anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ketotifen Fumarate
Trial phase: Phase 3
SMILES: CN1CCC(=C2c3ccccc3CC(=O)c3sccc32)CC1.O=C(O)C=CC(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 152
Group description: Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Patients aged between 7 and 15 years
Patients giving assent and whose legal guardian giving informed consent
Outpatients
Patients diagnosed as atopic dermatitis
Patients who require the treatment with topical corticosteroid on areas other than face, head and neck
Patients whose diaries can be properly maintained
Patients who have 2 grades or more pruritus score

Exclusion Criteria:

Patients with bronchial asthma who require concomitant use of the corticosteroid
Patients who have been undergoing specific desensitization therapy or nonspecific immunomodulation therapy or phototherapy
Patients with current or previous history of drug hypersensitivity
Patients who have been treated with Bepotastine besilate in the past
Patients who have; a skin infection, or with zooparasite such as scabies and pediculosis; eczematous otitis externa with perforation in the eardrum; dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2; on areas where topical corticosteroid is applied
Patients who have spastic disease such as epilepsy
Patients who concurrently have renal function abnormalities that may cause safety problems
Patients who do not give consent to use birth control
Pregnant patients, at risk of pregnancy or breastfeeding
Patients who had participated in any clinical trial in the last 12 weeks
Intervention: Ondansetron
Trial phase: Phase 2
ATC code: A04AA01
SMILES: Cc1nccn1CC1CCc2c(c3ccccc3n2C)C1=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 57
Group description: Patients receiving pre-spinal ondansetron
Eligibility criteria:
Inclusion Criteria:

Elective CD under spinal anesthesia
Fluency in English

Exclusion Criteria:

Contraindication to spinal anesthesiA
Allergy to ondansetron
Intervention: Estradiol
Trial phase: Early Phase 1
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.

IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol.
Eligibility criteria:
Inclusion Criteria:

Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Be at least 18 years of age at time of informed consent.
Have had a diagnosis of CLE
Currently has active CLE (any subtype) established by standard clinical and histo- and immunopathologic criteria
Falls into one of the two following cohorts:
Cohort 1 - Has received a standard systemic therapy without a therapeutic response for a minimum of one month
Cohort 2 - Has not received any systemic treatment

Exclusion Criteria:

Subject is not over 18 years of age.
Subject cannot understand or follow directions.
Subject is a female of child-bearing potential and unwilling to use a form of highly effective birth control.
Subject is pregnant, planning to get pregnant, or breast feeding.
Subject has a known history of immunoglobulin A (IgA) deficiency.
Intervention: Amlexanox
Trial phase: Phase 2
ATC code: A01AD07 | R03DX01
SMILES: CC(C)c1ccc2oc3nc(N)c(C(=O)O)cc3c(=O)c2c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Amlexanox
Eligibility criteria:
Inclusion Criteria:

≥ 18 years old at baseline and <60 years of age.

Is male, female not of childbearing potential, or meets all the following criteria if female of childbearing potential (including perimenopausal women who have had a menstrual period within one year):

Not breastfeeding.
Negative pregnancy test result (human chorionic gonadotropin, beta subunit [βhCG]) at baseline (not applicable to hysterectomized females).
Must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate when use consistently and correctly, such as implants, injectables, oral contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation, or a vasectomized partner) during the entire duration of study period.
Has physician-confirmed diabetes mellitus with a clear diagnosis or per ADA criteria with fasting glucose>126 mg/dL or HbA1c >6.4% or 2 hour GTT >200 mg/dL or or pre-diabetes with fasting glucose >100 mg/dL (n= up to 8)
BMI ≥27 and <36 kg/m2.
On no medications or only on first line oral medications (such as Metformin and/or DPP IV inhibitors) for treatment of type 2 diabetes mellitus with a stable regimen for >12 weeks.
Alcohol consumption of less than 40 grams/week.
A liver US confirming presence of fatty infiltration of the liver.
Is able to read, understand and sign the U of M IRBMED approved informed consent form (ICF), communicate with study physician and study team, understand and comply with protocol requirements.

