anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Ambrisentan
Trial phase: Not Applicable
ATC code: C02KX02 | C02KX52
SMILES: COC(c1ccccc1)(c1ccccc1)[C@H](Oc1nc(C)cc(C)n1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients
Eligibility criteria:
Inclusion Criteria:

Subjects should have limited scleroderma with disease duration <7 years and should satisfy American College of Rheumatology criteria for diagnosis.9;

10 Raynaud's phenomenon would be defined as episodic, bilateral, digital color changes (at least 2 out of 3 possible phases:

pallor, cyanosis, rubor),
provoked by cold or emotional stress.
Subjects should be between 18 and 70 years of age and be able to give informed consent.

Exclusion Criteria:

(a) current tobacco users,
(b) advanced cardiopulmonary disease,
(c) clinically unstable patient,
(d) presence of active digital ulcers or prior history of digital ulcers which led to scarring or significant pitting of digits in the area of interest(presence of ulcers or pits would interfere with measurement of blood flow by LDPI),
(e) pregnancy (class X in pregnancy) or unable to use two reliable forms of contraception during the study if patient is of child bearing age,
(f) patients with moderate or severe hepatic impairment
(g) hemoglobin values less than 10% of the lower limit of normal per laboratory standards
(h) inability to discontinue vasodilator treatment including calcium channel blockers, nitrates, alpha blockers, PDE-5 inhibitors, ACE inhibitors and angiotensin receptor blockers at least one week prior to the study,
(i) echocardiographic evidence of pulmonary arterial hypertension [estimated right ventricular systolic pressure <35 mm Hg],
(j) based on section 7.3 of the full prescribing information booklet- patients on cyclosporine, rifampin or ritonavir should be excluded,
(k) patients with diffuse disease,
(l) disease duration > 7 years
Intervention: Prepopik
Trial phase: Phase 3
SMILES: O=C(O)CC(O)(CC(=O)O)C(=O)O.O=S(=O)([O-])Oc1ccc(C(c2ccc(OS(=O)(=O)[O-])cc2)c2ccccn2)cc1.O=[Mg].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 305
Group description: "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
Eligibility criteria:
Inclusion Criteria:

Male or female, age 18 to 80 years, inclusive, being scheduled to undergo elective colonoscopy
Female patients should be post menopausal (women ≥ 45yrs with no menstrual period for at least 12 months without an alternative medical cause), be surgically sterile, or be using medically approved contraception, throughout the trial period
Females of childbearing potential must undergo a pregnancy test at screening and again at randomization
Subjects must have had more than or equal to 3 spontaneous bowel movements per week for one month prior to the colonoscopy
Subjects should be willing, able and competent to complete the entire procedure and to comply with study instructions
Written informed consent obtained prior to study

Exclusion Criteria:

Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery or prior endoscopic procedures
Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo-obstruction, hypomotility syndrome)
Ascites
Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)
Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months, Congestive Heart Failure (CHF), or uncontrolled hypertension
Renal insufficiency (serum creatinine and potassium must be within normal limits)
Participation in an investigational study within 30 days prior to receiving study medication (or within 60 days for investigational drugs with an elimination half-life greater than 15 days)
Any clinically significant laboratory value at the screening, including pre-existing electrolyte abnormality, based on clinical history that the Investigator feels may affect the study evaluation
Hypersensitivity to active ingredients
Intervention: Prepopik
Trial phase: Phase 3
SMILES: O=C(O)CC(O)(CC(=O)O)C(=O)O.O=S(=O)([O-])Oc1ccc(C(c2ccc(OS(=O)(=O)[O-])cc2)c2ccccn2)cc1.O=[Mg].[Na+].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 296
Group description: "Day Before" method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy
Eligibility criteria:
Inclusion Criteria:

Male or female, age 18 to 80 years, inclusive, being scheduled to undergo elective colonoscopy
Female patients should be post menopausal (women ≥ 45yrs with no menstrual period for at least 12 months without an alternative medical cause), be surgically sterile, or be using medically approved contraception, throughout the trial period
Females of childbearing potential must undergo a pregnancy test at screening and again at randomization
Subjects must have had more than or equal to 3 spontaneous bowel movements per week for one month prior to the colonoscopy
Subjects should be willing, able and competent to complete the entire procedure and to comply with study instructions
Written informed consent obtained prior to study

Exclusion Criteria:

Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery or prior endoscopic procedures
Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo-obstruction, hypomotility syndrome)
Ascites
Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)
Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months, Congestive Heart Failure (CHF), or uncontrolled hypertension
Renal insufficiency (serum creatinine and potassium must be within normal limits)
Participation in an investigational study within 30 days prior to receiving study medication (or within 60 days for investigational drugs with an elimination half-life greater than 15 days)
Any clinically significant laboratory value at the screening, including pre-existing electrolyte abnormality, based on clinical history that the Investigator feels may affect the study evaluation
Hypersensitivity to active ingredients
Intervention: Bupivacaine
Trial phase: Not Applicable
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 111
Group description: spinal fentanyl 15 micrograms plus bupivacaine 2.5 mg followed by a patient controlled epidural analgesia (PCEA) maintenance infusion of bupivacaine 1mg/mL

Group 1: A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl.
Eligibility criteria:
Inclusion Criteria:

Age 18 and above
English speaking
Term gestation (> 38 weeks)
Parous parturients presenting for attempted vaginal delivery with a cervical dilation less than 8 cm
They must request neuraxial labor analgesia
Have previously successfully breastfed their child postpartum for at least 6 weeks
Are expressing an interest in exclusively breastfeeding postpartum

Exclusion Criteria:

Under 18 years of age
Parturients who have received parental opioids during labor or have taken opioids prenatally
Patients whose neuraxial analgesia failed due to abnormal spinal anatomy including scoliosis or previous spinal instrumentation
Supplemental epidural opioids during labor
Had an expedited labor with the delivery of the fetus less than 90 minutes from the placement of the neuraxial anesthestic
Underwent cesarean delivery
Received general analgesia for an unanticipated postpartum procedure
Dropout criteria include patients who wished to be taken out of the study or were lost to follow-up
Intervention: Flortanidazole (18F)
Trial phase: Phase 2
SMILES: O=[N+]([O-])c1nccn1Cc1cn(C(CO)CF)nn1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: [F 18]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4
Eligibility criteria:
Inclusion Criteria:

Patient is >18 years and male or female of any race / ethnicity
Patient or patient's legally acceptable representative provides written informed consent and is willing to comply with protocol procedures
Patient must have histopathologically confirmed head/neck, lung, liver, rectal or cervical cancer with tumor size ≥ 3cm
Patient has tumor tissue samples available before treatment for future immunohistochemistry biomarker tests (HIF1alpha and CA-IX)
Patient is scheduled to have or already had a clinical [F 18]FDG PET/CT scan recommended to be within 14 days of the first pre-treatment [F 18]HX4 PET/CT scan and have no treatment intervention in between these two scans
Patient is scheduled or is intended to be scheduled to receive chemotherapy, radiation or chemoradiotherapy treatment(s) after the pre-treatment [F 18]HX4 PET/CT and [F 18]FDG PET/CT scans for his/her cancer care

Patient must have hepatic and renal functions as defined by laboratory results within the following ranges:

Total bilirubin within 2 times institutional upper limit of normal
AST (SGOT) and ALT (SGPT) ≤ 2.5 times institutional upper limits of normal
Serum creatinine ≤ 2.5 times institutional limit of normal
BUN within 2 times institutional upper limit of normal

Exclusion Criteria:

Patient is not capable of complying with study procedures

Female patient is pregnant or nursing

o Exclude the possibility of pregnancy by one of the following:

Confirming in medical history that the patient is post-menopausal for a minimum of one year, or surgically sterile
Confirming the patient is using one of the following methods of birth control for a minimum of one month prior to entry into this study: IUD, oral contraceptives, Depo-Provera, or Norplant
Confirming a negative urine dipstick test taken the morning of but before receiving [F 18]HX4
Patient has been involved in an investigative, radioactive research procedure within 7 days and during the study participation period
Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data
Intervention: Alovudine
Trial phase: Phase 2
SMILES: Cc1cn([C@H]2C[C@H](F)[C@@H](CO)O2)c(=O)[nH]c1=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Receives fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy.

