anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Eluxadoline
Trial phase: Phase 2
ATC code: A07DA06
SMILES: COc1ccc(CN(C(=O)[C@@H](N)Cc2c(C)cc(C(N)=O)cc2C)[C@@H](C)c2nc(-c3ccccc3)c[nH]2)cc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 105
Group description: Eluxadoline 5 mg tablets, orally, twice daily for up to 12 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Patient has a diagnosis of IBS by Rome III criteria with a subtype of diarrhea
Female patients must be:
postmenopausal, defined as amenorrhea for at least 2 years at Prescreening,
surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
abstinent, or
if sexually active, be practicing an effective method of birth control.

Key Exclusion Criteria:

Patient has a diagnosis of IBS by Rome III criteria with a subtype of constipation, mixed IBS, or unsubtyped IBS
Patient has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease
Patient has a history of diverticulitis within 6 months prior to Prescreening
Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, impaired intestinal circulation (eg, aortoiliac disease), thrombophlebitis of a major vein, or hypercoagulable states.

Other protocol-specific eligibility criteria may apply.
Intervention: Eluxadoline
Trial phase: Phase 2
ATC code: A07DA06
SMILES: COc1ccc(CN(C(=O)[C@@H](N)Cc2c(C)cc(C(N)=O)cc2C)[C@@H](C)c2nc(-c3ccccc3)c[nH]2)cc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 170
Group description: Eluxadoline 25 mg tablets, orally, twice daily for up to 12 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Patient has a diagnosis of IBS by Rome III criteria with a subtype of diarrhea
Female patients must be:
postmenopausal, defined as amenorrhea for at least 2 years at Prescreening,
surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
abstinent, or
if sexually active, be practicing an effective method of birth control.

Key Exclusion Criteria:

Patient has a diagnosis of IBS by Rome III criteria with a subtype of constipation, mixed IBS, or unsubtyped IBS
Patient has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease
Patient has a history of diverticulitis within 6 months prior to Prescreening
Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, impaired intestinal circulation (eg, aortoiliac disease), thrombophlebitis of a major vein, or hypercoagulable states.

Other protocol-specific eligibility criteria may apply.
Intervention: Eluxadoline
Trial phase: Phase 2
ATC code: A07DA06
SMILES: COc1ccc(CN(C(=O)[C@@H](N)Cc2c(C)cc(C(N)=O)cc2C)[C@@H](C)c2nc(-c3ccccc3)c[nH]2)cc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 165
Group description: Eluxadoline 100 mg tablets, orally, twice daily for up to 12 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Patient has a diagnosis of IBS by Rome III criteria with a subtype of diarrhea
Female patients must be:
postmenopausal, defined as amenorrhea for at least 2 years at Prescreening,
surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
abstinent, or
if sexually active, be practicing an effective method of birth control.

Key Exclusion Criteria:

Patient has a diagnosis of IBS by Rome III criteria with a subtype of constipation, mixed IBS, or unsubtyped IBS
Patient has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease
Patient has a history of diverticulitis within 6 months prior to Prescreening
Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, impaired intestinal circulation (eg, aortoiliac disease), thrombophlebitis of a major vein, or hypercoagulable states.

Other protocol-specific eligibility criteria may apply.
Intervention: Eluxadoline
Trial phase: Phase 2
ATC code: A07DA06
SMILES: COc1ccc(CN(C(=O)[C@@H](N)Cc2c(C)cc(C(N)=O)cc2C)[C@@H](C)c2nc(-c3ccccc3)c[nH]2)cc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 172
Group description: Eluxadoline 200 mg tablets, orally, twice daily for up to 12 weeks.
Eligibility criteria:
Key Inclusion Criteria:

Patient has a diagnosis of IBS by Rome III criteria with a subtype of diarrhea
Female patients must be:
postmenopausal, defined as amenorrhea for at least 2 years at Prescreening,
surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
abstinent, or
if sexually active, be practicing an effective method of birth control.

Key Exclusion Criteria:

Patient has a diagnosis of IBS by Rome III criteria with a subtype of constipation, mixed IBS, or unsubtyped IBS
Patient has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (ie, Crohn's disease, ulcerative colitis) and celiac disease
Patient has a history of diverticulitis within 6 months prior to Prescreening
Patient has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, impaired intestinal circulation (eg, aortoiliac disease), thrombophlebitis of a major vein, or hypercoagulable states.