Exclusion Criteria:

On insulin, sulfonylurea or other injectables for treatment of type 2 diabetes
Unable to conduct home based glucose monitoring
HbA1c>9.5%
Presence of advanced liver disease (as evidenced by abnormal synthetic function, abnormal PT or albumin).
Evidence of other etiologies of viral hepatitis.
Presence of hematologic, bone marrow and/or other abnormalities.
Presence of hemoglobinopathy or other hematological abnormalities that will interfere with accurate measurement of HbA1c
Presence of HIV infection.
Inability to give informed consent.
Presence of ESRD, any type of active cancer, or >class 2 congestive heart failure (New York Heart Association Functional Classification System), based on medical history and physical examination.
Active chronic infection such as known chronic osteomyelitis or tb, etc. (may be transient).
Creatinine >1.5 mg/dL
Proliferative diabetic retinopathy, nonproliferative retinopathy is allowed
Unable to ambulate
Clinically relevant CAD: history of stent, CABG or cardiologist confirmed angina
Any other condition in the opinion of the investigators that may impede successful data collection.
Intervention: Pirosal
Trial phase: Phase 3
SMILES: CC(=O)Nc1ccc(O)cc1.Cc1c(N(C)CS(=O)(=O)[O-])c(=O)n(-c2ccccc2)n1C.Cn1c(=O)c2c(ncn2C)n(C)c1=O.[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 62
Group description: Participants were administered with two caplets of paracetamol/caffeine combination 500/65mg plus 2 placebo caplets orally with 8 ounce of water
Eligibility criteria:
Inclusion Criteria:

Participants in good general health, and with diagnosis of ETTH with following conditions:

number of days with the condition is historically greater than or equal to two per month;
severity of headaches is historically at least moderate;

duration of headaches is historically more than or equal to 4 hours, if untreated.

Exclusion Criteria:

Participant with known or suspected hypersensitivity, allergy, intolerance or contraindication to the use of any of the study medications
Participant has chronic tension type headache, psychiatric disease or a significant cognitive disorder, or any chronic pain disorder.
Participant currently taking or has taken medications or herbal supplements within the three months that are likely to interfere with the validity of subject-rated assessments.
Intervention: Ibuprofen
Trial phase: Phase 3
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: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 62
Group description: Participants were administered with two caplets of ibuprofen 200mg plus 2 placebo caplets orally with 8 ounce of water
Eligibility criteria:
Inclusion Criteria:

Participants in good general health, and with diagnosis of ETTH with following conditions:

number of days with the condition is historically greater than or equal to two per month;
severity of headaches is historically at least moderate;

duration of headaches is historically more than or equal to 4 hours, if untreated.

Exclusion Criteria:

Participant with known or suspected hypersensitivity, allergy, intolerance or contraindication to the use of any of the study medications
Participant has chronic tension type headache, psychiatric disease or a significant cognitive disorder, or any chronic pain disorder.
Participant currently taking or has taken medications or herbal supplements within the three months that are likely to interfere with the validity of subject-rated assessments.
Intervention: Buprenorphine Hydrochloride
Trial phase: Phase 3
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5.Cl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Buprenorphine/naloxone via physician office (B-PO) x 10 months

buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
Eligibility criteria:
Inclusion Criteria:

Enrollment in the Drug Treatment Court
diagnosis of opioid dependence using the Addiction Severity Index-Lite and diagnosis by clinical staff of referring units
opioid positive urine drug screen at baseline
women of childbearing potential who have a negative screening urine pregnancy test and are willing to use reliable birth control methods throughout the duration of the study.

Exclusion Criteria:

pregnancy
women who are currently breastfeeding
complex psychiatric co-morbidity (e.g. suicidality, psychosis)
complex medical co-morbidity (e.g. major cardiovascular, renal, or gastrointestinal/hepatic disease)
or current pharmacotherapy with an agent which is contraindicated in combination with buprenorphine/naloxone according to drug labeling (
Specific medical conditions, to be identified via initial medical history and examination, which would necessitate exclusion from study participation include: paralytic ileus, coronary artery disease or heart arrhythmia, recent head injury, obstructive sleep apnea, severe asthma or COPD, end-stage renal disease, or severe morbid obesity.
Intervention: Buprenorphine Hydrochloride
Trial phase: Phase 3
SMILES: COC12CCC3(CC1C(C)(O)C(C)(C)C)C1Cc4ccc(O)c5c4C3(CCN1CC1CC1)C2O5.Cl
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Buprenorphine/naloxone via specialist center (B-SC) x 3 months followed by B-PO x 7 months. The specialist center in this trial will be a methadone clinic.

buprenorphine/naloxone: Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
Eligibility criteria:
Inclusion Criteria:

Enrollment in the Drug Treatment Court
diagnosis of opioid dependence using the Addiction Severity Index-Lite and diagnosis by clinical staff of referring units
opioid positive urine drug screen at baseline
women of childbearing potential who have a negative screening urine pregnancy test and are willing to use reliable birth control methods throughout the duration of the study.

