Kornimate/medical-research-clean huggingface dataset:
remote ischaemic preconditioning for heart surgery (ripheart-study)

Conditions: Myocardial Injury; Mortality

Summary: the purpose of this study is to evaluate the effects of remote ischaemic preconditioning on perioperative ischaemic injury in patients undergoing cardiac surgery compared to control intervention.

cardiac surgery with cardiopulmonary bypass is associated with a predictable incidence of myocardial, neurological and renal dysfunction. this significant morbidity and mortality is at least partly due to perioperative ischaemia. remote ischaemic preconditioning (ripc) is a novel, simple, non-invasive and inexpensive intervention by which ischaemia of non-vital tissue (skeletal muscles) protects remote organs (heart, brain and kidney) from a subsequent sustained episode of ischaemia. the investigators perform a multicenter randomized controlled study to evaluate that ripc reduces teh severity of perioperative ischaemic injury in patients undergoing cardiac surgery, and results in about 1/3 risk reduction in the occurence of major adverse events.

Eligibility criteria:
inclusion criteria: * patients undergoing heart surgery on cardiopulmonary bypass exclusion criteria: * age \< 18 * emergency cases * left ventricular ejection fraction less than 30% * current atrial fibrillation * inability to give informed consent * preoperative use of inotropics or mechanical assist device * severe liver, renal and pulmonary disease * recent myocardial infarction (within 7 days) * recent systemic infection or sepsis (within 7 days) * severe stroke (within 2 months) * peripheral vascular disease affecting upper limbs * previous serious psychiatric disorders (e.g. schizophrenia, dementia) * concomitant carotid endarterectomy * rare surgeries: cardiac transplantation, correction of complicated congenital anomalies, pulmonary thromboembolectomy, off-pump surgery, minimal-invasive operation without sternotomy

Keywords: remote ischaemic preconditioning, cardiac surgery
efalizumab for eczema

Conditions: Dermatitis, Atopic

Summary: the purpose of this study is to demonstrate a measurable improvement on a validated scale in a small population of adult patients with atopic dermatitis (eczema).

the study involves administration of efalizumab (previously approved for psoriasis) to ten adult patients with atopic dermatitis. biologic plausibility rests on similarities in pathophysiology of the two conditions. the drug (efalizumab) will be administered according to the dosing approved for plaque psoriasis for a period of 24 weeks. the subjects will self-administer efalizumab weekly and measurements will be performed on a monthly basis. efalizumab is not being compared to placebo or other drugs.

Eligibility criteria:
inclusion criteria: * adults (18 years or older) with atopic dermatitis with 5% or more body surface area involvement * investigator global assessment (iga) score of "moderate" or worse * in general good health with well-controlled medical problems * ability to provide written informed consent and comply with study assessments for the full duration of the study. * if a female of childbearing potential, a negative pregnancy test and commitment to the use of two forms of effective contraception (birth control) for the duration of the study are necessary. * if a non-sterile male, commitment to the use of two forms of effective contraception (birth control) for the duration of the study is necessary. * normal platelet count exclusion criteria: * patients with known hypersensitivity to efalizumab or any of its components * pregnancy or lactation * patients receiving immunosuppressive agents * prior enrollment in the study * participation in another simultaneous medical investigation or trial * iga score of "mild," "almost clear" or "clear" * systemic therapy for atopic dermatitis, phototherapy or topical therapy (other than moisturizer) within 1 week * medical condition which would make use of efalizumab unsafe; would limit compliance with study requirements; or would limit accurate assessment of efficacy. * ongoing, active, serious infection * history of malignancy (except excised basal or squamous cell carcinoma of the skin)

Keywords: eczema atopic dermatitis efalizumab
deep brain therapy with low-intensity ultrasound for generalized chronic pain

Conditions: Chronic Pain; Chronic Pain Syndrome; Widespread Chronic Pain

Summary: this study will evaluate a new form of non-invasive deep brain therapy for individuals with generalized chronic pain. low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. a well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. the trial will evaluate brain target engagement using magnetic resonance imaging and cvas and promis numerical rating scales of pain.


