anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Yttrium
Trial phase: Phase 3
SMILES: [Y]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 751
Group description: 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles
Eligibility criteria:
Inclusion Criteria:

Subject has completed the double-blind study SL0009 (NCT01262365) or SL0010 (NCT01261793) or terminated prematurely at Week 16 or later in SL0009 or SL0010 due to lack of efficacy and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
Subject has completed open-label study SL0006 (NCT00383513) or SL0008 (NCT00660881), and would, in the opinion of the investigator, continue to benefit from continued epratuzumab treatment
Women of childbearing potential must agree to use an acceptable method of birth control

Exclusion Criteria:

Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A disease
Subjects with active, severe SLE disease activity which involves the renal system
Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections
Substance abuse or dependence
History of malignant cancer
Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion
Intervention: Sildenafil Citrate
Trial phase: Phase 2
SMILES: CCCc1nn(C)c2c(=O)[nH]c(-c3cc(S(=O)(=O)N4CCN(C)CC4)ccc3OCC)nc12.O=C(O)CC(O)(CC(=O)O)C(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 1
Group description: Intravenous Sildenafil: 0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.
Eligibility criteria:
Inclusion Criteria:

Signed informed consent from legally acceptable guardian

PPHN or hypoxemic respiratory failure associated with:

Idiopathic PPHN
Meconium aspiration syndrome
Respiratory distress syndrome
Sepsis
Pneumonia
Greater than or equal to 35 weeks gestation
Age at enrollment less than 72 hours
Moderate hypoxemic respiratory failure, with 12<OI<35 (oxygenation index, calculated as FiO2 * mean airway pressure * 100 / postductal PaO2)
Absence of structural heart disease (except patent ductus arteriosus, atrial septal defect <1cm, or muscular ventricular septal defect < 2mm)
Absence of lethal congenital anomaly
Not participating in another concurrent experimental study

Exclusion Criteria:

Prior or immediate need for iNO or ECMO
Profound hypoxemia: qualifying PaO2 <30 mmHg, from a blood gas drawn within 30 minutes of starting study drug infusion.
Hypotension: Mean arterial pressure <35 mmHg
Congenital heart disease, except patent ductus arteriosus, atrial septal defect <1cm, or muscular ventricular septal defect <2mm
Congenital diaphragmatic hernia or lung hypoplasia syndromes, diagnosed on the basis of prolonged oligohydramnios
Active seizures
Apgar score of <3 at 5 minutes
Bleeding diathesis
Receipt of any other experimental drug or device

Receipt of any prohibited concurrent medication:

Potent cytochrome P450 3A4 inhibitors (e.g., erythromycin, ketoconazole, itraconazole and protease inhibitors)
Endothelin antagonists (e.g. Tracleer/bosentan)
Intravenous nitrates or nitric oxide donors
Known hereditary degenerative retinal disorders such as retinitis pigmentosa.
In the opinion of the investigator, a subject who is not likely to complete the study or would be considered inappropriate for the study, for any reason.
Intervention: Pregnenolone
Trial phase: Phase 4
SMILES: [H][C@@]12CC=C3C[C@@H](O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(C)=O)CC[C@@]21[H]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 38
Group description: This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.

Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.
Eligibility criteria:
Inclusion Criteria:

Men and Women of all races age 18-75 years
Diagnosis of bipolar I, II or not otherwise specified (NOS) disorders currently meeting criteria for a major depressive episode
English speaking

Exclusion Criteria:

Active suicidal ideation with plan and intent
Treatment resistant depression
Vulnerable population (i.e. pregnant, cognitively impaired, incarcerated)
Severe or life threatening medical condition
History of allergic reaction or side effects with prior pregnenolone use
Current substance use disorder defined as meeting criteria for abuse or dependence based on the Structured Clinical Interview for the Diagnostic and Statistical Manual (DSM)(SCID) interview and self-reported use within the past 3 months or a positive baseline urine drug screen
Removal or addition of concomitant psychiatric medications within 10 days prior to randomization
Current Warfarin therapy
Current use of oral contraceptives
Current hormone replacement therapy
History of heart disease or arrhythmias
Current (past 7 days) systemic
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: 16
Group description: Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
Eligibility criteria:
Inclusion Criteria:

Age 18 and above
Admitted to a general medicine or medicine subspecialty service
Insulin use (>20 units/day) or hyperglycemia. Hyperglycemia is defined as glucose greater than 180 mg/dL on at least 2 occasions separated by at least 4 hours apart.

