TrialPanorama/Dataset huggingface dataset:
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury
Brief Summary: The purpose of this study is to determine the effect of early administration of recombinant human erythropoietin on long-term neurological outcome after severe traumatic brain injury.


Options:
A: Inclusion Criteria:

* Severe traumatic brain injury (Glasgow coma scale \< 9), subarachnoid hemorrhage (Hunt and Hess scale ≥ 3) or intracranial hemorrhage
* Moderate anemia. Hemoglobin levels \> 7 g/dL and \< 10 g/dL
* Hemodynamical stability (mean arterial pressure \> 75 mm Hg)
* Respiratory stability (PaO2 / FiO2 ratio \> 220)
* Expected length of ICU stay \> 3 days

Exclusion Criteria:

* Patient's relatives' refusal to patient's inclusion in the study
* Active bleeding
* Ongoing need for blood products
* Patients necessitating ongoing resuscitation
* End-stage in which death is imminent
* Antecedents of angina or myocardial infarction (poor cardiopulmonary reserve)
* Deficient signal of rSO2 impeding its proper valuation
B: Inclusion Criteria:

* Blunt trauma mechanism of brain injury
* Glasgow Coma Score - motor component ≤ 5 (not following commands) on the post-resuscitation neurologic exam
* Available for enrollment and administration of study drug within 6 hours of injury

Exclusion Criteria:

* Penetrating trauma (i.e. gun shot wounds)
* Glasgow Coma Score = 3 and bilateral fixed and dilated pupils
* Abbreviated Injury Scale score \> 5 for any body part except brain
* Severe pre-existing chronic disease
* Uncontrolled hypertension, defined as mean arterial pressure \> 130mmHg despite antihypertensive treatment
* Known hypersensitivity to mammalian cell-derived products or human albumin
* Currently taking anticoagulants
C: Inclusion Criteria:

* Hemoglobin level \<10 g/dL during the first 72 hours of ICU

Exclusion Criteria:

* Acute bleeding
* Hemoglobin level less than 7 g/dL
D: Inclusion Criteria:

* Has undergone surgical repair for a hip fracture
* Has a postoperative Hgb level below 10 g/dL within three days of surgery
* Diagnosis of cardiovascular disease (e.g., coronary artery disease, congestive heart failure, stroke or transient ischemic attack, or peripheral vascular disease) or cardiovascular risk factors (e.g., diabetes mellitus, hypertension, hypercholesterolemia, tobacco use, or creatinine levels greater than 2.0 mg/dL)

Exclusion Criteria:

* Unable to walk prior to hip fracture
* Declines blood transfusions
* Suffered multiple traumas
* Pathologic fracture of the hip due to malignancy
* Clinically recognized acute myocardial infarction within the 30 days prior to study entry
* Previously participated in the trial and fractured the other hip
* Symptoms associated with anemia (e.g., ischemic chest pain) or actively bleeding at the time of randomization

Answer: B
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effects of Erythropoietin on Cerebral Vascular Dysfunction and Anemia in Traumatic Brain Injury
Brief Summary: The purpose of this study is to determine the effect of early administration of recombinant human erythropoietin on long-term neurological outcome after severe traumatic brain injury.


Options:
A: Inclusion Criteria:

* must have clinically significant symptoms of depression;
* must be current recipients of services at CBOCs associated with the Houston and Oklahoma City VAMCs.

Exclusion Criteria:

* cognitive impairment;
* presence of bipolar, psychotic or substance-abuse disorders.
* Veterans currently receiving psychotherapy WILL be excluded.
B: Inclusion Criteria:

* birthweight of less than 1250g
* admitted to participating NICU
* consent acquired from proxy for the patient

Exclusion Criteria:

* already received one or more transfusions
* requirement for an exchange transfusion
* will be receiving directed donations
* have rare blood types/difficult cross-match
* proxy has refused consent
* moribund on admission to NICU/expected to die
* mitigating child protection issues
C: Inclusion Criteria:

* Blunt trauma mechanism of brain injury
* Glasgow Coma Score - motor component ≤ 5 (not following commands) on the post-resuscitation neurologic exam
* Available for enrollment and administration of study drug within 6 hours of injury

Exclusion Criteria:

* Penetrating trauma (i.e. gun shot wounds)
* Glasgow Coma Score = 3 and bilateral fixed and dilated pupils
* Abbreviated Injury Scale score \> 5 for any body part except brain
* Severe pre-existing chronic disease
* Uncontrolled hypertension, defined as mean arterial pressure \> 130mmHg despite antihypertensive treatment
* Known hypersensitivity to mammalian cell-derived products or human albumin
* Currently taking anticoagulants
D: Inclusion Criteria:

* Patients, male or female, any race or ethnicity, age 18 years or older, in one of the seven adult critical care units of the Mayo Clinic, Rochester, with mechanically ventilated lungs, requiring elective transfusion of at least one unit of red cells

Exclusion Criteria:

* transfusion of any blood component within the previous 2 hours, emergency transfusion or hemodynamic instability defined by other than a stable dose of vasoactive medications.

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Back-to Back Trial of Narrow Band Imaging (NBI) With Magnification Versus Standard Colonoscopy for Colonic Neoplasia Surveillance in Hereditary Non-Polyposis Colorectal Cancer (HNPCC) Patients
Brief Summary: The purpose of this study is to determine whether a new colonoscopic viewing technique called narrow band imaging (NBI)can help doctors detect more patients with at least one pre-cancerous area than conventional colonoscopy using white light alone in patients with genetically inherited high risk for bowel cancer (HNPCC).


Options:
A: Inclusion Criteria:

* referred for elective outpatient colonoscopy

Exclusion Criteria:

* known inflammatory bowel disease
* personal or family history of polyposis syndrome
* referral for resection of a known lesion
B: Inclusion Criteria:

* Asymptomatic persons \> 55 years willing to undergo screening colonoscopy

Exclusion Criteria:

* Missing consent
* Symptomatic persons
* Poor general conditions, significant comorbidity
C: Inclusion criteria:

* referral for screening or surveillance colonoscopy
* the ability to provide informed consent

Exclusion criteria:

* prior surgical resection of any portion of colon
* prior history of colon cancer
* history of inflammatory bowel disease
* use of anti-platelet agents or anticoagulants that precludes removal of polyps during the procedure
* poor general condition or any other reason to avoid prolonged procedure time
* history of polyposis syndrome or HNPCC
* inability to give informed consent.
* Inadequate bowel preparation
D: Inclusion Criteria:

* patients with HNPCC according to the Amsterdam II criteria
* patients over 18 years

Exclusion Criteria:

* pregnant patients
* unable or unwilling to give consent

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.
Brief Summary: The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.


Options:
A: Inclusion Criteria:

* diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

Exclusion Criteria:

* psychiatric illness,
* depression,
* suicidal risk,
* substance abuse,
* pulmonary dysfunction,
* renal impairment,
* active cardiac disease,
* liver disease,
* autoimmune disease,
* cancer,
* inflammatory bowel disease
B: Inclusion Criteria:

* Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites.
* Patients must have a score of \>40 mm on the Visual Analog Scale

Exclusion Criteria:

* Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders.
C: Inclusion Criteria:

* Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

Exclusion Criteria:

* Psychiatric illness
* Depression
* Suicidal risk
* Substance abuse
* Pulmonary dysfunction
* Renal impairment
* Active cardiac disease
* Liver disease
* Autoimmune disease
* Cancer
* Sleep apnea
* Inflammatory bowel disease
D: Inclusion Criteria:

* Patients who met the American College of Rheumatology (ACR) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
* Patients who completed at least 4 pain diaries within the last 7 days and the average pain score must have been ≥4, and had a score of ≥40 mm on the Visual Analogue Scale (VAS) of the SF-MPQ at screening (Visit 1) and randomization (Visit 2)