[F18]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)
Eligibility criteria:
Inclusion Criteria:

Ability to understand and willingness to sign a written informed consent document.
Histologically confirmed stage IB2, IIA, IIB, IIIB, and IVA squamous cell carcinoma of the cervix.
Scheduled to receive chemo-radiation for oncologic treatment.
Karnofsky of at least 60 at time of screening
Life expectancy of at least 6 months.
Leukocytes at least 3,000/microL
absolute neutrophil count at least 1,500/microL
platelets at least 100,000/microL
total bilirubin at maximum 1.0 mg/dL (UIHC limit of normal)
either ALT or AST less than 2.5 times the upper limit of normal
creatinine less than 1.5 times the upper limit of normal
non-pregnant, non-nursing, willing to use contraception

Exclusion Criteria:

oncology research protocol requiring full pelvic radiation (i.e., 4-field box technique) or experimental chemotherapy
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
subjects taking nucleoside analog medications such as those used as antiretroviral agents.
patients who have undergone hysterectomy or will have a hysterectomy as part of their cancer therapy.
Intervention: Alovudine
Trial phase: Phase 2
SMILES: Cc1cn([C@H]2C[C@H](F)[C@@H](CO)O2)c(=O)[nH]c1=O
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Receives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy.

[F18]Fluorothymidine: FLT PET scan 5 mCi (+/- 10%)
Eligibility criteria:
Inclusion Criteria:

Ability to understand and willingness to sign a written informed consent document.
Histologically confirmed stage IB2, IIA, IIB, IIIB, and IVA squamous cell carcinoma of the cervix.
Scheduled to receive chemo-radiation for oncologic treatment.
Karnofsky of at least 60 at time of screening
Life expectancy of at least 6 months.
Leukocytes at least 3,000/microL
absolute neutrophil count at least 1,500/microL
platelets at least 100,000/microL
total bilirubin at maximum 1.0 mg/dL (UIHC limit of normal)
either ALT or AST less than 2.5 times the upper limit of normal
creatinine less than 1.5 times the upper limit of normal
non-pregnant, non-nursing, willing to use contraception

Exclusion Criteria:

oncology research protocol requiring full pelvic radiation (i.e., 4-field box technique) or experimental chemotherapy
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
subjects taking nucleoside analog medications such as those used as antiretroviral agents.
patients who have undergone hysterectomy or will have a hysterectomy as part of their cancer therapy.
Intervention: Sitagliptin
Trial phase: Phase 3
ATC code: A10BD07 | A10BD12 | A10BD24 | A10BH01 | A10BH51
SMILES: N[C@@H](CC(=O)N1CCn2c(nnc2C(F)(F)F)C1)Cc1cc(F)c(F)cc1F
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 120
Group description: Sitagliptin 100 mg once daily
Eligibility criteria:
Inclusion Criteria:

has type 2 diabetes mellitus
is male, a female who cannot have children, or a female who agrees to use birth control during the study
is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7.5-11.0%) or on oral single AHA (A1C 7.0-10.5%) or low-dose AHA combination therapy (A1C 7.0-10.0%)

Exclusion Criteria:

Patient has type 1 diabetes mellitus or ketoacidosis
Patient is taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin)
Patient is on a weight loss program not in the maintenance phase or on a weight loss medication
Patient has a history of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
Patient is HIV positive
Patient is pregnant
Intervention: Baclofen
Trial phase: Phase 2
ATC code: M03BX01
SMILES: NCC(CC(=O)O)c1ccc(Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
Eligibility criteria:
Inclusion Criteria:

must be male or female between 21 and 65 years old (inclusive).
participants must meet criteria for current Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR) diagnosis of alcohol dependence, supported by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders Patient Edition (SCID-I/P).
participants must meet criteria for heavy drinking, defined as averaging ≥4 drinks/day for women and ≥5 drinks/day for men during a consecutive 30-day period within the 90 days prior to baseline evaluation (see: Anton et al, 2006). The gender-specific baseline was chosen as it represents heavy drinking that exceeds empirically based levels of moderate alcohol use that result in alcohol-related problems for women who consume ≥4 drinks/day, and men who consume ≥5 drinks/day (Sanchez-Craig et al, 1995).
participants must be in good health as confirmed by medical history, physical examination, ECG, lab tests.
females must be postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control before entry and throughout the study; have a negative urine pregnancy test at each visit.
participants must be willing to take oral medication and adhere to the study procedures.

Exclusion criteria:

individuals expressing interest in treatment for alcoholism.
pregnancy or breast feeding women or not using an adequate form of birth control
positive urine drug screen at baseline for any illegal substance (a urine drug screen may be repeated once during the screening period).
individuals diagnosed with a current substance dependence diagnosis, other than alcohol or nicotine.
meet DSM-IV Axis I criteria for a lifetime diagnosis of schizophrenia, bipolar disorder, or other psychoses.
an active illness within the past 6 months of Visit 1 that meet the DSM-IV criteria for a diagnosis of Major Depressive Disorder (MDD) or Anxiety Disorder. Subjects with a history of suicide will be excluded.
clinically significant medical abnormalities (i.e., unstable hypertension, ECG, bilirubin > 150% of the upper normal limit, ALT or AST elevations >300% the upper normal limit, creatinine clearance ≤ 60 dl/min).
current use of psychotropic medications that cannot be discontinued that may have an effect on alcohol consumption or that may interact with baclofen or cyproheptadine.
medical contraindications for use of baclofen or cyproheptadine.
a history of adverse reaction or hypersensitivity to baclofen or cyproheptadine.
individuals with a reasonable expectation of being institutionalized during the course of the trial.
participants who have significant alcohol withdrawal symptoms, defined as a Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) >10.
history of seizures (e.g. epilepsy).
subjects who have participated in any behavioral and/or pharmacological study within the past 90 days.
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: 234
Group description: Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes (diagnosed clinically) for at least 6 months
Insulin naïve subjects (allowed are: previous short term insulin treatment up to 14 days; treatment during hospitalisation or during gestational diabetes is allowed for periods longer than 14 days)
Current treatment: metformin monotherapy or metformin in any combination with insulin secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor, alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least 3 months prior to visit 1 with the minimum doses stated: -Metformin: alone or in combination (including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000 mg daily)-Insulin secretagogue (sulfonylurea (SU) or glinide): minimum half of the daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the daily maximal dose according to local labelling -alpha-glucosidase-inhibitor (acarbose): minimum half of the daily maximal dose or maximum tolerated dose
HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
BMI (Body Mass Index) below or equal to 45.0 kg/m^2

Exclusion Criteria:

Use within the last 3 months prior to Visit 1 of: Thiazoledinediones (TZDs), Exenatide or Liraglutide
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 or squamous cell skin cancer)
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: 30
Group description: 20 mg omeprazole and 1100 mg sodium bicarbonate
Eligibility criteria:
Inclusion Criteria:

Male or non-lactating, non-pregnant female subjects who are 18-65 years of age.
Physical examination findings within normal limits for age.

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.
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 abnormal Screening laboratory value that is clinically significant in the investigator's opinion
Current use of any prescription or OTC medications that affect gastrointestinal function.
Currently using or having a history of frequent use of antacids, OTC or prescription (Rx) histamine-2 (H2) receptor antagonists, or OTC or Rx use of proton pump inhibitors.