Exclusion Criteria:

pregnancy
women who are currently breastfeeding
complex psychiatric co-morbidity (e.g. suicidality, psychosis)
complex medical co-morbidity (e.g. major cardiovascular, renal, or gastrointestinal/hepatic disease)
or current pharmacotherapy with an agent which is contraindicated in combination with buprenorphine/naloxone according to drug labeling (
Specific medical conditions, to be identified via initial medical history and examination, which would necessitate exclusion from study participation include: paralytic ileus, coronary artery disease or heart arrhythmia, recent head injury, obstructive sleep apnea, severe asthma or COPD, end-stage renal disease, or severe morbid obesity.
Intervention: Trimethoprim
Trial phase: Not Applicable
ATC code: J01EA01 | J01EE01 | J01EE02 | J01EE03 | J01EE04 | J01EE05 | J01EE07 | J04AM08
SMILES: COc1cc(Cc2cnc(N)nc2N)cc(OC)c1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.

standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim
Eligibility criteria:
Inclusion Criteria:

Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Have undergone eye surgery including scleral buckling or pneumatic retinopexy for treatment of retinal detachment other condition at the discretion of the investigator.

Exclusion Criteria:

Prior surgery to treat glaucoma.
Current use of glaucoma eye drops.
Absence of a lens in the eye or presence of a lens implant in front of the iris (colored part of your eye).
Allergy or contraindication to any of the glaucoma drops being used in this study (e.g., sulfa allergy, asthma, chronic obstructive pulmonary disease (bronchitis or emphysema), slow heart rate).
Intervention: Vilazodone
Trial phase: Phase 3
ATC code: N06AX24
SMILES: N#Cc1ccc2[nH]cc(CCCCN3CCN(c4ccc5oc(C(N)=O)cc5c4)CC3)c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 202
Group description: Vilazodone tablets, oral administration
Eligibility criteria:
Inclusion Criteria:

Male or female outpatient, 18-70 years of age
Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder
Minimum score of 20 on Hamilton Rating Scale for Anxiety

Exclusion Criteria:

Women who are pregnant or who will be breastfeeding during the study

Patients with a history of:

Any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode
Any depressive episode with psychotic or catatonic features
Panic disorder with or without agoraphobia
Intervention: Morphine
Trial phase: Phase 4
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Group receiving 3mg epidural morphine, 24 hours after the initial dose

Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose.
Eligibility criteria:
Inclusion Criteria:

Women undergoing cesarean section under epidural anesthesia.

Exclusion Criteria:

Emergent cesarean section
Coagulopathy
Failed epidural anesthesia or patchy block
General anesthesia
Use of epidural chloroprocaine
Allergy or contraindication to Non-steroidal anti-inflammatory drug (NSAIDs)
Severe opioid side effects
History of chronic opioid use
History of chronic pain
History of obstructive sleep apnea
Morbid obesity (Body Mass Index (BMI)>45 kg/m2)
Height under 4' 10" (147 cm)
Documented dural puncture by the epidural (Tuohy) needle
Preeclampsia
Other significant medical disease (American Society of Anesthesiologists (ASA) 3 or more).
Intervention: SODIUM CHLORIDE
Trial phase: Phase 4
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.

Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.
Eligibility criteria:
Inclusion Criteria:

Women undergoing cesarean section under epidural anesthesia.

Exclusion Criteria:

Emergent cesarean section
Coagulopathy
Failed epidural anesthesia or patchy block
General anesthesia
Use of epidural chloroprocaine
Allergy or contraindication to Non-steroidal anti-inflammatory drug (NSAIDs)
Severe opioid side effects
History of chronic opioid use
History of chronic pain
History of obstructive sleep apnea
Morbid obesity (Body Mass Index (BMI)>45 kg/m2)
Height under 4' 10" (147 cm)
Documented dural puncture by the epidural (Tuohy) needle
Preeclampsia
Other significant medical disease (American Society of Anesthesiologists (ASA) 3 or more).
Intervention: Cannabidiol
Trial phase: Phase 2
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 50
Group description: 31 subjects were tested with 200 mg CBD and an active marijuana cigarette.
Eligibility criteria:
Inclusion Criteria:

Adults between the ages of 18 and 50.
Current marijuana use: Minimum of four times per week, 0.5 joints per occasion during the preceding 4 weeks.
Able to perform study procedures
Women practicing an effective form of birth control

Exclusion Criteria:

Female subjects who are currently pregnant or breastfeeding.
Current, repeated illicit drug use other than marijuana
Presence of significant medical illness
History of heart disease
Request for drug treatment
Current parole or probation
Recent history of significant violent behavior
Major psychiatric disorder
Intervention: Cannabidiol
Trial phase: Phase 2
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 50
Group description: 31 subjects were tested with 400 mg CBD and an active marijuana cigarette.
Eligibility criteria:
Inclusion Criteria:

Adults between the ages of 18 and 50.
Current marijuana use: Minimum of four times per week, 0.5 joints per occasion during the preceding 4 weeks.
Able to perform study procedures
Women practicing an effective form of birth control

Exclusion Criteria:

Female subjects who are currently pregnant or breastfeeding.
Current, repeated illicit drug use other than marijuana
Presence of significant medical illness
History of heart disease
Request for drug treatment
Current parole or probation
Recent history of significant violent behavior
Major psychiatric disorder
Intervention: Cannabidiol
Trial phase: Phase 2
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 50
Group description: 31 subjects were tested with 800 mg CBD and an active MJ cigarette.
Eligibility criteria:
Inclusion Criteria:

Adults between the ages of 18 and 50.
Current marijuana use: Minimum of four times per week, 0.5 joints per occasion during the preceding 4 weeks.
Able to perform study procedures
Women practicing an effective form of birth control

Exclusion Criteria:

Female subjects who are currently pregnant or breastfeeding.
Current, repeated illicit drug use other than marijuana
Presence of significant medical illness
History of heart disease
Request for drug treatment
Current parole or probation
Recent history of significant violent behavior
Major psychiatric disorder
Intervention: Cannabidiol
Trial phase: Phase 2
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 50
Group description: 31 subjects were tested with 0 mg CBD and an inactive MJ cigarette.
Eligibility criteria:
Inclusion Criteria:

Adults between the ages of 18 and 50.
Current marijuana use: Minimum of four times per week, 0.5 joints per occasion during the preceding 4 weeks.
Able to perform study procedures
Women practicing an effective form of birth control

Exclusion Criteria:

Female subjects who are currently pregnant or breastfeeding.
Current, repeated illicit drug use other than marijuana
Presence of significant medical illness
History of heart disease
Request for drug treatment
Current parole or probation
Recent history of significant violent behavior
Major psychiatric disorder
Intervention: Cannabidiol
Trial phase: Phase 2
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 50
Group description: 31 subjects were tested with 400 mg CBD and an inactive marijuana cigarette.
Eligibility criteria:
Inclusion Criteria:

Adults between the ages of 18 and 50.
Current marijuana use: Minimum of four times per week, 0.5 joints per occasion during the preceding 4 weeks.
Able to perform study procedures
Women practicing an effective form of birth control

Exclusion Criteria:

Female subjects who are currently pregnant or breastfeeding.
Current, repeated illicit drug use other than marijuana
Presence of significant medical illness
History of heart disease
Request for drug treatment
Current parole or probation
Recent history of significant violent behavior
Major psychiatric disorder
Intervention: Cannabidiol
Trial phase: Phase 2
ATC code: N03AX24
SMILES: C=C(C)[C@@H]1CCC(C)=C[C@H]1c1c(O)cc(CCCCC)cc1O
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 50
Group description: 31 subjects were tested with 800 mg CBD and Inactive MJ cigarette.

8 of the 31 study completers were given 800 mg of cannabidiol on one additional study visit to measure plasma concentrations of cannabidiol for up to 360 minutes after ingestion. No MJ cigarette was smoked during this session. Adverse events reported during this session are included here.
Eligibility criteria:
Inclusion Criteria:

Adults between the ages of 18 and 50.
Current marijuana use: Minimum of four times per week, 0.5 joints per occasion during the preceding 4 weeks.
Able to perform study procedures
Women practicing an effective form of birth control

Exclusion Criteria:

Female subjects who are currently pregnant or breastfeeding.
Current, repeated illicit drug use other than marijuana
Presence of significant medical illness
History of heart disease
Request for drug treatment
Current parole or probation
Recent history of significant violent behavior
Major psychiatric disorder