anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: (3S)-3,4-Propano-2,3-dihydropyrido[3,2-f][1,4]oxazepine-5(4H)-one
Trial phase: Phase 2
SMILES: O=C1c2cccnc2OCC2CCCN12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
Eligibility criteria:
Inclusion Criteria:

Female who is non-pregnant, nonlactating, using an acceptable method of birth control, or is not of child-bearing potential;
be diagnosed with current major depressive disorder either mild or severe, as evidenced by a score of at least 9 but not more than 20 on the Quick Inventory of Depression Symptomatology - Clinician Rated (QIDS-C);
be anti-depressant naïve;
be able to refrain from all use of grapefruit containing products from the time of admission until the last assessment is performed at discharge;
smokes less than or equal to 10 cigarettes or equivalent daily.

Exclusion Criteria:

has any current and primary Axis I disorder other than major depressive disorder;
has any history of bipolar I or II disorder, dysthymia, psychotic depression, psychotic disorders, posttraumatic stress disorder, borderline personality disorder, obsessive compulsive disorder, or eating disorder;
the duration of the current depressive episode is longer than 2 years at screening;
has any history of a significant suicide attempt, or poses a current risk of attempting suicide;
is known to be human immunodeficiency virus (HIV) positive, or positive for hepatitis B surface antigen or hepatitis A antibodies or hepatitis C total antibodies;
has any clinically significant concurrent endocrine, renal, respiratory, cardiovascular, hematological, immunological, cerebrovascular, neurological, malignancy, or any other concurrent medical condition, or has any history of diabetes mellitus;
donation of blood within 60 days prior to the anticipated first dose of trial medication.
Intervention: (3S)-3,4-Propano-2,3-dihydropyrido[3,2-f][1,4]oxazepine-5(4H)-one
Trial phase: Phase 2
SMILES: O=C1c2cccnc2OCC2CCCN12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
Eligibility criteria:
Inclusion Criteria:

Female who is non-pregnant, nonlactating, using an acceptable method of birth control, or is not of child-bearing potential;
be diagnosed with current major depressive disorder either mild or severe, as evidenced by a score of at least 9 but not more than 20 on the Quick Inventory of Depression Symptomatology - Clinician Rated (QIDS-C);
be anti-depressant naïve;
be able to refrain from all use of grapefruit containing products from the time of admission until the last assessment is performed at discharge;
smokes less than or equal to 10 cigarettes or equivalent daily.

Exclusion Criteria:

has any current and primary Axis I disorder other than major depressive disorder;
has any history of bipolar I or II disorder, dysthymia, psychotic depression, psychotic disorders, posttraumatic stress disorder, borderline personality disorder, obsessive compulsive disorder, or eating disorder;
the duration of the current depressive episode is longer than 2 years at screening;
has any history of a significant suicide attempt, or poses a current risk of attempting suicide;
is known to be human immunodeficiency virus (HIV) positive, or positive for hepatitis B surface antigen or hepatitis A antibodies or hepatitis C total antibodies;
has any clinically significant concurrent endocrine, renal, respiratory, cardiovascular, hematological, immunological, cerebrovascular, neurological, malignancy, or any other concurrent medical condition, or has any history of diabetes mellitus;
donation of blood within 60 days prior to the anticipated first dose of trial medication.
Intervention: Esmirtazapine maleate
Trial phase: Phase 3
SMILES: CN1CCN2c3ncccc3Cc3ccccc3C2C1.O=C(O)C=CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 342
Group description: One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
Eligibility criteria:
Inclusion Criteria:

sign written informed consent after the scope and nature of the investigation have been explained to them, before any trial-related evaluations;
completed Protocol P05706 or P05707;
Have safety and efficacy assessments conducted per protocol P05706 or P05707.

Exclusion Criteria:

clinically relevant electrocardiogram (ECG) abnormalities as judged by the investigator;
clinically relevant abnormal laboratory values as judged by the investigator;
any adverse event deemed relevant for exclusion in Protocol P05708 as judged by the investigator or,
were significantly non compliant with protocol criteria and procedures of Protocol P05706 or P05707, as judged by the investigator.
Intervention: Cefazolin
Trial phase: Not Applicable
ATC code: J01DB04
SMILES: [H][C@]12SCC(CSc3nnc(C)s3)=C(C(=O)O)N1C(=O)[C@H]2NC(=O)Cn1cnnn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 75
Group description: Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.

cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours.
Eligibility criteria:
Inclusion Criteria:

Patients 18 years or older;
Scheduled for primary osteosynthesis or placement of a prosthetic device in the treatment of closed limb fractures;
Ability to give informed consent.

