anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Estradiol
Trial phase: Phase 4
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 41
Group description: Group B received the transdermal estradiol for 12 months
Eligibility criteria:
Inclusion Criteria:

Girls with Turner Syndrome (45X, or related karyotypes) diagnosed clinically and cytogenetically
Female subjects with Y material will be allowed providing gonadectomies have been performed previously
Age: 13-20 years
Subjects have completed or nearly completed their linear growth
Previous growth hormone (GH) therapy discontinued at least 6 months prior to study participation
Stable thyroid replacement therapy will be allowed
Celiac disease on stable diets will be allowed
Any previous hormone replacement therapy (HRT) will be allowed

Exclusion Criteria:

Diabetes Mellitus on insulin therapy, insulin sensitizers or oral hypoglycemics
Inflammatory Bowel Disease (ulcerative colitis or Crohn's disease), celiac disease
Cigarette smoking
Any other chronic conditions, that, in the opinion of investigators could impair the metabolism of nutrients
Severe obesity, i.e., Body Mass Index (BMI) >95th centile
Intervention: Phenylephrine
Trial phase: Not Applicable
ATC code: C01CA06 | R01AA04 | R01AB01 | R01BA03 | R01BA53 | S01FB01 | S01FB51 | S01GA05 | S01GA55
SMILES: CNC[C@H](O)c1cccc(O)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 106
Group description: Participants who were of African American descent.
Eligibility criteria:
Inclusion Criteria:

Age between 18 and 40 years, inclusive.
Subject must be willing to give written informed consent and be able to adhere to diet and study schedules.
Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with the study evaluations.
Subjects must have a normal or clinically acceptable physical examination and ECG.
Clinical laboratory tests (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator.

Exclusion Criteria:

Any subject who has taken any prescription or over-the-counter drugs, other than oral contraception if female, within two weeks prior to study drug administration.
Subjects who are presently, or were formerly, narcotic addicts or alcoholics.
Subjects who have a clinically significant allergy/intolerance to phenylephrine.
Females with a positive serum/urine pregnancy test at screening.
Females who are nursing.
Subject using sildenafil or other phosphodiesterase inhibitors.
Intervention: Phenylephrine
Trial phase: Not Applicable
ATC code: C01CA06 | R01AA04 | R01AB01 | R01BA03 | R01BA53 | S01FB01 | S01FB51 | S01GA05 | S01GA55
SMILES: CNC[C@H](O)c1cccc(O)c1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 106
Group description: Participants who were of Caucasian descent.
Eligibility criteria:
Inclusion Criteria:

Age between 18 and 40 years, inclusive.
Subject must be willing to give written informed consent and be able to adhere to diet and study schedules.
Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with the study evaluations.
Subjects must have a normal or clinically acceptable physical examination and ECG.
Clinical laboratory tests (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator.

Exclusion Criteria:

Any subject who has taken any prescription or over-the-counter drugs, other than oral contraception if female, within two weeks prior to study drug administration.
Subjects who are presently, or were formerly, narcotic addicts or alcoholics.
Subjects who have a clinically significant allergy/intolerance to phenylephrine.
Females with a positive serum/urine pregnancy test at screening.
Females who are nursing.
Subject using sildenafil or other phosphodiesterase inhibitors.
Intervention: Ciprofloxacin
Trial phase: Phase 3
ATC code: J01MA02 | J01RA10 | J01RA11 | J01RA12 | S01AE03 | S02AA15 | S03AA07
SMILES: O=C(O)c1cn(C2CC2)c2cc(N3CCNCC3)c(F)cc2c1=O
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: Ciprofloxacin 500 mg twice daily for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Men 18 yrs. or older
An elevated PSA (>2.5 ng/ml) and normal digital rectal exam
Have elected to proceed with a diagnostic 12-core prostate biopsy

Exclusion Criteria:

Previous prostate biopsy
History of prostate cancer
Urinary tract infections or prostatitis within one year of study entry
antibiotic use within one month prior to PSA level
pyuria or bacteruria on urinalysis
allergy to fluoroquinolones
Intervention: Ambrisentan
Trial phase: Phase 4
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: 3
Group description: Ambrisentan: Subjects will be initiated at 2.5 mg per day and increased to 5mg daily in 2 weeks and then 10mg daily if clinically tolerated (edema is controlled and symptoms are stable).
Eligibility criteria:
Inclusion Criteria:

Catheterization

Elevated pulmonary arterial pressure (PA mean >25mmHg)
Elevated pulmonary vascular resistance (>240 dynes.cm.sec-5) or transpulmonary gradient (>12 mmHg)
Elevated LVEDP (>15mmHg, but ≤23 mmHg)
Evidence of left ventricular diastolic dysfunction: LA>4.0, LVH or diastolic dysfunction by mitral filling pattern
Echocardiogram: Normal or mildly reduced LV ejection fraction (greater than or equal to 40%)
Symptomatic chronic HF (WHO functional class II-IV)
Baseline walk distance 100 to 400 meters
Age 18 - 80 (increased from 70)

Maximal treatment of diastolic dysfunction as noted by the treating physicians with no change in medical therapy for one month prior to entry

Exclusion Criteria:

Use of endothelin receptor antagonist, prostacyclin or PDE-5 inhibitor within 4 weeks of enrollment
Exercise capacity limited by other illness (other lung disease, arthritis, mobility limitations)
Uncontrolled systemic hypertension
Uncontrolled atrial fibrillation
Severe valvular disease
Pregnant females- females of child bearing potential will need to use contraceptive agent barrier given the teratogenicity associated with ERA's
Uncontrolled OSA
Intervention: Lidocaine
Trial phase: Not Applicable
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 116
Group description: Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
Eligibility criteria:
Inclusion Criteria:

18 to 75 years old at time of surgery - adult patients differ from pediatric patients in that adult spines are stiffer than pediatric patient.
Elective spine surgery
Two levels laminectomies or above with or without fusion or instrumentatioN
General anesthesia
Surgery performed at Cleveland Clinic with informed consent signed prior to sedation or anesthesia - consistent surgical team

Exclusion Criteria:

contraindication to lidocaine such as substantial hepatic impairment (ALT or AST more than twice normal)
renal impairment (serum creatinine >2 mg/dl),
seizure disorder requiring medication within 2 years
planned epidural anesthesia or analgesia
Intervention: Erlotinib
Trial phase: Phase 2
ATC code: L01EB02 | L01XE03
SMILES: C#Cc1cccc(Nc2ncnc3cc(OCCOC)c(OCCOC)cc23)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 19
Group description: 150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles

erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles.
Eligibility criteria:
Inclusion Criteria:

.Histologic or cytologic confirmation of pancreatic ductal adenocarcinoma.

Pancreatic cancer must be surgically resectable: a) no evidence of distant metastasis; b) clear fat plane around the celiac and superior mesenteric arteries; c) patent portal and superior mesenteric veins
No evidence of post-resection distant metastasis
Pathologic confirmation of R0/R1 status following surgical resection
Age ≥ 19 years
Male or female gender (not pregnant or lactating). If the subject is fertile, use of medically acceptable contraception will be required.
Patient should be able to understand and offer signed written informed consent prior to study entry.
No prior receipt of chemotherapy or radiotherapy
Patients must demonstrate a Eastern Cooperative Oncology Group(ECOG) P.S. of 0 or 1
End Organ function must be adequate meeting the below criteria at baseline:

White Blood Cell Count (WBC)> 3000/mm3, absolute neutrophil count(ANC)> 1500/mm3, Platelets>100,000mm3 Calculated creatinine clearance >50 ml/min, normal serum creatinine (mg/dL) (if calculated Crcl <50 ml/min, Crcl should measured and be > 50 ml/min) Bilirubin <3.0 mg/dL (patients with obstructive jaundice require preoperative endoscopic biliary stenting if total bilirubin >3.0 mg/dl) prothrombin time(PT) /partial thromboplastin time(PTT) below the upper limit of normal

Exclusion Criteria:

Diagnosis of active (treated in past 5 years) concomitant malignancy with exception of non-melanotic skin cancer
Transplant patients or patients receiving immunosuppression
Presence of an underlying disease state associated with active bleeding or a past medical history of coagulopathy
New York Heart Association Class IV congestive heart failure
Limited mental capacity or language skills to the extent simple instructions cannot be followed or information regarding adverse events cannot be provided
History of non-compliance with prescribed medical care

Post-Operative Phase Inclusion

No Evidence of Post-Resection Distant Metastasis
Pathological confirmation of R0/R1 status following Surgical resection
Patient must demonstrate a post-operative performance status of 0 or 1.

End Organ function must be adequate, meeting the below criteria at baseline:

WBC > 3000/mm³,ANC > 1500/mm³, Platelets > 100,000 mm³
Calculated Creatinine Clearance > 50 ml/min,Serum Creatinine < 1.5 mg/dl
Bilirubin < 3.0 mg/dl; aspartate aminotransferase(AST) and alanine aminotransferase (ALT) < 3 x normal value

PT/PTT/international normalized ratio(INR) within normal Limits.

