anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: MYCOPHENOLATE MOFETIL
Trial phase: Not Applicable
SMILES: COc1c(C)c2c(c(O)c1C/C=C(\C)CCC(=O)OCCN1CCOCC1)C(=O)OC2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 23
Group description: At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.

Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator.
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age and able to give informed consent
African-American ethnicity
Received a first or second non-ECD cadaveric or living donor renal transplant
Transplant occurred during the past 6 to 24 weeks
Patient has stable graft function, defined as no change of greater than 30% of baseline serum creatinine during the past month and no acute rejection in the past 6 weeks
Estimated GFR using the modified MDRD equation of at least 40 mL/min10 at time of enrollment into the study
Currently receiving tacrolimus, mycophenolate mofetil (at least 1 gm per day), and corticosteroids as their immunosuppression regimen.

Exclusion Criteria:

Biopsy proven acute rejection episode that occurred within the past 6 weeks
Malignancy within the past 3 years, except for non-melanoma skin cancer
Any known intolerances to current immunosuppressant regimen necessitating withdrawal of the offending agent
Currently enrolled in an investigational trial
Woman of child bearing potential not utilizing an effective form of birth control
Patients with uncontrolled dyslipidemia, defined at serum fasting LDL >200 mg/dL or serum fasting triglycerides >500 mg/dL.
Patients with a spot urine protein to creatinine ratio of > 800 mg of protein per gram of creatinine.
WBC < 3,000 cells/mm3
Platelets < 100,000 cells/mm3
Intervention: Tacrolimus
Trial phase: Not Applicable
ATC code: D11AH01 | L04AD02
SMILES: C=CCC1C=C(C)CC(C)CC(OC)C2OC(O)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C)=CC3CCC(O)C(OC)C3)C(C)C(O)CC1=O)C(C)CC2OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.

At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age and able to give informed consent
African-American ethnicity
Received a first or second non-ECD cadaveric or living donor renal transplant
Transplant occurred during the past 6 to 24 weeks
Patient has stable graft function, defined as no change of greater than 30% of baseline serum creatinine during the past month and no acute rejection in the past 6 weeks
Estimated GFR using the modified MDRD equation of at least 40 mL/min10 at time of enrollment into the study
Currently receiving tacrolimus, mycophenolate mofetil (at least 1 gm per day), and corticosteroids as their immunosuppression regimen.

Exclusion Criteria:

Biopsy proven acute rejection episode that occurred within the past 6 weeks
Malignancy within the past 3 years, except for non-melanoma skin cancer
Any known intolerances to current immunosuppressant regimen necessitating withdrawal of the offending agent
Currently enrolled in an investigational trial
Woman of child bearing potential not utilizing an effective form of birth control
Patients with uncontrolled dyslipidemia, defined at serum fasting LDL >200 mg/dL or serum fasting triglycerides >500 mg/dL.
Patients with a spot urine protein to creatinine ratio of > 800 mg of protein per gram of creatinine.
WBC < 3,000 cells/mm3
Platelets < 100,000 cells/mm3
Intervention: Omeprazole
Trial phase: Phase 3
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: Accepts Healthy Volunteers
Participants at risk: 60
Group description: Participants receiving Zegerid in Periods 1, 2 or 3.

All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order.
Eligibility criteria:
Inclusion Criteria:

Healthy non-Asian, male or non-lactating, non-pregnant female participants who are 18-65 years of age.
Clinical laboratory test must be within normal limits or clinically acceptable to the Investigator/Sponsor.
Participants must have normal or clinically acceptable physical exam and ECG.
Participants must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations, procedures, or participation.
Able to understand and comply with study procedures required and able and willing to provide written informed consent prior to any study procedures being performed.

Exclusion Criteria:

