anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: EXENATIDE
Trial phase: Phase 2
ATC code: A10BJ01
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24

exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24
Eligibility criteria:
Inclusion Criteria:

Age >18 years, < 70 years, inclusive
Type 2 diabetes on stable doses of sulfonylurea and/or metformin
Body mass index > 35 kg/m2
Presumed diagnosis of NAFLD based upon
an ALT > 1.5 times the upper limit of reference range,
no evidence of other causes of liver disease and
ultrasound findings compatible with fatty liver

Exclusion Criteria:

Clinical signs of cirrhosis as evidenced by any of the following
spider angiomata,
splenomegaly,
ascites
jaundice
encephalopathy
INR > 1.2
Platelet count < 100,000/ml
Serum albumin < 3.0 g/dL
Other liver disease including chronic viral hepatitis (B or C), alcohol abuse, hemochromatosis, alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis or primary biliary cirrhosis.
Current use of > 20 g of alcohol per day or unwillingness to avoid alcohol during the course of the study
Treatment with a thiazolidinedione or exenatide within 6 months of enrolling in the study
AST or ALT > 10 times the upper limit of normal
Treatment with any investigational drug within 4 weeks of enrollment
Pre-menopausal, fertile women unwilling to use contraceptives during the study period.
Pregnancy or lactation
Initiation or change in dose of hypolipidemic drugs (statins, niacin, cholestyramine are allowed) within 6 months of enrollment
Use of anticoagulation, bleeding disorders or other contraindications to liver biopsy
Intervention: Aliskiren
Trial phase: Phase 3
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 331
Group description: Aliskiren 300 mg once daily
Eligibility criteria:
Inclusion Criteria:

Patients must have msDBP ≥ 90 mmHg and < 110 mmHg at the visit immediately prior to Visit 3
Patients must have msDBP >OR= 95 mmHg and < 110 mmHg at Visit 3
Patients must have an absolute difference of < or =10 mmHg in their mean sitting diastolic blood pressure (msDBP) from Visit 2 to Visit 3

Exclusion Criteria:

Severe hypertension (grade 3 WHO classification; msDBP >or= 110 mmHg and/or msSBP >or = 180 mmHg).
History or evidence of a secondary form of hypertension.
History of transient ischemic cerebral attack within 12 months of visit 1.
Current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates)
Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8% at Visit 1.
Known or suspected contraindications to the study medications, including history of allergy to ramipril or other ACE Inhibitors.

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Aliskiren
Trial phase: Phase 3
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 323
Group description: Aliskiren 150 mg once daily
Eligibility criteria:
Inclusion Criteria:

Patients must have msDBP ≥ 90 mmHg and < 110 mmHg at the visit immediately prior to Visit 3
Patients must have msDBP >OR= 95 mmHg and < 110 mmHg at Visit 3
Patients must have an absolute difference of < or =10 mmHg in their mean sitting diastolic blood pressure (msDBP) from Visit 2 to Visit 3

Exclusion Criteria:

Severe hypertension (grade 3 WHO classification; msDBP >or= 110 mmHg and/or msSBP >or = 180 mmHg).
History or evidence of a secondary form of hypertension.
History of transient ischemic cerebral attack within 12 months of visit 1.
Current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates)
Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8% at Visit 1.
Known or suspected contraindications to the study medications, including history of allergy to ramipril or other ACE Inhibitors.

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Aliskiren
Trial phase: Phase 3
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 332
Group description: Aliskiren 75 mg once daily
Eligibility criteria:
Inclusion Criteria:

Patients must have msDBP ≥ 90 mmHg and < 110 mmHg at the visit immediately prior to Visit 3
Patients must have msDBP >OR= 95 mmHg and < 110 mmHg at Visit 3
Patients must have an absolute difference of < or =10 mmHg in their mean sitting diastolic blood pressure (msDBP) from Visit 2 to Visit 3

Exclusion Criteria:

Severe hypertension (grade 3 WHO classification; msDBP >or= 110 mmHg and/or msSBP >or = 180 mmHg).
History or evidence of a secondary form of hypertension.
History of transient ischemic cerebral attack within 12 months of visit 1.
Current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates)
Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8% at Visit 1.
Known or suspected contraindications to the study medications, including history of allergy to ramipril or other ACE Inhibitors.