Exclusion Criteria:

* Patients with other severe pain that may confound assessment or self-evaluation of the pain associated with fibromyalgia
* Patients with any inflammatory muscle or rheumatologic disease other than fibromyalgia, active infections, or untreated endocrine disorders
* Patients with severe depression

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multi-National, Multi-Center, Double-Blind, Randomized, Parallel Group Study to Compare the Safety and Efficacy of 200 mg PAR-101 Taken q12h With 125 mg Vancomycin Taken q6h for Ten Days in Subjects With Clostridium Difficile-Associated Diarrhea
Brief Summary: This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).


Options:
A: Inclusion Criteria:

* Males/females with CDAD
* Females must use adequate contraception
* Signed informed consent

Exclusion Criteria:

* Life-threatening CDAD
* Toxic megacolon
* Pregnant
* Concurrent use of diarrheal agents
* Participation in other trials
B: Key Inclusion Criteria:

* Male or female
* At least 18 years of age
* With a diagnosis of Clostridium Difficile-associated diarrhea (CDAD): first occurrence or first recurrence.

Key Exclusion Criteria:

* Concurrent life threatening condition.
* Immuno-compromised subjects, concomittant immuno-suppresive treatment.
* Concomitant antimicrobial treatment for CDAD.
* Any circumstances or conditions, which, in the opinion of the investigator, would affect full participation of the subject in the study or compliance with the protocol
C: Inclusion Criteria:

* 18 years of age
* The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
* Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD
* Baseline serum potassium \> 3.0 mmol (meq)/L
* Patient considered sufficiently stable clinically to likely complete a 6 week study period
D: Inclusion Criteria:

* Adult of either gender, 18 years or older with a first episode of C. difficile infection
* Meets the case definition of C. difficile infection-diarrhea associated with a positive stool test for C. difficile toxin(s) in the 2 days prior to enrollment treated with metronidazole or vancomycin

Exclusion Criteria:

* Severe disease defined as any of the following: WBC \> 30,000 or \< 1000 cells/mm\^3, elevated creatinine \> 1.5 times the premorbid level, ICU patient at time C. difficile infection diagnosed
* Has other known etiology of diarrhea (e.g. other enteric pathogen, other intestinal disease)
* Has a history of chronic intestinal disease (e.g. Crohn's disease, ulcerative colitis)
* Has a presence of toxic megacolon or ileus
* Has a presence of colostomy or nasogastric tube
* Has a history of abdominal surgery within the previous 3 months (from time of enrollment)
* Is enrolled in another investigational drug trial
* Is unavailable for follow-up visits
* History of multiple C. difficile infection
* Willing not to take other probiotics for duration of study
* Is severely immunocompromised.

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Patient-Centered Implementation of Elective Single Embryo Transfer (eSET) in in Vitro Fertilisation (IVF) and Intracytoplasmic Sperm Injection (ICSI)
Brief Summary: Background: The number of multiple pregnancies is considered to be the most important adverse effect of in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). IVF or ICSI with transferring only one embryo, elective single embryo transfer (eSET), will reduce this incidence remarkably. Unfortunately, former research has documented that cycles with SET maintain lower pregnancy rates compared to double embryo transfer (DET). Implementation of eSET will require a carefully chosen and thoroughly defined implementation strategy focussed on the couple undergoing the subfertility treatment. This trial will investigate the (cost)effectiveness of a combined patient centred implementation strategy.

Objective: The main aim is to compare the effectiveness and costs of implementation of elective single embryo transfer (eSET) in in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI), between usual care and a combined patient-centred strategy.

Study design: A randomised controlled trial

Study population: Couples with a female age less than 40 years ongoing an IVF/ICSI treatment in 2 of the 13 Dutch IVF centres and their 4 satellite/transport centres.

Intervention A combined patient centred implementation strategy for eSET in IVF/ICSI. The strategy consists of counselling through an evidence based decision aid and reimbursement of a 4th cycle if couples have chosen for eSET in the first 2 cycles.

