anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
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: 30
Group description: Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.

Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months
Eligibility criteria:
Patients who have undergone ablation for Barrett's Esophagus (BE) and High Grade Dysplasia (HGD) or Low Grade Dysplasia (LGD) with Photodynamic Therapy (PDT)/Radiofrequency ablation and endoscopic mucosal resection who have no endoscopic and histologic evidence of specialized intestinal metaplasia on biopsies from the esophagus on two successive endoscopies post ablation will be offered enrollment in the study.

Inclusion criteria:

Absence of intestinal metaplasia on endoscopy (under Narrow Band Imaging) and on histology (from biopsies taken from gastroesophageal junction and distal esophagus) on two successive surveillance endoscopies.
Able to consent to study
Males and females age 18-90
Life expectancy of 5 years or greater.

Exclusion criteria:

Pregnancy
Inability to consent for the procedure
Anticoagulation therapy precluding performance of ambulatory pH monitoring and/or biopsies
Intolerance to proton pump inhibitors
Elevation in Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), (liver enzymes), bilirubin or alkaline phosphatase more than five times the upper limit of normal.
Intervention: Dronabinol
Trial phase: Phase 2
ATC code: A04AD10
SMILES: [H][C@@]12C=C(C)CC[C@@]1([H])C(C)(C)Oc1cc(CCCCC)cc(O)c12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 14
Group description: Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks
Eligibility criteria:
Inclusion Criteria:

Age 18-65 years
Obsessive-compulsive disorder (OCD), Trichotillomania (TTM), or Pathological Skin Picking (PSP) as the primary psychiatric diagnosis
(If OCD) - Subject reports ≥two failed treatments using selective serotonin reuptake inhibitors (SSRIs) for their OCD
Women's participation required negative results on a beta-human chorionic gonadotropin pregnancy test and stable use of a medically accepted form of contraception.
Signed informed consent before entry into the study.

Exclusion Criteria:

Unstable medical illness or clinically significant abnormalities on laboratory tests or physical examination at screening visit
Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
A need for medication other than dronabinol with possible psychotropic effects
History of hypersensitivity to any cannabinoid or sesame oil
Lifetime history of bipolar disorder type I or II, dementia, or schizophrenia as determined by the Structured Clinical Interview for DSM-IV
Current (past 12-months) DSM-IV substance abuse or dependence
Positive urine drug screen at screening
Initiation of cognitive behavior therapy within 3 months prior to study baseline
Baseline score of ≥ 17 on the Hamilton Depression Rating Scale (17-item HDRS
Suicidality based on clinical interview
History of head injury or neurological disorder (such as seizures)
Intervention: Morphine
Trial phase: Phase 1 | Phase 2
ATC code: A07DA52 | N02AA01 | N02AA51 | N02AG01
SMILES: [H][C@@]12C=C[C@H](O)[C@]3([H])Oc4c(O)ccc5c4[C@]13CCN(C)[C@]2([H])C5
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 20
Group description: One half the Study patients will be randomized to receive a loading dose of IV morphine, followed by IV doses (given by the ICU nurse), on a PRN basis, for pain control for up to 24 hours during their postoperative course while they are intubated.

Morphine: 0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN ("as needed") doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain.
Eligibility criteria:
Inclusion Criteria:

Neonates, infants and children from birth through 5 years of age undergoing mechanical ventilation following cardiac surgery for congenital heart disease. Congenital heart lesions include "two ventricle repairs", including tetralogy of Fallot, transposition of the great arteries, "unobstructed" total anomalous pulmonary venous return, truncus arteriosus, atrioventricular canal defect and ventricular septal defect.

Exclusion Criteria:

Subjects will be excluded from the study because of prematurity (gestational age < 37 weeks), weight < 3.0 kg, severe hepatic dysfunction (elevation of conjugated bilirubin > 2, AST/ALT > 200 IU/L), significant renal dysfunction (serum Cr > 1.5 mg/dL), participation within 30 days of study entry or within 5 times the half-life, whichever is longer, in another investigational drug study, or previous participation in this study. Patients will be excluded if they have received opioids for more than 12 hours of the 48-hour period prior to surgery. In addition, patients will be excluded if they have a history of other clinically significant medical problems, which, in the opinion of the investigator, would interfere with study participation.
Intervention: Synthetic human secretin
Trial phase: Not Applicable
SMILES: CC(C)CC(NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(CC(C)C)NC(=O)C(CC(C)C)NC(=O)C(CCCNC(=N)N)NC(=O)C(CCC(N)=O)NC(=O)C(CC(C)C)NC(=O)C(CCCNC(=N)N)NC(=O)C(C)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CCCNC(=N)N)NC(=O)C(CC(C)C)NC(=O)C(CCCNC(=N)N)NC(=O)C(CO)NC(=O)C(CC(C)C)NC(=O)C(CCC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(=O)NC(C(N)=O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Single arm (open label).

