TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
Brief Summary: A 9-week randomized double-blind, multi-center study of 172 patients, who after 1 week baseline evaluation are randomized to either fixed dose pregabalin starting at 75 mg BID for one week and increased to 150 mg BID for 7 weeks or flexibly dosed pregabalin given BID (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks.It is proposed that use of flexible dosing combined with nightly dosing would have similar pain relief to fixed dosing, would improve adherence, would have less side effects and would be more likely to improve sleep.


Options:
A: Inclusion Criteria:

* Subjects must meet diagnostic criteria for fibromyalgia;
* Subjects must report difficulty in maintaining sleep at least 3 times per week and meet Research Diagnostic Criteria (RDC) for insomnia disorder, corroborated by subject diary, and meet PSG inclusion criteria at visit 3.

Exclusion Criteria:

* History of active sleep disorder other than Research Diagnostic Criteria(RDC) insomnia criteria or any sleep or circadian rhythm disturbance;
* Use of medications known to affect sleep wake function by Visit 2;
* Involved in night or rotating shift work, or travel across \>4 time zones 14 days prior to screening and during study; regular daytime napping
* PSG finding of apnea/hypopnea or periodic limb movement with arousal index \>10/hr on either night of PSG.
B: Inclusion Criteria:

* ACR criteria for fibromyalgia
* A score of more or equal to 40 mm on the Pain Visual Analog Scale (VAS) and a an average score more or equal to 4 on 4 daily pain diaries

Exclusion Criteria:

* Patients with other severe pain conditions
* Patients with severe depression
* Patients taking excluded medications
C: Inclusion Criteria:

* diagnosis of fibromyalgia by ACR criteria
* ambulatory patients
* complete of 5 pain diaries during 1 week evaluation
* other inclusion criteria may apply

Exclusion Criteria:

* pregnant or of childbearing potential not using contraceptives
* use of pregabalin in the past
* concomitant use of opioids or gabapentin
* estimated creatinine clearance less than 60
* other criteria may apply
D: Inclusion Criteria:

* Clinical diagnosis of primary osteoarthritis of the knee(s)
* Presently receiving prescribed oral or topical analgesics for a minimum duration of two weeks prior to enrollment

Exclusion Criteria:

* Arthritis other than primary osteoarthritis
* Treatment with disease-modifying antirheumatic drugs (DMARDS), methotrexate or biologics
* Subtotal or total joint replacement in the affected knee
* Chronic severe pain of other causes that in the opinion of the investigator may require long-term analgesia or confound the present study
* Currently enrolled in a clinical trial or who have participated in a clinical trial within the past 30 days

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of Slow Efficiency Daily Dialysis (SLEDD) With Unfractionated Heparin Versus Citrasate in Critically Ill Patients.
Brief Summary: The purpose of this study is to compare the feasibility, safety and efficacy of hemodialysis with unfractionated heparin compared to hemodialysis with Citrasate in Critically Ill Patients.


Options:
A: Inclusion Criteria:

* Patients who were admitted to the intensive care unit and required CRRT

  1. active bleeding such as gastrointestinal bleeding and intracranial hemorrhage,
  2. activated partial thromboplastin time \> 60 s,
  3. prothrombin time-international normalized ratio \> 2.0,
  4. thrombocytopenia (\<100,000/µL), and
  5. surgery within 48 h before CRRT.

Exclusion Criteria:

* Pregnant or possibly pregnant women
* Patients who were allergic to nafamostat mesilate
* Patients who were hypercoagulable
B: Inclusion Criteria:

* Systemic inflammatory response syndrome; SIRS \> or = 2 meets definition
* Patients with acute kidney injury in the intensive care ward.
* Requiring continuous renal replacement therapy.

Exclusion Criteria:

* Pregnancy
* Cirrhosis
* End stage renal disease
* HIV infection
* Serum creatinine in male \> 2 mg/dl and female \> 1.5 mg/dl
* Bleeding
C: Inclusion Criteria:

* patients who have at least one of the hemorrhagic tendencies of following conditions and needs CRRT hemodynamically;

  1. Platelet count \< 100,000
  2. aPTT \> 60 sec
  3. PT-INR \> 2.0
  4. active hemorrhage
  5. surgery within 48 hours
  6. cerebral hemorrhage within 3 months or history of major bleeding
  7. septic shock or DIC.