Primary study parameters/outcome of the study: the eSET occurrence rate, pregnancy outcomes and cost-effectiveness of the combined strategy.

Secondary study parameters/outcome of the study:

* patient knowledge
* patient decisional conflict
* patient satisfaction
* IVF/ICSI treatment outcome.


Options:
A: Inclusion Criteria:

* Ages 40-80 years
* Their physician agreed to participate in the study
* Seen in practice for at least one year

Exclusion Criteria:

* Prior history of prostate cancer
* Presenting for acute medical visit
* Non-skin cancer
* Lung disease requiring oxygen
* Renal failure requiring dialysis
* Intensive care visit in last 6 months
* Need assistance with activities of daily living
B: Inclusion Criteria:

* \>18 years old
* English or Spanish speaking
* Presence of coronary disease, or a caregiver/relative of one with coronary disease

Exclusion Criteria:

* non-English or non-Spanish speaking
* dementia
C: Inclusion:

* Commercially-insured beneficiaries
* Receive all medical/prescription drug benefits through Horizon
* On ≥1 one oral hypoglycemic agent
* Latest HbA1c measurement ≥ 8% (within previous 6 months)
* Provided phone number to Horizon

Exclusion:

- Currently using any insulin
D: Inclusion Criteria:

* Female age \< 39 years
* In first cycle minimum of two embryos available for transfer

Exclusion Criteria:

* Medical necessity for single embryo transfer

Answer: D
Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Trial Comparing Near Versus Distance Activities While Patching for Amblyopia in Children 3 to <7 Years Old
Brief Summary: Ths purpose of this study is to determine whether "near" activities enhance the effect of patching on visual acuity improvement in strabismic and anisometropic amblyopia when compared with "distance" activities in the treatment of moderate amblyopia and severe amblyopia in children 3 to \<7 years old.


Options:
A: Inclusion Criteria:

* Patients must be 3 to less than 7 years old with amblyopia due to strabismus, anisometropia, or both.
* Visual acuity in the amblyopic eye must be between 20/40 and 20/400 inclusive, visual acuity in the sound eye 20/40 or better and inter-eye acuity difference \> 3 logMAR lines.
* Spectacles, if needed, must be worn for at least 16 weeks or until visual acuity documented to be stable.

Exclusion Criteria:

* Prior amblyopia treatment other than spectacles in the past month.
* More than one month of amblyopia treatment in the past 6 months.
B: Inclusion Criteria:

* Age 7 to 12 years old (inclusive)
* Amblyopia associated with strabismus, anisometropia, or both
* Visual acuity in the amblyopic eye 19 to 71 letters on Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS©) (20/40 to 20/400 inclusive)
* Visual acuity in the sound eye 79 letters or better on E-ETDRS© (20/25 or better)
* Interocular difference \>=15 letters (3 lines)
* Spectacles, if needed, worn for at least 16 weeks or visual acuity documented to be stable

Inclusion Criteria for Optional Ancillary Study:

* Enrolled into the main study
* Refractive error in both eyes between -0.25 and +5.00D, inclusive (to avoid the need to adjust for refractive error)
* Birth weight \>1500 grams
* No history of Central Nervous System (CNS) disease (e.g. intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), meningitis, developmental abnormalities of the brain, hydrocephalus, cerebral palsy, hypoxic ischemic encephalopathy

Exclusion Criteria:

* Amblyopia treatment (other than spectacles) in the last 6 months
* Myopia (more than -0.25D spherical equivalent) in either eye
C: Inclusion Criteria:

* Patients must be aged 7 to \<18 years and have amblyopia associated with strabismus, anisometropia, or both.
* Visual acuity in the amblyopic eye must be 20/40 to 20/400 inclusive and visual acuity in the sound eye must be 20/25 or better.