Exclusion Criteria:

Type 1 diabetes
Hospital stay expected less than 48 hours
Inability to consent
Pregnancy
Prisoners
Previous participation
Autonomic neuropathy
Conditions that preclude accurate heart rate variability monitoring: atrial fibrillation, frequent ectopy, congestive heart failure, paced heart rhythms
Conditions which require lower dose insulin algorithms: end stage renal or liver disease
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: 17
Group description: IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
Eligibility criteria:
Inclusion Criteria:

Age 18 and above
Admitted to a general medicine or medicine subspecialty service
Insulin use (>20 units/day) or hyperglycemia. Hyperglycemia is defined as glucose greater than 180 mg/dL on at least 2 occasions separated by at least 4 hours apart.

Exclusion Criteria:

Type 1 diabetes
Hospital stay expected less than 48 hours
Inability to consent
Pregnancy
Prisoners
Previous participation
Autonomic neuropathy
Conditions that preclude accurate heart rate variability monitoring: atrial fibrillation, frequent ectopy, congestive heart failure, paced heart rhythms
Conditions which require lower dose insulin algorithms: end stage renal or liver disease
Intervention: Zidovudine
Trial phase: Phase 2
ATC code: J05AF01 | J05AR01 | J05AR04 | J05AR05
SMILES: Cc1cn([C@H]2C[C@H](N=[N+]=[N-])[C@@H](CO)O2)c(=O)[nH]c1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: 250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks.
Eligibility criteria:
Inclusion Criteria:

age 55 to 85 years;
should have a mild-to-moderate AD diagnosis (MMSE 10-26 inclusive);
should have evidence of elevated cortical amyloid by PET using florbetapir F18 (Amyvid) [i.e. a positive scan], assessed qualitatively according to the Amyvid product label.
if on anti-dementia treatment should be on stable treatment for at least 2 months (i.e. cholinesterase inhibitor and/or Memantine or Axona);
stable on all other medications for at least 30 days prior to screen;
should be fluent in English;
should be physically able to participate by medical history, clinical exam and tests;
should have a study partner to accompany them to scheduled visits.

Exclusion Criteria:

clinically relevant arrhythmias;
a resting pulse less than 50;
active cancer other than non-melanoma skin cancers;
use of another investigatory drug within 2 months of screening;
significant stroke or head trauma by history or MRI;
contraindication for having a MRI;
diagnostic and Statistical Manual of Mental Disorders-IV criteria for a current major psychiatric disorder;
sensitivity to yeast or yeast products;
impaired kidney function as measured by a Glomerular Filtration Rate less than 60 milliliters/min;
preexisting fluid retention, pulmonary infiltrates, or congestive heart failure;
history of moderate-to-severe lung disease;
history of moderate-to-severe liver disease;
pregnant women, or any women who feel they are likely to become pregnant during the study;
prisoners.
Intervention: Mosapride citrate
Trial phase: Phase 3
SMILES: CCOc1cc(N)c(Cl)cc1C(=O)NCC1CN(Cc2ccc(F)cc2)CCO1.O=C(O)CC(O)(CC(=O)O)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 170
Group description: oral use of mosapride citrate

mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
Eligibility criteria:
Inclusion Criteria:

Patients who has been diagnosed with functional constipation according to Rome Ⅲ criteria
Patients who are aged 18-75 years old
Stop medication or acupuncture (if any) 1 week before randomization and uninvolved in other trials
Sign the informed consent out of one's own will

Exclusion Criteria:

Secondary constipation
Patients with consciousness impairment, psychotic patients or patients unable to express clearly
Patients with malignant tumor in progressive stage, severe wasting disease and liable to be infected and bleed
Patients with severe cardiovascular disease, hepatic injury, renal damage, digestive disease or hematological diseases
Women in pregnancy and lactation period
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: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 200
Group description: Women randomized to the Lidocaine arm will receive a total of 3-5cc of 2% gel at the tenaculum site and within the endocervical canal

2% lidocaine gel: 3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion
Eligibility criteria:
Inclusion Criteria:

age 18-45 yrs
selecting intrauterine device contraception
able and willing to consent