Eligibility criteria:
inclusion criteria: 1. age 18-65, any gender 2. primary diagnosis of generalized chronic pain or widespread chronic pain. 3. moderate-to-severe chronic pain lasting at least 2 months 4. stated willingness to comply with all study procedures and avoid changes to current treatments (medications, physical therapy, cognitive behavioral therapy) for the duration of the study 5. for females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study 6. capacity to provide informed consent; provision of a signed and dated consent form exclusion criteria: 1. history of serious brain injury or other neurologic disorder 2. poorly managed general medical condition 3. pregnant or breast feeding 4. implanted device in the head or neck 5. mri intolerance or contraindication 6. brain stimulation (e.g., vns, tms) in the past month 7. lifetime history of a serious suicide attempt (hooley et al., 2014) 8. clinically inappropriate for participation in the study as determined by the study team
the effects of glucocorticoids on mortality and renal function in patients with acute decompensated heart failure

Conditions: Heart Failure

Summary: evidence showed that glucocorticoids could induce potent diuretic actions and improve renal functions in patients with decompensated congestive heart failure. thus we design this study to determine the efficacy of glucocorticoids on cardiovascular mortality in the 30 days following randomization.

newly emerging clinical evidence showed glucocorticoids, when added to best conventional therapy, could produce potent diuretic effects, and improve renal functions in patients with decompensated congestive heart failure. it holds ture even in the patients who failed to respond to high dose of furosemide (\>200mg/day). the present study is to confirm the clinical efficacy of glucocorticoids on cardiovascular mortality in patients with decompensated congestive heart failure who are on best conventional therapy.

Eligibility criteria:
inclusion criteria: * patients with dyspnea at rest due to acutely decompensated chf requiring hospitalization and intravenous therapy. the cardiac etiology for acutely decompensated chf was established by echocardiogram and/or a chest x-ray film and 2 of the following: 1. \>2-pillow orthopnea before study entry 2. jugular venous distention and/or abdominal discomfort due to mesenteric congestion. patients may have had acute decompensation of chronic heart failure, gradual worsening of chronic heart failure, or new onset of acutely decompensated chf. patients who were receiving intravenous therapy i.e. inotropic and/or vasodilator but who otherwise met entry criteria were also permitted into the study. patients with signs of cardiac shock were also permitted into the study. exclusion criteria: * patient refusal * any signs of infection * any condition that would contraindicate a glucocorticoids use * poor controlled hypertension * poor controlled diabetes mellitus * active myocarditis * malignancy or other terminal illness

Keywords: heart failure prednisone cardiovascular mortality renal function
vaccine therapy in treating patients with chronic myelogenous leukemia

Conditions: Leukemia

Summary: rationale: vaccines made from a person's white blood cells may make the body build an immune response to kill cancer cells. purpose: phase i trial to study the effectiveness of vaccine therapy in treating patients who have chronic myelogenous leukemia.

objectives: * determine the feasibility of vaccination with autologous heat shock protein 70 in patients with chronic phase chronic myelogenous leukemia. * determine the toxicity of this vaccination in these patients. outline: patients undergo leukapheresis to obtain peripheral mononuclear cells (pmncs). heat shock protein 70 (hsp70) is derived from the autologous pmncs. patients receive hsp70 intradermally once weekly for 8 weeks. patients are followed for 2 weeks.