Synthetic Human Secretin: Twenty five patients will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.
Eligibility criteria:
Inclusion Criteria:

18 years of age and older.
At least two first or two second degree relatives with pancreatic adenocarcinoma (the study subject will be either 10 years younger than the youngest age at which a relative was diagnosed with pancreatic cancer, or the study subject will be at least 25 years of age).
Fulfills criteria or has undergone genetic testing which confirms BRCA1 (BReast CAncer gene 1), BRCA2 (BReast CAncer gene 2), Familial Atypical Multiple Mole Melanoma, PeutzJeghers, Hereditary nonpolyposis colorectal cancer (HNPCC), Hereditary Pancreatitis, or ataxiatelangiectasia.

Exclusion Criteria:

Any contraindication to MRI, including but not limited to implanted metal devices (e.g. pacemaker,berry aneurysm clips, neural stimulator or cochlear implants).
Known pancreatic malignancy or dysplasia.
Pregnancy.
History of sensitivity to secretin.
Creatinine greater than 2.
Unwillingness or inability to provide informed consent.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 1
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
Eligibility criteria:
Inclusion Criteria:

Gender: Male or female (non-pregnant, non-lactating)
Cystic fibrosis documented by a compatible clinical and radiographic presentation, and sweat chloride > 60 mEq/l or 2 disease causing CFTR mutations.

Severity of Disease:

Must have FEV1 of greater than or equal to 50% of predicted at the screening visit.
Must have an oxygen saturation of >92% on room air as determined by pulse oximetry at the screening visit.
Patient or legally authorized representative agrees to the patient/individual's participation in the study by signing and dating the informed consent form after the nature of the study has been fully explained and all questions have been satisfactorily answered.

Exclusion Criteria:

Unstable lung disease: As defined by a change in medical regimen during the preceding 2 weeks; an FEV1 >15% below recent (within 6 months) clinical measurements; or a significant new finding on chest radiograph (pneumothorax, lobar/segmental collapse) not considered a part of the usual, chronic progression of CF lung disease.
Patients unable or unwilling to be withdrawn from hypertonic saline therapy, dornase alfa, or N-acetylcysteine 3 days prior to and for the duration of each Baseline and Treatment Period will be excluded.
Patients unable to withhold use of long-acting bronchodilators (i.e., Salmeterol, Advair, Formoterol), anti-cholinergics, and vest therapy 12 hours prior to and for the duration of each treatment period.
Patients unable to withhold short-acting bronchodilator 6 hours prior to and for the duration of each treatment period except as prescribed by the study protocol.
Patients that have received an investigational drug or therapy during the preceding 30 days.
Patients that have had radiation exposure within the past year that would cause them to exceed Federal Regulations by participating in this study.
Intervention: SODIUM CHLORIDE
Trial phase: Phase 1
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
Eligibility criteria:
Inclusion Criteria:

Gender: Male or female (non-pregnant, non-lactating)
Cystic fibrosis documented by a compatible clinical and radiographic presentation, and sweat chloride > 60 mEq/l or 2 disease causing CFTR mutations.

Severity of Disease:

Must have FEV1 of greater than or equal to 50% of predicted at the screening visit.
Must have an oxygen saturation of >92% on room air as determined by pulse oximetry at the screening visit.
Patient or legally authorized representative agrees to the patient/individual's participation in the study by signing and dating the informed consent form after the nature of the study has been fully explained and all questions have been satisfactorily answered.