Exclusion Criteria:

Known hypersensitivity to cephalosporins;
Antimicrobial use or symptoms of infection in the week before surgery;
Pregnancy;
Immunosuppressive treatment;
Inability to give informed consent.
Intervention: Vigabatrin
Trial phase: Phase 2
ATC code: N03AG04
SMILES: C=CC(N)CCC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Vigabatrin Tablets, 1.5 g bid po, 12 weeks. Subjects proceeded to a 12 week Treatment Phase, including a 2 week dose escalation period, a 9 week maintenance period (3.0 gm/day of vigabatrin), and a 1 week medication taper period. Finally, subjects then proceeded to a 12 week follow-up period. Subjects were scheduled for clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
Eligibility criteria:
Inclusion Criteria:

Able to understand the study and provide written informed consent.
Male or female at least 18 years of age.
Meets DSM-IV (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition) criteria for cocaine dependence as primary diagnosis, as determined by the Substance Abuse module of SCID (Structured Clinical Interview for DSM-IV).
Provide at least one urine sample that is positive for cocaine according to a rapid screening test.
Seeking treatment for cocaine dependence.
Have normal visual fields.
Be in generally good health based on history, physical examination, electrocardiogram and laboratory findings.
If female of childbearing potential, use acceptable contraceptive methods. (oral contraceptives (the pill), IUDs, contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, and condoms with spermicide). Surgical sterilization by tubal ligation or hysterectomy is acceptable

Exclusion Criteria:

Has current dependence, as determined by the SCID, on any psychoactive substance other than cocaine, alcohol, nicotine, or marijuana or physiologic dependence on alcohol requiring medical detoxification.
Has any serious medical or psychiatric illness and/or clinically significant abnormal laboratory value, which in the judgment of the Principal Investigator or his/her designee would make study participation unsafe, or would make treatment compliance difficult or put the study staff at undue risk.
Be under court mandate to obtain treatment.
Be enrolled in an opiate substitution treatment program within 2 months of randomization.
Has ever taken vigabatrin in the past.
Is pregnant or lactating.
Has clinically significant ophthalmologic disease, which would preclude safety monitoring or is undergoing treatment for ocular disease.
Has received a drug with known major organ toxicity, including retinotoxicity within 30 days of randomization.
Is currently participating in, or has been enrolled in another clinical trial within the last 30 days.
Be anyone who, in the judgment of the investigator, would not be expected to attend regular study visits or to complete the study protocol, due to imminent relocation from the clinic area, legal difficulties, work-related problems, transportation, etc.
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
Healthy volunteers: No
Participants at risk: 68
Group description: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
Eligibility criteria:
Inclusion Criteria:

Patient is scheduled for bilateral LASIK surgery
Patient is in good general health
Eye glasses prescription of -1 to -8

Exclusion Criteria:

Significant Dry Eye
Presence of eye disease
Uncontrolled systemic disease
Intervention: Lubiprostone
Trial phase: Not Applicable
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: Accepts Healthy Volunteers
Participants at risk: 191
Group description: split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
Eligibility criteria:
Inclusion Criteria:

Adult patients referred to our clinic for Average or Increased Risk screening for Colorectal Cancer
Ages will be from 18 years of age and older

Exclusion Criteria:

Chronic kidney disease
Previous diagnosis of congestive heart failure
History of bowel obstruction
History of solid organ transplant
Pregnancy
Intervention: Atomoxetine
Trial phase: Not Applicable
ATC code: N06BA09
SMILES: CNCC[C@@H](Oc1ccccc1C)c1ccccc1
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 16
Group description: Atomoxetine: Subjects will receive ATX 40mg/d x 1 week, then 80mg/d x 5 weeks followed by a 4-week wash out period that is followed by an additional 6 weeks of treatment in the alternate condition. The 4-week washout period include a 4-day taper in the first week.
Eligibility criteria:
Inclusion Criteria:

Menopausal subjects between the ages of 45 and 60 years;
Physically healthy with no major medical illnesses;
No history within the past 5 years of a DSM-IV psychiatric or substance abuse diagnosis by structured diagnostic interview (SCID);
Subjects will be determined to be either peri or post-menopausal;
Subjects must be within 5 years of their last menstrual period;
Subjective report of cognitive disturbances of at least mild to moderate severity;
All subjects must be of at least average intelligence as determined using the Wechsler Abbreviated Scale of Intelligence (WASI).