Eligibility criteria:
disease characteristics: * diagnosis of chronic phase chronic myelogenous leukemia * philadelphia chromosome positive * peripheral blast count no greater than 10% * no molecular remission * less than 3 years since initial diagnosis * no anticipation of requirement for bone marrow or stem cell transplantation for 6 months patient characteristics: age: * 18 and over performance status: * ecog 0-1 life expectancy: * not specified hematopoietic: * hemoglobin at least 10 g/dl * platelet count at least 20,000/mm\^3 hepatic: * bilirubin less than 2.0 times upper limit of normal (uln) * transaminase less than 2.0 times uln renal: * creatinine less than 2.0 mg/dl other: * not pregnant * negative pregnancy test * fertile patients must use effective contraception * no significant active infection requiring hospitalization * no other serious illness or significant behavioral or psychological problem that would preclude study involvement prior concurrent therapy: biologic therapy: * see disease characteristics * prior interferon alfa allowed * no concurrent interferon alfa chemotherapy: * prior cytarabine or other cytotoxic agents allowed * no concurrent cytarabine or other cytotoxic agents * concurrent hydroxyurea allowed endocrine therapy: * no concurrent corticosteroid therapy radiotherapy: * not specified surgery: * not specified other: * no concurrent immunosuppressive medications * concurrent imatinib mesylate allowed

Keywords: chronic phase chronic myelogenous leukemia chronic myelogenous leukemia, bcr-abl1 positive
oculogica portable eyebox study

Conditions: Concussion, Brain; Mild Traumatic Brain Injury

Summary: the objective of this study is to assess the accuracy of a portable version of the eyebox device, an eye-tracking based diagnostic, in comparison to a clinical reference standard of concussion. the utility of the portable assessment to aid in the monitoring of symptoms over time after an initial diagnosis of concussion will also be evaluated.


Eligibility criteria:
inclusion criteria: * 1. provide documented informed consent or assent along with guardian consent. * 2. have presented, at any time post injury, for any complaint related to an injury involving either a direct force to the head or a blow to the body that has the potential to transmit a rapid acceleration/deceleration of the head, with or without loss of consciousness, with or without external signs of head injury. * 3. be 5 to 67 years of age, inclusive. * 4. have the ability to provide a complete ophthalmologic, medical, and neurologic history as well as report current medications. exclusion criteria: * 1. have penetrating trauma or known skull fracture or intracranial injury. * 2. have had a conventional head ct or mri demonstrating evidence of structural brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read). * 3. any of the following conditions, immediately related to the incident injury: loss of consciousness exceeding 30 minutes or best available glasgow coma scale (gcs) score less than 13 within 24 hours or other acute conditions requiring emergency medical management. * 4. be blind (no light perception), have missing or non-functional eyes. * 5. be unable to open their eyes. * 6. have a history of unresolved strabismus, diplopia, amblyopia. * 7. have a history of unresolved cranial nerve iii, iv, or vi palsy. * 8. have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption. * 9. have a history of extensive prior eye surgery or scarring (examples include strabismus surgery, scleral buckle repair of retinal detachment, repair of blow out fractures of the orbit and any procedures that would interfere with extraocular muscle movements; prior cataract surgery or lasik are not exclusions). * 10. have a prior history of unresolved ocular-motor dysfunctions. * 11. be intoxicated.
somebody, a social media-based eating disorder prevention program

Conditions: Eating Disorder Symptom

Summary: the purpose of this study is to develop and evaluate the feasibility, acceptability, and preliminary evidence of potential efficacy of a social-media based intervention to reduce risk factors for eating disorders in college women.

previous research supports an association between specific aspects of social media use and increased eating pathology in correlational designs and that specific aspects of social media use cause increases in risk factors for eating disorders. the aim of the current project is to determine whether social media use can be altered to cause decreases in eating disorder risk factors. to accomplish this, college women will be recruited to participate in an open trial of a pilot program that adapts activities used within evidence-based eating disorder prevention programs to be used on social media platforms. the intervention is designed to target internalization of the thin ideal.