Exclusion Criteria:

Unstable lung disease: As defined by a change in medical regimen during the preceding 2 weeks; an FEV1 >15% below recent (within 6 months) clinical measurements; or a significant new finding on chest radiograph (pneumothorax, lobar/segmental collapse) not considered a part of the usual, chronic progression of CF lung disease.
Patients unable or unwilling to be withdrawn from hypertonic saline therapy, dornase alfa, or N-acetylcysteine 3 days prior to and for the duration of each Baseline and Treatment Period will be excluded.
Patients unable to withhold use of long-acting bronchodilators (i.e., Salmeterol, Advair, Formoterol), anti-cholinergics, and vest therapy 12 hours prior to and for the duration of each treatment period.
Patients unable to withhold short-acting bronchodilator 6 hours prior to and for the duration of each treatment period except as prescribed by the study protocol.
Patients that have received an investigational drug or therapy during the preceding 30 days.
Patients that have had radiation exposure within the past year that would cause them to exceed Federal Regulations by participating in this study.
Intervention: Lubiprostone
Trial phase: Phase 4
ATC code: A06AX03
SMILES: [H][C@@]12CC(=O)[C@H](CCCCCCC(=O)O)[C@@]1([H])CC[C@](O)(C(F)(F)CCCC)O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 23
Group description: Active medication

lubiprostone: 24mcg BID, capsule, oral 30days
Eligibility criteria:
Inclusion Criteria:

Adult male or female outpatient age 19 or older.

Patients meet International Congress of Gastroenterology (ROME III) clinical criteria for constipation*:

Must include two or more of the following:

Straining in > 1/4 defecations;
Lumpy or hard stools > 1/4 defecations;
Sensation of incomplete evacuation in 1/4 defecations;
Sensation of anorectal obstruction/blockage in > 1/4 defecations;
<3 defecations/week.
Loose stools are rarely present without the use of laxatives.
There are insufficient criteria for irritable bowel syndrome. *Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
Use of one or more of listed medications known to cause constipation.
If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study. Mandatory compliance is required. Serum pregnancy tests will be performed at screening and during needed follow-up. Negative results will be received before inclusion and administration of first study dose. If pregnancy occurs during the trial, the investigator is notified immediately resulting in prompt discontinuation.
Study subjects must not have received lubiprostone for more than 72 hours.
Written informed consent.

Exclusion Criteria:

Known or suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.
Severe diarrhea.
Prior small bowel or colonic resection or colostomy.
Weight < 80 lbs.
If the patient has constipation that according to the investigator's clinical judgment is not the result of constipating medications but is suffering from a secondary cause including but limited to factors that are dietary, neurologic, congenital, diabetic or hypothyroid.
Positive stool hemoccult (Can be included if colonoscopic evaluation is subsequently negative).
Significant cardiac, renal or hepatic insufficiency.
Pregnant or expecting to become pregnant within 120 days of study enrollment.
Lactating or breast feeding.
Subjects using opioid medications.
Subjects who in the opinion of the investigator would be unable to comply adequately with the study plan.
Use of investigational drugs in the last 30 days.
Patients with known allergy to lubiprostone.
Intervention: Lisdexamfetamine Dimesylate
Trial phase: Phase 2
SMILES: CC(Cc1ccccc1)NC(=O)C(N)CCCCN.CS(=O)(=O)O.CS(=O)(=O)O
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
Eligibility criteria:
Inclusion Criteria:

Male subjects between the ages of 18-40 years.
The subject is in good health and must have a satisfactory medical assessment with no clinically significant and relevant abnormalities (of medical history, physical examination, electrocardiogram (ECG), clinical laboratory evaluation (hematology, biochemistry, and urinalysis).
Subject has a history of regular sleep-wake habits, routinely spending 6.5-8 hours in bed nightly, and does not oversleep by more than 3 hours on weekends.
Subject has the ability to provide written, signed, and dated (personally) informed consent to participate in the study, in accordance with the International Conference on Harmonisation Good Clinical Practice Guideline E6 and applicable regulations, before completing any study-related procedures.

Exclusion Criteria:

Current or relevant previous history of serious, severe, or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make this subject unlikely to fully complete the study, or any condition that presents undue risk from SPD489 or armodafinil or procedures. Comorbid psychiatric diagnosis will be established by a psychiatric evaluation that includes the Mini International Neuropsychiatric Interview (MINI)-Plus.
Subject is currently considered a suicide risk, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating suicidal ideation.
Subject has a known or suspected sleep disorder, or another disorder associated with excessive daytime sleepiness, or any other diagnosis that would interfere with assessing sleepiness in subjects with study related induced sleepiness or abnormal findings on the initial PSG conducted on Day -1 such as, but not limited to, Apnea-Hypopnea Index (AHI) or Periodic Limb Movement Arousal Index (PLMAI) >10.
Intervention: Lisdexamfetamine Dimesylate
Trial phase: Phase 2
SMILES: CC(Cc1ccccc1)NC(=O)C(N)CCCCN.CS(=O)(=O)O.CS(=O)(=O)O
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
Eligibility criteria:
Inclusion Criteria:

Male subjects between the ages of 18-40 years.
The subject is in good health and must have a satisfactory medical assessment with no clinically significant and relevant abnormalities (of medical history, physical examination, electrocardiogram (ECG), clinical laboratory evaluation (hematology, biochemistry, and urinalysis).
Subject has a history of regular sleep-wake habits, routinely spending 6.5-8 hours in bed nightly, and does not oversleep by more than 3 hours on weekends.
Subject has the ability to provide written, signed, and dated (personally) informed consent to participate in the study, in accordance with the International Conference on Harmonisation Good Clinical Practice Guideline E6 and applicable regulations, before completing any study-related procedures.

Exclusion Criteria:

Current or relevant previous history of serious, severe, or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make this subject unlikely to fully complete the study, or any condition that presents undue risk from SPD489 or armodafinil or procedures. Comorbid psychiatric diagnosis will be established by a psychiatric evaluation that includes the Mini International Neuropsychiatric Interview (MINI)-Plus.
Subject is currently considered a suicide risk, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating suicidal ideation.
Subject has a known or suspected sleep disorder, or another disorder associated with excessive daytime sleepiness, or any other diagnosis that would interfere with assessing sleepiness in subjects with study related induced sleepiness or abnormal findings on the initial PSG conducted on Day -1 such as, but not limited to, Apnea-Hypopnea Index (AHI) or Periodic Limb Movement Arousal Index (PLMAI) >10.
Intervention: Lisdexamfetamine Dimesylate
Trial phase: Phase 2
SMILES: CC(Cc1ccccc1)NC(=O)C(N)CCCCN.CS(=O)(=O)O.CS(=O)(=O)O
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 27
Group description: A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
Eligibility criteria:
Inclusion Criteria:

Male subjects between the ages of 18-40 years.
The subject is in good health and must have a satisfactory medical assessment with no clinically significant and relevant abnormalities (of medical history, physical examination, electrocardiogram (ECG), clinical laboratory evaluation (hematology, biochemistry, and urinalysis).
Subject has a history of regular sleep-wake habits, routinely spending 6.5-8 hours in bed nightly, and does not oversleep by more than 3 hours on weekends.
Subject has the ability to provide written, signed, and dated (personally) informed consent to participate in the study, in accordance with the International Conference on Harmonisation Good Clinical Practice Guideline E6 and applicable regulations, before completing any study-related procedures.

Exclusion Criteria:

Current or relevant previous history of serious, severe, or unstable (acute or progressive) physical or psychiatric illness, any medical disorder that may require treatment or make this subject unlikely to fully complete the study, or any condition that presents undue risk from SPD489 or armodafinil or procedures. Comorbid psychiatric diagnosis will be established by a psychiatric evaluation that includes the Mini International Neuropsychiatric Interview (MINI)-Plus.
Subject is currently considered a suicide risk, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating suicidal ideation.
Subject has a known or suspected sleep disorder, or another disorder associated with excessive daytime sleepiness, or any other diagnosis that would interfere with assessing sleepiness in subjects with study related induced sleepiness or abnormal findings on the initial PSG conducted on Day -1 such as, but not limited to, Apnea-Hypopnea Index (AHI) or Periodic Limb Movement Arousal Index (PLMAI) >10.
Intervention: Atorvastatin
Trial phase: Phase 4
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Hydroxymethylglutaryl-CoA Reductase Inhibitors

Atorvastatin : 40mg/day once daily for two weeks prior to surgery
Eligibility criteria:
Inclusion Criteria:

Patients undergoing elective isolated coronary artery bypass surgery with on-pump technique
Written informed consent

Exclusion Criteria:

Concomitant valve or aortic surgery
Left ventricular aneurysm repair
Re-operation
Emergency surgery
History of myocardial infarction within less than 4 weeks
Hepatic impairment
Chronic renal impairment
Drug related side effects (allergy or hypersensitivity)
Familial Hyperlipidemia
Autoimmune conditions which require steroids