-
Intervention: Nesiritide
Trial phase: Phase 4
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: 45
Group description: 2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age.
Subject must be able to understand the potential risks and benefits associated with the study.
Baseline systolic blood pressure ≥ 90 mm Hg at the time of enrollment.
Clinical symptoms of dyspnea and laboratory admission BNP levels > 500 pg/mL.
Neither pregnant or breastfeeding at the time of enrollment.
Authorization of patient's enrollment by patient's medical provider.

Exclusion Criteria:

<18 years of age
Denies written informed consent
Pregnant or lactating.
Baseline systolic BP < 90 mmHg or cardiogenic shock
No symptoms of congestion or admission BNP < 500 pg/mL
Known allergy to E.coli-derived products, or any history of anaphylactic reactions to nesiritide.
Receiving dialysis at the time of enrollment.
Serum creatinine > 2.5 mg/dL at the time of enrollment.
Intervention: Nitroglycerin
Trial phase: Phase 4
ATC code: C01DA02 | C01DA52 | C05AE01
SMILES: O=[N+]([O-])OCC(CO[N+](=O)[O-])O[N+](=O)[O-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 44
Group description: 10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
Eligibility criteria:
Inclusion Criteria:

At least 18 years of age.
Subject must be able to understand the potential risks and benefits associated with the study.
Baseline systolic blood pressure ≥ 90 mm Hg at the time of enrollment.
Clinical symptoms of dyspnea and laboratory admission BNP levels > 500 pg/mL.
Neither pregnant or breastfeeding at the time of enrollment.
Authorization of patient's enrollment by patient's medical provider.

Exclusion Criteria:

<18 years of age
Denies written informed consent
Pregnant or lactating.
Baseline systolic BP < 90 mmHg or cardiogenic shock
No symptoms of congestion or admission BNP < 500 pg/mL
Known allergy to E.coli-derived products, or any history of anaphylactic reactions to nesiritide.
Receiving dialysis at the time of enrollment.
Serum creatinine > 2.5 mg/dL at the time of enrollment.
Intervention: Raltegravir
Trial phase: Phase 4
ATC code: J05AJ01 | J05AR16 | J05AX08
SMILES: Cc1nnc(C(=O)NC(C)(C)c2nc(C(=O)NCc3ccc(F)cc3)c(O)c(=O)n2C)o1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication

raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication
Eligibility criteria:
Inclusion Criteria:

Stable antiretroviral therapy for at least 12 months
All plasma HIV RNA levels within the past year must be below level of detection (< 50 copies RNA/mL), although isolated single values > 50 but < 200 copies will be allowed.
Screening plasma HIV RNA levels < 50 copies RNA/mL
>90% adherence to therapy within the preceding 30 days, as determined by self-report
Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
CD4<350 cells/mm3 for at least one year ("immunologic non-responder") or CD4>=350 cells/mm3 for at least one year ("immunologic responder").

Exclusion Criteria:

Ongoing or prior use of any integrase inhibitor or R5 inhibitor.
Patients who plan to modify existing antiretroviral therapy in the next 24 weeks for any reason
Serious illness requiring hospitalization or parental antibiotics within preceding 3 months
Concurrent or recent exposure to any immunomodulatory drugs
Advanced liver disease or active hepatitis B or C
Patients with systolic blood pressure <100/70
Starting or stopping statin therapy during the trial
Intervention: Pioglitazone
Trial phase: Not Applicable
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 6
Group description: Treatment with pioglitazone for 3 months before spectroscopy, hyperinsulinemic-euglycemic clamp, control diet, blood sampling.
Eligibility criteria:
Inclusion Criteria:

Age 18 to 80, weight stable for at least 3 months

At lifetime maximal body weight and impaired glucose tolerance (ICT) by the World Health ORganization criteria:

fasting plasma glucose level of 100- 125mg/dL or
plasma glucose level between 140 to 149mg/dL following a 75gram oral glucose load

Exclusion Criteria:

Actively losing weight
Smokers
Alcohol consumption > 2 drinks/day
Prescription drug use
Recreational drug use
Type 2 Diabetes
Conditions that contraindicate treatment with pioglitazone such as CHF, impaired liver or kidney function or known sensitivity to pioglitazone
Intervention: Tacrolimus
Trial phase: Phase 4
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: 20
Group description: Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L

tacrolimus: tacrolimus 2mgs bd adjusted to obtain levels of 5-12ng/ml
Eligibility criteria:
Inclusion Criteria:

Idiopathic membranous glomerulonephritis on renal biopsy
Proteinuria - protein/creatinine ratio (PCR) > 100 units with hypoalbuminaemia or PCR > 300 units with normal serum albumin despite 3 months treatment with maximum tolerated doses of ace inhibitors and angiotensin 2 antagonists (or shorter if life threatening complications of nephrotic syndrome require institution of immediate immunosuppression)
Male or female patients aged 18 to 80 years