Exclusion Criteria:

* pregnancy, breast feeding, possibility of pregnancy,
* allergy to nafamostat mesilate,
* other conditions that physician consider unfit for candidate.
D: Inclusion Criteria:

* Need for hemodialysis in the ICU for at least one treatment
* No prior hemodialysis treatment in the ICU except continuous renal replacement therapy

Exclusion Criteria:

* Need for systemic anticoagulation with unfractionated or fractionated heparin, oral anticoagulants or intravenous anti-aggregants for other reasons
* Need for continued thrombolysis therapy within the 6 hours before inclusion
* Need for continued treatment with activated protein C (drotrecogin alfa) within the 12 hours before inclusion
* Need for continued treatment with intravenous anti-aggregants (abciximab, eptifabide) within 12 hours before inclusion
* Liver failure (acute and acute-on-chronic)
* Confirmed or suspected Heparin Induced Thrombocytopenia (HIT)
* Heparin allergies
* Severe uncorrected hypocalcemia (ionized calcium \< 0,8 mmol/l)
* Refusal of informed consent

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Comparison of Slow Efficiency Daily Dialysis (SLEDD) With Unfractionated Heparin Versus Citrasate in Critically Ill Patients.
Brief Summary: The purpose of this study is to compare the feasibility, safety and efficacy of hemodialysis with unfractionated heparin compared to hemodialysis with Citrasate in Critically Ill Patients.


Options:
A: Inclusion Criteria:

* Critically ill patients requiring CRRT for AKI (RIFLE criteria)
* Written informed consent from the patient or legal representative

Exclusion Criteria:

* pre-existing chronic renal insufficiency requiring dialysis
* chronic immunosuppression
* liver cirrhosis Child-Pugh C
* severe or shock-related hepatitis
* Pregnancy
B: Inclusion Criteria:

* Thrombocytopenia suspicious for HIT with decrease in platelet count \>50% from baseline obtained at hospital admission
* 4 T´s score for HIT probability \>3 AND/OR positive ELISA for HIT
* Age ≥18 years
* Informed consent (if applicable)

Exclusion Criteria:

* Transient thrombocytopenia due to intraoperative bleeding
* Active bleeding
* Intracranial operations
* Liver dysfunction with spontaneous aPTT\> 60 sec.
* History of adverse events or sensitivity against study drugs
* Pregnancy
* Age\<18 years
* Preexisting psychiatric/neurologic disorders with long-term inability to provide informed consent
C: Inclusion Criteria:

* Need for hemodialysis in the ICU for at least one treatment
* No prior hemodialysis treatment in the ICU except continuous renal replacement therapy

Exclusion Criteria:

* Need for systemic anticoagulation with unfractionated or fractionated heparin, oral anticoagulants or intravenous anti-aggregants for other reasons
* Need for continued thrombolysis therapy within the 6 hours before inclusion
* Need for continued treatment with activated protein C (drotrecogin alfa) within the 12 hours before inclusion
* Need for continued treatment with intravenous anti-aggregants (abciximab, eptifabide) within 12 hours before inclusion
* Liver failure (acute and acute-on-chronic)
* Confirmed or suspected Heparin Induced Thrombocytopenia (HIT)
* Heparin allergies
* Severe uncorrected hypocalcemia (ionized calcium \< 0,8 mmol/l)
* Refusal of informed consent
D: Inclusion Criteria:

* critically patients ill patients with acute kidney failure (AKI) needing renal replacement therapy

Exclusion Criteria:

* therapy with aspirin or other non-steroidal anti-inflammatory drugs in the previous 7 days
* concomitant treatment with other extracorporeal organ-assist devices any other drug affecting coagulation or platelets

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress Incontinence (SITOT)
Brief Summary: Aim: The study aim to assess the feasibly a large prospective multi-centre randomised study for comparing the relatively new "Single incision sub-urethral tapes" with the standard surgical treatment of female urodynamic stress incontinence (USI).


Options:
A: Inclusion Criteria:

* USI
* Mixed incontinence symptoms with predominantly bothering stress component (No DO on UDS).
* Primary Incontinence Surgery.
* BMI \< 35
* Ability to understand the information leaflet and sign an informed consent form in English.
* All would have had failed or declined PFMT.