Exclusion Criteria:

* Patients must not have received amblyopia treatment (other than spectacles) in the past month or more than one month of amblyopia treatment in the last 6 months.
D: Inclusion Criteria:

* Patients must be 7 years old or younger with amblyopia due to strabismus or anisometropia
* Visual acuity in the amblyopic eye must be between 20/40 and 20/100
* Visual acuity in the sound eye or 20/40 or better
* At least 3 lines of acuity difference between the two eyes

Exclusion Criteria:

* More than two months of amblyopia therapy in the past two years
* Myopia (more than -0.50 D)

Answer: A
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Decision Aid to Improve Coronary Heart Disease Risk Modification: a Pilot Randomized Trial
Brief Summary: The purpose of this study is to determine whether providing patients with information about their global coronary heart disease (CHD) risk and effective risk-reducing strategies allows them to make appropriate decisions about heart disease prevention.


Options:
A: * Have a diagnosis of type 2 diabetes mellitus of any duration; c-peptide test not required
* Use 1 or 2 oral hypoglycemic agents; not using insulin therapy
* Are not pregnant
* Have stable but inadequate glycemic control: both A1C at the time of eligibility and previous A1c within 6 months between 7-9.5%
* Recognize their primary care provider as their main diabetes care provider
* Do not have major barriers (i.e., severe hearing impairment, dementia, cannot communicate in English) to participate in shared decision-making (per provider?s assessment)
* Have no plans to relocate out of town in the next 6 months
* Enrolment is open to males and females of diverse racial backgrounds
B: Inclusion Criteria:

* Referred for consideration of an ICD(non-CRT)for a primary prevention indication
* English speaking
* able to provide informed consent

Exclusion Criteria:

* unable to understand the decision aid due to a language barrier or visual impairment
* referred for secondary prevention indication
C: Inclusion Criteria:

* presenting for routine medical care with regular medical provider
* able to understand, speak, and read English

Exclusion Criteria:

* prior history of cardiovascular disease
* history of serious medical illness that would limit candidacy for screening
* previous participation in intensive risk modification as part of diabetes study in our clinic
* no cholesterol measurement in the last 3 years, limiting ability to provide up-to-date risk estimate
D: Inclusion Criteria:

* Over 64

Exclusion Criteria:

* Can't speak English

Answer: C
Please select the eligibility criteria that correspond to the clinical trial below.
Title: Decision Aid to Improve Coronary Heart Disease Risk Modification: a Pilot Randomized Trial
Brief Summary: The purpose of this study is to determine whether providing patients with information about their global coronary heart disease (CHD) risk and effective risk-reducing strategies allows them to make appropriate decisions about heart disease prevention.


Options:
A: Inclusion Criteria:

* presenting for routine medical care with regular medical provider
* able to understand, speak, and read English

Exclusion Criteria:

* prior history of cardiovascular disease
* history of serious medical illness that would limit candidacy for screening
* previous participation in intensive risk modification as part of diabetes study in our clinic
* no cholesterol measurement in the last 3 years, limiting ability to provide up-to-date risk estimate
B: Inclusion Criteria:

* Enrolled at Minneapolis VAMC
* Type 1 or 2 diabetes
* Blood pressure at screening visit \> 140mmHg systolic or \> 90mmHg diastolic OR HgbA1C at screening visit \> 9.0% OR LDL at screening visit \> 100mg/dL

Exclusion Criteria:

* Primary care provider unwilling to have participant included in study
* Life expectancy \< 1 year
* Unable to give consent
* Severe mental health condition
* pregnant or planning on becoming pregnant
C: Inclusion Criteria:

* Age 30 years and above
* Personal history of heart attack or stroke
* Presence of other cardiovascular risk factors such as smoking, overweight, diabetes

Exclusion Criteria:

* Mental disability
* Not living in the Study area
D: Inclusion Criteria:

* all citizens living in Randers Municipality aged 30-49 on 1 January 2012, identified in the Danish Civil Registers (DCR) and randomised for health check in 2013 or 2017.

Exclusion Criteria:

* Terminal illness, reported by their GP is exclusion criteria for receiving invitation.

Answer: A