Other protocol-specific eligibility criteria may apply.
Intervention: Humulin N
Trial phase: Phase 4
ATC code: A10AE01
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)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=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: 75
Group description: Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
Eligibility criteria:
Inclusion Criteria:

Males or females > 60 years of age.
Blood glucose > 150 mg/dl and A1C > 7.5%.
A known history of T2DM, receiving either diet alone, oral monotherapy, or with any combination of oral antidiabetic agents (metformin, sulfonylureas, repaglinide, nateglinide, pioglitazone, rosiglitazone, sitagliptin).
Patients admitted for non-cardiac elective or emergency surgery or trauma.

Exclusion Criteria:

Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state (26).
Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.5 mg/dl).
Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism
Intervention: ALENDRONIC ACID
Trial phase: Not Applicable
ATC code: M05BA04 | M05BB03 | M05BB05 | M05BB06
SMILES: NCCCC(O)(P(=O)(O)O)P(=O)(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
Eligibility criteria:
Inclusion Criteria:

American Spinal Cord Injury Association (ASIA) A or American Spinal Cord Injury Association (ASIA) B Spinal Cord Injury

Exclusion Criteria:

History of hypersensitivity to alendronate or other bisphosphonates
esophageal abnormality
inability to sit/stand upright for 30 minutes
creatinine clearance less than 35 milliliters/minute
hypothyroidism
malignancy
pregnancy
prolonged steroid use
Intervention: Nesiritide
Trial phase: Phase 2
ATC code: C01DX19
SMILES: CCC(C)C1NC(=O)C(CCCNC(=N)N)NC(=O)C(CC(=O)O)NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C(CCCNC(=N)N)NC(=O)CNC(=O)C(Cc2ccccc2)NC(=O)C(NC(=O)CNC(=O)C(CO)NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C2CCCN2C(=O)C(N)CO)C(C)C)CSSCC(C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CC(C)C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc2c[nH]cn2)C(=O)O)C(C)C)NC(=O)CNC(=O)C(CC(C)C)NC(=O)CNC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CO)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 119
Group description: Drug: Nesiritide

Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.

Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial.
Eligibility criteria:
Inclusion Criteria:

A diagnosis of heart failure as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography)
Prior clinical diagnosis of heart failure Must be identified within 24 hours of hospital admission (24 hour clock begins when the admission orders are placed)
Estimated GFR of > 15 but < 60 mL/min/1.73m2 determined by the MDRD equation
Male or female patient ≥18 years old
Willingness to provide informed consent
Ability to have a PICC or central line placed (if needed) within 12 hours of randomization and study drug infusion started
Anticipated hospitalization of at least 72 hours

Exclusion Criteria:

Received IV vasoactive treatment or ultra-filtration therapy for heart failure since initial presentation
Anticipated need for IV vasoactive treatment or ultra-filtration for heart failure during this hospitalization
Systolic BP <90 mmHg
Hemoglobin (Hgb) < 9 g/dl
Renal replacement therapy
History of renal artery stenosis > 50%
Hemodynamically significant arrhythmias including ventricular tachycardia or defibrillator shock within 4 weeks
Acute coronary syndrome within 4 weeks as defined by electrocardiographic (ECG) ST-segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g., troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or anginal equivalent)
Active myocarditis
Hypertrophic obstructive cardiomyopathy
Greater than moderate stenotic valvular disease
Restrictive or constrictive cardiomyopathy
Complex congenital heart disease
Constrictive pericarditis
Non-cardiac pulmonary edema
Clinical evidence of digoxin toxicity
Need for mechanical hemodynamic support
Sepsis
Terminal illness (other than HF) with expected survival of less than 1 year
Previous adverse reaction to the study drugs
Use of IV iodinated radiocontrast material in last 72 hours or planned during hospitalization
Enrollment or planned enrollment in another randomized clinical trial during this hospitalization
Inability to comply with planned study procedures
Pregnancy or nursing mothers
Intervention: Eltrombopag
Trial phase: Phase 2
ATC code: B02BX05
SMILES: CC1=NN(c2ccc(C)c(C)c2)C(=O)/C1=N\Nc1cccc(-c2cccc(C(=O)O)c2)c1O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
Eligibility criteria:
Inclusion Criteria:

Age 16 years or more
Confirmed diagnosis of MYH9-related disease
Average platelet count for the previous year less than 50x10e9/L
Written informed consent

Exclusion Criteria:

Diseases known to involve the risk of thromboembolic events (e.g. atrial fibrillation)
History of thrombosis within 1 year
Use of drugs that affect platelet function (including but not limited to, aspirin, clopidogrel or NSAIDS) or anti-coagulants
Females who are pregnant or nursing (a negative pregnancy test in required before enrollment of fertile women)
Formal refusal of any recommendation of a safe contraception
Alcohol or drug addiction
Altered renal function as defined by creatinine of 20 mg/L or more
Any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioral problems. HCV positivity and liver diseases will not be considered an exclusion criterion since a phase II study showed that eltrombopag was effective and safe in this patient population.
Intervention: Antroquinonol
Trial phase: Phase 1
SMILES: COC1=C(OC)[C@H](O)[C@H](C/C=C(\C)CC/C=C(\C)CCC=C(C)C)[C@@H](C)C1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Safety dose finding from 50mg to 600mg

Antroquinonol : Dosage form: 50 mg and 100 mg capsules

Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)

Frequency: take daily for 4 weeks per subject per dosage level
Eligibility criteria:
Inclusion Criteria:

Age ≥ 20 years.
Diagnosed stage III/IV NSCLC. The grading is determined according to the Tumor-Node-Metastasis (TNM) staging system for lung cancer.
Patients with histologically or cytologically proven primary NSCLC with adenocarcinoma or mixed cell type with adenocarcinoma, who have failed on standard treatments.
With progressive tumor after two lines of chemotherapy (including one platinum-based) and 1 EGFR-targeted therapy if patient is identified with EGFR mutation or his/her EGFR mutation status is unknown OR having refused further currently approved treatment modalities.
Life expectancy ≥ 3 months.
Within 1 week of planned first study treatment day, adequate hematopoietic functions are presented: Total white blood cell (WBC) ≥ 3500 cells/mm3 Hemoglobin (Hb) ≥ 9.0 g/dL Platelets ≥ 100,000 cells/mm3 Absolute neutrophil count (ANC) ≥ 1500 /mm3
Within 1 week of planned first study treatment day, adequate hepatic and renal functions are presented: Total bilirubin ≤2.0 mg/dLGOLANTA20090911, Amendment 4/v. 1.0/ 13 October 2010 AST ≤ 3 × upper limit of normal (ULN); patients with liver metastasis: AST ≤ 5 × ULN ALT ≤ 3 × ULN; patients with liver metastasis: ALT ≤ 5 × ULN Creatinine ≤ 1.5 mg/dL
Must have recovered from toxicities of previous anti-cancer treatments to grade 1 NCI-CTC or better, except for alopecia.
Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2.
Female patient with childbearing potential confirmed of not being pregnant at the screening; and informed that effective contraception must be used during the entire treatment period of this study and for 6 months after exiting from the study.
Given signed and dated written informed consent form.

Exclusion Criteria:

Primary major surgery < 4 weeks prior to the planned first study treatment day.
Lactating, pregnant or plans to be become pregnant.
Except for alopecia, recovered from any previous treatments to a grade 1 or less prior to the planned first study treatment day.
With active systemic infections, active and clinically significant cardiac diseases, active gastrointestinal ulcers, or medical conditions that may significantly affect adequate absorption of investigational product.
Within 5 years, prior history of malignancy other than NSCLC, except cervical carcinoma in situ and basal or squamous cell skin carcinoma.
Known allergic to antroquinonol or its formulation excipients.
Within 14 days of planned first study treatment day, exposed to any drug(s) known to be significant CYP2C19, 3A4, 2C8, and 2E1, inhibitor or activator.
With conditions judged by the investigator as unsuitable for the study.
Intervention: BECLOMETHASONE DIPROPIONATE
Trial phase: Phase 3
ATC code: A07EA07 | D07AC15 | D07CC04 | R01AD01 | R03AK08 | R03AK13 | R03AL09 | R03BA01
SMILES: [H][C@@]12C[C@H](C)[C@](OC(=O)CC)(C(=O)COC(=O)CC)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@@]21C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 236
Group description: During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
Eligibility criteria:
Inclusion Criteria:

Informed Consent
Documented history of perennial allergic rhinitis
A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test.
Minimum subject-reported reflective total nasal symptom score (rTNSS) of at least 6 (out of a possible 12)
Other criteria apply

Exclusion Criteria:

History of physical findings of nasal pathology (within 60 days prior to screening visit)
Participation in any investigational drug study 30 days preceding screening visit
History of respiratory infection/disorder with 14 days preceding screening visit or during the run-in period
Use of any prohibited concomitant medications
Intervention: Sapropterin Dihydrochloride
Trial phase: Not Applicable
SMILES: CC(O)C(O)C1CNc2nc(N)[nH]c(=O)c2N1.Cl.Cl
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: sapropterin dihydrochloride

sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day (week 1-4) 20 mg/kg/day (week 5-8)
Eligibility criteria:
Inclusion Criteria:Inclusion Criteria

Patients with moderate to severe symptoms of diabetic gastroparesis will be studied (GCSI >21). Patients should not have post-surgical gastroparesis or dyspeptic symptoms with normal gastric emptying. In order to qualify for inclusion in the trial, patients must satisfy the following inclusion criteria:

Diagnosis of diabetes mellitus > 5 years requiring medical therapy
Female gender
Ages 18-65 years
Documentation of delayed gastric emptying on gastric emptying scintigraphy (within 2 years of enrollment)
Symptoms of gastroparesis for at least 6 months with Gastroparesis Cardinal Symptom Index (GCSI) score > 21 indicating moderate to severe symptoms
Recent negative upper endoscopy or upper GI series within 2 years of enrollment (no evidence of mechanical obstruction or peptic ulcer disease)

Exclusion Criteria:Exclusion Criteria

Patients who satisfy any of the following exclusion criteria will be ineligible for enrollment in the study:

Diabetes diagnosed < 5 years prior to the study
Male gender
Normal gastric emptying
Gastroparesis from post-surgical etiologies
Another active disorder, which could explain symptoms in the opinion of the investigator
Pregnancy
History of significant cardiac arrhythmias and/or prolonged QTc
Daily use of narcotic analgesics for abdominal pain
Contraindications to gastric emptying breath test: patients with a known allergy to egg, wheat, or algae.
Underlying seizure disorder
Known history of cardiac ischemia
Recent clinically significant gastrointestinal bleeding
Patients taking Levodopa
Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study
Failure to give informed consent
Surgery for placement of a gastric stimulator within the past 6 months (patients > 6 months post-op with persistent symptoms and delayed gastric emptying are eligible).
A normal upper endoscopy not performed within 2 year of study entry.
Patients taking phosphodiesterase inhibitors such as sildenafil, vardenafil, tadalafil
Patients with renal impairment (i.e. Creatinine > 2.5 mg/dL)
Patients with hepatic dysfunction (i.e. ALT and AST values > 2.5x ULN and T. bilirubin > 1.5x ULN)
Patients with uncontrolled diabetes, such as HbA1c > 10 mg/dl at screening/baseline will be excluded.
Intervention: Lansoprazole
Trial phase: Phase 4
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: No
Participants at risk: 506
Group description: Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months.
Eligibility criteria:
Inclusion Criteria:

Had Gastro Esophageal Reflux disease with or without oesophagitis.
Had a history of heartburn at least for 5 days per week during the past 6 months or was receiving long-term treatment with a proton pump inhibitor and during two weeks (without proton pump inhibitor treatment) prior to enrolment.

Exclusion Criteria:

History of surgery of stomach or oesophagus.
Gastric ulcer (can be included after healing of gastric ulcer).
Duodenal ulcer (can be included after healing of duodenal ulcer).
Bleeding (melena, hematemesis).
Severe concomitant disease (cancer, cardiovascular, renal, hepatic diseases).
Barrett oesophagus with dysplasia.
Complicated esophagitis (oesophageal strictures or ulcers).
Treatment with proton pump inhibitor or Histamine receptor 2 (H2)antagonists within the previous two weeks.
Pregnancy, wish to become pregnant, breast feeding.
Treatment with non steroidal anti-inflammatory drugs, treatment with acetylsalicylic acid (aspirin) > 100 mg/day.