Exclusion Criteria:

non-English speaking
current intrauterine device use
expulsion of intrauterine device within 2 weeks
allergy to lidocaine or water based lubricant
Intervention: ASCORBIC ACID
Trial phase: Not Applicable
ATC code: A11GA01 | A11GB01 | B03AA10 | G01AD03 | S01XA15
SMILES: O=C1OC(C(O)CO)C(O)=C1O
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 200
Group description: Women randomized to the placebo arm will receive a total of 3-5cc of water based lubricant at the tenaculum site and within the the endocervical canal

Water based lubricant: 3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to IUD insertion
Eligibility criteria:
Inclusion Criteria:

age 18-45 yrs
selecting intrauterine device contraception
able and willing to consent

Exclusion Criteria:

non-English speaking
current intrauterine device use
expulsion of intrauterine device within 2 weeks
allergy to lidocaine or water based lubricant
Intervention: Creatine monohydrate
Trial phase: Phase 2
SMILES: CN(CC(=O)O)C(=N)N.O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
Eligibility criteria:
Inclusion Criteria:

Individuals who have completed the CREST-UP1 study.
Individuals who are able to take oral medication.
Individuals capable of providing informed consent and complying with trial procedures.

Exclusion Criteria:

History of known sensitivity or intolerability to creatine.
Clinical evidence of unstable medical illness in the investigator's judgment.

Additional eligibility criteria apply.
Intervention: Varenicline
Trial phase: Phase 2
ATC code: N07BA03 | S01XA28
SMILES: c1cnc2cc3c(cc2n1)C1CNCC3C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 9
Group description: Smoking counseling, Varenicline: Experimental

Interventions:

Behavioral: smoking counseling
Drug: varenicline

Smoking counseling: Counseling sessions provided by trained smoking counselor during 1st day of study along with 28 day supply of varenicline

Varenicline: Varenicline (an approved medication for smoking cessation)
Eligibility criteria:
Inclusion Criteria:

The sample, 40 women and 40 men, will be hospitalized patients recruited from Stanford Hospital and Clinics who report smoking at least 10 cigarettes per day prior to hospitalization, have confirmed tobacco use by cotinine testing, and an expected hospitalization of at least 3 days duration from the date of study enrollment. Intention to quit smoking will not be required for study participation.

Exclusion Criteria:

- Study exclusion criteria are: dementia or other brain injury precluding ability to participate; Alzheimer's Disease; Parkinson's Disease; Huntington's Disease; meningitis; seizure disorder of a sustained nature; delirium; brain surgery; drug and/or alcohol dependence; suicidal ideation; end-stage renal disease (i.e., on dialysis); hypertensive crisis; stroke; myocardial infarction (MI) with severe cardiac damage; pregnancy or breastfeeding; non-English speaking; complete homelessness; or currently engaged in tobacco treatment. Study staff will consult with clinical staff prior to approach for study enrollment. In cases of severe renal impairment (estimated creatinine clearance <30 mL/min), medical staff will consult with participants' physician to assess the appropriateness for study enrollment.
Intervention: Amoxicillin
Trial phase: Not Applicable
ATC code: A02BD01 | A02BD03 | A02BD04 | A02BD05 | A02BD06 | A02BD07 | A02BD10 | A02BD11 | A02BD12 | A02BD13 | A02BD14 | A02BD15 | A02BD16 | J01CA04 | J01CR50
SMILES: [H][C@]12SC(C)(C)[C@H](C(=O)O)N1C(=O)[C@H]2NC(=O)[C@H](N)c1ccc(O)cc1
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days
Eligibility criteria:
Inclusion Criteria:

Age 18 to 39 years (male or female)
Good general health
Able to comply with study requirements and to provide informed consent
For women of childbearing potential
A negative urine pregnancy test immediately prior to starting the study treatment
Agreement to comply with approved methods of contraception during the period of active study treatment (not required during follow-up)

Exclusion Criteria:

Any diagnosed autoimmune disease
History of organ transplantation
Known chronic or recurrent systemic disorder associated with immunocompromise
A history of allergy or hypersensitivity to mushroom or mushroom extract, brewer's or baker's yeast or to penicillins or cephalosporins (including amoxicillin).
History of severe allergic reaction (requiring hospital admission and/or the administration of parenteral medication or associated with dyspnoea, wheezing, hypotension, loss of consciousness).
Systemic antibacterial therapy during the 3 months prior to study enrollment
New prescription medications during the 4 weeks prior to study enrollment
Prescription or OTC medications or supplements that are known to alter gut function or microflora (i.e. acid antisecretory drugs, probiotics) during the 4 weeks prior to study enrollment
Active gastrointestinal or metabolic disease
Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy)
History of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily
Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol.
Intervention: Roxadustat
Trial phase: Phase 2
ATC code: B03XA05
SMILES: Cc1nc(C(=O)NCC(=O)O)c(O)c2ccc(Oc3ccccc3)cc12
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: Participants on HD received roxadustat capsules at the applicable dose (up to a maximum roxadustat dose of 140, 200, and 300 mg) based on weight and Hb level, administered orally TIW for 12 weeks.
Eligibility criteria:
Inclusion Criteria:

Receiving HD or PD for native kidney end-stage renal disease (ESRD) for 2 weeks to 4 months, prior to randomization
Mean of the 2 most recent Hb values during the screening period, obtained at least 7 days apart, must be <10.0 grams (g)/deciliter (dL), with a difference of ≤1.0 g/dL between the 2 values
Body weight 40 to 140 kilograms (kg)

Exclusion Criteria:

Previously received erythropoiesis-stimulating agents
Received IV iron within 4 weeks of randomization
Received red blood cell transfusion within 8 weeks prior to randomization or anticipated need for transfusion during the treatment period
Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab)
History of chronic liver disease
Clinically significant infection
New York Heart Association Class III or IV congestive heart failure
History of malignancy, except the following: cancers determined to be cured or in remission for ≥5 years, curatively resected basal cell or squamous cell skin cancers, cervical cancer in situ, or resected colonic polyps
Chronic inflammatory disease that could impact erythropoiesis (for example, systemic lupus erythematosis, rheumatoid arthritis, celiac disease) even if it is currently in remission
History of other blood disorders
Active hemolysis or diagnosis of hemolytic syndrome
Known bone marrow fibrosis
Uncontrolled or symptomatic secondary hyperparathyroidism
History of alcohol or drug abuse within a year prior to randomization, or anticipated inability to avoid consumption of more than 3 alcoholic beverages per day
History of allergy or sensitivity to oral or IV iron therapy
Seizure disorder or receiving anti-epilepsy medication for seizure disorder within 12 weeks prior to randomization
Pregnant or breast-feeding females
Intervention: Etelcalcetide
Trial phase: Phase 2
ATC code: H05BX04
SMILES: CC(=O)N[C@H](CSSC[C@H](N)C(=O)O)C(=O)N[C@H](C)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](CCCNC(=N)N)C(=O)N[C@H](C)C(=O)N[C@H](CCCNC(=N)N)C(N)=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 37
Group description: Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
Eligibility criteria:
Inclusion Criteria:

Subjects provides written informed consent
Screening intact PTH (iPTH) ≥ 350 pg/mL and corrected calcium ≥ 8.5 mg/dL
Hemoglobin ≥ 8.5 g/dL
Serum transaminases (alanine transaminase [ALT], aspartate transaminase [AST]) less than 2.5 times the upper limit of normal
Adequate hemodialysis three times per week

Exclusion Criteria:

History or symptomatic ventricular dysrhythmias
History of angina pectoris or congestive heart failure
History of myocardial infarction, coronary angioplasty, or coronary artery bypass grafting within the past 6 months
History of or treatment for seizure disorder within the last 12 months
Postdialysis systolic blood pressure > 180 mmHg or diastolic blood pressure > 90 mmHg
Serum magnesium below the lower limit of normal at screening
Intervention: GLUTAMINE
Trial phase: Phase 2
ATC code: A16AA03
SMILES: NC(=O)CCC(N)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 106
Group description: Oral Glutamine Powder
Eligibility criteria:
Inclusion Criteria:

men and women age 18-72 years old who developed post-infectious diarrhea-predominant IBS (D-IBS)
increased intestinal permeability on Lactulose/Mannitol permeability test
able and willing to cooperate with the study
*absence of alcohol or NSAIDs ingestion for 2 weeks prior to inclusion into study and throughout the study duration

Exclusion Criteria:

current participation in another research protocol or unable to give informed consent
women with a positive urine pregnancy test or breastfeeding
history of inflammatory bowel disease, lactose intolerance, and/or celiac sprue
+ hydrogen breath test for bacterial overgrowth
+ antiendomysial antibody titer
use of nonsteroidal antinflammatory drug(NSAIDs) 2 weeks before or during the study
known allergy to glutamine
abdominal surgery except for removal of gallbladder, uterus, or appendix
Abnormal blood urea nitrogen(BUN) and/or creatinine