anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Zonisamide
Trial phase: Phase 4
ATC code: G01AE10 | N03AX15
SMILES: NS(=O)(=O)Cc1noc2ccccc12
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 121
Group description: Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
Eligibility criteria:
Inclusion criteria:

Epilepsy patient over 15 years old who agrees with Informed Consent Form
Patient who has classifiable uncontrolled partial epilepsy according to International Classification of Epileptic Seizures.
Patient who has 3 ~ dozens of partial seizure (average more than once seizure per 4 weeks) last 12 weeks despite taking 1 ~ 3 antiepileptic drug(s).
Patient who takes 1 ~ 3 marketed antiepileptic drug(s) excluding zonisamide at point of enrollment time.
Before study visit, patient who takes stable dose of antiepileptic drug more than 4 weeks.

Exclusion criteria:

Patient who has progressive central nervous system (CNS) disorder and/or degenerative disease of the brain.
Patient who experiences pseudoseizures and/or who has uncountable clusters.
Patient who has serious systemic or drug metabolism affecting disorder .
Upward of doubled normal glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), bilirubin, blood urea nitrogen (BUN), creatinine levels.
Patient who has absolute neutrophil counts <1800/mm3 or platelets <100,000/mm3.
Patient who has medical history of renal stones.
Patient who is allergic to sulfonamide.
Medical history of medicinal poisoning and/or alcoholism and/or serious psychological disorder.
Pregnant women, lactating women, women of childbearing age who do not use a preventive method of conception.
A terminal patient and/or a scheduled surgical patient.
Patient who has medication history of zonisamide.
Patient who participated other clinical trial within the last 12 weeks at point of enrollment time of this study.
Intervention: Tenofovir
Trial phase: Phase 2
SMILES: C[C@H](Cn1cnc2c(N)ncnc21)OCP(=O)(O)O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 70
Group description: Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.

Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).
Eligibility criteria:
Inclusion Criteria:

Male who has sex with other men (MSM) by self-report
At least 18 years of age
HIV-negative serostatus on baseline rapid oral HIV antibody test, and no signs or symptoms consistent with primary HIV infection (PHI)
Self-reported stimulant use within the previous 30 days
Self-report of unprotected anal intercourse (either receptive or insertive) with an HIV-positive or status unknown partner within the previous 3 months
Self-report of no previous hypersensitivity to any of the components of Truvada (tenofovir disoproxil fumarate or emtricitabine)
In the opinion of the study medical provider, no contraindication to PEP medication treatment (laboratory testing, medical/drug interaction, or other)
Has not used PEP in the previous 6 months
A current resident of Los Angeles County
Does not have a plan to move away from Los Angeles County in the next 6 months
Willing and able to provide informed consent
Willing and able to comply with study requirements

Exclusion Criteria:

Does not identify as a male who has sex with other men
Under 18 years of age
HIV positive by self-report or as indicated by the results on baseline rapid oral HIV antibody testing
Has not used a stimulant in the previous 30 days by self-report
Has not had unprotected anal intercourse (either receptive or insertive) with an HIV-positive or status unknown partner within the previous 3 months
Creatinine clearance <30 ml/min and not on dialysis
Self-reports any previous hypersensitivity to any of the components of Truvada (tenofovir disoproxil fumarate or emtricitabine);
In the opinion of the study medical provider, there exists a contraindication to administering Truvada-based post-exposure prophylaxis (laboratory testing, medical/drug interaction, or other)
Has used PEP in the previous six months
Not a current resident of Los Angeles County
Unwilling or unable to provide informed consent
Unwilling or unable to comply with study requirements
Intervention: Tenofovir
Trial phase: Phase 2
SMILES: C[C@H](Cn1cnc2c(N)ncnc21)OCP(=O)(O)O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 70
Group description: Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.

Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).
Eligibility criteria:
Inclusion Criteria:

Male who has sex with other men (MSM) by self-report
At least 18 years of age
HIV-negative serostatus on baseline rapid oral HIV antibody test, and no signs or symptoms consistent with primary HIV infection (PHI)
Self-reported stimulant use within the previous 30 days
Self-report of unprotected anal intercourse (either receptive or insertive) with an HIV-positive or status unknown partner within the previous 3 months
Self-report of no previous hypersensitivity to any of the components of Truvada (tenofovir disoproxil fumarate or emtricitabine)
In the opinion of the study medical provider, no contraindication to PEP medication treatment (laboratory testing, medical/drug interaction, or other)
Has not used PEP in the previous 6 months
A current resident of Los Angeles County
Does not have a plan to move away from Los Angeles County in the next 6 months
Willing and able to provide informed consent
Willing and able to comply with study requirements

Exclusion Criteria:

Does not identify as a male who has sex with other men
Under 18 years of age
HIV positive by self-report or as indicated by the results on baseline rapid oral HIV antibody testing
Has not used a stimulant in the previous 30 days by self-report
Has not had unprotected anal intercourse (either receptive or insertive) with an HIV-positive or status unknown partner within the previous 3 months
Creatinine clearance <30 ml/min and not on dialysis
Self-reports any previous hypersensitivity to any of the components of Truvada (tenofovir disoproxil fumarate or emtricitabine);
In the opinion of the study medical provider, there exists a contraindication to administering Truvada-based post-exposure prophylaxis (laboratory testing, medical/drug interaction, or other)
Has used PEP in the previous six months
Not a current resident of Los Angeles County
Unwilling or unable to provide informed consent
Unwilling or unable to comply with study requirements
Intervention: Ataluren
Trial phase: Phase 2
ATC code: M09AX03
SMILES: O=C(O)c1cccc(-c2noc(-c3ccccc3F)n2)c1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Cycle 1: Ataluren treatment was taken 3 times per day with meals for 28 days at doses of 5 mg/kg (morning), 5 mg/kg (midday), and 10 mg/kg (evening); there was then an interval of 21 up to 42 days without treatment.

Cycle 2: Ataluren treatment was taken 3 times per day with meals for 28 days at doses of 10 mg/kg (morning), 10 mg/kg (midday), and 20 mg/kg (evening); there was then an interval of 14 days without treatment.
Eligibility criteria:
Major Inclusion Criteria:

Ability to provide written informed consent (parental/guardian consent if applicable)/assent (if applicable)
Age ≥2 years
Phenotypic evidence of methylmalonic acidemia (MMA) based on the presence of characteristic clinical symptoms or signs and an elevated plasma MMacid level (>0.27 micromole/liter (umol/L)
Presence of a nonsense mutation in at least 1 allele of the mutase (mut), Cobalamin A (cblA), or Cobalamin B (cblB) gene
Glomerular filtration rate ≥30 milliliters (mL)/minutes/1.73 meters squared (m^2), serum aminotransferase values ≤2.5*the upper limit of normal, serum bilirubin ≤1.5*the upper limit of normal, plasma adrenocorticotropic (ACTH) within normal limits
Willingness and ability to comply with scheduled visits, drug administration plan, study restrictions, and study procedures

Major Exclusion Criteria:

Known hypersensitivity to any of the ingredients or excipients of the study drug
Any change in chronic treatment for MMA within 2 months prior to start of screening laboratory assessments
Episode of metabolic decompensation within 1 month prior to start of Screening laboratory assessments
History of organ transplantation
Ongoing dialysis for renal dysfunction
Intervention: SODIUM CHLORIDE
Trial phase: Phase 1
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 5
Group description: Saline injection
Eligibility criteria:
Inclusion Criteria:

HIV-1 seropositive with measurable viral load >10e3 copies/ml and CD4+ T-cell count >400 CD4+ cells/µl.
Not in Antiretroviral Therapy (>1 year).
Male or female with age between 18 and 50 years.
Normal values for the area of liver and kidney enzymes, blood cell count with differential counts (e.g. white blood cells, lymphocytes, platelets/thrombocytes) and Hemoglobin
Expected to follow the instructions.
Written informed consent after oral and written information.