Exclusion Criteria:

Clinical evidence of dementia and/or signs of dementia on the Mini-Mental Status Exam (MMSE score of <22);
History of familial dementia;
Use of any psychotropic medication within the previous 6 months;
Use of any estrogen replacement therapy within the previous 6 months;
Current pregnancy;
Signs of an unstable medical or neurological disorder.
Intervention: Thiopental
Trial phase: Not Applicable
ATC code: N01AF03 | N05CA19 | N05CB01
SMILES: CCCC(C)C1(CC)C(=O)NC(=S)NC1=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 73
Group description: Family History Negative for Alcoholism subjects will receive 2 interventions

Thiopental: A 2-day test design involving 2 conditions: saline (Placebo) or Thiopental 1.5mg/kg (loading) with a subsequent infusion rate of 40 mcg/kg/minute (60 minute infusion).
Eligibility criteria:
Inclusion Criteria:

Male and female between the ages of 21 and 30 years
medically and neurologically healthy on the basis of history, physical examination, Electrocardiogram (EKG), screening laboratories
absence of any evidence of substance abuse (with the exception of nicotine dependence) on the basis of history and drug and ethanol-free at the time of testing based on urine toxicology and breath alcohol levels at screening and on each test day.

Exclusion Criteria:

Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) Axis I psychiatric and substance abuse or dependence diagnosis by history on psychiatric evaluation that includes a structured diagnostic interview (SCID)
unwillingness to remain alcohol-free for three days prior to each test day;
for women, positive pregnancy test at screening or intention to engage in unprotected sex during the study and
alcohol naive. For Family History Positive Subjects: 1) Biological father and another first or second-degree biological relative with history of alcoholism by Family History Assessment Module (FHAM) developed by The Collaborative Study on the Genetics of Alcoholism (COGA).

For Family History Negative Subjects: NO family history of alcoholism in any first or second-degree relatives. Subjects must reliably report on three first-degree relatives.
Intervention: Flutamide
Trial phase: Phase 4
ATC code: L02BB01
SMILES: CC(C)C(=O)Nc1ccc([N+](=O)[O-])c(C(F)(F)F)c1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Flutamide: Participants will take one 125-mg flutamide capsule twice a day for two menstrual cycles. If a participant is unable to tolerate a twice-daily dose due to side effects, the dose will be reduced to one capsule per day.
Eligibility criteria:
Inclusion Criteria:

Meets DSM-IV criteria for PMDD by history
Regular menstrual cycles that are 25 to 35 days in length during the year prior to study entry
Willing to use barrier methods of birth control during the study if sexually active
If engaged in psychotherapy for at least 3 months before study entry, participation will be allowed if the intensity of psychotherapy remains the same during the study
Normal PAP and physical exam, including pelvic exam, within the 1 year prior to study entry

Exclusion Criteria:

Use of oral contraceptives or other exogenous hormone preparations within the 3 months prior to study entry
Suicide attempt or severe suicidal ideation within the 2 years prior to study entry
History of any psychotic disorder or bipolar disorder
Substance abuse, except nicotine, within the 6 months prior to study entry
Use of pharmacological treatment for PMDD symptoms (e.g., antidepressants, hormones, gonadotropin-releasing hormone agonists, anxiolytics, calcium, herbal preparations, diuretics) within the 3 months prior to study entry
Daily use of psychotropic or anticonvulsant medications within the 3 months prior to study entry
Use of sleeping pills more than once per week
Consumption of more than 50 ounces of alcohol per week
Pregnant or breastfeeding
Hepatic, renal, autoimmune, or chronic inflammatory disease
Seizure disorder
Inability to read or follow instructions in English
Intervention: EZOGABINE
Trial phase: Phase 2
ATC code: N03AX21
SMILES: CCOC(=O)Nc1ccc(NCc2ccc(F)cc2)cc1N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 125
Group description: Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant's MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
Eligibility criteria:
Inclusion Criteria:

Ability to provide informed consent
Male or female subjects
18-85 years of age
PHN for more than 6 months after the healing of herpes zoster skin rash
Has a pain score at screening and randomization that qualifies