History of hypersensitivity, allergy or intolerance to omeprazole, or other proton pump inhibitors
History of peptic ulcer disease or other acid related gastrointestinal symptoms or heartburn with a frequency of more than one/month.
Positive H. pylori breath test at screening.
Participation in any study of an investigational treatment in the 30 days before Screening or participation in another study at any time during the period of this study
Any significant medical illness that would contraindicate participation in the study
Gastrointestinal disorder or surgery leading to impaired drug absorption
Any significant mental illness, such as schizophrenia or bipolar disorder
History (in the past year) suggestive of alcohol or drug abuse or dependence, or excessive alcohol use (>2 units per day on average; for example >2 bottles of beer, >2 glasses of wine, >2 ounces of liquor/spirits), or excessive alcohol use during the study
Any abnormal Screening laboratory value that is clinically significant in the investigator's opinion
Currently using or use of any prescription or over the counter (OTC) medications that affect gastrointestinal function, including first generation antihistamines (e.g. diphenhydramine) and anticholinergic agents within 7 days prior to 1st treatment administration.
Currently using, or use within 14 days of first treatment administration, or having a history of frequent use of antacids, OTC or Prescription (Rx) H2 receptor antagonists, or OTC or Rx use of proton pump inhibitors.
Positive urine drug/alcohol test at Screening.
Intervention: Lansoprazole
Trial phase: Phase 3
ATC code: A02BC03 | A02BC06 | A02BC53 | A02BD02 | A02BD03 | A02BD07 | A02BD09 | A02BD10
SMILES: Cc1c(OCC(F)(F)F)ccnc1CS(=O)c1nc2ccccc2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 61
Group description: Participants receiving Prevacid® in Periods 1, 2 or 3.

All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order.
Eligibility criteria:
Inclusion Criteria:

Healthy non-Asian, male or non-lactating, non-pregnant female participants who are 18-65 years of age.
Clinical laboratory test must be within normal limits or clinically acceptable to the Investigator/Sponsor.
Participants must have normal or clinically acceptable physical exam and ECG.
Participants must be free of any clinically significant disease that requires a physician's care and/or would interfere with study evaluations, procedures, or participation.
Able to understand and comply with study procedures required and able and willing to provide written informed consent prior to any study procedures being performed.

Exclusion Criteria:

History of hypersensitivity, allergy or intolerance to omeprazole, or other proton pump inhibitors
History of peptic ulcer disease or other acid related gastrointestinal symptoms or heartburn with a frequency of more than one/month.
Positive H. pylori breath test at screening.
Participation in any study of an investigational treatment in the 30 days before Screening or participation in another study at any time during the period of this study
Any significant medical illness that would contraindicate participation in the study
Gastrointestinal disorder or surgery leading to impaired drug absorption
Any significant mental illness, such as schizophrenia or bipolar disorder
History (in the past year) suggestive of alcohol or drug abuse or dependence, or excessive alcohol use (>2 units per day on average; for example >2 bottles of beer, >2 glasses of wine, >2 ounces of liquor/spirits), or excessive alcohol use during the study
Any abnormal Screening laboratory value that is clinically significant in the investigator's opinion
Currently using or use of any prescription or over the counter (OTC) medications that affect gastrointestinal function, including first generation antihistamines (e.g. diphenhydramine) and anticholinergic agents within 7 days prior to 1st treatment administration.
Currently using, or use within 14 days of first treatment administration, or having a history of frequent use of antacids, OTC or Prescription (Rx) H2 receptor antagonists, or OTC or Rx use of proton pump inhibitors.
Positive urine drug/alcohol test at Screening.
Intervention: Acetylcysteine
Trial phase: Phase 2
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 58
Group description: N-Acetylcysteine: 1200 mg twice daily for 8 weeks

Contingency Management: rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
Eligibility criteria:
Inclusion Criteria:

Age 13-21 years
Regular Marijuana smoker meeting DSM-IV criteria for cannabis dependence and seeking marijuana cessation treatment

Exclusion Criteria:

Allergy or intolerance to NAC
Pregnancy or lactation
Use of carbamazepine or nitroglycerine (or any other drug deemed to be hazardous if taken with NAC) within 14 days of study participation
Current enrollment in treatment for cannabis dependence
Current substance dependence, other than cannabis or nicotine
Significant medical or psychiatric illness that may place the participant at increased risk in the judgement of the study physician
Intervention: Sitagliptin phosphate monohydrate
Trial phase: Not Applicable
SMILES: NC(CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F.O.O=P(O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 3
Group description: Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth

+ pioglitazone (TZD) 15 mg daily by mouth
Eligibility criteria:
Inclusion Criteria:

Impaired glucose tolerance (IGT) by oral glucose tolerance test

Exclusion Criteria:

History of diabetes mellitus
History of congestive heart failure
History of coronary artery disease or other macrovascular disease (stroke, peripheral vascular disease)
History of liver disease (ALT or AST >2.5 times the upper limit of normals)
History of renal disease (serum creatinine >1.5 mg/dl)
History of severe osteoporosis (frequent fractures, failure on osteoporosis treatment)
Current treatment with glucocorticoids
History of immune disorder, including HIV
Women of child-bearing age who are pregnant, desire to become pregnant, are breastfeeding, or who refuse to take the recommended birth control measures
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: 229
Group description: Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
Current treatment: oral anti-diabetic drug(s) (OAD(s)) alone, basal insulin alone or the combination of OAD(s) and basal insulin. Allowed OADs are: Metformin, insulin secretagogues (sulphonylureas (SU) or glinides), pioglitazone with unchanged dosing for at least 3 months prior to Visit 1
HbA1c: OADs only users 7.0-11.0 % (both inclusive), basal insulin with/without OADs users 7.0-10.0% (both inclusive) by central laboratory analysis
Body Mass Index (BMI) below or equal to 40.0 kg/m^2

Exclusion Criteria:

Cancer and medical history of cancer hereof
Use within the last 3 months prior to Visit 1 of: glucagon-like peptide-1(GLP-1) receptor agonist (exenatide, liraglutide), rosiglitazone, dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase-inhibitors
Cardiovascular disease, within the last 6 months prior to Visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
Cancer and medical history of cancer hereof (except basal cell skin cancer and squamous cell skin cancer)
Intervention: Saxagliptin
Trial phase: Phase 4
ATC code: A10BD10 | A10BD21 | A10BD25 | A10BH03
SMILES: N#CC1CC2CC2N1C(=O)C(N)C12CC3CC(CC(O)(C3)C1)C2
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 359
Group description: Saxagliptin 5 mg, oral tablet, once daily
Eligibility criteria:
Inclusion Criteria:

Provision of informed consent prior to any study specific procedures
Established clinical diagnosis of type 2 diabetes. Treatment with a stable metformin monotherapy, for at least 8 weeks prior to Visit 1
HbA1c ≥7.0% and ≤9.0%

Exclusion Criteria:

Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma. Current use of any injectable or oral antihyperglycemic agent excluding metformin.
Renal impairment as defined by a creatinine clearance <60 mL/min
Individuals who, in the opinion of the investigator, in which participation in this study may pose a significant risk to the patient and could render the patient unable to successfully complete the study
Intervention: Glimepiride
Trial phase: Phase 4
ATC code: A10BB12 | A10BD04 | A10BD06
SMILES: CCC1=C(C)CN(C(=O)NCCc2ccc(S(=O)(=O)NC(=O)N[C@H]3CC[C@H](C)CC3)cc2)C1=O
Sex: All
Age groups: Older Adult
Healthy volunteers: No
Participants at risk: 359
Group description: Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
Eligibility criteria:
Inclusion Criteria:

Provision of informed consent prior to any study specific procedures
Established clinical diagnosis of type 2 diabetes. Treatment with a stable metformin monotherapy, for at least 8 weeks prior to Visit 1
HbA1c ≥7.0% and ≤9.0%

Exclusion Criteria:

Type 1 diabetes, history of diabetic ketoacidosis or hyperosmolar non-ketonic coma. Current use of any injectable or oral antihyperglycemic agent excluding metformin.
Renal impairment as defined by a creatinine clearance <60 mL/min
Individuals who, in the opinion of the investigator, in which participation in this study may pose a significant risk to the patient and could render the patient unable to successfully complete the study
Intervention: Elobixibat
Trial phase: Phase 2
ATC code: A06AX09
SMILES: CCCCC1(CCCC)CN(c2ccccc2)c2cc(SC)c(OCC(=O)N[C@@H](C(=O)NCC(=O)O)c3ccccc3)cc2S(=O)(=O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Administered once daily for the duration of the study.
Eligibility criteria:
Inclusion Criteria:

Patient meets protocol specified criteria for constipation
Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests and colonoscopy as applicable

Exclusion Criteria:

Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study
Patient reports loose stools
Patient has IBS with pain/discomfort as predominant symptom
Patient needs medications prohibited as specified in the protocol
Intervention: Elobixibat
Trial phase: Phase 2
ATC code: A06AX09
SMILES: CCCCC1(CCCC)CN(c2ccccc2)c2cc(SC)c(OCC(=O)N[C@@H](C(=O)NCC(=O)O)c3ccccc3)cc2S(=O)(=O)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Administered once daily for the duration of the study
Eligibility criteria:
Inclusion Criteria:

Patient meets protocol specified criteria for constipation
Patient has successfully completed study requirements with no clinically relevant findings for physical exam, ECG, laboratory tests and colonoscopy as applicable

Exclusion Criteria:

Medical history or medical condition that would not make the patient a good candidate for the study or limit the patient´s ability to complete the study
Patient reports loose stools
Patient has IBS with pain/discomfort as predominant symptom
Patient needs medications prohibited as specified in the protocol
Intervention: Calcipotriol plus hydrocortisone
Trial phase: Phase 3
SMILES: C=C1C(=CC=C2CCCC3(C)C2CCC3C(C)C=CC(O)C2CC2)CC(O)CC1O.CC12CCC(=O)C=C1CCC1C2C(O)CC2(C)C1CCC2(O)C(=O)CO
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 27
Group description: LEO 80190: Applied once daily
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of psoriasis vulgaris involving the face
Clinical signs of psoriasis vulgaris on the trunk and/or on the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or limbs. The extent and severity of psoriasis vulgaris on trunk and/or limbs should be amenable to topical therapy with any of the allowed medications
An extent of psoriatic involvement of the face of at least 5 cm2 (the sum of all facial lesions)
Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 30 g (6 to 11 years) or 45 g (12 to 17 years) of ointment per week
Disease severity graded as mild, moderate or severe according to the investigator's global assessment of disease severity of the face
Aged 6 to 17 years

Exclusion Criteria:

Systemic treatment with therapies other than biologicals with a potential effect on psoriasis vulgaris within the 4-week period prior to randomisation
Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation
PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
UVB therapy within the 2-week period prior to randomisation
Topical treatment of psoriasis vulgaris lesions on the face or on the intertriginous areas within the 2-week period prior to randomisation
Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation
Initiation of or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the treatment phase of the study
Current diagnosis of erythrodermic, exfoliative or pustular psoriasis
Intervention: Budesonide
Trial phase: Phase 3
ATC code: A07EA06 | D07AC09 | R01AD05 | R03AK07 | R03AK12 | R03AL11 | R03BA02
SMILES: CCCC1OC2CC3C4CCC5=CC(=O)C=CC5(C)C4C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 134
Group description: Participants who were diagnosed with active mild to moderate UP or UPS, received 2 mg/25 mL of budesonide foam, rectally twice daily for a period of 2 weeks followed by 2 mg/25 mL of budesonide foam, rectally once daily for a period of 4 weeks.
Eligibility criteria:
Inclusion Criteria:

Voluntarily sign written informed consent.
Male or non-pregnant and non-lactating females.
Confirmed diagnosis (by endoscopy procedure) of active, mild to moderate UP or UPS, with disease extending at least 5 centimeters (cm) but no further than 40 cm from the anal verge.
Must possess a baseline Modified Mayo Disease Activity Index (MMDAI) score between 5 and 10.

Exclusion Criteria:

History or current diagnosis of Crohn's disease and indeterminate colitis.
Prior gastrointestinal surgery except appendectomy and hernia.
Concomitant active gastrointestinal disease or distortion of intestinal anatomy.
History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic or known gallbladder disease.
Uncontrolled, previously diagnosed type 1 or 2 diabetes mellitus.
Uncontrolled abnormal thyroid function.
Unstable significant cardiovascular, endocrine, neurologic or pulmonary disease.
Hemoglobin levels less than (<) 7.5 grams /deciliter (g/dL).
History of sclerosing cholangitis, cirrhosis, or hepatic impairment.
Renal disease manifested by greater than (>) 2.0 milligrams/deciliter (mg/dL) serum creatinine.
History of avascular hip necrosis, active tuberculosis, ocular herpes simplex or ocular varicella zoster, malignant disease, and human immunodeficiency virus (HIV) or hepatitis B or C.
Adrenal insufficiency.
Active systemic or cutaneous infection or toxic megacolon, fistula, perforation or abscess.
History of uncontrolled psychiatric disorders or seizure disorders.
History of asthma requiring ongoing use of inhaled steroids.
Recent history of drug or alcohol abuse.
Positive stool test for bacterial pathogens, Clostridium difficile toxin, or ovum and parasites.
Vaccination within 28 days prior to randomization.
Allergies to budesonide or to any other items used in its preparation.
Participation in another clinical trial in the past 30 days.
Pregnant or at risk of pregnancy.
Taking a prohibited medication. Some medications to treat UP/UPS are prohibited during participation in the study, including laxatives and anti-diarrhea medications; however, oral 5-ASA agents at doses up to 4.8 g/day and daily fiber supplements are allowed. Other medications (e.g., antibiotics, anti-seizure and anti-coagulant medicines) are also prohibited.