anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Sorafenib
Trial phase: Phase 3
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: 559
Group description: Subjects received 2 tablets of Sorafenib [2*200 milligram (mg)] orally twice daily.
Eligibility criteria:
Inclusion Criteria:

Subjects who have undergone surgical resection or local ablation (PEI or percutaneous or intraoperative RFA) for treatment of HCC with curative intent within 4 months from staging to potentially curative treatment. A maximum of 2 local ablation courses may be administered during this time period.
At least 3 weeks (21 days) but no more than 7 weeks (49 days), from resection or last local ablation course, to CT/MRI scan date
Male or female subjects >/= 18 years of age
Confirmation of CR (absence of residual tumor after curative treatment), on the eligibility scan by independent radiological review.
For subjects undergoing surgical resection pathology proven complete removal of tumor.
Intermediate or High Risk of recurrence as assessed by tumor characteristics.
Child-Pugh score 5 -7 points. A Child-Pugh score of 7 points is allowed only in the absence of ascites.
ECOG Performance Status of 0.
Adequate bone marrow, liver and renal function

Exclusion Criteria:

Recurrent HCC
Child-Pugh score 7 points with presence of ascites.
Low risk of recurrence after curative treatment
History of cardiovascular disease
History of HIV infection
Active clinically serious infections (> grade 2 NCI-CTCAE version 3.0)
Subjects with seizure disorder requiring medication (such as steroids or anti-epileptics)
Subjects with evidence or history of bleeding diathesis
Subjects undergoing renal dialysis
Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry as defined by the signing of informed consent..
Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
Encephalopathy
History of GI bleeding within 30 days of randomization.
Subjects with a history of esophageal varices bleeding which has not been followed by effective therapy and/or treatment to prevent bleeding recurrence.
Prior anti cancer therapy for treatment of HCC (including sorafenib or any other molecular therapy) is excluded.
Major surgery within 4 weeks of start of study as defined by the signing of informed consent, except for surgical resection or local ablation of HCC.
Investigational drug therapy outside of this trial during or within 4 weeks of study entry, as defined by the signing of informed consent.
Liver transplantation, this includes patients on a transplant list with the intention to transplant
Intervention: Omeprazole
Trial phase: Phase 4
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken in the morning
Eligibility criteria:
Inclusion Criteria:

Subjects who have either moderate to severe erosive esophagitis (Los Angeles grade C or D)
Subjects with esophagitis despite use of a non-omeprazole Proton Pump Inhibitor (PPI)(s) or histamine receptor antagonist (HRA) were invited to participate without a wash-out period.
Subjects able to return to Mayo Clinic Rochester for follow up endoscopy 8 weeks after start of study.

Female subjects are eligible if they are not pregnant or lactating and one of the following criteria is met:

Surgically sterile (by means of hysterectomy or bilateral tubal ligation).
At least one year postmenopausal (no menses for greater than or equal to 12 months).
Subject is using a highly effective method of contraception, if of childbearing potential and has a negative urine human chorionic gonadotropin beta subunit (B-HCG) pregnancy test during screening, and prior to trial drug administration.

Exclusion Criteria:

Subjects already on or failed omeprazole in past, or intolerant of PPI therapy
Subjects who are using clopidogrel (Plavix)

Subjects with one or more of the following diagnoses:

Neoplasm of the esophagus or stomach
Previous upper gastrointestinal surgery (esophagectomy, Heller myotomy, hiatal hernial repair)
Diabetic gastroparesis
Esophageal motility disorder: Achalasia or scleroderma
Zollinger-Ellison syndrome
Infection with human immunodeficiency virus (HIV)
Bleeding diathesis
History of gastric or small bowel obstruction
Inability to read due to blindness, cognitive dysfunction, English language illiteracy
Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss
Pregnant and lactating females will be excluded as PPIs are not thought safe for the fetus (Pregnancy Category C).
Children younger than 18 years of age will be excluded as their compliance might be dictated by others, such as their parents, and their results would not be generalizable to the adult population. Other vulnerable populations, such as those with diminished mental acuity, will be excluded for the same reason.
Residence outside of the US (due to difficulties with overseas postal service) or in prison.
Intervention: Omeprazole
Trial phase: Phase 4
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: 8 weeks of therapy with omeprazole/sodium bicarbonate oral suspension 40 mg, once per day, taken at bedtime
Eligibility criteria:
Inclusion Criteria:

Subjects who have either moderate to severe erosive esophagitis (Los Angeles grade C or D)
Subjects with esophagitis despite use of a non-omeprazole Proton Pump Inhibitor (PPI)(s) or histamine receptor antagonist (HRA) were invited to participate without a wash-out period.
Subjects able to return to Mayo Clinic Rochester for follow up endoscopy 8 weeks after start of study.