Exclusion Criteria:

Vaccinated with other vaccines within 3 months before the first vaccination.
Treated with immune modulating medicine within 3 month before the first immunization.
Other important active chronic infectious diseases likely to influence the HIV-1 infection, like HIV-2, HBV, HCV and TB
Significant medical disease as judged by the investigators, for example severe asthma/COLD, badly regulated heart disease, insulin-dependent diabetes mellitus.
Severe allergy or earlier anaphylactic reactions.
Active autoimmune diseases.
Simultaneous treatment with other experimental drugs.
Laboratory parameters outside the 'normal' range for the area and which are considered clinically significant.
Pregnancy
Intervention: Sorafenib
Trial phase: Not Applicable
ATC code: L01EX02 | L01XE05
SMILES: CNC(=O)c1cc(Oc2ccc(NC(=O)Nc3ccc(Cl)c(C(F)(F)F)c3)cc2)ccn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.

Sorafenib: 400 mg po bid
Eligibility criteria:
Inclusion Criteria:

Patients are candidates to receive both proton beam and sorafenib
Patients with tumor burden that exceeds San Francisco criteria

Exclusion Criteria:

Patients who are candidates for surgical resection
Patients with tumor burden within Milan and/or San Francisco criteria
Patients who have contraindication to receive proton
Patients with contraindication to receive sorafenib including uncontrolled hypertension, coumadin treatment and prior intolerability to the drug
Patients treated previously by any locoregional treatment
Patients with prior liver transplant
Patients with child class C
Patients with model for end-stage liver disease (MELD) score of > 25
Patients with other comorbid diseases that may impact survival
Patients with ongoing alcohol intake
Patients with active sepsis
Patients with gastrointestinal bleeding within a week
Patients unwilling to sign informed consent form
Patients with history of noncompliance
Intervention: Magnesium omeprazole
Trial phase: Phase 1
ATC code: A02BC05
SMILES: COc1ccc2[n-]c(S(=O)Cc3ncc(C)c(OC)c3C)nc2c1.COc1ccc2[n-]c(S(=O)Cc3ncc(C)c(OC)c3C)nc2c1.[Mg+2]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium
Eligibility criteria:
Inclusion Criteria:

Males and females age 18 to 75 years inclusive. Female subjects of child bearing potential or less than two years post-menopausal must use a medically acceptable form of birth control or barrier method and have a negative pregnancy test prior to entry into study.
History of abdominal pain associated with chronic pancreatitis

Evidence of chronic pancreatitis as manifested by an abnormal secretin test, calcification of the pancreas on plain film, an abnormal CT showing a dilated pancreatic duct and/or atrophy, an abnormal Endoscopicretrogradecholangeopancreatography (ERCP), or diffuse changes on Endoscopic Ultrasound (EUS), fecal elastase > 100ug/g stool, or serum trypsinogen > 20ng/ml

-

Exclusion Criteria:

Subjects on enzyme therapy within the last 14 days, proton pump inhibitor (PPI)within the last 7 days, or octreotide within 48 hours.
Subjects with known hypersensitivity to pork or exogenous or pancreatic enzymes.
Female subjects who are pregnant or lactating
Subject use of enzyme therapy other than that called for in this study
Subject use of therapeutic amounts of antacids or H2 receptor antagonists during the course of the study.
Past history of documented steatorrhea by 72 hour fecal fat determination or current history consistent with steatorrhea -
Intervention: Fenofibrate
Trial phase: Phase 1 | Phase 2
ATC code: C10AB05 | C10BA03 | C10BA04 | C10BA09 | C10BA12
SMILES: CC(C)OC(=O)C(C)(C)Oc1ccc(C(=O)c2ccc(Cl)cc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: fenofibrate 160 mg po daily
Eligibility criteria:
Inclusion Criteria:

Male and female patients of 18 to 75 years old
Confirmed diagnosis of PSC including typical findings of stricturing and dilatations of the intra and/or extrahepatic biliary ducts in radiographic exam, (endoscopic retrograde cholangiopancreatography -ERCP, percutaneous cholangiogram - PTC or magnetic resonance cholangiopancreatography- MRCP)
Serum alkaline phosphatase levels elevated to at least 1.5 times the upper limit of normal.