Exclusion Criteria:

Other significant pain that may potentially confound PHN pain assessment
Previous neurolytic or neurosurgical therapy for PHN
Subject has evidence of a progressive central nervous system (CNS) disease (e.g. CNS lupus, tumors, multiple sclerosis, Alzheimer's), lesion, or encephalopathy
Significant psychiatric or neuropsychiatric disorders including but not limited to severe depression, bipolar disorder or schizophrenia spectrum disorder, history of suicide attempt, or recent history of suicidal ideation
Has clinically significant abnormalities on physical examination, vital signs, ECG, or laboratory tests at the screening visit
Intervention: Ibuprofen and famotidine
Trial phase: Phase 3
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1.NC(N)=Nc1nc(CSCCC(N)=NS(N)(=O)=O)cs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 132
Group description: HZT-501: ibuprofen 800mg/famotidine 26.6mg
Eligibility criteria:
Inclusion Criteria:

Expected to continue to require daily administration of an NSAID for at least the coming 6 months.
Subject completed the 24-week Treatment period of either Horizon Protocol HZ-CA-301 or HZ-CA-303

Exclusion Criteria:

Subject didn't meet all of the Inclusion and Exclusion Criteria for Horizon Protocol HZ-CA-301 or HZ-CA-303
Subject developed or experienced any of the following while on either HZ-CA-301 or HZ-CA-303
Malignant Disease of the gastrointestinal tract
Erosive esophagitis
Clinically significant cardiac, renal or hepatic disease
Uncontrolled diabetes
Positive pregnancy test on Study Day 0
Please note that there are other additional criteria. The study center will determine if you meet all of the criteria.
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.

Lidocaine: 5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.
Eligibility criteria:
Inclusion Criteria:

Good general health
Age>18years
English speaking
Voluntarily requesting pregnancy termination
Have an estimated gestation of up to 76 days since the first day of the preceding menstrual period
Confirmed by ultrasound
Be able and willing to sign an informed consent
Agree to the terms of the study
All patients must be premedicated with Ibuprofen and Valium (per clinic protocols)

Exclusion Criteria:

Significant physical or mental health condition
A gestational age of 77 days or more
Adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease
Patients who require or request IV/intramuscular sedation
Patients who refuse Ibuprofen, Valium and/or paracervical blocks
Patients allergic to lidocaine
Patients with known hepatic disease
Patients weighing less than 100 lbs
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.

Lidocaine: Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.
Eligibility criteria:
Inclusion Criteria:

Good general health
Age>18years
English speaking
Voluntarily requesting pregnancy termination
Have an estimated gestation of up to 76 days since the first day of the preceding menstrual period
Confirmed by ultrasound
Be able and willing to sign an informed consent
Agree to the terms of the study
All patients must be premedicated with Ibuprofen and Valium (per clinic protocols)

Exclusion Criteria:

Significant physical or mental health condition
A gestational age of 77 days or more
Adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease
Patients who require or request IV/intramuscular sedation
Patients who refuse Ibuprofen, Valium and/or paracervical blocks
Patients allergic to lidocaine
Patients with known hepatic disease
Patients weighing less than 100 lbs
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: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 58
Group description: Participants receive transcervical instillation of 5 ml 4% lidocaine solution 3 minutes prior to transcervical tubal sterilization
Eligibility criteria:
Inclusion Criteria:

Female
Age 18 or older
Good general health, based on the opinion of the investigator
Voluntarily requesting permanent sterilization
Negative pregnancy test
Agree to premedication with ibuprofen and ativan
English speaking, or other language if an interpreter is available to be present at all points of the study procedure.
Willing and able to sign an informed consent
Willing to comply with the terms of the study

Exclusion Criteria:

Significant physical or mental health condition, based on the opinion of the investigator.
Positive pregnancy test
Request for IV/IM sedation prior to the start of the procedure
Refusal of ibuprofen, ativan, or paracervical block
Allergy to any study medication including lidocaine, ibuprofen, ativan, sodium bicarbonate
History of toxic reaction to local anesthetics
Known hepatic disease or liver dysfunction. (Lidocaine is metabolized by the liver.)
Weight less than 100 pounds. [Any patient weighing less than 100 pounds would receive more than the recommended dose for their weight (4.5 mg/kg or 2 mg/lb)].
Current participation in another research study which would interfere with the conduct of this study.