Female subjects are eligible if they are not pregnant or lactating and one of the following criteria is met:

Surgically sterile (by means of hysterectomy or bilateral tubal ligation).
At least one year postmenopausal (no menses for greater than or equal to 12 months).
Subject is using a highly effective method of contraception, if of childbearing potential and has a negative urine human chorionic gonadotropin beta subunit (B-HCG) pregnancy test during screening, and prior to trial drug administration.

Exclusion Criteria:

Subjects already on or failed omeprazole in past, or intolerant of PPI therapy
Subjects who are using clopidogrel (Plavix)

Subjects with one or more of the following diagnoses:

Neoplasm of the esophagus or stomach
Previous upper gastrointestinal surgery (esophagectomy, Heller myotomy, hiatal hernial repair)
Diabetic gastroparesis
Esophageal motility disorder: Achalasia or scleroderma
Zollinger-Ellison syndrome
Infection with human immunodeficiency virus (HIV)
Bleeding diathesis
History of gastric or small bowel obstruction
Inability to read due to blindness, cognitive dysfunction, English language illiteracy
Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss
Pregnant and lactating females will be excluded as PPIs are not thought safe for the fetus (Pregnancy Category C).
Children younger than 18 years of age will be excluded as their compliance might be dictated by others, such as their parents, and their results would not be generalizable to the adult population. Other vulnerable populations, such as those with diminished mental acuity, will be excluded for the same reason.
Residence outside of the US (due to difficulties with overseas postal service) or in prison.
Intervention: Brimonidine
Trial phase: Phase 2
ATC code: D11AX21 | S01EA05 | S01GA07
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 25
Group description: 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Eligibility criteria:
Inclusion Criteria:

Primary open-angle glaucoma in one eye
Visual acuity 20/80 or better
Intraocular pressure in the study eye ≤ 24 mm Hg
Glaucomatous visual field loss - 7 dB to - 25 dB

Exclusion Criteria:

Known allergy to brimonidine tartrate
Uncontrolled systemic disease or infection of the eye
Recent eye surgery or injections in the eye
Female patients who are pregnant, nursing or planning a pregnancy
Intervention: Brimonidine
Trial phase: Phase 2
ATC code: D11AX21 | S01EA05 | S01GA07
SMILES: Brc1c(NC2=NCCN2)ccc2nccnc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system; Applicator System at Day 1 in study eye.
Eligibility criteria:
Inclusion Criteria:

Primary open-angle glaucoma in one eye
Visual acuity 20/80 or better
Intraocular pressure in the study eye ≤ 24 mm Hg
Glaucomatous visual field loss - 7 dB to - 25 dB

Exclusion Criteria:

Known allergy to brimonidine tartrate
Uncontrolled systemic disease or infection of the eye
Recent eye surgery or injections in the eye
Female patients who are pregnant, nursing or planning a pregnancy
Intervention: Basaglar
Trial phase: Phase 3
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NCC(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Individuals on NPH insuling as long acting insulin.
Eligibility criteria:
Inclusion Criteria:

Written informed consent obtained prior to performing screening evaluations.
Male or female, 18 yrs or older.
Diagnosis of type 1 diabetes made 5 years prior to screening visit.
A1C > 6.0% and 9.0% at screening visit.
Body Mass Index (BMI) 35 kg/m2 at screening visit.
Documented undetectable C-Peptide
Ability to follow instructions for Continuous Glucose Monitoring System (CGMS).
Multiple daily injection participants on at least 3 injections per day. May be treated with NPH or glargine.

Exclusion Criteria:

Pregnant or lactating females, or females planning to become pregnant during the study or not using an acceptable method of contraception. Females of childbearing potential must have a negative pregnancy test at Visit 3 and Visit 5. Females who become pregnant during the study will be discontinued.
Type 2 diabetes.
Two or more severe hypoglycemic episodes (requiring assistance) within six months of Screening.
Drugs known to affect glycemia (eg. steroids, beta blockers) or conditions that are likely to require steroid therapy or cause metabolic instability in the next 6 months.
History of allergy or intolerance to NPH or glargine.
History of hypoglycemia unawareness i.e. no warning symptoms accompanying low (<50 mg/dl) blood glucose levels.
Unable and/or unlikely to comprehend and/or follow the study protocol (including self blood glucose monitoring, CGMS).
Currently using an insulin pump.
Pituitary disorder (Acromegaly, Cushing's, Hypothyroidism etc.) or tumor.
Two or more severe hypoglycemic episodes (requiring assistance) within six months of Screening.
Intervention: Ademetionine
Trial phase: Not Applicable
ATC code: A16AA02
SMILES: C[S+](CC[C@H](N)C(=O)[O-])C[C@H]1O[C@@H](n2cnc3c(N)ncnc32)[C@H](O)[C@@H]1O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 8
Group description: This an open-labeled study. All participants will be part of the treatment group and receive SAM-e.