Exclusion Criteria:

* Mixed incontinence with pre-dominant OAB and/or Neurological conditions e.g. MS.
* Detrusor Overactivity on Urodynamics.
* Inability to understand English.
* Un-willing for randomisation.
* Concomitant surgery.
* Patient requiring postoperative hospital-stay for medical or social reasons
B: Inclusion Criteria:

* Clinical and urodynamic for stress urinary

Exclusion Criteria:

* Detrusor overactivity (urodynamic study)
* Urodynamic changes suggesting reduced vesical capacity
* Associated neurological diseases
* Coagulopathies
* Pregnancy
* Foreign matter sensitiveness history
* Acute urinary tract infection
* Sequel from high ionizing radiation exposure
* Use of drugs that may result in high surgical risk and/or significant postoperative complication
* Anesthetic procedure contraindication
* Vulvovaginitis: presence of vaginal secretion with infection clinically or lab supported
C: Inclusion Criteria:

* Stress urinary incontinence with urethral hypermobility.

Exclusion Criteria:

* Incapacity to understand the information or give their consent.
* Previous anti-incontinence surgery with slings.
* Urethral hypomobility (Q-tip test \<30º).
* Low pressure urethra (MUCP \< 20cmH2O).
* Detrusor overactivity.
D: Inclusion Criteria:

* Female patients with symptoms of stress urinary incontinence and a positive cough test who require surgical management. Cough test is positive when leakage of urine is seen from the urethra synchronously with the patient performing a cough or valsalva manuver with a comfortably full bladder in the lying or standing position.

Exclusion Criteria:

* Women with predominantly symptoms of urge urinary incontinence
* Presence of prolapse greater than Pelvic organ prolapse quantification (POPQ) Stage 1 or prolapse requiring surgery
* Detrusor overactivity on cystometrogram at urodynamic testing
* Previous surgery for incontinence
* Intrinsic sphincter deficiency (MUCP\<20 cm H2O or Q -tip \<30o)
* Voiding dysfunction with postvoid residual \>100 cc

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Open, Randomized, Crossover Phase 2 Pilot Study of Treatment of Stage 3B Renal Failure With Active Vitamin D or a Phosphate Binder to Evaluate the Effect on the FGF23 and PTH Levels.
Brief Summary: Patients with reduced renal function normally develop hyperparathyroidism, which in turn is associated with increased cardiovascular risk and de-calcification. Hyperparathyroidism may be enhanced by an increased level of FGF23 which is often seen in the early stage of renal failure. This pilot study will investigate the FGF23-lowering effect of early initiation of treatment with a phosphate binder versus active vitamin D in an open crossover design.


Options:
A: Inclusion Criteria:

* Chronic kidney disease patients aged 18 to 80 years
* Chronic kidney disease stage 3 (defined as a glomerular filtration rate of 30-60 ml/min/1.73m2)
* Office blood pressure controlled to less than 140/90 mmHg for 12 months before entry into the study
* Total cholesterol less than 5.5 mmol/l

Exclusion Criteria:

* Existing or previous treatment within 1 year with a phosphate binder or vitamin D analogue
* Uncontrolled hyperphosphataemia (serum phosphate \>1.8 mmol/l)
* Uncontrolled secondary hyperparathyroidism (PTH \>80 pg/ml)
* Diabetes mellitus
* Pregnancy
* Moderate-severe cardiac valvular disease
B: Inclusion Criteria:

* Renal failure stage 3B
* 25(OH)vitamin D level above 50 nmol/l
* Age over 18 years
* Written consent

Exclusion Criteria:

* Major surgery during the previous 6 months
* Myocardial infarct during the previous 6 months
* Unstable heart failure
* Ongoing treatment for any malignancy
* History of frequent infections
* Pregnancy
* Ongoing treatment with steroids, lithium or biphosphonates
C: Inclusion Criteria:

* Subjects who have completed treatment in Protocol PA-CL-05A
* Written Informed Consent

Exclusion Criteria:

* Hyper/hypo calcemia; hyper intact parathyroid hormone (iPTH)
* Other significant medical conditions
* Pregnancy
D: Inclusion Criteria:

* Males or females aged between 18-70 years old
* Subject with hyperphosphatemia (5.5 - 8.5 mg/dL) at both WK(-2) and WK0
* On stable TIW hemodialysis for 3 months or longer

Exclusion Criteria:

* Patients with hypercalcemia (corrected serum calcium \> 10.5 mg/dL)
* Any of the following abnormalities: ALT or AST \> 3X ULN; iPTH \> 1000 or \< 150 pg/mL
* History of dysphagia or swallowing disorders
* History of GI motility disorder or GI bleeding within 3 months prior to entry

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Antioxidant Supplementation in Pregnant Women With Low Antioxidant Status
Brief Summary: The purpose of this study is to investigate the benefit of several micro nutrients of antioxidants (using milk) in a cohort of women with low antioxidant status and the changes in cell-free mRNA.


Options:
A: Inclusion Criteria:

* Married women of reproductive age identified as a new pregnancy using a urine test

Exclusion Criteria:

* Menopausal or sterilized woman or currently already pregnant or breastfeeding an infant \<9 months of age
B: Inclusion criteria:

* Willing to participate in the study and filling out the informed consent form,
* History of 3 or more idiopathic abortion,
* the last abortion should be more than 6 months ago,
* no history of consumption of folate supplements or high folate containing foods during last 6 months,
* All previous abortions should be idiopathic without any anatomic, cytologic, hormonal, septic pathologic finding,
* no special diets

Exclusion Criteria:

* elective or induced abortion, molar or ectopic pregnancies,
* presence of any malignancy, chromosomal abnormality, uterine abnormality, Thyroid, kidney, or liver dysfunction, Glucose intolerance, seizure,
* Alcohol or drug abuse,
* Taking any drug affecting homocystein metabolism,
* not following the study protocol.
C: Inclusion Criteria:

* pregnant women with 8-12 weeks of gestation

Exclusion Criteria:

* known multiple pregnancy
* known fetal anomaly
* known thrombophilia
* known infections and mola hydatidosa
* chronic renal failure
* uncontrolled hypertension
* known placental abnormalities
* documented uterine bleeding within a week of screening
* uterine malformation
* history of medical and metabolic complication such as heart disease or diabetes
D: Inclusion Criteria:

* HIV negative
* 12-26 weeks gestational age at screening visit

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Brief Nursing Intervention to Prevent Poor Psychosocial Outcomes in Living Donors
Brief Summary: The purpose of this study is to evaluate the potential effectiveness of a psychosocial intervention based on the principles of motivational interviewing. The novel intervention will assist living donor candidates to think through any remaining concerns or questions that they may have about living donation. If the intervention is effective, it may help to prevent post-donation problems related to psychological and health outcomes.


Options:
A: Inclusion/Exclusion Criteria for Patients

Inclusion Criteria:

* Patients that visited a family physician
* Patients that are at least 16 years of age with a valid health card (eligibility criteria to register for organ donation in Ontario)

Inclusion/Exclusion Criteria for Family Physicians (Cluster level)

Inclusion Criteria:

- Working at a site that sees at least 100 patients per week

Exclusion Criteria:

- Working at multiple sites that cannot be separated in analyses
B: Inclusion Criteria:

* Adults (age ≥ 18 years)
* Hispanics/Latinos
* ESRD patients who are scheduled to attend each participating transplant center's education sessions. Sessions mark the first phase of evaluation in order for patients to get wait listed for a transplant or for others to become a living kidney donor.
* Family and friends who accompany patients to the transplant center.
* Identification as Hispanic/Latino.
* Ability to come to Northwestern 3 hours prior to the scheduled education session.
* Ability to read. Reading ability will be assessed using the 5-point Likert scale question validated in English and Spanish:13 "How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?" People will be included if they reply 1-Never or 2-Rarely.