Eligibility criteria:
inclusion criteria: * female * 18 to 25 years old * score in the top 50th percentile for time spent on social media each day exclusion criteria: * male * \ 25 years old * individuals who screen positive for a diagnostic statistical manual-5 eating disorder on the eating disorder diagnostic scale
the role of vitamin d in predicting response to neoadjuvant therapy in patients with rectal cancer

Conditions: Rectal Cancer; Stage III Rectal Cancer

Summary: it has been reported that better local control is achieved and sphincters are preserved at a higher rate with curative resections performed after neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancers. in addition, it has been reported that local recurrence is reduced and survival is prolonged in patients with complete pathological response to neoadjuvant therapy. therefore, the importance of predicting patients with pathological complete response has increased. it has been reported that data obtained from pet-ct scans and clinical information such as tumor size, t stage, and n stage may be useful in predicting the response to neoadjuvant therapy in patients with locally advanced rectal cancer. consideration of blood biomarkers in predicting neoadjuvant response can be a very attractive option. because samples are easily collected, relatively inexpensive to measure, and contain information about different aspects of tumor biology. there are a limited number of blood biomarkers such as cea and il-6 that have been studied in the literature. experimental studies show that vitamin d suppresses inflammation and protects against cancer by triggering differentiation. in 1980, cedric and frank garland stated for the first time that vitamin d may affect the survival of the patient after the diagnosis of colorectal cancer. in later studies, a positive relationship was reported between the serum level of 25-hydroxyvitamin d - 25 (oh) d and survival rates for colorectal cancer, breast and prostate cancer. in addition, 25 (oh) d serum concentration has been shown to be inversely related to colorectal cancer progression. in the light of all these information, the role of serum vitamin d levels before neoadjuvant treatment in predicting pathological response in patients with rectal cancer is investigated in this study.


Eligibility criteria:
inclusion criteria: * • all patients with locally advanced rectal cancer exclusion criteria: * • below 18 years old * patients who did not received neoadjuvant therapy

Keywords: rectal cancer neoadjuvant vitamin d
assessing eye tracking features following sports-related concussion

Conditions: Traumatic Brain Injury

Summary: this proposal aims to describe the oculometric features present during king-devick (k-d) testing for subjects who experienced sports-related concussion. the investigators aim to better describe the underlying oculomotor anomalies present in this cohort that lead to increased k-d test time. understanding these anomalies will allow for better understanding of the effects of sports-related concussion and may provide a rapid and reliable metric for diagnosing concussion as well as monitoring long-term recovery.

this proposal aims to describe the oculometric features present during k-d testing for subjects who experienced sports-related concussion. the investigators aim to better describe the underlying oculomotor anomalies present in this cohort that lead to increased k-d test time. understanding these anomalies will allow for better understanding of the effects of sports-related concussion and may provide a rapid and reliable metric for diagnosing concussion as well as monitoring long-term recovery. the main objectives include: 1. describing the oculometric deficits present in subjects with acute sports-related concussion. 2. analyzing and quantifying the oculometric changes that occur during subject recovery. 3. identifying possible oculometric features as potential biomarkers that may lead to reliable, rapid method for recognizing acute concussion.

Eligibility criteria:
inclusion criteria: * over the age of 8 years, and able to provide informed consent / assent. * have documented diagnosis of sports-related concussion within two weeks of the event. * currently demonstrating post-concussion symptoms. exclusion criteria: - alcohol consumption within 48 hours of evaluation.

Keywords: concussion sports-related concussion mild traumatic brain injury (mtbi) eye tracking oculometrics
trial of celecoxib with preoperative chemo- radiation for locally advanced rectal cancer

Conditions: Locally Advanced Rectal Cancer

Summary: this is a single arm phase ii trial with combined celecoxib, tegafur-uracil, folinate and preoperative radiotherapy for patients with locally advanced rectal cancer. the primary end point is pathological complete response (pcr) rate. the secondary endpoints are toxicities of combined celecoxib and chemoradiation, negative resection margin rate, clinical tumor response by magnetic resonance imaging (mri), sphincter preservation rate, disease-free survival and overall survival.

