than 1200gm
Less than 28 weeks gestational age
Confirmed Patent Ductus Arteriosus (PDA) via echocardiogram and clinical exam

Exclusion Criteria:

Active Bleeding
Currently being treated for Persistent Pulmonary Hypertension (PPHN)
Cardiac anomalies
Chromosomal abnormalities
Endocrine, metabolic, renal, or hepatic disorders
Intervention: Ibuprofen
Trial phase: Not Applicable
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 6
Group description: Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.

Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg
Eligibility criteria:
Inclusion Criteria:

Birth weight less than 1200gm
Less than 28 weeks gestational age
Confirmed Patent Ductus Arteriosus (PDA) via echocardiogram and clinical exam

Exclusion Criteria:

Active Bleeding
Currently being treated for Persistent Pulmonary Hypertension (PPHN)
Cardiac anomalies
Chromosomal abnormalities
Endocrine, metabolic, renal, or hepatic disorders
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: 41
Group description: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.

Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

18 years of age or older;
meet DSM-IV criteria for methamphetamine dependence;
seeking treatment for MA problems;
specific range of methamphetamine use in the 30 days prior to study entry;
willing and able to comply with study procedures, including genotyping;
willing and able to provide written informed consent;
if female, not pregnant or lactating and willing to use an acceptable method of barrier birth control (e.g. condoms) during the trial.

Exclusion Criteria:

have a medical condition that, in the study physician's judgment, may interfere with safe study participation (e.g., active TB, unstable cardiac, renal, or liver disease, unstable diabetes);
have a current neurological disorder (e.g., organic brain disease, dementia) or major psychiatric disorder not due to substance abuse (e.g., schizophrenia, bipolar disorder) as assessed by the SCID or a medical history which would make study agent compliance difficult or which would compromise informed consent, or recent (past 30 days) history of suicide attempts and/or current serious suicidal intention or plan as assessed by the SCID;
currently on prescription medication that is contraindicated for use with bupropion;
have current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV-TR;
have a history of alcohol dependence within the past three years;
have a history of a seizure disorder;
have a medical condition (such as serious head injury) that is associated with increased risk of seizures or on a medication that lowers the seizure threshold;
have a history of anorexia or bulimia;
have current hypertension uncontrolled by medication, or any other circumstances that, in the opinion of the investigators, would compromise participant safety;
have a history of sensitivity to bupropion.
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: 43
Group description: Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

18 years of age or older;
meet DSM-IV criteria for methamphetamine dependence;
seeking treatment for MA problems;
specific range of methamphetamine use in the 30 days prior to study entry;
willing and able to comply with study procedures, including genotyping;
willing and able to provide written informed consent;
if female, not pregnant or lactating and willing to use an acceptable method of barrier birth control (e.g. condoms) during the trial.

Exclusion Criteria:

have a medical condition that, in the study physician's judgment, may interfere with safe study participation (e.g., active TB, unstable cardiac, renal, or liver disease, unstable diabetes);
have a current neurological disorder (e.g., organic brain disease, dementia) or major psychiatric disorder not due to substance abuse (e.g., schizophrenia, bipolar disorder) as assessed by the SCID or a medical history which would make study agent compliance difficult or which would compromise informed consent, or recent (past 30 days) history of suicide attempts and/or current serious suicidal intention or plan as assessed by the SCID;
currently on prescription medication that is contraindicated for use with bupropion;
have current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV-TR;
have a history of alcohol dependence within the past three years;
have a history of a seizure disorder;
have a medical condition (such as serious head injury) that is associated with increased risk of seizures or on a medication that lowers the seizure threshold;
have a history of anorexia or bulimia;
have current hypertension uncontrolled by medication, or any other circumstances that, in the opinion of the investigators, would compromise participant safety;
have a history of sensitivity to bupropion.
Intervention: Citalopram
Trial phase: Phase 4
ATC code: N06AB04 | N06AB10
SMILES: CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
Eligibility criteria:
Inclusion Criteria:

Women ages 18 to 45 years old
Subjects must meet criteria for a major depressive episode with symptoms developing within three month of live childbirth
Subjects must present within six months of childbirth
MADRS score >15
BAI score >10
Subjects will be able to be treated on an outpatient basis
Subjects will be able to provide written informed consent

Exclusion Criteria:

Subjects who have taken any psychotropic medication, including antidepressants and anti-anxiety medication, within the past two weeks (with the exception of non-benzodiazepine medications used for sleep, including trazodone, zolpidem, eszopiclone, etc)
Suicidal ideation with active plan or intent, as determined by the investigator
Presence of psychotic symptoms or homicidal ideation
History of mania or hypomania
Pregnant or breastfeeding
Presence of chronic depression or dysthymia, or chronic or treatment resistant anxiety disorders, as determined by investigator
Active alcohol/substance abuse currently or within the past year
Abnormal TSH, severe anemia, or uncontrolled hypertension
Intervention: Voriconazole
Trial phase: Phase 1
ATC code: J02AC03
SMILES: C[C@@H](c1ncncc1F)[C@](O)(Cn1cncn1)c1ccc(F)cc1F
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
Eligibility criteria:
Inclusion Criteria:

Healthy participants as determined by no clinically significant deviation from normal
Body Mass Index (BMI) of 18 to 32 kg/m^2, inclusive. BMI=weight(kg)/height (m)^2
Women who are not of childbearing potential (WOCBP)(ie, who are postmenopausal or surgically sterile) and men, ages 18 to 45 years, inclusive