Exclusion Criteria:

Hepatitis B hepatitis C or HIV positive
Malignancy (all patients must have a CT chest abdomen and pelvis and other investigations if clinically indicated)
Untreated infection
Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception
Any condition judged by the investigator that would cause the study to be detrimental to the patient
Intervention: MYCOPHENOLATE MOFETIL
Trial phase: Phase 4
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: 20
Group description: tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L

tacrolimus and mycophenolate mofetil: tacrolimus 2mg bd adjusted to achieve levels of 5-12ng/L mycophenolate mofetil 500mgs bd adjusted to achieve levels of 1.5-3mg/L
Eligibility criteria:
Inclusion Criteria:

Idiopathic membranous glomerulonephritis on renal biopsy
Proteinuria - protein/creatinine ratio (PCR) > 100 units with hypoalbuminaemia or PCR > 300 units with normal serum albumin despite 3 months treatment with maximum tolerated doses of ace inhibitors and angiotensin 2 antagonists (or shorter if life threatening complications of nephrotic syndrome require institution of immediate immunosuppression)
Male or female patients aged 18 to 80 years

Exclusion Criteria:

Hepatitis B hepatitis C or HIV positive
Malignancy (all patients must have a CT chest abdomen and pelvis and other investigations if clinically indicated)
Untreated infection
Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception
Any condition judged by the investigator that would cause the study to be detrimental to the patient
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
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: 80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
Eligibility criteria:
Inclusion Criteria:

Healthy male and/or female subjects
Body Mass Index (BMI) of approximately 18 to 30 kg/m2

Exclusion Criteria:

Any condition possibly affecting drug absorption
A positive urine drug screening
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
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: 80-mg Commercial atorvastatin tablet (Lipitor®)
Eligibility criteria:
Inclusion Criteria:

Healthy male and/or female subjects
Body Mass Index (BMI) of approximately 18 to 30 kg/m2

Exclusion Criteria:

Any condition possibly affecting drug absorption
A positive urine drug screening
Intervention: Maraviroc
Trial phase: Phase 3
ATC code: J05AX09
SMILES: Cc1nnc(C(C)C)n1[C@@H]1C[C@H]2CC[C@@H](C1)N2CC[C@H](NC(=O)C1CCC(F)(F)CC1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 26
Group description: maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.
Eligibility criteria:
Inclusion Criteria:

Stable antiretroviral therapy for at least 12 months
All plasma HIV RNA levels within the past year must be below level of detection (< 50 copies RNA/mL), although isolated single values > 50 but < 200 copies will be allowed.
Screening plasma HIV RNA levels < 50 copies RNA/mL
>90% adherence to therapy within the preceding 30 days, as determined by self-report
Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.

Exclusion Criteria:

Ongoing or prior use of any integrase inhibitor or R5 inhibitor.
Patients who plan to modify existing antiretroviral therapy in the next 24 weeks for any reason
Serious illness requiring hospitalization or parental antibiotics within preceding 3 months
Concurrent or recent exposure to any immunomodulatory drugs
Advanced liver disease or active hepatitis B or C
Patients with systolic blood pressure <100/70
Starting or stopping statin therapy during the trial
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: No
Participants at risk: 25
Group description: 4-wk treatment period with open label lubiprostone 24 mcg tablet po twice daily
Eligibility criteria:
Inclusion Criteria: Functional constipation by Rome III criteria

Exclusion Criteria:

History of esophageal or gastric surgery (including vagotomy, antireflux, and obesity surgery)
History of small bowel or colon resection (excluding appendectomy and cholecystectomy)
History of gastric outlet, small bowel, or colon obstruction
History of surgery for small bowel adhesion lysis
History of surgery for gastroparesis
Diagnosis of diabetes requiring daily medications
Diagnosis of connective tissue d/o (including scleroderma, lupus, mixed connective tissue disorder)
Diagnosis of neuromuscular disorder (including multiple sclerosis, Parkinson, muscular dystrophy, dysautonomia, dystonia)
Disorders of small bowel pseudo-obstruction or dumping syndrome
Untreated or poorly controlled hypothyroidism
Taking an opiate medication daily
Taking a medication daily that can cause constipation (calcium channel blocker, anticholinergic, iron supplements, etc.)
Active cancer being treated
History of significant liver, kidney, cardiac disease that may interfere with study compliance
Known allergy or side effects to lubiprostone
Non-ambulatory patients: bed-ridden, nursing home resident, etc.