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Ramipril
Trial phase: Phase 3
ATC code: C09AA05 | C09BA05 | C09BB05 | C09BB07 | C09BX03 | C09BX05 | C10BX04 | C10BX06 | C10BX17 | C10BX18
SMILES: [H][C@@]12CCC[C@]1([H])N(C(=O)[C@H](C)N[C@@H](CCc1ccccc1)C(=O)OCC)[C@H](C(=O)O)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 329
Group description: Ramipril 5 mg once daily
Eligibility criteria:
Inclusion Criteria:

Patients must have msDBP ≥ 90 mmHg and < 110 mmHg at the visit immediately prior to Visit 3
Patients must have msDBP >OR= 95 mmHg and < 110 mmHg at Visit 3
Patients must have an absolute difference of < or =10 mmHg in their mean sitting diastolic blood pressure (msDBP) from Visit 2 to Visit 3

Exclusion Criteria:

Severe hypertension (grade 3 WHO classification; msDBP >or= 110 mmHg and/or msSBP >or = 180 mmHg).
History or evidence of a secondary form of hypertension.
History of transient ischemic cerebral attack within 12 months of visit 1.
Current angina pectoris requiring pharmacological therapy (other than those patients on a stable dose of oral or topical nitrates)
Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8% at Visit 1.
Known or suspected contraindications to the study medications, including history of allergy to ramipril or other ACE Inhibitors.

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Atorvastatin
Trial phase: Phase 2
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: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Atorvastatin, 40 mg qd
Eligibility criteria:
Inclusion Criteria: Women with PCOS

8 or fewer menstrual periods per year
elevated serum total testosterone
elevated LDL cholesterol

Exclusion Criteria:

current pregnancy or breastfeeding
current use of oral contraceptives, progestins
insulin sensitizing medications
thyroid disease, hyperprolactinemia, active liver disease, type 1 or type 2 diabetes
Intervention: Thalidomide
Trial phase: Phase 3
ATC code: L04AX02
SMILES: O=C1CCC(N2C(=O)c3ccccc3C2=O)C(=O)N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Patients will receive Thalidomide for a period of 24 weeks. Blood will be drawn every 4 weeks for a total of 28 weeks to establish the effect on albumin, prealbumin and CRP.

Thalidomide : 100 mg by mouth at night for 4 weeks; 200 mg by mouth at night for 20 weeks
Eligibility criteria:
Inclusion Criteria:

End stage renal disease (ESRD) patients on hemodialysis for at least 3 months.
Serum C reactive protein level of ≥ 0.8 mg/dl.
Serum albumin < 3.8 g/dl (BCG).
Signing a written informed consent form.
Willingness and ability to comply with the FDA-mandated S.T.E.P.S ® program.
Age > 18 years.

Exclusion Criteria:

Pregnant and/ or lactating female.
Active infection within the previous 8 weeks requiring administration of antibiotics.
Patients receiving systemic immunosuppressive therapy.
Patients with HIV.
Intervention: Albuterol Sulfate
Trial phase: Phase 4
SMILES: CC(C)(C)NCC(O)c1ccc(O)c(CO)c1.CC(C)(C)NCC(O)c1ccc(O)c(CO)c1.O=S(=O)(O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: Participants received single actuation of albuterol 90 mcg, administered using MDI in treatment period 2.
Eligibility criteria:
Inclusion Criteria:

Asthma of a minimum of 6 months duration
Participants who demonstrate poor inhalation/actuation coordination when evaluated at screening utilizing the Aerosol Inhalation Monitor (AIM, Vitalograph) prior to any training and following training in 3 consecutive attempts
Reversible bronchoconstriction of >12% increase in FEV1 with a cumulative dose of 450 mcg of albuterol
The reversibility (FEV1) of ≤70% following administration of the initial 90 mcg of albuterol
Ability to perform spirometry reproducibly
Ability to self-perform peak expiratory flow (PEF) determinations and report scores on diaries
Can tolerate withdrawal of applicable medications for qualification at screening
Otherwise healthy individuals
Non-smokers for at least 2 years prior to the screening visit

Exclusion Criteria:

Allergy or sensitivity to albuterol
Exposure to investigational drugs within 30 days prior to the screening visit
Continuous treatment with beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, and/or systemic corticosteroids
Treated with oral or injectable corticosteroids within the 6 weeks prior to the screening visit
The prescribed dose regimen of any required antileukotrienes, inhaled corticosteroids and/or inhaled cromolyn and/or nedocromil had not been stable for at least 4 weeks prior to the screening visit
Inability to tolerate or unwillingness to comply with required washout periods for all applicable medications
Hospitalization for acute exacerbation of asthma more than twice in past year
Treatment in an emergency room or hospitalization for asthmatic symptoms within 3 months prior to the screening visit
An upper respiratory tract infection and/or sinusitis associated with exacerbation of asthma that is unresolved 3 weeks prior to the screening visit
History and/or presence of any clinically significant non-asthmatic acute or chronic disease
Known or suspected substance abuse
Previous enrollment in an IVAX Research-sponsored Albuterol-HFA asthma study Note: Other inclusion and exclusion criteria may apply.
Intervention: Betamethasone
Trial phase: Phase 3
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: 0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
Eligibility criteria:
Inclusion Criteria:

Diagnosis of sickle cell anemia (Hgb SS) or sickle-β0-thalassemia (Hgb Sβ0)