Exclusion Criteria:

Hypersensitivity to fenofibrate
Prisoners and institutionalized subjects
Pregnant or nursing women
Anticipated need for liver transplantation in one year
Recipients of liver transplantation
Recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
Co-existing liver diseases including auto-immune and viral hepatitis
Acute or chronic renal failure, defined as glomerular filtration rate (GFR)< 60 ml/min, GFR calculated using the Modification of Diet in Renal Disease (MDRF) GFR calculator
Known cholecystitis
Current use of statins
Current use of coumadin anticoagulant therapy
Previous history of, or known high risk for, venous thromboembolism,
Intervention: BECLOMETHASONE DIPROPIONATE
Trial phase: Not Applicable
ATC code: A07EA07 | D07AC15 | D07CC04 | R01AD01 | R03AK08 | R03AK13 | R03AL09 | R03BA01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 362
Group description: Patients who meet eligibility criteria will be treated with 6 weeks of beclomethasone dipropionate to assess change in asthma control. This change will be the phenotype used in discovery for the genetic association study. There is no placebo group.

beclomethasone dipropionate: 160 mcg twice a day (320 mcg per day total)
Eligibility criteria:
Inclusion Criteria for Discovery Group:

Age 12-56 years
Physician diagnosis of asthma (identified by using encounter data prior to screening and by the survey administered at the clinic visit)
Bronchodilator reversibility on pulmonary function testing (i.e., improvement in baseline FEV1 of >12%)
African-American/Black self-reported race-ethnicity

Exclusion Criteria for Discovery Group:

Smoking in the preceding year or <10 pack-year smoking history total
Pregnant at the time of enrollment or intending to get pregnant during the 6-week treatment period
Oral or inhaled corticosteroid use in the 4 weeks preceding enrollment
Prior diagnosis of chronic obstructive pulmonary disease or emphysema
Prior diagnosis of congestive heart failure
Self-reported race not African-American/Black or Hispanic ethnicity (these groups could be included in Replication/Validation group)
Intervention: Epinephrine
Trial phase: Phase 1 | Phase 2
ATC code: A01AD01 | B02BC09 | C01CA24 | R01AA14 | R03AA01 | R03AK01 | S01EA01 | S01EA51
SMILES: CNCC(O)c1ccc(O)c(O)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 22
Group description: Active comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose.

epinephrine inhalation aerosol : Single dose 220 mcg/inhalation, 10 inhalations
Eligibility criteria:
Inclusion Criteria:

Generally healthy, male and female adults, 18-30 yrs of age at Screening;
Having no clinically significant respiratory, cardiovascular and other systemic or organic illnesses, per investigator discretion;
Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;
Having properly consented and satisfied all other inclusion/exclusion criteria as required for this protocol.
Other criteria apply.

Exclusion Criteria:

A recent or significant smoking history;
Use of prohibited drugs or failure to observe the drug washout restrictions;
Having been on other investigational drug/device studies in the last 30 days prior to Screening.
Other criteria apply
Intervention: Lurasidone Hydrochloride
Trial phase: Phase 3
SMILES: Cl.O=C1C2C3CCC(C3)C2C(=O)N1CC1CCCCC1CN1CCN(c2nsc3ccccc23)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 148
Group description: Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary.
Eligibility criteria:
Inclusion Criteria:

Subject has completed 6 weeks of treatment and all required assessments on the final study visit (Visit 8) of Study D1050289 (NCT01143077).