Exclusion Criteria:

* Non-identification as Hispanic/Latino.
* Inability to come to Northwestern 3 hours prior to the scheduled education session.
* Individuals who are not able to read Spanish or English. People will be excluded if they reply 3-Sometimes, 4-Often, and 5-Always to the question, "How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?" .
C: Inclusion Criteria:

* English speaking
* Applying for driver's license, driver's permit or state id

Exclusion Criteria:

* Non-English speaking
* Persons who have already signed donor card
D: Inclusion Criteria:

* Score of 1 or greater on the Simmons Ambivalence Scale;
* Must be able to speak English;
* Have been evaluated as a potential living kidney or liver donor candidate;
* Aged 18 or older

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Electronic Medical Records to Improve Patient & Public Health in Rural Kenya
Brief Summary: Computer-generated clinical reminders offered to providers will improve compliance with care guidelines and impact outcomes in resource-limited clinics.


Options:
A: Inclusion Criteria:

* Admitted with STEMI to a hospital in LHIN IV, coronary angiogram with and without PCI at Hamilton General Hospital during hospital admission

Exclusion Criteria:

* Non-english speaking
B: Inclusion Criteria:

* Not up to date on CRCS
* Continuously enrolled in Group Health Cooperative (GHC) for 24 months
* Expected to continue to be enrolled at GHC for 24 months.

Exclusion Criteria:

* Known high risk for CRC
* History of CRC
* History of inflammatory bowel disease
* Current anticoagulation therapy
* Organ failure
* Serious illness
* Debilitating disease
* Dementia
* Nursing home resident.
C: Inclusion Criteria:

* Alberta residents who undergo a cardiac catheterization and are diagnosed with coronary artery disease (\> or equal to 50% stenosis in at least one vessel).

Exclusion Criteria:

* no fasting lipid panel within the previous 6 weeks
* on a statin at maximal dose
* on a statin/lipid lowering drug and LDL-C is 2.5 mmol/L or less (prior to Sept 2006) and LDL-C is 2.0 mmol/L or less (after Sept 2006)
* not on a statin and LDL-C is 1.8 mmol/L or less
* acute myocardial infarction or cardiogenic shock
* require emergency bypass surgery following catheterization
* contraindication to statins (e.g. cirrhosis, inflammatory muscle disease)
D: Inclusion Criteria:

* All pregnant women, children born to HIV+ mothers, and TB/HIV co-infected patients visiting these clinics during the this study will be included.

Exclusion Criteria:

-

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Does Advisory Support to Prolong the Breast-feeding Period Reduce the Risk for Obesity and Metabolic Dysfunction in Infants of Obese Mothers ?
Brief Summary: 0-hypothesis: advisory support does not

1. prolong the the breast-feeding period
2. minimize the risk of obesity and metabolic dysfunction in infants of obese mothers


Options:
A: Inclusion Criteria:

Healthy, term infants Informed and written consent obtained from both parents -

Exclusion Criteria:

Sick infants Preterm infants No consent

-
B: Inclusion Criteria:

* own a smart phone;
* 18 years or above;
* sufficient language skills (completed secondary school education);
* carry a singleton fetus;
* at a gestational age of 28 to 30 weeks;

Exclusion Criteria:

* have existing medical conditions or pregnancy complications which may inhibit breastfeeding initiation, according to their medical doctor;
* intend to give birth in health institutes other than the study hospitals.
C: Inclusion Criteria:

* 18 years of age or older;
* Currently pregnant;
* Living in the Pico/Union Koreatown community;
* Ability to provide informed consent;
* Speaks English or Spanish

Exclusion Criteria:

* Under 18 years of age;
* Not currently pregnant;
* Not living in the Pico/Union Koreatown community;
* Unable to provide informed consent;
* Does not speak English or Spanish
D: Inclusion Criteria for mothers:

1. ≥ 18 years;
2. Initiated breastfeeding while in the hospital and intend to breastfeed post-discharge
3. Fluent in English

Inclusion criteria for infants:

1. Infants must be term or near term (\>35 weeks gestational age)
2. Not require a stay in the neonatal intensive care unit

Exclusion Criteria:

1. Prisoners, incarcerated individuals, detainees, parolees, probationers will be excluded because there may external circumstances outside of their control that may prevent continuous breastfeeding.
2. Mothers and infants will be excluded if they have maternal, fetal, or neonatal conditions or complications with the potential to physiologically compromise breastfeeding or milk supply (e.g., infant cardiac defects, post-partum infant ventilator dependence), and or contraindications to breastfeeding as specified by the American Academy of Pediatrics (e.g., HIV+ status).

Answer: A