Current episode of ACS, defined as a new lobar or segmental pulmonary infiltrate seen on a chest radiograph and two or more of the following findings:

Temperature of 38.5°C or higher
Tachypnea (i.e., rapid breathing)
Dyspnea or increased work of breathing
Chest wall pain
Oxygen saturation of less than 90% in room air by pulse oximetry
Current episode of ACS diagnosed in the 24 hours prior to study entry
Ability to take medication in capsule form

Exclusion Criteria:

Prior participation in this study

Diagnosed with any medical condition that will likely be worsened by corticosteroid therapy, including any of the following conditions:

Diabetes mellitus
High blood pressure
Esophageal or gastrointestinal ulceration or bleeding
Known avascular necrosis
Diagnosis of ACS in the 6 months prior to study entry
Treatment with oral or parenteral corticosteroid therapy for any reason in the 14 days prior to study entry
Use of inhaled corticosteroids or systemic corticosteroids for respiratory illness in the 3 months prior to study entry
Long-term lung condition that requires treatment with corticosteroids
Participation in a program of chronic transfusions that ended fewer than 4 months ago. A program of chronic transfusions includes a regimen of serial simple or exchange transfusions given at least every 6 weeks for at least three consecutive transfusions for the prevention of SCD-related complications.
Pregnant
Treatment with any investigational drug in the 90 days prior to study entry
History of either tuberculosis or a positive skin test for tuberculosis
Known HIV infection or a current systemic fungal infection
Intervention: VALACYCLOVIR
Trial phase: Phase 2
ATC code: J05AB11
SMILES: CC(C)[C@H](N)C(=O)OCCOCn1cnc2c(=O)nc(N)[nH]c21
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: 500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
Eligibility criteria:
Inclusion Criteria:

HIV-1 seropositive
HSV-2 seropositive
Plans to deliver in Nairobi
Resides and plans to remain in Nairobi for 12 months postpartum
18 years of age or older
CD4 count>250 cells/μl

Exclusion Criteria:

indication for highly active antiretroviral therapy (e.g., WHO stage III or IV)
hypersensitivity to valacyclovir or acyclovir
Intervention: Oraqix
Trial phase: Phase 2
SMILES: CCCNC(C)C(=O)Nc1ccccc1C.CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 50
Group description: Participants will have a dose of EMLA Cream applied to the venipuncture site 1 hour before the procedure. Dosage based on age and weight: 4-6 years old and heavier than 10kg will receive 10g of EMLA; 7-12 years old and more than 20kg will receive 20g of EMLA.

EMLA Cream: 60 minutes x1
Eligibility criteria:
Inclusion Criteria:

Children in outpatient clinics requiring venipuncture for medical care
Ages 4-12 years old
The ability to demonstrate proper understanding of the Wong-Baker FACES Pain Ranking Scale
Parents of enrolled children need to be present during the procedure and be willing to rate their child's pain

Exclusion Criteria:

Damaged or inflamed skin at the designated application site
Known sensitivity to components of Synera or EMLA (lidocaine, tetracaine, or local anesthetics of the amide or ester type, Para Aminobenzoic (PABA) derivatives)
Contraindications to SYnera or EMLA use (Severe hepatic disease, history of drug-induced methemoglobinemia, taking Class 1 antiarrhythmics)
Use of analgesics during the past 24 hours
Intervention: Lacosamide
Trial phase: Phase 3
ATC code: N03AX18
SMILES: COC[C@@H](NC(C)=O)C(=O)NCc1ccccc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 322
Group description: Lacosamide tablets for dosing 100 -800 mg/day
Eligibility criteria:
Inclusion Criteria:

Subject has entered the Maintenance Phase of the double-blind trial, SP902, (ie, has taken at least 1 dose of SP902 Maintenance Phase trial medication) and either completed SP902 or met an exit criterion in SP902; subject is allowed up to 2 concomitant Antiepileptic Drugs (AEDs)

Exclusion Criteria:

Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial, or is experiencing an ongoing Serious Adverse Event (SAE)
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
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 10
Group description: Pioglitazone

Pioglitazone: 30 mg once a day
Eligibility criteria:
Inclusion Criteria:

≥ 18 < 50 years of age
Healthy volunteers must be in general good health as determined by a medical history.
Ability to understand and sign the informed consent form
Ability to adhere to the protocol.
Willing to use an acceptable form of birth control

Exclusion Criteria:

History of diabetes requiring insulin
The use of NSAIDS (ibuprofen) or corticosteroids including inhaled steroids. Nasal steroids are acceptable.
The use of statin lowering medications
Active gingival disease (Active tooth or gum disease)
Any chronic inflammatory condition that immuno compromises the volunteer as determined by medical history.
Pregnant or planning to become pregnant
Intervention: Duloxetine
Trial phase: Phase 4
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Duloxetine : 60 mg capsules
Eligibility criteria:
Inclusion Criteria for Depressed Patients:

Ages 18 - 60 years and able to give voluntary informed consent.
Satisfy criteria for Major Depressive Disorder (MDD) and current depressed episode using the Structured Clinical Interview for DSM-IV (SCID-IV).
17-item Hamilton Depression Rating Scale (HDRS) score > 18.
Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire.