Exclusion Criteria:

Subject is considered by the investigator to be at imminent risk of suicide or harm to self, others, or damage to property.
Subject has a body mass index (BMI) greater than 40 or less than 18 kg/m2 (see Appendix 3 for BMI determination).
Intervention: Medroxyprogesterone acetate
Trial phase: Not Applicable
ATC code: G03AA08 | G03AA17 | G03AC06 | G03DA02 | G03FA12 | G03FB06 | L02AB02
SMILES: [H][C@@]12C[C@H](C)C3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@@]1(C)[C@@]2([H])CC[C@]1(OC(C)=O)C(C)=O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 26
Group description: Single injection of Medroxyprogesterone acetate (hormonal contraceptive)

Medroxyprogesterone acetate : Injectable hormonal contraceptive
Eligibility criteria:
Inclusion Criteria:

Age 18-40
negative pregnancy test on day of injection
not wishing to become pregnant in the next 12 months
at negligible risk of pregnancy (e.g. sterilized, in exclusively same-gender partnership, in a monogamous relationship with vasectomized partner, abstinent, using non-hormonal IUD)
body mass index of 18-30

Exclusion Criteria:

-
Intervention: 2-(2-{2-[2-(2-{2-[2-(2-Ethoxy-Ethoxy)-Ethoxy]-Ethoxy}-Ethoxy)-Ethoxy]-Ethoxy}-Ethoxy)-Ethanol, Polyethyleneglycol Peg400
Trial phase: Not Applicable
SMILES: CCOCCOCCOCCOCCOCCOCCOCCOCCO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 136
Group description: Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
Eligibility criteria:
Inclusion Criteria:

Age > 18
Patient scheduled to receive opioid-based postoperative pain management ≥ 48 hrs
Elective colon/rectal resection with anastomosis as primary procedure
Patient enrolled in multidisciplinary colon care process

Exclusion Criteria:

Pregnancy or lactation
Chronic opioid use or > 3 doses in 7 days prior to surgery
History of multiple previous abdominal operations, gastrectomy, bariatric surgery, short bowel syndrome
Complete bowel obstruction
Patients with end-stage renal disease as defined by the need for dialysis and the commonly accepted threshold for dialysis is a Glomerular Filtration Rate of < 15.
Patients with severe hepatic impairment (Childs-Pugh class C)
ASA 4 or 5 (ASA 4 s incapacitating systemic disease that is a constant threat to life)
Non-English speaking patients
Intervention: Alvimopan
Trial phase: Not Applicable
ATC code: A06AH02
SMILES: C[C@H]1CN(C[C@H](Cc2ccccc2)C(=O)NCC(=O)O)CC[C@@]1(C)c1cccc(O)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 138
Group description: Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
Eligibility criteria:
Inclusion Criteria:

Age > 18
Patient scheduled to receive opioid-based postoperative pain management ≥ 48 hrs
Elective colon/rectal resection with anastomosis as primary procedure
Patient enrolled in multidisciplinary colon care process

Exclusion Criteria:

Pregnancy or lactation
Chronic opioid use or > 3 doses in 7 days prior to surgery
History of multiple previous abdominal operations, gastrectomy, bariatric surgery, short bowel syndrome
Complete bowel obstruction
Patients with end-stage renal disease as defined by the need for dialysis and the commonly accepted threshold for dialysis is a Glomerular Filtration Rate of < 15.
Patients with severe hepatic impairment (Childs-Pugh class C)
ASA 4 or 5 (ASA 4 s incapacitating systemic disease that is a constant threat to life)
Non-English speaking patients
Intervention: ALBUTEROL
Trial phase: Not Applicable
ATC code: R03AC02 | R03AK04 | R03AK13 | R03AL02 | R03CC02
SMILES: CC(C)(C)NCC(O)c1ccc(O)c(CO)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 39
Group description: Subjects will perform baseline spirometry. Subsequently subjects will be shown an unmarked metered-dose inhaler device. This inhaler contains active albuterol (90 mcg/puff). The subjects will be reminded that this inhaler may contain either albuterol or placebo, and will complete questionnaires documenting their expectations for improvement in lung function with this treatment. Subsequently subjects will inhale 4 puffs (360 mcg) of albuterol administered from this inhaler via a spacing device.

Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area.
Eligibility criteria:
Inclusion Criteria:

uncontrolled asthma

Exclusion Criteria:

no bronchodilator response