S-adenosyl methionine : S-adenosyl methionine will be dosed as 200 mg tablets with doses ranging from 200 to 1400 mg daily.
Eligibility criteria:
Inclusion Criteria:

8 to 22 years old
Diagnosed with RAP as verified by a physician, and having at least twice weekly episodes of abdominal pain which cause the patient to withdraw from normal activities.
At least one month trial on a high fiber diet without resolution of abdominal pain.
Ambulatory

Exclusion Criteria:

Focal abdominal pain by history or physical exam, unless a negative (including endoscopic) evaluation has been performed
Current diagnosis of inflammatory bowel disease, pancreatitis (acute or recurrent), peptic ulcer disease, gastrointestinal infection (unresolved), or ongoing gastrointestinal inflammation.
Current or recent (within the past year) pregnancy and/or current breastfeeding.
Current diagnosis of nephropathy or genitourinary disease.
Blood in stools or emesis (EXCEPTION: blood in the stool secondary to hemorrhoids is not an exclusion criterion).
Unintentional loss of over 10% body weight over the past 3 months or weight < 100% ideal body weight.
Recurrent fevers (T>100F) at least once a week or with abdominal pain episodes.
Recurrent dehydration with abdominal pain episodes requiring intravenous rehydration.
Current personal diagnosis of depression or report of suicidality, mania or bipolar disorder.
Family history of mania or bipolar disorder.
Current use of opiates or other prescription pain medications and/or refusal to remain off opiate/prescription pain medications during the study period.
Currently receiving additional therapies besides diet for recurrent abdominal pain and/or refusal to remain off such therapies during the study period, including but not limited to anticholinergic medications, antidepressant medications, biofeedback therapy, cognitive behavioral therapy.
Hypersensitivity to SAM-e.
Inability of child to provide assent and/or inability of parent/custodian to give consent.
Intervention: Erbitux
Trial phase: Phase 2
SMILES: C=C1N(CCCCCC(=O)O)c2ccccc2C1(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Patients received intravenous cetuximab, 400 mg/m2, followed by weekly infusions of 250 mg/m2. Four weekly treatments constituted one cycle.
Eligibility criteria:
Inclusion Criteria:

Pathologically confirmed stage IIIB or IV recurrent or progressive NSCLC
Patients must have progressed while receiving treatment with a tyrosine kinase inhibitor targeting the EGFR pathway
Measurable disease, as defined by RECIST criteria
Patients must have a suitable frozen or paraffin-embedded tissue sample available for EGFR mutational analysis. Prior EGFR mutational analyses are allowable
Patients with asymptomatic brain metastasis are eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and be clinically stable
ECOG Performance Status 0-2
18 years of age or older
Negative pregnancy test within 7 days of treatment or be categorized as not of child-bearing potential
Bone marrow function, renal function, hepatic function as outlined in protocol

Exclusion Criteria:

Women who are pregnant of breastfeeding
Active concurrent malignancy
Major thoracic or abdominal surgery within 30 days prior to the first infusion of cetuximab
Significant history of uncontrolled cardiac disease
Uncontrolled seizure disorder, or active neurological disease
Prior severe infusion reactions to a monoclonal antibody
Prior chemotherapy regimen within 21 days prior to study entry
Any EGFR tyrosine kinase inhibitor within 14 days of study entry
Radiation therapy within 14 days prior to the first infusion of cetuximab
Acute hepatitis or known HIV
Active or uncontrolled infection
Any concurrent chemotherapy or any other investigational agent(s)
Intervention: Risperidone
Trial phase: Phase 2
ATC code: N05AX08
SMILES: Cc1nc2n(c(=O)c1CCN1CCC(c3noc4cc(F)ccc34)CC1)CCCC2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 140
Group description: Participants received risperidone 4.0 mg orally once a day for 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Male or female, 18 to 60 years of age.
Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID).
Total Positive and Negative Syndrome Scale (PANSS) score ≥ 80 and ≤ 120.
Diagnosis of schizophrenia for at least 1 year.