Able to be managed as outpatients for initial assessment and during treatment as ascertained by the following:

Symptoms not worsening by more than 10 points on the HDRS during the course of the study.
No danger to self or others.

Exclusion criteria for patients:

Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, bipolar disorder, atypical psychosis, mental retardation, or organic mental (including organic mood) disorder.
Known hypersensitivity to duloxetine or any of the inactive ingredients.
On monoamine oxidase inhibitors in the past 2 weeks.
History of narrow angle glaucoma
Lack of response of the current episode of depression to two or more adequate courses of antidepressant therapy at a clinically appropriate dose for a minimum of 4 weeks or, in the judgment of the investigator, the patient meets criteria for treatment-resistant depression.
Use of neuroleptic in the past 2 weeks.
Use of antidepressants in the past 2 weeks. If on fluoxetine in the past, then should not have been on this medication for 4 weeks.
History of lack of response to duloxetine.
Use of mood stabilizers in the past 2 weeks.
Use of benzodiazepines in the past 2 weeks.
Acutely suicidal or homicidal or requiring inpatient treatment.
Meeting DSM-IV criteria for other substance dependence within the past year, except caffeine or nicotine. The criteria will be evaluated by interview and urinary toxicology screening initially and on test days.
Use of alcohol in the past 1 week.
No serious medical or neurological illness as assessed by physical examination and laboratory examination including CBC and blood chemistry.
Current pregnancy or breast-feeding.
Metallic implants.
Previously known positive HIV blood test as reported by the subject.
Intervention: Lidocaine
Trial phase: Phase 4
ATC code: C01BB01 | C05AD01 | D04AB01 | N01BB02 | N01BB52 | R02AD02 | S01HA07 | S02DA01
SMILES: CCN(CC)CC(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 24
Group description: patients in this arm were administered active drug
Eligibility criteria:
Inclusion Criteria:

Full term (>=37 weeks gestation)
Age 0-60 Days
Undergoing Lumbar Puncture

Exclusion Criteria:

Unstable
Premature (<37 weeks gestation)
Allergy to study medicine
Parent refusal of consent
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: On-Q pump containing Bupivacaine implanted

On-Q Pain Pump: Bupivicaine .375% via on-Q pump will be infused at a rate of 2cc/hr intraperitoneally
Eligibility criteria:
Inclusion Criteria:

Patients undergoing laparoscopic cholecystectomy or Lap-Band ASA III or less

Exclusion Criteria:

Patients who refuse consent
Are converted from laparoscopy to open surgery
Are allergic to bupivacaine
Are unable to followup
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Saline used in the implanted On-Q device
Eligibility criteria:
Inclusion Criteria:

Patients undergoing laparoscopic cholecystectomy or Lap-Band ASA III or less

Exclusion Criteria:

Patients who refuse consent
Are converted from laparoscopy to open surgery
Are allergic to bupivacaine
Are unable to followup
Intervention: Rifaximin
Trial phase: Not Applicable
ATC code: A07AA11 | D06AX11
SMILES: COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 42
Group description: Rifaximin: 550mg BID rifaximin for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Age 18-65 years
Cirrhosis diagnosed on clinical grounds
MHE diagnosed by abnormalities in a psychometric battery (NCT-A, NCT-B, ICT BDT and DST impaired beyond 2 standard deviations of known control values on any of the above 3 tests will be considered to have MHE)
Current drivers (valid driving license and driving at least 20 miles/week)
All women of child-bearing potential will be required to use effective contraception

Exclusion Criteria:

Current or recent (< 6 month) use of alcohol (AUDIT questionnaire will be used; any cirrhotic with a value of > 0 will be excluded) and a positive blood alcohol level
Use of antibiotics within last 6 weeks
Allergy to rifaximin, rifabutin, rifampin, or rifapentine
Infection or gastrointestinal hemorrhage within the last 6 weeks
Renal insufficiency
Hepatocellular carcinoma
Psychoactive drug use, including interferon concurrently
Non-drivers and those who drive less than 20 miles/week
Pregnancy and breastfeeding

Excluding patients with OHE:

Detailed neurological examination to check for dysarthria, asterixis, ataxia and disorientation
Detailed history-taking from friends/relatives only after taking the patient's permission
Mini-mental status examination > 25
Episode of overt (clinical hepatic encephalopathy) within 6 months
Current treatment with lactulose, rifaximin, zinc, or metronidazole