the primary objective is to determine the pathological complete response (pcr) of combining preoperative tegafur-uracil, folinate, radiation and celecoxib for locally advanced rectal cancer. the secondary objectives of this study are to determine: 1. toxicity profile of combining celecoxib, tegafur-uracil, folinate and preoperative radiation for locally advanced rectal cancer. 2. negative resection margins (circumferential resection margin) rate. 3. downstaging rate. 4. sphincter preservation rate 5. locoregional and distant failure rate. 6. overall survival

Eligibility criteria:
inclusion criteria: 1. patients with resectable or potentially resectable adenocarcinoma of the rectum. 2. clinical stage by magnetic resonance image (mri) of pelvis, ultrasonography of liver and chest x ray: ajcc t2 n1-2m0 or t3-4 n0-2m0 (patients who require diverting loop colostomy are eligible). nuclear medicine study (whole body bone scan or pet scan) can be performed if clinically indicated. 3. bi-dimensionally measurable disease by mri, which can be done with pelvic array coil and intrarectal tube. 4. age greater than 18 years and \< 80 years, ecog performance status \< 2 5. biopsy proven adenocarcinoma, superior margin of the tumor below the l5-s1 spine junction. 6. wbc \> 3.5 x109/l, neutrophil count \> 1.5x109/l, platelet count \> 100x109/l, serum bilirubin \< 1.25xuln (upper limit of normal), ast/alt \< 3x uln, serum creatinine \< 1.25xuln. 7. informed consent signed. exclusion criteria: 1. distant metastasis, prior pelvic irradiation, inflammatory bowel disease, medical conditions which preclude radical therapy. 2. history of malignancy within five years (except nonmelanoma skin cancer, cin cervix). 3. pregnancy. 4. hypersensitivity to celecoxib, nsaid, sulfonamides or 5-fu. 5. cardiovascular disease like congestive heart failure, symptomatic coronary artery disease, or myocardiac infarction. 6. history of peptic ulcer disease or nsaid-related gastrointestinal bleeding 7. use of aspirin, other nsaid or celecoxib in the two weeks prior to study entry. 8. patients taking warfarin or other anticoagulating medicine.
evaluation of a claims-based algorithm for the identification of transthyretin-mediated amyloidosis (attr) amyloidosis in medical records

Conditions: Transthyretin Amyloidosis

Summary: the primary objective of this study is to evaluate the diagnostic performance of an algorithm in identifying patients with attr amyloidosis.

a screening strategy to identify attr in the large background population of patients with one or more common attr manifestations, would be of significant clinical value. in addition, novel attr therapies have been recently made available or are currently in development in late-stage clinical trials. as early diagnosis and treatment is expected to achieve better outcomes, this makes the development and validation of an easily implemented, rapid and electronically-enabled diagnostic algorithm especially important. a medical and pharmacy claims-based algorithm was developed to potentially identify patients at risk of having attr. the goal of this study is to evaluate the ability of the algorithm to identify patients with attr by performing diagnostic clinical work up in patients that the algorithm identifies in a large dataset of patients at yale. the primary objective of this study is to evaluate the diagnostic performance of the algorithm in identifying patients with attr amyloidosis. the secondary objective of this study is to estimate the clinical benefit of the algorithm, as measured by the added diagnostic value, i.e. the proportion or rate of patients who were previously undiagnosed. the total obtained prevalence will be assessed and informally compared to the referral-based prevalence of attr amyloidosis patients at yale.

Eligibility criteria:
inclusion criteria: * identified by the attr diagnostic algorithm and matched by yale's list of potential subjects defined as: 1. subjects within the claims dataset that are predicted to be at risk of having attr who are also being managed within ynhhs 2. patients who need to be contacted and offered additional clinical evaluation to determine whether they have a diagnosis of attr (non-hereditary or hereditary attr amyloidosis). exclusion criteria: * patients who have opted out of research in the epic system will be excluded entirely from the study * patients who are pregnant or who may become pregnant