Exclusion Criteria:

Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.
First episode of psychosis.
Intervention: IFN alpha-IFNAR-IN-1
Trial phase: Phase 2
SMILES: CNCc1ccccc1Sc1cccc2ccccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 59
Group description: 500 IU Interferon-alpha lozenge taken once per day plus 2 placebo lozenges per day
Eligibility criteria:
Inclusion Criteria:

HCV genotype 1b
Will be completing pegylated IFN-alpha and ribavirin therapy within 4 weeks
Serum HCV RNA negative within 4 weeks of study entry

Exclusion Criteria:

Child-Pugh score of B or C
Decompensated liver function
History of malignancy within past 5 years
Other causes of liver disease besides HCV infection
Uncontrolled diabetes or hypertension
Unwilling to use two forms of birth control during study treatment
Intervention: IFN alpha-IFNAR-IN-1
Trial phase: Phase 2
SMILES: CNCc1ccccc1Sc1cccc2ccccc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: 500 IU interferon-alpha lozenge taken 3 times per day
Eligibility criteria:
Inclusion Criteria:

HCV genotype 1b
Will be completing pegylated IFN-alpha and ribavirin therapy within 4 weeks
Serum HCV RNA negative within 4 weeks of study entry

Exclusion Criteria:

Child-Pugh score of B or C
Decompensated liver function
History of malignancy within past 5 years
Other causes of liver disease besides HCV infection
Uncontrolled diabetes or hypertension
Unwilling to use two forms of birth control during study treatment
Intervention: Donepezil Hydrochloride
Trial phase: Phase 1 | Phase 2
SMILES: COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2.Cl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 7
Group description: Single group study of Donepezil

Increase REM sleep percentage :

Donepezil hydrochloride :
Eligibility criteria:
INCLUSION CRITERIA:
Diagnosis of autism spectrum disorder
Male or female subjects, ages 2 through 10 years.
Each legal guardian must have a level of understanding sufficient to agree to all required tests and examinations. Each legal guardian must understand the nature of the study.
Each subject must be stable for at least 6 weeks on any medication or therapy regimen prior to entry into study and must have no newly (within 6 weeks) recognized or intolerable adverse effects from that medicine or therapy. No subjects will be asked to discontinue any medication in order to qualify for enrollment.

EXCLUSION CRITERIA:

Serious, unstable illnesses including, gastroenterologic, respiratory, cardiovascular endocrinologic, immunologic,or hematologic disease.
Renal or hepatic dysfunction that would interfere with excretion or metabolism of donepezil as evidenced by increase above upper limits of normal for BUN/creatinine, or two-fold elevation of serum transaminases (ALT/SGPT, AST/SGOT) or gamma glutamate (GGT)
Documented history of hypersensitivity or intolerance to donepezil or other piperidine derivative.
Subjects must not be taking any medication known to affect REM sleep or that is contraindicated for co-administration with donepezil.
Presence or history of neurological disorders, including seizure disorders.
Intervention: Clonidine
Trial phase: Phase 2
ATC code: C02AC01 | C02LC01 | C02LC51 | N02CX02 | S01EA04
SMILES: Clc1cccc(Cl)c1NC1=NCCN1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 90
Group description: Clonidine Topical Gel contains 0.1% clonidine hydrochloride
Eligibility criteria:
Inclusion Criteria:

has Type 1 or Type 2 diabetes mellitus
has a history of chronic pain attributable to a symmetrical stocking distribution neuropathy in the lower extremities for a duration of at least six months but less than or equal to five years prior to Screening

Exclusion Criteria:

has neuropathy secondary to non-diabetic causes
has a significant neurological disorder or a condition that can cause symptoms that mimic peripheral neuropathy or might confound assessment of PDN
has other chronic pain with intensity at or greater than the bilateral pain in the feet/toes
is using an implanted medical device (eg, spinal cord stimulator, intrathecal pump, or peripheral nerve stimulator) for the treatment of pain
is pregnant or lactating
Intervention: Fentanyl Citrate
Trial phase: Phase 3
SMILES: CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1.O=C(O)CC(O)(CC(=O)O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 5
Group description: BEMA Fentanyl

BEMA Fentanyl: buccal soluble film; 200, 400, 600, 800, and 1200 mcg fentanyl; up to 4 times daily
Eligibility criteria:
Inclusion Criteria:

previously qualified for and participated in study FEN-202 for at least 2 weeks,
wish to continue using BEMA Fentanyl for treatment of breakthrough pain episodes, and
provide signed informed consent at screening prior to any study procedures.

Exclusion Criteria:

they have developed a new medical condition after initial enrollment in FEN-202 which, in the opinion of the investigator, would preclude safe and appropriate use of BEMA Fentanyl or participation in this study, or
there is evidence of improper use of the study drug.