Exclusion Criteria:

WOCBP
Sexually active fertile men not using effective birth control if their partners are WOCBP
Proven or suspected acute hepatitis (within 12 months prior to the 1st dose)
Any significant acute or chronic medical illness
Any gastrointestinal surgery that could impact on the absorption of study drug
Smoking more than 5 cigarettes per day
History of any hemolytic disorders (including drug-induced hemolysis)
History of acute or chronic pancreatitis
History of hypochlorhydria or achlorhydria
Men and women weighing <40 kg
Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 or HIV-2 antibody
Patients with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Intervention: Zopiclone
Trial phase: Not Applicable
ATC code: N05CF01 | N05CF04
SMILES: CN1CCN(C(=O)OC2c3nccnc3C(=O)N2c2ccc(Cl)cn2)CC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 25
Group description: 3mg of eszopiclone on two consecutive nights
Eligibility criteria:
Inclusion Criteria:

Clinically stable outpatients with DSM-IV diagnoses of Schizophrenia

Exclusion Criteria:

History of neurologic or psychiatric disease other than schizophrenia
Substance abuse or dependence within the past six months
Other chronic medical conditions that affect sleep
Pregnancy/breast feeding
Hepatic impairment
Treatment with metabolic inhibitors or inducers
Intervention: Ketamine
Trial phase: Not Applicable
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
Eligibility criteria:
Inclusion Criteria for Group 1

Subject will be between ages 18 to 65 years.
Subject has a chronic pain condition for at least three months. This requirement is set in order to avoid the clinical uncertainty of an unstable pain condition and to minimize the study variation. Subjects should have a VAS pain score at 4 or above at the time of study.
Subject is on a chronic opioid treatment regimen (e.g., morphine, fentanyl, oxycodone, methadone, hydromorphone, hydrocodone) for at least three months. There should have been no changes in the type and amount of opioid dose for at least one month. Only patients with a minimal daily dose of at least 60 mg morphine equianalgesic dose will be included.

Inclusion Criteria for Group 2

Subject who meets the criteria #1 & #2 as listed for Group 1.
Subject has not been on an opioid regimen for the last three or more months.

Exclusion Criteria for all groups:

Subject has an altered sensation at the skin site of QST (one of upper extremities).
Subject has scar tissue or acute injury at the skin site of QST.
Subject has neurological disease or a condition causing upper extremities or generalized polyneuropathy, such as diabetic neuropathy, alcoholic neuropathy, AIDS neuropathy, multiple sclerosis, amyotrophic lateral sclerosis, and post-stroke residual neurological deficits.
Subject has a diagnosis of renal or liver failure.
Subject has a diagnosis of unstable angina, congestive heart failure, cardiac arrythmias or myocardial infarction within 1 year.
Subject is allergic to ketamine.
Subject had recent therapy that may influence QST results, e.g., neuroablative procedure involving upper extremities within six-months or peripheral neurolytic block involving upper extremities within two-months.
Subject has a confirmed diagnosis of and is under the care of a psychiatrist for major depression disorder, eating disorder; alcohol or drug dependence; or attention deficit hyperactivity disorder. Subject has any history of a confirmed diagnosis of bipolar disorder, schizophrenia, anxiety disorder or a psychotic disorder
Subject is tested positive on drug urine screening test.

Subject is pregnant or breast-feeding.

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Intervention: Ketamine
Trial phase: Not Applicable
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
Eligibility criteria:
Inclusion Criteria for Group 1

Subject will be between ages 18 to 65 years.
Subject has a chronic pain condition for at least three months. This requirement is set in order to avoid the clinical uncertainty of an unstable pain condition and to minimize the study variation. Subjects should have a VAS pain score at 4 or above at the time of study.
Subject is on a chronic opioid treatment regimen (e.g., morphine, fentanyl, oxycodone, methadone, hydromorphone, hydrocodone) for at least three months. There should have been no changes in the type and amount of opioid dose for at least one month. Only patients with a minimal daily dose of at least 60 mg morphine equianalgesic dose will be included.

Inclusion Criteria for Group 2

Subject who meets the criteria #1 & #2 as listed for Group 1.
Subject has not been on an opioid regimen for the last three or more months.

Exclusion Criteria for all groups:

Subject has an altered sensation at the skin site of QST (one of upper extremities).
Subject has scar tissue or acute injury at the skin site of QST.
Subject has neurological disease or a condition causing upper extremities or generalized polyneuropathy, such as diabetic neuropathy, alcoholic neuropathy, AIDS neuropathy, multiple sclerosis, amyotrophic lateral sclerosis, and post-stroke residual neurological deficits.
Subject has a diagnosis of renal or liver failure.
Subject has a diagnosis of unstable angina, congestive heart failure, cardiac arrythmias or myocardial infarction within 1 year.
Subject is allergic to ketamine.
Subject had recent therapy that may influence QST results, e.g., neuroablative procedure involving upper extremities within six-months or peripheral neurolytic block involving upper extremities within two-months.
Subject has a confirmed diagnosis of and is under the care of a psychiatrist for major depression disorder, eating disorder; alcohol or drug dependence; or attention deficit hyperactivity disorder. Subject has any history of a confirmed diagnosis of bipolar disorder, schizophrenia, anxiety disorder or a psychotic disorder
Subject is tested positive on drug urine screening test.

Subject is pregnant or breast-feeding.

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